At baseline and @ hours after treatment , we assessed ( @ ) flow-mediated dilation of brachial artery ; ( @ ) coronary flow reserve , ejection fraction , systemic arterial compliance , and resistance by echocardiography ; ( @ ) left ventricular global longitudinal and circumferential strain , peak twisting , untwisting velocity by speckle tracking ; and ( @ ) interleukin-@ , nitrotyrosine , malondialdehyde , protein carbonyl , and Fas/Fas ligand levels .


At baseline , patients with CAD had @-fold higher interleukin-@ , protein carbonyl , higher nitrotyrosine , malondialdehyde , and Fas/Fas ligand than non-CAD ( P < @ ) .


After anakinra , there was a greater improvement of flow-mediated dilation ( @ % versus @ % ) , coronary flow reserve ( @ % versus @ % ) , arterial compliance ( @ % versus @ % ) , resistance ( -@ % versus @ % ) , longitudinal strain ( @ % versus @ % ) , circumferential strain ( @ % versus @ % ) , peak twisting ( @ % versus @ % ) , untwisting velocity ( @ % versus @ % ) , ejection fraction ( @ % versus @ % ) , apoptotic and oxidative markers , and , in particular , of protein carbonyl ( @ % versus @ % ) in CAD than in non-CAD patients ( P < @ ) .


No changes in the examined markers were observed after placebo .


Interleukin-@ inhibition causes a greater improvement in endothelial , coronary aortic function in addition to left ventricular myocardial deformation and twisting in rheumatoid arthritis patients with CAD than in those without .


Preoperative short-term radiotherapy ( PRT ) in combination with total mesorectal excision ( TME ) has shown to improve local control in rectal cancer treatment , however without a survival benefit and at the cost of increased morbidity .


The current study investigates the long-term health-related quality of life ( HRQL ) of patients @ years after treatment in the Dutch TME trial .


In the TME trial ( @-@ ) @ Dutch patients with rectal cancer were treated with TME and randomly assigned to PRT ( @ @ Gy ) .


In @ HRQL was evaluated in surviving patients ( n = @ ) using a questionnaire combining EORTC QLQ-C@ , EORTC QLQ-CR@ and additional questions .


Results were obtained from @ patients ( @ % ) , with a median follow up of @ years .


PRT+TME patients without stoma reported more faecal leakage and higher stool frequency , resulting in increased need of pads .


Furthermore , irradiated males reported more erection problems .


However , radiotherapy did not have negative effects on overall functioning .


Compared with Dutch population , patients in both treatment arms reported a small decrease in overall functioning and males reported less sexual activity , interest and enjoyment and more erection difficulties .


Irradiated females reported more vaginal dryness and more pain at intercourse compared with Dutch population .


Long-term HRQL evaluation shows that treatment-related symptoms are still present @ years after treatment for rectal cancer .


Radiotherapy increased bowel dysfunction in patients without stoma .


Compared with the Dutch population , both groups reported increased sexual dysfunction .


Despite these treatment-related symptoms , there was no difference in overall functioning and global health between TME and PRT+TME .


We investigated the temporal changes in circulating levels of markers of extracellular cardiac matrix ( ECCM ) turnover and their relationship with infarct size ( IS ) , ejection fraction ( EF ) , and left ventricular ( LV ) volumes , determined by serial cardiac magnetic resonance ( CMR ) imaging in patients with first-time ST-elevation myocardial infarction ( STEMI ) .


Forty-two patients with a first-time STEMI , successfully revascularized by primary percutaneous coronary intervention ( pPCI ) had serum samples taken prior to pPCI , @ , @ days , @ months , and @ year following STEMI for the analysis of the markers of collagen synthesis , and collagen degradation .


Late enhancement and cine CMR was performed on Days @ , @ , @ months , and @-year post-STEMI .


There was a significant increase in type I collagen degradation following STEMI that was not accompanied by an increase in collagen type I synthesis until @ months and @ year .


In contrast to the delay in type I collagen synthesis , there was an immediate increase in type III collagen synthesis that was sustained for @ year .


N-terminal procollagen type I levels assessed prior to pPCI were predictive of adverse LV remodelling at all CMR time-points .


Our findings indicate a net type I collagen breakdown in the first week following STEMI compensated by an early increase in collagen type III synthesis .


There is an increase in both type I and III collagen synthesis markers at @ months and @ year , indicating a persistent increase in collagen turnover even in these apparently successfully treated patients .


Virtually all early cases of knee osteoarthritis have degenerative medial meniscus lesions accompanying the chondral defects on MRI .


It is difficult to determine if the symptoms are caused by the unstable meniscus or by osteoarthritis , hence unclear guidance towards treatment .


We , therefore , aimed to determine the clinical improvement following arthroscopic meniscectomy compared to intraarticular administration of corticosteroids for degenerative ruptures of the medial meniscus in the presence of early stage medial compartment knee osteoarthritis .


We included @ consecutive cases of nontraumatic symptomatic knees which had degenerative lesions of the medial compartment ( cartilage and meniscus ) on MRI 's .


They were randomized to receive either intraarticular steroid injection or arthroscopic debridement .


We also analyzed the correlation between BMI , age , gender , MRI , intraoperative aspect of the meniscus and cartilage and clinical improvement using the Oxford Knee Score up to one year .


At one month there was significant improvement of the scores for all the examined cases .


Also at one month , the arthroscopic group performed better in terms of symptom improvement .


This was maintained for @ % of the knees in the arthroscopic group and @ % in the intraarticular steroid injection respectively , out of those available for follow up at one year .


At one month , symptoms reappeared for @ patients in the steroid group and @ in the arthroscopy respectively .


Gender and age did not correlate with treatment , whereas extrusion of the meniscus , bone marrow edema , duration of the clinical symptoms , obesity and a low preoperative score were negative prognostic factors .


Degenerative medial meniscal tears , in the presence of osteoarthritis , can only marginally benefit from arthroscopic debridement over intraarticular steroid injections in short term follow up .


When considering individual cases , factors become more predictive when analyzed in group .


To assess the efficacy of an exercise program on a whole-body vibration platform ( WBV ) in improving body balance and muscle performance and preventing falls in institutionalized elderly people .


A multicentre randomized parallel assessor-blinded clinical trial was conducted in elderly persons living in nursing homes .


Participants were randomized to an exercise program performed either on a whole body vibratory platform ( WBV plus exercise group ) or on a stationary surface ( exercise group ) .


The exercise program for both groups consisted of static and dynamic exercises ( balance and strength training over a @-week training period of @ sessions per week ) .


The frequency applied on the vibratory platform was @ to @ Hz and amplitude was @ to @ mm .


The primary outcome measurement was static/dynamic body balance .


Secondary outcomes were muscle strength and number of falls .


Efficacy was analyzed on an intention-to-treat basis and per protocol .


The effects of the intervention were evaluated using the t test , Mann-Whitney test , or chi-square test , depending on the type of outcome .


Follow-up measurements were collected @ weeks and @ months after randomization .


A total of @ participants from @ centers were included : @ in the WBV plus exercise group and @ in the control group .


Mean age was @ years , and @ % were women .


The Tinetti test score showed a significant overall improvement in both groups ( P < @ ) .


No significant differences were found between groups at week @ ( P = @ ) or month @ ( P = @ ) .


The Timed Up and Go test did not improve ( P = @ ) in either group over time , and no significant differences were found between groups at week @ ( P = @ ) or month @ ( P = @ ) .


Muscle performance results from the @ Sit-To-Stand tests improved significantly across time ( P = @ ) , but no statistically significant differences were found between groups at week @ ( P = @ ) or month @ ( P = @ ) .


A total of @ falls ( @ % ) were recorded during the follow-up period , with no differences between groups ( P = @ ) .


Exercise program on a vibratory platform provides benefits similar to those with exercise program on a stationary surface in relation to body balance , gait , functional mobility , and muscle strength in institutionalized elderly people .


Longer studies in larger samples are needed to assess falls .


Depressive disorders are highly prevalent in the working population and are associated with excessive costs .


The evidence for effective worker-directed interventions for employees with depressive symptoms is limited .


Treating employees with depressive symptoms before sick leave via the Internet could be beneficial and cost saving .


In this study , we developed and tested the effectiveness of a Web-based guided self-help course for employees with depressive symptoms .


We report on the posttreatment effectiveness of the intervention .


This study is a two-arm randomized controlled trial comparing a Web-based guided self-help course to care as usual ( CAU ) .


We recruited employees from @ different companies via the companies ' intranet and posters .


The main inclusion criterion was elevated depressive symptoms as measured by a score of @ on the Center for Epidemiological Studies Depression scale ( CES-D ) .


The intervention ( Happy@Work ) was based on problem-solving treatment and cognitive therapy and consisted of @ weekly lessons .


Participants were asked to submit their weekly assignment via the website after completion .


They subsequently received feedback from a coach via the website .


Self-report questionnaires on depressive symptoms ( CES-D ; primary outcome ) , anxiety measured by the Hospital Anxiety and Depression Scale ( HADS ) , burnout measured by the Maslach Burnout Inventory ( MBI ) , and work performance measured by the Health and Work Performance Questionnaire ( HPQ ; secondary outcomes ) were completed at baseline and at posttreatment .


A total of @ employees were randomized to either the intervention group ( n = @ ) or CAU ( n = @ ) .


The posttreatment assessment was completed by @ ( @ % ) participants .


Both the intervention and the CAU group showed significant improvements in the primary outcome of depressive symptoms , but no differences between the conditions was found ( d = @ , @ % CI -@ to @ , P = @ ) .


Significant but small effects in favor of the intervention group were found for anxiety symptoms ( d = @ , @ % CI -@ to @ , P = @ ) and exhaustion ( d = @ , @ % CI -@ to @ , P = @ ) .


This study showed that a Web-based guided self-help course for employees with depressive symptoms was not more effective in reducing depressive symptoms among employees than CAU .


Large improvements in depressive symptoms in the CAU group were unforeseen and potential explanations are discussed .


Chronic hepatitis C virus ( HCV ) infection is characterised by a failure of virus-specific CD@ + T cells that is mainly caused by viral escape and T cell exhaustion .


Constant antigen stimulation has been suggested to contribute to HCV-specific CD@ + T cell exhaustion .


However , IFN-based therapies failed to recover HCV-specific CD@ + T cell function suggesting that the damage to CD@ + T cells may be permanent even after antigen removal .


It was therefore the objective of this study to analyse the impact of inhibition of ongoing viral replication by IFN-free therapy with direct acting antivirals ( DAA ) on the phenotype and function of HCV-specific CD@ + T cells .


Virus-specific CD@ + T cells obtained from a patient cohort of @ previously untreated chronically infected patients undergoing IFN-free therapy with a combination of faldaprevir ( a protease inhibitor ) and deleobuvir ( a non-nucleoside polymerase inhibitor ) with or without ribavirin were analysed ex vivo and after in vitro expansion at baseline , wk@ , wk @ , and after treatment .


