In all groups , mean NIHSS score was 13 , 42.2 % of patients scored 14 and on admission , 42.2 % of patients had consciousness impairment of different severity .


Cytoflavin treatment was more efficient than ascorbic acid that can be explained by different pharmacologic mechanisms .


Treatment with cytoflavin for 10 days resulted in a significant decrease of ischemia zone volume by 25.2 % , treatment with cytoflavin for 20 days - by 29.0 % , which was associated with better outcomes in neurologic and functional status .


Ascorbic acid demonstrated no effect on morphologic parameters .


Prolonged treatment with cytoflavin in critically ill patients led to significant improvement in clinical and morphologic variables compared to the 10-day course .


In patients with less severe condition comparable results were obtained .


Our data justify the need for personalized integrated antioxidant and energy correction therapy .


To assess the effect of an opioid administered topically onto a standardized skin wound in patients without significant comorbidity .


Findings to date are contradictory , often obtained from multimorbid patients with wounds lacking uniformity .


Forty-four patients undergoing surgery for skin grafting were randomly assigned to receive morphine ( 0.25 , 0.75 or 1.25 mg/100cm ( 2 ) wound size ) in hydroxyethylcellulose gel or placebo applied onto the excised split-thickness donor wound at the end of surgery .


Pain , supplementary systemic opioids and adverse effects were assessed during the first 24h after application .


Healing was examined when the dressings were removed .


Morphine doses ranged from 0.25 to 5.4 mg ( mean 1.93 standard deviation 1.34 mg ) .


No differences in pain scores or use of supplementary analgesics were found between the groups .


Serious adverse effects did not occur ; healing was not impaired .


Large intragroup variability was observed for pain scores , wound sizes and supplementary analgesia .


Patients treated with topically applied morphine gel onto standardized skin wounds did not report lower pain scores compared with placebo-treated patients .


Larger groups would be required to arrive at definitive conclusions .


The split-thickness skin graft model can be used for future research .


To prospectively observe the long-term antiviral efficacy and safety of telbivudine ( LDT ) administered as a monotherapy and as a combination therapy with adefovir dipivoxil ( ADV ) in patients diagnosed with chronic hepatitis B ( CHB ) and positivity for hepatitis B e antigen ( HBeAg ) .


A total of 140 patients with HBeAg-positive CHB were randomly divided into treatment groups for LDT monotherapy ( n = 75 ; 600 mg orally , once daily ) and LDT+ADV combination therapy ( n = 65 ; LDT 600 mg plus ADV 10 mg orally , once daily ) .


The shortest treatment course was 96 weeks and the longest was 240 weeks .


At treatment weeks 12 , 24 , 48 ?


, 96 , 144 , 192 , and 240 patients were tested for hepatitis B virus ( HBV ) DNA , HBeAg seroconversion and ALT normalization time ; in addition , the incidence and type of adverse drug reactions were recorded .


Data were statistically analyzed to determine the significance of differences observed between groups .


The rate of patients experiencing more than or equal to 2 log HBV DNA reduction was higher in the LDT + ADV group ( 92.3 % ( 60/65 ) vs. LDT : 86.7 % ( 65/75 ) , X2 = 1.58 ) .


The HBV DNA negative rates of the LDT and LDT + ADV groups were 62.7 % and 61.5 % ( X2 = 0.01 ) at week 24 , 76.0 % and 81.5 % ( X2 = 0.63 ) at week 48 , 80.0 % and 89.2 % ( X2 = 2.2 ) at week 96 , 78.3 % and 93.3 % ( X2 = 3.24 ) at week 144 , 83.7 % and 91.7 % ( X2 = 0.47 ) at week 192 , and 93.3 % and 88.9 % at week 240 ( comparison between two groups for each point P more than 0.05 ) ; both groups showed higher early and rapid sustained HBV DNA negative rates .


For the HBeAg seroconversion , the rates of the LDT and LDT + ADV groups were 17.3 % and 23.1 % ( X2 = 0.71 ) at week 24 , 29.3 % and 30.8 % ( X2 = 0.03 ) at week 48 , 42.7 % and 40.0 % ( X2 = 0.10 ) at week 96 , 55.0 % and 43.3 % ( X2 = 1.08 ) at week 144 , 55.8 % and 66.7 % ( X2 = 0.45 ) at week 192 , and 63.3 % and 66.7 % at week 240 ; however , pairwise comparison showed no statistically significant differences between the groups ( P more than 0.05 ) .


Similarly , there was no significant difference between the two groups in incidence of resistance at week 48 ( 4.0 % and 1.5 % ) , week 96 ( 5.3 % and 3.1 % ) , week 144 ( 10.0 % and 3.3 % , X2 = 1.23 ) , week 192 ( 11.6 % and 8.3 % ) , and week 240 ( 13.3 % and 11.1 % ) ( all P more than 0.05 ) .


Three patients experienced muscle soreness ( LDT , n = 2 ; LDT + ADV , n = 1 ) and two patients experienced increased creatine phosphokinase ( LDT , n = 1 ; LDT + ADV , n = 1 ) ; all side effects resolved spontaneously or with symptom-appropriate treatment .


The long-term efficacy of LDT as a monotherapy or as a combination therapy with ADV was similar and the two different treatment approaches were associated with similar rates of resistance .


The long-term safety was good for both treatment approaches .


To assess the efficacy and safety of inhaled nebulized hypertonic saline ( HS ) solution in infants with acute bronchiolitis .


Totally 129 patients with acute bronchiolitis ( clinical severity score 4 , aged 2-18 months ) admitted to the Capital Institute of Pediatrics from November 2012 to January 2013 were enrolled .


All the subjects were assigned to receive 1.5 ml compound ipratropium bromide solution for inhalation and 1 ml budesonide firstly , twice a day .


Then , the subjects were randomized to receive 2 ml doses of nebulized 5 % HS ( Group A ) , 3 % HS ( Group B ) or 0.9 % NS ( Group C ) , twice a day .


The treatment lasted for 3 days .


Clinical severity scores before treatment and 24 , 48 , 72 h after treatment were documented .


Bronchospasm , nausea and emesis were recorded to assess safety .


A total of 124 patients completed this research.Group A included 40 cases , Group B included 42 cases , Group C included 42 cases .


Demographic characteristics , pre-treatment duration and clinical severity score before treatment were similar among the 3 group.Seventy-two hours after treatment , the clinical severity score of Group A , B , and C were 3.5 ( 1.0 ) , 4.0 ( 1.0 ) and 5.0 ( 0 ) .


At 24 , 48 , and 72 h after treatment , the clinical severity score were significantly different among the three groups ( ( 2 ) = 36.000 , 51.200 , 50.800 , P < 0.05 ) .


One patient in Group A got paroxysmal cough everytime as soon as he received 5 % HS ( 6 times ) .


Other 3 patients in Group A got paroxysmal cough once .


The incidence of adverse effect of Group A was 3.75 % ( 9/240 ) ; no adverse event occurred in other group .


The incidence of adverse effect among this three group was significantly different ( ( 2 ) = 19.13 , P < 0.01 ) .


Inhalation of nebulized 5 % and 3 % hypertonic saline could decrease clinical symptoms of patient with acute bronchiolitis ; 5 % HS was superior to 3 % HS .


But 2 ml dose of 5 % HS may induce paroxysmal cough .


This study tested the effectiveness of moxibustion on pain and function in chronic knee osteoarthritis ( KOA ) and evaluated safety .


A multi-centre , non-blinded , parallel-group , randomised controlled trial compared moxibustion with usual care ( UC ) in KOA .


212 South Korean patients aged 40-70 were recruited from 2011-12 , stratified by mild ( Kellgren/Lawrence scale grades 0/1 ) and moderate-severe KOA ( grades 2/3/4 ) , and randomly allocated to moxibustion or UC for four weeks .


Moxibustion involved burning mugwort devices over acupuncture and Ashi points in affected knee ( s ) .


UC was allowed .


Korean Western Ontario and McMaster Universities Questionnaire ( K-WOMAC ) , Short Form 36 Health Survey ( SF-36v2 ) , Beck Depression Inventory ( BDI ) , physical performance test , pain numeric rating scale ( NRS ) and adverse events were evaluated at 5 and 13 weeks .


K-WOMAC global score at 5 weeks was the primary outcome .


102 patients ( 73 mild , 29 moderate-severe ) were allocated to moxibustion , 110 ( 77 mild , 33 moderate-severe ) to UC .


K-WOMAC global score ( moxibustion 25.42 + / - SD 19.26 , UC 33.60 + / -17.91 , p < 0.01 , effect size = 0.0477 ) , NRS ( moxibustion 44.77 + / -22.73 , UC 56.23 + / -17.71 , p < 0.01 , effect size = 0.0073 ) and timed-stand test ( moxibustion 24.79 + / -9.76 , UC 25.24 + / -8.84 , p = 0.0486 , effect size = 0.0021 ) were improved by moxibustion at 5 weeks .


The primary outcome improved for mild but not moderate-severe KOA .


At 13 weeks , moxibustion significantly improved the K-WOMAC global score and NRS .


Moxibustion improved SF-36 physical component summary ( p = 0.0299 ) , bodily pain ( p = 0.0003 ) , physical functioning ( p = 0.0025 ) and social functioning ( p = 0.0418 ) at 5 weeks , with no difference in mental component summary at 5 and 13 weeks .


BDI showed no difference ( p = 0.34 ) at 5 weeks .


After 1158 moxibustion treatments , 121 adverse events included first ( n = 6 ) and second degree ( n = 113 ) burns , pruritus and fatigue ( n = 2 ) .


Moxibustion may improve pain , function and quality of life in KOA patients , but adverse events are common .


Limitations included no sham control or blinding .


Clinical Research Information Service ( CRIS ) KCT0000130 .


To examine the speed and trajectory of changes in sleep/wake parameters during short-term treatment of insomnia with cognitive-behavioral therapy ( CBT ) alone versus CBT combined with medication ; and to explore the relationship between early treatment response and post-treatment recovery status .


Participants were 160 adults with insomnia ( mean age , 50.3 years ; 97 women , 63 men ) who underwent a six-week course of CBT , singly or combined with 10 mg zolpidem nightly .


The main dependent variables were sleep onset latency , wake after sleep onset , total sleep time , sleep efficiency , and sleep quality , derived from sleep diaries completed daily by patients throughout the course of treatment .


Participants treated with CBT plus medication exhibited faster sleep improvements as evidenced by the first week of treatment compared to those receiving CBT alone .


Optimal sleep improvement was reached on average after only one week for the combined treatment compared to two to three weeks for CBT alone .


Early treatment response did not reliably predict post-treatment recovery status .


Adding medication to CBT produces faster sleep improvement than CBT alone .


However , the magnitude of early treatment response is not predictive of final response after the six-week therapy .


Additional research is needed to examine mechanisms involved in this early treatment augmentation effect and its impact on long-term outcome .


Parapneumonic empyema ( PPE ) is a frequent complication of acute bacterial pneumonia in children .


There is limited evidence regarding the optimal treatment of this condition .


The aim of this study was to compare the efficacy of drainage plus urokinase versus video-assisted thoracoscopic surgery in the treatment of PPE in childhood .


