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 @-FU injections , suture lysis , or needling .


PC patients required no additional procedures .


Type @ diabetes ( T@D ) 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 T@D 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 T@D .


@ patients between the ages of @ and @ years with T@D , on two or more oral hypoglycaemic agents and with an HbA@c @ % in the last six months will be recruited from @ general practices .


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


We hypothesize that the intervention arm will achieve an absolute HbA@c mean difference of @ % lower than control group at @ months follow up .


Secondary outcomes include the number of participants who successfully transfer to insulin and the proportion who achieve HbA@c measurement of < @ % .


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 T@D , healthcare professionals and funders of healthcare though making better use of scarce healthcare resources , improving timely access to therapy that can improve disease outcomes .


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 @ months to @ years , testing positive for either rotavirus or Cryptosporidium species in stool ( coinfections were excluded ) , were randomized to LGG ( ATCC @ ) or placebo , once daily for @ 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 @ children enrolled , @ and @ had rotavirus and cryptosporidial diarrhea , respectively .


Median diarrheal duration was @ 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 ( @ % vs @ % ; P = @ ) and impaired intestinal function ( @ % vs @ % ; P = @ ) .


Significant increase in IgG levels postintervention ( @ vs @ EU ; P = @ ) 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 .


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 @ or @ mg or oxycodone IR @ or @ mg every @-@ hours as needed for pain up to @ days after arthroscopic shoulder surgery .


Twice daily , subjects recorded pain intensity from @ ( no pain ) to @ ( pain as bad as you can imagine ) and pain relief from @ ( none ) to @ ( 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 @ days .


Of @ subjects ( @ tapentadol IR , @ oxycodone IR ) who took study medication , @ ( @ tapentadol IR , @ oxycodone IR ) had pain intensity @ before the first dose and were evaluated for efficacy .


Mean SPID scores over @ days were @ and @ in the tapentadol IR and oxycodone IR groups , respectively ( least-squares mean difference -LSB- @ % confidence interval -RSB- , @ -LSB- -@ , @ -RSB- ; p = @ ) .


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 @-@ 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 @ and @ months post-dietary intervention .


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


At @ and @ 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 , @ 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 ( @ years and > @ years ) in the @ 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 > @ years is a strong independent poor prognostic factor ( @-y OS @ % and @ % in @ years and > @ years patients , respectively , P < @ ; @-y CSS @ % and @ % in @ years and > @ years patients , respectively , P = @ ) .


Among women @ years , node negative patients had @ % @-y OS and @ % @-y CSS vs @ % @-y OS and @ % @-y CSS for node positive patients ( P = @ and P = @ , respectively ) , while among women > @ y , node negative patients had @ % @-y OS and @ % @-y CSS vs @ % @-y OS and @ % @-y CSS for node positive patients ( P = @ and P = @ , 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 > @ ) significantly associated with scarce prognosis .


Treatment decisions for older patients with type @ 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 @ mg as add-on therapy to common antihyperglycemic drugs in patients aged @ years and < @ years .


Pooled adverse event data from three placebo-controlled trials of @-@ weeks ' duration in older ( @ years ) and younger ( < @ years ) patients receiving saxagliptin @ 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 @ % confidence intervals were calculated ( Mantel-Haenszel test ) .


A total of @ older ( mean age @ years ; saxagliptin , n = @ ; placebo , n = @ ) and @,@ younger ( mean age @ years ; saxagliptin , n = @ ; placebo , n = @ ) 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 @ .


Treatment-related adverse events occurred in @ older patients receiving saxagliptin versus @ receiving placebo ( incidence rate @ versus @ per @ person-years ) and in @ younger patients in both treatment groups ( incidence rate @ versus @ per @ person-years ) .


With saxagliptin versus placebo , serious adverse events occurred in eight versus @ older ( incidence rate @ versus @ per @ person-years ) and @ versus @ younger patients ( incidence rate @ versus @ per @ person-years ) .


