( @ ) NRS score at @ min after acu puncture in the control group was obviously lower than that in the observation group ( P < @ ) , but the scores in @ h , @ h , @ h and @ h after acupuncture in the observation group were lower apparently than those in the control group ( all P < @ ) .


The differences in the scores in @ min , @ min , @ min and @ h after acupuncture were not significant ( all P > @ ) .


( @ ) For the reducing amplitude of NRS score at the same time point after acupuncture , the results in @ min , @ min and @ h in the control group were higher apparently than those in the observation group ( all P < @ ) .


But , in @ h , @ h , @ h and @ h , the results in the observation group were higher apparently than those in the control group ( all F < @ ) .


The differences in @ min and @ min after acupuncture were not significant ( both P > @ ) .


( @ ) In @ h after acupuncture , the recurrence rate of migraine was @ % ( @/@ ) in the observation group , which was lower obviously than @ % ( @/@ ) in the control group ( P < @ ) .


The adverse reaction was not found in the two groups .


EA at the shaoyang meridian points achieves the definite immediate analgesia effect on acute migraine and presents the time effectiveness of analgesia .


This study aimed to assess the effectiveness of a blended-teaching intervention using Internet-based tutorials coupled with traditional lectures in an introduction to research undergraduate nursing course .


Effects of the intervention were compared with conventional , face-to-face classroom teaching on three outcomes : knowledge , satisfaction , and self-learning readiness .


A two-group , randomized , controlled design was used , involving @ participants .


Descriptive statistics and analysis of covariance ( ANCOVA ) were performed .


The teaching method was found to have no direct impact on knowledge acquisition , satisfaction , and self-learning readiness .


However , motivation and teaching method had an interaction effect on knowledge acquisition by students .


Among less motivated students , those in the intervention group performed better than those who received traditional training .


These findings suggest that this blended-teaching method could better suit some students , depending on their degree of motivation and level of self-directed learning readiness .


Vessel wall injury after drug-eluting stent ( DES ) implantation can be characterized in detail by optical coherence tomography ( OCT ) .


Little is known about the healing course of these phenomena .


In @ lesions ( @ patients ) , the incidence of acute vessel trauma was assessed in the stented region and the edge segments immediately after DES implantation .


The healing course of these injuries was assessed at @-month OCT follow-up using a software algorithm allowing for reliable spatial comparison of baseline and follow-up cross-sectional images .


Tissue prolapse ( TP ) and tissue protrusions were detected in @ and @ % of lesions , respectively .


A total of @ intra-stent dissection flaps ( ISD ) and @ intra-stent dissection cavities ( ISC ) were visualized in @ and @ % of lesions , respectively .


Thirty-five lesions ( @ % ) showed edge dissections ( EDs ) .


No residual TP or protrusion was observed at follow-up .


Incomplete healing was seen in @ % of ISD and in @ % of ISC .


For ED , a residual flap was observed in one-third of the initially dissected stent edges .


Incomplete healing of acute vessel injury was associated with the presence of underlying atherosclerotic disease at baseline .


Uncovered and malapposed stent struts were observed more often with incomplete healing of vessel injury at follow-up .


Acute vessel wall trauma is highly prevalent immediately after DES implantation .


Most of these injuries are minor and resolve at mid-term follow-up .


Incomplete healing of ISDs seems to be associated with other OCT findings suggesting delayed arterial healing .


We hypothesized that integrated motor-visual functions measured by manipulative manual dexterity are affected by white matter lesion ( WML ) burden as measured on cranial MRI across relevant brain regions in subjects at risk of preclinical occult vascular disease .


A real-time cross-sectional study of healthy subjects aged @ to @ years with a family history of early-onset coronary artery disease ( n = @ ; mean age , @ @ years ; mean education , @ @ years ; @ % male ; @ % black ) were identified from probands with coronary artery disease diagnosed before age @ years .


WMLs on @-tesla brain MRI and Grooved Pegboard scores were measured .


WMLs were observed at all ages .


Mean pegboard scores were @ @ , similar to normal populations .


In unadjusted analysis , WMLs and pegboard scores were significantly correlated by region ( total WMLs , r = @ , p = @ ; frontal -LSB- r = @ , p < @ -RSB- , insula -LSB- r = @ , p < @ -RSB- , parietal -LSB- r = @ , p < @ -RSB- , and temporal -LSB- r = @ , p < @ -RSB- ) .


In multivariate analysis predicting ( log ) pegboard score adjusted for age , sex , race , education , regional or total volumes , and familial non-independence , total WML volume ( p = @ E - @ ) and regional WML volumes ( p < @ ) retained statistical significance in all but the youngest age quartile ( @-@ years ) .


Greater WML volumes in different brain regions are associated with higher pegboard scores ( worse performance ) independent of age , sex , race , education , and total or regional volumes .


This suggests that small vessel cerebrovascular disease may be present in healthy individuals in a preclinical state with measurable impact on complex integrative functions in individuals with excess risk of clinical vascular disease .


We examined the durability of the virological response after discontinuing lamivudine ( LVD ) in chronic hepatitis B ( CHB ) patients with LVD-resistant hepatitis B virus ( HBV ) , who responded to LVD plus adefovir ( ADV ) combination therapy , and the outcome of switching to ADV monotherapy compared to maintaining combination therapy .


This study enrolled @ patients with undetectable viral loads ( @ IU/ml ) and normal alanine aminotransferase levels after ADV add-on therapy for at least @ months in LVD-resistant CHB patients .


The enrolled patients were randomly assigned to continue with LVD-ADV combination therapy or switch to ADV monotherapy ( n = @ per group ) .


Virological rebound was defined as HBV DNA detection at more than @ IU/ml by quantitative polymerase chain reaction determined on two consecutive measurements .


During @ weeks of follow-up , @ % ( @/@ ) of the patients in the LVD-ADV combination maintained group had persistently undetectable HBV DNA , compared with @ % ( @/@ ) patients in the ADV monotherapy switched group .


These two patients had undetectable HBV DNA after switching back to LVD-ADV combination therapy .


There were no significant differences in the HBsAg levels between the two treatment groups during the @-week follow-up period .


In our study , switching to ADV monotherapy resulted in sustained HBV DNA suppression in @ % of the patients for @ weeks .


Prior complete viral suppression with LVD-ADV combination therapy conferred a significant advantage in patients who switched to ADV monotherapy .


LVD may be discontinued in patients who show a complete virological response to LVD-ADV combination therapy for at least @ months .


Rapid travel over multiple time zones usually results in transient de-synchronization between environmental time and the biological clock of the individual .


Common symptoms are increased daytime sleepiness , reduced sleep duration and quality , and performance impairments .


Exposure to ocular bright light is known to alleviate jet lag symptoms and facilitate adaptation to a new time zone .


Recently , transcranial bright light ( TBL ) via the ear canals has been shown to have antidepressant , anxiolytic , and psychomotor performance-enhancing effects .


In this case we studied whether intermittent TBL exposure can alleviate jet lag symptoms in a randomized , double-blind , placebo-controlled study .


Intermittent light exposures ( @ @ min ; day @ : @:@ , @:@ , @:@ , @:@ ; days @-@ : @:@ , @:@ , @:@ , @:@ ) were administered during the @-d post-travel period after an eastward transatlantic flight .


The symptoms of jet lag were measured by the Visual Analog Scale ( VAS ) , the Karolinska Sleepiness Scale ( KSS ) , and the Profile of Mood States ( POMS ) .


We found a significant reduction of overall jet lag symptoms ( VAS ) , subjective sleepiness ( KSS ) , and the fatigue , inertia , and forgetfulness subscales of the POMS when comparing the active TBL treatment group ( N = @ ) to the placebo group ( N = @ ) .


For example , the normalized values of VAS in the TBL , but not the placebo , group returned to pre-travel levels by the final post-travel day ( @ vs. @ ) .


Results suggest a cumulative effect of TBL , as the effects emerged on post-travel days @-@ .


Intermittent TBL seems to alleviate jet lag symptoms .


To explore the effects of penehyclidine inhalation on the incidence of pulmonary complications in elderly patients after long-duration surgery .


For this prospective , double-blind and randomized controlled trial , @ elderly patients undergoing long-duration surgery ( @ hours ) under general anesthesia and transferred into intensive care unit ( ICU ) of Peking University First Hospital during February @ , @ to September @ , @ were enrolled .


After extubation , they were randomized into @ groups to receive an inhalation of penehyclidine hydrochloride , ipratropium bromide or normal saline for @ consecutive days .


The primary endpoint was the incidence of pulmonary complications within @ days post-extubation .


The incidence of bronchospasm was @ % , @ % and @ % respectively .


And the rate of aminophylline use was @,@ and @ % respectively ( P = @ and P = @ ) ; the airway tract spasm-free duration within @ days after extubation was @ ( @-@ @ ) , @ ( @-@ @ ) and @ ( @-@ @ ) days ( P = @ ) ; the overall incidence of pulmonary complications was @ % , @ % and @ % ( P = @ ) .


For elderly patients after long-duration surgery , a prophylactic atomizing inhalation of penehyclidine decreases the incidence of bronchospasm and the rate of aminophylline use after extubation.However , the overall incidence of pulmonary complications has no change .


Offering the overweight or obese patient the option of choosing from a selection of weight loss diets has not been investigated in type @ diabetes .


The aim of the study was to investigate if the option to choose from , and interchange between a selection of diets ( `` Choice '' ) , as opposed to being prescribed one set diet ( `` No Choice '' ) , improves drop out rates and leads to improved weight loss and cardio-metabolic outcomes .


The study was a @month , randomized parallel intervention .


A total of @ volunteers with type @ diabetes or pre-diabetes and a BMI > @ were randomized to `` No Choice '' or `` Choice '' .


Those in the No Choice group were placed on a set weight loss diet ( CSIRO ) with no change permitted .


Those in the Choice group could choose from , and interchange between , the CSIRO , South Beach or Mediterranean diets .


There were no differences in attrition rates or weight loss between the `` Choice '' and `` No Choice '' .


In a secondary analysis of the intention-to-treat weight loss data with last measured weight carried forward gave a highly significant diet group by time by gender interaction ( p = @ ) with men doing better in the No Choice group overall ( maximum difference `` No Choice '' -@ kg vs. `` Choice '' -@ kg@ @ kg at @months ) and women doing better in the Choice group overall ( maximum difference Choice -@ kg vs. `` No Choice '' -@ kg@ @ kg at @months ) .


Men prefer direction in their weight loss advice and do less well with choice .


A gender-specific approach is recommended when prescribing weight loss diets .


To determine if the location of neodymium : yttrium-aluminum-garnet laser peripheral iridotomy ( LPI ) is related to the occurrence of postoperative visual dysphotopsia .


Randomized , prospective , single-masked , paired-eye comparative clinical trial .


setting : Private subspecialty clinic in Mississauga , Canada .


study population : Patients with primary angle closure or primary angle-closure suspects were recruited and randomized to receive LPI temporally in one eye and superiorly in the other .


