Single dose of ZST administered in the middle of the night at @ and @ h before driving , zopiclone @ mg at bedtime @ h before driving , and placebo .


Performance in a @-km standardized highway driving test in normal traffic measuring standard deviation of lateral position ( SDLP ) - an index of weaving .


Drug-placebo changes in SDLP > @ cm were considered to reflect clinically relevant driving impairment .


For ZST , Max McNemar symmetry analyses showed that the proportion of drivers classified as impaired was increased @ h after dosing ( P < @ ) , but not @ h after dosing .


Mean increases in SDLP from placebo , although statistically significant , were small ( @ cm -LSB- P < @ -RSB- at @ h and @ cm -LSB- P = @ -RSB- at @ h ) .


The morning after zopiclone , @ % of the drivers were classified as impaired with a mean increase in SDLP of @ cm ( P < @ ) .


There were no significant sex differences in effects of ZST and zopiclone .


Zolpidem @ mg in a buffered sublingual formulation has a minimal risk of impairing driving performance in the morning @ hours after middle-of-the night use .


When taken @ hours before driving , the drug may have impairing effects so caution should be exercised if medication is taken other than as indicated .


Pneumonia is the leading cause of childhood mortality globally .


Respiratory syncytial virus ( RSV ) is the most important viral cause of pneumonia .


Maternal serum antibody protects infants from RSV disease .


The objective of our study was to characterize RSV antibody levels in mother-infant pairs .


Serial serum samples were collected from mother-infant pairs in Bangladesh from the third trimester of pregnancy to @ weeks postpartum and tested using an RSV antibody microneutralization assay .


Serologic infection was defined as a @-fold increase in antibody titer .


Maternal antibody half-life was calculated using infant antibody titers from birth to @ weeks .


The ratio of infant cord blood to maternal serum RSV antibody titers in @ mother-infant pairs was @ ( @ % confidence interval -LSB- CI -RSB- , @ -@ ) .


Maternal RSV antibody titers in the third trimester and at birth were strongly correlated ( R = @ ) .


Antibody half-life was @ days ( @ % CI , @-@ days ) .


Higher cord blood RSV antibody titers were associated with a lower risk of serologic infection ( P = @ ) and maintenance of antibody titer above a potentially protective threshold ( P < @ ) .


Efficient transplacental transfer of RSV-specific antibody from mother to the fetus was documented in mother-infant pairs in Asia .


Higher cord blood antibody titers were associated with protection from serologic infection .


Although women with substance use disorders ( SUDs ) have high rates of trauma and posttraumatic stress , many addiction programs do not offer trauma-specific treatments .


One promising intervention is Pennebaker 's expressive writing , which involves daily , @-minute writing sessions to facilitate disclosure of stressful experiences .


Women ( N = @ ) in residential treatment completed a randomized clinical trial comparing expressive writing with control writing .


Repeated-measures analysis of variance was used to document change in psychological and physical distress from baseline to @-week and @-month follow-ups .


Analyses also examined immediate levels of negative affect following expressive writing .


Expressive writing participants showed greater reductions in posttraumatic symptom severity , depression , and anxiety scores , when compared with control writing participants at the @-week follow-up .


No group differences were found at the @-month follow-up .


Safety data were encouraging : although expressive writing participants showed increased negative affect immediately after each writing session , there were no differences in pre-writing negative affect scores between conditions the following day .


By the final writing session , participants were able to write about traumatic/stressful events without having a spike in negative affect .


Results suggest that expressive writing may be a brief , safe , low-cost , adjunct to SUD treatment that warrants further study as a strategy for addressing posttraumatic distress in substance-abusing women .


Low serum bicarbonate level has been reported to be an independent predictor of kidney function decline and mortality in patients with chronic kidney disease .


Mechanisms underlying low serum bicarbonate levels may differ in patients with and without diabetes .


We aimed to specifically investigate the association of serum bicarbonate level with kidney disease progression and cardiovascular outcome in a cohort of patients with type @ diabetes and nephropathy .


Post hoc analysis of @ multicenter randomized controlled trials .


@,@ adults with type @ diabetes and nephropathy .


Serum bicarbonate level .


Incidence of : ( @ ) end-stage renal disease ( ESRD ) , ( @ ) ESRD or doubling of serum creatinine level , ( @ ) all-cause mortality , ( @ ) cardiovascular events ( fatal/nonfatal stroke/myocardial infarction ) , and ( @ ) heart failure .


Serum bicarbonate was measured at baseline as total carbon dioxide .


Associations of baseline serum bicarbonate level with end points were investigated using Cox regression models .


Serum bicarbonate levels were studied as a continuous variable and stratified in quartiles .


Follow-up was @ ( SD ) years .


Cox regression analyses showed that serum bicarbonate level had inverse associations with incident ESRD ( HR , @ ; @ % CI , @-@ @ ; P < @ ) and incidence of the combined end point of ESRD or serum creatinine doubling ( HR , @ ; @ % CI , @-@ @ ; P < @ ) .


These associations were independent of age , sex , and cardiovascular risk factors , but disappeared after adjustment for baseline estimated glomerular filtration rate ( all P > @ ) .


Analysis of bicarbonate quartiles showed similar results for the quartile with the lowest bicarbonate ( @ mEq/L ) versus the quartile with normal bicarbonate levels ( @-@ mEq/L ) .


There was no association of bicarbonate level with cardiovascular events and heart failure .


Post hoc analysis and single measurement of serum bicarbonate .


In this cohort of patients with type @ diabetes with nephropathy , serum bicarbonate level associations with kidney disease end points were not retained after adjustment for estimated glomerular filtration rate , which is in contrast to results of earlier studies in nondiabetic populations .


Barbed suture material offers the possibility of knotless flexor tendon repair , as suggested in an increasing number of biomechanical studies .


There are currently two different absorbable barbed suture products available , V-Loc and Stratafix , and both have not been compared to each other with regard to flexor tendon repair .


The purpose of this study was to evaluate both suture materials for primary stability under static and cyclic loading in a biomechanical ex vivo model .


Forty fresh porcine flexor digitorum profundus tendons were randomized in two groups .


A four-strand modified Kessler suture technique was used to repair the tendon either with a @-@ V-Loc or @-@ Stratafix without a knot .


Parameters of interest were mode of failure , @-mm gap formation force , displacement , stiffness and maximum load under static and cyclic testing .


The maximum load was @ for the Stratafix group and @ N for the V-Loc group .


Thus , the ultimate tensile strength was significantly higher for V-Loc ( p < @ ) .


The @-mm gap occurred at @ N in the Stratafix group in comparison to @ N in the V-Loc group ( n.s. ) .


Displacement was @ mm in the V-Loc group and @ mm in the Stratafix group ( n.s. ) .


Stiffness was @ ( N/mm ) in the V-Loc group and @ ( N/mm ) the Stratafix group ( n.s. ) .


Those measured differences were not significant .


V-Loc demonstrates a higher maximum load in tendon reconstruction .


The differences in @-mm gap formation force , displacement and stiffness were not significant .


Hereby , the V-Loc has an advantage when used as unidirectional barbed suture for knotless flexor tendon repair .


Collateral artery growth ( arteriogenesis ) is an important adaptive response to hampered arterial perfusion .


It is unknown whether preventive physical exercise before limb ischemia can improve arteriogenesis and modulate mononuclear cell function .


This study aimed at investigating the effects of endurance exercise before arterial occlusion on MNC function and collateral artery growth .


After @ weeks of voluntary treadmill exercise , ligation of the right femoral artery was performed in mice .


Hindlimb perfusion immediately after surgery did not differ from sedentary mice .


However , previous exercise improved perfusion restoration @ days after femoral artery ligation , also when exercise was stopped at ligation .


This was accompanied by an accumulation of peri-collateral macrophages and increased expression of endothelial nitric oxide synthase and inducible nitric oxide synthase ( iNOS ) in hindlimb collateral and in MNC of blood and spleen .


Systemic monocyte and macrophage depletion by liposomal clodronate but not splenectomy attenuated exercise-induced perfusion restoration , collateral artery growth , peri-collateral macrophage accumulation , and upregulation of iNOS .


iNOS-deficient mice did not show exercise-induced perfusion restoration .


Transplantation of bone marrow-derived MNC from iNOS-deficient mice into wild-type animals inhibited exercise-induced collateral artery growth .


In contrast to sedentary controls , thrice weekly aerobic exercise training for @ months in humans increased peripheral blood MNC iNOS expression .


Circulating mononuclear cell-derived inducible nitric oxide is an important mediator of exercise-induced collateral artery growth .


We prospectively evaluated the efficacy of dissolution therapy and standard shock wave lithotripsy as a noninvasive modality for radiolucent renal stones in children .


A total of @ children with radiolucent renal calculi were included in study .


Median age was @ years ( range @ to @ ) .


Computerized tomography was done to confirm a stone density of less than @ HU .


Median stone length was @ mm ( range @ to @ ) .


Patients were randomly divided into @ groups .


The medical group of @ patients received potassium sodium hydrogen citrate at a dose of @ mEq/kg per day for @ to @ months .


The shock wave lithotripsy group of @ patients were treated with a Lithotripter S ( Dornier Medtech , Kennesaw , Georgia ) while under general anesthesia .


Complications in each group were recorded .


Patients were considered stone free when imaging within @ months showed no evidence of stones .


The stone-free rate was @ % for dissolution therapy vs @ % after a single session of shock wave lithotripsy ( p = @ ) .


One patient per group experienced a pyelonephritis episode during followup ( p = @ ) .


Three of the @ patients in whom medical regimens failed were noncompliant and @ ingested the medication sporadically .


Medical dissolution therapy is a well tolerated , effective treatment for radiolucent renal stones in children .


It eliminates the need for shock wave lithotripsy in up to @ % of cases .


The management of patients suffering from opioid-refractory cancer pain with a neuropathic component remains an important challenge for healthcare workers .


Only one retrospective study specifically reported the use of intravenous ( IV ) lidocaine amongst the palliative care unit population , the study found that there was a positive response to this therapy .


These preliminary uncontrolled results need to be confirmed by randomized controlled trials .


The primary objective of this study is to assess the analgesic efficacy of IV lidocaine in patients in palliative care suffering from opioid-refractory cancer pain with a neuropathic component .


The secondary objectives are to assess the tolerance of , symptomatology , and patient satisfaction with the therapeutic approach .


This will be a multicenter , prospective , randomized , placebo-controlled , double-blind , two-parallel group study .


It will take place in eight adult palliative care units across France .


The main inclusion criteria are as follows : adult patients suffering from opioid-refractory cancer pain with a neuropathic component , and those receiving palliative care as defined by French Society of Palliative and Support Care .


Participants will be randomized ( @:@ allocation ratio ) to one of two treatment groups : a ) lidocaine-experimental group ( intravenous lidocaine ) , or b ) placebo-control group ( intravenous saline solution ) .


