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[ "To study the synergistic effects of electroacupuncture on the treatment of knee osteoarthritis after arthroscopic debridement .", "From May 2008 to July 2010 , 78 patients with knee osteoarthritis were randomly divided into two groups .", "There were 42 patients in the experimental group , including 16 males and 26 females , ranging in age from 41 to 63 years , with an average of ( 53.62 + / - 6.53 ) years ; the disease course ranged from 8 to 24 months , with an average of ( 10.35 + / - 6.42 ) months .", "The patients were treated with arthroscopic debridement combined with electroacupuncture after operation .", "There were 36 patients in the control group , including 14 males and 22 females , ranging in age from 40 to 62 years , with an average of ( 54.34 + / - 7.67 ) years ; the disease course ranged from 6 to 25 months , with an average of ( 11.94 + / - 5.13 ) months .", "Those patients were treated only with arthroscopic debridment .", "All the patients performed isometric quadriceps femoris contraction exercise and knee flexion and extension activities after operation .", "The visual analog scale ( VAS ) score and Lysholm knee score were used to evaluate the therapeutic effects .", "All the patients were followed up , and the duration ranged from 12 to 30 months , with an average of 15.6 months .", "At the final follow-up , VAS score was significantly decreased , and the Lysholm score , except for the item demanding for support , significantly increased , compared with those before surgery respectively in both groups .", "There was significant difference in VAS score between two groups after treatment .", "As to Lysholm score , there were significant differences in limp , pain , swelling , stair activity and squat , but there were no significant differences in items of interlocking and instability between two groups after treatment .", "Electroacupuncture can effectively improve the clinical symptoms and knee joint 's motor function of knee joints in patients with knee osteoarthritis , as well as the synergistic effects on the treatment of knee osteoarthritis after arthroscopic debridement , leading to a much better long-term therapeutic effect with respect of improving the function of knee joint .", "This therapy , combined with traditional Chinese medicine and Western Medicine , is worth of clinical application in the treatment of knee osteoarthritis ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Preclinical studies suggest that P2X3 receptors are expressed by airway vagal afferent nerves and contribute to the hypersensitisation of sensory neurons .", "P2X3 receptors could mediate sensitisation of the cough reflex , leading to chronic cough .", "We aimed to investigate the efficacy of a first-in-class oral P2X3 antagonist , AF-219 , to reduce cough frequency in patients with refractory chronic cough .", "We did a double-blind , placebo-controlled , two-period , crossover study at one UK centre .", "With a computer-generated sequence , we randomly assigned patients with refractory chronic cough to AF-219 , 600 mg twice a day , or to placebo ( 1:1 ) , and then , after a 2 week washout , assigned patients to receive the other treatment .", "Patients , health-care providers , and investigators were masked to sequence assignment .", "We assessed daytime cough frequency ( primary endpoint ) at baseline and after 2 weeks of treatment using 24 h ambulatory cough recordings .", "The primary analysis used a mixed effects model with the intention-to-treat population .", "This study was registered at ClinicalTrials.gov , number NCT01432730 .", "Of 34 individuals assessed between Sept 22 , 2011 , and Nov 29 , 2012 , we randomly assigned 24 patients ( mean age 545 years ; SD 111 ) .", "In the observed case analysis , cough frequency was reduced by 75 % when patients were allocated to AF-219 compared when allocated to placebo ( p = 00003 ) .", "Daytime cough frequency fell from a mean 37 coughs per h ( SD 32 ) to 11 ( 8 ) coughs per h after AF-219 treatment versus 65 ( 163 ) coughs per h to 44 ( 51 ) coughs per h after placebo .", "Six patients withdrew before the end of the study because of taste disturbances , which were reported by all patients taking AF-219 .", "P2X3 receptors seem to have a key role in mediation of cough neuronal hypersensitivity .", "Antagonists of P2X3 receptors such as AF-219 are a promising new group of antitussives .", "Afferent Pharmaceuticals ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Children with borderline to mild intellectual disability ( BMID ) have been shown to be at increased risk for psychosocial problems .", "The presence of these psychosocial problems leads to parenting stress .", "Stepping Stones Triple P ( SSTP ) is a parenting support program to support parents with children with BMID and psychosocial problems .", "The aim of this study was to evaluate the effectiveness of SSTP compared to Care as Usual ( CAU ) in reducing psychosocial problems in children with BMID .", "We conducted a randomized controlled trial in the Northern provinces of the Netherlands .", "Parents of children aged 5 to 12 with borderline ( IQ 70 to 85 ) or mild ( IQ 70 to 50 ) ID and psychosocial problems were invited .", "Psychosocial problems were identified using the Strengths and Difficulties Questionnaire ( SDQ ) parent report ( 14 ) .", "Measurements were assessed before the intervention ( T0 ) , immediately after the intervention ( T1 ) and after a follow-up of six months ( T2 ) .", "SSTP takes 8 to 10 individual sessions of 40-90 minutes , provided over 10 to 12weeks .", "CAU concerned any service , except SSTP .", "Primary outcomes were the child 's psychosocial problems ( SDQ parent and teacher forms and the Eyberg Child Behavior Inventory , ECBI ) .", "Secondary outcomes were parenting stress ( Parenting Stress Index , PSI ) and parenting skills ( Alabama Parenting Questionnaire , APQ ) .", "In total 209 parents of children aged 5 to 12 with BMID were allocated blindly to either SSTP ( n = 111 ) or CAU ( n = 98 ) .", "In the intention to treat analyses , SSTP achieved no significantly better effect than CAU for the SDQ parent report , the ECBI and the APQ on the short - and long - term .", "In the short term , SSTP was significantly more effective than CAU for the SDQ teacher report ( B = -2.25 , 95 % CI -3.79 to -0.71 ) and the PSI ( B = -7.06 , 95 % CI -12.11 to -2.01 ) .", "For both SDQ teacher report and PSI , there was no statistically significant effect in the long term .", "Dropout from SSTP was considerable ( 49 % ) , with the effects being solely found in the adherent SSTP subgroup .", "SSTP had some short-term advantages over CAU , but not in the longer term .", "Dutch Trial Register NTR2624 .", "Registered 26 November 2010 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "We aimed to assess the safety and tolerability of different doses of canakinumab versus placebo in patients with type 2 diabetes mellitus ( T2DM ) .", "Data were pooled from three studies in 1026 T2DM patients with different routes of administration , treatment regimens and follow-up duration .", "Canakinumab groups were categorised as low ( 0.03 mg/kg i.v. once ; N = 20 ) , intermediate ( 0.1 and 0.3 mg/kg i.v. once , 5 and 15 mg s.c. monthly ; N = 247 ) , medium ( 1.5 mg/kg i.v. once , 50 mg s.c. monthly and 150 mg s.c. once ; N = 268 ) , and high doses ( 10 mg/kg i.v. once and 150 mg s.c. monthly ; N = 137 ) and compared with placebo ( N = 354 ) .", "Incidences of adverse events ( AEs ) , serious AEs ( SAEs ) , discontinuations due to AEs , deaths , AEs of special interest related to interleukin-1 inhibition and T2DM disease , and laboratory abnormalities related to haematology and biochemistry parameters were reported .", "Safety was also analysed by age ( < 65 , 65 ) and gender .", "Average exposure across all groups was6 months ( maximum ~ 17 months ) .", "No dose response in AEs was observed but a trend towards more patients having at least one AE across canakinumab groups relative to placebo ( P = 0.0152 ) was observed .", "SAEs were few and the incidence rate for most canakinumab groups was lower than that of placebo group except for the high-dose group ( 0.94 % versus 0.58 % per month in placebo ) .", "A total of five patients discontinued treatment due to AEs across treatment groups .", "No death was reported in any of the three studies .", "A small , non-significant increase in the incidence rate of infection AEs was observed on canakinumab groups relative to placebo .", "Canakinumab was associated with mostly mild decreases in WBC , neutrophils and platelet counts .", "Additionally , mild increases in SGPT , SGOT and bilirubin were reported .", "Overall , despite small differences , no clinically relevant findings were observed with respect to laboratory values and vital signs .", "This pooled analysis demonstrated that canakinumab was safe and well tolerated over a treatment period up to 1.4 years at the four pooled doses evaluated , in agreement with safety findings reported in the individual studies ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "This study was undertaken to compare the immunogenicity of a three dose and five dose schedule of an oral live-attenuated human rotavirus vaccine , Rotarix in south Indian infants .", "Healthy infants ( N = 90 ) , six to seven weeks of age were enrolled to receive three doses ( n = 45 ) or five doses of Rotarix vaccine ( n = 45 ) along with other scheduled vaccines , each dose separated by a four week interval .", "Blood samples were taken before vaccination and one month post-dose three in the Rotarix three dose group and one month post-dose five in the Rotarix five dose group ; all were tested for anti-rotavirus IgA by an antibody sandwich enzyme immunoassay .", "At baseline , > 50 % of infants had > 20 units of anti-rotavirus IgA .", "The seroconversion rates after three and five doses were low and not significantly different in the two groups .", "However , among vaccine responders , children seropositive at baseline showed a much greater absolute increase in IgA antibody levels than children seronegative at baseline .", "Rotarix vaccine showed low immunogenicity in south Indian children and increasing the number of doses did not increase the proportion of infants seroconverting after vaccination ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To determine whether outcomes for patients with cellulitis treated with oral antimicrobials are as good as for those who are treated with parenteral antimicrobials .", "A prospective randomized non-inferiority trial was conducted at a tertiary teaching hospital in Melbourne , Australia .", "Participants were patients referred by the emergency department for treatment of uncomplicated cellulitis with parenteral antimicrobials .", "Patients were randomized to receive either oral cefalexin or parenteral cefazolin .", "Parenteral antimicrobials were changed to oral after the area of cellulitis ceased progressing .", "The primary outcome was days until no advancement of the area of cellulitis .", "A non-inferiority margin of 15 % was set for the oral arm compared with the parenteral arm .", "Secondary outcomes were failure of treatment , pain , complications and satisfaction with care .", "This trial is registered with the Australian New Zealand Clinical Trials Registry ( ACTRN12611000685910 ) .", "Twenty-four patients were randomized to oral antimicrobials and 23 to parenteral antimicrobials .", "Mean days to no advancement of cellulitis was 1.29 ( SD 0.62 ) for the oral arm and 1.78 ( SD 1.13 ) for the parenteral arm , with a mean difference of -0.49 ( 95 % CI : -1.02 to +0.04 ) .", "The upper limit of the 95 % CI of the difference in means of +0.04 was below the 15 % non-inferiority margin of +0.27 days , indicating non-inferiority .", "More patients failed treatment in the parenteral arm ( 5 of 23 , 22 % ) compared with the oral arm ( 1 of 24 , 4 % ) , although this difference was not statistically significant ( P = 0.10 ) .", "Pain , complications and satisfaction with care were similar for both groups .", "Oral antimicrobials are as effective as parenteral antimicrobials for the treatment of uncomplicated cellulitis ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "This study aimed to examine the effects of a multidisciplinary treatment program on health-related quality of life of Iranian patients living with chronic low back , at 12months follow-up .", "This study is an extended follow-up of an original randomized , controlled trial with registration number NCT00600197 .", "In the present study 87 patients in an intervention group and 91 patients in a control group were assessed at 12months follow-up .", "The intervention was a group-based multidisciplinary rehabilitation program which continued by monthly motivational consultation by telephone from 6 to 12months after intervention .", "Data from three standard measures , Short Form 36 ( SF-36 ) , QDS and RDQ were collected at 3 , 6 and 12months follow-up and analyzed through repeated measures analysis of variance .", "Despite the similarity between the two groups who completed the 6month follow-up in terms of all baseline variables , there were significant differences between the two groups in all domains of the SF-36 scale , as well as QDS and RDQ scales ( P < 0.05 ) .", "Also , there were differences within each group over time in the SF-36 domains and disability measurements ( P < 0.05 ) .", "The physical function mean score differed significantly when the interaction between groups and time points was examined ( P = 0.02 ) .", "This study indicates that the multidisciplinary program could improve the domains of health related quality of life and disability in chronic low back pain patients up to 12months ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "The optimal duration of dual antiplatelet therapy ( DAPT ) following second-generation drug-eluting stent ( DES ) implantation is still debated .", "The aim of this study was to test the noninferiority of 6 versus 12 months of DAPT in patients undergoing percutaneous coronary intervention with second-generation DES .", "The SECURITY ( Second Generation Drug-Eluting Stent Implantation Followed by Six - Versus Twelve-Month Dual Antiplatelet Therapy ) trial was a 1:1 randomized , multicenter , international , investigator-driven , noninferiority study conducted from July 2009 to June 2014 .", "Patients with a stable or unstable angina diagnosis or documented silent ischemia undergoing revascularization with at least 1 second-generation DES were eligible .", "The primary endpoint was a composite of cardiac death , myocardial infarction ( MI ) , stroke , definite or probable stent thrombosis , or Bleeding Academic Research Consortium ( BARC ) type 3 or 5 bleeding at 12 months .", "The main secondary endpoint was a composite of cardiac death , MI , stroke , definite or probable stent thrombosis , or BARC type 2 , 3 , or 5 bleeding at 12 and 24 months .", "Overall , 1,399 patients were enrolled in the study and randomized to receive 6 months ( n = 682 ) versus 12months ( n = 717 ) DAPT .", "The primary composite endpoint occurred , respectively , in 4.5 % versus 3.7 % ( risk difference 0.8 % ; 95 % confidence interval [ CI ] : -2.4 % to 1.7 % ; p = 0.469 ) at 12 months .", "The upper 95 % CI limit was lower than the pre-set margin of 2 % , confirming the noninferiority hypothesis ( p < 0.05 ) .", "Moreover , no differences were observed in the occurrence of the secondary endpoint at 12 months ( 5.3 % vs. 4.0 % , difference : 1.2 % ; 95 % CI : -1.0 to 3.4 ; p = 0.273 ) and between 12 and 24 months ( 1.5 % vs. 2.2 % , difference : -0.7 % ; 95 % CI : -2.1 to 0.6 ; p = 0.289 ) .", "Finally , no differences were observed in definite or probable stent thrombosis at 12 months ( 0.3 % vs. 0.4 % ; difference : -0.1 % ; 95 % CI : -0.7 to 0.4 ; p = 0.694 ) and between 12 and 24 months of follow-up ( 0.1 % vs. 0 % ; difference : 0.1 % ; 95 % CI : -0.1 to 0.4 ; p = 0.305 ) .", "In a low-risk population , the noninferiority hypothesis of 6 vs. 12 months DAPT following second-generation DES implantation appears accepted for the incidence of cardiac death , MI , stroke , definite/probable stentthrombosis , and BARC type 3 or 5 bleeding at 12 months .", "( Second Generation Drug-Eluting Stent Implantation Followed by Six - Versus Twelve-Month Dual Antiplatelet Therapy ; NCT00944333 ) ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Lafutidine is a new H2-blocker in India claimed to be more potent and effective than existing H2-blockers .", "Proton pump inhibitors ( PPIs ) , by virtue of their mechanism of action , have greater efficacy than H2-blockers in gastric acid suppression .", "However , clinical trials comparing H2-blockers directly with PPIs are limited .", "We carried out a head-to-head comparison of the effectiveness of lafutidine versus the PPI pantoprazole in uninvestigated dyspepsia [ CTRI/2013/12 / 004261 ] .", "A prospective , open label , randomized , controlled trial was conducted in a tertiary care hospital .", "Ambulatory adult patients with dyspepsia , not yet subjected to endoscopy , were recruited if they had at least moderately severe symptoms , defined as a score of 4 on a 7-point Global Overall Symptom ( GOS ) Scale .", "Those with alarm features or significant comorbidity were excluded .", "Subjects received either once daily lafutidine 10 mg or pantoprazole 40 mg , orally , for 8 weeks .", "Reflux , dysmotility and pain scores were assessed by Modified Frequency Scale for the Symptoms of Gastroesophageal Reflux Disease ( mFSSGERD ) , and quality of life ( QoL ) by SF-8 scale .", "The latter had physical and mental components summarized by physical component summary score ( PCS ) and a mental component summary score ( MCS ) .", "Of 122 patients enrolled , data of 57 on lafutidine and 60 on pantoprazole were analyzed .", "At 4 weeks , proportion of subjects responding ( GOS score 2 ) in the two arms ( lafutidine 45.61 % vs. pantoprazole 48.33 % , P = 0.854 ) or showing symptom resolution ( GOS score 1 ) ( lafutidine 12.28 % vs. pantoprazole 5.00 % ; P = 0.197 ) were comparable .", "Similarly at 8 weeks , both responder ( lafutidine 52.63 % vs. pantoprazole 56.67 % ; P = 0.712 ) and symptom resolution proportions ( lafutidine 33.33 % vs. pantoprazole 30 % ; P = 0.843 ) were comparable .", "Total score on mFSSGERD scale , as well as all its three component scores , and PCS and MCS scores on QoL SF-8 scale showed improvement but no statistically significant difference between the two arms .", "Tolerability of both drugs was excellent .", "Lafutidine is well-tolerated and there is no clinically worthwhile difference between the two drugs in the empirical treatment of uninvestigated dyspepsia ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "An increasing number of patients with heart failure receive implantable cardioverter-defibrillators ( ICDs ) or cardiac resynchronisation defibrillators ( CRT-Ds ) with telemonitoring function .", "Early detection of worsening heart failure , or upstream factors predisposing to worsening heart failure , by implant-based telemonitoring might enable pre-emptive intervention and improve outcomes , but the evidence is weak .", "We investigated this possibility in IN-TIME , a clinical trial .", "We did this randomised , controlled trial at 36 tertiary clinical centres and hospitals in Australia , Europe , and Israel .", "We enrolled patients with chronic heart failure , NYHA class II-III symptoms , ejection fraction of no more than 35 % , optimal drug treatment , no permanent atrial fibrillation , and a recent dual-chamber ICD or CRT-D implantation .", "After a 1 month run-in phase , patients were randomly assigned ( 1:1 ) to either automatic , daily , implant-based , multiparameter telemonitoring in addition to standard care or standard care without telemonitoring .", "Investigators were not masked to treatment allocation .", "Patients were masked to allocation unless they were contacted because of telemonitoring findings .", "Follow-up was 1 year .", "The primary outcome measure was a composite clinical score combining all-cause death , overnight hospital admission for heart failure , change in NYHA class , and change in patient global self-assessment , for the intention-to-treat population .", "The trial is registered with ClinicalTrials.gov , number NCT00538356 .", "We enrolled 716 patients , of whom 664 were randomly assigned ( 333 to telemonitoring , 331 to control ) .", "Mean age was 655 years and mean ejection fraction was 26 % .", "285 ( 43 % ) of patients had NYHA functional class II and 378 ( 57 % ) had NYHA class III .", "Most patients received CRT-Ds ( 390 ; 587 % ) .", "At 1 year , 63 ( 189 % ) of 333 patients in the telemonitoring group versus 90 ( 272 % ) of 331 in the control group ( p = 0013 ) had worsened composite score ( odds ratio 063 , 95 % CI 043-090 ) .", "Ten versus 27 patients died during follow-up .", "Automatic , daily , implant-based , multiparameter telemonitoring can significantly improve clinical outcomes for patients with heart failure .", "Such telemonitoring is feasible and should be used in clinical practice .", "Biotronik SE & Co. .", "KG ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "The aim of this prospective randomized trial was to compare operative factors , postoperative outcomes , and surgical complications of neck dissection ( ND ) when using the harmonic scalpel ( HS ) versus conventional haemostasis ( CH ) ( classic technique of tying and knots , resorbable ligature , and bipolar diathermy ) .", "Sixty-one patients who underwent ND with primary head and neck cancer ( HNSCC ) resection were enrolled in this study and were randomized into two homogeneous groups : CH ( conventional haemostasis with classic technique of tying and knots , resorbable ligature , and bipolar diathermy ) and HS ( haemostasis with harmonic scalpel ) .", "Outcomes of the study included operative time , intraoperative blood loss , drainage volume , postoperative pain , hospital stay , and incidence of intraoperative and postoperative complications .", "The use of the HS reduced significantly the operating time , the intraoperative blood loss , the postoperative pain , and the volume of drainage .", "No significant difference was observed in mean hospital stay and perioperative , and postoperative complications .", "The HS is a reliable and safe tool for reducing intraoperative blood loss , operative time , volume of drainage and postoperative pain in patients undergoing ND for HNSCC .", "Multicenter randomized studies need to be done to confirm the advantages of this technique and to evaluate the cost-benefit ratio ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Pregnancy and lactation in adolescents with low calcium intake may impair fetal growth and infant bone mass .", "We investigated the effects of calcium plus vitamin D supplementation during pregnancy in Brazilian adolescent mothers consuming low calcium diets ( 600 mg/d ) on fetal biometry and infant bone mass , and the relation between infant and maternal bone mass during early lactation .", "Infants of mothers who received calcium ( 600 mg/d ) plus cholecalciferol ( 200 IU/d ) supplementation ( n = 30 ) or placebo ( n = 26 ) from 26 wk of gestation until parturition were studied .", "Fetal biometric measurements at 23 and 36 wk of gestation were obtained from medical records .", "Infant anthropometric and total body bone measurements [ bone mineral content ( BMC ) , bone area ( BA ) , and bone mineral density ( BMD ) ] at 5 wk postpartum were assessed by dual-energy X-ray absorptiometry .", "Maternal BMD z scores for total body , lumbar spine , total hip , and femoral neck at 5 wk postpartum were obtained .", "Group comparisons were adjusted for significant covariates .", "Maternal mean serum 25-hydroxyvitamin D was 59 nmol/L at baseline in both groups .", "No differences in fetal measurements at 36 wk of gestation were observed between the groups , except for body weight and its increment from 23 to 36 wk , which were higher in the supplemented group ( 6.8 % , P = 0.014 and 10.5 % , P = 0.07 , respectively ) .", "Infant BMC ( 61.1 21.7 g ) , BA ( 167 79 cm ( 2 ) ) , and BMD ( 0.385 0.069 g/cm ( 2 ) ) did not significantly differ between the groups .", "In the placebo group , infant BMC and BA were negatively correlated with maternal BMD z scores for total body ( r = -0.40 and r = -0.47 ; P < 0.05 ) and hip ( r = -0.41 and r = -0.46 ; P < 0.05 ) .", "In contrast , no correlations were observed in the supplemented group .", "Calcium and vitamin D supplementation of the adolescents studied resulted in higher fetal body weight at 36 wk of gestation and had no effect on infant bone mass at 5 wk postpartum .", "Because correlations between maternal and infant bone mass were evident only in the placebo group , infant bone mass appeared to be more dependent on maternal skeletal mass when calcium intake was low .", "This trial was registered at clinicaltrials.gov as NCT01732328 ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Skill readiness remains a challenge for all health care professionals who are involved in direct patient care .", "Researchers suggest that skill retention may decrease within 6 months of an educational session .", "The purpose of this study was to explore competency retention for high-risk , low-frequency procedures , specifically , managing a difficult airway and placing a laryngeal mask airway , using a web-based content refresher .", "The pilot study was conducted in two sessions .", "Session one established clinical skill competency .", "Six months later , the advanced practice RNs were randomized into two groups .", "Group 1 reviewed didactic content and participated in a complex airway management simulation .", "Group 2 participated only in a complex airway management simulation .", "This study showed a positive trend in maintaining competency for a low-frequency procedure for which complex airway management was given , using web-based content review .", "It is feasible to maintain competency for low-frequency procedures using web-based content refreshers .", "This pilot study benefited advanced practice nurses by providing them with the potential to maintain competency in this high-risk , low-frequency procedure .", "Continuing education is an important consideration for health care organizations ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Breast cancer accounts for almost 30 % of all cancers and is the second leading cause of cancer deaths in women in Scotland .", "Screening is key to early detection .", "The Scottish Breast Screening Programme is a nationwide , free at point of delivery screening service , to which all women aged between 50 and 70 years are invited to attend every 3 years .", "Currently over three-quarters of invited women regularly attend screening .", "However , women from more deprived areas are much less likely to attend : for example in the 3 years from 2010-2012 only 63 % of women in the most deprived area attended the East of Scotland Breast Screening programme versus 81 % in the least deprived .", "Research has suggested that reminders ( telephone or letter ) and brief , personalised interventions addressing barriers to attendance may be helpful in increasing uptake in low-income women .", "We will employ a brief telephone reminder and support intervention , whose purpose is to elicit and address any mistaken beliefs women have about breast screening , with the aim that the perceived benefits of screening come to outweigh any perceived barriers for individuals .", "We will test whether this intervention , plus a simple anticipated regret manipulation , will lead to an increase in the uptake of breast cancer screening amongst low-income women who have failed to attend a first appointment , in a randomised controlled trial with 600 women .", "Participants will be randomly allocated to one of four treatment arms i.e. 1 ) Letter reminder ( i.e. Treatment as usual : CONTROL ) ; 2 ) Telephone reminder ( TEL ) , 3 ) Telephone reminder plus telephone support ( TEL-SUPP ) and 4 ) Telephone reminder plus support plus AR ( TEL-SUPP-AR ) .", "The primary outcome will be attendance at breast screening within 3 months of the reminder letter .", "If this simple telephone support intervention ( with or without AR intervention ) leads to a significant increase in breast screening attendance , this would represent a rare example of a theoretically-driven , relatively simple psychological intervention that could result in earlier detection of breast cancer amongst an under-served group of lower socio-economic women .", "Current Controlled trials : ISRCTN06039270 .", "Registered 16th January 2014 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "Brief physician counselling has been shown to be effective in improving smokers ' behaviour .", "If the counselling sessions can be given at the workplace , this would benefit a larger number of smokers .", "This study aimed to determine the effectiveness of a ten-minute physician counseling session at the workplace in improving smoking behaviour .", "This prospective randomised control trial was conducted on smokers in a factory .", "A total of 163 participants were recruited and randomised into control and intervention groups using a table of random numbers .", "The intervention group received a ten-minute brief physician counselling session to quit smoking .", "Stages of smoking behaviour were measured in both groups using a translated and validated questionnaire at baseline , one month and three months post intervention .", "There was a significant improvement in smoking behaviour at one-month post intervention ( p = 0.024 , intention to treat analysis ; OR = 2.525 ; CI = 1.109-5 .747 ) .", "This was not significant at three-month post intervention ( p = 0.946 , intention to treat analysis ; OR = 1.026 ; 95 % CI = 0.486-2 .168 ) .", "A session of brief physician counselling was effective in improving smokers ' behaviour at workplace , but the effect was not sustained ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Chronic tinnitus negatively affects the quality of life for millions of people .", "This clinical trial assesses a potential treatment for tinnitus .", "To determine if repetitive transcranial magnetic stimulation ( rTMS ) can reduce the perception or severity of tinnitus and to test the hypothesis that rTMS will result in a statistically significantly greater percentage of responders to treatment in an active rTMS group compared with a placebo rTMS group .", "A randomized , participant and clinician or observer-blinded , placebo-controlled clinical trial of rTMS involving individuals who experience chronic tinnitus .", "Follow-up assessments were conducted at 1 , 2 , 4 , 13 , and 26 weeks after the last treatment session .", "The trial was conducted between April 2011 and December 2014 at Portland Veterans Affairs Medical Center among 348 individuals with chronic tinnitus who were initially screened for participation .", "Of those , 92 provided informed consent and underwent more detailed assessments .", "Seventy individuals met criteria for inclusion and were randomized to receive active or placebo rTMS .", "Sixty-four participants ( 51 men and 13 women , with a mean [ SD ] age of 60.6 [ 8.9 ] years ) were included in the data analyses .", "No participants withdrew because of adverse effects of rTMS .", "Participants received 2000 pulses per session of active or placebo rTMS at a rate of 1-Hz rTMS daily on 10 consecutive workdays .", "The Tinnitus Functional Index ( TFI ) was the main study outcome .", "Our hypothesis was tested by comparing baseline and posttreatment TFIs for each participant and group .", "Overall , 18 of 32 participants ( 56 % ) in the active rTMS group and 7 of 32 participants ( 22 % ) in the placebo rTMS group were responders to rTMS treatment .", "The difference in the percentage of responders to treatment in each group was statistically significant ( ( 1 ) ( 2 ) = 7.94 , P < .005 ) .", "Application of 1-Hz rTMS daily for 10 consecutive workdays resulted in a statistically significantly greater percentage of responders to treatment in the active rTMS group compared with the placebo rTMS group .", "Improvements in tinnitus severity experienced by responders were sustained during the 26-week follow-up period .", "Before this procedure can be implemented clinically , larger studies should be conducted to refine treatment protocols .", "clinicaltrials.gov Identifier : NCT01104207 ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The aim of the current study was to compare block of the sciatic nerve through the anterior approach by two methods , namely , the nerve-stimulator guided and ultrasound-guided , with or without nerve stimulation , with regard to the ease of performance , reliability and safety of this approach .", "36 adult patients were randomly allocated equally into one of 2 main groups : `` Nerve Stimulator-Guided Group ( NSG ) '' where the nerve was located by nerve stimulator only and `` Ultrasound guided group ( USG ) '' where the sciatic nerves were blocked by a stimulated needle under guidance of the ultrasound .", "Assessment of performing each technique , sensory and motor blockades , occurrence of acute systemic toxicity and haematoma formation were compared .", "Only one-third of the sciatic nerves could be visualized by US .", "This did not affect the block execution time but caused less number of needle passes in a statistically significant value .", "Sensory and motor block showed significant differences between the 2 groups .", "Criteria of acute systemic toxicity and occurrence of hematoma were not reported in both groups .", "Results of the current study showed that the addition of ultrasound to nerve stimulator in the anterior approach to the sciatic nerve block added only little to the ease of performance , reliability and safety .", "This was because only one-third of the nerves could be seen .", "More practice , better machines and new blocking techniques may be needed to overcome the problem of anisotropy of the nerve ." ]

