Further adjustment for changes in patient characteristics between periods , including the addition of asymptomatic patients and a > @ % decrease in proportion of octogenarians enrolled , resulted in practically identical rates .


Evidence linking extreme response style ( ER ) to depressive relapse has been mixed .


One reason might be high levels of extreme responses that are positive in nature ( ER-Ps ) compared with those negative in nature ( ER-Ns ) at posttreatment .


ER-Ps likely consist of both maladaptive `` style '' responses and adaptive `` content '' responses ( i.e. , legitimate denials of dysfunction ) .


The composition of ER-Ps might confound measures of total extreme responding as well as conventional scores on cognitive questionnaires .


In the current study , we assessed ER in a new sample by ( a ) disambiguating ER-Ps that reflect style from those that reflect content and ( b ) assessing the contribution of ER-Ps to the prediction of relapse/recurrence .


Responders ( N = @ ) to a randomized controlled trial of cognitive therapy versus medications for moderate to severe depression had an average age of @ years ( SD = @ ) , and they were @ % female , @ % married/cohabitating , and @ % Caucasian .


ER variables were calculated using the Dysfunctional Attitudes Scale ( DAS ; Weissman , @ ) , with ER-Ps categorized as either content or style responses .


ER indices and DAS scores were used to predict symptom return over @ years .


No standard extreme responding variables ( e.g. , an index of total extreme responding ) predicted symptom return , but higher relative levels of style ER-P predicted relapse/recurrence .


Total DAS scores also predicted relapse/recurrence but only when high levels of style ER-P responses were controlled .


ER-Ps , at least on the DAS , appear to contain indicators of both adaptive and maladaptive positive responses .


Future research should attend to the valence of the extreme responses as well as to the content of extreme positive responses , which may reflect either healthy or unhealthy tendencies .


Recent evidence supports the efficacy of programs that promote improvements in the health practices of workers @ years and older who are at higher risk for chronic diseases than younger workers are .


Internet-based programs that promote healthy practices have also shown promise and , therefore , should be especially appropriate for workers aged @ years and older .


The purpose of the research was to evaluate the effectiveness of HealthyPast@ , a fully automated Web-based health promotion program based on social cognitive theory and aimed specifically at workers @ years and older .


The randomized controlled trial was conducted across multiple US offices of a large global information technology company .


The sample included @ employees aged @ to @ who were recruited online and randomly assigned to the Web-based HealthyPast@ program or to a wait-list control condition .


Self-report measures of diet , physical activity , stress , and tobacco use were collected online before and @ months after the program group was given access to the program .


Use data included number of log-ins and number of pages accessed .


The primary analysis was multiple linear regression , following intent-to-treat principles with multiple imputation using the Markov chain Monte Carlo ( MCMC ) approach for nonmonotone missing data .


Potential moderators from demographic characteristics and program dosage effects were assessed using multiple linear regression models .


Additional analyses were conducted on complete ( nonimputed ) cases , excluding program participants who used the program for less than @ minutes .


Retention rates were good for both groups : @ % ( @/@ ) for the program group and @ % ( @/@ ) for the control group .


Program group participants spent a mean of @ minutes in the program ( SD @ ) , logged in a mean of @ times ( SD @ ) , and viewed a mean of @ pages ( SD @ ) .


In the analysis of the imputed dataset , the program group performed significantly better than the control group on diet behavioral change self-efficacy ( estimated adjusted difference -LSB- -RSB- = @ , P = @ ) , planning healthy eating ( = @ , P = @ ) , and mild exercise ( = @ , P = @ ) .


Moderator and dosage analyses of the dataset found no significant program effects .


Analyses of the nonimputed dataset comparing program users with controls found additional significant program effects on eating practices ( = @ , P = @ ) , exercise self-efficacy ( = @ , P = @ ) , exercise planning ( = @ , P = @ ) , and aging beliefs ( = @ , P = @ ) .


Moderator analysis of this dataset also found significant moderator effects of gender on multiple measures of exercise .


A Web-based health promotion program showed promise for making a significant contribution to the short-term dietary and exercise practices of older working adults .


Gender effects suggest that the program effects on exercise are due mainly to improvements among women .


To evaluate the presence of spinal inflammation with and without sacroiliac ( SI ) joint inflammation on magnetic resonance imaging ( MRI ) in patients with active nonradiographic axial spondyloarthritis ( SpA ) , and to compare the disease characteristics of these subgroups .


ABILITY-@ is a multicenter , randomized , controlled trial of adalimumab versus placebo in patients with nonradiographic axial SpA classified using the Assessment of SpondyloArthritis international Society axial SpA criteria .


Baseline MRIs were centrally scored independently by @ readers using the Spondyloarthritis Research Consortium of Canada ( SPARCC ) method for the SI joints and the SPARCC @-discovertebral unit method for the spine .


Positive evidence of inflammation on MRI was defined as a SPARCC score of @ for either the SI joints or the spine .


Among patients with baseline SPARCC scores , @ % had an SI joint score of @ and @ % had a spine score of @ .


Forty-nine percent of patients with baseline SI joint scores of < @ , and @ % of those with baseline SI joint scores of @ , had a spine score of @ .


Comparison of baseline disease characteristics by baseline SI joint and spine scores showed that a greater proportion of patients in the subgroup with a baseline SPARCC score of @ for both SI joints and spine were male , and patients with spine and SI joint scores of < @ were younger and had shorter symptom duration .


SPARCC spine scores correlated with baseline symptom duration , and SI joint scores correlated negatively with the baseline Bath Ankylosing Spondylitis Disease Activity Index , but neither correlated with the baseline Ankylosing Spondylitis Disease Activity Score , total back pain , the patient 's global assessment of disease activity , the Bath Ankylosing Spondylitis Functional Index , morning stiffness , nocturnal pain , or C-reactive protein level .


Assessment by experienced readers showed that spinal inflammation on MRI might be observed in half of patients with nonradiographic axial SpA without SI joint inflammation .


To evaluate the effect of Clinpro XT Varnish ( VXT ) paste-liquid , resin-modified glass-ionomer and the resinous dentin desensitizing varnish and Gluma Dentin Desensitizer ( Gluma ) in treating dentin hypersensitivity ( DH ) .


This short-term ( @-week ) randomized , double-blind , placebo-controlled , split-mouth study included a total of @ teeth from @ individuals which were randomized into three groups : VXT , Gluma , and placebo ( warm water ) .


Dentin sensitivity was evaluated by subjects ' perception of DH determined by pretreatment tooth sensitivity score ( TSS ) measured on a @-@ visual analogue scale ( VAS ) after tactile ( probe ) or thermal/evaporative ( blast of air ) stimuli .


TSS was scored at baseline , immediately after treatment ( Day @ ) , after @ week and after @ weeks .


For both stimuli , mean TSS was significantly decreased in the VXT and Gluma groups at all time points ( all , P < @ ) compared with baseline .


Regarding comparisons of TSS between treatment groups , the VXT group had significantly lower mean TSS compared with the Gluma group ( P < @ ) and placebo control group ( P < @ ) at all time points after treatment regardless of stimuli .


Group Effect , Time Effect , and Group x Time Effect were all significantly different ( all , P < @ ) .


The outcomes of double-bundle anterior cruciate ligament reconstruction ( DB-ACLR ) are becoming controversial .


One of the main reasons for the controversy is the techniques for bone tunnel placement .


The common technique to place the bone tunnels is to use bony landmarks , while a new approach uses footprint remnants .


To investigate if placement of double tunnels using bony landmarks produces the same clinical results as that of using existing footprint remnants .


Randomized controlled trial ; Level of evidence , @ .


A total of @ male patients were randomly divided into @ groups of @ patients each : ( A ) DB-ACLR tunnel placement using the footprint remnant procedure ( EF group ) and ( B ) DB-ACLR tunnel placement using the bony landmark procedure ( BL group ) .


All patients were evaluated before and after surgery .


Outcomes were measured by KT-@ arthrometer side-to-side difference , pivot-shift test , and Tegner , Lysholm , and International Knee Documentation Committee ( IKDC ) scores .


Second-look arthroscopic evaluations were performed in @ cases ( @ and @ cases in the EF and BL groups , respectively ) .


The mean follow-up time was @ months .


Postoperative @-dimensional computed tomography scans showed that bone sockets were variable on both femoral and tibial sides in the EF group and almost consistent in the BL group .


All of the evaluation indexes were significantly improved postoperatively in both groups .


There were no revision cases in the EF group and @ in the BL group .


The EF group showed a faster range of motion ( ROM ) recovery ( at @ to @ ) than did the BL group .


At final follow-up , there was no significant difference between the EF and BL groups in Tegner score ( @ vs @ ; P = @ ) or pivot-shift test ( @ vs @ ; P = @ ) .


The EF group had a larger proportion of patients with IKDC grade A ( normal ) ( @ vs @ ; P < @ ) , smaller side-to-side difference ( @ mm vs @ mm ; P < @ ) , higher Lysholm score ( @ vs @ ; P = @ ) , and better second-look arthroscopic evaluations for graft quality in the anteromedial ( P = @ ) , posterolateral ( P = @ ) , and combined bundles ( P = @ ) compared with the BL group .


Although both techniques provided satisfactory clinical results , DB-ACLR using the existing footprint remnant for tunnel placement showed better functional results with respect to faster ROM recovery , higher subjective outcome scores , and better arthroscopic second-look with no revision cases .


This study sought to investigate the effect of a multiple micronutrient supplement on left ventricular ejection fraction ( LVEF ) in patients with heart failure .


Observational studies suggest that patients with heart failure have reduced intake and lower concentrations of a number of micronutrients .


However , there have been very few intervention studies investigating the effect of micronutrient supplementation in patients with heart failure .


This was a randomized , double-blind , placebo-controlled , parallel-group study involving @ patients with chronic stable heart failure that compared multiple micronutrient supplementation taken once daily versus placebo for @ months .


The primary endpoint was LVEF assessed by cardiovascular magnetic resonance imaging or @-dimensional echocardiography .


Secondary endpoints were Minnesota Living With Heart Failure Questionnaire score , @-min walk test distance , blood concentrations of N-terminal prohormone of brain natriuretic peptide , C-reactive protein , tumor necrosis factor alpha , interleukin-@ , interleukin-@ , and urinary levels of @-iso-prostaglandin F@ alpha .


Blood concentrations of a number of micronutrients increased significantly in the micronutrient supplement group , indicating excellent compliance with the intervention .


There was no significant difference in mean LVEF at @ months between treatment groups after adjusting for baseline ( mean difference : @ % , @ % confidence interval : -@ to @ , p = @ ) .


There was also no significant difference in any of the secondary endpoints at @ months between treatment groups .


This study provides no evidence to support the routine treatment of patients with chronic stable heart failure with a multiple micronutrient supplement .


