Participants were included in the analysis if they reported suicidal ideation on the HRSD or BDI ( score of @ ) .


Multivariate linear regression indicated that both IPT ( b = @ , p < @ ) and medication ( b = @ , p < @ ) yielded a significant reduction in suicide symptoms compared to placebo on the HRSD .


Multivariate linear regression indicated that after adjustment for change in depression these treatment effects were no longer significant .


Moderate Cohens d effect sizes from baseline to post-test differences in suicide score by treatment group are reported .


These analyses were completed on a single suicide item from each of the measures .


Moreover , the TDCRP excluded participants with moderate to severe suicidal ideation .


This study demonstrates the specific effectiveness of IPT and medications in reducing suicidal ideation ( relative to placebo ) , albeit largely as a consequence of their more general effects on depression .


This adds to the growing body of evidence that depression treatments , specifically IPT and medication , can also reduce suicidal ideation and serves to further our understanding of the complex relationship between depression and suicide .


We aimed to study the relationship between measures of adiposity , insulin sensitivity and N-terminal pro-B-type natriuretic peptide ( NT-proBNP ) in the Diabetes Prevention Program ( DPP ) .


The DPP is a completed clinical trial .


Using stored samples from this resource , we measured BMI , waist circumference ( WC ) , an insulin sensitivity index ( ISI ; -LSB- @/HOMA-IR -RSB- ) and NT-proBNP at baseline and at @ years of follow-up in participants randomised to placebo ( n = @ ) , intensive lifestyle intervention ( n = @ ) or metformin ( n = @ ) .


At baseline , log NT-proBNP did not differ between treatment arms and was correlated with baseline log ISI ( p < @ ) and WC ( p = @ ) but not with BMI ( p = @ ) .


After @ years of treatment , BMI decreased in the lifestyle and metformin groups ( both p < @ ) ; WC decreased in all three groups ( p < @ for all ) ; and log ISI increased in the lifestyle and metformin groups ( both p < @ ) .


The change in log NT-proBNP did not differ in the lifestyle or metformin group vs the placebo group ( p > @ for both ) .


In regression models , the change in log NT-proBNP was positively associated with the change in log ISI ( p < @ ) in all three study groups after adjusting for changes in BMI and WC , but was not associated with the change in BMI or WC after adjusting for changes in log ISI .


Circulating NT-proBNP was associated with a measure of insulin sensitivity before and during preventive interventions for type @ diabetes in the DPP .


This relationship persisted after adjustment for measures of adiposity and was consistent regardless of whether a participant was treated with placebo , intensive lifestyle intervention or metformin .


The aim of this study is to examine the feasibility , efficacy , and safety of a group-based yoga therapy intervention for middle-aged and older women with urinary incontinence .


We conducted a pilot randomized trial of ambulatory women aged @ years and older with stress , urgency , or mixed-type incontinence .


Women were randomized to a @-week yoga therapy program ( n = @ ) consisting of twice weekly group classes and once weekly home practice or a wait-list control group ( n = @ ) .


All participants also received written pamphlets about standard behavioral self-management strategies for incontinence .


Changes in incontinence were assessed with @-day voiding diaries .


The mean ( SD ) age was @ ( @ ) years , and the mean baseline frequency of incontinence was @ ( @ ) episodes/d .


After @ weeks , the total incontinence frequency decreased by @ % ( @ -LSB- @ -RSB- fewer episodes/d ) in the yoga therapy versus @ % ( @ -LSB- @ -RSB- fewer episodes/d ) in the control group ( P = @ ) .


Participants in the yoga therapy group also reported an average of @ % decrease in stress incontinence frequency ( @ -LSB- @ -RSB- fewer episodes/d ) compared with a @ % increase in controls ( @ -LSB- @ -RSB- more episodes/d ) ( P = @ ) .


No significant differences in reduction in urgency incontinence were detected between the yoga therapy versus control groups ( @ -LSB- @ -RSB- versus @ -LSB- @ -RSB- fewer episodes/d ; P = @ ) .


All women starting the yoga therapy program completed at least @ % of the group classes and practice sessions .


Two participants in each group reported adverse events unrelated to the intervention .


Findings provide preliminary evidence to support the feasibility , efficacy , and safety of a group-based yoga therapy intervention to improve urinary incontinence in women .


The role of genetics for predicting the response to cognitive behavior therapy ( CBT ) for social anxiety disorder ( SAD ) has only been studied in one previous investigation .


The serotonin transporter ( @-HTTLPR ) , the catechol-o-methyltransferase ( COMT ) val@met , and the tryptophan hydroxylase-@ ( TPH@ ) G-@T polymorphisms are implicated in the regulation of amygdala reactivity and fear extinction and therefore might be of relevance for CBT outcome .


The aim of the present study was to investigate if these three gene variants predicted response to CBT in a large sample of SAD patients .


Participants were recruited from two separate randomized controlled CBT trials ( trial @ : n = @ , trial @ : n = @ ) .


Genotyping were performed on DNA extracted from blood or saliva samples .


Effects were analyzed at follow-up ( @ or @ months after treatment ) for both groups and for each group separately at post-treatment .


The main outcome measure was the Liebowitz Social Anxiety Scale Self-Report .


At long-term follow-up , there was no effect of any genotype , or gene gene interactions , on treatment response .


In the subsamples , there was time by genotype interaction effects indicating an influence of the TPH@ G-@T-polymorphism on CBT short-term response , however the direction of the effect was not consistent across trials .


None of the three gene variants , @-HTTLPR , COMTval@met and TPH@ G-@T , was associated with long-term response to CBT for SAD .


Balance control relies on accurate perception of visual , somatosensory and vestibular cues .


Sensory flow is impaired in Multiple Sclerosis ( MS ) and little is known about the ability of the sensory systems to adapt after neurological lesions reducing sensory impairment .


The aims of the present study were to verify whether : @ .


Balance rehabilitation administered in a challenging sensory conditions would improve stability in upright posture .


The improvement in a treated sensory condition would transfer to a non treated sensory condition .


Fifty three persons with MS , median ( min-max ) EDSS score of @ ( @-@ @ ) , participated in a RCT and were randomly assigned to two groups .


The Experimental group received balance rehabilitation aimed at improving motor and sensory strategies .


The Control group received rehabilitation treatment which did not include training of sensory strategies .


Persons with MS were blindly assessed by means of a stabilometric platform with eyes open , eyes closed and dome , on both firm surface and foam .


Anterior-posterior and medio-lateral sway , velocity of sway and the length of Center of Pressure ( CoP ) trajectory were calculated in the six sensory conditions .


Experimental group showed statistically significant improvement ( P < @ ) in stability in upright posture in eyes closed condition on firm surface , and in eyes open , closed , and dome conditions on foam .


No differences were observed between groups in the eyes open condition on firm surface nor in the sensory condition not addressed during the treatment .


After rehabilitation people with MS can recover from sensory impairments thus improving upright balance .


Further , the improvement seems to be context-dependent and present just in the treated sensory conditions .


To assess the effectiveness of a tailored theory-based , Web-delivered intervention ( Young Adults Eating and Active for Health ) developed using community-based participatory research process .


A @-month ( @-week intensive intervention with a @-month follow-up ) randomized , controlled trial delivered via Internet and e-mail .


Thirteen college campuses .


A total of @,@ college students .


Twenty-one mini-educational lessons and e-mail messages ( called nudges ) developed with the non-diet approach and focusing on eating behavior , physical activity , stress management , and healthy weight management .


Nudges were short , frequent , entertaining , and stage-tailored to each behavior , and reinforced lesson content .


All participants were assessed at baseline , postintervention ( @ months from baseline ) , and follow-up ( @ months from baseline ) for primary outcomes of weight , body mass index ( BMI ) , fruit and vegetable intake ( FVI ) , physical activity ( PA ) , and perceived stress ; and secondary outcomes of waist circumference , percent dietary fat , energy from sugar-sweetened beverages , servings of whole grains , self-instruction and regulation for mealtime behavior , hours of sleep , and stage of readiness for change for consuming @ cups of FVI , completing @ minutes of PA/wk , and managing stress on most days of the week .


Demographics were collected at baseline .


Chi-square analysis and mixed-models repeated measures analysis were performed to determine differences between experimental and control outcomes .


There were no differences between experimental and control participants in BMI , weight , and waist circumference .


There were small improvements in FVI ( P = @ ) , vigorous PA in females ( P = @ ) , fat intake ( P = @ ) , self-instruction ( P = @ ) , and regulation ( P = @ ) for mealtime behavior , and hours of sleep ( P = @ ) at postintervention , but improvements were not maintained at follow-up .


At postintervention , a greater proportion of experimental participants were in the action/maintenance stages for FVI ( P = @ ) and PA ( P = @ ) than control .


Young Adults Eating and Active for Health is one of the first studies to use the community-based participatory research process of PRECEDE-PROCEED to develop a non-diet approach intervention .


Although there were no differences between experimental and control participants in weight change or BMI , the intervention supported positive change in behaviors that may mediate excessive weight gain , such as increasing FVI and more healthful self-regulation mealtime behaviors immediately postintervention .


Additional strategies to maintain the behavior changes need to be explored .


Endothelial dysfunction has been suggested as a potential mechanism by which ambient air pollution may cause acute cardiovascular events .


Recently , plasma nitrite has been developed as a marker of endothelial dysfunction .


We examined the changes in plasma nitrite concentration associated with increases in ambient air pollutant concentrations in the previous @ d.


We linked up to three measurements of plasma nitrite concentrations obtained from @ students to @-h average concentrations of five criteria air pollutants -LSB- particle mass < @ m in aerodynamic diameter ( PM ( @ ) ) , carbon monoxide ( CO ) , sulfur dioxide ( SO ) , nitrogen dioxide ( NO ) , and ozone ( O ) -RSB- measured at two monitoring sites closest to Rutgers University campus ( @-@ miles ) in New Jersey during the years @-@ .


We examined the change in plasma nitrite associated with each interquartile-range ( IQR ) increase in pollutant concentration in the previous @h and six preceding @-h periods , using linear mixed models .


IQR increases in mean PM ( @ ) ( @ g/m ) and CO ( @ parts per billion ) concentrations in the first @h before the plasma nitrite measurement were associated with increased plasma nitrite concentrations ( PM ( @ ) : @ nanomolar ; @ % confidence interval ( CI ) : @ , @ ; CO : @ nanomolar ; @ % CI : @ , @ ) .


Increased plasma nitrite associated with IQR increases in O and SO concentrations over longer lags were observed .


Rapid increases in plasma nitrite following exposure to ambient air pollutants support the hypothesis that ambient air pollution is associated with inducible nitric oxide synthase-mediated systemic inflammation in humans .


To compare the effectiveness and acceptability of outpatient polypectomy with inpatient polypectomy .


Pragmatic multicentre randomised controlled non-inferiority study .


Outpatient hysteroscopy clinics in @ UK National Health Service hospitals .


