The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy ( ELA ) with adjunctive percutaneous transluminal angioplasty ( PTA ) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis ( ISR ) .


Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia , although treating post-stenting artery reobstruction , or ISR , remains challenging .


The multicenter , prospective , randomized , controlled EXCITE ISR ( EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis ) trial was conducted across 40 U.S. centers .


Patients with Rutherford Class 1 to 4 and lesions of target lesion length 4 cm , vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio .


The primary efficacy endpoint was target lesion revascularization ( TLR ) at 6-month follow up .


The primary safety endpoint was major adverse event ( death , amputation , or TLR ) at 30 days post-procedure .


Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis .


A total of 169 ELA + PTA subjects ( 62.7 % male ; mean age 68.5 9.8 years ) and 81 PTA patients ( 61.7 % male ; mean age 67.8 10.3 years ) were enrolled .


Mean lesion length was 19.6 12.0 cm versus 19.3 11.9 cm , and 30.5 % versus 36.8 % of patients exhibited total occlusion .


ELA + PTA subjects demonstrated superior procedural success ( 93.5 % vs. 82.7 % ; p = 0.01 ) with significantly fewer procedural complications .


ELA + PTA and PTA subject 6-month freedom from TLR was 73.5 % versus 51.8 % ( p < 0.005 ) , and 30-day major adverse event rates were 5.8 % versus 20.5 % ( p < 0.001 ) , respectively .


ELA + PTA was associated with a 52 % reduction in TLR ( hazard ratio : 0.48 ; 95 % confidence interval : 0.31 to 0.74 ) .


The EXCITE ISR trial is the first large , prospective , randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR .


( Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [ EXCITE ISR ] ; NCT01330628 ) .


In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion , intraarterial treatment is highly effective for emergency revascularization .


However , proof of a beneficial effect on functional outcome is lacking .


We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone .


Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset .


The primary outcome was the modified Rankin scale score at 90 days ; this categorical scale measures functional outcome , with scores ranging from 0 ( no symptoms ) to 6 ( death ) .


The treatment effect was estimated with ordinal logistic regression as a common odds ratio , adjusted for prespecified prognostic factors .


The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores , as compared with usual care alone ( shift analysis ) .


We enrolled 500 patients at 16 medical centers in The Netherlands ( 233 assigned to intraarterial treatment and 267 to usual care alone ) .


The mean age was 65 years ( range , 23 to 96 ) , and 445 patients ( 89.0 % ) were treated with intravenous alteplase before randomization .


Retrievable stents were used in 190 of the 233 patients ( 81.5 % ) assigned to intraarterial treatment .


The adjusted common odds ratio was 1.67 ( 95 % confidence interval [ CI ] , 1.21 to 2.30 ) .


There was an absolute difference of 13.5 percentage points ( 95 % CI , 5.9 to 21.2 ) in the rate of functional independence ( modified Rankin score , 0 to 2 ) in favor of the intervention ( 32.6 % vs. 19.1 % ) .


There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage .


In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation , intraarterial treatment administered within 6 hours after stroke onset was effective and safe .


( Funded by the Dutch Heart Foundation and others ; MR CLEAN Netherlands Trial Registry number , NTR1804 , and Current Controlled Trials number , ISRCTN10888758 . )


To test the efficacy of self-regulation ( SR ) for promoting task performance and motor and cognitive functions .


Pilot randomized controlled trial .


Rehabilitation unit .


Inpatients with acute poststroke ( N = 44 ) after a cerebral infarction aged 60 years .


Patients were randomly assigned to the SR ( n = 24 ) or functional rehabilitation ( control ; n = 20 ) intervention .


The SR intervention consisted of 1 week of therapist-supervised practices of daily tasks using SR of one 's own performance ( five 1-h sessions ) .


Patients in the control intervention practiced the same daily tasks with a therapist 's demonstration and guidance .


Performance of tasks , including household and monetary transaction tasks ; FIM ; Fugl-Meyer Assessment ( FMA ) ; and Color Trails Test ( CTT ) .


The SR group showed significant improvement in all tasks ( median difference , 1-2 ; effect size [ r ] = .74 -.89 ) versus none ( median difference , 0-0 .5 ) in the control group .


Results of the FIM ( P < .001 , r = .87 in the motor subscale ; P < .001 , r = .49 in the cognitive subscale ) , FMA ( P < .001 , r = .84 for upper extremity motor function and r = .63 for lower extremity motor function ) , and CTT ( P = .002 , r = .72 ) of the SR group improved .


The SR group outperformed their control counterparts in 4 of the 5 tasks ( median difference , 1 ; r = .30 -.52 ) and in the FIM motor subscale ( P = .002 , r = .47 ) , but not in the cognitive subscale and motor and cognitive functions .


SR appears useful for improving task performance that demands both motor and cognitive abilities by promoting information processing and active learning .


Tofacitinib is a novel , oral Janus kinase inhibitor currently under investigation for plaque psoriasis .


This exploratory analysis of a Phase IIb , 12-week , dose-ranging study ( clinicaltrials.gov identifier : NCT00678210 ) evaluated tofacitinib efficacy in four body regions of patients with moderate-to-severe chronic plaque psoriasis .


Patients ( n = 197 ) were randomized to tofacitinib 2 , 5 , or 15 mg , or placebo , twice daily ( BID ) .


Psoriasis Area and Severity Index ( PASI ) score , body surface area values and change from baseline to week 12 were measured according to body region ( head/neck , upper limbs , trunk and lower limbs ) .


Change in Target Plaque Severity Score ( TPSS ) from baseline to week 12 was measured according to typically responsive as well as non-responsive treatment areas .


At week 12 , mean improvements in PASI and body surface area values were significantly greater with tofacitinib doses vs placebo across all four body regions measured ( P < 0.0001 ) .


TPSS in responsive areas decreased ( improved ) with tofacitinib 2 , 5 , and 15 mg BID vs placebo : -4.35 , -4.79 and -6.32 , vs -2.06 , respectively ( P < 0.0001 ) .


In non-responsive areas , TPSS decreased with tofacitinib 2 , 5 , and 15 mg BID vs placebo : -3.74 , -4.60 and -6.15 , vs -2.23 , respectively ( P < 0.01 ) .


Short-term ( 12-week ) treatment with oral tofacitinib produced clinical improvement across all body regions assessed in patients with moderate-to-severe plaque psoriasis , including areas typically non-responsive to treatment .


Exercise training improves physical fitness , insulin resistance , and endothelial function in type 2 diabetes .


Hypoxia may further optimize these beneficial effects .


The aim of this study was to compare the effects of hypoxic versus normoxic exercise training on physical fitness , endothelial function , and insulin resistance in type 2 diabetes .


Peak oxygen consumption , flow mediated dilation ( endothelial function ) , and glucose homeostasis were assessed in 19 patients ( 557 years ) before and after an 8-week intervention .


Subjects were randomly allocated to normoxic ( 21 % O2 , n = 9 ) or hypoxic ( 16.5 % O2 , n = 10 ) exercise training .


Endothelium-independent dilation was examined using sublingual administration of glyceryl trinitrate , and used to calculate the ratio between endothelium-dependent and - independent dilation .


Exercise training improved physical fitness and brachial artery ratio between endothelium-dependent and - independent dilation ( both p < 0.05 ) , whilst these exercise training-induced changes were similar in both groups ( interaction-effects p > 0.05 ) .


Exercise training did not significantly change brachial artery flow-mediated dilation or glyceryl trinitrate-response , superficial femoral artery flow-mediated dilation , or glucose homeostasis , whilst hypoxia did not alter the impact of exercise training .


Contrary to our hypothesis , hypoxia does not potentiate the effect of exercise training on physical fitness , vascular function , or glucose homeostasis in type 2 diabetes .


The effect of neighborhood and healthcare access factors on cancer outcomes among patients enrolled in navigator programs is not clearly understood .


This study assessed associations between : ( i ) neighborhood factors and diagnostic time to resolution ( TTR ) and ( ii ) geographic access and TTR following an abnormal breast or cervical cancer screening test among women participating in the Ohio Patient Navigator Research Program ( OPNRP ) .


Patient ( demographic , socioeconomic status , home-to-clinic distance ) and neighborhood ( deprivation , racial segregation ) characteristics of 801 women living in one of 285 census tracts ( CT ) in greater Columbus , Ohio were examined .


Randomization to receive navigation occurred at the clinic level .


Multilevel Cox regression and spatial analysis were used to estimate effects of various factors on TTR and assess model assumptions , respectively .


TTR increased as neighborhood deprivation increased .


After adjustment for age , friend social support , education , and healthcare status , the TTR among women living in a neighborhood with a moderate median household income ( between $ 36,147 and $ 53,099 ) was shorter compared with women living in low median household income neighborhoods ( < $ 36,147 ; P < 0.05 ) .


There is little evidence that unmeasured confounders are geographically patterned .


Increased neighborhood socioeconomic deprivation was associated with longer TTR following an abnormal breast or cervical cancer screening test .


These results highlight the need for addressing patient - and neighborhood-level factors to reduce cancer disparities among underserved populations .


Hypoxemia is a surrogate marker for periprocedural endoscopic complications .


There are no data comparing the safety of propofol sedation with another sedative regimen in medical thoracoscopy .


To evaluate whether sedation with propofol is as safe and effective as sedation with midazolam .


Ninety consecutive patients undergoing medical thoracoscopy were randomly allocated to receive either intravenous propofol or midazolam .


Predefined periprocedural complications included hypoxemia , hypotension , bleeding , need for airway insertion , mechanical ventilation , intensive care unit transfer and death .


The primary endpoint was the mean lowest oxygen saturation during the procedure .


Randomized groups had similar demographics ( 64 16 years , 57 % male , 91 % American Society of Anesthesiologists class III-IV ) and a balanced distribution of procedures .


The mean lowest oxygen saturation during the procedure was significantly lower in the propofol group as compared to the midazolam group ( 93 6 vs. 96 3 % , p = 0.007 ) .


Patients randomized to propofol showed more episodes of hypoxemia ( 27 vs. 4 % , p = 0.007 ) and hypotension ( 82 vs. 40 % , p < 0.0001 ) .


No procedure had to be aborted .


None of the patients required an artificial airway , mechanical ventilation or intensive care unit care , and none died .


As assessed by the surrogate marker hypoxemia , propofol should not be considered the first choice for sedation in medical thoracoscopy .


Given that the observed prevalence and time course of critical illness-related corticosteroid insufficiency ( CIRCI ) remain inconsistent in trauma patients , the present study was designed to investigate the prevalence , time course , and effect of CIRCI on the outcome of critically ill patients with multiple injuries .


In this multicenter , prospective cohort study , patients with multiple injuries in seven intensive care units in China were enrolled .


Adrenocorticotropic hormone ( ACTH ) stimulation tests were performed by administering intravenously 250 g of synthetic ACTH on Days 1 , 2 , 3 , 5 , and 7 after traumatic injury .


