Our results indicate that skeletonization of ITA significantly reduces postcoronary artery bypass graft surgery pain at both one - and three-month intervals .


Long-term clinical trials involving larger sample sizes should be conducted to fully confirm the benefits of the skeletonization technique .


Allergen-specific immunotherapy ( SIT ) is the only intervention for IgE-mediated respiratory disorders .


The aim of the study was to investigate the immunological modifications induced by SIT in patients allergic to olive and/or grass pollen by attempting to establish an association between these modifications and clinical improvements .


We studied 29 patients who were allergic to olive and/or grass pollen .


Patients were randomized to 2 groups : an active treatment group , comprising 19 allergic patients who received SIT , and a control group , formed by 10 allergic patients who received pharmacological treatment for their allergic symptoms but not immunotherapy .


We used flow cytometry to analyze intracellular expression of the cytokines IL-4 , IFN-gamma , IL-10 , and TGF-beta1 in CD4 + T cells , as well as expression of Foxp3 , the costimulatory CTLA-4 molecule , and the non-costimulatory CD40L molecule .


To assess clinical changes , patients recorded their medication consumption , symptoms , and the limitation of daily activities using diary cards and quality of life questionnaires .


Six months after initiation of SIT , we recorded a reduction in cell surface CD40L expression in the CD4 + T-cell population and a shift in the cytokine production profile ( decrease in IL-4-producing CD4 + T cells and increase in IFN-gamma , IL-10 , and TGF-beta1 ) .


These changes persisted after 12 months .


Simultaneously , a clinical improvement was observed .


SIT-induced clinical improvement is the result of immunological modifications such as a reduction in CD40L expression on CD4 cells and alteration in the cytokine production profile .


The luteal menstrual phase might be a favorable time for smoking cessation when non-nicotine interventions ( e.g. counseling , bupropion ) are used , whereas the follicular menstrual phase appears favorable when nicotine interventions are used .


Thus , there may be an interaction between menstrual phase and response to nicotine .


We sought to examine the role of menstrual phase on response to nicotine during acute smoking abstinence .


In this controlled cross-over trial , women completed two identical experimental sessions ( follicular [ F ] vs. luteal [ L ] phase ) after four days of biochemically-verified smoking abstinence .


During the sessions , nicotine nasal spray was administered , and participants provided a series of subjective assessments .


Participants ( n = 140 ) were 29.76.6 years old and smoked 12.65.8 cigarettes per day .


Compared to the F phase , the L phase was associated with a greater increase in stimulation ( 7.22.2 vs. 14.42.3 , p = 0.01 , respectively ) and greater decrease in urge to smoke ( -13.62.3 vs. -21.12.5 , p = 0.02 , respectively ) after the first dose of nicotine .


No other significant differences were observed .


Out of 13 total measures examined at two different time points , we observed only two significant menstrual phase differences in the subjective response to nicotine .


Therefore , these data do not provide strong evidence for a menstrual phase difference in the subjective response to nicotine .


Additional research is needed to confirm this relationship and explore how non-nicotine smoking reinforcements ( such as sensory sensations ) may vary by menstrual phase .


To compare the outcomes of congenital cataract surgery using intraoperative intracameral triamcinolone versus postoperative oral prednisolone to modulate ocular inflammation .


Department of Congenital Cataract , Altino Ventura Foundation , Recife , Brazil .


Randomized clinical trial .


Children younger than 2 years were randomly divided into 2 groups .


The study group received an intraoperative intracameral injection of 1.2 mg/0 .03 mL of triamcinolone acetonide .


The control group ( 29 eyes ) received 1 mg/kg per day of prednisolone syrup for 15 days postoperatively , which was then tapered over the following 2 weeks .


Intraocular pressure ( IOP ) , central corneal thickness ( CCT ) , cell deposits on the intraocular lens ( IOL ) , posterior synechiae , visual axis obscuration , additional surgical procedures , and IOL centration were assessed 12 months postoperatively .


The mean patient age at surgery was 10.45 months6 .22 ( SD ) in the study group ( 31 eyes ) and 10.06.15 months in the control group ( 29 eyes ) ( P = .779 ) .


In both groups , the mean IOP and CCT did not change significantly postoperatively ( study group P = .922 and P = .149 , respectively ; control group P = .483 and P = .416 , respectively ) .


The groups had similar incidences of cell deposits ( P = .517 ) and posterior synechiae ( P = .247 ) .


No eye developed visual axis obscuration or had additional surgical procedures .


All eyes had a clinically centered IOL .


One year postoperatively , the outcomes were similar with intraoperative intracameral triamcinolone injection and postoperative oral prednisolone for modulating inflammation after congenital cataract surgery .


No author has a financial or proprietary interest in any material or method mentioned .


To assess the effect of preventive pravastatin treatment on coronary heart disease ( CHD ) morbidity and mortality in older persons at risk for cardiovascular disease ( CVD ) , stratified according to plasma levels of homocysteine .


A post hoc subanalysis in the PROspective Study of Pravastatin in the Elderly at Risk ( PROSPER ) , started in 1997 , which is a double-blind , randomized , placebo-controlled trial with a mean follow-up of 3.2 years .


Primary care setting in two of the three PROSPER study sites ( Netherlands and Scotland ) .


Individuals ( n = 3,522 , aged 70-82 , 1,765 male ) with a history of or risk factors for CVD were ranked in three groups depending on baseline homocysteine level , sex , and study site .


Pravastatin ( 40 mg ) versus placebo .


Fatal and nonfatal CHD and mortality .


In the placebo group , participants with a high homocysteine level ( n = 588 ) had a 1.8 higher risk ( 95 % confidence interval ( CI ) = 1.2-2 .5 , P = .001 ) of fatal and nonfatal CHD than those with a low homocysteine level ( n = 597 ) .


The absolute risk reduction in fatal and nonfatal CHD with pravastatin treatment was 1.6 % ( 95 % CI = -1.6 to 4.7 % ) in the low homocysteine group and 6.7 % ( 95 % CI = 2.7-10 .7 % ) in the high homocysteine group ( difference 5.2 % , 95 % CI = 0.11-10 .3 , P = .046 ) .


Therefore , the number needed to treat ( NNT ) with pravastatin for 3.2 years for benefit related to fatal and nonfatal CHD events was 14.8 ( 95 % CI = 9.3-36 .6 ) for high homocysteine and 64.5 ( 95 % CI = 21.4 - ) for low homocysteine .


In older persons at risk of CVD , those with high homocysteine are at highest risk for fatal and nonfatal CHD .


With pravastatin treatment , this group has the highest absolute risk reduction and the lowest NNT to prevent fatal and nonfatal CHD .


Current parameters for assessing the efficacy of actinic keratosis ( AK ) treatments compare clinical lesions at the start and end of a study .


However , the sun-exposed field also contains subclinical lesions which may become detectable during treatment .


Lmax , the maximum lesion count during treatment , is a new concept to better assess the efficacy of field-directed AK therapies .


Measuring efficacy using the reduction in lesions from Lmax includes for the first time the clearance of both subclinical and clinical lesions .


To evaluate the reduction of lesions from Lmax to study end and compare the results with traditional efficacy endpoints using imiquimod 3.75 % ( IQ3 .75 % ) as an example of field-directed AK therapy .


Pooled analysis of data from two 14-week , vehicle-controlled , double-blind studies of IQ3 .75 % .


With IQ3 .75 % , the median number of lesions increased from 10 at baseline to an Lmax of 22 .


The median absolute reduction in lesions to study end was 18 from Lmax versus 7 from baseline .


The median percentage reduction in AK lesions to study end was 92.2 % from Lmax compared with 81.8 % from baseline .


The reduction in lesion count from Lmax is a novel efficacy parameter that should become the new way of evaluating field-directed AK therapies since it enables their efficacy against both clinical and subclinical lesions to be accurately determined .


Together , the Lmax concept and IQ3 .75 % represent a new approach for the management of AK across a large sun-exposed field .


Individual work performance is an important outcome measure in studies in the workplace .


Nevertheless , its conceptualization and measurement has proven challenging .


To overcome limitations of existing scales , the Individual Work Performance Questionnaire ( IWPQ ) was recently developed .


The aim of the current study was to gain insight into the responsiveness of the IWPQ .


Data were used from the Be Active & Relax randomized controlled trial .


The aim of the trial was to investigate the effectiveness of an intervention to stimulate physical activity and relaxation of office workers , on need for recovery .


Individual work performance was a secondary outcome measure of the trial .


In total , 39 hypotheses were formulated concerning correlations between changes on the IWPQ scales and changes on similar constructs ( e.g. , presenteeism ) and distinct constructs ( e.g. , need for recovery ) used in the trial .


260 Participants completed the IWPQ at both baseline and 12 months of follow-up .


For the IWPQ scales , 23 % , 15 % , and 38 % , respectively , of the hypotheses could be confirmed .


In general , the correlations between change scores were weaker than expected .


Nevertheless , at least 85 % of the correlations were in the expected direction .


Based on results of the current study , no firm conclusions can be drawn about the responsiveness of the IWPQ .


Several reasons may account for the weaker than expected correlations .


Future research on the IWPQ 's responsiveness should be conducted , preferably in other populations and intervention studies , where greater changes over time can be expected .


To determine the efficacy of topical application of the autologous platelet gel ( PG ) in canine chronic protracted decubital ulcers .


Prospective , randomized , blind controlled clinical trial .


Dogs ( n = 18 ) with bilateral chronic wounds caused by protracted decubitus ulcers .


For each dog , wound side was randomized to receive either platelet gel ( group PG ) every 5 days for 5 dressing changes , or paraffin gauzes dressings ( group C ) , as negative control .


Wound healing and wound surfaces were compared at admission and then evaluated every 5th day , until day 25 .


Outcome variables were : open wound area , reduction of open wound surface compared to admission and to each preceding dressing change , time to complete epithelialization .


Significant differences in healing process were observed at day 5 and continued throughout the entire study period ( P < .00001 ) .


At 25 days , mean percent reduction in wound area was 93.5 % in group PG and 13.2 % in group C ( P < .00001 ) .


Appropriately prepared autologous PG , an inexpensive , readily available blood derivative , applied topically results in more rapid healing of chronic non-healing decubital ulcers in dogs than those treated by use of paraffin-impregnated gauzes .


The randomised phase III TURANDOT trial compared first-line bevacizumab-paclitaxel ( BEV-PAC ) vs bevacizumab-capecitabine ( BEV-CAP ) in HER2-negative locally recurrent/metastatic breast cancer ( LR/mBC ) .


The interim analysis revealed no difference in overall survival ( OS ; primary end point ) between treatment arms ; however , progression-free survival ( PFS ) and objective response rate were significantly superior with BEV-PAC .


We sought to identify patient populations that may be most appropriately treated with one or other regimen .


Patients with HER2-negative LR/mBC who had received no prior chemotherapy for advanced disease were randomised to either BEV-PAC ( bevacizumab 10 mg kg ( -1 ) days 1 and 15 plus paclitaxel 90 mg m ( -2 ) days 1 , 8 and 15 q4w ) or BEV-CAP ( bevacizumab 15 mg kg ( -1 ) day 1 plus capecitabine 1000 mg m ( -2 ) bid days 1-14 q3w ) .


The study population was categorised into three cohorts : triple-negative breast cancer ( TNBC ) , high-risk hormone receptor-positive ( HR + ) and low-risk HR + .


