TJD combined with conventional Western medical treatment could quickly improve hemodynamics and tissue oxygen metabolism disorder in patients with septic shock , and its curative effect was superior to that of conventional Western medical treatment alone .


In the Total Body Hypothermia for Neonatal Encephalopathy Trial ( TOBY ) , newborns with asphyxial encephalopathy who received hypothermic therapy had improved neurologic outcomes at 18 months of age , but it is uncertain whether such therapy results in longer-term neurocognitive benefits .


We randomly assigned 325 newborns with asphyxial encephalopathy who were born at a gestational age of 36 weeks or more to receive standard care alone ( control ) or standard care with hypothermia to a rectal temperature of 33 to 34C for 72 hours within 6 hours after birth .


We evaluated the neurocognitive function of these children at 6 to 7 years of age .


The primary outcome of this analysis was the frequency of survival with an IQ score of 85 or higher .


A total of 75 of 145 children ( 52 % ) in the hypothermia group versus 52 of 132 ( 39 % ) in the control group survived with an IQ score of 85 or more ( relative risk , 1.31 ; P = 0.04 ) .


The proportions of children who died were similar in the hypothermia group and the control group ( 29 % and 30 % , respectively ) .


More children in the hypothermia group than in the control group survived without neurologic abnormalities ( 65 of 145 [ 45 % ] vs. 37 of 132 [ 28 % ] ; relative risk , 1.60 ; 95 % confidence interval , 1.15 to 2.22 ) .


Among survivors , children in the hypothermia group , as compared with those in the control group , had significant reductions in the risk of cerebral palsy ( 21 % vs. 36 % , P = 0.03 ) and the risk of moderate or severe disability ( 22 % vs. 37 % , P = 0.03 ) ; they also had significantly better motor-function scores .


There was no significant between-group difference in parental assessments of children 's health status and in results on 10 of 11 psychometric tests .


Moderate hypothermia after perinatal asphyxia resulted in improved neurocognitive outcomes in middle childhood .


( Funded by the United Kingdom Medical Research Council and others ; TOBY ClinicalTrials.gov number , NCT01092637 . )


To evaluate the effectiveness and safety of 0.3 % sodium hyaluronate ( HA ) compared to recombinant bovine basic fibroblast growth factor ( rb-bFGF ) for the treatment of corneal epithelial abrasion caused by mechanical damage in Chinese patients .


Thirty patients were randomly assigned to the HA or rb-bFGF treatment group .


The HA group was treated with 0.3 % HA and 0.5 % levofloxacin , and the rb-bFGF group was treated with topical rb-bFGF and 0.5 % levofloxacin .


The primary endpoint was the clinical effectiveness rates at day 3 .


Secondary endpoints were the dimensions of the wound area and the percentage of wound closure .


After 3 days of treatment , the clinical effectiveness rates of the HA group and the rb-bFGF group were 86.67 % ( 13/15 ) and 93.33 % ( 14/15 ) , respectively .


The dimensions of the wound area were reduced from 9.838.50 to 0.020.06 mm ( 2 ) for the HA group at day 7 , and from 10.589.94 to 0.020.07 mm ( 2 ) for the rb-bFGF group .


At day 3 , the wound closure was almost complete in both groups ; 94.73 % in the HA group compared to 95.77 % in the rb-bFGF group ( P > 0.05 ) .


Topical 0.3 % HA provided a promising treatment for superficial corneal abrasion caused by mechanical damage in a manner similar to rb-bFGF .


To identify the determinants of recurrence following primary pterygium excision combined with conjunctival autograft ( CAG ) and intraoperative use of Mitomycin C ( MMC ) or 5-Fluorouracil ( 5-FU ) .


A randomized controlled clinical trial comparing 5-FU ( 50 mg/ml ) plus CAG versus MMC ( 0.01 % ) plus CAG in preventing recurrence of primary pterygium following excision .


A total of 80 eyes of 80 subjects were studied , with 46 eyes in the 5-FU group and 34 eyes in the MMC group .


The mean age was 50.7 + / - 13.1 years with a male : female ratio of 0.95:1 .


Mean follow up period was 35.2 + / - 29.1 weeks .


The overall recurrence rate was 10 % , with a rate of 8.7 % in the 5-FU group and 11.8 % in the MMC group .


The mean age of the patients who had a recurrence was 38.1 + / - 13.3 years compared to 52.1 + / - 12.4 years in those without a recurrence ( p = 0.003 ) .


The median size of the pterygium in patients who had a recurrence was 3.2 mm , while the median size in patients who did not have a recurrence was 3.0 mm ( p = 0.8 ) .


Five ( 12.8 % ) males had a recurrence compared to three ( 7.3 % ) females ( p = 0.48 ) ; while 10.5 % of fleshy pterygia recurred compared to none ( 0 % ) of the non-fleshy pterygia ( p = 1.00 ) .


Younger age remains a risk factor for recurrence when both CAG and antimetabolites are combined in the treatment of pterygium , while the effect of gender , size and morphology of the pterygium may be diminished by such combination .


The optimal platelet inhibition strategy for ACS patients managed without revascularization is unknown .


We aimed to evaluate efficacy and safety of ticagrelor vs. clopidogrel in the non-ST-elevation acute coronary syndrome ( NSTE-ACS ) subgroup of the PLATO trial , in the total cohort , and in the subgroups managed with and without revascularization within 10 days of randomization .


We performed a retrospective analysis of the primary endpoint of cardiovascular death/myocardial infarction/stroke .


Among 18 624 PLATO patients , 11 080 ( 59 % ) were categorized as NSTE-ACS at randomization .


During the initial 10 days , 74 % had angiography , 46 % PCI , and 5 % CABG .


In NSTE-ACS patients , the primary endpoint was reduced with ticagrelor vs. clopidogrel [ 10.0 vs. 12.3 % ; hazard ratio ( HR ) 0.83 ; 95 % confidence interval ( CI ) = 0.74-0 .93 ] , as was myocardial infarction ( 6.6 vs. 7.7 % ; HR 0.86 ; 95 % CI = 0.74-0 .99 ) , cardiovascular death ( 3.7 vs. 4.9 % ; HR 0.77 ; 95 % CI = 0.64-0 .93 ) , and all-cause death ( 4.3 vs. 5.8 % ; HR 0.76 ; 95 % CI = 0.64-0 .90 ) .


Major bleeding rate was similar between treatment groups ( 13.4 vs. 12.6 % ; HR 1.07 ; 95 % CI = 0.95-1 .19 ) , but ticagrelor was associated with an increase in non-CABG major bleeding ( 4.8 vs. 3.8 % ; HR 1.28 ; 95 % CI = 1.05-1 .56 ) .


Within the first 10 days , 5366 ( 48.4 % ) patients were managed without revascularization .


Regardless of revascularization or not , ticagrelor consistently reduced the primary outcome ( HR 0.86 vs. 0.85 , interaction P = 0.93 ) , and all-cause death ( HR 0.75 vs. 0.73 , interaction P = 0.89 ) with no significant increase in overall major bleeding .


In patients with NSTE-ACS , benefit of ticagrelor over clopidogrel in reducing ischaemic events and total mortality was consistent with the overall PLATO trial , independent of actually performed revascularization during the initial 10 days .


Declining of eradication rates for Helicobacter pylori in Korea may be partly from the increasing prevalence of antibiotic resistance , especially clarithromycin resistance .


To compare the efficacy and the safety of using 10-day standard sequential therapy and levofloxacin-containing sequential therapy as a first-line treatment for Helicobacter pylori eradication in Korea .


A total of 200 patients with proven Helicobacter pylori infection randomly received 10-day standard sequential therapy ( n = 100 ) or levofloxacin-containing sequential therapy ( n = 100 ) .


The standard sequential therapy group received rabeprazole and amoxicillin for 5 days , followed by rabeprazole , clarithromycin , and metronidazole for 5 more days .


The levofloxacin-containing sequential therapy group was treated with rabeprazole and amoxicillin for 5 days , followed by rabeprazole , levofloxacin , and metronidazole for 5 more days .


Intention-to-treat eradication rates were 79.0 % and 78.0 % for groups of standard sequential and levofloxacin-containing sequential therapy , respectively ( P = 0.863 ) .


Per-protocol eradication rates were 84.9 % and 81.3 % , respectively , for these two therapies ( P = 0.498 ) .


There were no significant differences between the groups in regard to the eradication rates and adverse events .


The 10-day levofloxacin-containing sequential regimen and the standard sequential regimen showed the similar eradication rates of Helicobacter pylori in Korea .


We investigated whether individualized positive end-expiratory pressure ( PEEP ) improves oxygenation , ventilation , and lung mechanics during one-lung ventilation compared with standardized PEEP .


Thirty patients undergoing thoracic surgery were randomly allocated to the study or control group .


Both groups received an alveolar recruitment maneuver at the beginning and end of one-lung ventilation .


After the alveolar recruitment maneuver , the control group had their lungs ventilated with a 5 cmH2O PEEP , while the study group had their lungs ventilated with an individualized PEEP level determined by a PEEP decrement trial .


Arterial blood samples , lung mechanics , and volumetric capnography were recorded at multiple timepoints throughout the procedure .


The individualized PEEP values in study group were higher than the standardized PEEP values ( 10 2 vs 5 cmH2O ; P < 0.001 ) .


In both groups , arterial oxygenation decreased when bilateral-lung ventilation was switched to one-lung ventilation and increased after the alveolar recruitment maneuver .


During one-lung ventilation , oxygenation was maintained in the study group but decreased in the control group .


After one-lung ventilation , arterial oxygenation was significantly higher in the study group ( 306 vs 231 mmHg , P = 0.007 ) .


Static compliance decreased in both groups when bilateral-lung ventilation was switched to one-lung ventilation .


Static compliance increased significantly only in the study group ( P < 0.001 ) after the alveolar recruitment maneuver and optimal PEEP adjustment .


The alveolar recruitment maneuver did not decrease cardiac index in any patient .


During one-lung ventilation , the improvements in oxygenation and lung mechanics after an alveolar recruitment maneuver were better preserved by ventilation by using individualized PEEP with a PEEP decrement trial than with a standardized 5 cmH2O of PEEP .


Alzheimer 's disease , a global public health issue , accounts for 60 to 80 % of all dementias .


Alzheimer 's disease primarily causes cognitive impairment and drugs have only modest short-term effects , highlighting a pressing need to develop effective interventions .


Aerobic exercise holds promise for treating cognitive impairment in Alzheimer 's disease through biologically sound mechanisms .


Nonetheless , aerobic exercise studies in Alzheimer 's disease are limited with mixed findings .


This pilot randomized controlled trial will investigate the effects of a 6-month , individualized , moderate-intensity cycling intervention ( 20 to 50 minutes per session , 3 times a week ) on cognition and hippocampal volume in community-dwelling older adults with mild-to-moderate Alzheimer 's disease .


The specific aims are to : 1 ) determine the immediate effect of the cycling intervention on cognition in Alzheimer 's disease ; 2 ) examine if the cycling intervention slows cognitive decline in Alzheimer 's disease from baseline to 12 months ; and 3 ) assess the effect of aerobic exercise on hippocampal volume over 12 months .


Ninety subjects will be randomized on a 2:1 allocation ratio to cycling or attention control ( low-intensity stretching ) and followed for another 6 months .