CIRCI was defined as baseline cortisol level of less than 10 g/dL or a cortisol ( difference baseline and highest cortisol level at 30 or 60 minutes after ACTH stimulation ) less than 9 g/dL .


The incidence and time course of CIRCI and 28-day mortality were recorded .


CIRCI occurred in 54.3 % ( 38 of 70 ) of the patients with multiple injuries , including 10 patients with total cortisol level of less than 10 g/dL and 28 patients with cortisol of less than 9 g/dL .


Most ( 94.7 % ) diagnosis of CIRCI was made in the first 48 hours after traumatic injury .


The CIRCI patients had significantly more severe illness on the day of admission .


At each time point , the baseline cortisol level was comparable between the CIRCI and non-CIRCI patients , while cortisol in the CIRCI group was significantly lower compared with the non-CIRCI group .


The CIRCI patients with a cortisol of less than 9 g/dL had a significantly higher 28-day mortality ( 39.3 % ) compared with those with a baseline cortisol level of less than 10 g/dL ( 10.0 % ) and non-CIRCI patients ( 6.3 % ) .


Only cortisol of less than 9 g/dL but not baseline cortisol level of less than 10 g/dL seemed to be an independent risk factor for death ( odds ratio , 1.19 ; p = 0.023 ) .


CIRCI is common in critically ill trauma population and usually occurs in the early stages .


Only the results of the ACTH stimulation test but not baseline cortisol level was associated with poor prognosis .


Prognostic study , level II .


To test a pathway through which a tailored , pain management education-coaching intervention could contribute to better cancer pain control through the effects of patients ' communication about pain on physician prescribing of pain medication .


Secondary analysis of data from a randomized controlled trial that tested the effects of a tailored education-coaching intervention on pain control for patients with advanced cancer .


The current analysis focused on a subset of the patients ( n = 135 ) who agreed to have their consultations audio-recorded .


Patients ' active communication about pain ( e.g. , expressing questions , concerns , and preferences about pain-related issues ) was coded from audio-recordings .


Change in pain medication was measured by patient self-report .


Improvement in pain control was scored as the difference between baseline pain score and pain reported at 6 weeks .


Patients ' pain-related communication was a significant predictor of patient-reported changes in physician prescribing of pain medication ( p < .0001 ) and mediated the effect of baseline pain on medication change .


Other predictors of change in pain medication were age ( younger ) and having participated in the intervention ( as opposed to usual care ) .


Of the patients reporting adjustment in pain medications , 49 % experienced better pain control compared with only 27 % of patients reporting no change in pain management ( p < .02 ) .


Cancer patients who ask questions , express concerns , and state preferences about pain-related matters can prompt physicians to change their pain management regimen , which in turn may lead to better pain control .


Future research should model pathways through which clinician-patient communication can lead to better cancer outcomes .


Daily life movements require balance ability .


Good balance control is closely related to body stability and its development .


Therefore , balance training is necessary for any age group .


This study proposes the combination of Kinect and virtual reality to build an information platform of interactive scenarios , for practice and evaluation of balance ability .


Real-time monitoring of SpO <formula> _ 2 </formula> , pulse rate , velocity and reaction time during the training process is presented for the training activities of elderly physical function .


Based on the indicators of balance ability , this information platform sets out various training activities to improve balance ability , making the supposedly tedious process fun and vivid and leading to much better training results .


The data ( SpO <formula> _ 2 </formula> , pulse rate , velocity , reaction time ) collected from this platform can be sorted and analysed , and the results used to evaluate the performance of balance training , and referenced for follow-up planning in the future .


The real-time pulse rate and SpO <formula> _ 2 </formula> measurement information indicating the training activities for the elderly to maintain physical function has a positive significance .


A noninvasive and unconstrained real-time method to detect the pulse rate and SpO <formula> _ 2 </formula> during exercises is presented .


The results of balance assessment scale testing of BBS and TUG for the experimental group show that effective balance really improved .


The difference between the experimental group and the control group was achieved by using paired t-test .


The data were analysed by the descriptive statistics on significant level of P < 0.01 .


From the training results of the participants , we know that the information platform developed for enhancing balance ability is in line with practical needs .


Furthermore , the fun and interesting game-like exercises it introduces are very helpful in improving balance ability , and certainly in preventing falls .


The primary purpose of the study was to determine whether Multisystemic Therapy adapted for health care settings ( MST-HC ) improved asthma management and health outcomes in high-risk African American adolescents with asthma .


Eligibility included self-reported African American ethnicity , ages 12 to 16 , moderate to severe asthma , and an inpatient hospitalization or at least 2 emergency department visits for asthma in the last 12 months .


Adolescents and their families ( N = 170 ) were randomized to MST-HC or in-home family support .


Data were collected at baseline and posttreatment ( 7 months ) based on an asthma management interview , medication adherence phone diary , and lung function biomarker ( forced expiratory volume in 1 s [ FEV1 ] ) .


Analyses were conducted using linear mixed modeling for continuous outcomes and generalized linear mixed modeling for binary outcomes .


In intent-to-treat analyses , adolescents randomized to MST-HC were more likely to improve on 2 of the measures of medication adherence and FEV1 .


Per-protocol analysis demonstrated that MST-HC had a medium effect on adherence measures and had a small to medium effect on lung function and the adolescent 's response to asthma exacerbations .


There are few interventions that have been shown to successfully improve asthma management in minority youth at highest risk for poor morbidity and mortality .


MST , a home-based psychotherapy originally developed to target behavior problems in youth , improved asthma management and lung function compared to a strong comparison condition .


Further follow-up is necessary to determine whether MST-HC reduces health care utilization accounting for seasonal variability .


A limitation to the study is that a greater number of participants in the control group came from single-parent families than in the MST group .


Icosapent ethyl ( IPE ) is a high-purity prescription form of eicosapentaenoic acid ( EPA ) ethyl ester approved to reduce triglyceride levels in patients with severe ( 5.65 mmol/L ) hypertriglyceridemia .


EPA , the active metabolite of IPE , is mainly metabolized via - oxidation , and studies suggest that omega-3 fatty acids such as EPA may have antithrombotic effects .


The objective of this study was to evaluate the effect of IPE on the pharmacokinetic and anticoagulation pharmacodynamics of warfarin , a substrate of cytochrome P450 2C9-mediated metabolism .


Healthy adults received oral warfarin ( 25 mg ) on day 1 , oral IPE ( 4 g/day ) on days 8-35 , and co-administration on Day 29 .


Primary pharmacokinetic end points were area under the concentration-versus-time curve from zero to infinity ( AUC ( 0 - ) ) and maximum plasma concentration ( C ( max ) ) for R - and S-warfarin ; pharmacodynamic end points were area under the international normalized ratio ( INR ) effect-time curve after the warfarin dose ( AUC ( INR ) ) and maximum INR ( INR ( max ) ) .


Twenty-five subjects completed the study .


AUC ( 0 - ) and C max ratios of geometric means for both R - and S-warfarin following co-administration of warfarin with versus without IPE were within the 90 % confidence intervals of 0.80-1 .25 .


AUC ( INR ) , INR ( max ) , and ratios were also similar .


IPE 4 g/day did not significantly change the single-dose AUC ( 0 - ) or C ( max ) of R - and S-warfarin or the anticoagulation pharmacodynamics of warfarin when co-administered as racemic warfarin at 25 mg .


Co-administration of these drugs was safe and well tolerated in this study of healthy adult subjects .


The publication of protocols by medical journals is increasingly becoming an accepted means for promoting good quality research and maximising transparency .


Recently , Finfer and Bellomo have suggested the publication of statistical analysis plans ( SAPs ) .


The aim of this paper is to make public and to report in detail the planned analyses that were approved by the Trial Steering Committee in May 2010 for the principal papers of the PACE ( Pacing , graded Activity , and Cognitive behaviour therapy : a randomised Evaluation ) trial , a treatment trial for chronic fatigue syndrome .


It illustrates planned analyses of a complex intervention trial that allows for the impact of clustering by care providers , where multiple care-providers are present for each patient in some but not all arms of the trial .


The trial design , objectives and data collection are reported .


Considerations relating to blinding , samples , adherence to the protocol , stratification , centre and other clustering effects , missing data , multiplicity and compliance are described .


Descriptive , interim and final analyses of the primary and secondary outcomes are then outlined .


This SAP maximises transparency , providing a record of all planned analyses , and it may be a resource for those who are developing SAPs , acting as an illustrative example for teaching and methodological research .


It is not the sum of the statistical analysis sections of the principal papers , being completed well before individual papers were drafted .


ISRCTN54285094 assigned 22 May 2003 ; First participant was randomised on 18 March 2005 .


The purpose of this study was to evaluate the efficacy of a self-guided CD-ROM program ( `` Headstrong '' ) containing cognitive-behavioral self-management strategies versus an educational CD-ROM program for treating headaches , headache-related disability , and quality of life .


Participants were 35 children ages 7-12years with migraine recruited from one university medical center and two children 's hospital headache clinics .


Participants were randomly assigned to complete the Headstrong or educational control CD-ROM program over a 4-week period .


Data on headache frequency , duration , and severity , migraine-related disability , and quality of life ( QOL ) were obtained at baseline , post-intervention , and 3-months post-intervention .


At post-intervention , Headstrong resulted in lower severity ( on a 10-point scale ) than the control group by child report ( 5.061.50 SD vs. 6.251.92 SD , p = 0.03 , ES = 0.7 ) .


At 3-months post-intervention , parents reported less migraine-related disability ( on the PedMIDAS ) in the Headstrong group compared to the control group ( 1.362.06 SD vs. 5.186.40 SD ; p = 0.04 , ES = 0.8 ) .


There were no other group differences at post treatment or at 3-months post-intervention .


When compared to an educational control , Headstrong resulted in lower pain severity at post-treatment and less migraine-related disability at 3-months post-intervention , by child and parent report respectively .


Headache frequency and quality of life did not change more for Headstrong versus control .


Additional research is needed on the Headstrong Program to increase its efficacy and to test it with a larger sample recruited from multiple centers simultaneously .


Vaccines may have non-specific effects .


An observational study from Guinea-Bissau suggested that oral polio vaccine at birth ( OPV0 ) provided with Bacillus Calmette-Gurin ( BCG ) vaccine was associated with down-regulation of the immune response to BCG vaccine 6 weeks later .


Based on the previous finding , we wanted to test our a priori hypothesis that OPV would dampen the immune response to BCG , and secondarily to test immune responses to other antigens .


The study was conducted at the Bandim Health Project in Guinea-Bissau in 2009-2010 .


Infants were randomised to OPV0 + BCG versus BCG alone at birth , and subsequently randomised to have a blood sample taken at 2 , 4 or 6 weeks post-randomisation .


Excreted levels of cytokines ( IL-2 , IL-5 , IL-10 , TNF - and IFN - ) were measured from whole blood in vitro stimulations with a panel of recall vaccine antigens ( BCG , PPD , OPV ) , mitogen ( PHA ) or innate agonists ( LPS , Pam3cys , PolyI : C ) .