[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To investigate how radiotherapy ( XRT ) adds to tumor control using a standardized surgical technique with meticulous control of surgical margins in a randomized trial with 20 years of follow-up .", "Three hundred eighty-one women with pT1N0 breast cancer were randomly assigned to sector resection with ( XRT group ) or without ( non-XRT group ) postoperative radiotherapy to the breast .", "With follow-up through 2010 , we estimated cumulative proportion of recurrence , breast cancer death , and all-cause mortality .", "The cumulative probability of a first breast cancer event of any type after 20 years was 30.9 % in the XRT group and 45.1 % in the non-XRT group ( hazard ratio [ HR ] , 0.58 ; 95 % CI , 0.41 to 0.82 ) .", "The benefit of radiotherapy was achieved within the first 5 years .", "After 20 years , 50.4 % of the women in the XRT group died compared with 54.0 % in the non-XRT group ( HR , 0.92 ; 95 % CI , 0.71 to 1.19 ) .", "The cumulative probability of contralateral cancer or death as a result of cancer other than breast cancer was 27.1 % in the XRT group and 24.9 % in the non-XRT group ( HR , 1.17 ; 95 % CI , 0.77 to 1.77 ) .", "In an anticipated low-risk group , the cumulative incidence of first breast cancer of any type was 24.8 % in the XRT group and 36.1 % in the non-XRT group ( HR , 0.61 ; 95 % CI , 0.35 to 1.07 ) .", "Radiotherapy protects against recurrences during the first 5 years of follow-up , indicating that XRT mainly eradicates undetected cancer foci present at primary treatment .", "The similar rate of recurrences beyond 5 years in the two groups indicates that late recurrences are new tumors .", "There are subgroups with clinically relevant differences in risk ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Patients undergoing cardiac surgery presenting with chronic obstructive pulmonary disease ( COPD ) have a higher 30-day mortality risk .", "In these patients , pulmonary dysfunction linked to an inflammatory response is frequent after cardiac operations using cardiopulmonary bypass ( CPB ) , which causes pulmonary hypoperfusion .", "We hypothesize that selective pulmonary perfusion ( sPP ) of the lungs leads to a reduction of pulmonary inflammation and a better clinical outcome .", "Fifty-nine COPD patients ( forced expiratory volume in 1 s/vital capacity < 70 % ) undergoing cardiac surgery procedures ( coronary artery bypass grafting 64 % , valve 14 % ) were block-randomized to sPP ( venous blood , temperature 2C , 4 l ) or standard CPB ( 28/28 ) .", "The primary end-point of the study was to evaluate the effect of pulmonary perfusion on gas exchange by measuring alveolar-arterial oxygen gradient .", "The surrogate end-points were inflammatory response , intensive care unit ( ICU ) stay , time on respirator ( TOR ) and major adverse cardiac and cerebrovascular events .", "A cytokine assay for interleukin-1 , IL-6 , IL-10 , tumour necrosis factor - ( TNF - ) and polymorphonuclear elastase was performed with peripheral blood at different time-points [ ( t1 ) pre-CPB , ( t2 ) end of CPB , ( t3 ) 3 h , ( t4 ) 24 h , ( t5 ) 48 h postoperatively ] .", "Repeated-measure analysis of variance and non-parametric statistics were used to assess the between-group and during time differences .", "The two groups proved comparable for perioperative variables .", "Serum cytokines were not different in the two groups throughout the study ( P > 0.05 at single time-points ) , but as a function of time , the markers of the inflammatory response increased after CBP ( P < 0.05 pre-CPB to 24 h ) .", "Clinical end-points were statistically comparable in both groups , but with a trend towards a shorter TOR ( 72 159 h/106 193 h ) and ICU stay ( 3.9 7.2 days/5 .5 9.2 days ) in the sPP group despite a slightly longer time on extracorporeal circulation ( 120 vs 158 min ) .", "These results indicate a non-significant trend that repeated hypothermic lung perfusion with venous blood during CPB may have a protective effect on the lungs .", "A multicentre study design and larger cohort seem necessary to demonstrate the benefits of sPP more clearly ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "This study compared efficacy and safety of the selective relaxant binding agent sugammadex ( 2mg/kg ) with neostigmine ( 50g/kg ) for neuromuscular blockade ( NMB ) reversal in Chinese and Caucasian subjects .", "This was a randomized , active-controlled , multicenter , safety-assessor-blinded study ( NCT00825812 ) in American Society of Anesthesiologists Class 1-3 subjects undergoing surgery with propofol anesthesia .", "Rocuronium 0.6 mg/kg was administered for endotracheal intubation , with 0.1-0 .2 mg/kg maintenance doses given as required .", "NMB was monitored using TOF-Watch ( ) SX .", "At second twitch reappearance , after last rocuronium dose , subjects received sugammadex 2mg/kg or neostigmine 50g/kg plus atropine 10-20g / kg , according to randomization .", "Primary efficacy variable was time from sugammadex/neostigmine to recovery of the train-of-four ( TOF ) ratio to 0.9 .", "Overall , 230 Chinese subjects ( sugammadex , n = 119 , neostigmine , n = 111 ) ; and 59 Caucasian subjects ( sugammadex , n = 29 , neostigmine , n = 30 ) had evaluable data .", "Geometric mean ( 95 % CI ) time to recovery to TOF ratio 0.9 was 1.6 ( 1.5-1 .7 ) min with sugammadex vs 9.1 ( 8.0-10 .3 ) min with neostigmine in Chinese subjects .", "Corresponding times for Caucasian subjects were 1.4 ( 1.3-1 .5 ) min and 6.7 ( 5.5-8 .0 ) min , respectively .", "Sugammadex 2mg/kg was generally well tolerated , with no serious adverse events reported .", "There was no residual NMB or recurrence of NMB .", "Both Chinese and Caucasian subjects recovered from NMB significantly faster after sugammadex 2mg/kg vs neostigmine 50g/kg , with a ~ 5.7 times ( p < 0.0001 ) faster recovery with sugammadex vs neostigmine in Chinese subjects .", "Sugammadex was generally well tolerated .", "ClinicalTrials.gov Identifier : NCT00825812 ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Little is known about the factors that predict for gastrointestinal stromal tumor ( GIST ) recurrence in patients treated with adjuvant imatinib .", "Risk factors for GIST recurrence were identified , and 2 risk stratification scores were developed using the database of the Scandinavian Sarcoma Group ( SSG ) XVIII trial , where 358 patients with high-risk GIST with no overt metastases were randomly assigned to adjuvant imatinib 400 mg/day either for 12 or 36 months after surgery .", "The findings were validated in the imatinib arm of the American College of Surgeons Oncology Group Z9001 trial , where 359 patients with GIST were randomized to receive imatinib and 354 were to receive placebo for 12 months .", "Five factors ( high tumor mitotic count , nongastric location , large size , rupture , and adjuvant imatinib for 12 months ) were independently associated with unfavorable recurrence-free survival ( RFS ) in a multivariable analysis in the SSGXVIII cohort .", "A risk score based on these 5 factors had a concordance index with GIST recurrence of 78.9 % .", "When a simpler score consisting of the 2 strongest predictive factors ( mitotic count and tumor site ) was devised , the groups with the lowest , intermediate high , and the highest risk had 5-year RFS of 76.7 % , 47.5 % , and 8.4 % , respectively .", "Both scores were strongly associated with RFS in the validation cohort ( P < .001 for each comparison ) .", "The scores generated were effective in stratifying the risk of GIST recurrence in patient populations treated with adjuvant imatinib .", "Patients with nongastric GIST with a high mitotic count are at a particularly high risk for recurrence ." ]