High - and low-risk HR + were defined , respectively , as having 2 vs 1 of the following four risk factors : disease-free interval 24 months ; visceral metastases ; prior ( neo ) adjuvant anthracycline and/or taxane ; and metastases in 3 organs .


The treatment effect on OS differed between cohorts .


Non-significant OS trends favoured BEV-PAC in the TNBC cohort and BEV-CAP in the low-risk HR + cohort .


In all three cohorts , there was a non-significant PFS trend favouring BEV-PAC .


Grade 3 adverse events were consistently less common with BEV-CAP .


A simple risk factor index may help in selecting bevacizumab-containing regimens , balancing outcome , safety profile and patient preference .


Final OS results are expected in 2015 ( ClinicalTrials.gov NCT00600340 ) .


The present study aims to explore the effects of vitamin E and omega-3 on endothelial function indicators among adolescents with metabolic syndrome .


In a randomized , double blind , and placebo-controlled trial , 90 young individuals , aged 10 to 18 years , with metabolic syndrome were randomly assigned to receive either vitamin E tablets ( 400IU/day ) or omega-3 tablets ( 2.4 gr/day ) or placebo .


For assessing endothelial functional state , the serum level of vascular endothelial growth factor ( VEGF ) was measured by ELISA test .


The use of omega-3 supplementation for eight weeks led to significant increase in serum HDL level compared with the group treated with vitamin E or placebo group .


In this regard , no significant correlations were found between the change in VEGF and baseline levels of other markers including anthropometric indices and serum lipids .


Omega-3 could significantly reduce VEGF with the presence of other baseline variables ( Beta = -12.55 ; P = 0.012 ) .


The administration of omega-3 can effectively improve endothelial function in adolescents with metabolic syndrome by reducing the level of serum VEGF , as a major index for atherosclerosis progression and endothelial destabilization .


Omega-3 can be proposed as a VEGF antagonist for improving endothelial function in metabolic syndrome .


The clinical implications of our findings should be assessed in future studies .


To evaluate the 5-year efficacy and safety of once weekly exenatide .


The Diabetes Therapy Utilization : Researching Changes in A1C , Weight and Other Factors Through Intervention with Exenatide Once Weekly ( DURATION-1 ) randomized clinical trial consisted of a 30-week controlled phase ( 2 mg of exenatide once weekly vs 10 g of exenatide twice daily ) with an open-ended uncontrolled extension ( once weekly exenatide only ) in patients with type 2 diabetes mellitus on background glucose-lowering therapies ( April 15 , 2006 , through February 21 , 2012 ) .


At week 30 , patients initially receiving 10 g of exenatide twice daily switched to 2 mg of exenatide once weekly .


Study end points included changes from baseline in hemoglobin A1c , fasting plasma glucose , weight , lipids , and blood pressure .


Long-term safety data included adverse events , liver and renal function , and heart rate .


Of 258 extension-phase patients , 153 ( 59.3 % ) completed 5 years of treatment .


Hemoglobin A1c levels were significantly and durably reduced from baseline ( least-squares mean , -1.6 % ; 95 % CI , -1.8 % to -1.4 % ; vs -1.9 % for exenatide once weekly at week 30 ) , and 65 ( 43.9 % ) of 148 patients achieved hemoglobin A1c levels of less than 7.0 % .


Significant improvements in fasting plasma glucose level ( -28.8 mg/dL ; 95 % CI , -36.2 to -21.5 mg/dL ) , weight ( -3.0 kg ; 95 % CI , -4.6 to -1.3 kg ) , lipids , and diastolic blood pressure were observed , with minimal heart rate increase .


Frequencies of nausea and injection-site reactions or nodules were decreased vs the initial 30-week controlled phase .


Minor hypoglycemia occurred predominantly with sulfonylurea use , and no major hypoglycemia or new safety signals were observed .


Long-term once weekly exenatide treatment was generally well tolerated with sustained glycemic improvement , weight reduction , and improved markers of cardiovascular risk in patients with type 2 diabetes .


clinicaltrials.gov Identifier : NCT00308139 .


The use of single-port laparoscopy for left-lateral liver sectionectomy ( LLLS ) has been reported in the literature , but the effectiveness and safety of LLLS has not been validated in randomized , controlled trials .


This prospective randomized controlled trial compared the effectiveness and safety of single-port and multi-port laparoscopic LLLS for the surgical treatment of benign liver disease .


Altogether , 38 patients aged 17-65 years ( 16 men , 22 women ) with benign liver diseases were hospitalized for elective laparoscopic LLLS between January 2010 and December 2012 .


Patients were randomly assigned to either single-port ( n = 19 ) or multi-port ( n = 19 ) laparoscopic LLLS .


Main outcome measures were operative time , volume of intraoperative blood loss , complication rates , and postoperative hospitalization .


Baseline characteristics of the two groups were comparable .


Single-port and multi-port laparoscopies were successfully completed in all but one patient ( 1/19 , 5.3 % ) who required conversion from a single-port to a multi-port procedure .


The two groups had similar mean operative times and volumes of intraoperative blood loss .


There were no clinically significant postoperative complications or deaths .


The single-port group had a significantly shorter postoperative hospitalization than the multi-port group ( 2.5 1.7 vs. 4.0 2.1 days ; p < 0.05 ) .


Single-port laparoscopic LLLS is a technically feasible , effective , safe alternative to multi-port laparoscopy for the treatment of benign liver diseases in cautiously selected patients .


Behavioral interventions for obesity are commonly delivered in groups , although the effect of group size on weight loss has not been empirically evaluated .


This behavioral weight loss trial compared the 6 - and 12-month weight changes associated with interventions delivered in a large group ( LG ) or small groups ( SG ) .


Obese adults ( N = 66 ; mean age = 50 years ; mean BMI = 36.5 kg/m2 ; 47 % African American ; 86 % women ) recruited from a health maintenance organization were randomly assigned to : ( 1 ) LG treatment ( 30 members/group ) , or ( 2 ) SG treatment ( 12 members/group ) .


Conditions were comparable in frequency and duration of treatment , which included 24 weekly group sessions ( months 1-6 ) followed by six monthly extended care contacts ( months 7-12 ) .


A mixed effects model with unstructured covariance matrix was applied to analyze the primary outcome of weight change while accounting for baseline weight and dependence among participants ' measurements over time .


SG participants lost significantly more weight than LG participants at Month 6 ( -6.5 vs. -3.2 kg ; p = 0.03 ) and Month 12 ( -7.0 vs. -1.7 kg ; p < 0.002 ) .


SG participants reported better treatment engagement and self-monitoring adherence at Months 6 and 12 , ps < 0.04 , with adherence fully mediating the relationship between group size and weight loss .


Receiving obesity treatment in smaller groups may promote greater weight loss and weight loss maintenance .


This effect may be due to improved adherence facilitated by SG interactions .


These novel findings suggest that the perceived efficiency of delivering behavioral weight loss treatment to LGs should be balanced against the potentially better outcomes achieved by a SG approach .


This research was conducted with the aim of determining the influence of three different oral care solutions on oral mucous membrane integrity in critically ill patients .


Oral care is a basic part of nursing care in intensive care units .


A randomized controlled trial was conducted .


A total of 60 patients ( 20 patients in each group ) comprised the study sample of the research .


Patients were randomly allocated to three groups .


Patients in groups 1 , 2 and 3 were administered mouth care three times a day using 5 % sodium bicarbonate , 02 % chlorhexidine and saline solution , respectively .


Data were collected by means of a ` Descriptive characteristics form ' and an ` oral assessment tool ' .


Mean scores of oral assessment tool increased according to days in all groups , however , this increase was found to be statistically insignificant ( p > 005 ) .


Mean scores of the patients in saline solution group were seen to be lower than those of the other groups .


When inter-group comparison of days was done , the difference between oral assessment scores was found to be statistically significant ( p = 0000 ) .


It was found that there was no difference between patient groups receiving saline solution , sodium bicarbonate and 02 % chlorhexidine for mouth care in terms of oral mucous membrane integrity ; oral mucosa of all patients was found to be mildly dysfunctioning .


It is thought that standardized protocols for oral hygiene developed in the light of the findings of randomized controlled trials may improve the oral health in critically ill patients .


Angina pectoris is common in patients with heart failure and reduced ejection fraction ( HF-REF ) but its relationship with outcomes has not been well defined .


This relationship was investigated further in a retrospective analysis of the Controlled Rosuvastatin Multinational Trial in Heart Failure ( CORONA ) .


Four thousand , eight hundred and seventy-eight patients were divided into three categories : no history of angina and no chest pain at baseline ( Group A ; n = 1240 ) , past history of angina but no chest pain at baseline ( Group B ; n = 1353 ) and both a history of angina and chest pain at baseline ( Group C ; n = 2285 ) .


Outcomes were examined using Kaplan-Meier and Cox regression survival analysis .


Compared with Group A , Group C had a higher risk of non-fatal myocardial infarction or unstable angina ( HR : 2.36 , 1.54-3 .61 ; P < 0.001 ) , this composite plus coronary revascularization ( HR : 2.54 , 1.76-3 .68 ; P < 0.001 ) , as well as HF hospitalization ( HR : 1.35 , 1.13-1 .63 ; P = 0.001 ) , over a median follow-up period of 33 months .


There was no difference in cardiovascular or all-cause mortality .


Group B had a smaller increase in risk of coronary events but not of heart failure hospitalization .


Patients with HF-REF and ongoing angina are at an increased risk of acute coronary syndrome and HF hospitalization .


Whether these patients would benefit from more aggressive medical therapy or percutaneous revascularization is not known and merits further investigation .


Primary cardiovascular prevention may be achieved by lifestyle/nutrition improvements and specific drugs , although a relevant role is now emerging for specific functional foods and nutraceuticals .


The aim of this study was to evaluate the usefulness of a nutraceutical multitarget approach in subjects with moderate cardiovascular risk and to compare it with pravastatin treatment .


Thirty patients with moderate dyslipidemia and metabolic syndrome ( according to the Third Report of the National Cholesterol Education Program Expert Panel on Detection , Evaluation , and Treatment of High Blood Cholesterol in Adults ) were included in an 8-week randomized , double-blind crossover study and took either placebo or a nutraceutical combination that contained red yeast rice extract , berberine , policosanol , astaxanthin , coenzyme Q10 , and folic acid ( Armolipid Plus ) .


Subsequently , they were subjected to another 8-week treatment with pravastatin 10 mg/d .


This dosage was selected on the basis of its expected -20 % efficacy in reducing low-density lipoprotein-cholesterol .


Treatment with Armolipid Plus led to a significant reduction of total cholesterol ( -12.8 % ) and low-density lipoprotein-cholesterol ( -21.1 % ) , similar to pravastatin ( -16 % and -22.6 % , respectively ) , and an increase of high-density lipoprotein-cholesterol ( 4.8 % ) .


Armolipid Plus improved the leptin-to-adiponectin ratio , whereas adiponectin levels were unchanged .


These results indicate that this nutraceutical approach shows a lipid-lowering activity comparable to pravastatin treatment .


Hence , it may be a safe and useful option , especially in conditions of moderate cardiovascular risk , in which a pharmacologic intervention may not be appropriate .


