Enthusiasm for simulation early in cardiothoracic surgery training is growing , yet evidence demonstrating its utility is limited .


We examined the effect of supervised and unsupervised training on coronary anastomosis performance in a randomized trial among medical students .


Forty-five medical students were recruited for this single-blinded , randomized controlled trial using a low-fidelity simulator .


After viewing an instructional video , all participants attempted an anastomosis .


Subsequently , the participants were randomized to @ of @ groups : control ( n = @ ) , unsupervised training ( n = @ ) , or supervised training with a cardiothoracic surgeon or fellow ( n = @ ) .


Both the supervised and unsupervised groups practiced for @ hour per week .


After @ weeks , the participants repeated the anastomosis .


All pre - and posttraining performances were videotaped and rated independently by @ cardiothoracic surgeons blinded to the randomization .


All raters scored @ assessment items on a @ to @ ( low-high ) scale along with an overall pass/fail rating .


After the training period , all @ groups showed significant improvements in composite scores ( control : +@ @ -LSB- P = @ -RSB- , unsupervised : +@ @ -LSB- P < @ -RSB- , and supervised : +@ @ -LSB- P < @ -RSB- ) .


Compared with control group , both supervised ( P = @ ) and unsupervised trainees ( P = @ ) demonstrated a significant improvement .


Between the supervised and unsupervised groups there were no statistically significant differences in composite scores .


Practice on low-fidelity simulators enabled trainees to improve on a broad range of skills ; however , the additional effect of attending-level supervision is limited .


In an era of increasing staff surgeon responsibilities , unsupervised practice may be sufficient for inexperienced trainees .


Cerebral vasospasm following subarachnoid hemorrhage ( SAH ) causes significant morbidity in a delayed fashion .


The authors recently published a new scale that grades the maximum thickness of SAH on axial CT and is predictive of vasospasm incidence .


In this study , the authors further investigate whether different aneurysm locations result in different SAH clot burdens and whether any concurrent differences in ruptured aneurysm location and maximum SAH clot burden affect vasospasm incidence .


Two hundred fifty patients who were part of a prospective randomized controlled trial were reviewed .


Most outcome and demographic variables were included as part of the prospective randomized controlled trial .


Additional variables were also collected at a later time , including vasospasm data and maximum clot thickness .


Aneurysms were categorized into @ of @ groups : intradural internal carotid artery aneurysms , vertebral artery ( VA ) aneurysms ( including the posterior inferior cerebellar artery ) , basilar trunk or basilar apex aneurysms , middle cerebral artery aneurysms , pericallosal aneurysms , and anterior communicating artery aneurysms .


Twenty-nine patients with nonaneurysmal SAH were excluded .


Patients with pericallosal aneurysms had the least average maximum clot burden ( @ mm ) , compared with @ mm for the group overall , but had the highest rate of symptomatic vasospasm ( @ % vs @ % overall , OR @ , RR @ , p = @ ) .


Symptomatic vasospasm occurrence was tallied in patients with clinical deterioration attributable to delayed cerebral ischemia .


There were no significant differences in maximum clot thickness between aneurysm sites .


Middle cerebral artery aneurysms resulted in the thickest mean maximum clot ( @ mm ) but rates of symptomatic and radiographic vasospasm in this group were statistically no different compared with the overall group .


Vertebral artery aneurysms had the worst @-year modified Rankin scale ( mRS ) scores ( @ vs @ overall , respectively ; p = @ ) .


A @-year mRS score of @-@ ( good outcome ) was found in @ % of patients overall , but in only @ % of those with pericallosal and VA aneurysms , and in @ % of those with basilar artery aneurysms ( p = @ ) .


Patients with stroke from vasospasm had higher mean clot thickness ( @ vs @ mm , p = @ ) .


The location of a ruptured aneurysm minimally affects the maximum thickness of the SAH clot but is predictive of symptomatic vasospasm or clinical deterioration from delayed cerebral ischemia in pericallosal aneurysms .


The worst @-year mRS outcomes in this cohort of patients were noted in those with posterior circulation aneurysms or pericallosal artery aneurysms .


Patients experiencing stroke had higher mean clot burden .


To evaluate the short-term benefits of simple relaxation techniques in white-collar employees .


The study was a two-arm parallel group randomized controlled trial .


@ employees were randomly assigned to receive the @-week programme ( N = @ ) ( relaxation breathing and progressive muscle relaxation , twice a day ) or not ( wait-list group N = @ ) .


Self-reported validated measures were used to evaluate perceived stress , health locus of control , job and lifestyle related variables .


Saliva cortisol were also sampled and measured .


Adjusted mean changes on outcomes were estimated by linear mixed model analysis .


@ employees were finally analyzed ( @ in the intervention and @ in the control group ) .


Specific stress-related symptoms , psychological job demands and cortisol levels were found to be significantly decreased after @-weeks in the intervention group .


The result was probably affected by the general socio-economic condition during the study period .


Cortisol levels were also significantly related with age , family situation , gender and sampling time .


Simple relaxation training ( diaphragmatic breathing and progressive muscle relaxation ) could benefit employees and it is strongly proposed that these and other similar techniques should be tested in various labour settings .


Faecal short chain fatty acids ( SCFAs ) are produced by the gut microflora .


We have previously reported high faecal SCFA levels in children with coeliac disease ( CD ) , indicating alteration in gut microfloral metabolism .


Data accumulated over recent decades by us and others suggest that wheat-free oats can safely be included in a gluten-free diet ( GFD ) .


However , concerns have been raised with respect to the safety of oats in a subset of coeliacs .


To describe faecal SCFA patterns in children with newly diagnosed CD treated for @ year with a GFD with or without oats .


This report is part of a randomised , double-blind study on the effect of a GFD containing oats ( GFD-oats ) vs. a standard GFD ( GFD-std ) .


Faecal samples were received from @ children in the GFD-oats group and @ in the GFD-std group at initial diagnosis and/or after @ year on a GFD .


Faecal SCFAs were analysed .


The GFD-std group had a significantly lower total faecal SCFA concentration at @ months compared with @ months ( P < @ ) .


In contrast , total SCFA in the GFD-oats group remained high after @ year on the GFD .


The children in the GFD-oats group had significantly higher acetic acid ( P < @ ) , n-butyric acid ( P < @ ) and total SCFA concentration ( P < @ ) after @-year diet treatment compared to the GFD-std group .


Our results indicate that oats do affect the gut microflora function , and that some coeliac children receiving oats may develop gut mucosal inflammation , that may present a risk for future complications .


Prucalopride is a selective , high-affinity agonist of the @-hydroxytryptamine ( serotonin ) receptor @ that enhances motility in the gastrointestinal tract .


We performed a multicenter , randomized , placebo-controlled , double-blind , phase @ trial to evaluate the efficacy and safety of prucalopride in children ( @ months to @ years old ) with functional constipation .


Children with functional constipation , based on the Rome III criteria , were given prucalopride ( children @ kg were given a @ mg/kg oral solution ; children > @ kg were given a @-mg tablet ) or placebo once daily for @ weeks .


The primary efficacy end point was the proportion of children with toileting skills who had a mean of @ spontaneous bowel movements/week and @ episode of fecal incontinence/@ weeks , from study weeks @-@ ( responders ) .


Adverse events , clinical laboratory values , and electrocardiograms were monitored .


Efficacy and safety were assessed in @ children ( @ prucalopride , @ placebo ) .


Twenty-five percent were younger than @ years old , @ % were @-@ years old , and @ % were @-@ years old ; @ % were girls .


At screening , @ % of patients in the prucalopride group and @ % in the placebo group had a history of fecal incontinence ; @ % and @ % in the prucalopride and placebo groups , respectively , had a mean of @ spontaneous bowel movements/week .


The proportion of responders was similar between groups ( prucalopride , @ % and placebo , @ % ) .


There were no statistically significant differences in the primary efficacy end point when patients were stratified by sex , age group , or country .


The incidence of treatment-emergent adverse events was similar in the prucalopride ( @ % ) and placebo ( @ % ) groups .


Prucalopride , although generally well tolerated , was not more effective than placebo in children with functional constipation .


ClinicalTrials.gov Number : NCT@ .


Epidemiologic studies have reported inconsistent associations of vitamin D and prostate cancer risk ; however , few have adequately controlled for detection bias related to prostate-specific antigen ( PSA ) screening , and the results of many studies may be affected by occult prostate cancers among controls .


Data for this nested case-control analysis ( n = @,@ cases/@ ,@ controls ) are from the Prostate Cancer Prevention Trial .


Baseline serum was analyzed for @-hydroxyvitamin D -LSB- @ ( OH ) D -RSB- .


The presence or absence of cancer was subsequently determined by prostate biopsy .


Polytomous logistic regression models were used to estimate associations of @ ( OH ) D with risk of total , Gleason @-@ , Gleason @ , and Gleason @-@ prostate cancer .


Results are presented for placebo and finasteride arms separately and combined .


There were no associations of serum @ ( OH ) D with total prostate cancer risk .


For Gleason @-@ cancers , results were inconsistent across treatment arms with a suggestion of increased risk in the placebo arm only ; however , there was no dose-response relationship .


For Gleason @-@ prostate cancers , @ ( OH ) D concentrations were associated with a linear decrease in risk among combined treatment arms -LSB- quartile @ vs. @ : OR , @ ; @ % confidence interval ( CI ) , @-@ @ ; P ( trend ) = @ -RSB- .


These findings were somewhat stronger among men @ versus @-@ years at baseline ( quartile @ vs. @ : OR , @ ; @ % CI , @-@ @ vs. OR , @ ; @ % CI , @-@ @ , respectively ; P ( interaction ) = @ ) .


Higher serum @ ( OH ) D may modestly increase risk of Gleason @-@ disease and more substantially reduce risk of Gleason @-@ prostate cancer .


Vitamin D may have different effects for different stages of prostate cancers .


Antidepressant response varies between patients , possibly due to differences in the rate cytochrome P@ enzymes metabolise antidepressants into inactive compounds .


Drug metabolism rates are influenced by common variants in the genes encoding these enzymes .


However , it remains unclear whether treatment outcomes can be predicted by either CYP@ genotype or antidepressant serum concentration .


In GENDEP ( a pharmacogenetic study of depressed individuals treated with either escitalopram or nortriptyline ) , serum concentrations of antidepressants and their primary metabolite were measured after eight weeks treatment and variants in CYP@D@ and CYP@C@ were genotyped .


Amongst patients taking escitalopram ( n = @ ) , the genotype CYP@C@ was significantly associated with escitalopram serum concentrations and desmethylescitalopram : escitalopram ratio .


For those taking nortriptyline ( n = @ ) , the CYP@D@ genotype was significantly associated with nortriptyline and @-hydroxynortriptyline serum concentrations and @-hydroxynortriptyline : nortrip-tyline ratio .


