No safety signals were identified and no serious adverse events were considered related to vaccination .


RTS , S/AS@ lots formulated from commercial-scale purified antigen bulk batches induced a consistent anti-CS antibody response , and the anti-CS GMT of pooled commercial-scale lots was non-inferior to that of a lot formulated from a pilot-scale antigen bulk batch .


In resource-poor settings , the standard of care to inform labour management is the partograph plus Pinard stethoscope for intermittent fetal heart rate ( FHR ) monitoring .


We compared FHR monitoring in labour using a novel , robust wind-up handheld Doppler with the Pinard as a primary screening tool for abnormal FHR on perinatal outcomes .


Prospective equally randomised clinical trial .


The labour and delivery unit of a teaching hospital in Kampala , Uganda .


Of the @ eligible antenatal women , @ women in active term labour , following uncomplicated pregnancies , were randomised to either the standard of care or not .


Intermittent FHR monitoring using Doppler .


Incidence of FHR abnormality detection , intrapartum stillbirth and neonatal mortality prior to discharge .


Age , parity , gestational age , mode of delivery and newborn weight were similar between study groups .


In the Doppler group , there was a significantly higher rate of FHR abnormalities detected ( incidence rate ratio ( IRR ) = @ , @ % CI @ to @ ) .


However , in this group , there were also higher though not statistically significant rates of intrapartum stillbirths ( IRR = @ , @ to @ ) and neonatal deaths ( IRR = @ , @ to @ ) .


Routine monitoring with a handheld Doppler increased the identification of FHR abnormalities in labour ; however , our trial did not find evidence that this leads to a decrease in the incidence of intrapartum stillbirth or neonatal death .


Determine if employment-based reinforcement can increase methadone treatment engagement and drug abstinence in out-of-treatment injection drug users .


This study was conducted from @ to @ in a therapeutic workplace in Baltimore , MD. .


After a @-week induction , participants ( N = @ ) could work and earn pay for @ weeks and were randomly assigned to Work Reinforcement , Methadone & Work Reinforcement , and Abstinence , Methadone & Work Reinforcement conditions .


Work Reinforcement participants had to work to earn pay .


Methadone & Work Reinforcement and Abstinence , Methadone , & Work Reinforcement participants had to enroll in methadone treatment to work and maximize pay .


Abstinence , Methadone , & Work Reinforcement participants had to provide opiate - and cocaine-negative urine samples to maximize pay .


Most participants ( @ % ) enrolled in methadone treatment during induction .


Drug abstinence increased as a graded function of the addition of the methadone and abstinence contingencies .


Abstinence , Methadone & Work Reinforcement participants provided significantly more urine samples negative for opiates ( @ % versus @ % ) and cocaine ( @ % versus @ % ) than Work Reinforcement participants .


Methadone & Work Reinforcement participants provided significantly more cocaine-negative samples than Work Reinforcement participants ( @ % versus @ % ) .


The therapeutic workplace can promote drug abstinence in out-of-treatment injection drug users .


Clinical trial registration number : NCT@ .


Mastectomy flap necrosis is a common complication of immediate breast reconstruction that impacts recovery time and reconstructive success .


Nitroglycerin ointment is a topical vasodilator that has been shown to improve skin flap survival in an animal model .


The objective of this study was to evaluate whether the application of nitroglycerin ointment to the breast skin after mastectomy and immediate reconstruction causes a decrease in the rate of mastectomy flap necrosis compared with placebo .


This study was conducted as a randomized controlled trial and included patients aged @ to @ years undergoing mastectomy and immediate breast reconstruction at the University of British Columbia-affiliated hospitals ( Vancouver , British Columbia , Canada ) .


Patients with a medical history that precluded the administration of nitroglycerin were excluded from the study .


The target sample size was @ patients .


Nitroglycerin ointment ( @ mg ) or a placebo was applied to the mastectomy skin at the time of surgical dressing .


The trial was stopped at the first interim analysis after @ patients had been randomized ( @ to the treatment group and @ to the placebo group ) .


Mastectomy flap necrosis developed in @ patients ( @ percent ) receiving placebo and in @ patients ( @ percent ) receiving nitroglycerin ointment ; the between-group difference was @ percent ( p = @ ; @ percent CI , @ to @ percent ) .


Postoperative complications were similar in both groups -LSB- nitroglycerin , @ percent ( @ of @ ) ; placebo , @ percent ( @ of @ ) -RSB- .


In patients undergoing mastectomy and immediate reconstruction , there was a marked reduction in mastectomy flap necrosis in patients who received nitroglycerin ointment .


Nitroglycerin ointment application is a simple , safe , and effective way to help prevent mastectomy flap necrosis .


Therapeutic , I.


To evaluate maternal-newborn outcomes with immediate or expectantly managed preeclampsia first diagnosed at @-@ weeks .


Late preterm patients with preeclampsia without severe features were randomly assigned to immediate delivery ( n = @ ) or expectant management ( n = @ ) until @ weeks gestation or earlier if severe features developed .


Data were analyzed by appropriate tests for continuous or categorical outcomes with differences considered significant if p < @ .


The two groups were similar at presentation .


@ % of those expectantly managed developed severe features of preeclampsia within @ hours versus @ % in the immediately delivered group ( p < @ ) .


Immediate delivery did not significantly increase cesarean delivery or neonatal morbidity .


Immediate delivery of the late preterm patient with preeclampsia significantly lessens her development of severe features without significantly increasing newborn risks .


For the expectantly managed late preterm patient with preeclampsia , close surveillance for the first @ hours following diagnosis and twice weekly thereafter appears prudent .


Reliable saphenous nerve blockade is a desirable complement to popliteal sciatic nerve blockade for foot and ankle surgery .


We compared two promising ultrasound-guided techniques , the supine adductor canal ( AC ) technique and the prone peri-saphenous branch of the descending genicular artery ( Peri-SBDGA ) technique , using @ mL of @ % lidocaine with epinephrine @:@,@ .


Following Research Ethics Board approval , we conducted a randomized single-blinded parallel-group trial in @ patients undergoing foot and ankle surgery at a single centre .


The primary endpoint was saphenous nerve ease of visualization ( @ = not visible ; @ = visible with difficulty ; and @ = easily visible ) .


Other endpoints included vascular landmark visualization ( @ = not visible ; @ = visible with colour flow Doppler ; @ = visible without colour flow Doppler ) , block success , onset , and complications .


Ninety-one patients were eligible for analysis .


Saphenous nerve visibility was not different between the groups ( visibility score = @ : AC group , n = @/@ -LSB- @ % -RSB- vs Peri-SBDGA group , @/@ -LSB- @ % -RSB- ; P = @ ) .


Vascular landmark visibility was better in the AC group than in the Peri-SBDGA group ( visibility score = @ : @/@ -LSB- @ % -RSB- vs @/@ -LSB- @ % -RSB- , respectively ; P = @ ) .


Block success rates were similar ( AC group , @/@ -LSB- @ % -RSB- vs Peri-SBDGA group , @/@ -LSB- @ % -RSB- ; P = @ ) , as were median -LSB- interquartile range -RSB- onset times ( AC group , @ -LSB- @-@ -RSB- min vs Peri-SBDGA group , @ -LSB- @-@ -RSB- min ; P = @ ) .


In this randomized trial , we found no differences in nerve visibility , block success rate , or onset between the AC and Peri-SBDGA techniques of ultrasound-guided saphenous nerve blockade , although the former technique provided superior vascular landmark visibility .


Neither technique produced a sufficiently high success rate to provide reliable surgical anesthesia per se .


To compare the effectiveness of needle-free incision suture closure with butterfly tape and traditional secondary suturing techniques in treating incision infection .


Two hundred and twenty-three patients with incision infection following hepatobiliary surgery at a tertiary hospital were randomly divided into three groups : @ patients were closed by needle-free incision suture closure , which gradually closed the incision wound when drainage from incision infection was visibly decreased and healthy granulation tissues had grown ; @ patients were closed by butterfly bandage ; another @ patients were closed by traditional secondary suturing technique .


Healing time of incision infection was calculated from the beginning of dressing change to the healing of the incision .


Healing time in the needle-free incision suture closure group ( @ @ d ) was significantly shorter than that in the butterfly bandage group ( @ @ d ) and the traditional secondary suturing group ( @ @ d ) ( P < @ ) .


Healing time in the butterfly bandage group appeared to be slightly shorter than that in the secondary suture group , but the difference was not statistically significant ( P > @ ) .


Needle-free incision suture closure could gradually close the infection wound at the same time of drainage and dressing change , thereby shortening the healing time .


Laparoscopic procedures are generally thought to have better outcomes than open procedures .


Because of anatomical constraints , laparoscopic rectal resection may not be better because of limitations in performing an adequate cancer resection .


To determine whether laparoscopic resection is noninferior to open rectal cancer resection for adequacy of cancer clearance .


Randomized , noninferiority , phase @ trial ( Australasian Laparoscopic Cancer of the Rectum ; ALaCaRT ) conducted between March @ and November @ .


Twenty-six accredited surgeons from @ sites in Australia and New Zealand randomized @ patients with T@-T@ rectal adenocarcinoma less than @ cm from the anal verge .


Open laparotomy and rectal resection ( n = @ ) or laparoscopic rectal resection ( n = @ ) .


The primary end point was a composite of oncological factors indicating an adequate surgical resection , with a noninferiority boundary of = -@ % .


Successful resection was defined as meeting all the following criteria : ( @ ) complete total mesorectal excision , ( @ ) a clear circumferential margin ( @ mm ) , and ( @ ) a clear distal resection margin ( @ mm ) .


Pathologists used standardized reporting and were blinded to the method of surgery .


A successful resection was achieved in @ patients ( @ % ) in the laparoscopic surgery group and @ patients ( @ % ) in the open surgery group ( risk difference of -@ % -LSB- @ % CI , -@ % to -RSB- ; P = @ for noninferiority ) .


The circumferential resection margin was clear in @ patients ( @ % ) in the laparoscopic surgery group and in @ patients ( @ % ) in the open surgery group ( risk difference of -@ % -LSB- @ % CI , -@ % to @ % -RSB- ; P = @ ) , the distal margin was clear in @ patients ( @ % ) in the laparoscopic surgery group and in @ patients ( @ % ) in the open surgery group ( risk difference of -@ % -LSB- @ % CI , -@ % to @ % -RSB- ; P = @ ) , and total mesorectal excision was complete in @ patients ( @ % ) in the laparoscopic surgery group and @ patients ( @ % ) in the open surgery group ( risk difference of -@ % -LSB- @ % CI , -@ % to @ % -RSB- ; P = @ ) .


The conversion rate from laparoscopic to open surgery was @ % .


