Oral udenafil was deemed safe and effective for the treatment of erectile dysfunction in patients who underwent TME for rectal cancer .


The aim of this study was to compare the effect of continuous care model with routine care on the quality of life among patients who receive a kidney transplant .


In a randomized clinical trial , 90 kidney transplant patients were selected from 4 hospitals in Tehran , Iran , and were randomly assigned to 2 group .


In the experimental group , continuous care model was applied for 3 months and the control group received routine care .


The scale scores of the Kidney Transplant Questionnaire concerning quality of life were monthly compared between the two groups .


Of 90 patients , 4 in the experimental and 8 in the control group were excluded from the study .


Final analysis was performed on 41 in the experimental and 37 in the control groups .


No significant difference was found between the two groups in terms of demographic variables .


Although the quality of life scores increased in both groups , the mean scores of the experimental group were significantly higher than those in the control group at 1 , 2 , and 3 months .


Continuous care model may improve the kidney transplant patients ' quality of life .


Hilar cholangiocarcinoma is an uncommon cancer and its overall incidence is increasing .


Photodynamic therapy ( PDT ) has been proposed as palliative management for unresectable hilar cholangiocarcinoma ( UHC ) .


To date , little is known about the role of the addition of systemic chemotherapy to PDT for UHC .


We performed a prospective , randomised , phase II trial to compare PDT plus S-1 and PDT alone for UHC .


Patients with UHC were randomly assigned ( in a 1:1 ratio ) to PDT plus S-1 or PDT alone .


The primary end-point was overall survival .


The secondary end-points were progression-free survival , complications , re-intervention rate and quality of life .


This trial is registered with clinicalTrials.gov , number NCT00869635 .


Between February 2009 and May 2012 , we randomly assigned 21 patients to receive PDT plus S-1 and 22 to receive PDT alone .


The UHC patients treated with PDT plus S-1 showed higher 1-year survival rate compared with the patients treated with PDT alone ( 76.2 % versus 32 % , P = 0.003 ) and prolonged overall survival ( median 17 months , 95 % confidence interval [ CI ] : 12.6-21 .4 , versus 8 months , 95 % CI : 6-10 , P = 0.005 , hazard ratio [ HR ] , 0.36 ; 95 % CI : 0.17-0 .75 ) .


Regarding the secondary end-points , PDT plus S-1 was associated with prolonged progression-free survival compared with PDT alone ( median 10 months [ 95 % CI : 4.1-16 ] versus 2 months [ 95 % CI : 0.4-3 .5 ] , P = 0.009 ( HR for progression 0.39 , 95 % CI : 0.19-0 .83 ) .


There were no differences in the number of PDT sessions , the frequency of cholangitis , overall adverse events or the quality of life in either group .


PDT plus S-1 was well tolerated and was associated with a significant improvement of overall survival and progression-free survival compared with PDT alone in patients with UHC .


These findings warrant further clinical investigation of PDT plus S-1 in patients with UHC .


Patient centred and individually-tailored counselling of older people with a chronic condition who live at home is a useful intervention to support their independence .


The paper presents the development and psychometric testing of the APN-BQ Instrument , to measure patient-centeredness .


To measure the quality of an in-home counselling intervention , a 23-item questionnaire was developed and tested with 206 people 80 years and older .


Principal component analysis with Varimax Rotation was conducted ( n = 206 ) .


Analysis revealed a four factor ( fs = 0.91 ) model scoring in 19 items .


All factors loaded > 0.45 .


Cronbach 's alpha was 0.86 .


The utility and acceptance of the instrument was confirmed by the high response rate ( 100 % ) and the fact that participants answered 98.8 % of all questions .


The APN-BQ has shown to be a reliable Instrument with good content and construct validity .


It is a tool for APNs to measure structure , process , and outcome quality of a patient-centred and individually-tailored counselling program , including the degree of patient participation , and patient empowerment .


To compare the efficacy of two different techniques for vertical bone regeneration at implant placement with particulate autogenous bone at 6 years after loading by means of a double-blind , superiority , parallel-group randomized clinical trial .


The study was conducted in a private center in Italy between April 2004 and December 2011 .


Patients in whom vertical bone augmentation was indicated in combination with the placement of single or multiple implants were eligible for inclusion in this trial .


Patients were randomized to receive either resorbable collagen barriers supported by an osteosynthesis plate ( test group ) or nonresorbable titanium-reinforced expanded polytetrafluoroethylene barriers ( control group ) .


The outcome variables-radiographic bone variation at implant sites , implant failures , and complications - were evaluated 6 years after loading .


Randomization was done by computer , with allocation concealed by opaque sequentially numbered sealed envelopes .


The patients and the radiographic examiner were blinded to group assignment .


Twenty-two patients were randomized : 11 to the resorbable barrier group and 11 to the nonresorbable ( control ) group .


One control group patient dropped out .


The mean bone level 6 years after surgery was 1.33 mm for the resorbable group and 1.00 mm for the nonresorbable group .


The adjusted difference in bone changes between groups was 0.15 mm ( 95 % confidence interval , -0.39 to 0.69 , P = .5713 ) .


No implant failures or complications occurred after loading .


No differences were observed in this comparison of resorbable and nonresorbable barriers with simultaneous implant placement for vertical ridge augmentation .


Effective maintenance therapies after chemoradiotherapy for lung cancer are lacking .


Our aim was to investigate whether the MUC1 antigen-specific cancer immunotherapy tecemotide improves survival in patients with stage III unresectable non-small-cell lung cancer when given as maintenance therapy after chemoradiation .


The phase 3 START trial was an international , randomised , double-blind trial that recruited patients with unresectable stage III non-small-cell lung cancer who had completed chemoradiotherapy within the 4-12 week window before randomisation and received confirmation of stable disease or objective response .


Patients were stratified by stage ( IIIA vs IIIB ) , response to chemoradiotherapy ( stable disease vs objective response ) , delivery of chemoradiotherapy ( concurrent vs sequential ) , and region using block randomisation , and were randomly assigned ( 2:1 , double-blind ) by a central interactive voice randomisation system to either tecemotide or placebo .


Injections of tecemotide ( 806 g lipopeptide ) or placebo were given every week for 8 weeks , and then every 6 weeks until disease progression or withdrawal .


Cyclophosphamide 300 mg/m ( 2 ) ( before tecemotide ) or saline ( before placebo ) was given once before the first study drug administration .


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


This study is registered with ClinicalTrials.gov , number NCT00409188 .


From Feb 22 , 2007 , to Nov 15 , 2011 , 1513 patients were randomly assigned ( 1006 to tecemotide and 507 to placebo ) .


274 patients were excluded from the primary analysis population as a result of a clinical hold , resulting in analysis of 829 patients in the tecemotide group and 410 in the placebo group in the modified intention-to-treat population .


Median overall survival was 25.6 months ( 95 % CI 22.5-29 .2 ) with tecemotide versus 22.3 months ( 19.6-25 .5 ) with placebo ( adjusted HR 0.88 , 0.75-1 .03 ; p = 0.123 ) .


In the patients who received previous concurrent chemoradiotherapy , median overall survival for the 538 ( 65 % ) of 829 patients assigned to tecemotide was 30.8 months ( 95 % CI 25.6-36 .8 ) compared with 20.6 months ( 17.4-23 .9 ) for the 268 ( 65 % ) of 410 patients assigned to placebo ( adjusted HR 0.78 , 0.64-0 .95 ; p = 0.016 ) .


In patients who received previous sequential chemoradiotherapy , overall survival did not differ between the 291 ( 35 % ) patients in the tecemotide group and the 142 ( 35 % ) patients in the placebo group ( 19.4 months [ 95 % CI 17.6-23 .1 ] vs 24.6 months [ 18.8-33 .0 ] , respectively ; adjusted HR 1.12 , 0.87-1 .44 ; p = 0.38 ) .


Grade 3-4 adverse events seen with a greater than 2 % frequency with tecemotide were dyspnoea ( 49 [ 5 % ] of 1024 patients in the tecemotide group vs 21 [ 4 % ] of 477 patients in the placebo group ) , metastases to central nervous system ( 29 [ 3 % ] vs 6 [ 1 % ] ) , and pneumonia ( 23 [ 2 % ] vs 12 [ 3 % ] ) .


Serious adverse events with a greater than 2 % frequency with tecemotide were pneumonia ( 30 [ 3 % ] in the tecemotide group vs 14 [ 3 % ] in the placebo group ) , dyspnoea ( 29 [ 3 % ] vs 13 [ 3 % ] ) , and metastases to central nervous system ( 32 [ 3 % ] vs 9 [ 2 % ] ) .


Serious immune-related adverse events did not differ between groups .


We found no significant difference in overall survival with the administration of tecemotide after chemoradiotherapy compared with placebo for all patients with unresectable stage III non-small-cell lung cancer .


However , tecemotide might have a role for patients who initially receive concurrent chemoradiotherapy , and further study in this population is warranted .


Merck KGaA ( Darmstadt , Germany ) .


To determine efficacy and safety of treatment with Rituximab and Etanercept plus Methotrexate in patients with active Rheumatoid Arthritis ( RA ) , who had an inadequate response to nonbiologic DMARDS therapies and to explore the pharmacogenetics and pharmacodynamics of Rituximab and Etanercept in our populations .


Study was done at Rheumatology Clinic of University Clinical Centre in Prishtina during 2009-2011 years .


We evaluated primary efficacy and safety at 24 weeks in patients enrolled in the study of long-term efficacy of Rituximab and Etanercept .


Patients with active Rheumatoid Arthritis and an inadequate response to 1 or more non biologic DMARDS were randomized to receive intravenous Rituximab ( 1 course consisting of 2 infusions of 1.000 mg each - one group , and Etanercept 25 mg twice weekly - second group , but both groups with background MTX .


The primary efficacy end point was a response on the ACR 20 % , improvement criteria at 24 weeks , Secondary end points were responses on the ACR 50 and ACR 70 , improvement criteria , the DAS 28 , and EULAR response criteria at 24 weeks .


During our investigations we treated 20 patients , 15 females and 5 males , in the treated group with RTX and 13 patients 8 females and 5 males in the treated group with ETN .


Patients of group 1 and group 2 were of ages 37-69 years old and 19-69 years old ( average 47-44 ) Most of the patients belong in 2nd and 3rd functional stage according to Steinbrocker .


All ACR response parameters were significantly improved in RTX treated patients who also had clinically meaningful improvement in fatigue , disability and quality of life .


Patients showed a trend less progression in radiographic end points .


Most adverse events occurred with the first RTX infusion and were mild to moderate severity .


At 24 weeks , a single course of RTX and ETN provided significant and clinically meaningful improvements in disease activity in patients with active , longstanding RA who had an inadequate response to 1 or more nonbiologic DMARDS .


Oesophageal squamous cell carcinoma ( ESCC ) is a fatal disease with 5-year survival rates of < 5 % in Northern Iran .


Oesophageal squamous dysplasia ( ESD ) is the precursor histologic lesion of ESCC .


