In LUX-Lung 6 , median overall survival was 23.1 months ( 95 % CI 20.4-27 .3 ) in the afatinib group and 23.5 months ( 18.0-25 .6 ) in the gemcitabine-cisplatin group ( HR 0.93 , 95 % CI 0.72-1 .22 , p = 0.61 ) .


However , in preplanned analyses , overall survival was significantly longer for patients with del19-positive tumours in the afatinib group than in the chemotherapy group in both trials : in LUX-Lung 3 , median overall survival was 33.3 months ( 95 % CI 26.8-41 .5 ) in the afatinib group versus 21.1 months ( 16.3-30 .7 ) in the chemotherapy group ( HR 0.54 , 95 % CI 0.36-0 .79 , p = 0.0015 ) ; in LUX-Lung 6 , it was 31.4 months ( 95 % CI 24.2-35 .3 ) versus 18.4 months ( 14.6-25 .6 ) , respectively ( HR 0.64 , 95 % CI 0.44-0 .94 , p = 0.023 ) .


By contrast , there were no significant differences by treatment group for patients with EGFR Leu858Arg-positive tumours in either trial : in LUX-Lung 3 , median overall survival was 27.6 months ( 19.8-41 .7 ) in the afatinib group versus 40.3 months ( 24.3-not estimable ) in the chemotherapy group ( HR 1.30 , 95 % CI 0.80-2 .11 , p = 0.29 ) ; in LUX-Lung 6 , it was 19.6 months ( 95 % CI 17.0-22 .1 ) versus 24.3 months ( 19.0-27 .0 ) , respectively ( HR 1.22 , 95 % CI 0.81-1 .83 , p = 0.34 ) .


In both trials , the most common afatinib-related grade 3-4 adverse events were rash or acne ( 37 [ 16 % ] of 229 patients in LUX-Lung 3 and 35 [ 15 % ] of 239 patients in LUX-Lung 6 ) , diarrhoea ( 33 [ 14 % ] and 13 [ 5 % ] ) , paronychia ( 26 [ 11 % ] in LUX-Lung 3 only ) , and stomatitis or mucositis ( 13 [ 5 % ] in LUX-Lung 6 only ) .


In LUX-Lung 3 , neutropenia ( 20 [ 18 % ] of 111 patients ) , fatigue ( 14 [ 13 % ] ) and leucopenia ( nine [ 8 % ] ) were the most common chemotherapy-related grade 3-4 adverse events , while in LUX-Lung 6 , the most common chemotherapy-related grade 3-4 adverse events were neutropenia ( 30 [ 27 % ] of 113 patients ) , vomiting ( 22 [ 19 % ] ) , and leucopenia ( 17 [ 15 % ] ) .


Although afatinib did not improve overall survival in the whole population of either trial , overall survival was improved with the drug for patients with del19 EGFR mutations .


The absence of an effect in patients with Leu858Arg EGFR mutations suggests that EGFR del19-positive disease might be distinct from Leu858Arg-positive disease and that these subgroups should be analysed separately in future trials .


Boehringer Ingelheim .


This study was to evaluate the characteristics of selective spinal anesthesia using 1 mg of bupivacaine combined with fentanyl or sufentanil in elderly patients undergoing transurethral resection of prostate .


Fifty-six patients were randomized into two groups .


The Fentanyl group received 0.5 % hyperbaric bupivacaine 0.2 mL + fentanyl 20 g +5 % dextrose 1.4 mL , and the Sufentanil group received 0.5 % hyperbaric bupivacaine 0.2 mL + sufentanil 5 g +5 % dextrose 1.7 mL intrathecally .


Intraoperative and postoperative characteristics were evaluated .


Patient satisfaction was assessed postoperatively .


Twenty-six patients in each group completed the study .


The median peak sensory block level was similar between two groups , but sensory regression time was longer in the Sufentanil group than the Fentanyl group ( p = 0.017 ) .


All patients were able to move themselves to the bed without any aid when they arrived at the admission room .


Pain scores were lower in the Sufentanil group than the Fentanyl group at postoperative 6 , 12 , and 18 hours ( p = 0.001 ) .


Compared to the Fentanyl group , the Sufentanil group required less postoperative analgesia ( p = 0.023 ) and the time to the first analgesic request was longer ( p = 0.025 ) .


Twenty-four of 26 patients ( 92.3 % ) in each group showed `` good '' satisfaction level .


Selective spinal anesthesia using 1 mg of bupivacaine with fentanyl or sufentanil provided appropriate sensory block level with spared motor function for transurethral resection of the prostate in elderly patients .


Intrathecal sufentanil was superior to fentanyl in postoperative analgesic quality .