Among patients with T@-T@ rectal tumors , noninferiority of laparoscopic surgery compared with open surgery for successful resection was not established .


Although the overall quality of surgery was high , these findings do not provide sufficient evidence for the routine use of laparoscopic surgery .


Longer follow-up of recurrence and survival is currently being acquired .


Financial abuse of elders is an under acknowledged problem and professionals ' judgements contribute to both the prevalence of abuse and the ability to prevent and intervene .


In the absence of a definitive `` gold standard '' for the judgement , it is desirable to try and bring novice professionals ' judgemental risk thresholds to the level of competent professionals as quickly and effectively as possible .


This study aimed to test if a training intervention was able to bring novices ' risk thresholds for financial abuse in line with expert opinion .


A signal detection analysis , within a randomised controlled trial of an educational intervention , was undertaken to examine the effect on the ability of novices to efficiently detect financial abuse .


Novices ( n = @ ) and experts ( n = @ ) judged `` certainty of risk '' across @ scenarios ; whether a scenario constituted a case of financial abuse or not was a function of expert opinion .


Novices ( n = @ ) were randomised to receive either an on-line educational intervention to improve financial abuse detection ( n = @ ) or a control group ( no on-line educational intervention , n = @ ) .


Both groups examined @ scenarios of abuse ( @ `` signal '' scenarios of risk and @ `` noise '' scenarios of no risk ) .


After the intervention group had received the on-line training , both groups then examined @ further scenarios ( @ `` signal '' and @ `` noise '' scenarios ) .


Experts were more certain than the novices , pre ( Mean @ vs. @ ) and post intervention ( Mean @ vs. @ ) ; and more consistent .


The intervention group ( mean @ ) were more certain of abuse post-intervention than the control group ( mean @ , p = @ ) .


Signal detection analysis of sensitivity ( A ) and bias ( C ) revealed that this was due to the intervention shifting the novices ' tendency towards saying `` at risk '' ( C post intervention -@ ) and away from their pre intervention levels of bias ( C -@ ) .


Receiver operating curves revealed more efficient judgments in the intervention group .


An educational intervention can improve judgements of financial abuse amongst novice professionals .


Functional dyspepsia represents a frequent gastrointestinal disorder in clinical practice .


According to the Roma III criteria , functional dyspepsia can be classified into two types as the predominant symptom : epigastric pain and postprandial discomfort .


Even though the pathophysiology is still uncertain , the functional dyspepsia seems to be related to multiple mechanisms , among them visceral hypersensitivity , changes in the gastroduodenal motility and gastric accommodation and psychological factors .


Evaluate the effectiveness of acupuncture as a complementary to conventional treatment in functional dyspepsia patients .


Randomized clinical trial in which were enrolled patients with functional dyspepsia patients in according with Rome III criteria .


One group was submitted to drug therapy and specific acupuncture ( GI ) and the other to drug therapy and non-specific acupuncture ( GII ) .


The gastrointestinal symptoms , presence of psychiatric disorders and quality of life were evaluated , at the end and three months after treatment .


After @ weeks of treatment there was improvement of gastrointestinal symptoms in Group I ( @ @ vs @ @ ; P = @ ) and Group II ( @ @ vs @ @ ; P = @ ) .


Quality of life was significantly better in Group I than group II ( @ @ vs @ @ ; P = @ ) .


Anxiety ( @ % vs @ % ; P = @ ) and depression ( @ % vs @ % ; P = @ ) were significantly lower in Group I than group II .


When comparing the two groups after @ weeks of treatment , gastrointestinal symptoms ( @ @ vs @ @ ; P < @ ) and quality of life ( @ @ vs @ @ ; P = @ ) were significantly better in Group I than group II .


Three months after the treatment , gastrointestinal symptoms remained better only in Group I , when compared to the pre-treatment values ( @ @ vs @ @ ; P = @ ) .


In patients with functional dyspepsia the complementary acupuncture treatment is superior to conventional treatment .


Further studies with more patients are needed to confirm these findings .


Less than @ % of men with LUTS consult their doctor .


Patients consider the LUTS as physiological and are resigned to endure them .


It is necessary to foster awareness of the micturition disorders , to monitor their development and to assess the effectiveness of therapies .


At present the only validated test is the IPSS-Q@ , but in Italy it is used by only @ % of General Practitioners ( GPs ) .


Because the IPSS is complex and not easy to handle , we need a more simple test but nevertheless efficient .


The Italian Society of Urology ( SIU ) and the Italian Society for Interdisciplinary Primary Care ( SIICP ) presented the `` Quick Prostate Test '' ( QPT ) in November @ .


We aimed to evaluate the efficiency of QPT versus the IPSSQ@ and its suitability in primary care .


The QPT is composed of @ questions to be answered `` yes '' or `` no . ''


The answer `` yes '' just to one question makes `` positive '' the test .


We enrolled @ men , @ years old , suffering from BPH , extracted from the database of five GPs .


The patients were randomized into two arms : to the arm @ only QPT was administered , to verify efficiency of the test ; to the arm @ both the QPT that the IPSS-Q@ were administered .


Into the arm @ , the @ % has tested positive for QPT .


Into the arm @ , the @ % of patients with one or two positive responses to the QPT showed a moderate IPSSQ@ score ; the @ % of the patients with three positive responses to the QPT had a serious IPSS-Q@ score .


The GPs ( @ % ) have expressed the highest level of satisfaction for the QPT for the `` time of administration '' and for the `` simplicity '' of the test .


The experience with the QPT has shown that the test is efficient and suitable in the primary care setting .


We want to encourage the GPs to use the QPT for the monitoring of patients with lower urinary tract symptoms ( LUTS ) and to contribute to the validation of the test .


Use of antiretroviral treatment for HIV-@ infection has decreased AIDS-related morbidity and mortality and prevents sexual transmission of HIV-@ .


However , the best time to initiate antiretroviral treatment to reduce progression of HIV-@ infection or non-AIDS clinical events is unknown .


We reported previously that early antiretroviral treatment reduced HIV-@ transmission by @ % .


We aimed to compare the effects of early and delayed initiation of antiretroviral treatment on clinical outcomes .


The HPTN @ trial is a randomised controlled trial done at @ sites in nine countries .


We enrolled HIV-@-serodiscordant couples to the study and randomly allocated them to either early or delayed antiretroviral treatment by use of permuted block randomisation , stratified by site .


Random assignment was unblinded .


The HIV-@-infected member of every couple initiated antiretroviral treatment either on entry into the study ( early treatment group ) or after a decline in CD@ count or with onset of an AIDS-related illness ( delayed treatment group ) .


Primary events were AIDS clinical events ( WHO stage @ HIV-@ disease , tuberculosis , and severe bacterial infections ) and the following serious medical conditions unrelated to AIDS : serious cardiovascular or vascular disease , serious liver disease , end-stage renal disease , new-onset diabetes mellitus , and non-AIDS malignant disease .


Analysis was by intention-to-treat .


This trial is registered with ClinicalTrials.gov , number NCT@ .


@ people with HIV-@ infection and a serodiscordant partner were enrolled in the study ; @ were assigned early antiretroviral treatment and @ to the delayed treatment group ( two individuals were excluded from this group after randomisation ) .


Median CD@ counts at randomisation were @ ( IQR @-@ ) cells per L in patients assigned to the early treatment group and @ ( @-@ ) cells per L in those allocated delayed antiretroviral treatment .


In the delayed group , antiretroviral treatment was initiated at a median CD@ count of @ ( IQR @-@ ) cells per L. Primary clinical events were reported in @ individuals assigned to early treatment initiation versus @ people allocated to delayed antiretroviral treatment ( hazard ratio @ , @ % CI @-@ ; p = @ ) .


New-onset AIDS events were recorded in @ participants assigned to early antiretroviral treatment versus @ allocated delayed initiation ( @ , @-@ ; p = @ ) , tuberculosis developed in @ versus @ patients , respectively ( @ , @-@ , p = @ ) , and primary non-AIDS events were rare ( @ in the early group vs nine with delayed treatment ) .


In total , @ primary and secondary outcomes occurred in the early treatment group ( incidence @ per @ person-years , @ % CI @-@ ) versus @ in the delayed treatment group ( @ per @ person-years , @-@ ; p = @ ) .


@ people died , @ who were allocated to early antiretroviral treatment and @ who were assigned to the delayed treatment group .


Early initiation of antiretroviral treatment delayed the time to AIDS events and decreased the incidence of primary and secondary outcomes .


The clinical benefits recorded , combined with the striking reduction in HIV-@ transmission risk previously reported , provides strong support for earlier initiation of antiretroviral treatment .


To test an intervention bundle for thirst intensity , thirst distress , and dry mouth , which are among the most pervasive , intense , distressful , unrecognized , and undertreated symptoms in ICU patients , but for which data-based interventions are lacking .


This was a single-blinded randomized clinical trial in three ICUs in a tertiary medical center in urban California .


A total of @ cognitively intact patients reporting thirst intensity ( TI ) and/or thirst distress ( TD ) scores @ on @-@ numeric rating scales ( NRS ) were randomized to intervention or usual care groups .


A research team nurse ( RTN # @ ) obtained patients ' pre-procedure TI and TD scores and reports of dry mouth .


She then administered a thirst bundle to the intervention group : oral swab wipes , sterile ice-cold water sprays , and a lip moisturizer , or observed patients in the usual care group .


RTN # @ , blinded to group assignment , obtained post-procedure TI and TD scores .


Up to six sessions per patient were conducted across @ days .


Multilevel linear regression determined that the average decreases in TI and TD scores from pre-procedure to post-procedure were significantly greater in the intervention group ( @ and @ NRS points , respectively ) versus the usual care group ( @ and @ points , respectively ) ( p < @ ) .


The usual care group was @ times more likely than the intervention group to report dry mouth for each additional session on day @ .


This simple , inexpensive thirst bundle significantly decreased ICU patients ' thirst and dry mouth and can be considered a practice intervention for patients experiencing thirst .


This study aimed to investigate the role of the effectiveness of camel milk ( CM ) ( raw and boiled ) on thymus and activation-regulated chemokine ( TARC ) serum levels and childhood autism rating scale ( CARS ) score in subjects with autism and compared to placebo group ( cow milk ) .


Forty-five subjects diagnosed with autism were randomly assigned to receive boiled CM for group I ( n = @ ) , raw CM for group II ( n = @ ) , and placebo for group III ( n = @ ) for @ wk .


Measures included changes in professionally completed CARS score and blood samples for TARC serum level were taken before and after milk consumption of @ml per day in children 's regular daily diet .


The serum levels of TARC decreased significantly ( P = @ ) in boiled CM and in raw CM group ( P = @ ) too , but no effect was observed ( P = @ ) in placebo group .


