To investigate efficacy and safety of liraglutide vs placebo for weight management in adults with overweight or obesity and type @ diabetes .


Fifty-six-week randomized ( @:@:@ ) , double-blind , placebo-controlled , parallel-group trial with @-week observational off-drug follow-up period .


The study was conducted at @ sites in @ countries between June @ and January @ .


Of @ participants assessed for eligibility , @ were randomized .


Inclusion criteria were body mass index of @ or greater , age @ years or older , taking @ to @ oral hypoglycemic agents ( metformin , thiazolidinedione , sulfonylurea ) with stable body weight , and glycated hemoglobin level @ % to @ % .


Once-daily , subcutaneous liraglutide ( @ mg ) ( n = @ ) , liraglutide ( @ mg ) ( n = @ ) , or placebo ( n = @ ) , all as adjunct to @ kcal/d dietary deficit and increased physical activity ( @ min/wk ) .


Three coprimary end points : relative change in weight , proportion of participants losing @ % or more , or more than @ % , of baseline weight at week @ .


Baseline weight was @ kg with liraglutide ( @-mg dose ) , @ kg with liraglutide ( @-mg dose ) , and @ kg with placebo .


Weight loss was @ % ( @ kg ) with liraglutide ( @-mg dose ) , @ % ( @ kg ) with liraglutide ( @-mg dose ) , and @ % ( @ kg ) with placebo ( estimated difference for liraglutide -LSB- @ mg -RSB- vs placebo , -@ % -LSB- @ % CI , -@ % to -@ % -RSB- ; liraglutide -LSB- @ mg -RSB- vs placebo , -@ % -LSB- @ % CI , -@ % to -@ % -RSB- ; P < @ for both ) .


Weight loss of @ % or greater occurred in @ % with liraglutide ( @ mg ) and @ % with liraglutide ( @ mg ) vs @ % with placebo ( estimated difference for liraglutide -LSB- @ mg -RSB- vs placebo , @ % -LSB- @ % CI , @ % to @ % -RSB- ; for liraglutide -LSB- @ mg -RSB- vs placebo , @ % -LSB- @ % CI , @ % to @ % -RSB- ; P < @ for both ) .


Weight loss greater than @ % occurred in @ % with liraglutide ( @ mg ) and @ % with liraglutide ( @ mg ) vs @ % with placebo ( estimated difference for liraglutide -LSB- @ mg -RSB- vs placebo , @ % -LSB- @ % CI , @ % to @ % -RSB- , P < @ ; for liraglutide -LSB- @ mg -RSB- vs placebo , @ % -LSB- @ % CI , @ % to @ % -RSB- , P = @ ) .


More gastrointestinal disorders were reported with liraglutide ( @ mg ) vs liraglutide ( @ mg ) and placebo .


No pancreatitis was reported .


Among overweight and obese participants with type @ diabetes , use of subcutaneous liraglutide ( @ mg ) daily , compared with placebo , resulted in weight loss over @ weeks .


Further studies are needed to evaluate longer-term efficacy and safety .


To investigate the association between consecutively measured thromboelastographic ( TEG ) tracings and outcome in patients with severe sepsis .


Multicentre prospective observational study in a subgroup of the Scandinavian Starch for Severe Sepsis/Septic Shock ( @S ) Trial ( NCT@ ) comparing hydroxyethyl starch ( HES ) @/@ @ vs. Ringer 's acetate for fluid resuscitation in severe sepsis .


TEG ( standard and functional fibrinogen ) was measured consecutively for @ days , and clinical data including bleeding and death was retrieved from the trial database .


Statistical analyses included Cox regression with time-dependent covariates and joint modelling techniques .


Of @ eligible patients , we analysed @ patients with TEG data .


At @ days , @ ( @ % ) had bled and @ ( @ % ) had died .


For all TEG variables , hypocoagulability according to the reference range was significantly associated with increased risk of death .


In a linear model , hazard ratios for death were @ ( @ % confidence interval , @-@ @ ) for increased clot formation speed , @ ( @-@ @ ) for decreased angle , @ ( @-@ @ ) for decreased clot strength and @ ( @-@ @ ) for decreased fibrinogen contribution to clot strength ( functional fibrinogen MA ) , showing that deterioration towards hypocoagulability in any TEG variable significantly increased the risk of death .


Patients treated with HES had lower functional fibrinogen MA than those treated Ringer 's acetate , which significantly increased the risk of subsequent bleeding -LSB- HR @ ( @-@ @ ) -RSB- and possibly explained the excess bleeding with HES in the @S trial .


In our cohort of patients with severe sepsis , progressive hypocoagulability defined by TEG variables was associated with increased risk of death and increased risk of bleeding .


Knowledge about the effects of exercise in severe and endstage osteoarthritis ( OA ) is limited .


The aim was to evaluate the efficacy of a neuromuscular exercise program in patients with clinically severe hip or knee OA .


This was a randomized controlled assessor-blinded trial .


Patients received an educational package ( care-as-usual ) only , or care-as-usual plus an @-week neuromuscular exercise intervention ( NEMEX-TJR ) .


NEMEX-TJR was supervised by a physiotherapist , twice weekly for @ h.


The primary outcome was Activities of Daily Living ( ADL ) subscale from the Hip disability and Osteoarthritis Outcome Score ( HOOS ) and the Knee Injury and Osteoarthritis Outcome Score ( KOOS ) questionnaire .


The secondary outcomes were the HOOS/KOOS subscales Pain , Symptoms , Sport and Recreation , and Joint-related Quality of Life .


Exploratory outcomes were functional performance measures and lower limb muscle power .


Included were @ patients , @ % female , average age @ years ( SD @ ) , and a body mass index of @ ( SD @ ) , who were scheduled for primary hip or knee replacement .


The postintervention difference between mean changes in ADL was @ points ( @ % CI @ to @ , p = @ ) in favor of NEMEX-TJR compared with control .


Second , there were statistically significant differences between groups in favor of NEMEX-TJR on all self-reported outcomes and most functional performance tests ( walk , chair stands , and @-leg knee bends ) .


Stratified analyses according to joint revealed moderate effect size for ADL for hip patients ( @ , @ % CI @ to @ ) .


Corresponding effect size for knee patients was small ( @ @ % CI -@ to @ ) .


Feasibility of neuromuscular exercise was confirmed in patients about to have total joint replacement .


Self-reported activities of daily living and objective performance were improved and pain reduced immediately following @ weeks of neuromuscular exercise .


While the effects were moderate in hip OA , they were only small in knee OA .


ClinicalTrials.gov Identifier : NCT@ .


Clinical effectiveness of previous regimens to treat Plasmodium vivax infection have been hampered by compliance .


We aimed to assess the dose-response , safety , and tolerability of single-dose tafenoquine plus @-day chloroquine for P vivax malaria radical cure .


In this double-blind , randomised , dose-ranging phase @b study , men and women ( aged @ years ) with microscopically confirmed P vivax monoinfection ( parasite density > @ to < @,@ per L blood ) were enrolled from community health centres and hospitals across seven sites in Brazil , Peru , India , and Thailand .


Patients with glucose-@-phosphate dehydrogenase enzyme activity of less than @ % were excluded .


Eligible patients received chloroquine ( days @-@ ) and were randomly assigned ( @:@:@:@:@:@ ) by a computer-generated randomisation schedule to receive single-dose tafenoquine @ mg , @ mg , @ mg , or @ mg , primaquine @ mg for @ days , or chloroquine alone .


Randomisation was stratified by baseline parasite count ( @ and > @ per L blood ) .


The primary efficacy endpoint was relapse-free efficacy at @ months from initial dose ( ie , clearance of initial infection without subsequent microscopically confirmed infection ) , analysed by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT@ .


Between Sept @ , @ , and March @ , @ , @ patients were randomly assigned to a treatment group ( chloroquine plus tafenoquine @ mg -LSB- n = @ -RSB- , @ mg -LSB- n = @ -RSB- , @ mg -LSB- n = @ -RSB- , @ mg -LSB- n = @ -RSB- ; or to chloroquine plus primaquine -LSB- n = @ -RSB- ; or chloroquine alone -LSB- n = @ -RSB- ) .


Relapse-free efficacy at @ months was @ % ( @ % CI @-@ ) with tafenoquine @ mg , @ % ( @-@ ) with tafenoquine @ mg , @ % ( @-@ ) with tafenoquine @ mg , @ % ( @-@ ) with tafenoquine @ mg , @ % ( @-@ ) with primaquine , and @ % ( @-@ ) with chloroquine alone .


Tafenoquine @ mg and @ mg had better efficacy than chloroquine alone ( treatment differences @ % -LSB- @ % CI @-@ -RSB- , p < @ , with tafenoquine @ mg and @ % -LSB- @-@ -RSB- , p < @ , with tafenoquine @ mg ) , as did primaquine ( treatment difference @ % -LSB- @-@ -RSB- , p = @ ) .


Adverse events were similar between treatments .


@ serious adverse events occurred in @ ( @ % ) of @ patients ; QT prolongation was the most common serious adverse event ( @ -LSB- @ % -RSB- of @ ) , occurring in five ( @ % ) of @ patients receiving tafenoquine , four ( @ % ) of @ patients receiving primaquine , and two ( @ % ) of @ patients receiving chloroquine alone , with no evidence of an additional effect on QT of chloroquine plus tafenoquine coadministration .


Single-dose tafenoquine @ mg coadministered with chloroquine for P vivax malaria relapse prevention was more efficacious than chloroquine alone , with a similar safety profile .


As a result , it has been selected for further clinical assessment in phase @ .


To compare the effects of a combination of therapeutic exercise and ultrasound with or without additional microcurrent therapy in infants with congenital muscular torticollis involving the entire sternocleidomastoid muscle .


Prospective , randomized , placebo-controlled trial .


An outpatient rehabilitation clinic in a tertiary university hospital .


Infants ( n = @ ) with congenital muscular torticollis involving the entire sternocleidomastoid muscle .


Group @ comprised @ infants who received therapeutic exercise with ultrasound alone and Group @ comprised @ infants who received the same treatment with microcurrent therapy .


Passive cervical rotational range of motion was measured at before treatment and one , two , three , and six months after initial treatment .


Thickness , cross-sectional area , and red pixel intensity on colour histograms , which were all assessed before treatment and at three months after initial treatment .


Additionally , the duration of treatment was measured .


The mean passive cervical rotational range of motion measured at three months posttreatment was significantly greater in Group @ ( @ ) than that in Group @ ( @ ) , and the thickness , cross-sectional area , and red pixel intensity of the affected sternocleidomastoid muscle were all less in Group @ ( @ mm , @ mm ( @ ) , and @ , respectively ) than those in Group @ ( @ mm , @ mm@ , and @ , respectively ) .


The mean duration of treatment was significantly shorter in Group @ ( @ months ) than in Group @ ( @ months ) .


Microcurrent therapy may increase the efficacy of therapeutic exercise with ultrasound for the treatment of congenital muscular torticollis involving the entire sternocleidomastoid muscle .


