The aim of this report is to describe the challenges , successes and patterns of enrolment in the Strategic Timing of AntiRetroviral Treatment ( START ) study .


START is a collaboration of many partners with central coordination provided by the protocol team , the statistical and data management centre ( SDMC ) , the International Network for Strategic Initiatives in Global HIV Trials ( INSIGHT ) network leadership , international coordinating centres and site coordinating centres .


The SDMC prepared reports on study accrual , baseline characteristics and site performance that allowed monitoring of enrolment and data quality and helped to ensure the successful enrolment of this large international trial .


We describe the pattern of enrolment and challenges faced during the enrolment period of the trial .


An initial pilot phase began in April @ and established feasibility of accrual at @ sites .


In August @ , funding approval for an expanded definitive phase led to the successful accrual of @ participants from @ sites in @ countries by December @ .


Challenges to accrual included regulatory delays ( e.g. national/local ethics approval and drug importation approval ) and logistical obstacles ( e.g. execution of contracts with pharmaceutical companies , setting up of a central drug repository and translation of participant materials ) .


The personal engagement of investigators , strong central study coordination , and frequent and transparent communication with site investigators , community members and participants were key contributing factors to this success .


Accrual into START was completed in a timely fashion despite multiple challenges .


This success was attributable to the efforts of site investigators committed to maintaining study equipoise , transparent and responsive study coordination , and community involvement in problem-solving .


An emerging body of evidence supports a role for dysfunctional purinergic neurotransmission in mood disorders .


Adenosine agonists have been shown to have properties similar to those of dopamine antagonists ; there is a well-characterized interaction between adenosine and dopamine receptors in the ventral striatum , and increasing adenosinergic transmission has been demonstrated to reduce the affinity of dopamine agonists for dopamine receptors .


Allopurinol increases adenosine levels in the brain , and hence is hypothesized to reduce the symptoms of mania .


Two randomized , placebo-controlled trials administering add-on allopurinol to manic patients showed significantly greater improvements in Young Mania Rating Scale ( YMRS ) scores for drug compared to placebo , while a more recent , relatively small , add-on study showed negative results .


Based on these data , our objective was to examine the efficacy of allopurinol as add-on treatment to mood stabilizers and/or antipsychotic agents in manic patients with bipolar disorder .


We performed a large , well-powered , multicenter , six-week , randomized , placebo-controlled trial of allopurinol added to mood stabilizers and/or antipsychotic agents in @ patients with bipolar disorder in an acute manic episode .


Both groups showed improvement on the YMRS ( effect size of @ for placebo and @ for allopurinol ) , with no difference observed between groups on YMRS scores ( t = @ , p = @ ) .


There was no difference in the proportion of patients who responded to treatment ( defined as showing at least @ % improvement in YMRS score ) between the two groups ( p = @ ) , or in dropout rates ( p = @ ) .


None of our patients received lithium .


However , the side effects of lithium and its narrow therapeutic index made the use of lithium less common and , therefore , our study results reflect common current clinical practice .


In the present study , we used a variety of antipsychotic and/or mood stabilizing treatments , to which we added allopurinol ; one might hypothesize that add-on allopurinol has a different effect in combination with different antipsychotic agents or mood stabilizers .


The findings of this large , well-powered study do not support add-on allopurinol as a treatment for acute mania .


This study did not test the efficacy of allopurinol as monotherapy .


The objective was to investigate the potential protective effects of two conditioning methods , on myocardial ischemic and reperfusion injury in relation to cardiac surgery .


Totally @ patients were randomly assigned to either a control group ( n = @ ) , a remote ischemic preconditioning ( RIPC ) group ( n = @ ) or a glucagon-like peptide-@ ( GLP-@ ) analogue group ( n = @ ) .


The RIPC protocol consisted of three cycles of upper limb ischemia .


The GLP-@ analogue protocol consisted of intravenous infusion with exenatide .


The primary endpoint was postoperative cardiac enzyme release .


The other secondary endpoints were metabolic parameters related to myocardial ischemia , measured using microdialysis technique , as well as other operative - and postoperative data .


Postoperative cardiac enzyme release indicated a possible beneficial effect of the interventions , but the difference did not reach statistical significance .


RIPC showed a trend toward lower levels ( p = @ ) .


We managed to establish a functional myocardial microdialysis model , but we were unable to demonstrate clear protective effects .


We were in this prospective randomized proof-of-concept trial , unable to show distinct protective effects of the studied conditioning methods .


However , this trial can hopefully contribute to generate a productive discussion concerning limitations and future use of cardiac conditioning as well as microdialysis technique .


Laparoscopic cholecystectomy performed during low intraabdominal pressure ( < @ mm Hg ) is associated with significantly less postoperative pain than standard pressure ( @ mm Hg ) .


The impact on surgical space conditions and safety of operating at lower pressures has not been adequately described , but deep neuromuscular blockade may be beneficial .


We investigated if deep muscle relaxation would be associated with a higher proportion of procedures with `` optimal '' surgical space conditions compared with moderate relaxation during low-pressure ( @ mm Hg ) laparoscopic cholecystectomy .


In this assessor-blinded study , @ patients undergoing elective laparoscopic cholecystectomy were administered rocuronium for neuromuscular blockade and randomized to either deep neuromuscular blockade ( rocuronium bolus plus infusion maintaining a posttetanic count @-@ ) or moderate neuromuscular blockade ( rocuronium repeat bolus only for inadequate surgical conditions with spontaneous recovery of neuromuscular function ) .


Patients received anesthesia with propofol , remifentanil , and rocuronium .


The primary outcome was the proportion of procedures with optimal surgical space conditions ( assessed by the surgeon as @ on a @-point scale ) .


Secondary outcomes included the proportion of procedures completed at pneumoperitoneum @ mm Hg and surgical space conditions on dissection of the gallbladder ( numeric rating scale @-@ ; @ = optimal surgical space conditions ; @ = unacceptable surgical space conditions ) .


Optimal surgical space conditions during the entire procedure were observed in @ of @ patients allocated to deep neuromuscular blockade and in @ of @ patients allocated to moderate blockade ( P = @ ) with an absolute difference of @ % between the groups ( @ % confidence interval , @ % -@ % ) .


Laparoscopic cholecystectomy was completed at pneumoperitoneum @ mm Hg in @ of @ and @ of @ patients in the deep and moderate group , respectively ( @ % confidence interval , -@ % to @ % ; P = @ ) .


Surgical space conditions during dissection of the gallbladder assessed by use of the numeric rating scale were @ ( @-@ ) ( median -LSB- @ % -@ % range -RSB- ) in the deep neuromuscular blockade group and @ ( @-@ ) in the moderate group ( P = @ ; Wilcoxon-Mann-Whitney odds , @ ; @ % confidence interval , @-@ @ ) .


No operations were converted to laparotomy .


Deep neuromuscular blockade was associated with surgical space conditions that were marginally better than with moderate muscle relaxation during low-pressure laparoscopic cholecystectomy .


This study aimed to ascertain whether training-induced muscle hypertrophy is accompanied by an increase in the aponeurosis width , and to infer its impact on the training-induced increase in the pennation angle .


Eleven young men completed a resistance training program of unilateral knee extensions for @ weeks .


Before and after training , anatomical cross-sectional area ( ACSA ) of the vastus lateralis and its distal aponeurosis width in the transverse plane were measured with magnetic resonance imaging .


The pennation angle and fascicle length were also determined with ultrasonography at the midbelly of the muscle .


The effect of change in aponeurosis width on the magnitude of training-induced increase in pennation angle was estimated by using a parallelepipedon model .


After the training , there were significant increases in ACSA ( @ @ % ) , pennation angle ( @ @ % ) and aponeurosis width ( @ @ % ) , whereas no significant change was found in the fascicle length .


The model simulation shows that the increase in aponeurosis width by @ % reduces the magnitude of increase in pennation angle by only @ .


These results indicate that ( @ ) the aponeurosis width of the vastus lateralis increases after @ weeks of resistance training and ( @ ) the increase in the aponeurosis width accompanying muscle hypertrophy by the amount of ~ @ % does not substantially affect the increase in pennation angle .


Physical rehabilitation programs for kidney transplant recipients are not routinely personalized to patients ' physical and emotional health , which could result in a potentially limited health impact , shorter-term participation , and an overall low success rate .


We conducted an internal review board-approved randomized prospective study involving a @-month supervised multidisciplinary rehabilitation program ( GH method ) initiated after kidney transplantation in obese recipients ( body mass index > @ ) .


The new method incorporates @ major components : physical exercise , behavioral interventions , and nutritional guidance .


We compared @ patients who underwent supervised rehabilitation with @ patients who underwent standard care .


Patients were followed up after the start of the intervention , and multiple assessments were performed .


The adherence to training and follow-up was @ % in the intervention group , compared with @ % at @ months in the control group .


There was a trend for a higher glomerular filtration rate in the intervention group compared with the control group ( @ @ mL/min/@ @ m ( @ ) vs @ @ mL/min/@ @ m ( @ ) , P = @ ) .


The quality of life ( SF-@ ) mean score improved more in the intervention group compared with the control group ( @ @ vs @ @ , P = @ ) .


There was a significantly higher employment rate in the intervention group , @ % at @ months compared with @ % in the control group ( P = @ ) .


Our preliminary results suggest that this comprehensive approach to physical rehabilitation can improve adherence , kidney function , quality of life , and employment rate for obese patients after kidney transplantation .


In cystic fibrosis ( CF ) , the paranasal sinuses are sites of first and persistent colonization by pathogens such as Pseudomonas aeruginosa .


Pathogens subsequently descend to the lower airways , with P. aeruginosa remaining the primary cause of premature death in patients with the inherited disease .


Unlike conventional aerosols , vibrating aerosols applied with the PARI Sinus nebulizer deposit drugs into the paranasal sinuses .


This trial assessed the effects of vibrating sinonasal inhalation of the antibiotic tobramycin in CF patients positive for P. aeruginosa in nasal lavage .


To evaluate the effects of sinonasal inhalation of tobramycin on P. aeruginosa quantification in nasal lavage ; and on patient quality of life , measured with the Sino-Nasal Outcome Test ( SNOT-@ ) , and otologic and renal safety and tolerability .


Patients were randomized to inhalation of tobramycin ( @ mg/@ mL ) or placebo ( @ mL isotonic saline ) once daily ( @ minutes/nostril ) with the PARI Sinus nebulizer over @ days , with all patients eligible for a subsequent course of open-label inhalation of tobramycin for @ days .


Nasal lavage was obtained before starting and @ days after the end of each treatment period by rinsing each nostril with @ mL of isotonic saline .


Nine patients participated , six initially receiving tobramycin and three placebo .


Sinonasal inhalation was well tolerated , with serum tobramycin < @ mg/L and stable creatinine .