Despite the prevalence and the functional , psychological , and economic impact of chronic pain , few intervention studies of treatment of chronic pain in veterans have been performed .


To determine whether a stepped-care intervention is more effective than usual care , as hypothesized , in reducing pain-related disability , pain interference , and pain severity .


We performed a randomized clinical trial comparing stepped care with usual care for chronic pain .


We enrolled 241 veterans from Operation Enduring Freedom , Operation Iraqi Freedom , and Operation New Dawn with chronic ( > 3 months ) and disabling ( Roland Morris Disability Scale score , 7 ) musculoskeletal pain of the cervical or lumbar spine or extremities ( shoulders , knees , and hips ) in the Evaluation of Stepped Care for Chronic Pain ( ESCAPE ) trial from December 20 , 2007 , through June 30 , 2011 .


The 9-month follow-up was completed by April 2012 .


Patients received treatment at a postdeployment clinic and 5 general medicine clinics at a Veterans Affairs medical center .


Step 1 included 12 weeks of analgesic treatment and optimization according to an algorithm coupled with pain self-management strategies ; step 2 , 12 weeks of cognitive behavioral therapy .


All intervention aspects were delivered by nurse care managers .


Pain-related disability ( Roland Morris Disability Scale ) , pain interference ( Brief Pain Inventory ) , and pain severity ( Graded Chronic Pain Scale ) .


The primary analysis included 121 patients receiving the stepped-care intervention and 120 patients receiving usual care .


At 9 months , the mean decrease from baseline in the Roland Morris Disability Scale score was 1.7 ( 95 % CI , -2.6 to -0.9 ) points in the usual care group and 3.7 ( 95 % CI , -4.5 to -2.8 ) points in the intervention group ( between-group difference , -1.9 [ 95 % CI , -3.2 to -0.7 ] points ; P = .002 ) .


The mean decrease from baseline in the Pain Interference subscale score of the Brief Pain Inventory was 0.9 points in the usual care group and 1.7 points in the intervention group ( between-group difference , -0.8 [ 95 % CI , -1.3 to -0.3 ] points ; P = .003 ) .


The Graded Chronic Pain Scale severity score was reduced by 4.5 points in the usual care group and 11.1 points in the intervention group ( between-group difference , -6.6 [ 95 % CI , -10.5 to -2.7 ] points ; P = .001 ) .


A stepped-care intervention that combined analgesics , self-management strategies , and brief cognitive behavioral therapy resulted in statistically significant reductions in pain-related disability , pain interference , and pain severity in veterans with chronic musculoskeletal pain .


clinicaltrials.gov Identifier : NCT00386243 .


Ferric citrate hydrate is a novel iron-based phosphate binder being developed for hyperphosphatemia in patients with CKD .


A phase 3 , multicenter , randomized , double blind , placebo-controlled study investigated the efficacy and safety of ferric citrate hydrate in nondialysis-dependent patients with CKD .


Starting in April of 2011 , 90 CKD patients ( eGFR = 9.215.72 ml/min per 1.73 m ( 2 ) ) with a serum phosphate5 .0 mg/dl were randomized 2:1 to ferric citrate hydrate or placebo for 12 weeks .


The primary end point was change in serum phosphate from baseline to the end of treatment .


Secondary end points included the percentage of patients achieving target serum phosphate levels ( 2.5-4 .5 mg/dl ) and change in fibroblast growth factor-23 at the end of treatment .


The mean change in serum phosphate was -1.29 mg/dl ( 95 % confidence interval , -1.63 to -0.96 mg/dl ) in the ferric citrate hydrate group and 0.06 mg/dl ( 95 % confidence interval , -0.20 to 0.31 mg/dl ) in the placebo group ( P < 0.001 for difference between groups ) .


The percentage of patients achieving target serum phosphate levels was 64.9 % in the ferric citrate hydrate group and 6.9 % in the placebo group ( P < 0.001 ) .


Fibroblast growth factor-23 concentrations were significantly lower in patients treated with ferric citrate hydrate versus placebo ( change from baseline [ median ] , -142.0 versus 67.0 pg/ml ; P < 0.001 ) .


Ferric citrate hydrate significantly increased serum iron , ferritin , and transferrin saturation compared with placebo ( P = 0.001 or P < 0.001 ) .


Five patients discontinued active treatment because of treatment-emergent adverse events with ferric citrate hydrate treatment versus one patient with placebo .


Overall , adverse drug reactions were similar in patients receiving ferric citrate hydrate or placebo , with gastrointestinal disorders occurring in 30.0 % of ferric citrate hydrate patients and 26.7 % of patients receiving placebo .


In patients with nondialysis-dependent CKD , 12-week treatment with ferric citrate hydrate resulted in significant reductions in serum phosphate and fibroblast growth factor-23 while simultaneously increasing serum iron parameters .


Duchenne and Becker muscular dystrophies ( DBMD ) are allelic disorders caused by mutations in dystrophin .


Adults with DBMD develop life-threatening cardiomyopathy .


Inhibition of phosphodiesterase 5 ( PDE5 ) improves cardiac function in mouse models of DBMD .


To determine whether the PDE5-inhibitor sildenafil benefits human dystrophinopathy , we conducted a randomized , double-blind , placebo-controlled trial ( ClinicalTrials.gov , number NCT01168908 ) .


Adults with DBMD and cardiomyopathy ( ejection fraction50 % ) were randomized to receive sildenafil ( 20mg 3 daily ) or placebo for 6 months .


All subjects received an additional 6 months of open-label sildenafil .


The primary endpoint was change in left ventricular end-systolic volume ( LVESV ) on cardiac magnetic resonance imaging .


Secondary cardiac endpoints , skeletal muscle function , and quality of life were also assessed .


An interim analysis ( performed after 15 subjects completed the blinded phase ) revealed that 29 % ( 4 of 14 ) of subjects had a 10 % increase in LVESV after 6 months of sildenafil compared to 13 % ( 1 of 8 ) of subjects receiving placebo .


Subjects with LVESV > 120ml at baseline were more likely to worsen at 12 months regardless of treatment assignment ( p = 0.035 ) .


Due to the higher number of subjects worsening on sildenafil , the data and safety monitoring board recommended early termination of the study .


There were no statistically significant differences in outcome measures between treatment arms .


Due to the small sample size , comparisons between groups must be interpreted with caution .


However , this trial suggests that sildenafil is unlikely to improve cardiac function in adults with DBMD .


The aim of the present exploratory clinical study was to evaluate LD as an add-on therapy for treating nightmares .


Thirty-two subjects having nightmares ( ICD-10 : F51 .5 ) at least twice a week participated .


Subjects were randomly assigned to group : A ) Gestalt therapy group ( = GTG ) , or B ) Gestalt and lucid dreaming group therapy ( = LDG ) .


Each group lasted ten weeks .


Participants kept a sleep/dream diary over the treatment .


Examinations with respect to nightmare frequency and sleep quality ( Pittsburgh Sleep Quality Index ) were carried out at the beginning , after five and ten weeks and at a follow-up three months later .


Concerning nightmare frequency , a significant reduction was found in both groups after the ten-week-study and at the follow-up ( Wilcoxon test : P 0.05 ) .


Significant reduction in dream recall frequency could only be observed in the GTG ( Wilcoxon test : P 0.05 ) .


For subjects having succeeded in learning lucid dreaming , reduction was sooner and higher .


Sleep quality improved for both groups at the follow-up ( P 0.05 , Wilcoxon test ) .


Only the LDG showed significant improvement at the end of therapy ( P 0.05 ) .


Lucid dreaming , in combination with Gestalt therapy , is a potent technique to reduce nightmare frequency and improve the subjective quality of sleep .


In Serbia , there have been no broad campaigns or educational programs focused on adolescents ' sun protection .


The aim of the study was to assess whether an educational program would have impact on changes of attitudes and sun-protective behaviors of high school students .


More specific aim was to examine whether sex and age differences in sun behavior exists .


Educational program was designed to provoke changes in attitudes towards sun protection and sun behavior .


The investigation was carried out in Belgrade , Serbia in two educational cycles , during spring 2007 and 2008 .


Sixteen - and 17-year old high schools students were targeted and assessed before and after the educational intervention by means of self-report questionnaire designed for this study ( about skin types and sun behavior ) .


The students ' attitudes towards sun protection and sun behavior before and after the educational intervention were compared and analyzed by the Pearson 's chi-square test and logistic regression analyses .


In the second educational cycle ( 2008 ) age and gender differences in sun behavior were analyzed .


Overall 3205 students in 2007 , and 2155 students in 2008 year from 11 high schools participated .


A statistically significant behavior change was observed for the use of sunglasses in 2007 -- the number of students using them increased from 41.6 % to 45.6 % ( p < 0.05 ) .


There were no significant changes in other ways of protection i.e. sunscreen use , protective clothes or staying in shade .


Educational program had an impact , but broader activities involving schools , local communities and media are needed for significant changes in sun behavior and attitude .


There are no treatments available to slow or prevent the progression of Parkinson disease , despite its global prevalence and significant health care burden .


The National Institute of Neurological Disorders and Stroke Exploratory Trials in Parkinson Disease program was established to promote discovery of potential therapies .


To determine whether creatine monohydrate was more effective than placebo in slowing long-term clinical decline in participants with Parkinson disease .


The Long-term Study 1 , a multicenter , double-blind , parallel-group , placebo-controlled , 1:1 randomized efficacy trial .


Participants were recruited from 45 investigative sites in the United States and Canada and included 1741 men and women with early ( within 5 years of diagnosis ) and treated ( receiving dopaminergic therapy ) Parkinson disease .


Participants were enrolled from March 2007 to May 2010 and followed up until September 2013 .


Participants were randomized to placebo or creatine ( 10 g/d ) monohydrate for a minimum of 5 years ( maximum follow-up , 8 years ) .


The primary outcome measure was a difference in clinical decline from baseline to 5-year follow-up , compared between the 2 treatment groups using a global statistical test .


Clinical status was defined by 5 outcome measures : Modified Rankin Scale , Symbol Digit Modalities Test , PDQ-39 Summary Index , Schwab and England Activities of Daily Living scale , and ambulatory capacity .


All outcomes were coded such that higher scores indicated worse outcomes and were analyzed by a global statistical test .


Higher summed ranks ( range , 5-4775 ) indicate worse outcomes .


The trial was terminated early for futility based on results of a planned interim analysis of participants enrolled at least 5 years prior to the date of the analysis ( n = 955 ) .


The median follow-up time was 4 years .


Of the 955 participants , the mean of the summed ranks for placebo was 2360 ( 95 % CI , 2249-2470 ) and for creatine was 2414 ( 95 % CI , 2304-2524 ) .


The global statistical test yielded t1865 .8 = -0.75 ( 2-sided P = .45 ) .


There were no detectable differences ( P < .01 to partially adjust for multiple comparisons ) in adverse and serious adverse events by body system .


Among patients with early and treated Parkinson disease , treatment with creatine monohydrate for at least 5 years , compared with placebo did not improve clinical outcomes .


These findings do not support the use of creatine monohydrate in patients with Parkinson disease .


clinicaltrials.gov Identifier : NCT00449865 .


There is a dual need for ( 1 ) innovative theory-based smartphone applications for smoking cessation and ( 2 ) controlled trials to evaluate their efficacy .


