The REbif FLEXible dosing in early MS ( REFLEX ) study compared several brain MRI outcomes in patients presenting with clinically isolated syndromes suggestive of multiple sclerosis and treated with two dose-frequencies of subcutaneous interferon ( IFN ) -@ a or placebo .


Patients were randomised ( @:@:@ ) to IFN -@ a , @ g subcutaneously three times a week or once a week , or placebo three times a week for up to @ months .


MRI scans were performed every @ months , or every @ months if the patient developed clinically definite multiple sclerosis .


End points analysed included : number of combined unique active lesions per patient per scan ; numbers and volumes of new T@ , T@ hypointense and gadolinium-enhancing ( Gd + ) lesions per patient per scan ; and brain volume .


@ patients were randomised ( intent-to-treat population : subcutaneous IFN -@ a three times a week , n = @ ; subcutaneous IFN -@ a once a week , n = @ ; placebo , n = @ ) .


Combined unique active lesions were lower in patients treated with subcutaneous IFN -@ a versus placebo ( mean ( SD ) lesions per patient per scan : three times a week @ ( @ ) ; once a week @ ( @ ) ; placebo @ ( @ ) ; reduction versus placebo : three times a week @ % ; once a week @ % ; p < @ ) and with three times a week versus once a week ( @ % reduction ; p = @ ) .


The mean numbers of new T@ , T@ hypointense and Gd + lesions were all significantly lower in the two active treatment arms compared with placebo ( p@ @ for three times a week or once a week ) and in the three times a week group compared with once a week ( p@ @ ) .


Both subcutaneous IFN -@ a @ g regimens improved MRI outcomes versus placebo , with the three times a week regimen having a more pronounced effect than once a week dosing .


Adjunctive-to-insulin therapy with sodium-glucose cotransporter @ ( SGLT@ ) inhibition may improve glycemic control in type @ diabetes ( T@D ) .


We evaluated the glycemic efficacy and safety of empagliflozin @ mg daily in @ patients treated for @ weeks in a single-arm open-label proof-of-concept trial ( NCT@ ) .


Mean A@C decreased from @ @ % ( @ @ mmol/mol ) to @ @ % ( @ @ mmol/mol ) ( P < @ ) , fasting glucose from @ @ to @ @ mmol/L ( P = @ ) , symptomatic hypoglycemia ( < @ mmol/L ) from @ to @ events per patient per day ( P = @ ) , and daily insulin dose from @ @ to @ @ units/day ( P < @ ) .


Mean urinary excretion of glucose increased from @ @ to @ @ g/day ( P < @ ) .


Weight decreased from @ @ to @ @ kg ( P < @ ) , and waist circumference decreased from @ @ to @ @ cm ( P < @ ) .


This proof-of-concept study strongly supports a randomized clinical trial of adjunctive-to-insulin empagliflozin in patients with T@D .


Heavy drinking is common among students at UK universities .


US students overestimate how much their peers drink and correcting this through the use of social norm messages may promote responsible drinking .


We tested whether there is an association between perceived campus drinking norms and usual drinking behavior in UK university students and whether norm messages about responsible drinking correct normative misperceptions and increase students ' intentions to drink responsibly .


@,@ UK university students took part in an online study .


Participants were exposed to one of five message types : a descriptive norm , an injunctive norm , a descriptive and injunctive norm , or one of two control messages .


Message credibility was assessed .


Afterwards participants completed measures of intentions to drink responsibly and we measured usual drinking habits and perceptions of peer drinking .


Perceptions of peer drinking were associated modestly with usual drinking behavior , whereby participants who believed other students drank responsibly also drank responsibly .


Norm messages changed normative perceptions , but not in the target population of participants who underestimated responsible drinking in their peers at baseline .


Norm messages did not increase intentions to drink responsibly and although based on accurate data , norm messages were not seen as credible .


In this UK based study , although perceived social norms about peer drinking were associated with individual differences in drinking habits , campus wide norm messages about responsible drinking did not affect students ' intentions to drink more responsibly .


More research is required to determine if this approach can be applied to UK settings .


Oxaliplatin is an integral component of colorectal cancer treatment , but its use is limited by neurotoxicity .


The Combined Oxaliplatin Neurotoxicity Prevention Trial ( CONcePT ) tested intermittent oxaliplatin ( IO ) administration and the use of concurrent calcium and magnesium salts ( Ca/Mg ) , two modifications intended to reduce neurotoxicity and extend the duration of treatment .


In this trial involving double randomization , @ patients were randomized to receive modified FOLFOX@ plus bevacizumab with IO ( eight-cycle blocks of oxaliplatin treatment ) versus continuous oxaliplatin ( CO ) ; and Ca/Mg versus placebo ( pre - and postoxaliplatin infusion ) .


The primary end point was time-to-treatment failure ( TTF ) .


One hundred thirty-nine patients were entered and treated up to the point of early study termination due to concerns by the data-monitoring committee ( DMC ) that Ca/Mg adversely affected tumor response .


Tumor response was not a study end point .


Given DMC concerns , an additional independent , blinded radiology review of all images showed no adverse effect of treatment schedule or Ca/Mg on response by Response Evaluation Criteria In Solid Tumors .


The IO schedule was superior to CO -LSB- hazard ratio ( HR ) = @ , P = @ -RSB- for both TTF and time-to-tumor progression ( TTP ) ( HR = @ , P = @ ) .


An IO dosing schedule had a significant benefit on both TTF and TTP versus CO dosing in this trial despite the very attenuated sample .


There was no effect of Ca/Mg on response .


New-generation drug-eluting coronary stents have reduced the risk of coronary events , especially in patients with complex disease or lesions .


To what extent different stent platforms , polymers , and antiproliferative drugs affect outcomes , however , is unclear .


We investigated the safety and efficacy of a third-generation stent by comparing a highly biocompatible durable-polymer-coated zotarolimus-eluting stent with a biodegradable-polymer-coated biolimus-eluting stent .


This open-label , randomised , multicentre , non-inferiority trial was done at three sites across western Denmark .


All patients who presented with stable coronary artery disease or acute coronary syndromes and at least one coronary artery lesion ( more than @ % stenosis ) from March , @ , to August , @ , were assessed for eligibility .


Patients were randomly assigned in a @:@ ratio to receive either the durable-polymer zotarolimus-eluting stent or the biodegradable-polymer biolimus-eluting stent .


The primary endpoint was a composite of safety ( cardiac death and myocardial infarction not clearly attributable to a non-target lesion ) and efficacy ( target-lesion revascularisation ) at @ months , analysed by intention to treat .


The trial was powered to assess non-inferiority of durable-polymer zotarolimus-eluting stent compared with the biodegradable-polymer biolimus-eluting stent with a predetermined non-inferiority margin of @ .


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


Of @ screened , @ patients with @ lesions were assigned to receive the durable-polymer zotarolimus-eluting stent and @ patients with @ lesions to receive the biodegradable-polymer biolimus-eluting stent .


@ ( @ % ) and @ ( @ % ) patients , respectively , met the primary endpoint ( absolute risk difference @ , upper limit of one-sided @ % CI @ % ; p = @ ) .


The individual components of the primary endpoint did not differ significantly between stent types at @ months .


The durable-polymer-coated zotarolimus-eluting stent was non-inferior to the biodegradable-polymer-coated biolimus-eluting stent in unselected patients .


To explore the efficacy and effect mechanism of the combined therapy of acupuncture and tapping method in the treatment of obesity and hyperlipidemia of liver qi stagnation and spleen deficiency pattern in the patients .


One hundred and four female patients were randomized into a combined therapy of acupuncture and tapping ( combined therapy group ) group method and an acupuncture group , @ cases in each group .


In the acupuncture group , acupuncture was applied to Qimen ( LR @ ) , Taichong ( LR @ ) , Zhangmen ( LR @ ) , Taibai ( SP @ ) , Zusanli ( ST @ ) , Geshu ( BL @ ) , Ganshu ( BL @ ) , Pishu ( BL @ ) , etc. .


In the combined therapy group , on the basis of acupuncture treatment , the tapping method with plum blossom needle was used at each acupoint .


The treatment was given once every two days , continuously for @ months in the two groups .


The indices were observed , including the obesity indices , such as body mass , body mass index ( BMI ) , body fat percentage ( F % ) and obesity degree ( A ) ; the blood lipid levels such as total cholesterol ( TC ) , triglyceride ( TG ) , low density lipoprotein ( LDL ) and high density lipoprotein ( HDL ) ; the fat-islet axie relevant indices such as fasting plasma glucose ( FBS ) , fasting leptin ( FLP ) , fasting insulin ( FINS ) , insulin sensitive index ( ISI ) , insulin resistance in - dex ( Homa IR ) , insulin secretion index ( Homa - ) and autonomic nerve function index ( Y value ) before and after treatment in the patients of two groups .


The efficacy was compared between the two groups .


The total effective rates were @ % ( @/@ ) and @ % ( @/@ ) in the combined therapy group and the acupuncture group respectively , without significant difference in comparison ( P > @ ) .


Obesity indices , blood lipid indices , fat-islet axie relevant indices and autonomic nerve function indices were all improved after treatment as compared with those before treatment in the two groups ( P < @ , P < @ ) , and the improvements in the combined therapy group were much more significant ( P < @ , P < @ ) .


The combined therapy of acupuncture and tapping method achieves the double effects of weight loss and lipid loss in the treatment of obesity combined with hyperlipidemia .


The effect mechanism is possibly related to the positive regulations of blood glucose , lipid metabolism and fat-islet axie in the patients .


Cervical radicular pain is a major cause of disability .


No studies have been published comparing different types of nonsurgical therapy .


A comparative-effectiveness study was performed in @ patients with cervical radicular pain less than @ yr in duration .


Participants received nortriptyline and/or gabapentin plus physical therapies , up to three cervical epidural steroid injections ( ESI ) or combination treatment over @ months .


The primary outcome measure was average arm pain on a @ to @ scale at @ month .


One-month arm pain scores were @ ( @ % CI , @ to @ ) in the combination group , @ ( CI , @ to @ ) in ESI patients , and @ ( CI , @ to @ ) in individuals treated conservatively ( P = @ ) .


Combination group patients experienced a mean reduction of -@ ( @ % CI , -@ to -@ ) in average arm pain at @ month versus -@ ( CI , -@ to -@ ) in the conservative group and -@ ( CI , -@ to -@ ) in ESI patients ( P = @ ) .


For neck pain , a mean reduction of -@ ( @ % CI , -@ to -@ ) was noted in combination patients versus -@ ( CI , -@ to -@ ) in conservative group patients and -@ ( CI , -@ to -@ ) in those who received ESI ; P = @ ) .


Three-month posttreatment , @ % of patients treated with combination therapy experienced a positive outcome versus @ % in the conservative group and @ % in ESI patients ( P = @ ) .


For the primary outcome measure , no significant differences were found between treatments , although combination therapy provided better improvement than stand-alone treatment on some measures .


