Alirocumab , a monoclonal antibody that inhibits proprotein convertase subtilisin-kexin type 9 ( PCSK9 ) , has been shown to reduce low-density lipoprotein ( LDL ) cholesterol levels in patients who are receiving statin therapy .


Larger and longer-term studies are needed to establish safety and efficacy .


We conducted a randomized trial involving 2341 patients at high risk for cardiovascular events who had LDL cholesterol levels of 70 mg per deciliter ( 1.8 mmol per liter ) or more and were receiving treatment with statins at the maximum tolerated dose ( the highest dose associated with an acceptable side-effect profile ) , with or without other lipid-lowering therapy .


Patients were randomly assigned in a 2:1 ratio to receive alirocumab ( 150 mg ) or placebo as a 1-ml subcutaneous injection every 2 weeks for 78 weeks .


The primary efficacy end point was the percentage change in calculated LDL cholesterol level from baseline to week 24 .


At week 24 , the difference between the alirocumab and placebo groups in the mean percentage change from baseline in calculated LDL cholesterol level was -62 percentage points ( P < 0.001 ) ; the treatment effect remained consistent over a period of 78 weeks .


The alirocumab group , as compared with the placebo group , had higher rates of injection-site reactions ( 5.9 % vs. 4.2 % ) , myalgia ( 5.4 % vs. 2.9 % ) , neurocognitive events ( 1.2 % vs. 0.5 % ) , and ophthalmologic events ( 2.9 % vs. 1.9 % ) .


In a post hoc analysis , the rate of major adverse cardiovascular events ( death from coronary heart disease , nonfatal myocardial infarction , fatal or nonfatal ischemic stroke , or unstable angina requiring hospitalization ) was lower with alirocumab than with placebo ( 1.7 % vs. 3.3 % ; hazard ratio , 0.52 ; 95 % confidence interval , 0.31 to 0.90 ; nominal P = 0.02 ) .


Over a period of 78 weeks , alirocumab , when added to statin therapy at the maximum tolerated dose , significantly reduced LDL cholesterol levels .


In a post hoc analysis , there was evidence of a reduction in the rate of cardiovascular events with alirocumab .


( Funded by Sanofi and Regeneron Pharmaceuticals ; ODYSSEY LONG TERM ClinicalTrials.gov number , NCT01507831 . )


The relationship between lower urinary tract symptoms ( LUTS ) and erectile dysfunction ( ED ) has recently received increased attention .


The aim of this study was to evaluate the efficacy of the Alfa-5 association of Serenoa repens , Pinus massoniana Bark Extract ( PMBE ) and Crocus sativus ( IDIProst Gold ) in improvement of patient 's quality of life , when compared with Serenoa repens alone .


All patients with clinical and instrumental diagnosis of LUTS due to Benign Prostatic Hyperplasia ( BPH ) and ED , attending 5 Italians Urological Institutions from May to December 2012 were enrolled in this prospective , multicentre , phase 3 study .


Participants were assigned to receive oral capsules of IDIProst Gold ( one capsule q24 h ) or Serenoa repens 320 mg ( one capsule q24h ) for 3 months .


Clinical and instrumental analyses were carried out at the enrollment and at the end of therapy .


IPSS , IIEF-5 and SF-36 questionnaires have been used .


The main outcome measure was the improvement of quality of life at the end of the whole study period .


129 ( mean age 45-71 4.36 ) men were randomly allocated to IDIProst Gold ( n = 83 ) or Serenoa repens ( n = 46 ) .


The baseline questionnaire mean scores were 17.1 6.4 , 14.9 3.7 , 96.3 1.2 for IPSS , IIEF-5 and SF-36 , respectively .


At the follow-up examination , statistically significant differences have been reported in terms of IPSS ( 11.9 vs 13.8 ; p < 0.001 ) , IIEF-5 and SF-36 mean scores ( 19.3 vs 16.1 ; 99.7 vs 96.3 ; p < 0.003 ; p < 0.001 ) .


Moreover , statistically significant differences were then reported between the two visits , in terms of IPSS , IIEF-5 and SF-36 scores ( p < 0.003 ; p < 0.001 ; p < 0.001 ) , only in the IDIProst Gold group .


In conclusions , we found that IDIProst Gold significantly improve the quality of life of patients affected by LUTS due to BPH and ED , specifically in terms of sexual function , highlighting that a better sexual quality of life is correlated with an higher overall quality of life regardless of the urinary function .


The aim of this study was to evaluate efficacy and safety of gemcitabine plus S-1 ( GS ) combination chemotherapy in patients with unresectable pancreatic cancer .


Patients were randomly assigned to receive GS ( oral S-1 60mg/m ( 2 ) daily on days 1-15 every 3weeks and gemcitabine 1,000 mg/m ( 2 ) on days 8 and 15 ) or gemcitabine ( 1,000 mg/m ( 2 ) on days 1 , 8 , and 15 every 4weeks ) .


The primary endpoint was progression-free survival ( PFS ) .


One hundred and one patients were randomly assigned .


PFS was significantly longer in the GS arm with an estimated hazard ratio ( HR ) of 0.65 ( 95 % CI 0.43-0 .98 ; P = 0.039 ; median 5.3 vs 3.8 months ) .


Objective response rate ( ORR ) was also better in the GS arm ( 21.6 vs 6 % , P = 0.048 ) .


Median survival was 8.6 months for GS and 8.6 months for GEM ( HR 0.93 ; 95 % CI 0.61-1 .41 ; P = 0.714 ) .


Grade 3-4 neutropenia ( 44 vs 19.6 % , P = 0.011 ) and thrombocytopenia ( 26 vs 8.7 % , P = 0.051 ) were more frequent in the GS arm .


GS therapy improved PFS and ORR with acceptable toxicity profile in patients with unresectable pancreatic cancer .


Few studies targeting obesity in serious mental illness have reported clinically significant risk reduction , and none have been replicated in community settings or demonstrated sustained outcomes after intervention withdrawal .


The authors sought to replicate positive health outcomes demonstrated in a previous randomized effectiveness study of the In SHAPE program across urban community mental health organizations serving an ethnically diverse population .


Persons with serious mental illness and a body mass index ( BMI ) > 25 receiving services in three community mental health organizations were recruited and randomly assigned either to the 12-month In SHAPE program , which included membership in a public fitness club and weekly meetings with a health promotion coach , or to fitness club membership alone .


The primary outcome measures were weight and cardiorespiratory fitness ( as measured with the 6-minute walk test ) , assessed at baseline and at 3 , 6 , 9 , 12 , and 18 months .


Participants ( N = 210 ) were ethnically diverse ( 46 % were nonwhite ) , with a mean baseline BMI of 36.8 ( SD = 8.2 ) .


At 12 months , the In SHAPE group ( N = 104 ) had greater reduction in weight and improved fitness compared with the fitness club membership only group ( N = 106 ) .


Primary outcomes were maintained at 18 months .


Approximately half of the In SHAPE group ( 51 % at 12 months and 46 % at 18 months ) achieved clinically significant cardiovascular risk reduction ( a weight loss 5 % or an increase of > 50 meters on the 6-minute walk test ) .


This is the first replication study confirming the effectiveness of a health coaching intervention in achieving and sustaining clinically significant reductions in cardiovascular risk for overweight and obese persons with serious mental illness .


Allograft safety is contingent on effective sterilization .


However , current sterilization methods have been associated with decreased biomechanical strength and higher failure rates of soft-tissue allografts .


In this study , electron beam ( e-beam ) sterilization was explored as an alternative sterilization method to preserve biomechanical integrity .


We hypothesized that e-beam sterilization would not significantly alter the biomechanical properties of tendon allograft compared with aseptic , nonsterilized controls and gamma-irradiated grafts .


Separate sets of forty fresh-frozen tibialis tendon allografts ( four from each of ten donors ) and forty bisected bone-patellar tendon-bone ( BTB ) allografts ( four from each of ten donors ) were randomly assigned to four study groups .


One group received a 17.1 to 21.0-kGy gamma radiation dose ; two other groups were sterilized with an e-beam at either a high ( 17.1 to 21.0-kGy ) or low ( 9.2 to 12.2-kGy ) dose .


A fourth group served as nonsterilized controls .


Each graft was cyclically loaded to 200 N of tension for 2000 cycles at a frequency of 2 Hz , allowed to relax for five minutes , and then tested in tension until failure at a 100 % / sec strain rate .


One-way analysis of variance testing was used to identify significant differences .


Tibialis tendons sterilized with both e-beam treatments and with gamma irradiation exhibited values for cyclic tendon elongation , maximum load , maximum displacement , stiffness , maximum stress , maximum strain , and elastic modulus that were not significantly different from those of nonsterilized controls .


BTB allografts sterilized with the high e-beam dose and with gamma irradiation were not significantly different in cyclic tendon elongation , maximum load , maximum displacement , stiffness , maximum stress , maximum strain , and elastic modulus from nonsterilized controls .


BTB allografts sterilized with the e-beam at the lower dose were significantly less stiff than nonsterilized controls ( p = 0.014 ) but did not differ from controls in any other properties .


The difference in stiffness likely resulted from variations in tendon size rather than the treatments , as the elastic moduli of the groups were similar .


The biomechanical properties of tibialis and BTB allografts sterilized with use of an e-beam at a dose range of 17.1 to 21.0 kGy were not different from those of aseptic , nonsterilized controls or gamma-irradiated allografts .


E-beam sterilization can be a viable method to produce safe and biomechanically uncompromised soft-tissue allografts .


Angular stable locking of intramedullary nails has been shown to enhance fixation stability of tibial fractures in biomechanical and animal studies .


The aim of our study was to assess whether use of the angular stable locking system or conventional locking resulted in earlier full weight-bearing with minimum pain for patients with a distal tibial fracture treated with an intramedullary nail .


A prospective multicenter , randomized , patient-blinded trial was conducted with adults who had a distal tibial fracture .


Patients ' fractures were managed with an intramedullary nail locked with either an angular stable locking system or conventional locking screws .


Outcomes were evaluated at six weeks , twelve weeks , six months , and one year after surgery .


Time to full weight-bearing with minimum pain was calculated with use of daily entries from patient diaries .


Secondary outcomes included pain at the fracture site under load , quality of life , gait analysis , mobility , radiographic findings , and adverse events .


One hundred and forty-two patients were randomly allocated to two treatment groups : seventy-five to the group receiving intramedullary nailing with the angular stable locking system and sixty-seven to the group receiving conventional intramedullary nailing .


No clinically important differences were found for either the primary or secondary outcome parameters between the groups during the entire follow-up period .


Use of an angular stable locking system with intramedullary nailing did not improve the outcome compared with conventional locking screws in the treatment of distal tibial fractures .


Ridge preservation protocols reduce crestal remodeling after tooth extraction .


There is insufficient evidence on bone grafting in combination with platelet-rich plasma ( PRP ) or recombinant human platelet-derived growth factor ( rhPDGF-BB ) .


The aim of this study is to evaluate healing of grafted and nongrafted sockets and the effect of PRP and rhPDGF-BB on early remodeling .


Forty-one patients whose treatment plan included extraction of anterior or premolar teeth were randomized into four groups .


Group 1 : collagen plug ( control ) .


Group 2 : mineralized freeze-dried bone allograft ( FDBA ) / - tricalcium phosphate ( - TCP ) / collagen plug .