Evaluation assessments will be taken at baseline ( T@ randomization ) , @ minutes ( T@ ) , @ minutes ( T@ ) , @ hours ( T@ ) , @ hours ( T@ ) , @ hours ( T@ ) , and @ days ( T@ ) after baseline .


The primary endpoint is change in the pain level between T@ and T@ .


The secondary endpoints are : changes in the pain level between T@ and other times , intensity of the neuropathic pain component , daily opioid consumption , symptoms ( as classified by the MD Anderson Symptom Inventory ) , adverse events , and patient 's satisfaction ( measured using the Pain Treatment Satisfaction Scale ) .


A sample size of @ individuals will be needed to obtain @ % power to detect a @ % difference in pain success at T@ between the two groups ; pain success is classified as a @ % decrease in the pain level between T@ and T@ ( @ % of patients lost to follow-up expected ) .


The randomized , double-blind , placebo-controlled design is the most appropriate design to demonstrate the efficacy of a new experimental intervention ( Evidence-Based Medicine Working Group classification ) .


National and international recommendations could be updated based on the findings of this study .


Pelvic organ prolapse ( POP ) is a common and distressing condition .


The aim of the present study was to evaluate the effect ofpelvic floor muscle training ( PFMT ) on prevention and treatment ofsymptoms and signs of POP in primiparous postpartum women .


This was a parallel group assessor blind randomized controlled trial .


One hundred seventy-five primiparous postpartum women , mean age @ years ( standard deviation @ ) , stratified on major levator ani defects or no defect diagnosed by @ - / @-dimensional ultrasound , participated in a @-month PFMT starting at @-@ weeks ' postpartum or control .


All participants had thorough individual instruction and assessment of ability to perform correct pelvic floor muscle contractions .


The PFMT group followed a supervised , weekly group training program and performed @ sets of @-@ daily maximal contractions at home .


Main outcome was POP stage II or greater assessed by POP quantification and bladder neck position assessed by @ - / @ - dimensional transperineal ultrasonography .


Secondary outcome was symptoms of vaginal bulge using International Consultation on Incontinence Vaginal Symptoms questionnaire .


Ninety-six percent of the intervention group adhered to @ % of both group and home training sessions .


At postintervention , there was no significant risk difference in POP ( rational ratio , @ ; @ % confidence interval , @-@ @ ) , bladder neck position or symptoms of vaginal bulging .


No effect was found of postpartum PFMT on POP in primiparous women .


More randomized controlled trials are needed before strong conclusions can be drawn on the effect of PFMT on POP in the particular population .


To investigate the efficacy , safety , and clinical benefit of prolonged-release trazodone ( Trittico ) in the treatment of major depressive disorder ( MDD ) .


In this study , @ Chinese patients with MDD were randomized @:@ to receive either prolonged-release trazodone ( @-@ mg ) or placebo treatment for @ weeks .


The primary efficacy measurement was the change of the @-item Hamilton Depression Rating Scale ( HAMD-@ ) total score from baseline to the end of the study .


The secondary efficacy measurements were the response and remission rates , the Clinical Global Impression - Improvement of Illness ( CGI-I ) score at the end of the study , and the change of the HAMD-@ total score and quality of sleep -LSB- evaluated by the Pittsburgh Sleep Quality Index ( PSQI ) scale -RSB- during the study period .


The mean maximum daily dose was @ mg for the trazodone group and @ mg for the placebo group .


At the end of the study , there was a significant difference between the two groups in the HAMD-@ change score ( trazodone vs. placebo : -@ vs. -@ , p < @ ) .


Trazodone showed advantages at @ week of treatment , and the effect lasted until the end of the study ( week @ ) .


The response and remission rates of the trazodone group were significantly higher than those in the placebo group ( response rate : @ vs. @ % , p < @ ; remission rate : @ vs. @ % , p = @ ) .


The majority of the adverse reactions of trazodone were mild to moderate , and the most frequent adverse reactions ( @ % ) were dizziness , dry mouth , somnolence , and nausea .


Prolonged-release trazodone was more effective than placebo in MDD and was well tolerated .


Psoriasis is a common skin disease with extensive comorbidity risks , which may affect multiple aspects of life .


Self-management is essential for skin treatment and lifestyle choices , but few disease-specific tailored self-management and educational programmes appear to be available .


To evaluate the effects of a @-month individual motivational interviewing intervention in patients with psoriasis ( with a total follow-up of @ months ) after climate therapy/heliotherapy ( CHT ) .


A randomized controlled trial with @ patients with psoriasis was conducted in the context of CHT at Gran Canaria , Spain .


The main outcome measures were Self-Administered Psoriasis Area and Severity Index ( SAPASI ) and Health Education Impact Questionnaire ( heiQ ) , and the secondary outcomes were illness perception , psoriasis knowledge and lifestyle change assessments .


Outcomes were measured at baseline , after @ weeks of CHT , and @ months and @ months later .


There were significant overall treatment effects in the study group in terms of the SAPASI score , three self-management domains of heiQ and the self-efficacy scores ( P < @ ) .


The lifestyle change parameters were significantly better in the study group .


Illness perception differed between the groups at @ months ( P = @ ) , and psoriasis knowledge was significantly better in the study group at @ months ( P = @ ) .


A @-month motivational interviewing intervention following CHT had positive overall effects on disease severity , self-efficacy , psoriasis knowledge and health behaviour change .


This approach has the potential to be an important complement to medical management , self-management and education in patients with psoriasis .


Stopwatch-assessed duration of erection has been proposed as an objective and reliable efficacy end point for erectile dysfunction ( ED ) treatments .


The aim of this study is to assess vardenafil orodispersible tablets ' ( ODTs ) efficacy in terms of duration of erection and ( i ) its correlation with other efficacy end points and male and female sexual quality of life ( QoL ) and ( ii ) its impact on intercourse duration .


Randomized , double-blind , placebo-controlled , multicenter study comparing the efficacy and safety of vardenafil ODT @mg on-demand over @ weeks in @ patients with ED was carried out .


Primary efficacy end points were stopwatch-assessed duration of erection ( min ) at any attempt and when leading to successful intercourse , and the erectile function domain of the International Index of Erectile Function ( EF-IIEF ) score .


Secondary end points were sexual encounter profile ( SEP ) @ response rate and male sexual QoL .


End points in participating women ( N = @ ) were stopwatch-assessed duration of intercourse and sexual QoL .


At week @/last observation carried forward , patients taking vardenafil ODT had longer duration of erections ( at any attempt or leading to successful intercourse ) vs. placebo ( least square meanstandard error @ minutes vs. @ minutes , and @ vs. @ minutes , respectively ) , and significant increases in EF-IIEF scores , the SEP-@ response , and all sexual QoL items .


An increased duration of intercourse was also observed .


Female sexual QoL improved significantly .


Both duration end points strongly correlated with EF-IIEF scores , and the three end points correlated well with SEP-@ response .


Correlation was good with sexual QoL scores in men and women and with duration of intercourse , with differences between treatment groups only for duration end points .


Safety was similar in both groups .


This study provides further evidence for the consistency and reliability of the stopwatch-assessed duration of erection as an efficacy end point for ED treatments , with `` duration of erection leading to successful intercourse '' showing better properties than duration at any attempt .


Health-related quality of life ( QoL ) has prognostic value in many cancers .


A recent study found that the performance of prognostic systems for metastatic colorectal cancer ( mCRC ) were improvable .


We evaluated the independent prognostic value of QoL for overall survival ( OS ) and its ability to improve two prognostic systems ` performance ( Khne and GERCOR models ) for patients with mCRC .


The EQ-@D questionnaire was self-completed before randomization in the OPTIMOX@ , a phase III trial comparing two strategies of FOLFOX chemotherapy which included @ previously untreated mCRC patients recruited from January @ to June @ from @ institutions in five countries .


The improvement in models ' performance ( after addition of QoL ) was studied with Harrell 's C-index and the net reclassification improvement .


Of the @ patients , @ ( @ % ) completed QoL datasets .


The Khne model could be improved by LDH , mobility and pain/discomfort ; the C-index rose from @ to @ .


The associated NRI for @-month death was @ -LSB- @ ; @ -RSB- .


Mobility and pain/discomfort could be added to the GERCOR model : the C-index varied from @ to @ .


The NRI for @ months death was @ -LSB- @ ; @ -RSB- .


Mobility and pain dimensions of EQ@D are independent prognostic factors and could be useful for staging and treatment assignment of mCRC patients .


Presented at the @ ASCO Annual Meeting ( # @ ) .


To evaluate the safety of uninterrupted rivaroxaban , a novel oral anticoagulant that directly inhibits factor Xa , and a vitamin K antagonist ( VKA ) in eligible adult patients with nonvalvular AF ( NVAF ) who are scheduled for a catheter ablation .


This is a prospective , randomized , open-label , active-controlled , global multicenter safety study of up to @ randomized patients .


Eligible patients with paroxysmal or persistent NVAF , a left ventricular ejection fraction > @ % , and a creatinine clearance > @mL/min will be randomized @:@ to rivaroxaban @mg orally once daily or to dose-adjusted oral VKA ( recommended international normalized ratio ( INR ) @-@ @ ) and stabilized on anticoagulation therapy for @-@days ( if no intracardiac thrombus on transesophageal echocardiogram ( TEE ) immediately prerandomization/post-randomization or if @weeks of sufficient anticoagulation is documented ) or for @-@weeks ( if no TEE , no documented @weeks of sufficient anticoagulation , or by patient choice ) .


During catheter ablation , heparin will be administered ( ACT-targeted range = @-@s ) after catheter ablation , and VKA will be managed per usual care .


The next dose of rivaroxaban will be provided at least @h after establishment of hemostasis .


The primary endpoint will be the incidence of post-procedure major bleeding events observed during the first @days post-ablation .


Secondary endpoints will include post-procedure thromboembolic events , additional bleeding , time-to-event , and medication adherence .


This study is intended to provide information about the safety characteristics of rivaroxaban in patients with NVAF undergoing catheter ablation .


Isoperistaltic stapled side-to-side anastomosis ( SSSA ) , which is a modified technique from conventional antiperistaltic SSSA , has the benefits of antiperistaltic SSSA but requires less intestinal mobility .


The aim of this randomized controlled trial was to evaluate short-term outcomes of isoperistaltic SSSA comparing them with antiperistaltic SSSA during colon cancer surgery .


We conducted a randomized controlled trial of patients with colon cancer who underwent elective curative resection and had enough intestinal mobility at anastomosis .


The primary outcome was the presence of anastomotic failure , including leakage , hemorrhage , and stenosis .


Between July @ and January @ , forty patients were enrolled ( @ patients in each group ) .


The study was suspended on detecting excess morbidity in the isoperistaltic SSSA group .