This prospective , randomized , multicenter clinical trial enrolled patients aged < 15 years and hospitalized with septated PPE .


Study patients were randomized to receive urokinase or thoracoscopy .


The main outcome variable was the length of hospital stay after treatment .


The secondary outcomes were total length of hospital stay , number of days with the chest drain , number of days with fever , and treatment failures .


The trial was approved by the ethics committees of all the participating hospitals .


A total of 103 patients were randomized to treatment and analyzed ; 53 were treated with thoracoscopy and 50 with urokinase .


There were no differences in demographic characteristics or in the main baseline characteristics between the 2 groups .


No statistically significant differences were found between thoracoscopy and urokinase in the median postoperative stay ( 10 vs 9 days ) , median hospital stay ( 14 vs 13 days ) , or days febrile after treatment ( 4 vs 6 days ) .


A second intervention was required in 15 % of children in the thoracoscopy group versus 10 % in the urokinase group ( P = .47 ) .


Drainage plus urokinase instillation is as effective as video-assisted thoracoscopic surgery as first-line treatment of septated PPE in children .


The reported coverage of the measles-rubella ( MR ) or measles-mumps-rubella ( MMR ) vaccine is greater than 99.0 % in Zhejiang province .


However , the incidence of measles , mumps , and rubella remains high .


In this study , we assessed MMR seropositivity and disease distribution by age on the basis of the current vaccination program , wherein the first dose of MR is administered at 8 months and the second dose of MMR is administered at 18-24 months .


Cross-sectional serological surveys of MMR antibodies were conducted by collecting epidemiological data in Zhejiang province , China in 2011 .


In total , 1015 participants were randomly selected from two surveillance sites .


Serum MMR-specific immunoglobulin G levels were tested by enzyme-linked immunosorbent assay .


The geometric mean titers and seroprevalence with 95 % confidence intervals ( CIs ) were calculated by age and gender .


Proportions of different dose of vaccine by age by vaccine were also identified .


Statistically significant differences between categories were assessed by the Chi-square test .


Over 95 % seroprevalence rates of measles were seen in all age groups except < 7 months infants .


Children aged 5-9 years were shown lower seropositivity rates of mumps while elder adolescences and young adults were presented lower rubella seroprevalence .


Especially , rubella seropositivity was significantly lower in female adults than in male .


Nine measles cases were unvaccinated or unknown vaccination history .


Among them , 66.67 % ( 6/9 ) patients were aged 20-29 years while 33.33 % ( 3/9 ) were infants aged 8-12 months .


In addition , 57.75 % ( 648/1122 ) patients with mumps were children aged 5-9 years , and 50.54 % ( 94/186 ) rubella cases were aged 15-39 years .


A timely two-dose MMR vaccination schedule is recommended , with the first dose at 8 months and the second dose at 18-24 months .


An MR vaccination speed-up campaign may be necessary for elder adolescents and young adults , particularly young females .


The aim of this study was to investigate the effects of Kinesio Taping ( KT ) on the body functions and activity of children with unilateral spastic cerebral palsy ( CP ) .


This study was designed as a single-blind , randomized , controlled trial .


Thirty children with unilateral spastic CP were randomized and split equally between the KT group ( eight males , seven females ; mean age 9y [ SD 2y 3mo ] range 7-12y ) and the control group ( seven males , eight females ; mean age 9y 7mo [ SD 3y 4mo ] range 7-14y ) receiving usual care .


All participants were evaluated with the Functional Independence Measure for Children ( WeeFIM ) , the Bruininks-Oseretsky Test of Motor Proficiency ( BOTMP ) , the Gross Motor Function Measure ( GMFM ) , short-term muscle power , agility and functional muscle strength tests .


Wilcoxon signed-rank and Mann-Whitney U tests were used to evaluate within and between-group differences respectively .


The level of significance was accepted as p < 0.05 .


There were significant differences in muscle power sprint ( p = 0.003 ) , lateral step-up test right ( p = 0.016 ) , sit to stand ( p = 0.018 ) , attain stand through half knee right ( p = 0.003 ) , BOTMP Gross scores ( p = 0.019 ) , and WeeFIM total ( p = 0.003 ) and self-care scores ( p = 0.022 ) between the groups ( p < 0.05 ) .


Kinesio Taping is a promising additional approach to increase proprioceptive feedback and improve physical fitness , gross motor function , and activities of daily living in children with CP .


To compare the clinical effects between closed reduction and internal fixation ( CRIF ) and total hip arthroplasty ( THA ) for displaced femoral neck fracture .


In this prospective randomized study , 285 patients aged above 65 years with hip fractures ( Garden III or IV ) were included from January 2001 to December 2005 .


The cases were randomly allocated to either the CRIF group or THA group .


Patients with pathological fractures ( bone tumors or metabolic bone disease ) , preoperative avascular necrosis of the femoral head , osteoarthritis , rheumatoid arthritis , hemiplegia , long-term bed rest and complications affecting hip functions were excluded .


During the 5-year follow-up , CRIF group had significantly higher rates of complication in hip joint , general complication and reoperation than THA group ( 38.3 % vs. 12.7 % , P < 0.01 ; 45.3 % vs. 21.7 % , P < 0.01 ; 33.6 % vs. 10.2 % , P < 0.05 respectively ) .


There was no difference in mortality between the two groups .


Postoperative function of the hip joint in THA group recovered favorably with higher Harris scores .


For displaced fractures of the femoral neck in elderly patients , THA can achieve a lower rate of complication and reoperation , as well as better postoperative recovery of hip joint function compared with CRIF .


Induction chemotherapy ( IC ) before radiotherapy lowers distant failure ( DF ) rates in locally advanced squamous cell carcinoma of the head and neck ( SCCHN ) .


The goal of this phase III trial was to determine whether IC before chemoradiotherapy ( CRT ) further improves survival compared with CRT alone in patients with N2 or N3 disease .


Treatment-naive patients with nonmetastatic N2 or N3 SCCHN were randomly assigned to CRT alone ( CRT arm ; docetaxel , fluorouracil , and hydroxyurea plus radiotherapy 0.15 Gy twice per day every other week ) versus two 21-day cycles of IC ( docetaxel 75 mg/m ( 2 ) on day 1 , cisplatin 75 mg/m ( 2 ) on day 1 , and fluorouracil 750 mg/m ( 2 ) on days 1 to 5 ) followed by the same CRT regimen ( IC + CRT arm ) .


The primary end point was overall survival ( OS ) .


Secondary end points included DF-free survival , failure pattern , and recurrence-free survival ( RFS ) .


A total of 285 patients were randomly assigned .


The most common grade 3 to 4 toxicities during IC were febrile neutropenia ( 11 % ) and mucositis ( 9 % ) ; during CRT ( both arms combined ) , they were mucositis ( 49 % ) , dermatitis ( 21 % ) , and leukopenia ( 18 % ) .


Serious adverse events were more common in the IC arm ( 47 % v 28 % ; P = .002 ) .


With a minimum follow-up of 30 months , there were no statistically significant differences in OS ( hazard ratio , 0.91 ; 95 % CI , 0.59 to 1.41 ) , RFS , or DF-free survival .


IC did not translate into improved OS compared with CRT alone .


However , the study was underpowered because it did not meet the planned accrual target , and OS was higher than predicted in both arms .


IC can not be recommended routinely in patients with N2 or N3 locally advanced SCCHN .


To evaluate the effects and costs of three doses of behavioral weight-loss treatment delivered via Cooperative Extension Offices in rural communities .


Obese adults ( N = 612 ) were randomly assigned to low , moderate , or high doses of behavioral treatment ( i.e. , 16 , 32 , or 48 sessions over two years ) or to a control condition that received nutrition education without instruction in behavior modification strategies .


Two-year mean reductions in initial body weight were 2.9 % ( 95 % Credible Interval = 1.7-4 .3 ) , 3.5 % ( 2.0-4 .8 ) , 6.7 % ( 5.3-7 .9 ) , and 6.8 % ( 5.5-8 .1 ) for the control , low - , moderate - , and high-dose conditions , respectively .


The moderate-dose treatment produced weight losses similar to the high-dose condition and significantly larger than the low-dose and control conditions ( posterior probability > 0.996 ) .


The percentages of participants who achieved weight reductions 5 % at two years were significantly higher in the moderate-dose ( 58 % ) and high-dose ( 58 % ) conditions compared with low-dose ( 43 % ) and control ( 40 % ) conditions ( posterior probability > 0.996 ) .


Cost-effectiveness analyses favored the moderate-dose treatment over all other conditions .


A moderate dose of behavioral treatment produced two-year weight reductions comparable to high-dose treatment but at a lower cost .


These findings have important policy implications for the dissemination of weight-loss interventions into communities with limited resources .


Self-report questionnaires are an important method of evaluating lifespan health , exercise , and health-related quality of life ( HRQL ) outcomes among elite , competitive athletes .


Few instruments , however , have undergone formal characterization of their psychometric properties within this population .


To evaluate the validity and reliability of a novel health and exercise questionnaire , the Trojan Lifetime Champions ( TLC ) Health Survey .


Descriptive laboratory study .


A large National Collegiate Athletic Association Division I university .


A total of 63 university alumni ( age range , 24 to 84 years ) , including former varsity collegiate athletes and a control group of nonathletes .


Participants completed the TLC Health Survey twice at a mean interval of 23 days with randomization to the paper or electronic version of the instrument .


Content validity , feasibility of administration , test-retest reliability , parallel-form reliability between paper and electronic forms , and estimates of systematic and typical error versus differences of clinical interest were assessed across a broad range of health , exercise , and HRQL measures .


Correlation coefficients , including intraclass correlation coefficients ( ICCs ) for continuous variables and agreement statistics for ordinal variables , for test-retest reliability averaged 0.86 , 0.90 , 0.80 , and 0.74 for HRQL , lifetime health , recent health , and exercise variables , respectively .


Correlation coefficients , again ICCs and , for parallel-form reliability ( ie , equivalence ) between paper and electronic versions averaged 0.90 , 0.85 , 0.85 , and 0.81 for HRQL , lifetime health , recent health , and exercise variables , respectively .


Typical measurement error was less than the a priori thresholds of clinical interest , and we found minimal evidence of systematic test-retest error .


We found strong evidence of content validity , convergent construct validity with the Short-Form 12 Version 2 HRQL instrument , and feasibility of administration in an elite , competitive athletic population .


These data suggest that the TLC Health Survey is a valid and reliable instrument for assessing lifetime and recent health , exercise , and HRQL , among elite competitive athletes .


Generalizability of the instrument may be enhanced by additional , larger-scale studies in diverse populations .


Physical therapy has not been evaluated much for the treatment of chronic venous insufficiency before .


The question is whether balneohydrotherapy and usual care combined is superior to usual care alone .


In a randomized trial comparing spa therapy versus waiting list patients were treated on an out-patient basis in a private spa center .


Patients had to be between 18 and 80 years old , with chronic venous insufficiency ( stage 3 or 4 according to the CEAP classification ) .


The balneohydrotherapy group received 18 days of treatment in Aix-Les-Bains spa center continuing their usual care .


The control group continued their usual care as well during the study .