Group 3 : FDBA / - TCP/PRP/collagen plug .


Group 4 : FDBA / - TCP/rhPDGF-BB/collagen plug .


At 8 weeks , a core was harvested from the center of 41 sockets .


Histomorphometric analysis took place .


Differences were analyzed using one-way analysis of variance ( ANOVA ) or chi-square tests for continuous and categorical data .


Pairwise comparisons were tested using least squares means .


Spearman correlation coefficients were used to evaluate the relationship of bone growth with potential confounders .


A P value < .05 was considered statistically significant .


ANOVA did not indicate statistical significance in age , gender , smoking , ethnicity , or race distribution .


Significant differences in tissue distribution were identified between groups and between different thirds of harvested core .


More new bone and amorphous organic matrix was noted in the control group .


In sites where bone graft was combined with growth factors , the amount of residual particles was less than in sites where bone graft was used alone .


Inclusion of bone replacement graft suppressed new bone formation during early healing .


Inclusion of PRP and rhPDGF-BB produced less residual bone graft material , indicating more rapid turnover of bone graft .


All treatment modalities achieved a significant amount of new vital bone at 8 weeks postextraction .


To investigate in this phase 2a study ( ZENITH ) the safety , tolerability , and antiviral activity of VX-222 , a selective , non-nucleoside inhibitor of hepatitis C virus ( HCV ) NS5B polymerase , combined with various telaprevir-based regimens for treatment of genotype 1 HCV .


In total , 152 treatment-naive patients received VX-222 + telaprevir ( ` DUAL ' regimen ; n = 47 ) , with ribavirin ( ` TRIPLE ' regimen ; n = 46 ) , or with peginterferon + ribavirin ( ` QUAD ' regimen ; n = 59 ) for 12 weeks .


Patients with detectable HCV RNA at weeks 2 and/or 8 received peginterferon + ribavirin for 24 ( DUAL and TRIPLE ) or 12 ( QUAD ) additional weeks .


VX-222 ( 100 or 400 mg twice daily ) was well tolerated , with an increased rate of gastrointestinal adverse events observed with the higher dose .


Across VX-222 400-mg twice-daily regimens , the QUAD was associated with the highest frequency of grade 3/4 adverse events .


The DUAL was discontinued because of high viral breakthrough before week 12 .


Sustained virologic response ( SVR ) 24 weeks after end of treatment ( SVR24 ) , including patients treated with 12 or 24 additional weeks of peginterferon + ribavirin , was 67 % for TRIPLE ( VX-222 400 mg twice daily ) and 79 and 90 % for QUAD ( VX-222 100 and 400 mg twice daily , respectively ) .


These results provide valuable information regarding the safety , tolerability , and efficacy of telaprevir combined with a non-nucleoside polymerase inhibitor , as dual therapy or with ribavirin without or with peginterferon .


Telaprevir and VX-222 , alone or with ribavirin without or with peginterferon , were generally well tolerated , with improved tolerability without peginterferon .


SVR24 rates achieved with TRIPLE and QUAD regimens containing telaprevir and VX-222 were comparable to those observed with telaprevir-based therapy .


Remote ischemic preconditioning may result in reduction in infarct size during percutaneous coronary intervention ( PCI ) .


It is unclear whether remote ischemic postconditioning ( RIPost ) will reduce the incidence of myocardial injury after PCI , and whether ischemic conditioning of a larger remote organ ( thigh versus arm ) would provide further myocardial protection .


We randomized 360 patients presenting with stable or unstable angina ( 28 % of patients ) and negative Troponin T at baseline to 3 groups : 2 groups received RIPost ( induced by ischemia to upper or lower limb ) , and a third was the control group .


RIPost was applied during PCI immediately after stent deployment , by three 5-minute cycles of blood pressure cuff inflation to > 200 mmHg in the arm or thigh ( 20 mmHg in the control ) with 5-minute breaks between each cycle .


The primary end-point was the proportion of patients with Troponin T levels > 3ULN postprocedure ( at 6 or 18-24 hours ) , where ULN stands for upper limit of normal .


A total of 120 patients were randomized to each group .


There were no differences in baseline characteristics between the 3 groups .


The primary outcome occurred in 30 % , 35 % , and 35 % of the arm , thigh , and control groups , respectively ( P = 0.64 ) .


There were no differences in creatine kinase or high sensitivity C-reactive protein levels after PCI or in the incidence of acute kidney injury between the groups .


RIPost during PCI did not reduce the incidence of periprocedural myocardial injury .


Similar effect was obtained when remote ischemia was induced to the upper or lower limb .


http://www.clinicaltrials.gov .


Unique identifier : NCT00970827 .


The term angiokeratoma refers to a group of unrelated diseases with similar histopathologic features .


Four clinical variants of angiokeratoma have been described .


However , it is not known whether some variants of angiokeratoma are of lymphatic origin , and an immunohistochemical study of lymphatic markers has not been previously performed .


We performed an immunohistochemical study of angiokeratomas using lymphatic markers .


Fifteen cases of angiokeratoma corporis diffusum , 10 cases of Fordyce angiokeratoma , 10 cases of Mibelli angiokeratoma and 10 cases of solitary angiokeratoma were examined by immunohistochemical analysis using CD31 , D2-40 , Prox1 and Wilms ' tumor 1 ( WT-1 ) .


The vessels of angiokeratoma corporis diffusum , Fordyce angiokeratoma and solitary angiokeratoma were usually focally positive for D2-40 and positive for Prox1 , whereas the vessels of Mibelli angiokeratoma were negative for D2-40 and positive for Prox1 .


The results suggest lymphatic derivation of angiokeratoma corporis diffusum , Fordyce angiokeratoma and solitary angiokeratoma .


However , the derivation of Mibelli angiokeratoma could not be determined based on the present immunohistochemical results .


The purpose of this research was to replicate a successful intervention to increase physical activity in a different region of the country , and explore genetic and physiological moderators of intervention efficacy drawn from a transdisciplinary theoretical framework .


A randomized controlled trial comparing a print-based physical activity intervention ( COSTRIDE ) to a print-based health and wellness contact control ( HW ) intervention was conducted .


Sedentary participants ( n = 219 ) completed assessments at baseline and follow-up assessments at 3 , 6 , 9 , and 12months following the initiation of the intervention .


Participants in both conditions significantly increased exercise behavior in the first six months , and then leveled off or decreased physical activity in the second six months of the study .


Those in the COSTRIDE intervention increased significantly more than those in the HW intervention , and were better able to maintain their exercise behavior .


Genetic factors ( BDNF , rs6265 ; FTO , rs8044769 ) , but not selected physiological ( body temperature , blood lactate , systolic blood pressure , plasma norepinephrine , and heart rate ) or subjective ( perceived pain , affect ) responses to physical activity , moderated response to the intervention .


There are underlying genetic factors that influence response to behavioral intervention , and a better understanding of these factors has the potential to influence the development , targeting and tailoring of behavioral interventions to increase physical activity .


Clinicaltrials.gov registration : NCT01091857 .


Subcuticular closure provides a superior cosmetic result in clean wounds .


The aim of this work was to investigate the safety in terms of postoperative infection and cosmetic effectiveness of subcuticular wound closure after elective colon cancer surgery in clean-contaminated wounds .


Patients who underwent elective resection of colon cancer were randomized to interrupted subcuticular and interrupted transdermal suture groups .


The large bowel was prepared by mechanical washout with polyethylene glycol .


All patients received metronidazole and kanamycin orally and flomoxef sodium once parenterally for antimicrobial prophylaxis .


The primary end point was the incidence of incisional surgical-site infections within 30 days after operation .


We assessed noninferiority of subcuticular suture within a margin of 10 % .


Analysis was by intent-to-treat .


Secondary objectives include comparison of wound closure time , comfort , and cosmesis of the scar and satisfaction of patients .


This study was registered with UMIN-CTR , UMIN000003005 .


A total of 293 patients were randomized to the two groups .


Incisional surgical-site infection rates were 11.0 % ( 90 % confidence interval 7.0-16 .3 % ) for both groups .


The relative risk of subcuticular suture was 1.00 ( 0.58-1 .73 , one-tail P = .57 ) .


Interrupted subcuticular suture was noninferior to interrupted transdermal suture ( P = .0088 ) .


Throughout 6 months after operation , patients expressed a significant preference for the subcuticular suture technique , noting rapid relief from pain , decreased vascularity , and smaller width , although the procedure took twice as long .


Subcuticular suture did not increase the incidence of wound complications in elective colon cancer operation .


Patients preferred a technique of interrupted subcuticular closure , citing better cosmetic results , and less pain .


Life-threatening ear , nose , and throat ( ENT ) emergencies are uncommon but require immediate skilled management .


We investigated if traditional lecture-based teaching can be improved by a simulation and lecture hybrid approach .


A single-blinded , prospective , randomized controlled trial .


Two groups of interns with no previous ENT experience were randomized to one of two training groups : a simulation/lecture hybrid group or a lecture-only control group .


Both groups received 90 minutes of training covering the assessment of critically ill patients and four ENT emergency topics .


Both groups received the same initial lecture slides .


The control group received additional slides , and the simulation group received simulated emergency scenario training using basic mannequins .


Following the training , candidates were asked to provide feedback on their perception of training , and they were formally assessed with a standardized one-to-one viva .


Thirty-eight interns were recruited : 18 in the control group and 20 in the simulation group .


The candidates in the simulation group performed significantly better in all viva situations ( P < .05 ) and had better perception of learning ( P < .05 ) .


Additionally , the simulation group was more likely to recommend the training to a colleague ( P < .05 ) .


We have demonstrated that replacing traditional lecture-based training with a mixture of lectures and emergency scenario simulation is more effective at preparing junior doctors for ENT emergencies , and better met their learning needs .


Implementing this kind of teaching is feasible with a minimum of additional resources or time .


Polycystic ovary syndrome ( PCOS ) is characterized by obesity and insulin resistance ( IR ) , which result in elevated plasminogen activator inhibitor-1 ( PAI-1 ) levels .


We aimed to assess the changes in PAI-1 levels in PCOS during treatment with metformin and during weight loss .


Twenty-three normal weight women with PCOS were given metformin 850 mg bid for 6 months .


Fifty overweight/obese women with PCOS were prescribed an energy-restricted diet , were instructed to exercise and were randomized to orlistat 120 mg tid or sibutramine 10 mg qd for 6 months .


In normal weight women , treatment with metformin reduced the body mass index ( BMI ) and circulating androgens , improved markers of IR and lowered PAI-1 levels .


In overweight/obese women , sibutramine and orlistat yielded comparable reductions in BMI and markers of IR .


In contrast , the effects on the free androgen index ( FAI ) differed ( p = 0.027 ) : sibutramine reduced the FAI ( p = 0.005 ) , whereas orlistat had no effect .


The effects of sibutramine and orlistat on PAI-1 levels also differed ( p = 0.042 ) : sibutramine reduced PAI-1 levels ( p < 0.001 ) , whereas orlistat had no effect .


Metformin and sibutramine , but not orlistat , reduce PAI-1 levels in PCOS .


The reduction in circulating androgens during metformin and sibutramine treatment might be implicated in this decline .


There are limited data on the extent of blood-brain barrier ( BBB ) compromise in acute intracerebral hemorrhage patients .


