A telerehabilitation system included `` therapist end '' in a laboratory , and the `` client end '' in LTCFs .


The conventional therapy was conducted in LTCFs .


Training programs conducted for both the Tele and Conv groups showed significant effects within groups on the participant BBS as well as the total and self-care scores of BI .


No significant difference between groups could be demonstrated .


The satisfaction of participants between the Tele and the Conv groups also did not show significant difference .


This pilot study indicated that the multi-user telerehabilitation program is feasible for improving the balance and functional activity similar to conventional therapy in patients with chronic stroke living in LTCFs .


The reward value of food is partly dependent on learned associations .


It is not yet known whether replacing sugar with non-caloric sweeteners in food is affecting long-term acceptance .


To determine the effect of replacing sugar with non-caloric sweeteners in a nutrient-empty drink ( soft drink ) versus nutrient-rich drink ( yoghurt drink ) on reward value after repeated exposure .


We used a randomized crossover design whereby forty subjects ( @ men , @ women ) with a mean SD age of @ @ y and BMI of @ @ kg/m ( @ ) consumed a fixed portion of a non-caloric sweetened ( NS ) and sugar sweetened ( SS ) versions of either a soft drink or a yoghurt drink ( counterbalanced ) for breakfast which were distinguishable by means of colored labels .


Each version of a drink was offered @ times in semi-random order .


Before and after conditioning the reward value of the drinks was assessed using behavioral tasks on wanting , liking , and expected satiety .


In a subgroup ( n = @ ) fMRI was performed to assess brain reward responses to the drinks .


Outcomes of both the behavioral tasks and fMRI showed that conditioning did not affect the reward value of the NS and SS versions of the drinks significantly .


Overall , subjects preferred the yoghurt drinks to the soft drinks and the ss drinks to the NS drinks .


In addition , they expected the yoghurt drinks to be more satiating , they reduced hunger more , and delayed the first eating episode more .


Conditioning did not influence these effects .


Our study showed that repeated consumption of a non-caloric sweetened beverage , instead of a sugar sweetened version , appears not to result in changes in the reward value .


It can not be ruled out that learned associations between sensory attributes and food satiating capacity which developed preceding the conditioning period , during lifetime , affected the reward value of the drinks .


We test the hypothesis that anesthesia , measured as pain scores , induced by a novel topical anesthetic putty is non-inferior ( margin = @ ) to that provided by conventional lidocaine infiltration for the repair of lacerations .


A randomized controlled trial was conducted in the emergency department ( ED ) of a local hospital .


Participants were randomly allocated to receive either infiltration anesthesia or topical anesthetic putty as per the trial protocol .


Pain scores were recorded @ minutes after infiltration and @ minutes after topical anesthetic putty application .


Median pain scores were compared between groups .


Wound evaluation scores were conducted after @ to @ days and adverse events were monitored for both groups of participants throughout the study .


One hundred and ten participants were enrolled in the study , with @ receiving infiltration and @ receiving topical anesthetic putty .


The median difference between the pain scores of the @ groups was @ ( @ % confidence interval -@ to @ ) .


There were no substantial differences between the @ groups in terms of either the wound evaluation scores or the incidence of adverse events .


The novel topical anesthetic putty was not inferior to infiltration with lidocaine with respect to the pain experienced during suturing , and this putty is a feasible alternative to infiltration anesthesia of lacerations in the ED .


To explore the value of preoperative evaluation with three-dimensional endoanal ultrasonography ( @D-EAUS ) for anal fistula in order to provide preoperative assessment for anal fistula .


One hundred patients diagnosed with anal fistula undergoing surgery between March @ and March @ in our department were prospectively enrolled .


All the patients were randomly divided into the ultrasound group and the control group with fifty patients in each group .


The ultrasound group received @D-EAUS and the control group received routine examinations ( digital examination and probe ) to assess the position of the internal opening , the type of fistula and secondary tracks , respectively .


The concordance rate of the preoperative assessment and intraoperative exploration was evaluated between the two groups .


The accuracy of identifying internal opening was @ % for the ultrasound group and @ % for the control group with statistically significant difference ( P = @ ) .


The accuracy of identifying internal opening for simple anal fistula was similar ( @ % vs. @ % , P = @ ) .


For complex anal fistula , the accuracy was also higher in the ultrasound group ( @ % vs. @ % , P = @ ) .


The accuracy of fistula classification was @ % for the ultrasound group and @ % for the control group with significant difference ( P = @ ) .


The accuracy of identifying a second track was higher in the ultrasound group ( @ % vs. @ % , P = @ ) .


It is significantly superior for @D-EAUS to detect the internal opening , fistula classification and identification of a second track in complex anal fistulas as compared to conventional examination .


@D-EAUS should be recommended as a preoperative assessment for anal fistula , especially for complex one .


The quality of integrated diabetes care is important for reducing the burden of diabetes .


Therefore , we have evaluated the effect of a supervision program on the quality of integrated diabetes care in the Netherlands in the @-@ period .


In this cluster RCT , the supervision program was assigned to randomly selected care groups providing care to diabetes patients .


The supervision program included announcements of inspections , site visits , and sending individualized reports .


Indicators of effectiveness were derived from the structures , processes , and outcomes of care .


These indicators were collected from patients ' files , before and after the supervision program .


Hierarchical linear and logistic regression models were used to analyze data from @ patients of @ intervention and @ control care groups .


Structures and processes of care did not improve more in the intervention groups than in the control care groups .


Moreover , health outcomes did not improve more in the intervention groups than in the control care groups .


Although structures of care improved over time in the total population of intervention and control care groups , there were no changes in process of care or health outcomes .


In this cluster RCT , we could not demonstrate improvements in quality of integrated diabetes care resulting from the supervision program .


Although structures of care did improve over time , other quality-improvement initiatives are necessary to substantially strengthen integrated care for diabetes patients .


Following a major burn , skeletal muscle protein synthesis rate increases but is often insufficient to compensate for massively elevated muscle protein breakdown rates .


Given the long-term nature of the pathophysiologic response to burn injury , we hypothesized that muscle protein synthesis rate would be chronically elevated in severely burned children .


The objectives of this study were to characterize muscle protein synthesis rate of burned children over a period of @ months after injury and to identify predictors that influence this response .


A total of @ children with @ % or greater total body surface area ( TBSA ) burned were included .


Patients participated in stable isotope infusion studies at @ , @ , and approximately @ weeks after burn and at @ , @ , and @ months after injury to determine skeletal muscle protein fractional synthesis rate .


Generalized estimating equations with log link normal distribution were applied to account for clustering of patients and control for patient characteristics .


Patients ( @ @ years ) had large ( @ , @-@ % TBSA ) and deep ( @ % @ % TBSA third degree ) burns .


Muscle protein fractional synthesis rate was elevated throughout the first @ months after burn compared with established values from healthy young adults .


Muscle protein fractional synthesis rate was lower in boys , in children older than @ years , and when burns were greater than @ % TBSA .


Muscle protein synthesis is elevated for at least @ year after injury , suggesting that greater muscle protein turnover is a component of the long-term pathophysiologic response to burn trauma .


Muscle protein synthesis is highly affected by sex , age , and burn size in severely burned children .


These findings may explain the divergence in net protein balance and lean body mass in different populations of burn patients .


Prognostic study , level III .


In this study , we evaluated long-term survival in patients treated with and without mechanical bowel preparation ( MBP ) before colorectal surgery for cancer .


Long-term outcome of patients of @ main participating hospitals in a prior multicenter randomized trial comparing clinical outcome of MBP versus no MBP was reviewed .


Primary endpoint was cancer-related mortality and secondary endpoint was all-cause mortality .


A total of @ patients underwent potentially curative surgery for colorectal cancer .


One hundred seventy-seven ( @ % ) patients were treated with MBP and @ ( @ % ) were not before surgery .


Median follow-up was @ years ( mean @ , range @ to @ ) .


There was no significant difference in both cancer-related mortality and all-cause mortality in patients treated with MBP and without MBP ( P = @ and P = @ , respectively ) .


Multivariate analysis , taking account of age , sex , AJCC cancer stage , and ASA classification , also showed no survival difference .


Our results indicate that MBP does not seem to influence long-term survival in patients surgically treated for colorectal cancer .


Applying appropriate positive end-expiratory pressure ( PEEP ) to corresponding intra-abdominal pressure ( IAP ) can improve gas exchange during capnoperitoneum without any hemodynamic effects .


A total of @ patients were randomly allocated to group @PEEP ( n = @ ) , group @PEEP ( n = @ ) , and group @PEEP ( n = @ ) according to the level of PEEP , in whom capnoperitoneum was created with IAP of @ , @ , and @ mm Hg , respectively .


Hemodynamic and respiratory parameters were recorded up to @ minutes after capnoperitoneum .


In @PEEP group , mean end-tidal carbon dioxide demonstrated significant rise @ minutes after capnoperitoneum and plateaued at about @ minutes but remained at high level for up to @ minutes when compared with the @PEEP and @PEEP groups ( P < @ ) .


Correspondingly , the mean PaCO@ ( @ mm Hg ) for the @PEEP group was higher at @ minutes when compared with @PEEP ( @ mm Hg ) and @PEEP ( @ mm Hg ) groups .


The oxygenation was better preserved in @PEEP and @PEEP groups with significantly higher PaO@/Fio@ ratio .


Heart rate , mean arterial pressure , and cardiac output remained stable throughout the study in all the @ groups .


Application of appropriate PEEP corresponding to the IAP helped maintain CO@ elimination and improved oxygenation without any hemodynamic disturbance in patients undergoing laparoscopic cholecystectomy .


Isoflavones are present in soy foods and soy-based supplements .


Despite low plasma isoflavone concentrations in the general Western population , concentrations in supplement users exceed those suggested to be beneficial for health in Asian populations , raising concerns for adverse effects .


To aid risk assessment , quantification of the relation between isoflavone intake and plasma concentrations is essential .


Plasma samples were collected from postmenopausal women in three placebo-controlled crossover studies with @-week periods for supplements ( two studies , ~ @mg isoflavones/day , n = @ ) or @-week periods for soy foods ( one study , ~ @mg isoflavones/day , n = @ ) .


Plasma isoflavone concentrations ( daidzein , equol , genistein and glycitein ) were quantified using high-performance liquid chromatography and electrochemical detection .


The association between plasma concentrations and isoflavone intake , equol producer status , intake-producer interaction and background dietary intake was assessed based on the assumption of a log-linear relation .


Median plasma total isoflavone concentrations after the soy food and supplement interventions were respectively @ and @ mol/l for equol producers and @ and @ mol/l for non-producers .