P. aeruginosa quantity decreased in four of six ( @ % ) patients given tobramycin , compared with zero of three given placebo ( non-significant ) .


SNOT-@ scores were significantly lower in the tobramycin than in the placebo group ( P = @ ) .


Sinonasal inhalation of vibrating antibiotic aerosols appears promising for reducing pathogen colonization of paranasal sinuses and for control of symptoms in patients with CF.


The orodispersible house dust mite ( HDM ) sublingual immunotherapy ( SLIT ) - tablet ( ALK , Denmark ) is being developed for the treatment of HDM respiratory allergic disease .


The objective of the @ phase I trials was to investigate tolerability and the acceptable dose range of HDM SLIT-tablet treatment in adults and children with HDM respiratory allergic disease .


The trials were randomized , multiple-dose , dose-escalation , double-blind , placebo-controlled phase I trials including patients with HDM-induced asthma , with or without rhinoconjunctivitis .


Both trials were registered in EudraCT ( Trial @ : @-@-@ ; Trial @ : @-@-@ ) .


Trial @ included @ adults ( @-@ years ) and trial @ included @ children ( @-@ years ) .


Both trials included @ dose groups that were randomized @:@ to active treatment or placebo once daily for @ days .


Adverse events ( AEs ) were coded in MedDRA ( version @ or later ) .


Immunological variables included specific IgE and IgE-blocking factor .


No serious AEs were reported .


In trial @ ( maximum dose , @ development units -LSB- DU -RSB- ) , @ patient in the @ DU group discontinued due to AEs .


The entire @ DU group was discontinued as @ patient had a severe adverse reaction .


In trial @ ( maximum dose , @ DU ) , no patients discontinued prematurely .


The most frequently reported AEs were mild application-site related events .


The total number of events was dose-related within each trial .


HDM SLIT-tablet treatment induced changes in immunological parameters in a dose-dependent manner .


These trials demonstrate that doses up to @ DU of HDM SLIT-tablet were tolerated in the selected populations , and thus are suitable for further clinical investigations in adults and children with HDM respiratory allergic disease .


To investigate the feasibility and safety of pH capsule to monitor pH in patients with gastroesophageal reflux disease ( GERD ) .


Ninety-one patients with symptoms suggestive of GERD were enrolled in this study , @ of whom were randomized to the pH capsule group ; the remaining @ patients used the conventional catheter and pH capsule simultaneously .


The pH data and traces were recorded via automatic analysis , and capsule detachment was assessed using X-ray images .


All of the patients were required to complete a questionnaire regarding tolerance with the capsule .


The capsules were successfully attached on the first attempt , and no early detachment of the capsules was observed .


Compared to the @-h pH data recorded with the conventional catheter , the data collected with the pH capsule showed no significant differences in @-h esophageal acid exposure .


The measurements of esophageal acid exposure over @ h collected with the two devices showed a significant correlation ( r ( @ ) = @ , P < @ ) .


Capsule detachment occurred spontaneously in @ patients , and @ capsules required endoscopic removal due to chest pain .


The capsule was associated with less interference with daily activity .


The wireless pH capsule provides a feasible and safe method for monitoring gastroesophageal reflux and therefore may serve as an important tool for diagnosing GERD .


Male circumcision is a primary HIV-@ prevention intervention for men , but whether the procedure reduces the risk of syphilis among men and their female partners is uncertain .


We aimed to assess whether male circumcision was associated with incident syphilis in men and in their female partners .


In this large prospective cohort study , participants were members of Kenyan and Ugandan HIV-@ serodiscordant heterosexual couples enrolled in a randomised safety and efficacy clinical trial of pre-exposure prophylaxis for HIV-@ prevention ( the Partners PrEP Study ) .


Participants attended monthly or quarterly follow-up visits for up to @ months .


Annually , syphilis serology testing was done and male circumcision status was assessed .


We used multivariate Andersen-Gill survival methods , adjusted for age , sexual behaviour , and plasma HIV RNA levels of the HIV-infected partner .


@ HIV-@ serodiscordant couples ( @ % ) with a man with HIV were followed for a median of @ years .


At enrolment , @ ( @ % ) men with HIV and @ ( @ % ) men without HIV were circumcised ; an additional @ ( @ % ) men with HIV and @ ( @ % ) men without HIV were circumcised during study follow-up .


@ incident syphilis infections were reported : @ ( @ % ) in men with HIV ( incidence @ per @ person-years ) , @ ( @ % ) in men without HIV ( @ ) , @ ( @ % ) in women with HIV ( @ ) , and @ ( @ % ) in women without HIV ( @ ) .


Male circumcision was associated with a @ % reduction in incident syphilis in men ( adjusted hazard ratio -LSB- aHR -RSB- @ , @ % CI @-@ ) including a @ % reduction in men with HIV ( @ , @-@ ) , and a non-significant reduction in incident syphilis in men without HIV ( @ , @-@ ) .


In women , circumcision of their male partners was associated with a @ % reduction in incident syphilis ( aHR @ , @ % CI @-@ ) , including a @ % reduction in women without HIV ( @ , @-@ ) and a @ % reduction in women with HIV ( @ , @-@ ) .


Male circumcision was associated with decreased risk of incident syphilis in men and women .


If confirmed , these results suggest that medical male circumcision could substantially reduce incidence of syphilis and its sequelae .


Telomere length in blood or buccal cell DNA has been associated with risk of various cancers .


Glioma can be a highly malignant brain tumor and has few known risk factors .


Genetic variants in or near RTEL@ and TERT , key components of telomere biology , are associated with glioma risk .


Therefore , we evaluated the association between relative telomere length ( RTL ) and glioma in a prospective study .


We performed a nested case-control study within the Prostate , Lung , Colorectal , and Ovarian ( PLCO ) Cancer Screening Trial .


RTL was determined by quantitative PCR on blood or buccal cell DNA obtained at least @ years prior to diagnosis from @ individuals with glioma cases .


Healthy controls ( n = @ ) were matched to cases ( @:@ ) on age , gender , smoking status , calendar year , and DNA source .


Conditional logistic regression was used to investigate the association between RTL and glioma .


As expected , RTL declined with increasing age in both cases and controls .


There was no statistically significant association between RTL and glioma overall .


An analysis stratified by gender suggested that short RTL ( @st tertile ) in males was associated with glioma ( odds ratio , -LSB- OR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- @-@ @ ) ; this association was not observed for females ( OR = @ , @ % CI @-@ @ ) .


This prospective study did not identify significant associations between RTL and glioma risk , but there may be gender-specific differences .


Larger , prospective studies are needed to evaluate these findings .


The philtral column and dimple are especially important in patients with cleft lip .


Recently , we have found that , at maximal puckering , the appearance of the philtrum worsens although the philtral column is well formed at rest .


In this study , we explore the effectiveness of the coronal muscle splitting technique in a microform cleft lip through comparative analysis of the postoperative results between the control group ( patients without coronal muscle splitting ) and the study group ( patients with coronal muscle splitting ) .


Philtral reconstruction was performed in @ patients with microform cleft lip between March @ and March @ .


The philtrum was reconstructed in @ patients using the coronal muscle splitting technique and in the other @ patients without this technique .


The convexity of the philtral column and the dimpling of the philtrum were evaluated at rest and at maximal puckering through digital photographs and videos taken preoperatively and postoperatively .


In addition , we compared the postoperative results between the @ groups using the paired t-test .


Postoperative evaluation was done at @ to @ months ( mean , @ mo ) .


There was no statistically significant difference in the shape of the philtral column and the philtral dimple between the @ groups preoperatively ( P > @ ) .


Reconstruction of the philtral column in the study group rendered better results than in the control group at both rest and maximal puckering ( P < @ and P < @ ) .


Reconstruction of the philtral dimple in the study group rendered better results than in the control group at both rest and maximal puckering ( P = @ and @ ) .


The coronal muscle splitting technique offers more esthetic and functional results in the formation of the philtral column and dimple both at rest and at maximal puckering than in the control group in cases of philtral reconstruction of the microform cleft lip .


The construct of ` preparation for future learning ' ( PFL ) is understood as the ability to learn new information from available resources , relate new learning to past experiences and demonstrate innovation and flexibility in problem solving .


Preparation for future learning has been proposed as a key competence of adaptive expertise .


There is a need for educators to ensure that opportunities are provided for students to develop PFL ability and that assessments accurately measure the development of this form of competence .


The objective of this research was to compare the relative impacts of basic science instruction and clinically focused instruction on performance on a PFL assessment ( PFLA ) .


This study employed a ` double transfer ' design .


Fifty-one pre-clerkship students were randomly assigned to either basic science instruction or clinically focused instruction to learn four categories of disease .


After completing an initial assessment on the learned material , all participants received clinically focused instruction for four novel diseases and completed a PFLA .


The data from the initial assessment and the PFLA were submitted to independent-sample t-tests .


Meanstandard deviation -LSB- SD -RSB- scores on the diagnostic cases in the initial assessment were similar for participants in the basic science ( @ ) and clinical learning ( @ ) conditions .


The difference was not significant ( t -LSB- @ -RSB- = @ , p = @ , d = @ ) .


Analysis of the diagnostic cases on the PFLA revealed significantly higher meanSD scores for participants in the basic science learning condition ( @ ) compared with those in the clinical learning condition ( @ ) ( t -LSB- @ -RSB- = @ , p = @ , d = @ ) .


Our results show that the inclusion of basic science instruction enhanced the learning of novel related content .


We discuss this finding within the broader context of research on basic science instruction , development of adaptive expertise and assessment in medical education .


This study assessed whether a cycle of `` routine '' therapeutic drug monitoring ( TDM ) for imatinib dosage individualization , targeting an imatinib trough plasma concentration ( C min ) of @,@ ng/ml ( tolerance : @-@ ,@ ng/ml ) , could improve clinical outcomes in chronic myelogenous leukemia ( CML ) patients , compared with TDM use only in case of problems ( `` rescue '' TDM ) .


Imatinib concentration monitoring evaluation was a multicenter randomized controlled trial including adult patients in chronic or accelerated phase CML receiving imatinib since less than @years .


Patients were allocated @:@ to `` routine TDM '' or `` rescue TDM . ''


The primary endpoint was a combined outcome ( failure - and toxicity-free survival with continuation on imatinib ) over @-year follow-up , analyzed in intention-to-treat ( ISRCTN@ ) .


Among @ patients ( @ evaluable ) , @/@ ( @ % ) receiving `` routine TDM '' remained event-free versus @/@ ( @ % ) `` rescue TDM '' controls ( P = @ ) .


In the `` routine TDM '' arm , dosage recommendations were correctly adopted in @ patients ( median C min : @ng/ml ) , who had fewer unfavorable events ( @ % ) than the @ not receiving the advised dosage ( @ % ; P = @ ; median C min : @ng/ml ) .