The balneohydrotherapy program consisted of Kneipp therapy ( 10 minutes ) , walking 10 minutes in a special mineral water pool with underwater jets at 23 C , massage and bathing in a mineral water tub at 34 C.


The main outcome criterion was the number of patients with 20 % self assessed improvement on the Chronic Venous Insufficiency Questionnaire at three months after therapy .


192 patients were assessed for eligibility , 99 were randomized 5 retired drew back their consent and were not included in the intention to treat analysis .


None were lost to follow up .


After three months 32 ( 66 % ) patients improved in the balneohydrotherapy group and 13 ( 28 % ) in the control group .


The difference between groups was significant ( odd ratio 5.08 [ 1.94 - 13.55 ] , relative risk reduction 2.33 [ 1.42 - 3.84 ] ) .


There were no serious side effects .


Balneohydrotherapy seems to improve quality of life of patients with chronic venous insufficiency .


To determine the efficacy of prostaglandin administration during the proliferative phase in order to improve pregnancy rates following frozen embryo transfer during a hormone replacement cycle ( HRC ) .


From September 2010 through March 2012 , patients ( n = 135 ) were recruited who had undergone oocyte retrieval during a stimulation cycle with clomiphene and had deferred fresh embryo transfer ( ET ) due to a thin uterine endometrium .


All patients were less than 40 years of age and underwent thawed ET following all embryo cryopreservation , and were randomly divided into two groups for thawed ET using a conventional hormone replacement cycle with or without prostaglandin derivatives ( prostaglandin or conventional group ) .


Prostaglandin derivatives were administrated during the proliferative phase .


Pregnancy and implantation rates following frozen ET were compared between the two groups .


Although the endometrial thickness on the day of ET was similar for the prostaglandin and conventional groups , the pregnancy and implantation rates for the prostaglandin group were 40.0 % and 22.0 % , respectively , which was significantly higher than the rates for the conventional group ( P < 0.01 ) .


Among patients who avoided fresh ET due to a thin endometrium , the pregnancy rate following a thawed cycle was low .


However , it was improved when prostaglandin derivatives were used during the proliferative phase .


Family-based treatment is an efficacious outpatient intervention for medically stable adolescents with anorexia nervosa .


Previous research suggests family-based treatment may be more effective for some families when parents and adolescents attend separate therapy sessions compared to conjoint sessions .


Our service developed a novel separated model of family-based treatment , parent-focused treatment , and is undertaking a randomised controlled trial to compare parent-focused treatment to conjoint family-based treatment .


This randomised controlled trial will recruit 100 adolescents aged 12-18 years with DSM-IV anorexia nervosa or eating disorder not otherwise specified ( anorexia nervosa type ) .


The trial commenced in 2010 and is expected to be completed in 2015 .


Participants are recruited from the Royal Children 's Hospital Eating Disorders Program , Melbourne , Australia .


Following a multidisciplinary intake assessment , eligible families who provide written informed consent are randomly allocated to either parent-focused treatment or conjoint family-based treatment .


In parent-focused treatment , the adolescent sees a clinical nurse consultant and the parents see a trained mental health clinician .


In conjoint family-based treatment , the whole family attends sessions with the mental health clinician .


Both groups receive 18 treatment sessions over 6 months and regular medical monitoring by a paediatrician .


The primary outcome is remission at end of treatment and 6 and 12 month follow up , with remission defined as being 95 % expected body weight and having an eating disorder symptom score within one standard deviation of community norms .


The secondary outcomes include partial remission and changes in eating pathology , depressive symptoms and self-esteem .


Moderating and mediating factors will also be explored .


This will be first randomised controlled trial of a parent-focused model of family-based treatment of adolescent anorexia nervosa .


If found to be efficacious , parent-focused treatment will offer an alternative approach for clinicians who treat adolescents with anorexia nervosa .


Australian and New Zealand Clinical Trials Registry ACTRN12610000216011 .


Restoring patient homeostasis after coronary angiography , the gold standard diagnostic test for coronary heart disease is usually achieved by manual compression of the puncture site using a sandbag and prolonged bed rest .


However , this process frequently results in patient complaints of back pain and discomfort .


The aim of study was to assess the effect of positioning on patient outcomes after coronary angiography .


This study used a single-blind randomized control trial approach .


The sample consisted of 80 patients who had undergone a nonemergency coronary angiography via the femoral artery .


Balanced block randomization was used to allocate participants into intervention and control groups .


Routine care for the intervention group ( n = 40 ) was adjusted to include the following : ( 1 ) intermittent changes to patient body and head position in bed during first 6 hours after catheterization , ( 2 ) reduction of sandbag compression time on the puncture site to 1 hour , and ( 3 ) regular examination for bleeding during the first 6 hours after catheterization .


Intervention group participants were allowed to ambulate without restriction 6 hours after catheterization .


Patients in the control group ( n = 40 ) received routine care , consisting of ( 1 ) 6-24 hours of bed rest in the supine position with the affected leg fixed straight and immobilized and ( 2 ) sandbag compression on the puncture site for 6 hours .


The main outcomes used in this study were level of back pain , discomfort , foot pain , bleeding , and hematoma .


Intervention group patients had significantly less back pain and foot pain and higher comfort than the control group at the second , third , and sixth hour after catheterization ( p = .00 ) .


There was no significant difference between the two groups in terms of amount of bleeding and hematoma ( p > .05 ) .


Findings suggest that changes in patient position may be safer in the early period of postcatheterization bed rest than currently indicated in standard practice protocols .


Furthermore , limiting sandbag compression to 1 hour has no measurable effect on the incidence and severity of vascular complications .


The treatment of idiopathic nephrotic syndrome is still not well settled and at times is very frustrating .


Number of protocols have been reported with variable results outcome in various conditions .


The main pillar of treatment of idiopathic nephrotic syndrome is use of immunomodulating and suppressive drugs in various combinations .


The herbal preparations have also been reported to have immunomodulating property .


The study has been planned to record Immunomodulating and antiproteinuric effect of Hippophae rhamnoides .


In the present study had 2 groups having 28 patients of idiopathic nephrotic syndrome in each group have been included .


The patients were subjected to haematological , biochemical , immunological investigation at 0 , 1 , 2 and 3 months interval with dietic advise .


Group A have been put on standard treatment , whereas group B on Badriphal in the well worked up doses .


The hydroalcoholic extract of 350 mg twice daily of Badriphal was given to group B as add on treatment .


Patients were followed up with definite protocol at monthly interval for 3 months .


At the end of 3 month patients showed improvement in the symptoms of oedema , anorexia , oliguria in the herbal group .


The urinary estimation of protein showed significant decrease in Group B with elevation of S. albumin levels .


The inflammatory cytokines has showed significant decrease at the end of 3 month .


Thus the pilot study showed beneficial effect of the herbal preparation Hippophae rhamnoides as add on treatment .


A large perspective study is recommended to establish these findings .


This study was performed to assess the effects of vitamin D and calcium supplementation on the metabolic profiles of vitamin D insufficient persons with type 2 diabetes .


In a parallel designed randomised placebo-controlled clinical trial , a total of 118 non-smoker individuals with type 2 diabetes and insufficient 25-hydroxyvitamin D , aged > 30 years , were recruited from the Isfahan Endocrine and Metabolism Research Centre .


Participants were randomly assigned to four groups receiving : ( 1 ) 50,000 U/week vitamin D + calcium placebo ; ( 2 ) 1,000 mg/day calcium + vitamin D placebo ; ( 3 ) 50,000 U/week vitamin D + 1,000 mg/day calcium ; or ( 4 ) vitamin D placebo + calcium placebo for 8 weeks .


A study technician carried out the random allocations using a random numbers table .


All investigators , participants and laboratory technicians were blinded to the random assignments .


All participants provided 3 days of dietary records and 3 days of physical activity records throughout the intervention .


Blood samples were taken to quantify glycaemic and lipid profiles at study baseline and after 8 weeks of intervention .


30 participants were randomised in each group .


During the intervention , one participant from the calcium group and one from the vitamin D group were excluded because of personal problems .


Calcium-vitamin D co-supplementation resulted in reduced serum insulin ( changes from baseline : -14.8 3.9 pmol/l , p = 0.01 ) , HbA1c [ -0.70 0.19 % ( -8.0 0.4 mmol/mol ) , p = 0.02 ] , HOMA-IR ( -0.46 0.20 , p = 0.001 ) , LDL-cholesterol ( -10.36 0.10 mmol/l , p = 0.04 ) and total/HDL-cholesterol levels ( -0.91 0.16 , p = 0.03 ) compared with other groups .


We found a significant increase in QUICKI ( 0.025 0.01 , p = 0.004 ) , HOMA of beta cell function ( HOMA-B ; 11.8 12.17 , p = 0.001 ) and HDL-cholesterol ( 0.46 0.05 mmol/l , p = 0.03 ) in the calcium-vitamin D group compared with others .


Joint calcium and vitamin D supplementation might improve the glycaemic status and lipid profiles of vitamin D insufficient people with type 2 diabetes .


ClinicalTrials.gov NCT01662193 FUNDING : Clinical Research Council , Isfahan University of Medical Sciences , Isfahan , Iran .


Various genetic polymorphisms have been reported to be associated with antipsychotic-induced weight gain .


In this study , we aimed to determine whether risk polymorphisms in 12 candidate genes are associated with reduction in body mass index ( BMI ) of patients following switching of antipsychotics to aripiprazole or ziprasidone .


We recruited 115 schizophrenia patients with metabolic abnormalities and who have been on at least 1year treatment with other antipsychotics ; they were then switched to either aripiprazole or ziprasidone .


They were genotyped , and their BMI monitored for 6 months .


Significant associations with reduction in BMI at 6months following switching were found in two of these genes : with rs1800544 of the ADRA2A gene ( CC+CG [ -0.321.41 kg/m ] vs GG [ -1.041.63 kg/m ] , p = 0.013 ) and with rs1801131 of the MTHFR gene ( AA [ -0.361.53 ] vs AC+CC [ -1.071.53 ] , p = 0.015 ) .


The study data indicated that carriage of the ADRA2A rs1800544 GG genotype and the MTHFR rs1801131 C allele are associated with BMI reduction in this population following switching of antipsychotics to aripiprazole and ziprasidone .


Total hip replacement provides pain relief and improves physical function and quality of life in patients with end-stage hip osteoarthritis .


The incidence of hip replacement operations is expected to increase due to the growing elderly population .


Overall , the posterior approach and lateral approach are the two most commonly used approaches for hip replacement operations .


The posterior approach is associated with an increased risk of revision due to dislocations , and some studies have shown that the lateral approach is associated with reduced patient-reported outcomes , including physical function and pain ; however , this has not been investigated in a randomised controlled trial with a twelve-month follow-up .


We hypothesized that the lateral approach has an inferior outcome in patient-reported outcome compared with the posterior approach after one year .


The trial is a prospective , double blinded , parallel-group controlled trial with balanced randomisation [ 1 : 1 ] .


Patients with hip osteoarthritis scheduled for hip replacement surgery , aged 45-70 years , will be consecutively recruited and randomised into two groups .


Group A will receive hip replacement using the posterior approach , and Group B will receive hip replacement using the lateral approach .


