Inter-rater reliability and construct validity of the measure and impact of the intervention on written policies were assessed .


The measure demonstrated moderate to excellent inter-rater reliability ( Spearman 's r = @ to @ ) and construct validity .


OSNAP was associated with significant increases in standards-based policy statements surrounding snacks ( +@ , p = @ ) , beverages ( +@ , p = @ ) , screen time ( +@ , p = @ ) , family communication ( +@ , p = @ ) , and a summary index of OSNAP goals ( +@ , p = @ ) .


OSNAP demonstrated success in building staff capacity to write health-promoting policy statements .


Future research should focus on determining policy change impact on practices .


Nut consumption has been found to decrease risk of coronary heart disease and diabetes and to promote healthy body weights possibly related to their favorable macronutrient profile .


We therefore assessed the effect of pistachios on postprandial glucose and insulin levels , gut hormones related to satiety and endothelial function .


In this randomized crossover study , @ subjects with metabolic syndrome consumed five study meals over @-@ weeks .


The meals differed in fat type and quantity , but were matched according to available carbohydrates ( CHOs ) .


Three meals had @ g available CHO : white bread ( WB@g ) , white bread , butter and cheese ( WB+B+C h ) and white bread and pistachios ( WB+P ) .


Two meals had @ g available CHO : white bread ( WB@g ) and pistachios ( P ) .


Within each group of available CHO meals , postprandial glucose levels were the highest following the white bread-only meals , and glucose response was significantly attenuated when butter and cheese or pistachios were consumed ( P < @ ) .


Postprandial insulin levels were highest after the WB+B+C h meal ( P < @ ) , but did not differ between the white bread-only and pistachio meals .


Both endothelial function ( reactive hyperemia index ) and arterial stiffness ( augmentation index ) significantly increased after the white bread-only meals compared with the WB+B+C h meal ( all P < @ ) .


Insulin secretagogue levels were higher when butter and cheese or pistachios were consumed than when white bread only was consumed ( P < @ ) .


Compared with white bread , pistachio consumption reduced postprandial glycemia , increased glucagon-like-peptide levels and may have insulin-sparing properties .


These effects could be beneficial for individuals with diabetes and metabolic syndrome .


Bevacizumab prolongs progression-free survival ( PFS ) in patients with metastatic colorectal cancer .


We analysed the protein expression levels of vascular endothelial growth factor ( VEGF ) ligands and receptors to determine their prognostic and predictive effects .


We graded expression of VEGF-A , VEGF-B , VEGF-C , VEGF-D , VEGF-R@ , and VEGF-R@ to assess whether overexpression predicted bevacizumab resistance in samples from @ of @ patients randomised to capecitabine ( C ) , capecitabine and bevacizumab ( CB ) , or CB and mitomycin ( CBM ) in the MAX trial and extended the analysis to the CAIRO-@ population .


Patients with low expression of VEGF-D ( @ , @ ) benefited from bevacizumab treatment ( PFS hazard ratio ( HR ) ( C vs CBCBM ) , @ ; @ % CI , @ ; overall survival ( OS ) HR , @ ; @ % CI , @ ) .


Patients with higher VEGF-D expression received less benefit ( VEGF-D @ PFS HR , @ ; @ % CI , @ ; OS HR , @ ; @ % CI , @ ; VEGF-D @ PFS HR , @ ; @ % CI , @ ; OS HR , @ ; @ % CI , @ ) ( P interaction o@ @ ) .


In CAIRO-@ , there was no difference in PFS or OS according to VEGF-D expression .


The predictive value of VEGF-D expression for bevacizumab may depend on the chemotherapy backbone used .


Further evaluation is required before clinical utilisation .


Abnormalities in cardiac structure and function in heart failure with preserved ejection fraction may help identify patients at particularly high risk for cardiovascular morbidity and mortality .


Cardiac structure and function were assessed by echocardiography in a blinded core laboratory at baseline in @ patients with heart failure with preserved ejection fraction ( left ventricular ejection fraction @ % ) enrolled in the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist ( TOPCAT ) trial and related to the primary composite outcome of cardiovascular death , heart failure hospitalization , or aborted cardiac arrest , and its components .


At a median follow-up of @ years , @ patients experienced the primary outcome .


Left ventricular hypertrophy ( adjusted hazard ratio , @ ; @ % confidence interval , @-@ @ ) , elevated left ventricular filling pressure ( E/E ' ; adjusted hazard ratio @ per @ integer increase ; @ % confidence interval , @-@ @ ) , and higher pulmonary artery pressure assessed by the tricuspid regurgitation velocity ( hazard ratio , @ per @ m/s increase ; @ % confidence interval , @-@ @ ) were associated with the composite outcome and heart failure hospitalization alone after adjusting for clinical and laboratory variables .


The risk of adverse outcome associated with left ventricular hypertrophy was additive to the risk associated with elevated E/E ' .


Among heart failure with preserved ejection fraction patients enrolled in TOPCAT , left ventricular hypertrophy , higher left ventricular filling pressure , and higher pulmonary artery pressure were predictive of heart failure hospitalization , cardiovascular death , or aborted cardiac arrest independent of clinical and laboratory predictors .


These features , both alone and in combination , identify heart failure with preserved ejection fraction patients at particularly high risk for cardiovascular morbidity and mortality .


The clinical benefits of bioimpedance spectroscopy ( BIS ) - guided fluid management in patients on hemodialysis have been widely demonstrated .


However , no previous reports have evaluated the effect of regular and serial BIS-guided fluid management on the residual renal function ( RRF ) in patients on peritoneal dialysis ( PD ) .


Therefore , we will evaluate the clinical efficacy of BIS-guided fluid management for preserving RRF and protecting cardiovascular events in patients on PD .


This is a multicenter , prospective , randomized controlled trial .


A total of @ participants on PD will be enrolled and randomly assigned to receive either BIS-guided fluid management or fluid management based only on the clinical information for @ year .


The primary outcome is the change in the glomerular filtration rate ( GFR ) between months @ and @ after starting treatment .


The secondary outcomes will include GFR at month @ , time to the anuric state ( urine volume < @ ml/day ) , and fatal and nonfatal cardiovascular events during treatment .


This is the first clinical trial to investigate the effect of BIS-guided fluid management on RRF and for protecting against cardiovascular events in patients on PD .


This study was performed to compare the mucosal findings after esophagogastroduodenoscopy in two groups before and after the use of alendronate only and following administration of the enteric-coated alendronate ( @ mg ) and calcitriol ( @ g ) combined drug ( Maxmarvil , Yuyu Co. ) .


The study population consisted of @ postmenopausal healthy female volunteers , aged @ to @ years ( mean age , @ @ ) without gastrointestinal symptoms and with normal baseline endoscopic findings .


Esophagogastroduodenoscopy was performed at baseline and was repeated @ weeks later after daily intake of Maxmarvil ( n = @ subjects ) or alendronate only ( n = @ subjects ) .


Mucosal injury scores were reported by an endoscopist after @ weeks of treatment with each medication schedule .


Esophageal mucosal injuries developed in two of @ subjects in the alendronate only group and @ of @ in the Maxmarvil group .


Gastric mucosal injuries developed in eight subjects in the alendronate group and four subjects in the Maxmarvil group ; this difference was statistically significant .


The mucosal damage scores for the alendronate group ( total score @ ) were significantly higher than those for the Maxmarvil group ( total score @ ) in the esophagus and stomach .


Therefore , this study suggested that enteric-coated Maxmarvil is less harmful to gastrointestinal mucosa than alendronate , and may improve the tolerability of osteoporosis medication in clinical practice .


Although antidepressant drugs are used as first-line intervention to treat patients with generalized anxiety disorder ( GAD ) , only one-third of patients respond positively to treatment .


In our study , we investigated whether functional genetic polymorphisms in the dopamine active transporter @ ( DAT@ ) and dopamine receptor D@ ( DRD@ ) may play a role in antidepressant treatment response in GAD .


We examined @ patients diagnosed with GAD who received venlafaxine Extended-Release ( XR ) treatment as part of an @-month relapse-prevention study to determine whether variation in these genes had an effect on treatment response after @months of open-label treatment .


Genotypes were obtained for rs@ ( DRD@ ) , rs@ ( DRD@ ) , rs@ ( DAT@ ) , and a variable number tandem repeat in the @ ' untranslated region of the DAT@ gene using standard methods .


Results show that none of the tested variants were associated with treatment response to venlafaxine XR in GAD .


Genotype and allele frequencies did not differ statistically significantly between responders and non-responders using either the Hamilton Anxiety or Clinical Global Impressions of Improvement Scale at @months .


Although we detected no association in our sample , future studies using larger samples and more comprehensive gene coverage are needed to evaluate potential effects of dopaminergic variants on antidepressant treatment response in anxiety disorders .


In non-small-cell lung cancer , an exon @ deletion and an L@R point mutation in the epidermal growth factor receptor ( EGFR ) are predictors of a response to EGFR-tyrosine kinase inhibitors .


However , it is uncertain whether other uncommon EGFR mutations are associated with sensitivity to EGFR-tyrosine kinase inhibitors .


A post-hoc analysis to assess prognostic factors was performed with the use of patients with EGFR mutations ( exon @ deletion , L@R , G@X , and L@Q ) who were treated with gefitinib in the NEJ@ study , which compared gefitinib with carboplatin-paclitaxel as the first-line therapy .


In the NEJ@ study , @ patients with EGFR mutations received gefitinib at any treatment line .


The Cox proportional hazards model indicated that performance status , response to chemotherapy , response to gefitinib , and mutation types were significant prognostic factors .


Overall survival ( OS ) was significantly shorter among patients with uncommon EGFR mutations ( G@X or L@Q ) compared with OS of those with common EGFR mutations ( @ versus @ months ; p = @ ) .


In the gefitinib group ( n = @ ) , patients with uncommon EGFR mutations had a significantly shorter OS ( @ versus @ months ; p < @ ) .


By contrast , OS was similar between patients with uncommon mutations and those with common mutations in the carboplatin-paclitaxel group ( n = @ ; @ versus @ months ; p = @ ) .


The post-hoc analyses clearly demonstrated shorter survival for gefitinib-treated patients with uncommon EGFR mutations compared with the survival of those with common mutations and suggest that the first-line chemotherapy may be relatively effective for non-small-cell lung cancer with uncommon EGFR mutations .


To compare refractive changes after corneal crosslinking with and without mechanical compression of the cornea .


In a prospective , open , randomized case-control study conducted at the Department of Ophthalmology , Ume University Hospital , Sweden , sixty eyes of @ patients with progressive keratoconus aged @-@ years planned for corneal crosslinking and corresponding age - and sex-matched control subjects were included .


The patients were randomized to conventional corneal crosslinking ( CXL ; n = @ ) or corneal crosslinking with mechanical compression using a flat rigid contact lens sutured to the cornea during treatment ( CRXL ; n = @ ) .


