The primary outcome is the number of days with bothersome pain over 12 months .


Secondary measures are self-rated health ( EQ-5D ) , function ( the Roland Morris Disability Questionnaire ) , psychological profile ( the Multidimensional Pain Inventory ) , pain intensity ( the Numeric Rating Scale ) , and work absence.The primary utility measure of the study is quality-adjusted life years and will be calculated using the EQ-5D questionnaire .


Direct medical costs as well as indirect costs will be considered.Subjects are randomly allocated into two treatment arms : 1 ) Symptom-guided treatment ( patient controlled ) , receiving care when patients feel a need .


2 ) Preventive treatment ( clinician controlled ) , receiving care on a regular basis .


Eligibility screening takes place in two phases : first , when assessing the primary inclusion/exclusion criteria , and then to only include fast responders , i.e. , subjects who respond well to initial treatment .


Data are collected at baseline and at follow-up as well as weekly , using SMS text messages .


This study investigates a manual strategy ( chiropractic maintenance care ) for recurrent and persistent LBP and aims to answer questions regarding the effect and cost-effectiveness of this preventive approach .


Strict inclusion criteria should ensure a suitable target group and the use of frequent data collection should provide an accurate outcome measurement .


The study utilizes normal clinical procedures , which should aid the transferability of the results .


Clinical trials.gov ; NCT01539863 , February 22 , 2012 .


The first patient was randomized into the study on April 13th 2012 .


This multicentre , randomised , non-blinded , parallel group study is designed to assess the null hypothesis that a 3-month prophylactic schedule with fosfomycin is not inferior to prulifloxacin in reducing the number of urinary tract infection episodes during and after prophylaxis in female patients with recurrent urinary tract infections ( rUTIs ) .


One hundred and fifty-two patients with rUTIs who were candidates for prophylaxis therapy were enrolled and randomised to prulifloxacin ( group 1 ) or fosfomycin ( group 2 ) .


The prophylaxis regimen included a single dose of fosfomycin ( one 3-g cachet ) per week , or a single dose ( 600mg ) of prulifloxacin ( one tablet ) a week for 12 weeks .


The inclusion criteria were female patients over 18 years , urine culture responsiveness to drugs at patient recruitment and history of rUTI .


Exclusion criteria were pregnancy and counter-indications to this drug therapy .


Patients were prospectively randomised .


Check-ups were scheduled at 2 weeks , 1 month and 3 months from the beginning of the study and 3 , 6 , and 12 months after suspension of the therapy .


The primary end-points were the reduction of the number of UTIs ( negative urine culture ) during and after prophylaxis .


Final data analysis included 67 patients in group 1 and 57 in group 2 .


Nine out of 76 patients ( group 1 ) and 19 out of 76 ( group 2 ) dropped out .


UTI episodes were significantly reduced in number compared with before prophylaxis ( p < 0.0001 ) at all study end-points in both groups .


No significant differences were found in disease-free duration , as achieved by the two therapy groups ( log-rank test ; p = 0.41 ) , in the reduction of UTI episodes during and after prophylaxis , in the adverse effects or improved quality of life .


Both drugs provided adequate prophylaxis in patients with rUTIs , with no difference in efficacy .


Psychological interventions are used in patients with inflammatory bowel disease ( IBD ) but there is uncertainty about who the optimal target population is .


Multi-convergent therapy ( MCT ) is a form of psychotherapy that combines mindfulness meditation with aspects of cognitive behavioural therapy and has been used in the management of irritable bowel syndrome ( IBS ) .


This study aimed to assess the feasibility and efficacy of MCT in the management of IBD patients with either functional abdominal symptoms or high perceived stress levels .


Sixty-six IBD patients in clinical remission with either IBS-type symptoms or high perceived stress levels were randomly allocated to a 16-week MCT course or waiting list control group .


Patients were followed-up for one year with the Inflammatory Bowel Disease Questionnaire ( IBDQ ) as the primary outcome measurement .


A higher mean IBDQ score was observed in the active group compared to controls at the 4-month assessment ( 167 vs. 156 , p = 0.081 ) , but this was not statistically significant nor did it reached the predefined clinically significant difference of 20 .


In patients with IBS-type symptoms at baseline there was a significantly higher mean IBDQ score in the active group compared to controls ( 161 vs. 145 , p = 0.021 ) .


There was no difference between groups in relapse rate based on faecal calprotectin measurement .


IBS-type symptoms in patients with IBD represent a potential therapeutic target to improve quality of life .


This study suggests that MCT may be useful in the management of these symptoms but larger studies are required to confirm this .


NCT01426568 .


This study sought to report the treatment effect of ticagrelor on myocardial infarction ( MI ) and the strategy for and impact of event adjudication in the PLATO ( Platelet Inhibition and Patient Outcomes ) trial .


In PLATO , ticagrelor reduced cardiovascular death , MI , or stroke in patients with acute coronary syndromes ( ACS ) .


A clinical events committee ( CEC ) prospectively defined and adjudicated all suspected MI events , on the basis of events reported by investigators and by triggers on biomarkers .


Treatment comparisons used CEC-adjudicated data , and per protocol , excluded silent MI .


Overall , 1,299 ( 610 ticagrelor , 689 clopidogrel ) MIs reported by the CEC occurred during the trial .


Of these , 1,097 ( 504 ticagrelor , 593 clopidogrel ) contributed to the primary composite endpoint .


Site investigators reported 1,198 ( 580 ticagrelor , 618 clopidogrel ) MIs .


Ticagrelor significantly reduced overall MI rates ( 12-month CEC-adjudicated Kaplan-Meier rates : 5.8 % ticagrelor , 6.9 % clopidogrel ; hazard ratio [ HR ] : 0.84 ; 95 % confidence interval [ CI ] : 0.75 to 0.95 ) .


Nonprocedural MI ( HR : 0.86 ; 95 % CI : 0.74 to 1.01 ) and MI related to percutaneous coronary intervention or stent thrombosis tended to be lower with ticagrelor .


MIs related to coronary artery bypass graft surgery were few , but numerical excess was observed in patients assigned ticagrelor .


Analyses of overall MIs using investigator-reported data showed similar results but did not reach statistical significance ( HR : 0.88 ; 95 % CI : 0.78 to 1.00 ) .


In patients with ACS , ticagrelor significantly reduced the incidence of MI compared with clopidogrel , with consistent results across most MI subtypes .


CEC procedures identified more MI endpoints compared with site investigators .


( A Comparison of Ticagrelor [ AZD6140 ] and Clopidogrel in Patients With Acute Coronary Syndrome [ PLATO ] ; NCT00391872 ) .


Improving diet and lifestyle is important for prevention of cardiovascular disease ( CVD ) .


Observational evidence suggests that increasing fruit and vegetable ( FV ) consumption may lower CVD risk , largely through modulation of established risk factors , but intervention data are required to fully elucidate the mechanisms by which FVs exert benefits on vascular health .


The aim of this study was to examine the dose-response effect of FV intake on cardiovascular risk factors in adults at high CVD risk .


This was a randomized controlled parallel group study involving overweight adults ( BMI : > 27 and 35 kg/m ( 2 ) ) with a habitually low FV intake ( 160 g/d ) and a high total risk of developing CVD ( estimated 20 % over 10 y ) .


After a 4-wk run-in period where FV intake was limited to < 2 portions/d ( < 160 g/d ) , 92 eligible participants were randomly assigned to 1 of 3 groups : to consume either 2 , 4 , or 7 portions ( equivalent to 160 g , 320 g , or 560 g , respectively ) of FVs daily for 12 consecutive weeks .


Fasting venous blood samples were collected at baseline ( week 4 ) and post-intervention ( week 16 ) for analysis of lipid fractions and high-sensitivity C-reactive protein ( hsCRP ) concentrations .


Compliance with the FV intervention was determined with use of self-reported FV intake and biomarkers of micronutrient status .


Ambulatory blood pressure and body composition were also measured pre - and post-intervention .


A total of 89 participants completed the study and body composition remained stable throughout the intervention period .


Despite good compliance with the intervention , no significant difference was found between the FV groups for change in measures of ambulatory blood pressure , plasma lipids , or hsCRP concentrations .


There was no evidence of a dose-response effect of FV intake on conventional CVD risk factors measured in overweight adults at high CVD risk .


This trial was registered at clinicaltrials.gov as NCT00874341 .


To compare the effect of a balance and stability-focused outpatient community-based rehabilitation and a regular physiotherapy program on balance , stability , and perceptions of improvement after acute stroke .


A randomized controlled trial in a community-based therapy center .


Fifty consecutive patients with a first stroke , who reported to a community-based therapy center over a 7-month period were allocated to the control group ( regular physiotherapy ) or the experimental group ( balance and stability-focused rehabilitation ) .


A program of physiotherapy focused on balance and stability exercises .


The control group received the regular physiotherapy program .


The Postural Assessment Scale for Stroke Patients ( PASS ) and the Berg Balance Scale ( BBS ) monitored stability and balance .


The normalized data ( PASS and BBS ) were analyzed by using analysis of covariance .


Qualitative data were thematically described .


Internal consistency of baseline PASS and BBS scores was high ( Cronbach , .964 and .974 , respectively ) .


PASS overall pretest scores increased from 21.96 21.41 ( mean standard deviation ) and 21.52 8.43 to 67.67 28.42 and 80.16 22.60 posttest in the control and experimental groups , respectively .


Posttest scores were significantly different ( P = .004 ) .


The effect size was medium ( .490 ) .


The overall BBS scores showed overall mean ( standard deviation ) increases from 44.71 22.24 and 43.43 17.11 pretest to 48.71 23.18 and 59.71 18.20 posttest for the control and experimental groups , respectively .


The effect size was considered medium ( .532 ) .


The balance and stability-focused community-based rehabilitation program was more effective in improving stability and balance in patients with stroke compared with the regular physiotherapy program in resource-poor settings .


A phase 3 trial assessing response-based therapy in intermediate-risk Hodgkin lymphoma mandated real-time central review of involved field radiation therapy ( IFRT ) and imaging records by a centralized review center to maximize protocol compliance .


We report the impact of centralized radiation therapy review on protocol compliance .


Review of simulation films , port films , and dosimetry records was required before and after treatment .


Records were reviewed by study-affiliated or review center-affiliated radiation oncologists .


A deviation of 6 % to 10 % from protocol-specified dose was scored as `` minor '' ; a deviation of > 10 % was `` major . ''


A volume deviation was scored as `` minor '' if margins were less than specified or `` major '' if fields transected disease-bearing areas .


Interventional review and final compliance review scores were assigned to each radiation therapy case and compared .


Of 1712 patients enrolled , 1173 underwent IFRT at 256 institutions in 7 countries .