Allocations will be concealed to all investigators and outcome assessors will be blinded to group assignments and previous data .


Cognition will be measured by the Alzheimer 's disease Assessment Scale-Cognition at baseline before randomization and at 3 , 6 , 9 , and 12 months .


Hippocampal volume will be measured by magnetic resonance imaging at baseline and 6 and 12 months .


The sample size of 90 will give 80 % power to detect a 2.5-point difference in within-group changes in the Alzheimer 's disease Assessment Scale-Cognition at 6 months for the cycling group .


Findings from this study will address the critical gap of exercise efficacy in Alzheimer 's disease and use of magnetic resonance imaging as an outcome measure in clinical trials .


This study will provide a potential treatment that may increase physical function and quality of life and curb the prohibitive costs for the growing dementia population .


Primary registration : ( NCT01954550 ; date of registration : 20 September 2013 ) .


Secondary registration : ( NCT01954550 ; date of registration : 1 October 2013 ) .


To observe the primary prevention role of Wuling Capsule ( WC ) on poststroke depression ( PSD ) patients .


Acute stroke patients were recruited and randomized into 2 groups by stratification , 55 in each group .


All patients received same routine treatment of cardiovascular diseases .


Patients in the experimental group additionally took WC ( 0.33 g each pill ) , 3 pills per day , three times per day ; while those in the control group additionally took placebos , 3 pills per day , three times per day .


Two weeks consisted of one therapeutic course .


The diagnosis of PSD was performed once every other week .


Those in accordance with PSD diagnosis discontinued any drug therapy .


Those not in accordance with PSD diagnosis continued the drug therapy for 1-12 therapeutic course ( s ) ( in total of 6 months ) .


If they were still not in accordance with PSD diagnosis , then they discontinued the drug therapy .


The morbidity of PSD , the average time of depression occurrence , Hamilton depression rating scale ( HAMD ) score , and adverse reactions were observed .


The 1 - , 3 - , and 6-month morbidity of PSD was 8 % , 16 % , and 34 % in the experimental group , while they were 19.6 % , 29.4 % , and 54.9 % in the control group .


The occurrence rate was lower in the experimental group than in the control group .


Besides , there was statistical difference in the 6-month occurrence rate between the two groups ( chi2 = 4.465 , P < 0.05 ) .


The average time of PSD occurrence was longer in the experimental group than in the control group ( 14.96 + / - 8.31 weeks vs. 9.36 + / - 6.06 weeks ; t = 6.762 , P < 0.05 ) .


The HAMD score at the PSD occurrence was 11.96 + / - 2.14 in the experimental group , lower than that of the control group ( 14.57 + / - 4.24 ) , showing statistical difference ( t = 5.641 , P < 0.05 ) .


WC was superior to the placebos in lowering the incidence of PSD , delaying the occurrence time of PSD , attenuating the depression degree of PSD , and had certain preventive effect on the incidence of PSD .


Collective caregiving , performed by caregivers working in pairs ( informal primary and secondary caregivers working together ) , is common in the hospice setting .


Research suggests that caregiving pairs may experience different caregiver outcomes .


However , little is known about how caregiving pairs differ from solo caregivers ( informal primary caregivers ) on outcome measures .


The goal of this study was to determine whether being in a caregiver pair affected caregiver anxiety and depression and how outcomes changed over time .


A mixed model analysis was used .


Hospice caregivers ( 260 solo caregivers and 44 caregivers in 22 pairs ) who participated in a larger , randomized controlled trial completed caregiver measures upon hospice admission and periodically until the death of the patient or hospice decertification .


Measured were caregiver quality of life , social support , anxiety , and depression .


Caregiver pairs had higher anxiety and depression scores than solo caregivers .


Emotional , financial , and physical quality of life were associated with decreased depression , whereas only emotional and financial quality of life were correlated with lower levels of anxiety .


Social support was associated with lower levels of depression and anxiety .


Despite assumptions that social support is positively facilitated vis-a-vis collective caregiving , caregiving pairs may be at higher risk for anxiety and depression .


Future research is needed to address why individuals become anxious and/or depressed when working as part of a caregiving pair .


Delayed antibiotic prescribing is an effective method of reducing the consumption of antibiotics for respiratory tract infections ( RTIs ) .


However , interventions to promote its use remain unexplored .


To measure the effects of a GP educational intervention and a computer delayed-prescribing pop-up reminder on antibiotic-dispensing rates .


The study also aimed to identify factors influencing GPs ' decisions to issue delayed prescriptions and patients ' decisions to fill their prescriptions .


Controlled trial nested within a cluster-randomised controlled trial in urban and rural practices in 11 counties in southern Norway .


Educational intervention and control groups were randomly populated from 81 continuing medical education groups .


Within the intervention arm , 107 of the 156 participating GPs were assigned , based on the electronic patient-record system they used , to having a pop-up reminder installed on their computers .


Data on prescribed and dispensed antibiotics from 1 year before , and 1 year during , the intervention were collected and linked .


Valid data were obtained from 328 GPs ( 75 % ) .


At baseline , 92.1 % of prescriptions were filled at pharmacies .


The effect of the educational intervention was a 1 % reduction in approximated risk ( risk ratio [ RR ] 0.99 , 95 % confidence interval [ CI ] = 0.96 to 1.01 ) of antibiotics being dispensed , while the combined effect of the educational and pop-up reminder intervention was a 4 % reduction in approximated risk ( RR 0.96 , 95 % CI = 0.94 to 0.98 ) .


In the pop-up intervention group , 11.0 % of the prescriptions were issued as delayed prescriptions and 59.2 % of these were filled .


Upper RTI , sinusitis , and otitis gave highest odds for delayed prescribing and lowest odds for dispensing .


Promoting delayed prescribing among GPs results in a small decrease in antibiotic dispensing .


The savings potential is greatest for upper RTI , sinusitis , and otitis .


To study eye movements in a large group of children after the removal of unilateral infantile cataract , and to compare fixation instabilities between treatment groups with or without IOL implantation .


The Infant Aphakia Treatment Study ( IATS ) is a randomized , multicenter clinical trial comparing IOL to contact lens ( CL ) treatment with a unilateral infantile cataract in participants who underwent cataract surgery at 1 to 6 months of age .


At age 4.5 years , eye movements were recorded in 103 participants , using a high-speed video camera while the child performed a fixation task .


The recordings were inspected by masked readers for the presence of fixation instabilities ( nystagmus and saccadic oscillations ) .


Overall , fixation instabilities were observed in 50 ( 60 % ) of 83 children who had evaluable recordings , with no differences between treatment groups ( 27 [ 64 % ] of 42 in the IOL group , 23 [ 56 % ] of 41 in the CL group ; P = 0.51 ) .


Nystagmus was seen in 38 % and saccadic oscillations in 31 % , with no differences between treatment groups ( P > 0.33 ) .


Children without a fixation instability had better visual acuity ( P = 0.04 ) .


Nystagmus and saccadic oscillations are well-known consequences of infantile cataracts , presumably the result of visual deprivation during the critical period of visual development .


After early cataract extraction , successful optical correction may reduce further form deprivation and minimize the incidence of these fixation instabilities .


In this study , no differences in the presence of fixation instabilities were found between the two treatment strategies ( CL or IOL ) for optical correction after cataract removal .


( ClinicalTrials.gov number , NCT00212134 . )


This report presents the analysis of the RTOG 0537 multicenter randomized study that compared acupuncture-like transcutaneous stimulation ( ALTENS ) with pilocarpine ( PC ) for relieving radiation-induced xerostomia .


Eligible patients were randomized to twice-weekly 20-minute ALTENS sessions for 24 sessions during 12weeks or PC ( 5mg 3 times daily for 12weeks ) .


The primary endpoint was the change in the University of Michigan Xerostomia-Related Quality of Life Scale ( XeQOLS ) scores from baseline to 9months from randomization ( MFR ) .


Secondary endpoints included basal and citric acid primed whole salivary production ( WSP ) , ratios of positive responders ( defined as patients with 20 % reduction in overall radiation-induced xerostomia symptom burden ) , and the presence of adverse events based on the Common Terminology Criteria for Adverse Events version 3 .


An intention-to-treat analysis was conducted .


One hundred forty-eight patients were randomized .


Only 96 patients completed the required XeQOLS and were evaluable at 9 MFR ( representing merely 68.6 % statistical power ) .


Seventy-six patients were evaluable at 15 MFR .


The median change in the overall XeQOLS in ALTENS and PC groups at 9 and 15 MFR were -0.53 and -0.27 ( P = .45 ) and -0.6 and -0.47 ( P = .21 ) .


The corresponding percentages of positive responders were 81 % and 72 % ( P = .34 ) and 83 % and 63 % ( P = .04 ) .


Changes in WSP were not significantly different between the groups .


Grade 3 or less adverse events , mostly consisting of grade 1 , developed in 20.8 % of patients in the ALTENS group and in 61.6 % of the PC group .


The observed effect size was smaller than hypothesized , and statistical power was limited because only 96 of the recruited 148 patients were evaluable .


The primary endpoint-the change in radiation-induced xerostomia symptom burden at 9 MFR-was not significantly different between the ALTENS and PC groups .


There was significantly less toxicity in patients receiving ALTENS .


Current interventions for haemorrhoidal disease include traditional haemorrhoidectomy ( TH ) and stapled haemorrhoidopexy ( SH ) surgery .


However , uncertainty remains as to how they compare from a clinical , quality of life ( QoL ) and economic perspective .


The study is therefore designed to determine whether SH is more effective and more cost-effective , compared with TH .


eTHoS ( either Traditional Haemorrhoidectomy or Stapled Haemorrhoidopexy for Haemorrhoidal Disease ) is a pragmatic , multicentre , randomised controlled trial .


Currently , 29 secondary care centres are open to recruitment .


Patients , aged 18 year or older , with circumferential haemorrhoids grade II to IV , are eligible to take part .


The primary clinical and economic outcomes are QoL profile ( area under the curve derived from the EuroQol Group 's 5 Dimension Health Status Questionnaire ( EQ-5D ) at all assessment points ) and incremental cost per quality adjusted life year ( QALY ) based on the responses to the EQ-5D at 24 months .


The secondary outcomes include a comparison of the SF-36 scores , pain and symptoms sub-domains , disease recurrence , complication rates and direct and indirect costs to the National Health Service ( NHS ) .


A sample size of n = 338 per group has been calculated to provide 90 % power to detect a difference in the mean area under the curve ( AUC ) of 0.25 standard deviations derived from EQ-5D score measurements , with a two-sided significance level of 5 % .


Allowing for non-response , 400 participants will be randomised per group .


Randomisation will utilise a minimisation algorithm that incorporates centre , grade of haemorrhoidal disease , baseline EQ-5D score and gender .


Blinding of participants and outcome assessors is not attempted .


This is one of the largest trials of its kind .


In the United Kingdom alone , 29,000 operations for haemorrhoidal disease are done annually .


The trial is therefore designed to give robust evidence on which clinicians and health service managers can base management decisions and , more importantly , patients can make informed choices .


Current Controlled Trials ISRCTN80061723 ( assigned 8 March 2010 ) .


The aim of the study was to assess the impact of the long-term use of the composite probiotics in patients after restorative proctocolectomy .