( Micronutrient Supplementation in Patients With Heart Failure -LSB- MINT-HF -RSB- ; NCT@ ) .


Metformin is suggested to reduce pregnancy complications in women with polycystic ovary syndrome ( PCOS ) .


Metformin crosses the placenta and therapeutic concentrations are measured in the fetal circulation .


Whether metformin treatment in pregnant PCOS women affects maternal and fetal insulin concentrations at birth is not clarified .


To investigate the possible effect of metformin on insulin concentrations in umbilical cord blood and the possible association between maternal and fetal insulin concentrations .


Post-hoc analysis of a subgroup of PCOS women participating in a double-blind randomized controlled trial .


University hospital setting .


Women with PCOS ( n = @ ) , aged @-@ years .


Maternal and umbilical cord insulin concentrations immediately after birth .


At delivery women randomized to metformin had lower insulin concentrations than those randomized to placebo ( @ vs @pmol/l ; P = @ ) .


No difference was found in insulin concentrations in umbilical venous ( P = @ ) and arterial ( P = @ ) blood between the metformin and placebo groups .


The arteriovenous difference was also equal between the groups ( P = @ ) .


Insulin concentrations were higher in the umbilical vein than in the umbilical artery independent of randomization ( @ vs @pmol/l ; P < @ ) .


In PCOS , metformin treatment during pregnancy resulted in lower maternal insulin concentrations at delivery .


Metformin treatment did not affect fetal insulin concentrations .


Higher insulin concentrations in the umbilical vein indicate that the placenta somehow secretes insulin to the fetus .


The possibility of placental insulin secretion to the fetus deserves further investigations .


Sequential bacillus Calmette-Guerin ( BCG ) and electromotive mitomycin ( sequential therapy ) have been shown in a randomized prospective trial to be superior to therapy with BCG alone in patients with high-risk non-muscle-invasive bladder cancer .


The objective of the current study was to compare the costs and benefits of these @ treatment strategies by performing a @-year and @-year cost-effectiveness study .


A Markov model was developed to estimate the incremental cost-effectiveness ratio over a @-year and @-year period .


Estimates of disease progression , death , and treatment efficacy were obtained from what to the authors ' knowledge is the only randomized trial comparing the @ therapies .


Costs included : @ ) medical costs ( physician fees ) ; @ ) drug costs ( preparation and instillation ) ; and @ ) hospital costs ( procedure fees , admission fees , and tests and procedures done during surveillance ) .


Patients were allowed a second course of induction therapy .


Sequential therapy was found to be associated with a higher initial material cost for induction and maintenance .


The average effectiveness for the patients treated with therapy with BCG alone was @ years with a mean cost of $ @ ( @ % confidence interval , $ @ - $ @ ) per patient .


The sequential group resulted in an average effectiveness of @ years , with a mean cost of $ @,@ ( @ % confidence interval , $ @,@ - $ @,@ ) .


The @-year incremental cost-effectiveness ratio of sequential versus BCG-alone therapy was $ @,@ per life-year gained .


The corresponding figure over a @-year period was $ @ per life-year gained .


The results of the current study suggest that sequential therapy is a cost-effective treatment for patients with high-risk non-muscle-invasive bladder cancer .


Cross-match-compatible platelets are used to support thrombocytopenic patients who are refractory to randomly selected platelets .


However , few studies have addressed the efficacy of using this strategy for patients requiring intensive platelet transfusion therapy .


The aim of this study was to determine the effectiveness of cross-match-compatible platelets in an unselected group of patients refractory to platelets from random donors .


A total of @ cross-match-compatible platelet components were administered to @ evaluable patients who were refractory to random-donor platelets .


A solid-phase red cell adherence method was used for platelet cross-matching .


The corrected count increment was used to monitor the effectiveness of each platelet transfusion .


Multivariate analysis was performed to detect whether any variables could predict the response to transfusion .


Statistically significant improvements were found in the mean corrected count increment when comparing cross-match-compatible platelets with randomly selected and incompatible platelets ( p < @ for each ) .


Compatible platelet transfusions were associated with a good response in @ % of cases while incompatible platelets were associated with a poor response in @ % of transfusion events ( p < @ ) .


In the presence of clinical factors or alloimmunisation , compatible platelets were associated with good responses in @ % and @ % respectively vs @ % and @ % in their absence ( p = @ , p < @ ) .


Multivariate analysis revealed that cross-matching and alloimmunisation were the strongest predictors of transfusion response at @ hour , while ABO compatibility , type of units received , followed by alloimmunisation then clinical factors were predictors at @ hours .


Platelet cross-matching using the solid-phase red cell adherence technique is an effective and rapid first-line approach for the management of patients refractory to platelet transfusions .


To evaluate the effect of scapular stabilization during horizontal adduction stretching ( cross-body ) on posterior shoulder tightness ( PST ) and passive internal rotation ( IR ) .


Randomized controlled trial with single blinding .


Athletic club .


Asymptomatic volleyball players who are women with glenohumeral internal rotation deficit ( N = @ ) .


Subjects were randomly assigned to either horizontal adduction stretching with manual scapular stabilization ( n = @ ) or horizontal adduction stretching without stabilization ( n = @ ) .


Passive stretching was performed for @ - to @-second holds in both groups .


Range of motion measurements of PST and IR were performed on the athlete 's dominant shoulder prior to and immediately after the intervention .


Baseline mean angular measurements of PST and IR for all athletes involved in the study were @ and @ , respectively , with no significant difference between groups ( P = @ and P = @ , respectively ) .


Mean PST measurements were significantly different between groups after the horizontal adduction stretch , with a mean angle of @ among the scapular stabilization group and @ among the nonstabilization group ( P < @ ) .


Measurements of IR were also significantly different between groups , with a mean angle of @ among the scapular stabilization group and @ among the nonstabilization group ( P = @ ) .


Horizontal adduction stretches performed with scapular stabilization produced significantly greater improvements in IR and PST than horizontal adduction stretching without scapular stabilization .


Early goal-directed therapy ( EGDT ) has been endorsed in the guidelines of the Surviving Sepsis Campaign as a key strategy to decrease mortality among patients presenting to the emergency department with septic shock .


However , its effectiveness is uncertain .


In this trial conducted at @ centers ( mostly in Australia or New Zealand ) , we randomly assigned patients presenting to the emergency department with early septic shock to receive either EGDT or usual care .


The primary outcome was all-cause mortality within @ days after randomization .


Of the @ enrolled patients , @ were assigned to the EGDT group and @ to the usual-care group .


Primary outcome data were available for more than @ % of the patients .


Patients in the EGDT group received a larger mean ( SD ) volume of intravenous fluids in the first @ hours after randomization than did those in the usual-care group ( @ ml vs. @ ml ) and were more likely to receive vasopressor infusions ( @ % vs. @ % ) , red-cell transfusions ( @ % vs. @ % ) , and dobutamine ( @ % vs. @ % ) ( P < @ for all comparisons ) .


At @ days after randomization , @ deaths had occurred in the EGDT group and @ had occurred in the usual-care group , for rates of death of @ % and @ % , respectively ( absolute risk difference with EGDT vs. usual care , -@ percentage points ; @ % confidence interval , -@ to @ ; P = @ ) .


There was no significant difference in survival time , in-hospital mortality , duration of organ support , or length of hospital stay .


In critically ill patients presenting to the emergency department with early septic shock , EGDT did not reduce all-cause mortality at @ days .


( Funded by the National Health and Medical Research Council of Australia and the Alfred Foundation ; ARISE ClinicalTrials.gov number , NCT@ . )


The purpose of this study was to investigate the incidence of cyclops lesions and its relationship with the cross-sectional area of the intercondylar notch .


For this study , @ patients ( @ male and @ female ) underwent follow-up arthroscopy after bi-socket anterior cruciate ligament reconstruction with hamstring tendon grafts were included .


All patients underwent magnetic resonance imaging measurements of intercondylar notch dimensions .


We compared the femoral intercondylar notch sizes and bone tunnel sizes between knees with cyclops lesions ( cyclops group ) and those without cyclops lesions ( no-cyclops group ) .


The mean percentage of the tunnel size to the cross-sectional area of the femoral intercondylar notch was also compared between the groups .


The median follow-up duration was @ years .


Cyclops lesions were found in @ of the @ knees ( @ % ) on second-look arthroscopy ( cyclops group ) .


Only @ of the @ knees ( @ % ) had extension loss ( cyclops syndrome ) .


The cyclops group included @ men and @ women .


The two groups showed a statistical difference in sex variation ( P = @ ) .


No significant differences were found in the femoral and tibial tunnel sizes between the two groups .


The cross-sectional area of the femoral intercondylar notch was significantly smaller in the cyclops group ( @ mm ( @ ) ) than in the no-cyclops group ( @ mm ( @ ) ) ( P < @ ) .


The percentage of the total femoral tunnel size to the cross-sectional area of the femoral intercondylar notch was significantly higher in the cyclops group ( @ % ) than in the no-cyclops group ( @ % ) ( P = @ ) .


A smaller intercondylar notch size may be a potential risk factor for cyclops lesion formation .


Case-control study , Level IV .


Pancreatic islet transplantation stabilises glycaemic control in type @ diabetes mellitus patients with neuroglycopoenia , despite them not achieving insulin independence because of limited graft function .


However , the extent and underlying metabolic pathways of restored glucose counterregulation are unknown .


We therefore compared systemic glucose turnover , including lactate gluconeogenesis ( GN ) and muscle glucose uptake , in individuals with type @ diabetes who were transplant recipients with partial graft function ( T@DM/ITx ( + ) ) , matched non-transplanted individuals with type @ diabetes ( T@DM/ITx ( - ) ) and matched healthy non-diabetic individuals .


Participants ( n = @ in each group ) underwent a euglycaemic and a hypoglycaemic ( @-@ @ mmol/l ) hyperinsulinaemic clamp ( @ mU kg ( -@ ) min ( -@ ) ) in a randomised crossover fashion .


Systemic and skeletal muscle glucose and lactate kinetics were assessed using a combination of isotopic and forearm balance techniques .


Whole-body glucose counterregulation , the difference in glucose infusion rates required to maintain the glycaemic goal between the hypoglycaemic and euglycaemic clamps , was improved in T@DM/ITx ( + ) ( @ mol kg ( -@ ) min ( -@ ) ) compared with T@DM/ITx ( - ) ( @ mol kg ( -@ ) min ( -@ ) ) , but was ~ @ % lower than in controls ( @ mol kg ( -@ ) min ( -@ ) ) .


Increased endogenous glucose production ( EGP ) and decreased systemic glucose disposal accounted for @ % and @ % of glucose counterregulation in T@DM/ITx ( + ) , respectively , compared with @ % and @ % in controls .


Lactate GN increased in T@DM/ITx ( + ) ( @ mol kg ( -@ ) min ( -@ ) ) and controls ( @ mol kg ( -@ ) min ( -@ ) ) , such that it accounted for @ % and @ % of the increased EGP , respectively .