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


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


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


Genetic knockout or pharmacological inhibition of the beta-@ adrenergic receptor ( B@AR ) 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-@ adrenergic agonist and non-selective antagonist on human bone metabolism .


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


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


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


Data were analyzed with mixed model analysis .


@ - estradiol decreased bone turnover compared to control ( P@NP p < @ , CTx p = @ ) , but terbutaline combined with @ - estradiol failed to increase bone turnover compared to @ - estradiol alone ( P@NP p = @ , CTx p = @ ) .


Propranolol did not affect bone turnover compared to control ( P@NP p = @ , CTx p = @ ) .


Selective beta-@ 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 ( @C ) .


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


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


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


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


In thermoneutral conditions , EE values ( mean ( @ % confidence interval ) ) measured by IC and PCM were @ ( @-@ @ ) and @ ( @-@ @ ) kcal , respectively .


In cool conditions , EE values measured by IC and PCM were @ ( @-@ @ ) and @ ( @-@ @ ) kcal , respectively .


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


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


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 .


@ ASA physical status @ and @ children ( aged @-@ yrs ) scheduled for elective surgery with general anesthesia .


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


The systolic blood pressure difference between the arm-forearm or the arm-ankle was within the @ % range in @ % and @ % of measurements , and within the @ % range in @ % and @ % of measurements , respectively .


The diastolic blood pressure difference between the arm-forearm or the arm-ankle was within the @ % range in @ % and @ % and within the @ % range in @ % and @ % of measurements , respectively .


In patients in whom the initial three NIBP measurements were within the @ % range between the forearm and arm , @ % 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 = @ ) who underwent tonsillectomy for recurrent pharyngitis .


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


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


Of the @ patients ( @ % of all eligible ) responding to the GBI questionnaire , @ ( @ % ) were female ; median age was @ years ( range @-@ ) .


GBI Total Scores varied markedly ( range -@ to +@ ) , but on average showed improvement ( median +@ , interquartile range @-@ ) , most evidently in the GBI Physical Health Score ( median +@ ) , 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 = @ ) 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 @ to @ ) .


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 @ children ) were as follows : ( @ ) glutamine alone , n = @ ; ( @ ) glutamine plus vitamin A plus zinc , n = @ ; and a placebo ( zinc plus vitamin A vehicle ) plus glycine ( isonitrogenous to glutamine ) control treatment , n = @ .


Leptin , adiponectin , insulin-like growth factor ( IGF-@ ) , 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 : NCT@ .


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 = @ ) and arginine ( p = @ ) levels at baseline .


After glutamine treatment , leptin was correlated with weight-for-age ( WAZ ) and weight-for-height z-scores ( WHZ ) ( p@ @ ) at a @-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 @ % 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 @weeks .


Patients were evaluated monthly for efficacy and safety .


In all , @ patients completed the study .


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


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


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


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


Using patient assessment ratings , @ % 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 @ % 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 @ years .


Between June @ and August @ , @ , men were recruited , completed baseline telephone interviews , and were than randomized to receive either a video-based intervention ( n = @ ) or brochures only ( n = @ ; overall response rate ,@ % ) and were again interviewed @ months later ( n = @ ; @ % 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 , @ of @ men ( @ % ) self-reported a CSE since receiving intervention materials , and @ of @ ( @ % ) consented for their physician to provide medical information ( received for @ of @ -LSB- @ % -RSB- ) .


Attendance of any CSE was similar between groups ( intervention group , @ of @ -LSB- @ % -RSB- ; control group , @ of @ -LSB- @ % -RSB- ) , but men in the intervention group were more likely to self-report a whole-body CSE ( @ of @ -LSB- @ % -RSB- vs @ of @ -LSB- @ % -RSB- for control group ; P = @ ) .


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


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 .


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 ( @ ) is there an immediate effect on gait in patients using a laterally wedged insole or valgus knee brace ; ( @ ) is there a late ( @ weeks ) effect ; and ( @ ) 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 @ patients were enrolled in that trial , and @ ( @ % ) completed it after @ months .


