Deutsches Register Klinischer Studien ( German Clinical Trials Register ) : DRKS00000586.Universal Trial Number ( UTN U1111-1118-3464 ) .


The optimal second-line regimen for treating advanced gastric cancer ( AGC ) remains unclear .


While irinotecan ( CPT-11 ) plus cisplatin ( CDDP ) combination therapy and CPT-11 monotherapy have been explored in the second-line setting , the superiority of second-line platinum-based therapies for AGC patients initially treated with S-1 monotherapy has not yet been evaluated ; therefore , we aimed to examine the survival benefit of CPT-11 / CDDP combination over CPT-11 monotherapy .


AGC patients showing progression after S-1 monotherapy for advanced cancer or recurrence within 6 months after completion of S-1 adjuvant therapy were randomly allocated to CPT-11 / CDDP ( CPT-11 , 60 mg/m ( 2 ) ; CDDP , 30 mg/m ( 2 ) , q2w ) or CPT-11 ( 150 mg/m ( 2 ) , q2w ) .


Sixty-eight advanced and 95 recurrent cases were evaluated .


The median overall survivals were 13.9 ( 95 % confidence interval [ CI ] : 10.8-17 .6 ) and 12.7 ( 95 % CI : 10.3-17 .2 ) months for CPT-11 / CDDP and CPT-11 , respectively ( hazard ratio : 0.834 ; 95 % CI : 0.596-1 .167 , P = 0.288 ) .


No significant differences were observed in the secondary end-points , including progression-free survival ( 4.6 [ 95 % CI : 3.4-5 .9 ] versus 4.1 [ 95 % CI : 3.3-4 .9 ] months ) and response rate ( 16.9 % [ 95 % CI : 8.8-28 .3 ] versus 15.4 % [ 95 % CI : 7.6-26 .5 ] ) .


The incidences of grade 3-4 anaemia ( 16 % versus 4 % ) and elevated serum lactate dehydrogenase levels ( 5 % versus 0 % ) were higher for CPT-11 / CDDP than for CPT-11 .


Exploratory subgroup analysis revealed that CPT-11 / CDDP was significantly more effective for intestinal-type AGC , compared with CPT-11 ( overall survival : 15.8 versus 14.0 months ; P = 0.019 ) .


No survival benefit was observed upon adding CDDP to CPT-11 after S-1 monotherapy failure .


Postoperative delirium is the most common postoperative complication in the elderly .


The purpose of this study was to evaluate the safety and effectiveness of the preventive administration of low-dose haloperidol on the development of postoperative delirium after abdominal or orthopedic surgery in elderly patients .


A total of 119 patients aged 75 years or older who underwent elective surgery for digestive or orthopedic disease were included in this study .


Patients were divided into those who did ( intervention group , n = 59 ) and did not ( control group , n = 60 ) receive 2.5 mg of haloperidol at 18:00 daily for 3 days after surgery ; a randomized , open-label prospective study was performed on these groups .


The primary endpoint was the incidence of postoperative delirium during the first 7 days after the operation .


The incidence of postoperative delirium in all patients was 37.8 % .


No side effects involving haloperidol were noted ; however , the incidences of postoperative delirium were 42.4 and 33.3 % in the intervention and control groups , respectively , which were not significantly different ( p = 0.309 ) .


No significant effect of the treatment was observed on the severity or persistence of postoperative delirium .


The preventive administration of low-dose haloperidol did not induce any adverse events , but also did not significantly decrease the incidence or severity of postoperative delirium or shorten its persistence .


There are insufficient data to guide perioperative implantable cardioverter-defibrillator ( ICD ) management for patients undergoing surgical procedures using electrocautery .


We conducted a multicenter randomized controlled trial of patients with ICDs undergoing surgery with monopolar electrocautery .


Subjects were randomized to an `` Off '' group ( ICD therapy programmed off , then postoperatively programmed on ) or a `` Magnet '' group ( ICD therapy suspended with a magnet and no immediate postoperative ICD interrogation ) .


Also , a registry was maintained of ICD patients with procedures within 6 inches of the ICD ( all programmed off ) .


The primary endpoint was ICD off time with secondary endpoints being caregiver handoffs and incidence of electromagnetic interference ( EMI ) .


All patients ( n = 80 ) had pectoral ICDs .


Subject demographics were well matched in each group , and duration of electrocautery was similar ( 80 minutes vs 64 minutes , P = 0.58 ) .


The mean `` excess '' ICD off time ( ICD off time - electrocautery time ) was significantly higher in the Off group than the Magnet group ( 115 minutes vs 28 minutes , P < 0.001 ) .


Mean number of caregiver handoffs were higher in the Off group ( 6.6 vs 5.5 , P < 0.001 ) .


There was no EMI in any lower abdominal or lower extremity procedures .


Neither group had arrhythmic events or device reset .


A magnet protocol simplifies perioperative ICD management for procedures using electrocautery more than 6 inches from the ICD .


This protocol results in significantly shorter time with ICD therapy off , fewer provider handoffs , no risk of inadvertently discharging patients home with ICD therapies off , and no device reset .


This phase 2 study examined the efficacy and tolerability of edivoxetine , a highly selective norepinephrine reuptake inhibitor , as an adjunctive treatment for patients with major depressive disorder ( MDD ) who have a partial response to selective serotonin reuptake inhibitor ( SSRI ) treatment .


Study design consisted of double-blind , 10-week therapy of adjunctive edivoxetine ( 6-18 mg once daily ) or adjunctive placebo with SSRI .


Inclusion/entry criteria included partial response to current SSRI by investigator opinion and a GRID 17-item Hamilton Rating Scale for Depression ( HAMD17 ) total score 16 .


The primary efficacy measure was the Montgomery-Asberg Depression Rating Scale ( MADRS ) .


Safety measures included treatment-emergent adverse events ( TEAE ) and vital signs .


For the primary evaluable population ( n = 63 for adjunctive edivoxetine and n = 68 for adjunctive placebo ) , the treatment groups did not differ significantly on the primary outcome of change from baseline to week 8 in the MADRS total score ; the effect size of edivoxetine treatment was 0.26 .


Significant treatment differences , favoring adjunctive edivoxetine ( p. 05 ) , were shown for improvements in role functioning and the functional impact of fatigue .


For the adjunctive edivoxetine randomized group ( N = 111 ) , the most frequent TEAEs were hyperhidrosis ( 7.2 % ) , nausea ( 7.2 % ) , erectile dysfunction ( 6.3 % ) and testicular pain ( 6.3 % ) .


Hemodynamic changes were observed in blood pressure and pulse rate between treatment groups .


Study was underpowered for an alpha 2-sided 0.05 significance level for the primary outcome .


For patients with MDD who had a partial response to SSRIs , adjunctive edivoxetine treatment was not statistically superior to adjunctive placebo on the primary outcome measure .


However , pending further study , improved functioning and remission rate suggest a potential role for edivoxetine for patients with depression .


We assessed the effectiveness of the Luoghi di Prevenzione-Prevention Grounds school-based smoking prevention programme .


We undertook a cluster randomized controlled trial of 989 students aged 14-15 years in 13 secondary schools located in Reggio Emilia , Italy .


The intervention consisted of the `` Smoking Prevention Tour '' ( SPT ) out-of-school workshop , one in-depth lesson on one Smoking Prevention Tour topic , a life-skills peer-led intervention , and enforcement surveillance of school antismoking policy .


Self-reported past 30-day smoking of 20 or 1-19 days of cigarette smoking ( daily or frequent smoking , respectively ) was recorded in 2 surveys administered immediately before and 18 months after the beginning of the programme .


Analysis was by intention to treat .


The effect of the intervention was evaluated using random effects logistic regression and propensity score-matching analyses .


Past 30-day smoking and daily cigarette use at eighteen months follow-up were 31 % and 46 % lower , respectively , for intervention students compared to control students .


Taking into account non-smokers at baseline only , daily smoking at eighteen months follow-up was 59 % lower in intervention students than in controls .


Past 30-day smoking in school areas was 62 % lower in intervention students compared to controls .


The Luoghi di Prevenzione-Prevention Grounds programme was effective in reducing daily smokers and in reducing smoking in school areas .


To assess the efficacy of dapagliflozin , a sodium-glucose cotransporter 2 inhibitor , for the treatment of individuals with type 2 diabetes mellitus ( T2DM ) and preexisting cardiovascular disease ( CVD ) .


Randomized , double-blind , age-stratified ( < 65 and 65 ) , 24-week clinical trial with a 28-week extension .


One hundred seventy-three centers in 10 countries .


Individuals ( N = 964 ) with T2DM , glycosylated hemoglobin ( HbA1c ) of 7.0 % to 10.0 % , and documented CVD .


Dapagliflozin 10 mg/d or placebo was added to usual care .


Participants receiving insulin had their total daily insulin dose reduced by 25 % at randomization .


Two equal primary end points : change from baseline in HbA1c and proportion of participants achieving a three-item end point ( reduction of 0.5 % in HbA1c , 3 % in body weight , and 3 mmHg in systolic blood pressure ) at 24 weeks .


Forty-seven percent were aged 65 and older , 7.7 % were aged 75 and older , mean duration of T2DM was 13 years , mean baseline HbA1c was 8.1 % , and approximately 60 % were taking insulin .


The placebo-corrected change in HbA1c with dapagliflozin was -0.4 % at 24 weeks .


Significantly more participants achieved the three-item end point with dapagliflozin ( 10.0 % ) than with placebo ( 1.9 % ) .


The placebo-corrected percentage change in body weight for dapagliflozin was -1.9 % ( -1.8 kg ) .


Similar results were observed in both age strata , and changes were maintained over 52 weeks .


More than one-quarter ( 28.2 % ) of participants receiving dapagliflozin and 25.3 % of those receiving placebo experienced hypoglycemia .


More participants receiving dapagliflozin had vulvovaginitis , balanitis , or urinary tract infection .


When added to a usual background regimen in an older population with advanced T2DM and preexisting comorbid CVD , dapagliflozin improved glycemic control without an increase in hypoglycemic risk , promoted weight loss , and was well tolerated .


A recent international , multicenter , double-blinded , randomized trial shows delayed-enhanced magnetic resonance imaging ( DE-MRI ) using contrast doses of 0.2 mmol/kg is effective in the detection and assessment of myocardial infarction ( MI ) , and 0.1 mmol/kg is not enough ; intermediate doses between 0.1 and 0.2 mmol/kg have not been tested .


The aim of this study was to prospectively test the performance of DE-MRI using 0.15 mmol/kg of contrast agent for the detection of MI .


A total of 31 consecutive patients with chronic MI underwent DE-MRI at 3.0 T using both 0.15 mmol/kg and 0.2 mmol/kg of contrast agent in random order and on separate days .


Infarction segment and infarction size were compared on DE-MRI images using a 17-segment model .


Bland-Altman analysis was used to analyze correlation and agreement between global infarct sizes .


DE-MRI showed enhanced myocardium in all the 31 patients with chronic MI .


There was no significant difference between the 0.15 mmol/kg and 0.2 mmol/kg images in all 31 patients based on the infarction segment ( 7.872.72 vs. 7.812.64 , respectively ; p = 0.33 ) .


