Intervention schools should endeavor to ensure that students were physically active for at least @ min every school day .


Cognitive function was measured by a modified Eriksen flanker task and academic skills by a custom made mathematics test .


PA was objectively measured by accelerometers ( ActiGraph , GT@X and GT@X + ) and aerobic fitness assessed by an intermittent shuttle-run test ( the Andersen intermittent running test ) .


Furthermore , compliance with the intervention was assessed by short message service ( SMS ) - tracking and questionnaires were delivered to students , parents and teachers .


LCoMotion has ability to provide new insights on the effectiveness of a multicomponent intervention on cognitive function and academic skills in @th and @th grade students .


Medication treatment decisions in heart failure ( HF ) are currently informed by measurements of brachial artery pressure , but ventricular afterload is more accurately represented by central aortic pressure , which differs from brachial pressure .


We sought to determine whether aggressive titration of vasoactive medicines beyond goal-directed heart failure medical therapy ( GDMT ) based upon aortic pressure improves exercise capacity and cardiovascular structure-function .


Subjects with chronic HF ( n = @ ) underwent cardiopulmonary exercise testing , echocardiography , and arterial tonometry to measure aortic pressure and augmentation index , and were then randomized to aortic pressure-guided treatment ( active , n = @ ) or conventional therapy ( control , n = @ ) .


Subjects returned for @ monthly visits wherein GDMT was first optimized .


Additional vasoactive therapies were then sequentially added with the goal to reduce aortic augmentation index to @ % ( active ) or if brachial pressure remained elevated ( control ) .


Subjects randomized to active treatment experienced greater improvement in peak oxygen consumption compared with controls ( @ versus -@ mL min ( -@ ) kg ( -@ ) , P = @ ) though reductions in aortic augmentation index were similar ( -@ % versus -@ % , P = @ ) .


Forward stroke volume increased while arterial elastance and left ventricular volumes decreased in all participants , with no between-group difference .


Subjects randomized to active treatment were more likely to receive additional vasoactive therapies including nitrates , aldosterone antagonists and hydralazine , with no increased risk of hypotension or worsening renal function .


Maximization of goal-directed medical therapy in heart failure patients may enhance afterload reduction and lead to reverse remodeling , while additional medicine titration based upon aortic pressure data improves exercise capacity in patients with heart failure .


Haemorrhage is a common cause of death in trauma patients .


Although transfusions are extensively used in the care of bleeding trauma patients , there is uncertainty about the balance of risks and benefits and how this balance depends on the baseline risk of death .


Our objective was to evaluate the association of red blood cell ( RBC ) transfusion with mortality according to the predicted risk of death .


A secondary analysis of the CRASH-@ trial ( which originally evaluated the effect of tranexamic acid on mortality in trauma patients ) was conducted .


The trial included @,@ trauma patients with significant bleeding from @ hospitals in @ countries .


We evaluated the association of RBC transfusion with mortality in four strata of predicted risk of death : < @ % , @ % -@ % , @ % -@ % , and > @ % .


For this analysis the exposure considered was RBC transfusion , and the main outcome was death from all causes at @ days .


A total of @,@ patients ( @ % ) received at least one transfusion .


We found strong evidence that the association of transfusion with all-cause mortality varied according to the predicted risk of death ( p-value for interaction < @ ) .


Transfusion was associated with an increase in all-cause mortality among patients with < @ % and @ % -@ % predicted risk of death ( odds ratio -LSB- OR -RSB- @ , @ % CI @-@ @ , p < @ , and OR @ , @ % CI @-@ @ , p < @ , respectively ) , but with a decrease in all-cause mortality in patients with > @ % predicted risk of death ( OR @ , @ % CI @-@ @ , p < @ ) .


Transfusion was associated with an increase in fatal and non-fatal vascular events ( OR @ , @ % CI @-@ @ , p < @ ) .


The risk associated with RBC transfusion was significantly increased for all the predicted risk of death categories , but the relative increase was higher for those with the lowest ( < @ % ) predicted risk of death ( p-value for interaction < @ ) .


As this was an observational study , the results could have been affected by different types of confounding .


In addition , we could not consider haemoglobin in our analysis .


In sensitivity analyses , excluding patients who died early ; conducting propensity score analysis adjusting by use of platelets , fresh frozen plasma , and cryoprecipitate ; and adjusting for country produced results that were similar .


The association of transfusion with all-cause mortality appears to vary according to the predicted risk of death .


Transfusion may reduce mortality in patients at high risk of death but increase mortality in those at low risk .


The effect of transfusion in low-risk patients should be further tested in a randomised trial .


The objective of this trial was to determine how a mucoadhesive hydrogel ( MuGard ) , a marketed medical device , would fare when tested with the strictness of a conventional multi-institutional , double-blind , randomized , placebo-controlled study format .


A total of @ subjects planned to receive chemoradiation therapy ( CRT ) for treatment of head and neck cancers were randomized to receive either MuGard or sham control rinse ( SC ) during CRT .


Subjects completed the validated Oral Mucositis Daily Questionnaire .


Weight , opiate use , and World Health Organization ( WHO ) oral mucositis ( OM ) scores were recorded .


Subjects who dosed at least once daily during the first @ weeks of CRT were included in the efficacy analysis .


Of @ subjects enrolled , @ ( SC , N = @ ; MuGard , N = @ ) were eligible for efficacy analysis .


Both cohorts were similar in demographics , baseline characteristics , primary tumor type , and planned CRT regimen .


MuGard effectively mitigated OM symptoms as reflected by area under the curve of daily patient-reported oral soreness ( P = @ ) and WHO scores on the last day of radiation therapy ( P = @ ) .


MuGard was also associated with nonsignificant trends related to therapeutic benefit including opioid use duration , and OM scores ( WHO criteria ) at CRT week @ .


Rinse compliance was identical between cohorts .


No significant adverse events were reported , and the adverse event incidence was similar between cohorts .


Testing MuGard , a rinse marketed as a device , in a standard clinical trial format demonstrated its superiority to SC in mitigating OM symptoms , delaying OM progression , and its safety and tolerability .


The European Organization for Research and Treatment of Cancer ( EORTC ) @ phase @ randomized clinical trial compared @ schemes of combined chemotherapy for patients with resectable cancers of the hypopharynx and larynx : sequential induction chemotherapy and radiotherapy versus alternating chemoradiotherapy .


The current study reports detailed effects of both treatment arms on health-related quality of life ( HRQOL ) and symptoms .


A total of @ patients aged @ years to @ years ( World Health Organization performance status ( WHO PS ) @ ) with untreated , resectable advanced squamous cell carcinoma of the larynx ( tumor classification of T@-T@ ) or hypopharynx ( tumor classification of T@-T@-T@ ) with regional lymph nodes in the neck classified as N@ to N@ with no metastases were randomized in this prospective phase @ trial into either the sequential arm ( control ) or the alternating arm ( experimental ) .


QOL assessment was performed at randomization ; at baseline ; at @ days ; and at @ , @ , @ , @ , and @ months .


There were no observed differences with regard to the primary endpoint of Fatigue and secondary endpoint of Dyspnea .


Significant differences were found in the secondary endpoints of Swallowing and Speech problems at @ days after randomization in favor of patients in the sequential arm .


Explanatory and sensitivity analysis revealed that the primary analysis favored the sequential arm , but the majority of differences in HRQOL did not exist at the end of treatment , and returned to baseline levels .


In the current study , a trend toward worse scores was noted in the patients treated on the alternating chemoradiotherapy arm but very few differences reached the level of statistical significance .


The HRQOL scores of the majority of patients returned to baseline after therapy .


This study sought to establish the efficacy of single-lead , @-wk peripheral nerve stimulation ( PNS ) therapy for pain reduction in stroke survivors with chronic hemiplegic shoulder pain .


This study is a single-site , pilot , randomized controlled trial of adults with chronic shoulder pain after stroke .


Participants were randomized to receive a @-wk treatment of single-lead PNS or usual care .


The primary outcome was the worst pain in the last week ( Brief Pain Inventory , Short Form , question @ ) measured at baseline and weeks @ , @ , @ , and @ .


The secondary outcomes included pain interference ( Brief Pain Inventory , Short Form , question @ ) , pain measured by the ShoulderQ Visual Graphic Rating Scales , and health-related quality-of-life ( Short-Form @ version @ ) .


Twenty-five participants were recruited , @ to PNS and @ to usual care .


There was a significantly greater reduction in pain for the PNS group compared with the controls , with significant differences at @ and @ wks after treatment .


Both PNS and usual care were associated with significant improvements in pain interference and physical health-related quality-of-life .


Short-term PNS is a safe and efficacious treatment of shoulder pain .


Pain reduction is greater compared with usual care and is maintained for at least @ wks after treatment .


When a surgeon uses a percutaneous volar approach to treat scaphoid waist fractures , central screw placement is complicated by the shape of the scaphoid and by obstruction by the trapezium .


In this study , we used radiographs and biomechanical tests to compare the standard volar percutaneous approach with the transtrapezial approach , with regard to central screw placement at the distal pole of the scaphoid .


Fourteen matched pairs of cadaveric wrists were randomly assigned to two treatment groups .


Under fluoroscopic control , a guidewire was drilled into the scaphoid , either through a transtrapezial approach or through a standard volar approach that avoided the trapezium .


Guidewire position was measured in the coronal and sagittal planes .


A transverse osteotomy was performed along the scaphoid waist , and this was followed by the insertion of the longest possible cannulated headless bone screw .


Each specimen was placed into a fixture with a pneumatically driven plunger resting on the surface of the distal pole .


Load was applied by using a load-controlled test protocol in a hydraulic testing machine .


All guidewires were inside the central one-third of the proximal pole .


The guidewire positions at the distal pole differed significantly between the transtrapezial and standard volar approach groups ( p < @ ) .


The load to @ mm of displacement and the load to failure averaged , respectively , @ N ( standard error of the mean -LSB- SEM -RSB- = @ N ) and @ N ( SEM = @ N ) for the transtrapezial approach group compared with @ N ( SEM = @ N ) ( p = @ ) and @ N ( SEM = @ N ) ( p = @ ) for the standard volar approach group .


The data suggest that , in a cadaveric osteotomy-simulated scaphoid waist fracture model , the transtrapezial approach reliably achieves central positioning of a screw in the proximal and distal poles .


This position offers a biomechanical advantage compared with central placement in only the proximal pole .


The characteristics of each inhalation maneuver when patients use dry powder inhalers ( DPIs ) are important , because they control the quality of the emitted dose .


We have measured the inhalation profiles of asthmatic children -LSB- CHILD ; n = @ , mean forced expiratory volume in @sec ( FEV@ ) @ % predicted -RSB- , asthmatic adults ( ADULT ; n = @ , mean predicted FEV@ @ % ) , and chronic obstructive pulmonary disease ( COPD ; n = @ , mean predicted FEV@ @ % ) patients when they inhaled through an Aerolizer , Diskus , Turbuhaler , and Easyhaler using their `` real-life '' DPI inhalation technique .


These are low - , medium - , medium/high - , and high-resistance DPIs , respectively .