Whereas these results suggest an interdisciplinary approach to neck pain may improve outcomes , confirmatory studies are needed .


This study examines the cost effectiveness of group follow-up after participation in the Dose Adjustment for Normal Eating ( DAFNE ) structured education programme for type @ diabetes .


Economic evaluation conducted alongside a cluster randomised controlled trial involving @ adults with type @ diabetes in Ireland .


Group follow-up involved two group education ` booster ' sessions post-DAFNE .


Individual follow-up involved two standard one-to-one hospital clinic visits .


Incremental costs , quality-adjusted life years ( QALYs ) gained and cost effectiveness were estimated at @ months .


Uncertainty was explored using sensitivity analysis and by estimating cost effectiveness acceptability curves .


Group follow-up was associated with a mean reduction in QALYs gained of @ per patient ( P value , @ ; @ % CI , -@ to @ , intra-class correlation ( ICC ) , @ ) and a mean reduction in total healthcare costs of @ ( P value , @ ; @ % CI , -@,@ to -@ : ICC , @ ) per patient .


At alternative threshold values of @,@ , @,@ , @,@ , @,@ , and @,@ , the probability of group follow-up being cost effective was estimated to be @ , @ , @ , @ , and @ respectively .


The results do not support implementation of group follow-up as the sole means of follow-up post-DAFNE .


Given the reported cost savings , future studies should explore the cost effectiveness of alternative models of group care for diabetes .


To evaluate and compare the effectiveness of the combined regimen ( consisting of condoms and emergency contraception pills ( ECP ) ) and using condoms only for the purpose of preventing pregnancy .


One-thousand-five-hundred-and-sixty-two ( @,@ ) couples as volunteers enrolled at nine centers in Shanghai .


Eight-hundred-and-twelve ( @ ) were randomized to use male condoms and ECP ( i.e. , Levonorgestrel ) as a back-up to condoms ( the intervention group ) and @ to use male condoms only ( the control group ) , according to their working unit .


Participants were visited at admission and at the end of @ , @ , @ , @ , and @ months .


The cumulative life table rates were calculated for pregnancy and other reasons for discontinuation .


The gross cumulative life table rates showed that the cumulative discontinuation rates for all reasons during the year of follow-up in the condoms plus emergency contraception group and the condoms only group were @ and @ , respectively , per @ women ( @ = @ , p = @ ) .


The cumulative gross pregnancy rate of the condoms plus emergency contraception group and the condoms only group were @ and @ , respectively , per @ women ( @ = @ , p = @ ) .


The Pearl Index in the condoms plus emergency contraception group and the condoms only group were @ % and @ % , respectively .


Male condoms remain a highly effective contraceptive method for a period of one year while consistently and correctly used .


In addition , the lowest pregnancy rate followed from perfect use condom .


Comorbid substance related disorders are a major health problem for patients in opioid maintenance treatment ( OMT ) .


It was investigated whether a reinforcement scheme adapted to the regulatory and financial restrictions of routine treatment reduces concomitant drug use .


OMT patients from @ clinics who were using cocaine , benzodiazepines , heroin or amphetamines were randomly allocated to either treatment as usual ( n = @ ) or treatment with an additional escalating reinforcement scheme ( n = @ ) in which a patient 's number of weekly take-home dosages was increased after @ , @ , @ and @ consecutive weeks with drug-free urine specimens .


Trial duration was @ weeks .


Completion rates were @ % for controls and @ % in the experimental group .


Mean number of drug-free weeks was @ ( SD @ ) for the control group and @ ( @ ) for the experimental group ( p = @ ) .


The intervention was not effective compared to routine treatment .


Additional features might be necessary to achieve an effect , e.g. a higher frequency of urine sampling or use of other reinforcers .


It has to be further investigated how interventions which have been proven effective in experimental studies can successfully be adapted to routine care conditions .


Corticoids have potent anti-inflammatory effects , which may help in relieving pain and dysfunction associated with lumbar canal stenosis .


We assessed the effectiveness of a decreasing-dose regimen of oral corticoids in the treatment of lumbar canal stenosis in a prospective , double-blind , randomized , placebo-controlled trial .


Sixty-one patients with lumbar canal stenosis ( @-@ years ; canal area < @mm@ at L@/L@ , L@/L@ , and/or L@/S@on magnetic resonance imaging ; and claudication within @m were electronically randomized to an oral corticoid group ( n = @ ) or a placebo group ( n = @ ) .


The treatment group received @mg/kg of oral corticoids daily , with a dose reduction of one-third per week for @weeks .


Patients and controls were assessed by the Short Form @ Health Survey , Roland-Morris Questionnaire , @-min walk test , visual analog scale , and a Likert scale .


All instruments showed similar outcomes for the corticoid and placebo groups ( P > @ ) .


Obese patients exhibited more severe symptoms compared with non-obese patients .


L@/L@ stenosis was associated with more severe symptoms compared with stenosis at other levels .


The oral corticoid regimen used in this study was not effective in the treatment of lumbar canal stenosis .


Use of hypotonic intravenous fluid to maintain hydration in children in hospital has been associated with hyponatraemia , leading to neurological morbidity and mortality .


We aimed to assess whether use of fluid solutions with a higher sodium concentration reduced the risk of hyponatraemia compared with use of hypotonic solutions .


We did a randomised controlled double-blind trial of children admitted to The Royal Children 's Hospital ( Melbourne , VIC , Australia ) who needed intravenous maintenance hydration for @ h or longer .


With an online randomisation system that used unequal block sizes , we randomly assigned patients ( @:@ ) to receive either isotonic intravenous fluid containing @ mmol/L of sodium ( Na@ ) or hypotonic fluid containing @ mmol/L of sodium ( Na@ ) for @ h or until their intravenous fluid rate decreased to lower than @ % of the standard maintenance rate .


We stratified assignment by baseline sodium concentrations .


Study investigators , treating clinicians , nurses , and patients were masked to treatment assignment .


The primary outcome was occurrence of hyponatraemia ( serum sodium concentration < @ mmol/L with a decrease of at least @ mmol/L from baseline ) during the treatment period , analysed by intention to treat .


The trial was registered with the Australian New Zealand Clinical Trials Registry , number ACTRN@ .


Between Feb @ , @ , and Jan @ , @ , we randomly assigned @ patients .


Of these patients , primary outcome data were available for @ who received Na@ and @ who received Na@ .


Fewer patients given Na@ than those given Na@ developed hyponatraemia ( @ patients -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; odds ratio -LSB- OR -RSB- @ , @ % CI @-@ ; p = @ ) .


No clinically apparent cerebral oedema occurred in either group .


Eight patients in the Na@ group ( two potentially related to intravenous fluid ) and four in the Na@ group ( none related to intravenous fluid ) developed serious adverse events during the treatment period .


One patient in the Na@ had seizures during the treatment period compared with seven who received Na@ .


Use of isotonic intravenous fluid with a sodium concentration of @ mmol/L had a lower risk of hyponatraemia without an increase in adverse effects than did fluid containing @ mmol/L of sodium .


An isotonic fluid should be used as intravenous fluid for maintenance hydration in children .


In a phase @ study , the inhibition of the interleukin-@A receptor improved signs and symptoms of psoriatic arthritis .


We sought to evaluate the efficacy and safety of secukinumab , an anti-interleukin-@A monoclonal antibody , in such patients .


In this double-blind , phase @ study , @ patients with psoriatic arthritis were randomly assigned in a @:@:@ ratio to receive intravenous secukinumab ( at a dose of @ mg per kilogram ) at weeks @ , @ , and @ , followed by subcutaneous secukinumab at a dose of either @ mg or @ mg every @ weeks , or placebo .


Patients in the placebo group were switched to subcutaneous secukinumab at a dose of @ mg or @ mg at week @ or @ , depending on clinical response .


The primary end point was the proportion of patients with an American College of Rheumatology @ ( ACR@ ) response at week @ , defined as a @ % improvement from baseline in the number of tender and swollen joints and at least three other important domains .


ACR@ response rates at week @ were significantly higher in the group receiving secukinumab at doses of @ mg ( @ % ) and @ mg ( @ % ) than in those receiving placebo ( @ % ) ( P < @ for both comparisons with placebo ) .


Secondary end points , including the ACR@ response and joint structural damage , were significantly better in the secukinumab groups than in the placebo group .


Improvements were sustained through @ weeks .


Infections , including candida , were more common in the secukinumab groups .


Throughout the study ( mean secukinumab exposure , @ days ; mean placebo exposure , @ days ) , four patients in the secukinumab groups had a stroke ( @ per @ patient-years ; @ % confidence interval -LSB- CI -RSB- , @ to @ ) , and two had a myocardial infarction ( @ per @ patient-years ; @ % CI , @ to @ ) , as compared with no patients in the placebo group .


Secukinumab was more effective than placebo in patients with psoriatic arthritis , which validates interleukin-@A as a therapeutic target .


Infections were more common in the secukinumab groups than in the placebo group .


The study was neither large enough nor long enough to evaluate uncommon serious adverse events or the risks associated with long-term use .


( Funded by Novartis Pharma ; ClinicalTrials.gov number , NCT@ . )


Does substituting @ g corifollitropin alfa for @ IU follitropin beta during the first @ days of ovarian stimulation in proven poor responders , result in retrieval of a non-inferior number ( < @ fewer ) of cumulus oocyte complexes ( COCs ) ?


A single s.c. dose of @ g corifollitropin alfa on the first day of ovarian stimulation , followed if necessary , from Day @ onwards , with @ IU of follitropin beta/day , is not inferior to daily doses of @ IU follitropin beta .


The @ % CI of the difference between medians in the number of oocytes retrieved was -@ to +@ within the safety margin of @ .


Recent data from retrospective studies suggest that the use of corifollitropin alfa in poor responders is promising since it could simplify ovarian stimulation without compromising its outcome .


Seventy-nine women with previous poor ovarian response undergoing ICSI treatment were enrolled in this open label , non-inferiority , randomized clinical trial ( RCT ) .


Inclusion criteria were : previous poor response to ovarian stimulation ( @ COCs ) after maximal stimulation , age < @ years , regular spontaneous menstrual cycle , body mass index : @-@ kg/m ( @ ) and basal follicle stimulating hormone @ IU/l .


On Day @ of the menstrual cycle , patients were administered either a single s.c dose of @ g corifollitropin alfa ( n = @ ) or a fixed daily dose of @ IU of follitropin beta ( n = @ ) .


In the corifollitropin alfa group , @ IU of follitropin beta were administered from Day @ of stimulation until the day of human chorionic gonadotrophin ( hCG ) administration , if necessary .


To inhibit premature luteinizing hormone surge , the gonadotrophin releasing hormone antagonist ganirelix was used .


Triggering of final oocyte maturation was performed using @ g of recombinant hCG , when at least two follicles reached @ mm in mean diameter .


