Over 52 weeks , nausea , diarrhea , and vomiting were the most common adverse events ; incidences were similar between dulaglutide and metformin .


Dulaglutide improves glycemic control and is well tolerated as monotherapy in patients with early stage type 2 diabetes .


Ischemia monitoring can not always be performed by 12-lead ECG .


Hence , the individual performance of the ECG leads is crucial .


No experimental data on the ECG 's specificity for transient ischemia exist .


In 45 patients a 19-lead ECG was registered during a 1-minute balloon occlusion of a coronary artery ( left anterior descending artery [ LAD ] , right coronary artery [ RCA ] or left circumflex artery [ LCX ] ) .


ST-segment shifts and sensitivity/specificity of the leads were measured .


During LAD occlusion , V3 showed maximal ST-segment elevation ( 0.26 mV [ IQR 0.16-0 .33 mV ] , p = 0.001 ) and sensitivity/specificity ( 88 % and 80 % ) .


During RCA occlusion , III showed maximal ST-elevation ( 0.2 mV [ IQR 0.09-0 .26 mV ] , p = 0.004 ) , aVF had the best sensitivity/specificity ( 85 % and 68 % ) .


During LCX occlusion , V6 showed maximal ST-segment elevation ( 0.04 mV [ IQR 0.02-0 .14 mV ] , p = 0.005 ) , and sensitivity/specificity was ( 31 % / 92 % ) but could be improved ( 63 % / 72 % ) using an optimized cut-off for ischemia .


V3 , aVF and V6 show the best performance to detect transient ischemia .


Subclinical depression is one of the most frequent mental comorbidities in patients with diabetes and is associated with a poorer long-term prognosis .


Since there is a lack of specific intervention concepts for this patient group , a self-management-oriented group program ( DIAMOS [ Diabetes Motivation Strengthening ] ) was newly developed and evaluated in a randomized trial .


DIAMOS is composed of cognitive behavioral interventions aiming at the reduction of diabetes distress .


The active control group ( CG ) received diabetes education .


The primary outcome was depressive symptoms .


Secondary outcomes were diabetes distress , well-being , self-care behavior , diabetes acceptance , diabetes treatment satisfaction , HbA1c , and subclinical inflammation .


Two hundred fourteen participants ( mean age 43.3 13.3 years , female sex 56.5 % , type 2 diabetes 34.1 % , mean diabetes duration 14.2 10.5 years , HbA1c 8.9 1.8 % , BMI 28.7 71 kg/m ( 2 ) ) were randomized .


The 12-month follow-up revealed a significantly stronger reduction of depressive symptoms ( Center for Epidemiologic Studies Depression Scale score ) in the DIAMOS group compared with the CG ( 3.9 [ 95 % CI 0.6-7 .3 ] , P = 0.021 ) .


Of the secondary variables , the Patient Health Questionnaire-9 ( 1.7 [ 95 % CI 0.2-3 .2 ] , P = 0.023 ) , Problem Areas in Diabetes scale ( 8.2 [ 95 % CI 3.1-13 .3 ] , P = 0.002 ) , and Diabetes Distress Scale scores ( 0.3 [ 95 % CI 0.1-0 .5 ] , P = 0.012 ) displayed significant treatment effects .


Moreover , the risk of incident major depression in the DIAMOS group was significantly reduced ( odds ratio 0.63 [ 95 % CI 0.42-0 .96 ] , P = 0.028 ) .


Inflammatory variables were not substantially affected .


DIAMOS is more effective in lowering depressive symptoms and diabetes-related distress in diabetic patients with subclinical depression .


DIAMOS also has a preventive effect with respect to the incidence of major depression .


We compared post-breakfast closed-loop glucose control either matched with a carbohydrate-matching bolus or a weight-dependent bolus .


Twelve adults with type 1 diabetes consumed a 75 g CHO breakfast on two occasions .


In random order , the breakfast was accompanied by a full carbohydrate-matching insulin bolus ( 8.30 U [ 7.50 U-11 .50 U ] ) or a partial weight-dependent insulin bolus ( 0.047 U/kg ; 3.45 U [ 2.95 U-3 .75 U ] ) .


Postprandial glucose was regulated by sensor-responsive insulin and glucagon delivery .


Glucose control after the weight-dependent bolus was safe and feasible ( glucose values returned to pre-prandial levels after 5 h ) .


However , 5-hr incremental area under the curve and percentage of time above 10 mmol/L were lower after the full bolus compared to the partial bolus ( IAUC , 2.1 [ 0.8-4 .2 ] mmol/L/hr vs 8.3 [ 6.5-11 .4 ] mmol/L/hr ; time in hyperglycaemia , 24 % [ 6 % -29 % ] vs 50 % [ 25 % -63 % ] ; P < 0.001 ) .


Post-breakfast closed-loop glucose control without carbohydrate counting , but based on weight-dependent bolus is feasible but a carbohydrate-matching bolus provides better glucose control .


NCT01519102 .


The nephrotoxicity of cyclosporine A ( CsA ) accounts for dysfunction of kidney allografts in the clinic .


Short-term intensified dosing using enteric-coated mycophenolate sodium ( EC-MPS ) may facilitate CsA sparing after kidney transplantation without compromising safety .


In a 12-month , single-centre open-label prospective trial , 180 de novo live-donor kidney transplant recipients at low-immunological risk were randomised to a low-dose cyclosporine group which received a low dose of cyclosporine , short-term intensified EC-MPS dosing ( 2160mg/day to week 6 , 1440mg/day thereafter ) and corticosteroids or a standard-dose cyclosporine group which received a standard dose of cyclosporine , standard EC-MPS dosing ( 1440mg/day ) and corticosteroids .


The primary end-point [ treatment failure including biopsy-proven acute rejection ( BPAR ) , graft loss , death ] , secondary end-point and adverse events were monitored .


The primary end-point ( treatment failure ) occurred in 13.3 % ( 12/90 ) of the low-dose cyclosporine group and 16.7 % ( 15/90 ) of the standard-dose cyclosporine group ( p = 0.53 ) ( difference -3.4 % , 95 % confidence interval -11.7 % to 7.5 % , based on a noninferiority margin of 20 % ) .


BPAR occurred in 11.1 % and 13.3 % of patients in the low-dose cyclosporine group and standard-dose cyclosporine group , respectively ( p = 0.65 ) .


The estimated glomerular filtration rate , as calculated by the Cockcroft-Gault formula , was similar at 12months after transplantation ( low-dose cyclosporine group 6319ml/min/1 .73 m ( 2 ) and standard-dose cyclosporine group 5915ml/min/1 .73 m ( 2 ) ; p = 0.43 ) .


The levels of serum creatinine and occurrence of adverse events between the two groups were not statistically different .


A regimen of early intensified EC-MPS dosing permits low-dose cyclosporine in live-donor kidney transplant patients at low-immunological risk without compromising efficacy at 12months ' follow-up .


This study aimed to examine compensatory changes in nonexercise energy expenditure ( NEEx ) and nonexercise physical activity ( NEPA ) in response to an aerobic exercise training program .


Ninety-two overweight/obese ( body mass index , 25-39 .9 kgm ) sedentary young adults ( 18-30 yr ) completed a 10-month randomized clinical efficacy trial of aerobic exercise 5 dwk at either 400 kcal per session ( n = 37 ) , 600 kcal per session ( n = 37 ) , or control ( n = 18 ) .


Total daily energy expenditure ( TDEE ) and resting metabolic rate ( RMR ) were measured at months 0 and 10 .


NEPA was measured by an accelerometer at months 0 , 3.5 , 7 , and 10 .


NEEx was calculated by the following formula : [ ( total daily energy expenditure 0.9 ) - RMR ] - net EEEx ( EEEx-RMR ) .


Mixed modeling was used to examine differences between groups ( group effect ) , within groups ( time effect ) , and group-time interaction for NEEx and NEPA .


Within the exercise groups , there were no significant effects ( all P > 0.05 ) of group , time , or group-time interaction for NEPA .


In addition , there were no significant within - or between-group differences for change in NEEx .


However , activity counts per minute were significantly higher ( P < 0.001 ) in the 600-kcal-per-session group ( 346 141 mind ) versus controls ( 290 106 mind ) at month 7 and significantly higher ( P < 0.001 ) in both the 600-kcal-per-session ( 345 163 mind ) and 400-kcal-per-session groups ( 317 146 mind ) versus controls ( 277 116 mind ) at 10 months .


A 10-month aerobic exercise training program in previously sedentary , overweight and obese young adults was not associated with compensatory decreases in NEEx or NEPA .


Results suggest that overweight and obese individuals do not become less physically active or spend more time in sedentary pursuits in response to exercise .


In adult patients who are critically ill and mechanically ventilated , daily interruption of sedation ( DSI ) is an effective method of improving sedation management , resulting in a decrease of the duration of mechanical ventilation , the length of stay in the intensive care unit ( ICU ) and the length of stay in the hospital .


It is a safe and effective approach and is common practice in adult ICUs .


For critically ill children it is unknown if DSI is effective and feasible .


The aim of this multicenter randomized controlled trial is to evaluate the safety and efficacy of daily sedation interruption in critically ill children .


Children between 0 and 18 years of age who require mechanical ventilation , with an expected duration of at least 48 h and need for sedative infusion , will be included .


After enrollment patients will be randomly assigned to DSI in combination with protocolized sedation ( intervention group ) or protocolized continuous sedation ( control group ) .


A sedation protocol that contains an algorithm for increasing and weaning of sedatives and analgesics will be used .


The sedative infusion will be restarted if the patient becomes uncomfortable or agitated according to the sedation protocol .


The primary endpoint is the number of ventilator-free days at 28 days .


NTR2030 .


Despite the brevity of the procedure , bilateral myringotomy and tympanostomy tube placement ( BMT ) can result in significant postoperative pain and discomfort .


As the procedure is frequently performed without intravenous access , non-parenteral routes of administration are frequently used for analgesia .


The current study prospectively compares the efficacy of intranasal ( IN ) dexmedetomidine with IN fentanyl for children undergoing BMT .


This prospective , double-blinded , randomized clinical trial included pediatric patients undergoing BMT .


The patients were randomized to receive either IN dexmedetomidine ( 1 g/kg ) or fentanyl ( 2 g/kg ) after the induction of general anesthesia with sevoflurane .


All patients received rectal acetaminophen ( 40 mg/kg ) and the first 50 patients also received premedication with oral midazolam .


Postoperative pain and recovery were assessed using pediatric pain and recovery scales , and any adverse effects were monitored for .


The study cohort included 100 patients who ranged in age from 1 to 7.7 years and in weight from 8.6 to 37.4 kg .


They were divided into 4 groups with 25 patients in each group : ( 1 ) midazolam premedication + IN dexmedetomidine ; ( 2 ) midazolam premedication + IN fentanyl ; ( 3 ) no premedication + IN dexmedetomidine ; and ( 4 ) no premedication + IN fentanyl .


Pain scores were comparable when comparing groups 2 , 3 and 4 , but were higher in group 1 ( midazolam premedication with IN dexmedetomidine ) .


There was no difference in total time in the post-anesthesia care unit ( PACU ) or time from arrival in the PACU until hospital discharge between the 4 groups .


The heart rate ( HR ) was significantly lower in group 3 when compared to the other groups at several different times after arrival to the PACU .


