Unique identifier : NCT01537393 .


The aim of the present study was to evaluate the periodontal regenerative capacity of demineralized freeze-dried bone allograft ( DFDBA ) alone or used with local lincomycin .


In the present single-blind , randomized , controlled clinical trial , 20 subjects 26 years old or older , requiring extraction of bilateral third molars ( M3s ) , were included .


Each subject was randomly assigned to receive either DFDBA or DFDBA plus lincomycin therapy .


Within the subjects , 1 M3 site was randomly selected to be the experimental site and the contralateral served as the control and was permitted to heal without intervention .


The primary variables were changes in the probing depth ( PD ) , clinical alveolar bone levels ( ABLs ) , and radiographic alveolar bone density ( ABD ) on the distal aspect of second molar between baseline ( immediately postoperatively ) and 26 weeks postoperatively ( T26 ) .


Appropriate sample sizes and descriptive , bivariate , and multivariate statistics were computed .


For both treatment and control sites , between T0 and T26 , statistically significant improvements were seen in the ABLs and ABD ( P < .05 ) .


Within-subject comparisons showed no significant differences in PD , ABL , or ABD between the treatment and control M3 sites at T0 or T26 ( P > .05 ) .


Also , no significant differences were found in the PD , ABL , or ABD between the 2 treatment M3 sites at T26 ( P > .05 ) .


The results of the present study have revealed that the PD , ABL , and ABD improved after M3 removal in subjects 26 years old or older , irrespective of the treatment or control group .


Reconstructive procedures ( e.g. , DFDBA with or without lincomycin therapy ) did not offer predictable benefits compared with a no-treatment protocol in patients younger than 30 years old .


To compare outcomes of phaco-canaloplasty ( PC ) and phaco-non-penetrating deep sclerectomy ( PDS ) with a viscoelastic compound .


This study included 29 eyes after PC and 30 after PDS .


Indications were uncontrolled primary open-angle glaucoma ( POAG ) and a cataract .


Corrected distance visual acuity ( CDVA ) , intraocular pressure ( IOP ) , and number of medications were evaluated .


Follow-up examinations were performed on days 1 and 7 , and after 1 , 3 , 6 , and 12 months .


Complete and qualified success was an IOP 18 mmHg .


At the 12-month follow-up , mean IOP decreased in the PC group from 19.06.9 mmHg to 12.62.7 mmHg , and in the PDS group , from 19.15.8 mmHg to 14.33.5 mmHg ( P < 0.05 ) .


Both groups preoperatively and at 12 months showed no significant differences in IOP ( P > 0.05 ) .


There was no statistically significant difference between the number of medications used ( P > 0.05 ) .


Complete and qualified success rates for both groups were 79.0 % and 76.9 % ( P = 0.701 ) .


The most frequent postoperative PC complication was hyphema ( 58.0 % ) ; for PDS , bleb fibrosis was most frequent ( 26.7 % ) .


No PC patients required postoperative management .


PDS patients required postoperative interventions 58.7 % of the time , including a 5-fluorouracil ( 5-FU ) injection ( 58.7 % ) , suture lysis ( 48.3 % ) , and needling ( 27.6 % ) .


Both PC and PDS lead to an effective decrease in IOP on a short-term follow-up basis and demonstrate similar efficacy and safety profiles .


PDS patients required additional procedures including 5-FU injections , suture lysis , or needling .


PC patients required no additional procedures .


Type 2 diabetes ( T2D ) brings significant human and healthcare costs .


Its progressive nature means achieving normoglycaemia is increasingly difficult , yet critical to avoiding long term vascular complications .


Nearly one-half of people with T2D have glycaemic levels out of target .


Insulin is effective in achieving glycaemic targets , yet initiation of insulin is often delayed , particularly in primary care .


Given limited access to specialist resources and the size of the diabetes epidemic , primary care is where insulin initiation must become part of routine practice .


This would also support integrated holistic care for people with diabetes .


Our Stepping Up Program is based on a general practitioner ( GP ) and practice nurse ( PN ) model of care supported appropriately by endocrinologists and credentialed diabetes educator-registered nurses .


Pilot work suggests the model facilitates integration of the technical work of insulin initiation within ongoing generalist care .


This protocol is for a cluster randomized controlled trial to examine the effectiveness of the Stepping Up Program to enhance the role of the GP-PN team in initiating insulin and improving glycaemic outcomes for people with T2D .


224 patients between the ages of 18 and 80 years with T2D , on two or more oral hypoglycaemic agents and with an HbA1c 7.5 % in the last six months will be recruited from 74 general practices .


The unit of randomization is the practice.Primary outcome is change in glycated haemoglobin HbA1c ( measured as a continuous variable ) .


We hypothesize that the intervention arm will achieve an absolute HbA1c mean difference of 0.5 % lower than control group at 12 months follow up .


Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA1c measurement of < 7.0 % .


We will also collect data on patient psychosocial outcomes and healthcare utilization and costs .


The study is a pragmatic translational study with important potential implications for people with T2D , healthcare professionals and funders of healthcare though making better use of scarce healthcare resources , improving timely access to therapy that can improve disease outcomes .


Australian and New Zealand Clinical Trials Registry ACTRN12612001028897 .


Probiotics have a possible role in the treatment of pediatric acute gastroenteritis .


We report the effect of the probiotic Lactobacillus rhamnosus GG ( LGG ) on intestinal function , immune response , and clinical outcomes in Indian children with cryptosporidial or rotavirus diarrhea .


Children with gastroenteritis aged 6 months to 5 years , testing positive for either rotavirus or Cryptosporidium species in stool ( coinfections were excluded ) , were randomized to LGG ( ATCC 53103 ) or placebo , once daily for 4 weeks .


Baseline demographic and clinical details were obtained .


Sera were tested for immunoglobulin G ( IgG ) and immunoglobulin A ( IgA ) antibodies to Cryptosporidium and rotavirus , and the lactulose to mannitol ratio for intestinal permeability was determined at baseline and at the end of follow-up .


Of the 124 children enrolled , 82 and 42 had rotavirus and cryptosporidial diarrhea , respectively .


Median diarrheal duration was 4 days ; one-third of the children had severe diarrhea .


Baseline and clinical parameters were comparable between children receiving LGG and placebo .


At the end of follow-up , fewer children with rotavirus diarrhea on LGG had repeated diarrheal episodes ( 25 % vs 46 % ; P = .048 ) and impaired intestinal function ( 48 % vs 72 % ; P = .027 ) .


Significant increase in IgG levels postintervention ( 456 vs 2215 EU ; P = .003 ) was observed in children with rotavirus diarrhea receiving LGG .


Among children with cryptosporidial diarrhea , those receiving LGG showed significant improvement in intestinal permeability .


LGG has a positive immunomodulatory effect and may be useful in decreasing repeated episodes of rotavirus diarrhea .


Improvement in intestinal function in children with rotavirus and cryptosporidial gastroenteritis emphasizes the role of probiotics in treating intestinal impairment after infection .


CTRI/2010/091 / 000339 .


Arthroscopic shoulder surgery can result in substantial postoperative pain .


This study evaluated the efficacy and safety of tapentadol immediate release ( IR ) or oxycodone IR in this setting for the treatment of acute pain .


Subjects received tapentadol IR 50 or 100 mg or oxycodone IR 5 or 10 mg every 4-6 hours as needed for pain up to 7 days after arthroscopic shoulder surgery .


Twice daily , subjects recorded pain intensity from 0 ( no pain ) to 10 ( pain as bad as you can imagine ) and pain relief from 0 ( none ) to 5 ( complete ) .


Final assessments included patient and clinician global impression of change and subject satisfaction with treatment .


The primary efficacy endpoint was the sum of pain intensity differences ( SPID ) over 3 days .


Of 378 subjects ( 192 tapentadol IR , 186 oxycodone IR ) who took study medication , 312 ( 158 tapentadol IR , 154 oxycodone IR ) had pain intensity 4 before the first dose and were evaluated for efficacy .


Mean SPID scores over 3 days were 32.1 and 41.1 in the tapentadol IR and oxycodone IR groups , respectively ( least-squares mean difference [ 95 % confidence interval ] , 9.0 [ -18.9 , 36.9 ] ; p = 0.527 ) .


Secondary analyses of pain intensity , pain relief , and subject satisfaction were similar between groups .


Subjects and clinicians reported significantly better global impression of change for tapentadol IR .


Adverse events were consistent with established safety profiles for IR opioids .


Tapentadol IR and oxycodone IR had similar efficacy for pain after arthroscopic shoulder surgery , but subjects and clinicians reported greater overall improvement with tapentadol IR .


Dietary modification may be important in the prevention and control of chronic adult periodontitis .


The role of promoting an adequate consumption of fruits , vegetables and whole grains in chronic periodontitis has not been thoroughly investigated .


The main aim of this dietary intervention study was to assess the influence of a customised dietary intervention ( aiming to increase the consumption of fruits , vegetables and whole grains ) on antioxidant status in adults with chronic periodontitis .


Fifty-one participants , aged 30-65 years , were recruited from a U.K. Dental Hospital and randomly allocated to an intervention or control group .


Both groups received normal clinical treatment but customised dietary advice was delivered to the intervention group by a community nutrition assistant .


Dietary intakes , anthropometric parameters and biochemical indices with respect to blood and saliva and periodontal indices were evaluated at baseline , as well as at 3 and 6 months post-dietary intervention .


At 3 and 6 months post-intervention , the intervention group showed a significant ( P < 0.05 ) increase in plasma total antioxidant capacity measured by Trolox equivalent antioxidant capacity assay compared to the control group .


At 3 and 6 months after dietary intervention , the intervention group had significantly higher intakes of fruits and vegetables compared to the control group .


The intake of whole grain was significantly higher in the intervention group than in the control group , 6 months post-intervention .


No significant differences were observed with respect to periodontal indices between groups .


It is suggested that dietary advice may help to improve dietary habits and , consequently , the antioxidant status of patients with chronic periodontitis .


However , the impact of such intervention on periodontal indices needs further investigation .


The purpose of this study was to explore in greater depth the outcomes of the Italian randomized trial investigating the role of pelvic lymphadenectomy in clinical early stage endometrial cancer .


In the attempt to identify the patients with poorer prognosis , the impact of age and body mass index were also thoroughly investigated by cancer-specific survival ( CSS ) analyses .


Survival outcomes of trial patients were analyzed in relation to age ( 65 years and > 65 years ) in the 2 arms ( lymphadenectomy and no lymphadenectomy ) and in the whole population of the trial .


Univariate and multivariable analyses of CSS and overall survival ( OS ) of patients showed that age > 65 years is a strong independent poor prognostic factor ( 5-y OS 92.1 % and 78.4 % in 65 years and > 65 years patients , respectively , P < .0001 ; 5-y CSS 93.8 % and 83.5 % in 65 years and > 65 years patients , respectively , P = .003 ) .


Among women 65 years , node negative patients had 94.4 % 5-y OS and 96.3 % 5-y CSS vs 74.3 % 5-y OS and 74.3 % 5-y CSS for node positive patients ( P = .009 and P = .002 , respectively ) , while among women > 65 y , node negative patients had 75.7 % 5-y OS and 83.6 % 5-y CSS vs 74.1 % 5-y OS and 83.3 % 5-y CSS for node positive patients ( P = .55 and P = .58 , respectively ) .