We tested the hypotheses that BBB compromise measured with permeability-surface area product ( PS ) is increased in the perihematoma region and predicts perihematoma edema growth in acute intracerebral hemorrhage patients .


Patients were randomized within 24 hours of symptom onset to a systolic blood pressure ( SBP ) treatment of < 150 ( n = 26 ) or < 180 mm Hg ( n = 27 ) .


Permeability maps were generated using computed tomographic perfusion source data acquired 2 hours after randomization , and mean PS was measured in the hematoma , perihematoma , and hemispheric regions .


Hematoma and edema volumes were measured on noncontrast computed tomographic scans obtained at baseline , 2 hours and 24 hours after randomization .


Patients were randomized at a median ( interquartile range ) time of 9.3 hours ( 14.1 ) from symptom onset .


Treatment groups were balanced with respect to baseline SBP and hematoma volume .


Perihematoma PS ( 5.12.4 mL/100 mL per minute ) was higher than PS in contralateral regions ( 3.61.7 mL/100 mL per minute ; P < 0.001 ) .


Relative edema growth ( 0-24 hours ) was not predicted by perihematoma PS ( = -0.192 [ -0.06 to 0.01 ] ) or SBP change ( = -0.092 [ -0.002 to 0.001 ] ) .


SBP was lower in the < 150 target group ( 139.222.1 mm Hg ) than in the < 180 group ( 159.712.3 mm Hg ; P < 0.0001 ) .


Perihematoma PS was not different between groups ( 4.92.4 mL/100 mL per minute for the < 150 group , 5.32.4 mL/100 mL per minute for the < 180 group ; P = 0.51 ) .


BBB permeability is focally increased in the hematoma and perihematoma regions of acute intracerebral hemorrhage patients .


BBB compromise does not predict acute perihematoma edema volume or edema growth .


SBP reduction does not affect BBB permeability .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00963976 .


To implement and evaluate an evidence-informed multicomponent strategy to reduce physical restraint use in older adults admitted to acute care medical units .


Stepped-wedge trial .


Four acute care medical units in Calgary , Alberta , over a 4-month time period .


Data were collected from individuals aged 65 and older present on the study units during monthly restraint audits .


Development of opinion leaders among the nursing leadership , education and training of physicians and unit nurses , and implementation of least restraint rounds .


The primary outcome was rate of restraint use as determined from walk-around audits .


Secondary outcomes included number of physician orders for physical restraints on the electronic medical record and fall reports .


Thirteen percent to 27 % of individuals were being restrained on the medical units before the intervention , with the vast majority of restraints being bed rails .


This decreased to 7 % to 14 % after the intervention .


The intervention resulted in a statistically significant reduction in restraint use measured in the early mornings ( P = .01 ) , and this trend continued after adjusting for unit and month ( P = .06 ) .


Similarly , the rate of restraint use trended down at all other measured time periods but was not statistically significant .


A limited number of individuals had an order for physical restraint within their electronic medical record ( 3 % before , 2 % after the intervention ) .


The median number of monthly fall reports did not change ( three before , three after ; P = .60 ) .


A multicomponent team-focused quality improvement intervention has the potential to decrease the use of physical restraints in older hospitalized adults .


To evaluate the effect of neck coordination exercise on sensorimotor function in women with neck pain compared with best-available treatment and sham treatment .


Observer-blinded randomized controlled trial with short-term and 6-month follow-ups .


Women with chronic non-specific neck pain were randomized to 3 groups : neck coordination exercise with a novel training device ; strength training for the neck and shoulders ; or massage .


Each group had 36 participants .


The intervention period was 11 weeks with 22 individually supervised sessions .


Primary outcomes were postural sway measures and precision of goal-directed arm movements .


Secondary outcomes were range of motion for the neck , peak speed of axial rotation , and neck pain .


A repeated measures multivariate analysis of variance ( MANOVA ) was conducted separately on the primary outcomes for the short-term and 6-month evaluations and on the sensorimotor secondary outcomes for the 6-month effect .


The 6-month effect on pain was analysed with a repeated measures analysis of variance ( ANOVA ) .


No significant treatment effects in favour of neck coordination exercise were found for short-term or 6-month evaluations .


Neck coordination exercise is no better than strength training and massage in improving sensorimotor function .


Further research should investigate the use of cut-offs for sensorimotor dysfunctions prior to proprioceptive or coordinative training .


Opioids improve pain from knee and hip osteoarthritis ( OA ) and decrease the functional impairment of patients .


However , there is a possibility that opioids induce analgesia and suppress the physiological pain of OA in patients , thereby inducing the progression of OA changes in these patients .


The purpose of the current study was to investigate the possibility of progressive changes in OA among patients using opioids .


Two hundred knee or hip OA patients were evaluated in the current prospective , randomized , active-controlled study .


Patients were randomized 1:1:1 into three parallel treatment groups : loxoprofen , tramadol/acetaminophen , and transdermal fentanyl groups .


Medication was administered for 12 weeks .


Pain scores and progressive OA changes on X-ray films were evaluated .


Overall , pain relief was obtained by all three groups .


Most patients did not show progressive OA changes ; however , 3 patients in the transdermal fentanyl group showed progressive OA changes during the 12 weeks of treatment .


These 3 patients used significantly higher doses than others in the transdermal fentanyl group .


Additionally , the average pain score for these 3 patients was significantly lower than the average pain score for the other patients in the transdermal fentanyl group .


Fentanyl may induce progressive changes in knee or hip OA during a relatively short period , compared with oral Non-Steroidal Anti-Inflammatory Drugs or tramadol .


Probiotics are live microorganisms that may confer health benefits on the host .


Recent trials of probiotic use among healthy pregnant women demonstrate potential for improved glycemic control .


The aim of this study was to investigate the effects of a probiotic capsule intervention on maternal metabolic parameters and pregnancy outcome among women with gestational diabetes .


This double-blind placebo-controlled randomized trialrecruited pregnant women with a new diagnosis of gestational diabetes or impaired glucose tolerance following a 3-hour 100-g glucose tolerance test .


Women were randomized to a daily probiotic ( Lactobacillus salivarius UCC118 ) or placebo capsule from diagnosis until delivery .


Fasting blood samples were collected at baseline and 4-6 weeks after capsule commencement for analysis of glucose , insulin , c-peptide , and lipids .


The primary outcome was difference in fasting glucose postintervention , first analyzed on an intention-to-treat basis and followed by per-protocol analysis that excluded women commenced on pharmacological therapy ( insulin or metformin ) .


Secondary outcomes were changes in insulin , c-peptide , homeostasis model assessment and lipids , requirement for pharmacological therapy , and neonatal anthropometry .


Of 149 women recruited and randomized , there were nodifferences between the probiotic and placebo groups in postintervention fasting glucose ( 4.65 0.49 vs 4.65 0.53 mmol/L ; P = 373 ) , requirement for pharmacological therapy ( 17 % vs 14 % ; P = .643 ) , or birthweight ( 3.57 0.64 vs 3.60 0.57 kg ; P = .845 ) .


Among 100 women managed with diet and exercise alone , fastingplasma glucose decreased significantly within both the probiotic ( 4.76 0.45 to 4.57 0.42 mmol/L ; P < .001 ) and placebo ( 4.85 0.58 to 4.58 0.45 mmol/L ; P < .001 ) groups , but the levels between groups did not differ ( P = .316 ) .


The late gestation-related rise in totaland low-density lipoprotein ( LDL ) cholesterol was attenuated in theprobiotic vs the placebo group ( +0.27 0.48 vs +0.50 0.52 mmol/L total cholesterol , P = .031 ; +0.08 0.51 vs +0.31 0.45 mmol/L LDL cholesterol , P = .011 ) .


No differences were notedbetween groups in other metabolic parameters or pregnancy outcome .


A probiotic capsule intervention among women with abnormal glucose tolerance had no impact on glycemic control .


The observed attenuation of the normal pregnancy-induced rise in total and LDL cholesterol following probiotic treatment requires further investigation , particularly in this obstetric group at risk of future metabolic syndrome .


Various designs of braces including hinged and nonhinged models are used to provide external support of the ankle .


Hinged ankle braces supposedly allow almost free dorsiflexion and plantar flexion of the foot in the sagittal plane .


It is unclear , however , whether this additional degree of freedom affects the stabilizing effect of the brace in the other planes of motion .


To investigate the dynamic and passive stabilizing effects of 3 ankle braces , 2 hinged models that provide free plantar flexion-dorsiflexion in the sagittal plane and 1 ankle brace without a hinge .


Crossover study .


University Movement Analysis Laboratory .


Seventeen healthy volunteers ( 5 women , 12 men ; age = 25.4 4.8 years ; height = 180.3 6.5 cm ; body mass = 75.5 10.4 kg ) .


We dynamically induced foot inversion on a tilting platform and passively induced foot movements in 6 directions via a custom-built apparatus in 3 brace conditions and a control condition ( no brace ) .


Maximum inversion was determined dynamically using an in-shoe electrogoniometer .


Passively induced maximal joint angles were measured using a torque and angle sensor .


We analyzed differences among the 4 ankle-brace conditions ( 3 braces , 1 control ) for each of the dependent variables with Friedman and post hoc tests ( P < .05 ) .


Each ankle brace restricted dynamic foot-inversion movements on the tilting platform as compared with the control condition , whereas only the 2 hinged ankle braces differed from each other , with greater movement restriction caused by the Ankle X model .


Passive foot inversion was reduced with all ankle braces .


Passive plantar flexion was greater in the hinged models as compared with the nonhinged brace .


All ankle braces showed stabilizing effects against dynamic and passive foot inversion .


Differences between the hinged braces and the nonhinged brace did not appear to be clinically relevant .


Untreated postoperative urinary retention can result in permanent lower urinary tract dysfunction and can be prevented by timely bladder catheterization .


The author hypothesized that the incidence of postoperative bladder catheterization can be decreased by using the patient 's own maximum bladder capacity ( MBC ) instead of a fixed bladder volume of 500 ml as a threshold for catheterization .


Randomized parallel-arm and single-blinded comparative effectiveness trial conducted in 1,840 surgical patients , operated under general or spinal anesthesia without an indwelling urinary catheter .


Patients were randomized to either use their individual MBC ( index ) or a fixed bladder volume of 500 ml ( control ) as a threshold for postoperative bladder catheterization .


Preoperatively , the MBC was determined at home by voiding in a calibrated bowl .


All other bladder volumes were measured by ultrasound .


Postoperatively , bladder catheterization was performed when spontaneous voiding was impossible , and the ultrasound measurement exceeded the threshold for the group in which the patient was randomized ( 500 or MBC ) .


The primary outcome was the incidence of bladder catheterization .


The average MBC in the control group was 582 ml ( 199 ml ) and in the index group 611 ml ( 209 ml ) .


The incidence of catheterization decreased from 11.8 % ( 107 of 909 patients ) in the control group to 8.6 % ( 80 of 931 ) in the index group ( relative risk 0.73 , 95 % CI 0.55 to 0.96 , P = 0.025 ) .


There were no adverse events in either group .


In patients undergoing surgery under general or spinal anesthesia using the MBC rather than a fixed 500 ml threshold for bladder catheterization is a safe approach that significantly reduces the incidence of postoperative bladder catheterizations .