Subjective refraction and ETDRS best spectacle-corrected visual acuity ( BSCVA ) , axial length measurement , keratometry and pachymetry were performed before and @ and @ months after treatment .


The keratoconus patients had poorer BSCVA , higher refractive astigmatism and higher keratometry readings than the control subjects at baseline ( p < @ ) .


In the CXL group , BSCVA increased from @ @ to @ @ logMar ( p = @ ) , and the spherical equivalent improved from -@ @ D to -@ @ D ( p = @ ) .


Maximum keratometry readings decreased after CXL from @ @ D to @ @ D ( p = @ ) , and the axial length decreased in the CXL group , likely due to post-treatment corneal thinning ( p = @ ) .


In the CRXL group , all the above variables were unaltered ( p > @ ) .


At @ months , the refractive results from CRXL did not surpass those of conventional CXL treatment .


Rather , some variables indicated a slightly inferior effect .


Possibly , stronger crosslinking would be necessary to stabilize the cornea in the flattened configuration achieved by the rigid contact lens .


Although coexisting obstructive sleep apnea ( OSA ) and Cheyne-Stokes respiration ( CSR ) occur frequently in patients with heart diseases , optimal treatment remains unclear .


Positive airway pressure ( PAP ) effectively treats OSA and adaptive servo-ventilation ( ASV ) has been shown to improve CSR .


We compared a new treatment algorithm combining automatic continuous positive airway pressure ( APAP ) and ASV ( anticyclic modulated ventilation , ACMV ) versus continuous positive airway pressure ( CPAP ) .


Thirty-nine patients ( @ male , four female ; aged @ years ; body mass index , @ kg/m@ ) with underlying heart disease and coexisting OSA and CSR were enrolled .


After diagnostic polysomnography ( PSG ) and CPAP titration , patients were randomized either to CPAP or to ACMV for four weeks of treatment in a crossover design .


Total apnea-hypopnea index ( AHI ) was @ / h at baseline , @ / h with CPAP ( P < @ vs baseline ) , and @ / h with ACMV ( P < @ vs. baseline and vs. CPAP ) .


Obstructive AHI was @ / h at baseline , @ / h with CPAP ( P < @ vs. baseline ) , and @ / h with ACMV ( P < @ vs. baseline and vs. CPAP ) .


Central AHI was @ / h at baseline , @ / h with CPAP ( P < @ vs baseline ) and @ / h with ACMV ( P < @ vs. baseline and vs. CPAP ) .


Ejection fraction was increased significantly ( from @ to @ % ) only with ACMV .


Subjective sleepiness significantly improved only with CPAP whereas objective sleep quality and treatment adherence were not different between both treatment modalities .


ACMV is an effective treatment option in patients with coexisting OSA and CSR .


It is superior to CPAP in reducing total AHI as well as obstructive and central AHI .


HER@ and TOP@A gene status are assessed for diagnostic and research purposes in breast cancer with fluorescence in situ hybridization ( FISH ) .


However , FISH probes do not target only the annotated gene , while chromosome @ ( chr@ ) is among the most unstable chromosomes in breast cancer .


Here we asked whether the status of specifically targeted genes on chr@ might help in refining prognosis of early high-risk breast cancer patients .


Copy numbers ( CN ) for @ genes on chr@ , @ of which were within and @ outside the core HER@ amplicon ( HER@ - and non-HER@-genes , respectively ) were assessed with qPCR in @ paraffin-embedded tumor tissue samples from breast cancer patients treated with adjuvant chemotherapy in the frame of two randomized phase III trials .


HER@-genes CN strongly correlated to each other ( Spearman 's rho > @ ) and were concordant with FISH HER@ status ( Kappa @ for ERBB@ CN ) .


TOP@A CN were not concordant with TOP@A FISH status ( Kappa @ ) .


CN hierarchical clustering revealed distinct patterns of gains , losses and complex alterations in HER@ - and non-HER@-genes associated with IHC@ breast cancer subtypes .


Upon multivariate analysis , non-HER@-gene gains independently predicted for shorter disease-free survival ( DFS ) and overall survival ( OS ) in patients with triple-negative cancer , as compared to luminal and HER@-positive tumors ( interaction p = @ for DFS and p = @ for OS ) .


Similarly , non-HER@-gene gains were associated with worse prognosis in patients who had undergone breast-conserving surgery as compared to modified radical mastectomy ( p = @ for both DFS and OS ) .


Non-HER@-gene losses were unfavorable prognosticators in patients with @-@ metastatic nodes , as compared to those with @ or more nodes ( p = @ for DFS and p = @ for OS ) .


TOP@A FISH and qPCR may not identify the same pathology on chr@q .


Non-HER@ chr@ CN patterns may further predict outcome in breast cancer patients with known favorable and unfavorable prognosis .


Heart failure ( HF ) and chronic obstructive pulmonary disease ( COPD ) frequently coexist , with undefined prognostic and therapeutic implications .


We investigated clinical profile and outcomes of patients with chronic HF and COPD , notably the efficacy and safety of ivabradine , a heart rate-reducing agent .


@ ambulatory patients , in sinus rhythm , heart rate @ bpm and stable systolic HF were randomised to placebo or ivabradine ( @ to @ mg bid ) .


Multivariate Cox model analyses were performed to compare the COPD ( n = @ ) and non-COPD subgroups , and the ivabradine and placebo treatment effects .


COPD patients were older and had a poorer risk profile .


Beta-blockers were prescribed to @ % of COPD patients and @ % of non-COPD patients .


The primary endpoint ( PEP ) and its component , hospitalisation for worsening HF , were more frequent in COPD patients ( HRs f , @ -LSB- p = @ -RSB- ; and @ -LSB- p < @ -RSB- ) respectively , but relative risk was reduced similarly by ivabradine in both COPD ( @ % , and @ % ) and non-COPD ( @ % and @ % ) patients ( p interaction = @ , and @ , respectively ) .


Similar effect was noted also for cardiovascular death .


Adverse events were more common in COPD patients , but similar in treatment subgroups .


Bradycardia occurred more frequently in ivabradine subgroups , with similar incidence in patients with or without COPD .


The association of COPD and HF results in a worse prognosis , and COPD represents a barrier to optimisation of beta-blocker therapy .


Ivabradine is similarly effective and safe in chronic HF patients with or without COPD , and can be safely combined with beta-blockers in COPD .


Although several eating disorder prevention programs reduce eating disorder risk factors and symptoms for female high school and college students , few efficacious prevention programs exist for female middle school students , despite the fact that body image and eating disturbances often emerge then .


Two pilot trials evaluated a new dissonance-based eating disorder prevention program for middle school girls with body image concerns .


Female middle school students with body dissatisfaction from two sites -LSB- Study @ : N = @ , M age = @ , standard deviation ( SD ) = @ ; Study @ : N = @ , M age = @ , SD = @ -RSB- were randomized to a dissonance intervention ( MS Body Project ) or educational brochure control ; Study @ included a @-month follow-up .


Intervention participants showed significant post-test reductions in only one of the six variables with both Studies @ and @ ( i.e. , pressure to be thin and negative affect , respectively ) , though post-test effect sizes suggested medium reductions in eating disorder risk factors and symptoms ( Study @ : M d = @ ; Study @ : M d = @ ) ; reductions at @-month follow-up in Study @ were not evident ( M d = @ ) .


Results suggest that this new middle school version of the Body Project is producing medium magnitude reductions in eating disorder risk factors at post-test but that effects are showing limited persistence .


Continued refinement and evaluation of this intervention appears warranted to develop more effective prevention programs for this age group .


The aim of this study is to evaluate the effect of oral glutamine ( GL ) supplementation on gut permeability and endotoxemia ( surrogate end point ) in patients with severe acute pancreatitis .


In a randomized controlled trial , patients were randomized to be given placebo or GL for @ days .


The primary outcome measures include the effect on gut permeability ( assessed by lactulose/mannitol excretion in urine and endotoxemia assessed by endotoxin core antibodies type IgG and IgM ( EndoCab IgG and IgM ) .


The secondary outcome measures include infectious complications , mortality , total hospital/intensive care unit stay , C-reactive protein , and prealbumin levels .


Patients were assigned to GL ( n = @ ) and placebo ( n = @ ) groups .


There was no change in gut permeability after the intervention .


However , the EndoCab IgM levels increased significantly ( @ -LSB- @ , @ -RSB- to @ -LSB- @ , @ -RSB- GMU/mL ; P = @ ) and the C-reactive protein levels decreased significantly ( @ -LSB- @ , @ -RSB- to @ -LSB- @ , @ -RSB- ng/mL ; P = @ ) in the GL group .


No difference was observed in infectious complication , prealbumin value , hospital/intensive care unit stay , and mortality in both groups .


No significant trend was identified for an effect of GL on gut permeability .


Decreased inflammation and endotoxemia did not translate into reduced infectious complications in severe acute pancreatitis .


However , the study was underpowered to detect the aforementioned difference ( trial registration : CTRI/@/@ ) .


Tapentadol is an analgesic agent for treatment of acute and chronic pain that activates the - opioid receptor combined with inhibition of neuronal norepinephrine reuptake .


Both mechanisms are implicated in activation of descending inhibitory pain pathways .


In this study , we investigated the influence of tapentadol on conditioned pain modulation ( CPM , an experimental measure of endogenous pain inhibition that gates incoming pain signals as a consequence of a preceding tonic painful stimulus ) and offset analgesia ( OA , a test in which a disproportionally large amount of analgesia becomes apparent upon a slight decrease in noxious heat stimulation ) .


Twenty-four patients with diabetic polyneuropathy ( DPN ) were randomized to receive daily treatment with tapentadol sustained-release ( SR ) -LSB- average daily dose @ ( @ ) mg -RSB- or placebo for @ weeks .


CPM and OA were measured before and on the last day of treatment .


Before treatment , none of the patients had significant CPM or OA responses .


At week @ of treatment , CPM was significantly activated by tapentadol SR and coincided with significant analgesic responses .


CPM increased from @ ( @ ) % ( baseline ) to @ ( @ ) % ( placebo ) and @ ( @ ) % ( tapentadol SR , P < @ vs placebo ) ; relief of DPN pain was also greater in patients treated with tapentadol than placebo ( P = @ ) .


Neither placebo nor tapentadol SR treatment had an effect on the magnitude of the OA responses ( P = @ ) .


Tapentadol 's analgesic effect in chronic pain patients with DPN is dependent on activation of descending inhibitory pain pathways as observed by CPM responses .


To characterize the safety , tolerability , pharmacokinetics ( PK ) and dose proportionality of mipomersen after single subcutaneous ( SC ) administration to Japanese healthy subjects ; and to compare the PK profiles of Japanese and Western subjects .


@ healthy first-generation Japanese male subjects were enrolled into one of three treatment cohorts ( @ , @ and @ mg SC ) in a dose-escalation design .