[ "BACKGROUND", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To evaluate both the short - and long-term effectiveness of a lifestyle intervention on physical fitness in adolescents and young adults with cerebral palsy ( CP ) .", "Single-blind , randomized controlled trial .", "University hospitals and rehabilitation clinics .", "Adolescents and young adults ( N = 57 ) with spastic CP classified in Gross Motor Function Classification System levels I through IV ; of these , 42 completed the study .", "A 6-month lifestyle intervention consisting of physical fitness training combined with counseling sessions focused on physical behavior and sports participation .", "Physical fitness , including measures of cardiopulmonary fitness , muscle strength , and body composition .", "Favorable short - and medium-term effects were found for peak oxygen consumption , oxygen consumption , and load on the anaerobic threshold and waist circumference .", "Favorable long-term effects were found for sum of skinfolds , systolic blood pressure , and total cholesterol .", "This exploratory study showed that the lifestyle intervention was effective in improving cardiopulmonary fitness and body composition .", "Effects of body composition were maintained in the long term .", "However , the intervention needs to be optimized to increase muscle strength and for long-term retention of effects on aerobic capacity ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Arterial and thromboembolic pulmonary hypertension ( PH ) lead to arterial hypoxaemia .", "To investigate whether cerebral tissue oxygenation ( CTO ) in patients with PH is reduced and whether this is associated with reduced exercise tolerance .", "16 patients with PH ( mean pulmonary arterial pressure 25 mmHg , 14 arterial , 2 chronic thromboembolic ) and 15 controls underwent right heart catheterisation with monitoring of CTO at rest , during maximal bicycle exercise and during inhalation of oxygen and NO .", "The 6 min walk distance ( 6MWD ) was measured .", "Median CTO in PH-patients at rest was 62 % ( quartiles 53 ; 71 ) , during exercise 60 % ( 53 ; 65 ) ; corresponding values in controls were 65 % ( 73 ; 73 ) ( P = NS ) and 68 % ( 66 ; 70 ) ( p = .013 vs. PH ) .", "Inhalation of NO and oxygen improved CTO in PH. In multivariate regression analysis CTO at maximal exercise predicted the work load achieved when controlled for age , pulmonary vascular resistance and mixed venous oxygen saturation ( R ( 2 ) = .419 , p < .000 ) ; in addition , the 6MWD was predicted by CTO ( adjusted R ( 2 ) = .511 , p < .000 ) .", "In PH-patients but not in controls CTO decreased during exercise .", "Since CTO was an independent predictor of the work load achieved and the 6MWD cerebral hypoxia may contribute to exercise limitation in PH. Clinicaltrials.gov : NCT01463514 ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "A lipid emulsion composed of soybean oil ( long-chain triglycerides , LCT ) , medium-chain triglycerides ( MCT ) and n-3 poly-unsaturated fatty acids ( PUFAs ) was evaluated for immune-modulation efficacy , safety , and tolerance in patients undergoing major surgery for gastric and colorectal cancer .", "In a prospective , randomized , double-blind study , 99 patients with gastric and colorectal cancer receiving elective surgery were recruited and randomly assigned to either the study group , receiving the n-3 PUFAs enriched intravenous fat emulsion ( IVFE ) , or the control group , receiving a lipid emulsion comprised of soybean oil and MCTs ( 0.8 - 1.5gkg-1day-1 ) as part of total parenteral nutrition ( TPN ) regimen from surgery ( day -1 ) up to post-operative day 7 .", "Safety and efficacy parameters were assessed on day -1 and post-operative visits on day 1 , 3 , and 7 .", "Adverse events were documented daily and compared between the groups .", "Pro-inflammatory markers , laboratory parameters , and adverse events did not differ prominently between the 2 groups , with the exception of net changes ( day 7 minus day -1 ) of free fatty acids ( FFAs ) , triglyceride , and high-density lipoprotein ( HDL ) .", "Net decrease of FFAs was remarkably higher in the study group , while the net increase of triglyceride and decrease of HDL was significantly lower .", "The n-3 PUFA-enriched IVFE showed improvements in lipid metabolism .", "In respect of efficacy , safety and tolerance both IVFE were comparable .", "In patients with severe stress , there is an inflammation-attenuating effect of n-3 PUFAs .", "Further , adequately powered clinical trials will be necessary to address this question in postsurgical GI cancer patients .", "US ClinicalTrials.gov NCT00798447 ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Butter is rich in saturated fat [ saturated fatty acids ( SFAs ) ] and can increase plasma low density lipoprotein ( LDL ) cholesterol , which is a major risk factor for cardiovascular disease .", "However , compared with other dairy foods , butter is low in milk fat globule membrane ( MFGM ) content , which encloses the fat .", "We hypothesized that different dairy foods may have distinct effects on plasma lipids because of a varying content of MFGM .", "We aimed to investigate whether the effects of milk fat on plasma lipids and cardiometabolic risk markers are modulated by the MFGM content .", "The study was an 8-wk , single-blind , randomized , controlled isocaloric trial with 2 parallel groups including overweight men and women ( n = 57 randomly assigned ) .", "For the intervention , subjects consumed 40 g milk fat/d as either whipping cream ( MFGM diet ) or butter oil ( control diet ) .", "Intervention foods were matched for total fat , protein , carbohydrates , and calcium .", "Subjects were discouraged from consuming any other dairy products during the study .", "Plasma markers of cholesterol absorption and hepatic cholesterol metabolism were assessed together with global gene-expression analyses in peripheral blood mononuclear cells .", "As expected , the control diet increased plasma lipids , whereas the MFGM diet did not [ total cholesterol ( SD ) : +0.30 0.49 compared with -0.04 0.49 mmol/L , respectively ( P = 0.024 ) ; LDL cholesterol : +0.36 0.50 compared with +0.04 0.36 mmol/L , respectively ( P = 0.024 ) ; apolipoprotein B : apolipoprotein A-I ratio : +0.03 0.09 compared with -0.05 0.10 mmol/L , respectively ( P = 0.007 ) ; and non-HDL cholesterol : +0.24 0.49 compared with -0.14 0.51 mmol/L , respectively ( P = 0.013 ) ] .", "HDL-cholesterol , triglyceride , sitosterol , lathosterol , campesterol , and proprotein convertase subtilisin/kexin type 9 plasma concentrations and fatty acid compositions did not differ between groups .", "Nineteen genes were differentially regulated between groups , and these genes were mostly correlated with lipid changes .", "In contrast to milk fat without MFGM , milk fat enclosed by MFGM does not impair the lipoprotein profile .", "The mechanism is not clear although suppressed gene expression by MFGM correlated inversely with plasma lipids .", "The food matrix should be considered when evaluating cardiovascular aspects of different dairy foods .", "This trial was registered at clinicaltrials.gov as NCT01767077 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To observe differences of therapeutic effect between acupuncture combined with bloodletting and regular western medication on chronic urticarial .", "One hundred and sixty patients were randomly divided into an acupuncture bloodletting group and a loratadine group , 80 cases in each group .", "In the acupuncture bloodletting group , Quchi ( LI 11 ) , Neiguan ( PC 6 ) , Xuehai ( SP 10 ) and Sanyinjiao ( SP 6 ) were selected and manipulated with reducing method , and pricking bloodletting with three-edge needle and cupping were given at Feishu ( BL 13 ) and Geshu ( BL 17 ) , once every other day .", "The oral administration of 10 mg loratadine was applied in the loratadine group , once a day .", "The therapeutic effect in two groups was observed and compared after four weeks .", "The cured and markedly effective rate was 91.3 % ( 73/80 ) in the acupuncture bloodletting group , which was similar to 81.3 % ( 65/80 ) in the loratadine group ( P > 0.05 ) .", "The scores of symptom-sign in the two groups were reduced after treatment ( 10.14 + / - 1.95 vs 2.12 + / - 40.32 , 10.30 + / - 1.82 vs 3.21 + / - 0.28 , both P < 0.01 ) , but there was no statistically significant difference between two groups after treatment ( P > 0.05 ) .", "There was no obvious adverse effect in the acupuncture bloodletting group while 3 cases of mild somnolence were reported in the loratadine group .", "The acupuncture bloodletting is an effective method for chronic urticarial , which has similar effect to loratadine without adverse effect ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Reducing the wound healing time is crucial in wound as it lowers the chance of infection and decreases complications and cost .", "Grape seed extract has the ability to release endothelial growth factor and its topical application results in contraction and closure of the skin wound .", "Furthermore , it possesses antioxidant and antibacterial properties .", "In several studies it has been proved effective in animals .", "Therefore , due to low side effects and recognition of herbal medicine , we decided to evaluate the effect of grape seed extract 2 % herbal cream on human skin lesions .", "This study is a double blind clinical trial conducted on two groups of treatment and placebo .", "Surgery was performed on skin lesions such as skin tags and moles which were found on the neck , trunk and limbs ( except for face ) .", "After enrollment and obtaining informed consent from participants , they were randomized into two groups of treatment and placebo .", "Excision of the lesions was done by surgical scissors .", "The lesions got restored by secondary intention method .", "After the first day of treatment , the patients were visited on the 3rd , 7th , 10th , 14th , and 21st day .", "Grape seed extract cream 2 % was produced and coded by the Faculty of Pharmacy , Ahvaz University of Medical Sciences .", "In order to compare the two groups , T-test was used .", "For time assessing , analysis of variance with repeated measures was employed .", "The results showed complete repair of wounds averagely on day 8 for the treatment group and on day 14 for the placebo group , which was clearly significant in terms of statistical difference ( p = 0.00 ) .", "Proanthocyanidins in grape seed extract trigger the release of vascular endothelial growth factor and its topical application causes wound contraction and closure .", "Curing skin lesions with grape seed extract caused proliferation areas with protected boundaries in epithelium , increased cell density and increased deposition of connective tissue at the wound site which in general improves cellular structure in wound .", "In addition , its anti-inflammatory and anti-microbial properties are effective in wound healing ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "We tested if an increase in immune activation and a decrease in CD4 T cells induced by different antigenic stimuli could be associated with changes in the thymic function and the interleukin ( IL ) -7 / CD127 system .", "Twenty-six HIV-infected patients under combined antiretroviral therapy ( cART ) were randomized to receive , during 12 months , a complete immunization schedule ( 7 vaccines and 15 doses ) or placebo .", "Thereafter , cART was interrupted during 6 months .", "Changes in the thymic function and the IL-7 / CD127 system after 3 different antigenic stimuli ( vaccines , episodes of low-level intermittent viremia before cART interruption , or viral load rebound after cART interruption ) were assessed .", "During the period on cART , neither vaccines nor low-level viremia influenced thymic function or IL-7 / CD127 system parameters .", "By analyzing the cohort as a whole while on cART , a significant improvement was observed in the thymic function as measured by an increase in the thymic volume ( P = 0.024 ) , T-cell receptor excision circle-bearing cells ( P = 0.012 ) , and naive CD4 and CD8 T cells ( P = 0.069 both ) .", "No significant changes were observed in the IL-7 / CD127 system .", "After cART interruption , a decrease in T-cell receptor excision circles ( P < 0.001 ) and naive CD8 T cells ( P < 0.001 ) , an increase in IL-7 and expression of CD127 on naive and memory CD4 T cells ( P = 0.028 , P = 0.088 , and P = 0.04 , respectively ) , and a significant decrease in CD127 on naive and memory CD8 T cells ( P = 0.01 , P = 0.006 , respectively ) were observed .", "Low-level transient antigenic stimuli during cART were not associated with changes in the thymic function or the IL-7 / CD127 system .", "Conversely , viral load rebound very early after cART interruption influenced the thymic function and the IL-7 / CD127 system .", "Clinical Trials.gov number NCT00329251 ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "We have previously shown that the PAM50-based risk of recurrence ( ROR ) score is significantly correlated with distant recurrence in both the translational research cohort within the Arimidex , Tamoxifen Alone or in Combination ( ATAC ) trial ( TransATAC ) and Austrian Breast and Colorectal Cancer Study Group 8 ( ABCSG 8 ) randomized trials .", "Here , we focus on the ROR score for predicting distant recurrence after 5 years of follow-up in a combined analysis of these two randomized trials .", "Long-term follow-up data and tissue samples were obtained from 2,137 postmenopausal women with hormone receptor-positive early-stage breast cancer from the ABCSG 8 and TransATAC trials .", "We used Cox proportional hazard regression models to determine the prognostic value of ROR for distant recurrence beyond 5 years in the combined data set .", "A total of 2,137 women who did not have a recurrence 5 years after diagnosis were included in the combined analyses .", "The Clinical Treatment Score ( CTS ) was the strongest prognostic factor 5 years after diagnosis ( univariable : likelihood ratio [ LR ] ( 2 ) = 94.12 , bivariable : LR ( 2 ) = 61.43 ) .", "The ROR score was significantly prognostic by itself in years 5 to 10 .", "In the node-negative/human epidermal growth factor receptor 2-negative subgroup , more prognostic value for late distant recurrence was added by the ROR score compared with the CTS .", "The ROR score added clinically meaningful prognostic information to the CTS in all patients and all subgroups in the late follow-up period .", "These results suggest that the ROR score may be helpful for separating patients into risk groups who could be spared or potentially benefit from extended hormonal therapy beyond 5 years of treatment ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "This study measured the effects of dietary supplementation with lipid-based nutrient supplements ( LNSs ) on 18-month-old children 's physical activity .", "In a randomised , controlled , outcome-assessor blinded trial 1932 six-month-old children from Malawi received one of five interventions daily from 6-18 months of age : 10-g milk-LNS , 20-g milk-LNS , 20-g non-milk-LNS , 40-g milk-LNS or 40-g non-milk-LNS , or received no intervention in the same period ( control ) .", "The control group received delayed intervention with corn-soy blend from 18-30 months .", "Physical activity was measured over 1 week by ActiGraph GT3X + accelerometer at 18 months .", "Main outcome was mean vector magnitude accelerometer counts/15s .", "Analyses were restricted to children with valid accelerometer data on at least 4 days with minimum 6h of wearing time per day .", "Of the 1435 children recruited to this substudy , 1053 provided sufficient data for analysis .", "The mean ( s.d. ) vector magnitude accelerometer counts in the total sample were 307 ( 64 ) .", "The difference ( 95 % CI ) in mean accelerometer counts , compared with the control group , was 8 ( -6 to 21 , P = 0.258 ) in 10-g milk-LNS , 3 ( -11 to 17 , P = 0.715 ) in 20-g milk-LNS , 5 ( -8 to 19 , P = 0.445 ) in 20-g non-milk-LNS , 10 ( -3 to 23 , P = 0.148 ) in 40-g milk-LNS and 2 ( -12 to 16 , P = 0.760 ) in 40-g non-milk-LNS groups .", "Provision of 10-40g doses of LNS daily for 12 months did not increase physical activity of Malawian toddlers ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To present the impact of treatments on health-related quality of life ( HRQoL ) from the double-blind , randomised phase III COMBI-d study that investigated the combination of dabrafenib and trametinib versus dabrafenib monotherapy in patients with BRAF V600E/K-mutant metastatic melanoma .", "COMBI-d showed significantly prolonged progression-free survival for the combination .", "HRQoL was evaluated using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 , a generic cancer questionnaire ( completed at baseline , during study treatment , at progression and post progression ) assessing various dimensions ( global health/QoL , functional status , and symptom impact ) .", "A mixed-model , repeated-measures analyses of covariance evaluated differences between arms .", "Questionnaire completion rates were > 95 % at baseline , > 85 % to week 40 and > 70 % at disease progression .", "Baseline scores across both arms were comparable for all dimensions .", "Global health dimension scores were significantly better at weeks 8 , 16 and 24 for patients receiving the combination during treatment and at progression .", "The majority of functional dimension scores ( physical , social , role , emotional and cognitive functioning ) trended in favour of the combination .", "Pain scores were significantly improved and clinically meaningful ( 6-13 point difference ) for patients receiving the combination for all follow-up assessments versus those receiving dabrafenib monotherapy .", "For other symptom dimensions ( nausea and vomiting , diarrhoea , dyspnoea , and constipation ) , scores trended in favour of dabrafenib monotherapy .", "This analysis demonstrates that the combination of dabrafenib and trametinib provides better preservation of HRQoL and pain improvements versus dabrafenib monotherapy while also delaying progression .", "( Clinicaltrials.gov registration number : NCT01584648 ) ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The treatment of large ( 10-25mm ) or giant ( 25mm ) cerebral aneurysms remains technically challenging , with a much higher complication and recanalization rate than that is observed for smaller aneurysms .", "The use of a flow diverter seems to facilitate the treatment of this special entity .", "In a previous single-center prospective study approved by the Ethics Committee and China Food and Drug Administration ( CFDA ) , we obtained promising results , showing remarkable safety and effectiveness for the Tubridge flow diverter .", "Nevertheless , the previous study may have been limited by biases due to its single-center design and limited number of subjects .", "Furthermore , although various articles have reported durable results from treating aneurysms using flow diverters , increasing questions have arisen about this form of treatment .", "Thus , prospective , multiple-center , randomized trials containing more subjects are needed .", "This study is a multicenter , randomized , controlled clinical trial comparing clinical outcomes for patients with unruptured large/giant intracranial aneurysms treated with either conventional stent-assisted coiling or flow diverter implantation .", "A total of 124 patients who fulfill the inclusion and exclusion criteria will be randomized into either a treatment group or a control group in the ratio of 1:1 .", "The treatment group will receive Tubridge implantation alone or combined with bared coils , and the control group will be treated with stent-assisted coiling ( bare coils ) .", "The primary endpoint will be the complete occlusion rate at 6-month follow-up .", "Secondary endpoints include the immediate technique success rate , overall mortality , adverse events ( ischemic stroke or intracranial bleeding ) within 30days , 90days and 1year post-operation , and the rate of intra-stent stenosis and thrombosis 6months post-operation .", "This prospective trial may provide more information on the safety and efficacy of the Tubridge flow diverter and may potentially change the strategy for treatment of large or giant aneurysms .", "The trial is registered on the Chinese Clinical Trial Registry : ChiCTR-TRC-13003127 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "CONCLUSIONS", "BACKGROUND" ]

[ "The prevalence of obesity in men in the UK is amongst the highest in Europe but men are less likely than women to use existing weight loss programmes .", "Developing weight management programmes which are appealing and acceptable to men is a public health priority .", "Football Fans in Training ( FFIT ) , a men-only weight management programme delivered to groups of men at top professional football clubs , encourages men to lose weight by working with , not against , cultural ideals of masculinity .", "To inform further development of interventions in football club settings , the current study explored who is attracted to FFIT and why overweight/obese men choose to take part .", "A mixed-methods study analysing baseline data on 747 men aged 35-65years with BMI28kg/m2 who were participants in a randomised controlled trial of FFIT , and data from 13 focus group discussions with 63 men who had attended the programme .", "Objectively-measured mean body mass index was 35.3 kg/m2 ( sd 4.9 ) .", "Overall over 90 % of participants were at very high or extremely high risk of future ill-health .", "Around three-quarters of participants in all age groups were at ` very high ' risk of type 2 diabetes , hypertension and cardiovascular disease ( 72 % , 73 % and 80 % of men aged 35-44 , 45-54 and 55-64years respectively ) .", "A further 21 % , 16 % and 13 % were at ` extremely high ' risk .", "Qualitative data revealed that the powerful ` draw ' of the football club attracted men otherwise reluctant to attend existing weight management programmes .", "The location and style of delivery of early FFIT sessions fostered team spirit ; men appreciated being with others ` like them ' and the opportunity to undertake weight management in circumstances that enhanced physical and symbolic proximity to something they valued highly , the football club .", "The delivery of a weight management intervention via professional football clubs attracted men at high risk of ill-health .", "The setting enabled men to join a weight management programme in circumstances that felt ` right ' rather than threatening to themselves as men .", "FFIT is an example of how to facilitate health promotion activities in a way that is consistent with , rather than challenging to , common ideals of masculinity ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To evaluate the efficacy of sequential enteral nutrition support in patients with severe cerebral stroke .", "Forty-nine patients with severe cerebral stroke met the inclusion criteria were randomly divided into sequential enteral nutrition group ( Group A , n = 24 ) and conventional enteral nutrition group ( Group B , n = 25 ) .", "Patients in Group A received short-peptide-based enteral nutrition support first , then gradually transferred to intact protein enteral nutrition .", "Meanwhile , patients in Group B constantly received intact protein enteral nutrition support .", "The nutritional indexes and the rate of complications were compared between two groups .", "The nutritional indexes were decreased in both groups within 4 weeks after admission , but the decreasing levels of hemoglobin and albumin in Group A were significantly lower than those in Group B ( P < 0.05 ) , and the incidence of infections and gastrointestinal hemorrhage in Group A was also lower than that in Group B ( P < 0.05 ) .", "However , there were no significant differences in body weight , BMI , triceps skinfold thickness , biceps circumference , arm muscle circumference between two groups ( P > 0.05 ) .", "Sequential enteral nutritional support can improve the nutritional status and decrease the incidence of complications in critical patients with cerebral stroke ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "There are no effective and safe treatments for chronic hepatitis C virus ( HCV ) infection of patients who have advanced liver disease .", "In this phase 2 , open-label study , we assessed treatment with the NS5A inhibitor ledipasvir , the nucleotide polymerase inhibitor sofosbuvir , and ribavirin in patients infected with HCV genotypes 1 or 4 .", "Cohort A enrolled patients with cirrhosis and moderate or severe hepatic impairment who had not undergone liver transplantation .", "Cohort B enrolled patients who had undergone liver transplantation : those without cirrhosis ; those with cirrhosis and mild , moderate , or severe hepatic impairment ; and those with fibrosing cholestatic hepatitis .", "Patients were assigned randomly ( 1:1 ) to receive 12 or 24 weeks of a fixed-dose combination tablet containing ledipasvir and sofosbuvir , once daily , plus ribavirin .", "The primary end point was sustained virologic response at 12 weeks after the end of treatment ( SVR12 ) .", "We enrolled 337 patients , 332 ( 99 % ) with HCV genotype 1 infection and 5 ( 1 % ) with HCV genotype 4 infection .", "In cohort A ( nontransplant ) , SVR12 was achieved by 86 % -89 % of patients .", "In cohort B ( transplant recipients ) , SVR12 was achieved by 96 % -98 % of patients without cirrhosis or with compensated cirrhosis , by 85 % -88 % of patients with moderate hepatic impairment , by 60 % -75 % of patients with severe hepatic impairment , and by all 6 patients with fibrosing cholestatic hepatitis .", "Response rates in the 12-and 24-week groups were similar .", "Thirteen patients ( 4 % ) discontinued the ledipasvir and sofosbuvir combination prematurely because of adverse events ; 10 patients died , mainly from complications related to hepatic decompensation .", "The combination of ledipasvir , sofosbuvir , andribavirin for 12 weeks produced high rates of SVR12 in patients with advanced liver disease , including those with decompensated cirrhosis before and after liver transplantation .", "ClinTrials.gov : NCT01938430 ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Secondary peritonitis is an advanced form of complicated intra-abdominal infection ( cIAI ) requiring hospitalization , surgical source control , and empiric antibiotic therapy against causative aerobic and anaerobic bacteria .", "This pooled analysis of four prospective , active-controlled randomized clinical trials compared the efficacy and safety of moxifloxacin with that of comparator antibiotics in patients with confirmed secondary peritonitis .", "The primary efficacy endpoint was clinical success rate at test-of-cure ( TOC ) between day 10 and 45 post-therapy in the per-protocol ( PP ) population .", "Safety and clinical efficacy were assessed also in the intent-to-treat population ( ITT ) .", "Bacteriological success was assessed at TOC in the microbiologically-valid population as a secondary efficacy endpoint .", "Overall clinical success rates at TOC were 85.3 % ( 431 of 505 patients ) in the moxifloxacin and 88.4 % ( 459 of 519 patients ) in the comparator treatment groups ( PP population , point estimate for the difference in success rates : -3.0 % ; 95 % CI -7.06 % , 1.05 % ) , respectively .", "Similar clinical success rates between moxifloxacin and comparators were observed by anatomical site of infection , and ranged from 80.6 % to 100 % for moxifloxacin and from 71.4 % to 96.6 % for comparators , respectively .", "Bacteriologic success rates were similar with moxifloxacin ( 82.4 % ) and comparators ( 86.8 % ) , respectively .", "The proportion of patients experiencing any treatment-emergent adverse events was slightly higher with moxifloxacin ( 67.3 % ) versus comparators ( 59.8 % ) .", "Rates of drug-related adverse events ( 20.9 % versus 20.0 % ) and deaths ( 4.3 % versus 3.4 % ) were similar in moxifloxacin and comparator groups ; none of the deaths were drug-related .", "The data suggests that once-daily IV ( or IV/PO ) moxifloxacin has a comparable efficacy and safety profile to antibiotic regimens approved previously in the subgroup of patients with secondary peritonitis of mild-to-moderate severity ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "International geographic differences in outcomes may exist for clinical trials of heart failure and reduced ejection fraction ( HF-REF ) , but there are few data for those with preserved ejection fraction ( HF-PEF ) .", "We analyzed outcomes by international geographic region in the Irbesartan in Heart Failure with Preserved systolic function trial ( I-Preserve ) , the Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity ( CHARM ) - Preserved trial , the CHARM-Alternative and CHARM-Added HF-REF trials , and the Controlled Rosuvastatin Multinational Trial in HF-REF ( CORONA ) .", "Crude rates of heart failure hospitalization varied by geographic region , and more so for HF-PEF than for HF-REF .", "Rates in patients with HF-PEF were highest in the United States/Canada ( HF hospitalization rate 7.6 per 100 patient-years in I-Preserve ; 8.8 in CHARM-Preserved ) , intermediate in Western Europe ( 4.8 / 100 and 4.7 / 100 ) , and lowest in Eastern Europe/Russia ( 3.3 / 100 and 2.8 / 100 ) .", "The difference between the United States/Canada versus Eastern Europe/Russia persisted after adjustment for key prognostic variables : adjusted hazard ratios 1.34 ( 95 % confidence interval , 1.01-1 .74 ; P = 0.04 ) in I-Preserve and 1.85 ( 95 % confidence interval , 1.17-2 .91 ; P = 0.01 ) in CHARM-Preserved .", "In HF-REF , rates of HF hospitalization were slightly lower in Western Europe compared with other regions .", "For both HF-REF and HF-PEF , there were few regional differences in rates of all-cause or cardiovascular mortality .", "The differences in event rates observed suggest there is international geographic variation in 1 or more of the definition and diagnosis of HF-PEF , the risk profile of patients enrolled , and the threshold for hospitalization , which has implications for the conduct of future global trials ." ]