An interventional review was performed in 88 % of patients and a final review in 98 % .


Overall , minor and major deviations were found in 12 % and 6 % of patients , respectively .


Among the cases for which 1 pre-IFRT modification was requested by the Quality Assurance Review Center and subsequently made by the treating institution , 100 % were made compliant on final review .


By contrast , among the cases for which 1 modification was requested but not made by the treating institution , 10 % were deemed compliant on final review .


In a large trial with complex treatment pathways and heterogeneous radiation therapy fields , central review was performed in a large percentage of cases before IFRT and identified frequent potential deviations in a timely manner .


When suggested modifications were performed by the institutions , deviations were almost eliminated .


Prescription of inhaled corticosteroids to children with asthma is recommended at half the nominal dose of adults in order to reduce the risk of systemic side effects .


However , there is a lack of pharmacokinetic trials supporting such dose reduction regimens .


Therefore , we aimed to compare the systemic exposure to the active ingredients of a fixed dose combination of beclometasone-dipropionate ( BDP ) and formoterol after dry powder inhaler ( DPI ) administration in children , adolescents and adults .


The pharmacokinetic profiles of formoterol and beclometasone-17-monopropionate ( B17MP ; active metabolite of BDP ) were evaluated over 8 h from two independent studies comprising children ( 6-11yrs , n = 27 ) , adolescents ( 12-17 yrs , n = 28 ) and adults ( 18 yrs , n = 30 ) receiving a single , fixed dose of BDP/formoterol ( children : 200 g/24 g , adolescents and adults : 400 g/24 g ) via DPI .


The systemic exposure ( AUC ) for children versus adults was almost doubled for formoterol and similar for B17MP despite the halved BDP dose administered in children .


In adolescents the AUC for formoterol and B17MP were approximately one third higher than in adults for both compounds .


Upon normalization for the BDP/formoterol dose in the three populations the AUC and peak concentration ( C ( max ) ) correlated inversely with age and body surface area of the patients ( r -0.53 ; p < 0.0001 ) .


The systemic exposure to the active ingredients of BDP/formoterol administered as DPI correlates inversely with age and body size suggesting that dry powder dosage regimens should be adjusted for age and body size to avoid high systemic drug levels in children .


Pathogenic bacteria are often asymptomatically carried in the nasopharynx .


Bacterial carriage can be reduced by vaccination and has been used as an alternative endpoint to clinical disease in randomised controlled trials ( RCTs ) .


Vaccine efficacy ( VE ) is usually calculated as 1 minus a measure of effect .


Estimates of vaccine efficacy from cross-sectional carriage data collected in RCTs are usually based on prevalence odds ratios ( PORs ) and prevalence ratios ( PRs ) , but it is unclear when these should be measured .


We developed dynamic compartmental transmission models simulating RCTs of a vaccine against a carried pathogen to investigate how VE can best be estimated from cross-sectional carriage data , at which time carriage should optimally be assessed , and to which factors this timing is most sensitive .


In the models , vaccine could change carriage acquisition and clearance rates ( leaky vaccine ) ; values for these effects were explicitly defined ( f ( acq ) , 1/f ( dur ) ) .


POR and PR were calculated from model outputs .


Models differed in infection source : other participants or external sources unaffected by the trial .


Simulations using multiple vaccine doses were compared to empirical data .


The combined VE against acquisition and duration calculated using POR ( VE ( acq.dur ) , ( 1-POR ) 100 ) best estimates the true VE ( VE ( acq.dur ) , ( 1-f ( acq ) f ( dur ) ) 100 ) for leaky vaccines in most scenarios .


The mean duration of carriage was the most important factor determining the time until VE ( acq.dur ) first approximates VE ( acq.dur ) : if the mean duration of carriage is 1-1 .5 months , up to 4 months are needed ; if the mean duration is 2-3 months , up to 8 months are needed .


Minor differences were seen between models with different infection sources .


In RCTs with shorter intervals between vaccine doses it takes longer after the last dose until VE ( acq.dur ) approximates VE ( acq.dur ) .


The timing of sample collection should be considered when interpreting vaccine efficacy against bacterial carriage measured in RCTs .


Adoption of long-acting reversible contraception ( LARC ) ( ie , the intrauterine device or the contraceptive implant ) immediately after abortion is associated with high contraceptive satisfaction and reduced rates of repeat abortion .


Theory-based counseling interventions have been demonstrated to improve a variety of health behaviors ; data on theory-based counseling interventions for postabortion contraception are lacking .


Informed by the transtheoretical model of behavioral change , a video intervention was developed to increase awareness of , and dispel misconceptions about , LARC methods .


The intervention was evaluated in a randomized controlled trial among women aged 18-29 years undergoing surgical abortion at a clinic in Chicago , IL .


Participants were randomized 1:1 to watch the intervention video or to watch a stress management video ( control ) , both 7 minutes in duration .


Contraceptive methods were supplied to all participants free of charge .


Rates of LARC initiation immediately after abortion were compared .


Rates of LARC initiation immediately after abortion were not significantly different between the 2 study arms ; 59.6 % in the intervention and 51.6 % in the control arm chose a LARC method ( P = .27 ) .


This study resulted in an unexpectedly high rate of LARC initiation immediately after abortion .


High rates of LARC initiation could not be attributed to a theory-based counseling intervention .


Early neurocognitive changes in emotional processing are seen following SSRI administration , which may be involved in mechanisms of action .


However , the perceptual processes underpinning these effects have not been specified .


In a double-blind , placebo-controlled eye-tracking study , we assessed the effect of single dose of citalopram ( 20mg ) in 25 healthy females .


Face stimuli with direct and averted gaze were presented while visual scan patterns and pupil sizes were monitored .


Subjective state was monitored using visual analogue scales .


There were no significant effects of citalopram on subjective state .


However , the citalopram group displayed increased saccade numbers and shorter fixation duration during face viewing compared to the placebo group .


Volunteers receiving citalopram also showed reduced monitoring of the eye region irrespective of the direct or averted eye position of the stimuli .


The citalopram group also showed significantly larger pupil sizes than the control group .


These results suggest that the SSRI administration affects the perceptual processing of face stimuli .


The current pattern of findings is consistent with anxiogenic-like mechanisms early on in SSRI treatment .


Eye-tracking provides a novel method to characterise and detect these effects .


The need for new effective Helicobacter pylori eradication therapy has focused efforts on the development and optimization of regimens with excellent eradication rates such as 14-day hybrid therapy .


This study evaluated whether the duration of hybrid therapy could be reduced while maintaining a high eradication rate and to examine the effect of antibiotic resistance on outcome .


Three separate multicenter pilot studies were carried out concurrently .


To reduce selection bias , eligible subjects were randomized to 10-day , 12-day , or 14-day hybrid therapy consisting of esomeprazole 40 mg and amoxicillin 1 gm twice daily for 10 , 12 , or 14 days plus clarithromycin 500 mg , and metronidazole 500 mg twice daily for the final 7 days .


The primary outcome was H.pylori eradication per-protocol assessed at least 8weeks after therapy .


A total of 220 subjects were entered .


The per-protocol analyses contained 60 , 61 , 61 subjects in the 10 - , 12 - and 14-day therapy studies , respectively .


The eradication rates , per-protocol , were similar : 95 % ( 95 % confidence interval ( CI ) ; 89.5-100 % ) for 10-day , 95.1 % ( 95 % CI ; 89.7-100 % ) for 12-day , and 93.4 % ( 95 % CI ; 87.2-99 .7 % ) for 14-day hybrid therapies .


Antibiotic resistance was infrequent ; however , all metronidazole or clarithromycin resistances were cured with 12 - and 14-day therapies .


These results suggest that in regions of moderate to low clarithromycin and/or metronidazole resistance it may be feasible to shorten hybrid therapy to 10 or 12days .


Further study is needed to compare hybrid and concomitant therapy in regions with moderate-to-high clarithromycin and/or metronidazole resistance .


It is not clear whether subgroups of patients with peripheral artery disease ( PAD ) and claudication respond more favorably to exercise rehabilitation than others .


We determined whether sex and diabetes were factors associated with the response to exercise rehabilitation in patients with claudication .


Eighty patients were randomized to home-based and supervised exercise programs , and 60 finished with complete exercise intervention data .


Exercise consisted of intermittent walking to near maximal claudication pain for 3 months .


Primary outcome measures included claudication onset time ( COT ) and peak walking time .


Patients were partitioned into diabetic and nondiabetic groups and then further partitioned by sex to form four groups .


Overall , exercise adherence was high ( 84 % ) , and there was no significant difference ( P > .05 ) in the amount of exercise completed among the four groups .


All groups had significant improvements ( P < .05 ) in COT and peak walking time after exercise rehabilitation , except for diabetic women ( P > .05 ) .


Only 37 % of women with diabetes had an increase in COT compared with 100 % of men with diabetes ( P < .01 ) , and their risk ratio for nonresponse was 9.2 ( P < .0001 ) .


Women with PAD and claudication , particularly those with diabetes , represent a vulnerable subgroup of patients who respond poorly to a program of exercise rehabilitation .


Diabetic women with PAD and claudication may need a greater dose of exercise or another intervention separate from or in combination with exercise to elicit improvements in claudication measures that are similar to nondiabetic women and to diabetic and nondiabetic men .


To determine the effects of intratesticular and incisional injection of local anesthetics on response to castration , surgical ease , and recovery in alpacas .


Prospective , blinded , randomized , and clinical trial .


Intact male alpacas ( n = 38 ) .


Alpacas were anesthetized with intramuscular butorphanol , ketamine , and xylazine ( BKX ) .


Once recumbent , alpacas were instrumented with electrocardiogram , pulse oximeter , oscillometric blood pressure , and capnography .


Heart rate ( HR ) , respiratory rate ( RR ) , and blood pressure ( BP ) were recorded every minute .


Treatment drug ( lidocaine , bupivacaine , or saline ) was infiltrated along the incision and into both testicles followed by a prescrotal closed castration .


Timing of major events , presence of movement during the procedure , need for additional anesthesia , and ease of surgery were recorded .


Alpacas were administered postoperative oral meloxicam and assessment was made 24hours after recovery .


Median RR and mean BP ( MBP ) were lower in the lidocaine compared with the saline treated group .


Median RR , HR , and MBP were significantly lower in the bupivacaine group compared with the saline group .


Fewer alpacas displayed physical response to surgical stimulus with bupivacaine .


No significant differences were found between groups for timing of events , need for additional anesthesia , ease of surgery , or postoperative assessment .


Intratesticular local anesthetic blunts autonomic response and facilitates castration in alpacas anesthetized with BKX with minimal negative effects .


Bupivacaine may have some benefit for local anesthesia during castration compared with lidocaine .