Forty-three patients ( 20 females and 23 males , aged 21 to 68 years ) after restorative proctocolectomy were included in the study .


After randomization patients were divided into placebo group and treatment group with oral intake of probiotic containing Lactobacillus acidophilus , Lactobacillus delbrueckii subsp .


bulgaricus , and Bifidobacterium bifidus .


Patients were investigated during initial visit and during final visit after 9 months .


All patients were subjected to standard clinical and endoscopic examination with microscopic study of the specimens .


Concentrations of calprotectin and pyruvate kinase isoenzyme M2-PK were determined in all cases .


The average severity of pouchitis and the number of patients with pouchitis significantly decrease after 9 months of the probiotic taking .


The concentrations of calprotectin and pyruvate kinase isoenzyme M2-PK significantly decreased after the therapy .


Nine months of the probiotic treatment ( Lactobacillus acidophilus , Lactobacillus delbrueckii subsp .


bulgaricus , and Bifidobacterium bifidus ) reduced the number of patients with pouchitis , decreased the PDAI score , and also decreased the fecal pyruvate kinase and calprotectin .


The long-term probiotics use is safe and well accepted and can be an effective method of the pouchitis prevention .


To compare the efficacy and safety of two doses of once-weekly dulaglutide , a glucagon-like peptide 1 receptor agonist , to sitagliptin in uncontrolled , metformin-treated patients with type 2 diabetes .


The primary objective was to compare ( for noninferiority and then superiority ) dulaglutide 1.5 mg versus sitagliptin in change from baseline in glycosylated hemoglobin A1c ( HbA1c ) at 52 weeks .


This multicenter , adaptive , double-blind , parallel-arm study randomized patients ( N = 1,098 ; mean baseline age 54 years ; HbA1c 8.1 % [ 65 mmol/mol ] ; weight 86.4 kg ; diabetes duration 7 years ) to dulaglutide 1.5 mg , dulaglutide 0.75 mg , sitagliptin 100 mg , or placebo ( placebo-controlled period up to 26 weeks ) .


The treatment period lasted 104 weeks , with 52-week primary end point data presented .


The mean HbA1c changes to 52 weeks were ( least squares mean SE ) : -1.10 0.06 % ( -12.0 0.7 mmol/mol ) , -0.87 0.06 % ( 9.5 0.7 mmol/mol ) , and -0.39 0.06 % ( 4.3 0.7 mmol/mol ) for dulaglutide 1.5 mg , dulaglutide 0.75 mg , and sitagliptin , respectively .


Both dulaglutide doses were superior to sitagliptin ( P < 0.001 , both comparisons ) .


No events of severe hypoglycemia were reported .


Mean weight changes to 52 weeks were greater with dulaglutide 1.5 mg ( -3.03 0.22 kg ) and dulaglutide 0.75 mg ( -2.60 0.23 kg ) compared with sitagliptin ( -1.53 0.22 kg ) ( P < 0.001 , both comparisons ) .


The most common gastrointestinal treatment-emergent adverse events in dulaglutide 1.5 - and 0.75-mg arms were nausea , diarrhea , and vomiting .


Both dulaglutide doses demonstrated superior glycemic control versus sitagliptin at 52 weeks with an acceptable tolerability and safety profile .


Four previously published randomised clinical trials have shown that tamoxifen can reduce the risk of breast cancer in healthy women at increased risk of breast cancer in the first 10 years of follow-up .


We report the long-term follow-up of the IBIS-I trial , in which the participants and investigators remain largely masked to treatment allocation .


In the IBIS-I randomised controlled trial , premenopausal and postmenopausal women 35-70 years of age deemed to be at an increased risk of developing breast cancer were randomly assigned ( 1:1 ) to receive oral tamoxifen 20 mg daily or matching placebo for 5 years .


Patients were randomly assigned to the two treatment groups by telephone or fax according to a block randomisation schedule ( permuted block sizes of six or ten ) .


Patients and investigators were masked to treatment assignment by use of central randomisation and coded drug supply .


The primary endpoint was the occurrence of breast cancer ( invasive breast cancer and ductal carcinoma in situ ) , analysed by intention to treat .


Cox proportional hazard models were used to assess breast cancer occurrence and mortality .


The trial is closed to recruitment and active treatment is completed , but long-term follow-up is ongoing .


This trial is registered with controlledtrials.com , number ISRCTN91879928 .


Between April 14 , 1992 , and March 30 , 2001 , 7154 eligible women recruited from genetics clinics and breast care clinics in eight countries were enrolled into the IBIS-I trial and were randomly allocated to the two treatment groups : 3579 to tamoxifen and 3575 to placebo .


After a median follow up of 16.0 years ( IQR 14.1-17 .6 ) , 601 breast cancers have been reported ( 251 [ 7.0 % ] in 3579 patients in the tamoxifen group vs 350 [ 9.8 % ] in 3575 women in the placebo group ; hazard ratio [ HR ] 0.71 [ 95 % CI 0.60-0 .83 ] , p < 0.0001 ) .


The risk of developing breast cancer was similar between years 0-10 ( 226 [ 6.3 % ] in 3575 women in the placebo group vs 163 [ 4.6 % ] in 3579 women in the tamoxifen group ; hazard ratio [ HR ] 0.72 [ 95 % CI 0.59-0 .88 ] , p = 0.001 ) and after 10 years ( 124 [ 3.8 % ] in 3295 women vs 88 [ 2.6 % ] in 3343 , respectively ; HR 0.69 [ 0.53-0 .91 ] , p = 0.009 ) .


The greatest reduction in risk was seen in invasive oestrogen receptor-positive breast cancer ( HR 0.66 [ 95 % CI 0.54-0 .81 ] , p < 0.0001 ) and ductal carcinoma in situ ( 0.65 [ 0.43-1 .00 ] , p = 0.05 ) , but no effect was noted for invasive oestrogen receptor-negative breast cancer ( HR 1.05 [ 95 % CI 0.71-1 .57 ] , p = 0.8 ) .


These results show that tamoxifen offers a very long period of protection after treatment cessation , and thus substantially improves the benefit-to-harm ratio of the drug for breast cancer prevention .


Cancer Research UK ( UK ) and the National Health and Medical Research Council ( Australia ) .


To assess whether the combination of early inhaled nitric oxide ( iNO ) therapy and vitamin A supplementation lowers the incidence of bronchopulmonary dysplasia ( BPD ) in premature newborns with respiratory failure .


A total of 793 mechanically ventilated infants ( birth weight 500-1250 g ) were randomized ( after stratification by birth weight ) to receive placebo or iNO ( 5 ppm ) for 21 days or until extubation ( 500-749 , 750-999 , or 1000-1250 g ) .


A total of 398 newborns received iNO , and of these , 118 ( 30 % ) received vitamin A according to their enrollment center .


We compared patients who received iNO + vitamin A with those who received iNO alone .


The primary outcome was a composite of death or BPD at 36 weeks postconceptual age .


BPD was reduced in infants who received iNO + vitamin A for the 750-999 g birth weight group compared with iNO alone ( P = .01 ) .


This group also showed a reduction in the combined outcome of BPD + death compared with iNO alone ( P = .01 ) .


The use of vitamin A did not change the risk for BPD in the placebo group .


Overall , the use of vitamin A was low ( 229 of 793 patients , or 29 % ) .


Combined therapy improved Bayley Scales of Infant Development II Mental and Psychomotor Developmental Index scores at 1 year compared with infants treated solely with iNO for the 500-749 g birth weight group .


In this retrospective analysis of the nonrandomized use of vitamin A , combined iNO + vitamin A therapy in preterm infants with birth weight 750-999 g reduced the incidence of BPD and BPD + death and improved neurocognitive outcomes at 1 year in the 500-749 g birth weight group .


Hypercholesterolemia is a strong risk factor in cardiovascular disease .


Oat ( Avena sativa L. ) beta-glucan , the soluble fiber in oat , has been known to reduce blood cholesterol levels considerably .


However , the effect of oat soluble fiber in the Thai population is unknown .


To determine the effect of oat consumption on serum lipid profiles in Thai hypercholesterolemic adults .


The present study was a randomized , crossover design .


Twenty-four hypercholesterolemic adults , male and female aged 30-60 years , were randomly assigned into two groups of twelve each .


Group 1 consumed 70 g ( 3 g beta-glucan ) of oatmeal daily through the first 4-week intervention , and then switched to 70 g rice porridge ( control product ) daily for the next 4-week intervention .


Group 2 consumed rice porridge first and then oatmeal .


Before and after each intervention period , lipid profiles including total cholesterol ( TC ) , triglycerides ( TG ) , high density lipoprotein cholesterol ( HDL-C ) , and low density lipoprotein cholesterol ( LDL-C ) of all subjects were measured .


Following daily oat consumption , total cholesterol and LDL-cholesterol levels were significantly lower than baseline levels and lower than the levels observed with rice consumption .


Oat consumption reduced total cholesterol by 5 % and LDL-cholesterol by 10 % from baseline levels .


In addition , mean and percent changes were significantly different from the levels after consuming rice porridge ( p < 0.05 ) .


Oatmeal reduced serum total cholesterol and LDL-cholesterol levels in hypercholesterolemic Thai adults .


Hence , oat consumption is a reasonable recommendation for Thai individuals with hyperlipidemia .


Chest pain is the second most common reason patients visit emergency departments ( EDs ) and often results in very low-risk patients being admitted for prolonged observation and advanced cardiac testing .


Shared decision-making , including educating patients regarding their 45-day risk for acute coronary syndrome ( ACS ) and management options , might safely decrease healthcare utilization .


This is a protocol for a multicenter practical patient-level randomized trial to compare an intervention group receiving a decision aid , Chest Pain Choice ( CPC ) , to a control group receiving usual care .


Adults presenting to five geographically and ethnically diverse EDs who are being considered for admission for observation and advanced cardiac testing will be eligible for enrollment .


We will measure the effect of CPC on ( 1 ) patient knowledge regarding their 45-day risk for ACS and the available management options ( primary outcome ) ; ( 2 ) patient engagement in the decision-making process ; ( 3 ) the degree of conflict patients experience related to feeling uninformed ( decisional conflict ) ; ( 4 ) patient and clinician satisfaction with the decision made ; ( 5 ) the rate of major adverse cardiac events at 30days ; ( 6 ) the proportion of patients admitted for advanced cardiac testing ; and ( 7 ) healthcare utilization .


To assess these outcomes , we will administer patient and clinician surveys immediately after each clinical encounter , obtain video recordings of the patient-clinician discussion , administer a patient healthcare utilization diary , analyze hospital billing records , review the electronic medical record , and conduct telephone follow-up .


This multicenter trial will robustly assess the effectiveness of a decision aid on patient-centered outcomes , safety , and healthcare utilization in low-risk chest pain patients from a variety of geographically and ethnically diverse EDs .


NCT01969240 .


To evaluate the efficacy of a combined neurolytic block of the celiac and superior hypogastric plexuses for incapacitating upper abdominal cancer pain .


Fifty-two patients with advanced upper abdominal malignancies and incapacitating pain were equally randomized to receive a combined neurolytic block of the celiac and superior hypogastric plexuses ( combined group ) or a neurolytic celiac plexus block alone ( NCPB group ) using a 90 % ethanol trans-intervertebral disk approach under CT guidance .


