We , thus , investigated the effects on the occurrence of headaches of three levels of dietary sodium intake and two diet patterns ( the Dietary Approaches to Stop Hypertension ( DASH ) diet ( rich in fruits , vegetables and low-fat dairy products with reduced saturated and total fat ) and a control diet ( typical of Western consumption patterns ) ) .


Randomised multicentre clinical trial .


Post hoc analyses of the DASH-Sodium trial in the USA .


In a multicentre feeding study with three @day periods , @ participants were randomised to the DASH or control diet .


On their assigned diet , participants ate food with high sodium during one period , intermediate sodium during another period and low sodium during another period , in random order .


Occurrence and severity of headache were ascertained from self-administered questionnaires , completed at the end of each feeding period .


The occurrence of headaches was similar in DASH versus control , at high ( OR ( @ % CI ) = @ ( @ to @ ) ; p = @ ) , intermediate ( @ ( @ to @ ) ; p = @ ) and low ( @ ( @ to @ ) ; p = @ ) sodium levels .


By contrast , there was a lower risk of headache on the low , compared with high , sodium level , both on the control ( @ ( @ to @ ) ; p = @ ) and DASH ( @ ( @ to @ ) ; p = @ ) diets .


A reduced sodium intake was associated with a significantly lower risk of headache , while dietary patterns had no effect on the risk of headaches in adults .


Reduced dietary sodium intake offers a novel approach to prevent headaches .


The altered visual function induced by changes in corneal curvature following filtration surgery is distressing to patients .


The aim of this study was to evaluate surgically induced astigmatism following trabeculectomy in comparison with deep sclerectomy .


In a prospective interventional comparative study , patients with primary open-angle glaucoma were randomly allocated to either group A or B ; deep sclerectomy with mitomycin C @ mg/mL and trabeculectomy with mitomycin C @ mg/mL , respectively .


Keratometry was performed using Topcon KR-@P autokerato-refractometer preoperatively and at @ months postoperatively .


Vector analysis was used to analyze the surgically induced astigmatism .


Sixty eyes of @ patients in group A , and @ eyes of @ patients in group B were enrolled for vector analysis .


The mean preoperative astigmatic vector power was -@ D and +@ D in groups A and B , respectively .


The mean postoperative astigmatic vector power was -@ D in group A and -@ D in group B.


The mean change in astigmatic vector powers was -@ D in group A and -@ D in group B.


When compared with preoperative data in either group , the differences were significant , P = @ & @ in groups A and B respectively , whereas the postoperative difference between either group was insignificant ( P = @ ) .


A total of @ % of corneas got flatter in group B compared with @ % in group A , P = @ .


Both trabeculectomy and deep sclerectomy induced considerable postoperative astigmatism .


A longer follow-up period is recommended to study the different patterns of astigmatism in either procedure .


Based on promising efficacy in a single-arm study , a randomized phase II trial was designed to compare the efficacy and safety of adding rh-endostatin ( Endostar ) to first-line standard etoposide and carboplatin ( EC ) chemotherapy for treatment of extensive-stage small-cell lung cancer .


One hundred forty Chinese patients with pathologically confirmed , extensive-stage small-cell lung cancer were randomly assigned to EC alone or rh-endostatin + EC for @-@ cycles , followed by single-agent rh-endostatin until progression or unacceptable toxicity .


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


The secondary endpoints included overall survival , Objective response rate ( ORR ) , and quality of life .


Median PFS was @ months with rh-endostatin + EC ( n = @ ) and @ months with EC ( n = @ ) ( hazard ratio @ -LSB- @ % confidence interval @-@ @ -RSB- ) .


PFS was significantly higher with rh-endostatin + EC than with EC ( hazard ratio @ -LSB- @-@ @ ; p = @ -RSB- ) in female .


Median overall survival was similar in both groups ( @ versus @ months , respectively -LSB- p = @ -RSB- ) .


ORR was higher in the rh-endostatin + EC group ( @ % ) than in the EC group ( @ % ) ( p = @ ) .


The efficacy of rh-endostatin + EC relative to that of EC was reflected by greater improvements in patient-assessed quality of life scores after @ and @ weeks of treatment .


There was no difference between each regimen in the incidence of nonhematological or Grade III-IV hematological toxicities .


Addition of rh-endostatin to EC for the treatment of extensive-stage small-cell lung cancer had an acceptable toxicity profile , but did not improve overall survival , PFS , and ORR .


Optical trapping is a laser-based method for probing the physiological and mechanical properties of cells in a noninvasive manner .


As sperm motility is an important criterion for assessing the male fertility potential , this technique is used to study sperm cell motility behavior and rotational dynamics .


An integrated optical system with near-infrared laser beam has been used to analyze rotational dynamics of live sperm cells from oligozoospermic and asthenozoospermic cases and compared with controls .


The linear , translational motion of the sperm is converted into rotational motion on being optically trapped , without causing any adverse effect on spermatozoa .


The rotational speed of sperm cells from infertile men is observed to be significantly less as compared to controls .


Distinguishing normal and abnormal sperm cells on the basis of beat frequency above @ Hz may be an important step in modern reproductive biology to sort and select good quality spermatozoa .


The application of laser-assisted technique in biology has the potential to be a valuable tool for assessment of sperm fertilization capacity for improving assisted reproductive technology .


Recent studies have demonstrated safety , feasibility , and decreased hospital length of stay for patients with weakness acquired in the intensive care unit ( ICU ) who receive early physical rehabilitation .


The scored Physical Function in Intensive Care Test ( PFIT-s ) was specifically designed for this population and demonstrated excellent psychometrics in an Australian ICU population .


The purpose of this study was to determine the responsiveness and predictive capabilities of the PFIT-s in patients in the United States admitted to the ICU who required mechanical ventilation ( MV ) for @ days or longer .


This nested study within a randomized trial administered the PFIT-s , Medical Research Council ( MRC ) sum score , and grip strength test at ICU recruitment and then weekly until hospital discharge , including at ICU discharge .


Spearman rho was used to determine validity .


The effect size index was used to calculate measurement responsiveness for the PFIT-s .


The receiver operating characteristic curve was used in predicting participants ' ability to perform functional components of the PFIT-s .


From August @ to July @ , @ patients were recruited from @ ICUs in the Denver , Colorado , metro area .


At ICU discharge , PFIT-s scores were highly correlated to MRC sum scores ( rho = @ ) and grip strength ( rho = @ ) ( P < @ ) .


Using baseline test with ICU discharge ( @ pairs ) , test responsiveness was large ( @ ) .


At ICU discharge , an MRC sum score cut-point of @ predicted participants ' ability to perform the standing components of the PFIT-s .


The small sample size was a limitation .


However , the findings are consistent with those in a larger sample from Australia .


The PFIT-s is a feasible and valid measure of function for individuals who require MV for @ days or longer and who are alert , able to follow commands , and have sufficient strength to participate .


Post-operative nausea and vomiting ( PONV ) ; early or late , has detrimental effects on surgical patients such as surgical wound disruption , esophageal tear and delayed discharge from the post anesthetic care unit .


This study evaluated the effects of dexamethasone-metoclopramide ( DM ) in the prevention of early and late PONV in women undergoing myomectomy under subarachnoid block .


Following approval from the Research and Ethics Committee of the Hospital , informed consent was obtained from each prospective patient .


Patients were randomly allocated to either the DM group , metoclopramide only ( MO ) group or dexamethasones only ( DO ) group using the computer-generated random numbers in sealed envelopes .


Immediately after the induction of spinal anesthesia , the DM group received intravenous ( i.v. ) dexamethasone @ mg and metoclopramide @ mg , the MO group received metoclopramide @ mg i.v and the DO group received dexamethasone @ mg i.v.


The incidence of early and late PONV formed the primary outcome .


A total of @ patients , with aged range between @-@ years were studied .


Dexamethasone alone group had the highest incidence of @ % for early but no for late PONV ( P = @ ) Metoclopramide alone group had an incidence of @ % for early PONV and @ % for late PONV .


There was reduced incidence of both early and late PONV in the DM group , but of lesser magnitude than DO or MO respectively .


Dexamethasone protects against the incidence of late PONV with a minimal effect on early PONV .


The combination of dexamethasone and metoclopramide had comparable effect on both and of better magnitude than metoclopramide alone .


The effects of family therapy for adolescent substance use on parent substance use have not been explored .


To determine the effects of Brief Strategic Family Therapy ( BSFT ) on parent substance use , and the relationship between parent substance use and adolescent substance use .


@ adolescents and parents were randomized to BSFT or Treatment as Usual ( TAU ) across eight outpatient treatment programs .


Parent substance use was assessed at baseline and at @months post-randomization .


Adolescent substance use was assessed at baseline and monthly for @months post-randomization .


Family functioning was assessed at baseline , @ , @ , and @months post-randomization .


Parents in BSFT significantly decreased their alcohol use as measured by the ASI composite score from baseline to @months ( ( @ ) ( @ ) = @ , p = @ ) .


Change in family functioning mediated the relationship between Treatment Condition and change in parent alcohol use .


Children of parents who reported drug use at baseline had three times as many days of reported substance use at baseline compared with children of parents who did not use or only used alcohol ( ( @ ) ( @ ) = @ , p = @ ) .


Adolescents in BSFT had a significantly lower trajectory of substance use than those in TAU ( = -@ , p < @ ) if their parents used drugs at baseline .


BSFT is effective in reducing alcohol use in parents , and in reducing adolescents ' substance use in families where parents were using drugs at baseline .


BSFT may also decrease alcohol use among parents by improving family functioning .


To identify the clinical and laboratory predictors of clinical improvement in a cohort of myositis patients treated with rituximab .


We analyzed data for @ patients with myositis ( @ with adult polymyositis -LSB- PM -RSB- , @ with adult dermatomyositis -LSB- DM -RSB- , and @ with juvenile DM ) in the Rituximab in Myositis trial .


Clinical improvement was defined as @ % improvement in at least @ of the following @ core set measures of disease activity : physician 's and patient 's / parent 's global assessment of disease activity , manual muscle testing , physical function , muscle enzymes , and extramuscular disease activity .


We analyzed the association of the following baseline variables with improvement : myositis clinical subgroup , demographics , myositis damage , clinical and laboratory parameters , core set measures , rituximab treatment , and myositis autoantibodies ( antisynthetase , anti-Mi-@ , anti-signal recognition particle , anti-transcription intermediary factor @ -LSB- TIF-@ -RSB- , anti-MJ , other autoantibodies , and no autoantibodies ) .


All measures were univariately assessed for association with improvement using time-to-event analyses .


A multivariable time-dependent proportional hazards model was used to evaluate the association of individual predictive factors with improvement .


In the final multivariable model , the presence of an antisynthetase , primarily anti-Jo-@ ( hazard ratio -LSB- HR -RSB- @ , P < @ ) , anti-Mi-@ ( HR @ , P < @ ) , or other autoantibody ( HR @ , P = @ ) predicted a shorter time to improvement compared to the absence of autoantibodies .