Within each cohort , subjects were randomized in a @ : @ ratio to receive mipomersen or placebo .


Mipomersen was absorbed rapidly after SC administration ; median tmax varied between @ and @ hours .


After reaching peak levels , plasma concentrations of mipomersen decayed multiphasically with an initial distribution t@/@ in several hours and a terminal t@/@ of @ - @ hours .


Mean Cmax increased in a dose-linear manner while all mean AUC from time @ to different cut points increased slightly more than dose proportionally .


Although mean terminal t@/@ varied in the dose range tested , it did not show dose-dependence .


The PK profiles of mipomersen in Japanese subjects are similar to those observed in Western subjects .


A single SC dose of @ mg , @ mg and @ mg mipomersen was well tolerated by male Japanese subjects .


Single SC doses of @ - @ mg were safe and well tolerated when administered to Japanese subjects .


Comparison of PK between Japanese and Western subjects does not support any need for dose adjustment in Japanese population in future clinical development .


The granisetron transdermal system ( GTS ) showed non-inferior efficacy to oral granisetron to control chemotherapy-induced nausea and vomiting ( CINV ) during multiday chemotherapy .


We compared the efficacy and safety of GTS with that of intravenous and oral granisetron in Korean patients receiving moderately emetogenic chemotherapy ( MEC ) .


A total of @ patients were randomized into GTS ( n = @ , one patch on days @-@ ) or control group ( n = @ , intravenous on day @ and oral on days @-@ ) .


The primary endpoint was the percentage of patients achieving complete response ( CR ) from chemotherapy initiation until @ h after the final administration .


Out of @ patients ( @ in GTS and @ in control group ) included in the per protocol analysis , @ % had gastrointestinal cancer and @ % received @-day chemotherapy .


The GTS showed non-inferior efficacy achieving CR in @ % of the patients ; @ % of the patients in the control group achieved CR ( @ % confidence interval -@ to @ % ) .


The CR rate did not change after subgroup analyses by sex , age , and chemotherapy naivety and analysis per day and overall days of treatment .


The GTS group showed sustained CR from day @ to day @ .


Patients ' satisfaction , assessed using Functional Living Index-Emesis ( FLI-E ) , showed no difference .


Both treatments were well tolerated and safe .


The GTS showed non-inferior efficacy to intravenous and oral granisetron .


The safety , tolerability , and FLI-E scores of the GTS were comparable to those of control group .


The GTS offers a convenient alternative option for relieving CINV in patients receiving MEC .


The Creighton Model FertilityCare System ( CrMS ) teaches women to identify days when intercourse is likely to result in pregnancy .


We sought to assess the impact of the CrMS on time to pregnancy ( TTP ) , via per-cycle pregnancy rates ( fecundability ) .


We conducted a parallel randomised trial at the University of Utah School of Medicine , @-@ .


Women ages @-@ years , in a relationship of proven fertility , who desired to conceive , were block-randomised and stratified for age , with allocation concealment by opaque sequentially numbered sealed envelopes .


The control group received the advice to have intercourse @-@ times per week , and the intervention group received CrMS instruction .


All women were asked to begin trying to conceive starting the second cycle in the study and were followed actively up to seven cycles , without blinding of research personnel .


We calculated descriptive statistics and fecundability , and estimated Cox models for TTP .


( Clinicaltrials.gov NCT@ ) .


There were @ women randomised : @ to the control group ( all analysed ) and @ to the CrMS group ( @ analysed ) .


The adjusted hazard ratio for the influence of CrMS on TTP was @ -LSB- @ % confidence interval ( CI ) : @ , @ -RSB- .


Fecundability in cycles with intent to conceive was @ % in controls and @ % with CrMS ( P = @ ) .


By the first cycle , fecundability was @ % in controls , and @ % with CrMS ( P = @ ) .


No adverse events were reported .


We found no significant impact of CrMS on TTP or fecundability , but fewer of the women receiving CrMS conceived by the first cycle .


Migraine is a highly disabling disease affecting a significant proportion of the Australian population .


The methylenetetrahydrofolate reductase ( MTHFR ) C@T variant has been associated with increased levels of homocysteine and risk of migraine with aura ( MA ) .


Folic acid ( FA ) , vitamin B@ , and B@ supplementation has been previously shown to reduce increased levels of homocysteine and decrease migraine symptoms .


However , the influence of dietary folate intake on migraine has been unclear .


The aim of the current study was to analyze the association of dietary folate intake in the form of dietary folate equivalent , FA , and total food folate ( TFF ) on migraine frequency , severity , and disability .


A cohort of @ adult females of Caucasian descent with MA was genotyped for the MTHFR C@T variant using restriction enzyme digestion .


Dietary folate information was collected from all participants and analyzed using the `` FoodWorks '' @ package .


Folate consumption was compared with migraine frequency , severity , and disability using linear regression .


A significant inverse relation was observed between dietary folate equivalent ( R ( @ ) = @ , B = -@ , P = @ , @ % confidence interval -LSB- CI -RSB- -LSB- -@ , -@ -RSB- ) and FA ( R ( @ ) = @ , B = -@ , P = @ , @ % CI -LSB- -@ , -@ -RSB- ) consumption and migraine frequency .


It was also observed that in individuals with the CC genotype for the MTHFR C@T variant , migraine frequency was significantly linked to FA consumption ( R ( @ ) = @ , B = -@ , P = @ , @ % CI -LSB- -@ , -@ -RSB- ) .


The results from this study indicate that folate intake in the form of FA may influence migraine frequency in female MA sufferers .


Electronic monitoring is recommended for accurate measurement of medication adherence but a possible limitation is that it may influence adherence .


To test the reactive effect of electronic monitoring in a randomized controlled trial .


A total of @ adults with type @ diabetes and HbA@c @mmol/mol were randomized to receiving their main oral glucose lowering medication in electronic containers or standard packaging .


The primary outcomes were self-reported adherence measured with the MARS ( Medication Adherence Report Scale ; range @-@ ) and HbA@c at @weeks .


Non-significantly higher adherence and lower HbA@c were observed in the electronic container group ( differences in means , adjusting for baseline value : MARS , @ -LSB- @ % CI -@ to @ , p = @ -RSB- ; HbA@c ( mmol/mol ) , -@ -LSB- -@ to @ , p = @ -RSB- ) .


Electronic containers may lead to a small increase in adherence but this potential limitation is outweighed by their advantages .


Our findings support electronic monitoring as the method of choice in research on medication adherence .


( Trial registration Current Controlled Trials ISRCT N@ ) .


High levels of fibroblast growth factor @ are associated with accelerated progression of CKD .


Whether high fibroblast growth factor @ levels also predict incident CKD is uncertain .


A prospective case-cohort study was conducted within the Action to Control Cardiovascular Risk in Diabetes Trial .


The analytic sample consisted of a random subcohort of @ patients with type @ diabetes without prevalent CKD at baseline , @ of whom developed incident CKD during follow-up , and @ additional patients with incident CKD outside the random subcohort .


The association between serum intact fibroblast growth factor @ and incident CKD , defined as the new onset of eGFR < @ ml/min per @ m ( @ ) that represented a @ % decrease from baseline in an individual with eGFR@ ml/min per @ m ( @ ) and no microalbuminuria ( < @ mg/g creatinine ) at baseline , was tested .


The mean baseline eGFR in the random subcohort was @ ml/min per @ m ( @ ) .


During a median follow-up of @ years , there was a total of @ patients with incident CKD .


The median baseline fibroblast growth factor @ level was modestly higher among patients with incident CKD versus controls ( @ , interquartile range = @-@ @ versus @ , interquartile range = @-@ @ pg/ml ; P < @ ) .


Higher baseline fibroblast growth factor @ levels were associated with higher risk of incident CKD in unadjusted and demographics-adjusted models , but the effect was attenuated after additional adjustment for clinical risk factors and baseline eGFR ( hazard ratio per SD of natural log fibroblast growth factor @ , @ ; @ % confidence interval , @ to @ ) , which was the strongest predictor of incident CKD .


Consistent with the results of primary analyses , baseline fibroblast growth factor @ was not associated with eGFR slope .


Higher fibroblast growth factor @ levels are not independently associated with higher risk of incident CKD in patients with type @ diabetes .


Many commencing junior doctors worldwide feel ill-prepared to deal with their new responsibilities , particularly prescribing .


Simulation has been widely utilised in medical education , but the use of extended multi-method simulation to emulate the junior doctor experience has rarely been reported .


A randomised controlled trial compared students who underwent two , week-long , extended simulations , several months apart ( Intervention ) , with students who attended related workshops and seminars alone ( Control ) , for a range of outcome measures .


Eighty-four third year students in a graduate-entry medical program were randomised , and @ completed the study .


At the end of the first week , Intervention students scored a mean of @ % on a prescribing test , compared with @ % for Control students ( P = @ ) and Intervention teams initiated cardiac compressions a mean of @ seconds into a resuscitation test scenario , compared with @ seconds for Control teams ( P < @ ) .


At the beginning of the second week , an average of nine months later , a significant difference was maintained in relation to the prescribing test only ( @ % vs @ % , P < @ ) .


At the end of the second week , significant Intervention vs Control differences were seen on knowledge and reasoning tests , a further prescribing test ( @ % vs @ % -LSB- P < @ -RSB- ) and a paediatric resuscitation scenario test ( @ seconds to initiation of fluid resuscitation vs @ seconds -LSB- P = @ -RSB- ) .


The study demonstrated long-term retention of improved prescribing skills , and an immediate effect on knowledge acquisition , reasoning and resuscitation skills , from contextualising learning activities through extended multi-method simulation .


Identify predictors of non-compliance with first round screening exams in the Prostate , Lung , Colorectal and Ovarian ( PLCO ) Cancer Screening Trial .


The PLCO was conducted from @ to @ at @ US institutions .


A total of @,@ healthy men and women ages @-@ years were randomized .


Intervention arm participants were invited to receive gender-appropriate screening exams for prostate , lung , colorectal and ovarian cancer .


Using intervention-arm data ( @,@ participants ) , non-compliance percentages for @ covariates were calculated , as were unadjusted and adjusted odds ratios ( ORs ) , and @ % confidence intervals .


Covariates included demographic factors as well as factors specific to PLCO ( e.g. , method of consent , distance from screening center ) .


The rate of non-compliance was @ % overall but varied by screening center .


Significant associations were observed for most covariates but indicated modest increases or decreases in odds .


An exception was the use of a two-step consent process ( consented intervention arm participants for exams after randomization ) relative to a one-step process ( consented all participants prior to randomization ) ( OR : @ , @ % CI : @-@ @ ) .


Non-compliance percentages increased with further distance from screening centers , but ORs were not significantly different from @ .


Many factors modestly influenced compliance .


Consent process was the strongest predictor of compliance .


Regular exercise is an effective intervention to decrease blood pressure ( BP ) in hypertension , but no data are available concerning the effects of heated water-based exercise ( HEx ) .