[ "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To compare immediately loaded post-extractive single implants using a definitive abutment versus provisional abutment later replaced by custom-made abutment .", "In two private clinics , 28 patients in need of one single post-extractive implant in the maxilla or mandible from the left second premolar to the right second premolar area were randomised shortly before tooth extraction to provisional abutment ( PA ) and definitive abutment ( DA ) groups .", "Three patients had to be excluded for buccal wall fracture after tooth extraction .", "In the PA group , implants were immediately restored using a platform-switched provisional titanium abutment and definitive platform-switched titanium abutments were used in the DA group .", "In both groups , a non-occluding provisional single crown was provided .", "Implants were definitively restored after 4 months .", "In the PA group , the abutment was removed and the impression was made directly on the implant platform .", "In the DA group an impression of the abutment was made using a retraction cord .", "Outcome measures were : implant failures ; complications ; and marginal peri-implant bone level changes .", "Patients were followed up to 1 year after loading .", "Twelve patients were randomised to the DA group and 13 patients to the PA group .", "At the 12-month follow-up , no implant failed .", "One biological complication occurred in the DA group and one mechanical complication occurred in the PA group .", "All complications were successfully treated .", "One year after loading , implants in the DA group lost an average of 0.11 mm ( SD : 0.06 ) of periimplant bone and implants in PA group about 0.58 mm ( SD : 0.11 ) .", "At the 12-month follow-up , there was a statistically significant difference in bone level change between groups ( mean difference : 0.48 mm , CI 95 % 0.40 ; 0.55 , P < 0.0001 ) .", "Within the limits of this study , the non-removal of abutments placed at the time of surgery resulted in the maintenance of 0.5 mm more bone levels around immediately restored postextractive single implants than repeated abutment removal , although this amount of bone maintenance may not have a clinical impact .", "Conflicts of interest notification : Dr Tommaso Grandi and Dr Paolo Guazzi serve as consultants for JDentalCare .", "This study was completely self-financed and no funding was sought or obtained , not even in the form of free materials ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To compare clinical profiles of Shang Ring versus conventional circumcisions .", "Parallel group open-label randomized controlled trial with one-to-one allocations in 2 sites .", "We enrolled HIV-negative men aged 18-54 years in Homa Bay , Kenya , and Lusaka , Zambia and followed them at 2 , 7 , 14 , 21 , 28 , 42 , and 60 days after Shang Ring versus conventional circumcision .", "We compared the duration of surgery , postoperative pain using a visual analog scale , adverse events rates , time to complete wound healing by clinical assessment , participant acceptability , and provider preferences between circumcision groups .", "We randomized 200 men to each group ; 197 and 201 contributed to the Shang Ring and conventional surgery analyses , respectively .", "Adverse event rates were similar between groups .", "Pain scores at most time points were similar , however , the Shang Ring group reported higher scores for worst pain during erections ( 3.5 1.9 vs. 2.3 1.7 ; P < 0.001 ) .", "Significantly more men were satisfied with the cosmetic appearance following Shang Ring male circumcision ( MC ) , 95.7 % versus 85.9 % ( P = 0.02 ) in Kenya , and 96.8 % versus 71.3 % ( P < 0.01 ) in Zambia .", "Although median time to complete wound healing was 43 days in both groups , conventional circumcisions healed on average 5.2 days sooner ( P < 0.001 ) .", "Shang Ring procedures took one-third the time of conventional MC , 7 versus 20 minutes .", "All circumcision providers preferred the Shang Ring .", "Safety profiles of the 2 techniques were similar , all MC providers preferred the Shang Ring technique , and study participants preferred the Shang Ring 's cosmetic results .", "The Shang Ring should be considered for adult MC as programs scale-up ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "In spite of widespread use of nasal CPAP there are comparatively few studies to guide the choice of nasal prongs .", "To determine whether the Fisher & Paykel Healthcare ( FPH ) neonatal continuous positive airway pressure ( CPAP ) interface was effective in providing bubble CPAP when compared to the Hudson prong interface .", "The study was a randomized cross-over study of twenty newborn infants 500 g or more requiring CPAP for respiratory support at birth .", "Infants were randomized to either the Fisher & Paykel Healthcare or Hudson CPAP interface for twenty four hours .", "Crossover between interfaces occurred after subsequent twenty four hour periods .", "The primary outcome was the provision of desired CPAP pressures , defined as provision of CPAP within one cm H2O of set pressure .", "The percentage time CPAP was within one cm H2O of set pressure was 66.5 % for the Hudson and 71.8 % for the FPH interface ( p = 0.66 ) .", "Oxygen saturations for the Hudson interface were in target range for a median of 97.8 % of the time , and , with the FPH interface , for a median of 98.2 % of the time ( p = 0.76 ) .", "Clinically significant differences in primary or secondary outcomes between the two groups were not detected .", "The nasal CPAP interfaces studied were equally effective in achieving desired bubble CPAP pressures and target saturations ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To determine the impact of music intervention on endothelial function , hemodynamics , and patient anxiety before , during , and after cardiac catheterization .", "The effect of music therapy during cardiac catheterization on endothelial function and patient satisfaction has received limited study .", "Seventy patients undergoing elective cardiac catheterization were randomized to music therapy ( n = 36 ) or no music therapy ( n = 34 ) .", "Peripheral arterial tonometry was performed before and after catheterization .", "A 6 item ( 24-point scale ) questionnaire evaluating patient anxiety and discomfort levels was also administered after the procedure .", "Both study groups had similar baseline characteristics , fluoroscopy time , and contrast administration .", "Reactive hyperemia index ( RHI ) change was 0.14 0.72 in the music group and 0.30 0.58 in the control group ( P = .35 ) .", "Systolic and diastolic blood pressure ( BP ) changes did not significantly differ between the two groups ( systolic BP change -3.3 17.3 mm Hg vs -2.3 19.4 mm Hg ; P = .83 and diastolic BP change -1.9 12.2 mm Hg vs. 2.0 13.4 mm Hg ; P = .23 ) .", "Heart rate changes were also comparable between the two groups ( -1 6 beats / min vs -1 7 beats/min ; P = .22 ) .", "Patient satisfaction questionnaire measurements were found to be similar in patients with and without music therapy ( 8 [ 7-11 ] vs 9 [ 8-12 ] ; P = .36 ) .", "In this study , music intervention did not elicit a vasodilator response , did not lower blood pressure or heart rate , and did not relieve anxiety or stress discomfort in patients who underwent coronary angiography ." ]

[ "OBJECTIVE", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "The perineal wound is a major source of morbidity after abdominoperineal resection ( APR ) for rectal cancer , particularly after preoperative irradiation .", "Myocutaneous flap reconstruction is a viable alternative to primary perineal wound repair providing well-vascularized non-irradiated tissue to fill the dead space , and improve wound healing .", "Sixty patients with low rectal cancer receiving neoadjuvant radiotherapy were prospectively randomized to either primary perineal wound closure ( Group B ) or VRAM perineal reconstruction ( Group A ) .", "The study was carried out in the surgical department , National Cancer Institute ( NCI ) , Cairo University over a period of 4 years from August 2008 to July 2012 .", "All patients were evaluated as regards incidence of perineal wound complications , abdominal wall complications , and added co-morbidity .", "Perineal wound complications were observed in 5 patients in group A ( 17.2 % ) and in 14 patients in group B ( 46.4 % ) ( P = 0.015 ) .", "There was no significant difference in the incidence of abdominal wound morbidity between both groups .", "Operative blood loss and time were lower in group B.", "The vertical rectus myocutaneous flap ( VRAM ) is a relatively simple and reliable technique for perineal wound reconstruction after abdominoperineal resection ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Quantifying pediatric immunologic recovery by highly active antiretroviral therapy ( HAART ) initiation at different CD4 percentage ( CD4 % ) and age thresholds may inform decisions about timing of treatment initiation .", "HIV-1-infected , HAART-naive children in Europe and the Americas were followed from 2002 through 2009 in PENPACT-1 .", "Data from 162 vertically infected children , with at least World Health Organization `` mild '' immunosuppression and CD4 % < 10th percentile , were analyzed for improvement to a normal CD4 % ( 10th percentile ) within 4 years after HAART initiation .", "Data from 209 vertically infected children , regardless of immune status , were analyzed for CD4 % outcomes at 4 years and viral failure within 4 years .", "Seventy-two percent of baseline immunosuppressed children recovered to normal within 4 years .", "Compared with `` severe '' immunosuppression , more children with `` mild '' immunosuppression ( difference 36 % , 95 % confidence interval [ CI ] : 22 % to 49 % ) or `` advanced '' immunosuppression ( difference 20.8 % , 95 % CI : 5.8 % to 35.9 % ) recovered a normal CD4 % .", "For each 5-year increase in baseline age , the proportion of children achieving a normal CD4 % declined by 19 % ( 95 % CI : 11 % to 27 % ) .", "Combining baseline CD4 % and age effects resulted in > 90 % recovery when initiating HAART with `` mild '' immunosuppression at any age or `` advanced '' immunosuppression at age < 3 years .", "Baseline CD4 % effects became greater with increasing age ( P = .02 ) .", "At 4 years , most immunologic benefits were still significant but diminished .", "Viral failure was highest in infancy ( 56 % ) and adolescence ( 63 % ) .", "Initiating HAART at higher CD4 % and younger ages maximizes potential for immunologic recovery .", "Guidelines should weigh immunologic benefits against long-term risks ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To evaluate and compare the visual , refractive , contrast sensitivity , and aberrometric outcomes with a diffractive bifocal and trifocal intraocular lens ( IOL ) of the same material and haptic design .", "Sixty eyes of 30 patients undergoing bilateral cataract surgery were enrolled and randomly assigned to one of two groups : the bifocal group , including 30 eyes implanted with the bifocal diffractive IOL AT LISA 801 ( Carl Zeiss Meditec , Jena , Germany ) , and the trifocal group , including eyes implanted with the trifocal diffractive IOL AT LISA tri 839 MP ( Carl Zeiss Meditec ) .", "Analysis of visual and refractive outcomes , contrast sensitivity , ocular aberrations ( OPD-Scan III ; Nidek , Inc. , Gagamori , Japan ) , and defocus curve were performed during a 3-month follow-up period .", "No statistically significant differences between groups were found in 3-month postoperative uncorrected and corrected distance visual acuity ( P .21 ) .", "However , uncorrected , corrected , and distance-corrected near and intermediate visual acuities were significantly better in the trifocal group ( P < .01 ) .", "No significant differences between groups were found in postoperative spherical equivalent ( P = .22 ) .", "In the binocular defocus curve , the visual acuity was significantly better for defocus of -0.50 to -1.50 diopters in the trifocal group ( P .04 ) and -3.50 to -4.00 diopters in the bifocal group ( P .03 ) .", "No statistically significant differences were found between groups in most of the postoperative corneal , internal , and ocular aberrations ( P .31 ) , and in contrast sensitivity for most frequencies analyzed ( P .15 ) .", "Trifocal diffractive IOLs provide significantly better intermediate vision over bifocal IOLs , with equivalent postoperative levels of visual and ocular optical quality ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Higher heart rate is associated with poorer outcomes in patients with heart failure and reduced ejection fraction ( HF-REF ) .", "Less is known about the association between heart rate and outcomes in patients with heart failure and preserved ejection fraction ( HF-PEF ) .", "Therefore , we examined the relationship between heart rate and outcomes in the irbesartan in patients with heart failure and preserved systolic function trial ( I-Preserve ) in patients with an ejection fraction > 45 % aged > 60 years .", "Heart rate was analysed as both a categorical ( tertiles ) and continuous variable .", "Patients in sinus rhythm ( n = 3271 ) and atrial fibrillation ( n = 696 ) were analysed separately .", "The outcomes examined were the primary endpoint of the trial ( all-cause death or cardiovascular hospitalization ) , the composite of cardiovascular death or heart failure hospitalization ( and its components ) and all-cause death alone .", "Higher heart rate was associated with a significantly higher risk of all outcomes studied for patients in sinus rhythm , even after adjustment for other prognostic variables , including N-terminal pro-B-type natriuretic peptide .", "Each standard deviation ( 12.4 bpm ) increase in heart rate was associated with an increase in risk of 13 % for cardiovascular death or heart failure hospitalization ( P = 0.002 ) .", "No relationship between heart rate and outcomes was observed for patients in atrial fibrillation .", "Beta-blocker treatment did not reduce the heart rate-risk relationship .", "In patients with heart failure and preserved ejection fraction , heart rate is in sinus rhythm an independent predictor of adverse clinical outcomes and might be a therapeutic target in this syndrome .", "Clinical Trial Registration - URL http://www.clinicaltrials.gov .", "Unique identifier : NCT 0095238 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To observe the effect of warm-reinforcing needling combined with modern rehabilitation training on motor function of cerebral palsy ( CP ) children .", "Sixty cases of CP children were randomly divided into acupuncture combined with rehabilitation ( Acu + Rehab , n = 30 ) group and Rehab ( n = 30 ) group .", "Patients of the Acu + Rehab group were treated by warm-reinforcing needling stimulation of Jiaji ( EX-B 2 ) , Jianyu ( LI 15 ) , Quchi ( LI 11 ) , Hegu ( LI 4 ) , Zusanli ( ST 36 ) , Yinlingquan ( GB 34 ) , Sanyinjiao ( SP 6 ) , Juegu ( GB 39 ) , Yanglingquan ( GB 34 ) , etc. , combined with Bobath rehabilitation therapy , and those of the Rehab group treated by Bobath rehabilitation ( stimulating key control points in the body , triggering reflexes that provide head and body control ) .", "The treatment was conducted every day , with three months being a therapeutic course , two courses in all .", "The Peabody Developmental Motor Scales 2 ( PDMS-2 ) was used to evaluate the CP children 's motor function [ 1 ) gross motor : posture ( straightness ratio ) , locomotion and object manipulation ; 2 ) fine motor : grasping and visual-Motor integration ] .", "After the treatment , of the 30 and 30 cases in the Acu + Rehab and Rehab groups , 1 ( 3.33 % ) and 0 ( 0 % ) were cured , 20 ( 66.67 % ) and 18 ( 60.00 % ) experienced marked improvement , 9 ( 30.00 % ) and 12 ( 40.00 % ) were invalid , with the effective rates being 70.00 % and 60.00 % respectively .", "The therapeutic effect of the Acu + Rehab group was markedly superior to that of the Rehab group ( P < 0.05 ) .", "After 6 months ' treatment , the scores of posture , locomotor , object manipulation and grasping , and visual-movement integration were significantly increased in comparison with pre-treatment in the same one group ( P < 0.05 ) , and the effects of the Acu + Rehab group were obviously superior to those of Rehab group in increasing the scores of posture , locomotor , object manipulation and grasping after 6 months ' treatment ( P < 0.05 ) .", "Warm-reinforcing needling combined with Bobath rehabilitation has a better therapeutic effect in improving gross motor and fine motor functions of CP children ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Data were obtained through a multisite clinical trial in which different types of genetic risk-related information were disclosed to individuals ( n = 246 ) seeking a risk assessment for Alzheimer 's disease .", "Six weeks after disclosure , 83 % of participants correctly recalled the number of risk-increasing APOE alleles they possessed , and 74 % correctly recalled their APOE genotype .", "While 84 % of participants recalled their lifetime risk estimate to within 5 percentage points , only 51 % correctly recalled their lifetime risk estimate exactly .", "Correct recall of the number of APOE risk-increasing alleles was independently associated with higher education ( p < 0.001 ) , greater numeracy ( p < 0.05 ) and stronger family history of Alzheimer 's disease ( p < 0.05 ) .", "Before adjustments for confounding , correct recall of APOE genotype was also associated with higher education , greater numeracy and stronger family history of Alzheimer 's disease , as well as with higher comfort with numbers and European American ethnicity ( all p < 0.05 ) .", "Correct recall of the lifetime risk estimate was independently associated only with younger age ( p < 0.05 ) .", "Recall of genotype-specific information is high , but recall of exact risk estimates is lower .", "Incorrect recall of numeric risk may lead to distortions in understanding risk .", "Further research is needed to determine how best to communicate different types of genetic risk information to patients , particularly to those with lower educational levels and lower numeracy .", "Health-care professionals should be aware that each type of genetic risk information may be differentially interpreted and retained by patients and that some patient subgroups may have more problems with recall than others ." ]

[ "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Selexipag is a novel , oral , selective prostacyclin ( PGI2 ) receptor agonist in clinical development for the treatment of pulmonary arterial hypertension .", "Film-coated tablets with strength between 200 and 1,600 g were used .", "Bioequivalence between 8 x 200 g and a new 1,600 g tablet was evaluated at steady state in healthy male subjects .", "This was an open-label , 2-treatment , 2-period , crossover , up-titration , phase 1 study .", "The treatments were selexipag at 1,600 g b.i.d. for 4.5 days either as 8 x 200 g tablets ( reference : A ) or 1 x 1,600 g tablet ( test : B ) , both preceded by an up-titration phase starting from 400 g b.i.d. doses , in 200-g steps every 4th day .", "Subjects were randomized 1 : 1 to the A-B or B-A sequence .", "The pharmacokinetics and tolerability of selexipag and its active metabolite , ACT-333679 , were investigated .", "80 subjects were enrolled in the study : 65 subjects completed the study according to protocol , and 15 subjects withdrew from the study .", "The most frequent adverse events ( AEs ) were headache ( 86 % ) , myalgia ( 73 % ) , and jaw pain ( 73 % ) .", "There was no difference in nature and overall frequency of AEs between the two treatments .", "Steady state was attained within 3 days of the selexipag 1,600 g b.i.d.", "The 90 % confidence intervals ( CIs ) of the geometric mean ratio ( B/A ) at steady state for AUC and Cmax , ss were within ( 0.80 , 1.25 ) bioequivalence interval : ( 0.92 , 1.06 ) and ( 0.95 , 1.14 ) , respectively , for selexipag and ( 0.95 , 1.06 ) and ( 0.94 , 1.07 ) , respectively , for the active metabolite , ACT-333679 .", "Bioequivalence was demonstrated between 8 x 200 g and 1 x 1,600 g selexipag at steady state ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "METHODS", "CONCLUSIONS" ]

