The styletted tip ( difference : @ % ; @ % confidence interval -LSB- CI -RSB- : @ to @ ; P < @ ) was found to improve ease of insertion .


Both the posterior-facing bevel ( difference : @ % ; @ % CI : @ to @ ; P = @ ) and stylet ( difference : @ % ; @ % CI : @ to @ ; P < @ ) contributed significantly to absence of epistaxis .


Using a styletted tracheal tube with a posterior-facing bevel improves ease of insertion through the nasopharynx and decreases the severity of epistaxis during nasal intubation .


Rapid blood pressure ( BP ) control improves dyspnea in hypertensive acute heart failure ( AHF ) .


Although effective antihypertensives , calcium-channel blockers are poorly studied in AHF .


Clevidipine is a rapidly acting , arterial selective intravenous calcium-channel blocker .


Our purpose was to determine the efficacy and safety of clevidipine vs standard-of-care intravenous antihypertensive therapy ( SOC ) in hypertensive AHF .


This is a randomized , open-label , active control study of clevidipine vs SOC in emergency department patients with AHF having systolic BP @ mm Hg and dyspnea @ on a @-mm visual analog scale ( VAS ) .


Coprimary end points were median time to , and percent attaining , a systolic BP within a prespecified target BP range ( TBPR ) at @ minutes .


Dyspnea reduction was the main secondary end point .


Of @ patients ( mean -LSB- SD -RSB- age @ -LSB- @ -RSB- years , @ % female , @ % African American ) , @ received clevidipine and @ received SOC .


Baseline mean ( SD ) systolic BP and VAS dyspnea were @ ( @ ) mm Hg and @ ( @ ) mm .


More clevidipine patients ( @ % ) reached TBPR than did those receiving SOC ( @ % ; P = @ ) , and clevidipine was faster to TBPR ( P = @ ) .


At @ minutes , clevidipine patients had greater mean ( SD ) VAS dyspnea improvement than did SOC patients ( -@ -LSB- @ -RSB- vs -@ mm -LSB- @ -RSB- , P = @ ) , a difference that remained significant up to @ hours .


Serious adverse events ( @ % vs @ % ) and @-day mortality ( @ vs @ ) were similar between clevedipine and SOC , respectively , and there were no deaths during study drug administration .


In hypertensive AHF , clevidipine safely and rapidly reduces BP and improves dyspnea more effectively than SOC .


Nonadherence and medication errors are common among patients with complex drug regimens .


Apps for smartphones and tablets are effective for improving adherence , but they have not been tested in elderly patients with complex chronic conditions and who typically have less experience with this type of technology .


The objective of this study was to design , implement , and evaluate a medication self-management app ( called ALICE ) for elderly patients taking multiple medications with the intention of improving adherence and safe medication use .


A single-blind randomized controlled trial was conducted with a control and an experimental group ( N = @ ) in Spain in @ .


The characteristics of ALICE were specified based on the suggestions of @ nominal groups with a total of @ patients and a focus group with @ professionals .


ALICE was designed for Android and iOS to allow for the personalization of prescriptions and medical advice , showing images of each of the medications ( the packaging and the medication itself ) together with alerts and multiple reminders for each alert .


The randomly assigned patients in the control group received oral and written information on the safe use of their medications and the patients in the experimental group used ALICE for @ months .


Pre and post measures included rate of missed doses and medication errors reported by patients , scores from the @-item Morisky Medication Adherence Scale ( MMAS-@ ) , level of independence , self-perceived health status , and biochemical test results .


In the experimental group , data were collected on their previous experience with information and communication technologies , their rating of ALICE , and their perception of the level of independence they had achieved .


The intergroup intervention effects were calculated by univariate linear models and ANOVA , with the pre to post intervention differences as the dependent variables .


Data were obtained from @ patients ( @ and @ in the control and experimental groups , respectively ) .


Patients in the experimental group obtained better MMAS-@ scores ( P < @ ) and reported fewer missed doses of medication ( P = @ ) .


ALICE only helped to significantly reduce medication errors in patients with an initially higher rate of errors ( P < @ ) .


Patients with no experience with information and communication technologies reported better adherence ( P < @ ) , fewer missed doses ( P < @ ) , and fewer medication errors ( P = @ ) .


The mean satisfaction score for ALICE was @ out of @ .


In all , @ of @ patients ( @ % ) felt that ALICE improved their independence in managing their medications .


The ALICE app improves adherence , helps reduce rates of forgetting and of medication errors , and increases perceived independence in managing medication .


Elderly patients with no previous experience with information and communication technologies are capable of effectively using an app designed to help them take their medicine more safely .


To discuss the effect and safety of preventive administration of antibiotics to patients with benign prostatic hyperplasia ( BPH ) before urodynamic examination .


A total of @ BPH patients to undergo urodynamic examination were randomly divided into a control group ( n = @ ) and a trial group ( n = @ ) .


The former received no pre-treatment while the latter were given cefoxitin sodium iv at @ g @ minutes before complete urodynamic examination .


Then we compared the incidence rates of urinary tract infection between the two groups .


Statistically significant differences were found in the incidence rate of urinary tract infection between the control and trial groups ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- , P < @ ) , as well as in those with diabetes mellitus ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- , P < @ ) , those with residual urine > @ ml ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- , P < @ ) , and those with both diabetes mellitus and residual urine ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- , P < @ ) .


Only @ patients ( @ % ) in the trial group had mild adverse drug reactions .


For BPH patients , particularly those with diabetes mellitus and residual urine , preventive administration of antibiotics before urodynamic examination is safe and can effectively protect the patients against urinary tract infection .


To assess the clinical efficacy of acupuncture pretreatment for the prevention of stroke based on promoting the circulation of the Governor Vessel and regulating mentality , and explore its effect mechanism .


Seventy cases of transient ischemic attack ( TIA ) were randomized into an acupuncture group ( @ cases ) and a western medicine group ( @ cases ) .


In the acupuncture group , acupuncture therapy of promoting the circulation of the Governor Vessel and regulating mentality was applied at Yaoyangguan ( GV @ ) , Mingmen ( GV @ ) , Zhiyang ( GV @ ) , Shenzhu ( GV @ ) , Dazhui ( GV @ ) , Yamen ( GV @ ) , Fengfu ( GV @ ) , Baihui ( GV @ ) and Neck-Jiaji ( EX-B @ ) .


Acupuncture was given @ times a week , at the interval of one day between two weeks .


Totally , @ days of treatment were taken as a session .


In the western medicine group , aspirin enteric coated tablets were prescribed , @ mg/tablet , @ mg/day , once a night for oral administration , and @ days of medication were taken as @ session .


There were @ days at the interval between two sessions in each group and totally @ sessions were required .


Transcranial Doppler ( TCD ) was adopted before treatment and in two sessions of treatment to observe , mean flow velocity ( Vm ) of middle cerebral artery ( MCA ) , vertebral artery ( VA ) , basilar arte ry ( BA ) and pulsatility index ( PI ) .


The standard of the efficacy assessment of stroke aura was taken as the main efficacy index in the assessment of theraputic effect , the adverse reaction was observed .


@In TIA , MCA blood flow was accelerated in internal carotid system , and BA blood flow was accelerated in vertebral-basilar artery system .


The treatments in the two groups enabled the blood flow in the responsible blood vessels slow down and the results in the acupuncture group L ( @ + / -@ ) cm/s , ( @ + / -@ ) cm/s -RSB- were better than those in the western medicine group -LSB- ( @ + / -@ ) cm/s , ( @ + / -@ ) cm/s -RSB- ( P < O. @ ) .


@The results of clinical efficacy and adverse reactions in the acupuncture group -LSB- @ % ( @/@ ) ,@ % ( @/@ ) -RSB- were superior to the western medicine group -LSB- @ % ( @/@ ) ,@ % ( @/@ ) -RSB- ( both P < @ ) .


@Concerning to the recurrence of disease at the different period after treatment , the case number of cerebral infarction was not different significantly between the two groups ( P > @ ) .


Acupuncture intervention based on promoting the circulation of the Governor Vessel and regulating mentality achieves the superior efficacy on TIA and less adverse reactions as compared with aspirin .


The effect mechanism is related potentially to the improvement of cerebral vascular hemodynamic .


Persons with severe and persistent mental disorders ( SPMD ) have extremely low earnings levels and account for @ percent of all U.S. Social Security Disability Income ( SSDI ) disabled worker beneficiaries under age @ .


Social insurance and disability policy experts pointed to several factors that may contribute to this situation , including disincentives and obstacles in the SSDI program , as well as lack of access to evidence-based behavioral-health interventions .


In response , the Social Security Administration ( SSA ) funded the Mental Health Treatment Study ( MHTS ) demonstration that included @,@ beneficiaries of SSDI whose primary reason for disability is SPMD .


The demonstration , implemented in @ different localities , consisted of two evidence-based services ( individual placement and support supported employment ( IPS-SE ) , systematic medication management ( SMM ) ) , and provision or coverage of additional behavioral-health services ( OBH ) .


This study focused on estimating MHTS intervention effects on earnings in the intervention period ( two-years ) .


The main outcome variable was self-reported average monthly earnings .


Subjects were randomly assigned to intervention or control groups .


Data were drawn from the baseline survey , seven follow-up quarterly surveys , a final follow-up survey , and SSA administrative data .


In all surveys , respondents were asked about earnings prior to the interview .


Dependent variables were average past-@-days earnings reported in all follow-up surveys , similar averages for the first four follow-ups and for the last four follow-ups , fraction of surveys with prior earnings above SSA 's substantial gainful activity ( SGA ) threshold , and final-follow-up earnings for the past @ days .


Regression analyses compared earnings of intervention vs. control group subjects .


Covariates included baseline values of : ( i ) beneficiary demographic and social characteristics ; ( ii ) beneficiary physical and mental health indicators ; ( iii ) beneficiary recipiency history ; ( iv ) beneficiary pre-recruitment and baseline earnings ; and ( v ) local labor-market unemployment rates .


Results show significant positive MHTS earnings impacts .


Estimated annual increases of earnings range from USD@ ( based on the @-year average ) to USD@ ,@ ( based on the final quarter of Year @ ) .


Effects on the fraction of quarters with earnings exceeding SGA are positive and significant but very small in magnitude .


The consistent increase in earnings impacts over the study period suggests the possibility of even larger impacts with longer-term interventions .


The moderate size of the intervention impacts may partly be explained by a study population that already had an average of @ years on SSDI , and whose labor-supply decisions continued to be affected by concerns about possible loss of benefits .


Limitations are that ( i ) earnings effects of specific intervention components can not be estimated since all treatment subjects received the same package of services , and ( ii ) study results may not generalize to the majority of the beneficiary population due to selection effects in beneficiaries ' participation decisions .


Replication of the MHTS on a broader scale should show similar positive earnings impacts for a substantial number of beneficiaries with characteristics similar to the study population .


Future studies should consider reducing policy barriers to labor supply of persons with SPMD .