Regression analysis showed that doubling isoflavone intake increased plasma concentrations by @-@ % ( s.e. @-@ % , R ( @ ) > @ ) for daidzein , genistein , equol ( only for producers ) and total isoflavones ; for glycitein the association was weaker ( @ % , R ( @ ) = @ ) .


Adjustments for energy , carbohydrate and fat intake did not affect these estimates .


Inter-individual variation , estimated based on repeated measures in one of the studies , was @-@ % .


Although the relation between isoflavone intake and plasma concentrations was adequately quantified , the use of isoflavone intake data for risk assessment needs caution due to large inter-individual variation in plasma concentrations .


The simultaneous presence of cancer and other medical conditions ( comorbidity ) is frequent .


Cigarette smoking is the major risk factor for as well head and neck cancer ( HNC ) and lung cancer ( LC ) as chronic obstructive pulmonary disease ( COPD ) .


COPD is the most common comorbidity in LC patients , and presence of COPD worsens the prognosis of HNC and LC .


COPD is under-diagnosed and under-treated in the Danish population .


The aims of this study were to determine the prevalence of COPD in a HNC and LC population , and to determine the need and feasibility of a randomized controlled phase II trial comparing usual care with optimized medical treatment of COPD in cancer patients .


All patients with HNC or LC referred for oncologic treatment in a university hospital during a @-month period were invited to attend a pulmonary clinic for evaluation of lung function .


Patients who were found to have concomitant COPD were randomized to intervention or usual care .


Primary endpoints were prevalence of COPD among the referred patients with either LC or HNC , and further whether the patients that were diagnosed with COPD already received treatment in accordance with Danish COPD guidelines .


Secondary outcome was feasibility , i.e. the proportion of eligible patients that accepted follow-up in the pulmonary clinic for @ weeks in addition to oncological treatment .


The design of the randomized trail is described in detail .


In total @ patients of whom @ % had LC and @ % HNC have been screened during the first seven months of this ongoing trial .


Sixty-eight percent of LC patients and @ % of HNC patients had COPD .


All but one of @ eligible patients accepted randomization .


Nearly one third ( @ % ) of the LC and HNC patients with COPD were diagnosed prior to study entry , and of these , only @ % were receiving correct treatment according to current guidelines .


For patients with LC , and to a lesser extend HNC , there is a need for improved diagnosis and treatment of concomitant COPD .


Furthermore , patients found it acceptable to be scheduled for a @-week follow-up in a pulmonary clinic along with their oncological treatment .


Existing eye-tracking literature has shown that both adults and children with autism spectrum disorders ( ASD ) show fewer and slower fixations on faces .


Despite this reduced saliency and processing of other faces , recognition of their own face is reported to be more `` typical '' in nature .


This study uses eye-tracking to explore the typicality of gaze patterns when children with ASD attend their own faces compared to other familiar and unfamiliar faces .


Eye-tracking methodology was used to explore fixation duration and time taken to fixate on the Eye and Mouth regions of familiar , unfamiliar and Self Faces .


Twenty-one children with ASD ( @-@ years ) were compared to typically developing matched groups .


There were no significant differences between children with ASD and typically matched groups for fixation patterns to the Eye and Mouth areas of all face types ( familiar , unfamiliar and self ) .


Correlational analyses showed that attention to the Eye area of unfamiliar and Self Faces was related to socio-communicative ability in children with ASD .


Levels of socio-communicative ability in children with ASD were related to gaze patterns on unfamiliar and Self Faces , but not familiar faces .


This lack of relationship between ability and attention to familiar faces may indicate that children across the autism spectrum are able to fixate these faces in a similar way .


The implications for these findings are discussed .


To determine if increasing the hormone dose or eliminating the hormone-free interval improves key pharmacokinetic ( PK ) alterations caused by obesity during oral contraceptive ( OC ) use .


Obese -LSB- body mass index ( BMI ) @ kg/m ( @ ) -RSB- , ovulatory , otherwise healthy , women received an OC containing @ mcg ethinyl estradiol ( EE ) / @ mcg levonorgestrel ( LNG ) dosed cyclically ( @ days active pills with @-day placebo week ) for two cycles and then were randomized for two additional cycles to the following : continuous cycling ( CC , a dose neutral arm using the same OC with no hormone-free interval ) or increased dose ( ID , a dose escalation arm using an OC containing @ mcg EE/@ mcg LNG cyclically ) .


During Cycles @ , @ and @ , outpatient visits were performed to assess maximum serum concentration ( Cmax ) , area under the curve ( AUC@ - ) and time to steady state as well as pharmacodynamics .


These key PK parameters were calculated and compared within groups between baseline and treatment cycles .


A total of @ women enrolled and completed the study ( CC group , n = @ ; ID group , n = @ ) .


Demographics were similar between groups -LSB- mean BMI : CC , @ kg/m ( @ ) ( S.D. @ ) ; ID , @ kg/m ( @ ) ( S.D. @ ) -RSB- .


At baseline , the key LNG PK parameters were no different between groups ; average time to reach steady state was @ days in both groups ; Cmax were CC : @ ng/mL and ID : @ ng/mL ; and AUC@ - were CC : @ h ng/mL and ID : @ h ng/mL .


Following randomization , the CC group maintained steady-state serum levels whereas the ID group had a significantly higher Cmax ( p < @ ) but again required @ days to achieve steady state .


However , AUC was not significantly different between CC ( @ h ng/mL ) and ID ( @ h ng/mL ) .


Forty-five percent ( @/@ ) of the study population had evidence of an active follicle-like structure prior to randomization and afterwards this decreased to @ % ( @/@ ) .


Both increasing the OC dose and continuous dosing appear to counteract the impact of obesity on key OC PK parameters .


Obesity adversely affects the pharmacokinetics of very low dose OC pills .


Although the impact of these changes on OC efficacy is still under debate , PK parameters can be normalized in obese users by continuous dosing or increasing to a low-dose pill .


Postural balance and potentially fall risk increases among older adults living with neurological diseases , especially Parkinson 's disease ( PD ) .


Since conventional therapies such as levodopa or deep brain stimulation may fail to alleviate or may even worsen balance , interest is growing in evaluating alternative PD therapies .


The purpose of the current study was to assess improvement in postural balance in PD patients following electroacupuncture ( EA ) as an alternative therapy .


@ aging adults ( @ @ years ) with idiopathic PD and @ healthy age-matched participants ( @ @ years ) were recruited .


The PD participants were randomly assigned ( at a ratio of @:@ ) to an intervention ( n = @ ) or to a control group ( n = @ ) .


The intervention group received a @-min EA treatment on a weekly basis for @ weeks , while the control group received a sham treatment .


Outcomes were assessed at baseline and after the final therapy .


Measurements included balance assessment , specifically the ratio of medial-lateral ( ML ) center-of-gravity ( COG ) sway to anterior-posterior ( AP ) sway ( COGML/AP ) and ankle/hip sway during eyes-open , eyes-closed , and eyes-open dual-task trials , the Unified Parkinson 's Disease Rating Scale ( UPDRS ) , as well as quality of life , concerns for fall , and pain questionnaires .


No difference was observed for the assessed parameters between the intervention and the control group at baseline .


After treatment , an improvement in balance performance was observed in the intervention group .


Compared with the healthy population , PD patients prior to treatment had larger COGML/AP sway with more dependency on upper-body movements for maintaining balance .


Following EA therapy , COGML/AP sway was reduced by @ % and ankle/hip sway increased by @ % in the different conditions ( p = @ for the dual-task condition ) .


The clinical rating revealed an overall improvement ( p < @ ) in mentation , behavior , and mood ( UPDRS part I , @ % ) , activities of daily living ( UPDRS part II , @ % ) , and motor examination ( UPDRS part III , @ % ) .


There was a significant reduction ( p < @ ) in the specific items regarding UPDRS fall status ( @ % ) and rigidity ( @ % ) .


Changes were small and nonsignificant in the controls ( p > @ ) .


This pilot study demonstrates improvement in rigidity and balance following EA .


These preliminary results suggest EA could be a promising alternative treatment for balance disturbance in PD .


Smoking reduction remains a pivotal issue in public health policy , but quit rates obtained with traditional quit-smoking therapies remain disappointingly low .


Tobacco Harm Reduction ( THR ) , aiming at less harmful ways of consuming nicotine , may provide a more effective alternative .


One promising candidate for THR are electronic cigarettes ( e-cigs ) .


The aim of this study was to investigate the efficacy of second-generation e-cigs both in terms of acute craving-reduction in the lab and in terms of smoking reduction and experienced benefits/complaints in an eight-month Randomized Controlled Trial ( RCT ) .


RCT with three arms .


Participants ( N = @ ) unwilling to quit smoking were randomized into two e-cig groups and one control group .


During three lab sessions ( over two months ) participants , who had been abstinent for four hours , vaped/smoked for five minutes , after which we monitored the effect on craving and withdrawal symptoms .


eCO and saliva cotinine levels were also measured .


In between lab sessions , participants in the e-cig groups could use e-cigs or smoke ad libitum , whereas the control group could only smoke .


After the lab sessions , the control group also received an e-cig .


The RCT included several questionnaires , which repeatedly monitored the effect of ad libitum e-cig use on the use of tobacco cigarettes and the experienced benefits/complaints up to six months after the last lab session .


From the first lab session on , e-cig use after four hours of abstinence resulted in a reduction in cigarette craving which was of the same magnitude as when a cigarette was smoked , while eCO was unaffected .


After two months , we observed that @ % of the e-cig groups had stopped smoking tobacco cigarettes , versus @ % of the control group .


After five months , the e-cig groups demonstrated a total quit-rate of @ % , whereas the control group showed a quit rate of @ % three months after initiating e-cig use .


At the end of the eight-month study , @ % of the e-cig groups and @ % of the control group were totally abstinent from smoking , while an overall reduction of @ % in the number of cigarettes smoked per day was observed ( compared to intake ) .


eCO levels decreased , whereas cotinine levels were the same in all groups at each moment of measurement .


Reported benefits far outweighed the reported complaints .


In a series of controlled lab sessions with e-cig nave tobacco smokers , second generation e-cigs were shown to be immediately and highly effective in reducing abstinence induced cigarette craving and withdrawal symptoms , while not resulting in increases in eCO .


Remarkable ( > @ pc ) eight-month reductions in , or complete abstinence from tobacco smoking was achieved with the e-cig in almost half ( @ % ) of the participants .


Improving nutrition and physical activity behaviors associated with childhood obesity are significant national public health goals .