Of the enrolled patients , @ ( @ % ) 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 @ 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 @ % ( @ ) ( @ % confidence interval -LSB- CI -RSB- , -@ to -@ , p = @ ) of the peak knee adduction moment and @ % ( @ ) ( @ % CI , -@ to -@ , p = @ ) 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 @ % ( @ ) ( @ % CI , -@ to -@ , p = @ ) of the peak knee adduction moment and no reduction of the moment arm were measured after @ weeks .


No reduction of knee adduction moment , moment arm , or ground reaction force was seen in the brace group at baseline and after @ 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 @ 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 < @ cm ( @ ) ) were randomized to treatment with trandolapril @ mg daily/placebo ( @:@ ) .


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


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


Compared with placebo , systolic blood pressure and systemic arterial compliance significantly changed at day @ ( -@ @ vs -@ @ mm Hg , P = @ , and @ @ vs -@ @ mL/m ( @ ) per mm Hg , P = @ , respectively ) .


Changes in left ventricular end systolic volume ( LVESV ) was nonsignificant ( -@ @ vs -@ @ mL , P = @ ) .


At a median of @ days of follow-up , changes in LVESV and N-terminal pro-brain natriuretic peptide were even lower revealing significant differences between the groups ( -@ @ vs -@ @ mL , P = @ , and -@ @ vs @ @ pmol/L , P = @ , 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 @h .


Babies were @weeks , @h 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 ( < @ mM ) for > @h .


Samples were taken from @ hypoglycaemic babies at @ ; @-@ @ ( median ; range ) hours after birth .


Concentrations of glucose and - hydroxybutyrate were low ( @ ; @-@ @ mM and @ ; @-@ @ mM ) , but lactate concentrations varied widely ( @ ; @-@ @ 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 @h 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 .


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 @ patients with COPD ( mean SD age , @ @ years ; FEV@ , @ @ % predicted ) before and after @ months of pulmonary rehabilitation .


The choice of the outcome ( daily number of steps -LSB- STEPS -RSB- , time spent in at least moderate physical activity -LSB- TMA -RSB- , mean metabolic equivalents of task level -LSB- METS -RSB- , and activity time -LSB- ACT -RSB- ) , 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 @ were investigated .


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


Excluding weekends decreased the sample size for STEPS ( @ vs @ ) , TMA ( @ vs @ ) , and METS ( @ vs @ ) .


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


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


Differences in DT were an important confounder .


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


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 @ subjects ( @-@ years of age ) with complaints of insidious onset of mechanical pain that has lasted for less than @ 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 < @ ) and no significance between groups ( p > @ ) 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 @ times per week in the last year , did not smoke cigarettes , and were interested in quitting were randomized to receive either brief ( @ in-person session and @ phone calls ) or intensive ( @ in-person sessions and @ 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 < @ ppm .


Secondary end points were @ 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 @-month assessment were @ % and @ % , respectively .


Previous success in quitting ( OR = @ ; @ % CI = @-@ @ ) predicted cessation .


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


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


Participants were followed every @ months for @ 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 @ % less likely to use drugs and @ % 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-@ fatty acids in sepsis are conflicting .


In this study , the effect of administration of parenteral n-@ 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 @ ml/kg/day of a lipid emulsion containing highly refined fish oil ( equivalent to n-@ fatty acids @ mg/kg/day ) during @ days after admission to the intensive care unit or standard treatment .


Markers of brain injury and inflammatory mediators were measured on days @ , @ , @ and @ .


Assessment for sepsis-associated delirium was performed daily .


The primary outcome was the difference in S-@ 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-@ from baseline to peak level was @ ( @ % CI : -@ -@ ) between the intervention and control group , respectively ( P = @ ) .


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


Incidence of sepsis-associated delirium was @ % in the intervention and @ % in the control groups ( risk difference @ % , @ % CI -@ -@ % , P = @ ) .