There was no significant difference between the infarction size obtained from 0.15 mmol/kg acquisition and that from 0.2 mmol/kg acquisition ( 16.37.8 % vs. 16.47.9 % , respectively ; p = 0.87 ) .


A strong correlation between the infarction size obtained from 0.15 mmol/kg acquisition and that from 0.2 mmol/kg acquisition was indicated through Bland-Altman analysis .


DE-MRI at 3.0 T using 0.15 mmol/kg of contrast agent is effective for the assessment of MI .


A sudden gain is defined as a large and stable individual improvement occurring between two consecutive treatment sessions .


Sudden gains have been shown to predict better long-term improvement in several treatment studies , including cognitive behavioural therapy for depression and anxiety disorders , but have not been studied in the treatment of health anxiety or any form of internet-based cognitive behavioural therapy .


The aim of this study was to investigate the role of sudden gains in internet-based cognitive behavioural therapy for severe health anxiety .


We examined the occurrence and significance of sudden gains in measures of health anxiety in 81 participants receiving internet-based cognitive behavioural therapy .


We compared patients with sudden gains , patients without sudden gains , and patients with gradual gains .


Thirteen participants ( 16 % ) experienced one sudden gain in health anxiety with individual sudden gains distributed across the treatment .


As expected , patients with a sudden gain showed larger improvements than patients without a sudden gain at post-treatment ( d = 1.04 ) and at one-year follow-up ( d = 0.91 ) on measures of health anxiety .


Consistent with previous studies , sudden gains in internet-based cognitive behavioural therapy are associated with significantly larger and stable treatment effects up to one-year follow-up .


Same-sex attracted young adults have been found to experience higher rates of mental health problems and greater difficulties in accessing specialist mental health care services compared to their heterosexual peers .


Internet-based mental health interventions have the potential to be more engaging and accessible to young adults compared to those delivered face-to-face .


However , they are rarely inclusive of lesbian women and gay men .


Thus , the current study aims to evaluate the effectiveness of an online mental health and wellbeing program , Out & Online ( http://www.outandonline.org.au ) , in comparison to a wait-list control group , for reducing anxiety and depressive symptoms in same-sex attracted young adults aged between 18 and 25 years .


We are recruiting , through media and community organisations , 200 same-sex attracted young adults with anxiety and/or depressive symptoms and mild to moderate psychological distress ( Kessler-10 score between 16 to 21 ) .


Participants will be randomly allocated to the intervention ( the online program ) or the wait-list control group based on a permuted blocked randomisation method to allow for stratification by gender .


Participants in the intervention group will receive a tailored program for up to three types of mental health difficulties simultaneously .


The primary outcome of anxiety and/or depressive symptoms , and secondary outcomes related to psychological distress , wellbeing and health behaviour will be measured at pre-intervention ( 0 week ) , post-intervention ( 8 weeks ) and at a 3-month follow-up ( 20 weeks ) .


This online mental health and wellbeing program will be one of the first online interventions to be designed specifically to be relevant for same-sex attracted individuals .


If the program is found to be effective it will improve access to specialist same-sex attracted-relevant mental health services for young adults and will facilitate wellbeing outcomes for these individuals .


This program will also be a significant development in the delivery of tailored interventions that target multiple types of mental health conditions simultaneously .


Australian New Zealand Clinical Trials Registry : ACTRN12611000700932 .


Date registered : 7 July 2011 .


Endometriosis affects fertility negatively .


The study aims to evaluate whether laparoscopic surgery combined with oral contraceptive or herbs were more effective than laparoscopic alone in improving fecundity and pelvic pain in women with minimal/mild endometriosis .


A randomized controlled trial ( RCT ) was conducted in 156 infertile women with minimal/mild endometriosis .


After laparoscopic surgery , patients were randomized to three groups : in Group A ( n = 52 ) oral contraceptive ( OC ) was administered one pill a day , continuous for 63days without intervals , in Group B ( n = 52 ) OC was administered as above and then Dan ' e mixture was added 30g/day for the latter 30days , and in control Group C ( n = 52 ) patients tried to get pregnant after surgery without complementary treatment .


The follow-up periods were 12months in Group C and 14months in complementary medical treatment Group A and B.


The pregnant women were further followed up , and labor and pregnancy outcomes were assessed .


Primary outcome was pregnancy rate ( PR ) and live birth rate ( LBR ) .


Secondary outcomes included changes of pelvic pain visual analog scale scores and side effects .


Analyses were done as intention-to-treat .


The PR was 46.80 % ( 73/156 ) , and the LBR was 69.86 % ( 51/73 ) .


Of the 73 pregnancies , 60 occurred within 12months of follow-up and 7 of the remaining 13 patients underwent assisted reproductive technology for > 1year .


No significant difference was observed in PR and LBR among the three groups .


Patients given medical treatment ( OCs or OCs plus herbal medicine ) had significantly decreased pain scores compared with the laparoscopy alone group .


Combination of laparoscopy with OCs or OCs and herbal medicine does not have more advantages than laparoscopy alone in improving fertility of women with minimal/mild endometriosis .


ChiCTR-TRC-11001820 .


To explore the effect of continuous nursing intervention guided by chronotherapeutics so as to provide the easy , noninvasive , effective and acceptable intervention for older hypertensive patients in the community .


Many researchers studied the effect of administration at different times on blood pressure control and circadian rhythm .


However , the individual administrative time was set ambiguously in previous studies .


A semi-experimental study .


In the study , 90 eligible patients were recruited and separated into three groups randomly , which were the control group , intervention group A ( behaviour and chronotherapy intervention ) and intervention group B ( behaviour intervention ) .


At 6 and 12months after the study , the intervention groups were measured 24-hour ambulatory blood pressure monitoring .


There were significant differences in ambulatory blood pressure monitoring parameters of the two intervention groups at different measurement times , and there were interaction between measurement time and different groups .


The number of patients with dipper increased and reverse dipper decreased in group A as the intervention applied .


There were statistical differences between two groups .


The number of patients with morning surge in group A decreased more , and there were statistical differences between two groups at six months after the intervention .


The behaviour and chronotherapy intervention based on the patients ' ambulatory blood pressure monitoring can control casual blood pressure much better and last longer , which can also improve patients ' indexes of ambulatory blood pressure monitoring better than behaviour intervention only .


The behaviour and chronotherapy intervention can increase patients ' nocturnal blood pressure drop , increase the number of patients with dipper and decrease reverse dipper , and improve blood pressure surge in the morning .


Nurses can use continuous nursing intervention guided by chronotherapeutics to help improve hypertension of older patients better in the community .


To test the impact of the method of administration ( MOA ) on score level , reliability , and validity of scales developed in the Patient Reported Outcomes Measurement Information System ( PROMIS ) .


Two nonoverlapping parallel forms each containing eight items from each of three PROMIS item banks ( Physical Function , Fatigue , and Depression ) were completed by 923 adults with chronic obstructive pulmonary disease , depression , or rheumatoid arthritis .


In a randomized crossover design , subjects answered one form by interactive voice response ( IVR ) technology , paper questionnaire ( PQ ) , personal digital assistant ( PDA ) , or personal computer ( PC ) and a second form by PC , in the same administration .


Method equivalence was evaluated through analyses of difference scores , intraclass correlations ( ICCs ) , and convergent/discriminant validity .


In difference score analyses , no significant mode differences were found and all confidence intervals were within the prespecified minimal important difference of 0.2 standard deviation .


Parallel-forms reliabilities were very high ( ICC = 0.85-0 .93 ) .


Only one across-mode ICC was significantly lower than the same-mode ICC .


Tests of validity showed no differential effect by MOA .


Participants preferred screen interface over PQ and IVR .


We found no statistically or clinically significant differences in score levels or psychometric properties of IVR , PQ , or PDA administration compared with PC .


Prospective randomized study .


This study aimed to prospectively compare the surgical results of the open - and French-door laminoplasty .


Cervical laminoplasty is a common surgical procedure for the treatment of cervical compressive myelopathy .


These procedures are primarily classified as either open - or French-door laminoplasties .


Only few prospective studies comparing the surgical results of the 2 procedures are available .


A total of 92 patients with cervical compressive myelopathy who underwent cervical laminoplasty were prospectively enrolled and randomized into the following 2 groups according to the type of laminoplasty : open-door and French-door groups .


A single attending spine surgeon performed all surgical procedures .


The following factors were evaluated : surgical duration , blood loss , perioperative complications , neurological assessment using the Japanese Orthopedic Association score , and recovery rate .


Radiological evaluations included assessment of the cervical lordotic angle and cervical range of motion .


In addition , the ratio of postoperative spinal lamina opening was evaluated by magnetic resonance imaging .


There were no differences in perioperative complications and neurological outcomes between the 2 groups .


The mean reduction in cervical lordotic angle after surgery was significantly greater in the open-door group than the French-door group ( 3.0 vs. 5.6 ) .


Postoperative cervical range of motion significantly decreased in the open-door group than in the French-door group ( 19.3 vs. 26.0 ) .


Postoperative cervical lordotic angle in the extension position significantly diminished in the open-door group than in the French-door group ( 7.9 vs. 14.1 ) .


The ratio of opening of the spinal lamina after surgery was significantly larger in the open-door group than in the French-door group .


The 2 laminoplasty methods showed almost the same neurological recovery as well as perioperative complications .


In cases of open-door laminoplasty , postoperative cervical alignment became more kyphotic and cervical range of motion was more restricted than that in French-door laminoplasty cases after surgery .


French-door laminoplasty is preferable to open-door laminoplasty for postoperative cervical alignments .


1 .


Burnout is a very prevalent type of stress among health professionals .


It affects their well-being , performance , and attitude toward patients .


This study assessed the effectiveness of a training program for primary health care professionals designed to reduce burnout and mood disturbance , increase empathy , and develop mindfulness .


Pragmatic randomized controlled trial with pre - and postintervention measurements of 68 primary health care professionals ( 43 in the intervention and 25 in the control group ) in Spain .


The intervention consisted of presentations of clinically relevant topics , mindfulness-based coping strategies , mindfulness practice , yoga , and group discussions ( 8 sessions of 2.5 hours per week plus a 1-day session of 8 hours ) .


Outcome measures included the Maslach Burnout Inventory , Profile of Mood States , Jefferson Scale of Physician Empathy , Baer 's Five Facets Mindfulness Questionnaire , and a questionnaire on changes in personal habits and mindfulness practice .


Measurements were performed at baseline and after 8 weeks .


The intervention group improved in the 4 scales measured .


The magnitude of the change was large in total mood disturbance ( difference between groups -7.1 ; standardized effect-size [ SES ] 1.15 ) and mindfulness ( difference between groups 11 ; SES 0.9 ) and moderate in the burnout ( difference between groups -7 ; SES 0.74 ) and empathy scales ( difference between groups 5.2 ; SES 0.71 ) .


No significant differences were found in the control group .


Our study supports the use of mindfulness-based programs as part of continuing professional education to reduce and prevent burnout , promote positive attitudes among health professionals , strengthen patient-provider relationships , and enhance well-being .


Anogenital warts are a common disorder associated with significant physical and mental distress and a substantial cause of health care costs .


To assess the efficacy of the topical application of nitric oxide delivered using acidified nitrite .