This first target concentration intervention trial could not formally demonstrate a benefit of `` routine TDM '' because of small patient number and surprisingly limited prescriber 's adherence to dosage recommendations .


Favorable outcomes were , however , found in patients actually elected for target dosing .


This study thus shows first prospective indication for TDM being a useful tool to guide drug dosage and shift decisions .


The study design and analysis provide an interesting paradigm for future randomized TDM trials on targeted anticancer agents .


Computed tomography ( CT ) scans of the lumbar spine ( CTLS ) have demonstrated a higher level of accuracy than plain films and have been used to assess patients with spinal disorder when magnetic resonance imaging is not available .


Nevertheless , radiation exposure remains a serious safety concern .


Iterative reconstruction ( IR ) decreases the CT radiation dose for diagnostic imaging .


However , the feasibility of using IR in CTLS is unclear .


To evaluate the imaging quality and diagnostic reliability of CTLS with IR .


A prospective study .


All patients from outpatient departments who suffered from spinal disorders and were referred for CTLS .


In acquired CT images , the signal-to-noise ratio ( SNR ) of the dural sac ( DS ) , intervertebral disc ( IVD ) , psoas muscle ( PM ) , and L@ vertebral body , the contrast-to-noise ratio between the DS and IVD ( D-D CNR ) , and the subjective imaging qualities were compared across groups .


Interobserver agreement was evaluated with kappa values .


Patients receiving low radiation CTLS were divided into three groups .


A @ mAs tube current with @ kVp tube voltage was used with Group A and a @ mAs tube current with @ kVp tube voltage with Group B. Intended end radiation exposure was @ % less than that of the control group .


Tube modulation was active for all groups .


The images of the two low-radiation groups were reconstructed by IR ; those of the control group by filtered back-projection ( FBP ) .


The SNRs of the DS , IVD , PM , BM , and D-D CNR of Group A were not inferior to those of the control group .


All SNRs and D-D CNRs for Group B were inferior to those of the control group .


Except for that of the facet joint , all subjective imaging ratings for anatomic regions were equivalent between Groups A and B. Interobserver agreement was highest for the control group ( @-@ @ ) , followed by Group A ( @-@ @ ) and B ( @-@ @ ) .


Fifty percent tube current reduction combined with IR provides equivalent diagnostic accuracy and improved patient safety when compared with conventional CTLS .


Our results support its use as a screening tool .


With the tube modulation technique , further adjustments in weighting IR and FBP algorithms based on body mass index become unnecessary .


The clinical benefits of using icodextrin during acute peritonitis in peritoneal dialysis are uncertain .


On the premise that high glucose concentration might jeopardize the peritoneal defense during peritonitis , icodextrin administration during acute peritonitis could have the potential to improve the peritonitis outcome whilst improving ultrafiltration .


We conducted a single-center , open-label , randomized controlled trial in which @ adult continuous ambulatory peritoneal dialysis patients underwent randomization to receive either icodextrin or original glucose-based dialysis solution .


The primary outcome measure was the peritoneal dialyzate white cell count on Day @ .


Secondary outcome measures comprised the need of additional hypertonic exchanges , fluid control as denoted by changes in body weight , and the clinical outcome of peritonitis including @-day and @-day all-cause mortality .


Between icodextrin and control treatment groups , there were no statistically significant differences in the peritoneal dialyzate white cell count on day ( @ versus @/mm ( @ ) , P = @ ) .


There was neither improvement in primary cure rate ( @ versus @ % , P = @ ) , nor was there any change in @-day mortality after icodextrin use ( @ versus @ % , P = @ ) .


However , requirement of hypertonic dialysis exchange was much more frequent in the control group than in those randomized to icodextrin ( @ versus @ % , P = @ ) .


Body weight did not change significantly in the icodextrin group , but body weight in the control group increased from @ @ kg at baseline to @ @ kg at Day @ ( P = @ ) and @ @ kg at Day @ ( P < @ ) .


As compared with glucose-based peritoneal dialysis solution , use of icodextrin achieved better ultrafiltration and fluid control during acute peritonitis complicating continuous ambulatory peritoneal dialysis , although we found no evidence of a worthwhile clinical benefit on peritonitis resolution .


( ClinicalTrial.gov number , NCT@ -LSB- ClinicalTrial.gov -RSB- . )


Maternal risk factors for fetal alcohol spectrum disorders ( FASD ) in Italy and Mediterranean cultures need clarification , as there are few studies and most are plagued by inaccurate reporting of antenatal alcohol use .


Maternal interviews ( n = @ ) were carried out in a population-based study of the prevalence and characteristics of FASD in the Lazio region of Italy which provided data for multivariate case control comparisons and multiple correlation models .


Case control findings from interviews seven years post-partum indicate that mothers of children with FASD are significantly more likely than randomly-selected controls or community mothers to : be shorter ; have higher body mass indexes ( BMI ) ; be married to a man with legal problems ; report more drinking three months pre-pregnancy ; engage in more current drinking and drinking alone ; and have alcohol problems in her family .


Logistic regression analysis of multiple candidate predictors of a FASD diagnosis indicates that alcohol problems in the child 's family is the most significant risk factor , making a diagnosis within the continuum of FASD @ times more likely ( @ % C.I. = @ to @ ) .


Sequential multiple regression analysis of the child 's neuropsychological performance also identifies alcohol problems in the child 's family as the only significant maternal risk variable ( p < @ ) when controlling for other potential risk factors .


Underreporting of prenatal alcohol use has been demonstrated among Italian and other Mediterranean antenatal samples , and it was suspected in this sample .


Nevertheless , several significant maternal risk factors for FASD have been identified .


To compare the efficacy and safety of new insulin glargine @ units/mL ( Gla-@ ) with glargine @ units/mL ( Gla-@ ) in people with type @ diabetes using basal insulin ( @ units/day ) plus oral antihyperglycemic drugs ( OADs ) .


EDITION @ was a multicenter , open-label , two-arm study .


Adults receiving basal insulin plus OADs were randomized to Gla-@ or Gla-@ once daily for @ months .


The primary end point was change in HbA@c .


The main secondary end point was percentage of participants with one or more nocturnal confirmed ( @ mmol/L -LSB- @ mg/dL -RSB- ) or severe hypoglycemic events from week @ to month @ .


Randomized participants ( n = @ ) had a mean ( SD ) HbAc of @ % ( @ ) and BMI of @ kg/m ( @ ) ( @ ) .


Glycemic control improved similarly with both basal insulins ; least squares mean ( SD ) reduction from baseline was -@ % ( @ ) for Gla-@ and -@ % ( @ ) for Gla-@ ( mean difference -@ % -LSB- @ % CI -@ to @ -RSB- ) , with @ % higher dose of Gla-@ .


Less nocturnal confirmed ( @ mmol/L -LSB- @ mg/dL -RSB- ) or severe hypoglycemia was observed with Gla-@ from week @ to month @ ( relative risk @ -LSB- @ % CI @-@ @ -RSB- ; P = @ ) and during the first @ weeks .


Fewer nocturnal and any time ( @ h ) hypoglycemic events were reported during the entire @-month period .


Weight gain was lower with Gla-@ than with Gla-@ ( P = @ ) .


No between-treatment differences in safety parameters were identified .


Gla-@ was as effective as Gla-@ and associated with a lower risk of hypoglycemia during the night and at any time of the day .


The combination of cyclophosphamide and glucocorticoids leads to remission in most patients with antineutrophil cytoplasm antibody ( ANCA ) - associated vasculitides .


However , even when patients receive maintenance treatment with azathioprine or methotrexate , the relapse rate remains high .


Rituximab may help to maintain remission .


Patients with newly diagnosed or relapsing granulomatosis with polyangiitis , microscopic polyangiitis , or renal-limited ANCA-associated vasculitis in complete remission after a cyclophosphamide-glucocorticoid regimen were randomly assigned to receive either @ mg of rituximab on days @ and @ and at months @ , @ , and @ after study entry or daily azathioprine until month @ .


The primary end point at month @ was the rate of major relapse ( the reappearance of disease activity or worsening , with a Birmingham Vasculitis Activity Score > @ , and involvement of one or more major organs , disease-related life-threatening events , or both ) .


The @ enrolled patients ( @ with granulomatosis with polyangiitis , @ with microscopic polyangiitis , and @ with renal-limited ANCA-associated vasculitis ) received azathioprine ( @ patients ) or rituximab ( @ patients ) .


At month @ , major relapse had occurred in @ patients in the azathioprine group ( @ % ) and in @ patients in the rituximab group ( @ % ) ( hazard ratio for relapse , @ ; @ % confidence interval , @ to @ ; P = @ ) .


The frequencies of severe adverse events were similar in the two groups .


Twenty-five patients in each group ( P = @ ) had severe adverse events ; there were @ events in the azathioprine group and @ in the rituximab group .


Eight patients in the azathioprine group and @ in the rituximab group had severe infections , and cancer developed in @ patients in the azathioprine group and @ in the rituximab group .


Two patients in the azathioprine group died ( @ from sepsis and @ from pancreatic cancer ) .


More patients with ANCA-associated vasculitides had sustained remission at month @ with rituximab than with azathioprine .


( Funded by the French Ministry of Health ; MAINRITSAN ClinicalTrials.gov number , NCT@ ; EudraCT number , @-@-@ . )


In the Prevention of Malaria and HIV disease in Tororo pediatrics trial , HIV-infected Ugandan children randomized to receive lopinavir/ritonavir ( LPV/r ) - based antiretroviral therapy ( ART ) experienced a lower incidence of malaria compared with children receiving nonnucleoside reverse transcriptase inhibitor ( NNRTI ) - based ART .


Here we present the results of the noninferiority analysis of virologic efficacy and comparison of immunologic outcomes .


ART-naive or - experienced ( HIV RNA < @ copies/mL ) children aged @ months to @ years received either LPV/r or NNRTI-based ART .


The proportion of children with virologic suppression ( HIV RNA < @ copies/mL ) at @ weeks was compared using a prespecified noninferiority margin of -@ % in per-protocol analysis .


Time to virologic failure by @ weeks , change in CD@ counts and percentages , and incidence of adverse event rates were also compared .


Of @ children enrolled , @ initiated LPV/r and @ initiated NNRTI-based ART .


At baseline , the median age was @ years ( range , @-@ @ ) , and @ ( @ % ) children were ART-naive .


The proportion of children with virologic suppression at @ weeks was @ % ( @/@ ) in the LPV/r arm vs. @ % ( @/@ ) in the NNRTI arm , a difference of @ % ( @ % confidence interval : -@ % to +@ % ) .


Time to virologic failure , CD@ changes , and the incidence of Division of AIDS grade III/IV adverse events were similar between arms .


LPV/r-based ART was not associated with worse virologic efficacy , immunologic efficacy , or adverse event rates compared with NNRTI-based ART .