The number of COCs retrieved was not statistically different between the corifollitropin alfa and the follitropin beta groups -LSB- Median @ versus @ , @ % CI @-@ , @-@ , respectively , P = @ -RSB- .


The @ % CI of the difference between medians in the number of oocytes retrieved was -@ to +@ .


A multivariable analysis adjusting for all the potential baseline differences confirmed this finding .


No significant difference was observed regarding the probability of live birth between the corifollitropin alfa and the follitropin beta group ( live birth per patient reaching oocyte retrieval : @ versus @ % , respectively , difference +@ % , @ % CI : -@ to +@ ) .


The present study was not powered to test a smaller difference ( e.g. @ COC ) in terms of COCs retrieved as well as to show potential differences in the probability of pregnancy .


Moreover , it would be interesting to assess whether the continuation of stimulation in the long acting FSH arm , where necessary , with @ IU instead of @ IU of follitropin beta would have altered the direction or the magnitude of the effect of the type of FSH , observed on the number of COCs retrieved .


Corifollitropin alfa simplifies IVF treatment because it is administered in a GnRH antagonist protocol and replaces seven daily FSH injections with a single one of a long acting FSH without compromising the outcome .


It could greatly reduce the burden of treatment for poor responders and this deserves further investigation .


Recently , a number of studies using intra-articular application of tranexamic acid ( IA-TXA ) , with different dosage and techniques , successfully reduced postoperative blood loss in total knee replacement ( TKR ) .


However , best of our knowledge , the very low dose of IA-TXA with drain clamping technique in conventional TKR has not been yet studied .


This study aimed to evaluate the effectiveness and dose-response effect of two low-dose IA-TXA regimens in conventional TKR on blood loss and blood transfusion reduction .


Between @ and @ , a triple-blinded randomized controlled study was conducted in @ patients undergoing conventional TKR .


The patients were allocated into three groups according to intra-articular solution received : Control group ( physiologic saline ) , TXA-@ group ( TXA @ mg ) , and TXA-@ group ( TXA @ mg ) .


The solution was injected after wound closure followed by drain clamping for @ hours .


Blood loss and transfusion were recorded .


Duplex ultrasound was performed .


Functional outcome and complication were followed for one year .


There were forty-five patients per groups .


The mean total hemoglobin loss was @ g/dL in control group compared with @ g/dL in both TXA groups ( p > @ ) .


Ten patients ( @ % , control ) , six patients ( @ % , TXA-@ ) and none ( TXA-@ ) required transfusion ( p = @ ) .


Thromboembolic events were detected in @ patients ( @ controls , @ TXA-@ , and @ TXA-@ ) .


Functional outcome was non-significant difference between groups .


Combined low-dose IA-TXA , as @ mg , with @-hour clamp drain is effective for reducing postoperative blood loss and transfusion in conventional TKR without significant difference in postoperative knee function or complication .


Although previous studies have suggested the potential advantages of albumin administration in patients with severe sepsis , its efficacy has not been fully established .


In this multicenter , open-label trial , we randomly assigned @ patients with severe sepsis , in @ intensive care units ( ICUs ) , to receive either @ % albumin and crystalloid solution or crystalloid solution alone .


In the albumin group , the target serum albumin concentration was @ g per liter or more until discharge from the ICU or @ days after randomization .


The primary outcome was death from any cause at @ days .


Secondary outcomes were death from any cause at @ days , the number of patients with organ dysfunction and the degree of dysfunction , and length of stay in the ICU and the hospital .


During the first @ days , patients in the albumin group , as compared with those in the crystalloid group , had a higher mean arterial pressure ( P = @ ) and lower net fluid balance ( P < @ ) .


The total daily amount of administered fluid did not differ significantly between the two groups ( P = @ ) .


At @ days , @ of @ patients ( @ % ) in the albumin group and @ of @ ( @ % ) in the crystalloid group had died ( relative risk in the albumin group , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


At @ days , @ of @ patients ( @ % ) in the albumin group and @ of @ ( @ % ) in the crystalloid group had died ( relative risk , @ ; @ % CI , @ to @ ; P = @ ) .


No significant differences in other secondary outcomes were observed between the two groups .


In patients with severe sepsis , albumin replacement in addition to crystalloids , as compared with crystalloids alone , did not improve the rate of survival at @ and @ days .


( Funded by the Italian Medicines Agency ; ALBIOS ClinicalTrials.gov number , NCT@ . )


To assess the most effective local analgesia during transrectal ultrasound-guided prostate biopsy .


A total of @ consecutive patients undergoing transrectal ultrasound-guided prostate biopsy for elevated prostate-specific antigen levels and/or a suspicious digital rectal examination were randomized to three groups .


Patients received a @-mg lidocaine suppository ( group @ , n = @ ) , a periprostatic nerve block ( @-mL injection of lidocaine hydrochloride ; group @ , n = @ ) or a combination of both ( group @ , n = @ ) before a @-core transrectal ultrasound-guided biopsy .


A total of @ % ( n = @ ) of the patients underwent their first biopsy , @ % ( n = @ ) their second and @ % ( n = @ ) the third .


Pain was evaluated on a @-point visual analog scale for each step of the procedure .


Prostate-specific antigen values ranged from @ to @ ( mean -LSB- SD -RSB- @ ng/mL -LSB- @ ng/mL -RSB- ) .


Comparison of the median visual analog scale scores between groups @ and @ showed a significant difference ( P = @ ) .


The differences in the outcomes between groups @ and @ ( P = @ ) , and groups @ and @ ( P = @ ) were also significant .


Patients of group @ had the best output corresponding to the pain sensations and therefore the lowest visual analog scale scores .


The combination of lidocaine suppository and periprostatic lidocaine infiltration is more effective for pain control than either lidocaine suppository or periprostatic lidocaine infiltration alone in patients undergoing transrectal ultrasound-guided prostate biopsy .


We hypothesized that arthroscopic rotator cuff repairs using leukocyte - and platelet-rich fibrin ( L-PRF ) in a standardized , modified protocol is technically feasible and results in a higher vascularization response and watertight healing rate during early healing .


Twenty patients with chronic rotator cuff tears were randomly assigned to @ treatment groups .


In the test group ( N = @ ) , L-PRF was added in between the tendon and the bone during arthroscopic rotator cuff repair .


The second group served as control ( N = @ ) .


They received the same arthroscopic treatment without the use of L-PRF .


We used a double-row tension band technique .


Clinical examinations including subjective shoulder value , visual analog scale , Constant , and Simple Shoulder Test scores and measurement of the vascularization with power Doppler ultrasonography were made at @ and @ weeks .


There have been no postoperative complications .


At @ and @ weeks , there was no significant difference in the clinical scores between the test and the control groups .


The mean vascularization index of the surgical tendon-to-bone insertions was always significantly higher in the L-PRF group than in the contralateral healthy shoulders at @ and @ weeks ( P = @ ) .


Whereas the L-PRF group showed a higher vascularization compared with the control group at @ weeks ( P = @ ) , there was no difference after @ weeks of follow-up ( P = @ ) .


Watertight healing was obtained in @ % of the repaired cuffs .


Arthroscopic rotator cuff repair with the application of L-PRF is technically feasible and yields higher early vascularization .


Increased vascularization may potentially predispose to an increased and earlier cellular response and an increased healing rate .


The measurement of mechanosensitivity is a key method for the study of pain in animal models .


This is often accomplished with the use of von Frey filaments in an up-down testing paradigm .


The up-down method described by Chaplan et al. ( J Neurosci Methods @:@ -@ , @ ) for mechanosensitivity testing in rodents remains one of the most widely used methods for measuring pain in animals .


However , this method results in animals receiving a varying number of stimuli , which may lead to animals in different groups receiving different testing experiences that influences their later responses .


To standardize the measurement of mechanosensitivity we developed a simplified up-down method ( SUDO ) for estimating paw withdrawal threshold ( PWT ) with von Frey filaments that uses a constant number of five stimuli per test .


We further refined the PWT calculation to allow the estimation of PWT directly from the behavioral response to the fifth stimulus , omitting the need for look-up tables .


The PWT estimates derived using SUDO strongly correlated ( r > @ ) with the PWT estimates determined with the conventional up-down method of Chaplan et al. , and this correlation remained very strong across different levels of tester experience , different experimental conditions , and in tests from both mice and rats .


The two testing methods also produced similar PWT estimates in prospective behavioral tests of mice at baseline and after induction of hyperalgesia by intraplantar capsaicin or complete Freund 's adjuvant .


SUDO thus offers an accurate , fast and user-friendly replacement for the widely used up-down method of Chaplan et al. .


It is unclear if holding angiotensin-converting enzyme inhibitors ( ACEI ) or angiotensin receptor blockers ( ARB ) prior to coronary angiography reduces contrast-induced acute kidney injury ( AKI ) .


We undertook a randomized trial to investigate the effect of holding ACEI/ARB therapy prior to coronary angiography on the incidence of AKI .


We randomly assigned @ patients with moderate renal insufficiency ( creatinine @ mg/dL within @ months and/or documented creatinine @ mg/dL within @ week before cardiac catheterization ) to hold ACEI/ARB @ hours preprocedure or continue ACEI/ARB .


The primary outcome was the incidence of AKI defined as an absolute rise in serum creatinine of @ mg/dL from baseline and/or a relative rise in serum creatinine of @ % compared with baseline measured at @ to @ hours postcardiac catheterization .


All patients were taking an ACEI ( @ % ) or ARB ( @ % ) prior to randomization .


At @ to @ hours , the primary outcome occurred in @ % of patients who continued ACEI/ARB compared with @ % of the patients who held ACEI/ARB ( hazard ratio @ , @ % CI @-@ @ , P = @ ) .


In a prespecified secondary outcome , there was a lower rise in mean serum creatinine after the procedure in patients who held ACEI/ARB ( @ @ vs @ @ mg/dL , P = @ ) .


The clinical composite of death , myocardial infarction , ischemic stroke , congestive heart failure , rehospitalization for cardiovascular cause , or need for dialysis preprocedure occurred in @ % who continued ACEI/ARB compared with @ % who held the ACEI/ARB ( hazard ratio @ , @ % CI @-@ @ , P = @ ) .


In this pilot study of patients with moderate renal insufficiency undergoing cardiac catheterization , with-holding ACEI/ARB resulted in a non-significant reduction in contrast-induced AKI and a significant reduction in post-procedural rise of creatinine .


This low cost intervention could be considered when referring a patient for cardiac catheterization .


Few studies have evaluated the possible beneficial effect of the administration of stem cells in the early stages of stroke .


Intravenous administration of allogeneic mesenchymal stem cells ( MSCs ) from adipose tissue in patients with acute stroke could be a safe therapy for promoting neurovascular unit repair , consequently supporting better functional recovery .


We aim to assess the safety and efficacy of MSC administration and evaluate its potential as a treatment for cerebral protection and repair .


A Phase IIa , prospective , randomized , double-blind , placebo-controlled , single-center , pilot clinical trial .