Additionally , we measured the local reaction to BCG , white blood cell distribution , C-reactive protein ( CRP ) and retinol-binding protein ( RBP ) .


Cytokine production was analysed as the prevalence ratios of responders above the median .


Blood samples from 430 infants ( 209 OPV0 + BCG ; 221 BCG alone ) were analysed .


There were no strong differences in effects 2 , 4 and 6 weeks post-randomisation and subsequent analyses were performed on the pooled data .


As hypothesised , receiving OPV0 + BCG versus BCG alone was associated with significantly lower prevalence of IFN - responses to PPD ( prevalence ratio ( PR ) : 0.84 ( 0.72-0 .98 ) ) and reduced IL-5 to PPD ( PR : 0.78 ( 0.64-0 .96 ) ) .


No effects were observed for CPR , RBP , white blood cell distribution , or BCG scar prevalence .


The results corroborate that OPV attenuates the immune response to co-administered BCG at birth .


To investigate the effects of a low fermentable , oligosaccharides , disaccharides , monosaccharides and polyols diet ( LFD ) and the probiotic Lactobacillus rhamnosus GG ( LGG ) in irritable bowel syndrome ( IBS ) .


Randomised , unblinded controlled trial on the effect of 6-wk treatment with LFD , LGG or a normal Danish/Western diet ( ND ) in patients with IBS fulfilling Rome III diagnostic criteria , recruited between November 2009 and April 2013 .


Patients were required to complete on a weekly basis the IBS severity score system ( IBS-SSS ) and IBS quality of life ( IBS-QOL ) questionnaires in a specially developed IBS web self-monitoring application .


We investigated whether LFD or LGG could reduce IBS-SSS and improve QOL in IBS patients .


One hundred twenty-three patients ( median age 37 years , range : 18-74 years ) , 90 ( 73 % ) females were randomised : 42 to LFD , 41 to LGG and 40 to ND .


A significant reduction in mean SD of IBS-SSS from baseline to week 6 between LFD vs LGG vs ND was revealed : 133 122 vs 68 107 , 133 122 vs 34 95 , P < 0.01 .


Adjusted changes of IBS-SSS for baseline covariates showed statistically significant reduction of IBS-SSS in LFD group compared to ND ( IBS-SSS score 75 ; 95 % CI : 24-126 , P < 0.01 ) , but not in LGG compared to ND ( IBS-SSS score 32 ; 95 % CI : 18-80 , P = 0.20 ) .


IBS-QOL was not altered significantly in any of the three groups : mean SD in LFD 8 18 vs LGG 7 17 , LFD 8 18 vs ND 0.1 15 , P = 0.13 .


Both LFD and LGG are efficatious in patients with IBS .


To determine the efficacy of the Airtraq versus the McCoy laryngoscope as intubation devices with the neck stabilized by a rigid cervical collar .


Prospective , randomized , double-blinded study .


Jawaharlal Nehru Medical College .


60 ASA physical status 1 , 2 , and 3 patients , aged 18-70 years , scheduled for various surgical procedures requiring tracheal intubation for surgical anesthesia .


Patients were randomly allocated to undergo intubation with the McCoy ( n = 30 ) or Airtraq ( n = 30 ) laryngoscope .


Differences in intubation times between the Airtraq and the McCoy laryngoscope , modified Cormack-Lehane score , percentage of glottic opening ( POGO ) score , and airway trauma were compared .


Overall intubation success rates were 100 % with both devices and a similar number of intubation attempts were required .


However , the mean ( SD ) time required for successful intubation was shorter with the Airtraq ( 28.73 6.39 sec ) than the McCoy laryngoscope ( 39.11 14.01 sec ; P < 0.0001 ) .


The frequencies of intubation complications were similar .


Esophageal intubation occurred in 4 cases but only with the McCoy laryngoscope .


Intubation time was shorter with the Airtraq than the McCoy laryngoscope , even though the overall success rates between the two devices were similar .


Physicians may be important sources of sexuality information and preventive services , and one-on-one confidential time during health maintenance visits is recommended to allow discussions of sexual development , behavior , and risk reduction .


However , little is known about the occurrence and characteristics of physician-adolescent discussions about sexuality .


To examine predictors of time spent discussing sexuality , level of adolescent participation , and physician and patient characteristics associated with sexuality discussions during health maintenance visits by early and middle adolescents .


Observational study of audio-recorded conversations between 253 adolescents ( mean age , 14.3 years ; 53 % female ; 40 % white ; 47 % African American ) and 49 physicians ( 82 % pediatricians ; 84 % white ; 65 % female ; mean age , 40.9 years ; mean [ SD ] duration in practice , 11.8 [ 8.7 ] years ) coded for sexuality content at 11 clinics ( 3 academic and 8 community-based practices ) located throughout the Raleigh/Durham , North Carolina , area .


Total time per visit during which sexuality issues were discussed .


RESULTS One hundred sixty-five ( 65 % ) of all visits had some sexual content within it .


The average time of sexuality talk was 36 seconds ( 35 % 0 seconds ; 30 % 1-35 seconds ; and 35 % 36 seconds ) .


Ordinal logistic regression ( outcome of duration : 0 , 1-35 , or 36 seconds ) , adjusted for clustering of patients within physicians , found that female patients ( odds ratio [ OR ] = 2.58 ; 95 % CI , 1.53-4 .36 ) , older patients ( OR = 1.37 ; 95 % CI , 1.13-1 .65 ) , conversations with explicit confidentiality discussions ( OR = 4.33 ; 95 % CI , 2.58-7 .28 ) , African American adolescents ( OR = 1.58 ; 95 % CI , 1.01-2 .48 ) , and longer overall visit ( OR = 1.07 ; 95 % CI , 1.03-1 .11 ) were associated with more sexuality talk , and Asian physicians were associated with less sexuality talk ( OR = 0.13 ; 95 % CI , 0.08-0 .20 ) .


In addition , the same significant associations between adolescent , physician , and visit characteristics were significantly associated with greater adolescent participation .


Our study may be the first to directly observe sexuality talk between physicians and adolescents .


We found that one-third of all adolescents had annual visits without any mention of sexuality issues ; when sexuality talk occurred , it was brief .


Research is needed to identify successful strategies physicians can use to engage adolescents in discussions about sexuality to help promote healthy sexual development and decision making .


clinicaltrials.gov Identifier : NCT01040975 .


To assess the effectiveness of an integrated early child development intervention , combining stimulation and micronutrient supplementation and delivered on a large scale in Colombia , for children 's development , growth , and hemoglobin levels .


Cluster randomized controlled trial , using a 2 2 factorial design , with municipalities assigned to one of four groups : psychosocial stimulation , micronutrient supplementation , combined intervention , or control .


96 municipalities in Colombia , located across eight of its 32 departments .


1420 children aged 12-24 months and their primary carers .


Psychosocial stimulation ( weekly home visits with play demonstrations ) , micronutrient sprinkles given daily , and both combined .


All delivered by female community leaders for 18 months .


Cognitive , receptive and expressive language , and fine and gross motor scores on the Bayley scales of infant development-III ; height , weight , and hemoglobin levels measured at the baseline and end of intervention .


Stimulation improved cognitive scores ( adjusted for age , sex , testers , and baseline levels of outcomes ) by 0.26 of a standard deviation ( P = 0.002 ) .


Stimulation also increased receptive language by 0.22 of a standard deviation ( P = 0.032 ) .


Micronutrient supplementation had no significant effect on any outcome and there was no interaction between the interventions .


No intervention affected height , weight , or hemoglobin levels .


Using the infrastructure of a national welfare program we implemented the integrated early child development intervention on a large scale and showed its potential for improving children 's cognitive development .


We found no effect of supplementation on developmental or health outcomes .


Moreover , supplementation did not interact with stimulation .


The implementation model for delivering stimulation suggests that it may serve as a promising blueprint for future policy on early childhood development.Trial registration Current Controlled trials ISRCTN18991160 .


To study the influence of acupuncture at Waiguan ( TE5 ) on the functional connectivity of the central nervous system of patients with ischemic stroke .


Twenty-four patients with ischemic stroke in the left basal ganglia were randomized based on gender to receive TE5 acupuncture ( n = 12 ) or nonacupoint acupuncture ( n = 12 ) .


Each group underwent sham acupuncture and then verum acupuncture while being scanned with functional magnetic resonance imaging .


Six regions of interest ( ROI ) were defined , including bilateral motor , somatosensory , and bilateral basal ganglia areas .


The functional connectivity between these ROIs and all voxels of the brain was analyzed in Analysis of Functional NeuroImages ( AFNI ) to explore the differences between verum acupuncture and sham acupuncture at TE5 and between TE5 acupuncture and nonacupoint acupuncture .


The participants were blinded to the allocation .


The effect of acupuncture on six seed-associated networks was explored .


The result demonstrated that acupuncture at Waiguan ( TE5 ) can regulate the sensorimotor network of the ipsilesional hemisphere , stimulate the contralesional sensorimotor network , increase cooperation of bilateral sensorimotor networks , and change the synchronization between the cerebellum and cerebrum .


Furthermore , a lot of differences of effect existed between verum acupuncture and sham acupuncture at TE5 , but there was little difference between TE5 acupuncture and nonacupoint acupuncture .


The modulation of synchronizations between different regions within different brain networks might be the mechanism of acupuncture at Waiguan ( TE5 ) .


Stimulation of the contralesional sensorimotor network and increase of cooperation of bilateral hemispheres imply a compensatory effect of the intact hemisphere , whereas changes in synchronization might influence the sensorimotor function of the affected side of the body .


Chinese Clinical Trial Registry ChiCTR-ONRC-08000255 .


Severe acute pancreatitis is still a potentially life threatening disease with high mortality .


The aim of this study was to evaluate the therapeutic effect of thoracic epidural anaesthesia ( TEA ) on survival , microcirculation , tissue oxygenation and histopathologic damage in an experimental animal model of severe acute pancreatitis in a prospective animal study .


In this study , 34 pigs were randomly assigned into 2 treatment groups .


After severe acute pancreatitis was induced by intraductal injection of glycodesoxycholic acid in Group 1 ( n = 17 ) bupivacaine ( 0.5 % ; bolus injection 2ml , continuous infusion 4ml/h ) was applied via TEA .


In Group 2 ( n = 17 ) no TEA was applied .


During a period of 6hours after induction , tissue oxygen tension ( tpO2 ) in the pancreas and pancreatic microcirculation was assessed .


Thereafter animals were observed for 7days followed by sacrification and histopathologic examination .


Survival rate after 7days was 82 % in Group 1 ( TEA ) versus 29 % in Group 2 : ( Control ) ( P < 0.05 ) .


Group 1 ( TEA ) also showed a significantly superior microcirculation ( 1,608374 AU versus 1,121510 AU ; P < 0.05 ) and tissue oxygenation ( 21564mmHg versus 13890 mmHG ; P < 0.05 ) as compared to Group 2 ( Control ) .