No clinically significant difference was noted in blood pressure .


Following BMT , when no premedication is administered , there was no clinical advantage when comparing IN dexmedetomidine ( 1 g/kg ) to IN fentanyl ( 2 g/kg ) .


The addition of oral midazolam as a premedication worsened the outcome measures particularly for children receiving IN dexmedetomidine .


The US Surgeon General has recommended that peer counseling to support breastfeeding become a core service of the Supplemental Nutrition Program for Women , Infants , and Children ( WIC ) .


As of 2008 , 50 % of WIC clients received services from local WIC agencies that offered peer counseling .


Little is known about the effectiveness of these peer counseling programs .


Randomized controlled trials of peer counseling interventions among low-income women in the United States showed increases in breastfeeding initiation and duration , but it is doubtful that the level of support provided could be scaled up to service WIC participants nationally .


We tested whether a telephone peer counseling program among WIC participants could increase breastfeeding initiation , duration , and exclusivity .


We randomly assigned 1948 WIC clients recruited during pregnancy who intended to breastfeed or were considering breastfeeding to 3 study arms : no peer counseling , 4 telephone contacts , or 8 telephone contacts .


We combined 2 treatment arms because there was no difference in the distribution of peer contacts .


Nonexclusive breastfeeding duration was greater at 3 months postpartum for all women in the treatment group ( adjusted relative risk : 1.22 ; 95 % confidence interval [ CI ] : 1.10-1 .34 ) but greater at 6 months for Spanish-speaking clients only ( adjusted relative risk : 1.29 ; 95 % CI : 1.10-1 .51 ) .


The likelihood of exclusive breastfeeding cessation was less among Spanish-speaking clients ( adjusted odds ratio : 0.78 ; 95 % CI : 0.68-0 .89 ) .


A telephone peer counseling program achieved gains in nonexclusive breastfeeding but modest improvements in exclusive breastfeeding were limited to Spanish - speaking women .


How does the successful cryopreservation of semen affect the odds of post-treatment fatherhood among Hodgkin lymphoma ( HL ) survivors ?


Among 334 survivors who wanted to have children , the availability of cryopreserved semen doubled the odds of post-treatment fatherhood .


Cryopreservation of semen is the easiest , safest and most accessible way to safeguard fertility in male patients facing cancer treatment .


Little is known about what proportion of patients achieve successful semen cryopreservation .


To our knowledge , neither the factors which influence the occurrence of semen cryopreservation nor the rates of fatherhood after semen has been cryopreserved have been analysed before .


This is a cohort study with nested case-control analyses of consecutive Hodgkin survivors treated between 1974 and 2004 in multi-centre randomized controlled trials .


A written questionnaire was developed and sent to 1849 male survivors .


Nine hundred and two survivors provided analysable answers .


The median age at treatment was 31 years .


The median follow-up after cryopreservation was 13 years ( range 5-36 ) .


Three hundred and sixty-three out of 902 men ( 40 % ) cryopreserved semen before the start of potentially gonadotoxic treatment .


The likelihood of semen cryopreservation was influenced by age , treatment period , disease stage , treatment modality and education level .


Seventy eight of 363 men ( 21 % ) used their cryopreserved semen .


Men treated between 1994 and 2004 had significantly lower odds of cryopreserved semen use compared with those treated earlier , whereas alkylating or second-line ( chemo ) therapy significantly increased the odds of use ; no other influencing factors were identified .


We found an adjusted odds ratio of 2.03 ( 95 % confidence interval 1.11-3 .73 , P = 0.02 ) for post-treatment fatherhood if semen cryopreservation was performed .


Forty-eight out of 258 men ( 19 % ) who had children after HL treatment became a father using cryopreserved semen .


Data came from questionnaires and so this study potentially suffers from response bias .


We could not perform an analysis with correction for duration of follow-up or provide an actuarial use rate due to lack of dates of semen utilization .


We do not have detailed information on either the techniques used in cryopreserved semen utilization or the number of cycles needed .


Lance Armstrong Foundation , Dutch Cancer Foundation , Ren Vogels Stichting , no competing interests .


Our hypothesis was that patients treated with hinged external fixators as an adjunct to multiple-ligament reconstruction would have fewer reconstruction failures than patients treated without external fixation .


In this prospective randomized study , patients with a knee dislocation either underwent ligament reconstruction with placement of an external hinged knee brace following surgery ( Group A ) or underwent ligament reconstruction with placement of a hinged external fixator ( Compass Knee Hinge ) for six weeks instead of the brace ( Group B ) .


The patients were followed clinically and were evaluated with physical examination , Lysholm and International Knee Documentation Committee knee scores , visual analog scale pain scores , and status regarding return to work and activities .


One hundred patients with 103 knee dislocations were enrolled .


Seventy-seven patients with seventy-nine dislocations ( thirty-two in Group A and forty-seven in Group B ) , with a minimum follow-up interval of twelve months , were available for evaluation .


The mean duration of follow-up was thirty-nine months ( range , twelve to eighty-six months ) .


Nine patients ( 29 % ) in Group A had failed reconstructions compared with seven ( 15 % ) in Group B ( p = 0.15 ) .


Group-A patients had twenty-two ( 21 % ) of 105 reconstructed individual ligaments fail compared with eleven ( 7 % ) of 157 reconstructed ligaments in Group B.


The difference in ligament failure was significant ( p < 0.001 ; power > 0.8 ) , with more favorable results for the patients managed with the external fixation .


Hinged external fixation as a supplement to reconstruction following knee dislocation was associated with fewer failed ligament reconstructions compared with external bracing .


Patients presenting with highly unstable knee dislocations should be considered for hinged external fixation to supplement initial reconstructive procedures .


To compare dosimetric parameters , seed migration rates , operation times , and acute toxicities of intraoperatively built custom-linked ( IBCL ) seeds with those of loose seeds for prostate brachytherapy .


Participants were 140 patients with low or intermediate prostate cancer prospectively allocated to an IBCL seed group ( n = 74 ) or a loose seed group ( n = 66 ) , using quasirandomization ( allocated by week of the month ) .


All patients underwent prostate brachytherapy using an interactive plan technique .


Computed tomography and plain radiography were performed the next day and 1 month after brachytherapy .


The primary endpoint was detection of a 5 % difference in dose to 90 % of prostate volume on postimplant computed tomography 1 month after treatment .


Seed migration was defined as a seed position > 1 cm from the cluster of other seeds on radiography .


A seed dropped into the seminal vesicle was also defined as a migrated seed .


Dosimetric parameters including the primary endpoint did not differ significantly between groups , but seed migration rate was significantly lower in the IBCL seed group ( 0 % ) than in the loose seed group ( 55 % ; P < .001 ) .


Mean operation time was slightly but significantly longer in the IBCL seed group ( 57 min ) than in the loose seed group ( 50 min ; P < .001 ) .


No significant differences in acute toxicities were seen between groups ( median follow-up , 9 months ) .


This prospective quasirandomized control trial showed no dosimetric differences between IBCL seed and loose seed groups .


However , a strong trend toward decreased postimplant seed migration was shown in the IBCL seed group .


Weight monitoring is an important element of HF self-care , yet the most clinically meaningful way to evaluate weight monitoring adherence is uncertain .


We conducted this study to evaluate the association of ( 1 ) self-reported recall and ( 2 ) daily diary-recorded weight monitoring adherence with heart failure-related ( HF-related ) hospitalization .


We conducted a prospective cohort study among 216 patients within a randomized trial of HF self-care training .


All patients had an initial self-care training session followed by 15 calls ( median ) to reinforce educational material ; patients were also given digital scales , instructed to weigh daily , record weights in a diary , and mail diaries back monthly .


Weight monitoring adherence was assessed with a self-reported recall question administered at 12 months and dichotomized into at least daily versus less frequent weighing .


Diary-recorded weight monitoring was evaluated over 12 months and dichotomized into 80 % and < 80 % adherence .


HF-related hospitalizations were ascertained through patient report and confirmed through record review .


Over 12 months in 216 patients , we identified 50 HF-related hospitalizations .


Patients self-reporting daily or more frequent weight monitoring had an incidence rate ratio of 1.34 ( 95 % CI 0.24-7 .32 ) for HF-related hospitalizations compared to those reporting less frequent weight monitoring .


Patients who completed 80 % of weight diaries had an IRR of 0.37 ( 95 % CI 0.18-0 .75 ) for HF-related hospitalizations compared to patients who completed < 80 % of weight diaries .


Self-reported recall of weight monitoring adherence was not associated with fewer HF hospitalizations .


In contrast , diary-recorded adherence 80 % of days was associated with fewer HF-related hospitalizations .


Incorporating diary-based measures of weight monitoring adherence into HF self-care training programs may help to identify patients at risk for HF-related hospitalizations .


Some smokers may benefit from a therapy that combines different nicotine replacement therapies ( NRT ) or drugs with different mechanisms of action.The aim of this study was to determine the efficacy of the combined therapy of varenicline and nicotine patches versus varenicline monotherapy .


Three hundred forty-one smokers who smoked 20 or more cigarettes per day were recruited from a smoking cessation clinic between February 2012 and June 2013 .


The participants were randomized to receive a varenicline plus nicotine patch of 21 mg every 24 hours ( 170 ) or varenicline plus a placebo patch ( 171 ) .


All of the smokers received a standard 12-week course of varenicline and an 11-week course of either the placebo patch or the active patch after the target quit day .


Both groups received behavioral support .


The primary outcome was continuous abstinence for weeks 2 through 12 confirmed by exhaled levels of carbon monoxide .


Post hoc subgroup analyses were performed to evaluate the treatment effects for a specific endpoint in subgroups of smokers .


The combination of the nicotine patch with varenicline was not associated with higher rates of continuous abstinence at 12 weeks ( 39.1 % versus 31.8 % ; odds ratio ( OR ) 1.24 ; 95 % confidence interval ( CI ) 0.8 to 2.6 ) and 24 weeks ( 32.8 % versus 28.2 % ; OR 1.17 ; 95 % CI 0.4 to 1.9 ) .


When participants were analyzed by subgroups according to cigarette consumption , the abstinence rates among smokers who smoked more than 29 cigarettes per day at 12 weeks ( OR 1.39 ; 95 % CI 1.2 to 2.5 ) and 24 weeks ( OR 1.46 ; 95 % CI 1.2 to 2.8 ) were significantly higher in the combination group .


Other post hoc analyses based on level of dependence and previous quit attempts did not show subgroup differences .


No differences between the groups for the reported adverse events were observed ( 2 value 0.07 ; P 0.79 ) .


The combination of varenicline with the nicotine patch does not improve abstinence rates at 12 and 24 weeks compared with varenicline used as monotherapy when all smokers were analyzed as a whole , independent of consumption level .


This study is registered at clinicaltrial.gov ( NCT01538394 ) .


Metabolic syndrome ( MetS ) and depression have become two prevalent diseases worldwide , whose interaction needs further investigation .


Dietary treatment for weight loss in patients with MetS may improve depressive manifestations , however , the precise interactive pathways remain uncertain .


Therefore , the aim of this study was to examine the effects of a hypocaloric diet designed to reduce MetS features on self-perceived depression and the possible underlying factors .


