There were no significant differences in length of stay , complications , oral pain medication usage after discharge , or return to work .


After @ months , body image and cosmetic appearance were excellent for both groups and indistinguishable by most measures .


However , @-port patients reported better physical attractiveness ( @ @ vs @ @ ; p = @ ) and SILS patients reported better scars ( score @ @ vs @ @ ; p < @ ) .


Results are reported as mean SD .


Single-incision laparoscopic surgery appendectomy resulted in more pain and longer operative times without improving short-term recovery or complications .


Long-term body image and cosmetic appearance were excellent in both groups .


Primary hyperuricemia , an excess of uric acid in the blood , is a major public health problem .


In addition to the morbidity that is attributable to gout , hyperuricemia is also associated with metabolic syndrome , hypertension , and cardiovascular disease .


This study aims to assess the genetic associations between Apolipoprotein E ( APOE ) polymorphisms and hyperuricemia in a Chinese population .


A total of @ subjects ( @ hyperuricemic cases and @ normouricemic controls ) were recruited from the Ningxia Hui Autonomous Region , China .


A physical examination was performed and fasting blood was collected for biochemical tests , including determination of the levels of serum lipid , creatinine , and uric acid .


Multi-ARMS PCR was applied to determine the APOE genotypes , followed by an investigation of the distribution of APOE genotypes and alleles frequencies in the controls and cases .


The frequencies of the APOE-@ genotype ( @ % vs. @ % , P = @ ) and the APOE-@ allele ( @ % vs. @ % , P = @ ) were significantly higher in the hyperuricemic group than in the normouricemic group .


Furthermore , male cases were more likely to have the APOE-@ genotype and APOE-@ allele , compared with male controls .


In both Han and Hui subjects , cases were more likely to have the APOE-@ genotype and the APOE-@ allele compared with controls .


Furthermore , multivariate logistic regression showed that carriers of the APOE-@ genotype ( P = @ , OR = @ ) and the @ allele ( P = @ , OR = @ ) were significantly more likely to experience hyperuricemia than carriers of the @/@ genotype and the @ allele after adjustment for sex , body mass index ( BMI ) , diastolic blood pressure ( DBP ) , triglyceride ( TG ) , low density lipoprotein cholesterol ( LDL-C ) , creatinine ( Cr ) and fasting blood glucose ( FBG ) .


The APOE-@ genotype and the APOE-@ allele are associated with serum uric acid levels in Chinese subjects , indicating that individuals carrying the APOE-@ allele have a higher risk of hyperuricemia than non-carriers .


To investigate the clinical application of the fast track surgery ( FTS ) model based on preoperative nutritional risk screening ( NRS ) in patients with esophageal cancer .


@ patients with esophageal cancer who underwent surgery between January @ and April @ were randomly divided into study and control groups based on matched-pairs .


The study group underwent assessment using the NRS @ and received treatment before surgery and the control group was treated by the conventional method .


Postoperative indicators including time to first exsufflation , time to defecation , time to chest tube removal , hospitalization duration , and postoperative complications were examined after surgery .


Compared with the control group , the postoperative indicators including time to first exsufflation ( @ vs @ hours ) , time to first defecation ( @ vs @ days ) , time to chest tube removal ( @ vs @ days ) , postoperative hospitalization durations ( @ vs @ days ) , and total complication rate ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- ) were all significantly reduced in the study group ( p < @ ) .


The FTS model based on NRS can effectively promote postoperative rehabilitation of patients , reduce the incidence of postoperative complications , and shorten hospital stay .


A randomized , controlled clinical trial was conducted to compare the safety and whitening efficacy of high-adhesion tooth-whitening strips with a marketed in-office professional tooth-whitening system .


This open-label study was conducted in a private dental practice , and adult volunteers were assigned ( @:@ ) to either @ percent hydrogen-peroxide whitening strips ( Strip group ) or an in-office light plus @ percent hydrogen-peroxide whitening gel treatment ( In-office group ) .


The Strip group was instructed to treat the maxillary arch once daily for @ minutes over a @-day period , while the In-office group underwent professional application of light plus whitening gel in a single office visit .


Whitening response was measured as change in yellowness ( b * ) and lightness ( L * ) at Day @ using standardized digital images of the maxillary anterior teeth , while safety was assessed as tooth sensitivity and oral irritation occurrence .


A total of @ subjects enrolled , were randomized , and received treatment ; @ completed the study .


At Day @ , significant improvement in b * and L * was noted in both groups ( P@ @ ) .


The adjusted mean ( SE ) L * in the Strip group ( @ ( @ ) ) was significantly greater than that in the In-office group ( @ ( @ ) ) ( P = @ ) .


Both test products were well tolerated .


Overall , both the strip and in-office treatments resulted in significant tooth whitening .


To evaluate the High Five for Kids intervention effect on television within subgroups , examine participant characteristics associated with process measures and assess perceived helpfulness of television intervention components .


High Five ( randomized controlled trial of @ overweight/obese @-@ year-olds in Massachusetts -LSB- @-@ -RSB- ) reduced television by @ h/day .


@-year effects on television viewing , stratified by subgroup , were assessed using linear regression .


Among intervention participants ( n = @ ) , associations of intervention component helpfulness with television reduction were examined using linear regression and associations of participant characteristics with processes linked to television reduction ( choosing television and completing intervention visits ) were examined using logistic regression .


High Five reduced television across subgroups .


Parents of Latino ( versus white ) children had lower odds of completing @ study visits ( Odds Ratio : @ -LSB- @ % Confidence Interval : @ , @ -RSB- ) .


Parents of black ( versus white ) children had higher odds of choosing television ( Odds Ratio : @ -LSB- @ % Confidence Interval : @ , @ -RSB- ) , as did parents of obese ( versus overweight ) children and children watching @ h/day ( versus < @ ) at baseline .


Greater perceived helpfulness was associated with greater television reduction .


Clinic-based motivational interviewing reduces television viewing in children .


Low cost education approaches ( e.g. , printed materials ) may be well-received .


Parents of children at higher obesity risk could be more motivated to reduce television .


To evaluate efficacy and safety of intravitreal aflibercept ( IVT-AFL ) in Japanese patients with wet age-related macular degeneration ( wAMD ) from the VIEW @ trial .


In this double-masked study , patients were randomised to : @ mg IVT-AFL every @weeks ( @ q@ ) ; @mg IVT-AFL every @weeks ( @q@ ) ; @mg IVT-AFL every @weeks ( @q@ ) after @ monthly injections ; or @ mg ranibizumab every @weeks ( Rq@ ) .


Main efficacy outcomes included vision maintenance and best-corrected visual acuity ( BCVA ) at week @ .


At week @ , all Japanese patients in the IVT-AFL groups ( n = @ ) maintained vision , compared with @ % of Japanese patients ( n = @/@ ) treated with ranibizumab .


Japanese patients in all treatment groups showed improvement in BCVA after treatment .


The Rq@ , @q@ and @q@ groups experienced similar gains in BCVA from baseline .


The @ q@ group had higher gains due to an unexpected drop in BCVA between screening and baseline .


Central retinal thickness and mean area of choroidal neovascularisation decreased in all treatment groups with similar magnitude .


Ocular treatment-emergent adverse events were balanced across treatment groups .


IVT-AFL was effective and well tolerated in Japanese patients .


Outcomes in this population were consistent with those in the overall VIEW @ population .


Observational studies suggest a role for dietary nutrients such as vitamin E and selenium in cataract prevention .


However , the results of randomized clinical trials of vitamin E supplements and cataract have been disappointing and are not yet available for selenium .


To test whether long-term supplementation with selenium and vitamin E affects the incidence of cataract in a large cohort of men .


The Selenium and Vitamin E Cancer Prevention Trial ( SELECT ) Eye Endpoints Study was an ancillary study of the Southwest Oncology Group-coordinated SELECT , a randomized placebo-controlled @-arm trial of selenium and vitamin E conducted among @,@ men , @ years and older for African American participants and @ years and older for all other men , at @ participating sites in the United States , Canada , and Puerto Rico .


A total of @,@ SELECT participants from @ SELECT sites participated in the SELECT Eye Endpoints ancillary study .


Individual supplements of selenium ( @ g per day from L-selenomethionine ) and vitamin E ( @ IU per day of all rac -- tocopheryl acetate ) .


Incident cataract was defined as a lens opacity , age related in origin , and responsible for a reduction in best-corrected visual acuity to @/@ or worse based on self-reports confirmed by medical record review .


Cataract extraction was defined as the surgical removal of an incident cataract .


During a mean ( SD ) of @ ( @ ) years of treatment and follow-up , @ cases of cataract were documented .


There were @ cataracts in the selenium group and @ in the no selenium group ( hazard ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


For vitamin E , there were @ cases in the treated group and @ in the placebo group ( hazard ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


Similar results were observed for cataract extraction .


These data from a large cohort of apparently healthy men indicate that long-term daily supplementation with selenium and/or vitamin E is unlikely to have a large beneficial effect on age-related cataract .


The course of bipolar disorder progressively worsens in some patients .


Although responses to pharmacotherapy appear to diminish with greater chronicity , less is known about whether patients ' prior courses of illness are related to responses to psychotherapy .


Embedded in the Systematic Treatment Enhancement Program for Bipolar Disorder ( STEP-BD ) was a randomized controlled trial of psychotherapy for bipolar depression comparing the efficacy of intensive psychotherapy with collaborative care ( a three-session psycho-educational intervention ) .


We assessed whether the number of previous mood episodes , age of illness onset , and illness duration predicted or moderated the likelihood of recovery and time until recovery from a depressive episode in patients in the two treatments .


Independently of treatment condition , participants with one to nine prior depressive episodes were more likely to recover and had faster time to recovery than those with @ or more prior depressive episodes .


Participants with fewer than @ prior manic episodes had faster time to recovery than those with @ or more episodes .


Longer illness duration predicted a longer time to recovery .


Participants were more likely to recover in intensive psychotherapy than collaborative care if they had @-@ prior episodes of depression -LSB- number needed to treat ( NNT ) = @ -RSB- , but equally likely to respond to psychotherapy and collaborative care if they had one to nine ( NNT = @ ) or > @ ( NNT = @ ) depressive episodes .


Number of previous mood episodes and illness duration are associated with the likelihood and speed of recovery among bipolar patients receiving psychosocial treatments for depression .


This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer .


Patients in the COLOR II randomized trial , comparing laparoscopic and open surgery for rectal cancer , completed the European Organization for Research and Treatment of Cancer ( EORTC ) QLQ-CR@ questionnaire before surgery , and after @weeks , @ , @ and @months .