Consecutively , tissue damage in Group 1 was reduced in the histopathologic scoring ( 5.5 ( 3 to 8 ) versus 8 ( 5.5 to 10 ) ; P < 0.05 ) .


TEA led to improved survival , enhanced microcirculatory perfusion and tissue oxygenation and resulted in less histopathologic tissue-damage in an experimental animal model of severe acute pancreatitis .


Persistent atrial fibrillation frequently shows multiple different electrophysiological mechanisms of induction .


This heterogeneity causes a low success rate of single procedures of ablation and a high incidence of recurrence .


Surgical ablation through bilateral thoracotomy demonstrates better results after a single procedure .


Prospective observational studies in inhomogeneous populations without control groups report a remarkable 90 % of success with hybrid or staged procedures of surgical ablation coupled with catheter ablation .


In this trial , we will examine the hypothesis that a staged approach involving initial minimally invasive surgical ablation of persistent atrial fibrillation , followed by a second percutaneous procedure in case of recurrence , has a higher success rate than repeated percutaneous procedures .


This is a controlled ( 2:1 ) randomized trial comparing use of a percutaneous catheter with minimally invasive transthoracic surgical ablation of persistent atrial fibrillation .


The inclusion and exclusion criteria , definitions , and treatment protocols are those reported by the 2012 Expert Consensus Statement on catheter and surgical ablation of atrial fibrillation .


Patients will be randomized to either percutaneous catheter ( n = 100 ) or surgical ( n = 50 ) ablation as the first procedure .


After 3 months , they are re-evaluated , according to the same guidelines , and receive a second procedure if necessary .


Crossover will be allowed and data analyzed on an `` intention-to-treat '' basis .


Primary outcomes are the incidence of sinus rhythm at 6 and 12 months and the proportions of patients requiring a second procedure .


The use of a staged strategy combining surgical and percutaneous approaches might be more favorable in treatment of persistent atrial fibrillation than the controversial single percutaneous ablation .


ISRCTN08035058 Reg 06.20.2013 .


Postconditioning has been reported to reduce infarct size in ST-segment myocardial infarction ( STEMI ) .


However , recently , few other studies did not show any effect of postconditioning and suggested that it may be even harmful .


We sought to assess whether postconditioning could reduce infarct size and improve myocardial reperfusion in early presenters with STEMI .


72 STEMI patients treated with primary percutaneous coronary intervention ( PCI ) were randomly assigned to either the postconditioning ( n = 35 ) or the standard PCI group ( control group ; n = 37 ) .


Blood samples were obtained for creatine kinase ( CK ) and its MB isoform ( CK-MB ) within 36 h.


The angiographic ( myocardial blush grade , MBG ) and electrocardiographic ( ST-segment resolution , STR ) data were evaluated and compared between groups .


The areas under the curve of CK and CK-MB release were significantly reduced in the postconditioning group compared with the control group ( 38,612.91 25,028.42 vs. 60,547.30 25,264.63 for CK and 5,498.23 3,787.91 vs. 7,443.12 3,561.13 for CK-MB , p < 0.0001 ) .


MBG was significantly better in the postconditioning group than in the control group ( MBG 3 : 82.3 vs. 47.1 % , p = 0.0023 ) .


In the postconditioning group , STR > 70 % was more often observed ( 97.1 vs. 64.1 % , p = 0.0007 ) .


In patients with STEMI , postconditioning could significantly reduce enzymatic infarct size and improve myocardial reperfusion .


There are several therapies for treating lupoid leishmaniasis .


We compared the effectiveness of intralesional meglumine antimoniate ( MA ) and topical application of trichloroacetic acid ( TCA ) 50 % solution .


This study was a randomized clinical trial comprising 60 lupoid leishmaniasis patients .


The first group received intralesional MA once a week , and the second group was treated once weekly with TCA 50 % topical solution .


The results were recorded once after 8 weeks and then 3 months after the termination of treatment .


The total clearance rates after treatment and after the 3-month follow-up were , respectively , 48.1 % and 40 % in the first group and 44.4 % and 36.6 % in the second group .


There was no significant difference between the two treatment groups ( p = .25 and p = .26 ) .


In both groups , the most common side effect was scarring .


Having almost the same efficacies , TCA as a topical approach could be as effective as MA in the lupoid leishmaniasis treatment plan .


The World Health Organization recommends the use of syndromic management for patients presenting with genital ulcer disease ( GUD ) in developing countries .


However , effective treatment guidelines depend on a current country-specific GUD etiological profile , which may change over time .


From 2004 to 2006 , we conducted a cross-sectional analysis of baseline data from patients presenting with GUD at a reference STI clinic in Lilongwe , Malawi .


Participants were enrolled in a randomized clinical trial of acyclovir added to syndromic management and followed up for up to 28 days .


Serologies for HIV ( using parallel rapid tests ) , herpes simplex virus type 2 ( HSV-2 ; using Focus HerpeSelect IgG2 ELISA [ Focus Technologies , Cypress Hill , CA ] ) , and syphilis ( rapid plasma reagin confirmed by Treponema pallidum hemagglutination ) were determined , with plasma HIV-1 RNA and CD4 count in HIV-positive patients .


Genital ulcer disease etiology was determined by real-time multiplex polymerase chain reaction from lesional swabs .


A total of 422 patients with GUD ( 313 men ; 74 % ) were enrolled .


Overall seroprevalence of HIV-1 , HSV-2 , and syphilis were 61 % , 72 % , and 5 % , respectively .


Ulcer etiology was available for 398 patients and showed the following : HSV-2 , 67 % ; Haemophilus ducreyi , 15 % ; T. pallidum , 6 % ; lymphogranuloma venereum , 6 % ; mixed infections , 14 % , and no etiology , 20 % .


Most HSV-2 ulcers were recurrent ( 75 % ) .


Among all patients with HSV-2 , HIV prevalence was high ( 67 % ) and HIV seroprevalence was higher among patients with recurrent HSV-2 compared with patients with first-episode HSV-2 ( 78 % vs. 39 % , P < 0.001 ) .


Herpes simplex virus type 2 ulcers are highly prevalent in this symptomatic population and strongly associated with HIV .


Unlike most locations in sub-Saharan Africa , H. ducreyi remains prevalent in this population and requires periodic monitoring and an appropriate treatment regimen .


The basic difference between the various common medical laser systems is the wavelength of the emitted light , leading to altered light-tissue interactions due to the optical parameters of the tissue .


This study examines laser induced tissue effects in an in vitro tissue model using 1,470 nm diode laser compared to our standard practice for endonasal applications ( 940nm diode laser ) under standardised and reproducible conditions .


Additionally , in vivo induced tissue effects following non-contact application with focus on mucosal healing were investigated in a controlled intra-individual design in patients treated for hypertrophy of nasal turbinate .


A certified diode laser system emitting the light of = 1470nm was evaluated with regards to its tissue effects ( ablation , coagulation ) in an in vitro setup on porcine liver and turkey muscle tissue model .


To achieve comparable macroscopic tissue effects the laser fibres ( 600m core diameter ) were fixed to a computer controlled stepper motor and the laser light was applied in a reproducible procedure under constant conditions .


For the in vivo evaluation , 20 patients with nasal obstruction due to hyperplasia of inferior nasal turbinates were included in this prospective randomised double-blinded comparative trial .


The endoscopic controlled endonasal application of = 1470nm on the one and = 940nm on the other side , both in ` non-contact ' mode , was carried out as an outpatient procedure under local anaesthesia .


The postoperative wound healing process ( mucosal swelling , scab formation , bleeding , infection ) was endoscopically documented and assessed by an independent physician .


In the experimental setup , the 1,470 nm laser diode system proved to be efficient in inducing tissue effects in non-contact mode with a reduced energy factor of 5-10 for highly perfused liver tissue to 10-20 for muscle tissue as compared to the 940nm diode laser system .


In the in vivo evaluation scab formation following laser surgery as assessed clinically on endonasal endoscopy was significantly reduced on 1,470 nm treated site compared to 940nm diode laser treated site .


Diode laser system ( 1,470 nm ) induces efficient tissue effects compared to 940nm diode laser system as shown in the tissue model experiment .


From the clinical point of view , the healing process following non-contact diode laser application revealed to be improved using 1,470 nm diode laser compared to our standard diode laser practise with 940nm .


Relapsed multiple myeloma has no standard treatment , and the role of autologous stem-cell transplantation ( ASCT ) has not been fully defined .


We aimed to compare high-dose melphalan plus salvage ASCT with cyclophosphamide in patients with relapsed multiple myeloma who had previously undergone ASCT .


This multicentre , randomised , open-label , phase 3 study recruited patients aged at least 18 years with multiple myeloma who needed treatment for first progressive or relapsed disease at least 18 months after a previous ASCT from 51 centres across the UK .


Before randomisation , eligible patients received bortezomib , doxorubicin , and dexamethasone ( PAD ) induction therapy and then underwent peripheral blood stem-cell mobilisation and harvesting if applicable .


Eligible patients ( with adequate stem-cell harvest ) were randomly assigned ( 1:1 ) , using an automated telephone randomisation line , to either high-dose melphalan 200 mg/m ( 2 ) plus salvage ASCT or oral cyclophosphamide ( 400mg/m ( 2 ) per week for 12 weeks ) .


Randomisation was stratified by length of first remission or plateau and response to PAD re-induction therapy .


The primary endpoint was time to disease progression , analysed by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT00747877 , and EudraCT , number 2006-005890-24 .


Between April 16 , 2008 , and Nov 19 , 2012 , 297 patients were registered , of whom 293 received PAD re-induction therapy .


Between Aug 26 , 2008 , and Nov 16 , 2012 , 174 patients with sufficient PBSCs were randomised to salvage ASCT ( n = 89 ) or cyclophosphamide ( n = 85 ) .


After a median follow-up of 31 months ( IQR 19-42 ) , median time to progression was significantly longer in the salvage ASCT than in the cyclophosphamide group ( 19 months [ 95 % CI 16-25 ] vs 11 months [ 9-12 ] ; hazard ratio 036 [ 95 % CI 025-053 ] ; p < 00001 ) .


Frequently reported ( in > 10 % of patients ) grade 3-4 adverse events with PAD induction , salvage ASCT , and cyclophosphamide were : neutropenia ( 125 [ 43 % ] of 293 patients after PAD , and 63 [ 76 % ] of 83 patients in the salvage ASCT group vs 11 [ 13 % ] of 84 patients in the cyclophosphamide group ) , thrombocytopenia ( 150 [ 51 % ] after PAD , and 60 [ 72 % ] vs four [ 5 % ] , respectively ) , and peripheral neuropathy ( 35 [ 12 % ] after PAD , and none vs none , respectively ) .


This study provides evidence for the improved efficacy of high-dose melphalan plus salvage ASCT when compared with cyclophosphamide in patients with relapsed multiple myeloma eligible for intensive therapy , which might help to guide clinical decisions regarding the management of such patients .