Patients were masked to the location of treatment in each eye .


intervention : Temporal or superior LPI .


main outcome measures : Occurrence of new-onset linear dysphotopsia .


Other visual disturbances also were assessed using a questionnaire before and @month after intervention .


Secondary outcome measures included eyelid position , laser parameters , and any intraoperative complications .


A total of @ patients were recruited to the study , of which @ ( @ % ) completed it .


New-onset linear dysphotopsia was reported in @ ( @ % ) eyes with superior LPI versus @ ( @ % ) eyes with temporal LPI ( P = @ ) .


Eleven eyes ( @ % ) with superior LPI reported linear dysphotopsia despite complete eyelid coverage of the iridotomy .


No significant differences were found with other visual disturbances between them .


There was more pain experienced by the temporal LPI ( @ @ vs @ @ ; P = @ ) , despite no difference in laser energy or number of shots .


Intraoperative rates of hemorrhage were similar ( @ % vs @ % ; P = @ ) .


Temporal placement of LPI is safe and was found to be less likely to result in linear dysphotopsia as compared with superior placement .


Temporal iris therefore may be considered a preferred location for LPI .


To examine the functional status ( mental health , academic performance , peer problems ) of a community-based sample of children who have attention-deficit/hyperactivity disorder ( ADHD ) and non-ADHD controls , and to investigate gender and subtype differences .


Children aged @ to @ years were recruited through @ Melbourne schools , using a @-stage screening ( parent and teacher Conners @ ADHD index ) and case confirmation ( Diagnostic Interview Schedule for Children , Version IV ; -LSB- DISC-IV -RSB- ) procedure .


Outcome measures were mental health disorders ( DISC-IV ) , academic performance ( Wide Range Achievement Test @ ) , and peer problems ( Strength and Difficulties Questionnaire ) .


Unadjusted and adjusted linear and logistic regression were used to compare ADHD and non-ADHD controls .


A total of @ children who have ADHD and @ non-ADHD controls were recruited .


Compared with controls , children who had ADHD had higher odds of externalizing ( odds ratio -LSB- OR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P < @ ) and internalizing ( OR , @ ; @ % CI , @-@ @ ; P = @ ) disorders ; poorer reading ( effect size , -@ ) and mathematics ( effect size , -@ ) performance ; and more peer problems ( P < @ ) .


Boys and girls who had ADHD were equally impaired .


Only @ % of children in our ADHD group had been previously diagnosed .


Previous diagnosis was higher in the Combined group and for boys .


In their second year of school , children who had ADHD performed worse than controls across all functional domains , yet only a minority had been formally diagnosed with ADHD .


Findings highlight the need for earlier diagnosis and intervention .


Assessment of symptoms and rescue medication use are well-established endpoints for clinical trials evaluating asthma treatment .


To evaluate the measurement properties of an asthma symptom and rescue medication use ( ASRMU ) diary for clinical trials involving asthma patients aged @ years .


Interviews with @ patients were conducted to confirm the importance of key concepts in the ASRMU diary .


Scores of symptom and rescue medication use were converted to symptom-free days ( SFD ) and rescue-free days ( RFD ) .


Test-retest reliability and equivalence ( based on intra-class correlation coefficients -LSB- ICCs -RSB- ) between paper-and-pencil and electronic ( eDiary ) versions were evaluated in a prospective study in @ patients .


Responsiveness of the ASRMU diary was evaluated through differences in percentage of SFD and of RFD by treatment group in eight asthma clinical trials that assessed inhaled corticosteroids ( ICS ) and long-acting @-agonists ( LABA ) , alone or in combination .


A ninth placebo-controlled study calculated effect sizes .


Minimal important differences ( MID ) were determined using anchor-based methods from two trials and by interviewing @ patients .


Patient interviews supported content validity for the ASRMU diary .


Test-retest reliability was acceptable for SFD ( ICC :@ -@ ) , but varied for RFD ( ICC :@ -@ ) .


Paper-and-pencil and eDiary modes of administration were equivalent ( SFD , ICC = @ ; RFD , ICC = @ ) .


ICS/LABA had the largest percentage of SFD and RFD , followed by monotherapy and then placebo .


MIDs were @-@ @ % for SFD and @-@ @ % for RFD .


The ASRMU diary captures the disease-specific concepts of greatest importance to asthma patients and provides important information for asthma diagnosis and treatment evaluation .


To evaluate the effect of microecologic treatment combined enteral nutrition on serum endotoxin , tumor necrosis factor - ( TNF - ) , interleukin-@ ( IL-@ ) , blood ammonia levels and nutritional status in patients with hepatic encephalopathy .


@ patients with hepatic encephalopathy were allocted randomly into @ groups , on the basis of conventional liver protective therapy and uragogue with one group given probiotics plus enteral nutrition , one given probiotics only , and the @rd group given intravenous nutrition .


The whole course of treatment was four weeks .


Serum levels of endotoxin , TNF - , IL-@ , ammonia and albumin were determined before and on the @th and @th day after treatment .


The levels of serum endotoxin , TNF - , IL-@ and blood ammonia in the combined treatment group decreased remarkably after treatment , while the level of serum albumin elevated markedly .


The difference was significant at statistics as compared with the only probiotics group and intravenous nutrition group ( P < @ ) .


Microecologic treatment combined enteral nutrition could effectively reduce blood ammonia and serum endotoxin levels , protect intestinal mucosal barrier , as well as improve nutritional status of patients with hepatic encephalopathy , which was considered as a safe and efficient therapy .


The aim of this study was to determine if the timing of intra-articular local anesthetic injection and the status of the suction drain affect variable pain scores after ACL reconstruction .


The study included @ patients undergoing arthroscopic ACL reconstruction randomized into @ groups .


Patients in Group @ received intra-articular @ ml of @ % bupivacaine @ minutes before the start of the operation ( preemptive : PE ) , Group @ at the end of the operation with the suction drain opened ( DO ) .


Group @ also received intra-articular bupivacaine at the end of the operation and the drain was kept closed for one hour postoperatively ( DC ) .


Group @ did not receive any intra-articular injection ( control group : CG ) and served as the control group .


Visual analog scale ( VAS ) scores and additional analgesic requirements were recorded .


The PE group had the lowest and the control group the highest VAS scores at the second postoperative hour .


At the fourth postoperative hour , VAS scores were significantly higher in the DC group than the DO group ( p < @ ) .


At the sixth postoperative hour , the PE and DC groups had significantly lower VAS scores than the other groups ( p < @ ) .


At Hour @ , the PE and control groups had higher VAS scores than the DO and DC groups .


VAS scores were not different among groups at Hour @ .


The interval to first analgesic requirement was significantly shorter in the control group and longer in the PE group in comparison to the other two groups ( p < @ ) .


Intra-articular bupivacaine injection at different stages of the operation yielded variable VAS scores in the postoperative period .


Closing the drain after intra-articular injection resulted in an early onset analgesic effect without shortening the duration .


To investigate the prevention of diarrhea by oral BIFICO for infants aged @-@ years .


@ cases of infants were randomly divided after age stratification : the experimental group ( n = @ ) and the control group ( n = @ ) .


Based on principles of randomized double-blind and placebo-controlled , the infants were given BIFICO ( dedicated clinical research ) therapy for @ consecutive days , then observed for @ days .


@ days composed a cycle .


They were observed total @ cycles .


During the study period , principles for `` the diarrhoea patients must be detected '' , follow-up visited the participant infants and conducted etiology detection by way of sampling for diarrhea infants .


Evaluate the prevention efficacy of diarrhea by oral BIFICO for infants aged @-@ years .


A total of @ completed all study .


@ and @ infants in the control group and experimental group were detected with diarrhea .


The incidence of diarrhea was @ % and @ % in these two guoup , respectively .


The difference has statistical significance ( chi@ = @ , P = @ ) .


In the third observation period , the infants in the control group had a higer incidence of diarrhea compared with which in the experimental group ( chi@ = @ , P = @ ) .


@ strains of rotavirus , @ strains of norovirus , @ strains of sappovirus , @ strains of adenovirus , @ strains of salmonella and @ strains of Shigella were check out in @ samples .


Oral BIFICO can paly certain preventive role on diarrhea , and decrease the incidence of diarrhea in infants aged @-@ years .


To evaluate whether electroacupuncture ( EA ) at ST@ can accelerate the recovery of gastrointestinal motility after colorectal surgery .


Forty patients of American Society of Anesthesiologists physical status II and III undergoing elective open resection of malignant colorectal tumours were included in this study .


Using a sealed envelope method , the patients were randomly divided into two groups either receiving EA ( EA group ) or sham EA ( SEA group ) .


Data regarding the recovery of bowel function ( times to the first bowel sounds , passage of flatus and defaecation ) were collected and analysed .


In the EA group , the time intervals from surgery to the first bowel movement and passage of flatus were shorter than in the SEA group ( @h vs @h , p < @ and @h vs @h , p < @ , respectively ) .


There was no significant difference between the groups regarding the time to first defaecation ( @h vs @h , p > @ ) .


EA at ST@ accelerates the recovery of gastrointestinal motility after colorectal surgery .


Medication non-adherence is considered an important cause of morbidity and mortality in primary care .


This study aims to determine the effectiveness , cost effectiveness and acceptability of a complex intervention delivered by community pharmacists , the New Medicine Service ( NMS ) , compared with current practice in reducing non-adherence to , and problems with , newly prescribed medicines for chronic conditions .


Research subject group : patients aged @ years and above presenting in a community pharmacy for a newly prescribed medicine for asthma/chronic obstructive pulmonary disease ( COPD ) ; hypertension ; type @ diabetes or anticoagulant/antiplatelet agents in two geographical regions in England .


parallel group patient-level pragmatic randomized controlled trial .


patients randomized to either : ( i ) current practice ; or ( ii ) NMS intervention comprising pharmacist-delivered support for a newly prescribed medicine .


proportion of adherent patients at six , ten and @ weeks from the date of presenting their prescriptions at the pharmacy ; cost effectiveness of the intervention versus current practice at @ weeks and @ weeks ; in-depth qualitative understanding of the operationalization of NMS in pharmacies .


impact of NMS on : patients ' understanding of their medicines , pharmacovigilance , interprofessional and patient-professional relationships and experiences of service users and stakeholders.Economic analysis : Trial-based economic analysis ( cost per extra adherent patient ) and long-term modeling of costs and health effects ( cost per quality-adjusted-life-year ) will be conducted from the perspective of National Health Service ( NHS ) England , comparing NMS with current practice.Qualitative analysis : a qualitative study of NMS implementation in different community settings , how organizational influences affect NMS delivery , patterns of NMS consultations and experiences of professionals and patients participating in NMS , and patients receiving current practice .


@ patients in each treatment arm would provide at least @ % power ( two-tailed alpha of @ ) to demonstrate a reduction in patient-reported non-adherence from @ % to @ % in the NMS arm compared with current practice , assuming a @ % drop-out rate .


At the time of submission of this article , @ community pharmacies have been recruited and the interventions are being delivered .


Analysis has not yet been undertaken .