Visual analogue scores ( VAS ) , morphine consumption , and quality of life ( QoL ) were assessed before the procedure and 24 hrs , 1 week , 1 month , and 3 months after the procedure .


The complications and side effects were also recorded .


The amount of ethanol used was 30 5 ml in the combined group and 21 3 ml in the NCPB group .


VAS scores and morphine consumption decreased significantly pre - compared to post-procedure in both groups ( p < 0.05 ) .


QoL significantly improved 24 hrs , 1 week , and 1 month after the procedure compared with each group pre-procedure ( p < 0.05 ) , but not after 3 months ( p > 0.05 ) .


The combined group had significantly lower VAS and morphine consumption than the NCPB group ( p < 0.05 ) .


QoL scores were significantly higher in the combined group 24 hrs , 1 week , and 1 month post-procedure than the NCPB group ( p < 0.05 ) , but not after 3 months ( p > 0.05 ) .


A combined neurolytic block of the celiac and superior hypogastric plexuses is more effective than neurolytic celiac plexus block alone in pain relief for patients with advanced upper abdominal cancer .


To assess the effectiveness of task-oriented approach in treating patients with spastic dysarthria .


A randomized control trial was undertaken in 44 inpatients diagnosed with spastic dysarthria at the Department of Rehabilitation Medicine in West China Hospital .


All of the participants received basic medical therapy , occupational therapy , physical therapy , and an articulation approach for speech therapy by a professional speech therapist over a one month period .


A task-oriented approach was added to the speech therapy regime of the test group of participants by another professional speech therapist over the same period of time .


The outcomes of speech therapy were measured by the Frenchay dysarthria assessment ( FDA ) .


Significant improvements were found in the test group in relation to 15 FDA items , such as dribbling , lips spread , and palate maintenance ( P < 0.05 ) .


The performance of the participants in the test group on the rest of FDA items also demonstrated an improvement trend compared with that of the controls ( P > 0.05 ) except for the three items in relation to cough , lips at rest and jaw in speech .


Task-oriented approach for speech therapy is effective in treating patients with spastic dysarthria .


A task-oriented approach in combination with an articulation approach can produce better patient outcomes compared with the articulation approach alone .


Further studies are warranted .


This report is the second analysis of a prospective randomized trial to investigate the impact of ( 18 ) F-fluorodeoxyglucose positron emission tomography ( FDG-PET ) on cervical cancer patients with enlarged pelvic lymph nodes identified by magnetic resonance imaging .


Patients with newly diagnosed cervical cancer with enlarged pelvic lymph nodes but free of enlarged para-aortic lymph nodes ( PALN ) were eligible .


Patients were randomized to receive either pretreatment FDG-PET ( PET arm ) or not ( control arm ) .


The whole pelvis was the standard irradiation field for all patients except those with FDG-avid extrapelvic findings .


In all , 129 patients were enrolled .


Pretreatment PET detected extrapelvic metastases in 7 patients .


No new patient experienced treatment failure during the additional 4-year follow-up period .


There were no significant differences between the PET arm and the control arm regarding overall survival , disease-free survival , and freedom from extrapelvic metastasis .


In the control arm , 8 of 10 patients with PALN relapse had limited extrapelvic nodal failures ; their 5-year disease-specific survival was 34.3 % .


By contrast , only 1 of 5 patients with PALN relapse in the PET arm experienced such limited failures ; their 5-year survival rate was 0 % .


Although the pretreatment detection of PALN did not translate into survival benefit , it indeed decreased the need for extended-field concurrent chemoradiation therapy .


To demonstrate the bioequivalence between the test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablet and evaluate the effect of ethnicity on pharmacokinetics properties of losartan , losartan carboxylic acid and hydrochlorothiazide on healthy Asian Indian and Japanese volunteers .


Randomized , open-label , crossover , bioavailability studies were conducted separately in healthy Asian Indian and Japanese volunteers .


One tablet either of test or of reference product was administered after 10 hours of overnight fasting .


After dosing , serial blood samples were collected for a period of 48 hours for both the studies .


Plasma samples were analyzed for losartan , losartan carboxylic acid and hydrochlorothiazide by a validated liquid chromatographic and mass spectrometric method ( LC-MS/MS ) .


The pharmacokinetic parameters AUC0-t , AUC0 - , Cmax , tmax , and other pharmacokinetics parameters were determined from plasma concentration-time profiles for both test and reference formulations of losartan/hydrochlorothiazide 50 + 12.5 mg tablets .


Statistical evaluations were done to evaluate bioequivalence between generic test formulation ( EPR0001 ) and Japanese reference product ( Preminent ) .


Losartan , losartan carboxylic acid and hydrochlorothiazide were well tolerated by subjects in all periods of each study under fasted conditions .


No serious adverse events were observed .


The ratios of least square means for AUC0-t and Cmax and the affiliated 90 % confidence intervals were within acceptance range recommended by PMDA .


Marginal differences were observed in pharmacokinetic values of Asian Indian and Japanese volunteers .


The results of these bioavailability studies indicate that the test formulation of losartan/hydrochlorothiazide 50 + 12.5 mg ( EPR0001 ) tablets is bioequivalent to marketed Preminent reference formulation in Asian Indian and Japanese volunteers , when administered under fasting conditions .


Both test and reference formulations were well tolerated as a single oral dose when administered to healthy adult subjects under fasted conditions .


Although Asian Indian and Japanese volunteers are ethnically different , results of these studies indicate that pharmacokinetic parameters of Asian Indian and Japanese volunteers are comparable to each other in terms of bioavailability of losartan , losartan carboxylic acid and hydrochlorothiazide .


Similar least square means ratios were obtained in Asian Indian and Japanese volunteers demonstrating that a bioequivalence study conducted on Japanese volunteers seems to be substituted by Asian Indian volunteers ' studies .


Suboptimal vitamin D status is highly prevalent in Northern communities , particularly in those patients with chronic diseases such as diabetes and chronic renal disease .


Emerging literature suggests that adherence to daily vitamin D supplementation may be an important factor influencing vitamin D status and overall bone health , but compliance with therapies for bone health is a major challenge .


It is unknown what level of vitamin D supplementation will ameliorate or improve suboptimal vitamin D status in patients with diabetic nephropathy or contribute to improved bone health , particularly for those living in northern climates .


The study purpose was to examine two different strategies of vitamin D3 supplementation ; daily dosing of 2000IU per day verses monthly dosing of 40,000 IU per month on markers of vitamin D status , bone health and to examine whether adherence , quality of life and patient satisfaction with the supplementation strategy differs between the two vitamin D strategies in adults diagnosed with diabetic nephropathy .


The need for RCTs assessing higher doses of vitamin D3 supplementation at varying frequencies of administration and its impact on bone health in adults with diabetes and chronic kidney disease are needed .


ClinicalTrials.gov NCT01476501 .


Deodorant use during radiation therapy for breast cancer has been controversial as there are concerns deodorant use may exacerbate axillary skin toxicity .


The present study prospectively determined the use of both aluminum-containing and non aluminum containing deodorants on axillary skin toxicity during conventionally fractionated postoperative radiation therapy for breast cancer .


This 3-arm randomized controlled study was conducted at a single center , tertiary cancer hospital between March 2011 and April 2013 .


Participants were randomized to 1 of 2 experimental groups ( aluminum-containing deodorant and soap or non-aluminum containing deodorant and soap ) or a control group ( soap ) .


A total of 333 participants were randomized .


Generalized estimating equations were used to estimate and compare the odds of experiencing high levels of sweating and skin toxicity in each of the deodorant groups to the odds in the control group .


The study evaluated a range of endpoints including objective measurements of axilla sweating , skin toxicity , pain , itch and burning .


Quality of life was assessed with a validated questionnaire .


Radiation characteristics were similar across all groups .


Patients in the deodorant groups did not report significantly different ratings for axillary pain , itch , or burning compared with the control group .


Patients in the aluminum-containing deodorant group experienced significantly less sweating than the control ; the odds of their sweating being barely tolerable and frequently or always interfering with their daily activities was decreased by 85 % ( odds ratio , 0.15 ; 95 % confidence interval , 0.03-0 .91 ) .


We found no evidence that the use of either aluminum-containing or non-aluminum containing deodorant adversely effects axillary skin reaction during conventionally fractionated radiation therapy for breast cancer .


Our analysis also suggests patients in the aluminum-containing deodorant arm had significantly less sweating without increased symptoms of axillary radiation skin toxicity .


These results add to the evidence that the prescription of deodorants during radiation therapy for breast cancer is now questionable .


Ticagrelor outperforms clopidogrel in preventing cardiovascular events in acute coronary syndrome .


Despite the inclusion of a loading dose in the Platelet Inhibition and Patient Outcomes ( PLATO ) trial for all patients randomized to ticagrelor , it may not be necessary in patients receiving ongoing clopidogrel therapy .


The aim of the present study was to assess whether a ticagrelor loading dose is associated with a further platelet inhibition during the switch from clopidogrel to ticagrelor in patients with acute coronary syndrome receiving ongoing antiplatelet treatment .


Fifty patients with acute coronary syndrome receiving aspirin and clopidogrel treatment were randomly assigned to a starting dose of ticagrelor ( group 1 , 90 mg ; group 2 , 180 mg ) .


Platelet aggregation was measured using multiple electrode aggregometry and standard light transmission aggregometry just before the switch and at 2 , 6 , 24 , and 72 hours .


No relevant difference in platelet aggregation was observed between the 2 study arms at baseline ( P = 0.256 ) .


Residual platelet aggregation was significantly reduced in both arms 2 hours after the first administration of ticagrelor ( P < 0.001 for both ) , with no difference in aggregation between groups ( multiple electrode aggregometry , 17.67.2 versus 18.16 U ; P = 0.281 ) .


Similar results were observed with LTA .


Switching from clopidogrel to ticagrelor without a reloading dose is feasible , and it does not hinder platelet aggregation inhibition in patients with acute coronary syndrome .


Further prospective studies are needed to assess the clinical relevance of our findings .


http://www.clinicaltrials.gov .


Unique identifier : NCT01795820 .


To evaluate the association of duration of magnesium sulfate infusion with stillbirth or death , cerebral palsy , and select adverse maternal and neonatal outcomes .


This is a secondary cohort analysis of women randomized to receive magnesium sulfate within a previously reported Maternal-Fetal Medicine Units Network prospective clinical trial .


The association of antenatal infusion of magnesium sulfate for less than 12 hours , 12-18 hours , and greater than 18 hours on maternal and perinatal outcomes was compared .


The primary outcome was cerebral palsy of any severity or death .


Secondary outcomes included cerebral palsy , death , and select maternal and neonatal outcomes .


Stratified and logistic regression analyses were used .


The models were adjusted for race , gestational age at birth , time since last magnesium sulfate , any magnesium sulfate at delivery , and eligibility criteria as appropriate .


Of 933 women available for analysis , 356 , 341 , and 236 received antenatal magnesium sulfate infusion for a total of less than 12 hours , 12-18 hours , or greater than 18 hours , respectively .


Any cerebral palsy or death occurred in 39 women ( 11.7 % ) who received magnesium sulfate less than 12 hours , 34 women ( 10.3 % ) who received 12-18 hours of magnesium sulfate , and 20 women ( 8.8 % ) who received greater than 18 hours of magnesium sulfate .