A lower physician 's global assessment of damage ( HR @ , P = @ ) and juvenile DM ( versus adult myositis ) ( HR @ , P = @ ) also predicted improvement .


Unlike autoantibody status , the predictive effect of physician 's global assessment of damage and juvenile DM diminished by week @ .


Rituximab treatment did not affect these associations .


Our findings indicate that the presence of antisynthetase and anti-Mi-@ autoantibodies , juvenile DM subset , and lower disease damage strongly predict clinical improvement in patients with refractory myositis .


In phase @ studies , evolocumab , a fully human monoclonal antibody to PCSK@ , reduced LDL-C levels in patients receiving statin therapy .


To evaluate the efficacy and tolerability of evolocumab when used in combination with a moderate - vs high-intensity statin .


Phase @ , @-week , randomized , double-blind , placebo - and ezetimibe-controlled study conducted between January and December of @ in patients with primary hypercholesterolemia and mixed dyslipidemia at @ sites in @ countries .


Patients ( n = @ ) were randomized to @ of @ treatment groups in @ steps .


Patients were initially randomized to a daily , moderate-intensity ( atorvastatin -LSB- @ mg -RSB- , simvastatin -LSB- @ mg -RSB- , or rosuvastatin -LSB- @ mg -RSB- ) or high-intensity ( atorvastatin -LSB- @ mg -RSB- , rosuvastatin -LSB- @ mg -RSB- ) statin .


After a @-week lipid-stabilization period , patients ( n = @ ) were randomized to compare evolocumab ( @ mg every @ weeks or @ mg monthly ) with placebo ( every @ weeks or monthly ) or ezetimibe ( @ mg or placebo daily ; atorvastatin patients only ) when added to statin therapies .


Percent change from baseline in low-density lipoprotein cholesterol ( LDL-C ) level at the mean of weeks @ and @ and at week @ .


Evolocumab reduced LDL-C levels by @ % ( @ % CI , @ % to @ % ) to @ % ( @ % CI , @ % to @ % ) ( every @ weeks ) and by @ % ( @ % CI , @ % to @ % ) to @ % ( @ % CI , @ % to @ % ) ( monthly ) vs placebo at the mean of weeks @ and @ in the moderate - and high-intensity statin-treated groups ; the LDL-C reductions at week @ were comparable .


For moderate-intensity statin groups , evolocumab every @ weeks reduced LDL-C from a baseline mean of @ to @ mg/dL to an on-treatment mean of @ to @ mg/dL ; monthly evolocumab reduced LDL-C from a baseline mean of @ to @ mg/dL to an on-treatment mean of @ to @ mg/dL .


For high-intensity statin groups , evolocumab every @ weeks reduced LDL-C from a baseline mean of @ to @ mg/dL to an on-treatment mean of @ to @ mg/dL ; monthly evolocumab reduced LDL-C from a baseline mean of @ to @ mg/dL to an on-treatment mean of @ to @ mg/dL .


Adverse events were reported in @ % , @ % , and @ % of evolocumab - , ezetimibe - , and placebo-treated patients , respectively .


The most common adverse events in evolocumab-treated patients were back pain , arthralgia , headache , muscle spasms , and pain in extremity ( all < @ % ) .


In this @-week trial conducted among patients with primary hypercholesterolemia and mixed dyslipidemia , evolocumab added to moderate - or high-intensity statin therapy resulted in additional LDL-C lowering .


Further studies are needed to evaluate the longer-term clinical outcomes and safety of this approach for LDL-C lowering .


IL-@ is associated with plaque psoriasis susceptibility and pathogenesis .


BI @ is a fully human IgG@ mAb specific for the IL-@ p@ subunit .


This first-in-human proof-of-concept study evaluated the clinical and biological effects of BI @ in patients with moderate-to-severe plaque psoriasis .


We performed a single-rising-dose , multicenter , randomized , double-blind , placebo-controlled , within-dose cohort phase I trial .


Patients received @ , @ , @ , @ , @ , or @ mg/kg BI @ intravenously , @ or @ mg/kg BI @ subcutaneously , or matched placebo .


The primary objective was safety evaluation .


Thirty-nine patients received single-dose BI @ intravenously ( n = @ ) or subcutaneously ( n = @ ) or placebo ( n = @ ) .


Adverse events were reported with similar frequency in the BI @ and placebo groups .


Four serious adverse events ( not considered treatment related ) were reported among BI @-treated patients .


BI @ was associated with clinical improvement from week @ and maintained for up to @ weeks after treatment .


At week @ , @ % , @ % , and @ % decreases in the Psoriasis Area and Severity Index were achieved by @ % , @ % , and @ % of BI @-treated patients ( any dose ) , respectively , versus none receiving placebo .


BI @ treatment resulted in reduced expression of lesional skin genes associated with IL-@ / IL-@ signaling pathways and normalization of psoriatic lesion gene expression profiles to a profile approaching that of nonlesional skin .


Significant correlation between treatment-associated molecular changes and psoriasis area and severity index improvement was observed ( r = @ , P = @ @ ( -@ ) ) .


BI @ was well tolerated and associated with rapid , substantial , and durable clinical improvement in patients with moderate-to-severe psoriasis , supporting a central role for IL-@ in psoriasis pathogenesis .


Accumulated evidence implicates sympathetic activation as inducing oxidative stress and systemic inflammation , which in turn lead to hypertension , endothelial dysfunction , and atherosclerosis in obstructive sleep apnea ( OSA ) .


Statins through their pleiotropic properties may modify inflammation , lipid profile , and cardiovascular outcomes in OSA .


This multicenter , randomized , double-blind study compared the effects of atorvastatin @mg/day versus placebo over @ weeks on endothelial function ( the primary endpoint ) measured by peripheral arterial tone ( PAT ) .


Secondary endpoints included office blood pressure ( BP ) , early carotid atherosclerosis , arterial stiffness measured by pulse wave velocity ( PWV ) , and metabolic parameters .


@ severe OSA patients were randomized .


Key demographics for the study population were age @ @ years , @ % female , and BMI @ @ kg/m ( @ ) .


In intention to treat analysis , mean PAT difference between atorvastatin and placebo groups was @ ( -@ ; @ ) , P = @ .


Total and LDL cholesterol significantly improved with atorvastatin .


Systolic BP significantly decreased with atorvastatin ( mean difference : -@ mmHg ( -@ ; -@ ) , P = @ ) whereas carotid atherosclerosis and PWV were unchanged compared to the placebo group .


In OSA patients , @ months of atorvastatin neither improved endothelial function nor reduced early signs of atherosclerosis although it lowered blood pressure and improved lipid profile .


This trial is registered with NCT@ .


To determine whether a structured mentoring curriculum improves research mentoring skills .


The authors conducted a randomized controlled trial ( RCT ) at @ academic health centers ( June @ to July @ ) .


Faculty mentors of trainees who were conducting clinical/translational research @ % of the time were eligible .


The intervention was an eight-hour , case-based curriculum focused on six mentoring competencies .


The primary outcome was the change in mentors ' self-reported pretest to posttest composite scores on the Mentoring Competency Assessment ( MCA ) .


Secondary outcomes included changes in the following : mentors ' awareness as measured by their self-reported retrospective change in MCA scores , mentees ' ratings of their mentors ' competency as measured by MCA scores , and mentoring behaviors as reported by mentors and their mentees .


A total of @ mentor-mentee pairs were enrolled : @ mentors were randomized to the intervention ; @ to the control condition .


Self-reported pre - / posttest change in MCA composite scores was higher for mentors in the intervention group compared with controls ( P < @ ) .


Retrospective changes in MCA composite scores between the two groups were even greater , and extended to all six subscale scores ( P < @ ) .


More intervention-group mentors reported changes in their mentoring practices than control mentors ( P < @ ) .


Mentees working with intervention-group mentors reported larger changes in retrospective MCA pre - / posttest scores ( P = @ ) and more changes in their mentors ' behavior ( P = @ ) than those paired with control mentors .


This RCT demonstrates that a competency-based research mentor training program can improve mentors ' skills .


Cardiovascular disease prevention , including lifestyle modification , is important but underutilized .


Mobile health strategies could address this gap but lack evidence of therapeutic benefit .


To examine the effect of a lifestyle-focused semipersonalized support program delivered by mobile phone text message on cardiovascular risk factors .


The Tobacco , Exercise and Diet Messages ( TEXT ME ) trial was a parallel-group , single-blind , randomized clinical trial that recruited @ patients ( mean age , @ -LSB- SD , @ -RSB- years ; @ % men ; @ % current smokers ) with proven coronary heart disease ( prior myocardial infarction or proven angiographically ) between September @ and November @ from a large tertiary hospital in Sydney , Australia .


Patients in the intervention group ( n = @ ) received @ text messages per week for @ months in addition to usual care .


Text messages provided advice , motivational reminders , and support to change lifestyle behaviors .


Patients in the control group ( n = @ ) received usual care .


Messages for each participant were selected from a bank of messages according to baseline characteristics ( eg , smoking ) and delivered via an automated computerized message management system .


The program was not interactive .


The primary end point was low-density lipoprotein cholesterol ( LDL-C ) level at @ months .


Secondary end points included systolic blood pressure , body mass index ( BMI ) , physical activity , and smoking status .


At @ months , levels of LDL-C were significantly lower in intervention participants , with concurrent reductions in systolic blood pressure and BMI , significant increases in physical activity , and a significant reduction in smoking .


The majority reported the text messages to be useful ( @ % ) , easy to understand ( @ % ) , and appropriate in frequency ( @ % ) .


-LSB- table : see text -RSB- .


Among patients with coronary heart disease , the use of a lifestyle-focused text messaging service compared with usual care resulted in a modest improvement in LDL-C level and greater improvement in other cardiovascular disease risk factors .


The duration of these effects and hence whether they result in improved clinical outcomes remain to be determined .


Hydroxyethyl starch ( HES ) is a colloid that has been widely used for fluid resuscitation for decades .


The newest generation of HES , tetrastarch , was believed to provide an efficient volume expansion without causing the side effects observed with former HES solutions .


However , this belief was based on physiological models and small studies rather than on firm clinical evidence .


Our aim was to assess the safety and efficacy of tetrastarch in a randomised clinical trial and in a systematic review .


We first conducted a blinded , clinical trial , in which we randomly assigned patients with severe sepsis in the intensive care unit to fluid resuscitation with either @ % HES @/@ @ ( Tetraspan ) or Ringer 's acetate .


The primary outcome measure was death or dialysis-dependency at @ days after randomisation .


Secondary outcomes described kidney function and serious adverse reactions .


Secondly , we systematically identified all randomised clinical trials comparing tetrastarch with either crystalloid or albumin in patients with sepsis and pooled their results in meta-analyses and trial sequential analyses .


Of the @ patients who underwent randomisation , @ were included in the modified-intention-to-treat population .


At @ days after randomisation , @ of @ patients ( @ % ) assigned to HES @/@ @ had died , as compared with @ of @ patients ( @ % ) assigned to Ringer 's acetate ( relative risk @ , p = @ ) ; @ patient in each group was dialysis-dependent at @ days .