Furthermore , significant improvements were observed in CARS score ( P = @ ) in raw CM group only .


There were no significant relationships between the serum of TARC level and the CARS score , age , or gender for any group .


CM administered for @ wk significantly improved clinical measurements of autism severity and decreased serum level of TARC in autistic children , but subsequent studies are recommended .


Single-photon emission computed tomography ( SPECT ) myocardial perfusion imaging is an accepted method for reflecting the pathophysiological significance of lesions detected by coronary angiography .


However , it has an inherent drawback in terms of false-positive perfusion defects for the inferior myocardial wall .


To overcome this problem , different acquisition techniques have been proposed , including the computed tomographic-based attenuation correction method .


In this respect , a new imaging technique , left supine lateral position SPECT myocardial perfusion imaging with technetium-@m methoxyisobutylisonitrile ( Tc-@m MIBI ) , has been proposed to eliminate this problem and its value has been investigated in this report .


Sixty-two patients were prospectively and randomly enrolled in this study .


They underwent Tc-@m MIBI SPECT in the supine , prone , left lateral , and sitting positions after an adequate stress test on the same day.The presence and extent of defects on stress images were noted in the supine image data set for the @ myocardial segments , which were then labeled as @ or @ if a defect was present or absent , respectively .


This evaluation sequence was repeated in all other image data sets .


When defects persisted in other scan positions it was regarded as true positive , and when they were resolved they were regarded as false positive .


By this means , the percentages of resolving perfusion defects by that imaging position were calculated for each observer per positional pair under comparison .


From six interpretations carried out by the nuclear medicine physicians , @ = @ four-fold tables in @ segments were analyzed for discrepancies between position pairs .


In @ of @ discrepant interpretations , defects observed in any of the other positions were resolved in the lateral position .


Only in two evaluations of one observer were the discrepancies against lateral positioning for the anterior wall .


If the inferior wall was considered alone , it was clearly obvious that lateral positioning was more accurate than the other positions.Intraobserver evaluation showed the methodology to be highly reproducible.The SPECT findings were concordant with coronary angiography results in selected patients .


Visual and quantitative evaluations of the variation in inferior wall activity lead us to suggest that SPECT imaging with Tc-@m MIBI be performed in the left lateral position to allow better visualization of the inferior and septal walls in those departments not able to utilize computed tomographic attenuation correction .


To compare the growth of HIV-exposed children receiving @ of @ complementary foods after prevention of mother-to-child HIV transmission through maternal lifelong antiretroviral therapy ( ART ) .


In rural Malawi , @ HIV-infected pregnant women were consecutively identified and offered ART , without consideration of their CD@ counts .


Mothers were supported to exclusively breast-feed and children tested for HIV status at @ and @ months of age .


From this group , @ HIV-exposed children were enrolled and randomized to receive micronutrients with either whole milk powder or a ready-to-use complementary food ( RUF ) , until the child reached @ months of age .


Children were followed until @ months of age .


HIV-free survival at @ months was @ % ( @ % confidence interval : @ % to @ % ) .


Exclusive breast-feeding for the first @ months of life was practiced in @ % of the children .


At @ months of age , @ % of the children continued to be breast-fed .


At @ months of age , infants had a weight-for-height z score of @ @ ( mean SD ) and length-for-age z score of -@ @ .


The decrease in length-for-age z score among children receiving RUF at @ months of age was greater than that seen in those receiving milk powder ( -@ @ vs -@ @ , P = @ ) .


Mean weight-for-height z score was > @ at @ and @ months of age in both groups .


HIV-free survival @ % at @ months was achieved with maternal ART while either milk powder or RUF as a complementary food preserved child anthropometry .


Breast-feeding by mothers receiving ART was acceptable .


Severe infections , often requiring ICU admission , have been associated with persistent cognitive dysfunction .


Less severe infections are more common and whether they are associated with an increased risk of dementia is unclear .


We determined the association of pneumonia hospitalization with risk of dementia in well-functioning older adults .


Secondary analysis of a randomized multicenter trial to determine the effect of Gingko biloba on incident dementia .


Five academic medical centers in the United States .


Healthy community volunteers ( n = @,@ ) with a median follow-up of @ years .


None .


We identified pneumonia hospitalizations using International Classification of Diseases , @th Edition-Coding Manual codes and validated them in a subset .


Less than @ % of pneumonia cases necessitated ICU admission , mechanical ventilation , or vasopressor support .


Dementia was adjudicated based on neuropsychological evaluation , neurological examination , and MRI .


Two hundred twenty-one participants ( @ % ) incurred at least one hospitalization with pneumonia ( mean time to pneumonia = @ yr ) .


Of these , dementia was developed in @ ( @ % ) after pneumonia , with half of these cases occurring @ years after the pneumonia hospitalization .


Hospitalization with pneumonia was associated with increased risk of time to dementia diagnosis ( unadjusted hazard ratio = @ ; CI , @-@ @ ; p < @ ) .


The association remained significant when adjusted for age , sex , race , study site , education , and baseline mini-mental status examination ( hazard ratio = @ ; CI , @-@ @ ; p < @ ) .


Results were unchanged when additionally adjusted for smoking , hypertension , diabetes , heart disease , and preinfection functional status .


Results were similar using propensity analysis where participants with pneumonia were matched to those without pneumonia based on age , probability of developing pneumonia , and similar trajectories of cognitive and physical function prior to pneumonia ( adjusted prevalence rates , @ vs @ cases per @,@ person-years ; adjusted prevalence rate ratio = @ ; CI , @-@ @ ; p = @ ) .


Sensitivity analyses showed that the higher risk also occurred among those hospitalized with other infections .


Hospitalization with pneumonia is associated with increased risk of dementia .


Alpha glucosidase inhibitor ( GI ) attenuates postprandial hyperglycemia ( PPH ) and reduces the risk of cardiovascular events in patients with impaired glucose tolerance or type @ diabetes .


Dipeptidyl peptidase @ ( DPP-@ ) inhibitors also attenuate PPH .


PPH is one of the factors leading to endothelial dysfunction which is an early event in the pathogenesis of atherosclerosis .


Furthermore , DPP-@ inhibitors protect endothelial function through a GLP-@-dependent mechanism .


However , the impact of these two types of drugs on endothelial dysfunction in patients with type @ diabetes has not been fully elucidated .


We compared the effects of sitagliptin , a DPP-@ inhibitor , and voglibose , an alpha GI , on endothelial function in patients with diabetes .


We conducted a randomized prospective multicenter study in @ patients with type @ diabetes who did not achieve the treatment goal with sulfonylurea , metformin or pioglitazone treatment ; @ patients received sitagliptin treatment and @ patients , voglibose treatment .


The flow-mediated dilatation ( FMD ) of the brachial artery was measured in the fasting state at baseline and after @weeks of treatment .


The primary endpoint was a change in FMD ( FMD ) from the baseline to the end of follow-up .


The effects of sitagliptin and voglibose on FMD were assessed by ANCOVA after adjustment for the baseline FMD , age , sex , current smoking , diabetes duration and body mass index .


Secondary efficacy measures included changes in HbA@c , GIP , GLP-@ , C-peptide , CD@ , lipid profile , oxidative stress markers , inflammatory markers and eGFR and any adverse events .


FMD was significantly improved after @weeks of treatment in both groups , and there was no significant difference in FMD between the two groups .


There were no significant differences in changes in HbA@c , GIP , GLP-@ , C-peptide , lipid profile , oxidative stress marker , inflammatory marker and eGFR between the two groups .


Compared with voglibose , sitagliptin significantly increased the circulating CD@ , a marker of endothelial progenitor cells .


Adverse events were observed in @ patients in only the voglibose group ( diarrhea @ , nausea @ , edema @ and abdominal fullness @ ) .


Sitagliptin improved endothelial dysfunction just as well as voglibose in patients with type @ diabetes .


Sitagliptin had protective effects on endothelial function without adverse events .


Smoking among adolescents has been linked to a variety of adverse and long term health consequences .


`` Susceptibility to smoking '' or the lack of cognitive commitment to abstain from smoking is an important predictor of adolescent smoking .


In @ , we conducted a study to determine the psycho-sociological factors associated with susceptibility to smoking among secondary school students in the district of Kota Tinggi , Johor .


Two thousand seven hundred students were randomly selected by proportional stratified sampling .


Analyses on @,@ non-smoking students revealed that prevalence of adolescents susceptible to smoking was @ % .


Male gender ( aOR = @ , @ % CI = @-@ @ ) , poor academic achievement ( aOR @ , @ % CI @-@ @ ) , ever-smoker ( aOR @ , @ % CI @-@ @ ) and having a smoking friend ( aOR @ , @ % CI @-@ @ ) were associated with susceptibility to smoking , while having the perception that smoking prohibition in school was strictly enforced ( aOR @ , @ % CI @-@ @ ) , and had never seen friends smoking in a school compound ( aOR @ , @ % CI @-@ @ ) were considered protective factors


These results indicate that follow-up programmes need to capitalise on the modifiable factors related to susceptibility to smoking by getting all stakeholders to be actively involved to stamp out smoking initiation among adolescents .


To compare effectiveness of the generic form of gabapentin with its original form .


A single-blind evaluation randomized controlled trial ( RCT ) of patients that were diagnosed with low back pain with suspected neuropathic component at the Department of Rehabilitation Medicine , King Chulalongkorn Memorial Hospital were included in the present study .


Patients were randomized into two treatment groups .


The first group received gabapentin generic form ( GGF ) or Gabapentin Sandoz , whereas the other received gabapentin original form ( GOF ) or Neurontin .


The primary endpoint was the VisualAnalogue Scale ( VAS ) pain score .


The secondary endpoints were the Thai version of the Oswestry low back pain disability index ( ODI ) score , lumbar spine 's range ofmotion , safety profiles , and average medical cost .


Non-inferiority was pre-specified at @ % .


The amount of medication was increased to maintain VAS less than @ mm and tapered off in case of adverse event .


Forty-one patients , GGF @ and GOF @ , had completed the study .


At @th week , the visual analogue scale ( VAS ) and ODI scores significantly decreased in both groups .


Mean and standard deviation ( SD ) of VAS improvement were @ + / - @ mm for the GGF group versus @ + / - @ mm for the GOF group ( p = @ ) , within pre-specified @ % non-inferiority margin ( difference @ mm @ % CI-@ @ mm , @ mm ) .


Mean ODI improvement was @ % for the GGF group versus @ % for the GOF group ( p = @ ) , within pre-specified @ % non-inferiority margin , ( difference @ , @ % CI = -@ % , @ % ) .


Both groups have significantly gainedflexion of the lumbar spine .