The primary end-point for assessing the outcome of the two interventions will be twelve months after surgery .


Follow-up will also be performed after three and six months .


The primary outcome is Hip Disability and Osteoarthritis Outcome Score , subscale of `` Physical function Short form '' ( HOOS-PS ) Secondary outcome measures include two other subscales of HOOS ( `` Pain '' and `` Hip related Quality of Life '' ) , physical activity level ( UCLA activity score ) , limping ( HHS ) and general health status ( EQ-5D-3L ) .


Explorative outcomes include physical function test , 3D-gait-analysis and muscle strength .


To our knowledge , this is the first randomised controlled trial comparing the posterior approach with the lateral approach with patient reported outcome as the primary outcome and with a twelve-month follow-up .


Clinicaltrial.gov : NCT01616667 .


This study tests the effectiveness of motivational interviewing compared with the usual care for Chinese hypertensive patients .


A randomised controlled trial was used .


One hundred and twenty eligible participants were randomly assigned to either the control group ( usual care group ) or the intervention group ( motivational interviewing group ) .


The results of this study demonstrated that the total scores and the mean scores for each dimension of the adherence questionnaire were increased in the intervention group ( P < 0.05 ) , and the systolic blood pressure and diastolic blood pressure of the hypertensive patients greatly decreased in the intervention group during the six months of the motivational interviewing counselling ( P < 0.05 ) .


The application of motivational interviewing for hypertensive patients is a promising approach for sustaining the clinical benefits of adherence behaviour .


Motivational interviewing should be provided to hypertensive patients at hospitals and community health centres to assist patients in controlling their BP and to enhance treatment adherence .


A series of training courses on the motivational interviewing technique should be provided to nurses .


Ataluren was developed to restore functional protein production in genetic disorders caused by nonsense mutations , which are the cause of cystic fibrosis in 10 % of patients .


This trial was designed to assess the efficacy and safety of ataluren in patients with nonsense-mutation cystic fibrosis .


This randomised , double-blind , placebo-controlled , phase 3 study enrolled patients from 36 sites in 11 countries in North America and Europe .


Eligible patients with nonsense-mutation cystic fibrosis ( aged 6 years ; abnormal nasal potential difference ; sweat chloride > 40 mmol/L ; forced expiratory volume in 1 s [ FEV1 ] 40 % and 90 % ) were randomly assigned by interactive response technology to receive oral ataluren ( 10 mg/kg in morning , 10 mg/kg midday , and 20 mg/kg in evening ) or matching placebo for 48 weeks .


Randomisation used a block size of four , stratified by age , chronic inhaled antibiotic use , and percent-predicted FEV1 .


The primary endpoint was relative change in percent-predicted FEV1 from baseline to week 48 , analysed in all patients with a post-baseline spirometry measurement .


This study is registered with ClinicalTrials.gov , number NCT00803205 .


Between Sept 8 , 2009 , and Nov 30 , 2010 , 238 patients were randomly assigned , of whom 116 in each treatment group had a valid post-baseline spirometry measurement .


Relative change from baseline in percent-predicted FEV1 did not differ significantly between ataluren and placebo at week 48 ( -2.5 % vs -5.5 % ; difference 3.0 % [ 95 % CI -0.8 to 6.3 ] ; p = 0.12 ) .


The number of pulmonary exacerbations did not differ significantly between treatment groups ( rate ratio 0.77 [ 95 % CI 0.57-1 .05 ] ; p = 0.0992 ) .


However , post-hoc analysis of the subgroup of patients not using chronic inhaled tobramycin showed a 5.7 % difference ( 95 % CI 1.5-10 .1 ) in relative change from baseline in percent-predicted FEV1 between the ataluren and placebo groups at week 48 ( -0.7 % [ -4.0 to 2.1 ] vs -6.4 % [ -9.8 to -3.7 ] ; nominal p = 0.0082 ) , and fewer pulmonary exacerbations in the ataluern group ( 1.42 events [ 0.9-1 .9 ] vs 2.18 events [ 1.6-2 .7 ] ; rate ratio 0.60 [ 0.42-0 .86 ] ; nominal p = 0.0061 ) .


Safety profiles were generally similar for ataluren and placebo , except for the occurrence of increased creatinine concentrations ( ie , acute kidney injury ) , which occurred in 18 ( 15 % ) of 118 patients in the ataluren group compared with one ( < 1 % ) of 120 patients in the placebo group .


No life-threatening adverse events or deaths were reported in either group .


Although ataluren did not improve lung function in the overall population of nonsense-mutation cystic fibrosis patients who received this treatment , it might be beneficial for patients not taking chronic inhaled tobramycin .


PTC Therapeutics , Cystic Fibrosis Foundation , US Food and Drug Administration 's Office of Orphan Products Development , and the National Institutes of Health .


Treatment of idiopathic headshaking in horses is complicated by an incomplete understanding of underlying pathophysiology and partially effective treatments .


If an inflammatory etiology exists , corticosteroids could be beneficial .


An anti-inflammatory dose of dexamethasone reduces the signs of idiopathic headshaking in a field setting .


Convenience sample of 20 adult horses with idiopathic headshaking syndrome .


Cases were recruited from the general population and diagnosed by attending veterinarians .


Prospective , blinded clinical trial .


Pulsed dosing was with oral dexamethasone ( 60 mg PO Q24h 4 days , q3 weeks for 4 months ) or placebo ( inert paste ) .


Owners were blinded and asked to score the headshaking from 0 to 4 ( 4 = most severe ) 3 days per week .


The change in headshaking scores ( HS ) over each treatment pulse was compared between groups by ordinal logistic regression .


Twelve horses completed the trial .


There was no significant difference between treated or placebo horses ( P = .987 ) .


Sun ( P .001 ) , wind ( P = .028 ) , and exercise ( P .045 ) significantly increased HS .


No benefit of dexamethasone treatment was detected for idiopathic headshaking .


The results confirmed previous reports of common triggers for headshaking behavior


Stenosis of the internal carotid artery has been associated with cognitive impairment and decline .


However , studies testing the effect of carotid revascularisation on cognition have had conflicting results .


This may in part be explained by variation in the flow territory of the carotid artery .


In 12 to 36 % of the patients , the posterior cerebral artery is mainly or exclusively supplied by the internal carotid artery via a foetal-type posterior cerebral artery .


In these patients , ipsilateral carotid artery stenosis is likely to result in a larger area with hypoperfusion than in case of a normal posterior cerebral artery .


Patients with a foetal-type posterior cerebral artery could therefore benefit more from revascularisation .


We compared the effects of carotid revascularisation on cognition between patients with a foetal-type and those with a normal posterior cerebral artery .


Patients with symptomatic internal carotid artery stenosis50 % , enrolled in the International Carotid Stenting Study ( ICSS ) at a single centre , underwent detailed neuropsychological examinations before and 6 months after revascularisation .


Cognitive test results were standardized into z-scores , from which a cognitive sumscore was calculated .


The primary outcome was the change in cognitive sumscore between baseline and follow-up .


Changes in cognitive sumscore were compared between patients with an ipsilateral foetal-type and those with a normal posterior cerebral artery , as assessed with CT or MR angiography .


Of 145 patients enrolled in ICSS at the centre during the study period , 98 had both angiography at baseline and neuropsychological examination at baseline and at 6-months follow-up .


The cognitive sum score decreased by 0.28 ( 95 % confidence interval , 0.10 to 0.45 ) in 13 patients with an ipsilateral foetal-type posterior cerebral artery and by 0.07 ( 95 % CI , 0.002 to 0.15 ) in 85 patients with a normal posterior cerebral artery ( mean difference , -0.20 ; 95 % CI , -0.40 to -0.01 ) .


This did not change essentially after adjustment for baseline factors .


An ipsilateral foetal-type posterior cerebral artery appears to increase cognitive decline after carotid revascularisation .


Our findings have to be reproduced in an independent study before further implications can be made .


Outpatient nonhospice palliative care has been shown to provide many benefits to patients facing advanced illness , but such services remain uncommon in the U.S. Little is known about the association between clinic-based outpatient palliative care consultation and the timing of hospice enrollment .


To determine whether there are differences in hospice length of service ( LOS ) between patients who were seen vs. patients who were not seen in an outpatient palliative care clinic before enrollment in hospice .


Using a retrospective study of medical records , a `` prior palliative care clinic '' group was formed of those hospice patients who had had a nonhospice clinic-based outpatient palliative care consult before hospice admission ( n = 354 ) .


For those patients , `` control '' hospice patients without prior clinic-based palliative care were chosen who were matched by age , gender , median income of their zip code , and diagnostic group .


Both groups were restricted to patients who died while enrolled in hospice .


LOS for these two groups was compared using standard statistical methods of survival analysis .


Prior palliative care clinic patients had a median LOS of 24 days , whereas control patients had a median LOS of 15 days ( 95 % CI for difference between the medians 5-13 days ) .


The difference between the LOS distribution curves was statistically significant by the log-rank test ( P < 0.001 ) .


Hospice patients who had clinic-based outpatient palliative consults before hospice enrollment tended , on average , to have a longer LOS in hospice than patients who did not .


This study evaluated the effects of aclidinium bromide , a long-acting muscarinic antagonist indicated for maintenance treatment of chronic obstructive pulmonary disease ( COPD ) , on exercise endurance , dyspnea , lung hyperinflation , and physical activity .


In this randomized , double-blind , crossover study , patients with stable COPD and moderate-to-severe airflow limitation received aclidinium 400 g twice daily or placebo via Genuair/Pressair ( a ) for 3 weeks ( 2-week washout between treatment periods ) .


The primary endpoint was change from baseline to Week 3 in endurance time , measured by constant work rate cycle ergometry testing at 75 % peak incremental work rate .


Changes from baseline in intensity of exertional dyspnea ( Borg CR10 Scale ) and trough inspiratory capacity were secondary endpoints .


Additional endpoints included changes from baseline in other spirometric , plethysmographic , and physical activity ( assessed by objective accelerometer measurement ) parameters .


Efficacy endpoints were analyzed using an analysis of covariance model .


In total , 112 patients were randomized and treated ( mean age 60.3 years ; mean post-bronchodilator forced expiratory volume in 1 s 1.7 L [ 56.7 % predicted ] ; mean endurance time 485.7 s ) .


After 3 weeks , endurance time was significantly increased with aclidinium versus placebo ( treatment difference 58.5 s ; p < 0.05 ) .


At Week 3 , aclidinium significantly reduced dyspnea intensity at isotime during exercise ( treatment difference -0.63 ; p < 0.05 ) and improved trough inspiratory capacity ( treatment difference 78 mL ; p < 0.05 ) versus placebo .


Significant improvements in spirometric , plethysmographic , and some physical activity parameters were observed with aclidinium versus placebo .


These results suggest that aclidinium significantly improves exercise endurance , exertional dyspnea , hyperinflation , and physical activity in patients with COPD .


ClinicalTrials.gov identifier : NCT01471171 ; URL : http://www.clinicaltrials.gov .


Canagliflozin is a sodium glucose co-transporter 2 inhibitor approved for treating patients with type 2 diabetes .