Administration of n-@ 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 @ patients who were randomized into @ groups and administered contrast medium of either @ , @ , or @ mg of iodine per kilogram ( mgI/kg ) .


All patients underwent dual-energy CT at either @ or @ kilovolt ( peak ) ( kV -LSB- p -RSB- ) .


Control images ( @ kV -LSB- p -RSB- ) were acquired from them and were compared with @-kV ( p ) images .


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


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


No significant difference was observed for the CT values of the @-kV ( p ) images with the @-mgI/kg dose and the control images ( @ mgI/kg at @ kV -LSB- p -RSB- ) .


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


The dipeptidyl-peptidase-IV ( DPP-@ ) inhibitors , including sitagliptin , are used for the treatment of type @ diabetes mellitus ( T@DM ) .


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 T@DM has not fully elucidated in Japanese T@DM patients .


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


Twenty-six consecutive Japanese T@DM outpatients were recruited between April @ and March @ , and randomized into the control ( conventional treatment , n = @ ) group and sitagliptin treatment group ( n = @ ) .


Serum adiponectin was measured by enzyme-linked immunosorbent assay .


Indices of glycemic control , such as hemoglobin A@c , glycated albumin , and @-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 @ to @ g/mL without change of body mass index ( p = @ ) , while serum adiponectin level was not altered in the control group ( p = @ ) .


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


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 @ to March @ .


ED patients who self-reported drug use within the past @ 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 @ participants in the study , the median age was @ years ( interquartile range -LSB- IQR -RSB- = @ to @ years ) , @ % were female , @ % had ever been tested for HIV , and @ % had ever been tested for HCV .


Uptake of combined rapid HIV/HCV screening was nearly identical by study arm ( @ % vs. @ % ; = -@ % ; @ % confidence interval -LSB- CI -RSB- = -@ % to @ % ) .


Of the @ screened , none had reactive HIV antibody tests , but seven ( @ % ) 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 @ % 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 @ % sodium hyaluronate ( treatment ) in one eye and one drop of sterile @ % 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 , @ , @ , @ , @ , and @ 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 = @ , @ , and @ , respectively ) .


Although a statistically significant ( p = @ ) decrease from baseline in spherical aberrations was noted in the treatment group at @ 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 < @ ) .


A single instillation of hypotonic @ % 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 , @ weeks , @ months , and @ months .


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


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


We examined @ SCUT participants at @ years after enrollment .


Among those in this cohort , mean logMAR BSCVA at enrollment was @ ( Snellen equivalent , @/@ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) .


On average , visual acuity improved by @ logMAR lines from enrollment to @ weeks ( P < @ ) , @ lines from @ weeks to @ months ( P = @ ) , and @ lines from @ to @ months ( P = @ ) .


The BSCVA did not change significantly between @ months and @ years ( @-line improvement , P = @ ) .


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


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


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


( ClinicalTrials.gov number , NCT@ . )


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 @ml ropivacaine @ mg/ml ( n = @ ) ( R group ) or saline ( n = @ ) ( C group ) and after @min a second ACB with the opposite study medication , according to randomization .


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


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


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


At rest , mean pain score difference was @ ( @ to @ ) mm , P < @ , and during walk : @ ( @ to @ ) mm , P = @ 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 @ cases as a baseline set .


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


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


Grading accuracy , understaging , overstaging , mean reading times and confidence scores ( scale @-@ ) were compared between baseline and set @ , 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 @ % ( @ % CI , @-@ % ) at baseline to @ % ( @ % CI , @-@ % ) in set @ ( P = @ ) .


Understaging decreased from @ % ( @ % CI , @-@ % ) to @ % ( @ % CI , @-@ % ) ( P < @ ) .


Overstaging did not change significantly ( @ % vs @ % ) .


Mean reading time decreased from @ min @ s to @ min @ s ( P < @ ) .


Mean confidence increased from @ to @ ( P < @ ) .


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


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


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 @ 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 ( @-@years ) participated in the double-blind crossover randomized study .