Sixty subjects ( Age : 50 1 y ; BMI : 36.1 0.6 kg/m ( 2 ) ) with MetS were selected from the RESMENA study ( control and intervention ) after they completed the 6-months hypocaloric treatment and rated for depressive symptoms using the Beck Depression Inventory ( BDI ) .


Anthropometric and biochemical measurements including leptin , C-reactive protein ( CRP ) and insulin levels were evaluated .


Depressive symptoms decreased during the weight loss intervention , with no differences between both dietary groups ( control group -4.2 0.8 vs RESMENA group -3.2 0.6 , P = 0.490 ) .


The number of criteria of the MetS was higher among subjects with more somatic-related depressive symptoms at baseline ( B = 1.032 , P-trend = 0.017 ) .


After six months of dietary treatment , body weight decreased in all subjects ( -8.7 % ; confidence interval ( 95 % CI ) = 7.0-9 .7 ) and also self-perceived depression ( -37.9 % ; 95 % CI = 2.7-4 .9 ) , as well as circulating leptin ( -20.1 % ; 95 % CI = 1.8-6 .8 ) , CRP ( -42.8 % ; 95 % CI = 0.6-3 .0 ) and insulin ( -37.7 % ; 95 % CI = 4.1-7 .2 ) concentrations .


The decrease in BDI was significantly associated with declines in body fat mass ( B = 0.34 , 95 % CI = 0.11-0 .56 ) and also with the decrease in leptin ( B = 0.16 , 95 % CI = 0.04-0 .28 ) and CRP ( B = 0.24 , 95 % CI = 0.01-0 .46 ) concentrations .


The decrease in depressive manifestations after a weight loss intervention was related with adiposity , CRP and leptin in subjects with MetS .


ClinicalTrials.gov : NCT01087086 .


Brain scans are essential to exclude haemorrhage in patients with suspected acute ischaemic stroke before treatment with alteplase .


However , patients with early ischaemic signs could be at increased risk of haemorrhage after alteplase treatment , and little information is available about whether pre-existing structural signs , which are common in older patients , affect response to alteplase .


We aimed to investigate the association between imaging signs on brain CT and outcomes after alteplase .


IST-3 was a multicentre , randomised controlled trial of intravenous alteplase ( 09 mg/kg ) versus control within 6 h of acute ischaemic stroke .


The primary outcome was independence at 6 months ( defined as an Oxford Handicap Scale [ OHS ] score of 0-2 ) .


3035 patients were enrolled to IST-3 and underwent prerandomisation brain CT. .


Experts who were unaware of the random allocation assessed scans for early signs of ischaemia ( tissue hypoattenuation , infarct extent , swelling , and hyperattenuated artery ) and pre-existing signs ( old infarct , leukoaraiosis , and atrophy ) .


In this prespecified analysis , we assessed interactions between these imaging signs , symptomatic intracranial haemorrhage ( a secondary outcome in IST-3 ) and independence at 6 months , and alteplase , adjusting for age , National Institutes of Health Stroke Scale ( NIHSS ) score , and time to randomisation .


This trial is registered at ISRCTN.com , number ISRCTN25765518 .


3017 patients were assessed in this analysis , of whom 1507 were allocated alteplase and 1510 were assigned control .


A reduction in independence was predicted by tissue hypoattenuation ( odds ratio 066 , 95 % CI 055-081 ) , large lesion ( 051 , 038-068 ) , swelling ( 059 , 046-075 ) , hyperattenuated artery ( 059 , 047-075 ) , atrophy ( 074 , 059-094 ) , and leukoaraiosis ( 072 , 059-087 ) .


Symptomatic intracranial haemorrhage was predicted by old infarct ( odds ratio 172 , 95 % CI 118-251 ) , tissue hypoattenuation ( 154 , 104-227 ) , and hyperattenuated artery ( 154 , 103-229 ) .


Some combinations of signs increased the absolute risk of symptomatic intracranial haemorrhage ( eg , both old infarct and hyperattenuated artery , excess with alteplase 138 % , 95 % CI 69-207 ; both signs absent , excess 32 % , 14-51 ) .


However , no imaging findings-individually or combined-modified the effect of alteplase on independence or symptomatic intracranial haemorrhage .


Some early ischaemic and pre-existing signs were associated with reduced independence at 6 months and increased symptomatic intracranial haemorrhage .


Although no interaction was noted between brain imaging signs and effects of alteplase on these outcomes , some combinations of signs increased some absolute risks .


Pre-existing signs should be considered , in addition to early ischaemic signs , during the assessment of patients with acute ischaemic stroke .


UK Medical Research Council , Health Foundation UK , Stroke Association UK , Chest Heart Stroke Scotland , Scottish Funding Council SINAPSE Collaboration , and multiple governmental and philanthropic national funders .


Chronic pain impacts one-third of the U.S. population , and its effects are debilitating for individuals and costly to the medical system .


Although opioids are commonly prescribed to address chronic pain , they confer risk for misuse and addiction in some patients and may not fully restore life function-particularly with regard to psychosocial factors .


Because of the multiplicity of impacts that chronic pain may have on daily functioning , broad-spectrum behavioral interventions are needed .


The purpose of this study was to conduct follow-up analyses from a pilot randomized controlled trial of Mindfulness-Oriented Recovery Enhancement ( MORE ) to assess specific effects of MORE on various biopsychosocial aspects of pain-related impairment .


Chronic pain patients ( N = 115 ; mean age , 4814years ; 68 % female ) were randomly assigned to either eight weeks of MORE or a support group .


Domains of pain-related functional interference were measured with the Brief Pain Inventory at pre - and post-treatment and at a three-month follow-up .


Treatment effects were analyzed with multivariate intention-to-treat models .


MORE participants reported significantly greater reductions in functional interference than support group participants at post-treatment across all domains , including general activity , mood , walking ability , normal work , relationships , sleep , and enjoyment of life .


These effects were largely maintained by the three-month follow-up ; however , general activity level and walking ability were no longer significant , indicating differential long-term effects between physiological and psychological functioning .


Findings demonstrate preliminary efficacy of MORE as a treatment for pain-related functional impairments and suggest that effects may be more pronounced and durable for aspects of psychological function .


To compare efficacy , safety , and tolerability of the preservative-free fixed combination ( FC ) and non-fixed combination ( NFC ) of tafluprost 0.0015 % and timolol 0.5 % in patients with open-angle glaucoma or ocular hypertension .


This 6-month , prospective , randomized , double-masked , active-controlled , parallel group , multicenter phase III study was performed in patients with ocular hypertension and open-angle glaucoma with untreated intraocular pressure ( IOP ) 23 and 36mmHg at baseline .


Four hundred patients washed out from IOP-lowering medication were randomized , 201 received the FC , and 199 received the NFC .


Mean time-wise IOP decreases from baseline ranged from -7.3 to -9.1 mmHg ( 29.6 % -34.6 % ) in the FC and from -7.5 to -9.4 mmHg ( 30.7 % -36.0 % ) in the NFC arm [ per-protocol ( PP ) dataset , P < 0.0001 compared with baseline for both groups ] .


At month 6 , the estimated overall treatment difference ( FC-NFC ) was 0.308 mmHg ( PP dataset , 95 % confidence interval from -0.194 to 0.810 mmHg ) .


An IOP decrease 30 % was achieved in 58.3 % and 66.9 % of the patients in the FC and NFC groups , respectively ( PP dataset ; P = 0.105 ) ; an IOP decrease 35 % was achieved in 36.6 % and 43.1 % of patients in the FC and NFC groups , respectively ( PP dataset ; P = 0.297 ) .


Patients with ocular adverse events were evenly distributed in both groups .


The most common side effect , conjunctival/ocular hyperemia was found in 8 % and 5 % of patients in the FC and NFC arms , respectively .


All measures of IOP reduction for FC of preservative-free tafluprost/timolol were statistically and clinically significant and non-inferior to those of the NFC , throughout the 6-month study period .


Cross-match-compatible platelets are used for the management of thrombocytopenic patients who are refractory to transfusions of randomly selected platelets .


Data supporting the effectiveness of platelets that are compatible according to cross-matching with a modified antigen capture enzyme-linked immunosorbent assay ( MAC-ELISA or MACE ) are limited .


This study aimed to determine the effectiveness of cross-match-compatible platelets in an unselected group of refractory patients .


One hundred ABO compatible single donor platelet transfusions given to 31 refractory patients were studied .


Patients were defined to be refractory if their 24-hour corrected count increment ( CCI ) was < 510 ( 9 ) / L following two consecutive platelet transfusions .


Platelets were cross-matched by MACE and the CCI was determined to monitor the effectiveness of platelet transfusions .


The clinical sensitivity , specificity , positive predictive value and negative predictive value of the MACE-cross-matched platelets for post-transfusion CCI were 88 % , 54.6 % , 39.3 % and 93.2 % , respectively .


The difference between adequate and inadequate post-transfusion 24-hour CCI for MACE cross-matched-compatible vs incompatible single donor platelet transfusions was statistically significant ( p = 0.000 ) .


The 24-hour CCI ( meanSD ) was significantly higher for cross-match-compatible platelets ( 9,250026.6 ) than for incompatible ones ( 6,757.942,656.5 ) ( p < 0.0001 ) .


Most of the incompatible cross-matches ( 73.2 % ) were due to anti-HLA antibodies , alone ( 55.3 % of cases ) or together with anti-platelet glycoprotein antibodies ( 17.9 % ) .


The clinical sensitivity and negative predictive value of platelet cross-matching by MACE were high in this study and such tests may , therefore , be used to select compatible platelets for refractory patients .


A high negative predictive value demonstrates the greater chance of an adequate response with cross-matched-compatible platelets .


Training efforts in disaster education need to provide updated knowledge , skills and expertise to nurses through evidence-based interventions .


The purpose of the study was the development , implementation and evaluation of an educational programme for nurses regarding the provision of health care during disasters .


A randomized controlled trial using Switching Replications design was conducted for the evaluation of the programme .


207 hospital-based nurses were randomly assigned into intervention ( n = 112 ) and original control ( n = 95 ) groups .


Changes between groups and over time were measured by questionnaire and used as the outcome measure to demonstrate effectiveness of the training intervention .


The intervention improved nurses ' knowledge and self-confidence levels while no significant changes were detected in behavioral intentions .


A significant increase in the mean knowledge score was observed in both groups in times 2 and 3 compared to time 1 [ pre-test : 6.43 ( 2.8 ) ; post-test : 16.49 ( 1.7 ) ; follow-up test : 13.5 ( 2.8 ) ] , ( P < 0.002 ) .


Changes in knowledge between intervention and control group were significantly different ( P < 0.001 ) with a large effect size ( eta-squared = 0.8 ) .


The training programme was feasible and effective in improving nurses ' knowledge concerning disaster response .


To examine the influence of the glycemic index ( GI ) of foods consumed after evening exercise on postprandial glycemia , metabolic and inflammatory markers , and nocturnal glycemic control in type 1 diabetes .


On two evenings ( 1700 h ) , 10 male patients ( 27 5 years of age , HbA1c 6.7 0.7 % [ 49.9 8.1 mmol/mol ] ) were administered a 25 % rapid-acting insulin dose with a carbohydrate bolus 60 min before 45 min of treadmill running .


At 60 min postexercise , patients were administered a 50 % rapid-acting insulin dose with one of two isoenergetic meals ( 1.0 g carbohdyrate/kg body mass [ BM ] ) matched for macronutrient content but of either low GI ( LGI ) or high GI ( HGI ) .