Adjusted mean differences on a @-point scale were calculated using changes from baseline value at the various time points in the domains of sexual functioning , sexual enjoyment , male and female sexual problems , and micturition symptoms .


Of @ randomized patients , @ completed this phase of the trial .


Their mean age was @years .


Surgery caused an anticipated reduction in genitourinary function after @weeks , with no significant differences between laparoscopic and open approaches .


An improvement in sexual dysfunction was seen in the first year , but some male sexual problems persisted .


Before operation @ per cent of men in the laparoscopic group and @ per cent in the open group reported some degree of erectile dysfunction .


This increased to @ and @ per cent respectively @weeks after surgery , and @ versus @ per cent at @months , with no significant differences between groups .


Micturition symptoms were less affected than sexual function and gradually improved to preoperative levels by @months .


Adjusting for confounders , including radiotherapy , did not change these results .


Sexual dysfunction is common in patients with rectal cancer , and treatment ( including surgery ) increases the proportion of patients affected .


A laparoscopic approach does not change this .


Rates of obesity are greatest in middle age .


Obesity is associated with altered activity of brain networks sensing food-related stimuli and internal signals of energy balance , which modulate eating behaviour .


The impact of healthy mid-life ageing on these processes has not been characterised .


We therefore aimed to investigate changes in brain responses to food cues , and the modulatory effect of meal ingestion on such evoked neural activity , from young adulthood to middle age .


Twenty-four healthy , right-handed subjects , aged @-@ @ years , were studied on separate days after an overnight fast , randomly receiving @ml water or @kcal mixed meal before functional brain magnetic resonance imaging while viewing visual food cues .


Across the group , meal ingestion reduced food cue-evoked activity of amygdala , putamen , insula and thalamus , and increased activity in precuneus and bilateral parietal cortex .


Corrected for body mass index , ageing was associated with decreasing food cue-evoked activation of right dorsolateral prefrontal cortex ( DLPFC ) and precuneus , and increasing activation of left ventrolateral prefrontal cortex ( VLPFC ) , bilateral temporal lobe and posterior cingulate in the fasted state .


Ageing was also positively associated with the difference in food cue-evoked activation between fed and fasted states in the right DLPFC , bilateral amygdala and striatum , and negatively associated with that of the left orbitofrontal cortex and VLPFC , superior frontal gyrus , left middle and temporal gyri , posterior cingulate and precuneus .


There was an overall tendency towards decreasing modulatory effects of prior meal ingestion on food cue-evoked regional brain activity with increasing age .


Healthy ageing to middle age is associated with diminishing sensitivity to meal ingestion of visual food cue-evoked activity in brain regions that represent the salience of food and direct food-associated behaviour .


Reduced satiety sensing may have a role in the greater risk of obesity in middle age .


To determine whether the addition of spa therapy to home exercises provides any benefit over exercises and the usual treatment alone in the management of generalised osteoarthritis associated with knee osteoarthritis .


This study was a post-hoc subgroup analysis of our randomised multicentre trial ( www.clinicaltrial.gov : NCT@ ) .


Participants who met the inclusion criteria of generalized osteoarthritis ( Kellgren , American College of Rheumatology , or Dougados criteria ) were extracted from the original randomised controlled trial .


They had been randomised using Zelen randomisation .


The treatment group received @days of spa treatment in addition to a home exercise programme .


Main outcome was number of patients achieving minimal clinically important improvement at six months ( MCII ) ( -@ mm on the VAS pain scale and/or -@ points in a WOMAC function subscale ) , and no knee surgery .


Secondary outcomes included the `` patient acceptable symptom state '' ( PASS ) defined as VAS pain @ mm and/or WOMAC function subscale @ points .


From the original @ participants , @ patients could be categorized as having generalised osteoarthritis .


At sixth month , @ ( @ in control and @ in SA group ) patients , were analysed for the main criteria .


MCII was observed more often in the spa group ( n = @/@ vs. @/@ , P = @ ) .


There was no difference for the PASS ( n = @/@ vs. @/@ , P = @ ) .


This study indicates that spa therapy with home exercises may be superior to home exercise alone in the management of patients with GOA associated with knee OA .


This study compared the efficacy of intravenous magnesium sulphate , terbutaline and aminophylline for children with acute , severe asthma poorly responsive to standard initial treatment .


We enrolled @ children , aged one to @ years , who had failed to respond to initial standard treatment for acute , severe asthma , in this randomised controlled trial .


They received either intravenous magnesium sulphate , terbutaline or aminophylline .


Responses were monitored using a modified Clinical Asthma Severity ( CAS ) score .


The primary outcome was treatment success , defined as a reduction in the CAS of four points or more @ h after starting the intervention .


The magnesium sulphate group had higher treatment success ( @/@ , @ % ) than the terbutaline and aminophylline groups ( both @/@ , @ % ) ( p = @ ) and faster resolution of retractions , wheeze and dyspnoea ( p < @ ) .


No adverse events occurred among patients receiving magnesium sulphate , but two patients receiving terbutaline had hypokalemia and nine patients receiving aminophylline had nausea and , or , vomiting .


Adding a single dose of Intravenous magnesium sulphate to inhaled beta@-agonists and corticosteroids was more effective , and safer , than using terbutaline or aminophylline when treating a child with acute severe asthma poorly responsive to initial treatment .


To evaluate the efficacy and adverse effects of an i.v. infusion of paracetamol during the active phase of labor as compared with sterile water ( placebo ) as a method for intrapartum analgesia .


In a triple-blind , randomized , placebo-controlled trial , @ low-risk primiparous women presenting in active labor at Ain Shams University Maternity Hospital , Cairo , Egypt , between August @ and October @ , were allocated to receive either @ mg i.v. of paracetamol ( n = @ ) or sterile water ( n = @ ) .


The primary outcomes were the efficacy of the drug to supply adequate analgesia as measured by a change in the visual analog scale ( VAS ) pain intensity score at various time points after drug administration and the need for additional rescue analgesia .


The secondary outcomes included the presence of adverse maternal or fetal events .


Compared to controls , i.v. infusion of paracetamol was associated with significantly lower VAS score @ and @ min after the start of medication ; also , there was a significantly lower incidence of need for rescue medication ( @/@ -LSB- @ % -RSB- vs @/@ -LSB- @ % -RSB- , P < @ ) at @ min after the start of medication .


There were no recorded maternal adverse effects in either group .


There were no differences in occurrence of intrapartum fetal distress or neonatal Apgar scores between both groups .


Paracetamol appears to be a safe and effective medicine that can be used during the intrapartum period .


Alternate day fasting ( ADF ; @-h feeding/@-h @ % energy intake at lunchtime ) , is effective for weight loss , but diet tolerability is questionable .


Moving the fast day meal to dinnertime , or dividing it into smaller meals , may improve tolerability .


Accordingly , this study compared the effects of ADF with three meal times on body weight and heart disease risk .


Obese subjects ( n = @ ) were randomized to @ of @ groups for @ weeks : @ ) ADF-L : lunch , @ ) ADF-D : dinner , or @ ) ADF-SM : small meals .


Body weight decreased similarly ( P < @ ) in all groups ( ADF-L : @ kg , ADF-D @ kg , ADF-SM @ kg ) .


Reductions ( P < @ ) in fat mass and visceral fat were also comparable .


Plasma lipids remained unchanged , and low density lipoprotein ( LDL ) particle size increased ( P < @ ) in all groups ( @ ) .


Systolic blood pressure decreased ( P < @ ) by ADF-SM only .


Fasting glucose , insulin , and HOMA-IR remained unchanged .


Thus , allowing individuals to consume the fast day meal at dinner or small meals produces similar weight loss and cardio-protection as consuming the meal at lunch .


This flexibility in meal timing may increase tolerability and long-term adherence to ADF protocols .


To determine whether aminophylline reduced the duration of respiratory support in children admitted to intensive care with bronchiolitis .


A multicentre , randomised , double-blind , placebo controlled trial .


Paediatric intensive care units in teaching hospitals .


Forty-five children with severe bronchiolitis .


Patients were randomly assigned to receive an infusion of aminophylline ( @ ) or placebo ( @ ) .


The primary outcome measure was the number of hours of respiratory support required in the @ hours after randomisation ; respiratory support was defined as either nasal continuous positive airways pressure or mechanical ventilation .


The trial was stopped early due to poor recruitment .


Respiratory support was required for a median of only @ days ( interquartile range -LSB- IQR -RSB- , @-@ @ days ) in the aminophylline group compared with @ days ( IQR , @-@ @ ) days in the placebo group .


However , more patients in the placebo group were receiving respiratory support at the time of randomisation and , after adjustment for this , there was no suggestion of a beneficial effect of aminophylline among the small number of patients studied ( P = @ , exact log-rank test stratified by respiratory support at the time of randomisation and censored at the time of death in one child in the aminophylline group ) .


Not enough children were recruited for the study to test the hypothesis that aminophylline reduces the need for respiratory support in severe bronchiolitis .


Consequently , the role of aminophylline in the management of severe bronchiolitis remains unknown .


We aimed to compare the effectiveness of immobilization in abduction and external rotation vs immobilization in adduction and internal rotation after primary anterior dislocation of the shoulder .


The study randomized @ patients ( age range , @-@ years ) with the diagnosis of primary anterior dislocation of the shoulder to receive immobilization in adduction and internal rotation ( AdIR , n = @ ) using sling and swathe bandage or immobilization in abduction and external rotation ( AbER , n = @ ) with a stabilizer brace .


Patients received a rehabilitation program @ weeks after the intervention .


After a @-month follow-up , @ % in the AdIR group and @ % in the AbER group had recurrence ( P < @ ) .


The difference in the recurrence rate was greater in the subgroup aged between @ and @ years ( @ % in the AdIR group and @ % in the AbER group , P < @ ) .


Ten patients in the AbER group ( @ % ) and @ in the AdIR group ( @ % ) discontinued shoulder immobilization before @ weeks ( P = @ ) .


In patients without recurrence , the anterior apprehension test was positive in @ of @ in the AdIR group ( @ % ) and in @ of @ in the AbER group ( @ % , P = @ ) .


Immobilization with the shoulder joint in abduction and external rotation is an effective method to reduce the risk of recurrence after primary anterior shoulder dislocations and should be preferred to the traditional method of immobilization in adduction and internal rotation in clinical practice .


Deep brain stimulation ( DBS ) has been proposed as a treatment option for severe Tourette 's syndrome on the basis of findings from open-label series and small double-blind trials .