Considering these results and the reduction in malaria incidence associated with LPV/r previously reported for this trial , wider use of LPV/r to treat HIV-infected African children in similar malaria-endemic settings could be considered .


The impact of the age of first Plasmodium falciparum infection on the rate of acquisition of immunity to malaria and on the immune correlates of protection has proven difficult to elucidate .


A randomized , double-blind , placebo-controlled trial using monthly chemoprophylaxis with sulphadoxine-pyrimethamine plus artesunate was conducted to modify the age of first P. falciparum erythrocytic exposure in infancy and assess antibodies and malaria risk over two years .


Participants ( n = @ ) were enrolled at birth to one of three groups : late exposure , early exposure and control group , and were followed up for malaria morbidity and immunological analyses at birth , @ , @ , @ , @ and @ months of age .


Total IgG , IgG subclasses and IgM responses to MSP-@ ( @ ) , AMA-@ , and EBA-@ were measured by ELISA , and IgG against variant antigens on the surface of infected erythrocytes by flow cytometry .


Factors affecting antibody responses in relation to chemoprophylaxis and malaria incidence were evaluated .


Generally , antibody responses did not vary significantly between exposure groups except for levels of IgM to EBA-@ , and seropositivity of IgG@ and IgG@ to MSP-@ ( @ ) .


Previous and current malaria infections were strongly associated with increased IgG against MSP-@ ( @ ) , EBA-@ and AMA-@ ( p < @ ) .


After adjusting for exposure , only higher levels of anti-EBA-@ IgG were significantly associated with reduced clinical malaria incidence ( IRR @ , p = @ ) .


Overall , the age of first P. falciparum infection did not influence the magnitude and breadth of IgG responses , but previous exposure was critical for antibody acquisition .


IgG responses to EBA-@ were the strongest correlate of protection against clinical malaria .


Worldwide , @ million adults undergo major noncardiac surgery annually , and @ million of these patients will have a major vascular complication .


Low-dose clonidine and low-dose acetyl-salicylic acid ( ASA ) may prevent major perioperative vascular complications .


We therefore initiated the POISE-@ trial to establish the perioperative effects of these @ interventions .


The POISE-@ trial is a @ @ factorial randomized controlled trial of low-dose ASA vs. placebo and low-dose clonidine vs. placebo in @,@ patients at risk for a perioperative cardiovascular event who are undergoing noncardiac surgery .


Both study drugs are initiated prior to surgery ( goal @-@ hours ) and are continued after surgery .


Patients , health care providers , data collectors , and outcome adjudicators are blinded to treatment allocation .


The primary outcome is a composite of mortality and nonfatal myocardial infarction at @ days after randomization .


To date , the POISE-@ trial has recruited more than @,@ patients from @ centers in @ countries .


Among the first @,@ patients recruited , patients ' mean age was @ years , @ % were male , @ % had a history of vascular disease , and @ % had diabetes that was treated .


Participants had orthopedic ( @ % ) , general ( @ % ) , urologic or gynecologic ( @ % ) , vascular ( @ % ) , thoracic ( @ % ) , and other ( @ % ) surgery .


POISE-@ is a large international trial that will rigorously evaluate the effects of low-dose clonidine and ASA in patients having noncardiac surgery .


Onychomycosis is a therapeutic challenge because of the toxicities of systemic medications .


This has led to the investigation of light-based technologies for safe and effective alternative treatment modalities .


The purpose of this study was to determine the safety and efficacy of @ treatments with a @,@-nm neodymium : yttrium aluminum garnet ( Nd : YAG ) laser in improving the appearance of onychomycosis .


This study was a @-week , single-center randomized placebo-controlled study .


Ten subjects were enrolled with culture-proven , bilateral great toenail onychomycosis .


The subjects received @ treatments with the @,@-nm Nd : YAG laser to the treatment toenail on Days @ , @ , @ , and @ .


The control toenail received a sham treatment of cryogen cooling only .


Mycologic cultures were obtained at @-month follow-up visits .


Fifty percent of mycologic cultures were negative at the @-month follow-up after @ laser treatments .


Toenails had improvement in subungual debris , hypertrophy , and yellowing .


Patient satisfaction was upheld as assessed by the Nail Quality of Life Questionnaire .


The @,@-nm Nd : YAG laser may be a safe and effective therapy for improving the appearance of onychomycosis .


Additional therapy may be necessary to enhance long-term results .


Further investigation needs to explore the optimal treatment settings and the most effective treatment schedule .


Spaceflight studies and ground-based analogues of microgravity indicate a weakening of human immunity .


Mannan-binding lectin ( MBL ) and H - , L - , and M-ficolin together constitute the lectin pathway and mediate the clearance of pathogens through complement activation .


We hypothesized that simulated microgravity may weaken human innate immune functions and studied the impact of @ head-down tilted bed rest ( HDT ) for @ d on MBL and ficolin levels .


Within a @-mo period , seven men underwent two periods of HDT .


Blood samples were analyzed for MBL , H - , L - , and M-ficolin , mannose-binding lectin-associated protein of @ kDa ( MAp@ ) , and collectin liver @ ( CL-L@ ) by time-resolved immunofluorometric assays ( TRIFMA ) .


We observed well-defined individual preintervention levels of MBL and ficolins .


Remarkably similar intraindividual changes occurred for MBL and MBL levels decreased ( mean @ ng ml ) in the recovery phase .


Conversely , CL-L@ , a protein with MBL-like properties , increased ( mean @ ng ml ) during the recovery phase .


M-ficolin increased ( mean @ ng ml ) within the first @ d of HDT , followed by a decrease ( mean @ ng ml ) during the recovery phase .


L-ficolin increased ( mean @ ng ml ) during HDT , while H-ficolin was essentially unaffected .


MAp@ , a down-regulator of the lectin pathway , decreased initially ( mean @ ng ml ) in the recovery phase followed by an increase ( mean @ ng ml ) .


Alterations in MBL and ficolin levels were modest and with our current knowledge do not lead to overt immunodeficiency .


Pronounced changes occurred when the subjects resumed the upright position .


In selected individuals , these changes appear to be a conserved response to HDT .


Optimisation of patient comfort during flexible bronchoscopy is achieved with the use of intravenous sedation and vocal anaesthesia .


The effect of transcricoid lignocaine injection was investigated with regards to ease of procedure and frequency of cough .


A single-blinded study was carried out and two visual analogue scales were used as markers of efficacy .


Treatment groups were matched for age , gender and total dose of lignocaine administered .


The results highlighted a significant improvement in the perceived ease of procedure ( p < @ ) and frequency of coughing during the procedure ( p < @ ) .


The findings of the study demonstrate that the use of transcricoid injection of lignocaine provided a safe adjunct for anaesthesia in flexible bronchoscopy .


To evaluate a novel sleep education program for low-income preschool children and their families .


Randomized trial of an educational intervention .


Community-based .


Head Start preschool families ( n = @ ) in greater Lansing and Detroit , Michigan .


Classrooms or Head Start sites were randomized to an intervention group ( prompt intervention ) versus a control group ( delayed intervention ) .


Parents attended a one-time , @-min sleep education program and preschoolers received @ w ( @ total min ) of classroom sleep curriculum .


Parent knowledge , attitudes , self-efficacy , and beliefs were assessed as the primary outcomes just before the @-min sleep intervention , immediately postintervention , and approximately @ mo postintervention .


Parents reported their child 's bedtimes and wake times on @-day sleep diaries at baseline and at @-mo follow-up .


Average weeknight sleep durations and bedtimes served as secondary outcomes .


Linear mixed models showed a time treatment effect for parents ' knowledge , attitudes , and self-efficacy ( each P < @ ) but not beliefs .


These improvements were found immediately postintervention but were not retained at @-mo follow-up .


Children in the intervention group improved their weeknight sleep duration at @-mo follow-up by @ min ( @ @ h vs. @ @ hours at baseline ) compared to controls ( @ @ h versus @ @ h at baseline ) ( P = @ for difference between groups ) .


Children did not show statistically significant improvements in bedtime .


Educational interventions in early childhood can have an effect on parents ' sleep knowledge , attitudes , and self-efficacy , and on children 's sleep behavior .


However , repeated exposure to the new information may be important for parents as well as their children .


The objective of the study was to estimate the effect of Burch and fascial sling surgery on out-of-pocket urinary incontinence ( UI ) management costs at @ months postoperatively and identify predictors of change in cost among women enrolled in a randomized trial comparing these procedures .


Resources used for UI management ( supplies , laundry , dry cleaning ) were self-reported by @ women at baseline and @ months after surgery , and total out-of-pocket costs for UI management ( in @ US dollars ) were estimated .


Data from the @ surgical groups were combined to examine the change in cost for UI management over @ months .


Univariate and bivariate changes in cost were analyzed using the Wilcoxon signed rank test .


Predictors of change in cost were examined using multivariate mixed models .


At baseline mean ( SD ) age of participants was @ @ years , and the frequency of weekly UI episodes was @ @ .


Weekly UI episodes decreased by @ % at @ months ( P < @ ) .


The mean weekly cost was $ @ $ @ ( median $ @ ) at baseline and $ @ $ @ ( median $ @ ) at @ months ( P < @ ) , a decrease of @ % .


In multivariate analyses , cost decreased by $ @ $ @ per week for each decrease of @ UI episode per day ( P < @ ) and was strongly associated with greater improvement in Urogenital Distress Inventory and Incontinence Impact Questionnaire scores ( P < @ ) and decreased @-hour pad weight ( P < @ ) .


Following Burch or fascial sling surgery , the UI management cost at @ months decreased by @ % ( $ @ per woman per year ) and was strongly associated with decreasing UI frequency .


Reduced out-of-pocket expenses may be a benefit of these established urinary incontinence procedures .


To describe and evaluate the effectiveness of tailored intervention on village doctor 's use of electronic health records ( EHR ) in rural community health services in less developed areas .


Ten townships were selected .


In each township , two similar health service station ( CHSS ) were chosen .


One was randomly as allocated to the intervention group , the other to the control group .


Over six monthly visits , a structured on-site intervention including education , supervision and technical support was provided to village doctors in the intervention group tailored to their needs .


The Control group received no visits .


A sample of @ families from each CHSS was randomly chosen .


An online evaluation of each family 's EHR was conducted by the investigators at baseline and at the end of the @month intervention .


In the intervention group , the proportion of households with complete records increased : basic personal information from @ % to @ % , ( Z = -@ , P = @ ) and health education records from @ % to @ % ( Z = -@ , P = @ ) .


Similarly at baseline none of the @ elders had her records .


This increased in the intervention group to @ % recorded in part and @ % in full ( Z = -@ , P = @ ) .


The proportion of complete health management records for children aged @ to @years and @ to @years increased from @ % and @ % to @ % and @ % respectively ( the difference of children group @ to @years of age was statistically significant , Z = -@ , p = @ ) .