@ women who attended as outpatients for diagnostic hysteroscopy because of abnormal uterine bleeding and were found to have uterine polyps .


Participants were randomly assigned to either outpatient uterine polypectomy under local anaesthetic or inpatient uterine polypectomy under general anaesthesia .


Data were collected on women 's self reported bleeding symptoms at baseline and at @ , @ , and @ months .


Data were also collected on pain and acceptability of the procedure at the time of polypectomy .


The primary outcome was successful treatment , determined by the women 's assessment of bleeding at six months , with a prespecified non-inferiority margin of @ % .


Secondary outcomes included generic ( EQ-@D ) and disease specific ( menorrhagia multi-attribute scale ) quality of life , and feasibility and acceptability of the procedure .


@ % ( @/@ ) of women in the outpatient group and @ % ( @/@ ) in the inpatient group reported successful treatment at six months ( intention to treat relative risk @ , @ % confidence interval @ to @ ; per protocol relative risk @ , @ to @ ) .


Failure to remove polyps was higher ( @ % v @ % ; relative risk @ , @ to @ ) and acceptability of the procedure was lower ( @ % v @ % ; @ , @ to @ ) in the outpatient group Quality of life did not differ significantly between the groups .


Four uterine perforations , one of which necessitated bowel resection , all occurred in the inpatient group .


Outpatient polypectomy was non-inferior to inpatient polypectomy .


Failure to remove a uterine polyp was , however , more likely with outpatient polypectomy and acceptability of the procedure was slightly lower .


Observational studies have raised concerns that high-potency statins increase the risk of acute kidney injury .


We therefore examined the incidence of kidney injury across @ randomized trials of statin therapy .


PROVE IT-TIMI @ enrolled @ subjects after an acute coronary syndrome ( ACS ) and randomized them to atorvastatin @ mg/day versus pravastatin @ mg/day .


A-to-Z enrolled @ subjects after ACS and randomized them to a high-potency ( simvastatin @ mg/day @ months , then simvastatin @ mg/day ) versus a delayed moderate-potency statin strategy ( placebo @ months , then simvastatin @ mg/day ) .


Serum creatinine was assessed centrally at serial time points .


Adverse events ( AEs ) relating to kidney injury were identified through database review .


Across both trials , mean serum creatinine was similar between treatment arms at baseline and throughout follow-up .


In A-to-Z , the incidence of a @-fold or @ mg/dL rise in serum creatinine was @ % for subjects randomized to a high-potency statin regimen versus @ % for those on a delayed moderate-potency regimen ( odds ratio -LSB- OR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


In PROVE IT-TIMI @ , the incidence was @ % for subjects randomized to atorvastatin @ mg/day and @ % for subjects randomized to pravastatin @ mg/day ( OR , @ ; @ % CI , @ to @ ; P = @ ) .


Consistent results were observed for different kidney injury thresholds and in individuals with diabetes mellitus or with moderate renal dysfunction .


The incidence of kidney injury-related adverse events ( AEs ) was not statistically different for patients on a high-potency versus moderate-potency statin regimen ( OR , @ ; @ % CI , @ to @ ; P = @ ) .


For patients enrolled in @ large randomized trials of statin therapy after ACS , the use of a high-potency statin regimen did not increase the risk of kidney injury .


Myeloid-derived suppressor cells ( MDSC ) and regulatory T cells ( Treg ) play a key role in the progression of head and neck squamous cell carcinoma ( HNSCC ) .


On the basis of our preclinical data demonstrating that phosphodiesterase-@ ( PDE@ ) inhibition can modulate these cell populations , we evaluated whether the PDE@ inhibitor tadalafil can revert tumor-induced immunosuppression and promote tumor immunity in patients with HNSCC .


First , we functionally and phenotypically characterized MDSCs in HNSCCs and determined , retrospectively , whether their presence at the tumor site correlates with recurrence .


Then , we performed a prospective single-center , double-blinded , randomized , three-arm study in which patients with HNSCC undergoing definitive surgical resection of oral and oropharyngeal tumors were treated with tadalafil @ mg/day , @ mg/day , or placebo for at least @ days preoperatively .


Blood and tumor MDSC and Treg presence and CD@ ( + ) T-cell reactivity to tumor antigens were evaluated before and after treatment .


MDSCs were characterized in HNSCC and their intratumoral presence significantly correlates with recurrence .


Tadalafil treatment was well tolerated and significantly reduced both MDSCs and Treg concentrations in the blood and in the tumor ( P < @ ) .


In addition , the concentration of blood CD@ ( + ) T cells reactive to autologous tumor antigens significantly increased after treatment ( P < @ ) .


Tadalafil immunomodulatory activity was maximized at an intermediate dose but not at higher doses .


Mechanistic analysis suggests a possible off-target effect on PDE@ at high dosages that , by increasing intracellular cAMP , may negatively affect antitumor immunity .


Tadalafil seems to beneficially modulate the tumor micro - and macro-environment in patients with HNSCC by lowering MDSCs and Tregs and increasing tumor-specific CD@ ( + ) T cells in a dose-dependent fashion .


Tafazzin ( TAZ ) , a transmembrane protein contributes in mitochondrial structural and functional modifications through cardiolipin remodeling .


TAZ mutations are associated with several diseases , but studies on the role of TAZ protein in carcinogenesis and radiotherapy ( RT ) response is lacking .


Therefore we investigated the TAZ expression in rectal cancer , and its correlation with RT , clinicopathological and biological variables in the patients participating in a clinical trial of preoperative RT. .


@ rectal cancer patients were included in this study , of which @ received RT before surgery and the rest underwent surgery alone .


TAZ expression was determined by immunohistochemistry in primary cancer , distant , adjacent normal mucosa and lymph node metastasis .


In-silico protein-protein interaction analysis was performed to study the predictive functional interaction of TAZ with other oncoproteins .


TAZ showed stronger expression in primary cancer and lymph node metastasis compared to distant or adjacent normal mucosa in both non-RT and RT patients .


Strong TAZ expression was significantly higher in stages I-III and non-mucinious cancer of non-RT patients .


In RT patients , strong TAZ expression in biopsy was related to distant recurrence , independent of gender , age , stages and grade ( p = @ , HR , @ , @ % CI , @-@ @ ) .


In silico protein-protein interaction study demonstrated that TAZ was positively related to oncoproteins , Livin , MAC@ and FXYD-@ .


Strong expression of TAZ protein seems to be related to rectal cancer development and RT response , it can be a predictive biomarker of distant recurrence in patients with preoperative RT. .


The potential benefit of dual antiplatelet therapy beyond @ year after a myocardial infarction has not been established .


We investigated the efficacy and safety of ticagrelor , a P@Y@ receptor antagonist with established efficacy after an acute coronary syndrome , in this context .


We randomly assigned , in a double-blind @:@:@ fashion , @,@ patients who had had a myocardial infarction @ to @ years earlier to ticagrelor at a dose of @ mg twice daily , ticagrelor at a dose of @ mg twice daily , or placebo .


All the patients were to receive low-dose aspirin and were followed for a median of @ months .


The primary efficacy end point was the composite of cardiovascular death , myocardial infarction , or stroke .


The primary safety end point was Thrombolysis in Myocardial Infarction ( TIMI ) major bleeding .


The two ticagrelor doses each reduced , as compared with placebo , the rate of the primary efficacy end point , with Kaplan-Meier rates at @ years of @ % in the group that received @ mg of ticagrelor twice daily , @ % in the group that received @ mg of ticagrelor twice daily , and @ % in the placebo group ( hazard ratio for @ mg of ticagrelor vs. placebo , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ; hazard ratio for @ mg of ticagrelor vs. placebo , @ ; @ % CI , @ to @ ; P = @ ) .


Rates of TIMI major bleeding were higher with ticagrelor ( @ % with @ mg and @ % with @ mg ) than with placebo ( @ % ) ( P < @ for each dose vs. placebo ) ; the rates of intracranial hemorrhage or fatal bleeding in the three groups were @ % , @ % , and @ % , respectively .


In patients with a myocardial infarction more than @ year previously , treatment with ticagrelor significantly reduced the risk of cardiovascular death , myocardial infarction , or stroke and increased the risk of major bleeding .


( Funded by AstraZeneca ; PEGASUS-TIMI @ ClinicalTrials.gov number , NCT@ . )


To impact on the obesity epidemic , interventions that prevent weight gain across populations are urgently needed .


However , even the most efficacious interventions will have little impact on obesity prevention unless they are successfully implemented in diverse populations and settings .


Implementation research takes isolated efficacy studies into practice and policy and is particularly important in obesity prevention where there is an urgent need to accelerate the evidence to practice cycle .


Despite the recognised need , few obesity prevention interventions have been implemented in real life settings and to our knowledge rarely target rural communities .


Here we describe the rationale , design and implementation of a Healthy Lifestyle Program for women living in small rural communities ( HeLP-her Rural ) .


The primary goal of HeLP-her Rural is to prevent weight gain using a low intensity , self-management intervention .


Six hundred women from @ small rural communities in Australia will be randomised as clusters ( n-@ control towns and n = @ intervention towns ) .


A pragmatic randomised controlled trial methodology will test efficacy and a comprehensive mixed methods community evaluation and cost analysis will inform effectiveness and implementation of this novel prevention program .


Implementing population interventions to prevent obesity is complex , costly and challenging .


To address these barriers , evidence based interventions need to move beyond isolated efficacy trials and report outcomes related to effectiveness and implementation .


Large pragmatic trials provide an opportunity to inform both effectiveness and implementation leading to potential for greater impact at the population level .


Pragmatic trials should incorporate both effectiveness and implementation outcomes and a multidimensional methodology to inform scale-up to population level .


The learnings from this trial will impact on the design and implementation of population obesity prevention strategies nationally and internationally .


To assess the efficacy of high-frequency ( @ Hz ) brain stimulation on lower limb motor function in subjects with chronic ( > @ mo ) subcortical stroke .


Double-blind , placebo-controlled crossover study .


University hospital .


Right-handed subjects ( N = @ ) affected by a first-ever subcortical stroke in the territory of the middle cerebral artery were included in this study .


Repetitive transcranial magnetic stimulation ( rTMS ) was delivered with the H-coil , specifically designed to target deeper and larger brains regions .


Each subject received both real and sham rTMS in a random sequence .


The @ rTMS cycles ( real or sham ) were composed of @ sessions each , administered over @ weeks and separated by a @-week washout period .


Lower limb functions were assessed by the lower limb Fugl-Meyer scale , the @-m walk test , and the @-minute walk test before and @ day after the end of each treatment period , as well as at a @-week follow-up .


Real rTMS treatment was associated with a significant improvement in lower limb motor function .


This effect persisted over time ( follow-up ) and was significantly greater than that observed with sham stimulation .


A significant increase in walking speed was also found after real rTMS , but this effect did not reach statistical significance in comparison with the sham stimulation .