Univariate and multivariable survival analyses in the whole trial population showed that older age , and higher tumor grade and stage were significantly associated to a worse prognosis .


Older women faced an intrinsic poorer survival whether or not they underwent lymphadenectomy , and , unexpectedly , irrespective of the presence of nodal metastasis .


Only in older patients was obesity ( body mass index > 30 ) significantly associated with scarce prognosis .


Treatment decisions for older patients with type 2 diabetes mellitus must balance glycemic control and adverse event risk .


The objective of this study was to evaluate the long-term safety and tolerability of saxagliptin 5 mg as add-on therapy to common antihyperglycemic drugs in patients aged 65 years and < 65 years .


Pooled adverse event data from three placebo-controlled trials of 76-206 weeks ' duration in older ( 65 years ) and younger ( < 65 years ) patients receiving saxagliptin 5 mg or matching placebo added to metformin , glyburide , or a thiazolidinedione were analyzed .


Measurements were calculated from day of first dose to specified event or last dose and included time at risk for adverse events , treatment-related adverse events , serious adverse events , adverse events leading to discontinuation , and events of special interest .


Weighted incidence rates ( number of events/total time ) and incidence rate ratios ( saxagliptin/placebo ) with 95 % confidence intervals were calculated ( Mantel-Haenszel test ) .


A total of 205 older ( mean age 69 years ; saxagliptin , n = 99 ; placebo , n = 106 ) and 1,055 younger ( mean age 52 years ; saxagliptin , n = 531 ; placebo , n = 524 ) patients were assessed .


Regardless of age category , the adverse event incidence rates were generally similar between treatments , with confidence intervals for incidence rate ratios bridging 1 .


Treatment-related adverse events occurred in 36 older patients receiving saxagliptin versus 32 receiving placebo ( incidence rate 34.1 versus 27.1 per 100 person-years ) and in 150 younger patients in both treatment groups ( incidence rate 24.0 versus 27.8 per 100 person-years ) .


With saxagliptin versus placebo , serious adverse events occurred in eight versus 14 older ( incidence rate 5.7 versus 9.9 per 100 person-years ) and 49 versus 44 younger patients ( incidence rate 6.5 versus 6.6 per 100 person-years ) .


There were two deaths ( one patient 65 years ) with saxagliptin and six ( none aged 65 years ) with placebo .


Older patients rarely experienced symptomatic confirmed hypoglycemia ( fingerstick glucose 50 mg/dL ; saxagliptin , n = 1 ; placebo , n = 2 ) .


Saxagliptin add-on therapy was generally well tolerated in older patients aged 65 years with type 2 diabetes mellitus , with a long-term safety profile similar to that of placebo .


Genetic knockout or pharmacological inhibition of the beta-2 adrenergic receptor ( B2AR ) increased bone mass , whereas stimulation decreased bone mass in rodents .


In humans , observational studies support sympathetic nervous system regulation of bone metabolism , but intervention studies are lacking .


We aimed to determine the effects of a selective beta-2 adrenergic agonist and non-selective antagonist on human bone metabolism .


32 healthy postmenopausal women were included in a randomized controlled trial conducted in the Academic Medical Center Amsterdam .


Participants were randomized to receive treatment with 17 - estradiol 2mg/day ; 17 - estradiol 2mg/day and terbutaline 5mg/day ( selective B2AR agonist ) ; propranolol 80mg/day ( non-selective B-AR antagonist ) ; or no treatment during 12weeks .


Main outcome measure was the change in serum concentrations of procollagen type I N propeptide ( P1NP ) and C-terminal crosslinking telopeptides of collagen type I ( CTx ) as markers of bone formation and resorption after 12weeks compared between the treatment groups .


Data were analyzed with mixed model analysis .


17 - estradiol decreased bone turnover compared to control ( P1NP p < 0.001 , CTx p = 0.003 ) , but terbutaline combined with 17 - estradiol failed to increase bone turnover compared to 17 - estradiol alone ( P1NP p = 0.135 , CTx p = 0.406 ) .


Propranolol did not affect bone turnover compared to control ( P1NP p = 0.709 , CTx p = 0.981 ) .


Selective beta-2 adrenergic agonists and non-selective beta-antagonists do not affect human bone turnover although we can not exclude small changes below the detection limit of this study .


The Personal Calorie Monitor ( PCM ) is a portable direct calorimeter that estimates energy expenditure ( EE ) from measured heat flux ( i.e. , the sum of conductive , convective , radiative , and evaporative heat ) .


The primary aim of this study was to compare EE estimated from measures of heat flux with those measured using indirect calorimetry in a thermoneutral environment ( 26C ) .


A secondary aim was to determine whether exposure to ambient temperature below thermoneutral condition ( 19C ) influences the accuracy of the PCM .


Thirty-four adults ( mean SD : age , 28 5 yr ; body mass index , 22.9 2.6 kg m ( -2 ) ) were studied for 5 h in a whole-room indirect calorimeter ( IC ) in thermoneutral and cool conditions .


Participants wore the PCM on their upper arm and completed two 20-min treadmill walking bouts ( 0 % grade , 3 mph ) .


The remaining time was spent sedentary ( e.g. , watching television , using a computer ) .


In thermoneutral conditions , EE values ( mean ( 95 % confidence interval ) ) measured by IC and PCM were 560.0 ( 526.5-593 .5 ) and 623.3 ( 535.5-711 .1 ) kcal , respectively .


In cool conditions , EE values measured by IC and PCM were 572.5 ( 540.9-604 .0 ) and 745.5 ( 668.1-822 .8 ) kcal , respectively .


Under thermoneutral conditions , mean PCM minute-by-minute EE tracked closely with IC , resulting in a small nonsignificant bias ( 63 kcal ( -5.8 to 132.4 ) ) .


During cool conditions , mean PCM minute-by-minute EE did not track IC , resulting in a large bias ( 173.0 kcal ( 93.9-252 .1 ) ) ( P < ; 0.001 ) .


This study demonstrated the validity of using measured heat flux to estimate EE .


However , accuracy may be impaired in cool conditions possibly because of excess heat loss from the exposed limbs .


To determine the accuracy and precision of simultaneous noninvasive blood pressure ( NIBP ) measurement in the arm , forearm , and ankle in anesthetized children .


Prospective , randomized study .


University medical center .


101 ASA physical status 1 and 2 children ( aged 1-8 yrs ) scheduled for elective surgery with general anesthesia .


Simultaneous NIBP measurements were recorded at the arm , forearm , and ankle at 5-minute intervals .


The systolic blood pressure difference between the arm-forearm or the arm-ankle was within the 10 % range in 63 % and 29 % of measurements , and within the 20 % range in 85 % and 67 % of measurements , respectively .


The diastolic blood pressure difference between the arm-forearm or the arm-ankle was within the 10 % range in 42 % and 44 % and within the 20 % range in 67 % and 74 % of measurements , respectively .


In patients in whom the initial three NIBP measurements were within the 20 % range between the forearm and arm , 86 % of the subsequent measurements were also within that limit .


Forearm and ankle NIBP measurements are unreliable and inconsistent with NIBP measured in the arm of anesthetized children .


These alternative BP measurement sites are not reliable in accuracy ( comparison with reference `` gold '' standard ) and precision ( reproducibility ) .


To assess health-related quality of life ( QoL ) and clinical factors predicting it after tonsillectomy among adult patients with recurrent pharyngitis .


Prospective cohort design .


Tertiary referral centre .


Adults ( n = 153 ) who underwent tonsillectomy for recurrent pharyngitis .


QoL 6 months after tonsillectomy measured by the Glasgow Benefit Inventory ( GBI ) .


Factors predicting high postoperative QoL were sought using multiple linear regression analysis .


Of the 142 patients ( 93 % of all eligible ) responding to the GBI questionnaire , 94 ( 66 % ) were female ; median age was 26 years ( range 14-65 ) .


GBI Total Scores varied markedly ( range -19 to +69 ) , but on average showed improvement ( median +27 , interquartile range 18-36 ) , most evidently in the GBI Physical Health Score ( median +83 ) , after tonsillectomy .


Among routinely recorded clinical characteristics , the number of prior pharyngitis episodes , frequent throat pain , untreated dental caries and chronically infected tonsils made up the optimal subset of factors for predicting the GBI Total Score .


However , in a random sample of patients ( n = 56 ) for whom preoperative diary-based data were also available , somewhat better predictive ability was achieved based on just two diary items : number of days with throat pain and with fever during the preceding few months ( correlation coefficient , r , between observed and fitted scores improved from 0.39 to 0.55 ) .


Yet , the precision of even these predictions was still quite low .


Adult patients with recurrent pharyngitis were on average satisfied after tonsillectomy , regardless of the aetiology of the episodes .


Clinical factors rather modestly predicted which patients benefited most from the operation .


To determine the impact of supplemental zinc , vitamin A , and glutamine alone or in combination on growth , intestinal barrier function , stress and satiety-related hormones among Brazilian shantytown children with low median height-for-age z-scores .


A randomized , double-blind , placebo-controlled trial was conducted in children aged two months to nine years from the urban shanty compound community of Fortaleza , Brazil .


Demographic and anthropometric information was assessed .


The random treatment groups available for testing ( a total of 120 children ) were as follows : ( 1 ) glutamine alone , n = 38 ; ( 2 ) glutamine plus vitamin A plus zinc , n = 37 ; and a placebo ( zinc plus vitamin A vehicle ) plus glycine ( isonitrogenous to glutamine ) control treatment , n = 38 .


Leptin , adiponectin , insulin-like growth factor ( IGF-1 ) , and plasma levels of cortisol were measured with immune-enzymatic assays ; urinary lactulose/mannitol and serum amino acids were measured with high-performance liquid chromatography .


ClinicalTrials.gov : NCT00133406 .


Glutamine treatment significantly improved weight-for-height z-scores compared to the placebo-glycine control treatment .


Either glutamine alone or all nutrients combined prevented disruption of the intestinal barrier function , as measured by the percentage of lactulose urinary excretion and the lactulose : mannitol absorption ratio .


Plasma leptin was negatively correlated with plasma glutamine ( p = 0.002 ) and arginine ( p = 0.001 ) levels at baseline .


After glutamine treatment , leptin was correlated with weight-for-age ( WAZ ) and weight-for-height z-scores ( WHZ ) ( p0 .002 ) at a 4-month follow-up .


In addition , glutamine and all combined nutrients ( glutamine , vitamin A , and zinc ) improved the intestinal barrier function in these children .


Taken together , these findings reveal the benefits of glutamine alone or in combination with other gut-trophic nutrients in growing children via interactions with leptin .


Undecylenoyl phenylalanine is a novel skin-lightening agent , probably acting as - melanocyte-stimulating hormone ( - MSH ) and beta-adrenergic receptor ( - ADR ) antagonist .


The objective of this double-blind randomized comparative study was to evaluate the efficacy and safety of a preparation containing undecylenoyl phenylalanine 2 % in the topical treatment of melasma in females .