Accordingly , this study tested the feasibility , acceptability , preliminary efficacy , and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy ( ACT ) application for smoking cessation vs. an application following US Clinical Practice Guidelines .


Adult participants were recruited nationally into the double-blind randomized controlled pilot trial ( n = 196 ) that compared smartphone-delivered ACT for smoking cessation application ( SmartQuit ) with the National Cancer Institute 's application for smoking cessation ( QuitGuide ) .


We recruited 196 participants in two months .


SmartQuit participants opened their application an average of 37.2 times , as compared to 15.2 times for QuitGuide participants ( p < 0001 ) .


The overall quit rates were 13 % in SmartQuit vs. 8 % in QuitGuide ( OR = 2.7 ; 95 % CI = 0.8-10 .3 ) .


Consistent with ACT 's theory of change , among those scoring low ( below the median ) on acceptance of cravings at baseline ( n = 88 ) , the quit rates were 15 % in SmartQuit vs. 8 % in QuitGuide ( OR = 2.9 ; 95 % CI = 0.6-20 .7 ) .


ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines .


As results were limited by the pilot design ( e.g. , small sample ) , a full-scale efficacy trial is now needed .


The Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) showed that early intervention with cardiac-resynchronization therapy with a defibrillator ( CRT-D ) in patients with an electrocardiographic pattern showing left bundle-branch block was associated with a significant reduction in heart-failure events over a median follow-up of 2.4 years , as compared with defibrillator therapy alone .


We evaluated the effect of CRT-D on long-term survival in the MADIT-CRT population .


Post-trial follow-up over a median period of 5.6 years was assessed among all 1691 surviving patients ( phase 1 ) and subsequently among 854 patients who were enrolled in post-trial registries ( phase 2 ) .


All reported analyses were performed on an intention-to-treat basis .


At 7 years of follow-up after initial enrollment , the cumulative rate of death from any cause among patients with left bundle-branch block was 18 % among patients randomly assigned to CRT-D , as compared with 29 % among those randomly assigned to defibrillator therapy alone ( adjusted hazard ratio in the CRT-D group , 0.59 ; 95 % confidence interval [ CI ] , 0.43 to 0.80 ; P < 0.001 ) .


The long-term survival benefit of CRT-D in patients with left bundle-branch block did not differ significantly according to sex , cause of cardiomyopathy , or QRS duration .


In contrast , CRT-D was not associated with any clinical benefit and possibly with harm in patients without left bundle-branch block ( adjusted hazard ratio for death from any cause , 1.57 ; 95 % CI , 1.03 to 2.39 ; P = 0.04 ; P < 0.001 for interaction of treatment with QRS morphologic findings ) .


Our findings indicate that in patients with mild heart-failure symptoms , left ventricular dysfunction , and left bundle-branch block , early intervention with CRT-D was associated with a significant long-term survival benefit .


( Funded by Boston Scientific ; ClinicalTrials.gov numbers , NCT00180271 , NCT01294449 , and NCT02060110 . )


Mass drug administration ( MDA ) is part of the SAFE strategy for trachoma elimination .


This study examined the effect of three annual MDAs on prevalence of trachoma among 13 longitudinal cohorts of Tanzanian children .


Children younger than 10 years were assigned to cohorts based on age at baseline and followed annually for 3 years , with newborns assigned to new cohorts over time .


Annual MDA consisted of topical tetracycline for children younger than 6 months and oral azithromycin for those 6 months and older .


Follicular trachoma ( TF ) and Chlamydia trachomatis infection status were assessed annually before the next MDA .


Prevalence and risk factors for TF and infection at each age were compared across cohorts .


At each survey , most age groups and cohorts had MDA coverage of more than 80 % and showed decreased TF prevalence after every MDA .


One cohort had consistently lower coverage , higher-than-expected TF and infection at ages 6 and 7 , and elevated risk of TF at age 7 relative to the preceding cohort in spite of receiving one additional MDA ( odds ratio 2.3 , 95 % confidence interval 1.0-5 .2 ) .


Cohorts aged 1 or older at baseline generally showed reductions in TF and infection after each MDA , whereas younger cohorts showed decreased infection but increased TF over time .


Successive cohorts of never-treated children younger than 1 year showed sequential TF and infection reductions with each MDA ( P < 0.001 ) .


Multiple MDAs significantly reduce trachoma prevalence and appear to increasingly protect children born into these communities .


The youngest children show declining/stable rates of infection but increasing rates of trachoma , which may reflect longer duration of clinical signs .


Tamoxifen , a synthetic nonsteroidal anti-estrogen known to modulate the production of transforming growth factor-beta ( TGF - ) , has demonstrated effectiveness on fibroblast activity in vitro and in vivo .


The main purpose of this study was to investigate the effect of tamoxifen on the outcome of surgery for Dupuytren contractures in patients with a strong predisposition toward fibrosis .


We used a prospective , randomized , double-blind study protocol ( conforming to the CONSORT standards ) to investigate the influence of tamoxifen compared with placebo on the total passive extension deficit in the finger and patient satisfaction after subtotal fasciectomy in thirty patients with a strong predisposition toward fibrosis ( grade , > 4 according to the Abe scale ) .


High-dosage tamoxifen ( 80 mg/day ) was administered from six weeks prior until twelve weeks after surgery , and patients were monitored for two years .


Three months after surgery , patients in the tamoxifen group had a smaller total passive extension deficit and higher satisfaction compared with the placebo group .


This positive effect was lost over the two years following cessation of the medication .


This study demonstrated that the short-term outcome of Dupuytren disease treatment could be influenced by use of tamoxifen as a neoadjuvant from six weeks prior to three months after subtotal fasciectomy in patients with a strong predisposition toward fibrosis .


However , the beneficial effect disappeared within two years after surgery , with worsening of the contractures after the medication was discontinued .


Thus , tamoxifen may have a short-term effect on the outcome of surgery for Dupuytren disease .


Cardiopulmonary bypass initiates a systemic inflammatory response syndrome that is associated with postoperative morbidity and mortality .


Steroids suppress inflammatory responses and might improve outcomes in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass .


We aimed to assess the effects of steroids in patients at high risk of morbidity and mortality undergoing cardiopulmonary bypass .


The Steroids In caRdiac Surgery ( SIRS ) study is a double-blind , randomised , controlled trial .


We used a central computerised phone or interactive web system to randomly assign ( 1:1 ) patients at high risk of morbidity and mortality from 80 hospital or cardiac surgery centres in 18 countries undergoing cardiac surgery with the use of cardiopulmonary bypass to receive either methylprednisolone ( 250 mg at anaesthetic induction and 250 mg at initiation of cardiopulmonary bypass ) or placebo .


Patients were assigned with block randomisation with random block sizes of 2 , 4 , or 6 and stratified by centre .


Patients aged 18 years or older were eligible if they had a European System for Cardiac Operative Risk Evaluation of at least 6 .


Patients were excluded if they were taking or expected to receive systemic steroids in the immediate postoperative period or had a history of bacterial or fungal infection in the preceding 30 days .


Patients , caregivers , and those assessing outcomes were masked to allocation .


The primary outcomes were 30-day mortality and a composite of death and major morbidity ( ie , myocardial injury , stroke , renal failure , or respiratory failure ) within 30 days , both analysed by intention to treat .


Safety outcomes were also analysed by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT00427388 .


Patients were recruited between June 21 , 2007 , and Dec 19 , 2013 .


Complete 30-day data was available for all 7507 patients randomly assigned to methylprednisolone ( n = 3755 ) and to placebo ( n = 3752 ) .


Methylprednisolone , compared with placebo , did not reduce the risk of death at 30 days ( 154 [ 4 % ] vs 177 [ 5 % ] patients ; relative risk [ RR ] 087 , 95 % CI 070-107 , p = 019 ) or the risk of death or major morbidity ( 909 [ 24 % ] vs 885 [ 24 % ] ; RR 103 , 95 % CI 095-111 , p = 052 ) .


The most common safety outcomes in the methylprednisolone and placebo group were infection ( 465 [ 12 % ] vs 493 [ 13 % ] ) , surgical site infection ( 151 [ 4 % ] vs 151 [ 4 % ] ) , and delirium ( 295 [ 8 % ] vs 289 [ 8 % ] ) .


Methylprednisolone did not have a significant effect on mortality or major morbidity after cardiac surgery with cardiopulmonary bypass .


The SIRS trial does not support the routine use of methylprednisolone for patients undergoing cardiopulmonary bypass .


Canadian Institutes of Health Research .


Previous studies have reported the cardioprotective effect of dexmedetomidine and lidocaine .


We compared the effect of lidocaine and dexmedetomidine infusion during off-pump coronary artery bypass graft ( OPCAB ) .


153 patients undergoing OPCAB were enrolled .


The lidocaine group ( n = 36 , Group LIDO ) received an infusion of lidocaine 2 mg/kg/h after bolus 1.5 mg/kg ; the dexmedetomidine group ( n = 40 , Group DEX ) received dexmedetomidine 0.3-0 .7 g/kg/h ; the combined group ( n = 39 , Group Combined ) received infusion of both drugs ; and the control group ( n = 38 ) received nothing .


We measured serum creatinine kinase-myocardial band ( CK-MB ) and cardiac troponin I ( cTnI ) concentration before and immediately after the surgery , postoperative day ( POD ) # 1 and # 2 .


The complication rate and clinical outcomes were compared .


The concentration of cTnI was significantly lower in the Group LIDO and Group Combined than the control group on POD # 2 .


The concentration of CK-MB was significantly lower in the Group LIDO and Group Combined compared to the control group on POD # 1 and # 2 [ CK-MB on POD # 1 : 7.67 ( 5.78-11 .92 ) vs. 7.18 ( 5.01-11 .72 ) vs. 13.19 ( 6.85-23 .87 ) in the Group LIDO , combined and control , respectively , Group LIDO vs. control : p = 0.003 , Group Combined vs. control : p = 0.015 ] .


The AUC of CK-MB was significantly lower in the Group LIDO and Group Combined than the control group .


However , clinical variables including complication rate , ICU stay and one-year mortality were not different .


Lidocaine infused at 2 mg/kg/h , but not dexmedetomidine infused at 0.3-0 .7 g/kg/h reduced postoperative myocardial injury marker levels compared with the control group .


However , no other clinical benefits were observed .


To compare estimates by bioimpedance spectroscopy analysis ( BIS ) of extracellular water ( ECW ) , fat mass ( FM ) , and fat-free mass ( FFM ) against standard techniques of bromide dilution and dual energy X-ray absorptiometry ( DXA ) during intervention that causes significant changes in water compartments and body composition .


Body composition analysis using BIS , bromide dilution , and DXA was performed in 71 healthy recreational athletes ( 43 men , 28 women ; aged 18-40 years ; BMI 24 0.4 kg/m ( 2 ) ) who participated in a double-blinded , randomized , placebo-controlled study of GH and testosterone treatment .


The comparison of BIS with bromide dilution and DXA was analyzed using linear regression and the Bland-Altman method .


At baseline , there was a significant correlation between BIS and bromide dilution-derived estimates for ECW , and DXA for FM and FFM ( P < 0.001 ) .


ECW by BIS was 3.5 8.1 % lower compared with bromide dilution , while FM was 22.4 26.8 % lower and FFM 13.7 7.5 % higher compared with DXA ( P < 0.01 ) .