CYP@ genotypes conferring greater enzyme activity were linked to lower drug serum concentrations and higher metabolite : drug ratios .


Nonetheless , no significant association was found between either CYP@ genotype or antidepressant serum concentration and treatment response .


While there is a significant relationship between the CYP@ genotype and serum concentrations of escitalopram and nortriptyline , the genotypes are not predictive of differences in treatment response for either drug .


Furthermore , differences in antidepressant serum concentrations are not associated with variability in treatment response .


Atrial fibrillation is a leading preventable cause of recurrent stroke for which early detection and treatment are critical .


However , paroxysmal atrial fibrillation is often asymptomatic and likely to go undetected and untreated in the routine care of patients with ischemic stroke or transient ischemic attack ( TIA ) .


We randomly assigned @ patients @ years of age or older , without known atrial fibrillation , who had had a cryptogenic ischemic stroke or TIA within the previous @ months ( cause undetermined after standard tests , including @-hour electrocardiography -LSB- ECG -RSB- ) , to undergo additional noninvasive ambulatory ECG monitoring with either a @-day event-triggered recorder ( intervention group ) or a conventional @-hour monitor ( control group ) .


The primary outcome was newly detected atrial fibrillation lasting @ seconds or longer within @ days after randomization .


Secondary outcomes included episodes of atrial fibrillation lasting @ minutes or longer and anticoagulation status at @ days .


Atrial fibrillation lasting @ seconds or longer was detected in @ of @ patients ( @ % ) in the intervention group , as compared with @ of @ ( @ % ) in the control group ( absolute difference , @ percentage points ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ ; number needed to screen , @ ) .


Atrial fibrillation lasting @ minutes or longer was present in @ of @ patients ( @ % ) in the intervention group , as compared with @ of @ ( @ % ) in the control group ( absolute difference , @ percentage points ; @ % CI , @ to @ ; P < @ ) .


By @ days , oral anticoagulant therapy had been prescribed for more patients in the intervention group than in the control group ( @ of @ patients -LSB- @ % -RSB- vs. @ of @ -LSB- @ % -RSB- ; absolute difference , @ percentage points ; @ % CI , @ to @ ; P = @ ) .


Among patients with a recent cryptogenic stroke or TIA who were @ years of age or older , paroxysmal atrial fibrillation was common .


Noninvasive ambulatory ECG monitoring for a target of @ days significantly improved the detection of atrial fibrillation by a factor of more than five and nearly doubled the rate of anticoagulant treatment , as compared with the standard practice of short-duration ECG monitoring .


( Funded by the Canadian Stroke Network and others ; EMBRACE ClinicalTrials.gov number , NCT@ . )


Acute lymphoblastic leukemia ( ALL ) is the most common pediatric cancer .


Monitoring minimal residual disease ( MRD ) by using real-time quantitative polymerase chain reaction ( RQ-PCR ) provides information for patient stratification and individual risk-directed treatment .


Cooperative studies have documented that measurement of blast clearance from the bone marrow during and after induction therapy identifies patient populations with different risk of relapse .


We explored the possible contribution of measurements of MRD during the course of treatment .


We used RQ-PCR to detect MRD in @ unselected patients treated in Italy in the International Collaborative Treatment Protocol for Children and Adolescents With Acute Lymphoblastic Leukemia ( AIEOP-BFM ALL @ ) .


The trial took place in AIEOP centers during postinduction chemotherapy .


Results were categorized as negative , low positive ( below the quantitative range -LSB- < @ @ ( -@ ) -RSB- ) , or high positive ( @ @ ( -@ ) ) .


Patients with at least one low-positive or high-positive result were assigned to the corresponding subgroup .


Patients who tested high positive , low positive , or negative had significantly different cumulative incidences of leukemia relapse : @ % , @ % , and @ % , respectively ( P < @ ) .


Two thirds of positive cases were identified within @ months after induction-consolidation therapy , suggesting that this time frame may be most suitable for cost-effective MRD monitoring , particularly in patients who did not clear their disease at the end of consolidation .


These findings provide further insights into the dynamic of MRD and the ongoing effort to define molecular relapse in childhood ALL .


Our objective was to assess therapeutic non-inferiority of dual treatment with lopinavir-ritonavir and lamivudine to triple treatment with lopinavir-ritonavir plus two nucleos ( t ) ides for maintenance of HIV-@ viral suppression .


In this randomised , open-label , non-inferiority trial , we recruited patients from @ HIV units in hospitals in Spain and France .


Eligible patients were HIV-infected adults ( aged @ years ) with HIV-@ RNA of less than @ copies per mL , for at least @ months on triple treatment with lopinavir-ritonavir ( twice daily ) plus lamivudine or emtricitabine and a second nucleos ( t ) ide , with no resistance or virological failure to these drugs , and no positive hepatitis B serum surface antigen .


Investigators at each centre randomly assigned patients ( @:@ ; block size of four ; stratified by time to suppression -LSB- < @ year or > @ year -RSB- and nadir CD@ cell count -LSB- < @ cells per L or > @ cells per L -RSB- ; computer-generated random sequence ) to continue triple treatment or switch to dual treatment ( oral lopinavir @ mg and oral ritonavir @ mg twice daily plus oral lamivudine @ mg once daily ) .


The primary endpoint was response to treatment in the intention-to-treat population ( all randomised patients ) at @ weeks .


The non-inferiority margin was @ % .


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


Between Oct @ , @ , and April @ , @ , we randomly assigned @ participants to continue triple treatment ( @ -LSB- @ % -RSB- patients ) or switch to dual treatment ( @ -LSB- @ % -RSB- patients ) .


In the intention-to-treat population , @ ( @ % ) of @ patients in the triple-treatment group responded to treatment versus @ ( @ % ) of @ in the dual-treatment group ( difference -@ % -LSB- @ % CI -@ to @ -RSB- ; p = @ ) , meeting the criteria for non-inferiority .


Serious adverse events occurred in eight ( @ % ) patients in the triple-treatment group and five ( @ % ) in the dual-treatment group ( p = @ ) , and study drug discontinuations due to adverse events occurred in four ( @ % ) in the triple-treatment group and one ( @ % ) in the dual-treatment group ( p = @ ) .


Dual treatment with lopinavir-ritonavir plus lamivudine has non-inferior therapeutic efficacy and is similarly tolerated to triple treatment .


Factors and outcomes associated with end-of-life decision-making among patients during clinical trials in the intensive care unit are unclear .


We sought to determine patterns and outcomes of Do Not Resuscitate ( DNR ) decisions among critically ill patients with acute respiratory distress syndrome ( ARDS ) enrolled in a clinical trial .


We performed a secondary analysis of data from the ARDS Network Fluid and Catheter Treatment Trial ( FACTT ) , collected between @ and @ .


We calculated mortality outcomes stratified by code status , and compared baseline characteristics of patients who became DNR during the trial with participants who remained full code .


Among @ FACTT participants with a code status recorded , @ ( @ % ) elected DNR status .


Specifically , @ ( @ % ) chose to withhold cardiopulmonary resuscitation alone , @ ( @ % ) elected to withhold some life support measures in addition to cardiopulmonary resuscitation , and @ ( @ % ) had life support withdrawn .


Admission severity of illness as measured by APACHE III score was strongly associated with election of DNR status ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


Almost all ( @ % ; @ of @ ) patients who selected DNR status died , and @ % ( @ of @ ) of patients who died during the trial were DNR .


Among patients who chose DNR status but did not elect withdrawal of life support , @ % ( @ of @ ) died .


The vast majority of deaths among clinical trial patients with ARDS were preceded by a DNR order .


Unlike other studies of end-of-life decision-making in the intensive care unit , nearly all patients who became DNR died .


The impact of variation of practice in end-of-life decision-making during clinical trials warrants further study .


Etravirine ( ETR ) was approved for patients with virological failure and antiretroviral resistance mutations .


It has also shown antiviral efficacy in antiretroviral-nave patients .


However , data on the switching from protease inhibitors ( PI ) to ETR are lacking .


HIV-@-infected patients with suppressed viral load ( VL ) during a PI-containing regimen ( > @ months ) and no previous virological failure were randomized to switch from the PI to ETR ( @ mg/day , dissolved in water ) ( ETR group , n = @ ) or to continue with the same regimen ( control group , n = @ ) .


Percentage of patients with VL @ copies/mL were assessed at week @ , as well as changes in CD@ T-cell counts and metabolic profile .


We included @ patients -LSB- @ % male , @ ( @ ; @ ) years -RSB- .


Two patients receiving ETR ( grade-@ diarrhea and voluntary discontinuation ) and another in the control group ( simplification ) discontinued therapy early .


No patients presented virological failure ( two consecutive VL > @ copies/mL ) ; treatment was successful in @ % of the control group and @ % of the ETR group ( intention-to-treat analysis , missing = failure ) ( p = @ ) .


CD@ + T-cell counts did not significantly vary -LSB- +@ cells/L in the ETR group ( p = @ ) and -@ cells/L in the control group ( p = @ ) -RSB- .


The ETR group showed significant reductions in cholesterol ( p < @ ) , triglycerides ( p = < @ ) , and glycemia ( p = @ ) and higher satisfaction ( @-@ scale ) ( p = @ ) .


Trough plasma concentrations of ETR were similar to observed in studies using ETR twice daily .


Switch from a PI-based regimen to a once-daily combination based on ETR maintained undetectable VL during @ weeks in virologically suppressed HIV-infected patients while lipid profile and patient satisfaction improved significantly .


The purpose of this study was to determine the effects of deep dry needling ( DDN ) on spasticity , pressure sensitivity , and plantar pressure in patients who have had stroke .


A randomized controlled trial was conducted .


Thirty-four patients who previously had a stroke were randomly assigned either an experimental group that received a single session of DDN over the gastrocnemius and tibialis anterior muscles on the spastic leg or a control group that received no intervention .


Spasticity ( evaluated with the Ashworth Scale ) ; pressure pain thresholds over the deltoid muscle , second metacarpal , and tibialis anterior muscle ; and plantar pressure ( baropodometry ) were collected by a blinded assessor before and @ minutes after intervention .


A greater number of individuals receiving DDN exhibited decreased spasticity after the intervention ( P < @ ) .


The analysis of covariance showed that pressure pain thresholds increased bilaterally in patients receiving DDN compared with those who did not receive the intervention ( P < @ ) .


The analysis of covariance also found that patients receiving DDN experienced bilateral increases of support surface in the forefoot , unilateral increase of the support surface in the rear foot of the treated ( affected ) side , and bilateral decreases in mean pressure ( all , P < @ ) as compared with those who did not receive DDN .


Our results suggest that a single session of DDN decreases spasticity and widespread pressure sensitivity in individuals with poststroke spasticity .


Deep dry needling also induced changes in plantar pressure by increasing the support surface and decreasing the mean pressure .