To improve the therapeutic index of whole-brain radiation therapy ( WBRT ) in the treatment of brain metastases ( BM ) from breast cancer , we investigated the efficacy and safety of WBRT combined with temozolomide ( TMZ ) in this population .


This phase II multicenter prospective randomized study included patients with newly diagnosed intraparenchymal BMs from breast cancer , unsuitable for surgery or radiosurgery .


All patients received conformal WBRT ( 3 Gy 10-30 Gy ) , with or without concomitant TMZ administered at a dosage of 75 mg/m ( 2 ) / day during the irradiation period .


The primary end point was objective response rate ( ORR ) 6 weeks after the end of treatment , defined as a partial or complete response on systematic brain MRI ( modified WHO criteria ) .


Secondary end points were progression-free survival ( PFS ) and overall survival ( OS ) , neurologic symptoms , and tolerability .


Between February 2008 and November 2010 , 100 patients were enrolled in the study ( 50 in the WBRT + TMZ arm , 50 in the WBRT arm ) .


Median age was 55 years ( 29-79 ) .


Median follow-up was 9.4 months [ 1.0-68 .1 ] .


ORRs at 6 weeks were 36 % in the WBRT arm and 30 % in the WBRT + TMZ arm ( NS ) .


In the WBRT arm , median PFS was 7.4 months and median OS was 11.1 months .


In the WBRT + TMZ arm , median PFS was 6.9 months and median OS was 9.4 months .


Treatment was well tolerated in this arm : the most common grade 2 acute toxicity was reversible lymphopenia .


WBRT combined with TMZ did not significantly improve local control and survival in patients with BMs from breast cancer .


CLINICALTRIALS.GOV : NCT00875355 .


The aim was to evaluate the agreement between and the reproducibility of transperineal and transvaginal ultrasound cervical length measurements performed by the duty obstetrical team in case of preterm labor .


The acceptability of transperineal ultrasonography was also assessed .


Pregnant patients between 25 and 34weeks of gestation with contractions and a clinically modified cervix were included .


Order of ultrasonography examination ( transperineal or transvaginal first ) and rank of operator ( resident or senior ) were allocated randomly .


Agreement was assessed using the intraclass correlation coefficient ( ICC ) and the Bland and Altman plot .


The patient 's discomfort and preference for either method were assessed with a questionnaire .


62 patients admitted for preterm labor between 25 and 34weeks of gestation were included .


Six seniors and nine residents took part in the study .


Among the 51 patients with an interpretable transperineal ultrasound scan , median cervical length measurements with the transperineal and the transvaginal technique were , respectively , 25mm ( 0-53 ) and 27mm ( 4-51 ) .


Concordance was good with an ICC of 0.83 [ IC 95 % = ( 0.73-0 .90 ) ] .


Transperineal ultrasonography was preferred in 56.5 % of cases .


In case of preterm labor , cervical length measurement with transperineal ultrasonography seems reproducible and can be performed by the obstetric team on duty .


To determine if intervention school students who received skills-based breast self-exam ( BSE ) / testicular self-exam ( TSE ) training were more likely than control school students to report higher intentions to perform BSE/TSE , greater BSE/TSE self-efficacy , and actual performance of BSE/TSE .


BSE/TSE behaviors , intentions , and self-efficacy were assessed in a high school-based trial ( N = 6 schools ; 3 schools randomized/condition ) using self-reported data at 3 time points ( N = 1058 , 9 th grade students ) .


At follow-up , intervention students had greater BSE/TSE intentions and self-efficacy than control students .


Intervention students were more likely than control students to report monthly BSE ( 54.8 % vs 27.2 % , p = .031 ) and TSE ( 81.5 % vs 31.4 % , p = .010 ) .


Skills-based interventions with goal setting affect teenagers ' self-examination behaviors , intentions , and self-efficacy .


Teaching self-screening may empower teenagers to become more engaged in their preventive health , which may lead to improved health as they age .


Knowing how commonly used drugs affect performance monitoring is of great importance , because drug use is often associated with compromised behavioral control .


Two of the most commonly used recreational drugs in the western world , 3,4-methylenedioxymethamphetamine ( MDMA or `` ecstasy '' ) and ethanol ( alcohol ) , are also often used in combination .


The error-related negativity ( ERN ) , correct-related negativity ( CRN ) , and N2 are electrophysiological indices of performance monitoring .


The present study aimed to investigate how ethanol , MDMA , and their co-administration affect performance monitoring as indexed by the electrophysiological correlates .


Behavioral and EEG data were obtained from 14 healthy volunteers during execution of a speeded choice-reaction-time task after administration of ethanol , MDMA , and combined ethanol and MDMA , in a double-blind , placebo-controlled , randomized crossover design .


Ethanol significantly reduced ERN amplitudes , while administration of MDMA did not affect the ERN .


Co-administration of MDMA and ethanol did not further impair nor ameliorate the effect of ethanol alone .


No drug effects on CRN nor N2 were observed .


A decreased ERN following ethanol administration is in line with previous work and offers further support for the impairing effects of alcohol intoxication on performance monitoring .


This impairment may underlie maladaptive behavior in people who are under influence .


Moreover , these data demonstrate for the first time that MDMA does not affect performance monitoring nor does it interact with ethanol in this process .


These findings corroborate the notion that MDMA leaves central executive functions relatively unaffected .


We examined the effect of two interventions on both the reliability and validity of regulatory judgments : adjusting the regulatory instrument and attending a consensus meeting .


We adjusted the regulatory instrument .


With a randomized controlled trial ( RCT ) we examined the effect of the adjustments we made to the instrument .


In the consensus meeting inspectors discussed cases and had to reach consensus about the order of the cases .


We used a before and after case study to assess the effect of the consensus meeting .


We compared the judgments assigned in the RCT with the unadjusted instrument with the judgments assigned with the unadjusted instrument after the consensus meeting .


Moreover we explored the effect of increasing the number of inspectors per regulatory visit based on the estimates of the two interventions .


The consensus meeting improved the agreement between inspectors ; the variance between inspectors was smallest ( 0.03 ) and the reliability coefficient was highest ( 0.59 ) .


Validity is assessed by examining the relation between the assigned judgments and the corporate standard and expressed by a correlation coefficient .


This coefficient was highest after the consensus meeting ( 0.48 ) .


Adjustment of the instrument did not increase reliability and validity coefficients .


Participating in a consensus meeting improved reliability and validity .


Increasing the number of inspectors resulted in both higher reliability and validity values .


Organizing consensus meetings and increasing the number of inspectors per regulatory visit seem to be valuable interventions for improving regulatory judgments .


Falls are a major problem in hospitals and nursing homes .


The consequences of falls can be severe , both for the individual and for the caring institution .


The aim of the work presented here is to reduce the number of falls on a geriatric ward by monitoring patients more closely .


To achieve this goal , a bed-exit alarm that reliably detects an attempt to get up has been constructed .


A requirements analysis revealed the nurses ' and physicians ' needs and preferences .


Based on the gathered information , an incremental design process generated different prototypes .


These were tested for the reliability of their ability to detect attempts to get up in both laboratory settings and with geriatric patients .


Based on the result of these tests , a scalable technical solution has been developed and proven its reliability in a 1-year , randomized controlled pilot clinical trial on a geriatric ward .


The developed system is unobtrusive and easy to deploy .


It has been tested in laboratory settings , usability tests and a 1-year randomized clinical trial with 98 patients .


This paper focuses on the technical development of the system .


We present different prototypes , the experiments and the pilot study used to evaluate their performance .


Last but not least , we discuss the lessons learned so far .


The developed bed-exit alarm is able to reliably detect patients ' attempts to get up .


The results of the clinical trial show that the system is able to reduce the number of falls on a geriatric ward .


Next steps are the design of a specialized sensor node that is easier to use and can be applied on an even larger scale due to its reduced cost .


A multicenter trial with a larger number of patients is required to confirm the results of this pilot study .


To determine the effects of Yishenjiangzhuo granules ( YJG ) on bone metabolism and to explore the changes in levels of bone Gla protein ( BGP ) , tartrate-resistant acid phosphatase ( TRAP ) , as well as their relationships with levels of B cells , regulatory T cells ( Treg ) and interleukin ( IL ) -17 in patients with stage 3-4 chronic kidney disease ( CKD ) before and after treatment .


Fifty-three stage 3-4 CKD patients were divided randomly into two groups : YJG treatment and control .


Peripheral blood was taken from two groups of CKD patients and 21 healthy subjects in the normal group .


The parameters determined were the levels of CD4 + , CD19 + , CD19 + CD69 + , CD19 + av , Treg ( CD4 + CD25 + CD127lo ) , BGP , TRAP , IL-17 , calcium , phosphate , blood urea nitrogen , serum creatinine ( SCr ) , hemoglobin ( Hb ) in peripheral blood , and urinary creatinine .


Calcium-phosphate products and endogenous creatinine clearance rate ( CCr ) were calculated according to standard protocols .


In YJG and control groups , SCr levels were lowered ( P < 0.01 ) after treatment , whereas CCr ( P < 0.05 ) as well as Hb and albumin levels ( P < 0.01 ) were increased .


The changes in levels of CCr and SCr in the YJG group were more significant .


After treatment , CD19 + CD69 + and Treg levels in the two groups varied ( P < 0.01 ) compared with those of the normal group ; the level of CD19 + increased but the levels of CD4 + and CD19 + AV decreased ( P < 0.01 ) in both groups .


Compared with the control group , the changes of CD19 + and CD19 + AV in the YJG group were more apparent ( P < 0.05 ) .


Compared with the normal group , levels of IL-17 in both groups increased significantly ( P < 0.01 ) , and the difference in the control group was more significant ( P < 0.05 ) .


After treatment , the TRAP level increased ( P < 0.05 ) , but the difference in BGP level ( P > 0.05 ) was not significant .


In stage 3-4 CKD patients , B cells and IL-17 participated in the induction of osteoclast activation .


YJG could also elevate the level of B cells and decrease their apoptosis , but showed no significant effects on active B cells , IL-17 or osteoclast activity .


To investigate whether uterus preserving vaginal sacrospinous hysteropexy is non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments in the surgical treatment of uterine prolapse .


Multicentre randomised controlled non-blinded non-inferiority trial .


4 non-university teaching hospitals , the Netherlands .


208 healthy women with uterine prolapse stage 2 or higher requiring surgery and no history of pelvic floor surgery .


Treatment with sacrospinous hysteropexy or vaginal hysterectomy with suspension of the uterosacral ligaments .


The predefined non-inferiority margin was an increase in surgical failure rate of 7 % .


Primary outcome was recurrent prolapse stage 2 or higher of the uterus or vaginal vault ( apical compartment ) evaluated by the pelvic organ prolapse quantification system in combination with bothersome bulge symptoms or repeat surgery for recurrent apical prolapse at 12 months ' follow-up .


Secondary outcomes were overall anatomical recurrences , including recurrent anterior compartment ( bladder ) and/or posterior compartment ( bowel ) prolapse , functional outcome , complications , hospital stay , postoperative recovery , and sexual functioning .


Sacrospinous hysteropexy was non-inferior for anatomical recurrence of the apical compartment with bothersome bulge symptoms or repeat surgery ( n = 0 , 0 % ) compared with vaginal hysterectomy with suspension of the uterosacral ligaments ( n = 4 , 4.0 % , difference -3.9 % , 95 % confidence interval for difference -8.6 % to 0.7 % ) .