A multicenter , randomized , controlled , dose-ranging clinical trial was conducted in European genitourinary medicine clinics between December 20 , 2001 , and January 14 , 2003 .


Analysis was by intent to treat for all individuals initiating therapy .


Participants included male and female volunteers older than 18 years with between 2 and 50 external anogenital warts .


A total of 299 individuals from 40 centers were randomized to a control arm and a treatment arm that received 3 doses of acidified nitrite applied topically for 12 weeks with an additional 12 weeks of follow-up , with the final follow-up visit on January 14 , 2003 .


Placebo nitrite cream and placebo citric acid cream were applied twice daily .


Active treatment was divided as low dose ( sodium nitrite , 3 % , with citric acid , 4.5 % , creams applied twice daily ) , middle dose ( sodium nitrite , 6 % , with citric acid , 9 % , creams applied once daily at night , with placebo applied in the morning ) , and high dose ( sodium nitrite , 6 % , with citric acid , 9 % , creams applied twice daily ) .


The primary outcome was proportion of patients with complete clinical clearance of target warts ; secondary outcomes were reduction in target wart area and safety .


Complete clinical clearance at 12 weeks occurred in 10 of 74 patients ( 14 % ; 95 % CI , 6 % -21 % ) with placebo ; 11 of 72 ( 15 % ; 95 % CI , 7 % -24 % ) with low-dose treatment ; 17 of 74 ( 23 % ; 95 % CI , 13 % -33 % ) with middle-dose treatment ; and 22 of 70 ( 31 % ; 95 % CI , 21 % -42 % ) with high-dose treatment ( P = .01 ) .


Reduction in target wart area , time to clearance , and patient and investigator assessments supported the superiority of the high-dose therapy vs placebo .


There were no systemic or serious adverse events associated with treatment .


However , there was a dose-related increase in itching , pain , edema , and staining of the anogenital skin associated with the active treatment .


Overall , 21 patients withdrew from active treatment because of adverse events compared with none using placebo .


Use of sodium nitrite , 6 % , with citric acid , 9 % , twice daily is more effective than placebo in the treatment of anogenital warts .


Treatment was associated with local irritant adverse effects .


clinicaltrials.gov Identifier : NCT02015260 .


Noncardiac chest pain ( NCCP ) is seen more frequently in young population and in these patients loss of function is evolving in social and professional areas .


The aim of the study is to evaluate the levels of anxiety and somatic perception in patients with chest pain presenting to cardiology clinic .


Fifty-one patients with noncardiac chest pain and 51 healthy controls were included in the study .


All participants performed self-report based health anxiety inventory ( HAI ) , somatosensory amplification scale ( SAS ) , and Toronto alexithymia scale ( TAS ) .


The patient group had significantly higher scores on the SAS , HAI-1 , and HAI-T scales compared to controls ( P < 0.001 , P = 0.006 , and P = 0.038 , resp . )


SAS , HAI-1 , and HAI-T scores were significantly higher in female patients than male ( P = 0.002 , 0.036 , and 0.039 , resp . )


There were significant differences in all TAS subscale scores between two groups .


Patients , who had total TAS score more than 50 , also presented higher levels of health anxiety ( P = 0.045 ) .


Anxiety , somatic symptoms , and the exaggerated sense of bodily sensations are common in patients with NCCP .


These patients unnecessarily occupy the cardiology outpatient clinics .


These negative results can be eliminated when consultation-liaison psychiatry evaluates these patients in collaboration with cardiology departments .


To compare the differences in the clinical efficacy on Alzheimer 's disease between acupuncture and medicine .


One hundred and forty-one patients were randomized into an acupuncture group ( 72 cases ) and a medicine group ( 69 cases ) .


In the acupuncture group , the needling technique for benefiting qi , promoting blood circulation , regulating mind and improving intelligence was used at Shenting ( GV 24 ) , Baihui ( GV 20 ) , Fengchi ( GB 20 ) , Wangu ( GB 12 ) , Danzhong ( CV 17 ) , Zhangwan ( CV 12 ) , Qihai ( CV 6 ) , Xuehai ( SP 10 ) and Zusanli ( ST 36 ) .


The supplementary acupoints were selected according to the symptoms and physical signs .


Acupuncture was given once a day and 6 treatments were required for a week .


In the medicine group , the choline sterase inhibitor , donepezil ( aricept ) was prescribed for oral administration , 1 tablet ( 5 mg ) each time , once every night .


Four weeks later , the dose was increased to 2 tablets ( 10 mg ) each time .


In the two groups , the treatment of 4 weeks made one session and 4 sessions were required .


The changes of scores before and after treatment in the minimum mental state examination ( MMSE ) , the activity of daily living scale ( ADL ) , Alzheimer 's disease assessment scale-cognition ( ADAS-cog ) and the digit span ( DS ) were observed .


After treatment , scores of MMSE and DS were increased as compared with those before treatment ( both P < 0.05 ) and scores of ADL and ADAS-cog were reduced as compared with those before treatment .


The score differences in MMSE , ADL , ADAS-cog and DS before and after treatment were significant in the two groups ( all P < 0.01 ) .


The needling technique for benefiting qi , promoting blood circulation , regulating mind and improving intelligence significantly improves the overall function , cognition and activity of daily life in the patients of Alzheimer 's disease and the efficacy is better than donepezil .


There is little evidence available on the use of robot-assisted therapy in subacute stroke patients .


A randomized controlled trial was carried out to evaluate the short-time efficacy of intensive robot-assisted therapy compared to usual physical therapy performed in the early phase after stroke onset .


Fifty-three subacute stroke patients at their first-ever stroke were enrolled 307days after the acute event and randomized into two groups , both exposed to standard therapy .


Additional 30 sessions of robot-assisted therapy were provided to the Experimental Group .


Additional 30 sessions of usual therapy were provided to the Control Group.The following impairment evaluations were performed at the beginning ( T0 ) , after 15 sessions ( T1 ) , and at the end of the treatment ( T2 ) : Fugl-Meyer Assessment Scale ( FM ) , Modified Ashworth Scale-Shoulder ( MAS-S ) , Modified Ashworth Scale-Elbow ( MAS-E ) , Total Passive Range of Motion-Shoulder/Elbow ( pROM ) , and Motricity Index ( MI ) .


Evidence of significant improvements in MAS-S ( p = 0.004 ) , MAS-E ( p = 0.018 ) and pROM ( p < 0.0001 ) was found in the Experimental Group .


Significant improvement was demonstrated in both Experimental and Control Group in FM ( EG : p < 0.0001 , CG : p < 0.0001 ) and MI ( EG : p < 0.0001 , CG : p < 0.0001 ) , with an higher improvement in the Experimental Group .


Robot-assisted upper limb rehabilitation treatment can contribute to increasing motor recovery in subacute stroke patients .


Focusing on the early phase of stroke recovery has a high potential impact in clinical practice .


In advanced gastric cancer ( AGC ) , no globally accepted prognostic scoring system has been developed .


Therefore , we explored baseline prognostic factors in Japanese AGC patients using the data from a randomized controlled trial , Japan Clinical Oncology Group ( JCOG ) 9912 , which investigated the efficacy of systemic chemotherapy as a first-line treatment .


Prognostic factors and prognostic indices for overall survival were screened and evaluated in patients enrolled in JCOG9912 using the Cox proportional hazard model .


The Royal Marsden Hospital prognostic model was also applied to the JCOG9912 trial .


A total of 650 ( 92.3 % ) of the 704 patients randomized in the JCOG9912 trial , for whom complete data were available for multivariate analyses , was included in the present study ( 5-fluorouracil arm , n = 215 ; irinotecan plus cisplatin arm , n = 216 ; S-1 arm , n = 219 ) .


The median survival time ( MST ) for all patients was 11.8 months .


To construct a prognostic index , we selected four risk factors by multivariate analysis : performance status 1 , number of metastatic sites 2 , no prior gastrectomy , and elevated alkaline phosphatase .


MSTs were 17.0 months for patients categorized into the low-risk group , who had zero or one risk factor ( n = 225 ) ; 10.4 months for patients in the moderate-risk group , who had two or three risk factors ( n = 368 ) ; and 5.0 months for patients in the high-risk group , who had all four risk factors ( n = 57 ) .


In the present study , we propose a new prognostic index for patients with AGC .


This can be used for more appropriate patient stratification in future clinical trials .


Treatment of food allergy essentially consists of food avoidance , but immunotherapy with food is emerging as a new therapeutic option .


To evaluate clinical improvement and immunological changes in patients with peach allergy following sublingual immunotherapy ( SLIT ) with a Prup3 quantified peach extract .


A randomized , double-blind , placebo-controlled clinical trial with peach SLIT was conducted .


We assessed clinical efficacy after 6 months of treatment by means of double-blind , placebo-controlled oral challenges with peach and also evaluated immunological changes ( basophil activation test [ BAT ] and determination of sulphidoleukotriene production ) following stimulation with peach peel and pulp , rPrup3 , rMald 1 , and rMal d 4 stimulation .


We also measured specific IgE and IgG4 to Pru p3 .


After 6 months of SLIT ( T6 ) , the active group showed a 3-fold improvement in tolerance to Prup3 and a significant increase in IgE to rPrup3 and in sLT production following stimulation with peach peel and rPrup3 .


There was also a significant increase in BAT results after stimulation with rPrup3 at 1 month of SLIT ( T1 ) .


Statistically significant between-group differences were only observed for BAT with peach peel and pulp at T1 and T6 and for BAT with rPru p3 at T6 .


No changes were observed in BAT with rMal d 1 or rMal d 4 or in IgG4 levels to nPrup3 .


SLIT with a Pru p 3 quantified peach extract is clinically effective and leads to an increase in basophil activation and sulphidoleukotriene production following stimulation with rPru p3 and peach peel in the first months of treatment .


Pharmacogenetics ( PGx ) promises to optimize patient response to therapy .


However , the public 's acceptance of PGx is not well known , notably when this applies to children .


Our objective was to explore perceptions of PGx testing among individuals , who differ from each other by either parental status or educational exposure to PGx , and to explore parents ' views between PGx testing for oneself and PGx testing for their children .


An exploratory survey was conducted among parents and other adults .


Surveys P and C were completed by parents , survey NP by middle-aged nonparents , and survey MS by medical students .


Proper explanation before PGx testing appeared to be the most important issue to the respondents ( eg , P = 1.55 10 ( -38 ) for survey NP ) .


Respondents who were more knowledgeable about PGx were also more comfortable with PGx testing ( eg , P = 2.53 10 ( -7 ) in case of mild disease ) .


When PGx testing was for one 's child , parents valued their own understanding more than their child 's assent ( P = 1.57 10 ( -17 ) ) .


The acceptability of PGx testing , either for oneself or for one 's child , seemed to depend on baseline PGx knowledge , but not on parenthood .


Dilatation and curettage ( D&C ) is a common day-care procedure in obstetrics and gynecology , with patients discharged after a brief hospital stay on the same day of the surgery .


Although it has a short duration , severe pain occurs during the procedure .


Therefore , this surgical procedure requires an anesthetic to provide adequate analgesia , rapid onset , and rapid recovery .