During treatment , the change in ECW was similar between BIS and bromide dilution , whereas BIS gave a significantly greater reduction in FM ( 19.4 44.8 % ) and a greater increase in FFM ( 5.6 3.0 % ) compared with DXA ( P < 0.01 ) .


Significant differences in body composition estimates between the BIS and DXA were observed only in men , particularly during the treatment that caused greatest change in water compartments and body composition .


In healthy adults , bioimpedance spectroscopy is an acceptable tool for measuring ECW ; however , BIS overestimates FFM and substantially underestimates FM compared with DXA .


Long-acting injectable antipsychotics are used to reduce medication nonadherence and relapse in schizophrenia-spectrum disorders .


The relative effectiveness of long-acting injectable versions of second-generation and older antipsychotics has not been assessed .


To compare the effectiveness of the second-generation long-acting injectable antipsychotic paliperidone palmitate with the older long-acting injectable antipsychotic haloperidol decanoate .


Multisite , double-blind , randomized clinical trial conducted from March 2011 to July 2013 at 22 US clinical research sites .


Randomized patients ( n = 311 ) were adults diagnosed with schizophrenia or schizoaffective disorder who were clinically assessed to be at risk of relapse and likely to benefit from a long-acting injectable antipsychotic .


Intramuscular injections of haloperidol decanoate 25 to 200 mg or paliperidone palmitate 39 to 234 mg every month for as long as 24 months .


Efficacy failure , defined as a psychiatric hospitalization , a need for crisis stabilization , a substantial increase in frequency of outpatient visits , a clinician 's decision that oral antipsychotic could not be discontinued within 8 weeks after starting the long-acting injectable antipsychotics , or a clinician 's decision to discontinue the assigned long-acting injectable due to inadequate therapeutic benefit .


Key secondary outcomes were common adverse effects of antipsychotic medications .


There was no statistically significant difference in the rate of efficacy failure for paliperidone palmitate compared with haloperidol decanoate ( adjusted hazard ratio , 0.98 ; 95 % CI , 0.65-1 .47 ) .


The number of participants who experienced efficacy failure was 49 ( 33.8 % ) in the paliperidone palmitate group and 47 ( 32.4 % ) in the haloperidol decanoate group .


On average , participants in the paliperidone palmitate group gained weight and those in the haloperidol decanoate group lost weight ; after 6 months , the least-squares mean weight change for those taking paliperidone palmitate was increased by 2.17 kg ( 95 % CI , 1.25-3 .09 ) and was decreased for those taking haloperidol decanoate ( -0.96 kg ; 95 % CI , -1.88 to -0.04 ) .


Patients taking paliperidone palmitate had significantly higher maximum mean levels of serum prolactin ( men , 34.56 g/L [ 95 % CI , 29.75-39 .37 ] vs 15.41 g/L [ 95 % CI , 10.73-20 .08 ] ; P < .001 , and for women , 75.19 [ 95 % CI , 63.03-87 .36 ] vs 26.84 [ 95 % CI , 13.29-40 .40 ] ; P < .001 ) .


Patients taking haloperidol decanoate had significantly larger increases in global ratings of akathisia ( 0.73 [ 95 % CI , 0.59-0 .87 ] vs 0.45 [ 95 % CI , 0.31-0 .59 ] ; P = .006 ) .


In adults with schizophrenia or schizoaffective disorder , use of paliperidone palmitate vs haloperidol decanoate did not result in a statistically significant difference in efficacy failure , but was associated with more weight gain and greater increases in serum prolactin , whereas haloperidol decanoate was associated with more akathisia .


However , the CIs do not rule out the possibility of a clinically meaningful advantage with paliperidone palmitate .


clinicaltrials.gov Identifier : NCT01136772 .


To investigate whether short-term systemic effects of wood smoke occurred in atopic subjects after experimental wood smoke exposures .


A double-blind climate chamber study was conducted on 20 healthy atopic subjects with exposures to filtered air and wood smoke .


Pneumoproteins , coagulation and adhesion factors , and cytokines were measured .


Heart rate was monitored with pulse monitors .


Data were analyzed with mixed models .


Few differences in the outcomes were observed .


Plasma tissue factor remained elevated during filtered air exposure ( P = 0.002 ) .


P-selectin declined independent of exposure ( P = 0.0006 ) .


Interleukin-6 increased after filtered air ( P = 0.03 ) .


The study confirmed previous observations among nonatopics of limited changes after a 3-hour wood smoke exposure .


It has been suggested that weight reduction decreases the frequency of urinary incontinence ( UI ) episodes .


However , it is not known if this improvement is associated with anatomical changes in the pelvis .


The aim of this study was to investigate the effects of weight loss on UI episodes and pelvic floor anatomy .


Three hundred seventy-eight overweight/obese women were randomly allocated either to behavioral weight loss or to structured education programs .


The patients were evaluated by voiding diary , Pelvic Floor Distress Inventory ( PFDI ) , and Pelvic Organ Prolapse Quantification ( POP-Q ) system at baseline and after 6months .


The women in the intervention group had a mean weight loss of 9.4 % , whereas the weight in the control group remained almost the same ( P < 0.001 ) .


While there were no change in stress and urge incontinence episodes in the control group , the mean number of stress incontinence episodes per 3-day diary dropped from 7.96 episodes to 3.11 , and the mean number of urge incontinence episodes per 3-day diary dropped from 2.85 episodes to 1.08 in the study group ( P < 0.05 ) .


Regarding the POP-Q system , only genital hiatus , perineal body , and Ap measurements were significantly lower in the weight loss group than in the control group after 6months .


Weight reduction provides improvement in episodes of UI , decreases the incidence of drops of urine leakage , and increases quality of life related to pelvic floor symptoms .


However , there are little to no changes in the parameters of the POP-Q system with weight reduction .


Single-day , high-dose systemic antiviral drugs are effective in the treatment of labial herpes ( herpes labialis [ HL ] ) .


Aciclovir Lauriad mucoadhesive buccal tablet ( ABT ) is an innovative drug delivery system providing high and prolonged exposure to aciclovir in the oral cavity , supporting its evaluation as a single low dose in HL .


In this multicenter double-blind placebo-controlled patient-initiated trial , 775 patients with recurrent HL were randomly assigned to either a single application of ABT 50 mg or a matching placebo as soon as prodromal symptoms occurred .


The primary endpoint was the time to healing ( TTH ) of primary vesicular lesion ( modified intention-to-treat population ) .


Other endpoints included incidence of blocked episodes , duration of herpes episodes , and incidence and time to next recurrence evaluated during a 9-month follow-up period ( intention-to-treat population ) .


With ABT 50 mg , median TTH of primary vesicular lesion was reduced ( 7 days vs 7.3 days , P = .015 ) , the incidence of blocked herpes episodes was increased by 24.2 % ( 34.9 % vs 28.1 % ; P = .042 ) , and the median duration of herpes episodes was reduced ( 5.6 days vs 6.4 days , P = .003 ) .


During the 9-month follow-up period , recurrence of herpes lesions was less frequent ( 64.2 % vs 73.6 % ; P = .027 ) and delayed ( 205 days vs 165 days , P = .041 ) in the ABT 50 mg .


Both treatments were safe .


A single application of ABT improves all endpoints of HL and might modify its clinical course in decreasing the incidence and delaying the onset of the next recurrence .


There is a need to evaluate and implement cost-effective strategies to improve adherence to treatments in coronary heart disease .


There are no studies from low - to middle income countries ( LMICs ) evaluating trained community health worker ( CHW ) - based interventions for the secondary prevention of coronary heart disease .


We designed a hospital-based , open randomized trial of CHW-based interventions versus standard care .


Patients after an acute coronary syndrome ( ACS ) were randomized to an intervention group ( a CHW-based intervention package , comprising education tools to enhance self-care and adherence , and regular follow-up by the CHW ) or to standard care for 12 months during which study outcomes were recorded .


The CHWs were trained over a period of 6 months .


The primary outcome measure was medication adherence .


The secondary outcomes were differences in adherence to lifestyle modification , physiological parameters ( blood pressure [ BP ] , body weight , body mass index [ BMI ] , heart rate , lipids ) , and major adverse cardiovascular events .


We recruited 806 patients stabilized after an ACS from 14 hospitals in 13 Indian cities .


The mean age was 56.4 ( 11.32 ) years , and 17.2 % were females .


A high prevalence of risk factors such as hypertension ( 43.4 % ) , diabetes ( 31.9 % ) , tobacco consumption ( 35.4 % ) , and inadequate physical activity ( 70.5 % ) was documented .


A little over half had ST-elevation myocardial infarction ( 53.7 % ) , and 46.3 % had non-ST-elevation myocardial infarction or unstable angina .


The CHW interventions and training for SPREAD have been developed and adapted for local use .


The results and experience of this study will be important to counter the burden of cardiovascular diseases in low - to middle income countries .


We assessed safety and efficacy of two selective 11-HSD1 inhibitors ( RO5093151/RO -151 and RO5027383/RO -838 ) in this randomized , controlled study in metformin-treated patients with type 2 diabetes .


Patients either received placebo ( N = 21 ) , RO-151 BID 5 mg ( N = 24 ) or 200 mg ( N = 20 ) or RO-838 QD 50 mg ( N = 21 ) or 200 mg ( N = 24 ) for 28 days .


Metabolic assessments comprising of nine-point plasma glucose profiles , oral glucose tolerance tests and determination of metabolic biomarkers including insulin , C-peptide , glucagon , HbA1c and lipids were done at baseline and end of treatment .


Despite the short treatment duration , both RO-151 and RO-838 showed trends for improved HbA1c and consistent reductions in body weight ( -0.86 to -1.67 kg ) exceeding those observed with placebo ( -0.28 kg , p = 0.019 for 200 mg RO-151 vs. placebo ) .


Insulin sensitivity parameters ( e.g. HOMA-IR and Matsuda-Index ) improved non-significantly with 200 mg RO-151 .


Lipid parameters did not consistently improve with either compound , but RO-838 led to non-significant increases in triglycerides and VLDL-cholesterol versus placebo .


Both compounds were well tolerated and showed inhibitory effects on 11-HSD1 activity based on urinary corticosteroid excretion .


As reported for other 11-HSD1-inhibitors increased concentrations of ACTH and adrenal androgen precursors were found with RO-151 , but not with RO-838 .


Slight metabolic improvements were seen , in particular with RO-151 high dose , however , the observed changes often did not reach statistical significance and were not clearly dose dependent .


Studies of longer duration are needed to further investigate potential benefits and risks of these compounds .


To evaluate the effect of wearing a dorsiflexion assist orthosis ( DAO ) on walking distance , physiological cost , fatigue , and strength and balance measures after a modified 6-minute walk test ( 6MWT ) in people with multiple sclerosis ( MS ) .


Randomized crossover trial .


Hospital Movement Laboratory .


People with moderate MS and Expanded Disability Status Scale score of 3.70.7 ( N = 34 ; 26 women ) .


Modified 6MWT with and without a DAO worn on the weaker leg .


Distance walked , perceived fatigue , and the physiological cost of walking were compared between walking conditions .


Pre - and postwalk changes in knee extensor and ankle dorsiflexor isometric strength and standing postural sway with eyes open and closed were compared between walking conditions .


There were no differences in distance walked or perceived fatigue between the 2 walking conditions .