This pilot study was conducted to assess the feasibility , safety , and acceptability of non-endoscopic cytological examination of the oesophagus and to provide initial data on the accuracy of cytological atypia for identifying patients with ESD in this very-high-risk area .


Randomly selected asymptomatic participants of the Golestan Cohort Study were recruited .


A cytological specimen was taken using a capsule sponge device and evaluated for atypical cells .


Sections of the cytological specimen were also stained for p53 protein .


Patient acceptability was assessed using a visual analogue scale .


The cytological diagnosis was compared with a chromoendoscopic examination using Lugol 's solution .


Three hundred and forty-four subjects ( 43 % male , mean ( s.d. ) age 55.6 ( 7.9 ) years ) were referred to the study clinic .


Three hundred and twelve met eligibility criteria and consented , of which 301 subjects ( 96.5 % ) completed both cytological and endoscopic examinations .


There were no complications .


Most of the participants ( 279 ; 92.7 % ) were satisfied with the examination .


The sensitivity and specificity of the cytological examination for identifying subjects with high-grade ESD were 100 and 97 % , respectively .


We found an accuracy of 100 % ( 95 % CI = 99-100 % ) for a combination of cytological examination and p53 staining to detect high-grade ESD .


The capsule sponge methodology seems to be a feasible , safe , and acceptable method for diagnosing precancerous lesions of the oesophagus in this population , with promising initial accuracy data for the detection of high-grade ESD .


To study the possibility of desflurane use for induction of anesthesia .


We analysed the intra - and immediate postoperative periods in 125 patients .


Depending on the intended anesthesia method patients were randomised ( the method of the envelopes ) and included in one of two study groups : 1 -- volatile desflurane-based anesthesia ( n = 62 ) ; 2 -- volatile sevoflurane-based anesthesia ( n = 63 ) .


Desflurane based anesthesia led to apnea until the installation of laryngeal mask in 94.5 % of patients ( of 54 ) , for whom a completion of inhalation induction was possible , whereas sevoflurane based anesthesia.led to apnea occurred only in one patient ( 1.6 % ) .


`` Step up '' desflurane-based inhalational induction and sevoflurane-based maximum concentration inhalational induction `` without primaryfilling of the circuit '' showed no significant in time necessary for achieving an anesthetic concentration essential for LMA installation .


In both groups it was 3-5 min .


desflurane-based volatile induction with addition of fentanyl led to apnea in 97 % of patients and associates with a higher risk of bronchospasm .


Social psychological theories provide bases for understanding how social comparison processes may impact peer influence .


This study examined two peer characteristics that may impact peer influence on adolescent girls ' weight-related behavior intentions : body size and popularity .


A school-based sample of 66 9th grade girls ( 12-15 years old ) completed an experimental paradigm in which they believed they were interacting with other students ( i.e. , `` e-confederates '' ) .


The body size and popularity of the e-confederates were experimentally manipulated .


Participants were randomly assigned to one of the three experimental conditions in which they were exposed to identical maladaptive weight-related behavior norms communicated by ostensible female peers who were either : ( 1 ) Thin and Popular ; ( 2 ) Thin and Average Popularity ; or ( 3 ) Heavy and Average Popularity .


Participants ' intent to engage in weight-related behaviors was measured pre-experiment and during public and private segments of the experiment .


A significant effect of condition on public conformity was observed .


Participants exposed to peers ' maladaptive weight-related behavior norms in the Heavy and Average condition reported significantly less intent to engage in weight-related behaviors than participants in either of the thin-peer conditions ( F ( 2 ) = 3.93 , p = .025 ) .


Peer influence on private acceptance of weight-related behavior intentions was similar across conditions ( F ( 2 ) = .47 , p = .63 ) .


Body size comparison may be the most salient component of peer influence processes on weight-related behaviors .


Peer influence on weight-related behavior intention also appears to impact private beliefs .


Considering peer norms in preventive interventions combined with dissonance-based approaches may be useful .


To compare the capability to aid prediction of clinical outcome measures , including progression-free survival ( PFS ) and overall survival ( OS ) , between volumetric estimates from contrast material-enhanced ( CE ) T1-weighted subtraction maps and traditional segmentation in a randomized multicenter clinical trial of recurrent glioblastoma ( GBM ) patients treated with bevacizumab .


All patients participating in this study signed institutional review board-approved informed consent at their respective institutions prior to enrolling in the multicenter clinical trial .


One-hundred sixty patients with recurrent GBM enrolled as part of a HIPAA-compliant , multicenter clinical trial ( AVF3708 g , BRAIN trial ) .


Contrast-enhancing tumor volumes and change in volumes as a response to therapy were quantified by using either conventional segmentation or CE T1-weighted subtraction maps created by voxel-by-voxel subtraction of intensity-normalized nonenhanced T1-weighted images from CE T1-weighted images .


These volumes were then tested as predictors of PFS and OS by using log-rank univariate analysis , the multivariate Cox proportional hazards regression model , and receiver operating characteristic analysis .


Use of CE T1-weighted subtraction maps qualitatively improved visualization and improved quantification of tumor volume after bevacizumab treatment .


Significant trends between the volume of tumor and change in tumor volume after therapy on CE T1-weighted subtraction maps were found for both PFS and OS ( pretreatment volume < 15 cm ( 3 ) , P < .003 ; posttreatment volume < 7.5 cm ( 3 ) , P < .05 ; percentage change in volume > 25 % , P = .004 for PFS and P = .053 for OS ) .


CE T1-weighted subtraction maps were significantly better at aiding prediction of 6-month PFS and 12-month OS compared with conventional segmentation by using receiver operating characteristic analysis ( P < .05 ) .


Use of CE T1-weighted subtraction maps improved visualization and aided better prediction of patient survival in recurrent GBM treated with bevacizumab compared with conventional segmentation of CE T1-weighted images .


Clinical trial registration no .


NCT00345163 .


Online supplemental material is available for this article .


The objective was to explore the role of specific patient-related and operator-related factors in pain perception during flexible laryngoscopy , which is one of the most common ENT procedures .


Monocentric , randomized , individual prospective study .


A total of 532 patients ( 145 men and 387 women ) , without any relevant ENT diseases , underwent laryngoscopy performed by otolaryngologists with various degrees of experience .


Patient discomfort was reported using visual analog scores , and willingness to repeat the experience was also recorded .


Statistical analysis showed that greater pain was significantly associated with female patients and female otolaryngologists , whereas the pain was less severe in the cases of experienced laryngologists and older patients .


Pain plays an important role in determining the willingness to repeat the examination ; in fact , patients who experienced lower levels of pain during laryngoscopy were more prone to repeat the experience .


This article explores the importance of the extrinsic factors that are related to the patient and the otolaryngologist in determining the level of pain associated with laryngoscopy .


Our study indicated that laryngoscopy is generally a well-tolerated procedure , causing little overall discomfort , but that a subgroup of patients may experience more pain than others , which may affect the patient 's perspective toward undergoing a similar future experience .


Our analysis may be helpful for clinicians in understanding pain perception during a routine procedure , enabling them to focus more on that subgroup of patients who are more prone to pain .


1b .


The efficacy and safety of sublingual immunotherapy in house dust mite-induced asthma have yet to be firmly established .


We report the results of a double-blind , placebo-controlled , randomized clinical trial performed in mainland China .


After a three-month baseline period , 484 asthmatic adults were randomized 2:1 to 12months of daily treatment with either an aqueous , standardized , 300 index of reactivity mixture of Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts or a placebo .


The primary efficacy criterion was well-controlled asthma for at least 16 of the last 20weeks of treatment .


In the active ( n = 308 ) and placebo ( n = 157 ) groups , well-controlled asthma was achieved by 85.4 % and 81.5 % of the patients , respectively ( P = 0.244 ) .


A subsequent post hoc analysis by asthma severity revealed significant clinical benefits in actively treated subjects with moderate , persistent asthma at baseline [ 401-800g budesonide/day ( n = 175 ) ] , with greater achievement of well-controlled asthma ( 80.5 % and 66.1 % for the active treatment and placebo groups , respectively ; P = 0.021 ) and totally controlled asthma ( 54.0 % and 33.9 % , respectively , P = 0.008 ) , a higher percentage of patients with an asthma control questionnaire score < 0.75 ( 56.6 % and 40.0 % , respectively ; P = 0.039 ) and a greater mean reduction in inhaled corticosteroid use ( 218.5 g and 126.2 g , respectively ; P = 0.004 ) .


The active vs placebo differences in disease control and corticosteroid use were not significant for mild , persistent asthma .


No treatment-related serious adverse events were reported .


Sublingual mite allergen immunotherapy was well tolerated in adult asthmatics and effectively controlled disease in patients with moderate ( but not mild ) persistent asthma ( ClinicalTrials.gov : NCT00660452 ) .


The high prevalence and incidence of obesity and eating disorders in US adolescent girls are serious health problems .


Because of the shared risk factors for obesity and eating disorders , a targeted prevention of both conditions is a priority .


We determined whether an adapted interpersonal psychotherapy prevention program is more efficacious for reducing excess weight gain and worsening disordered eating than health education in adolescent girls at high risk of obesity and eating disorders .


A parallel-group , randomized controlled trial was conducted between September 2008 and January 2013 in a university-based laboratory and a federal research hospital .


The study included 113 adolescent ( 12-17-y-old ) girls deemed at high risk of adult obesity and eating disorders because of a body mass index ( BMI ) between the 75th and 97th percentiles and reports of episodes of a loss of control over their eating .


Girls were randomly assigned to participate in an adapted interpersonal psychotherapy or a health-education group program for 12 weekly 90-min group sessions .


Follow-up assessments occurred immediately after group programs and at 6 and 12 mo. .


Participation in both conditions was associated with decreases in expected BMI gain , age-adjusted BMI metrics , the percentage of fat by using dual-energy X-ray absorptiometry , symptoms of depression and anxiety , and the frequency of loss-of-control eating over 12 mo of follow-up ( Ps < 0.001 ) with no group difference .


In follow-up analyses , interpersonal psychotherapy was more efficacious than health education at reducing objective binge eating at the 12-mo follow-up ( P < 0.05 ) .


The intervention with adolescent girls with loss-of-control eating is associated with lower age-adjusted BMI and percentage of adiposity as well as improved mood symptoms over 1 y. Interpersonal psychotherapy further reduced objective binge eating .


Additional research is needed to elucidate the mechanisms by which physical and psychological improvements were observed .


This trial was registered at clinicaltrials.gov as NCT00680979 .


Conservative orthotic treatments rely on different mechanisms , such as three-point bending systems or hinges forcing external rotation of the leg and knee stabilization , to alter the biomechanics of the lower limbs and thus reduce knee loading on the affected compartment in patients with knee osteoarthritis ( KOA ) .


No previous study had compared the effects of these mechanisms on external loading and leg kinematics in patients with KOA .