We aimed to further assess the safety and efficacy of bilateral globus pallidus internus ( GPi ) DBS in patient 's with severe Tourette 's syndrome .


In a randomised , double-blind , crossover trial , we recruited eligible patients ( severe medically refractory Tourette 's syndrome , age @ years ) from two clinics for tertiary movement disorders in the UK .


Enrolled patients received surgery for GPi DBS and then were randomly assigned in a @:@ ratio ( computer-generated pairwise randomisation according to order of enrolment ) to receive either stimulation on-first or stimulation off-first for @ months , followed by a switch to the opposite condition for a further @ month period .


Patients and rating clinicians were masked to treatment allocation ; an unmasked clinician was responsible for programming the stimulation .


The primary endpoint was difference in Yale Global Tic Severity Scale ( YGTSS ) total score between the two blinded conditions , assessed with repeated measures ANOVA , in all patients who completed assessments during both blinded periods .


After the end of the blinded crossover phase , all patients were offered continued DBS and continued to have open-label stimulation adjustments and objective assessments of tic severity until database lock @ month after the final patient 's final trial-related visit .


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


Between Nov @ , @ , and Oct @ , @ , we enrolled @ patients ( @ men , four women ; mean age @ years -LSB- SD @ -RSB- ) .


@ patients were randomly assigned and @ completed assessments in both blinded periods ( seven in the on-first group , six in the off-first group ) .


Mean YGTSS total score in these @ patients was @ ( SD @ ) at baseline , @ ( SD @ ) for the off-stimulation period , and @ ( SD @ ) for the on-stimulation period .


Pairwise comparisons in YGTSS total scores after Bonferroni correction were significantly lower at the end of the on-stimulation period compared with the off-stimulation period , with a mean improvement of @ points ( @ % CI @-@ , p = @ ) , equivalent to a difference of @ % ( @ % CI @-@ ) .


All @ patients received stimulation in the open-label phase .


Overall , three serious adverse events occurred ( two infections in DBS hardware at @ and @ weeks postoperatively , and one episode of deep-brain-stimulation-induced hypomania during the blinded on-stimulation period ) ; all three resolved with treatment .


GPi stimulation led to a significant improvement in tic severity , with an overall acceptable safety profile .


Future research should concentrate on identifying the most effective target for DBS to control both tics and associated comorbidities , and further clarify factors that predict individual patient response .


The Sodium Lowering in Dialysate ( SoLID ) trial is an ongoing a multi-center , prospective , randomised , single-blind ( assessor ) , controlled , parallel assignment clinical trial , enrolling @ home and self-care hemodialysis ( HD ) patients from @ centers in New Zealand .


The trial will evaluate the hypothesis that lower dialysate -LSB- Na + -RSB- during HD results in lower left ventricular ( LV ) mass .


Since it 's inception , observational evidence has suggested increased mortality risk with lower dialysate -LSB- Na + -RSB- , possibly due to exacerbation of intra-dialytic hypotension and subsequent myocardial micro-injury .


The Myocardial Micro-injury and Cardiac Remodeling Extension Study in the Sodium Lowering In Dialysate Trial ( Mac-SoLID study ) aims to determine whether lower dialysate -LSB- Na + -RSB- results in ( i ) increased levels of high-sensitivity Troponin T ( hsTnT ) , a well-established marker of intra-dialytic myocardial micro-injury in HD populations , and ( ii ) increased fixed LV segmental wall motion abnormalities , a marker of recurrent myocardial stunning and micro-injury , and ( iii ) detrimental changes in LV geometry due to maladaptive homeostatic mechanisms .


The SoLID trial and the Mac-SoLID study are funded by the Health Research Council of New Zealand .


Key exclusion criteria : patients who dialyse > @ times per week , pre-dialysis serum sodium < @ mM , and maintenance haemodiafiltration .


In addition , some medical conditions , treatments or participation in other dialysis trials that contraindicate the study intervention or confound its effects , will be exclusion criteria .


The intervention and control groups will receive dialysate sodium @ mM and @ mM respectively , for @ months .


The primary outcome measure for the Mac-SOLID study is repeated measures of -LSB- hsTnT -RSB- at @ , @ , @ , @ , and @ months .


The secondary outcomes will be assessed using cardiac magnetic resonance imaging ( MRI ) , and comprise LV segmental wall motion abnormality scores , LV mass to volume ratio and patterns of LV remodeling at @ and @ months .


The Mac-SoLID study enhances and complements the SoLID trial .


It tests whether potential gains in cardiovascular health ( reduced LV mass ) which low dialysate -LSB- Na + -RSB- is expected to deliver , are counteracted by deterioration in cardiovascular health through alternative mechanisms , namely repeated LV stunning and micro-injury .


The role of saturated fatty acids ( SFAs ) in chronic disease remains controversial ; inflammation is one pathway by which SFAs influence the risk for chronic disease .


The aim of this study was to investigate the associations between red blood cell ( RBC ) phospholipid SFAs and systemic inflammation .


As part of a randomized controlled trial , we measured RBC phospholipid FA composition in @ generally healthy adults twice at @-mo intervals .


We estimated associations of RBC total SFAs and two major SFA subtypes , palmitic and stearic acids , with C-reactive protein ( CRP ) , interleukin ( IL ) -@ , white blood count ( WBC ) , and a composite inflammation measure using generalized estimating equations in multivariable FA substitution models .


Mean ( SD ) SFA level across both visits was @ % @ % of the total RBC FAs , mainly palmitic ( @ % @ % ) and stearic ( @ % @ % ) acids .


In models adjusted for age , sex , race , smoking , body mass index , statin use , aspirin use , transunsaturated FAs , and -@ FAs , SFAs were significantly associated with IL-@ ( @ % increase per @ SD increment ; @ % confidence interval -LSB- CI -RSB- , @ % -@ % ; P = @ ) and the composite inflammation measure ( P = @ ) and marginally associated with CRP ( @ % increase ; @ % CI , -@ % to @ % ; P = @ ) , but not associated with WBC .


Stearic acid was positively associated with CRP ( @ % increase ; @ % CI , @ % -@ % ; P = @ ) .


Palmitic acid was marginally associated with the composite inflammation measure ( P = @ ) and , upon additional -@ FA adjustment , significantly associated with IL-@ ( @ % increase ; @ % CI , @ % -@ % ; P = @ ) .


RBC SFAs , which represent longer-term dietary intake , are positively associated with inflammation .


In particular , palmitic acid was associated with IL-@ , and stearic acid was associated with CRP after multivariable adjustment .


To compare the efficacy and safety of two insulin intensification strategies in patients with type @ diabetes inadequately controlled on basal insulin glargine with metformin and/or pioglitazone .


A multinational , randomized , open-label trial that compared insulin lispro low mixture ( LM@ ; n = @ ) twice daily with a basal-prandial regimen of insulin glargine once daily and insulin lispro once daily ( IGL ; n = @ ) over @ weeks in patients with HbA@c @-@ @ % and fasting plasma glucose @ mmol/l .


The primary objective was to assess non-inferiority -LSB- per-protocol ( PP ) population -RSB- , and then superiority -LSB- intention-to-treat ( ITT ) population -RSB- , of LM@ versus IGL according to change in HbA@c after @ weeks ( non-inferiority margin @ % , two-sided significance level @ ) .


Estimated change -LSB- least squares ( LS ) mean ( @ % CI ) -RSB- in HbA@c after @ weeks : -@ ( -@ , -@ ) % with LM@ and -@ ( -@ , -@ ) % with IGL .


Non-inferiority was shown -LSB- LS mean ( @ % CI ) HbA@c treatment difference -@ ( -@ , -@ ) ( PP population ) -RSB- ; gated superiority assessment showed a statistically significant advantage for LM@ ( p = @ ; ITT population ) .


Mean blood glucose , glycaemic variability , overall tolerability and hypoglycaemic episodes per patient-year did not show significant differences between treatments during the study .


In patients with type @ diabetes inadequately controlled on once-daily basal insulin glargine and metformin and/or pioglitazone , intensification with LM@ was superior to a basal-prandial approach in terms of reduction in HbA@c after @ weeks and did not increase hypoglycaemia episodes .


Prototyping technologies for reconstructions consist of obtaining a @-dimensional model of the object of interest .


Solid models are constructed by the deposition of materials in successive layers .


The purpose of this study was to perform a double-blind , randomized , prospective study to evaluate the efficacy of prototype use in head and neck surgeries .


Thirty-seven cases were randomized into prototype and nonprototype groups .


The following factors were recorded : the time of plate and locking screw apposition , flap size , time for reconstruction , and an aesthetic evaluation .


The prototype group exhibited a reduced surgical time ( @ minutes vs @ minutes , respectively ; p = @ ) , a tendency to reduce the size of the bone flap taken for reconstruction , and better aesthetic results than the group that was not prototyped .


The use of prototyping demonstrated a trend toward a reduced surgical time , smaller bone flaps , and better aesthetic results .


This study 's objective was to determine the efficacy of benefits counseling in a clinical trial .


There has been concern that disability payments for psychiatric disorders reduce incentives for employment and rehabilitation .


Benefits counseling , with education about opportunities to work and the financial implications of work on receipt of disability benefits , may counter these disincentives .


This single-blind , six-month randomized clinical trial enrolled @ veterans who had applied for service-connected compensation for a psychiatric condition .


Veterans were randomly assigned to either four sessions of benefits counseling or of a control condition involving orientation to the U.S Department of Veterans Affairs health care system and services .


Days of paid work and work-related activities were assessed at follow-up visits by using a timeline follow-back calendar .


Veterans assigned to benefits counseling worked for pay for significantly more days than did veterans in the control group ( effect size = @ , p < @ ) , reflecting an average of three more days of paid employment during the @ days preceding the six-month follow-up .


Benefits counseling was associated with increased use of mental health services , but this correlation did not mediate the effect of benefits counseling on working .


Barriers to employment associated with disability payments are remediable with basic counseling .


More research is needed to understand the active ingredient of this counseling and to strengthen the intervention .


Many believe that the regular treatment for multibacillary ( MB ) leprosy cases could be shortened .


A shorter treatment allowing uniformity in treatment for all cases renders case classification superfluous and therefore simplifies leprosy control .


To evaluate the association between treatment duration and the trend in bacteriological index ( BI ) decrease over time among patients given Uniform MDT ( UMDT ) compared to those given regular MDT ( RMDT ) .


An open-label randomised clinical trial to compare the present routine treatment with one lasting six month .


Patient intake was from March @ to February @ .