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


Before and minutes of @ , @ , @ and @ after administration , lead II electrocardiogram ( ECG ) was recorded for @min .


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 < @ ) , SDNN ( P < @ ) , PNN@ % ( P < @ ) , RMSSD ( P < @ ) , HFnu ( P < @ ) and LF/HF ratio ( P < @ ) values were significantly increased relative to baseline at various time points in all the groups except in placebo group .


LFnu ( P < @ ) 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 @ , @ and @mg 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 MF@ ( ATIV ) in previously nonvaccinated children less than @ years of age .


The MF@-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 MF@ induced a larger expansion of vaccine-specific CD@ T cells .


Interestingly , the adjuvant MF@ did not modify the cytokine profile of the elicited T cells , characterized by the production of IL-@ and TNF - , and did not bias the response toward either Th@ or Th@ .


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 MF@ 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-@ .


A total of @ 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 : ( @ ) a modern medicine control group ( MMC group , @ patients ) ; ( @ ) a `` tonifying qi and detoxification '' ( `` TQD '' ) group ( @ patients ) ; and ( @ ) a `` tonifying the kidney to promote liver regeneration and repair by affecting stem cells and their microenvironment '' ( `` TTK '' ) group ( @ 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 @ wk and then followed at @ 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 @-wk post-treatment time point , the patient fatality rates in the MMC , `` TQD '' , and `` TTK '' groups were @ % , @ % , and @ % , respectively , and the differences between groups were statistically significant ( P < @ ) .


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


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


Serum albumin levels were significantly increased in both the `` TQD '' group and `` TTK '' group as compared with the MMC group ( @ g/L @ g/L , @ g/L @ g/L vs @ g/L @ g/L , P < @ ) .


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


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 @ and older ) with self-reported activity limitations in community practice .


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


mean number of moderate to very severe symptoms from a list of @ 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 @ groups ( Study group Time P = @ ) , and there were significantly more changes in medication regimens in the LWD + CMM group ( P = @ 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 , @-week three centre trial of memantine ( @mg/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 @ and @weeks .


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 @ patients ( @ DLB and @ 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 @ and March @ .


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


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


The total length of ovarian stimulation could not exceed @ 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 = @ ; LD group , n = @ ) .


Mono-follicular development rates ( primary endpoint ) were similar in both groups ( CLD : @ % -LSB- @/@ -RSB- versus LD : @ % -LSB- @/@ -RSB- , p = @ ; 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 @ days in the CLD group and @ days in the LD group .


Clinical pregnancy rates for those patients who received an hCG injection were similar in both groups ( CLD : @ % -LSB- @/@ -RSB- versus LD : @ % -LSB- @/@ -RSB- , p = @ ; 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 @ to April @ , we included in a randomized noninferiority trial all HIV type @-infected pregnant women ( @ weeks ' gestation , CD@ count @ cells/L , hemoglobin level @ g/L ) in @ health centers in Togo .


Women were randomly assigned to daily @ mg/@ 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 @ women randomly assigned to the CMX or IPT-SP group , @ of @ and @ of @ , respectively , were included in the analysis .


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


Ninety-five of @ ( @ % ) women in the CMX group and @ of @ ( @ % ) in the IPT-SP group remained malaria-free during their pregnancy ( difference , @ % ; @ % confidence interval -LSB- CI -RSB- , -@ to @ , not meeting the predefined noninferiority criterion ) .


The incidence rate in intention-to-treat analysis was @ malaria episodes per @ person-years in CMX ( @ % CI , @-@ @ ) and @ in IPT-SP ( @ % CI , @-@ @ ) ( not significant ) .


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


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


Grade @-@ anemia was more frequent in the CMX group ( @ % vs @ % ; P = @ ) .


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 ISRCTN@ .


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 @ children aged @ months to @ 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-@ ) at entry and after @ months and @ 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 @ cm in length of the internal or external saphenous veins or their collaterals were randomized in a double blind fashion to receive either parnaparin @ UI aXa od for ten days followed by placebo for @ days or @ UI aXa od for ten days followed by @ UI aXa od for @ days or @ UI aXa od for @ days .