Both groups revealed similar safety profiles .


The GGF group showed significantly lower average cost for medications ( @,@ baht ) .


In comparison with the GOF ( Neurontin ) group , the non-inferior effectiveness for pain reduction and improvement of back function has been revealed in the GGF ( Gabapentin Sandoz ) group .


Similar safety profiles were demonstrated in both groups .


The average medication cost of GGF is much lower than GOF ( @ times ) .


Important changes are occurring in how the medical profession approaches assessing and maintaining competence .


Physician support for such changes will be essential for their success .


To describe physician attitudes towards assessing and maintaining competence .


Cross-sectional internet survey .


Random sample of @,@ American College of Physicians members who were eligible to participate in the American Board of Internal Medicine Maintenance of Certification program .


Questions assessed physicians ' attitudes and experiences regarding : @ ) self-regulation , @ ) feedback on knowledge and clinical care , @ ) demonstrating knowledge and clinical competence , @ ) frequency of use and effectiveness of methods to assess or improve clinical care , and @ ) transparency .


Surveys were completed by @ of @ eligible respondents ( @ % ) .


Eighty percent reported it was important ( somewhat/very ) to receive feedback on their knowledge , and @ % considered it important ( somewhat/very ) to get feedback on their quality of care .


However , only @ % reported that they receive useful feedback on their knowledge most/all of the time , and @ % reported receiving useful feedback on their clinical care most/all of the time .


Seventy-five percent agreed that participating in programs to assess their knowledge is important to staying up-to-date , yet only @ % reported participating in such programs within the last @ years .


The majority ( @ % ) believed physicians should be required to demonstrate their knowledge via a secure examination every @-@ years .


Support was low for Specialty Certification Boards making information about physician competence publically available , with respondents expressing concern about patients misinterpreting information about their Board Certification activities .


A gap exists between physicians ' interest in feedback on their competence and existing programs ' ability to provide such feedback .


Educating physicians about the importance of regularly assessing their knowledge and quality of care , coupled with enhanced systems to provide such feedback , is needed to close this gap .


The aim of this study is to compare the microleakage of Class II dental composite resin restorations which have been cured by three different LED ( light emitting diode ) light curing modes compared to control samples cured by QTH ( quartz tungsten halogen ) light curing units ( LCUs ) , to determine the most effective light curing unit and mode of curing .


In this experimental study , class II cavities were prepared on @ sound human premolars which have been extracted for orthodontic treatment .


The teeth were randomly divided into four groups ; three experimental and one control group of @ teeth each .


Experimental groups were cured by either conventional , pulse-delay , or ramped curing modes of LED .


The control group was cured for @ seconds by QTH .


The restorations were thermocycled ( @ times , between @ and @C , for @ seconds dwell time ) , dyed , sectioned mesio-distally and viewed under stereo-microscope ( @ ) magnification .


Teeth were then scored on a @ to @ scale based on the amount of microleakage .


The data were analyzed by Chi-square test.No significant difference was demonstrated between the different LCUs ( light curing units ) , or modes of curing , at the enamel side ( p > @ ) .


At the dentin side , all modes of LED curing could significantly reduce microleakage ( p < @ ) .


The results suggest that slow start curing improves marginal integrity and seal .


High intense curing endangers those aims .


Comparison between the three LED mode cured composite resin restorations and QTH curing showed LED curing in all modes is more effective than QTH for reducing microleakage .


Both LED and QTH almost completely eliminate the microleakage on the enamel side , however none of them absolutely eliminated microleakage on the dentin side .


Determine whether absorbable or nonabsorbable mesh in repair of large hiatus hernias reduces the risk of recurrence , compared with suture repair .


Repair of large hiatus hernia is associated with radiological recurrence rates of up to @ % , and to improve outcomes mesh repair has been recommended .


Previous trials have shown less short-term recurrence with mesh , but adverse outcomes limit mesh use .


Multicentre prospective double blind randomized controlled trial of @ methods of repair : sutures versus absorbable mesh versus nonabsorbable mesh .


Primary outcome-hernia recurrence assessed by barium meal radiology and endoscopy at @ months .


Secondary outcomes-clinical symptom scores at @ , @ , @ , and @ months .


A total of @ patients enrolled : @ sutures , @ absorbable mesh , and @ nonabsorbable mesh .


Among them , @ % were followed up to @ months , with objective follow-up data in @ % .


A recurrent hernia ( any size ) was identified in @ % after suture repair , @ % after absorbable mesh , and @ % after nonabsorbable mesh ( P = @ ) .


Clinical outcomes were similar , except less heartburn at @ and @ months and less bloating at @ months with nonabsorbable mesh ; more heartburn at @ months , odynophagia at @ month , nausea at @ and @ months , wheezing at @ months ; and inability to belch at @ months after absorbable mesh .


The magnitudes of the clinical differences were small .


No significant differences were seen for recurrent hiatus hernia , and the clinical differences were unlikely to be clinically significant .


Overall outcomes after sutured repair were similar to mesh repair .


To examine the effects of Diet ( D ) and Exercise ( E ) interventions on cardiovascular fitness , waist circumference , blood lipids , glucose metabolism , inflammation markers , insulin-like growth factor @ ( IGF-@ ) and blood pressure in overweight and obese lactating women .


At @-@ wk postpartum , @ Swedish women with a self-reported pre-pregnancy BMI of @-@ kg/m ( @ ) were randomized to a @-wk behavior modification treatment with D , E , both or control using a @ factorial design .


The goal of D treatment was to reduce body weight by @ kg/wk , accomplished by decreasing energy intake by @ kcal/d and monitoring weight loss through self-weighing .


The goal of E treatment was to perform @ @-min walks per wk at @-@ % of max heart-rate using a heart-rate monitor .


Effects were measured @ wk and @ y after randomization .


General Linear Modeling was used to study main and interaction effects adjusted for baseline values of dependent variable .


There was a significant main effect of the D treatment , decreasing waist circumference ( P = @ ) , total cholesterol ( P = @ ) , LDL-cholesterol ( P = @ ) and fasting insulin ( P = @ ) , at the end of the @-wk treatment .


The decreased waist circumference ( P < @ ) and insulin ( P = @ ) was sustained and HDL-cholesterol increased ( P = @ ) at the @-y follow-up .


No effects from the E treatment or any interaction effects were observed .


Dietary behavior modification that produced sustained weight loss among overweight and obese lactating women also improved risk factors for cardiovascular disease and type @ diabetes .


This intervention may not only reduce weight-related risks with future pregnancies but also long-term risk for metabolic disease .


There is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence ( NICE ) osteoarthritis ( OA ) guidelines in primary care , or of the effect these recommendations have on the condition .


The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation ( MOAC ) , implementing the core recommendations from the NICE OA guidelines in primary care .


Secondary aims are to investigate the impact , feasibility and acceptability of the MOAC intervention ; to develop and evaluate a training package for management of OA by general practitioners ( GPs ) and practice nurses ; test the feasibility of deriving ` quality markers ' of OA management using a new consultation template and medical record review ; and describe the uptake of core NICE OA recommendations in participants aged @years and over with joint pain .


A mixed methods study with a nested cluster randomised controlled trial .


This study was developed according to a defined theoretical framework ( the Whole System Informing Self-management Engagement ) .


An overarching model ( the Normalisation Process Theory ) will be employed to undertake a comprehensive ` whole-system ' evaluation of the processes and outcomes of implementing the MOAC intervention .


The primary outcome is general physical health ( Short Form-@ Physical component score -LSB- PCS -RSB- ) ( Ware @ ) .


The impact , acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review .


Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews .


The impact , acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires , semi-structured interviews , and observations .


The main output from the study will be to determine whether the MOAC intervention is clinically and cost effective .


Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care , training and educational materials , and resources for patients and professionals regarding supported self-management and uptake of NICE guidance .


Postoperative debridement is a controversial subject in the rhinology literature .


The objective of this randomized controlled trial was to determine the effect of regular debridement versus no debridement on disease-specific outcomes and patient inconvenience .


Patients with chronic rhinosinusitis with polyposis who were to undergo basic sinus surgery ( antrostomy , ethmoidectomy , and polypectomy ) were randomized to either debridement ( at postoperative weeks @ and @ ) or no debridement , and their outcomes were assessed at @ weeks and at @ months with the Lund-Kennedy Endoscopic Score ( LKES ) , the Sino-Nasal Outcome Test-@ ( SNOT-@ ) , a visual analog scale for postoperative pain , and a novel scoring system for postoperative inconvenience ( Post-Operative Inconvenience Scale ; POIS ) .


All patients were instructed to use high-volume saline rinses twice daily .


At @ weeks after operation , there was no difference between the groups in regard to LKESs ( control group , @ of @ ; debridement group , @ of @ ; p = @ ) or SNOT scores ( control group , @ ; debridement group , @ ; p = @ ) .


The visual analog scale pain scores showed significance ( control group , @ mm ; debridement group , @ mm ; p = @ ) , as did the POIS scores ( control group , @ ; debridement group , @ ; p = @ ) .


At @ months after surgery , again no difference was seen between the groups on either LKESs or SNOT scores .


In our patient population , debridement after surgery did not affect disease-specific outcomes .


Cardiovascular diseases are rising as a cause of death and disability in China .


To improve outcomes for patients with these conditions , the Chinese government , academic researchers , clinicians , and > @ hospitals have created China Patient-Centered Evaluative Assessment of Cardiac Events ( China PEACE ) , a national network for research and performance improvement .


The first study from China PEACE , the Retrospective Study of Acute Myocardial Infarction ( China PEACE-Retrospective AMI Study ) , is designed to promote improvements in acute myocardial infarction ( AMI ) quality of care by generating knowledge about the characteristics , treatments , and outcomes of patients hospitalized with AMI across a representative sample of Chinese hospitals during the past decade .


The China PEACE-Retrospective AMI Study will examine > @ @ patient records from @ hospitals identified using a @-stage cluster sampling design within economic-geographic regions .


Records were chosen from @ , @ , and @ to identify temporal trends .


Data quality will be monitored by a central coordinating center and will , in particular , address case ascertainment , data abstraction , and data management .


Analyses will examine patient characteristics , diagnostic testing patterns , in-hospital treatments , in-hospital outcomes , and variation in results by time and site of care .


In addition to publications , data will be shared with participating hospitals and the Chinese government to develop strategies to promote quality improvement .


The China PEACE-Retrospective AMI Study is the first to leverage the China PEACE platform to better understand AMI across representative sites of care and during the past decade in China .


The China PEACE collaboration among government , academicians , clinicians , and hospitals is poised to translate research about trends and patterns of AMI practices and outcomes into improved care for patients .