[ "The PASI score , the most common outcome measure in clinical trials of psoriasis treatment , is a non-linear scale that does not allow reliable assessment of subtle variations of its components ( erythema , induration , and desquamation ) .", "Highlight treatment response patterns potentially hidden by PASI score 's compounded weighted-average calculation .", "Patients with moderate-to-severe psoriasis enrolled in the phase-3 , 16-week , randomized CHAMPION study , and received adalimumab , methotrexate , or placebo .", "PASI scores were assessed post hoc for improvement , by body region and component .", "At Week 16 , a significantly greater percentage of adalimumab-treated patients vs methotrexate - and placebo-treated patients , achieved PASI 75 , PASI 90 and PASI 100 response in each body region and component .", "55.7 % of adalimumab-treated patients reached PASI 100 response in the head and neck region vs 16.7 % overall .", "Two key components of PASI , induration and desquamation , were affected by treatment more than erythema , the third component .", "Adalimumab was particularly effective in complete resolution of induration ( 44.9 % of patients ) vs methotrexate ( 10.9 % ) .", "For all PASI body regions and components , mean percent improvement in score at Weeks 2 , 4 , 8 , 12 , and 16 was significantly greater ( P < 0.05 ) for adalimumab treatment vs methotrexate or placebo .", "Adalimumab therapy resulted in complete resolution of individual body regions in at least 30.6 % up to 55.7 % of patients in CHAMPION .", "This was more than twice that of methotrexate and placebo .", "PASI improvement by body region is a novel and an important patient-relevant outcome worthy of reporting in future studies ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Progression of Parkinson 's disease ( PD ) is frequently characterized by the occurrence of freezing of gait ( FOG ) representing a disabling motor complication .", "We aim to investigate safety and efficacy of transcranial direct current stimulation of the primary motor cortex of PD patients with FOG .", "In this cross-over , double-blind , sham-controlled study , 10 PD patients with FOG persisting in `` on '' state underwent anodal and sham direct current stimulation for 5 consecutive days .", "Clinical assessment over a 1-month period was performed .", "A significant improvement of gait , as assessed by the Stand Walk Sit test , with reduction in number and duration of FOG episodes , along with a significant reduction in the Unified Parkinson 's Disease Rating Scale score , were observed after anodal stimulation .", "Beneficial effects were more evident after the entire 5-day stimulation session , and persisted until the end of the observation period .", "Anodal transcranial direct current stimulation of the motor cortex is safe and has therapeutic potential in PD patients with FOG ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Many patients who are candidates for implantable cardioverter defibrillators ( ICDs ) are not referred for potential implantation .", "We sought to determine if a simple provider reminder would increase referrals .", "We identified consecutive patients from January 2007 through July 2010 in the VA Palo Alto Health Care System with a left ventricular ejection fraction < 35 % on echocardiography .", "Patients were excluded using available administrative data only ( no chart review ) if they were known to have an ICD , if they were 80 years old , or if they did not have a current primary care or cardiology provider within the system .", "We randomized patients to no intervention or a clinical note to the provider in the medical record .", "The outcomes were referral for consideration of defibrillator implantation ( primary ) and documented discussion ( secondary ) .", "Of 330 patients with left ventricular ejection fraction35 % , 128 were known to have an ICD , 85 were no longer followed in the healthcare system , and 28 were 80 years old , leaving 89 patients to be randomized .", "Forty-six patients were randomized to intervention and 43 to control .", "Eleven of 46 ( 24 % ) intervention patients were referred for consideration of ICD implantation during the following 6 months versus 1 of 43 ( 2 % ) control patients ( P = 0.004 ) .", "Overall , 31 of 46 ( 67 % ) intervention patients versus 19 of 43 ( 44 % ) control patients had documentation discussing potential candidacy for defibrillators ( P = 0.05 ) .", "In patients with low left ventricular ejection fraction , a simple electronic medical record-based intervention directed to their providers improved the rates of referral for ICD implantation .", "URL : http://www.clinicaltrials.gov .", "Unique identifier : NCT01217827 ." ]

[ "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "The existing research findings regarding the effects of lemongrass ( Cymbopogon citratus ) tea on renal function indices are conflicting and inconclusive .", "In the present study , we investigated the effects of infusions prepared from C citratus leaves on creatinine clearance rate ( CCr ) and estimated glomerular filtration rate ( eGFR ) in humans .", "One hundred five subjects ( 55 men and 50 women ) aged 18 to 35years were randomly assigned to groups set to orally receive infusions prepared from 2 , 4 , or 8g of C citratus leaf powder once daily , for 30days .", "Serum and urinary levels of urea , creatinine , pH , specific gravity , uric acid , electrolytes , diuretic indices , and eGFR were assessed at days 0 , 10 , and 30 after the initiation of treatment .", "Results obtained on days10 and 30 were compared with baseline values .", "CCr and eGFR decreased significantly at day 30 in both male and female subjects in all the groups and in females treated with infusion prepared from 8g of C citratus leaf powder for 10days .", "At day 10 , CCr and eGFR were unchanged in those treated with infusions prepared from 2 or 4g of the leaf powder , whereas diuretic indices ( urine volume , urination frequency , diuretic action , and saliuretic indices ) increased above the baseline levels .", "Serum and urinary creatinine levels significantly increased ( P < .05 ) in both male and female subjects in all the groups .", "Serum urea significantly increased in the groups treated with infusions prepared from 4 or 8g of the leaf powder ( P < .05 ) for 30days .", "Serum electrolytes remained unchanged , but their urinary levels increased .", "We observed dose - and time-dependent adverse effects of C citratus on CCr and eGFR .", "At a high dose or with prolonged treatment with a low dose , eGFR decrease may be followed by a decline in the other renal function indices ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Treatment of complex fractures of the distal femur utilizing monoaxial locking plates ( e.g. Less Invasive Stabilisation System , LISS , Synthes ) is considered to be superior to conventional plating systems .", "Due to the limitation that the thread forces the screw into pre-determined positions , modifications have been made to allow screw positioning within a range of 30 ( Non Contact Bridging , NCB-DF , Zimmer ) .", "For the first time , this multicenter prospective randomized clinical trial ( RCT ) investigates the outcome of LISS vs. NCB-DF treatment following complex fractures of the distal femur .", "Since June 2008 , 27 patients with a fracture of the distal femur ( AO ASIF 33-A-C and periprosthetic fractures ) were enrolled in this study by four university trauma centres in southern Germany .", "Clinical ( e.g. range of motion , Oxford knee score , Tegner score ) and radiological ( e.g. axis deviation , secondary loss of realignment ) follow-ups were conducted one and six weeks , as well as three , six , and 12 months after the operation .", "This study comprises data of 27 patients ( 8 male , 19 female ; 15 NCB-DF , 12 LISS ) .", "Polyaxial osteosynthesis using the NCB system tended to result in better functional knee scores and a higher range of motion .", "Interestingly , fracture union tended to be more rapid using the polyaxial plating system .", "We present the analysis of a multicenter prospective RCT to compare the monoaxial LISS vs. the polyaxial NCB-DF treatment following complex fractures of the distal femur .", "NCB-DF treatment tended to result in better functional and radiological outcomes than LISS treatment .", "Level I." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "METHODS" ]

[ "Hemodynamic stability is one of the most critical concerns during induction of anesthesia .", "Whether the pharmacokinetic model by Marsh or the one by Schnider will produce better hemodynamic stability remains unclear .", "This study compared hemodynamic changes during induction between the two models .", "60 patients who underwent elective surgery were randomly assigned to plasma target-controlled infusion by Marsh 's ( n = 30 ) or Schnider 's ( n = 30 ) model with an initial target concentration of 4 gmL-1 .", "The target was then reset and gradually titrated to a sedation level with a narcotrend index ( NI ) below 64 .", "Stroke volume , cardiac output , systemic vascular resistance , arterial pressure , target , and effect site concentration , and dose of propofol infused were recorded every minute during the first 25 minutes of infusion .", "Throughout the first 25 minutes , stroke volume index and cardiac index were decreased significantly in both Marsh and Schnider groups , but no statistical difference was detected between the groups ( p > 0.05 ) .", "Central venous pressure ( CVP ) , systemic vascular resistance index ( SVRI ) , and heart rate ( HR ) did not significantly change during induction ( p > 0.05 ) .", "Time to loss of responsiveness ( LOR ) , and time for NI to decrease to 64 was faster in Marsh than in Schnider ( 1.51 0.8 minutes vs. 2.8 1.2 min , p < 0.001 ; 3.3 2.0 minutes vs. 5.2 2.3 minutes , p < 0.01 , respectively ) .", "When target concentrations are titrated according to NI during induction of anesthesia , Marsh 's model could induce sedation faster than Schnider 's .", "Meanwhile , hemodynamic changes were not observed to be statistically different between the two models .", "Hypotension induced by plasma target-controlled infusion of propofol could mainly be attributed to decreased stroke volume instead of vascular dilation ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The effects of box shape -- specifically width and height -- on the perception of heaviness were evaluated during individual and team lifting .", "Large objects are perceived to be as much as 50 % lighter than smaller objects with the same mass .", "This size-weight illusion presents an obvious risk when lifting large and heavy boxes .", "Recent research has shown that shape influences this illusion .", "Specifically , increases in length and width do not produce identical decreases in perceived heaviness .", "However , this effect has been documented only in individual lifting , mostly with small objects .", "Individuals and teams lifted large boxes and reported their perceptions of heaviness .", "The mass , height , and width of the boxes were varied independently to determine their unique effects on perceived heaviness .", "For both types of lift , increasing width produced a greater mean illusory drop ( expressed as a percentage decrease with 95 % confidence intervals ) in perceived heaviness ( 24 + / - 7 % during individual lifting and 41 + / - 8 % during team lifting ) than increasing height ( 15 + / - 7 % during individual lifting and 18 + / - 8 % during team lifting ) .", "Size and shape are important factors in perceiving the heaviness of boxes during both individual and team lifting .", "To avoid misperceiving weight and risking injury , lifters should be careful when approaching larger ( especially wider ) boxes ." ]

[ "OBJECTIVE", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Primary hyperparathyroidism ( PHPT ) is diagnosed by the presence of hypercalcemia and elevated or nonsuppressed parathyroid hormone ( PTH ) levels .", "Although surgery is usually curative , some individuals fail or are unable or unwilling to undergo parathyroidectomy .", "In such individuals , targeted medical therapy may be of value .", "Cinacalcet normalized calcium level and lowered PTH in patients with PHPT in several phase 2 and open-label studies .", "We compared cinacalcet and placebo in subjects with PHPT unable to undergo parathyroidectomy .", "Phase 3 , double-blind , multi centere , randomized , placebo-controlled study .", "Sixty-seven subjects ( 78 % women ) with moderate PHPT were randomized ( 1:1 ) to cinacalcet or placebo for 28 weeks .", "Achievement of a normal mean corrected total serum calcium concentration of 10.3 mg/dl ( 2.575 mmol/l ) .", "Baseline median ( quartile 1 ( Q1 ) , Q3 ) serum PTH was 164.0 ( 131.0 , 211.0 ) pg/ml and mean ( s.d. ) serum Ca was 11.77 ( 0.46 ) mg/dl .", "Serum Ca normalized ( 10.3 mg/dl ) in 75.8 % of cinacalcet - vs 0 % of placebo-treated subjects ( P < 0.001 ) .", "Corrected serum Ca decreased by 1.0 mg/dl from baseline in 84.8 % of cinacalcet - vs 5.9 % of placebo-treated subjects ( P < 0.001 ) .", "Least squares mean ( s.e.m. ) plasma PTH change from baseline was -23.80 % ( 4.18 % ) ( cinacalcet ) vs -1.01 % ( 4.05 % ) ( placebo ) ( P < 0.001 ) .", "Similar numbers of subjects in the cinacalcet and placebo groups reported adverse events ( AEs ) ( 27 vs 20 ) and serious AEs ( three vs four ) .", "Most commonly reported AEs were nausea and muscle spasms .", "These results demonstrate that cinacalcet normalizes serum calcium in this PHPT population and appears to be well tolerated ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "This randomized phase III trial compared pathologic complete response ( pCR ) rates of early breast cancer ( EBC ) following neoadjuvant epirubicin-docetaxel ( ED ) capecitabine ( C ) , and evaluated the addition of trastuzumab in HER2-positive tumors .", "Patients with invasive breast cancer ( except T4d ) were randomly assigned to receive six 3-weekly cycles of ED ( both 75 mg/m2 ) C ( 1000 mg/m2 , twice daily , days 1-14 ) .", "Patients with HER2-positive disease were further randomized to receive trastuzumab ( 8 mg/kg , then 6 mg/kg every 3 weeks ) or not .", "Primary end point : pCR rate at the time of surgery .", "Five hundred thirty-six patients were randomized to ED ( n = 266 ) or EDC ( n = 270 ) ; 93 patients were further randomized to trastuzumab ( n = 44 ) or not ( n = 49 ) .", "pCR rate was significantly increased with EDC ( 23.0 % versus 15.4 % ED , P = 0.027 ) , and nonsignificantly further increased with trastuzumab ( 38.6 % EDC versus 26.5 % ED , P = 0.212 ) .", "Rates of axillary node involvement at surgery and breast conservation were improved with EDC versus ED , but not significantly ; the addition of trastuzumab had no further impact .", "Hormone receptor status , tumor size , grade , and C ( all P0 .035 ) were independent prognostic factors for pCR .", "Trastuzumab added to EDC significantly increased the number of serious adverse events ( 35 versus 18 ; P = 0.020 ) , mainly due to infusion-related reactions .", "These findings show that the integration of C into a neoadjuvant taxane - / anthracycline-based regimen is a feasible , safe , and effective treatment option , with incorporation of trastuzumab in HER2-positive disease .", "NCT00309556 , www.clinicaltrials.gov ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "This study explored the safety and efficacy of recombinant type I pancreatic elastase ( PRT-201 ) topically applied once to the external surface of an arteriovenous fistula .", "This was a randomized , double-blind , placebo-controlled trial .", "Adults with kidney disease undergoing creation of a radiocephalic fistula ( RCF ) or brachiocephalic fistula were randomized to treatment with placebo ( n = 51 ) , PRT-201 at 10 g ( n = 51 ) , or PRT-201 at 30 g ( n = 49 ) .", "The primary efficacy measure was unassisted primary patency ( PP ) over 1 year .", "Secondary efficacy measures were secondary patency ( SP ) , unassisted maturation by ultrasound interrogation , use for hemodialysis , and hemodynamically significant lumen stenosis .", "Median PP was 224 days for placebo and > 365 days for the PRT-201 groups .", "At 1 year , 45 % , 54 % , and 53 % of placebo , 10-g , and 30-g patients retained PP .", "The risk of PP loss was nonsignificantly reduced for 10 g ( hazard ratio [ HR ] , 0.69 ; P = .19 ) and 30 g ( HR , 0.67 ; P = .17 ) vs placebo .", "In the subset ( 44 % of patients ) with a RCF , the median PP was 125 days for placebo and > 365 days for the PRT-201 groups .", "At 1 year , 31 % , 50 % , and 63 % of placebo , 10-g , and 30-g RCFs retained PP .", "The risk of RCF PP loss was nonsignificantly reduced by 10 g ( HR , 0.59 ; P = .18 ) and significantly reduced by 30 g ( HR , 0.37 ; P = .02 ) vs placebo .", "At 1 year , 77 % , 81 % , and 83 % of placebo , 10-g , and 30-g patients retained SP .", "The risk of SP loss was nonsignificantly reduced for 10 g ( HR , 0.79 ; P = .61 ) and 30 g ( HR , 0.76 ; P = .55 ) vs placebo .", "In the subset with RCFs , 65 % , 82 % , and 90 % of placebo , 10-g , and 30-g patients retained SP at 1 year .", "The risk of RCF SP loss was nonsignificantly reduced for 10 g ( HR , 0.45 ; P = .19 ) and 30 g ( HR , 0.27 ; P = .08 ) vs placebo .", "At month 3 , 67 % , 87 % ( P = .03 ) , and 92 % ( P < .01 ) of the placebo , 10-g , and 30-g group fistulas had unassisted maturation by ultrasound interrogation .", "At month 3 in the subset with an RCF , 47 % , 74 % ( P = .17 ) , and 93 % ( P < .01 ) of placebo , 10-g , and 30-g group fistulas had unassisted maturation by ultrasound interrogation .", "Adverse event reports were not meaningfully different between groups .", "PRT-201 appeared safe .", "The primary efficacy end point was not met .", "However , both PRT-201 doses were associated with improved unassisted maturation .", "The 30-g dose was associated with increased PP in the subset with RCF ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Ingestion of polyunsaturated fatty acids ( PUFAs ) has been proposed to influence several chronic diseases including coronary heart disease ( CHD ) and type-2 diabetes ( T2D ) .", "There is strong evidence that omega-3 ( n-3 ) PUFAs provide protection against CHD and biomarkers of atherosclerosis .", "In contrast , there is more limited and inconsistent data for T2D .", "Few studies have examined the impact of n-3 PUFA-containing botanical oils on T2D .", "Fifty-nine subjects with early-stageT2D or metabolic syndrome participated in an 8-week , randomized , single-blind , parallel intervention study and were provided PUFA-containing oils .", "Individuals received either corn oil ( CO ) , a botanical oil ( BO ) combination ( borage [ Borago officinalis L. ] / echium oil [ Echium plantagineum L. ] ) or fish oil ( FO ) .", "The BO combination was enriched in alpha-linolenic , gamma-linolenic , and stearidonic acids and the FO in eicosapentaenoic and docosahexaenoic acids .", "Serum fatty acids and other serum lipids ( triglycerides and total , HDL and LDL cholesterol ) , as well as markers of inflammation ( leptin , and C-reactive protein ) and glucose regulation ( glucose and hemoglobin A1c ) were assessed from fasting participants at baseline and after the intervention .", "Compliance was verified by expected increases in specific PUFAs in each of the three oil arms .", "Participants in the CO group showed no differences in serum lipids , markers of inflammation or glucose regulation between pre - and post-treatment measures .", "Supplementation with BO significantly lowered total and LDL cholesterol levels and FO reduced serum triglycerides , hemoglobin A1c and increased HDL-cholesterol .", "Short-term dietary supplementation with BO and FO improved biomarkers associated with T2D/metabolic syndrome .", "Clinicaltrial.gov NCT01145066 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "BACKGROUND" ]

[ "The role of secondary cytoreductive surgery ( SCR ) in platinum-sensitive recurrent ovarian cancer ( ROC ) remains controversial .", "The overall survival ( OS ) benefits for surgery reported in observational studies may be due to the selection of patients with better prognosis .", "Using data from the CALYPSO trial , OS of patients who had SCR was compared to those treated with chemotherapy alone .", "Multivariate analyses were performed to adjust for prognostic factors .", "We also tested for an interaction between baseline prognostic groupings and the benefit of surgery .", "Of the 975 patients randomised in CALYPSO , 19 % had SCR and 80 % had chemotherapy alone .", "OS was longer for the SCR group than for chemotherapy alone ( median , 49.9 vs. 29.7 months ; adjusted hazard ratio ( HR ) , 0.68 ; P = 0.004 ) .", "For patients with SCR , the 3-year OS was 72 % for those with no measurable disease , and 28 % if residual tumour was larger than 5 cm .", "Patients with good prognostic features benefited the most from SCR ( HR 0.43 ; P < 0.001 ) .", "The benefit of SCR was less in patients with poorer prognostic features ( test of trend P < 0.001 ) .", "SCR was associated with improved OS in platinum-sensitive ROC , particularly in patients with favourable prognostic characteristics .", "However , these findings may be due to selection bias , and hence randomised trials are still essential ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To evaluate the verbal and written preoperative information in patients undergoing surgery for malignant gynaecologic disease , in terms of satisfaction about preoperative received informations , hospitalization days , postoperative pain experienced using visual analogue scale ( VAS ) and number of pain drugs used daily .", "From January 2008 to December 2012 , consecutive patients with diagnosis of endometrial cancer , referred to the Division of Gynecology of University Campus Bio-Medico of Rome , were enrolled .", "Eligible subjects were randomized into two groups : Group V ( Verbal information ward ) consisted of patients who had verbal preoperative information about surgical procedure and postoperative management and Group W ( Written Information ward ) consisted of patients who had written preoperative information .", "All preoperative and postoperative data were recorded .", "Concerning satisfaction about preoperative received informations , patients were asked to complete the QLQ-C30 and the EORTC INFO25 .", "190 patients were considered in this study .", "Group W ( n = 92 ) has a better info satisfaction ( p = 0.0008 , statistically significant ) , a mean VAS value lower ( p = 0.02 , statistically significant ) and also a lower number of hospitalization days ( p = 0.0265 , statistically significant ) and pain medications used daily , ( p = 0.0120 , statistically significant ) , comparing with group V ( n = 98 ) .", "We support the use of preoperative information leaflet to better prepare patients for a surgical procedure , showing a faster recovery , low medications use and a better quality of life outcome ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "In most Asian countries , 50 - 90 % of pharmaceutical sales are made in private drug outlets , by personnel with some training in drugs but not for the treatment of common health problems .", "The objective of the study was to determine effects of focused training for private drug sellers to improve practices in treating acute respiratory infections and diarrhoea in children , and anaemia in pregnancy in Nepal .", "Randomized controlled , four way nested design study incorporating four interventions for drug retailers in both hill and terai districts .", "One group received mailed printed educational materials followed by mailed feedback ; a second received small group training followed by feedback ; a third received small group training only ; and a fourth , the control group , received no intervention .", "Surrogate customer method was used to assess practices .", "Outcomes were measured using multivariate linear regression .", "A significant increase in the asking of key history questions , recommendation ( prescribing by drug retailers ) of cotrimoxazole , and advice-giving for pneumonia ; a significant increase in ORS recommendation , and advice giving for diarrhoea including the avoidance of antidiarrhoeals ; and a significant increase in asking key history questions and recommending appropriate products in pregnancy cases .", "Training intervention as well as training followed by practice feedback was effective in improving the management of common illnesses and pregnancy by private drug sellers ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]