Our results show the rapid restoration of proliferative HCV-specific CD@ + T cells in the majority of patients with SVR@ within @ weeks of therapy suggesting that IFN-free therapy mediated antigen removal may restore CD@ + T cell function .


This study indicates a specific restoration of proliferative HCV-specific CD@ + T cells under IFN-free therapy .


This is in contrast to PegIFN-based therapies that have been shown not to restore T cell function during and after chronic infection .


Obesity is associated with metabolic dysfunctions , which may be mediated by changes in adipose tissue signaling factors .


These molecules are denoted as Adipose Tissue Generated Mediators of CardioVascular Risk ( ATGMCVR ) here , and include leptin , adiponectin , C-reactive protein ( CRP ) , interleukin @ ( IL-@ ) , tumor necrosis factor alpha ( TNF ) , and plasminogen activator inhibitor @ ( PAI-@ ) .


This study examined the effect of a weight loss program on ATGMCVR in obese adults with prediabetes .


Subjects were randomized to usual care ( UC ; n = @ ) or lifestyle weight loss groups ( LWL ; n = @ ) .


LWL was a community-based weight loss intervention to promote physical activity and healthy eating .


ATGMCVR at @-year were compared between groups by analysis of covariance ; baseline value of the mediator was the covariate .


Baseline means for ATGMCVR were compared between those with ( n = @ ) and without ( n = @ ) metabolic syndrome ( MetS ) .


At baseline , subjects were @ ( SD ) years , @ % female , with a BMI of @kg/m ( @ ) .


One-year weight loss ( % ) was @ % for LWL and @ % for UC .


Group differences at @-year were noted ( adjusted means -LSB- @ % CI -RSB- for UC and LWL , respectively ) for adiponectin ( @ -LSB- @ , @ -RSB- ; @,@ -LSB- @ , @,@ -RSB- ng/ml ; p = @ ) , leptin ( @ -LSB- @ , @ -RSB- ; @ -LSB- @ , @ -RSB- ng/ml ; p = @ ) , IL-@ ( @ -LSB- @ , @ -RSB- ; @ -LSB- @ , @ -RSB- pg/ml ; p = @ ) , and PAI-@ ( @ -LSB- @ , @ -RSB- ; @ -LSB- @ , @ -RSB- pg/ml ; p = @ ) .


No differences in baseline ATGMCVR were seen between subjects with and without MetS .


These findings suggest ATGMCVR can be improved with weight loss ; larger studies are needed to determine if improvements in metabolic dysfunction are related to changes in ATGMCVR .


The blood glucose-lowering effects of - glucan from oats and barley depend on the amounts consumed and their rheological properties .


This has been recently challenged with growing evidence that the food matrix may also be an important factor in predicting its physiological response .


The objective of this study was to examine the effects of varying doses of - glucan from oats and barley and added to a snack bar on postprandial glycemia .


In a randomized crossover study , @ healthy males and females consumed one of @ snack bars containing @ ( control ) , @ , @ , and @ g of - glucan derived from oats or barley or @ white bread controls .


All treatments contained @ g of available carbohydrate .


Blood glucose concentrations were measured after ingestion of the treatments over @ hours .


Incorporation of @ to @ g of - glucan into snack bars had no additional glucose-lowering benefits irrespective of dose and source compared to the control bars ( @ g - glucan ) , suggesting that both the solid food matrix and composition of the bars may play a role in their effects on glycemic response .


All bars reduced blood glucose area under the curve ( AUC ) by an average of @ % ( p < @ ) compared to the mean of the @ white bread controls .


Adding - glucan from oats and barley to the snack bar formulation used in this study did not yield any additional benefits beyond the glucose-lowering effects of the snack bars themselves .


A randomized clinical trial assessing the difference in quality of life and clinical outcomes between delayed and simultaneous phlebectomies in the context of endovenous truncal vein ablation .


Endovenous ablation has replaced open surgery as the treatment of choice for truncal varicose veins .


Timing of varicosity treatment is controversial with delayed and simultaneous pathways having studies advocating their benefits .


A previous small randomized study has shown improved outcomes for simultaneous treatment .


Patients undergoing local anesthetic endovenous thermal ablation were randomized to either simultaneous phlebectomy or delayed varicosity treatment .


Patients were reviewed at @ weeks , @ months , and @ year with clinical and quality of life scores completed , and were assessed at @ weeks for need for further varicosity intervention , which was completed with either ultrasound-guided foam sclerotherapy or local anesthetic phlebectomy .


Duplex ultrasound assessment of the treated trunk was completed at @ months .


@ patients were successfully recruited and treated out of @ suitable patients from a screened population of @ .


Patients in the simultaneous group ( n = @ ) showed a significantly improved Venous Clinical Severity Score at all time points , @ % of the delayed group required further treatment compared with @ % of the simultaneous group ( P < @ ) .


There were no deep vein thromboses , with @ superfificial venous thrombosis in each group .


Combined endovenous ablation and phlebectomy delivers improved clinical outcomes and a reduced need for further procedures , as well as early quality of life improvements .


Although guidelines recommend in-person counseling before BRCA@/BRCA@ gene testing , genetic counseling is increasingly offered by telephone .


As genomic testing becomes more common , evaluating alternative delivery approaches becomes increasingly salient .


We tested whether telephone delivery of BRCA@/@ genetic counseling was noninferior to in-person delivery .


Participants ( women age @ to @ years who did not have newly diagnosed or metastatic cancer and lived within a study site catchment area ) were randomly assigned to usual care ( UC ; n = @ ) or telephone counseling ( TC ; n = @ ) .


UC participants received in-person pre - and post-test counseling ; TC participants completed all counseling by telephone .


Primary outcomes were knowledge , satisfaction , decision conflict , distress , and quality of life ; secondary outcomes were equivalence of BRCA@/@ test uptake and costs of delivering TC versus UC .


TC was noninferior to UC on all primary outcomes .


At @ weeks after pretest counseling , knowledge ( d = @ ; lower bound of @ % CI , -@ ) , perceived stress ( d = -@ ; upper bound of @ % CI , @ ) , and satisfaction ( d = -@ ; lower bound of @ % CI , -@ ) had group differences and confidence intervals that did not cross their @-point noninferiority limits .


Decision conflict ( d = @ ; upper bound of @ % CI , @ ) and cancer distress ( d = -@ ; upper bound of @ % CI , @ ) did not cross their @-point noninferiority limit .


Results were comparable at @ months .


TC was not equivalent to UC on BRCA@/@ test uptake ( UC , @ % ; TC , @ % ) .


TC yielded cost savings of $ @ per patient .


Genetic counseling can be effectively and efficiently delivered via telephone to increase access and decrease costs .


To evaluate the effectiveness of a @-month multicomponent obesity prevention intervention .


Setting .


@ elementary schools in Santiago , Chile .


Subjects .


@-@y old low-income children ( N = @ ) .


Randomized controlled study ; @ intervention/@ control schools .


We trained teachers to deliver nutrition contents and improve the quality of PE classes .


We determined % healthy snacks brought from home , children 's nutrition knowledge , nutritional status , duration of PE classes , and % time in moderate/vigorous activity ( MVA ) .


Effectiveness was determined by comparing BMI Z between intervention and control children using PROCMIXED .


% obesity increased in boys from both types of schools and in girls from control schools , while decreasing in girls from intervention schools ( all nonsignificant ) .


% class time in MVA declined ( @-@ @ ) while remaining unchanged ( @-@ @ % ) in classes conducted by untrained and trained teachers , respectively .


In boys , BMI Z declined ( @-@ @ ) and increased ( @-@ @ ) in intervention and control schools , respectively .


In girls , BMI Z remained unchanged in intervention schools , while increasing significantly in control schools ( @-@ @ , P = @ ) .


Interaction group time was significant for boys ( P < @ ) and girls ( P = @ ) .


This intervention was effective in controlling obesity , but not preventing it .


Even though impact was small , results showed that when no intervention is implemented , obesity increases .


Although the potential benefits of @-dimensional ( @-D ) vs @-dimensional ( @-D ) and high-definition ( HD ) vs standard-definition ( SD ) endoscopic visualization have long been recognized in other surgical fields , such endoscopes are generally considered too large and bulky for use within the brain .


The recent development of @-D and HD neuroendoscopes may therefore herald improved depth perception , better appreciation of anatomic details , and improved overall surgical performance .


To compare simultaneously the effectiveness of @-D vs @-D and HD vs SD neuroendoscopy .


Ten novice neuroendoscopic surgeons were recruited from a university hospital .


A preclinical randomized crossover study design was adopted to compare @-D vs @-D and HD vs SD neuroendoscopy .


The primary outcomes were time to task completion and accuracy .


The secondary outcomes were perceived task workload using the NASA ( National Aeronautics and Space Administration ) Task Load Index and subjective impressions of the endoscopes using a @-point Likert scale .


Time to task completion was significantly shorter when using the @-D vs the @-D neuroendoscopy ( P = @ ) , and accuracy of probe placement was significantly greater when using the HD vs the SD neuroendoscopy ( P = @ ) .


We found that @-D endoscopy significantly improved perceived depth perception ( P < @ ) , HD endoscopy significantly improved perceived image quality ( P < @ ) , and both improved participants ' overall impression ( P < @ ) .


Three-dimensional neuroendoscopy and HD neuroendoscopy have differing but complementary effects on surgical performance , suggesting that neither alone can completely compensate for the lack of the other .


There is therefore strong preclinical evidence to justify @-D HD neuroendoscopy .


To present the safety and efficacy of intravitreal implants releasing @ g/day fluocinolone acetonide ( FAc ) in patients with chronic versus nonchronic diabetic macular edema ( DME ) .


To assess ocular characteristics , anatomic changes , and re-treatment and ancillary therapies that may explain the differential treatment effect seen with intravitreal implants releasing FAc @ g/day in patients with chronic and nonchronic DME .


An overall benefit-to-risk assessment for the FAc @-g / day and FAc @-g / day doses has been reported previously .


Preplanned subgroup analysis of chronic ( duration of diagnosis , @ years ) and nonchronic ( duration of diagnosis , < @ years ) DME in patients from @ randomized , sham injection-controlled , double-masked , multicenter clinical trials .


Patients with persistent DME despite @ or more macular laser treatment were randomized @:@:@ to sham injection ( n = @ ) , FAc @ g/day ( n = @ ) , or FAc @ g/day ( n = @ ) .


Patients received study drug or sham injection and after @ weeks were eligible for rescue laser .


Based on re-treatment criteria , additional masked study drug could be given after @ year .


Percentage of patients with improvement of @ letters or more from baseline .


Secondary outcomes included other parameters of visual function and foveal thickness .


At month @ , the difference between FAc @ g/day and sham control in the percentage of patients who gained @ letters or more was significantly greater in chronic DME patients ( FAc @ g/day , @ % vs. sham , @ % ; P < @ ) , compared with patients with nonchronic DME ( FAc @ g/day , @ % vs. sham , @ % ; P = @ ) .