The inhalation flow against time was recorded to provide the peak inhalation flow ( PIF ; in L/min ) , the maximum pressure change ( P ; in kPa ) , acceleration rates ( ACCEL ; in kPa/sec ) , time to maximum inhalation , the length of each inhalation ( in sec ) , and the inhalation volume ( IV ; in liters ) of each inhalation maneuver .


PIF , P , and ACCEL values were consistent with the order of the inhaler 's resistance .


For each device , the inhalation characteristics were in the order ADULT > COPD > CHILD for PIF , P , and ACCEL ( p < @ ) .


The results showed a large variability in inhalation characteristics and demonstrate the advantages of P and ACCEL rather than PIFs .


Overall inhaled volumes were low , and only one patient achieved an IV > @L and P > @kPa .


The large variability of these inhalation characteristics and their range highlights that if inhalation profiles were used with compendial in vitro dose emission measurements , then the results would provide useful information about the dose patients inhale during routine use .


The inhalation characteristics highlight that adults with asthma have greater inspiratory capacity than patients with COPD , whereas children with asthma have the lowest .


The significance of the inhaled volume to empty doses from each device requires investigation .


Median survival of non-small cell lung cancer ( NSCLC ) patients with brain metastases is poor .


We examined concurrent erlotinib and whole brain radiotherapy ( WBRT ) followed by maintenance erlotinib in patients with untreated brain metastases , given the potential radiosensitizing properties of erlotinib and its direct effect on brain metastases and systemic activity .


Eighty NSCLC patients with KPS of @ and greater and multiple brain metastases were randomly assigned to placebo ( n = @ ) or erlotinib ( @mg , n = @ ) given concurrently with WBRT ( @ Gy in @ fractions ) .


Following WBRT , patients continued with placebo or erlotinib ( @ mg ) until disease progression .


The primary end point was neurological progression-free survival ( nPFS ) ; hazard ratios ( HRs ) were calculated using Cox regression .


All P values were two-sided .


Fifteen patients ( @ % ) from each arm were alive and without neurological progression @ months after WBRT .


Median nPFS was @ months in both arms ; nPFS HR @ ( @ % CI = @ to @ ; P = @ ) .


Median overall survival ( OS ) was @ and @ months in the placebo and erlotinib arms ; HR @ ( @ % CI = @ to @ ; P = @ ) .


The frequency of epidermal growth factor receptor ( EGFR ) mutations was low with only @ of @ ( @ % ) patients with available samples had activating EGFR-mutations .


Grade @/@ adverse event rates were similar between the two groups ( @ % in each arm ) , except for rash @ % ( erlotinib ) vs @ % ( placebo ) , and fatigue @ % vs @ % .


No statistically significant quality of life differences were found .


Our study showed no advantage in nPFS or OS for concurrent erlotinib and WBRT followed by maintenance erlotinib in patients with predominantly EGFR wild-type NSCLC and multiple brain metastases compared to placebo .


Future studies should focus on the role of erlotinib with or without WBRT in patients with EGFR mutations .


Osmotic-controlled release oral delivery system ( OROS ) hydromorphone - an extended-release preparation - is recommended long-term therapy for chronic pain patients .


Dose proportionality of OROS hydromorphone has been shown in healthy Caucasian volunteers ; however , no studies have been conducted in Asian populations .


To determine whether ethnic differences affect the drug 's pharmacokinetic ( PK ) profile , we evaluated the dose proportionality of OROS hydromorphone in healthy Taiwanese adults .


This @-week , open-label , @-way crossover , phase @ study randomly assigned subjects to @ of @ treatment sequences - single oral dose OROS hydromorphone : @ mg , @ mg , @ mg , or @ mg - along with @ mg naltrexone .


Dose proportionality was assessed using a linear mixed-effects model to estimate the slope of the regression line and its @ % CI for Cmax , AUC@-@h , and AUClast .


Descriptive statistics measured plasma hydromorphone concentrations , PK parameters , laboratory analytes , and vital signs .


@ subjects completed the study ; a single-dose of OROS hydromorphone increased plasma concentration steadily for @ hours and sustained it at or near maximum levels for ~ @ hours .


After dose normalization to a @ mg dose , all studied doses demonstrated dose proportionality for Cmax , AUClast , and AUC@-@h , as the slopes of the regression lines for Cmax , AUClast , and AUC@-@h were close to zero , and the @ % CIs within pre-specified limits .


Adverse events were as expected for hydromorphone administered with concomitant naltrexone .


Single doses of @ mg , @ mg , @ mg , and @ mg of OROS hydromorphone were found to be dose proportional for Cmax , AUClast , and AUC@-@h and were generally safe and well-tolerated in healthy Taiwanese adults .


Treatment with inhaled glucocorticoids in combination with long-acting bronchodilators is recommended in patients with frequent exacerbations of severe chronic obstructive pulmonary disease ( COPD ) .


However , the benefit of inhaled glucocorticoids in addition to two long-acting bronchodilators has not been fully explored .


In this @-month , double-blind , parallel-group study , @ patients with a history of exacerbation of COPD received triple therapy consisting of tiotropium ( at a dose of @ g once daily ) , salmeterol ( @ g twice daily ) , and the inhaled glucocorticoid fluticasone propionate ( @ g twice daily ) during a @-week run-in period .


Patients were then randomly assigned to continued triple therapy or withdrawal of fluticasone in three steps over a @-week period .


The primary end point was the time to the first moderate or severe COPD exacerbation .


Spirometric findings , health status , and dyspnea were also monitored .


As compared with continued glucocorticoid use , glucocorticoid withdrawal met the prespecified noninferiority criterion of @ for the upper limit of the @ % confidence interval ( CI ) with respect to the first moderate or severe COPD exacerbation ( hazard ratio , @ ; @ % CI , @ to @ ) .


At week @ , when glucocorticoid withdrawal was complete , the adjusted mean reduction from baseline in the trough forced expiratory volume in @ second was @ ml greater in the glucocorticoid-withdrawal group than in the glucocorticoid-continuation group ( P < @ ) ; a similar between-group difference ( @ ml ) was seen at week @ ( P = @ ) .


No change in dyspnea and minor changes in health status occurred in the glucocorticoid-withdrawal group .


In patients with severe COPD receiving tiotropium plus salmeterol , the risk of moderate or severe exacerbations was similar among those who discontinued inhaled glucocorticoids and those who continued glucocorticoid therapy .


However , there was a greater decrease in lung function during the final step of glucocorticoid withdrawal .


( Funded by Boehringer Ingelheim Pharma ; WISDOM ClinicalTrials.gov number , NCT@ . )


To evaluate the anti-gingivitis benefits of a @ % highly bioavailable stannous fluoride dentifrice ( SnF@ ) relative to a @ % triclosan/copolymer dentifrice ( triclosan/copolymer ) among triclosan/copolymer dentifrice users with residual gingivitis .


This was a randomized , controlled , double-blind , parallel group , @-month clinical study .


Self-reported triclosan/copolymer dentifrice users were recruited and provided with triclosan/copolymer dentifrice to use for @ month .


After this @-month acclimation period , subjects who had residual gingivitis at the baseline visit were randomized to either the SnF@ dentifrice or the triclosan/copolymer dentifrice ( positive control ) .


Subjects performed their treatment unsupervised using their assigned dentifrice following manufacturers ' usage instructions for @ months .


The Gingival Bleeding Index ( GBI ) and Modified Gingival Index ( MGI ) were used to measure gingivitis benefits at baseline and Month @ .


An analysis of covariance was performed to compare treatment groups for the post-baseline scores as well as change from baseline , with the baseline score as a covariate .


All comparisons were two-sided at the @ level of significance .


A total of @ subjects were randomized to treatment .


Both treatment groups experienced significant reductions in number of bleeding sites , gingival bleeding index ( GBI ) , and gingival inflammation ( MGI ) relative to baseline ( P < @ ) .


At Month @ , the SnF@ dentifrice group demonstrated significantly lower adjusted mean scores versus the triclosan/copolymer group for number of bleeding sites , GBI , and MGI ( P < @ ) .


Between-treatment group comparisons for change from baseline values showed that the improvement in number of bleeding sites from baseline for the SnF@ group was @ % greater versus that of the triclosan/copolymer group ( P < @ ) , and the GBI and MGI improvements from baseline for the SnF@ group were @ % and @ % , greater , respectively , relative to the triclosan/copolymer group ( P < @ ) .


To compare two different vitrification methods to slow freezing method for cryopreservation of human cleavage stage embryos .


Prospective randomised trial .


University assisted reproduction centre .


@ patients ( mean age @ @ ) from April @ to April @ .


@ supernumerary good-quality cleavage stage embryos in @ IVF cycles intended to be cryopreserved were randomly allocated to three groups : slow freezing , vitrification with the Irvine method , vitrification with the Vitrolife method .


Embryo survival and cleavage rates , implantation rate .


A total of @ embryos were warmed , @ ( @ % ) survived and @ were finally transferred ( @ % ) .


Post-warming embryos survival rate was significantly higher after vitrification ( Irvine : @ % ; Vitrolife : @ % ) than after slow freezing ( @ % ) ( p < @ ) .


No differences in survival rates were observed between the two vitrification methods , but a significant higher cleavage rate was observed using Irvine compared to Vitrolife method ( p < @ ) .


Implantation rate ( IR ) per embryo replaced and per embryo warmed were respectively @ % ( @/@ ) and @ % ( @/@ ) for Irvine , @ % ( @/@ ) and @ % ( @/@ ) for Vitrolife , @ % ( @/@ ) and @ % ( @/@ ) for slow-freezing ( NS ) .


Both vitrification methods ( Irvine and Vitrolife ) are more efficient than slow freezing for cryopreservation of human cleavage stage embryos in terms of post-warming survival rate .


No significant difference in the implantation rate was observed between the three cryopreservation methods .


To evaluate rectal dose and post-treatment patient-reported bowel quality of life ( QOL ) following radiation therapy for prostate cancer .


Patient-reported QOL was measured at baseline and @-years via the expanded prostate cancer index composite ( EPIC ) for @ patients .


Linear regression modeling was performed using the baseline score for the QUANTEC normal tissue complication probability model and dose volume histogram ( DVH ) parameters for the whole and segmented rectum ( superior , middle , and inferior ) .


At @-years the mean summary score declined from a baseline of @-@ @ .


The median volume of rectum treated to @ Gy ( V@ ) was @ % for the whole rectum and @ % , @ % , and @ % for the inferior , middle , and superior rectum , respectively .


Mean dose to the whole and inferior rectum correlated with declines in bowel QOL while dose to the mid and superior rectum did not .


Low ( V@-V@ ) , intermediate ( V@-V@ ) and high ( V@-V@ ) doses to the inferior rectum influenced bleeding , incontinence , urgency , and overall bowel problems .


Only the highest dose ( V@ ) to the mid-rectum correlated with rectal bleeding and overall bowel problems .


Segmental DVH analysis of the rectum reveals associations between bowel QOL and inferior rectal dose that could significantly influence radiation planning and prognostic models .