Forty female patients with melasma were randomly assigned to apply either the active preparation or the vehicle alone , twice daily for 12weeks .


Patients were evaluated monthly for efficacy and safety .


In all , 37 patients completed the study .


Of the 20 patients on active treatment , no one responded completely , but 17 ( 85 % ) had partial response .


Of them , 11 had moderate improvement and six had marked improvement .


Lightening of the lesions was evident from the first follow-up visit at 4weeks .


A statistically significant difference ( P < 0.001 ) in efficacy between the active preparation and the vehicle was documented .


Using patient assessment ratings , 80 % were extremely satisfied or satisfied with the result .


The reported side effects were minor and included erythema and itching or burning at the site of application .


Undecylenoyl phenylalanine 2 % achieved a significant lightening of melasma lesions with minimal side effects .


Older men are at risk of dying of melanoma .


To assess attendance at and clinical outcomes of clinical skin examinations ( CSEs ) in older men exposed to a video-based behavioral intervention .


This was a behavioral randomized clinical trial of a video-based intervention in men aged at least 50 years .


Between June 1 and August 31 , 2008 , men were recruited , completed baseline telephone interviews , and were than randomized to receive either a video-based intervention ( n = 469 ) or brochures only ( n = 461 ; overall response rate ,37.1 % ) and were again interviewed 7 months later ( n = 870 ; 93.5 % retention ) .


Video on skin self-examination and skin awareness and written informational materials .


The control group received written materials only .


Participants who reported a CSE were asked for the type of CSE ( skin spot , partial body , or whole body ) , who initiated it , whether the physician noted any suspicious lesions , and , if so , how lesions were managed .


Physicians completed a case report form that included the type of CSE , who initiated it , the number of suspicious lesions detected , how lesions were managed ( excision , nonsurgical treatment , monitoring , or referral ) , and pathology reports after lesion excision or biopsy .


Overall , 540 of 870 men ( 62.1 % ) self-reported a CSE since receiving intervention materials , and 321 of 540 ( 59.4 % ) consented for their physician to provide medical information ( received for 266 of 321 [ 82.9 % ] ) .


Attendance of any CSE was similar between groups ( intervention group , 246 of 436 [ 56.4 % ] ; control group , 229 of 434 [ 52.8 % ] ) , but men in the intervention group were more likely to self-report a whole-body CSE ( 154 of 436 [ 35.3 % ] vs 118 of 434 [ 27.2 % ] for control group ; P = .01 ) .


Two melanomas , 29 squamous cell carcinomas , and 38 basal cell carcinomas were diagnosed , with a higher proportion of malignant lesions in the intervention group ( 60.0 % vs 40.0 % for controls ; P = .03 ) .


Baseline attitudes , behaviors , and skin cancer history were associated with higher odds of CSE and skin cancer diagnosis .


A video-based intervention may increase whole-body CSE and skin cancer diagnosis in older men .


anzctr.org.au Identifier : ACTRN12608000384358 .


The results of conservative treatment of knee osteoarthritis ( OA ) are generally evaluated in epidemiological studies with clinical outcome measures as primary outcomes .


Biomechanical evaluation of orthoses shows that there are potentially beneficial biomechanical changes to joint loading ; however , evaluation in relation to clinical outcome measures in longitudinal studies is needed .


We asked ( 1 ) is there an immediate effect on gait in patients using a laterally wedged insole or valgus knee brace ; ( 2 ) is there a late ( 6 weeks ) effect ; and ( 3 ) is there a difference between subgroups within each group with respect to patient compliance , body mass index , and OA status ?


This was a secondary analysis of data from a previous randomized controlled trial of patients with early medial knee OA .


A total of 91 patients were enrolled in that trial , and 73 ( 80 % ) completed it after 6 months .


Of the enrolled patients , 80 ( 88 % ) met prespecified inclusion criteria for analysis in the present study .


The patients were randomized to an insole or brace .


Gait was analyzed with and without wearing the orthosis ( insole or brace ) at baseline and after 6 weeks .


Measurements were taken of the knee adduction moment , ground reaction force , moment arm , walking speed , and toe-out angle .


Data were analyzed with regression analyses based on an intention-to-treat principle .


A mean reduction of 4 % ( 10 ) ( 95 % confidence interval [ CI ] , -0.147 to -0.03 , p = 0.003 ) of the peak knee adduction moment and 4 % ( 13 ) ( 95 % CI , -0.009 to -0.001 , p = 0.01 ) of the moment arm at baseline was observed in the insole group when walking with an insole was compared with walking without an insole .


A mean reduction of 1 % ( 10 ) ( 95 % CI , -0.002 to -0.001 , p = 0.001 ) of the peak knee adduction moment and no reduction of the moment arm were measured after 6 weeks .


No reduction of knee adduction moment , moment arm , or ground reaction force was seen in the brace group at baseline and after 6 weeks .


Subgroup analysis showed no differences in biomechanical effect for obesity , stage of OA , and whether patients showed a clinical response to the treatment .


Laterally wedged insoles unload the medial compartment only at baseline in patients with varus alignment and by an amount that might not be clinically important .


No biomechanical alteration was seen after 6 weeks of wearing the insole .


Valgus brace therapy did not result in any biomechanical alteration .


Taken together , this study does not show a clinically relevant biomechanical effect of insole and brace therapy in patients with varus medial knee OA .


Level I , therapeutic study .


See Instructions for Authors for a complete description of levels of evidence .


In patients with severe aortic stenosis ( AS ) , treatment with angiotensin-converting enzyme inhibitors has previously been considered contraindicated .


However , there is a lack of clinical evidence to confirm these potential hemodynamic risks and benefits .


Forty-four patients with severe AS ( aortic valve area < 1 cm ( 2 ) ) were randomized to treatment with trandolapril 22 mg daily/placebo ( 1:1 ) .


Right heart catheterization and echocardiography were performed at rest and during exercise at baseline and on day 3 .


Follow-up was performed before valve replacement or after a maximum of 8 weeks , when exercise echocardiography was repeated .


Compared with placebo , systolic blood pressure and systemic arterial compliance significantly changed at day 3 ( -14 11 vs -5 13 mm Hg , P = .02 , and 0.08 0.16 vs -0.05 0.86 mL/m ( 2 ) per mm Hg , P = .03 , respectively ) .


Changes in left ventricular end systolic volume ( LVESV ) was nonsignificant ( -8 9 vs -3 11 mL , P = .17 ) .


At a median of 49 days of follow-up , changes in LVESV and N-terminal pro-brain natriuretic peptide were even lower revealing significant differences between the groups ( -7.8 2.6 vs -0.5 2.5 mL , P = .04 , and -19 7 vs 0.8 6 pmol/L , P = .04 , respectively ) .


No episodes of symptomatic hypotension were noted , and other hemodynamic parameters remained unchanged .


Angiotensin-converting enzyme inhibition in severe AS caused a decrease in LVESV and N-terminal pro-brain natriuretic peptide with other hemodynamic parameters preserved both at rest and during exercise implying hemodynamic improvement with left ventricular unloading .


Alternative cerebral fuels are reputed to provide neuroprotection during hypoglycaemia , particularly in breastfed babies .


We measured concentrations of alternative cerebral fuels in hypoglycaemic babies in the first 48h .


Babies were 35weeks , 48h old and at risk of hypoglycaemia ( infant of diabetic , preterm , small or large ) .


Plasma glucose , - hydroxybutyrate , lactate and insulin concentrations were measured in babies who had been hypoglycaemic ( < 2.6 mM ) for > 1h .


Samples were taken from 35 hypoglycaemic babies at 3.7 ; 1.8-39 .6 ( median ; range ) hours after birth .


Concentrations of glucose and - hydroxybutyrate were low ( 2.03 ; 0.19-3 .39 mM and 0.06 ; 0.00-1 .20 mM ) , but lactate concentrations varied widely ( 3.06 ; 0.02-7 .96 mM ) .


Infants of diabetics had lower - hydroxybutyrate and higher insulin concentrations , but mode of feeding did not influence plasma concentrations of alternative cerebral fuels .


Hypoglycaemic babies within the first 48h after birth are unlikely to receive neuroprotection from ketones .


However , lactate may provide an alternative cerebral fuel for many .


Lactate , rather than ketones , may provide alternative cerebral fuel in hypoglycaemic newborns .


ACTRN12608000623392 .


There is a wide variability in measurement methodology of physical activity .


This study investigated the effect of different analysis techniques on the statistical power of physical activity outcomes after pulmonary rehabilitation .


Physical activity was measured with an activity monitor armband in 57 patients with COPD ( mean SD age , 66 7 years ; FEV1 , 46 17 % predicted ) before and after 3 months of pulmonary rehabilitation .


The choice of the outcome ( daily number of steps [ STEPS ] , time spent in at least moderate physical activity [ TMA ] , mean metabolic equivalents of task level [ METS ] , and activity time [ ACT ] ) , impact of weekends , number of days of assessment , postprocessing techniques , and influence of duration of daylight time ( DT ) on the sample size to achieve a power of 0.8 were investigated .


The STEPS and ACT ( 1.6-2 .3 metabolic equivalents of task ) were the most sensitive outcomes .


Excluding weekends decreased the sample size for STEPS ( 83 vs 56 ) , TMA ( 160 vs 148 ) , and METS ( 251 vs 207 ) .


Using 4 weekdays ( STEPS and TMA ) or 5 weekdays ( METS ) rendered the lowest sample size .


Excluding days with < 8 h wearing time reduced the sample size for STEPS ( 56 vs 51 ) .


Differences in DT were an important confounder .


Changes in physical activity following pulmonary rehabilitation are best measured for 4 weekdays , including only days with at least 8 h of wearing time ( during waking hours ) and considering the difference in DT as a covariate in the analysis .


ClinicalTrials.gov ; No. : NCT00948623 ; URL : www.clinicaltrials.gov .


While studies have looked into the effects of Maitland mobilization on symptom relief , to date , no work has specifically looked at the effects of Mulligan mobilization .


The objective of this work was to compare the effectiveness of Maitland and Mulligan 's mobilization and exercises on pain response , range of motion ( ROM ) and functional ability in patients with mechanical neck pain .


A total sample of 60 subjects ( 21-45 years of age ) with complaints of insidious onset of mechanical pain that has lasted for less than 12 weeks and reduced ROM were randomly assigned to : group I - Maitland mobilization and exercises ; group - II Mulligan mobilization and exercises ; and group-III exercises only , and assessed for dependent variables by a blinded examiner .


Post measurement readings revealed statistical significance with time ( p < 0.00 ) and no significance between groups ( p > 0.05 ) indicating no group is superior to another after treatment and at follow-up .


The effect sizes between the treatment groups were small .


Our results showed that manual therapy interventions were no better than supervised exercises in reducing pain , improving ROM and neck disability .


Waterpipe use has increased dramatically in the Middle East and other parts of the world .


Many users exhibit signs of dependence , including withdrawal and difficulty quitting , but there is no evidence base to guide cessation efforts .