Whereas thermal ablation of incompetent saphenous veins is highly effective , all heat-based ablation techniques require the use of perivenous subfascial tumescent anesthesia , involving multiple needle punctures along the course of the target vein .


Preliminary evidence suggests that cyanoacrylate embolization ( CAE ) may be effective in the treatment of incompetent great saphenous veins ( GSVs ) .


We report herein early results of a randomized trial of CAE vs radiofrequency ablation ( RFA ) for the treatment of symptomatic incompetent GSVs .


Two hundred twenty-two subjects with symptomatic GSV incompetence were randomly assigned to receive either CAE ( n = @ ) with the VenaSeal Sapheon Closure System ( Sapheon , Inc , Morrisville , NC ) or RFA ( n = @ ) with the ClosureFast system ( Covidien , Mansfield , Mass ) .


After discharge , subjects returned to the clinic on day @ and again at months @ and @ .


The study 's primary end point was closure of the target vein at month @ as assessed by duplex ultrasound and adjudicated by an independent vascular ultrasound core laboratory .


Statistical testing focused on showing noninferiority with a @ % delta conditionally followed by superiority testing .


No adjunctive procedures were allowed until after the month @ visit , and missing month @ data were imputed by various methods .


Secondary end points included patient-reported pain during vein treatment and extent of ecchymosis at day @ .


Additional assessments included general and disease-specific quality of life surveys and adverse event rates .


All subjects received the assigned intervention .


By use of the predictive method for imputing missing data , @-month closure rates were @ % for CAE and @ % for RFA .


All primary end point analyses , which used various methods to account for the missing data rate ( @ % ) , showed evidence to support the study 's noninferiority hypothesis ( all P < @ ) ; some of these analyses supported a trend toward superiority ( P = @ in the predictive model ) .


Pain experienced during the procedure was mild and similar between treatment groups ( @ and @ for CAE and RFA , respectively , on a @-point scale ; P = @ ) .


At day @ , less ecchymosis in the treated region was present after CAE compared with RFA ( P < @ ) .


Other adverse events occurred at a similar rate between groups and were generally mild and well tolerated .


CAE was proven to be noninferior to RFA for the treatment of incompetent GSVs at month @ after the procedure .


Both treatment methods showed good safety profiles .


CAE does not require tumescent anesthesia and is associated with less postprocedure ecchymosis .


This exploratory study was the first study of remimazolam in patients to assess the safety and efficacy of different single doses for procedural sedation .


Patients scheduled to undergo a diagnostic upper gastrointestinal endoscopy were randomized to receive @ of @ doses of remimazolam or midazolam ( @ per group ) in a double-blind manner .


After a single dose of study drug to achieve sedation , patients underwent gastroscopy .


We assessed the success of the procedure , sedation levels , recovery from sedation , and safety .


A single dose of remimazolam resulted in a successful procedure in @ % , @ % , and @ % of patients in the low ( @ ) , middle ( @ ) , and high ( @ mg/kg ) dose groups compared with @ % of patients in the midazolam ( @ mg/kg ) dose group .


The onset of sedation was @ to @ minutes in the remimazolam dose groups compared with @ minutes for midazolam .


Because this was a single administration study , sedation could be maintained for as long as necessary to complete the procedure , using rescue midazolam or propofol .


Recovery from sedation was rapid for all treatment groups but was influenced by the choice of rescue medication .


There were no obvious differences in the safety profiles of remimazolam and midazolam .


This exploratory dose-finding study showed that a single administration of remimazolam ( @-@ @ mg/kg ) was capable of inducing rapid sedation with a quick recovery profile in patients undergoing a diagnostic upper gastrointestinal endoscopy .


The safety profile was favorable and appeared to be similar to that of midazolam , warranting further development of this short-acting compound .


The Solitaire Flow Restoration was approved by the FDA in @ for mechanical thrombolysis of proximal occlusion of intracranial arteries .


To compare the Solitaire FR device and the Merci/Penumbra ( previously FDA approved ) systems in terms of safety , clinical outcomes , and efficacy including radiographic brain parenchymal salvage .


Thirty-one consecutive patients treated with the Solitaire and @ patients with comparable baseline characteristics treated with Merci or Penumbra systems were included in the study .


Primary outcome measures included recanalization rate and modified Rankin Scale score at followup .


Secondary outcomes included length of procedure , incidence of symptomatic intracranial hemorrhage , @-day mortality , and radiographic analysis of percentage area salvage .


Compared with the Merci/Penumbra group , the Solitaire group showed a statistically significant improvement in favorable outcomes ( mRS @ ) ( @ % versus @ % , P = @ ) and symptomatic ICH rate ( @ versus @ % , P = @ ) with a trend towards higher recanalization rates ( @ % versus @ % , P = @ ) and shorter length of procedure ( @ min versus @ min , P = @ ) .


Radiographic comparison also showed a significantly larger area of salvage in the Solitaire group ( @ % versus @ % , P = @ ) .


Our study suggests that the Solitaire system allows faster , safer , and more efficient thrombectomy than Merci or Penumbra systems .


Production and consumption of industrially processed food and drink products have risen in parallel with the global increase in overweight and obesity and related chronic non-communicable diseases .


The objective of this study was to analyze the relationship between household availability of processed and ultra-processed products and the prevalence of excess weight ( overweight plus obesity ) and obesity in Brazil .


The study was based on data from the @-@ Household Budget Survey involving a probabilistic sample of @,@ Brazilian households .


The units of study were household aggregates ( strata ) , geographically and socioeconomically homogeneous .


Multiple linear regression models were used to assess the relationship between the availability of processed and ultra-processed products and the average of Body Mass Index ( BMI ) and the percentage of individuals with excess weight and obesity in the strata , controlling for potential confounders ( socio-demographic characteristics , percentage of expenditure on eating out of home , and dietary energy other than that provided by processed and ultra-processed products ) .


Predictive values for prevalence of excess weight and obesity were estimated according to quartiles of the household availability of dietary energy from processed and ultra-processed products .


The mean contribution of processed and ultra-processed products to total dietary energy availability ranged from @ % ( lower quartile ) to @ % ( upper quartile ) .


Adjusted linear regression coefficients indicated that household availability of ultra-processed products was positively associated with both the average BMI and the prevalence of excess weight and obesity , whereas processed products were not associated with these outcomes .


In addition , people in the upper quartile of household consumption of ultra-processed products , compared with those in the lower quartile , were @ % more likely to be obese .


Greater household availability of ultra-processed food products in Brazil is positively and independently associated with higher prevalence of excess weight and obesity in all age groups in this cross-sectional study .


SpineCor is a relatively innovative brace for non-operative treatment of adolescent idiopathic scoliosis ( AIS ) .


However , the effectiveness of SpineCor still remains controversial .


The objective of the current study was to compare the treatment outcomes of SpineCor brace with that of rigid brace following the standardized Scoliosis Research Society ( SRS ) criteria on AIS brace study .


Females subjects with AIS and aged @-@ were randomly allocated into two groups undergoing treatment of SpineCor ( S Group , n = @ ) or rigid brace ( R Group , n = @ ) .


During SpineCor treatment , patients who had curve progression of > @ would be required to switch to rigid brace treatment .


The effectiveness of the two brace treatments was assessed using the SRS standardized criteria .


Before skeletal maturity , @ ( @ % ) patients in the S Group and @ ( @ % ) patient in the R Group had curve progression > @ ( P = @ ) .


At skeletal maturity , @ of the @ ( @ % ) patients who failed with SpineCor bracing showed control from further progression by changing to rigid bracing .


At the latest follow-up with a mean duration of @ months after skeletally maturity , @ % of patients who were successfully treated by rigid brace showed further curve progression beyond skeletal maturity , versus @ % of patients in the SpineCor group ( P > @ ) .


For both groups , the primary curves were slightly improved at the time of brace weaning , but additionally increased at the latest follow-up , with a rate of @ per year for post-maturity progression .


Curve progression rate was found to be significantly higher in the SpineCor group when compared with the rigid brace group .


Changing to rigid bracing could control further curve progression for majority of patients who previously failed with SpineCor bracing .


For both SpineCor and rigid brace treatments , @-@ % of patients who were originally successfully treated by bracing would exhibit further curve progression beyond skeletal maturity .


The post-maturity progression rate was found to be @ per year in the current study , which was relatively greater than those reported before .


In vitro and animal studies have shown differential colonic fermentation of structurally different prebiotics .


We evaluated the impact of two structurally different prebiotics ( wheat bran extract ( WBE , containing arabinoxylan-oligosaccharides ) and oligofructose ) on colonic fermentation and markers of bowel health in healthy volunteers .


Nineteen healthy subjects completed a double-blind , cross-over randomized controlled trial .


Interventions with WBE , oligofructose or placebo for @ wk ( week @ : @ g/day ; week @ : @ g/day ) were separated by @-wk wash-out periods .


At the end of each study period , colonic fermentation was characterized through a metabolomics approach .


Fecal water genotoxicity and cytotoxicity were determined using the comet and WST-@ assay , respectively , as parameters of gut health .


Cluster analysis revealed differences in effects of WBE and oligofructose on colonic fermentation .


WBE , but not oligofructose , reduced fecal p-cresol ( p = @ ) and isovaleric acid concentrations ( p = @ ) , markers of protein fermentation .


Fecal water cytotoxicity was significantly lower after intake of WBE ( p = @ ) .


Both WBE - and oligofructose-intake tended to reduce fecal water genotoxicity compared to placebo ( WBE : p = @ ; oligofructose : p = @ ) .


Changes in fermentation were not related to changes in fecal water toxicity .


Structurally different prebiotics affect colonic fermentation and gut health in a different way .


Three decades of research suggests that prevention of iron deficiency anemia ( IDA ) in the primary care setting may be an unrealized and unique opportunity to prevent poor developmental outcomes in children .


A longitudinal study of infants with IDA showed that the developmental disadvantage persists long term despite iron therapy .


Early stages of iron deficiency , termed non-anemic iron deficiency ( NAID ) , provide an opportunity for early detection and treatment before progression to IDA .


There is little research regarding NAID , which may be associated with delayed development in young children .


The aim of this study is to compare the effectiveness of four months of oral iron treatment plus dietary advice , with placebo plus dietary advice , in improving developmental outcomes in children with NAID and to conduct an internal pilot study .


From a screening cohort , those identified with NAID ( hemoglobin @ g/L and serum ferritin < @ g/L ) are invited to participate in a pragmatic , multi-site , placebo controlled , blinded , parallel group , superiority randomized trial .


Participating physicians are part of a primary healthcare research network called TARGet Kids !


Children between @ and @ months of age and identified with NAID are randomized to receive four months of oral iron treatment at @ mg/kg/day plus dietary advice , or placebo plus dietary advice ( @ per group ) .