Twenty-four patients with medial KOA ( Kellgren-Lawrence grade II or III ) wore three custom knee braces : a valgus brace with a three-point bending system ( V3P-brace ) , an unloader brace with valgus and external rotation functions ( VER-brace ) and a functional knee brace used in ligament injuries ( ACL-brace ) .


Pain relief , comfort , lower extremity kinematics and kinetics during walking were compared with and without each knee brace .


Knee pain was alleviated with all three braces ( p < 0.01 ) .


The VER - and ACL-braces allowed a significant reduction in peak knee adduction moment ( KAM ) during terminal stance from 0.313 to 0.280 Nm/BwHt ( p < 0.001 ) and 0.293 to 0.268 ( p < 0.05 ) , respectively , while no significant reduction was observed with the V3P-brace ( p = 0.52 ) .


Reduced knee adduction and lower ankle and knee external rotation were observed with the V3P-brace but not with the VER-brace .


The ACL-brace did not modify lower limb kinematics .


No difference between the knee braces was found for pain reduction , discomfort or KAM .


The VER-brace was slightly more comfortable , which could ensure better compliance with treatment over the long term .


Preoperative oral carbohydrate ( CHO ) drink may improve patients ' comfort .


However , whether it prevents or reduces postoperative nausea and vomiting ( PONV ) is questionable .


Evaluate the effect of oral rehydration with 10 % CHO drink before anesthesia on incidence and severity of postoperative nausea and vomiting ( PONV ) after spinal morphine injection .


One hundred patients scheduled for unilateral total knee replacement ( TKR ) were randomly divided into two equal groups ( n = 50 each ) .


Group I patients received 400 ml 10 % CHO drink the preoperative night and 2-hour before anesthesia , whereas Group II patients served as control .


Spinal anesthesia for all patients contained 0.5 % bupivacaine 2.0 to 3.5 ml plus morphine 0.2 mg .


Pain therapy was standardized with femoral nerve block , local infiltration , intravenous parecoxib , and oral paracetamol .


Incidence and severity of PONV within 24 hours were recorded In addition , preoperative intensity of thirst and hunger , dry lips and throat , and anxiety was also recorded


Incidence and severity of PONV ( 81.2 % vs. 72.0 % , p = 0.536 ) as well as preoperative thirst , hunger dry lips , and throat were not different between the groups .


Preoperative oral rehydration with carbohydrate drinks had no positive effect on PONV nor patients ' comfort .


Vitamin D is hypothesized to have some roles in innate and adaptive immunity , inflammation reduction , and remodeling ; therefore , it is supposed to affect the asthma phenotype , severity , and response to inhaled corticosteroid ( ICS ) .


To explore the synergistic effects of vitamin D supplementation in addition to asthma controllers ( ICS or ICS plus long-acting - agonist ) on airway functions .


A randomized clinical trial was conducted in 130 individuals aged 10 to 50 years who lived in Tehran during a 24-week period .


Data on age , sex , body mass index , stage of asthma , serum total IgE , history of allergic rhinitis , atopic dermatitis , food allergy , and urticaria were collected .


Spirometric parameters ( forced expiratory volume in 1 second [ FEV1 ] and ratio of FEV1 to forced vital capacity ) and serum vitamin D measurement were obtained before and 8 and 24 weeks after the intervention .


Patients were divided in 2 groups randomly .


Both groups received asthma controllers ( budesonide or budesonide plus formoterol ) according to their stage , but the intervention group received vitamin D supplementation ( 100,000-U bolus intramuscularly plus 50,000 U orally weekly ) in addition to asthma controllers .


FEV1 improved significantly in both groups after 8 weeks , but no significant difference was found between the 2 groups at baseline ( P = .20 ) or after 8 weeks ( P = .99 ) ; however , a significant improvement was seen in the intervention group in the last 16 weeks , and FEV1 was significantly better in the intervention group than the other group after 24 weeks ( P < .001 ) .


Vitamin D supplementation associated with asthma controllers could significantly improve FEV1 in mild to moderate persistent asthma after 24 weeks .


irct.ir Identifier : IRCT201302079608N1 .


We report the first-in-human safety and immunogenicity assessment of a prototype hexon chimeric adenovirus ( Ad ) serotype 5 ( Ad5 ) vector containing the hexon hypervariable regions of Ad serotype 48 ( Ad48 ) and expressing human immunodeficiency virus ( HIV ) type 1 EnvA .


Forty-eight Ad5 and Ad48 seronegative , HIV-uninfected subjects were enrolled in a randomized , double-blind , placebo-controlled , dose escalation phase 1 study .


Four groups of 12 subjects received 10 ( 9 ) to 10 ( 11 ) viral particles ( vp ) of the Ad5HVR48.EnvA .01 vaccine ( n = 10 per group ) or placebo ( n = 2 per group ) at week 0 or weeks 0 , 4 , and 24 .


Safety and immunogenicity were assessed .


Self-limited reactogenicity was observed after the initial immunization in the highest ( 10 ( 11 ) vp ) dose group .


Responses in vaccinees included Ad48 neutralizing antibody ( nAb ) titers higher than Ad5 nAb titers , EnvA-specific enzyme-linked immunosorbent assay titers , and EnvA-specific enzyme-linked immunospot assay responses , and these responses generally persisted at week 52 .


At week 28 in the 10 ( 9 ) , 10 ( 10 ) , and 10 ( 11 ) vp 3-dose groups , geometric mean EnvA enzyme-linked immunosorbent assay titers were 5721 , 10 929 , and 3420 , respectively , and Ad48 nAb titers were a median of 1.7-fold higher than for Ad5 .


Ad5HVR48.ENVA .01 was safe , well tolerated , and immunogenic at all doses tested .


Vector-elicited nAb responses were greater for Ad48 than Ad5 , confirming that Ad-specific nAbs in humans are primarily , but not exclusively , directed against the hexon hypervariable regions .


Clinical Trials Registration.NCT00695877 .


This study compared two methods of expanding the uterine incision at the time of cesarean delivery , which is associated with the risk of unintended extension .


This randomized trial included 1,076 women who underwent elective cesarean delivery .


The primary outcome measure was the incidence of unintended extension related to the method used for expanding the uterine incision .


Participants in both groups ( blunt vs. sharp ) had similar demographic and clinical characteristics .


The incidence of unintended extension ( 8.8 % vs. 4.8 % ; p = 0.009 ) , mean estimated blood loss ( 853.67 42 mL vs. 664.80 38 mL ; p = 0.001 ) , and blood loss > 1000 mL ( 11.4 % vs. 6.8 % ; p = 0.009 ) was significantly higher in the sharp group compared with the blunt group .


No difference in transfusions ( 7.5 % vs. 6.3 % ; p = 0.440 ) or the need for additional supertonic agents ( 16 % vs. 12.9 % ; p = 0.144 ) was noted .


Sharp expansion of the uterine incision was related to a higher risk of unintended extension and maternal blood loss .


Because blunt expansion is associated with a lower risk for unintended extension and maternal blood loss , it should be the first option during elective cesarean delivery .


There is limited available information for treatment of acute coronary syndrome ( ACS ) with respect to outcomes , therapeutic agents and treatment practices .


Our retrospective registry study collected and evaluated varying anti-platelet treatment strategies and outcomes of ACS patients who were admitted to 9 different tertiary care hospitals in India .


This study was carried out to provide an insight to anti-platelet treatment patterns and analyze outcomes of ACS patients in India .


All the relevant data , including anti-platelet treatment strategies , outcomes and patient treatment compliance were collected from 500 ACS ( defined as STEMI , NSTEMI and unstable angina [ UA ] ) cases from January 2007 to December 2009 .


These ACS cases were randomly collected from the hospital records and included in the analysis .


The patient follow up data was acquired either from the hospital records or via telephonic contact for a period of one year following the event .


Out of 500 ACS patients , 59.8 % had UA/NSTEMI and 40.2 % had STEMI .


On hospital admission , aspirin , clopidogrel , statins , beta-blockers and angiotensin converting enzyme inhibitors ( ACE-Is ) were used by 83 % , 83 % , 68 % , 43.2 % and 31.6 % patients , respectively .


On discharge , aspirin , clopidogrel , statins and beta-blockers were used by 90.2 % , 88 % , 80.6 % , and 59 % patients , respectively .


The average patient compliance to statins , clopidogrel and aspirin was recorded as 74.28 % , 69.7 % and 68.66 % , respectively during discharge and follow-up visits .


Greater than 50 % of ACS patients after discharge were lost to follow-up and as a result there was significant drop in the number of clinical events reported .


This pilot study conducted in tertiary care centers in India showed that patients with ACS were more often diagnosed with UA/NSTEMI as compared to STEMI and reported maximum compliance to statins , clopidogrel and aspirin after discharge over 1 year follow-up .


More ACS patients were lost to follow up that resulted in low reporting of clinical outcomes , following discharge upto 1 year .


To our knowledge , there is no evidence to support the use of local infiltration analgesia ( LIA ) for postoperative pain relief after periacetabular osteotomy ( PAO ) .


We investigated the effect of wound infiltration with a long-acting local anesthetic ( ropivacaine ) for postoperative analgesia after PAO .


We performed a randomized , double-blind , placebo-controlled trial ( ClinicalTrials.gov : NCT00815503 ) in 53 patients undergoing PAO to evaluate the effect of local anesthetic infiltration on postoperative pain and on postoperative opioid consumption .


All subjects received intraoperative infiltration followed by 5 postoperative injections in 10-hour intervals through a multi-holed catheter placed at the surgical site .


26 patients received ropivacaine and 27 received saline .


The intervention period was 2 days and the observational period was 4 days .


All subjects received patient-controlled opioid analgesia without any restrictions on the total daily dose .


Pain was assessed at specific postoperative time points and the daily opioid usage was registered .


Infiltration with 75 mL ( 150 mg ) of ropivacaine did not reduce postoperative pain or opioid requirements during the first 4 days .


The clinical importance of ropivacaine as single component in postoperative treatment of pain is questionable , and we are planning further studies to explore the potential of LIA in larger volume-and also a multimodal regimen-to treat pain in this category of patients .


Patients with Becker muscular dystrophy ( BMD ) and Duchenne muscular dystrophy lack neuronal nitric oxide synthase ( nNOS ) .


nNOS mediates physiological sympatholysis , thus ensuring adequate blood supply to working muscle .


In mice lacking dystrophin , restoration of nNOS effects by a phosphodiesterase 5 ( PDE5 ) inhibitor ( sildenafil ) improves skeletal and cardiac muscle performance .


Sildenafil also improves blood flow in patients with BMD .


We therefore hypothesized that sildenafil would improve blood flow , maximal work capacity , and heart function in patients with BMD .


A randomized , double-blind , placebo-controlled crossover design with two 4-week periods of treatment , separated by 2-week washout was used .


We assessed brachial artery blood flow during maximal handgrip exercise , 6-minute walk test , maximal oxidative capacity , and life quality ; cardiac function was evaluated by magnetic resonance imaging ( MRI ) at rest and during maximal handgrip exercise .


Muscle nNOS and PDE5 were tested with Western blotting in 5 patients .