We developed a behavioral cessation program for willing-to-quit waterpipe users , and evaluated its feasibility and efficacy in a pilot , two arm , parallel group , randomized , open label trial in Aleppo , Syria .


Fifty adults who smoked waterpipe 3 times per week in the last year , did not smoke cigarettes , and were interested in quitting were randomized to receive either brief ( 1 in-person session and 3 phone calls ) or intensive ( 3 in-person sessions and 5 phone calls ) behavioral cessation treatment delivered by a trained physician in a clinical setting .


The primary efficacy end point of the developed interventions was prolonged abstinence at three months post-quit day , assessed by self-report and exhaled carbon monoxide levels of < 10 ppm .


Secondary end points were 7 day point-prevalent abstinence and adherence to treatment .


Thirty percent of participants were fully adherent to treatment , which did not vary by treatment group .


The proportions of participants in the brief and intensive interventions with prolonged abstinence at the 3-month assessment were 30.4 % and 44.4 % , respectively .


Previous success in quitting ( OR = 3.57 ; 95 % CI = 1.03-12 .43 ) predicted cessation .


Higher baseline readiness to quit , more confidence in quitting , and being unemployed predicted a better adherence to treatment ( all p-values < 0.05 ) .


Brief behavioral cessation treatment for waterpipe users appears to be feasible and effective .


Young gay and bisexual men ( YGBM ) are disproportionally at risk of HIV infection due to sexual risk behaviors , which are often exacerbated by recreational drug use .


However , there have been no evidence-based interventions targeting substance-using YGBM .


This study was designed to test a brief motivational interviewing ( MI ) intervention to reduce both risky sex and drug use among HIV-negative YGBM .


A total of 143 non-treatment-seeking YGBM ( ages 18-29 years ) who reported recent unprotected anal intercourse ( UAI ) and recreational drug use were randomized to 4 sessions of MI or 4 sessions of content-matched education .


Participants were followed every 3 months for 1 year , and behavior change was examined across conditions and time for aggregated and day-level drug use and UAI .


Regardless of condition , participants reported significant reductions in UAI and substance use over time .


However , YGBM in the MI condition were 18 % less likely to use drugs and 24 % less likely to engage in UAI than YGBM in the education condition .


The results support the utility of MI , compared with a content-matched education condition , to significantly reduce both UAI and drug use among YGBM .


Interventions may benefit from an emphasis on substance use reductions , which might indirectly lead to less frequent UAI .


Future research efforts should examine whether this type of brief MI intervention is effective when delivered by clinic or community settings utilized by YGBM .


Data regarding immunomodulatory effects of parenteral n-3 fatty acids in sepsis are conflicting .


In this study , the effect of administration of parenteral n-3 fatty acids on markers of brain injury , incidence of sepsis-associated delirium , and inflammatory mediators in septic patients was investigated .


Fifty patients with sepsis were randomized to receive either 2 ml/kg/day of a lipid emulsion containing highly refined fish oil ( equivalent to n-3 fatty acids 0.12 mg/kg/day ) during 7 days after admission to the intensive care unit or standard treatment .


Markers of brain injury and inflammatory mediators were measured on days 1 , 2 , 3 and 7 .


Assessment for sepsis-associated delirium was performed daily .


The primary outcome was the difference in S-100 from baseline to peak level between both the intervention and the control group , compared by t-test .


Changes of all markers over time were explored in both groups , fitting a generalized estimating equations model .


Mean difference in change of S-100 from baseline to peak level was 0.34 ( 95 % CI : -0.18 -0.85 ) between the intervention and control group , respectively ( P = 0.19 ) .


We found no difference in plasma levels of S-100 , neuron-specific enolase , interleukin ( IL ) -6 , IL-8 , IL-10 , and C-reactive protein between groups over time .


Incidence of sepsis-associated delirium was 75 % in the intervention and 71 % in the control groups ( risk difference 4 % , 95 % CI -24 -31 % , P = 0.796 ) .


Administration of n-3 fatty acids did not affect markers of brain injury , incidence of sepsis-associated delirium , and inflammatory mediators in septic patients .


To assess whether low-dose contrast medium and low-tube voltage computed tomography ( CT ) venography can be used for clinical diagnosis .


This prospective study included 63 patients who were randomized into 3 groups and administered contrast medium of either 600 , 500 , or 400 mg of iodine per kilogram ( mgI/kg ) .


All patients underwent dual-energy CT at either 80 or 135 kilovolt ( peak ) ( kV [ p ] ) .


Control images ( 120 kV [ p ] ) were acquired from them and were compared with 80-kV ( p ) images .


The mean CT values of the bilateral femoral and popliteal veins were compared .


The mean CT values of the 80-kV ( p ) images were significantly higher than 120-kV ( p ) images for all doses .


No significant difference was observed for the CT values of the 80-kV ( p ) images with the 400-mgI/kg dose and the control images ( 600 mgI/kg at 120 kV [ p ] ) .


Low tube voltage enabled a reduction of contrast medium to 400 mgI/kg for CT venography .


The dipeptidyl-peptidase-IV ( DPP-4 ) inhibitors , including sitagliptin , are used for the treatment of type 2 diabetes mellitus ( T2DM ) .


Adiponectin , an adipocyte-derived circulating protein , has anti-atherosclerotic and anti-diabetic properties and is effectively elevated in bloodstream by thiazolidinediones , an insulin sensitizer .


However , the effect of sitagliptin treatment on serum adiponectin level in T2DM has not fully elucidated in Japanese T2DM patients .


The aim of the present study was to examine the effect of sitagliptin treatment on serum adiponectin levels in T2DM subjects .


Twenty-six consecutive Japanese T2DM outpatients were recruited between April 2011 and March 2013 , and randomized into the control ( conventional treatment , n = 10 ) group and sitagliptin treatment group ( n = 16 ) .


Serum adiponectin was measured by enzyme-linked immunosorbent assay .


Indices of glycemic control , such as hemoglobin A1c , glycated albumin , and 1.5-anhydro-D-glucitol , were significantly improved after the three-month treatment in both the control and sitagliptin groups .


Serum adiponectin level was significantly increased in sitagliptin group from 6.70.8 to 7.41.0 g/mL without change of body mass index ( p = 0.034 ) , while serum adiponectin level was not altered in the control group ( p = 0.601 ) .


In Japanese T2DM patients , serum adiponectin level was elevated by three-month treatment with sitagliptin without change of body weight .


UMIN000004721 .


In this study , Increasing Viral Testing in the Emergency Department ( InVITED ) , the authors investigated if a brief intervention about human immunodeficiency virus ( HIV ) and hepatitis C virus ( HCV ) risk-taking behaviors and drug use and misuse in addition to a self-administered risk assessment , compared to a self-administered risk assessment alone , increased uptake of combined screening for HIV and HCV , self-perception of HIV/HCV risk , and impacted beliefs and opinions on HIV/HCV screening .


InVITED was a randomized , controlled trial conducted at two urban emergency departments ( EDs ) from February 2011 to March 2012 .


ED patients who self-reported drug use within the past 3 months were invited to enroll .


Drug misuse severity and need for a brief or more intensive intervention was assessed using the Alcohol , Smoking and Substance Involvement Screening Test ( ASSIST ) .


Participants were randomly assigned to one of two study arms : a self-administered HIV/HCV risk assessment alone ( control arm ) or the assessment plus a brief intervention about their drug misuse and screening for HIV/HCV ( intervention arm ) .


Beliefs on the value of combined HIV/HCV screening , self-perception of HIV/HCV risk , and opinions on HIV/HCV screening in the ED were measured in both study arms before the HIV/HCV risk assessment ( pre ) , after the assessment in the control arm , and after the brief intervention in the intervention arm ( post ) .


Participants in both study arms were offered free combined rapid HIV/HCV screening .


Uptake of screening was compared by study arm .


Multivariable logistic regression models were used to evaluate factors related to uptake of screening .


Of the 395 participants in the study , the median age was 28 years ( interquartile range [ IQR ] = 23 to 38 years ) , 44.8 % were female , 82.3 % had ever been tested for HIV , and 67.3 % had ever been tested for HCV .


Uptake of combined rapid HIV/HCV screening was nearly identical by study arm ( 64.5 % vs. 65.2 % ; = -0.7 % ; 95 % confidence interval [ CI ] = -10.1 % to 8.7 % ) .


Of the 256 screened , none had reactive HIV antibody tests , but seven ( 2.7 % ) had reactive HCV antibody tests .


Multivariable logistic regression analysis results indicated that uptake of screening was not related to study arm assignment , total ASSIST drug scores , need for an intervention for drug misuse , or HIV/HCV sexual risk assessment scores .


However , uptake of screening was greater among participants who indicated placing a higher value on combined rapid HIV/HCV screening for themselves and all ED patients and those with higher levels of perceived HIV/HCV risk .


Uptake of combined rapid HIV/HCV screening was not related to changes in beliefs regarding the value of combined HIV/HCV screening or self-perceived HIV/HCV risk ( post - vs. pre-risk assessment with or without a brief intervention ) .


Opinions regarding the ED as a venue for combined rapid HIV/HCV screening were not related to uptake of screening .


Uptake of combined rapid HIV/HCV screening is high and considered valuable among drug using and misusing ED patients with little concern about the ED as a screening venue .


The brief intervention investigated in this study does not appear to change beliefs regarding screening , self-perceived risk , or uptake of screening for HIV/HCV in this population .


Initial beliefs regarding the value of screening and self-perceived risk for these infections predict uptake of screening .


To investigate the effects of a single instillation of hypotonic 0.18 % sodium hyaluronate artificial tears on wavefront aberrations in dry eye patients .


Fifty patients with dry eye were recruited into this single-center , prospective , double-masked , randomized controlled trial .


Patients were randomly assigned to receive one drop of preservative-free , hypotonic 0.18 % sodium hyaluronate ( treatment ) in one eye and one drop of sterile 0.9 % sodium chloride solution ( control ) in the other eye .


Ocular aberrations evaluated by a Hartmann-Shack aberrometer and severity of dry eye symptoms graded by a questionnaire ( at baseline , 1 , 10 , 30 , 60 , and 120 minutes after instillation ) were the main outcome measures .


After a single instillation of one drop of the allocated eye drops , there were no statistically significant differences between the treatment and control groups in total higher-order aberrations , coma , and spherical aberrations during the study period ( p = 0.40 , 0.57 , and 0.16 , respectively ) .


Although a statistically significant ( p = 0.04 ) decrease from baseline in spherical aberrations was noted in the treatment group at 1 minute following instillation , it gradually increased back to baseline values at later time points .


A statistically significant diminishment of dry eye symptoms compared with the placebo was reported at all time points by the treatment group ( p < 0.001 ) .


A single instillation of hypotonic 0.18 % sodium hyaluronate eye drops is safe and effective in alleviating subjective dry eye symptoms ; however , it does not appear to affect higher-order aberrations in moderate to severe dry eye patients .


We described the change in visual acuity experienced by eyes successfully treated for bacterial keratitis .


This was a prospective cohort study of a subset of study participants who had previously enrolled in the Steroids for Corneal Ulcers Trial ( SCUT ) .