However , there was a reduced physiological cost of walking ( P < .05 ) , a smaller reduction in knee extensor strength ( P < .05 ) , and a smaller increase in standing postural sway with eyes open ( P < .01 ) after walking while wearing the DAO compared with walking without wearing the DAO .


Despite not increasing walking distance or reducing perceived fatigue , the DAO reduced the physiological cost of walking and maintained knee strength and standing balance , which may have important implications for physical rehabilitation in people with MS. Further trials are required to determine whether the beneficial effects of wearing a DAO found here are maintained for longer periods .


Menu labels displaying food energy in physical activity calorie equivalents ( PACE ) is a possible strategy to encourage ordering meals with fewer calories and promoting physical activity .


Potential effects of such labeling for children have never been examined .


We conducted a national survey of 1000 parents randomized to 1 of 4 fast food menus : no labels , calories only , calories plus minutes , or calories plus miles needed to walk to burn the calories .


Respondents were asked to imagine they were in a fast food restaurant and place an order for their child .


At the survey 's conclusion , all respondents were shown a calorie-only label and both PACE labels and asked to rate the likelihood each label would influence them to encourage their child to exercise .


We excluded respondents whose meals totaled 0 calories or > 4000 calories , leaving 823 parents in the analysis .


The mean age of the child for whom the meal was `` ordered '' was 9.5 years .


Parents whose menus displayed no label ordered an average of 1294 calories , whereas those shown calories only , calories plus minutes , or calories plus miles ordered 1066 , 1060 , and 1099 calories , respectively ( P = .0001 ) .


Only 20 % of parents reported that calories-only labeling would be `` very likely '' to prompt them to encourage their children to exercise versus 38 % for calories plus minutes ( P < .0001 ) and 37 % for calories plus miles ( P < .0001 ) .


PACE labeling may influence parents ' decisions on what fast food items to order for their children and encourage them to get their children to exercise .


Recurrent laryngeal nerve palsy ( RLNP ) and hypoparathyroidism are complications of thyroid surgery .


The convalescence can depend on several factors ( ie , pain , fatigue , nausea , and vomiting ) .


Supplemental oxygen improves inflammatory and immune function and decreases nausea and vomiting after surgical procedures .


We have investigated whether supplemental perioperative oxygen administration could improve surgical outcomes in patients undergoing thyroid surgery .


Three hundred and sixty patients were randomized to an oxygen/air mixture with a fraction of inspired oxygen ( FiO2 ) of 30 % ( n = 179 ) or 80 % ( n = 181 ) .


Administration was commenced after induction of anesthesia and maintained for 6 hours after surgery .


The primary end points were temporary or permanent RLNP and transient or definitive hypoparathyroidism .


Pain and fatigue scores , nausea , and the number of vomiting episodes were also registered .


Preoperatively and at several times during the first 24 postoperative hours , we measured C-reactive protein , interleukin ( IL ) -6 , and IL1 levels .


In the 80 % FiO2 group , the rate of temporary RLNP ( 4.4 % ) was significantly lower compared with the 30 % FiO2 group ( 9.4 % ) ( p = 0.040 ) .


In addition , postoperative transient biochemical hypoparathyroidism occurred more frequently in the 30 % FiO2 group ( 48.5 % ) than in the 80 % FiO2 group ( 16.3 % ) ( p = 0.046 ) .


Supplemental 80 % FiO2 significantly reduced postoperative levels of C-reactive protein ( p < 0.01 ) , IL6 and IL1 ( p < 0.05 ) , fatigue ( p < 0.01 ) , and overall pain during the first 24 postoperative hours ( p < 0.01 ) .


Supplemental 80 % FiO2 also reduced nausea and vomiting on the day of operation ( p = 0.058 ) .


Supplemental 80 % FiO2 reduced postoperative temporary RLNP and hypoparathyroidism rates and reduced pain , fatigue , nausea , and vomiting after thyroid surgery .


Treatment of patients with multimorbidity is challenging .


A rational reduction of long-term drugs can lead to decreased mortality , less acute hospital treatment , and a reduction of costs .


Simplification of drug treatment schemes is also related to higher levels of patient satisfaction and adherence .


The POLITE-RCT trial will test the effectiveness of an intervention aiming at reducing the number of prescribed long-term drugs among multimorbid and chronically ill patients .


The intervention focuses on the interface between primary and secondary health care and includes a pharmacist-based , patient-centered medication review prior to the patient 's discharge from hospital .


The POLITE-RCT trial is a cluster randomized controlled trial .


Two major secondary health care providers of Mecklenburg-Western Pomerania , Germany , take part in the study .


Clusters are wards of both medical centers .


All wards where patients with chronic diseases and multimorbidity are regularly treated will be included .


Patients aged 65 + years who take five or more prescribed long-term drugs and who are likely to spend at least 5 days in the participating hospitals will be recruited and included consecutively .


Cluster-randomization takes place after a six-month baseline data collection period .


Patients of the control group receive care as usual .


The independent two main primary outcomes are ( 1 ) health-related quality of life ( EQ-5D ) and ( 2 ) the difference in the number of prescribed long-term pharmaceutical agents between intervention and control group .


The secondary outcomes are appropriateness of prescribed medication ( PRISCUS list , Beers Criteria , MAI ) , patient satisfaction ( TSQM ) , patient empowerment ( PEF-FB-9 ) , patient autonomy ( IADL ) , falls , re-hospitalization , and death .


The points of measurement are at admission to ( T0 ) and discharge from hospital ( T1 ) as well as 6 and 12 months after discharge from the hospital ( T2 and T3 ) .


In 42 wards , 1,626 patients will be recruited .


In case of positive evaluation , the proposed study will provide evidence for a sustainable reduction of polypharmacy by enhancing patient-centeredness and patient autonomy .


Current Controlled Trials ISRCTN42003273 .


AST1306 is an orally active irreversible small molecule inhibitor of EGFR ( erbB1 ) , HER2 ( erbB2 ) and HER4 ( erbB4 ) signaling .


This is a phase I , open-label , dose-escalation study to evaluate the safety and tolerability , pharmacokinetics ( PK ) , and preliminary anti-tumor effects of oral AST1306 .


In addition the effects of food on PK was tested .


A modified Fibonacci 3 plus 3 dose-escalation design was employed to determine the dose-limiting toxicity ( DLT ) and recommended phase II dose ( RP2D ) in patients with advanced solid tumors .


The following dose levels were investigated : once daily ( QD ) at two dose levels ( 400-and 800 mg ) , twice daily ( BID ) in five dose levels ( 600 - , 800 - , 1000 - , 1200 - and 1500 mg ) , and three times daily ( TID ) in three dose levels ( 800 - , 1000 - and 1200 mg ) .


In the PK and extension study , at least eight patients per dose cohort in three dose levels ( maximum tolerated dose [ MTD ] , one or two doses level lower than the MTD ) were enrolled to evaluate the PK profiles .


Seventy-one patients were enrolled , with breast ( n = 22 ) and lung cancers ( n = 14 ) being the most common primary cancers .


The most frequent drug-related adverse events were grade 1 to 3 diarrhea and rash , grade 1 to 2 fatigue .


During dose escalation , the key DLT was grade 3 diarrhea observed in 5 patients at 1000 mg BID ( n = 1 ) , 1500 mg BID ( n = 1 ) , 800 mg TID ( n = 1 ) and 1200 mg TID ( n = 2 ) .


AST1306 was rapidly absorbed and had moderate to high clearance .


PK concentration parameters increased with dose over the range evaluated , with no evidence of accumulation over time .


Under fed conditions , the mean T ( max ) was prolonged , C ( max ) was increased , and AUC ( 0 - ) was raised .


Of the 55 evaluable patients , 7 patients experienced partial responses , including 5 with breast cancer , 1 with lung cancer , and 1 with gastric cancer .


The best response with stable disease for6 months was achieved in 7 patients .


Based on the DLT and PK profile , the RP2D was defined as 1000 mg TID with evidence of preliminary anti-tumor activity .


Further studies are recommended .


This study aimed to assess the efficacy and safety of flibanserin , a serotonin receptor 1A agonist/serotonin receptor 2A antagonist , in postmenopausal women with hypoactive sexual desire disorder ( HSDD ) .


Naturally postmenopausal women with HSDD received flibanserin 100 mg once daily at bedtime ( n = 468 ) or placebo ( n = 481 ) for 24 weeks .


Co-primary endpoints were changes from baseline to week 24 in the number of satisfying sexual events ( SSEs ) across 28 days and in the Female Sexual Function Index ( FSFI ) desire domain score .


Secondary endpoints included change from baseline in Female Sexual Distress Scale-Revised ( FSDS-R ) Item 13 score ( which assesses distress due to low sexual desire ) , FSDS-R total score , and FSFI total score .


The Patient Benefit Evaluation was asked on treatment discontinuation .


There were significant improvements with flibanserin versus placebo in the mean ( SE ) changes in the number of SSEs ( 1.0 [ 0.1 ] vs 0.6 [ 0.1 ] ) , FSFI desire domain score ( 0.7 [ 0.1 ] vs 0.4 [ 0.1 ] ) , FSDS-R Item 13 score ( -0.8 [ 0.1 ] vs -0.6 [ 0.1 ] ) , FSDS-R total score ( -8.3 [ 0.6 ] vs -6.3 [ 0.6 ] ) , and FSFI total score ( 4.2 [ 0.4 ] vs 2.7 [ 0.4 ] ; all P < 0.01 ) .


More women on flibanserin ( 37.6 % ) than women on placebo ( 28.0 % ) reported experiencing meaningful benefits from the study medication on treatment discontinuation .


The most frequent adverse events associated with flibanserin were dizziness , somnolence , nausea , and headache .


In naturally postmenopausal women with HSDD , flibanserin , compared with placebo , has been associated with improvement in sexual desire , improvement in the number of SSEs , and reduced distress associated with low sexual desire , and is well tolerated .


Gemigliptin is a selective DPP4 inhibitor used to treat type 2 diabetes .


The objective of this study was to evaluate the pharmacokinetics ( PKs ) of gemigliptin , rosuvastatin , and irbesartan monotherapies and combination therapies .


Randomized , open-label , three-treatment , six-sequence , three-period , crossover studies were performed on healthy male volunteers .


The three treatments were : 50mg gemigliptin alone ; 20mg rosuvastatin ( part A ) or 300mg irbesartan alone ( part B ) ; and rosuvastatin or irbesartan with concomitant gemigliptin .


Each drug was administered as part of once daily , 7 day , repeated dosing regimens with a 14 day washout period .


NCT01823133 ( part A ) and NCT01825850 ( part B ) .


The primary PK parameters - Cmax and AUC - were compared to the geometric mean ratios ( GMRs ) and 90 % confidence intervals ( 90 % CIs ) that were determined for the combination therapies and monotherapies .


A total of 60 participants were administered the study drugs , and 52 participants ( 27 participants in part A ; 25 participants in part B ) were analyzed as part of the PK dataset .


In part A , the GMRs ( gemigliptin + rosuvastatin/gemigliptin ) of the Cmax and AUC values of gemigliptin were 0.955 ( 90 % CI = 0.874-1 .044 ) and 1.023 ( 90 % CI = 0.991-1 .057 ) , and those of rosuvastatin were 1.012 ( 90 % CI = 0.946-1 .084 ) and 1.086 ( 90 % CI = 1.032-1 .142 ) , respectively .