To evaluate the effect of intravitreal aflibercept injection on visual function in wet age-related macular degeneration ( AMD ) .


Prospective , multicenter , double-masked , active-controlled , parallel-group , randomized phase @ clinical studies ( VEGF Trap-Eye : Investigation of Efficacy and Safety in Wet AMD -LSB- VIEW -RSB- @ and @ -LSB- clinicaltrials.gov identifiers , NCT@ and NCT@ , respectively -RSB- ) .


Patients ( n = @ ) with active , treatment-nave , exudative AMD .


This analysis included patients who received intravitreal aflibercept @ mg every @ weeks ( @q@ ; n = @ ) or ranibizumab @ mg every @ weeks ( @ q@ ; n = @ ) .


Patients were randomized @:@:@:@ to receive intravitreal aflibercept @q@ ( after @ initial monthly doses ) , intravitreal aflibercept @q@ , intravitreal aflibercept @ q@ , or ranibizumab @ q@ in the study eye .


Patients in the intravitreal aflibercept @q@ group received a sham injection alternating with active treatment .


The @-item National Eye Institute Visual Function Questionnaire ( NEI VFQ-@ ) was administered at baseline and at weeks @ , @ , @ , and @ .


The NEI VFQ-@ subscale scores were compared between intravitreal aflibercept @q@ and ranibizumab @ q@ treatment arms , the approved dosing for each agent worldwide .


Change in composite NEI VFQ-@ score was evaluated based on categorical change in visual acuity ( worsened , unchanged , improved ) .


Baseline NEI VFQ-@ scores were similar for both treatments in both studies .


Mean change from baseline to @ weeks was similar for ranibizumab @ q@ and intravitreal aflibercept @q@ across all @ subscales , with the greatest improvements noted for mental health and general vision ( @-@ @ points , both treatments , both studies ) .


Improvement of @ points or more ( both treatments , both studies ) also was observed for subscales near vision , distance vision , role difficulties , and dependency .


Mean change from baseline to @ weeks in NEI VFQ-@ composite score ( pooled data ) stratified by clinical response showed meaningful improvement only in patients who gained @ Early Treatment Diabetic Retinopathy letters or more ( @ and @ points for intravitreal aflibercept @q@ and ranibizumab @ q@ , respectively ) .


Visual function outcomes were similar across all NEI VFQ-@ subscales over @ weeks for intravitreal aflibercept @q@ and ranibizumab @ q@ , with clinically meaningful improvement recorded in @ of @ subscales .


To evaluate the effect of length of tibial stump on proprioceptive recovery after anterior cruciate ligament ( ACL ) reconstruction .


From March @ to December @,@ patients with ACL tear were performed with reconstruction .


The patients were divided randomly into three groups : group A , the patients with remained length of tibial stump ranging from @ to @ mm , including @ males and @ females , with an average age of ( @ @ ) years old ; group B , the patients with remained length of tibial stump ranging from @ to @ mm , including @ males and @ females , with an average age of ( @ @ ) years old ; group C , the patients with remained length of tibial stump less than @ mm , including @ males and @ females , with an average age of ( @ @ ) years , old .


The stability of knee were assessed by Lanchman test and anterior drawer test .


The function of knee was assessed by Lysholm score and Tegner activity rating .


The proprioceptive recovery was evaluated by assessing the passive reproduction of the angles with limb movement into flexion and extension in no weight bearing position .


Lanchman test and anterior drawer test of all patients were negative at @ months postoperatively. , and there was one case of positive outcome in each group at @ month and @ month postoperatively .


Lysholm score and Tegner activity score of all patients at @ month postoperatively were significantly better than that preoperatively , and there were no significant difference among three groups at @ month postoperatively .


There were no significant difference in the production of the angles at flexion to @ and extention to @ and @ among these groups before and after operation .


The reproduction of the angles of group A and B at flexion to @ and extention to @ at @ month postoperatively were significantly better than that of group A and B preoperatively and that of group C at @ month postoperatively , and there were no significant difference among three groups at @ month postoperatively .


The reproduction of the angles of group A and B at flexion to @ at @ month postoperatively were significantly better than that of group A and B preoperatively and that of group C at @ month postoperatively , and there were no significant difference among three groups at @ month postoperatively .


Preservation of tibial stump in ACL reconstruction has benefit in proprioceptive recovery at early stage postoperatively and the length of tibial stump should be reserved with a range from @ to @ mm .


To determine whether a single treatment of botulinum toxin A in the forehead ( glabellar ) region can improve symptoms of depression in patients with major depressive disorder ( MDD ) , as defined by DSM-IV criteria .


Thirty participants were randomly assigned to receive either placebo or botulinum toxin A ( BTA ; onabotulinumtoxinA ) injections in the forehead .


Female participants received @ units ; male participants received @ units .


At week @ , the groups were crossed over .


Participants were evaluated at weeks @ , @ , @ , @ , @ , @ , and @ for improvement in MDD symptoms using the Patient Health Care Questionnaire-@ , Beck Depression Inventory ( BDI ) , and @-Item Hamilton Depression Rating Scale ( HDRS-@ ) objective measurement scales .


The primary outcome was the rate of HDRS-@ response , defined as @ % score reduction from baseline .


The study occurred from July @ to November @ .


Patients who received BTA at week @ ( BTA-first group ) and at week @ ( BTA-second group ) had a statistically significant reduction in MDD symptoms as compared to placebo .


Improvement in MDD continued over @ weeks in the group that received BTA first even though the cosmetic effects of BTA wore off at @ to @ weeks .


HDRS-@ response rates were @ % ( @/@ ) in the BTA-first group , @ % ( @/@ ) in the BTA-second group , and @ % ( @/@ ) in the placebo group ( P < @ ) .


HDRS-@ remission rates ( score @ ) were @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) , respectively ( P = @ ) .


HDRS-@ scores dropped -@ % and -@ % in the BTA-first and - second groups versus -@ % in the placebo group ( P < @ ) .


The BDI response rate ( @ % reduction from baseline ) was @ % ( @/@ ) in the BTA-first group , @ % ( @/@ ) in the BTA-second group , and @ % ( @/@ ) in the placebo group ( P = @ ) .


BDI remission rates ( score @ ) were @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) , respectively ( P = @ ) .


BDI scores dropped -@ % and -@ % in the BTA-first and - second groups versus -@ % in the placebo group ( P < @ ) .


Botulinum toxin A injection in the glabellar region was associated with significant improvement in depressive symptoms and may be a safe and sustainable intervention in the treatment of MDD .


To compare @ omega-@ ( n-@ ) preparations enriched with eicosapentaenoic acid ( EPA ) versus docosahexaenoic acid ( DHA ) as monotherapy for major depressive disorder ( MDD ) in a @-site , placebo-controlled , randomized , double-blind clinical trial .


@ adults ( @ % female ; mean -LSB- SD -RSB- age = @ -LSB- @ -RSB- years ) with DSM-IV MDD and a baseline @-item Hamilton Depression Rating Scale ( HDRS-@ ) score @ were randomized equally from May @ , @ , to June @ , @ , to @ weeks of double-blind treatment with oral EPA-enriched n-@ @ mg/d , DHA-enriched n-@ @,@ mg/d , or placebo .


@ subjects completed the study .


Modified intent-to-treat ( mITT ) analysis ( n = @ subjects with @ postbaseline visit ; @ % female , mean -LSB- SD -RSB- age @ -LSB- @ -RSB- years ) employed mixed-model repeated measures ( MMRM ) .


All @ groups demonstrated statistically significant improvement in the HDRS-@ ( primary outcome measure ) , @-item Quick Inventory of Depressive Symptomatology-Self Report ( QIDS-SR-@ ) , and Clinical Global Improvement-Severity Scale ( CGI-S ) ( P < @ ) , but neither n-@ preparation separated from placebo ( P > @ ) .


Response and remission rates were in the range of @ % -@ % and @ % , respectively , for all treatments , with no significant differences between groups .


One subject receiving EPA-enriched n-@ discontinued due to worsening depression , and @ subject receiving placebo discontinued due to an unspecified `` negative reaction '' to pills .


Neither EPA-enriched nor DHA-enriched n-@ was superior to placebo for the treatment of MDD .


To compare the @-year stability , survival , and tolerability of @ osseointegrated implants for bone conduction hearing : a wide @-mm-diameter moderately roughened implant with a rounded @-mm abutment ( test ) and a @-mm diameter as-machined implant with a conically shaped @-mm abutment ( control ) .


In this randomized , prospective , controlled , multicenter clinical study , @ adult patients were included .


Test and control implants were randomly assigned in proportions of @:@ .


The implants were loaded with the sound processor from @ weeks postimplantation .


Follow-up after surgery was conducted at @ days ; at @ , @ , @ , and @ weeks ; and at @ , @ , @ , and @ months after surgery .


At every visit , implant stability quotient ( ISQ ) values were recorded by means of resonance frequency analysis ( RFA ) , and skin reactions were evaluated according to Holgers ' classification .


Statistically significantly higher mean ISQ values were recorded for the test implant compared with the control implant at each evaluation time point .


Between @ and @ years after surgery , ISQ values decreased but remained above baseline values .


Implant survival was high for both implants : @ % of the test implants and @ % of the control implants survived these @ years .


Statistically significantly improved soft tissue outcomes were observed in the test implant group .


This extensive long-term clinical investigation demonstrated that the test implant is more stable in terms of ISQ-values and provides high tolerability for the soft tissue .


The results show that implant loading at @ weeks is safe .


To evaluate the short-term effects of three different resistance training programs , conducted at low intensity , on physical performance , muscle cross-sectional area ( CSA ) and the capacity to perform daily tasks in older adults living in a geriatric nursing home .


Randomized controlled trial , with a @-month intervention period .


A geriatric nursing home in Valencia , Spain .


Eighty-nine adults aged @ to @ who were independent in their daily activities .


After a baseline assessment , the participants were randomly assigned to the control group or one of the three intervention groups : volitional contraction ( VC ; n = @ ) , neuromuscular electrical stimulation ( NMES ; n = @ ) , or neuromuscular electrical stimulation superimposed onto voluntary contractions ( NMES + ; n = @ ) .


The intervention focused on knee extension exercises and its intensity was set at @ % of one-repetition maximum ( @RM ) .


The primary outcome measure was mobility .


Secondary outcomes were rectus femoris CSA , balance , aerobic endurance , upper-body strength and the capacity to perform daily tasks .


All data were collected at baseline and after the @-month intervention period .


The two-way ANOVA analysis showed a significant grouptime interaction effect for the mobility ( P = @ ) , rectus femoris CSA ( P = @ ) , and the capacity to perform daily tasks ( P = @ ) .


The within-group analysis found a more prominent effect in the NMES + group .


Significant improvements were seen in rectus femoris CSA and the capacity to perform daily tasks in all intervention groups .


Mobility only improved in the NMES + group ( P = @ ) .


From a short-term perspective , NMES + exercise training , performed at low intensity , can improve physical performance , muscle CSA , and the capacity to perform daily activities , and to partially mitigate age-related consequences in older adults .