Future studies should consider longer-term interventions , or at least measuring impacts for follow-up periods greater than two years .


To evaluate the feasibility and effectiveness of a telemedicine system based on internet in the follow-up of patients with type @ diabetes mellitus ( T@DM ) .


A prospective randomized telemedicine study with two parallel groups was designed .


@ patients diagnosed T@DM were randomly divided into telemedicine group and traditional face-to-face visit group as control .


@ cases were included for each group .


@ patients completed the trial , in which @ cases in telemedicine group and @ cases in control group .


Patients in telemedicine group were taught to use telemedicine software to upload their blood glucose and other metabolic information at home at least every @ weeks , and the researchers gave proper advices according to patients ' key behaviors .


The telemedicine interval is @ months .


Compared to control group , telemedicine group exhibited better HbA@c and fasting blood glucose controlling ( P < @ ) .


Moreover , telemedicine intervention decreased hypoglycemia risk ( P = @ ) , and contributed to levels of HbA@c less than @ % which is the target of our study ( P = @ ) .


Telemedicine system can provide a tighter glycemic control for the treatment of T@DM patients , especially in cases with difficulties to access to the medical centre .


Staging for liver fibrosis is recommended in the management of hepatitis C as an argument for treatment priority .


Our aim was to construct a noninvasive algorithm to predict the significant liver fibrosis ( SLF ) using common biochemical markers and compare it with some existing models .


The study group included @ consecutive cases ; SLF was defined as Ishak fibrosis stage greater than @ .


The patient population was assigned randomly to the training and the validation groups of @ cases each .


The training group was used to construct the algorithm from parameters with the best predictive value .


Each parameter was assigned a score that was added to the noninvasive fibrosis score ( NFS ) .


The accuracy of NFS in predicting SLF was tested in the validation group and compared with APRI , FIB@ , and Forns models .


Our algorithm used age , alkaline phosphatase , ferritin , APRI , @ macroglobulin , and insulin and the NFS ranged from -@ to @ .


The probability of SLF was @ versus @ % in NFS < @ and NFS > @ , leaving NFS = @ in a gray zone ( @ % of cases ) .


The area under the receiver operating curve was @ and @ , with a specificity , sensitivity , and diagnostic accuracy of @ , @ , and @ % versus @ , @ , and @ % for the training and the validation group .


In comparison , the area under the receiver operating curve for APRI = @ , FIB@ = @ , and Forns = @ with a diagnostic accuracy of @ , @ , and @ % and gray zone cases in @ , @ , and @ % .


We devised an algorithm to calculate the NFS to predict SLF with good accuracy , fewer cases in the gray zone , and a straightforward clinical interpretation .


NFS could be used for the initial evaluation of the treatment priority .


Nearly @ % of substance dependent individuals also use tobacco , and smoking cessation efforts during treatment for other substance use is associated with similar or even improved outcomes .


However , smoking cessation is not routinely addressed during treatment for substance use disorders .


The present study tested a computerized brief motivational intervention ( C-BMI ) for smoking cessation in an understudied population : a cohort recruited from a recovery community organization ( RCO ) center .


Following baseline assessment , participants were randomly assigned to either a @-minute C-BMI plus access to free nicotine replacement therapy ( NRT ) , or an information-only control group plus NRT access .


Reductions in CO were observed for both groups .


Quit rates in the C-BMI group ( @ % -@ % , vs. @ % for the control group ) approximated those observed elsewhere for physician advice and minimal counseling .


Participants in the C-BMI group were also more likely to express a desire to quit .


Computer-delivered smoking cessation interventions within RCOs appear feasible .


These organizations treat a wide variety of individuals , and C-BMIs for smoking in this context have the potential to reduce smoking-related morbidity and mortality .


Patients with Marfan ( MFS ) and Loeys-Dietz ( LDS ) syndromes have been shown to have abnormal aortic biophysical properties .


The purpose of this study was to compare the effects of @-months of therapy with atenolol or losartan on vascular function in young patients with MFS and LDS .


Seventeen patients with MFS or LDS were recruited and randomized to treatment with atenolol , @-@mg , or losartan , @mg daily .


Prior to treatment and following therapy , echocardiography for left ventricular size , function and aortic root size was performed .


Pulse wave velocity ( PWV ) , input ( Zi , ZiF ) and characteristic ( Zc , ZcF ) impedances , arterial stiffness ( Ep and - index ) , total arterial compliance ( TAC ) , mean ( Wm ) and total ( Wt ) hydraulic power , efficiency , power cost per unit of forward flow ( Wt/CI ) and brachial artery flow-mediated dilation ( FMD ) were measured .


The atenolol group consisted of @ females ( @ years ) and the losartan group @ males and @ female ( @ years ) .


Their height , weight , BSA , BMI , systolic and diastolic blood pressures were similar .


Baseline to @-month changes for atenolol and losartan were PWV ( @ % vs -@ % ) , Zi ( -@ % vs -@ % ) , Zc ( -@ % vs -@ % ) , Ep ( @ % , vs -@ % ) , - index ( @ % vs @ % ) , FMD ( @ % vs @ % ) , TAC ( @ % vs @ % ) , Wm ( -@ % vs @ % ) , Wt ( -@ % vs @ % ) , and Wt/CI ( @ % vs @ % ) .


There was a trend for losartan to decrease PWV and stiffness indexes while atenolol decreased power and power/unit flow .


This pilot study suggests that atenolol and losartan may have different mechanisms of action on vascular function .


A larger clinical trial is needed to confirm these effects.Clinical trials registration NCT@ ( ClinicalTrials.gov ) .


Matrix metalloproteinases ( MMPs ) and cytokines play a role of extracellular matrix degradation and remodelling , and are significantly involved in the course of periodontal disease .


The purpose of this study was to evaluate the adjunctive effect of administering an oxicam non-steroidal anti-inflammatory drug ( NSAID ) , tenoxicam , during non-surgical ( phase @ ) periodontal treatment on clinical parameters and gingival crevicular fluid ( GCF ) levels of MMP-@ and TNF - in subjects with chronic periodontitis .


A total of @ subjects with chronic periodontitis were randomized into two groups : @ ) phase I periodontal treatment + NSAID and @ ) phase I periodontal treatment + placebo .


Phase I periodontal therapy consisted of scaling and root planning ( SPR ) , which was provided by a single therapist masked with respect to group assignment .


Patients in group @ received a systemic NSAID ( @ mg tenoxicam tablet once daily for @ days ) .


Clinical measures and GCF samples were obtained immediately prior to periodontal treatment and @ days afterwards from all subjects .


Clinical measures included a plaque index , gingival index , gingival bleeding time index , probing depth , and clinical attachment level .


The MMP-@ and TNF - levels in the GCF were assayed using an enzyme-linked immunosorbent assay .


With the exception of clinical attachment level , all clinical measures showed a significant ( p < @ ) improvement following non-surgical treatment in both the NSAID and placebo groups .


A significant decrease in MMP-@ levels ( p < @ ) was observed at post-treatment in the NSAID group but not in the placebo group ( p > @ ) .


Treatment exhibited no effect on TNF - levels ( p > @ ) .


There was also no statistically significant difference in clinical measurements after treatment between the two groups ( p > @ ) .


Moreover , the post treatment MMP-@ level in group @ was statistically significant higher than the placebo group ( p < @ ) .


The adjunctive administration of tenoxicam during phase I periodontal treatment decreases MMP-@ levels in gingival crevicular fluid in patients with chronic periodontitis .


But no benefits were observed .


Prophylactic vaccination of youngwomen aged @ to @ years with the @-valent ( @/@/@ / @/@/@ / @/@/@ ) human papillomavirus ( HPV ) virus-like particle ( @vHPV ) vaccine prevents infection and disease .


We conducted a noninferiority immunogenicity study to bridge the findings in young women to girls and boys aged @ to @ years .


Subjects ( N = @ ) received a @-dose regimen of @vHPV vaccine administered at day @ , month @ , and month @ .


Anti-HPV serologic assays were performed at day @ and month @ .


Noninferiority required that the lower bound of @-sided @ % confidence intervals of geometric mean titer ratios ( boys : young women or girls : young women ) be > @ for each HPV type .


Systemic and injection-site adverse experiences ( AEs ) and serious AEs were monitored .


At @ weeks after dose @ , > @ % of girls , boys , and young women seroconverted for each vaccine HPV type .


Increases in geometric mean titers to HPV types @/@/@ / @/@/@ / @/@/@ were elicited in all vaccine groups .


Responses in girls and boys were noninferior to those of young women .


Persistence of anti-HPV responses was demonstrated through @ years after dose @ .


Administration of the @vHPV vaccine was generally well tolerated .


A lower proportion of girls ( @ % ) and boys ( @ % ) than young women ( @ % ) reported injection-site AEs , most of which were mild to moderate in intensity .


These data support bridging the efficacy findings with @vHPV vaccine in young women @ to @ years of age to girls and boys @ to @ years of age and implementing gender-neutral HPV vaccination programs in preadolescents and adolescents .


To evaluate safety of balugrastim , a recombinant human serum albumin and granulocyte colony-stimulating factor ( G-CSF ) , administered over a range of therapeutic doses in women with breast cancer receiving doxorubicin plus docetaxel chemotherapy .


The phase I , sequential dose-escalation first segment compared subcutaneous balugrastim @ , @ , @ , and @g/kg during chemotherapy cycles @-@ .


The randomized ( @:@:@ ) , open-label , phase IIa second segment compared balugrastim @ or @g/kg with pegfilgrastim @mg during chemotherapy cycles @ and @ .


In the phase I segment , balugrastim was escalated to @g/kg in @ patients without dose-limiting toxicity .


Three ( @ % ) of the @ adverse events ( AEs ) reported in nine patients were grade @ ( agranulocytosis , vomiting , hypertension ) ; none was grade @ .


In the open-label phase IIa segment ( N = @ ) , the majority of the @ AEs reported in @ ( @ % ) balugrastim-treated patients were grade @ ( @ % ) , with @ % grade @ , @ % grade @ ( one AE of vomiting ) , and none grade @ .


Of the @ AEs reported in seven ( @ % ) pegfilgrastim-treated patients , @ % were grade @ , @ % were grade @ , @ % were grade @ ( one AE of thrombocytopenia ) , and none were grade @ .


Overall , there were six bone pain AEs reported , one in the balugrastim @g/kg group and five in the balugrastim @g/kg group .


No AEs in either study necessitated treatment interruption/discontinuation .


The incidence and duration of grade @-@ neutropenia were similar between balugrastim - and pegfilgrastim-treated patients .


Balugrastim was well tolerated in this small population of breast cancer patients .


This study investigated the effects of aortic root infusion of sufentanil on myocardial ischemia/reperfusion injury in patients undergoing elective mitral valve replacement ( MVR ) with cardiopulmonary bypass ( CPB ) .


A prospective , randomized , clinical study .


A university-affiliated teaching hospital .