Energy Balance for Kids with Play ( EB@K with Play ) , developed through a partnership between the Academy of Nutrition and Dietetics Foundation and Playworks , is a multi-component school-based intervention designed to address youth 's nutrition and physical activity behaviors .


This article describes the EB@K with Play intervention and evaluation study and presents the baseline data .


The evaluation is a @-year cluster-randomized design targeting third - to fifth-grade students enrolled in a low-income , urban school district in northern California .


Six schools were recruited to participate .


Four were randomized to the intervention group and two into a control group .


Baseline student-level data pertaining to nutrition , physical activity , fitness , and BMI were collected in the fall of @ .


The EB@K with Play program , which includes direct-to-student nutrition and physical activity interventions , a school wellness component , and parent/community partner outreach components , began immediately after baseline data collection .


An ethnically diverse sample of students ( n = @ ) was recruited to participate in the study .


Baseline data showed a higher percent of eligibility for free and reduced-price school lunch and higher rates of obesity/overweight than the California state averages .


Fitness levels and levels of moderate-to-vigorous physical activity were comparable to state averages .


End-point data will be collected after @ years of the intervention .


The findings from this study should help guide future efforts to design effective intervention programs to support the prevention of pediatric obesity .


A topical fixed-dose clindamycin phosphate @ % and benzoyl peroxide @ % combination gel ( CLNP/BPO @ % ) is known to be effective and safe in white people with acne .


To evaluate the efficacy and safety of CLNP/BPO @ % topically applied once or twice daily vs. CLNP twice daily in Japanese patients with acne .


Eight hundred patients were randomized to receive CLNP/BPO @ % once daily , CLNP/BPO @ % twice daily or CLNP twice daily for @weeks .


Primary endpoints were absolute change in number of total lesions ( TLs ) from baseline to week @ to demonstrate the superiority of CLNP/BPO @ % twice daily and noninferiority of CLNP/BPO @ % once daily vs. CLNP twice daily .


Secondary endpoints were absolute and percentage changes in TLs , inflammatory lesions ( ILs ) , noninflammatory lesions ( non-ILs ) and Investigator 's Static Global Assessment ( ISGA ) score .


Safety assessments included adverse events ( AEs ) , laboratory tests , vital signs and local skin tolerability .


Change in TL counts from baseline to week @ for CLNP/BPO @ % twice daily was superior to CLNP twice daily ( difference -@ ; P < @ ) ; CLNP/BPO @ % once daily was not inferior to CLNP twice daily ( difference -@ ; P < @ ) .


Absolute and percentage reductions in TL , IL and non-IL counts and ISGA score were greater for CLNP/BPO @ % once or twice daily than for CLNP twice daily with significant differences seen from early on .


Most AEs were mild or moderate .


The incidence of adverse drug reactions was higher for CLNP/BPO @ % once ( @ % ) or twice ( @ % ) daily than for CLNP twice daily ( @ % ) .


Compared with CLNP twice daily , CLNP/BPO @ % once daily was more effective and CLNP/BPO @ % twice daily at least as effective , with an early onset of action and an acceptable safety and tolerability profile in Japanese patients .


No effective pharmaceutical agents have yet been identified to treat acute kidney injury after cardiac surgery .


To determine whether fenoldopam reduces the need for renal replacement therapy in critically ill cardiac surgery patients with acute kidney injury .


Multicenter , randomized , double-blind , placebo-controlled , parallel-group study from March @ to April @ in @ cardiovascular intensive care units in Italy .


We randomly assigned @ patients admitted to intensive care units after cardiac surgery with early acute kidney injury ( @ % increase of serum creatinine level from baseline or oliguria for @ hours ) to receive fenoldopam ( @ patients ) or placebo ( @ patients ) .


We used a computer-generated permuted block randomization sequence for treatment allocation .


All patients completed their follow-up @ days after surgery , and data were analyzed according to the intention-to-treat principle .


Continuous infusion of fenoldopam or placebo for up to @ days with a starting dose of @ g/kg/min ( range , @-@ @ g/kg/min ) .


The primary end point was the rate of renal replacement therapy .


Secondary end points included mortality ( intensive care unit and @-day mortality ) and the rate of hypotension during study drug infusion .


The study was stopped for futility as recommended by the safety committee after a planned interim analysis .


Sixty-nine of @ patients ( @ % ) allocated to the fenoldopam group and @ of @ patients ( @ % ) allocated to the placebo group received renal replacement therapy ( P = @ ) .


Mortality at @ days was @ of @ ( @ % ) in the fenoldopam group and @ of @ ( @ % ) in the placebo group ( P = @ ) .


Hypotension occurred in @ ( @ % ) patients in the fenoldopam group and in @ ( @ % ) patients in the placebo group ( P = @ ) .


Among patients with acute kidney injury after cardiac surgery , fenoldopam infusion , compared with placebo , did not reduce the need for renal replacement therapy or risk of @-day mortality but was associated with an increased rate of hypotension .


Osteoarthritis ( OA ) is a common problem in older women that is associated with pain and disabilities .


Although yoga is recommended as an exercise intervention to manage arthritis , there is limited evidence documenting its effectiveness , with little known about its long term benefits .


This study 's aims were to assess the feasibility and potential efficacy of a Hatha yoga exercise program in managing OA-related symptoms in older women with knee OA .


Eligible participants ( N = @ ; mean age @ years ) were randomly assigned to @-week yoga program involving group and home-based sessions or wait-list control .


The yoga intervention program was developed by a group of yoga experts ( N = @ ) .


The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) total score that measures knee OA pain , stiffness , and function at @ weeks .


The secondary outcomes , physical function of the lower extremities , body mass index ( BMI ) , quality of sleep ( QOS ) , and quality of life ( QOL ) , were measured using weight , height , the short physical performance battery ( SPPB ) , the Pittsburgh Sleep Quality Index ( PSQI ) , the Cantril Self-Anchoring Ladder , and the SF@v@ Health Survey .


Data were collected at baseline , @ weeks and @ weeks , and @ weeks .


The recruitment target was met , with study retention at @ % .


Based on ANCOVAs , participants in the treatment group exhibited significantly greater improvement in WOMAC pain ( adjusted means -LSB- SE -RSB- ) ( @ -LSB- @ -RSB- , @ -LSB- @ -RSB- ; p = @ ) , stiffness ( @ -LSB- @ -RSB- , @ -LSB- @ -RSB- ; p = @ ) and SPPB ( repeated chair stands ) ( @ -LSB- @ -RSB- , @ -LSB- @ -RSB- ; p = @ ) at @ weeks .


Significant treatment and time effects were seen in WOMAC pain ( @ -LSB- @ -RSB- , @ -LSB- @ -RSB- ; p = @ ) , function ( @ -LSB- @ -RSB- , @ -LSB- @ -RSB- ; p = @ ) and total scores ( @ -LSB- @ -RSB- , @ -LSB- @ -RSB- ; p = @ ) from @ to @ weeks .


Sleep disturbance was improved but the PSQI total score declined significantly at @ weeks .


Changes in BMI and QOL were not significant .


No yoga related adverse events were observed .


A weekly yoga program with home practice is feasible , acceptable , and safe for older women with knee OA , and shows therapeutic benefits .


To select suitable chemotherapy for cervical cancer patients by ATP-tumor chemosensitivity assay .


Seventy-two hospitalized patients with cervical cancer between July @ and October @ were enrolled .


The patients were randomly divided into a trial group ( n = @ ) and a control group ( n = @ ) .


ATP-TCA was used to detect the sensitivity of @ samples of cervical cancer in the trial group to @ combined chemotherapy regimens .


The chemotherapy regimen in the trial group was confirmed by the results of susceptibility testing and that in the control group was confirmed by clinical experience .


One-year recurrence rate and @ - year survival rate of two groups were compared after @ year follow-up .


ATP-TCA was measured in @ of the @ patients in the trial group .


The sensitive patients for paclitaxel + carboplatin , paclitaxel + oxaliplatin , bleomycin + ifosfamide + cisplatin , bleomycin + vincristine + cisplatin , fluorouracil + cisplatin , and gemcitabine + cisplatin were @ , @ , @ , @ , @ , and @ , respectively .


There was no significant difference in the @-year recurrence between the two groups ( P > @ ) , while the @-year survivors in the trial group were more than those in the control group ( P < @ ) .


ATP-TCA method is good for patients with cervical cancer because it is sensitive , effective , and individualized .


Exercise is a potential treatment for depression .


However , few studies have evaluated the role of adjunct exercise in the treatment of severely major depressed inpatients .


The goal of this study was to evaluate the effects of add-on exercise on the usual treatment of severely depressed inpatients .


Fifty participants were randomized to an exercise ( exercise + usual treatment ) or a control ( usual treatment ) group .


Twenty-five patients were randomly allocated to each group .


The participants in the exercise group performed three sessions per week throughout the hospitalization period , with a goal dose of @ kcal/kg/week plus the usual pharmacological treatment .


Depressive symptoms and the Quality of Life ( QoL ) of the participants were assessed at the baseline , the second week , and discharge .


A significant group time interaction was found for depressive symptoms and the physical and psychological domains of QoL .


Differences between groups occurred at the second week and discharge with respect to depressive symptoms and the physical and psychological domains of QoL .


There was no difference in the remission rate at discharge ( @ % and @ % for the exercise and control group , respectively ) .


An NNT of @ was found .


No significant baseline characteristics predict remission at discharge .


Add-on exercise is an efficacious treatment for severely depressed inpatients , improving their depressive symptoms and QoL .


Initial acceptance of exercise remains a challenge .


The IMProved Reduction of Outcomes : Vytorin Efficacy International Trial ( IMPROVE-IT ) is evaluating the potential benefit for reduction in major cardiovascular ( CV ) events from the addition of ezetimibe versus placebo to @ mg/d of simvastatin therapy in patients who present with acute coronary syndromes and have low-density lipoprotein cholesterol ( LDL-C ) @ mg/dl .


Randomized double blind clinical trial in patients with acute coronary syndrome and low cholesterol level .


The simvastatin monotherapy arms LDL-C target was < @ mg/dl , the comparison arm was simvastatin + ezetimibe .


Ezetimibe was assumed to further lower LDL-C by @ mg/dl and produce an estimated ~ @ % to @ % treatment effect .


The primary composite end point was CV death , nonfatal myocardial infarction ( MI ) , nonfatal stroke , rehospitalization for unstable angina ( UA ) , and coronary revascularization ( @ days postrandomization ) .


The targeted number of events was @,@ .


@,@ patients were enroled with either ST segment elevation MI ( STEMI , n = @,@ ) or UA/non-ST segment elevation MI ( UA/NSTEMI , n = @,@ ) from October @ to July @ .