The primary outcome , child developmental score , is assessed using the Mullen Scales of Early Learning at baseline and at four months after randomization .


Secondary outcomes include an age appropriate behavior measure ( Children 's Behavior Questionnaire ) and two laboratory measures ( hemoglobin and serum ferritin levels ) .


Change in developmental and laboratory measures from baseline to the end of the four-month follow-up period will be analyzed using linear regression ( analysis of covariance method ) .


This trial will provide evidence regarding the association between child development and NAID , and the effectiveness of oral iron to improve developmental outcomes in children with NAID .


The sample size of the trial will be recalculated using estimates taken from an internal pilot study .


This study prospectively evaluates and compares the treatment efficacy of botulinum toxin injection under electromyography guidance ( EMG group ) and percutaneous botulinum toxin injection under flexible fiberscopic guidance ( fiberscopy group ) .


Thirty patients with adductor spasmodic dysphonia ( ADSD ) , who had never received treatment , were randomly allocated into EMG - or fiberscopy-guided botulinum toxin injections between March @ and February @ .


We assessed acoustic and aerodynamic voice parameters , and the voice handicap index ( VHI ) before injection and at @ , @ , and @ months after injection .


The mean total dosage of botulinum toxin was similar for both groups : @ @ U for the EMG group and @ @ U for the fiberscopy group ( P > @ ) .


There were no significant differences in outcomes between the two groups in either the duration of effectiveness or complications such as breathy voice and aspiration .


Botulinum toxin injection under fiberscopic guidance is a viable alternative to EMG-guided botulinum toxin injection for the treatment of adductor spasmodic dysphonia when EMG equipment is unavailable .


- Cell dysfunction is a core defect in T@DM , and chronic , sustained hyperglycemia has been implicated in progressive - cell failure , ie , glucotoxicity .


The aim of the present study was to examine the effect of lowering the plasma glucose concentration with dapagliflozin , a glucosuric agent , on - cell function in T@DM individuals .


Twenty-four subjects with T@DM received dapagliflozin ( n = @ ) or placebo ( n = @ ) for @ weeks , and a @-g oral glucose tolerance test ( OGTT ) and insulin clamp were performed before and after treatment .


Plasma glucose , insulin , and C-peptide concentrations were measured during the OGTT .


Dapagliflozin significantly lowered both the fasting and @-hour plasma glucose concentrations and the incremental area under the plasma glucose concentration curve ( G@-@ ) during OGTT by -@ @ mg/dL , -@ @ mg/dL , and -@ @ mg/dL min , respectively , compared to -@ @ , -@ @ , and -@ @ reductions in placebo-treated subjects ( both P < @ ) .


The incremental area under the plasma C-peptide concentration curve tended to increase in dapagliflozin-treated subjects , whereas it did not change in placebo-treated subjects .


Thus , C-Pep@-@ / G@-@ increased significantly in dapagliflozin-treated subjects , whereas it did not change in placebo-treated subjects ( @ @ vs @ @ ; P < @ ) .


Dapagliflozin significantly improved whole-body insulin sensitivity ( insulin clamp ) .


Thus , - cell function , measured as C-Pep@-@ / G@-@ insulin resistance , increased by @-fold ( P < @ ) in dapagliflozin-treated vs placebo-treated subjects .


Lowering the plasma glucose concentration with dapagliflozin markedly improves - cell function , providing strong support in man for the glucotoxic effect of hyperglycemia on - cell function .


Functional abdominal pain ( FAP ) is not only a highly prevalent disease but also poses a considerable burden on children and their families .


Untreated , FAP is highly persistent until adulthood , also leading to an increased risk of psychiatric disorders .


Intervention studies underscore the efficacy of cognitive behavioral treatment approaches but are limited in terms of sample size , long-term follow-up data , controls and inclusion of psychosocial outcome data .


In a multicenter randomized controlled trial , @ children aged @ to @ years who fulfill the Rome III criteria for FAP will be allocated to an established cognitive behavioral training program for children with FAP ( n = @ ) or to an active control group ( focusing on age-appropriate information delivery ; n = @ ) .


Randomization occurs centrally , blockwise and is stratified by center .


This study is performed in five pediatric gastroenterology outpatient departments .


Observer-blind assessments of outcome variables take place four times : pre - , post - , @ - and @-months post-treatment .


Primary outcome is the course of pain intensity and frequency .


Secondary endpoints are health-related quality of life , pain-related coping and cognitions , as well as self-efficacy .


This confirmatory randomized controlled clinical trial evaluates the efficacy of a cognitive behavioral intervention for children with FAP .


By applying an active control group , time and attention processes can be controlled , and long-term follow-up data over the course of one year can be explored .


When first approved in the European Union ( EU ) , the omalizumab dosing table had upper bodyweight and IgE limits of @kg and @IU/mL , respectively .


In this study , we assessed the safety , pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of omalizumab in patients with IgE/bodyweight combinations above those in the original dosing table .


A multicentre , open-label , parallel-group study assessed the safety , PK and PD of omalizumab in @ patients with mild-to-moderate allergic ( IgE-mediated ) asthma .


Patients received two subcutaneous injections of omalizumab at one of three dosage levels ( @ , @ , or @mg ) , chosen according to baseline IgE ( @-@IU / mL ) and bodyweight ( @-@kg ) , with a @-day interval between injections .


Overall , @ adverse events ( AEs ) , none of them serious , were reported by @ ( @ % ) patients .


Analysis of laboratory measurements , vital signs and ECG data revealed no adverse findings of clinical relevance .


The PK profile was consistent with previous data for lower doses .


Mean maximum decrease of free IgE from screening was @ % for all three doses , and mean free IgE concentrations remained < @ng/mL for at least @ weeks after the second dose .


The reductions in free IgE were consistent with levels previously associated with clinical improvements .


The safety and PK/PD findings from this study are consistent with previous data , and supported the extension of the omalizumab dosing table to include those patients with higher IgE/bodyweight combinations .


Clinical trial registry and registration number : clinicaltrials.gov ( NCT@ ) .


To test the hypothesis that the restrictive volume therapy decreases blood transfusion requirement during liver orthotopic transplantation ( OLT ) without increasing acute renal complications and hospital length stay .


We conducted a retrospective cohort study ( n = @ ) , randomized into @ groups : A ( liberal fluid strategy ) and B ( restrictive therapy ) .


We analyzed packed red blood cells ( PRBCs ) units , transfused units of fresh frozen plasma ( FFP ) , colloids , crystalloids , perioperative renal function , and hospital length stay .


For comparison of proportions , we used the ( @ ) test and Student t test to compare means ( parametric ) .


A logistic regression model was constructed to evaluate the association of all these variables with probability of PRBCs transfusion .


In group A , @ % of patients required intraoperative transfusion of PRBCs , with a mean of @ @ IU , compared with @ % in group B with a mean of @ @ IU ( P < @ ) .


We also found differences in the following variables : FFP transfusion rate was @ % ( mean , @ @ IU ) in group A and @ % ( mean , @ @ IU ) in B ( P < @ ) .


The amount of colloid was @ % ( mean , @ @ mL ) in group A and @ % ( mean , @ @ mL ) in B ( P = @ ) .


Platelet concentrates transfusion was @ % ( mean , @ @ IU ) in group A and @ % ( mean , @ @ IU ) in B ( P = @ ) .


As an important effect of restrictive fluid therapy , renal function was assessed ; no differences in mean creatinine or acute renal failure in the immediate postoperative period were observed .


There was no difference in hospital length stay .


Logistic regression modelling identified @ variables as significant predictors of transfusion : Fluid administration policy , preoperative hemoglobin and FFP units transfused .


Furthermore , an increase of preoperative hemoglobin is associated with a lesser probability of transfusion .


These results show that fluid restriction management for OLT decreased blood products requirements , especially FFP .


This could suggest that liberal fluid management may aggravate , rather than prevent , bleeding in these patients .


We did observed any no difference in failure of renal function .


Typhoid vaccination is a public health priority in developing countries where young children are greatly affected by typhoid fever .


Because present vaccines are not recommended for children younger than @ years , the Novartis Vaccines Institute for Global Health developed a conjugate vaccine ( Vi-CRM@ ) for infant immunisation .


We aimed to assess the immunogenicity and safety of Vi-CRM@ in participants of various ages in endemic countries in south and southeast Asia .


We did two randomised , observer-blind , age de-escalation , phase @ trials at two sites in Pakistan and India ( study A ) , and at one site in the Philippines ( study B ) , between March @ , @ , and Aug @ , @ .


Adults aged @-@ years , children aged @-@ months , older infants aged @-@ months , and infants aged @-@ weeks were randomly assigned ( @:@ ) with a computer-generated randomisation list ( block size of four ) to receive either @ g Vi-CRM@ or @ g Vi-polysaccharide vaccine ( or @-valent pneumococcal conjugate vaccine in children younger than @ years ) .


Both infant populations received Vi-CRM@ concomitantly with vaccines of the Expanded Programme on Immunization ( EPI ) , according to WHO schedule .


With the exception of designated study site personnel responsible for vaccine preparation , study investigators , those assessing outcomes , and data analysts were masked to treatment allocation .


We specified no a-priori null hypothesis for the immunogenicity or safety objectives and all analyses were descriptive .


Analyses were by modified intention-to-treat .


These studies are registered with ClinicalTrials.gov , numbers NCT@ and NCT@ .


@ participants were enrolled and vaccinated in the two trials : @ in study A ( all age groups ) and @ in study B ( children and infants only ) , of whom @ ( @ % ) were included in the modified intention-to-treat analysis .


One dose of Vi-CRM@ significantly increased concentrations of anti-Vi antibody in adults ( from @ U/mL -LSB- @ % CI @-@ -RSB- to @ U/mL -LSB- @-@ -RSB- ) , children ( @ U/mL -LSB- @-@ -RSB- to @ U/mL -LSB- @-@ -RSB- ) , and older infants ( @ U/mL -LSB- @-@ -RSB- to @ U/mL -LSB- @-@ -RSB- ) .


However , in children and older infants , a second dose of conjugate vaccine had no incremental effect on antibody titres and , at all ages , concentrations of antibodies increased substantially @ months after vaccination ( from @ U/mL -LSB- @-@ -RSB- to @ U/mL -LSB- @-@ -RSB- in adults , from @ U/mL -LSB- @-@ -RSB- to @ U/mL -LSB- @-@ -RSB- in children , and from @ U/mL -LSB- @-@ -RSB- to @ U/mL -LSB- @-@ -RSB- in older infants ) .