At 180 min postmeal , the LGI group ingested an LGI snack and the HGI group an HGI snack ( 0.4 g carbohdyrate/kg BM ) before returning home ( 2300 h ) .


Interval samples were analyzed for blood glucose and lactate ; plasma glucagon , epinephrine , interleukin-6 ( IL-6 ) , and tumor necrosis factor - ( TNF - ) ; and serum insulin , cortisol , nonesterified fatty acid , and - hydroxybutyrate concentrations .


Interstitial glucose was recorded for 20 h postlaboratory attendance through continuous glucose monitoring .


Following the postexercise meal , an HGI snack induced hyperglycemia in all patients ( mean SD glucose 13.5 3.3 mmol/L ) and marked increases in TNF - and IL-6 , whereas relative euglycemia was maintained with an LGI snack ( 7.7 2.5 mmol/L , P < 0.001 ) without inflammatory cytokine elevation .


Both meal types protected all patients from early hypoglycemia .


Overnight glycemia was comparable , with a similar incidence of nocturnal hypoglycemia ( n = 5 for both HGI and LGI ) .


Consuming LGI food with a reduced rapid-acting insulin dose following evening exercise prevents postprandial hyperglycemia and inflammation and provides hypoglycemia protection for 8 h postexercise ; however , the risk of late nocturnal hypoglycemia remains .


The study goal was to determine whether clonidine treatment of neonatal abstinence syndrome ( NAS ) would result in a better neurobehavioral performance compared with morphine .


This pilot study prospectively enrolled infants 35 weeks ' gestational age admitted for treatment of NAS .


After informed consent was obtained , infants were randomized to receive morphine ( 0.4 mg/kg per day ) or clonidine ( 5 g/kg per day ) divided into 8 doses .


A 25 % dose escalation every 24 hours was possible per protocol ( maximum of 1 mg/kg per day for morphine and 12 g/kg per day for clonidine ) .


After control of symptoms , the dose was tapered by 10 % every other day .


Clinical staff monitored infants by using Finnegan scoring .


Masked research staff administered the NICU Network Neurobehavioral Scale ( NNNS ) at 1 week and at 2 to 4 weeks after initiation of treatment and the Bayley Scales III , and Preschool Language Scale IV , at 1-year adjusted age .


Analyses included descriptive statistics , repeated measures analysis of variance , and Wilcoxon tests .


Infants treated with morphine ( n = 15 ) versus clonidine ( n = 16 ) did not differ in birth weight or age at treatment .


Treatment duration was significantly longer for morphine ( median 39 days ) than for clonidine ( median 28 days ; P = .02 ) .


NNNS summary scores improved significantly with clonidine but not with morphine .


On subsequent assessment , those receiving clonidine had lower height of arousal and excitability ( P < .05 ) .


One-year motor , cognitive , and language scores did not differ between groups .


Clonidine may be a favorable alternative to morphine as a single-drug therapy for NAS .


A multicenter randomized trial is warranted .


The study examined the rate of remission in individuals experiencing a first episode of schizophrenia ( FES ) in China and explored predictors of remission in the acute phase of the illness .


Fifty-five FES patients were randomly treated with risperidone , olanzapine , or aripiprazole at therapeutic doses for 8 weeks , and their clinical profiles and cognition were assessed using standardized assessment instruments at entry and the end of the study .


Of the 55 patients , 30 ( 54.5 % ) remitted by the end of the 8-week study .


In univariate analyses , shorter duration of untreated psychosis , higher scores on both the time-based prospective memory ( TBPM ) and event-based prospective memory tasks and the Hopkins Verbal Learning Test-revised , and less severe negative symptoms were significantly associated with remission .


In stepwise multiple logistic regression analyses , only higher scores on the TBPM significantly predicted remission .


Individuals having higher scores reflecting better TBPM at baseline were more likely to achieve remission after 8 weeks of optimized antipsychotic treatment .


TPBM may be useful in helping clinicians identify those FES patients most likely to achieve a favorable treatment response .


Danoprevir is a hepatitis C virus ( HCV ) protease inhibitor with activity against genotypes ( G ) 1/G4 , which is maintained at lower doses by ritonavir-boosting .


We report results of a large , randomized , active-controlled phase IIb study of ritonavir-boosted danoprevir ( danoprevir/r ) plus peginterferon alpha-2a / ribavirin ( P/R ) in treatment-naive patients with HCV G1/4 infection .


Treatment-naive patients with HCV G1/4 infection were randomized to twice-daily danoprevir/r 200/100 mg ( A , n = 92 ) ; 100/100 mg ( B , n = 93 ) ; or 50/100 mg ( C , n = 94 ) plus P/R for 24 weeks ; twice-daily danoprevir/r 100/100 mg ( D , n = 94 ) plus P/R for 12 or 24 weeks ; or P/R alone ( E , n = 44 ) for 48 weeks .


Patients in the response-guided therapy arm ( D ) with an extended rapid virological response ( eRVR2 : HCV RNA < 15 IU/ml during Weeks 2-10 ) stopped all therapy at Week 12 ; non-eRVR2 patients continued all treatment to Week 24 .


The primary efficacy endpoint was sustained the virological response ( SVR24 : HCV RNA < 15 IU/ml after 24 weeks of untreated follow-up ) .


SVR24 rates in Arms A , B , C , D and E were 89.1 % , 78.5 % , 66.0 % , 69.1 % and 36.4 % , respectively , in the overall population ; 83.6 % , 69.6 % , 60.3 % , 59.2 % and 38.5 % in G1a-infected patients , 96.6 % , 93.1 % , 73.1 % , 78.4 % and 28.6 % in G1b-infected patients and 100 % , 87.5 % , 100 % , 100 % and 66.7 % in G4-infected patients .


Danoprevir/r plus P/R was generally well tolerated compared with P/R alone .


There was a higher incidence of serious adverse events in danoprevir-treatment arms , but most were associated with P/R .


The combination of danoprevir/r plus P/R is efficacious in treatment-nave patients with HCV genotype 1 or 4 infection .


There is debate on renal graft stenting during ureteroneocystostomy , patients with ureteral stents may encounter several complications such as encrustation , stent crustation which can lead to loss of kidney , and complications related to stent extraction : pain and UTI increasing related to cystoscopy for stent extraction accompanying excess expenses .


This study designed to reduce complications related to stent extraction .


90 patients prepared for renal transplantation during 1 year randomly classified to groups , study group : patients with attached stent to Foley catheter , control group : patients with conventional technique ( stent separated from Foley ) then in their follow up ; UTI , stent crustation , luts severity compared to each other .


Second week and fourth week UTI reported 25.6 % , 2.3 % in study group versus 34.9 % , 4.7 % in control group ( P.value :0.48 and 0.5 ) .


Urinary leakage was 3.3 % overall , that all of them occurred in separate stent group , 37.5 % vs. 0 % in the linked stent group .


Stent crustation in separate stent was 25 % compared with 0 % in the linked stent .


Low complications rate in linked stent group , despite the lack of significant statistical differences , but indicate the effectiveness and success of the new technique .


Wound edge eversion has been hypothesized to improve aesthetic outcomes after cutaneous wound closure .


Data supporting this assertion are sparse .


We sought to determine if wound eversion , achieved with interrupted subcuticular sutures , improves aesthetic outcome compared with planar closures .


We undertook a prospective , randomized , split-scar intervention in patients who underwent cutaneous surgery .


Half of the wound was randomized to an everted or planar repair ; the other side received the opposite one .


At 3 - and 6-month follow-up , both the patient and 2 blinded observers evaluated the wound using the Patient Observer Self-Assessment Scale ( POSAS ) .


The total observer POSAS score for the everted ( 13.59 , 12.26 ) and planar ( 12.91 , 12.98 ) sides did not differ significantly at 3 or 6 months , respectively .


Similarly , there was not a significant difference in patient assessment between the everted ( 16.23 , 12.84 ) and planar ( 15.07 , 12.79 ) sides at 3 or 6 months , respectively .


Finally , there was no significant difference between the 2 closure methods in terms of scar height or width at follow-up .


This was a single-center trial , which used a validated but still subjective scar assessment instrument .


Wound eversion was not significantly associated with improved overall scar assessments byblinded observers or patient assessment .


Anal incontinence is a frequent complaint that profoundly affects quality of life .


Our aim was to determine whether perineal retraining gives additional benefits to standard medical treatment .


Patients with anal incontinence and a Wexner score > 4 were randomly assigned to standard conservative treatment ( control ) or perineal retraining , including biofeedback , in addition to standard treatments ( biofeedback ) .


Diaries , self-administered questionnaires and satisfaction scores quantified the benefits .


Self-evaluated improvement was the primary outcome measure .


A score 3 ( in an improvement scale from -5 to +5 ) defined success .


Overall , 157 patients were included ; 80 in the control group ( 75 % females , mean age 60.1 13.2 years ) and 77 in the biofeedback group ( 79 % females , mean age 61.9 10.2 years ) .


After a 4-month follow-up , the success rate was significantly higher in the biofeedback group ( 57 % versus 37 % ; p < 0.021 ) .


In the biofeedback group , daily stool frequency , leakage , and faecal urgency significantly decreased , and daily non-urgent perception of stool increased .


Conversely , symptomatic scores and quality of life scales did not significantly differ between groups .


In a multivariate model , the adjusted odds ratio showed that perineal retraining was significantly associated with a higher chance of self-rated improvement ( adjusted Odd Ratio [ 95 % CI ] : 2.34 [ 1.14-4 .80 ] ; p = 0.021 ) .


Perineal retraining offers a moderate but significant benefit for patients suffering from anal incontinence .


Workplace stress in Australia and other western countries has been steadily increasing over the past decade .


It can be observed not only in terms of increased compensation claims but also costs due to absenteeism , loss of productivity at work and reduced psychological and physiological health and well-being .


Given the cost and pervasive effects of stress in the modern workforce , time efficient and cost-effective interventions capable of reducing occupational stress ( or strain ) and burnout are urgently required for the improved well-being of stressed employees .


One intervention gaining scientific traction is supplementation with nutritional interventions , particularly the B group vitamins .


This study was developed to examine the effects of B group vitamins on workplace stress and mood variables with a sample of full-time employed older adults who subjectively report feeling stressed .


The study is a randomized , double-blind , placebo-controlled , parallel-groups clinical trial where 200 ( N = 100/group ) participants will be randomized to receive Blackmores Executive B Stress Formula or placebo daily for a period of 6months .


Participants will be tested at baseline and 6months post-randomization on workplace stress , cognitive , personality and mood measures , cardiovascular ( brachial and aortic systolic and diastolic blood pressures as well as arterial stiffness ) , biochemical ( assays to measure inflammation and safety ) as well as genetic assessments ( to assess stress processing ) and neuroimaging measures ( to investigate in vivo mechanisms of action of B vitamins ) .


In addition to this pre - and post - supplementation testing , participants will also complete a battery of self-report questionnaires online to assess their stress and mood once a month for the duration of the study .


The primary aim of the study is to investigate the effects of B vitamin supplementation on work related stress .


The secondary aims are to explore the mechanisms underpinning any changes in mood or workplace stress due to the B vitamin intervention by examining relationships between cognitive , biological , neuroimaging and cardiovascular variables over 6months .