Twenty patients presenting acute ischemic stroke will be randomized in a @:@ proportion to treatment with allogeneic MSCs from adipose tissue or to placebo ( or vehicle ) administered as a single intravenous dose within the first @ weeks after the onset of stroke symptoms .


The patients will be followed up for @ years .


Primary outcomes for safety analysis : adverse events ( AEs ) and serious AEs ; neurologic and systemic complications , and tumor development .


Secondary outcomes for efficacy analysis : modified Rankin Scale ; NIHSS ; infarct size ; and biochemical markers of brain repair ( vascular endothelial growth factor , brain-derived neurotrophic factor , and matrix metalloproteinases @ ) .


To our knowledge , this is the first , phase II , pilot clinical trial to investigate the safety and efficacy of intravenous administration of allogeneic MSCs from adipose tissue within the first @ weeks of stroke .


In addition , its results will help us define the best criteria for a future phase III study .


This international phase III trial ( Investigating Torisel As Second-Line Therapy -LSB- INTORSECT -RSB- ) compared the efficacy of temsirolimus ( mammalian target of rapamycin inhibitor ) and sorafenib ( vascular endothelial growth factor receptor -LSB- VEGFR -RSB- tyrosine kinase inhibitor ) as second-line therapy in patients with metastatic renal cell carcinoma ( mRCC ) after disease progression on sunitinib .


In total , @ patients were randomly assigned @:@ to receive intravenous temsirolimus @ mg once weekly ( n = @ ) or oral sorafenib @ mg twice per day ( n = @ ) , with stratification according to duration of prior sunitinib therapy ( or > @ days ) , prognostic risk , histology ( clear cell or non-clear cell ) , and nephrectomy status .


The primary end point was progression-free survival ( PFS ) by independent review committee assessment .


Safety , objective response rate ( ORR ) , and overall survival ( OS ) were secondary end points .


Primary analysis revealed no significant difference between treatment arms for PFS ( stratified hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; two-sided P = @ ) or ORR .


Median PFS in the temsirolimus and sorafenib arms were @ and @ months , respectively .


There was a significant OS difference in favor of sorafenib ( stratified HR , @ ; @ % CI , @ to @ ; two-sided P = @ ) .


Median OS in the temsirolimus and sorafenib arms was @ and @ months , respectively .


Safety profiles of both agents were consistent with previous studies .


In patients with mRCC and progression on sunitinib , second-line temsirolimus did not demonstrate a PFS advantage compared with sorafenib .


The longer OS observed with sorafenib suggests sequenced VEGFR inhibition may benefit patients with mRCC .


Parathyroidectomy in patients with hyperparathyroidism can produce subsequent increases in bone mineral density ( BMD ) .


Ronacaleret , a selective calcium-sensing receptor antagonist that stimulates endogenous parathyroid hormone release , induced mild hyperparathyroidism .


The aim of this study is to evaluate whether BMD changes after cessation of ronacaleret treatment .


Observational , off-treatment , extension of a randomized , placebo-controlled , dose-ranging phase II trial .


Fifteen academic centers in seven countries .


Postmenopausal women with low BMD ; @ out of @ women in the parent study were enrolled in the extension study .


Subjects were treated with ronacaleret @mg ( n = @ ) , @mg ( n = @ ) , @mg ( n = @ ) , or @mg ( n = @ ) once daily , alendronate @mg ( n = @ ) once weekly , or matching placebo ( n = @ ) for @-@months ; BMD was measured after discontinuation of ronacaleret or alendronate treatment .


Mean percent change in lumbar spine areal BMD by dual-energy X-ray absorptiometry at @-@months after discontinuing ronacaleret or alendronate compared with the @ - to @-month BMD measurement of the parent study .


At the lumbar spine , all doses of ronacaleret resulted in gains in BMD while on treatment .


These increases in BMD were maintained or increased after discontinuation of ronacaleret .


All doses of ronacaleret caused bone loss at the total hip while on active treatment .


However , there was an attenuation of this loss in the off-treatment extension study .


The gain in BMD at the lumbar spine was maintained post-treatment and the loss of BMD at the total hip was attenuated .


We hypothesize that there may have been some bone remineralization after cessation of ronacaleret .


To study the influence of aerobic exercise training on brain-derived neurotrophic factor ( BDNF ) , insulin resistance , and lipid profile in middle-aged men diagnosed with metabolic syndrome ( MetS ) .


This is an experimental repeated measure study .


Subjects participated in aerobic training programs ( @ sessions of @-@ minutes per session ) in Guilan University gymnasium and court .


A total of @ middle-aged men ( @-@ years old ) diagnosed with MetS participated .


We randomly divided @ middle-aged men with MetS into exercise and control groups .


The exercise group followed an aerobic training program ( @ sessions , @/wk ) at @ % to @ % of V -LSB- Combining Dot Above -RSB- O@ peak ( @-@ minutes per session ) and @ weeks of detraining .


Blood samples were collected at baseline , end of the training , and detraining .


High BDNF level in patients with MetS and its reduction after chronic aerobic exercise .


Aerobic training significantly decreased all the metabolic risk factors , including overall MetS z score , insulin resistance , and lipid profile ( P < @ ) .


After the detraining period , plasma triglyceride , high-density lipoprotein , and also overall MetS z score remained unchanged ( P < @ ) ; however , serum BDNF , which was decreased by aerobic training ( P = @ ) , restored to the baseline at the end of the detraining ( P = @ ) .


Improved metabolic risk factors along with decreased serum BDNF in response to aerobic training and the opposite direction during the detraining emphasize the importance of physical activity in the treatment of MetS and prevention of related diseases .


The aims of this study were to compare strut tissue coverage at six-month follow-up after Nobori biolimus-eluting stent ( N-BES ) versus sirolimus-eluting stent ( SES ) implantation .


A total of @ patients with a single stenotic lesion requiring revascularisation were randomly assigned to either N-BES ( n = @ ) or SES ( n = @ ) .


Baseline optical coherence tomography ( OCT ) was performed post stent implantation , and follow-up OCT was scheduled at six months .


Post-intervention and follow-up OCT analyses were available in @ ( @ % ) and @ ( @ % ) patients , respectively .


The primary endpoint was the percentage of uncovered struts at follow-up OCT in all cross-sections with analysis of @ mm longitudinal intervals .


In addition , an OCT contour plot analysis was constructed to investigate the distribution patterns of uncovered struts .


The percentage of uncovered struts of N-BES was significantly lower versus SES ( @ % versus @ % , respectively , p = @ ) .


N-BES showed a greater NIH thickness than SES ( median -LSB- interquartile range -RSB- @ m -LSB- @-@ @ -RSB- versus @ m -LSB- @-@ @ -RSB- , p = @ ) .


Contour plot analyses showed a lower incidence of a diffuse distribution pattern of uncovered struts ( @ % versus @ % , respectively , p = @ ) .


This randomised OCT study showed that N-BES had a significantly lower percentage of uncovered struts , and less common diffuse distribution pattern of uncovered struts versus SES .


To explore the necessity of interrupting nerve fibers of bypass thoracic sympathetic chain during edoscopic sympathicotomy ( ETS ) for palmar hyperhidrosis .


Randomized controlled trial was performed for @ patients of severe palmar hyperhidrosis from January @ to June @ .


They were randomly divided into @ groups of R@ thoracic sympathctomy ( R@ ) and R@ thoracic sympathicotomy plus bypass fiber resection at the same level ( R@ + ) ( n = @ each ) .


Clinical observations were recorded during a follow-up period of @ years .


The curative rates of palmar and axillary hyperhidrosis were @ % for two groups .


No statistically significant inter-group difference existed in left hand temperature increase after transecting thoracic sympathetic nerve ( @ @ C vs @ @ C ) , right hand increase ( @ @ C vs @ @ C ) , incidence of compensatory hyperhidrosis ( @ % vs @ % ) , recurrence rate ( @ % vs @ % ) and postoperative satisfaction rate ( @ % vs @ % ) .


But pain scores of R@ group was significantly lower than those of R@ + group ( @ @ vs @ @ , P < @ ) .


Simple transaction of thoracic sympathetic chain during ETS is sufficient in the treatment of palmar hyperhidrosis .


And it is unnecessary to transect bypass fibers .


Most blood donors stop donating blood at the beginning of their donor career .


This intervention study aims to increase first-time return behaviour of newly registered donors using implementation intentions and explicit commitment techniques .


Newly registered donors ( N = @ ) received an extra information sheet during their medical check-up wherein implementation intentions and explicit commitment techniques were tested .


Donors were randomly assigned to either the control condition , information sheet only condition , information sheet with implementation intentions condition , information sheet with explicit commitment condition , or information sheet with both implementation intentions and explicit commitment condition .


Logistic regression analyses examined actual first-time return behaviour after an appeal to donate blood .


Donors in the information sheet with both implementation intentions and explicit commitment condition had an @ % higher return rate than donors in the control condition .


Logistic regression analyses revealed that the information sheet with both implementation intentions and explicit commitment condition significantly increased the odds on return behaviour compared with the control condition ( OR = @ , @ % CI = @-@ @ ) .


This study successfully increased actual first-time return behaviour of newly registered donors by using both implementation intentions and explicit commitment techniques .


The prognoses of symptomatic and asymptomatic intracranial atherosclerotic stenosis ( ICAS ) differ .


Understanding the underlying pathomechanisms and predictors of progression or regression may help to clarify the differences .


We herein attempted to compare the course and predictors of symptomatic ICAS to those of coexisting asymptomatic ICAS .


This was a post-hoc analysis of the ` Trials of Cilostazol in Symptomatic intracranial arterial stenosis-@ ( TOSS-@ ) ' study , which recruited patients with acute symptomatic ICAS receiving intensive medical treatment .


Changes in the status of ICAS were classified as being indicative of regression , progression or no changes .


Univariate and multivariate ordinal regression analyses were performed to identify predictors of symptomatic and asymptomatic ICAS based on clinical , laboratory and radiologic data .


Of the @ patients , symptomatic ICAS demonstrated regression in @ ( @ % ) cases and progression in @ ( @ % ) cases .


Among these patients , @ ( @ % ) had asymptomatic ICAS , which regressed in @ ( @ % ) cases and progressed in @ ( @ % ) cases .


Severe baseline stenosis , a high high-density lipoprotein ( HDL ) cholesterol level and the use of cilostazol were found to be independently associated with a favorable course of symptomatic ICAS ( p@ @ , p = @ and p = @ , respectively ) .


Regarding asymptomatic ICAS , severe stenosis , the use of angiotensin receptor antagonists and a low fasting glucose level were associated with a favorable course ( p@ @ , p = @ and p = @ , respectively ) .


Changes in atherosclerosis are more dynamic in patients with symptomatic ICAS , and the predictors of symptomatic and asymptomatic ICAS differ .


In this study , changes in the status of symptomatic ICAS were associated with the level of HDL cholesterol , which is known to affect the regression of atherosclerosis and vascular remodeling .