Sixteen patients completed all skeletal muscle evaluations , and 13 completed the cardiac MRI investigations .


Sildenafil had no effect on any of the outcome parameters .


No serious adverse effects were recorded .


PDE5 and nNOS were deficient in 5 of 5 biopsies .


Despite positive evidence from animal models of dystrophinopathy and physiological findings in patients with BMD , this double-blind , placebo-controlled clinical study showed no effect of sildenafil on blood flow , maximal work capacity , and heart function in adults with BMD .


This discrepancy may be explained by a significant downregulation of PDE5 in muscle .


Contrast-induced nephropathy ( CIN ) is an important complication in the use of iodinated contrast media .


The present study aimed to assess the safety and efficacy of prostaglandin E1 ( PGE1 ) in prevention of CIN in patients with high-risk factors undergoing percutaneous coronary intervention ( PCI ) .


The study group consisted of 163 patients who had undergone a coronary intervention procedure between January 1 , 2012 and October 31 , 2012 .


Study participants were randomly assigned to either the PGE1 group ( 82 patients ) or the control group ( 81 patients ) .


Patients in the PGE1 group received PGE1 intravenous infusion of 20 ng/kg/min for 6 h before and after the administration of contrast media .


The control group received 0.9 % sodium chloride solution for routine hydration only .


A nonionic , low-osmolality contrast agent was used in our laboratory at this time .


Serum creatinine ( Scr ) values and estimated glomerular filtration rate were measured before and within 48 h of the administration of contrast agents .


CIN was defined as an increase of 0.5 mg/dL or a 25 % increase in Scr concentrations over baseline within 48 h of angiography .


The amount of contrast agent administered was similar for the PGE1 and control groups ( 156 63 vs. 161 68 mL , P > 0.05 ) .


The incidence of CIN was lower in the PGE1 group than in the control group ( 3.7 vs. 11.1 % , P < 0.05 ) .


No serious adverse effects were observed .


In patients with high-risk factors undergoing PCI , the use of PGE1 for prevention of CIN is safe and efficacious .


To explore the efficacy and the reproductive endocrinal mechanism of herbal-partitioned moxibustion in the treatment of primary dysmenorrhea .


One hundred and seventy-one cases of primary dysmenorrhea were randomized into an herbal-partitioned moxibustion group ( group A ) , an starch-partitioned moxibustion group ( group B ) and an acupuncture group ( group C ) , 57 cases in each one .


In the group A , moxibustion isolated with herbal medicine was applied to Shenque ( CV 8 ) .


In the group B , moxibustion isolated with starch was used at Shenque ( CV 8 ) .


In the group C , acupuncture was given at Sanyinjiao ( SP 6 ) .


The changes of estradiol ( E2 ) , progesterone ( P ) and prostaglandin levels ( PGF2alpha ) were observed before and after treatment , and the therapeutic effects were compared among the 3 groups .


The therapeutic effect in the group A was better than those in the other two groups [ compared the cured rate : 89.8 % ( 44/49 ) vs 60.0 % ( 30/50 ) , 60.4 % ( 32/53 ) , both P < 0.05 ] .


In the group A , E2 level [ ( 110.99 + / - 12.90 ) pg/mL vs ( 83.94 + / - 8.91 ) pg/mL , P < 0.05 ] and PGF2alpha level [ ( 24.58 + / - 3.01 ) pg/mL vs ( 14.34 + / - 1.48 ) pg/mL , P < 0.01 ] were decreased and P level was increased [ ( 4.65 + / - 0.68 ) ng/mL vs ( 6.68 + / - 0.95 ) pg/mL , P < 0.05 ] .


In the group B and C , PGF2alpha level were reduced .


Concerning to the regulating of E2 and PGF2alpha levels , the results in the group A were better than those in the group B and C [ ( -30.16 + / - 10.20 ) pg/mL vs ( 10.79 + / - 15.01 ) pg/mL , ( 22.81 + / - 12.22 ) pg/mL ; ( -13.10 + / - 2.40 ) pg/mL vs ( -6.52 + / - 1.88 ) pg/mL , ( -3.14 + / - 1.19 ) pg/mL , ( see text ) P < 0.05 ] .


Concerning to the regulation of P level , the results in the group A and B were better than that in the group C ( all P < 0.05 ) .


The herbal-partitioned moxibustion achieves the significant efficacy on primary dysmenorrhea , which could be related to regulating the reproductive endocrinal level .


It decreases E2 and PGF2alpha levels and increases P level .


To determine if using freshest available rather than standard-issue red blood cells ( RBCs ) can reduce mortality in critically ill intensive care unit patients .


Our study is the largest ongoing randomised controlled trial ( RCT ) of RBC age in critically ill patients and will help determine if the use of the freshest available RBCs should become standard policy for the critically ill .


A double-blind , multicentre , Phase III RCT of 5000 adult ICU patients in Australia , New Zealand , Europe and the Middle East .


Transfusion of the freshest available RBCs in place of standard-care RBCs until hospital discharge .


The primary outcome measure is 90-day all-cause mortality .


Secondary outcome measures are time to death , 28-day and 180-day mortality , persistent organ dysfunction combined with death , days alive and free of mechanical ventilation and renal replacement therapy , bloodstream infection in the ICU , length of stay in the ICU and in hospital , proportion of patients with febrile non-haemolytic transfusion reactions , and quality of life at Day 180 .


A detailed statistical analysis plan with predefined subgroups and secondary analyses has been finalised before results being available , to ensure an unbiased final analysis .


The pragmatic protocol design has been chosen to facilitate translation of the trial results into practice .


The TRANSFUSE trial will have important clinical and policy implications , regardless of the outcome .


To investigate whether acute total sleep deprivation ( TSD ) leads to decreased cognitive control when food cues are presented during a task requiring active attention , by assessing the ability to cognitively inhibit prepotent responses .


Fourteen males participated in the study on two separate occasions in a randomized , crossover within-subject design : one night of TSD versus normal sleep ( 8.5 hours ) .


Following each nighttime intervention , hunger ratings and morning fasting plasma glucose concentrations were assessed before performing a go/no-go task .


Following TSD , participants made significantly more commission errors when they were presented `` no-go '' food words in the go/no-go task , as compared with their performance following sleep ( +56 % ; P < 0.05 ) .


In contrast , response time and omission errors to `` go '' non-food words did not differ between the conditions .


Self-reported hunger after TSD was increased without changes in fasting plasma glucose .


The increase in hunger did not correlate with the TSD-induced commission errors .


Our results suggest that TSD impairs cognitive control also in response to food stimuli in healthy young men .


Whether such loss of inhibition or impulsiveness is food cue-specific as seen in obesity-thus providing a mechanism through which sleep disturbances may promote obesity development-warrants further investigation .


Our objective was to demonstrate the effects of platelet-rich fibrin ( PRF ) for the healing of acute ear drum perforation .


Thirty-two patients with acute traumatic ear drum perforations were randomly separated into 2 groups .


In group 1 ( n = 14 ) , PRF was used for the repair of ear drum perforation ; in group 2 ( n = 18 ) , we did not make any intervention .


At initial inspection , perforation sizes were measured as 10.93 3.58 mm in group 1 and 10.05 4.02 mm in group 2 .


After 1 month , perforation sizes were 1.35 2.53 mm in group 1 and 4.44 3.34 mm in group 2 ( P < 0.01 ) .


In the study group , the rate of ear drum closure was 64.3 % and in the control group it was 22.2 % ( P < 0.05 ) .


Here we found that PRF is a biomaterial that quickens the healing of ear drum which is autogenous and simply prepared .


To investigate the effectiveness of educational poster on improving secondary school students ' knowledge of emergency management of dental trauma .


A cluster randomised controlled trial was conducted .


16 schools with total 671 secondary students who can read Chinese or English were randomised into intervention ( poster , 8 schools , 364 students ) and control groups ( 8 schools , 305 students ) at the school level .


Baseline knowledge of dental trauma was obtained by a questionnaire .


Poster containing information of dental trauma management was displayed in a classroom for 2 weeks in each school in the intervention group whereas in the control group there was no display of such posters .


Students of both groups completed the same questionnaire after 2 weeks .


Two-week display of posters improved the knowledge score by 1.25 ( p-value = 0.0407 ) on average .


Educational poster on dental trauma management significantly improved the level of knowledge of secondary school students in Hong Kong .


HKClinicalTrial.com HKCTR-1343 ClinicalTrials.gov NCT01809457 .


To describe the design , methods , and challenges encountered during a randomized clinical trial aimed to promote water intake for reducing risks of metabolic syndrome in Mexican women .


In a randomized clinical trial in Cuernavaca , Mexico , overweight and obese ( body mass index [ BMI ] 25 < 39 ) women , 18 - < 45 years old with an intake of sugar-sweetened beverages 250 kilocalories per day ( kcal/day ) were randomly allocated to the water and education provision group ( n = 120 ) or the education provision only group ( n = 120 ) .


We screened 1 756 women .


The main difficulties encountered were identifying participants with the recruitment criteria , delivering water to participants , and the time demanded from the study participants .


The trial 's main challenges were difficulties surrounding recruitment , delivery of the intervention , and the time demanded from the study participants .


Modifications were effectively implemented without jeopardizing the original protocol .


Early decompressive hemicraniectomy reduces mortality without increasing the risk of very severe disability among patients 60 years of age or younger with complete or subtotal space-occupying middle-cerebral-artery infarction .


Its benefit in older patients is uncertain .


We randomly assigned 112 patients 61 years of age or older ( median , 70 years ; range , 61 to 82 ) with malignant middle-cerebral-artery infarction to either conservative treatment in the intensive care unit ( the control group ) or hemicraniectomy ( the hemicraniectomy group ) ; assignments were made within 48 hours after the onset of symptoms .


The primary end point was survival without severe disability ( defined by a score of 0 to 4 on the modified Rankin scale , which ranges from 0 [ no symptoms ] to 6 [ death ] ) 6 months after randomization .


Hemicraniectomy improved the primary outcome ; the proportion of patients who survived without severe disability was 38 % in the hemicraniectomy group , as compared with 18 % in the control group ( odds ratio , 2.91 ; 95 % confidence interval , 1.06 to 7.49 ; P = 0.04 ) .


This difference resulted from lower mortality in the surgery group ( 33 % vs. 70 % ) .


No patients had a modified Rankin scale score of 0 to 2 ( survival with no disability or slight disability ) ; 7 % of patients in the surgery group and 3 % of patients in the control group had a score of 3 ( moderate disability ) ; 32 % and 15 % , respectively , had a score of 4 ( moderately severe disability [ requirement for assistance with most bodily needs ] ) ; and 28 % and 13 % , respectively , had a score of 5 ( severe disability ) .


Infections were more frequent in the hemicraniectomy group , and herniation was more frequent in the control group .


Hemicraniectomy increased survival without severe disability among patients 61 years of age or older with a malignant middle-cerebral-artery infarction .


The majority of survivors required assistance with most bodily needs .


