Whether these effects will be continued in longer duration of treatment remains to be determined .


Gestational diabetes ( GDM ) confers a high risk of type @ diabetes .


In the Diabetes Prevention Program ( DPP ) , intensive lifestyle ( ILS ) and metformin prevented or delayed diabetes in women with a history of GDM .


The objective of the study was to evaluate the impact of ILS and metformin intervention over @ years in women with and without a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study .


This was a randomized controlled clinical trial with an observational follow-up .


The study was conducted at @ clinical centers .


Three hundred fifty women with a history of GDM and @ women with previous live births but no history of GDM participated in the study .


The participants had an elevated body mass index and fasting glucose and impaired glucose tolerance at study entry .


Interventions included placebo , ILS , or metformin .


Outcomes measure was diabetes mellitus .


Over @ years , women with a history of GDM assigned to placebo had a @ % higher risk of developing diabetes compared with women without a history of GDM .


In women with a history of GDM , ILS and metformin reduced progression to diabetes compared with placebo by @ % and @ % , respectively .


Among women without a history of GDM , ILS reduced the progression to diabetes by @ % , and metformin did not reduce the progression to diabetes .


Women with a history of GDM are at an increased risk of developing diabetes .


In women with a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study , both lifestyle and metformin were highly effective in reducing progression to diabetes during a @-year follow-up period .


Among women without a history of GDM , lifestyle but not metformin reduced progression to diabetes .


Minority race and lower socioeconomic status are associated with poorer patient ratings of health care quality and provider communication .


To examine the association of race/ethnicity or socioeconomic status with patients ' and families ' ratings of end-of-life care and communication about end-of-life care provided by physicians-in-training .


As a component of a randomized trial evaluating a program designed to improve clinician communication about end-of-life care , patients and patients ' families completed preintervention survey data regarding care and communication provided by internal medicine residents and medical subspecialty fellows .


We examined associations between patient and family race or socioeconomic status and ratings they gave trainees on two questionnaires : the Quality of End-of-Life Care ( QEOLC ) and Quality of Communication ( QOC ) .


Patients from racial/ethnic minority groups , patients with lower income , and patients with lower educational attainment gave trainees higher ratings on the end-of-life care subscale of the QOC ( QOCeol ) .


In path models , patient educational attainment and income had a direct effect on outcomes , while race/ethnicity did not .


Lower family educational attainment was also associated with higher trainee ratings on the QOCeol , while family non-white race was associated with lower trainee ratings on the QEOLC and general subscale of the QOC .


Patient race is associated with perceptions of the quality of communication about end-of-life care provided by physicians-in-training , but the association was opposite to our hypothesis and appears to be mediated by socioeconomic status .


Family member predictors of these perceptions differ from those observed for patients .


Further investigation of these associations may guide interventions to improve care delivered to patients and families .


Roller massagers are used as a recovery and rehabilitative tool to initiate muscle relaxation and improve range of motion ( ROM ) and muscular performance .


However , research demonstrating such effects is lacking .


To determine the effects of applying a roller massager for @ and @ seconds on knee-joint ROM and dynamic muscular performance .


Randomized controlled clinical trial .


University laboratory .


Ten recreationally active men ( age = @ @ years , height = @ @ cm , mass = @ @ kg ) .


Participants performed @ randomized experimental conditions separated by @ to @ hours .


In condition @ ( @ repetitions of @ seconds ) and condition @ ( @ repetitions of @ seconds ) , they applied a roller massager to the quadriceps muscles .


Condition @ served as a control condition in which participants sat quietly .


Visual analog pain scale , electromyography ( EMG ) of the vastus lateralis ( VL ) and biceps femoris during roller massage and lunge , and knee-joint ROM .


We found no differences in pain between the @-second and @-second roller-massager conditions .


During @ seconds of roller massage , pain was @ % ( @ @ ) and @ % ( @ @ ) greater at @ seconds and @ seconds , respectively , than at @ seconds ( P < @ ) .


During roller massage , VL and biceps femoris root mean square ( RMS ) EMG was @ % and @ % , respectively , of RMS EMG recorded during maximal voluntary isometric contraction .


Knee-joint ROM was @ % and @ % greater in the @-second and @-second roller-massager conditions , respectively , than the control condition ( P < @ ) .


Finally , average lunge VL RMS EMG decreased as roller-massage time increased ( P < @ ) .


Roller massage was painful and induced muscle activity , but it increased knee-joint ROM and neuromuscular efficiency during a lunge .


Intensive care units ( ICU ) are epicenters for the emergence of antibiotic-resistant Gram-negative bacteria ( ARGNB ) because of high rates of antibiotic usage , rapid patient turnover , immunological susceptibility of acutely ill patients , and frequent contact between healthcare workers and patients , facilitating cross-transmission .


Antibiotic stewardship programs are considered important to reduce antibiotic resistance , but the effectiveness of strategies such as , for instance , antibiotic rotation , have not been determined rigorously .


Interpretation of available studies on antibiotic rotation is hampered by heterogeneity in implemented strategies and suboptimal study designs .


In this cluster-randomized , crossover trial the effects of two antibiotic rotation strategies , antibiotic mixing and cycling , on the prevalence of ARGNB in ICUs are determined .


Antibiotic mixing aims to create maximum antibiotic heterogeneity , and cycling aims to create maximum antibiotic homogeneity during consecutive periods .


This is an open cluster-randomized crossover study of mixing and cycling of antibiotics in eight ICUs in five European countries .


During cycling ( @ months ) third - or fourth-generation cephalosporins , piperacillin-tazobactam and carbapenems will be rotated during consecutive @-week periods as the primary empiric treatment in patients suspected of infection caused by Gram-negative bacteria .


During mixing ( @ months ) , the same antibiotics will be rotated for each consecutive antibiotic course .


Both intervention periods will be preceded by a baseline period of @ months .


ICUs will be randomized to consecutively implement either the mixing and then cycling strategy , or vice versa .


The primary outcome is the ICU prevalence of ARGNB , determined through monthly point-prevalence screening of oropharynx and perineum .


Secondary outcomes are rates of acquisition of ARGNB , bacteremia and appropriateness of therapy , length of stay in the ICU and ICU mortality .


Results will be adjusted for intracluster correlation , and patient - and ICU-level variables of case-mix and infection-prevention measures using advanced regression modeling .


This trial will determine the effects of antibiotic mixing and cycling on the unit-wide prevalence of ARGNB in ICUs .


The current study was performed to evaluate whether baseline acute and chronic prostate inflammation among men with an initial negative biopsy for prostate cancer ( PCa ) increased the risk of subsequent PCa detection in a clinical trial with systematic biopsies .


A retrospective analysis was performed of @ men aged @ years to @ years with prostate-specific antigen levels between @ ng/mL and @ ng/mL and a prior negative biopsy in the REduction by DUtasteride of PCa Events study who completed a @-year biopsy .


PCa , acute prostate inflammation , and chronic prostate inflammation were assessed by central review .


The association between inflammation in baseline prostate biopsies and positive @-year and @-year repeat biopsies was evaluated with the chi-square test and logistic regression analysis adjusting for baseline covariates .


Acute and chronic inflammation and both were detected in @ baseline biopsies ( @ % ) , @ baseline biopsies ( @ % ) , and @ baseline biopsies ( @ % ) , respectively .


Acute and chronic inflammation were found to be significantly associated with each other ( P < @ ) .


Acute inflammation at baseline biopsy was associated with younger age , lower prostate-specific antigen levels , and a smaller prostate ( all P < @ ) , whereas chronic inflammation was associated with older age and larger prostate glands ( all P < @ ) .


At the @-year biopsy , the prevalence of PCa was @ % ( N = @ patients ) .


On univariable and multivariable analysis , both acute and chronic inflammation were found to be significantly associated with a lower PCa risk ( acute univariable : odds ratio -LSB- OR -RSB- , @ -LSB- P < @ -RSB- and multivariable : OR , @ -LSB- P = @ -RSB- and chronic univariable : OR , @ -LSB- P < @ -RSB- and multivariable : OR , @ -LSB- P < @ -RSB- ) .


At the time of @-year biopsy , only acute inflammation was found to be associated with a lower PCa risk .


Baseline acute and chronic inflammation were both found to be independently associated with a lower PCa risk .


From a clinical standpoint , inflammation in negative biopsies for PCa may lower the risk of subsequent PCa detection .


The benefits of rehabilitation after immobilization for ankle fracture are unclear .


To determine the effectiveness of a supervised exercise program and advice ( rehabilitation ) compared with advice alone and to determine if effects are moderated by fracture severity or age and sex .


The EXACT trial was a pragmatic , randomized clinical trial conducted from December @ to June @ .


Patients with isolated ankle fracture presenting to fracture clinics in @ Australian hospitals were randomized on the day of removal of immobilization .


Of @ eligible patients , @ chose not to participate and @ were allocated to rehabilitation ( n = @ ) or advice alone ( n = @ ) , with @ ( @ % ) followed up at @ month , @ ( @ % ) at @ months , and @ ( @ % ) at @ months .


There were no withdrawals attributed to adverse effects .


Recruitment terminated early on December @ , @ ( planned enrollment , @ ; actual , @ ) , because funding was exhausted .


Supervised exercise program and advice about self-management ( rehabilitation ) ( individually tailored , prescribed , monitored , and progressed ) or advice alone , both delivered by a physical therapist .


Primary outcomes were activity limitation assessed using the Lower Extremity Functional Scale ( score range , @-@ ; higher scores indicate better activity ) , and quality of life assessed using the Assessment of Quality of Life ( score range , @-@ ; higher scores indicate better quality of life ) , measured at baseline and at @ , @ ( primary time point ) , and @ months .


Mean activity limitation and quality of life at baseline were @ ( SD , @ ) and @ ( SD , @ ) , respectively , for advice and @ ( SD , @ ) and @ ( SD , @ ) for rehabilitation , increasing to @ ( SD , @ ) and @ ( SD , @ ) for advice vs @ ( SD , @ ) and @ ( SD , @ ) for rehabilitation at @ months .


Rehabilitation was not more effective than advice for activity limitation ( mean effect at @ months , @ -LSB- @ % CI , -@ to @ -RSB- ) or quality of life ( -@ -LSB- @ % CI , -@ to @ -RSB- ) .


Treatment effects were not moderated by fracture severity or age and sex .


A supervised exercise program and advice did not confer additional benefits in activity limitation or quality of life compared with advice alone for patients with isolated and uncomplicated ankle fracture .


These findings do not support the routine use of supervised exercise programs after removal of immobilization for patients with isolated and uncomplicated ankle fracture .


To investigate the efficacy and safety of Ji-Tai tablet and Ji-Tai tablet combined with buprenorphine in the treatment of patients with acute withdrawal syndrome of mild heroin dependence .