Selective neck dissection ( SND ) in clinical N@ ( cN@ ) cases of oral squamous cell carcinoma ( SCC ) has been performed by surgeons using a retroauricular or modified facelift approach with robotic or endoscopic assistance .


However , these procedures provide cosmetic satisfaction at the cost of possible maximal invasiveness .


In this prospective study , we introduced and evaluated the feasibility as well as surgical invasiveness and cosmetic outcome of endoscopically-assisted SND via a small submandibular approach .


Forty-four patients with cT@-@N@ oral SCC ( OSCC ) were randomly divided into two groups of endoscopically-assisted SND and conventional SND .


Perioperative and postoperative outcomes of patients were evaluated , including the length of the incision , operating time for neck dissection , estimated blood loss during the operation , amount and duration of drainage , total hospitalization period , total number of lymph nodes retrieved , satisfaction scores based on the cosmetic results , perioperative local complications , shoulder syndrome , and follow-up information .


The mean operation time in the endoscopically-assisted group ( @ min ) was longer than that in the conventional group ( @ min ) .


However , the mean length of the incision was @ cm in the endoscopically-assisted SND group , and the amount and duration of drainage , total hospital stay , postoperative shoulder pain score , and cosmetic outcomes were superior in the endoscopically-assisted SND group .


Additionally , the retrieved lymph nodes and complications were comparable .


Endoscopically-assisted SND via a small submandibular approach had a longer operation time than the conventional approach .


However , endoscopically-assisted SND was feasible and reliable while providing minimal invasiveness and satisfactory appearance .


The Radiation Therapy Oncology Group @-@ clinical trial demonstrated the superiority of standard @-fluorouracil/mitomycin-C over @-fluorouracil/cisplatin in combination with radiation in the treatment of anal squamous cell cancer .


Tumor size ( > @ cm ) and lymph node metastases are associated with disease progression .


There may be key molecular differences ( eg , DNA methylation changes ) in tumors at high risk for progression .


The objectives of this study were to determine whether there are differences in DNA methylation at individual CpG sites and within genes among locally advanced anal cancers , with large tumor size and/or nodal involvement , compared with those that are less advanced .


This was a case-case study among @ patients defined as high risk ( tumor size > @ cm and/or nodal involvement ; n = @ ) or low risk ( @ cm , node negative ; n = @ ) within the mitomycin-C arm of the Radiation Therapy Oncology Group @-@ trial .


DNA methylation was measured using the Illumina HumanMethylation@ Array .


The study was conducted in a tertiary care cancer center in collaboration with a national clinical trials cooperative group .


The patients consisted of @ women and @ men with a median age of @ years ( range , @-@ years ) .


DNA methylation differences at individual CpG sites and within genes between low - and high-risk patients were compared using the Mann-Whitney test ( p < @ ) .


A total of @ CpG loci were differentially methylated ( @ increased and @ decreased ) in high - versus low-risk cases .


Genes harboring differentially methylated CpG sites included known tumor suppressor genes and novel targets .


This study only included patients in the mitomycin-C arm with tumor tissue ; however , this sample was representative of the trial .


This is the first study to apply genome-wide methylation analysis to anal cancer .


Biologically relevant differences in methylated targets were found to discriminate locally advanced from early anal cancer .


Epigenetic events likely play a significant role in the progression of anal cancer and may serve as potential biomarkers .


Orthotopic liver transplantation ( OLT ) has become the therapeutic option of choice for end-stage liver disease .


The aim of this study was to investigate the changes of splenic morphology , signal-to-noise ratio ( SNR ) , contrast-to-noise ratio ( CNR ) , apparent diffusion coefficient ( ADC ) values and explore their value in evaluating the therapeutic effects of orthotopic liver transplantation ( OLT ) on portal hypertension at @ Tesla MRI .


Twenty patients with portal hypertension undergoing OLT were included in this study .


Conventional MRI and diffusion-weighted image ( DWI ) ( b value = @ s/mm ( @ ) ) sequences were applied on each patient before and after OLT , and these patients were referred to as the preoperative and postoperative groups .


Twenty healthy individuals were selected as the normal group .


After image acquisition , the splenic width ( W ) , thickness ( T ) , length ( L ) , the diameter of the portal vein ( PD ) and splenic vein ( SD ) were measured and the splenic volume ( V ) was calculated .


The SNR and CNR were measured on T@WI .


The ADC maps were calculated using the b@ in DWIs and the ADC values were measured .


Compared with the preoperative group , the splenic V , PD and SD decreased significantly in the postoperative group ( P < @ ) .


All splenic morphological values were significantly different between preoperative and normal groups ( P < @ ) .


The splenic L and V were significantly different ( P < @ ) between postoperative and normal groups .


The SNR and CNR values were @ @ and @ @ , @ @ and @ @ , @ @ and @ @ in the preoperative , postoperative and normal groups , respectively .


Both SNR and CNR decreased after OLT , but they was still higher than the normal values .


The SNR was significantly different between any two groups ( P < @ ) .


The CNR was significantly different ( P < @ ) between the preoperative and postoperative groups , preoperative and normal groups .


The splenic ADC values were ( @ @ ) @ ( -@ ) mm ( @ ) / s , ( @ @ ) @ ( -@ ) mm ( @ ) / s and ( @ @ ) @ ( -@ ) mm ( @ ) / s in the preoperative , postoperative and normal groups , respectively .


The difference of ADC values were significant ( P < @ ) between the preoperative and postoperative groups , and the preoperative and normal groups .


OLT is an effective method of treatment for portal hypertension .


In addition to dramatically decreasing the splenic V , it can also decrease the splenic SNR , CNR and ADC values in patients with portal hypertension .


The changes of splenic SNR , CNR and ADC after OLT may be helpful in providing noninvasive supplementary information in assessing the therapeutic effect of OLT on portal hypertension .


Modic changes ( MC ) are associated with low back pain ( LBP ) , but effective treatments are lacking .


The aim of this randomized , placebo-controlled , double-blinded trial was to evaluate the efficacy of zoledronic acid ( ZA ) for chronic LBP among patients with MC in magnetic resonance imaging ( MRI ) .


Inclusion criteria were LBP lasting @ months , with an intensity of @ on a @-cm VAS or an Oswestry Disability Index ( ODI ) of @ % , and MC in MRI .


Patients were randomized into single intravenous infusion of ZA @ mg ( n = @ ) , or placebo ( n = @ ) groups .


The primary outcome was LBP intensity , secondary outcomes leg pain intensity , ODI , health-related quality of life ( RAND-@ ) , lumbar flexibility , sick leaves and use of pain medication .


The treatment differences at one month and one year were analysed using ANCOVA with adjustment for the baseline score .


The mean difference ( MD ) between the groups in the primary outcome , intensity of LBP , was @ ( @ % confidence intervals ( CI ) @ to @ ) in favour of ZA at one month .


We observed no significant between-group difference in the intensity of LBP at one year ( MD @ ; @ % CI -@ to @ ) or in secondary outcomes at any time point except that @ % of patients in the ZA group used non-steroidal anti-inflammatory drugs at one year compared to @ % in the placebo group ( P = @ ) .


Acute phase reactions ( fever , flu-like symptoms , arthralgia ) emerged in @ % of the patients in the ZA group , compared to @ % in the placebo group .


ZA was effective in reducing the intensity of LBP in the short term and in reducing the use of NSAIDs within the time span of one year among patients with chronic LBP and MC confirmed in MRI .


Although the results seem encouraging , larger studies are required to analyse the effectiveness and safety of ZA for patients with MC .


Postoperative ileus ( POI ) is a common complication following colorectal surgery that delays recovery and increases length of hospital stay .


Gum chewing may reduce POI and therefore enhance recovery after surgery .


The aim of the study was to evaluate the effect of gum chewing on POI , length of hospital stay and inflammatory parameters .


Patients undergoing elective colorectal surgery in one of two centres were randomized to either chewing gum or a dermal patch ( control ) .


Chewing gum was started before surgery and stopped when oral intake was resumed .


Primary endpoints were POI and length of stay .


Secondary endpoints were systemic and local inflammation , and surgical complications .


Gastric emptying was measured by ultrasonography .


Soluble tumour necrosis factor receptor @ ( TNFRSF@A ) and interleukin ( IL ) @ levels were measured by enzyme-linked immunosorbent assay .


Between May @ and September @ , @ patients were randomized to chewing gum ( @ ) or dermal patch ( control group ; @ ) .


Mean ( s.d. ) length of hospital stay was shorter in the chewing gum group than in controls , but this difference was not significant : @ ( @ ) versus @ ( @ ) days respectively .


Some @ ( @ per cent ) of @ analysed patients allocated to chewing gum developed POI compared with @ ( @ per cent ) of @ patients in the control group ( P = @ ) .


More patients in the chewing gum group first defaecated within @ days of surgery ( @ versus @ per cent ; P = @ ) and passed first flatus within @h ( @ versus @ per cent ; P = @ ) .


The decrease in antral area measured by ultrasonography following a standard meal was significantly greater among patients who chewed gum : median @ ( range -@ to @ ) per cent compared with @ ( range -@ to @ ) per cent in controls ( P = @ ) .


Levels of IL-@ ( @ versus @pg/ml ; P = @ ) and TNFRSF@A ( @ versus @ng/ml ; P = @ ) were lower among patients in the chewing gum group .


Fewer patients in this group developed a grade IIIb complication ( @ of @ versus @ of @ ; P = @ ) .


Gum chewing is a safe and simple treatment to reduce POI , and is associated with a reduction in systemic inflammatory markers and complications .


Current guidelines recommend at least @ hours of electrocardiographic ( ECG ) monitoring after an ischemic stroke to rule out atrial fibrillation .


However , the most effective duration and type of monitoring have not been established , and the cause of ischemic stroke remains uncertain despite a complete diagnostic evaluation in @ to @ % of cases ( cryptogenic stroke ) .


Detection of atrial fibrillation after cryptogenic stroke has therapeutic implications .


We conducted a randomized , controlled study of @ patients to assess whether long-term monitoring with an insertable cardiac monitor ( ICM ) is more effective than conventional follow-up ( control ) for detecting atrial fibrillation in patients with cryptogenic stroke .


Patients @ years of age or older with no evidence of atrial fibrillation during at least @ hours of ECG monitoring underwent randomization within @ days after the index event .


The primary end point was the time to first detection of atrial fibrillation ( lasting > @ seconds ) within @ months .


Among the secondary end points was the time to first detection of atrial fibrillation within @ months .


Data were analyzed according to the intention-to-treat principle .


By @ months , atrial fibrillation had been detected in @ % of patients in the ICM group ( @ patients ) versus @ % of patients in the control group ( @ patients ) ( hazard ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P < @ ) .


By @ months , atrial fibrillation had been detected in @ % of patients in the ICM group ( @ patients ) versus @ % of patients in the control group ( @ patients ) ( hazard ratio , @ ; @ % CI , @ to @ ; P < @ ) .