All study participants had been diagnosed with culture-proven bacterial keratitis before enrollment in SCUT and subsequently were randomized to adjunctive topical corticosteroids or placebo .


During SCUT , we monitored study participants at enrollment , 3 weeks , 3 months , and 12 months .


We invited a subset to complete a comprehensive eye examination approximately 4 years after enrollment in SCUT .


Certified refractionists assessed best spectacle-corrected visual acuity ( BSCVA ) using the same protocol at each study visit .


We examined 50 SCUT participants at 4 years after enrollment .


Among those in this cohort , mean logMAR BSCVA at enrollment was 0.85 ( Snellen equivalent , 20/160 ; 95 % confidence interval [ CI ] , 0.71-0 .99 ) .


On average , visual acuity improved by 2.9 logMAR lines from enrollment to 3 weeks ( P < 0.001 ) , 1.2 lines from 3 weeks to 3 months ( P = 0.002 ) , and 0.8 lines from 3 to 12 months ( P = 0.01 ) .


The BSCVA did not change significantly between 12 months and 4 years ( 0.04-line improvement , P = 0.88 ) .


After controlling for visual acuity at enrollment , BSCVA was not significantly different between the corticosteroid and placebo groups at 4 years ( P = 0.53 ) .


Cases of bacterial keratitis may continue to demonstrate improvements in visual acuity up to 12 months following diagnosis , but further improvements are unlikely .


These findings may guide the appropriate timing of surgical intervention in these patients .


( ClinicalTrials.gov number , NCT00324168 . )


The analgesic effect of the adductor canal block ( ACB ) after knee surgery has been evaluated in a number of trials .


We hypothesized that the ACB would provide substantial pain relief to patients responding with moderate to severe pain after arthroscopic knee surgery .


Fifty subjects with moderate to severe pain after arthroscopic knee surgery were enrolled in this placebo-controlled , blinded trial .


All subjects received two ACBs ; an initial ACB with either 30ml ropivacaine 7.5 mg/ml ( n = 25 ) ( R group ) or saline ( n = 25 ) ( C group ) and after 45min a second ACB with the opposite study medication , according to randomization .


Primary outcome was pain during 45 degrees active flexion of the knee at 45min after the first block , assessed on a 0-100mm visual analogue scale .


Secondary outcome measures were : pain at rest and during flexion of the knee , worst pain experienced during a 5-m walk , patient 's evaluation of muscle strength during walk , and amount of sufentanil administered during the 90-min study period .


Regarding primary outcome , mean pain score difference between groups was 34 ( 95 % CI : 25 to 44 ) mm , P < 0.001 , in favour of the R group .


At rest , mean pain score difference was 32 ( 23 to 41 ) mm , P < 0.001 , and during walk : 21 ( 6 to 36 ) mm , P = 0.01 in favour of the R group .


There were no differences between groups regarding other secondary outcome measures .


The ACB is a relevant option for patients with moderate to severe pain after arthroscopic knee surgery .


To prospectively evaluate if training with direct feedback improves grading accuracy of inexperienced readers for Crohn 's disease activity on magnetic resonance imaging ( MRI ) .


Thirty-one inexperienced readers assessed 25 cases as a baseline set .


Subsequently , all readers received training and assessed 100 cases with direct feedback per case , randomly assigned to four sets of 25 cases .


The cases in set 4 were identical to the baseline set .


Grading accuracy , understaging , overstaging , mean reading times and confidence scores ( scale 0-10 ) were compared between baseline and set 4 , and between the four consecutive sets with feedback .


Proportions of grading accuracy , understaging and overstaging per set were compared using logistic regression analyses .


Mean reading times and confidence scores were compared by t-tests .


Grading accuracy increased from 66 % ( 95 % CI , 56-74 % ) at baseline to 75 % ( 95 % CI , 66-81 % ) in set 4 ( P = 0.003 ) .


Understaging decreased from 15 % ( 95 % CI , 9-23 % ) to 7 % ( 95 % CI , 3-14 % ) ( P < 0.001 ) .


Overstaging did not change significantly ( 20 % vs 19 % ) .


Mean reading time decreased from 6 min 37 s to 4 min 35 s ( P < 0.001 ) .


Mean confidence increased from 6.90 to 7.65 ( P < 0.001 ) .


During training , overall grading accuracy , understaging , mean reading times and confidence scores improved gradually .


Inexperienced readers need training with at least 100 cases to achieve the literature reported grading accuracy of 75 % .


Most radiologists have limited experience of grading Crohn 's disease activity on MRI .


Inexperienced readers need training in the MRI assessment of Crohn 's disease .


Grading accuracy , understaging , reading time and confidence scores improved during training .


Radiologists and residents show similar accuracy in grading Crohn 's disease .


After 100 cases , grading accuracy can be reached as reported in the literature .


The aim of this study was to assess the various doses of oral oxybutynin on cardiac autonomic modulation by measuring short-term heart rate variability ( HRV ) indexes during supine rest position .


Eight male healthy subjects ( 20-23years ) participated in the double-blind crossover randomized study .


The single dose of oxybutynin ( 2.5 , 5 and 10mg ) or placebo was given to the volunteers in four sessions within 5-day intervals .


Before and minutes of 30 , 60 , 90 and 120 after administration , lead II electrocardiogram ( ECG ) was recorded for 5min .


ECG extracted RR intervals data became the base of the calculation of time domain and frequency domain HRV parameters , which indicate cardiac autonomic activity .


Statistical analysis was done by using the nonparametric Wilcoxon and Kruskal-Wallis tests .


The data analysis has revealed that MNN ( P < 0.001 ) , SDNN ( P < 0.05 ) , PNN50 % ( P < 0.01 ) , RMSSD ( P < 0.001 ) , HFnu ( P < 0.05 ) and LF/HF ratio ( P < 0.05 ) values were significantly increased relative to baseline at various time points in all the groups except in placebo group .


LFnu ( P < 0.05 ) values were significantly increased relative to baseline at various time points in all the groups except in placebo group .


Our findings have revealed that acute consumption of 2.5 , 5 and 10mg oxybutynin ( an anticholinergic compound ) in the juvenile healthy male subjects produces a cholinergic effect according to time and frequency domain of HRV indexes .


Annual seasonal influenza epidemics are particularly dangerous for the very young , the elderly and chronically ill individuals , in whom infection can cause severe morbidity , hospitalization and death .


Existing , nonadjuvanted influenza vaccines exhibit a suboptimal immunogenicity and efficacy in immunologically naive subjects such as young children .


This phase II , randomized clinical trial was conducted to evaluate the antibody and cell-mediated responses to a trivalent influenza vaccine administered without adjuvant ( TIV ) or adjuvanted with MF59 ( ATIV ) in previously nonvaccinated children less than 3 years of age .


The MF59-adjuvanted vaccine was well tolerated , and induced higher titers of hemagglutination inhibition antibodies able to recognize strains different from the one used in the vaccine ( heterovariant ) than TIV .


The presence of the adjuvant MF59 induced a larger expansion of vaccine-specific CD4 T cells .


Interestingly , the adjuvant MF59 did not modify the cytokine profile of the elicited T cells , characterized by the production of IL-2 and TNF - , and did not bias the response toward either Th1 or Th2 .


The advantage of ATIV over TIV was more pronounced for the virus strains that had not circulated in the years that preceded this study and for the heterovariant strains .


These data highlight the relevant role played by the oil-in-water adjuvant MF59 in enhancing the immunogenicity of inactivated influenza vaccines in immunologically naive individuals .


To study the clinical efficacy of traditional Chinese medicine ( TCM ) intervention `` tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment '' ( `` TTK '' ) for treating liver failure due to chronic hepatitis B.


We designed the study as a randomized controlled clinical trial .


Registration number of Chinese Clinical Trial Registry is ChiCTR-TRC-12002961 .


A total of 144 patients with liver failure due to infection with chronic hepatitis B virus were enrolled in this randomized controlled clinical study .


Participants were randomly assigned to the following three groups : ( 1 ) a modern medicine control group ( MMC group , 36 patients ) ; ( 2 ) a `` tonifying qi and detoxification '' ( `` TQD '' ) group ( 72 patients ) ; and ( 3 ) a `` tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment '' ( `` TTK '' ) group ( 36 patients ) .


Patients in the MMC group received general internal medicine treatment ; patients in the `` TQD '' group were given a TCM formula `` tonifying qi and detoxification '' and general internal medicine treatment ; patients in the `` TTK '' group were given a TCM formula of `` TTK '' and general internal medicine treatment .


All participants were treated for 8 wk and then followed at 48 wk following their final treatment .


The primary efficacy end point was the patient fatality rate in each group .


Measurements of various virological and biochemical indicators served as secondary endpoints .


The one-way analysis of variance and the t-test were used to compare patient outcomes in the different treatment groups .


At the 48-wk post-treatment time point , the patient fatality rates in the MMC , `` TQD '' , and `` TTK '' groups were 51.61 % , 35.38 % , and 16.67 % , respectively , and the differences between groups were statistically significant ( P < 0.05 ) .


However , there were no significant differences in the levels of hepatitis B virus DNA or prothrombin activity among the three groups ( P > 0.05 ) .


Patients in the `` TTK '' group had significantly higher levels of serum total bilirubin compared to MMC subjects ( 339.40 mol/L 270.09 mol/L vs 176.13 mol/L 185.70 mol/L , P = 0.014 ) .


Serum albumin levels were significantly increased in both the `` TQD '' group and `` TTK '' group as compared with the MMC group ( 31.30 g/L 4.77 g/L , 30.72 g/L 2.89 g/L vs 28.57 g/L 4.56 g/L , P < 0.05 ) .


There were no significant differences in levels of alanine transaminase among the three groups ( P > 0.05 ) .


Safety data showed that there was one case of stomachache in the `` TQD '' group and one case of gastrointestinal side effect in the `` TTK '' group .


Treatment with `` TTK '' improved the survival rates of patients with liver failure due to chronic hepatitis B. Additionally , liver tissue was regenerated and liver function was restored .


Drug therapy problems , adverse drug events ( ADEs ) , and symptom burden are high among adults with disabilities .


To compare the effects of a modified medication therapy management ( MTM ) program within a self-efficacy workshop versus the workshop alone or usual care on symptom burden among adults with activity limitations .


Three-group randomized controlled trial among adults ( age 40 and older ) with self-reported activity limitations in community practice .


8 weekly Living Well With a Disability ( LWD ) 2-hour workshop sessions with and without a collaborative medication management ( CMM ) module .


mean number of moderate to very severe symptoms from a list of 11 physical and mental symptoms .


Process measures : changes in medication regimens and self-reported ADEs .


general linear mixed models ( continuous outcomes ) and generalized estimating equations ( categorical outcomes ) .


Participants had high symptom burden , low physical health , and took many medications .


There was a significant increase in ADE reporting in the LWD + CMM group relative to the other 2 groups ( Study group Time P = .014 ) , and there were significantly more changes in medication regimens in the LWD + CMM group ( P = .013 LWD only vs LWD + CMM ) .


The oldest third of participants had significantly fewer mean symptoms but received more intense CMM .


There was no difference between the LWD-only , LWD + CMM , and usual care groups in symptom burden over time .