A subset of 40 participants ( N = 20/group ) will undergo neuroimaging at baseline and at 6months using functional magnetic resonance imaging ( fMRI ) and magnetic resonance spectroscopy ( MRS ) in order to further explore in vivo mechanisms of action of B vitamins .


Australia and New Zealand Clinical Trials Register ( ANZCTR ) : ACTRN12613000294752 .


The purpose of this work was to evaluate the potential of a novel custom-designed rigid gas permeable ( RGP ) contact lens to modify the relative peripheral refractive error in a sample of myopic patients .


Fifty-two right eyes of 52 myopic patients ( mean [ SD ] age , 21 [ 2 ] years ) with spherical refractive errors ranging from -0.75 to -8.00 diopters ( D ) and refractive astigmatism of 1.00 D or less were fitted with a novel experimental RGP ( ExpRGP ) lens designed to create myopic defocus in the peripheral retina .


A standard RGP ( StdRGP ) lens was used as a control in the same eye .


The relative peripheral refractive error was measured without the lens and with each of two lenses ( StdRGP and ExpRGP ) using an open-field autorefractometer from 30 degrees nasal to 30 degrees temporal , in 5-degree steps .


The effectiveness of the lens design was evaluated as the amount of relative peripheral refractive error difference induced by the ExpRGP compared with no lens and with StdRGP conditions at 30 degrees in the nasal and temporal ( averaged ) peripheral visual fields .


Experimental RGP lens induced a significant change in relative peripheral refractive error compared with the no-lens condition ( baseline ) , beyond the 10 degrees of eccentricity to the nasal and temporal side of the visual field ( p < 0.05 ) .


The maximum effect was achieved at 30 degrees .


Wearing the ExpRGP lens , 60 % of the eyes had peripheral myopia exceeding -1.00 D , whereas none of the eyes presented with this feature at baseline .


There was no significant correlation ( r = 0.04 ; p = 0.756 ) between the degree of myopia induced at 30 degrees of eccentricity of the visual field with the ExpRGP lens and the baseline refractive error .


Custom-designed RGP contact lenses can generate a significant degree of relative peripheral myopia in myopic patients regardless of their baseline spherical equivalent refractive error .


Since the introduction of breast-conserving treatment , various radiation doses after lumpectomy have been used .


In a phase 3 randomised controlled trial , we investigated the effect of a radiation boost of 16 Gy on overall survival , local control , and fibrosis for patients with stage I and II breast cancer who underwent breast-conserving treatment compared with patients who received no boost .


Here , we present the 20-year follow-up results .


Patients with microscopically complete excision for invasive disease followed by whole-breast irradiation of 50 Gy in 5 weeks were centrally randomised ( 1:1 ) with a minimisation algorithm to receive 16 Gy boost or no boost , with minimisation for age , menopausal status , presence of extensive ductal carcinoma in situ , clinical tumour size , nodal status , and institution .


Neither patients nor investigators were masked to treatment allocation .


The primary endpoint was overall survival in the intention-to-treat population .


The trial is registered with ClinicalTrials.gov , number NCT02295033 .


Between May 24 , 1989 , and June 25 , 1996 , 2657 patients were randomly assigned to receive no radiation boost and 2661 patients randomly assigned to receive a radiation boost .


Median follow-up was 17.2 years ( IQR 13.0-19 .0 ) .


20-year overall survival was 59.7 % ( 99 % CI 56.3-63 .0 ) in the boost group versus 61.1 % ( 57.6-64 .3 ) in the no boost group , hazard ratio ( HR ) 1.05 ( 99 % CI 0.92-1 .19 , p = 0.323 ) .


Ipsilateral breast tumour recurrence was the first treatment failure for 354 patients ( 13 % ) in the no boost group versus 237 patients ( 9 % ) in the boost group , HR 0.65 ( 99 % CI 0.52-0 .81 , p < 0.0001 ) .


The 20-year cumulative incidence of ipsilatelal breast tumour recurrence was 16.4 % ( 99 % CI 14.1-18 .8 ) in the no boost group versus 12.0 % ( 9.8-14 .4 ) in the boost group .


Mastectomies as first salvage treatment for ipsilateral breast tumour recurrence occurred in 279 ( 79 % ) of 354 patients in the no boost group versus 178 ( 75 % ) of 237 in the boost group .


The cumulative incidence of severe fibrosis at 20 years was 1.8 % ( 99 % CI 1.1-2 .5 ) in the no boost group versus 5.2 % ( 99 % CI 3.9-6 .4 ) in the boost group ( p < 0.0001 ) .


A radiation boost after whole-breast irradiation has no effect on long-term overall survival , but can improve local control , with the largest absolute benefit in young patients , although it increases the risk of moderate to severe fibrosis .


The extra radiation dose can be avoided in most patients older than age 60 years .


Fonds Cancer , Belgium .


To record the fate of transfused platelet doses in the North of England , and thereby assist with demand-planning and help target teaching on appropriate use .


Platelet use has risen recently to the extent that donation practice has changed to meet demand .


Two national comparative audits have shown inappropriate use and the 2010 audit concluded that current U.K. guidelines for platelet usage should be completely implemented at a local level .


It is necessary to know how platelets are used and by whom in order to facilitate guideline concordance .


All hospital trusts in the North East and Cumbria recorded data on all platelet doses transfused in two separate 4-week periods in 2012 .


Data were entered onto an electronic survey tool .


One thousand and five hundred and seventy-four reports were received , documenting 1937 transfused doses -- 96 % of total issues for the study periods .


One thousand and forty-five platelet doses ( 54 % ) were given for haematological indications .


The second commonest indication was cardiac surgery ( 201 doses , 10 % of the total ) followed by non-haematological oncology ( 127 doses , 6.5 % ) , critical care ( 106 doses , 5 % ) and liver disease ( 50 doses , 2.5 % ) .


The commonest haematological indication was acute myeloid leukaemia , 310 doses , ( 16 % of all platelet use ) , followed by stem cell transplantation , 271 doses ( 14 % ) .


Seventy-two percent of platelet doses were given prophylactically , the majority without any planned procedure .


The commonest indication for platelet use , where reinforcement of guidelines will be productive , is prophylaxis in haematological disease .


Use of platelets in cardiac surgery is also worthy of close scrutiny .


The aim of this study was to evaluate the safety and efficacy of thyroidectomy using the Harmonic ACE scalpel ( HS ) or the LigaSure Precise ( LS ) instrument in conventional thyroidectomy .


A prospective , randomized controlled trial was performed .


Between August 2011 and June 2012 , 832 patients who required thyroidectomy for papillary thyroid cancer were randomized into groups treated with either the HS or the LS instrument .


Operative time and surgical morbidities were analyzed .


A total of 320 patients ( HS group , N = 164 ; LS instrument group , N = 156 ) were randomized for analysis according to the intention-to-treat principle .


There were no statistically significant differences in the operative times ( HS group versus LS instrument group : 71.9318.26 versus 75.1520.13 ; P = 0.423 ) , postoperative transient hypoparathyroidism ( 13.4 % versus 14.1 % ; P = 0.858 ) , and permanent recurrent laryngeal nerve injuries between the two groups .


In this study , both hemostatic devices were safe and effective in terms of postoperative results and complications without any differences .


Mortality in people in Africa with HIV infection starting antiretroviral therapy ( ART ) is high , particularly in those with advanced disease .


We assessed the effect of a short period of community support to supplement clinic-based services combined with serum cryptococcal antigen screening .


We did an open-label , randomised controlled trial in six urban clinics in Dar es Salaam , Tanzania , and Lusaka , Zambia .


From February , 2012 , we enrolled eligible individuals with HIV infection ( age 18 years , CD4 count of < 200 cells per L , ART naive ) and randomly assigned them to either the standard clinic-based care supplemented with community support or standard clinic-based care alone , stratified by country and clinic , in permuted block sizes of ten .


Clinic plus community support consisted of screening for serum cryptococcal antigen combined with antifungal therapy for patients testing antigen positive , weekly home visits for the first 4 weeks on ART by lay workers to provide support , and in Tanzania alone , re-screening for tuberculosis at 6-8 weeks after ART initiation .


The primary endpoint was all-cause mortality at 12 months , analysed by intention to treat .


This trial is registered with the International Standard Randomised Controlled Trial Number registry , number ISCRTN 20410413 .


Between Feb 9 , 2012 , and Sept 30 , 2013 , 1001 patients were randomly assigned to clinic plus community support and 998 to standard care .


89 ( 9 % ) of 1001 participants in the clinic plus community support group did not receive their assigned intervention , and 11 ( 1 % ) of 998 participants in the standard care group received a home visit or a cryptococcal antigen screen rather than only standard care .


At 12 months , 25 ( 2 % ) of 1001 participants in the clinic plus community support group and 24 ( 2 % ) of 998 participants in the standard care group had been lost to follow-up , and were censored at their last visit for the primary analysis .


At 12 months , 134 ( 13 % ) of 1001 participants in the clinic plus community support group had died compared with 180 ( 18 % ) of 998 in the standard care group .


Mortality was 28 % ( 95 % CI 10-43 ) lower in the clinic plus community support group than in standard care group ( p = 0004 ) .


Screening and pre-emptive treatment for cryptococcal infection combined with a short initial period of adherence support after initiation of ART could substantially reduce mortality in HIV programmes in Africa .


European and Developing Countries Clinical Trials Partnership .


To compare standard coil embolization versus the use of an antireflux microcatheter ( ARM ) in patients undergoing planning angiography before selective internal radiation therapy ( SIRT ) .


A prospective , single-center trial was performed in which 30 patients were randomly assigned to undergo SIRT with coil embolization or the use of an ARM .


The coil group underwent detachable coil embolization of nontarget vessels , and the ARM group underwent infusion of macroaggregated albumin with use of an ARM system , without coil embolization .


Single-photon emission computed tomography ( CT ) / CT was then performed to assess for nontarget distribution .


The primary endpoint was fluoroscopy time during planning angiography .


Secondary endpoints included deployment time , total procedure time , radiation dose-area product , contrast agent used , and adverse events .


Endpoints were evaluated during planning angiography and SIRT .


Over a 9-month period , 30 consecutive patients were randomized at a 1:1 ratio between coil embolization and ARM groups .


Technical success rates were 100 % in both groups .


Mean fluoroscopy time was significantly reduced in the ARM group versus the coil embolization group ( 1.8 min [ range , 0.4-4 .9 min ] vs 6.0 min [ range , 1.9-15 .7 min ] ; P = .002 ) .


The planning procedure time ( P < .001 ) , deployment time ( P < .001 ) , dose-area product ( P = .04 ) , and amount of contrast agent used ( P < .001 ) were also significantly less in the ARM group than in the coil embolization group .


No nontarget distribution was detected in either group .


There was no difference between groups in dose delivered on the day of SIRT ( P = .71 ) .


There were no major or minor adverse events at 30 days .


The use of an ARM during planning angiography can significantly reduce fluoroscopy time , procedure time , and radiation dose .


Diffuse isolated liver metastases are the dominant mode of tumor progression in a number of cancers and present a major treatment challenge for oncologists .


An experimental treatment , percutaneous hepatic perfusion ( PHP ) , utilizes partial venovenous cardiopulmonary bypass to allow administration of high-dose chemotherapy directly and solely to the liver with filtration of chemotherapeutic agents from the blood prior to its return to the systemic circulation , thereby minimizing toxic systemic effects .