Alcohol-related violence in and in the vicinity of licensed premises continues to place a considerable burden on the United Kingdom 's ( UK ) health services .


Robust interventions targeted at licensed premises are therefore required to reduce the costs of alcohol-related harm .


Previous evaluations of interventions in licensed premises have a number of methodological limitations and none have been conducted in the UK .


The aim of the trial was to determine the effectiveness of the Safety Management in Licensed Environments intervention designed to reduce alcohol-related violence in licensed premises , delivered by Environmental Health Officers , under their statutory authority to intervene in cases of violence in the workplace .


A national randomised controlled trial , with licensed premises as the unit of allocation .


Premises were identified from all 22 Local Authorities in Wales .


Eligible premises were those with identifiable violent incidents on premises , using police recorded violence data .


Premises were allocated to intervention or control by optimally balancing by Environmental Health Officer capacity in each Local Authority , number of violent incidents in the 12months leading up to the start of the project and opening hours .


The primary outcome measure is the difference in frequency of violence between intervention and control premises over a 12month follow-up period , based on a recurrent event model .


The trial incorporates an embedded process evaluation to assess intervention implementation , fidelity , reach and reception , and to interpret outcome effects , as well as investigate its economic impact .


The results of the trial will be applicable to all statutory authorities directly involved with managing violence in the night time economy and will provide the first formal test of Health and Safety policy in this environment .


If successful , opportunities for replication and generalisation will be considered .


UKCRN 14077 ; ISRCTN78924818 .


A high prevalence of iron deficiency anemia persists in Bedouin Arab and Jewish pediatric populations in southern Israel .


To compare the effect of daily use of the micronutrient supplementation ( MMS ) , `` Sprinkles , '' a powdered formulation of iron , vitamins A and C , folic acid and zinc , with liquid iron and vitamins A and D on iron deficiency at 12 months of age .


The 621 eligible Bedouin and Jewish infants in the study were assigned to the MMS and control arms and received supplementations from age 6 to 12 months .


We examined the change in hemoglobin , hematocrit , mean cell volume , red blood cell distribution , serum ferritin and transferrin saturation .


In addition , we used the high Iron Deficiency Index ( IDI ) if two or more of the above six parameters showed abnormal levels .


Rates of anemia decreased significantly over the 6 month period , from 58.8 % to 40.6 % among Bedouin infants ( P = 0.037 ) and from 40.6 to 15.8 % among Jewish infants ( P = 0.017 ) .


In Bedouin infants the prevalence of high IDI decreased significantly from 79.2 % to 67.4 % ( P = 0.010 ) in the MMS group , but there was no change in the controls .


Among Jewish infants , the high IDI prevalence decreased from 67 % to 55.6 % with no statistically significant difference in the two study arms .


In the multivariate analysis in Bedouin infants MMS use was associated with a reduced risk of 67 % in high IDI at age 12 months as compared to controls ( P = 0.001 ) .


Fewer side effects in the intervention groups in both ethnic populations were reported .


MMS fortification of home food can be recommended as an effective and safe method for preventing iron deficiency anemia at 12 months of age .


To study the effect of a dietary supplement ( TARGET 1 : a combination of casozepine , taurine , Eleutherococcus senticosus and extramel ) on burnout symptomatology .


A 12-week , double-blind , randomized , placebo-controlled trial was conducted in workers engaged in professional contact with patients , students or clients .


All were affected by burnout syndrome based on a score of 4 on the Burnout Measure Scale ( BMS-10 ) .


The primary outcome measure was the change in the BMS-10 score ; secondary outcome measures included the change in the Maslach 's Burnout Inventory scale-Human Service Survey ( MBI-HSS ) score and the Beck Depression Inventory .


Five scores were evaluated .


Eighty-seven participants were enrolled in the study : 44 received the active formulation ( verum group ) ; 43 received placebo .


After 12 weeks ' supplementation , the placebo group showed significant improvements in scores for BMS-10 , MBI-HSS fatigue and the Beck Depression Inventory , but MBI-HSS depersonalization and task management were not improved ; the verum group showed significant improvements in all five scores .


The verum group consistently showed significantly greater improvements in scores than the placebo group .


TARGET 1 significantly improved the symptoms of burnout after 12 weeks ' use .


Among the available nucleos ( t ) ide analogues adefovir dipivoxil ( ADV ) is relatively cheap and widely used in rural area in China .


However , there are insufficient data on recommendation for patients with suboptimal response to ADV after 48 weeks of treatment in order to reduce the resistance rate in the long term .


The aim of this study was to compare the efficacy and safety of LAM add-on combination therapy versus ETV monotherapy for patients with suboptimal response to ADV.


136 patients with suboptimal response to ADV were randomly assigned to the add-on LAM with ADV combination therapy ( 68 patients ) group and the ETV monotherapy ( 68 patients ) group .


Patients in the add-on group were prescribed 100 mg LAM and 10 mg ADV per day , while the monotherapy group received 0.5 mg ETV per day for 48 weeks .


Tests for liver and kidney function , HBV serum markers , HBV DNA load , were performed every 3 months .


The mean patient age in LAM add-on group and ETV monotherapy was 38.59 7.65 and 37.56 8.67 years respectively .


The HBV DNA undetectable rate in the LAM add-on group and the ETV group were not significant difference at week 4 , 12 and 24 ( P > 0.05 ) .


However , the HBV undetectable rate in the ETV group was higher than that in the LAM add-on group at week 36 and 48 ( P = 0.043 for week 36 and P = 0.038 for week 48 ) .


There was no significant difference both for HBeAg loss and HBeAg seroconversion between two groups ( P > 0.05 ) at 48 weeks .


Meanwhile , our study also demonstrated that the mean eGFR levels in LAM add-on group was decreased from 99.6 8.71 at baseline to 86.4 9.83 at the end of 48 weeks , which was significantly higher than that in the ETV monotherapy group ( P < 0.05 ) .


8.8 % of patients in LAM add-on group experienced eGFR reduction by 20-30 % from baseline at 48 weeks .


No patients developed hyposphosphatemia in our study .


Our study clearly showed that switch to ETV monotherapy was the more effective and more safe than that of LAM add-on combination therapy for patients with suboptimal response to ADV.


A good patch test system should have good adhesion and contact , and minimal leakage ; Finn and IQ patch test system have these properties but are expensive .


To develop a new cost-effective occlusive patch test system that had good contact with the skin and was non-irritant .


The system ( designated Chamber X ) was fabricated using a semi-permeable tape and a flexible virgin plastic chamber .


Chamber X was developed by ( i ) selecting adhesive tape based on its non irritancy and adhesive potential ( ii ) testing plastic chamber material for its skin irritancy ( iii ) testing the assembled system against Finn , IQ and locally available chambers for irritancy , contact , leakage and occlusivity .


Chamber X showed better occlusion than IQ , Finn and locally available chambers and was comparable to , ( P > 0.05 ) IQ and Finn in terms of irritancy , contact and leakage .


The results demonstrate that the Chamber X offers a cost effective patch test system comparable to IQ and Finn chambers in terms of safety , adhesion , leakage and occlusivity .


To explore the effect of acupuncture-anesthetic composite anesthesia ( AACA ) on the incidence of postoperative cognitive dysfunction ( POCD ) and changes of TNF-alpha , IL-1beta , and IL-6 in elderly patients .


Totally 83 patients undergoing surgical resection of gastrointestinal tumor were randomly assigned to the simple anesthesia group ( A group , 41 cases ) and the AACA group ( B group , 42 cases ) .


Patients in Group A received endotracheal general anesthesia .


Those in Group B were induced by acupuncture anesthesia for 30 min by needling at Baihui ( DU20 ) , Neiguan ( PC6 ) , Zusanli ( ST36 ) .


The electro-acupuncture ( EA ) apparatus was connected after arrival of qi , with the wave pattern of density 2/100 Hz .


The stimulus intensity was set by patients ' tolerance , with the peak current of 5 mA .


Then the endotracheal general anesthesia was performed and the EA lasted till the end of the surgery .


The cognitive function of all patients was assessed before operation and at day 3 after operation using mini-mental state examination ( MMSE ) .


POCD was confirmed if with one or more decreased stand - ard .


The peripheral venous blood was collected before anesthesia induction ( TO ) , immediately at the end of surgery ( T1 ) , 24 h after operation ( T2 ) , and 48 h after operation ( T3 ) , and serum concentrations of IL-1beta , IL-6 , and TNF-alpha were correspondingly measured using ELISA .


The postoperative anesthesia awakening time was shorter in Group B than in Group A [ ( 20.37 + / - 6.09 ) min vs ( 29.24 + / - 7.48 ) min , P < 0.05 ] .


The remifentanil dose used during the operation was less in Group B than in Group A ( P < 0.05 ) .


The incidence of POCD at day 3 was lower in Group B than in Group A [ 10/41 ( 23.8 % ) vs 15/42 ( 36.5 % ) , P < 0.05 ] .


The concentrations of IL-1beta , IL-6 , and TNF-alpha at T1-T3 were higher than those at TO in the two groups ( P < 0.05 ) .


The increment of TNF-alpha and IL-1beta was less in Group B than in Group A ( P < 0.05 ) .


CONCLUSION AACA could reduce the incidence of POCD and inhibit postoperative release of TNF-alpha , IL-1beta , and IL-6 in elderly patients undergoing colorectal cancer resection .


To determine if a video depicting cardiopulmonary resuscitation and resuscitation preference options would improve knowledge and decision making among patients and surrogates in the ICU .


Randomized , unblinded trial .


Single medical ICU .


Patients and surrogate decision makers in the ICU .


The usual care group received a standard pamphlet about cardiopulmonary resuscitation and cardiopulmonary resuscitation preference options plus routine code status discussions with clinicians .


The video group received usual care plus an 8-minute video that depicted cardiopulmonary resuscitation , showed a simulated hospital code , and explained resuscitation preference options .


One hundred three patients and surrogates were randomized to usual care .


One hundred five patients and surrogates were randomized to video plus usual care .


Median total knowledge scores ( 0-15 points possible for correct answers ) in the video group were 13 compared with 10 in the usual care group , p value of less than 0.0001 .


Video group participants had higher rates of understanding the purpose of cardiopulmonary resuscitation and resuscitation options and terminology and could correctly name components of cardiopulmonary resuscitation .


No statistically significant differences in documented resuscitation preferences following the interventions were found between the two groups , although the trial was underpowered to detect such differences .


A majority of participants felt that the video was helpful in cardiopulmonary resuscitation decision making ( 98 % ) and would recommend the video to others ( 99 % ) .


A video depicting cardiopulmonary resuscitation and explaining resuscitation preference options was associated with improved knowledge of in-hospital cardiopulmonary resuscitation options and cardiopulmonary resuscitation terminology among patients and surrogate decision makers in the ICU , compared with receiving a pamphlet on cardiopulmonary resuscitation .