The greater response in patients with chronic DME was not associated with baseline ocular characteristics , changes in anatomic features , or differences in re-treatment or ancillary therapies .


The ocular adverse event profile for FAc @ g/day was similar regardless of DME duration .


This is the first published analysis correlating duration of diagnosis of DME with treatment effect .


In patients with chronic DME , FAc @ g/day provides substantial visual benefit for up to @ years and would provide an option for patients who do not respond to other therapy .


Ischemic postconditioning ( PCON ) appears as a potentially beneficial tool in ST-segment elevation myocardial infarction ( STEMI ) .


We evaluated the effect of PCON on microvascular obstruction ( MVO ) in STEMI patients and in an experimental swine model .


A prospective randomized study in patients and an experimental study in swine were carried out in two university hospitals in Spain .


@ consecutive STEMI patients were randomized to undergo primary angioplasty followed by PCON or primary angioplasty alone ( non-PCON ) .


Using late gadolinium enhancement cardiovascular magnetic resonance , infarct size and MVO were quantified ( % of left ventricular mass ) .


In swine , using an angioplasty balloon-induced anterior STEMI model , MVO was defined as the % of area at risk without thioflavin-S staining .


In patients , PCON ( n = @ ) in comparison with non-PCON ( n = @ ) did not significantly reduce MVO ( @ -LSB- @-@ @ -RSB- % vs. @ -LSB- @-@ @ -RSB- % p = @ ) or IS ( @ @ % vs. @ @ % , p = @ ) .


MVO ( > @ segment in the @-segment model ) occurred in @/@ ( @ % ) PCON and in @/@ ( @ % ) non-PCON patients , p = @ .


No significant differences were observed between PCON and non-PCON patients in left ventricular volumes , ejection fraction or the extent of hemorrhage .


In the swine model , MVO occurred in @/@ ( @ % ) PCON and in @/@ ( @ % ) non-PCON pigs , p = @ .


The extent of MVO ( @ @ % vs. @ @ % , p = @ ) and infarct size ( @ @ % vs. @ @ % , p = @ ) was not reduced in PCON compared with non-PCON pigs .


Ischemic postconditioning does not significantly reduce microvascular obstruction in ST-segment elevation myocardial infarction .


Clinical Trial Registration http://www.clinicaltrials.gov .


Unique identifier : NCT@ .


Sub-anesthetic ketamine infusions may benefit a variety of psychiatric disorders , including addiction .


Though ketamine engenders transient alterations in consciousness , it is not known whether these alterations influence efficacy .


This analysis evaluates the mystical-type effects of ketamine , which may have therapeutic potential according to prior research , and assesses whether these effects mediate improvements in dependence-related deficits , @h postinfusion .


Eight cocaine dependent individuals completed this double-blind , randomized , inpatient study .


Three counter-balanced infusions separated by @h were received : lorazepam ( @mg ) and two doses of ketamine ( @ mg/kg and @ mg/kg , with the former dose always preceding the latter ) .


Infusions were followed within @min by measures of dissociation ( Clinician Administered Dissociative Symptoms Scale : CADSS ) and mystical-type effects ( adapted from Hood 's Mysticism Scale : HMS ) .


At baseline and @h postinfusion , participants underwent assessments of motivation to stop cocaine ( University of Rhode Island Change Assessment ) and cue-induced craving ( by visual analogue scale for cocaine craving during cue exposure ) .


Ketamine led to significantly greater acute mystical-type effects ( by HMS ) relative to the active control lorazepam ; ketamine @ mg/kg was associated with significantly higher HMS scores than was the @ mg/kg dose .


HMS score , but not CADSS score , was found to mediate the effect of ketamine on motivation to quit cocaine @h postinfusion .


These findings suggest that psychological mechanisms may be involved in some of the anti-addiction benefits resulting from ketamine .


Future research can evaluate whether the psychoactive effects of ketamine influence improvements in larger samples .


Although facial hyperhidrosis has been frequently associated with a diminished quality of life , various conservative modalities for its management are still far from satisfactory .


To evaluate the antiperspirant efficacy and safety of the topical glycopyrrolate on facial hyperhidrosis at specified posttreatment intervals .


Thirty-nine patients with facial hyperhidrosis were enrolled and treated with @ % topical glycopyrrolate on one-half of the forehead , whereas the other half of the forehead was treated with a placebo .


All patients applied topical glycopyrrolate or placebo once a day for nine successive days .


Each evaluation included weighing sweat and assessing the Hyperhidrosis Disease Severity Scale ( HDSS ) score and any adverse effects .


Compared with the placebo-treated sides , topical glycopyrrolate-treated sides showed a reduction in the rate of sweat production at the forehead of @ @ % ( mean SD ) at @ min after the first application ( day @ ) , @ @ % at @ h after the first application ( day @ ) and @ @ % at @ h after eight additional successive daily applications ( day @ ) ( all P < @ ) .


There was a little more decrease in HDSS score with the topical glycopyrrolate-treated half of the forehead , but the difference was not statistically significant ( P > @ ) .


No serious adverse events were reported during the course of this study .


Only one patient developed a transient headache after treatment .


Topical glycopyrrolate application appears to be significantly effective and safe in reducing excessive facial perspiration .


To examine the association between Mini-Mental State Examination ( MMSE ) score and motor vehicle crash ( MVC ) risk in a large cohort of community-dwelling participants with cardiovascular disease ( CVD ) or diabetes mellitus .


Prospective observational study .


Participants enrolled in the Ongoing Telmisartan Alone and in Combination With Ramipril Global End Point Trial and Telmisartan Randomized Assessment Study in ACE Intolerant Subjects with Cardiovascular Disease clinical trial , which included individuals aged @ and older with CVD or diabetes mellitus .


Totally @,@ frequent drivers ( defined as driving at least once per week ) who had completed a baseline MMSE .


Involvement in a MVC as the driver .


Baseline MMSE score was divided into four categories : @ , @-@ , @-@ , and < @ .


The median MMSE score was @ ( interquartile range @-@ ) , and @ ( @ % ) has a MMSE score of less than @ at baseline .


After a mean follow-up of @ years , @,@ ( @ % ) participants were drivers in a MVC .


Lower scores were not associated with future MVCs ( MMSE score @-@ , hazard ratio ( HR ) = @ , @ % confidence interval ( CI ) = @-@ @ ) ; MMSE score @-@ , HR = @ , @ % CI = @-@ @ ; MMSE score < @ , HR = @ , @ % CI = @-@ @ ) on multivariable analysis .


A MVC within the previous @ years ( HR = @ , @ % CI = @-@ @ ) was the strongest predictor of future MVCs .


Other clinical factors associated with greater MVC risk were depression , falls within the previous year , sleep apnea , and lower baseline systolic blood pressure .


In a population of frequent drivers , the MMSE does not predict MVCs .


Other clinical factors have a stronger association with MVC risk .


Primary dysmenorrhea refers to painful menstrual cramps without pelvic pathology .


The condition is highly prevalent among women and exerts negative effects on their quality of life .


Considering the evidence for anti-inflammatory properties of Boron , the present study aimed to determine the effects of Boron supplementation on the severity and duration of menstrual pain in female university students .


This triple-blind randomized clinical trial study recruited @ university students .


The participants were matched for the severity and duration of dysmenorrhea and randomly allocated into the case and control groups ( n = @ and @ , respectively ) .


The case group consumed @ mg/day Boron from two days before the menstrual flow until its third day .


The control group received placebo capsules ( similar to those distributed among the cases ) .


All subjects were asked to take the capsules for two consecutive menstrual cycles .


Pain severity ( measured on a visual analog scale ) and duration ( in hours ) were measured at baseline and during the two cycles .


The two groups had no significant differences in the severity and duration of pain at baseline .


After the intervention , however , the severity and duration of pain were significantly lower in the case group than in the control group ( P < @ ) .


Based on our findings , Boron supplementation can reduce the severity and duration of menstrual pain through exerting anti-inflammatory effects .


In order to clarify the effects of Boron on dysmenorrhea , future studies are required to measure the levels of hormones and inflammatory biomarkers .


The present study examined the impact of BP from childhood to mid-adulthood on retinal microvascular architecture .


The Cardiovascular Risk in Young Finns Study included children aged @-@ years , from five Finnish University cities , with participants chosen randomly from the national population registrar from those areas .


The age of participants included in the current analyses in childhood ( @ ) ranged from three to nine years and in mid-adulthood ( @ ) ranged from @ to @ years ( complete data n = @ ) .


Measures of retinal microvasculature architecture measured in adulthood included diameters , tortuosity , lengths , and LDR .


Regression analysis showed a strong negative association between childhood systolic BP and adult arteriolar diameter ( standardized regression coefficient -LSB- -RSB- -@ ; p < @ ) and with change in systolic BP from childhood to adulthood ( = -@ ; p < @ ) .


For arteriolar tortuosity , there was a strong positive association between childhood systolic BP and adult arteriolar tortuosity ( = @ ; p < @ ) and no association with change in systolic BP from childhood to adulthood ( = @ ; p = @ ) .


High BP in childhood and increased BP from childhood to adulthood impacts on retinal microvascular architecture in mid-adulthood .


To evaluate quantitative relationships between baseline Q-wave width and @-day outcomes in ST-segment elevation myocardial infarction ( STEMI ) .


Baseline Q-waves are useful in predicting clinical outcomes after MI .


@ STEMI patients were assessed from a multi-centre study .


@ patients of the overall cohort had pathologic Q-waves .


The @-day mortality and the composite of mortality , congestive heart failure ( CHF ) , or cardiogenic shock ( p < @ for both outcomes ) rose as Q-wave width increased .


After adapting a threshold @ms for inferior and @ms for lateral/apical MI in all patients ( n = @ ) with any measureable Q-wave we found hazard ratios ( HR ) for mortality ( HR : @ , @ % confidence interval ( CI ) ( @-@ @ ) , p < @ ) and the composite ( HR : @ , @ % CI ( @-@ @ ) , p < @ ) .


This improved reclassification of patients experiencing the composite endpoint versus the conventional definition ( net reclassification index ( NRI ) : @ , @ % CI ( @-@ @ ) , p < @ ) and universal MI definition ( NRI : @ , @ % CI ( @-@ @ ) , p = @ ) .


The width of the baseline Q-wave in STEMI adds prognostic value in predicting @-day clinical outcomes .


A threshold of @ms in inferior and @ms for lateral/apical MI enhances prognostic insight beyond current criteria .


The relationship between current asthma symptoms and rescue bronchodilator ( reliever ) use is uncertain , leading to different recommendations about the preferred reliever metric to use when assessing asthma control .


In a @-month randomized controlled trial of combination budesonide/formoterol as maintenance and reliever therapy versus combination budesonide/formoterol as maintenance treatment with albuterol as reliever , we measured inhaler use by electronic monitoring .


To determine the agreement between current asthma symptoms and different metrics of albuterol use for patients randomly assigned to maintenance budesonide/formoterol treatment .


Data on albuterol use were extracted for the @-day period before visit @ ( at week @ ) from @ adult patients with asthma .