( Funded by the Deutsche Forschungsgemeinschaft ; DESTINY II Current Controlled Trials number , ISRCTN21702227 . )


To observe the clinical efficacy of tetrandrine combined with acetylcysteine effervescent tablets in the treatment of silicosis .


A total of 96 patients with silicosis were randomly divided into treatment group ( 49 cases ) and control group ( 47 cases ) .


Both groups were given routine therapy including anti-inflammatory , antitussive , and antiasthmatic drugs , and the patients in treatment group were given tetrandrine combined with acetylcysteine effervescent tablets at the same time .


Tetrandrine ( 100 mg ) was orally administrated twice a day , and there was a one-day interval between every 6 days ' continuous administration ; totally , there were four courses of treatment , with 3 months for each course , and there was a one-month break between each course .


Acetylcysteine effervescent tablets ( 600 mg ) were taken twice a day ; each course of treatment was 12 days , and there were four courses ; for the first two months , there was one course per month , and then one course every other two months for the rest of time .


Clinical symptoms , pulmonary ventilation function , serum superoxide dismutase ( SOD ) and changes in X-ray findings were observed .


After treatment , the treatment group had significantly increased rates of improvements in cough , expectoration , chest congestion and pain , and dyspnea compared with the control group ( P < 0.05 ) .


Compared with the control group ( serum SOD level : 70.46620.261 U/ml ) and the treatment group before therapy ( serum SOD level : 68.18221.414 U/ml ) , the treatment group after therapy had significantly increased serum SOD level ( 77.38921.315 U/ml ?


, forced vital capacity , and forced expiratory volume in one second ( P < 0.05 ) .


Eight patients in treatment group showed improvement in the chest X-ray findings of silicosis .


The combination of tetrandrine and acetylcysteine effervescent tablets show some effect in the treatment of silicosis .


It can be an effective option for treating silicosis as there are no other specific remedies .


Chronic subdural hematoma ( cSDH ) is a common neurosurgical disease .


It is often considered to be a rather benign entity .


In spite of well established surgical procedures cSDH is complicated by a recurrence rate up to 30 % .


Since glucocorticoids have been used for treatment of cSDH in 1962 their role is still discussed controversially in lack of evident data .


On the basis of the ascertained inflammation cycle in cSDH dexamethasone will be an ideal substance for a short lasting , concomitant treatment protocol .


to test the efficacy of dexamethasone on reduction inthe reoperation rate of cSDH .


The study is designed as a double-blind randomized placebo-controlled trial 820 patients who are operated for cSDH and from the age of 25 years are included after obtaining informed consent .


They are randomized for administration of dexamethasone ( 16-16-12-12-8-4mg / d ) or placebo ( maltodextrin ) during the first 48 hours after surgery .


The type I error is 5 % and the type II error is 20 % .


The primary endpoint is the reoperation within 12 weeks postoperative .


This study tests whether dexamethasone administered over 6 days is a safe and potent agent in relapse prevention for evacuated cSDH .


EudraCT 201100354442 .


In this randomized , placebo-controlled clinical trial , we investigated the effect of noninvasive extracorporeal shock waves on the stability of temporary anchorage devices ( TADs ) under orthodontic loading .


Thirty adult orthodontic patients of the Bernhard Gottlieb University Clinic in Vienna , Austria , were enrolled in this clinical trial and allocated by block randomization ( size , 4 ) in a 1:1 ratio to either the treatment or the placebo group .


Randomization was performed with software , and the allocations were concealed in sealed envelopes .


Eligibility criteria included healthy adult patients with mesially directed orthodontic movement of the mandibular second molar into the extraction site of the mandibular first molar .


The fixed orthodontic devices included active superelastic coil springs ( 200cN ) and TADs in the mandibular alveolar bone .


Blinding was performed for the subjects and the outcome assessor .


The treatment group received 1 shock-wave application with 1000 impulses at 0.19 to 0.23 mJ per square millimeter in the region of the TADs .


The placebo group was treated with a deactivated shock-wave applicator and acoustic sham .


The TADs positions were evaluated at placement and after 4months .


The reliability and precision of the impression process of the TADs were evaluated in an in-vitro model .


Thirteen participants finished the investigation successfully in the treatment group but only 12 finished in the placebo group because 1 TAD loosened .


The difference of the total TAD displacement for the 4-month time period between the placebo and treatment groups was 0.170.95 mm ( 95 % CI : -0.96 , 0.62 ) .


No statistically significant difference between the 2 groups was found when sex was evaluated .


Primary stability of the TADs as measured by placement torque , amount of tooth movement , and age of the patients did not influence displacement of the TADs .


The reliability and precision of TAD impressions were confirmed .


No unintended pernicious effects occurred after shock-wave treatment during the study period .


A single application of extracorporeal shock-wave treatment did not improve the stability of the TADs during orthodontic loading .


Sufficient interradicular space should be provided to minimize the risk of periodontal and dental root defects .


This trial was registered at https://clinicaltrials.gov .


The protocol was published before trial commencement , NCT01695928 .


No funding or conflict of interest to be declared .


To investigate the reliability and agreement of measures of lower extremity muscle strength , power and functional performance in patients with hip osteoarthritis at different time intervals , and to compare these with the same measures in healthy peers .


Intra-rater test-retest separated by 1 , 2 , or 2.5 weeks in patients , and 1 week in healthy peers .


Patients with hip osteoarthritis ( age range 61-83 years ) with 1 ( n = 37 ) , 2 ( n = 35 ) , or 2.5 weeks ( n = 15 ) between tests , and 35 healthy peers ( age range 63-82 years ) .


Maximal isometric hip and thigh strength , leg extensor power , and functional performance ( 8-foot Up & Go , stair climbing , chair stand and 6-min walk ) were measured in patients , and quadriceps strength , leg extensor power and functional performance were measured in healthy peers .


Systematic error , reliability and agreement were calculated .


Most hip strength measurements for the most symptomatic extremity , and nearly all strength measurements for the least symptomatic lower extremity , declined after 1 week ( p < 0.05 ) , but not after a 2.5-week interval .


In healthy peers , quadriceps strength was unchanged .


Regardless of the time interval , leg extensor power was unchanged , while functional performances improved at retest for all participants .


In patients with hip osteoarthritis leg extensor power is unaffected by the time interval between tests , in contrast to muscle strength and functional performance .


To observe the efficacy and the influence on quality of life ( QOL ) of syndrome differentiation treatment with Chinese medicine ( CM ) for opioid-induced constipation as well as the safety and influence on analgesic effect of opioids .


Totally 406 cases enrolled from 53 collaborating medical centers were randomly assigned to a CM group and a control group .


The CM group were treated with CM decoction based on syndrome differentiation , and the control group were treated with Phenolphthalein Tablet .


Both groups were treated for 14 days .


Cleveland constipation score ( CCS ) , numerical rating scale ( NRS ) of pain and Chinese version of European Organisation for Research and Treatment of Cancer , Quality of Life Questionnaire-C30 V3 .0 ( EORTC QLQ-C30 V3 .0 ) were used to evaluate the efficacy , pain controlled and QOL status .


The comparisons of CCS score reduction and QOL between the two groups after treatment suggested that the improvements of constipation and QOL in the CM group were better than that in the control group ( P < 0.05 ) .


The total efficiency of the CM group was better than the control group ( 93.5 % vs. 86.4 % , P < 0.05 ) .


There was no significant difference in NRS scores between before and after treatment in both groups .


There was no serious drug-related adverse event during the course of study .


CM decoction could effectively treat opioid-induced constipation and improve patients ' QOL at the same time .


It is safe and does n't affect the analgesic effect of opioids when treating constipation .


To compare safety and efficacy of pantoprazol , metoclopramide , ondansetron , as compared to placebo , in controlling gastrointestinal ( GI ) complaints of thyroid cancer patients treated with I-131these patients .


Four-armed , parallel group , single blind , randomized controlled clinical trial , setting : A university hospital , registration : database for clinical trials IRCT2013061713705N1 .


85 patients with differentiated thyroid cancer who received 131I .


Postradioiodine nausea and vomiting within three days of therapy ( primary endpoint ) ; occurrence of adverse reaction .


The patients ' characteristics were similar within the study groups .


Among the study variables , age , sex , administered dosage , history of previous GI complaints , and history of hyperemesis gravidarum in female patients were not statistically different among the groups ( p > 0.05 ) .


The results revealed that only ondansetron shows a therapeutic benefit over the placebo in controlling nausea ( p < 0.05 ) ; however , it does not prevent vomiting ( p > 0.05 ) .


The other two drugs , pantoprazole and metoclopramide , did not control nausea ( p > 0.05 ) or vomiting ( p > 0.05 ) .


This study may demonstrate that the therapeutic dose of ondansetron could be an effective prophylactic agent in controlling GI complaints in differential thyroid carcinoma ( DTC ) patients following RAI therapy ; however , these preliminary findings should be validated in larger studies .


To conduct a process and impact evaluation of a multifaceted education-based pilot program targeting correct use of age-appropriate restraints in a regional setting with a high proportion of Aboriginal and Torres Strait Islander families .


The program was delivered in 2010 in 3 early learning centers where 31 percent of the children were of Aboriginal and Torres Strait Islander descent .


Each component of the program was assessed for message consistency and uptake .


To measure program effectiveness , participating children were matched 1:1 by age , language spoken at home , and annual household income with 71 children from the control arm of a contemporaneous trial .


The outcome measure in the control and program centers ( a 4-category ordinal scale of restraint use ) was compared using ordinal logistic regression accounting for age of the parent .


Process evaluation found that though program components were delivered with a consistency of message , uptake was affected by turnover of all staff at one center and by parents experiencing difficulty in paying for subsidized restraints at each of the centers .


Impact evaluation found that children from the centers receiving the program had nearly twice the odds of being in a better restraint category than children matched from the control group ( adjusted odds ratio [ ORadj ] = 2.06 , 95 % confidence interval [ CI ] , 1.09-3 .90 ) .


This was a pragmatic study reflecting the real-life issues of implementing a program in preschools where 57 percent of families had a low income and turnover of staff was high .


Despite these issues , impact evaluation showed that the integrated educational program showed promise in increasing correct use of age-appropriate restraints .


The findings from this pilot study support the use of an integrated educational program that includes access to subsidized restraints to promote best practice child restraint use among communities that include a high proportion of Aboriginal and Torres Strait Islander families in New South Wales .


Future trials in similar settings should consider offering more support in centers with high turnover of staff and offering alternative methods of payment when families experience financial difficulties in purchasing the subsidized restraints .


If proven in larger trials , this approach could reduce death and injuries in child passengers in this vulnerable group .


To evaluate the anginal attack-relieving efficacy and safety of Kuanxiong Aerosol ( KA ) in patients with coronary heart disease ( CHD ) .


A total of 780 patients confirmatively diagnosed as CHD angina from November 2011 to December 2012 in 13 medical centers in the mainland area were assigned to 2 groups by blocked randomization , the treatment group ( 376 cases ) and the control group ( 374 cases ) .