At 12 months , overall anatomical recurrences , functional outcome , quality of life , complications , hospital stay , measures on postoperative recovery , and sexual functioning did not differ between the two groups .


Five serious adverse events were reported during hospital stay .


None was considered to be related to the type of surgery .


Uterus preservation by sacrospinous hysteropexy was non-inferior to vaginal hysterectomy with suspension of the uterosacral ligaments for surgical failure of the apical compartment at 12 months ' follow-up .


trialregister.nl NTR1866 .


Lifestyle interventions affect patients ' risk factors for metabolic syndrome ( MeSy ) , a pre-stage to cardiovascular diseases , diabetes and related complications .


An effective lifestyle intervention is the Swedish Bjrkns intervention , a 3-year randomized controlled trial in primary care for MeSy patients .


To include future disease-related cost and health consequences in a cost-effectiveness analysis , a simulation model was used to estimate the short-term ( 3-year ) and long-term ( lifelong ) cost-effectiveness of the Bjrkns study .


A Markov micro-simulation model was used to predict the cost and quality-adjusted life years ( QALYs ) for MeSy-related diseases based on ten risk factors .


Model inputs were levels of individual risk factors at baseline and at the third year .


The model estimated short-term and long-term costs and QALYs for the intervention and control groups .


The cost-effectiveness of the intervention was assessed using differences-in-differences approach to compare the changes between the groups in the health care and societal perspectives , using a 3 % discount rate .


A 95 % confidence interval ( CI ) , based on bootstrapping , and sensitivity analyses describe the uncertainty in the estimates .


In the short-term , costs are predicted to increase over time in both groups , but less in the intervention group , resulting in an average cost saving/reduction of US$ -700 ( in 2012 , US$ 1 = six point five seven SEK ) and US$ -500 , in the societal and health care perspectives .


The long-term estimate also predicts increased costs , but considerably less in the intervention group : US$ -7,300 ( 95 % CI : US$ -19,700 to US$ -1,000 ) in the societal , and US$ -1,500 ( 95 % CI : US$ -5,400 to US$ 2,650 ) in the health care perspective .


As intervention costs were US$ 211 per participant , the intervention would result in cost saving .


Furthermore , in the long-term an estimated 0.46 QALYs ( 95 % CI : 0.12 to 0.69 ) per participant would be gained .


The Swedish Bjrkns study appears to reduce demands on societal and health care resources and increase health-related quality of life .


The number of routine antenatal visits provided to low risk nulliparous women has been reduced in the UK , acknowledging this change in care may result in women being less satisfied with their care and having poorer psychosocial outcomes .


The primary aim of the study was to investigate whether the provision of proactive telephone support intervention ( TSI ) with and without uterine artery Doppler screening ( UADS ) would reduce the total number of antenatal visits required .


A secondary aim was to investigate whether the interventions affected psychological outcomes .


A three-arm randomised controlled trial involving 840 low risk nulliparous women was conducted at a large maternity unit in North East England .


All women received antenatal care in line with current UK guidance .


Women in the TSI group ( T ) received calls from a midwife at 28 , 33 and 36 weeks and women in the telephone and Doppler group ( T + D ) received the TSI and additional UADS at 20 weeks ' gestation .


The main outcome measure was the total number of scheduled and unscheduled antenatal visits received after 20 weeks ' gestation .


The median number of unscheduled ( n = 2.0 ) , scheduled visits ( n = 7.0 ) and mean number of total visits ( n = 8.8 ) were similar in the three groups .


The majority ( 67 % ) of additional antenatal visits were made to a Maternity Assessment Unit because of commonly occurring pregnancy complications .


Additional TSI + / - UADS was not associated with differences in clinical outcomes , levels of anxiety , social support or satisfaction with care .


There were challenges to the successful delivery of the telephone support intervention ; 59 % of women were contacted at 29 and 33 weeks gestation reducing to 52 % of women at 37 weeks .


Provision of additional telephone support ( with or without UADS ) in low risk nulliparous women did not reduce the number of unscheduled antenatal visits or reduce anxiety .


This study provides a useful insight into the reasons why this client group attend for unscheduled visits .


ISRCTN62354584 .


To assess whether adding clopidogrel to acetylsalicylic acid ( ASA ) has a long-term protective vascular effect in patients with lacunar stroke while taking ASA .


Post hoc analysis of 838 patients with ASA failure and recent lacunar stroke from the Secondary Prevention of Small Subcortical Strokes Trial ( SPS3 ) cohort randomly allocated to aspirin ( 325 mg/day ) and clopidogrel ( 75 mg/day ) or placebo .


Primary efficacy outcome was stroke recurrence ( ischemic and intracranial hemorrhage ) and main safety outcome was major extracranial hemorrhage .


Patients were followed for a mean period of 3.5 years .


The ASA failure group had a significantly higher risk of vascular events including ischemic stroke when compared with the non-ASA failure group ( n = 2,151 ) in SPS3 ( p = 0.03 ) .


Mean age was 65.6 years and 65 % were men .


The risk of recurrent stroke was not reduced in the dual antiplatelet group , 3.1 % per year , compared to the aspirin-only group , 3.3 % per year ( hazard ratio [ HR ] 0.91 ; 95 % confidence interval [ CI ] 0.61-1 .37 ) .


There was also no difference between groups for ischemic stroke ( HR 0.90 ; 95 % CI 0.59-1 .38 ) .


The risk of gastrointestinal bleeding was higher in the dual antiplatelet group ( HR 2.7 ; 95 % CI 1.1-6 .9 ) ; however , the risk of intracranial hemorrhage was not different .


In patients with a recent lacunar stroke while taking ASA , the addition of clopidogrel did not result in reduction of vascular events vs continuing ASA only .


This study provides Class I evidence that for patients with recent lacunar stroke while taking ASA , adding clopidogrel as compared to continuing ASA alone does not reduce the risk of recurrent stroke .


To describe the perinatal and infant and early childhood morbidity associated with preterm premature rupture of membranes ( PROM ) in a cohort of twin pregnancies evaluated prospectively with neonatal follow-up to 2 years of age .


This was a secondary analysis of a randomized controlled trial of magnesium sulfate for prevention of cerebral palsy .


Inclusion criteria were twin gestation with preterm PROM diagnosed between 24 0/7 and 31 6/7 weeks of gestation and planned expectant management .


Latency ( time from membrane rupture to delivery ) and perinatal outcomes were evaluated by gestational age at membrane rupture .


Long-term neonatal outcomes were also analyzed .


Among 151 women who met inclusion criteria , the median gestational age at preterm PROM was 28.1 weeks ( range 24.1-31 .6 weeks ) .


Approximately one-third of women achieved a latency of at least 1 week .


Gestational age at preterm PROM ( odds ratio [ OR ] 0.75 , 95 % confidence interval [ CI ] 0.63-0 .90 for each week after 24 weeks of gestation ) and cervical dilation at admission ( OR 0.66 , 95 % CI 0.49-0 .90 for each centimeter of dilation ) were inversely associated with a latency period of at least 1 week .


There were no stillbirths ( 95 % CI 0-1 % ) , but the rate of neonatal mortality was 90 per 1,000 newborns ( 95 % CI 57-112 ) with a 7.3 % cerebral palsy rate among survivors ( 95 % CI 4.4-10 .3 % ) .


In twin pregnancies , preterm PROM from 24 to 31 weeks of gestation is associated with a neonatal mortality rate of 9.0 % and an overall cerebral palsy rate of 7.3 % .


A longer latency period is associated with less advanced cervical dilation and later gestational age at PROM .


LEVEL OF EVIEDENCE : II .


In the EINSTEIN DVT and EINSTEIN PE studies , the majority of patients received heparins to bridge the period during venous thromboembolism ( VTE ) diagnosis confirmation and the start of the study .


In contrast to vitaminK antagonists ( VKAs ) , rivaroxaban may not require initial heparin treatment .


To evaluate the effect of prestudy heparin on the efficacy and safety of rivaroxaban relative to enoxaparin/VKA , the 3-month incidence of recurrent VTE , and the 14-day incidence of major and nonmajor clinically relevant bleeding were compared in patients who did and did not receive prestudy heparin .


Of the 8,281 patients randomized , 6,937 ( 83.8 % ) received prestudy heparin ( mean SD duration = rivaroxaban : 1.04 [ 0.74 ] days ; enoxaparin 1.03 [ 0.42 ] days ) , and 1,344 ( 16.2 % ) did not .


In patients who did not receive prestudy heparin , the incidences of recurrent VTE were similar in rivaroxaban ( 15 of 649 , 2.3 % ) and enoxaparin/VKA ( 13 of 695 , 1.9 % ) patients ( adjusted hazard ratio [ HR ] = 1.11 ; 95 % confidence interval [ CI ] = 0.52 to 2.37 ) .


The incidences of recurrent VTE were also similar in rivaroxaban ( 54 of 3,501 , 1.5 % ) and enoxaparin/VKA ( 69 of 3,436 , 2.0 % ) patients who did receive prestudy heparin ( adjusted HR = 0.74 ; 95 % CI = 0.52 to 1.06 ; pinteraction = 0.32 ) .


The incidences of major or nonmajor clinically relevant bleeding with rivaroxaban were not significantly different from those with enoxaparin/VKA , either with ( 105 of 3,485 , 3.0 % vs. 104 of 3,428 , 3.0 % ; adjusted HR = 0.98 ; 95 % CI = 0.75 to 1.29 ) or without ( 24 of 645 , 3.7 % vs. 30 of 688,4.4 % ; adjusted HR = 0.81 ; 95 % CI = 0.46 to 1.40 ; pinteraction = 0.68 ) prestudy heparin .


Although the majority of patients in the EINSTEIN studies received prestudy heparin , there were no notable differences in treatment effect of rivaroxaban versus enoxaparin/VKA in those who did and did not receive it .


To compare , in an unselected population of nulliparous pregnant women , the postnatal effect of prenatal supervised pelvic floor muscle training with written instructions on postpartum urinary incontinence ( UI ) .


In a randomized controlled trial in two parallel groups , 282 women were recruited from five university teaching hospitals in France and randomized during the second trimester of pregnancy .


The physiotherapy group received prenatal individually supervised exercises .


Both groups received written instructions about how to perform exercises at home .


Women were blindly assessed at baseline , end of pregnancy , and 2 and 12 months postpartum .


The primary outcome measured was UI severity , assessed with an International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form score ( range 0-21 ; 1-5 is slight UI ) at 12 months postpartum ; other outcomes were UI prevalence and pelvic floor troubles assessed using self-administered questionnaires .


To give a 1-point difference in UI severity score , we needed 91 women in each group ( standard deviation 2.4 , = 0.05 , = 0.20 , and bilateral analysis ) .


Between February 2008 and June 2010 , 140 women were randomized in the physiotherapy group and 142 in the control group .


No difference was observed between the two groups in UI severity , prevalence , or pelvic floor troubles at baseline , end of pregnancy , and at 2 and 12 months postpartum .


At 12 months postpartum , the primary outcome was available for 190 women ( 67.4 % ) ; mean UI severity was 1.9 in the physiotherapy group compared with 2.1 in the control group ( P = .38 ) .


Prenatal supervised pelvic floor training was not superior to written instructions in reducing postnatal UI .