Current asthma symptoms were measured by Asthma Control Questionnaire-@ ( ACQ-@ ) score at the clinic visit .


The number of days of albuterol use , the average number of albuterol actuations/day , and the highest number of albuterol actuations/day in the @-week period were all positively associated with ACQ-@ score ( r = @-@ @ , P < @ ) and had moderate discrimination for well-controlled and not well-controlled asthma ( ACQ-@ scores @ and @ , respectively ) , with receiver operator characteristic area under the curve of @ to @ and @ to @ , respectively .


Cut points of @ days of albuterol use , average albuterol use of @ actuation/day , and highest albuterol use of @ actuations/day in the @-week period had @ % sensitivity and @ % specificity , @ % sensitivity and @ % specificity , and @ % sensitivity and @ % specificity , respectively , for predicting an ACQ-@ @ .


Our findings support the use of the number of days of albuterol use , the average number of albuterol actuations per day , and the highest number of albuterol actuations per day over a @-week period of observation as comparable markers of current asthma control .


Tenofovir has been associated with a decrease in bone mineral density ( BMD ) .


However , data on changes in BMD after discontinuing tenofovir are lacking .


We performed a two-centre randomized pilot study in virologically suppressed HIV-infected patients receiving tenofovir with osteopenia/osteoporosis ( OsteoTDF study , ClinicalTrials.gov number NCT @ ) .


Fifty-four patients were randomly assigned to switch from tenofovir to abacavir ( n = @ ) or to continue with tenofovir ( n = @ ) .


Changes in lumbar and total hip BMD were evaluated at Week @ from baseline .


Five patients discontinued the study ( three from the tenofovir group and two from the abacavir group ) .


No significant differences were detected between the groups at Week @ ( P = @ for total hip and P = @ for lumbar spine ) .


However , hip BMD improved by @ % ( @ % CI -@ to @ ) ( P = @ ) in the abacavir group and @ % ( @ % CI -@ to @ ) ( P = @ ) in the tenofovir group .


Lumbar spine BMD varied by -@ % ( @ % CI -@ to @ ) ( P @ ) in the abacavir group and -@ % ( @ % CI -@ to @ ) ( P < @ ) in the tenofovir group .


Switching from tenofovir to abacavir led to a slight improvement in femoral BMD although no differences were detected between groups .


Larger studies are necessary before firm recommendations can be made on the discontinuation of tenofovir in patients with a low BMD .


Binaural interaction can be investigated using auditory evoked potentials .


A binaural interaction component can be derived from the auditory brainstem response ( ABR-BIC ) and is considered evidence for binaural interaction at the level of the brainstem .


Although click ABR-BIC has been investigated thoroughly , data on @ Hz tone-burst ( TB ) ABR-BICs are scarce .


In this study , characteristics of click and @ Hz TB ABR-BICs are described .


Furthermore , reliability of both click and @ Hz TB ABR-BIC are investigated .


Eighteen normal hearing young adults ( eight women , ten men ) were included .


ABRs were recorded in response to clicks and @ Hz TBs .


ABR-BICs were derived by subtracting the binaural response from the sum of the monaural responses measured in opposite ears .


Good inter-rater reliability is obtained for both click and @ Hz TB ABR-BICs .


The most reliable peak in click ABR-BIC occurs at a mean latency of @ ms ( SD @ ms ) .


Reliable @ Hz TB ABR-BIC are obtained with a mean latency of @ ms ( SD @ ms ) .


Amplitudes are larger for @ Hz TB ABR-BIC than for clicks .


The most reliable peak in click ABR-BIC occurs at the downslope of wave V. Five hundred Hertz TB ABR-BIC is characterized by a broad positivity occurring at the level of wave V.


The ABR-BIC is a useful technique to investigate binaural interaction in certain populations .


Examples are bilateral hearing aid users , bilateral cochlear implant users and bimodal listeners .


The latter refers to the combination of unilateral cochlear implantation and contralateral residual hearing .


The majority of these patients have residual hearing in the low frequencies .


The current study suggests that @ Hz TB ABR-BIC may be a suitable technique to assess binaural interaction in this specific population of cochlear implant users .


To evaluate the possible association between pressure pain sensitivity of the chest bone ( PPS ) and cardiovascular physiological factors related to persistent stress in connection with a three-month PPS-guided stress-reducing experimental intervention programme .


Forty-two office workers with an elevated PPS ( @ arbitrary units ) as a sign of increased level of persistent stress , completed a single-blinded cluster randomized controlled trial .


The active treatment was a PPS ( self-measurement ) - guided stress management programme .


Primary endpoints : Blood pressure ( BP ) , heart rate ( HR ) and work of the heart measured as Pressure-Rate-Product ( PRP ) ; Secondary endpoints : Other features of the metabolic syndrome .


PPS decreased and changes in PPS after the intervention period were significantly associated with HR , PRP , body mass index ( BMI ) and visceral fat index ( all correlation coefficients > @ , p < @ ) .


Compared to the control cluster group , the active cluster group obtained a significant reduction in PPS , Low-density lipoprotein ( LDL ) cholesterol and total number of elevated risk factors ( p < @ ) .


On an individual level , significant and clinically relevant between-group reductions were observed in respect to BP , HR , PRP , total and LDL cholesterol , and total number of elevated risk factors ( p < @ ) .


The stress intervention method applied in this study induced a decrease in PPS which was associated with a clinically relevant decrease in resting blood pressure , heart rate , work of the heart and serum cholesterols .


The low quality of healthcare and the presence of user fees in Burkina Faso contribute to low utilization of healthcare and elevated levels of mortality .


To improve access to high-quality healthcare and equity , national authorities are testing different intervention arms that combine performance-based financing with community-based health insurance and pro-poor targeting .


There is a need to evaluate the implementation of these unique approaches .


We developed a research protocol to analyze the conditions that led to the emergence of these intervention arms , the fidelity between the activities initially planned and those conducted , the implementation and adaptation processes , the sustainability of the interventions , the possibilities for scaling them up , and their ethical implications .


The study adopts a longitudinal multiple case study design with several embedded levels of analyses .


To represent the diversity of contexts where the intervention arms are carried out , we will select three districts .


Within districts , we will select both primary healthcare centers ( n = @ ) representing different intervention arms and the district or regional hospital ( n = @ ) .


We will select contrasted cases in relation to their initial performance ( good , fair , poor ) .


Over a period of @ months , we will use quantitative and qualitative data collection and analytical tools to study these cases including in-depth interviews , participatory observation , research diaries , and questionnaires .


We will give more weight to qualitative methods compared to quantitative methods .


Performance-based financing is expanding rapidly across low - and middle-income countries .


The results of this study will enable researchers and decision makers to gain a better understanding of the factors that can influence the implementation and the sustainability of complex interventions aiming to increase healthcare quality as well as equity .


Obesity is a major public health problem for which early preventive interventions are needed .


Large numbers of young children are enrolled in some form of child care program , making these facilities influential environments in children 's development .


Family child care homes ( FCCH ) are a specific type of child care in which children are cared for within the provider 's own residence .


FCCHs serve approximately @ million children in the U.S. ; however , research to date has overlooked FCCH providers and their potential to positively influence children 's health-related behaviors .


Keys to Healthy Family Child Care Homes ( Keys ) is a cluster-randomized controlled trial testing the efficacy of an intervention designed to help providers become healthy role models , provide quality food - and physical activity-supportive FCCH environments , and implement effective business practices .


The intervention is delivered through workshops , home visits , tailored coaching calls , and educational toolkits .


Primary outcomes are child physical activity measured via accelerometry data and dietary intake data collected using direct observation at the FCCH .


Secondary outcomes include child body mass index , provider weight-related behaviors , and observed obesogenic environmental characteristics .


Keys is an innovative approach to promoting healthy eating and physical activity in young children .


The intervention operates in a novel setting , targets children during a key developmental period , and addresses both provider and child behaviors to synergistically promote health .


Benign essential blepharospasm ( BEB ) is characterized by progressive involuntary contractions of the protractor muscles , sometimes leading to a debilitating closure of the lids .


It is currently treated with the injection of botulinum neurotoxin A ( BoNT/A ) .


The purpose of this study was to compare @ BoNT/A preparations ( i.e. , Xeomin and Botox ) in the treatment of BEB .


This was a prospective , randomized , double-blinded split-face technique in @ patients already treated by Botox for BEB .


Patients received the same medication to either side of the face for @ injections , and were then evaluated using subjective and objective measures .


Blepharospasm Disability Index ( BSDI ) and Jankovic Rating Scale ( JRS ) were assessed using a repeated-measures analysis of variance ( ANOVA ) and paired t test .


Patient preference and objective comparison of residual orbicularis strength and spasm were compared using a multinomial logistic regression model , a repeated-measures ANOVA , and a paired t test .


A paired t test showed no preference between Xeomin and Botox ( P = @ ) and demonstrated a tendency toward not having a preference for either medication ( P = @ vs Botox and P = @ vs Xeomin ) .


The regression model showed no effect of time on patient preference ( P = @ ) .


The ANOVA for BSDI scores did not reveal any difference between the @ medications as compared with baseline ( P = @ ) , nor did it demonstrate an effect of time on BSDI scores ( P = @ ) .


A paired t test found no difference between the @ scores ( P = @ ) at baseline .


There was no difference in JRS scores for either medication when compared with baseline ( P = @ ) , nor was there an effect of time on such scores ( P = @ ) .


There was also no difference between the @ medications according to paired t test ( P = @ ) at baseline .


Baseline residual orbicularis strength was similar between the @ medications ( paired t test ; P = @ ) .


ANOVA shows an effect of time on orbicularis strength ( P = @ ) , but no difference was seen at any of the @ visits ( P > @ ) .


Baseline spasm scores were similar between Botox and Xeomin ( paired Student t test ; P = @ ) .


The ANOVA shows no difference between both medications at any point in time ( P = @ ) , and that time had no effect on the efficacy of either treatment ( P = @ ) .


No difference between Xeomin and Botox was detected in either subjective or objective measures for the treatment of BEB .


Co-morbid depression in HIV-positive patients on anti-retroviral ( ART ) treatment poses a public health threat .


It compromises treatment adherence and accelerates disease progression .


This study aimed to assess the feasibility of a group-based counselling intervention for depressed HIV-positive patients in primary health care ( PHC ) in South Africa using a task shifting approach .


Using a randomized control design , @ HIV-positive patients with co-morbid depression were initially recruited .


This reduced to @ in the final cohort .


Participants were assessed using the Patient Health Questionnaire ( PHQ@ ) , Hopkins Symptom Checklist ( HSCL-@ ) and Multidimensional Scale of Perceived Social Support ( MSPSS ) at baseline and @-month follow-up .


The intervention was adapted from a local group-based Interpersonal Therapy ( IPT ) intervention .


Process evaluation interviews were held with the HIV counsellors who delivered the intervention and a sub-sample of participants .


Repeated measures ANOVA analysis showed significantly greater improvement on depression scores on the PHQ@ in the intervention group compared to the control group .