Cancer Research UK .


Laparoscopic skills training has evolved over recent years .


However , conveying a mentor 's directions using conventional methods , without realistic on-screen visual cues , can be difficult and confusing .


To facilitate laparoscopic skill transference , an augmented reality telementoring ( ART ) platform was designed to overlay the instruments of a mentor onto the trainee 's laparoscopic monitor .


The aim of this study was to compare the effectiveness of this new teaching modality to traditional methods in novices performing an intracorporeal suturing task .


Nineteen pre-medical and medical students were randomized into traditional mentoring ( n = 9 ) and ART ( n = 10 ) groups for a laparoscopic suturing and knot-tying task .


Subjects received either traditional mentoring or ART for 1 h on the validated fundamentals of laparoscopic surgery intracorporeal suturing task .


Tasks for suturing were recorded and scored for time and errors .


Results were analyzed using means , standard deviation , power regression analysis , correlation coefficient , analysis of variance , and student 's t test .


Using Wright 's cumulative average model ( Y = aX ( b ) ) the learning curve slope was significantly steeper , demonstrating faster skill acquisition , for the ART group ( b = -0.567 , r ( 2 ) = 0.92 ) than the control group ( b = -0.453 , r ( 2 ) = 0.74 ) .


At the end of 10 repetitions or 1 h of practice , the ART group was faster versus traditional ( mean 167.4 vs. 242.4 s , p = 0.014 ) .


The ART group also had fewer fails ( 8 ) than the traditional group ( 13 ) .


The ART Platform may be a more effective training technique in teaching laparoscopic skills to novices compared to traditional methods .


ART conferred a shorter learning curve , which was more pronounced in the first 4 trials .


ART reduced the number of failed attempts and resulted in faster suture times by the end of the training session .


ART may be a more effective training tool in laparoscopic surgical training for complex tasks than traditional methods .


This study compared the long-term efficacy of a diabetes-specific cognitive behavioral group therapy ( CBT ) with sertraline in patients with diabetes and depression who initially responded to short-term depression treatment .


A randomized controlled single-blind trial was conducted in 70 secondary care centers across Germany comparing 12 weeks of CBT with sertraline in 251 patients with type 1 or 2 diabetes ( mean HbA1c 9.3 % , 78 mmol/mol ) and major depression ( Structured Clinical Interview for DSM-IV [ SCID ] ) .


After 12 weeks , treatment responders ( 50 % reduction Hamilton Depression Rating Scale [ HAMD-17 ] ) were included in the 1-year study phase where CBT patients were encouraged to use bibliotherapy and sertraline patients received continuous treatment .


We analyzed differences for HbA1c ( primary outcome ) and reduction ( HAMD-17 ) or remission ( SCID ) of depression from baseline to the 1-year follow-up using ANCOVA or logistic regression analysis .


After 12 weeks , 45.8 % of patients responded to antidepressant treatment and were included in the 1-year study phase .


Adjusted HbA1c mean score changes from baseline to the end of the long-term phase ( -0.27 , 95 % CI -0.62 to 0.08 ) revealed no significant difference between interventions .


Depression improved in both groups , with a significant advantage for sertraline ( HAMD-17 change : -2.59 , 95 % CI 1.15-4 .04 , P < 0.05 ) .


Depression improved under CBT and sertraline in patients with diabetes and depression , with a significant advantage for sertraline , but glycemic control remained unchanged .


CBT and sertraline as single treatment are insufficient to treat secondary care diabetes patients with depression and poor glycemic control .


Standing invoked change in QT interval has been identified as a promising autonomic maneuver for the assessment of QT/QTc prolongation in patients with underlying heart abnormalities or as a positive control in healthy volunteers for drug studies .


Criticism for its more widespread use is the high variability in reported results and the need for a more standardized methodology with defined normal ranges .


Forty healthy male subjects underwent continuous ECG collection on the day before dosing in a double-blind , placebo-controlled , randomized , single ascending dose trial .


A brisk supine to standing ( 3 minutes ) response was conducted at three time points .


Results were grouped by treatment cohort or assessed as a pooled group at each time point .


Maximum time and median change from baseline ( Tmax QTcF , QTcF ) were calculated for each individual over sequential 30-second periods staggered by 5 seconds .


Maximum QTcF at all time points and in all groups was significant ( i.e. , the lower bound of 90 % CI was > 5 milliseconds ) which is the ICH E14 regulatory requirement for a positive control .


Variability of the time to maximum response was also reduced 9-fold by the third time period .


Standing invoked QTcF can be utilized to validate the sensitivity of a study for assessment of the QT interval effect of drugs in early development .


The methodology may be used to further improve its diagnostic use of long QT syndromes by reducing the variability and allowing adequate definition of normal limits .


The purpose of this study was to explore the effect of Lavandula angustifolia ( lavender ) inhalation on the symptoms of dysmenorrhea and the amount of menstrual bleeding in female students with primary dysmenorrhea .


This study is an experimental clinical trial .


The subjects were 96 female students residing in dormitory at Tehran University of Medical Sciences in 2011 and suffering from level two or three dysmenorrhea according to the verbal multi-dimensional scoring system .


The inclusion criteria were as : being single , suffering from primary dysmenorrhea , having no genital organs disorder , having no systemic disease , having regular menstrual cycles , using no contraceptives , etc. .


The follow-up time was 4 menstrual cycles .


The subjects were randomized into two groups : experimental ( n = 48 ) who inhaled lavender based on sesame oil , and placebo ( n = 48 ) who inhaled sesame oil only .


The severity of dysmenorrhea symptoms was measured through a questionnaire , and the amount of menstrual bleeding was measured by sanitary towel usage .


Ordinal logistic regression and generalized estimating equation ( GEE ) were used to analyze the data .


The symptoms of dysmenorrhea were significantly lowered in the lavender group compared to the placebo group ( p < 0.001 ) .


The amount of menstrual bleeding in the lavender group was reduced in comparison to the placebo group but the difference was not statistically significant ( p = 0.25 ) .


No significant difference was observed for blood clot among the students ( p = 0.666 ) .


This study showed that lavender inhalation was effective in alleviating dysmenorrhea symptoms , suggesting that it could be applied by midwives in a safe manner because of no side effects , simplicity and cost-effectiveness for all patients .


Ipilimumab is a fully human , monoclonal antibody that blocks cytotoxic T-lymphocyte antigen-4 .


The objective of the present study was to characterize the clinical pharmacology profile of ipilimumab using a population pharmacokinetic ( PPK ) approach .


The PPK model was developed using 2095 ipilimumab serum concentration values from 499 patients with unresectable stage III or IV melanoma from four phase II studies , with ipilimumab doses ranging from 0.3 to 10mgkg ( -1 ) .


The structural PK model was determined by developing a base PPK model .


The effect of covariates on model parameters was assessed by a full covariate model , which incorporated all pre-specified covariate-parameter relationships into the base model .


The final model was developed by backward elimination , followed by exclusion of covariates determined not to be of clinical relevance to ipilimumab , and was rigorously validated against both internal and external datasets .


Ipilimumab PK was linear and time-invariant , with dose-proportional exposures over the available dose range , yielding a terminal half-life of approximately 15 days .


Clearance of ipilimumab increased with increasing body weight and baseline serum lactate dehydrogenase concentrations , but was not affected by age , gender , concomitant budesonide , Eastern Cooperative Oncology Group performance status or prior systemic anticancer therapy .


Furthermore , ipilimumab exposure was not affected by moderate renal impairment or mild hepatic impairment .


Ipilimumab concentration-time data were well described by a linear , two compartment , zero order i.v. infusion model .


The model confirms that a body weight-normalized dosing regimen is appropriate for ipilimumab therapy in patients with advanced melanoma .


Optimal analgesia in ambulatory urology patients still remains a challenge .


The aim of this study was to examine if the pre-emptive use of intravenous tramadol can reduce pain after ureteroscopic lithotripsy in patients diagnosed with unilateral ureteral stones .


This prospective pilot cohort study included 74 patients diagnosed with unilateral ureteral stones who underwent ureteroscopic lithotripsy under general anesthesia in the Urology Clinic at the Clinical Center of Serbia from March to June 2012 .


All patients were randomly allocated to two groups : one group ( 38 patients ) received intravenous infusion of tramadol 100 mg in 500 mL 0.9 % NaCl one hour before the procedure , while the other group ( 36 patients ) received 500 mL 0.9 % NaCl at the same time .


Visual analogue scale ( VAS ) scores were recorded once prior to surgery and two times after the surgery ( 1 h and 6 h , respectively ) .


The patients were prescribed additional postoperative analgesia ( diclofenac 75 mg i.m. ) when required .


Pre-emptive effects of tramadol were assessed measuring pain scores , VAS1 and VAS2 , intraoperative fentanyl consumption , and postoperative analgesic requirement .


The average VAS1 score in the tramadol group was significantly lower than that in the non-tramadol group .


The difference in average VAS2 score values between the two groups was not statistically significant ; however , there were more patients who experienced severe pain in the non-tramadol group ( p < 0.01 ) .


The number of patients that required postoperative analgesia was not statistically different between the groups .


Pre-emptive tramadol did reduce early postoperative pain .


The patients who received pre-emptive tramadol were less likely to experience severe post-operative pain .


To investigate the effects of exenatide on blood glucose , body weight and hepatic enzymes in patients with type 2 diabetes mellitus ( T2DM ) and concomitant non-alcoholic fatty liver disease ( NAFLD ) .


One hundred and seventeen patients with T2DM and NAFLD were randomly divided into exenatide group and metformin group .


Patients were treated with exenatide and metformin , respectively , for 12 weeks .


After 12 weeks of treatment , body weight , body mass index ( BMI ) , waist-to-hip ratio , HbA1c , FPG , 2-h PPG , ALT , AST , - GT , and hs-CRP were significantly reduced , and the AST/ALT ratio and adiponectin were markedly increased in both groups .


BMI , waist-to-hip ratio , 2-h PPG , ALT , AST , - GT , and hs-CRP were markedly lower , and AST/ALT ratio and adiponectin in the exenatide group were dramatically higher than in the metformin group .


Compared with metformin , exenatide is better to control blood glucose , reduces body weight and improves hepatic enzymes , attenuating NAFLD in patients with T2DM concomitant with NAFLD .


Although previous studies have demonstrated that children with high levels of fundamental movement skill competency are more active throughout the day , little is known regarding children 's fundamental movement skill competency and their physical activity during key time periods of the school day ( i.e. , lunchtime , recess and after-school ) .


The purpose of this study was to examine the associations between fundamental movement skill competency and objectively measured moderate-to-vigorous physical activity ( MVPA ) throughout the school day among children attending primary schools in low-income communities .


Eight primary schools from low-income communities and 460 children ( 8.5 0.6 years , 54 % girls ) were involved in the study .