ClinicalTrials.gov ; www.clinicaltrials.gov , NCT00551551 .


I.


Human epidermal growth factor receptor 2 ( HER2 ) amplification is present in a subgroup of gastroo-esophageal cancers ( GCs ) .


HER2 inhibition with trastuzumab has shown to improve outcomes in advanced disease .


Lapatinib ditosylate ( LAP ) , a dual anti-epidermal growth factor receptor ( EGFR ) and anti-HER2 tyrosine kinase inhibitor with preclinical activity against GC , has been approved in HER2-positive breast cancer .


We aimed to study the activity of LAP in HER2-amplified GC .


Patients ( pts ) with HER2-positive ( gene amplification or increased copy numbers based on predefined criteria ) advanced GC were randomly allocated 1:1 to receive LAP 1250mg per day 1-21 plus capecitabine ( CAP ) 2000mg/m ( 2 ) on days 1-14 of a 21-day cycle or LAP 1500mg monotherapy day 1-21 after having failed on a platinum-based first-line therapy .


HER2 status was assessed centrally .


The primary end-point was the objective response rate ( ORR ) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors ( RECIST , version 1.1 ) .


We aimed to include 38 pts per arm to show an interesting response rate of 20 % in either of the two arms .


37 pts were enrolled ( 18 to LAP+CAP , 19 to LAP ) .


Pts had received a median of three prior treatment lines .


12 pts in the LAP+CAP group ( 67 % ) and 12 pts in the LAP group ( 63 % ) had received prior trastuzumab .


Only two pts ( 11.1 % ; 95 % confidence interval ( CI ) : 1.37-34 .7 ) , both in the LAP+CAP arm , achieved an objective response .


The study was closed prematurely for futility .


Median time to progression was 42 ( 95 % CI : 38-61 ) days in the LAP group and 83 ( 95 % CI : 42-86 ) days in the LAP+CAP group .


Other secondary efficacy end-points ( progression-free and overall survival ) were comparable in the two treatment groups .


Rates of diarrhoea were higher with LAP+CAP ( 61 % ; 95 % CI : 35-83 ) compared to 26 % ( 95 % CI 9-51 ) with LAP mono , whereas other adverse events were mostly similar between the groups ( 18 [ 100 % ] versus 17 [ 90 % ] ) .


Lapatinib showed insufficient activity in HER2-amplified pretreated advanced GC .


The safety profile of LAP or LAP+CAP was as expected with some more toxicity in the combination arm .


( ClinicalTrials.gov Identifier , NCT01145404 ) .


To determine if infrared laser acupuncture ( LA ) may have a specific effect in reducing pain and disability in treatment of chronic low back pain ( LBP ) .


This was a double-blind sham laser controlled trial performed in general practices in Perth , Western Australia .


The participants were 144 adults with chronic non-specific LBP .


They were randomised to receive eight once-weekly treatments .


Laser machines ( 20 mW , 840 nm diode , power density 0.1 W/cm ( 2 ) ) stimulated points in three treatment groups : sham ( 0 joules/point ) , low dose ( 0.2 J/point ) and high dose ( 0.8 joules/point ) .


Participants were followed-up at 1 and 6 weeks , and 6 and 12 months post treatment .


Primary outcomes were pain ( Numerical Pain Rating Scale ( NPRS ) ) and disability ( Oswestry Disability Inventory ( ODI ) ) at 6 weeks post treatment .


Secondary outcomes included numerical rating scale for limitation of activity , global assessment of improvement , analgesic usage and adverse effects after treatment .


The analysis showed no difference between sham and the laser groups at 6 weeks for pain or disability .


There was a significant reduction in mean pain and disability in all groups at 6 weeks ( p < 0.005 ) ; NPRS : sham ( -1.5 ( 95 % CI -2.1 to -0.8 ) ) , low dose ( -1.3 ( -2.0 to -0.8 ) ) , high dose ( -1.1 ( -1.7 to -0.5 ) ) .


ODI : sham ( -4.0 ( -7.1 to -1.0 ) ) , low dose ( -4.1 , ( -6.7 to -1.5 ) ) , high dose ( -2.6 ( -5.7 to 0.5 ) ) .


All secondary outcomes also showed clinical improvement over time but with no differences between groups .


LA using energy density range ( 0-4 J/cm ( 2 ) ) for the treatment of chronic non-specific LBP resulted in clinical improvement unrelated to laser stimulation .


http://www.anzctr.org.au ACTRN12610000043033 .


Pelvic floor physical therapy ( PFPT ) is often used as a treatment of pelvic floor disorders and may improve function after pelvic reconstructive surgery .


However , the long-term impact of this modality is not understood .


This randomized controlled trial compared PFPT to the standard care in women undergoing vaginal reconstruction .


The intervention group received PFPT biweekly until 12 weeks postoperatively , in conjunction with a physician assessment .


Control subjects underwent a physician assessment alone at all postoperative intervals .


The final follow-up was at 24 weeks .


Physical examinations ( pelvic organ prolapse quantification assessment ) , intravaginal electromyography , voiding diaries , and validated questionnaires were completed by all subjects .


The primary outcome was change in the World Health Organization Quality of Life-BREF .


Forty-nine women completed the study , 24 in the PFPT group and 25 in the control group .


Although electromyography measures showed better muscular function in PFPT subjects after 12 weeks , at 6 months after surgery , this was no longer noted .


However , quality of life parameters improved for the entire sample at 24 weeks , with no difference between groups .


Positive change from 12 to 24 weeks was also documented in scores on the Pelvic Floor Distress Inventory-20 ( P = 0.04 ) and Pelvic Floor Impact Questionnaire-7 ( P = 0.018 ) , corresponding with continued improvement in bladder symptoms .


Finally , Prolapse and Incontinence Sexual Questionnaire-12 and Female Sexual Function Index scores improved between 12 and 24 weeks , suggesting better sexual function overall with time elapsed from surgery .


Quality of life improves in all subjects after vaginal reconstructive surgery , with ongoing benefit between 3 and 6 months .


Nevertheless , standardized PFPT was not associated with differences at 24 weeks in this cohort of women .


Prospective , randomized , controlled single-blind intervention trial .


Shock-absorbing insoles ( SAIs ) , compared with usual insoles , were hypothesized to result in larger increases in pressure pain threshold ( PPT ) after 3 weeks of use .


Shock-absorbing insoles can decrease self-reported pain among young soccer players training on artificial turf .


However , nothing is known about the underlying changes in pain sensitivity assessed by PPT .


Methods Seventy-five players were included from the youth teams of under 15 , under 17 , and under 19 years of age , playing for the Aalborg Boldspilklub ( AaB ) professional sports club .


After a randomization stratified by team and age , players were divided into 2 groups , one that received SAIs and a control group that used their usual insoles .


Assessments were made in both groups after 3 weeks of training on artificial turf ( baseline ) and 3 weeks later ( follow-up ) .


The primary outcome was change in PPTs from baseline to follow-up , with PPTs measured over 13 locations on the plantar surface of the foot , leg , and low back of the nonpreferred kicking leg .


A significantly larger increase was found in PPTs from baseline to follow-up for the SAI group compared with the control group ( mean difference , 62 kPa ; 95 % confidence interval [ CI ] : 40 , 85 kPa ) .


The PPTs increased significantly more among the SAI group compared with the control group ( P < .05 ) for the abductor digiti minimi ( mean difference , 82 kPa ; 95 % CI : 6 , 157 kPa ) , tibialis anterior ( mean difference , 125 kPa ; 95 % CI : 20 , 230 kPa ) , medial gastrocnemius ( mean difference , 83 kPa ; 95 % CI : -6 , 171 kPa ) , and erector spinae ( mean difference , 86 kPa ; 95 % CI : -17 , 188 kPa ) .


The use of SAIs resulted in increased PPTs after 3 weeks of training on artificial turf compared with controls , suggesting a protective role of SAIs in pressure sensitivity and pain perception .


The effectiveness of risk stratification for low back pain ( LBP ) management has not been demonstrated in outpatient physical therapy settings .


The purposes of this study were : ( 1 ) to assess implementation of a stratified care approach for LBP management by evaluating short-term treatment effects and ( 2 ) to determine feasibility of conducting a larger-scale study .


This was a 2-phase , preliminary study .


In phase 1 , clinicians were randomly assigned to receive standard ( n = 6 ) or stratified care ( n = 6 ) training .


Stratified care training included 8 hours of content focusing on psychologically informed practice .


Changes in LBP attitudes and beliefs were assessed using the Pain Attitudes and Beliefs Scale for Physiotherapists ( PABS-PT ) and the Health Care Providers Pain and Impairment Relationship Scale ( HC-PAIRS ) .


In phase 2 , clinicians receiving the stratified care training were instructed to incorporate those strategies in their practice and 4-week patient outcomes were collected using a numerical pain rating scale ( NPRS ) , and the Oswestry Disability Index ( ODI ) .


Study feasibility was assessed to identify potential barriers for completion of a larger-scale study .


In phase 1 , minimal changes were observed for PABS-PT and HC-PAIRS scores for standard care clinicians ( Cohen d = 0.00-0 .28 ) .


Decreased biomedical ( -4.52.5 points , d = 1.08 ) and increased biopsychosocial ( +5.52.0 points , d = 2.86 ) treatment orientations were observed for stratified care clinicians , with these changes sustained 6 months later on the PABS-PT .


In phase 2 , patients receiving stratified care ( n = 67 ) had greater between-group improvements in NPRS ( 0.8 points ; 95 % confidence interval = 0.1 , 1.5 ; d = 0.40 ) and ODI ( 8.9 % points ; 95 % confidence interval = 4.1 , 13.6 ; d = 0.76 ) scores compared with patients receiving standard physical therapy care ( n = 33 ) .


In phase 2 , treatment was not randomly assigned , and therapist adherence to treatment recommendations was not monitored .


This study was not adequately powered to conduct subgroup analyses .


In physical therapy settings , biomedical orientation can be modified , and risk-stratified care for LBP can be effectively implemented .


Findings from this study can be used for planning of larger studies .


The Saphenous Vein Versus Right Internal Thoracic Artery as a Y-Composite Graft ( SAVE RITA ) trial was designed to evaluate the noninferiority of the saphenous vein ( SV ) compared with the right internal thoracic artery ( [ R ] ITA ) used as a Y-composite graft .


A total of 224 patients who had undergone off-pump revascularization for multivessel coronary artery disease using the SV or RITA as a Y-composite graft based on the in situ left ITA were assigned randomly to the SV Y-composite graft ( SV group , n = 112 ) or free RITA Y-composite graft ( RITA group , n = 112 ) .


The primary endpoint was the 1-year angiographic patency rate of the second limb conduits ( SV or RITA ) .


Postoperative 1-year coronary angiograms were performed in 215 patients ( SV group , 108 ; RITA group , 107 ) .


The overall graft patency rate was 97.4 % ( 745 of 765 ) at 1 year ( 97.9 % in the SV group vs 96.9 % in the RITA group , P = .362 ) .


The primary endpoint of the study , the 1-year patency rate of the SV composite grafts , was 97.1 % ( 238 of 245 ) and was noninferior to that of the RITA composite grafts ( 97.1 % [ 198 of 204 ] ) with a 95 % lower confidence limit of -2.6 % ( P < .001 for noninferiority ) .