To evaluate the trend of BI as a function of time , a multilevel linear with mixed effects model was fixed to the two study groups and also four groups after stratification by BI , less than @ and @ or more .


The BI fall was higher among those taking RMDT , this difference however was not statistically significant .


The results presented here support the possibility of use of UMDT in the field , but further follow up is still needed for a final conclusion .


To assess whether the Multidisciplinary Risk Assessment and Management Program for Patients with Diabetes Mellitus ( RAMP-DM ) led to improvements in biomedical outcomes , observed cardiovascular events and predicted cardiovascular risks after @-month intervention in the primary care setting .


A random sample of @,@ people with diabetes enrolled to RAMP-DM for at least @months was selected and @,@ people with diabetes under the usual primary care were matched by age , sex , and HbA@c level at baseline as the usual care group .


Biomedical and cardiovascular outcomes were measured at baseline and at @-month after the enrollment .


Difference-in-differences approach was employed to measure the effect of RAMP-DM on the changes in biomedical outcomes , proportion of subjects reaching treatment targets , observed and predicted cardiovascular risks .


Compared to the usual care group , RAMP-DM group had lower cardiovascular events incidence ( @ % vs @ % , P = @ ) , and net decrease in HbA@c ( -@ % , P < @ ) , SBP ( -@ mmHg , P < @ ) and @-year cardiovascular disease ( CVD ) risks ( total CVD risk , -@ % , P < @ ; coronary heart disease ( CHD ) risk , -@ % , P < @ ; stroke risk , -@ % , P < @ ) .


The RAMP-DM subjects witnessed significant rises in the proportion of reaching treatment targets of HbA@c , and SBP/DBP .


After adjusting for confounding variables , the significance remained for HbA@c , predicted CHD and stroke risks .


The RAMP-DM resulted in greater improvements in HbA@c and reduction in observed and predicted cardiovascular risks at @months follow-up , which indicated a risk-stratification multidisciplinary intervention was an effective strategy for managing Chinese people with diabetes in the primary care setting .


The incidence of sick sinus syndrome will increase due to population ageing .


Consequently , this will result in an increase in the number of pacemaker implantations .


The atrial lead is usually implanted in the right atrial appendage , but this position may be ineffective for prevention of atrial fibrillation .


It has been suggested that pacing distally in the coronary sinus might be more successful in preventing atrial fibrillation episodes .


The aim of this trial is to study the efficacy of distal coronary sinus versus right atrial appendage pacing in preventing atrial fibrillation episodes in patients with sick sinus syndrome .


This study is designed as a multicenter , randomized controlled trial .


Patients with sick sinus syndrome and at least one atrial fibrillation episode of @ seconds or more in the six months before recruitment will be eligible for participation in this study.All participants will be randomized between pacing distally in the coronary sinus and right atrial appendage .


Randomization is stratified for all participating centers .


Conventional dual-chamber pacemakers with advanced home monitoring functionality will be implanted .


The ventricular lead will be implanted in the right ventricular apex .


The first three months of the @-month follow-up period are considered as run-in time .


During the pre-randomization visit and follow-up , an interview , electrocardiogram and pacemaker assessment will be performed , prescribed antiarrhythmic medication will be reviewed and patients will be asked to complete an SF-@ questionnaire .


An echocardiographic examination will be conducted in the pre-randomization phase and at the end of each follow-up year .


Home monitoring will be used to send daily reports in case of atrial fibrillation episodes .


This randomized controlled trial is the first in which home monitoring will be used to compare atrial fibrillation recurrences between pacing in the distal coronary sinus or right atrial appendage .


Home monitoring gives the opportunity to accurately detect atrial fibrillation episodes and to study characteristics of atrial fibrillation episodes .


Should distal coronary sinus pacing significantly diminish atrial fibrillation recurrences , this study will redefine the preferential location of an atrial lead for preventive pacing .


Negative lifestyle factors are known to be associated with increased cardiovascular risk ( CVR ) in children , but research on their combined impact on a general population of children is sparse .


Therefore , we aimed to quantify the combined impact of easily assessable negative lifestyle factors on the CVR scores of randomly selected children after @ years .


Of the @ randomly selected @ - to @-year-old children , @ children participated in a baseline health assessment , and @ % were assessed again after @ years .


Measures included anthropometry , fasting blood samples , and a health assessment questionnaire .


Participants scored one point for each negative lifestyle factor at baseline : overweight ; physical inactivity ; high media consumption ; little outdoor time ; skipping breakfast ; and having a parent who has ever smoked , is inactive , or overweight .


A CVR score at follow-up was constructed by averaging sex - and age-related z-scores of waist circumference , blood pressure , glucose , inverted high-density lipoprotein , and triglycerides .


The age - , sex - , pubertal stage - , and social class-adjusted probabilities ( @ % confidence interval ) for being in the highest CVR score tertile at follow-up for children who had at most one ( n = @ ) , two ( n = @ ) , three ( n = @ ) , four ( n = @ ) , or five or more ( n = @ ) risky lifestyle factors were @ % ( @-@ @ ) , @ % ( @-@ @ ) , @ % ( @-@ @ ) , @ % ( @-@ @ ) , and @ % ( @-@ @ ) , respectively .


Even in childhood , an accumulation of negative lifestyle factors is associated with higher CVR scores after @ years .


These negative lifestyle factors are easy to assess in clinical practice and allow early detection and prevention of CVR in childhood .


Transcranial direct current stimulation ( tDCS ) and auditory residual inhibition ( RI ) are short lasting non-invasive techniques that can suppress tinnitus in some people .


A pilot study was undertaken to evaluate methods to measure a potential additive effect of these treatments .


Ten participants ( mean age @ years ) with chronic tinnitus underwent four sessions of anodal tDCS of the left temporoparietal area ( LTA ) combined with @min of auditory stimulation ( broadband noise presented at tinnitus minimum masking level -LSB- MML -RSB- +@ dB ) , either before , during or immediately after tDCS and in a sham controlled session .


Participants continuously monitored and recorded their MML on custom software prior to stimulation , during @ min of tDCS , and @ min following tDCS .


A tinnitus loudness rating was undertaken before and after completion of testing .


Nine out of ten participants completed the study , one participant dropped out after two sessions due to self-reported worsening in tinnitus symptoms .


Seven out of nine participants reported transient tinnitus suppression when sound stimulation was presented along with tDCS .


No reliable change in MML was observed .


This is the first study to examine the feasibility of continuously measuring MML while providing a combination of auditory and noninvasive brain stimulation simultaneously .


We propose modifications in the protocol used , to find ways to increase the duration of auditory RI and investigate its underlying mechanisms .


Recommendations for further research are discussed .


Apathy in the context of treated major depressive disorder ( MDD ) is a frequently observed phenomenon in clinical practice .


This study aimed to assess the validity of the Rothschild Scale for Antidepressant Tachyphylaxis ( RSAT ) and the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire ( CPFQ ) for measuring apathy , and to assess the relationship between apathy and possible contributing factors , in patients with MDD and residual apathy in the absence of depressed mood .


The underlying structure and validity of the RSAT and CPFQ were assessed via factor analysis and correlation with the Apathy Evaluation Scale-Clinician rated version ( AES-C ) in @ patients who had previously responded to treatment with a selective serotonin reuptake inhibitor .


The relationship between apathy and contributing variables was investigated via structural equation modeling .


Correlation and regression analyses were conducted to examine the relationship between the Sheehan Disability Scale ( SDS ) and the RSAT , CPFQ , and AES-C .


The RSAT and CPFQ were validated with the AES-C with respect to energy and motivation .


The latent variable `` Energy and Interest '' , based on the energy , motivation , and interest items ( RSAT and CPFQ ) , was a major contributing factor to apathy .


Improvements in function ( SDS ) were significantly correlated with , and predicted by , improvements in apathy and cognitive and physical functioning ( assessed by the RSAT , CPFQ , and AES-C ) .


These analyses provide further information on apathy and its assessment in the context of treated MDD .


A better understanding of apathy will aid further investigation of this phenomenon and , ultimately , determination of the most appropriate approach for its clinical management .


Caring for people with dementia in dementia special care units is a demanding job .


Challenging behaviour is one of the factors influencing the job satisfaction and burnout of care staff .


A care programme for the challenging behaviour of nursing home residents with dementia might , next to diminishing the challenging behaviour of residents , improve job satisfaction and reduce the care staff 's feelings of burnout .


To determine the effects of a care programme for the challenging behaviour of nursing home residents with dementia on the burnout , job satisfaction and job demands of care staff .


The care programme was implemented according to a stepped wedge design in which care units were randomly divided over five groups with different time points of starting with implementation .


@ Dutch dementia special care units .


Care staff members of the @ units .


The care programme consists of an education package and of various structured assessment tools that guide professionals through the multidisciplinary detection , analysis , treatment and evaluation of treatment of challenging behaviour .


Burnout , job satisfaction and job demands were measured before implementation , halfway through the implementation process and after all the care units had implemented the care programme .


Burnout was measured with the Dutch version of the Maslach burnout inventory ( UBOS-C , three subscales ) ; job satisfaction and job demands were measured with subscales of the Leiden Quality of Work Questionnaire .


Mixed model analyses were used to determine effects .


Care staff could not be blinded for the intervention .


Of the @ questionnaires , @ were returned ( response @ % , @ control measurements , @ intervention measurements ) by @ unique care staff members .


Significant effects were found on job satisfaction ( @ , @ % CI @-@ @ ) .


On the other outcomes , no significant changes in the scores were found .


Positive effects of using the Grip on Challenging behaviour care programme were found on job satisfaction , without an increase in job demands .


Novel strategies are required to increase school-based physical activity levels of children .


Integrating physical activity in mathematics lessons may lead to improvements in students ' physical activity levels as well as enjoyment , engagement and learning .


The primary aim of this study is to evaluate the impact of a curriculum-based physical activity integration program known as EASY Minds ( Encouraging Activity to Stimulate Young Minds ) on children 's daily school time physical activity levels .


Secondary aims include exploring the impact of EASY Minds on their engagement and ` on task ' behaviour in mathematics .


Grade @/@ classes from eight public schools in New South Wales , Australia will be randomly allocated to intervention ( n = @ ) or control ( n = @ ) groups .


Teachers from the intervention group will receive one day of professional development , a resource pack and asked to adapt their lessons to embed movement-based learning in their daily mathematics program in at least three lessons per week over a six week period .


Intervention support will be provided via a weekly email and three lesson observations .


The primary outcomes will be children 's physical activity levels ( accelerometry ) across both the school day and during mathematics lessons ( moderate-to-vigorous physical activity and sedentary time ) .


