We randomly allocated @ women with recent gestational diabetes mellitus to either a Web-based lifestyle program ( Balance after Baby ) delivered over the first postpartum year or to a control group .


Primary outcomes were change in body weight at @ months from @ ) first postpartum measured weight ; and @ ) self-reported prepregnancy weight .


There were no significant differences in baseline characteristics between groups including age , body mass index , race , and income status .


Women assigned to the Balance after Baby program ( n = @ , three lost to follow-up ) lost a mean of @ kg ( @ % confidence interval -@ to -@ ) from @ weeks to @ months postpartum , whereas the control group ( n = @ , one lost to follow-up ) gained a mean of @ kg ( -@ to +@ ) ( P = @ ) .


Women in the intervention were closer to prepregnancy weight at @ months postpartum ( mean change -@ kg ; -@ to +@ ) compared with women in the control arm ( +@ kg ; +@ to +@ ) ( P = @ ) .


A Web-based lifestyle modification program for women with recent gestational diabetes mellitus decreased postpartum weight retention .


To observe differences of therapeutic effects among acupuncture bloodletting , penicillin and acupuncture bloodletting combined with penicillin for children acute tonsillitis and providea better treatment method in cli nic .


Seventy-five mild cases were selected into section of mild symptoms while seventy-five severe cases were selected into section of severe symptoms .


Cases in the two sections then were divided into , an acupuncture bloodletting group , a penicillin group and a comprehensive group by random digital table method separately , @ cases in each one .


Qu-chi ( LI @ ) , Hegu ( LI @ ) , Dazhui ( GV @ ) , Shaoshang ( LU @ ) and Erjian ( EX @ ) were selected in the acupuncture bloodletting group , intravenous injection of penicillin sodium was applied in the penicillin group and acupuncture bloodletting combined with penicillin was applied in the comprehensive group .


Efficacy assessment was conducted after @ days in the section of mild symptoms and after @ days in the section of severe symptoms .


For the section of mild symptoms , the total effective rate was @ % ( @/@ ) in the comprehensive group and @ % ( @/@ ) in the acupuncture bloodletting group , which were both superior to @ % ( @/@ ) in the penicillin group ( P < @ ) , but no statistical significance was seen between the comprehensive group and acupuncture bloodletting group ( P > @ ) .


For the section of severe symptoms , the total effective rate was @ % ( @/@ ) in the comprehensive group , which was obviously superior to @ % ( @/@ ) in the acupuncture bloodletting group ( P < @ ) and @ % ( @/@ ) in the penicillin group ( P < @ ) , and no statistical significance was seen between the acupuncture bloodletting group and penicillin group ( P > @ ) .


The efficacy of acupuncture bloodletting combined with penicillin is little different from that of acupuncture bloodletting for treatment of children acute tonsillitis with mild accompanied symptoms , which were both superior to intravenous injection of penicillin sodium .


For severe accompanied symptoms , the efficacy of acupuncture bloodletting combined with penicillin is obviously superior to acupuncture bloodletting and penicillin .


To evaluate the effects of sex and menopausal status on acute - , continuation - , and maintenance-phase treatment outcomes in patients with recurrent major depressive disorder ( MDD ) .


This was a secondary analysis of data from the Prevention of Recurrent Episodes of Depression With Venlafaxine for Two Years ( PREVENT ) trial , a multiphase , multicenter , double-blind study in which adult outpatients with recurrent MDD ( by DSM-IV criteria ) were randomly assigned to @ weeks of acute-phase venlafaxine extended release ( ER ) ( @-@ mg/d ) or fluoxetine ( @-@ mg/d ) .


Patients achieving response or remission had @ months of continuation-phase treatment .


Responding or remitting patients in the venlafaxine ER group were randomly assigned to venlafaxine ER or placebo for @ consecutive @-month maintenance phases ; fluoxetine-treated patients continued receiving fluoxetine .


The outcome measures for this analysis were acute - and continuation-phase response and remission rates ( as measured by the @-item Hamilton Depression Rating Scale ) and time to depression recurrence in the maintenance phases according to sex and menopausal status at baseline .


The intent-to-treat population comprised @ patients in the venlafaxine ER group ( @ % women ) and @ patients in the fluoxetine group ( @ % women ) ; @ % of all women were premenopausal , and @ % were postmenopausal ( @ % perimenopausal ; not analyzed ) .


At acute-phase end , remission rates in the venlafaxine ER vs fluoxetine groups were @ % vs @ % in men , @ % vs @ % in women , @ % vs @ % in premenopausal women , and @ % vs @ % in postmenopausal women .


At continuation-phase end , remission rates in the venlafaxine ER vs fluoxetine groups were @ % vs @ % in men , @ % vs @ % in women , @ % vs @ % in premenopausal women and @ % vs @ % in postmenopausal women .


Response rates were consistent with these findings .


Based on a Cox proportional hazards model , sex was not a significant predictor of recurrence during the first or second maintenance phase ( hazard ratio -LSB- HR -RSB- = @ ; P = @ and HR = @ ; P = @ , respectively ) , and neither was menopausal status at acute-phase baseline ( HR = @ ; P = @ and HR = @ ; P = @ , respectively ) .


In this study of patients with recurrent MDD , treatment outcomes with venlafaxine ER and fluoxetine did not differ on the basis of sex or menopausal status .


Our confidence in these findings is limited by the lack of a placebo arm during the acute and continuation phases and by the small sample sizes for subgroup analyses in the maintenance phases .


To assess the design and the Mainland China subgroup baseline characteristics of the study to evaluate the efficacy and safety of alogliptin versus placebo in subjects with type @ diabetes ( T@DM ) as monotherapy , add-on to metformin or add-on to pioglitazone .


This was a multi-center , randomized , double-blind , placebo-controlled , @-week study comparing alogliptin ( ALO , @ mg , @/d ) versus placebo ( PLA ) as monotherapy ( A ) , add-on to metformin ( B ) or add-on to pioglitazone metformin ( C ) .


The T@DM subjects with glycosylated hemoglobin A@c ( HbA@c ) between @ % and @ % and aged between @ years and @ years were enrolled and randomized to the alogliptin group and the placebo group in @ : @ ratio with @ weeks treatment .


All patients were followed up every @ weeks .


The safety endpoints consisted of the incidence of hypoglycemia and other adverse events .


A total of @ patients were enrolled in the Mainland China subgroup of the study ( @ in group A , @ in group B and @ in group C ) .


In each treatment group , the baseline characteristics including age , gender , body mass index , diabetes duration , HbA@c , fasting plasma glucose , body weight , daily dosage of metformin and daily dosage of pioglitazone were all well balanced .


The demographic data , medical history , glycemic profile and treatment regimen at baseline in Mainland China subgroup are well balanced .


The result of this study will provide the clinical evidence for the use of alogliptin in Chinese T@DM patients .


Behavioral activation ( BA ) is an empirically validated treatment that reduces depression by increasing overt behaviors and exposure to reinforcing environmental contingencies .


Although research has identified an inverse correlation between pleasant or rewarding activities and depression , the causal relation between increased structured activities and reduced depression has not directly been studied .


In the context of a recent randomized trial ( Hopko , Armento , et al. , @ ) , this study used longitudinal data and growth curve modeling to examine relationships among the quantity of activities completed , proportion of activities completed ( i.e. , therapeutic compliance ) , environmental reward , and depression in breast cancer patients treated with BA treatment for depression ( n = @ ) .


Therapeutic compliance with assigned activities was causally related to depression reduction , whereas the specific quantity of completed activities was not systematically related .


Logistic regression indicated that for patients completing all assigned activities , treatment response and remission were achieved for all patients .


Neither therapeutic compliance nor the quantity of completed activities was directly associated with self-reported environmental reward during the BA interval ( Session @ to posttreatment ) , and environmental reward did not mediate the relation between activation and depression .


Patient compliance with BA assignments is causally associated with depression reduction , whereas the quantity of completed activities is less relevant toward conceptualizing positive treatment outcome .


Study findings are discussed in the context of behavioral models of depression and BA therapy .


Our previous study , a @-month randomised controlled trial , demonstrated that a group-based support promoted weight loss as compared to an education-only intervention .


The purpose of this study was to examine weight loss maintenance for @ years .


Originally , @ overweight Japanese adults , aged @-@ years , were randomly assigned to @ groups : control , education-only or group-based support .


After the @-month intervention , @ participants in the education-only and the group-based support groups were followed up for @ years .


The primary outcome was the amount of weight lost .


The participants were retrospectively grouped into quartiles of percent weight loss for secondary analyses .


At the end of follow-up , the amount of weight lost in the education-only and the group-based support groups was the same ( @ kg ) .


Secondary analyses using data of those who completed the study ( n = @ ) revealed that the participants in the highest quartile of percent weight loss significantly increased their step counts and moderate-to-vigorous physical activity compared with the lowest quartile .


No significant differences were observed in the energy intake among the four groups .


The effects of group-based support disappear within @ years .


Increasing physical activity may be a crucial factor for successful maintenance of weight loss .


To date only a few randomized controlled studies have compared grafting strategies in patients with multi-vessel coronary disease .


This study represents a pilot RCT designed to test the feasibility of a trial comparing conventional CABG performed with a LIMA-LAD plus saphenous vein grafts ( LIMA+SVG ) and CABG performed with total arterial grafting ( TAG ) .


Consenting patients undergoing non-redo isolated CABG surgery at a single institution were randomized to TAG or LIMA+SVG groups .


Exclusion criteria included prior CABG , emergent procedure , concomitant procedure , varicose veins and renal dysfunction .


The primary endpoints were : enrolment > @ % and completion of CT coronary angiography at @ months > @ % .


Statistical investigation was performed on an intention to treat analysis .


Of @ eligible patients , @ were enrolled and @ withdrew ( n = @ in TAG , n = @ LIMA+SVG ) for @ % enrolment rate .


Patient characteristics were similar in each group .


No patients died in hospital and adverse events such as MI , stroke and deep sternal wound infection were not significantly different between groups .


Clinical follow-up was complete in @ % of patients , with @/@ ( @ % ) undergoing CT coronary angio at @ months .


Graft occlusion occurred in @ patients in each group for patency rates of @ % ( TAG ) and @ % ( LIMA+SVG ) .


We provide evidence that an RCT comparing grafting strategy is possible but also show that achieving recruitment or follow-up CT may be difficult .


Given the excellent patency results and little difference between groups , our findings suggest that the sample size required may make it infeasible to compare graft patency at @ months as a study end-point .


We measured the long-term retention of knowledge gained through selected American Academy of Neurology annual meeting courses and compared the effects of repeated quizzing ( known as test-enhanced learning ) and repeated studying on that retention .


Participants were recruited from @ annual meeting courses .


All participants took a pretest .


This randomized , controlled trial utilized a within-subjects design in which each participant experienced @ different postcourse activities with each activity performed on different material .