The graft qualities , evaluated using the FitzGibbon patency grades , were also similar between the 2 groups ( P = .948 ) .


No statistically significant differences were found in the overall survival rates between the 2 groups at 1 and 4 years ( P = .998 ) .


Also , no statistically significant differences were found between the 2 groups in the freedom from major adverse cardiac and cerebrovascular event rates at 1 and 4 years ( P = .597 ) .


The SV composite grafts were noninferior to the RITA composite grafts in terms of the 1-year angiographic patency rates .


The control of bleeding after tooth extraction is a major concern in patients taking warfarin .


Light-emitting diode ( LED ) irradiation with hemostatic gelatin sponge application was investigated .


Patients who took warfarin and required tooth extraction were divided randomly into 3 groups .


The first group was irradiated with blue-violet LED after tooth extraction .


The second group was treated with a hemostatic gelatin sponge and LED irradiation .


The third group was treated with only hemostatic gelatin sponges .


Hemostasis was evaluated at 30 seconds after treatment .


Less than 30 % of the patients achieved hemostasis within 30 seconds in the hemostatic sponge group ; approximately 50 % of the patients in the simple LED irradiation group achieved hemostasis within 30 seconds ; and 86.7 % of the patients in the LED and hemostatic sponge combined group achieved hemostasis within 30 seconds , indicating that combined treatment with LED and hemostatic sponges provided a significantly higher hemostasis than in the hemostatic sponge group ( P < .01 ) .


Blue-violet LED irradiation combined with hemostatic gelatin sponge treatment yielded hemostasis of the extraction socket within 30 seconds without suture in most cases .


It is unknown whether diets with a high dietary total antioxidant capacity ( TAC ) can modify oxidative stress , low-grade inflammation , or liver dysfunction , all of which are risk factors for multiple sclerosis disease .


This study assesses alanine amino-transferase ( ALT ) , aspartate-aminotransferase ( AST ) and gamma-glutamyl transferase ( GGT ) activities in MS patients treated with co-supplemented hemp seed and evening primrose oils as well as Hot-nature diet and the therapeutic potential this intervention .


In this double blind , randomized trial , 100 MS patients with EDSS < 6 were allocated into 3 groups : `` group A '' , who received co-supplemented hemp seed and evening primrose oils with advised Hot-nature diet ; `` group B '' , who received olive oil ; and `` group C '' , who received the co-supplemented oils .


Clinically , EDSS as well as serum level of liver enzymes ( GGT , AST , and ALT ) were assessed at baseline and after 6 months .


Mean follow-up was 1802.9 SD days ( N = 65 , 23 M and 42 F aged 34.258.07 years with disease duration of 6.804.33 years ) .


There was no significant difference in the study parameters at baseline .


Serum levels of liver enzymes ( GGT , AST , and ALT ) were serially monitored .


Intervention was associated with liver function alteration in three groups .


Significance decreased in EDSS score and the levels of liver enzymes were found in groups A and C , whereas elevated serum liver enzymes and EDSS score were observed in group B after the intervention .


Selecting foods according to their Total antioxidant capacity such as co-supplemented hemp seed and evening primrose oils with Hot-nature diet affects antioxidant intake and can have beneficial effects on improving EDSS score and activity of liver enzymes in RRMS patients .


Soy isoflavone supplements are used to treat several chronic diseases , although the data supporting their use are limited .


Some data suggest that supplementation with soy isoflavone may be an effective treatment for patients with poor asthma control .


To determine whether a soy isoflavone supplement improves asthma control in adolescent and adult patients with poorly controlled disease .


Multicenter , randomized , double-blind , placebo-controlled trial conducted between May 2010 and August 2012 at 19 adult and pediatric pulmonary and allergy centers in the American Lung Association Asthma Clinical Research Centers network .


Three hundred eighty-six adults and children aged 12 years or older with symptomatic asthma while taking a controller medicine and low dietary soy intake were randomized , and 345 ( 89 % ) completed spirometry at week 24 .


Participants were randomly assigned to receive soy isoflavone supplement containing 100 mg of total isoflavones ( n = 193 ) or matching placebo ( n = 193 ) in 2 divided doses administered daily for 24 weeks .


The primary outcome measure was change in forced expiratory volume in the first second ( FEV1 ) at 24 weeks .


Secondary outcome measures were symptoms , episodes of poor asthma control , Asthma Control Test score ( range , 5-25 ; higher scores indicate better control ) , and systemic and airway biomarkers of inflammation .


Mean changes in prebronchodilator FEV1 over 24 weeks were 0.03 L ( 95 % CI , -0.01 to 0.08 L ) in the placebo group and 0.01 L ( 95 % CI , -0.07 to 0.07 L ) in the soy isoflavone group , which were not significantly different ( P = .36 ) .


Mean changes in symptom scores on the Asthma Control Test ( placebo , 1.98 [ 95 % CI , 1.42-2 .54 ] vs soy isoflavones , 2.20 [ 95 % CI , 1.53-2 .87 ] ; positive values indicate a reduction in symptoms ) , number of episodes of poor asthma control ( placebo , 3.3 [ 95 % CI , 2.7-4 .1 ] vs soy isoflavones , 3.0 [ 95 % CI , 2.4-3 .7 ] ) , and changes in exhaled nitric oxide ( placebo , -3.48 ppb [ 95 % CI , -5.99 to -0.97 ppb ] vs soy isoflavones , 1.39 ppb [ 95 % CI , -1.73 to 4.51 ppb ] ) did not significantly improve more with the soy isoflavone supplement than with placebo .


Mean plasma genistein level increased from 4.87 ng/mL to 37.67 ng/mL ( P < .001 ) in participants receiving the supplement .


Among adults and children aged 12 years or older with poorly controlled asthma while taking a controller medication , use of a soy isoflavone supplement , compared with placebo , did not result in improved lung function or clinical outcomes .


These findings suggest that this supplement should not be used for patients with poorly controlled asthma .


clinicaltrials.gov Identifier : NCT01052116 .


The increasing investment in malaria rapid diagnostic tests ( RDTs ) to differentiate malarial and non-malarial fevers , and an awareness of the need to improve case management of non-malarial fever , indicates an urgent need for high quality evidence on how best to improve prescribers ' practices .


A three-arm stratified cluster-randomised trial was conducted in 36 primary healthcare facilities from September 2010 to March 2012 within two rural districts in northeast Tanzania where malaria transmission has been declining .


Interventions were guided by formative mixed-methods research and were introduced in phases .


Prescribing staff from all facilities received standard Ministry of Health RDT training .


Prescribers from facilities in the health worker ( HW ) and health worker-patient ( HWP ) arms further participated in small interactive peer-group training sessions with the HWP additionally receiving clinic posters and patient leaflets .


Performance feedback and motivational mobile-phone text messaging ( SMS ) were added to the HW and HWP arms in later phases .


The primary outcome was the proportion of patients with a non-severe , non-malarial illness incorrectly prescribed a ( recommended ) antimalarial .


Secondary outcomes investigated RDT uptake , adherence to results , and antibiotic prescribing .


Standard RDT training reduced pre-trial levels of antimalarial prescribing , which was sustained throughout the trial .


Both interventions significantly lowered incorrect prescribing of recommended antimalarials from 8 % ( 749/8 ,942 ) in the standard training arm to 2 % ( 250/10 ,118 ) in the HW arm ( adjusted RD ( aRD ) 4 % ; 95 % confidence interval ( CI ) 1 % to 6 % ; P = 0.008 ) and 2 % ( 184/10 ,163 ) in the HWP arm ( aRD 4 % ; 95 % CI 1 % to 6 % ; P = 0.005 ) .


Small group training and SMS were incrementally effective .


There was also a significant reduction in the prescribing of antimalarials to RDT-negatives but no effect on RDT-positives receiving an ACT .


Antibiotic prescribing was significantly lower in the HWP arm but had increased in all arms compared with pre-trial levels .


Small group training with SMS was associated with an incremental and sustained improvement in prescriber adherence to RDT results and reducing over-prescribing of antimalarials to close to zero .


These interventions may become increasingly important to cope with the wider range of diagnostic and treatment options for patients with acute febrile illness in Africa .


To observe and evaluate the clinical effect of acupuncture at `` Siguan '' combined with the Gallbladder Meridian acupoints on migraine .


With randomized controlled trial design , 87 patients were randomly divided into an observation group ( 42 cases ) and a control group ( 45 cases ) .


The observation group was treated with acupuncture at `` Siguan '' including Hegu ( LI 4 ) and Taichong ( LR 3 ) , combined with the Gallbladder Meridian acupoints including Fengchi ( GB 20 ) , Shuaigu ( GB 8 ) , Qiuxu ( GB 40 ) and Zulinqi ( GB 41 ) , while the control group was treated with acupuncture at the Gallbladder Meridian acupoints , including Fengchi ( GB 20 ) , Shuaigu ( GB 8 ) , Qiuxu ( GB 40 ) , Zulinqi ( GB 41 ) , Yanglingquan ( GB 34 ) and Hanyan ( GB 4 ) .


The treatment was given every other day in two groups , 3 times per week for totally 6 weeks .


The migraine intensity , migraine frequency and lasting time of each migraine were observed before and after treatment , and 3-month follow-up was performed after treatment .


The clinical efficacy in two groups was evaluated .


Compared with those before treatment , the migraine intensity , frequency and lasting time were all reduced significantly after treatment in the two groups ( all P < 0.01 ) , which were more obvious in the observation group ( all P < 0.05 ) .


At the end of the treatment , the total effective rate was 95.2 % ( 40/42 ) in the observation group and 80.0 % ( 36/45 ) in the control group , which had statistical difference ( P < 0.05 ) .


After 3-month follow-up , the total effective rate was 88.1 % ( 37/42 ) in the observation group and 75.6 % ( 34/45 ) in the control group , which had no statistical difference ( P > 0.05 ) .


The `` Siguan '' combined with the Gallbladder Meridian acupoints could significantly relieve the migraine intensity , frequency and lasting time , and its improvement of symptoms and short-term efficacy are superior to those of the Gallbladder Meridian acupoints alone .


Inflammation , insulin resistance and vascular dysfunction characterize obesity and predict development of cardiovascular disease ( CVD ) .


Although women experience CVD events at an older age , vascular dysfunction is evident 10years prior to coronary artery disease .


Questions remain whether replacing SFA entirely with MUFA or PUFA is the optimal approach for cardiometabolic benefits .


This study tested the hypotheses that : a ) body composition , inflammation and vascular function would improve with a high fat diet ( HFD ) when type of fat is balanced as 1/3 SFA , 1/3 MUFA and 1/3 PUFA ; and b ) body composition , inflammation and vascular function would improve more when balanced HFD is supplemented with 18C fatty acids , in proportion to the degree of 18C unsaturation .


Obese premenopausal women were stabilized on balanced HFD and randomized to consume 9g/d of encapsulated stearate ( 18:0 ) , oleate ( 18:1 ) , linoleate ( 18:2 ) or placebo .


Significant improvements occurred in fat oxidation rate ( 6 % ) , body composition ( % fat : 2.52.1 % ; % lean : 2.52.1 % ) , inflammation ( IL-1 , IL-1 , 1L-12 , Il-17 , IFN , TNF , TNF ) and vascular function ( BP , PAI-1 , tPA activity ) .