To compare patient preference for either sharp incision with scissors or blunt manual cleavage of the fascia at cesarean delivery in a randomized controlled trial in which each woman was her own control .


Women undergoing primary cesarean delivery ( n = @ ) were randomized to side distribution of sharp or blunt incision of the fascia ( sharp right and blunt left or blunt right and sharp left ) and followed three months postoperatively .


The primary outcome was patient preference for the right or left side of the scar @ months postoperatively and modeled by polytomous logistic regression .


The secondary outcome was difference in pain between the two sides measured on a @-@ @ numerical rating scale at @ , @ , and @ days and @ and @ months postoperatively .


Pain scores were analyzed with a Wilcoxon signed rank test .


@ cases were analyzed and no significant difference was found in preference after three months .


Nine women preferred the sharp ( @ % , @ % CI @-@ % ) and @ the blunt side ( @ % , @ % CI @-@ % ) ( P = @ ) .


Pain scores did not differ significantly between the two sides at any time postoperatively either at rest or during mobilization .


No significant difference was found in patient preference with regard to sharp or blunt incision of the fascia , nor was there a significant difference in postoperative pain scores .


Fear of childbirth is a common reason for seeking cesarean section .


It is important to consider outcomes and costs associated with alternative treatment and delivery mode .


We compared well-being and costs of group psychoeducation and conventional care for fear of childbirth .


Randomized controlled trial .


A total of @ nulliparous women scoring over the @th centile in the Wijma Delivery Expectancy Questionnaire ( W-DEQ ) during the first trimester .


Finland , data from obstetrical patient records and questionnaires .


Randomization to group psychoeducation with relaxation ( six sessions during pregnancy , one after childbirth , n = @ ) , or surveillance and referral on demand ( n = @ ) .


All costs in maternity care during pregnancy , delivery and postnatally according to Diagnoses Related Groups .


Life satisfaction and general well-being @ months after childbirth ( by a Satisfaction with Life Scale and Well-being Visual Analogue Scale ) .


The groups did not differ in total direct costs ( @/woman in psychoeducative group and @/woman in control group ) , nor in life satisfaction or general well-being .


Although only @ ( @ % ) of the women assigned to the surveillance were referred to special maternity care and @ ( @ % ) attended advanced prenatal classes , costs in the psychoeducation group did not exceed the costs of the controls , mostly because of the greater number of uncomplicated vaginal deliveries ( @ % vs. @ % , p = @ ) .


Through an association with safer childbirth and equal well-being after delivery , psychoeducative group treatment for nulliparous women with fear of childbirth can be a recommended choice for the same overall costs as conventional treatment .


Given the limitations in health care resources , quality-of-life measures for interventions have gained importance .


To determine whether vision-related quality-of-life outcomes were different between the natamycin and voriconazole treatment arms in the Mycotic Ulcer Treatment Trial I , as measured by an Indian Vision Function Questionnaire .


Secondary analysis ( performed October @-@ , @ ) of a double-masked , multicenter , randomized , active comparator-controlled , clinical trial at multiple locations of the Aravind Eye Care System in South India that enrolled patients with culture - or smear-positive filamentous fungal corneal ulcers who had a baseline visual acuity of @/@ to @/@ ( logMAR of @-@ @ ) .


Study participants were randomly assigned to topical voriconazole , @ % , or topical natamycin , @ % .


Subscale score on the Indian Vision Function Questionnaire from each of the @ subscales ( mobility , activity limitation , psychosocial impact , and visual function ) at @ months .


A total of @ patients were enrolled in the trial , and @ ( @ % ) completed the Indian Vision Function Questionnaire at @ months .


The majority of study participants had subscale scores consistent with excellent function .


After adjusting for baseline visual acuity and organism , we found that study participants in the natamycin-treated group scored , on average , @ points ( @ % CI , @-@ @ ) higher than study participants in the voriconazole-treated group ( P = @ ) .


In subgroup analyses looking at ulcers caused by Fusarium species and adjusting for baseline best spectacle-corrected visual acuity , the natamycin-treated group scored @ points ( @ % CI , @-@ @ ) higher than the voriconazole-treated group ( P = @ ) .


Differences in quality of life were not detected for patients with Aspergillus or other non-Fusarium species as the causative organism ( @ points -LSB- @ % CI , -@ to @ -RSB- ; P = @ ) .


We found evidence of improvement in vision-related quality of life among patients with fungal ulcers who were randomly assigned to natamycin compared with those randomly assigned to voriconazole , and especially among patients with Fusarium species as the causative organism .


Incorporation of quality-of-life measures in clinical trials is important to fully evaluate the effect of the studied interventions .


The goal of the study was to examine if intake of Lactobacillus plantarum can accelerate clearance of nontyphoid Salmonella and reduce infection-related symptoms .


Nontyphoid Salmonella is a major cause of gastroenteritis worldwide .


Few studies have explored the effect of probiotics in these infections .


Patients with Salmonella infection were randomized to daily intake of @ @ colony forming units of freeze-dried Lactobacillus plantarum @ v or placebo .


Symptoms were recorded daily .


Feces were cultured weekly .


Treatment continued until @ consecutive stool cultures negative for Salmonella had been obtained .


The treatment and placebo groups did not differ significantly with regard to time to clearance of Salmonella , or time to resolution of symptoms .


Irrespective of treatment , women tended to clear Salmonella more rapidly than men ( @ vs. @ d , P = @ ) , despite a longer diarrheal phase ( @ vs. @ days after inclusion , P = @ ) .


After Salmonella clearance ( postinfectious phase ) , women experienced loose stools , nausea , and flatulence more frequently than men .


In women , L. plantarum treatment was associated with more abdominal pain , whereas in men L. plantarum treatment reduced the prevalence of hard stools , and increased the presence of diarrheal symptoms in the postinfectious phase .


Gender , but not administration of the probiotic strain L. plantarum @ v , may influence acute symptoms during Salmonella infection and possibly clearance of Salmonella .


Symptoms in the postinfectious phase were modified by the probiotics in a gender-specific way , but our results give little support for positive effects of L. plantarum @ v treatment in nontyphoid salmonellosis .


Swallowing problems following stroke may result in increased risk of aspiration pneumonia , malnutrition , and dehydration .


Our hypothesis was that three neurostimulation techniques would produce beneficial effects on chronic dysphagia following stroke through a common brain mechanism that would predict behavioral response .


In @ dysphagic stroke patients ( mean age : @ @ years , @ female , time-post-stroke : @ @ weeks -LSB- SD -RSB- ) , pharyngeal electromyographic responses were recorded after single-pulse transcranial magnetic stimulation ( TMS ) over the pharyngeal motor cortex , to measure corticobulbar excitability before , immediately , and @ min , after real and sham applications of neurostimulation .


Patients were randomized to a single session of either : pharyngeal electrical stimulation ( PES ) , paired associative stimulation ( PAS ) or repetitive TMS ( rTMS ) .


Penetration-aspiration scores and bolus transfer timings were assessed before and after both real and sham interventions using videofluoroscopy .


Corticobulbar excitability of pharyngeal motor cortex was beneficially modulated by PES , PAS and to a lesser extent by rTMS , with functionally relevant changes in the unaffected hemisphere .


Following combining the results of real neurostimulation , an overall increase in corticobulbar excitability in the unaffected hemisphere ( P = @ , F@ ,@ = @ , ANOVA ) with an associated @ % reduction in aspiration ( P = @ , z = -@ ) was observed compared to sham .


In this mechanistic study , an increase in corticobulbar excitability the unaffected projection was correlated with the improvement in swallowing safety ( P = @ , rho = -@ ) , but modality-specific differences were observed .


Paradigms providing peripheral input favored change in neurophysiological and behavioral outcome measures in chronic dysphagia patients .


Further larger cohort studies of neurostimulation in chronic dysphagic stroke are imperative .


Active immunization , or vaccination , with tumor necrosis factor ( TNF ) - Kinoid ( TNF-K ) is a novel approach to induce polyclonal anti-TNF antibodies in immune-mediated inflammatory diseases .


This study was performed to transfer the proof of concept obtained in mice model of rheumatoid arthritis ( RA ) into human .


We designed a pilot study to demonstrate the feasibility of therapeutic vaccination in RA .


This was a phase IIa , placebo-controlled , multicenter study in adults with RA who previously experienced secondary failure of TNF antagonists .


Patients were immunized intramuscularly with @ or @ doses of placebo ( n = @ ) or @ ( n = @ ) , @ ( n = @ ) , or @ g TNF-K ( n = @ ) .


The primary objective was to identify the best dose and schedule based on anti-TNF antibody titers .


Clinical symptoms and safety were assessed during @ months and solicited reactions for @ days after each injection .


The highest anti-TNF antibody response was detected in patients immunized with @ g TNF-K and with @ injections , although this difference was not significant with all other groups .


Similar proportions of patients receiving TNF-K and placebo reported adverse events up to month @ .


Serious adverse events were reported by @ patients treated with TNF-K ( @ % ) and @ treated with placebo ( @ % ) , all unrelated to treatment .


At month @ , DAS@-CRP , tender and swollen joint counts , and HAQ scores decreased significantly more in patients who exhibited anti-TNF antibody response than in patients who did not .


TNF-K therapeutic vaccination induced dose - and schedule-dependent anti-TNF antibodies in RA patients and was well tolerated .


Patients who developed anti-TNF antibodies showed a trend toward clinical improvement .


Although the most aggressive dose and schedule , i.e. @ mg dose administered @ times , did show a strong trend of higher antibody response , further studies are warranted to examine even higher and more frequent doses in order to establish the best conditions for clinical improvement .


We evaluated the population pharmacokinetics ( PPK ) and exposure-response relationship of imatinib mesylate in Iranian patients with chronic myeloid leukemia ( CML ) .


This study was designed to assess steady state ( SS ) imatinib trough concentrations ( Cmin ) and pharmacokinetics parameters of imatinib in patients with CML in chronic phase after at least @-month treatment .


Plasma concentrations from a randomized controlled trial consist of @ patients who received oral imatinib at doses ranged between @ and @ mg in various dosing interval , which were quantified using a validated reversed-phase high-performance liquid chromatographic method with UV detection method on different occasions at SS and evaluated using PPK model .


A one-compartment model with zero-order absorption and a lag time was sufficient in describing the concentration-time profile .


Inter-individual variability ( IIV ) was modeled for all parameters .


Oral clearance ( CL/F ) and the volume of distribution ( V/F ) were estimated to @ L/h with @ % IIV and @ L with @ % IIV , respectively .


Inter-occasion variability ( IOV ) was included in CL/F ( @ % ) and V/F ( @ % ) .


The proportional residual error of the model was @ % .


Simulation analysis from individual parameters shows exposure to imatinib is highly variable among patients .


Imatinib trough plasma levels < @,@ ng/mL were associated with lower rates of major molecular response .