In the @ day observation period , @ patients ( @ % ) assigned to HES received renal replacement therapy vs. @ patients ( @ % ) assigned to Ringer 's acetate ( relative risk @ , p = @ ) , and @ patients ( @ % ) vs. @ patients ( @ % ) had severe bleeding ( relative risk @ , p = @ ) .


Post-hoc sensitivity analysis showed a strongly significant increased risk of any bleeding with HES vs. Ringer 's acetate ( relative risk @ , p = @ ) .


In the systematic review , we identified nine trials that randomised @,@ patients with sepsis .


In meta-analyses , tetrastarch vs. crystalloid or albumin lead to increased use of renal replacement therapy ( relative risk @ , p = @ ) and red blood cells ( relative risk @ , p = @ ) and to more serious adverse events ( relative risk @ , p = @ ) .


Trials with low risk of bias suggested @ % increased risk of death .


After adjusting the results with trial sequential analysis signals for harm persisted .


Our randomised clinical trial is one of several high-quality trials in critically ill patients with and without sepsis that now provide evidence that the use of tetrastarch impairs kidney function and haemostasis and may even increase mortality .


Whether the results can be extrapolated to other types of patients is unclear , but so far no group of patients with an overall benefit of HES beyond surrogate markers has been identified .


In line with this , the European Medicines Agency 's Pharmacovigilance Risk Assessment Committee now recommends that the marketing authorisations of all HES solutions are suspended in the European Union .


The objective of this study was to evaluate the long-term efficacy , safety , and tolerability of paliperidone extended-release ( pali ER ) , in Chinese patients with schizophrenia .


In this parallel-group , relapse prevention , phase-@ study ( screening -LSB- @-day -RSB- , pali ER open-label run-in -LSB- @-week -RSB- and stabilization -LSB- @-week -RSB- phases , and double-blind ( DB ) treatment -LSB- variable duration -RSB- , and open-label extension phases -LSB- @-week -RSB- ) , @/@ patients with schizophrenia were randomized ( @:@ ) to pali ER ( @-@ mg ) or placebo during the DB phase .


Final analysis showed that , out of @ patients in ITT ( DB ) population , @ ( @ % ) had a relapse event , @ ( @ % ) were ongoing at the time the study was stopped , and @ ( @ % ) discontinued from the DB phase .


Time to relapse ( primary endpoint ) favored pali ER ( hazard ratio = @ -LSB- @ % CI : @ , @ -RSB- , p < @ ) .


Rate of relapses ( @/@ -LSB- @ % -RSB- placebo ; @/@ -LSB- @ % -RSB- pali ER ) and secondary endpoints ( change from baseline in Positive And Negative Syndrome Scale -LSB- PANSS -RSB- and Clinical Global Impression - Severity Scores ) were significantly lower ( p < @ ) in pali ER group vs placebo , in favor of pali ER .


More psychiatric-related treatment-emergent adverse events ( TEAEs ) occurred in placebo - ( @ % ) than pali ER group ( @ % ) .


Most common ( > @ % ) TEAEs in placebo group were insomnia and schizophrenia ( @ % each ) , while in pali ER group were aggression and akathisia ( @ % each ) , and schizophrenia , tremor , nausea , amenorrhea , and salivary hypersecretion ( @ % each ) .


All serious TEAEs were psychiatric-related ( schizophrenia , aggression , completed suicide , auditory hallucination , suicide attempt ) and more frequent in placebo - ( @ % ) versus pali ER group ( @ % ) .


Death and tardive dyskinesia-related discontinuation ( n = @ each ) occurred in placebo group .


Body weight increase from run-in baseline was greater in pali ER group ( mean increase : @ kg ) versus placebo ( mean increase : @ kg ) .


This study confirms the findings from earlier pali ER global relapse-prevention studies and demonstrates that pali ER treatment ( @-@ mg ) is efficacious over the long-term and significantly delays relapse in Chinese patients with schizophrenia .


No new safety signals were detected in this population .


Chronic rhinosinusitis is common in cystic fibrosis ( CF ) , as CFTR defects equally affect the airway and sinonasal mucosa .


However , therapeutic strategies for CF-associated chronic rhinosinusitis lag behind current approaches for pulmonary disease .


To assess the tolerability and efficacy of a nasal spray formulation containing @ % sodium hyaluronate and @ % tobramycin compared to a control formulation containing @ % sodium hyaluronate alone in the treatment of bacterial rhinosinusitis in patients with CF.


In a double-blind controlled study , @ patients with an established diagnosis of CF and a documented nasal infection with Pseudomonas aeruginosa and/or Staphylococcus aureus -LSB- @ males ( @ % ) , median age of @ years ( range @-@ yrs ) -RSB- , were randomized to receive the nasal spray formulation containing hyaluronate and tobramycin ( N = @ ) or hyaluronate alone ( N = @ ) for @ days .


Efficacy and local tolerability of the treatments were assessed by ear , nose and throat ( ENT ) examination and related symptoms .


The formulation containing hyaluronate and tobramycin was more effective than hyaluronate alone in improving the status of the nasal mucosa , in reducing the mucopurulent secretion at the level of the osteomeatal complex and in improving ENT symptoms ( hyposmia/anosmia and headache/facial pain ) .


The treatment was well tolerated without relevant side effects .


The present study suggests that the combination therapy with hyaluronate plus tobramycin was more effective than hyaluronate alone in the treatment of bacterial rhinosinusitis in CF.


Early-onset dementia is common in Down syndrome adults , who have trisomy @ .


The amyloid precursor protein gene is on chromosome @ , and so is over-expressed in Down syndrome , leading to amyloid ( A ) over-production , a major upstream pathway leading to Alzheimer disease ( AD ) .


Statins ( microsomal @-hydroxy-@-methylglutaryl coenzyme A reductase inhibitors ) , have pleiotropic effects including potentially increasing brain amyloid clearance , making them plausible agents to reduce AD risk .


Animal models , human observational studies , and small scale trials support this rationale , however , there are no AD primary prevention trials in Down syndrome adults .


In this study we study aim to inform the design of a full-scale primary prevention trial .


TOP-COG is a feasibility and pilot double-blind randomized controlled trial ( RCT ) , with a nested qualitative study , conducted in the general community .


About @ Down syndrome adults , aged @ will be included .


The intervention is oral simvastatin @ mg at night for @ months , versus placebo .


The primary endpoint is recruitment and retention rates .


Secondary endpoints are ( @ ) tolerability and safety ; ( @ ) detection of the most sensitive neurocognitive instruments ; ( @ ) perceptions of Down syndrome adults and caregivers on whether to participate , and assessment experiences ; ( @ ) distributions of cognitive decline , adaptive behavior , general health/quality of life , service use , caregiver strain , and sample size implications ; ( @ ) whether A@/A@ is a cognitive decline biomarker .


We will describe percentages recruited from each source , the number of contacts to achieve this , plus recruitment rate by general population size .


We will calculate summary statistics with @ % confidence limits where appropriate , for each study outcome as a whole , by treatment group and in relation to baseline age , cognitive function , cholesterol and other characteristics .


Changes over time will be summarized graphically .


The sample size for a definitive RCT will be estimated under alternative assumptions .


This study is important , as AD is a major problem for Down syndrome adults , for whom there are currently no effective preventions or treatments .


It will also delineate the most suitable assessment instruments for this population .


Recruitment of intellectually disabled adults is notoriously difficult , and we shall provide valuable information on this , informing future studies .


While antipsychotics are effective in the maintenance treatment of schizophrenia they have safety and tolerability risks .


We investigated whether a combination of omega-@ polyunsaturated fatty acids ( -@ PUFAs ) and a metabolic antioxidant , alpha-lipoic acid ( - LA ) , is effective in preventing relapse after antipsychotic discontinuation in subjects who were successfully treated for @-@ years after a first-episode of schizophrenia , schizo-affective or schizophreniform disorder .


In this randomized , double-blind , placebo controlled study antipsychotic treatment was tapered and discontinued and participants received either -@ PUFAs ( eicosapentaenoic acid @g/day and docosahexaenoic acid @g/day ) + - LA @ mg/day or placebo .


Subjects were followed up for two years , or until relapse .


Recruitment was terminated prematurely due to the high relapse rates in both treatment groups as well as the severity of some of the relapse episodes .


Of the @ participants , @/@ ( @ % ) randomized to -@ PUFAs + - LA relapsed and one ( @ % ) completed two years without relapse ( p = @ ) ; and @/@ ( @ % ) randomized to placebo relapsed and none completed two years without relapse .


Mean times to relapse were @ @ and @ @ weeks for the -@ PUFAs + - LA and placebo groups , respectively ( p = @ ) .


There were no significant differences between the groups in relapse symptom severity .


We found no evidence that -@ PUFAs + - LA could be a suitable alternative to maintenance antipsychotic treatment in relapse prevention , in this small study .


Antipsychotic discontinuation after a single episode of schizophrenia carries a very high risk of relapse , and treatment guidelines endorsing this practice should be revised .


To compare loop excisions of cervical intraepithelial neoplasia grade @ or worse ( CIN @ + ) under video exoscopy , or colposcopic guidance , with respect to safety and effectiveness .


Prospective multicentric randomized trial of @ patients , undergoing loop excision for CIN @ + either under video exoscopy ( group A ) or colposcope ( group B ) guidance .


Intra - and post-operative complications , resection margins , and removed cervical volume in both groups were evaluated .


@ % of patients in video exoscopy group and @ % in colposcopy group ( p = @ ) had transformation zone ( TZ ) @ / @ ( @ % ) of group A patients and @/@ ( @ % ) of group B patients underwent top-hat procedure , i.e. , one superficial excision followed by one deeper removal of the endocervical tissue ( p = @ ) .


There was no difference in intra - and post-operative complications in the two groups .


Positive endocervical resection margins ( R@ ) were @ % in video exoscopy group and @ % in colposcopy group , respectively .


Unclear endocervical resection margins ( Rx ) were @ % in both groups .


Mean total excised cervical volume was @ cubic centimeter ( cc ) in group A , and @ cc in group B , respectively .


Recurrent disease occurred in @ % of patients at @ months follow-up .


Magnification assisted loop excision of CIN @ + is equally effective and safe under colposcopic and video exoscopy guidance .


The latter technique could potentially offer an alternative treatment of CIN @ + lesions for doctors unfamiliar with colposcope .


To investigate the effect of microbial immune enteral nutrition composed of probiotics , deep sea fish oil , glutamine and nutrison on postoperative immune status , insulin resistance and infectious complication morbidity in patients with abdominal infection .


From September @ to April @ in Shandong Liaocheng City Hospital , @ patients with upper gastrointestinal perforation were prospectively randomized into the treatment group ( microbial immune enteral nutrition , n = @ ) and the control group ( conventional enteral nutrition , n = @ ) .