When compared to HFD + placebo , HFD + stearate had the greatest effect on reducing IFN ( 74 % ) and HFD + linoleate had the greatest effect on reducing PAI-1 ( 31 % ) .


Balancing the type of dietary fat consumed ( SFA/MUFA/PUFA ) is a feasible strategy to positively affect markers of CVD risk .


Moreover , reductions in inflammatory molecules involved in vascular function might be enhanced when intake of certain 18C fatty acids is supplemented .


Long term effects need to be determined for this approach .


The effects of cholesteryl ester transfer protein ( CETP ) inhibition on lipids , inflammation , and markers of high-density lipoprotein ( HDL ) function , following an acute coronary syndrome ( ACS ) , are unknown .


The dal-ACUTE study randomized 300 patients ( 1 : 1 ) to dalcetrapib 600 mg/day or placebo within 1 week of an ACS .


The primary endpoint was per cent change in HDL-cholesterol ( HDL-C ) after 4 weeks .


Secondary endpoints included apolipoprotein levels , markers of HDL function , and inflammation .


Dalcetrapib treatment increased HDL-C and apolipoprotein A1 by 33.7 and 11.8 % , respectively ( both P < 0.001 ) and total cholesterol efflux by 9.5 % ( P = 0.003 ) after 4 weeks , principally via an increase in non-ATP-binding cassette transporter ( ABC ) A1-mediated efflux , without statistically significant changes in pre-1-HDL levels .


The increase in total efflux with dalcetrapib correlated most strongly with increases in apolipoprotein A1 and HDL-C ( r = 0.46 and 0.43 , respectively ) rather than the increase in pre-1-HDL ( r = 0.32 ) .


Baseline and on-treatment ABCA1-mediated efflux correlated most strongly with pre-1-HDL levels ; in contrast , non-ABCA1-mediated efflux correlated better with apolipoprotein A1 and HDL-C levels .


High-density lipoprotein raised through CETP inhibition with dalcetrapib improves cholesterol efflux , principally via a non-ABCA1-mediated pathway .


While HDL-C was increased by one-third , apolipoprotein A1 and total efflux were increased only by one-tenth , supporting the concept of dissociation between improvements in HDL function and HDL-C levels , which may be of relevance to ongoing trials and the development of therapeutic interventions targeting HDL .


This study was designed to compare the effects of metformin and repaglinide on the fasting plasma glucose ( FPG ) and glycated haemoglobin ( HbA1c ) in newly diagnosed type 2 diabetes in China .


A total of 107 newly diagnosed type 2 diabetic patients ( 46 women and 61 men ) participated in the study .


All patients received 3-month treatment of metformin or repaglinide .


Fasting blood glucose and HbA1c were determined at baseline and at the end of the 3-month of treatment .


FPG and HbA1c decreased in both metformin and repaglinide groups after 3 months treatment ( P < 0.01 ) .


The reduction of HbA1c was significantly greater in the repaglinide group ( P < 0.01 ) .


Metformin decreases fasting insulin concentration and HOMA-IR ( P < 0.01 ) , and repaglinide improves HOMA - ( P < 0.01 ) .


Triglycerides ( TG ) were reduced in both groups ( P < 0.01 in metformin group ; P < 0.05 in repaglinide group ) , but total cholesterol ( TC ) and low-density lipoprotein ( LDL ) were decreased only after metformin treatment ( P < 0.05 ) .


Both repaglinide and metformin were effective in glycaemic control in new onset patients with type 2 diabetes in China .


Repaglinide had no effect on insulin sensitivity , but it improved - cell function .


The potential effect of onartuzumab , when administered with or without bevacizumab in combination with weekly paclitaxel , on the corrected QT interval ( QTc ) and other electrocardiogram ( ECG ) parameters , was investigated in a randomized , phase 2 study OAM4861g of first - or second-line therapy in patients with locally recurrent or metastatic triple-negative breast cancer .


Triplicate 12-lead ECGs were recorded at screening , pre - and post-dose on day 1 of cycles 1 , 2 , and 4 , and at the study drug discontinuation visit ( SDDV ) .


Onartuzumab serum samples were collected pre - and post-dose on day 1 of cycles 1-4 and at the SDDV .


Fridericia 's correction was applied to QT recordings ( QTcF ) , and change from baseline ( QTcF ) was calculated .


Post-baseline measurements were reported as baseline-adjusted control arm ( placebo plus bevacizumab plus paclitaxel ) - corrected values ( QTcF ) .


Categorical ECG findings were noted .


Linear mixed effects modeling evaluated a potential concentration-QTcF relationship .


Out of 185 enrolled patients , 165 patients had ECG-evaluable data for analyses .


Similar QTcF and QTcF values were observed across all treatment arms , with mean increase < 10 and < 7 ms , respectively , across all time points .


Similar changes in heart rate , PR interval , and QRS duration were noted across all treatment arms .


Incidences of abnormal ECG findings of clinical interest were comparable in the onartuzumab-containing arms and the control arm .


No concentration-QTcF relationship was evident at onartuzumab serum concentrations up to 1,200 g/ml .


These data suggest that onartuzumab , at the dose and exposures studied in this clinical trial , does not meaningfully affect the QTcF interval .


Patients with acute ischemic stroke benefit from rapid evaluation and treatment , and timely brain imaging is a necessary component .


We determined the effect of a targeted behavioral intervention on door-to-imaging time ( DIT ) among patients with ischemic stroke treated with tissue-type plasminogen activator .


Second , we examined the variation in DIT accounted for by patient-level and hospital-level factors .


The Increasing Stroke Treatment through Interventional behavioral Change Tactics ( INSTINCT ) trial was a cluster-randomized , controlled trial involving 24 Michigan hospitals .


The intervention aimed to increase tissue-type plasminogen activator utilization .


Detailed chart abstractions collected data for 557 patients with ischemic stroke .


We used a series of hierarchical linear mixed-effects models to evaluate the effect of the intervention on DIT ( difference-in-differences analysis ) and used patient-level and hospital-level explanatory variables to decompose variation in DIT .


DIT improved over time , without a difference between intervention and control hospitals ( intervention : 23.7-19 .3 minutes , control : 28.9-19 .2 minutes ; P = 0.56 ) .


Adjusted DIT was faster in patients who arrived by ambulance ( 7.2 minutes ; 95 % confidence interval , 4.1-10 .2 ) , had severe strokes ( 1.0 minute per +5 - point National Institutes of Health Stroke Scale ; 95 % confidence interval , 0.1-2 .0 ) , and presented in the postintervention period ( 4.9 minutes ; 95 % confidence interval , 2.3-7 .4 ) .


After accounting for these factors , 13.8 % of variation in DIT was attributable to hospital .


Neither hospital stroke volume nor stroke center status was associated with DIT .


Performance on DIT improved similarly in intervention and control hospitals , suggesting that nonintervention factors explain the improvement .


Hospital-level factors explain a modest proportion of variation in DIT , but further research is needed to identify the hospital-level factors responsible .


Establishing or providing occlusion that successfully permits efficient masticatory function is basic to dentistry .


To maintain harmony of the occlusal condition , the posterior teeth must pass close to but not contact their opposing teeth during mandibular movement .


Anterior guidance is essential to a harmonious functional relationship in the masticatory system .


The objective of this study was to find out the frequency of pattern of occlusal contacts in lateral position and to compare the accuracy of shim-stock and articulating paper .


This study was conducted in the Department of Prosthodontics , Kathmandu University School of Medical Sciences .


The study consisted of 80 healthy subjects between the age group of 18-30 years .


They were selected randomly from undergraduate students and dental hygienist of college of dental science and written consent was taken .


This age was selected because of minimal occlusal wear .


In the present study with 80 participants the majority of the contact patterns with shimstock on the working side were group function ( 84 % ) , the canine protected occlusal patterns were found to be 12 % and the unclassifiable pattern were found to be 4 % .


On the otherhand , the data with articulating paper were group function type ( 94 % ) , the canine protected occlusal patterns as 2.5 % and the unclassifiable pattern were found to be 3.5 % .


In this study , with shim stock , the majority of the contact patterns were group function being 84 % whereas with the articulating paper it was 94 % .


When shim stock occlusal strip ( 12 m thick ) was compared to commonly used articulating paper ( 40 m ) , the excessive thickness of articulating paper that exceed the maximum recommended thickness of occlusal recording strips markedly must have given much more false contacts .


It was concluded that the majority of the contact pattern were group function being 84 % with shim stock and 94 % with articulating paper .


Also shim stock exhibits superior accuracy and reliability .


Several pilot studies have evoked interest in robot-assisted therapy ( RAT ) in children with cerebral palsy ( CP ) .


To assess the effectiveness of RAT in children with CP through a single-blind randomized controlled trial .


Sixteen children with CP were randomized into 2 groups .


Eight children performed 5 conventional therapy sessions per week over 8 weeks ( control group ) .


Eight children completed 3 conventional therapy sessions and 2 robot-assisted sessions per week over 8 weeks ( robotic group ) .


For both groups , each therapy session lasted 45 minutes .


Throughout each RAT session , the patient attempted to reach several targets consecutively with the REAPlan .


The REAPlan is a distal effector robot that allows for displacements of the upper limb in the horizontal plane .


A blinded assessment was performed before and after the intervention with respect to the International Classification of Functioning framework : body structure and function ( upper limb kinematics , Box and Block test , Quality of Upper Extremity Skills Test , strength , and spasticity ) , activities ( Abilhand-Kids , Pediatric Evaluation of Disability Inventory ) , and participation ( Life Habits ) .


During each RAT session , patients performed 744 movements on average with the REAPlan .


Among the variables assessed , the smoothness of movement ( P < .01 ) and manual dexterity assessed by the Box and Block test ( P = .04 ) improved significantly more in the robotic group than in the control group .


This single-blind randomized controlled trial provides the first evidence that RAT is effective in children with CP .


Future studies should investigate the long-term effects of this therapy .


Youth mental health is a significant public health concern due to the high prevalence of mental health problems in this population and the low rate of those affected seeking help .


While it is increasingly recognized that prevention is better than cure , most youth prevention programs have utilized interventions based on clinical treatments ( eg , cognitive behavioral therapy ) with inconsistent results .


This study explores the feasibility of the online delivery of a youth positive psychology program , Bite Back , to improve the well-being and mental health outcomes of Australian youth .


Further aims were to examine rates of adherence and attrition , and to investigate the program 's acceptability .


Participants ( N = 235 ) aged 12-18 years were randomly assigned to either of two conditions : Bite Back ( n = 120 ) or control websites ( n = 115 ) .


The Bite Back website comprised interactive exercises and information across a variety of positive psychology domains ; the control condition was assigned to neutral entertainment-based websites that contained no psychology information .


Participants in both groups were instructed to use their allocated website for 6 consecutive weeks .


Participants were assessed pre - and postintervention on the Depression Anxiety Stress Scale-Short form ( DASS-21 ) and the Short Warwick-Edinburgh Mental Well-Being Scale ( SWEMWBS ) .


Of the 235 randomized participants , 154 ( 65.5 % ) completed baseline and post measures after 6 weeks .


Completers and dropouts were equivalent in demographics , the SWEMWBS , and the depression and anxiety subscales of the DASS-21 , but dropouts reported significantly higher levels of stress than completers .


There were no differences between the Bite Back and control conditions at baseline on demographic variables , DASS-21 , or SWEMWBS scores .