A total of @ patients with mild heroin dependence were recruited , and were randomly assigned to a Ji-Tai tablet group ( n = @ ) , a Ji-Tai tablet combined with buprenorphine group ( n = @ ) and a control group ( n = @ ) during a @-day clinical trial .


Opiate withdrawal scale ( OWS ) was used to measure the severity of withdrawal symptoms .


Anxiety symptoms assessments were made at @ day ( baseline ) , the day @ ( middle ) , and the day @ ( end ) by the Hamilton anxiety scale ( HAMA ) .


Symptoms were assessed before and @ h or @ h after medication each day .


The total withdrawal symptoms scores and the daily reduction rate were used to measure the effect of Ji-Tai tablet vs Ji - Tai tablet plus buprenorphine .


Safety evaluation was carried out by the following measures : baseline of treatment , drug side effects after the treatment , vital signs ( blood pressure , heart rate , and respiration rate ) , laboratory examination ( routine blood and urine tests and the liver and kidney function tests ) , and electrocardiograms .


A total of @ mild heroin dependence patients performed the experiments ( including @ in the Ji-Tai tablet group , @ in the Ji-Tai tablet with buprenorphine group and @ in the control group ) .


The scores of baseline withdrawal symptoms were @ , @ and @ , respectively , with no significant differences among the @ groups ( all P > @ ) .


During the @-day treatment , the reduction rate of acute withdrawal symptoms scores increased daily , the acute withdrawal syndrome scores and the anxiety symptoms scores declined from day @ to day @ , there was also no significant difference among the @ groups ( all P > @ ) .


Ji-Tai tablet did not affect vital signs such as blood pressure , heart rate , and respiration rate .


Ji-Tai tablet or Ji-Tai tablet combined with buprenorphine had no effect on acute withdrawal symptoms of mild heroin dependence .


Human infection with the avian influenza A H@N@ virus results in disease with a high fatality rate , against which antiviral treatments have limited efficacy .


We aimed to investigate the safety , pharmacokinetics , and therapeutic potential of specific polyclonal immunoglobulin equine F ( ab ' ) fragments raised against influenza A/Vietnam/@ / @ virus ( H@N@ subtype ) in healthy volunteers .


We did a randomised , double-blind , placebo-controlled , single-centre phase @ study .


In stage @ ( one infusion ) and stage @ ( five infusions ) of the trial , we randomly assigned healthy male volunteers to receive once-daily intravenous infusions of @ U/kg body weight of F ( ab ' ) or once-daily saline placebo .


Randomisation was done centrally , with one block of four patients and one block for substitutes ( three actives , one placebo ) in stage @ , and two blocks of six patients ( five actives and one placebo ) and the same block for substitutes in stage @ .


The primary objective was assessment of the clinical and laboratory safety of F ( ab ' ) , which was monitored for @ days in the group that received one dose ( assessments on days @-@ , @ , @ , @ , and @ ) and @ days in the group that received five doses ( days @-@ , @ , @ , @ , @ , @ , and @ ) .


A final post-study safety assessment was done at @ days .


We also assessed pharmacokinetic outcomes , and assayed haemagglutination and seroneutralisation activity .


Analysis was done according to intention-to-treat .


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


We enrolled @ healthy Asian men between Sept @ and Dec @ , @ , and randomly assigned @ to one or five doses of F ( ab ' ) and three to placebo .


F ( ab ' ) was well tolerated , and no deaths or serious adverse events occurred .


Three patients had mild adverse events ( one each of blepharospasm , sinusitis , and pyrexia ) .


The pyrexia ( @C ) was regarded as probably related to the infusion , and resolved after @ min .


Our laboratory assessments of blood and urine samples and physical examinations of heart rate , electrocardiogram readings , and weight showed no clinically significant safety issues .


Mean peak plasma concentrations were @ g/mL ( SD @ ) with the one dose schedule and @ g/mL ( @ ) with the five-dose schedule .


F ( ab ' ) were still detectable in plasma on average up to @ days after five doses .


Haemagglutination inhibition was only increased after the third dose , but in-vitro seroneutralisation activity was transiently increased after each of the five doses to concentrations regarded as clinically beneficial in infected patients .


F ( ab ' ) showed good safety , tolerability , and therapeutic potential for managing of H@N@ exposed patients .


Declining inspiratory muscle function and structure and systemic low-level inflammation and oxidative stress may contribute to morbidity and mortality during normal ageing .


Therefore , we examined the effects of inspiratory muscle training ( IMT ) in older adults on inspiratory muscle function and structure and systemic inflammation and oxidative stress , and reexamined the reported positive effects of IMT on respiratory muscle strength , inspiratory muscle endurance , spirometry , exercise performance , physical activity levels ( PAL ) , and quality of life ( QoL ) .


Thirty-four healthy older adults ( @ @ yr ) with normal spirometry , respiratory muscle strength , and physical fitness were divided equally into a pressure-threshold IMT or sham-hypoxic placebo group .


Before and after an @-wk intervention , measurements were taken for dynamic inspiratory muscle function and inspiratory muscle endurance using a weighted plunger pressure-threshold loading device ; diaphragm thickness by using B-mode ultrasonography ; plasma cytokine concentrations by using immunoassays ; DNA damage levels in peripheral blood mononuclear cells by using comet assays ; spirometry , maximal mouth pressures , and exercise performance by using a @-min walk test ; PAL by using a questionnaire and accelerometry ; and QoL using a questionnaire .


Compared with placebo , IMT increased maximal inspiratory pressure ( +@ % @ % , P = @ ) , diaphragm thickness at residual volume ( +@ % @ % , P = @ ) , and peak inspiratory flow ( +@ % @ % , P = @ ) but did not change other spirometry measures , plasma cytokine concentrations , DNA damage levels in peripheral blood mononuclear cells , dynamic inspiratory muscle function , inspiratory muscle endurance , exercise performance , PAL , or QoL .


These novel data indicate that in healthy older adults , IMT elicits some positive changes in inspiratory muscle function and structure but neither attenuates systemic inflammation and oxidative stress nor improves exercise performance , PAL , or QoL .


To be an older woman , live alone , have chronic pain , and be dependent on support are all factors that may have an impact on daily life .


One way to promote ability in everyday activities in people with pain-related conditions is to use individualized , integrated behavioral medicine in physical therapy interventions .


How this kind of intervention works for older women living alone at home , with chronic pain , and dependent on formal care to manage their everyday lives has not been studied .


The aim was to explore the feasibility of a study and to evaluate an individually tailored integrated behavioral medicine in physical therapy intervention for the target group of women .


The study was a @-week randomized trial with two-group design .


Primary effect outcomes were pain-related disability and morale .


Secondary effect outcomes focused on pain-related beliefs , self-efficacy for exercise , concerns of falling , physical activity , and physical performance .


In total , @ women agreed to participate in the study and @ women completed the intervention .


The results showed that the behavioral medicine in physical therapy intervention was feasible .


No effects were seen on the primary effect outcomes .


The experimental intervention seemed to improve the level of physical activity and self-efficacy for exercise .


Some of the participants in both groups perceived that they could manage their everyday life in a better way after participation in the study .


Results from this study are encouraging , but the study procedure and interventions have to be refined and tested in a larger feasibility study to be able to evaluate the effects of these kinds of interventions on pain-related disability , pain-related beliefs , self-efficacy in everyday activities , and morale in the target group .


Further research is also needed to refine and evaluate effects from individualized reminder routines , support to collect self-report data , safety procedures for balance training , and training of personnel to enhance self-efficacy .


Although cilnidipine and valsartan are widely coadministered to patients with hypertension , their drug-drug interaction potential has not been investigated .


This study compared the pharmacokinetic ( PK ) , pharmacodynamic ( PD ) , and tolerability profiles of cilnidipine and valsartan , both alone and in combination , in healthy male subjects .


Fifty-four subjects , enrolled into an open-label , single-dose , three-treatment , three-period crossover study , randomly received cilnidipine ( @ mg ) , valsartan ( @ mg ) , or both according to one of six sequences .


Blood samples were collected at baseline and up to @ hours after drug administration in each period .


Plasma concentrations of cilnidipine and valsartan were determined by liquid chromatography with tandem mass spectrometry .


Maximum plasma concentration ( Cmax ) and area under the concentration-time curve from @ to the last measurable time ( AUC ( last ) ) were estimated using a noncompartmental method .


Tolerability was evaluated by assessing adverse events ( AEs ) , vital signs , electrocardiograms , and clinical laboratory tests .


Blood pressure was also measured for PD assessment .


A total of @ subjects completed the study .


The PK profile of cilnidipine was not significantly affected by coadministered valsartan ; the geometric mean ratio and @ % confidence interval ( @ % CI ) of AUC ( last ) for cilnidipine with and without valsartan was @ ( @-@ @ ) .


Likewise , cilnidipine did not affect the PK of valsartan ; the geometric mean ratio ( @ % CI ) of AUC ( last ) for valsartan with and without cilnidipine was @ ( @-@ @ ) .


Coadministration of cilnidipine and valsartan reduced blood pressure in an additive way .


No serious AEs were reported , and both cilnidipine and valsartan were well tolerated .


Coadministered cilnidipine and valsartan do not cause a significant PK or PD interaction , and they are well tolerated .


Little is known about the necessity of multiple same-day intraocular pressure ( IOP ) measurements in describing the effect of IOP-lowering surgical procedures , and such evidence could affect surgical trial recruitment and retention of participants .


To determine whether a single IOP measurement might adequately approximate the mean of several measurements in glaucoma surgical trials .


A prospective , multicenter , interventional cohort from the prerandomization phase of a randomized clinical trial evaluating use of a supraciliary implant for treatment of IOP was conducted at multiple ophthalmology clinics .


A total of @ patients ( @ eyes ) with primary open-angle glaucoma and cataract were included .


One IOP measurement was made while patients were receiving their usual medications to lower IOP , and @ IOP measurements were made at @ am , @ pm , and @ pm after patients underwent washout of all IOP-lowering eyedrops .


The proportion of eyes in which the increase in IOP after washout , using the mean of the @ measurements , differed by more than @ , @ , @ , or @ mm Hg from the increase in IOP after washout using only @ of the postwashout measurements .


A proportion of @ % or less at the @-mm Hg cutoff was considered clinically acceptable .


The hypothesis was formulated after data collection but before the data were examined .


The mean ( SD ) IOP before washout was @ ( @ ) mm Hg .


The mean increase in IOP after washout , using the mean of the @ measurements , was @ ( @ ) mm Hg .


The percentage of eyes in which the increase in IOP using a single postwashout IOP differed from the increase in IOP using the mean of @ measurements by more than @ mm Hg was @ % , @ % , @ % , @ % , and @ % when the single measurement was made at @ am , @ pm , @ pm , a randomly chosen single measure of those @ times , and the time closest to that of the prewashout IOP , respectively .