Treatment motivation is a key component in the early rehabilitative stages for people with substance use disorders .


To date , no music therapy researcher has studied how lyric analysis interventions might affect motivation in a randomized controlled design .


The primary purpose of this study was to determine the effect of lyric analysis interventions on treatment motivation in patients on a detoxification unit using a single-session wait-list control design .


A secondary purpose was to determine if there were between-group differences concerning two contrasting songs used for the lyric analyses .


Participants ( N = @ ) were cluster randomized to a group lyric analysis condition or a wait-list control condition .


Participants received either a `` Hurt '' or a `` How to Save a Life '' lyric analysis treatment .


The Texas Christian University Treatment Motivation Scale-Client Evaluation of Self at Intake ( CESI ) ( Simpson , @ -LSB- @ -RSB- ) was used to measure aspects of treatment motivation : problem recognition , desire for help , treatment readiness , pressures for treatment , and total motivation .


Results indicated significant between-group differences in measures of problem recognition , desire for help , treatment readiness , and total motivation , with experimental participants having higher treatment motivation means than control participants .


There was no difference between the two lyric analysis interventions .


Although the song used for lyric analysis interventions did not affect outcome , a single group-based music therapy lyric analysis session can be an effective psychosocial treatment intervention to enhance treatment motivation in patients on a detoxification unit .


Limitations , implications for clinical practice , and suggestions for future research are provided .


The effects of two interventions , Integrated Management of Infectious Disease ( IMID ) training program and On-Site Support ( OSS ) , were tested on @ facility performance indicators for emergency triage assessment and treatment ( ETAT ) , malaria , pneumonia , tuberculosis , and HIV .


The trial was implemented in @ primary care facilities in Uganda .


From April @ , two mid-level practitioners per facility participated in IMID training .


Eighteen of @ facilities were randomly assigned to Arm A , and received OSS in @ ( nine monthly two-day sessions ) ; @ facilities assigned to Arm B did not receive OSS in @ .


Data were collected from Nov @ to Dec @ using a revised Ministry of Health outpatient medical form and nine registers .


We analyzed the effect of IMID training alone by measuring changes before and during IMID training in Arm B , the combined effect of IMID training and OSS by measuring changes in Arm A , and the incremental effect of OSS by comparing changes across Arms A and B.


IMID training was associated with statistically significant improvement in three indicators : outpatients triaged ( adjusted relative risks ( aRR ) = @ , @ % CI = @,@ ) , emergency and priority patients admitted , detained , or referred ( aRR = @ , @ % CI = @,@ ) , and pneumonia suspects assessed ( aRR = @ , @ % CI = @,@ ) .


IMID training and OSS combined was associated with improvements in six indicators : three ETAT indicators ( outpatients triaged ( aRR = @ , @ % CI = @,@ ) , emergency and priority patients admitted , detained or referred ( aRR = @ , @ % CI = @,@ ) , and emergency patients receiving at least one appropriate treatment ( aRR = @ , @ % CI = @,@ ) ) ; two malaria indicators ( malaria cases receiving appropriate antimalarial ( aRR = @ , @ % CI = @,@ ) , and patients with negative malaria test results prescribed antimalarial ( aRR = @ , @ % CI = @,@ ) ) ; and enrollment in HIV care ( aRR = @ , @ % CI = @,@ ) .


OSS was associated with incremental improvement in emergency patients receiving at least one appropriate treatment ( adjusted ratio of RR = @,@ % CI = @,@ ) .


The trial showed that the OSS intervention significantly improved performance in one of @ facility indicators .


Glaucoma is one of the leading causes of blindness .


Reduction of intraocular pressure is the only proven way to prevent progression of glaucomatous optic neuropathy .


The majority of glaucoma patients need to use antiglaucoma ophthalmic solutions over the course of their life .


Thus , good adherence and persistency of glaucoma treatment are important factors for better glaucoma care .


The purpose of this study was to investigate the impact of an Internet-based glaucoma care support system on glaucoma medication use .


Patients were randomly divided into two groups .


The non-Internet access ( NIA ) group consisted of patients who had access to the Internet-based glaucoma care support system during the @-year period only when they were examined by ophthalmologists .


The Internet access ( IA ) group consisted of patients who had the same Internet-based glaucoma care support system access as the NIA group for the first @ years following enrollment but who were also given free access to the glaucoma care support system for the remaining @ years .


Changes in glaucoma medication use were investigated .


In total , @ patients in the IA group and @ patients in the NIA group satisfied the study protocol .


The number of antiglaucoma ophthalmic solutions used during the study period significantly increased in the NIA group ( P < @ ) but not in the IA group .


The percentages of patients with unchanged , increased , and decreased antiglaucoma ophthalmic solution use during the study period were @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) , respectively , in the NIA group , and @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) , respectively , in the IA group ( P < @ ) .


Internet access significantly shifted from an increasing intraocular pressure trend to a decreasing trend in the IA group ( P = @ ) among the patients who did not have any medication changes .


Allowing patients to browse their medical data may reduce the use and improve the effectiveness of glaucoma medication .


To confirm the superiority of transdermal rotigotine up to @mg/@h over placebo , and non-inferiority to ropinirole , in Japanese Parkinson 's disease ( PD ) patients on concomitant levodopa therapy .


This trial was a randomized , double-blind , double-dummy , three-arm parallel group placebo - and ropinirole-controlled trial .


Four-hundred and twenty PD patients whose motor symptoms were not well controlled by levodopa treatment were randomized @:@:@ to receive rotigotine , ropinirole ( up to @mg/day ) or placebo during a @-week treatment period followed by a @-week taper period .


The primary variable was change in the Unified Parkinson 's Disease Rating Scale ( UPDRS ) Part III ( ON state ) sum score from baseline to the end of the treatment period .


The difference in the change in the UPDRS Part III ( ON state ) sum score from baseline to the end of treatment between rotigotine and placebo groups was-@ @ ( @ % CI : -@ to-@ @ ; p < @ ) , indicating superiority of rotigotine over placebo .


The difference between rotigotine and ropinirole groups was-@ @ ( @ % CI : -@ to @ ) , below the non-inferiority margin , indicating the non-inferiority of rotigotine to ropinirole .


Application site reaction was seen in @ % of the patients in the rotigotine group and in @ % in the ropinirole group ( P < @ ) .


No other safety issue was noted .


Rotigotine was well tolerated at doses up to @mg/@h and showed similar efficacy to ropinirole except that the application site reaction was much higher in the rotigotine group .


Ultrasound-guided foam sclerotherapy and endovenous laser ablation are widely used alternatives to surgery for the treatment of varicose veins , but their comparative effectiveness and safety remain uncertain .


In a randomized trial involving @ participants with primary varicose veins at @ centers in the United Kingdom , we compared the outcomes of foam , laser , and surgical treatments .


Primary outcomes at @ months were disease-specific quality of life and generic quality of life , as measured on several scales .


Secondary outcomes included complications and measures of clinical success .


After adjustment for baseline scores and other covariates , the mean disease-specific quality of life was slightly worse after treatment with foam than after surgery ( P = @ ) but was similar in the laser and surgery groups .


There were no significant differences between the surgery group and the foam or the laser group in measures of generic quality of life .


The frequency of procedural complications was similar in the foam group ( @ % ) and the surgery group ( @ % ) but was lower in the laser group ( @ % ) than in the surgery group ( P < @ ) ; the frequency of serious adverse events ( approximately @ % ) was similar among the groups .


Measures of clinical success were similar among the groups , but successful ablation of the main trunks of the saphenous vein was less common in the foam group than in the surgery group ( P < @ ) .


Quality-of-life measures were generally similar among the study groups , with the exception of a slightly worse disease-specific quality of life in the foam group than in the surgery group .


All treatments had similar clinical efficacy , but complications were less frequent after laser treatment and ablation rates were lower after foam treatment .


( Funded by the Health Technology Assessment Programme of the National Institute for Health Research ; Current Controlled Trials number , ISRCTN@ . )


The purpose of the present study was to determine whether lamivudine in combination with transarterial chemoembolization ( TACE ) could reduce hepatitis B virus ( HBV ) activation and improve the survival of patients with hepatocellular carcinoma ( HCC ) .


From July @ to October @ , a total of @ consecutive HBV-related HCC patients undergoing TACE were randomized to two groups ( @ : lamivudine , @ : control ) .


Follow up was every @ months .


Primary and secondary end-points were time to progression ( TTP ) and overall survival ( OS ) , respectively , both of which were evaluated by the Kaplan Meier technique and summarized by the hazard ratio .


The level of HBV-DNA became undetectable in @ ( @ % ) patients in the lamivudine group , compared with @ ( @ % ) in the control group ( P < @ ) .


The median TTP was @ months in lamivudine group and @ months in control group ( P = @ ) , and lamivudine therapy was an independent protective factor related to TTP ( P = @ ) .


Moreover , @ - , @ - , and @-year survival rates were @ % , @ % , and @ % in lamivudine group and @ % , @ % , and @ % in control group , respectively ( P = @ ) .


With multivariate Cox regression model , lamivudine therapy ( P = @ ) and - fetoprotein ( AFP ) level ( P = @ ) were two independent predictors for OS .


Lamivudine therapy could reduce HBV activation and improve survival of HCC patients treated with TACE .


Lamivudine therapy and AFP level are two independent factors affecting OS .


Pharyngocutaneous fistula is a common complication of total laryngectomy .


We hypothesized that perioperative proton pump inhibitor ( PPI ) treatment could reduce the incidence of pharyngocutaneous fistulae .


This prospective placebo-controlled double-blind randomized controlled trial compared PPI treatment ( @ days enteral omeprazole ) with a placebo in patients undergoing primary total laryngectomy .


Forty patients were randomized into PPI ( n = @ ) and placebo arms ( n = @ ) .


One of @ patients receiving omeprazole developed a fistula in comparison to @ of @ patients in the placebo group ( p = @ ) .


No other statistically significant risk factors for pharyngocutaneous fistula were identified .


The mean hospital stay of patients with and without a fistula was @ and @ days , respectively .


Pharyngocutaneous fistulae result in prolonged hospitalization and morbidity .


We observed a statistically significant reduction in fistulae with PPI prophylaxis .


Further research to better define the role of reflux and antacid management is suggested .


The aim of this study was to determine the possible existence of a correlation between the gastric transit time ( GTT ) measured by video capsule endoscopy ( VCE ) and the parameters of gastric emptying determined using @C breath test ( BreathID system ) .


Eight healthy male volunteers participated in this randomized , two-way crossover study .


The subjects were randomly assigned to undergo VCE using the PillCam SB capsule endoscopy system or the @C breath test for @ hours after a test meal ( @ kcal per @ mL ) containing @ mg of @C acetic acid administered after overnight fasting .


The VCE images were analyzed and the GTT was determined using the proprietary RAPID software .


The parameters , namely T lag , T @/@ and GEC were calculated using the Oridion Research Software ( version ) .


The GTT measured by VCE and the parameters of gastric emptying were compared statistically .