Patients and surrogates found the video helpful in decision making and would recommend the video to others .


This study examines the efficacy of the buprenorphine transdermal system ( BTDS ) for reducing the interference of pain on physical and emotional functioning associated with chronic low back pain ( CLBP ) .


A post-hoc analysis used data from a randomized , placebo-controlled , double-blind trial of patients with moderate-to-severe CLBP .


The Brief Pain Inventory ( BPI ) measured pain interference at screening , following a run-in period , and during the 12-week double-blind treatment phase .


Statistical analyses examined treatment arm differences ( BTDS vs placebo ) for the following : BPI Interference subscale items and subscale scores at the trial end point ( week 12 ) ; patterns of change in the Interference subscale scores over time ; proportions of patients indicating mild or no interference following treatment ; and proportions of patients showing improvement ( 30 % , 50 % , 2-point , or 4-point change in score from screening to week 12 ) for each item and subscale .


Mean scores for BPI Interference items and Interference subscale were significantly lower ( ie , indicated less interference ) for BTDS than for placebo ( all P < 0.001 ) .


Treatment arm differences in Interference subscale scores emerged within 4 weeks of treatment .


The BTDS patients were significantly more likely to indicate mild/no interference on 5 of 7 Interference subscale items following treatment ( P < 0.05 ) .


For most comparisons , BTDS patients were significantly more likely to show criterion-level improvements in Interference item and subscale scores ( P < 0.05 for differences ) .


Results indicate the efficacy of BTDS treatment , compared with placebo , for reducing the interference of pain on physical and emotional functioning in patients with moderate-to-severe CLBP .


The advantage of BTDS was observed within 4 weeks of treatment , and was maintained throughout the 12-week treatment phase .


Although the effects of caffeine on basic cognitive functions are well-known , its effects on more complex decision making , particularly on option generation , is yet to be explored .


We examined the effects of caffeine on option generation in decision making using everyday life decisional situations .


In a double-blind placebo-controlled experiment , participants ( N = 47 ) either received 300 mg of caffeine or a placebo .


Participants had to generate choice options ( things they could do ) for a series of high and low familiar real-world scenarios and , subsequently , to decide among these options .


Analyses revealed that participants in the caffeine condition generated significantly fewer options than participants in the placebo condition .


Moreover , caffeine significantly reduced the option generation onset time , that is , participants in the caffeine condition generated their first option significantly faster than participants in the placebo condition .


Regarding subsequent choice , we found evidence supporting the `` take-the-first '' heuristic , that is , the tendency to select the first generated option .


This tendency was neither affected by caffeine nor by the familiarity of the scenarios .


Caffeine results in fewer options generated in unconstrained real-life decision-making situations and decreases generation onset times .


Previous studies demonstrated that the anti-CD3 monoclonal antibody otelixizumab , administered at a total dose of 48-64 mg , can slow the loss of C-peptide in recent-onset type 1 diabetes patients , with frequent reactivation of Epstein Barr virus ( EBV ) .


The DEFEND-1 ( Durable Response Therapy Evaluation for Early or New-Onset Type 1 Diabetes ) trial was designed to test whether a lower dose of otelixizumab could preserve C-peptide secretion in new-onset type 1 diabetes patients .


A multicenter , randomized , placebo-controlled trial was performed in sites in the U.S. , Canada , and Europe .


Two hundred eighty-one patients were randomized to treatment with 3.1 mg otelixizumab administered over 8 days or placebo .


The primary end point of the study was the change in C-peptide area under the curve ( AUC ) from a 2-h mixed-meal tolerance test at month 12 .


The change in 2-h C-peptide AUC was not different between placebo-treated patients and otelixizumab-treated patients ( -0.20 vs. -0.22 nmol/L , P = 0.81 ) .


Secondary end points , including HbA1c , glucose variability , and insulin dose , were also not statistically different between the two groups .


More patients in the otelixizumab group than in the placebo group experienced adverse events , mostly grade 1 or grade 2 .


There was no EBV reactivation ( viral load > 10,000 copies/10 ( 6 ) peripheral blood mononuclear cells ) in the otelixizumab group , in contrast with previously published studies at higher doses of otelixizumab .


Otelixizumab was well tolerated in patients with recent-onset type 1 diabetes at a total dose of 3.1 mg , but did not achieve preservation of levels of C-peptide or other markers of metabolic control .


It is well established that insecticide-treated bed nets ( ITNs ) , in particular long-lasting , insecticidal nets ( LLINs ) , can be used as one of the primary interventions for effective malaria control .


A consistent gap between net ownership and use has been observed , indicating that factors exist that prevent an owned mosquito net from being used .


One approach used in the context of LLIN campaigns is a post-distribution , door-to-door visit of households with educational messages and to physically assist with hang-up of nets .


A cluster randomized trial was conducted in the Plateaux Region of Togo to evaluate the effectiveness of different approaches to post-LLIN campaign home visits ( number of visits and timing ) by volunteers to enhance LLIN hang-up and utilization .


It was found that , in general , households that received intervention visits , particularly the most recent intervention visit , had levels of use that were typically 5 to 10 % higher than the control households , while access did not differ among control and intervention households .


Eight months post-campaign , ITN use by all individuals , children under five years and women of reproductive age was 11.3 to 14.4 percentage points greater in the study arm that received all three intervention visits than in the control communities .


In households that received one or two additional door-to-door visits , the majority of respondents indicated that the volunteer provided new information during the visit regarding the use and importance of ITNs despite having received previous multiple visits .


The impact of the interventions appears to have been primarily through the delivery and reinforcement of key behaviour-change communication ( BCC ) messages regarding the importance of using an ITN and its care .


Regardless of whether the respondents in fact received new information or had forgotten earlier information , this suggests that regular visits from community agents are useful in reinforcing key BCC messages .


To increase childhood influenza vaccination rates using a toolkit and early vaccine delivery in a randomized cluster trial .


Twenty primary care practices treating children ( range for n = 536-8183 ) were randomly assigned to Intervention and Control arms to test the effectiveness of an evidence-based practice improvement toolkit ( 4 Pillars Toolkit ) and early vaccine supplies for use among disadvantaged children on influenza vaccination rates among children 6 months-18 years .


Follow-up staff meetings and surveys were used to assess use and acceptability of the intervention strategies in the Intervention arm .


Rates for the 2010-2011 and 2011-2012 influenza seasons were compared .


Two-level generalized linear mixed modeling was used to evaluate outcomes .


Overall increases in influenza vaccination rates were significantly greater in the Intervention arm ( 7.9 percentage points ) compared with the Control arm ( 4.4 percentage points ; P < 0.034 ) .


These rate changes represent 4522 additional doses in the Intervention arm vs. 1390 additional doses in the Control arm .


This effect of the intervention was observed despite the fact that rates increased significantly in both arms - 8/10 Intervention ( all P < 0.001 ) and 7/10 Control sites ( P-values = 0.04 to < 0.001 ) .


Rates in two Intervention sites with pre-intervention vaccination rates > 58 % did not significantly increase .


In regression analyses , a child 's likelihood of being vaccinated was significantly higher with : younger age , white race ( Odds ratio [ OR ] = 1.29 ; 95 % confidence interval [ CI ] = 1.23-1 .34 ) , having commercial insurance ( OR = 1.30 ; 95 % CI = 1.25-1 .35 ) , higher pre-intervention practice vaccination rate ( OR = 1.25 ; 95 % CI = 1.16-1 .34 ) , and being in the Intervention arm ( OR = 1.23 ; 95 % CI = 1.01-1 .50 ) .


Early delivery of influenza vaccine was rated by Intervention practices as an effective strategy for raising rates .


Implementation of a multi-strategy toolkit and early vaccine supplies can significantly improve influenza vaccination rates among children in primary care practices but the effect may be less pronounced in practices with moderate to high existing vaccination rates .


Clinical trial registry name/number : From Innovation to Solutions : Childhood Influenza/NCT01664793 .


To determine the effectiveness of an early physiotherapy intervention for the prevention of secondary lymphoedema on health-related quality of life in women who also received an education program after breast cancer surgery .


One hundred and fifty three women diagnosed with unilateral breast cancer ( stage I-II ) treated with breast surgery , which included axillary lymph-node dissection , from Hospital Prncipe de Asturias , Alcal de Henares , Madrid ( Spain ) were randomly assigned into two groups .


Subjects in early physiotherapy group ( n = 76 ) received a physiotherapy intervention combined with a therapeutic education program ; women in the control group ( n = 77 ) received only the therapeutic education program .


Both interventions were delivered by two different physiotherapists of Physiotherapy in Women 's Health Research Group at Physiotherapy Department of Alcala University .


Health related quality of life was measured with EORTC QLQ-C30 and EORTC QLQ-BR23 questionnaires in 5 assessments : after surgery just before group interventions started ( A1 ) , after the 3-week group interventions finished ( A2 ) ; and a follow-up period in 3 ( A3 ) , 6 ( A4 ) and 12 ( A5 ) months after surgical intervention .


Greater change in quality of life was observed for early physiotherapy group arm compared to control group , although no strong statistical evidence was found ( p > .05 ) for most of the dimensions except for physical function and social function areas ( p < .003 ) .


The control group with therapeutic education program reported a clear improvement in the perception of quality of life .


Adding early physiotherapy to the therapeutic education program did not show statistically significant changes in the global score or in most of the dimensions , but showed an improvement in the physical and social dimensions .


Myofascial pain syndrome ( MPS ) in the shoulder is among the most prevalent pain problems in the middle-aged population worldwide .


Evidence suggests that peripheral and central sensitization may play an important role in the development and maintenance of shoulder MPS .


Given previous research supporting the potential efficacy of anodal transcranial direct current stimulation ( tDCS ) for modulating pain-related brain activity in individuals with refractory central pain , we hypothesized that anodal tDCS when applied over the primary motor cortex ( M1 ) combined with standard treatment will be more effective for reducing pain in patients with MPS than standard treatment alone .


Study participants were randomized to receive either ( 1 ) standard treatment with 5 consecutive days of 1 mA anodal tDCS over M1 for 20 minutes ; or ( 2 ) standard treatment plus sham tDCS .


Measures of pain intensity , shoulder passive range of motion ( PROM ) , analgesic medication use , and self-reported physical functioning were administered before treatment and again at posttreatment and 1 - , 2 - , 3 - , and 4-week follow-up .


Thirty-one patients with MPS were enrolled .


Participants assigned to the active tDCS condition reported significantly more pretreatment to posttreatment reductions in pain intensity that were maintained at 1-week posttreatment , and significant improvement in shoulder adduction PROM at 1-week follow-up than participants assigned to the sham tDCS condition .