Children 's ` on-task ' behaviour , enjoyment of mathematics and mathematics attainment will be assessed as secondary outcomes .


A detailed process evaluation will be undertaken .


EASY Minds is an innovative intervention that has the potential to improve key physical and academic outcomes for primary school aged children and help guide policy and practice regarding the teaching of mathematics .


Daily diaries are a useful way of measuring fluctuations in pain-related symptoms .


However , traditional diaries do not assure the gathering of data in real time , not solving the problem of retrospective assessment .


Ecological momentary assessment ( EMA ) by means of electronic diaries helps to improve repeated assessment .


However , it is important to test its feasibility in specific populations in order to reach a wider number of people who could benefit from these procedures .


The present study compares the compliance and acceptability of an electronic diary running on a smartphone using a crossover design for a sample with a specific pain condition , fibromyalgia and low familiarity with technology .


Forty-seven participants were randomly assigned to one of two conditions : ( @ ) paper diary - smartphone diary and ( @ ) smartphone diary - paper diary , using each assessment method for @ week .


The findings of this study showed that the smartphone diary made it possible to gather more accurate and complete ratings .


Besides , this method was well accepted by a sample of patients with fibromyalgia referred by a public hospital , with an important proportion of participants with low level of education and low familiarity with technology .


The findings of this study support the use of smartphones for EMA even in specific populations with a specific pain condition , fibromyalgia and with low familiarity with technology .


These methods could help clinicians and researchers to gather more accurate ratings of relevant pain-related variables even in populations with low familiarity with technology .


To compare the difference in the efficacy on post-stroke constipation between acupuncture therapy of regulating qi circulation of fe-organ and Shengxue Tongbian Capsules .


Seventy-five patients of post-stroke constipation were randomized into an acupuncture group ( @ cases ) and a Chinese medicine group ( @ cases ) .


The unit mode comprehensive therapy of stroke was adopted as basic treatment in the two groups .


In the acupuncture group , acupuncture therapy of regulating qi circulation of fu-organ was added at Tianshu ( ST @ ) , Zhigou ( TE @ ) , Qihai ( CV @ ) and Zusanli ( ST @ ) , once every day .


In the Chinese medicine group , Shengrue Tongbian Capsules were supplemented for oral administration , once every day , @ g each time .


The clinical symptom score of constipation was observed before treatment , after @ and @ weeks treatment in the two groups , respectively .


The efficacy in @ week and @ weeks of treatment and the adverse reaction were observed .


In @ and @ weeks of treatment , the clinical symptom score of constipation was reduced significantly as compared with that before treatment in the two groups ( all P < @ ) .


The improvements in the acupuncture group were significant than those in the Chinese medicine group in @ weeks of treatment ( @ + / - @ vs @ + / - @ , P < @ ) .


Concerning to the occurrence of adverse reaction , there was @ case of local bruises in needling local site in the acupuncture group ; and there were @ case of abdominal pain , @ cases of diarrhea and @ cases of nausea and vomiting in the Chinese medicine group .


Both the acupuncture therapy of regulating qi circulation of fu-organ and Shengxue Tongbian Capsules achieve the significant efficacy on post-stroke constipation .


The efficacy of the acupuncture therapy of regulating qi circulation of fe-organ is better and the adverse reaction is less after long-term persistent treatment .


Diabetes-associated autoantibodies can be detected in adult-onset diabetes , even when initially non-insulin requiring , i.e. , with latent autoimmune diabetes .


We aimed to identify adult-onset autoimmune diabetes in patients with established `` type @ diabetes '' participating in the Collaborative Atorvastatin Diabetes Study ( CARDS ) to characterize their phenotype and clinical outcome .


We prospectively studied @,@ European patients with presumed type @ diabetes ( mean age @ years , diabetes duration @ years ) for outcomes at @ years after randomization to either atorvastatin or placebo .


Subjects were screened for autoantibodies to GAD ( GADA ) , insulinoma-associated antigen-@ ( IA-@A ) , and zinc-transporter @ ( ZnT@A ) .


A total of @ patients ( @ % ) had GADA , of whom @ ( @ % ) and @ ( @ % ) were also positive for IA-@A and ZnT@A , respectively .


At baseline , @ % of GADA-positive patients were not on insulin .


Fewer autoantibody-positive than autoantibody-negative patients had metabolic syndrome ( @ vs. @ % ) , and more were on insulin ( @ vs. @ % ) ( P < @ for each ) without lower HbA@c ( @ mmol/mol -LSB- @ % -RSB- vs. @ mmol/mol -LSB- @ % -RSB- ) .


The frequency of microvascular and macrovascular events was similar in both cohorts , independent of atorvastatin .


Adult-onset autoimmune diabetes was prevalent , even in patients with established diabetes presumed to have type @ diabetes .


After @ years ' diabetes duration , nearly half the patients with autoimmune diabetes were not on insulin treatment and almost two-thirds had metabolic syndrome .


The type of diabetes , whether autoimmune diabetes or type @ diabetes , did not impact the risk of microvascular disease .


To compare the intraocular pressure ( IOP ) - lowering efficacy and safety of brinzolamide @ % and brimonidine @ % fixed combination ( BBFC ) with that of brinzolamide @ % or brimonidine @ % monotherapy , all dosed @ times per day ( BID ) .


Six-month , phase @ , randomized , multicenter , double-masked clinical trial .


A total of @ patients with primary open-angle glaucoma or ocular hypertension who had insufficient IOP reduction with their current therapeutic regimen or who were receiving @ IOP-lowering medications .


Patients received BBFC ( n = @ ) , brinzolamide @ % ( n = @ ) , or brimonidine @ % ( n = @ ) BID .


The primary end point was mean change in diurnal IOP from baseline to month @ .


Supportive end points included mean diurnal IOP change from baseline at week @ , week @ , and month @ ; and mean IOP , mean IOP change from baseline , mean percentage IOP change from baseline , and percentage of patients with IOP < @ mmHg at week @ , week @ , month @ , and month @ at each assessment time point ( i.e. , @ am , @ am , and @ pm ) .


Adverse events were recorded throughout the study .


Baseline diurnal IOP was similar among groups ( mean standard deviation : BBFC , @ @ mmHg ; brinzolamide , @ @ mmHg ; brimonidine , @ @ mmHg ) .


At month @ , BBFC lowered mean diurnal IOP from baseline to a significantly greater extent than brinzolamide ( least squares -LSB- LS -RSB- mean difference : -@ mmHg ; P < @ ; t test ) and brimonidine ( LS mean difference : -@ mmHg ; P < @ ) .


All supportive end points corroborated the results of the primary efficacy analysis .


Mean percentage reductions in IOP from baseline were @ % to @ % with BBFC , @ % to @ % with brinzolamide , and @ % to @ % with brimonidine .


The most common adverse drug reactions were ocular side effects , including hyperemia , blurred vision , allergic-type reactions , and discomfort .


The incidence of hyperemia of the eye was slightly lower with brinzolamide than with BBFC and brimonidine , whereas blurred vision and ocular discomfort were slightly more common with BBFC than with brinzolamide or brimonidine .


Brinzolamide @ % and brimonidine @ % fixed combination administered BID had a significantly greater IOP-lowering effect than either brinzolamide or brimonidine alone and displayed a safety profile consistent with its individual components .


Femoroacetabular impingement is a common cause of hip/groin symptoms and impaired functional performance in younger sporting populations and results from morphological abnormalities of the hip in which the proximal femur abuts against the acetabular rim .


Many people with symptomatic femoroacetabular impingement undergo arthroscopic hip surgery to correct the bony abnormalities .


While many case series over the past decade have reported favourable surgical outcomes , it is not known whether formal rehabilitation is needed as part of the management of patients undergoing this surgical procedure .


This randomised controlled trial will investigate the efficacy of a progressive physiotherapist-supervised rehabilitation program ( Takla-O'Donnell Protocol ) in improving health-related quality of life , physical function and symptoms in individuals undergoing arthroscopic management of femoroacetabular impingement .


@ people aged @-@ years undergoing hip arthroscopy for symptomatic femoroacetabular impingement will be recruited from surgical practices in Melbourne , Australia and randomly allocated to either a physiotherapy or control group .


Both groups will receive written information and one standardised post-operative physiotherapy visit whilst in hospital as per usual care .


Those in the physiotherapy group will also receive seven individual @-minute physiotherapy sessions , including one pre-operative visit ( within @ weeks of surgery ) and six post-operative visits at fortnightly intervals ( commencing two weeks after surgery ) .


The physiotherapy intervention will incorporate education and advice , manual techniques and prescription of a progressive rehabilitation program including home , aquatic and gym exercises .


The control group will not receive additional physiotherapy management .


Measurements will be taken at baseline ( @ weeks pre-operatively ) and at @ and @ weeks post-surgery .


Primary outcomes are the International Hip Outcome Tool and the sports subscale of the Hip Outcome Score at @ weeks post-surgery .


Secondary outcomes include the Copenhagen Hip and Groin Outcome Score , the activities of daily living subscale of the Hip Outcome Score , the Heidelberg Sports Activity Score , a modified Tegner Activity Scale and participant-perceived overall change .


The findings from this randomised controlled trial will provide evidence for the efficacy of a specific physiotherapist-supervised rehabilitation program in improving outcomes following arthroscopic management of symptomatic femoroacetabular impingement .


Injury prevention effects of neuromuscular training have been partly attributed to postural control adaptations .


Uncertainty exists regarding the magnitude of these adaptations and on how they can be adequately monitored .


The objective was to determine the time course of neuromuscular training effects on functional , dynamic and static balance measures .


Thirty youth ( @ @ years ) field hockey athletes were randomised to an intervention or control group .


The intervention included a @-min neuromuscular warm-up program performed twice weekly for @ weeks .


Balance assessments were performed at baseline , week three , week six and post-intervention .


They included the star excursion balance test ( SEBT ) , balance error scoring system ( BESS ) , jump-landing time to stabilization ( TTS ) and center of pressure ( COP ) sway velocity during single-leg standing .


No baseline differences were found between groups in demographic data and balance measures .


Adherence was at @ % .


All balance measures except the medial-lateral TTS improved significantly over time ( p < @ ) in both groups .


Significant group by time interactions were found for the BESS score ( p < @ ) .


The intervention group showed greater improvements ( @ @ % ) after @ weeks in comparison to controls ( @ @ % ) .


There were no significant group by time interactions in the SEBT , TTS and COP sway velocity .


Neuromuscular training was effective in improving postural control in youth team athletes .