To observe the clinical efficacy difference in the treatment of neonatal hypoxic ischemic encephalopathy ( NHIE ) between the combined therapy of acupuncture land acupoint injection of nerve growth fac-tor ( NGF ) and the combined therapy of the intravenous drop of citicoline sodium and intramuscular injection of NGF .


Sixty-one cases of NHIE were randomized into an observation group ( @ cases ) and a control group ( @ cases ) .


In the observation group , acupuncture combined with acupint injection of NGF was adopted .


The acupoints were Baihui ( GV @ ) , Dazhui ( GV @ ) and Fengfu ( GV @ ) , @ mL each acupoint , once a day .


In the control group , the intravenous drop of citicoline sodium and intramuscular injection of NGF were used .


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


Separately , in @ , @ and @ days of treatment , the clinical efficacy , behavior nerve determination score and adverse reaction were observed in the two groups .


In @ , @ and @ days of treatment , the total effective rates were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) in the observation group and were @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) in the control group .


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


The behavior determination scores in @ , @ and @ days were all improved obviously as compared with those before treatment in the two groups ( P < @ , P < @ ) .


The score in the control group was better than that in the , observation group in the @ days ( P < @ ) .


The differences were not significant in the scores between the two groups in @ and @ days ( both P > @ ) .


The incidence of adverse reaction in the observation group was lower than that in , the control group -LSB- @ % ( @/@ ) vs @ % ( @/@ ) , P < @ -RSB- and the severity was mild .


In the treatment of NHIE with the combined therapy of acupuncture and acupint injection , the overall efficacy in @ week ; is inferior to that of the combined therapy of the intravenous drop of citicoline sodium and intramuscular injection of NGF .


But the efficacy is improved gradually along with the treatment progression and the adverse reaction is less .


Eventual control of HIV/AIDS is believed to be ultimately dependent on a safe , effective and affordable vaccine .


Participation of sub-Saharan Africa in the conduct of HIV trials is crucial as this region still experiences high HIV incidences .


We describe the experience of recruiting and retaining volunteers in the first HIV vaccine trial ( HIVIS@ ) in Tanzania .


In this trial enrolled volunteers from amongst Police Officers ( POs ) in Dar es Salaam were primed with HIV-@ DNA vaccine at months @ , @ and @ ; and boosted with HIV-@ MVA vaccine at months @ and @ .


A stepwise education provision/sensitization approach was employed to eventual recruitment .


Having identified a `` core '' group of POs keen on HIV prevention activities , those interested to participate in the vaccine trial were invited for a first screening session that comprised of provision of detailed study information and medical evaluation .


In the second screening session results of the initial assessment were provided and those eligible were assessed for willingness to participate ( WTP ) .


Those willing were consented and eventually randomized into the trial having met the eligibility criteria .


Voluntary participation was emphasized throughout .


Out of @ POs who formed the core group , @ ( @ % ) attended the educational sessions .


@ out of @ ( @ % ) indicated willingness to participate in the HIV vaccine trial .


@ % of those indicating WTP attended the pre-screening workshops .


@ ( @ % ) indicated willingness to undergo first screening and @ POs attended for initial screenings , of whom @ ( @ % ) underwent both clinical and laboratory screenings .


@ volunteers ( @ % ) were eligible for the study .


@ were randomized into the trial , while @ did not turn up , the major reason being partner/family advice .


@ volunteers including @ females were recruited during a one-year period .


All participated in the planned progress updates workshops .


Retention into the schedule was : @ % for the @ DNA/placebo vaccinations , while it was @ % and @ % for the first and second MVA/placebo vaccinations respectively .


In this first HIV vaccine trial in Tanzania , we successfully recruited the volunteers and there was no significant loss to follow up .


Close contact and updates on study progress facilitated the observed retention rates .


The GeparQuinto study showed that adding bevacizumab to @ weeks of anthracycline-taxane-based neoadjuvant chemotherapy increases pathological complete response ( pCR ) rates overall and specifically in patients with triple-negative breast cancer ( TNBC ) .


No difference in pCR rate was observed for adding everolimus to paclitaxel in nonearly responding patients .


Here , we present disease-free ( DFS ) and overall survival ( OS ) analyses .


Patients ( n = @ ) with HER@-negative tumors of a median tumor size of @ cm were randomly assigned to neoadjuvant treatment with epirubicin/cyclophosphamide followed by docetaxel ( EC-T ) with or without eight infusions of bevacizumab every @ weeks before surgery .


Patients without clinical response to EC Bevacizumab were randomized to @ weekly cycles paclitaxel with or without everolimus @ mg/day .


To detect a hazard ratio ( HR ) of @ ( = @ , = @ ) @ events had to be observed in the bevacizumab arms .


With a median follow-up of @ years , @-year DFS was @ % and @-year OS was @ % .


Outcome was not different for patients receiving bevacizumab ( HR @ ; P = @ for DFS and HR @ ; P = @ for OS ) compared with patients receiving chemotherapy alone .


Patients with TNBC similarly showed no improvement in DFS ( HR = @ ; P = @ ) and OS ( HR = @ ; P = @ ) when treated with bevacizumab .


No other predefined subgroup ( HR + / HER@ - ; locally advanced ( cT@ or cN@ ) or not ; cT@-@ or cT@ ; pCR or not ) showed a significant benefit .


No difference in DFS ( HR @ ; P = @ ) and OS ( HR @ ; P = @ ) was observed for nonearly responding patients receiving paclitaxel with or without everolimus overall as well as in subgroups .


Long-term results , in opposite to the results of pCR , do not support the neoadjuvant use of bevacizumab in addition to an anthracycline-taxane-based chemotherapy or everolimus in addition to paclitaxel for nonearly responding patients .


It is still inconclusive whether chronic hepatitis B ( CHB ) patients with persistently normal alanine aminotransferase ( PNALT ) should receive nucleoside/nucleotide analogues .


This study is to evaluate the efficacy of entecavir in improving liver histology in CHB patients with PNALT .


In this prospective randomized , double-blind , placebo-controlled study , @ CHB patients with PNALT were screened , @ patients received biopsy and @ patients met the HBV DNA and histology criteria and were randomly assigned to either an entecavir or placebo group for @ weeks , with @ and @ in each group , respectively .


The primary objective was to evaluate histological improvement .


The secondary objective is to evaluate virological efficacy .


A total of eight ( @ % ) patients in the entecavir group and eight ( @ % ) in the placebo group ( P = @ ) showed histological improvement .


The decrease in total Knodell scores ( sd ) was @ @ in the entecavir group and @ @ in the placebo group ( P = @ ) .


The subjects with undetectable HBV DNA at week @ were @/@ ( @ % ) in the entecavir group and @/@ ( @ % ) in the placebo group ( P < @ ) .


The mean HBV DNA reduction from baseline to week @ was @ @ in the entecavir and @ @ in the placebo group ( P < @ ) .


CHB patients with PNALT receiving entecavir therapy for one year achieved virological efficacy , but not histological benefit .


ClinicalTrials.gov number NCT@ .


The aims of this study were to evaluate correlates and predictors of life functioning and quality of life in bipolar disorder during a comparative effectiveness trial of moderate doses of lithium .


In the Lithium treatment moderate-dose use study ( LiTMUS ) , @ symptomatic outpatients with bipolar disorder type I or II were randomized to receive lithium plus `` optimal personalized treatment ( OPT ) '' , or OPT alone .


Participants were assessed using structured diagnostic interviews , clinician-rated blinded assessments , and questionnaires .


We employ linear mixed effects models to test the effect of treatment overall and adjunct lithium specifically on quality of life or functioning .


Similar models are used to examine the association of baseline demographics and clinical features with quality of life and life functioning .


Quality of life and impaired functioning at baseline were associated with lower income , higher depressive severity , and more psychiatric comorbid conditions .


Over @ months , patients in both treatment groups improved in quality of life and life functioning ( p-Values < @ ) ; without a statistically significant difference between the two treatment groups ( p-Values > @ ) .


Within the lithium group , improvement in quality of life and functioning was not associated with concurrent lithium levels at week @ or week @ ( p-Values > @ ) .


Lower baseline depressive severity and younger age of onset predicted less improvement in functioning over @ months .


Optimized care for bipolar disorder improves overall quality of life and life functioning , with no additional benefit from adjunct moderate doses of lithium .


Illness burden and psychosocial stressors were associated with worse quality of life and lower functioning in individuals with bipolar disorder .


To assess the accuracy of guided surgery ( mucosa and bone-supported ) compared to mental navigation or the use of a surgical template , in fully edentulous jaws , in a randomized controlled study .


Fifty-nine patients ( @ jaws ) , requiring four to six implants ( maxilla or mandible ) , were consecutively recruited and randomly assigned to one of the following treatment groups ; guidance via Materialise Universal ( ) / mucosa , Materialise Universal ( ) / bone , Facilitate/mucosa , Facilitate/bone , or mental navigation or a pilot-drill template .


The precision was assessed by matching the planning computed tomography ( CT ) with a post-operative cone beam CT. .


A significant lower mean deviation at the entry point ( @ mm , range : @-@ @ ) , at the apex ( @ mm , range : @-@ @ ) and angular deviation ( @ , range : @-@ ) was observed for the guiding systems when compared to mental navigation ( @ mm , range : @-@ @ ; @ mm , range : @-@ @ and @ , range : @-@ @ ) and to the surgical template group ( @ mm , range : @-@ @ ; @ mm , range : @-@ @ and @ , range : @-@ @ ) .


Differences between bone and mucosa support or type of guidance were negligible .


Jaw and implant location ( posterior-anterior , left-right ) , however , had a significant influence on the accuracy when guided .


Based on these findings , guided implant placement appears to offer clear accuracy benefits .


In this study , the impact of quetiapine fumarate extended release ( QXR ) and escitalopram ( ESC ) on HPA axis activity was investigated in depressed patients in relationship to antidepressant efficacy .


In a randomized , open-label @-week trial @ inpatients suffering from major depression ( DSM-IV criteria ) were treated for @ weeks with either QXR ( @ mg/day ) or ESC ( @mg/day ) .


The dexamethasone/CRH ( DEX/CRH ) test was performed before treatment , after @ , and after @ weeks of treatment .


Cortisol ( COR ) AUC values were used to assess HPA axis function .


The Hamilton Depression Rating Scale was used weekly to estimate antidepressant efficacy .


QXR and ESC showed comparable antidepressant effects but strongly differed in their impact on HPA axis activity .


In the QXR group , a marked inhibition of COR AUC levels was observed which was most pronounced after one week of treatment but showed a partial re-increase after @ weeks of treatment .


In contrast , ESC transiently stimulated COR AUC values ( week @ ) whereas COR AUC levels at week @ and week @ were comparable .


COR improvement at week @ ( defined as COR peak value reduction between DEX/CRH test @ and @ ) was significantly associated with better clinical outcome .


Apparently , different effects on HPA axis activity reflect distinct pharmacoendocrinological properties of psychotropic drugs .