The proportion of complete basic clinic records in the intervention group increased from @ % to @ % ( Z = -@ , P = @ ) .


There were no significant differences in the control group .


The pilot study showed that a on-site education , supervision and technical support tailored to their needs was associated with improvements in village doctors use of EHR .


This model is worthy of implementation in other rural areas .


Blood management is critical in total knee arthroplasty ( TKA ) .


In bilateral , single stage TKA , blood loss seems more prominent .


We believe it is important to control all potential bleeding within the wound tissue .


The purpose of the study was to evaluate a series of topical procedures used to reduce blood loss and transfusion in single-stage bilateral cemented total knee arthroplasty : antifibrinolysis with tranexamic acid , vasoconstriction with epinephrine , sealing of the bone section intraoperatively , and closure of the drainage tube within the first @ h postoperatively .


Patients with osteoarthritis of the knees were randomly divided into two groups .


In group A , @ ml ( @ mg/ml ) tranexamic acid ( TXA ) and @ ml analgesic containing epinephrine ( @ g/ml ) solution were injected at several points into the posterior capsule before installation of the prosthesis .


The femoral medullar canal was closed with autograft bone and then sealed compressively with cement .


Before the tourniquet was released , @ ml TXA solution and @ ml analgesic containing epinephrine were injected at several points into the periosteum , synovium , joint capsule , tendons , and deep fascia tissue ( injection of analgesic containing epinephrine into subcutaneous fat and dermis was avoided ) .


The residual nail holes in the bone and the uncovered bone section were covered with bone wax .


The tourniquet was then removed , and active bleeding points were stanched .


TXA solution ( @ ml ) was injected into the articular cavity after wound closure .


The drainage tube was clamped for @ h , then opened .


In group B , injection of analgesic containing epinephrine into soft tissue , control of active bleeding , and clamping of the drainage tube for @-h , only , were performed .


Ninety patients were enrolled in the study .


Compared with those in group B , intraoperative blood loss , drainage volume , total postoperative blood loss , and number of patients requiring allogenic blood transfusion were significantly reduced in group A.


There was no significant difference between the incidence of complications in the groups .


Our topical procedures enable effective and safe reduction of blood loss and the number of patients requiring transfusion in single-stage bilateral osteoarthritic TKA .


Evaluate the discal morpho-structural changes as a predictive sign in the clinical outcome after ozone therapy in lumbar disc herniation using the T@-shine through effect in diffusion-weighted imaging ( DWI ) .


One hundred and fifty-four patients suffering from lumbosciatica ( @ men and @ women ; age range , @-@ years ) were included , previous MR study performed with FSE-T@ and T@-fat , SE-T@ and DWI sequences , and were randomly assigned to two groups .


Seventy-seven patients ( control group ) underwent conservative treatment with intraforaminal injection of steroid and anaesthetic .


The remaining @ patients ( study group ) underwent the same treatment with the addition of oxygen-ozone ( O@-O@ ) .


During the following six months , a MRI follow-up with the same sequences was performed .


An intervertebral disc volumetric analysis ( IDVA ) , DWI signal score and post treatment clinical outcome evaluation were performed for an assessment of hernia reduction .


test , Student 's t test and analysis of covariance were used for comparison of variables .


In the study group , @ of @ patients had a successful outcome ( responders ) .


In the responders group , DWI T@-shine through effect was present during MRI follow-up and in particular in @ of @ patients in six months of follow-up ( p < @ ) .


Moreover , in the same group a statistically significant disc shrinkage was shown by IDVA in sixth months of follow-up ( p < @ ) .


T@-shine through effect in DWI is present before morphological disc reduction and moreover could be considered as a predictive sign of response to oxygen-ozone treatment .


This update outlines changes to the MObile Technology for Improved Family Planning study statistical analysis plan and plans for long-term follow-up .


These changes result from obtaining additional funding and the decision to restrict the primary analysis to participants with available follow-up data .


The changes were agreed prior to finalising the statistical analysis plan and sealing the dataset .


The primary analysis will now be restricted to subjects with data on the primary outcome at @-month follow-up .


The extreme-case scenario , where all those lost to follow-up are counted as non-adherent , will be used in a sensitivity analysis .


In addition to the secondary outcomes outlined in the protocol , we will assess the effect of the intervention on long-acting contraception ( implant , intra-uterine device and permanent methods ) .


To assess the long-term effect of the intervention , we plan to conduct additional @-month follow-up by telephone self-report for all the primary and secondary outcomes used at @ months .


All participants provided informed consent for this additional follow-up when recruited to the trial .


Outcome measures and analysis at @ months will be similar to those at the @-month follow-up .


The primary outcomes of the trial will be the use of an effective modern contraceptive method at @ months and at @ months post-abortion .


Secondary outcomes will include long-acting contraception use , self-reported pregnancy , repeat abortion and contraception use over the @-month post-abortion period .


Restricting the primary analysis to those with follow-up data is the standard approach for trial analysis and will facilitate comparison with other trials of interventions designed to increase contraception uptake or use .


Undertaking @-month trial follow-up will allow us to evaluate the long-term effect of the intervention .


Diuretic unresponsiveness often occurs during hospital admission for acute heart failure ( AHF ) and is associated with adverse outcome .


This study aims to investigate determinants , clinical outcome , and the effects of nesiritide on diuretic response early after admission for AHF .


Diuretic response , defined as weight loss per @ mg of furosemide or equivalent , was examined from hospital admission to @ hours in @,@ patients from the ASCEND-HF trial .


As an additional analysis , a urinary diuretic response metric was investigated in @,@ patients using urine volume from hospital admission to @ hours per @ mg of furosemide or equivalent .


Mean diuretic response was -@ kg/@ mg of furosemide ( interquartile range -@ , -@ ) .


Poor responders had lower blood pressure , more frequent diabetes , long-term use of loop diuretics , poorer baseline renal function , and lower urine output ( all P < @ ) .


Randomized nesiritide treatment was not associated with diuretic response ( P = @ ) .


Good diuretic response was independently associated with a significantly decreased risk of @-day all-cause mortality or heart failure rehospitalization ( odds ratio @ , @ % CI @-@ @ , highest vs lowest quintile , P < @ ) .


Diuretic response based on urine output per @ mg of furosemide showed similar results in terms of clinical predictors , association with outcome , and the absence of an effect of nesiritide .


Poor diuretic response early after hospital admission for AHF is associated with low blood pressure , renal impairment , low urine output , and an increased risk of death or rehospitalization early after discharge .


Nesiritide had a neutral effect on diuretic response .


- Blockers have a class @a recommendation in the treatment of patients with ST-elevation myocardial infarctions ( STEMIs ) , as they are associated with a reduced mortality , recurrent myocardial infarction , life-threatening arrhythmias , and with prevention of unfavorable left ventricular remodeling .


Whether early administration before primary percutaneous coronary intervention ( PCI ) of intravenous - blockers reduces the infarct size in the current era is unknown .


We postulate that the early administration of - blockers will reduce the myocardial infarcted area as assessed by magnetic resonance imaging ( MRI ) at @ days .


In a multinational , multicenter , double-blind , placebo-controlled , randomized trial , patients with symptoms and signs of STEMI and transferred to a hospital for primary PCI will be randomized in a @:@ fashion to intravenous metoprolol ( @ mg twice daily ) administration or placebo .


Before admission , study treatment will be started as soon as possible after the diagnosis of STEMI .


After admission , primary PCI will be performed as per standard of care .


After primary PCI , medical treatment will occur as per current guidelines in all patients , including the use of oral - blockers .


The primary end point is the myocardial infarct size as assessed by MRI at @ days .


Based on a superiority design and assuming an @ % relative infarct size reduction ( from @ % to @ % ) , @ patients are required to be enrolled , accounting for @ % drop-out ( = @ and power = @ % ) .


The EARLY-BAMI trial is a multinational , multicenter , double-blind , placebo-controlled , randomized clinical trial that will investigate the impact of intravenous metoprolol administration before primary PCI for STEMI on myocardial infarct size as measured with MRI at @ days .


This randomized controlled multicenter trial evaluated coenzyme Q@ ( CoQ@ ) as adjunctive treatment in chronic heart failure ( HF ) .


CoQ@ is an essential cofactor for energy production and is also a powerful antioxidant .


A low level of myocardial CoQ@ is related to the severity of HF .


Previous randomized controlled trials of CoQ@ in HF were underpowered to address major clinical endpoints .


Patients with moderate to severe HF were randomly assigned in a @-year prospective trial to either CoQ@ @ mg @ times daily or placebo , in addition to standard therapy .


The primary short-term endpoints at @ weeks were changes in New York Heart Association ( NYHA ) functional classification , @-min walk test , and levels of N-terminal pro-B type natriuretic peptide .


The primary long-term endpoint at @ years was composite major adverse cardiovascular events as determined by a time to first event analysis .


A total of @ patients were enrolled .


There were no significant changes in short-term endpoints .


The primary long-term endpoint was reached by @ % of the patients in the CoQ@ group versus @ % in the placebo group ( hazard ratio : @ ; @ % confidence interval : @ to @ ; p = @ ) by intention-to-treat analysis .


The following secondary endpoints were significantly lower in the CoQ@ group compared with the placebo group : cardiovascular mortality ( @ % vs. @ % , p = @ ) , all-cause mortality ( @ % vs. @ % , p = @ ) , and incidence of hospital stays for HF ( p = @ ) .


In addition , a significant improvement of NYHA class was found in the CoQ@ group after @ years ( p = @ ) .


Long-term CoQ@ treatment of patients with chronic HF is safe , improves symptoms , and reduces major adverse cardiovascular events .


( Coenzyme Q@ as adjunctive treatment of chronic heart failure : a randomised , double-blind , multicentre trial with focus on SYMptoms , BIomarker status -LSB- Brain-Natriuretic Peptide ( BNP ) -RSB- , and long-term Outcome -LSB- hospitalisations/mortality -RSB- ; ISRCTN@ ) .


In ARDS , the extent of fibroproliferative activity on chest high-resolution CT ( HRCT ) scan has been reported to correlate with poorer short-term outcomes and pulmonary-associated quality of life .


However , clinical factors associated with HRCT scan fibroproliferation are incompletely characterized .


We questioned if lung compliance assessed at the bedside would be associated with fibroproliferation on HRCT scans obtained during the resolution phase of ARDS .


We used data from a published randomized , controlled clinical trial in ARDS .


All patients were cared for using a low tidal volume strategy .


Demographic data and ventilator parameters were examined in association with radiologic scores from chest HRCT scans obtained @ days after diagnosis .


Data from @ patients with ARDS were analyzed .


Average static respiratory compliance over the first @ days after diagnosis was inversely associated with chest HRCT scan reticulation ( = -@ ) ; this relationship persisted in multivariable analysis including APACHE ( Acute Physiology and Chronic Health Evaluation ) II scores , initial Pao@/Fio@ , pneumonia diagnosis , and ventilator days .