The main objective of the present study was to compare the analgesic effectiveness and safety of tramadol with those of fentanyl during D&C .


The study comprised 100 women with American Society of Anesthesiologists classification I-II who were scheduled for a D&C procedure .


Baseline anesthesia was maintained with 1mg/kg propofol , and the patients were then randomly allocated to receive tramadol 1mg/kg ( Group T , n = 50 ) or fentanyl 1g/kg ( Group F , n = 50 ) .


Hemodynamic variables , sedation , pain , the Aldrete recovery score , and side-effects were recorded .


SpO levels in Group F in the 5th min and at the end of the procedure were significantly lower than those in Group T ( P = 0.024 and 0.021 , respectively ) .


Tramadol provides similar analgesic efficacy to fentanyl .


Furthermore , tramadol may provide better respiratory stability in patients undergoing a D&C procedure .


Based on current recommendations , 30 + pack-years of smoking are required for eligibility for low-dose CT ( LDCT ) lung cancer screening ; former smokers must have quit within 15 years .


We investigated whether current smokers with 20 to 29 pack-years have similar lung cancer risks as eligible former smokers and also whether they have a different demographic profile .


The Prostate , Lung , Colorectal , and Ovarian Cancer Screening Trial ( PLCO ) was a randomly assigned screening trial of subjects age 55 to 74 years with chest radiographs ( CXR ) used for lung cancer .


Subjects completed a baseline questionnaire containing smoking history questions .


Cox proportional hazards models , adjusted for age and sex , were utilized to estimate hazard ratios ( HRs ) for various smoking history groups .


Next , we utilized the National Health Interview Survey ( NHIS ) , which inquired about smoking history and race/ethnicity , to analyze the demographic profiles of various high-risk smoking history categories .


All statistical tests were two-sided .


The PLCO cohort included 18 114 former and 12 243 current LDCT-eligible smokers , plus 2283 20 - to 29-pack-year current smokers .


The hazard ratio for 20 - to 29-pack-year current smokers compared with eligible ( 30 + pack-year ) former smokers was 1.07 ( 95 % confidence interval [ CI ] = 0.75 to 1.5 ) .


Based on the NHIS , 10 million persons in the United States are currently LDCT eligible ; an additional 1.6 million ( 16 % , 95 % CI = 13.6 % to 19.0 % ) are 20 - to 29-pack-year current smokers .


The percentage increase in eligibles if 20 - to 29-pack-year current smokers were included was substantially greater for women than men ( 22.2 % , 95 % CI = 17.9 % to 26.7 % ; vs 12.2 % , 95 % CI = 9.3 % to 15.3 % , P < .001 ) and for minorities than non-Hispanic whites ( 30.0 % , 95 % CI = 24.2 % to 36.0 % ; vs 14.1 % , 95 % CI = 11.1 % to 17.0 % , P < .001 ) .


The potential benefits and harms of recommending LDCT screening for 20 to 29-pack-year current smokers should be assessed .


Progression-free survival ( PFS ) in metastatic castration-resistant prostate cancer ( mCRPC ) trials has been inconsistently defined and poorly associated with overall survival ( OS ) .


A reproducible quantitative definition of radiographic PFS ( rPFS ) was tested for association with a coprimary end point of OS in a randomized trial of abiraterone in patients with mCRPC .


rPFS was defined as two new lesions on an 8-week bone scan plus two additional lesions on a confirmatory scan , two new confirmed lesions on any scan 12 weeks after random assignment , and/or progression in nodes or viscera on cross-sectional imaging , or death .


rPFS was assessed by independent review at 15 % of deaths and by investigator review at 15 % and 40 % of deaths .


rPFS and OS association was evaluated by Spearman 's correlation .


A total of 1,088 patients were randomly assigned to abiraterone plus prednisone or prednisone alone .


At first interim analysis , the hazard ratio ( HR ) by independent review was 0.43 ( 95 % CI , 0.35 to 0.52 ; P < .001 ; abiraterone plus prednisone : median rPFS , not estimable ; prednisone : median rPFS , 8.3 months ) .


Similar HRs were obtained by investigator review at the first two interim analyses ( HR , 0.49 ; 95 % CI , 0.41 to 0.60 ; P < .001 and HR , 0.53 ; 95 % CI , 0.45 to 0.62 ; P < .001 , respectively ) , validating the imaging data assay used .


Spearman 's correlation coefficient between rPFS and OS was 0.72 .


rPFS was highly consistent and highly associated with OS , providing initial prospective evidence on further developing rPFS as an intermediate end point in mCRPC trials .


Rehabilitation care is an important part of comprehensive care for MS patients .


Little is known about the number of physiatry residents who are interested in providing care to individuals with multiple sclerosis [ MS ] .


This study examines factors that influence physiatry residents ' interest in providing care to MS patients .


We randomly sampled half of all Accreditation Council for Graduate Medical Education-certified physical medicine and rehabilitation residency programs in the continental United States and Puerto Rico .


Surveys were received from 74 % of programs ( Stage 1 response rate ) and from 221 residents ( 45 % Stage 2 response rate ) .


Residents expressing interest in providing MS care were more likely to be female , Asian , and to select statements emphasizing multidisciplinary care approaches and a community of dedicated professional colleagues as positive features of MS patient care .


Residents interested in teaching and with more education debt were marginally more likely to express interest in MS care .


Medical education should emphasize the need for physical medicine and rehabilitative care among individuals with MS , the ability of physiatrists to improve the functional status and quality of life for MS patients , and the team-based nature of MS care .


Lysine requirements of well-nourished children from developing regions have been found to be similar to those of children from developed regions ( 33.5 mgkgd ) .


However , intestinal parasites have been shown to increase lysine requirements in undernourished adults , and it is not known if a similar phenomenon occurs in undernourished children from poor and unsanitary environments .


Our objective was to measure the lysine requirement of moderately undernourished school-aged Indian children by the indicator amino acid oxidation technique before and after successful treatment for intestinal parasites .


Twenty-one undernourished school-aged children ( 8 y of age ) with z scores between -2 SD and -3 SD for height-for-age or weight-for-age , who tested positive for intestinal parasites , were studied before and after successful antiparasite treatment .


Children were fed any 2 of 7 levels of lysine intakes ( 5 , 15 , 25 , 35 , 50 , 65 , and 80 mgkgd ) in random order .


The lysine requirement was determined by applying a 2-phase linear regression crossover analysis on the fractional oxidation rate of the tracer L - [ 1-C ] phenylalanine in response to the graded lysine intakes .


The lysine requirement of undernourished children with intestinal parasite infestations was determined to be 42.8 mgkgd ( 95 % CI : 32.6 , 53.1 mgkgd ) , and after successful antiparasitic treatment it was determined to be 35.5 mgkgd ( 95 % CI : 25.5 , 45.5 mgkgd ) .


The results were significantly different ( P < 0.05 ) , although the 95 % CIs overlapped .


The lysine requirement in undernourished children is similar to that of well-nourished children , and intestinal parasitic infestation increased the lysine requirement by 20 % .


To compare the efficacy and side effects of low-dose amitriptyline ( AMT ) with proton pump inhibitor treatment in patients with globus pharyngeus .


Thirty-four patients who fulfilled the Rome III criteria for functional esophageal disorders were included in this study .


Patients were randomly assigned to receive either 25 mg AMT before bedtime ( AMT group ) or 40 mg Pantoprazole once daily for 4 wk ( conventional group ) .


The main efficacy endpoint was assessed using the Glasgow Edinburgh Throat Scale ( GETS ) .


The secondary efficacy endpoints included the Medical Outcomes Study 36-item short form health survey [ social functioning ( SF ) -36 ] and the Pittsburgh Sleep Quality Index .


Treatment response was defined as a > 50 % reduction in GETS scores .


All patients entering this study recorded side effects at days 1 , 8 , 15 , 22 and 29 using a visual analogue scale .


Thirty patients completed the study .


After 4 wk of treatment , the AMT group had a greater response than the conventional group ( 75 % vs 35.7 % , P = 0.004 ) .


At day 3 , the AMT group showed significantly more improvement than the Conventional group in GETS score ( 3.69 1.14 vs 5.64 1.28 , P = 0.000 ) .


After 4 wk of treatment , the AMT group showed significantly greater improvement in GETS score and sleep quality than the Conventional group ( 1.25 1.84 vs 3.79 2.33 , 4.19 2.07 vs 8.5 4.97 ; P < 0.01 for both ) .


Additionally , the AMT group was more likely than the Conventional group to experience improvement in the SF-36 , including general health , vitality , social functioning and mental health ( P = 0.044 , 0.024 , 0.049 and 0.005 ) .


Dry mouth , sleepiness , dizziness and constipation were the most common side effects .


Low-dose AMT is well tolerated and can significantly improve patient symptoms , sleep and quality of life .


Thus , low-dose AMT may be an effective treatment for globus pharyngeus .


Up to now , all tested Ebola virus vaccines have been based on the virus strain from the Zaire outbreak in 1976 .


We aimed to assess the safety and immunogenicity of a novel recombinant adenovirus type-5 vector-based Ebola vaccine expressing the glycoprotein of the 2014 epidemic strain .


We did this randomised , double-blind , placebo-controlled , phase 1 clinical trial at one site in Taizhou County , Jiangsu Province , China .


Healthy adults ( aged 18-60 years ) were sequentially enrolled and randomly assigned ( 2:1 ) , by computer-generated block randomisation ( block size of six ) , to receive placebo , low-dose adenovirus type-5 vector-based Ebola vaccine , or high-dose vaccine .


Randomisation was pre-stratified by dose group .


All participants , investigators , and laboratory staff were masked to treatment allocation .


The primary safety endpoint was occurrence of solicited adverse reactions within 7 days of vaccination .


The primary immunogenicity endpoints were glycoprotein-specific antibody titres and T-cell responses at day 28 after the vaccination .


Analysis was by intention to treat .


The study is registered with ClinicalTrials.gov , number NCT02326194 .


Between Dec 28 , 2014 , and Jan 9 , 2015 , 120 participants were enrolled and randomly assigned to receive placebo ( n = 40 ) , low-dose vaccine ( n = 40 ) , or high-dose vaccine .


Participants were followed up for 28 days .


Overall , 82 ( 68 % ) participants reported at least one solicited adverse reaction within 7 days of vaccination ( n = 19 in the placebo group vs n = 27 in the low-dose group vs n = 36 in the high-dose group ; p = 00002 ) .


The most common reaction was mild pain at the injection site , which was reported in eight ( 20 % ) participants in the placebo group , 14 ( 35 % ) participants in the low-dose group , and 29 ( 73 % ) participants in the high-dose vaccine group ( p < 00001 ) .


We recorded no statistical differences in other adverse reactions and laboratory tests across groups .


Glycoprotein-specific antibody titres were significantly increased in participants in the low-dose and high-dose vaccine groups at both day 14 ( geometric mean titre 4214 [ 95 % CI 2497-7113 ] and 8205 [ 5989-11240 ] , respectively ; p < 00001 ) and day 28 ( 6827 [ 4243-10985 ] and 13057 [ 9701-17572 ] , respectively ; p < 00001 ) .