When the angina attacked , patients in the treatment group received sublingual spray three times , 0.6 mL each time , while those in the control group sublingually dissolved Nitroglycerin Tablet ( NT ) , 0.5 mg each tablet .


The effective rate of angina relief , efficacy of electrocardiogram ( ECG ) , and the incidence of adverse reactions were observed .


The 3 min and 5 min remission rates of angina attack were 53.72 % ( 202/376 ) and 94.41 % ( 355/376 ) in the treatment group , and 47.86 % ( 179/374 ) and 90.64 % ( 339/374 ) in the control group .


The 95 % confidence interval ( CI ) of the difference between the 2 groups of 3 min and 5 min remission rates of angina attacks were [ ( -1.84 % , 12.32 % ) and ( -1.33 % , 6.85 % ) respectively , P > 0.05 ] .


The total improvement rates of ST-T changes in the treatment group and the control group after treatment were 74.07 % and 73.13 % respectively ( P > 0.05 ) .


The adverse reaction rate was 9.31 ( 35/376 cases ) in the treatment group and 22.46 % ( 84/374 cases ) in the control group ( P < 0.01 ) .


KA was not inferior to NT in relieving anginal attacks and improving ischemic ECG changes , and had obviously less adverse reaction .


Research directed to optimizing maternal nutrition commencing prior to conception remains very limited , despite suggestive evidence of its importance in addition to ensuring an optimal nutrition environment in the periconceptional period and throughout the first trimester of pregnancy .


This is an individually randomized controlled trial of the impact on birth length ( primary outcome ) of the time at which a maternal nutrition intervention is commenced : Arm 1 : 3 mo preconception vs. Arm 2 : 12-14 wk gestation vs. Arm 3 : none .192 ( derived from 480 ) randomized mothers and living offspring in each arm in each of four research sites ( Guatemala , India , Pakistan , Democratic Republic of the Congo ) .


The intervention is a daily 20 g lipid-based ( 118 kcal ) multi-micronutient ( MMN ) supplement .


Women randomized to receive this intervention with body mass index ( BMI ) < 20 or whose gestational weight gain is low will receive an additional 300 kcal/d as a balanced energy-protein supplement .


Researchers will visit homes biweekly to deliver intervention and monitor compliance , pregnancy status and morbidity ; ensure prenatal and delivery care ; and promote breast feeding .


The primary outcome is birth length .


Secondary outcomes include : fetal length at 12 and 34 wk ; incidence of low birth weight ( LBW ) ; neonatal/infant anthropometry 0-6 mo of age ; infectious disease morbidity ; maternal , fetal , newborn , and infant epigenetics ; maternal and infant nutritional status ; maternal and infant microbiome ; gut inflammatory biomarkers and bioactive and nutritive compounds in breast milk .


The primary analysis will compare birth Length-for-Age Z-score ( LAZ ) among trial arms ( independently for each site , estimated effect size : 0.35 ) .


Additional statistical analyses will examine the secondary outcomes and a pooled analysis of data from all sites .


Positive results of this trial will support a paradigm shift in attention to nutrition of all females of child-bearing age .


ClinicalTrials.gov NCT01883193 .


The objective of the study was to evaluate objective and subjective outcomes of MiniArc and Monarc ( American Medical Systems , Minnetonka , MN ) midurethral sling ( MUS ) in women with stress incontinence at 12 months .


A total of 225 women were randomized to receive MiniArc or Monarc .


Women with intrinsic sphincter deficiency , previous MUS , or untreated detrusor overactivity were excluded .


Objective cure was defined as negative cough stress test with a comfortably full bladder .


Subjective cure was defined as no report of leakage with coughing or exercise on questionnaire .


Validated questionnaires , together with urodynamic and clinical cough stress test , were used to evaluate the objective and subjective outcomes following surgery .


Participants and clinicians were not masked to treatment allocation .


Outcomes were compared with exact binomial tests ( eg , Fisher exact test for dichotomous data ) for categorical data and Student t tests or exact versions of Wilcoxon tests for numerical data as appropriate .


There was no statistically significant difference in the subjective ( 92.2 % vs 94.2 % ; P = .78 ; difference , 2.0 % ; 95 % confidence interval , -2.7 % to +6.7 % ) or objective ( 94.4 % vs 96.7 % ; P = .50 ; difference , 2.3 % ; 95 % confidence interval , -1.5 % to +6.1 % ) cure rates between MiniArc and Monarc at 12 m , respectively , with a significant improvement in overactive bladder outcomes and incontinence impact from baseline in both arms .


MiniArc outcomes are not inferior to Monarc MUS outcomes at 12 months ' follow-up in women without intrinsic sphincter deficiency .


Examine the efficacy of a parent-augmented One-Session Treatment ( A-OST ) in treating specific phobias ( SP ) in youth by comparing this novel treatment to child-focused OST , a well-established treatment .


A total of 97 youth ( ages 6-15 , 51.5 % female , 84.5 % White ) who fulfilled diagnostic criteria for SP were randomized to either A-OST or OST .


SPs were assessed with semistructured diagnostic interviews , clinician improvement ratings , and parent and child improvement ratings .


In addition , measures of treatment satisfaction and parental self-efficacy were obtained .


Blind assessments were completed pretreatment , posttreatment , and 1month and 6months following treatment .


Analyses were undertaken using mixed models .


In addition , gender , age , internalizing/externalizing problems , parent overprotection , and parent anxiety were examined as potential predictors and moderators of treatment outcome .


Both treatment conditions produced similar outcomes with approximately 50 % of youth in both treatments diagnosis free and judged to be much or very much improved at posttreatment and 1-month follow-up .


At 6-month follow-up , however , the treatments diverged with OST resulting in marginally superior outcomes to A-OST , contrary to predictions .


Only age of child predicted treatment outcome across the two treatments ( older children did better ) ; unexpectedly , none of the variables moderated treatment outcomes .


Parent augmentation of OST produced no appreciable gains in treatment outcomes .


Directions for future research are highlighted .


In northern Vietnam the Neonatal health - Knowledge Into Practice ( NeoKIP , Current Controlled Trials ISRCTN44599712 ) trial has evaluated facilitation as a knowledge translation intervention to improve neonatal survival .


The results demonstrated that intervention sites , each having an assigned group including local stakeholders supported by a facilitator , lowered the neonatal mortality rate by 50 % during the last intervention year compared with control sites .


This process evaluation was conducted to identify and describe mechanisms of the NeoKIP intervention based on experiences of facilitators and intervention group members .


Four focus group discussions ( FGDs ) were conducted with all facilitators at different occasions and 12 FGDs with 6 intervention groups at 2 occasions .


Fifteen FGDs were audio recorded , transcribed verbatim , translated into English , and analysed using thematic analysis .


Four themes and 17 sub-themes emerged from the 3 FGDs with facilitators , and 5 themes and 18 sub-themes were identified from the 12 FGDs with the intervention groups mirroring the process of , and the barriers to , the intervention .


Facilitators and intervention group members concurred that having groups representing various organisations was beneficial .


Facilitators were considered important in assembling the groups .


The facilitators functioned best if coming from the same geographical area as the groups and if they were able to come to terms with the chair of the groups .


However , the facilitators ' lack of health knowledge was regarded as a deficit for assisting the groups ' assignments .


FGD participants experienced the NeoKIP intervention to have impact on the knowledge and behaviour of both intervention group members and the general public , however , they found that the intervention was a slow and time-consuming process .


Perceived facilitation barriers were lack of money , inadequate support , and the function of the intervention groups .


This qualitative process evaluation contributes to explain the improved neonatal survival and why this occurred after a latent period in the NeoKIP project .


The used knowledge translation intervention , where facilitators supported multi-stakeholder coalitions with the mandate to impact upon attitudes and behaviour in the communes , has low costs and potential for being scaled-up within existing healthcare systems .


To compare normal saline ( NS ) vs. NS + budesonide irrigations in post - functional endoscopic sinus surgery ( FESS ) patients with chronic rhinosinusitis with polyposis ( CRSwNP ) .


Currently , no evidence exists for NS + budesonide irrigation over NS irrigation alone .


Prospective , single-blind , randomized controlled trial .


Subjects were prospectively enrolled to NS or NS + budesonide arms .


Patients were evaluated at pre-operative and three post-operative visits ( POV ) : POV1 ( 1-2 weeks post-op ) , POV2 ( 3-8 weeks post-op ) , and POV3 ( 3-6 months post-op ) .


Patients were evaluated by three quality of life ( QOL ) questionnaires ( SNOT-22 , RSOM-31 , and RSDI ) and two olfaction scores ( UPSIT and the PEA test ) .


Fifty patients were randomized , with 25 patients in the NS arm and 25 patients in the NS + budesonide arm .


Two patients had unexpected pathology and were excluded from the study .


By POV2 and POV3 , patients experienced a significant improvement in all three QOL surveys , although the degree of improvement between arms was not significant up through POV3 .


Neither arm experienced significant olfactory improvement up through POV3 .


While both NS and NS + budesonide treatments improve QOL for post-FESS patients , neither intervention significantly increases QOL as compared to the other .


Olfaction was not significantly improved in either treatment group .


The aim of this study was to evaluate the effectiveness of Quetiapine versus Risperidone in control of acute psychotic signs and symptoms in hospitalized patients during four weeks .


In this double-blind , randomized controlled study , a total of 90 patients with a confirmed diagnosis acute psychosis and were hospitalized in Zare Hospital , Sari , Iran , and they were treated with Quetiapine ( mean 500 mg/day ) or Risperidone ( mean 5.2 mg/day ) , in a 4 week period .


The positive and negative symptoms scale ( PANSS ) and Clinical Global Impression-Severity scale ( CGI-s ) were used to assess psychotic symptoms and severity of illness in first and the last day of the study .


No significant difference found between two groups in decreasing positive and negative sub-scores in the PANSS .


Risperidone was superior to Quetiapine in decreasing the PANSS general psychopathology sub-scores and total score ( p < 0.05 ) .


No significant difference found between two groups in decreasing CGI-s score .


This study aimed to investigate the feasibility and effects of intramuscular injections of autologous bone marrow cells ( BMC ) combined with off-pump coronary artery bypass grafts ( OPCAB ) on improving cardiac function in chronic myocardial infarction patients .


Ninety patients with chronic myocardial infarction were prospectively enrolled and randomized to an OPCAB with saline or an OPCAB with BMC-treatment group .


After finishing CABG , patients received injections of BMC or saline into the marginal area of the infarct .


The primary endpoint was incidence of emergent adverse events within 6 months .


There were no differences between the control and BMC-treated groups in baseline ejection fractions ( EF ) or wall motion score indices ( WMSI ) in the affected segments .


At the 6-month follow-up , the ejection fraction was significantly increased in the BMC-treated group compared to controls ( 47.58 6.34 vs. 40.11 7.42 ; p < 0.05 ) , whereas the WMSI were significantly decreased ( 1.25 0.32 vs. 1.54 0.53 ; p < 0.05 ) , with no occurrences of life-threatening arrhythmias or death .