Pharmacist MTM practices and MTM guidelines may need to be modified to affect symptom burden in a population with physical activity limitations .


In both dementia with Lewy bodies ( DLB ) and Parkinson 's disease dementia ( PDD ) , attentional dysfunction is a core clinical feature together with disrupted episodic memory .


This study evaluated the cognitive effects of memantine in DLB and PDD using automated tests of attention and episodic memory .


A randomised double-blind , placebo-controlled , 24-week three centre trial of memantine ( 20mg/day ) was conducted in which tests of attention ( simple and choice reaction time ) and word recognition ( immediate and delayed ) from the CDR System were administered prior to dosing and again at 12 and 24weeks .


Although other results from this study have been published , the data from the CDR System tests were not included and are presented here for the first time .


Data were available for 51 patients ( 21 DLB and 30 PDD ) .


In both populations , memantine produced statistically significant medium to large effect sized improvements to choice reaction time , immediate and delayed word recognition .


These are the first substantial improvements on cognitive tests of attention and episodic recognition memory identified with memantine in either DLB or PDD .


This Phase IV , open-label , multicentre , randomized study ( MEnTOR ) compared two low-dose recombinant human follicle-stimulating hormone ( r-hFSH ) protocols for ovulation induction .


This study was conducted in six Middle Eastern countries between March 2009 and March 2011 .


Eligible women ( 18-37 years ) , with World Health Organization Group II anovulatory infertility , were randomized to receive r-hFSH ( starting daily dose : 75 IU ) as a chronic low-dose ( CLD ) ( 37.5 IU dose increase on Day 14 ) or low-dose ( LD ) ( 37.5 IU dose increase on Day 7 ) protocol if no follicles were 10 mm .


The maximum r-hFSH daily dose permitted was 225 IU/day .


The total length of ovarian stimulation could not exceed 35 days , unless ultrasound assessment suggested imminent follicular growth and maturation .


Patients underwent only one treatment cycle .


Primary endpoint : incidence of mono-follicular development .


Secondary endpoints included : stimulation duration and rates of bi-follicular development ; human chorionic gonadotrophin administration rate ; clinical pregnancy ; and cycle cancellation ( owing to inadequate response ) .


Adverse events ( AEs ) were recorded .


The primary efficacy analysis was performed using data from all patients who received at least one dose of correct study medication , had at least one efficacy assessment , and no protocol violations at treatment start ( CLD group , n = 122 ; LD group , n = 125 ) .


Mono-follicular development rates ( primary endpoint ) were similar in both groups ( CLD : 56.6 % [ 69/122 ] versus LD : 55.2 % [ 69/125 ] , p = 0.93 ; primary efficacy analysis population ) .


Similarly , there were no significant differences between groups in bi-follicular development , clinical pregnancy or cycle cancellation ( inadequate response ) rates .


In patients who received human chorionic gonadotrophin injections , the mean duration of stimulation was 13.7 days in the CLD group and 12.9 days in the LD group .


Clinical pregnancy rates for those patients who received an hCG injection were similar in both groups ( CLD : 20.2 % [ 19/94 ] versus LD : 19.8 % [ 18/91 ] , p = 0.94 ; primary efficacy analysis population ) .


Most AEs were mild in severity .


Only one case of ovarian hyperstimulation syndrome was reported ( mild ; CLD group ) .


Efficacy and safety outcomes were similar for the two protocols .


Human immunodeficiency virus ( HIV ) and malaria during pregnancy cause substantial perinatal mortality .


As co-trimoxazole ( CMX ) protects children and HIV-positive adults against malaria , we compared the effectiveness of daily CMX with sulfadoxine-pyrimethamine intermittent preventive treatment ( IPT-SP ) on malaria risk in HIV-positive pregnant women in a Plasmodium falciparum-endemic African area .


From January 2009 to April 2011 , we included in a randomized noninferiority trial all HIV type 1-infected pregnant women ( 28 weeks ' gestation , CD4 count 200 cells/L , hemoglobin level 7 g/L ) in 19 health centers in Togo .


Women were randomly assigned to daily 800 mg/160 mg CMX , or IPT-SP .


The primary outcome was the proportion of malaria-free pregnancies .


Other outcomes included malaria incidence , parasitemia , placental malaria , anemia , and infants ' birth weight .


Of 264 women randomly assigned to the CMX or IPT-SP group , 126 of 132 and 124 of 132 , respectively , were included in the analysis .


There were 33 confirmed cases of clinical malaria among 31 women in the CMX group , and 19 among 19 women in the IPT-SP group .


Ninety-five of 126 ( 75.4 % ) women in the CMX group and 105 of 124 ( 84.7 % ) in the IPT-SP group remained malaria-free during their pregnancy ( difference , 9.3 % ; 95 % confidence interval [ CI ] , -.53 to 19.1 , not meeting the predefined noninferiority criterion ) .


The incidence rate in intention-to-treat analysis was 108.8 malaria episodes per 100 person-years in CMX ( 95 % CI , 105.4-112 .2 ) and 90.1 in IPT-SP ( 95 % CI , 86.8-93 .4 ) ( not significant ) .


Prevalence of parasitemia was 16.7 % in the CMX group vs 28 % in the IPT-SP group ( P = .02 ) .


Histology revealed 20.3 % placental malaria in the CMX group vs. 24.6 % in the IPT-SP group ( not significant ) .


Grade 3-4 anemia was more frequent in the CMX group ( 10 % vs 4 % ; P = .008 ) .


No pregnant women died .


Median birth weight was similar .


Daily CMX was not noninferior to IPT-SP for preventing maternal malaria but safe and at least similar regarding parasitemia or placental malaria and birth outcomes .


Clinical Trials Registration ISRCTN98835811 .


Tympanostomy with or without adenoidectomy is effective in preventing recurrences of acute otitis media ( RAOM ) , but little is known about the effect of these operations on the quality of life ( QOL ) .


We evaluated the efficacy of insertion of tympanostomy tubes with and without adenoidectomy for improving QOL in young children in a controlled , randomized trial .


QOL was evaluated in the 159 children aged 10 months to 2 years participating in our larger study in which children with RAOM were randomly assigned to receive tympanostomy tubes , tympanostomy tubes with adenoidectomy or neither .


The caregiver of the child completed otitis media-specific QOL questionnaires ( Otitis Media-6 ) at entry and after 4 months and 12 months of follow up .


Scores on the global ear-related QOL and the subsets of caregiver concern , emotional distress and physical suffering in the questionnaires improved with time during the follow up , but the groups did not differ from each other .


QOL in children with RAOM improves with time when the subjects are closely followed .


Tympanostomy with adenoidectomy does not provide any additional QOL benefit for children with RAOM , even though these operations are effective in preventing further otitis media episodes .


To evaluate risk factors for recurrent events in patients enrolled in the SteFlux ( Superficial Thromboembolism Fluxum ) clinical trial which compared different doses and duration of low molecular weight heparin ( parnaparin ) for superficial vein thrombosis ( SVT ) .


Outpatients with acute SVT of at least 4 cm in length of the internal or external saphenous veins or their collaterals were randomized in a double blind fashion to receive either parnaparin 8500 UI aXa od for ten days followed by placebo for 20 days or 8500 UI aXa od for ten days followed by 6400 UI aXa od for 20 days or 4250 UI aXa od for 30 days .


Outcomes were the composite of symptomatic and asymptomatic deep vein thrombosis , pulmonary embolism and SVT recurrence or extension in the first 30 + / -3 days with a 60 + / -3 day follow-up .


98 outcomes ( 14.7 % ) were recorded during 93 days among 664 patients ( M/F : 246/418 , mean age 65 ) .


After correction for treatment , outcomes during 33 days were associated with previous venous thromboembolism ( VTE ) and/or SVT and/or family history of VTE ( odds ratio-OR : 2.5 ; 95 % confidence interval - CI : 1.4-4 .8 ; p = 0.003 ) .


After stopping LMWH treatment , only the absence of varicose veins ( OR : 2.5 ; 95 % CI 1.3-5 .0 ; p = 0.004 ) and previous VTE and/or SVT and/or family history of VTE ( OR : 1.9 ; 95 % CI :1.0 -3.7 ; p = 0.048 ) were significantly associated with outcomes .


SVT patients with these factors may deserve a higher intensity and/or longer anticoagulant treatment .


Fingertip amputation is a common injury .


Considerable controversy exists as to whether prophylactic antibiotics are necessary for this injury .


Our goal was to compare the rate of infections among subgroups with and without prophylactic antibiotic treatment .


The study hypothesis was that infection rates were similar in the 2 groups .


This was a prospective randomized control trial of adult patients presenting with fingertip amputation with bone exposed , requiring surgical treatment .


Patients were randomized to 2 groups : group 1 received no antibiotics , and group 2 received 1 g intravenous antibiotics ( cefazolin ) for 3 days .


The 2 groups were matched for age , time to surgery , injury mechanism , and type of surgery .


All surgical treatments were performed in the operating room , and all patients were reevaluated in our outpatient clinic after 10 days and again after a month .


The primary outcome measure was the rate of infection .


Fifty-eight patients were initially enrolled in the study ; 2 patients withdrew before study completion , 29 subjects were randomized to the no-antibiotic group , and 27 subjects were randomized to the antibiotic group .


No statistically significant differences on any baseline values were found between the 2 treatment groups .


There was no infection in either group at the end of follow-up .


This study suggests that routine prophylactic antibiotics do not reduce the rate of infection after fingertip amputations with bone exposed treated surgically in the operating room .


Arthralgia occurs in up to 50 % of breast cancer survivors treated with aromatase inhibitors ( AIs ) and is the most common reason for poor AI adherence .


We conducted , in 121 breast cancer survivors receiving an AI and reporting arthralgia , a yearlong randomized trial of the impact of exercise versus usual care on arthralgia severity .


Eligibility criteria included receiving an AI for at least 6 months , reporting 3 of 10 for worst joint pain on the Brief Pain Inventory ( BPI ) , and reporting < 90 minutes per week of aerobic exercise and no strength training .


Participants were randomly assigned to exercise ( 150 minutes per week of aerobic exercise and supervised strength training twice per week ) or usual care .


The BPI , Western Ontario and McMaster Universities Osteoarthritis ( WOMAC ) index , and Disabilities of the Arm , Shoulder and Hand ( DASH ) questionnaire were completed at baseline and at 3 , 6 , 9 , and 12 months .


Intervention effects were evaluated using mixed-model repeated measures analysis , with change at 12 months as the primary end point .


Over 12 months , women randomly assigned to exercise ( n = 61 ) attended 70 % ( standard deviation [ SD ] , 28 % ) of resistance training sessions and increased their exercise by 159 ( SD , 136 ) minutes per week .


Worst joint pain scores decreased by 1.6 points ( 29 % ) at 12 months among women randomly assigned to exercise versus a 0.2-point increase ( 3 % ) among those receiving usual care ( n = 60 ; P < .001 ) .


Pain severity and interference , as well as DASH and WOMAC pain scores , also decreased significantly at 12 months in women randomly assigned to exercise , compared with increases for those receiving usual care ( all P < .001 ) .