Decreases in the bioavailability of rifampicin ( RFP ) can lead to the development of drug resistance and treatment failure .


Therefore , we investigated the relative bioavailability of RFP from one four-drug fixed-dose combination ( FDC ; formulation A ) and three two-drug FDCs ( formulations B , C , and D ) used in China , compared with RFP in free combinations of these drugs ( reference ) , in healthy volunteers .


Eighteen and twenty healthy Chinese male volunteers participated in two open-label , randomized two-period crossover ( formulations A and C ) or one three-period crossover ( formulations B and D ) study , respectively .


The washout period between treatments was @ days .


Bioequivalence was assessed based on @ % confidence intervals , according to two one-sided t-tests .


All analyses were done with DAS @ ( Mathematical Pharmacology Professional Committee of China , Shanghai , China ) .


Mean pharmacokinetic parameter values of RFP obtained for formulations A , B , C , and D products were @ @ g/ml , @ @ g/ml , @ @ g/ml , and @ @ g/ml , respectively , for peak plasma concentration ( C max ) , @ @ gh-@ml-@ , @ @ gh-@ml-@ , @ @ gh-@ml-@ , @ @ gh-@ml-@ , respectively , for area under the concentration-time curve ( AUC @-@ h ) .


Although the concentrations of RFP for formulations A , C , and D were within the reported acceptable therapeutic range , only formulation A was bioequivalent to the reference product .


The three two-drug FDCs ( formulations B , C and D ) displayed inferior RFP bioavailability compared with the reference ( Chinese Clinical Trials registration number : ChiCTR-TTRCC-@ ) .


Our aim was to ascertain the efficacy of golimumab compared with placebo in the prevention of atherosclerosis and arterial stiffness in AS .


A randomized , double-blind , placebo-controlled pilot study was performed in which AS patients were treated with golimumab ( n = @ ) and placebo ( n = @ ) for @ months .


Patients from the placebo group who failed to achieve a @ % response to Assessment of SpondyloArthritis international Society criteria ( ASAS@ ) at @ months received open-label golimumab .


Intima-media thickness ( IMT ) , pulse wave velocity ( PWV ) and augmentation index ( AIx ) were measured at baseline , @ and @ months .


At @ months , @/@ ( @ % ) and @/@ ( @ % ) patients from the golimumab and placebo groups achieved an ASAS@ response , respectively ( P = @ ) .


There was no significant difference in the change of the vascular parameters between the two groups .


In the placebo group , significantly greater progression of the mean IMT -LSB- from @ mm ( S.D. @ ) at baseline to @ mm ( S.D. @ ) at @ months , P = @ -RSB- and PWV ( from @ m/s ( S.D. @ ) at baseline to @ m/s ( S.D. @ ) , P = @ -RSB- were observed .


There was a trend towards progression of the mean IMT in the golimumab group ( P = @ ) but the maximum IMT , PWV and AIx remained unchanged .


At @ months the changes in vascular parameters were similar between the early and delayed ( or no ) golimumab groups .


Uncontrolled inflammation may result in a significant progression in IMT and PWV in patients with AS .


Arterial dysfunction may be prevented by golimumab over a period of @ months , probably because of effective suppression of inflammation .


This study investigated the dietary effect of including pigmented rice bran with or without plant sterols on lipid profiles during energy restriction-induced weight loss in overweight and obese adults not taking cholesterol-lowering medication .


In addition , the study examined the effect of intervention on biomarkers of oxidative stress and inflammation .


A group of @ overweight and obese adults ( age : @ @ years , body mass index @ @ kg/m ( @ ) , @ females ) were randomized to a @ % calorie-restricted diet containing either pigmented rice bran ( RB ) or the RB with addition of plant sterols ( RB+PS ) snack bars for @ weeks .


The individualized nutrient-balanced diet contained @ % of daily energy needs assessed from indirect calorimetry measured resting energy expenditure ( EE ) and physical activity-related EE assessed using accelerometry .


Anthropometrics , blood pressure , blood lipids , glucose , urinary F@-isoprostanes , C-reactive protein , insulin , and leptin were measured at baseline and after @ weeks of intervention .


Participants lost approximately @ @ kg ( p < @ ) .


Weight loss was not significant between the RB+PS and RB group ( p = @ ) .


Changes in body fat corresponded to changes in body weight .


Average decrease in total cholesterol was significantly higher in the RB+PS group than in the RB group ( difference @ @ g/dL vs @ @ g/dL ; p = @ ) .


A similar pattern was observed for the decrease in low-density lipoprotein ( LDL ) cholesterol ( difference @ @ g/dL vs @ @ g/dL ; p = @ ) .


Changes in systolic blood pressure , serum levels of leptin , and F@-isoprostanes were significant between baseline values and after @ weeks on the diet in both groups ( p < @ ) but did not differ between the @ groups .


A nutrient-balanced and energy-restricted diet supplemented with rice bran and plant sterols resulted in a significant decrease in total and LDL cholesterol in overweight and obese adults .


To evaluate efficacy and safety of Baimai ointment ( see symbol in text ) in the treatment of wrist-dysfunction after distal radius fracture .


From April , @ to June , @ , @ patients with distal radius fracture were treated with plaster fixation .


All the patients were divided into two group : test group and control group .


Twenty-one patients in test group and @ in control group , and the baseline was balance ( P > @ ) .


The @ patients in test group were treated with Baimai ointment ( see symbol in text ) , fomentation , functional exercises .


The @ patients in control group were treated with placebo , fomentation , functional exercises .


Foment affected side wrist with wet towel in @ min before medication , with the temperature between @ degrees C and @ degrees C. Smear drugs uniformly in range of @ cm in the vicinity of palm stripes after drying ( about @ g ) and take functional exercises for the activities of wrist and hand .


Continuous follow the program per @ hours once and follow-up for @ weeks .


The Wrist 's pain was assessed with VAS .


The wrist 's activities were measured with the protractor of orthopedic .


Measure The grip strength was measured with dynamometer .


The wrist 's function were assessed with the table of Cooney .


The test group had a significantly better results than those of control group in the extent of wrist 's pain throughout the treatment ( P < @ ) , and grip strength on the @th day and the @th day ( P < @ ) , and Cooney functional assessment on the @th day ( P < @ ) .


Wrist 's activities had no significane difference throughout the @ weeks ( P > @ ) .


There were no drug adverse reactions occurred .


Tibetan Baimai ointment ( see symbol in text ) has the treatment of wrist-dysfunction after distal radius fracture for external use , which can reduce the extent of wrist 's pain , promote grip strength recovery in the middle and late of process , promote wrist 's function recovery latterly , and safety for external use .


This study aimed to investigate the effect of both history of intermittent atrial tachyarrhythmias ( IAT ) and in-trial IAT on the risk of heart failure ( HF ) or death comparing cardiac resynchronization therapy with defibrillator ( CRT-D ) to implantable cardioverter-defibrillator ( ICD ) treatment in mildly symptomatic HF patients with left bundle branch block ( LBBB ) .


Limited data exist regarding the benefit of CRT-D in patients with IAT .


The benefit of CRT-D in reducing the risk of HF/death was evaluated using multivariate Cox models incorporating the presence of , respectively , a history of IAT at baseline and time-dependent development of in-trial IAT during follow-up in @,@ patients with LBBB enrolled in the MADIT-CRT ( Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ) study .


The overall beneficial effect of CRT-D versus ICD on the risk of HF/death was not significantly different between LBBB patients with or without history of IAT ( HR : @ , p = @ , and HR : @ , p < @ , respectively ; p for interaction = @ ) .


Among patients who had in-trial IAT , CRT-D was associated with a significant @ % reduction in the risk of HF/death compared with ICD-only therapy ( HR : @ , p = @ ) , similar to the effect of the device among patients who did not have IAT ( HR : @ , p < @ ; p for interaction = @ ) .


The percentage of patients with biventricular pacing @ % was similar in both groups ( p = @ ) .


Consistent results were shown for the benefit of CRT-D among patients who had in-trial atrial fibrillation/flutter ( HR : @ , p = @ ; p for interaction = @ ) .


In the MADIT-CRT study , the clinical benefit of CRT-D in LBBB patients was not attenuated by prior history of IAT or by the development of in-trial atrial tachyarrhythmias .


( MADIT-CRT : Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy ; NCT@ ) .


QVA@ is a novel , inhaled , once-daily dual bronchodilator containing a fixed-dose combination of the long-acting @-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium ( NVA@ ) , for the treatment of chronic obstructive pulmonary disease ( COPD ) .


This study evaluated the effects of QVA@ on exercise tolerance , hyperinflation , lung function and lung volumes versus placebo and tiotropium .


Patients with moderate-to-severe COPD were randomized to QVA@ @/@ g , placebo or tiotropium @ g once daily in a blinded , @-period crossover study for @ weeks .


The primary endpoint was exercise endurance time at Day @ for QVA@ versus placebo .


Eighty-five patients were randomized ; @ % completed the study .


QVA@ significantly improved exercise endurance time at Day @ compared with placebo ( least squares mean treatment difference @ s -LSB- p = @ -RSB- ) .


No significant improvements in exercise endurance time at Day @ between QVA@ and tiotropium were found .


Dynamic inspiratory capacity ( IC ) at exercise isotime , trough forced expiratory volume in @ s , residual volume and functional residual capacity showed significant improvements with QVA@ from Day @ of treatment that were maintained throughout the study .


The safety profiles were similar across groups .


In patients with moderate-to-severe COPD , once-daily QVA@ significantly improved exercise endurance time compared with placebo which was associated with sustained reductions of lung hyperinflation as indicated by significant improvement in IC at rest and during exercise .


ClinicalTrials.gov NCT@ .


Dual bronchodilation with QVA@ decreases lung hyperinflation and improves exercise tolerance and lung function in patients with moderate-to-severe COPD .


Persons with type @ diabetes mellitus ( T@DM ) are at increased risk for decline in cognitive function , reduced brain volume , and increased white matter lesions in the brain .


Poor control of blood pressure ( BP ) and lipid levels are risk factors for T@DM-related cognitive decline , but the effect of intensive treatment on brain function and structure is unknown .


To examine whether intensive therapy for hypertension and combination therapy with a statin plus a fibrate reduces the risk of decline in cognitive function and total brain volume ( TBV ) in patients with T@DM .


A North American multicenter clinical trial including @ participants without baseline clinical evidence of cognitive impairment or dementia and with hemoglobin A@c ( HbA@c ) levels less than @ % randomized to a systolic BP goal of less than @ vs less than @ mm Hg ( n = @ ) or to a fibrate vs placebo in patients with low-density lipoprotein cholesterol levels less than @ mg/dL ( n = @ ) .


Participants were recruited from August @ , @ , through October @ , @ , with the final follow-up visit by June @ , @ .


Cognition was assessed at baseline and @ and @ months .


A subset of @ participants underwent baseline and @-month brain magnetic resonance imaging to assess for change in TBV and other structural measures of brain health .


Baseline mean HbA@c level was @ % ; mean age , @ years ; and mean duration of T@DM , @ years .