No significant differences were observed in all preoperative backgrounds between the two groups .


Anastomotic leakage was seen in two patients in the isoperistaltic SSSA group , compared with none in the antiperistaltic SSSA group , although the difference was not statistically significant ( P = @ ) .


One patient in the antiperistaltic SSSA group had anastomotic stenosis , which improved conservatively , compared with none in the isoperistaltic SSSA group ( P = @ ) .


No anastomotic hemorrhage was seen in either group .


There was no significant difference in the median postoperative hospital stay ( P = @ ) .


This study did not show any short-term advantage or disadvantage of isoperistaltic SSSA compared with that of antiperistaltic SSSA .


However , considering that anastomotic leakage occurred only in the isoperistaltic SSSA group , additional modifications are recommended to perform safe isoperistaltic SSSA for colon surgery .


To compare the extraction time and infection rate of umbilical cord by applying ethanol , humanmilk or dry care .


The parallel single-blinded randomised clinical trial was performed on @ neonates at Shahid Sadougi University of Medical Sciences and Health Service , Yazd , Iran , between March and September @ .


The neonates were divided into three random but numerically equal groups .


Each group was assigned the application of ethanol or mother 's milk or to keep the stump dry .


The neonates were visited on the @rd and the @th day after birth and follow-up was maintained telephonically until umbilical separation .


Umbilical separation time and umbilical local infection frequency were considered as the study outcome , which was compared among the three groups according to age , gender and delivery type of the neonates .


Umbilical separation time in neonates of the human milk group had significant difference with the ethanol group ( p = @ ) and drying groups ( p = @ ) .


Frequency of omphalitis had no significant difference among the three groups .


Topical usage of human milk on umbilical cord stamp decreased separation time and incidence rate of omphalitis .


This study was designed to determine whether the volume and type of fluid administered for pancreaticoduodenectomy impacts postoperative outcomes .


Three percent hypertonic saline ( HYS ) has been suggested as a means of reducing the volume of fluid required to sustain tissue perfusion in the perioperative period .


Between May @ and November @ , patients undergoing pancreaticoduodenectomy were enrolled in an institutional review board-approved , single-center , prospective , parallel , randomized controlled trial ( NCT @ ) , comparing lactated Ringers ( LAR ) ( @ mL/kg/hr LAR intraoperation , @ mL/kg/hr LAR postoperation ) with HYS ( @ mL/kg/hr LAR and @ mL/kg/hr HYS intraoperation , @ mL/kg/hr HYS postoperation ) .


A total of @ patients were randomized .


Demographic variables between groups were similar .


The HYS patients had a significantly reduced net fluid balance ( @ vs @ mL/kg , P = @ ) .


The overall complication rate was reduced in the HYS group ( @ % vs @ % ) , with a relative risk of @ -LSB- @ % confidence interval ( CI ) , @-@ @ ; P = @ -RSB- , factoring stratification for pancreas texture .


After adjustment for age and weight , the relative risk was @ -LSB- @ % CI ( @-@ @ ) ; P = @ -RSB- .


The total number of complications was significantly reduced in the HYS group ( @ vs @ ) , with an incidence rate ratio of @ -LSB- @ % CI ( @-@ @ ) ; P = @ -RSB- .


After adjustment for age and weight , the incidence rate ratio was @ -LSB- @ % CI ( @-@ @ ) ; P = @ -RSB- .


Reoperations , length of stay , readmissions , and @-day mortality were similar between groups .


A moderately restrictive fluid regimen with HYS resulted in a statistically significant @ % reduction in complications when adjusted for age , weight , and pancreatic texture .


Kiwifruit contains bioactive substances that may lower blood pressure ( BP ) and improve endothelial function .


We examined the effects of adding kiwifruit to the usual diet on @-h ambulatory BP , office BP and endothelial function .


In a parallel-groups study , @ subjects with high normal BP or stage @ hypertension ( systolic BP @-@ mmHg and/or diastolic BP @-@ mmHg ) were randomized to intake of three kiwifruits ( intervention ) or one apple ( control ) a day for @ weeks .


Office and @-h ambulatory BP was measured along with biomarkers of endothelial function including metabolites of nitric oxide ( NO ) formation and finger photo-plethysmography .


At randomization , mean @-h ambulatory systolic/diastolic BP was @ @/@ @ mmHg ( n = @ ) .


After @ weeks , BP was lower in the group assigned to kiwifruit versus apple intake ( between group difference , - @ mmHg -LSB- @ % CI - @ to - @ -RSB- , p = @ and - @ mmHg -LSB- @ % CI - @ to - @ -RSB- ; p = @ , for systolic and diastolic BP , respectively ) .


Changes in office BP and endothelial function did not differ between the groups .


Among men and women with moderately elevated BP , intake of three kiwifruits was associated with lower systolic and diastolic @-h BP compared with one apple a day .


The effect may be regulated by mechanisms other than improvement of endothelial function .


The study objective was to assess the efficacy of problem-solving therapy for primary care ( PST-PC ) for preventing episodes of major depression and mitigating depressive symptoms of older black and white adults .


The comparison group received dietary coaching .


A total of @ participants ( @ blacks , @ whites , and three Asians ) with subsyndromal depressive symptoms were recruited into a randomized depression prevention trial that compared effects of individually delivered PST-PC and dietary coaching on time to major depressive episode and level of depressive symptoms ( Beck Depression Inventory ) over two years .


Cumulative intervention time averaged @-@ @ hours in each study arm .


The two groups did not differ significantly in time to major depressive episodes , and incidence of such episodes was low ( blacks , N = @ , @ % ; whites , N = @ , @ % ) , compared with published rates of @ % -@ % over one year among persons with subsyndromal symptoms and receiving care as usual .


Participants also showed a mean decrease of @ points in depressive symptoms , sustained over two years .


Despite greater burden of depression risk factors among blacks , no significant differences from whites were found in the primary outcome .


Both PST-PC and dietary coaching are potentially effective in protecting older black and white adults with subsyndromal depressive symptoms from developing episodes of major depression over two years .


Absent a control for concurrent usual care , this conclusion is preliminary .


If confirmed , both interventions hold promise as scalable , safe , nonstigmatizing interventions for delaying or preventing episodes of major depression in the nation 's increasingly diverse older population .


To evaluate the effect of @-week moderate intensity aerobic ( heart-rate reserve @-@ % ) exercise on neuropathy quality of life in type @ diabetes .


A single blind , parallel-group , randomized controlled trial was carried out in a tertiary setting .


People with type @ diabetes were eligible for the study if they had clinical neuropathy which was defined by a minimum score of seven on the Michigan diabetic neuropathy score .


Following which , the patients were randomly assigned to an @-week program by a computer-generated random number tables to intervention or control group .


Repeated measure analysis of variance was used for data analysis ( p < @ was considered significant ) .


There were @ participants in the control group and @ participants in the study group after randomization but @ from the control group and @ from the intervention group completed the final analysis .


The two groups had a significant difference , pre-post intervention in scores of pain ( F = @ , p = @ ) , sensory symptoms ( F = @ , p = @ ) , restricted activities of daily living ( F = @ , p = @ ) , disruptions in social relationships ( F = @ , p = @ ) , specific impact on quality of life ( F = @ , p < @ ) overall quality of life ( F = @ , p < @ ) , and total score ( F = @ , p < @ ) .


Degrees of freedom for all the components were @ , @ .


Moderate intensity aerobic exercise is cornerstone in improving the quality of life of individuals with peripheral neuropathy in type @ diabetes .


We examined whether It 's Your Game ... Keep It Real ( IYG ) reduced dating violence among ethnic-minority middle school youths , a population at high risk for dating violence .


We analyzed data from @ predominantly ethnic-minority students from @ middle schools in southeast Texas in @ for a group randomized trial of IYG .


We estimated logistic regression models , and the primary outcome was emotional and physical dating violence perpetration and victimization by ninth grade .


Control students had significantly higher odds of physical dating violence victimization ( adjusted odds ratio -LSB- AOR -RSB- = @ ; @ % confidence interval -LSB- CI -RSB- = @ , @ ) , emotional dating violence victimization ( AOR = @ ; @ % CI = @ , @ ) , and emotional dating violence perpetration ( AOR = @ ; @ % CI = @ , @ ) than did intervention students .


The odds of physical dating violence perpetration were not significantly different between the @ groups .


Program effects varied by gender and race/ethnicity .


IYG significantly reduced @ of @ dating violence outcomes among ethnic-minority middle school youths .


Although further study is warranted to determine if IYG should be widely disseminated to prevent dating violence , it is one of only a handful of school-based programs that are effective in reducing adolescent dating violence behavior .


To explore the effect of intravariceal-mucosal sclerotherapy using small dose of sclerosant on the recurrence of esophageal varices .


We randomly assigned @ cirrhotic patients with previous variceal bleeding and high variceal pressure ( > @ mmHg ) to receive endoscopic variceal ligation ( EVL ) and combined intravariceal and esophageal mucosal sclerotherapy ( combined group ) using small-volume sclerosant .


The end-points of the study were rebleeding and recurrence of esophageal varices .


During a median follow-up period of @ mo , varices recurred in @ patient in the combined group as compared with @ patients in the EVL group ( P = @ ) .


Rebleeding occurred in @ patients in the EVL group as compared with @ patient in the combined group ( P = @ ) .


No patient died in the two groups .


No significant differences were observed between the two groups with respect to serious adverse events .


Intravariceal-mucosal sclerotherapy using small dose of sclerosant is more effective than EVL in decreasing the incidence of variceal recurrence for cirrhotic patients .


There is considerable interest in pharmacogenetic and molecular biomarkers .


Our aim was to evaluate the effects of enalapril/lercanidipine combination on some emerging biomarkers for cardiovascular risk stratification of hypertensive patients , such as lipoprotein ( a ) -LSB- Lp ( a ) -RSB- , soluble advanced glycation end products ( sRAGE ) , soluble CD@ ligand ( sCD@L ) and serum myeloperoxidase ( MPO ) .


Three hundred and forty-five patients were enrolled in this randomized , double-blind , clinical trial : @ hypertensive patients were randomized to enalapril @ mg , @ to lercanidipine @ mg and @ to enalapril/lercanidipine @/@ mg fixed combination .


We measures the following markers at baseline and after @ , @ , @ and @ months : blood pressure , fasting plasma glucose ( FPG ) , lipid profile , Lp ( a ) , sRAGE , sCD@L and MPO .


There was a decrease in blood pressure in all groups compared with baseline , even if , as expected , enalapril/lercanidipine combination was more effective in reducing blood pressure compared with the monotherapies .


No variations in lipid profile or FPG were recorded in any of the groups .


Lercanidipine , but not enalapril , improved Lp ( a ) levels compared with baseline .