These data demonstrated that @ weeks of high-frequency deep rTMS could induce long-term improvements in lower limb functions in the chronic poststroke period , lasting at least @ month after the end of the treatment .


Preclinical data suggest combining a mammalian target of rapamycin inhibitor with erlotinib could provide synergistic antitumor effects in advanced non-small-cell lung cancer ( NSCLC ) .


In this multicenter , open-label , phase II study , patients with advanced NSCLC that progressed after one to two previous chemotherapy regimens were randomized @:@ to erlotinib @ mg/dayeverolimus @ mg/day .


Primary end point was the disease control rate ( DCR ) at @ months ; secondary end points included progression-free survival ( PFS ) and safety .


One hundred thirty-three patients received everolimus-erlotinib ( n = @ ) or erlotinib alone ( n = @ ) .


The DCR at @ months was @ % and @ % , respectively .


The probability for the difference in disease control at @ months to be @ % was estimated to be @ % , which was below the prespecified probability threshold of @ % .


Median PFS was @ and @ months , respectively .


Grade @/@ adverse events occurred in @ % and @ % of patients , respectively .


Grade @/@ stomatitis was observed in @ % of combination therapy recipients .


Everolimus @ mg/day plus erlotinib @ mg/day was not considered sufficiently efficacious per the predefined study criteria .


The combination does not warrant further investigation based on increased toxicity and the lack of substantial improvement in disease stabilization .


Some pregnancy complications are characterized by increased levels of cell-free fetal ( cffDNA ) and maternal DNA ( cfmDNA ) , the latter may also be elevated during physical strain .


This study aims at assessing the impact of exercise and metformin intervention in pregnancy , and to compare the levels of cell free DNA in pregnant women with or without PCOS diagnosis .


Consecutive women from two previous randomized controlled trials in pregnancy were included .


Women came from a trial with organized exercise vs. standard antenatal care in pregnancy and a trial of metformin vs. placebo in PCOS women .


Levels of cffDNA , cfmDNA and cell-free total DNA ( cftDNA ) were measured by qPCR .


Training in pregnancy did not affect the levels of cffDNA , cfmDNA or cftDNA .


PCOS-women treated with metformin had lower levels of cfmDNA and cftDNA at week @ ( mean SD : @ @ versus @ @ , p = @ , @ @ versus @ @ , p = @ ) ; otherwise the levels were comparable to PCOS-controls .


Metformin-treated PCOS-women had higher cffDNA at inclusion , in the @st trimester ; later on in pregnancy the levels in the metformin and placebo groups were equal .


A comparison of pregnant women in the exercise study ( TRIP ) to placebo-treated pregnant PCOS-women , showed the levels of cffDNA , cfmDNA or cftDNA during mid-pregnancy ( weeks @-@ ) to be equal .


Training during pregnancy was not associated with altered levels of cffDNA cfmDNA or cftDNA , but metformin treatment may reduce cfmDNA and cftDNA in pregnant PCOS women .


Data concerning the effects of afternoon snacking on ingestive behavior , mood , and cognition are limited .


The purpose of this study was to compare @ kJ of high-protein ( HP ) or high-fat ( HF ) afternoon snacks vs. no snacking on appetite , food intake , mood , and cognition in adolescents .


Thirty-one healthy adolescents ( age : @ @ y ) consumed the following afternoon snacks ( in randomized order ) for @ d : HP snack ( @ g of protein/@ g of fat per @ g of carbohydrates ) , HF snack ( @ g of protein/@ g of fat per @ g of carbohydrates ) , and no snack ( NoS ) .


On day @ of each treatment , the participants completed an @-h testing day containing pre - and postsnack appetite questionnaires , food cue-stimulated functional MRI brain scans , mood , cognitive function , and eating initiation .


Ad libitum dinner and evening snacks were provided and assessed .


HP , but not HF , delayed eating initiation vs. NoS ( P < @ ) .


Both snacks reduced appetite vs. NoS ( P < @ ) with HP eliciting greater reductions than HF ( P < @ ) .


Only HF led to reductions in corticolimbic activation in brain regions controlling food motivation/reward vs. NoS ( P < @ ) .


Although no treatment differences in daily energy intake were detected , HP led to greater protein consumption than NoS ( P < @ ) and greater protein and lower fat consumption than HF ( both , P < @ ) .


HP led to fewer HF/high-sugar evening snacks than NoS ( P < @ ) and HF ( P = @ ) .


Although no treatment effects were detected for mood and cognition , HP tended to reduce confusion-bewilderment ( P = @ ) and increase cognitive flexibility ( P = @ ) , whereas NoS reduced tension-anxiety ( P < @ ) and vigor-activity ( P < @ ) .


Afternoon snacking , particularly on HP soy foods , improves appetite , satiety , and diet quality in adolescents , while beneficially influencing aspects of mood and cognition .


This trial was registered at clinicaltrials.gov as NCT@ .


Phlebotropic activity , protective effect on the capillaries and anti-inflammatory properties of the Flavonoids have been reported in literature .


Recently , we evaluated the effect of these drugs in controlling postoperative symptoms of proctologic surgery .


In this randomized study we compared the results obtained in two groups of patients , with grade II haemorrhoids , submitted to radiofrequency coagulation of the hemorrhoidal nodule with radiofrequency scalpel ( CHR ) , to verify the effects of Flavonoids to reduce further symptoms after treatment .


Out of @ patients initially randomized , a total of @ patients regularly returned to outpatient visit at least for @ month of follow-up .


Consequently , two groups of patients were considered : Group A , represented by @ individuals treated with Flavonoids , and Group B , consisting of @ patients as a control group .


Our purpose was to determine : grade of pain after procedure and at first evacuation ( score from @ to @ ) , bleeding , incidence of failures and complications , patient 's satisfaction after @ days from the treatment ( score from @ to @ ) .


We observed that the results obtained regarding the pain reported at the end of procedures ( @ @ for group A and @ @ for group B ) and at the first evacuation ( @ @ for group A and @ @ for group B ) are similar in both study groups .


Instead , the mean score on overall satisfaction at @ days from the treatment showed a statistical significance ( @ @ for group A and @ @ for group B ; p < @ ) .


There were no reported other important issues .


Our results confirm the usefulness of Flavonoids to make more comfortable the post-treatment period .


To investigate the clinical performance of a silorane-based composite resin used for repairing dimethacrylate - based composite restorations .


One operator repaired defective dimethacrylate-based resin restorations that were randomly assigned to one of two treatment groups : control ( n = @ ) , repaired with Adper SE Plus and Filtek P@ Posterior Restorative ( @M ESPE ) ; or test ( n = @ ) , repaired with P@ System Adhesive Self-Etch Primer and Bond and Filtek P@ Low Shrink Posterior Restorative ( @M ESPE ) .


After @ week , restorations were finished and polished .


Two calibrated examiners ( weighted Kappa@ @ ) evaluated the repaired restorations , blindly and independently , at baseline , after @ months , @ and @ years .


The parameters examined were marginal adaptation , anatomic form , surface roughness , marginal discoloration , postoperative sensitivity , and secondary caries .


The restorations were classified as Alfa , Bravo , or Charlie , according to modified US Public Health Service criteria .


Variation in the levels of clinical parameters over time was evaluated by Friedman 's ANOVA ( = @ ) .


The Mann-Whitney test assessed the differences between the materials for all clinical criteria at baseline , @-month , @ - and @-year recalls ( = @ ) .


The Wilcoxon test compared each composite resin for all clinical criteria at the same recalls ( = @ ) .


After two years , @ repaired restorations were re-examined .


No statistically significant differences were found between the materials at baseline or at the @-year recall ( p > @ ) .


Comparing baseline and @-year recall , there was a statistically significant difference for marginal discoloration ( p = @ ) in silorane-based composite restorations .


After two years , the clinical performance of the silorane-based composite was similar to that of the dimethacrylate-based composite when used to make repairs .


Neuropsychological and neurological deficits are still major causes of mortality and morbidity after cardiac surgery .


These complications are thought to be caused by embolisms and cerebral hypoxia .


Thus , continuous neuromonitoring is essential during cardiac surgery due to cerebral oxygen desaturation during different periods .


Near-infrared spectrophotometry ( NIRS ) , anon-invasive method , appears to offer many advantages for monitoring cerebral oxygenation and hemodynamics .


Desaturation of cerebral oxygen may occur at the beginning of cardiopulmonary bypass ( CPB ) or during the low perfusion and rewarming stages if not corrected .


This study was designed to assess the effects of sevoflurane on cerebral protection during CPB .


Eighty patients were divided into two groups .


Anesthesia was maintained either with fentanyl and midazolam ( total intravenous anesthesia , TIVA ) or with one minimum alveolar concentration of sevoflurane and fentanyl .


Cerebral desaturation was defined as an absolute decrease in saturation of @ % from baseline cerebral saturation .


When desaturation occurred , PaCO@ , hematocrit and PaO@ levels were checked and corrected .


If desaturation continued , anesthetic depth was increased to reserve saturation with @-@mg of propofol .


NIRS values and hemodynamics were recorded at predetermined time intervals .


Cerebral oxygen saturation values on the right side were higher in the sevoflurane group than in the TIVA group .


The values on the left side were higher in the sevoflurane group than in the TIVA group , and meaningful differences were seen at the lowest temperature and at @C .


Oxygen saturation was higher in the sevoflurane group than in the TIVA group .


Thus , the effect of sevoflurane was useful for maintaining cerebral oxygen saturation during CBP .


Moderate alcohol consumption has been associated with a reduced risk of mortality and coronary artery disease .


The relationship between cardiovascular health and alcohol use in type @ diabetes is less clear .


The current study assesses the effects of alcohol use among participants in the Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified-Release Controlled Evaluation ( ADVANCE ) trial .


The effects of alcohol use were explored using Cox regression models , adjusted for potential confounders .


The study end points were cardiovascular events ( cardiovascular death , myocardial infarction , and stroke ) , microvascular complications ( new or worsening nephropathy or retinopathy ) , and all-cause mortality .


During a median of @ years of follow-up , @,@ ( @ % ) patients died , @,@ ( @ % ) experienced a cardiovascular event , and @,@ ( @ % ) experienced a microvascular complication .


Compared with patients who reported no alcohol consumption , those who reported moderate consumption had fewer cardiovascular events ( adjusted hazard ratio -LSB- aHR -RSB- @ ; @ % CI @-@ @ ; P = @ ) , less microvascular complications ( aHR @ ; @ % CI @-@ @ ; P = @ ) , and lower all-cause mortality ( aHR @ ; @ % CI @-@ @ ; P = @ ) .


The benefits were particularly evident in participants who drank predominantly wine ( cardiovascular events aHR @ , @ % CI @-@ @ , P = @ ; all-cause mortality aHR @ , @ % CI @-@ @ , P = @ ) .


Compared with patients who reported no alcohol consumption , those who reported heavy consumption had dose-dependent higher risks of cardiovascular events and all-cause mortality .