Average static respiratory compliance was also lower among patients with bronchiectasis at day @ ( P = @ ) .


Initial static respiratory compliance obtained within the first day after ARDS diagnosis was correlated inversely with the presence of HRCT scan reticulation ( = -@ ) and was lower among patients who demonstrated bronchiectasis on the day @ HRCT scan ( P = @ ) .


In patients with ARDS , diminished lung compliance measured bedside was associated with radiologic fibroproliferation @ days post diagnosis .


Establishing factors that predispose to development of excessive fibroproliferation with subsequent confirmation by chest HRCT scan represents a promising strategy to identify patients with ARDS at risk for poorer clinical outcomes .


To tackle the problems associated with high-dose dexamethasone ( HD-DXM ) in patients with immune thrombocytopenia ( ITP ) .


To compare the efficacy of HD-DXM with or without low-dose dexamethasone maintenance in untreated ITP patients .


Dexamethasone ( @ mg/day ) was given in @-day pulses every @ days for @ cycles in @ patients with ITP .


Among them , @ cases were given dexamethasone ( @ mg/kg per day ) for maintenance between pulsed HD-DXM and after @ HD-DXM courses ( HD-DXM-M group ) and another @ cases did not receive dexamethasone maintenance ( HD-DXM-nM group ) .


The control group comprised the patients who received prednisone ( prednisone group ) .


The following results were obtained : ( @ ) at the end of the @rd cycle , the overall response rate ( ORR ) was higher in the HD-DXM group than in the prednisone group ; ( @ ) the ORR of the HD-DXM group peaked after the @rd cycle ; ( @ ) the ORR after each course was higher in the HD-DXM-M group than in the HD-DXM-nM group ; ( @ ) in the @th month after HD-DXM discontinuation , the relapse rate of the HD-DXM-M group was lower than that of the other groups ( prednisone and HD-DXM-nM ) .


Treatment with @ cycles of HD-DXM pulses with low-dose dexamethasone maintenance is an effective method for untreated ITP .


Budesonide inhalation suspension ( BIS ) and montelukast provide acceptable asthma control , whereas overall measures favored BIS in children aged @ to @ years with mild persistent asthma .


We compared BIS and montelukast over a @-year period in children aged @ to @ years with asthma .


Data were derived from a @-week , open-label , randomized , active-controlled , multicenter study ( NCT@ ) .


Children with mild asthma received either BIS @ mg or montelukast @ to @ mg once daily .


Patients were stepped up to twice-daily BIS or oral corticosteroids for mild or severe asthma worsening , respectively .


Primary efficacy assessment was time to first additional asthma medication for exacerbation over @ weeks .


Two hundred two patients , age @ to @ years , received BIS ( n = @ ) or montelukast ( n = @ ) .


No difference was observed between the BIS and montelukast groups in median time to first additional asthma medication over @ weeks ( @ vs @ days ) .


Statistically significant differences were observed in favor of BIS over montelukast in the percentage of patients requiring oral steroids at @ weeks ( @ % vs @ % ; P = @ ) , the rate ( number/patient/year ) of additional courses of medication ( @ vs @ ; P = @ ) , the rate of additional oral steroid therapy ( @ vs @ ; P = @ ) , and caregivers ' ability to manage the patient 's symptoms ( P = @ ) .


Both treatments were well tolerated .


BIS and montelukast provided acceptable asthma control in children aged @ to @ years with mild persistent asthma with no significant difference between treatments in the primary end point ; however , several secondary outcomes showed statistically significant differences ( and many had numerical differences ) in favor of BIS over montelukast .


Anxiety and affective disorders can be disabling and have a major impact on the ability to work .


In Denmark , people with a mental disorder , and mainly non-psychotic disorders , represent a substantial and increasing part of those receiving disability pensions .


Previous studies have indicated that Individual Placement and Support ( IPS ) has a positive effect on employment when provided to people with severe mental illness .


This modified IPS intervention is aimed at supporting people with recently diagnosed anxiety or affective disorders in regaining their ability to work and facilitate their return to work or education .


To investigate whether an early modified IPS intervention has an effect on employment and education when provided to people with recently diagnosed anxiety or affective disorders in a Danish context .


The trial is a randomised , assessor-blinded , clinical superiority trial of an early modified IPS intervention in addition to treatment-as-usual compared to treatment-as-usual alone for @ participants diagnosed with an affective disorder or anxiety disorder living in the Capital Region of Denmark .


The primary outcome is competitive employment or education at @ months .


Secondary outcomes are days of competitive employment or education , illness symptoms and level of functioning including quality of life at follow-up @ and @ months after baseline .


If the modified IPS intervention is shown to be superior to treatment-as-usual , a larger number of disability pensions can probably be avoided and long-term sickness absences reduced , with major benefits to society and patients .


This trial will add to the evidence of how best to support people 's return to employment or education after a psychiatric disorder .


Chronic pain and disability of the arm , shoulder , and hand severely affect labor market participation .


Ergonomic training and education is the default strategy to reduce physical exposure and thereby prevent aggravation of pain .


An alternative strategy could be to increase physical capacity of the worker by physical conditioning .


To investigate the effect of @ contrasting interventions , conventional ergonomic training ( usual care ) versus resistance training , on pain and disability in individuals with upper limb chronic pain exposed to highly repetitive and forceful manual work .


Examiner-blinded , parallel-group randomized controlled trial with allocation concealment .


Slaughterhouses located in Denmark , Europe .


Sixty-six adults with chronic pain in the shoulder , elbow/forearm , or hand/wrist and work disability were randomly allocated to @ weeks of specific resistance training for the shoulder , arm , and hand muscles for @ x @ minutes per week , or ergonomic training and education ( usual care control group ) .


Pain intensity ( average of shoulder , arm , and hand , scale @ - @ ) was the primary outcome , and disability ( Work module of DASH questionnaire ) as well as isometric shoulder and wrist muscle strength were secondary outcomes .


Pain intensity , disability , and muscle strength improved more following resistance training than usual care ( P < @ , P = @ , P < @ , respectively -LSB- corrected -RSB- ) .


Pain intensity decreased by @ points ( @ % confidence interval -@ to -@ ) following resistance training compared with usual care , corresponding to an effect size of @ ( Cohen 's d ) .


Blinding of participants is not possible in behavioral interventions .


However , at baseline outcome expectations of the @ interventions were similar .


Resistance training at the workplace results in clinical relevant improvements in pain , disability , and muscle strength in adults with upper limb chronic pain exposed to highly repetitive and forceful manual work .


Diabetes is a serious metabolic disorder and oxidative stress and inflammation contribute to its pathogenesis and complications .


Since Silybum marianum ( L. ) Gaertn .


( silymarin ) extract is an antioxidant with anti-inflammatory properties , this randomized clinical trial was conducted to evaluate the effects of silymarin supplementation on oxidative stress indices and hs-CRP in type @ diabetes mellitus patients .


For the present paralleled , randomized , triple-blinded , placebo-controlled clinical trial , @ type @ diabetes patients aged @-@ yr old and on stable medication were recruited from the Iranian Diabetes Society and endocrinology clinics in East Azarbayjan ( Tabriz , Iran ) and randomly assigned into two groups .


Patients in the silymarin treatment group received @mg , thrice daily of dried extracts of Silybum marianum ( n = @ ) and those in the placebo group ( n = @ ) received identical placebos for @ days .


Data pertaining to height , weight , waist circumference and BMI , as well as food consumption , were collected at base line and at the conclusion of the study .


Fasting blood samples were obtained and antioxidant indices and hs-CRP were assessed at baseline , as well as at the end of the trial .


All @ patients completed the study and did not report any adverse effects or symptoms with the silymarin supplementation .


Silymarin supplementation significantly increased superoxide dismutase ( SOD ) , glutathione peroxidase ( GPX ) activity and total antioxidant capacity ( TAC ) compared to patients taking the placebo , by @ % , @ % and @ % , respectively ( p < @ ) .


There was a significant reduction in hs-CRP levels by @ % ( p < @ ) in the silymarin group compared to the placebo group .


Malondialdehyde ( MDA ) concentration significantly decreased by @ % ( p < @ ) in the silymarin group compared to the baseline .


Silymarin supplementation improves some antioxidant indices ( SOD , GPX and TAC ) and decrease hs-CRP levels in T@DM patients .


In previous phase @-@ clinical trials involving older adults , a subunit vaccine containing varicella-zoster virus glycoprotein E and the AS@B adjuvant system ( called HZ/su ) had a clinically acceptable safety profile and elicited a robust immune response .


We conducted a randomized , placebo-controlled , phase @ study in @ countries to evaluate the efficacy and safety of HZ/su in older adults ( @ years of age ) , stratified according to age group ( @ to @ , @ to @ , and @ years ) .


Participants received two intramuscular doses of the vaccine or placebo @ months apart .


The primary objective was to assess the efficacy of the vaccine , as compared with placebo , in reducing the risk of herpes zoster in older adults .


A total of @,@ participants who could be evaluated received either the vaccine ( @ participants ) or placebo ( @ participants ) .


During a mean follow-up of @ years , herpes zoster was confirmed in @ participants in the vaccine group and in @ participants in the placebo group ( incidence rate , @ vs. @ per @ person-years ) in the modified vaccinated cohort .


Overall vaccine efficacy against herpes zoster was @ % ( @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ ) .


Vaccine efficacy was between @ % and @ % for all age groups .


Solicited reports of injection-site and systemic reactions within @ days after vaccination were more frequent in the vaccine group .


There were solicited or unsolicited reports of grade @ symptoms in @ % of vaccine recipients and @ % of placebo recipients .


The proportions of participants who had serious adverse events or potential immune-mediated diseases or who died were similar in the two groups .


The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were @ years of age or older .


Vaccine efficacy in adults who were @ years of age or older was similar to that in the other two age groups .


( Funded by GlaxoSmithKline Biologicals ; ZOE-@ ClinicalTrials.gov number , NCT@ . )


Optimal emergent management of traumatic hemorrhagic shock patients requires a better understanding of treatment provided in the prehospital/Emergency Medical Services ( EMS ) and emergency department ( ED ) settings .


Hypothesis/Problem Described in this research are the initial clinical status , airway management , fluid and blood infusions , and time course of severely-injured hemorrhagic shock patients in the EMS and ED settings from the diaspirin cross-linked hemoglobin ( DCLHb ) clinical trial .


Data were analyzed from @ US trauma centers gathered during a randomized , controlled , single-blinded efficacy trial of a hemoglobin solution ( DCLHb ) as add-on therapy versus standard therapy .