There was no difference in death or cerebral palsy among groups ( less than 12 hours as reference ; adjusted odds ratio [ OR ] 1.03 , 95 % confidence interval [ CI ] 0.60-1 .77 for 12-18 hours ; adjusted OR 1.08 , 95 % CI 0.57-2 .03 for greater than 18 hours ) .


Select maternal adverse drug affects and neonatal morbidities were also similar across groups .


The duration of antenatal magnesium sulfate infusion is not associated with risk of death or cerebral palsy .


The optimal treatment duration needed for maximal neuroprotection remains unknown .


: II .


Clear directions and explanations from nurses related to health behaviors and discharge procedures have been shown to effectively reduce the risk of patient readmission .


Nurses thus need to develop good communication skills in order to ensure that their communications help patients become better-informed and less anxious about discharge procedures .


This research evaluates the communication skills of nurses following two different education interventions .


Experimental design principles for education interventions were followed in this research .


Medical nurses certified at the N to N2 level in a municipal hospital in Taipei City were enrolled as participants ( N = 78 ) and divided into an experimental group and control group using stratified purposive randomization .


The experimental group received clinical scenario-based simulation education for communication .


The control group received standard class-based education for communication .


Both groups received a pre-test evaluation and an OSCE post-test evaluation .


Results were analyzed using SPSS 17.0 software .


Independent t-test results revealed significant increases in communication skills ( t = 3.406 , p < .05 ) in both groups , with the increase in the experimental group ( M = 5.00 , SD = 0.82 ) significantly greater than the increase in the control group ( M = 4.11 , SD = 1.41 ) .


However , the mean scores from the post-test standardized patient survey found no significant differences between the two groups in terms of communication skills .


The results indicate that the clinical scenario-based simulation education intervention is more effective than traditional class-based education in enhancing the communication skills of nurses .


Abdominal aortic aneurysm patients tend to be informed inconsistently and incompletely about their disorder and the treatment options open to them .


The objective of this trial was to evaluate whether these patients are better informed and experience less decisional conflict regarding their treatment options after viewing a decision aid .


A six-centre , randomised clinical trial comparing a decision aid plus regular information versus regular information from the surgeon .


Included patients had recently been diagnosed with an asymptomatic abdominal aortic aneurysm at least 4 cm in diameter .


The decision aid consisted of a one-time viewing of an interactive CD-ROM elaborating on elective surgery versus watchful waiting .


Generally , the decision aid advised patients with aneurysms less than 5.5 cm to agree to watchful waiting , for larger aneurysms the decision aid provided insight into the balance of benefit and harm of surgical and conservative approaches , taking into account age , co-morbidity and size of the aneurysm .


The primary outcome was patient decisional conflict measured at 1 month follow-up ( Decisional Conflict Scale ) .


Secondary outcomes were patient knowledge , anxiety and satisfaction .


In 178 aneurysm patients , decisional conflict scores did not differ significantly between the decision aid and the regular information groups ( 22 vs. 24 on the 0-100 Decisional Conflict Scale ; p = .33 ) .


Patients in the decision aid group had significantly better knowledge ( 10.0 vs. 9.4 out of 13 points ; p = .04 ) , whereas anxiety levels ( 4.4 and 5.0 on a 0-21 scale ; p = .73 ) and satisfaction scores ( 74 and 73 on a 0-100 scale ; p = .81 ) were similar in both groups .


In addition to regular patient-surgeon communication , a decision aid helps to share treatment decisions with abdominal aortic aneurysm patients by increasing their knowledge about the disorder and available treatment options without raising anxiety levels ; however , it does not reduce decisional conflict , nor does it improve satisfaction .


Patients with isolated locoregional recurrences ( ILRR ) of breast cancer have a high risk of distant metastasis and death from breast cancer .


We aimed to establish whether adjuvant chemotherapy improves the outcome of such patients .


The CALOR trial was a pragmatic , open-label , randomised trial that accrued patients with histologically proven and completely excised ILRR after unilateral breast cancer who had undergone a mastectomy or lumpectomy with clear surgical margins .


Eligible patients were enrolled from hospitals worldwide and were centrally randomised ( 1:1 ) to chemotherapy ( type selected by the investigator ; multidrug for at least four courses recommended ) or no chemotherapy , using permuted blocks , and stratified by previous chemotherapy , oestrogen-receptor and progesterone-receptor status , and location of ILRR .


Patients with oestrogen-receptor-positive ILRR received adjuvant endocrine therapy , radiation therapy was mandated for patients with microscopically involved surgical margins , and anti-HER2 therapy was optional .


The primary endpoint was disease-free survival .


All analyses were by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT00074152 .


From Aug 22 , 2003 , to Jan 31 , 2010 , 85 patients were randomly assigned to receive chemotherapy and 77 were assigned to no chemotherapy .


At a median follow-up of 49 years ( IQR 36-6 0 ) , 24 ( 28 % ) patients had disease-free survival events in the chemotherapy group compared with 34 ( 44 % ) in the no chemotherapy group .


5-year disease-free survival was 69 % ( 95 % CI 56-79 ) with chemotherapy versus 57 % ( 44-67 ) without chemotherapy ( hazard ratio 059 [ 95 % CI 035-099 ] ; p = 0046 ) .


Adjuvant chemotherapy was significantly more effective for women with oestrogen-receptor-negative ILRR ( pinteraction = 0046 ) , but analyses of disease-free survival according to the oestrogen-receptor status of the primary tumour were not statistically significant ( pinteraction = 043 ) .


Of the 81 patients who received chemotherapy , 12 ( 15 % ) had serious adverse events .


The most common adverse events were neutropenia , febrile neutropenia , and intestinal infection .


Adjuvant chemotherapy should be recommended for patients with completely resected ILRR of breast cancer , especially if the recurrence is oestrogen-receptor negative .


US Department of Health and Human Services , Swiss Group for Clinical Cancer Research ( SAKK ) , Frontier Science and Technology Research Foundation , Australian and New Zealand Breast Cancer Trials Group , Swedish Cancer Society , Oncosuisse , Cancer Association of South Africa , Foundation for Clinical Research of Eastern Switzerland ( OSKK ) , Grupo Espaol de Investigacin en Cncer de Mama ( GEICAM ) , and the Dutch Breast Cancer Trialists ' Group ( BOOG ) .


This meta-analysis compared the earliest clinical effects of intra-articular bupivacaine and morphine for pain management following arthroscopic knee surgery .


A comprehensive literature search was conducted using MEDLINE ( 1966 to 2013 ) , the Cochrane Central Register of Controlled Trials ( CENTRAL ) , Embase , and Google Scholar databases for identification of randomized-controlled trials that compared IA bupivacaine and morphine for postoperative pain .


The relative risk , weighted mean difference ( WMD ) , and their corresponding 95 % confidence intervals ( CI ) were calculated using RevMan statistical software .


Bupivacaine and morphine group had similar acute postoperative pain scores ( WMD : 0.07 ; 95 % CI , -0.18 to 0.32 ; P = 0.60 ) ; number of patients requiring supplementary analgesia ( relative risk : 0.74 ; 95 % CI , 0.42 to 1.31 ; P = 0.30 ) for the trials in this meta-analysis ( n = 13 ) ; and side effects ( relative risk : 0.63 ; 95 % CI , 0.39 to 1.02 , P = 0.06 ) .


Even though , the time to first analgesic request resulted in a significant difference ( WMD : 66.59 ; 95 % CI , 11.75 to 122.14 , P = 0.02 ) , this result was not supported by the sensitivity analysis .


On the basis of the currently available literature , this study failed to demonstrate a significant difference between single-dose intra-articular bupivacaine and morphine at the end of the arthroscopic knee surgery in terms of pain relief , need for supplementary analgesics , times interval before the first request for additional analgesic , and short-term side effects .


Level II-meta-analysis of Level I and II studies .


To evaluate the outcome of accelerated and conventional corneal cross-linking ( CXL ) procedures regarding their effect on morphological and optical properties of the cornea .


One hundred fifty-three eyes of 153 patients were evaluated before and during a 15-month follow-up period after CXL ( 76 eyes in the conventional group and 77 eyes in the accelerated group ) .


Measured variables include corrected distance visual acuity ( CDVA ) , uncorrected distance visual acuity ( UDVA ) , refraction , maximum keratometry , endothelial cell density , anterior and posterior stromal keratocyte density , and subbasal nerve density .


All variables were compared between the two study groups .


Cylindrical and spherical components of refraction improved significantly during 15 months of follow-up .


No difference was observed between the two study groups .


UDVA and CDVA improved in the same manner , with no intergroup differences .


Endothelial cell density did not change significantly during the follow-up period in either group .


K-max increased slightly in the first month of the follow-up , but started to decrease at postoperative visits without any significant difference in the two groups .


Anterior stromal keratocyte density and subbasal nerve density decreased significantly in both groups 1 month postoperatively .


Both variables had a more significant decrease in the conventional group at all visits before the 1-year visit .


At the final 15-month visit , there were no significant differences in any value between the two groups .


Accelerated and conventional CXL seem to have a comparable and acceptable effect on keratoconus in the short-term follow-up period .


Axitinib is a potent and selective inhibitor of vascular endothelial growth factor receptors 1-3 , approved for second-line treatment of advanced renal cell carcinoma ( RCC ) .


Preclinical studies did not indicate potential for axitinib-induced delayed cardiac repolarization .


The effect of axitinib on corrected QT ( QTc ) prolongation was evaluated with one-stage concentration-QTc response modeling using data from a definitive randomized crossover QT phase I study in healthy volunteers administered one single 5-mg axitinib dose alone or in the presence of steady-state ketoconazole ( 400mg once daily ) .


Axitinib and ketoconazole had opposite effects on heart rate : Axitinib lowered it , ketoconazole raised it .


The final analysis showed a flat relationship between QTc and axitinib concentration ( slope -0.0314 msmL/ng ) for axitinib alone .


Mean highest placebo-matched change from baseline in QTc was -3.0 [ 90 % confidence interval ( CI ) -5.4 , -0.6 ] ms. At supratherapeutic axitinib exposures achieved with potent cytochrome P450 3A4/5 inhibition by ketoconazole , the model predicted mean QTc change of 6.5 ( 90 % CI 4.4-8 .5 ) ms. The slope population mean estimate was -0.331 ( 95 % CI -0.860 , 0.198 ) msmL/g for ketoconazole alone and 0.0725 ( 0.0445-0 .1005 ) msmL/ng for axitinib in the presence of ketoconazole .


The results were then compared with those obtained based on more widely used Fridericia 's , Bazett 's , and study-specific correction methods .


Since axitinib plasma concentrations observed in this study exceeded the range of concentrations observed in patients with RCC at the highest approved clinical dose ( 10mg twice daily ) , axitinib was not associated with clinically significant QTc prolongation in target populations .


Adolescent metabolic syndrome ( MetS ) predicts type 2 diabetes mellitus and subclinical atherosclerosis in adulthood .


Our aim was to establish the relationship between an infancy-onset dietary intervention and risk of having MetS between 15 and 20 years of age .