In part B , the GMRs of the Cmax and AUC values of gemigliptin were 1.046 ( 90 % CI = 0.964-1 .134 ) and 1.035 ( 90 % CI = 1.005-1 .065 ) , and those of irbesartan were 0.966 ( 90 % CI = 0.897-1 .040 ) and 1.050 ( 90 % CI = 0.993-1 .111 ) , respectively .


The limitations of this study include its relatively short treatment period and small sample size , as only healthy participants were included .


Gemigliptin does not affect the PK properties of rosuvastatin or irbesartan ; also , rosuvastatin and irbesartan do not affect the PKs of gemigliptin .


To evaluate the effects of continuous paravertebral nerve block after nephrectomy .


60 cases receiving simple nephrectomy , American Society of Anesthesiologists ( ASA ) grading status I or II , aged from 30 to 65 years , weighing from 45 to 80 kg , male or female , were randomly divided into 2 groups : control group ( CEA group ) and continuous paravertebral nerve block group ( PVB group ) , 30 patients in each one .


Both groups were performed with 0.2 % ropivacaine 250 ml in continuous infusion , assisted with intravenous morphine patient-controlled analgesia .


The blood gas was examined in 6 , 12 , 24 and 48 h postoperatively , and the VAS scores of quiet state and motion state were assessed.In 48 h postoperation , the total amount of morphine was calculated and the complications cases were recorded .


Compared with the CEA group , PaO2 in PVB group increased and PaCO2 declined significantly .


There was no difference of VAS score under quiet state , but under the motion state the VAS scores declined significantly , the total amount of morphine reduced [ ( 5.2 1.2 ) vs ( 13.9 1.6 ) mg ) ] , the cases of nausea , vomiting , pruritus , orthostatic hypotension decreased and the postoperative first anal exhaust time interval shortened ( P < 0.05 ) .


Compared with CEA , postoperative administration of PVB for open nephrectomy results in lowering morphine dose as well as side effect related with the use of morphine .


To compare the image quality , evaluability , diagnostic accuracy , and radiation exposure of high-spatial-resolution ( HR , 0.23-mm ) computed tomographic ( CT ) coronary angiography with standard spatial resolution ( SR , 0.625-mm ) 64-section imaging in patients at high risk for coronary artery disease ( CAD ) by using invasive coronary angiography ( ICA ) as the reference method .


Written informed consent was obtained from all patients , and the study protocol was approved by the institutional ethical committee .


Patients at high risk for CAD ( n = 184 ) who were scheduled for ICA were randomly assigned for study with SR ( n = 91 ) or HR ( n = 93 ) coronary CT angiography before they underwent ICA .


To compare the two groups , the Student t test or Wilcoxon test were used to evaluate differences in continuous variables .


The ( 2 ) test or Fisher exact test were used , as appropriate , for categorical data .


The McNemar test was used to compare the diagnostic performance of coronary CT angiography versus that of ICA in each group .


HR coronary CT angiography showed a higher image quality score ( 3.7 vs 3.4 , P < .001 ) and evaluability ( 97 % vs 92 % , P < .002 ) .


In a segment-based analysis , HR coronary CT angiography showed a higher specificity , positive predictive value , and accuracy in comparison with SR coronary CT angiography ( 98 % , 91 % , and 99 % vs 95 % , 80 % , and 95 % , respectively ; P < .001 ) .


Moreover , HR coronary CT angiography showed a better agreement with ICA for calcified plaques compared with SR coronary CT angiography and ICA ( 83 % vs 53 % , P < .001 ) .


In a patient-based analysis , HR coronary CT angiography showed higher specificity and accuracy compared with SR coronary CT angiography ( 91 % and 98 % vs 46 % and 92 % , respectively ; P < .01 ) .


No differences in radiation exposure were found between the two groups .


Improved evaluability and accuracy were seen with HR compared with SR coronary CT angiography of calcified coronary artery lesions , suggesting a potential use for this technology in patients at high risk for CAD .


Live animal studies using an inoculation model of breast cancer indicate that anaesthetic drugs and techniques differentially affect cancer metastasis , inversely related to Natural Killer ( NK ) cell and T lymphocyte levels .


Clinical histological studies demonstrate that the distribution of these immune cells and macrophages in intra-tumoral cancer tissue can predict prognosis and response to therapy .


No study has evaluated whether the anaesthetic technique influences human breast cancer immune cell infiltration .


Excised breast cancer specimens from patients previously enrolled in an ongoing , prospective , randomised trial ( NCT00418457 ) investigating the effect of anaesthetic technique on long-term breast cancer outcome were immunohistochemically stained to enable a colour deconvolution technique to summate marked immune cell infiltration : CD56 ( NK cells ) , CD4 ( T helper cells ) , CD8 ( T suppressor cells ) and CD68 ( macrophages ) .


Patients were randomised to receive either a propofol-paravertebral anaesthetic with continuing analgesia ( PPA , n = 12 ) or a balanced general anaesthesia with opioid analgesia ( GA , n = 16 ) for 24 h postoperatively .


Investigators were masked to group allocation .


Normalised positive intensity values , ( median ( interquartile range ( IQR ) ) , for CD56 were lower in GA121 ( 116-134 ) versus 136 ( 132-142 ) , p = 0.015 .


CD4 was also lower in GA10 .9 ( 5.5-27 .8 ) versus PPA 19.7 ( 14.4-83 .5 ) , p = 0.03 but CD8 5.5 ( 4.0-9 .75 ) versus 13.0 ( 5.0-14 .5 ) respectively , p = 0.24 and CD 68 infiltration 5.8 ( 3.25-8 .75 ) versus 8.0 ( 3.0-8 .75 ) , p = 0.74 were not significantly different .


PPA induces increased levels of NK and T helper cell infiltration into breast cancer tissue compared with GA but not T suppressor cells or macro phages .


This is consistent with the hypothesis that the anaesthetic technique may affect perioperative immune function conducive to resisting breast cancer recurrence and metastasis .


Civilian posttraumatic stress disorder ( PTSD ) and combat PTSD are major public health concerns .


Although a number of psychosocial risk factors have been identified related to PTSD risk , there are no accepted , robust biological predictors that identify who will develop PTSD or who will respond to early intervention following trauma .


We wished to examine whether genetic risk for PTSD can be mitigated with an early intervention .


65 emergency department patients recruited in 2009-2010 at Grady Memorial Hospital in Atlanta , Georgia , who met criterion A of DSM-IV PTSD received either 3 sessions of an exposure intervention , beginning in the emergency department shortly after trauma exposure or assessment only .


PTSD symptoms were assessed 4 and 12 weeks after trauma exposure .


A composite additive risk score was derived from polymorphisms in 10 previously identified genes associated with stress-response ( ADCYAP1R1 , COMT , CRHR1 , DBH , DRD2 , FAAH , FKBP5 , NPY , NTRK2 , and PCLO ) , and gene x treatment effects were examined .


The intervention included 3 sessions of imaginal exposure to the trauma memory and additional exposure homework .


The primary outcome measure was the PTSD Symptom Scale-Interview Version or DSM-IV-based PTSD diagnosis in patients related to genotype and treatment group .


A gene x intervention x time effect was detected for individual polymorphisms , in particular the PACAP receptor , ADCYAP1R1 , as well as with a combined genotype risk score created from independent SNP markers .


Subjects who did not receive treatment had higher symptoms than those who received intervention .


Furthermore , subjects with the `` risk '' genotypes who did not receive intervention had higher PTSD symptoms compared to those with the `` low-risk '' or `` resilience '' genotypes or those who received intervention .


Additionally , PTSD symptoms correlated with level of genetic risk at week 12 ( P < .005 ) in the assessment-only group , but with no relationship in the intervention group , even after controlling for age , sex , race , education , income , and childhood trauma .


Using logistic regression , the number of risk alleles was significantly associated with likelihood of PTSD diagnosis at week 12 ( P < .05 ) .


This pilot prospective study suggests that combined genetic variants may serve to predict those most at risk for developing PTSD following trauma .


A psychotherapeutic intervention initiated in the emergency department within hours of the trauma may mitigate this risk .


The role of genetic predictors of risk and resilience should be further evaluated in larger , prospective intervention and prevention trials .


ClinicalTrials.gov identifier : NCT00895518 .


Despite the general belief that mobility and exercise play an important role in the recovery of functional status , mobility is difficult to implement in patients in intensive care units .


To compare a mobility platform with standard equipment , assessing efficiency ( decreased time and staff required to prepare patient ) , effectiveness ( increased activity time ) , and safety ( no falls , unplanned tube removals , or emergency situations ) for intensive care patients .


This observational study was approved by the institutional review board , and informed consent was obtained from the patient or the medical decision maker .


Intensive care patients were assigned to a room in the usual manner , with platforms in odd-numbered rooms and standard equipment in even-numbered rooms .


Standardized data collection tools were designed to collect data for 24 hours for each patient .


The nurses caring for the patients completed the data collection tools in real time during the activity .


The stages of activity and the physiological states that would preclude mobility were very specifically defined for the research study .


Data were collected for a total of 71 patients and 238 activities .


Important ( although not significant ) descriptive statistics regarding early mobility in the intensive care unit were discovered .


The unintended result of the research study was a change in the culture and practice regarding early mobility in the intensive care unit .


Early mobility can be implemented in intensive care units .


Standard equipment can be used to mobilize such patients safely ; however , for patients who ambulate , a platform may increase efficiency and effectiveness .


This study aimed to compare sexual function before and 1 year after laparoscopic sacrocolpopexy using a porcine dermis or a polypropylene mesh material .


This was a secondary analysis of sexual function measured before and 1 year after laparoscopic sacrocolpopexy in a group of 81 sexually active women participating in a randomized controlled trial comparing porcine dermis and polypropylene mesh .


Sexual function was assessed using the short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire ( PISQ-12 ) .


Responses to individual questions from the physical domain of the PISQ-12 were also analyzed .


Additional information included the type of mesh material used and whether a concomitant suburethral sling or perineorrhaphy was performed .


There was a significant postoperative improvement in total PISQ-12 scores for the entire cohort ( 33.2 vs 38.3 , P < 0.01 ) .


Similarly , PISQ-12 scores were significantly improved in both groups ( 33.2 preoperative vs 37.4 one year postoperative in the porcine dermis , P < 0.01 and 33.2 vs 39.2 in the polypropylene mesh , P < 0.01 ) .


There were no differences between the 2 graft material groups .


Preoperatively , 63.0 % ( 48/76 ) of women reported avoiding sexual intercourse because of bulging in vagina ( PISQ12-question # 8 ) , at 1 year postoperatively only 4 % ( 3/76 ) had a positive response ( P < 0.01 ) .


We observed a significant decrease in the number of women who reported pain during intercourse at 12 months as evidenced by the responses to the PISQ12-question # 5 , 47.4 % ( 36/76 ) versus 26.3 % ( 20/76 ) ( P < 0.01 ) .


The addition of a suburethral sling or a perineorrhaphy did not negatively impact sexual function at 1 year .


Laparoscopic sacrocolpopexy had a positive impact on sexual function at 1 year regardless of whether a porcine dermis or a polypropylene mesh material was used .


The objective of this study was to investigate the effects of feeding a high-concentrate corn straw diet on the release of endotoxin in the rumen and the changes of pro-inflammatory cytokines in the mammary gland of dairy cows in comparison with a low-concentrate corn straw diet and a low-concentrate mixed forage diet .