Each key information point from the course was randomized in a counterbalanced fashion among participants to one of the @ activities : repeated short-answer quizzing , repeated studying , and no further exposure to the materials .


A final test covering all information points from the course was taken @ months after the course .


Thirty-five participants across the @ courses completed the study .


Average score on the pretest was @ % .


Performance on the final test showed that repeated quizzing led to significantly greater long-term retention relative to both repeated studying ( @ % vs @ % ; t -LSB- @ -RSB- = @ , SEM = @ , p = @ , d = @ ) and no further exposure ( @ % vs @ % ; t -LSB- @ -RSB- = @ , SEM = @ , p = @ , d = @ ) .


Relative to the pretest baseline , repeated quizzing helped participants to retain almost twice as much of the knowledge acquired from the course compared to repeated studying or no further exposure .


Whereas annual meeting continuing medical education ( CME ) courses lead to long-term gains in knowledge , when repeated quizzing is added , retention is significantly increased .


CME planners may consider adding repeated quizzing to increase the impact of their courses .


Methylene blue ( MB ) has been shown to be safe and effective against falciparum malaria in Africa and to have pronounced gametocytocidal properties .


Three days of treatment with artesunate ( AS ) - amodiaquine ( AQ ) combined with MB was compared with AS-AQ treatment in a randomized controlled phase IIb study ; the study included @ children aged @-@ months with uncomplicated falciparum malaria in Burkina Faso .


The primary end point was gametocyte prevalence during follow-up , as determined by microscopy and real-time quantitative nucleic acid sequence-based amplification ( QT-NASBA ) .


The gametocyte prevalence of Plasmodium falciparum at baseline was @ % ( microscopy ) and @ % ( QT-NASBA ) .


It was significantly lower in the AS-AQ-MB than in the AS-AQ group on day @ of follow-up ( microscopy , @ % vs @ % -LSB- P < @ -RSB- ; QT-NASBA , @ % vs @ % -LSB- P < @ -RSB- ) .


Hemoglobin values were significantly lower in the AS-AQ-MB group than in the AS-AQ group at days @ and @ of follow-up .


Vomiting of the study medication occurred significantly more frequently in the AS-AQ-MB group .


The combination of MB with an artemisinin-based combination therapy has been confirmed to be effective against the gametocytes of P. falciparum .


MB-based combinations need to be compared with primaquine-based combinations , preferably using MB in an improved pediatric formulation .


Clinical Trials Registration : NCT@ .


To prospectively assess treatment response using volumetric functional magnetic resonance imaging ( MRI ) metrics in patients with hepatocellular carcinoma ( HCC ) treated with the combination of doxorubicin-eluting bead-transarterial chemoembolization ( DEB TACE ) and sorafenib .


A single center study enrolled @ patients treated with systemic sorafenib , @ mg twice a day , combined with DEB TACE .


All patients had a pre-treatment and @-@ week post-treatment MRI .


Anatomic response criteria ( RECIST , mRECIST and EASL ) and volumetric functional response ( ADC , enhancement ) were assessed .


Statistical analyses included paired Student 's t-test , Kaplan-Meier curves , Cohen 's Kappa , and multivariate cox proportional hazard model .


Median tumour size by RECIST remained unchanged post-treatment ( @ cm vs. @ cm , p = @ ) .


There was no significant survival difference for early response by RECIST ( p = @ ) .


EASL and mRECIST could not be analyzed in @ patients .


Volumetric ADC increased significantly ( @ ( -@ ) mm ( @ ) / sec to @ ( -@ ) mm ( @ ) / sec , p < @ ) , and volumetric enhancement decreased significantly in HAP ( @ % to @ % , p < @ ) and PVP ( @ % to @ % , p < @ ) .


Patients who demonstrated @ % decrease PVP enhancement had significantly improved overall survival compared to non-responders ( p < @ ) .


Volumetric PVP enhancement was demonstrated to be significantly correlated with survival in the combination of DEB TACE and sorafenib for patients with HCC , enabling precise stratification of responders and non-responders .


PVP enhancement is significantly correlated with survival in responders ( p < @ ) .


There was no significant survival difference for early response using RECIST ( p = @ ) .


mRECIST or EASL could not assess tumour response in @ % of patients .


To determine whether insulin delivered via a @-mm @-gauge pen needle ( PN ) provides equivalent glycemic control as @-mm @-gauge and @-mm @-gauge PNs in obese ( body mass index @ ) patients with diabetes .


This prospective , multicenter , randomized , open-label , @-period , crossover , equivalence , home-based study was conducted from October @ , @ , through May @ , @ .


After a @-week wash-in period , eligible patients aged @ to @ years with a hemoglobin A@c ( HbA@c ) level of @ % to @ % ( @-@ mmol/mol ) were randomized to compare either @ - vs @-mm PNs or @ - vs @-mm PNs , using each of the @ assigned PNs for @ weeks in random order .


The primary outcome was change in HbA@c level , with equivalence limits of @ % .


The @ patients randomized ( mean SD age , @ years ) had a mean SD body mass index of @ ( range , @-@ @ ) and took up to @ U of insulin daily ; @ patients were included in the modified intention-to-treat analysis .


Mean ( @ % CI ) changes in HbA@c levels with the @-mm PN were -@ % ( -@ to @ ) and -@ % ( -@ to @ ) vs the @ - and @-mm PNs , respectively , within equivalence margins .


The @-mm PN was less painful than the larger PNs ( P < @ ) , with similar leakage rates reported ( @ % -@ % ) .


Patients preferred the @-mm PN over the @-mm PN ( P < @ ) but not significantly vs the @-mm PN .


There were no differences between PNs in insulin doses and hypoglycemic or hyperglycemic adverse event rates .


The @-mm @-gauge PN provides equivalent glycemic control as @ - and @-mm PNs in obese patients with diabetes , with less pain and no increase in leakage .


Shorter PNs should be considered in all insulin-requiring patients with diabetes , including those who are obese .


External ventricular drainage ( EVD ) and lumbar drainage ( LD ) are the most widely used procedures for continued bloody cerebrospinal fluid drainage .


Each has his own advantages and disadvantages .


Here , we compared complications and clinical outcomes in patients with World Federation of Neurosurgical Societies ( WFNS ) grade III aneurysmal subarachnoid hemorrhage ( aSAH ) who underwent coil placement followed by EVD or LD .


In this prospective , controlled study , all patients with aSAH classified as WFNS grade III who underwent coil placement at our institution were divided randomly into @ groups : the EVD group and the LD group .


The ratios of intracerebral hemorrhage , vasospasm , infection , duration of catheter placement , hydrocephalus , and Glasgow outcome scale ( GOS ) after @ months of onset were analyzed between the @ groups .


A total of @ patients ( mean age @ years ) were enrolled in this study .


Seventy-six patients were assigned to the EVD group , and @ patients were assigned to the LD group .


The average time interval from stroke onset to surgery was @ h. Compared with the EVD group , the LD group had a lower incidence of intracerebral hemorrhage , slightly higher rates of infection and hydrocephalus , and similar vasospasm and chronic hydrocephalus rates , durations of catheter placement , and GOS scores at @ months after onset .


In order to improve the clinical outcomes of patients with aSAH , we suggest that LD is better than EVD for patients with WFNS grade III aSAH who underwent coil placement .


To investigate the effect of antibiotics on postoperative inflammatory complications after surgical extraction of the impacted mandibular third molar .


Ninety-Six patients had their bilateral third molars removed through a split-mouth , double-blind , controlled , clinical trial in two visits .


On one side amoxicillin ( or clindamycin ) was used ( antibiotics group ) from @ h pre-operation to @ d post-operation .


On the other side , placebo was used ( placebo group ) the same time .


Postoperative inflammatory complications including alveolar osteitis ( AO ) , surgical site infection ( SSI ) , pre-buccal site infection and anterior isthmus faucium space infection were monitored and recorded @ d and @ d after the surgery .


The pain , swelling , and trismus were also recorded .


All @ patients completed the study .


Two AO ( @ % ) , one SSI ( @ % ) and seven other infections were observed in the treatment group .


Also three AO ( @ % ) , one SSI ( @ % ) and eleven other infections were observed in the placebo group .


However , no statistically significant differences were found in the incidence of various postoperative inflammatory complications and reactions between the groups ( P > @ ) .


There was no significant difference on the postoperative reaction , except pain on @ d. Patients who had inflammatory infection recovered well with symptomatic anti-infection treatment .


The use of amoxicillin ( or clindamycin ) can not effectively prevent and reduce the postoperative inflammatory complications after surgical extraction of the impacted mandibular third molar .


The identification of the cause of chronic low back pain ( CLBP ) represents a great challenge to orthopedists due to the controversy over the diagnosis of discogenic low back pain ( DLBP ) and the existence of a number of cases of CLBP of unknown origin .


This study aimed to develop diagnostic models to distinguish DLBP from other forms of CLBP and to identify serum biomarkers for DLBP .


Serum samples were collected from patients with DLBP , chronic lumbar disc herniation ( LDH ) , or CLBP of unknown origin , and healthy controls ( N ) , and randomly divided into a training set ( n = @ ) and a blind test set ( n = @ ) .


Matrix-assisted laser desorption ionization time-of-flight mass spectrometry was performed for protein profiling of these samples .


After the discriminative ability of two most significantly differential peaks from each two groups was assessed using scatter plots , classification models were developed using differential peptide peaks to evaluate their diagnostic accuracy .


The identity of peptides corresponding to three representative differential peaks was analyzed .


The fewest statistically significant differential peaks were identified between DLBP and CLBP ( @ ) , followed by CLBP vs. N ( @ ) , DLBP vs. N ( @ ) , LDH vs. CLBP ( @ ) , DLBP vs. LDH ( @ ) , and LDH vs. N ( @ ) .


The discriminative ability of two most significantly differential peaks was poor in classifying DLBP vs. CLBP but good in classifying DLBP vs. LDH .


The accuracy of models for classification of DLBP vs. CLBP was not very high in the blind test ( forecasting ability , @ % ; sensitivity , @ % ) , although a higher accuracy was observed for classification of DLBP vs. LDH and LDH vs. N ( forecasting abilities , ~ @ % ; sensitivities , > @ % ) .


A further investigation of three representative differential peaks led to the identification of two peaks as peptides of complement C@ , and one peak as a human fibrinogen peptide .


Our findings benefit not only the diagnosis of CLBP but also the understanding of the differences between different forms of DLBP .


The ability to distinguish between different causes of CLBP and the identification of serum biomarkers may be of great value to diagnose different causes of DLBP and predict treatment efficacy .


The aim of this study was to evaluate the cost-effectiveness of a home-based palliative care model relative to usual care in expediting discharge or enabling patients to remain at home .


Economic evaluation of a pilot randomised controlled trial with @ days follow-up .