Several studies indicate that increasing the alimentary limb length in gastric bypass surgery produces only a minor improvement of excess BMI loss .


Few studies have addressed the efficacy of increasing the length of the pancreatico-biliary limb .


Here , we present a prospective randomized study of @ consecutive laparoscopic Roux-Y gastric bypass operations operated over @ years ( @-@ ) in Iceland .


The patients were operated with a gastric bypass with either a @-m biliopancreatic ( BP ) - limb and a @-cm alimentary ( A ) - limb ( n = @ ) or with a @-cm A-limb and a @-cm BP-limb ( n = @ ) .


Preoperative median BMI was @ ( @-@ ) , median age @ ( @-@ ) years , and @ % of the patients were female .


Follow-up rate after @ years was @ % .


Eighteen months following surgery , the weight loss was significantly higher in the BP-limb group ( p < @ ) , and this difference remained @ years after surgery .


Weight regain occurred in both groups , and @ years after surgery , excess BMI loss ( EBMIL ) was @ % in the BP-limb group compared to @ % in the A-limb group ( p < @ ) .


Most patients ( @ % ) needed supplementation adjustment ( iron , vitamin D and calcium ) during the study period , significantly more often in the BP-limb group compared to the A-limb group ( p < @ ) .


Patients in the BP-limb group had more frequent stools than patients in the A-limb group ; otherwise , gastro-intestinal symptoms rating scoring were comparable .


Complication rate was similar .


Gastric bypass with a @-m BP-limb gives better weight loss than gastric bypass with a @-cm BP-limb and a @-cm A-limb .


Metabolic follow-up is of utmost importance , as most patients needed repeated adjustments of their supplementation .


The Diabetes Prevention Program ( DPP ) is highly effective in promoting weight loss in overweight and obese individuals .


However , one-on-one DPP sessions are costly .


As a cost-saving alternative , a group version of the DPP , called Group Lifestyle Balance program ( GLB ) , has been developed but has been shown to be less effective .


The aim of this two-arm parallel randomized controlled trial is to increase the effectiveness of the GLB by integrating habit formation techniques , namely if-then plans and their mental practice , into the program .


A total of @ participants will be randomized to a standard or enriched GLB program .


For the enriched GLB program , if-then plans and their mental practice will be integrated into the standard GLB program .


Participants will be overweight or obese men and women ( BMI of @ to @kg/m@ , waist circumference@ for women , @ for men , @ to @years of age ) who do less than @minutes of self-reported moderate or vigorous exercise per week .


Measures will be completed at baseline , @months , post-intervention ( @months ) , and @months post-intervention ( @months ) .


The primary outcome measure is weight loss at @ , @ , and @months .


Secondary outcomes include percent reaching weight loss goal , physical activity at @ , @ , and @months , and weight-related risk factors ( waist circumference , hemoglobin A@c , systolic/diastolic blood pressure , total cholesterol/HDL ratio ) .


Standardized training of the life-style coaches , use of standardized manuals , and audio taping and reviewing of the sessions will ensure intervention fidelity .


The study will provide evidence-based data on the effectiveness of an enhanced GLB intervention in promoting weight loss and in reducing weight-related risk factors for chronic health problems .


Ethical clearance has been received from the Research Ethics and Compliance Board of the Faculty of Medicine Research and Graduate Studies Office at McGill University ( Montreal , Canada ) .


Endogenous pain modulation ( EPM ) is central to the processing of sensory information .


Visceral and somatic EPM are abnormal in irritable bowel syndrome , but have not been studied in functional dyspepsia ( FD ) .


Visceral EPM was assessed in @ FD patients and @ healthy controls .


Gastric pain was induced with oral capsaicin and EPM was studied by adding heterotopic thermal foot stimulation or distraction by STROOP test .


Somatic EPM was assessed using foot heat stimulation with heterotopic hand electrical stimulation .


Endogenous pain modulation by distraction reduced mean gastric pain by @ on the @-@ visual analog scale ( @ % CI : @-@ @ ) in controls ( p = @ ) and by @ ( -@ to @ ) in FD ( p = @ ) , with greater EPM in controls than in FD ( difference -@ -LSB- -@ to -@ -RSB- ; p = @ ) .


Endogenous pain modulation by heterotopic foot stimulation reduced gastric pain by @ ( -@ to @ ) in controls ( p = @ ) and by @ ( -@ to @ ) in FD ( p = @ ) , with no significant difference in EPM between controls and FD ( -@ -LSB- -@ to @ -RSB- ; p = @ ) .


In patients with prominent FD pain , greater pain correlated with decreased visceral EPM by distraction ( r = @ , p = @ ) .


Somatic EPM by heterotopic stimulation significantly decreased foot pain in controls ( p = @ ) , but not in FD ( p = @ ) .


In FD , visceral pain modulation by distraction was dysfunctional compared to controls .


Somatic pain modulation was also decreased in FD .


These data and the correlation of abnormal pain modulation by distraction with clinical pain in pain-predominant FD suggest a potential pathophysiological significance of abnormal pain modulation in FD .


To investigate the effect of an early childhood obesity prevention intervention , incorporating a parent modelling component , on fathers ' obesity risk-related behaviours .


Cluster randomized-controlled trial in the setting of pre-existing first-time parents groups organised by Maternal and Child Health Nurses in Victoria , Australia .


Participants were @ first-time fathers mean age = @ ( s.d. @ ) years .


Dietary pattern scores of fathers were derived using principal component analysis , total physical activity and total television viewing time were assessed at baseline ( infant aged three to four months ) and after @ months .


No significant beneficial intervention effect was observed on fathers ' dietary pattern scores , total physical activity or total television viewing time .


Despite a strong focus on parent modelling ( targeting parents own diet , physical activity and television viewing behaviours ) , and beneficial impact on mothers ' obesity risk behaviours , this intervention , with mothers as the point of contact , had no effect on fathers ' obesity risk-related behaviours .


Based on the established links between children 's obesity risk-related behaviors and that of their fathers , a need exists for research testing the effectiveness of interventions with a stronger engagement of fathers .


The time course of the contingent negative variation ( CNV ) as well as beta-power are known to entrain to regular task rhythms , revealing implicit anticipatory timing .


Thus far , these effects have been established for manual responses only .


Here we investigate entrainment preceding leg movements .


High-density EEG was recorded while participants were standing and responded to series of rhythmically presented arrow stimuli by making brisk leg movements .


The standard interval between reaction stimuli differed between series and was either @ or @ ms. Each series ' final interval was @ ms , representing a timing perturbation .


Entrainment was manifested in the CNV time course , where the maximum amplitude was reached just before the next stimulus was presented .


The pattern of beta - ( de ) synchronization similarly entrained to the task rhythm .


CNV scalp topographies suggested effector dependency of the entrainment-induced CNV .


We demonstrate that lower limb motor control , like upper limb control , readily entrains to a regular task rhythm .


These findings are relevant to Parkinson 's disease ( PD ) , where problems are found in rhythm processing and temporal preparation .


Investigation of the neural correlates of leg movement entrainment is important in view of presumed relations between entrainment and cueing of gait in PD .


Mixed cryoglobulinaemia is strongly related to hepatitis C virus infection .


Treatment with peg-interferon and ribavirin has been indicated as first-line therapy for mild/moderate hepatitis C virus-related mixed cryoglobulinaemia .


To evaluate the safety and efficacy of triple boceprevir-based antiviral therapy in patients with or without mixed cryoglobulinaemia previously treated with peg-interferon and ribavirin , and with advanced liver disease .


Thirty-five hepatitis C virus-positive patients ( @ with asymptomatic mixed cryoglobulinaemia , @ with symptomatic mixed cryoglobulinaemia , and @ without mixed cryoglobulinaemia ) were treated with triple boceprevir-based antiviral therapy .


In @/@ cryoglobulinaemic subjects ( @ % ) , the addition of boceprevir induced cryocrit disappearance .


Cryocrit behaviour was related to virological response , with improvement of symptoms upon undetectable viraemia and reappearance after virological breakthrough .


The rate of sustained virological response was lower in cryoglobulinaemic patients than in patients without mixed cryoglobulinaemia ( @ % vs @ % respectively , p = @ ) .


Boceprevir-based therapy was safe and effective in cryoglobulinaemic patients .


The correlation between direct inhibition of hepatitis C virus replication and clinical improvement in mixed cryoglobulinaemic patients is definitive proof of the key pathogenetic role played by viral replication .


Further studies are needed to confirm and clarify the reduced virological response in patients with mixed cryoglobulinaemia .


Bivalirudin has emerged as a meaningful alternative to heparin in patients undergoing percutaneous coronary intervention ( PCI ) .


To date , it is unclear whether bivalirudin has advantages in patients undergoing rotational atherectomy ( RA ) .


The current subgroup analysis of the ROTAXUS trial compared patients receiving bivalirudin ( n = @ ) to those receiving unfractionated heparin ( UFH ) ( n = @ ) .


Efficacy was assessed by the frequency of periprocedural myocardial infarction ( MI ) and safety by the frequency of major access-site bleeding ( ASB ) .


Baseline characteristics were similar .


Periprocedural MI occurred less frequently in the bivalirudin group ( @ % vs. @ % , p = @ ) , while ASB did not differ significantly ( @ % vs. @ % , p = @ ) .


This effect was larger in the RA group , where bivalirudin significantly reduced periprocedural MI ( @ % vs. @ % , p = @ ) with a trend towards reduced major ASB ( @ % vs. @ % , p = @ ) .


In the control group without RA , bivalirudin was not superior to UFH regarding periprocedural MI ( @ % vs. @ % , p = @ ) and major ASB ( @ % vs. @ % , p = @ ) .


This analysis suggests a differential benefit of bivalirudin in patients treated with RA .


Patients receiving bivalirudin during RA showed significantly less periprocedural MI and fewer ASB compared to patients treated with UFH .


Little is known on the long-term effects of obesity intervention programs in preschool-aged children .


We compared the long-term effects of a multidisciplinary treatment program with a usual-care program in seventy-five @ - to @-year-old overweight or obese children who had participated in a randomized controlled clinical trial .


A follow-up study collecting data at @ and @ months after starting both programs .


The multidisciplinary program consisted of diet counseling , exercise sessions teaching motor skills and focusing on an active lifestyle , and psychoeducation for parents .


Outcome measures were changes in anthropometry and body composition , determined by bioelectrical impedance analysis and ultrasound .


At the end of the @-week treatment program , the multidisciplinary intervention showed a greater decrease in body mass index z score ( BMI-z ) ( mean ( SD ) @ ( @ ) ) and waist circumference z score ( WC-z ) ( mean ( SD ) @ ( @ ) ) , than usual-care .


During the @-month follow-up , a significant overall treatment effect of the multidisciplinary intervention program was demonstrated on BMI-z ( @ , @ % CI @-@ @ ) and abdominal subcutaneous fat ( SCF ) ( @ , @ % CI @-@ @ ) , compared with the usual-care program .


A multidisciplinary intervention program in @ - to @-year-old overweight and obese children shows greater long-term effects on reductions in BMI-z and SCF , compared with a usual-care program .