Thirty second-parity Chinese Holstein cows in mid-lactation with a body condition score of 2.860.29 , weighing 54357kg and producing 24.323.86 kg milk per day were randomly assigned to 1 of the 3 diets ( n = 10 per treatment ) : 1 ) low-concentrate mixed forage diet ( LCF ) with a concentrate to roughage ratio of 46 : 54 ; 2 ) high-concentrate corn straw diet ( HCS ) with a concentrate to roughage ratio of 65 : 35 ; 3 ) low-concentrate corn straw diet ( LCS ) with the same concentrate to roughage ratio ( 46 : 54 ) as LCF .


The experiment lasted 6weeks , and samples were collected in the last week .


Milk samples were analyzed for conventional components , rumen fluid samples were analyzed for pH and endotoxin , and mammary arterial and venous plasma samples were analyzed for concentrations of interleukin ( IL ) -1 , IL-6 , IL-8 and tumor necrosis factor alpha ( TNF - ) .


Concentrations of endotoxin in rumen fluid and feces of cows fed HCS were significantly higher than those of cows fed LCS and LCF .


Feeding HCS increased the release of IL-1 , IL-6 and IL-8 in the mammary gland compared with feeding LCS .


Concentrations of cytokines ( IL-1 and IL-8 ) in mammary venous plasma had a negative correlation with milk production efficiencies .


Results indicated that the high-concentrate corn straw diet increased the concentrations of endotoxin in rumen fluid and feces .


Furthermore , feeding the high-concentrate corn straw diet stimulated the mammary gland to release more pro-inflammatory cytokines .


The results suggest that feeding a high-concentrate corn straw diet induce a higher pro-inflammatory response in the mammary gland and thus may partly decrease the milk production efficiencies in dairy cows .


Periprocedural thromboembolic and hemorrhagic events are worrisome complications of catheter ablation for atrial fibrillation ( AF ) .


The periprocedural anticoagulation management could play a role in the incidence of these complications .


Although ablation procedures performed without warfarin discontinuation seem to be associated with lower thromboembolic risk , no randomized study exists .


This was a prospective , open-label , randomized , parallel-group , multicenter study assessing the role of continuous warfarin therapy in preventing periprocedural thromboembolic and hemorrhagic events after radiofrequency catheter ablation .


Patients with CHADS2 score 1 were included .


Patients were randomly assigned in a 1:1 ratio to the off-warfarin or on-warfarin arm .


The incidence of thromboembolic events in the 48 hours after ablation was the primary end point of the study .


The study enrolled 1584 patients : 790 assigned to discontinue warfarin ( group 1 ) and 794 assigned to continuous warfarin ( group 2 ) .


No statistical difference in baseline characteristics was observed .


There were 39 thromboembolic events ( 3.7 % strokes [ n = 29 ] and 1.3 % transient ischemic attacks [ n = 10 ] ) in group 1 : two events ( 0.87 % ) in patients with paroxysmal AF , 4 ( 2.3 % ) in patients with persistent AF , and 33 ( 8.5 % ) in patients with long-standing persistent AF .


Only 2 strokes ( 0.25 % ) in patients with long-standing persistent AF were observed in group 2 ( P < 0.001 ) .


Warfarin discontinuation emerged as a strong predictor of periprocedural thromboembolism ( odds ratio , 13 ; 95 % confidence interval , 3.1-55 .6 ; P < 0.001 ) .


This is the first randomized study showing that performing catheter ablation of AF without warfarin discontinuation reduces the occurrence of periprocedural stroke and minor bleeding complications compared with bridging with low-molecular-weight heparin .


http://www.clinicaltrials.gov .


Unique identifier : NCT01006876 .


Exercise maintenance after completing phase II cardiac rehabilitation ( CR ) is challenging for many patients .


A telephone-based maintenance intervention improved exercise participation compared with a control group at 12 months post-CR discharge .


We examined the 6-month mediators of intervention effects on exercise .


In a randomized controlled trial , 130 patients who had completed CR ( mean age : 63.6 [ SD = 9.7 ] years , 20.8 % female ) were randomized to Maintenance Counseling ( n = 64 ) or Contact Control ( n = 66 ) .


Putative mediators examined the following : self-efficacy , behavioral processes of change , decisional balance index , social support for exercise , and enjoyment of exercise .


Multiple mediation analyses showed that the intervention significantly increased social support from friends at 6 months but not the other constructs .


Decreasing support from friends mediated greater exercise participation in Maintenance Counseling than in Contact Control at 12 months .


Social support from friends functioned as a suppressor mediator for exercise maintenance among cardiac patients .


To explore the effect of single-dose dexmedetomidine on recovery period after sevoflurane anesthesia with spontaneous respiration in pediatric patients undergoing cleft lip and palate repair .


A total of 60 American Society of Anesthesiologists ( ASA ) I-II pediatric patients undergoing cleft lip and palate repair from October to December 2013 were randomly divided into groups D and C ( n = 30 each ) .


Dexmedetomidine 0.5 g/kg ( group D ) or an equal volume of normal saline ( group C ) was ad ministered intravenously over a period of 10 min at 30 min before the end of surgery .


Anesthesia was induced and maintained with sevoflurane under spontaneous ventilation .


Heart rate , mean arterial pressure ( MAP ) , hemoglobin oxygen saturation ( SpO2 ) , respiratory rate , tidal volume ( VT ) and pressure of end-tidal carbon dioxide ( PETCO2 ) were recorded at the time before induction ( T0 ) , 30 min before the end of surgery ( T1 ) , 20 min before the end of surgery ( T2 ) , 15 min before the end of surgery ( T3 ) , 10 min before the end of surgery ( T4 ) , the end of surgery ( T5 ) , extubation ( T6 ) , 5 min after transferal into post-anesthesia care unit ( PACU ) ( T7 ) , 1 h after surgery ( T8 ) , extubation time , length of PACU stay , fentanyl consumption and adverse events were all recorded .


The incidence and severity of coughing and emergence agitation were assessed .


Compared to T0 , MAP and heart rate at T1 to T5 all decreased in two groups ( P < 0.05 ) .


MAP and heart rate at T6 both increased in two groups and group C was higher than group D ( P < 0.05 ) .


No inter-group differences existed in SpO2 , respiratory rate , VT or PETCO2 .


The incidence of coughing and emergence agitation ( 30 % and 13.3 % ) , fentanyl consumption of group D ( 0.8 2.1 g ) were all significantly lower than that of group C [ ( 66.7 % vs 56.7 % ) and ( 4.9 6.50 ) g , P < 0.05 ] .


Length of PACU stay in group D was shorter than that in group C [ ( 15 6 ) vs ( 23 19 ) min , P < 0.05 ] .


No inter-group difference existed in extubation time or adverse events .


A single intravenous dose of dexmedetomidine is effective in reducing emergence agitation and coughing , shortening length of PACU stay and improving the quality of recovery period after sevoflurane anesthesia in pediatric patients undergoing cleft lip and palate repair .


To test whether subsensory vibratory noise applied to the sole of the foot using a novel piezoelectric vibratory insole can significantly improve sensation , enhance balance , and reduce gait variability in elderly people , as well as to determine the optimal level of vibratory noise and whether the therapeutic effect would endure and the user 's sensory threshold would remain constant during the course of a day .


A randomized , single-blind , crossover study of 3 subsensory noise stimulation levels on 3 days .


Balance and gait laboratory .


Healthy community-dwelling elderly volunteers ( N = 12 ; age , 65-90y ) who could feel the maximum insole vibration .


A urethane foam insole with the piezoelectric actuators delivering subsensory vibratory noise stimulation to the soles of the feet .


Balance , gait , and timed Up and Go ( TUG ) test .


The vibratory insoles significantly improved performance on the TUG test , reduced the area of postural sway , and reduced the temporal variability of walking at both 70 % and 85 % of the sensory threshold and during the course of a day .


Vibratory sensation thresholds remained relatively stable within and across study days .


This study provides proof of concept that the application of the principle of stochastic resonance to the foot sole sensory system using a new low-voltage piezoelectric technology can improve measures of balance and gait that are associated with falls .


Effective vibratory noise amplitudes range from 70 % to 85 % of the sensory threshold and can be set once daily .


One of the primary goals of endoscopic sinus surgery ( ESS ) is to create widely patent paranasal sinus ostia , but lateralization of the middle turbinate ( MT ) after ESS can obstruct otherwise patent ethmoid and maxillary sinuses .


The aim of this study was to evaluate the effectiveness of turbinate-septal suturing in preventing lateralization of the MT.


A prospective , randomized , blinded controlled study .


The study was performed in 120 patients who had undergone ESS .


The patients were randomized to receive nasal ( group A ) or turbinate-septal suture plus nasal packing ( group B ) .


Postoperative lateralization of the MT and synechia formation were assessed as the primary outcome 3 months post-ESS .


The Lund-Kennedy Scores at 1 week , 2 week , and 1 month after ESS were assessed as the secondary outcomes .


A total of 120 patients were enrolled ( 60 patients in each group ) .


Group B had a significantly lower rate of MT lateralization compared to group A after 3 months of surgery ( 6 of 120 sides vs. 19 of 120 sides ; P < 0.01 ) .


Synechia formation rates in groups B were also significantly lower than those in group A ( 4 of 120 sides vs. 13 of 120 sides ; P = 0.023 ) .


Middle turbinate-septal suturing medialization during ESS is an effective method for preventing lateralization of the MT.


To investigate the effect of `` Xinjingjie compound lysostaphin antibacterial collutorium '' on prevention and treatment of radiation-induced oral mucositis in a prospective , randomized and double-blind clinical trial .


Sixty patients with oral cancer to be treated with radiotherapy were randomized into the experimental and control group .


The experimental group ( 30 patients ) was treated with `` Xinjingjie mouthrinse '' during the full course of radiotherapy , 4 times daily with 5 mL and 5 min each time .


The control group ( 30 patients ) rinsed the mouth in the same way with normal saline .


Oral mucositis was assessed according to the RTOG criteria .


The severity of mucositis and the degree of pain were recorded and photographed .


Patients should n't be treated with other drugs until the level of oral mucositis reached above grade III .


The results were statistically analyzed using Stata 12.0 software packages .


Age , gender , radiotherapy techniques and dose showed no significant difference between the 2 groups ( P > 0.05 ) .


The first onset of oral mucositis in the experimental group was later than that in the control group ( 11.0 times :9.1 times , P < 0.05 ) , and the incidence of pain at the early time of radiotherapy was lower ( 36.7 % : 70.0 % , P < 0.05 ) .


Also , the onset time of grade III oral mucositis in the emperimental group was later than that in the control group ( 18.9 times :15.9 times , P < 0.05 ) , and the incidence of grade III oral mucositis in the experimental group was lower ( 63.3 % vs. 90.0 % , P < 0.05 ) .


`` Xinjingjie mouthrinse '' is worthwhile to be used in clinic because it can delay the occurrence time of radiation-induced oral mucositis , alleviate pain and reduce the indication of grade III oral mucositis .


To assess the potential therapeutic effect of intratendinous injection of platelet-rich plasma ( PRP ) under ultrasound ( US ) guidance to treat tendon tears and tendinosis in a pilot study with long-term follow-up .