T-cell responses peaked at day 14 at a median of 4650 spot-forming cells ( IQR 1800-12025 ) in participants in the low-dose group and 7650 cells ( 4000-14600 ) in those in the high-dose group .


21 ( 18 % ) participants had mild fever ( n = 9 in the placebo group , n = 6 in the low-dose group , and n = 6 in the high-dose group ) .


No serious adverse events were recorded .


Our findings show that the high-dose vaccine is safe and robustly immunogenic .


One shot of the high-dose vaccine could mount glycoprotein-specific humoral and T-cell response against Ebola virus in 14 days .


China National Science and Technology , Beijing Institute of Biotechnology , and Tianjin CanSino Biotechnology .


To evaluate the thermal antinociceptive effects and duration of action of buprenorphine hydrochloride after IM administration to American kestrels ( Falco sparverius ) .


12 healthy 3-year-old American kestrels .


Buprenorphine hydrochloride ( 0.1 , 0.3 , and 0.6 mg/kg ) and a control treatment ( saline [ 0.9 % NaCl ] solution ) were administered IM in a randomized crossover experimental design .


Foot withdrawal response to a thermal stimulus was determined 1 hour before ( baseline ) and 1.5 , 3 , and 6 hours after treatment administration .


Agitation-sedation scores were determined 3 to 5 minutes before each thermal stimulus .


Adverse effects were monitored for 6 hours after treatment administration .


Buprenorphine hydrochloride at 0.1 , 0.3 , and 0.6 mg/kg , IM , increased thermal threshold for 6 hours , compared with the response for the control treatment .


There were no significant differences among buprenorphine treatments .


A mild sedative effect was detected at a dose of 0.6 mg of buprenorphine/kg .


At the doses tested , buprenorphine hydrochloride resulted in thermal antinociception in American kestrels for at least 6 hours , which suggested that buprenorphine has analgesic effects in this species .


Further studies with longer evaluation periods and additional forms of noxious stimuli , formulations , dosages , and routes of administration are needed to fully evaluate the analgesic effects of buprenorphine in American kestrels .


Patellofemoral pain syndrome ( PFPS ) is a common musculoskeletal condition , particularly among women .


Patients with PFPS usually experience weakness in the gluteal muscles , as well as pain and impaired motor control during activities of daily living .


Strengthening the hip muscles is an effective way of treating this disorder .


Neuromuscular training has also been identified as a therapeutic tool , although the benefits of this intervention in patients with PFPS patients remain inconclusive .


This is a protocol of randomized controlled trial with a blind assessor .


Thirty-four women with a clinical diagnosis of PFPS participated .


These participants were allocated into two groups ( experimental and control ) .


The experimental group performed twelve sessions to strengthen the knee extensors , hip abductor and lateral rotator muscles in association with neuromuscular training of the trunk and lower extremities .


The control group performed the same number of sessions to strengthen the muscles of the hip and knee .


The primary outcome was functional capacity ( Anterior Knee Pain Scale - AKPS ) at 4weeks .


Pain intensity , muscle strength and kinematic changes were also measured during the step down test after four weeks of intervention .


Follow up assessments were conducted after three and six months to assess functional capacity and pain .


The effects of the treatment ( i.e. between-group differences ) were calculated using mixed linear models .


The present study was initiated on the 1st of April 2013 and is currently in progress .


The results of this study may introduce another effective technique of conservative treatment and could guide physical therapists in the clinical decision-making process for women with PFPS .


Current Controlled Trials NCT01804608 .


The objective of this study was to evaluate the effect of nasal packing , septal suture technique and vacuum sealing drainage ( VSD ) after septoplasty .


Ninety patients of nasal septal deviation in Combination with outfracture of the inferior turbinates who had received septoplasty were selected in this study .


The patients were allocated into three groups , with thirty in each : for packing group , marcel materials were used for nasal packing after septoplasty ; for suturing group , septal suture technique was performed after septoplasty ; for VSD group , one drainage tube was used for negative pressure sucking after septoplasty without nasal packing .


Postoperative signs and symptoms were compared between three groups .


The comfort degree assessment included headache and nasal obstruction were evaluated by using visual analogue scale ( VAS ) at the 12th hour and 24 hour after operation .


The edema in nasal cavity , hemorrhage .


abscess , adhesive and healing rates after operation were compared among three groups .


The VAS score of headache and nasal obstruction and the severity of patient 's conditions were significantly less in septal suture group and VSD group than that in packing group at the 12th and 24th hour after operation .


The mucosa edema of nasal cavity was significantly slighter in septal suture group and VSD group than that in packing group at the third day after operation .


The healing rates and number of complications are better in septal suture group and VSD group than those in packing group at the 7th day after operation .


There were no hemorrhage or abscess in VSD group .


Septal suture technique and VSD after septoplasty can significantly relieve the distress of patients and reduce the healing time of mucosa in nasal cavity without increasing the risk of complications .


To investigate baseline predictors of month 24 best-corrected visual acuity ( BCVA ) and central foveal thickness ( CFT ) in patients with diabetic macular edema ( DME ) treated monthly with ranibizumab or sham .


Post hoc analysis of DME patients in 2 identical phase 3 studies .


Patients randomized to ranibizumab ( n = 502 ) or sham ( n = 257 ) .


Multivariate regression on predictors with P < 0.20 in univariate logistic regression using backward selection to retain predictors with P < 0.05 .


Patient characteristics correlating with month 24 BCVA in Early Treatment Diabetic Retinopathy Study letter score 70 ( 20/40 ) or 50 ( 20/100 ) , gain or loss from baseline BCVA of 15 , or CFT 250 m.


Baseline predictors of BCVA 20/40 in ranibizumab-treated patients were good BCVA , submacular fluid , no cardiovascular disease , no scatter photocoagulation , and male gender , whereas in sham-treated patients , they were mild increase in CFT , presence of hard exudates in center subfield , and absence of renal disease .


Predictors of improvement in BCVA letter score 15 in ranibizumab-treated patients were poor BCVA , submacular fluid , young age , and short diabetes duration , and those in sham-treated patients were poor BCVA , young age , and mild increase in CFT .


Predictors of resolution of edema ( CFT 250 m ) in ranibizumab-treated patients were mild foveal thickening and prominent subfoveal fluid , and those in sham-treated patients were poor BCVA , mild foveal thickening , and statin usage .


Month 24 BCVA 20/100 was predicted by poor baseline BCVA in ranibizumab-treated patients , and by poor baseline BCVA , large intraretinal cystoid spaces , renal disease , and absence of hypercholesterolemia in sham-treated patients .


Loss of BCVA 15 letters was predicted in sham-treated patients by submacular fluid , intraretinal cystoid spaces , and renal disease .


Patients with DME and submacular fluid , intraretinal cysts , severe thickening , or renal disease respond poorly when untreated and respond well to ranibizumab treatment .


Elimination of submacular fluid , intraretinal cysts , and severe thickening are important goals of DME treatment , and in patients with renal disease , treatment should be very aggressive , with a goal of eliminating all macular fluid .


This study included 54-month-old children with a history of institutional care .


Our goal was to : ( 1 ) examine differences in indiscriminate social behaviors in children with a history of institutional care compared with home-reared children ; ( 2 ) test whether foster care reduces indiscriminate social behaviors in a randomized controlled trial ; and ( 3 ) examine early predictors of indiscriminate behaviors .


Participants were 58 children with a history of institutional care and 31 never-institutionalized control ( NIG ) subjects enrolled in a randomized controlled trial of foster care for institutional care , assessed from toddlerhood to 54 months .


Indiscriminate social behaviors were measured naturalistically by using the Stranger at the Door procedure .


In the Stranger at the Door procedure , children with a history of institutional care left with a stranger at higher rates than NIG subjects ( 33 % vs. 3.5 % ; P < .001 ) .


Children in the care as usual group left more than NIG subjects ( 41.9 % vs. 3.6 % ; P .001 ) .


The differences between the foster care group ( 24.1 % ) and the care as usual group and between foster care group and NIG were not significant .


In a logistic regression , early disorganized attachment behaviors , baseline developmental quotient , and caregiving quality after randomization contributed to variance at 54 months .


In the same analysis using only children with a history of institutional care , only disorganized attachment contributed significantly to 54-month indiscriminate social behaviors ( Exp [ B ] = 1.6 [ 95 % confidence interval : 1.1-2 .5 ] ) .


Observed socially indiscriminate behaviors at 54 months were associated with prolonged exposure to institutional care .


Young children raised in conditions of deprivation who fail to develop organized attachments as toddlers are at increased risk for subsequent indiscriminate behaviors .


One goal of guideline-based asthma therapy is minimal use of short-acting agonist ( SABA ) medications .


Inner-city children with asthma are known to have high SABA use .


To examine factors associated with high SABA use in inner-city children with asthma .


One hundred inner-city children with persistent asthma were enrolled into a randomized controlled trial of an emergency department ( ED ) and home intervention .


All children underwent serologic allergen specific IgE and salivary cotinine testing at the ED enrollment visit .


Pharmacy records for the past 12 months were obtained .


Number of SABA fills during the past 12 months was categorized into low - to moderate - vs high-use groups .


SABA groups were compared by the number of symptom days and nights , allergen sensitization , and exposures .


Regression models were used to predict high SABA use .


Mean number of SABA fills over 12 months was 3.12 .


Unadjusted bivariate analysis showed that high SABA users were more than 5 times more likely to have an asthma hospitalization , almost 3 times more likely to have an asthma intensive care unit admission , and more than 3 times more likely to have prior specialty asthma care or positive cockroach sensitization than low to moderate SABA users .


In the final regression model , for every additional inhaled corticosteroid fill , a child was 1.4 times more likely and a child with positive cockroach sensitization was almost 7 times more likely to have high SABA use when controlling for prior intensive care unit admission , receipt of specialty care , child age , and income .


Providers should closely monitor SABA and controller medication use , allergen sensitization , and exposures in children with persistent asthma .


ClinicalTrials.gov , identifier NCT01981564 .


To compare the cardiopulmonary effects of intravenous ( IV ) and intramuscular ( IM ) medetomidine and butorphanol with or without MK-467 .


Prospective , randomized experimental cross-over .


Eight purpose-bred beagles ( two females , six males ) , 3-4 years old and weighing 14.5 1.6 kg ( mean SD ) .


All dogs received four different treatments as follows : medetomidine 20 g kg ( -1 ) and butorphanol tartrate 0.1 mg kg ( -1 ) IV and IM ( MB ) , and MB combined with MK-467 ,500 g kg ( -1 ) ( MBMK ) IV and IM .


Heart rate ( HR ) , arterial blood pressures ( SAP , MAP , DAP ) , central venous pressure ( CVP ) , cardiac output , respiratory rate ( fR ) , rectal temperature ( RT ) were measured and arterial blood samples were obtained for gas analysis at baseline and at 3 , 10 , 20 , 30 , 45 and 60 minutes after drug administration .


The cardiac index ( CI ) , systemic vascular resistance index ( SVRI ) and oxygen delivery index ( DO2 I ) were calculated .


After the follow-up period atipamezole 50 g kg ( -1 ) IM was given to reverse sedation .


HR , CI and DO2 I were significantly higher with MBMK after both IV and IM administration .