[ "A post hoc analysis to determine the diagnostic yield of random biopsy in detecting high-grade cervical disease in women with negative colposcopy .", "The ATHENA ( Addressing the Need for Advanced HPV Diagnostics ) trial screened more than 47,000 women with cytology and high-risk human papillomavirus ( HPV ) DNA genotyping .", "Colposcopy was performed in all women with abnormal cytology or positive HPV results .", "A single random biopsy was taken at the squamocolumnar junction if colposcopy was adequate and no lesions were identified .", "The random biopsy diagnosed 20.9 % ( 81/388 , 95 % confidence interval [ CI ] 16.9-25 .3 % ) and 18.9 % ( 45/238 , 95 % CI 14.1-24 .5 % ) of the total cervical intraepithelial neoplasia ( CIN ) grade 2 or worse and grade 3 or worse , respectively .", "This additional disease was detected in both HPV 16 or 18 + and for 12 other high-risk HPV + women .", "For HPV 16 or 18 , the absolute risk for detection of CIN 2 or worse on random biopsy in the overall population was 13.1 % ( 40/305 , 95 % CI 9.8-17 .4 % ) and 8.2 % ( 25/305 , 95 % CI 5.6-11 .8 % ) for CIN 3 or worse .", "By contrast , the absolute risk for 12 other high-risk HPV + women was 3.5 % ( 29/820 , 95 % CI 2.5-5 % ) and 1.7 % ( 14/820 , 95 % CI 1.0-2 .8 % ) for CIN 2 or worse and CIN 3 or worse , respectively .", "A single random biopsy increased the detection of high-grade disease when no lesions were visualized at colposcopy .", "The absolute risks of disease associated with the random biopsy were highest for women positive for genotype 16 or 18 .", "Our study supports performing a random biopsy in women undergoing colposcopy without visible lesions , particularly in those positive for HPV 16 or 18 .", ": II ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "METHODS" ]

[ "Pain and potential adverse events ( AE ) remain challenges for patients being treated with calcium hydroxylapatite ( CaHA ; Radiesse ) , especially CaHA not mixed with an anesthetic .", "The blunt cannula may provide more comfortable and lower risk delivery of CaHA for nasolabial folds ( NLF ) correction .", "This 30-day pilot study was designed to compare the effectiveness and safety of standard needles with that of blunt cannulas for CaHA application .", "Twenty patients with moderate to severe NLF received split-face injections of CaHA mixed with 2 % lidocaine using a cannula for one NLF and needle for the other NLF .", "At day 0 , patients evaluated pain ; the treating investigator evaluated changes in NLF depth .", "At 0 , 3 , 7 , 14 , and 30days , the investigator evaluated AEs and NLF correction .", "Patients recorded AEs in daily dairies .", "After initial treatment , patients experienced greater pain and displayed increased erythema and swelling in the needle-treated side .", "At days 3 and 7 , patients displayed greater instances of bruising , redness , and swelling in the needle-treated sides .", "At day 30 , 19 patients showed slightly better correction in the cannula-treated sides .", "The blunt cannula provided advantages in mitigation of pain and AEs , with a degree of correction similar to needle .", "The addition of blunt cannulas to the clinical setting may be appropriate ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The aim of the study was to investigate the effects of the early initiation of passive and active range of motion exercises following arthroscopic rotator cuff repair .", "The study included 40 patients who underwent arthroscopic rotator cuff repair .", "Patients were quasi-randomly assigned into accelerated ( ACCEL ) protocol ( n = 19 ) and slow ( SLOW ) protocol ( n = 21 ) groups .", "Patients in both groups were treated with the same protocol .", "Active range of motion was begun at the 3rd week in the ACCEL group and the 6th week in the SLOW group .", "Range of motion was recorded at postoperative weeks 3 , 5 , 8 , 12 , and 24 .", "While active range of motion for all measurements improved across weeks , there were no differences between groups , with the exception of active total elevation which was greater at all time point measurements in the ACCEL group ( p < 0.05 ) .", "The early initiation of passive and gentle controlled active motion exercise following rotator cuff repairs does not appear to affect range of motion in the first 6 postoperative months ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS" ]

[ "The safety of the manual treatment techniques such as spinal manipulation has been discussed and there is a need for more information about potential adverse events after manual therapy .", "The aim of this randomized controlled trial was to investigate differences in occurrence of adverse events between three different combinations of manual treatment techniques used by manual therapists ( i.e. chiropractors , naprapaths , osteopaths , physicians and physiotherapists ) for patients seeking care for back and/or neck pain .", "In addition women and men were compared regarding the occurrence of adverse events .", "Participants were recruited among patients , ages 18-65 , seeking care at the educational clinic of the Scandinavian College of Naprapathic Manual Medicine in Stockholm .", "The patients ( n = 767 ) were randomized to one of three treatment arms 1 ) manual therapy ( i.e. spinal manipulation , spinal mobilization , stretching and massage ) ( n = 249 ) , 2 ) manual therapy excluding spinal manipulation ( n = 258 ) and 3 ) manual therapy excluding stretching ( n = 260 ) .", "Treatments were provided by students in the seventh semester of total eight .", "Adverse events were measured with a questionnaire after each return visit and categorized in to five levels ; 1 ) short minor , 2 ) long minor , 3 ) short moderate , 4 ) long moderate and 5 ) serious adverse events , based on the duration and/or severity of the event .", "Generalized estimating equations were used to examine the association between adverse event and treatments arms .", "The most common adverse events were soreness in muscles , increased pain and stiffness .", "No differences were found between the treatment arms concerning the occurrence of adverse event .", "Fifty-one percent of patients , who received at least three treatments , experienced at least one adverse event after one or more visits .", "Women more often had short moderate adverse events ( OR = 2.19 ( 95 % CI : 1.52-3 .15 ) ) , and long moderate adverse events ( OR = 2.49 ( 95 % CI : 1.77-3 .52 ) ) compared to men .", "Adverse events after manual therapy are common and transient .", "Excluding spinal manipulation or stretching do not affect the occurrence of adverse events .", "The most common adverse event is soreness in the muscles .", "Women reports more adverse events than men .", "This trial was registered in a public registry ( Current Controlled Trials ) ( ISRCTN92249294 ) ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "Surgical resection is the only curative treatment for gastric cancer .", "However , the overall prognosis of gastric adenocarcinoma is poor and advanced disease may even make surgical treatment impossible .", "It has been theoretically proposed that administration of chemotherapy before surgical resection may down-stage the disease state and facilitate resectability especially in locally-advanced tumors .", "We wanted to assess the effect of administration of neoadjuvant chemotherapy on tumor resectability in patients with locally-advances gastric adenocarcinoma .", "During a randomized-controlled trial , we divided 60 patients with locally-advanced gastric adenocarcinoma into two groups of neoadjuvant chemotherapy and surgery ( case ) versus surgery alone ( control ) .", "Because of patient dropouts , we analyzed the results for 22 and 29 patients in case and control groups respectively .", "The study period was March 21 , 2011 to March 20 , 2014 .", "A non-randomized set of 23 patients were also added to the control group ( Multi-center analysis ) .", "The analysis was repeated for non-randomized patients ( 22 case patients versus 52 control patients ) .", "The mean age of patients in case and control groups was 58.39.1 and 59.78.7 years of age respectively ( p > 0.05 ) .", "Male to female ratio was 15/7 and 41/11 in case and control groups respectively ( p > 0.05 ) .", "In Randomized patients , 19 patients ( 86.4 % ) were resectable in case group ; while 16 patients ( 55.2 % ) were resectable in control group ( p < 0.05 ) .", "Multicenter analysis also revealed resectability in 19 patients ( 86.4 % ) and 31 patients ( 59.6 % ) of case and control groups respectively ( p < 0.05 ) .", "We conclude that neoadjuvant chemotherapy could increase tumor resectability rate in patients with locally-advanced gastric adenocarcinoma .", "However , further studies are necessary to confirm the effect of this modality on patients ' overall survival ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "This study was designed to evaluate and compare the efficacy and safety of nebulized dexmedetomidine , nebulized ketamine , and the combination of these drugs for premedication in pediatric outpatient dental surgeries .", "A prospective , randomized , double-blinded study was conducted in the Alexandria Main University Hospital after approval of the Medical Ethics Committee .", "Informed written consent was obtained from the patient 's parents .", "Sixty children classified as ASA physical status I and II and aged 3 to 6 years were enrolled in the study .", "Patients were randomly categorized into 3 equal groups .", "Group K was premedicated with nebulized ketamine ( 2 mg/kg ) , group D was premedicated with nebulized dexmedetomidine ( 2 g/kg ) , and group DK was premedicated with combined nebulized dexmedetomidine and ketamine ( 1 g/kg + 1 mg/kg ) .", "The primary end point was the level of sedation when the child was first seen in the operating room 30 minutes after sedation .", "The secondary end points were tolerance of mask induction , hemodynamic changes , analgesia , sedation at emergence , and wake-up behavior .", "Studied groups were comparable as regards demographic data ( age , weight , sex , and ASA physical status , all P > 0.226 ) and patients ' acceptance of drugs ( P = 0.968 ) .", "Level of sedation at 30 minutes was significantly greater in group DK than in either group K ( P = 0.003 ) or group D ( P = 0.009 ) .", "Group DK had the briefest recovery times , followed in order by group K and group D with progressively longer recovery times .", "Recovery times were significantly briefer in group DK than in either group K ( P = 0.039 ) or group D ( P < 0.001 ) .", "Group DK had significantly briefer discharge times than group D ( P < 0.001 ) .", "Postoperative analgesia was significantly better in group DK compared with group K ( P = 0.008 ) .", "A nebulized combination of low-dose ketamine and dexmedetomidine produced more satisfactory sedation and provided a smoother induction of general anesthesia than nebulized ketamine or dexmedetomidine alone , with more rapid recovery and no significant side effects ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Maternal nutritional status is an important predictor of infant birthweight .", "Most previous attempts to improve birthweight through multiple micronutrient supplementation have been initiated after women are pregnant .", "Interventions to improve maternal nutritional status prior to conception may be more effective in preventing low birthweight and improving other infant health outcomes .", "To compare the effects of maternal supplementation with animal-source food from preconception to term or from mid-gestation to term with routine prenatal care on birthweight , the prevalence of preterm births , intrauterine growth restriction , and infant growth during the first 12 months of life and on maternal nutrient status and the incidence of maternal and infant infections .", "Young women from 29 rural communes in northwestern Vietnam were recruited when they registered to marry and were randomized to one of three interventions : animal-source food supplement 5 days per week from marriage to term ( approximately 13 months ) , animal-source food supplement 5 days per week from 16 weeks of gestation to term ( approximately 5 months ) , or routine prenatal care without supplementalfeeding .", "Data on infant birthweight and gestational age , maternal and infant anthropometry , micronutrient status , and infections in the infant and mother were collected at various time points .", "In a preliminary study of women of reproductive age in this area of Vietnam , 40 % of the women were underweight ( body mass index < 18.5 ) and anemic .", "About 50 % had infections .", "Rice was the dietary staple , and nutrient-rich , animal-source foods were rarely consumed by women .", "Iron , zinc , vitamin A , folate , and vitamin B12 intakes were inadequate in about 40 % of the women .", "The study is still ongoing , and further data are not yet available .", "The results of this study will provide important data regarding whether improved intake of micronutrient-rich animal-source foods that are locally available and affordable before and during pregnancy improves maternal and infant health and development .", "This food-based approach may have global implications regarding how and when to initiate sustainable nutritional interventions to improve maternal and infant health ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Suvorexant , an orexin receptor antagonist , improves sleep in healthy subjects ( HS ) and patients with insomnia .", "We compared the electroencephalographic ( EEG ) power spectral density ( PSD ) profile of suvorexant with placebo using data from a phase 2 trial in patients with insomnia .", "We also compared suvorexant 's PSD profile with the profiles of other insomnia treatments using data from 3 HS studies .", "Phase 2 trial -- randomized , double-blind , two-period ( 4 w per period ) crossover .", "HS studies -- randomized , double-blind , crossover .", "Sleep laboratories .", "Insomnia patients ( n = 229 ) or HS ( n = 124 ) .", "Phase 2 trial -- suvorexant 10 mg , 20 mg , 40 mg , 80 mg , placebo ; HS study 1 -- suvorexant 10 mg , 50 mg , placebo ; HS study 2 -- gaboxadol 15 mg , zolpidem 10 mg , placebo ; HS study 3 -- trazodone 150 mg , placebo .", "The PSD of the EEG signal at 1-32 Hz of each PSG recording during nonrapid eye movement ( NREM ) and rapid eye movement ( REM ) sleep were calculated .", "The day 1 and day 28 PSD profiles of suvorexant at all four doses during NREM and REM sleep in patients with insomnia were generally flat and close to 1.0 ( placebo ) at all frequencies .", "The day 1 PSD profile of suvorexant in HS was similar to that in insomnia patients .", "In contrast , the other three drugs had distinct PSD profiles in HS that differed from each other .", "Suvorexant at clinically effective doses had limited effects on power spectral density compared with placebo in healthy subjects and in patients with insomnia , in contrast to the three comparison insomnia treatments .", "These findings suggest the possibility that antagonism of the orexin pathway might lead to improvements in sleep without major changes in the patient 's neurophysiology as assessed by electroencephalographic ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Novel interventions tailored to blue collar workers are needed to reduce the disparities in smoking rates among occupational groups .", "The main objective of this study was to evaluate the efficacy and usage of the Web-enhanced `` Tobacco Tactics '' intervention targeting operating engineers ( heavy equipment operators ) compared to the `` 1-800-QUIT-NOW '' telephone line .", "Operating engineers ( N = 145 ) attending one of 25 safety training sessions from 2010 through 2012 were randomized to either the Tobacco Tactics website with nurse counseling by phone and access to nicotine replacement therapy ( NRT ) or to the 1-800-QUIT-NOW telephone line , which provided an equal number of phone calls and NRT .", "The primary outcome was self-reported 7-day abstinence at 30-day and 6-month follow-up .", "The outcomes were compared using chi-square tests , t tests , generalized mixed models , and logistic regression models .", "The average age was 42 years and most were male ( 115/145 , 79.3 % ) and white ( 125/145 , 86.2 % ) .", "Using an intent-to-treat analysis , the Tobacco Tactics website group showed significantly higher quit rates ( 18/67 , 27 % ) than the 1-800-QUIT NOW group ( 6/78 , 8 % ) at 30-day follow-up ( P = .003 ) , but this difference was no longer significant at 6-month follow-up .", "There were significantly more positive changes in harm reduction measures ( quit attempts , number of cigarettes smoked per day , and nicotine dependence ) at both 30-day and 6-month follow-up in the Tobacco Tactics group compared to the 1-800-QUIT-NOW group .", "Compared to participants in the 1-800-QUIT NOW group , significantly more of those in the Tobacco Tactics website group participated in the interventions , received phone calls and NRT , and found the intervention helpful .", "The Web-enhanced Tobacco Tactics website with telephone support showed higher efficacy and reach than the 1-800-QUIT-NOW intervention .", "Longer counseling sessions may be needed to improve 6-month cessation rates .", "Clinicaltrials.gov NCT01124110 ; http://clinicaltrials.gov/ct2/show/NCT01124110 ( Archived by WebCite at http://www.webcitation.org/6TfKN5iNL ) ." ]

[ "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The National Lung Screening Trial ( NLST ) showed that screening with low-dose computed tomography ( CT ) as compared with chest radiography reduced lung-cancer mortality .", "We examined the cost-effectiveness of screening with low-dose CT in the NLST .", "We estimated mean life-years , quality-adjusted life-years ( QALYs ) , costs per person , and incremental cost-effectiveness ratios ( ICERs ) for three alternative strategies : screening with low-dose CT , screening with radiography , and no screening .", "Estimations of life-years were based on the number of observed deaths that occurred during the trial and the projected survival of persons who were alive at the end of the trial .", "Quality adjustments were derived from a subgroup of participants who were selected to complete quality-of-life surveys .", "Costs were based on utilization rates and Medicare reimbursements .", "We also performed analyses of subgroups defined according to age , sex , smoking history , and risk of lung cancer and performed sensitivity analyses based on several assumptions .", "As compared with no screening , screening with low-dose CT cost an additional $ 1,631 per person ( 95 % confidence interval [ CI ] , 1,557 to 1,709 ) and provided an additional 0.0316 life-years per person ( 95 % CI , 0.0154 to 0.0478 ) and 0.0201 QALYs per person ( 95 % CI , 0.0088 to 0.0314 ) .", "The corresponding ICERs were $ 52,000 per life-year gained ( 95 % CI , 34,000 to 106,000 ) and $ 81,000 per QALY gained ( 95 % CI , 52,000 to 186,000 ) .", "However , the ICERs varied widely in subgroup and sensitivity analyses .", "We estimated that screening for lung cancer with low-dose CT would cost $ 81,000 per QALY gained , but we also determined that modest changes in our assumptions would greatly alter this figure .", "The determination of whether screening outside the trial will be cost-effective will depend on how screening is implemented .", "( Funded by the National Cancer Institute ; NLST ClinicalTrials.gov number , NCT00047385 . )" ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "We evaluated the use of tamsulosine versus placebo for management of ureteral stent discomfort .", "This prospective and randomized study was realized in the Department of Urology of three university hospital .", "The participation was proposed at all patient having indication to receive an ureteral stent except for cancer .", "The evaluation of the tolerance used two validate questionnaires : Ureteral Stent Symptom Questionnaire ( USSQ ) and IPSS completed by each patient the day of the insertion , next day , one week later and the day before and after the removal .", "The main assessment criterion was the question `` global quality of life '' one week after the stent insertion .", "Seventy-nine patients were randomized between June , 2010 and October , 2012 .", "Despite phone reminders only 38 ( 48.1 % ) were complete questionnaires .", "Out of 39 , 18 patients in the tamsulosine group and out of 40 , 20 in the phloroglucinol group .", "The majority of the patients ( 92 % ) were included for stone disease .", "There is not significant difference between the 2 groups using the USSQ and IPSS at day +1 , day +7 , pre-ablation and day +1 ablation .", "A significant improvement of the scores was noted to day +1 by the ablation of the JJ in 2 groups .", "Our study did not show superiority of tamsulosine versus placebo in the improvement of the tolerance of ureteral stent .", "2 ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "METHODS" ]