The addition of BMC injections to OPCAB treatment increased regional perfusion to the marginal infarct area .


These results demonstrate that BMC transplant is beneficial to the cardiac function with no adverse effects , and therefore a safe and feasible adjunct therapy providing beneficial effects in clinical practice .


To evaluate the influence of topographic profiles ( i.e. , inner directional angle and angular width ) of localized retinal nerve fiber layer ( RNFL ) defects on the diagnostic performance of macular ganglion cell-inner plexiform layer ( GCIPL ) thickness in discriminating preperimetric glaucoma ( PPG ) eyes from normal control eyes .


The ganglion cell analysis algorithm in Cirrus OCT was performed to determine the macular GCIPL thickness .


Areas under the receiver operating characteristic curves ( AUROCs ) and the sensitivities/specificities based on an internal normative database were evaluated .


The effect of the inner directional angle and the angular width of localized RNFL defects on the diagnostic performance of macular GCIPL parameters were evaluated by using linear-by-linear association analysis and logistic regression analysis .


Ninety-two patients with PPG and 92 age-matched healthy control subjects were enrolled in this study .


The AUROC of the best parameters in macular GCIPL was 0.823 ( inferotemporal sector ) , which showed no significant difference in comparison to the best parameters of peripapillary RNFL ( 7 o'clock sector , 0.764 ) and optic nerve head ( rim area , 0.767 ) ( for all comparisons , P > 0.05 ) .


A significant linear association was observed between the inner directional angle of RNFL defects and the sensitivity of macular GCIPL parameters for detecting RNFL defects .


The angular width of RNFL defects was not significantly associated with the sensitivity of macular GCIPL parameters .


The diagnostic ability of macular GCIPL parameters was comparable to that of peripapillary RNFL and ONH parameters in PPG .


The inner directional angle of RNFL defects , but not the angular width , affects the diagnostic sensitivity of macular GCIPL parameters .


To evaluate the effectiveness of group education , led by health promoters using a guiding style , for people with type 2 diabetes in public sector community health centres in Cape Town .


This was a pragmatic clustered randomized controlled trial with 17 randomly selected intervention and 17 control sites .


A total of 860 patients with type 2 diabetes , regardless of therapy used , were recruited from the control sites and 710 were recruited from the intervention sites .


The control sites offered usual care , while the intervention sites offered a total of four monthly sessions of group diabetes education led by a health promoter .


Participants were measured at baseline and 12 months later .


Primary outcomes were diabetes self-care activities , 5 % weight loss and a 1 % reduction in HbA ( 1c ) levels .


Secondary outcomes were self-efficacy , locus of control , mean blood pressure , mean weight loss , mean waist circumference , mean HbA1c and mean total cholesterol levels and quality of life .


A total of 422 ( 59.4 % ) participants in the intervention group did not attend any education sessions .


No significant improvement was found in any of the primary or secondary outcomes , apart from a significant reduction in mean systolic ( -4.65 mmHg , 95 % CI 9.18 to -0.12 ; P = 0.04 ) and diastolic blood pressure ( -3.30 mmHg , 95 % CI -5.35 to -1.26 ; P = 0.002 ) .


Process evaluation suggested that there were problems with finding suitable space for group education in these under-resourced settings , with patient attendance and with full adoption of a guiding style by the health promoters .


The reported effectiveness of group diabetes education offered by more highly trained professionals , in well-resourced settings , was not replicated in the present study , although the reduction in participants ' mean blood pressure is likely to be of clinical significance .


In the EXIST-1 trial , initiated on Aug 10 , 2009 , more than 35 % of patients with subependymal giant cell astrocytoma ( SEGA ) associated with tuberous sclerosis complex had at least 50 % reduction in SEGA volume after 96 months of treatment with everolimus .


In this Article , we report interim data ( up to Jan 11 , 2013 ) to support longer-term tolerability and efficacy of everolimus from the continuing 4-year extension phase of EXIST-1 .


We assessed data from a prospective , open-label extension of a multicentre , phase 3 , randomised , double-blind , placebo-controlled study in patients with tuberous sclerosis complex who had SEGA that was growing and needed treatment .


In this extension study , we included all patients who had been assigned everolimus during the double-blind , randomised phase of the trial and those patients who crossed over from the placebo group to receive everolimus during the randomised phase or at the start of the extension phase .


All patients received oral everolimus at a starting dose of 45 mg/m ( 2 ) per day .


Everolimus dose was subsequently adjusted subject to tolerability to attain blood trough concentrations of 5-15 ng/mL .


An independent central radiology review team assessed SEGA response ( at least a 50 % reduction from baseline in total volume of all target SEGAs ; the primary endpoint ) by MRI at 12 , 24 , and 48 weeks , then every year thereafter in all patients who received at least one dose of everolimus .


This study was registered with ClinicalTrials.gov , number NCT00789828 .


Of the original 117 randomly assigned patients , 111 were given everolimus between Aug 20 , 2009 , and Jan 11 , 2013 ( date of data cutoff ) ; we included these patients in our longer-term analysis .


Median duration of everolimus exposure was 293 months ( IQR 194-338 ) .


Median follow-up was 283 months ( IQR 193-330 ) .


54 ( 49 % ) patients had a response of 50 % or greater reduction in SEGA volume ( 95 % CI 390-583 ) , and duration of response was between 21 and 311 months ( median not reached ) .


SEGA volume was reduced by 50 % or more in 39 ( 37 % ) of 105 patients at 24 weeks , 48 ( 46 % ) of 104 patients at 48 weeks , 36 ( 47 % ) of 76 patients at 96 weeks , and 11 ( 38 % ) of 29 patients at 144 weeks .


Stomatitis ( 48 [ 43 % ] patients ) and mouth ulceration ( 33 [ 30 % ] patients ) were the most frequent treatment-related adverse events ; infections were the most commonly reported treatment-related serious adverse event , occurring in 15 ( 14 % ) patients .


35 ( 32 % ) patients reported treatment-related grade 3 or 4 adverse events , the most common of which were stomatitis ( nine [ 8 % ] ) and pneumonia ( nine [ 8 % ] ) .


18 ( 16 % ) patients had treatment-related serious adverse events .


Six ( 5 % ) patients withdrew because of adverse events .


These results support the longer-term use of everolimus in patients who have few treatment options and who need continued treatment for tuberous sclerosis complex and its varied manifestations .


Reduction or stabilisation of tumour volume with everolimus will hopefully provide long-term clinical benefit in patients with SEGA .


Novartis Pharmaceuticals .


Noncontrast computed tomography ( NCCT ) has high sensitivity , specificity , and is able to predict stone composition using Hounsfield units ( HU ) but is associated with high radiation exposure .


In an attempt to reduce radiation exposure , low-dose stone protocols have been developed that provide excellent detection of stones .


It is not known , however , whether these protocols are equally effective in determining HU stone density .


The purpose of this study is to compare stone HU attenuation between low - and conventional-dose NCCT .


In this prospective randomized , single blinded study , 7-mm calcium oxalate stones were placed randomly into nine intact urinary systems and scanned in three different cadaveric vehicles .


Holding other parameters constant , NCCT was performed at varying mAs levels ranging from 5 to 140 .


Identical magnified images at each mAs setting were reviewed in a blinded fashion to determine HU attenuation .


Statistical analyses were performed using a Kruskal-Wallis test and the Levene test , with P < 0.05 considered significant .


In 19 different stone configurations with 133 stones , median attenuation levels were 614 , 674 , 681 , 669 , 670 , 674 , and 667 HU at 5 , 7.5 , 15 , 30 , 50 , 70 , and 140 mAs , respectively .


The differences in median attenuation levels were not significantly different ( P = 0.998 ) .


An increasing trend of attenuation variability was noticed as the radiation dose decreased ; however , this was not significant ( P = 1.0 ) .


Low-dose NCCT results in similar HU attenuation compared with conventional-dose NCCT .


Although there is a slight increase in variability , low-dose NCCT provides similar information to assist in determining stone composition as conventional-dose NCCT .


Rapid eye movement ( REM ) sleep is considered critical to the consolidation of procedural memory - the memory of skills and habits .


Many antidepressants strongly suppress REM sleep , however , and procedural memory consolidation has been shown to be impaired in depressed patients on antidepressant therapy .


As a result , it is important to determine whether antidepressive therapy can lead to amnestic impairment .


We thus investigated the effects of the anticholinergic antidepressant amitriptyline on sleep-dependent memory consolidation .


Double-blind , placebo-controlled , randomized , parallel-group study .


Sleep laboratory .


Twenty-five healthy men ( mean age : 26.8 5.6 y ) .


75 mg amitriptyline versus placebo .


To test memory consolidation , a visual discrimination task , a finger-tapping task , the Rey-Osterrieth Complex Figure Test , and the Rey Auditory-Verbal Learning Test were performed .


Sleep was measured using polysomnography .


Our findings show that amitriptyline profoundly suppressed REM sleep and impaired perceptual skill learning , but not motor skill or declarative learning .


Our study is the first to demonstrate that an antidepressant can affect procedural memory consolidation in healthy subjects .


Moreover , considering the results of a recent study , in which selective serotonin reuptake inhibitors and serotonin-norepinephrine reuptake inhibitors were shown not to impair procedural memory consolidation , our findings suggest that procedural memory consolidation is not facilitated by the characteristics of REM sleep captured by visual sleep scoring , but rather by the high cholinergic tone associated with REM sleep .


Our study contributes to the understanding of potentially undesirable behavioral effects of amitriptyline .


Risk factors for first stroke are well established , but less is known about risk factors for recurrent stroke .


In the present analysis , we aimed to assess the effect of heart rate and other possible predictors of stroke in a hypertensive population with previous stroke or transient ischemic attack ( TIA ) .


The Valsartan Antihypertensive Long-Term Use Evaluation trial was a multicentre , double-masked , randomized controlled , parallel group trial comparing the effects of an angiotensin receptor blocker ( valsartan ) and a calcium channel blocker ( amlodipine ) in patients with hypertension and high cardiovascular risk .


We used Cox proportional hazard models to investigate the effect of baseline variables on the risk of stroke .


Quadratic terms of the continuous variables were entered in the models to test for linearity .


Of 15,245 patients included in the trial , 3014 had a previous stroke or TIA at baseline and were included in the present analysis .


Stroke recurrence occurred in 239 patients ( 7.9 % ) during a median of 4.5 years of follow-up .


Resting heart rate ( per 10 beats per minute ; hazard ratio [ HR ] , 2.78 ; 95 % confidence interval [ CI ] , 1.18-6 .58 ) and diabetes mellitus at baseline ( HR , 1.47 ; 95 % CI , 1.03-2 .10 ) were significantly associated with an increased risk of stroke recurrence in the multivariable analysis .


In high-risk , hypertensive patients with previous stroke or TIA , resting heart rate was the strongest predictor of recurrent stroke .