Skeletal muscle accounted for similar proportions of the decrease in systemic glucose disposal in controls ( @ % ) and T@DM/ITx ( + ) ( @ % ) .


Partial islet graft function improves hypoglycaemia counterregulation by increasing EGP , largely via lactate GN and decreasing systemic glucose disposal .


This may explain the reduction in severe hypoglycaemic events in T@DM/ITx ( + ) individuals .


Advancing age is linked to a decrease in beneficial bacteria such as Bifidobacterium spp .


and reduced aspects of innate immune function .


We investigated whether daily consumption of a probiotic -LSB- Bacillus coagulans GBI-@ , @ ( BC@ ) ; GanedenBC ( @ ) -RSB- could improve immune function and gut function in men and women aged @-@ y , using a double-blind , placebo-controlled crossover design .


Thirty-six volunteers were recruited and randomly assigned to receive either a placebo ( microcrystalline cellulose ) or the probiotic BC@ ( @ @ ( @ ) colony-forming units/capsule ) .


Volunteers consumed @ treatment capsule per day for @ d , followed by a @-d washout period before switching to the other treatment .


Blood and fecal samples were collected at the beginning and end of each treatment period .


Fecal samples were used to enumerate bacterial groups and concentrations of calprotectin .


Peripheral blood mononuclear cells ( PBMCs ) were extracted from whole blood to assess natural killer cell activity and lipopolysaccharide ( LPS ) - stimulated cytokine production .


C-reactive protein concentrations were measured in plasma .


Consumption of BC@ significantly increased populations of Faecalibacterium prausnitzii by @ log@ cells/mL more than during consumption of the placebo ( P = @ ) , whereas populations of Bacillus spp .


increased significantly by @ log@ cells/mL from baseline in volunteers who consumed BC@ ( P = @ ) .


LPS-stimulated PBMCs showed a @ ng/mL increase in the anti-inflammatory cytokine IL-@ @ d after consumption of BC@ ( P < @ ) , whereas the placebo did not affect IL-@ , and no overall difference was found in the effect of the treatments .


Daily consumption of BC@ by adults aged @-@ y can increase beneficial groups of bacteria in the human gut and potentially increase production of anti-inflammatory cytokines .


This study shows the potential benefits of a probiotic to improve dysbiosis via modulation of the microbiota in older persons .


We compare the frequency of airway and respiratory adverse events leading to an intervention between propofol with @:@ and @:@ mixtures of propofol and ketamine ( ketofol ) .


We performed a randomized , double-blinded trial in which emergency department adults undergoing deep sedation received propofol , @:@ propofol and ketamine , or @:@ propofol and ketamine .


Our primary outcome was the frequency of airway and respiratory adverse events leading to an intervention .


Other outcomes included sedation depth , efficacy , procedure and recovery time , patient satisfaction , pain , and procedural recall .


Two hundred seventy-one subjects completed the trial , @ receiving propofol , @ receiving @:@ propofol and ketamine , and @ receiving @:@ propofol and ketamine .


Airway or respiratory adverse events leading to an intervention were similar between groups : @ % , @ % , and @ % , respectively ( P = @ ) .


There were no serious adverse events in any group .


Secondary outcomes were generally similar between groups , with greater recovery agitation observed in the @:@ ketofol group ( @ % , @ % , and @ % , respectively ) .


We found a similar frequency of airway and respiratory adverse events leading to intervention between propofol alone and either @:@ or @:@ ketofol .


To examine the effectiveness of a standardised Urinary Continence Physiotherapy Programme for older Chinese women with stress , urge , or mixed urinary incontinence .


A controlled trial .


Six elderly community health centres in Hong Kong .


A total of @ women aged over @ years with mild-to-moderate urinary incontinence .


Participants were randomly assigned to the intervention group ( n = @ ) where they received eight sessions of Urinary Continence Physiotherapy Programme for @ weeks .


This group received education about urinary incontinence , pelvic floor muscle training with manual palpation and verbal feedback , and behavioural therapy .


The control group ( n = @ ) was given advice and an educational pamphlet on urinary incontinence .


There was significant improvement in urinary symptoms in the intervention group , especially in the first @ weeks .


Compared with the control group , participants receiving the intervention showed significant reduction in urinary incontinence episodes per week with a mean difference of -@ ( @ % confidence interval , -@ to -@ ; t = -@ ; P < @ ) and significant improvement of quality of life with a mean difference of -@ ( @ % confidence interval , -@ to -@ ; t = -@ ; P < @ ) measured by Incontinence Impact Questionnaire Short Form modified Chinese ( Taiwan ) version .


The subjective perception of improvement , measured by an @-point visual analogue scale , was markedly better in the intervention group ( mean , @ ; standard deviation , @ ; @ % confidence interval , @-@ @ ) than in the control group ( mean , @ ; standard deviation , @ ; @ % confidence interval , @-@ @ ; t = @ ; P < @ ) .


The mean treatment satisfaction in the intervention group was @ ( standard deviation , @ ) as measured by an @-point visual analogue scale .


This study demonstrated that the Urinary Continence Physiotherapy Programme was effective in alleviating urinary symptoms among older Chinese women with mild-to-moderate heterogeneous urinary incontinence .


To determine if motivational interviewing ( MI ) improves self-efficacy ( primary outcome ) , depressive symptoms ( secondary outcome ) , and stage-of-readiness-to-change ( secondary outcome ) among women in abusive relationships .


Randomized controlled trial among women who experienced intimate partner violence in a current relationship over the past @ months .


Subjects were recruited from two family planning clinics ( December @ to May @ ) .


The intervention included an initial face-to-face session and three telephone sessions administered @ - , @ - , and @-months postenrollment , each using MI to identify personal goals .


Controls were referred to community-based resources .


Outcomes were measured by self-administered questionnaires before randomization and @ months later .


Modified intent-to-treat analyses of completed participants were conducted using multivariate analysis of variance for continuous outcomes and polytomous logistic regression for categorical outcomes .


Three hundred six eligible women were enrolled ( recruitment rate = @ % ) ; @ completed the @-month follow-up ( completion rate = @ % ) .


Depressive symptoms decreased to a greater extent in MI than referral women ( P = @ ) .


Self-efficacy and stage-of-readiness-to-change increased more in MI than referral women , but these differences were not statistically significant .


With a lower than projected sample size , our findings did not achieve statistical significance at the @ % level but suggest a beneficial effect of the MI intervention on reducing depressive symptoms .


To evaluate the effectiveness of total laparoscopic hysterectomy compared with laparoscopic supracervical hysterectomy for alleviating dysmenorrhoea .


Randomised blinded controlled trial .


Norwegian university teaching hospital .


Sixty-two women with dysmenorrhoea .


Participants randomised to either total laparoscopic hysterectomy ( n = @ ) or laparoscopic supracervical hysterectomy ( n = @ ) .


The primary outcome measure , measured @ months after intervention , was reduction of cyclic pelvic pain ( visual analogue scale , @-@ ) .


Secondary outcome measures included patient satisfaction ( visual analogue scale , @-@ ) and quality of life ( Short Form @ , @-@ ) .


The groups were comparable at baseline .


There was no difference in self-reported dysmenorrhoea at @ months ( mean @ -LSB- SD @ -RSB- versus @ -LSB- SD @ -RSB- , P = @ ) .


There was no difference in patient satisfaction ( mean @ -LSB- SD @ -RSB- versus @ -LSB- SD @ -RSB- , P = @ ) or quality of life ( mean @ -LSB- SD @ -RSB- versus @ -LSB- SD @ -RSB- , P = @ ) .


Improvement in dysmenorrhoea and quality of life as well as patient satisfaction were comparable in the medium term when comparing total laparoscopic hysterectomy with laparoscopic supracervical hysterectomy .


For many individuals , daily commuting activities on roadways account for a substantial proportion of total exposure , as well as peak-level exposures , to traffic-related air pollutants ( TRAPS ) including ultrafine particles , but the health impacts of these exposures are not well-understood .


We sought to determine if exposure to TRAPs particles during commuting causes acute oxidative stress in the respiratory tract or changes in heart rate variability ( HRV ) , a measure of autonomic activity .


We conducted a randomized , cross-over trial in which twenty-one young adults took two @-hr rides in a passenger vehicle in morning rush-hour traffic .


The subjects wore a powered-air-purifying respirator , and were blinded to high-efficiency particulate air ( HEPA ) filtration during one of the rides .


At time points before and after the rides , we measured HRV and markers of oxidative stress in exhaled breath condensate ( EBC ) including nitrite , the sum of nitrite and nitrate , malondialdehyde , and @-isoprostane .


We used mixed linear models to evaluate the effect of exposure on EBC and HRV outcomes , adjusting for pre-exposure response levels .


We used linear models to examine the effects of particle concentrations on EBC outcomes at post-exposure time points .


Mean EBC nitrite and the sum of nitrite and nitrate were increased from baseline at immediately post-exposure comparing unfiltered to filtered rides ( @ M vs @ M , p = @ and @ M vs @ M , p = @ , respectively ) .


Mean EBC malondialdehyde ( MDA ) concentrations were about @ % greater following the unfiltered vs. filtered exposures , although this result was not statistically significant .


We found no significant associations between exposure to traffic particles and HRV outcomes at any of the time points .


At immediately post-exposure , an interquartile range increase in particle number concentration was associated with statistically significant increases in nitrite ( @ % , @ % CI @ % to @ % ) and nitrite + nitrate ( @ % , @ % CI @ % to @ % ) .


Increases in markers of oxidative stress in EBC may represent early biological responses to widespread exposures to TRAPs particles that affect passengers in vehicles on heavily trafficked roadways .


Off-pump coronary artery bypass grafting ( OPCAB ) is a popular treatment for patients with ischemic heart disease , especially for high-risk patients .


However , whether OPCAB can lead to better clinical outcomes than on-pump coronary artery bypass grafting ( ONCAB ) in patients with enlarged ventricles remains controversial .


This prospective randomized study was designed to characterize comparison of early clinical outcome and mid-term follow-up following ONCAB versus OPCAB in patients with triple-vessel disease and enlarged ventricles .


Prospective randomized trial of patients treated at The First Affiliated Hospital , China Medical University , over a @-year period ( @-@ ) .


A total of @ patients with triple-vessel disease and enlarged ventricles ( end-diastolic dimension > = @ cm ) were randomized to OPCAB or ONCAB between July @ and December @ .


The in-hospital out.comes were analyzed .


The study included a mid-term follow-up , with a mean follow-up time of @ ( @ months ) .


No significant differences were recorded in the baseline clinical characteristics of ONCAB and OPCAB groups .


A statistical difference was found between the two groups at the time of extubation , intensive care unit stay , hospital stay , blood requirements , incidence of intra-aortic balloon pump support , pulmonary complications , stroke , reoperation for bleeding , and inotropic requirements > @ hours ( P < @ ) .