This study evaluated renal and non-renal effects of canagliflozin on postprandial plasma glucose ( PG ) excursion in patients with type 2 diabetes inadequately controlled with metformin .


Patients ( N = 37 ) were randomized to a four-period crossover study with 3-day inpatient stays in each period and 2-week wash-outs between periods .


Patients received Treatments ( A ) placebo/placebo , ( B ) canagliflozin 300 mg/placebo , ( C ) canagliflozin 300 mg/canagliflozin 300 mg , or ( D ) canagliflozin 300 mg/canagliflozin 150 mg on Day 2/Day 3 in one of four treatment sequences ( similar urinary glucose excretion [ UGE ] expected for Treatments B-D ) .


A mixed-meal tolerance test ( MMTT ) was given 20 minutes post-dose on Day 3 of each period .


A single dose of canagliflozin 300 mg reduced both fasting and postprandial PG compared with placebo , with generally similar effects on fasting PG and UGE observed for Treatments B-D .


An additional dose of canagliflozin 300 mg ( Treatment C ) , but not 150 mg ( Treatment D ) , prior to the MMTT on Day 3 provided greater postprandial PG reduction versus placebo ( difference in incremental glucose AUC0-2h , -7.5 % for B vs A ; -18.5 % for C vs A ; -12.0 % [ P = 0.012 ] for C vs B ) , leading to modestly greater reductions in total glucose AUC0-2h with Treatment C versus Treatment B or D. Canagliflozin was generally well tolerated .


These findings suggest that a non-renal mechanism ( ie , beyond UGE ) contributes to glucose lowering for canagliflozin 300 mg , but not 150 mg .


This study aimed to explore the effects of massage on the state anxiety of patients receiving percutaneous coronary intervention ( PCI ) .


In accordance with the principle of the minimum allocation of imbalance index for comparability , a total of 117 cases that were ready to receive PCI were divided into two groups ( 59 in the intervention group and 58 in the control group ) .


The patients in the control group received routine care , whereas the patients in the observation group were given massage intervention .


The state anxiety , heart rate , and blood pressure of the two groups were observed and compared .


Massage treatments reduced the emergency response and level of anxiety of cardiovascular patients before PCI .


The post-intervention blood pressure , heart rate , and pain score of the intervention group were significantly better than those of the control group ( P < 0.05 ) .


Health professionals should pay attention to and strengthen the exploration of the effects of reasonable care intervention mode under PCI to promote the physical and mental health of patients , as well as improve their medical care satisfaction .


A substantial proportion of patients with Parkinson 's disease ( PD ) have concomitant cognitive dysfunction .


Identification of biomarker profiles that predict which PD patients have a greater likelihood for progression of cognitive symptoms is pressingly needed for future treatment and prevention approaches .


Subjects were drawn from the Deprenyl and Tocopherol Antioxidative Therapy of Parkinsonism ( DATATOP ) study , a large clinical trial that enrolled initially untreated PD patients .


For the current study , Phase One encompassed trial baseline until just prior to levodopa administration ( n = 403 ) , and Phase Two spanned the initiation of levodopa treatment until the end of cognitive follow-up ( n = 305 ) .


Correlations and linear mixed models were performed to determine cross-sectional and longitudinal associations between baseline amyloid 1-42 ( A42 ) , total tau ( t-tau ) , and phosphorylated tau ( p-tau ) in cerebrospinal fluid ( CSF ) and measures of memory and executive function .


Analyses also considered APOE genotype and tremor - vs. rigidity-dominant phenotype .


No association was found between baseline CSF biomarkers and cognitive test performance during Phase One .


However , once levodopa treatment was initiated , higher p-tau and p-tau/A42 predicted subsequent decline on cognitive tasks involving both memory and executive functions .


The interactions between biomarkers and cognition decline did not appear to be influenced by levodopa dosage , APOE genotype or motor phenotype .


The current study has , for the first time , demonstrated the possible involvement of tau species , whose gene ( MAPT ) has been consistently linked to the risk of PD by genome-wide association studies , in the progression of cognitive symptoms in PD .


The objective of this study was to determine whether a mindfulness program , created for the workplace , was both practical and efficacious in decreasing employee stress while enhancing resiliency and well-being .


Participants ( 89 ) recruited from The Dow Chemical Company were selected and randomly assigned to an online mindfulness intervention ( n = 44 ) or wait-list control ( n = 45 ) .


Participants completed the Perceived Stress Scale , the Five Facets of Mindfulness Questionnaire , the Connor-Davidson Resiliency Scale , and the Shirom Vigor Scale at pre - and postintervention and 6-month follow-up .


The results indicated that the mindfulness intervention group had significant decreases in perceived stress as well as increased mindfulness , resiliency , and vigor .


This online mindfulness intervention seems to be both practical and effective in decreasing employee stress , while improving resiliency , vigor , and work engagement , thereby enhancing overall employee well-being .


The 47 integrin monoclonal antibody vedolizumab is hypothesised to be gut selective .


Effects of vedolizumab on immune responses to parenterally or enterally administered antigens were investigated .


In this randomised , double-blind , placebo-controlled , phase I trial , healthy participants received a single intravenous dose of vedolizumab 750mg ( n = 64 ) or placebo ( n = 63 ) .


After 4days , participants began intramuscular hepatitis B vaccine ( HBV ; days 4 , 32 , 60 ) and oral cholera vaccine ( OCV ; days 4 , 18 ) regimens .


The study was designed to demonstrate a 15 % non-inferiority margin for the between-group difference in the primary end point : percentage of participants with HBV seroconversion at day 74 ( serum hepatitis B surface antigen ( HBs ) antibody titre 10IU/L ) .


OCV seroconversion at day 74 ( > 4-fold increase in serum cholera toxin ( CT ) antibodies ) was a secondary end point .


A total of 56 ( 90.3 % ) placebo-treated and 54 ( 88.5 % ) vedolizumab-treated participants responded to HBV .


Geometric mean anti-HBs titres were similar for placebo ( 114.4 IU/L ) and vedolizumab ( 129.6 IU/L ) at day 74 .


A total of 60 ( 96.8 % ) placebo-treated and 52 ( 82.5 % ) vedolizumab-treated participants responded to OCV at day 74 .


Geometric mean anti-CT IgG levels were higher for placebo than for vedolizumab at day 74 ( 9210.08 vs. 3007.8 ELISA Units ( EU ) / mL ) and day 32 ( 11629.3 vs. 1575.4 EU/mL ) .


Anti-CT IgA results were similar .


Adverse events were consistent with previous experience .


One serious adverse event ( spontaneous abortion ) was reported for placebo .


Vedolizumab did not alter the response to parenterally administered antigens but reduced the response to oral antigens , demonstrating its gut-selective mechanism of action .


NCT Number : 01981616 ; EudraCT Number : 2011-001874-24 .


In a Japanese Phase II study , the hepatitis C virus NS3/4A protease inhibitor simeprevir demonstrated potent antiviral activity and significantly improved sustained virologic response rates when added to peginterferon -2 a/ribavirin in treatment-nave patients infected with hepatitis C virus genotype 1 .


CONCERTO-1 was a Phase III , randomized , double-blind , placebo-controlled trial .


Treatment-nave adults ( 70 years ) with chronic hepatitis C virus genotype 1 infection ( hepatitis C virus RNA 5 log10 IU/ml ) were randomized ( 2:1 ) to simeprevir 100mg once-daily with peginterferon -2 a/ribavirin for 12 weeks then response-guided therapy with peginterferon -2 a/ribavirin for 12 or 36 weeks , or to placebo with peginterferon -2 a/ribavirin for 12 weeks then peginterferon -2 a/ribavirin for 36 weeks .


Overall , 183 patients were treated .


Sustained virologic response 12 weeks after treatment end ( primary efficacy endpoint ) was achieved in 88.6 % of simeprevir - and 61.7 % of placebo-treated patients ( p < 0.0001 for stratum-adjusted between-group difference ) .


Overall , 91.9 % of simeprevir-treated patients met response-guided therapy criteria and completed treatment at week 24 ; sustained virologic response rate at 12 weeks in these patients was 92.0 % .


One simeprevir - ( 0.8 % ) and two placebo-treated patients ( 3.3 % ) experienced viral breakthrough ; respective viral relapse rates were 7.6 % and 30.6 % .


Overall adverse event profile in simeprevir-treated patients was comparable to that in patients who received peginterferon -2 a/ribavirin alone .


Simeprevir once daily with peginterferon -2 a/ribavirin significantly improved sustained virologic response rate 12 weeks after treatment end in treatment-nave patients with chronic hepatitis C virus genotype 1 infection , with a shorter 24-week treatment duration in most patients .


The treatment of bipolar disorder type I ( BD-I ) with a comorbid cocaine dependence disorder ( CDD ) is a challenge in current psychiatric practice .


Drugs with proven efficacy in manic/mixed episodes , such as atypical antipsychotics and mood stabilizers , sometimes do not prevent depressive relapses ; on the other hand , the use of antidepressants during acute depressive episodes may increase the risk of a manic switch .


The aim of the present study was to investigate the short-term efficacy of bupropion augmentation in acutely depressed BD-I patients with co-occurring CDD .


Twelve depressed BD-I patients , with a comorbid CDD , treated with valproate 1000 to 1500 mg/d and aripiprazole 10 mg/d , were randomly assigned to receive bupropion 150 mg/d as an open-label add-on therapy ( n = 5 ) or to continue their previous treatment ( n = 7 ) .


After 4 weeks of observation , patients receiving add-on therapy with bupropion have improved in terms of Hamilton Depression Rating Scale scores and Drug Abuse Screening Test scores , with respect to those of the comparison group , whereas no significant increase of Young Mania Rating Scale scores over time was observed .


Our preliminary findings suggest that combining bupropion with mood stabilizers and atypical antipsychotics may be a good therapeutic option in short-term treatment of depressed BD-I patients with comorbid CDD .


Previous analysis of a single data set in acute pain following third molar extraction demonstrated a strong relationship between the speed of reduction of pain intensity and overall pain relief , as well as need for additional analgesia .


Individual patient data analysis of a single randomized , double-blind trial of placebo , paracetamol 1000 mg , ibuprofen sodium 400 mg and ibuprofen-poloxamer 400 mg following third molar extraction .


Visual analogue scale pain intensity ( VASPI ) and other measurements were made at baseline , every 5-45 min , and at 60 , 90 , 120 , 180 , 240 , 300 and 360 min .


Most patients produced consistent VASPI results over time .


For placebo and paracetamol , few patients achieved low VASPI scores and maintained them .


For both ibuprofen formulations , VASPI scores fell rapidly during the first hour and were then typically maintained until later re-medication .


Analysis of all patients showed that rapid VASPI reduction in the first hour was strongly correlated with good overall pain relief ( high total pain relief over 0-6 h ) , and with lesser need for additional analgesia within 6 h. Results for this analysis were in very good agreement with a previous analysis , validating the relationship between fast initial pain intensity reduction and overall good pain relief in this setting .


In acute pain following third molar extraction , faster acting analgesic formulations provide earlier onset of pain relief , better overall pain relief and a less frequent need for additional analgesia , indicating longer lasting pain relief .


To determine the effects of subanesthetic ketamine in dogs with pyometra on C-reactive protein ( CRP ) concentrations following surgery .