A significant decline in the mean scores on the HSCL-@ was found for both groups although this was more pronounced for the intervention group .


There was no significant improvement in the MSPSS scores .


The small sample size of the final cohort affected the power of the study to detect significant differences between the intervention and control groups on the MSPSS .


Longer term impact of the intervention is unknown .


These preliminary findings suggest that group-based counselling for depression in HIV-positive patients can potentially be effectively delivered by appropriately trained and supported lay HIV counsellors .


The need for a larger trial is indicated .


To evaluate antinociceptive effects and pharmacokinetics of butorphanol tartrate after IM administration to American kestrels ( Falco sparverius ) .


Fifteen @ - to @-year-old American kestrels ( @ males and @ females ) .


Butorphanol ( @ , @ , and @ mg/kg ) and saline ( @ % NaCl ) solution were administered IM to birds in a crossover experimental design .


Agitation-sedation scores and foot withdrawal response to a thermal stimulus were determined @ to @ minutes before ( baseline ) and @ , @ , @ , and @ hours after treatment .


For the pharmacokinetic analysis , butorphanol ( @ mg/kg , IM ) was administered in the pectoral muscles of each of @ birds .


In male kestrels , butorphanol did not significantly increase thermal thresholds for foot withdrawal , compared with results for saline solution administration .


However , at @ hours after administration of @ mg of butorphanol/kg , the thermal threshold was significantly decreased , compared with the baseline value .


Foot withdrawal threshold for female kestrels after butorphanol administration did not differ significantly from that after saline solution administration .


However , compared with the baseline value , withdrawal threshold was significantly increased for @ mg/kg at @ and @ hours , @ mg/kg at @ hours , and @ mg/kg at @ hours .


There were no significant differences in mean sedation-agitation scores , except for males at @ hours after administration of @ mg/kg .


Butorphanol did not cause thermal antinociception suggestive of analgesia in American kestrels .


Sex-dependent responses were identified .


Further studies are needed to evaluate the analgesic effects of butorphanol in raptors .


To evaluate the efficacy and safety of dapagliflozin in patients with type @ diabetes inadequately controlled with metformin and sulfonylurea .


Patients with HbA@c of @ % ( @ mmol/mol ) to @ % ( @ mmol/mol ) receiving sulfonylurea and metformin were randomized to receive dapagliflozin @ mg/day ( n = @ ) or placebo ( n = @ ) for @ weeks .


HbA@c ( baseline : dapagliflozin @ % -LSB- @ mmol/mol -RSB- ; placebo @ % -LSB- @ mmol/mol -RSB- ) and fasting plasma glucose ( baseline : dapagliflozin @ mg/dL -LSB- @ mmol/L -RSB- ; placebo @ mg/dL -LSB- @ mmol/L -RSB- ) significantly improved from baseline with dapagliflozin ( placebo-subtracted change -@ % -LSB- -@ mmol/mol -RSB- , P < @ ; -@ mg/dL -LSB- -@ mmol/L -RSB- , P < @ , respectively ) .


More patients achieved a therapeutic glycemic response ( HbA@c < @ % -LSB- @ mmol/mol -RSB- ) with dapagliflozin ( @ % ) versus placebo ( @ % ) ( P < @ ) .


Body weight and systolic blood pressure were significantly reduced from baseline over @ and @ weeks , respectively , with dapagliflozin ( placebo-subtracted change -@ kg , P < @ ; -@ mmHg , P = @ ) .


Patients receiving dapagliflozin showed placebo-subtracted increases in total , LDL , and HDL cholesterol ( @ mg/dL , P = @ ; @ mg/dL , P = @ ; @ mg/dL , P = @ , respectively ) with no change in LDL/HDL cholesterol ratio ( @ ; P = @ ) or triglycerides ( -@ mg/dL ; P = @ ) .


Adverse events occurred in @ % of patients receiving dapagliflozin and @ % receiving placebo .


Significantly more patients with dapagliflozin compared with placebo experienced hypoglycemia ( @ vs. @ % ; P = @ ) and genital infections ( @ vs. @ % ; P = @ ) .


Events of urinary tract infection were reported by @ % of patients in both groups .


Dapagliflozin was well tolerated and effective over @ weeks as add-on to metformin plus sulfonylurea .


Adverse effects included hypoglycemia and genital infections .


Patients treated with radiation therapy for laryngeal cancer often experience voice problems .


The aim of this randomized controlled trial was to assess the efficacy of voice rehabilitation for laryngeal cancer patients after having undergone radiation therapy and to investigate whether differences between different tumor localizations with regard to rehabilitation outcomes exist .


Sixty-nine male patients irradiated for laryngeal cancer participated .


Voice recordings and self-assessments of communicative dysfunction were performed @ and @ months after radiation therapy .


Thirty-three patients were randomized to structured voice rehabilitation with a speech-language pathologist and @ to a control group .


Furthermore , comparisons with @ healthy control individuals were made .


Acoustic analyses were performed for all patients , including the healthy control individuals .


The Swedish version of the Self Evaluation of Communication Experiences after Laryngeal Cancer and self-ratings of voice function were used to assess vocal and communicative function .


The patients who received vocal rehabilitation experienced improved self-rated vocal function after rehabilitation .


Patients with supraglottic tumors who received voice rehabilitation had statistically significant improvements in voice quality and self-rated vocal function , whereas the control group did not .


Voice rehabilitation for male patients with laryngeal cancer is efficacious regarding patient-reported outcome measurements .


The patients experienced better voice function after rehabilitation .


Patients with supraglottic tumors also showed an improvement in terms of acoustic voice outcomes .


Rehabilitation with a speech-language pathologist is recommended for laryngeal cancer patients after radiation therapy , particularly for patients with supraglottic tumors .


Antireflux therapy may lead to recovery of impaired mucosal integrity in gastro-esophageal reflux disease ( GERD ) patients as reflected by an increase in baseline impedance .


The study objective was to evaluate the effect of endoscopic fundoplication and proton pump inhibitor ( PPI ) PPI therapy on baseline impedance and heartburn severity in GERD patients .


Forty-seven GERD patients randomized to endoscopic fundoplication ( n = @ ) or PPI therapy ( n = @ ) , and @ healthy controls were included .


Before randomization and @months after treatment , baseline impedance was obtained during @-h pH-impedance monitoring .


Heartburn severity was evaluated using the GERD-HRQL questionnaire .


Before treatment , baseline impedance in GERD patients was lower than in healthy controls ( p < @ ) .


Antireflux therapy increased baseline impedance ( from @ -LSB- IQR @-@ -RSB- to @ -LSB- IQR @-@ -RSB- , p = @ ) , however it only led to a partial recovery when compared to healthy controls ( @ -LSB- IQR @-@ -RSB- vs @ -LSB- @-@ -RSB- , p < @ ) .


The effect of both treatment options was not significantly different ( p = @ ) despite the increased number of non-acid reflux events in the PPI group .


No correlation was found between baseline impedance and GERD symptoms before or after treatment .


Reduction in acid reflux by endoscopic fundoplication or PPI therapy leads to an increase in baseline impedance in GERD patients , likely to reflect recovery of mucosal integrity .


The impact of non-acid reflux events on esophageal mucosal integrity may be limited as no difference in the increase in baseline impedance was observed after both treatment options .


The lack of association between impedance baseline and heartburn severity indicates that other factors may contribute to heartburn perception in GERD .


Nitrate supplementation improves endurance exercise and single bouts of high-intensity activity , but its effect on repeated sprints is unclear .


This study is the first to investigate the effects of acute dietary nitrate supplementation during a high-intensity intermittent-sprint test to exhaustion .


Team-sport athletes ( @ male , age @ @ y , VO@max @ @ mL kg-@ min-@ ; @ female , age @ @ y , VO@max @ @ mL kg-@ min-@ ) were assigned to a double-blind , randomized , crossover design .


Participants consumed @ mL of concentrated beetroot juice containing a minimum of @ g of nitrate ( NT ) or @ mL of placebo ( PL ) @ h before a repeated-sprint protocol involving repeated @-s sprints with @-s recovery on a cycle ergometer to exhaustion .


Fewer sprints ( NT = @ @ vs PL = @ @ , P = @ , d = @ ) and less total work ( NT = @ @ kJ vs PL = @ @ kJ , P = @ , d = @ ) were completed in NT relative to PL .


However there was no difference in overall mean power output or the mean power output for each individual @-s sprint .


These findings suggest that dietary nitrate is not beneficial for improving repeated-sprint performance , at least when such sprints are near-maximal and frequent in nature .


The lack of an effect of nitrate at near-maximal oxygen uptake supports the suggestion that at greater exercise intensities nitrate does not have an ergogenic effect .


Abelmoschus manihot , a single medicament of traditional Chinese medicine , has been widely used to treat kidney disease .


This is the first randomized controlled clinical trial to assess its efficacy and safety in patients with primary glomerular disease .


Prospective , open-label , multicenter , randomized , controlled , clinical trial .


From May @ to October @ , a total of @ patients with biopsy-proven primary glomerular disease from @ hospitals participated in the study .


A manihot in the form of a huangkui capsule , @ g , @ times per day ; losartan potassium , @mg/d ; or combined treatment , a huangkui capsule at @ g @ times per day , was combined with losartan potassium , @mg/d .


The duration of intervention was @ weeks .


The primary outcome was change in @-hour proteinuria from baseline after treatment .


Change in estimated glomerular filtration rate ( eGFR ) from baseline after treatment was a secondary outcome .


The @-hour proteinuria was measured every @ weeks and eGFR was measured at @ , @ , @ , and @ weeks .


Mean baseline urine protein excretion was @,@ , @,@ , and @,@ mg/d in the A manihot , losartan , and combined groups , respectively , and mean eGFR was @ , @ , and @ mL/min/@ @ m@ , respectively .


After @ weeks of treatment , mean changes in proteinuria were protein excretion of -@ , -@ , and -@ mg/d , respectively ( P = @ for A manihot vs losartan and P < @ for the combined treatment vs losartan ) .


Mean eGFR did not change significantly .


The incidence of adverse reactions was not different among the @ groups ( P > @ ) , and there were no severe adverse events in any group .


Results can not be generalized to those with nephrotic syndrome or reduced eGFR .


A manihot is a promising therapy for patients with primary kidney disease ( chronic kidney disease stages @-@ ) with moderate proteinuria .


To prospectively evaluate the neuropsychological effect of levetiracetam ( LVT ) in comparison with carbamazepine ( CBZ ) and its efficacy and tolerability as a monotherapy in children with focal epilepsy .


A total of @ out of @ screened children ( @-@ years ) were randomly assigned to LVT or CBZ groups in a multicenter , parallel-group , open-label trial .


The study 's primary endpoints were defined as the end of @ weeks of treatment , followed by analysis of changes observed in a series of follow-up neurocognitive , behavioral , and emotional function tests performed during treatment in the per protocol population .


Drug efficacy and tolerability were also analyzed among the intention-to-treat ( ITT ) population ( ClinicalTrials.gov , number NCT@ ) .