In patients with type @ diabetes , moderate alcohol use , particularly wine consumption , is associated with reduced risks of cardiovascular events and all-cause mortality .


Split-thickness skin graft ( STSG ) donor sites sometimes cause more postoperative morbidity for patients than the wound covered with the graft .


Yet , there is no consensus on which dressings are best suited to treat these donor sites .


To evaluate two commonly used modern wound dressings in the postoperative healing of STSG donor sites in a prospective randomized controlled trial .


@ patients were randomly assigned to treatment of an STSG donor site with an alginate dressing or a polyurethane film dressing .


The primary outcome measures were postoperative pain scores , secondary outcome variables were time to epithelialization , dressing changes and complications .


Postoperative pain on day @ was significantly lower in the polyurethane film group ( @ vs. @ , p = @ ) as compared to the alginate group .


This difference was not detected on day @ ( @ vs. @ , p = @ ) .


Time to epithelialization did not differ significantly between the two dressing groups .


There were more dressing changes in the polyurethane film group and problems with leakage .


Whereas film dressings resulted in initially lower pain scores , alginate dressings caused fewer additional dressing changes and less leakage .


Multiple techniques and implants are available for all-inside meniscal repair , but the knowledge about their failure rates and functional outcome is still incomplete .


The hypothesis was that there might be differences between meniscal arrows and suture devices regarding reoperation rates and functional outcome .


Thereby , the aim of this study was to compare clinical results following repair with the Biofix ( ) arrows or the FasT-Fix ( ) suture devices .


In this RCT , @ patients were treated either by Biofix ( ) ( n = @ ) or FasT-Fix ( ) ( n = @ ) .


The main outcome was reoperation within @ years .


Knee function and activity level were evaluated by KOOS and Tegner activity scale .


Twelve out of @ ( @ % ) patients were reoperated within @ years , nine out of @ ( @ % ) in the Biofix ( ) - group versus three out of @ ( @ % ) in the FasT-Fix ( ) - group ( p = @ ) .


The relative risk of reoperation was @ times higher for Biofix ( ) compared to FasT-Fix ( ) ( @ % confidence interval @-@ @ ) .


Both treatment groups had significant increase in all KOOS subscales , but there were no major differences between the groups .


The subgroup of reoperated patients differed from the other patients with higher Tegner score preoperatively ( median @ vs. @ ) ( p = @ ) and at @-month follow-up ( median @ vs. @ ) ( p = @ ) .


These results indicate that FasT-Fix ( ) suture is superior to Biofix ( ) arrows with significant lower failure rate .


Functional outcome did not depend on repair technique .


Higher activity score preoperatively and at @-month follow-up in the reoperated patients indicates that activity level may influence on the risk of reoperation .


Antidepressant medication ( ADM ) is thought to reduce depressive symptoms by altering emotion-generative brain systems .


However , it is unknown whether successful ADM treatment is associated with changes in psychobehavioral strategies used to regulate emotions .


We examined depressive symptoms and emotion regulation strategies before and after ADM in the international Study to Predict Optimized Treatment in Depression ( iSPOT-D ) .


The study enrolled @ adult patients with MDD ( @-@ years old ) from @ primary and psychiatric care sites worldwide .


Patients were randomly assigned to an @-week course of escitalopram , sertraline , or venlafaxine-extended-release .


We examined whether ADM is associated with changes in suppression , usually associated with maladaptive outcomes , and reappraisal , usually associated with adaptive outcomes .


We also tested whether changes in emotion regulation predict changes in depressive symptoms following ADM.


We observed more adaptive emotion regulation ( decreased use of suppression and increased use of reappraisal ) following ADM. Furthermore , the largest improvements in emotion regulation were associated with the best treatment outcomes .


Because we assessed acute outcomes , it is not yet known if the effects of ADM on emotion regulation would persist over time .


ADMs are associated with acute , adaptive changes in the psychobehavioral strategies used to regulate emotions .


Interpretation of double-blind placebo-controlled food challenges ( DBPCFC ) can be difficult , particularly with ambiguous subjective symptoms .


Early opening of the challenge key ( which day is verum and which placebo ) may influence the clinician 's interpretation of the DBPCFC result .


Fifty-one clinicians reviewing results of @ DBPCFCs with ambiguous clinical symptoms were randomized into a key first strategy ( opening the DBPCFC key before reviewing the symptoms on both challenge days and deciding on the DBPCFC result ) or a symptoms first strategy ( reviewing symptoms and interpreting both test days as positive or negative before opening the key and deciding on the DBPCFC result ) .


The proportion of DBPCFCs considered inconclusive was comparable between the two strategy groups ( p = @ ) .


Participants in the symptoms first group were more likely to consider a DBPCFC as positive ( in @ tests , @ % ) than subjects in the key first group ( four tests , @ % ) .


The number of positive tests was higher in the symptoms first group ( median @ % , interquartile range -LSB- IQR -RSB- @-@ @ % ) than in the key first groups ( @ % , IQR @-@ @ % , p = @ ) .


This was independent of the participant 's profession ( pediatrician or other ) , age , gender , or years of experience ( p > @ ) .


Clinicians differ in their interpretation of DBPCFC results when symptoms are ambiguous .


Opening the key of a DBPCFC before reviewing and interpreting symptoms significantly reduces the likelihood of the challenge being interpreted as positive .


Guidelines for performing DBPCFCs should standardize the moment of opening the challenge key .


The bivalent fear of evaluation ( BFOE ) model suggests that fears of negative evaluation ( FNE ) and positive evaluation ( FPE ) are distinct features in social anxiety disorder as well as in non-clinical variations of social anxiety .


The constructs can be measured utilizing the Brief Fear of Negative Evaluation Scale Revised ( BFNE-R ) and the Fear of Positive Evaluation Scale ( FPES ) , respectively .


Whereas the distinction between FNE and FPE has been well examined in survey studies , concomitant evidence from laboratory tasks is scarce .


The present study tested whether subjective unpleasantness responses to short films simulating positive and negative evaluation from others are related to individual differences in FNE and FPE .


Ninety-eight unselected individuals watched @ short films displaying actors expressing positive , negative and neutral sentences and rated their responses on unpleasantness .


Furthermore , pride responses to positive films were examined since these can be expected to discriminate between FPE and FNE .


As expected , higher BFNE-R scores were related to more unpleasant responding to negative films , whereas higher FPES scores were related to more unpleasant responding to positive films .


Furthermore , experience of pride following positive films correlated positively with BFNE-R , but negatively with FPES scores .


Participants were university students which limits representativeness .


The study revealed that measures of FNE and FPE show distinct relationships with positive and negative social feedback which provides further evidence for the BFOE model in a laboratory setting .


The optimal duration of anticoagulation after a first episode of unprovoked pulmonary embolism is uncertain .


To determine the benefits and harms of an additional @-month treatment with warfarin vs placebo , after an initial @-month nonrandomized treatment period on a vitamin K antagonist .


Randomized , double-blind trial ( treatment period , @ months ; median follow-up , @ months ) ; @ adult patients who had experienced a first episode of symptomatic unprovoked pulmonary embolism ( ie , with no major risk factor for thrombosis ) and had been treated initially for @ uninterrupted months with a vitamin K antagonist were randomized and followed up between July @ and September @ in @ French centers .


Warfarin or placebo for @ months .


The primary outcome was the composite of recurrent venous thromboembolism or major bleeding at @ months after randomization .


Secondary outcomes were the composite at @ months ( treatment period plus @-month follow-up ) , as well as each component of the composite , and death unrelated to pulmonary embolism or major bleeding , at @ and @ months .


After randomization , @ patients were lost to follow-up , all after month @ , and @ withdrew due to an adverse event .


During the @-month treatment period , the primary outcome occurred in @ of @ patients ( @ % ) in the warfarin group and in @ of @ ( @ % ) in the placebo group ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @-@ @ ; P = @ ) .


Recurrent venous thromboembolism occurred in @ patients in the warfarin group and @ patients in the placebo group ( HR , @ ; @ % CI , @-@ @ ) ; major bleeding occurred in @ patients in the warfarin group and in @ patient in the placebo group ( HR , @ ; @ % CI , @ to @ ) .


During the @-month entire study period ( including the study treatment and follow-up periods ) , the composite outcome occurred in @ patients ( @ % ) in the warfarin group and in @ ( @ % ) in the placebo group ( HR , @ ; @ % CI , @-@ @ ) .


Rates of recurrent venous thromboembolism , major bleeding , and unrelated death did not differ between groups .


Among patients with a first episode of unprovoked pulmonary embolism who received @ months of anticoagulant treatment , an additional @ months of treatment with warfarin reduced the composite outcome of recurrent venous thrombosis and major bleeding compared with placebo .


However , benefit was not maintained after discontinuation of anticoagulation therapy .


Use of antibiotics in critically ill patients may increase the risk of invasive Candida infection .


The objective of this study was to determine whether increased exposure to antibiotics is associated with increased prevalence of invasive Candida infection .


Substudy using data from a randomized controlled trial , the Procalcitonin And Survival Study @-@ .


Nine multidisciplinary ICUs across Denmark .


A total of @,@ critically ill patients .


Patients were randomly allocated to either a `` high exposure '' antibiotic therapy ( intervention arm , n = @ ) or a `` standard exposure '' guided by current guidelines ( n = @ ) .


Seventy-four patients met the endpoint , `` invasive Candida infection , '' @ in the high exposure arm and @ in standard exposure arm ( relative risk = @ ; @ % CI , @-@ @ ; p = @ ) .


Among medical patients in the high exposure arm , the use of ciprofloxacin and piperacillin/tazobactam was @ % and @ % higher than in the standard exposure arm ; no difference in antibiotic exposure was observed between the randomized arms in surgical patients .


Among medical intensive care patients , invasive Candida infection was more frequent in the high exposure arm ( @ % ; @/@ ) than in standard exposure arm ( @ % ; @/@ ) ( hazard ratio = @ ; @ % CI , @-@ @ ; p = @ ) .


Ciprofloxacin used at study entry independently predicted invasive Candida infection ( adjusted hazard ratio = @ -LSB- @-@ @ -RSB- ) ; the risk gradually increased with duration of ciprofloxacin therapy : six of @ in patients not exposed ( @ % ) , eight of @ ( @ % ) when used for @-@ days ( hazard ratio = @ ; @ % CI , @-@ @ ) , and @ of @ ( @ % ) when used for @ days ( hazard ratio = @ ; @ % CI , @-@ @ ; p = @ ) .


Patients with any ciprofloxacin-containing antibiotic regimen the first @ days in the trial had a higher risk of invasive Candida infection than did patients on any antibiotic regimen not containing ciprofloxacin ( unadjusted hazard ratio = @ ; @ % CI , @-@ @ ; p = @ ; adjusted hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) .


High exposure to antibiotics is associated to increased risk of invasive Candida infection in medical intensive care patients .


Patients with ciprofloxacin-containing regimens had higher risk of invasive Candida infection .