This study examines the effects of HEx on BP in resistant hypertensive patients .


This is a parallel , randomized controlled trial .


@ nonconsecutive sedentary patients with resistant hypertension from a hypertension outpatient clinic in a university hospital were screened ; @ patients fulfilled the study requirements .


The training was performed for @-minute sessions in a heated pool ( @C ) , three times a week for @ weeks .


The HEx protocol consisted of callisthenic exercises and walking inside the pool .


The control group was asked to maintain habitual activities .


The main outcome measure was change in mean @-hour ambulatory BP ( ABPM ) .


@ patients ( HEx n = @ ; control n = @ ) were randomized ; none were lost to follow-up .


Office BPs decreased significantly after heated water exercise ( @/@ mmHg ) .


HEx decreased @-hour systolic ( from @ to @ mmHg , p = @ ) and diastolic BPs ( from @ to @ mmHg , p = @ ) ; daytime systolic ( from @ to @ mmHg , p < @ ) and diastolic BPs ( from @ to @ mmHg , p = @ ) ; and nighttime systolic ( from @ to @ mmHg , p = @ ) and diastolic BPs ( from @ to @ mmHg , p < @ ) .


The control group after @ weeks significantly increased in @-hour systolic and diastolic BPs , and daytime and nighttime diastolic BPs .


HEx reduced office BPs and @-hour ABPM levels in resistant hypertensive patients .


These effects suggest that HEx may be a potential new therapeutic approach in these patients .


Botulinum neurotoxin type A trials in aesthetic indications have used differing efficacy parameters and responder definitions .


To analyze the treatment efficacy and duration of incobotulinumtoxinA for glabellar frown lines using pooled data from @ large , Phase @ , placebo-controlled trials , and end points similar to those used in previous botulinum neurotoxin type A studies .


IncobotulinumtoxinA and placebo groups comprised @ and @ subjects , respectively .


The efficacy of a single @-U treatment of incobotulinumtoxinA or placebo was evaluated by investigator-assessed and subject-assessed responder rates ( @-point improvement from baseline ) , mean score , and mean change from the baseline glabellar frown line severity score .


At all follow-up visits , responder rates and mean change from the baseline score ( investigator-assessed and subject-assessed ) were significantly greater for incobotulinumtoxinA versus placebo ( p < @ ) .


The maximum investigator-assessed responder rate ( @ % ) was achieved at Day @ after treatment , when the mean improvement on the @-point facial wrinkle scale peaked at @ .


Treatment effect declined over time but the investigator-assessed responder rate was @ % at the end of the study .


Superiority of incobotulinumtoxinA over placebo for treating glabellar frown lines was confirmed .


IncobotulinumtoxinA achieved a maximum responder rate of @ % and a long duration of treatment effect : @ % of subjects showed efficacy at @ days .


To investigate whether standardised cigarette packaging increases the time spent looking at health warnings , regardless of the format of those warnings .


A factorial ( two pack styles x three warning types ) within-subject experiment , with participants randomised to different orders of conditions , completed at a university in London , UK .


Mock-ups of cigarette packets were presented to participants with their branded portion in either standardised ( plain ) or manufacturer-designed ( branded ) format .


Health warnings were present on all packets , representing all three types currently in use in the UK : black & white text , colour text , or colour images with accompanying text .


Gaze position was recorded using a specialised eye tracker , providing the main outcome measure , which was the mean proportion of a five-second viewing period spent gazing at the warning-label region of the packet .


An opportunity sample of @ ( six male , mean age = @ ) young adults met the following inclusion criteria : @ ) not currently a smoker ; @ ) < @ lifetime cigarettes smoked ; @ ) gaze position successfully tracked for > @ % viewing time .


These participants spent a greater proportion of the available time gazing at the warning-label region when the branded section of the pack was standardised ( following current Australian guidelines ) rather than containing the manufacturer 's preferred design ( mean difference in proportions = @ , @ % confidence interval @ to @ , p < @ ) .


There was no evidence that this effect varied based on the type of warning label ( black & white text vs. colour text vs. colour image & text ; interaction p = @ ) .


During incidental viewing of cigarette packets , young adult never-smokers are likely to spend more time looking at health warnings if manufacturers are compelled to use standardised packaging , regardless of the warning design .


To provide the @-week prevalence estimates of mental disorders in cancer populations .


We enrolled adult patients with cancer from in - and outpatient care facilities , using a proportional stratified random sample based on the nationwide cancer incidence in Germany .


Patients who scored @ or above on the Patient Health Questionnaire ( PHQ-@ ) were administered to the standardized computer-assisted Composite International Diagnostic Interview for mental disorders adapted for cancer patients ( CIDI-O ) .


A random sample of those with a PHQ-@ score that was less than @ were selected for a CIDI-O .


A total of @,@ patients were identified , which led to @,@ participants ( a @ % response rate ) ; of those , @,@ patients were interviewed .


The @-week total prevalence for any mental disorder was @ % ( @ % CI , @ % to @ % ) ; this included any anxiety disorder ( @ % ; @ % CI , @ % to @ % ) , any adjustment disorder ( @ % ; @ % CI , @ % to @ % ) , any mood disorder ( @ % ; @ % CI , @ % to @ % ) , any somatoform/conversion disorder ( @ % ; @ % CI , @ % to @ % ) , nicotine dependence ( @ % ; @ % CI , @ % to @ % ) , alcohol abuse/dependence ( @ % ; @ % CI , @ % to @ % ) , any mental disorder resulting from general medical condition ( @ % ; @ % CI , @ % to @ % ) , and any eating disorder ( @ % ) .


The highest prevalence for any mental disorder was found in patients with breast cancer ( @ % ; @ % CI , @ % to @ % ) , followed by patients with head and neck cancer ( @ % ; @ % CI , @ % to @ % ) .


The lowest prevalence was found in patients with pancreatic cancer ( @ % ; @ % CI , @ % to @ % ) and stomach/esophagus cancers ( @ % ; @ % CI , @ % to @ % ) .


Our findings provide evidence for the strong need for psycho-oncological interventions .


Birt-Hogg-Dub syndrome ( BHD ) is a rare autosomal dominant disorder characterised by the occurrence of benign , mostly facial , skin tumours called fibrofolliculomas , multiple lung cysts , spontaneous pneumothorax and an increased renal cancer risk .


Current treatments for fibrofolliculomas have high rates of recurrence and carry a risk of complications .


It would be desirable to have a treatment that could prevent fibrofolliculomas from growing .


Animal models of BHD have previously shown deregulation of mammalian target of rapamycin ( mTOR ) .


Topical use of the mTOR inhibitor rapamycin is an effective treatment for the skin tumours ( angiofibromas ) in tuberous sclerosis complex , which is also characterised by mTOR deregulation .


In this study we aimed to determine if topical rapamycin is also an effective treatment for fibrofolliculomas in BHD. .


We performed a double blinded , randomised , facial left-right controlled trial of topical rapamycin @ % versus placebo in @ BHD patients .


Trial duration was @ months .


The primary outcome was cosmetic improvement as measured by doctors and patients .


Changes in fibrofolliculoma number and size were also measured , as was occurrence of side effects .


No change in cosmetic status of fibrofolliculomas was reported in the majority of cases for the rapamycin treated ( @ % by doctors , @ % by patients ) as well as the placebo treated facial sides ( both @ % ) .


No significant differences between rapamycin and placebo treated facial halves were observed ( p = @ for doctors opinion , p = @ for patients opinion ) .


No significant difference in fibrofolliculoma number or change in size of the fibrofolliculomas was seen after @ months .


Side effects occurred more often after rapamycin treatment ( @ % of patients ) than after placebo ( @ % of patients ; p = @ ) .


A burning sensation , erythema , itching and dryness were most frequently reported .


This study provides no evidence that treatment of fibrofolliculomas with topical rapamycin in BHD results in cosmetic improvement .


Accurately estimating the period of time that individuals are exposed to online intervention content is important for understanding program engagement .


This can be calculated from time-stamped data reflecting navigation to and from individual webpages .


Prolonged periods of inactivity are commonly handled with a time-out feature and assigned a prespecified exposure duration .


Unfortunately , this practice can lead to biased results describing program exposure .


The aim of the study was to describe how multiple imputations can be used to better account for the time spent viewing webpages that result in a prolonged period of inactivity or a time-out .


To illustrate this method , we present data on time-outs collected from the Q ( @ ) randomized smoking cessation trial .


For this analysis , we evaluate the effects on intervention exposure of receiving content written in a prescriptive versus motivational tone .


Using multiple imputations , we created five complete datasets in which the time spent viewing webpages that resulted in a time-out were replaced with values estimated with imputation models .


We calculated standard errors using Rubin 's formulas to account for the variability due to the imputations .


We also illustrate how current methods of accounting for time-outs ( excluding timed-out page views or assigning an arbitrary viewing time ) can influence conclusions about participant engagement .


A total of @ % ( @/@ ) of participants accessed the online intervention in the Q ( @ ) trial .


Of the @ unique page views , @ ( @ % , @/@ ) resulted in a time-out .


The median time spent viewing webpages that did not result in a time-out was @ minutes .


Assuming participants did not spend any time viewing a webpage that resulted in a time-out , no difference between the two message tones was observed ( ratio of mean time online : @ , @ % CI @-@ @ ) .


Assigning @ minutes of viewing time to all page views that resulted in a time-out concludes that participants who received content in a motivational tone spent less time viewing content ( ratio of mean time online : @ , @ % CI @-@ @ ) than those participants who received content in a prescriptive tone .


Using multiple imputations to account for time-outs concludes that there is no difference in participant engagement between the two message tones ( ratio of mean time online : @ ; @ % CI @-@ @ ) .


The analytic technique chosen can significantly affect conclusions about online intervention engagement .


We propose a standardized methodology in which time spent viewing webpages that result in a time-out is treated as missing information and corrected with multiple imputations .


To evaluate the lung function and clinical outcome in severe chronic obstructive pulmonary disease in patients undergoing off-pump coronary artery bypass grafting with left internal thoracic artery graft , comparing the pleural drain insertion in the intercostal versus subxyphoid region .


A randomized controlled trial .


Chronic obstructive pulmonary disease patients were randomized into two groups according pleural drain site : II group ( n = @ ) - pleural drain in intercostal space ; SI group ( n = @ ) - pleural drain in the subxyphoid region .


Spirometry values ( Forced Vital Capacity - and Forced expiratory volume in @ second ) were obtained on preoperative and @ , @ and @ postoperative days .


Chest x-ray from preoperative until postoperative day @ ( POD@ ) was performed for monitoring respiratory events , such as atelectasis and pleural effusion .


Pulmonary shunt fraction and pain score was evaluate preoperatively and on postoperative day @ .


In both groups there was a significant decrease of the spirometry values ( Forced Vital Capacity and Forced expiratory volume in @ second ) until POD@ ( P < @ ) .