Eighty-one patients ( @ LVT , @ CBZ ) from the randomly assigned ITT population of @ children ( @ LVT , @ CBZ ) were followed up to their last visit .


No significant worsening or differences were noted between groups in neuropsychological tests , except for the Children 's Depression Inventory ( LVT -@ vs CBZ +@ , p = @ , -LSB- + -RSB- improvement of function ) .


LVT-treated patients showed an improvement ( p = @ ) in internalizing behavioral problems on the Korean Child Behavior Checklist .


Seizure-free outcomes were not different between the @ groups ( CBZ @ % vs LVT @ % , p = @ ) .


Neither LVT nor CBZ adversely affected neuropsychological function in pediatric patients .


Both medications were considered equally safe and effective as monotherapy in children with focal epilepsy .


This study provides Class II evidence that in patients with pediatric focal epilepsy , LVT and CBZ exhibit equivalent effects on neuropsychological function .


To compare the efficacy of @ prophylaxis regimens before cataract surgery using topical antibiotics ( @ hour before surgery versus the day before ) , both with povidone-iodine , with regard to reducing the preoperative conjunctival bacterial load .


Tertiary ophthalmic referral center , Munich , Germany .


Prospective comparative case series .


Eyes were treated with topical antibiotics and their conjunctival sac flush irrigated using @ mL of povidone-iodine @ % .


All eyes were randomized to receive either @ applications of topical @ IU/mL neomycin sulfate/@ IU/mL polymyxin-B sulfate within @ hour preoperatively ( Group @ ) or on the day before surgery ( Group @ ) .


Conjunctival specimens were obtained at @ timepoints : T@C untreated fellow eye ( control ) , T@ surgery eye ( after antibiotic prophylaxis but before povidone-iodine irrigation ) , T@ after povidone-iodine , and T@ at the conclusion of surgery .


All specimens were inoculated onto blood and chocolate-blood agar and into thioglycollate broth .


One hundred thirty-three eyes of @ consecutive patients were included ( Group @ , @ eyes ; Group @ , @ eyes ) .


The antibiotic regimens were equally effective in reducing the aerobic and microaerophilic conjunctival flora ( Group @ , P = @ ; Group @ , P = @ ) , but had no significant effect on anaerobic bacteria ( Group @ , P = @ ; Group @ , P = @ ) .


Flush irrigation of the conjunctival sac using @ mL povidone-iodine @ % significantly decreased the conjunctival bacterial load in both groups .


Topical neomycin/polymyxin-B was equally effective in reducing the conjunctival bacterial load whether given @ day or @ hour before surgery .


The greatest effect was achieved by irrigating the conjunctival sac using povidone-iodine .


Assessment is a critical component of therapeutic intervention as it serves as the basis from which clinical goals and objectives are derived .


Unfortunately , there is a dearth of reliable group therapy assessment instruments , especially for children and preadolescents who have severe emotional disturbances .


The purpose of this study was to test reliability of a newly developed group therapy assessment instrument for use with children who have serious emotional disturbances that require placement in a residential or partial hospitalization treatment program .


After conducting an extensive literature review , the authors developed , refined , and tested a group therapy assessment tool for use in both music therapy and traditional therapy , measuring nine items : attention to task ( physical and verbal ) , eye contact , pro-social skills ( physical and verbal ) , empathy ( physical and verbal ) , and managing negative affect ( physical and verbal ) .


Six participants with a mean age of @ ( SD = @ ) years were randomly selected to test the group therapy assessment tool from a pool of @ eligible children receiving group partial hospitalization therapy .


Participants were scored by three raters across two partial hospitalization therapy groups for inter-rater reliability .


Content and construct validity were also examined .


Intraclass Coefficients ( ICC ) averaged @ across all nine items indicating excellent inter-rater reliability .


Content and construct validity was established and the instrument demonstrated good external validity potential .


The Beech Brook Therapy Assessment Instrument has demonstrated excellent inter-rater reliability in measuring important behaviors of functioning central in the treatment of youth with severe and emotional disturbances .


The measure has potential for wide utility and application in practice and research ; however , future studies are needed to establish external validity .


Breakthrough cancer pain typically has a rapid onset and relatively short duration .


Due to this temporal profile , it may not be adequately relieved by oral opioid analgesics .


The sublingual fentanyl orally disintegrating tablet is a formulation by which fentanyl can be rapidly absorbed across the oral mucosa producing rapid-onset analgesia , and which may be effective for breakthrough pain treatment .


A multicenter , randomized , placebo-controlled , double-blind comparative study was conducted to evaluate the efficacy and safety of the sublingual fentanyl tablet at optimized doses for breakthrough pain treatment in cancer patients treated with strong opioid analgesics at fixed intervals .


The optimal dose was determined by open-label dose titration .


The efficacy and safety of a @-week extended treatment were also evaluated .


Eleven of @ subjects who received the sublingual fentanyl tablet experienced adverse drug reactions .


Common reactions were somnolence , constipation , nausea , and vomiting .


No serious adverse reactions occurred .


Sublingual fentanyl tablets at optimal doses and placebo were administered to @ subjects in a double-blinded manner .


A significant analgesic effect of the sublingual fentanyl tablet was present compared to placebo at @ min after administration .


The sublingual fentanyl tablet was also effective and safe during extended treatment , in which changes in basal opioid doses as well as sublingual fentanyl tablet doses were made as needed .


Sublingual fentanyl tablets at doses determined by titration were effective and safe for breakthrough pain treatment in cancer patients treated with strong opioid analgesics at fixed intervals .


Extended treatment up to @ weeks was also effective and safe .


Extensive decompression with laminectomy , where appropriate , is often still described as the method of choice when operating on degenerative lumbar spinal stenosis .


Nonetheless , tissue-sparing procedures are becoming more common .


Endoscopic techniques have become the standard in many areas because of the surgical advantages they offer and the benefits for rehabilitation .


One key issue when operating on the spine was the development of instruments to provide sufficient bone resection under continuous visual control .


This was achieved by using endoscopes for operations carried out in cases of spinal canal stenosis .


This study of patients with degenerative lumbar central spinal stenosis compares the results of spinal decompression using the full-endoscopic interlaminar technique ( FI ) with a conventional microsurgical laminotomy technique ( MI ) .


Prospective , randomized , controlled study .


@ patients with microsurgical or full-endoscopic decompression were followed up for @ years .


Alongside general and specific parameters , the following measuring instruments were also used for the investigation : Visual Analog Scale ( VAS ) , German version of the North American Spine Society Instrument ( NASS ) , Oswestry Low-Back-Pain-Disability Questionnaire ( ODI ) .


Postoperatively @ % of the patients no longer had leg pain or the pain was almost completely reduced and @ % experienced occasional pain .


The clinical results were the same in both groups .


The rate of complications and revisions was significantly reduced in the FI Group .


The full-endoscopic techniques brought advantages in the following areas : operation , complications , traumatization , rehabilitation .


Lack of placebo control group .


The recorded results demonstrate that the full-endoscopic interlaminar bilateral decompression adopting a unilateral approach provides an adequate and safe supplement and alternative to the conventional microsurgical bilateral laminotomy technique when the indication criteria are fulfilled .


At the same time , it offers the advantages of a minimally invasive intervention .


The doctor-patient encounter ( DPE ) and associated patient expectations are potential confounders in open-label randomized trials of treatment efficacy .


It is therefore important to evaluate the effects of the DPE on study outcomes .


Four hundred participants with chronic low back pain ( LBP ) were randomized to four dose groups : @ , @ , @ , or @ sessions of spinal manipulation from a chiropractor .


Participants were treated three times per week for six weeks .


They received light massage control at visits when manipulation was not scheduled .


Treating chiropractors were instructed to have equal enthusiasm for both interventions .


A path analysis was conducted to determine the effects of dose , patient expectations of treatment success , and DPE on LBP intensity ( @-point scale ) at the end of care ( @ weeks ) and primary endpoint ( @ weeks ) .


Direct , indirect , and total standardized effects ( total ) were computed .


Expectations and DPE were evaluated on Likert scales .


The DPE was assessed as patient-rated perception of chiropractor enthusiasm , confidence , comfort with care , and time spent .


The DPE was successfully balanced across groups , as were baseline expectations .


The principal finding was that the magnitude of the effects of DPE on LBP at @ and @ weeks ( | | total = @ and @ , p < @ ) were comparable to the effects of dose of manipulation at those times ( | | total = @ and @ , p < @ ) .


In addition , baseline expectations had no notable effect on follow-up LBP .


Subsequent expectations were affected by LBP , DPE , and dose ( p < @ ) .


The DPE can have a relatively important effect on outcomes in open-label randomized trials of treatment efficacy .


Therefore , attempts should be made to balance the DPE across treatment groups and report degree of success in study publications .


We balanced the DPE across groups with minimal training of treatment providers .


To identify risk factors for failure of anticoagulant thromboprophylaxis in critically ill patients in the ICU .


Multivariable regression analysis of thrombosis predictors from a randomized thromboprophylaxis trial .


Sixty-seven medical-surgical ICUs in six countries .


Three thousand seven hundred forty-six medical-surgical critically ill patients .


All patients received anticoagulant thromboprophylaxis with low-molecular-weight heparin or unfractionated heparin at standard doses .


Independent predictors for venous thromboembolism , proximal leg deep vein thrombosis , and pulmonary embolism developing during critical illness were assessed .


A total of @ patients ( @ % ) developed venous thromboembolism .


Predictors of thromboprophylaxis failure as measured by development of venous thromboembolism included a personal or family history of venous thromboembolism ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) and body mass index ( hazard ratio , @ per @-point increase ; @ % CI , @-@ @ ; p = @ ) .


Increasing body mass index was also a predictor for developing proximal leg deep vein thrombosis ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) , which occurred in @ patients ( @ % ) .


Pulmonary embolism occurred in @ patients ( @ % ) and was associated with body mass index ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) and vasopressor use ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) .


Low-molecular-weight heparin ( in comparison to unfractionated heparin ) thromboprophylaxis lowered pulmonary embolism risk ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) while statin use in the preceding week lowered the risk of proximal leg deep vein thrombosis ( hazard ratio , @ ; @ % CI , @-@ @ ; p = @ ) .


Failure of standard thromboprophylaxis using low-molecular-weight heparin or unfractionated heparin is more likely in ICU patients with elevated body mass index , those with a personal or family history of venous thromboembolism , and those receiving vasopressors .


Alternate management or incremental risk reduction strategies may be needed in such patients .


We conducted this pilot randomized clinical trial to determine the feasibility of a large clinical trial aimed at testing whether early use of catheter ablation of ventricular tachycardia ( VT ) is superior to antiarrhythmic medications at reducing mortality .


Patients were enrolled at @ sites if they had ischemic heart disease , an implantable cardioverter defibrillator ( ICD ) , and received @ ICD shock or @ antitachycardia pacing therapies for VT. .