Children 's fundamental movement skill competency ( TGMD-2 ; 6 locomotor and 6 object-control skills ) , objectively measured physical activity ( ActiGraph GT3X and GT3X + accelerometers ) , height , weight and demographics were assessed .


Multilevel linear mixed models were used to assess the cross-sectional associations between fundamental movement skills and MVPA .


After adjusting for age , sex , BMI and socio-economic status , locomotor skill competency was positively associated with total ( P = 0.002 , r = 0.15 ) and after-school ( P = 0.014 , r = 0.13 ) MVPA .


Object-control skill competency was positively associated with total ( P < 0.001 , r = 0.20 ) , lunchtime ( P = 0.03 , r = 0.10 ) , recess ( P = 0.006 , r = 0.11 ) and after-school ( P = 0.022 , r = 0.13 ) MVPA .


Object-control skill competency appears to be a better predictor of children 's MVPA during school-based physical activity opportunities than locomotor skill competency .


Improving fundamental movement skill competency , particularly object-control skills , may contribute to increased levels of children 's MVPA throughout the day .


Australian New Zealand Clinical Trials Registry No : ACTRN12611001080910 .


Low back pain ( LBP ) is chronic disease without a curative therapy .


Alternative and complementary therapies are widely used in the management of this condition .


To evaluate the efficacy of home application of Dead Sea mud compresses to the back of patients with chronic LBP .


Forty-six consecutive patients suffering from chronic LBP were recruited .


All patients were followed at the Soroka University Rheumatic Diseases Unit .


The patients were randomized into two groups : one group was treated with mineral-rich mud compresses , and the other with mineral-depleted compresses .


Mud compresses were applied five times a week for 3 consecutive weeks .


The primary outcome was the patient 's assessment of the overall back pain severity .


The score of the Ronald & Morris questionnaire served as a secondary outcome .


Forty-four patients completed the therapy and the follow-up assessments : 32 were treated with real mud packs and 12 used the mineral-depleted packs .


A significant decrease in intensity of pain , as described by the patients , was observed only in the treatment group .


In this group , clinical improvement was clearly seen at completion of therapy and was sustained a month later .


Significant improvement in the scores of the Roland & Morris questionnaire was observed in both groups .


The data suggest that pain severity was reduced in patients treated with mineral-rich mud compresses compared with those treated with mineral-depleted compresses .


Whether this modest effect is the result of a `` true '' mud effect or other causes can not be determined in this study .


To compare magnetic imaging-assisted colonoscopy ( MIC ) with conventional colonoscopy ( CC ) .


Magnetic imaging technology provides a computer-generated image of the shape and position of the colonoscope onto a monitor to give visual guidance to the endoscopist .


It is designed to improve colonoscopy performance and tolerability for patients by enabling visualization of loop formation and endoscope position .


Recently , a new version of MIC technology was developed for which there are limited data.To evaluate this latest generation of MIC among experienced rather than inexperienced or trainee endoscopists , a prospective randomized trial was performed using only gastroenterologists with therapeutic endoscopy training .


Consecutive patients undergoing elective outpatient colonoscopy were randomized to MIC or CC , with patients blinded to their group assignment .


Endoscopic procedural metrics and quantities of conscious sedation medications were recorded during the procedures .


The procedure was classified as `` usual '' or `` difficult '' by the endoscopist at the conclusion of each case based on the need for adjunctive maneuvers to facilitate endoscope advancement .


After more than one hour post-procedure , patients completed a 10 cm visual analogue pain scale to reflect the degree of discomfort experienced during their colonoscopy .


The primary outcome was patient comfort expressed by the visual analogue pain score .


Secondary outcomes consisted of endoscopic procedural metrics as well as a sedation score derived from standardized dose increments of the conscious sedation medications .


Two hundred fifty-three patients were randomized and underwent MIC or CC between September 2011 and October 2012 .


The groups were similar in terms of the indications for colonoscopy and patient characteristics .


There were no differences in cecal intubation rates ( 100 % vs 99 % ) , insertion distance-to-cecum ( 82 cm vs 83 cm ) , time-to-cecum ( 6.5 min vs 7.2 min ) , or polyp detection rate ( 47 % vs 52 % ) between the MIC and CC groups .


The primary outcome of mean pain score ( 1.0 vs 0.9 out of 10 , P = 0.41 ) did not differ between MIC and CC groups , nor did the mean sedation score ( 8.2 vs 8.5 , P = 0.34 ) .


Within the subgroup of cases considered more challenging or difficult , time-to-cecum was significantly faster with MIC compared to CC , 10.1 min vs 13.4 min respectively ( P = 0.01 ) .


Sensitivity analyses confirmed a similar pattern of overall findings when each endoscopist was considered separately , demonstrating that the mean results for the entire group were not unduly influenced by outlier results from any one endoscopist .


Although the latest version of MIC resulted in faster times-to-cecum within a subgroup of more challenging cases , overall it was no better than CC in terms of patient comfort , sedation requirements and endoscopic procedural metrics , when performed in experienced hands .


Iron deficiency is one of the most common nutritional deficiencies worldwide .


It is more prevalent when iron requirements are increased during pregnancy and during growth spurts of infancy and adolescence .


The last stage in the process of iron depletion is characterized by a decrease in hemoglobin concentration , resulting in iron deficiency anemia .


Iron deficiency , even before it is clinically identified as anemia , compromises the immune response , physical capacity for work , and intellectual functions such as attention level .


Therefore , interventions addressing iron deficiency should be based on prevention rather than on treatment of anemia .


The aim of this study was to compare short - and medium-term effects on ferritin concentration of daily supplementation with ferrous sulfate or iron bis-glycinate chelate in schoolchildren with iron deficiency but without anemia .


Two hundred schoolchildren from public boarding schools in Mexico City who had low iron stores as assessed by serum ferritin concentration but without anemia were randomly assigned to a daily supplement of 30mg/day of elemental iron as ferrous sulfate or iron bis-glycinate chelate for 12weeks .


Iron status was evaluated at baseline , one week post-supplementation ( short term ) , and 6months ( medium term ) after supplementation .


Ferritin concentration increased significantly between baseline and post-supplementation as well as between baseline and 6months after supplementation .


One week post-supplementation no difference was found in ferritin concentration between iron compounds , but 6months after supplementation ferritin concentration was higher in the group that received bis-glycinate chelate iron .


However , there is no difference in the odds for low iron storage between 6months after supplementation versus the odds after supplementation ; nor were these odds different by type of supplement .


Hemoglobin concentration did not change significantly in either group after supplementation .


Supplementing with 30mg/d of elementary iron , either as ferrous sulfate or iron bis-glycinate chelate for 90days , showed positive effects on increasing ferritin concentration in schoolchildren with low iron stores , and this effect persisted 6months after supplementation .


Postoperative parathyroidectomy hypocalcemia probably results from acute reversal of the parathyroid hormone induced contribution of bone to maintain serum calcium concentration .


Compare the effective treatment of calcitriol regimens ( loaded and titrated ) in control hypocalcemic hyperparathyroid ( HPT ) patients who were referred for parathyroidectomy .


A randomized control , open labeled study of 25 patients who underwent parathyroidectomy in Rajavithi Hospital from August 2009 to September 2010 was conducted .


The authors randomized 25 patients with chronic kidney disease in two treatment arms of calcitriol ( A : Titrated dose regimen , B : Loaded dose regimen ) , that met criteria .


Biochemical factors available within 2 weeks before and after surgery were recorded and analyzed .


No significant difference was observed in amount of calcium gluconate intravenous use , hypocalcemia and hospital admission durations between titrated and loaded regimen groups , i.e. , p = 0.160 , 0.645 and 0.460 , respectively .


Loaded regimen ameliorated the mean reduction of day 7 postoperative mean change of serum calcium level by 0.330.99 mg/dl and median change by 2.88 mg/dl ( min , max = -0.80 , 5.64 ) compared with titrate regimen mean change ofserum calcium level by 2.682.16 mg/dl ; median change 0.28 mg/dl ( min , max = -0.84 , 1.80 ) with significance , p = 0.036 .


Loaded calcitriol regimen was superior to titrated calcitriol regimen compared with the control group the first 7 days postparathyroidectomy .


Amount of calcium gluconate intravenous used , hypocalcemia and duration of hospital stay did not show any significance .


To discuss the curative effect of traditional treatment and combination therapy for senile hip fracture .


Using prospective methods to choose 300 cases of elderly patients with hip fractures from February 2011 to December 2012 , which were randomly divided into comprehensive treatment group and conventional treatment group .


After screening , 148 case were in comprehensive treatment group , including 62 males and 86 females with an average age of ( 78.76 + / - 7.32 ) years old ranging from 60 to 88 ; 45 cases were intertrochanteric fracture of femur , 103 cases were fracture of neck of femur ; Singh index > or = IV in 74 cases , < IV in 74 cases ; preoperative Harris score was 39.90 + / - 2.28 .


There were 146 cases in conventional treatment group , including 60 males and 86 females with an average age of ( 80.00 + / - 7.06 ) years old ranging from 66 to 96 ; 50 cases were intertrochanteric fracture of femur , 96 cases were fracture of neck of femur ; Singh index > or = IV in 75 cases , < IV in 71 cases ; preoperative Harris score was 40.10 + / - 2.81 .


Preoperative general situation , leaving bed time and hospital stay , the incidence of postoperative 12 weeks Singh index > or = IV and DPD/Cr value , Harris score at 12 months after operation and the incidence of fracture again of two groups were observed and compared .


In comprehensive treatment group 140 patients were followed up for 12 to 18 months with an anverage of 14.80 + / - 1.85 .


In conventional treatment group 132 patients were followed up for 12 to 14 months with an average of 12.75 + / - 0.79 .


There were no significant differences in age , gender , the classification of fracture , preoperative Harris hip score , preoperative Singh index > or = IV level and DPD/Cr value between the two groups ( P > 0.05 ) .


Comprehensive treatment group had shorter leaving bed time and hospital stay , smaller postoperative 12 weeks DPD/Cr value and higher postoperative Harris score , higher incidence of postoperative 12 weeks Singh index > or = IV level , lower incidence of fracture again than conventional treatment group , there was statistically significant difference between two groups ( P < 0.05 ) .


For the anti-osteoporosis effect , the comprehensive treatment group has more advantage than traditional treatment group in elderly hip fracture , which can further improve the elderly hip fracture treatment and provide the reference of evidence-based medicine cooperate with rehabilitation department .


To assess the role of toothbrushing self-efficacy ( TBSE ) in diabetes management by comparing health education ( HE ) and health coaching ( HC ) in type 2 diabetes .


The data [ HbA1c , Clinical Attachment Loss ( CAL ) , TBSE ] were collected initially and after intervention .


Participants were allocated randomly to HC ( n = 77 ) and HE ( n = 109 ) groups .


The low TBSE subgroup showed greater improvement in TBSE in the HC group ( mean :23.49.2 ) than the HE group ( mean :12.410.3 ) , ( P < 0.01 ) .


The moderate TBSE group showed significant improvements only in the HC group ( P < 0.001 ) .