Fifty-three adult patients undergoing elective MVR with CPB .


Bolus infusions of sufentanil ( @ g/kg , n = @ ) or normal saline ( n = @ ) were administered through the aortic root cardioplegia perfusion catheter @ minutes before aortic unclamping .


Plasma concentrations of CK-MB and cTnI and variables including heart rate , mean arterial pressure , central venous pressure , cardiac output , stroke volume , duration of mechanical ventilation , length of ICU stay , length of hospital stay , and @-hour postoperative inotropic scores were recorded .


Plasma concentrations of CK-MB and cTnI were significantly lower @ and @ hours after aortic unclamping in the sufentanil postconditioning group compared to control ( p < @ ) .


Inotropic drug use , duration of mechanical ventilation , and length of ICU and hospital stays were reduced significantly in the sufentanil postconditioning group compared to control ( p < @ ) .


The present study demonstrated that sufentanil can attenuate myocardial ischemia-reperfusion injury in patients undergoing elective MVR with CPB .


Preclinical and epidemiologic studies suggest chemopreventive effects of green tea ( GT ) and black tea ( BT ) in prostate cancer .


In the current study we determined the effect of GT and BT consumption on biomarkers related to prostate cancer development and progression .


In this exploratory , open label , phase II trial @ men diagnosed with prostate cancer were randomized to consume six cups daily of brewed GT , BT or water ( control ) prior to radical prostatectomy ( RP ) .


The primary endpoint was prostate tumor markers of cancer development and progression determined by tissue immunostaining of proliferation ( Ki@ ) , apoptosis ( Bcl-@ , Bax , Tunel ) , inflammation ( nuclear and cytoplasmic nuclear factor kappa B -LSB- NFB -RSB- ) and oxidation ( @-hydroxydeoxy-guanosine -LSB- @OHdG -RSB- ) .


Secondary endpoints of urinary oxidation , tea polyphenol uptake in prostate tissue , and serum prostate specific antigen ( PSA ) were evaluated by high performance liquid chromatography and ELISA analysis .


Ninety three patients completed the intervention .


There was no significant difference in markers of proliferation , apoptosis and oxidation in RP tissue comparing GT and BT to water control .


Nuclear staining of NFB was significantly decreased in RP tissue of men consuming GT ( P = @ ) but not BT ( P = @ ) compared to water control .


Tea polyphenols were detected in prostate tissue from @ of @ men consuming GT but not in the other groups .


Evidence of a systemic antioxidant effect was observed ( reduced urinary @OHdG ) only with GT consumption ( P = @ ) .


GT , but not BT or water , also led to a small but statistically significant decrease in serum prostate-specific antigen ( PSA ) levels ( P = @ ) .


Given the GT-induced changes in NFB and systemic oxidation , and uptake of GT polyphenols in prostate tissue , future longer-term studies are warranted to further examine the role of GT for prostate cancer prevention and treatment , and possibly for other prostate conditions such as prostatitis .


The objective of the study was to compare the efficacy of external fixation and volar plating on the functional parameter of displaced intra-articular ( Cooney 's type IV ) distal end radius fractures using the Green and O'Brien scoring system .


This prospective randomized study comprised @ patients treated with external fixation and @ patients treated with volar locking plates .


The patients were followed up at @ months and @ year after surgery .


The assessment of pain , range of motion , grip strength and activity were assessed at each follow-up visit and scored according to the Green and O'Brien scoring system .


At @ year after surgery , we observed that external fixation showed significantly better results than volar locking plates using the Green and O'Brien scores for range of motion ( @ @ vs @ @ ) , grip strength ( @ @ vs @ @ ) and final outcome ( @ @ vs @ @ ) .


No difference was found in pain and activity between these two groups of patients .


Patients aged < @ years treated with external fixation showed excellent results ( final score ( @ @ ) at @ year follow-up .


External fixation showed superiority over volar locked plating after @ year of surgery .


Aim of the present study was to compare the effectiveness of two renin-angiotensin-aldosterone system inhibitors in arterial stiffness reduction in previously untreated hypertensive patients .


In this open label study , @ nave , or not treated in the last six months hypertensive patients were randomly assigned to receive aliskiren @ mg or ramipril @ mg daily .


Six weeks after the initiation of treatment , patients were evaluated for blood pressure ( BP ) control .


Patients with SBP @ and/or DBP @ mmHg were assigned to an adjunct of @ mg hydrochlorothiazide as combination treatment .


A re-evaluation of BP control was done after another @ weeks .


Individuals with BP @/@ mmHg were further administered amlodipine @ mg .


The final evaluation was performed six months after the start of the study .


Twenty four-hour ambulatory blood pressure monitoring was carried out and the ambulatory arterial stiffness index ( AASI ) was calculated at baseline and after @ months of treatment .


Aliskiren-based therapy , as compared with ramipril-based therapy reduced BP to a similar degree : @ vs. @ mmHg reduction in systolic ( P = @ ) and @ vs. @ mmHg reduction in diastolic BP ( P = @ ) .


AASI was reduced by @ in the aliskiren group and by @ in the ramipril group .


AASI reduction did not differ significantly in the two groups ( P = @ ) .


In hypertensive patients , aliskiren-based treatment as well as ramipril-based treatment appears to have a beneficial effect on arterial stiffness .


As arterial stiffness is an important modifiable risk factor , our findings highlight the value of aliskiren beyond BP lowering properties .


Scattered-site housing with Intensive Case Management ( ICM ) may be an appropriate and less-costly option for homeless adults with mental illness who do not require the treatment intensity of Assertive Community Treatment .


To examine the effect of scattered-site housing with ICM services on housing stability and generic quality of life among homeless adults with mental illness and moderate support needs for mental health services .


The At Home/Chez Soi project was an unblinded , randomized trial .


From October @ to July @ , participants ( N = @ ) were recruited in @ Canadian cities ( Vancouver , Winnipeg , Toronto , and Montreal ) , randomized to the intervention group ( n = @ ) or usual care group ( n = @ ) , and followed up for @ months .


The intervention consisted of scattered-site housing ( using rent supplements ) and off-site ICM services .


The usual care group had access to existing housing and support services in their communities .


The primary outcome was the percentage of days stably housed during the @-month period following randomization .


The secondary outcome was generic quality of life , assessed by a EuroQoL @ Dimensions ( EQ-@D ) health questionnaire .


During the @ months after randomization , the adjusted percentage of days stably housed was higher among the intervention group than the usual care group , although adjusted mean differences varied across sites .


-LSB- table : see text -RSB- The mean change in EQ-@D score from baseline to @ months among the intervention group was not statistically different from the usual care group ( @ -LSB- @ % CI , @ to @ -RSB- at baseline and @ -LSB- @ % CI , @ to @ -RSB- at @ months for the intervention group vs @ -LSB- @ % CI , @ to @ -RSB- at baseline and @ -LSB- @ % CI , @ to @ -RSB- at @ months for the usual care group , difference in mean changes , @ -LSB- @ % CI , @ to @ -RSB- , P = @ ) .


Among homeless adults with mental illness in @ Canadian cities , scattered site housing with ICM services compared with usual access to existing housing and community services resulted in increased housing stability over @ months , but did not improve generic quality of life .


Emerging evidence supports an association between metabolic risk factors and bone turnover .


Statins and exercise independently improve metabolic risk factors ; however whether improvements in metabolic risk factor affects bone turnover is unknown .


The purpose of the present study was to : @ ) evaluate the relationship between metabolic risk factors and bone turnover ; and @ ) determine if improvements in metabolic risk factors after @ weeks of statin treatment , exercise or the combination affect bone turnover .


Fifty participants with @ metabolic syndrome defining characteristics were randomly assigned to one of three groups : statin ( STAT : simvastatin , @ mg/day ) , exercise ( EX : brisk walking and/or slow jogging , @ minutes/day , @ days/week ) , or the combination ( STAT+EX ) .


Body composition and whole body bone mineral density were measured with dual energy X-ray absorptiometry .


Serum markers of bone formation ( bone specific alkaline phosphatase , BAP ; osteocalcin , OC ) , resorption ( C-terminal peptide of type I collagen , CTX ) and metabolic risk factors were determined .


Two-factor ( time , group ) repeated-measures ANCOVA was used to examine changes of metabolic risk factors and bone turnover .


General linear models were used to determine the effect of pre-treatment metabolic risk factors on post-treatment bone turnover marker outcomes .


Participants with @ metabolic syndrome defining characteristics had lower pre-treatment OC than those with @ or fewer .


OC was negatively correlated with glucose , and CTX was positively correlated with cholesterol .


STAT or STAT+EX lowered total and LDL cholesterol .


The OC to CTX ratio decreased in all groups with no other significant changes in bone turnover .


Higher pre-treatment insulin or body fat predicted a greater CTX reduction and a greater BAP/CTX increase .


Metabolic risk factors were negatively associated with bone turnover markers .


Short-term statin treatment with or without exercise lowered cholesterol and all treatments had a small effect on bone turnover .


There is insufficient evidence on which to base a recommendation for optimal antiplatelet therapy following a stroke while on aspirin .


The objective was to compare clopidogrel initiation vs aspirin reinitiation for vascular risk reduction among patients with ischaemic stroke on aspirin at the time of their index stroke .


Retrospective .


We conducted a nationwide cohort study by retrieving all hospitalised patients ( @ years ) with a primary diagnosis of ischaemic stroke between @ and @ from Taiwan National Health Insurance Research Database .


Among @ patients receiving aspirin before the index ischaemic stroke and receiving either aspirin or clopidogrel after index stroke during follow-up period , @ were excluded due to a medication possession ratio < @ % .


Also , @ were excluded due to history of atrial fibrillation , valvular heart disease or coagulopathy .


Therefore , @ patients were included in our final analysis .


Patients were categorised into two groups based on whether clopidogrel or aspirin was prescribed during the follow-up period .


Follow-up was from time of the index stroke to admission for recurrent stroke or myocardial infarction , death or the end of @ .


The primary end point was hospitalisation due to a new-onset major adverse cardiovascular event ( MACE : composite of any stroke or myocardial infarction ) .


The leading secondary end point was any recurrent stroke .


Compared to aspirin , clopidogrel was associated with a lower occurrence of future MACE ( HR = @ , @ % CI @ to @ , p < @ , number needed to treat : @ ) and recurrent stroke ( HR = @ , @ % CI @ to @ , p < @ , number needed to treat : @ ) after adjustment of relevant covariates .


Among patients with an ischaemic stroke while taking aspirin , clopidogrel initiation was associated with fewer recurrent vascular events than aspirin reinitiation .


Large common bile duct ( CBD ) stones remain a major challenge for endoscopists .


The capture of large CBD stones is a limiting factor for successful removal .


The aim of the study is to evaluate the efficacy and safety of stretching the basket out at the bottom of the stones to capture large CBD stones .


Sixty-five patients with large stones ( > @mm in diameter ) were selected and randomly divided into Group A ( @ cases ) and Group B ( @ cases ) .