Mean costs and effectiveness were calculated for the Palliative Care Extended Packages at Home ( PEACH ) and usual care arms including : days at home ; place of death ; PEACH intervention costs ; specialist palliative care service use ; acute hospital and palliative care unit inpatient stays ; and outpatient visits .


PEACH mean intervention costs per patient ( $ @ ) were largely offset by lower mean inpatient care costs ( $ @ ) and in this arm , participants were at home for one additional day on average .


Consequently , PEACH is cost-effective relative to usual care when the threshold value for one extra day at home exceeds $ @ , or $ @ if only within-study days of hospital admission are costed .


All estimates are high uncertainty .


The results of this small pilot study point to the potential of PEACH as a cost-effective end-of-life care model relative to usual care .


Findings support the feasibility of conducting a definitive , fully powered study with longer follow-up and comprehensive economic evaluation .


Figitumumab is a human IgG@ monoclonal antibody targeting insulin-like growth factor @ receptor ( IGF-@R ) , with antitumor activity in prostate cancer .


This phase II trial randomized chemotherapy-nave men with progressing castration-resistant prostate cancer to receive figitumumab every @ weeks with docetaxel/prednisone ( Arm A ) or docetaxel/prednisone alone ( Arm B@ ) .


At progression on Arm B@ , patients could cross over to the combination ( Arm B@ ) .


Prostate-specific antigen ( PSA ) response was the primary endpoint ; response assessment on the two arms was noncomparative and tested separately ; H@ = @ versus HA = @ ( = @ ; = @ ) for Arm A ; H@ = @ versus HA = @ ( = @ , = @ ) for Arm B@ .


A comparison of progression-free survival ( PFS ) on Arms A and B@ was planned .


A total of @ patients were randomized and @ treated ( Arm A : @ ; Arm B@ : @ ) ; @ patients crossed over to Arm B@ ( median number of cycles started : Arm A = @ ; B@ = @ ; B@ = @ ) .


PSA responses occurred in @ % and @ % of Arms A and B@ , respectively ; the primary PSA response objective in Arm A was not met .


Median PFS was @ and @ months , respectively ( HR = @ ; @ % confidence interval , @-@ @ ) .


PSA response rate was @ % in Arm B@ .


The figitumumab combination appeared more toxic , with more treatment-related grade @/@ adverse events ( @ % vs. @ % ) , particularly hyperglycemia , diarrhea , and asthenia , as well as treatment-related serious adverse events ( @ % vs. @ % ) , and all-causality grade @ adverse events ( @ % vs. @ % ) .


IGF-@R targeting may merit further evaluation in this disease in selected populations , but combination with docetaxel is not recommended .


Central obesity in polycystic ovary syndrome ( PCOS ) is associated with increased inflammatory markers and increased risk for type @ diabetes .


The objective of the study was to evaluate whether treatment with metformin ( M ) or M combined with oral contraceptive pills ( OCPs ) resulted in a more advantageous body composition than treatment with OCP alone .


The study was conducted at an outpatient clinic .


This was a randomized , controlled clinical trial .


Ninety patients with PCOS were randomized to @ months ' treatment with M ( @ g/d ) , M + OCP ( @ mg desogestrel +@ g ethinylestradiol ) , or OCP .


Whole-body dual-energy x-ray absorptiometry scans and clinical and hormonal evaluations were performed before and after the intervention period .


A total of @ of @ patients completed the study .


Changes in weight at @ and @ months and changes in regional fat mass estimates at @ months were measured .


Dropout rates between intervention groups were not significantly different .


Treatment with M and M+OCP were superior to OCP regarding weight and regional fat mass .


The median ( quartiles ) weight changes during @ months of M , M+OCP , and OCP treatment were -@ ( -@ ; @ ) , -@ ( -@ ; @ ) , and @ ( -@ ; @ ) kg , respectively , P < @ .


Upper to lower fat mass ratio was unchanged .


Changes in body composition were predicted by the type of medical intervention ( M , M+OCP , or OCP ) and not by body mass index at study inclusion .


OCP and M+OCP were superior to M regarding reduction in free T levels .


M treatment alone or in combination with OCP was associated with weight loss and improved body composition compared with OCP , whereas free T levels decreased during M+OCP or OCP .


Combined treatment with M+OCP should be considered as an alternative to treatment with OCP alone to avoid weight gain in PCOS .


To compare visual acuity , intraocular lens ( IOL ) movement , and depth of focus with the Crystalens HD single-optic accommodating IOL and the Tecnis ZCB@ aspheric monofocal IOL .


St. Thomas ' Hospital , London , United Kingdom .


Prospective randomized controlled trial .


Patients with bilateral symptomatic cataract had bilateral sequential cataract surgery within @ weeks with randomized implantation of the accommodating or monofocal IOL in both eyes .


Exclusion criteria included other ocular conditions and corneal astigmatism greater than @ diopters .


The primary outcome was uniocular distance-corrected near visual acuity ( DCNVA ) .


Secondary measures were IOL movement , depth of focus , intermediate and distance vision , objective refraction , and pupil size at distance and near fixation .


Results from @ months postoperatively are presented .


Three months postoperatively , @ patients ( @ in each group ) were available for study .


The distance vision was not statistically significantly different between the accommodating IOL and monofocal IOL ( mean @ logMAR versus @ logMAR ) .


The mean DCNVA ( @ logMAR @ -LSB- SD -RSB- versus @ @ logMAR ) and intermediate visual acuity ( @ @ logMAR versus @ @ logMAR ) were significantly better with the accommodating IOL ( P < @ ) .


Neither IOL had clinically significant movement , and near vision did not directly correlate with movement of the accommodating IOL .


The accommodating IOL provided greater depth of focus .


Near and intermediate acuities were better with the accommodating IOL .


This effect was not directly linked to IOL movement but was at least partly due to depth of focus .


Whether addition of fluorouracil to epirubicin , cyclophosphamide , and paclitaxel ( EC-P ) is favourable in adjuvant treatment of patients with node-positive breast cancer is controversial , as is the benefit of increased density of dosing .


We aimed to address these questions in terms of improvements in disease-free survival .


In this @ factorial , open-label , phase @ trial , we enrolled patients aged @-@ years with operable , node positive , early-stage breast cancer from @ Italian centres .


Eligible patients were randomly allocated in a @:@:@:@ ratio with a centralised , interactive online system to receive either dose-dense chemotherapy ( administered intravenously every @ weeks with pegfilgrastim support ) with fluorouracil plus EC-P ( FEC-P ) or EC-P or to receive standard-interval chemotherapy ( administered intravenously every @ weeks ) with FEC-P or EC-P .


The primary study endpoint was disease-free survival , assessed with the Kaplan-Meier method in the intention-to-treat population .


Our primary comparisons were between dose schedule ( every @ weeks vs every @ weeks ) and dose type ( FEC-P vs EC-P ) .


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


Between April @ , @ , and July @ , @ , we recruited @ patients .


@ patients were enrolled in centres that only provided standard-intensity dosing .


After a median follow-up of @ years ( interquartile range -LSB- IQR -RSB- @-@ ) , @ ( @ % ) of @ patients given EC-P every @ weeks , @ ( @ % ) of @ patients given FEC-P every @ weeks , @ ( @ % ) of @ patients given EC-P every @ weeks , and @ ( @ % ) of @ patients given FEC-P every @ weeks had a disease-free survival event .


For the dose-density comparison , disease-free survival at @ years was @ % ( @ % CI @-@ ) in patients treated every @ weeks and @ % ( @-@ ) in patients treated every @ weeks ( HR @ , @ % CI @-@ ; p = @ ) ; overall survival rates at @ years were @ % ( @-@ ) and @ % ( @-@ ; HR @ , @-@ ; p = @ ) and for the chemotherapy-type comparison , disease-free survival at @ years was @ % ( @-@ ) in the FEC-P groups and @ % ( @-@ ) in the EC-P groups ( HR @ , @-@ ; p = @ ) ; overall survival rates at @ years were @ % ( @-@ ) and @ % ( @-@ ; @ , @-@ ; p = @ ) .


Compared with @ week dosing , chemotherapy every @ weeks was associated with increased rate of grade @-@ of anaemia ( @ -LSB- @ % -RSB- of @ patients vs two -LSB- @ % -RSB- of @ patients ; p = @ ) ; transaminitis ( @ -LSB- @ % -RSB- vs four -LSB- @ % -RSB- ; p = @ ) , and myalgias ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; p = @ ) , and decreased rates of grade @-@ neutropenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; p < @ ) .


Addition of fluorouracil led to increased rates of grade @-@ neutropenia ( @ -LSB- @ % -RSB- of @ patients on FEC-P vs @ -LSB- @ % -RSB- of @ patients on EC-P ; p < @ ) , fever ( nine -LSB- @ % -RSB- vs two -LSB- @ % -RSB- ) , nausea ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and vomiting ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


In patients with node-positive early breast cancer , dose-dense adjuvant chemotherapy improved disease-free survival compared with standard interval chemotherapy .


Addition of fluorouracil to a sequential EC-P regimen was not associated with an improved disease-free survival outcome .


We present and validate a multivariate model that partially compensates for retinal nerve fiber layer ( RNFL ) intersubject variability .


A total of @ healthy volunteers randomly attributed to a training ( TS ) and a validation ( VS ) sample underwent complete ophthalmic examination , including Fourier-domain optical coherence tomography ( FD-OCT ) .


We acquired FD-OCT data centered at the optic disc ( OD ) and the macula .


Two-dimensional ( @D ) projection images were computed and registered , to determine the distance between fovea and OD centers ( FD ) and their respective angle ( FA ) .


Retinal vessels were automatically segmented in the projection images and used to calculate the circumpapillary retinal vessel density ( RVD ) profile .


Using the TS , a multivariate model was calculated for each of @ sectors of the RNFL , including OD ratio , orientation and area , RVD , FD , FA , age , and refractive error .


Model selection was based on Akaike Information Criteria .


The compensation effect was determined for @ clock hour sectors , comparing the coefficients of variation ( CoV ) of measured and model-compensated RNFL thicknesses .


The model then was applied to the VS , and CoV was calculated .


The R value for the multivariate model was , on average @ ( max = @ ) .


Compensation reduced the CoV on average by @ % , both for the TS and VS ( up to @ % and @ % ) , respectively .


We have developed and validated a comprehensive multivariate model that may be used to create a narrower range of normative RNFL data , which could improve diagnostic separation between early glaucoma and healthy subjects .


This , however , remains to be demonstrated in future studies .


ACTION , a @-week , prospective , randomized , parallel-group , double-blind study in patients with severe Alzheimer 's disease ( AD ) , demonstrated significant efficacy of @ mg/@ h versus @ mg/@ h rivastigmine patch on the Severe Impairment Battery ( SIB ) and Alzheimer 's Disease Cooperative Study-Activities of Daily Living scale-Severe Impairment Version ( ADCS-ADL-SIV ) .