At @ months , no differences in cognitive function were found in the intensive BP-lowering trial or in the fibrate trial .


At @ months , TBV had declined more in the intensive vs standard BP-lowering group ( difference , -@ -LSB- @ % CI , -@ to -@ -RSB- cm ( @ ) ; P = @ ) .


Fibrate therapy had no effect on TBV compared with placebo .


In participants with long-standing T@DM and at high risk for cardiovascular events , intensive BP control and fibrate therapy in the presence of controlled low-density lipoprotein cholesterol levels did not produce a measurable effect on cognitive decline at @ months of follow-up .


Intensive BP control was associated with greater decline in TBV at @ months relative to standard therapy .


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT@ .


Providing women with contraceptive methods following abortion is important to reduce repeat abortion rates , yet evidence for effective post-abortion family planning interventions are limited .


This protocol outlines the evaluation of a mobile phone-based intervention using voice messages to support post-abortion family planning in Cambodia .


A single blind randomised controlled trial of @ participants .


Clients aged @ or over , attending for abortion at four Marie Stopes International clinics in Cambodia , owning a mobile phone and not wishing to have a child at the current time are randomised to the mobile phone-based intervention or control ( standard care ) with a @:@ allocation ratio.The intervention comprises a series of six automated voice messages to remind clients about available family planning methods and provide a conduit for additional support .


Clients can respond to message prompts to request a phone call from a counsellor , or alternatively to state they have no problems .


Clients requesting to talk to a counsellor , or who do not respond to the message prompts , receive a call from a Marie Stopes International Cambodia counsellor who provides individualised advice and support regarding family planning .


The duration of the intervention is @ months .


The control group receive existing standard of care without the additional mobile phone-based support.We hypothesise that the intervention will remind clients about contraceptive methods available , identify problems with side effects early and provide support , and therefore increase use of post-abortion family planning , while reducing discontinuation and unsafe method switching.Participants are assessed at baseline and at @ months .


The primary outcome measure is use of an effective modern contraceptive method at @ months post abortion .


Secondary outcome measures include contraception use , pregnancy and repeat abortion over the @-month post-abortion period.Risk ratios will be used as the measure of effect of the intervention on the outcomes , and these will be estimated with @ % confidence intervals .


All analyses will be based on the ` intention to treat ' principle .


This study will provide evidence on the effectiveness of a mobile phone-based intervention using voice messages to support contraception use in a population with limited literacy .


Findings could be generalisable to similar populations in different settings .


Cognitive-behavioural treatment can nowadays be delivered through the Internet .


This form of treatment can have various advantages with regard to availability and accessibility .


Previous studies showed that Internet-based treatment for chronic pain is effective compared to waiting-list control groups .


We conducted a randomized controlled trial comparing an Internet-based cognitive-behavioural intervention with e-mail therapist contact to a face-to-face cognitive-behavioural group intervention .


Of the @ participants who were randomly assigned to an Internet or a group course , @ participants completed the intervention .


Participants were assessed at baseline ( T@ ) , immediately after the @-week course ( T@ ) and at the booster session @ months later ( T@ ) .


Pain-related catastrophizing was the primary outcome measure .


Pain intensity , fatigue , pain-related interference , locus of control , pain coping , global health-related quality of life and medical expenses were secondary outcome variables .


Significant improvement was found on catastrophizing , pain coping , locus of control and aspects of global health-related quality of life in both the Internet and the group courses directly after the course and at the booster session .


Pain intensity was improved in both courses at the booster session .


At T@ , improvement in catastrophizing , pain intensity , pain coping and some quality of life dimensions was significantly greater in completers of the Internet course than in the group course .


Furthermore , the Internet course was cost-effective compared to the group course .


We conclude that the Internet-based cognitive-behavioural intervention was at least as effective as the face-to-face group intervention and , on some outcome measures appeared to be even more effective .


To describe the prevalence and risk factors for incomplete bladder emptying after midurethral slings ( MUS ) in a large multicenter trial .


Five hundred ninety-seven women were randomized to retropubic ( RMUS ) or transobturator midurethral slings as part of the Trial of MidUrethral Slings study .


Demographic data and voiding symptoms were obtained preoperatively along with urodynamics .


Patients underwent a standardized voiding trial at discharge after continence surgery .


Incomplete bladder emptying was defined as a postvoid residual of > @ mL .


Three-quarters of patients ( @ of @ ) were self-voiding at discharge , whereas @ of @ ( @ % ) were managed with an indwelling urethral catheter and @ of @ ( @ % ) with intermittent catheterization .


At @ weeks , only @ of @ ( @ % ) reported any catheter use , and by @ weeks , only @ of @ ( @ % ) reported any catheter use .


Women with incomplete bladder emptying at discharge were more likely to have had a RMUS ( odds ratio @ ; @ % confidence interval @-@ @ ) and to report preoperative voiding accommodations such as straining to void ( odds ratio @ ; @ % confidence interval @-@ @ ) .


Urodynamic and clinicodemographic parameters were not predictive of incomplete bladder emptying .


Incomplete bladder emptying at discharge after MUS is common , especially after RMUS , but of short duration .


Risk factors include preoperative voiding accommodations such as straining or bending over to void , but other variables including urodynamics did not predict incomplete bladder emptying after MUS .


The prevalence and socioeconomic cost of late life depression ( LLD ) is on the rise , while the response rate to antidepressant trials remains poor .


Various mind-body therapies are being embraced by patients as they are considered safe and potentially effective , yet little is known regarding the effectiveness of such therapies to improve LLD symptoms .


Among the mind-body therapies currently in practice , the results of our pilot study have shown that a particular meditation technique called Sahaj Samadhi Meditation , which belongs to the category of meditation termed automatic self-transcending meditation ( ASTM ) may have some promise in improving cardiovascular autonomic disturbances associated with LLD as well as ameliorating symptoms of depression and anxiety .


Patients between the ages of @ and @ with LLD will be randomized either to ASTM plus treatment as usual ( TAU ) or TAU alone to assess changes in cardiovascular autonomic parameters , neuropsychological symptoms of depression and anxiety as well as quality of life .


The instructional phase of the intervention consists of @ consecutive days of meditation training , after which participants are encouraged to meditate twice daily for twenty minutes each time at home .


The intervention also includes once weekly follow up sessions for the subsequent @ weeks .


The planned study has one and a half year recruitment period .


Participants will be assessed at baseline and at @ , @ , @ and @ weeks post intervention .


This study should provide a unique data source from a randomized , controlled , longitudinal trial to investigate the effects of a form of ASTM on cardiovascular autonomic and neuropsychological health in LLD .


Acupuncture is safe and may be effective for severe chronic constipation .


The World Gastroenterology Organisation recommends prucalopride for patients for whom previous laxative use failed to provide satisfactory relief .


In this prospective , multi-centre , randomised controlled trial , five hundred sixty patients with severe chronic constipation ( two or less spontaneous complete bowel movements per week ) from @ centres will be randomised to receive either electroacupuncture or prucalopride .


Participants in the electroacupuncture group will receive electroacupuncture for eight weeks , while participants in the control group will take prucalopride ( @ mg once daily ) for @ weeks .


The primary outcome measure is the proportion of patients having @ spontaneous , complete bowel movements per week , averaged over week three to eight .


The secondary outcome measures include eight items , including the proportion of patients having @ spontaneous , complete bowel movements per week averaged over week @-@ , the proportion of patients with one or more increases in spontaneous , complete bowel movements per week from baseline , mean Bristol Stool Scale , etc. .


Statistical analysis will include the CMH test , nonparametric tests and t tests .


We aimed to compare the effect of electroacupuncture versus prucalopride for severe chronic constipation .


The limitation of this study is that participants and acupuncturists will not be blinded .


It was investigated whether oral dexamethasone ( DEX ) administration improves exercise performance by reducing the initial rate of muscle fatigue development during dynamic exercise .


Using a double-blinded placebo controlled randomized crossover design , subjects ingested either @ @ mg of DEX or placebo for five consecutive days .


Muscle function was investigated using one-legged kicking exercise and whole body performance was evaluated using a @-m shuttle run and a @-m sprint test .


One-legged dynamic knee-extensor exercise time to exhaustion was @ @ % ( mean SD ) longer ( P < @ ) in DEX compared to Placebo .


Likewise , total running distance in the shuttle run test was @ @ % longer ( P < @ ) , whereas @-m sprint performance was unaltered .


During the initial @ s of dynamic leg extensions , peak force and rate of force development determined from an electrically evoked twitch declined in a similar way in DEX and placebo .


Similarly , the EMG root mean square was similar with DEX and placebo treatment .


Short-term dexamethasone administration increases high-intensity one-legged kicking time to exhaustion and @-m shuttle run performance , although sprint ability and the initial loss of muscular force generating capacity are similar after DEX and placebo .


The aim of the present study was to determine ( @ ) whether successful intraoperative electromyography monitoring for lateral spread response ( LSR ) is possible with partial neuromuscular blockade ( NMB ) in subjects undergoing microvascular decompression ( MVD ) for hemifacial spasm and ( @ ) the adequate level of NMB to achieve that goal .


A total of @ patients in whom LSR was monitored during MVD were enrolled in the study .


Patients were randomly allocated to two groups : group TOF in which the NMB target was maintenance of two train-of-four ( TOF ) counts and group T@ in which the NMB target was maintenance of a T@/Tc ratio of @ % ( T@ : first twitch height of TOF and Tc : control twitch height ) .


The adductor pollicis brevis muscle was used to monitor TOF responses .


The frequency of successful LSR monitoring , defined as successful baseline establishment and maintenance of LSR until surgical decompression , was compared between the two groups .


Of the @ patients @ were excluded from the study so that @ patients in group TOF and @ patients in group T@ were analyzed .


The success rate of LSR monitoring was clinically acceptable and significantly higher in group T@ than in group TOF , i.e. n = @ ( @ % ) in group TOF versus n = @ ( @ % ) in group T@ ( P = @ ) , corresponding to a @ % higher success rate in group T@ than group TOF ( @ % CI : @-@ @ % ) .


Mean vecuronium infusion dose was smaller and mean TOF count was higher in group T@ than group TOF with a TOF count = @ ( @ ) in group TOF versus @ ( @ ) in group T@ ( P = @ ) .


Mean sevoflurane and remifentanil infusion doses were not different between groups .


There was no incidence of spontaneous movement during microscopy in either group .


Maintenance of partial NMB with a target T@/Tc ratio of @ % resulted in a clinically acceptable success rate of LSR monitoring and surgical condition during MVD .


Maintenance of partial NMB with a target T@/Tc ratio of @ % rather than TOF count of two during LSR monitoring for MVD can therefore be recommended .


The United States spends a higher percentage of its gross domestic product on health care than any other country .


Previous efforts to curtail health care spending have had minimal impact .


We hypothesized that informing physicians of the cost of expensive cardiovascular diagnostic tests would change their ordering behavior .