No significant correlation was observed between the GTT and T lag ( p = @ ) , T @/@ ( p = @ ) or GEC ( p = @ ) , as determined by calculation of the Spearmans rank correlation coefficient .


GTT measured by VCE can not serve as asubstitute for the gastric emptying time measured bythe @C breath test .


The efficacy of brace application for the treatment of osteoporotic compression fractures remains unclear .


The purpose of this study was to compare the treatment outcomes in patients with osteoporotic compression fractures with regard to whether the patients had no braces , rigid braces , or soft braces .


We randomly assigned sixty patients with acute one-level osteoporotic compression fractures within three days of injury to the no-brace , soft-brace , and rigid-brace groups through @:@:@ allocation .


The primary outcome was the baseline adjusted Oswestry Disability Index score at twelve weeks after compression fracture .


The non-inferior margin of the Oswestry Disability Index was set at an average of @ points .


The baseline adjusted Oswestry Disability Index score at twelve weeks after compression fracture in the no-brace group was not inferior to that in the soft-brace or rigid-brace groups .


The mean adjusted Oswestry Disability Index score was @ points ( @ % confidence interval , @ to @ points ) in the no-brace group and @ points ( @ % confidence interval , @ to @ points ) in the soft-brace group , with a difference of -@ points ( @ % confidence interval , -@ to @ points ) between the groups .


Similarly , the mean adjusted Oswestry Disability Index score was @ points ( @ % confidence interval , @ to @ points ) in the no-brace group and @ points ( @ % confidence interval , @ to @ points ) in the rigid-brace group , with a difference of @ points ( @ % confidence interval , -@ to @ points ) between the groups .


During the follow-up assessment period , there was no significant difference among the groups for the overall Oswestry Disability Index scores ( p = @ ) , visual analog scale for pain scores for back pain ( p = @ ) , and anterior body compression ratios ( p = @ ) .


However , the Oswestry Disability Index scores and the visual analog scale scores for back pain significantly improved with time after the fractures ( p < @ ) , and the body compression ratios significantly decreased with time in all three groups ( p < @ ) .


The Oswestry Disability Index scores for the treatment of compression fractures without a brace were not inferior to those with soft or rigid braces .


Moreover , the improvement in back pain and progression of anterior body compression were similar among the three groups .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


Present guidelines emphasise the importance of low concentrations of LDL cholesterol ( LDL-C ) in patients with familial hypercholesterolaemia .


In most patients with the disease , however , these concentrations are not achieved with present treatments , so additional treatment is therefore warranted .


Inhibition of cholesteryl ester transfer protein has been shown to reduce LDL-C concentrations in addition to regular statin treatment in patients with hypercholesterolaemia or at high risk of cardiovascular disease .


We aimed to investigate the safety and efficacy of anacetrapib , a cholesteryl ester transfer protein inhibitor , in patients with heterozygous familial hypercholesterolaemia .


In this multicentre , randomised , double-blind , placebo-controlled , phase @ study , patients aged @-@ years with a genotype-confirmed or clinical diagnosis of heterozygous familial hypercholesterolaemia , on optimum lipid-lowering treatment for at least @ weeks , and with an LDL-C concentration of @ mmol/L or higher without cardiovascular disease or @ mmol/L or higher with cardiovascular disease from @ lipid clinics across nine countries were eligible .


We randomly allocated participants with a computer-generated allocation schedule ( @:@ ; block size of six ; no stratification ) to oral anacetrapib @ mg or placebo for @ weeks , with a @ week post-treatment follow-up afterwards .


We masked patients , care providers , and those assessing outcomes to treatment groups throughout the study .


The primary outcome was percentage change from baseline in LDL-C concentration .


We did analysis using a constrained longitudinal repeated measures model .


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


Between Feb @ , @ , and Feb @ , @ , we randomly allocated @ patients to anacetrapib and @ to placebo .


One patient in the anacetrapib group did not receive the drug .


At week @ , anacetrapib reduced mean LDL-C concentration from @ mmol/L ( SD @ ) to @ mmol/L ( @ ; percentage change @ % -LSB- @ % CI -@ to -@ -RSB- compared with an increase with placebo from @ mmol/L ( @ ) to @ mmol/L ( @ ; percentage change @ % -LSB- -@ to @ -RSB- , with a difference in percentage change between anacetrapib and placebo of -@ % ( @ % CI -@ to -@ ; p < @ ) .


The number of cardiovascular events was increased in patients given anacetrapib compared with those given placebo ( @ -LSB- @ % -RSB- of @ vs none -LSB- @ % -RSB- of @ ; p = @ ) , but the proportion with adverse events leading to discontinuation was similar ( @ -LSB- @ % -RSB- of @ vs five -LSB- @ % -RSB- of @ ) .


In patients with heterozygous familial hypercholesterolaemia , treatment with anacetrapib for @ year was well tolerated and resulted in substantial reductions in LDL-C concentration .


Whether this change leads to a reduction of cardiovascular events will be answered in an outcome study .


To observe the clinical efficacy on pain in postmenopausal osteoporosis treated with the warm acupuncture therapy and discuss its effect mechanism .


Ninety cases of postmenopausal osteoporosis were randomized into a warm acupuncture group , an electroacupuncture group and a medication group , @ cases in each group .


In the warm acupuncture group and the electroacupuncture group , Dazhu ( BL @ ) , Shenshu ( BL @ ) and Xuanzhong ( GB @ ) were selected bilaterally and stimulated with the warm acupuncture and electroacupuncture therapies respectively , once a day for @ days totally .


In the medication group , caltrate-D tablets were prescribed , @ mg , once a day for @ days totally .


The changes in the bone density T value , visual analogue scale ( VAS ) score , serum insulin like growth factor @ ( IGF-@ ) , interleukin @ ( IL-@ ) and tumor necrosis factor ( TNF-alpha ) were observed before and after treatment in the three groups .


( @ ) The bone density T value in the patients of postmenopausal osteoporosis did not change obviously after @ days treatment with the three therapies ; ( @ ) VAS score was all reduced after treatment , in which , the result in the warm acupuncture group was the most obvious ( @ + / - @ before treatment vs @ + / - @ after treatment ) .


The value after treatment in the warm acupuncture group was different significantly as compared with the electroacupuncture group ( @ + / - @ ) and the medication group ( @ + / - @ , both P < @ ) .


( @ ) The level of serum IGF-@ was improved after treatment in the warm acupuncture therapy -LSB- ( @ + / - @ ) ng/mL before treatment vs ( @ + / - @ ) ng/mL after treatment -RSB- , which was more apparent as compared with the electroacupuncture group -LSB- ( @ + / - @ ) ng/mL -RSB- and the medication group -LSB- ( @ + / - @ ) ng/mL , all P < @ -RSB- .


Concerning to reducing the levels of IL-@ and TNF-alpha in serum , the results in the warm acupuncture group were superior to the other two groups ( all P < @ ) .


The warm acupuncture therapy achieves the significant efficacy on pain in postmenopausal osteoporosis , which could be related to increasing the level of IGF-@ , decreasing the levels of IL-@ and TNF-alpha , promoting bone formation and inhibting bone absorption .


Endobronchial ultrasound-guided transbronchial needle aspiration ( EBUS-TBNA ) is superior to conventional transbronchial needle aspiration ( cTBNA ) in the staging of lung cancer .


However , its efficiency in diagnosis of sarcoidosis when combined with endobronchial biopsy ( EBB ) and transbronchial lung biopsy ( TBLB ) has not been studied .


This randomized controlled trial compares diagnostic yield of EBUS-TBNA vs cTBNA in combination with EBB and TBLB .


Patients with clinical diagnosis of sarcoidosis were randomized @:@ to EBUS-TBNA or cTBNA .


All patients underwent TBLB and EBB .


The primary outcome was detection of granulomas .


The secondary end points were the individual and cumulative yields of various procedures , serious adverse events , and procedure time .


Of the @ patients , sarcoidosis was diagnosed in @ ( @ cTBNA , @ EBUS-TBNA ) .


The two groups were similar at baseline .


Granulomas were demonstrated in @ ( @ cTBNA , @ EBUS-TBNA ) patients and were similar in two groups ( @ % vs @ % , P = @ ) .


Individually , EBUS-TBNA had the highest yield ( @ of @ , @ % ) , which was better than cTBNA ( @ of @ , @ % , P = @ ) or EBB ( @ of @ , @ % , P < @ ) but not TBLB ( @ of @ , @ % , P = @ ) .


Adding EBB/TBLB to cTBNA led to an increase in granuloma detection , whereas the addition of TBLB ( but not EBB ) significantly enhanced the yield of EBUS-TBNA .


The procedure time was significantly longer with EBUS-TBNA .


No major adverse events occurred .


Individually , EBUS-TBNA has the highest diagnostic yield in sarcoidosis , but it should be combined with TBLB for the optimal yield .


The diagnostic yield of cTBNA ( plus EBB and TBLB ) is similar to EBUS-TBNA plus TBLB .


Pharmacological inhibition of the renin-angiotensin-aldosteron system ( RAAS ) may have a beneficial impact on proteinuria and chronic kidney diseases ( CKD ) progression .


Despite recent progress by means of angiotensin-converting enzyme inhibitors ( ACEI ) and angiotensin II receptor blockers ( ARB ) , there is still no optimal therapy which can stop progression of the nephropathy .


Recently introduced aliskiren is the first orally bioavailable direct renin inhibitor approved for the treatment of hypertension .


The purpose was to evaluate the extent of oxidative stress and tubular injury after the direct renin inhibitor , aliskiren compared with placebo and perindopril in patients with non-diabetic chronic kidney disease ( NDCKD ) .


A randomized , double-blind , cross-over trial was performed in @ patients receiving @mg aliskiren , @mg perindopril and placebo in random order .


The end point was a change in the urinary excretion of N-acetyl -- D-glucosaminidase ( NAG ) and @-microglobulin ( @m ) and @-F ( @ ) - isoprostane .


Aliskiren reduced excretion of @-F ( @ ) - isoprostane ( p = @ ) and @m ( p = @ ) as compared to placebo .


There were no differences between aliskiren and perindopril in this regard .


NAG urine excretion did not change after aliskiren and perindopril .


Aliskiren attenuates oxidative stress and may improve functional status of tubules in patients with NDCKD .


This phase @ study evaluated the endometrial safety of bazedoxifene ( BZA ) / conjugated estrogens ( CE ) and bone mineral density ( BMD ) effects vs BZA alone , hormone therapy , and placebo ( PBO ) .


The Selective estrogens , Menopause , And Response to Therapy ( SMART ) -@ trial was a multicenter , randomized , double-blind , PBO - and active-controlled study in postmenopausal women with an intact uterus ( N = @ ; aged @-@ years ) seeking treatment for menopausal symptoms .


Subjects received daily oral BZA @ mg/CE @ or @ mg , BZA @ mg , CE @ mg/medroxyprogesterone acetate ( MPA ) @ mg , or PBO .


Primary endpoints were incidence of endometrial hyperplasia and percent change in lumbar spine BMD at @ months .


Secondary endpoints included additional osteoporosis parameters and assessments of tolerability and safety .