However , when compared , SI group presented less decrease in these parameters ( P < @ ) .


Pulmonary shunt fraction was significantly lower in SI group ( P < @ ) .


Respiratory events , pain score , orotracheal intubation time and postoperative length of hospital stay were lower in the SI group ( P < @ ) .


Subxyphoid pleural drainage in severe Chronic obstructive pulmonary disease patients determined better preservation and recovery of pulmonary capacity and volumes with lower pulmonary shunt fraction and better clinical outcomes on early postoperative off-pump coronary artery bypass grafting .


Little is known about the effects of natural mineral water on constipation in adults .


We assessed the effect of a magnesium sulfate-rich natural mineral water ( Hpar ; Nestl Waters , Issy-les-Moulineaux , France ) on gastrointestinal transit in constipated women .


We performed a randomized , double-blind , placebo-controlled trial to evaluate the efficacy and safety of Hpar in outpatients with functional constipation ( based on the Rome III criteria ) .


The study included @ female patients , age @ to @ years , identified by @ general practitioners throughout France .


After a washout period , subjects drank @ L natural low-mineral water daily ( control , n = @ ) , @ L Hpar and @ L natural low-mineral water daily ( Hpar @ group , n = @ ) , or @ L Hpar and @ L natural low-mineral water daily ( Hpar @ group , n = @ ) for @ weeks .


We collected information on the number and types of stools , abdominal pain , rescue medications , adverse events , and volume of water consumed .


We observed no significant effect at week @ .


At week @ , constipation was reduced in @ % of patients in the control group , in @ % in the Hpar @ group ( P = @ vs controls ) , and in @ % in the Hpar @ group ( P = @ vs controls ) .


The Hpar @ group also had a decreased number of hard or lumpy stools ( Bristol scale , P = @ vs baseline ) and a substantial decrease in the use of rescue medication ( P = @ vs controls ) .


Patient responses correlated with magnesium sulfate concentrations .


Safety was very good ; there were no serious adverse events among patients who drank Hpar .


In a controlled trial , daily consumption of @ L Hpar reduced constipation and hard or lumpy stools in a greater percentage of women with functional constipation than natural low-mineral water , as early as the second week of treatment .


To evaluate the efficacy of adding nepafenac @ % ophthalmic suspension to dexamethasone @ % eyedrops in controlling macular swelling and other manifestations of inflammation after uneventful cataract surgery .


Ophthalmology Department , Mlndal Hospital , Gothenburg , and St. Erik Eye Hospital , Stockholm , Sweden .


Randomized double-masked clinical trial .


Patients at low risk for postoperative inflammation were recruited and randomized to the nepafenac group or to the control group .


Postoperative swelling of the macula was assessed with ocular coherence tomography .


Laser flare intensity , corrected distance visual acuity , ocular discomfort , and visual complaints were also recorded .


The analysis of intent-to-treat population comprised @ patients in the nepafenac group and @ patients in the control group .


Compared with the control regimen , add-on nepafenac resulted in statistically significant reductions in the following parameters : change in macular volume at @ weeks and @ weeks ( P < @ ) , proportion of patients with more than @ m of swelling in the central macula at @ weeks ( P < @ ) and @ weeks ( P = @ ) , mean laser flare intensity at @ day ( P = @ ) , pain during the first @ hours postoperatively ( P < @ ) , and ocular discomfort and photophobia during the first @ postoperative weeks ( P = @ and P = @ , respectively ) .


The combination of topical nepafenac and steroid treatment reduced subclinical macular swelling and inflammation as well as subjective complaints , indicating it is an efficient antiinflammatory regimen after cataract surgery .


Cutaneous telangiectases are a characteristic and psychologically distressing feature of SSc .


Our aim was to assess the efficacy of two light-based treatments : pulsed dye laser ( PDL ) and intense pulsed light ( IPL ) .


Nineteen patients with facial or upper limb telangiectases underwent three treatments with PDL and IPL ( randomly assigned to left - and right-sided lesions ) .


Outcome measures were clinical photography ( assessed by two clinicians ) , dermoscopy ( assessed by two observers ) , laser Doppler imaging ( LDI ) and observer and patient opinion , including patient self-assessment psychological questionnaires -LSB- Hospital Anxiety and Depression Scale ( HADS ) , Adapted Satisfaction with Appearance Scale ( ASWAP ) -RSB- .


Comparison between @-week follow-up and baseline photography scores ( from -@ to +@ on a Likert scale , with > @ being improvement ) were a mean score for PDL of @ ( @ % CI @ , @ ) and for IPL @ ( @ , @ ) , with a mean difference between PDL and IPL of -@ ( -@ , -@ ) ( P = @ ) .


Dermoscopy scores also improved with both therapies : PDL @ ( @ , @ ) and IPL @ ( @ , @ ) , again greater with PDL ( P = @ ) .


LDI showed decreases in blood flow at @ weeks , indicating a response to both therapies .


All patients reported benefit from treatment ( more preferred PDL at @ weeks ) .


Psychological questionnaires also indicated improvement after therapy with mean change in ASWAP of -@ ( @ % CI -@ , -@ ) .


No side effects were reported for IPL ; PDL caused transient bruising in most cases .


Both PDL and IPL are effective treatments for SSc-related telangiectases .


Outcome measures indicate that PDL has better outcomes in terms of appearance , although IPL had fewer side effects .


To explore the roles of ribavirin aerosol in the prevention and treatment of hand-foot-mouth disease ( HFMD ) .


For this prospective , multicenter , randomized , double-blind and placebo-controlled trial , a total of @ HFMD outpatients from @ class @A hospitals from July @ to June @ were divided into treatment ( ribavirin aerosol ) and control ( placebo ) groups ( n = @ each ) .


The age range was @ months to @ years .


The proportion of male and female was @ : @ .


Temperature , herpes of mouth and skin rash were observed before and after treatments .


Before treatment and @-@ days after , their specimens of throat swab were collected and the levels of EV@ and CA@ detected with reverse transcription ( RT ) - PCR .


The software SAS @ was used for statistic data analyses .


Before treatment , no significant statistical difference existed in parameters between treatment and control groups ( all P > @ ) .


After treatment , the degree of herpes of mouth and papulovesicle of skin in treatment group was better than that in control group ( @ % ( @/@ ) vs @ % ( @/@ ) , ( @ ) = @ , P < @ ) ; ( @ % ( @/@ ) vs @ % ( @/@ ) , ( @ ) = @ , P < @ ) .


The virus negative conversion rates had significant inter-group difference ( @ % ( @/@ ) vs @ % ( @/@ ) , ( @ ) = @ , P < @ ) .


The temperature , compliance and differences were not significant ( all P > @ ) .


The effective rate of comprehensive efficacy in treatment group was higher than that in control group ( @ % ( @/@ ) vs @ % ( @/@ ) , ( @ ) = @ , P < @ ) .


No obvious adverse drug reaction was observed .


Ribavirin aerosol has multiple advantages of lower dose , quicker onset , higher local concentration , better clinical efficacy and fewer side-effects .


Its therapeutic effect for local lesion is better than that for systemic lesion .


Thus it may shorten the duration of oropharyngeal and skin lesions and lower the number and time of viral release .


Early combination antiretroviral therapy ( cART ) initiation at the time of primary HIV-@ infection could restrict the establishment of HIV reservoirs .


We aimed to assess the effect of a cART regimen intensified with raltegravir and maraviroc , compared with standard triple-drug cART , on HIV-DNA load .


In this randomised , open-label , phase @ trial , we recruited patients from hospitals across France .


Inclusion criteria were primary HIV-@ infection ( an incomplete HIV-@ western blot and detectable plasma HIV-RNA ) , with either symptoms or a CD@ + cell count below @ cells per L. Patients were randomly assigned ( @:@ ) to an intensive , five-drug cART regimen ( raltegravir @ mg and maraviroc @ mg twice daily , and a fixed-dose combination of tenofovir disoproxil fumarate @ g plus emtricitabine @ g , darunavir @ g , and ritonavir @ g once daily ) or a standard triple-drug cART regimen ( tenofovir disoproxil fumarate @ g plus emtricitabine @ g , darunavir @ g , and ritonavir @ g once daily ) using a predefined randomised list generated by randomly selected variable block sizes .


The primary endpoint was the median number of HIV-DNA copies per @ ( @ ) peripheral blood mononuclear cells ( PBMC ) at month @ , analysed in the modified intention-to-treat population , defined as all patients who started their assigned treatment .


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


Between April @ , @ , and July @ , @ , @ patients were enrolled , of whom @ were randomly assigned and @ started treatment ( @ in each treatment group ) .


Six ( @ % ) patients in the intensive cART group and two ( @ % ) in the standard cART group discontinued before month @ .


At month @ , HIV-DNA loads were similar between groups ( @ -LSB- IQR @-@ -RSB- log per @ ( @ ) PBMC in the intensive cART group vs @ -LSB- @-@ -RSB- in the standard cART group ; p = @ ) .


Eight grade @-@ clinical adverse events were reported in seven patients in the intensive cART group and seven grade @-@ clinical adverse events were reported in seven patients in the standard cART group .


Three serious clinical adverse events occurred : two ( pancreatitis and lipodystrophy ) in the standard cART group , which were regarded as treatment related , and one event ( suicide attempt ) in the intensive cART group that was unrelated to treatment .


After @ months , cART intensified with raltegravir and maraviroc did not have a greater effect on HIV blood reservoirs than did standard cART .


These results should help to design future trials of treatments aiming to decrease the HIV reservoir in patients with primary HIV-@ infection .


To test the effects of pregabalin on the induction of neurogenic claudication .


This study was a randomized , double-blind , active placebo-controlled , @-period , crossover trial .


Twenty-nine subjects were randomized to receive pregabalin followed by active placebo ( i.e. , diphenhydramine ) or active placebo followed by pregabalin .


Each treatment period lasted @ days , including a @-step titration .


Periods were separated by a @-day washout period , including a @-day taper phase after the first period .


The primary outcome variable was the time to first moderate pain symptom ( Numeric Rating Scale score @ ) during a @-minute treadmill test ( Tfirst ) .


Secondary outcome measures included pain intensity at rest , pain intensity at the end of the treadmill test , distance walked , and validated self-report measures of pain and functional limitation including the Roland-Morris Disability Questionnaire , modified Brief Pain Inventory-Short Form , Oswestry Disability Index , and Swiss Spinal Stenosis Questionnaire .


No significant difference was found between pregabalin and active placebo for the time to first moderate pain symptom ( difference in median Tfirst = -@ -LSB- @ % confidence interval -@ to @ -RSB- , p = @ ) .


In addition , none of the secondary outcome measures of pain or functional limitation were significantly improved by pregabalin compared with active placebo .


Pregabalin was not more effective than active placebo in reducing painful symptoms or functional limitations in patients with neurogenic claudication associated with lumbar spinal stenosis .