Prospective , nonconcealed , alternating allocation controlled trial .


Veterinary teaching hospital .


Sixteen dogs diagnosed with pyometra .


The tentative diagnosis of canine pyometra was based on compatible history , physical examination findings , ultrasonographic findings , and hematological evaluation .


Two different anesthesia and analgesic protocols with and without low-dose ketamine were used during and following ovariohysterectomy in 16 female dogs ( n = 8 per group ) that were diagnosed with naturally occurring pyometra .


Dogs were sequentially allocated to treatment groups in an alternating fashion without concealment .


Serum was collected before , 24 , and 48 hours after surgery for CRP measurement .


Perioperative physical parameters in the 2 groups of dogs were similar .


The serum concentrations of CRP in both groups were essentially the same before surgery , but significantly increased in the control group and decreased in ketamine group at 48 hours after surgery .


Low-dose ketamine attenuated the postoperative concentration of serum CRP in dogs with pyometra compared with dogs that did not receive ketamine in the perioperative period .


Further studies are warranted to determine the clinical implications of these findings .


In the United States certain minority groups , such as racial/ethnic immigrant women , are less likely than non-Hispanic White women to be screened for cervical cancer .


Barriers to such care include health insurance , cost , knowledge , attitudes , health literacy , and cultural norms and practices .


Among the most promising approaches to increase screening in these groups are patient navigators that can link women to sources of appropriate care .


Another recent promising approach is using human papilloma virus ( HPV ) self-sampling .


In this manuscript , we describe our National Cancer Institute-sponsored study testing such approaches among immigrant minority women .


The South Florida Center for the Reduction of Cancer Health Disparities ( SUCCESS ) is conducting a three-arm randomized trial among Hispanic , Haitian , and African American women in Miami-Dade County .


Community health workers ( CHW ) based in each of three communities are recruiting 200 women at each site ( 600 total ) .


Eligibility criteria include women aged 30-65 years who have not had a Pap smear test in the last 3years .


Prior to randomization , all women undergo a standardized structured interview .


Women randomized to public health outreach , Group 1 , receive culturally tailored educational materials .


Women in Group 2 receive an individualized comprehensive cervical cancer CHW-led education session followed by patient navigation to obtain the Pap smear test at community-based facilities .


Women in Group 3 have the option of navigation to a Pap smear test or performing HPV self-sampling .


The primary outcome is self-report of completed screening through a Pap smear test or HPV self-sampling within 6months after enrollment .


SUCCESS is one of the first trials testing HPV self-sampling as a screening strategy among underserved minority women .


If successful , HPV self-sampling may be an important option in community outreach programs aimed at reducing disparities in cervical cancer .


Clinical Trials.gov # NCT02121548 , registered April 21 , 2014 .


To compare postoperative pain scores and assess efficacy between an adjustable single-incision sling and a standard transobturator sling for stress urinary incontinence ( SUI ) .


This single-blinded randomized controlled trial involved 156 women with clinically proven SUI .


Women were allocated to receive either an adjustable single-incision or a transobturator sling .


The primary outcome was postoperative pain score on a visual analog scale .


Secondary outcomes were objective and subjective cure rates at 12 months , symptom bother scores , quality of life , and complications .


The mean pain score in the first week postoperatively was significantly lower at all time points in the adjustable single-incision sling group compared with the transobturator sling group .


Maximum difference in pain score was reported on the evening of the day of surgery ; median pain score was 1.0 ( interquartile range 2.0 ) in the adjustable sling group and 3.0 ( interquartile range 4.5 ) in the transobturator sling group ( Mann Whitney U test P < .001 ) .


There was no statistical difference in analgesic use .


The objective cure rates in the adjustable single-incision sling and in the transobturator sling group were 90.8 % and 88.6 % ( P = .760 ) , and the subjective cure rates were 77.2 % and 72.9 % ( P = .577 ) , respectively .


No difference in the complication rate was found .


An adjustable single-incision sling for the treatment of SUI is associated with lower early postoperative pain scores but shows comparable cure rates with a transobturator at 12 months of follow-up .


Netherlands Trial Register , http://www.trialregister.nl , NTR : 2558 .


I.


To investigate the preventive effect of behavioral therapy plus flunarizine in children with migraine .


Ninety pediatric patients with migraine between January 2011and January 2014 were randomly divided into treatment group ( 45 cases ) and control group ( 45 cases ) .


The treatment group received behavioral therapy in addition to oral flunarizine , while the control group received oral flunarizine alone .


All patients were followed up for 3 months to evaluate the therapeutic effect by the Pediatric Migraine Disability Assessment Score ( PedMIDAS ) and improved Bussone headache index .


There were no significant differences in PedMIDAS ( P > 0.05 ) and improved Bussone headache index ( P > 0.05 ) between the control and treatment groups before treatment .


Significant differences were observed in PedMIDAS ( 168 vs 2010 ; P < 0.05 ) and improved Bussone headache index ( 2518 vs 3721 ; P < 0.05 ) between the two groups after 3 months of treatment .


Preventive treatment of behavioral therapy plus oral flunarizine shows a better clinical efficacy than oral flunarizine alone in children with migraine and holds promise for clinical application .


Uncontrolled asthma during pregnancy is associated with maternal and perinatal hazards .


A pharmacist-led intervention directed at improving maternal asthma control , involving multidisciplinary care , education , and regular monitoring to help reduce these risks , was developed and evaluated .


A randomized controlled trial was carried out in the antenatal clinics of two major Australian maternity hospitals .


Sixty pregnant women < 20 weeks gestation who had used asthma medications in the previous year were recruited .


Participants were randomized to either an intervention or a usual care group and followed prospectively throughout pregnancy .


The primary outcome was Asthma Control Questionnaire ( ACQ ) score .


Mean changes in ACQ scores from baseline were compared between groups at 3 and 6 months to evaluate intervention efficacy .


The ACQ score in the intervention group ( n = 29 ) decreased by a mean SD of 0.46 1.05 at 3 months and 0.89 0.98 at 6 months .


The control group ( n = 29 ) had a mean decrease of 0.15 0.63 at 3 months and 0.18 0.73 at 6 months .


The difference between groups , adjusting for baseline , was -0.22 ( 95 % CI , -0.54 to 0.10 ) at 3 months and -0.60 ( 95 % CI , -0.85 to -0.36 ) at 6 months .


The difference at 6 months was statistically significant ( P < .001 ) and clinically significant ( > 0.5 ) .


No asthma-related oral corticosteroid use , hospital admissions , emergency visits , or days off from work were reported during the trial .


A multidisciplinary model of care for asthma management involving education and regular monitoring could potentially improve maternal asthma outcomes and be widely implemented in clinical practice .


Australian and New Zealand Clinical Trials Registry ; No. : ACTRN12612000681853 ; URL : www.anzctr.org.au .


Anxiety disorders are among the most prevalent mental disorders and are usually treated with medication and/or psychotherapy .


When anxiety disorders are accompanied with comorbid depression , this further complicates the treatment process .


Medication compliance is a common problem due to adverse side effects and new and effective treatments that have minimal side effects are needed for the treatment of anxiety and depression .


This study used a randomized , double-blind , sham controlled design to examine the effectiveness of CES as a treatment for anxiety disorders and comorbid depression in a primary care setting .


The study was registered at clinicaltrials.gov , NCT01533415 .


One hundred and fifteen participants , age 18 years and over , with a primary diagnosis of an anxiety disorder were enrolled from February 2012 to December 2012 The Hamilton Rating Scale for Anxiety ( HAM-A ) and the Hamilton Depression Rating Scale17 ( HAM-D17 ) were used for baseline and outcome measures at weeks one , three , and five .


Response to treatment was defined as a reduction of 50 % or more on these measures .


Analysis of covariance revealed a significant difference between the active CES group and the sham CES group on anxiety ( p = 0.001 , d = 0.94 ) and on depression ( p = 0.001 , d = 0.78 ) from baseline to endpoint of study in favor of the active CES group .


CES significantly decreases anxiety and comorbid depression .


Subjects reported no adverse events during the study .


Obstructive sleep apnea ( OSA ) has been associated with hypertension , which is one of the intermediary mechanisms leading to increased cardiovascular morbidity .


This study aimed at evaluating the effects of a combination of continuous positive airway pressure ( CPAP ) and telemedicine support on blood pressure ( BP ) reduction in high cardiovascular risk OSA patients .


A multi-center randomized controlled trial that compared standard CPAP care and CPAP care and a telemedicine intervention .


Sleep clinics in France .


107 adult ( 18-65 years old ) OSA patients ( AHI > 15 events/h ) with a high cardiovascular risk ( cardiovascular SCORE > 5 % or secondary prevention ) .


Patients were randomized to either standard care CPAP ( n = 53 ) or CPAP and telemedicine ( n = 54 ) .


Patients assigned to telemedicine were equipped with a smartphone for uploading BP measurements , CPAP adherence , sleepiness , and quality of life data ; in return , they received pictograms containing health-related messages .


The main outcome was home self-measured BP and secondary outcomes were cardiovascular risk evolution , objective physical activity , CPAP adherence , sleepiness and quality of life .


Self-measured BP did not improve in either group ( telemedicine or standard care ) .


Patients in primary prevention showed greater BP reduction with CPAP treatment than those in secondary prevention .


CPAP treatment supported by telemedicine alone did not improve blood pressure and cardiovascular risk in high cardiovascular risk OSA patients .


This study emphasizes the need for diet and physical activity training programs in addition to CPAP when aiming at decreasing cardiometabolic risk factors in these patients .


ClinicalTrials.gov identifier : NCT01226641 .


To provide patient-centred holistic care , doctors must possess good interpersonal and empathic skills .


Medical schools traditionally adopt a skills-based approach to such training but creative engagement with the arts has also been effective .


A novel arts-based approach may help medical students develop empathic understanding of patients and thus contribute to medical students ' transformative process into compassionate doctors .


This study aimed to evaluate the impact of an arts-making workshop on medical student empathy .


This was a mixed-method quantitative-qualitative study .


In the 2011-12 academic year , all 161 third year medical students at the University of Hong Kong were randomly allocated into either an arts-making workshop or a problem-solving workshop during the Family Medicine clerkship according to a centrally-set timetable .


Students in the arts-making workshop wrote a poem , created artwork and completed a reflective essay while students in the conventional workshop problem-solved clinical cases and wrote a case commentary .


All students who agreed to participate in the study completed a measure of empathy for medical students , the Jefferson Scale of Empathy ( JSE ) ( student version ) , at the start and end of the clerkship .


Quantitative data analysis : Paired t-test and repeated measures ANOVA was used to compare the change within and between groups respectively .


Qualitative data analysis : Two researchers independently chose representational narratives based on criteria adapted from art therapy .


The final 20 works were agreed upon by consensus and thematically analysed using a grounded theory approach .


The level of empathy declined in both groups over time , but with no statistically significant differences between groups .


For JSE items relating to emotional influence on medical decision making , participants in the arts-making workshop changed more than those in the problem-solving workshop .


From the qualitative data , students perceived benefits in arts-making , and gained understanding in relation to self , patients , pain and suffering , and the role of the doctor .