Number of T cell subsets ( CD@ ( + ) , CD@ ( + ) , CD@ ( + ) , CD@ ( + ) / CD@ ( + ) ) and natural killer ( NK ) cell , procalcitonin ( PCT ) , fasting blood glucose ( FBG ) , fasting insulin ( FINS ) , insulin resistance index ( InHOMA-IR ) calculated by the homeostasis model assessment ( HOMA ) were detected before operation and on days @ and @ after operation and compared between the two groups .


The incidence of postoperative infectious complication was collected and compared as well .


There were no significant differences in immune indexes and insulin resistance-associated indexes between the two groups before operation and on the day @ after operation ( all P > @ ) .


On postoperative day @ , CD@ ( + ) , CD@ ( + ) / CD@ ( + ) and NK cells in treatment group were significantly higher than those in control group -LSB- ( @ ) % vs. ( @ ) % , P = @ ; @ vs. @ , P = @ ; ( @ ) % vs. ( @ ) % , P = @ -RSB- , while FINS , lnHOMA-IR and PCT in treatment group were significantly lower than those in control group -LSB- ( @ ) mU/L vs. ( @ ) mU/L , P = @ ; @ vs. @ , P = @ ; ( @ ) g/L vs. ( @ ) g/L , P = @ -RSB- .


Postoperative infectious complication morbidity was significantly lower in treatment group as compared to control group -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P = @ -RSB- .


Microbial immune enteral nutrition composed of probiotics , deep sea fish oil , glutamine and nutrison can improve the immune status , decrease the level of insulin resistance , and reduce the incidence of postoperative infectious complication for patients with abdominal infection due to upper gastrointestinal perforation .


The addition of highly purified eicosapentaenoic acid ( EPA ) to statin therapy prevents cardiovascular events .


However , the impact of this treatment on vulnerable plaques remains unclear .


The aim of this study was to assess the impact of adding EPA to a standard statin therapy on vulnerable plaques by serial optical coherence tomography ( OCT ) .


Forty-nine non-culprit thin-cap fibroatheroma ( TCFA ) lesions in @ patients with untreated dyslipidemia were included .


Patients were randomly assigned to EPA ( @ mg/day ) + statin ( @ TCFA , @ patients ) or statin only ( @ TCFA , @ patients ) treatment .


The statin ( rosuvastatin ) dose was adjusted to achieve a target low-density lipoprotein ( LDL ) level of < @ mg/dL .


Post-percutaneous intervention and @-month follow-up OCT were performed to evaluate morphological changes of TCFAs .


The EPA/arachidonic acid ( EPA/AA ) ratio and pentraxin-@ ( PTX@ ) levels were also evaluated .


Despite similar follow-up LDL levels , the EPA + statin group had higher EPA/AA ratios and lower PTX@ levels than the statin group .


OCT analysis showed that the EPA + statin group had a greater increase in fibrous-cap thickness , with a greater decrease in lipid arc and lipid length .


Macrophage accumulation was less frequently detected in the EPA + statin group than in the statin group at follow-up .


When the patients were categorized according to their follow-up PTX@ tertiles , fibrous-cap thickness showed significant increase , and the incidence of macrophages accumulation decreased with lower PTX@ levels .


The concomitant use of EPA and rosuvastatin may stabilize vulnerable plaques better than the statin alone , possibly by suppressing arterial inflammation .


The American Board of Internal Medicine Foundation Choosing Wisely Campaign recommends against the use of benzodiazepine drugs for adults @ years and older .


The effect of direct patient education to catalyze collaborative care for reducing inappropriate prescriptions remains unknown .


To compare the effect of a direct-to-consumer educational intervention against usual care on benzodiazepine therapy discontinuation in community-dwelling older adults .


Cluster randomized trial ( EMPOWER -LSB- Eliminating Medications Through Patient Ownership of End Results -RSB- study -LSB- @-@ , @-month follow-up -RSB- ) .


Community pharmacies were randomly allocated to the intervention or control arm in nonstratified , blocked groups of @ .


Participants ( @ long-term users of benzodiazepine medication aged @-@ years , recruited from @ community pharmacies ) were screened and enrolled prior to randomization : @ pharmacies randomized to the educational intervention included @ participants and @ pharmacies randomized to the `` wait list '' control included @ participants .


Participants , physicians , pharmacists , and evaluators were blinded to outcome assessment .


The active arm received a deprescribing patient empowerment intervention describing the risks of benzodiazepine use and a stepwise tapering protocol .


The control arm received usual care .


Benzodiazepine therapy discontinuation at @ months after randomization , ascertained by pharmacy medication renewal profiles .


A total of @ participants ( @ % ) completed the @-month follow-up .


Of the recipients in the intervention group , @ % initiated conversation about benzodiazepine therapy cessation with a physician and/or pharmacist .


At @ months , @ % of the intervention group had discontinued benzodiazepine use compared with @ % of the control group ( risk difference , @ % -LSB- @ % CI , @ % -@ % -RSB- ; intracluster correlation , @ ; number needed to treat , @ ) .


Dose reduction occurred in an additional @ % ( @ % CI , @ % -@ % ) .


In multivariate subanalyses , age greater than @ years , sex , duration of use , indication for use , dose , previous attempt to taper , and concomitant polypharmacy ( @ drugs or more per day ) did not have a significant interaction effect with benzodiazepine therapy discontinuation .


Direct-to-consumer education effectively elicits shared decision making around the overuse of medications that increase the risk of harm in older adults .


Efficacy and safety of sugammadex in reversing neuromuscular block induced by rocuronium or vecuronium were investgated in Japanese patients .


We studied @ Japanese patients undergoing surgery requiring general anesthesia .


Patients were allocated randomly to receive intubation dose of rocuronium or vecuronium .


During surgery , patients received additional doses of rocuronium or vecuronium for maintenance of moderate block .


At T@ reappearance sugammadex @-@ @ mg .


kg-@ was administered .


The neuromuscular block was monitored with acceleromyography using TOF stimuli .


Sevoflurane was administered to all treatment groups after intubation .


For the rocuronium-induced neuromuscular block , the mean recovery time of the T@/T@ ratio to @ decreased from @ min in the placebo group to @ min in the @ mg .


kg-@ sugammadex group .


For the vecuronium-induced neuromuscular block , it decreased from @ min in the placebo group to @ min in the sugammadex @ mg .


kg-@ group .


Plasma concentrations of sugammadex were approximately dose proportional over the dose range of @ to @ mg .


kg-@ and independent of the neuromuscular blocking agents used .


No clinical evidence of recurarization or residual curarization was observed .


The efficacy and safety of sugammadex were confirmed in Japanese surgical patients .


The plasma @-hydroxyvitamin D response to supplementation with vitamin D varies widely , but vitamin D absorption differences based on diet composition is poorly understood .


We tested the hypotheses that absorption of vitamin D-@ is greater when the supplement is taken with a meal containing fat than with a fat-free meal and that absorption is greater when the fat in the meal has a higher monounsaturated-to-polyunsaturated fatty acid ratio ( MUFA : PUFA ) .


Open , three-group , single-dose vitamin D-@ comparative absorption experiment .


Our @-day study was conducted in @ healthy older men and women who were randomly assigned to one of three meal groups : fat-free meal , and a meal with @ % of calories as fat with a low ( @:@ ) and one with a high ( @:@ ) MUFA : PUFA .


After a @-hour fast , all subjects took a single @,@ IU vitamin D-@ supplement with their test breakfast meal .


Plasma vitamin D-@ was measured by liquid chromatography-mass spectrometry before and @ , @ ( the expected peak ) , and @ hours after the dose .


Means were compared with two-tailed t tests for independent samples .


Group differences in vitamin D-@ absorption across the measurement time points were examined by analysis of variance with the repeated measures subcommand of the general linear models procedure .


The mean peak ( @-hour ) plasma vitamin D-@ level after the dose was @ % ( @ % CI @ % to @ % ) greater in subjects consuming fat-containing compared with fat-free meals ( P = @ ) .


Absorption did not differ significantly at any time point in the high and low MUFA and PUFA groups .


The presence of fat in a meal with which a vitamin D-@ supplement is taken significantly enhances absorption of the supplement , but the MUFA : PUFA of the fat in that meal does not influence its absorption .


It is not clear whether demographic or pterygium characteristics or limbal stem cell deficiency determine pterygium recurrence after surgery .


To determine whether the demographic , pterygium characteristics , or limbal stem cell deficiency determine pterygium recurrence after excision .


Of @ patients operated and followed-up for @ months , @ and @ underwent free conjunctival autotransplant ( CAT ) or limbal conjunctival autotransplant ( LCAT ) respectively .


The age , gender , occupation , grade of pterygium extent and degree of fleshiness , and laterality were compared between recurrent and no recurrent pterygia .


Multivariate analysis was performed to determine the predictors of pterygium recurrence .


Recurrence rates after surgery were compared between CAT and LCAT .


The age range of the @ patients was @-@ years , mean SD @ @ years .


Pterygium recurred in @ ( @ % ) .


Thirty-nine ( @ % ) of @ patients with pterygia that recurred were aged < @ years ( young ) vs. @ ( @ % ) of @ young patients with no recurrence ; odds ratio ( OR ) = @ ; @ % confidence interval ( @ % CI ) = @-@ @ ; p = @ .


Thirty-one ( @ % ) of @ participants with post-surgical recurrent pterygia had large pre-operative pterygium ( grade @ ) vs. @ ( @ % ) of @ patients with large pterygia that did not recur ; OR = @ ; @ % CI = @-@ @ ; p < @ .


Of @ patients undergoing CAT , @ ( @ % ) experienced recurrence vs. @ ( @ % ) of @ undergoing LCAT ; p = @ .


Young age seems to be associated with pterygium recurrence after excision followed by conjunctival graft .


Large pterygia were protective .


To compare the efficacy of a regimen combining mental practice ( MP ) with overground training ( OT ) with the efficacy of a regimen consisting of OT only on gait velocity and lower extremity motor outcomes in individuals with chronic ( > @mo postinjury ) , incomplete spinal cord injury ( SCI ) .


Randomized , controlled , single-blinded study .


Outpatient rehabilitation laboratories .


Subjects with chronic , incomplete SCI ( N = @ ) .


Subjects were randomly assigned to receive ( @ ) OT only , occurring @d/wk for @ weeks ; or ( @ ) OT augmented by MP ( MP + OT ) , during which randomly assigned subjects listened to an MP audio recording directly after OT sessions .


Subjects were administered a test of gait velocity as well as the Tinetti Performance Oriented Mobility Assessment , Spinal Cord Injury Independence Measure , and Satisfaction With Life Scale on @ occasions before intervention , @ week after intervention , and @ weeks after intervention .


A significant increase in gait velocity was exhibited across subjects at both @ week posttherapy ( P = @ ) and at @ weeks posttherapy ( P = @ ) .


However , no differences were seen in intervention response at either @ or @ weeks postintervention among subjects in the MP + OT group versus the OT-only group .


OT was associated with significant gains in gait velocity , and these gains were not augmented by further addition of MP .