Other antibiotics , such as meropenem , piperacillin/tazobactam , and cefuroxime , were not associated with such a risk .


A combination of aprepitant , a @-HT@ receptor antagonist , and dexamethasone is recommended for the prophylaxis of acute or delayed emesis induced by chemotherapy containing anthracyclines plus cyclophosphamide in patients with breast cancer .


The aim of this study was to verify whether dexamethasone is superior to aprepitant in preventing delayed emesis in patients receiving the same prophylaxis for acute emesis .


A randomized double-blind study comparing aprepitant versus dexamethasone was completed in chemotherapy-naive patients with breast cancer treated with anthracyclines plus cyclophosphamide .


Before chemotherapy , all patients were treated with intravenous palonosetron @ mg , dexamethasone @ mg , and oral aprepitant @ mg .


On days @ and @ , patients randomly received oral dexamethasone @ mg twice per day or aprepitant @ mg once per day .


Primary end point was rate of complete response ( ie , no vomiting or rescue treatment ) from days @ to @ after chemotherapy .


Of @ enrolled patients , @ were evaluable : @ received dexamethasone , and @ received aprepitant .


Day @ complete response rates were similar : @ % for dexamethasone and @ % for aprepitant ( P < @ ) .


From days @ to @ , complete response rates were the same with both antiemetic prophylaxes ( @ % ; P < @ ) , as were results of secondary end points ( ie , complete protection , total control , no vomiting , no nausea , score of Functional Living Index-Emesis ; P < @ ) .


Incidences of insomnia ( @ % v @ % ; P < @ ) and heartburn ( @ % v @ % ; P < @ ) were significantly greater with dexamethasone on days @ to @ .


In patients with breast cancer treated with anthracycline plus cyclophosphamide chemotherapy and receiving the same antiemetic prophylaxis for acute emesis , dexamethasone was not superior to aprepitant but instead had similar efficacy and toxicity in preventing delayed emesis .


Hyperkalemia is a common electrolyte abnormality that may be difficult to manage because of a lack of effective therapies .


Sodium zirconium cyclosilicate is a nonabsorbed cation exchanger that selectively binds potassium in the intestine .


To evaluate the efficacy and safety of zirconium cyclosilicate for @ days in patients with hyperkalemia .


HARMONIZE was a phase @ , multicenter , randomized , double-blind , placebo-controlled trial evaluating zirconium cyclosilicate in outpatients with hyperkalemia ( serum potassium @ mEq/L ) recruited from @ sites in the United States , Australia , and South Africa ( March-August @ ) .


Patients ( n = @ ) received @ g of zirconium cyclosilicate @ times daily in the initial @-hour open-label phase .


Patients ( n = @ ) achieving normokalemia ( @-@ @ mEq/L ) were then randomized to receive zirconium cyclosilicate , @ g ( n = @ patients ) , @ g ( n = @ ) , or @ g ( n = @ ) , or placebo ( n = @ ) daily for @ days .


The primary end point was mean serum potassium level in each zirconium cyclosilicate group vs placebo during days @-@ of the randomized phase .


In the open-label phase , serum potassium levels declined from @ mEq/L at baseline to @ mEq/L at @ hours .


Median time to normalization was @ hours , with @ % of patients ( @ % CI , @ % -@ % ) achieving normokalemia by @ hours and @ % ( @ % CI , @ % -@ % ) by @ hours .


In the randomized phase , serum potassium was significantly lower during days @-@ with all @ zirconium cyclosilicate doses vs placebo ( @ mEq/L -LSB- @ % CI , @-@ @ -RSB- , @ mEq/L -LSB- @ % CI , @-@ @ -RSB- , and @ mEq/L -LSB- @ % CI , @-@ @ -RSB- for @ g , @ g , and @ g ; @ mEq/L -LSB- @ % CI , @-@ @ -RSB- for placebo ; P < @ for all comparisons ) .


The proportion of patients with mean potassium < @ mEq/L during days @-@ was significantly higher in all zirconium cyclosilicate groups vs placebo ( @/@ -LSB- @ % -RSB- , @/@ -LSB- @ % -RSB- , and @/@ -LSB- @ % -RSB- for the @-g , @-g , and @-g groups , vs @/@ -LSB- @ % -RSB- with placebo ; P < @ for each dose vs placebo ) .


Adverse events were comparable between zirconium cyclosilicate and placebo , although edema was more common in the @-g group ( edema incidence : @/@ -LSB- @ % -RSB- , @/@ -LSB- @ % -RSB- , @/@ -LSB- @ % -RSB- , and @/@ -LSB- @ % -RSB- patients in the placebo , @-g , @-g , and @-g groups ) .


Hypokalemia developed in @/@ ( @ % ) and @/@ patients ( @ % ) in the @-g and @-g zirconium cyclosilicate groups , vs none in the @-g or placebo groups .


Among outpatients with hyperkalemia , open-label sodium zirconium cyclosilicate reduced serum potassium to normal levels within @ hours ; compared with placebo , all @ doses of zirconium cyclosilicate resulted in lower potassium levels and a higher proportion of patients with normal potassium levels for up to @ days .


Further studies are needed to evaluate the efficacy and safety of zirconium cyclosilicate beyond @ weeks and to assess long-term clinical outcomes .


Video games have become popular in stroke rehabilitation ; however , the nature of this intervention is not fully understood .


To compare the number of ( a ) purposeful and nonpurposeful repetitions of the weaker upper extremity ( UE ) and ( b ) movement accelerations as assessed by accelerometer activity counts of the weaker and stronger UEs of individuals with chronic stroke while playing video games or participating in traditional therapy .


Twenty-nine individuals ( mean age @ years , @-@ years poststroke ) took part in a group intervention of video - games ( n = @ ) or traditional therapy ( n = @ ) as part of a randomized controlled trial .


During @-@ sessions , participants were video-taped while wearing wrist accelerometers .


Assessors counted the number of repetitions and classified movements as purposeful or nonpurposeful using videotapes .


The weaker UE motor impairments were correlated to movement accelerations , to determine if participants were using their potential during the sessions .


Participants in the video game group performed a median of @ purposeful movements and @ @ activity counts compared to @ purposeful movements and @,@ activity counts in the traditional group ( z = -@ , P = @ and z = -@ , P = @ , respectively ) .


Participants in the traditional group performed a median of @ nonpurposeful ( exercises ) compared with @ in the video game group ( z = -@ , P = @ ) .


Strong significant correlations were found between the motor ability of the weak UE to repetitions of participants in both groups ( r = @ , P < @ ) .


Participants with higher motor ability performed more repetitions .


Video games elicited more UE purposeful repetitions and higher acceleration of movement compared with traditional therapy in individuals with chronic stroke .


To determine whether scatter and grid laser photocoagulation ( laser ) adds benefit to ranibizumab injections in patients with macular edema from retinal vein occlusion ( RVO ) and to compare @-mg with @-mg ranibizumab .


Randomized , double-masked , controlled clinical trial .


Thirty-nine patients with central RVO ( CRVO ) and @ with branch RVO ( BRVO ) .


Subjects were randomized to @ mg or @ mg ranibizumab every @ weeks for @ weeks and re-randomized to pro re nata ranibizumab plus laser or ranibizumab alone .


Mean change from baseline best-corrected visual acuity ( BCVA ) at week @ for BCVA at weeks @ , @ , and @ for second randomization .


Mean improvement from baseline BCVA at week @ was @ and @ letters in the @-mg and @-mg CRVO groups , and @ and @ letters in the @-mg and @-mg BRVO groups .


For CRVO , but not BRVO , there was significantly greater reduction from baseline mean central subfield thickness ( CST ) in the @-mg versus @-mg group ( @ vs. @ m ; P = @ ) .


For the second randomization in CRVO patients , there was no significant difference from week @ BCVA in the ranibizumab plus laser versus the ranibizumab only groups at week @ ( -@ vs. @ letters ) , week @ ( +@ vs. -@ letters ) , or week @ ( +@ vs. -@ letters ) , and a significant increase from week @ mean CST at week @ ( +@ vs. +@ m ; P = @ ) but not weeks @ or @ .


For BRVO , there was a significant reduction from week @ mean BCVA in ranibizumab plus laser versus ranibizumab at week @ ( -@ vs. +@ ; P < @ ) and week @ ( -@ vs. +@ ; P < @ ) , but not week @ , and there were no differences in mean CST change from week @ at weeks @ , @ , or @ .


Laser failed to increase edema resolution or to reduce the ranibizumab injections between weeks @ and @ .


In patients with macular edema resulting from RVO , there was no short-term clinically significant benefit from monthly injections of @-mg versus @-mg ranibizumab injections and no long-term benefit in BCVA , resolution of edema , or number of ranibizumab injections obtained by addition of laser treatment to ranibizumab .


A UK study showed final height in Turner syndrome ( TS ) girls receiving growth hormone is affected by age at pubertal induction and oxandrolone ( Ox ) .


Using data from that study , we analysed the effect of timing of oral ethinylestradiol ( EE@ ) and Ox on height velocity ( HV ) , bone maturation and pubertal progression , and compared growth response in EE@-treated versus spontaneous puberty .


Analysis of HV , bone age and pubertal stage in @ TS girls ( @-@ years ) randomised to Ox ( @ mg/kg/day ; max : @ mg/day ) or placebo from @ years , and EE@ ( year @ : @ g/day ; year @ : @ g/day ; year @ : @/@/@ g/day@ months ) or placebo at @ years with EE@ at @ years .


Girls enrolled at > @ years received EE@ at @ years ( ` late group ' ) .


Fifty-six girls were randomised to EE@ at @ years ( n = @ , @ Ox ) or @ years ( n = @ , @ Ox ) ; there were @ girls in the late group ( @ Ox ) and @ girls with spontaneous puberty ( @ Ox ) .


Girls receiving EE@ at @ versus @ years had faster bone maturation , but neither group showed acceleration .


Ox increased HV without altering bone maturation or pubertal progression .


Girls with spontaneous puberty had greater pubertal growth ( mean PHV @ cm/year ; p < @ ) and height gain ( p < @ ) than EE@-treated girls despite similar mean enrolment height SD and dysmorphology scores .


Pubertal induction with EE@ does not replicate the acceleration observed in unaffected girls or TS girls with spontaneous puberty .


The purpose of this study was to investigate the long-term clinical course of normotensive preperimetric glaucoma ( PPG ) .


The medical records of @ eyes of @ patients with normotensive PPG who underwent intraocular pressure ( IOP ) - lowering therapy were reviewed retrospectively .


The patients had been regularly followed up at @ - to @-month intervals between @ and @ .


Progression was evaluated by comparing the structural changes of serial stereoscopic colour disc and red-free retinal nerve fibre layer ( RNFL ) photographs and by comparing serial visual field ( VF ) test results for functional changes .


Over an average follow-up period of @ years , @ eyes ( @ % ) showed progression in either structural or functional evaluation .