Because of the wide IIV compared with IOV with imatinib in our study , trough levels may play a role in investigating instances of suboptimal response .


Diabetes prevention is a public health priority that is dependent upon the reach , effectiveness , and cost of intervention strategies .


However , understanding each of these outcomes within the context of randomized controlled trials is problematic .


To describe the methods and design of a hybrid preference/randomized control trial using the RE-AIM framework .


The trial , which was developed using the RE-AIM framework , will contrast the effects of @ interventions : ( @ ) a standard care , small group , diabetes prevention education class ( SG ) , ( @ ) the small group intervention plus @ months of interactive voice response telephone follow-up ( SG-IVR ) , and ( @ ) a DVD version of the small group intervention with the same IVR follow-up ( DVD-IVR ) .


Each intervention includes personal action planning with a focus on key elements of the lifestyle intervention from the Diabetes Prevention Program ( DPP ) .


Adult patients at risk for diabetes will be randomly assigned to either choice or RCT .


Those assigned to choice ( n = @ ) will have the opportunity to choose between SG-IVR and DVD-IVR .


Those assigned to RCT group ( n = @ ) will be randomly assigned to SG , SG-IVR , or DVD-IRV .


Assessment of primary ( weight loss , reach , & cost ) and secondary ( physical activity , & dietary intake ) outcomes will occur at baseline , @ , @ , and @ months .


This will be the first diabetes prevention trial that will allow the research team to determine the relationships between reach , effectiveness , and cost of different interventions .


Agomelatine was efficacious in reducing symptoms in a short-term placebo-controlled trial in generalized anxiety disorder ( GAD ) and in preventing relapse in a longer term placebo-controlled study .


An additional short-term placebo-controlled study is required by regulatory agencies to confirm the efficacy of agomelatine in GAD .


This @-week , placebo-controlled , double-blind , randomized , parallel group , international , multicenter study was designed to confirm the efficacy of agomelatine @-@ mg/d in the treatment of patients with a primary DSM-IV-TR diagnosis of GAD .


The primary outcome measure was the Hamilton Anxiety Rating Scale ( HARS ) total score .


Assay sensitivity was evaluated by including an escitalopram ( @-@ mg/d ) group .


The study was undertaken in @ clinical centers in Argentina , Czech Republic , Finland , South Korea , Poland , Russia , and Slovakia from April @ to July @ .


One hundred thirty-nine outpatients were included in the agomelatine group , @ in the placebo group , and @ in the escitalopram group .


Agomelatine significantly reduced mean ( SD ) HARS total score ( agomelatine-placebo difference : @ -LSB- @ -RSB- , P < @ ) and had significant effects on secondary outcome measures , including psychic and somatic HARS subscales , response rate ( estimate -LSB- standard error -RSB- ) ( agomelatine-placebo difference : @ % -LSB- @ % -RSB- , P < @ ) , remission on the HARS ( agomelatine-placebo difference : @ % -LSB- @ % -RSB- , P = @ ) , Clinical Global Impressions-Severity of Illness scale ( CGI-S ) ( P < @ ) , functional impairment ( P < @ ) , and sleep quality ( P < @ ) .


Findings were confirmed in the subset of more severely ill patients ( HARS total score @ with or without CGI-S @ at baseline ) .


Agomelatine was well tolerated by patients , with no more adverse events than placebo .


Escitalopram was similarly efficacious but was accompanied by a higher incidence of adverse events compared to placebo .


In clinical practice , agomelatine has at least similar efficacy to that of escitalopram for the short-term treatment of GAD and is well tolerated .


Photodynamic therapy ( PDT ) is followed by significant inflammation .


Protoporphyrin ( Pp ) IX is still formed in the skin after PDT and patients are sensitive to daylight @-@ h after treatment .


Exposure to daylight after PDT may therefore increase inflammation .


To investigate whether protection with inorganic sunscreen , foundation or light-blocking plaster after PDT can reduce inflammation caused by daylight-activated PpIX .


On the right arm of @ subjects with sun-damaged skin , four identical squares ( @ @ cm ) were given conventional PDT treatment .


Immediately after red-light illumination the squares were either left unprotected or protected by inorganic sunscreen -LSB- sun protection factor ( SPF ) @ -RSB- , foundation ( SPF@ ) or light-blocking plaster .


The skin was then illuminated with artificial daylight for @ h and afterwards covered for @ h. Fluorescence and erythema ( inflammation ) were measured with a fluorescence camera and a reflectance meter .


PpIX was significantly reduced after artificial daylight illumination ( P < @ ) , except on the square protected with light-blocking silver plaster , where it had increased ( P = @ ) .


The increased erythema @ h after treatment was reduced by @ % with the sunscreen ( P = @ ) , by @ % with the foundation ( P = @ ) and by @ % with the silver plaster ( P = @ ) .


Artificial daylight exposure after conventional PDT increases skin erythema .


Light-blocking plaster gives more effective protection against post-PDT daylight exposure than inorganic sunscreen and foundation .


In practice such full protection can be achieved by use of sun-blocking clothes or daylight avoidance for @ h.


Less than half of breast cancer survivors with lymphedema perform self-care as directed .


Effective lymphedema self-care is required to obtain acceptable health outcomes .


Self-Regulation Theory suggests that objective self-measurement of physiological conditions is necessary to promote self-regulation/self-care .


Bioelectric Impedance Spectroscopy ( BIS ) represents a potential self-measurement method for arm lymphedema .


The purpose of this pilot study was to examine the impact of arm self-measurement on daily self-care activities and health outcomes in breast cancer survivors with lymphedema .


A pilot randomized clinical trial compared outcomes between breast cancer survivors with lymphedema who self-monitored for @ months and breast cancer survivors with lymphedema who did not self-monitor .


Data were collected at baseline , months @ , @ , @ , and @ .


Eighty-six women with lymphedema were screened : @ were eligible , @ were enrolled , @ withdrew , and @ had incomplete data , thus N = @ .


No between group differences were noted in participant characteristics .


The self-monitored group had higher days of garment use ( p = @ ) that remained stable after self-monitoring stopped .


The median number of days of simple manual lymphatic drainage increased in the intervention group ( p = @ ) with a downward trend after self-monitoring ceased .


Objective self-monitoring of arms using BIS is possible .


Self-monitoring may positively impact self-care behaviors .


Highly symptomatic patients may require coaching or other psychological support to improve their self-care .


Studies that combine a cognitive behavioral therapy component along with self-measurement should be considered as potential interventions to impact lymphedema self-care .


Other applications of self-monitoring warrant investigation .


To determine whether the application of occlusive wrap applied immediately after birth will reduce mortality in very preterm infants .


This was a prospective randomized controlled trial of infants born @@/@ to @@/@ weeks ' gestation who were assigned randomly to occlusive wrap or no wrap .


The primary outcome was all cause mortality at discharge or @ months ' corrected age .


Secondary outcomes included temperature , Apgar scores , pH , base deficit , blood pressure and glucose , respiratory distress syndrome , bronchopulmonary dysplasia , seizures , patent ductus arteriosus , necrotizing enterocolitis , gastrointestinal perforation , intraventricular hemorrhage , cystic periventricular leukomalacia , pulmonary hemorrhage , retinopathy of prematurity , sepsis , hearing screen , and pneumothorax .


Eight hundred one infants were enrolled .


There was no difference in baseline population characteristics .


There were no significant differences in mortality ( OR @ , @ % CI @-@ @ ) .


Wrap infants had statistically significant greater baseline temperatures ( @ C wrap vs @ C no wrap , P < @ ) and poststabilization temperatures ( @ C vs @ C , P < @ ) than nonwrap infants .


For the secondary outcomes , there was a significant decrease in pulmonary hemorrhage ( OR @ , @ % CI @-@ @ ) in the wrap group and a significant lower mean one minute Apgar score ( P = @ ) in the wrap group .


The study was stopped early because continued enrollment would not result in the attainment of a significant difference in the primary outcome .


Application of occlusive wrap to very preterm infants immediately after birth results in greater mean body temperature but does not reduce mortality .


Nondisabling cerebrovascular events represent the largest group of cerebrovascular disease with a high risk of recurrent stroke .


A recent trial demonstrated that dual-antiplatelet therapy ( clopidogrel and aspirin ) , compared with aspirin monotherapy , reduced the risk of recurrent stroke and was not associated with increased risk of hemorrhagic events .


Apixaban , a new oral anticoagulant , has been proven to be as safe and effective as traditional anticoagulants while carrying significantly less risk of intracranial hemorrhage .


Patients with transient ischemic attack ( TIA ) / minor stroke might benefit from apixaban treatment ; therefore , an adequately powered randomized study is needed .


The ADANCE -LSB- Apixaban Versus Dual-antiplatelet Therapy ( Clopidogrel and Aspirin ) in Acute Non-disabling Cerebrovascular Events -RSB- study is a randomized , double-blind clinical trial with a target enrollment of @,@ patients .


A @-day regimen of apixaban or of clopidogrel with aspirin followed by clopidogrel on days @ through @ will be administered to randomized participants with acute TIA or minor ischemic stroke .


The primary efficacy endpoint is the percentage of patients with any new stroke ( ischemic or hemorrhage ) , including fatal stroke , at day @ .


Study visits will be performed on the day of randomization , and at days @ , @ , and @ .


The novel oral anticoagulant apixaban has been widely used with fewer adverse effects than traditional anticoagulants .


We designed the ADANCE trial to observe the effects of apixaban on recurrent stroke after TIA or minor stroke .


The results should better guide the selection of anticoagulant or dual-antiplatelet therapy for patients with acute TIA or minor ischemic stroke .


This study aimed to evaluate the identification rate and surgery time of sentinel lymph node biopsy ( SLNB ) by a multimodal method ( MMM ) using a mixture of indocyanine green ( ICG ) , radioisotope ( RI ) , and blue dye ( BD ) compared with the RI alone .


In this phase II randomized study , @ patients with clinically node-negative breast cancer were enrolled and received SLNB with either MMM or RI .


We compared the identification rate , number of sentinel lymph nodes ( SLNs ) , and detection time of SLNB and evaluated the safety .


The mean age of the MMM group and RI group was @ and @ years ( p = @ ) , respectively .


There were no differences in histopathologic factors , including tumor size , node positivity , and hormone receptor positivity between groups .


SLNs were identified in all patients of both groups ( @ % in the MMM group and @ % in the RI group ) .


The average number of SLNs in the MMM group was more than that in the RI group ( @ @ vs. @ @ , respectively ; p < @ ) .


The time to detect the first sentinel lymph node was similar in each group ( @ @ vs. @ @ min ; p = @ ) .


In the MMM group , percutaneous lymphatic drainage was visualized by fluorescent imaging in @ % ( @ of @ patients ) .


During and after the operation , there were no complications , including allergic reactions , skin staining , or necrosis .