This study provides Class I evidence that for patients with neurogenic claudication , compared with diphenhydramine , pregabalin does not increase the time to moderate pain during a treadmill test .


A phase @ study was conducted to evaluate the bioavailability and food effect of a new veliparib formulation in subjects with solid tumors .


Subjects ( planned : Stage I , N = @ ; Stage II , N = @ ) received four regimens of a single oral dose of veliparib utilizing a group-sequential design .


Subjects were administered single doses of @ mg veliparib supplied as four @ mg current formulation , four @ mg new formulation and one @ mg new formulation under fasting conditions and under non-fasting conditions .


Serial blood samples were collected for the determination of veliparib pharmacokinetics .


At the end of Stage I , the relative bioavailability between each pair of regimens was assessed by a two one-sided tests procedure from the analyses of the natural logarithms of C ( max ) and AUC .


A @ % confidence interval within the @-@ @ range between each regimen pair determined bioequivalence .


Four @ mg current formulation capsules , four @ mg new formulation and one @ mg new formulation were bioequivalent with respect to C ( max ) and AUC under fasting conditions .


The administration of a high-fat meal did not have a significant effect on AUC and only caused a slight decrease in veliparib C ( max ) ( @ % ) and a delay of approximately @ h in T ( max ) .


The @ mg new capsule was bioequivalent to currently used formulation .


Food had no effect on the extent of veliparib absorption and only a small ( @ % ) decrease in peak exposure of veliparib .


Renin-angiotensin system inhibition ( RASI ) is frequently avoided in aortic stenosis ( AS ) patients because of fear of hypotension .


We evaluated if RASI with angiotensin-converting enzyme inhibitor ( ACEI ) or angiotensin receptor blocker ( ARB ) increased mortality in patients with mild to moderate AS .


All patients ( n = @ ) from the Simvastatin and Ezetimibe in Aortic Stenosis study : asymptomatic patients with AS and preserved left ventricular ( LV ) ejection fraction were included .


Risks of sudden cardiac death ( SCD ) , cardiovascular death and all-cause mortality according to RASI treatment were analyzed by multivariable time-varying Cox models and propensity score matched analyses .


@ ( @ % ) patients received RASI .


During a median follow-up of @ @ years , @ patients were categorized as having severe AS , @ underwent aortic valve replacement , @ SCDs , @ cardiovascular and @ all-cause deaths occurred .


RASI was not associated with SCD ( HR : @ -LSB- @ % CI : @-@ @ -RSB- , p = @ ) , cardiovascular ( HR : @ -LSB- @ % CI : @-@ @ -RSB- , p = @ ) or all-cause mortality ( HR : @ -LSB- @ % CI : @-@ @ -RSB- , p = @ ) .


This was confirmed in propensity matched analysis ( all p > @ ) .


In separate analyses , RASI was associated with larger reduction in systolic blood pressure ( p = @ ) and less progression of LV mass ( p = @ ) .


RASI was not associated with SCD , cardiovascular or all-cause mortality in asymptomatic AS patients .


However , RASI was associated with a potentially beneficial decrease in blood pressure and reduced LV mass progression .


Exercise capacity is a strong predictor of survival in patients with coronary artery disease ( CAD ) .


Exercise capacity improves after cardiac rehabilitation exercise training , but previous studies have demonstrated a decline in peak oxygen uptake after ending a formal rehabilitation program .


There is a lack of knowledge on how long-term exercise adherence can be achieved in CAD patients .


We therefore assessed if a @-month maintenance program following cardiac rehabilitation would lead to increased adherence to exercise and increased exercise capacity compared to usual care .


Two-centre , open , parallel randomized controlled trial with @ months follow-up comparing usual care to a maintenance program .


The maintenance program consisted of one monthly supervised high intensity interval training session , a written exercise program and exercise diary , and a maximum exercise test every third month during follow-up .


Forty-nine patients ( @ women ) on optimal medical treatment were included following discharge from cardiac rehabilitation .


The primary endpoint was change in peak oxygen uptake at follow-up ; secondary endpoints were physical activity level , quality of life and blood markers of cardiovascular risk .


There was no change in peak oxygen uptake from baseline to follow-up in either group ( intervention group @ ( @ ) to @ ( @ ) mLkg ( -@ ) min ( -@ ) , control group @ ( @ ) to @ ( @ ) mLkg ( -@ ) min ( -@ ) , with no between-group difference , p = @ ) .


Quality of life and blood biomarkers remained essentially unchanged , and both self-reported and measured physical activity levels were similar between groups after @ months .


A maintenance exercise program for @ months did not improve adherence to exercise or peak oxygen uptake in CAD patients after discharge from cardiac rehabilitation compared to usual care .


This suggests that infrequent supervised high intensity interval training sessions are inadequate to improve peak oxygen uptake in this patient group .


Early , goal-directed therapy ( EGDT ) is recommended in international guidelines for the resuscitation of patients presenting with early septic shock .


However , adoption has been limited , and uncertainty about its effectiveness remains .


We conducted a pragmatic randomized trial with an integrated cost-effectiveness analysis in @ hospitals in England .


Patients were randomly assigned to receive either EGDT ( a @-hour resuscitation protocol ) or usual care .


The primary clinical outcome was all-cause mortality at @ days .


We enrolled @ patients , with @ assigned to EGDT and @ to usual care .


By @ days , @ of @ patients ( @ % ) in the EGDT group and @ of @ patients ( @ % ) in the usual-care group had died ( relative risk in the EGDT group , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) , for an absolute risk reduction in the EGDT group of -@ percentage points ( @ % CI , -@ to @ ) .


Increased treatment intensity in the EGDT group was indicated by increased use of intravenous fluids , vasoactive drugs , and red-cell transfusions and reflected by significantly worse organ-failure scores , more days receiving advanced cardiovascular support , and longer stays in the intensive care unit .


There were no significant differences in any other secondary outcomes , including health-related quality of life , or in rates of serious adverse events .


On average , EGDT increased costs , and the probability that it was cost-effective was below @ % .


In patients with septic shock who were identified early and received intravenous antibiotics and adequate fluid resuscitation , hemodynamic management according to a strict EGDT protocol did not lead to an improvement in outcome .


( Funded by the United Kingdom National Institute for Health Research Health Technology Assessment Programme ; ProMISe Current Controlled Trials number , ISRCTN@ . )


To identify characteristics of hemodialysis patients most likely to experience difficulty adhering to sodium restrictions associated with their dietary regimen .


Secondary analysis using baseline data from an ongoing randomized clinical trial examining the effects of a technology-supported behavioral intervention on dietary sodium intake in hemodialysis patients .


Thirteen dialysis centers in southwestern Pennsylvania .


We included @ participants ( @ % women ; @ % African American ) aged @ @ years undergoing maintenance , intermittent hemodialysis for end-stage renal disease .


Normalized dietary sodium intake , adjusted interdialytic weight gain , perceived problems , and self-efficacy for restricting dietary sodium .


Younger participants were more likely to report problems managing their hemodialysis diet and low self-efficacy for restricting sodium intake .


Consistent with these findings , younger participants had a higher median sodium intake and higher average adjusted interdialytic weight gain .


Females reported more problems managing their diet .


Race , time on dialysis , and perceived income adequacy did not seem to influence outcome measures .


Our findings suggest that patients who are younger and female encounter more difficulty adhering to the hemodialysis regimen .


Hence , there may be a need to individualize counseling and interventions for these individuals .


Further investigation is needed to understand the independent effects of age and gender on adherence to hemodialysis dietary recommendations and perceived self-efficacy .


Ventricular and supraventricular premature complexes ( PC ) are frequent and usually symptomatic .


According to a previous study , magnesium pidolate ( MgP ) administration to symptomatic patients can improve the PC density and symptoms .


To assess the late follow-up of that clinical intervention in patients treated with MgP or placebo .


In the first phase of the study , @ symptomatic and consecutive patients with PC were randomized ( double-blind ) to receive either MgP or placebo for @ days .


Monthly follow-up visits were conducted for @ months to assess symptoms and control electrolytes .


@-hour Holter was performed twice , regardless of symptoms , or whenever symptoms were present .


In the second phase of the study , relapsing patients , who had received MgP or placebo ( crossing-over ) in the first phase , were treated with MgP according to the same protocol .


Of the @ patients initially treated with MgP , @ ( @ % ) relapsed during the @-month follow-up , and the relapse time varied .


Relapsing patients treated again had a statistically significant reduction in the PC density of @ / hour ( p < @ ) .


The crossing-over patients reduced it by @/hour ( p < @ ) .


Patients who did not relapse , had a low PC frequency ( @ PC/hour ) .


Retreated patients had a @ % improvement in symptom , and crossing-over patients , @ % .


Some patients on MgP had relapse of symptoms and PC , indicating that MgP is neither a definitive nor a curative treatment for late follow-up .


However , improvement in the PC frequency and symptoms was observed in the second phase of treatment , similar to the response in the first phase of treatment .


To compare the efficacy of an oscillating-rotating power toothbrush with a novel brush head incorporating angled CrissCross bristles ( Oral-B Pro @ SmartSeries and Oral-B CrossAction brush head ) versus a marketed sonic toothbrush ( Colgate ProClinical A@ with the Triple Clean brush head ) in the reduction of gingivitis and plaque over a @-week period .


This was a single center , randomized , open label , examiner-blind , @-treatment , parallel group study .


Study participants who met the entrance criteria were enrolled in the study and randomly assigned to one of the two toothbrush groups .


Study participants brushed with their assigned toothbrush and a marketed fluoride dentifrice for @ minutes twice daily at home for @ weeks .


Gingivitis and plaque were evaluated at baseline and Week @ .


Gingivitis was assessed using the Modified Gingival Index ( MGI ) and Gingival Bleeding Index ( GBI ) and plaque was assessed using the Rustogi Modified Navy Plaque Index ( RMNPI ) .


Data was analyzed using the ANCOVA with baseline as the covariate .


In total , @ study participants were randomized to treatment resulting in @ study participants per group completing the study .


Both brushes produced statistically significant ( P < @ ) reductions in gingivitis and plaque measures relative to baseline .


The oscillating-rotating , brush with the novel brush head demonstrated statistically significantly ( P < @ ) greater reductions in all gingivitis measures , as well as whole mouth and interproximal plaque measures , compared to the sonic toothbrush .


The benefit for the oscillating - rotating brush over the sonic brush was @ % for gingivitis , @ % for gingival bleeding , @ % for number of bleeding sites , @ % for whole mouth plaque , and @ % for interproximal plaque .


There were no adverse events reported or observed for either brush .


Value of information analysis has been proposed as an alternative to the standard hypothesis testing approach , which is based on type I and type II errors , in determining sample sizes for randomized clinical trials .


However , in addition to sample size calculation , value of information analysis can optimize other aspects of research design such as possible comparator arms and alternative follow-up times , by considering trial designs that maximize the expected net benefit of research , which is the difference between the expected cost of the trial and the expected value of additional information .