Overall , @ % of the study population received at least @ dose of concomitant memantine , regardless of dose or duration .


This retrospective analysis investigated the effects of concomitant memantine on the efficacy , safety and tolerability of @ mg/@ h versus @ mg/@ h rivastigmine patch .


Patients were stratified according to whether or not they received at least one dose of concomitant memantine during the double-blind phase .


Changes from baseline on the SIB and ADCS-ADL-SIV were compared using analysis of covariance ( ANCOVA ) with treatment , pooled center , memantine usage and treatment-by-memantine as factors , and baseline as a covariate .


Safety and tolerability were assessed .


Memantine-treated patients were younger than those not receiving memantine ( mean @ and @ years , respectively ) , with a lower screening Mini-Mental State Examination ( @ and @ , respectively ) .


ANCOVA confirmed there was no significant interaction ( p > @ ) between study treatment and memantine use on the SIB or ADCS-ADL-SIV .


The incidence of adverse events was : @ % , @ mg/@ h patch with memantine ; @ % , @ mg/@ h patch alone ; @ % , @ mg/@ h patch with memantine ; and @ % , @ mg/@ h patch alone .


These data suggest benefit of @ mg/@ h versus @ mg/@ h rivastigmine patch , regardless of concomitant memantine use .


The incidence of adverse events with highdose patch was similar in memantine-treated patients and those not receiving memantine .


Childhood asthma morbidity remains significant , especially in low-income children .


Most often , asthma management is provided by the child 's primary care provider .


We sought to evaluate whether enhancing primary care management for persistent asthma with telephone-based peer coaching for parents reduced asthma impairment and risk in children @ to @ years old .


Over @ months , peer trainers provided parents with asthma management training by telephone ( median , @ calls ) and encouraged physician partnership .


The intervention was evaluated in a cluster-randomized trial of @ intervention and @ usual care pediatric practices ( @ and @ families , respectively ) .


Patient outcomes were assessed by means of telephone interviews at @ and @ months conducted by observers blinded to intervention assignment and compared by using mixed-effects models , controlling for baseline values and clustering within practices .


In a planned subgroup analysis we examined the heterogeneity of the intervention effect by insurance type ( Medicaid vs other ) .


After @ months , intervention participation resulted in @ ( @ % CI , @-@ @ ) more symptom-free days per child than in the control group , and there was no difference in emergency department ( ED ) visits .


After @ months , ED visits were reduced ( difference in mean visits/child , -@ ; @ % CI , -@ to -@ ) , indicating a delayed intervention effect .


In the Medicaid subgroup , after @ months , intervention participation resulted in @ % fewer ED visits ( difference in mean visits/child , -@ ; @ % CI , -@ to -@ ) and @ % fewer hospitalizations ( difference in mean hospitalizations/child , -@ ; @ % CI , -@ to -@ ) .


Reductions in health care use endured through @ months .


This pragmatic telephone-based peer-training intervention reduced asthma impairment .


Asthma risk was reduced in children with Medicaid insurance .


The Study to Assess Long-term Opioid Medication Effectiveness ( SALOME ) is a two-stage phase III , single site ( Vancouver , Canada ) , randomized , double blind controlled trial designed to test if hydromorphone is as effective as diacetylmorphine for the treatment of long-term illicit opioid injection .


Recruiting participants for clinical trials continues to be a challenge in medical and addiction research , with many studies not being able to reach the planned sample size in a timely manner .


The aim of this study is to describe the recruitment strategies in SALOME , which offered appealing treatments but had limited clinic capacity and no guaranteed post-trial continuation of the treatments .


SALOME included chronic opioid-dependent , current illicit injection opioid users who had at least one previous episode of opioid maintenance treatment .


Regulatory approvals were received in June @ and recruitment strategies were implemented over the next @ months .


Recruitment strategies included ongoing open communication with the community , a consistent and accessible team and participant-centered screening .


All applicants completed a pre-screening checklist to assess prerequisites .


Applicants meeting these prerequisites were later contacted to commence the screening process .


A total of @ applications were received over the two-year recruitment period ; @ were received on the first day of recruitment .


Of these applicants , @ met prerequisites ; however , many could not be found or were not reached before recruitment ended .


For the @ candidates who initiated the screening process , the average time lapse between application and screening date was @ months ( standard deviation -LSB- SD -RSB- = @ ) and for the @ randomized to the study , the average processing time from initial screen to randomization was @ days ( SD = @ ; Median = @ ) .


As in prior trials offering injectable diacetylmorphine within a supervised model , recruiting participants for this study took longer than planned .


The recruitment challenges overcome in SALOME were due to the high number of applicants compared with the limited number that could be randomized and treated .


Our study emphasizes the value of integrating these strategies into clinical addiction research to overcome study-specific barriers .


To compare a single leukocyte-poor ( type-@B ) platelet-rich plasma ( PRP ) injection versus bupivacaine injection for recalcitrant lateral epicondylar tendinopathy ( LET ) .


@ patients aged @ to @ years with painful and recalcitrant LET of the humerus were randomised to receive leukocyte-poor ( type-@B ) PRP ( n = @ ) or bupivacaine ( n = @ ) injection .


Outcome measures included visual analogue scale ( VAS ) for pain , modified Mayo clinic performance index for elbow ( MMCPIE ) for elbow function , and Nirschl score for activity-related pain at @ , @ , @ , and @ months by a single assessor .


At baseline , the PRP and bupivacaine groups were comparable in terms of age , sex , duration of symptoms , VAS for pain , MMCPIE score , and Nirschl score .


After one month , the percentage of improvement was less in the PRP than bupivacaine group in terms of the VAS for pain ( @ % vs. @ % ) , MMCPIE score ( @ % vs. @ % ) , and Nirschl score ( @ % vs. @ % ) .


Nonetheless , improvement in the respective scores was greater in the PRP than bupivacaine group after @ months ( @ % vs. @ % , @ % vs. @ % , and @ % vs. @ % ) , @ months ( @ % vs. @ % , @ % vs. @ % , and @ % vs. @ % ) , and one year ( @ % vs. @ % , @ % vs. @ % , and @ % vs. @ % ) .


The differences in scores between groups were significant at @ months and one year only ( p < @ ) .


Leukocyte-poor ( type-@ ) PRP injection for recalcitrant LET enabled good improvement in pain and function .


Smoking cessation is a high-priority intervention to prevent CVD events and deaths in developing countries .


While several interventions to stop smoking have been proved successful , the question of how to increase their effectiveness and practicality in developing countries remains .


In this study , a newly devised evidence-based smoking cessation service package will be compared with the existing service in a randomized controlled trial within the community setting of Thailand .


This randomized control trial will recruit @ current smokers at CVD risk because of being diabetic and/or hypertensive .


Informed , consented participants will be randomly allocated into the new service-package arm and the routine service arm .


The study will take place in the non-communicable disease clinics of the Maetha District Hospital , Lampang , northern Thailand .


The new smoking-cessation service-package comprises ( @ ) regular patient motivation and coaching from the same primary care nurse over a @-month period ; ( @ ) monthly application of piCO + smokerlyzer to sustain motivation of smoker 's quitting attempt and provide positive feedback over a @-month period ; ( @ ) assistance by an assigned family member ; ( @ ) nicotine replacement chewing gum to relieve withdrawal symptoms .


This new service will be compared with the traditional routine service comprising the @A approach in a @-year follow-up .


Participants who consent to participate in the study but refuse to attempt quitting smoking will be allocated to the non-randomized arm , where they will be just followed up and monitored .


Primary outcome of the study is smoking cessation rate at @-year follow-up proven by breath analysis measuring carbomonoxide in parts per million in expired air .


Secondary outcomes are smoking cessation rate at the @-month follow-up , blood pressure and heart rate , CVD risk according to the Framingham general cardiovascular risk score , CVD events and deaths at the @-month follow-up , and the cost-effectiveness of the health service packages .


Intention-to-treat analysis will be followed .


Factors influencing smoking cessation will be analyzed by the structure equation model .


This multicomponent intervention , accessible at primary healthcare clinics , and focusing on the individual as well as the family and social environment , is unique and expected to work effectively .


Facing frequent stigma and discrimination , many people with mental illness have to choose between secrecy and disclosure in different settings .


Coming Out Proud ( COP ) , a @-week peer-led group intervention , offers support in this domain in order to reduce stigma 's negative impact .


To examine COP 's efficacy to reduce negative stigma-related outcomes and to promote adaptive coping styles ( Current Controlled Trials number : ISRCTN@ ) .


In a pilot randomised controlled trial , @ participants with mental illness were assigned to COP or a treatment-as-usual control condition .


Outcomes included self-stigma , empowerment , stigma stress , secrecy and perceived benefits of disclosure .


Intention-to-treat analyses found no effect of COP on self-stigma or empowerment , but positive effects on stigma stress , disclosure-related distress , secrecy and perceived benefits of disclosure .


Some effects diminished during the @-week follow-up period .


Coming Out Proud has immediate positive effects on disclosure - and stigma stress-related variables and may thus alleviate stigma 's negative impact .


Highly cross-linked polyethylene infused with vitamin E ( E-poly ) was developed to increase oxidative resistance without affecting mechanical properties .


We evaluated this type of polyethylene in a randomized clinical study that used radiostereometric analysis .


Our objective was to compare the early-term femoral head penetration of an E-poly liner with that of a heat-treated polyethylene liner , ArComXL .


We hypothesized that the clinical outcome at two years following total hip arthroplasty would be unaffected by the choice of polyethylene .


In this prospective study , sixty-one patients ( seventy hips ) with noninflammatory hip osteoarthritis and a median age of fifty-eight years were randomized to receive either an implant with an E-Poly or a heat-treated highly cross-linked polyethylene liner .


The patients were followed for two years and evaluated at three time points ( three months , one year , and two years ) .


The median proximal penetration in the E-poly group increased from @ mm at three months to @ mm at two years of follow-up .


Corresponding values for the ArComXL group were @ mm and @ mm .


In both groups , significantly increased penetration was observed between three months and two years ( E-poly , p = @ ; ArComXL , p < @ ) , but between one and two years , the increase was significant only in the control group ( E-poly , p = @ ; ArComXL , p = @ ) .


The femoral head penetration of E-poly was very low at two years .


Whether the increase observed between three months and two years was caused by creep , deformation , wear , or a combination of these can not be determined by our study .


There were no significant differences observed in femoral head penetration rates between E-poly and ArComXL .


Currently , the theoretical advantages of E-poly remain to be confirmed .


trans Palmitoleic acid ( t-@ :@ n-@ , or @:@ t@ in the nomenclature usually applied to trans fatty acids and used herein ) arouses great scientific interest because it has been suggested to serve as a biomarker for lower risks of type @ diabetes and coronary artery disease .