Severe neonatal jaundice and its progression to kernicterus is a leading cause of death and disability among newborns in poorly-resourced countries , particularly in sub-Saharan Africa .


The standard treatment for jaundice using conventional phototherapy ( CPT ) with electric artificial blue light sources is often hampered by the lack of ( functional ) CPT devices due either to financial constraints or erratic electrical power .


In an attempt to make phototherapy ( PT ) more readily available for the treatment of pathologic jaundice in underserved tropical regions , we set out to test the hypothesis that filtered sunlight phototherapy ( FS-PT ) , in which potentially harmful ultraviolet and infrared rays are appropriately screened , will be as efficacious as CPT .


This prospective , non-blinded randomized controlled non-inferiority trial seeks to enroll infants with elevated total serum/plasma bilirubin ( TSB , defined as @ mg/dl below the level recommended by the American Academy of Pediatrics for high-risk infants requiring PT ) who will be randomly and equally assigned to receive FS-PT or CPT for a total of @ days at an inner-city maternity hospital in Lagos , Nigeria .


Two FS-PT canopies with pre-tested films will be used .


One canopy with a film that transmits roughly @ % blue light ( wavelength range : @ to @ nm ) will be used during sunny periods of a day .


Another canopy with a film that transmits about @ % blue light will be used during overcast periods of the day .


The infants will be moved from one canopy to the other as needed during the day with the goal of keeping the blue light irradiance level above @ W/cm/nm .


FS-PT will be as efficacious as CPT in reducing the rate of rise in bilirubin levels .


Secondary outcome : The number of infants requiring exchange transfusion under FS-PT will not be more than those under CPT .


This novel study offers the prospect of an effective treatment for infants at risk of severe neonatal jaundice and avoidable exchange transfusion in poorly-resourced settings without access to ( reliable ) CPT in the tropics .


Preclinical studies suggest that lithium carbonate ( lithium ) can reduce precipitated cannabinoid withdrawal in rats by stimulating release of the neuropeptide oxytocin , while two open-label studies indicate lithium may ameliorate cannabis withdrawal symptoms in humans .


This study was conducted to examine the efficacy and safety of lithium in the inpatient management of cannabis withdrawal and to determine whether lithium affects plasma oxytocin and the rate of elimination of plasma cannabinoids during abstinence .


Treatment-seeking cannabis-dependent adults ( n = @ ) were admitted for @days to an inpatient withdrawal unit and randomized to either oral lithium ( @mg ) or placebo given twice a day under double-blind randomized controlled trial ( RCT ) conditions .


Primary outcomes included withdrawal severity -LSB- cannabis withdrawal scale ( CWS ) -RSB- , rates of detoxification completion , and adverse events .


Plasma cannabinoids , plasma oxytocin and serum lithium levels were measured repeatedly over admission .


Follow-up research interviews were conducted at @ , @ , and @days postdischarge .


Lithium did not significantly affect total CWS scores relative to placebo , although it significantly reduced individual symptoms of `` loss of appetite , '' `` stomach aches , '' and `` nightmares/strange dreams . ''


No significant group differences were found in treatment retention or adverse events .


Lithium did not increase plasma oxytocin levels nor influence the rate of elimination of cannabinoids .


Both placebo - and lithium-treated participants showed reduced levels of cannabis use ( verified by urinalysis ) and improved health and psychosocial outcomes at @ - and @-day follow-up relative to pretreatment baselines .


Despite the strong rationale for the present study , the efficacy of lithium over placebo in the management of cannabis withdrawal was not demonstrated .


While vitamin D supplementation and exercise are recommended for prevention of falls for older people , results regarding these @ factors are contradictory .


To determine the effectiveness of targeted exercise training and vitamin D supplementation in reducing falls and injurious falls among older women .


A @-year randomized , double-blind , placebo-controlled vitamin D and open exercise trial conducted between April @ and March @ in Tampere , Finland .


Participants were @ home-dwelling women @ to @ years old .


The main inclusion criteria were at least @ fall during the previous year , no use of vitamin D supplements , and no contraindication to exercise .


Four study groups , including placebo without exercise , vitamin D ( @ IU/d ) without exercise , placebo and exercise , and vitamin D ( @ IU/d ) and exercise .


The primary outcome was monthly reported falls .


Injurious falls and the number of fallers and injured fallers were reported as secondary outcomes .


In addition , bone density , physical functioning ( muscle strength , balance , and mobility ) , and vitamin D metabolism were assessed .


Intent-to-treat analyses showed that neither vitamin D nor exercise reduced falls .


Fall rates per @ person-years were @ , @ , @ , and @ in the placebo without exercise , vitamin D without exercise , placebo and exercise , and vitamin D and exercise study groups , respectively ; however , injurious fall rates were @ , @ , @ , and @ , respectively .


Hazard ratios for injured fallers were significantly lower among exercisers with vitamin D ( @ ; @ % CI , @-@ @ ) and without vitamin D ( @ ; @ % CI , @-@ @ ) .


Vitamin D maintained femoral neck bone mineral density and increased tibial trabecular density slightly .


However , only exercise improved muscle strength and balance .


Vitamin D did not enhance exercise effects on physical functioning .


The rate of injurious falls and injured fallers more than halved with strength and balance training in home-dwelling older women , while neither exercise nor vitamin D affected the rate of falls .


Exercise improved physical functioning .


Future research is needed to determine the role of vitamin D in the enhancement of strength , balance , and mobility .


On-treatment platelet reactivity ( OTR ) is a predictor of clinical outcomes in patients receiving thienopyridine therapy .


To assess whether point-of-care platelet reactivity testing can discriminate between patients who have and have not received a thienopyridine .


This was an analysis of a randomized , multicenter , pharmacodynamic trial .


Subjects with coronary artery disease treated with aspirin were randomly assigned to clopidogrel @mg daily or prasugrel @mg daily for @days .


Platelet reactivity assessment with the VerifyNow P@Y@ test was performed before study drug admistration and @h after the final dose .


Optimal cut-offs for a detectable drug effect were identified by the use of receiver operating characteristic curve analysis .


A total of @ subjects were enrolled and completed the study .


The c-statistic for the identification of a thienopyridine effect was highly significant ( @ , P < @ ) , including for the clopidogrel and prasugrel groups considered separately ( P < @ for both ) .


The optimal cut-off was < @ P@Y@ reaction units ( PRU ) , which provided a sensitivity of @ % and a specificity of @ % .


This cut-off provided a sensitivity of @ % and a specificity of @ % for a clopidogrel effect , and a sensitivity of @ % and specificity of @ % for a prasugrel effect .


OTR of < @PRU is highly specific for exposure to either clopidogrel or prasugrel .


This may be useful in the management of thienoypridine-treated patients who require surgery .


Furthermore , this diagnostic cut-off is similar to levels of OTR that have been associated with ischemic events in thienopyridine-treated patients , supporting the contention that a lack of drug effect is the mechanistic basis for the prognostic relationship between OTR and clinical outcomes .


Rikkunshito , a standardized Japanese herbal medicine , is thought to accelerate gastric emptying and relieve dyspepsia , although no large-scale , randomized , placebo-controlled trials of rikkunshito have been conducted .


This study aimed to determine the efficacy and safety of rikkunshito for treating functional dyspepsia ( FD ) .


FD patients received @ g rikkunshito or placebo three times a day for @ weeks in this multicenter , randomized , placebo-controlled , parallel-group trial .


The primary end point was the proportion of responders at @ weeks after starting test drug , determined by global patient assessment ( GPA ) .


The improvement in four major dyspepsia symptoms severity scale was also evaluated .


In addition , plasma ghrelin levels were investigated before and after treatment .


Two hundred forty-seven patients were randomly assigned .


In the eighth week , the rikkunshito group had more GPA responders ( @ % ) than the placebo ( @ % ) , although this did not reach statistical significance ( p = @ ) .


Epigastric pain was significantly improved ( p = @ ) and postprandial fullness tended to improve ( p = @ ) in the rikkunshito group at week @ .


Rikkunshito was relatively more effective among Helicobacter pylori-infected participants ( rikkunshito : @ % vs placebo : @ % , p = @ ) , and seemed less effective among H. pylori-uninfected participants ( rikkunshito : @ % vs placebo : @ % , p = @ ) .


Among H. pylori-positive individuals , acyl ghrelin levels were improved just in rikkunshito group .


There were no severe adverse events in both groups .


Administration of rikkunshito for @ weeks reduced dyspepsia , particularly symptoms of epigastric pain and postprandial fullness .


( UMIN Clinical Trials Registry , Number UMIN@ ) .


There is debate about benefits of acupuncture for knee pain .


To determine the efficacy of laser and needle acupuncture for chronic knee pain .


Zelen-design clinical trial ( randomization occurred before informed consent ) , in Victoria , Australia ( February @-December @ ) .


Community volunteers ( @ patients aged @ years with chronic knee pain ) were treated by family physician acupuncturists .


No acupuncture ( control group , n = @ ) and needle ( n = @ ) , laser ( n = @ ) , and sham laser ( n = @ ) acupuncture .


Treatments were delivered for @ weeks .


Participants and acupuncturists were blinded to laser and sham laser acupuncture .


Control participants were unaware of the trial .


Primary outcomes were average knee pain ( numeric rating scale , @ -LSB- no pain -RSB- to @ -LSB- worst pain possible -RSB- ; minimal clinically important difference -LSB- MCID -RSB- , @ units ) and physical function ( Western Ontario and McMaster Universities Osteoarthritis Index , @ -LSB- no difficulty -RSB- to @ -LSB- extreme difficulty -RSB- ; MCID , @ units ) at @ weeks .


Secondary outcomes included other pain and function measures , quality of life , global change , and @-year follow-up .


Analyses were by intention-to-treat using multiple imputation for missing outcome data .


At @ weeks and @ year , @ ( @ % ) and @ ( @ % ) participants were lost to follow-up , respectively .


Analyses showed neither needle nor laser acupuncture significantly improved pain ( mean difference ; -@ units ; @ % CI , -@ to @ , and -@ ; @ % CI , -@ to @ , respectively ) or function ( -@ ; @ % CI , -@ to @ , and @ ; @ % CI , -@ to @ , respectively ) compared with sham at @ weeks .


Compared with control , needle and laser acupuncture resulted in modest improvements in pain ( -@ ; @ % CI , -@ to -@ , and -@ ; @ % CI , -@ to -@ , respectively ) at @ weeks , but not at @ year .


Needle acupuncture resulted in modest improvement in function compared with control at @ weeks ( -@ ; @ % CI , -@ to -@ ) but was not significantly different from sham ( -@ ; @ % CI , -@ to @ ) and was not maintained at @ year .


There were no differences for most secondary outcomes and no serious adverse events .


In patients older than @ years with moderate or severe chronic knee pain , neither laser nor needle acupuncture conferred benefit over sham for pain or function .


Our findings do not support acupuncture for these patients .