After appropriate sphincterotomy with balloon dilation , two different methods were used to capture stones .


For Method A , the basket was inserted above a large stone and opened to capture it .


For Method B , the basket was stretched out at the bottom of the large stone and opened slowly to capture it .


The success rate of capturing stones was @ % in Group A and @ % in Group B ( P < @ ) .


There was no statistically significant difference in complication rate between the two groups ( P > @ ) .


The success rate for capturing large CBD stones can be increased by stretching the basket out at the bottom of the stones to capture the stone .


To investigate the effects of botulinum toxin type A ( BoNT-A ) injection on jaw motor episodes during sleep in patients with or without orofacial pain who did not respond to oral splint treatment .


Twenty subjects with a clinical diagnosis of SB completed this study .


Ten subjects received bilateral BoNT-A injections ( @ U per muscle ) into the masseter muscles only ( group A ) , and the other @ received the injections into both the masseter and temporalis muscles ( group B ) .


Video-polysomnographic ( vPSG ) recordings were made before and at @ weeks after injection .


Rhythmic masticatory muscle activity ( RMMA ) and orofacial activity ( OFA ) were scored and analyzed for several parameters ( e.g. , frequency of episodes , bursts per episode , episode duration ) .


The peak amplitude of electromyographic ( EMG ) activity in the two muscles was also measured .


BoNT-A injection did not reduce the frequency , number of bursts , or duration for RMMA episodes in the two groups .


The injection decreased the peak amplitude of EMG burst of RMMA episodes in the injected muscles ( p < @ , repeated measure ANOVA ) in both groups .


At @ weeks after injection , @ subjects self-reported reduction of tooth grinding and @ subjects self-reported reduction of morning jaw stiffness .


A single BoNT-A injection is an effective strategy for controlling SB for at least a month .


It reduces the intensity rather than the generation of the contraction in jaw-closing muscles .


Future investigations on the efficacy and safety in larger samples over a longer follow-up period are needed before establishing management strategies for SB with BoNT-A .


Faecal microbiota transplantation ( FMT ) from healthy donors is considered an effective treatment against recurrent Clostridium difficile infection .


To study the effect of FMT via colonoscopy in patients with recurrent C. difficile infection compared to the standard vancomycin regimen .


In an open-label , randomised clinical trial , we assigned subjects with recurrent C. difficile infection to receive : FMT , short regimen of vancomycin ( @mg four times a day for @days ) , followed by one or more infusions of faeces via colonoscopy ; or vancomycin , vancomycin @mg four times daily for @days , followed by @-@mg / day every @-@days for at least @weeks .


The latter treatment did not include performing colonoscopy .


The primary end point was the resolution of diarrhoea related to C. difficile infection @weeks after the end of treatments .


The study was stopped after a @-year interim analysis .


Eighteen of the @ patients ( @ % ) treated by FMT exhibited resolution of C. difficile-associated diarrhoea .


In FMT , five of the seven patients with pseudomembranous colitis reported a resolution of diarrhoea .


Resolution of C. difficile infection occurred in @ of the @ ( @ % ) patients in vancomycin ( P < @ ) .


No significant adverse events were observed in either of the study groups .


Faecal microbiota transplantation using colonoscopy to infuse faeces was significantly more effective than vancomycin regimen for the treatment of recurrent C. difficile infection .


The delivery of donor faeces via colonoscopy has the potential to optimise the treatment strategy in patients with pseudomembranous colitis .


In many low income countries , the delivery of quality health services is hampered by health system-wide barriers which are often interlinked , however empirical evidence on how to assess the level and scope of these barriers is scarce .


A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system .


We present the quantitative results of the @ months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting .


The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia .


The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations .


This paper reports the findings of the follow-up health facility survey that was conducted after @ months of intervention implementation .


Comparisons were made between those facilities in the intervention and control sites .


STATA version @ was used for analysis .


The study found significant mean differences between intervention ( I ) and control ( C ) sites in the following domains : Training domain ( Mean I : C ; @ .


vs @ , mean difference @ , p = @ ) , adult clinical observation domain ( mean I : C ; @ vs. @ , mean difference @ , p = @ ) and health information domain ( mean I : C ; @ vs. @ , mean difference @ , p = @ .


There was no gender differences in adult service satisfaction .


Governance and motivation scores did not differ between control and intervention sites .


This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system .


Using system wide approaches and triangulating data collection methods seems to be key to successful evaluation of such complex health intervention .


To investigate the effect of Busheng Huoxue Capsule ( BHC ) on the quality of life ( QOL ) in senile male osteoporosis ( OP ) patients , and to explore its mechanisms .


Totally @ senile primary OP patients were randomly assigned to two groups according to random digit table method , @ in each group .


Patients in the treatment group took BHC plus caltrate-D ( @ mg CaCO@ ) , while those in the control group took alendronate ( @ mg per week ) plus caltrate-D .


The therapeutic course was @ months for all .


Chinese medical symptom score and quality of life ( QUALEFFO-@ ) score , bone mineral density ( BMD ) of lumbar vertebra ( L@ - L@ ) and left femoral neck were compared between the two groups before and after treatment .


Serum free testosterone ( FT ) and estradiol ( E@ ) were also measured .


Chinese medical symptom scores and QUALEFFO-@ scores , serum FT and E@ levels increased in the two groups after treatment ( P < @ , P < @ ) .


The therapeutic effect was superior in the treatment group ( P < @ , P < @ ) .


After treatment the BMD of lumbar vertebra ( L@ - L@ ) and the left femoral neck were somewhat improved ( P < @ ) , but with no statistical difference between the two groups ( P > @ ) .


BHC could effectively improve the QOL of senile male OP patients , which might be correlated with elevating the BMD levels and regulating the levels of sex hormones .


To evaluate the clinical value of tube-sealing with norvancomycin and heparin saline mixture for prevention of central venous catheter-related infection ( CRI ) .


A prospective randomized controlled trial was performed .


@ patients who were admitted to department of critical care medicine from January @ to January @ were included , with their subclavian vein catheterization installation time longer than @ hours , age over @ years and younger than @ years , and acute physiology and chronic health evaluation II ( APACHE II ) score reaching @-@ .


The patients were divided into two groups using a random number table , and finally @ patients were enrolled .


Norvancomycin and heparin saline mixture were used for tube sealing in the intervention group ( n = @ ) , while only heparin saline was used in the control group ( n = @ ) .


The incidence of CRI , catheter correlated spectrum of pathogens , adverse events , mortality , hospital day , catheter retention time , and hospital costs were compared between two groups .


( @ ) There was no significant difference in the incidence of CRI between intervention group and control group -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , ( @ ) = @ , P = @ -RSB- .


There was no catheter pathogenic colonization in the intervention group , but there were @ cases of catheter pathogenic colonization in control group .


( @ ) A total of @ pathogens were found in two groups .


Three cases with pathogenic bacteria was found in the intervention group , with @ case of Pseudomonas aeruginosa , @ case Acinetobacter baumannii , and @ case fungi .


Staphylococcus aureus , Staphylococcus epidermidis , fungi , and Acinetobacter baumannii was found in the control group , with @ case of each .


There was no significantly statistical difference between two groups ( all P > @ ) , but there was a decreasing trend of Gram-positive cocci infection in the intervention group .


( @ ) There was no significant difference in the catheter thrombosis , local bleeding or hematoma , catheter dislocation and other adverse events between intervention group and control group -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , ( @ ) = @ , P = @ -RSB- .


( @ ) There were no significant differences in mortality -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , ( @ ) = @ , P = @ -RSB- , hospital day ( @ days vs. @ days , t = @ , P = @ ) , catheter retention time ( @ days vs. @ days , t = @ , P = @ ) and cost of hospitalization ( @ thousand Yuan : @ vs. @ , t = @ , P = @ ) between intervention group and control group .


For patients with central venous catheter , application norvancomycin with heparin saline mixture for tube sealing did not reduce the incidence of CRI , the incidence of adverse events and mortality , does not reduce hospitalization time , catheter retention time and hospital costs , but may reduce the catheter colonization and infection of Gram-positive bacteria .


Effective therapies after failure of treatment with anthracyclines and taxanes are needed for patients with metastatic breast cancer .


Dinaciclib ( MK-@ , formerly SCH@ ) , a small-molecule cyclin-dependent kinase inhibitor , has demonstrated antitumor activity in phase I studies with solid-tumor patients .


This phase II trial was designed to assess the efficacy and safety of dinaciclib compared with that of capecitabine in women with previously treated advanced breast cancer .


Patients were randomized to receive either dinaciclib at @mg/m ( @ ) , administered as a @-hour infusion every @ days , or @ mg/m ( @ ) capecitabine , administered orally twice daily in @-day cycles .


An unplanned interim analysis showed that the time to disease progression was inferior with dinaciclib treatment compared with capecitabine treatment ; therefore , the trial was stopped after @ patients were randomized .


Dinaciclib treatment demonstrated antitumor activity in @ of @ patients with estrogen receptor-positive and human epidermal growth factor receptor @-negative metastatic breast cancer ( @ confirmed and @ unconfirmed partial response ) , as well as acceptable safety and tolerability .


Grade @ or @ treatment-related adverse events were common and included neutropenia , leukopenia , increase in aspartate aminotransferase , and febrile neutropenia .


Population pharmacokinetic model-predicted mean dinaciclib exposure ( area under the concentration-time curve extrapolated to infinity -LSB- AUC -LSB- I -RSB- -RSB- ) at @ mg/m ( @ ) was similar to that observed in a previous phase I trial , and no drug accumulation was observed after multiple-dose administration .


Although dinaciclib monotherapy demonstrated some antitumor activity and was generally tolerated , efficacy was not superior to capecitabine .


Future studies may be considered to evaluate dinaciclib in select patient populations with metastatic breast cancer and in combination with other agents .


The FMP@ @ / AS@A candidate malaria vaccine was tested in a Phase @ study in Mali .


Based on results from the first eight months of follow-up , the vaccine appeared well-tolerated and immunogenic .


It had no significant efficacy based on the primary endpoint , clinical malaria , but marginal efficacy against clinical malaria in secondary analyses , and high allele-specific efficacy .


Extended follow-up was conducted to evaluate extended safety , immunogenicity and efficacy .


A randomized , double-blinded trial of safety , immunogenicity and efficacy of the candidate Plasmodium falciparum apical membrane antigen @ ( AMA@ ) vaccine FMP@ @ / AS@A was conducted in Bandiagara , Mali .


Children aged @-@ years were randomized in a @ ratio to receive FMP@ @ / AS@A or control rabies vaccine on days @ , @ and @ .


Using active and passive surveillance , clinical malaria and adverse events as well as antibodies against P. falciparum AMA@ were monitored for @ months after the first vaccination , spanning two malaria seasons .


@ children were enrolled .


Serious adverse events occurred in nine participants in the FMP@ @ / AS@A group and three in the control group ; none was considered related to study vaccination .