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


@ outcomes ( @ % ) were recorded during @ days among @ patients ( M/F : @/@ , mean age @ ) .


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


After stopping LMWH treatment , only the absence of varicose veins ( OR : @ ; @ % CI @-@ @ ; p = @ ) and previous VTE and/or SVT and/or family history of VTE ( OR : @ ; @ % CI :@ -@ ; p = @ ) 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 @ 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 @ groups : group @ received no antibiotics , and group @ received @ g intravenous antibiotics ( cefazolin ) for @ days .


The @ 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 @ days and again after a month .


The primary outcome measure was the rate of infection .


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


No statistically significant differences on any baseline values were found between the @ 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 @ % of breast cancer survivors treated with aromatase inhibitors ( AIs ) and is the most common reason for poor AI adherence .


We conducted , in @ 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 @ months , reporting @ of @ for worst joint pain on the Brief Pain Inventory ( BPI ) , and reporting < @ minutes per week of aerobic exercise and no strength training .


Participants were randomly assigned to exercise ( @ 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 @ , @ , @ , and @ months .


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


Over @ months , women randomly assigned to exercise ( n = @ ) attended @ % ( standard deviation -LSB- SD -RSB- , @ % ) of resistance training sessions and increased their exercise by @ ( SD , @ ) minutes per week .


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


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


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 @,@ I.U. aXa per day or placebo .


Serum potassium was monitored at baseline and at scheduled follow-up visits at @ and @-@ weeks and @ and @-@ 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 @ patients ( @ certoparin , @ placebo ) were included with a mean age of @ years and @ % male gender .


There was a statistically significant increase in serum potassium at two weeks after discharge compared to baseline ( p < @ ) 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 @ out of @ patients receiving certoparin ( @ % ) and @ out of @ patients receiving placebo ( @ % ) experienced hyperkalemia based on threshold of > @ mmol/l at any time during the observation .


We conclude that there is no incremental risk of hyperkalemia with certoparin up to @,@ 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 @ , recruiting @ patients age @-@ years with cT@cN@ breast cancer , randomized to conservative surgery with or without AD .


Over the recruitment period , @ 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 @ 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 @-year cumulative incidence of axillary relapse was @ % 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 T@N@ 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 @ and @ years with moderate to severe major depressive disorder will be randomised to receive either ( @ ) cognitive behavioural therapy ( CBT ) and fluoxetine or ( @ ) CBT and placebo .


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


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


The MADRS will be administered at baseline and at weeks @ , @ , @ and @ .


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


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


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


Those patients were divided into @ groups randomly : @ cases in intradermal injection group were administered via bilateral forearm intradermal injections for immunotherapy once @ days , then the blocking antibody was determined after @ ( @ cases ) , @ ( @ cases ) , @ ( @ cases ) , @ ( @ cases ) times respectively , while in subcutaneous injection group , the @ cases were administered via subcutaneous injection once @ days , the blocking antibody measured after @ times ; In both cases , the blocking antibody was all determined @ 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 .


( @ ) Positive rate of blocking antibodies : the positive rate of blocking antibodies were @ % ( @/@ ) , @ % ( @/@ ) , @ % ( @/@ ) and @ % ( @/@ ) in the @ , @ , @ , and @ times of intradermal injection group , respectively ( P < @ ) .


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


( @ ) The rate of pregnancy : the @ patients out of @ patients were pregnant when antibody was positive after immunotherapy , with @ % ( @/@ ) of patients gained successful pregnancy ( the length of pregnancy more than @ 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 @-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 @ % to @ % 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 @ months of unexplained infertility ; female partner aged @-@ 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 @ couples to receive CC/IUI ( N = @ ) , FSH/IUI ( N = @ ) , or immediate IVF ( N = @ ) ; @ ( @ % ) couples initiated treatment .


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


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


There were @ % 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 .