Patients were randomized to @ arms : ( @ ) antiarrhythmic medication ( n = @ ) and ( @ ) catheter ablation ( n = @ ) ; patients were followed at @ and @ months .


Endpoints included recurrent VT , time to first ICD therapy for VT , and death .


Of @ screened patients , @ were enrolled .


Main reasons for screen failures were : ( @ ) patient was already on an antiarrhythmic medication ( @ -LSB- @ % -RSB- ) , ( @ ) VT due to a reversible cause ( @ -LSB- @ % -RSB- ) , and ( @ ) incessant VT ( @ -LSB- @ % -RSB- ) .


Fourteen patients had recurrent VT , @ ( @ % ) in the ablation arm and @ ( @ % ) in the antiarrhythmic medication arm .


Median time to recurrent VT was @ days ( @th , @th : @ , @ ) in the ablation arm and @ days ( @ , @ ) in the antiarrhythmic arm .


Four patients died , @ in each arm .


This clinical trial shows that most patients in clinical practice have already failed antiarrhythmic drug therapy before catheter ablation is considered , and the VT recurrence rates and death in these patients are high .


For a large clinical trial to be feasible , factors limiting early consideration of catheter ablation need to be identified and addressed .


Anxiety , Depression and Somatoform ( ADSom ) disorders are highly prevalent in primary care .


Managing these disorders is time-consuming and requires strong commitment on behalf of the General Practitioners ( GPs ) .


Furthermore , the management of these patients is restricted by the high patient turnover rates in primary care practices , especially in the German health care system.In order to address this problem , we implement a complex , low-threshold intervention by an Advanced Practice Nurse ( APN ) using a mixture of case management and counseling techniques to promote self-management in these patients .


Here we present the protocol of the `` Self-Management Support for Anxiety , Depression and Somatoform Disorders in Primary Care '' ( SMADS ) - Study .


The study is designed as a cluster-randomized controlled trial , comparing an intervention and a control group of @ primary care practices in each case .


We will compare the effectiveness of the intervention applied by an APN with usual GP-care .


A total of @ participants will be enrolled in the study , @ in either arm .


We use the Patient Health Questionnaire-German version ( PHQ-D ) as a screening tool for psychiatric symptoms , including patients with a score above @ on any of the three symptom scales .


The primary outcome is self-efficacy , measured by the General Self-Efficacy Scale ( GSE ) , here used as a proxy for self-management .


As secondary outcomes we include the PHQ-D symptom load and questionnaires regarding coping with illness and health related quality of life .


Outcome assessments will be applied @ weeks and @ months after the baseline assessment .


The SMADS-study evaluates a complex , low threshold intervention for ambulatory patients presenting ADSom-symptoms , empowering them to better manage their condition , as well as improving their motivation to engage in self-help and health-seeking behaviour .


The benefit of the intervention will be substantiated , when patients can enhance their expected self-efficacy , reduce their symptom load and engage in more self-help activities to deal with their everyday lives .


After successfully evaluating this psychosocial intervention , a new health care model for the management of symptoms of anxiety , depression and somatoform disorders for ambulatory patients could emerge , supplementing the work of the GP .


To compare the safety and efficacy of dexmedetomidine/propofol ( DP ) - total i.v. anaesthesia ( TIVA ) vs remifentanil/propofol ( RP ) - TIVA , both with spontaneous breathing , during airway foreign body ( FB ) removal in children .


Seventy-seven children undergoing rigid bronchoscopy for FB removal were randomly allocated to receive either RP-TIVA and spontaneous ventilation ( Group RP , n = @ ) or DP-TIVA and spontaneous ventilation ( Group DP , n = @ ) .


Heart rate , arterial pressure , pulse oxygen saturation ( Sp ( O@ ) ) , respiratory rate , end-tidal CO@ ( E ' ( CO@ ) ) , and induction time were recorded .


Adverse events , the intervention for these events , and postoperative care duration were also assessed .


The mean induction times were comparable between the two groups ( Group RP @ min vs Group DP @ min , P > @ ) .


At the end of the procedure , the mean ( E ' ( CO@ ) ) was higher in Group RP ( Group RP @ kPa vs Group DP @ kPa , P < @ ) , and respiratory rate was lower in Group RP ( Group RP @ vs Group DP @ , P < @ ) .


Additionally , the perioperative haemodynamic profile was more stable in Group DP than that in Group RP .


The incidence rate of breath-holding and intervention were comparable between the two groups .


In the post-anaesthesia care unit ( PACU ) , no hypoxaemia was observed , and emergence time increased in Group DP ( Group DP @ min vs Group RP @ min , P < @ ) .


The incidence of cough in PACU was higher in Group RP ( Group RP @ % vs Group DP @ % , P < @ ) .


Compared with RP-TIVA , DP-TIVA provided more stable respiratory and haemodynamic profiles , but required a longer recovery time .


Clinical trial registration China Clinical Research Information Service , ChiCTR-TRC-@ .


PPARGC@A and PPARGCB encode transcriptional coactivators that regulate numerous metabolic processes .


We tested associations and treatment ( i.e. metformin or lifestyle modification ) interactions with metabolic traits in the Diabetes Prevention Program , a randomised controlled trial in persons at high risk of type @ diabetes .


We used Tagger software to select @ PPARGCA@ and @ PPARGC@B tag single-nucleotide polymorphisms ( SNPs ) for analysis .


These SNPs were tested for associations with relevant cardiometabolic quantitative traits using generalised linear models .


Aggregate genetic effects were tested using the sequence kernel association test .


In aggregate , PPARGC@A variation was strongly associated with baseline triacylglycerol concentrations ( p = @ ( -@ ) ) , BMI ( p = @ ( -@ ) ) and visceral adiposity ( p = @ ( -@ ) ) , as well as with changes in triacylglycerol concentrations ( p = @ ( -@ ) ) and BMI ( p = @ ( -@ ) ) from baseline to @ year .


PPARGC@B variation was only associated with baseline subcutaneous adiposity ( p = @ ) .


In individual SNP analyses , Gly@Ser ( rs@ , PPARGC@A ) was associated with accumulation of subcutaneous adiposity and worsening insulin resistance at @ year ( both p < @ ) , while rs@ ( PPARGC@A ) modified the effects of metformin on triacylglycerol levels ( p ( interaction ) = @ ) .


These findings provide several novel and other confirmatory insights into the role of PPARGC@A variation with respect to diabetes-related metabolic traits .


The possible relationship between the circulating concentrations of T@ and GH sensitivity has not been elucidated .


The aim of this study is to evaluate the effect of levothyroxine supplementation on GH sensitivity in prepubertal boys with idiopathic short stature ( ISS ) .


We selected @ prepubertal boys with ISS ( mean age @ years ) and free T@ ( Ft@ ) concentrations between the @rd and the @th percentiles ( Ft@ : @-@ @ ng/dl ) .


They were randomly divided into two groups : Group A received thyroid supplementation ( @-@g / kg/day ) for @days , and Group B received placebo for the same period .


To evaluate GH sensitivity , an IGF-I generation test ( GH : @g/kg/day sc for @days ) was performed in both groups : under basal conditions , and after @days of levothyroxine supplementation ( or placebo ) .


After thyroid supplementation , Group A had higher Ft@ concentrations compared with Group B ( @ vs @ ng/dl , p = @ ) , their growth velocity was significantly higher ( @ vs @ cm/@months ) , and they exhibited a greater increase in IGF-I after GH administration ( Group A : @ % vs Group B @ % ) .


Supplementation with levothyroxine for @days promotes an increase in growth velocity , and a greater IGF-I response to short-term GH administration in prepubertal boys with ISS and low-normal thyroid hormone concentrations .


Although conventional laparoscopic colectomy is a validated technique , laparoscopic natural-orifice specimen extraction ( NOSE ) colectomy might improve outcome .


This randomized clinical trial compared analgesia requirements , postoperative pain , anorectal function , inflammatory response and cosmesis in laparoscopic NOSE colectomy and conventional laparoscopic colectomy .


Patients were randomly assigned to undergo laparoscopic NOSE colectomy or conventional laparoscopic colectomy for left-sided colonic disease .


The primary endpoint was analgesia requirement .


Secondary endpoints were operative outcome , inflammatory response , anorectal function and cosmesis .


Forty patients were enrolled in the study , @ in each group ( @ with diverticulitis and @ with colorectal cancer in each group ) .


A significant difference was observed in morphine analogue requirements ( @ of @ patients in the NOSE group versus @ of @ in the conventional group ; P = @ ) .


Patient-controlled epidural analgesia was lower in the NOSE group ( mean @ml versus @ml in the conventional group ; P < @ ) , as was paracetamol use ( mean @ versus @g respectively ; P < @ ) .


Postoperative pain scores were lower in the NOSE group : mean maximum visual analogue score of @ versus @ ( P < @ ) .


One week after hospital discharge , pain scores remained higher in the conventional group : @ of @ patients in the conventional group reported pain , compared with one of @ in the NOSE group ( P < @ ) .


Inflammatory responses were greater in patients undergoing NOSE colectomy : higher peak C-reactive protein and interleukin @ levels were observed on postoperative day @ ( P < @ ) and day @ ( P = @ ) respectively .


Postoperative anorectal function , complications and hospital stay were similar in the two groups .


Laparoscopic NOSE colectomy was associated with less pain and lower analgesia requirements than the conventional laparoscopic extraction .


This study was designed to evaluate the dose-effect relationship of statins in patients with ischemic congestive heart failure ( CHF ) , since the role of statins in CHF remains unclear .


The South koreAn Pitavastatin Heart FaIluRE ( SAPHIRE ) study was designed to randomize patients with ischemic CHF into daily treatments of @ mg pravastatin or @ mg pitavastatin .


The low density lipoprotein cholesterol level decreased by @ % in the pitavastatin group compared with @ % in the pravastatin ( p < @ ) group .


Left ventricular systolic dimensions decreased significantly by @ % in the pitavastatin group and by @ % in the pravastatin group .


Left ventricular ejection fraction ( EF ) improved significantly from @ % to @ % in the pitavastatin group and from @ % to @ % in the pravastatin group .


Although the extent of the EF change was greater in the pitavastatin group ( @ % vs. @ % ) than that in the pravastatin group , no significant difference was observed between the groups ( p = @ ) .


Exercise capacity , evaluated by the @-min walking test , improved significantly in the pravastatin group ( p < @ ) , but no change was observed in the pitavastatin group ( p = @ ) .


Very low dose/low potency pravastatin and high dose/high potency pitavastatin had a beneficial effect on cardiac reverse remodeling and improved systolic function in patients with ischemic CHF .


However , only pravastatin significantly improved exercise capacity .


These findings suggest that lowering cholesterol too much may not be beneficial for patients with CHF .


Impetigo affects more than @ million children worldwide at any one time .


The major burden of disease is in developing and tropical settings where topical antibiotics are impractical and lead to rapid emergence of antimicrobial resistance .


Few trials of systemic antibiotics are available to guide management of extensive impetigo .