By logistic regression , the @ pm postwashout IOP had the lowest proportion of eyes differing from the mean ( P < @ ) and thus most closely approximated the mean diurnal IOP .


Although eliminating multiple IOP measurements would simplify the conduct of surgical trials in glaucoma , our data show that using a single IOP measurement after washout does not adequately approximate the mean of multiple IOP measurements .


To evaluate the clinical and ultrasonographic changes in the morphology and vascularity of the common extensor tendon after injecting platelet-rich plasma ( PRP ) or corticosteroid ( CS ) for recalcitrant lateral epicondylitis ( LE ) .


@ patients aged @ to @ years with recalcitrant ( > @ months ) LE not responsive to oral medication or non-invasive treatment were randomised to receive PRP ( n = @ ) or CS ( n = @ ) injection .


Patients were assessed using the visual analogue scale ( VAS ) for pain , Disabilities of the Arm , Shoulder and Hand Scale ( DASH ) score , Oxford Elbow Score , modified Mayo Clinic performance index for the elbow ( modified Mayo score ) , and hand grip strength .


Ultrasonography was performed by a musculoskeletal ultrasonologist to evaluate for tear at the common extensor origin , oedema at the common extensor origin , cortical erosion , probe-induced tenderness , and thickness of the tendon .


The VAS for pain , DASH score , Oxford Elbow Score , modified Mayo score , and hand grip strength all improved significantly from pre-injection to the @-month follow-up in the PRP and CS groups .


However , in the CS group , the scores generally peaked at @ months and then deteriorated slightly at @ months indicating recurrence of symptoms , which involved @ % of the CS patients .


At @ months , the number of patients positive for various ulrasonographic findings generally decreased .


However , in the CS group , the number of patients with reduced thickness of the common extensor tendon increased from @ to @ , and the number of patients with cortical erosion at the lateral epicondyle increased from @ to @ .


PRP appeared to enable biological healing of the lesion , whereas CS appeared to provide short-term , symptomatic relief but resulted in tendon degeneration .


To assess vitamin D status of pediatric patients with Crohn 's disease ( CD ) and to compare their serum @-hydroxyvitamin D ( s-@OHD ) with established cutoffs and assess whether @ months of supplementation with @ IU/d , vs @ IU/d , would reduce the group prevalence of vitamin D below these cutoffs .


Subjects @-@ years ( n = @ ) with quiescent CD were randomized to either @ or @ IU vitamin D@/d for @ months .


Baseline mean SD s-@OHD was @ @ ng/mL ; @ subjects ( @ % ) had an s-@OHD < @ ng/mL , @ ( @ % ) < @ ng/mL , and @ ( @ % ) < @ ng/mL .


There was no significant difference between groups in achieving the cutoffs of @ ng/mL or @ ng/mL at @ months ; however , only @ % of the @ IU group achieved the greater cutoff of @ ng/mL compared with @ % in the @ IU group ( P < @ ) .


Baseline adjusted mean s-@OHD concentrations at @ months were @ ng/mL ( @ % CI @-@ @ , P < @ ) greater in the @ IU than the @ IU group .


Disease activity was not affected by supplement dose .


Few subjects exceeded safety marker cutoffs , and this did not differ by dose .


At baseline , a high proportion of patients had a mean s-@OHD > @ ng/mL .


@ IU vitamin D@/d is more effective in raising s-@OHD concentrations to > @ ng/mL in children with CD than @ IU/d , but both treatments were equally effective at achieving @ or @ ng/mL .


Cerebral injury caused by hypoperfusion during the perioperative period is one of the main causes of disability and death in patients after major surgery .


No effective protective or preventative strategies have been identified .


This study was designed to evaluate the effects of Ginkgo biloba extract on cerebral oxygen and glucose metabolism in elderly patients with known , pre-existing cerebral ischemia .


Sixty ASA ( American Society of Anesthesiologists ) II-III patients , diagnosed with vertebral artery ischemia by transcranial Doppler ultrasonography ( TCD ) , and scheduled for elective total hip replacement surgery , were enrolled in the study .


They were randomly allocated to receive either @mg/kg Ginkgo biloba extract ( G group n = @ ) or normal saline ( D group n = @ ) after induction of anesthesia .


Blood samples were collected from radial artery and jugular venous bulb catheters for blood gas analysis and determination of glucose and lactate concentrations preoperatively , before surgical incision , at the end of surgery , and on post-op day @ .


Arterial O@ content ( CaO@ ) , jugular venous O@ content ( CjvO@ ) , arteriovenous O@ content difference ( Da-jvO@ ) , cerebral oxygen extraction rate ( CEO@ ) , and arteriovenous glucose and lactate content differences ( Da-jvGlu and Da-jvLac ) were calculated .


There were no significant differences in CaO@ or Da-jvGlu during surgery between groups ( p > @ ) .


However , the Ginkgo group had higher CjvO@ , internal jugular venous oxygen saturation ( SjvO@ ) and lower CEO@ , Da-jvO@ and Da-jvLac at the end of surgery ( T@ ) and on post-op day @ ( T@ ) than those in the control group ( p < @ ) .


Ginkgo biloba extract can improve cerebral oxygen supply , decrease cerebral oxygen extraction rate and consumption , and help maintain the balance between cerebral oxygen supply and consumption .


It has no effect , however , on cerebral glucose metabolism in elderly patients with known , pre-existing cerebral ischemia .


Myocardial deformation analysis by speckle-tracking echocardiography ( STE ) has been shown to accurately predict viability in patients with chronic ischemic left ventricular ( LV ) dysfunction .


The aim of this study was to evaluate two-dimensional STE for the prediction of global and segmental LV functional changes after acute myocardial infarction ( AMI ) in comparison with late gadolinium enhancement ( LGE ) cardiac magnetic resonance ( CMR ) .


In @ patients ( mean age , @ @ years ) with first AMIs ( @ with ST-segment elevation myocardial infarctions and @ with non-ST-segment elevation myocardial infarctions ) treated with acute percutaneous coronary intervention , global peak longitudinal strain was determined to describe global function by STE , and peak systolic circumferential and longitudinal strain was determined for segmental function analysis .


LGE CMR was performed to define the amounts of global and segmental myocardial scar .


STE and LGE CMR were performed within @ hours of AMI .


At @-month follow-up , transthoracic echocardiography was repeated to determine global und segmental LV recovery and adverse LV remodeling ( increase in end-systolic volume > @ % ) .


Accuracy to predict global functional improvement as well as LV remodeling at @-month follow-up after AMI was similar for STE and LGE CMR ( areas under the curve , @ vs @ -LSB- P = @ -RSB- and @ vs @ -LSB- P = @ -RSB- , respectively ) .


Peak systolic circumferential strain < -@ % had sensitivity of @ % and specificity of @ % to predict segmental functional improvement .


Compared with LGE CMR , the predictive accuracy of transmural STE for segmental functional improvement at @-month follow-up was lower ( area under the curve , @ vs @ ; P = @ ) .


Predictive accuracy for segmental functional improvement could be improved by analysis of endocardial circumferential strain ( area under the curve , @ vs @ for transmural speckle-tracking echocardiographic analysis ; P = @ ) .


Two-dimensional STE allows the prediction of global functional recovery as well as LV remodeling after AMI with accuracy comparable with that of LGE CMR .


Accuracy to predict segmental functional recovery using transmural deformation analysis by two-dimensional STE is inferior compared with LGE CMR but can be improved by a layer-specific analysis of endocardial deformation .


Studies indicate an effect of dietary calcium on change in body weight ( BW ) and waist circumference ( WC ) , but the results are inconsistent .


Furthermore , a relation could depend on genetic predisposition to obesity .


The objective was to examine whether genetic predisposition to higher body mass index ( BMI ) , WC , or waist-hip ratio ( WHR ) interacts with dietary calcium in relation to subsequent annual change in BW ( BW ) and WC ( WC ) .


The study was based on @ individuals from the MONItoring trends and determinants of CArdiovascular disease Study , a sample from the Danish Diet , Cancer and Health Study and the INTER@ study , with information on diet ; @ single-nucleotide polymorphisms ( SNPs ) associated with BMI , WC , or WHR adjusted for BMI ; and potential confounders .


The SNPs were combined in @ scores as indicators of genetic predisposition ; all SNPs in a general score and a score for each of @ phenotypes : BMI , WC , and WHR .


Linear regression was used to examine the association between calcium intake and BW or WC adjusted for concurrent BW .


SNP score calcium interactions were examined by adding product terms to the models .


We found a significant BW of -@ kg ( P = @ ; @ % CI : -@ , -@ ) per @ mg Ca .


No significant association was observed between dietary calcium and WC .


In the analyses with BW as outcome , we found no significant interactions between the developed predisposition scores and calcium .


However , we found a significant interaction between a score of @ WC-associated SNPs and calcium in relation to WC .


Each risk allele was associated with a WC of -@ cm ( P = @ ; @ % CI : -@ , -@ ) per @ mg Ca .


Our study suggests that dietary calcium relates weakly to BW loss .


We found no evidence of a general association between calcium and WC , but calcium may reduce WC among people genetically predisposed to a high WC .


However , further replication of this finding is needed .


We aimed to investigate whether combination therapy using intracoronary ( IC ) abciximab and aspiration thrombectomy ( AT ) enhances myocardial perfusion compared to each treatment alone in patients with ST-elevation myocardial infarction ( STEMI ) undergoing primary percutaneous coronary intervention ( PCI ) .


We enrolled @ patients with STEMI , who presented within @ h of symptom onset and had Thrombolysis in MI flow @/@ or a large angiographic thrombus burden ( grade @/@ ) .


Patients were randomly divided into @ groups : @ patients who received a bolus of IC abciximab ( @ mg/kg ) ; @ patients who received only AT ; and @ patients who received both treatments .


The index of microcirculatory resistance ( IMR ) was measured with a pressure sensor/thermistor-tipped guidewire following successful PCI .


Microvascular obstruction ( MVO ) was assessed using cardiac magnetic resonance imaging on day @ .


IMR was lower in the combination group than in the IC abciximab group ( @ U vs. @ U , p = @ ) and tended to be lower than in the AT group , with barely missed significance ( @ U vs. @ U , p = @ ) .


MVO was observed less frequently in the combination group than in the IC abciximab group ( @ % vs. @ % , p = @ ) and tended to occur less frequently than in the AT group ( @ % vs. @ % , p = @ ) .


No difference of IMR and MVO was found between the IC abciximab and the AT group ( @ U vs. @ U , p = @ for IMR ; @ % vs. @ % , p = @ for MVO , respectively ) .


Combination treatment using IC abciximab and AT may synergistically improve myocardial perfusion in patients with STEMI undergoing primary PCI ( Trial Registration : clinicaltrials .


gov Identifier : NCT@ ) .


Polyetheretherketone ( PEEK ) cages have been widely used in the treatment of lumbar degenerative disc disorders , and show good clinical results .