Primary endpoint occured in @ patients ( @ % ) treated with simvastatin in monotherapy and in @ patients ( @ % ) ( p = @ ) treated with combination .


Compared to patients with coronary heart disease given the drug simvastatin plus a placebo , those given both simvastatin and the non-statin drug , ezetimibe , had a @ % lower combined risk of subsequent heart attack , stroke , cardiovascular death , rehospitalization for unstable angina and procedures to restore blood flow to the heart .


Heart attacks alone were reduced by @ % , and non-fatal stroke by @ % .


Deaths from cardiovascular disease were statistically the same in both groups .


Patients were followed an average of approximately six years , and some as long as @ years .


Approximately @ patients out of every @ patients treated for @ years avoided a heart attack or stroke -LSB- Number Needed to Treat ( NNT ) = @/@ years -RSB- .


The study has shown a claer benefit from combination treatment with simvastatin and ezetimibe in patients with acute coronary syndrome and low LDL-C .


We investigated the feasibility and acceptance of electronic monitoring of symptoms and syndromes in oncological outpatient clinics using a PALM ( handheld computer ) .


The assessment of a combination of symptoms and clinical benefit parameters grouped in four pairs was tested in a pilot phase in advanced cancer patients .


Based on these experiences , the software E-MOSAIC was developed , consisting of patient-reported symptoms and nutritional intake and objective assessments ( weight , weight loss , performance status and medication for pain , fatigue , and cachexia ) .


E-MOSAIC was then tested in four Swiss oncology centers .


In order to compare the methods , patients completed the E-MOSAIC as a paper and a PALM version .


Preferences of version and completion times were collected .


Assessments were compared using Wilcoxon signed-rank tests , and the test-retest reliability was evaluated .


The pilot phase was completed by @ patients .


Most patients and physicians perceived the assessment as useful .


Sixty-two patients participated in the feasibility study .


Twelve patients reported problems ( understanding , optical , tactile ) , and five patients could not complete the assessment .


The median time to complete the PALM-based assessment was @min .


Forty-nine percent of patients preferred the PALM , @ % preferred a paper version , and @ % of patients had no preference .


Paper vs. PALM revealed no significant differences in symptoms , but in nutritional intake ( p = @ ) .


Test-retest ( @h , n = @ ) reliability was satisfactory ( r = @-@ ) .


Electronic symptom and clinical benefit monitoring is feasible in oncology outpatient clinics and perceived as useful by patients , oncology nurses , and oncologists .


E-MOSAIC is tested in a prospective randomized trial .


To perform a comparative evaluation of the efficacy and acceptability of Rose-K and Soper contact lenses in Keratoconus .


Dr. Rajendra Prasad Center for Ophthalmic Sciences , All India Institute of Medical Sciences , New Delhi .


A randomized comparative clinical trial was performed in keratoconic eyes fitted with Rose-K ( Rose-K group ) and Soper ( Soper group ) contact lenses .


Patients data were evaluated for best spectacle corrected visual acuity , best contact lens corrected visual acuity ( BCLCVA ) , corneal topography , glare acuity , contrast sensitivity , tear function tests and specular microscopy .


Patients were also asked to complete a self-reported comfort questionnaire at each visit .


Sixty eyes were randomized to the Rose-K and Soper groups .


The two groups were comparable in all the baseline parameters .


There was a statistically significant improvement in BCLCVA in both groups at @ months ( P < @ , both groups ) .


The difference between in BCLCVA in both groups was not statistically significant .


In both groups , there was a significant improvement in the comfort score at @ months compared to baseline ( P < @ , both group ) .


The Rose-K group had statistically significantly better scores at @ and @ months compared with the Soper group ( P = @ and P < @ respectively ) .


Both groups were associated with a significant ( P < @ ) , but comparable improvement in glare acuity at @ months .


There was a significant improvement in contrast sensitivity at @ months in both groups ( P < @ ) ; the Rose-K group was significantly better than the Soper group at @ and @ months ( P = @ and @ respectively ) .


The mean number of trial lenses required for fitting Rose-K lens ( @ @ ) was significantly lower than the Soper lens ( @ @ ; P < @ ) .


Both the contact lens designs provide an equal improvement in visual acuity in patients with Keratoconus .


However , Rose-K contact lens provides greater comfort , better quality of vision and requires less chair time compared with the Soper lens and hence may possibly have a greater acceptability .


To observe the effect of electroacupuncture ( EA ) combined with ultraviolet therapy on herpes zoster at the acute stage and the impacts on serum interleukin @ ( IL-@ ) , interleukin @ ( IL-@ ) and interleukin @ ( IL-@ ) in the patients .


Thirty-four patients of herpes zoster were randomized into a medicine group and a combined therapy group , @ cases in each one .


In the medicine group , the intravenous drops with acyclovir injection , muscular injection with cobamamide and the topical with acyclovir ointment were applied .


Additionally , TDP was radiated locally .


In the combined therapy group , on the basis of the treatment as the medicine group , EA and ultraviolet therapy were supplemented .


The duration of treatment was @ days in the two groups .


Before and after treatment , blister relief , incrustation time and the visible analogue scale ( VAS ) were recorded in the two groups .


The clinical efficacy was assessed in the two groups and the levels of serum IL-@ , IL-@ and IL-@ were determined in the two groups .


In the combined therapy group , the time of blister relief and incrustation was earlier apparently than that in the medicine group ( both P < @ ) .


VAS score after treatment were reduced as compared with that before treatment in the two groups ( both P < @ ) , and the reducing amplitude in the combined therapy group was larger than that in the medicine group ( P < @ ) .


The total effective rate was @ % ( @/@ ) in the combined therapy group , higher than @ % ( @/@ ) in the medicine group ( P < @ ) .


After treatment , IL-@ levels were increased as compared with those before treatment in the two groups ( both P < @ ) , the levels of IL-@ and IL-@ were reduced obviously as compared with those before treatment in the two groups ( all P < @ ) .


After treatment , the levels of IL-@ , IL-@ were reduced much more apparently in the combined therapy group as compared with those in the medicine group ( both P < @ ) .


EA combined with ultraviolet irradiation more rapidly and effectively relief the symptoms of herpes zoster , significantly relief pain , shorten the duration of sickness , improve the body immunity and reduce nerve injury .


Imatinib mesylate ( IM ) is a selective tyrosine kinase inhibitor for the treatment of chronic myeloid leukemia and gastrointestinal stromal tumors .


A new once-daily @-mg film-coated tablet of imatinib has been developed by a pharmaceutical company in Korea .


The present study was designed to assess and compare the PK parameters , bioavailability , and bioequivalence of the new imatinib @-mg formulation ( test ) versus the conventional @-mg formulation ( reference ) administered as a single @-mg dose in healthy adult male volunteers .


This randomized , open-label , single-dose , two-way crossover study was conducted in healthy Korean male volunteers .


Eligible subjects were randomly assigned in a @ : @ ratio to receive @ mg of the test ( one @-mg tablet ) or reference ( four @-mg tablets ) formulation , followed by a @-week washout period and administration of the alternate formulation .


Serial blood samples were collected at @ ( predose ) , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , @ , and @ hours after administration .


Plasma imatinib concentrations were determined using liquid chromatography coupled with tandem mass spectrometry .


The formulations were to be considered bioequivalent if the @ % confidence intervals ( CIs ) of the adjusted geometric mean ratios for Cmax , AUC ( @-t ) , and AUC ( @ - ) were within the predetermined range of @ - @ .


In total , @ subjects completed the study .


No serious adverse event was reported during the study .


The @ % CIs of the adjusted geometric mean ratios of the test formulation to the reference formulation for C ( max ) , AUC ( @-t ) and AUC ( @ - ) of imatinib were all within the bioequivalence criteria range of @ - @ .


The test formulation of imatinib met the Korean regulatory requirements for bioequivalence .


Both imatinib formulations were well-tolerated in all subjects .


To assess the safety and effectiveness of the Hydrus Microstent ( Ivantis , Inc , Irvine , CA ) with concurrent cataract surgery ( CS ) for reducing intraocular pressure ( IOP ) in open-angle glaucoma ( OAG ) .


Prospective , multicenter , randomized , single-masked , controlled clinical trial .


One hundred eyes from @ patients @ to @ years of age with OAG and cataract with IOP of @ mmHg or less with @ or fewer hypotensive medications and a washed-out diurnal IOP ( DIOP ) of @ to @ mmHg .


On the day of surgery , patients were randomized @:@ to undergo CS with the microstent or CS alone .


Postoperative follow-up was at @ day , @ week , and @ , @ , @ , @ , @ , and @ months .


Washout of hypotensive medications was repeated at @ and @ months .


Response to treatment was defined as a @ % or more decrease in washed out DIOP at @ and @ months of follow-up compared with baseline .


Mean DIOP at @ and @ months , the proportion of subjects requiring medications at follow-up , and the mean number of medications were analyzed .


Safety measures included change in visual acuity , slit-lamp observations , and adverse events .


The proportion of patients with a @ % reduction in washed out DIOP was significantly higher in the Hydrus plus CS group at @ months compared with the CS group ( @ % vs. @ % ; P = @ ) .


Washed out mean DIOP in the Hydrus plus CS group was significantly lower at @ months compared with the CS group ( @ mmHg vs. @ mmHg ; P = @ ) , and the proportion of patients using no hypotensive medications was significantly higher at @ months in the Hydrus plus CS group ( @ % vs. @ % ; P = @ ) .


There were no differences in follow-up visual acuity between groups .


The only notable device-related adverse event was focal peripheral anterior synechiae ( @-@ mm in length ) .


Otherwise , adverse event frequency was similar in the @ groups .


Intraocular pressure was clinically and statistically significantly lower at @ years in the Hydrus plus CS group compared with the CS alone group , with no differences in safety .


To determine whether bronchoalveolar lavage ( BAL ) - directed therapy for infants and young children with cystic fibrosis ( CF ) , rather than standard therapy , was justified on the grounds of a decrease in average costs and whether the use of BAL reduced treatment costs associated with hospital admissions .


Costs were assessed in a randomized controlled trial conducted in Australia and New Zealand on infants diagnosed with CF after newborn screening and assigned to receive either BAL-directed or standard therapy until they reached @ years of age .


A health care funder perspective was adopted .


Resource use measurement was based on standardized data collection forms administered for patients across all sites .


Unit costs were obtained primarily from government schedules .


Mean costs per child during the study period were Australian dollars ( AUD ) @ in BAL-directed therapy group and AUD@ in standard therapy group ( mean difference AUD@ , @ % CI AUD-@ to @ , P = @ ) .