To apply value of information methods to the results of a pilot study on catheter securement devices to determine the optimal design of a future larger clinical trial .


An economic evaluation was performed using data from a multi-arm randomized controlled pilot study comparing the efficacy of four types of catheter securement devices : standard polyurethane , tissue adhesive , bordered polyurethane and sutureless securement device .


Probabilistic Monte Carlo simulation was used to characterize uncertainty surrounding the study results and to calculate the expected value of additional information .


To guide the optimal future trial design , the expected costs and benefits of the alternative trial designs were estimated and compared .


Analysis of the value of further information indicated that a randomized controlled trial on catheter securement devices is potentially worthwhile .


Among the possible designs for the future trial , a four-arm study with @ patients/arm would provide the highest expected net benefit corresponding to @ % return-on-investment .


The initially considered design of @ patients/arm , based on hypothesis testing calculations , would provide lower net benefit with return-on-investment of @ % .


Cost-effectiveness and value of information analyses were based on the data from a single pilot trial which might affect the accuracy of our uncertainty estimation .


Another limitation was that different follow-up durations for the larger trial were not evaluated .


The value of information approach allows efficient trial design by maximizing the expected net benefit of additional research .


This approach should be considered early in the design of randomized clinical trials .


To conduct a cost-effectiveness analysis comparing two different tooth replacement strategies for partially dentate older patients , namely partial removable dental prostheses ( RDP ) and functionally orientated treatment based on the shortened dental arch concept ( SDA ) .


Ninety-two partially dentate older patients completed a randomized controlled clinical trial .


Patients were randomly allocated to two treatment groups : the RDP group and the SDA group .


Treatment effect was measured using impact on oral health-related quality of life ( OHrQOL ) , and the costs involved in providing and maintaining care were recorded for all patients .


Patients were followed for @ months after treatment intervention .


All treatment was provided by a single operator .


The total cost of achieving the minimally important clinical difference ( MID ) in OHrQOL for an average patient in the RDP group was @ .


For the SDA group , the cost of achieving the MID for an average patient was @ .


The cost-effectiveness ratio was therefore @:@ in favour of SDA treatment .


With an increasingly ageing population , many patients will continue to benefit from removable prostheses to replace their missing natural teeth .


From a purely economic standpoint , the results from this analysis suggest that the treatment of partially dentate older adults should be focused on functionally orientated treatment because it is simply more cost-effective .


Previous reports suggest that adherence to patching is a major issue in amblyopia treatment .


We tested with an unmasked randomised controlled clinical trial whether an intense educational/motivational intervention improves adherence when a high-dose regime is prescribed .


@ children with newly diagnosed amblyopia were randomly allocated into two treatment arms with and without educational/motivational intervention material .


Both were prescribed patching @ h/day , @ days/week for a fixed period of @ weeks .


The intervention arm received an educational/motivational intervention before patching which included information booklets , video , a cartoon story book , sticker charts and a dedicated session with a researcher .


The control arm received the usual clinical information .


The primary outcome measure was adherence measured using electronic occlusion dose monitors where a success/failure binary outcome was used to account for participants who dropped out of the study defined as patching > @ h/day .


Visual outcome , expressed as percentage visual deficit , was measured as secondary outcome .


The intervention increased adherence success rate from @ % in the control group to @ % in the intervention group ( p = @ ) .


However , visual outcome was not significantly better in the intervention group ( p = @ ) .


Our study shows that an intense educational/motivational intervention can improve adherence to patching to high prescribed doses although no significant improvement in visual outcome was observed .


TRIALS REGISTRATION NUMBER : ISRCTN@ ( International Standard Randomised Controlled Trial Number Register ) .


Currently , there is an increased prevalence of diabetes mellitus among the elderly .


To minimize adverse effects on glycemic control , prevention and management of general and oral complications in diabetic patients is essential .


The purpose of the present study is to assess the effectiveness of a Lifestyle Change plus Dental Care ( LCDC ) program to improve glycemic and periodontal status in the elderly with type @ diabetes .


A quasi-experimental study was conducted in Health Centers @ ( intervention ) and @ ( control ) from October @ to January @ diabetic patients per health center were included .


At baseline , the intervention group attended a @ minute lifestyle and oral health education program , individual lifestyle counseling using motivational interviewing ( MI ) , application of self regulation manual , and individual oral hygiene instruction .


The intervention group received booster education every visit by viewing a @ minute educational video .


The control group received a routine program .


Participants were assessed at baseline and @ month follow up for glycosylated hemoglobin ( HbA@c ) , fasting plasma glucose ( FPG ) , body mass index ( BMI ) , periodontal status , knowledge , attitude and practice of oral health and diabetes mellitus .


Data were analyzed by using descriptive statistic , Chi-square test , Fisher 's exact test , t-test , and multiple linear regression .


After the @ month follow up , a multiple linear regression analysis showed that the intervention group was significantly negatively correlated in both glycemic and periodontal status .


Participants in the intervention group had significantly lower glycosylated hemoglobin ( HbA@c ) , fasting plasma glucose ( FPG ) , plaque index score , gingival index score , pocket depth , clinical attachment level ( CAL ) , and percentage of bleeding on probing ( BOP ) when compared to the control group .


The combination of lifestyle change and dental care in one program improved both glycemic and periodontal status in the elderly with type @ diabetes .


The aim of this study is to evaluate the effects of hormone replacement therapy using dienogest and medroxyprogesterone acetate on psychological symptoms in perimenopausal and postmenopausal women .


A total of @ patients who sought treatment at the menopause units of the authors ' gynecology and obstetrics clinics between of November @ and October @ complaining of vasomotor symptoms were included in the study prospectively .


The cases were divided into two groups : Group I ( @ patients ) was given @ mg estradiol valerate and @ mg dienogest , and Group II ( @ patients ) was given @ mg estradiol valerate and @ mg medroxyprogesterone acetate .


The groups ' results in months @ and @ were compared through the evaluation of vasomotor and psychological symptom levels .


No significant difference was found between the groups when the initial levels of vasomotor and psychological symptom subtypes were compared ( p = @ ) .


It was observed that all the psychological symptoms decreased in the @th month in the group using dienogest in comparison with the initial situation , and that psychological symptoms increased in the group using medroxyprogesterone acetate in the evaluation performed in the @th month compared with the initial levels .


It was also found out that there was a statistically significant difference between the two groups when compared in terms of these symptoms ( p < @ ) .


While the use of dienogest normalizes the general psychological situation and sleep , it was observed that the use of medroxyprogesterone acetate ( MPA ) worsens the general psychological situation .


Cross-sectional and retrospective studies have associated major depressive disorder with glial activation and injury as well as blood-brain barrier disruption , but these associations have not been assessed prospectively .


Here , we aimed to determine the relationship between changes in depressive symptom severity and in blood levels of S-@ calcium-binding protein B ( S-@B ) , high-sensitivity C-reactive protein , and interleukin-@ following an inflammatory challenge .


Fifty unselected participants were recruited from a randomized , controlled trial comparing coronary artery bypass grafting procedures performed with versus without cardiopulmonary bypass for the risk of neurocognitive decline .


Depressive symptom severity was measured at baseline , discharge , and six-month follow-up using the Beck Depression Inventory II ( BDI-II ) .


The primary outcome of the present biomarker study was acute change in depressive symptom severity , defined as the intra-subject difference between baseline and discharge BDI-II scores .


Blood biomarker levels were determined at baseline and @ days postoperative .


Changes in S-@B levels correlated positively with acute changes in depressive symptom severity ( Spearman , @ ; P = @ ) and accounted for about one-fourth of their observed variance ( R@ , @ ; P = @ ) .


This association remained statistically significant after adjusting for baseline S-@B levels , age , weight , body-mass index , or - blocker use , but not baseline BDI-II scores ( P = @ ) .


There was no statistically significant association between the primary outcome and baseline S-@B levels , baseline high-sensitivity C-reactive protein or interleukin-@ levels , or changes in high-sensitivity C-reactive protein or interleukin-@ levels .


Among most participants , levels of all three biomarkers were normal at baseline and markedly elevated at @ days postoperative .


Acute changes in depressive symptom severity were specifically associated with incremental changes in S-@B blood levels , largely independent of covariates associated with either .


These findings support the hypothesis that glial activation and injury and blood-brain barrier disruption can be mechanistically linked to acute exacerbation of depressive symptoms in some individuals .


We hypothesized that untreated severe obstructive sleep apnea ( OSA ) is associated with elevated ambulatory blood pressure ( BP ) in subjects with high cardiovascular disease ( CVD ) risk despite medical management .


Data from the baseline examination of the Heart Biomarker Evaluation in Apnea Treatment ( HeartBEAT ) study , a @-site randomized controlled trial were analyzed .


Individuals with moderate-severe OSA ( apnea hypopnea index , AHI = @-@ ) and cardiovascular risk were recruited from cardiology practices .


Those with hypertension were included .


Intensive antihypertensive regimen ( IAR ) was defined as @ antihypertensives including a diuretic .


Definitions were : controlled BP ( BP < @/@ ) , uncontrolled elevated BP ( BP @/@ not on IAR ) and resistant elevated BP ( BP @/@ mm Hg despite IAR ) .


Associations of untreated severe OSA ( AHI @ ) and uncontrolled and resistant elevated BP were evaluated using logistic regression analyses adjusted for age , sex , race , body mass index , smoking status , diabetes , and CVD .


Among the @ participants ( mean age @ @ years , @ % with severe OSA ) , @ % had controlled BP , @ % had uncontrolled elevated BP , and @ % had resistant elevated BP .


Among participants prescribed IAR , resistant elevated BP was more prevalent in those with severe compared to moderate OSA ( @ % vs. @ % , p = @ ) .


Participants with severe OSA had a @-fold higher adjusted odds of resistant elevated BP ( OR @ , @ % CI : @-@ @ ) , a finding not reproduced in the absence of IAR use .


Among patients with increased cardiovascular risk and moderate to severe OSA , untreated severe compared to moderate OSA was associated with elevated BP despite IAR suggesting untreated severe OSA contributes to poor BP control despite aggressive medication use .


A commentary on this article appears in this issue on page @ .


The aim of this study is to explore the efficacy and safety of the combination of autologous transplantation of granulocyte colony-stimulating factor ( G-CSF ) - mobilized peripheral blood mononuclear cells ( PBMNCs ) and Panax notoginseng saponins ( PNS ) in the treatment of unreconstructable critical limb ischemia ( CLI ) .


We performed an open-label , parallel-group , single-center , randomized clinical trial in this study .


A total of @ patients were enrolled and randomly divided into @ groups ( the PBMNC + PNS group and the PBMNC group ) in a @:@ ratio .


Evaluation variables , including changes in the ankle-brachial index ( ABI ) of ischemic limbs , ulcer area , severity of rest pain , transcutaneous oxygen pressure ( T ( C ) PO@ ) , and @-min walk distance from baseline to week @ and @ , as well as angiographic scores for new collateral vessel formation at week @ , were used to compare the benefits of these @ treatment approaches .