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 @ 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 @ students who were given feedback with and without grades , @ ( @ % ) then chose to have feedback with grades and @ ( @ % ) without grades in their third WBA .


A total of @ 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 @ patients , which were admitted for scheduled cardioversion of persistent AF , and randomized in a @:@ 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 : @ in the propofol group and @ 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 @ to July @ , @ patients over @ years old and suffering from severe pneumonia were enrolled .


Patients were grouped into control or treatment group randomly .


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


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


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


Bleeding events occurred on day @ , @ , @ in @ , @ , @ patients in control group , respectively , and @ , @ , @ cases in treatment group .


There was no difference in APACHEII score on day @ and day @ between control group and treatment group ( @ day : @ @ vs. @ @ , t = @ , P = @ ; @ days : @ @ vs. @ @ , t = @ , P = @ ) .


APACHEII score on day @ in treatment group was significantly lower than that in control group ( @ @ vs. @ @ , t = @ , P = @ ) .


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


The blood gas analysis showed that only arterial partial pressure of oxygen ( PaO@ ) @ days after treatment in treatment group was significantly higher than that in control group ( @ @ mm Hg vs. @ @ mm Hg , t = -@ , P = @ ) .


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


The mechanical ventilation time in treatment group was slightly shorter than that in control group ( @ @ hours vs. @ @ hours , t = @ , P = @ ) .


The length of stay in ICU in treatment group was significantly shorter than that in control group ( @ @ days vs. @ @ days , t = @ , P = @ ) .


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 ( @ @ 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 @ , @ , and @ .


The @-item Sino-Nasal Outcome Test ( SNOT-@ ) 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-@ 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-@ ( p < @ ) and VAS ( p < @ ) , compared with irrigation with normal saline or hypertonic saline solutions .


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


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 ( ~ @ g ) Wistar rats were randomized into @ groups each receiving alcohol injections into or around the sciatic nerve after nerve exposure under sterile technique .


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


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


Group @ rats received @ ml of @ % ethanol with @ % Marcaine injected into the left sciatic nerve and @ ml of @ % ethanol with @ % Marcaine injected into the right sciatic nerve .


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


All rats were sacrificed and tissue harvested for histologic evaluation at day @ 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 @ .


We concluded that alcohol injection ( @ % 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 @ 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 ( @ % vs @ % : difference of -@ % , @ % confidence interval , -@ % to @ % , P = @ ) , 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 .


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 @ to August @ , @ 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 @ cases including @ males and @ females with an average age of ( @ ) years old .


In group B , there were @ cases including @ males and @ females with an average of ( @ ) 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 @ hours to @ days ( mean ,@ h ) .


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


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 @ months ( ranging @ to @ months ) .


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


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


According to the Constant-Murley score system , that the scores of group A were @ , @ , @ and @ at @st , @rd , @ month and last follow-up after operation were higher than those of group B @ , @ , @ and @ ( P @ ) .


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


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


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 @ 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 @-hour fully automated virtual patient simulation while the control group received @-hour facilitator-led mannequin-based simulation training .


All participants were then re-tested one day ( first posttest ) and @ 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 < @ ) in first and second post-test scores .


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


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


The virtual patient simulation was rated positively .


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


Although the randomized controlled study did not show that the virtual patient simulation was superior to mannequin-based simulation , both simulations have demonstrated to be effective refresher learning strategies for improving nursing students ' clinical performance .


Given the greater resource requirements of mannequin-based simulation , the virtual patient simulation provides a more promising alternative learning strategy to mitigate the decay of clinical performance over time .


Caloric restriction ( CR ) , energy intake reduced below ad libitum ( AL ) intake , increases life span in many species .


The implications for humans can be clarified by randomized controlled trials of CR .


To determine CR 's feasibility , safety , and effects on predictors of longevity , disease risk factors , and quality of life in nonobese humans aged @-@ years , @ persons were randomized to a @-year intervention designed to achieve @ % CR or to AL diet .