Mean hospital costs per child during the study period were AUD@ in the BAL-directed therapy group and AUD@ in the standard therapy group ( mean difference AUD-@ ; @ % CI AUD-@ to @ , P = @ ) .


BAL-directed therapy did not result in either lower mean hospital admission costs or mean costs overall compared with managing patients with CF by a standard protocol based upon clinical features and oropharyngeal culture results alone .


Following on our previous findings that BAL-directed treatment offers no clinical advantage over standard therapy at age @ years , flexible bronchoscopy with BAL can not be recommended for the routine management of preschool children with CF on the basis of overall cost savings .


Recent research has investigated the use of ultrasound ( US ) for confirming endotracheal tube ( ETT ) placement with varying techniques , accuracies , and challenges .


Our objective was to evaluate the accuracy of a novel , simplified , four-step ( @S ) technique .


We conducted a blinded , randomized trial of the @S technique utilizing an adult human cadaver model .


ETT placement was randomized to tracheal or esophageal location .


Three US experts and @ emergency medicine residents ( EMR ) performed a total of @ scans .


The primary outcome was the overall sensitivity and specificity of both experts and EMRs to detect location of ETT placement .


Secondary outcomes included a priori subgroup comparison of experts and EMRs for thin and obese cadavers , time to detection , and level of operator confidence .


Experts had a sensitivity of @ % ( @ % CI = @ % to @ % ) and specificity of @ % ( @ % CI = @ % to @ % ) on thin , and a sensitivity of @ % ( @ % CI = @ % to @ % ) and specificity of @ % ( @ % CI = @ % to @ % ) on obese cadavers .


EMRs had a sensitivity of @ % ( @ % CI = @ % to @ % ) and of specificity @ % ( @ % CI = @ % to @ % ) on thin , and a sensitivity of @ % ( @ % CI = @ % to @ % ) specificity of @ % ( @ % CI = @ % to @ % ) on obese cadavers .


The overall mean time to detection was @ seconds ( @ % CI = @ seconds to @ seconds , range : @ to @ seconds ) for US experts and @ seconds ( @ % CI = @ seconds to @ seconds ; range : @ to @ seconds ) for EMRs .


There was a statistically significant decrease in the specificity of this technique on obese cadavers when comparing the EMRs and experts , as well as an increased overall time to detection among the EMRs .


The simplified @S technique was accurate and rapid for US experts .


Among novices , the @S technique was accurate in thin , but appears less accurate in obese cadavers .


Further studies will determine optimal teaching time and accuracy in emergency department patients .


Uncertainty remains about the efficacy of folic acid therapy for the primary prevention of stroke because of limited and inconsistent data .


To test the primary hypothesis that therapy with enalapril and folic acid is more effective in reducing first stroke than enalapril alone among Chinese adults with hypertension .


The China Stroke Primary Prevention Trial , a randomized , double-blind clinical trial conducted from May @ , @ , to August @ , @ , in @ communities in Jiangsu and Anhui provinces in China .


A total of @,@ adults with hypertension without history of stroke or myocardial infarction ( MI ) participated in the study .


Eligible participants , stratified by MTHFR C@T genotypes ( CC , CT , and TT ) , were randomly assigned to receive double-blind daily treatment with a single-pill combination containing enalapril , @ mg , and folic acid , @ mg ( n = @,@ ) or a tablet containing enalapril , @ mg , alone ( n = @,@ ) .


The primary outcome was first stroke .


Secondary outcomes included first ischemic stroke ; first hemorrhagic stroke ; MI ; a composite of cardiovascular events consisting of cardiovascular death , MI , and stroke ; and all-cause death .


During a median treatment duration of @ years , compared with the enalapril alone group , the enalapril-folic acid group had a significant risk reduction in first stroke ( @ % of participants in the enalapril-folic acid group vs @ % in the enalapril alone group ; hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @-@ @ ) , first ischemic stroke ( @ % with enalapril-folic acid vs @ % with enalapril alone ; HR , @ ; @ % CI , @-@ @ ) , and composite cardiovascular events consisting of cardiovascular death , MI , and stroke ( @ % with enalapril-folic acid vs @ % with enalapril alone ; HR , @ ; @ % CI , @-@ @ ) .


The risks of hemorrhagic stroke ( HR , @ ; @ % CI , @-@ @ ) , MI ( HR , @ ; @ % CI , @-@ @ ) , and all-cause deaths ( HR , @ ; @ % CI , @-@ @ ) did not differ significantly between the @ treatment groups .


There were no significant differences between the @ treatment groups in the frequencies of adverse events .


Among adults with hypertension in China without a history of stroke or MI , the combined use of enalapril and folic acid , compared with enalapril alone , significantly reduced the risk of first stroke .


These findings are consistent with benefits from folate use among adults with hypertension and low baseline folate levels .


To establish whether there was a difference in health-related quality of life ( HRQoL ) in people with chronic musculoskeletal disorders ( PwCMSKD ) after participating in a multimodal physiotherapy program ( MPP ) either two or three sessions a week .


Total of @ PwCMSKD participated in this prospective randomised controlled trial .


An individualised MPP , consisting of exercises for mobility , motor-control , muscle strengthening , cardiovascular training , and health education , was implemented either twice a week ( G@ : n = @ ) or three times a week ) ( G@ : n = @ ) for @ year .


HRQoL physical and mental health state ( PHS/MHS ) , Roland Morris disability Questionnaire ( RMQ ) , Neck-Disability-Index ( NDI ) and Western Ontario and McMaster Universities ' Arthritis Index ( WOMAC ) were used to measure outcomes of MPP for people with chronic low back pain , chronic neck pain and osteoarthritis , respectively .


Measures were taken at baseline , @ weeks ( @ w ) , @ months ( @m ) , and @ year ( @y ) after starting the programme .


No statistically significant differences were found between the two groups ( G@ and G@ ) , except in NDI at @ w ( -@ , ( CI @ % : -@ / @ , p = @ ( scale @-@ ) ) .


All variables showed improvement reaching the following values ( from baseline to @y ) G@ : PHS : @ ( baseline : @ ; ( improvement : @ % ) , MHS : @ ( baseline : @ , @ % ) , HRQoL @ ( baseline : @ , @ % ) ) , HRQoL-VAS @ ( baseline : @ , @ % ) , RMQ @ ( baseline : @ , @ % ) , NDI @ ( baseline : @ , @ % ) , WOMAC @ ( baseline : @ , @ % ) .


G@ : PHS : @ ( baseline : @ , @ % ) , MHS : @ ( baseline : @ , ( @ % ) , HRQoL @ ( baseline : @ , @ % ) , HRQoL-VAS @ ( baseline : @ , @ % ) , RMQ @ ( baseline : @ , @ % ) , NDI @ ( baseline : @ , @ % ) , WOMAC @ ( baseline : @ , @ % ) .


No significant differences between the two groups were found in the outcomes of a MPP except in the NDI at @ weeks , but both groups improved in all variables during the course of @ year under study .


Implications for Rehabilitation A multimodal physiotherapy program ( MPP ) improves quality of life , overall health , and function in people with chronic musculoskeletal disease after an intervention of short , medium and long term .


This implies that twice a week MPP for people with chronic musculoskeletal pain has comparable results to three times a week provision and therefore may have implications in saving resources and cost for patients and service providers without compromising the outcomes of treatment .


These results can be considered not only for therapists , but also for managers who offer the services to optimise the balance cost-effectiveness of the proposed interventions .


The beneficial role of exercise as a treatment approach in Huntington 's disease ( HD ) has support from both preclinical work and small-scale studies ; however , there have been no controlled studies of gym-based exercise in people with HD .


This phase @ randomized trial ( ISRCTN @ ) assessed feasibility , safety , acceptability , and benefit of a structured exercise program .


Thirty-one participants ( @ men ; mean -LSB- SD -RSB- age = @ -LSB- @ -RSB- years ) were randomly allocated to intervention ( n = @ ) or control group ( usual care ; n = @ ) .


The intervention entailed a weekly supervised gym session of stationary cycling and resistance exercises , and a twice weekly independent home-based walking program .


Retention and adherence rates and adverse events were recorded .


Acceptability was determined from subjective reports of tolerability and physiological measures recorded during the gym sessions .


Assessment of benefit included measures of physical abilities , disease severity , and quality of life ( @-Item Short Form Health Survey ) .


Analysis of covariance was used to test outcomes of interest .


The retention rate was @ % ( @ of the @ individuals who started the intervention completed it ) and of the @ who completed the program , @ attended more than @ % ( @/@ ) of the gym sessions .


There were no related adverse events and the intervention was well tolerated by most participants .


The between-group effect estimate for the Mental Component Summary score of the @-Item Short Form Health Survey ( n = @ ; intervention , n = @ ; control ) was @ ( @ % CI : @-@ @ ) Moderate effect sizes for cognitive outcomes and measures of walking were also observed .


Observed effect sizes for clinical outcomes suggest the structured exercise program has benefit for persons with HD ; larger scale trials are warranted.Video Abstract available ( see Video , Supplemental Digital Content @ , http://links.lww.com/JNPT/A@ ) for more insights from the authors .


To optimize positive outcomes , the design of new pharmacy services should consider the preferences of consumers with chronic condition ( s ) and their carers .


( i ) To evaluate the relative importance of community pharmacy service characteristics , from the perspective of consumers with chronic condition ( s ) and carers ; ( ii ) To compare consumer and carer preferences to health professional beliefs about ideal service characteristics for consumers .


A discrete choice experiment was completed by consumers with chronic condition ( s ) and/or carers ( n = @ ) and health professionals ( n = @ ) , recruited from four regions in Australia .


Participants were each randomized to one survey version containing four ( from a total @ ) different choices between two new pharmacy services .


Consumer and carer participants were also given an ` opt out ' alternative of current service .


Each service was described using six attributes related to pharmacy service characteristics : continued medicines supply , continuity and coordinated care , location , medication management , education and information , and cost .


Consumers and carers placed highest priority on continued medicines supply by a pharmacist for regular and symptom flare up medicines ( @ priority points ) , a pharmacy located within a ` one-stop ' health center ( @ points ) and home delivery of medicines ( @ points ) .


Although continuedmedicines supply was most important for consumers and carers , pharmacy location was perceivedby health professionals to be the most important characteristic for consumers .


Participants were less inclined to choose new services if their current pharmacy offered high quality services thatwere person-centered , easy to access and responsive to their needs .


Younger , more highly educated and employed participants , and those with established condition ( s ) were more likely to choose new services .