Similarly , SAP , MAP , DAP , CVP , SVRI and RT were significantly lower after MBMK than with MB .


There were no differences in fR between treatments , but arterial partial pressure of oxygen decreased transiently after all treatments .


Recoveries were uneventful following atipamezole administration after all treatments .


MK-467 attenuated the cardiovascular effects of a medetomidine-butorphanol combination after IV and IM administration .


To evaluate adherence to therapy in acne patients using mobile phones and Short Message Service ( SMS ) to communicate .


160 patients were randomly assigned to two groups : the SMS group received 2 text messages twice a day for a period of 12 weeks ; the control group did not receive any messages .


Before and after 12 weeks , the following evaluations were performed in all patients : digital photographs , the Global Acne Grading System , the Dermatology Life Quality Index , the Cardiff Acne Disability Index , the doctor-patient relationship evaluated through the Patient-Doctor Depth-of-Relationship Scale , and the adherence to treatment evaluated by asking patients how many days a week they had followed the therapy .


For statistical analysis we used Student 's t test .


The SMS group had a better improvement of all parameters compared to the control group .


Adherence and compliance are higher for patients who are included in a strategy of control .


Ondansetron , sometimes combined with acustimulation at PC6 ( Neiguan ) , is commonly used for preventing postoperative nausea and vomiting , but PC6 is not the only point that can be used for this purpose .


To evaluate the combined effects of ondansetron and ST36 ( Zusanli ) acupuncture point injection on postoperative vomiting ( POV ) after laparoscopic surgery .


A randomised , patient and assessor-blinded , placebo-controlled clinical study was conducted .


One hundred and sixty patients undergoing laparoscopic surgery were randomly assigned to one of four groups : ( 1 ) group P ( placebo-control ) : intravenous normal saline + bilateral non-acupuncture point injection of vitamin B1 ( n = 40 ) ; ( 2 ) group O ( ondansetron ) : intravenous ondansetron + bilateral ST36 sham injection ( n = 40 ) ; ( 3 ) group A ( acupuncture point injection ) : intravenous normal saline + bilateral acupuncture point injection at ST36 of vitamin B1 ( n = 40 ) ; ( 4 ) group C ( combination ) : intravenous ondansetron + bilateral acupuncture point injection at ST36 of vitamin B1 ( n = 40 ) .


Interventions were made on arrival at the postanaesthesia care unit .


The primary outcome was the incidence of POV within 24 h after the operation .


Secondary outcomes included severity of vomiting , incidence of rescue treatment , patients ' satisfaction and the first anal exsufflation time 24 h after the operation .


The incidence of POV within 24 h postoperative period in each group was P 33 % ; O 11 % , A 9 % and C 6 % .


Outcomes for all intervention groups were significantly better than that for placebo ( p < 0.01 ) .


For the three interventions compared with placebo , the numbers needed to treat ( NNTs ) were O , NNT = 5 ; A , NNT = 5 and C , NNT = 4 .


The secondary outcomes also demonstrated greater benefits of the combined regimen , with improvement seen in all the measures .


Ondansetron , acupuncture , and ondansetron and acupuncture combined are effective prophylaxis for POV .


The impact of sugar-sweetened beverages ( SSB ) on lipid metabolism when consumed in moderate amounts by normal weight subjects is debated .


The objective of the study was to investigate the effect of different types of sugars in SSB on fatty acid metabolism ( ie , fatty acid synthesis and oxidation ) in healthy young men .


Thirty-four normal-weight men were studied in a randomized crossover study .


Four isocaloric 3-week interventions with SSB were performed in random order : medium fructose ( MF ; 40 g/d ) ; high fructose ( HF ; 80 g/d ) , high sucrose ( HS ; 80 g/d ) , and high glucose ( HG ; 80g/d ) .


Fasting total plasma fatty acid composition was measured after each intervention .


Acylcarnitines were measured in the fasting state and after a euglycemic hyperinsulinemic clamp in nine subjects .


The relative abundance of palmitate ( 16:0 ) and the molar fatty acid ratio of palmitate to linoleic acid ( 16:0 to18 :2 ) as markers of fatty acid synthesis were increased after HF [ relative abundance of palmitate : 22.97 % 5.51 % ( percentage of total fatty acids by weight SD ) ] and MF ( 26.1 % 1.7 % ) compared with HS ( 19.40 % 2.91 % , P < .001 ) , HG ( 19.43 % 3.12 % , P < .001 ) , or baseline ( 19.40 % 2.79 % , P < .001 ) .


After HS and HG , the relative abundance of palmitate was equal to baseline .


Fasting palmitoylcarnitine was significantly increased after HF and HS ( HF and HS vs. HG : P = .005 ) , decreasing after inhibition of lipolysis by insulin in the clamp .


When consumed in moderate amounts , fructose but not sucrose or glucose in SSB increases fatty acid synthesis ( palmitate ) , whereas fasting long-chain acylcarnitines are increased after both fructose and sucrose , indicating an impaired - oxidation flux .


Little is known about global patterns of critical care unit ( CCU ) care and the relationship with outcomes in patients with acute decompensated heart failure ( ADHF ) .


Whether a ward or a CCU admission is associated with better outcomes is unclear .


Patients in the Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure ( ASCEND-HF ) trial were initially hospitalized in a ward or CCU ( coronary or intensive care unit ) .


Sites were geographically classified : Asia-Pacific ( AP ) , Central Europe ( CE ) , Latin America ( LA ) , North America ( NA ) , and Western-Europe ( WE ) .


The primary outcome of 30-day all-cause mortality or all-cause hospital readmission was adjusted using a two-stage multivariable logistic regression model with a generalized estimated equation that took sites within each country as a nested random factor .


Overall , 1944 ( 38.2 % ) patients were admitted to a CCU and 3150 ( 61.8 % ) to a ward , and this varied by region : 50.6 % AP , 63.3 % CE , 60.7 % WE , 22.1 % LA , and 28.6 % NA .


The 30-day death or readmission rate was 15.2 % in ward patients and 17.0 % in CCU patients ( risk-adjusted Odds Ratio [ OR ] 1.44 : 95 % CI , 1.14-1 .82 ) .


Compared with CCU patients in NA ( 24.1 % 30-day event rate ) , the primary outcomes were : AP ( 10.4 % , Odds Ratio [ OR ] 0.63 ; 95 % confidence Interval [ CI ] , 0.35 to 1.15 ) , CE ( 10.4 % , OR 0.56 : 95 % CI , 0.31 to 1.02 ) , LA ( 22.4 % , OR 0.60 : 95 % CI , 0.11 to 3.32 ) , and WE ( 11.2 % , OR 0.63 , 95 % CI , 0.25 to 1.56 ) .


No regional differences in 30-day mortality were observed ; however , 30-day readmission rates were highest in NA sites .


Management of patients with ADHF varies significantly , and after adjustment , CCU care was associated with higher risk of early mortality , not explained by international differences .


These findings may help to improve the early decisions regarding risk stratification of patients hospitalized with ADHF .


Hand-foot syndrome ( HFS ) is a frequently occurring adverse event associated with anticancer drugs .


This study compares a newly introduced ointment containing several antioxidants and exhibiting high radical protection factor , which has been available on the German market since 2011 , with urea cream for prevention of HFS in patients treated with capecitabine .


Patients with GI tumors or breast cancer treated with capecitabine were included in this randomized phase III study .


The primary end point was prevention of HFS of any grade within 6 weeks of treatment as indicated by a standardized patient diary .


The study had 80 % power to show a 20 % reduction of the incidence of HFS with the new ointment .


Secondary end points included time to development of HFS greater than grade 1 , evaluation of capecitabine dose intensity , and quality of life analyses .


A total of 152 patients were evaluable .


In total , 47 of 152 patients experienced HFS ( 30.9 % ) , 39.5 % with the new ointment and 22.4 % in the urea arm ( stratified odds ratio , 2.37 ; P = .02 ) .


Time to HFS greater than grade 1 was comparable , but time to any-grade HFS was significantly longer in the urea group ( P = .03 ) .


Capecitabine dose intensity , time under study , and percentage of days with correct administration of study medication were identical , as were adverse events except for HFS .


Skin-related quality of life was significantly worse in the group treated with the new ointment at the end of study treatment .


This trial demonstrated that 10 % urea cream was superior to the new ointment at preventing HFS over the first 6 weeks of treatment with capecitabine .


Atrial fibrillation ( AFib ) is common in heart failure ( HF ) with preserved ejection fraction ( HFpEF ) .


Current AFib stroke risk prediction models include the presence of HF but do not specifically include HFpEF as a risk factor .


Whether a history of AFib should be used to identify patients with HFpEF who are at risk has not been established .


Baseline characteristics and outcomes of patients with HFpEF in the Irbesartan in Heart Failure with Preserved Ejection Fraction Trial were analyzed in relation to AFib .


At baseline , 1209 ( 29.3 % ) had a history of AFib .


Of these 557 ( 13.5 % ) had history of AFib alone , whereas 670 ( 16.2 % ) had both a history and AFib on ECG ; 2901 ( 70.3 % ) had neither .


There were no significant differences in the risk of stroke between the 2 groups with a history of AFib who did or did not have AFib present on baseline ECG .


During a median follow-up of 53 months , a fatal or nonfatal stroke occurred in 6.5 % ( 79/1209 ) patients with history of AFib compared with 3.9 % ( 114/2901 ) with no AFib .


Having a history of AFib was independently associated with higher risk of stroke ( hazard ratio , 2.2 ; 95 % confidence interval , 1.6-3 .2 ; P < 0.0001 ) compared with those with no history of AFib .


In patients with HFpEF , a history of AFib was common and independently associated with increased risk of stroke , regardless of whether AFib was present on ECG .


Patients with HFpEF and a history of AFib should be considered at risk .


Further studies are needed to determine whether this risk can be safely reduced .


http://www.clinicaltrials.gov .


Unique identifier : NCT000095238 .


Selective kappa opioid receptor antagonism is a promising experimental strategy for the treatment of depression .


The kappa opioid receptor antagonist , LY2456302 , exhibits ~ 30-fold higher affinity for kappa opioid receptors over mu opioid receptors , which is the next closest identified pharmacology .


Here , we determined kappa opioid receptor pharmacological selectivity of LY2456302 by assessing mu opioid receptor antagonism using translational pupillometry in rats and humans .


In rats , morphine-induced mydriasis was completely blocked by the nonselective opioid receptor antagonist naloxone ( 3mg/kg , which produced 90 % mu opioid receptor occupancy ) , while 100 and 300 mg/kg LY2456302 ( which produced 56 % and 87 % mu opioid receptor occupancy , respectively ) only partially blocked morphine-induced mydriasis .


In humans , fentanyl-induced miosis was completely blocked by 50mg naltrexone , and LY2456302 dose-dependently blocked miosis at 25 and 60 mg ( minimal-to-no blockade at 4-10mg ) .


We demonstrate , for the first time , the use of translational pupillometry in the context of receptor occupancy to identify a clinical dose of LY2456302 achieving maximal kappa opioid receptor occupancy without evidence of significant mu receptor antagonism .