Hospitalist physicians ( n = @ ) were randomly assigned to either seeing or not seeing the cost of diagnostic tests , via a computer pop-up screen , at the time of order entry .


Patients were inpatients on a general medical service .


Cost-aware physicians were shown the cost of the test they ordered as well as the cost of similar tests with different costs .


There was a @-month baseline period prior to randomization followed by a @-month intervention period .


The primary outcome measure was a change in the proportion of imaging stress tests in the study period .


Of the total number of stress tests ordered ( imaging and nonimaging ) , cost-aware physicians ordered @ % of their tests with imaging during both the baseline and study periods .


Cost-unaware physicians ordered @ % imaging tests during the baseline period and @ % during the study period .


There were no significant differences between the groups regarding change in ordering from baseline to study period .


Both groups showed a slight increase ( P < @ ) in ordering the more expensive regadenoson nuclear stress tests ( cost-aware : @ % baseline , @ % study period ; cost-unaware : @ % baseline , @ % study period ) .


Informing physicians of the cost of certain diagnostic tests is not a sufficient intervention to influence their ordering behavior .


Clinical benefit response ( CBR ) , based on changes in pain , Karnofsky performance status , and weight , is an established palliative endpoint in trials for advanced gastrointestinal cancer .


We investigated whether CBR is associated with survival , and whether CBR reflects a wide-enough range of domains to adequately capture patients ' perception .


CBR was prospectively evaluated in an international phase III chemotherapy trial in patients with advanced pancreatic cancer ( n = @ ) in parallel with patient-reported outcomes ( PROs ) .


The median time to treatment failure was @ months ( range : @-@ ) .


The majority of the CBRs ( n = @ ) were noted in patients who received chemotherapy for at least @ months .


Patients with CBR ( n = @ ) had longer survival than non-responders ( n = @ ) ( hazard ratio = @ ; @ % confidence interval : @-@ @ ; p = @ ) .


CBR was predicted with a sensitivity and specificity of @-@ % by various combinations of @ mainly physical PROs .


A comparison between the duration of CBR ( n = @ , median = @ months , range = @-@ ) and clinically meaningful improvements in the PROs ( n = @-@ ; medians = @-@ months , range = @-@ ) showed similar intervals .


CBR is associated with survival and mainly reflects physical domains .


Within phase III chemotherapy trials for advanced gastrointestinal cancer , CBR can be replaced by a PRO evaluation , without losing substantial information but gaining complementary information .


MP@-@ ( Dymista ) , a novel intranasal formulation of azelastine hydrochloride ( AZE ) and fluticasone propionate ( FP ) , is significantly better than first-line therapy for the treatment of moderate-to-severe seasonal allergic rhinitis ( SAR ) , and is well tolerated following @ weeks of continuous use in chronic rhinitis .


The aim of this study was to evaluate the long-term efficacy of MP@-@ versus FP in patients with chronic rhinitis .


In total , @ chronic rhinitis patients ( perennial allergic rhinitis -LSB- PAR -RSB- , n = @ ; nonallergic rhinitis , n = @ ) aged @ years or older were enrolled into this open-label , parallel-group study and randomized to MP@-@ ( @ spray/nostril bid ) or FP nasal spray ( @ sprays/nostril qd ) for @ weeks .


Efficacy was assessed by change from baseline in PM reflective total nasal symptom score ( rTNSS ) , time to first achieve @ % PM rTNSS reduction from baseline , and percentage of symptom-free days in the total and PAR populations posthoc .


MP@-@ reduced patients ' PM rTNSS from baseline significantly more than FP , from Day @ up to and including week @ ( -@ vs -@ ; P = @ ) , with treatment difference maintained for @ weeks .


Fluctuation in significance after week @ might be explained , at least in part , by decreasing sample size , permitted according to ICH guidelines .


By Day @ almost twice as many MP@-@-patients were symptom free .


After @ month , @ % of MP@-@ patients experienced @ % rTNSS reduction ( @ % for FP ) , and did on a median of @ days faster ( P = @ ) .


Over @ weeks MP@-@ patients experienced @ % more symptom-free days ( P = @ ) .


These results were mirrored in the PAR subpopulation .


These results confirm MP@-@ 's wide therapeutic spectrum and assert its consistent superiority over an intranasal corticosteroid .


The clinical benefit of preventive eradication of unruptured brain arteriovenous malformations remains uncertain .


A Randomised trial of Unruptured Brain Arteriovenous malformations ( ARUBA ) aims to compare the risk of death and symptomatic stroke in patients with an unruptured brain arteriovenous malformation who are allocated to either medical management alone or medical management with interventional therapy .


Adult patients ( @ years ) with an unruptured brain arteriovenous malformation were enrolled into this trial at @ clinical sites in nine countries .


Patients were randomised ( by web-based system , in a @:@ ratio , with random permuted block design -LSB- block size @ , @ , or @ -RSB- , stratified by clinical site ) to medical management with interventional therapy ( ie , neurosurgery , embolisation , or stereotactic radiotherapy , alone or in combination ) or medical management alone ( ie , pharmacological therapy for neurological symptoms as needed ) .


Patients , clinicians , and investigators are aware of treatment assignment .


The primary outcome is time to the composite endpoint of death or symptomatic stroke ; the primary analysis is by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT@ .


Randomisation was started on April @ , @ , and was stopped on April @ , @ , when a data and safety monitoring board appointed by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health recommended halting randomisation because of superiority of the medical management group ( log-rank Z statistic of @ , exceeding the prespecified stopping boundary value of @ ) .


At this point , outcome data were available for @ patients ( mean follow-up @ months -LSB- SD @ -RSB- ) , @ assigned to interventional therapy and @ to medical management .


The primary endpoint had been reached by @ ( @ % ) patients in the medical management group compared with @ ( @ % ) in the interventional therapy group .


The risk of death or stroke was significantly lower in the medical management group than in the interventional therapy group ( hazard ratio @ , @ % CI @-@ ) .


No harms were identified , other than a higher number of strokes ( @ vs @ , p < @ ) and neurological deficits unrelated to stroke ( @ vs @ , p = @ ) in patients allocated to interventional therapy compared with medical management .


The ARUBA trial showed that medical management alone is superior to medical management with interventional therapy for the prevention of death or stroke in patients with unruptured brain arteriovenous malformations followed up for @ months .


The trial is continuing its observational phase to establish whether the disparities will persist over an additional @ years of follow-up .


Corticosteroids are frequently used in cancer pain management despite limited evidence .


This study compares the analgesic efficacy of corticosteroid therapy with placebo .


Adult patients with cancer receiving opioids with average pain intensity @ ( numeric rating scale -LSB- NRS -RSB- , @ to @ ) in the last @ hours were eligible .


Patients were randomly assigned to methylprednisolone ( MP ) @ mg twice daily or placebo ( PL ) for @ days .


Primary outcome was average pain intensity measured at day @ ( NRS , @ to @ ) ; secondary outcomes were analgesic consumption ( oral morphine equivalents ) , fatigue and appetite loss ( European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire C@ , @ to @ ) , and patient satisfaction ( NRS , @ to @ ) .


A total of @ patients were screened ; @ were randomly assigned , and @ were analyzed .


Baseline opioid level was @ mg in the MP arm and @ mg in the PL arm .


At day-@ evaluation , there was no difference between the groups in pain intensity ( MP , @ v PL , @ ; P = @ ) or relative analgesic consumption ( MP , @ v PL , @ ; P = @ ) .


Clinically and statistically significant improvements were found in fatigue ( -@ v @ points ; P @ ) , appetite loss ( -@ v @ points ; P = @ ) , and patient satisfaction ( @ v @ points ; P = @ ) in favor of the MP compared with the PL group , respectively .


There were no differences in adverse effects between the groups .


MP @ mg daily did not provide additional analgesia in patients with cancer receiving opioids , but it improved fatigue , appetite loss , and patient satisfaction .


Clinical benefit beyond a short-term effect must be examined in a future study .


To investigate the role of epoxyeicosatrienoic acids ( EETs ) and prostaglandins ( PGs ) in retinal blood vessel calibers and vasodilation during flicker light stimulation in humans .


Twelve healthy nonsmokers participated in a balanced crossover study .


Oral fluconazole @ mg and dispersible aspirin @ mg were used to inhibit production of EETs and PGs , respectively .


Retinal imaging was performed @ hour after drug ingestion with the Dynamic Vessel Analyzer .


Resting calibers of selected vessel segments were recorded in measurement units ( MU ) .


Maximum percentage dilations during flicker stimulation were calculated from baseline calibers .


We then studied six participants each after fluconazole and aspirin ingestions at @-minute intervals for @ hours .


Within-subject differences were assessed by ANOVA and Dunnett-adjusted pairwise comparisons with significance taken at P < @ .


In crossover study participants , mean ( SD ) arteriole and venule dilations without drug administration were @ % ( @ % ) and @ % ( @ % ) , respectively .


Neither drug affected vasodilation during flicker stimulation .


Mean ( SD ) resting arteriole and venule calibers on no-drug visits were @ ( @ ) MU and @ ( @ ) MU , respectively .


Fluconazole reduced mean ( @ % CI ) resting venule calibers by @ ( @ ) MU .


In repeated measures participants , neither drug affected vasodilations , but fluconazole reduced resting venule calibers over @ hours ( P < @ ) .


Epoxyeicosatrienoic acids and prostaglandins are unlikely to be primary mediators of flicker light-induced retinal vasodilation in humans .


However , EETs may play a role in the regulation of retinal vascular tone and blood flow under resting physiological conditions .


HS@ ( @ mg chitosan-loaded chewing gum ) is designed to bind salivary phosphorus as an add-on to available phosphorus binders .


We performed a randomized , placebo-controlled , double-blind study to evaluate the efficacy and safety of HS@ in hemodialysis ( HD ) patients with hyperphosphatemia as an add-on to phosphorus binders .


Sixty-eight HD patients who were maintained on calcium carbonate ( n = @ ) or sevelamer hydrochloride ( n = @ ) were enrolled .


The primary end point was a change in serum phosphorus levels .


Secondary end points included changes in levels of salivary phosphorus , serum calcium , parathyroid hormone ( PTH ) , and intact fibroblast growth factor ( iFGF ) @ .


Sixty-three patients chewed either HS@ ( n = @ ) or placebo ( n = @ ) for @ min , three times a day , for @ weeks .


HS@ was well tolerated and safe .


However , HS@ was not superior to placebo with additional reduction of serum phosphorus with respect to phosphorus binders at the end of the chewing period .


There were no significant effects of HS@ on reduction of salivary phosphorus , serum calcium , iPTH , or iFGF@ levels .


The chitosan-loaded chewing gum HS@ does not affect serum and salivary phosphorus levels in Japanese HD patients with hyperphosphatemia .


Our findings do not support previous findings that @ mg of chitosan-loaded chewing gum reduces serum and salivary phosphorus levels .


Dietary guidelines suggest limiting daily sodium intake to < @,@ mg for the general population , and < @,@ mg/d for those with certain cardiovascular risk factors .


Despite these recommendations , few Americans are able to achieve this goal .