Angina pectoris ( Angina ) is a medical condition related to myocardial ischemia .


Although acupuncture has been widely accepted as a clinical approach for angina , there is no sufficient evidence of its effectiveness against this syndrome , and its mechanisms have not yet been well elucidated .


We develop this protocol to confirm the clinical efficacy of electro-acupuncture on stable angina pectoris by needling on acupoint Neiguan ( PC6 ) .


Furthermore , we employ high-throughput sequencing technology to investigate the gene expression profiling and determine involvement of histone modifications in the regulation of genes after electro-acupuncture treatment .


A randomized , controlled , double-blinded ( assessor and patients ) trial will be carried out .


Sixty participants will be randomly assigned to two acupuncture treatment groups and one control group in a 1:1:1 ratio .


Participants in acupuncture groups will receive 12 sessions of electro-acupuncture treatment across 4 weeks , followed by a 12-week randomization period .


The acupuncture groups are divided into Neiguan ( PC6 ) on Pericardium Meridian of Hand-jueyin or a non-acupoint .


The primary clinical measure of effect is the frequency of angina attacks between these groups for four weeks after randomization .


RNAs are extracted from peripheral neutrophils collected from all participants on day 0 , day 30 , and week 16 , and are processed to RNA-Seq .


We then investigate profiles of histone modifications by ChIP-Seq , for H3 Lysine 4 ( H3K4me ) and acetylation of H3 Lysine 27 ( H3K27ac ) , in the presence or absence of acupuncture treatment .


This study determines the efficacy and mechanisms of electro-acupuncture on stable angina pectoris .


We focus on effectiveness of acupuncture on alleviating symptoms of myocardial ischemia and the gene regulation and the chromatin remodeling marks , including H3K4me1 , H3K4me2 , and H3K27ac , which could be key factors for regulating gene expressions caused by electro-acupuncture treatment at Neiguan .


This is the first genome-wide study of electro-acupuncture treatment in angina patients , and will provide valuable information for future studies in the fields of acupuncture and its underlying mechanisms .


Fourteen patients have been recruited since recruitment opened in November of 2012 .


This study is scheduled to end in November of 2014 .


ChiCTR-TRC-12002668 .


Despite prompt revascularization of acute myocardial infarction ( AMI ) , substantial myocardial injury may occur , in part a consequence of ischaemia reperfusion injury ( IRI ) .


There has been considerable interest in therapies that may reduce IRI .


In experimental models of AMI , sodium nitrite substantially reduces IRI .


In this double-blind randomized placebo controlled parallel-group trial , we investigated the effects of sodium nitrite administered immediately prior to reperfusion in patients with acute ST-elevation myocardial infarction ( STEMI ) .


A total of 229 patients presenting with acute STEMI were randomized to receive either an i.v. infusion of 70 mol sodium nitrite ( n = 118 ) or matching placebo ( n = 111 ) over 5 min immediately before primary percutaneous intervention ( PPCI ) .


Patients underwent cardiac magnetic resonance imaging ( CMR ) at 6-8 days and at 6 months and serial blood sampling was performed over 72 h for the measurement of plasma creatine kinase ( CK ) and Troponin I. Myocardial infarct size ( extent of late gadolinium enhancement at 6-8 days by CMR-the primary endpoint ) did not differ between nitrite and placebo groups after adjustment for area at risk , diabetes status , and centre ( effect size -0.7 % 95 % CI : -2.2 % , +0.7 % ; P = 0.34 ) .


There were no significant differences in any of the secondary endpoints , including plasma troponin I and CK area under the curve , left ventricular volumes ( LV ) , and ejection fraction ( EF ) measured at 6-8 days and at 6 months and final infarct size ( FIS ) measured at 6 months .


Sodium nitrite administered intravenously immediately prior to reperfusion in patients with acute STEMI does not reduce infarct size .


The Danish health care sector is reorganising based on disease management programmes designed to secure integrated and high quality chronic care across hospitals , general practitioners and municipalities .


The disease management programmes assign a central role to general practice ; and in the Capital Region of Denmark a facilitator-based intervention was undertaken to support the implementation of the programmes in general practice .


The purpose of the study was to assess the effectiveness of this semi-tailored facilitator-based intervention .


The study was a stepped-wedge , randomised , controlled trial among general practices in the Capital Region of Denmark .


The intervention group was offered three one-hour visits by a facilitator .


The intervention was semi-tailored to the perceived needs as defined by each general practice , and the practices could choose from a list of possible topics .


The control group was a delayed intervention group .


The primary outcome was change in the number of annual chronic disease check-ups .