The combination enalapril/lercanidipine improved it more than the single therapies .


All treatments increased sRAGE levels , and decreased sCD@L and MPO , with a better effect seen with the enalapril/lercanidipine combination compared with single monotherapies .


The combination enalapril/lercanidipine seems to be better than the single monotherapies in reducing not only blood pressure , but also the levels of some emerging biomarkers , potentially useful for cardiovascular risk stratification of hypertensive patients .


There is a paucity of literature on the use of honey in wound healing after oral and maxillofacial surgical procedures .


To evaluate the efficacy of the healing properties of Obudu honey in patients who developed wound dehiscence after segmental mandibular resections .


This was a prospective study of @ patients who had benign lesions of the mandible , and were treated by segmental mandibular resection , with the surgical wounds developing dehiscence .


The subjects were randomized into two treatment groups of A ( control , n = @ ) and B ( experimental , n = @ ) .


Unlike the control , the wounds in the experimental group were dressed in honey after debridement .


The ages of the patients ranged from @ to @ years with a mean age of @ @ years while the male : female ratio was @:@ .


There was no significant demographic difference about age ( P = @ ) and gender ( P = @ ) between the two groups .


The smaller the initial circumference of the surgical wound , the shorter the duration of healing and this was significant ( P = @ ) in either of the treatment groups .


Numerically , more healing was completed in the first @ weeks in subjects in the experimental group ( n = @ , @ % ) than the control ( n = @ , @ % ) .


However , the duration of healing between the subjects in the control and experimental groups at the end of @ weeks showed no significant difference ( P = @ ) .


Honey speeds up the healing of dehiscence wounds of resected mandible when used as dressing more than the control .


We aimed to evaluate the efficacy and safety of fully covered esophageal stent placement for preventing esophageal strictures after endoscopic submucosal dissection ( ESD ) .


Twenty-two patients with a mucosal defects that exceeded @ % of the circumference of the esophagus after ESD treatment for superficial esophageal squamous cell carcinomas were grouped according to the type of mucosal defect and randomized to undergo fully covered esophageal stent placement post-ESD ( group A , n = @ ) or no stent placement ( group B , n = @ ) .


In group A , the esophageal stents were removed @ weeks post-ESD .


Endoscopy was performed when patients reported dysphagia symptoms and at @ weeks post-ESD in patients without symptoms .


Savary-Gilliard dilators were used for bougie dilation in patients experiencing esophageal stricture in both groups , and we compared the rates of post-ESD strictures and the need for bougie dilation procedures .


The proportion of patients who developed a stricture was significantly lower in group A ( @ % , n = @ ) than in group B ( @ % , n = @ ) ( P < @ ) .


Moreover , the number of bougie dilation procedures was significantly lower in group A ( mean @ , range @-@ ) than in group B ( mean @ , range @-@ ) ( P < @ ) .


The two patients in group A who experienced stricture also had stent displacement .


Esophageal stents are a safe and effective method of preventing esophageal strictures in cases where > @ % of the circumference of the esophagus has mucosal defects after ESD treatment for early esophageal cancer .


Does culture in a closed system result in an increased number of good quality embryos ( GQE ) on Day @ compared with culture in a conventional system ?


Culture in a closed system up to @ days after microinjection results in similar embryo development and morphological quality compared with culture in a conventional incubation system .


Time-lapse imaging ( TLI ) incubators are rapidly being introduced into IVF laboratories worldwide , despite the lack of large prospective randomized trials demonstrating improvement in embryo development or pregnancy rates .


A randomized controlled trial including @ patients ( @ cycles ) was conducted between May @ and February @ .


After oocyte collection , randomization was carried out and all of a patients ' oocytes were allocated to culture in either a conventional incubator or a closed incubator system in proportion @:@ until embryo transfer on Day @ .


A total of @ oocytes were injected and cultured in the closed system , and @ in the standard incubator .


The primary end-point was the number of GQE in the two groups .


In total , @ patients undergoing their first IVF cycle using ICSI , where at least one oocyte was retrieved , were randomized in a university hospital setting .


Two hundred and forty patients were randomized for culture in a closed system and @ patients for culture in the conventional incubator system ( control group ) .


Embryo assessments and final morphological scoring before transfer and cryopreservation were carried out at the same time points for embryos cultured in the conventional incubator and in the closed system .


There was no significant difference in the mean SD number of GQEs between groups : @ @ for the closed system group and @ @ for the control group ( P = @ , difference @ , @ % confidence interval @ ; -@ ) .


No significant differences were found in the number of @-cell embryos , implantation - , pregnancy - or ongoing pregnancy rates .


A significantly higher miscarriage rate was found in the TLI group compared with the control group ( @ and @ % , P = @ ) .


Culture media , temperature and gas levels were similar in the open and closed incubator systems , but different culture dishes were used .


Culturing embryos for longer time period ( to the blastocyst stage ) may give different results .


Only ICSI patients were included , which may limit the generalizability of the results .


Finally , the number of GQEs on Day @ was used as a surrogate outcome for live birth .


The results are consistent with other , smaller randomized trials showing no difference in embryo quality when comparing culture in a conventional incubator with that of a closed TLI incubator system .


The European Randomised study of Screening for Prostate Cancer ( ERSPC ) has shown significant reductions in prostate cancer mortality after @ years and @ years of follow-up , but screening is controversial because of adverse events such as overdiagnosis .


We provide updated results of mortality from prostate cancer with follow-up to @ , with analyses truncated at @ , @ , and @ years .


ERSPC is a multicentre , randomised trial with a predefined centralised database , analysis plan , and core age group ( @-@ years ) , which assesses prostate-specific antigen ( PSA ) testing in eight European countries .


Eligible men aged @-@ years were identified from population registries and randomly assigned by computer generated random numbers to screening or no intervention ( control ) .


Investigators were masked to group allocation .


The primary outcome was prostate cancer mortality in the core age group .


Analysis was by intention to treat .


We did a secondary analysis that corrected for selection bias due to non-participation .


Only incidence and no mortality data at @ years ' follow-up are reported for the French centres .


This study is registered with Current Controlled Trials , number ISRCTN@ .


With data truncated at @ years of follow-up , @ prostate cancer cases were diagnosed in the intervention group and @ cases in the control group .


The rate ratio of prostate cancer incidence between the intervention and control groups was @ ( @ % CI @-@ ) after @ years ( @ -LSB- @-@ -RSB- including France ) , @ ( @-@ ) after @ years , and @ ( @-@ ) after @ years .


The rate ratio of prostate cancer mortality was @ ( @-@ ) after @ years , @ ( @-@ ) after @ years , and @ ( @-@ ) at @ years .


The absolute risk reduction of death from prostate cancer at @ years was @ per @ person-years or @ per @ men randomised , which is equivalent to one prostate cancer death averted per @ ( @ % CI @-@ ) men invited for screening or one per @ ( @-@ ) additional prostate cancer detected .


After adjustment for non-participation , the rate ratio of prostate cancer mortality in men screened was @ ( @ % CI @-@ ) .


In this update the ERSPC confirms a substantial reduction in prostate cancer mortality attributable to testing of PSA , with a substantially increased absolute effect at @ years compared with findings after @ and @ years .


Despite our findings , further quantification of harms and their reduction are still considered a prerequisite for the introduction of populated-based screening .


This secondary analysis investigated the impact of @ sessions of Seeking Safety ( SS ) on reducing posttraumatic stress disorder ( PTSD ) symptoms in a sample of dually diagnosed women with physical disabilities versus nondisabled ( ND ) women .


SS is an evidence-based and widely implemented manualized therapy for PTSD and/or substance use disorder .


It is a present-focused model that promotes coping skills and psychoeducation .


As part of the National Institute on Drug Abuse Clinical Trials Network ( NIDA CTN ) , @ participants with current PTSD and substance use disorder ( SUD ) were randomly assigned to partial-dose SS or Women 's Health Education ( WHE ) group therapy conducted in community-based substance abuse treatment programs .


The women were categorized as participants with disabilities ( PWD ; n = @ ) or ND ( n = @ ) based on the question , `` Do you receive a pension for a physical disability ? ''


PTSD was assessed on the Clinician-Administered PTSD Scale ( CAPS ) at baseline and follow-ups after treatment ( @ week , @ months , @ months , and @ months ) .


PWD experienced sustained reductions in PTSD symptoms when treated with SS but not WHE .


Indeed , PTSD symptoms of PWD in WHE returned to baseline levels of severity by @-month follow-up .


This pattern of results was not observed among ND women , who sustained improvements on PTSD in both treatment conditions .


These results suggest strong potential for using SS to treat PTSD among women with physical disabilities , and speak to the genuine need to address trauma and PTSD more directly with PWD .


Our results are also consistent with other findings from the NIDA CTN trial , in which virtually all significant results evidenced SS outperforming WHE .


To evaluate the effect of sevoflurane or ketamine on the corrected QT ( QTc ) interval and the interval from the peak to the end of the T wave ( Tp-e ) during electroconvulsive therapy ( ECT ) in patients with major depression .


This prospective , randomized , double-blinded study included @ patients that were randomly allocated to receive sevoflurane ( group S ) or ketamine ( group K ) for ECT session .


Group S patients received @ % sevoflurane for anesthesia induction , which was maintained at @-@ % until delivery of the electrical stimulus .


Group K patients received a bolus of ketamine ( @mg/kg ) .


The mean arterial pressure ( MAP ) and heart rate ( HR ) and the electrocardiogram ( ECG ) were recorded before ( T@ ) and after induction of anesthesia ( T@ ) and @ , @ , @ , and @min after the electrical stimuli ended ( T@ , T@ , T@ , and T@ , respectively ) .


In both groups , the QTc interval was significantly longer at T@ , T@ , T@ , and T@ than at baseline .


The QTc interval was longer at T@ , T@ , and T@ in group S compared to that in group K , the Tp-e interval was significantly longer at T@ in group K both baseline and group S.


The HR in group S was increased at T@ compared with group K. MAP was significantly higher after induction of anesthesia in group K compared to those in group S at all time points .


Although group S showed a prolonged QTc interval after ECT compared to group K , the Tp-e interval in both groups was not significantly affected clinically .


Sevoflurane blunted MAP and peak HR .


Fresh red cells may improve outcomes in critically ill patients by enhancing oxygen delivery while minimizing the risks of toxic effects from cellular changes and the accumulation of bioactive materials in blood components during prolonged storage .


In this multicenter , randomized , blinded trial , we assigned critically ill adults to receive either red cells that had been stored for less than @ days or standard-issue red cells ( the oldest compatible units available in the blood bank ) .


The primary outcome measure was @-day mortality .


Between March @ and May @ , at @ centers in Canada and Europe , @ patients were assigned to receive fresh red cells ( fresh-blood group ) and @ patients were assigned to receive standard-issue red cells ( standard-blood group ) .