Although @:@ t@ has been assumed to derive from dietary sources , we examined the hypothesis that @:@ t@ might also be endogenously produced from its metabolic precursor vaccenic acid ( t-@ :@ n-@ or @:@ t@ ) .


We reevaluated fatty acid data obtained from one human intervention study and one cellular model in both of which @:@ t@ was supplemented .


Both studies have already been published , but to our knowledge , @:@ t@ has not yet been considered .


This reanalysis of the datasets was reasonable because a new methodology for identifying @:@ cis and trans isomers allowed us to address the subject presented in this article .


Data showed that the systemic or intracellular increase in @:@ t@ was strongly correlated with the increase in @:@ t@ after the dietary intake or cellular uptake of @:@ t@ .


The conversion rate in humans was , on average , @ % .


Our findings suggest that endogenous @:@ t@ is not , as has been assumed , exclusively diet derived but may also be produced by the partial oxidation of dietary @:@ t@ .


To determine the effectiveness of personal digital assistant devices on achievement of memory and organization goals in patients with poor memory after acquired brain injury .


Assessor blinded randomized controlled trial .


Specialist brain injury rehabilitation hospital ( inpatients and outpatients ) .


Adults with acquired brain impairments ( @ % traumatic brain injury ; aged @ years ) who were assessed as having functional memory impairment on the Rivermead Behavioural Memory Test ( General Memory Index ) .


Training and support to use a personal digital assistant for eight weeks to compensate for memory failures by an occupational therapist .


The control intervention was standard rehabilitation , including use of non-electronic memory aids .


Goal Attainment Scale which assessed achievement of participants ' daily memory functioning goals and caregiver perception of memory functioning ; and General Frequency of Forgetting subscale of the Memory Functioning Questionnaire administered at baseline ( pre-randomization ) and post intervention ( eight weeks later ) .


Forty-two participants with memory impairment were recruited .


Use of a personal digital assistant led to greater achievement of functional memory goals ( mean difference @ ( @ % confidence interval ( CI ) @ to @ ) , P = @ ) and improvement on the General Frequency of Forgetting subscale ( mean difference @ ( @ % CI @ to @ ) , P = @ ) .


Occupational therapy training in the use of a handheld computer improved patients ' daily memory function more than standard rehabilitation .


In searching for an optimal induction regimen , we conducted two separate randomized trials of @ living donor and @ deceased donor adult , primary kidney transplant recipients comparing antithymocyte globulin ( Thymoglobulin ) ( group A , N = @ ) versus alemtuzumab ( group B , N = @ ) versus daclizumab ( group C , N = @ ) , using exactly the same three treatment arms in each trial .


For the purpose of maximizing statistical power , results from the two randomized trials were combined .


Groups A and C received standard maintenance dosing with tacrolimus ( TAC ) , mycophenolate mofetil ( MMF ) , and corticosteroids .


Because of intense lymphodepletion expected with alemtuzumab use ( and hoped-for achievement of a truer immunoregulatory state ) , group B received lower TAC and MMF dosing and corticosteroid avoidance .


Long-term target TAC trough level and MMF dosing were @ to @ ng/mL and @,@ mg b.i.d. in groups A and C ; @ to @ ng/mL and @ mg b.i.d. in group B.


With median follow-up of @ months , biopsy-proven cute rejection incidence was similar in the three groups ( @/@ , @/@ , and @/@ , P = @ ) , but biopsy-proven chronic allograft injury incidence was significantly higher in group B ( @/@ ) in comparison with groups A ( @/@ ) and C ( @/@ ) combined ( P = @ ) .


Mean calculated creatinine clearance was significantly lower in group B versus the average of groups A and C means throughout @ months posttransplant ( @ vs. @ and @ at @ months , P = @ ) , and death-censored graft failure was significantly higher in group B ( @/@ ) versus groups A ( @/@ ) and C ( @/@ ) combined ( P = @ ) .


Total infection and new-onset diabetes after transplant rates were not significantly different .


Ad hoc analysis suggested that the inferior results in group B were specifically a result of reduced dosing and greater withholding of TAC and MMF occurring in that group .


Long-term results clearly indicate inferior clinical outcomes in group B.


In the past , bilateral contralateral routing of signals ( BICROS ) amplification incorporated omnidirectional microphones on the transmitter and receiver sides and some models utilized noise reduction ( NR ) on the receiver side .


Little research has examined the performance of BICROS amplification in background noise .


However , previous studies examining contralateral routing of signals ( CROS ) amplification have reported that the presence of background noise on the transmitter side negatively affected speech recognition .


Recently , NR was introduced as a feature on the receiver and transmitter sides of BICROS amplification , which has the potential to decrease the impact of noise on the wanted speech signal by decreasing unwanted noise directed to the transmitter side .


The primary goal of this study was to examine differences in the reception threshold for sentences ( RTS in dB ) using the Hearing in Noise Test ( HINT ) in a diffuse listening environment between unaided and three aided BICROS conditions ( no NR , mild NR , and maximum NR ) in the Tandem @ BICROS .


A secondary goal was to examine real-world subjective impressions of the Tandem @ BICROS compared to unaided .


A randomized block repeated measures single blind design was used to assess differences between no NR , mild NR , and maximum NR listening conditions .


Twenty-one adult participants with asymmetric sensorineural hearing loss ( ASNHL ) and experience with BICROS amplification were recruited from Washington University in St. Louis School of Medicine .


Participants were fit with the National Acoustic Laboratories ' Nonlinear version @ prescriptive target ( NAL-NL@ ) with the Tandem @ BICROS at the initial visit and then verified using real-ear insertion gain ( REIG ) measures .


Participants acclimatized to the Tandem @ BICROS for @ wk before returning for final testing .


Participants were tested utilizing HINT sentences examining differences in RTS between unaided and three aided listening conditions .


Subjective benefit was determined via the Abbreviated Profile of Hearing Aid Benefit ( APHAB ) questionnaire between the Tandem @ BICROS and unaided .


A repeated measures analysis of variance ( ANOVA ) was utilized to analyze the results of the HINT and APHAB .


Results revealed no significant differences in the RTS between unaided , no NR , mild NR , and maximum NR .


Subjective impressions using the APHAB revealed statistically and clinically significant benefit with the Tandem @ BICROS compared to unaided for the Ease of Communication ( EC ) , Background Noise ( BN ) , and Reverberation ( RV ) subscales .


The RTS was not significantly different between unaided , no NR , mild NR , and maximum NR .


None of the three aided listening conditions were significantly different from unaided performance as has been reported for previous studies examining CROS hearing aids .


Further , based on comments from participants and previous research studies with conventional hearing aids , manufacturers of BICROS amplification should consider incorporating directional microphones and independent volume controls on the receiver and transmitter sides to potentially provide further improvement in signal-to-noise ratio ( SNR ) for patients with ASNHL .


To determine the effectiveness of a client or care-provider strategy to improve the implementation of external cephalic version .


Cluster randomized controlled trial .


Twenty-five clusters ; hospitals and their referring midwifery practices randomly selected in the Netherlands .


Singleton breech presentation from @ weeks of gestation onwards .


We randomized clusters to a client strategy ( written information leaflets and decision aid ) , a care-provider strategy ( @-day counseling course focused on knowledge and counseling skills ) , a combined client and care-provider strategy and care-as-usual strategy .


We performed an intention-to-treat analysis .


Rate of external cephalic version in various strategies .


Secondary outcomes were the percentage of women counseled and opting for a version attempt .


The overall implementation rate of external cephalic version was @ % ( @ of @ eligible clients ) with a range between clusters of @-@ % .


Neither the client strategy ( OR @ , @ % CI @-@ @ ) nor the care-provider strategy ( OR @ , @ % CI @-@ @ ) showed significant improvements .


Results were comparable when we limited the analysis to those women who were actually offered intervention ( OR @ , @ % CI @-@ @ and OR @ , @ % CI @-@ @ ) .


Neither a client nor a care-provider strategy improved the external cephalic version implementation rate for breech presentation , neither with regard to the number of version attempts offered nor the number of women accepting the procedure .


Balance dysfunction after stroke limits patients ' general function and participation in daily life .


Previous researches have suggested that Tai Chi exercise could offer a positive improvement in older individuals ' balance function and reduce the risk of falls .


But convincing evidence for the effectiveness of enhancing balance function after stroke with Tai Chi exercise is still inadequate .


Considering the difficulties for stroke patients to complete the whole exercise , the current trial evaluates the benefit of Tai Chi Yunshou exercise for patients with balance dysfunction after stroke through a cluster randomization , parallel-controlled design .


A single-blind , cluster-randomized , parallel-controlled trial will be conducted .


A total of @ community health centers ( @ per arm ) will be selected and randomly allocated into Tai Chi Yunshou exercise group or balance rehabilitation training group .


Each community health centers will be asked to enroll @ eligible patients into the trial .


@minutes per each session , @ session per day , @ times per week and the total training round is @weeks .


Primary and secondary outcomes will be measured at baseline and @-weeks , @-weeks , @-weeks , @-week follow-up , @-week follow-up after randomization .


Safety and economic evaluation will also be assessed .


This protocol aims to evaluate the effectiveness of Tai Chi Yunshou exercise for the balance function of patients after stroke .


If the outcome is positive , this project will provide an appropriate and economic balance rehabilitation technology for community-based stroke patients .


Smoking and metabolic syndrome ( MetS ) are major public health problems in modern society and are important risk factors of cardiovascular disease ( CVD ) .


The association of smoking , MetS , and CVD is widely reported , but reports targeted to women are few .


In the present study , we evaluated risk factors , including visceral fat area ( VFA ) , for CVD and development of subclinical atherosclerosis in female smokers especially .


Subjects consisted of @ apparent healthy female and male smokers , and @ age-matched never-smokers who underwent a health examination in the Osaka University Health Care Center .


For female smokers , lifestyle and carotid intima-media thickness ( IMT ) were evaluated .


Triglycerides were significantly higher and high-density lipoprotein-cholesterol significantly lower in smokers than in never-smokers for both men and women .


However , VFA was significantly high only in smoking women when compared with never-smokers .


Multivariate analysis revealed that age , body mass index , and smoking were the independent predictors of high VFA in women .


In addition , annual IMT increase was significantly higher in smokers than never-smokers in women .


VFA was notably high in female smokers , but the difference was not observed in men .


Smoking habit is an important risk factor of visceral fat accumulation and progression of subclinical atherosclerosis in women .


Many tools have been developed to facilitate the insertion of the ProSeal laryngeal mask airway ( LMA ) insertion , which can be impeded by folding of its soft cuff .


The aim of this study was to compare the efficiency of ProSeal LMA insertion guided by a soft , direct optical Foley Airway Stylet Tool ( FAST ) with the standard introducer tool ( IT ) .