The Special Turku Coronary Risk Factor Intervention Project for Children ( STRIP ) study is a longitudinal , randomized atherosclerosis prevention trial in which repeated dietary counseling aiming at reducing intake of saturated fat took place from infancy to early adulthood .


Participants who had complete data on the MetS components ( waist circumference , blood pressure , triglycerides , glucose , high-density lipoprotein cholesterol ) at 15 ( n = 512 ) , 16 ( n = 485 ) , 17 ( n = 475 ) , 18 ( n = 459 ) , 19 ( n = 439 ) , and 20 ( n = 407 ) years of age were included in the study .


Modified International Diabetes Foundation criteria with 80th/20th percentile cutoff points for the components were primarily applied in statistical analyses , and the results were replicated with the use of other pediatric MetS definitions .


Between the ages of 15 and 20 years , the prevalence of MetS varied between 6.0 % and 7.5 % in participants in the intervention group and between 10 % and 14 % in the control group .


The long-term relative risk of MetS was significantly lower in the intervention group ( relative risk , 0.59 ; 95 % confidence interval , 0.40-0 .88 ; P = 0.009 ) .


Of the individual MetS components , the intervention decreased risk of high blood pressure in both sexes ( relative risk , 0.83 ; 95 % confidence interval , 0.70-0 .99 ) and high triglycerides in male subjects ( relative risk , 0.71 ; 95 % confidence interval , 0.52-0 .98 ) .


A statistically nonsignificant reduction was seen in the risk of high waist circumference in the intervention individuals ( relative risk , 0.78 ; 95 % confidence interval , 0.59-1 .03 ) .


Repeated infancy-onset dietary intervention is effective in the prevention of MetS in adolescence .


http://www.clinicaltrials.gov .


Unique identifier : NCT00223600 .


To evaluate the clinical efficacy of the coronary sinus ( CS ) Reducer in attenuating angina severity in patients suffering from severe refractory angina .


Patients with refractory angina , objective evidence of myocardial ischaemia and no option for revascularisation were treated with CS Reducer implantation at two medical centres .


Six-month follow-up evaluation consisted of clinical assessment of angina severity .


Objective assessment of ischaemia at six-month follow-up was performed in one of the two centres .


Successful CS Reducer implantation was achieved in 21 of 23 eligible patients , at both centres .


No device-related adverse effects were observed during the procedure or the follow-up period .


Canadian Cardiovascular Society ( CCS ) score diminished from a mean of 3.3 at baseline to 2.0 at six months ( n = 20 , p < 0.01 ) , exercise duration was prolonged from 3:16 to 5:16 min ( min : sec ; n = 8 , p = 0.05 ) .


Thallium SPECT summed stress score and summed difference score were both reduced ( n = 9 , 21.510 vs. 13.29 , p = 0.01 , and 11.16 vs. 4.74 , p = 0.007 , respectively ) .


Wall motion score index at peak dobutamine infusion was also significantly improved ( n = 8 , 1.90.4 vs. 1.40.4 , p = 0.046 ) .


CS Reducer implantation was safe and resulted in significant improvement of angina class .


The results of the ongoing randomised sham-control trial will address the concern regarding the possible placebo effect , and hopefully further support our encouraging observations .


To evaluate whether an epidural steroid injection or gabapentin is a better treatment for lumbosacral radiculopathy .


A multicenter randomized study conducted between 2011 and 2014 .


Computer generated randomization was stratified by site .


Patients and evaluating physicians were blinded to treatment outcomes .


Eight military , Veterans Administration , and civilian hospitals .


145 people with lumbosacral radicular pain secondary to herniated disc or spinal stenosis for less than four years in duration and in whom leg pain is as severe or more severe than back pain .


Participants received either epidural steroid injection plus placebo pills or sham injection plus gabapentin .


Average leg pain one and three months after the injection on a 0-10 numerical rating scale .


A positive outcome was defined as a 2 point decrease in leg pain coupled with a positive global perceived effect .


All patients had one month follow-up visits ; patients whose condition improved remained blinded for their three month visit .


There were no significant differences for the primary outcome measure at one month ( mean pain score 3.3 ( SD 2.6 ) and mean change from baseline -2.2 ( SD 2.4 ) in epidural steroid injection group versus 3.7 ( SD 2.6 ) and -1.7 ( SD 2.6 ) in gabapentin group ; adjusted difference 0.4 , 95 % confidence interval -0.3 to 1.2 ; P = 0.25 ) and three months ( mean pain score 3.4 ( SD 2.7 ) and mean change from baseline -2.0 ( SD 2.6 ) versus 3.7 ( SD 2.8 ) and -1.6 ( SD 2.7 ) , respectively ; adjusted difference 0.3 , -0.5 to 1.2 ; P = 0.43 ) .


Among secondary outcomes , one month after treatment those who received epidural steroid injection had greater reductions in worst leg pain ( -3.0 , SD 2.8 ) than those treated with gabapentin ( -2.0 , SD 2.9 ; P = 0.04 ) and were more likely to experience a positive successful outcome ( 66 % v 46 % ; number needed to treat = 5.0 , 95 % confidence interval 2.8 to 27.0 ; P = 0.02 ) .


At three months , there were no significant differences between treatments .


Although epidural steroid injection might provide greater benefit than gabapentin for some outcome measures , the differences are modest and are transient for most people.Trial registration ClinicalTrials.gov Identifier : NCT01495923 .


This study sought to examine the utility of hair testing as a research measure of drug use among individuals with moderate-risk drug use based on the internationally validated Alcohol , Smoking , and Substance Involvement Screening Test ( ASSIST ) .


This study is a secondary analysis using baseline data from a randomized trial of brief intervention for drug misuse , in which 360 adults with moderate-risk drug use were recruited from two community clinics in New Mexico , USA .


The current study compared self-reported drug use on the ASSIST with laboratory analysis of hair samples using a standard commercially available 5-panel test with assay screening and gas chromatography/mass spectrometry ( GC/MS ) confirmation .


Both self-report and hair testing covered a 3-month period .


Overall concordance between hair testing and self-report was 57.5 % ( marijuana ) , 86.5 % ( cocaine ) , 85.8 % ( amphetamines ) , and 74.3 % ( opioids ) .


Specificity of hair testing at standard laboratory cut-offs exceeded 90 % for all drugs , but sensitivity of hair testing relative to self-report was low , identifying only 52.3 % ( 127/243 ) of self-disclosed marijuana users , 65.2 % ( 30/46 ) of cocaine users , 24.2 % ( 8/33 ) of amphetamine users , and 2.9 % ( 2/68 ) of opioid users .


Among participants who disclosed using marijuana or cocaine in the past 3 months , participants with a negative hair test tended to report lower-frequency use of those drugs ( p < .001 for marijuana and cocaine ) .


Hair testing can be useful in studies with moderate-risk drug users , but the potential for under-identification of low-frequency use suggests that researchers should consider employing low detection cut-offs and using hair testing in conjunction with self-report .


Fingertip injuries , which are the most common hand injury , represent management challenges for hand surgeons .


Full thickness skin grafts are routinely used to cover the fingertip site , but has significant donor site morbidity .


As amniotic membranes ( AM ) are used as a dressing substitute in burns , we decided to evaluate the efficacy of AM as a biologic wound dressing material for coverage of these injuries .


In this clinical study , 30 patients with full-thickness zone 1 fingertip skin loss were included .


The patients were divided into 2 groups using the block randomisation method .


In the first group , a skin graft was used for coverage and in the second group , AM was used .


All patients were operated on by the same hand surgeon between February 2012 to October 2012 .


The minimum follow-up period was 6 months .


Two point discrimination ( T.P.D ) , light touch , healing time , days lost from work and infection rate were evaluated and recorded .


This study recruited 30 patients with full-thickness zone 1 fingertip skin loss ( age range 13-47 years ) .


Fingertips in both groups were assessed .


T.P.D , light touch and days lost from work were significantly lower in the AM group than in the skin graft group .


Healing time was lower in the skin graft group .


In the both groups , no infection was detected .


Patients of both groups were satisfied of their treatment and healing progress .


Our results showed the effectiveness and safety of AM for the treatment of fingertip amputation , which can produce better sensation and functional outcomes than skin graft transplantations .


To identify the effects of a brief educational intervention on stroke patients ' recall and recognition of risk factors and performance of and stage of change for stroke risk-related behaviors .


Sixty-six patients with stroke participated in a multisite randomized controlled trial .


The intervention group ( n = 35 ) received a brief education intervention ( tailored written stroke information , verbal reinforcement of information for 3 months after discharge , and provision of a telephone number ) .


The control group ( n = 31 ) received usual care .


Unprompted recall ( personal and general ) , prompted recognition of risk factors ( 0-13 ) , and performance of ( 0-10 ) and stage of change for up to 7 stroke risk-related behaviors were assessed before and 3 months after discharge .


No significant between-group differences were found .


For all participants over time , there were significant improvements for personal ( mean difference [ MD ] , 0.3 ; 95 % CI , 0.004-0 .69 ; P = .05 ) and general ( MD , 0.6 ; 95 % CI , 0.09-1 .16 ; P = .02 ) risk factor recall ; performance of stroke risk-related behaviors ( MD , 0.8 ; 95 % CI , 0.28-1 .26 ; P < .01 ) ; and progression from a nonaction to an action stage of change for 4 of 7 behaviors over time .


There was a significant decline in total risk factor recognition scores ( MD , -0.8 ; 95 % CI , 0.39-1 .13 ; P < .01 ) .


Stroke patients ' unprompted recall of risk factors and performance of risk-related behaviors improved over time ; readiness to change risk-related behaviors progressed for some behaviors .


A brief educational intervention did not improve risk factor awareness or behavior change more than usual care .


Epidermal growth factor receptor overexpression is associated with poor outcomes in urothelial carcinoma ( UC ) .


Cetuximab ( CTX ) exhibited an antitumor effect in in vivo UC models .


The efficacy of gemcitabine/cisplatin ( GC ) with or without CTX in patients with advanced UC was evaluated .


Patients with advanced UC , measurable disease , and adequate organ function were randomized 1:2 to cisplatin ( 70 mg/m ( 2 ) ) on day 1 plus gemcitabine ( 1000 mg/m ( 2 ) ) on days 1 , 8 , and 15 ( arm A ) or GC plus CTX ( 500 mg/m ( 2 ) ) on days 1 and 15 ( arm B ) .


The primary endpoint was the overall response rate .


The secondary endpoints were the response duration , safety , progression-free survival , overall survival , determination of whether or not CTX sensitized nonresponders to GC , and exploratory biomarker analysis .


The accrual targets were 27 and 54 patients for the 2 arms , respectively .


The overall response rate was reported by arm with binomial confidence intervals ( CIs ) .


Kaplan-Meier methods were used for time-to-event endpoints .


Eighty-eight eligible patients were randomized ; 87 were toxicity-evaluable , and 85 were response-evaluable .


The overall response rates were 57.1 % for arm A ( 95 % CI = 37 % -76 % ) and 61.4 % for arm B ( 95 % CI = 48 % -74 % ) .


The median progression-free survival times were 8.5 months for arm A ( 95 % CI = 5.7-10 .4 months ) and 7.6 months for arm B ( 95 % CI = 6.1-8 .7 months ) .


The median overall survival times were 17.4 months for arm A ( 95 % CI = 12.8 months to unreached ) and 14.3 months for arm B ( 95 % CI = 11.6-22 .2 months ) .