Five consecutive days of anodal tDCS over M1 combined with standard treatment appears to reduce pain intensity and may improve PROM , faster than standard treatment alone .


Further tests on the efficacy and duration of effects of tDCS in the treatment of MPS are warranted .


There are a wide variety of non - pharmacologic pain relief techniques for labor which include pelvic movement , upright position , back massage and partner support during the first stage of labor .


The effectiveness of dance labor - which is a combination of these techniques - has not been evaluated .


This study aimed to evaluate the effectiveness of dance labor in pain reduction and woman 's satisfaction during the first stage of labor .


60 primiparous women aged 18-35 years old were randomly assigned to dance labor and control groups .


In the dance labor group , women were instructed to do standing upright with pelvic tilt and rock their hips back and forth or around in a circle while their partner massaged their back and sacrum for a minimum of 30 minutes .


In the control group , the participants received usual care during physiologic labor .


Pain and satisfaction scores were measured by Visual Analogue Scale .


Data were analyzed by using the t. test and Chi-square .


Mean pain score in the dance labor group was significantly lower than the control group ( P < 0.05 ) .


The mean satisfaction score in the dance labor group was significantly higher than in the control group ( P < 0.05 ) .


Dance labor which is a complementary treatment with low risk can reduce the intensity of pain and increase mothers , satisfaction with care during the active phase of labor .


The study sought to evaluate the relationship between procedural volume and outcomes with radial and femoral approach .


RIVAL ( RadIal Vs. femorAL ) was a randomized trial of radial versus femoral access for coronary angiography/intervention ( N = 7,021 ) , which overall did not show a difference in primary outcome of death , myocardial infarction , stroke , or non-coronary artery bypass graft major bleeding .


In pre-specified subgroup analyses , the hazard ratios for the primary outcome were compared among centers divided by tertiles and among individual operators .


A multivariable Cox proportional hazards model was used to determine the independent effect of center and operator volumes after adjusting for other variables .


In high-volume radial centers , the primary outcome was reduced with radial versus femoral access ( hazard ratio [ HR ] : 0.49 ; 95 % confidence interval [ CI ] : 0.28 to 0.87 ) but not in intermediate - ( HR : 1.23 ; 95 % CI : 0.88 to 1.72 ) or low-volume centers ( HR : 0.83 ; 95 % CI : 0.52 to 1.31 ; interaction p = 0.021 ) .


High-volume centers enrolled a higher proportion of ST-segment elevation myocardial infarction ( STEMI ) .


After adjustment for STEMI , the benefit of radial access persisted at high-volume radial centers .


There was no difference in the primary outcome between radial and femoral access by operator volume : high-volume operators ( HR : 0.79 ; 95 % CI : 0.48 to 1.28 ) , intermediate ( HR : 0.87 ; 95 % CI : 0.60 to 1.27 ) , and low ( HR : 1.10 ; 95 % CI : 0.74 to 1.65 ; interaction p = 0.536 ) .


However , in a multivariable model , overall center volume and radial center volume were independently associated with the primary outcome but not femoral center volume ( overall percutaneous coronary intervention volume HR : 0.92 , 95 % CI : 0.88 to 0.96 ; radial volume HR : 0.88 , 95 % CI : 0.80 to 0.97 ; and femoral volume HR : 1.00 , 95 % CI : 0.94 to 1.07 ; p = 0.98 ) .


Procedural volume and expertise are important , particularly for radial percutaneous coronary intervention .


( A Trial of Trans-radial Versus Trans-femoral Percutaneous Coronary Intervention [ PCI ] Access Site Approach in Patients With Unstable Angina or Myocardial Infarction Managed With an Invasive Strategy [ RIVAL ] ; NCT01014273 ) .


The purpose of this study was to assess the effect of guanfacine extended release ( GXR ) adjunctive to a psychostimulant on oppositional symptoms in children and adolescents with attention-deficit/hyperactivity disorder ( ADHD ) .


A multicenter , double-blind , placebo-controlled dose-optimization study of GXR ( 1-4mg / d ) or placebo administered morning ( a.m. ) or evening ( p.m. ) adjunctive to psychostimulant was conducted in subjects ages 6-17 with suboptimal response to psychostimulant alone .


Suboptimal response was defined as treatment with a stable dose of psychostimulant for 4 weeks with ADHD Rating Scale IV total score 24 and Clinical Global Impressions-Severity of Illness score 3 , as well as investigator opinion .


Primary efficacy and safety results have been reported previously .


Secondary efficacy measures included the oppositional subscale of the Conners ' Parent Rating Scale-Revised : Long Form ( CPRS-R : L ) ; these are reported herein .


Significant reductions from baseline to the final on-treatment assessment on the oppositional subscale of the CPRS-R : L were seen with GXR plus psychostimulant compared with placebo plus psychostimulant , both in the overall study population ( placebo-adjusted least squares [ LS ] mean change from baseline to the final on-treatment assessment : GXR a.m. + psychostimulant , -2.4 , p = 0.001 ; GXR p.m. + psychostimulant , -2.2 , p = 0.003 ) as well as in the subgroup of subjects with significant baseline oppositional symptoms ( GXR a.m. + psychostimulant , -3.6 , p = 0.001 ; GXR p.m. + psychostimulant , -2.7 , p = 0.013 ) .


Treatment-emergent adverse events were reported by 77.3 % , 76.3 % , and 63.4 % of subjects in the GXR a.m. , GXR p.m. , and placebo groups , respectively , in the overall study population .


GXR adjunctive to a psychostimulant significantly reduced oppositional symptoms compared with placebo plus a psychostimulant in subjects with ADHD and a suboptimal response to psychostimulant alone .


This paper describes the effectiveness of cognitive stimulation therapy ( CST ) on cognition and depressive symptoms in older adults in nursing homes ( NHs ) .


A randomized controlled trial , carried out from 2012 to 2013 , included 56 residents from four NHs , 36 women and 20 men ( randomized into experimental and control groups ) .


Eight participants dropped out .


Participants of the experimental group underwent 14 CST sessions ( 7 weeks ) in groups of six to eight older adults , and participants of the control group received usual care .


The Montreal Cognitive Assessment , the Geriatric Depression Scale-15 , and the Barthel Index of activities of daily living ( ADLs ) were administered at baseline and postintervention .


Repeated measures revealed that CST increased cognition ( F = 8.581 ; p = .005 ; partial squared = 0.157 ; power = 0.82 ) .


There were no statistically significant differences in depressive symptoms ( F = 1.090 ; p = .302 ) .


Baseline level of ADLs did not affect the outcomes .


CST had significantly improved cognition , explaining the 15.7 % variability , but there was no statistical evidence of its effectiveness on depressive symptoms .


This improvement was not affected by the baseline level of dependence-independence in ADLs .


CST offers a range of activities , providing general stimulation for thinking , concentration , and memory , usually in a social setting .


These results will support implementation of CST in NHs .


In addition to the impact on elderly independence and autonomy , CST may also have an economic impact by reducing the direct costs of the impact of elders ' cognitive frailty .


This study examines the role of ( 18 ) F-labeled fluorodeoxyglucose positron emission tomography ( FDG-PET ) in the implementation of involved-node radiation therapy ( INRT ) in patients treated for clinical stages ( CS ) I/II supradiaphragmatic Hodgkin lymphoma ( HL ) .


Patients with untreated CS I/II HL enrolled in the randomized EORTC/LYSA/FIL Intergroup H10 trial and participating in a real-time prospective quality assurance program were prospectively included in this study .


Data were electronically obtained from 18 French cancer centers .


All patients underwent APET-computed tomography ( PET-CT ) and a post-chemotherapy planning CT scanning .


The pre-chemotherapy gross tumor volume ( GTV ) and the postchemotherapy clinical target volume ( CTV ) were first delineated on CT only by the radiation oncologist .


The planning PET was then co-registered , and the delineated volumes were jointly analyzed by the radiation oncologist and the nuclear medicine physician .


Lymph nodes undetected on CT but FDG-avid were recorded , and the previously determined GTV and CTV were modified according to FDG-PET results .


From March 2007 to February 2010 , 135 patients were included in the study .


PET-CT identified at least 1 additional FDG-avid lymph node in 95 of 135 patients ( 70.4 % ; 95 % confidence interval [ CI ] : 61.9 % -77.9 % ) and 1 additional lymph node area in 55 of 135 patients ( 40.7 % ; 95 % CI : 32.4 % -49.5 % ) .


The mean increases in the GTV and CTV were 8.8 % and 7.1 % , respectively .


The systematic addition of PET to CT led to a CTV increase in 60 % of the patients .


Pre-chemotherapy FDG-PET leads to significantly better INRT delineation without necessarily increasing radiation volumes .


Older cancer survivors are a vulnerable population due to an increased risk for chronic diseases ( e.g. , cardiovascular disease ) compounded with treatment late-effects and declines in physical functioning .


Therefore , interventions that reduce chronic disease risk factors ( i.e. , blood pressure , chronic inflammation , and cortisol ) are important in this population .


Tai chi chih ( TCC ) is a mind-body exercise associated with reductions in chronic disease risk factors , but has not been examined with older cancer survivors .


In a feasibility randomized controlled trial of TCC , we examined secondary outcomes of blood pressure , salivary cortisol , and inflammatory cytokines ( interleukin ( IL ) -6 , IL-12 , tumor necrosis factor - , IL-10 , IL-4 ) due to their implications in chronic diseases .


Sixty-three senior female cancer survivors ( M age = 67 years , SD = 7.15 ) with physical functioning limitations ( SF-12 physical functioning 80 or role-physical 72 ) were randomized to 12-weeks ( 60-min , three times a week ) of TCC or Health Education control ( HEC ) classes .


Resting blood pressure , 1-day salivary cortisol samples , and fasting plasma samples for cytokine multiplex assays were collected at baseline and 1-week post-intervention .


Controlling for baseline values , the TCC group had significantly lower systolic blood pressure ( SBP , p = 0.002 ) and cortisol area-under-curve ( AUC , p = 0.02 ) at post-intervention than the HEC group .


There was no intervention effect on inflammatory cytokines ( p 's > 0.05 ) .


This TCC feasibility trial was associated with significant reductions in SBP and cortisol AUC in senior female cancer survivors .


Larger , definitive trials are needed to confirm these findings .


Senior survivors ' have an increased risk for chronic diseases ; however , TCC interventions may help reduce associated risk factors .


Computer-aided design and computer-aided manufacturing ( CAD/CAM ) generated restorations are gaining popularity .


However , limited clinical evidence is available for single-unit posterior CAD/CAM restorations fabricated with established and newer crown materials .


The purpose of this clinical study was to assess the restoration quality of and gingival response to CAD/CAM fabricated posterior single-tooth restorations with different processing technologies .