Still , complications such as subsidence and migration of the cage are frequently seen .


A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible .


Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities , and therefore are expected to lower complication rates and allow for better fusion.Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages .


This study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis .


@ patients ( @-@ years ) presenting with symptomatic lumbar degenerative disorders unresponsive to at least @ months of conservative treatment are included .


Patients will be randomly assigned to a PEEK cage or a silicon nitride cage , and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation .


Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire .


Secondary outcome parameters are the VAS leg , VAS back , SF-@ , Likert scale , neurological outcome and radiographic assessment of fusion .


After @ year the fusion rate will be measured by radiograms and CT. .


Follow-up will be continued for @ years .


Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up .


Analyses of radiograms and CT will be performed independently by two experienced radiologists .


In this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders .


To our knowledge , this is the first randomized controlled trial in which the silicon nitride cage is compared with the PEEK cage in patients with symptomatic degenerative lumbar disc disorders .


Yoga is a popular mind-body therapy that has demonstrated beneficial effects on psychological , behavioral , and functional outcomes .


However , few studies have investigated effects on inflammatory processes .


This study tested the hypothesis that an Iyengar yoga intervention specifically designed for fatigued breast cancer survivors would lead to decreases in inflammation-related gene expression and circulating markers of proinflammatory cytokine activity .


Breast cancer survivors with persistent cancer-related fatigue were randomized to a @-week Iyengar yoga intervention ( n = @ ) or a @-week health education control condition ( n = @ ) .


Blood samples were collected at baseline , post-intervention , and at a @-month follow-up for genome-wide transcriptional profiling and bioinformatic analyses .


Plasma inflammatory markers and salivary cortisol were also assessed .


In promoter-based bioinformatics analyses , the yoga group showed reduced activity of the pro-inflammatory transcription factor nuclear factor kappa B ( NF-B ) , increased activity of the anti-inflammatory glucocorticoid receptor , and reduced activity of cAMP response element-binding protein ( CREB ) family transcription factors relative to controls ( all ps < @ ) .


There was also a significant intervention effect on the soluble tumor necrosis factor receptor type II ( sTNF-RII ) , a marker of TNF activity ; plasma levels of sTNF-RII remained stable in the yoga group , whereas levels of this marker increased in the health education group ( p = @ ) .


A similar , non-significant trend was observed for the interleukin @ receptor antagonist ( p = @ ) .


No significant changes in C reactive protein ( CRP ) , interleukin @ ( IL-@ ) , or diurnal cortisol measures were observed .


A @-week restorative Iyengar yoga intervention reduced inflammation-related gene expression in breast cancer survivors with persistent fatigue .


These findings suggest that a targeted yoga program may have beneficial effects on inflammatory activity in this patient population , with potential relevance for behavioral and physical health .


High left ventricular ( LV ) pacing threshold ( PT ) may in some cases indicate the presence of scarred myocardium , a predictor of poor outcome in cardiac resynchronization therapy ( CRT ) treated patients .


We hypothesized that intraoperative LVPT can be used to determine echocardiographic and clinical responses to CRT .


The study comprised @ patients enrolled in the CRT-D arm of the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) .


Multivariate regression analysis was performed to evaluate the relationship between LVPT and percent reduction in LV end-systolic volume ( ESV ) and left atrial volume ( LAV ) @ year after CRT .


Cox proportional hazards analysis was used to evaluate the relationship between LVPT and heart failure ( HF ) events or death ( primary endpoint ) and all-cause death ( secondary endpoint ) .


An increasing LVPT was inversely related to percent reduction in both LVESV ( P = @ ) and LAV ( P < @ ) .


Patients with LVPT in the highest quartile ( > @ V ) were less likely to achieve reverse LV remodeling ( @ % LVESV reduction from baseline ) than those with LVPT in the lower quartiles ( hazard ratios -LSB- HR -RSB- OR @ , P = @ ) .


Mean percent reduction in LAV and LVESV was also significantly greater among those with lowest quartile LVPT .


Multivariate analysis showed borderline significant @ % ( P = @ ) and significant @ % ( P = @ ) increase in the risk of HF/death and death alone , respectively , per @ volt increase in LVPT .


High intraoperative LVPT is associated with significantly lower echocardiographic and clinical response to CRT-D .


Insulin resistance plays a central role in the pathophysiology of metabolic syndrome ( MS ) .


Its cardiac deleterious effects are characterized by an increase in fibrous tissue that increases myocardial stiffness and contributes to subclinical left ventricular diastolic dysfunction ( LVDD ) and heart failure with preserved ejection fraction in patients with MS. In addition to lifestyle counseling ( LC ) , metformin treatment may attenuate or even reverse diastolic dysfunction in these patients .


This trial aims to evaluate if treating non-diabetic patients with MS and LVDD with metformin in addition to LC improves diastolic function and assess its impact in functional capacity and health-related quality of life ( HRQoL ) .


MET-DIME is a phase II prospective , randomized , open-label , blinded-endpoint trial with a scheduled follow-up of @months .


Fifty-four patients ( adults @-@years old with AHA/NHLBI criteria of MS and rest LVDD ) will be randomized by minimization to LC only or LC plus metformin ( target dose of @,@ mg twice daily ) .


The primary endpoint will be change in mean of early diastolic mitral annular velocity , an echocardiographic parameter highly correlated with myocardial fibrosis ( serial measurements will be performed at @ , @ and @months ) .


The secondary endpoints will include change in diastolic parameters at rest ; metabolic , inflammatory and remodeling biomarkers ; functional capacity ; adipose tissue volumes and HRQoL .


MET-DIME is a pragmatic trial designed to evaluate if adding metformin to the standard treatment of patients with MS improves diastolic dysfunction , assessing its impact in metabolic homeostasis , proinflammatory state , functional capacity and HRQoL .


EndoTAG-@ , composed of paclitaxel embedded in liposomal membranes targeting tumor endothelial cells , was evaluated for safety and efficacy in advanced triple-negative breast cancer ( TNBC ) .


One hundred and forty patients were treated with weekly EndoTAG-@ ( @ mg/m ( @ ) ) plus paclitaxel ( @ mg/m ( @ ) ) , twice weekly EndoTAG-@ ( @ @ mg/m ( @ ) ) , or weekly paclitaxel ( @ mg/m ( @ ) ) for greater than or equal to four cycles ( @-week treatment + @-week rest ) or until progression/toxicity .


Primary end point was progression-free survival ( PFS ) rate evaluated centrally after four cycles of therapy ( week @ ) .


The study was not powered for intergroup comparisons .


The PFS rate at week @ was @ % -LSB- one-sided @ % CI : @ , -RSB- on combination treatment , @ % -LSB- @ , -RSB- on EndoTAG-@ , and @ % -LSB- @ , -RSB- on paclitaxel .


Median PFS reached @ , @ , and @ months , respectively .


After complete treatment ( week @ analysis ) , median overall survival ( OS ) was @ , @ , and @ months for the modified Intention-to-Treat ( ITT ) population and @ , @ , and @ months for the per-protocol population , respectively .


The clinical benefit rate was @ % , @ % , and @ % for the treatment groups .


Safety analysis revealed known toxicities of the drugs with slight increases of grade @/@ neutropenia on combination therapy .


Treatment of advanced TNBC with a combination of EndoTAG-@ and standard paclitaxel -LSB- Taxol ( Bristol-Myers Squibb GmbH ) , or equivalent generic formulation -RSB- was well tolerated and showed antitumor efficacy .


The positive trend needs to be confirmed in a randomized phase III trial .


To compare the difference in the clinical efficacy on infantile Tourette syndrome between the integrated therapy of acupuncture and pingganjianpi decoction and haloperidol tablets .


Forty-seven children were randomized into an observation group ( @ cases ) and a control group ( @ cases ) .


In the observation group , acupuncture was applied to Taichong ( LR @ ) , Baihui ( GV @ ) , Zhongwan ( CV @ ) , Zusanli ( ST @ ) , etc. .


The needles were retained for @ min .


Acupuncture was given once a day and there were @ days at intervals after @ times of acupuncture .


Additionally , pinggan jianpi decoction was prescribed .


In the control group , haloperidol tablets were prescribed , starting from the small dose , @ mg/kg per day , twice a day .


The treatment of @ days made one session and @ sessions were required .


Yale global tic severity scale ( YGTSS ) was adopted to observe tic time , tic frequency and tic severity score before treatment and in @ days , @ days and @ days after treatment in the two groups .


The efficacy and adverse reactions were compared between the two groups .


The total effective rates were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) in the observation group and were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) in the control group in @ days , @ days and @ days after treatment respectively .


The effect in @ days after treatment in the control group was better than that in the observation group ( P < @ ) .


The differences at the other time points were not significant between the two groups ( all P > @ ) .


The tic time , tic frequency and tic severity score at the each time point after treatment were reduced obviously as compared with those before treatment ( all P < @ ) .


Each item score in the control group was reduced obviously as compared with that in the observation group in @ days after treatment ( all P < @ ) .


The probability of adverse reaction in the observation group was less than that in the control group .


The integrated therapy of acupuncture and medicine achieves the similar effect on infantile Tourette syndrome to haloperidol tablets and the side effects of it are less .


Faldaprevir is a potent , once-daily hepatitis C virus ( HCV ) NS@/@A protease inhibitor .


STARTVerso@ assessed the efficacy and safety of faldaprevir and response-guided pegylated interferon -@ a/ribavirin ( PegIFN/RBV ) in individuals with HCV/HIV co-infection .


A phase @ open-label study ( NCT@ ) .


Individuals ( N = @ ) co-infected with HCV genotype @ ( treatment-naive or prior interferon relapsers ) and HIV -LSB- @ % on antiretroviral therapy ( ART ) -RSB- received faldaprevir @mg ( N = @ ) or @mg ( N = @ ) and PegIFN/RBV .


Those receiving a protease inhibitor or efavirenz ART were assigned to faldaprevir @ or @mg , respectively .


Individuals achieving early treatment success ( ETS ; HCV RNA < @IU/ml at week @ and undetectable at week @ ) were randomized to @ or @ weeks of PegIFN/RBV .


The primary endpoint was sustained virologic response @ weeks after treatment ( SVR@ ) .


SVR@ was achieved in @ ( @ % ) individuals , and the rates were comparable across faldaprevir doses .


ETS was achieved in @ % , and of these @ % achieved SVR@ , with comparable rates with @ and @ weeks of PegIFN/RBV ( @ and @ % , respectively ) .


In multivariate analysis , age below @ years , IL@B CC genotype , and baseline HCV RNA below @IU/ml were associated with SVR@ ( P = @ , P < @ , and P = @ , respectively ) , whereas treatment ( ART regimen and faldaprevir dose ) , liver cirrhosis , and genotype @ subtype were not .


The safety profile was comparable to that of faldaprevir in HCV-monoinfected individuals .