The number of anastomoses performed per patient , the incidence of postoperative ventricular arrhythmia , myocardial infarction , new-onset atrial fibrillation , hemodialysis , infective complications , recurrent angina , and percutaneous reintervention were similar between the @ groups ( P > @ ) .


The left ventricular end-diastolic dimension was significantly smaller at @ months ' follow-up in the @ groups than it was before operation ( < @ ) .


No differences in hospital mortality and mid-term mortality between OPCAB and ONCAB groups were found .


During the follow-up , no patient in either group had undergone repeat coronary artery bypass grafting .


No differences in early and mid-term mortality were found between OPCAB and ONCAB in patients with triple-vessel disease and enlarged ventricles .


However , OPCAB seems to have a beneficial effect on postoperative complications .


The aim of this study was to compare the esthetic judgments of orthodontists and laypeople regarding the appearance of palatally displaced canines @ months after treatment with either a closed or an open surgical exposure and orthodontic alignment .


A multicenter randomized controlled trial was undertaken in @ hospitals in the United Kingdom .


Patients with unilateral palatally displaced canines were randomly allocated to receive either a closed or an open surgical exposure .


The teeth were aligned with fixed appliances , and @ months after debond , intraoral photographs were taken .


The photographs were projected in random order to @ panels of judges ( orthodontists and laypeople ) , who completed a questionnaire .


The images of @ participants ( closed , @ ; open , @ ) were included .


The laypeople were able to identify the operated tooth only @ % of the time ( @ % CI , @ % -@ % ) ; this was no better than chance ( P = @ ) .


The orthodontists were more successful but still identified the treated canine with certainty only @ % of the time ( @ % CI , @ % -@ % ; P = @ ) .


Both panels more frequently assessed the unoperated canine to have a better appearance than the contralateral operated canine ; however , there were no differences between the closed and open groups ( proportion preferring unoperated canine-laypeople : closed , @ % ; open , @ % ; P = @ ; and orthodontists : closed , @ % ; open , @ % ; P = @ ) .


There is an esthetic impact to aligning a palatally displaced canine , but it is mostly minor and unlikely to be detectable by laypeople .


The esthetic impact was the same , whether the canine was exposed with a closed or an open surgical technique .


Rumination is one of the hallmark characteristics of both anxiety disorders and depression , and has been linked to deficient executive functioning , particularly working memory ( WM ) .


Previous findings show that working memory capacity can be increased through training .


The current study explored whether an adaptive stand-alone WM training could increase WMC and consequently reduce rumination , anxiety and depression by means of a double-blind randomized controlled trial in a sample of @ patients with symptoms of anxiety and/or depression .


No positive effect of training on WMC was found .


In addition , the results show that a WM training was not associated with a reduction of rumination , depression , nor anxiety .


The high drop-out rate in both groups ( @ % from pre - to post-training ) and the overrepresentation of men and use of anti-depressants in the placebo group might have influenced the results .


Furthermore , expectations and perceptions about the training might have interacted with performance on WM tasks .


Overall , results show that a stand-alone WM training in patients with symptoms of anxiety and/or depression does not result in reduced rumination nor in reduced symptoms of depression and anxiety .


We discuss potential explanations for these findings .


To evaluate the safety ( primary objective ) and efficacy ( secondary objective ) of ( - ) - OSU@ in Huntington 's disease ( HD ) .


In a double-blind , cross-over trial , patients with HD were randomly assigned to start treatment on either ( - ) - OSU@ or placebo .


After @ weeks , those patients who initially received active drug were switched to placebo for another @ weeks , and vice versa .


During the first week the ( - ) - OSU@ dose was @ mg twice daily , during the second week @ mg twice daily , and during the last @ weeks @ mg twice daily .


Motor , cognitive , mental and social functions were rated by the clinical investigator or by self-assessment , using established rating scales .


Fifteen patients fulfilling inclusion and exclusion criteria completed the study .


( - ) - OSU@ was well tolerated by all patients and no adverse effects were observed .


( - ) - OSU@ treatment significantly improved the Short Form @ Vitality score , mainly due to an improvement of the individual item ` worn-out ' ( VT@ ) .


In addition , an improvement of depressive symptoms was found using Beck Depression Inventory .


In contrast to a general trend of improvement in several non-motor variables only small and non-significant differences between ( - ) - OSU@ and placebo were found regarding motor functions .


( - ) - OSU@ offers promise for the treatment of HD , as a drug with good tolerability , capable of improving the patients ' experienced non-motor functions such as energy and mood and thus alleviating symptoms of great importance for their quality of life .


Neurofilaments ( Nf ) are major structural proteins that occur exclusively in neurons .


In spinal cord injury ( SCI ) , the severity of disease is quantified by clinical measures that have limited sensitivity and reliability , and no blood-based biomarker has been established to further stratify the degree of injury .


We aimed to examine a serum-based NfL immunoassay as predictor of the clinical outcome in SCI .


Longitudinal measurement of serum NfL was performed in patients with central cord syndrome ( CCS , n = @ ) , motor-incomplete SCI ( iSCI , n = @ ) , motor-complete SCI ( cSCI , n = @ ) and healthy controls ( HC , n = @ ) , and correlated with clinical severity , neurological outcome , and neuroprotective effect of the drug minocycline .


Baseline NfL levels were higher in iSCI ( @pg/mL ) and cSCI ( @pg/mL ) than in HC ( @pg/mL , p = @ and p < @ ) and CCS ( @pg/mL , p = @ and p = @ ) .


Levels increased over time ( p < @ ) and remained higher in cSCI versus iSCI ( p = @ ) and than in CCS ( p < @ ) .


NfL levels correlated with American Spinal Injury Association ( ASIA ) motor score at baseline ( r = -@ , p = @ ) and after @h ( r = -@ , p < @ ) and @-@-month motor outcome ( baseline NfL : r = -@ , p = @ and @h NfL : r = -@ , p < @ ) .


Minocycline treatment showed decreased NfL levels in the subgroup of cSCI patients .


Serum NfL concentrations in SCI patients show a close correlation with acute severity and neurological outcome .


Our data provide evidence that serum NfL is of prognostic value in SCI patients for the first time .


Further , blood NfL levels may qualify as drug response markers in SCI .


The aim of this study was to evaluate the effectiveness of unstable shoes in reducing low back pain in health professionals .


Of a volunteer sample of @ participants , @ with nonspecific chronic low back pain were eligible and enrolled in this study .


Participants were randomized to an intervention group , who wore unstable shoes ( model MBT Fora ) , or a control group , who wore conventional sports shoes ( model Adidas Bigroar ) .


The participants had to wear the study shoes during their work hours , and at least @ hours per workday , over a period of @ weeks .


The primary outcome was low back pain assessed on a Visual Analog Scale .


The secondary outcomes were patient satisfaction , disability evaluated using Roland-Morris questionnaire and quality of life evaluated using EQ-VAS .


The intervention group showed a significant decrease in pain scores compared to the control group .


The rate of satisfaction was higher in the intervention group ( @ % ) compared to the control group ( @ % ) .


There was no significant difference for the Roland-Morris disability questionnaire score and the EQ-VAS scale .


The results of this clinical trial suggest that wearing unstable shoes for @ weeks significantly decreases low back pain in patients suffering from chronic low back pain but had no significant effect on quality of life and disability scores .


We previously reported that compared to standard glycemic control -LSB- blood glucose ( BG ) : @-@ mg/dL -RSB- , patients randomized to intensive glycemic control ( BG : @-@ mg/dL ) were at increased risk of graft rejection in renal transplantation .


However , the underlying mechanisms that associate the effect of intensive glycemic control with renal transplant outcomes have not been identified .


A secondary data analysis of @ participants ( n = @ intensive , n = @ control ) was conducted using data from a previous randomized controlled clinical trial .


We examined inflammatory biomarkers , glycemic variability , hypoglycemia , and hyperglycemia as potential contributing etiologies by assessing the effect of intensive glycemic control on these characteristics , and evaluate the association of these variables with graft rejection .


Intensive glycemic control had no appreciable effect on highly sensitive C-reactive protein , interleukin ( IL ) -@ , tumor necrosis factor alpha , IL-@ , or IL-@ levels at all time points after transplantation .


Moreover , neither inflammatory biomarkers nor increased glycemic variability were associated with graft rejection .


However , intensive treatment increased the risk of hypoglycemia ( BG < @ mg/dL , @ % vs. @ % , P < @ ) .


In sub-analysis , compared to non-rejecters , rejecters demonstrated higher rates of blood glucose below @ mg/dL ( @ % vs. @ % , P = @ ) .


Inflammatory biomarkers and increased glycemic variability lack correlation with clinical outcomes in renal transplant , but importantly , increased perioperative hypoglycemic episodes ( BG < @mg/dL ) may be a salient etiology that contributed to the increased risk for acute allograft rejection related to intensive glycemic control .


Further research is needed to confirm a causal association .


To investigate the influence of glycosylated hemoglobin ( HbA@c ) on treatment outcomes in patients with diabetic macular edema ( DME ) receiving intravitreal ranibizumab .


Post hoc analysis of @ identical phase III clinical trials assessing the efficacy and safety of intravitreal ranibizumab in DME over @ months ( RIDE : NCT@/RISE : NCT@ ) .


A total of @ adults with vision loss from DME treated with ranibizumab were included in this analysis from RIDE/RISE .


Participants received monthly intravitreal ranibizumab ( @ or @ mg ) .


Differences in visual and anatomic outcomes , and diabetic retinopathy ( DR ) severity score , between subgroups of patients with baseline HbA@c @ % versus HbA@c > @ % at @ months .


There were @ patients in RIDE/RISE who were treated with ranibizumab with a baseline HbA@c @ % and @ patients with a baseline HbA@c > @ % included in this analysis .


The mean improvement in visual acuity ( VA ) at @ months was +@ Early Treatment Diabetic Retinopathy Study ( ETDRS ) letters in patients with baseline HbA@c @ % compared with +@ ETDRS letters in the patients with a baseline HbA@c > @ % ( P = @ ) .


After adjustment for baseline central foveal thickness ( CFT ) and duration of diabetes , the mean CFT reduction was -@ m in patients with a baseline HbA@c @ % and -@ m in patients with a baseline HbA@c > @ % ( P = @ ; @ % confidence interval , -@ to @ ) .


The proportion of patients with a @-step improvement in DR severity score was @ % in patients with baseline HbA@c @ % compared with @ % in the patients with a baseline HbA@c > @ % ( P = @ ) .


There was no correlation of baseline HbA@c with any visual or anatomic parameter .


The improvement in VA , anatomic reduction of macular edema , and improvement in DR severity score with ranibizumab treatment seem to be independent of baseline HbA@c .