Person-centered care is a fundamental tenet for pharmacy services .


The provision of continued medicines supply ( e.g. through pharmacist prescribing ) , convenient and coordinated care delivered through a one stop health centre , and home delivery of medicines , should be prioritized when planning pharmacy services to best assist consumers to manage chronic conditions .


Farm youth continue to experience high rates of injury and deaths as a result of agricultural activities .


Farm machinery , especially tractors , is the most common cause of casualties to youth .


A Roll-Over Protection Structure ( ROPS ) along with a fastened seatbelt can prevent almost all injuries and fatalities from tractor overturns .


Despite this knowledge , the use of seatbelts by farmers on ROPS tractors remains low .


This study treats farm safety as a family issue and builds on the central role of parents as teachers and role models of farm safety for youth .


This research study used a longitudinal , repeated-measures , randomized-control design in which youth @-@years of age were randomly assigned to either of two intervention groups ( parent-led group and staff-led group ) or the control group .


Fathers in the parent-led group were less likely to operate ROPS tractors without a seatbelt compared with other groups .


They were more likely to have communicated with youth about the importance of wearing seatbelts on ROPS tractors .


Consequently , youth in the parent-led group were less likely to operate a ROPS tractor without a seatbelt than the control group at post-test .


This randomized control trial supports the effectiveness of a home-based , father-led farm safety intervention as a promising strategy for reducing youth as well as father-unsafe behaviors ( related to tractor seatbelts ) on the farm .


This intervention appealed to fathers ' strong motivation to practice tractor safety for the sake of their youth .


Involving fathers helped change both father as well as youth unsafe tractor-seatbelt behaviors .


Several studies have confirmed dramatic changes in skin surface parameters during the winter months .


Although there are many studies supporting the positive effects of topical treatment , there are no published studies demonstrating the effects of oral supplementation in the prevention of negative skin changes during winter .


The purpose of this study was to evaluate the efficacy of an oral micronutrient supplement in preventing the negative effects of winter weather on skin quality using noninvasive biometrologic instruments .


This study included @ healthy female volunteers aged @-@ years with phototype II-IV skin .


Randomization was balanced .


Two tablets of a micronutrient supplement ( Perfectil Platinum ) or placebo were administered once daily for @ months .


The volunteers were examined at baseline , after @ months , and @ weeks after termination of treatment ( month @ ) .


The evaluation included skin microrelief by Visioscan as the main outcome , and the secondary outcomes were results on standard macrophotography , skin tension by Reviscometer , skin high-frequency ultrasound , and self-assessment .


For all pseudoroughness and microrelief indicators , there was a significant increase from baseline to month @ in the placebo group ( P < @ ) but no change in the active group .


Descriptive statistics for the mean minimum , mean maximum , and minimum to maximum ratio on the nonexposed study zone showed a significant and dramatic difference between baseline and month @ and between baseline and month @ ( P < @ ) in the active group , indicating decreasing anisotropy of the skin .


High-frequency ultrasound on the exposed study zone revealed that skin thickness was significantly decreased in the placebo group during winter but was stable in the treated group ( P < @ ) .


The photography scaling and self-assessment questionnaire revealed no significant changes in either group .


These results indicate that the skin is prone to seasonal changes during winter , particularly in exposed areas .


The data also indicate that oral supplementation can be a safe treatment , with no serious side effects , and may prevent or even eliminate the negative effects of winter on the skin .


To compare the effectiveness of in vitro fertilisation with single embryo transfer or in vitro fertilisation in a modified natural cycle with that of intrauterine insemination with controlled ovarian hyperstimulation in terms of a healthy child .


Multicentre , open label , three arm , parallel group , randomised controlled non-inferiority trial .


@ centres in the Netherlands .


Couples seeking fertility treatment after at least @ months of unprotected intercourse , with the female partner aged between @ and @ years , an unfavourable prognosis for natural conception , and a diagnosis of unexplained or mild male subfertility .


Three cycles of in vitro fertilisation with single embryo transfer ( plus subsequent cryocycles ) , six cycles of in vitro fertilisation in a modified natural cycle , or six cycles of intrauterine insemination with ovarian hyperstimulation within @ months after randomisation .


The primary outcome was birth of a healthy child resulting from a singleton pregnancy conceived within @ months after randomisation .


Secondary outcomes were live birth , clinical pregnancy , ongoing pregnancy , multiple pregnancy , time to pregnancy , complications of pregnancy , and neonatal morbidity and mortality


@ couples were randomly assigned between January @ and February @ ; @ were allocated to in vitro fertilisation with single embryo transfer , @ to in vitro fertilisation in a modified natural cycle , and @ to intrauterine insemination with controlled ovarian hyperstimulation .


Birth of a healthy child occurred in @ ( @ % ) couples in the in vitro fertilisation with single embryo transfer group , @ ( @ % ) in the in vitro fertilisation in a modified natural cycle group , and @ ( @ % ) in the intrauterine insemination with controlled ovarian hyperstimulation group .


This corresponds to a risk , relative to intrauterine insemination with ovarian hyperstimulation , of @ ( @ % confidence interval @ to @ ) for in vitro fertilisation with single embryo transfer and @ ( @ to @ ) for in vitro fertilisation in a modified natural cycle .


These @ % confidence intervals do not extend below the predefined threshold of @ for inferiority .


Multiple pregnancy rates per ongoing pregnancy were @ % ( @/@ ) after in vitro fertilisation with single embryo transfer , @ % ( @/@ ) after in vitro fertilisation in a modified natural cycle , and @ % ( @/@ ) after intrauterine insemination with ovarian hyperstimulation ( one sided P = @ for in vitro fertilisation with single embryo transfer compared with intrauterine insemination with ovarian hyperstimulation ; one sided P = @ for in vitro fertilisation in a modified natural cycle compared with intrauterine insemination with controlled ovarian hyperstimulation ) .


In vitro fertilisation with single embryo transfer and in vitro fertilisation in a modified natural cycle were non-inferior to intrauterine insemination with controlled ovarian hyperstimulation in terms of the birth of a healthy child and showed comparable , low multiple pregnancy rates.Trial registration Current Controlled Trials ISRCTN@ ; Nederlands Trial Register NTR@ .


The comparative risks and benefits of early compared with delayed cord clamping in the preterm neonate remain unclear .


Our objective was to evaluate the short-term effects of delayed clamping of the umbilical cord in preterm neonates .


We conducted a randomized controlled trial comparing immediate with delayed cord clamping among preterm neonates born between @ and @ weeks of gestation .


The primary study outcome was the need for blood transfusion .


To detect a @ % reduction in this outcome ( from @ to @ % ) with a two-tailed of @ and of @ required @ patients equally divided into two groups .


A total of @ women were randomized , @ to the delayed and @ to the immediate clamp group .


The groups were similar with respect to baseline characteristics .


The mean gestational age at delivery was @ weeks in the delayed compared with @ weeks in the immediate clamp group ( P = @ ) .


There was no statistically significant difference between groups with regard to the need for blood transfusion : @ of @ ( @ % ) in the delayed cord clamp group received one or more blood transfusion compared with @ of @ ( @ % ) in the immediate clamp group ( P = @ ) .


The rates of various neonatal outcomes including respiratory distress syndrome , periventricular leukomalacia , necrotizing enterocolitis , anemia of prematurity , and neonatal morality did not differ significantly between the groups .


However , the mean initial hemoglobin ( @ compared with @ g/dL , P = @ ) and hematocrit ( @ compared with @ , P = @ ) was significantly higher in the delayed group .


In the delayed clamp group , @ % ( @/@ ) of neonates had intraventricular hemorrhage compared with @ % ( @/@ ) in the immediate clamp group ( P = @ ) .


Delayed cord clamping for @ seconds did not decrease the need for blood transfusion among preterm neonates .


Acute hamstring re-injuries are common and hard to predict .


The aim of this study was to investigate the association between clinical and imaging findings and the occurrence of hamstring re-injuries .


We obtained baseline data ( clinical and MRI findings ) of athletes who sustained an acute hamstring injury within @days of initial injury .


We also collected data of standardised clinical tests within @days after return to play ( RTP ) .


The number of re-injuries was recorded within @months .


We analysed the association between the possible predictive variables and re-injuries with a multivariate Cox proportional-hazards regression model .


Eighty patients were included at baseline and @ patients could be included in the final analysis because data after RTP were not available in @ cases .


There were @ re-injuries ( @ % ) .


None of the baseline MRI findings were univariately associated with re-injury .


A higher number of previous hamstring injuries ( adjusted OR ( AOR ) @ ; @ % CI @ to @ ) , more degrees of active knee extension deficit after RTP ( AOR @ ; @ % CI @ to @ ) , isometric knee flexion force deficit at @ after RTP ( AOR @ ; @ % CI @ to @ ) and presence of localised discomfort on hamstring palpation after RTP ( AOR @ ; @ % CI @ to @ ) were significant independent predictors of re-injury .


Athletes with localised discomfort on hamstring palpation just after RTP were consequently almost four times more likely to sustain a re-injury .


The number of previous hamstring injuries , active knee extension deficit , isometric knee flexion force deficit at @ and presence of localised discomfort on palpation just after RTP are associated with a higher hamstring re-injury rate .


None of the baseline MRI parameters was a predictor of hamstring re-injury .


Intra-arterial treatment ( IAT ) in patients with acute ischemic stroke ( AIS ) can be performed with or without general anesthesia ( GA ) .


Previous studies suggested that IAT without the use of GA ( non-GA ) is associated with better clinical outcome .


Nevertheless , no consensus exists about the anesthetic management during IAT of AIS patients .


This study investigates the association between type of anesthesia and clinical outcome in a large cohort of patients with AIS treated with IAT .


All consecutive patients with AIS of the anterior circulation who received IAT between @ and @ in @ Dutch hospitals were included in the study .


Primary outcome was functional outcome on the modified Rankin Scale at discharge .


Difference in primary outcome between GA and non-GA was estimated using multiple ordinal regression analysis , adjusting for age , stroke severity , occlusion of the internal carotid artery terminus , previous stroke , atrial fibrillation , and diabetes mellitus .


Three hundred forty-eight patients were included in the analysis ; @ patients received GA and @ patients did not receive GA. .


Non-GA was significantly associated with good clinical outcome ( odds ratio @ , @ % confidence interval @-@ @ ) .


After adjusting for prespecified prognostic factors , the point estimate remained similar ; statistical significance , however , was lost ( odds ratio @ , @ % confidence interval @-@ @ ) .


Our study suggests that patients with AIS of the anterior circulation undergoing IAT without GA have a higher probability of good clinical outcome compared with patients treated with general anesthesia .