ECG monitoring with an ICM was superior to conventional follow-up for detecting atrial fibrillation after cryptogenic stroke .


( Funded by Medtronic ; CRYSTAL AF ClinicalTrials.gov number , NCT@ . )


Piriformis muscle injections are most often performed using fluoroscopic guidance ; however , ultrasound ( US ) guidance has recently been described extensively in the literature .


No direct comparisons between the @ techniques have been performed .


Our objective was to compare the efficacy and efficiency of fluoroscopic - and US-guided techniques .


A randomized , comparative trial was carried out to compare the @ techniques .


Twenty-eight patients with a diagnosis of piriformis syndrome , based on history and physical examination , who had failed conservative treatment were enrolled in the study .


Patients were randomized to receive the injection either via US or fluoroscopy .


Injections consisted of @ mL of @ % lidocaine with @ mg of triamcinalone .


The primary outcome measure was numeric pain score , and secondary outcome measures included functional status as measured by the Multidimensional Pain Inventory , patient satisfaction as measured by the Patient Global Impression of Change scale , and procedure timing characteristics .


Outcome data were measured preprocedure , immediately postprocedure , and @ to @ weeks and @ months postprocedure .


We found no statistically significant differences in numeric pain scores , patient satisfaction , procedure timing characteristics , or most functional outcomes when comparing the @ techniques .


Statistically significant differences between the @ techniques were found with respect to the outcome measures of household chores and outdoor work .


Ultrasound-guided piriformis injections provide similar outcomes to fluoroscopically guided injections without differences in imaging , needling , or overall procedural times .


The cost implications of the Outcome Reduction with an Initial Glargine Intervention ( ORIGIN ) trial were evaluated using a prespecified analysis plan .


Purchasing power parity-adjusted country-specific costs were applied to consumed healthcare resources by participants from each country .


Subgroup analyses were conducted on subgroups based on baseline metabolic status and diabetes duration .


The total undiscounted cost per participant in the insulin glargine arm was $ @,@ ( $ @,@ to $ @,@ ) versus $ @,@ ( $ @,@ to $ @,@ ) for standard care , an increase of $ @ ( $ @ to $ @ ; p < @ ) ; the discounted increase was $ @ ( $ @ to $ @ ; P < @ ) .


The greater number of mainly generic oral anti-diabetic agents in the standard group partially offset the higher cost of basal insulin glargine .


As the trial progressed and the standard group required more anti-diabetic medications , the annual cost difference decreased , reaching $ @ ( - $ @ to $ @ ) in the last year .


The subgroup whose baseline diabetes duration was @ years achieved cost-savings during the trial .


From a global perspective basal insulin glargine use in ORIGIN incurred greater costs than standard care using older generic drugs .


Nevertheless , the cost difference fell with time such that the intervention was cost-neutral by the last year .


Social cognition and interaction training ( SCIT ) has shown promise in improving consumers ' social cognition and functioning , in both inpatient and outpatient settings .


This randomized controlled trial examined the effectiveness of SCIT among persons with serious mental illness living in community settings in Israel .


Fifty-five participants in social-mentoring services were assigned randomly to SCIT with social mentoring or to social mentoring only .


Emotion recognition , theory of mind , attributional bias , and social functioning were assessed at baseline ( February @ ) and about six months later , upon completion of the intervention .


Interactions between time of measurement and group were significant for theory of mind and social engagement .


Emotion recognition by the SCIT group improved significantly , but the time group interaction for this variable was not significant .


This study provides preliminary evidence that SCIT plus social mentoring improves social cognition and functioning among persons with severe mental illness who are living in the community .


Health-related and disease-specific quality of life ( HRQoL ) has been increasingly valued as relevant clinical parameter in cystic fibrosis ( CF ) clinical care and clinical trials .


HRQoL measures should assess - among other domains - daily functioning from a patient 's perspective .


However , validation studies for the most frequently used HRQoL questionnaire in CF , the Cystic Fibrosis Questionnaire ( CFQ ) , have not included measures of physical activity or fitness .


The objective of this study was , therefore , to determine the cross-sectional and longitudinal relationships between HRQoL , physical activity and fitness in patients with CF.


Baseline ( n = @ ) and @-month follow-up data ( n = @ ) from patients with CF ( age @ years , FEV@ @ % ) were analysed .


Patients participated in two multi-centre exercise intervention studies with identical assessment methodology .


Outcome variables included HRQoL ( German revised multi-dimensional disease-specific CFQ ( CFQ-R ) ) , body composition , pulmonary function , physical activity , short-term muscle power , and aerobic fitness by peak oxygen uptake and aerobic power .


Peak oxygen uptake was positively related to @ of @ HRQoL scales cross-sectionally ( r = @-@ @ ) .


Muscle power ( r = @-@ @ ) and peak aerobic power ( r = @-@ @ ) were positively related to @ scales each , and reported physical activity to @ scale ( r = @ ) .


Changes in HRQoL-scores were directly and significantly related to changes in reported activity ( r = @-@ @ ) , peak aerobic power ( r = @-@ @ ) , and peak oxygen uptake ( r = @-@ @ ) in @ scales each .


Established associates of HRQoL such as FEV@ or body mass index correlated positively with fewer scales ( all @ < r < @ ) .


HRQoL was associated with physical fitness , especially aerobic fitness , and to a lesser extent with reported physical activity .


These findings underline the importance of physical fitness for HRQoL in CF and provide an additional rationale for exercise testing in this population .


To compare the efficacy and safety of single-dose bimatoprost @ % / timolol @ % preservative-free ( PF ) ophthalmic solution with bimatoprost @ % / timolol @ % ophthalmic solution in patients with open-angle glaucoma or ocular hypertension .


In this multicentre , randomised , parallel-group study , patients were randomised to bimatoprost/timolol PF or bimatoprost/timolol once daily in the morning for @ weeks .


Primary efficacy endpoints , reflecting differing regional regulatory requirements , included change from baseline in worse eye intraocular pressure ( IOP ) in the per-protocol population at week @ , and the average eye IOP at weeks @ , @ and @ in the intent-to-treat population .


@ patients were randomised ( @ to bimatoprost/timolol PF ; @ to bimatoprost/timolol ) ; @ % completed the study .


Both treatment groups showed statistically and clinically significant mean decreases from baseline in worse eye IOP and in average eye IOP at all follow-up time points ( p < @ ) .


Bimatoprost/timolol PF met all pre-established criteria for non-inferiority and equivalence to bimatoprost/timolol .


Ocular adverse events were similar between treatment groups , with conjunctival hyperaemia being the most frequent .


Most were mild or moderate in severity .


Bimatoprost/timolol PF demonstrated non-inferiority and equivalence in IOP lowering compared with bimatoprost/timolol , with no significant differences in safety and tolerability .


Current guidelines recommend treatment of significant coronary artery disease by concomitant coronary artery bypass grafting ( CABG ) in patients undergoing surgical aortic valve replacement .


However there is no consensus as to how best to treat coronary disease in high-risk patients requiring transcatheter aortic valve implantation ( TAVI ) .


The percutaneous coronary intervention prior to transcatheter aortic valve implantation ( ACTIVATION ) trial is a randomized , controlled open-label trial of @ patients randomized to treatment of significant coronary artery disease by percutaneous coronary intervention ( PCI - test arm ) or no PCI ( control arm ) .


Significant coronary disease is defined as @ lesion of @ % severity in a major epicardial vessel or @ % in a vein graft or protected left main stem lesion .


The trial tests the hypothesis that the strategy of performing pre-TAVI PCI is non-inferior to not treating such coronary stenoses with PCI prior to TAVI , with a composite primary outcome of @-month mortality and rehospitalization .


Secondary outcomes include efficacy end-points such as @-day mortality , safety endpoints including bleeding , burden of symptoms , and quality of life ( assessed using the Seattle Angina Questionnaire and the Kansas City Cardiomyopathy Questionnaire ) .


In conclusion , we hope that using a definition of coronary artery disease severity closer to that used in everyday practice by interventional cardiologists - rather than the @ % severity used in surgical guidelines - will provide robust evidence to direct guidelines regarding TAVI therapy and improve its safety and efficacy profile of this developing technique .


Some characteristics of assessments exert a strong influence on how students study .


Understanding these pre-assessment learning effects is of key importance to the designing of medical assessments that foster students ' reasoning abilities .


Perceptions of the task demands of an assessment significantly influence students ' cognitive processes .


However , why and how certain tasks positively ` drive ' learning remain unknown .


Medical tasks can be assessed as coherent meaningful whole tasks ( e.g. examining a patient based on his complaint to find the diagnosis ) or can be divided into simpler part tasks ( e.g. demonstrating the physical examination of a pre-specified disease ) .


Comparing the benefits of whole-task and part-task assessments in a randomised controlled experiment could guide the design of ` assessments for learning ' .


The purpose of this study was to determine whether the knowledge that an objective structured clinical examination ( OSCE ) will contain whole tasks , as opposed to part tasks , increases the use of diagnostic reasoning by medical students when they study for this assessment .


In this randomised , controlled , mixed-methods experiment , @ medical students were randomly paired and filmed while studying together for two imminent physical examination OSCE stations .


Each @-minute study period began with video cues and ended with a questionnaire on cognitive loads .


Cues disclosed either a part-task OSCE station ( examination of a healthy patient ) or a whole-task OSCE station ( hypothesis-driven physical examination -LSB- HDPE -RSB- ) .


In a crossover design , sequences were randomised for both task and content ( shoulder or spine ) .


Two blinded and independent authors scored all @ videos in distinct randomised orders , listening to participants studying freely .


Mentioning a diagnosis in association with a sign was scored as a backward association , and the opposite was scored as a forward association ; both revealed the use of diagnostic reasoning .


Qualitative data were obtained through group interviews .


Studying for whole-task OSCE stations resulted in a greater use of diagnostic reasoning .


Qualitative data triangulate these findings and show the precedence of cues sourced from the ` student grapevine ' .


In comparison with ` traditional ' part-task OSCEs , whole-task OSCEs like the HDPE increase students ' use of diagnostic reasoning during study time .


The interferon-free combination of the protease inhibitor ABT-@ with ritonavir ( ABT-@ / r ) and the NS@A inhibitor ombitasvir ( also known as ABT-@ ) plus the nonnucleoside polymerase inhibitor dasabuvir ( also known as ABT-@ ) and ribavirin has shown efficacy against the hepatitis C virus ( HCV ) in patients with HCV genotype @ infection .


In this phase @ trial , we evaluated this regimen in previously untreated patients with HCV genotype @ infection and no cirrhosis .


In this multicenter , randomized , double-blind , placebo-controlled trial , we assigned previously untreated patients with HCV genotype @ infection , in a @:@ ratio , to an active regimen consisting of a single-tablet coformulation of ABT-@ / r-ombitasvir ( at a once-daily dose of @ mg of ABT-@ , @ mg of ritonavir , and @ mg of ombitasvir ) , and dasabuvir ( @ mg twice daily ) with ribavirin ( in doses determined according to body weight ) ( group A ) or matching placebos ( group B ) .