After @ weeks of treatment , improvement in ABI , T ( C ) PO@ , and @-min walk distance was significantly better in the PBMNC + PNS group .


In addition , the combination of PBMNC transplantation and PNS administration yielded a greater reduction in ulcer area and severity of rest pain than did PBMNC transplantation alone .


The proportion of patients experiencing any adverse event was similar between both treatment groups .


Adverse events caused by PBMNC transplantation or PNS were generally mild and no serious adverse events occurred throughout the entire period of study .


A combination of PNS and PBMNC transplantation appears to be a safe and effective treatment for patients with unreconstructable CLI .


This combination may have great potential advantages in comparison with PBMNC transplantation alone and might constitute a novel therapeutic option for unreconstructable CLI .


Bone marrow ( BM ) dysfunction is common in severely injured trauma patients , resulting from elevated catecholamines and plasma granulocyte colony-stimulating factor ( G-CSF ) as well as prolonged mobilization of hematopoietic progenitor cells ( HPCs ) .


We have previously shown that propranolol ( - blocker -LSB- BB -RSB- ) reduces HPC mobilization in a rodent model of injury and hemorrhagic shock .


We hypothesize that BB would prevent BM dysfunction in humans following severe injury .


Forty-five severely injured trauma patients were studied in a prospective , randomized pilot trial .


Twenty-five patients received BB , and @ served as untreated controls .


The dose of propranolol was adjusted to decrease the heart rate by @ % to @ % from baseline .


Blood was analyzed for the presence of HPC ( blast-forming unit erythroid cells -LSB- BFU-E -RSB- and colony-forming unit erythroid cells ) and G-CSF .


Demographic data , Injury Severity Score ( ISS ) , hemoglobin , reticulocyte number , and outcome data were obtained .


The mean age of the study population was @ years ; @ % were male , with a mean ISS of @ .


There is a significant increase in BFU-E in peripheral blood immediately following traumatic injury , and this mobilization persists for @ days .


The use of BB significantly decreases BFU-E and colony-forming unit erythroid cells at all time points .


G-CSF is significantly elevated in both groups on admission ; the use of BB decreases G-CSF levels by @ % as compared with @ % for controls .


The average hemoglobin is nearly @ g higher on the day of discharge with propranolol treatment ( BB , @ @ g/dL vs. no BB , @ @ g/dL ) .


Following severe trauma , early treatment with propranolol following resuscitation is safe .


The use of propranolol blunts early tachycardia , reduces HPC mobilization , and results in a faster return to baseline of the G-CSF peak seen after injury .


There is also a trend toward faster recovery and resolution of anemia .


Propranolol may be the first therapeutic agent to show improved BM function after severe injury .


Therapeutic study , level III .


Despite evidence for the effectiveness of structured psychological therapies for bipolar disorder no psychological interventions have been specifically designed to enhance personal recovery for individuals with recent-onset bipolar disorder .


A pilot study to assess the feasibility and effectiveness of a new intervention , recovery-focused cognitive-behavioural therapy ( CBT ) , designed in collaboration with individuals with recent-onset bipolar disorder intended to improve clinical and personal recovery outcomes .


A single , blind randomised controlled trial compared treatment as usual ( TAU ) with recovery-focused CBT plus TAU ( n = @ ) .


Recruitment and follow-up rates within @ % of pre-planned targets to @-month follow-up were achieved .


An average of @ h ( s.d. = @ ) of recovery-focused CBT were attended out of a potential maximum of @ h. Compared with TAU , recovery-focused CBT significantly improved personal recovery up to @-month follow-up ( Bipolar Recovery Questionnaire mean score @ , @ % CI @-@ @ ( s.e. = @ ) , P = @ , d = @ ) and increased time to any mood relapse during up to @ months follow-up ( @ = @ , P < @ , estimated hazard ratio ( HR ) = @ , @ % CI @-@ @ ) .


Groups did not differ with respect to medication adherence .


Recovery-focused CBT seems promising with respect to feasibility and potential clinical effectiveness .


Clinical - and cost-effectiveness now need to be reliably estimated in a definitive trial .


Tofacitinib is a novel , oral Janus kinase inhibitor being investigated for psoriasis .


This study assessed the relationship between pruritus and clinical signs of psoriasis ( assessed by Physician 's Global Assessment -LSB- PGA -RSB- ) in patients with moderate-to-severe chronic plaque psoriasis receiving tofacitinib .


In this @-week ( @-week treatment period , @-week observation period ) , double-blind , placebo-controlled , phase IIb study ( NCT@ ) , @ patients were randomized to tofacitinib @ , @ or @ mg BID , or placebo .


Pruritus was patient assessed using the Itch Severity Score ( ISS ) , a @-@ ( @ = worst itching ) rating scale recorded daily from baseline to week @ and at study visits .


Mediation modeling was used to determine relationships between ISS ( average score weeks @-@ ) , PGA ( average score weeks @-@ ) and treatment groups .


Mediation analysis showed that @-@ @ % ( p < @ versus placebo ) of tofacitinib 's effect on pruritus was direct , and mostly independent of improvements in erythema , induration and scaling .


ISS measurements had acceptable test-retest reliability .


Correlation analyses with clinical outcomes supported the validity of the ISS as a pruritus measure .


Tofacitinib has a direct , beneficial effect on patient-reported pruritus independent from improvements in clinician-reported psoriasis severity signs .


The ISS demonstrated favorable psychometric characteristics , supporting its use as a pruritus assessment tool .


Despite the widespread recognition that obesity in pregnant women is associated with adverse outcomes for mother and child , there is no intervention proven to reduce the risk of these complications .


The primary aim of this randomised controlled trial is to assess in obese pregnant women , whether a complex behavioural intervention , based on changing diet ( to foods with a lower glycemic index ) and physical activity , will reduce the risk of gestational diabetes ( GDM ) and delivery of a large for gestational age ( LGA ) infant .


A secondary aim is to determine whether the intervention lowers the long term risk of obesity in the offspring .


Multicentre randomised controlled trial comparing a behavioural intervention designed to improve glycemic control with standard antenatal care in obese pregnant women.Inclusion criteria ; women with a BMI @ kg/m@ and a singleton pregnancy between @ +@ weeks and @ +@ weeks ' gestation .


Exclusion criteria ; pre-defined , pre-existing diseases and multiple pregnancy .


Randomisation is on-line by a computer generated programme and is minimised by BMI category , maternal age , ethnicity , parity and centre .


Intervention ; this is delivered by a health trainer over @ sessions .


Based on control theory , with elements of social cognitive theory , the intervention is designed to improve maternal glycemic control .


Women randomised to the control arm receive standard antenatal care until delivery according to local guidelines .


All women have a @ g oral glucose tolerance test at @ +@ - @ +@ weeks ' gestation.Primary outcome ; Maternal : diagnosis of GDM , according to the International Association of Diabetes in Pregnancy Study Group ( IADPSG ) criteria .


Neonatal ; infant LGA defined as > @th customised birth weight centile.Sample size ; @ women to provide @ % power to detect a @ % reduction in the incidence of GDM and a @ % reduction in infants large for gestational age .


All aspects of this protocol have been evaluated in a pilot randomised controlled trial , with subsequent optimisation of the intervention .


The findings of this trial will inform whether lifestyle mediated improvement of glycemic control in obese pregnant women can minimise the risk of pregnancy complications .


Animal-assisted therapy ( AAT ) , most frequently used with dogs , is being used increasingly as an adjunctive alternative treatment for psychiatric patients .


AAT with larger animals , such as horses , may have unique benefits .


In this randomized controlled study , equine and canine forms of AAT were compared with standard treatments for hospitalized psychiatric patients to determine AAT effects on violent behavior and related measures .


The study included @ patients with recent in-hospital violent behavior or highly regressed behavior .


Hospitalization at the @-bed state psychiatric hospital was two months or longer ( mean @ years ) .


Participants were randomly selected to receive ten weekly group therapy sessions of standardized equine-assisted psychotherapy ( EAP ) , canine-assisted psychotherapy ( CAP ) , enhanced social skills psychotherapy , or regular hospital care .


Participants ' mean age was @ , @ % were female , @ % had diagnoses of schizophrenia or schizoaffective disorder , and @ % had been committed involuntarily for civil or forensic reasons .


Violence-related incident reports filed by staff in the three months after study intake were compared with reports two months preintake .


Interventions were well tolerated .


Analyses revealed an intervention group effect ( F = @ , df = @ and @ , p = @ ) ; post hoc tests showed specific benefits of EAP ( p < @ ) .


Similar AAT effects were found for the incidence of @:@ clinical observation ( F = @ , df = @ and @ , p = @ ) ; post hoc tests suggested benefits of CAP ( p = @ ) as well as EAP ( p = @ ) .


Covariance analyses indicated that staff can predict which patients are likely to benefit from EAP ( p = @ ) .


AAT , and perhaps EAP uniquely , may be an effective therapeutic modality for long-term psychiatric patients at risk of violence .


Knowledge about the inhibition of centrally located angiotensin-I ( AT-I ) receptors by highly lipophilic AT-I receptor blockers and its ' effect are limited with experimental studies .


Thus , we aimed to investigate the effect of Telmisartan on Inter-dialytic weight gain ( IDWG ) % and echocardiographic measurements in anuric hemodialysis ( HD ) patients .


A total of forty-one anuric HD patients with @ months maintenance on HD were included in this prospective , randomized and self-controlled study .


Four weeks prior the study , angiotensin converting enzyme blockers and AT-I receptor blocker drugs were stopped .


Patients were assessed three times during the study protocol .


These are baseline , three months later ( without Telmisartan period ) and three months after Telmisartan therapy .


IDWG % was significantly decreased in the period of with Telmisartan compared to period without Telmisartan ( @ @ % vs @ @ % , p = @ ) .


After the administration of Telmisartan left ventricule end-diastolic diameter ( LVEDD ) ( p = @ ) and inferior vena cava diameter ( IVCD ) ( @ @ mm vs @ @ mm , p = @ ) were significantly decreased compared to the period of without Telmisartan .


Despite of significantly changes observed in IVCD and LVEDD measurements in a period without Telmisartan , there was no significantly difference in left ventricular mass index ( LVMI ) measurements in this period .


However , LVMI was significantly regressed after the administration of Telmisartan ( @ @ g vs @ @ g , p = @ respectively ) .


Treatment of anuric HD patients with Telmisartan at a dose of @ mg a day reduces IDWG % , LVEDD and IVCD measurements .


Further studies investigating the long-term effect of these beneficial effects on clinical outcomes are necessary .


There are currently no serum biomarkers capable of distinguishing elevations in serum alanine aminotransferase ( ALT ) that portend serious liver injury potential from benign elevations such as those occurring during cholestyramine treatment .