Immune response in infants aged @-@ weeks was lower than that in older participants and , @ months after third vaccination , antibody concentrations were significantly higher than pre-vaccination concentrations in Filipino ( @ U/mL -LSB- @-@ -RSB- vs @ U/mL -LSB- @-@ @ -RSB- ) , but not Pakistani ( @ U/mL -LSB- @-@ @ -RSB- vs @ U/mL -LSB- @-@ @ -RSB- ) , infants .


Vi-CRM@ was safe and well tolerated and did not induce any significant interference with EPI vaccines .


No deaths or vaccine-related serious adverse events were reported throughout the studies .


Vi-CRM@ is safe and immunogenic in endemic populations of all ages .


Given at @ months of age , concomitantly with measles vaccine , Vi-CRM@ shows a promise for potential inclusion in EPI schedules of countries endemic for typhoid .


An apparent absence of booster response and a reduction in antibody titres @ months after immunisation should be further investigated , but data show that an immunogenic typhoid vaccine can be safely delivered to infants during EPI visits recommended by WHO .


Steady-state visual evoked potentials ( SSVEPs ) are widely used for brain-computer interfaces .


However , users experience fatigue due to exposure to flickering stimuli .


High-frequency stimulation has been proposed to reduce this problem .


We adapt frequency-modulated ( FM ) stimulation from the auditory domain , where it is commonly used to evoke steady-state responses , and compare the EEG as well as behavioral flicker perceptibility ratings .


We evoke SSVEPs with a green light-emitting diode ( LED ) driven by FM signals .


FM-SSVEPs with different carrier and modulation frequencies can reliably be evoked with spectral peaks at the lower FM sideband .


Subjective perceptibility ratings decrease with increasing FM carrier frequencies , while the peak amplitude and signal-to-noise ratio ( SNR ) remain the same .


There are neither amplitude nor SNR differences between SSVEPs evoked rectangularly , sinusoidally or via FM .


Perceptibility ratings were lower for FM-SSVEPs with carrier frequencies of @Hz and above than for sinusoidally evoked SSVEPs .


FM-SSVEPs seem to be beneficial for BCI usage .


Reduced flicker perceptibility in FM-SSVEPs suggests reduced fatigue , which leads to an enhanced user experience and performance .


This @-week , placebo-controlled , double-blind , randomized study ( NCT@ ) investigated efficacy and safety of certolizumab pegol ( CZP ) in Japanese rheumatoid arthritis ( RA ) patients in whom methotrexate ( MTX ) can not be administered .


A total of @ patients were randomized to subcutaneous CZP @ mg ( induction dosing : @ mg at Weeks @ , @ and @ ) or placebo every @ weeks .


ACR@ responses with CZP were rapid and significant versus placebo at Week @ , sustained to Week @ ( @ % vs. @ % ) and Week @ ( @ % vs. @ % ) .


Week @-modified Total Sharp Score ( mTSS ) change from baseline ( CFB ) was @ ( CZP ) versus @ ( placebo ) .


CZP treatment was associated with higher Week @ ACR@ responses versus placebo ( with non-MTX disease modifying antirheumatic drugs -LSB- DMARDs -RSB- , @ % vs. @ % ; without -LSB- monotherapy -RSB- , @ % vs. @ % ) and inhibition of radiographic progression at Week @ ( mTSS CFB ; with non-MTX DMARDs , @ vs. @ ; monotherapy , @ vs. @ ) .


Incidences of serious adverse events were @ % ( CZP ) and @ % ( placebo ) ; one CZP patient died of dissecting aortic aneurysm .


CZP treatment with and without non-MTX DMARDs in Japanese patients in whom MTX can not be administered resulted in rapid , sustained reductions in RA signs and symptoms .


Notably , CZP monotherapy showed significant inhibition of radiographic progression .


To investigate the effects of a physiotherapy protocol on patients with pleural effusion .


Randomized controlled trial .


University hospital .


A total of @ consecutive inpatients with a medical diagnosis of pleural effusion .


Patients were randomly allocated to a control group receiving standard treatment ( medical treatment and drainage ) or an intervention group treated with physiotherapy added to standard treatment .


The physiotherapy programme included deep breathing exercises , mobilizations and incentive spirometry .


Spirometric predicted values and chest radiographs were measured before treatment and at discharge and the length of hospital stay was recorded .


Assessors were blinded to the intervention .


A comparative analysis showed a significant improvement of spirometric parameters in the intervention group ; pre-to-post hospitalization predicted values showed significant changes in vital capacity ( @ @ % to @ @ % , P < @ ) , forced expiratory volume in first second ( @ @ % to @ @ % , P < @ ) and forced expiratory flow at @-@ % ( @ @ % to @ @ % , P = @ ) compared to the control group that showed no significant changes across treatment .


The radiographic findings showed better scores on the affected side of the thorax at discharge in the physiotherapy group .


Length of hospital stay was also significantly ( P = @ ) shorter in the intervention group ( @ @ days ) compared to the control group ( @ @ days ) .


A physiotherapy programme added to standard treatment improves the spirometric parameters and the radiological findings and reduces the hospital stay in patients with a pleural effusion .


Geriatric evaluation and management has become standard care for community dwelling older adults following an acute admission to hospital .


It is unclear whether this approach is beneficial for the frailest older adults living in permanent residential care .


This study was undertaken to evaluate ( @ ) the feasibility and consumer satisfaction with a geriatrician-led supported discharge service for older adults living in residential care facilities ( RCF ) and ( @ ) its impact on the uptake of Advanced Care Planning ( ACP ) and acute health care service utilisation .


In @-@ a randomised controlled trial was conducted in Melbourne , Australia comparing the geriatrician-led outreach service to usual care for RCF residents .


Patients were recruited during their acute hospital stay and followed up at the RCF for six months .


The intervention group received a post-discharge home visit within @ hours , at which a comprehensive geriatric assessment was performed and a care plan developed .


Participants and their families were also offered further meetings to discuss ACPs and document Advanced Directives ( AD ) .


Additional reviews were made available for assessment and management of intercurrent illness within the RCF .


Consumer satisfaction was surveyed using a postal questionnaire .


The study included @ participants ( @ intervention and @ controls ) with comparable baseline characteristics .


The service was well received by consumers demonstrated by higher satisfaction with care in the intervention group compared to controls ( @ % versus @ % , p = @ ) .


AD were completed by @ % of participants/proxy decision makers in the intervention group compared to @ % of RCF residents prior to service commencement .


At six months there was a significant reduction in outpatient visits ( intervention @ ( @ % ) versus controls @ ( @ % ) , ( p < @ ) , but no difference in readmissions rates ( @ % intervention versus @ % control , p = @ ) .


There was a trend towards reduced hospital bed-day utilisation ( intervention @ versus controls @ days ) .


It is feasible to provide a supported discharge service that includes geriatrician assessment and care planning within a RCF .


By expanding the service there is the potential for acute health care cost savings by decreasing the demand for outpatient consultation and further reducing acute care bed-days .


It is unclear whether mobile-bearing ( MB ) total knee arthroplasties reduce the risk of tibial component loosening compared to fixed-bearing ( FB ) designs .


This randomized study investigated implant migration , periprosthetic bone mineral density ( BMD ) , and patient-reported outcomes ( Oxford knee score ) - all at @ years-for the P.F.C. Sigma Cruciate Retaining total knee arthroplasty .


@ osteoarthritis patients were allocated to either FB or MB tibial articulation .


At @ years , the mean total translation ( implant migration ) was higher for the FB implant ( @ mm , SD @ ) than for the MB implant ( @ mm , SD @ ) ( p = @ ) .


BMD decreased between baseline and @-year follow-up .


At @-year follow-up , BMD was close to the baseline level .


The knee scores of both groups improved equally well .


The FB tibial implant migrated more than the MB , but this was not clinically significant .


The mobile polyethylene presumably partly absorbs the force transmitted to the metal tibial tray , thereby reducing micromotion .


Shoulder pain is a very common presentation in primary care .


Evidence of benefit for subacromial corticosteroid injection is inconclusive and confined largely to studies with short follow-up .


We plan a large , definitive , primary-care-based trial to determine efficacy and safety in patients with rotator cuff tendinopathy , and conducted a pilot trial to explore feasibility .


Six general practitioners ( GPs ) from Oxfordshire , UK underwent update training in assessing painful shoulders and injecting the subacromial space .


Each then recruited patients aged @ to @ years from primary care complaining of shoulder pain lasting no more than @ months .


Eligible participants were randomized to receive either methylprednisolone acetate @ mg with lidocaine @ % ( total volume @ ml ) , or lidocaine @ % alone ( total volume @ ml ) , injected into the subacromial space .


The participants were blinded to treatment allocation .


Feasibility outcomes were rates of recruitment , withdrawal , adherence to the protocol , completeness of follow-up , and success of patient masking .


Clinical outcomes were the Oxford Shoulder Score ( OSS ) at baseline and at @ and @ weeks , and responses to three satisfaction questions at @ , @ and @ weeks .


Outcome data were collected by postal questionnaires .


A total of @ participants were randomized ( @ % of the target @ participants ) over @ weeks giving an overall recruitment rate of @ participants per week .


Rates of follow-up were maintained to a high level for the full @ weeks .


Four participants requested a ` rescue ' corticosteroid injection but no patients withdrew .


The trial GPs gave high scores for their confidence that the patient had remained blinded to treatment allocation during the procedure .


The OSS at @ and @ weeks and the responses to the satisfaction questions are reported .


It is feasible to recruit participants with shoulder pain in the primary care setting for a blinded , randomized trial of corticosteroid injection .


Online randomization of participants from the practice is also feasible , and postal questionnaires provide an effective means of gathering outcome data in this area of study .


The lessons learned from this pilot will usefully inform the design of a large , definitive efficacy trial in primary care .


To explore the cross-sectional and longitudinal relationships between fractional liver fat content , liver volume , and total liver fat burden .


In @ adults with non-alcoholic steatohepatitis participating in a clinical trial , liver volume was estimated by segmentation of magnitude-based low-flip-angle multiecho GRE images .


The liver mean proton density fat fraction ( PDFF ) was calculated .


The total liver fat index ( TLFI ) was estimated as the product of liver mean PDFF and liver volume .


Linear regression analyses were performed .


Cross-sectional analyses revealed statistically significant relationships between TLFI and liver mean PDFF ( R @ = @ baseline/@ @ follow-up , P < @ baseline/P < @ follow-up ) , and between TLFI and liver volume ( R @ = @ / @ , P < @ / < @ ) .


Longitudinal analyses revealed statistically significant relationships between liver volume change and liver mean PDFF change ( R @ = @ , P < @ ) , between TLFI change and liver mean PDFF change ( R @ = @ , P < @ ) , and between TLFI change and liver volume change ( R @ = @ , P < @ ) .