To determine whether testosterone therapy improves glucose metabolism in men with type @ diabetes ( T@D ) and lowered testosterone .


We conducted a randomized , double-blind , parallel , placebo-controlled trial in @ men with T@D , aged @-@ years with an HbA@c @ % ( @ mmol/mol ) , and a total testosterone level , measured by immunoassay , of @ nmol/L ( @ ng/dL ) .


Participants were randomly assigned to @ weeks of intramuscular testosterone undecanoate ( n = @ ) or matching placebo ( n = @ ) .


All study subjects were included in the primary analysis .


Seven men assigned to testosterone and six men receiving placebo did not complete the study .


Main outcome measures were insulin resistance by homeostatic model assessment ( HOMA-IR , primary outcome ) and glycemic control by HbA@c ( secondary outcome ) .


Testosterone therapy did not improve insulin resistance ( mean adjusted difference -LSB- MAD -RSB- for HOMA-IR compared with placebo -@ -LSB- @ % CI -@ to @ ; P = @ -RSB- ) or glycemic control ( MAD HbA@c @ % -LSB- @-@ @ -RSB- ; P = @ ) , despite a decrease in fat mass ( MAD -@ kg -LSB- -@ to -@ -RSB- ; P < @ ) and an increase in lean mass ( MAD @ kg -LSB- @-@ @ -RSB- ; P < @ ) .


Testosterone therapy reduced subcutaneous ( MAD -@ cm ( @ ) -LSB- -@ to -@ -RSB- ; P < @ ) but not visceral abdominal adipose tissue ( MAD @ cm ( @ ) -LSB- -@ to @ -RSB- ; P = @ ) .


Testosterone therapy does not improve glucose metabolism or visceral adiposity in obese men with moderately controlled T@D and modest reductions in circulating testosterone levels typical for men with T@D .


To test the feasibility , acceptability and safety of a pediatric advance care planning intervention , Family-Centered Advance Care Planning for Teens With Cancer ( FACE-TC ) .


Adolescent ( age @-@ years ) / family dyads ( N = @ ) with a cancer diagnosis participated in a two-armed , randomized , controlled trial .


Exclusion criteria included severe depression and impaired mental status .


Acceptability was measured by the Satisfaction Questionnaire .


General Estimating Equations models assessed the impact of FACE-TC on @-month post-intervention outcomes as measured by the Pediatric Quality of Life Inventory @ Generic Core Scale , the Pediatric Quality of Life Inventory @ Cancer-Specific Module , the Beck Depression and Anxiety Inventories , the Spiritual Well-Being Scale of the Functional Assessment of Chronic Illness Therapy-IV , and advance directive completion .


Acceptability was demonstrated with enrollment of @ % of eligible families , @ % attendance at all three sessions , @ % retention at @-month post-intervention , and @ % data completion .


Intervention families rated FACE-TC worthwhile ( @ % ) , whereas adolescents ' ratings increased over time ( @ % -@ % ) .


Adolescents ' anxiety decreased significantly from baseline to @ months post-intervention in both groups ( = -@ ; p = @ ) .


Low depressive symptom scores and high quality of life scores were maintained by adolescents in both groups .


Advance directives were located easily in medical records ( @ % of FACE-TC adolescents vs. no controls ) .


Oncologists received electronic copies .


Total Spirituality scores ( = @ ; p = @ ) were significantly higher among FACE-TC adolescents versus controls .


The FACE-TC adolescents endorsed the best time to bring up end-of-life decisions : @ % before being sick , @ % at diagnosis , none when first ill or hospitalized , @ % when dying , and @ % for all of the above .


Family-Centered Advance Care Planning for Teens With Cancer demonstrated feasibility and acceptability .


Courageous adolescents willingly participated in highly structured , in-depth pediatric advance care planning conversations safely .


We report the results of long-term follow-up of the Pacing to Avoid Cardiac Enlargement ( PACE ) trial , a prospective , double-blinded , randomized , multicentre study that confirmed the superiority of biventricular ( BiV ) pacing compared with right ventricular apical ( RVA ) pacing in prevention of LV adverse remodelling and deterioration of systolic function at @ and @ years .


Patients with bradycardia and preserved LVEF were randomized to receive RVA ( n = @ ) or BiV pacing ( n = @ ) .


Co-primary endpoints were LV end-systolic volume ( LVESV ) and LVEF measured by echocardiography .


There were @ patients who had extended follow-up , with a mean duration of @ @ years ( @-@ @ years ) .


The primary endpoint analyses were performed in @ patients ( @ in the RVA group and @ in the BiV group ) .


In the RVA pacing group , the LVEF decreased while the LVESV increased progressively at follow-up , but remained unchanged in the BiV pacing group .


The differences in LVEF between the RVA and BiV groups were -@ , -@ , and -@ % at @-year , @-year , and long-term follow-up , respectively ( all P < @ ) .


The corresponding differences in LVESV were +@ , +@ , and +@ mL , respectively ( all P < @ ) .


The deleterious effects of RVA pacing consistently occurred in all the pre-defined subgroups .


Furthermore , patients with RVA pacing had a significantly higher prevalence of heart failure hospitalization than the BiV group ( @ % vs. @ % , log-rank = @ , P = @ ) .


Left ventricular adverse remodelling and deterioration of systolic function continued at long-term follow-up in patients with RVA pacing ; this deterioration was prevented by the use of BiV pacing .


Also , heart failure hospitalization was more prevalent in the RVA pacing group .


No highly effective interventions to prevent delirium have been identified .


To examine whether ramelteon , a melatonin agonist , is effective for the prevention of delirium .


A multicenter , rater-blinded , randomized placebo-controlled trial was performed in intensive care units and regular acute wards of @ university hospitals and @ general hospital .


Eligible patients were @ to @ years old , newly admitted due to serious medical problems , and able to take medicine orally .


Patients were excluded from the study if they had an expected stay or life expectancy of less than @ hours .


Sixty-seven patients were randomly assigned using the sealed envelope method to receive ramelteon ( @ mg/d ; @ patients ) or placebo ( @ patients ) every night for @ days .


Incidence of delirium , as defined by the Diagnostic and Statistical Manual of Mental Disorders ( Fourth Edition ) .


Ramelteon was associated with a lower risk of delirium ( @ % vs @ % ; P = @ ) , with a relative risk of @ ( @ % CI , @-@ @ ) .


Even after risk factors were controlled for , ramelteon was still associated with a lower incidence of delirium ( P = @ ; odds ratio , @ -LSB- @ % CI , @-@ @ -RSB- ) .


The Kaplan-Meier estimates of time to development of delirium were @ ( @ % CI , @-@ @ ) days for ramelteon and @ ( @-@ @ ) days for placebo .


Comparison by log-rank test showed that the frequency of delirium was significantly lower in patients taking ramelteon than in those taking placebo ( ( @ ) = @ ; P = @ ) .


Ramelteon administered nightly to elderly patients admitted for acute care may provide protection against delirium .


This finding supports a possible pathogenic role of melatonin neurotransmission in delirium .


Consumption of energy drinks is increasing amongst athletes and the general public .


By virtue of their bioactive ingredients ( including caffeine , taurine , glucuronolactone , and B-group vitamins ) and paucity of calories , sugar-free `` diet '' versions of these drinks could be a useful aid for weight maintenance .


Yet little is known about the acute influence of these drinks , and specifically the role of the cocktail of non-caffeine ingredients , on resting energy expenditure ( REE ) and substrate oxidation .


Therefore , the metabolic impact of sugar-free Red Bull ( sfRB ) to a comparable amount of caffeine was compared .


REE and respiratory quotient ( RQ ) were measured in eight healthy young men by ventilated-hood indirect calorimetry for @ min baseline and @ h following ingestion of @ ml of either : sfRB + placebo , water +@ mg caffeine , or water + placebo , according to a randomized cross-over design .


sfRB and water + caffeine both increased REE to the same degree ( +@ % ) .


Additionally , sfRB briefly increased RQ .


Water + caffeine had no effect on RQ relative to water + placebo .


sfRB enhanced thermogenesis and marginally shifted RQ to favor carbohydrate oxidation .


The stimulatory effects of sfRB on REE are mimicked by water + caffeine , indicating that the auxiliary ingredients do not influence this thermic effect .


The metabolic effects of sfRB are primarily due to caffeine alone .


Guidelines recommend saline hydration for prophylaxis of contrast-induced acute kidney injury ( CI-AKI ) in patients with chronic kidney disease ( CKD ) undergoing intravenous contrast media-enhanced CT ( CE-CT ) .


The safety and efficacy of a brief hydration protocol using sodium bicarbonate in this population is unknown .


We analysed whether @-h sodium bicarbonate hydration prior to CE-CT is non-inferior to saline hydration prior to and after CE-CT in CKD patients .


We performed an open-label multicentre randomized trial .


Patients were randomized to @ mL of @ % sodium bicarbonate hydration prior to CE-CT or @ mL of @ % saline hydration prior to and , once again , after CE-CT .


Primary outcome was the relative increase in serum creatinine @-@ h post-CE-CT .


Secondary outcomes were incidence of CI-AKI -LSB- serum creatinine increase > @ % / > @ mol/L ( @ mg/dL ) -RSB- , recovery of renal function , the need for dialysis and @-month hospital costs .


Five hundred and seventy adult CKD patients undergoing CE-CT were randomized between @ and @ , of whom @ were included in the intention-to-treat population .


Mean relative serum creatinine increase was @ % for sodium bicarbonate and @ % for saline ( mean difference -@ % ; @ % confidence interval -@ to @ , P-value for non-inferiority < @ ) .


CI-AKI occurred in @ patients ( @ % ) ; @ ( @ % ) randomized to sodium bicarbonate versus @ ( @ % ) to saline ( P = @ ) .


Renal function recovered in @ and @ % of CI-AKI patients , respectively ( P = @ ) .


No patients developed a need for dialysis .


Mean hydration costs per patient were @ for the sodium bicarbonate and @ for the saline regime ( P < @ ) .


Other healthcare costs were similar .


Short hydration with sodium bicarbonate prior to CE-CT was non-inferior to peri-procedural saline hydration with respect to renal safety and may result in healthcare savings .


-LSB- Netherlands Trial Register ( http://www.trialregister.nl/trialreg/index.asp ) , Nr @ , date of registration @ December @ . -RSB-


Successful recruitment of participants to any trial is central to its success .


Trial results are routinely published , and recruitment is often cited to be slower and more difficult than anticipated .


This article reflects on the methodological challenges of recruiting women with prolapse attending United Kingdom ( UK ) gynaecology outpatient clinics to a multi-centre randomised controlled trial ( RCT ) of physiotherapy , and the systems put in place in an attempt to address them .


Gynaecology outpatients with symptomatic prolapse were to be recruited over a @-month period from @ UK hospitals and one New Zealand hospital .


Eligible women were informed about the trial by their gynaecologist and informed consent was obtained by the central trial office .