To compare the reciprocal control of agonist and antagonist muscles in individuals with and without spinocerebellar ataxia ( SCA ) and to evaluate the effect of a @-week leg cycling regimen on functional coordination and reciprocal control of agonist and antagonist muscles in patients with SCA .


Randomized controlled trial with repeated measures .


Research laboratory in a general hospital .


Individuals with SCA ( n = @ ) and without SCA ( n = @ ) .


A single @-minute session of leg cycling and a @-week cycling regimen .


Individuals with SCA ( n = @ ) and without SCA ( n = @ ) underwent disynaptic reciprocal inhibition and D@ inhibition tests of the soleus muscles before and after a single @-minute cycling session .


Individuals with SCA were randomly assigned to either participate in @ weeks of cycling training ( n = @ ) or to receive no training ( n = @ ) .


The disynaptic reciprocal inhibition and D@ inhibition and International Cooperative Ataxia Rating Scale ( ICARS ) scores were evaluated in both groups after @ weeks .


Individuals with SCA showed abnormally strong resting values of disynaptic reciprocal inhibition and D@ inhibition ( P < @ ) and impaired inhibition modulation capacity after a single @-minute session of cycling ( P < @ ) .


The inhibition modulation capacity was restored ( P < @ ) , and the ICARS scores improved significantly ( pre : @ , post : @ ; P = @ ) after @ weeks of cycling training .


A @-week cycling regimen can normalize the modulation of reciprocal inhibition and functional performance in individuals with SCA .


These findings are applicable to the coordination training of patients .


In @ , supported by data from two separate trauma centers , we implemented a protocol to administer tranexamic acid ( TXA ) in trauma patients with evidence of hyperfibrinolysis ( HF ) on admission .


The purpose of this study was to examine whether the use of TXA in patients with HF determined by admission rapid thrombelastography was associated with improved survival .


Following institutional review board approval , we evaluated all trauma patients @ years or older admitted between September @ and September @ .


HF was defined as LY-@ of @ % or greater .


Patients with LY-@ less than @ % were excluded .


Patients were divided into those who received TXA ( TXA group ) and those who did not ( no-TXA group ) .


After univariate analyses , a purposeful , logistic regression model was developed a priori to evaluate the impact of TXA on mortality ( controlling for age , sex , Injury Severity Score ( ISS ) , arrival physiology , and base deficit ) .


A total of @,@ patients met study criteria .


Ninety-eight ( @ % ) received TXA , and @ ( @ % ) did not .


TXA patients were older ( median age , @ years vs. @ years ) , were more severely injured ( median ISS , @ vs. @ ) , had a lower blood pressure ( median systolic blood pressure @ mm Hg vs. @ mm Hg ) , and were more likely to be in shock ( median , base excess , -@ mmol/dL vs. -@ mmol/dL ) , all p < @ .


Twenty-three percent of the patients had a repeat thrombelastography within @ hours ; @ % of the TXA patients had LY-@ of @ % or greater on repeat rapid thrombelastography ( vs. @ % in the no-TXA group , p = @ ) .


Unadjusted in-hospital mortality was higher in the TXA group ( @ % vs. @ % , p < @ ) .


There were no differences in venous thromboembolism ( @ % vs. @ % ) .


Logistic regression failed to find a difference in in-hospital mortality among those receiving TXA ( odds ratio , @ ; @ % confidence interval , @-@ @ ; p @ ) .


In the current study , the use of TXA was not associated with a reduction in mortality .


Further studies are needed to better define who will benefit from an administration of TXA .


Therapeutic study , level IV .


Successful external cephalic version ( ECV ) for breech presenting fetus reduces the need for Caesarean section ( CS ) .


We aimed to compare the success rate of ECV with either spinal anaesthesia ( SA ) or i.v. analgesia using remifentanil .


In a double-phased , stratified randomized blinded controlled study we compared the success rates of ECV , performed under spinal anaesthesia ( SA ) , i.v. analgesia ( IVA ) using remifentanil or no anaesthetic interventions .


In phase I , @ patients were stratified by parity before randomization to ECV , performed by blinded operators , under SA using either hyperbaric bupivacaine @ mg with fentanyl @ g , i.v. remifentanil infusion @ g kg min ( -@ ) , or Control ( no anaesthetic intervention ) .


Operators performing ECV were blinded to the treatment allocation .


In phase @ , patients in the Control group in whom the initial ECV failed were further randomized to receive either SA ( n = @ ) or IVA ( n = @ ) for a re-attempt .


The primary outcome was the incidence of successful ECV .


The success rate in Phase @ was greatest using SA -LSB- @/@ ( @ % ) -RSB- , compared with IVA -LSB- @/@ ( @ % ) -RSB- and Control -LSB- @/@ ( @ % ) -RSB- , ( P = @ ) .


Median -LSB- IQR -RSB- pain scores on a visual analogue scale ( range @-@ ) , were @ -LSB- @-@ -RSB- with SA , @ -LSB- @-@ -RSB- with IVA and @ -LSB- @-@ -RSB- in the Control group ( P < @ ) .


Median -LSB- IQR -RSB- VAS sedation scores were highest with IVA -LSB- @ ( @-@ ) -RSB- , followed by SA , -LSB- @ ( @-@ ) -RSB- and Control -LSB- @ ( @-@ ) -RSB- .


In phase @ , @/@ ( @ % ) of ECV re-attempts were successful with SA , whereas all re-attempts using IVA failed ( P = @ ) .


The incidence of fetal bradycardia necessitating emergency CS within @ min , was similar among groups ; @ % ( @/@ ) in the SA and IVA groups and @ % ( @/@ ) in the Control group .


SA increased the success rate and reduced pain for both primary and re-attempts of ECV , whereas IVA using remifentanil infusion only reduced the pain .


There was no significant increase in the incidence of fetal bradycardia or emergency CS , with ECV performed under anaesthetic interventions .


Relaxation of the abdominal muscles from SA appears to underlie the improved outcomes for ECV .


As the population ages , it is increasingly important to test new models of care that improve life quality and decrease health costs .


This paper presents the rationale and design for a randomized clinical trial of a novel interdisciplinary program to reduce disability among low income older adults based on a previous pilot trial of the same design showing strong effect .


The CAPABLE ( Community Aging in Place , Advancing Better Living for Elders ) trial is a randomized controlled trial in which low income older adults with self-care disability are assigned to one of two groups : an interdisciplinary team of a nurse , occupational therapist , and handyman to address both personal and environmental risk factors for disability based on participants ' functional goals , or an attention control of sedentary activities of choice .


Both groups receive up to @ home visits over @ months .


The primary outcome is decreased disability in self-care ( ADL ) .


Secondary outcomes are sustained decrease in self care disability as well as improvement in instrumental ADLS , strength , balance , walking speed , and health care utilization .


Careful cost tracking and analysis using intervention data and claims data will enable direct measurement of the cost impact of the CAPABLE approach .


CAPABLE has the potential to leverage current health care spending in Medicaid waivers , Accountable Care Organizations and other capitated systems to save the health care system costs as well as improving low income older adults ' ability to age at home with improved life quality .


Our aim was to compare changes of vascular and metabolic parameters in patients with essential hypertension on treatment with combination of perindopril with either indapamide retard or hydrochlorothiazide .


The study involved @ patients who were randomly assigned to perindopril @-@ mg/day in combination with indapamide retard ( P+I ) @ mg/day ( n = @ ) or with hydrochlorothiazide ( P+HT ) @ mg/day ( n = @ ) .


Waist circumference , body mass index , blood lipids and glucose , endothelial function ( EF ) determined as the change of resistance index after inhalation of salbutamol , arterial stiffness measured as mean pulse wave velocity after sublingual trinitroglycerin ( PWVtng ) were evaluated at baseline and @ months thereafter .


Vascular responses were calculated from digital pulse waves registered using photoplethysmography .


Dynamics of BP after @ months did not differ significantly between groups .


Treatment with combination of P+HT resulted in significant decrease of EF ( -@,@ % , p < @,@ ) accompanied by negative changes of triglycerides ( +@,@ % , p < @,@ ) and glucose levels ( +@,@ % , p < @,@ ) , whereas combination of P+I did not affect endothelial function and was metabolically neutral .


PWVtng significantly decreases on both regiments of treatment with the trend in favor of P+I combination ( -@,@ % , p < @,@ versus -@,@ % , p < @,@ for P+I and P+HT combinations , respectively ) .


Thus , despite the similar BP reduction the combination of ACE-inhibitor -- perindopril with indapamide retard possesses more favorable vascular and metabolic effects compared to combination with hydrochlorothiazide that potentially may account for different prognosis of patients with arterial hypertension on long-term treatment .


There is non-experimental evidence that paracetamol ( acetaminophen ) use may increase the risk of developing asthma .


However , numerous methodological issues need to be resolved before undertaking a randomized controlled trial to investigate this hypothesis .


To establish the feasibility of a randomized controlled trial of liberal paracetamol as usually given by parents/guardians vs. a comparator ( restricted paracetamol in accordance with WHO guidelines , ibuprofen or placebo ) , and childhood asthma risk .


Questionnaires were completed by parents/guardians of infants admitted to Wellington Hospital with bronchiolitis to assess views about comparator treatments .


Subsequently , infants of parents/guardians who provided informed consent were randomized to restricted or liberal paracetamol use for @ months with paracetamol use recorded .


Of @ eligible participants , @ ( @ % ) parents/guardians completed the questionnaire .


Ibuprofen , restricted paracetamol and placebo were acceptable to @ ( @ % ) , @ ( @ % ) and @ ( @ % ) parents/guardians , respectively .


@ ( @ % ) infants were randomized to restricted or liberal paracetamol .


Paracetamol use was greater for the liberal vs. restricted group for reported -LSB- Hodges-Lehmann estimator of difference @ mg/kg/day ( @ % CI @-@ @ ) , P = @ -RSB- and measured use -LSB- Hodges-Lehmann estimator of difference @ mg/kg/day ( @ % CI @-@ @ ) , P = @ -RSB- .


The median reported and measured use of paracetamol was @-fold and @-fold greater in the liberal vs. restricted group .


Although separation in paracetamol dosing is likely to be achieved with a liberal vs. restricted paracetamol regime , ibuprofen is the preferred comparator treatment in the proposed RCT of paracetamol use and risk of asthma in childhood .


In cancer research , outcome measures may co-vary .


Treatment and treatment related impairment of health-related quality of life ( HRQoL ) may affect survival .


When these effects are analyzed separately , bias may arise .


Therefore , we investigated the combined effect of treatment and longitudinally measured HRQoL on survival .


Patients with anaplastic oligodendrogliomas ( n = @ ) who were randomized ( EORTC @ ) to radiotherapy ( RT ) alone or RT plus procarbazine , lomustine , and vincristine ( PCV ) chemotherapy were analyzed .


HRQoL -LSB- appetite loss ( AP ) -RSB- was assessed with the EORTC QLQ-C@ .