Identifying challenges in meeting these guidelines is integral for successful compliance .


This analysis examined patterns and amount of daily sodium intake among participants with metabolic syndrome enrolled in a one-year dietary intervention study .


Two hundred forty participants with metabolic syndrome enrolled in a dietary intervention trial to lose weight and improve dietary quality .


Three @-hour dietary recalls were collected at each visit which provided meal patterns and nutrient data , including sodium intake .


A secondary data analysis was conducted to examine sodium consumption patterns at baseline and at one-year study visits .


Sodium consumption patterns over time were examined using linear mixed models .


The percentage of meals reported eaten in the home at both baseline and one-year follow-up was approximately @ % .


Follow-up for the one-year dietary intervention revealed that the participants who consumed sodium greater than @,@ mg/d declined from @ % ( at baseline ) to @ % , and those that consumed higher than @,@ mg/d declined from @ % ( at baseline ) to @ % .


Average sodium intake decreased from @,@ mg at baseline to @,@ mg at one-year ( P < @ ) , and the sodium potassium ratio also decreased from @ to @ ( P < @ ) .


Sodium intake per meal varied significantly by meal type , location , and weekday , with higher intake at dinner , in restaurants , and on weekends .


At-home lunch and dinner sodium intake decreased ( P < @ ) , while dinner sodium intake at restaurant/fast food chains increased from baseline to one-year ( P < @ ) .


Sodium intake for the majority of participants exceeded the recommended dietary guidelines .


Findings support actions that encourage low-sodium food preparation at home and encourage public health policies that decrease sodium in restaurants and prepared foods .


To investigate the clinical efficacy and safety of an additional core vitrectomy to the standard therapy in patients with exudative age-related macular degeneration ( ARMD ) .


In this prospective , controlled , single-centre study , @ eyes of @ patients ( mean age : @ @ ; median @ ( @/@ ) ) with ARMD were enrolled and randomized @:@ to group @ - core vitrectomy additional to three times injections of ranibizumab ( @x Rbz ) and Group @ - @x Rbz ( control ) .


@ @ of @ eyes in Group @ ( @ % ) and @ of @ ( @ % ) in Group @ had a posterior vitreous detachment ( PVD ) prior to start of the study .


Changes in best-corrected visual acuity ( BCVA ) using ETDRS charts , central macular thickness and macular volume ( OCT ) as well as the rate of reinjection with an OCT-based pro renata ( PRN ) protocol were monitored prospectively over @ weeks .


Forty-seven eyes completed follow-up at week @ .


In Group @ , @ of @ lost @ line of BCVA ( @ % ) and @ of @ lost @ lines ( @ % ) , whereas @ of @ gained more than @ line ( @ % ) and improved in average by @ letters .


In Group @ , @ of @ remained stable and @ of @ gained more than or exactly @ line ( @ % ) , resulting in @ letters , with no loss of lines .


Central macular thickness decreased by @ m ( @ % ) in Group @ and by @ m ( @ % ) in Group @ compared with baseline .


In Group @ , four patients received three additional and two patients , two additional Rbz injections .


In Group @ , three patients received three additional , three patients two and @ patients one additional Rbz injections .


This yielded in an average injection rate of @ in Group @ and @ in Group @ over @ weeks .


Posterior vitreous detachment ( PVD ) was identified in Group @ in @ of @ ( @ % ) and in Group @ in @ of @ ( @ % ) patients at baseline .


At week @ , @ of @ ( @ % ) of the patients in Group @ with initial attached vitreous showed a vitreal detachment , whereas only @ of @ ( @ % ) in Group @ had a new occurred detachment of the vitreous .


No systemic or ocular adverse events were noticed .


An initial core vitrectomy combined with a conventional ranibizumab injection regimen for exudative AMD patients was safe and lead to similar functional results with less intravitreal ranibizumab injections over @ weeks .


The pharmacokinetic ( PK ) similarity between PF-@ , a proposed trastuzumab biosimilar , trastuzumab sourced from European Union ( trastuzumab-EU ) or from United States ( trastuzumab-US ) was evaluated .


Safety and immunogenicity were also assessed .


In this phase @ , double-blind trial ( NCT@ ) , @ healthy male volunteers were randomized @:@:@ to receive a single @mgkg ( -@ ) intravenous dose of PF-@ , trastuzumab-EU , or trastuzumab-US , and evaluated for @ days .


Drug concentration-time data were analyzed by non-compartmental methods .


PK similarity for the comparisons of PF-@ to each of trastuzumab-EU and trastuzumab-US , and trastuzumab-EU to trastuzumab-US were determined using the standard @ % to @ % bioequivalence criteria .


Baseline demographics for the @ subjects evaluable for PK were similar across all arms .


The three products exhibited similar PK profiles with target-mediated disposition .


The @ % CIs for the ratios of Cmax , AUC ( @ , t last ) and AUC ( @ , ) were within @ % to @ % for all three pairwise comparisons .


Adverse events ( AEs ) were similar across all arms with treatment-related AEs reported by @ % , @ % and @ % subjects in the PF-@ , trastuzumab-EU , and trastuzumab-US arms , respectively .


The most common AEs were infusion-related reactions , headache , chills , pyrexia and nausea .


The AE term ` pyrexia ' was numerically greater in the PF-@ arm .


All post-dose samples , except @ , tested negative for anti-drug antibodies ( ADA ) .


This study demonstrates PK similarity among PF-@ , trastuzumab-EU and trastuzumab-US .


The safety and immunogenicity profiles observed for the three products in this study are consistent with previous reports for trastuzumab .


Dizziness is one of the most challenging symptoms in medicine .


No medication for dizziness in current use has well-established curative or prophylactic value or is suitable for long-term palliative use .


Unconventional remedies , such as acupuncture , should be considered and scientifically evaluated .


However , there has been relatively little evidence in randomized controlled clinical trials on acupuncture to treat chronic dizziness .


The aim of our study is to evaluate the efficacy and safety of acupuncture in patients with dizziness .


This trial is a randomized , single-blind , controlled study .


A total of @ participants will be randomly assigned to two treatment groups receiving acupuncture and sham acupuncture treatment , respectively , for @ weeks .


The primary outcome measures are the Dizziness Handicap Inventory ( DHI ) and the Vertigo Symptom Scale ( VSS ) .


Treatment will be conducted over a period of @ weeks , at a frequency of two sessions per week .


The assessment is at baseline ( before treatment initiation ) , @ weeks after the first acupuncture session , and @ weeks after the first acupuncture session .


The results from this study will provide clinical evidence on the efficacy and safety of acupuncture in patients with chronic dizziness .


To investigate the clinical effect of negative pressure drainage after septum surgery .


One hundred and two cases with septum deviation were randomly divided into two groups , i. e. experimental group and controlling one .


With @ cases in each .


Degree of comfort and complication of two groups were compared .


The cases in experimental group showed significantly relieved postoperative reaction with negative pressure drainage , when compared with that of controls , the incidence of complication were not increased .


Negative pressure drainage can be taken as one of the ideal materials for hemostasia after septum surgery .


To determine expression of apoptotic factors p@ and caspase-@ in human lens epithelial cells ( LECs ) of cataract patients with or without diabetic retinopathy ( DR ) , the duration of diabetes mellitus ( DM ) , and the level of glycated hemoglobin ( hemoglobin A@c -LSB- HbA@c -RSB- ) .


St. Mary 's Hospital , Catholic University of Korea , Seoul , South Korea .


Randomized prospective study .


The LECs were isolated during cataract surgery .


The isolated samples were classified into @ groups as follows : patients without DM ( Group @ ) , patients with DM but not DR ( Group @ ) , diabetic patients with nonproliferative DR ( Group @ ) , and diabetic patients with proliferative DR ( Group @ ) .


To explore the mechanism of apoptosis , the expressions of p@ and caspase-@ were measured by immunohistochemical staining and compared with the data according to the duration of DM , HbA@c levels , and severity of DR.


All groups comprised @ eyes .


The expressions of P@ and caspase-@ were higher in Groups @ , @ , and @ than in Group @ ( P < @ ) .


The expressions were statistically significantly increased with a longer duration of DM , higher HbA@c levels , and advanced DR.


The expressions of P@ and caspase-@ were strong in patients with DM and advanced DR. Knowledge of these relationships may lead to a better understanding of the development of diabetic cataract .


To evaluate the effectiveness of nonnutritive sucking ( NNS ) and oral stimulation ( OS ) , either applied alone or in combination , to reduce the transition time from tube feeding to independent oral feeding .


Randomized controlled trial .


A @-bed neonatal ICU in a university hospital in the People 's Republic of China .


A total of @ preterm infants were admitted to the neonatal ICU from December @ to July @ .


Oral motor interventions .


One hundred twelve preterm infants were assigned to three intervention groups ( NNS , OS , and combined NNS + OS ) and one control group .


Primary outcome was the number of days needed from introduction of oral feeding to autonomous oral feeding ( transition time ) .


Secondary outcome measures were the rate of milk transfer ( mL/min ) , proficiency ( intake first @ min/volume ordered ) , volume transfer ( volume transferred during entire feeding/volume prescribed ) , weight , and hospital length of stay .


Transition time was reduced in the three intervention groups compared with the control group ( p < @ ) .


The milk transfer rate in the three intervention groups was greater than in the control group ( F@ ,@ = @ ; p < @ ) .


Proficiency in the NNS and OS groups did not exceed that in the control group while the proficiency in the NNS + OS group was greater than that in the control group at the stage when the infants initiated the oral feeding ( p = @ ) .


Among all groups , no significant difference was found on weight gain and length of stay .


The combined NNS + OS intervention reduced the transition time from introduction to independent oral feeding and enhanced the milk transfer rate .


The combined intervention seems to have a beneficial effect on oral feeding proficiency in preterm infants .


Aromatase inhibitors ( AIs ) have been associated with decrements in patient-reported outcomes ( PROs ) .


The objective of this study was to assess whether real acupuncture ( RA ) , compared with sham acupuncture ( SA ) , improves PROs in patients with breast cancer who are receiving an adjuvant AI .


Postmenopausal women with a stage @ through III breast cancer who received an AI and had treatment-associated musculoskeletal symptoms were randomized to receive @ weekly RA versus SA in a dual-center , randomized controlled trial .


The National Surgical Adjuvant Breast and Bowel Project ( NSABP ) menopausal symptoms questionnaire , the Center for Epidemiological Studies Depression ( CESD ) scale , the Hospital Anxiety and Depression Scale ( HADS ) , the Pittsburgh Sleep Quality Index ( PSQI ) , the hot flash daily diary , the Hot Flash-Related Daily Interference Scale ( HFRDI ) , and the European quality-of-life survey ( EuroQol ) were used to assess PROs at baseline and at @weeks , @ weeks , and @ weeks .


The intention-to-treat analysis included @ patients in the RA arm and @ patients in the SA arm .


There were no significant differences in baseline characteristics between the @ groups .