This study is the first randomized trial that compared MMM using ICG , RI , and BD and the conventional RI method for SLNB .


MMM is a feasible and safe method for SLNB .


Glucose measurement in intensive care medicine is performed intermittently with the risk of undetected hypoglycemia .


The workload for the ICU nursing staff is substantial .


Subcutaneous continuous glucose monitoring ( CGM ) systems are available and may be able to solve some of these issues in critically ill patients .


In a randomized controlled design in a mixed ICU in a teaching hospital we compared the use of subcutaneous CGM with frequent point of care ( POC ) to guide insulin treatment .


Adult critically ill patients with an expected stay of more than @ hours and in need of insulin therapy were included .


All patients received subcutaneous CGM .


CGM data were blinded in the control group , whereas in the intervention group these data were used to feed a computerized glucose regulation algorithm .


The same algorithm was used in the control group fed by intermittent POC glucose measurements .


Safety was assessed with the incidence of severe hypoglycemia ( < @ mmol/L ) , efficacy with the percentage time in target range ( @ to @ mmol/L ) .


In addition , we assessed nursing workload and costs .


In this study , @ patients were randomized to the intervention and @ to the control group .


CGM device failure resulted in @ and @ patients for analysis .


The incidence of severe glycemia and percentage of time within target range was similar in both groups .


A significant reduction in daily nursing workload for glucose control was found in the intervention group ( @ versus @ minutes ; P < @ ) .


Mean daily costs per patient were significantly reduced with EUR @ ( @ % CI -@ to -@ , P = @ ) in the intervention group .


Subcutaneous CGM to guide insulin treatment in critically ill patients is as safe and effective as intermittent point-of-care measurements and reduces nursing workload and daily costs .


A new algorithm designed for frequent measurements may lead to improved performance and should precede clinical implementation .


Regular exercise and dietary practices have been shown to affect the health-related quality of life ( HRQOL ) and survival of breast cancer patients .


The current study aimed to investigate whether the WSEDI was a feasible and primarily effective method for promoting exercise and dietary behaviours for breast cancer patients .


A @-week randomized , controlled trial .


Oncology outpatient treatment clinics at @ university hospitals and @ National Cancer Center in South Korea .


Fifty-nine breast cancer patients who had received curative surgery and completed primary cancer treatment within @ months prior to the study and who had been diagnosed with stage @-III cancers within @ years prior to the study were recruited .


Participants were randomly assigned to either the intervention group , which used a Web-based self-management exercise and diet intervention program incorporating transtheoretical model ( TTM ) - based strategies ( n = @ ) , or to the control group , which used a @-page educational booklet on exercise and diet ( n = @ ) .


The intervention efficacy was measured at the baseline and @ weeks via a Web-based survey that addressed the promotion of exercise and consumption of @ servings of fruits and vegetables ( F&V ) per day , dietary quality , HRQOL , anxiety , depression , fatigue , motivational readiness , and self-efficacy .


The proportion of subjects who performed at least moderate-intensity aerobic exercise for at least @ min per week ; ate @ servings of F&V per day ; and had overall improvements in dietary quality , physical functioning and appetite loss ( HRQOL ) , fatigue , and motivational readiness was greater in the intervention group than in the control group .


The self-efficacy with respect to exercise and F&V consumption was greater in the intervention group than in the control group .


A Web-based program that targets changes in exercise and dietary behaviours might be effective for breast cancer survivors if the TTM theory has been used to inform the program strategy , although further research with a larger sample size is required to enable definitive conclusions .


Fidelity assessments are integral to intervention research but few published trials report these processes in detail .


We included plans for fidelity monitoring in the design of a community-based intervention trial .


The study design was a randomized clinical trial of an intervention provided to low-income women to increase utilization of dental care during pregnancy ( mother ) or the postpartum ( child ) period .


Group assignment followed a @ @ factorial design in which participants were randomly assigned to receive either brief Motivational Interviewing ( MI ) or Health Education ( HE ) during pregnancy ( prenatal ) and then randomly reassigned to one of these groups for the postpartum intervention .


The study setting was four county health departments in rural Oregon State , USA .


Counseling was standardized using a step-by-step manual .


Counselors were trained to criteria prior to delivering the intervention and fidelity monitoring continued throughout the implementation period based on audio recordings of counselor-participant sessions .


The Yale Adherence and Competence Scale ( YACS ) , modified for this study , was used to code the audio recordings of the counselors ' delivery of both the MI and HE interventions .


Using Interclass Correlation Coefficients totaling the occurrences of specific MI counseling behaviors , ICC for prenatal was @ , for postpartum the ICC was @ .


Participants provided a second source of fidelity data .


As a second source of fidelity data , the participants completed the Feedback Questionnaire that included ratings of their satisfaction with the counselors at the completion of the prenatal and post-partum interventions .


Coding indicated counselor adherence to MI protocol and variation among counselors in the use of MI skills in the MI condition .


Almost no MI behaviors were found in the HE condition .


Differences in the length of time to deliver intervention were found ; as expected , the HE intervention took less time .


There were no differences between the overall participants ' satisfaction ratings of the HE and MI sessions by individual counselor or overall ( p > @ ) .


Trial design , protocol specification , training , and continuous supervision led to a high degree of treatment fidelity for the counseling interventions in this randomized clinical trial and will increase confidence in the interpretation of the trial findings .


We investigated clinical characteristics and outcomes of patients with significant valvular disease ( SVD ) in the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) trial .


ROCKET AF excluded patients with mitral stenosis or artificial valve prostheses .


We used Cox regression to adjust comparisons for potential confounders .


Among @ @ patients , @ ( @ % ) had SVD ; they were older and had more comorbidities than patients without SVD .


The rate of stroke or systemic embolism with rivaroxaban vs. warfarin was consistent among patients with SVD -LSB- @ vs. @ % ; hazard ratio ( HR ) @ , @ % confidence interval ( CI ) @-@ @ -RSB- and without SVD ( @ vs. @ % ; HR @ , @ % CI @-@ @ ; interaction P = @ ) .


However , rates of major and non-major clinically relevant bleeding with rivaroxaban vs. warfarin were higher in patients with SVD ( @ % rivaroxaban vs. @ % warfarin ; HR @ , @ % CI @-@ @ ) vs. those without ( @ % rivaroxaban vs. @ % warfarin ; HR @ , @ % CI @-@ @ ; interaction P = @ ) , even when controlling for risk factors and potential confounders .


In intracranial haemorrhage , there was no interaction between patients with and without SVD where the overall rate was lower among those randomized to rivaroxaban .


Many patients with ` non-valvular atrial fibrillation ' have significant valve lesions .


Their risk of stroke is similar to that of patients without SVD after controlling for stroke risk factors .


Efficacy of rivaroxaban vs. warfarin was similar in patients with and without SVD ; however , the observed risk of bleeding was higher with rivaroxaban in patients with SVD but was the same among those without SVD .


Atrial fibrillation patients with and without SVD experience the same stroke-preventive benefit of oral anticoagulants .


Burnout syndrome is an important health problem that affects many professionals and must be addressed globally , with both organizational measures and personal interventions .


Burnout of health professionals can be prevented in order to avoid personal , familial , and social consequences , as well as repercussions for patients .


This work describes a protocol for a controlled , pragmatic , randomized clinical trial in @ parallel groups : intervention and control .


All health professionals from @ health care centers will form the intervention group , and all health professionals from @ different health care centers will form the control group .


The intervention group will receive @ hours of training at their work place .


The Maslach 's burnout inventory , the Cuestionario de Desgaste Profesional Mdico or the Cuestionario de Desgaste Profesional de Enfermera , and the @-item Goldberg 's General Health Questionnaire , validated for our setting , will be used as measurement tools .


Change in the average scores from the Maslach 's burnout inventory emotional exhaustion scale will be compared between the intervention and control groups , measured as intention-to-treat , and the intervention will be considered effective if a minimum decrease of @ % is achieved .


Due to the deleterious consequences of burnout syndrome for people suffering from it and for the organization where they work , it is necessary to evaluate the effectiveness of certain interventions for its prevention .


Organizational measures are important for preventing burnout syndrome , but so is providing professionals with coping strategies , as this group intervention intends to do .


To evaluate whether administration of analgesic medication one hour before undergoing office hysteroscopy decreased pain and other side effects .


A prospective randomized study was carried out in @ patients who underwent office hysteroscopy from November @ until May @ patients received @mg paracetamol and @mg ibuprofen one hour before the procedure and @ did not receive any medication .


We observed significant differences ( p = @ ) regarding the occurrence of non-pain side effects , @ % in the non-medicated group and none of the patients in the medicated group .


The main pain score was always slightly higher in the group receiving no medication , though there was no statistically significant difference when compared to the medicated group .


Administration of @g paracetamol and @mg ibuprofen one hour prior to office hysteroscopy decreased statistically the occurrence of non-pain side effects such as nausea , emesis , and hypotension .


No differences in pain scores were observed .


Vitamin D promotes bone health and regulates the immune system , both important actions for pediatric patients with inflammatory bowel disease ( IBD ) .


The supplementation dose that would maintain optimal serum @-hydroxyvitamin D concentration ( @OHD @ ng/mL ) is unknown .


The objective of the study was to compare two supplementation regimens ' efficacy and safety in maintaining optimal @OHD in children with IBD .


This was a randomized , not blinded , controlled trial .


The trial was conducted in the Boston Children 's Hospital Clinical and Translational Study Unit .


Sixty-three patients , aged @-@ years with IBD and baseline @OHD greater than @ ng/mL were enrolled ; @ completed the study , and one withdrew for adverse events .


Arm A received @ IU of oral vitamin D@ daily ( n = @ ) .


Arm B received @ IU daily in the summer/fall and @ IU in the winter/spring ( n = @ ) .


The main outcome was the probability of maintaining @OHD of @ ng/mL or greater in all trimonthly visits for @ months .


Three participants in arm A ( @ % ) and three in arm B ( @ % ) achieved the primary outcome ( P = @ ) .


The incidence of adverse events , all minor , did not differ .


More participants in arm A developed C-reactive protein level of @ mg/dL or greater ( @ % vs @ % , P = @ ) and IL-@ greater than @ pg/mL ( @ % vs @ % , P = @ ) .


Daily oral vitamin D@ doses up to @ IU were inadequate to maintain optimal @OHD but were well tolerated .


The finding of lower incidence of elevated inflammatory markers and cytokines among participants receiving higher vitamin D@ doses merits further study .


In the clinic setting both fasting levels of glucose and the area under the curve ( AUC ) of glucose , by determination of HbA@c levels , are used for risk assessments , in type @ diabetes ( NIDDM ) .


However little is known about postprandial levels , and hence AUC , regarding other traditional risk factors such as insulin and blood-lipids and how this is affected by different diets .