Red cells were stored a mean ( SD ) of @ days in the fresh-blood group as compared with @ days in the standard-blood group ( P < @ ) .


At @ days , @ patients ( @ % ) in the fresh-blood group and @ patients ( @ % ) in the standard-blood group had died ( absolute risk difference , @ percentage points ; @ % confidence interval -LSB- CI -RSB- , -@ to @ ) .


In the survival analysis , the hazard ratio for death in the fresh-blood group , as compared with the standard-blood group , was @ ( @ % CI , @ to @ ; P = @ ) .


There were no significant between-group differences in any of the secondary outcomes ( major illnesses ; duration of respiratory , hemodynamic , or renal support ; length of stay in the hospital ; and transfusion reactions ) or in the subgroup analyses .


Transfusion of fresh red cells , as compared with standard-issue red cells , did not decrease the @-day mortality among critically ill adults .


( Funded by the Canadian Institutes of Health Research and others ; Current Controlled Trials number , ISRCTN@ . )


To determine whether the benefits of sentinel node based management ( SNBM ) over routine axillary clearance ( RAC ) at @ year persisted to @ years of follow-up .


A total of @,@ women with clinically node-negative breast cancer were randomly assigned to the SNBM or RAC group .


Upper limb volume , symptoms , and function were assessed at @ , @ , @ , @ , and @ months after surgery objectively with upper limb measurements by clinicians and subjectively by patients ' using validated self-rating scales .


Upper limb volume increased in both groups over the first @ years and differed between the two groups all time points beyond @ month ( P < @ ) but then plateaued .


Upper limb swelling was no worse in women who had axillary clearance as a two-stage procedure than in women assigned RAC as a one-stage procedure .


Upper limb volume had increased @ % or more in @ % at @ months and @ % at @ years in those assigned RAC versus @ and @ % in those assigned SNBM .


Reductions in upper limb movement were also greater , with RAC than SNBM over @ months , but improved and were similar in the two groups from @ to @ years .


Subjective ratings of upper limb swelling , symptoms , dysfunction , and disability over @ years were worse in the RAC group .


Upper limb swelling at @ years was rated severe by few women ( @ % ) but was rated as moderate by @ % in the RAC group and @ % in the SNBM group ( P < @ ) .


The benefits of SNBM over RAC persist @ years after surgery .


Recent evidence suggests thyroidectomy ( Tx ) followed by radioiodine remnant ablation to be beneficial to Graves ' orbitopathy ( GO ) patients .


The aim of the study was to evaluate the effect of ( @ ) I thyroid ablation after recombinant human TSH stimulation in patients with moderate-to-severe GO .


The study was prospective , randomized , and single-blind , and it included @ consecutive patients with moderate-to-severe GO randomized into : @ ) a Tx-radioactive iodine ( RAI ) group ( @ subjects who underwent total-Tx and ( @ ) I ablation after recombinant human TSH stimulation ) ; and @ ) a Tx group ( @ subjects who underwent total-Tx alone ) .


The overall GO outcome @ months after Tx/radioiodine ablation was the main measure .


GO evaluation at the end of iv glucocorticoids showed eye disease to be improved in @ % of the Tx-RAI group and @ % of the Tx group patients .


At @ and @ months , no further changes in the GO outcome could be observed in the Tx-RAI group .


Conversely , five patients from the Tx group exhibited a deterioration in GO .


At @ months , GO was found to be improved in @ % of the Tx-RAI and @ % of the Tx group patients , the latter being found to be stable ( @ % ) or worse ( @ % ) than at baseline evaluation .


At @ months , GO was found to be inactive in a significantly higher percentage of patients in the Tx-RAI than in the Tx group ( @ vs @ % ; P < @ ) .


Postoperative radioiodine ablation proved more effective than Tx alone in inducing earlier and steadier GO improvement in patients with moderate-to-severe GO treated with iv glucocorticoids over a @-month follow-up period .


Strains of @ distinct influenza B lineages ( Victoria and Yamagata ) have cocirculated in the United States for over a decade , but trivalent influenza vaccines ( TIVs ) contain only @ B-lineage strain .


Each season , some or most influenza B disease is caused by the B lineage not represented in that season 's TIV .


Quadrivalent influenza vaccines ( QIVs ) containing a strain from each B lineage should resolve this problem .


This was a Phase III , randomized , multicenter trial in the United States among children @ months to < @ years of age to evaluate the safety and immunogenicity of inactivated QIV compared with inactivated control TIVs containing opposite B-lineage strains .


Participants were randomized at a ratio of approximately @:@:@ to receive QIV , TIV containing a Victoria-lineage B strain or TIV containing a Yamagata-lineage B strain .


Sera were collected pre - and @-days post-final vaccination and safety was assessed for @ months after the last injection .


A total of @ participants were enrolled .


QIV induced noninferior antibody responses to all A strains and corresponding B strains compared with the control TIVs and superior antibody responses to the noncorresponding B strain in each TIV .


Rates of solicited reactions and unsolicited and serious adverse events were similar in all groups .


This study demonstrated that QIV is safe and immunogenic among children @ months to < @ years of age .


These findings , along with data from @ other studies of this QIV in adults , suggest that QIV should offer protection against both B lineages with a safety profile similar to TIV across all ages .


The HPTN @ trial confirmed that antiretroviral therapy ( ART ) can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples .


Here , we present the mathematical modeling used to inform the design and monitoring of a new trial aiming to test whether widespread provision of ART is feasible and can substantially reduce population-level HIV incidence .


The HPTN @ ( PopART ) trial is a three-arm cluster-randomized trial of @ large population clusters in Zambia and South Africa , starting in @ .


A combination prevention package including home-based voluntary testing and counseling , and ART for HIV positive individuals , will be delivered in arms A and B , with ART offered universally in arm A and according to national guidelines in arm B. Arm C will be the control arm .


The primary endpoint is the cumulative three-year HIV incidence .


We developed a mathematical model of heterosexual HIV transmission , informed by recent data on HIV-@ natural history .


We focused on realistically modeling the intervention package .


Parameters were calibrated to data previously collected in these communities and national surveillance data .


We predict that , if targets are reached , HIV incidence over three years will drop by > @ % in arm A and > @ % in arm B , relative to arm C.


The considerable uncertainty in the predicted reduction in incidence justifies the need for a trial .


The main drivers of this uncertainty are possible community-level behavioral changes associated with the intervention , uptake of testing and treatment , as well as ART retention and adherence .


The HPTN @ ( PopART ) trial intervention could reduce HIV population-level incidence by > @ % over three years .


This intervention could serve as a paradigm for national or supra-national implementation .


Our analysis highlights the role mathematical modeling can play in trial development and monitoring , and more widely in evaluating the impact of treatment as prevention .


Patients with Kawasaki disease ( KD ) are at risk for developing coronary artery lesions , but the association of noncoronary changes such as mitral regurgitation ( MR ) and/or pericardial effusion ( PE ) with cardiac mechanics in the acute phase of KD has not been previously described .


The aim of this study was to test the hypothesis that these noncoronary markers for carditis are associated with abnormalities in strain ( ) and strain rate ( SR ) in patients with MR or PE not appreciated by conventional echocardiography .


Longitudinal and circumferential and SR analyses were retrospectively performed on patients with KD .


Patients with and without MR or PE were compared .


Strain values were also compared between patients with and without coronary artery lesions .


Values for ejection fraction , shortening fraction , and clinical laboratory parameters were correlated with MR or PE .


Follow-up echocardiographic outcomes were recorded at the first encounter after initial diagnosis .


Follow-up and SR data were also obtained in the group with MR or PE and altered ventricular mechanics at diagnosis .


Of the @ patients reviewed , @ had appropriate image quality for either longitudinal and SR or circumferential and SR analysis .


Twenty-eight patients ( @ % ) had either MR or PE .


Longitudinal and SR were significantly decreased in patients with MR or PE compared with patients without MR or PE ( : -@ % vs -@ % , P = @ ; SR : -@ vs -@ sec ( -@ ) , P = @ ) .


No significant difference in longitudinal or SR was noted between patients with and without coronary artery lesions ( : -@ % vs -@ % , P = @ ; SR : -@ vs -@ sec ( -@ ) , P = @ ) .


In the group with abnormal coronary arteries , presence of MR or PE was correlated with decreased longitudinal ( -@ % vs -@ % , P = @ ) , without a significant difference in longitudinal SR ( -@ vs -@ sec ( -@ ) , P = @ ) .


At approximately @-week follow-up ( @ days ) , longitudinal and SR for the group with MR or PE had increased significantly compared with diagnosis ( : -@ % vs -@ % , P = @ ; SR : -@ vs -@ sec ( -@ ) , P = @ ) , coincident with resolution of MR or PE .


In both groups , erythrocyte sedimentation rate and C-reactive protein were elevated ( @ mm/h vs @ mm/h -LSB- P = @ -RSB- and @ vs @ mg/dL -LSB- P = @ -RSB- ) , but only modest correlations were noted between longitudinal and elevated erythrocyte sedimentation rate ( r = @ , P = @ ; confidence interval , @-@ @ ) and C-reactive protein ( r = @ , P = @ ; confidence interval , @-@ @ ) in patients with MR or PE .


Shortening fraction and ejection fraction were within the normal range in both groups .


Patients presenting with KD with MR or PE at diagnosis are likely to have altered ventricular mechanics compared with patients with KD without MR or PE despite normal conventional echocardiographic measures of function .


There is no significant difference in ventricular mechanics when comparing patients with KD with coronary ectasia or aneurysms and those without coronary lesions .


Presence of abnormal in patients with KD with altered ventricular mechanics correlates modestly with laboratory inflammatory markers .


Peak systolic longitudinal and SR increased significantly at @-week follow-up compared with initial diagnosis , coincident with resolution of MR or PE .


Loss of lean body mass ( LBM ) is a common occurrence after treatment for breast cancer and is related to deleterious metabolic health outcomes -LSB- Clin Oncol , @ ( @ ) :@ -@ , @ ; Appl Physiol Nutr Metab , @ ( @ ) :@ -@ , @ -RSB- .


The aim of this research is to determine the effectiveness of long chain omega-@ fatty acids ( LCn-@s ) and exercise training alone , or in combination , in addressing LBM loss in breast cancer survivors .


A total of @ women who have completed treatment for breast cancer in the last @ months , with a Body Mass Index ( BMI ) of @ to @ kg/m@ , will be randomly assigned to one of @ groups : @g/d LCn-@s ( N-@ ) , a @-week nutrition and exercise education program plus olive oil ( P-LC ) or the education program plus LCn-@s ( EX+N -@ ) .


Participants randomised to the education groups will be blinded to treatment , and will receive either olive oil placebo ( OO+N -@ ) or LCn-@ provision , while the N-@ group will be open label .