To compare the efficacy of an acupuncture regimen for persistent allergic rhinitis ( PER ) , aimed at improving a patient 's mind or Shen in Traditional Chinese Medicine , to that of a second-generation Hi-receptor antagonist , cetirizine hydrochloride .


This multicenter , randomized , controlled clinical trial on PER will be conducted at three institutions in China .


The total study period will be 9 weeks .


After a 1-week preparatory screening period , 240 eligible participants with PER will be randomized to receive acupuncture or pharmacotherapy ( 1:1 ) for 4 weeks with a 4-week follow-up .


The primary outcome will be changes in 7-day average total nasal symptom score .


Secondary outcome measures include rhinoconjunctivitis quality of life questionnaire score and total non-nasal symptom score .


The presence and seriousness of psychological and emotional impairments should be considered in therapeutic programs for allergic rhinitis .


No clinical trial for treating allergic rhinitis via acupuncture regulation of psychological and emotional activities has been reported .


The findings of the trial will allow us to determine the effects of the mind ( Shen ) - regulation treatment approach .


We will also be able to confirm if the effects of acupuncture are equivalent to those of the conventional drug cetirizine hydrochloride .


Probiotics are microbial supplements that have shown efficacy in a wide range of applications .


To assess the safety and effects of enteral probiotics in critically ill neonates .


A double-blind , randomized controlled trial was conducted in 100 full-term infants with critical illness according to scores of neonatal acute physiology .


Fifty neonatal intensive care patients were randomly assigned to receive probiotics three times daily after birth for 8 days , and fifty patients were not given probiotics , but who received a placebo .


The incidence of sepsis , multiple organ dysfunction syndrome ( MODS ) , nosocomial pneumonia , and necrotizing enterocolitis were recorded .


The prognosis of probiotic treatment was determined based on the rate of recovery and hospital days .


Serum IgA , IgG , and IgM concentrations were measured on days 4 and 8 .


Infants in the probiotics group showed a significantly reduced rate of nosocomial pneumonia ( 18 % versus 36 % ) and multiple organ dysfunction syndrome ( 6 % versus 16 % ) compared with the placebo group ( p < 0.05 ) .


Significant results were demonstrated in favour of the probiotics for days of hospital stay ( 13 3.5 d versus 15.8 5.3 d ) ( p < 0.05 ) .


However , there were no significant differences in the occurrence of sepsis , necrotizing enterocolitis , and recovery rate .


Patients given probiotics had significantly greater levels of IgA than those in the placebo group ( p < 0.05 ) .


No serious adverse effects in the study population were noted .


Supplements of probiotics to critically ill neonates could enhance immune activity , decrease occurrence of nosocomial pneumonia and MODS , and reduce days in hospital .


Recently , there have been investigations that have targeted improving the relatively poor validity and reliability of attentional bias measures .


These studies have demonstrated that individuals show elevated attentional bias to stimuli associated with their drinking history , although to date , the predictive utility of these measures has yet to be assessed .


The current study aimed to investigate the predictive value of an individualised alcohol Stroop task compared to that of an alcohol Stroop task with general alcohol-related words in a sample of non-dependent undergraduate drinkers .


48 undergraduate social drinkers completed questionnaire measures of alcohol consumption and hazardous drinking which were combined to get an alcohol involvement measure .


Participants also completed three blocked format Stroop tasks , a control Stroop ( containing soft drink-related words ) , a general alcohol Stroop ( containing a mixture of alcohol-related words ) and an individualised Stroop that contained words relating to the participants ' favourite alcoholic drink .


Although there was no significant difference in participants ' performance across the three different Stroop tasks , only performance on the individualised Stroop was associated with alcohol involvement .


Notably , the individualised Stroop predicted variance in drinking after controlling for demographics and general alcohol Stroop performance .


This study indicates that adopting individualised stimuli into attentional bias tasks may increase their predictive validity .


Following acute coronary syndrome ( ACS ) , the risk for future cardiovascular events is high and is related to levels of low-density lipoprotein cholesterol ( LDL-C ) even within the setting of intensive statin treatment .


Proprotein convertase subtilisin/kexin type 9 ( PCSK9 ) regulates LDL receptor expression and circulating levels of LDL-C .


Antibodies to PCSK9 can produce substantial and sustained reductions of LDL-C .


The ODYSSEY Outcomes trial tests the hypothesis that treatment with alirocumab , a fully human monoclonal antibody to PCSK9 , improves cardiovascular outcomes after ACS .


This Phase 3 study will randomize approximately 18,000 patients to receive biweekly injections of alirocumab ( 75-150 mg ) or matching placebo beginning 1 to 12 months after an index hospitalization for acute myocardial infarction or unstable angina .


Qualifying patients are treated with atorvastatin 40 or 80 mg daily , rosuvastatin 20 or 40 mg daily , or the maximum tolerated and approved dose of one of these agents and fulfill one of the following criteria : LDL-C 70 mg/dL , non-high-density lipoprotein cholesterol 100 mg/dL , or apolipoprotein B 80 mg/dL .


The primary efficacy measure is time to first occurrence of coronary heart disease death , acute myocardial infarction , hospitalization for unstable angina , or ischemic stroke .


The trial is expected to continue until 1613 primary end point events have occurred with minimum follow-up of at least 2 years , providing 90 % power to detect a 15 % hazard reduction .


Adverse events of special interest include allergic events and injection site reactions .


Interim analyses are planned when approximately 50 % and 75 % of the targeted number of primary end points have occurred .


ODYSSEY Outcomes will determine whether the addition of the PCSK9 antibody alirocumab to intensive statin therapy reduces cardiovascular morbidity and mortality after ACS .


Intrauterine growth restriction may be reduced by supplementing maternal diets during pregnancy , but few studies have assessed the impact of combined prenatal and postnatal interventions on child growth .


We tested a hypothesis that provision of small-quantity lipid-based nutrient supplements ( SQ-LNSs ) to mothers in pregnancy and 6 mo postpartum and to their infants from 6 to 18 mo of age would promote infant and child growth in the study area in rural Malawi .


We enrolled 869 pregnant women in a randomized trial in Malawi .


During pregnancy and 6 mo thereafter , the women received daily 1 capsule of iron-folic acid ( IFA ) , 1 capsule containing 18 micronutrients ( MMN ) , or one 20-g sachet of SQ-LNS [ lipid-based nutrient supplements ( LNS ) , containing 21 MMN , protein , carbohydrates , essential fatty acids , and 118 kcal ] .


Children in the IFA and MMN groups received no supplementation ; children in the LNS group received SQ-LNSs from 6 to 18 mo. .


Primary outcome was child length at 18 mo. .


At 18 mo , the mean length in the IFA , MMN , and LNS groups was 77.0 , 76.9 , and 76.8 cm ( P = 0.90 ) , respectively , and the prevalence of stunting was 32.7 % , 35.6 % , and 37.9 % ( P = 0.54 ) , respectively .


No intergroup differences were found in the mean weight , head circumference , or midupper arm circumference or the proportions with low z scores for these variables ( P > 0.05 ) .


Covariate adjustment did not change the analysis results , and the associations between the intervention and child length were not modified by maternal parity , age , or nutritional status ( P > 0.10 ) .


The findings do not support a hypothesis that provision of SQ-LNSs to women in pregnancy and postpartum and to children from 6 to 18 mo of age would promote child growth in this Malawian study area .


This trial was registered at clinicaltrials.gov as NCT01239693 .


Femoral nerve block ( FNB ) with varying concentrations of bupivacaine is often used for postoperative analgesia after anterior cruciate ligament ( ACL ) reconstruction .


To determine whether FNB using 0.25 % or 0.5 % bupivacaine provided better analgesia with less effect on quadriceps strengths after ACL reconstruction .


One hundred patients were randomized to receive FNB with 20 mL of 0.25 % or 0.5 % bupivacaine .


Data regarding demographic , effectiveness of FNB , time to first pain , time to first analgesic , pain scores , morphine use , and recovery of sensory and motor function were recorded .


Median time to first morphine requirement was 12 hours in 0.5 % bupivacaine group and 10 hours in 0.25 % bupivacaine group ( p = 0.048 ) .


Pain score at 18 hours was lower in 0.5 % bupivacaine group compared with 0.25 % bupivacaine group ( p = 0.001 ) .


When specify to the patellar tendon graft subgroup , the patients requiring morphine were 70 % in 0.5 % bupivacaine group and 90 % in 0.25 % bupivacaine group ( p = 0.03 ) .


No differences were found in demographic data , effectiveness of FNB , time to first pain , morphine consumption , and recovery of sensorimotor function .


FNB with 0.5 % bupivacaine provided longer time to first analgesic and lower narcotic requirements after patellar tendon graft ACL reconstruction when compared to 0.25 % bupivacaine .


Both concentrations showed similar effect on quadriceps strengths .


To establish a preoperative deep venous thrombosis predictor score for patients with fresh lower extremity fractures by statistical analysis .


From January 2011 to December 2012 , 1 705 patients with fresh lower extremity fractures were admitted to department of orthopaedic trauma , Beijing Jishuitan Hospital .


They were randomly divided into two groups , the group 1 ( n = 879 ) was used to screen risk factors and derived a predictive models based on logistic regression , the group 2 ( n = 826 ) validated the models .


Among the patients , there were 1 106 male and 599 female patients , with an average age of ( 50 18 ) years.Variables related to preoperative deep venous thrombosis were age , length of time before surgery , cause of injury , low/high-energy injury , location of injury , history of cardiovascular and cerebrovascular diseases , and D-Dimer .


The scores based on OR were : age 35 years : 1 point , > 35 - < 65 years : 4 points , 65 years : 6 points ; length of time before surgery , < 8 days :1 point , 8 days :2 points ; low-energy injury :1 point , high energy injury :3 points ; location of injury , foot and ankle :1 point , calf :3 points , around the knee : 5 points , femoral diaphysis and proximal femur :7 points , pelvis and acetabulum :4 points , 2 sites :6 point ; history of cardiovascular and cerebrovascular diseases , yes :2 points , no :1 point .


D-Dimer < 600 g/L :1 point , 600 g/L :3 points .


Area under receiver operating characteristic curve was 0.79 , critical point 15.5 points , sensitivity was 77.00 % , specificity was 68.17 % .


The score can predict the preoperative deep venous thrombosis for patients with fresh lower extremity fractures , but limited .


To investigate if baseline depression moderated response to Media Smart , an 8-lesson school-based program previously found to achieve a long-term risk reduction effect in young adolescents .


540 Grade 8 students ( M age = 13.62 years , SD = .37 ) from 4 schools participated with 11 classes receiving the Media Smart program ( 126 girls ; 107 boys ) and 13 comparison classes receiving their normal lessons ( 147 girls ; 160 boys ) .


Shape and weight concern , media internalization , body dissatisfaction , dieting , ineffectiveness , and perceived pressure were the outcome variables .


Moderation was indicated by significant interaction effects for group ( Media Smart ; Control ) moderator ( high depression ; low depression ) time ( post-program ; 6-month follow-up ; 2.5-year follow-up ) , with baseline entered as a covariate .


Such effects were found for shape and weight concern , media internalization , body dissatisfaction , ineffectiveness and perceived pressure .