Secondary outcomes were : changes in the number of annual check-ups for type 2 diabetes ( DM2 ) and chronic obstructive pulmonary disease ( COPD ) ; changes in the number of spirometry tests , changes in the use of ICPC diagnosis coding and patient stratification ; sign-up for a software program for patient overview ; and reduction in number of practices with few annual chronic disease check-ups .


We randomised 189 general practices : 96 practices were allocated to the intervention group and 93 to the delayed intervention group .


For the primary outcome , 94 and 89 practices were analysed .


Almost every outcome improved from baseline to follow-up in both allocation groups .


At follow-up there was no difference between allocation groups for the primary outcome ( p = 0.1639 ) .


However , some secondary outcomes favoured the intervention : a higher reported use of ICPC diagnosis coding for DM2 and COPD ( p = 0.0050 , p = 0.0243 respectively ) , stratification for COPD ( p = 0.0185 ) and a faster initial sign-up rate for the software program .


The mixed results from this study indicate that a semi-tailored facilitator-based intervention of relatively low intensity is unlikely to add substantially to the implementation of disease management programmes for DM2 and COPD in a context marked by important concurrent initiatives ( including financial incentives and mandatory registry participation ) aimed at moving all practices towards changes in chronic care .


ClinicalTrials.gov : NCT01297075 .


To compare the incidence of infection after minor surgery conducted using non-sterile clean boxed gloves with surgery conducted using sterile gloves .


Prospective randomised controlled single-centre trial testing for non-inferiority in infection rates .


Primary care regional centre , Queensland , Australia .


Consecutive patients presenting to participating general practitioners for a minor skin excision , between 30 June 2012 and 28 March 2013 , were eligible to participate .


The use of non-sterile clean boxed gloves was compared with normal treatment using sterile gloves in the control group .


Wound infection , assessed at the time of removal of sutures , and other adverse events .


Four hundred and ninety-three consecutive patients presenting for minor skin excisions were randomly allocated to the two treatment groups : non-sterile clean boxed gloves ( n = 250 ) or sterile gloves ( n = 243 ) .


Four hundred and seventy-eight patients contributed data for analysis ( 241 non-sterile , 237 sterile gloves ) .


The incidence of infection in the non-sterile gloves group ( 8.7 % ; 95 % CI , 4.9 % -12.6 % ) was significantly non-inferior compared with the incidence in the control group ( 9.3 % ; 95 % CI , 7.4 % -11.1 % ) .


The two-sided 95 % CI for the difference in infection rate ( - 0.6 % ) was - 4.0 % to 2.9 % , and did not reach the predetermined margin of 7 % which had been assumed as the non-inferiority limit .


RESULTS of the intention-to-treat analysis were confirmed by per-protocol and sensitivity analyses .


There were no important adverse effects .


Our study suggests that in regard to wound infection , non-sterile clean boxed gloves are not inferior to sterile gloves for minor skin excisions in general practice .


ACTRN12612000698875 .


Reports of the accuracy of existing neuromonitoring methods for detecting or preventing medial malpositioning of thoracic pedicle screws have varied widely in their claimed effectiveness .


The object of this study was to develop , test , and validate a novel neuromonitoring method for preventing medial malpositioning of pedicle screws in the thoracic spine during surgery .


This is a prospective , blinded and randomized study using a novel combination of input ( 4-pulse stimulus trains delivered within the pedicle track ) and output ( evoked electromyography from leg muscles ) to detect pedicle track trajectories that-once implanted with a screw-would cause that screw to breach the pedicle 's medial wall and encroach upon the spinal canal .


For comparison , the authors also used screw stimulation as an input and evoked electromyogram from intercostal and abdominal muscles as output measures .


Intraoperative electrophysiological findings were compared with postoperative CT scans by multiple reviewers blinded to patient identity or intraoperative findings .


Data were collected from 71 patients , in whom 802 screws were implanted between the T-1 and L-1 vertebral levels .


A total of 32 screws ended up with screw threads encroaching on the spinal canal by at least 2 mm .


Pulse-train stimulation within the pedicle track using a ball-tipped probe and electromyography from lower limb muscles correctly predicted all 32 ( 100 % ) of these medially malpositioned screws .


The combination of pedicle track stimulation and electromyogram response from leg muscles proved to be far more effective in predicting these medially malpositioned screws than was direct screw stimulation and any of the target muscles ( intercostal , abdominal , or lower limb muscles ) we monitored .


Based on receiver operating characteristic analysis , the combination of 10-mA ( lower alarm ) and 15-mA stimulation intensities proved most effective for detection of pedicle tracks that ultimately gave rise to medially malpositioned screws .


Additional results pertaining to the impact of feedback of these test results on surgical decision making are provided in the companion report .


This novel neuromonitoring approach accurately predicts medially malpositioned thoracic screws .