The patients received the study treatment during a @-week double-blind period .


The primary end point was sustained virologic response at @ weeks after the end of treatment .


The primary analysis compared the response rate in group A with the response rate ( @ % ) in a historical control group of previously untreated patients without cirrhosis who received telaprevir with peginterferon and ribavirin .


Adverse events occurring during the double-blind period were compared between group A and group B.


A total of @ patients received at least one dose of the study drugs .


The rate of sustained virologic response in group A was @ % ( @ % confidence interval , @ to @ ) , which was superior to the historical control rate .


Virologic failure during treatment and relapse after treatment occurred in @ % and @ % , respectively , of the patients in group A.


The response rates in group A were @ % among patients with HCV genotype @a infection and @ % among those with HCV genotype @b infection .


The rate of discontinuation due to adverse events was @ % in each study group .


Nausea , pruritus , insomnia , diarrhea , and asthenia occurred in significantly more patients in group A than in group B ( P < @ for all comparisons ) .


Reductions in the hemoglobin level were all of grade @ or @ ; reductions of grade @ and @ occurred in @ % and @ % , respectively , of the patients in group A , whereas grade @ reductions occurred in @ % of the patients in group B.


In previously untreated patients with HCV genotype @ infection and no cirrhosis , a @-week multitargeted regimen of ABT-@ / r-ombitasvir and dasabuvir with ribavirin was highly effective and was associated with a low rate of treatment discontinuation .


( Funded by AbbVie ; SAPPHIRE-I ClinicalTrials.gov number , NCT@ . )


Cognitive interventions increasingly complement psychopharmacological treatment to enhance symptomatic and functional outcome in schizophrenia .


Metacognitive training ( MCT ) is targeted at cognitive biases involved in the pathogenesis of delusions .


To examine the long-term efficacy of group MCT for schizophrenia in order to explore whether previously established effects were sustained .


A @-center , randomized , controlled , assessor-blind , parallel group trial was conducted .


A total of @ inpatients or outpatients with DSM-IV diagnoses of schizophrenia spectrum disorders were enrolled .


All patients were prescribed antipsychotic medication .


The second follow-up assessment took place @ years later after the intervention phase was terminated .


Group MCT targeting cognitive biases vs neuropsychological training ( COGPACK ) .


Patients received a maximum of @ sessions .


The primary outcome measure was a delusion score derived from the Positive and Negative Syndrome Scale ( PANSS ) .


The PANSS positive syndrome and total scores , the Psychotic Symptom Rating Scales , the jumping to conclusions bias , self-esteem , and quality of life served as secondary outcome measures .


The intention-to-treat analyses demonstrated that patients in the MCT group had significantly greater reductions in the core PANSS delusion score , after @ years compared with the control group ( @partial = @ ; P = @ ) .


Among the secondary outcomes , the intention-to-treat analyses also demonstrated that patients in the MCT group had significantly greater reductions in the PANSS positive syndrome score ( @partial = @ ; P = @ ) and the Psychotic Symptom Rating Scales delusion score ( @partial = @ ; P = @ ) .


Significant group differences at the @-year follow-up were also found on measures of self-esteem and quality of life , which did not distinguish groups at earlier assessment points .


Attention was improved in the neuropsychological training group relative to the MCT group .


The completion rate was @ % after @ years .


Metacognitive training demonstrated sustained effects in the reduction of delusions , which were over and above the effects of antipsychotic medication .


Moreover , there were some unanticipated ( `` sleeper '' ) effects as both self-esteem and quality of life were improved after @ years .


Effects on self-esteem and well-being were found even in the absence of an improvement on the jumping to conclusions bias .


Metabolic syndrome is a complex disorder represented by a set of cardiovascular risk factors .


A healthy lifestyle is strongly related to improve Quality of Life and interfere positively in the control of risk factors presented in this condition .


To evaluate the effect of a program of lifestyle modification on the Framingham General Cardiovascular Risk Profile in subjects diagnosed with metabolic syndrome .


A sub-analysis study of a randomized clinical trial controlled blind that lasted three months .


Participants were randomized into four groups : dietary intervention + placebo ( DIP ) , dietary intervention + supplementation of omega @ ( fish oil @ g/day ) ( DIS@ ) , dietary intervention + placebo + physical activity ( DIPE ) and dietary intervention + physical activity + supplementation of omega @ ( DIS@PE ) .


The general cardiovascular risk profile of each individual was calculated before and after the intervention .


The study included @ subjects .


Evaluating the score between the pre and post intervention yielded a significant value ( p < @ ) .


We obtained a reduction for intermediate risk in @ % of subjects .


After intervention , there was a significant reduction ( p < @ ) on cardiovascular age , this being more significant in groups DIP ( @ % ) and DIPE ( @ % ) .


Proposed interventions produced beneficial effects for reducing cardiovascular risk score .


This study emphasizes the importance of lifestyle modification in the prevention and treatment of cardiovascular diseases .


To explore the efficacy and safety of recombinant tissue plasminogen activator ( rt-PA ) in thrombolytic therapy of vena caval thromboembolism .


Ninety patients diagnosed of vena caval thromboembolism by ultrasound or angiography of inferior vena cava were randomly assigned into @ groups .


rt-PA and parental anticoagulant were given to the patients in the treatment group while those in the control group received only parental anticoagulation .


D-dimer , fibrinogen and fibrinogen degradation product were analyzed after @-week treatment .


All subjects were closely monitored for the occurrence of severe complications .


The changes from baseline in the above laboratory parameters in the treatment group were significantly greater than those of the control group ( P < @ ) .


No severe complications occurred in either group .


rt-PA is both safe and effective for the thrombolytic therapy of vena caval thromboembolism .


Intimate partner violence ( IPV ) is a common , costly societal problem .


Interventions designed to reduce IPV recidivism have had limited success but primary prevention efforts are likely to be more effective in reducing the occurrence of IPV .


The purpose of this study was to examine the impact of a computer-based preventive intervention ( ePREP ) on IPV in a sample of married , community couples .


We employed a randomized clinical trial design comparing ePREP to an active placebo control group .


Using a community sample of @ married couples ( @ % Black , @ % Asian , @ % White , @ % Latino , @ % Mixed/biracial ) who had been married , on average , @ years , we examined the impact ePREP on IPV as measured by self and partner reports of the Revised Conflict Tactics Scale .


We assessed couples at baseline , six-weeks post-baseline , and one-year post-baseline .


We used the Actor Partner Interdependence Model with treatment effects to analyze the obtained dyadic data .


We found that ePREP reduced physical and psychological aggression among married couples ( on average across informants , a @ % reduction in expected counts of physical aggression , and a @ standard deviation reduction in psychological aggression ) and that these gains were maintained at a @-year follow-up assessment .


Interventions that can be delivered widely and at a low-cost will increase the likelihood of reaching those who will benefit most from receiving them .


Implications for implementing flexible interventions and changing our approach to treatment delivery are discussed .


Dexmedetomidine ( D ) can prolong the duration of local anesthetics , but the effect of caudal dexmedetomidine on the potency of levobupivacaine ( L ) for caudal block has not been investigated .


This study was designed to determine the effect of caudal dexmedetomidine on levobupivacaine for caudal block in pediatric patients .


Eighty-nine children scheduled for elective inguinal hernia repair or hydrocele were randomly assigned to one of the three groups : Group L ( caudal levobupivacaine ) , Group LD@ ( levobupivacaine plus @gkg ( -@ ) dexmedetomidine ) , or Group LD@ ( levobupivacaine plus @gkg ( -@ ) dexmedetomidine ) .


The primary endpoint was the minimum local anesthetic concentration ( MLAC ) , which was determined using the Dixon up-and-down method .


The secondary endpoints were the duration of analgesia and sedation .


The MLAC values ( sd ) of caudal levobupivacaine were @ ( @ ) % , @ ( @ ) % , and @ ( @ ) % in Groups L , LD@ , and LD@ , respectively .


The values of EC@ and EC@ ( @ % CI ) of caudal levobupivacaine from logistic regression analysis were @ ( @-@ @ ) % and @ ( @-@ @ ) % , @ ( @-@ @ ) % and @ ( @-@ @ ) % , and @ ( @-@ @ ) % and @ ( @-@ @ ) % in Groups L , LD@ , and LD@ , respectively .


The mean durations of analgesia in the postoperative period were @ , @ , and @min in Groups L , LD@ , and LD@ , respectively ( L vs LD@ or LD@ , P < @ ) .


The mean durations of sedation in both Groups LD@ and LD@ also were significantly prolonged , compared with Group L ( P < @ ) .


Caudal dexmedetomidine reduces the MLAC values of levobupivacaine and improves postoperative analgesia in children without any neurological side effects .


Commercial diving often occurs in low visibility , where divers are reliant on their tactile senses .


This study examined the effect of nitrogen narcosis on tactile memory for shapes as well as the influence of psychological and biographical factors on this relationship .


This crossover study tested @ commercial divers in a dry hyperbaric chamber at @ and @ kPa ( @ and @ atmospheres absolute/atm abs ) .


Divers memorized shapes while blindfolded , using their tactile senses only .


Delayed recall was measured at the surface after each dive .


Psychological and biographical data were also collected .


A significant effect of hyperbaric pressure on tactile memory was demonstrated , and a further effect of sequence of testing found .


Thus , divers ' delayed shape recall deteriorated by @ % after learning material at depth , compared to learning on the surface .


There were also significant but small effects of psychological and biographical markers on tactile memory performance , with lower trait anxiety associated with better recall , and lower education associated with poorer recall .


The findings emphasize the importance of utilizing other forms of recording of events or objects at depth , particularly in conditions of low visibility during deeper diving , to aid memory encoding and subsequent recall at the surface .


Children born prematurely who develop retinopathy of prematurity ( ROP ) often develop myopia , and those who require laser treatment may develop very high myopia , which has considerable clinical consequences .


To report refractive outcomes in preterm infants who developed ROP in zone I or zone II posterior as stage @ + ROP or aggressive posterior ROP ( APROP ) .


All infants received intravitreal bevacizumab or laser therapy in a prospective , stratified , randomized , controlled , masked , multicenter clinical trial , Bevacizumab Eliminates the Angiogenic Threat for ROP ( BEAT-ROP ) .


Children who received intravitreal bevacizumab or laser in the BEAT-ROP clinical trial , with treatment randomized by infant , underwent cycloplegic retinoscopic refraction at a mean age of @ years .


Fifteen centers with both pediatric and vitreoretinal ophthalmologists participating in level @ neonatal intensive care units in academic centers with institutional review board approval were included in the trial .


Of the originally enrolled @ infants ( @ eyes ) in the BEAT-ROP clinical trial , @ infants ( @ eyes ) died ( @ received intravitreal bevacizumab ; @ received laser ) and @ eyes had intraocular surgery ( @ infants bilaterally ) .