Gastric ulceration is highly prevalent in horses , and there is a large commercial market for feed-additives and non-licenced products that claim effect for prevention and treatment of gastric ulceration .


ImproWin has been used as a feed additive in horses with anecdotal evidence that it may have some positive effects on gastric ulceration.The aim of this study was to investigate the effect of ImproWin treatment on spontaneously occurring gastric ulcers of the squamous mucosa in Standardbred and Coldblooded trotting racehorses .


The study was performed as a randomised , double-blinded , single centre study with stratified semi cross-over design with breed as stratification factors .


The horses were clinically and endoscopically examined prior to start and after three weeks of treatment .


The ulcerations were scored in accordance with Equine Gastric Ulcer Council ( EGUC ) recommendations on a @ point scale and on a @ cm Visual Analogue Scale ( VAS ) .


The patients were responder-classified after @ weeks .


Responders in need of ulcer treatment were randomly allocated to @ or @ weeks of additional treatment .


Non-responders to placebo were crossed to ImproWin .


The @-point EGUC score and VAS recorded score was significantly reduced ( P@ @ ) in both groups after @ weeks of treatment .


From @ weeks to the end of treatment the score was further significantly reduced in the ImproWin group ( P@ @ ) .


At the end of treatment , @ % in the ImproWin group and @ % in the placebo group were classified as responders .


The difference was significant ( P = @ ) .


ImproWin may aid the healing process of ulcers of the gastric squamous mucosa of trotters .


The oral neurokinin-@ antagonist aprepitant is recommended in several guidelines for preventing chemotherapy-induced nausea & vomiting ( CINV ) due to highly emetogenic cancer chemotherapy .


Little is known about the feasibility and safety of aprepitant in patients treated with oxaliplatin .


In this multicentre , open label , randomised , phase @ trial , we recruited patients with colorectal cancer who underwent an oxaliplatin-based chemotherapy .


Patients were centrally randomised in a @:@ ratio to the control group ( @-HT@-receptor antagonist + dexamethasone ) or aprepitant group ( @-HT@-receptor antagonist + dexamethasone + aprepitant or fosaprepitant ) in the first course .


All patients were treated with aprepitant/fosaprepitant therapy in the second course .


The primary end-point was the proportion of patients with no emesis .


A total of @ patients entered this clinical trial from @ centres in Japan .


Significantly more patients in the aprepitant group achieved no vomiting overall and delayed phase than those in the control group ( @ % versus @ % , and @ % versus @ % , respectively ) .


The aprepitant group also had statistically significantly higher percentages of no significant nausea , complete response and complete protection than the control group overall .


In the control group , the percentages of no vomiting were higher in the second cycle than in the first cycle .


The incidence of vomiting occurred day @ or later was significantly higher in the control group compared with the aprepitant group .


Other adverse events were not significant between the groups .


The aprepitant therapy was more effective than the control therapy for prevention of CINV in colorectal cancer patients receiving an oxaliplatin-based regimen .


Research has documented the very brief exposure ( VBE ) effect : the reduction of phobic fear by continuous presentation of masked phobic pictures .


In prior studies , phobic participants approached a live tarantula immediately after the masked stimuli were presented .


This study tested the hypothesis that VBE would reduce phobic avoidance of the tarantula @ h later .


@ spider-phobic participants were identified with a fear questionnaire and Behavioral Avoidance Test ( BAT ) with a live tarantula indicative of a DSM-IV diagnosis of Specific Phobia .


One week later , they were randomly assigned in double-blind fashion to presentation of a continuous series of @ trials of masked images of either spiders or flowers ( @-ms each ) , i.e. , to VBE or control exposure .


The participants gave subjective distress ratings just before and after these exposures .


Then they engaged in the BAT again either immediately thereafter or @ h later to measure changes in avoidance of the tarantula .


Masked images of spiders reduced avoidance of the tarantula both immediately after exposure and @ h later without causing subjective distress .


The effect sizes at these two time points did not significantly differ from each other .


We did not manipulate awareness of the spider images by presenting them unmasked to a third group .


Conclusions about the effect of awareness of the stimuli can not be drawn .


VBE induces a process of fear reduction before phobic individuals engage in in vivo exposure , which is more distressing .


Thus , VBE may help phobic-resistant individuals start treatment more gradually .


In patients with ST-segment elevation myocardial infarction ( STEMI ) triaged to primary percutaneous coronary intervention ( PCI ) , anticoagulation often is initiated in the ambulance during transfer to a PCI site .


In this prehospital setting , bivalirudin has not been compared with standard-of-care anticoagulation .


In addition , it has not been tested in conjunction with the newer P@Y@ inhibitors prasugrel or ticagrelor .


EUROMAX is a randomized , international , prospective , open-label ambulance trial comparing bivalirudin with standard-of-care anticoagulation with or without glycoprotein IIb/IIIa inhibitors in @ patients with STEMI and intended for primary percutaneous coronary intervention ( PCI ) , presenting either via ambulance or to centers where PCI is not performed .


Patients will receive either bivalirudin given as a @ mg/kg bolus followed immediately by a @-mg / kg per hour infusion for @ minutes prior to primary PCI and continued for @ hours after the end of the procedure at the reduced dose of @ mg/kg per hour , or heparins at guideline-recommended doses , with or without routine or bailout glycoprotein IIb/IIIa inhibitor treatment according to local practice .


The primary end point is the composite incidence of death or non-coronary-artery-bypass-graft related protocol major bleeding at @ days by intention to treat .


The EUROMAX trial will test whether bivalirudin started in the ambulance and continued for @ hours after primary PCI improves clinical outcomes compared with guideline-recommended standard-of-care heparin-based regimens , and will also provide information on the combination of bivalirudin with prasugrel or ticagrelor .


Few clinical studies have focused on the efficacy of lipid-lowering therapies in patients @ years .


After stabilization on atorvastatin @ mg , hypercholesterolemic subjects @ years at high/very high risk for CHD and not at LDL-C < @ mmol/L ( with atherosclerotic vascular disease -LSB- AVD -RSB- ) or < @ mmol/L ( without AVD ) were randomized to ezetimibe @ mg plus atorvastatin @ mg or uptitration to atorvastatin @ mg ( @ weeks ) followed by uptitration to @ mg ( additional @ weeks ) .


A post-hoc analysis compared between-group differences in percent attainment of individual and combined LDL-C , non-HDL-C and Apo B targets based on recommendations from @ European and Canadian Cardiovascular Society ( CCS ) guidelines for dyslipidemia treatment .


Atorvastatin @ mg plus ezetimibe produced significantly greater attainment of LDL-C , non-HDL-C , and Apo B individual and dual/triple targets vs. atorvastatin @ mg for the entire cohort and very high-risk groups at @ weeks .


After @ weeks , very high-risk subjects maintained significantly greater achievement of LDL-C < @ mmol/L ( @ % vs. @ % ) , non-HDL-C < @ mmol/L ( @ % vs. @ % ) and Apo B < @ g/L ( @ % vs. @ % ) single targets and dual/triple targets with atorvastatin @ mg plus ezetimibe vs. atorvastatin @ mg , while attainment of European target for high-risk subjects was generally similar for both treatments .


Achievement of Canadian targets was significantly greater with combination therapy vs. atorvastatin @ mg ( @ weeks ) or atorvastatin @ mg ( @ weeks ) .


Atorvastatin @ mg plus ezetimibe provided more effective treatment than uptitration to atorvastatin @/@ mg for attainment of most European and Canadian guideline-recommended lipid targets in older at-risk patients .


Aspiration thrombectomy in ST-segment elevation myocardial infarction is recommended by current guidelines based on several randomized trials .


There are no trials assessing thrombectomy in non-ST-segment elevation myocardial infarction ( NSTEMI ) patients .


The TATORT-NSTEMI ( Thrombus Aspiration in Thrombus Containing Culprit Lesions in Non-ST-Elevation Myocardial Infarction ) trial sought to assess the effect of aspiration thrombectomy on microvascular injury in patients with NSTEMI compared with standard percutaneous coronary intervention ( PCI ) .


This prospective , controlled , multicenter study randomized @ patients to adjunctive thrombectomy ( n = @ ) compared with conventional PCI ( n = @ ) in NSTEMI patients with thrombus-containing lesions .


The primary endpoint of the extent of microvascular obstruction ( MO ) in the percentage of left ventricular mass ( % LV ) was assessed by cardiac magnetic resonance imaging within @ days .


Secondary endpoints included infarct size , myocardial salvage index , and angiographic parameters including myocardial blush grade and Thrombolysis In Myocardial Infarction flow grade .


The combined clinical endpoint consisted of death , reinfarction , target vessel revascularization , and new congestive heart failure within @ months .


The primary endpoint of MO was not different between the thrombectomy and the standard PCI group with @ % LV ( interquartile range -LSB- IQR -RSB- : @ to @ ) versus @ % LV ( IQR : @ to @ ) ( p = @ ) .


Similarly , no significant differences were observed for infarct size ( @ % LV ; IQR : @ to @ vs. @ % LV ; IQR : @ to @ ; p = @ ) , myocardial salvage index ( @ ; IQR : @ to @ vs. @ ; IQR : @ to @ ; p = @ ) , or angiographic parameters such as blush grade ( p = @ ) and Thrombolysis In Myocardial Infarction flow grade ( p = @ ) .


Clinical follow-up at @ months revealed no differences in the combined clinical endpoints ( p = @ ) .


Aspiration thrombectomy in conjunction with PCI in NSTEMI with a thrombus-containing lesion does not lead to a reduction in MO. ( Thrombus Aspiration in Thrombus Containing Culprit Lesions in Non-ST-Elevation Myocardial Infarction -LSB- TATORT-NSTEMI -RSB- ; NCT@ ) .


The aim of this study was to examine the relationship between mastery motivation and individual and environmental characteristics in school-aged children with congenital hemiplegia .


Forty-eight child-caregiver dyads ( children 's mean age @y @mo , SD @y @mo ; @ males , @ females ; Manual Ability Classification System -LSB- MACS -RSB- level I , n = @ , and level II , n = @ ; predominant motor type spastic hemiplegia , n = @ ) were recruited to this cross-sectional study .


Children were assessed using the Melbourne Assessment of Unilateral Upper Limb Function ( MUUL ) and the Assisting Hand Assessment .


Caregivers completed the Dimensions of Mastery Questionnaire , the Parenting Scale , and a demographic questionnaire .


Consistent and positive parental disciplinary practices were associated with higher total motivation ( p = @ ) and instrumental aspect scores ( p = @ ) .


Children with siblings and from single-parent families experienced greater negative reactions to failure ( p = @ ) .


Children from two-parent families ( p = @ ) and with better bimanual performance ( p = @ ) demonstrated greater object-oriented persistence .


Age , sex , limitations in manual ability ( MACS ) , and movement and body function of the impaired limb ( MUUL ) did not contribute significantly to mastery motivation .


Inconsistent , excessively lax , and verbose parenting practices may discourage children from persevering with challenging tasks .