Liver segmentation in combination with MRI-based PDFF estimation may be used to monitor liver volume , liver mean PDFF , and TLFI in a clinical trial .


Data suggest that the amygdala and hippocampus contribute to cocaine seeking and use , particularly following exposure to cocaine-related cues and contexts .


Furthermore , indices of pre-treatment cocaine-use severity have been shown to correlate with treatment outcome in cocaine-dependent patients .


The aim of this study was to assess the relationships between amygdalar and hippocampal volumes and cocaine use before and during treatment .


High-resolution magnetic-resonance brain images were obtained from @ cocaine-dependent patients prior to treatment and @ healthy comparison individuals .


Automated segmentation of the amygdala and hippocampus images was performed in FreeSurfer .


Cocaine-dependent patients subsequently received behavioral therapy alone or combined with contingency management as part of a treatment trial , and cocaine-use indices ( self-report , urine toxicology ) were collected .


Comparison participants and cocaine-dependent patients did not show significant difference in amygdalar and hippocampal volumes at pre-treatment .


Within the patient group , greater hippocampal volumes were correlated with more days of cocaine use before treatment and with poorer treatment outcome as indexed by shorter durations of continuous abstinence from cocaine and lower percentages of cocaine-negative urine samples during treatment .


Mediation analysis indicated that pre-treatment hippocampal volumes mediated the relationships between pre-treatment cocaine use and treatment outcomes .


The finding of a significant correlation between hippocampal volume and pre-treatment cocaine-use severity and treatment response suggests that hippocampal volume should be considered when developing individualized treatments for cocaine dependence .


Recent prospective studies have shown that the sequential therapy has not achieved the target Helicobacter pylori eradication rate of > @ % in Korea .


The aim of this study was to therefore assess the efficacy of the hybrid therapy as a first-line treatment for H.pylori eradication in a prospective trial .


From December @ to August @ , @ patients with confirmed H.pylori infections received either the @-day hybrid therapy or the @-day sequential therapy .


Eradication outcomes were evaluated using a @C-urea breath test at least @ weeks after treatment cessation .


A total of @ patients ( @ receiving hybrid treatment and @ receiving sequential treatment ) completed the study .


The eradication rates of the hybrid and sequential therapy groups were @ % ( @/@ ; @ % confidence interval -LSB- CI -RSB- = @-@ @ % ) and @ % ( @/@ ; @ % CI = @-@ @ % ) , respectively , by intention-to-treat analysis ( P = @ ) .


By per protocol analysis , eradication rates were @ % ( @/@ ; @ % CI = @-@ @ % ) and @ % ( @/@ ; @ % CI = @-@ @ % ; P = @ ) , respectively .


There were no significant intergroup differences in treatment compliance or discontinuation induced by severe side effects .


The hybrid therapy achieved acceptable eradication rate ( @ % ) , but not statistically significantly higher rates than the sequential therapy ( @ % ) .


Further studies are therefore needed to identify first-line treatments with even better eradication rates in the Korean population .


The purpose of this study was to quantify the time required for transvaginal cervical length measurements during a second-trimester anatomy scan and to evaluate patient attitudes regarding cervical length assessment .


Consenting women were randomly assigned to one of the following : ( @ ) standard arm-cervix visualized , no prespecified cervical length measurement ; ( @ ) sequential arm-@ transabdominal cervical length measurements obtained , transvaginal sonography performed if images were inadequate or if any measurement was @ cm or less ; and ( @ ) screening transvaginal sonography arm-@ transvaginal cervical length measurements obtained .


Times were recorded for the entire examination and cervical length evaluation .


Participants completed a questionnaire at the end of their visits .


Sixty of @ eligible women enrolled .


Demographic characteristics were similar across groups except for body mass index , which was greater in the sequential arm than the screening arm ( mean SD , @ @ versus @ @ kg/m ( @ ) ; P = @ ) .


There were no differences in total examination times between the @ arms ( @ @ versus @ @ versus @ @ minutes ; P = @ ) .


There were no differences across groups in participant attitudes regarding examination discomfort or embarrassment .


Performing screening transvaginal sonography to measure cervical length did not have a statistically significant impact on the amount of time for completion of the entire examination .


Participants had positive responses regarding cervical length assessment by transabdominal and transvaginal sonography .


The objective of the study was to evaluate the efficacy of intravaginal application of @ % @-fluorouracil ( @-FU ) for the treatment of cervical intraepithelial neoplasia ( CIN ) @ in women .


Women aged @-@ years with CIN @ were recruited for this randomized controlled trial of observation vs treatment with intravaginal @-FU .


Women in the observation group returned in @ months for a Papanicolaou smear , colposcopy , and a human papillomavirus ( HPV ) deoxyribonucleic acid test .


Women in the @-FU group were treated with intravaginal @-FU once every @ weeks for a total of @ weeks and were similarly evaluated at @ months .


All women who had a baseline visit were included in the intention-to-treat analysis .


Values of P < @ were considered statistically significant .


Between August @ and June @ , @ women were randomized and had a baseline visit for intervention ( n = @ ) vs observation ( n = @ ) .


Of women who had cervical biopsy results at @ months , regression of disease was demonstrated in @ % of women in the @-FU group ( @ of @ ) and @ % of women in the observation group ( @ of @ ) .


Under the intention-to-treat analysis , a relative risk for cervical disease regression of @ ( @ % confidence interval -LSB- CI -RSB- , @-@ @ ) was found between the @-FU and observation arms ( P = @ ) .


When the cervical biopsy , Papanicolaou smear , and HPV results were combined for the @ month follow-up visit , @ % of the @-FU group ( @ of @ ) had a documented normal biopsy , normal Papanicolaou smear , and negative HPV test compared with @ % in the observation group ( @ of @ ) ( relative risk , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


There were no moderate or severe side effects in the intervention group .


Topical @-FU appears to be an effective medical therapy for CIN @ in young women .


@-FU is readily available and may be considered as an off-label treatment option for young women with CIN @ who are interested in the treatment of disease but want to avoid excisional procedures .


Pain is expected during noninvasive skin tightening and can be anxiety provoking , especially for those who have not had prior treatments .


To compare pain reported by patients nave to nonablative skin tightening energy devices with those who were not naive .


The non-nave group at least three nonablative laser procedures or one nonablative skin tightening procedure , and the nave group no previous treatments .


Four sites at each of two anatomic locations ( periorbital and midface or cheek ) were treated in each subject with needle prick , pulsed dye laser , radiofrequency , and ultrasound with the order of the interventions randomized .


All interventions except ultrasound were also applied to three abdominal sites .


The difference in mean pain scores between nave and nonnave subjects were averaged over the anatomic sites .


Ten nave and @ non-nave subjects completed study procedures .


Mean pain scores ranged from @ to @ .


The mean for all nave conditions was @ @ , vs @ @ for non-nave conditions .


There was no overall difference according to group , device , or anatomic area .


There was no significant difference in pain between nave and non-nave subjects undergoing cutaneous energy treatments .


Individual devices may elicit more pain at specific anatomic locations .


The purpose of this study was to investigate the effects of @ weeks of custom foot orthotics on pain , disability , recurrence of spinal fixation , and muscle dysfunction in adult low back pain patients receiving limited chiropractic care .


Adult volunteers with low back pain of greater than or equal to @ month 's duration were randomized to receive custom orthotics ( group A ) or a flat insole sham ( group B ) with limited chiropractic care in @ visits over @ weeks .


Primary outcome measures are as follows : Quadruple Numerical Pain Rating Scale ( for back ) , the Roland-Morris Disability Questionnaire , the number of muscles grade @ or lower on manual muscle testing , and the number of spinal fixations detected by motion palpation and vertebral challenge at intake ( B@ ) , @ weeks later before treatment began and orthotic use was initiated ( B@ ) and before each subsequent treatment at approximately days @ , @ , @ , and @ after B@ .


Secondary outcome measures are correlations of all primary outcomes .


Both groups improved on all Numerical Pain Rating Scale , Roland-Morris Disability Questionnaire , and the number of muscles from intake ( B@ ) to final visit .


Only group B yielded significant improvements in the number of spinal fixations .


No outcome measures showed statistical difference between groups at any time point ; however , those who wore custom orthotics longer each day showed trends toward greater improvements in some outcome measures .


Both groups improved with chiropractic care including spinal manipulation ; however , there were no statistical differences shown between sham and custom orthotic groups .


Future studies should formally measure the time that orthotics or shams are worn in a weight-bearing capacity each day .


We aimed to test the effectiveness of checklists for emergency procedures on medical staff performance in intensive care crises .


This is a prospective single-center randomized trial in a high-fidelity simulation center modeling an intensive care unit ( ICU ) in a tertiary care hospital in Germany .


Teams consisted of @ ICU resident and @ ICU nurses ( in total , n = @ ) .


All completed @ crisis scenarios , in which they were randomized to use checklists or to perform without any aid .


In @ of the scenarios , checklists could be used immediately ( type @ scenarios ) ; and for the remaining , some further steps , for example , confirming diagnosis , were required first ( type @ scenarios ) .


Outcome measurements were number of predefined items and time to completion of more than @ % and more than @ % of steps , respectively .


When using checklists , participants initiated items faster and more completely according to appropriate treatment guidelines ( @ vs @ items with and without checklists , P < @ ) .


Benefit of checklists was better in type @ scenarios than in type @ scenarios ( @ vs @ additional item , P < @ ) .


In type @ scenarios , time to complete @ % and @ % of items was faster with the use of checklists ( P < @ ) .


Use of checklists in ICU crises has a benefit on the completion of critical treatment steps .


Within the type @ scenarios , items were fulfilled faster with checklists .


The implementation of checklists for intensive care crises is a promising approach that may improve patients ' care .


Rapid reversal of vitamin K antagonist ( VKA ) - induced anticoagulation is often necessary for patients needing urgent surgical or invasive procedures .


The optimum means of VKA reversal has not been established in comparative clinical trials .


We compared the efficacy and safety of four-factor prothrombin complex concentrate ( @F-PCC ) with that of plasma in VKA-treated patients needing urgent surgical or invasive procedures .


In a multicentre , open-label , phase @b randomised trial we enrolled patients aged @ years or older needing rapid VKA reversal before an urgent surgical or invasive procedure .


We randomly assigned patients in a @:@ ratio to receive vitamin K concomitant with a single dose of either @F-PCC ( Beriplex/Kcentra/Confidex ; CSL Behring , Marburg , Germany ) or plasma , with dosing based on international normalised ratio ( INR ) and weight .


The primary endpoint was effective haemostasis , and the co-primary endpoint was rapid INR reduction ( @ at @ h after infusion end ) .