However , this effect was not reflected in all balance measures suggesting that the neuromuscular training did not influence all dimensions of postural control .


Further studies are needed to confirm the potential of specific warm-up programs to improve postural control .


To evaluate the effect of monthly intravitreal ranibizumab on hard exudate ( HE ) area and the impact of HE on visual acuity ( VA ) outcomes in diabetic macular edema ( DME ) patients using data from @ phase III clinical trials .


Exploratory analyses of phase III , randomized , double-masked , sham-controlled , multicenter clinical trials .


Adults with DME , baseline best-corrected VA @/@ to @/@ Snellen equivalent , and central foveal thickness of @ m.


Between the @ studies , @ patients with DME were randomized to receive monthly @ or @ mg intravitreal ranibizumab ( Lucentis ; Genentech , Inc. , South San Francisco , CA ) or sham injections .


Hard exudate area was assessed from color fundus stereophotographs both on an ordinal scale and using continuous estimates of areas within the Early Treatment Diabetic Retinopathy Study grid .


Data from @ eyes were available for analysis .


Mean baseline HE area was similar across treatment groups , ranging from @ to @ mm ( @ ) .


Through month @ , the percentage of eyes without HE increased from @ % to @ % in the sham group and from @ % to @ % and @ % to @ % in the ranibizumab @-mg and @-mg groups , respectively .


Resolution of HE became apparent sometime after month @ in ranibizumab-treated eyes .


At baseline , there was no meaningful correlation between VA and presence or absence of HE .


After baseline , there also was no consistent correlation between presence or absence of HE and change in VA over time .


In this exploratory analysis , monthly intravitreal ranibizumab resulted in significantly greater reduction of HE area compared with sham ( P < @ ) .


In contrast to the rapid effects of ranibizumab on macular edema , changes in HE area were more gradual .


Contrary to prior expectations , the presence and area of HE did not increase as DME resolved ( either in the ranibizumab or sham groups ) .


Importantly , baseline VA was not correlated with presence of HE , nor was the therapeutic benefit of ranibizumab on VA affected negatively by the presence of HE .


These data suggest that in the context of intravitreal anti-vascular endothelial growth factor therapy , the presence of HE is not a prognostic indicator of poor visual outcomes .


This study aims to assess the extent to which accelerometers can be used to determine the effect of robot-supported task-oriented arm-hand training , relative to task-oriented arm-hand training alone , on the actual amount of arm-hand use of chronic stroke patients in their home situation .


This single-blind randomized controlled trial included @ chronic stroke patients , randomly allocated using blocked randomization ( n = @ ) to receive task-oriented robot-supported arm-hand training or task-oriented ( unsupported ) arm-hand training .


Training lasted @ weeks , @ times/week , @ @ min/day using the ( T - ) TOAT ( ( Technology-supported ) - Task-Oriented-Arm-Training ) method .


The actual amount of arm-hand use , was assessed at baseline , after @ weeks training and @ months after training cessation .


Duration of use and intensity of use of the affected arm-hand during unimanual and bimanual activities were calculated .


Duration and intensity of use of the affected arm-hand did not change significantly during and after training , with or without robot-support ( i.e. duration of use of unimanual use of the affected arm-hand : median difference of -@ % in the robot-group and -@ % in the control group between baseline and after training cessation ; intensity of the affected arm-hand : median difference of @ % in the robot-group and @ % in the control group between baseline and after training cessation ) .


No significant between-group differences were found .


Accelerometer data did not show significant changes in actual amount of arm-hand use after task-oriented training , with or without robot-support .


Next to the amount of use , discrimination between activities performed and information about quality of use of the affected arm-hand are essential to determine actual arm-hand performance .


Cancer survivorship rates have increased in developed countries largely due to population ageing and improvements in cancer care .


Survivorship is a neglected phase of cancer treatment and is often associated with adverse physical and psychological effects .


There is a need for broadly accessible , non-pharmacological measures that may prolong disease-free survival , reduce or alleviate co-morbidities and enhance quality of life .


The aim of the Steps TowaRd Improving Diet and Exercise ( STRIDE ) study is to evaluate the effectiveness of an online-delivered physical activity intervention for increasing walking in cancer survivors living in metropolitan and rural areas of South Australia .


This is a quasi-randomised controlled trial .


The intervention period is @-weeks with @-month follow-up .


The trial will be conducted at a university setting and community health services in South Australia .


Participants will be insufficiently active and aged @ years or older .


Participants will be randomly assigned to either the intervention or control group .


All participants will receive a pedometer but only the intervention group will have access to the STRIDE website where they will report steps , affect and ratings of perceived exertion ( RPE ) during exercise daily .


Researchers will use these variables to individualise weekly step goals to increase walking.The primary outcome measure is steps per day .


The secondary outcomes are a ) health measures ( anthropometric and physiological ) , b ) dietary habits ( consumption of core foods and non-core foods ) and c ) quality of life ( QOL ) including physical , psychological and social wellbeing .


Measures will be collected at baseline , post-intervention and @-month follow-up .


This protocol describes the implementation of a trial using an online resource to assist cancer survivors to become more physically active .


It is an innovative tool that uses ratings of perceived exertion and daily affect to create individualised step goals for cancer survivors .


The research findings may be of relevance to public health policy makers as an efficacious and inexpensive online-delivered intervention can have widespread application and may improve physical and psychological outcomes among this vulnerable population .


Findings may indicate directions for the implementation of future physical activity interventions with this population .


It was the aim of this study to evaluate maintenance therapy with bevacizumab + capecitabine following induction with bevacizumab + capecitabine + oxaliplatin ( XELOX ) versus bevacizumab + XELOX until progression as first-line therapy in metastatic colorectal cancer ( mCRC ) .


Patients received either bevacizumab ( @ mg/kg ) + XELOX ( capecitabine @,@ mg/m ( @ ) twice daily on days @-@ + oxaliplatin @ mg/m ( @ ) on day @ every @ weeks ) until disease progression ( arm A ) or the same doses of bevacizumab + XELOX for @ cycles followed by bevacizumab + capecitabine until disease progression ( arm B ) .


The primary endpoint was progression-free survival ( PFS ) ; secondary endpoints included overall survival ( OS ) , objective response rate ( ORR ) and safety .


One hundred and twenty-three patients were randomized .


Treatment compliance was similar in both groups .


Median PFS was significantly longer for arm B than for arm A ( @ vs. @ months ; p = @ ) .


There was no significant difference between the two arms for ORR ( @ vs. @ % ; p = @ ) or median OS ( @ vs. @ months ; p = @ ) .


Tolerability was acceptable in both treatment arms ; the most frequent grade @/@ treatment-related adverse events ( arm B vs. arm A ) were fatigue ( @ vs. @ % ) , diarrhoea ( @ vs. @ % ) , anorexia ( @ vs. @ % ) , and neuropathy ( @ vs. @ % ) .


Maintenance therapy with bevacizumab + capecitabine can be considered an appropriate option following induction bevacizumab + XELOX in patients with mCRC instead of continuation of bevacizumab + XELOX .


The aim of the present study was to compare the frequency of readmissions due to small bowel obstruction ( SBO ) after open versus laparoscopic surgery performed for suspected acute appendicitis .


Appendicitis is a common disease , with a lifetime risk of approximately @ % .


Appendectomy is the treatment of choice for most patients .


Postoperative adhesions are common after abdominal surgery , including appendectomy .


Consecutive patients , @ years or older , operated on because of suspected appendicitis at @ university hospitals between @ and @ were included .


The prime approach was open at one hospital and laparoscopic at the other hospital .


Open and laparoscopic procedures were compared retrospectively , reviewing the patients ' charts until the middle of @ .


Hospitalization for SBO after index surgery was registered .


A total of @ patients in the open group and @ patients in the laparoscopic group were included .


The frequency of hospitalization for SBO was low in both groups , although a difference between the groups was identified ( @ % in the open group and @ % in the laparoscopic group ) ( P = @ ) .


Hospitalization due to SBO , between open and laparoscopic procedures , in patients operated on because of suspected appendicitis demonstrated a significant difference , favoring the laparoscopic approach .


The frequency of SBO after the index surgery was , though , low in both groups .


Behavioral approaches and pharmacotherapy are of proven benefit in assisting smokers to quit , but it is unclear whether combining nicotine replacement therapy ( NRT ) with varenicline to improve abstinence is effective and safe .


To evaluate the efficacy and safety of combining varenicline and a nicotine patch vs varenicline alone in smoking cessation .


Randomized , blinded , placebo-controlled clinical trial with a @-week treatment period and a further @-week follow-up conducted in @ centers in South Africa from April @ to October @ .


Four hundred forty-six generally healthy smokers were randomized ( @:@ ) ; @ were included in the efficacy and safety analyses .


Nicotine or placebo patch treatment began @ weeks before a target quit date ( TQD ) and continued for a further @ weeks .


Varenicline was begun @ week prior to TQD , continued for a further @ weeks , and tapered off during week @ .


Tobacco abstinence was established and confirmed by exhaled carbon monoxide measurements at TQD and at intervals thereafter up to @ weeks .


The primary end point was the @-week exhaled carbon monoxide-confirmed continuous abstinence rate for weeks @ through @ of treatment , ie , the proportion of participants able to maintain complete abstinence from smoking for the last @ weeks of treatment , as assessed using multiple imputation analysis .


Secondary end points included point prevalence abstinence at @ months , continuous abstinence rate from weeks @ through @ , and adverse events .


Multiple imputation also was used to address loss to follow-up .


The combination treatment was associated with a higher continuous abstinence rate at @ weeks ( @ % vs @ % ; odds ratio -LSB- OR -RSB- , @ ; @ % CI , @-@ @ ; P = @ ) and @ weeks ( @ % vs @ % ; OR , @ ; @ % CI , @-@ @ ; P = @ ) and point prevalence abstinence rate at @ months ( @ % vs @ % ; OR , @ ; @ % CI , @-@ @ ; P = @ ) .


In the combination treatment group , there was a numerically greater incidence of nausea , sleep disturbance , skin reactions , constipation , and depression , with only skin reactions reaching statistical significance ( @ % vs @ % ; P = @ ) ; the varenicline-alone group experienced more abnormal dreams and headaches .


Varenicline in combination with NRT was more effective than varenicline alone at achieving tobacco abstinence at @ weeks ( end of treatment ) and at @ months .


Further studies are needed to assess long-term efficacy and safety .


Intensive care unit ( ICU ) - acquired weakness is a frequent complication of critical illness .


It is unclear whether it is a marker or mediator of poor outcomes .