Functional parenting styles , positive discipline practices , and autonomy-supportive strategies for task engagement should be encouraged when intervening with children with cerebral palsy .


Parents should be supported to engage in these practices in all aspects of daily activities .


To compare the effect of wavefront-guided ( WFG ) and wavefront-optimized ( WFO ) photorefractive keratectomy ( PRK ) on patient perceived quality of vision .


Seventy-one patients ( @ eyes ) were enrolled in this prospective , randomized , fellow eye controlled study .


One eye was randomized to undergo WFG PRK treatment by the AMO Visx CustomVue S@ IR excimer laser system ( Abbott Medical Optics , Inc. , Santa Clara , CA ) and the fellow eye received WFO PRK treatment by the Alcon Allegretto Wave Eye-Q @ Hz excimer laser system ( Alcon Laboratories , Inc. , Fort Worth , TX ) .


Patients answered questionnaires on their visual symptoms and quality of vision preoperatively and at @ , @ , @ , and @ months after surgery .


Patients in both groups reported better vision compared to baseline from @ months onward ( mean change in score of @ to @ in the WFO group and @ to @ in the WFG group , P @ ) .


Both groups experienced less nighttime glare from @ months onward ( P @ ) .


Halos , double vision , and visual clarity were initially worse ( P @ ) but not significantly different after @ month .


Haze and fluctuating vision resolved after @ months .


Visual symptoms were similar between the two groups at all times ( P @ ) except at @ months , when patients felt their WFG eyes had more excellent vision ( P = @ ) .


A composite of all symptoms was also similar between the groups until @ months when patients had fewer symptoms in their WFO eye ( P = @ ) .


One year after surgery , patient self-reported visual symptoms were not significantly different in eyes receiving WFG or WFO PRK .


However , the average of all symptoms was lower in eyes receiving wavefront-optimized treatment .


Because of lack of information regarding timing of stroke , patients who suffer stroke during sleep are generally ineligible for intravenous thrombolysis , although many of these patients could potentially recover with this treatment .


Magnetic resonance image findings with positive diffusion-weighted imaging and no marked parenchymal hyperintensity on fluid-attenuated inversion recovery ( negative pattern ) can identify acute ischemic stroke patients within @h from symptom onset .


The THrombolysis for Acute Wake-up and unclear-onset Strokes with alteplase at @mg/kg trial aims to determine the efficacy and safety of intravenous thrombolysis with alteplase at @mg/kg body weight , the approved dose for Japanese stroke patients , using magnetic resonance image-based selection in ischemic stroke patients with unclear time of symptom onset , and compare findings with standard treatment .


This is an investigator-initiated , multicenter , prospective , randomized , open-treatment , blinded-end-point clinical trial .


The design is similar to the Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke trial .


Patients with unclear-onset time of stroke symptoms beyond @h and within @h after the time of the last-known-well period and within @h after symptom recognition , who showed a negative fluid-attenuated inversion recovery pattern , are randomized to either intravenous thrombolysis or standard treatment .


The primary efficacy end-point is modified Rankin Scale @-@ at @ days .


The safety outcome measures are symptomatic intracranial hemorrhage at @-@h , and major bleeding and mortality at @ days .


This trial may help determine if low-dose alteplase at @mg/kg should be recommended as a routine clinical strategy for ischemic stroke patients with unclear-onset time .


Ulcers of the heel in diabetes are the source of considerable suffering and cost .


In the absence of specific treatments , it has been suggested that removable , lightweight fibreglass heel casts may both promote healing and reduce discomfort and pain .


The aim of the study is to assess the effectiveness and cost-effectiveness of fibreglass heel casts in the management of heel ulcers .


This is an observer-blind , randomised controlled trial in which participants with diabetes and heel ulcers ( NPUAP/EPUAP grades @ , @ or @ and present for @ or more weeks ) are randomised to receive either usual care plus lightweight fibreglass heel casts or usual care alone .


Randomisation is undertaken by random number sequence generation incorporated as part of the electronic case record form , and is stratified by both ulcer area ( less than versus equal to or greater than @ cm ( @ ) ) and NPUAP/EPUAP grade .


Participants are followed every two weeks until healing or for @ weeks .


The primary outcome measure is healing at or before @ weeks and maintained for @ weeks .


Secondary outcomes include ( i ) ulcer-related outcomes : time to healing , change in ulcer area , minor and major amputation , secondary infection and ( ii ) patient-related outcomes : local pain , mood and function ( EQ-@D ) , impact of the ulcer ( Cardiff Wound Impact Schedule ) and survival .


Cost-effectiveness will be assessed using a decision analytic model to estimate costs from the perspective of the UK NHS and personal social services and health outcomes , including percent healing and Quality Adjusted Life Years gained.Safety will be documented as adverse and serious adverse device effects .


If it is possible to confirm significant clinical benefit and/or cost-effectiveness , this would have direct implications for the management of this distressing and costly complication of diabetes


To determine if abobotulinumtoxin A ( AboBTXA ) is an effective treatment for interstitial cystitis/bladder pain syndrome ( IC/BPS ) .


We performed a double-blind study of @ women with severe , refractory IC from three referral centres whom we randomly allocated to treatment with hydrodistension + injection of normal saline or to hydrodistension + injection with AboBTXA .


The O'Leary-Sant questionnaire consists of problem ( OLS-PI ) and symptom ( OLS-PI ) index scores , and bladder diary data were compared between AboBTXA and control patients at baseline and at @ months of follow-up .


Measurements were made beyond @ months , but no further randomised comparison was possible due to the ability of nonresponsive patients in either group to have AboBTXA treatment .


Complete data were available in @ patients , and in both groups , OLS questionnaires showed improvement at @ months .


Only the OLS-PI was improved in the AboBTXA group ( p = @ ) .


At @ months , no difference was found in either OLS-SI or total OLS score .


Twelve patients had urinary tract infection ( UTI ) treated during the follow-up period , which confounded results .


In the @ patients without UTI , there was improvement in total OLS score ( p = @ ) , OLS-PI ( @ ) , and OLS-SI ( p = @ ) for the AboBTXA group at @ months .


Only five AboBTXA compared with two control patients had a @ % reduction in OLS score .


For chronic refractory IC/BPS patients , AboBTXA was associated with no overall improvement in total OLS score , although significant benefit was noted in a small number of patients .


The absence of posttreatment UTI was associated with a better response to AboBTXA .


To evaluate the baseline impact of episode type ( manic vs. mixed ) , defined using DSM-IV-TR criteria , in bipolar I disorder ( BD-I ) on health-related quality of life ( HRQoL ) , and to investigate the differential effect of asenapine vs. placebo and olanzapine on HRQoL in BD-I patients with mixed episodes .


In two identically designed @ week , randomized , double-blind , flexible-dose , placebo - and olanzapine-controlled trials of asenapine , HRQoL was assessed using the @-item Short-Form Health Survey ( SF-@v@ ) administered at baseline and endpoint .


In addition to evaluating the impact of clinical presentation ( manic vs. mixed episodes ) on baseline HRQoL , the impact of treatment intervention on HRQoL was assessed via analysis of covariance models at study endpoint , with center and treatment-by-diagnosis interaction as fixed effect and baseline score as covariates .


A total of @ BD-I patients ( asenapine : @ ; olanzapine : @ ; placebo : @ ) were included in the two studies .


The observed burden of disease on HRQoL was substantial compared to general US population norms , particularly in patients experiencing mixed episodes .


The greatest impairments were observed in the mental domains of HRQoL ( Mental Component Summary scores : mixed = @ ; manic = @ ) .


For patients with mixed episodes , when compared to olanzapine , asenapine treatment was associated with improvements noted in every domain , which did not reach statistical significance except for Vitality ( asenapine = @ , olanzapine = @ ; p = @ ) and Role-Emotional ( asenapine = @ , olanzapine = @ ; p = @ ) .


Compared to placebo patients with mixed episodes , asenapine treatment provided significant improvements ( p < @ ) in Bodily Pain ( asenapine = @ , placebo = @ ) , Social Functioning ( asenapine = @ , placebo = @ ) and Mental Health ( asenapine = @ , placebo = @ ) by Week @ ; by comparison , olanzapine treatment did not lead to significant improvements in any domain of HRQoL compared to placebo .


Post-hoc analyses of two trials showed that BD-I patients with mixed episodes reported considerable impairments in HRQoL compared to patients with manic episodes .


At @ weeks , in patients with mixed episodes , asenapine was shown to lead to significant improvements in HRQoL compared to olanzapine and placebo .


Results from these post-hoc analyses should be confirmed in prospective studies .


Low back pain is a common , disabling musculoskeletal disorder in both developing and developed countries .


Although often recommended , the potential efficacy of massage therapy in general , and Chinese massage ( tuina ) in particular , for relief of chronic low back pain ( CLBP ) has not been fully established due to inadequate sample sizes , low methodological quality , and subclinical dosing regimens of trials to date .


Thus , the purpose of this randomized controlled trial ( RCT ) is to evaluate the comparative effectiveness of tuina massage therapy versus conventional analgesics for CLBP .


The present study is a single center , two-arm , open-label RCT .


A total of @ eligible CLBP patients will be randomly assigned to either a tuina treatment group or a conventional drug control group in a @:@ ratio .


Patients in the tuina group receive a @ minutes , @-step treatment protocol which includes both structural and relaxation massage , administered in @ sessions over a period of @ weeks .


Patients in the conventional drug control group are instructed to take a specific daily dose of ibuprofen .


The primary outcome measure is the change from baseline back pain and function , measured by Roland-Morris Disability Questionnaire , at two months .


Secondary outcome measures include the visual analogue scale , Japanese orthopedic association score ( JOAS ) , and McGill pain questionnaire .


The design and methodological rigor of this trial will allow for collection of valuable data to evaluate the efficacy of a specific tuina protocol for treating CLBP .


This trial will therefore contribute to providing a solid foundation for clinical treatment of CLBP , as well as future research in massage therapy .


Chronic pain is common among the older population .


A literature review on pain management program showed that exercise , yoga , massage therapy , Tai Chi , and music therapy could significantly reduce pain .


In spite of the proven benefits of pain management programs , these intervention programs were effective only in the short term , and older adults would resume their old habits .


It has been suggested that interventions comprising some type of social support have great potential to increase the participation of older adults .


Therefore , we propose the inclusion of peer volunteers in an integrated pain management program to relieve pain among frail older adults .


This study aims to explore the effectiveness of an integrated pain management program supplemented with peer volunteers in improving pain intensity , functional mobility , physical activity , loneliness levels , happiness levels , and the use of non-pharmacological pain-relieving methods among frail older adults with chronic pain .


We intend to recruit @ nursing home residents and @ peer volunteers from the Institute of Active Ageing in Hong Kong in a group trial for an @-week group-based integrated pain management program .


There will be @ sessions , with two @-hour sessions each week.The primary outcome will be pain levels , while secondary outcomes will be assessed according to functional mobility , physical activity , loneliness levels , happiness levels , the use of non-pharmacological pain-relieving methods , and through a questionnaire for volunteers .