To study postprandial effects of three diets , during a single day , in NIDDM .


A low-fat diet ( @-@ energy - % from carbohydrates ) , and a low-carbohydrate diet ( @-@ energy - % from carbohydrates ) was compared with a Mediterranean-style diet ( black coffee for breakfast and the same total-caloric intake as the other two diets for lunch with red wine , @-@ energy - % from carbohydrates ) in a randomized cross-over design .


Total-caloric intake/test-day at the clinic from food was @-@ kCal in men and @-@ kCal in women .


The test meals were consumed at a diabetes ward under supervision .


Twenty-one participants were recruited and @ completed the studies .


The low-carbohydrate diet induced lower insulin and glucose excursions compared with the low-fat diet ( p < @ for both AUC ) .


The insulin-response following the single Mediterranean-style lunch-meal was more pronounced than during the low-fat diet lunch ( insulin increase-ratio of the low-fat diet : @ @ , of Mediterranean-style diet : @ @ , p = @ ) while postprandial glucose levels were similar .


The increase-ratio of insulin correlated with the elevation of the incretin glucose-dependent insulinotropic-polypeptide following the Mediterranean-style diet lunch ( Spearman , r = @ , p = @ ) .


The large Mediterranean-style lunch-meal induced similar postprandial glucose-elevations as the low-fat meal despite almost double amount of calories due to a pronounced insulin-increase .


This suggests that accumulation of caloric intake from breakfast and lunch to a single large Mediterranean style lunch-meal in NIDDM might be advantageous from a metabolic perspective .


In the Eplerenone in Mild Patients Hospitalization and Survival Study in Heart Failure ( EMPHASIS-HF ) , aldosterone blockade with eplerenone decreased mortality and hospitalisation in patients with mild symptoms ( New York Heart Association class II ) and chronic systolic heart failure ( HF ) .


The present study evaluated the cost-effectiveness of eplerenone in the treatment of these patients in the UK and Spain .


Results from the EMPHASIS-HF trial were used to develop a discrete-event simulation model estimating lifetime direct costs and effects ( life years and quality-adjusted life years ( QALYs ) gained ) of the addition of eplerenone to standard care among patients with chronic systolic HF and mild symptoms .


Eplerenone plus standard care compared with standard care alone increased lifetime direct costs per patient by @ for the UK and @ for Spain , with additional quality-adjusted life expectancy of @ QALYs for the UK and @ QALYs for Spain .


Mean lifetime costs were @ per QALY in the UK and @ per QALY in Spain .


Probabilistic sensitivity analysis suggested a @ % likelihood of eplerenone being regarded as cost-effective at a willingness-to-pay threshold of @ per QALY ( UK ) or @ per QALY ( Spain ) .


By currently accepted standards of value for money , the addition of eplerenone to optimal medical therapy for patients with chronic systolic HF and mild symptoms is likely to be cost-effective .


To assess the impact of anemia and iron deficiency on health-related quality of life ( HRQoL ) in women treated for heavy menstrual bleeding ( HMB ) .


Secondary analysis of a randomized controlled trial .


Five university hospitals in Finland .


A total of @ women referred for HMB .


Women were randomized to treatment with hysterectomy or a levonorgestrel-releasing intrauterine system .


We defined groups based on women 's pretreatment hemoglobin -LSB- hemoglobin < @g/L ( anemic ) vs. hemoglobin @g/L ( nonanemic ) -RSB- and serum ferritin ( ferritin < @g/L vs. @g/L ) concentrations .


HRQoL was compared between groups at baseline , @ and @months after treatment .


Hemoglobin and ferritin were followed for @years .


HRQoL was measured by the RAND @-item health survey ( RAND-@ ) , @-Dimensional EuroQol and two questionnaires of mental wellbeing .


At baseline , @ women ( @ % ) were anemic and @ ( @ % ) were severely iron deficient ( ferritin < @g/L ) .


Only @ % of the anemic women had taken iron supplementation .


Twelve months after treatment hemoglobin had increased in both hemoglobin groups , but was still significantly lower ( p < @ ) in initially anemic women ( @g/L ) compared with nonanemic women ( @g/L ) .


Twelve months after treatment three domain scores of RAND-@ increased more ( energy , p = @ ; physical functioning , p = @ ; social functioning , p = @ ) , and anxiety ( p = @ ) and depression scores ( p = @ ) decreased more in anemic compared with nonanemic women .


Serum ferritin took @years to reach normal levels .


Improved HRQoL after treatment of HMB is associated with correction of anemia .


Clinicians should actively screen for anemia in women with HMB and emphasize early iron substitution as an integral part of treatment .


People with diabetes frequently develop vascular disease .


We investigated the relationship between blood @-hydroxyvitamin D ( @OH-D ) concentration and vascular disease risk in type @ diabetes .


The relationships between blood @OH-D concentration at baseline and the incidence of macrovascular ( including myocardial infarction and stroke ) and microvascular ( retinopathy , nephropathy , neuropathy , and amputation ) disease were analyzed with Cox proportional hazards models and logistic regression in an observational study of patients in the @-year Fenofibrate Intervention and Event Lowering in Diabetes trial .


A total of @ % of the patients had low vitamin D concentrations , as indicated by median blood @OH-D concentration of @ nmol/L .


These patients with a blood @OH-D concentration < @ nmol/L had a higher cumulative incidence of macrovascular and microvascular events than those with levels @ nmol/L .


Multivariate analysis , stratified by treatment and adjusted for relevant confounders , identified blood @OH-D concentration as an independent predictor of macrovascular events .


A @ nmol/L difference in blood @OH-D concentration was associated with a @ % ( P = @ ) change in risk of macrovascular complications during the study , and further adjustments for seasonality , hs-CRP , and physical activity level had little impact .


The unadjusted risk of microvascular complications was @ % ( P = @ ) higher during the study , though the excess risk declined to @-@ % and lost significance with adjustment for HbA@c , seasonality , or physical activity .


Low blood @OH-D concentrations are associated with an increased risk of macrovascular and microvascular disease events in type @ diabetes .


However , a causal link remains to be demonstrated .


Asthma clinical guidelines suggest written asthma action plans are essential for improving self-management and outcomes .


To assess the efficacy of written instructions in the form of a written asthma action plan provided by subspecialist physicians as part of usual asthma care during office visits .


A total of @ children and adults with persistent asthma receiving first-time care in pulmonary and allergy practices at @ urban medical centers were randomized to receive either written instructions ( n = @ ) or no written instructions other than prescriptions ( n = @ ) from physicians .


Using written asthma action plan forms as a vehicle for providing self-management instructions did not have a significant effect on any of the primary outcomes : ( @ ) asthma symptom frequency , ( @ ) emergency visits , or ( @ ) asthma quality of life from baseline to @-month follow-up .


Both groups showed similar and significant reductions in asthma symptom frequency ( daytime symptoms -LSB- P < @ -RSB- , nocturnal symptoms -LSB- P < @ -RSB- , - agonist use -LSB- P < @ -RSB- ) .


There was also a significant reduction in emergency visits for the intervention ( P < @ ) and control ( P < @ ) groups .


There was significant improvement in asthma quality-of-life scores for adults ( P < @ ) and pediatric caregivers ( P < @ ) .


Our results suggest that using a written asthma action plan form as a vehicle for providing asthma management instructions to patients with persistent asthma who are receiving subspecialty care for the first time confers no added benefit beyond subspecialty-based medical care and education for asthma .


Clinical trial registered with www.clinicaltrials.gov ( NCT @ ) .


Gentamicin is used as a therapeutic agent for Mnire 's disease because of its vestibulotoxicity causing chemo-ablation of the vestibular sensory epithelia .


Its use has increased in recent years .


However , there is still no consensus about the dose regimen of gentamicin in the treatment of Mnire 's disease .


In this study two different dose regimen treatment protocols are compared in a placebo controlled study design .


The primary objective is to quantify the treatment effect on dizziness , the secondary objective is hearing evaluation .


We performed a randomized , double-blind , placebo-controlled study in adults with unilateral Mnire 's disease according to the AAO-HNS guidelines resistant to conservative medication .


Three groups received four injections , administered weekly ( four intratympanic injections with @mg/mL gentamicin solution , two injections gentamicin solution and two injections of placebo in random order , or four injections with placebo ) .


Outcome measures were the score on the Dizziness Handicap Inventory and pure tone audiometry ( PTA ) .


Intended follow-up was @years .


During follow-up one patient exceeded the accepted amount of hearing loss .


Further , enrollment was very slow ( until @months between two patients ) and new insights showed an apparent benefit of intratympanic gentamicin treatment ( ITG ) .


Therefore we performed an unscheduled interim analysis which showed that PTA threshold shifts reached the stopping criteria in two more patients .


Because of this , this study was ended .


Of the three patients with the significant PTA threshold shift two were enrolled in the gentamicin group .


No conclusions can be drawn concerning doses regimens .


Now that new publications have shown that ITG treatment can be an effective and safe treatment , a placebo-controlled randomized controlled trial may not pass the ethical committee because of these recent reports in literature .


Still , a dose regimen study ( without placebo ) on ITG treatment needs to be performed .


The purpose of this study was to investigate whether the availability of both dextroamphetamine and methylphenidate provides an opportunity to minimize adverse events in a pediatric attention-deficit/hyperactivity disorder ( ADHD ) stimulant trial .


Thirty-six medication-nave children @-@ years of age , diagnosed with ADHD , were enrolled for @ weeks in a crossover trial , with @ weeks of methylphenidate , dextroamphetamine , and a placebo in a randomly assigned , counterbalanced sequence .


Barkley 's Side-Effect Rating Scale ( SERS ) , rated by parents , was used to assess adverse events .


SERS were available for @ children , and data were analyzed both at the group and the single-subject level .


The side-effect profiles of dextroamphetamine and methylphenidate appeared similar at the group level .


Overall , insomnia and decreased appetite were the only adverse events associated with the stimulants as compared with placebo .


No significant increase from placebo to stimulant conditions was detected on SERS items reflecting emotional symptoms .


Furthermore , dextroamphetamine and methylphenidate did not differ from each other on any SERS item , except that dextroamphetamine was associated with higher severity of `` insomnia '' and a higher prevalence of `` unusually happy . ''


Single-subject analyses showed that one or more adverse events were reported in @ children ( @ % ) , and were evenly distributed between those with dextroamphetamine as the drug that showed the greatest reduction in their ADHD symptoms ( `` best drug '' ) and those with methylphenidate as their best drug .


Among children in whom both stimulants were associated with a decrease in ADHD symptoms , a clinically valid difference between the two stimulants in total adverse events score was found in @ ( @ % ) of the @ cases .


In these children , the availability of both stimulants provided an opportunity to minimize adverse events , while maintaining a reduction in ADHD symptoms .


The availability of both dextroamphetamine and methylphenidate may contribute to minimize adverse events in a subsample of children in pediatric ADHD stimulant trials .