To determine acute outcomes , @-year mortality , and costs of ICU-acquired weakness among long-stay ( @ d ) ICU patients and to assess the impact of recovery of weakness at ICU discharge .


Data were prospectively collected during a randomized controlled trial .


Impact of weakness on outcomes and costs was analyzed with a one-to-one propensity-score-matching for baseline characteristics , illness severity , and risk factor exposure before assessment .


Among weak patients , impact of persistent weakness at ICU discharge on risk of death after @ year was examined with multivariable Cox proportional hazards analysis .


A total of @ % were admitted to the surgical ICU ; @ of @ ( @ % ) long-stay assessable ICU patients were weak ; @ weak patients were matched to @ not-weak patients .


As compared with matched not-weak patients , weak patients had a lower likelihood for live weaning from mechanical ventilation ( hazard ratio -LSB- HR -RSB- , @ -LSB- @-@ @ -RSB- ; P = @ ) , live ICU ( HR , @ -LSB- @-@ @ -RSB- ; P = @ ) and hospital discharge ( HR , @ -LSB- @-@ @ -RSB- ; P = @ ) .


In-hospital costs per patient ( +@ % , +@,@ Euro per patient ; P = @ ) and @-year mortality ( @ % vs. @ % ; P = @ ) were also higher .


The @ of @ ( @ % ) weak patients not matchable to not-weak patients had even worse prognosis and higher costs .


The @-year risk of death was further increased if weakness persisted and was more severe as compared with recovery of weakness at ICU discharge ( P < @ ) .


After careful matching the data suggest that ICU-acquired weakness worsens acute morbidity and increases healthcare-related costs and @-year mortality .


Persistence and severity of weakness at ICU discharge further increased @-year mortality .


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


As parents of young children are often unaware their child is overweight , screening provides the opportunity to inform parents and provide the impetus for behaviour change .


We aimed to determine if parents could recall and understand the information they received about their overweight child after weight screening .


Randomised controlled trial of different methods of feedback .


Participants were recruited through primary and secondary care but appointments took place at a University research clinic .


@ children aged @-@years were screened .


Only overweight children ( n = @ , @ % ) are included in this study .


Parents of overweight children were randomised to receive feedback regarding their child 's weight using best practice care ( BPC ) or motivational interviewing ( MI ) at face-to-face interviews typically lasting @-@min .


@ ( @ % ) parents participated in a follow-up interview @weeks later to assess recall and understanding of information from the feedback session .


Interviews were audio-taped and transcribed verbatim before coding for amount and accuracy of recall .


Scores were calculated for total recall and sub-categories of interest .


Overall , @ % of the information was recalled ( mean score @ from possible score of @ ) .


Parents given feedback via BPC recalled more than those in the MI group ( difference in total score @ ; @ % CI @ to @ ) .


Although @ % of parents were able to correctly recall their child 's weight status , fewer than @ parents could accurately describe what the measurements meant .


Maternal education ( @ ; @ to @ ) and parental ratings of how useful they found the information ( @ ; @ to @ ) were significant predictors of recall score in multivariate analyses .


While parents remember that their child 's body mass index is higher than recommended , they are unable to remember much of the information and advice provided about the result .


The limitations of antipsychotic therapy in schizophrenia and schizoaffective disorder led to the investigation of the putative utility of pharmacologic augmentation strategies .


The antitumor agent bexarotene via nuclear retinoid X receptor ( RXR ) activation might modulate numerous metabolic pathways involved in the pathogenesis of schizophrenia and schizoaffective disorder .


This trial aimed to investigate efficacy and safety of add-on bexarotene to ongoing antipsychotic treatment of patients with schizophrenia or schizoaffective disorder .


Ninety inpatients and outpatients that met DSM-IV-TR criteria for schizophrenia or schizoaffective disorder participated in a @-week , double-blind , randomized , placebo-controlled multicenter study .


Bexarotene ( @ mg/d ) was added to ongoing antipsychotic treatment from October @ to December @ .


The reduction in the severity of symptoms on the Positive and Negative Syndrome Scale ( PANSS ) was a primary outcome .


Secondary outcomes included general functioning , quality of life , and side effect scales .


Seventy-nine participants ( @ % ) completed the protocol .


Controlling for antipsychotic agents , a mixed model showed that patients who received adjunctive bexarotene had significantly lower PANSS positive scale scores compared to patients who received placebo ( F = @ , P = @ ; treatment arms time , F = @ , P = @ ) , with moderate effect size ( d = @ ; @ % CI,@-@ @ ) .


Patients with mean or higher baseline PANSS positive scale scores and patients who did not take lipid-reducing agents revealed greater amelioration of positive symptoms ( F = @ , P = @ ) .


Other symptoms and secondary outcome measures were not affected by adjunctive bexarotene .


Bexarotene was well tolerated , though @ reversible side effects were reported : a significant increase in total cholesterol levels ( P < @ ) and a decrease in total thyroxine levels ( P < @ ) .


Bexarotene might potentially be a novel adjuvant therapeutic strategy for schizophrenia , particularly for the reduction of positive symptoms .


The potential benefits and risks of ongoing administration of bexarotene warrant further evaluation .


The clinical utility of genotype-guided ( pharmacogenetically based ) dosing of warfarin has been tested only in small clinical trials or observational studies , with equivocal results .


We randomly assigned @ patients to receive doses of warfarin during the first @ days of therapy that were determined according to a dosing algorithm that included both clinical variables and genotype data or to one that included clinical variables only .


All patients and clinicians were unaware of the dose of warfarin during the first @ weeks of therapy .


The primary outcome was the percentage of time that the international normalized ratio ( INR ) was in the therapeutic range from day @ or @ through day @ of therapy .


At @ weeks , the mean percentage of time in the therapeutic range was @ % in the genotype-guided group and @ % in the clinically guided group ( adjusted mean difference , -LSB- genotype-guided group minus clinically guided group -RSB- , -@ ; @ % confidence interval , -@ to @ ; P = @ ) .


There also was no significant between-group difference among patients with a predicted dose difference between the two algorithms of @ mg per day or more .


There was , however , a significant interaction between dosing strategy and race ( P = @ ) .


Among black patients , the mean percentage of time in the therapeutic range was less in the genotype-guided group than in the clinically guided group .


The rates of the combined outcome of any INR of @ or more , major bleeding , or thromboembolism did not differ significantly according to dosing strategy .


Genotype-guided dosing of warfarin did not improve anticoagulation control during the first @ weeks of therapy .


( Funded by the National Heart , Lung , and Blood Institute and others ; COAG ClinicalTrials.gov number , NCT@ . )


Calcium supplements are widely used among older adults for osteoporosis prevention and treatment .


However , their effect on creatinine levels and kidney function has not been well studied .


We investigated the effect of calcium supplementation on blood creatinine concentration in a randomized controlled trial of colorectal adenoma chemoprevention conducted between @-@ at @ clinical centers in the United States .


Healthy participants ( N = @,@ ) aged @-@ with a history of colorectal adenoma were assigned to daily supplementation with calcium ( @ mg , as carbonate ) , vitamin D@ ( @ IU ) , both , or placebo for three or five years .


Changes in blood creatinine and total calcium concentration were measured after one year of treatment and multiple linear regression was used to estimate effects on creatinine concentrations .


After one year of treatment , blood creatinine was @ mg/dL higher on average among participants randomized to calcium compared to placebo after adjustment for other determinants of creatinine ( P = @ ) .


However , the effect of calcium treatment appeared to be larger among participants who consumed the most alcohol ( @-@ drinks/day ) or whose estimated glomerular filtration rate ( eGFR ) was less than @ ml/min/@ @ m@ at baseline .


The effect of calcium treatment on creatinine was only partially mediated by a concomitant increase in blood total calcium concentration and was independent of randomized vitamin D treatment .


There did not appear to be further increases in creatinine after the first year of calcium treatment .


Among healthy adults participating in a randomized clinical trial , daily supplementation with @ mg of elemental calcium caused a small increase in blood creatinine .


If confirmed , this finding may have implications for clinical and public health recommendations for calcium supplementation .


Example-based learning using worked examples can foster clinical reasoning .


Worked examples are instructional tools that learners can use to study the steps needed to solve a problem .


Studying worked examples paired with completion examples promotes acquisition of problem-solving skills more than studying worked examples alone .


Completion examples are worked examples in which some of the solution steps remain unsolved for learners to complete .


Providing learners engaged in example-based learning with self-explanation prompts has been shown to foster increased meaningful learning compared to providing no self-explanation prompts .


Concept mapping and concept map study are other instructional activities known to promote meaningful learning .


This study compares the effects of self-explaining , completing a concept map and studying a concept map on conceptual knowledge and problem-solving skills among novice learners engaged in example-based learning .


Ninety-one physiotherapy students were randomized into three conditions .


They performed a pre-test and a post-test to evaluate their gains in conceptual knowledge and problem-solving skills ( transfer performance ) in intervention selection .


They studied three pairs of worked/completion examples in a digital learning environment .


Worked examples consisted of a written reasoning process for selecting an optimal physiotherapy intervention for a patient .


The completion examples were partially worked out , with the last few problem-solving steps left blank for students to complete .


The students then had to engage in additional self-explanation , concept map completion or model concept map study in order to synthesize and deepen their knowledge of the key concepts and problem-solving steps .


Pre-test performance did not differ among conditions .


Post-test conceptual knowledge was higher ( P < @ ) in the concept map study condition ( @ % ) compared to the concept map completion ( @ % ) and self-explanation ( @ % ) conditions .


Post-test problem-solving performance was higher ( P < @ ) in the self-explanation ( @ % ) condition compared to the concept map study ( @ % ) and concept map completion ( @ % ) conditions .


Students in the self-explanation condition also invested less mental effort in the post-test .


Studying model concept maps led to greater conceptual knowledge , whereas self-explanation led to higher transfer performance .


Self-explanation and concept map study can be combined with worked example and completion example strategies to foster intervention selection .


To evaluate the effectiveness and safety of nitrous oxide/oxygen inhalation sedation in the treatment of acute pulpitis .


The study population comprised @ patients of acute pulpitis treated from September @ to March @ .


They were randomly divided into @ groups , which included experimental group ( @ cases ) and control group ( @ cases ) .


Venham clinical anxiety , cooperative behavior level and WHO clinical pain level evaluation were conducted for the patients .


Wilcoxon and Chi-square test were used respectively for statistical analysis with SPSS @ software package .


In the experimental group , @ % cases behaved comfortable , while in the control group the rate was only @ % .