One hundred sixty patients undergoing general anesthesia using the ProSeal LMA as an airway management device were randomly allocated to either FAST-guided or IT-assisted groups .


Following ProSeal LMA insertion , the glottic and esophageal openings were identified using a fiberoptic bronchoscope introduced through the airway and the drain tube .


The primary outcomes were time taken to insert the ProSeal LMA and the success rate at the first attempt .


Secondary end points included ease of insertion , hemodynamic response to insertion , and postoperative adverse events recorded in the recovery room and on the first postoperative morning .


One hundred forty patients were included in the final analysis : @ in the FAST-guided group and @ in the IT-assisted group .


The success rate of FAST device-guided ProSeal LMA insertion ( @ % ) was broadly comparable with IT-assisted insertion ( @ % ) .


However , the time taken to insert the ProSeal LMA was significantly longer when the FAST technique was used ( p < @ ) .


The incidence of correct alignment of the airway tube and the drain tube did not differ significantly between the groups .


There were no significant differences in ease of insertion or hemodynamic responses to insertion , except that the incidence of postoperative sore throat was significantly higher in the FAST group on the first postoperative day ( @ % compared with @ % in the IT group ; p = @ ) .


Both FAST-guided and IT-assisted techniques achieved correct ProSeal LMA positioning , but the IT technique was significantly quicker and less likely to cause a sore throat .


The best available treatment for seasonal affective disorder ( SAD ) is light therapy .


Yet , this treatment does not prevent recurrence of depression in subsequent seasons .


The aim of the study is to gain preliminary insight in the efficacy of Mindfulness Based Cognitive Therapy ( MBCT ) in the prevention of SAD recurrence .


This is a randomized controlled pilot study , in which SAD patients in remission were randomly allocated to an individual format of MBCT or a control condition ( i.e. treatment as usual ) .


MBCT was given between May and June @ , when there was no presence of depressive symptoms .


The Inventory for Depressive Symptomatology Self-Report ( IDS-SR ) , which patients received on a weekly basis from September @ to April @ , was used to assess moment of recurrence ( @ ) and severity at moment of recurrence .


@ SAD patients were randomized to MBCT and @ to the control condition .


Kaplan-Meier survival curve showed that the groups did not differ in moment of recurrence ( ( @ ) @ , p = @ ) .


T-tests showed no group difference in mean IDS-SR scores at moment of recurrence ( t ( @ ) = -@ , p = @ ) .


The results are limited by small sample size ( n = @ ) and missing data of weekly IDS-SR assessments .


The findings of this pilot RCT suggest that individual MBCT is not effective in preventing a SAD recurrence when offered in a symptom free period ( i.e. spring ) .


To determine the effectiveness of an individually targeted Internet-based intervention with monetary incentives ( INCENT ) at reducing weight of overweight and obese employees when compared with a less-intensive intervention ( Livin ' My Weigh -LSB- LMW -RSB- ) @ months after program initiation .


Twenty-eight worksites were randomly assigned to either INCENT or LMW conditions .


Both programs used evidence-based strategies to support weight loss .


INCENT was delivered via daily e-mails over @ months while LMW was delivered quarterly via both newsletters and on-site educational sessions .


Generalized linear mixed models were conducted for weight change from baseline to @ months post-program and using an intention-to-treat analysis to include all participants with baseline weight measurements .


Across @ worksites , @,@ employees ( M = @ years of age ; @ % Caucasian ; @ % women ) participated .


Participants lost an average of @ lbs ( P < @ ) with a BMI decrease of @ kg/m ( @ ) ( P < @ ) and @ lbs ( P < @ ) with a BMI decrease of @ kg/m ( @ ) ( P < @ ) in INCENT and LMW , respectively .


The differences between INCENT and LMW in weight loss and BMI reduction were not statistically significant .


This study suggests that INCENT and a minimal intervention alternative may be effective approaches to help decrease the overall obesity burden within worksites .


To evaluate the efficacy and safety of etanercept in patients with enthesitis-related arthritis ( ERA ) in juvenile idiopathic arthritis ( JIA ) .


This was a @-phase study in JIA patients with active , refractory ERA .


Phase I was an open-label , uncontrolled @-week study period in which all patients were administered etanercept .


Patients considered to be treatment responders at week @ according to the American College of Rheumatology ( ACR ) Pediatric @ ( Pedi @ ) criteria for improvement in juvenile arthritis entered the second phase , a @-week randomized , double-blind , placebo-controlled withdrawal study , for an additional @ weeks , for evaluation of the primary end point , occurrence of a disease flare from week @ to week @ , based on the ACR preliminary definition of disease flare in juvenile arthritis .


Forty-one patients were enrolled .


At week @ , treatment with etanercept resulted in response rates of @ % , @ % , @ % , @ % , and @ % based on the ACR Pedi @ , Pedi @ , Pedi @ , Pedi @ , and Pedi @ criteria , respectively .


In addition , a marked decrease in all disease activity measures was observed .


The mean number of tender joints , swollen joints , and joints with active arthritis decreased by @ % , @ % , and @ % , respectively .


Physician 's global assessment of disease activity , parent 's assessment of patient 's overall well-being , and the Childhood Health Assessment Questionnaire disability index improved by @ % , @ % , and @ % , respectively .


The number of tender enthesis sites and total scores for back pain , nocturnal pain , Bath Ankylosing Spondylitis Disease Activity Index , Bath Ankylosing Spondylitis Functional Index , and Juvenile Arthritis Disease Activity Score based on @-joint counts ( JADAS@ ) decreased by @ % , @ % , @ % , @ % , @ % , and @ % , respectively .


In phase II , @ patients were randomly assigned to receive placebo ( n = @ ) or to continue receiving etanercept ( n = @ ) .


Up to week @ , @ disease flares occurred , in @ patients receiving placebo and @ patients receiving etanercept ( odds ratio @ , P = @ ) .


There were no serious infections , malignancies , or deaths .


In this study of patients with the ERA category of JIA , etanercept proved effective , as indicated by high ACR Pedi response rates and JADAS@ response rates at week @ .


Patients who continued treatment with etanercept had significantly fewer flares than those who received placebo , although @ % of patients in the placebo group did not experience a flare .


Treatment suspension may be a consideration for patients with the ERA category of JIA who achieve remission .


Lactase non-persistence ( LNP ) , or primary hypolactasia , is a genetic condition that mediates lactose malabsorption and can cause lactose intolerance .


Here we report the prevalence of lactose intolerance in a double-blind placebo study .


The LCT C > T-@ variant was genotyped by RT-PCR in @ volunteers and lactose malabsorption was assessed using the hydrogen breath test ( HBT ) after consuming @ g of lactose .


Lactose intolerance was assessed by scoring symptoms ( SS ) using a standardized questionnaire following challenge with a lactose solution or saccharose placebo .


The LNP genotype was observed in @ % of the volunteers , among whom @ % were HBT .


In the HBT group the median SS was @ and in the HBT group the median SS was @ ( p < @ ) .


No difference was observed in the SS when both groups were challenged with the placebo .


The most common symptoms included audible bowel sounds , abdominal pain and meteorism .


In the ROC curve analysis , an SS @ demonstrated @ % sensitivity and @ % specificity for predicting a positive HBT .


To estimate prevalence , lactose intolerance was defined as the presence of an SS @ points after subtracting the placebo effect and @ % of the study population met this definition .


The LNP genotype was present in more than half of subjects evaluated and the observed prevalence of lactose intolerance was @ % .


We performed a randomised trial in very preterm , small for gestational age ( SGA ) babies to determine if prophylaxis with granulocyte macrophage colony stimulating factor ( GM-CSF ) improves outcomes ( the PROGRAMS trial ) .


GM-CSF was associated with improved neonatal neutrophil counts , but no change in other neonatal or @-year outcomes .


As subtle benefits in outcome may not be ascertainable until school age we performed an outcome study at @years .


@ babies born at @weeks of gestation or less and SGA were entered into the trial .


Outcomes were assessed at @years to determine neurodevelopmental and general health status and educational attainment .


We found no significant differences in cognitive , general health or educational outcomes between @ of @ ( @ % ) surviving children in the GM-CSF arm compared with @ of @ ( @ % ) in the control arm .


Mean mental processing composite ( equivalent to IQ ) at @years were @ ( SD @ ) compared with @ ( SD @ ) , respectively ( difference in means -@ ( @ % CI -@ to @ ) , and similar proportions were in receipt of special educational needs support ( @ % vs @ % ; risk ratio @ ( @ % CI @ to @ ) ) .


Performance on Kaufmann-ABC subscales and components of NEPSY were similar .


The suggestion of worse respiratory outcomes in the GM-CSF group at @years was replicated at @years .


The administration of GM-CSF to very preterm SGA babies is not associated with improved or more adverse neurodevelopmental , general health or educational outcomes at @years .


Today 's children are more overweight than previous generations and physical inactivity is a contributing factor .


Modelling and promoting positive behaviour in the early years is imperative for the development of lifelong health habits .


The social and physical environments where children spend their time have a powerful influence on behaviour .


Since the majority of preschool children spend time in care outside of the home , this provides an ideal setting to examine the ability of an intervention to enhance movement skills and modify physical activity behaviour .


This study aims to evaluate the efficacy of the Activity Begins in Childhood ( ABC ) intervention delivered in licensed daycare settings alone or in combination with a parent-driven home physical activity-promotion component to increase preschoolers ' overall physical activity levels and , specifically , the time spent in moderate to vigorous physical activity .


This study is a single site , three-arm , cluster-randomized controlled trial design with a daycare centre as the unit of measurement ( clusters ) .


All daycare centres in the National Capital region that serve children between the ages of @ and @ , expressing an interest in receiving the ABC intervention will be invited to participate .


Those who agree will be randomly assigned to one of three groups : i ) ABC program delivered at a daycare centre only , ii ) ABC program delivered at daycare with a home/parental education component , or iii ) regular daycare curriculum .


This study will recruit @ daycare centres , @ in each of the three groups .


The intervention will last approximately @months , with baseline assessment prior to ABC implementation and follow-up assessments at @ and @months .


Physical activity is an acknowledged component of a healthy lifestyle and childhood experiences as it has an important impact on lifelong behaviour and health .


Opportunities for physical activity and motor development in early childhood may , over the lifespan , influence the maintenance of a healthy body weight and reduce cardiovascular disease risk .


If successful , the ABC program may be implemented in daycare centres as an effective way of increasing healthy activity behaviours of preschoolers .


To observe the impact of plant sterol esters ( PSE ) mixed in low fat milk powder ( @ g of PSE/day ) on plasma cholesterol levels in hypercholesterolemic subjects during a @-week intervention period .


In this double-blind , randomized , placebo-controlled study , @ subjects ( @ males , mean age ( @ @ ) years ) with primary hypercholesterolemia ( fasting LDL cholesterol between @-@ @ mmol/L ) were randomly divided into two groups ( treatment group , @ g of plant sterol esters a day , n = @ ) and placebo group ( n = @ ) .