We compared survival results from different analysis strategies : Cox model with treatment only -LSB- model @ ( M@ ) -RSB- or with treatment and time-dependent AP score -LSB- model @ ( M@ ) -RSB- and the joint model combining longitudinal AP score and survival -LSB- model @ ( M@ ) -RSB- .


The estimated hazard ratio ( HR ) for RT plus PCV was @ ( @ % CI @-@ @ ) for M@ , @ ( @-@ @ ) for M@ , and @ ( @-@ @ ) for M@ .


This corresponds to a lower risk of death of @ % in M@ , @ % in M@ , and @ % in M@ , for patients treated with RT plus PCV chemotherapy .


AP resulted in an increased risk of death , with estimated HR of @ ( @-@ @ ) for M@ and @ ( @-@ @ ) for M@ : Every @-point increase of AP resulted in a @ % increased risk of death in M@ as compared to @ % in M@ .


Part of the survival benefit of treatment with RT plus PCV chemotherapy can be masked by the negative effect that this treatment has on patients ' HRQoL .


In our study , up to @ % of the theoretical treatment efficacy was lost when AP was not adjusted through joint modeling .


Diabetes mellitus is a global epidemic affecting @ million people in the world .


The glycemic control is the key for diabetes prevention and management .


Some proteins can stimulate insulin release and modulate glycemic response .


To assess the effect of the consumption of different types of protein ( whey protein , soy protein and egg white ) on a second meal postprandial glycaemia in normal weight and normoglycemic subjects .


Randomized crossover clinical trial .


After an overnight fast of @-hours , ten subjects attended the laboratory to drink one of the protein shakes ( whey , soy or egg white ) or the control drink .


Thirty minutes later , the subjects consumed a glucose solution ( @ g glucose ) .


Glycemic response was monitored at times @ ( before glucose solution ) and @ , @ , @ , @ , @ and @ min ( after glucose solution consumption ) .


Incremental area under the glycemic curve ( iAUC ) was calculated by the trapezoidal method .


Furthermore , glycemic response was assessed by a new method using iG equation .


Compared with control , whey and soy protein drinks reduced postprandial iAUC in @ % ( p = @ ) and @ % ( p = @ ) , respectively .


Whey protein was the only protein capable of avoiding great fluctuations and a peak in postprandial glycemia .


The assessment of glycemic response by iG equation showed positive correlation with iAUC ( Pearson @ , p < @ ) .


The consumption of whey and soy protein @ minutes before a glucose load resulted in lower iAUC compared with control drink .


Whey protein maintained postprandial glycemia more stable .


To evaluate the efficacy and safety of Yigan Fupi Decoction ( YFD ) in the treatment of irritable bowel syndrome with diarrhea ( IBS-D ) patients .


A randomized controlled clinical trail was carried out in patients with IBS-D .


All patients were randomly assigned to the treatment group ( @ cases , treated with YFD ) and the control group ( @ cases , treated with Pinaverium Bromide Tablet ) .


The treatment course was @ weeks for all patients .


The total effective rate , the stool property and state , the quality of life ( QOL ) , and TCM syndrome efficacy were assessed by IBS bowel symptom severity scale ( IBS-BSS ) , IBS defecation state questionnaire ( IBS-DSQ ) , IBS quality of life questionnaire ( IBS-QOL ) , and traditional Chinese medicine pattern curative effect scoring system ( TCM-PES ) before and after treatment .


There was no statistical difference in the total effective rate between the two groups ( @ % vs. @ % , P > @ ) .


The treatment group was superior in the total IBS-BSS integral to the control group ( P < @ ) .


The total effective rate of improving the stool property was better in the treatment group than in the control group ( @ % vs. @ % , P < @ ) .


Besides , the number of days for emergent defecation among @ days was less in the treatment group than in the control group ( P < @ ) .


The improvement of the total IBS-QOL integral and the total integral of TCM syndrome were better in the treatment group than in the control group ( P < @ ) .


The total effective rate of TCM-PES was better in the treatment group than in the control group ( @ % vs. @ % , P < @ ) .


YFD was effective in the treatment of IBS-D patients of Gan-qi invading Pi syndrome , and could effectively relieve bowel symptoms , improve the stool property and the defecation frequency , elevate their QOL , and attenuate Gan-qi invading Pi syndrome with favorable safety and compliance .


To compare same-day whole-dose vs split-dose of @-litre polyethylene glycol electrolyte lavage solution ( PEG-ELS ) plus bisacodyl for colon cleansing for morning colonoscopy .


Consecutive adult patients undergoing morning colonoscopy were allocated into two groups i.e. , same-day whole-dose or split-dose of @-litre PEG-ELS .


Investigators and endoscopists were blinded to the allocation .


All patients completed a questionnaire that was designed by Aronchick and colleagues to assess the tolerability of the bowel preparation regime used .


In addition , patients answered an ordinal five-value Likert scale question on comfort level during bowel preparation .


Endoscopists graded the quality of bowel preparation using the Boston bowel preparation scale ( BBPS ) .


In addition , endoscopists gave an overall grading of the quality of bowel preparation .


Cecal intubation time , withdrawal time , total colonoscopy time , adenoma detection rate and number of adenomas detected for each patient were recorded .


Sample size was calculated using an online calculator for binary outcome non-inferiority trial .


Analyses was based upon intent-to-treat .


Significance was assumed at P-value < @ .


Data for @ patients were analysed .


Mean age was @ @ years old and consisted of @ % male .


There were @ and @ patients in the split-dose and whole-dose group , respectively .


Split-dose was as good as whole-dose for quality of bowel preparation .


The total BBPS score was as good in the split-dose group compared to the whole-dose group -LSB- @ ( @-@ ) vs @ ( @-@ ) , P = @ -RSB- .


There was no difference in cecal intubation rate , cecal intubation time , withdrawal time , total colonoscopy time and adenoma detection rate .


Median number of adenoma detected was marginally higher in the split-dose group -LSB- @ ( @-@ ) vs @ ( @-@ ) , P = @ -RSB- .


Patients in the whole-dose group had more nausea ( @ % vs @ % , P = @ ) and vomiting ( @ % vs @ % , P = @ ) , and were less likely to complete the bowel preparation ( @ % vs @ % , P = @ ) .


Patients in the split-dose group were less likely to refuse the same bowel preparation regime ( @ % vs @ % , P = @ ) and less likely to want to try another bowel preparation regime ( @ % vs @ % , P < @ ) .


Splitting reduced-volume PEG-ELS for morning colonoscopy is as effective as taking the whole dose on the same morning but is better tolerated and preferred by patients .


The probability of developing osteoporosis decreases with an adequate supply of vitamin D , a balanced diet , and increased physical activity .


In this study , we evaluated whether an educational intervention improves osteoporosis-related behavior in perimenopausal women from rural areas .


A randomized experimental evaluation was performed of an educational intervention .


The variables were physical activity , calcium intake and sun exposure in women from rural areas aged @-@ years ( n = @ ) at time @ and @ months after the educational intervention .


In the control group ( n = @ ) , the information was sent by surface mail ( month @ ) .


In the intervention group ( n = @ ) , two interactive workshops were given ( month @ ) .


The topic of the workshops and the information sent by surface mail was healthy habits for osteoporosis prevention .


After @ months , the intervention group , but not the control group , had increased their physical activity ( p = @ ) , sun exposure ( p = @ ) , and calcium intake ( @ % to @ % ) .


A simple educational intervention in perimenopausal women from rural areas improved healthy habits for osteoporosis prevention .


To investigate the impact of antiangiogenic monotherapy and photodynamic therapy ( PDT ) as add-on strategy on retinal morphology , and to analyse prognostic biomarkers for visual outcome and retreatment frequency in neovascular age-related macular degeneration ( nAMD ) .


@ patients participating in the MONT BLANC study were evaluated .


Patients were randomised to receive as-needed ranibizumab monotherapy or combination therapy ( verteporfin PDT and ranibizumab ) .


Outcome measures included visual acuity ( VA ) , retinal morphology assessed by optical coherence tomography and retreatment frequency .


The proportion of scans showing intraretinal cysts ( IRC ) or subretinal fluid ( SRF ) decreased more intensively in the combination than in the monotherapy group .


Pigment epithelial detachments ( PED ) decreased significantly only in the combination group .


Patients with IRC presented the lowest initial VA , and IRC had the strongest negative predictive value for functional improvement in both groups .


SRF showed a predictive value for a higher number of ranibizumab injections ( combination , +@ ; monotherapy , +@ ) and a higher number of PDT treatments in the combination group ( +@ ) .


PED was associated with a higher number of ranibizumab injections only in the monotherapy group ( +@ ) .


Combination and monotherapy showed a distinct response pattern for morphological parameters in nAMD .


IRC was the only relevant prognostic parameter for functional outcome .


Thyroid hormones are required for normal brain maturation , and neonatal plasma thyroid hormone concentrations are low in infants less than @ weeks gestation .


It is not known whether treatment of such infants with thyroid hormone improves neurodevelopmental outcome .


At three years corrected age , mental , motor , and neurological development was assessed in infants born at less than @ weeks gestational age who had participated in a phase @ trial of differing doses and modes of administration of thyroid hormone .


The trial 's endpoints were thyroid hormone ( thyroxine , T@ ) and thyotropin plasma concentrations in eight study arms : six treated with T@ -LSB- @ , @ , and @ g / ( kg day ) -RSB- , bolus or continuous -RSB- , one treated with iodine only , and one treated with placebo .


Follow-up at three years was not part of the original study goals .


Developmental index scores , rates of cerebral palsy ( CP ) , and rates of adverse outcome ( death or moderate to severe delay in development and/or disabling CP ) were compared between the eight study groups and between groups combined by dosage level , and between infants with and without T@ supplementation .


Of @ randomized infants , @ ( @ % ) died in the neonatal period .


Of the @ survivors , follow-up results were available for @ children ( @ % ) .


Mental and motor development and rates of cerebral palsy did not differ in any of the comparisons made .


In this study , no differences in neurodevelopment were found in relation to thyroid hormone treatment , but power was insufficient to detect any but very large differences .


To compare the effect of intravenous @ % mannitol or dexamethasone ( DM ) on low back and leg pain after minimally invasive transforaminal lumbar interbody fusion ( MI-TLIF ) .


Between October @ and September @ , @ patients with degenerative lumbar diseases underwent MI-TLIF and percutaneous pedicle screw fixation .


All patients were randomly divided into @ groups : @ patients received intravenous @ % mannitol after operation ( mannitol group ) ; @ patients received intravenous DM after operation ( DM group ) ; and @ patients received neither dehydrating agent nor steroid after operation ( control group ) .


There was no significant difference in gender , age , disease duration , clinical symptoms , lesion types , and lesion segments between groups ( P > @ ) .


The serum levels of inflammatory factors -LSB- tumor necrosis factor a ( TNF-alpha ) , interleukin @beta ( IL-@beta ) , and IL-@ -RSB- were measured by ELISA at pre-operation and @ , @ , @ , @ , and @ hours after operation .


Low back and leg pain was determined by using visual analogue scale ( VAS ) score after operation .