After two years , anti-AMA@ immune responses remained significantly higher in the FMP@ @ / AS@A group than in the control group .


For the entire @-month follow-up period , vaccine efficacy was @ % ( p = @ ) against first clinical malaria episodes and @ % ( p = @ ) against all malaria episodes .


For the final @-month follow-up period , vaccine efficacy was @ % ( p = @ ) against all malaria episodes .


Allele-specific efficacy seen in the first malaria season did not extend into the second season of follow-up .


Allele-specific vaccine efficacy was not sustained in the second malaria season , despite continued high levels of anti-AMA@ antibodies .


This study presents an opportunity to evaluate correlates of partial protection against clinical malaria that waned during the second malaria season .


Unspecified Ulcerative Rectocolitis is a chronic disease that affects between @ and @ / @ inhabitants in the world .


National and international clinical guidelines recommend the use of aminosalicylates ( including mesalazine ) as first-line therapy for induction of remission of unspecified ulcerative rectocolitis , and recommend the maintenance of these agents after remission is achieved .


However , multiple daily doses required for the maintenance of disease remission compromise compliance with treatment , which is very low ( between @ % and @ % ) .


Use of mesalazina in granules ( @ g sachet ) once daily -- Pentasa sachets @ g -- can enhance treatment adherence , reflecting in an improvement in patients ' outcomes .


To evaluate the evidence on the use of mesalazine for the maintenance of remission in patients with unspecified ulcerative rectocolitis and its effectiveness when taken once versus more than once a day .


From an economic standpoint , to analyze the impact of the adoption of this dosage in Brazil 's public health system , considering patients ' adherence to treatment .


A decision tree was developed based on the Clinical Protocol and Therapeutic Guidelines for Ulcerative Colitis , published by the Ministry of Health in the lobby SAS/MS n @ of November @ th , @ and on the algorithms published by the Associao Brasileira de Colite Ulcerativa e Doena de Crohn , aiming to get the cost-effectiveness of mesalazine once daily in granules compared with mesalazine twice daily in tablets .


The use of mesalazine increases the chances of remission induction and maintenance when compared to placebo , and higher doses are associated with greater chance of success without increasing the risk of adverse events .


The use of a single daily dose in the maintenance of remission is effective and related to higher patient compliance when compared to the multiple daily dose regimens , with lower costs .


A randomized , double-blind , active-controlled trial .


To assess the effectiveness of cervical interlaminar epidural injections of local anesthetic with or without steroids for the management of axial or discogenic pain in patients without disc herniation , radiculitis , or facet joint pain .


Cervical discogenic pain without disc herniation is a common cause of suffering and disability in the adult population .


Once conservative management has failed and facet joint pain has been excluded , cervical epidural injections may be considered as a management tool .


Despite a paucity of evidence , cervical epidural injections are one of the most commonly performed nonsurgical interventions in the management of chronic axial or disc-related neck pain .


One hundred and twenty patients without disc herniation or radiculitis and negative for facet joint pain as determined by means of controlled diagnostic medial branch blocks were randomly assigned to one of the @ treatment groups .


Group I patients received cervical interlaminar epidural injections of local anesthetic ( lidocaine @ % , @ mL ) , whereas Group II patients received @ % lidocaine , @ mL , mixed with @ mL or @ mg of nonparticulate betamethasone .


The primary outcome measure was @ % improvement in pain and function .


Outcome assessments included numeric rating scale ( NRS ) , Neck Disability Index ( NDI ) , opioid intake , employment , and changes in weight .


Significant pain relief and functional improvement ( @ % ) was present at the end of @ years in @ % of patients receiving local anesthetic only and @ % receiving local anesthetic with steroids .


In the successful group of patients , however , defined as consistent relief with @ initial injections of at least @ weeks , significant improvement was illustrated in @ % in the local anesthetic group and @ % in the local anesthetic with steroid group at the end of @ years .


The results reported at the one-year follow-up were sustained at the @-year follow-up .


Cervical interlaminar epidural injections with or without steroids may provide significant improvement in pain and functioning in patients with chronic discogenic or axial pain that is function-limiting and not related to facet joint pain .


We determined whether U-shaped relationships exist between serum lipoprotein -LSB- Lp -RSB- ( a ) and cardiometabolic risk .


In population-based nondiabetic and diabetic middle-aged adults ( n = @ and @ , respectively ) who had been genotyped for the LPA rs@ A > G polymorphism , we adjusted the Lp ( a ) concentration for the effects of genotype and other covariates .


Via sex-specific equations we estimated expected Lp ( a ) concentration in each participant , and the quotient between observed to expected Lp ( a ) values was determined .


Lp ( a ) and Lp ( a ) quotient tertiles served to identify non-linear associations with outcomes .


Incident @ cases of diabetes and @ of coronary heart disease ( CHD ) developed at @ years ' follow-up .


Lp ( a ) concentration was linearly associated with the LPA genotype , gender , total cholesterol , ( inversely ) fasting insulin , which together with age formed the variables to derive the equations .


In logistic regression for incident diabetes , the low Lp ( a ) quotient tertile was a predictor ( RR @ -LSB- @ % CI @ ; @ -RSB- ) alike the low Lp ( a ) tertile , additively to major confounders .


Cox regression models comprising sex , age , LPA genotype , smoking status , systolic pressure and serum HDL-cholesterol disclosed that , compared with the mid-tertile , both low ( HR @ ) and high Lp ( a ) quotient tertiles significantly predicted incident CHD , especially in women .


Elevated cardiometabolic risk is conferred by apparently reduced circulating Lp ( a ) assays supporting the notion that `` low '' serum Lp ( a ) , mediating autoimmune activation , is a major determinant of cardiometabolic risk .


Despite efforts to identify effective interventions to implement evidence-based practice ( EBP ) , uncertainty remains .


Few existing studies involve occupational therapists or resource-constrained contexts .


This study aimed to determine whether an interactive educational intervention ( IE ) was more effective than a didactic educational intervention ( DE ) in improving EBP knowledge , attitudes and behaviour at @ weeks .


A matched pairs design , randomised controlled trial was conducted in the Western Cape of South Africa .


Occupational therapists employed by the Department of Health were randomised using matched-pair stratification by type ( clinician or manager ) and knowledge score .


Allocation to an IE or a DE was by coin-tossing .


A self-report questionnaire ( measuring objective knowledge and subjective attitudes ) and audit checklist ( measuring objective behaviour ) were completed at baseline and @ weeks .


The primary outcome was EBP knowledge at @ weeks while secondary outcomes were attitudes and behaviour at @ weeks .


Data collection occurred at participants ' places of employment .


Audit raters were blinded , but participants and the provider could not be blinded .


Twenty-one of @ pairs reported outcomes , but due to incomplete data for two participants , @ pairs were included in the analysis .


There was a median increase of @ points ( @ % CI = -@ , @ ) in the IE for the primary outcome ( knowledge ) compared with the DE , but this difference was not significant ( P = @ ) .


There were no significant differences on any of the attitude subscale scores .


The median @-week audit score was @ points higher in the IE ( @ % CI = -@ , @ ) but this was not significant ( P = @ ) .


Within-group analyses showed significant increases in knowledge in both groups ( IE : T = @ , P < @ ; DE : T = @ , P = @ ) but no significant differences in attitudes or behaviour .


The results suggest that the interventions had similar outcomes at @ weeks and that the interactive component had little additional effect .


Neurological complications after cardiac surgery have a profound impact on postoperative survival and quality of life .


The increasing importance of strategies designed to improve neurological outcomes mirrors the growing risk burden of the contemporary cardiac surgical population .


Remote ischemic preconditioning ( RIPC ) reduces adverse sequelae of ischemia in vulnerable organs by subjecting tissues with high ischemic tolerance to brief periods of hypoperfusion .


This trial will evaluate the neuroprotective effect of RIPC in the cardiac surgical arena , by employing magnetic resonance imaging ( MRI ) and neurocognitive testing .


Patients scheduled for elective coronary artery bypass grafting with the use of cardiopulmonary bypass will be screened for the study .


Eligible patients will be randomized to undergo either a validated RIPC protocol or a sham procedure .


The RIPC will be induced by inflation of a blood pressure cuff to @ mmHg for @ minutes , followed by a @-minute reperfusion period .


Three sequences of interchanging cuff inflations and deflations will be employed .


Neurocognitive testing and MRI imaging will be performed preoperatively and on postoperative day @ .


Paired pre - and postoperative neurocognitive and neuroimaging data will then be compared .


The primary composite outcome measure will consist of new ischemic lesions on brain MRI , postprocedural impairment in brain connectivity on resting-state functional MRI ( rs-fMRI ) , and significant new declines in neurocognitive performance .


The secondary endpoint measures will be the individual components of the primary endpoint measures , expressed as continuous variables , troponin T release on postoperative day @ and the incidence of major adverse cardiovascular events at @ months postoperatively .


Major adverse cardiovascular events , including accumulating cardiovascular mortality , stroke , nonfatal myocardial infarction , and rehospitalization for ischemia , will form a composite endpoint measure .


This trial will aim to assess whether RIPC in patients subjected to surgical myocardial revascularization employing cardiopulmonary bypass initiates a neuroprotective response .


Should the results of this trial indicate that RIPC is effective in reducing the incidence of adverse neurological events in patients undergoing coronary artery bypass grafting , it could impact on the current standard of care .


To evaluate the sustaining effects of Tai Chi Qigong ( TCQ ) in improving the psychosocial health in chronic obstructive pulmonary disease ( COPD ) patients in the sixth month .


COPD affects both physical and emotional aspects of life .


Measures to minimize patients ' suffering need to be implemented .


@ COPD patients were randomly assigned into three groups : TCQ group , exercise group , and control group .


The TCQ group completed a three-month TCQ program , the exercise group practiced breathing and walking exercise , and the control group received usual care .


Significant group-by-time interactions in quality of life ( QOL ) using St. George 's respiratory questionnaire ( P = @ ) and the perceived social support from friends using multidimensional scale of perceived social support ( P = @ ) were noted .


Improvements were observed in the TCQ group only .


TCQ has sustaining effects in improving psychosocial health ; it is also a useful and appropriate exercise for COPD patients .


Recent data suggest that chronic low-grade inflammation , a characteristic of obesity , is associated with altered tryptophan ( Trp ) and tyrosine ( Tyr ) metabolism and plays a role in neuropsychiatric symptoms .


The present study assessed the effect of an extreme short-term diet on Trp breakdown and inflammatory biomarkers in overweight adults .


Thirty-eight overweight participants ( @ women , @ men ; average body mass index : @ kg/m , mean age @ years ) were randomized into two diet groups : a very low kcal diet group ( VLCD ; @ kcal/day , n = @ ) and a low kcal diet group ( LCD ; @,@ kcal/day , n = @ ) .