Restenosis is a limitation of endovascular interventions performed in the superficial femoral artery ( SFA ) .


Preclinical studies have demonstrated that the perivascular delivery of tissue-engineered allogeneic aortic endothelial cells ( PVS-@ ) reduced stenosis in porcine models of SFA revascularization .


The purpose of this study was to investigate the safety and feasibility of percutaneous PVS-@ delivery after angioplasty and stenting in the SFA of patients with peripheral artery disease .


In this phase I open-label trial , @ patients ( average lesion length of @ @ cm and @ % stenosis ) were treated with PVS-@ : @ in a low-dose cohort ( cohort A ) and @ in a high-dose cohort ( cohort B ) .


The primary objective was to demonstrate the safety ( incidence of major adverse events ) of PVS-@ within @ weeks after surgery .


Secondary end points included assessments of resting ankle-brachial index ( ABI ) in the treated leg , Fontaine class , and time to target lesion revascularization ( TLR ) .


No patient had a major adverse event within @ weeks .


One patient required a limb amputation at @ weeks .


At @ weeks , cohort A and cohort B patients maintained a @ % and @ % increase in ABI compared with baseline , respectively ; @ % of cohort A and @ % of cohort B improved by @ Fontaine classification stage , and the TLR rate was @ % for cohort A and @ % for cohort B.


Percutaneous local delivery of PVS-@ is a well-tolerated and novel therapeutic approach that may be a suitable treatment for patients after endovascular intervention of the SFA .


Larger randomized trials are needed to determine if PVS-@ can improve ABI and reduce TLR rates .


Prior studies have demonstrated a significant gap between guideline-based recommendations and clinical practice in the management of acute ischemic stroke ( AIS ) in China .


This study implements a targeted multifaceted quality improvement intervention in AIS patients and identifies the feasibility and efficacy of this intervention .


This is a multicenter , @-arm , open-label , cluster-randomized trial involving @ clusters ( hospitals ) from China National Network of Stroke Research .


Hospitals are randomized to receive a targeted multifaceted quality improvement intervention ( experimental group ) or routine standard of care ( control group ) .


The multifaceted intervention includes an evidence-based clinical pathway , written care protocols , a quality coordinator , and a monitoring and feedback system of performance measures .


The number of enrolled patients in the trial will be @,@ .


Primary outcome is the measure of the adherence to AIS evidence-based performance measures including the composite measure ( defined as the total number of interventions performed among eligible patients divided by the total number of possible interventions among eligible patients ) and the all-or-none measure ( defined as the proportion of eligible patients who receive all of the performance measure interventions for which they are eligible ) .


Secondary patient outcomes include inhospital death ; a new vascular event ; disability ; and all-cause death at @ , @ , and @ months after initial symptom onset .


All analyses will be performed according to the intention-to-treatment principle and accounted for clustering using generalized estimating equations .


If proven effective , this targeted multifaceted intervention model will be extended nationwide as a model to bridge the evidence-based gap in the AIS management in China .


Administration of secretin improves noninvasive imaging of the pancreatic duct with magnetic resonance cholangiopancreatography ( MRCP ) .


We performed a large prospective study to investigate whether synthetic human secretin ( RG@ ) - stimulated MRCP detects pancreatic duct abnormalities with higher levels of sensitivity than MRCP .


We performed a phase @ , multicenter , baseline-controlled study of patients with acute or acute recurrent pancreatitis who were scheduled to undergo endoscopic retrograde cholangiopancreatography ( ERCP ) between March @ , @ , and October @ , @ .


Patients underwent a baseline MRCP that was immediately followed by administration of RG@ and repeat MRCP and then underwent ERCP within @ days ; they were followed up for @ days .


MRCP and ERCP images were read centrally by @ radiologists and @ endoscopists , respectively , who were all independent and blinded ; pancreatic duct abnormalities were evaluated .


The accuracy of MRCP was evaluated using ERCP as the standard .


In total , @ patients were enrolled in the study ; @ MRCP image sets were assessed , and @ patients had evaluable ERCPs .


Pancreatic duct abnormalities were observed in @ % of ERCP images .


All radiologists identified duct abnormalities in RG@-cin MRCP image sets with significantly higher levels of sensitivity ( P < @ ) than in images from MRCP , with minimal loss of specificity .


Adverse events were reported in @ % of patients after MRCP and @ % after ERCP .


Of the @ patients who experienced a serious adverse event , @ ( @ % ) and @ ( @ % ) of the events were reported to be temporally associated with MRCP and ERCP , respectively .


The adverse events most frequently considered related to RG@ were nausea , abdominal pain , and flushing ; most were mild .


Compared with images from MRCP , those from RG@-stimulated MRCP are improved in many aspects and could aid in diagnosis and clinical decision making for patients with acute , acute recurrent , or chronic pancreatitis .


RG@-enhanced MRCP might also better identify patients in need of therapeutic ERCP ( ClinicalTrials.gov , Number : NCT@ ) .


Stress , depression , and anxiety affect @ % to @ % of pregnant women .


However , substantial barriers to psychosocial assessment exist , resulting in less than @ % of prenatal care providers assessing and treating mental health problems .


Moreover , pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider .


Identifying screening and assessment tools and procedures that are acceptable to both women and service providers , cost-effective , and clinically useful is needed .


The primary objective of this randomized , parallel-group , superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment ( e-screening ) compared to paper-based screening .


Secondary objectives are to compare the two modes of screening on : ( @ ) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk ; ( @ ) the level of disclosure of symptoms ; ( @ ) the factors associated with feasibility , acceptability , and disclosure ; ( @ ) the psychometric properties of the e-version of the assessment tools ; and ( @ ) cost-effectiveness .


A sample of @ women will be recruited from large , primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city .


Pregnant women are eligible to participate if they : ( @ ) receive care at one of the recruitment sites ; ( @ ) are able to speak/read English ; ( @ ) are willing to be randomized to e-screening ; and ( @ ) are willing to participate in a follow-up diagnostic interview within @ week of recruitment .


Allocation is by computer-generated randomization .


Women in the intervention group will complete an online psychosocial assessment on a computer tablet , while those in the control group will complete the same assessment in paper-based form .


All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within @ week of recruitment .


Research assistants conducting diagnostic interviews and physicians will be blinded .


A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention .


We hypothesize that mental health e-screening in primary care maternity settings and high-risk antenatal units will be as or more feasible , acceptable , and capable of detecting depression , anxiety , and psychosocial risk compared to paper-based screening .


To determine the effects of bevacizumab on patient-reported outcomes ( PROs ; secondary end point ) in the AURELIA trial .


Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone ( CT ) or with bevacizumab ( BEV-CT ) .


PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module @ ( EORTC QLQ-OV@ ) and Functional Assessment of Cancer Therapy-Ovarian Cancer symptom index ( FOSI ) at baseline and every two or three cycles ( @/@ weeks ) until disease progression .


The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a @ % ( @-point ) absolute improvement on the QLQ-OV@ abdominal/GI symptom subscale ( items @-@ ) at week @/@ .


Patients with missing week @/@ questionnaires were included as unimproved .


Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures ( MMRM ) analysis .


Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data .


Baseline questionnaires were available from @ % of @ randomly assigned patients .


More BEV-CT than CT patients achieved a @ % improvement in abdominal/GI symptoms at week @/@ ( primary PRO end point , @ % v @ % ; difference , @ % ; @ % CI , @ to @ ; P = @ ) .


MMRM analysis covering all time points also favored BEV-CT ( difference , @ points ; @ % CI , @ to @ ; P = @ ) .


More BEV-CT than CT patients achieved @ % improvement in FOSI at week @/@ ( @ % v @ % ; difference , @ % ; @ % CI , @ % to @ % ; P = @ ) .


Sensitivity analyses gave similar results and conclusions .


Bevacizumab increased the proportion of patients achieving a @ % improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer .


Breastfeeding is associated with significant positive health outcomes for mothers and infants .


However , despite recommendations from the World Health Organization , exclusive breastfeeding for six months is uncommon .


Increased breastfeeding support early in the postpartum period may be effective in improving breastfeeding maintenance .


This trial will evaluate two community-based interventions to increase breastfeeding duration in Local Government Areas ( LGAs ) in Victoria , Australia .


A three-arm cluster randomised controlled trial design will be used .


Victorian LGAs with a lower than average rate of any breastfeeding at discharge from hospital and more than @ births per year that agree to participate will be randomly allocated to one of three trial arms : @ ) standard care ; @ ) home-based breastfeeding support ; or @ ) home-based breastfeeding support plus access to a community-based breastfeeding drop-in centre .


The services provided in LGAs allocated to ` standard care ' are those routinely available to postpartum women .


LGAs allocated to the home-based visiting intervention will provide home-visits to women who are identified as at risk of breastfeeding cessation in the early postnatal period .


These visits will be provided by Maternal and Child Health Nurses who have received training to provide the intervention ( SILC-MCHNs ) .


In areas allocated to receive the second intervention , in addition to home-based breastfeeding support , community breastfeeding drop-in centres will be made available , staffed by a SILC-MCHN .


The interventions will run in LGAs for a nine to twelve month period depending on birth numbers .


The primary outcome is the proportion of infants receiving any breast milk at four months of age .


Breastfeeding outcomes will be obtained from routinely collected Maternal and Child Health centre data and from a new data item collecting infant feeding ` in the last @ hours ' .


Information will also be obtained directly from women via a postal survey .


A comprehensive process evaluation will be conducted .


This study will determine if early home-based breastfeeding support by a health professional for women at risk of stopping breastfeeding , with or without access to a community-based breastfeeding drop-in centre , increases breastfeeding duration in Victorian LGAs with low breastfeeding rates .


Insulin-resistant states , including type @ diabetes ( T@D ) and prediabetes , are associated with elevated cardiovascular ( CV ) risk .


Aleglitazar is a dual peroxisome proliferator-activated receptor / agonist with favorable insulin-sensitizing and glucose-lowering actions , favorable effects on blood lipids , and an acceptable safety profile in short-time studies .


Therefore , it was hypothesized that aleglitazar would reduce CV morbidity and mortality in patients with T@D mellitus and prediabetes ( defined as glycosylated hemoglobin @ % to < @ % ) with previous CV complications .


ALEPREVENT was a phase III , multicenter , randomized , double-blind , trial comparing aleglitazar @ g or placebo daily in patients with T@D or prediabetes with established , stable CV disease .


The intended sample size was @,@ with a primary efficacy measure of major adverse CV events .


However , the trial was halted prematurely after @,@ patients had been randomized because of futility and an unfavorable benefit risk ratio in another CV outcomes trial evaluating aleglitazar .