Among the @ randomized patients , the mean EMS Glasgow Coma Scale ( GCS ) was @ ( SD = @ ) , the mean EMS revised trauma score ( RTS ) was @ ( SD = @ ) , and the mean injury severity score ( ISS ) was @ ( SD = @ ) .


Upon arrival to the ED , the GCS was @ % lower ( @ ( SD = @ ) vs @ ( SD = @ ) ) and the RTS was @ % lower ( @ ( SD = @ ) vs @ ( SD = @ ) ) than EMS values in blunt trauma patients ( P < @ ) .


By ED disposition , @ % of patients ( @/@ ) were intubated .


Rapid sequence intubation ( RSI ) was utilized in @ % ( @/@ ) , most often utilizing succinylcholine ( @ % ) and midazolam ( @ % ) .


The mean crystalloid volume infused was @ L ( SD = @ L ) , @ % of which was infused within the ED .


Emergency department blood transfusion occurred in @ % of patients , with an average transfused volume of @ L ( SD = @ L ) .


Blunt trauma patients received @ times more total fluids ( @ L vs @ L , < @ ) and @ times more blood ( @ L vs @ L , P < @ ) .


The mean time of patients taken from injury site to operating room ( OR ) was @ minutes ( SD = @ minutes ) .


Twenty-one ( @ % ) of the @ patients taken to the OR from the ED were sent within @ minutes of the estimated injury time .


Penetrating trauma patients were taken to the OR @ % sooner than blunt trauma patients ( @ minutes vs @ minutes , P < @ ) .


Both GCS and RTS decreased prior to ED arrival in blunt trauma patients .


Intubation was performed using RSI , and crystalloid infusion of three times the estimated blood loss volume ( L ) and blood transfusion of the estimated blood loss volume ( L ) were provided in the EMS and ED settings .


Surgical intervention for these trauma patients most often occurred more than one hour from the time of injury .


Penetrating trauma patients received surgical intervention more rapidly than those with a blunt trauma mechanism .


The purpose of this study was to use CT texture analysis to predict overall survival ( OS ) in patients with metastatic melanoma and stable disease ( SD ) according to the Response Evaluation Criteria in Solid Tumors ( RECIST ) on initial posttherapy CT images .


This retrospective study included @ patients with metastatic melanoma who received bevacizumab therapy in the context of a randomized prospective phase II clinical trial .


Target lesions on the baseline and initial posttherapy contrast-enhanced CT examinations were evaluated by CT texture analysis using TexRAD software before and after image filtering in patients with RECIST SD on initial posttherapy images .


Cox proportional hazards models were used to assess the associations of CT texture analysis measurements and of other patient factors with OS .


The AUC was used to evaluate predictive accuracy .


In multivariate analysis ( in @ patients with RECIST SD ; median OS , @ years ) , absolute change in mean positive pixels at spatial scaling filter of @ mm , change in tumor size , and baseline serum lactate dehydrogenase ( LDH ) level were predictors of OS ( hazard ratio -LSB- HR -RSB- = @ for decrease in mean positive pixels at spatial scaling filter of @ mm vs increase , p = @ ; HR = @ for > @ % increase in tumor size vs otherwise , p = @ ; and HR = @ for every @ IU/L increase in baseline LDH level , p = @ ) .


A prognostic index containing these three factors was highly accurate for predicting OS at @ months ( AUC = @ ) .


In patients with metastatic melanoma and RECIST SD on initial post-therapy CT images , a model incorporating CT texture analysis of target lesions , tumor size changes , and baseline LDH levels was highly accurate in predicting OS .


To determine the vitamin D dose necessary to achieve serum @-hydroxyvitamin D ( @ ( OH ) D ) concentration @ ng/mL during infancy .


A randomized , double-blind , placebo-controlled trial in New Zealand .


Pregnant mothers , from @ weeks ' gestation to birth , and then their infants , from birth to age @ months , were randomly assigned to @ of @ mother/infant groups : placebo/placebo , vitamin D@ @/@ IU , or vitamin D@ @/@ IU .


Serum @ ( OH ) D and calcium concentrations were measured at enrollment , @ weeks ' gestation , in cord blood , and in infants at @ , @ , and @ months of age .


Two-hundred-and-sixty pregnant women were randomized .


At enrollment , the proportions with serum @ ( OH ) D @ ng/mL for placebo , lower-dose , and higher-dose groups were @ % , @ % , and @ % , respectively .


The proportion with @ ( OH ) D @ ng/mL was larger in both intervention groups at @ weeks ' gestation ( @ % , @ % , @ % , P < @ ) .


In comparison with placebo , the proportion of infants with @ ( OH ) D @ ng/mL was larger in both intervention groups to age @ months : cord blood ( @ % , @ % , @ % , P < @ ) , @ months ( @ % , @ % , @ % , P < @ ) , and @ months ( @ % , @ % , @ % , P = @ ) , but only in the higher-dose group at age @ months ( @ % , @ % , @ % , P = @ ; higher dose versus placebo P = @ , lower dose versus placebo P = @ ) .


Daily vitamin D supplementation during pregnancy and then infancy with @/@ IU or @/@ IU increases the proportion of infants with @ ( OH ) D @ ng/mL , with the higher dose sustaining this increase for longer .


Botulinum toxin injection for lateral canthal rhytids has been reported to result in dry eye , but its effect on tear film stability and tear production has not been studied thoroughly .


To investigate the effect of botulinum toxin type A on tear film stability and tear production after treatment of lateral canthal rhytids .


We performed a clinical intervention study at a regional hospital in Taiwan of @ women @ to @ years of age with lateral canthal rhytids from January @ through December @ , @ .


Botulinum toxin type A at @ different preparations and doses ( dose A : @ injections of @ U in @ mL of normal saline per injection ; dose B : @ injections of @ U in @ mL of normal saline per injection ) was injected at the lateral canthal areas .


One eye of each study participant was randomly chosen for dose A , and the other eye received dose B.


Baseline tear film break-up time ( TBUT ) and Schirmer tests without and with anesthesia were measured before and at @ week , @ month , @ months , and @ months after botulinum toxin injection .


The TBUT and Schirmer test results were compared between different periods and doses .


The TBUT decreased significantly at @ week after botulinum toxin type A injection ( P = @ ) , and the effect persisted at @ month and @ months after treatment ( P = @ and @ , respectively ) .


In younger participants , the TBUT recovered faster than in older patients .


The results of the Schirmer tests without and with anesthesia decreased gradually , with significant reduction at @ month after treatment ( P = @ and @ , respectively ) and then recovered gradually .


Both the TBUT and Schirmer test results decreased more in eyes that received dose B than in those that received dose A ; however , none of the differences were statistically significant .


Tear film stability decreased as early as @ week after botulinum toxin type A treatment for lateral canthal rhytids , and the effect persisted for more than @ months .


Tear production decreased to the trough at @ month after treatment and then recovered gradually .


Contrast sensitivity sometimes increases in patients with open-angle glaucoma when intraocular pressure ( IOP ) is decreased .


Although often interpreted as demonstrating reversible glaucoma-induced dysfunction , this result , if true , could simply reflect a general relationship between sensitivity and IOP in visual mechanisms unaffected by glaucoma .


To investigate this relationship , we test the hypothesis that reducing IOP in eyes without glaucoma ( ocular hypertension ) does not increase perimetric contrast sensitivity .


Comparative case series .


A total of @ participants drawn from the Ocular Hypertension Treatment Study ( OHTS ) ( @ clinical centers ) .


Commercially available topical ocular hypotensive medications .


Post hoc analysis of IOP and perimetric contrast sensitivity ( mean deviation -LSB- MD -RSB- and pattern standard deviation -LSB- PSD -RSB- ) both at baseline ( @ months , immediately before ocular antihypertensive therapy ) and at @-month review .


An additional @ control eyes from OHTS that did not receive treatment were examined over the same period .


Data from the second phase of OHTS also were examined , and control eyes then received treatment .


Treated eyes had a decrease in IOP at @ months ( @ mmHg , P < @ ) but no significant change in MD ( @ decibels -LSB- dB -RSB- , P = @ ) or PSD ( @ dB , P = @ ) , relative to controls .


A similar decrease in IOP was found for eyes that began treatment in the second phase of OHTS , but no significant change in MD or PSD .


Despite using a large sample size , we found no relationship between perimetric contrast sensitivity and IOP reduction in ocular hypertension , which suggests that previous sensitivity changes seen in patients with glaucoma , if true , are indicative of reversible glaucoma-induced dysfunction rather than a general relationship between sensitivity and IOP in visual mechanisms unaffected by glaucoma .


Utilization rates ( URs ) for implantable cardioverter-defibrillators ( ICDs ) for primary prevention of sudden cardiac death ( PPSCD ) are lacking in the community .


The purpose of this study was to establish the ICD UR in central Indiana .


A query run on @ hospitals in a health information exchange database in Indianapolis identified patients between @ and @ with left ventricular ejection fraction ( EF ) @ .


ICD eligibility and utilization were determined from chart review .


We identified @ patients with at least @ low EF study .


Two cohorts were analyzed : @ patients without and @ patients with International Classification of Diseases , Ninth Revision , Clinical Modification procedure code @ for ICD placement .


We manually reviewed a stratified ( by hospital ) random sample of @ patients from the no-ICD procedure code cohort and found that @ ( @ % ) had no ICD but had class I indications for ICD .


Eight of @ ( @ % ) actually had ICD implantation for PPSCD .


Review of all @ patients in the ICD procedure code cohort identified @ with ICD implantation for PPSCD .


The ICD UR ( ratio between patients with ICD for PPSCD and all with indication ) was @ % overall ( @ % confidence interval -LSB- CI -RSB- @ % -@ % ) .


URs were @ % for males ( @ % CI @ % -@ % ) , @ % for females ( @ % CI @ % -@ % , P = @ vs males ) , @ % for whites ( @ % CI @ % -@ % ) , and @ % for blacks ( @ % CI @ % -@ % , P = @ vs whites ) .


ICD UR is @ % among patients meeting class I indications , suggesting further opportunities for improving guideline compliance .


This study also illustrates limitations in calculating ICD UR using large electronic repositories without hands-on chart review .


Diabetic foot wounds are a highly morbid and costly complication of diabetes mellitus .


Targeted amino acid supplementation , by increasing tissue hydroxyproline concentrations , has been implicated in improved wound outcomes in surgical incisions and chronic wounds , and after radiation injury .


A major component of collagen , hydroxyproline is a surrogate marker used commonly for tissue collagen concentrations .


This paper reviews the literature pertaining to amino acid supplementation and wound healing , and also evaluates our pilot data relating to supplementation with arginine , glutamine , and beta-hydroxy-beta-methylbutyrate ( HMB ) in the treatment of diabetic foot ulcers .


For the pilot study , nine patients scheduled to undergo wound debridement for diabetic foot ulcers were randomized prospectively to be a part of either a placebo group or a treatment group that received supplementation twice daily for @ wks .