Recruitment difficulties were encountered early on , and a number of strategies were employed to try to improve recruitment .


Some strategies were more successful than others and they differed in the resources required .


Actions that facilitated recruitment included increasing recruiting centres to @ UK and two international hospitals , good centre support , using processes embedded in clinical practice , and good communication between the trial office , collaborators and participants .


Collaborator incentives , whereby staff involved received the benefit immediately , were more successful than a nominal monetary payment per woman randomised .


Barriers to recruitment included fewer eligible women than anticipated , patient 's preference to receive active treatment rather than allocation to the control group , lack of support staff and high staff turnover .


Geographical variations in Primary Care Trust Research Management and Governance approval systems and general practitioner ( GP ) referral procedures also impacted negatively on recruitment .


Our article reflects on the methodological challenges of recruiting to a multi-centre RCT in a UK gynaecology setting .


Effective interventions included increasing the number of recruiting centres and providing collaborator incentives .


Barriers to recruitment included fewer eligible women than anticipated , patient 's preference to be allocated to the treatment group , lack of support staff , and variations in approval systems and GP referral procedures .


To improve the evidence base on clinical trial recruitment , trialists need to publish their experiences and lessons learned .


Future RCTs should evaluate , where possible , the effect of strategies designed to improve recruitment and retention .


The hazardous health effects of smoking are established , but there remains a need to evaluate existing smoking prevention strategies and to increase their effectiveness in adolescents .


Strategies focusing on parental attitudes and rule setting have been identified as a potentially effective approach .


The present manuscript describes objectives , study design and methodology of the BEST Prevention study .


BEST Prevention is a three-armed cluster randomized-controlled trial among @th grade ( @-@ years ) students in Berlin , Germany .


Schools were enrolled between @ and @ and allocated using a centralized randomization list into @ ) a student smoking prevention intervention ( visit to an established interactive circuit ) , @ ) the same intervention plus a parent intervention , and @ ) a control group ( visit to an established exercise and nutrition interactive circuit ) .


Students were assessed at baseline , @ and @ months via self-report , as well as via carbon monoxide and cotinine in saliva at the @ month follow-up .


Statistical analyses uses multi-level regression models with cluster effects ( school and class within school ) based on the intention to treat population .


Here we report descriptive baseline characteristics of recruited schools , and schools classes .


Two schools from the control group dropped out after allocation .


Hence , @ secondary schools from all @ districts of the city , including @ school classes and @ students are participating in the study .


Of those , @ students completed the baseline assessment .


The present manuscript provides details on the study design and methodology of a large school-based smoking prevention trial in a metropolitan area in Germany .


Findings from this study will yield important insight into the long-term effectiveness of specific smoking prevention strategies , also in disadvantaged population groups .


Determining efficacy in complementary medicine research requires valid placebo/sham control groups that are credible to patients and ensure successful blinding .


Within the scope of this study , a light touch sham-control intervention for trials of Craniosacral Therapy ( CST ) was developed and tested for its credibility .


Patients of a randomized controlled trial on chronic non-specific neck pain ( NCT@ ) obtained the Credibility/Expectancy Questionnaire and the Helping Alliance/Satisfaction Questionnaire .


Treatment and sham group respectively received @ weekly sessions of CST or light touch .


Data without ( N = @ ) and with multiple imputation ( N = @ ) were analyzed separately using logistic regression models .


Adjusted odds ratios ( AOR ) and @ % confidence intervals ( CI ) were calculated to assess whether group outcome could be predicted from patients ' credibility ratings .


An additional t-test for analysis of the overall compliance/attendance was conducted .


Patients ' ratings of treatment expectancy , credibility and therapeutic alliance were not found to have significant power for classifying patients into CST or sham group ( p. @ ) .


Only satisfaction with treatment revealed a significant impact ( AOR : @ ; @ % CI : -LSB- @ | @ -RSB- ; p = @ ) in the non-imputed analysis , but not in the multiple imputation analysis ( AOR : @ ; @ % CI : -LSB- @ | @ -RSB- ; p = @ ) .


Compliance of both groups was not significantly different ( p > @ ) as were reasons for non-attendance .


No serious adverse events were reported .


Patients ' expectancy , credibility and therapeutic alliance did not appear to affect study outcomes , blinding patients to group allocation was possible , and sham intervention was tolerable and safe .


The design can therefore be recommended as control for non-specific treatment effects in future CST clinical trials .


to explore the clinical effect of LVD on patients with advanced schistosomiasis with chronic B hepatitis and on the course of disease development .


A total of @ patients with advanced schistosomiasis with chronic B hepatitis were enrolled and randomly divided into the treatment group ( @ cases ) and the control group ( @ cases ) .


patients in the treatment group received routinet colligative treatment and LVD @ mg daily , while patients in the control group received routinet colligative treatment only.All the patients were followed up for @ + / - @ months .


The mortality rate was @ % vs. @ % in the treatment and control ( P < @ ) .


The patients whose Child-Pugh score decreased by more than @ were @ % vs. @ % ( P < @ ) .


After treatment the serum ALT TBIL levels dropped , the serum albumin level increased and The improvement of liver function in the treatment group was better than that in the control group ( P < @ ) .


The HBeAg and HBV-DNA negutive rate in the treatment group were higher than those in the control ( P < @ ) .


The HBV-DNA negative rate in thetreatment group was @ % at the end of @ weekes .


The rate of YMDD mutations was @ % , @ % and @ % in the treatment group at the end of @ , @ and @ weeks .


LVD and ADV can inhibit virus replication and the relative stability liver function remained the same in most YMDD mutation patients .


LVD can inhibit virus replication rapidly and improveliver function , prevent exacerbation in patients with advanced schistosomiasis with chronic B hepatitis , LVD and ADV can inhibit virus replication and improve liver function in most YMDD mutation patients .


Multiple sclerosis ( MS ) is a chronic demyelinating disease of the central nervous system .


Riboflavin is involved in myelin formation in nerve cells .


Riboflavin is a precursor of flavin adenine D-nucleotide ( FAD ) , which is a coenzyme of methylene tetrahydrofolate reductase ( MTHFR ) , which is an important enzyme for remethylation of homocysteine .


Riboflavin supplementation has been shown to affect the serum levels of homocysteine in healthy volunteers .


The aim of the present study was to test the effect of riboflavin supplementation on the status and disability of patients with MS and whether this effect could be mediated by serum homocysteine levels .


This was a randomized , double-blind , controlled trial in which @ MS patients with a mean age of @ were tested with riboflavin , and the placebo group , with a mean age of @ , received either riboflavin supplementation ( @ mg ) or the placebo daily for six months .


Disability , measured by the Expanded Disability Status Scale ( EDSS ) scores , erythrocyte glutathione reductase activity coefficient ( EGRAC ) , and serum homocysteine levels were measured before and after the study .


The mean SD of EDSS score was significantly decreased in both groups over the six months of the study ( @ @ vs. @ @ for the riboflavin group and @ @ vs. @ @ for the placebo groups .


The comparison across both groups yielded a non-significant change ( P = @ and @ , respectively ) .


No significant differences were observed between the two groups in terms of EGRAC , riboflavin deficiency levels by EGRAC category , and serum homocysteine levels before and after the study .


Riboflavin supplementation ( @ mg/day ) to patients with MS does not improve disability status .


It appears that this effect is not related to serum homocysteine levels .


The ICON@ trial previously reported improved progression-free survival in women with ovarian cancer with the addition of bevacizumab to standard chemotherapy , with the greatest effect in patients at high risk of disease progression .


We report the final overall survival results of the trial .


ICON@ was an international , phase @ , open-label , randomised trial undertaken at @ centres in @ countries across Europe , Canada , Australia and New Zealand .


Eligible adult women with newly diagnosed ovarian cancer that was either high-risk early-stage disease ( International Federation of Gynecology and Obstetrics -LSB- FIGO -RSB- stage I-IIa , grade @ or clear cell histology ) or more advanced disease ( FIGO stage IIb-IV ) , with an Eastern Cooperative Oncology Group performance status of @-@ , were enrolled and randomly assigned in a @:@ ratio to standard chemotherapy ( six @-weekly cycles of intravenous carboplatin -LSB- AUC @ or @ -RSB- and paclitaxel @ mg/m ( @ ) of body surface area ) or the same chemotherapy regimen plus bevacizumab @ mg per kg bodyweight intravenously every @ weeks , given concurrently and continued with up to @ further @-weekly cycles of maintenance therapy .


Randomisation was done by a minimisation algorithm stratified by FIGO stage , residual disease , interval between surgery and chemotherapy , and Gynecologic Cancer InterGroup group .


The primary endpoint was progression-free survival ; the study was also powered to detect a difference in overall survival .


Analysis was by intention to treat .


This trial is registered as an International Standard Randomised Controlled Trial , number ISRCTN@ .


Between Dec @ , @ , and Feb @ , @ , @ women were enrolled and randomly assigned to receive chemotherapy ( n = @ ) or chemotherapy plus bevacizumab ( n = @ ) .


Median follow-up at the end of the trial on March @ , @ , was @ months ( IQR @-@ ) , at which point @ patients had died ( @ in the chemotherapy group and @ in the bevacizumab group ) .


Our results showed evidence of non-proportional hazards , so we used the difference in restricted mean survival time as the primary estimate of effect .


No overall survival benefit of bevacizumab was recorded ( restricted mean survival time @ months -LSB- @ % CI @-@ -RSB- in the standard chemotherapy group vs @ months -LSB- @-@ -RSB- in the bevacizumab group ; log-rank p = @ ) .


In an exploratory analysis of a predefined subgroup of @ patients with poor prognosis disease , @ ( @ % ) died ( @ in the standard chemotherapy group and @ in the bevacizumab group ) , and a significant difference in overall survival was noted between women who received bevacizumab plus chemotherapy and those who received chemotherapy alone ( restricted mean survival time @ months -LSB- @ % CI @-@ -RSB- with standard chemotherapy vs @ months -LSB- @-@ -RSB- with bevacizumab ; log-rank p = @ ) .


However , in non-high-risk patients , the restricted mean survival time did not differ significantly between the two treatment groups ( @ months -LSB- @ % CI @-@ -RSB- ) in the standard chemotherapy group vs @ months -LSB- @-@ -RSB- in the bevacizumab group ; p = @ ) .


An updated analysis of progression-free survival showed no difference between treatment groups .


During extended follow-up , one further treatment-related grade @ event ( gastrointestinal fistula in a bevacizumab-treated patient ) , three grade @ treatment-related events ( cardiac failure , sarcoidosis , and foot fracture , all in bevacizumab-treated patients ) , and one grade @ treatment-related event ( vaginal haemorrhage , in a patient treated with standard chemotherapy ) were reported .


Bevacizumab , added to platinum-based chemotherapy , did not increase overall survival in the study population as a whole .