As such , we aimed to compare short-course oral co-trimoxazole with standard treatment with intramuscular benzathine benzylpenicillin in children with impetigo in a highly endemic setting .


In this randomised , controlled , non-inferiority trial , Indigenous Australian children aged @ months to @ years with purulent or crusted non-bullous impetigo were randomly assigned ( @:@:@ ) to receive benzathine benzylpenicillin ( weight-banded injection ) , twice-daily co-trimoxazole for @ days ( @ mg/kg plus @ mg/kg per dose ) , or once-daily co-trimoxazole for @ days ( @ mg/kg plus @ mg/kg per dose ) .


At every visit , participants were randomised in blocks of six and @ , stratified by disease severity .


Randomisation was done by research nurses and codes were in sealed , sequentially numbered , opaque envelopes .


Independent reviewers masked to treatment allocation compared digital images of sores from days @ and @ .


The primary outcome was treatment success at day @ in a modified intention-to-treat analysis .


This trial is registered with the Australian New Zealand Clinical Trials Registry , number ACTRN@ .


Between Nov @ , @ , and Nov @ , @ , @ patients were randomly assigned to receive benzathine benzylpenicillin ( n = @ -LSB- @ analysed -RSB- ) , twice-daily co-trimoxazole for @ days ( n = @ -LSB- @ analysed -RSB- ) , or once-daily co-trimoxazole for @ days ( n = @ -LSB- @ analysed -RSB- ) .


Treatment was successful in @ ( @ % ) children who received benzathine benzylpenicillin and @ ( @ % ) who received pooled co-trimoxazole ( absolute difference @ % ; @ % CI -@ to @ ) , showing non-inferiority of co-trimoxazole ( @ % margin ) .


Results for twice-daily co-trimoxazole for @ days and once-daily co-trimoxazole for @ days were similar .


Adverse events occurred in @ participants , @ ( @ % ) of whom received benzathine benzylpenicillin .


Short-course co-trimoxazole is a non-inferior , alternative treatment to benzathine benzylpenicillin for impetigo ; it is palatable , pain-free , practical , and easily administered .


An unmet need exists for interferon-free and ribavirin-free treatments for chronic hepatitis C virus ( HCV ) infection .


In this study , we assessed all-oral therapy with daclatasvir ( NS@A replication complex inhibitor ) plus asunaprevir ( NS@ protease inhibitor ) in patients with genotype @b infection , including those with high unmet needs or cirrhosis , or both .


We did this phase @ , multicohort study ( HALLMARK-DUAL ) at @ sites in @ countries between May @ , @ , and Oct @ , @ .


Patients were adults with chronic HCV genotype @b infection who were treatment-naive ; previous non-responders to peginterferon alfa plus ribavirin ; or medically ineligible for , previously intolerant of , or ineligible for and intolerant of peginterferon alfa plus ribavirin .


Treatment-naive patients were randomly assigned ( @:@ ratio ) by an interactive voice-response system with a computer-generated random allocation sequence ( stratified by cirrhosis status ) to receive daclatasvir @ mg once daily plus asunaprevir @ mg twice daily or placebo for @ weeks .


Patients and investigator sites were masked to treatment assignment and HCV RNA results to the end of week @ .


The treatment-naive group assigned to daclatasvir plus asunaprevir continued open-label treatment to the end of week @ ; participants assigned to placebo entered another daclatasvir plus asunaprevir study .


Non-responders and ineligible , intolerant , or ineligible and intolerant patients received open-label daclatasvir plus asunaprevir for @ weeks .


The primary endpoint was sustained virological response at post-treatment week @ .


Efficacy analyses were restricted to patients given daclatasvir plus asunaprevir .


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


This study included @ treatment-naive patients ( @ received daclatasvir plus asunaprevir and @ received placebo ; all randomly assigned patients received the intended treatment ) , @ non-responders , and @ ineligible , intolerant , or ineligible and intolerant patients .


Daclatasvir plus asunaprevir provided sustained virological response in @ ( @ % , @ % CI @-@ ) patients in the treatment-naive cohort , @ ( @ % , @-@ ) in the non-responder cohort , and @ ( @ % , @-@ ) in the ineligible , intolerant , or ineligible and intolerant cohort .


Serious adverse events occurred in @ ( @ % ) patients in the treatment-naive group ; @ ( @ % ) non-responders , and @ ( @ % ) ineligible , intolerant , or ineligible and intolerant patients ; adverse events leading to discontinuation ( most commonly reversible increases in alanine or aspartate aminotransferase ) occurred in six ( @ % ) , two ( @ % ) , and two ( @ % ) patients , respectively , with no deaths recorded .


Grade @ or @ laboratory abnormalities were uncommon , with low incidences of aminotransferase increases during the first @ weeks with daclatasvir plus asunaprevir and placebo in treatment-naive patients ( @ % each ) .


Daclatasvir plus asunaprevir provided high sustained virological response rates in treatment-naive , non-responder , and ineligible , intolerant , or ineligible and intolerant patients , and was well tolerated in patients with HCV genotype @b infection .


These results support the use of daclatasvir plus asunaprevir as an all-oral , interferon-free and ribavirin-free treatment option for patients with HCV genotype @b infection , including those with cirrhosis .


To determine the normal variation in central retinal thickness asymmetry in healthy Caucasian adults using the posterior pole asymmetry analysis ( PPAA ) of a SPECTRALIS spectral-domain optical coherence tomography ( SD-OCT ) device .


Healthy Caucasian individuals aged between @ and @ years with a visual acuity of minimum @/@ and a spherical equivalent between -@ and +@ diopters were recruited .


Retinal thickness and retinal nerve fiber layer thickness ( RNFL ) were using measured SPECTRALIS SD-OCT .


Inter - and intraocular differences in central retinal thickness were calculated using the PPAA .


The association between age , sex , and interocular asymmetry was evaluated by a linear model with Gaussian correlation structure .


A total of @ individuals , @ men and @ women , were studied .


The mean age SD was @ @ years .


The grand mean interocular retinal thickness asymmetry was @ m ( @ % confidence interval -LSB- CI -RSB- : @-@ @ ) and the grand mean intraocular retinal thickness asymmetry was @ m ( @ % CI : @-@ @ ) in the right eye and @ m ( @ % CI : @-@ @ ) in the left eye .


The highest local asymmetries were found in the nasal corners of macula were the posterior pole thickness map overlaps the temporal vascular arches .


A slight general age and sex effect on the mean interocular retinal thickness asymmetry was found to be respectively @ m/year ( @ % CI : @-@ @ m ) and @ m ( @ % CI : @-@ @ m ) for men compared with women .


Statistically significant physiological asymmetries in inter - and intraocular central retinal thickness exist .


This must be considered when early signs of glaucoma or other pathologies are evaluated based on the retinal thickness asymmetry .


( http://www.controlled-trials.com/isrctn/ number , ISRCTN@ . )


We seek to test the efficacy of noninvasive sphenopalatine ganglion block for the treatment of acute anterior headache in the emergency department ( ED ) using a novel noninvasive delivery device .


We conducted a randomized , double-blind , placebo-controlled trial evaluating bupivacaine anesthesia of the sphenopalatine ganglion for acute anterior or global-based headache .


This study was completed in @ large academic EDs .


Bupivacaine or normal saline solution was delivered intranasally ( @ mL per side ) with the Tx@ device .


Pain and nausea were measured at @ , @ , and @ minutes by a @-mm visual analog scale .


The primary endpoint was a @ % reduction in pain at @ minutes .


Telephone follow-up assessed @-hour pain and nausea through a @ - to @-point verbal scale and adverse effects .


The median reported baseline pain in the bupivacaine group was @ mm ( IQR @ mm - @ mm ) and @ mm ( IQR @ mm to @ mm ) in the normal saline solution group .


A @ % reduction in pain was achieved in @ % of the bupivacaine group ( @/@ patients ) versus @ % in the normal saline solution group ( @/@ patients ) , for an absolute risk difference of @ % ( @ % confidence interval -LSB- CI -RSB- -@ % to @ % ) .


As a secondary outcome , at @ hours , more patients in the bupivacaine group were headache free ( @ % difference ; @ % CI @ % to @ % ) and more were nausea free ( @ % difference ; @ % CI @ % to @ % ) .


For patients with acute anterior headache , sphenopalatine ganglion block with the Tx@ device with bupivacaine did not result in a significant increase in the proportion of patients achieving a greater than or equal to @ % reduction in headache severity at @ minutes compared with saline solution applied in the same manner .


Vibration anesthesia is an effective pain-reduction technique for facial cosmetic injections .


The analgesic effect of this method was tested in this study during facial dermal filler injections .


The study aimed to evaluate the safety and efficacy of vibration anesthesia for these facial injections .


This prospective study analyzed @ patients who received dermal filler injections to the nasolabial folds , tear troughs , cheeks , and other facial sites .


The injections were administered in a randomly assigned split-face design .


One side of the patient 's face received vibration together with dermal filler injections , whereas the other side received dermal filler injections alone .


The patients completed a posttreatment questionnaire pertaining to injection pain , adverse effects , and preference for vibration with future dermal filler injections .


The patients experienced both clinically and statistically significant pain reduction when a vibration stimulus was co-administered with the dermal filler injections .


No adverse events were reported .


The majority of the patients ( @ % ) reported a preference for vibration anesthesia with subsequent dermal filler injections .


Vibration is a safe and effective method of achieving anesthesia during facial dermal filler injections .


This journal requires that authors assign a level of evidence to each article .


For a full description of these Evidence-Based Medicine ratings , please refer to the Table of Contents or the online Instructions to Authors www.springer.com/@ .


The Institute of Medicine recommends developing a broader workforce of mental health providers , including nontraditional providers , to expand services for older adults .


Cognitive behavior therapy ( CBT ) is effective for late-life generalized anxiety disorder ( GAD ) , but no study has examined outcomes with delivery by lay providers working under the supervision of licensed providers .


The current study examined the effects of CBT delivered by lay , bachelor-level providers ( BLP ) relative to Ph.D.-level expert providers ( PLP ) , and usual care ( UC ) in older adults with GAD .


Participants were @ older adults ( mean age , @ years ) with GAD recruited from primary care clinics at two sites and assigned randomly to BLP ( n = @ ) , PLP ( n = @ ) , or UC ( n = @ ) .


Assessments occurred at baseline and @ months .


CBT in BLP and PLP included core and elective modules ( @ months : skills training ; @ months : skills review ) delivered in person and by telephone , according to patient choice .


CBT in both BLP and PLP groups significantly improved GAD severity ( GAD Severity Scale ) , anxiety ( Spielberger State-Trait Anxiety Inventory ; Structured Interview Guide for the Hamilton Anxiety Scale ) , depression ( Patient Health Questionnaire ) , insomnia ( Insomnia Severity Index ) , and mental health quality of life ( Short-Form-@ ) , relative to UC .


Response rates defined by @ % reduction from pre - to posttreatment in at least three of four primary outcomes were higher for study completers in BLP and PLP relative to UC ( BLP : @ % ; PLP : @ % ; UC : @ % ) .