The following case series describes the management of 5 patients with metastatic melanoma undergoing serial PHPs .


A single-center experience from a national multi-center random-assignment trial comparing PHP to best alternative care ( BAC ) in patients with diffuse melanoma liver metastases .


A tertiary care hospital .


Five patients with metastatic melanoma to the liver .


Five patients underwent a total of fifteen PHPs using a venovenous bypass circuit with hemofiltration , receiving hepatic intra-arterial melphalan , 3 mg/kg of ideal body weight , for 30 minutes with a total of 60 minutes of hemofiltration .


Five patients tolerated the procedure well with transient hemodynamic and metabolic changes .


In patients with diffuse isolated liver metastases , PHP is a safe and well-tolerated procedure that can be performed more than once and is associated with marked anti-tumor activity in some patients .


Neonatal circumcision is one of the oldest and most frequently performed surgical procedures on males .


Newborns demonstrate strong endogenous reaction to pain and therefore modalities are being explored for optimum pain relief during circumcision .


Pediatric nurses have a vital role for the use of these modalities and minimising the pain response during the neonatal minor procedures .


The aim of this study was to assess the effectiveness of eutectic mixture of local anaesthetic ( EMLA ) cream compared with oral sucrose and both in alleviating pain in neonatal circumcision .


This study was conducted in the Day Care Surgery Department of Maternity and Children Hospital , Dammam City , KSA .


90 full-term newborn males who underwent circumcision were divided randomly into three groups ( 30 each ) .


Each group was assigned to receive a different type of analgesics such as EMLA cream ( Group A ) , oral sucrose ( Group B ) or combination of EMLA cream and oral sucrose ( Group C ) .


Neonatal pain agitation and sedation scale ( N-PASS ) was used 5 min before , during and 5 min after the circumcision procedure to assess the neonatal response to pain .


N-PASS scores were significantly lower in Group C ( median Group C = 5.2 , Group A = 5.8 , Group B = 8.5 ; P < 0.001 ) .


The endogenous response to pain in terms of escalation of heart rate and reduction in O 2 saturation were minimal among Group C ( P < 0.0001 ) .


Duration of crying was comparable among all the groups .


The combination of sucrose and EMLA cream revealed a higher analgesic effect and minimal adverse response to pain than either EMLA cream or sucrose alone during neonatal circumcision .


Colonoscopy is one of the most reliable methods for the detection of colorectal neoplasms .


However , colonic peristalsis during colonoscopy results in some neoplastic lesions being hidden from view and commonly requires an intravenous or intramuscular injection of antispasmodic agents , which may sometimes causes unexpected adverse reactions .


The aim of this study was to evaluate the efficacy of L-menthol spray as an antiperistaltic agent and its effect on adenoma detection .


This was a prospective , randomized , single-blind placebo-controlled trial .


A total of 226 patients who were scheduled to undergo colonoscopy were randomly assigned to receive either 20mL of 1.6 % L-menthol ( n = 118 ) or placebo ( n = 108 ) .


Both treatments were sprayed locally onto the colonic mucosa via an endoscope .


The adenoma detection rate ( ADR ) and the proportion of patients with no peristalsis were the primary and secondary outcomes , respectively .


The ADR was significantly higher in the L-menthol group than in the placebo group ( 60.2 % vs. 42.6 % ; P = 0.0083 ) .


The proportion of patients with no peristalsis after treatment with L-menthol was significantly higher than in the placebo group ( 71.2 % vs. 30.9 % ; P < 0.0001 ) .


There were no adverse effects in either group .


The results suggest that the suppression of colonic peristalsis by L-menthol sprayed directly onto the colonic mucosa improves the ADR .


ID : UMIN 000007972 .


Limited information is available regarding sedation and motor function following repeat dosing of antihistamines .


This study examined how promethazine and loratadine affect day-time drowsiness , the commencement of voluntary movement , and involuntary movement when administered on consecutive days .


Ten healthy young subjects ( 245years ) were recruited into a double-blind , placebo-controlled , three-way crossover study .


Subjects ingested either promethazine , loratadine or a placebo , and ingested the same drug 24h later .


Measures of drowsiness , simple reaction time ( SRT ) , choice reaction time ( CRT ) , and postural tremor were obtained pre-ingestion , 1h post-ingestion and 2h post-ingestion on each day .


Consecutive daily doses of promethazine and loratadine affected SRT and CRT , respectively , whereby reaction time deficits were less pronounced following the repeat dose .


A reduced tremor response was also observed following consecutive daily dosing of promethazine , in contrast to loratadine which caused an increase in tremor amplitude with the consecutive daily dose .


Reaction time and tremor responses differed following the single dose compared to consecutive doses .


Sufferers of allergic rhinitis often require antihistamine dosing regimens that continue over multiple days .


Future studies will benefit from examining drowsiness and movement responses following single doses as well as consecutive dosing .


Stress-relieving effects of balneotherapy compared to progressive muscle relaxation ( PMR ) and to resting were investigated by measuring subjective relaxation and salivary cortisol .


It was also examined whether participants with a high versus low stress level would have a different relaxation response .


A sample of healthy volunteers was randomized to balneotherapy , PMR , or a resting control group , each intervention lasting for 25 min .


Pre - and post-intervention salivary cortisol samples were collected , and participants rated their status of relaxation on a quantitative scale .


In addition , 3 questionnaires were applied to detect participants ' stress level and bodily complaints .


49 healthy participants were recruited ( 65.3 % female ) .


In a pre-post comparison , salivary cortisol decreased ( F = 23.53 , p < 0.001 ) and subjective relaxation ratings increased ( F = 132.18 , p < 0.001 ) in all 3 groups .


Study participants in the balneotherapy group rated themselves as more relaxed after the intervention as compared to the other groups ( F = 5.22 , p < 0.009 ) .


Participants with a high versus low stress level differed in somatic symptoms and in morning cortisol levels , but showed a similar relaxation response .


Findings suggest that compared to PMR and resting , balneotherapy seems to be more beneficial with regard to subjective relaxation effects and similarly beneficial with regard to a decrease in salivary cortisol .


To characterize visual field ( VF ) loss at the baseline visit and to evaluate VF quality control ( QC ) procedures in the Idiopathic Intracranial Hypertension Treatment Trial ( IIHTT ) .


The Visual Field Reading Center ( VFRC ) evaluated 660 baseline VFs ( 1320 hemifields ) from 165 enrolled patients .


Three readers independently classified each superior and inferior hemifield and identified any abnormalities .


A subset ( 20 % ) of the hemifields was reread to evaluate within - and between-reader agreements .


The QC system addressed test parameters , patient data , and shipment errors .


The majority ( 60 % ) of the baseline hemifields consisted of localized nerve fiber bundle-type VF loss .


Approximately one-third ( 31.5 % ) of all the classifications consisted of partial arcuate defects combined with an enlarged blind spot , making this the most common type of hemifield classification .


Inferior hemifield loss was greater than superior loss for both study and nonstudy eyes .


Reader agreements were > 90 % for both inferior and superior hemifields for two out of three readers .


Test-retest reliability agreement for individual readers was 95 % for both hemifields .


There were few QC errors with only 5.48 error points per 100-point VF .


The most common type of IIHTT baseline hemifield abnormality was a localized nerve fiber bundle-like defect .


Localized inferior hemifield loss was more common than superior hemifield loss .


Quality control and within - and between-reader agreement were excellent for the IIHTT ( ClinicalTrials.gov number , NCT01003639 ) .


Analgesia after caesarean section is important because postpartum women with pain have difficulty in mobility , which undermines breastfeeding .


Intrathecal morphine provides adequate and prolonged analgesia after cesarean .


The aim of this study was to compare the quality of analgesia provided by two doses of intrathecal morphine and its side effects in patients undergoing cesarean section .


The study included 123 pregnant women with gestational age over 38 weeks and scheduled for cesarean section .


The women were randomly allocated into two groups to receive either 50 or 100 g of intrathecal morphine ( Group 50/Group 100 ) .


All patients were intrathecally anesthetized with 12 mg of 0.5 % hyperbaric bupivacaine .


Patients were assessed between the 9 ( th ) and 11 ( th ) hour and the 22 ( nd ) and 24 ( th ) hour after blockade for quality of analgesia , analgesic consumption , side effects , and main cause of discomfort in the first 24 hours after surgery .


There was similarity between groups regarding anthropometric data and obstetric history .


There was no statistical difference in pain intensity between groups .


In both groups , pain was more intense in the first 12 hours after anesthesia ( p < 0.001 ) .


Tramadol hydrochloride consumption and time to first dose were similar in both groups .


Pruritus was the most common side effect , with statistically higher incidence in Group 100 ( p = 0.026 ) .


Intrathecal morphine 50 g provides the same quality of analgesia as 100 g , with a lower incidence of side effects .


Unwanted submental fat ( SMF ) may result in an unattractive chin profile and dissatisfaction with appearance .


An approved and rigorously tested non-surgical method for SMF reduction is lacking .


To evaluate the efficacy and safety of ATX-101 for the pharmacological reduction of unwanted SMF in a phase III randomized , double-blind , placebo-controlled study .


Patients ( n = 360 ) with moderate or severe SMF were randomized to receive ATX-101 1 or 2 mg/cm ( 2 ) or placebo injected into their SMF for up to four treatments ~ 28 days apart , with a 12-week follow-up .


Coprimary efficacy endpoints were the proportions of treatment responders , defined as a 1-point reduction in SMF on the Clinician-Reported Submental Fat Rating Scale ( CR-SMFRS ) , and those satisfied with their appearance in association with their face and chin after treatment on the Subject Self-Rating Scale ( SSRS score 4 ) .


Secondary efficacy endpoints included a 1-point improvement in SMF on the Patient-Reported Submental Fat Rating Scale ( PR-SMFRS ) and changes in the Patient-Reported Submental Fat Impact Scale ( PR-SMFIS ) .


Additional patient-reported outcomes and changes in the Skin Laxity Rating Scale were recorded .


Adverse events ( AEs ) and laboratory test results were monitored .


Compared with placebo , a greater proportion of patients treated with ATX-101 1 and 2 mg/cm ( 2 ) showed a 1-point improvement in CR-SMFRS ( 58.3 % and 62.3 % , respectively , vs. 34.5 % with placebo ; P < 0.001 ) and patient satisfaction ( SSRS score 4 ) with the appearance of their face and chin ( 68.3 % and 64.8 % , respectively , vs. 29.3 % ; P < 0.001 ) .


Patient-reported secondary efficacy endpoints showed significant improvements in SMF severity ( PR-SMFRS ; P = 0.009 for ATX-101 1 mg/cm ( 2 ) , P < 0.001 for ATX-101 2 mg/cm ( 2 ) vs. placebo ) and emotions and perceived self-image ( PR-SMFIS ; P < 0.001 ) .


No overall worsening of skin laxity was observed .


AEs were mostly transient , mild to moderate in intensity and localized to the treatment area .


ATX-101 was effective and well tolerated , and may be an alternative to surgery for patients desiring improvement of their submental profile .


Transnasal endoscopy ( TNE ) with ultrathin endoscopes has been advocated as an attractive alternative , for diagnostic upper endoscopy .