In view of the high prevalence of chronic pain among older adults and its adverse impacts , it is important to provide older adults with tools to control their pain .


We propose the use of peer volunteers to enhance the effects of an integrated pain management program .


It is expected that pain can be reduced and improvements can be achieved among older adults in the areas of physical activity , functional mobility , loneliness levels , happiness levels , and the use of non-pharmacological pain relieving methods .


Using these results , we will assess the need to conduct a larger study with a randomized controlled design .


Moderate alcohol consumption is associated with a decrease in cardiovascular risk , but fermented beverages seem to confer greater cardiovascular protection due to their polyphenolic content .


Circulating endothelial progenitor cells ( EPC ) are bone-marrow-derived stem cells with the ability to repair and maintain endothelial integrity and function and are considered as a surrogate marker of vascular function and cumulative cardiovascular risk .


Nevertheless , no study has been carried out on the effects of moderate beer consumption on the number of circulating EPC in high cardiovascular risk patients .


To compare the effects of moderate consumption of beer , non-alcoholic beer and gin on the number of circulating EPC and EPC-mobilizing factors .


In this crossover trial , @ men at high cardiovascular risk were randomized to receive beer ( @ g alcohol/d ) , the equivalent amount of polyphenols in the form of non-alcoholic beer , or gin ( @ g alcohol/d ) for @ weeks .


Diet and physical exercise were carefully monitored .


The number of circulating EPC and EPC-mobilizing factors were determined at baseline and after each intervention .


After the beer and non-alcoholic beer interventions , the number of circulating EPC significantly increased by @ and @ units , respectively , while no significant differences were observed after the gin period .


In correlation , stromal cell derived factor @ increased significantly after the non-alcoholic and the beer interventions .


The non-alcoholic fraction of beer increases the number of circulating EPC in peripheral blood from high cardiovascular risk subjects .


School-based programs , such as Playworks , that guide students in organized activities during recess and make improvements to the recess play yard may lead to significant increases in physical activity-especially for girls .


This study builds on past research by investigating the impact of Playworks separately for girls and boys .


Twenty-nine schools were randomly assigned to receive Playworks for @ school year or serve as a control group .


Postintervention physical activity data were collected via accelerometers and recess observations .


Impacts were estimated separately for girls and boys using regression models .


Girls in Playworks schools had significantly higher accelerometer intensity counts and spent more time in vigorous physical activity than girls in control schools .


No significant differences based on accelerometer data were found for boys .


A significant impact was also found on the types of activities in which girls engaged during recess ; girls in the treatment group were less likely than those in the control group to be sedentary and more likely to engage in jumping , tag , and playground games .


The current findings suggest that Playworks had a significant impact on some measures of girls ' physical activity , but no significant impact on measures of boys ' physical activity .


To compare the effects of @ % hypertonic saline and @ % mannitol in doses of similar osmotic burden for treatment of intracranial hypertension in patients with severe traumatic brain injury .


We used an alternating treatment protocol to compare the effects of hypertonic saline with that of mannitol given for episodes of increased intracranial pressure ( ICP ) in patients with severe brain injury .


Standard guidelines for the management of severe traumatic brain injury were followed .


For episodes of increased ICP , @ % mannitol ( @ ml/kg , infused for over @ min ) and @ % saline ( @ ml/kg , administered as a bolus via a central venous catheter ) of similar osmotic burden were given alternately , with the choice of agent for the initial hypertensive event determined on a randomized basis .


Reduction of ICP and duration of the action were recorded after each event .


The data were collected from @ patients with @ hypertensive events .


The mean decrease in ICP was @ mm Hg at @ min after mannitol treatment as compared with @ mm Hg at @ min after treatment with hypertonic saline ( P > @ ) .


The mean duration of the effect was @ min for mannitol and @ min for hypertonic saline ( P > @ ) .


Treatment with @ % hypertonic saline and @ % mannitol in doses of similar osmotic burden produces similar effects in management of increased ICP in patients with severe traumatic brain injury in terms of the time of action onset , maximum ICP reduction , and duration of action .


We have previously shown that in patients with asthma a single dose of an inhaled glucocorticosteroid ( ICS ) acutely potentiates inhaled albuterol-induced airway vascular smooth muscle relaxation through a nongenomic action .


An effect on airway smooth muscle was not seen , presumably because the patients had normal lung function .


The purpose of the present study was to conduct a similar study in patients with asthma with airflow obstruction to determine if an ICS could acutely also potentiate albuterol-induced airway smooth muscle relaxation in them .


In @ adult patients with asthma ( mean SE baseline FEV@ , @ % @ % ) , the response to inhaled albuterol ( @ g ) was assessed by determining the change in FEV@ ( FEV@ ) for airway smooth muscle and in airway blood flow ( Qaw ) for airway vascular smooth muscle measured @ min after drug inhalation .


Using a double-blind design , the patients inhaled a single dose of the ICS mometasone ( @ g ) or placebo simultaneously with or @ min before albuterol inhalation .


After simultaneous drug administration , mean FEV@ was @ @ L ( @ % ) after placebo and @ @ L ( @ % ) after mometasone ( P < @ ) ; mean Qaw was -@ % after placebo and @ % after mometasone ( P < @ ) .


When mometasone or placebo was administered @ min before albuterol , there was a lesser and insignificant difference in FEV@ between the two treatments , whereas the difference in Qaw remained significant .


This pilot study showed that in adult patients with asthma with airflow obstruction , a single standard dose of an ICS can acutely increase the FEV@ response to a standard dose of inhaled albuterol administered simultaneously .


The associated potentiation of albuterol-induced vasodilation in the airway was of greater magnitude and retained when the ICS was administered @ min before albuterol .


The clinical significance of this observation will have to be established by a study involving a larger patient cohort .


Hidradenitis suppurativa ( HS ) , is a chronic , recurrent dermatosis affecting skin that contains apocrine glands .


Photodynamic therapy using aminolaevulinic acid ( ALA ) activated by intense pulsed light ( IPL ) have shown variable success rates , with some adverse effects .


To evaluate the efficacy and safety of methylene blue ( MB ) as a photosensitizer delivered as a niosomal gel for the treatment of HS using IPL .


We enrolled @ patients with HS in the study , which was a randomized split-body study .


One side of each patient 's body was treated with niosomal MB ( NMB ) gel and the other side was treated with unloaded ( free ) MB ( FMB ) gel .


The affected sites were irradiated using IPL with a @ nm filter .


Patients were followed up at @ , @ and @ months after treatment .


Drug release from the FMB gel was significantly higher ( P > @ ) than from the NMB gel .


Lesions showed @ % and @ % reduction on the NMB and FMB sides , respectively .


A significant reduction in the Hidradenitis Suppurativa Lesion , Area and Severity Index ( HS-LASI ) after treatment was elicited in both groups , with no pain , erythema or hyperpigmentation .


The combination of MB as a photosensitizer activated with @ nm IPL as a light source is a successful PDT for HS .


Delivery of MB in niosomes was more effective for drug penetration to the dermis compared with delivery by FMB gel .


The @ nm filter was not only a source of activation of MB but also a means of hair-follicle destruction .


The aim of this prospective , randomized study was to compare the clinical results of arthroscopic single-bundle ( SB ) and triple-bundle ( TB ) anterior cruciate ligament ( ACL ) reconstruction .


The study included @ patients who underwent arthroscopic SB ACL and TB ACL reconstruction .


Anterior stress radiographs and the maximal manual muscle test using a KT-@ arthrometer were used to assess anteroposterior stability and rotational stability was investigated using the lateral pivot shift test at the @th month follow-up .


Clinical results were assessed using the International Knee Documentation Committee ( IKDC ) and Orthopdische Arbeitsgruppe Knie ( OAK ) scores preoperatively and at the @th month follow-up .


Postoperative thigh circumference , strength and range of motion ( ROM ) were compared between groups .


Rotational stability was significantly superior in the TB group than in the SB group .


There were no statistically significant differences with regard to residual anteroposterior laxity determined at the @th month follow-up .


No significant difference in terms of IKDC score , OAK score , thigh circumference , strength and ROM was detected between the two groups .


Both arthroscopic SB and TB ACL reconstruction resulted in satisfactory subjective outcome and objective stability .


Rotational stability was significantly superior in the TB group .


To assess the effect on mode of delivery of the routine use of labour epidural analgesia ( EA ) compared with analgesia on request .


Randomised non-inferiority trial .


One university and one non-university teaching hospital in The Netherlands .


Women with a singleton pregnancy in cephalic presentation beyond @ + @ weeks ' gestation .


Participants were randomly allocated to receive either routine EA or analgesia on request .


Intention-to-treat ( ITT ) and per-protocol ( PP ) analyses were performed , with confidence intervals ( CI ) calculated for the differences in percentages or means .


Rate of operative delivery ( instrumental vaginal or caesarean ) , labour characteristics , and adverse labour and neonatal outcomes .


A total of @ women were randomly allocated to the routine EA ( n = @ ) or analgesia on request group ( n = @ ) .


In the routine EA group , @ % ( @/@ ) received EA .


According to ITT analysis , @ % ( @/@ ) women in the routine EA group had an operative delivery , compared with @ % ( @/@ ) in the analgesia on request group ( difference @ % , @ % CI -@ to @ ) .


The difference in rate of operative deliveries according to the PP analysis was statistically significant ( difference @ % , @ % CI @ to @ ) .


Inferiority of EA could not be rejected , as in both analyses the upper bound of the confidence interval exceeded the pre-specified inferiority criterion of +@ % .


Women in the routine EA group had more adverse effects , including hypotension ( difference @ % , @ % CI @ to @ ) , and motor blockade ( difference @ % , @ % CI @ to @ ) .


Non-inferiority of routine EA could not be demonstrated in this trial .


Routine EA use is likely to lead to more operative deliveries and more maternal adverse effects .


The results of our study do not justify routine use of EA .


We investigated the prevalence of various parental pro-drinking practices and its association with parental drinking status .


A school-based survey was completed by @ students ( mean age @ , SD @ ; boys @ % ) from @ randomly selected secondary schools in Hong Kong .


Students reported whether they had ever experienced each of nine parental pro-drinking practices ( PPDPs ) .


Overall , @ % of students reported at least one PPDP , but the prevalence was much higher if both parents were drinkers ( @ % ) compared with non-drinkers ( @ % ) .


The adjusted odds ratio ( AOR ) ( @ % CI ) of experiencing at least one PPDP was @ ( @ , @ ) if either parent drank and @ ( @ , @ ) if both drank compared with none ( P for trend < @ ) .


Compared with non-drinking , the AORs ( @ % CI ) of experiencing at least one PPDP for occasional drinking and frequent drinking were @ ( @ , @ ) and @ ( @ , @ ) in fathers ( P for trend < @ ) , and @ ( @ , @ ) and @ ( @ , @ ) in mothers .


The prevalence of PPDPs was generally low in non-drinking parents , but increased dramatically with the number of drinking parents and the frequency of paternal drinking .