At @ months , endometrial hyperplasia incidence was low ( < @ % ) and similar among groups .


The BZA/CE group showed significantly greater increases in lumbar spine and total hip BMD vs decreases with PBO ( P < @ ) ; the CE/MPA group had increased lumbar spine BMD compared with that in the BZA/CE group .


The BZA @ mg/CE @ and @ mg groups had cumulative amenorrhea rates similar to those with PBO and BZA and significantly higher than those with CE @ mg/MPA @ mg ( P < @ ) .


The incidence of breast tenderness with BZA/CE was similar to that with PBO and BZA and significantly lower than with that with CE/MPA ( P < @ ) .


Although adverse event ( AE ) rates were similar among the groups , the incidence of serious AEs overall and AE-related discontinuation rates were higher with CE/MPA than with BZA/CE , BZA , or PBO .


BZA/CE showed low rates of endometrial hyperplasia and improved lumbar spine and total hip BMD and was generally safe and well tolerated .


A pre-planned substudy of a larger multicenter randomized trial was undertaken to compare the efficacy of everolimus with reduced-dose cyclosporine in the prevention of cardiac allograft vasculopathy ( CAV ) after heart transplantation to that of mycophenolate mofetil ( MMF ) with standard-dose cyclosporine .


CAV is a major cause of long-term mortality following heart transplantation .


Everolimus has been shown to reduce the severity and incidence of CAV as measured by first year intravascular ultrasound ( IVUS ) .


MMF , in combination with cyclosporine , has also been shown to have a beneficial effect in slowing the progression of CAV .


Study patients were a pre-specified subgroup of the @-patient Everolimus versus mycophenolate mofetil in heart transplantation : a randomized , multicenter trial who underwent heart transplantation and were randomized to everolimus @ mg or MMF @ g/day .


IVUS was performed at baseline and at @ months .


Evaluable IVUS data were available in @ patients ( @ % ) .


Increase in average maximal intimal thickness ( MIT ) from baseline to month @ was significantly smaller in the everolimus @ mg group compared with the MMF group ( @ mm vs. @ mm , p < @ ) .


The incidence of CAV , defined as an increase in MIT from baseline to month @ of greater than @ mm , was @ % with everolimus versus @ % with MMF ( p = @ ) .


These findings remained irrespective of sex , age , diabetic status , donor disease , and across lipid categories .


Everolimus was significantly more efficacious than MMF in preventing CAV as measured by IVUS among heart-transplant recipients after @ year , a finding , which was maintained in a range of patient subpopulations .


CV surgery : transplantation , ventricular assistance , cardiomyopathy .


The prevalence of severe and complex obesity is increasing worldwide and surgery may offer an effective and lasting treatment .


Laparoscopic adjustable gastric band and Roux-en-Y gastric bypass surgery are the two main surgical procedures performed .


This open parallel-group randomised controlled trial will compare the effectiveness , cost-effectiveness and acceptability of gastric band ( Band ) versus gastric bypass ( Bypass ) in adults with severe and complex obesity .


It has an internal pilot phase ( in two centres ) with integrated qualitative research to establish effective and optimal methods for recruitment .


Adults with a body mass index ( BMI ) of @ kg/m@ or more , or a BMI of @ kg/m@ or more and other co-morbidities will be recruited .


At the end of the internal pilot the study will expand into more centres if the pre-set progression criteria of numbers and rates of eligible patients screened and randomised are met and if the expected rates of retention and adherence to treatment allocation are achieved .


The trial will test the joint hypotheses that Bypass is non-inferior to Band with respect to more than @ % excess weight loss and that Bypass is superior to Band with respect to health related quality of life ( HRQOL , EQ-@D ) at three years .


Secondary outcomes include other weight loss measures , waist circumference and remission/resolution of co-morbidities ; generic and symptom-specific HRQOL ; nutritional blood test results ; resource use ; eating behaviours and adverse events .


A core outcome set for reporting the results of obesity surgery will be developed and a systematic review of the evidence for sleeve gastrectomy undertaken to inform the main study design .


By-Band is the first pragmatic study to compare the two most commonly performed bariatric surgical procedures for severe and complex obesity .


The design will enable and empower surgeons to learn to recruit and participate in a randomised study .


Early evidence shows that timely recruitment is possible .


To document the effects of two doses of dexmedetomidine on the induction characteristics and dose requirements of alfaxalone .


Randomized controlled clinical trial .


Sixty one client owned dogs , status ASA I-II .


Dogs were allocated randomly into three groups , receiving as pre-anaesthetic medication , no dexmedetomidine ( D@ ) , @ g kg ( -@ ) dexmedetomidine ( D@ ) intramuscularly ( IM ) or @ g kg ( -@ ) dexmedetomidine IM ( D@ ) .


All dogs also received @ mg kg ( -@ ) methadone IM .


Level of sedation was assessed prior to induction of anaesthesia .


Induction of general anaesthesia was performed with alfaxalone administered intravenously to effect at a rate of @ mg kg ( -@ ) minute ( -@ ) ; the required dose to achieve tracheal intubation was recorded .


Anaesthesia was maintained with isoflurane in oxygen .


Cardiopulmonary parameters were recorded throughout the anaesthetic period .


Quality of intubation , induction and recovery of anaesthesia were recorded .


Quantitative data were compared with one-way anova or Kruskal-Wallis test .


Repeated measures were log-transformed and analysed with repeated measures anova ( p < @ ) .


Treatment groups were similar for categorical data , with exception of sedation level ( p < @ ) .


The doses ( mean SD ) of alfaxalone required for intubation were D@ @ @ , D@ @ @ and D@ @ @ , the difference between D@ and D@ being statistically significant ( p = @ ) .


Heart and respiratory rates during the anaesthetic period were significantly different over time and between groups ( p < @ ) ; systolic arterial blood pressure was significantly different over time ( p < @ ) but not between groups ( p = @ ) .


Induction quality and recovery scores were similar between groups ( p = @ and p = @ , respectively ) .


The administration of alfaxalone resulted in a good quality anaesthetic induction which was not affected by the dose of dexmedetomidine .


Dexmedetomidine at @ g kg ( -@ ) IM combined with methadone provides good sedation and enables a reduction of alfaxalone requirements .


To observe the clinical efficacy of multiple sclerosis ( MS ) treated with electroacupuncture and acupoint injection .


The block randomization method was used to divide @ cases into an electroacupuncture ( EA ) group and an EA + acupoint injection ( AI ) group , @ cases in each one .


In the EA group , EA was used at corresponding Jiaji ( EX-B @ ) , Weizhong ( BL @ ) , Chengshan ( BL @ ) , etc. .


In the EA + AI group , on the basis of EA , the acupoint injection of mouse nerve growth factor was supplemented .


The activity of daily life ( ADL ) and expanded disability status score ( EDSS ) were observed in the two groups before and after treatment for the evaluation of the efficacy .


The efficacy was achieved on MS after treatment in both groups ( P < @ ) .


After treatment , the scores of EDSS and Barthel index were ( @ + / - @ ) and ( @ + / - @ ) in the EA + AI group , which were better than those of ( @ + / - @ ) and ( @ + / - @ ) in the EA group ( both P < @ ) .


EA and AI co-act on reducing disability and improving the life quality in the treatment of MS and have achieved coordinately the significant effects .


Athletic taping skills are highly valued clinical competencies in the athletic therapy and training profession .


The Technical Skill Assessment Instrument ( TSAI ) has been content validated and tested for intrarater reliability .


To test the reliability of the TSAI using a more robust measure of reliability , generalizability theory , and to hypothetically and mathematically project the optimal number of raters and scenarios to reliably measure athletic taping skills in the future .


Mount Royal University .


Observational study .


A total of @ university students ( @ men , @ women ; age = @ @ years ) from the Athletic Therapy Program at Mount Royal University .


Participants were allowed @ minutes per scenario to complete prophylactic taping for a standardized patient presenting with ( @ ) a @-week-old second-degree ankle sprain and ( @ ) a thumb that had been hyperextended .


Two raters judged student performance using the TSAI .


Generalizability coefficients were calculated using variance scores for raters , participants , and scenarios .


A decision study was calculated to project the optimal number of raters and scenarios to achieve acceptable levels of reliability .


Generalizability coefficients were interpreted the same as other reliability coefficients , with @ indicating no reliability and @ indicating perfect reliability .


The result of our study design ( @ raters , @ standardized patient , @ scenarios ) was a generalizability coefficient of @ .


Decision study projects indicated that @ scenarios were necessary to reliably measure athletic taping skills .


We found moderate reliability coefficients .


Researchers should include more scenarios to reliably measure athletic taping skills .


They should also focus on the development of evidence-based practice guidelines and standards of athletic taping and should test those standards using a psychometrically sound instrument , such as the TSAI .


Nearly all clinical trials investigating patients with pulmonary arterial hypertension ( PAH ) have used the @-min walk test ( @MWT ) to evaluate exercise tolerance .


The incremental shuttle walk test ( SWT ) , however , has been proposed as a more valid and reproducible alternative to the @MWT in the evaluation of exercise tolerance in patients with chronic obstructive pulmonary disease .


The efficacy of SWT in clinical practice to evaluate the exercise capacity of patients with PAH was investigated .


The peak oxygen consumption ( pVO@ ) and oxygen consumption at anaerobic threshold ( VO@ at AT ) , the gold standard for measurement of exercise tolerance , @MWT and SWT were measured in @ clinically stable PAH patients ( WHO functional class II-III ) and the data compared .


There was a higher correlation between SWT walk distance and pVO@ than between @MWT walk distance and pVO@ ( r = @ and @ , respectively ; P < @ ) , and a higher correlation between SWT walk distance and VO@ at AT than between @MWT walk distance and VO@ at AT ( r = @ and @ , respectively ; P < @ ) .


No adverse events occurred during the exercise tests .


SWT is a better reflection than @MWT of exercise tolerance in PAH patients , and thus is a preferable alternative for assessment of exercise tolerance in PAH patients .


The development of troponin assays with increased diagnostic sensitivity and greater analytic precision has improved the diagnosis of myocardial infarction in high risk patients .


However for those patients at intermediate or low risk in whom a small troponin rise is detected , a cascade of clinical decisions and investigations could result ; potentially having uncertain impact on recurrent ischemic events and increasing bleeding risk and resource utilization .


Clinical equipoise remains as to the clinical utility of high sensitivity troponin .


We designed a pragmatic randomized clinical trial to evaluate the short and long term clinical impact and resource implications of high sensitivity @th generation troponin T reporting compared with @th generation troponin T reporting .


Two thousand patients presenting with a suspected acute coronary syndrome were randomized and risk stratified in @ metropolitan emergency departments in South Australia , Australia .


Clinical events occurring after the first @ h and within @ days were assessed as the primary endpoint with subsequent events evaluated at @ and @ months .


The true translational benefits of innovations in diagnostic testing need to be evaluated in robust clinical trials as they can be costly to introduce and the adoption process often focuses on sensitivity and specificity at the expense of measuring improvements in clinical outcome .