[ "Permissive hypercapnia is a ventilatory strategy used to prevent lung injury in ventilated extremely low birth weight ( ELBW , birth weight 1,000 g ) infants .", "However , there is retrospective evidence showing that high CO2 is associated with brain injury .", "The objective of this study was to compare brain white matter development at term-equivalent age in ELBW infants randomized to hypercapnic vs. normocapnic ventilation during the first week of life and in healthy non-ventilated term newborns .", "Twenty-two ELBW infants from a randomized controlled trial were included in this study ; 11 received hypercapnic ( transcutaneous PCO2 [ tcPCO2 ] 50-60 mmHg ) ventilation and 11 normocapnic ( tcPCO2 35-45 mmHg ) ventilation during the first week of life while still intubated .", "In addition , ten term healthy newborns served as controls .", "Magnetic resonance imaging ( MRI ) with diffusion tensor imaging ( DTI ) was performed at term-equivalent age for the ELBW infants and at approximately 2 weeks of age for the control infants .", "White matter injury on conventional MRI was graded in the ELBW and control infants using a scoring system adopted from literature .", "Tract-based spatial statistics ( TBSS ) was used to evaluate for differences in DTI measured fractional anisotropy ( FA , spatially normalized to a customized template ) among the ELBW and term control infants .", "Conventional MRI white matter scores were not different ( 7.31.7 vs. 6.91.4 , P = 0.65 ) between the hypercapnic and normocapnic ELBW infants .", "TBSS analysis did not show significant differences ( P < 0.05 , corrected ) between the two ELBW infant groups , although before multiple comparisons correction , hypercapnic infants had many regions with lower FA and no regions with higher FA ( P < 0.05 , uncorrected ) compared to normocapnic infants .", "When compared to the control infants , normocapnic ELBW infants had a few small regions with significantly lower FA , while hypercapnic ELBW infants had more widespread regions with significantly lower FA ( P < 0.05 , fully corrected for multiple comparisons ) .", "Normocapnic ventilation vs. permissive hypercapnia may be associated with improved white matter development at term-equivalent age in ELBW infants .", "This effect , however , was small and was not apparent on conventional MRI .", "Further research is needed using larger sample sizes to assess if permissive hypercapnic ventilation in ELBW infants is associated with worse white matter development ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Antidepressants are effective in adults with pain-related functional gastrointestinal disorders .", "We investigated the effectiveness of citalopram in the treatment of childhood functional abdominal pain ( FAP ) .", "Children with FAP , based on the Rome III criteria ( n = 115 , aged 6-18 years ) , were randomized to receive either citalopram 20 mg/day or placebo for 4 weeks .", "Treatment response was defined as 2 point reduction in the 6-point Faces pain rating scale or ` no pain ' .", "Depression , anxiety , somatization , and physician-rated global severity and improvement were also evaluated .", "Patients were followed up for 8 weeks after medication period .", "Eighty-six patients completed the medication ( 43 in each group ) .", "Response rate in the citalopram and placebo groups based on per-protocol ( intention-to-treat ) analysis was 55.8 % ( 40.6 % ) and 39.5 % ( 30.3 % ) at week 4 ( p = 0.097 [ 0.169 ] ) and 72.0 % ( 52.5 % ) and 53.4 % ( 41.0 % ) at week 12 ( p = 0.059 [ 0.148 ] ) , respectively .", "In per-protocol analysis , more reduction was observed in pain ( F = 3.84 , p = 0.024 ) and global severity scores ( F = 4.12 , p = 0.021 ) in the citalopram group compared with the placebo group over the study period .", "Such differences were not present in the intention-to-treat analysis .", "No difference was found between the two groups regarding change in depression , anxiety , or somatization score over the study .", "Overall , we found a trend toward the effectiveness of citalopram in the treatment of children with FAP .", "Trials with longer treatment duration in larger samples of patients are required in this regard ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Noninvasive continuous positive airway pressure ( CPAP ) is usually applied with a nasal or facial mask to treat mild acute respiratory failure ( ARF ) in infants .", "A pediatric helmet has now been introduced in clinical practice to deliver CPAP .", "This study compared treatment failure rates during CPAP delivered by helmet or facial mask in infants with respiratory syncytial virus-induced ARF .", "In this multicenter randomized controlled trial , 30 infants with respiratory syncytial virus-induced ARF were randomized to receive CPAP by helmet ( n = 17 ) or facial mask ( n = 13 ) .", "The primary endpoint was treatment failure rate ( defined as due to intolerance or need for intubation ) .", "Secondary outcomes were CPAP application time , number of patients requiring sedation , and complications with each interface .", "Compared with the facial mask , CPAP by helmet had a lower treatment failure rate due to intolerance ( 3/17 [ 17 % ] vs 7/13 [ 54 % ] , P = .009 ) , and fewer infants required sedation ( 6/17 [ 35 % ] vs 13/13 [ 100 % ] , P = .023 ) ; the intubation rates were similar .", "In successfully treated patients , CPAP resulted in better gas exchange and breathing pattern with both interfaces .", "No major complications due to the interfaces occurred , but CPAP by mask had higher rates of cutaneous sores and leaks .", "These findings confirm that CPAP delivered by helmet is better tolerated than CPAP delivered by facial mask and requires less sedation .", "In addition , it is safe to use and free from adverse events , even in a prolonged clinical setting ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "TG4040 is a modified vaccinia Ankara ( MVA ) virus that expresses the hepatitis C virus ( HCV ) proteins NS3 , NS4 , and NS5B .", "We performed a phase II open-label study to determine the efficacy , safety , and immunotherapeutic properties of TG4040 in combination with pegylated interferon -2 a and ribavirin ( PEG-IFN/RBV ) in patients with chronic HCV infection .", "Treatment-naive patients with HCV genotype 1 infection were assigned randomly to 1 of thefollowing groups : PEG-IFN/RBV for 48 weeks ( group A , n = 31 ) , PEG-IFN/RBV for 4 weeks followed by PEG-IFN/RBV for 44 weeks with 6 injections of TG4040 ( group B , n = 63 ) , or TG4040 for 12 weeks ( 7 injections ) followed by PEG-IFN/RBV for 48 weeks with 6 injections of TG4040 ( group C , n = 59 ) .", "The primary end point was complete early virologic response ( cEVR ) , defined as HCV-RNA level less than10 IU/mL after 12 weeks of PEG-IFN/RBV treatment .", "In group C , 64.2 % of evaluable patients achieved cEVR , compared with 30.0 % in group A and 45.9 % in group B ( P = .0003 for group C vs A ) .", "A higher percentage of patients achieved a sustained virologic response 24 weeks after therapy ended in group C ( 58.2 % ) than in groups A ( 48.4 % ) or B ( 50.8 % ) .", "HCV - and MVA-specific T-cell responses were observed predominantly in group C.", "As expected , most patients given injections of TG4040 developed anti-MVA antibodies .", "The combination of TG4040 and PEG-IFN/RBV was reasonably well tolerated .", "However , PEG-IFN-associated thrombocytopenia developed in 3 patients who carried the class II HLA allele DRB01 * 04 .", "A higher percentage of patients with chronic HCV infection who received immunotherapy with TG4040 followed by TG4040 and PEG-IFN/RBV achieved a cEVR compared with patients who received only PEG-IFN/RBV therapy .", "These findings show that immunotherapies that activate T cells are effective in patients with chronic HCV infection .", "ClinicalTrials.gov number , NCT01055821 ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "We aimed to identify doses of mirogabalin ( DS-5565 ) providing clinically meaningful efficacy with manageable side effects for treatment of diabetic peripheral neuropathic pain ( DPNP ) .", "Adults ( 18 years ) with type 1 or 2 diabetes , HbAc 10 % at screening , and DPNP for 6 months were eligible for study participation .", "Subjects ( n = 452 ) were randomized ( 2:1:1:1:1:1:1 ratio ) to placebo , dose-ranging mirogabalin ( 5 , 10 , 15 , 20 , and 30 mg/day ) , or pregabalin ( 300 mg/day ) for 5 weeks .", "The primary end point was weekly change in average daily pain score ( ADPS ; 0 to 10 numeric rating scale ) from baseline to week 5 ( minimally meaningful effect , 1.0-point decrease versus placebo ) .", "ANCOVA was conducted using last observation carried forward , and treatment effect least squares ( LS ) means were provided for each contrast .", "Safety assessments included adverse events ( AEs ) , clinical laboratory tests , and electrocardiograms .", "LS mean differences in change in ADPS from baseline to week 5 versus placebo were -0.22 , -0.53 , -0.94 , -0.88 , and -1.01 for the mirogabalin 5 - , 10 - , 15 - , 20 - , and 30-mg/day treatment groups , respectively , and -0.05 in the pregabalin group ( P < 0.05 versus placebo for mirogabalin 15 , 20 , and 30 mg/day ) .", "Most frequent AEs ( n = 277 ) were primarily mild to moderate dizziness ( 9.4 % ) , somnolence ( 6.1 % ) , and headache ( 6.1 % ) ; otherwise , mirogabalin was well tolerated .", "Mirogabalin 15 , 20 , and 30 mg/day had statistically significant reductions in ADPS versus placebo , and mirogabalin 30 mg/day also met the criteria of minimally meaningful effect .", "Mirogabalin may be a promising new treatment option for patients with DPNP ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Flexible fiber-optic bronchoscope-guided orotracheal intubation is a valuable technique with demonstrated benefits in the management of difficult airways .", "Despite its popularity with anesthesia providers , the technique is not fail-safe and airway-related complications secondary to failed intubation attempts remain an important problem .", "We sought to determine the effect of incorporating lingual traction on the success rate of fiber-optic bronchoscope-guided intubation in patients with anticipated difficult airways .", "In this prospective , randomized , cohort study , we enrolled 91 adult patients with anticipated difficult airways scheduled for elective surgery to undergo fiber-optic bronchoscope-guided orotracheal intubation alone or with lingual traction by an individual anesthesiologist after induction of general anesthesia and neuromuscular blockade .", "A total of 78 patients were randomized : 39 patients to the fiber-optic bronchoscope-guided intubation with lingual traction group and 39 patients to the fiber-optic bronchoscope-guided intubation alone group .", "The primary endpoint was the rate of successful first attempt intubations .", "The secondary outcome was sore throat grade on post-operative day 1 .", "Fiber-optic intubation with lingual traction compared to fiber-optic intubation alone resulted in a higher success rate ( 92.3 vs. 74.4 % , ( 2 ) = 4.523 , p = 0.033 ) and greater odds for successful first attempt intubation ( OR 4.138 , 95 % CI 1.041-16 .444 , p = 0.044 ) .", "Sore throat severity on post-operative day 1 was not significantly different but trended towards worsening grades with lingual traction .", "In this study , lingual traction was shown to be a valuable maneuver for facilitating fiber-optic bronchoscope-guided intubation in the management of patients with anticipated difficult airways ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Levels of physical activity ( PA ) in UK children are much lower than recommended and novel approaches to its promotion are needed .", "The Children , Parents and Pets Exercising Together ( CPET ) study is the first exploratory randomised controlled trial ( RCT ) to develop and evaluate an intervention aimed at dog-based PA promotion in families .", "CPET aimed to assess the feasibility , acceptability and potential efficacy of a theory-driven , family-based , dog walking intervention for 9-11 year olds .", "Twenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group .", "Families in the intervention group were motivated and supported to increase the frequency , intensity and duration of dog walking using a number of behaviour change techniques .", "Parents in the intervention group were asked to complete a short study exit questionnaire .", "In addition , focus groups with parents and children in the intervention group , and with key stakeholders were undertaken .", "The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute ( cpm ) .", "Intervention and control groups were compared using analysis of covariance .", "Analysis was performed on an intention to treat basis .", "Twenty five families were retained at follow up ( 89 % ) and 97 % of all outcome data were collected at baseline and follow up .", "Thirteen of 14 ( 93 % ) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable .", "There was a mean difference in child total volume of PA of 27 cpm ( 95 % CI -70 , 123 ) and -3 cpm ( 95 % CI -60 , 54 ) for intervention and control group children , respectively .", "This was not statistically significant .", "Approximately 21 % of dog walking time for parents and 39 % of dog walking time for children was moderate-vigorous PA. .", "The acceptability of the CPET intervention and outcome measures was high .", "Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable , but did not result in a significant increase in child PA in this exploratory trial .", "ISRCTN85939423 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The aim of this study was to assess the prognostic performance of C-terminal provasopressin ( copeptin ) , midregional pro-adrenomedullin ( MR-proADM ) , and midregional pro-atrial natriuretic peptide ( MR-proANP ) in a large prospective cohort of patients with non-ST-segment elevation acute coronary syndrome ( NSTE-ACS ) .", "Copeptin , MR-proADM , and MR-proANP are emerging biomarkers of hemodynamic stress that have been associated with adverse cardiovascular ( CV ) outcomes in heart failure ( HF ) and stable ischemic disease .", "We measured copeptin , MR-proADM , and MR-proANP concentrations in 4,432 patients with NSTE-ACS who were randomized to treatment with ranolazine or placebo in the MERLIN-TIMI 36 ( Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST-Elevation Acute Coronary Syndromes-Thrombolysis In Myocardial Infarction 36 ) trial and followed up for 1 year .", "A high concentration ( quartile 4 vs. quartiles 1 to 3 ) of each biomarker identified an increased risk of CV death or HF ( copeptin : 13.2 % vs. 5.0 % , p < 0.001 ; MR-proADM : 15.8 % vs. 4.1 % , p < 0.001 ; MR-proANP : 17.7 % vs. 3.5 % , p < 0.001 ) as well as CV death , HF , and myocardial infarction individually ( all p 0.001 ) .", "After adjustment for important covariates , each biomarker remained associated with CV death or HF at 1 year ( adjusted hazard ratio : copeptin , 1.71 ; MR-proADM , 1.96 ; MR-proANP , 2.20 ; all p 0.001 ) .", "These biomarkers improved prognostic discrimination and patient re-classification for CV death or HF at 1 year ( all categorical NRI > 10 % , p < 0.001 ) , and maintained independent association with composite CV death or HF when concurrently assessed in a model with clinical indicators plus BNP , cTnI , ST2 , PAPP-A , and MPO ( each p0 .01 ) [ corrected ] .", "Copeptin , MR-proADM , and MR-proANP are complementary prognostic markers for CV death and HF in patients with NSTE-ACS that perform as well as or better than established and other emerging biomarkers and warrant further investigation of application for therapeutic decision making .", "( Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes ; NCT00099788 ) ." ]

[ "OBJECTIVE", "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Glutamine rate of appearance ( Ra ) may be used as an estimate of endogenous glutamine production .", "Recently a technique employing a bolus injection of isotopically labeled glutamine was introduced , with the potential to allow for multiple assessments of the glutamine Ra over time in critically ill patients , who may not be as metabolically stable as healthy individuals .", "Here the technique was used to evaluate the endogenous glutamine production in critically ill patients in the fed state with and without exogenous glutamine supplementation intravenously .", "Mechanically ventilated patients ( n = 11 ) in the intensive care unit ( ICU ) were studied on two consecutive days during continuous parenteral feeding .", "To allow the patients to be used as their own controls , they were randomized for the reference measurement during basal feeding without supplementation , before or after the supplementation period .", "Glutamine Ra was determined by a bolus injection of 13C-glutamine followed by a period of frequent sampling to establish the decay-curve for the glutamine tracer .", "Exogenous glutamine supplementation was given by intravenous infusion of a glutamine containing dipeptide , L-alanyl-L-glutamine , 0.28 g/kg during 20 hours .", "A 14 % increase of endogenous glutamine Ra was seen at the end of the intravenous supplementation period as compared to the basal measurements ( P = 0.009 ) .", "The bolus injection technique to measure glutamine Ra to estimate the endogenous production of glutamine in critically ill patients was demonstrated to be useful for repetitive measurements .", "The hypothesized attenuation of endogenous glutamine production during L-alanyl-L-glutamine infusion given as a part of full nutrition was not seen ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The purpose of this study was to evaluate the effect of the use of preoperative breast MRI on surgical and long-term outcomes among women with early-stage breast cancer undergoing breast conservation therapy .", "A retrospective review yielded the cases of 174 women with stage 0 , I , or II breast cancer who underwent preoperative MRI between 2000 and 2004 .", "A control group of 174 patients who did not undergo preoperative MRI before breast conservation therapy was matched by age , histopathologic finding , stage , and surgeon .", "Features compared included breast density , presence of mammographically occult disease , margin status , lymph node involvement , lymphovascular invasion , extensive intraductal component , hormone receptor status , and use of adjuvant therapy .", "Outcomes , including rates of reexcision , ipsilateral recurrence , and disease-free survival , were compared by Kaplan-Meier methods and the log-rank test .", "Patients referred for preoperative breast MRI were more likely to have extremely dense breasts ( 28 % vs 6 % , p < 0.0001 ) and mammographically occult cancer ( 24 % vs 9 % , p = 0.0003 ) .", "The two groups had identical rates of final negative margins , lymph node involvement , lymphovascular invasion , extensive intraductal component status , positive hormone receptor results , and systemic adjuvant therapy .", "Fewer patients in the preoperative MRI group needed reexcision ( 29 % vs 45 % , p = 0.02 ) .", "The median follow-up period after treatment was 8 years .", "There was no significant difference in locoregional recurrence ( p = 0.33 ) or disease-free survival ( p = 0.73 ) rates between the two groups .", "Reexcision rates among patients with early breast cancer undergoing conservation therapy were lower among women who underwent preoperative breast MRI .", "There was no statistically significant effect of the use of preoperative MRI on rates of locoregional recurrence or disease-free survival ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Pulmonary rehabilitation ( PR ) is an evidence-based intervention in patients with chronic obstructive pulmonary disease ( COPD ) which improves the exercise capacity and quality of life ( QoL ) .", "We studied 60 patients after an episode of acute exacerbation of COPD ( AECOPD ) .", "They were randomised to receive conventional treatment without pulmonary rehabilitation ( CTWPR ) ( n = 30 ) or , standard treatment plus a 12-week post-exacerbation pulmonary rehabilitation ( PEPR ) programme in addition .", "Assessment of exercise capacity by six minute walk test ( 6MWT ) and QoL measured by St George 's Respiratory Questionnaire ( SGRQ ) were carried out initially and at the end of three months .", "The baseline characteristics of both the groups were found to be similar .", "There was a statistically significant increase in the six minute walk distance ( 6MWD ) ( increase by 37.9 meters , p < 0.001 ) and a significant decline in the total SGRQ score ( by 3.8 units p < 0.001 ) in the PEPR group compared to CTWPR group .", "Early pulmonary rehabilitation in patients with an AECOPD has significant benefits on the QoL and exercise capacity ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "A phase IIa study investigated efficacy and safety/tolerability of ascending doses of mavrilimumab ( anti-granulocyte-macrophage colony-stimulating factor receptor [ GM-CSFR ] monoclonal antibody ) in adult subjects with moderate to severe rheumatoid arthritis from Japan and Europe .", "Findings from the Japanese population are presented .", "Fifty-one subjects received mavrilimumab ( 10-100 mg ) or placebo subcutaneously every other week for 12 weeks , followed by a 12-week follow-up period .", "The primary endpoint was the proportion of subjects achieving a Disease Activity Score using 28 joints ( DAS28 ) - C-reactive protein ( CRP ) response ( decrease > 1.2 from baseline ) .", "Secondary endpoints included DAS28-CRP remission , Health Assessment Questionnaire Disability Index ( HAQ-DI ) and American College of Rheumatology ( ACR ) response .", "By Week 12 , more mavrilimumab - versus placebo-treated subjects achieved a DAS28-CRP response ( 50.0 % vs. 23.5 % , p = 0.081 ) ; a significant response was seen in the 30 mg and 100 mg dose groups ( both 75.0 % vs. 23.5 % , p = 0.028 ) .", "The 100 mg group also demonstrated statistically significant HAQ-DI and ACR20 responses at Week 12 .", "Results were generally consistent between Japanese and European populations .", "Overall , adverse events ( AEs ) were mild to moderate in intensity with one serious AE of pneumonia , considered possibly treatment-related .", "A rapid and clinically meaningful response was seen in subjects treated with GM-CSFR blockade with mavrilimumab , supporting further investigation of mavrilimumab for the treatment of RA in Japanese subjects ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "We compared the antiinflammatory and cardioprotective effects of the two most common regimens of corticosteroid administration in pediatric cardiac surgical procedures : a single dose delivered either at anesthesia induction or by cardiopulmonary bypass ( CPB ) prime .", "Forty-five children , aged between 1 and 18 months and undergoing ventricular septal or atrioventricular septal defect correction , were randomized in double-blind fashion into three groups .", "The anesthesia induction group received 30 mg/kg methylprednisolone intravenously after anesthesia induction , and the CPB-prime group received 30 mg/kg methylprednisolone by CPB circuit .", "The placebo group received saline solution .", "Plasma concentrations of methylprednisolone , interleukin ( IL ) -6 , IL-8 and IL-10 , and troponin were measured at anesthesia induction before the study drug , 30 minutes on CPB , after patients were weaned from CPB , and 6 hours after cessation of CPB .", "Equally high methylprednisolone concentrations were detected in both methylprednisolone groups , but the measured peak concentration occurred earlier in the induction group .", "Significantly lower IL-8 concentrations were observed just after patients were weaned from and 6 hours after CPB in the anesthesia induction group compared with the placebo ( p = 0.002 , p = 0.001 ) and prime groups ( p = 0.003 , p = 0.006 ) .", "Significant reductions of troponin were detected in both methylprednisolone groups compared with placebo ( induction , p = 0.001 ; prime , p = 0.002 ) 6 hours after patients were weaned from CPB .", "Methylprednisolone administration at anesthesia induction was superior in terms of antiinflammatory action .", "Methylprednisolone administration in CPB-prime only a few minutes before aortic cross-clamping and cardioplegia resulted in mean troponin reductions similar to those of administration at anesthesia induction .", "Corticosteroids may have direct cardioprotective properties , as reported in experimental studies ." ]