There was a significant reduction in HbA1c and CAL in all the TBSE subgroups in HC ( P < 0.05 ) , which was significantly higher than in the HE groups ( P < 0.05 ) .


Improvements in TBSE and CAL were explanatory variables for the reduction in HbA1c among the HC patients in all the TBSE subgroups ( P < 0.05 ) .


Among HE patients , improvement in CAL was an explanatory variable for change at HbA1c in the low TBSE subgroup .


The present findings show that HC is more effective in terms of reduced HbA1c and CAL compared with HE .


The data suggest that HC unlocks positive self-intrinsic motivation , anchoring the self-efficacy/competency beliefs for adjustment of healthy lifestyles .


Thus , TBSE may be a practical starting point for empowerment and more effective outcomes .


To investigate the efficacy and safety of telmisartan 80mg/amlodipine 5mg ( T80/A5 ) single-pill combination versus A5 in patients with essential hypertension not adequately controlled on A5 monotherapy .


Asian patients 18 years old , with inadequately controlled blood pressure ( BP ) at enrolment , who failed to achieve a seated diastolic BP ( DBP ) goal ( 90mmHg ) following 6-weeks ' open-label A5 treatment , were randomly allocated 1:1 to 8 weeks ' double-blind treatment with T80/A5 single-pill combination or A5 .


A total of 324 patients entered the double-blind treatment phase .


The adjusted meanSE reduction in seated trough DBP from baseline to week 8 was significantly greater with T80/A5 ( 12.41.0 mmHg ) than A5 ( 10.20.9 mmHg [ primary endpoint , n = 314 ] ) .


Results were similar in the subset of 262 Chinese patients .


Treatment-related adverse events were 1.9 % with T80/A5 and 2.4 % with A5 .


In Asian patients with hypertension , T80/A5 single-pill combination provided improved BP reduction after 8 weeks ' treatment compared with A5 monotherapy .


Both treatments were well tolerated .


A new acquisition scheme for T2-weighted spin-echo BOLD fMRI is introduced .


It uses a T2-preparation module to induce blood-oxygenation-level-dependent ( BOLD ) contrast , followed by a single-shot three-dimensional ( 3D ) fast gradient-echo readout with short echo time ( TE ) .


It differs from most spin-echo BOLD sequences in that BOLD contrast is generated before the readout , which eliminates the `` dead time '' due to long TE required for T2 contrast , and substantially improves acquisition efficiency .


This approach , termed `` 3D T2prep-GRE , '' was implemented at 7 Tesla ( T ) with a typical spatial ( 2.52.52.5 mm ( 3 ) ) and temporal ( TR = 2.3 s ) resolution for functional MRI ( fMRI ) and whole-brain coverage ( 55 slices ) , and compared with the widely used 2D spin-echo EPI sequence .


In fMRI experiments of simultaneous visual/motor activities , 3D T2prep-GRE showed minimal distortion and little signal dropout across the whole brain .


Its lower power deposition allowed greater spatial coverage ( 55 versus 17 slices with identical TR , resolution and power level ) , temporal SNR ( 60 % higher ) and CNR ( 35 % higher ) efficiency than 2D spin-echo EPI .


It also showed smaller T2 * contamination .


This approach is expected to be useful for ultra-high field fMRI , especially for regions near air cavities .


The concept of using T2-preparation to generate BOLD contrast can be combined with many other sequences at any field strength .


Poor response to ovarian stimulation is still a major problem in IVF .


The study presents a new stimulation protocol evaluated in a suppopulation of very difficult young poor ovarian responders .


The study consists in two sections .


The first includes data from a randomized controlled study involving forty-three young patients with a poor ovarian response in at least two previous cycles ( intended as cycle cancellation or with 3 collected oocytes ) .


Patients were randomized in two groups : group A ( control ) received FSH ( 400IU/day ) , while group B received the new stimulation protocol consisting in a sequential association of 150IU r-LH for 4 days followed by 400IU r-FSH/after downregulation with daily GnRh agonist .


The second includes data from the overall results in 65 patients treated with the new protocol compared to their previous performance with conventional cycles ( historical control ) .


Both in the RCT and in the historical control study , LH pretreatment was able to decrease the cancellation rate , to improve the in vitro performance , and to significantly increase the live birth rates .


LH pretreatment improved oocyte quantity and quality in young repeated poor responders selected in accordance with the Bologna criteria .


Procedural and clinical outcomes still remain unfavorable for patients with long coronary lesions who undergo percutaneous coronary intervention .


The current study , therefore , evaluated 2 innovative drug-eluting stents for the management of long-lesion coronary artery disease .


This randomized , multicenter , prospective trial , called the Long Drug-Eluting Stent ( LONG-DES ) V trial , compared the biodegradable polymer-based biolimus A9-eluting stent ( BES ) and the durable polymer-based platinum chromium everolimus-eluting stent ( PtCr-EES ) in 500 patients with long ( 25 mm ) coronary lesions .


The primary end point of the trial was in-segment late luminal loss at the 9-month angiographic follow-up .


The BES and PtCr-EES groups had similar baseline characteristics , with a slightly shorter lesion length in the BES group versus the PtCr-EES group ( 29.24 12.17 versus 32.27 13.84 mm ; P = 0.016 ) .


In-segment late luminal loss was comparable between the 2 groups at the 9-month angiographic follow-up ( BES , 0.14 0.38 versus PtCr-EES , 0.11 0.37 mm ; difference , 0.031 ; 95 % confidence interval , -0.053 to 0.091 ; P = 0.03 for a noninferiority margin of 0.11 , P = 0.45 for superiority ) , as was in-stent late luminal loss ( 0.20 0.41 versus 0.24 0.38 mm ; P = 0.29 ) .


The incidence of in-segment ( 6.1 % versus 4.9 % ; P = 0.63 ) and in-stent ( 3.7 % versus 4.9 % ; P = 0.59 ) binary restenosis was also similar between the groups .


There was no significant between-group difference in the rate of composite outcome of death , myocardial infarction , and target vessel revascularization ( 41 , 16.7 % in BES versus 42 , 16.5 % in PtCr-EES ; P = 0.94 ) .


BES and PtCr-EES implantation showed analogous angiographic and clinical outcomes for patients with de novo long coronary lesions .


http://www.clinicaltrials.gov .


Unique identifier : NCT01186120 .


To examine whether use of functional capacity evaluation ( FCE ) leads to better outcomes for injured workers .


Cluster randomized controlled trial conducted with analysis at level of claimant .


Rehabilitation facility .


Participants included claimants ( N = 203 ) ; of these , 103 were tested with FCE .


Data were collected on all claimants undergoing RTW assessment at the facility for musculoskeletal conditions .


Participants were predominantly employed ( 59 % ) men ( 73 % ) with chronic musculoskeletal conditions ( median duration , 496d ) .


FCEs are commonly used to identify work abilities and inform return-to-work ( RTW ) decisions .


Therefore , FCE results have important consequences .


Clinicians who were trained and experienced in performing FCEs were randomized into 2 groups .


One group included 14 clinicians who were trained to conduct a semistructured functional interview ; the other group ( control group ) continued to use standard FCE procedures .


Outcomes included RTW recommendations after assessment , functional work level at time of assessment and 1 , 3 , and 6 months after assessment , and compensation outcomes .


Analysis included Mann-Whitney U , chi-square , and t tests .


All outcomes were similar between groups , and no statistically or clinically significant differences were observed .


Mean differences between groups on functional work levels at assessment and follow-up ranged from 0.1 to 0.3 out of 4 ( 3 % -8 % difference , P > .05 ) .


Performance-based FCEs did not appear to enhance RTW outcomes beyond information gained from semistructured functional interviewing .


Use of functional interviewing has the potential to improve efficiency of RTW assessment without compromising clinical , RTW , or compensation outcomes .


Tension pneumothorax can rapidly progress to cardiac arrest and death if not promptly recognized and appropriately treated .


We sought to evaluate the effectiveness of traditional didactic slide-based lectures ( SBLs ) as compared with fresh tissue cadaver-based training ( CBT ) for placement of needle thoracostomy ( NT ) .


Forty randomly selected US Navy corpsmen were recruited to participate from incoming classes of the Navy Trauma Training Center at the LAC + USC Medical Center and were then randomized to one of two NT teaching methods .


The following outcomes were compared between the two study arms : ( 1 ) time required to perform the procedure , ( 2 ) correct placement of the needle , and ( 3 ) magnitude of deviation from the correct position .


During the study period , a total of 40 corpsmen were enrolled , 20 randomized to SBL and 20 to CBT arms .


When outcomes were analyzed , time required to NT placement was not different between the two arms .


Examination of the location of needle placement revealed marked differences between the two study groups .


Only a minority of the SBL group ( 35 % ) placed the NT correctly in the second intercostal space .


In comparison , the majority of corpsmen assigned to the CBT group demonstrated accurate placement in the second intercostal space ( 75 % ) .


In a CBT module , US Navy corpsmen were better trained to place NT accurately than their traditional didactic SBL counterparts .


Further studies are indicated to identify the optimal components of effective simulation training for NT and other emergent interventions .


Follicular lymphoma has been shown to be highly radiosensitive with responses to doses as low as 4 Gy in two fractions .


This trial was designed to explore the dose response for follicular lymphoma comparing 4 Gy in two fractions with 24 Gy in 12 fractions


FORT is a prospective randomised , unblinded , phase 3 non-inferiority study comparing radiotherapy given as 4 Gy in two fractions with a standard dose of 24 Gy in 12 fractions .


Entry criteria included all patients aged over 18 years , having local radiotherapy for radical or palliative local control , with follicular lymphoma or marginal zone lymphoma , who had received no previous treatment for at least 1 month before .


The primary outcome was time to local progression analysed on an intention-to-treat basis .


Randomisation was centralised through the Cancer Research UK and University College London Cancer Trials Centre .


Radiotherapy target sites were randomised ( 1:1 ) with minimisation stratified by histology ( follicular lymphoma vs marginal zone lymphoma ) , treatment intent ( palliative or curative ) and centre .


This trial is registered with ClinicalTrials.gov number , NCT00310167 .


299 sites were randomly assigned to 24 Gy and 315 sites to 4 Gy between April 7 , 2006 , and June 8 , 2011 , at 43 centres in the UK .


After a median follow-up of 26 months ( range 039-754 ) , 91 local progressions had been recorded ( 21 in the 24 Gy group and 70 in the 4 Gy group ) .


Time to local progression with 4 Gy was not non-inferior to 24 Gy ( hazard ratio 342 , 95 % CI 209-555 , p < 00001 ) .


Eight ( 3 % ) of 282 patients in the 24 Gy group and four ( 1 % ) of 300 in the 4 Gy group had acute grade 3-4 toxic effects .


Four ( 1 % ) patients in the 24 Gy group and four ( 1 % ) patients in the 4 Gy group had late toxic effects .