The education program includes nine @-@ min sessions over @ weeks that will involve breast cancer specific healthy eating advice , plus a supervised exercise session run as a resistance exercise circuit .


They will also be advised to conduct the resistance training and aerobic training @ to @ days per week collectively .


Outcome measures will be taken at baseline , @-weeks and @-weeks .


The primary outcome is % change in LBM as measured by the air displacement plethysmograhy .


Secondary outcomes include quality of life ( FACT-B + @ ) and inflammation ( C-Reactive protein : CRP ) .


Additional measures taken will be erythrocyte fatty acid analysis , fatigue , physical activity , menopausal symptoms , dietary intake , joint pain and function indices .


This research will provide the first insight into the efficacy of LCn-@s alone or in combination with exercise in breast cancer survivors with regards to LBM and quality of life .


In addition , this study is designed to improve evidence-based dietetic practice , and how specific dietary prescription may link with appropriate exercise interventions .


To determine if training with a chicken wing model improves performance of endoscopic endonasal surgery ( EES ) with microvascular dissection .


Randomized experimental study .


A single-blinded randomized clinical trial of trainees with various levels of endoscopic experience was conducted to determine if prior training on a nonhuman model augments endoscopic skill and efficiency in a surrogate model for live surgery .


Medical students , residents , and fellows were randomized to two groups : a control group that performed an endoscopic transantral internal maxillary artery dissection on a silicone-injected anatomical specimen , and an interventional group that underwent microvascular dissection training on a chicken wing model prior to performing the anatomic dissection on the cadaver specimen .


Time to completion and quality of dissection were measured .


A Mann-Whitney test demonstrated a significant improvement in time and quality outcomes respectively across all interventional groups , with the greatest improvements seen in participants with less endoscopic experience : medical students ( P = @ , P = @ ) , residents and fellows ( P = @ , P = @ ) .


Prior training on the chicken wing model improves surgical performance in a surrogate model for live EES .


Intranasal corticosteroids are the mainstay of allergic rhinitis ( AR ) treatment .


Their potential to suppress the hypothalamic-pituitary-adrenal axis should be evaluated , especially after long-term daily use in children .


To evaluate the effects of treatment with non-aqueous beclomethasone dipropionate ( BDP ) nasal aerosol on hypothalamic-pituitary-adrenal axis function in children with perennial AR .


In this double-blinded , placebo-controlled , parallel-group study , patients ( @-@ years old ) with perennial AR were randomized ( @:@ ) to BDP nasal aerosol at @ g/day ( n = @ ) or placebo ( n = @ ) .


The primary end point was change from baseline in @-hour serum cortisol ( SC ) weighted mean for BDP nasal aerosol and placebo after @ weeks of treatment , which was analyzed in the per-protocol population .


The per-protocol population included @ patients ( BDP nasal aerosol , n = @ ; placebo , n = @ ) .


Baseline geometric mean SC weighted mean values were similar in the @-g/day BDP nasal aerosol and placebo groups ( @ and @ g/dL , respectively ) .


After @ weeks ' treatment , geometric mean values were @ and @ g/dL , respectively , with no decrease from baseline in either group .


Geometric mean SC ratio ofBDP nasal aerosol at @ g/day to placebo was @ ( @ % confidence interval @-@ @ ) , indicating predefined noninferiority .


SC concentration-time profiles were similar for the placebo and @-g/day BDP nasal aerosol groups at baseline and week @ .


BDP nasal aerosol at @ g/day was generally well tolerated .


In pediatric patients with perennial AR , @-hour SC profiles were comparable for BDP nasal aerosol and placebo , indicating that once-daily BDP nasal aerosol treatment did not significantly affect hypothalamic-pituitary-adrenal axis function .


Twenty vertically HIV-infected children , @-@ years of age , with stable viral load control and CD@ + values above @ cells/mm ( @ ) .


Ten subjects continued their ongoing antiretroviral treatment ( ART , Group A ) and @ were immunized with a HIV-DNA vaccine in addition to their previous therapy ( ART and vaccine , Group B ) .


The genetic vaccine represented HIV-@ subtypes A , B and C , encoded Env , Rev , Gag and RT and had no additional adjuvant .


Immunizations took place at weeks @ , @ and @ , with a boosting dose at week @ .


Monitoring was performed until week @ and extended to week @ .


Safety data showed good tolerance of the vaccine .


Adherence to ART remained high and persistent during the study and did not differ significantly between controls and vaccinees .


Neither group experienced either virological failure or a decline of CD@ + counts from baseline .


Higher HIV-specific cellular immune responses were noted transiently to Gag but not to other components of the vaccine .


Lymphoproliferative responses to a virion antigen HIV-@ MN were higher in the vaccinees than in the controls ( p = @ ) , whereas differences in reactivity to clade-specific Gag p@ , RT or Env did not reach significance .


Compared to baseline , the percentage of HIV-specific CD@ + lymphocytes releasing perforin in the Group B was higher after the vaccination schedule had been completed ( p = @ ) .


No increased CD@ + perforin levels were observed in control Group A.


The present study demonstrates the feasibility , safety and moderate immunogenicity of genetic vaccination in vertically HIV-infected children , paving the way for amplified immunotherapeutic approaches in the pediatric population .


Central venous catheters for maintenance hemodialysis ( HD ) are designed to attain the required dialysis dose through sustained high blood flow rates ( BFR ) .


The authors studied the immediate and long-term performance and complications of two twin-catheter systems , the Tesio catheter ( TC ) and the LifeCath Twin ( LC ) , to inform clinical practice .


This single-center randomized controlled parallel-group trial allocated @ incident patients ( @:@ ) to receive either a TC ( MedComp ) or LC ( Vygon ) .


Patients were dialyzed to target BFR @ mL/min and followed up for @ months .


The primary outcome was achievement of target BFR during the first HD session .


Secondary outcomes included thrombotic dysfunction , displacement and catheter-related infection .


Catheter dysfunction was defined by a BFR @ mL/min .


More LCs reached the primary endpoint ( @ % vs. @ % , p = @ ) delivering a higher BFR ( mean @ vs. @ mL/min , p < @ ) .


Significant differences in BFR persisted until the fourth dialysis session .


Rates of catheter-related bacteremia ( @ vs. @ / @,@ catheter days , p = @ ) and exit site infection were similar between groups ( @ vs. @ / @,@ catheter days , p = @ ) .


Overall rates of catheter dysfunction were @ / @,@ catheter days ( @ % CI @-@ @ ) , with no differences in thrombolytic lock use although the LC group required more thrombolytic infusions ( @ vs. @ , p = @ ) .


The LC can deliver greater BFRs in the first three HD sessions following insertion although this did not translate into differences in performance , dialysis adequacy or complication rates with long-term use .


Both catheter types can consistently deliver high BFRs over an extended period of time .


Due to the steady increase of substance-dependent pregnant women the neonatal abstinence syndrome has become an increasingly important issue in neonatology .


The present study investigates site-specific differences of detailed symptoms and treatment of neonatal abstinence syndrome within the context of an international multicenter clinical trial .


Site specific neonatal data analyses from a prospective randomized , double-blind , double-dummy clinical trial ( MOTHER study ) was performed .


A standardized NAS rating and treatment protocol was applied , while non-pharmacological care of NAS symptoms differed across the sites .


Urban US neonates exhibited most neurological symptoms ( p < @ ) while in Europe autonomous , respiratory and gastrointestinal symptoms were found significantly more often compared to urban and/or rural US ( p < @ ) .


Methadone produced significantly greater scores than buprenorphine in neurological , behavioural and respiratory symptoms regardless of the sites ( ps < @ ) .


NAS treatment rates in all site clusters were similar for methadone-exposed neonates , while in Europe significantly more buprenorphine-exposed neonates were treated ( p = @ ) than in US site clusters .


Urban US neonates had significantly higher NAS scores ( p < @ ) compared to rural US and European neonates , and needed significantly higher morphine doses ( p < @ ) with longer treatment duration .


Birth weight , length and head circumference did not differ significantly among the site clusters , but APGAR scores were significantly higher in European ( p < @ ) neonates .


In addition to intrauterine medication exposure other aspects such as different addiction severity of the mothers , different treatment modalities including rooming-in as well as the frequency of NAS ratings may be influencing the course of NAS .


To determine the degree of dietary adherence or change in eating patterns , and demographic , psychosocial and study characteristics associated with adherence , in the Comparing Healthy Options in Cooking and Eating ( CHOICE ) Study .


Randomized controlled trial where women were randomized to one of three eating patterns : ( i ) Whole Foods , plant-based , macrobiotic-style ( n @ ) ; and Moderate Fat with ( ii ) , and without ( iii ) , @ g of ground flaxseed added daily , which were combined ( n @ ) .


A year-long intervention based on social cognitive theory , consisting of twenty-four class sessions involving hands-on cooking classes and behavioural sessions .


Monthly @ h food recalls were obtained and a psychosocial questionnaire was administered at baseline , @ and @ months .


Healthy , free-living , postmenopausal women .


A non-adherence score measuring all food servings out-of-compliance with eating pattern recommendations was specifically designed for the present study .


Non-adherence scores decreased significantly ( P < @ ) in both groups to about @ % during the adoption phase ( first @ months ) and remained so during the @-month maintenance period .


Class attendance of the Moderate Fat group showed a trend towards significance as a predictor of adherence ( P = @ ) .


None of the other predictors ( e.g. demographic and psychosocial factors ) in a longitudinal regression model were significant .


Postmenopausal women were able to adopt and maintain significant changes in their eating patterns , including those on a demanding , near-vegetarian eating plan , suggesting that behavioural interventions with a healthy free-living population can be effective .


The non-adherence score developed for the study provides an example of a means for evaluating eating pattern adherence to a dietary intervention .


Chronic hepatocellular damage is closely associated with hepatic fibrosis and fatal complication in most liver diseases .


The aim of this study is to compare the efficacy and safety of biphenyl dimethyl dicarboxylate ( DDB ) and ursodeoxycholic acid ( UDCA ) in patients with abnormal ALT .


One-hundred thirty-five patients with elevated ALT were randomized to receive either @ mg/day of DDB or @ mg/day of UDCA for @ weeks in @ referral hospitals .


Ninety-three ( @ % ) patients had non-alcoholic steatohepatitits , @ ( @ % ) had alcoholic hepatitis , and @ ( @ % ) had chronic hepatitis .


The primary end point was the rate of ALT normalization at week @ .


The secondary endpoints were changes in AST , liver stiffness , and the incidence of adverse events .


A total of @ patients completed @ weeks of therapy .


ALT normalization at week @ was observed in @ ( @ % ) patients in DDB group and @ ( @ % ) in UDCA group ( p < @ ) .


Higher mean reduction of ALT levels from baseline to @ weeks was seen in DDB group compared with UDCA group ( -@ % vs. -@ % , p < @ ) .