High SVR@ rates were achieved with faldaprevir and PegIFN/RBV in HIV/HCV co-infected individuals , regardless of faldaprevir dose and background ART , HCV genotype @ subtype , or cirrhosis status .


SVR rates mirrored those obtained with similar regimens in HCV monoinfected individuals .


To compare the short-term clinical performance of two dual-disinfectant multipurpose disinfecting solutions ( MPDS ) when used in conjunction with two silicone hydrogel contact lenses .


Participants wore galyfilcon A and balafilcon A lenses , randomly allocated one type to each eye .


Multipurpose disinfecting solutions were double-masked and allocated using a randomized crossover design .


Lenses were presoaked overnight in the allocated MPDS , containing either polyquaternium-@ / alexidine dihydrochloride ( PQ-alexidine ) or polyquaternium-@ / myristamidopropyl dimethylamine ( PQ-MAPDA ) .


Lenses were worn daily for @ days and disinfected with the same MPDS in which they had been soaked .


Clinical assessments occurred immediately after insertion , @ hours after insertion , and after @ hours of wear on day @ .


Subjective ratings were collected at each assessment and after @ hours of wear on days @ to @ .


Linear mixed models were used for statistical analysis .


Solution-induced corneal staining ( SICS ) incidence was significantly different between MPDS lens combinations ( P = @ ) with PQ-MAPDA-balafilcon A showing the highest incidence ( @ % ) .


The incidence of SICS was significantly higher when balafilcon A lenses were worn compared with galyfilcon A ( @ % vs. @ % ; P = @ ) .


There was no significant difference in SICS incidence between MPDS ( PQ-alexidine = @ % , PQ-MAPDA = @ % ; P = @ ) .


Polyquaternium-@ / alexidine dihydrochloride was associated with significantly fewer symptoms of burning/stinging ( @ vs. @ ; P = @ ) and self-assessed redness ( @ vs. @ ; P = @ ) on initial lens insertion .


There were no significant differences between MPDS for comfort ratings ( P > @ ) .


These short-term clinical results provide an initial indication that PQ-alexidine is associated with fewer symptoms on insertion but no significant difference in ocular comfort compared with PQ-MAPDA .


Longer studies are required to provide further evidence .


Acute radiation cystitis , inflammation of the bladder , is a common side effect in men receiving external beam radiation for prostate cancer .


Although several treatments provide symptomatic relief , there is no effective treatment to prevent or treat radiation cystitis .


Cranberry products have been associated with urinary tract health .


This study aimed to determine the effect of highly standardized cranberry capsules ( containing @ mg proanthocyanidins -LSB- PACS -RSB- ) compared with that of placebo capsules on the incidence and severity of radiation cystitis .


Forty-one men with prostate cancer participated in a double blinded randomized placebo controlled study .


Men took one capsule a day at breakfast during treatment and for @ weeks after treatment completion .


Severity of urinary symptoms and the bother these caused were measured using the individual items of the urinary domain of the Modified Expanded Prostate Index Composite ( EPIC ) .


The incidence of cystitis was lower in men taking cranberry capsules ( @ % ) compared with those that took placebo capsules ( @ % ) ( p = @ ) ; severe cystitis was seen in @ % of men in the cranberry arm and @ % in the placebo arm ( p = @ ) .


Overall , the incidence of pain/burning was significantly lower in the cranberry cohort ( p = @ ) .


Men on the low hydration regimen who took cranberry had less pain/burning ( p = @ ) , stronger urine steam ( p = @ ) and used significantly fewer pads/liners ( p = @ ) , which was significantly different from those on the high hydration regimen ( p = @ ) .


Men receiving radiation therapy for prostate cancer may benefit from using cranberry capsules , particularly those on low hydration regimens or with baseline urinary symptoms .


Endoscopic minimally invasive surgery of the cervical region is currently used to treat benign thyroid disease .


The aim of this study was to evaluate the safety , feasibility , and inflammatory response to endoscopic thyroidectomy ( ET ) via an anterior chest wall approach .


Between January @ and January @ , @ patients underwent sub-total/total thyroidectomy .


Of these , @ had endoscopic surgery through an anterior chest wall approach ( ET , group A ) and @ had traditional open surgery ( group B ) .


Demographics , operation time , intraoperative blood loss , complications , hospital stay , cost , and postoperative outcomes were compared between the @ groups .


Serum Interleukin-@ and C-reactive protein levels were measured preoperatively and at @ , @ , @ , and @ hours postoperatively .


Patient demographics , tumor size , operation time , and pathologic diagnoses were similar in both groups .


There was no difference in procedure time and postoperative complication rates .


Intraoperative blood loss and length of hospital stay were significantly lower in group A ( P < @ ) , but cost was higher ( P < @ ) .


Serum Interleukin-@ and C-reactive protein levels increased significantly after both procedures , with levels at the @-hour and @-hour time points higher in group B ( P < @ ) .


Two cases in group A and @ in group B developed a transient hoarse voice postoperatively , which recovered @ days ( range , @ to @ d ) later .


There were no serious complications during the @-year follow-up .


ET through an anterior chest wall approach is safe and feasible for benign thyroid disease , and offers the advantage of no visible scar .


The BELOB study , a randomised controlled phase @ trial comparing lomustine , bevacizumab and combined lomustine and bevacizumab in patients with recurrent glioblastoma , showed that the @-month overall survival rate was most promising in the combination arm .


Here we report the health-related quality of life ( HRQoL ) results , a secondary trial end-point .


HRQoL was measured at baseline and every @weeks until progression using the European Organisation for Research and Treatment of Cancer ( EORTC ) core questionnaire ( QLQ-C@ ) and brain module ( QLQ-BN@ ) .


HRQoL was assessed over time for five preselected scales ( global health ( GH ) , physical ( PF ) and social functioning ( SF ) , motor dysfunction ( MD ) and communication deficit ( CD ) ) .


Moreover , mean changes in HRQoL from baseline until progression were determined .


@/@ patients with at least a baseline HRQoL assessment were analysed .


Over time , HRQoL remained relatively stable in all treatment arms for all five scales , at least during the first three treatment cycles .


More than half ( @-@ % ) of the patients showed stable ( < @ point change ) or improved ( @ point change ) HRQoL during their progression-free time , except for SF ( @ % ) , irrespective of treatment arm .


Deterioration of mean HRQoL was most profound at disease progression for all scales except SF , which deteriorated earlier in disease course .


Compared to baseline , @ % of patients had clinically relevant ( @ points ) worse GH , PF and SF , while @ % and @ % had increased MD and CD at disease progression , irrespective of treatment arm .


Bevacizumab , whether or not in combination with lomustine , did not negatively affect HRQoL in patients treated for recurrent glioblastoma in this randomised study .


To investigate the efficacy , safety , and tolerability of empagliflozin in patients with type @ diabetes and hypertension .


Patients ( N = @ ) with type @ diabetes and hypertension ( mean seated systolic blood pressure -LSB- SBP -RSB- @-@ mmHg and diastolic blood pressure -LSB- DBP -RSB- @-@ mmHg ) were randomized ( double blind ) to @ mg or @ mg empagliflozin or placebo once daily for @ weeks .


At week @ , adjusted mean difference versus placebo in change from baseline in mean @-h SBP ( ambulatory blood pressure monitoring -LSB- ABPM -RSB- ) was -@ mmHg ( @ % CI -@ , -@ ) with @ mg empagliflozin and -@ mmHg ( -@ , -@ ) with @ mg empagliflozin ( both P < @ ) .


At week @ , adjusted mean difference versus placebo in change from baseline in mean @-h DBP ( ABPM ) was -@ mmHg ( @ % CI -@ , -@ ) with @ mg empagliflozin and -@ mmHg ( @ % CI -@ , -@ ) with @ mg empagliflozin ( both P < @ ) .


Changes in office BP were consistent with ABPM .


Adjusted mean difference versus placebo in change from baseline in HbA@c at week @ was -@ % ( @ % CI -@ , -@ ) ( -@ mmol/mol -LSB- @ % CI -@ , -@ -RSB- ) with @ mg empagliflozin and -@ % ( @ % CI -@ , -@ ) ( -@ mmol/mol -LSB- @ % CI -@ , -@ -RSB- ) with @ mg empagliflozin ( both P < @ ) .


Empagliflozin was well tolerated .


One patient on placebo and one patient on @ mg empagliflozin reported events consistent with volume depletion .


Empagliflozin was associated with significant and clinically meaningful reductions in BP and HbA@c versus placebo and was well tolerated in patients with type @ diabetes and hypertension .


To observe the impact on lower limbs balance function in treatment of yin-yang meridians acupuncture with respiratory reinforcing and reducing manipulation involved in the patients of stroke by applying B-PHY balance function test training system so as to provide the objective evidence in treatment of stroke ; with acupuncture .


One hundred patients were randomized into an observation group and a control group , @ cases in each one .


In the control group , the basic treatment was applied , without other relevant rehabilitation therapies associated .


In the observation group , with the basic treatment as the control group 's , the therapy of the yin-yang meridians acupuncutre with respiratory reinforcing and reducing manipulation was adopted .


On the yin meridians , Zuwuli ( LR @ ) , Xuehai ( SP @ ) , Yinlingquan ( SP @ ) , Sanyinjiao ( SP @ ) and the others were selected and stimulated with reducing manipulation achieved by the coordination of patient 's respiration .


On the yang meridians , Biguan ( ST @ ) , Liangqiu ( ST @ ) , Yanglingquan ( GB @ ) and the others were selected and stimulated with reinforcing manipulation achieved by the coordination of patient 's respiration .


The treatment was given once a day and for @ days totally .


Before treatment and in @ days of treatment , B-PHY balance function test training system was used to determine the weight shift track parameters ( track length , peripheral square , track length of per unit square , left-right offset and rectangle square ) , the weight shift track distance parameters -LSB- mean of X axle weight shift distance ( Mean-X ) , mean of Y axle weight shift distance ( Mean-Y ) , maximum of X axle weight shift distance ( Max-X ) , maximum of Y axle weight shift distance ( Max-Y ) , weight shift distance ( LSKG ) , weight shift square ( SSKG ) , square ratio of weight shift ( LFS ) -RSB- , stability coefficient ( SI ) and weight distribution coefficient ( WDI ) .


After treatment , the differences in the weight shift track parameters , SI and WDI were significant as compared with those before treatment in the patients of the two groups ( all P < @ ) ; while the differences in the weight shift distance parameters in the observation group were improved obviously after treatment as compared with those before treatment ( all P < @ ) , the differences of Mean-X , Max-Y and LFS in the control group were improved after treatment as compared with those before treatment ( all P < @ ) .


Except SSKG , the improvements after treatment in the rest indices in the observation group were better than those in the control group ( all P < @ ) .