Compared with baseline , scores in the RA arm improved significantly at week @ on the CESD ( P = @ ) , hot flash severity ( P = @ ) , hot flash frequency ( P = @ ) , the HFRDI ( P = @ ) , and NSABP menopausal symptoms ( P = @ ) ; scores in the SA arm improved significantly on the EuroQol ( P = @ ) , the HFRDI ( P = @ ) , and NSABP menopausal symptoms ( P = @ ) .


Post-hoc analysis indicated that African American patients ( n = @ ) benefited more from RA than SA compared with non-African American patients ( n = @ ) in reducing hot flash severity ( P < @ ) and frequency ( P < @ ) scores .


Both RA and SA were associated with improvement in PROs among patients with breast cancer who were receiving AIs , and no significant difference was detected between arms .


Racial differences in response to acupuncture warrant further study .


To evaluate the effect of atomoxetine treatment on executive functions in young adults with attention-deficit/hyperactivity disorder ( ADHD ) .


In this Phase @ , multi-center , double-blind , placebo-controlled trial , young adults ( @-@ years ) with ADHD were randomized to receive atomoxetine ( @-@ mg BID , N = @ ) or placebo ( N = @ ) for @ weeks .


The Behavior Rating Inventory of Executive Function-Adult ( BRIEF-A ) consists of @ self-report items within @ nonoverlapping clinical scales measuring various aspects of executive functioning .


Mean changes from baseline to @-week endpoint on the BRIEF-A were analyzed using an ANCOVA model ( terms : baseline score , treatment , and investigator ) .


At baseline , there were no significant treatment group differences in the percentage of patients with BRIEF-A composite or index T-scores @ ( p > @ ) , with over @ % of patients having composite scores @ ( @ deemed clinically meaningful for these analyses ) .


At endpoint , statistically significantly greater mean reductions were seen in the atomoxetine versus placebo group for the BRIEF-A Global Executive Composite ( GEC ) , Behavioral Regulation Index ( BRI ) , and Metacognitive Index ( MI ) scores , as well as the Inhibit , Self-Monitor , Working Memory , Plan/Organize and Task Monitor subscale scores ( p < @ ) , with decreases in scores signifying improvements in executive functioning .


Changes in the BRIEF-A Initiate ( p = @ ) , Organization of Materials ( p = @ ) , Shift ( p = @ ) , and Emotional Control ( p = @ ) subscale scores were not statistically significant .


In addition , the validity scales : Inconsistency ( p = @ ) , Infrequency ( p = @ ) , and Negativity ( p = @ ) were not statistically significant , showing scale validity .


Statistically significantly greater improvement in executive function was observed in young adults with ADHD in the atomoxetine versus placebo group as measured by changes in the BRIEF-A scales .


In the general population , the epidemiological relationships between delirium and adverse outcomes are not well defined .


The aims of this study were to : ( @ ) construct an algorithm for the diagnosis of delirium using the Geriatric Mental State ( GMS ) examination ; ( @ ) test the criterion validity of this algorithm against mortality and dementia risk ; ( @ ) report the age-specific prevalence of delirium as determined by this algorithm .


Participant and informant data in a randomly weighted subsample of the Cognitive Function and Ageing Study were taken from a standardized assessment battery .


The algorithmic definition of delirium was based on the DSM-IV classification .


Outcomes were : proportional hazard ratios for death ; odds ratios of dementia at @-year follow-up .


Data from @ persons ( representative of @,@ ) were used , median age @ years , @ % women .


Study-defined delirium was associated with a new dementia diagnosis at two years ( OR @ , @ % CI @ to @ ) and death ( HR @ , @ % CI @ to @ ) , even after adjustment for acute illness severity .


Similar associations were seen for study-defined subsyndromal delirium .


Age-specific prevalence as determined by the algorithm increased with age from @ % in the @-@ year age group to @ % in the @ age group ( p < @ for trend ) .


For study-defined subsyndromal delirium , age-specific period prevalence ranged from @ % ( @-@ years ) to @ % ( @ years ) .


These results demonstrate the possibility of constructing an algorithmic diagnosis for study-defined delirium using data from the GMS schedule , with predictive criterion validity for mortality and dementia risk .


These are the first population-based analyses able to account prospectively for both illness severity and an earlier study diagnosis of dementia .


Secondary progressive multiple sclerosis , for which no satisfactory treatment presently exists , accounts for most of the disability in patients with multiple sclerosis .


Simvastatin , which is widely used for treatment of vascular disease , with its excellent safety profile , has immunomodulatory and neuroprotective properties that could make it an appealing candidate drug for patients with secondary progressive multiple sclerosis .


We undertook a double-blind , controlled trial between Jan @ , @ , and Nov @ , @ , at three neuroscience centres in the UK .


Patients aged @-@ years with secondary progressive multiple sclerosis were randomly assigned ( @:@ ) , by a centralised web-based service with a block size of eight , to receive either @ mg of simvastatin or placebo .


Patients , treating physicians , and outcome assessors were masked to treatment allocation .


The primary outcome was the annualised rate of whole-brain atrophy measured from serial volumetric MRI .


Analyses were by intention to treat and per protocol .


This trial is registered with ClinicalTrials.gov , number NCT@ .


@ participants were randomly assigned to receive either simvastatin ( n = @ ) or placebo ( n = @ ) .


The mean annualised atrophy rate was significantly lower in patients in the simvastatin group ( @ % per year -LSB- SD @ -RSB- ) than in those in the placebo group ( @ % per year -LSB- @ -RSB- ) .


The adjusted difference in atrophy rate between groups was -@ % per year ( @ % CI -@ to -@ ; p = @ ) ; a @ % reduction in annualised rate .


Simvastatin was well tolerated , with no differences between the placebo and simvastatin groups in proportions of participants who had serious adverse events ( @ -LSB- @ % -RSB- vs nine -LSB- @ % -RSB- ) .


High-dose simvastatin reduced the annualised rate of whole-brain atrophy compared with placebo , and was well tolerated and safe .


These results support the advancement of this treatment to phase @ testing .


Housing First has become a popular treatment model for homeless adults with mental illness , yet little is known about program participants ' early experiences or trajectories .


This study used a mixed methods design to examine participant changes in selected domains @ months after enrollment in a Canadian field trial of Housing First .


The study sample included @ participants receiving the Housing First intervention at the Toronto site of the At Home/Chez Soi project .


This study used a pre-post design to compare quantitative @-month outcome data to baseline values in key domains and multivariate regression to identify baseline demographic , clinical or service use variables associated with observed changes in these domains .


In addition , qualitative data exploring participant and service provider perspectives and experiences was collected via stakeholder interviews and focus groups , and analyzed using thematic analysis .


The majority ( @ to @ % ) of participants followed the expected trajectory of improvement , with the remaining experiencing difficulties in community integration , mental health symptom severity , substance use , community functioning and quality of life @ months after program enrollment .


Diagnosis of psychotic disorder was associated with a reduction in quality of life from baseline to @-months , while substance use disorders were associated with reduced mental illness symptoms and substance use related problems and an improvement in quality of life .


Participants housed in independent housing at @-months had greater improvements in community integration and quality of life , and greater reduction in mental illness symptoms , compared to those not independently housed .


The quality of the working alliance was positively associated with improvements in physical and psychological community integration and quality of life .


Qualitative data provided a unique window into the loneliness and isolation experienced by Housing First participants , as well as problems related to substance use and a need for life skills training and support .


Additional strategies can help support Housing First participants in the early stages of program participation and address potential causes of early difficulties , including lack of life skills and social isolation .


This study highlights the importance of early and ongoing evaluation , monitoring and program adaptations to address consumer support needs .


In the UK around @ % of men and @ % of women are obese , and there are varying but worrying levels in other European countries .


Obesity is a chronic condition that carries an important health risk .


National guidelines , for use in England , on the management of people who are overweight or obese have been published by the National Institute for Health and Clinical Excellence ( NICE , @ ) .


NICE recommendations for primary care teams are : determine the degree of overweight and obesity ; assess lifestyle , comorbidities and willingness to change ; offer multicomponent management of overweight and obesity ; referral to external services when appropriate .


This study investigates a tailored intervention to improve the implementation of these recommendations by primary care teams .


The study is a cluster randomised controlled trial .


Primary care teams will be recruited from the East Midlands of England , and randomised into two study arms : @ ) the study group , in which primary care teams are offered a set of tailored interventions to help implement the NICE guidelines for overweight and obesity ; or @ ) the control group in which primary care teams continue to practice usual care .


The primary outcome is the proportion of overweight or obese patients for whom the primary care team adheres to the NICE guidelines .


Secondary outcomes include the proportion of patients with a record of lifestyle assessment , referral to external weight loss services , the proportion of obese patients who lose weight during the intervention period , and the mean weight change over the same period .


Although often recommended , the methods of tailoring implementation interventions to account for the determinants of practice are not well developed .


This study is part of a programme of studies seeking to develop the methods of tailored implementation .


A multicenter , randomized phase II trial , RECORD-@ , was conducted to compare first-line everolimus followed by sunitinib at progression with the standard sequence of first-line sunitinib followed by everolimus in patients with metastatic renal cell carcinoma .


RECORD-@ used a crossover treatment design .


The primary objective was to assess progression-free survival ( PFS ) noninferiority of first-line everolimus compared with first-line sunitinib .


Secondary end points included combined PFS for each sequence , overall survival ( OS ) , and safety .


Of @ enrolled patients , @ were randomly assigned to first-line everolimus followed by sunitinib , and @ were randomly assigned to first-line sunitinib followed by everolimus .


The primary end point was not met ; the median PFS was @ months for first-line everolimus and @ months for first-line sunitinib ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ) .


Among patients who discontinued first-line , @ ( @ % ) crossed over from everolimus to second-line sunitinib , and @ ( @ % ) crossed over from sunitinib to second-line everolimus .


The median combined PFS was @ months for sequential everolimus then sunitinib and was @ months for sequential sunitinib then everolimus ( HR , @ ; @ % CI , @ to @ ) .


The median OS was @ months for sequential everolimus and then sunitinib and @ months for sequential sunitinib and then everolimus ( HR , @ ; @ % CI , @ to @ ) .


Common treatment-emergent adverse events during first-line everolimus or sunitinib were stomatitis ( @ % and @ % , respectively ) , fatigue ( @ % and @ % , respectively ) , and diarrhea ( @ % and @ % , respectively ) .


Everolimus did not demonstrate noninferiority compared with sunitinib as a first-line therapy .


The trial results support the standard treatment paradigm of first-line sunitinib followed by everolimus at progression .


To report the refractive , topographic , and clinical outcomes @ years after corneal collagen cross-linking ( CXL ) in eyes with progressive keratoconus .


Prospective , randomized controlled trial .


One hundred eyes with progressive keratoconus were randomized into the CXL treatment or control groups .


Cross-linking was performed by instilling riboflavin @ % solution containing @ % dextran for @ minutes before and during the @ minutes of ultraviolet A irradiation ( @ mW/cm ( @ ) ) .


Follow-up examinations were arranged at @ , @ , @ , @ , and @ months .