Mucositis was the most common event in the 24 Gy group ( two patients with acute mucositis and two with late mucositis ; all grade 3 ) and was not reported in the 4 Gy group .


The most common acute effect was pain at the site of irradiation ( two patients in the 4 Gy group , one patient in the 24 Gy group ; all grade 3 ) , and the most common late effect was fatigue ( two patients in the 4 Gy group , one patient in the 24 Gy group ; all grade 3 ) .


24 Gy in 12 fractions is the more effective radiation schedule for indolent lymphoma and should be regarded as the standard of care .


However , 4 Gy remains a useful alternative for palliative treatment .


Cancer Research UK .


Single-ventricle patients undergoing pediatric heart surgery are a high-risk group owing to reoxygenation injury during cardiopulmonary bypass ( CPB ) .


The present study investigated the effects of controlled reoxygenation CPB on biomarkers of organ damage , inflammation , stress , and long-term functional outcomes in cyanotic patients with either a single or double ventricle during open heart surgery .


Cyanotic patients with either a single ( n = 32 ) or double ( n = 47 ) ventricle undergoing surgical correction were randomized to receive CPB using either standard oxygen levels or controlled reoxygenation .


The markers of cardiac injury , inflammation , stress , and cerebral and hepatic injury were measured preoperatively , at 10 and 30 minutes after starting CPB , and at 10 minutes and 4 and 24 hours after CPB .


The data were analyzed using a mixed regression model .


No difference was found in the pre - or intraoperative characteristics between the standard and controlled reoxygenation CPB groups for single - or double-ventricle patients .


In the single-ventricle patients , controlled reoxygenation CPB significantly ( P < .05 ) decreased the markers of organ damage , inflammation , stress , and oxidative stress .


In contrast , the markers of inflammation and cardiac injury were not altered by controlled reoxygenation CPB in the double-ventricle patients .


Controlled reoxygenation CPB decreased the markers of organ damage , stress , inflammation , and oxidative stress in single-ventricle patients undergoing cardiac surgery .


Testosterone 2 % solution is applied to axillae and is indicated for testosterone replacement therapy in males deficient in endogenous testosterone .


This open-label crossover study evaluated the effect of deodorant/antiperspirant use and presence or absence of axillary hair on absorption of testosterone solution .


Healthy males ( N = 30 ; 50 years of age with baseline testosterone < 400ng/dL ) were randomized to one of four treatment sequences involving six treatments .


Each treatment consisted of one 1.5-mL dose of testosterone 2 % solution ( 30mg of testosterone ) applied to each axilla .


Axillae were unshaved or shaved , and were untreated or pretreated with deodorant/antiperspirant .


Blood samples were taken over 72 hours after each dose for measuring serum testosterone concentrations .


Profiles of mean testosterone concentrations were similar across treatments .


For all treatments , area under the concentration-time curve through 24 hours ( AUC [ 0-24 ] ) and 72 hours ( AUC [ 0-72 ] ) , and maximum total testosterone concentration ( Cmax ) were similar except for 15 % lower Cmax when treatment was applied after deodorant/antiperspirant to shaved vs. unshaved axillae ( least squares mean , 531ng/dL vs. 626ng/dL , respectively ; P = 0.011 ) .


This difference is not considered clinically significant .


The 95 % confidence intervals for AUC ( 0-24 ) , AUC ( 0-72 ) , and Cmax fell within the traditional bioequivalence limits of 0.8 to 1.25 .


Incidence of treatment-emergent adverse events ( TEAEs ) was low ( < 15 % ) in each treatment arm , and most TEAEs were mild .


Absorption of testosterone 2 % solution was unaffected by use of deodorant/antiperspirant or by the presence or absence of axillary hair .


Testosterone solution was generally well tolerated .


To observe the effect of electroacupuncture ( EA ) treatment on the quality of ovum , stem cell factor ( SCF ) and the pregnancy outcome in patients with polycystic ovarian syndrome ( PCOS ) , so as to explore its mechanism underlying improving pregnancy rate .


A total of 200 PCOS patients undergoing in vitro fertilization-embryo transplantation ( IVF-ET ) were randomly divided into control ( medication ) group ( n = 98 ) and EA group ( n = 102 ) .


For patients of the EA group who were undergoing controlled ovarian hyperstimulation , EA stimulation ( 5 Hz/20 Hz , 15-20 V ) was applied to bilateral Shenshu ( BL 23 ) , Qihai ( CV6 ) , bilateral Zusanli ( ST 36 ) - Sanyinjiao ( SP 6 ) , and bilateral Neiguan ( PC6 ) - Zigong ( EX-CA 1 ) for 30 min , once daily till accepting embryo transplant .


Patients of the medication group were treated with controlled ovarian hyperstimulation using Diane-35 , Decepepty , Gonadotrophin , human Chorionic Gonadotrophin , etc. .


Serum follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , testosterone ( T ) , estradiol ( E2 , and progesterone ( P ) contents were detected using chemiluminescent method .


SCF contents in the serum and follicular fluid were assayed by ELISA .


The number of retrieved oocytes , fertilization rate , cleavage rate , high quality embryo rate , ovarian hyperstimulation syndrome ( OHSS ) incidence rate , cycle cancellation rate , clinical pregnancy rate , early abortion rate , Gn dosage and administration duration , and the correlation between the high quality embryo rate and SOF level were determined .


Comparison between the two groups showed that the high quality embryo rate , and serum and follicular fluid SCF contents were significantly higher in the EA group than in the medication group ( P < 0.05 , P < 0.01 ) , while the dosage and administration duration of Gn were significantly lower in the EA group than in the medication group ( P < 0.05 ) .


A positive correlation was found between the high quality embryo rate and the SCF level in both follicular fluid and serum ( P < 0.01 ) .


No significant differences were found between the two groups in the number of retrieved oocytes , fertilization rate , cleavage rate , clinical pregnancy rate , OHSS incidence rate , cycle cancellation rate , early abortion rate , serum LH , E2 and P contents ( P > 0.05 ) .


EA can improve the high quality embryo rate , which may be related to its effect in increasing serum and follicular fluid SCF levels .


To examine the post-exercise cross-transfer effects of acute whole body vibration ( WBV ) .


Seventeen healthy male volunteers ( 20.8 1.2 y ) performed three unilateral vibration conditions in a randomized order : 1 ) WBV-50 Hz [ high amplitude ] ; 2 ) WBV-30 Hz [ low amplitude ] ; and 3 ) a control no WBV condition ( Sham ) applied to the dominant leg .


Each condition involved maximal voluntary isometric contractions ( MVC ) followed by three leg press explosive repetitions ( 40 % MVC ) with non-dominant and dominant legs ; which were conducted prior to and post vibration ( immediately ; 2 min and 5 min ) .


Surface electromygraphy ( sEMG ) of the vastus lateralis ( VL ) and medial gastrocnemius ( MG ) were measured throughout each condition .


A condition x leg x time interaction effect was detected ( p = 0.001 ) where 50 Hz-High in the stimulated leg enhanced mean velocity at post-2 min compared to 30 Hz-Low and Sham , remaining elevated at post-5 min .


Similarly , 50 Hz-High in the non-stimulated leg increased mean velocity at post-immediately and post-2 min compared to 30 Hz-Low and Sham .


There were no changes in sEMG of VL and GM in the stimulated and non-stimulated post-conditions .


WBV ( 50 Hz ) can augment cross-transfer in neuromuscular performance .


WBV could provide an alternate method of unilateral training to promote cross education explosive strength .


To assess the effectiveness of fennel on primary dysmenorrhea symptoms and menorrheal duration .


Clinical trial study .


Islamic Azad University , Toyserkan .


80 female students were randomly divided in to two groups of intervention ( n = 40 ) and control ( n = 40 ) .


The intervention group was given one soft capsule Fennel ( 30 mg ) every 4 hours , 3 days before menstruation till the 5th day and continued for 3 months .


The control group received no medication .


The severity of samples pain was graded using a visual analogue scale .


5 standard questionnaires include of Visual analog scale pain ( VAS ) , McGill pain questionnaire , the range of stress about dysmenorrheal ( VASA ) , Perceived stress scale , Well being scale were filled out in intervals of before , during and after fennel capsule uptake .


Data were analyzed by SPSS 17 software .


P < .05 was considered to be statistically significant .


The mean of nausea intensity and weakness decreased to 1.93 , and 2.88 after 3 months , whereas they were 2.37 , 6.65 in control group which indicated a significant difference .


Reduce the duration of menstrual period , a significant difference was found after two and three months of use .


Concern in terms of quality and feelings of well-being after 1 and 3 months , was observed significant difference compared with before using .


Considering the safety of herbal medicines , this drug can use to relieve dysmenorrheal signs and menstrual duration .


Vascular access devices ( VADs ) , such as peripheral or central venous catheters , are vital across all medical and surgical specialties .


To allow therapy or haemodynamic monitoring , VADs frequently require administration sets ( AS ) composed of infusion tubing , fluid containers , pressure-monitoring transducers and/or burettes .


While VADs are replaced only when necessary , AS are routinely replaced every 3-4days in the belief that this reduces infectious complications .


Strong evidence supports AS use up to 4days , but there is less evidence for AS use beyond 4days .


AS replacement twice weekly increases hospital costs and workload .


This is a pragmatic , multicentre , randomised controlled trial ( RCT ) of equivalence design comparing AS replacement at 4 ( control ) versus 7 ( experimental ) days .


Randomisation is stratified by site and device , centrally allocated and concealed until enrolment .


6554 adult/paediatric patients with a central venous catheter , peripherally inserted central catheter or peripheral arterial catheter will be enrolled over 4years .


The primary outcome is VAD-related bloodstream infection ( BSI ) and secondary outcomes are VAD colonisation , AS colonisation , all-cause BSI , all-cause mortality , number of AS per patient , VAD time in situ and costs .


Relative incidence rates of VAD-BSI per 100 devices and hazard rates per 1000 device days ( 95 % CIs ) will summarise the impact of 7-day relative to 4-day AS use and test equivalence .


Kaplan-Meier survival curves ( with log rank Mantel-Cox test ) will compare VAD-BSI over time .


Appropriate parametric or non-parametric techniques will be used to compare secondary end points .


p Values of < 0.05 will be considered significant .


Relevant ethical approvals have been received .


CONSORT Statement recommendations will be used to guide preparation of any publication .


Results will be presented at relevant conferences and sent to the major organisations with clinical practice guidelines for VAD care .


Australian New Zealand Clinical Trial Registry ( ACTRN 12610000505000 ) .


Applying mobile phones in healthcare is increasingly prioritized to strengthen healthcare systems .


Antenatal care has the potential to reduce maternal morbidity and improve newborns ' survival but this benefit may not be realized in sub-Saharan Africa where the attendance and quality of care is declining .


We evaluated the association between a mobile phone intervention and antenatal care in a resource-limited setting .


We aimed to assess antenatal care in a comprehensive way taking into consideration utilisation of antenatal care as well as content and timing of interventions during pregnancy .