The results of this study will provide valuable information on contemporary patterns of troponin utilization on the heterogeneous population of chest pain patients presenting to emergency departments , while providing important information from the clinical practice setting for health administrators , government and policy makers .


Tenofovir disoproxil fumarate ( TDF ) is active against lamivudine-resistant hepatitis B virus ( HBV ) infection , but data to support its clinical efficacy in this setting are limited .


In a prospective , double-blind , @-week trial , patients were randomly assigned ( @:@ ) to groups given TDF ( @ mg , n = @ ) or a combination of emtricitabine ( FTC , @ mg ; n = @ ) and TDF ( @ mg , FTC/TDF ) .


Patients were hepatitis B e antigen ( HBeAg ) - positive or HBeAg-negative , with levels of HBV DNA @ log@ IU/mL and lamivudine resistance mutations ( HBV polymerase or reverse transcriptase amino acid substitutions rtM@I/V rtL@M by INNO-LiPA Multi-DR v@ ; Innogenetics , Inc , Alpharetta , GA ) .


The primary end point was proportion with HBV DNA < @ IU/mL ( Roche COBAS Taqman assay ; Roche Molecular Systems , Inc , Pleasanton , CA ) .


Patient groups were well matched for demographic and disease characteristics , including region ( @ % from Europe ) , HBV genotype ( @ % genotype D ) , HBeAg status ( @ % HBeAg-positive ) , and duration of lamivudine treatment ( mean , @ years ) .


At week @ of treatment , @ % of patients in the TDF group and @ % in the FTC/TDF group had levels of HBV DNA < @ IU/mL ( P = @ ) .


HBeAg loss and seroconversion did not differ between groups ; only @ patient ( @ % ) in the FTC/TDF group lost hepatitis B surface antigen .


Treatment was well tolerated ; confirmed renal events ( creatinine increase of @ mg/dL -LSB- > @ umol/L -RSB- , creatinine clearance < @ mL/min , or level of PO@ < @ mg/dL -LSB- < @ mmol/L -RSB- ) were generally mild and infrequent ( < @ % ) .


Small reductions ( < @ % ) in mean bone mineral density of hip and spine were detected by dual-energy x-ray absorptiometry in both groups .


No TDF resistance developed through @ weeks of treatment .


TDF alone is safe and effective for treatment of patients with lamivudine-resistant , chronic HBV infection .


Clinical Trials.gov No , NCT@ .


The purpose of this study was to determine whether administration of postoperative antibiotics affects the incidence of complications after primary cleft palate repair in a developing area .


This study was a prospective , double-blind , randomized , placebo-controlled trial composed of @ consecutive patients who underwent primary cleft palate repair at a single institution .


Patients were aged @ to @ years at the time of surgery ( median , @ years ) .


The patients were divided randomly into two groups .


One group received a @-day regimen of oral amoxicillin ( @ mg/kg/day ) postoperatively and the other group received placebo medication .


Both groups received a single dose of cefuroxime ( @ mg/kg ) before incision .


Patients and providers were blinded to the randomization .


Patients were followed postoperatively for early complications ( infection and wound breakdown ) and for late complications ( palatal fistulas ) .


The incidence of early complications was @ percent among the patients in the placebo group and @ percent among the patients in the antibiotic group ( p = @ ) .


Fistulas were noted in @ percent in the placebo group and in @ percent in the antibiotic group ( p = @ ) .


Logistic regression analysis identified visiting surgeons as the only covariate related to early complications ( OR , @ ; p < @ ) .


However , the use of placebo ( OR , @ ; p = @ ) , female sex ( OR , @ ; p = @ ) , and Veau III and IV ( OR , @ ; p = @ ) were observed as factors associated with the incidence of fistulas .


The authors ' results indicate that postoperative antibiotic prophylaxis can reduce the incidence of fistulas after primary cleft palate repair in a developing area .


To compare post-operative long-term complications and quality of life of two digestive reconstruction procedures after total gastrectomy .


A total of @ gastric cancer patients in Tianjin Medical University Cancer Hospital from March @ to February @ were prospectively enrolled and randomly divided into functional jejunal interposition ( FJI ) group ( @ cases ) and Roux-en-Y ( R-Y ) group ( @ cases ) .


The post-operative complications , nutritional status , and the quality of life were compared between two groups .


One , @ and @ months after operation , the incidence of R-S syndrome in FJI group was lower as compared to R-Y group -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , @ % ( @/@ ) vs. @ % ( @/@ ) , @ % ( @/@ ) vs. @ % ( @/@ ) , all P < @ -RSB- , while @ months after operation , the incidence of reflux and heartburn in FJI group was higher -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P < @ ; @ % ( @/@ ) vs. @ % ( @/@ ) , P < @ -RSB- .


There were no significant differences in quality of life questionnaire QLQ-C@ between R-Y and FJI groups .


QLQ-STO@ stomach module revealed in FJI group , the eating score was better , but reflux score was worse as compared to R-Y group @ months after operation ( all P < @ ) .


Functional jejunal interposition keeps intestinal continuity preserving and food duodenal passing , which is a reasonable digestive reconstruction procedure .


To compare central corneal swelling after eight hours of sleep in eyes wearing four different silicone hydrogel lenses with three different powers .


Twenty-nine neophyte subjects wore lotrafilcon A ( Dk , @ ) , balafilcon A ( Dk , @ ) , galyfilcon A ( Dk , @ ) and senofilcon A ( Dk , @ ) lenses in powers -@ , -@ and +@ D on separate nights , in random order , and on one eye only .


The contra-lateral eye ( no lens ) served as the control .


Central corneal thickness was measured using a digital optical pachometer before lens insertion and immediately after lens removal on waking .


For the +@ D and -@ D , lotrafilcon A induced the least swelling and galyfilcon A the most .


The +@ D power , averaged across lens materials , induced significantly greater central swelling than the -@ and -@ D ( Re-ANOVA , p < @ ) , ( @ % vs. @ % and @ % respectively ) but there was no difference between -@ and -@ D. Averaged for power , lotrafilcon A induced the least ( @ % ) and galyfilcon A the most ( @ % ) swelling at the center ( Re-ANOVA , p < @ ) .


Central corneal swelling with +@ D was significantly greater than -@ D lens power despite similar levels of average lens transmissibility of these two lens powers .


The differences in corneal swelling of the lens wearing eyes are consistent with the differences in oxygen transmission of the silicone hydrogel lenses .


In silicone hydrogel lenses central corneal swelling is mainly driven by central lens oxygen transmissibility .


Zinc deficiency is common in children among populations in developing areas .


Zinc deficiency alters the immune system and the resistance to infections .


To evaluate the effect of two zinc compounds in the prevention of acute respiratory infection and acute diarrhea .


Randomized triple-blind community trial with @ children between @-@ years of age from six child daycare centers in Medellin , Colombia .


Children were distributed in three groups receiving zinc amino acid chelate , zinc sulfate and placebo five days a week for @ weeks .


Daily symptoms of respiratory infection , acute diarrhea and side effects were evaluated .


The incidence of respiratory infection was lower with zinc amino acid chelate ( @ per @,@ child-days ) compared with placebo ( @ per @,@ child-days ) ( RR = @ , @ % CI : @ to @ , p = @ ) and with zinc sulfate ( @ per @,@ child-days ) ( RR = @ , @ % CI @ to @ , p = @ ) .


The incidence of acute diarrhea with zinc amino acid chelate ( @ per @,@ child-days ) was lower than with placebo ( @ per @,@ child-days ) ( RR = @ , @ % CI @ to @ , p = @ ) and with zinc sulfate ( @ per @,@ child-days ) ( RR = @ , @ % CI : @ to @ , p = @ ) .


Zinc amino acid chelate had a better effect in reducing the incidence of acute respiratory infection and acute diarrhea in preschool children when compared with the other groups .


For maximum effect pre-exposure prophylaxis should be targeted to the subpopulations that account for the largest proportion of infections ( population-attributable fraction -LSB- PAF -RSB- ) and for whom the number needed to treat ( NNT ) to prevent infection is lowest .


We aimed to estimate the PAF and NNT of participants in the iPrEx ( Pre-Exposure Prophylaxis Initiative ) trial .


The iPrEx study was a randomised controlled efficacy trial of pre-exposure prophylaxis with coformulated tenofovir disoproxil fumarate and emtricitabine in @ men who have sex with men ( MSM ) and transgender women .


Participants aged @ years or older who were male at birth were enrolled from @ trial sites in Brazil , Ecuador , Peru , South Africa , Thailand , and the USA .


Participants were randomly assigned ( @:@ ) to receive either a pill with active pre-exposure prophylaxis or placebo , taken daily .


We calculated the association between demographic and risk behaviour during screening and subsequent seroconversion among placebo recipients using a Poisson model , and we calculated the PAF and NNT for risk behaviour subgroups .


The iPrEx trial is registered with ClinicalTrials.gov , NCT@ .


Patients were enrolled between July @ , @ , and Dec @ , @ , and were followed up until Nov @ , @ .


Of the @ MSM and transgender women in the iPrEx trial , @ were assigned to pre-exposure prophylaxis and @ to placebo .


@ of @ patients in the placebo group became infected with HIV during follow-up .


Participants reporting receptive anal intercourse without a condom seroconverted significantly more often than those reporting no anal sex without a condom ( adjusted hazard ratio -LSB- AHR -RSB- @ , @ % CI @-@ ) .


The overall PAF for MSM and transgender women reporting receptive anal intercourse without a condom was @ % ( prevalence @ % ) .


Most of this risk came from receptive anal intercourse without a condom with partners with unknown serostatus ( PAF @ % , prevalence @ % , AHR @ , @ % CI @-@ ) ; by contrast , the PAF for receptive anal intercourse without a condom with an HIV-positive partner was @ % ( prevalence @ % , AHR @ , @ % CI @-@ ) .


The overall NNT per year for the cohort was @ ( @ % CI @-@ ) .


NNTs were lowest for MSM and transgender women self-reporting receptive anal intercourse without a condom ( NNT @ ) , cocaine use ( @ ) , or a sexually transmitted infection ( @ ) .


Having one partner and insertive anal sex without a condom had the highest NNTs ( @ and @ , respectively ) .


Pre-exposure prophylaxis may be most effective at a population level if targeted toward MSM and transgender women who report receptive anal intercourse without a condom , even if they perceive their partners to be HIV negative .


Substance use history and testing for STIs should also inform individual decisions to start pre-exposure prophylaxis .


Consideration of the PAF and NNT can aid in discussion of the benefits and risks of pre-exposure prophylaxis with MSM and transgender women .


Epidermal growth factor receptor ( EGFR ) mutation testing is standard practice after lung adenocarcinoma diagnosis , and provision of high-quality tumor tissue is ideal .


However , there are knowledge gaps regarding the utility of cytology or low tumor content histology samples to establish EGFR mutation status , particularly with regard to the proportion of testing performed using these sample types , and the lack of an established link with efficacy of treatment .