Outcomes were change from baseline resting metabolic rate adjusted for weight change ( `` RMR residual '' ) and core temperature ( primary ) ; plasma triiodothyronine ( T@ ) and tumor necrosis factor - ( secondary ) ; and exploratory physiological and psychological measures .


Body mass index averaged @ ( range : @-@ @ kg/m ( @ ) ) .


Eighty-two percent of CR and @ % of AL participants completed the protocol .


The CR group achieved @ % CR ( mean standard error ) and maintained @ % weight loss .


Weight change in AL was negligible .


RMR residual decreased significantly more in CR than AL at @ months ( p = @ ) but not @ months ( M@ ) .


Core temperature change differed little between groups .


T@ decreased more in CR at M@ and M@ ( p < @ ) , while tumor necrosis factor - decreased significantly more only at M@ ( p = @ ) .


CR had larger decreases in cardiometabolic risk factors and in daily energy expenditure adjusted for weight change , without adverse effects on quality of life .


Sustained CR is feasible in nonobese humans .


The effects of the achieved CR on correlates of human survival and disease risk factors suggest potential benefits for aging-related outcomes that could be elucidated by further human studies .


Although scientific knowledge about the benefits of probiotic use in cystis fibrosis ( CF ) is scarce , their expectative is promising .


The aim of this work was to analyze the effect of a Lactobacillus reuteri probiotic preparation versus placebo in CF patients .


A prospective , double blind , crossover and with placebo study was carried out in @ CF patients from two Spanish hospitals .


Patients were randomized in Group A ( @ months of probiotic followed by @ months of placebo ) and Group B ( @ months of placebo followed by @ months of probiotic ) .


GIQLI ( gastrointestinal ) and SF-@ ( general ) health tests were performed after probiotic and placebo intakes .


Fat absorption coefficient , calprotectin , and inflammatory interleukin quantification were determined in fecal samples .


Total fecal DNA was obtained and metagenomic @-pyrosequencing was applied to analyze the microbiome composition .


STATA v@ MP software was used for statistical analyses .


Statistically significant improvement in the gastrointestinal health and decrease of the calprotectin levels were demonstrated in patients after probiotic exposure , in comparison with placebo .


All CF subjects reported good tolerance to L. reuteri without secondary effects .


Metagenomic analysis showed an important dysbiosis in CF gut microbiota associated with a high concentration of Proteobacteria .


Probiotic intake was followed by a reduction in the total bacterial density , mostly due to a considerable reduction in the - Proteobacteria phylum ; and an important increase of the microbial diversity with a higher representation of Firmicutes .


Probiotics might ameliorate the dysbiosis of CF gut microbiota , characterized by a high density of Proteobacterial organisms .


L. reuteri significantly decrease intestinal inflammation and increase digestive comfort .


The magnitude of effect of sublingual immunotherapy for house dust mite ( HDM ) - induced allergic rhinitis with or without conjunctivitis is uncertain , partly because there are few well-controlled trials with well-defined doses .


We sought to determine the dose-related efficacy and onset of action of the HDM sublingual immunotherapy tablet MK-@ ( Merck/ALK-Abell ) using the Vienna Challenge Chamber .


In this randomized , double-blind , single-site trial , adults with HDM-induced allergic rhinitis with or without conjunctivitis and with or without asthma ( n = @ ) received @ developmental units ( DU ) of MK-@ , @ DU of MK-@ , or placebo daily for @ weeks .


Subjects underwent @-hour exposure challenges at screening and weeks @ , @ , and @ .


The total nasal symptom score ( TNSS ) during chamber challenge at week @ was the primary end point .


The TNSS was the sum of @ nasal symptom scores ( maximum = @ ) .


Total ocular symptom scores ( TOSSs ; @ symptoms ; maximum = @ ) and total symptom scores ( TSSs ; TSS = TNSS plus TOSS ; maximum = @ ) were secondary end points .


Dose - and time-dependent improvements with MK-@ versus placebo were observed .