To assess tolerability , acceptability and quality of TNE , in comparison with standard upper endoscopy ( SOGD , standard oesophago-gastro-duodenoscopy ) under local anaesthetic .


We prospectively recruited 157 patients ( 83 females/74 males ) mean age 57years .


The Fujinon EG530N ( 5.9 mm ) and EG530WR ( 9.4 mm ) endoscopes were used .


The endoscopist and all patients completed detailed questionnaires regarding tolerability , acceptance and quality of endoscopy using standard visual analogue scales ( VAS ) .


Oxygen saturation ( SaO2 ) , heart rate ( HR ) and systolic blood pressure ( SBP ) were recorded .


Quality of biopsies was evaluated .


Analysis included 161 procedures ( TNE :79 , SOGD :82 ) with duodenal intubation achieved in all patients .


VAS scores for patient comfort were significantly better in the TNE group ( 7.3 vs. 5.3 respectively , P < 0.001 ) .


Twenty patients with previous experience of standard endoscopy were randomised to TNE and 19 of them ( 95.5 % ) preferred the TNE .


Gagging was significantly less in the TNE group ( 0.12 vs. 3.41 respectively , P < 0.001 ) .


Cardiovascular stress was significantly less in the TNE group irrespective of the degree of gagging or comfort .


TNE biopsies were smaller , but adequate for definitive diagnosis , similarly to standard endoscopy .


Transnasal endoscopy is superior to SOGD in terms of comfort and patient acceptance with significantly less cardiovascular stress .


TNE can routinely be used as alternative to SOGD under local anaesthetic , for diagnosis and should be preferentially offered in cardiorespiratory compromised patients .


To determine whether glutamate-evoked jaw muscle pain is altered by the temperature of the solution injected .


Sixteen healthy volunteers participated and received injections of hot ( 48C ) , neutral ( 36C ) , or cold ( 3C ) solutions ( 0.5 mL ) of glutamate or isotonic saline into the masseter muscle .


Pain intensity was assessed with an electronic visual analog scale ( eVAS ) .


Numeric rating scale ( NRS ) scores of unpleasantness and temperature perception , pain-drawing areas , and pressure pain thresholds ( PPTs ) were also measured .


Participants filled out the McGill Pain Questionnaire ( MPQ ) .


Two-way or three-way repeated measures ANOVA were used for data analyses .


Injection of hot glutamate and cold glutamate solutions significantly increased and decreased , respectively , the peak pain intensity compared with injection of neutral glutamate solution .


The duration of glutamate-evoked pain was significantly longer when hot glutamate was injected than when cold glutamate was injected .


No significant effect of temperature on pain intensity was observed when isotonic saline was injected .


No effect of solution temperature was detected on unpleasantness , heat perception , cold perception , area of pain drawings , or PPTs .


There was a significantly greater use of the `` numb '' term in the MPQ to describe the injection of cold solutions compared to the injection of both neutral and hot solutions .


Glutamate-evoked jaw muscle pain was significantly altered by the temperature of the injection solution .


Although temperature perception in the jaw muscle is poor , pain intensity is increased when the muscle tissue temperature is elevated .


Vascular dysfunction plays a central role in sepsis , and it is characterized by hypotension and hyporesponsiveness to vasoconstrictors .


Nitric oxide is regarded as a central element of sepsis vascular dysfunction .


The high amounts of nitric oxide produced during sepsis are mainly derived from the inducible isoform of nitric oxide synthase 2 .


We have previously shown that nitric oxide synthase 2 levels decrease in later stages of sepsis , whereas levels and activity of soluble guanylate cyclase increase .


Therefore , we studied the putative role of other relevant nitric oxide sources , namely , the neuronal ( nitric oxide synthase 1 ) isoform , in sepsis and its relationship with soluble guanylate cyclase .


We also studied the consequences of nitric oxide synthase 1 blockade in the hyporesponsiveness to vasoconstrictors .


Randomized controlled prospective experimental study .


Academic research laboratory .


Female Wistar rats submitted to cecal ligation and puncture method .


1 ) Six , 12 , and 24 hours after cecal ligation and puncture , vascular reactivity to phenylephrine ( 3 and 30 nmol/kg ) before and after 7-nitroindazole ( 45 mol/kg , s.c. ) or aminoguanidine ( 30 mol/kg , s.c. ) administration was evaluated .


2 ) Protein levels and interaction between nitric oxide synthase 1 and soluble guanylate cyclase were determined .


3 ) Six , 12 , and 24 hours after cecal ligation and puncture , thoracic aorta segments were stimulated with phenylephrine in the presence or absence of 7-nitroindazole and cyclic guanosine monophosphate accumulation was determined .


4 ) After 24 hours of cecal ligation and puncture , norepinephrine was infused ( 10 g/kg/min ) in the presence or absence of 7-nitroindazole or S-methyl-L-thiocitrulline ( 1 mol/kg , IV ) and mean arterial pressure was registered .


1 ) Both nitric oxide synthase 1 and soluble guanylate cyclase are expressed in higher levels in vascular tissues during sepsis ; 2 ) both proteins physically interact and nitric oxide synthase 1 blockade inhibits cyclic guanosine monophosphate production ; 3 ) pharmacological blockade of nitric oxide synthase 1 using 7-nitroindazole or S-methyl-L-thiocitrulline reverts the hyporesponsiveness to phenylephrine and increases the vasoconstrictor effect of norepinephrine and phenylephrine .


Sepsis induces increased expression and physical association of nitric oxide synthase 1/soluble guanylate cyclase and a higher production of cyclic guanosine monophosphate that together may help explain sepsis-induced vascular dysfunction .


In addition , selective inhibition of nitric oxide synthase 1 restores the responsiveness to vasoconstrictors .


Therefore , inhibition of nitric oxide synthase 1 ( and possibly soluble guanylate cyclase ) may represent a valuable alternative to restore the effectiveness of vasopressor agents during late sepsis .


Retrospective cohort study .


To identify risk factors for poor short-term outcomes after vertebral augmentation procedures .


Vertebral compression fractures are the most common fractures of osteoporosis and are frequently treated with vertebroplasty or kyphoplasty .


There is a shortage of information about risk factors for short-term , general health outcomes after vertebral augmentation in the literature .


Patients older than 65 years who underwent vertebroplasty or kyphoplasty in 2011 and 2012 were identified from the American College of Surgeons National Surgical Quality Improvement Program database .


Patient characteristics were tested for association with 30-day adverse events , mortality , and readmission using bivariate and multivariate analyses .


A total of 850 patients met inclusion criteria .


The average age was 78.911.7 years ( meanstandard deviation ) and females made up 70.8 % of the cohort .


Of these patients , 9.5 % had any adverse event ( AAE ) , and 6.6 % had a serious adverse event ( SAE ) .


Death occurred in 1.5 % of patients , and 10.8 % were readmitted within the first 30 postoperative days.On multivariate analysis , AAE and SAE were both significantly associated with American Society of Anesthesiologists class 4 ( AAE : odds ratio [ OR ] = 2.7 , P = 0.013 ; SAE : OR = 2.5 , P = 0.040 ) and inpatient status before procedure ( AAE : OR = 2.7 , P < 0.001 , SAE : OR = 2.4 , P = 0.003 ) .


Increased postoperative mortality rate was associated with American Society of Anesthesiologists class 4 ( OR = 6.4 , P = 0.024 ) and the use of nongeneral anesthesia ( OR = 4.0 , P = 0.022 ) .


Readmission was associated with history of pulmonary disease ( OR = 2.0 , P = 0.005 ) and inpatient status before procedure ( OR = 1.9 , P = 0.005 ) .


Adverse general health outcomes were relatively common , and the factors identified in the earlier text associated with patient outcomes after vertebral augmentation may be useful for preoperative discussions and counseling .


3 .


To study the association between changes in brain magnetic resonance imaging ( MRI ) and clinical outcomes in early MS.


MS patients within 12 months of onset were enrolled and followed up to 3 years .


Clinical measures included Symbol Digit Modalities Test ( SDMT ) , MS Functional Composite ( MSFC ) and low contrast letter acuity ( LCLA ) .


MRI outcomes included brain volume changes measured by SIENA and SIENAX normalized measurements [ brain parenchymal volume ( BPV ) , normal-appearing white and gray matter volume ( NAWMV and GMV ) and T2 lesion volume ( T2LV ) ] .


Mixed model regression measured time trends and associations between imaging and clinical outcome .


Forty-three patients were enrolled within 7.54.9 months of onset .


Baseline T2 lesion volume predicted subsequent changes in Paced Auditory Serial Addition Test ( PASAT ) ( p = 0.004 ) , whereas baseline measures of atrophy including BPV , GMV , and NAWMV predicted longitudinal changes in MSFC ( p = 0.016 , p = 0.040 , p = 0.021 , respectively ) and Timed-25 Foot Walk ( p < 0.05 ) .


Each 1 % decrease in SIENA was associated with 1.14 point decrease in SDMT score ( p = 0.03 ) .


Each 1 % decrease in brain volume SIENA was associated with almost 1.5 letters decrease on LCLA ( p = 0.02 ) .


Measures of lesion volume and overall brain volume were associated with different long-term clinical outcome measures in early MS.


VEGFR-2 has a role in gastric cancer pathogenesis and progression .


We assessed whether ramucirumab , a monoclonal antibody VEGFR-2 antagonist , in combination with paclitaxel would increase overall survival in patients previously treated for advanced gastric cancer compared with placebo plus paclitaxel .


This randomised , placebo-controlled , double-blind , phase 3 trial was done at 170 centres in 27 countries in North and South America , Europe , Asia , and Australia .


Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy ( platinum plus fluoropyrimidine with or without an anthracycline ) were randomly assigned with a centralised interactive voice or web-response system in a 1:1 ratio to receive ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15 , plus paclitaxel 80 mg/m ( 2 ) intravenously on days 1 , 8 , and 15 of a 28-day cycle .


A permuted block randomisation , stratified by geographic region , time to progression on first-line therapy , and disease measurability , was used .


The primary endpoint was overall survival .


Efficacy analysis was by intention to treat , and safety analysis included all patients who received at least one treatment with study drug .


This trial is registered with ClinicalTrials.gov , number NCT01170663 , and has been completed ; patients who are still receiving treatment are in the extension phase .


Between Dec 23 , 2010 , and Sept 23 , 2012 , 665 patients were randomly assigned to treatment-330 to ramucirumab plus paclitaxel and 335 to placebo plus paclitaxel .


Overall survival was significantly longer in the ramucirumab plus paclitaxel group than in the placebo plus paclitaxel group ( median 96 months [ 95 % CI 85-108 ] vs 74 months [ 95 % CI 63-84 ] , hazard ratio 0807 [ 95 % CI 0678-0962 ] ; p = 0017 ) .


Grade 3 or higher adverse events that occurred in more than 5 % of patients in the ramucirumab plus paclitaxel group versus placebo plus paclitaxel included neutropenia ( 133 [ 41 % ] of 327 vs 62 [ 19 % ] of 329 ) , leucopenia ( 57 [ 17 % ] vs 22 [ 7 % ] ) , hypertension ( 46 [ 14 % ] vs eight [ 2 % ] ) , fatigue ( 39 [ 12 % ] vs 18 [ 5 % ] ) , anaemia ( 30 [ 9 % ] vs 34 [ 10 % ] ) , and abdominal pain ( 20 [ 6 % ] vs 11 [ 3 % ] ) .