The randomized phase III Iressa Pan-ASia Study ( IPASS ; ClinicalTrials.gov identifier NCT@ ) of first-line gefitinib versus chemotherapy analyzed samples meeting preplanned specifications ( n = @ evaluable for EGFR mutation ; n = @ mutation-positive ) .


This supplementary analysis assessed tumor content and mutation status of histology ( n = @ ) and cytology samples ( n = @ ) which were previously unanalyzed due to sample quality , type , and tumor content ( < @ cells ) .


Objective response rate ( ORR ) and change in tumor size with gefitinib treatment were assessed .


EGFR mutation testing was successful in @ % and @ % of previously unanalyzed histology and cytology samples , respectively .


Mutations were detected in @ tumors previously described as mutation-unknown ( histology , n = @ ; cytology , n = @ ) .


ORRs in mutation-positive cytology ( @ % ) and histology ( @ % ) subgroups were consistent with previous analyses ( @ % ) .


Tumor size decrease was consistent across previously analyzed and unanalyzed samples ( all mutation subgroups ) , with less consistency across ORRs in mutation-negative cytology ( @ % ) and histology ( @ % ) subgroups versus the previous analysis ( @ % ) .


Histology samples with low tumor content and cytology samples can be used for EGFR mutation testing ; patients whose mutation status was confirmed using these sample types achieved a response to treatment consistent with those confirmed using high-quality histology samples .


Better sample quantity/quality can potentially reduce false-negative results .


The main objective was to evaluate two models of care for children and adolescents requiring hospitalization due to severe mental illness .


Model @ : early discharge followed by a newly established home treatment service enhanced by clinical elements according to need ( BeZuHG ) ; Model @ : admission to an inpatient unit ( TAU ) .


@ children and adolescents admitted to inpatient care were randomized to either a control group ( regular inpatient stay ) or an intervention group ( BeZuHG group ) .


Sociodemographic data , ICD-@ and DSM-IV diagnoses , health and social functioning , psychopathology , clinical impairment , and service use were assessed pre - and posttreatment regarding effectiveness , outcome , contact time , and acceptance within the families .


Clinical outcome in BeZuHG treatment was as effective as inpatient care .


There was a good acceptance within the families , family resources enhanced treatment outcome , and a significant reduction in length of inpatient stay could be shown .


The BeZuHG model should be a regular option in child and adolescent psychiatric care .


Further rigorous evaluation of the model is required : A @-year follow-up investigating the stability of the shown effects is planned .


Examine how different dosing schedules and recent stimulant therapy effect incidence , time to onset , and duration of common treatment-emergent adverse events ( TEAEs ) during atomoxetine treatment .


Post hoc analyses including safety data ( open-ended questions ) from @ pediatric and @ adult atomoxetine trials ( @-@ ) in patients with attention-deficit/hyperactivity disorder .


Most common TEAEs were determined by incidence rates and frequency of consumer and clinician inquiries .


Onset and duration of TEAEs with slow versus fast titration , once-daily versus twice-daily dosing , and previous stimulant exposure were compared among treatment groups using Kaplan-Meier methods .


In pediatric patients , the most commonly reported TEAEs were abdominal pain , decreased appetite , fatigue , nausea , somnolence , and vomiting ; time to onset of TEAEs was significantly shorter for once-daily versus twice-daily dosing for all TEAEs ( P @ ) and for fast versus slow titration for abdominal pain , decreased appetite , and somnolence ( all P values @ ) ; duration of TEAEs with once-daily dosing was significantly longer for decreased appetite ( P = @ ) and nausea ( P = @ ) ; and more common in stimulant-naive patients versus patients with prior stimulant use were abdominal pain , decreased appetite , and fatigue ( P @ ) .


In adult patients , the most commonly reported TEAEs ( erectile dysfunction data were excluded ) were nausea , insomnia , decreased appetite , urinary hesitation/urinary retention , and fatigue ; insomnia had a significantly shorter time to onset and longer duration with twice-daily versus once-daily dosing ( P @ ) and fast versus slow titration ( P @ ) .


Time to onset and resolution of TEAEs appear dependent on dosing schedule and titration speed .


These findings can help to better manage tolerability issues and set appropriate expectations for clinicians and patients during atomoxetine titration , potentially improving treatment adherence and success .


To investigate the renoprotective effect of nicardipine in patients with pre-existing renal insufficiency undergoing robot-assisted laparoscopic radical prostatectomy ( RALRP ) .


Men with preoperative renal insufficiency ( estimated glomerular filtration rate -LSB- eGFR -RSB- < @ ml/min per @ m ( @ ) ) were enrolled and randomized to receive either @ g/kg per min nicardipine continuous infusion ( nicardipine group ) or normal saline ( control group ) during RALRP .


Renal function was determined by eGFR and serum creatinine concentration .


Serum creatinine levels on postoperative days ( POD ) @ and @ were significantly lower than baseline values in the nicardipine group ( n = @ ) .


In the control group ( n = @ ) , eGFR was significantly higher on POD @ than baseline , and was significantly higher than baseline on POD @ and @ in the nicardipine group .


The change in eGFR from baseline to POD @ was significantly higher in the nicardipine group than the control group .


Continuous infusion of nicardipine during RALRP improved postoperative renal function on POD @ in patients with pre-existing renal insufficiency .


There are few comparative studies about the optimal method of pneumatic compression to prevent deep vein thrombosis ( DVT ) .


The aim of this prospective randomized study was to compare venous hemodynamic changes and their clinical influences between two graded sequential compression groups ( an alternate sequential compression device -LSB- ASCD -RSB- vs. a simultaneous sequential compression device -LSB- SSCD -RSB- ) .


In total , @ patients ( @ limbs ) undergoing knee and spine operations were prospectively randomized into two device groups ( ASCD vs. SSCD groups ) .


Duplex ultrasonography examinations were performed on the @th and @th postoperative days for the detection of DVT and the evaluation of venous hemodynamics .


Continuous data for the two groups were analyzed using a two-tailed , unpaired t-test .


Relative frequencies of unpaired samples were compared using Fisher exact test .


Mixed effects models that might be viewed as ANCOVA models were also considered .


DVT developed in @ patients ( @ % ) , all of whom were asymptomatic for isolated calf DVTs .


Two of these patients were from the ASCD group ( @ % ) and the other five were from the SSCD group ( @ % ) , but there was no significant difference ( p = @ ) .


Baseline peak velocity , mean velocity , peak volume flow , and total volume flow were enhanced significantly in both device groups ( p < @ ) .


However , the degrees of flow and velocity enhancement did not differ significantly between the groups .


The accumulated expelled volumes for an hour were in favor of the ASCD group .


Both graded sequential compression devices showed similar results both in clinical and physiological efficacies .


Further studies are required to investigate the optimal intermittent pneumatic compression method for enhanced hemodynamic efficacy and better thromboprophylaxis .


Although the local response induced by acupuncture manipulation has been considered to be among the important factors that induce the effects of acupuncture , this connection has not yet been properly studied with standardized tools .


The aims of this study are to examine the local changes in microcirculation that occur at different manipulation intensities and explore any associations of these changes with the analgesic effects of acupuncture .


Twelve healthy volunteers received three acupuncture interventions ( insertion only , a single manipulation , and repeated manipulations ) at the right LI@ ( Hegu or Hapgok ) in random order .


Skin blood perfusion was measured in a @-mm ( @ ) area ellipse centered on LI@ by using laser Doppler perfusion imaging ( LDPI ) before , during , and after acupuncture stimulation .


Pressure pain thresholds ( PPTs ) were measured at ipsilateral areas , including acupoints ST@ ( abdomen ) , LI@ ( hand ) , LI@ ( arm ) , and SP@ ( leg ) .


Repeated acupuncture manipulations enhanced microcirculatory perfusion compared with the insertion-only ( p < @ ) and the single-manipulation ( p < @ ) conditions .


The repeated acupuncture manipulations significantly decreased the pressure pain at ST@ compared with the other groups ( each p < @ ) .


Of note , Spearman correlation analysis revealed significant correlation between changes of local perfusion and PPTs ( r = @ ; p = @ ) .


These results suggested that repeated manipulation induced higher local microcirculatory changes that were correlated with the analgesic effects at the relevant sites .


The findings suggest that a proper dose of acupuncture stimulation might be essential to elicit the acupuncture effects .


The dose-response relationship between doxorubicin and superabsorbent drug-eluting microspheres has not been established .


In this study , we investigated the relationships between dose and delivery parameters as they pertain to toxicity and response in surgically resectable hepatocellular carcinoma ( HCC ) .


Twenty-five patients with resectable HCC were randomly assigned and divided into four groups , each receiving either bland , @ mg , @ mg or @ mg of doxorubicin loaded Super Absorbent Polymer microspheres , with @ patients undergoing surgical resection .


Response Evaluation and Criteria in Solid Tumors ( RECIST ) @ and European Association for the Study of the Liver ( EASL ) - based volumetric response was performed at one month and surgical resection of the reference tumor was performed at two months .


Adverse events were collected at regular intervals .


Fifty-six percent of patients demonstrated complete response according to EASL criteria as opposed to @ % according to RECIST ( v@ @ ) criteria .


Residual tumor was identified in all groups ( @ mg : @ % @ % ; @ mg : @ % @ % ; @ mg : @ % @ % ; and @ mg : @ % @ % .


A total of @ adverse events of grades @-@ occurred ( average @ per patient ) , with no grade @ or @ .


No difference was noted between bland embolic and drug-loaded groups .


Subset analysis did demonstrate a significantly increased degree of necrosis in the @ mg-loaded group ( p = @ ) .


Strong correlation existed between arterial phase Computer Tomography EASL-based response and histopathology ( r = @ ; p < @ ) .


All groups had residual tumor .


Histology correlates strongly with one-month post-procedural imaging and response optimized at @ mg of loading per vial .


Adverse events were a reflection of embolization , with no relationship between loading dose or administered dose of doxorubicin .


Increased systolic blood pressure variability between outpatient visits is associated with increased incidence of cardiovascular end points .


However , few studies have examined the association of visit-to-visit variability in systolic blood pressure with clinically relevant kidney disease outcomes .


We analyzed the association of systolic blood pressure visit-to-visit variability with renal and cardiovascular morbidity and mortality among individuals with diabetes and nephropathy .


Observational analysis of IDNT ( Irbesartan Diabetic Nephropathy Trial ) and the RENAAL ( Reduction of End Points in Non-Insulin-Dependent Diabetes With the Angiotensin II Antagonist Losartan ) Study .


@,@ participants with type @ diabetes and nephropathy with at least @ year of blood pressure measurements available .


Systolic blood pressure visit-to-visit variability was calculated from the SD of the systolic blood pressure from @ visits occurring @-@ months postrandomization .


The kidney disease outcome was defined as time to confirmed doubling of serum creatinine level , end-stage renal disease , or death ; the cardiovascular outcome was defined as time to cardiovascular death , myocardial infarction , stroke , hospitalization for heart failure , or revascularization .


Mean visit-to-visit variability in systolic blood pressure from @ to @ months postrandomization was @ ( SD ) mmHg .


Following this ascertainment period , there were @ kidney disease and @ cardiovascular events .