All procedures were smoothly performed without major complications of nerve root injury , hematoma , or infection .


There was no significant difference in operation time and intraoperative blood loss between groups ( P > @ ) .


The VAS score of low back pain showed no significant difference between groups at all time points after operation ( P > @ ) ; the VAS score of leg pain in the DM group was significantly lower than that in the control group at all time points ( P < @ ) , and than those in the mannitol group at @ , @ , @ , and @ hours after operation ( P < @ ) .


The serum level of TNF-a in the DM group was significantly lower than that in the control group at all time points ( P < @ ) , and than that in the mannitol group at @ , @ , @ , and @ hours after operation ( P < @ ) .


The serum level of IL-@beta in the DM group was significantly lower than that in the control group at @ , @ , @ , and @ hours after operation ( P < @ ) , and than that in the mannitol group at all time points after operation ( P < @ ) .


The serum level of IL-@ in the DM group was significantly lower than that in the control group at @ and @ hours after operation ( P < @ ) , and than that in the mannitol group at @ , @ , and @ hours after operation ( P < @ ) .


Intravenous @ % mannitol may has no effect on postoperative low back and leg pain , while DM can markedly relieve leg pain after MI-TLIF .


To assess the efficacy of a second-line regimen of oxaliplatin and folinic acid-modulated fluorouracil in patients with advanced pancreatic cancer who have experienced progression while receiving gemcitabine monotherapy .


A randomized , open-label , phase III study was conducted in @ institutions throughout Germany .


Recruitment ran from January @ until May @ , and the last follow-up concluded in December @ .


Overall , @ patients age @ years or older who experienced disease progression during first-line gemcitabine therapy were randomly assigned to folinic acid and fluorouracil ( FF ) or oxaliplatin and FF ( OFF ) .


Patients were stratified according to the presence of metastases , duration of first-line therapy , and Karnofsky performance status .


Median follow-up was @ months , and @ patients were eligible for the primary analysis .


The median overall survival in the OFF group ( @ months ; @ % CI , @ to @ ) versus the FF group ( @ months ; @ % CI , @ to @ ) was significantly improved ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; log-rank P = @ ) .


Time to progression with OFF ( @ months ; @ % CI , @ to @ ) versus FF ( @ months ; @ % CI , @ to @ ) was significantly extended also ( HR , @ ; @ % CI , @ to @ ; log-rank P = @ ) .


Rates of adverse events were similar between treatment arms , with the exception of grades @ to @ neurotoxicity , which were reported in @ patients ( @ % ) and six patients ( @ % ) in the OFF and FF groups , respectively ( P < @ ) .


Second-line OFF significantly extended the duration of overall survival when compared with FF alone in patients with advanced gemcitabine-refractory pancreatic cancer .


Patients receiving hemodialysis often perceive their caregivers are overburdened .


We hypothesize that increasing hemodialysis frequency would result in higher patient perceptions of burden on their unpaid caregivers .


In two separate trials , @ patients were randomized to receive in-center daily hemodialysis ( @ days/week ) or conventional hemodialysis ( @ days/week ) while @ patients were randomized to receive home nocturnal hemodialysis ( @ nights/week ) or home conventional hemodialysis for @ months .


Changes in overall mean scores over time in the @-question Cousineau perceived burden scale were compared .


In total , @ of @ ( @ % ) and @ of @ ( @ % ) randomized patients in the Daily and Nocturnal Trials , respectively , reported having an unpaid caregiver at baseline or during follow-up .


Relative to in-center conventional dialysis , the @-month change in mean perceived burden score with in-center daily hemodialysis was -@ ( @ % confidence interval , -@ to +@ ; P = @ ) .


Relative to home conventional dialysis , the @-month change in mean perceived burden score with home nocturnal dialysis was +@ ( @ % confidence interval , -@ to +@ ; P = @ ) .


After multiple imputation for missing data in the Nocturnal Trial , the relative difference between home nocturnal and home conventional hemodialysis was +@ ( @ % confidence interval , +@ to +@ ; P = @ ) .


In the Nocturnal Trial , changes in perceived burden were inversely correlated with adherence to dialysis treatments ( Pearson r = -@ ; P = @ ) .


Relative to conventional hemodialysis , in-center daily hemodialysis did not result in higher perceptions of caregiver burden .


There was a trend to higher perceived caregiver burden among patients randomized to home nocturnal hemodialysis .


These findings may have implications for the adoption of and adherence to frequent nocturnal hemodialysis .


The first in class angiotensin receptor neprilysin inhibitor , LCZ@ has been shown to reduce levels of N-terminal pro-brain natriuretic peptide ( NT-proBNP ) , reduce left atrial size and improve New York Heart Association ( NYHA ) class in patients with heart failure with preserved ejection fraction ( HFpEF ) .


We examined whether the effects of LCZ@ were independent of systolic blood pressure ( SBP ) lowering .


In the Prospective comparison of ARNi ( angiotensin receptor neprilysin inhibitor ) with ARB ( angiotensin receptor blocker ) on Management Of heart failUre with preserved ejectioN fracTion ( PARAMOUNT ) trial @ patients were randomly assigned to LCZ@ or valsartan .


We examined the relationship between SBP lowering and LCZ@ on NT-proBNP level , left atrial size , NYHA class and estimated glomerular filtration rate ( eGFR ) .


By @weeks blood pressure was reduced by @mmHg ( SD @ ) / @mmHg ( SD @ ) in patients receiving LCZ@ in comparison with @mmHg ( SD @ ) / @mmHg ( SD @ ) in those receiving valsartan .


The change in NT-proBNP was poorly correlated with change in SBP ( LCZ@ , r = @ , P = @ ; valsartan , r = @ , P = @ ) After adjustment for change in SBP , the ratio of change in NT-proBNP at @weeks for LCZ@ vs. valsartan was @ ( @ % CI @-@ @ , P = @ ) , and similar to the ratio not adjusting for SBP ( @ , @ % CI @-@ @ , P = @ ) ; P for interaction was @ ) .


Similarly , reduction in left atrial volume index at @weeks , improvement in NYHA class and eGFR were all independent of the change in SBP .


In patients with HFpEF , the effect of the angiotensin receptor neprilysin inhibitor LCZ@ on NT-proBNP , left atrial volume , functional class , and eGFR was independent of reduction in SBP .


Helping patients control obesity remains a clinical challenge for internists , and African Americans experience obesity rates higher than other racial/ethnic groups .


To investigate whether a behavioral theory-based mobile health intervention would enhance weight loss when added to standard care among overweight/obese African American adults .


A randomized controlled trial of @ adults recruited from Baltimore-area African American churches .


Participant follow-up ended March @ .


Participants were randomized to standard care ( included one-on-one counseling sessions with a dietitian and a physician ) or standard care plus daily tailored text messages for @ months .


Text messages were delivered in phases : preparation , reinforcement of participant-selected diet and exercise goals , reflection , goal integration , weight loss methods , and maintenance .


There were follow-up visits at @ , @ , and @ months .


Primary outcome was weight change from baseline to end-intervention at @ months .


Secondary outcomes included weight change at @ months , engagement , and satisfaction with the intervention .


Sixty-three participants were randomized to the mobile health intervention and @ to standard-care control .


Weights were collected in-window for @ ( @ % ) at @ months and @ ( @ % ) at @ months .


Mean weight loss at @ months was @ kg greater in the intervention group compared with standard care ( @ % confidence interval -LSB- CI -RSB- , -@ to-@ @ ; P < @ ) , and @ kg greater ( @ % CI,-@ @ to-@ @ ; P = @ ) at @ months .


Degree of engagement with messages was correlated with weight loss .


While attrition was high , this study supports a tailored , interactive text-message intervention to enhance weight loss among obese African-American adults .


Severe immobility due to lesions of the brain necessitates therapeutic positioning over the long term .


There is little scientific evidence concerning the efficacy of different positioning methods .


This clinical trial compares the effects of conventional positioning ( CON ) with those of positioning in neutral ( LiN ) .


A prospective , multicenter , investigator-blinded , randomized , controlled trial was performed on a total of @ non-ambulatory patients ( underlying disease : stroke , @ patients ; hypoxic brain damage , @ ; traumatic brain injury , @ ; other , @ ) .


The subjects were randomly assigned to either LiN ( @ patients ) or CON ( @ patients ) and stratified within each of these two positioning concepts to five different positions .


They remained in the assigned positions for two hours .


The primary endpoint was change in the passive range of motion ( PROM ) of the hip joints .


Secondary endpoints were change in the PROM of the shoulder joints and patient comfort .


Patients in the LiN group had a significantly better PROM of the hips after positioning than those in the CON group ( difference , @ ; p < @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) .


The same was true for PROM of shoulder flexion ( @ ; p < @ ; @ % CI , @-@ @ ) and external rotation ( @ ; p < @ ; @ % CI : @-@ @ ) .


@ % of patients in the LiN group reported their comfort level as good , compared to only @ % in the CON group ( p < @ ) .


Positioning severely immobilized patients in LiN for two hours improved passive hip and shoulder mobility and patient comfort compared to conventional positioning .


Further studies are needed to determine whether prolonged LiN positioning might improve rehabilitation and quality of life , prevent pressure sores , or ease nursing care .


To compare the effects of right unilateral ( RUL ) electroconvulsive therapy ( ECT ) and algorithm-based pharmacologic treatment ( APT ) on neurocognitive function in treatment-resistant bipolar disorder depression .


Inpatients with DSM-IV-TR-diagnosed , treatment-resistant bipolar depression , who were acutely admitted to @ of the @ clinical study centers in Norway , were recruited from May @ to April @ into a prospective , randomized controlled , @-week acute treatment trial .


General neurocognitive function was assessed with the MATRICS Consensus Cognitive Battery ( MCCB ) , and retrograde memory for autobiographical events was assessed with the Autobiographical Memory Interview-Short Form ( AMI-SF ) before and shortly after ( mean = @ days ) a trial with either RUL brief-pulse ECT ( mean dose = @ mC ) or APT .


Seventy-three patients entered , and @ ( nECT = @ , nAPT = @ ) completed .


Both groups showed improvements in all MCCB domain scores , with no significant differences between the study groups ( no interaction effect : F , = @ , P = NS ) .


Improvements in neurocognitive performance were significantly correlated with reductions in depression ratings posttreatment .


The AMI-SF score was significantly lower ( based on consistent answers from pre - to posttreatment ) in the ECT group ( @ % ) than in the APT group ( @ % , P = @ ) , indicating reduced consistency in autobiographical memory after ECT .


General neurocognitive function was unaffected by RUL brief-pulse ECT treatment and positively related to improved mood in bipolar depression .


Autobiographical memory consistency was reduced in patients treated with ECT .


The results suggest that ECT can be used in treatment-resistant bipolar depression without compromising general neurocognitive function .


The clinical relevance of reduced autobiographical memory consistency in the ECT group requires further investigation .


The purpose of this study was to evaluate the effectiveness of the application of analyzing treadmill , muscle strengthening , and balance training compared with a standard care intervention in patients with diabetic neuropathy .