Normalization of AST level ( p = @ ) and change in the liver stiffness ( p = @ ) were not significantly different between the two groups .


Severe adverse drug reaction occurred in @ patient in DDB group but the subject continued therapy during the study period .


DDB was not inferior to UDCA for normalizing ALT level .


Furthermore it was safe and well tolerated by patients with abnormal ALT .


Diabetes mellitus is a healthcare burden in India .


Seventy-four percent of India 's population lives in rural areas with limited access to healthcare resources .


Telemedicine can play a big role in screening people with diabetes at grassroots level .


In the telescreening model , single field @-degree photographs are used for detecting diabetic retinopathy .


The American Academy of Ophthalmology does not recommends single-field fundus photography as an adequate substitute for a comprehensive ophthalmic examination because it may lead to a higher rate of underdiagnosis .


We conducted a telescreening project using single-field fundus photography to determine its accuracy compared to the traditional camp-based screenings .


In this project we compared the prevalence of diabetic retinopathy between an ophthalmologist-based and an ophthalmologist-led model on two different samples of people self-reporting with diabetes in rural South India .


Between @ and @ in rural South India , @ people with diabetes mellitus underwent ophthalmologist-based diabetic retinopathy screening and @ people with diabetes underwent ophthalmologist-led ( telescreening ) diabetic retinopathy screening .


The two population groups were randomly separated .


In the ophthalmologist-based program , a trained retina specialist travels along with the camp team and screens patients at the camp site for diabetic retinopathy .


In the ophthalmologist-led program ( telescreening ) , fundus photographs are transmitted to the base hospital for further evaluation and grading .


A total of @ people ( @ % ) were diagnosed to have diabetic retinopathy in the ophthalmologist-based model , and @ people ( @ % ) in the ophthalmologist-led model p < @ ) .


More sight-threatening retinopathies were found in the ophthalmologist-led model than in the ophthalmologist-based model ( @ % vs. @ % ) .


The ophthalmologist-led ( telescreening ) model did not underestimate the prevalence of diabetic retinopathy .


Therefore , because it obviates the need for travel by an ophthalmologist , it is a good method for diabetic retinopathy screening in rural areas of India .


Clinical trials traditionally use time-to-first-event analysis embedded within the composite endpoint of cardiovascular death ( CVD ) , myocardial infarction ( MI ) , or stroke .


However , many patients have > @ event , and this approach may not reflect overall experience .


We addressed this by analyzing all cardiovascular events in TRACER .


TRACER randomized @ @ patients with non-ST-segment elevation acute coronary syndromes to placebo or to protease-activated receptor @ antagonist vorapaxar with a median follow-up of @ days ( interquartile range , @ to @ ) .


Analysis of vorapaxar 's effect on recurrent CVD , MI , or stroke was prespecified using the Wei , Lin , and Weissfeld approach .


Vorapaxar did not reduce the first occurrence of the primary endpoint of CVD , MI , stroke , revascularization , or rehospitalization for recurrent ischemia , but reduced the secondary composite endpoint of CVD , MI , or stroke ( @ % vorapaxar vs. @ % placebo ; hazard ratio -LSB- HR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ; number needed to treat -LSB- NNT -RSB- , @ ) .


Recurrent secondary events occurred in @ % of patients .


Vorapaxar reduced overall occurrences of ischemic events , first and subsequent ( HR , @ ; @ % CI , @ to @ ; P = @ ; NNT , @ ) .


Also , there was a trend indicating that vorapaxar reduced the expanded endpoint , including revascularization and rehospitalization for recurrent ischemia ( HR , @ ; @ % CI , @ to @ ; P = @ ) .


Vorapaxar increased overall occurrences of moderate and severe Global Use of Strategies to Open Occluded Coronary Arteries bleeding ( HR , @ ; @ % CI , @ to @ ; P < @ ) and Thrombolysis in Myocardial Infarction clinically significant bleeding ( HR , @ ; @ % CI , @ to @ ; P < @ ) .


Vorapaxar reduced overall occurrences of ischemic events , but increased bleeding .


These exploratory findings broaden our understanding of vorapaxar 's potential and expand our understanding of the value of capturing recurrent events .


Application of the capsaicin @ % patch is associated with treatment-related discomfort .


Consequently , pretreatment for @min with anaesthetic cream is recommended ; however , this may be uncomfortable and time consuming .


We conducted a multicentre , randomized ( @:@ ) , assessor-blinded study in patients with peripheral neuropathic pain to assess tolerability of the capsaicin patch following topical lidocaine ( @ % ) or oral tramadol ( @mg ) pretreatment .


The primary endpoint was the proportion of patients tolerating capsaicin patch application ( ability to receive @ % of a @-min application ) .


Numeric Pain Rating Scale ( NPRS ) scores were assessed before , during and after treatment .


Overall , @ patients were included ( @ per arm ) .


The capsaicin patch was tolerated by @ patients .


Tolerability of the capsaicin patch was similar following pretreatment with lidocaine and tramadol .


Following patch application , pain levels increased up to @min ( change from baseline of @ for lidocaine and @ for tramadol ) .


After patch removal , tramadol-treated patients experienced greater pain relief up to the end of day @ ; in the evening , mean changes in NPRS scores from baseline were @ for lidocaine and -@ for tramadol .


Proportions of patients reporting increases of @ NPRS points or > @ % from baseline at one or more time point ( s ) on the day of treatment were similar between arms .


Adverse event incidence was comparable between arms .


Capsaicin @ % patch tolerability was similar in the two arms , with comparable results for most secondary endpoints .


Tramadol given @min before patch application should be considered as an alternative pretreatment option in patients receiving capsaicin patch treatment .


To observe the clinical efficacy of transcutaneous acupoint electrical stimulation ( TAES ) combined intravenous injection and/or Neiguan ( P@ ) injection with droperidol in preventing and treating post-operative nausea and vomiting ( PONV ) after thyroid tumor surgery .


Recruited were @ female patients who underwent selective thyroid tumor surgery were randomly assigned to the control group , the TAES group , the IV group ( intravenous injection of droperidol ) , and the P@ group -LSB- Neiguan point ( P@ ) injection of droperidol -RSB- , respectively , @ cases in each group .


Thirty min before anesthesia induction , @ mL @ % normal saline injection was intravenously injected to those in the control group .


Patients in the TAES group received TEAS at bilateral P@ points .


@ mg ( @ mL ) droperidol added in @ mL @ normal saline was intravenously injected to those in the IV group and injected at bilateral P@ points of those in the P@ group .


The occurrence and severity of PONV were observed within @ - @ h and within @ - @ h after operation in each group .


Compared with the control group , the incidence and the severity of PONV within @ - @ h and within @ - @ h after thyroid surgery were significantly reduced in the three treatment groups ( P < @ ) .


There was no statistical difference in the incidence or the severity of PONV among the TAES , IV and P@ groups ( P > @ ) .


TEAS at P@ could dramatically reduce the occurrence and the severity of PONV after thyroid tumor surgery .


Besides , it got equivalent effect to that by intravenous injecting droperidol or by injecting droperidol at P@ .


To reevaluate the role of the antispasmodic drug drotaverine in shortening the length of the active first stage of labor among nulliparous women .


In a randomized , double-blind , placebo-controlled trial , @ young nulliparous women admitted to Ain-shams University Maternity Hospital , Cairo , Egypt , in spontaneous labor were initially enrolled between May and December @ .


Drotaverine hydrochloride ( @mg ) or placebo was given at the start of the active phase of labor and then repeated every @hours ( maximum @ doses ) .


All participants were consistently managed in accordance with the local institutional intrapartum protocol .


The primary outcome was the rate of cervical dilation .


After excluding women who delivered by cesarean , data were analyzed from @ women .


There was a significant difference in post-treatment labor pain scores , duration of the active phase of labor , and rate of cervical dilatation between the @ groups ( P < @ for all ) .


There was no difference in maternal adverse effects .


Kaplan-Meier survival analysis showed a greater probability of faster delivery among patients treated by drotaverine hydrochloride ( log rank test ; P < @ ) .


Drotaverine hydrochloride was used effectively and safely to shorten the duration of the first stage of labor among nulliparous women with active spontaneous labor .


ClinicalTrials.gov : NCT@ .


Relative efficacy and toxicity of cyclophosphamide compared with ifosfamide are debatable .


The Euro-EWING@-R@ trial asked whether cyclophosphamide may replace ifosfamide in combination with vincristine and dactinomycin ( vincristine , dactinomycin , and cyclophosphamide -LSB- VAC -RSB- v vincristine , dactinomycin , and ifosfamide -LSB- VAI -RSB- ) after an intensive induction chemotherapy containing vincristine , ifosfamide , doxorubicin , and etoposide ( VIDE ) in standard-risk localized disease ( NCT@ ) .


Standard-risk Ewing sarcomas were localized tumors with either a good histologic response to chemotherapy ( < @ % cells ) or small tumors ( < @ mL ) resected at diagnosis or receiving radiotherapy alone as local treatment .


Patients entered the trial after six VIDE +@ VAI courses .


Allocated treatment was either @ VAC courses with @ g/m ( @ ) of cyclophosphamide or seven VAI-courses with @ g/m ( @ ) ifosfamide .


The limit of noninferiority was set at -@ % for the @-year event-free survival rate ( EFS ) , equivalent to @ in terms of the hazard ratio of event ( HR ( event ) ) .


This large international trial recruited @ patients between February @ and March @ ( n = @ receiving VAC and n = @ receiving VAI ) .


With a median follow-up of @ years , the @-year EFSs were @ % and @ % , respectively , the @-year EFS difference was -@ % ( @ % CI , -@ to @ % ) , the HR ( event ) was @ ( @ % CI , @ to @ ) , and the HR ( death ) was @ ( @ % CI , @ to @ ; intention-to-treat ) .


The HR ( event ) was @ ( @ % CI , @ to @ ) on the per-protocol population .


Major treatment modifications were significantly less frequent in the VAC arm ( < @ % ) than in the VAI arm ( @ % ) , mainly resulting from toxicity .


Patients experienced more frequent thrombocytopenia in the VAC arm ( @ % v @ % ) but fewer grade @ to @ acute tubular toxicities ( @ % v @ % ) .


Cyclophosphamide may be able to replace ifosfamide in consolidation treatment of standard-risk Ewing sarcoma .


However , some uncertainty surrounding the noninferiority of VAC compared with VAI remains at this stage .


The ongoing comparative evaluation of long-term renal and gonadal toxicity is crucial to decisions regarding future patients .


To compare the use of the @nm diode laser with conventional surgery in the management of soft tissue mucogingival problems associated with orthodontic treatment .


Orthodontic patients requiring different soft tissue surgical procedures were randomly assigned to receive conventional surgery or soft tissue diode laser , ( wavelength @ nm ) .