However , an overall survival benefit was recorded in poor-prognosis patients , which is concordant with the progression-free survival results from ICON@ and GOG-@ , and provides further evidence towards the optimum use of bevacizumab in the treatment of ovarian cancer .


Renal stones are common disorders that affect approximately @ % to @ % of the population and the incidence of renal stones is rising .


Treatment of ureteral stones is an important part of urologists and minimally invasive procedures such as ESWL and ureteroscopy effectiveness has been proven in various studies .


However , these methods are not completely safe and are expensive and can be complicated .


Purpose of this study is to evaluate the effectiveness of tamsulosin in the medical treatment of distal ureteral stones .


A total of @ patients with distal ureteral stones or UVj are randomly divided into two study group ( @ patients ) and control group ( @ patients ) .


Patients in the control group allowed to freely consuming fluids ( hydration ) and indomethacin @ mg PRN .


Study group in addition to indomethacin and daily analgesic @ mg tamsulosin was administered .


All subjects in terms of analgesic dose , duration of expulsion and expulsion were studied .


Spontaneous expulsion of stone was occurred in @ % ( @ patients out of @ ) of control group patients and @ % ( @ patients out of @ ) that there was no significant difference ( P > @ ) .


Average time to fix the stone in control group @ @ days ( range @ to @ days ) and in the study group , @ @ days ( range @ to @ days ) is significantly different ( P > @ ) .


The average amount of analgesic consumption in the control group was @ @ and in the study group was @ @ that showed significant differences ( P < @ ) .


In this study , although the addition of tamsulosin to conservative treatment of distal ureteral stones in the distal ureteral stone expulsion showed no significant difference between the two groups , but the reduction in the duration of expulsion , reduce pain and reduce the need for analgesic has been beneficial .


Artemisinin-based combination therapy ( ACT ) following a confirmed parasitological diagnosis is recommended by the World Health Organization ( WHO ) and the Congolese National Malaria Control Program ( NMCP ) .


However , commitment and competence of all stakeholders ( patients , medical professionals , governments and funders ) is required to achieve effective case management and secure the `` useful therapeutic life '' of the recommended drugs .


The health seeking behaviour of patients and health care professionals ' practices for malaria management were assessed .


This was an observational study embedded in a two-stage cluster randomized survey conducted in one health centre ( HC ) in each of the @ selected health zones in Kinshasa city .


All patients with clinical malaria diagnosis were eligible .


Their health seeking behaviour was recorded on a specific questionnaire , as well as the health care practitioners ' practices .


The last were not aware that their practices would be assessed .


Six hundred and twenty four patients were assessed , of whom @ ( @ % ) were under five years .


Three hundred and thirty five ( @ % ) had taken medication prior to the current consultation ( self - medication with any product or visiting another HC ) of whom @ ( @ % ) took an antimalarial drug , and @ ( @ % ) were treated presumptively .


Among those , @ % received monotherapy either with quinine , artesunate , phytomedicines , sulfadoxine-pyrimethamine or amodiaquine .


On the other side , when clinicians were informed about laboratory results , monotherapy was prescribed in @ % of the confirmed malaria cases .


Only @ patients ( @ % ) were managed in line with WHO and NMCP guidelines , of whom @ ( @ % ) were prescribed an ACT after positive blood smear and @ ( @ % ) received no antimalarial after a negative result .


This study shows the discrepancy between malaria policies and the reality on the field in Kinshasa , regarding patients ' health seeking behaviour and health professionals ' practices .


Consequently , the poor compliance to the policies may contribute to the genesis and spread of antimalarial drug resistance and also have a negative impact on the burden of the disease .


Chinese Americans are at increased risk for hepatitis B virus ( HBV ) infection .


To reduce or eliminate disparities in HBV-related infection rates , participation in scientific investigations of HBV risk and treatment , including biospecimen sampling , is important .


However , Asian Americans have low rates of participation in biospecimen research , and little is known about how educational interventions affect knowledge and participation in HBV-related biospecimen research .


Eight Chinese community-based organizations participated in a quasi-experimental , two-group design with education assessments at pre - and postworkshop and a @-month follow-up .


Four sites were randomly assigned to receive the intervention ( n = @ ) and four sites to receive general health education ( control ; n = @ ) .


Participant knowledge about biospecimen research increased from pre - to posteducation in the intervention but not in the control condition .


Of intervention participants , @ % ( @/@ ) donated one tube of blood for future HBV biospecimen research , and @ % ( @/@ ) donated another tube of blood for HBV testing .


In contrast , only @ % of participants in the control condition reported donating a blood sample at follow-up assessment .


The intervention program significantly increased knowledge of and participation in HBV biospecimen research among Chinese Americans .


Community-based participatory research ( CBPR ) methods featured active support by community leaders , a culturally specific curriculum , and convenient , immediate access to blood sampling , which resulted in high donation rates .


HBV-related morbidity and mortality is an urgent problem faced by Chinese Americans .


CBPR provides a model for engaging communities in early detection , vaccination , and treatment that can reduce this health threat .


Bronchospasm results in airway obstruction in horses with heaves .


Atropine is the most potent bronchodilator drug currently available for horses , but is associated with side effects that limit its use .


Like atropine , N-butylscopolammonium bromide ( NBB ) is an anticholinergic agent with bronchodilatory properties .


To compare the bronchodilating effects and side effects of atropine and NBB in horses with heaves .


Cross-over experiment using horses with heaves .


Eight horses with heaves were administered atropine and NBB , using a cross-over design .


Heart rate , pupillary dilatation , transrectal palpation , lung mechanics ( maximal changes in transpulmonary pressure , pulmonary resistance and elastance ) and arterial blood gases were assessed before and @ and @min after drug administration .


One horse treated with atropine developed colic .


Significant pupillary dilatation was observed only with atropine .


Tachycardia developed in all horses , but was more marked with atropine .


Lung function improved with both drugs , but elastance values had returned to baseline at @min with NBB .


There was no improvement in arterial hypoxaemia with either drug .


The study indicated that the bronchodilatory properties of NBB were not statistically different from those of atropine , but were of shorter duration .


N-butylscopolammonium bromide was associated with fewer systemic side effects , and therefore NBB should be preferred over atropine when assessing the reversibility of airway obstruction in horses .


To assess driving ability ( brake response time -LSB- BRT -RSB- ) with commonly used knee braces .


Sixty-four healthy participants ( @ women and @ men ) participated in our study .


BRT was assessed using a custom-made driving simulator .


We assessed BRT for @ different commonly used knee braces ( right leg ) used in @ different settings : without a knee brace ( control group ) ; with a typical postoperative knee brace with adjustable range of motion ( ROM ) and the settings of @ to @ , @ to @ , @ to @ , and @ to @ ( extension and flexion ) ; and with an unloading knee brace for moderate to severe unicompartmental osteoarthritis , an orthosis for ligament instabilities , a knee brace for patellofemoral disorders , and an elastic knee bandage .


The @ participants ( mean age , @ years ) showed significantly impaired BRT with the typical postoperative brace set at an ROM of @ to @ ( @ milliseconds , P < @ ) , ROM of @ to @ ( @ milliseconds , P < @ ) , ROM of @ to @ ( @ milliseconds , P = @ ) , and ROM of @ to @ ( @ milliseconds , P = @ ) compared with the control group .


However , no such impaired BRT was found for any other investigated knee brace .


Right-sided ROM-restricting knee braces involve significant impairment of BRT in healthy participants .


No such prolonged BRT was found for a patellofemoral realignment brace , a ligament brace , a valgus/osteoarthritis brace , or an elastic knee bandage .


However , our findings should be viewed in light of the limitations of the study , which are ( @ ) the lack of a defined decrease in BRT that could lead to an accident and ( @ ) uncertainty of whether the statistical differences are also clinically important .


Level II , lesser-quality randomized controlled trial .


We previously demonstrated the feasibility and clinical effectiveness of a web-based assessment following total hip or total knee arthroplasty .


The purpose of the present study was to conduct an economic evaluation to compare a web-based assessment with in-person follow-up .


Patients who had undergone total joint arthroplasty at least twelve months previously were randomized to complete a web-based follow-up or visit the clinic for the usual follow-up .


We recorded travel costs and time associated with each option .


We followed patients for one year after the web-based or in-person follow-up evaluation and documented any resource use related to the joint arthroplasty .


We conducted cost analyses from the health-care payer ( Ontario Ministry of Health and Long-Term Care ) and societal perspectives .


All costs are presented in @ Canadian dollars .


A total of @ patients ( @ in the web-based group , @ in the usual-care group ) completed the study .


The mean cost of the assessment from the societal perspective was $ @ per patient for the web-based assessment and $ @ per patient for the usual method of in-person follow-up .


The cost for the web-based assessment was significantly lower from the societal perspective ( mean difference , $ -@ ; @ % confidence interval -LSB- CI -RSB- , $ -@ to $ -@ ; p < @ ) and also from the health-care payer perspective ( mean difference , $ -@ ; @ % CI , $ -@ to $ -@ ; p < @ ) .


The web-based follow-up assessment had a lower cost per patient compared with in-person follow-up from both societal and health-care payer perspectives .


Despite aggressive local therapy , patients with locally advanced bladder cancer have a significant risk of distant metastases .


This study evaluated the role of neoadjuvant combination chemotherapy with gemcitabine/cisplatin ( GC ) in improving the outcome of this group of patients over radical cystectomy alone .


A total of @ patients with newly diagnosed bladder cancer ( T@-@ , N@-@ , M@ ) were randomized to radical cystectomy alone or initial @ cycles of GC , then managed according to response .


Patients who achieved complete response completed @ cycles of GC followed by local radiation therapy ( RT ) only .


If tumors were downstaged to T@ , complete transurethral resection was done , followed by @ cycles of GC and then RT. .


Patients with partial response underwent radical cystectomy followed by @ cycles of GC .


Patients with stable disease or disease progression underwent radical cystectomy .


The overall response rate to GC was @ % , and complete response was achieved in @ % .


The @-year overall survival ( OS ) was @ % versus @ % in the chemotherapy and surgery arms , respectively ( P = @ ) .


The @-year disease-free survival was @ % in the chemotherapy arm and @ % in the surgery arm ( P = @ ) .


Bladder preservation was achieved in @ % of patients in the neoadjuvant arm .


OS was @ % in responding patients and @ % in patients with complete response .


Neoadjuvant GC did not improve survival in locally advanced bladder cancer over radical cystectomy alone .


However , bladder preservation was feasible , and OS in responding patients was impressive .


Therefore , predictive models to select patients are needed .


This is the largest prospective study of squamous cell carcinoma and transitional cell carcinoma using neoadjuvant GC .


Fragile X syndrome ( FXS ) is an inherited neurodevelopmental condition characterised by behavioural , learning disabilities , physical and neurological symptoms .


In addition , an important degree of comorbidity with autism is also present .