Blood samples were collected at week @ , @ and @ .


The primary outcome was change in plasma LDL-cholesterol ( LDL-C ) .


Secondary outcomes were changes in total cholesterol ( TC ) , HDL cholesterol ( HDL-C ) , triglycerides ( TG ) , anthropometry and blood biochemistry .


LDL-C significantly reduction from baseline ( @ @ ) mmol/L to ( @ @ ) mmol/L ( -@ % , P < @ ) at week @ and ( @ @ ) mmol/L ( -@ % , P < @ ) at week @ in the treatment group , whereas in placebo group from ( @ @ ) mmol/L at baseline to ( @ @ ) mmol/L ( -@ % , P < @ ) and ( @ @ ) mmol/L ( -@ % , P < @ ) at week @ and week @ , respectively .


TC was reduced from ( @ @ ) mmol/L at baseline to ( @ @ ) mmol/L ( -@ % , P > @ ) at week @ and ( @ @ ) mmol/L ( -@ % , P < @ ) at week @ in treatment group , from ( @ @ ) mmol/L at week @ to ( @ @ ) mmol/L ( -@ % , P < @ ) at week @ and ( @ @ ) mmol/L ( -@ % , P < @ ) at week @ in placebo group .


PSE-enriched milk did not affect plasma HDL-C level and TG level at both week @ and week @ .


After normalization to the placebo group , the treatment group showed significant reduction in LDL-C and total cholesteron after @ weeks .


The observed difference of reduction was @ % ( -@ mmol/L , P < @ ) for LDL-C and @ % ( -@ mmol/L , P < @ ) for TC between the two groups .


There were no significant changes in safety parameters , including blood biochemistry tests during the study period .


Plant sterol ester enriched milk powder is effective in reducing LDL-C among Chinese hypercholesterolemic subjects at a dosage recommended by EFSA .


One of the most dreaded complications of septic shock is acute kidney injury .


It occurs in around @ % of patients , with a mortality rate of about @ % at @ months .


There is no consensus on the optimal time to initiate renal replacement therapy .


Retrospective and observational studies suggest that early implementation of renal replacement therapy could improve the prognosis for these patients .


This protocol summarizes the rationale and design of a randomized , controlled , multicenter trial investigating the effect of early versus delayed renal replacement therapy in patients with severe acute kidney injury in early septic shock .


In total , @ critically ill adults with septic shock and evidence of acute kidney injury , defined as the failure stage of the RIFLE classification , will be enrolled .


The primary outcome is mortality at @ days .


Secondary outcomes include safety , number of days free of mechanical ventilation , number of days free of renal replacement therapy , intensive care length of stay , in-hospital length of stay , quality of life as evaluated by the EQ-@D and renal replacement therapy dependence at hospital discharge .


The primary analysis will be intention to treat .


Recruitment started in March @ and will be completed by March @ .


This protocol for a randomized controlled study investigating the impact of the timing of renal replacement therapy initiation should provide an answer to a key question for the management of patients with acute kidney injury in the context of septic shock , for whom the mortality rate remains close to @ % despite improved understanding of physiopathology and recent therapeutic advances .


To investigate the safety and efficacy of low-concentration inhaled nitric oxide ( NO ) in the treatment of hypoxic respiratory failure ( HRF ) among premature infants .


Sixty premature infants ( gestational age @ weeks ) with HRF were randomized into NO and control groups between @ and @ , with @ cases in each group .


Both groups received nasal continuous positive airway pressure ( nCPAP ) or mechanical ventilation .


NO inhalation was continued for at least @ days or until weaning in the NO group .


The general conditions , blood gas results , complications , and clinical outcomes of the two groups were analyzed .


The NO group showed significantly more improvement in blood gas results than the control group after @ hours of treatment ( P < @ ) .


After that , the change in oxygenation status over time showed no significant difference between the two groups ( P > @ ) .


There were no significant differences in total time of assisted ventilation and duration of oxygen therapy between the two groups ( P > @ ) .


The incidence of bronchopulmonary dysplasia ( BPD ) , patent ductus arteriosus , necrotizing enterocolitis , retinopathy of prematurity , and pneumothorax in infants showed no significant differences between the NO and control groups ( P > @ ) , but the incidence of IVH and mortality were significantly lower in the NO group than in the control group ( @ % vs @ % , P < @ ; @ % vs @ % , P < @ ) .


NO inhalation may improve oxygenation status and reduce the mortality in premature infants with HRF , but it can not reduce the incidence of BPD and the total time of mechanical ventilation or nCPAP and duration of oxygen therapy .


NO therapy may have a brain-protective effect for premature infants with HRF and does not increase clinical complications .


To explore the clinical efficacies of different internal fixation materials in the treatment of senile proximal humerus fractures .


A total of @ hospitalized patients of proximal humerus fractures over @ years of age cases from October @ to February @ were randomly divided into two groups of locking proximal humeral plate ( LPHP ) and PHILOS ( n = @ each ) .


And the clinical efficacies of two groups were compared .


For PHILOS and LPHP groups , the fracture healing periods were ( @ @ ) and ( @ @ ) weeks .


And there was statistical significance ( P < @ ) .


At @ months post-surgery , the incidence of pain was @ % and @ % .


At @ years , Neer shoulder function score had inter-group statistically insignificant difference ( P > @ ) .


Both PHILOS and LPHP are effective in the treatment of senile proximal humeral fractures.However , the former is conducive to fracture healing and has shorter healing time and lowered postoperative pain .


Few studies have addressed the rehabilitation of hand function in persons with severe impairment following stroke , and few therapeutic options are available for treatment .


We investigated whether an intervention of robot-assisted movement and muscle vibration could reduce impairment and enable hand-opening to a greater extent when combined with torque biofeedback or electromyographic ( EMG ) biofeedback .


Forty-three participants with severe hand impairment due to chronic stroke ( @ year poststroke ) were randomized to @ of @ treatment groups receiving assisted movement and muscle vibration combined with either torque or EMG biofeedback .


Each participant received @ sessions ( @ minutes duration per session ) directed at the impaired hand over @ to @ weeks .


Outcomes were assessed using the Upper Extremity Fugl-Meyer Assessment ( UE-FMA ) , Stroke Impact Scale , and Box-and-Block Test scores .


Twenty-eight of @ participants had no baseline finger extension ; the remainder had an average of @ @ mm extension in the most active finger .


Assisted movement and muscle vibration were associated with a significant increase in all outcome measures across both treatment groups , and for the UE-FMA and Stroke Impact Scale within treatment groups , with no significant difference between groups .


Based on the Box-and-Block Test scores , the assisted movement and muscle vibration intervention did not restore functional hand-opening to participants with baseline UE-FMA scores less than @/@ , regardless of the form of biofeedback .


Assisted movement and muscle vibration , combined with either EMG or torque biofeedback , appears to reduce upper limb impairment , improve volitional activation of the hand muscles , and restore a modicum of hand function in some persons with severe hand impairment due to chronic stroke.Video Abstract available ( see Video , Supplemental Digital Content @ , http://links.lww.com/JNPT/A@ ) for more insights from the authors .


The optimal perioperative blood glucose range to improve surgical site infection ( SSI ) in surgical intensive care unit ( ICU ) patients remains unclear .


We sought to determine whether the incidence of SSI is reduced by perioperative intensive insulin therapy ( IT ) .


Patients were randomly assigned to receive perioperative intensive IT , with a target blood glucose range of @-@ @ mmol/L , or intermediate IT , with a target blood glucose range of @-@ @ mmol/L in the surgical ICU .


We defined the primary end point as the incidence of SSI .


Study participants were randomly assigned to glucose control with one of two target ranges : for @ patients in the intermediate IT group or for @ patients in the intensive IT group , respectively .


No patients in either group became hypoglycemic ( < @ mmol/L ) during their stay in the surgical ICU .


In our series , the rate of SSI after hepato-biliary-pancreatic surgery was @ % .


Patients in the intensive IT group , compared with the intermediate IT group , had fewer postoperative SSIs ( @ % vs. @ % , P = @ ) and a lower incidence of postoperative pancreatic fistula after pancreatic resection ( P = @ ) .


The length of hospitalization required for patients in the intensive IT group was significantly shorter than that in the intermediate IT group ( P = @ ) .


We found that intensive IT decreased the incidence of SSI among patients who underwent hepato-biliary-pancreatic surgery : a blood glucose target of @ to @ mmol/L resulted in lower rate of SSI than did a target of @-@ @ mmol/L .


Phylogenetic comparative analyses usually rely on a single consensus phylogenetic tree in order to study evolutionary processes .


However , most phylogenetic trees are incomplete with regard to species sampling , which may critically compromise analyses .


Some approaches have been proposed to integrate non-molecular phylogenetic information into incomplete molecular phylogenies .


An expanded tree approach consists of adding missing species to random locations within their clade .


The information contained in the topology of the resulting expanded trees can be captured by the pairwise phylogenetic distance between species and stored in a matrix for further statistical analysis .


Thus , the random expansion and processing of multiple phylogenetic trees can be used to estimate the phylogenetic uncertainty through a simulation procedure .


Because of the computational burden required , unless this procedure is efficiently implemented , the analyses are of limited applicability .


In this paper , we present efficient algorithms and implementations for randomly expanding and processing phylogenetic trees so that simulations involved in comparative phylogenetic analysis with uncertainty can be conducted in a reasonable time .


We propose algorithms for both randomly expanding trees and calculating distance matrices .


We made available the source code , which was written in the C++ language .


The code may be used as a standalone program or as a shared object in the R system .


The software can also be used as a web service through the link : http://purl.oclc.org/NET/sunplin/ .


We compare our implementations to similar solutions and show that significant performance gains can be obtained .


Our results open up the possibility of accounting for phylogenetic uncertainty in evolutionary and ecological analyses of large datasets .


We compared the effect of clopidogrel plus aspirin vs aspirin alone on functional outcome and quality of life in the Clopidogrel in High-risk Patients with Acute Non-disabling Cerebrovascular Events ( CHANCE ) trial of aspirin-clopidogrel vs aspirin alone after acute minor stroke or TIA .


Participants were assessed at @ days for functional outcome using the modified Rankin Scale ( mRS ) and quality of life using the EuroQol-@ Dimension ( EQ-@D ) .


Poor functional outcome was defined as mRS score of @-@ at @ days and poor quality of life as EQ-@D index score of @ or less .


Poor functional outcome occurred in @ patients ( @ % ) in the clopidogrel-aspirin group , as compared with @ ( @ % ) in the aspirin group ( p = @ ) .


Poor quality of life occurred in @ ( @ % ) in the clopidogrel-aspirin group and in @ ( @ % ) in the aspirin group ( p = @ ) .