The yin-yang meridians acupuncture with respiratry reinforcing and re - ducing manipulation effectively improves the lower limbs balance function in the patients of stroke .


Although the cause in most cases of childhood leukemia is not known , the contribution of environmental risk factors in the context of genetic predisposition has been reported with inconsistent results .


The aim of this study was to examine association of childhood leukemia with maternal factors especially during pregnancy , to help in avoiding risk factors .


This case-control study included children younger than @ years diagnosed with leukemia from @ to @ .


Controls were randomly selected and individually matched to cases with respect to age , sex , and residency .


All variables were compared between cases and control to determine any significant association with leukemia .


Statistically significant associations between risk of childhood leukemia with mother 's education ( p = @ ) , occupation ( p = @ ) and pesticides exposure ( p = @ ) during pregnancy were found .


However , there were no significant links with maternal age ( p = @ ) , history of fetal loss ( @ ) , history of radiography during pregnancy ( p = @ ) , history of drug intake ( p = @ ) and infection ( p = @ ) during pregnancy .


The results showed increased risk of leukemia in children whose mothers were working in agriculture and were exposed to pesticides during pregnancy .


The further study needs to be investigated to know association of various maternal risk factors with leukemia which remained unknown in this study .


Inflammatory biomarkers predict incident and recurrent cardiac events , but their relationship to stroke prognosis is uncertain .


We hypothesized that high-sensitivity C-reactive protein ( hsCRP ) predicts recurrent ischemic stroke after recent lacunar stroke .


Levels of Inflammatory Markers in the Treatment of Stroke ( LIMITS ) was an international , multicenter , prospective ancillary biomarker study nested within Secondary Prevention of Small Subcortical Strokes ( SPS@ ) , a phase III trial in patients with recent lacunar stroke .


Patients were assigned in factorial design to aspirin versus aspirin plus clopidogrel , and higher versus lower blood pressure targets .


Patients had blood samples collected at enrollment and hsCRP measured using nephelometry at a central laboratory .


Cox proportional hazard models were used to calculate hazard ratios ( HRs ) and @ % confidence intervals ( @ % CIs ) for recurrence risks before and after adjusting for demographics , comorbidities , and statin use .


Among @ patients with lacunar stroke ( mean age , @ years ) , median hsCRP was @ mg/L .


There were @ recurrent ischemic strokes ( including @ lacunes ) and @ major vascular events ( stroke , myocardial infarction , and vascular death ) .


Compared with the bottom quartile , those in the top quartile ( hsCRP > @ mg/L ) were at increased risk of recurrent ischemic stroke ( unadjusted HR , @ ; @ % CI , @-@ @ ) , even after adjusting for demographics and risk factors ( adjusted HR , @ ; @ % CI , @-@ @ ) .


hsCRP predicted increased risk of major vascular events ( top quartile adjusted HR , @ ; @ % CI , @-@ @ ) .


There was no interaction with randomized antiplatelet treatment .


Among recent lacunar stroke patients , hsCRP levels predict the risk of recurrent strokes and other vascular events .


hsCRP did not predict the response to dual antiplatelets .


To evaluate the effectiveness of the Healthy Directions @ ( HD@ ) intervention in the primary care setting .


HD@ was a cluster randomized trial ( conducted @/@-@ / @ ) .


The primary sampling unit was provider ( n = @ ) , with secondary sampling of patients within provider ( n = @ ) .


Study arms included : @ ) usual care ( UC ) ; @ ) HD@ -- a patient self-guided intervention targeting @ risk behaviors ; and @ ) HD@ plus @ brief telephone coaching calls ( HD@ + CC ) .


The outcome measure was the proportion of participants with a lower multiple risk behavior ( MRB ) score by follow-up .


At baseline , only @ % of the participants met all behavioral recommendations .


Both HD@ and HD@ + CC led to improvements in MRB score , relative to UC , with no differences between the two HD@ conditions .


Twenty-eight percent of the UC participants had improved MRB scores at @ months , vs. @ % and @ % in HD@ and HD@ + CC , respectively ( ps @ ) ; results were similar at @ months ( p. @ ) .


The incremental cost of one risk factor reduction in MRB score was $ @ for HD@ and $ @ for HD@ + CC .


Self-guided and coached intervention conditions had equivalent levels of effect in reducing multiple chronic disease risk factors , were relatively low cost , and thus are potentially useful for routine implementation in similar health settings .


The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis .


Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery , potentially improving vessel patency by reducing restenosis .


In this single-blind , randomized trial conducted at @ sites , we assigned , in a @:@ ratio , @ patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty .


The primary efficacy end point was primary patency of the target lesion at @ months ( defined as freedom from binary restenosis or from the need for target-lesion revascularization ) .


The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at @ months from limb-related death ( i.e. , death from a medical complication related to a limb ) , amputation , and reintervention .


The two groups were well matched at baseline ; @ % of the patients had diabetes , and @ % were current smokers .


At @ months , the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty ( @ % vs. @ % , P = @ ) .


The proportion of patients free from primary safety events was @ % with the drug-coated balloon and @ % with standard angioplasty ( P = @ for noninferiority ) .


There were no significant between-group differences in functional outcomes or in the rates of death , amputation , thrombosis , or reintervention .


Among patients with symptomatic femoropopliteal peripheral artery disease , percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at @ months that was higher than the rate with angioplasty with a standard balloon .


The drug-coated balloon was noninferior to the standard balloon with respect to safety .


( Funded by Lutonix-Bard ; LEVANT @ ClinicalTrials.gov number , NCT@ . )


The intake of whey , compared with casein and soy protein intakes , stimulates a greater acute response of muscle protein synthesis ( MPS ) to protein ingestion in rested and exercised muscle .


We characterized the dose-response relation of postabsorptive rates of myofibrillar MPS to increasing amounts of whey protein at rest and after exercise in resistance-trained , young men .


Volunteers ( n = @ ) consumed a standardized , high-protein ( @ g/kg body mass ) breakfast .


Three hours later , a bout of unilateral exercise ( @ @ leg presses and leg extensions ; @ % one-repetition maximum ) was performed .


Volunteers ingested @ , @ , @ , or @ g whey protein isolate immediately ( ~ @ min ) after exercise .


Postabsorptive rates of myofibrillar MPS and whole-body rates of phenylalanine oxidation and urea production were measured over a @-h postdrink period by continuous tracer infusion of labeled -LSB- ( @ ) C@ -RSB- phenylalanine and -LSB- ( @ ) N@ -RSB- urea .


Myofibrillar MPS ( mean SD ) increased ( P < @ ) above @ g whey protein ( @ @ % / h ) by @ % and @ % with the ingestion of @ and @ g whey protein , respectively , whereas no additional stimulation was observed with @ g whey protein ( P > @ ) .


Rates of phenylalanine oxidation and urea production increased with the ingestion of @ g whey protein .


A @-g dose of whey protein is sufficient for the maximal stimulation of postabsorptive rates of myofibrillar MPS in rested and exercised muscle of ~ @-kg resistance-trained , young men .


A dose of whey protein > @ g stimulates amino acid oxidation and ureagenesis .


This trial was registered at http://www.isrctn.org/ as ISRCTN@ .


Dietary nitrate supplementation positively affects cardiovascular function at rest and energy metabolism during exercise in humans and has recently also been reported to markedly enhance the in vitro contractile properties of mouse fast-twitch muscle .


The aim of this study was to investigate the effects of short-term nitrate supplementation on the in vivo contractile properties of the skeletal muscle and voluntary muscle function of humans .


In a double-blind , randomized , crossover design , @ healthy untrained men ( @ @ yr ) ingested a nitrate-rich concentrated beetroot juice ( NIT ; nitrate dosage , approximately @ mmold ) and a placebo ( PLA ) for seven consecutive days .


After the last supplementation dose , force was recorded while participants completed a series of voluntary and involuntary ( electrically evoked ) unilateral isometric contractions of the knee extensors .


NIT enhanced the peak force response to low-frequency electrical stimulation , as follows : maximal twitch ( NIT , @ @ N , vs PLA , @ @ N ; P = @ ; effect size , r ( ES ) = @ ) and submaximal @ - to @-Hz contractions ( @ % -@ % , ES = @-@ @ ) .


Whereas explosive ( rising phase ) force production during the first @ ms of evoked maximal twitch and octet contractions ( eight electrical impulses at @ Hz ) was also @ % -@ % greater after NIT compared with that after PLA ( P = @-@ @ , ES = @-@ @ ) , explosive voluntary force remained similar ( P = @ , ES = @ ) .


Maximum voluntary force was also unchanged after NIT ( P = @ , ES = @ ) .


These results indicate that @ d of dietary nitrate supplementation enhanced the in vivo contractile properties of the human skeletal muscle .


Specifically , nitrate supplementation improved excitation-contraction coupling at low frequencies of stimulation and enhanced evoked explosive force production but did not affect maximum or explosive voluntary force production in untrained individuals .


It has been suggested that home-based heart failure ( HF ) management in primary care may be an alternative to clinic-based management in HF patients .


However , little is known about adherence to HF guidelines and adherence to the medication regimen in these home-based programmes .


The aim of the current study was to determine whether long-term follow-up and treatment in primary care is equally effective as follow-up at a specialized HF clinic in terms of guideline adherence and patient adherence , in HF patients initially managed and up-titrated to optimal treatment at a specialized HF clinic .


We conducted a multicentre , randomized , controlled study in @ HF patients ( @ % male , age @ @ years ) , who were assigned to follow-up either in primary care ( n = @ ) or in a HF clinic ( n = @ ) .


After @ months , no differences between guideline adherence , as estimated by the Guideline Adherence Indicator ( GAI-@ ) , and patient adherence , in terms of the medication possession ratio ( MPR ) , were found between treatment groups .


There was no difference in the number of deaths ( n = @ in primary care and n = @ in the HF clinic ; P = @ ) , and hospital readmissions for cardiovascular ( CV ) reasons were also similar .


The total number of unplanned non-CV hospital readmissions , however , tended to be higher in the primary care group ( n = @ ) than in the HF clinic group ( n = @ ; P = @ ) .


Patients discharged after initial management in a specialized HF clinic can be discharged to primary care for long-term follow-up with regard to maintaining guideline adherence and patient adherence .


However , the complexity of the HF syndrome and its associated co-morbidities requires continuous monitoring .


Close collaboration between healthcare providers will be crucial in order to provide HF patients with optimal , integrated care .


To assess the effect of a group-based intervention on the balance between necessity beliefs and concern beliefs about medication and on medication non-adherence in patients with rheumatoid arthritis ( RA ) .


Non-adherent RA patients using disease-modifying anti-rheumatic drugs ( DMARDs ) were randomized to an intervention or control arm .


The intervention consisted , amongst others , of two motivational interviewing-guided group sessions led by the same pharmacist .


Control patients received brochures about their DMARDs .


Questionnaires were completed up to @ months follow-up .