Disc haemorrhage ( DH ) was observed significantly more frequently in the progressing group ( p < @ ) ; however , there were no differences in mean age , gender ratio , follow-up period and ocular characteristics at baseline such as IOP , RNFL defects and global indices of VF between the non-progressing and progressing groups .


Thirty eyes ( @ % ) showed significant angular widening of the localized RNFL defect towards the macula at a mean rate of approximately @/year .


Perimetric glaucoma developed in @ eyes ( @ % ) , and the rate of change in the mean deviation was -@ dB/year .


Preperimetric glaucoma patients with DH or IOP reductions of < @ % from the baseline had a higher probability of RNFL deterioration than patients without DH or IOP reductions of @ % from the baseline by multivariate analysis .


Although the rates of change were typically slow , more than half of normotensive patients with PPG showed statistically significant progressive structural or functional changes in medically treated cases .


DH or IOP reductions of < @ % from the baseline were shown as a significant risk factor for the progression of PPG .


Patients with heart failure ( HF ) who live in rural areas have less access to cardiac services than patients in urban areas .


We conducted a randomized , clinical trial to determine the impact of an educational intervention on the composite end point of HF rehospitalization and cardiac death in this population .


Patients ( n = @ ; age , @ years ; @ % female ; @ % with systolic HF ) were randomized to @ of @ groups : control ( usual care ) , Fluid Watchers LITE , or Fluid Watchers PLUS .


Both intervention groups included a face-to-face education session delivered by a nurse focusing on self-care .


The LITE group received @ follow-up phone calls , whereas the PLUS group received biweekly calls ( mean , @ ; range , @-@ ) until the nurse judged the patient to be adequately trained .


Over @ years of follow-up , @ % of patients ( n = @ ) experienced cardiac death or hospitalization for HF , with no difference among the @ groups in the proportion who experienced the combined clinical outcome ( P = @ ) .


Although patients in the LITE group had reduced cardiac mortality compared with patients in the control group over the @ years of follow-up ( @ % and @ % , respectively ; P = @ ) , there was no significant difference in cardiac mortality between patients in the PLUS group and the control group .


A face-to-face education intervention did not significantly decrease the combined end point of cardiac death or hospitalization for HF .


Increasing the number of contacts between the patient and nurse did not significantly improve outcome .


Physical exercise could improve functional limitations , muscle mass , and health-related quality of life ( HRQoL ) in patients with cirrhosis .


The purpose of this study was to evaluate the efficacy and safety of an exercise programme and leucine supplementation to increase exercise capacity , muscle mass , and HRQoL in patients with cirrhosis .


Seventeen outpatients with cirrhosis were randomized to an exercise group ( n = @ ) or a control group ( n = @ ) in a pilot study .


The programme of moderate exercise was performed for @ weeks under supervision of a physiotherapist .


All patients received oral leucine ( @ g/day ) during the study .


At baseline and at the end of the study , we determined exercise capacity ( @-min walk and @-min step tests ) , anthropometric measurements , and HRQoL by Short Form-@ ( SF-@ ) questionnaire .


We also analyzed safety regarding complications of cirrhosis , liver and renal function , inflammatory response and oxidative stress .


In the exercise group , exercise capacity improved , as shown by the increase in the @-min walk test from @ ( @-@ ) to @ m ( @-@ ) ( p = @ ) , and in the @-min step test ( p = @ ) .


Lower thigh circumference also increased , from @ ( @-@ ) to @ cm ( @-@ ) ( p = @ ) , and the domains of SF-@ general health ( p = @ ) , vitality ( p = @ ) and social function ( p = @ ) improved significantly .


In the control group , no statistically significant changes were observed in any of the parameters .


We did not observe complications of cirrhosis in either group during the study .


A programme of moderate physical exercise together with leucine supplements in patients with cirrhosis is safe and improves exercise capacity , leg muscle mass and HRQoL .


Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement .


The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes .


All @,@ people aged @ years with diagnosed diabetes in Ontario , Canada were studied using population-level administrative databases , with additional clinical outcome data collected from a random sample of @,@ high risk patients .


Family practices were randomly assigned to receive the educational toolkit in June @ ( intervention group ) or May @ ( control group ) .


The primary outcome in the administrative data study , death or non-fatal myocardial infarction , occurred in @,@ ( @ % ) patients in the intervention group and @,@ ( @ % ) in the control group ( p = @ ) .


The primary outcome in the clinical data study , use of a statin , occurred in @ ( @ % ) patients in the intervention group and @ ( @ % ) in the control group ( p = @ ) .


Pre-specified secondary outcomes , including other clinical events , processes of care , and measures of risk factor control , were also not improved by the intervention .


A limitation is the high baseline rate of statin prescribing in this population .


The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes .


Despite being relatively easy and inexpensive to implement , printed educational materials were not effective .


The study highlights the need for a rigorous and scientifically based approach to the development , dissemination , and evaluation of quality improvement interventions .


Increased consumption of omega-@ polyunsaturated fatty acids ( PUFA ) together with lifestyle measures and medications is recommended for the prevention of cardiovascular diseases .


However , the exact mechanisms underlying observed benefits are not well defined .


To this aim , we evaluated the effects of omega-@ PUFA in stable coronary artery disease ( CAD ) patients undergoing percutaneous coronary intervention ( PCI ) on lipoprotein associated phospholipase A@ ( Lp-PLA@ ) mass and activity and their relation to oxidized low-density lipoproteins ( oxy-LDL ) .


In a prospective , double-blind , placebo-controlled , randomized study Lp-PLA@ , oxy-LDL , myeloperoxidase and interleukin-@ were determined at baseline , @-@ days and @ days during administration of omega-@ PUFA @g/day ( n = @ ) or placebo ( n = @ ) .


Treatment with omega-@ PUFA resulted in reduction of Lp-PLA@ mass by @ % , activity by @ ( p = @ for both ) and oxy-LDL by @ % ( p = @ ) at @ days , with no change in myeloperoxidase and interleukin-@ .


Compared with placebo , patients receiving omega-@ PUFA had lower Lp-PLA@ mass by @ % , activity by @ ( p = @ for both ) and oxy-LDL by @ % ( p = @ ) after one month , but not at @-@ days .


There were no correlations between Lp-PLA@ and both myeloperoxidase and oxy-LDL throughout the study .


The multivariate model showed that only treatment with omega-@ PUFA and baseline myeloperoxidase levels were independent predictors of Lp-PLA@ mass changes at one month ( R ( @ ) = @ , P = @ ) .


Administration of omega-@ PUFA can decrease Lp-PLA@ in patients with stable angina undergoing PCI .


This novel effect may contribute to the benefits derived from omega-@ PUF .


It is necessary to develop a new thrombolytic agent which can be used by a single bolus at first aid sites to decrease the time to reperfusion in clinical practice .


HTUPA , a genetically engineered new thrombolytic with a longer half-life , is well qualified .


We aim to compare the thrombolytic efficacy and safety of human tissue urokinase type plasminogen activator ( HTUPA ) to recombinant tissue plasminogen activator ( rt-PA ) in Chinese patients with acute myocardial infarction ( AMI ) .


AMI patients ( n = @ ) were randomized to rt-PA ( a standard protocol ) or HTUPA ( @ mg bolus ) treatment groups .


All patients also received oral aspirin and intravenous heparin .


Coronary angiography was performed @ min after therapy initiation to determine infarct-related coronary artery ( IRA ) patency .


Clinical outcomes and changes of clotting variables , heart rate , blood pressure , left ventricular ejection fraction ( LVEF ) , and electrocardiogram were evaluated .


Patent IRA -LSB- thrombolysis in myocardial infarction ( TIMI ) grade @ or @ -RSB- was observed in @ % of HTUPA-treated patients , compared to @ % of rt-PA-treated patients ( P = @ ) .


TIMI grade @ patency rates were @ % and @ % in the HTUPA and rt-PA groups , respectively ( P = @ ) .


The total patency rate was @ % ( @/@ patients ) in the HTUPA group and @ % ( @/@ patients ) in the rt-PA group ( P = @ ) .


Adverse events were infrequent in both groups , and no significant differences were detected in mortality , re-occlusion rate , revascularization rate , adverse effects , clotting index , LVEF , or electrocardiogram between the two groups .


Intravenous HTUPA had a safe and efficacious profile as good as rt-PA in patients with AMI .


Uterine fibroids are the most common tumour in women of reproductive age .


By the time they are @-years-old around @ % of women will have developed one .


Of these , around half will experience symptoms which will impact negatively on their quality of life .


Hysterectomy is the traditional treatment for women with symptomatic fibroids .


For women who do not wish to undergo a hysterectomy , two invasive treatments are commonly available : myomectomy or uterine artery embolization ( UAE ) .


FEMME is a pragmatic , randomised , open , multi-centre trial examining the quality of life menstruating women with symptomatic fibroids experience after treatment with UAE or myomectomy .


After providing informed consent , @ women with symptomatic fibroids from @ NHS Hospital Trusts and Health Boards across the United Kingdom will undergo randomisation by a centralised computer system to treatment by either UAE or myomectomy .


A minimisation algorithm will be used in order to balance the groups with respect to the following three parameters : the longest dimension of the largest fibroid , the number of fibroids present , and whether the woman currently desires pregnancy.Using validated questionnaires the women 's quality of life will be compared between groups at six months , one year , two years and four years post-procedure , taking into account pre-procedure scores .


An economic evaluation will be conducted alongside the trial to determine the cost-effectiveness of UAE compared with myomectomy.Validated diaries will also be used to compare menstrual blood loss at the same time-points .


The plasma concentration of Anti-Mllerian hormone ( AMH ) , which will act as a proxy measurement of ovarian reserve , will be recorded before the woman has her procedure and then again at six weeks , six months , and twelve months afterwards .


Re-intervention rates will be recorded .


The FEMME trial 's primary outcome is the quality of life women with symptomatic uterine fibroids experience two years after they have been treated with either UAE or myomectomy , as measured by the disease-specific Uterine Fibroid Symptom Quality-of-Life ( UFS-QoL ) questionnaire .


To evaluate the efficacy and safety of acupuncture for residual insomnia and other residual symptoms associated with major depressive disorder ( MDD ) .


@ participants having significant insomnia for more than @ months and a history of MDD ( both based on DSM-IV-TR criteria ) were recruited from @ psychiatric outpatient clinics in Hong Kong from May @ to August @ to receive @ sessions of treatment over @ weeks .


They were randomized to receive acupuncture , minimal acupuncture , or placebo acupuncture .


Primary outcome was sleep diary-derived sleep efficiency .


Secondary outcomes included other sleep diary parameters , actigraphy , anxiety and depressive symptoms , daytime functioning , and adverse events .


The mean difference in sleep diary-derived sleep efficiency at @-week posttreatment was -@ ( @ % CI , -@ to @ ) between the acupuncture and minimal acupuncture groups and was @ ( @ % CI , -@ to @ ) between the acupuncture and placebo acupuncture groups .