Optimal starting point for antiretroviral treatment ( ART ) has been uncertain .


Parallel group , single blind , randomised controlled study of adult HIV positive patients consulting at the Protestant Hospital , Ngaoundere , Cameroon in @-@ .


Simple randomisation of patients in WHO clinical stage @-@ to start of ART early or deferred , i.e. when CD@ counts dropped below @ versus @ cells/mm ( @ ) , or when they reached clinical stage @-@ .


Clinical follow-up every three months were offered for all patients .


Main outcomes were clinical stage , CD@ differences and mortality .


Of @ consulting patients , most were excluded , mainly because they were already in WHO stage @-@ .


Forty-four patients were randomised .


In the ` early ' group two patients died and five were lost to follow-up .


In the ` deferred ' group , six patients died and nine were lost to follow-up ( Hazard ratio for death by early compared to deferred treatment @ , @ % confidence interval @-@ @ ) .


Of the patients lost to follow-up , three patients in the ` early ' group and four patients in the ` deferred ' group were known to be alive when the study ended .


Fourteen patients in the early group and @ in the deferred group started ART .


Twenty-two patients were evaluated clinically six to seven months after the study period was terminated .


Except for one patient with AIDS , these were all still in clinical stage @-@ .


In our small sample , relative risk for death did not differ significantly , but deferred treatment seemed to carry no increased survival or other clinical advantage .


During the study period , other studies made WHO change its guidelines to conform to our early treatment .


The tendency in our study lends support to this policy .


To determine whether tumor grade , molecular subtype and hypoxia predict response to hypofractionated versus standard radiotherapy ( RT ) following breast-conserving surgery ( BCS ) for node-negative breast cancer in a randomized controlled trial ( RCT ) .


Formalin-fixed paraffin-embedded ( FFPE ) tumor blocks were available on @ of @ patients enrolled in the Hypofractionation Whole Breast Irradiation ( HWBI ) Trial .


A central pathology review and assessment of tumor grade using the Nottingham grading system was carried out .


Tumors were classified by molecular subtype as luminal A , luminal B , HER@ enriched , basal-like or unclassified using a six-biomarker panel ; ER , PR , HER-@ , Ki@ , CK@/@ and EGFR .


Tumors were also classified as hypoxic based on the expression of HIF@ , CAIX or GLUT-@ .


The primary end point was local recurrence ( LR ) .


Median follow-up was @ years .


In the multivariable Cox model , molecular subtype was the only factor predictive of LR , the @-year cumulative incidence was @ % for luminal A and basal-like , @ % for luminal B and @ % for HER-@ enriched tumors ( P < @ ) .


Tumor grade , molecular subtype or hypoxia did not predict response to hypofractionation .


In women enrolled in the HWBI trial following BCS tumor molecular subtype predicted LR .


However tumor grade , molecular subtype and hypoxia did not predict response to hypofractionation suggesting that patients with node-negative breast tumors of all grades and molecular subtypes may be safely treated with hypofractionated RT regimens .


To compare the efficacy of etanercept ( ETN ) and methotrexate ( MTX ) versus MTX monotherapy for remission induction in patients with early inflammatory arthritis .


In a @-week multicentre randomised placebo-controlled superiority trial , @ DMARD-nave patients with early clinical synovitis ( @ tender and swollen joint , and within @ months of diagnosis ) and either rheumatoid factor , anticitrullinated protein antibodies or shared epitope positive were randomised @:@ to receive MTX+ETN or MTX + placebo ( PBO ) for @ weeks .


Injections ( ETN or PBO ) were stopped in all patients at week @ .


In those with no tender or swollen joints ( NTSJ ) for > @ weeks , injections were stopped early .


If patients had NTSJ > @ weeks after stopping the injections , MTX was weaned .


The primary endpoint was NTSJ at week @ .


No statistically significant difference was seen for the primary endpoint ( NTSJ at week @ ( @ % vs @ % -LSB- adjusted OR @ ( @ to @ ) , p = @ -RSB- ) in the MTX+ETN and MTX+PBO groups , respectively ) .


The secondary endpoints did not differ between groups at week @ or @ .


Exploratory analyses showed a higher proportions of patients with DAS@-CRP < @ in the MTX+ETN group at week @ ( @ % vs @ % , adjusted OR @ ( @ to @ ) , p = @ ) and week @ ( @ % vs @ % , adjusted OR @ ( @ to @ ) , p = @ ) .


In this group of patients with early inflammatory arthritis , almost a third had no tender , swollen joints after @ year .


MTX+ETN was not superior to MTX monotherapy in achieving this outcome .


Clinical responses , however , including DAS@-CRP < @ , were achieved earlier with MTX+ETN combination therapy .


Selective serotonin reuptake inhibitors ( SSRI ) and serotonin-norepinephrine reuptake inhibitors ( SNRI ) are effective in treating anxiety disorders associated with major depressive disorder ( MDD ) .


This randomized , controlled , parallel-group , open-label , phase @ trial ( CTRI/@/@ / @ ) was undertaken to compare the effectiveness and safety of desvenlafaxine versus escitalopram , a standard antidepressant .


Effectiveness was assessed using the Hamilton Depression Rating Scale ( HAM-D@ ) and Hamilton Anxiety Rating Scale ( HAM-A ) .


Response to treatment was assessed by @ % decrease of baseline scores ( responder rate ) .


Safety and tolerability was evaluated by changes in routine laboratory parameters , vital signs , and adverse events reported by the subject and/or observed by the clinician .


Responder rates for both HAM-A and HAM-D scores at @ weeks were better in the escitalopram group compared to the desvenlafaxine group ( HAM-A @ % vs. @ % ; HAM-D @ % vs @ % ) but the differences were not statistically significant ( P = @ and P = @ ) .


Within group changes of both scores , from baseline to subsequent visits in both treatment arms were statistically significant ( P < @ ) .


The effectiveness of desvenlafaxine was comparable to escitalopram , but escitalopram was better tolerated .


To examine if a small token monetary incentive ( NZ$ @ ) increases mail survey response rates and participant retention of @-@ year old New Zealand women .


In @ , @ women were randomly selected from the New Zealand electoral rolls for a prospective study investigating factors related to the prevention of weight gain .


At baseline , @ women were randomly assigned to receive NZ$ @ with the initial survey mail-out in addition to nonmonetary gifts to encourage participation ( pen , tea bag , entry in lottery draw ) received by all women .


At @ years , @ women ( @ received NZ$ @ at baseline and @ had not ) were randomly assigned to receive the same token monetary incentive .


At @ years , all women identifying as an ethnic minority ( n = @ ) and @ randomly selected women of other ethnicities received the token monetary incentive with the initial mail out .


The baseline response rate for women who received NZ$ @ was significantly higher than for women who did not ( @ % vs @ % , p < @ ) .


At @ years , retention rate for all women who received NZ$ @ was significantly higher than for women who did not ( @ % vs @ % , p < @ ) .


At @ years , among those women not identifying as an ethnic minority , the retention rate for those who received NZ$ @ was significantly higher than for those who did not ( @ % vs @ % , p = @ ) .


Inclusion of a small token monetary incentive significantly increases mail survey response rates and participant retention in mid-age New Zealand women .


Co-sleeping is associated with disturbance of the natural sleep pattern , including sleep fragmentation and daytime sleepiness .


Nocturnal enuresis ( NE ) or bed-wetting , although benign , is a significant cause of distress to affected children and their caregiver ( s ) .


This study investigated the relationship between co-sleeping and NE in primary school children from China .


Data from a previous sleep study of primary school children from @ cities across China were analyzed .


Multivariable regression analysis was performed to assess the relationship between co-sleeping and NE while controlling for a number of confounding factors .


The prevalence of NE in co-sleeping and non-co-sleeping children in different age groups was evaluated .


The prevalence of co-sleeping and NE in children aged @ to @ years was @ % and @ % , respectively .


Co-sleeping was associated with a higher prevalence of NE in primary school age children ( odds ratio -LSB- OR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; p < @ ) after adjusting for confounding factors .


The differences in the prevalence of NE between co-sleepers and non-co-sleepers were significant in the @-year age group ( OR , @ ; @ % CI , @-@ @ ; p = @ ) and @ - to @-year age group ( OR , @ ; @ % CI , @-@ @ ; p < @ ) .


Co-sleeping may increase the risk of NE in primary school children , particularly in those aged @ to @ years .


To investigate the effect of nicotine on choroidal thickness using optical coherence tomography ( OCT ) .


Prospective , case-control study .


Sixteen young , healthy subjects and @ age and gender matched control cases were included in this study ; @ mg nicotine gum was given to the study group and placebo gum to the control group .


All participants underwent OCT scanning with a high-speed and resolution spectral-domain OCT device ( @D OCT @ , Topcon , Japan ) at baseline , and @ h following nicotine or placebo administration .


The measurements were taken in the morning ( @:@ -@:@ hours ) to avoid diurnal fluctuation .


The median foveal choroidal thickness at baseline was @ m ( IQR @ ) , which decreased to @ m ( IQR @ ) at @ h following oral nicotine intake ( p = @ ) .


The median choroidal thickness was also significantly decreased at five other extrafoveal points ( p < @ for all ) .


In the control group , the median baseline choroidal thickness at the fovea was @ m ( IQR @ ) , and was @ m ( IQR @ ) at @ h ( p = @ ) .


Nicotine causes a significant decrease in choroidal thickness following oral intake .


This acute decrease might be a result of reduced ocular blood flow due to the vasoconstrictive effect of nicotine .


To describe successful methods of recruitment and identify practice characteristics related to increased recruitment of older people for a randomised controlled trial .


General practices in three regions of New Zealand and community-dwelling patients aged @ + were recruited for the Brief Risk Identification Geriatric Health Tool trial .


General practitioners ( GPs ) were faxed invitations with telephone follow-up .


Reply-paid cards with telephone follow-up were used to invite older people .


GP and practice characteristics were examined in relationship to recruitment rate .


During @-@ , @ of @ GPs ( @ % ) in @ of @ practices approached ( @ % ) were recruited .


Regional variation was marked and @ of @ invited ( @ % ) older people were recruited .


The GP 's length of time at the practice and training in New Zealand was associated with recruitment success .


Despite variability in practice recruitment , a reasonably large and representative sample of older people was recruited through general practices .


Complaints of knee pain secondary to early osteoarthritis may account for up to @ % of visits to primary care physicians .


Due to the proposed inflammatory changes in early osteoarthritis , intra-articular injections of corticosteroids ( IACS ) have been considered as an option for disease progression modification , pain control , and improvement of function .


However , some studies have suggested poor accuracy rates of IA injections depending on the entry site chosen .