Tissue samples were collected both before and after @ wk of supplementation .


The results of assay of the samples for hydroyproline were then analyzed via a one tailed Student t-test to evaluate tissue concentrations of hydroxyproline .


For the literature review in the study , the MEDLINE/PubMed database was reviewed , using search terms contained in the Medical Subject Headings ( MeSH ) .


The treatment group in the study exhibited a significantly greater hydroxyproline concentration after supplementation than before it ( p = @ ) .


The mean percent change in the tissue hydroxyproline concentration for arginine , glutamine , and HMB group was +@ % , with a standard deviation ( SD ) of @ .


The mean percent change for the corresponding amino acids in the placebo group was -@ % , with an SD of @ .


The review of the MEDLINE/PubMed literature revealed only two human studies of amino acid supplementation in patients with diabetic foot wounds , one of which found a significant improvement in wound-depth and wound-appearance scores .


Given the results of our pilot study , and on the basis of a review of the literature , the administration of a simple amino acid supplement may improve the healing of diabetic foot wounds via increased collagen production .


Using a through-the-needle local anesthetic bolus technique , ultrasound-guided infraclavicular perineural catheters have been shown to provide greater analgesia compared to supraclavicular catheters .


A through-the-catheter bolus technique , which arguably `` tests '' the anesthetic efficacy of the catheter before initiating an infusion , has been validated for infraclavicular catheters but not supraclavicular catheters .


This study investigated the through-the-catheter bolus technique for supraclavicular catheters and tested the hypothesis that infraclavicular catheters provide faster onset of brachial plexus anesthesia .


Preoperatively , patients were randomly assigned to receive either a supraclavicular or an infraclavicular catheter using an ultrasound-guided nonstimulating catheter insertion technique with a mepivacaine bolus via the catheter and ropivacaine perineural infusion initiated postoperatively .


The primary outcome was time to achieve complete sensory anesthesia in the ulnar and median nerve distributions .


Secondary outcomes included procedural time , procedure-related pain and complications , and postoperative pain , opioid consumption , sleep disturbances , and motor weakness .


Fifty patients were enrolled in the study ; all but @ perineural catheters were successfully placed per protocol .


Twenty-one of @ ( @ % ) and @ of @ ( @ % ) patients in the supraclavicular and infraclavicular groups , respectively , achieved complete sensory anesthesia by @ minutes ( P = @ ) .


There was no difference in the time to achieve complete sensory anesthesia .


Supraclavicular patients reported more sleep disturbances postoperatively , but there were no statistically significant differences in other outcomes .


Both supraclavicular and infraclavicular perineural catheters using a through-the-catheter bolus technique provide effective brachial plexus anesthesia .


Idarucizumab is a monoclonal antibody fragment that binds dabigatran with high affinity in a @:@ molar ratio .


We investigated the safety , tolerability , and efficacy of increasing doses of idarucizumab for the reversal of anticoagulant effects of dabigatran in a two-part phase @ study ( rising-dose assessment and dose-finding , proof-of-concept investigation ) .


Here we present the results of the proof-of-concept part of the study .


In this randomised , placebo-controlled , double-blind , proof-of-concept phase @ study , we enrolled healthy volunteers ( aged @-@ years ) with a body-mass index of @-@ kg/m ( @ ) into one of four dose groups at SGS Life Sciences Clinical Research Services , Belgium .


Participants were randomly assigned within groups in a @:@ ratio to idarucizumab or placebo using a pseudorandom number generator and a supplied seed number .


Participants and care providers were masked to treatment assignment .


All participants received oral dabigatran etexilate @ mg twice daily for @ days and a final dose on day @ .


Idarucizumab ( @ g , @ g , or @ g @-min infusion , or @ g plus @ g in two @-min infusions given @ h apart ) was administered about @ h after the final dabigatran etexilate dose .


The primary endpoint was incidence of drug-related adverse events , analysed in all randomly assigned participants who received at least one dose of dabigatran etexilate .


Reversal of diluted thrombin time ( dTT ) , ecarin clotting time ( ECT ) , activated partial thromboplastin time ( aPTT ) , and thrombin time ( TT ) were secondary endpoints assessed by measuring the area under the effect curve from @ h to @ h ( AUEC@-@ ) after dabigatran etexilate ingestion on days @ and @ .


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


Between Feb @ , and Nov @ , @ , @ men completed this part of the study .


@ were enrolled into each of the @ g , @ g , or @ g plus @ g idarucizumab groups ( nine to idarucizumab and three to placebo in each group ) , and @ were enrolled into the @ g idarucizumab group ( eight to idarucizumab and three to placebo ) .


Drug-related adverse events were all of mild intensity and reported in seven participants : one in the @ g idarucizumab group ( infusion site erythema and hot flushes ) , one in the @ g plus @ g idarucizumab group ( epistaxis ) ; one receiving placebo ( infusion site haematoma ) , and four during dabigatran etexilate pretreatment ( three haematuria and one epistaxis ) .


Idarucizumab immediately and completely reversed dabigatran-induced anticoagulation in a dose-dependent manner ; the mean ratio of day @ AUEC@-@ to day @ AUEC@-@ for dTT was @ with placebo , @ with @ g idarucizumab ( @ % reduction ) , @ with @ g idarucizumab ( @ % reduction ) , @ with @ g idarucizumab ( @ % reduction ) , and @ with @ g plus @ g idarucizumab ( @ % reduction ) .


No serious or severe adverse events were reported , no adverse event led to discontinuation of treatment , and no clinically relevant difference in incidence of adverse events was noted between treatment groups .


These phase @ results show that idarucizumab was associated with immediate , complete , and sustained reversal of dabigatran-induced anticoagulation in healthy men , and was well tolerated with no unexpected or clinically relevant safety concerns , supporting further testing .


Further clinical studies are in progress .


Recent studies indicate that persistent intestinal inflammation in patients with Crohn 's disease ( CD ) might be caused by abnormal intestinal microbiota .


This hypothesis may suggest a beneficial effect of antibiotics in CD therapy .


So far , guidelines do not recommend antibiotics except in the treatment of complicated CD , and there are few studies on the effects of rifaximin in these patients .


Between December @ and December @ , we performed a blinded randomized trial in @ patients with a previous history of moderately active CD concerning the efficacy of rifaximin .


All the patients had previously achieved remission with standard therapy ( prednisone/budesonide ) .


Data from patients receiving @ mg of rifaximin ( @ patients ) twice a day for @ weeks were compared with those from patients who received placebo ( @ patients ) .


The primary endpoint was maintaining remission during the follow-up .


All the patients ( @ % ; @/@ ) on @ mg of rifaximin were in remission after @ weeks of treatment in comparison with @ % ( @/@ ) of the placebo group .


This significant difference was also persistent at the @-week follow-up -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , respectively -RSB- .


The last evaluation performed at @ weeks revealed disease activity in @ % ( @/@ ) of the patients of the rifaximin group , i.e. a significant decrease compared with the placebo group -LSB- @ % ( @ of @ ) -RSB- .


Remission previously obtained with standard treatment can be sustained in patients with moderately active CD after the administration of @ mg of rifaximin .


It is well known that to acquire sensorimotor ( SMR ) - based brain-computer interface ( BCI ) control requires a training period before users can achieve their best possible performances .


Nevertheless , the effect of this training procedure on the cortical activity related to the mental imagery ability still requires investigation to be fully elucidated .


The aim of this study was to gain insights into the effects of SMR-based BCI training on the cortical spectral activity associated with the performance of different mental imagery tasks .


Linear cortical estimation and statistical brain mapping techniques were applied on high-density EEG data acquired from @ healthy participants performing three different mental imagery tasks .


Subjects were divided in two groups , one of BCI trained subjects , according to their previous exposure ( at least six months before this study ) to motor imagery-based BCI training , and one of subjects who were naive to any BCI paradigms .


Cortical activation maps obtained for trained and naive subjects indicated different spectral and spatial activity patterns in response to the mental imagery tasks .


Long-term effects of the previous SMR-based BCI training were observed on the motor cortical spectral activity specific to the BCI trained motor imagery task ( simple hand movements ) and partially generalized to more complex motor imagery task ( playing tennis ) .


Differently , mental imagery with spatial attention and memory content could elicit recognizable cortical spectral activity even in subjects completely naive to ( BCI ) training .


The present findings contribute to our understanding of BCI technology usage and might be of relevance in those clinical conditions when training to master a BCI application is challenging or even not possible .


To observe the intervention effect of Leihong Granule ( LG ) in in-stent restenosis ( ISR ) after endovascular therapy for lower extremity arterial occlusive diseases ( LEAOD ) .


Recruited @ LEAOD patients who successfully underwent endovascular therapy ( balloon dilation and stent implantation ) were randomly assigned to two groups , the control group and the LG group , @ in each group .


Patients in the control group received basic treatment , while those in the LG group additionally took LG for @ months .


Plasma levels of IL-@ , IL-@ , CRP , and the intima-media thickness ( IMT ) of lower extremity artery were observed in the two groups between and after treatment .


The rate of stent patency , ABI , intermittent claudication , rest pain , and the incidence of amputation the two groups were recorded and observed in the two groups .


In the control group , serum levels of IL-@ , IL-@ , CRP , and IMT were significantly higher one month after surgery than before surgery ( P < @ ) .


There was no significant difference in serum levels of IL-@ , IL-@ , CRP , or IMT between the two groups before surgery ( P > @ ) .


These indices were obviously lower in the LG group than in the control group after surgery ( P < @ ) .


Compared with the control group , the incidence rates of intermittent claudication and the rest pain at @ months and @ months after surgery significantly decreased ( P < @ ) .


The stent patency rate at @ months and @ months after surgery , and ABI were significantly higher than those of the control group ( P < @ ) .


There was no statistical difference in the amputation rate between the two groups ( P > @ ) .


LG might effectively improve ischemic symptoms of affected limbs possibly through lowering the ISR rate after endovascular therapy for LEAOD through preventing immunosuppressive actions .


The aim of the study ; LCoMotion - Learning , Cognition and Motion was to develop , document , and evaluate a multi-component physical activity ( PA ) intervention in public schools in Denmark .


The primary outcome was cognitive function .


Secondary outcomes were academic skills , body composition , aerobic fitness and PA. .


The primary aim of the present paper was to describe the rationale , design and methods of the LCoMotion study .


LCoMotion was designed as a cluster-randomized controlled study .


Fourteen schools from all five regions in Denmark participated .


All students from @th and @th grades were invited to participate ( n = @ ) and consent was obtained for @ % ( n = @ ) .


Baseline measurements were obtained in November/December @ and follow-up measurements in May/June @ .


The intervention lasted five months and consisted of a `` package '' of three main components : PA during academic lessons , PA during recess and PA homework .


Furthermore a cycling campaign was conducted during the intervention period .