A ( @ ) test showed that acupuncture produced a significantly higher proportion of participants achieving sleep-onset latency @ minutes than did minimal acupuncture at @-week posttreatment ( P = @ ) .


However , there was no significant between-group difference in most of the other outcomes .


Treatment blinding was successful , as a majority of participants did not know which treatment they had received .


Acupuncture was well tolerated , but the efficacy was only mild and similar to that of minimal acupuncture and placebo acupuncture .


A high proportion of patients remained clinically significantly affected by insomnia after treatment .


The finding raises certain doubts about the value of acupuncture and underscores the difficulties in the treatment of residual insomnia in MDD .


The neuropeptide oxytocin is implicated in social processing , and recent research has begun to explore how gender relates to the reported effects .


This study examined the effects of oxytocin on social affective perception and learning .


Forty-seven male and female participants made judgments of faces during two different tasks , after being randomized to either double-blinded intranasal oxytocin or placebo .


In the first task , `` unseen '' affective stimuli were presented in a continuous flash suppression paradigm , and participants evaluated faces paired with these stimuli on dimensions of competence , trustworthiness , and warmth .


In the second task , participants learned affective associations between neutral faces and affective acts through a gossip learning procedure and later made affective ratings of the faces .


In both tasks , we found that gender moderated the effect of oxytocin , such that male participants in the oxytocin condition rated faces more negatively , compared with placebo .


The opposite pattern of findings emerged for female participants : they rated faces more positively in the oxytocin condition , compared with placebo .


These findings contribute to a small but growing body of research demonstrating differential effects of oxytocin in men and women .


A non-steroidal , anti-inflammatory moisturizing cream containing rhamnosoft , ceramides , and L-isoleucine ( ILE ) ( pro-AMP cream ) has been recently developed for the specific treatment of atopic eczema ( AE ) of the face .


In this trial , we evaluated the clinical efficacy and tolerability of pro-AMP cream in the treatment of facial AE in children in comparison with an emollient cream .


In a randomized , prospective , assessor-blinded , parallel groups ( @:@ ) controlled trial , @ children ( @ allocated to pro-AMP cream and @ allocated to control group ) with mild-to-moderate chronic AE of the face were enrolled .


Treatments were applied twice daily for a @-week period .


Facial Eczema Severity Score ( ESS ) was evaluated at baseline , week @ , and week @ , by an assessor unaware of treatment allocation .


Investigators Global Assessment ( IGA ) score was assessed at week @ and at week @ .


Tolerability was evaluated at week @ and at week @ using a@-point score ( from @ : low tolerability to @ : very good tolerability ) .


At baseline ESS , mean ( SD ) was @ ( @ ) in the pro-AMP cream group and @ ( @ ) in the control group .


In the pro-AMP group , in comparison with baseline , ESS was significantly reduced to @ ( -@ % ) after @ wks and to @ ( -@ % ) at week @ ( p = @ ) .


In the control group , ESS was reduced to @ ( -@ % ) at week @ and to @ ( -@ % ) at week @ .


At week @ , ESS in pro-AMP cream was significantly lower than the control group ( @ vs. @ ; p = @ ) .


Both products were well tolerated .


Pro-AMP cream has shown to be effective in the treatment of mild-to moderate chronic lesion of AE of the face .


Clinical efficacy was greater in comparison with an emollient cream .


Survival rates after resection of advanced gastric cancer are extremely poor .


An increasing number of patients with gastric carcinomas ( GC ) are therefore being treated with preoperative chemotherapy .


We evaluated @ month survival rate of GC patients that were treated by adding a neoadjuvant chemoradiotherapy before gastrostomy .


Patients with stage II or III gastric adenocarcinomas were enrolled .


The patients divided into two groups : ( A ) Neoadjuvant group that received concurrent chemoradiation before surgery ( @,@ cGy of radiation at @ cGy per day plus chemotherapy with cisplatin and @-fluorouracil , in the first and the end four days of radiotherapy ) .


Resection was attempted @ to @ weeks after end of chemoradiotherapy .


( B ) Adjuvant group that received concurrent chemo-radiation after surgical resection .


Two ( @ % ) patients out of @ patients treated with neoadjuvant chemo-radiotherapy and @ ( @ % ) out of @ in the surgery group survived after @ months .


These rates were not significantly different with per protocol and intention-to-treat analysis .


The median survival time of patients in group A and B were @ and @ months , respectively , again not significantly different .


Survival was significantly greater in patients with well differentiated adenocarcinoma in group B than in group A ( p < @ ) .


According to this study we suggest surgery then chemoradiotherapy for patients with well differentiated gastric adenocarcinoma rather than other approaches .


Additional studies with greater sample size and accurate matching relying on cancer molecular behavior are recommended .


This study assessed the impact of varying lenvatinib crystalline forms in @-mg lenvatinib capsules on drug bioavailability in healthy volunteers .


Lenvatinib @-mg capsules ( low C and high C forms ) .


This randomized , three-period - crossover study compared the pharmacokinetics and safety of two crystalline forms of capsules ( low C-form , < @ % crystalline ; high C-form , @ % crystalline ) to a standard ( ref Cform , @ % crystalline ) .


@ subjects were evaluable for pharmacokinetics .


Test/reference ratios of the geometric least squares means ( LSM ) and @ % confidence intervals ( CI ) for AUC@-t ( t up to @ hours ) , AUC@ - , and Cmax for low C-form vs. ref C-form were @ ( @ , @ ) , @ ( @ , @ ) , and @ ( @ , @ ) , respectively ; and for high C-form vs. ref C-form were @ ( @ , @ ) , @ ( @ , @ ) , and @ ( @ , @ ) , respectively .


The incidence of treatment-emergent adverse events ( TEAE ) and treatment-related adverse events ( TRAE ) were comparable between all formulations ( TEAE range @-@ % ; TRAE range @-@ % ) .


One serious TRAE ( spontaneous abortion ) occurred in the low C-form group .


For both comparisons , the @ % CIs of the test/reference ratios were within the regulatory acceptance range ( @-@ % ) , suggesting that both test formulations ( low Cform and high C-form ) were bioequivalent to the reference formulation for Cmax , AUC@-t , and AUC@ - .


The effect of internal mammary and medial supraclavicular lymph-node irradiation ( regional nodal irradiation ) added to whole-breast or thoracic-wall irradiation after surgery on survival among women with early-stage breast cancer is unknown .


We randomly assigned women who had a centrally or medially located primary tumor , irrespective of axillary involvement , or an externally located tumor with axillary involvement to undergo either whole-breast or thoracic-wall irradiation in addition to regional nodal irradiation ( nodal-irradiation group ) or whole-breast or thoracic-wall irradiation alone ( control group ) .


The primary end point was overall survival .


Secondary end points were the rates of disease-free survival , survival free from distant disease , and death from breast cancer .


Between @ and @ , a total of @ patients underwent randomization .


The majority of patients ( @ % ) underwent breast-conserving surgery .


After mastectomy , @ % of the patients in both groups underwent chest-wall irradiation .


Nearly all patients with node-positive disease ( @ % ) and @ % of patients with node-negative disease received adjuvant systemic treatment .


At a median follow-up of @ years , @ patients had died .


At @ years , overall survival was @ % in the nodal-irradiation group and @ % in the control group ( hazard ratio for death with nodal irradiation , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


The rate of disease-free survival was @ % in the nodal-irradiation group and @ % in the control group ( hazard ratio for disease progression or death , @ ; @ % CI , @ to @ ; P = @ ) , the rate of distant disease-free survival was @ % versus @ % ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) , and breast-cancer mortality was @ % versus @ % ( hazard ratio , @ ; @ % CI , @ to @ ; P = @ ) .


Acute side effects of regional nodal irradiation were modest .


In patients with early-stage breast cancer , irradiation of the regional nodes had a marginal effect on overall survival .


Disease-free survival and distant disease-free survival were improved , and breast-cancer mortality was reduced .


( Funded by Fonds Cancer ; ClinicalTrials.gov number , NCT@ . )


Technological advances raise the possibility of systematic population-based genetic testing for cancer-predisposing mutations , but it is uncertain whether benefits outweigh disadvantages .


We directly compared the psychological/quality-of-life consequences of such an approach to family history ( FH ) - based testing .


In a randomized controlled trial of BRCA@/@ gene-mutation testing in the Ashkenazi Jewish ( AJ ) population , we compared testing all participants in the population screening ( PS ) arm with testing those fulfilling standard FH-based clinical criteria ( FH arm ) .


Following a targeted community campaign , AJ participants older than @ years were recruited by self-referral after pretest genetic counseling .


The effects of BRCA@/@ genetic testing on acceptability , psychological impact , and quality-of-life measures were assessed by random effects regression analysis .


All statistical tests were two-sided .


One thousand , one hundred sixty-eight AJ individuals were counseled , @ consented , @ were randomly assigned ( @ women , @ men ) , and @ were eligible for analysis .


Mean age was @ ( SD = @ ) years .


Thirteen BRCA@/@ carriers were identified in the PS arm , nine in the FH arm .


Five more carriers were detected among FH-negative FH-arm participants following study completion .


There were no statistically significant differences between the FH and PS arms at seven days or three months on measures of anxiety , depression , health anxiety , distress , uncertainty , and quality-of-life .


Contrast tests indicated that overall anxiety ( P = @ ) and uncertainty ( P = @ ) associated with genetic testing decreased ; positive experience scores increased ( P = @ ) ; quality-of-life and health anxiety did not change with time .


Overall , @ % of carriers did not fulfill clinical criteria for genetic testing , and the BRCA@/@ prevalence was @ % .


Compared with FH-based testing , population-based genetic testing in Ashkenazi Jews does n't adversely affect short-term psychological/quality-of-life outcomes and may detect @ % additional BRCA carriers .


The use of nicotine replacement therapy before quitting smoking is called nicotine preloading .


Standard smoking cessation protocols suggest commencing nicotine replacement therapy only on the first day of quitting smoking ( quit day ) aiming to reduce withdrawal symptoms and craving .


However , other , more successful smoking cessation pharmacotherapies are used prior to the quit day as well as after .


Nicotine preloading could improve quit rates by reducing satisfaction from smoking prior to quitting and breaking the association between smoking and reward .


A systematic literature review suggests that evidence for the effectiveness of preloading is inconclusive and further trials are needed .


This is a study protocol for a multicenter , non-blinded , randomized controlled trial based in the United Kingdom , enrolling @ smokers who want to quit , funded by the National Institute for Health Research , Health Technology Assessment program , and sponsored by the University of Oxford .


Participants will primarily be recruited through general practices and smoking cessation clinics , and randomized ( @:@ ) either to use @ mg nicotine patches , or not , for four weeks before quitting , whilst smoking as normal .


All participants will be referred to receive standard smoking cessation service support .


Follow-ups will take place at one week , four weeks , six months and @ months after quit day .