Twenty-two individuals in need of posterior complete coverage crowns were recruited under an institutional review board approved protocol .


Teeth were randomized to 1 of 3 groups : metal ceramic , lithium disilicate , and monolithic zirconia .


An unprepared or minimally restored tooth on the contralateral side was chosen as a control tooth for gingival measurements with each participant .


Teeth were prepared and scanned intraorally by 1 of 3 experienced practitioners .


A total of 32 restorations were digitally designed and fabricated with either milling technology or rapid-prototype printing and casting with conventional porcelain application .


Restorations were evaluated with modified United States Public Health Service criteria for contour , marginal adaptation , occlusion , and shade .


Gingival crevicular fluid volume and bleeding on probing were recorded preoperatively , at 1-month and 6-month postcementation visits .


Polyvinyl siloxane impressions were made of the buccal margin of cemented restorations and evaluated with microcomputed tomography to assess marginal adaptation ( horizontal discrepancy ) .


The Mantel Haenszel row mean score was used to assess whether the crown systems differed with respect to the modified United States Public Health Service criteria .


Linear mixed models were used to assess whether the average gingival volumes were affected by the explanatory variables ( crown system , tooth status [ treated vs control ] , or visit ) .


A generalized estimating equation approach was used to assess whether bleeding on probing was affected by the explanatory variables .


One-way ANOVA was used to assess marginal discrepancy values among the crown systems ( = .05 for all tests ) .


Twelve metal ceramic , 10 lithium disilicate , and 10 zirconia restorations were fabricated for 22 participants .


Zirconia restorations were significantly different from the other 2 crown systems ( P < .001 ) with respect to occlusion .


No occlusal adjustment was needed on 80 % of the zirconia restorations .


The average gingival crevicular fluid volumes did not differ among crown systems , between treated and control groups , or over time .


The average horizontal marginal discrepancy was significantly different between lithium disilicate and zirconia crowns ( P = .027 ) , with zirconia crowns having the least amount of horizontal marginal discrepancy .


Given the small sample size and limitations of this study , CAD/CAM-generated restorations for posterior teeth made from different materials had acceptable clinical results .


Fluid removal during dialysis , also known as ultrafiltration ( UF ) , leads to intradialytic hypotension ( IDH ) in a significant number of patients treated with hemodialysis ( HD ) and is associated with an increase in morbidity and mortality .


At present , there are no accepted standards of practice for the prevention or treatment of IDH .


Relative blood volume monitoring ( BVM ) is based on the concept that the hematocrit increases with UF , relative to the patient 's baseline hematocrit .


The use of BVM biofeedback , whereby the HD machine automatically adjusts the rate of UF based on the relative blood volume , has been proposed for the prevention of IDH .


This is a 22-week randomized crossover trial .


Participants undergo a 4-week run-in phase to standardize medications and dialysis prescriptions .


Subsequently , participants are randomized to standard HD or to BVM biofeedback for a period of 8 weeks followed by a 2-week washout phase before crossing over .


The dialysis prescription remains identical for both arms .


The primary outcome is the frequency of symptomatic IDH as defined by an abrupt drop in the systolic blood pressure of 20 mm Hg accompanied by headache , dizziness , loss of consciousness , thirst , dyspnea , angina , muscle cramps or vomiting .


Secondary outcomes include the number of symptomatic IDH episodes and any reduction in IDH episodes , nursing interventions , dialysis adequacy , total body water , extra - and intracellular fluid volumes , brain natriuretic peptide and cardiac troponin levels , blood pressure , antihypertensive medication use , patient symptoms and quality of life .


Our study will determine the impact of using BVM biofeedback to prevent IDH and other serious adverse events in susceptible patients .


Clinicaltrials.gov NCT01988181 ( 6 November 2013 ) .


to compare clinical and cost effectiveness of midazolam and diazepam for urgent intubation .


patients admitted to the Central ICU of the Santa Casa Hospital Complex in Porto Alegre , over the age of 18 years , undergoing urgent intubation during 6 months were eligible .


Patients were randomized in a single-blinded manner to either intravenous diazepam or midazolam .


Diazepam was given as a 5 mg intravenous bolus followed by aliquots of 5 mg each minute .


Midazolam was given as an intravenous bolus of 5 mg with further aliquots of 2.5 mg each minute .


Ramsay sedation scale 5-6 was considered adequate sedation .


We recorded time and required doses to reach adequate sedation and duration of sedation .


thirty four patients were randomized , but one patient in the diazepam group was excluded because data were lost .


Both groups were similar in terms of illness severity and demographics .


Time for adequate sedation was shorter ( 132 87 sec vs. 224 117 sec , p = 0.016 ) but duration of sedation was similar ( 86 67 min vs. 88 50 min , p = 0.936 ) for diazepam in comparison to midazolam .


Total drug dose to reach adequate sedation after either drugs was similar ( 10.0 [ 10.0-12 .5 ] mg vs. 15.0 [ 10.0-17 .5 ] mg , p = 0.248 ) .


Arterial pressure and sedation intensity reduced similarly overtime with both drugs .


Cost of sedation was lower for diazepam than for midazolam ( 1.4 [ 1.4-1 .8 ] vs. 13.9 [ 9.4-16 .2 ] reais , p < 0.001 ) .


intubation using intravenous diazepam and midazolam is effective and well tolerated .


Sedation with diazepam is associated to a quicker sedation time and to lower costs .


Intramyocardial bone marrow mononuclear cells ( BMMNC ) implantation concomitant to coronary artery bypass grafting ( CABG ) surgery as an option for regenerative therapy in chronic ischemic heart failure was tested in a very few number of studies , with not consistent conclusions regarding improvement in left ventricular function , and with a follow-up period between 6 months and 1 year .


This study was focused on testing of the hypothesis that intramyocardial BMMNC implantation , concomitant to CABG surgery in ischemic cardiomyopathy patients , leads to better postoperative long-term results regarding the primary end-point of conditional status-functional capacity and the secondary endpoint of mortality than CABG surgery alone in a median follow-up period of 5 years .


A total of 30 patients with ischemic cardiomyopathy and the median left venticular ejection fraction ( LVEF ) of 35.9 4.7 % were prospectively and randomly enrolled in a single center interventional , open labeled clinical trial as two groups : group I of 15 patients designated as the study group to receive CABG surgery and intramyocardial implantation of BMMNC and group II of 15 patients as the control group to receive only the CABG procedure .


All the patients in both groups received the average of 3.4 0.7 implanted coronary grafts , and all of them received the left internal mammary artery ( LIMA ) to the left anterior descending ( LAD ) and autovenous to other coronaries .


The group with BMMNC and CABG had the average of 17.5 3.8 injections of BMMNC suspension with the average number of injected bone marrow mononuclear cells of 70.7 32.4 x 10 ( 6 ) in the total average volume of 5.7 1.5 mL .


In this volume the average count of CD34 + and CD133 + cells was 3.96 2.77 x 10 ( 6 ) and 2.65 1.71 x 10 ( 6 ) , respectively .


All the patients were followed up in 2.5 to 7.5 years ( median , 5 years ) .


At the end of the follow-up period , siginificantly more patients from the group that received BMMNC were in the functional class I compared to the CABG only group ( 14/15 vs 5/15 ; p = 0.002 ) .


After 6 months the results on 6-minute walk test ( 6-MWT ) were significantly different between the groups ( 435 m in the BMMNC and CABG group and 315 m in the CABG only group ; p = 0.001 ) , and continued to be preserved and improved on the final follow-up ( 520 m in the BMMNC and CABG group vs 343 m in the CABG only group ; p < 0.001 ) .


Cardiovascular mortality was also significantly reduced in the BMMNC and CABG group ( p = 0.049 ) .


Implanatation of BMMNC concomitant to CABG is a safe and feasible procedure that demonstates not only the improved functional capacity but also a reduced cardiac mortality in a 5-year follow-up in patients with ischemic cardiomyopathy scheduled for CABG surgery .


The oral factor Xa inhibitor edoxaban has demonstrated safety and efficacy in stroke prevention in patients with atrial fibrillation and in the treatment and secondary prevention of venous thromboembolism .


This study investigated the reversal of edoxaban 's effects on bleeding measures and biomarkers by using a 4-factor prothrombin complex concentrate ( 4F-PCC ) .


This was a phase 1 study conducted at a single site .


This was a double-blind , randomized , placebo-controlled , 2-way crossover study to determine the reversal effect of descending doses of 4F-PCC on bleeding duration and bleeding volume following edoxaban treatment .


A total of 110 subjects ( 17 in part 1 , 93 in part 2 ) were treated .


Intravenous administration of 4F-PCC 50 , 25 , or 10 IU/kg following administration of edoxaban ( 60 mg ) dose-dependently reversed edoxaban 's effects on bleeding duration and endogenous thrombin potential , with complete reversal at 50 IU/kg .


Effects on prothrombin time were partially reversed at 50 IU/kg .


A similar trend was seen for bleeding volume .


The 4F-PCC dose-dependently reversed the effects of edoxaban ( 60 mg ) , with complete reversal of bleeding duration and endogenous thrombin potential and partial reversal of prothrombin time following 50 IU/kg .


Edoxaban alone and in combination with 4F-PCC was safe and well tolerated in these healthy subjects .


A dose of 50 IU/kg 4F-PCC may be suitable for reversing edoxaban anticoagulation .


http://www.clinicaltrials.gov .


Unique identifier : NCT02047565 .


The NCIC CTG PR3/MRC PR07 randomized phase III trial compared androgen-deprivation therapy ( ADT ) alone versus ADT with radiotherapy ( RT ) for patients with locally advanced prostate cancer .


This article reports the health-related quality-of-life ( HRQOL ) outcomes of this trial .


A total of 1,205 patients were randomly allocated to either ADT alone or ADT with RT. .


HRQOL was assessed at baseline and every 6 months thereafter using the European Organisation for Research and Treatment of Cancer Core Questionnaire and a prostate cancer-specific checklist or the Functional Assessment of Cancer Therapy-Prostate questionnaire .


Mean changes from baseline scores for five function domains and nine symptom domains were analyzed as those most relevant to ADT and RT. .


The proportions of patients with improved , stable , or worsened HRQOL scores according to instrument-specific minimal important differences were calculated .


Baseline questionnaires were completed by 1,028 patients ( 88 % ) .


At 6 months , RT had a statistically significant impact on mean score for bowel symptoms ( P = .02 ) , diarrhea ( P < .001 ) , urinary function ( P = .003 ) , and erectile dysfunction ( P = .008 ) ; by 3 years , however , there were no significant between-group differences in any domain .