[ "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To determine whether the postoperative administration of tryptophan would be beneficial for elderly adults undergoing surgery who are at risk of developing postoperative delirium .", "Randomized , double-blind , placebo-controlled trial .", "Denver Veterans Affairs Medical Center .", "Individuals aged 60 and older undergoing major elective operations requiring a postoperative intensive care unit ( ICU ) admission ( n = 325 ) .", "L-tryptophan , 1g orally three times a day or placebo was started after surgery and continued for up to 3days postoperatively .", "Delirium and its motor subtypes were measured using the Confusion Assessment Method-Intensive Care Unit ( CAM-ICU ) and the Richmond Agitation and Sedation Scale .", "The primary outcome for between-group comparison was the incidence of excitatory ( mixed and hyperactive ) postoperative delirium .", "The secondary outcomes for comparison were the incidence and duration of overall postoperative delirium .", "The overall incidence of postoperative delirium was 39 % ( 95 % confidence interval = 34-44 % ) ( n = 116 ) .", "Seventeen percent of participants in the tryptophan group and 9 % in the placebo group had excitatory delirium ( P = .18 ) , and the duration of excitatory delirium was 3.31.7 days for tryptophan and 3.11.9 days for placebo ( P = .74 ) .", "Forty percent of participants in the tryptophan group and 37 % in the placebo group had overall delirium ( P = .60 ) , and the duration of overall delirium was 2.91.8 days for tryptophan and 2.41.6 days for placebo ( P = .17 ) .", "Postoperative tryptophan supplementation in older adults undergoing major elective operations requiring postoperative ICU admission did not reduce the incidence or duration of postoperative excitatory delirium or overall delirium ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "Optimizing vancomycin dosing may help eradicate bacteria while avoiding resistance .", "The guidelines recommend loading doses ; however , there are no data to demonstrate that this may result in a more rapid achievement of therapeutic troughs .", "To evaluate the percentage of troughs reaching therapeutic levels at 12 , 24 , and 36 hours following an initial vancomycin dose of 30 mg/kg compared with 15 mg/kg .", "This prospective , randomized study was performed in a community academic medical center .", "Patients who were to receive vancomycin in the emergency department were randomized to an initial traditional dose of 15 mg/kg or a 30-mg/kg loading dose followed by 15 mg/kg every 12 hours for 3 doses .", "Patients weighing > 120 kg or with creatinine clearances < 50 mL/min were excluded .", "In total , 99 patients were enrolled ; 12 hours after the initial dose of vancomycin , there was a significantly greater proportion of patients reaching target trough levels of 15 mg/L among the patients who received a loading dose as compared with a traditional dose ( 34 % vs 3 % , P < 0.01 ) .", "This trend continued at 24 hours but was not statistically significant .", "At 36 hours , there was no difference in the percentage of patients reaching target levels between the 2 groups .", "No statistically significant difference in nephrotoxicity or adverse events among the 2 groups was demonstrated .", "A loading dose of 30 mg/kg of vancomycin achieved a higher percentage of therapeutic levels at 12 hours when compared with the traditional dose of 15 mg/kg , without increased nephrotoxicity or adverse events ." ]

[ "BACKGROUND", "BACKGROUND", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "United States pediatric guidelines recommend that childhood obesity counseling be conducted in the primary care setting .", "Primary care-based interventions can be effective in improving health behaviors , but also costly .", "The purpose of this study was to evaluate the cost of a primary care-based obesity prevention intervention targeting children between the ages of two and six years who are at elevated risk for obesity , measured against usual care .", "High Five for Kids was a cluster-randomized controlled clinical trial that aimed to modify children 's nutrition and TV viewing habits through a motivational interviewing intervention .", "We assessed visit-related costs from a societal perspective , including provider-incurred direct medical costs , provider-incurred equipment costs , parent time costs and parent out-of-pocket costs , in 2011 dollars for the intervention ( n = 253 ) and usual care ( n = 192 ) groups .", "We conducted a net cost analysis using both societal and health plan costing perspectives and conducted one-way sensitivity and uncertainty analyses on results .", "The total costs for the intervention group and usual care groups in the first year of the intervention were $ 65,643 ( 95 % CI [ $ 64,522 , $ 66,842 ] ) and $ 12,192 ( 95 % CI [ $ 11,393 , $ 13,174 ] ) .", "The mean costs for the intervention and usual care groups were $ 259 ( 95 % CI [ $ 255 , $ 264 ] ) and $ 63 ( 95 % CI [ $ 59 , $ 69 ] ) per child , respectively , for a incremental difference of $ 196 ( 95 % CI [ $ 191 , $ 202 ] ) per child .", "Children in the intervention group attended a mean of 2.4 of a possible 4 in-person visits and received 0.45 of a possible 2 counseling phone calls .", "Provider-incurred costs were the primary driver of cost estimates in sensitivity analyses .", "High Five for Kids was a resource-intensive intervention .", "Further studies are needed to assess the cost-effectiveness of the intervention relative to other pediatric obesity interventions ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "To investigate the efficacy of letrozole for delaying bone maturation and increasing predicted adult height in boys with idiopathic central precocious puberty ( ICPP ) who have a bone age above 13 years and a short stature , and its adverse effects .", "Twenty ICPP boys with a bone age above 13 years and a short stature were randomly divided into letrozole treatment ( n = 10 ) and control groups ( n = 10 ) .", "The letrozole treatment group received oral letrozole [ 2.5 mg / ( m ( 2 ) d ) , Qd ] for 6 months , while the control group received no treatment and was observed periodically .", "Bone age , growth rate , height standard deviation ( SD ) score , predicted adult height SD score , sexual maturity , and levels of follicle-stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , dehydroepiandrosterone , testosterone ( T ) , estradiol ( E2 ) , progesterone ( P ) , and androstenedione ( ASD ) were measured .", "The letrozole-related adverse reactions were evaluated .", "After 6 months of treatment , both groups had a significantly increased bone age , but the letrozole group had a significantly slowed increase in bone age compared with the control group ( 13.82 0.23 years vs 14.47 0.30 years ; P < 0.05 ) ; compared with the control group , the letrozole group had a significantly increased predicted adult height SD score ( -1.69 0.26 vs -1.91 0.35 ; P < 0.05 ) and a significantly increased T level ( 4.9 0.9 nmol/L vs 4.4 0.8 nmol/L ; P < 0.05 ) .", "There was no significant difference in testicular volume between the two groups .", "The treatment led to no significant changes in growth rate , Tanner stage , and levels of FSH , LH , P , E2 and ASD in the two groups , and there was no significant difference in these indices between the two groups .", "No adverse reactions were observed during letrozole treatment .", "Letrozole delays bone maturation and increases predicted adult height in ICPP boys with a bone age above 13 years and a short stature , and it causes no obvious adverse reactions ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "In percutaneous nephrolithotomy ( PCNL ) , placement of the access tract into the kidney is an important aspect of the procedure and is responsible for the steep learning curve associated with the operation .", "The aim of the current prospective randomized trial was to assess the duration of radiation exposure along with the safety and efficacy of PCNL done by a trainee , utilizing either ultrasonography ( US ) or fluoroscopic guidance to obtain access .", "Sixty-four patients with 3cm renal calculi undergoing single-tract PCNL by trainee urologists ( experience of < 25 PCNL 's ) were randomized into US - and fluoroscopic-guided access groups ( 32 in each ) .", "In Group 1 ( US guided ) , puncture was done using a 3.5 / 5MHz US probe with a puncture attachment , whereas the triangulation technique with biplanar C-arm fluoroscopy was utilized in group 2 ( fluoroscopic guided ) .", "Patient demographics , stone parameters , intraoperative characteristics , fluoroscopy durations , and postoperative outcomes were analyzed .", "Both groups were comparable as far as patient and stone characteristics were concerned .", "The fluoroscopy exposure during the puncture phase ( T2 ) and overall ( T ) was significantly lower in the US group at 9.020.8 vs 43.834.8 , ( p < 0.0001 ) and 204.384 vs 239.977.5 , ( p = 0.04 ) .", "Six patients in group1 required fluoroscopic adjustment ( p = 0.03 ) .", "All other intra - and postoperative parameters were similar in both the groups .", "Both ultrasound and fluoroscopic guidance for renal access are equally safe and feasible in the hands of a trainee urologist .", "Total fluoroscopy duration and exposure time during puncture were both significantly less in the ultrasound group .", "Expertise in fluoroscopic-guided access is essential for a novice to effectively achieve access in all possible situations ." ]

[ "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Hangeshashinto ( TJ-14 , a Kampo medicine ) , which reduces the level of prostaglandin E2 and affects the cyclooxygenase activity , alleviates chemotherapy-induced oral mucositis ( COM ) .", "We conducted a randomized comparative trial to investigate whether TJ-14 prevents and controls COM in patients with gastric cancer .", "We randomly assigned patients with gastric cancer who developed moderate-to-severe oral mucositis ( CTCAE v4 .0 grade 1 ) during any cycle of chemotherapy to receive either TJ-14 or a placebo as a double-blind trial .", "The patients received a placebo or TJ-14 for 2-6 weeks according to the chemotherapy regimen from the beginning of the next course of chemotherapy .", "The primary end point was the incidence of grade 2 oral mucositis in the protocol treatment course , and the secondary end points were the time to disappearance of oral mucositis and the incidence of adverse events .", "Following the key opening of the blinding protocol , we analyzed 91 eligible patients ( TJ-14 : 45 , placebo : 46 ) using a `` per protocol set '' analysis .", "The incidence of grade 2 COM was 40.0 % in the TJ-14 group and 41.3 % in the placebo group ( p = 0.588 ) .", "The median duration of grade 2 COM was 14 days in the TJ-14 group and 16 days in the placebo group ( p = 0.894 ) .", "Meanwhile , the median duration of any grade of COM was 9 days in the TJ-14 group and 17 days in the placebo group among the patients who developed grade 1 symptoms during the screening cycle [ hazard ratio 0.60 ; 95 % CI ( 0.23-1 .59 ) , p = 0.290 ] .", "Although TJ-14 treatment did not reduce the incidence of 2 COM in the patients who developed mucositis during chemotherapy for gastric cancer , a trend was observed in which TJ-14 reduced the risk of COM in the patients who developed grade 1 COM during the screening cycle .", "Further , phase III studies with a larger sample size are needed to clarify the protective effects of TJ-14 for COM ." ]

[ "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "Genetic information , typically communicated in-person by genetic counselors , can be challenging to comprehend ; delivery of this information online -- as is becoming more common -- has the potential of increasing these challenges .", "To address the impact of the mode of delivery of genomic risk information , 300 individuals were recruited from the general public and randomized to receive genomic risk information for type 2 diabetes mellitus in-person from a board-certified genetic counselor or online through the testing company 's website .", "Participants were asked to indicate their genomic risk and overall lifetime risk as reported on their test report as well as to interpret their genomic risk ( increased , decreased , or same as population ) .", "For each question , 59 % of participants correctly indicated their risk .", "Participants who received their results in-person were more likely than those who reviewed their results on-line to correctly interpret their genomic risk ( 72 vs. 47 % , p = 0.0002 ) and report their actual genomic risk ( 69 vs. 49 % , p = 0.002 ) .", "The delivery of personal genomic risk through a trained health professional resulted in significantly higher comprehension .", "Therefore , if the online delivery of genomic test results is to become more widespread , further evaluation of this method of communication may be needed to ensure the effective presentation of results to promote comprehension ." ]

[ "BACKGROUND", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "A high prevalence of hyperandrogenism has been reported in women with type 1 diabetes ( T1D ) .", "Metformin has been used as a therapeutic agent in patients with polycystic ovarian syndrome and in T1D patients without hyperandrogenism .", "This study sought to determine the effect of metformin on hyperandrogenism and ovarian function in adolescents with T1D .", "We recruited 24 girls with T1D .", "The participants had hyperandrogenism and displayed suboptimal metabolic control .", "The patients were enrolled in a randomized , double-blind , placebo-controlled trial .", "One group received metformin ( 850 mg bid ) and the other group received a placebo .", "Treatment was administered for 9 months .", "Ovulation , steroids and gonadotropin levels were evaluated .", "Metformin treatment was associated with decreases in testosterone , free androgen index , androstenedione , 17-OH progesterone and estradiol levels .", "The girls who were treated with placebo showed stable steroid , gonadotropin and sex hormone-binding globulin levels during the analysis .", "No differences were observed in the Ferriman-Gallwey scores , ovulation rates , HbA1c levels or daily insulin doses of the girls treated with metformin compared with the placebo group .", "Treating hyperandrogenic T1D adolescents with metformin significantly decreased the serum androgens compared to the placebo , but metformin therapy did not significantly affect clinical parameters , such as hirsutism , ovulation and metabolic control ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "To explore the dynamics of aggregation of platelets and erythrocytes , their deformity and computed morphodensitometric parameters in patients with chronic cerebral ischemia , stages I and II , treated with cerebrolysin .", "We examined 300 patients , including 87 men and 213 women , aged from 30 to 55 years .", "Patients were randomized by disease stage and treatment ( standard treatment with or without cerebrolysin ) .", "The dynamics of neurological and emotional status as well as cognitive functions and results of laboratory studies were assessed .", "Along with the total positive effect of cerebrolysin on the clinical picture , additional mechanisms of its action ( antiaggregant , antihypoxic and membranotropic ) improved the erythrocyte morphodensitometric parameters , hemostatic , hemorheological and blood gas transport characteristics , in particular on the microcirculatory level ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "METHODS", "CONCLUSIONS" ]

[ "The Secondary Prevention of Small Subcortical Stroke trial ( SPS3 ) recruited participants meeting clinical and radiological criteria for symptomatic lacunes .", "Individuals randomized to dual antiplatelet therapy with clopidogrel and aspirin had an unanticipated increase in all-cause mortality compared with those assigned to aspirin .", "We investigated the factors associated with mortality in this well-characterized population .", "We identified independent predictors of mortality among baseline demographic and clinical factors by Cox regression analysis in participants of the SPS3 trial .", "Separately , we examined the effect on mortality of nonfatal bleeding during the trial .", "During a mean follow-up of 3.6 years , the mortality rate was 1.78 % per year for the 3020 participants ( mean age , 63 years ) .", "Significant independent predictors of mortality at study entry were age , diabetes mellitus , history of hypertension , systolic blood pressure ( hazard ratio [ HR ] , 1.3 per 20 mm Hg increase ) , serum hemoglobin < 13 g/dL ( HR , 1.6 ) , renal function ( HR , 1.3 per estimated glomerular filtration rate decrease of 20 mL/min ) , and body mass index ( HR , 1.8 per 10 kg/m2 decrease ) .", "Participants with ischemic heart disease ( P = 0.01 for interaction ) and normotensive/prehypertensive participants ( P = 0.03 for interaction ) were at increased risk if assigned to dual antiplatelet therapy .", "Nonfatal major hemorrhage increased mortality in both treatment arms ( HR , 4.5 ; 95 % confidence interval , 3.1-6 .6 ; P < 0.001 ) .", "Unexpected interactions between assigned antiplatelet therapy and each of ischemic heart disease and normal/prehypertensive status accounted for increased mortality among patients with recent lacunar stroke given dual antiplatelet therapy .", "Despite extensive exploratory analyses , the mechanisms underlying these interactions are uncertain .", "http://www.SPS3ClinicalTrials.gov .", "Unique identifier : NCT00059306 ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND", "BACKGROUND" ]

[ "To investigate the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in patients with Type2 diabetes mellitus inadequately controlled by a combination of metformin and pioglitazone .", "This was a multi-centre , phase3 , randomized , double-blind , placebo-controlled study comparing linagliptin 5mg once daily ( n = 183 ) and placebo ( n = 89 ) as add-on to metformin and pioglitazone .", "The primary endpoint was the change from baseline in glycated haemoglobin ( HbA1c ) after 24weeks .", "The placebo-corrected adjusted mean ( se ) change in HbA1c from baseline to 24weeks was -6 ( 1 ) mmol/mol [ -0.57 ( 0.13 ) % ] ( P < 0.0001 ) .", "In patients with baseline HbA1c 53mmol/mol ( 7.0 % ) , 32.4 % of patients in the linagliptin group and 13.8 % in the placebo group achieved HbA1c < 53mmol/mol ( 7.0 % ) ( odds ratio2 .94 ; P = 0.0033 ) .", "The placebo-corrected adjusted mean ( se ) change from baseline in fasting plasma glucose at week24 was -0.57 ( 0.26 ) mmol/l [ -10.4 ( 4.7 ) mg/dl ] ( P = 0.0280 ) .", "The incidence of serious adverse events was 2.2 % with linagliptin and 3.4 % with placebo .", "Investigator-defined hypoglycaemia occurred in 5.5 % of the linagliptin group and 5.6 % of the placebo group .", "No meaningful changes in mean body weight were noted for either group .", "Linagliptin as add-on therapy to metformin and pioglitazone produced significant and clinically meaningful improvements in glycaemic control , without an additional risk of hypoglycaemia or weight gain ( Clinical Trials Registry No : NCT 00996658 ) ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS" ]

[ "The study aimed at comparing the effectiveness and maternal satisfaction of oral misoprostol with vaginal misoprostol for induction of labor at term .", "A randomized controlled trial of 140 term pregnant women at the University of Nigeria Teaching Hospital Enugu , Nigeria , was conducted from April 2011 to May 2012 .", "The women were equally randomized into two groups ( A and B ) to receive oral and vaginal misoprostol , respectively .", "The vaginal route reduced the mean induction-vaginal delivery interval by four-and-half hours ( 20.7 12.1 vs. 16.2 10.4 ; mean difference : 4.50 , 95 % CI 0.63-0 .82 ; p = 0.02 ) .", "Furthermore , the mean dose of misoprostol required to achieve induction of labor and the mean duration of oxytocin augmentation when indicated were significantly less in the vaginal group than in the oral group ( 2.5 1.3 vs. 2.0 1.1 ; mean difference : 0.50 , 95 % CI 0.10-0 .90 ; p = 0.02 and 4.6 3.2 vs. 3.4 3.1 ; mean difference : 1.20 , 95 % CI 0.15-0 .23 ; p = 0.03 respectively ) .", "However , neonatal complications and maternal satisfaction were similar between the two groups .", "Both routes of administration are effective in the induction of labor at term and have comparable maternal satisfaction .", "However , the vaginal route has the added advantage of shorter induction-delivery interval among others , and thus should be highly considered when induction of labor is indicated at term ." ]

[ "OBJECTIVE", "METHODS", "METHODS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS" ]

[ "The incidence of acute kidney injury ( AKI ) is increasing globally and it is much more common than end-stage kidney disease .", "AKI is associated with high mortality and cost of hospitalisation .", "Studies of treatments to reduce this high mortality have used differing renal replacement therapy ( RRT ) modalities and have not shown improvement in the short term .", "The reported long-term outcomes of AKI are variable and the effect of differing RRT modalities upon them is not clear .", "We used the prolonged follow-up of a large clinical trial to prospectively examine the long-term outcomes and effect of RRT dosing in patients with AKI .", "We extended the follow-up of participants in the Randomised Evaluation of Normal vs. Augmented Levels of RRT ( RENAL ) study from 90 days to 4 years after randomization .", "Primary and secondary outcomes were mortality and requirement for maintenance dialysis , respectively , assessed in 1,464 ( 97 % ) patients at a median of 43.9 months ( interquartile range [ IQR ] 30.0-48 .6 months ) post randomization .", "A total of 468/743 ( 63 % ) and 444/721 ( 62 % ) patients died in the lower and higher intensity groups , respectively ( risk ratio [ RR ] 1.04 , 95 % CI 0.96-1 .12 , p = 0.49 ) .", "Amongst survivors to day 90 , 21 of 411 ( 5.1 % ) and 23 of 399 ( 5.8 % ) in the respective groups were treated with maintenance dialysis ( RR 1.12 , 95 % CI 0.63-2 .00 , p = 0.69 ) .", "The prevalence of albuminuria among survivors was 40 % and 44 % , respectively ( p = 0.48 ) .", "Quality of life was not different between the two treatment groups .", "The generalizability of these findings to other populations with AKI requires further exploration .", "Patients with AKI requiring RRT in intensive care have high long-term mortality but few require maintenance dialysis .", "Long-term survivors have a heavy burden of proteinuria .", "Increased intensity of RRT does not reduce mortality or subsequent treatment with dialysis .", "www.ClinicalTrials.govNCT00221013 ." ]

[ "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "BACKGROUND", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "RESULTS", "CONCLUSIONS", "CONCLUSIONS", "CONCLUSIONS", "BACKGROUND" ]

[ "The incidence of non-alcoholic fatty liver disease ( NAFLD ) is increasing dramatically affecting up to 30 % of the population worldwide .", "At present , treatment options are limited and pharmacological management of NAFLD has had disappointing results .", "Some of the best available evidence to improve NAFLD concerns lifestyle modification .", "To detect the degree of weight reduction needed to improve the markers of hepatic function and insulin resistance in type-2 diabetics with NAFLD .", "One hundred type-2 diabetic male patients with NAFLD were included into this study and divided into two equal groups .", "Group ( A ) received aerobic exercise training in addition to diet regimen .", "Group ( B ) received no treatment intervention .", "There was a 26.99 % , 40.8 % , 33.81 % , 32.73 % , 37.8 % and 15 % reduction in mean values of Alkaline Phosphatase ( ALP ) , Alanine Aminotransferase ( ALT ) , Aspartate Aminotransferase ( AST ) , Gamma - Glutamyltransferase ( GGT ) and Homeostasis Model Assessment-Insulin Resistance-index ( HOMA-IR ) and BMI respectively in group ( A ) at the end of the study .", "While there were significant differences between mean levels of the investigated parameters in group ( A ) and group ( B ) after treatment .", "About 15 % reduction in BMI is effective to improve the liver condition and insulin resistance in type-2 diabetics with NAFLD ." ]

[ "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "OBJECTIVE", "METHODS", "METHODS", "METHODS", "RESULTS", "RESULTS", "CONCLUSIONS" ]