Transcranial magnetic stimulation ( TMS ) is a safe and effective treatment for major depression .


We describe quality of life ( QOL ) outcomes from acute treatment with TMS , and describe the durability of benefit across @-weeks .


Three hundred and one medication-free patients with pharmacoresistant major depression were randomized to active or sham TMS in a @-week controlled trial .


Nonresponders to the @-week blinded phase of the study were enrolled in a @-week open-label study without unblinding the prior treatment assignment .


Responders and partial responders to both the blinded ( active or sham treatment ) or open acute treatment phases were tapered off TMS over three weeks , while initiating maintenance antidepressant medication monotherapy .


These subjects entered the @-week study to examine the durability of response to TMS .


The Medical Outcomes Study-@ Item Short Form ( SF-@ ) and the Quality of Life Enjoyment and Satisfaction Questionnaire ( Q-LES-Q ) were used to measure overall function and QOL .


During the @-week durability of effect study , QOL assessments were done at study entry and at the end of @-weeks .


Statistically significant improvement in both functional status and QOL outcomes was observed in patients treated with active TMS compared with sham TMS during the acute phase of the randomized , sham-controlled trial .


Similar benefits were observed in patients who entered the open-label extension study .


These improvements were sustained across the @-week follow up study .


Acute treatment with TMS improved functional status and QOL outcomes in patients with major depression .


This clinical effect was durable in long-term follow up .


Current guidelines recommend combining long-acting bronchodilators with different modes of action in patients with moderate-to-severe chronic obstructive pulmonary disease ( COPD ) .


We evaluated the effects of airway dimensions and pulmonary function with tiotropium plus indacaterol versus Advair ( ) .


Subjects ( n = @ ) were randomized to receive tiotropium ( @g once daily ) plus indacaterol ( @g once daily ) or Advair ( ) ( @/@g twice daily ) for @ weeks .


Airway geometry was determined by quantitative computed tomography ( luminal area , Ai ; total area of the airway , Ao ; wall area , WA ; and percentage wall area , WA/Ao and wall thickness , T ) .


Spirometry ( forced expiratory volume in @s , FEV@ ; forced vital capacity , FVC and inspiratory capacity , IC ) and St. George 's Respiratory Questionnaire ( SGRQ ) were evaluated .


Tiotropium plus indacaterol significantly increased CT-indices including Ai corrected for body surface area ( Ai/BSA ) , and decreased WA/BSA , WA/Ao and T/BSA compared with Advair ( ) ( p < @ , respectively ) .


In physiological parameters , mean difference in IC was significantly higher under treatment with tiotropium plus indacaterol than Advair ( ) ( p < @ ) .


The changes in Ai/BSA , WA/BSA , WA/Ao and T/BSA were significantly correlated with changes in IC ( r = @ , p = @ ; r = -@ , p < @ ; r = -@ , p = @ and r = -@ , p = @ ; respectively ) .


There were more significant improvements in SGRQ scores after treatment with tiotropium plus indacaterol than Advair ( ) .


These findings suggest that dual bronchodilation with tiotropium plus indacaterol is superior in airway geometry and lung function compared with Advair ( ) in COPD .


Little is known about the long-term effect of a chef-enhanced menu on healthier food selection and consumption in school lunchrooms .


In addition , it remains unclear if extended exposure to other strategies to promote healthier foods ( eg , choice architecture ) also improves food selection or consumption .


To evaluate the short - and long-term effects of chef-enhanced meals and extended exposure to choice architecture on healthier school food selection and consumption .


A school-based randomized clinical trial was conducted during the @-@ school year among @ elementary and middle schools in @ urban , low-income school districts ( intent-to-treat analysis ) .


Included in the study were @ students in grades @ through @ attending participating schools ( @ % of eligible participants ) .


Schools were first randomized to receive a professional chef to improve school meal palatability ( chef schools ) or to a delayed intervention ( control group ) .


To assess the effect of choice architecture ( smart caf ) , all schools after @ months were then randomized to the smart caf intervention or to the control group .


School food selection was recorded , and consumption was measured using plate waste methods .


After @ months , vegetable selection increased in chef vs control schools ( odds ratio -LSB- OR -RSB- , @ ; @ % CI , @-@ @ ) , but there was no effect on the selection of other components or on meal consumption .


After long-term or extended exposure to the chef or smart caf intervention , fruit selection increased in the chef ( OR , @ ; @ % CI , @-@ @ ) , smart caf ( OR , @ ; @ % CI , @-@ @ ) , and chef plus smart caf ( OR , @ ; @ % CI , @-@ @ ) schools compared with the control schools , and consumption increased in the chef schools ( OR , @ ; @ % CI , @-@ @ cups/d ) .


Vegetable selection increased in the chef ( OR , @ ; @ % CI , @-@ @ ) , smart caf ( OR , @ ; @ % CI , @-@ @ ) , and chef plus smart caf schools ( OR , @ , @ % CI , @-@ @ ) compared with the control schools , and consumption also increased in the chef ( OR , @ ; @ % CI , @-@ @ cups/d ) and chef plus smart caf ( OR , @ ; @ % CI , @-@ @ cups/d ) schools ; however , the smart caf intervention alone had no effect on consumption .


Schools should consider both collaborating with chefs and using choice architecture to increase fruit and vegetable selection .


Efforts to improve the taste of school foods through chef-enhanced meals should remain a priority because this was the only method that also increased consumption .


This was observed only after students were repeatedly exposed to the new foods for @ months .


Therefore , schools should not abandon healthier options if they are initially met with resistance .


The aim of the study was to evaluate the impact of magnesium ( Mg ) on the evolution of arterial calcifications in hemodialysis patients .


Seventy-two stable hemodialysis patients were randomly allocated to two groups : @ administered a regimen containing magnesium carbonate plus calcium acetate as a phosphate binder ( Mg group ) , while the rest @ received calcium acetate alone ( Ca group ) .


The presence and the progression of arterial calcifications were evaluated in plain X-rays using a simple vascular calcification score .


The duration of the follow-up period was @ months .


Thirty-two patients of the Mg group and @ of the Ca group completed the study .


The mean time average values of the biochemical laboratories did not differ between the two groups , except serum Mg : @ + @ in the Mg group versus @ + @ mg/dl in the Ca group , p = @ .


In @/@ ( @ % ) patients of the Mg group and in @/@ ( @ % ) patients of the Ca group , the arterial calcifications were worsened , p = @ .


Moreover , in @/@ ( @ % ) patients of the Mg group and in @/@ ( @ % ) patients of the Ca group , they were improved , p = @ .


The multivariate logistic regression analysis revealed that serum magnesium was an independent predictor for no progression of the arterial calcifications , p = @ .


Magnesium probably retards the arterial calcifications in hemodialysis patients .


Further clinical studies are needed to clarify whether magnesium provides cardiovascular protection to this group of patients .


The aim of this study was to compare the clinical and aesthetic outcomes of two different surgical approaches for the treatment of deep gingival recession affecting the mandibular incisors .


Fifty patients with Miller class I and II gingival recessions ( @ mm ) in the lower incisors were enrolled .


Twenty-five patients were randomly assigned to the control group and the other @ patients to the test group .


All defects were treated with the coronally advanced flap + connective tissue graft ( CAF + CTG ) and in the test group the labial submucosal tissue ( LST ) was removed .


Post-operative morbidity was evaluated at @ week .


Clinical and aesthetic evaluations were made at @ year .


Statistically greater recession reduction , probability of CRC ( adjusted OR @ @ % CI = @-@ @ , p = @ ) and greater increase in GT were observed in the test group .


Greater graft exposure and increase in KTH were demonstrated in the control group .


Better aesthetics outcomes were observed in the test group .


No statistically significant between groups differences were demonstrated in patient analgesic assumption and post-operative discomfort and bleeding .


LST removal during CAF + CTG surgery is indicated to provide better root coverage and aesthetic outcomes in the treatment of gingival recessions affecting the lower incisors .


The aim of this study was to compare the efficacy and safety of lercanidipine and amlodipine in the treatment of hypertensive patients with acute cerebral ischemic stroke .


An open label , controlled , randomized , parallel-group study was conducted on @ hypertensive patients ( blood pressure -LSB- BP -RSB- > @/@mmHg ) diagnosed with ischemic stroke .


Enrolled subjects were randomly assigned to a @ week treatment with lercanidipine @mg/day or amlodipine @mg/day .


The treatment was administered during the acute phase of the stroke , either immediately after the diagnosis or during an observation period of maximum @ days .


Both lercanidipine and amlodipine were able to significantly reduce mean clinical systolic BP ( SBP ) / diastolic BP ( DBP ) , mean @h ambulatory BP and day-time and night-time BP .


In particular , mean clinical SBP/DBP was reduced from @ / @ mmHg to @ / @ mmHg in the lercanidipine group ( p < @ for SBP and p < @ for DBP ) and from @ / @ mmHg to @ / @ mmHg in the amlodipine-treated group ( p < @ for both SBP and DBP ) .


No statistical difference was observed between the two treatments in the reduction of clinical BP .


The response and normalization rates registered in the two groups of patients were also similar , with no significant difference between the two drugs .


In addition , both treatments reported comparable results in terms of early morning BP surge reduction and BP stabilization , measured through trough-peak ratio and smoothness index .


However lercanidipine showed a better tolerability profile than amlodipine , with fewer adverse events and a lower percentage of patients suffering from side effects .


Lercanidipine is as effective as amlodipine in the reduction and stabilization of BP in hypertensive patients after a stroke , and presents some advantages in terms of safety .


Larger studies are necessary to further evaluate these preliminary findings .


This study was intended to explore the relationship between the genetic polymorphisms of the @ single nucleotide polymorphisms ( SNPs ) at CYP genes , neuroendocrine factors and the response to selective serotonin reuptake inhibitors ( SSRIs ) in Chinese Han depressive patients .


This was a @-week randomized controlled trial consisting of @ Chinese Han depressive patients treated with SSRIs .


@ SNPs of CYP@ genes and @ neuroendocrine factors were detected .


Allele and genotype frequencies were compared between responders and non-responders .


The relationships between neuroendocrine factors and treatment response were also analyzed .


No significant differences were found in clinical features between @ groups at the baseline .


No statistical correlation was found between either the genotype or allele frequencies of SNPs in CYP@A@ , CYP@C@ , or CYP@D@ gene and the - efficacy of SSRIs .


There were strong linkage disequilibria between rs@ , rs@ , and rs@ of CYP@C@ genes , and rs@ , rs@ of CYP@A@ genes .


No associations were found between the above haplotypes and the antidepressant response .


No neuroendocrine factor was a significant predictor for a response to SSRI antidepressants independently .


The combination of neuroendocrine factors , however , predicted the response by @ % .


There were no significant associations between the @ SNPs of CYP gene polymorphisms and SSRI response .


Neither cytochrome P@ family genes nor neuroendocrine factors independently predict the patients ' response to the antidepressants separately .


A combination of neuroendocrine factors , however , does have the potential to predict the response .