Exercise led to improvement in AI-induced arthralgia in previously inactive breast cancer survivors .


Hyperkalemia is an infrequent but potentially serious complication of low molecular weight heparin ( LMWH ) use .


While there are a number of trials comparing LMWH to unfractionated heparin ( UFH ) there is no comparison of the risk with LMWH versus placebo .


Aim of the present post-hoc analysis of the PARAT trial was the description of serum potassium levels with certoparin compared to placebo .


PARAT was a double-blind , placebo-controlled , randomized trial in patients with coronary artery disease receiving either 8,000 I.U. aXa per day or placebo .


Serum potassium was monitored at baseline and at scheduled follow-up visits at 2 and 4-6 weeks and 3 and 4-6 months .


Statistical evaluation included paired , two sided t-test for each of the treatment groups to compare baseline and follow-up values .


A total of 117 patients ( 59 certoparin , 58 placebo ) were included with a mean age of 59 years and 84.6 % male gender .


There was a statistically significant increase in serum potassium at two weeks after discharge compared to baseline ( p < 0.001 ) in either group which remained elevated throughout the three months treatment phase .


Differences between treatment groups were not statistically significant .


After treatment discontinuation at the three months ' visit serum potassium returned to normal values ( p = n.s. vs. baseline ) in both groups .


Overall 12 out of 59 patients receiving certoparin ( 20.3 % ) and 11 out of 58 patients receiving placebo ( 19.0 % ) experienced hyperkalemia based on threshold of > 5.0 mmol/l at any time during the observation .


We conclude that there is no incremental risk of hyperkalemia with certoparin up to 8,000 I.U. aXa per day versus placebo in patients with coronary artery disease .


The increase in serum potassium values in either group calls for clinical surveillance and the consideration of further risk factors predisposing to hyperkalemia .


Our randomized trial found no survival advantage for axillary dissection ( AD ) compared observation only ( no AD ) in older patients with early breast cancer and a clinically negative axilla , indicating that AD is unnecessary .


We compared characteristics and outcomes in out-trial patients with those in trial patients to provide indications as to whether AD can be safely omitted outside the trial setting .


The trial started in 1996 , recruiting 238 patients age 65-80 years with cT1cN0 breast cancer , randomized to conservative surgery with or without AD .


Over the recruitment period , 109 eligible patients who refused to participate in the trial , also received conservative breast surgery with or without AD depending on patient preference/surgeon opinion .


Trial and out-trial patients received conventionally-fractioned whole breast radiation and tamoxifen for five years .


Endpoints were breast cancer mortality , overall survival , and cumulative incidence of axillary disease in patients not receiving AD .


After 15 years of follow-up , breast cancer mortality and overall survival did not differ between the AD and no AD arms , in either the trial or out-trial cohorts .


The 15-year cumulative incidence of axillary relapse was 6 % in the no AD arm of the trial group , and zero in the no AD arm of the out-trial group .


Outside the trial setting , older patients with T1N0 breast cancer can be safely treated by conservative surgery , postoperative radiotherapy and tamoxifen for five years ( if ER-positive ) .


Axillary surgery is appropriate only for the small proportion of patients who develop overt axillary disease during follow-up .


The aim of the Youth Depression Alleviation-Combined Treatment ( YoDA-C ) study is to determine whether antidepressant medication should be started as a first-line treatment for youth depression delivered concurrently with psychotherapy .


Doubts about the use of medication have been raised by meta-analyses in which the efficacy and safety of antidepressants in young people have been questioned , and subsequent treatment guidelines for youth depression have provided only qualified support .


YoDA-C is a double-blind , randomised controlled trial funded by the Australian government 's National Health and Medical Research Council .


Participants between the ages of 15 and 25 years with moderate to severe major depressive disorder will be randomised to receive either ( 1 ) cognitive behavioural therapy ( CBT ) and fluoxetine or ( 2 ) CBT and placebo .


The treatment duration will be 12 weeks , and follow-up will be conducted at 26 weeks .


The primary outcome measure is change in the Montgomery-sberg Depression Rating Scale ( MADRS ) after 12 weeks of treatment .


The MADRS will be administered at baseline and at weeks 4 , 8 , 12 and 26 .


Secondary outcome measures will address additional clinical outcomes , functioning , quality of life and safety .


Australian and New Zealand Clinical Trials Registry ID : ACTRN12612001281886 ( registered on 11 December 2012 ) .


To investigates factors affecting the positive rate of blocking antibody treated by paternal lymphocyte immunotherapy in patients with recurrent spontaneous abortion ( RSA ) .


From January 2008 to August 2012 , 326 RSA cases undergoing treatment in Infertility Center of Qilu Hospital were studied retrospectively .


Those patients were divided into 2 groups randomly : 260 cases in intradermal injection group were administered via bilateral forearm intradermal injections for immunotherapy once 21 days , then the blocking antibody was determined after 2 ( 23 cases ) , 3 ( 73 cases ) , 4 ( 74 cases ) , 5 ( 90 cases ) times respectively , while in subcutaneous injection group , the 66 cases were administered via subcutaneous injection once 21 days , the blocking antibody measured after 3 times ; In both cases , the blocking antibody was all determined 2 weeks later .


The positive rate of blocking antibodies and the rate of successful pregnancy was recorded , and then followed up after the blocking antibody turning positive .


( 1 ) Positive rate of blocking antibodies : the positive rate of blocking antibodies were 17 % ( 4/23 ) , 58 % ( 42/73 ) , 72 % ( 53/74 ) and 84 % ( 76/90 ) in the 2 , 3 , 4 , and 5 times of intradermal injection group , respectively ( P < 0.05 ) .


In subcutaneous injection group , the positive rate of blocking antibodies was 38 % ( 25/66 ) , which was significantly lower than that in group intradermal injection receiving 3 times immunotherapy ( P < 0.05 ) .


( 2 ) The rate of pregnancy : the 176 patients out of 200 patients were pregnant when antibody was positive after immunotherapy , with 71.6 % ( 126/176 ) of patients gained successful pregnancy ( the length of pregnancy more than 5 months ) .


The route and frequency of administration of immunotherapy could influence the positive rate of blocking antibody .


The rate of successful pregnancy will be increased after blocking antibody turning positive .


The current study examined a 5-year cognitive change in untrained African American and White participants from the Advanced Cognitive Training in Independent and Vital Elderly ( ACTIVE ) study .


Five-year trajectories of memory , reasoning , visual processing speed/useful field of view , digit-symbol substitution , and vocabulary were investigated .


Education , health , gender , age , and retest/practice effects were controlled for , and a missing data pattern mixture approach was used to adjust for dropout effects .


After considering age , education , health , and gender , being African American uniquely explained 2 % to 7 % of the variance in cognitive performance .


There were virtually no significant race differences in the rates of change .


Race-related results in the current study are consistent with previous research suggesting that social advantage factors such as education have a stronger influence on the level of performance than the rate of change .


The small remaining effects of being African American on performance levels likely reflect uncontrolled variation in factors like literacy and financial advantage .


To determine the optimal infertility therapy for women at the end of their reproductive potential .


Randomized clinical trial .


Academic medical centers and private infertility center in a state with mandated insurance coverage .


Couples with 6 months of unexplained infertility ; female partner aged 38-42 years .


Randomized to treatment with two cycles of clomiphene citrate ( CC ) and intrauterine insemination ( IUI ) , follicle stimulating hormone ( FSH ) / IUI , or immediate IVF , followed by IVF if not pregnant .


Proportion with a clinically recognized pregnancy , number of treatment cycles , and time to conception after two treatment cycles and at the end of treatment .


We randomized 154 couples to receive CC/IUI ( N = 51 ) , FSH/IUI ( N = 52 ) , or immediate IVF ( N = 51 ) ; 140 ( 90.9 % ) couples initiated treatment .


The cumulative clinical pregnancy rates per couple after the first two cycles of CC/IUI , FSH/IUI , or immediate IVF were 21.6 % , 17.3 % , and 49.0 % , respectively .


After all treatments , 110 ( 71.4 % ) of 154 couples had conceived a clinically recognized pregnancy , and 46.1 % had delivered at least one live-born baby ; 84.2 % of all live-born infants resulting from treatment were achieved via IVF .


There were 36 % fewer treatment cycles in the IVF arm compared with either COH/IUI arm , and the couples conceived a pregnancy leading to a live birth after fewer treatment cycles .


A randomized controlled trial in older women with unexplained infertility to compare treatment initiated with two cycles of controlled ovarian hyperstimulation/IUI versus immediate IVF demonstrated superior pregnancy rates with fewer treatment cycles in the immediate IVF group .


NCT00246506 .


Grades are commonly used in formative workplace-based assessment ( WBA ) in medical education and training , but may draw attention away from feedback about the task .


A dilemma arises because the self-regulatory focus of a trainee must include self-awareness relative to agreed standards , which implies grading .


In this study we aimed to understand the meaning which medical students construct from WBA feedback with and without grades , and what influences this .


Year 3 students were invited to take part in a randomised crossover study in which each student served as his or her own control .


Each student undertook one WBA with and one without grades , and then chose whether or not to be given grades in a third WBA .


These preferences were explored in semi-structured interviews .


A realist approach to analysis was used to gain understanding of student preferences and the impact of feedback with and without grades .


Of 83 students who were given feedback with and without grades , 65 ( 78 % ) then chose to have feedback with grades and 18 ( 22 % ) without grades in their third WBA .


A total of 24 students were interviewed .


Students described how grades locate their performance and calibrate their self-assessment .


For some , low grades focused attention and effort .


Satisfactory and high grades enhanced self-efficacy .


Grades are concrete , powerful and blunt , can be harmful and need to be explained to help students create helpful meaning from them .


Low grades risk reducing self-efficacy in some and may encourage others to focus on proving their ability rather than on improvement .


A metaphor of the semi-permeable membrane is introduced to elucidate how students reduced potential negative effects and enhanced the positive effects of feedback with grades by selective filtering and pumping .


This study illuminates the complexity of the processing of feedback by its recipients , and informs the use of grading in the provision of more effective , tailored feedback .


Sedation with propofol should be administered by personnel trained in advanced airway management .


To overcome this limitation , the use of short acting benzodiazepines by cardiologists spread widely , causing concerns about the safety of this procedure in the absence of anesthesiology assistance .


The aim of the study was to compare feasibility of a cardiologist-only approach with an anesthesiologist-assisted sedation protocol during elective direct-current cardioversion ( DCC ) of persistent atrial fibrillation ( AF ) .


This prospective , open-blinded , randomized study included 204 patients , which were admitted for scheduled cardioversion of persistent AF , and randomized in a 1:1 fashion to either propofol or midazolam treatment arm .


Patients in the propofol group underwent DCC with anesthesiologist assistance , while patients in the midazolam group saw the cardiologist as the only responsible for both sedation and DCC .


Twenty-three adverse events occurred : 13 in the propofol group and 10 in the midazolam group ( p = NS ) .


Most of them were related to bradyarrhythmias and respiratory depressions .


There was no need of intubation or other advanced resuscitation techniques in any of these patients .