Parameters documented include the type of anaesthesia used , intra and post operative pain , bleeding , the use of scalpel and sutures .


The chi-squared test was used to test for significance at @ % confidence level .


Probability values ( p-values ) less than @ were regarded as significant .


Only @ ( @ % ) of the procedures carried out with the soft tissue laser required infiltration anaesthesia compared to @ ( @ % ) with conventional surgery and this was significant ( P < @ ) .


Post operative pain was significantly reduced in all cases treated with the diode laser ( P < @ ) .


There was also a significant difference ( P < @ ) in post operative bleeding in all cases treated with the diode laser .


No sutures were used in all soft tissue cases managed with the diode laser and this was significant ( P < @ ) .


There was no statistically significant difference in treatment time in the use of the laser compared with conventional surgery .


Orthodontic patients treated with the diode laser required less infiltration anaesthesia , had reduced bleeding during and after surgery , rapid postoperative haemostasis , elimination of the need for sutures and an improved postoperative comfort and healing .


Recent data suggest that n-@ PUFA exert beneficial effects on endothelial progenitor cell ( EPC ) biology .


We sought to investigate whether these effects might be mediated by enhanced EPC in vitro function and/or in vivo bioavailability .


CACs and late-outgrowth EPCs were isolated from peripheral blood mononuclear cells obtained from @ donor buffy-coats .


The effect of n-@ PUFA ( EPA : DHA = @:@ ; @ M EPA plus @ M DHA ) was tested on CAC/EPC viability , function ( tube-formation ) and pro-inflammatory molecule expression .


Circulating EPC ( cells positive for CD@ , CD@ and kinase insert domain receptor - KDR cell-surface antigens by flow cytometry ) number was evaluated in @ healthy subjects ( @ F/@ M , @ @ years ) , randomized to receive @ mackerel or sardine portions per week for @ weeks followed by a @ week free-diet period .


N-@ PUFA improved CAC and late-outgrowth EPC viability ( p < @ ) and the capacity to form tube-like structures in CACs ( +@ % ; p < @ ) and late-outgrowth EPCs ( +@ % ; p < @ ) .


ICAM-@ expression was reduced in both CACs ( p < @ ) and late-outgrowth EPCs ( p < @ ) and VCAM-@ in late-outgrowth EPCs ( p < @ ) .


N-@ PUFA significantly decreased TNF - and MCP-@ expression in CACs and IL-@ , TNF - and MCP-@ in late-outgrowth EPCs ( p < @ ) .


Circulating EPC number significantly improved after @ weeks of a fish-enriched diet ( p < @ ) and returned to baseline levels after a @ week free-diet period ( p < @ ) .


Plasma EPA levels were independently and positively associated with EPC levels ( p < @ ) .


Our findings support the case of a beneficiary role played by n-@ PUFA in EPC function and bioavailability .


Although previous studies have illustrated improvements in surgical cohorts for patients with intervertebral disc herniation , there are limited data on predictors of long-term outcomes comparing surgical and nonsurgical outcomes .


We assessed outcomes of operative and nonoperative treatment for patients with intervertebral disc herniation and symptomatic radiculopathy at @years from the Spine Patient Outcomes Research Trial .


We specifically examined subgroups to determine whether certain populations had a better long-term outcome with surgery or nonoperative treatment .


Patients with symptomatic lumbar radiculopathy for at least @weeks associated with nerve root irritation or neurologic deficit on examination and a confirmed disc herniation on cross-sectional imaging were enrolled at @ different clinical sites .


Patients consenting to participate in the randomized cohort were assigned to surgical or nonoperative treatment using variable permuted block randomization stratified by site .


Those who declined randomization entered the observational cohort group based on treatment preference but were otherwise treated and followed identically to the randomized cohort .


Of those in the randomized cohort , @ of @ ( @ % ) provided @-year data and in the observational group @ of @ ( @ % ) .


Patients were treated with either surgical discectomy or usual nonoperative care .


By @years , only @ of @ ( @ % ) of those randomized to surgery had undergone surgery , whereas @ of @ ( @ % ) of those randomized to nonoperative treatment had undergone surgery .


The primary outcome measures were SF-@ bodily pain , SF-@ physical function , and Oswestry Disability Index collected at @weeks , @months , @months , @months , and then annually .


Further analysis studied the following factors to determine if any were predictive of long-term outcomes : sex , herniation location , depression , smoking , work status , other joint problems , herniation level , herniation type , and duration of symptoms .


The intent-to-treat analysis of the randomized cohort at @years showed no difference between surgical and nonoperative treatment for the primary outcome measures .


Secondary outcome measures of sciatica bothersomeness , leg pain , satisfaction with symptoms , and self-rated improvement showed greater improvement in the group randomized to surgery despite high levels of crossover .


The as-treated analysis of the combined randomized and observational cohorts , adjusted for potential confounders , showed advantages for surgery for all primary outcome measures ; however , this has the potential for confounding from other unrecognized variables .


Smokers and patients with depression or comorbid joint problems had worse functional outcomes overall ( with surgery and nonoperative care ) but similar surgical treatment effects .


Patients with sequestered fragments , symptom duration greater than @months , those with higher levels of low back pain , or who were neither working nor disabled at baseline showed greater surgical treatment effects .


The intent-to-treat analysis , which is complicated by high rates of crossover , showed no difference over @years for primary outcomes of overall pain , physical function , and back-related disability but did show small advantages for secondary outcomes of sciatica bothersomeness , satisfaction with symptoms , and self-rated improvement .


Subgroup analyses identified those groups with sequestered fragments on MRI , higher levels of baseline back pain accompanying radiculopathy , a longer duration of symptoms , and those who were neither working nor disabled at baseline with a greater relative advantage from surgery at @years .


Level II , therapeutic study .


See Instructions for Authors for a complete description of levels of evidence .


One of the major challenges in peptic ulcer bleeding ( PUB ) is rebleeding which is associated with up to a fivefold increase in mortality .


We examined if supplementary transcatheter arterial embolization ( STAE ) performed after achieved endoscopic hemostasis improves outcome in patients with high-risk ulcers .


The study was designed as a non-blinded , parallel group , randomized-controlled trial and performed in a university hospital setting .


Patients admitted with PUB from Forrest Ia - IIb ulcers controlled by endoscopic therapy were randomized ( @:@ ratio ) to STAE of the bleeding artery within @ h or continued standard treatment .


Randomization was stratified according to stigmata of hemorrhage .


Patients were followed for @ days .


Primary outcome was a composite endpoint where patients were classified into five groups based on transfusion requirement , development of rebleeding , need of hemostatic intervention and mortality .


Secondary outcomes were rebleeding , number of blood transfusions received , duration of admission and mortality .


Totally @ patients were included .


Of the @ patients allocated to STAE @ underwent successful STAE .


There was no difference in composite endpoint .


Two versus eight patients re-bled in the STAE and control group , respectively ( Intention-to-treat analysis ; p = @ ) .


After adjustment for possible imbalances a strong trend was noted between STAE and rate of rebleeding ( p = @ ) .


STAE is potentially useful for preventing rebleeding in high-risk PUB .


STAE can safely be performed in selected cases with high risk of rebleeding .


Further studies are needed in order to confirm these findings ; ClincialTrials.gov number , NCT@ .


Long-acting reversible contraceptive ( LARC ) methods , such as the intrauterine device and implant , are highly effective but used by less than @ % of US women .


The objective of our study was to improve LARC interest by enhancing clinic counseling .


A quality improvement methodology was used to evaluate intrauterine device service delivery in @ Chicago Title X clinics .


To address identified barriers , we developed a theory-based iOS application ( app ) for patients to use in the clinic waiting room using human-centered design .


The final prototype was tested in a randomized controlled trial in a Title X clinic with sexually active females ( @ % African American ) under age @ years .


Our sample of @ was chosen to detect an increase from @ % ( baseline ) to @ % ( app intervention ) in the proportion of patients expressing interest in discussing a LARC method during their clinic visit with @ % power and two-sided = @ .


After completing demographic and baseline knowledge questionnaires , participants were randomized @:@ to intervention ( app ) or standard care arms .


App users also completed a posttest .


Our primary outcome was expressed interest in discussing a LARC method during the clinic visit .


Secondary outcomes were contraceptive knowledge and LARC selection .


App testers ( n = @ ) preferred interactive , visually appealing design and video testimonials .


In the pilot randomized controlled trial ( n = @ ) , app users had a significantly higher knowledge of contraceptive effectiveness ( P = @ ) and increased interest in the implant ( @-@ @ % , P = @ ) after the intervention .


Users were highly satisfied with the app .


Staff reported no problems using the app in the clinic .


Use of a theory-based counseling app offers a novel method to optimize wait time while minimizing clinic flow disruption .


Preliminary data demonstrate that app use was associated with improvements in patients ' contraceptive knowledge and interest in the implant .


Aging is associated with a blunted anabolic response to dietary intake , possibly related to a decrease in systemically available amino acids ( AAs ) , which in turn may stem from increased splanchnic AA metabolism .


Splanchnic sequestration can be saturated by pulse feeding ( @ % of daily protein intake in a single meal ) , enabling increased protein synthesis .


The aim of this study was to explore whether protein pulse feeding increased postprandial AA concentrations , and if so whether this increase persisted after @ wk of dietary treatment .


This prospective randomized study enrolled @ elderly malnourished or at-risk patients in an inpatient rehabilitation unit .


All were given a controlled diet for @ wk .


In a spread diet ( SD ) group ( n = @ ) , dietary protein was spread over the four daily meals .


In a pulse diet ( PD ) group ( n = @ ) , @ % of dietary protein ( averaging @ g/kg body weight daily ) was consumed in one meal at noon .


The patients were evaluated on day @ and at @ wk for plasma postprandial ( five times from @ to +@ min ) AA concentrations ( expressed as area under the curve above baseline ) .


Protein pulse feeding was more efficient than protein spread feeding at increasing plasma postprandial AA concentrations , notably of essential AAs .


This increased postprandial AA bioavailability was maintained after @ wk .


This study demonstrates that increased postprandial AA bioavailability induced by protein pulse feeding persists after @ wk ( i.e. , that there is no metabolic adaptation blunting AA bioavailability ) .


Transcranial direct current stimulation ( tDCS ) is a non-invasive technique used for modulating cortical excitability in vivo in humans .


Here we evaluated the effect of tDCS on behavioral and electrophysiological aspects of physiological sucking and swallowing .


Twelve healthy subjects underwent three tDCS sessions ( anodal , cathodal and sham stimulation ) on separate days in a double-blind randomized order .


The active electrode was placed over the right swallowing motor cortex .


Repeated sucking and swallowing acts were performed at baseline and at @ and @ min after each tDCS session and the mean liquid bolus volume ingested at each time point was measured .