Assays included the measurement of Trp , kynurenine ( Kyn ) , and their ratio , neopterin , phenylalanine ( Phe ) , Tyr , as biologic markers ; leptin , plasma insulin , glucose , and homeostatic model assessment-insulin resistance ; and interleukin @ , tumor necrosis factor alpha , and C-reactive protein , as biochemical and inflammatory markers at baseline and after @ weeks of treatment .


Weight loss diet lowered leptin levels in both groups by @ % , although not reaching significance .


Trp and Kyn decreased significantly by @ and @ % for VLCD and by @ and @ % for the LCD group , respectively .


A significant reduction in Phe was only seen after VLCD .


Inflammatory biomarkers , neopterin , and Tyr were not significantly altered during the study period .


Leptin was significantly correlated with Trp breakdown before and after the intervention ( P < @ ) .


Since disturbed metabolism of Trp affects biosynthesis of serotonin and might be associated with increased susceptibility for mood disturbances and carbohydrate craving , strategies to supplement Trp while dieting could be highly useful in treating uncontrolled weight gain or in preventing neuropsychiatric symptoms .


To determine in patients with normal ejection fraction , undergoing permanent VVI pacing , if medial septal stimulation has lower dyssynchrony than apical stimulation assessed by echocardiography .


A prospective trial , @ patients > @ years old , scheduled for VVI pacemaker implantation for complete degenerative atrioventricular block , ventricular frequency < @beat per minute and ejection fraction@ % .


Patients with atrial fibrillation , heart failure , left bundle branch block and QRS durations longer than @milliseconds in surface electrocardiogram with sinus rhythm were excluded .


Patients were randomized to apical implantation group A : @ % and septal implantation group B : @ % .


Echocardiographic parameters were measured previous to the implant , @h , @ and @ months after implantation .


No patients had diagnosis of ischemic cardiomyopathy or heart failure .


Echocardiographic parameters for interventricular dyssynchrony between groups were A : @ msec vs. B : @ msec ; A : @ msec vs. B : @ msec ; A : @ msec vs. B : @ msec , P = NS ) .


For interventricular dyssynchrony were A : @ msec vs. B : @ msec ; A : @ msec vs. B : @ msec ; A : @,@ msec vs. B : @ msec , P = NS ) at @h , @ and @ months , respectively .


Apical site of stimulation does not increase ventricular dyssynchrony rate in patients with preserved ejection fraction .


Septal stimulation showed decreased trend in interventricular dyssynchrony .


Cancer is the leading cause of death among Asian Americans .


While Asian Americans are the fastest growing minority population in the United States , they are underrepresented in cancer research and report poor adherence to cancer screening guidelines .


This study utilized data from two large randomized intervention trials to evaluate strategies to recruit first-generation Chinese American immigrants from community settings and Chinese American physician practices .


Findings will inform effective strategies for promoting Asian American participation in cancer control research .


Chinese Americans who were non-adherent to annual mammography screening guidelines ( Study @ with @ immigrant women > @ years of age ) and to colorectal cancer screening guidelines ( Study @ with @ immigrants > @ years of age ) were enrolled from the greater Washington DC , New York City ( NYC ) , and Philadelphia ( PA ) areas .


Both studies trained bilingual staff to enroll Chinese-speaking participants with the aid of linguistically appropriate fliers and brochures to obtain consent .


Study @ adopted community approaches and worked with community organizations to enroll participants .


Study @ randomly selected potential participants through @ Chinese American primary-care physician offices , and mailed letters from physicians to enroll patients , followed by telephone calls from research staff .


The success of recruitment approaches was assessed by yield rates based on number of participants approached , ineligible , and consented .


Most participants ( @ % ) of Study @ were enrolled through in-person community approaches ( e.g. , Chinese schools , stores , health fairs , and personal networks ) .


The final yield of specific venues differed widely ( @ % to @ % ) due to various proportions of ineligible subjects ( @ % -@ % ) and refusals ( @ % -@ % ) .


The Study @ recruitment approach ( physician letter followed by telephone calls ) had different outcomes in two geographic areas , partially due to differences in demographic characteristics in the DC and NYC/PA areas .


The community approaches enrolled more recent immigrants and uninsured Chinese Americans than the physician and telephone call approach ( p < @ ) .


Enrollment cost is provided to inform future research studies .


Our recruitment outcomes might not be generalizable to all Chinese Americans or other Asian American populations because they may vary by study protocols ( e.g. , length of trials ) , target populations ( i.e. , eligibility criteria ) , and available resources .


Use of multiple culturally relevant strategies ( e.g. , building trusting relationships through face-to-face enrollment , use of bilingual and bicultural staff , use of a physician letter , and employing linguistically appropriate materials ) was crucial for successfully recruiting a large number of Chinese Americans in community and clinical settings .


Our data demonstrate that substantial effort is required for recruitment ; studies need to budget for this effort to ensure the inclusion of Asian Americans in health research .


Cognitive behavior therapy ( CBT ) has been established as efficacious for obsessive-compulsive disorder ( OCD ) among older children and adolescents , yet its effect on young children has not been evaluated sufficiently .


To examine the relative efficacy of family-based CBT ( FB-CBT ) involving exposure plus response prevention vs an FB relaxation treatment ( FB-RT ) control condition for children @ to @ years of age .


A @-week randomized clinical trial ( Pediatric Obsessive-Compulsive Disorder Treatment Study for Young Children -LSB- POTS Jr -RSB- ) conducted at @ academic medical centers between @ and @ , involving @ pediatric outpatients @ to @ years of age who received a primary diagnosis of OCD and a Children 's Yale-Brown Obsessive Compulsive Scale total score of @ or higher .


Participants were randomly assigned to @ weeks of ( @ ) FB-CBT , including exposure plus response prevention , or ( @ ) FB-RT .


Responder status defined as an independent evaluator-rated Clinical Global Impression-Improvement scale score of @ ( very much improved ) or @ ( much improved ) and change in independent evaluator-rated continuous Children 's Yale-Brown Obsessive Compulsive Scale total score .


RESULTS Family-based CBT was superior to FB-RT on both primary outcome measures .


The percentages of children who were rated as @ ( very much improved ) or @ ( much improved ) on the Clinical Global Impression-Improvement scale at @ weeks were @ % for FB-CBT and @ % for FB-RT .


The effect size difference between FB-CBT and FB-RT on the Clinical Global Impression-Improvement scale was @ ( @ % CI , @-@ @ ) .


The number needed to treat ( NNT ) with FB-CBT vs FB-RT was estimated as @ ( @ % CI , @-@ @ ) .


The effect size difference between FB-CBT and FB-RT on the Children 's Yale-Brown Obsessive Compulsive Scale at week @ was @ ( @ % CI , @-@ @ ) .


A comprehensive FB-CBT program was superior to a relaxation program with a similar format in reducing OCD symptoms and functional impairment in young children ( @-@ years of age ) with OCD .


Human infections with the avian influenza A ( H@N@ ) virus were first reported in China in @ and continue to occur .


Hemagglutinin H@ administered alone is a poor immunogen necessitating evaluation of adjuvanted H@N@ vaccines .


To evaluate the immunogenicity and safety of an inactivated H@N@ vaccine with and without AS@ adjuvant , as well as mixed vaccine schedules that included sequential administration of AS@ - and MF@-containing formulations and of adjuvanted and unadjuvanted formulations .


Double-blind , phase @ trial at @ US sites enrolled @ adults aged @ through @ years from September @ through November @ ; safety follow-up was completed in January @ .


The H@N@ vaccine was given on days @ and @ at nominal doses of @ g , @ g , @ g , and @ g of hemagglutinin with or without AS@ or MF@ adjuvant mixed on site .


Proportions achieving a hemagglutination inhibition antibody ( HIA ) titer of @ or higher at @ days after the second vaccination ; vaccine-related serious adverse events through @ months after the first vaccination ; and solicited signs and symptoms after vaccination through day @ .


Two doses of vaccine were required to induce detectable antibody titers in most participants .


After @ doses of an H@N@ formulation containing @ g of hemagglutinin given without adjuvant , with AS@ adjuvant , or with MF@ adjuvant , the proportion achieving an HIA titer of @ or higher was @ % ( @ % CI , @ % -@ % ) without adjuvant ( n = @ ) , @ % ( @ % CI , @ % -@ % ) with AS@ adjuvant ( n = @ ) , and @ % ( @ % CI , @ % -@ % ) with MF@ adjuvant ( n = @ ) ( P < @ for comparison of the AS@ and MF@ schedules ) .


The @ schedules alternating AS@-and MF@-adjuvanted formulations led to lower geometric mean titers ( GMTs ) of ( @ -LSB- @ % CI , @-@ @ -RSB- ; n = @ ) and ( @ -LSB- @ % CI , @-@ @ -RSB- ; n = @ ) than the group induced by @ AS@-adjuvanted formulations ( n = @ ) ( @ -LSB- @ % CI , @-@ @ -RSB- ; P < @ ) but higher GMTs than @ doses of MF@-adjuvanted formulation ( n = @ ) ( @ -LSB- @ % CI , @-@ @ -RSB- ; P < @ ) .


The AS@ and MF@ adjuvants augmented the immune responses to @ doses of an inactivated H@N@ influenza vaccine , with AS@-adjuvanted formulations inducing the highest titers .


This study of @ adjuvants used in influenza vaccine formulations with adjuvant mixed on site provides immunogenicity information that may be informative to influenza pandemic preparedness programs .


To assess the effect of red blood cell ( RBC ) transfusion on quality of life in acutely anaemic women after postpartum haemorrhage .


Randomised non-inferiority trial .


Thirty-seven Dutch university and general hospitals .


Women with acute anaemia ( haemoglobin @-@ @ g/dl -LSB- @-@ @ mmol/l -RSB- @-@ hours postpartum ) without severe anaemic symptoms or severe comorbidities .


Women were allocated to RBC transfusion or non-intervention .


Primary outcome was physical fatigue @ days postpartum ( Multidimensional Fatigue Inventory , scale @-@ ; @ represents maximal fatigue ) .


Non-inferiority was demonstrated if the physical fatigue difference between study arms was maximal @ .


Secondary outcomes were health-related quality of life and physical complications .


Health-related quality of life questionnaires were completed at five time-points until @ weeks postpartum .


In all , @ women were randomised to non-intervention ( n = @ ) or RBC transfusion ( n = @ ) .


Mean physical fatigue score at day @ postpartum , adjusted for baseline and mode of delivery , was @ lower in the RBC transfusion arm ( @ % confidence interval : @-@ @ , P = @ ) and at @ week postpartum was @ lower ( @ % confidence interval : @-@ @ , P = @ ) .


A median of two RBC units was transfused in the RBC transfusion arm .


In the non-intervention arm , @ women received RBC transfusion , mainly because of anaemic symptoms .


Physical complications were comparable .


Statistically , non-inferiority could not be demonstrated as the confidence interval crossed the non-inferiority boundary .


Nevertheless , with only a small difference in physical fatigue and no differences in secondary outcomes , implementation of restrictive management seems clinically justified .