Considered a rare disorder affecting both genders , it first becomes apparent during childhood with displays of language delay and behavioural symptoms.Main aim : To show whether the combination of @ mg/kg/day of ascorbic acid ( vitamin C ) and @ mg/kg/day of - tocopherol ( vitamin E ) reduces FXS symptoms among male patients ages @ to @ years compared to placebo treatment , as measured on the standardized rating scales at baseline , and after @ and @ weeks of treatment.Secondary aims : To assess the safety of the treatment .


To describe behavioural and cognitive changes revealed by the Developmental Behaviour Checklist Short Form ( DBC-P@ ) and the Wechsler Intelligence Scale for Children-Revised .


To describe metabolic changes revealed by blood analysis .


To measure treatment impact at home and in an academic environment .


A phase II randomized , double-blind pilot clinical trial .


male children and adolescents diagnosed with FXS , in accordance with a standardized molecular biology test , who met all the inclusion criteria and none of the exclusion criteria .


clinical data , blood analysis , Wechsler Intelligence Scale for Children-Revised , Conners parent and teacher rating scale scores and the DBC-P@ results will be obtained at the baseline ( t@ ) .


Follow up examinations will take place at @ weeks ( t@ ) and @ weeks ( t@ ) of treatment .


A limited number of clinical trials have been carried out on children with FXS , but more are necessary as current treatment possibilities are insufficient and often provoke side effects .


In the present study , we sought to overcome possible methodological problems by conducting a phase II pilot study in order to calculate the relevant statistical parameters and determine the safety of the proposed treatment .


The results will provide evidence to improve hyperactivity control and reduce behavioural and learning problems using ascorbic acid ( vitamin C ) and - tocopherol ( vitamin E ) .


The study protocol was approved by the Regional Government Committee for Clinical Trials in Andalusia and the Spanish agency for drugs and health products .


To investigate the effect of regular aerobic training and postexercise protein-carbohydrate supplementation in patients with facioscapulohumeral muscular dystrophy ( FSHD ) .


In this randomized , double-blind , placebo-controlled parallel study , we randomized untrained men ( n = @ ) and women ( n = @ ) with FSHD ( age @-@ years ) to @ training groups-training with protein supplement ( n = @ ) and training with placebo supplement ( n = @ ) - and a nonintervention control group ( n = @ ) .


We assessed fitness , walking speed , muscle strength , questionnaires , and daily activity levels before and after @ weeks of interventions .


Training involved @ sessions of @-minute cycle-ergometer training .


After each session , patients drank either a protein-carbohydrate or placebo beverage .


In the trained participants , fitness , workload , and walking speed improved ( @ % -LSB- confidence interval ( CI ) @ % -@ % -RSB- , @ % -LSB- CI @ % -@ % -RSB- , @ % -LSB- CI @ % -@ % -RSB- , respectively , p < @ , number needed to treat = @ ) .


Self-assessed physical capacity and health ( Short Form-@ ) also improved .


Muscle strength and daily activity levels did not change with training .


Protein-carbohydrate supplementation did not result in further improvements in any tests compared to training alone .


This randomized , controlled study showed that regular endurance training improves fitness , walking speed , and self-assessed health in patients with FSHD without causing muscle damage .


Postexercise protein-carbohydrate supplementation does not add any further improvement to training effects alone .


This study provides Class II evidence that regular aerobic training with or without postexercise protein-carbohydrate supplementation improves fitness and workload in patients with FSHD .


Iodine deficiency in infants can damage the developing brain and increase mortality .


Present recommendations state that oral iodised oil should be given to breastfeeding mothers to correct iodine deficiency in infancy when iodised salt is not available , and that direct supplementation should be given to infants who are not being breastfed or receiving iodine-fortified complimentary foods .


However , there is little evidence for these recommendations .


We aimed to assess the safety and efficacy of direct versus indirect supplementation of the infant .


We did this double blind , randomised , placebo-controlled trial in Morocco .


Healthy breastfeeding mothers and their term newborn babies ( aged @ weeks ) were block randomised by clinic day to receive either : one dose of @ mg iodine to the mother and placebo to the infant ( indirect infant supplementation ) , or one dose of about @ mg iodine to the infant and placebo to the mother ( direct infant supplementation ) .


Randomisation was masked to participants and investigators .


Coprimary outcomes were : maternal and infant urinary iodine concentrations , breastmilk iodine concentration , maternal and infant thyroid-stimulating hormone ( TSH ) concentrations , maternal and infant thyroxine ( T@ ) concentrations , and infant growth .


These outcomes were measured at baseline , and when infants were aged about @ months , @ months , and @ months , and the two groups were compared using mixed effects models .


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


We recruited @ mother-infant pairs between Feb @ , and Aug @ , @ , and completed data collection by Aug @ , @ .


At baseline , median urinary iodine concentration was @ g/L ( IQR @-@ ) in mothers and @ g/L ( @-@ ) in infants , suggesting iodine deficiency .


During the study , maternal urinary iodine concentration ( p = @ ) , breastmilk iodine concentration ( p < @ ) , and infant urinary iodine concentration ( p = @ ) were higher in the indirect infant supplementation group than in the direct supplementation group .


Maternal TSH ( p = @ ) and T@ ( p = @ ) concentrations did not differ between the groups over the course of the study , nor did infant TSH ( p = @ ) and T@ ( p = @ ) concentrations , but the number of infants with thyroid hypofunction was lower ( p = @ ) in the indirect supplementation group than the direct supplementation group .


The infant groups did not differ in anthropomorphic measures , except that length-for-age Z score was slightly greater in the direct infant supplementation group ( p = @ ) .


At @ months and @ months of age , median infant urinary iodine concentration in the indirect infant supplementation group was sufficient ( > @ g/L ) , whereas infant urinary iodine concentration was sufficient only at @ months in the direct supplementation group .


There were no serious adverse events in either group .


In regions of moderate-to-severe iodine deficiency without effective salt iodisation , lactating women who receive one dose of @ mg iodine as oral iodised oil soon after delivery can provide adequate iodine to their infants through breastmilk for at least @ months , enabling the infants to achieve euthyroidism .


Direct supplementation is less effective in improving infant iodine status .


The intention of the PEPCAD China ISR ( A Prospective , Multicenter , Randomized Trial of Paclitaxel-Coated versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis ) was to demonstrate the efficacy of paclitaxel-coated balloon ( PCB ) angioplasty in a non-European patient population with coronary drug-eluting stent in-stent restenosis ( DES-ISR ) .


The treatment of DES-ISR is still challenging with no established best strategy .


Moreover , there is no study on the effect of PCB in the treatment of ISR in the Chinese population .


PEPCAD China ISR was a @-patient randomized ( @:@ ) , single-blind prospective multicenter trial conducted in China .


Patients with coronary DES-ISR received either PCB ( SeQuent Please , B. Braun Melsungen AG , Melsungen , Germany ) or paclitaxel-eluting stent ( Taxus Libert , Boston Scientific , Natick , Massachusetts ) treatment .


The primary endpoint was in-segment late lumen loss at @ months .


There were no significant baseline differences between both treatment groups in terms of patient , lesion , or procedural characteristics .


At @ months , in-segment late lumen loss in the PCB group was noninferior to that of the paclitaxel-eluting stent group ( @ @ mm vs. @ @ mm ; difference : -@ mm with @ % confidence interval : -@ to @ ; p for noninferiority = @ ) .


The @-month rate of binary restenosis and @-month composite clinical event rates were not significantly different between groups .


In a randomized trial of @ patients , angioplasty with a PCB was noninferior to paclitaxel-eluting stent implantation when used to treat DES-ISR .


On the basis of these , as well as previous randomized trial data , PCB angioplasty offers an effective treatment for DES-ISR without the necessity of implanting additional metal layers for drug release .


( A Safety and Efficacy Study of Paclitaxel-Eluting Balloon to Paclitaxel-Eluting Stent -LSB- PEPCAD -RSB- ; NCT@ ) .


Four-factor prothrombin complex concentrates ( PCCs ) , which contain factorII , FVII , FIX , and FX , have shown the potential to reverse the anticoagulant effect of rivaroxaban in healthy volunteers .


The purpose of this study was to determine whether a three-factor PCC , which contains little FVII , has a similar effect .


We performed an open-label , single-center , parallel-group study comparing the effect of a three-factor PCC ( ProfilnineSD ) with that of a four-factor PCC ( BeriplexP/N ) on the pharmacodynamics of rivaroxaban in @ healthy volunteers .


After receiving @days of rivaroxaban @mg twice daily to obtain supratherapeutic steady-state concentrations , volunteers were randomized to receive a single @IUkg ( -@ ) bolus dose of four-factor PCC , three-factor PCC or saline @h after the morning dose of rivaroxaban on day@ , and the effects of these interventions on prothrombin time and thrombin generation were determined .


Within @min , four-factor PCC reduced mean prothrombin time by @-@ @ s , whereas three-factor PCC produced only a @-@ @ - s reduction .


In contrast , three-factor PCC reversed rivaroxaban-induced changes in thrombin generation more than four-factor PCC .


This study demonstrates the potential of both three-factor and four-factor PCCs to at least partially reverse the anticoagulant effects of rivaroxaban in healthy adults .


The discrepant effects of the PCC preparations may reflect differences in the procoagulant components present in each .


Dental care is a significant unmet health care need for children with autism spectrum disorders ( ASD ) .


Many children with ASD do not receive dental care because of fear associated with dental procedures ; oftentimes they require general anesthesia for regular dental procedures , placing them at risk of associated complications .


Many children with ASD have a strong preference for visual stimuli , particularly electronic screen media .


The use of visual teaching materials is a fundamental principle in designing educational programs for children with ASD .


To determine if an innovative strategy using @ types of electronic screen media was feasible and beneficial in reducing fear and uncooperative behaviors in children with ASD undergoing dental visits .


We conducted a randomized controlled trial at Boston Children 's Hospital dental clinic .


Eighty ( @ ) children aged @ to @ years with a known diagnosis of ASD and history of dental fear were enrolled in the study .


Each child completed @ preventive dental visits that were scheduled @ months apart ( visit @ and visit @ ) .


After visit @ , subjects were randomly assigned to @ of @ groups : ( @ ) group A , control ( usual care ) ; ( @ ) group B , treatment ( video peer modeling that involved watching a DVD recording of a typically developing child undergoing a dental visit ) ; ( @ ) group C , treatment ( video goggles that involved watching a favorite movie during the dental visit using sunglass-style video eyewear ) ; and ( @ ) group D , treatment ( video peer modeling plus video goggles ) .


Subjects who refused or were unable to wear the goggles watched the movie using a handheld portable DVD player .


During both visits , the subject 's level of anxiety and behavior were measured using the Venham Anxiety and Behavior Scales .


Analyses of variance and Fisher 's exact tests compared baseline characteristics across groups .