The primary outcome measure was the maximum simulated keratometry value ( Kmax ) .


Other outcome measures were uncorrected visual acuity ( UCVA ; measured in logarithm of the minimum angle of resolution -LSB- logMAR -RSB- units ) , best spectacle-corrected visual acuity ( BSCVA ; measured in logMAR units ) , sphere and cylinder on subjective refraction , spherical equivalent , minimum simulated keratometry value , corneal thickness at the thinnest point , endothelial cell density , and intraocular pressure .


The results from @ control and @ treated eyes are reported .


In control eyes , Kmax increased by a mean of @ diopters ( D ) , @ D , and @ D at @ , @ , and @ months , respectively ( all P < @ ) .


In treated eyes , Kmax flattened by-@ @ D,-@ @ D , and-@ @ D at @ , @ , and @ months , respectively ( all P < @ ) .


The mean change in UCVA in the control group was +@ logMAR ( P = @ ) at @ months .


In the treatment group , both UCVA ( -@ logMAR ; P = @ ) and BSCVA ( -@ logMAR ; P = @ ) improved at @ months .


There was a significant reduction in corneal thickness measured using computerized videokeratography in both groups at @ months ( control group : -@ m , P < @ ; treatment group : -@ m , P < @ ) that was not observed in the treatment group using the manual pachymeter ( treatment group : +@ m , P = @ ) .


The manifest cylinder increased by @ D ( P = @ ) in the control group at @ months .


There were @ eyes with minor complications that did not affect the final visual acuity .


At @ months , there was a sustained improvement in Kmax , UCVA , and BSCVA after CXL , whereas eyes in the control group demonstrated further progression .


Ready-to-use therapeutic food ( RUTF ) has been found effective in treating severe acute malnutrition .


Vietnam 's National Institute of Nutrition ( NIN ) , the Institut de Recherche pour le Dveloppement ( IRD ) , and UNICEF collaborated to formulate a local RUTF called High-Energy Bar for Integrated Management of Acute Malnutrition ( HEBI ) .


RUTF might be useful to address malnutrition in HIV patients .


To compare the acceptability of the local RUTF and an imported RUTF among malnourished people with HIV in Vietnam Methods : The acceptability of HEBI and Plumpy'Nut was studied among @ HIV-positive children and @ HIV-positive adults .


In a crossover design , participants were randomly assigned to receive either Plumpy'Nut or HEBI for @ weeks and were switched to the other product for the subsequent @ weeks .


A third ( control ) group of about @ HIV-positive participants in each study was randomly assigned to receive no RUTF .


Nurses took anthropometric measurements weekly , and the subjects or their caregivers monitored daily RUTF intake .


Children consumed @ % of HEBI and @ % of Plumpy'Nut ( p = @ ) .


Adults consumed @ % of HEBI and @ % of Plumpy'Nut ( p = @ ) .


Both children ( p = @ ) and adults ( p @ ) preferred HEBI .


Significant gains were observed in percent weight ( p = @ ) , weight-for-age ( p = @ ) , and body mass index ( BMI ) - for-age ( p = @ ) in children who received RUTF and in percent weight ( p = @ ) and BMI ( p = @ ) in adults who received RUTF compared with the control groups .


In this study in Vietnam , both HEBI and Plumpy'Nut were found acceptable by people with HIV .


High-sensitivity cardiac troponin I ( cTnI ) assays hold promise in detecting the transition from hypertrophy to heart failure in aortic stenosis .


We sought to investigate the mechanism for troponin release in patients with aortic stenosis and whether plasma cTnI concentrations are associated with long-term outcome .


Plasma cTnI concentrations were measured in two patient cohorts using a high-sensitivity assay .


First , in the Mechanism Cohort , @ patients with aortic stenosis ( median age @ , @ % male , aortic valve area @ @ cm ( @ ) ) underwent cardiovascular magnetic resonance and echocardiography to assess left ventricular ( LV ) myocardial mass , function , and fibrosis .


The indexed LV mass and measures of replacement fibrosis ( late gadolinium enhancement ) were associated with cTnI concentrations independent of age , sex , coronary artery disease , aortic stenosis severity , and diastolic function .


In the separate Outcome Cohort , @ patients originally recruited into the Scottish Aortic Stenosis and Lipid Lowering Trial , Impact of REgression ( SALTIRE ) study , had long-term follow-up for the occurrence of aortic valve replacement ( AVR ) and cardiovascular deaths .


Over a median follow-up of @ years ( @ patient-years ) , @ patients died from a cardiovascular cause and @ patients had an AVR .


Plasma cTnI concentrations were associated with AVR or cardiovascular death HR @ ( @ % CI , @ to @ ) independent of age , sex , systolic ejection fraction , and aortic stenosis severity .


In patients with aortic stenosis , plasma cTnI concentration is associated with advanced hypertrophy and replacement myocardial fibrosis as well as AVR or cardiovascular death .


The combination of seawater baths and narrowband ultraviolet B ( NB-UVB ) is a known treatment for psoriasis .


This study evaluates two treatment regimens that combine bathing in geothermal seawater and NB-UVB therapy in comparison with NB-UVB monotherapy .


Sixty-eight psoriasis patients were randomly assigned to outpatient bathing in geothermal seawater combined with NB-UVB therapy three times a week , intensive daily treatment involving bathing in geothermal seawater combined with NB-UVB therapy , or NB-UVB therapy alone three times a week ; treatment period was @ weeks .


Disease severity -LSB- Psoriasis Area Severity Index ( PASI ) and Lattice System Physician 's Global Assessment scores -RSB- , quality of life ( Dermatology Life Quality Index ) and histological changes were evaluated before , during and after treatment .


The primary end point was the proportion of patients who achieved PASI @ at @ weeks .


At @ weeks , the percentage of patients who achieved PASI @ and PASI @ was significantly greater for both regimens , bathing in geothermal seawater three times a week ( @ % and @ % , respectively ) and intensive treatment with geothermal seawater ( @ % and @ % , respectively ) than for NB-UVB monotherapy ( @ % and @ % , respectively ) ( P < @ in all comparisons ) .


Clinical improvement was paralleled by improvement in quality of life and histological score and a reduction in NB-UVB doses .


Bathing in geothermal seawater combined with NB-UVB therapy in psoriasis induces faster clinical and histological improvement , produces longer remission time and permits lower NB-UVB doses than UVB therapy alone .


n-@ polyunsaturated fatty acids ( contained in fish oil ) have been shown to beneficially influence infection rate and clinical outcomes in surgical patients probably due to their immunomodulatory action .


In contrast , study results of fish oil administration in critically ill patients are controversial .


The aim of this study was to investigate the effects of n-@ polyunsaturated fatty acids on the prevalence of nosocomial infections and clinical outcomes in medical and surgical critically ill patients .


Prospective , multicenter , randomized , comparative , double-blind study .


Seventeen Spanish ICUs during @ years .


A total of @ medical and surgical intensive care patients with Acute Physiology and Chronic Health Evaluation II score more than or equal to @ , expected to require total parenteral nutrition for at least @ days .


Patients received total parenteral nutrition prepared either with a lipid emulsion containing @ % fish oil or a fish oil-free lipid emulsion .


The prevalence of nosocomial infections was detected during @ days of ICU stay .


Patients were followed @ months after discharge from the ICU for length of hospital stay , hospital mortality , and @-month mortality .


The number of patients with nosocomial infections was significantly reduced in the fish oil-receiving group ( @ % vs @ % , p = @ ) and the predicted time free of infection was prolonged ( @ @ vs @ @ d , p = @ ) .


No significant differences were detected for ICU , hospital , and @-month mortality .


The results show that administration of n-@ polyunsaturated fatty acids reduces the risk of nosocomial infections and increases the predicted time free of infections in critically ill medical and surgical patients .


The administration of n-@ polyunsaturated fatty acids was safe and well tolerated .


The recent withdrawal of a targeted sepsis therapy has diminished pharmaceutical enthusiasm for developing novel drugs for the treatment of sepsis .


Angiopoietin-@ is an endothelial-derived protein that potentiates vascular inflammation and leakage and may be involved in sepsis pathogenesis .


We screened approved compounds for putative inhibitors of angiopoietin-@ production and investigated underlying molecular mechanisms .


Laboratory and animal research plus prospective placebo-controlled randomized controlled trial ( NCT@ ) and retrospective analysis ( NCT@ ) .


Research laboratories of Hannover Medical School and Harvard Medical School .


Septic patients/C@Bl/@ mice and human endothelial cells .


Food and Drug Administration-approved library screening .


In a cell-based screen of more than @ Food and Drug Administration-approved compounds , we identified multiple members of the @-hydroxy-@-methyl-glutaryl-CoA reductase inhibitor drug class ( referred to as statins ) that suppressed angiopoietin-@ .


Simvastatin inhibited @-hydroxy-@-methyl-glutaryl-CoA reductase , which in turn activated PI@K-kinase .


Downstream of this signaling , PI@K-dependent phosphorylation of the transcription factor Foxo@ at key amino acids inhibited its ability to shuttle to the nucleus and bind cis-elements in the angiopoietin-@ promoter .


In septic mice , transient inhibition of angiopoietin-@ expression by liposomal siRNA in vivo improved absolute survival by @ % .


Simvastatin had a similar effect , but the combination of angiopoietin-@ siRNA and simvastatin showed no additive benefit .


To verify the link between statins and angiopoietin-@ in humans , we performed a pilot matched case-control study and a small randomized placebo-controlled trial demonstrating beneficial effects on angiopoietin-@ .


@-hydroxy-@-methyl-glutaryl-CoA reductase inhibitors may operate through a novel Foxo@-angiopoietin-@ mechanism to suppress de novo production of angiopoietin-@ and thereby ameliorate manifestations of sepsis .


Given angiopoietin-@ 's dual role as a biomarker and candidate disease mediator , early serum angiopoietin-@ measurement may serve as a stratification tool for future trials of drugs targeting vascular leakage .


To evaluate the efficacy and safety of alogliptin added to insulin in Japanese patients with type @ diabetes mellitus ( T@DM ) who are poorly controlled with insulin and diet or exercise .


This was a randomized , double-blind , @-week comparative trial of alogliptin and insulin versus placebo and insulin in @ patients with T@DM followed by a @-week , open-label phase in @ patients on alogliptin and insulin .


Change in glycated hemoglobin ( HbA@c ) from baseline to the end of double-blind phase ( week @ ) .


The change in HbA@c ( least squares means ) from baseline to week @ was -@ % for the alogliptin and insulin group and -@ % for the placebo and insulin group .


The point estimate ( @ % confidence interval ) intergroup difference was -@ % ( -LSB- -@ % , -@ % -RSB- ) .


In the alogliptin and insulin group , HbA@c started to decrease from week @ onward and peaked by week @ .


The proportions of patients who achieved HbA@c < @ , < @ and < @ % at week @ were significantly higher in alogliptin and insulin group ( @ , @ and @ % ) than in placebo and insulin group ( @ , @ and @ % ) .