The purpose of this randomized double-blinded clinical trial was to test the efficacy and tooth sensitivity promoted by the use of an in-office @ % H ( @ ) O ( @ ) bleaching agent containing nanoparticles of TiO_N photocatalyzed with LED/laser light ( HP@ ) and a control of @ % H@O@ ( HP@ ) .


Forty healthy volunteers , both sexes , aged @ to @ yr , were randomly distributed in @ groups : HP@ ( n = @ ) was treated in @ sessions of @ min each , and HP@ ( n = @ ) was treated in @ sessions of @ min each .


The efficacy ( E ) was evaluated by E values measured via reflectance spectroscopy .


The tooth sensitivity ( S ) was analyzed by visual analog scale ( low , average , high , very high ) .


The absolute risk reduction and the number needed to treat index were calculated .


The data were analyzed by mixed repeated measures analysis of variance with Bonferroni-correction t test ( = @ ) .


For the efficacy , significant differences were found for number of bleaching sessions ( p = @ ; -LSB- Formula : see text -RSB- = @ and = @ ) and for the interaction of number of sessions and bleaching protocols ( p = @ ; -LSB- Formula : see text -RSB- = @ and = @ .


The tooth sensitivity level showed significant differences only between the bleaching protocols .


Absolute risk reduction calculated was @ % and number needed to treat , @ .


The bleaching agent with the lower concentration ( HP@ ) promoted lower levels of tooth sensitivity and presented greater efficacy compared to the control ( HP@ ) in patients between @ and @ yr old .


The limitation of short-term evaluation did not provide information about the longevity of the tooth bleaching ( Brazilian Clinical Trials Registry Re Bec no .


U@-@-@ ) .


Dysregulation of the hepatocyte growth factor ( HGF ) / MET pathway promotes tumour growth and metastasis .


Rilotumumab is a fully human , monoclonal antibody that neutralises HGF .


We aimed to assess the safety , efficacy , biomarkers , and pharmacokinetics of rilotumumab combined with epirubicin , cisplatin , and capecitabine ( ECX ) in patients with advanced gastric or oesophagogastric junction cancer .


We recruited patients ( @ years old ) with unresectable locally advanced or metastatic gastric or oesophagogastric junction adenocarcinoma , an Eastern Cooperative Oncology Group ( ECOG ) performance status of @ or @ , who had not received previous systemic therapy , from @ sites worldwide .


Phase @b was an open-label , dose de-escalation study to identify a safe dose of rilotumumab ( initial dose @ mg/kg intravenously on day @ ) plus ECX ( epirubicin @ mg/m ( @ ) intravenously on day @ , cisplatin @ mg/m ( @ ) intravenously on day @ , capecitabine @ mg/m ( @ ) twice a day orally on days @-@ , respectively ) , administered every @ weeks .


The phase @b primary endpoint was the incidence of dose-limiting toxicities in all phase @b patients who received at least one dose of rilotumumab and completed the dose-limiting toxicity assessment window ( first cycle of therapy ) .


Phase @ was a double-blind study that randomly assigned patients ( @:@:@ ) using an interactive voice response system to receive rilotumumab @ mg/kg , rilotumumab @ mg/kg , or placebo , plus ECX ( doses as above ) , stratified by ECOG performance status and disease extent .


The phase @ primary endpoint was progression-free survival ( PFS ) , analysed by intention to treat .


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


Seven of the nine patients enrolled in the phase @b study received at least one dose of rilotumumab @ mg/kg , only two of whom had three dose-limiting toxicities : palmar-plantar erythrodysesthesia , cerebral ischaemia , and deep-vein thrombosis .


In phase @ , @ patients were randomly assigned ( @ to rilotumumab @ mg/kg ; @ to rilotumumab @ mg/kg ; @ to placebo ) .


Median PFS was @ months ( @ % CI @-@ ) in the rilotumumab @ mg/kg group , @ months ( @-@ ) in the rilotumumab @ mg/kg group , @ months ( @-@ ) in both rilotumumab groups combined , and @ months ( @-@ ) in the placebo group .


The hazard ratio for PFS events compared with placebo was @ ( @ % CI @-@ ; p = @ ) for rilotumumab @ mg/kg , @ ( @ % CI @-@ ; p = @ ) for rilotumumab @ mg/kg , and @ ( @ % CI @-@ ; p = @ ) for combined rilotumumab .


Any grade adverse events more common in the combined rilotumumab group than in the placebo group included haematological adverse events ( neutropenia in @ -LSB- @ % -RSB- of @ patients vs @ -LSB- @ % -RSB- of @ patients ; anaemia in @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; and thrombocytopenia in nine -LSB- @ % -RSB- vs none ) , peripheral oedema ( @ -LSB- @ % -RSB- vs three -LSB- @ % -RSB- ) , and venous thromboembolism ( @ -LSB- @ % -RSB- vs five -LSB- @ % -RSB- ) .


Grade @-@ adverse events more common with rilotumumab included neutropenia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) and venous thromboembolism ( @ -LSB- @ % -RSB- vs four -LSB- @ % -RSB- ) .


Serious adverse events were balanced between groups except for anaemia , which occurred more frequently in the combined rilotumumab group ( ten -LSB- @ % -RSB- vs none ) .


Rilotumumab plus ECX had no unexpected safety signals and showed greater activity than placebo plus ECX .


A phase @ study of the combination in MET-positive gastric and oesophagogastric junction cancer is in progress .


Laser therapies have been Food and Drug Administration approved for temporary nail plate clearance ; however , there is minimal evidence of their long-term efficacy .


We sought to evaluate the clinical and mycological clearance of toenails treated with @-nm neodymium : yttrium-aluminum-garnet laser versus no treatment .


This was a randomized , controlled , single-center trial comparing @ treatments with @-nm neodymium : yttrium-aluminum-garnet laser ( fluence of @ J/cm ( @ ) , rate of @ Hz ) spaced @ weeks apart versus no treatment in @ patients ( N = @ affected nails ) with clinical and mycological diagnosis of onychomycosis .


At @ months , patients were assessed with mycological cultures and proximal nail plate measurements .


Patients treated with laser were also assessed with proximal nail plate measurements at @ months .


At @ months , @ % of patients treated with laser achieved a negative mycological culture compared with @ % of the control group ( P = @ ) , and had more proximal nail plate clearance compared with control subjects ( @ vs @ mm , P = @ ) , which was not statistically significant .


At @ months , there was no difference in nail plate clearance between laser versus control subjects ( @ vs @ mm , P = @ ) .


Our study was limited by the small sample size and number of treatments .


There was no significant mycological culture or clinical nail plate clearance with @-nm neodymium : yttrium-aluminum-garnet laser compared with control .


To evaluate effects of various doses of polyethylene glycol ( PEG ) - conjugated bovine granulocyte colony-stimulating factor ( bG-CSF ) on the incidence of naturally occurring clinical mastitis in periparturient dairy cattle .


@ periparturient Holstein cows and heifers .


Approximately @ days before the anticipated date of parturition ( day of parturition = day @ ) , healthy cattle received SC injections of sterile saline ( @ % NaCl ) solution ( control treatment ) or PEG-bG-CSF at @ , @ , or @ g/kg .


Cattle were commingled and housed in a pen with dirt flooring , which was kept wet to maximize the incidence of naturally occurring clinical mastitis .


Within @ hours after parturition , each animal again received the assigned treatment .


Mammary glands and milk were visually scored for abnormalities twice daily for @ days after parturition .


Milk samples were aseptically collected from mammary glands with an abnormal appearance or abnormal milk and submitted for microbial culture .


Daily milk production was recorded , and milk composition was assessed on days @ , @ , @ , and @ .


Cattle treated with PEG-bG-CSF at @ and @ g/kg had significantly fewer cases of clinical mastitis ( @/@ and @/@ , respectively ) , compared with control cattle ( @/@ ) .


Administration of PEG - bG-CSF did not significantly affect daily milk production or milk composition .


Results suggested that PEG-bG-CSF was effective for reducing the incidence of naturally occurring clinical mastitis in periparturient dairy cattle .


Further investigations of the use of PEG-bG-CSF as a potential preventative intervention should be conducted .


Patients with progressive disease after two or more HER@-directed regimens for recurrent or metastatic breast cancer have few effective therapeutic options .


We aimed to compare trastuzumab emtansine , an antibody-drug conjugate comprising the cytotoxic agent DM@ linked to trastuzumab , with treatment of physician 's choice in this population of patients .


This randomised , open-label , phase @ trial took place in medical centres in @ countries across Europe , North America , South America , and Asia-Pacific .


Eligible patients ( @ years , left ventricular ejection fraction @ % , Eastern Cooperative Oncology Group performance status @-@ ) with progressive HER@-positive advanced breast cancer who had received two or more HER@-directed regimens in the advanced setting , including trastuzumab and lapatinib , and previous taxane therapy in any setting , were randomly assigned ( in a @:@ ratio ) to trastuzumab emtansine ( @ mg/kg intravenously every @ days ) or physician 's choice using a permuted block randomisation scheme by an interactive voice and web response system .


Patients were stratified according to world region ( USA vs western Europe vs other ) , number of previous regimens ( excluding single-agent hormonal therapy ) for the treatment of advanced disease ( two to three vs more than three ) , and presence of visceral disease ( any vs none ) .


Coprimary endpoints were investigator-assessed progression-free survival ( PFS ) and overall survival in the intention-to-treat population .


We report the final PFS analysis and the first interim overall survival analysis .


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


From Sept @ , @ , to Nov @ , @ , @ patients were randomly assigned ( @ to trastuzumab emtansine and @ to physician 's choice ) .


At data cutoff ( Feb @ , @ ) , @ patients assigned to physician 's choice had crossed over to trastuzumab emtansine .


After a median follow-up of @ months ( IQR @-@ months ) in the trastuzumab emtansine group and @ months ( IQR @-@ ) in the physician 's choice group , @ ( @ % ) patients in the trastuzumab emtansine group and @ ( @ % ) of patients in the physician 's choice group had PFS events .


PFS was significantly improved with trastuzumab emtansine compared with physician 's choice ( median @ months -LSB- @ % CI @-@ -RSB- vs @ months -LSB- @-@ -RSB- ; stratified hazard ratio -LSB- HR -RSB- @ -LSB- @-@ -RSB- ; p < @ ) .


Interim overall survival analysis showed a trend favouring trastuzumab emtansine ( stratified HR @ -LSB- @ % CI @-@ -RSB- ; p = @ ) , but the stopping boundary was not crossed .


A lower incidence of grade @ or worse adverse events was reported with trastuzumab emtansine than with physician 's choice ( @ events -LSB- @ % -RSB- in @ patients vs @ events -LSB- @ % -RSB- in @ patients ) .


Neutropenia ( ten -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , diarrhoea ( three -LSB- < @ % -RSB- vs eight -LSB- @ % -RSB- ) , and febrile neutropenia ( one -LSB- < @ % -RSB- vs seven -LSB- @ % -RSB- ) were grade @ or worse adverse events that were more common in the physician 's choice group than in the trastuzumab emtansine group .