The incidence of grade 3 or higher febrile neutropenia was low in both groups ( ten [ 3 % ] vs eight [ 2 % ] ) .


The combination of ramucirumab with paclitaxel significantly increases overall survival compared with placebo plus paclitaxel , and could be regarded as a new standard second-line treatment for patients with advanced gastric cancer .


Eli Lilly and Company .


To evaluate the effect of statin treatment on strut coverage after drug-eluting stent ( DES ) implantation .


In this study , 60 patients were randomly assigned to undergo sirolimus-eluting stent ( SES ) or biolimus-eluting stent ( BES ) implantation , after which patients were randomly treated with pitavastatin 2 mg or pravastatin 20 mg for 6 months .


The degree of strut coverage was assessed by 6-month follow-up optical coherence tomography , which was performed in 52 DES-implanted patients .


The percentages of uncovered struts were 19.414.7 % in pitavastatin-treated patients ( n = 25 ) and 19.115.2 % in pravastatin-treated patients ( n = 27 ; p = 0.927 ) .


A lower percentage of uncovered struts was significantly correlated with a lower follow-up low-density lipoprotein ( LDL ) cholesterol level ( r = 0.486 ; p = 0.009 ) and a greater decline of the LDL cholesterol level ( r = -0.456 ; p = 0.015 ) in SES-implanted patients , but not in BES-implanted patients .


In SES-implanted patients , the percentage of uncovered struts was significantly lower among those with LDL cholesterol levels of less than 70 mg/dL after 6 months of follow-up ( p = 0.025 ) , but no significant difference in this variable according to the follow-up LDL cholesterol level was noted among BES-implanted patients ( p = 0.971 ) .


Lower follow-up LDL cholesterol levels , especially those less than 70 mg/dL , might have a protective effect against delayed strut coverage after DES implantation .


This vascular healing effect of lower LDL cholesterol levels could differ according to the DES type .


This study evaluated the efficacy of a cancer geneticsspecific questionnaire in facilitating communication about , awareness of , and management of psychosocial problems , as well as in lowering distress levels .


Individuals referred to genetic counseling for cancer at two family cancer clinics in The Netherlands were randomly assigned to an intervention or a control group .


All participants completed the psychosocial questionnaire before counseling .


In the intervention group , the counselors received the results of this questionnaire before the counseling session .


All sessions were audiotaped for content analysis .


Primary outcomes were the frequency with which psychosocial problems were discussed , the genetic counselors awareness of these problems , and their management .


Secondary outcomes included cancer worries and psychological distress , duration and dynamics of the counseling , and satisfaction .


The frequency with which psychosocial problems were discussed with 246 participating counselees was significantly higher in the intervention group ( n = 127 ) than in the control group ( n = 119 ; P = .004 ) , as was the counselors awareness of psychosocial problems regarding hereditary predisposition ( P < .001 ) , living with cancer ( P = .01 ) , and general emotions ( P < .001 ) .


Counselors initiated more discussion of psychosocial problems in the intervention group ( P < .001 ) , without affecting the length of the counseling session .


No significant differences were found on management ( P = .19 ) .


The intervention group reported significantly lower levels of cancer worries ( p = .005 ) and distress ( p = .02 ) after counseling .


The routine assessment of psychosocial problems by questionnaire facilitates genetic counselors recognition and discussion of their clients psychosocial problems and reduces clients distress levels .


To pilot the feasibility of a prenatal lifestyle intervention to modify physical activity and diet among pregnant overweight and obese Hispanic women , with the aim of reducing risk factors for gestational diabetes mellitus .


Women were randomized either to a lifestyle intervention ( n = 33 , 48.5 % ) , consisting of a culturally and linguistically modified , motivationally targeted , individually tailored 6-month prenatal programme , or to standard care ( n = 35 , 51.5 % ) .


Bilingual and bicultural health educators encouraged women to achieve guidelines for physical activity , decrease saturated fat and increase dietary fibre .


Outcomes included gestational weight gain , infant birth weight and biomarkers associated with insulin resistance .


Patient retention up to delivery was 97 % in both study groups .


The lifestyle intervention attenuated the pregnancy-associated decline in moderate-intensity physical activity , but differences between groups were not significant ( mean se -23.4 16.6 vs -27.0 16.2 metabolic equivalent of task h/week ; P = 0.88 ) .


Vigorous-intensity activity increased during the course of pregnancy in the lifestyle intervention group ( mean se 1.6 0.8 metabolic equivalent of task h/week ) and declined in the standard care group ( -0.8 0.8 metabolic equivalent of task h/week ; P = 0.04 ) .


The lifestyle intervention group also had slightly lower gestational weight gain and infant birth weights compared with the standard care group ; however , these differences were not statistically significant .


There were no statistically significant differences in biomarkers of insulin resistance between groups .


Findings suggest that a motivationally matched lifestyle intervention is feasible and may help attenuate pregnancy-related decreases in vigorous physical activity in a population of overweight and obese Hispanic women .


The intervention protocol can readily be translated into clinical practice in underserved and minority populations .


Chronic ischemia related occult systolic dysfunction of the right ventricle is difficult to detect using traditional echocardiography .


The aim of this study was to verify the diagnostic value of speckle-tracking echocardiography in proximal right coronary artery ( pRCA ) lesion-induced right ventricular ( RV ) occult dysfunction .


One hundred forty-two patients undergoing elective coronary angiography for suspected coronary artery disease were divided into two groups according to involvement of the right coronary artery .


In further analysis , significant stenosis before the acute marginal branch was defined as pRCA involvement and compared with a control group .


Global longitudinal strain and RV free wall longitudinal train ( RVLS-FW ) were measured using speckle-tracking echocardiography .


Other traditional parameters to evaluate RV function were also measured .


Eighty-seven patients in the right coronary artery group ( 61.2 % ) displayed significant decreases in the magnitudes of both global longitudinal strain ( -13.65 3.83 % vs -15.69 4.37 % , P = .04 ) and RVLS-FW ( -16.04 5.4 % vs -21.18 4.6 % , P = .04 ) , independent of other parameters .


Conversely , when focusing on pRCA involvement , only RVLS-FW showed significant attenuation in the group with pRCA involvement ( -14.26 4.32 % vs -19.96 4.8 % , P = .001 ) .


On multivariate analysis , RVLS-FW was still independently lower in the group with pRCA involvement ( odds ratio , 1.07 ; 95 % confidence interval , 1.01-1 .14 ; P = .02 ) .


The results of this study show that RVLS-FW was independently impaired in patients with coronary artery disease with right coronary artery stenosis , especially with involvement of the acute marginal branches .


RV strain can be used to detect occult RV dysfunction in patients with stable coronary artery disease .


Young women attending university are at substantial risk for being sexually assaulted , primarily by male acquaintances , but effective strategies to reduce this risk remain elusive .


We randomly assigned first-year female students at three universities in Canada to the Enhanced Assess , Acknowledge , Act Sexual Assault Resistance program ( resistance group ) or to a session providing access to brochures on sexual assault , as was common university practice ( control group ) .


The resistance program consists of four 3-hour units in which information is provided and skills are taught and practiced , with the goal of being able to assess risk from acquaintances , overcome emotional barriers in acknowledging danger , and engage in effective verbal and physical self-defense .


The primary outcome was completed rape , as measured by the Sexual Experiences Survey-Short Form Victimization , during 1 year of follow-up .


A total of 451 women were assigned to the resistance group and 442 women to the control group .


Of the women assigned to the resistance group , 91 % attended at least three of the four units .


The 1-year risk of completed rape was significantly lower in the resistance group than in the control group ( 5.2 % vs. 9.8 % ; relative risk reduction , 46.3 % [ 95 % confidence interval , 6.8 to 69.1 ] ; P = 0.02 ) .


The 1-year risk of attempted rape was also significantly lower in the resistance group ( 3.4 % vs. 9.3 % , P < 0.001 ) .


A rigorously designed and executed sexual assault resistance program was successful in decreasing the occurrence of rape , attempted rape , and other forms of victimization among first-year university women .


( Funded by the Canadian Institutes of Health Research and the University of Windsor ; SARE ClinicalTrials.gov number , NCT01338428 . )


Lace-up ankle braces reduce the incidence of ankle sprains and have been hypothesized to do so through both mechanical and neuromuscular mechanisms .


To determine the effect of lace-up ankle braces on surface electromyography ( sEMG ) measures during walking in adults with chronic ankle instability ( CAI ) .


Randomized crossover .


Laboratory .


Fifteen adults with CAI .


Surface EMG activity was recorded from the anterior tibialis , peroneus longus , lateral gastrocnemius , rectus femoris , biceps femoris and gluteus medius during treadmill walking with and without lace-up ankle braces .


The dependent variables were sEMG amplitude 100 ms pre - and 200 ms post-initial contact , time of activation relative to initial contact , and percent of activation across the stride cycle .


When compared to no brace , ankle bracing resulted in lower pre-contact amplitude of the peroneus longus ( p = 0.02 ) .


The anterior tibialis , peroneus longus , rectus femoris , and gluteus medius were activated later relative to initial contact ( p < 0.03 ) .


The peroneus longus and rectus femoris were activated for a shorter percentage of the stride cycle ( p < 0.05 ) .


Braces cause a change in neuromuscular activity during walking .


Clinicians should be aware of these changes when prescribing braces , as it may relate to the mechanism in which braces decrease sprains .


Osteoarthritis ( OA ) is a heterogeneous group of conditions with disturbed integrity of articular cartilage and changes in the underlying bone .


The pathogenesis of OA is multifactorial and not just a disease of older people .


Hydroxychloroquine ( HCQ ) is a disease-modifying anti-rheumatic drug ( DMARD ) typically used for the treatment of various rheumatic and dermatologic diseases .


Three studies of HCQ in OA , including one abstract and one letter , are available and use a wide variety of outcome measures in small patient populations .


Despite initial evidence for good efficacy of HCQ , there has been no randomized , double-blind , and placebo-controlled trial in a larger patient group .


In the European League Against Rheumatism ( EULAR ) , evidence-based recommendations for the management of hand OA , HCQ was not included as a therapeutic option because of the current lack of randomized clinical trials .


OA TREAT is an investigator-initiated , multicenter , randomized , double-blind , placebo-controlled trial .


A total of 510 subjects with inflammatory and erosive hand OA , according to the classification criteria of the American College of Rheumatology ( ACR ) , with recent X-ray will be recruited across outpatient sites , hospitals and universities in Germany .


Patients are randomized 1:1 to active treatment ( HCQ 200 to 400 mg per day ) or placebo for 52 weeks .


Both groups receive standard therapy ( non-steroidal anti-inflammatory drugs [ NSAID ] , coxibs ) for OA treatment , taken steadily two weeks before enrollment and continued further afterwards .


If disease activity increases , the dose of NSAID/coxibs can be increased according to the drug recommendation .


The co-primary clinical endpoints are the changes in Australian-Canadian OA Index ( AUSCAN , German version ) dimensions for pain and hand disability at week 52 .


The co-primary radiographic endpoint is the radiographic progression from baseline to week 52 .


A multiple endpoint test and analysis of covariance will be used to compare changes between groups .


All analyses will be conducted on an intention-to-treat basis .