The most common grade 3/grade 4 adverse events in both arms were myelosuppression and nausea .


Thromboembolism , acneiform rash , fatigue , pain , hypersensitivity reactions , elevated transaminases , hyponatremia , and hypomagnesemia were more common in arm B ; 3 grade 5 adverse events occurred in arm B.


The presence of primary disease significantly correlated with thromboembolism .


An increased soluble E-cadherin level after cycle 2 correlated with a higher risk of death .


GC plus CTX was feasible but was associated with more adverse events and no improvements in outcomes .


Infections with soil-transmitted helminths ( Ascaris lumbricoides , hookworm , and Trichuris trichiura ) are widespread and often occur concomitantly .


These parasitic-worm infections are typically treated with albendazole or mebendazole , but both drugs show low efficacy against T. trichiura .


Albendazole is the drug of choice against hookworm .


In this double-blind trial conducted on Pemba Island , Tanzania , we randomly assigned children , 6 to 14 years of age , to receive one of four treatments : oxantel pamoate at a dose of 20 mg per kilogram of body weight , plus 400 mg of albendazole , administered on consecutive days ; oxantel pamoate at a single dose of 20 mg per kilogram ; albendazole at a single dose of 400 mg ; or mebendazole at a single dose of 500 mg .


We assessed the efficacy and safety profile of oxantel pamoate-albendazole when used in the treatment of T. trichiura infection ( primary outcome ) and concomitant soil-transmitted helminth infection ( secondary outcome ) .


Efficacy was determined by means of assessment of the cure rate and egg-reduction rate .


Adverse events were assessed four times after treatment .


Complete data were available for 458 children , of whom 450 were infected with T. trichiura , 443 with hookworm , and 293 with A. lumbricoides .


The cure rate of T. trichiura infection was significantly higher with oxantel pamoate-albendazole than with mebendazole ( 31.2 % vs. 11.8 % , P = 0.001 ) , as was the egg-reduction rate ( 96.0 % [ 95 % confidence interval { CI } , 93.5 to 97.6 ] vs. 75.0 % [ 95 % CI , 64.2 to 82.0 ] ) .


The cure rate with albendazole ( 2.6 % ) and the egg-reduction rate with albendazole ( 45.0 % ; 95 % CI , 32.0 to 56.4 ) were significantly lower than the rates with mebendazole ( P = 0.02 for the comparison of cure rates ) .


Oxantel pamoate had low efficacy against hookworm and A. lumbricoides .


Adverse events ( mainly mild ) were reported by 30.9 % of all children .


Treatment with oxantel pamoate-albendazole resulted in higher cure and egg-reduction rates for T. trichiura infection than the rates with standard therapy .


( Funded by the Medicor Foundation and the Swiss National Science Foundation ; Current Controlled Trials number , ISRCTN54577342 . )


The aim of the current study was to analyze the type of variations in expression profiles of matrix metalloproteinase 2 ( MMP2 ) , matrix metalloproteinase 9 ( MMP9 ) , tissue inhibitor of metalloproteinase 2 ( TIMP2 ) , and vascular endothelial growth factor A ( VEGFA ) before and after radiochemotherapy in patients with locally advanced FIGO stage Ib-IIb cervical cancer .


We analyzed the role of these biomarkers in monitoring response to treatment .


Serum from 72 patients with cervical cancer treated within a phase III trial with either simultaneous radiochemotherapy ( S-RC ) with cisplatin , or systemic paclitaxel and carboplatin followed by percutaneous radiation ( PC-R ) was analyzed by ELISA .


Sera were obtained during surgery and after the end of adjuvant treatment .


The median age at time of diagnosis was 46 years ( range = 30-71 years ) .


The most common histological types were squamous cell ( 73.6 % ) and adenocarcinoma ( 25 % ) .


Thirty-five ( 48.6 % ) patients underwent surgery followed by S-RC and 37 ( 51.4 % ) patients were treated with surgery followed by PC-R .


Five patients developed recurrence within six months after radiochemotherapy .


VEGFA levels were significantly higher before and after adjuvant treatment in patients who developed early recurrence ( p = 0.001 ) .


An increase of more than 500 pg/ml VEGFA and a decrease of more than 9 % of the pre-therapeutic value of TIMP2 were significantly associated with a higher risk of early recurrence ( RR = 8.5 , 95 % CI = 1.8-39 .8 and RR = 11.0 , 95 % CI = 2.5-48 .2 , respectively ) .


TIMP2 expression and risk score for early relapse ( which is calculated using values of VEGFA and TIMP2 ) were independent prognostic factors for overall survival ( p = 0.043 , HR = 0.96 , 95 % CI = 0.93-0 .99 and p = 0.002 , HR = 1.09 , 95 % CI = 1.03-1 .15 , respectively ) .


Our results indicate a predictive value of VEGFA and TIMP2 in monitoring cervical cancer patients undergoing radiochemotherapy .


Lumbosacral radicular syndrome ( LRS ) is a self-limiting , benign , painful and impairing condition caused by lumbar disc herniation and inflammatory processes around the nerve root .


Segmental epidural steroid injections ( SESIs ) are helpful to reduce radicular pain on a short-term basis .


It is unknown whether SESIs are an effective addition to usual pain treatment of LRS in general practice .


In our study , we assessed the effectiveness of SESIs on pain and disability as an addition to usual care for acute LRS in general practice .


A pragmatic , single-blinded , randomized controlled trial in Dutch general practice was conducted .


Circumstances of daily practice were closely followed .


Care as usual ( CAU ) was compared to care as usual combined with an additional SESI in 63 patients in the acute phase of LRS .


To detect a minimal clinically important difference of 1.2 points on a numerical rating scale for back pain and a common within-group standard deviation of 1.7 with a two-tailed alpha of 0.05 and a power of 0.80 , we needed 33 subjects in each group .


Statistical analysis was carried out using mixed models .


A small significant effect in favour of the intervention , corrected for age , sex and baseline values , was found for back pain , impairment and Roland-Morris disability score .


The differences , though statistically significant , were too small to be considered clinically relevant .


Patients from the intervention group were significantly more satisfied with the received treatment than patients from the control group .


We found a small , statistically significant , but not clinically relevant positive effect of SESIs on back pain , impairment and disability in acute LRS .


We do not recommend implementing SESIs as an additional regular treatment option in general practice .


Antiretroviral preexposure prophylaxis ( PrEP ) , using tenofovir disoproxil fumarate ( TDF ) and combination emtricitabine/tenofovir disoproxil fumarate ( FTC+TDF ) , is efficacious for prevention of human immunodeficiency virus ( HIV ) acquisition .


PrEP could reduce periconception HIV risk , but the effect on pregnancy outcomes is not well defined .


To assess pregnancy incidence and outcomes among women using PrEP during the periconception period .


Randomized trial among 1785 HIV-serodiscordant heterosexual couples ( the Partners PrEP Study ) in which the female partner was HIV uninfected that demonstrated that PrEP was efficacious for HIV prevention , conducted between July 2008 and June 2013 at 9 sites in Kenya and Uganda .


Daily oral TDF ( n = 598 ) , combination FTC+TDF ( n = 566 ) , or placebo ( n = 621 ) through July 2011 , when PrEP demonstrated efficacy for HIV prevention .


Thereafter , participants continued receiving active PrEP without placebo .


Pregnancy testing occurred monthly and study medication was discontinued when pregnancy was detected .


Pregnancy incidence , birth outcomes ( live births , pregnancy loss , preterm birth , congenital anomalies ) , and infant growth .


A total of 431 pregnancies occurred .


Pregnancy incidence was 10.0 per 100 person-years among women assigned placebo , 11.9 among those assigned TDF ( incidence difference , 1.9 ; 95 % CI , -1.1 to 4.9 [ P = .22 vs placebo ] ) , and 8.8 among those assigned FTC+TDF ( incidence difference , -1.3 ; 95 % CI , -4.1 to 1.5 [ P = .39 vs placebo ] ) .


Before discontinuation of the placebo treatment group in July 2011 , the occurrence of pregnancy loss ( 96 of 288 pregnancies ) was 42.5 % for women receiving FTC+TDF compared with 32.3 % for those receiving placebo ( difference for FTC+TDF vs placebo , 10.2 % ; 95 % CI , -5.3 % to 25.7 % ; P = .16 ) and was 27.7 % for those receiving TDF alone ( difference vs placebo , -4.6 % ; 95 % CI , -18.1 % to 8.9 % ; P = .46 ) .


After July 2011 , the frequency of pregnancy loss ( 52 of 143 pregnancies ) was 37.5 % for FTC+TDF and 36.7 % for TDF alone ( difference , 0.8 % ; 95 % CI , -16.8 % to 18.5 % ; P = .92 ) .


Occurrence of preterm birth , congenital anomalies , and growth throughout the first year of life did not differ significantly for infants born to women who received PrEP vs placebo .


Among HIV-serodiscordant heterosexual African couples , differences in pregnancy incidence , birth outcomes , and infant growth were not statistically different for women receiving PrEP with TDF alone or combination FTC+TDF compared with placebo at conception .


Given that PrEP was discontinued when pregnancy was detected and that CIs for the birth outcomes were wide , definitive statements about the safety of PrEP in the periconception period can not be made .


These results should be discussed with HIV-uninfected women receiving PrEP who are considering becoming pregnant .


clinicaltrials.gov Identifier : NCT00557245 .


Tribulus terrestris as a herbal remedy has shown beneficial aphrodisiac effects in a number of animal and human experiments .


This study was designed as a randomized double-blind placebo-controlled trial to assess the safety and efficacy of Tribulus terrestris in women with hypoactive sexual desire disorder during their fertile years .


Sixty seven women with hypoactive sexual desire disorder were randomly assigned to Tribulus terrestris extract ( 7.5 mg/day ) or placebo for 4weeks .


Desire , arousal , lubrication , orgasm , satisfaction , and pain were measured at baseline and after 4weeks after the end of the treatment by using the Female Sexual Function Index ( FSFI ) .


Two groups were compared by repeated measurement ANOVA test .


Thirty women in placebo group and thirty women in drug group completed the study .


At the end of the fourth week , patients in the Tribulus terrestris group had experienced significant improvement in their total FSFI ( p < 0.001 ) , desire ( p < 0.001 ) , arousal ( p = 0.037 ) , lubrication ( p < 0.001 ) , satisfaction ( p < 0.001 ) and pain ( p = 0.041 ) domains of FSFI .


Frequency of side effects was similar between the two groups .


Tribulus terrestris may safely and effectively improve desire in women with hypoactive sexual desire disorder .


Further investigation of Tribulus terrestris in women is warranted .


Patients who undergo cardiac catheterization or percutaneous coronary intervention ( PCI ) often have a poor understanding of their disease and of related therapeutic risks , benefits , and alternatives .


This pilot study was undertaken to compare the effectiveness of 2 preprocedural educational approaches to enhance patients ' knowledge of standard consent elements .


Patients undergoing first-time elective , outpatient cardiac catheterization and possible PCI were randomly assigned to a scripted verbal or written consent process ( group I ) or a web-based , audiovisual presentation ( group II ) .


Preconsent and postconsent questionnaires were administered to evaluate changes in patients ' self-reported understanding of standard consent elements .