Generalized linear mixed modeling revealed no significant between-arm differences in any of the function scales but showed significant deterioration in both arms over time for Functional Assessment of Cancer Therapy-Prostate total score , treatment outcome index , and physical and functional well-being .


The addition of RT to ADT for patients with locally advanced prostate cancer significantly improved overall survival and had only modest and transient negative impact on relevant domains of HRQOL .


To evaluate the effectiveness of a capacity-building intervention administered through a primary health care ( PHC ) system on community disaster preparedness in Iran .


A controlled community intervention trial with pre - and postassessments was conducted in 2011 in 3 provinces of Iran .


In each province , 2 areas were chosen and randomly selected as an intervention or control group .


A total of 9200 households were in the intervention area and 10 010 were in the control area .


In each study group in each province 250 households were sampled for pre - and postassessment surveys .


Community health volunteers led by PHC staff administered an educational intervention covering elements of hazard awareness and preparedness , with a focus on earthquakes and floods .


Relative changes for awareness and readiness scores were assessed to demonstrate changes in outcome variables from pre - to postassessments in intervention and control groups .


An effectiveness test of significance was based on interaction between time and area .


Households in intervention communities exhibited improved disaster awareness and readiness with respect to all outcome measures .


Relative changes in awareness in intervention and control areas were 2.94 and -0.08 , respectively ( P < .001 ) .


Relative changes for readiness scores were 5.52 in intervention areas and 0.56 in control areas ( P < .001 ) .


Relative changes for awareness and readiness were significantly correlated with a community 's baseline risk perception and previous experience with natural disasters ( P < .001 ) .


An educational intervention administered through the PHC system effectively improved disaster awareness and readiness at a community level .


For sustainability , community disaster reduction programs must be integrated into routine public health service delivery .


Preoperative oral rehydration solution ( ORS ) prevents dehydration before surgery .


Therefore taking enough ORS possibly reduces the hemodynamic changes during induction of anesthesia , and reduces the amount of fluid needed during anesthesia .


Forty patients undergoing elective surgery were randomly assigned to two groups : drinking 1,500 ml ORS 6 to 2 hours before anesthesia ( ORS group ) and nothing by mouth from 6 hours before anesthesia ( Control group ) .


Anesthesia induction was performed using propofol and remifentanil .


To evaluate the hemodynamic changes , hemodynamic parameters including heart rate , blood pressure , cardiac index ( CI ) , and stroke volume variation ( SVV ) were recorded before induction , after propofol administration , and after remifentanil administration .


Total urine volume and the amount of fluid were also recorded at the end of the anesthesia .


In ORS group , CI showed a significantly higher value after propofol administration ( P = 0.046 ) .


SVV was significantly lower ( P < 0.0001 ) and total amount of fluid during anesthesia was significantly reduced ( P < 0.0001 ) in ORS group .


Preoperative oral rehydration increases circulating blood volume , it keeps high CI during induction of anesthesia , and reduces the amount of intraoperative fluid .


Perioperative prophylactic antibiotic treatment significantly influences intestinal microflora , resulting in impaired bowel functioning in some patients , sometimes requiring further investigations .


This may lead to a worse health-related quality of life ( HRQoL ) .


Probiotics administrated in the early post-operative period may help avoiding such nuisances in older people .


We prospectively enrolled patients undergoing laparoscopic colorectal surgery aged over 70 years between 2005 and 2012 .


The study was approved by IRB .


All patients received perioperative antibiotic treatment .


Patients were randomized to one of two treatment arms : Group A patients received probiotics after surgery ( VSL # 3 , VSL Pharmaceuticals , Inc. .


USA - 900 109 daily , while Group B patients received a Placebo ( cornstarch ) .


Patients were further divided in sub-groups whether ileo-caecal valve was spared or not .


Patients were followed-up every 7 days for 4 weeks .


Patients daily annotated bowel frequency , stool shape and consistency - according to Bristol 's scale .


HRQoL was assessed every week by means of SF-36 questionnaire .


Group A included 10 while Group B included 8 patients .


One patient in each group experienced a postoperative complication .


Group A patients had fewer bowel movements than controls , during every week .


Stool consistency was higher in patients undergoing resections including ileo-caecal valve receiving VSL # 3 .


HRQoL gradually increased in both groups ; Group A patients had higher `` social functioning '' item scores at week 1 and 4 than controls .


Elderly patients undergoing resection of ileo-caecal valve may benefit from an early probiotics administration pathway after perioperative antibiotic treatment .


To evaluate the 10-year durability of a nanohybrid resin composite in Class II restorations in a randomized controlled intraindividual comparison with its conventional hybrid resin composite predecessor .


Each of 52 participants received at least two Class II restorations that were as similar as possible .


The cavities were chosen at random to be restored with a nanohybrid resin composite ( Excite/Tetric EvoCeram ( TEC ) ; n = 61 ) and a conventional hybrid ( Excite/Tetric Ceram ( TC ) ; n = 61 ) .


The restorations were evaluated with slightly modified USPHS criteria at baseline and then annually for 10 years .


The overall performance of the experimental restorations was tested after intra-individual comparison and their ranking was tested using Friedman 's two-way ANOVA .


The level of significance was set at 5 % .


Four patient drop-outs with 8 restorations ( 4TEC , 4TC ) were registered during the follow-up .


A prediction of the caries risk showed that 16 of the evaluated 52 patients were considered as high risk patients .


In total , 22 restorations , 11 TEC ( 3 premolars , 8 molars ) and 11 TC ( 3 premolars , 8 molars ) restorations failed during the 10 years .


The main reason for failure was secondary caries ( 50 % ) .


63 % of the recurrent caries lesions were found in high caries risk participants .


The overall success rate at 10 years was 80.7 % , with an annual failure rate of 1.9 % .


No statistically significant difference was found in the overall survival rate between the two investigated resin composites .


The nanohybrid and the conventional hybrid resin composite showed good clinical effectiveness in extensive Class II restorations during the 10-year study .


To evaluate the efficacy and safety of intravitreal aflibercept injection ( IAI ) for the treatment of macular edema secondary to central retinal vein occlusion ( CRVO ) .


Randomized , double-masked , phase 3 trial .


A total of 188 patients with macular edema secondary to CRVO .


Patients received IAI 2 mg ( IAI 2Q4 ) ( n = 114 ) or sham injections ( n = 74 ) every 4 weeks up to week 24 .


During weeks 24 to 52 , patients from both arms were evaluated monthly and received IAI as needed , or pro re nata ( PRN ) ( IAI 2Q4 + PRN and sham + IAI PRN ) .


During weeks 52 to 100 , patients were evaluated at least quarterly and received IAI PRN .


The primary efficacy end point was the proportion of patients who gained 15 letters in best-corrected visual acuity ( BCVA ) from baseline to week 24 .


This study reports week 100 results .


The proportion of patients gaining 15 letters was 56.1 % versus 12.3 % ( P < 0.001 ) at week 24 , 55.3 % versus 30.1 % ( P < 0.001 ) at week 52 , and 49.1 % versus 23.3 % ( P < 0.001 ) at week 100 in the IAI 2Q4 + PRN and sham + IAI PRN groups , respectively .


The mean change from baseline BCVA was also significantly higher in the IAI 2Q4 + PRN group compared with the sham + IAI PRN group at week 24 ( +17.3 vs. -4.0 letters ; P < 0.001 ) , week 52 ( +16.2 vs. +3.8 letters ; P < 0.001 ) , and week 100 ( +13.0 vs. +1.5 letters ; P < 0.0001 ) .


The mean reduction from baseline in central retinal thickness was 457.2 versus 144.8 m ( P < 0.001 ) at week 24 , 413.0 versus 381.8 m at week 52 ( P = 0.546 ) , and 390.0 versus 343.3 m at week 100 ( P = 0.366 ) in the IAI 2Q4 + PRN and sham + IAI PRN groups , respectively .


The mean number ( standard deviation ) of PRN injections in the IAI 2Q4 + PRN and sham + IAI PRN groups was 2.7 1.7 versus 3.9 2.0 during weeks 24 to 52 and 3.3 2.1 versus 2.9 2.0 during weeks 52 to 100 , respectively .


The most frequent ocular serious adverse event from baseline to week 100 was vitreous hemorrhage ( 0.9 % vs. 6.8 % in the IAI 2Q4 + PRN and sham + IAI PRN groups , respectively ) .


The visual and anatomic improvements after fixed dosing through week 24 and PRN dosing with monthly monitoring from weeks 24 to 52 were diminished after continued PRN dosing , with a reduced monitoring frequency from weeks 52 to 100 .


Environmental enteropathy ( EE ) is an asymptomatic abnormality of small bowel structure and function , which may underlie vaccine inefficacy in the developing world .


HIV infection co-exists in many of these populations .


There is currently no effective treatment .


We conducted a secondary analysis of a randomised controlled trial of high dose multiple micronutrient ( MM ) supplementation on small bowel architecture in EE in participants with or without HIV infection .


In a double-blind parallel-group trial of the effect of MM on innate immune responses to oral vaccines , consenting Zambian adults were randomised to receive 6 weeks of 24 micronutrients as a daily capsule or placebo .


HIV status was established after randomisation .


Proximal jejunal biopsies were obtained after the supplementation period .


Villous height , crypt depth , villous width , villous perimeter per 100 m muscularis mucosa ( a measure of epithelial surface area ) , and villous cross sectional area per 100 m muscularis mucosa ( a measure of villous compartment volume ) were measured in orientated biopsy sections using semi-automated image analysis .


Analysis was by intention to treat .


18 patients received MM and 20 placebo .


6/18 MM and 9/20 placebo patients had HIV .


In HIV negative patients given MM compared to placebo , mean villous height was 24.0 % greater ( 293.3 v. 236.6 m ; 95 % CI of difference 17.7-95 .9 m ; P = 0.006 ) , mean villous area was 27.6 % greater ( 27623 v. 21650 m2/100 m ; 95 % CI of difference 818-11130 m2/100 m ; P = 0.03 ) , and median villous perimeter was 29.7 % greater ( 355.0 v. 273.7 m/100 m ; 95 % CI of difference 16.3-146 .2 m/100 m ; P = 0.003 ) .


There was no significant effect on crypt depth or villous width .


No effect was observed in HIV positive patients .


There were no adverse events attributable to MM .


MM improved small bowel villous height and absorptive area , but not crypt depth , in adults with EE without HIV .


Nutritional intervention may therefore selectively influence villous compartment remodelling .


In this small study , there was a clear difference in response depending on HIV status , suggesting that EE with superimposed HIV enteropathy may be a distinct pathophysiological condition .


To test the hypothesis that racial biases in opioid prescribing would be more likely under high levels of cognitive load , defined as the amount of mental activity imposed on working memory , which may come from environmental factors such as stressful conditions , chaotic workplace , staffing insufficiency , and competing demands , one 's own psychological or physiological state , as well as from demands inherent in the task at hand .