At study termination after @ @ days of treatment , data had been collected from @,@ patients ( @,@ with T@D and @ with pre-T@D ) .


Despite the brief duration of treatment , aleglitazar induced favorable changes in glycosylated hemoglobin and blood lipids , similar for participants with T@D or prediabetes .


However , compared with placebo , aleglitazar increased the incidence of hypoglycemia ( @ vs @ ; P < @ ) , and muscular events ( @ vs@ ; P = @ ) .


Even within a short duration of exposure , aleglitazar was associated with excess adverse events , corroborating the findings of a larger and longer trial in T@D .


Coupled with the previous failure of several other peroxisome proliferator-activated receptor / activators , this class now holds little promise for CV therapeutics .


Monopolar electrosurgery is the gold standard for surgical preparation in thoracoscopic spine procedures .


However , use of ultrasound scissors could decrease blood loss , accelerate the preparation time and improve patient safety , while minimizing operative costs .


This trial compares both preparation techniques for ventral thoracoscopic spondylodesis .


The study design is an open , prospective , randomized , and double-blinded two-armed clinical trial performed in two centres .


Forty-one patients with vertebral body fractures from T@ to L@ were included .


Primary endpoint : preparation time .


Secondary endpoints : blood loss , organ injuries , duration of hospitalization .


Primary and secondary endpoints did not differ significantly between groups ( p level @ ) .


Increased blood loss ( @ ml or more ) was eliminated with ultrasound scissors ( p = @ ) .


Primary and secondary endpoints did not differ significantly between the two preparation techniques .


The use of either ultrasound scissors or electric scalpel offers safe and effective preparation for thoracoscopic spine surgery .


Delirium is frequently diagnosed in critically ill patients and is associated with poor clinical outcomes .


Haloperidol is the most commonly used drug for delirium despite little evidence of its effectiveness .


The aim of this study was to establish whether early treatment with haloperidol would decrease the time that survivors of critical illness spent in delirium or coma .


We did this double-blind , placebo-controlled randomised trial in a general adult intensive care unit ( ICU ) .


Critically ill patients ( @ years ) needing mechanical ventilation within @ h of admission were enrolled .


Patients were randomised ( by an independent nurse , in @:@ ratio , with permuted block size of four and six , using a centralised , secure web-based randomisation service ) to receive haloperidol @ mg or @ % saline placebo intravenously every @ h , irrespective of coma or delirium status .


Study drug was discontinued on ICU discharge , once delirium-free and coma-free for @ consecutive days , or after a maximum of @ days of treatment , whichever came first .


Delirium was assessed using the confusion assessment method for the ICU ( CAM-ICU ) .


The primary outcome was delirium-free and coma-free days , defined as the number of days in the first @ days after randomisation during which the patient was alive without delirium and not in coma from any cause .


Patients who died within the @ day study period were recorded as having @ days free of delirium and coma .


ICU clinical and research staff and patients were masked to treatment throughout the study .


Analyses were by intention to treat .


This trial is registered with the International Standard Randomised Controlled Trial Registry , number ISRCTN@ .


@ patients were randomised , @ were included in the final analysis ( @ haloperidol , @ placebo ) .


Patients in the haloperidol group spent about the same number of days alive , without delirium , and without coma as did patients in the placebo group ( median @ days -LSB- IQR @-@ -RSB- vs @ days -LSB- @-@ -RSB- days ; p = @ ) .


The most common adverse events were oversedation ( @ patients in the haloperidol group vs six in the placebo group ) and QTc prolongation ( seven patients in the haloperidol group vs six in the placebo group ) .


No patient had a serious adverse event related to the study drug .


These results do not support the hypothesis that haloperidol modifies duration of delirium in critically ill patients .


Although haloperidol can be used safely in this population of patients , pending the results of trials in progress , the use of intravenous haloperidol should be reserved for short-term management of acute agitation .


A recently published study showed the safety and efficacy of LSD-assisted psychotherapy in patients with anxiety associated with life-threatening diseases .


Participants of this study were included in a prospective follow-up .


@ months after finishing LSD psychotherapy , @ participants were tested for anxiety ( STAI ) and participated in a semi-structured interview .


A Qualitative Content Analysis ( QCA ) was carried out on the interviews to elaborate about LSD effects and lasting psychological changes .


None of the participants reported lasting adverse reactions .


The significant benefits as measured with the STAI were sustained over a @-month period .


In the QCA participants consistently reported insightful , cathartic and interpersonal experiences , accompanied by a reduction in anxiety ( @ % ) and a rise in quality of life ( @ % ) .


Evaluations of subjective experiences suggest facilitated access to emotions , confrontation of previously unknown anxieties , worries , resources and intense emotional peak experiences la Maslow as major psychological working mechanisms .


The experiences created led to a restructuring of the person 's emotional trust , situational understanding , habits and world view .


LSD administered in a medically supervised psychotherapeutic setting can be safe and generate lasting benefits in patients with a life-threatening disease .


Explanatory models for the therapeutic effects of LSD warrant further study .


This study aimed to evaluate the effectiveness of a static ground reaction ankle foot orthosis and strapping system on improving gait parameters in children with spastic diplegic cerebral palsy .


The current study was conducted at the physical therapy faculty of Cairo University , Egypt .


This study included @ children of both sexes , aged @ to @ years .


Three-armed randomized control trial .


Participants in all groups received a traditional neuro-developmental physical therapy program that included standing and gait training exercises .


Children in group A performed the training program without any orthotic management , in group B with the TheraTogs strapping system , and in group C with the TheraTogs strapping system and static ground reaction ankle foot orthoses .


Children underwent treatment for two hours daily , except on weekends , for twelve successive weeks .


Gait speed , cadence , stride length , and hip and knee flexion angles in the mid-stance phase were evaluated pre-and post-treatment using a three-dimensional motion analysis system ( pre-reflex system ) .


Statistically significant differences were recorded among the three groups post-treatment in gait speed , cadences , and stride length .


The P-values for these variable differences were @ , @ , and @ respectively .


Significant post-treatment differences were also recorded for bilateral hip-and knee-flexion angles .


For all measured parameters , better significant results were registered for group C than for the other groups .


Orthotic intervention composed of a static ground reaction ankle foot orthosis combined with the TheraTogs strapping system improves gait more than conventional treatment with or without TheraTogs in children with spastic diplegic cerebral palsy .


To investigate if the cramp threshold frequency ( CTF ) can be altered by electrical muscle stimulation in a shortened position .


A total of @ healthy male sport students were randomly allocated to an intervention ( IG , n = @ ) and a non-treatment control group ( CG , n = @ ) .


Calf muscles of both legs in the IG were stimulated equally twice a week over @ weeks .


The protocol was @ s on , @ s off , @ s impulse width , @ Hz above the individual CTF , and was at @ % of the maximal tolerated stimulation energy .


One leg was stimulated in a shortened position , inducing muscle cramps ( CT ) , while the opposite leg was fixated in a neutral position at the ankle , hindering muscle cramps ( nCT ) .


CTF tests were performed prior to the first and @ h after the @ ( th ) ( @ w ) and @ ( th ) ( @ w ) training session .


After @ w , the CTF had significantly ( p < @ ) increased in CT calves from @ Hz to @ Hz , while it remained unchanged in nCT ( pre : @ Hz , mid : @ Hz ) and in both legs of the CG ( pre : @ Hz , mid : @ Hz ) .


Only CT saw further insignificant increases in the CTF .


The applied stimulation energy ( mA s ) positively correlated with the effect on the CTF ( r = @ ; p < @ ) .


The present study may be useful for developing new non-pharmacological strategies to reduce cramp susceptibility .


To determine the effects of addition of different dosages of gonadotrophin releasing hormone agonist ( GnRH-a ) to routine luteal phase support ( LPS ) on implantation and pregnancy rates .


Three hundred infertile couples who were treated by intracytoplasmic sperm injection and embryo transfer ( ICSI-ET ) following controlled ovarian stimulation ( COS ) with long luteal GnRH agonist protocol were enrolled .


All women received @ mg/day vaginal micronized progesterone plus @ mg @ estradiol for LPS starting from the day of oocyte retrieval .


Patients ( n = @ ) were randomized into three treatment groups .


Group A ( n = @ ) received leuprolide acetate @ mg s.c. injection @ days after ET in addition to routine LPS .


Group B ( n = @ ) received two sequential doses of leuprolide acetate @ mg s.c. injections @ and @ days after ET in addition to routine LPS .


Control group ( n = @ ) received only the routine LPS .


A total of @ patients completed the study .


The groups were comparable in terms of baseline demographic parameters including age , duration of infertility and day @ levels of FSH and estradiol .


The cycle parameters of the groups were also comparable regarding the E@ level on day of hCG , number of retrieved oocytes , number of day @ embryos , number of embryos transferred , and endometrial thickness on both days of OPU and ET .


The implantation rates were similar in between the Groups A , B , and control group ( @ % and @ % vs. @ % , respectively ; P = @ ) .


The clinical pregnancy rates and miscarriage rates were similar in between the groups .


The ongoing pregnancy rates were @ % in control group , @ % in Group A and @ % in Group B ( P = @ ) .


The OHSS rates were comparable in between the groups .


The multiple pregnancy rates were significantly higher in Groups A and B than in control group ( @ % and @ % vs. @ % , respectively ; P = @ ) .


The implantation , clinical pregnancy and ongoing pregnancy and multiple pregnancy rates seem to be increased with the addition of GnRH-a to routine luteal phase support .


Obesity-induced chronic inflammation is a key component of the pathogenesis of insulin resistance .


Mounting evidence has demonstrated anti-inflammatory characteristics for vitamin D. Although analogues of vitamin D@ have extensively been used in the treatment of various chronic inflammatory diseases , to our knowledge , no such research is conducted in regards with obesity .


The aim of this double blind clinical trial study is to investigate whether alphacalcidol treatment in obese subjects can affect the cytokine profile and insulin resistance .


Moreover , we evaluated the pathways of vitamin D receptor ( VDR ) , PPAR and PGC@ gene expressions which may lead to insulin resistance following treatment with either alphacalcidol or placebo .


A total of @ obese participants ( BMI@ ) were recruited for the current double blind clinical trial study .


Patients were divided into two intervention ( N. = @ ) and control groups ( N. = @ ) based on the stratified randomized method .


One-Alpha Capsules @ microgram : alfacalcidol ( @ - hydroxyvitamin D@ ) and placebo were given to subjects once a day for @ weeks .


Analysis of body composition was performed with use of Body Composition Analyzer .