The primary outcome will be prolonged , biochemically verified six-month abstinence .


Additional outcomes will include point prevalence abstinence and abstinence of four-week and @-month duration , side effects , costs of treatment , and markers of potential mediators and moderators of the preloading effect .


This large trial will add substantially to evidence on the effectiveness of nicotine preloading , but also on its cost effectiveness and potential mediators , which have not been investigated in detail previously .


A range of recruitment strategies have been considered to try and compensate for any challenges encountered in recruiting the large sample , and the multicentre design means that knowledge can be shared between recruitment teams .


The pragmatic study design means that results will give a realistic estimate of the success of the intervention if it were to be rolled out as part of standard smoking cessation service practice .


Sirolimus-eluting stents ( SES ) with a biodegradable polymer coating have demonstrated promising results but have not been compared to SES with a durable polymer in high-risk patients .


We compared the efficacy of these @ stent types in patients with acute myocardial infarction ( STEMI ) .


One thousand one hundred ninety-two STEMI patients were randomized to receive SES coated with biodegradable ( n = @ ) or durable polymer ( n = @ ) .


The study end-point was the composite of major adverse cardiac events ( MACE ) including all-cause death , recurrent myocardial infarction ( MI ) , or target lesion revascularization ( TLR ) at @-year follow-up .


Secondary end-points included individual components of primary end-point and stent thrombosis .


Compared with durable polymer SES , the noninferiority of SES with biodegradable polymer coating was established by an absolute risk difference of @ % in the primary end-point ( @ % vs. @ % , P = @ ) and an upper limit of one-sided @ % confidence interval ( CI ) of @ % ( P for noninferiority = @ ) .


Rate of death , recurrent MI , and TLR were @ % and @ % ( HR : @ ; @ % CI : @-@ @ , P = @ ) , @ % and @ % ( HR : @ ; @ % CI : @-@ @ , P = @ ) , and @ % and @ % ( HR : @ ; @ % CI : @-@ @ , P = @ ) in the biodegradable polymer SES and durable polymer SES group at @-year clinical follow-up , respectively .


Despite similar rates of @-day ARC definite/probable stent thrombosis , late stent thrombosis ( stent thrombosis occurring beyond @ days ) was lower with biodegradable polymer SES ( @ % vs. @ % , P = @ ) .


In patients undergoing primary PCI for STEMI , the use of biodegradable polymer SES was associated with noninferior @-year rates of MACE compared with durable polymer SES .


To compare the efficacy differences between acupuncture-moxibustion and physiotherapy interventions in improving proprioception of athletes with lateral collateral ligament injury of the ankle joint .


Thirty patients with injured lateral collateral ligament of ankle joint were randomly divided into acupuncture group ( n = @ ) and physiotherapy group ( n = @ ) .


Patients of the acupuncture group were treated by acupuncture and moxibustion stimulation of Qiuxu ( GB@ ) , Kunlun ( BL @ ) , Shenmai ( BL @ ) , Jiexi ( ST @ ) , and Ashi-points , etc. , and those of the physiotherapy group treated with TDP irradiation of the regional lateral malleolus .


The treatment of the two groups was conducted once the other day , @ times each week , continuously for @ weeks .


Before and after the treatment , the ankle-joint 's active and passive repositioning error angles were measured by using a joint angle ruler .


The average error angle values of active and passive reposition tests of the injured ankle-joint were @ + / - @ and @ + / - @ before the treatment , and @ + / - @ and @ + / - @ after the treatment , respectively in the acupuncture group , being reduced significantly after the treatment ( both P < @ ) .


No significant changes of the average error angle values of both active and passive reposition tests of the ankle-joint were found after the treatment in the physiotherapy group ( P > @ ) .


Comparison between two groups showed that the average error angle , average active and passive reposition angles of the injured ankle in the acupuncture group were evidently lower than those in the physiotherapy group ( P < @ ) .


Acupuncture and moxibustion can effectively improve the proprioception of the injured lateral collateral ligament of the ankle joint in athletes , which is superior to conventional physiotherapy in the therapeutic effect .


Several studies show that psychological treatments relieve symptoms for patients suffering from irritable bowel syndrome ( IBS ) .


However , there are no consistent findings that show what patient characteristics make a psychological treatment more or less likely to result in improvement .


We have previously conducted a study of a newly developed internet-delivered cognitive behavioral therapy ( ICBT ) that emphasized exposure to IBS symptoms and IBS-related situations and reduced symptom-related avoidance .


The study showed that the treatment led to improvement in IBS symptoms compared to a waiting list and that treatment gains were maintained over a @-@ month follow-up period .


The aim of the present study was to investigate several possible predictors of short - and long-term treatment outcome in terms of symptom improvement , based on data collected in the previously conducted treatment trial .


Demographics , comorbid psychological distress , IBS-related fear and avoidance behaviors , and IBS-related disability were investigated as predictors of treatment outcome in the sample consisting of @ participants diagnosed with IBS who had undergone @ weeks of ICBT .


Predictors that were significantly correlated with symptom levels at post-treatment and follow-up were entered into multiple regression analyses that controlled for pre-treatment symptom levels .


There were measures within each domain , i.e. , comorbid psychological distress , IBS-related fear and avoidance behaviors , and IBS-related disability , with the exception of demographic data , that were correlated with the symptom levels at post-treatment and follow-up .


However , when these were entered into a multiple regression analyses that controlled for pre-treatment levels , none remained a significant predictor of the post-treatment and follow-up symptomatic status .


The study did not find any individual characteristics that made patients more or less likely to respond to the exposure-based ICBT .


The finding that comorbid psychological distress did not predict outcome is in accordance with previous studies .


Reliable predictors for response to any type of psychological treatment for IBS remain to be established .


To evaluate the effect of luteal phase progesterone support on pregnancy rates in women with polycystic ovary syndrome ( PCOS ) who were treated for clomiphene citrate-resistant anovulatory infertility with ovulation induction and intrauterine insemination ( OI / IUI ) .


This randomized study included @ clomiphene citrate-resistant PCOS patients .


All patients underwent ovulation induction with recombinant follicle-stimulating hormone and intrauterine insemination , up to @ cycles , and were randomized into @ groups : ( @ ) luteal support with progesterone or ( @ ) a control group .


The main outcomes were clinical pregnancy rates and live birth rates per cycle .


Demographic data were not different between the study and control groups .


Cycle characteristics were found to be homogeneous between groups .


A total of @ pregnancies were achieved ( @ % pregnancy rate per cycle ) .


The clinical pregnancy rate and live birth rate per cycle in progesterone supported cycles were @ % and @ % , respectively .


There might be a clinical benefit of luteal progesterone supplementation on OI/IUI cycles for women with PCOS .


Although we did not reach a statistically significant difference between the @ groups , luteal-supported cycles demonstrated a @ % higher clinical pregnancy rate and @ % higher live birth rate .


Dementia-care mapping ( DCM ) is a cyclic intervention aiming at reducing neuropsychiatric symptoms in people with dementia in nursing homes .


Alongside an @-month cluster-randomized controlled trial in which we studied the effectiveness of DCM on residents and staff outcomes , we investigated differences in costs of care between DCM and usual care in nursing homes .


Dementia special care units were randomly assigned to DCM or usual care .


Nurses from the intervention care homes received DCM training , a DCM organizational briefing day and conducted the @-months DCM-intervention twice during the study .


A single DCM cycle consists of observation , feedback to the staff , and action plans for the residents .


We measured costs related to health care consumption , falls and psychotropic drug use at the resident level and absenteeism at the staff level .


Data were extracted from resident files and the nursing home records .


Prizes were determined using the Dutch manual of health care cost and the cost prices delivered by a pharmacy and a nursing home .


Total costs were evaluated by means of linear mixed-effect models for longitudinal data , with the unit as a random effect to correct for dependencies within units .


@ units from @ nursing homes , including @ residents and @ nursing staff members participated in the cost analyses .


Analyses showed no difference in total costs .


However certain changes within costs could be noticed .


The intervention group showed lower costs associated with outpatient hospital appointments over time ( p = @ ) than the control group .


In both groups , the number of falls , costs associated with the elderly-care physician and nurse practitioner increased equally during the study ( p < @ ) .


DCM is a cost-neutral intervention .


It effectively reduces outpatient hospital appointments compared to usual care .


Other considerations than costs , such as nursing homes ' preferences , may determine whether they adopt the DCM method .


Although catheter ablation of isthmus-dependent atrial flutter ( AFL ) is successful at eliminating the target arrhythmia , many patients subsequently experience new-onset atrial fibrillation ( AF ) .


The aim of this study was to determine whether AF can be prevented by prophylactic pulmonary vein ablation in patients with AFL .


A prospective , single-blind , randomized clinical trial in patients whose sole arrhythmia was AFL without AF was conducted .


Patients were randomized to cavotricuspid isthmus ablation alone or with concomitant pulmonary vein isolation .


All patients received an implantable cardiac monitor .


Fifty patients completed the trial , and patients were well matched .


Isthmus ablation was successful in all patients ; pulmonary vein isolation was successful in @ ( @ % ) randomized patients .


Procedure ( P < @ ) and fluoroscopy ( P < @ ) times were longer in the combined ablation group .


More patients in the isthmus ablation-only group experienced new-onset AF during follow-up ( @ % vs. @ % ; P = @ ) .


The @-year AF burden also favored the combined ablation group compared with the isthmus ablation-only group ( @ % vs. @ % ; P = @ ) .


In the isthmus ablation-only group , @ ( @ % ) patients subsequently underwent another ablation for AF .


The performance of pulmonary vein isolation and male sex were independent predictors of freedom from AF .


In the PREVENT-AF Study I randomized clinical trial of patients in whom only typical AFL had been observed clinically , the addition of pulmonary vein isolation to cavotricuspid isthmus ablation resulted in a marked reduction of new-onset AF during clinical follow-up as assessed with a continuous implantable cardiac monitor .


Severe acute pancreatitis is a life-threatening disease .


Patients with peripancreatic necrotic infection often require surgical removal of necrotic infected tissue and a wide debridement will cause blood loss and worsen the condition .


To assess whether treatment with NovoSeven , a recombinant activated FVII ( rFVIIa ) , could improve coagulation function and therefore reduce blood loss , blood transfusion and all-cause mortality during necrosectomy in patients with infected necrosis secondary to severe acute pancreatitis .


Severe acute pancreatitis patients admitted to Nanjing Jinling Hospital for necrosectomy were enrolled and randomized to receive either standard treatment or standard treatment plus an intravenous infusion of rFVIIa ( @g per kilogram of body weight per hour ) before operation .


The prospectively defined primary end points were perioperative coagulation parameters ( prothrombin time , activated partial thromboplastin time ) , blood transfusion unit and blood loss .


The secondary end points were operation time , ICU stay and all-cause mortality at @days after the operation .


A total of @ patients were enrolled ( @ in the rFVIIa group and @ in the control group ) .