Incidences of adverse effects were comparable between groups , with no relevant increases in hypoglycemia or weight gain seen .


Alogliptin @ mg/day was effective and well tolerated when added to insulin in Japanese patients with inadequately controlled T@DM .


Fifty percent of pregnancies in the United States are unintended despite numerous contraceptive methods available to women .


The only male contraceptive methods , vasectomy and condoms , are used by @ % and @ % of couples , respectively .


Prior studies have shown efficacy of male hormonal contraceptives in development , but few have evaluated patient acceptability and potential use if commercially available .


The objective of this study is to determine if a transdermal gel-based male hormonal contraceptive regimen , containing testosterone and Nestorone gels , would be acceptable to study participants as a primary contraceptive method .


As part of a three-arm , @-month , double-blind , randomized controlled trial of testosterone and nestorone gels at two academic medical centers , subjects completed a questionnaire to assess the acceptability of the regimen .


Of the @ men randomized , @ provided data for analysis .


Overall , @ % ( @/@ ) of men were satisfied or extremely satisfied with this gel-based method of contraception , and @ % ( @/@ ) reported that they would recommend this method to others .


One third of subjects ( @/@ ) reported that they would use this as their primary method of contraception if it were commercially available today .


However , men with concerns about sexually transmitted disease were significantly less satisfied than men without such concerns ( p = @ ) .


A majority of the men who volunteered to participate in this trial of an experimental male hormonal contraceptive were satisfied with this transdermal male hormonal contraceptive .


If commercially available , a combination of topical nesterone and testosterone gels could provide a reversible , effective method of contraception that is appealing to men .


A substantial portion of men report they would use this transdermal male contraceptive regimen if commercially available .


This method would provide a novel , reversible method of contraception for men , whose current choices are limited to condoms and vasectomy .


The current study aimed to investigate the effects of eicosapentaenoic acid ( EPA ) - rich and docosahexaenoic acid ( DHA ) - rich supplementations on cognitive performance and functional brain activation .


A double-blind , counterbalanced , crossover design , with a @-day washout period between two supplementation periods ( EPA-rich and DHA-rich ) was employed .


Functional magnetic resonance imaging scans were obtained during performance of Stroop and Spatial Working Memory tasks prior to supplementation and after each @-day supplementation period .


Both supplementations resulted in reduced ratio of arachidonic acid to EPA levels .


Following the EPA-rich supplementation , there was a reduction in functional activation in the left anterior cingulate cortex and an increase in activation in the right precentral gyrus coupled with a reduction in reaction times on the colour-word Stroop task .


By contrast , the DHA-rich supplementation led to a significant increase in functional activation in the right precentral gyrus during the Stroop and Spatial Working Memory tasks , but there was no change in behavioural performance .


By extending the theory of neural efficiency to the within-subject neurocognitive effects of supplementation , we concluded that following the EPA-rich supplementation , participants ' brains worked ` less hard ' and achieved a better cognitive performance than prior to supplementation .


Conversely , the increase in functional activation and lack of improvement in time or accuracy of cognitive performance following DHA-rich supplementation may indicate that DHA-rich supplementation is less effective than EPA-rich supplementation in enhancing neurocognitive functioning after a @-day supplementation period in the same group of individuals .


The occurrence of response shift ( RS ) in longitudinal health-related quality of life ( HRQoL ) studies , reflecting patient adaptation to disease , has already been demonstrated .


Several methods have been developed to detect the three different types of response shift ( RS ) , i.e. recalibration RS , @ ) reprioritization RS , and @ ) reconceptualization RS .


We investigated two complementary methods that characterize the occurrence of RS : factor analysis , comprising Principal Component Analysis ( PCA ) and Multiple Correspondence Analysis ( MCA ) , and a method of Item Response Theory ( IRT ) .


Breast cancer patients ( n = @ ) completed the EORTC QLQ-C@ and EORTC QLQ-BR@ questionnaires at baseline , immediately following surgery , and three and six months after surgery , according to the `` then-test/post-test '' design .


Recalibration was explored using MCA and a model of IRT , called the Linear Logistic Model with Relaxed Assumptions ( LLRA ) using the then-test method .


Principal Component Analysis ( PCA ) was used to explore reconceptualization and reprioritization .


MCA highlighted the main profiles of recalibration : patients with high HRQoL level report a slightly worse HRQoL level retrospectively and vice versa .


The LLRA model indicated a downward or upward recalibration for each dimension .


At six months , the recalibration effect was statistically significant for @/@ dimensions of the QLQ-C@ and BR@ according to the LLRA model ( p @ ) .


Regarding the QLQ-C@ , PCA indicated a reprioritization of symptom scales and reconceptualization via an increased correlation between functional scales .


Our findings demonstrate the usefulness of these analyses in characterizing the occurrence of RS .


MCA and IRT model had convergent results with then-test method to characterize recalibration component of RS .


PCA is an indirect method in investigating the reprioritization and reconceptualization components of RS .


Multidose steroid pretreatment is effective in preventing postextubation airway obstruction ( PEAO ) in adults , however controversy continues for children .


This study was designed as a randomized , placebo-controlled , double-blind trial to compare the effect of @-h pretreatment with dexamethasone ( @hPD ) versus @-h pretreatment ( @hPD ) on PEAO and reintubation in children at a tertiary care hospital in a developing economy .


Hundred twenty-four children ( @ months to @ years ) intubated for @ h and planned to have extubation during next @ h were randomized to receive @hPD ( @ mg/kg/dose , q@h , total of six doses ; n = @ ) or @hPD ( total of three doses ; n = @ ) .


Patients with preexistent upper airway conditions , chronic respiratory diseases , steroid therapy in last @ days , gastrointestinal bleeding , hypertension , and hyperglycemia and those likely to have poor airway reflexes were excluded .


The two groups were similar at baseline .


@hPD reduced the incidence of PEAO ( @/@ versus @/@ ; p = @ ) with absolute risk reduction of @ % .


It also reduced the incidence of reintubation , though nonsignificantly , by half -LSB- @/@ versus @/@ ; relative risk ( RR ) , @ ; @ % confidence interval ( CI ) , @-@ @ -RSB- .


Time to recovery from PEAO among non-reintubated patients was shorter among @hPD patients ( p = @ ) .


No adverse event was noted with dexamethasone use .


Intubation duration > @ days and cuffed tracheal tubes were found to be independent risk factors for PEAO ( odds ratio @ and @ , respectively ) .


@-h pretreatment with multidose dexamethasone reduced the incidence of PEAO and the time to recover from it .


@hPD should be considered for high-risk children intubated for > @ h in the study setting .


Further studies with larger sample size from different socioeconomic background are desirable to validate these findings .


Apolipoprotein C-III ( APOC@ ) is a key regulator of plasma triglyceride levels .


Elevated triglyceride levels are associated with a risk of adverse cardiovascular events and pancreatitis .


ISIS @ is a second-generation antisense inhibitor of APOC@ synthesis .


We conducted a randomized , double-blind , placebo-controlled , dose-ranging , phase @ study to evaluate ISIS @ in untreated patients with fasting triglyceride levels between @ mg per deciliter ( @ mmol per liter ) and @ mg per deciliter ( @ mmol per liter ) ( ISIS @ monotherapy cohort ) , as well as in patients receiving stable fibrate therapy who had fasting triglyceride levels between @ mg per deciliter ( @ mmol per liter ) and @ mg per deciliter ( ISIS @-fibrate cohort ) .


Eligible patients were randomly assigned to receive either ISIS @ , at doses ranging from @ to @ mg , or placebo , once weekly for @ weeks .


The primary outcome was the percentage change in APOC@ level from baseline .


A total of @ patients were treated in the ISIS @ monotherapy cohort ( @ received active agent , and @ received placebo ) , and @ patients were treated in the ISIS @-fibrate cohort ( @ received active agent , and @ received placebo ) .


The mean ( SD ) baseline triglyceride levels in the two cohorts were @ mg per deciliter ( @ mmol per liter ) and @ mg per deciliter ( @ mmol per liter ) , respectively .


Treatment with ISIS @ resulted in dose-dependent and prolonged decreases in plasma APOC@ levels when the drug was administered as a single agent ( decreases of @ % in the @-mg group , @ % in the @-mg group , and @ % in the @-mg group , vs. an increase of @ % in the placebo group ) and when it was administered as an add-on to fibrates ( decreases of @ % in the @-mg group and @ % in the @-mg group , vs. a decrease of @ % in the placebo group ) .


Concordant reductions of @ to @ % were observed in triglyceride levels .


No safety concerns were identified in this short-term study .


We found that treatment with ISIS @ was associated with significant lowering of triglyceride levels , among patients with a broad range of baseline levels , through selective antisense inhibition of APOC@ synthesis .


( Funded by Isis Pharmaceuticals ; ClinicalTrials.gov number , NCT@ . )


Intravitreal triamcinolone acetonide ( IVTA ) is an effective treatment for recalcitrant diabetic macular oedema ( DMO ) .


It has been shown to improve vision with benefits persisting up to five years .


The most common initial side effect of IVTA treatment is rise in intraocular pressure , occurring in approximately @ % of patients within the first @ months of treatment .


We evaluated whether there is a correlation between the development of intraocular pressure rise and improvement in vision .


Analysis of individual data from @ eyes of @ participants treated with IVTA for DMO from a prospective , randomised , double-masked , placebo controlled trial .


The degree of intraocular pressure ( IOP ) rise was correlated with improvement in best-corrected visual acuity ( BCVA ) at @ and @ months .


The proportion of eyes gaining @ or more logMAR letters was higher in eyes with greater IOP rise ( p = @ ) .


Better absolute improvement in BCVA at @ months ( p = @ ) was also found in eyes with greater IOP rise .


Regression analyses revealed a correlation between IOP rise of @ or more mmHg and absolute BCVA improvement at @ months ( odds ratio @ , @ % confidence interval @-@ @ , p = @ ) , but not at @ month .


IOP rise and vision improvement appear to be correlated following IVTA for DMO , suggesting that the mechanisms that cause both may be linked .


During continuous venovenous haemofiltration ( CVVH ) , regional anticoagulation with citrate may be superior to heparin in terms of biocompatibility , since heparin as opposed to citrate may activate complement ( reflected by circulating C@a ) and induce neutrophil degranulation in the filter and myeloperoxidase ( MPO ) release from endothelium .


No anticoagulation ( n = @ ) , unfractionated heparin ( n = @ ) and trisodium citrate ( n = @ ) regimens during CVVH were compared .


Blood samples were collected pre - and postfilter ; C@a , elastase and MPO were determined by ELISA .


Additionally , C@a was also measured in the ultrafiltrate .


In the heparin group , there was C@a production across the filter which most decreased over time as compared to other groups ( P = @ ) .


There was also net production of elastase and MPO across the filter during heparin anticoagulation ( P = @ or lower ) , while production was minimal and absent in the no anticoagulation and citrate group , respectively .


During heparin anticoagulation , plasma concentrations of MPO at the inlet increased in the first @ minutes of CVVH ( P = @ ) .