Disabling stroke at @ days occurred in @ ( @ % ) in the clopidogrel-aspirin group and in @ ( @ % ) in the aspirin group ( p = @ ) .


In stratified analysis by subsequent stroke , there was no difference in @-day functional outcome and quality of life between the @ groups .


In patients with minor stroke or TIA , the combination of clopidogrel and aspirin appears to be superior to aspirin alone in improving the @-day functional outcome , and this is consistent with a reduction in the rate of disabling stroke in the dual antiplatelet arm .


This study provides Class II evidence that for patients with acute minor stroke or TIA , clopidogrel plus aspirin compared to aspirin alone improves @-day functional outcome ( absolute reduction of poor outcome @ % , @ % confidence interval @ % -@ % ) .


Treatment for advanced-stage epithelial ovarian cancer ( AEOC ) includes primary debulking surgery ( PDS ) or neoadjuvant chemotherapy ( NACT ) .


A randomized controlled trial comparing these treatments resulted in comparable overall survival ( OS ) .


Studies report more complications and lower chemotherapy completion rates in patients @ years old or older receiving PDS .


We sought to evaluate the cost implications of NACT relative to PDS in AEOC patients @ years old or older .


A @ year Markov model was created .


Arm @ modeled PDS followed by @ cycles of carboplatin and paclitaxel ( CT ) .


Arm @ modeled @ cycles of CT , followed by interval debulking surgery and then @ additional cycles of CT. .


Parameters included OS , surgical complications , probability of treatment initiation , treatment cost , and quality of life ( QOL ) .


OS was assumed to be equal based on the findings of the international randomized control trial .


Differences in surgical complexity were accounted for in base surgical cost plus add-on procedure costs weighted by occurrence rates .


Hospital cost was a weighted average of diagnosis-related group costs weighted by composite estimates of complication rates .


Sensitivity analyses were performed .


Assuming equal survival , NACT produces a cost savings of $ @ .


If PDS improved median OS by @ months or longer , PDS would be cost effective ( CE ) at a $ @,@ / quality-adjusted life-year threshold .


If PDS improved OS by @ months or longer , it would be CE at a $ @,@ threshold .


The model was robust to variation in costs and complication rates .


Moderate decreases in the QOL with NACT would result in PDS being CE .


A model based on the RCT comparing NACT and PDS showed NACT is a cost-saving treatment compared with PDS for AEOC in patients @ years old or older .


Small increases in OS with PDS or moderate declines in QOL with NACT would result in PDS being CE at the $ @,@ / quality-adjusted life-year threshold .


Our results support further evaluation of the effects of PDS on OS , QOL and complications in AEOC patients @ years old or older .


Aortic dissection is a lift-threatening medical emergency associated with high rates of morbidity and mortality .


The incidence rate of aortic dissection is estimated at @ to @ per @ million people per year .


The prompt and correct diagnosis of aortic dissection is critical .


This study was to compare the ascending aortic image quality and the whole aortic radiation dose of high-pitch dual-source CT angiography and conventional dual-source CT angiography .


A total of @ consecutive patients with suspected aortic dissection and other aortic disorders were randomly divided into two groups .


Group A underwent traditional scan mode and Group B underwent high-pitch dual-source CT scan mode .


The image quality and radiation dose of two groups were compared .


Close interobserver agreement was found for image quality scores ( = @ ) .


The image quality of ascending aorta was significantly better in the high-pitch group than in the conventional group ( @ @ vs @ @ , P < @ ) .


There was no significant difference of the CT attenuation values , the aortic image noise and SNR between two groups .


The mean radiation dose of high-pitch group was also significantly lower than that of conventional group ( @ @ mSv vs. @ @ mSv , P < @ ) .


High-pitch dual-source CT angiography of the whole aorta can provide motion-artifact-free imaging of the ascending aorta at a low radiation dose compared to conventional protocol .


To evaluate ictal adipokine levels in episodic migraineurs and their association with pain severity and treatment response .


This was a double-blind , placebo-controlled trial evaluating peripheral blood specimens from episodic migraineurs at acute pain onset and @ to @ minutes after treatment with sumatriptan/naproxen sodium vs placebo .


Total adiponectin ( T-ADP ) , ADP multimers ( high molecular weight -LSB- HMW -RSB- , middle molecular weight , and low molecular weight -LSB- LMW -RSB- ) , leptin , and resistin levels were evaluated by immunoassays .


Thirty-four participants ( @ responders , @ nonresponders ) were included .


In all participants , pretreatment pain severity increased with every quartile increase in both the HMW : T-ADP ratio ( coefficient of variation -LSB- CV -RSB- @ ; @ % confidence interval -LSB- CI -RSB- : @ , @ ; p = @ ) and resistin levels ( CV @ ; @ % CI : @ , @ ; p = @ ) , but was not associated with quartile changes in leptin levels .


In responders , T-ADP ( CV -@ ; @ % CI : -@ , -@ ; p = @ ) and resistin ( CV -@ ; @ % CI : -@ , -@ ; p = @ ) levels decreased @ minutes after treatment as compared with pretreatment .


In addition , in responders , the HMW : T-ADP ratio ( CV -@ ; @ % CI : -@ , -@ ; p = @ ) decreased and the LMW : T-ADP ratio ( CV @ ; @ % CI : @ , @ ; p = @ ) increased at @ minutes after treatment .


In nonresponders , the LMW : T-ADP ratio ( CV -@ ; @ % CI : -@ , -@ ; p = @ ) decreased @ minutes after treatment .


Leptin was not associated with treatment response .


Both pretreatment migraine pain severity and treatment response are associated with changes in adipokine levels .


Adipokines represent potential novel migraine biomarkers and drug targets .


The benefit of novel implantable cardioverter defibrillator ( ICD ) programming in reducing inappropriate ICD therapy and mortality was demonstrated in Multicenter Automatic Defibrillator Implantation Trial-Reduce Inappropriate Therapy ( MADIT-RIT ) .


However , the cause of mortality reduction remains incompletely evaluated .


We aimed to identify factors associated with mortality , with focus on ICD therapy and programming in the MADIT-RIT population .


In MADIT-RIT , @ patients with a primary prophylactic indication for ICD or cardiac resynchronization therapy with defibrillator were randomized to @ of @ different ICD programming arms : conventional programming ( ventricular tachycardia zone @ beats per minute ) , high-rate programming ( ventricular tachycardia zone @ beats per minute ) , and delayed programming ( @-second delay before therapy @ beats per minute ) .


Multivariate Cox models were used to assess the influence of time-dependent appropriate and inappropriate ICD therapy ( shock and antitachycardia pacing ) and randomized programming arm on all-cause mortality .


During an average follow-up of @ years , @ of @ ( @ % ) patients died : cardiac in @ patients ( @ % ) , noncardiac in @ patients ( @ % ) , and unknown in @ patients ( @ % ) .


Appropriate shocks ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) and inappropriate therapy ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) were significantly associated with an increased mortality risk .


There was no evidence of increased mortality risk in patients who experienced appropriate antitachycardia pacing only ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


Randomization to conventional programming was identified as an independent predictor of death when compared with patients randomized to high-rate programming ( hazard ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


In MADIT-RIT , appropriate shocks , inappropriate ICD therapy , and randomization to conventional ICD programming were independently associated with an increased mortality risk .


Appropriate antitachycardia pacing was not related to an adverse outcome .


Depression is common in patients with chronic kidney disease who are on hemodialysis .


Available behavioral modalities for treating depression may not be feasible for patients who receive hemodialysis two or three times per week .


The purpose of this randomized controlled trial was to examine the efficacy of a nurse-led , in-center breathing training program in reducing depressive symptoms and improving sleep quality and health-related quality of life in patients on maintenance hemodialysis .


Fifty-seven patients on hemodialysis were randomly assigned either to an eight-session breathing training group or to a control group .


The Beck Depression Inventory II ( BDI-II ) , the Pittsburgh Sleep Quality Index ( PSQI ) , and the Medical Outcome Studies @-Item Short Form Health Survey ( SF-@ ) were used to assess self-reported depressive symptoms , sleep quality , and health-related quality of life , respectively .


The intervention group exhibited significantly greater decreases in BDI-II scores than the control group .


No significant differences in PSQI change scores were observed between the groups .


SF-@ change scores for both the domain of role limitation due to emotional problems and the mental component summary were significantly higher in the breathing training group than in the control group .


This intervention significantly alleviated depressive symptoms , reduced perceived role limitation due to emotional problems , and improved the overall mental health component of quality of life in patients on maintenance hemodialysis .


WHO recommends hospital-based treatment for young infants aged @-@ days with clinical signs of possible serious bacterial infection , but most families in resource-poor settings can not accept referral .


We aimed to assess whether use of simplified antibiotic regimens to treat young infants with clinical signs of severe infection was as efficacious as an injectable procaine benzylpenicillin-gentamicin combination for @ days for situations in which hospital referral was not possible .


In a multisite open-label equivalence trial in DR Congo , Kenya , and Nigeria , community health workers visited all newborn babies at home , identifying and referring unwell young infants to a study nurse .


We stratified young infants with clinical signs of severe infection whose parents did not accept referral to hospital by age ( @-@ days and @-@ days ) , and randomly assigned each individual within these strata to receive one of the four treatment regimens .


Randomisation was stratified by age group of infants .


An age-stratified randomisation scheme with block size of eight was computer-generated off-site at WHO .


The outcome assessor was masked .


We randomly allocated infants to receive injectable procaine benzylpenicillin-gentamicin for @ days ( group A , reference group ) ; injectable gentamicin and oral amoxicillin for @ days ( group B ) ; injectable procaine benzylpenicillin-gentamicin for @ days , then oral amoxicillin for @ days ( group C ) ; or injectable gentamicin for @ days and oral amoxicillin for @ days ( group D ) .


Trained health professionals gave daily injections and the first dose of oral amoxicillin .


Our primary outcome was treatment failure by day @ after enrolment , defined as clinical deterioration , development of a serious adverse event ( including death ) , no improvement by day @ , or not cured by day @ .


Independent outcome assessors , who did not know the infant 's treatment regimen , assessed study outcomes on days @ , @ , @ , and @ .


Primary analysis was per protocol .


We used a prespecified similarity margin of @ % to assess equivalence between regimens .


This study is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN@ .


In Kenya and Nigeria , we started enrolment on April @ , @ , and we enrolled the necessary number of young infants aged @ days or older from Oct @ , @ , to April @ , @ .


At these sites , we continued to enrol infants younger than @ days until March @ , @ .


In DR Congo , we started enrolment on Sept @ , @ , and continued until June @ , @ .


We randomly assigned @ young infants to either group A ( n = @ ) , group B ( n = @ ) , group C ( n = @ ) , or group D ( n = @ ) .


We excluded @ randomly assigned infants , who did not fulfil the predefined criteria of adherence to treatment and adequate follow-up .