@ patients ( mean age : @ years , female : @ % ) were randomized .


No differences in necessity beliefs and concern beliefs about medication and in medication non-adherence were detected between the intervention and control arm , except at @ months ' follow-up : participants in the intervention arm had less strong necessity beliefs about medication than participants in the control arm ( b : -@ ( @ % CI : -@ , -@ ) ) .


This trial did not demonstrate superiority of our intervention over the control arm in changing beliefs about medication or in improving medication adherence over time .


Absent intervention effects might have been due to , amongst others , selection bias and a suboptimal treatment integrity level .


Hence , targeting beliefs about medication in clinical practice should not yet be ruled out .


To evaluate the effects of sacral magnetic stimulation ( SMS ) on functional and urodynamic improvement in patients with refractory stress urinary incontinence ( SUI ) .


A sham-controlled , double-blind , parallel study design with a @-month follow-up .


A tertiary hospital .


Women ( age , @-@y ) with SUI refractory to first-line management ( N = @ ) were allocated to either an experimental ( n = @ ) group or a sham ( n = @ ) group .


The SMS protocol consisted of @-Hz , @-minute treatments administered over the bilateral third sacral roots , with the intensity set at approximately @ % of the maximal output , for @ consecutive weekdays .


Urodynamic assessments and @ life stress questionnaires , namely , the Urge-Urinary Distress Inventory ( U-UDI ) and the Overactive Bladder Questionnaire ( OAB-q ) , were administered pre - and post-SMS intervention .


We administered the U-UDI ( primary outcome measure ) and the OAB-q at @-week intervals during the follow-up period until @ weeks after the final intervention .


The experimental group exhibited significant improvements in both U-UDI and OAB-q scores postintervention ( P = @ -@ ) and at follow-up visits ( P < @ -@ ) compared with the sham group .


In addition , significant increases in bladder capacity , urethral functional length , and the pressure transmission ratio ( P = @ -@ ) were noted postintervention .


Multivariate regression analysis revealed that patients with more severe symptoms benefited more from SMS .


A poorer baseline U-UDI score and a shorter urethral functional length were associated with a greater response to SMS .


Our observations of a greater response to SMS in patients with more severe SUI than in those with mild symptoms , as well as the long-term benefits of the treatment , confirm the efficacy of SMS in treating SUI .


To evaluate clinical efficacy of electroacupuncture at Changqiang ( GV @ ) and Chengshan ( BL @ ) @ min before surgery on postoperative pain and discomforts in patients with mixed hemorrhoids .


One hundred and twenty cases of mixed hemorrhoids who received Milligan-Morgan operation were randomly divided into an electroacupuncture group , a sham electroacupuncture group and a blank group , @ cases in each one .


At the same time of basic treatment , the electroacupuncture was applied at Changqiang ( GV @ ) and Chengshan ( BL @ ) @ min before surgery in the electroacupuncture group , while shallow needling without electrical stimulation at sham acupoint ( @ cm next to acupoint ) was applied @ min before surgery in the sham electroacupuncture group , while no treatment was given before the surgery in the blank group .


The total dose of painkillers in the first @ h after operation , the number of cases who received additional anesthetic in the operation , the self-score of most severity pain in the first @ h after operation and sleeping time in the night of surgery were observed .


The differences of the numbers of cases who received additional anesthetic in the operation had no statistical significance among the three groups ( all P > @ ) , but compared with the sham electroacupuncture group and blank group , the total dose of painkillers in the first @ h after operation was reduced in the electroacupuncture group -LSB- ( @ + / - @ ) tablets vs ( @ + / - @ ) tablets , ( @ + / - @ ) tablets -RSB- , and the score of most severity pain was also decreased ( @ + / - @ vs @ + / - @ , @ + / - @ ) , besides , the sleeping time in the night of surgery was increased -LSB- ( @ + / - @ ) min vs ( @ + / - @ ) min , ( @ + / - @ ) min , all P < @ -RSB- .


The electroacupuncture at Changqiang ( GV @ ) and Chengshan ( BL @ ) @ min before surgery has effects of preemptive analgesia on postoperative pain for patients with mixed hemorrhoids .


Evaluate the effect of intravenous fentanyl on the incidence and severity of EA .


In the clinical trial , @ patients aged between two and nine years , scheduled for elective surgery were enrolled and randomly assigned to receive either fentanyl @ microg/kg or normal saline @ ml/@ kg , @ minutes before the end of surgery .


Watcha 's behavioral emergence delirium scale was used to assess EA .


The incidence of EA was lower in the fentanyl group ( @/@ vs. @/@ person respectively , p = @ ) .


However there was no statistically significant difference in the number of patients with severe EA ( @/@ vs. @/@ person respectively , p = @ ) .


Fewer number of patients in the fentanyl group had moderate to severe pain when compared with the control group ( @/@ vs. @/@ person respectively , p = @ ) .


The number of patient who required rescue analgesia was significantly lower in the fentanyl group ( @/@ vs. @/@ person respectively , p = @ ) .


There were no statistically significant differences in terms of emergence time , postoperative adverse events , and length of stay in the post-anesthetic care unit between the two groups .


Administration of intravenous fentanyl @ microg/kg @ minutes prior the end of surgery decreased the incidence of EA and reduced pain without delaying emergence and without any increase in postoperative complications .


Abnormal choroidal blood flow is considered important in the pathogenesis of chronic central serous chorioretinopathy ( CSC ) .


Optical coherence tomography ( OCT ) angiography can image ocular blood cell flow and could thus provide novel insights in disease mechanisms of CSC .


We evaluated depth-resolved flow in chronic CSC by OCT angiography compared to fluorescein angiography ( FA ) and indocyanine green angiography ( ICGA ) .


Eighteen eyes with chronic CSC , and six healthy controls , were included .


Two human observers annotated areas of staining , hypofluorescence , and hotspots on FA and ICGA , and areas of abnormal flow on OCT angiography .


Interobserver agreement in annotating OCT angiography and FA/ICGA was measured by Jaccard indices ( JIs ) .


We assessed colocation of flow abnormalities and subretinal fluid visible on OCT , and the distance between hotspots on ICGA from flow abnormalities .


Abnormal areas were most frequently annotated in late-phase ICGA and choriocapillary OCT angiography , with moderately high ( median JI , @ ) and moderate ( median JI , @ ) interobserver agreement , respectively .


Abnormalities on late-phase ICGA and FA colocated with those on OCT angiography .


Aberrant choriocapillary OCT angiography presented as foci of reduced flow surrounded by hyperperfused areas .


Hotspots on ICGA were located near hypoperfused spots on OCT angiography ( mean distance , @ m ) .


Areas with current or former subretinal fluid were colocated with flow abnormalities .


On OCT angiography , chronic CSC showed irregular choriocapillary flow patterns , corresponding to ICGA abnormalities .


These results suggest focal choriocapillary ischemia with surrounding hyperperfusion that may lead to subretinal fluid leakage .


Psychological therapy is effective for symptoms of mental distress , but many groups with high levels of mental distress face significant barriers in terms of access to care , as current interventions may not be sensitive to their needs or their understanding of mental health .


There is a need to develop forms of psychological therapy that are acceptable to these groups , feasible to deliver in routine settings , and clinically and cost effective .


We developed a culturally sensitive wellbeing intervention with individual , group and sign-posting elements , and tested its feasibility and acceptability for patients from ethnic minorities and older people in an exploratory randomised trial .


We recruited @ patients ( @ % of our target ) from @ disadvantaged localities in the NW of England .


The results of the exploratory trial suggest that the group receiving the wellbeing interventions improved compared to the group receiving usual care .


For elders , the largest effects were on CORE-OM and PHQ-@ .


For ethnic minority patients , the largest effect was on PHQ-@ .


Qualitative data suggested that patients found the intervention acceptable , both in terms of content and delivery .


This exploratory trial provides some evidence of the efficacy and acceptability of a wellbeing intervention for older and ethnic minority groups experiencing anxiety and depression , although challenges in recruitment and engagement remain .


Evidence from our exploratory study of wellbeing interventions should inform new substantive trial designs .


Brivaracetam ( BRV ) is a novel high-affinity synaptic vesicle protein @A ligand currently being investigated for the treatment of epilepsy .


The purpose of this phase III study was to evaluate the efficacy and safety/tolerability of adjunctive BRV in adults with uncontrolled partial-onset ( focal ) seizures .


This was a prospective , multicenter , randomized , double-blind , placebo-controlled , parallel-group , fixed-dose trial ( N@ ; NCT@ ) .


Adults aged @-@ years with well-characterized partial epilepsy not fully controlled despite treatment with one or two antiepileptic drugs ( AEDs ) were enrolled .


Patients who experienced eight or more partial-onset seizures , whether or not secondarily generalized , during the @-week prospective baseline period were randomized ( @:@:@:@ ) to receive twice-daily placebo ( PBO ) or BRV ( @ , @ , or @ mg/day ) without titration .


The primary efficacy endpoint was percent reduction over PBO in baseline-adjusted partial-onset seizure frequency/week during the @-week treatment period .


Comparison of BRV with PBO was sequential ( @ , @ mg/day , then @ mg/day ) .


Secondary endpoints included @ % responder rate and median percent reduction from baseline in partial-onset seizure frequency/week .


Post hoc analyses included the primary efficacy endpoint evaluated over @ days and exploratory subanalyses of efficacy by seizure subtype .


Safety and tolerability assessments included treatment-emergent adverse events ( TEAEs ) , laboratory tests , electrocardiography , vital signs , and physical and neurologic examinations .


Of @ patients randomized , @ were included in the intent-to-treat ( ITT ) population ( PBO n = @ , BRV @ mg/day n = @ , BRV @ mg/day n = @ , BRV @ mg/day n = @ ) and @ comprised the modified ITT ( mITT ) population .


A total of @ ( @ % ) of @ patients completed the study .


Most patients ( @ % ) were receiving two concomitant AEDs .


Percent reduction in partial-onset seizure frequency/week over PBO was -@ % ( p = @ ) for BRV @ mg/day , @ % ( p = @ ) for BRV @ mg/day , and @ % ( p = @ ) for BRV @ mg/day ( mITT population ) .


Statistical significance was also achieved for the percent reduction over PBO in baseline-adjusted partial-onset seizure frequency/@ days for BRV @ mg/day ( @ % ; p = @ ) but not for the other BRV dose groups .


In the BRV @ mg/day group , statistical significance was also seen for the @ % responder rate ( BRV @ % vs. PBO @ % ; p = @ ) and median percent reduction from baseline in partial-onset seizure frequency/week ( BRV @ % vs. PBO @ % ; p = @ ) .


In the exploratory subanalysis by seizure subtype , median percent reduction from baseline in seizure frequency/week and @ % responder rate were numerically greater than PBO in the BRV @ and @ mg/day groups for simple partial , complex partial , and secondarily generalized seizures .