Post-hoc testing found high depression Media Smart participants scored significantly lower than their control counterparts at post-program on shape and weight concern , media internalization and dieting , whereas low depression Media Smart participants scored significantly lower on shape and weight concern at 2.5-year follow-up .


Media Smart achieved a reduction in eating disorder risk factors for high-depression participants and a reduced rate of growth in risk factor scores for low-depression participants .


Trial registry name : Australian New Zealand Clinical Trials Registry .


URL : http://www.anzctr.org.au .


Registration identification number : ACTRN12608000545369 .


The purpose of this study was to determine the effects of early outpatient exercise on muscle mass , function , and fractional synthetic rate in severely burned children .


Forty-seven children with 40 % total body surface area burn performed a 12-wk standard of care rehabilitation ( SOC , n = 23 ) or rehabilitative exercise training ( RET , n = 24 ) immediately after hospital discharge .


Dual-energy x-ray absorptiometry was used to assess lean body mass ( LBM ) at discharge , posttreatment , and 12 months post-burn .


Muscle function was evaluated with a Biodex Isokinetic Dynamometer , and peak aerobic fitness ( VO2peak ) was measured using a modified Bruce treadmill protocol posttreatment .


Stable isotope infusion studies were performed in a subset of patients ( SOC , n = 13 ; RET , n = 11 ) at discharge and posttreatment to determine mixed-muscle fractional synthetic rate .


Relative peak torque ( RET , 138 9 Nmkg , vs SOC , 106 9 Nmkg ) and VO2peak ( RET , 32 1 mLkgmin , vs SOC , 28 1 mLkgmin ) were greater at posttreatment with RET compared with those with SOC .


In addition , RET increased whole-body ( 9 % 2 % ) and leg ( 17 % 3 % ) LBM compared with SOC .


Furthermore , the percentage change in whole-body ( 18 % 3 % ) and leg ( 31 % 4 % ) LBM from discharge to 12 months post-burn was greater with RET compared to SOC .


Muscle fractional synthetic rate decreased from discharge to posttreatment in both groups ( 6.9 % 1.1 % per day vs 3.4 0.4 % per day ) ; however , no differences were observed between treatment groups at each time point .


Early outpatient exercise training implemented at hospital discharge represents an effective intervention to improve muscle mass and function after severe burn injury .


This study compared generalized complex fractionated atrial electrograms ( CFAE ) ablation versus a selective CFAE ablation strategy targeting areas of continuous electric activity .


Subjects with symptomatic , persistent/high-burden paroxysmal atrial fibrillation ( AF ) were enrolled at 6 centers ( n = 86 ) and randomized to 1 of 2 arms .


For group I , all CFAE regions with an interval confidence level > 7 were ablated followed by pulmonary vein isolation ( PVI ) .


For group II , only CFAE sites with continuous electric activity were ablated followed by PVI .


For PVI , all 4 PV antra were isolated with confirmed entrance block .


Subjects were followed for 1 year with a visit , ECG , and 48-hour Holter every 3 months .


Symptoms were confirmed by loop recording .


The primary end point was freedom from arrhythmia > 30 seconds at 1 year .


For both group I and II , CFAE ablation prolonged AF cycle length ( 2533 versus 2333 ms ; P = 0.78 ) and resulted in similar rates of AF termination ( 37 % versus 28 % ; P = 0.42 ) .


Radiofrequency duration during CFAE ablation was significantly less in group II ( 2320 versus 3820 minutes ; P = 0.002 ) .


At 1-year follow-up , freedom from AF/atrial flutter/atrial tachycardia recurrence was significantly higher in group I versus group II after 1 procedure ( 50 % versus 28 % ; P = 0.03 ) .


There were also significantly fewer repeat procedures in group I ( 13 % versus 36 % ; P = 0.021 ) .


Continuous electric activity ablation + PVI result in a similar incidence of acute AF termination with significantly less radiofrequency time .


However , incidence of repeat procedures and long-term recurrence of AF/atrial flutter/atrial tachycardia are significantly lower using generalized CFAE ablation + PVI .


Clinical Trial Registration - URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00926783 .


To determine if the use of a Bakri balloon at cesarean delivery ( CD ) for placenta previa is associated with a reduced need for additional surgical or pharmacologic measures and less blood loss than usual practices .


In a randomized controlled trial , 52 women undergoing CD for placenta previa were randomly allocated 1:1 into an intervention arm ( prophylactic Bakri balloon immediately following placental delivery ) or a control arm ( use of any usual surgical/pharmacologic measures to achieve hemostasis ) .


The primary outcomes were a clinician 's decision to undertake further intervention to control bleeding , and the difference between preoperative and postoperative hemoglobin levels .


Although fewer women in the intervention group required additional measures to achieve hemostasis during CD , the difference between the groups was not significant ( relative risk 0.54 ; 95 % confidence interval , 0.19-1 .57 ) .


The change in hemoglobin level among women in the intervention arm was also similar to that among controls ( 2.3 g/dL ; 95 % confidence interval , -4.4 to 8.9 ) .


The prophylactic use of a Bakri balloon at CD for placenta previa tended to be of benefit , with no evidence of harm or patient dissatisfaction , but the need for additional medical/surgical measures to control blood loss was not significantly reduced .


Australian New Zealand Clinical Trials Registry : ACTRN12613000348752 .


Exercise training is recommended for chronic heart failure ( HF ) patients to improve functional status and reduce risk of adverse outcomes .


Elevated plasma levels of amino-terminal pro-brain natriuretic peptide ( NT-proBNP ) , high-sensitivity C-reactive protein ( hs-CRP ) , and cardiac troponin T ( cTnT ) are associated with increased risk of adverse outcomes in this patient population .


Whether exercise training leads to improvements in biomarkers and how such improvements relate to clinical outcomes are unclear .


Amino-terminal pro-brain natriuretic peptide , hs-CRP , and cTnT levels were assessed at baseline and 3 months in a cohort of 928 subjects from the HF-ACTION study , a randomized clinical trial of exercise training versus usual care in chronic HF patients with reduced left ventricular ejection fraction ( < 35 % ) .


Linear and logistic regressions were used to assess 3-month biomarker levels as a function of baseline value , treatment assignment ( exercise training vs usual care ) , and volume of exercise .


Linear regression and Cox proportional hazard modeling were used to evaluate the relations between changes in biomarker levels and clinical outcomes of interest that included change in peak oxygen consumption ( peak VO2 ) , hospitalizations , and mortality .


Exercise training was not associated with significant changes in levels of NT-proBNP ( P = .10 ) , hs-CRP ( P = .80 ) , or detectable cTnT levels ( P = .83 ) at 3 months .


Controlling for baseline biomarker levels or volume of exercise did not alter these findings .


Decreases in plasma concentrations of NT-proBNP , but not hs-CRP or cTnT , were associated with increases in peak VO2 ( P < .001 ) at 3 months and decreased risk of hospitalizations or mortality ( P .04 ) , even after adjustment for a comprehensive set of known predictors .


Exercise training did not lead to meaningful changes in biomarkers of myocardial stress , inflammation , or necrosis in patients with chronic HF .


Only improvements in NT-proBNP translated to reductions in peak VO2 and reduced risk of clinical events .


Biofortification is a strategy to relieve vitamin A ( VA ) deficiency .


Biofortified maize contains enhanced provitamin A concentrations and has been bioefficacious in animal and small human studies .


The study sought to determine changes in total body reserves ( TBRs ) of vitamin A with consumption of biofortified maize .


A randomized , placebo-controlled biofortified maize efficacy trial was conducted in 140 rural Zambian children .


The paired ( 13 ) C-retinol isotope dilution test , a sensitive biomarker for VA status , was used to measure TBRs before and after a 90-d intervention .


Treatments were white maize with placebo oil ( VA - ) , orange maize with placebo ( orange ) , and white maize with VA in oil [ 400 g retinol activity equivalents ( RAEs ) in 214 L daily ] ( VA + ) .


In total , 133 children completed the trial and were analyzed for TBRs ( n = 44 or 45/group ) .


Change in TBR residuals were not normally distributed ( P < 0.0001 ) ; median changes ( 95 % CI ) were as follows : VA - , 13 ( -19 , 44 ) mol ; orange , 84 ( 21 , 146 ) mol ; and VA + , 98 ( 24 , 171 ) mol .


Nonparametric analysis showed no statistical difference between VA + and orange ( P = 0.34 ) ; both were higher than VA - ( P = 0.0034 ) .


Median ( 95 % CI ) calculated liver reserves at baseline were 1.04 ( 0.97 , 1.12 ) mol/g liver , with 59 % > 1 mol/g , the subtoxicity cutoff ; none were < 0.1 mol/g , the deficiency cutoff .


The calculated bioconversion factor was 10.4 g - carotene equivalents/1 g retinol by using the middle 3 quintiles of change in TBRs from each group .


Serum retinol did not change in response to intervention ( P = 0.16 ) but was reduced with elevated C-reactive protein ( P = 0.0029 ) and -1 - acid glycoprotein ( P = 0.0023 ) at baseline .


- Carotene from maize was efficacious when consumed as a staple food in this population and could avoid the potential for hypervitaminosis A that was observed with the use of preformed VA from supplementation and fortification .


Use of more sensitive methods other than serum retinol alone , such as isotope dilution , is required to accurately assess VA status , evaluate interventions , and investigate the interaction of VA status and infection .


This trial was registered at clinicaltrials.gov as NCT01814891 .


Submassive pulmonary embolism ( PE ) has a low mortality rate but can degrade functional capacity .


The present study aims to provide rationale , methodology , and initial findings of a multicentre , randomised trial of fibrinolysis for PE that used a composite end-point , including quality of life measures .


This investigator-initiated study was funded by a contract between a corporate partner and the investigator 's hospital ( the prime site ) .


The investigator was the Food and Drug Administration ( FDA ) sponsor .


The prime site subcontracted , indemnified , and trained consortia members .


Consenting , normotensive patients with PE and right ventricular strain ( by echocardiography or biomarkers ) received low-molecular-weight heparin and random assignment to a single bolus of tenecteplase or placebo in double-blinded fashion .


The outcomes were : ( i ) in-hospital rate of intubation , vasopressor support , and major haemorrhage , or ( ii ) at 90 days , death , recurrent PE , or composite that defined poor quality of life ( echocardiography , 6 min walk test and surveys ) .


The planned sample size was n = 200 .


Eight sites enrolled 87 patients over 5 years .


The ratio of patients screened for each enrolled was 7.4 to 1 , equating to 11 h screening time per patient enrolled .


Primary barrier to enrolment was the cost of screening .


Two patients died ( 2.5 % , 95 % CI [ 0-8 % ] ) , one developed shock , but 18 ( 22 % , 95 % CI : [ 13-30 % ] ) had a poor quality of life .


An investigator-initiated , FDA-regulated , multicentre trial of fibrinolysis for submassive PE was conducted , but was limited by screening costs and a low mortality rate .


Quality of life measurements might represent a more important patient-centred end-point .


Crashes are the leading cause of death for teens , and parent-based interventions are a promising approach .


We assess the effectiveness of Steering Teens Safe , a parent-focused program to increase safe teen driving .


Steering Teens Safe aimed to improve parental communication with teens about safe driving using motivational interviewing techniques in conjunction with 19 safe driving lessons .