One hundred and two patients enrolled at a single institution completed the pre - and postconsent surveys ( group I = 48 ; group II = 54 ) .


Changes in patient comprehension rates were similar between groups for risk and benefit consent elements , but group II had significantly greater improvement in the identification of treatment alternatives than group I ( p = 0.028 ) .


Independent of intervention , correct identification of all risks and alternatives increased significantly after consent ( p < 0.05 ) ; 4 of 5 queried risks were correctly identified by greater than 90 % of respondents .


However , misperceptions of benefits persisted after consent ; increased survival and prevention of future myocardial infarction were identified as PCI-related benefits by 83 % and 46 % of respondents , respectively .


Although both scripted verbal and audiovisual informed consent improved patient comprehension , important patient misperceptions regarding PCI-related outcomes and alternatives persist , independent of informed consent approach , and considerable challenges still exist in educating patients about contemplated medical procedures .


Future research appears warranted to improve patient comprehension .


Epidemiological data on the prevalence of headache in nursing staff in Mainland China are lacking .


We therefore performed a study to assess the prevalence of headache , and factors associated with headaches , in nursing staff in three hospitals in North China .


Stratified random cluster sampling was used to select 1102 nurses from various departments in three hospitals .


A structured questionnaire was used to collect epidemiological data , headache characteristics and associated factors .


The response rate was 93.0 % .


Among nursing staff , the 1-year prevalence of primary headache disorders was 45.3 % , of migraine 14.8 % ( migraine with aura 3.4 % , migraine without aura 11.4 % ) , of tension-type headache ( TTH ) 26.2 % , of chronic daily headache ( CDH ) 2.7 % .


Multivariate analysis showed that seniority ( 5 years ) was a risk factor for migraine ( OR 2.280 ) , obesity ( BMI25 ) was a risk factor for TTH and CDH ( OR 1.684 and 3.184 ) , and age ( 40 years ) was a risk factor for CDH ( OR 8.455 ) .


Nurses working in internal medicine were more likely to suffer CDH than those in other departments .


Working a greater number of night shifts was also associated with increased prevalence of headache .


The prevalence of primary headache disorders in nurses is higher than that in the general population in China , and occupational factors may play an important role .


Therefore , the prevalence of headache in nurses should be a focus of attention , and coping strategies should be provided .


Such measures could contribute to improving patient care .


This open-label study evaluated the effects of fentanyl buccal tablet ( FBT ) on functioning and mood in cancer patients with breakthrough cancer pain ( BTcP ) .


Opioid-tolerant patients in seven European countries with up to four BTcP episodes/day received FBT doses ( 100-800 g ) identified during open-label titration to treat up to eight BTcP episodes during an open-label treatment period .


In countries where FBT was not commercially available , patients could enter an open-label continuation phase .


Functionality and satisfaction assessments included change from baseline to the end of the treatment period in the modified Brief Pain Inventory ( BPI-7S ) seven-item interference subscale , patient 's global assessment of satisfaction and ease of use , and Patient 's Global Impression of Change ( PGIC ) .


Safety was also assessed .


Of 330 randomized patients , 218 completed the treatment period and 88 entered the continuation phase .


Median background pain intensity was 4.0 ( mild ) throughout the study .


After the treatment period , mean ( SD ) global modified BPI-7S score improved from 39.7 ( 15.9 ) at baseline to 31.6 ( 16.8 ) for a mean change of -8.6 ( 95 % confidence interval CI -10.5 , -6.7 ; P < 0.0001 ) , and 74.5 % of patients reported improvement in overall status ( PGIC ) compared with 25.5 % who reported no change or worsening ( P < 0.001 ) .


Treatment-related adverse events ( 2 patients ) during the continuation phase were application site erythema ( 6.9 % ) , application site swelling ( 4.6 % ) , and vertigo ( 4.6 % ) .


FBT may improve patient functioning , mood , and overall satisfaction in the management of BTcP .


Long-term data did not indicate new safety concerns with FBT doses up to 800 g.


Enteral administration of immune-modulating nutrients ( eg , glutamine , omega-3 fatty acids , selenium , and antioxidants ) has been suggested to reduce infections and improve recovery from critical illness .


However , controversy exists on the use of immune-modulating enteral nutrition , reflected by lack of consensus in guidelines .


To determine whether high-protein enteral nutrition enriched with immune-modulating nutrients ( IMHP ) reduces the incidence of infections compared with standard high-protein enteral nutrition ( HP ) in mechanically ventilated critically ill patients .


The MetaPlus study , a randomized , double-blind , multicenter trial , was conducted from February 2010 through April 2012 including a 6-month follow-up period in 14 intensive care units ( ICUs ) in the Netherlands , Germany , France , and Belgium .


A total of 301 adult patients who were expected to be ventilated for more than 72 hours and to require enteral nutrition for more than 72 hours were randomized to the IMHP ( n = 152 ) or HP ( n = 149 ) group and included in an intention-to-treat analysis , performed for the total population as well as predefined medical , surgical , and trauma subpopulations .


High-protein enteral nutrition enriched with immune-modulating nutrients vs standard high-protein enteral nutrition , initiated within 48 hours of ICU admission and continued during the ICU stay for a maximum of 28 days .


The primary outcome measure was incidence of new infections according to the Centers for Disease Control and Prevention ( CDC ) definitions .


Secondary end points included mortality , Sequential Organ Failure Assessment ( SOFA ) scores , mechanical ventilation duration , ICU and hospital lengths of stay , and subtypes of infections according CDC definitions .


There were no statistically significant differences in incidence of new infections between the groups : 53 % ( 95 % CI , 44 % -61 % ) in the IMHP group vs 52 % ( 95 % CI , 44 % -61 % ) in the HP group ( P = .96 ) .


No statistically significant differences were observed in other end points , except for a higher 6-month mortality rate in the medical subgroup : 54 % ( 95 % CI , 40 % -67 % ) in the IMHP group vs 35 % ( 95 % CI , 22 % -49 % ) in the HP group ( P = .04 ) , with a hazard ratio of 1.57 ( 95 % CI , 1.03-2 .39 ; P = .04 ) for 6-month mortality adjusted for age and Acute Physiology and Chronic Health Evaluation II score comparing the groups .


Among adult patients breathing with the aid of mechanical ventilation in the ICU , IMHP compared with HP did not improve infectious complications or other clinical end points and may be harmful as suggested by increased adjusted mortality at 6 months .


These findings do not support the use of IMHP nutrients in these patients .


trialregister.nl Identifier : NTR2181 .


Although limitation of pronation/supination following both-bone forearm fractures in children is often attributed to an angular malunion , no clinical study has compared pronation/supination and angular malalignment of the same child by analysis of prospectively collected clinical data .


The purpose of this trial is to explore whether limitation of pronation/supination can be predicted by the degree of angular malalignment in children who sustained a both-bone forearm fracture .


In four Dutch hospitals , children aged 16 years with a both-bone forearm fracture were prospectively followed up consecutive children for 6-9 months .


At the final follow-up , pronation/supination and angular malunion on radiographs were determined .


Between January 2006 and August 2010 , a total of 410 children were prospectively followed up , of which 393 children were included for analysis in this study .


The mean age of the children was 8.0 ( 3.5 ) years , of which 63 % were male and 40 % fractured their dominant arm .


The mean time to final examination was 219 ( 51 ) days .


Children with a metaphyseal both-bone fracture of the distal forearm with an angular malalignment of 15 had a 9-13 % chance of developing a clinically relevant limitation ( i.e. , < 50 of pronation and/or supination ) , while children with an angular malalignment of 16 had a 60 % chance .


Children with diaphyseal both-bone forearm fractures with 5 of angular malalignment had a 13 % chance of developing a clinically relevant limitation , which showed no significant increase with a further increase of angular malalignment .


Children who sustained a both-bone forearm fracture localised in the distal metaphysis have a higher chance of developing a clinically relevant limitation of forearm rotation in case of a more severe angular malalignment , while children with a diaphyseal both-bone forearm fracture had a moderate chance of limitation , irrespective of the severity of the angular malalignment .


A double-blind placebo-controlled study was conducted according to EMA guidelines , to evaluate safety , tolerability and short-term treatment effects of three updosing regimens of Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy .


Forty-eight patients were randomized to groups : A ( six weekly doses ) , B ( eight weekly doses ) or C ( eight doses , two clustered doses over 3 weeks ) .


The most frequent adverse events were local reactions .


No serious adverse events were found .


Severe systemic reactions were reported more frequently in Group C. Decreased cutaneous responses and increased specific IgGs were shown in all active groups , even within the short-term .


Dermatophagoides pteronyssinus subcutaneous allergen immunotherapy in depot presentation exhibited good safety and tolerability .


Group A seemed to show the best profile for further clinical development .


The treatment of symptomatic acromioclavicular joint ( ACJ ) injury in the rotator cuff ( RC ) tear has not been well clarified .


To compare the clinical results between patients who had distal clavicle resection ( DCR ) and those who did not during RC repair .


Randomized controlled trial ; Level of evidence , 1 .


From August 2008 to December 2009 , a total of 56 consecutive patients ( 58 shoulders ) were included .


All patients had either a full-thickness or high-grade ( > 50 % ) RC tear , ACJ tenderness , arthritic change visible on plain radiographs , and a positive ACJ lidocaine injection test the day before surgery .


Patients were randomized into 2 groups : DCR and RC repair ( DCR+RCR group ) and RC repair only ( isolated RCR ) .


Evaluation was performed preoperatively , at 6 months postoperatively , and at a final follow-up a minimum of 24 months postoperatively using the American Shoulder and Elbow Surgeons ( ASES ) score , the Constant shoulder score , range of motion examination , and pain visual analog scale ( VAS ) .


After simple randomization , 26 shoulders were allocated in the DCR+RCR group , and 32 were placed in the isolated RCR group .


Five shoulders in the DCR+RCR group and 6 in the isolated RCR group were excluded from analysis due to loss of follow-up .


Therefore , the evaluation was performed for 21 shoulders in the DCR+RCR group and 26 shoulders in the isolated RCR group .


The mean follow-up period was 44.2 months in the DCR+RCR group and 44.0 months in the isolated RCR group .


There were no differences in age , sex , symptom duration , RC tear size , or preoperative ASES , Constant , and VAS scores between the 2 groups ( P > .05 ) .


At final follow-up , the ASES , Constant , and VAS scores were significantly improved in both groups ( P < .001 ) .


There were no differences in ASES , Constant , and VAS scores between the 2 groups at final follow-up ( P > .05 ) , and there was no difference in residual ACJ tenderness ( 7 in the DCR+RCR group and 5 in the isolated RCR group ) between the 2 groups ( P = .270 ) .


There was no difference in the clinical evaluations between the combined arthroscopic DCR and RCR group and the isolated RCR group at a minimum 24-month follow-up .


Arthroscopic DCR should be carefully considered in patients who have symptomatic ACJ arthritis with RC tears .


Although catheter ablation is an effective rhythm control strategy for atrial fibrillation ( AF ) , empirically-based ablation has a substantial recurrence rate .


The purposes of this study were to develop a computational platform for patient-specific virtual AF ablation and to compare the anti-fibrillatory effects of 5 different virtual ablation protocols with empirically chosen clinical ablations .