Though quantitative findings showed little difference in empathy between groups , arts-making workshop participants gained empathic understanding in four different thematic areas .


This workshop also seemed to promote greater self-awareness which may help medical students recognize the potential for emotions to sway judgment .


Future art workshops should focus on emotional awareness and regulation .


Resistant hypertension ( res-HTN ) is a challenging problem , but little is known of res-HTN in patients with coronary artery disease ( CAD ) .


In this post-hoc INternational VErapamil SR-Trandolapril STudy ( INVEST ) analysis , we assessed prevalence , predictors , and impact on outcomes of res-HTN in CAD patients with hypertension .


Participants ( n = 17190 ) were divided into three groups according to achieved blood pressure ( BP ) : controlled ( BP < 140/90 mmHg on three or fewer drugs ) ; uncontrolled ( BP 40/90 mmHg on two or fewer drugs ) ; or resistant ( BP 40/90 mmHg on three drugs or any patient on at least four drugs ) .


The prevalence of res-HTN was 38 % : significant predictors of res-HTN included heart failure [ odds ratio ( OR ) 1.73 ] , diabetes ( OR 1.63 ) , Black race ( OR 1.50 ) , and US residence ( OR 1.50 ) .


Compared with controlled HTN , res-HTN had multivariate-adjusted association with higher risk of adverse outcomes { first occurrence of all-cause death , nonfatal myocardial infarction , or nonfatal stroke [ hazard ratio 1.27 , 95 % confidence interval ( CI ) 1.13-1 .43 ] , and individual outcomes of all-cause death ( hazard ratio 1.29 , 95 % CI 1.13-1 .48 ) , cardiovascular mortality ( hazard ratio 1.47 , 95 % CI 1.21-1 .78 ) , and nonfatal stroke ( hazard ratio 1.61 , 95 % CI 1.17-2 .22 ) , but not nonfatal myocardial infarction ( hazard ratio 0.98 , 95 % CI 0.72-1 .34 ) } .


Adverse outcomes , except nonfatal stroke , did not differ in patients with res-HTN compared to uncontrolled HTN .


Res-HTN is common in patients with CAD and hypertension , associated with poor prognosis , and linked with a number of conditions .


Emphasis should be placed on recognizing those at risk for res-HTN and future studies should examine whether more aggressive treatment of res-HTN improves outcomes .


There has been no study on the efficacy of lafutidine for patients with reflux esophagitis in Korea .


To evaluate the efficacy of a new-generation histamine-2 receptor antagonist , lafutidine , in comparison with famotidine in patients with reflux esophagitis .


This was a randomized , double-blind , non-inferiority trial enrolling patients with erosive esophagitis .


The efficacy and safety of 20 mg lafutidine ( treatment group ) were compared with those of 40 mg famotidine ( control group ) and 20 mg omeprazole ( reference group ) .


The primary endpoint was the complete healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment .


The non-inferiority margin was assumed to be -15 % .


The healing rates of reflux esophagitis on endoscopy after 8 weeks of treatment were 70.14 % ( 101/144 ) in the lafutidine , 63.45 % ( 92/145 ) in the famotidine , and 85.71 % ( 126/147 ) in the omeprazole group .


The difference in healing rates between the lafutidine and famotidine groups was 6.69 % ( 95 % confidence interval = [ -4.14 to 17.52 ] ) .


In addition , lafutidine was superior to famotidine in clinical improvement ( 53.73 % vs. 39.55 % , P = 0.0200 ) .


Lafutidine was non-inferior to famotidine in healing of reflux esophagitis .


Lafutidine , however , was superior to famotidine in terms of symptom relief of reflux esophagitis .


Upper limb ( UL ) impairment is the most common disabling deficit following a stroke .


Previous studies have suggested that transcranial direct current stimulation ( tDCS ) enhances the effect of conventional therapies .


This pilot double-blind randomized control trial aimed to determine whether or not tDCS , combined with Wii virtual reality therapy ( VRT ) , would be superior to Wii therapy alone in improving upper limb function and quality of life in chronic stroke individuals .


Twenty participants were randomly assigned either to an experimental group that received VRT and tDCS , or a control group that received VRT and sham tDCS .


The therapy was delivered over 15 sessions with 13 minutes of active or sham anodal tDCS , and one hour of virtual reality therapy .


The outcomes included were determined using the Fugl-Meyer scale , the Wolf motor function test , the modified Ashworth scale ( MAS ) , grip strength , and the stroke specific quality of life scale ( SSQOL ) .


Minimal clinically important differences ( MCID ) were observed when assessing outcome data .


Both groups demonstrated gains in all evaluated areas , except for the SSQOL-UL domain .


Differences between groups were only observed in wrist spasticity levels in the experimental group , where more than 50 % of the participants achieved the MCID .


These findings support that tDCS , combined with VRT therapy , should be investigated and clarified further .


Insulin resistance and secretion depend on calcium homeostasis .


Cross-sectional studies have associated elevated serum calcium levels with markers of impaired glucose metabolism .


However , only one prospective cohort study has demonstrated an increased risk of diabetes in individuals with increased serum calcium concentrations .


The aim of the current study was to prospectively investigate the association between albumin-adjusted serum calcium concentrations and type 2 diabetes in subjects at high cardiovascular risk .


Prospective assessment of participants from two Spanish PREDIMED study centers where serum calcium levels were measured at baseline and yearly during follow-up .


Multivariate-adjusted Cox regression models were fitted to assess associations between baseline and changes during follow-up in serum calcium levels and relative risk of diabetes incidence .


After a median follow-up of 4.78 years , 77 new cases of type 2 diabetes occurred .


An increase in serum calcium levels during follow-up was related to an increased risk of diabetes .


In comparison with individuals in the lowest tertile ( -0.78 0.29 mg/dL ) , the hazard ratio ( HR ) and 95 % CI for diabetes incidence in individuals in the higher tertile of change ( 0.52 0.13 mg/dL ) during follow-up was 3.48 ( 95 % CI 1.48-8 .17 ; P for trend = 0.01 ) .


When albumin-adjusted serum calcium was analyzed as a continuous variable , per 1 mg/dL increase , the HR of diabetes incidence was 2.87 ( 95 % CI 1.18-6 .96 ; P value = 0.02 ) .


These associations remained significant after individuals taking calcium supplements or having calcium levels out of normal range had been excluded .


An increase in serum calcium concentrations is associated with an increased risk of type 2 diabetes in individuals at high cardiovascular risk .


To assess effectiveness and feasibility of public-private collaboration in delivering influenza immunization to children .


Four pediatric and four family medicine ( FM ) practices in Colorado with a common public health department ( PHD ) were randomized at the beginning of baseline year ( 10/2009 ) to Intervention ( joint community clinics and PHD nurses aiding in delivery at practices ) ; or control involving usual care without PHD .


Generalized estimating equations compared changes in rates over baseline between intervention and control practices at end of 2nd intervention year ( Y2 = 5/2011 ) .


Barriers to collaboration were examined using qualitative methods .


Overall , rates increased from baseline to Y2 by 9.2 % in intervention and 3.2 % in control ( p < .0001 ) , with significant increases in both pediatric and FM practices .


The largest increases were seen among school-aged and adolescent children ( p < .0001 for both ) , with differences for 6-month-old to 5-year-old children and for children with high-risk conditions not reaching significance .


Barriers to collaboration included uncertainty regarding the delivery of vaccine supplies , concerns about using up all purchased vaccine by practices , and concerns about documentation of vaccination if collaboration occurred .


In spite of barriers , public-private collaboration resulted in significantly higher influenza immunization rates , particularly for older , healthy children who visit providers less frequently .


The minimum alveolar concentration ( MAC ) of sevoflurane in neonates is 3.3 % , but this value has not been verified in Chinese neonates and the effect of different doses of fentanyl on MAC in neonates has not been investigated .


This study was designed to determine the ED and ED values of sevoflurane in Chinese neonates with and without fentanyl .


Ninety-three neonates were randomly assigned to receive sevoflurane alone ( control group , n = 30 ) , 1 g/kg sevoflurane ( group fent1 , n = 29 ) , or 2 g/kg fentanyl ( group fent2 , n = 32 ) .


Following inhalational induction and tracheal intubation , the end-tidal concentration of sevoflurane was adjusted to achieve the designated concentration , which was determined using the modified Dixon 's up-and-down method starting with 3.0 % in each group , with a 0.25 % step size .


Success was defined as no motor response within 60 s of skin incision .


The MAC ( standard deviation ) values of sevoflurane were 2.91 % ( 0.27 ) in the control group , 2.53 % ( 0.31 ) in the fent1 group , and 2.34 % ( 0.33 ) in the fent2 group according to Dixon 's up-and-down method .


Logistic probit regression analysis revealed that the ED and ED ( 95 % CI ) of sevoflurane in neonates were 2.82 % ( 2.66-2 .98 ) and 3.39 % ( 2.89-3 .89 ) , respectively , in the control group ; 2.44 % ( 2.19-2 .68 ) and 3.30 % ( 2.51-4 .09 ) , respectively , in the fent1 group ; and 2.21 % ( 1.97-2 .45 ) and 3.11 % ( 2.35-3 .88 ) , respectively , in the fent2 group .


The MAC value of sevoflurane in Chinese neonates was lower than previously reported and was reduced by the addition of fentanyl .


To compare intrauterine device ( IUD ) use at 6 months postpartum among women who underwent intracesarean delivery ( during cesarean delivery ) IUD placement compared with women who planned for interval IUD placement 6 or more weeks postpartum .


In this nonblinded randomized trial , women who were undergoing a cesarean delivery and desired an IUD were randomized to intracesarean delivery or interval IUD placement .


The primary outcome was IUD use at 6 months postpartum .


A sample size of 112 ( 56 in each group ) was planned to detect a 15 % difference in IUD use at 6 months postpartum between groups .


From March 2012 to June 2014 , 172 women were screened and 112 women were randomized into the trial .


Baseline characteristics were similar between groups .


Data regarding IUD use at 6 months postpartum were available for 98 women , 48 and 50 women in the intracesarean delivery and interval groups , respectively .


A larger proportion of the women in the intracesarean delivery group were using an IUD at 6 months postpartum ( 40/48 [ 83 % ] ) compared with those in the interval group ( 32/50 [ 64 % ] , relative risk 1.3 , 95 % confidence interval 1.02-1 .66 ) .


Among the 56 women randomized to interval IUD insertion , 22 ( 39 % ) of them never received an IUD ; 14 ( 25 % ) never returned for IUD placement , five ( 9 % ) women declined an IUD , and three ( 5 % ) had a failed IUD placement .


Intrauterine device placement at the time of cesarean delivery leads to a higher proportion of IUD use at 6 months postpartum when compared with interval IUD placement .


I.


Hemicraniectomy and Durotomy Upon Deterioration From Infarction-Related Swelling Trial ( HeADDFIRST ) was a randomized pilot study to obtain information necessary to design a Phase III trial to evaluate the benefit of surgical decompression for brain swelling from large supratentorial cerebral hemispheric infarction .