Arthrocentesis ( AC ) is an acceptable treatment modality in the treatment of internal derangement ( ID ) pain .


This study evaluated outcomes of AC on pain relief of ID pain with or without corticosteroids .


This single-blind clinical trial was conducted on 60 patients with ID pain who were randomly assigned to 2 groups ( 30 in each group ) for AC .


The AC of the upper joint space was then performed by using Ringer lactate under local anesthesia in both groups .


In the second group , the procedure was followed by the administration of a single-dose intra-articular dexamethasone ( 8 mg ) .


Assessments were made at baseline ( T0 ) , 1 month ( T1 ) , and 6 months ( T6 ) after AC ; pain , maximum mouth opening , and joint sounds before and after treatment up to 6 months were evaluated .


Pain severity was documented according to Visual Analogue Scale .


Age , sex , and skeletal maxillomandibular relationship were considered as variable factors , and irrigation with or without corticosteroids was a predictive factor of the study .


Pain , click , and maximum mouth opening were other assessment outcomes of the study .


Comparison of age , sex , and skeletal relationship did not show any significant differences between the 2 groups .


Results did not demonstrate any difference for click between the 2 groups .


Comparison of pain severity in T0 , T1 , and T2 between the 2 groups did not show any significant differences ( P < 0.05 ) .


The repeat measure test revealed a significant change in T0 , T1 , and T2 for both groups ( P < 0.001 ) .


MMO significantly changed between T0 and T1 and T0 and T6 in the 2 groups without any significant differences between them .


The AC is an effective procedure for a short-term reduction of pain in temporomandibular disorder cases .


It seems that AC using Ringer solution with or without corticosteroids may have the same effect on pain relief .


Cytogenetically normal ( CN ) acute myeloid leukemia ( AML ) is the largest and most heterogeneous cytogenetic AML subgroup .


For the practicing clinician , it is difficult to summarize the prognostic information of the growing number of clinical and molecular markers .


Our purpose was to develop a widely applicable prognostic model by combining well-established pretreatment patient and disease characteristics .


Two prognostic indices for CN-AML ( PINA ) , one regarding overall survival ( OS ; PINAOS ) and the other regarding relapse-free survival ( RFS ; PINARFS ) , were derived from data of 572 patients with CN-AML treated within the AML Cooperative Group 99 study ( www.aml-score.org ) .


On the basis of age ( median , 60 years ; range , 17 to 85 years ) , performance status , WBC count , and mutation status of NPM1 , CEBPA , and FLT3-internal tandem duplication , patients were classified into the following three risk groups according to PINAOS and PINARFS : 29 % of all patients and 32 % of 381 responding patients had low-risk disease ( 5-year OS , 74 % ; 5-year RFS , 55 % ) ; 56 % of all patients and 39 % of responding patients had intermediate-risk disease ( 5-year OS , 28 % ; 5-year RFS , 27 % ) , and 15 % of all patients and 29 % of responding patients had high-risk disease ( 5-year OS , 3 % ; 5-year RFS , 5 % ) , respectively .


PINAOS and PINARFS stratified outcome within European LeukemiaNet genetic groups .


Both indices were confirmed on independent data from Cancer and Leukemia Group B/Alliance trials .


We have developed and validated , to our knowledge , the first prognostic indices specifically designed for adult patients of all ages with CN-AML that combine well-established molecular and clinical variables and that are easily applicable in routine clinical care .


The integration of both clinical and molecular markers could provide a basis for individualized patient care through risk-adapted therapy of CN-AML .


Postoperative apnea is a complication in young infants .


Awake regional anesthesia ( RA ) may reduce the risk ; however , the evidence is weak .


The General Anesthesia compared to Spinal anesthesia study is a randomized , controlled trial designed to assess the influence of general anesthesia ( GA ) on neurodevelopment .


A secondary aim is to compare rates of apnea after anesthesia .


Infants aged 60 weeks or younger , postmenstrual age scheduled for inguinal herniorrhaphy , were randomized to RA or GA. .


Exclusion criteria included risk factors for adverse neurodevelopmental outcome and infants born less than 26 weeks gestation .


The primary outcome of this analysis was any observed apnea up to 12 h postoperatively .


Apnea assessment was unblinded .


Three hundred sixty-three patients were assigned to RA and 359 to GA. .


Overall , the incidence of apnea ( 0 to 12 h ) was similar between arms ( 3 % in RA and 4 % in GA arms ; odds ratio [ OR ] , 0.63 ; 95 % CI , 0.31 to 1.30 , P = 0.2133 ) ; however , the incidence of early apnea ( 0 to 30 min ) was lower in the RA arm ( 1 vs. 3 % ; OR , 0.20 ; 95 % CI , 0.05 to 0.91 ; P = 0.0367 ) .


The incidence of late apnea ( 30 min to 12 h ) was 2 % in both RA and GA arms ( OR , 1.17 ; 95 % CI , 0.41 to 3.33 ; P = 0.7688 ) .


The strongest predictor of apnea was prematurity ( OR , 21.87 ; 95 % CI , 4.38 to 109.24 ) , and 96 % of infants with apnea were premature .


RA in infants undergoing inguinal herniorrhaphy reduces apnea in the early postoperative period .


Cardiorespiratory monitoring should be used for all ex-premature infants .


This randomized clinical trial compared endovenous laser ablation ( EVLA ) and surgical ligation with attempted stripping in the treatment of small saphenous vein ( SSV ) insufficiency .


The early results demonstrated that EVLA was more likely to eradicate axial reflux and was also associated with a faster recovery , lower periprocedural pain , and fewer sensory complications .


The aim of this 2-year follow-up was to establish whether these benefits remained stable over time and whether these improved technical outcomes were associated with less clinical recurrence .


Patients with primary saphenopopliteal junction and SSV reflux were randomized to EVLA or saphenopopliteal junction ligation and attempted stripping/excision .


Outcomes assessed at 2 years included the presence of residual or recurrent reflux , clinical recurrence , sensory complications , the need for secondary intervention , and patient-reported quality of life on the Aberdeen Varicose Veins Questionnaire , SF-36 , and EuroQol .


Of 106 patients who were equally randomized and successfully treated according to the protocol , 88 ( 83 % ) were successfully assessed at 2 years .


The groups were comparable at baseline .


At 2 years , EVLA remained superior to surgery in eradicating axial reflux in 36 patients ( 81.2 % ) compared with 29 ( 65.9 % ) in the surgery group ( P = .002 ) .


There was no significant difference in clinical recurrence ( EVLA : seven of 44 [ 16 % ] vs surgery : 10 of 44 [ 23 % ] ; P = .736 ) , sensory disturbance ( EVLA : one [ 2.4 % ] vs surgery vs three [ 6.8 % ] ; P = 1.000 ) or any quality of life domain .


The results of treatment of SSV insufficiency with EVLA appear durable up until 2 years .


The study does not appear to suggest that the improved abolition of reflux after EVLA compared with surgery is associated with superior outcomes than those seen after surgery by this time point , because equal effect was shown in both groups .


The sensory disturbance associated with surgery appears to settle over this time frame .


EVLA is therefore superior in the short-term and not inferior by 2 years .


Neutralizing antibodies in breast milk may adversely influence the immune response to live oral vaccines .


Withholding breastfeeding around the time of vaccine administration has been suggested for improving vaccine performance .


However , we do not know whether mothers find withholding breastfeeding around the time of vaccination acceptable and how they perceive this recommendation .


In a clinical study designed to examine predictors of poor immune response to rotavirus vaccine in infants in India , Rotarix was administered to infants at 6 and 10 weeks with other childhood vaccines .


For the study , 400 mother-infant pairs were randomized into two groups in a 1:1 ratio .


Mothers were either recommended to withhold breastfeeding or were encouraged to breastfeed half an hour before and after administration of Rotarix .


The mother-infant pairs were observed and the breastfeeding intervals were recorded during this period .


Mothers were administered a questionnaire about their perception of the intervention after the infants received the second dose of Rotarix .


Almost 98 % ( 391/400 ) of the infants received both doses of Rotarix .


Adherence to the recommendations was high in both groups .


All mothers in the group who were asked to withhold breastfeeding did so , except one who breastfed her infant before the recommended time after the first dose of Rotarix .


Of the mothers , 4 % ( 7/195 ) reported that the recommendation to withhold breastfeeding was difficult to follow .


All mothers in this group reported that they would withhold breastfeeding at the time of vaccination if they were asked to by a health-care provider .


Only one mother responded that withholding breastfeeding would be a reason for not giving rotavirus vaccine to her infant .


Withholding breastfeeding half an hour before and after vaccination appears to be acceptable to mothers in this setting .


If withholding breastfeeding produces an improvement in the performance of the vaccine , it could be used to increase the public health impact of rotavirus immunization .


Clinical Trial Registry , India ( CTRI/2012/10 / 003057 ) , Clinicaltrials.gov ( NCT01700127 ) .


Date of Registration : Clinical Trial Registry , India : 28 September 2012 , Clinicaltrials.gov : 3 October 2012 .


The aim of the study was to determine whether individualized coaching improved surgical technical skill in the operating room to a higher degree than current residency training .


Clinical training in the operating room is a valuable opportunity for surgeons to acquire skill and knowledge ; however , it often remains underutilized .


Coaching has been successfully used in various industries to enhance performance , but its role in surgery has been insufficiently investigated .


This randomized controlled trial was conducted at one surgical training program .


Trainees undergoing a minimally invasive surgery rotation were randomized to either conventional training ( CT ) or comprehensive surgical coaching ( CSC ) .


CT included ward and operating room duties , and regular departmental teaching sessions .


CSC comprised performance analysis , debriefing , feedback , and behavior modeling .


Primary outcome measures were technical performance as measured on global and procedure-specific rating scales , and surgical safety parameters , measured by error count .


Operative performance was assessed by blinded video analysis of the first and last cases recorded by the participants during their rotation .


Twenty residents were randomized and 18 completed the study .


At posttraining the CSC group ( n = 9 ) scored significantly higher on a procedure-specific skill scale compared with the CT group ( n = 9 ) [ median , 3.90 ( interquartile range , 3.68-4 .30 ) vs 3.60 ( 2.98-3 .70 ) , P = 0.017 ] , and made fewer technical errors [ 10 ( 7-13 ) vs 18 ( 13-21 ) , P = 0.003 ] .


Significant within-group improvements for all skill metrics were only noted in the CSC group .


Comprehensive surgical coaching enhances surgical training and results in skill acquisition superior to conventional training .


To compare and contrast three different training modalities for fit testing N-95 respirator face masks .


Block randomized interventional study .


Urban university .


Two hundred eighty-nine medical students .


Students were randomly assigned to video , lecture , or slide show to evaluate the effectiveness of the methods for fit testing large groups of people .


Ease of fit and success of fit for each instructional technique .


Mask 1 was a Kimberly-Clark duckbill N-95 respirator mask , and mask 2 was a 3M carpenters N-95 respirator mask .


`` Ease of fit '' was defined as the ability to successfully don a mask in less than 30 seconds .