Thus , @ eyes ( @ infants bilaterally ) were excluded , leaving @ infants ( @ eyes , including @ eyes that received a successful second treatment for recurrence ) .


Follow-up of the BEAT-ROP cohort .


Spherical equivalent refractive outcomes and their distribution by ROP zone and treatment .


Refractions were available for @ of @ eligible infants ( @ % ) and @ of @ eyes ( @ % ) .


Mean ( SD ) spherical equivalent refractions were as follows : zone I , -@ ( @ ) diopters ( D ) in @ eyes that received intravitreal bevacizumab and -@ ( @ ) D in @ eyes that received laser treatment ( P < @ ) ; and zone II posterior , -@ ( @ ) D in @ eyes that received intravitreal bevacizumab and -@ ( @ ) D in @ eyes that received laser treatment ( P < @ ) .


Very high myopia ( -@ D ) occurred in zone I in @ of @ ( @ % ) eyes that received intravitreal bevacizumab and in @ of @ ( @ % ) eyes that received laser treatment ( P < @ ) .


Very high myopia occurred in zone II posterior in @ of @ ( @ % ) eyes that received intravitreal bevacizumab and in @ of @ ( @ % ) eyes that received laser treatment ( P < @ ) .


More very high myopia was found in eyes that received laser treatment than in eyes that received intravitreal bevacizumab .


This difference is possibly related to anterior segment development that is present with intravitreal bevacizumab but minimal or absent following laser treatment .


Efficacy and safety of sugammadex in reversing neuromuscular block induced by rocuronium or vecuronium were investgated in Japanese patients .


We studied @ Japanese patients undergoing surgery requiring general anesthesia .


Patients were allocated randomly to receive intubation dose of rocuronium or vecuronium .


During surgery , patients received additional dose of rocuronium or vecuronium for maintenance of deep block .


At @-@ PTC , @-@ @ mg .


kg-@ of sugammadex was administered .


The neuromuscular block was monitored with acceleromyography using TOF stimuli .


Sevoflurane was administered to all treatment groups after intubation .


For the rocuronium-induced neuromuscular block , the mean recovery time of the T@/T@ ratio to @ decreased from @ min in the sugammadex @ mg kg-@ group to @ min in the sugammadex @ mg kg-@ group .


For the vecuronium-induced neuromuscular block it decreased from @ min in the sugammadex @ mg .


kg-@ group to @ min in the sugammadex @ mg .


kg-@ group .


No clinical evidence of recurarization or residual curarization was observed .


The efficacy and safety of sugammadex were confirmed in Japanese surgical patients for reversal from deep block .


Few treatments have the potential to reduce the severity of radiation-induced mucositis in head and neck cancer patients .


Some small studies have suggested that organic honey may be a useful preventive treatment .


This investigator-initiated double-blind randomized placebo-controlled trial investigated whether honey reduced the severity of radiation-induced oral mucositis ( ROM ) .


One hundred six head and neck cancer patients from the Vancouver and Sudbury Cancer Centers in Canada were randomized to swish , hold , and swallow either @ ml of irradiated organic manuka honey or a placebo gel , four times a day throughout radiation treatment , plus seven more days .


Severity of oral mucositis according to the Radiation Therapy Oncology Group ( RTOG ) , World Health Organization ( WHO ) , and Oral Mucositis Assessment Scale scales , weight , and subjects ' symptom severity and quality of life were assessed weekly .


Sialometry was performed at baseline and at the last study visit .


One hundred six patients were recruited .


Twenty-four did not attend any mucositis assessments .


One was removed from the study because of off-study consumption of store-bought manuka honey .


The remaining @ patients had at least one mucositis assessment and were included in the analysis .


Sixty-two percent of subjects received concurrent chemotherapy ; @ % were male .


The groups were well-matched , and blinding was excellent .


Dropouts were mostly due to nausea and were similar in both arms , with @ % being able to tolerate the study products for more than @ week .


The dropout rate was @ % in those who received honey and @ % in those who received placebo gel .


The dropout rate in those who had concurrent chemotherapy was @ % and in those who only received radiation was @ % .


There was no statistically significant difference between the honey and placebo arms in any of the outcome indicators .


Those who completed the study in both treatment arms had low rates of RTOG greater than or equal to grade @ mucositis ; @ % in the honey group and @ % in the placebo group .


Despite promising earlier reports , manuka honey was not tolerated well by our patients and , even when used as directed , did not have a significant impact on the severity of ROM .


Indigenous Australian youth ( aged @ to @ ) have up to four times the risk of suicide compared with their non-Indigenous counterparts .


Barriers to help-seeking include shame , feared loss of autonomy and negative attitudes towards healthcare providers .


The use of mobile devices and apps continues to rise amongst young people , thus presenting opportunities to utilize these aids in overcoming help-seeking barriers .


Apps have been shown to assist in several health-related areas , including weight loss and smoking cessation , although no apps have as yet been evaluated for suicide prevention .


Moreover , there is a lack of research that scientifically evaluates suicide prevention interventions within Indigenous communities .


In this study , a recently developed self-help app will be evaluated in a randomized controlled trial .


The intervention is based on acceptance and commitment therapy and mindfulness-based cognitive behavioural therapy .


It is aimed at participants who have suicidal thoughts but who are not actively suicidal .


In total , @ participants will be randomly allocated to the intervention-condition ( N = @ ) or to the wait-list control condition ( N = @ ) .


Questionnaires will be completed at baseline , post-test and @ weeks follow-up .


The primary outcome measure is a reduction in frequency and intensity of suicidal thoughts .


Secondary outcome measures are the reduction of depression , anxiety and impulsivity .


This study is the first to evaluate the effectiveness of a self-help app for suicidal thoughts amongst young Indigenous people .


Several limitations and strengths of the design are discussed .


Few investigations have addressed the safety of oxygen from concentrators for use in anesthesia in association with nitrous oxide .


This study evaluated the percent of oxygen from a concentrator in association with nitrous oxide in a semi-closed rebreathing circuit .


Adult patients undergoing low risk surgery were randomly allocated into two groups , receiving a fresh gas flow of oxygen from concentrators ( O@ ) or of oxygen from concentrators and nitrous oxide ( O@N@O ) .


The fraction of inspired oxygen and the percentage of oxygen from fresh gas flow were measured every @ min .


The ratio of FiO@/oxygen concentration delivered was compared at various time intervals and between the groups .


Thirty patients were studied in each group .


There was no difference in oxygen from concentrators over time for both groups , but there was a significant improvement in the FiO@ ( p < @ ) for O@ group while a significant decline ( p < @ ) for O@N@O .


The FiO@/oxygen ratio varied in both groups , reaching a plateau in the O@ group .


Pulse oximetry did not fall below @ % in either group .


The FiO@ in the mixture of O@ and nitrous oxide fell during the observation period although oxygen saturation was higher than @ % throughout the study .


Concentrators can be considered a stable source of oxygen for use during short anesthetic procedures , either pure or in association with nitrous oxide at @:@ volume .


Conflicting blood pressure-lowering effects of catheter-based renal artery denervation have been reported in patients with resistant hypertension .


We compared the ambulatory blood pressure-lowering efficacy and safety of radiofrequency-based renal denervation added to a standardised stepped-care antihypertensive treatment ( SSAHT ) with the same SSAHT alone in patients with resistant hypertension .


The Renal Denervation for Hypertension ( DENERHTN ) trial was a prospective , open-label randomised controlled trial with blinded endpoint evaluation in patients with resistant hypertension , done in @ French tertiary care centres specialised in hypertension management .


Eligible patients aged @-@ years received indapamide @ mg , ramipril @ mg ( or irbesartan @ mg ) , and amlodipine @ mg daily for @ weeks to confirm treatment resistance by ambulatory blood pressure monitoring before randomisation .


Patients were then randomly assigned ( @:@ ) to receive either renal denervation plus an SSAHT regimen ( renal denervation group ) or the same SSAHT alone ( control group ) .


The randomisation sequence was generated by computer , and stratified by centres .


For SSAHT , after randomisation , spironolactone @ mg per day , bisoprolol @ mg per day , prazosin @ mg per day , and rilmenidine @ mg per day were sequentially added from months two to five in both groups if home blood pressure was more than or equal to @/@ mm Hg .


The primary endpoint was the mean change in daytime systolic blood pressure from baseline to @ months as assessed by ambulatory blood pressure monitoring .


The primary endpoint was analysed blindly .


The safety outcomes were the incidence of acute adverse events of the renal denervation procedure and the change in estimated glomerular filtration rate from baseline to @ months .


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


Between May @ , @ , and Oct @ , @ , @ patients were screened for eligibility , @ of those were randomly assigned to treatment ( @ patients in each group , intention-to-treat population ) and @ analysed because of patients with missing endpoints ( @ in the renal denervation group , @ in the control group , modified intention-to-treat population ) .


The mean change in daytime ambulatory systolic blood pressure at @ months was -@ mm Hg ( @ % CI -@ to -@ ) in the renal denervation group and -@ mm Hg ( -@ to -@ ) in the group receiving SSAHT alone , a baseline-adjusted difference of -@ mm Hg ( -@ to -@ ; p = @ ) .


The number of antihypertensive drugs and drug-adherence at @ months were similar between the two groups .


Three minor renal denervation-related adverse events were noted ( lumbar pain in two patients and mild groin haematoma in one patient ) .


A mild and similar decrease in estimated glomerular filtration rate from baseline to @ months was observed in both groups .


In patients with well defined resistant hypertension , renal denervation plus an SSAHT decreases ambulatory blood pressure more than the same SSAHT alone at @ months .


This additional blood pressure lowering effect may contribute to a reduction in cardiovascular morbidity if maintained in the long term after renal denervation .


Previously published research that examined the effects of high egg consumption in people with type @ diabetes ( T@D ) produced conflicting results leading to recommendations to limit egg intake .


However , people with T@D may benefit from egg consumption because eggs are a nutritious and convenient way of improving protein and micronutrient contents of the diet , which have importance for satiety and weight management .


In this randomized controlled study , we aimed to determine whether a high-egg diet ( @ eggs/d for @ d/wk ) compared with a low-egg diet ( < @ eggs/wk ) affected circulating lipid profiles , in particular high-density lipoprotein ( HDL ) cholesterol , in overweight or obese people with prediabetes or T@D .


A total of @ participants were randomly assigned to one of the @ diets as part of a @-mo weight maintenance study .


Participants attended the clinic monthly and were instructed on the specific types of foods and quantities to be consumed .


There was no significant difference in the change in HDL cholesterol from screening to @ mo between groups ; the mean difference ( @ % CI ) between high - and low-egg groups was +@ mmol/L ( -@ , @ mmol/L ; P = @ ) .


No between-group differences were shown for total cholesterol , low-density lipoprotein cholesterol , triglycerides , or glycemic control .


Both groups were matched for protein intake , but the high-egg group reported less hunger and greater satiety postbreakfast .