BRV was generally well tolerated , with the majority of TEAEs being mild-to-moderate in intensity .


Of the TEAEs reported by @ % patients , those with a frequency > @ % higher than PBO for any dose of BRV compared with PBO were somnolence , dizziness , fatigue , influenza , insomnia , nasopharyngitis , vomiting , diarrhea , urinary tract infection , and nausea .


Adjunctive BRV at a daily dose of @ mg was associated with statistically significant reductions in seizure frequency compared with PBO .


All doses of BRV showed good tolerability throughout the study .


Although several interventions have shown reduced HIV incidence in clinical trials , the community-level effect of effective interventions on the epidemic when scaled up is unknown .


We investigated whether a multicomponent , multilevel social and behavioural prevention strategy could reduce HIV incidence , increase HIV testing , reduce HIV risk behaviour , and change social and behavioural norms .


For this phase @ cluster-randomised controlled trial , @ communities in four sites in Africa and @ communities in Thailand were randomly allocated in matched pairs to receive @ months of community-based voluntary counselling and testing for HIV ( intervention group ) or standard counselling and testing alone ( control group ) between January , @ , and December , @ .


The intervention was designed to make testing more accessible in communities , engage communities through outreach , and provide support services after testing .


Randomisation was done by a computer-generated code and was not masked .


Data were collected at baseline ( n = @ @ ) and after intervention ( n = @ ) by cross-sectional random surveys of community residents aged @-@ years .


The primary outcome was HIV incidence and was estimated with a cross-sectional multi-assay algorithm and antiretroviral drug screening assay .


Thailand was excluded from incidence analyses because of low HIV prevalence .


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


The estimated incidence of HIV in the intervention group was @ % versus @ % in the control group with an estimated reduction in HIV incidence of @ % ( relative risk -LSB- RR -RSB- @ , @ % CI @-@ @ ; p = @ ) .


HIV incidence was significantly reduced in women older than @ years ( RR = @ , @-@ @ ; p = @ ) , but not in other age or sex subgroups .


Community-based voluntary counselling and testing increased testing rates by @ % overall ( @-@ ; p = @ ) , by @ % ( @-@ ; p < @ ) in men and @ % ( @-@ ; p = @ ) in women .


No overall effect on sexual risk behaviour was recorded .


Social norms regarding HIV testing were improved by @ % ( @ % CI @-@ ) in communities in the intervention group .


These results are sufficiently robust , especially when taking into consideration the combined results of modest reductions in HIV incidence combined with increases in HIV testing and reductions in HIV risk behaviour , to recommend the Project Accept approach as an integral part of all interventions ( including treatment as prevention ) to reduce HIV transmission at the community level .


Measles is a highly infectious respiratory disease which causes @,@ deaths annually .


Although measles vaccine is extremely safe and effective , vaccine coverage could be improved by a vaccine that is more easily administered and transported .


We developed an inhalable dry powder measles vaccine ( MVDP ) and two delivery devices , and demonstrated safety , immunogenicity , and efficacy of the vaccine in preclinical studies .


Here we report the first clinical trial of MVDP delivered by inhalation .


Sixty adult males aged @ to @ years , seropositive for measles antibody , were enrolled in this controlled Phase I clinical study .


Subjects were randomly assigned in @:@:@ ratio to receive either MVDP by Puffhaler ( ) or by Solovent devices or the licensed subcutaneous measles vaccine .


Adverse events ( AEs ) were recorded with diary cards until day @ post-vaccination and subjects were followed for @ days post-vaccination to assess potential serious long term adverse events .


Measles antibody was measured @ days before vaccination and at days @ and @ after vaccination by ELISA and a plaque reduction neutralization test .


All subjects completed the study according to protocol .


Most subjects had high levels of baseline measles antibody .


No adverse events were reported .


MVDP produced serologic responses similar to subcutaneous vaccination .


MVDP was well tolerated in all subjects .


Most subjects had high baseline measles antibody titer which limited ability to measure the serologic responses , and may have limited the adverse events following vaccination .


Additional studies in subjects without pre-existing measles antibody are needed to further elucidate the safety and immunogenicity of MVDP .


To compare the efficacy and tolerability of morning-only polyethylene glycol ( PEG ) with split-dose preparation in hospitalized patients scheduled for colonoscopy .


Morning-only colonoscopy preparation may improve efficiency by allowing patient preparation and colonoscopy to be performed on the same day .


There are limited data comparing morning-only with split-dose preparation , and more studies are needed before morning-only preparation can be routinely recommended .


A single-center , prospective , endoscopist-blinded study was conducted , in which hospitalized patients scheduled to undergo diagnostic colonoscopy were randomly assigned to receive @ L of PEG either on the morning of colonoscopy or as a split-dose ( evening-morning ) .


The primary endpoint was efficacy of bowel preparation measured by the Ottawa scale .


Secondary endpoints were patient compliance and tolerance .


A total of @ hospitalized patients scheduled for diagnostic colonoscopy were randomized .


The mean total Ottawa score was slightly superior for the morning-only arm , and the upper bound of @ % confidence interval ( CI ) for difference between arms was less than our prespecified noninferiority margin of @ ( difference = -@ ; @ % CI , -@ to @ ) .


The percentage of patients with good bowel preparation was similar for all colonic segments .


There was a trend toward more side effects among patients in the morning-only compared with the split-dose arm ( @ % vs. @ % ; P = @ ) .


Compared with morning-only preparation , more patients in the split-dose arm were willing to undergo similar preparation for future colonoscopies ( @ % vs. @ % ; P = @ ) .


Morning-only PEG is not inferior to split-dose preparation regarding bowel cleansing efficacy for colonoscopy in hospitalized patients .


However , split-dose preparation was preferred by patients because of less side effects .


Caring for a young person experiencing first-episode psychosis is challenging and can affect carers ' well-being adversely .


While some face-to-face approaches have achieved promising outcomes , they are costly and resource-intensive to provide , restricting their reach and penetration .


Guided self-help in book-form ( or bibliotherapy ) is an alternative but untested approach in these circumstances .


In this study , we aimed to evaluate carers ' beliefs about the usefulness of problem-solving guided self-help manual for primary carers of young people with first-episode psychosis .


A qualitative process evaluation nested in a randomised controlled trial , conducted across two early intervention psychosis services in Melbourne , Australia .


@ carers were randomised to problem-solving guided self-help intervention or treatment as usual .


We also undertook a qualitative process evaluation , using individual interviews , with a random sample of @ of the intervention group .


A thematic analysis of the qualitative data was undertaken , which is the subject of this paper .


Interviews were conducted between January @ and September @ .


Three themes were abstracted from the data , reflecting carers ' beliefs about the usefulness of the manual : promoting carers ' well-being , increasing carers ' understanding of and support for the young person with first-episode psychosis , and accessibility and delivery modes of the programme .


This process evaluation highlights that guided self-help is useful in informing and supporting carers of affected young people .


While there is scope for broadening the delivery modes , the approach is easy to use and accessible , and can be used as a cost-effective adjunct to standard support provided to carers , by community mental health nurses and other clinicians .


Helicobacter pylori ( H. pylori ) remains an important cause of gastric cancer and peptic ulcer disease worldwide .


Treatment of H. pylori infection is one of the effective ways to prevent gastric cancer .


However , standard triple therapy for H. pylori eradication is no longer effective in many countries , including Thailand .


This study was designed to evaluate the efficacy of adding bismuth and probiotic to standard triple therapy for H. pylori eradication .


In this prospective single center study , H. pylori infected gastritis patients were randomized to receive @ - or @-day standard triple therapy plus bismuth with probiotic or placebo .


Treatment regimen consisted of @ mg lansoprazole twice daily , @ g amoxicillin twice daily , @ g clarithromycin MR once daily and @,@ mg bismuth subsalicylate twice daily .


Probiotic bacteria composed of Bifidobacterium lactis , Lactobacillus acidophilus and Lactobacillus paracasei .


Placebo was conventional drinking yogurt without probiotic .


CYP@C@ genotyping and antibiotic susceptibility tests were also done .


H pylori eradication was defined as a negative @C-urea breath test at least @ weeks after completion of treatment .


One hundred subjects were enrolled ( @ each to @ - and @-day regimens with probiotic or placebo ) .


Antibiotic susceptibility tests showed @ % metronidazole and @ % clarithromycin resistance .


CYP@C@ genotyping revealed @ % , @ % and @ % were rapid , intermediate and poor metabolizers , respectively .


The eradication rates of @ - or @ regimens with probiotics were @ % .


Regarding adverse events , the incidence of bitter taste was significantly lower in the @ - day regimen with the probiotic group compared with @ - day regimen with placebo ( @ % vs. @ % ; p = @ ) .


The @-day standard triple therapy plus bismuth and probiotic can provide an excellent cure rate of H. pylori ( @ % ) in areas with low clarithromycin resistance such as Thailand , regardless of CYP@C@ genotype .


Adding a probiotic also reduced treatment-related adverse events .


In an ongoing prospective multicenter randomised placebo-controlled trial we study the adjuvant use of intravitreal dexamethasone in the treatment of patients with suspected bacterial endophthalmitis after phacoemulsification .


In accordance with the study protocol , a mid-inclusion interim analysis of the safety of the study drug was performed .


Patients with suspected endophthalmitis after phacoemulsification were asked to participate in this study .


A diagnostic vitreous biopsy was taken and the patients received intravitreal injections of @ micrograms dexamethasone or a placebo , plus @ mg vancomycin and @ mg gentamicin .


Injections were repeated after @ or @ days .


The safety analysis included : the number of eyes with an evisceration ; no light perception ; or a visual acuity of less than @/@ .


Treatment outcome was evaluated in terms of : the percentage of patients with a visual acuity of @/@ or more and @/@ or more .


The interim analysis included @ patients with at least @ year follow-up .


Sixty-three patients ( @ % ) were culture-positive .


Safety analysis : @ eyes were eviscerated ( @ dexamethasone , @ placebo ) ; @ eyes had no light perception ( @ dexamethasone , @ placebo ) ; and @ eyes had less than @/@ vision ( @ dexamethasone , @ placebo ) .


Treatment outcome : @ % of patients had a visual acuity of at least @/@ .


The safety analysis does not warrant premature discontinuation of the study .


So far , the overall outcome of our treatment regimen , consisting of merely a diagnostic biopsy instead of a vitrectomy and an optimized antibiotic dosing , compares favourably to published literature .


Many well-researched treatments for depression exist .


However , there is not yet enough evidence on whether these therapies , designed for the treatment of depression , are also effective for reducing suicidal ideation .


This research provides valuable information for researchers , clinicians , and suicide prevention policy makers .


Analysis was conducted on the Treatment for Depression Research Collaborative ( TDCRP ) sample , which included CBT , IPT , medication , and placebo treatment groups .