@ % of the patients in the experimental group felt painless after therapy .


The proportion of that in the control group was @ % .


There was significant difference between the @ groups ( P < @ ) .


The technique of nitrous oxide/oxygen inhalation sedation provides a safe and effective way to release pain and anxiety during treatment of acute pulpitis , while the long-term clinical result still needs further investigation .


To observe the influence of moxibustion temperature on blood lipids , endothelin-@ ( ET-@ ) , nitric oxide ( NO ) , and ET-@ / NO in hyperlipidemia patients .


Forty-two primary hyperlipidemia patients were randomly divided into two groups of @ and treated with moxibustion at different temperatures .


Moxibustion was performed with the moxa roll @-@ @ cm from the skin in the treatment group and @ cm in the control group , @ min per point , once every other day .


Skin temperature was precisely measured with a thermometer during moxibustion .


After a @-week treatment , seven measurements of blood lipids , ET-@ , and NO were recorded .


Total cholesterol and triglyceride , were lower in the treatment group than in the control group ( P < @ ) .


Serum ET-@ and ET-@ / NO was obviously lowered in the treatment group ( P < @ ) .


Moxibustion regulated NO and ET-@ / NO in the treatment group much better than in the control group .


Moxibustion can regulate blood lipids and clear blood vessels .


Moxibustion at @ degrees C has a better effect than moxibustion at @ degrees C on regulating blood lipids and protecting vascular endothelial function , indicating that suitable temperature influences the curative effect of moxibustion .


In @ , we began the randomised phase @ multicentre HYPRO trial to investigate the effect of hypofractionated radiotherapy compared with conventionally fractionated radiotherapy on relapse-free survival in patients with prostate cancer .


Here , we examine whether patients experience differences in acute gastrointestinal and genitourinary adverse effects .


In this randomised non-inferiority phase @ trial , done in seven radiotherapy centres in the Netherlands , we enrolled intermediate-risk or high-risk patients aged between @ and @ years with histologically confirmed stage T@b-T@ NX-@MX-@ prostate cancer , a PSA concentration of @ ng/mL or lower , and WHO performance status of @-@ .


A web-based application was used to randomly assign ( @:@ ) patients to receive either standard fractionation with @ fractions of @ Gy in @ weeks ( five fractions per week ) or hypofractionation with @ fractions of @ Gy in @ weeks ( three fractions per week ) .


Randomisation was done with minimisation procedure , stratified by treatment centre and risk group .


The primary endpoint is @-year relapse-free survival .


Here we report data for the acute toxicity outcomes : the cumulative incidence of grade @ or worse acute and late genitourinary and gastrointestinal toxicity .


Non-inferiority of hypofractionation was tested separately for genitourinary and gastrointestinal acute toxic effects , with a null hypothesis that cumulative incidences of each type of adverse event were not more than @ % higher in the hypofractionation group than in the standard fractionation group .


We scored acute genitourinary and gastrointestinal toxic effects according to RTOG-EORTC criteria from both case report forms and patients ' self-assessment questionnaires , at baseline , twice during radiotherapy , and @ months after completion of radiotherapy .


Analyses were done in the intention-to-treat population .


Patient recruitment has been completed .


This study is registered with www.controlled-trials.com , number ISRCTN@ .


Between March @ , @ , and Dec @ , @ , @ patients were randomly assigned to treatment with standard fractionation ( n = @ ) or hypofractionation ( n = @ ) .


@ months after radiotherapy , @ ( @ % ) patients in the standard fractionation group and @ ( @ % ) patients in the hypofractionation group reported grade @ or worse genitourinary toxicity ; grade @ or worse gastrointestinal toxicity was noted in @ ( @ % ) patients in the standard fractionation group and in @ ( @ % ) in the hypofractionation group .


Grade @ acute genitourinary toxicity was reported for two patients , one ( < @ % ) in each group .


No grade @ acute gastrointestinal toxicities were observed .


We noted no significant difference in cumulative incidence by @ days after radiotherapy of grade @ or worse acute genitourinary toxicity ( @ % -LSB- @ % CI @-@ -RSB- in the standard fractionation group vs @ % ( @-@ ) in the hypofractionation group ; difference @ % , @ % CI -@ to @ ; odds ratio -LSB- OR -RSB- @ , @ % CI @-@ ; p = @ ) .


The cumulative incidence of grade @ or worse acute gastrointestinal toxicity by @ days after radiotherapy was higher in patients given hypofractionation ( @ % -LSB- @ % CI @-@ -RSB- in the standard fractionation group vs @ % -LSB- @-@ -RSB- in the hypofractionation group ; difference @ % , @ % CI @-@ ; OR @ ; p = @ ; non-inferiority not confirmed ) .


Hypofractionated radiotherapy was not non-inferior to standard fractionated radiotherapy in terms of acute genitourinary and gastrointestinal toxicity for men with intermediate-risk and high-risk prostate cancer .


In fact , the cumulative incidence of grade @ or worse acute gastrointestinal toxicity was significantly higher in patients given hypofractionation than in those given standard fractionated radiotherapy .


Patients remain in follow-up for efficacy endpoints .


To compare the outcome in patients who underwent surgery for unstable intertrochanteric femoral fractures using the proximal femoral locking plate versus the dynamic hip screw ( DHS ) .


@ men and @ women aged @ to @ ( mean , @ ) years were randomised to the proximal femoral locking plate group , whereas @ men and @ women aged @ to @ ( mean , @ ) years were randomised to the conventional @-degree DHS group .


The time to union , medialisation of the shaft , neck-shaft angle , limb shortening , varus collapse , and functional outcome ( using the Hospital for Special Surgery Hip Rating System ) were assessed .


Respectively in the locking plate and DHS groups , the mean times to union were @ and @ weeks ( p = @ ) and the mean limb shortenings were @ and @ cm ( p < @ ) .


Medialisation of the shaft occurred in @ and @ patients ( p < @ ) ; varus collapse occurred in @ and @ patients ( p = @ ) ; the functional hip score was good-to-excellent in @ and @ patients ( p = @ ) ; deep wound infection occurred in @ and @ patients ; and implant cut-out occurred in one patient each group .


A non-collapsing locking plate achieved bone union in unstable intertrochanteric fractures with lower risks of limb shortening and medialisation of the shaft .


The @ fusion of lumbar segments is a common and well-researched therapy to treat various diseases of the spine .


But it changes the biomechanics of the spine and may cause adjacent segment disease ( ASD ) .


Among the many techniques developed to avoid this complication , one appears promising .


It combines a rigid fusion with a flexible pedicle screw system ( hybrid instrumentation , `` topping off '' ) .


However , its clinical significance is still uncertain due to the lack of conclusive data .


The study is a randomized , therapy-controlled , two-centre trial conducted in a clinical setting at two university hospitals .


If they meet the criteria , outpatients presenting with degenerative disc disease , facet joint arthrosis or spondylolisthesis will be included in the study and randomized into two groups : a control group undergoing conventional fusion surgery ( PLIF - posterior lumbar intervertebral fusion ) , and an intervention group undergoing fusion surgery using a new flexible pedicle screw system ( PLIF + `` topping off '' ) , which was brought on the market in @ .


Follow-up examination will take place immediately after surgery , after @ weeks and after @ , @ , @ and @ months .


An ongoing assessment will be performed every year.Outcome measurements will include quality of life and pain assessments using validated questionnaires ( ODI - Ostwestry Disability Index , SF-@ - Short Form Health Survey @ , COMI - Core Outcome Measure Index ) .


In addition , clinical and radiologic ASD , sagittal balance parameters and duration of work disability will be assessed .


Inpatient and @-month mortality , surgery-related data ( e.g. , intraoperative complications , blood loss , length of incision , surgical duration ) , postoperative complications ( e.g. implant failure ) , adverse events , and serious adverse events will be monitored and documented throughout the study .


New hybrid `` topping off '' systems might improve the outcome of lumbar spine fusion .


But to date , there is a serious lack of and a great need of convincing data on safety or efficacy , including benefits and harms to the patients , of these systems .


Health care providers are particularly interested in such data as these implants are much more expensive than conventional implants .


In such a case , randomized clinical trials are the best way to evaluate benefits and risks .


There is insufficient evidence of a relationship between acupuncture needle sensations ( de qi ) and hypoalgesia .


The aim of this study was to investigate the effects of bidirectional needle rotation at LI@ on acupuncture needle sensations and heat pain thresholds .


Twenty-two healthy participants received one acupuncture needle at LI@ with bidirectional rotation of the needle in one experimental session and one acupuncture needle at LI@ with mock rotation in a separate session , in a randomised order .


Measurements of heat pain thresholds were taken before needle insertion , during needle retention and @min after needle removal .


At each measurement time point , participants rated needle sensations using the Massachusetts Acupuncture Sensation Scale ( MASS ) and a visual analogue scale ( VAS ) of overall intensity of needle sensation .


Bidirectional needle rotation produced significantly higher scores for VAS , MASStotal , MASSpain and MASSsensation compared with mock rotation ( all p < @ ) .


There were significantly higher pain thresholds relative to pre-intervention baseline during ( p = @ ) and after ( p < @ ) bidirectional needle rotation but not during ( p = @ ) or after ( p = @ ) mock bidirectional needle rotation .


Bidirectional needle rotation increased the pain threshold relative to baseline @min after the needles were removed ( p = @ ) .


A significant but low correlation between needle sensation and change in pain threshold after needling was only found when data from mock and rotation interventions were combined .


Needle rotation increases the magnitude of hypoalgesia .


There is tentative evidence that needle sensation may be associated with the amount of change in pain threshold .


This study investigated the relationship of gratitude to wisdom .


Both constructs are conceptually related to self-reflectivity , but they differ in their emphasis on extrapersonal resources .


Previous wisdom research has focused mainly on intrapersonal capacities .


In Study @ , @ wisdom nominees and @ control participants were interviewed about their most difficult and best life event and filled out a questionnaire on sources of gratitude .


Study @ was a quantitative study ( N = @ ) of the relationship between a wisdom scale and scale measures and individual sources of gratitude .


Significantly more wisdom nominees expressed feelings of gratitude spontaneously in their interview .


Wisdom nominees reported gratitude for their life in general , religion , and partner more often than control participants .


In Study @ , wisdom was related to all gratitude scales and to similar sources of gratitude as in Study @ .


Both studies found gender differences in gratitude but not wisdom .


Two important implications of these findings are that wisdom entails an appreciation of life and its experiences , especially the growth opportunities that may result from negative events , and that there may be substantial differences between male and female pathways to wisdom .