Thrombocytopenia ( @ -LSB- @ % -RSB- vs three -LSB- @ % -RSB- ) was the grade @ or worse adverse event that was more common in the trastuzumab emtansine group .


@ ( @ % ) patients in the trastuzumab emtansine group and @ ( @ % ) in the physician 's choice group reported a serious adverse event .


Trastuzumab emtansine should be considered as a new standard for patients with HER@-positive advanced breast cancer who have previously received trastuzumab and lapatinib .


Because inactivated trivalent influenza vaccines ( TIVs ) contain @ influenza B strain , whereas @ lineages may co-circulate , B lineage mismatch is frequent .


We assessed an inactivated quadrivalent influenza vaccine ( QIV ) containing both B lineages versus TIV in young children .


Children aged @-@ months who had received @ doses of TIV in a study during the previous season ( primed cohort , n = @ ) were randomized @:@ to receive @ dose of TIV or QIV , and a further @ children ( unprimed cohort ) were randomized @:@ to receive @ doses of TIV or QIV @ days apart .


Immunogenicity was assessed by hemagglutination-inhibition ( HI ) prevaccination and @ days after each vaccination .


Immunogenic non-inferiority QIV versus TIV for shared strains , and superiority against the alternate-lineage B strain were based on HI geometric mean titers ( pooled analyses of primed and half of unprimed cohort with Day @ immunogenicity assessment ) .


Solicited and unsolicited adverse events were assessed during each @ - and @-day postvaccination period , respectively ( NCT@ ) .


Non-inferiority for shared strains and superiority for the alternate-lineage B strain unique to QIV was demonstrated for QIV versus TIV .


QIV was immunogenic against all @ vaccine strains and @ % , @ % , @ % and @ % of children had postvaccination titers of @:@ against A/H@N@ , A/H@N@ , B/Victoria and B/Yamagata , respectively .


Reactogenicity and safety of QIV was consistent with TIV .


QIV provided superior immunogenicity for the alternate-lineage B strain compared with TIV without interfering with immune responses to shared strains .


Further studies are warranted to assess QIVs in children and to establish the clinical benefits of QIV versus TIV .


Succinylcholine provides rapid onset of neuromuscular blockade and short duration of action , but its administration may be associated with hyperkalemia .


Rocuronium is not known to increase potassium concentration , has fast onset of activity , and can be rapidly reversed by sugammadex .


This study evaluated changes in plasma potassium concentrations in patients randomized either to rocuronium followed by sugammadex reversal or to succinylcholine in ambulatory surgery .


In this multicentre randomized active-controlled study , adult patients undergoing short surgical procedures in an outpatient setting received either rocuronium @ mgkg ( -@ ) for intubation with sugammadex @ mgkg ( -@ ) for reversal ( n = @ ) or succinylcholine @ mgkg ( -@ ) with spontaneous recovery ( n = @ ) .


Blood potassium concentrations were assessed at baseline ( before study drug administration ) and at intervals up to @min after rocuronium , sugammadex , and succinylcholine .


At the primary endpoint , five minutes post-administration , the changes in potassium concentrations from baseline were significantly smaller in patients treated with rocuronium than in those given succinylcholine -LSB- mean ( SD ) : -@ ( @ ) vs @ ( @ ) mmolL ( -@ ) , respectively ; P < @ -RSB- .


At baseline , potassium concentrations were similar in both groups , but they were greater at two , five , ten , and @min after succinylcholine than after rocuronium ( P < @ ) for all time points .


After sugammadex administration , there were no significant changes in mean potassium concentration from the pre-rocuronium baseline .


No adverse effects related to hyperkalemia were observed .


Succinylcholine was associated with a modest increase in potassium concentration ; these changes were not seen after rocuronium or sugammadex (


Intrathecal morphine is used for post-cesarean analgesia , but pruritus is a common side effect .


Ondansetron would be an attractive treatment because it prevents nausea , is non-sedative or has no anti-analgesic effect .


We undertook a study to assess the efficacy of ondansetron for treatment or prophylaxis of intrathecal morphine-induced pruritus .


Healthy paturients undergoing cesarean delivery with intrathecal morphine @g and fentanyl @g were randomized to receive : prophylaxis ( ondansetron @mg at cord clamping , normal saline @mL for treatment of pruritus in the post-anaesthesia care unit ) ; treatment ( normal saline @mL at cord clamping , ondansetron @mg as required in the post-anesthesia care unit ) or control ( normal saline @mL in both ) .


Visual analogue scale scores for pruritus , nausea and pain were recorded preoperatively , on arrival to , at @ , @ , and @min and on discharge from the post-anesthesia care unit .


The primary outcome was the peak pruritus score .


ANOVA with Bonferroni correction or Fisher 's exact test were used to analyze data ; P < @ was considered significant .


The study was terminated early when interim analysis indicated no effect .


Eighty-two of the intended @ paturients completed the protocol ( @ in control group , @ in treatment group and @ in prophylaxis ) .


There were no differences in the rate or severity of pruritus at any assessment point , or the request for treatment .


Pruritus was reduced after administration of treatment syringe .


Prophylactic ondansetron did not reduce pruritus when compared with placebo .


The use of ondansetron as a treatment did not decrease the severity of pruritus when compared with placebo .


An important biological factor suggested in the pathophysiology of ( recurrent ) Major Depressive Disorder ( MDD ) concerns a polymorphism in a gene encoding for the MTHFR-enzyme of the one-carbon ( @-C ) - metabolism .


Integratively investigating key @-C-components ( folate , homocysteine , vitamin B@ and B@ ) , including the possible effects of antidepressant medication and depressive state , could provide more insight in the possible association between the MTHFR-polymorphism and recurrent MDD .


We compared the MTHFR C@T-polymorphism together with the key @-C-components in clinically ascertained patients with recurrent MDD ( n = @ ) to age - and gender-matched healthy controls ( n = @ ) .


First , patients had lower folate ( t = @ ; p = @ ) as compared to controls ; a difference that resolved after correction for demographics ( t = @ ; p = @ ) .


Second , patients that were depressed during sampling had lower vitamin B@ ( t = -@ ; p = @ ) and higher homocysteine ( t = @ ; p = @ ) compared to those in remission .


Finally , current use of antidepressants had no influence on the @-C-components .


Despite investigation of a specific recurrently depressed patient population , we found no clear associations with the @-C-cycle , except for higher homocysteine and lower vitamin B@ during the depressed state .


This suggests that @-C-cycle alterations in MDD are state-associated , possibly resulting from high levels of acute ( psychological ) stress , and may provide a treatment target to reduce cardiovascular risk in this population .


Although hepatitis delta is considered an immune-mediated disease , adaptive immune responses to hepatitis delta virus ( HDV ) are hardly detectable .


Thus , the role of other immune responses , including those mediated by natural killer ( NK ) cells , must be considered in HDV pathogenesis and in treatments with immune-stimulating agents such as interferon ( IFN ) .


However , the phenotype and function of NK cells in chronic HDV infection , or in HDV-infected individuals undergoing IFN treatment , have not been extensively studied .


We performed an extensive analysis of NK cells in chronically HDV-infected patients before and during treatment with IFN , and compared the results with those for patients with HBV mono-infection as well as healthy controls .


In untreated HDV-infected patients , a higher than normal frequency of NK cells was observed in peripheral blood with unaltered phenotypic NK cell differentiation status .


In contrast , long-term IFN treatment of HDV-infected patients caused a significant change in NK cell differentiation status , with selective loss of terminally differentiated NK cells and , in parallel , a relative enrichment in immature NK cell subsets .


Treatment was associated with marked functional impairment of the NK cells , which was independent of the changes in NK cell differentiation status .


Furthermore , treatment polarised NK cell IFN signalling from STAT@ towards STAT@ dependency .


Strikingly , a high frequency of CD@ ( dim ) NK cells at baseline was positively associated with IFN treatment outcome in the patients .


We describe in detail how HDV infection , and IFN treatment of this infection , affects the NK cell compartment and what consequences this has for the functional capacity of NK cells .


To study the effects of erythropoietin ( EPO ) on serum levels of neuron-specific enolase ( NSE ) and S-@B in neonates with hypoxic-ischemic encephalopathy ( HIE ) and the underlying mechanism .


Forty neonates with HIE were randomly divided into conventional treatment ( n = @ ) and EPO treatment groups ( n = @ ) .


Twenty healthy full-term neonates born during the same period were randomly selected as the normal control group .


The conventional treatment group received conventional treatment , while the EPO treatment group received conventional treatment as well as EPO -LSB- @ IU / ( kg.d ) -RSB- which was given by intravenous infusion from the second day after birth .


The course of treatment was @ days .


Blood samples of the three groups were collected on the first day after birth ( before treatment ) and the ninth day after birth ( after treatment ) .


Serum levels of NSE and S-@B were measured by double-antibody sandwich ABC-ELISA .


Before treatment , the two treatment groups had significantly higher serum NSE and S-@B levels than the normal control group ( P < @ ) , whereas no significant differences in the levels of NSE and S-@B were observed between the conventional treatment and EPO treatment groups ( P > @ ) .


The serum NSE and S-@B levels on the ninth day after birth were significantly lower than those on the first day after birth in the three groups ( P < @ ) .


After treatment , the serum NSE and S-@B levels were significantly lower in the EPO treatment group than in the conventional treatment group ( P < @ ) .


Dynamic monitoring of serum NSE and S-@B levels may be helpful for the early diagnosis of HIE and the assessment of brain injury repair in newborns with HIE .


EPO may be helpful for the repair of neurons and glial cells .


The aim of this study was to examine the relationship between quality of life ( QoL ) , weight , and eating disorder symptoms across treatment in individuals with severe and enduring anorexia nervosa ( SE-AN ) .


Participants were @ adult females with SE-AN presenting to an outpatient , multisite randomized clinical trial .


QoL was assessed using three well-validated QoL questionnaire measures , the EDQOL , SF-@ , and WSAS .


Participants ' weight and severity of symptoms was assessed by Eating Disorder Examination ( EDE ) and weekly BMI change .


Predictors of QoL were evaluated in the context of concurrent , prospective ,@ and lagged mixed-effects models .


Changes in both BMI and EDE were found to significantly affect current and future QoL ratings .


Findings suggest that improvements in QoL may be dependent on symptom change and weight gain .


Treatments seeking solely to improve QoL may be unlikely to produce lasting change and clinicians should maintain a focus on weight and behavioral symptoms as much as on improvements in QoL .


To compare iron depletion to lifestyle changes alone in patients with severe nonalcoholic fatty liver disease ( NAFLD ) and hyperferritinemia , a frequent feature associated with more severe liver damage , despite at least @ mo of lifestyle changes .


Eligible subjects had to be @-@ years old who underwent liver biopsy for ultrasonographically detected liver steatosis and hyperferritinemia , ferritin levels @ ng/mL , and NAFLD activity score > @ .