All patients with stroke were screened for eligibility ( age 18-75 years , National Institutes of Health Stroke Scale18 with Item 1a < 2 [ responsive to minor stimulation ] , and CT demonstrating unilateral , complete middle cerebral artery territory infarction by specific imaging criteria ) .


All enrolled patients were treated using a standardized medical treatment protocol .


Those with both4 mm of pineal shift and deterioration in level of arousal or 7.5 mm of anteroseptal shift within 96 hours of stroke onset were randomized to continued medical treatment only or medical treatment plus surgery .


Death at 21 days was the primary outcome measure .


Among 4909 screened patients , only 66 ( 1.3 % ) patients were eligible for HeADDFIRST .


Forty patients were enrolled , and 26 patients developed the requisite brain swelling for randomization .


All who failed to meet randomization criteria were alive at 21 days .


Mortality at 21 and 180 days was 40 % ( 4/10 ) in the medical treatment only and 21 % ( 3/14 ) and 36 % ( 5/14 ) in the medical treatment plus surgery arms , respectively .


HeADDFIRST randomization criteria effectively distinguished low from high risk of death from large supratentorial cerebral hemispheric infarction .


Lower mortality in the medical treatment only group than in other published trials suggests a possible benefit to standardizing medical management .


These results can inform the interpretation of recently completed European trials concerning patient selection and medical management .


This trial was not registered because enrollment began before July 1 , 2005 .


To compare clinical outcome and callus biomechanical properties of a novel angle stable interlocking nail ( AS-ILN ) and a 6 mm bolted standard ILN ( ILN6b ) in a canine tibial fracture model .


Experimental in vivo study .


Purpose-bred hounds ( n = 11 ) .


A 5 mm mid-diaphyseal tibial ostectomy was stabilized with an AS-ILN ( n = 6 ) or an ILN6b ( n = 5 ) .


Orthopedic examinations and radiographs were performed every other week until clinical union ( 18 weeks ) .


Paired tibiae were tested in torsion until failure .


Callus torsional strength and toughness were statistically compared and failure mode described .


Total and cortical callus volumes were computed and statistically compared from CT slices of the original ostectomy gap .


Statistical significance was set at P < .05 RESULTS : From 4 to 8 weeks , lameness was less pronounced in AS-ILN than ILN6b dogs ( P < .05 ) .


Clinical union was reached in all AS-ILN dogs by 10 weeks and in 3/5 ILN6b dogs at 18 weeks .


Callus mechanical properties were significantly greater in AS-ILN than ILN6b specimens by 77 % ( failure torque ) and 166 % ( toughness ) .


Failure occurred by acute spiral ( control and AS-ILN ) or progressive transverse fractures ( ILN6b ) .


Cortical callus volume was 111 % greater in AS-ILN than ILN6b specimens ( P < .05 ) .


Earlier functional recovery , callus strength and remodeling suggest that the AS-ILN provides a postoperative biomechanical environment more conducive to bone healing than a comparable standard ILN .


Guidelines recommendations regarding anticoagulant therapy after percutaneous coronary intervention ( PCI ) among patients with atrial fibrillation ( AF ) rely on retrospective , nonrandomized observational data .


Currently , patients are treated with triple-therapy ( dual antiplatelet therapy [ DAPT ] + oral anticoagulation therapy ) , but neither the duration of DAPT nor the level of anticoagulation has been studied in a randomized fashion .


Recent studies also suggest dual pathway therapy with clopidogrel plus oral anticoagulation therapy may be superior , and other studies suggest that novel oral anticoagulants such as rivaroxaban may further improve patient outcomes .


PIONEER AF-PCI ( ClinicalTrials.gov NCT01830543 ) is an exploratory , open-label , randomized , multicenter clinical study assessing the safety of 2 rivaroxaban treatment strategies and 1 vitamin K antagonist ( VKA ) treatment strategy in subjects who have paroxysmal , persistent , or permanent nonvalvular AF and have undergone PCI with stent placement .


Approximately 2,100 subjects will be randomized in a 1:1:1 ratio to receive either rivaroxaban 15 mg once daily plus clopidogrel 75 mg daily for 12 months ( a WOEST trial-like strategy ) , or rivaroxaban 2.5 mg twice daily ( with stratification to a prespecified duration of DAPT 1 , 6 , or 12 months , an ATLAS trial-like strategy ) , or dose-adjusted VKA once daily ( with stratification to a prespecified duration of DAPT 1 , 6 , or 12 months , traditional triple therapy ) .


All patients will be followed up for 12 months for the primary composite end point of Thrombolysis in Myocardial Infarction major bleeding , bleeding requiring medical attention , and minor bleeding ( collectively , clinically significant bleeding ) .


The PIONEER AF-PCI study is the first randomized comparison of VKA vs novel oral anticoagulant therapy in patients with NVAF receiving antiplatelet therapy after PCI to assess the relative risks of bleeding complications .


Roux-en-Y gastric bypass ( RYGB ) surgery causes profound weight loss and improves insulin sensitivity ( S ( I ) ) in obese patients .


Regular exercise can also improve S ( I ) in obese individuals ; however , it is unknown whether exercise and RYGB surgery-induced weight loss would additively improve S ( I ) and other cardiometabolic factors .


We conducted a single-blind , prospective , randomized trial with 128 men and women who recently underwent RYGB surgery ( within 1-3 months ) .


Participants were randomized to either a 6-month semi-supervised moderate exercise protocol ( EX , n = 66 ) or a health education control ( CON ; n = 62 ) intervention .


Main outcomes measured included S ( I ) and glucose effectiveness ( S ( G ) ) , which were determined from an intravenous glucose tolerance test and minimal modeling .


Secondary outcomes measured were cardiorespiratory fitness ( VO2 peak ) and body composition .


Data were analyzed using an intention-to-treat ( ITT ) and per-protocol ( PP ) approach to assess the efficacy of the exercise intervention ( > 120 min of exercise/week ) .


119 ( 93 % ) participants completed the interventions , 95 % for CON and 91 % for EX .


There was a significant decrease in body weight and fat mass for both groups ( P < 0.001 for time effect ) .


S ( I ) improved in both groups following the intervention ( ITT : CON vs. EX ; +1.64 vs. +2.24 min/U/ml , P = 0.18 for , P < 0.001 for time effect ) .


A PP analysis revealed that exercise produced an additive S ( I ) improvement ( PP : CON vs. EX ; +1.57 vs. +2.69 min/U/ml , P = 0.019 ) above that of surgery .


Exercise also improved S ( G ) ( ITT : CON vs. EX ; +0.0023 vs. +0.0063 min , P = 0.009 ) compared with the CON group .


Exercise improved cardiorespiratory fitness ( VO2 peak ) compared with the CON group .


Moderate exercise following RYGB surgery provides additional improvements in S ( I ) , S ( G ) , and cardiorespiratory fitness compared with a sedentary lifestyle during similar weight loss .


clinicaltrials.gov identifier : NCT00692367 .


This study was funded by the NIH/National Institute of Diabetes and Digestive and Kidney Diseases ( R01 DK078192 ) and an NIH/National Center for Research Resources/Clinical and Translational Science Award ( UL1 RR024153 ) .


Breast cancer is the most common female malignancy in the world .


Beta glucan can be a hematopoietic and an immune modulator agent in cancer patients .


The aim of this trial was to determine the effect of beta glucan on white blood cell counts and serum levels of IL-4 and IL-12 in women with breast cancer undergoing chemotherapy .


This randomized double-blind placebo-controlled clinical trial was conducted on 30 women with breast carcinoma aged 28-65 years .


The eligible participants were randomly assigned to intervention ( n = 15 ) or placebo ( n = 15 ) groups using a block randomization procedure with matching based on age , course of chemotherapy and menopause status .


Patients in the intervention group received two 10-mg capsules of soluble 1-3 , 1-6 , D-beta glucan daily and the control group receiving placebo during 21 days , the interval between two courses of chemotherapy .


White blood cells , neuthrophil , lymphocyte and monocyte counts as well as serum levels of IL-4 and IL-12 were measured at baseline and at the end of the study as primary outcomes of the study .


In both groups white blood cell counts decreased after 21 days of the intervention , however in the beta glucan group , WBC was less decreased non significantly than the placebo group .


At the end of the study , the change in the serum level of IL-4 in the beta glucan group in comparison with the placebo group was statistically significant ( p = 0.001 ) .


The serum level of IL-12 in the beta glucan group statistically increased ( p = 0.03 ) and comparison between two groups at the end of the study was significant after adjusting for baseline values and covariates ( p = 0.007 ) .


The findings suggest that beta glucan can be useful as a complementary or adjuvant therapy and immunomodulary agent in breast cancer patients in combination with cancer therapies , but further studies are needed for confirmation .


Ropivacaine-induced vasoconstriction may affect the early absorption speed of ropivacaine ; however , the effects of dose on pharmacokinetics following transversus abdominis plane ( TAP ) block have not been studied .


In this study , we have examined plasma ropivacaine concentrations following TAP block with various ropivacaine concentrations ( 0.25 , 0.5 , and 0.75 % ) .


With the approval of our University ethics committee and informed consent , 39 adult patients undergoing open retropubic prostatectomy were enrolled .


Patients were randomly assigned to three groups ( n = 13 each ) receiving TAP block with 20 ml ( 10 ml each side ) of different concentrations of ropivacaine .


To determine plasma concentrations , blood samples were drawn before and 15 , 30 , 45 , 60 , 90 , 120 , and 180 min after completion of bilateral TAP blocks .


Plasma ropivacaine concentrations were analyzed by gas chromatography with mass spectrometry .


We found that the peak plasma concentrations ( C ( max ) ) increased dose dependently ( 0.41 0.14 , 0.89 0.55 , and 1.56 0.50 g/ml ) , but the times to C ( max ) ( 23.0 15.8 , 23.1 14.5 , and 20.8 11.5 min ) were not different between 0.25 , 0.5 , and 0.75 % ropivacaine doses , respectively .


Terminal elimination half-life ( t ( 1/2 ) ) , total body clearance ( CL ) , and distribution volume ( V ( d ) ) were also not different among the three groups .


Ropivacaine concentration did not alter pharmacokinetic profile following TAP blocks .


There are a high number of adolescents who are at risk of developing an eating disorder .


There is , therefore , a strong need to implement prevention programs aimed at reducing the incidence of eating disorders at this critical age .


Among other factors , successful prevention programs have been shown to be interactive , carried out by professionals , focused on educational as well as psychosocial elements and have taken risk factors as well as resources into account .


The objective of this study protocol is to present the design of a new prevention program for eating disorders in schools .


The gender-adapted prevention program extends over six school hours .


It contains interactive and educational elements about eating disorders and their treatment .


Participants pass through different exercises and reflect on the influences of the media , self-esteem , body perception and individual resources .


A cluster-randomized controlled trial is chosen to evaluate the program .


Based on an estimated effect size of d = 0.3 a total of 1848 participants are enrolled in the study .


Eating disorder risk , internalization of Western beauty ideals , body dissatisfaction , self-concept as well as anxiety and symptoms of depression are measured before and immediately after the intervention as well as at a six-month follow-up .


In addition , the intervention group evaluates the different components of the program .


The study intends to test the practicability and efficacy of an interactive , gender-adapted ED prevention program in schools .