No differences were found regarding procedure tolerability and safety endpoints between the two groups .


DCC procedures with anesthesiology support were burdened by higher delay from scheduled time and higher costs .


Sedation with midazolam administered by cardiologist-only appears to be as safe as sedation with propofol and anesthesiologist assistance .


Adverse events were few in both groups and easily handled by the cardiologist alone .


A cardiologist-only approach to sedation provides less procedural delay , thus being easier to schedule and correlated with fewer costs .


To investigate the effect of low molecular heparin on degree of severity and prognosis of severe pneumonia in elderly patients .


A prospective randomized control study was conducted .


During October 2009 to July 2013 , 63 patients over 65 years old and suffering from severe pneumonia were enrolled .


Patients were grouped into control or treatment group randomly .


The control group ( n = 36 ) received routine treatment , while low molecular heparin 4 kU once a day was added in treatment group ( n = 39 ) for 7 days .


Acute physiology and chronic health evaluationII ( APACHEII ) score , coagulation function indexes , blood gas analysis , arterial lactic acid at 1 , 3 , 7 days after treatment , and length of mechanical ventilation , days of stay in ICU , and 7-day mortality were compared between both groups .


The basic data and APACHEII score had no difference between two groups ( all P > 0.05 ) .


Bleeding events occurred on day 1 , 3 , 7 in 1 , 1 , 2 patients in control group , respectively , and 0 , 1 , 3 cases in treatment group .


There was no difference in APACHEII score on day 1 and day 3 between control group and treatment group ( 1 day : 19.33 5.90 vs. 20.31 4.97 , t = 0.775 , P = 0.441 ; 3 days : 18.69 4.88 vs. 17.41 3.83 , t = 1.272 , P = 0.207 ) .


APACHEII score on day 7 in treatment group was significantly lower than that in control group ( 13.92 3.61 vs. 16.20 4.23 , t = 2.480 , P = 0.016 ) .


There was no significant difference in coagulation function indexes during observation period between two groups ( all P > 0.05 ) .


The blood gas analysis showed that only arterial partial pressure of oxygen ( PaO2 ) 7 days after treatment in treatment group was significantly higher than that in control group ( 110.52 28.57 mm Hg vs. 95.47 24.17 mm Hg , t = -2.354 , P = 0.022 ) .


There was no significant difference in 7-day mortality between two groups .


The mechanical ventilation time in treatment group was slightly shorter than that in control group ( 147.45 111.45 hours vs. 192.20 115.57 hours , t = 1.704 , P = 0.093 ) .


The length of stay in ICU in treatment group was significantly shorter than that in control group ( 13.77 5.77 days vs. 17.22 6.21 days , t = 2.497 , P = 0.015 ) .


In elderly patients suffering from severe pneumonia , low molecular heparin may reduce APACHEII score , shorten mechanical ventilation time and length of ICU stay , and the prognosis may be improved .


Nasal douching is commonly performed after endoscopic sinus surgery ( ESS ) .


There is a lack of studies comparing the clinical effect of various douching solutions after ESS .


This study investigated the clinical effects of normal saline , lactated Ringer 's , and hypertonic saline nasal douching solutions after ESS .


Adult patients ( 41.8 12.9 years ) undergoing bilateral ESS for chronic rhinosinusitis at a single tertiary referral center were blindly randomized to one of the three study solutions and reviewed on postoperative weeks 1 , 3 , and 6 .


The 20-item Sino-Nasal Outcome Test ( SNOT-20 ) scores , visual analog scale ( VAS ) symptom scores , digital video capture of the sinus cavities , and mucociliary clearance ( MCC ) times were performed at each visit .


The mucosa appearances were scored by a second investigator , blinded to the douching solution .


Seventy-four patients were recruited .


All groups showed an improvement with treatment in SNOT-20 scores and VAS scores , as well as endoscopic evaluation of mucosa appearance over time .


There was no improvement of MCC during the treatment period .


Irrigation with lactated Ringer 's solution resulted in better symptom scores in SNOT-20 ( p < 0.05 ) and VAS ( p < 0.05 ) , compared with irrigation with normal saline or hypertonic saline solutions .


Patients receiving hypertonic saline solutions had less polypoidal mucosa at week 6 .


Douching with lactated Ringer 's solution after ESS results in better improvement in sinonasal symptoms , compared with normal saline or hypertonic saline solutions .


Previous studies have shown that the injection of dehydrated alcohol has been successful for the treatment of Morton 's neuroma in the foot .


In this study , we determined the cellular effect of injection of alcohol into and around the sciatic nerve of rats and measured the extent of cell necrosis and/or any associated histologic or inflammatory changes .


Twenty-two male ( ~ 375 g ) Wistar rats were randomized into 2 groups each receiving alcohol injections into or around the sciatic nerve after nerve exposure under sterile technique .


Group 1 rats were injected with a 0.5 ml solution of 0.5 % Marcaine in the left sciatic nerve as a control group .


In the right sciatic nerve a 0.5 ml solution of 4 % ethanol with 0.5 % Marcaine was injected .


Group 2 rats received 0.5 ml of 20 % ethanol with 0.5 % Marcaine injected into the left sciatic nerve and 0.5 ml of 30 % ethanol with 0.5 % Marcaine injected into the right sciatic nerve .


In each group , the rats were placed in 3 subgroups : intraneural , perineural , perimuscular injections .


All rats were sacrificed and tissue harvested for histologic evaluation at day 10 post injection .


No evidence of alcohol-associated cell necrosis , apoptosis , or apparent inflammation was observed in histologic specimens of any injected nerves , perineural tissue , or muscles in controls or experimental groups regardless of concentration of ethanol injected on day 10 .


We concluded that alcohol injection ( 30 % ethanol ) into and/or around the sciatic nerve or the adjacent muscle of rats has no histologic evidence of necrosis or inflammation to the nerve or surrounding tissue .


There was no observable histological change in apoptosis , or cell number , in response to the alcohol injection .


The lack of any measureable changes in nerve or adjacent muscle histology with ethanol injection into the rat sciatic nerve ( and surrounding tissues ) raises questions about the efficacy of using ethanol injections in the treatment of Morton 's neuroma in human clinical practice .


Laparoscopic cholecystectomy frequently results in significant immediate postoperative pain .


A new pain monitor , analgesic nociception index ( ANI ) , based on heart rate variability , has recently been approved for intraoperative nociception monitoring .


We designed a single-blind , parallel-group , randomized control trial to test the hypothesis that protocol-driven intraoperative analgesia guided by ANI during laparoscopic cholecystectomy would improve titration of intraoperative analgesics leading to decreased postoperative pain .


One hundred and twenty consecutive adult participants presenting for elective laparoscopic cholecystectomy were recruited .


Participants were randomly allocated by sealed envelope to receive intraoperative morphine either guided by ANI via a protocol ( intervention group ) or guided by the anaesthetist with ANI concealed ( control group ) .


All participants received paracetamol , parecoxib , fentanyl at induction , and local anaesthetic to port sites .


The primary endpoint was the presence of moderate/severe pain ( visual analogue scale 50 mm ) at any of the four time points in the first postoperative hour .


Secondary endpoints included postoperative rescue morphine .


Sixty participants were randomized to each group , and all but one drop-out from the intervention group were analysed .


The usage of ANI guidance did not result in a decrease in the rate of moderate/severe pain ( 50.8 % vs 45.0 % : difference of -5.8 % , 95 % confidence interval , -23.7 % to 12.1 % , P = 0.58 ) , or the use of postoperative rescue analgesia .


This randomized control trial of intraoperative ANI-guided morphine administration in elective laparoscopic cholecystectomy failed to show any advantage over the current standard of care , and demonstrated a high level of postoperative pain , despite the use of multimodal analgesia .


ANZCTR Reference ACTRN12612000953831 ( URL : http://www.anzctr.org.au/trial_view.aspx?ID=362949 ) .


To compare the therapeutic effects between anatomical locked plate combined with coracoclavicular ligament reconstruction and clavicular hook plate for treatment of distal clavicle fracture of Neer type II b.


From August 2010 to August 2013 , 42 patients with Neer II b distal clavicle fractures were randomly divided into two groups as group A and group B.


In group A , there were 22 cases including 14 males and 8 females with an average age of ( 44.211.6 ) years old .


In group B , there were 20 cases including 11 males and 9 females with an average of ( 45.612.4 ) years old .


The patients of group A were treated with anatomical locked plate combined with coracoclavicular ligament reconstruction , the patients of group B were treated with hook plate .


All fractures were fresh , the time between injuries and operation was 24 hours to 7 days ( mean ,72 h ) .


General information between the two groups was comparable before operation ( P > 0.05 ) .


Postoperative radiographic were followed up to observe the fracture healing , internal fixation and to measure coracoclavicular distance of two groups .


Shoulder function after operation was evaluated by Constant-Murley score system .


All patients were followed up with an average of 16.8 months ( ranging 12 to 24 months ) .


There was no nonunion , infection and other complications between two groups .


The clavicular stress fracture occurred in 1 clavicular hook patient at 6 months after the operation .


According to the Constant-Murley score system , that the scores of group A were 90.66.2 , 91.84.8 , 94.73.6 and 97.81.2 at 1st , 3rd , 6 month and last follow-up after operation were higher than those of group B 74.83.4 , 78.44.4 , 82.22.8 and 94.63.6 ( P 0.05 ) .


The fracture healing time of group A ( 21.62.2 ) weeks was shorter than that of group B ( 25.82.5 ) weeks ( P 0.05 ) .


There were no statistically significant differences between two groups in coracoclavicular distance at last follow-up ( P > 0.05 ) .


The anatomical locked plate combined with coracoclavicular ligament reconstruction need not expose shoulder and can reduce the incidence of postoperative pain and limited activity of shoulder , with fewer complication , it is advantageous to the shoulder joint function early recovery .


Virtual patient simulation has grown substantially in health care education .


A virtual patient simulation was developed as a refresher training course to reinforce nursing clinical performance in assessing and managing deteriorating patients .


The objective of this study was to describe the development of the virtual patient simulation and evaluate its efficacy , by comparing with a conventional mannequin-based simulation , for improving the nursing students ' performances in assessing and managing patients with clinical deterioration .


A randomized controlled study was conducted with 57 third-year nursing students who were recruited through email .


After a baseline evaluation of all participants ' clinical performance in a simulated environment , the experimental group received a 2-hour fully automated virtual patient simulation while the control group received 2-hour facilitator-led mannequin-based simulation training .


All participants were then re-tested one day ( first posttest ) and 2.5 months ( second posttest ) after the intervention .


The participants from the experimental group completed a survey to evaluate their learning experiences with the newly developed virtual patient simulation .


Compared to their baseline scores , both experimental and control groups demonstrated significant improvements ( P < .001 ) in first and second post-test scores .


While the experimental group had significantly lower ( P < .05 ) second post-test scores compared with the first post-test scores , no significant difference ( P = .94 ) was found between these two scores for the control group .


The scores between groups did not differ significantly over time ( P = .17 ) .


The virtual patient simulation was rated positively .


A virtual patient simulation for a refreshing training course on assessing and managing clinical deterioration was developed .