It is therefore the aim of this study to evaluate the efficacy of IA knee corticosteroid injection in reducing pain and improving function in patients with early osteoarthritis and whether the low accuracy rates reported with the Anterolateral joint line injection site translate to worse functional and pain outcome measures as compared to Suprapatellar lateral injections .


The study was carried out as an open-label , randomized controlled trial with @ sequential patients recruited .


Simple randomization separated groups into anterolateral joint line or suprapatellar lateral injection sites .


Improvements were measured with WOMAC and VAS scores after injection of Lidocaine and steroid solution .


Patients receiving IACS injections had a measurable improvement in self-reported outcomes as evidenced by standard deviation change in WOMAC and VAS scores .


The majority of patients had a clinically significant improvement in VAS scores as compared to their initial measures with a notable amount of patients improving significantly as well on their WOMAC scores , irrespective of the injection site chosen .


We have therefore continued the use of palpation-guided intra-articular knee injections in an effort to reduce costs as compared to other injection modalities with positive results in our osteoarthritis patients .


Artificial ulcers remain a major complication after Endoscopic submucosal dissection ( ESD ) .


The development of more effective treatment regimen for this ulcer is required than the use of proton pump inhibitor ( PPI ) alone .


Patients with ESD-derived artificial ulcers were randomly assigned to two groups : a group of patients who received rabeprazole @ mg daily for @ weeks ( PPI group ) and a group of patients who received a combination of rebamipide @ mg daily for @ weeks and rabeprazole @ mg dairy for the first @ weeks ( reb + PPI group ) .


The area reduction ratio and healing status of ulcers were evaluated endoscopically on postoperative @ , @ and @ days .


The overall ulcer area reduction ratio was higher in the reb + PPI group than in the PPI group , especially at an early stage .


The ratio of progression to the H@ stage in the reb + PPI group was significantly higher than that in the PPI group , especially at an early stage .


Treatment with @ weeks of rebamipide plus the first @ weeks of PPI demonstrated a reduction ratio of artificial ulcers superior to that with @ weeks of PPI mono-therapy .


This combination treatment is , therefore , one of the candidate treatment strategies against ESD-derived artificial ulcers .


To evaluate the effectiveness of magnetotherapy in the treatment of hand osteoarthritis ( HO ) .


In this randomized controlled single-blind follow-up study , patients with HO were randomly assigned into @ groups ( G@ and G@ ) .


The subjects in G@ ( n = @ ) received @Hz , @ pulse/s , @-@G , magnetotherapy of totally @ days and @ min/day combined with active range of motion/strengthening exercises for the hand .


G@ ( n = @ ) received sham-magnetotherapy for @ min/day for the same duration combined with the same hand exercises .


Outcome measures were pain and joint stiffness evaluation , handgrip and pinchgrip strength ( HPS ) , Duruz and Auscan Hand Osteoarthritis Indexes ( DAOI ) and Short Form-@ Health Questionnaire ( SF-@ ) administered at baseline , immediately after treatment and at the follow up .


When the groups were compared with each other , improvement observed in SF-@ Pain ( p < @ ) , SF-@ Social Function ( p = @ ) , SF-@ Vitality ( p = @ ) , SF-@ General Health ( p = @ ) , Pain at rest ( p < @ ) , Pain at motion ( p < @ ) , Joint stiffness ( p < @ ) , DAOI ( p < @ ) were in favor of G@ .


Changes in pain , function and quality of life scores showed significant advantage in favor of the applied electromagnetic intervention in patients with HO .


To determine the frequency of pharmacogenomic variants and concurrent medications that may alter the efficacy and tolerability of acetylcholinesterase inhibitors ( AChEIs ) .


A multisite cross-sectional study was carried out across four memory care practices in the greater Indianapolis area .


Participants were adults aged @ years and older with a diagnosis of probable or possible Alzheimer 's disease ( AD ) ( n = @ ) .


Blood samples and self-reported medication data were collected .


Since two of the three AChEIs are metabolized by cytochrome P@ ( CYP ) -@ D@ , we determined the frequency of functional genetic variants in the CYP@D@ gene and calculated their predicted CYP@D@-activity scores .


Concurrent medication data were collected from self-reported medication surveys , and their predicted effect on the pharmacokinetics of AChEIs was determined based on their known effects on CYP@D@ and CYP@A@/@ enzyme activities .


Among the @ subjects enrolled , @ % were female and @ % were African American .


Subjects had a mean age of @ years .


The population used a mean of eight medications per day ( prescription and nonprescription ) .


The CYP@D@ activity score frequencies were @ ( @ % ) , @ ( @ % ) , @ ( @ % ) , @-@ @ ( @ % ) , and > @ ( @ % ) .


Nineteen subjects ( @ % ) used a medication considered a strong or moderate inhibitor of CYP@D@ , and eight subjects ( @ % ) used a medication considered a strong or moderate inhibitor of CYP@A@/@ .


In total , @ % of the study population was predicted to have reduced activity of the CYP@D@ or CYP@A@/@ enzymes due to either genetic variants or concomitant medications .


Both pharmacogenetic variants and concurrent drug therapies that are predicted to alter the pharmacokinetics of AChEIs should be evaluated in older adults with AD .


Pharmacogenetic and drug-interaction data may help personalize AD therapy and increase adherence by improving tolerability .


In this study , our goal was to compare intraoperative and postoperative analgesic effects of lornoxicam and fentanyl when added to lidocaine Intravenous Regional Anesthesia ( IVRA ) in a group of outpatients who underwent hand surgery .


This is a double blind randomized study .


A total of @ patients were included , randomized into three groups .


Patients in Group I ( L ) received @mg .


kg ( -@ ) of @ % lidocaine @ mL ; patients in Group II ( LL ) received @mg .


kg ( -@ ) lidocaine @ mL + @ mL lornoxicam ; patients in Group III ( LF ) received @mg .


kg ( -@ ) lidocaine @ mL + @ mL fentanyl .


Our primary outcome was first analgesic requirement time at postoperative period .


Lornoxicam added to lidocaine IVRA increased the sensory block recovery time without increasing side effects and increased first analgesic requirement time at the postoperative period when compared to lidocaine IVRA ( p < @ , p < @ respectively ) and fentanyl added to lidocaine IVRA ( p < @ , p < @ respectively ) .


In addition , we also found that fentanyl decreased tourniquet pain ( p < @ ) when compared to lidocaine but showed similar analgesic effect with lornoxicam ( p > @ ) although VAS scores related to tourniquet pain were lower in fentanyl group .


Lornoxicam added to lidocaine IVRA was not superior to lidocaine IVRA in decreasing tourniquet pain .


Addition of fentanyl to lidocaine IVRA seems to be superior to lidocaine IVRA and lornoxicam added to lidocaine IVRA groups in decreasing tourniquet pain at the expense of increasing side effects .


However , lornoxicam did not increase side effects while providing intraoperative and postoperative analgesia .


Therefore , lornoxicam could be more appropriate for clinical use .


Employing waiting list control designs in psychological and behavioral intervention research may artificially inflate intervention effect estimates .


This exploratory randomized controlled trial tested this proposition in a study employing a brief intervention for problem drinkers , one domain of research in which waiting list control designs are used .


All participants ( N = @ ) were provided with brief personalized feedback intervention materials after being randomly allocated either to be told that they were in the intervention condition and that this was the intervention or to be told that they were in the waiting list control condition and that they would receive access to the intervention in four weeks with this information provided in the meantime .


A total of @ participants ( @ % ) were followed-up after @weeks .


Between-group differences were found in one of four outcomes ( proportion within safe drinking guidelines ) .


An interaction was identified between experimental manipulation and stage of change at study entry such that participant change was arrested among those more ready to change and told they were on the waiting list .


Trials with waiting list control conditions may overestimate treatment effects , though the extent of any such bias appears likely to vary between study populations .


Arguably they should only be used where this threat to valid inference has been carefully assessed .


A substantial proportion of patients with gastro-oesophageal reflux disease ( GERD ) have only a partial response to proton pump inhibitor ( PPI ) therapy .


Prokinetic drugs may improve reflux symptoms by enhancing oesophageal motility and gastric emptying .


To evaluate the effect of revexepride , a novel prokinetic @-hydroxytryptamine type @ ( @-HT@ ) receptor agonist , compared with placebo , in patients with GERD who have a partial response to PPIs .


A phase @b , double-blind , parallel-group study was conducted , in which patients were randomised to one of three revexepride treatment groups ( @ , @ and @ mg three times daily ) or placebo ( @:@:@:@ ratio ) .


Daily e-diary data captured patients ' symptoms over an @-week treatment period .


The primary efficacy outcome was the weekly percentage of regurgitation-free days in the second half of the study ( weeks @-@ ) .


In total , @ patients were randomised and @ received treatment ( mean age @ years ; @ % women ) .


The mean percentage of regurgitation-free days increased from baseline ( range , @-@ @ % ) to week @ ( @-@ @ % ) in all four study arms ; however , there were no statistically significant differences in this change between placebo and the three treatment arms .


No dose-dependent relationship in treatment effect was observed for any of the study endpoints .


The incidence of treatment-emergent adverse events ( TEAEs ) was revexepride dose-dependent .


Only one serious TEAE occurred and none resulted in death .


Revexepride was no more effective than placebo in controlling regurgitation in patients with GERD symptoms partially responsive to PPIs .


Revexepride was well tolerated .


ClinicalTrials.gov Identifier : NCT@ .


Despite improvements in the diagnosis and treatment of depression , primary care provider ( PCP ) discussion regarding suicidal thoughts among patients with depressive symptoms remains low .


To determine whether a targeted depression public service announcement ( PSA ) video or an individually tailored interactive multimedia computer program ( IMCP ) leads to increased primary care provider ( PCP ) discussion of suicidal thoughts in patients with elevated risk for clinical depression when compared to an attention control .


Randomized control trial at five different healthcare systems in Northern California ; two academic , two Veterans Affairs ( VA ) , and one group-model health maintenance organization ( HMO ) .


Eight-hundred sixty-seven participants , with mean age @ ; @ % women , @ % from a racial/ethnic minority group .


The PSA was targeted to gender and socio-economic status , and designed to encourage patients to seek depression care or request information regarding depression .


The IMCP was an individually tailored interactive health message designed to activate patients to discuss possible depressive symptoms .


The attention control was a sleep hygiene video .


Clinician reported discussion of suicidal thoughts .


Analyses were stratified by depressive symptom level ( Patient Health Questionnaire -LSB- PHQ-@ -RSB- score < @ -LSB- mild or lower -RSB- versus @ -LSB- at least moderate -RSB- ) .


Among patients with a PHQ-@ score @ , PCP discussion of suicidal thoughts was significantly higher in the IMCP group than in the control group ( adjusted odds ratio = @ , @ % confidence interval = @ , @ , p = @ ) .


There were no significant effects of either intervention on PCP discussion of suicidal thoughts among patients with a PHQ-@ score < @ .