Two ( patient race : White vs Black ) by two ( cognitive load : low vs high ) between-subjects factorial design .


Ninety-eight primary care physicians from the Veterans Affairs Healthcare System .


Web-based experimental study .


Physicians were randomly assigned to read vignettes about either a Black or White patient , under low vs high cognitive load , and to indicate their likelihood of prescribing opioids .


High cognitive load was induced by having physicians perform a concurrent task under time pressure .


There was a three-way interaction between patient race , cognitive load , and physician gender on prescribing decisions ( P = 0.034 ) .


Hypotheses were partially confirmed .


Male physicians were less likely to prescribe opioids for Black than White patients under high cognitive load ( 12.5 % vs 30.0 % ) and were more likely to prescribe opioids for Black than White patients under low cognitive load ( 30.8 % vs 10.5 % ) .


By contrast , female physicians were more likely to prescribe opioids for Black than White patients in both conditions , with greater racial differences under high ( 39.1 % vs 15.8 % ) vs low cognitive load ( 28.6 % vs 21.7 % ) .


Physician gender affected the way in which patient race and cognitive load influenced decisions to prescribe opioids for chronic pain .


Future research is needed to further explore the potential effects of physician gender on racial biases in pain treatment , and the effects of physician cognitive load on pain treatment .


Carbon dioxide ( CO2 ) insufflation has been used in endoscopic retrograde cholangiopancreatography ( ERCP ) .


However , its usefulness and safety are controversial in elderly patients .


Our aim was to assess the safety and usefulness of CO2 insufflation during ERCP in elderly patients .


Between April 2010 and June 2011 , a total of 60 patients 75 years old or older , who underwent ERCP , were randomized into the CO2 group ( n = 30 ) and the air group ( n = 30 ) .


Main outcomes were determined by assessing abdominal symptoms according to the Wong-Baker FACES Pain Rating Scale , calculating the volume of residual gas retention within the intestines on abdominal X-ray quantitatively and observing the cardiopulmonary states .


30 patients in the CO2 group and 30 patients in the air group were analyzed .


Abdominal distension ( P < 0.01 ) , discomfort ( P < 0.01 ) and nausea ( P < 0.01 ) at 2 hours after ERCP were significantly reduced in the CO2 group .


The gas volume scores immediately after ERCP ( P < 0.01 ) and at 2 hours ( P < 0.01 ) were significantly lower in the CO2 group .


CO2 insufflation instead of air insufflation is safe and useful for the prevention of post-ERCP abdominal symptoms in elderly patients .


For ethnic minority families , the bridging of clinician-client differences is essential to their engagement in treatment .


The Culturally Enhanced Video Feedback Engagement ( CEVE ) intervention aims to enhance client engagement through fostering clinician-client shared cultural understanding .


The present study tested the effectiveness of the CEVE on client-rated clinician cultural competence and therapeutic alliance .


Nineteen ethnic minority families with children aged 3-6 years were randomized to the CEVE ( n = 9 ) or treatment as usual ( n = 10 ) at an outpatient clinic .


Results from linear mixed effects regression models indicated a significant effect of the CEVE on intercept , suggesting that clinician cultural competence and therapeutic alliance were significantly higher in the CEVE condition .


No effect was found for clinician growth in skills .


The results indicate that the CEVE enhances client treatment engagement via clinician cultural competence and clinician-client alliance , suggesting its promise as a clinical engagement tool , particularly for treatments serving ethnic minority families .


Antenatal care ( ANC ) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses , and indirectly through the detection of women at increased risk of delivery complications .


The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher.WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal , perinatal and neonatal outcomes .


The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique .


The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country .


This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design .


The intervention was tailored , based on formative research findings , to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers .


The intervention includes four components : the provision of kits with all necessary medicines and laboratory supplies for ANC ( medical and non-medical equipment ) , a storage system , a tracking system , and training sessions for health care providers .


Ten clinics were selected and will start receiving the intervention in a random order .


Outcomes will be computed at each time point when a new clinic starts the intervention .


The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit , and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practices .


This demonstration project is pragmatic in orientation and will be conducted under routine conditions .


There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries .


This can only be accomplished by the engagement of the country 's health stakeholders at all levels .


This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels : policy , organizational and health care delivery levels .


The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in ` habits ' will contribute to obtaining reliable health indicators , not only related to research issues , but also to health care outcomes derived from the new health care model .


At policy level , the results of this study may suggest a need for revision of the supply chain management system .


Given that supply chain management is a major challenge for many low-resource countries , we envisage that important lessons on how to improve the supply chain in Mozambique and other similar settings , will be drawn from this study .


Pan African Clinical Trial Registry database .


Identification number : PACTR201306000550192 .


The number of older adults using wheelchairs in nursing homes is over 50 % of that population , and many of them use wheelchairs due to muscle weakness in the lower extremities .


Muscles of older adults are trainable , and progressive resistance exercises using elastic bands can increase muscle strength in older adults .


To test the effectiveness of six-month Wheelchair-bound Senior Elastic Band exercises on the functional fitness of older adults in nursing homes .


Cluster randomized trial .


Ten nursing homes , southern Taiwan .


127 participants were recruited , and 114 of them completed the study .


Inclusion criteria were : ( 1 ) aged 65 and over , ( 2 ) using wheelchairs for mobility , ( 3 ) living in the facility for at least three months , ( 4 ) cognitively intact , and ( 5 ) heavily or moderate dependency in their activities of daily living .


The mean age of the participants was 79.15 ( 7.03 ) years , and 98.20 % of them had chronic illnesses .


Participants were randomly assigned to the experimental ( five nursing homes , n = 59 ) or the control ( five nursing homes , n = 55 ) group based on the nursing homes where they stayed .


A 40-min Wheelchair-bound Senior Elastic Band exercise program was implemented three times per week for six months for the experimental group participants .


The functional fitness ( activities of daily living , lung capacity , body flexibilities , muscle power and endurance ) of the participants was examined at baseline , after three months , and at the end of the six months study .


The mixed-design , two-way analysis of variance was used to detect the interaction effects , and one-way repeated measures analysis of variance and analysis of covariance were performed to analyze the within-group and between-group differences .


At the end of the six-month study , the Wheelchair-bound Senior Elastic Band group had better performances in all of the functional fitness indicators than the control group ( all p < 0.05 ) .


The Wheelchair-bound Senior Elastic Band exercises significantly improved the functional fitness of the older adults in wheelchairs .


It is suggested that the program be incorporated as a part of daily activities for nursing home older adults in wheelchairs .


To provide a new surgical technique for epididymal cyst ( EC ) treatment and to assess its safety and efficiency .


Forty-eight patients with symptomatic EC were randomized into 2 groups .


One group ( n = 23 ) received traditional open epididymal cystectomy ( OEC ) and the other group ( n = 25 ) underwent minimal epididymal cystectomy with scrotoscope ( MECS ) , which provided a clear vision of scrotal contents .


Demographic information and perioperative and postoperative outcomes data were obtained and analyzed during a 2 - to 6-month follow-up .


No significant differences between the OEC and MECS groups were found in demographic information .


Compared with OEC group , the MECS group had a shorter operating time ( 18.6 2.9 vs 54.5 7.0 minutes ; P < .05 ) , shorter incision length ( 1.1 0.2 vs 4.8 0.6 cm ; P < .05 ) , and less blood loss ( 4.6 1.6 vs 17.0 3.1 g ; P < .05 ) .


Except for the 8.0 % rate ( 2 of 25 ) of scrotal edema after MECS and 17.4 % rate ( 4 of 23 ) of scrotal hematoma after OEC , both groups resulted in 0 % incidence of testis or epididymis injury , wound infection , and cyst recurrence based on postoperative outcome data .


Significant differences were observed after MECS compared with those after OEC based on the rates of symptom relief ( 95.2 % vs 61.1 % ; P < .05 ) and days of wound pain ( 12.1 2.6 vs 17.7 4.1 days ; P < .05 ) .


For the first time , our study applied scrotoscope as a new alternative technique for EC treatment .


Scrotoscope provides a clear field of vision and makes tissues harvested available for pathologic examination when performing decortications of EC .


The results suggest MECS may be a safe , effective , and encouraging new technique .


This study was conducted to examine the effects of weight reduction on proteinuria , adipokines , and renal function in overweight immunoglobulin A nephropathy ( IgAN ) patients ( body mass index > 23 kg/m2 ) with chronic proteinuria more than 6 months .


This was a single-center , prospective , randomized controlled trial .


The study was performed at the outpatient clinic at King Chulalongkorn Memorial Hospital , Bangkok , Thailand , from July 2012 to February 2013 .


Twenty-six overweight patients with chronic proteinuric biopsy-proven IgAN were randomized into a control group ( n = 13 ) or a low-calorie normal protein diet group ( n = 13 ) .


All patients received the maximum dosage of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker and other antihypertensive agents to achieve a blood pressure less than 125/75 mmHg .


The study intervention was a low-calorie diet ( target energy per day as 500-kcal subtraction from total energy requirement ) for a 6-month period .


At baseline and after 6 months of a low-calorie diet , body weight , body content , and clinical and laboratory parameters were determined and compared .


After initiating a low-calorie diet for 6 months , the normalized protein nitrogen appearance values were not different , indicating comparable protein intake .


The low-calorie group had lower total daily calorie intake ( 1,307.1 171.8 vs. 1,772.2 315.4 kcal/d , P < .01 ) and significant reductions in body weight ( -5.1 3.3 % , P < .001 ) , fat content ( -12.7 14.1 % , P < .05 ) , and 24-hour urine protein ( -45.2 15.4 % , P < .001 ) .


Blood pressure and renal function parameters were unaltered .


The low-calorie group had approximately 20 % lower plasma levels of leptin but unchanged adiponectin .


There were positive correlations between the amount of protein reduction and the changes of body weight , fat mass , and leptin .


A 6-month low-calorie diet leads to weight reduction and results in diminished fat content and decreased proteinuria in overweight IgAN patients with chronic proteinuria .


This beneficial effect might be mediated by changes in adipokines .


This study provides insight into the long-term efficacy ( i.e. 12 month results ) of the Web-based or print-delivered tailored Active Plus intervention ( with and without environmental approach ) to promote physical activity ( PA ) among the over-fifties .


Differences in effect among subgroups are studied as well .


Intervention groups ( i.e. print-delivered basic ( PB ; N = 439 ) , print-delivered environmental ( PE ; N = 435 ) , Web-based basic ( WB ; N = 423 ) , Web-based environmental ( WE ; N = 432 ) ) and a waiting list control group ( N = 411 ) were studied in a clustered randomized controlled trial .