The approach could be readily implemented within any surgical program that is already using contemporary neuromonitoring methods that include transcranial stimulation for monitoring motor evoked potentials .


Oxidative stress is involved in lead toxicity .


This suggests that some antioxidants may play a role in the treatment of lead poisoning .


In the light of this , the aim of the study was to determine whether beta-carotene administration reduces oxidative stress and homocysteine level in workers chronically exposed to lead .


The exposed population included healthy male workers exposed to lead who were randomly divided into 2 groups ( mean blood lead level ca. 44 microg/dl ) .


Workers in the 1st group ( N = 49 , reference group ) had no antioxidants , drugs , vitamins or dietary supplements administered , while workers in the 2nd group ( N = 33 ) had beta-carotene administered in a dose of 10 mg per day for 12 weeks .


Biochemical analysis included markers of lead-exposure and the level of malondialdehyde ( MDA ) , an oxidative stress biomarker .


We also measured the level of homocysteine ( Hcy ) and thiol groups as well as the activity of superoxide dismutase ( SOD ) and its isoenzyme EC-SOD in serum .


After supplementation , the level of MDA significantly decreased , compared to baseline , by 16 % , and to the reference group .


When compared to the reference group , Hcy level was also significantly decreased .


However , the level of thiol groups was significantly higher after supplementation with beta-carotene compared to the reference group .


Analogically , the activity of SOD and EC-SOD was significantly higher compared to the baseline and to the reference group .


Despite some controversies over antioxidant properties of beta-carotene , our results indicate that its antioxidant action could provide some beneficial effects in lead poisoning independent of chelation .


Public-health guidelines recommend patients with congenital heart disease to exercise .


Studies have shown that patients with congenital heart disease can improve physical exercise capacity .


The effect of training on regional ventricular performance has hardly been studied .


We performed a pilot study to assess whether an exercise training program would result in adverse changes of regional ventricular performance in patients with corrected tetralogy of Fallot .


Multicenter prospective randomized controlled pilot study in patients with tetralogy of Fallot aged 10 to 25 years .


A 12-week standardized aerobic dynamic exercise training program ( 3 one-hour sessions per week ) was used .


Pre - and post-training cardiopulmonary exercise tests , MRI , and echocardiography , including tissue-Doppler imaging , were performed .


Patients were randomized to the exercise group ( n = 28 ) or control group ( n = 20 ) .


One patient in the exercise group dropped out .


Change in tissue-Doppler imaging parameters was similar in the exercise group and control group ( change in right ventricle free wall peak velocity E ' exercise group , 0.82.6 cm/s ; control group , 0.94.1 ; peak velocity A ' exercise group , 0.42.4 m/s ; control group 4.618.1 cm/s ) .


This randomized controlled pilot study provides preliminary data suggesting that regional ventricular performance is well maintained during 3-month aerobic dynamic exercise training in children and young adults with repaired tetralogy of Fallot .


This information might help patients adhere to current public-health guidelines .


URL : http / / : www.trialregister.nl .


Unique identifier : NTR2731 .


Incident syphilis infections continue to be especially prevalent among a core group of HIV-infected men who have sex with men ( MSM ) .


Because of synergy between syphilis and HIV infections , innovative means for controlling incident syphilis infections are needed .


Thirty MSM who had syphilis twice or more since their HIV diagnosis were randomized to receive either daily doxycycline prophylaxis or contingency management ( CM ) with incentive payments for remaining free of sexually transmitted diseases ( STDs ) .


Participants were tested for the bacterial STDs gonorrhea ( Neisseria gonorrhoeae ) , chlamydia ( Chlamydia trachomatis ) and syphilis at weeks 12 , 24 , 36 , and 48 and completed a behavioral risk questionnaire during each visit to assess number of partners , condom use , and drug use since the last visit .


Generalized linear mixed models were used to analyze differences between arms in STD incidence and risk behaviors at follow-up .


Doxycycline arm participants were significantly less likely to test positive for any selected bacterial STD during 48 weeks of follow-up ( odds ratio , 0.27 ; confidence interval , 0.09-0 .83 ) compared with CM arm participants ( P = 0.02 ) .


There were no significant self-reported risk behavior differences between the doxycycline and CM arms at follow-up .


Daily doxycycline taken prophylactically was associated with a decreased incidence of N. gonorrhoeae , C. trachomatis , or syphilis incident infections among a core group of HIV-infected MSM at high risk for these infections .


Safe and effective biomedical tools should be included in the efforts to control transmission of syphilis , especially in this population .


A randomized clinical trial should be conducted to confirm and extend these findings .


The individual placement and support ( IPS ) model of supported employment has been implemented throughout North America and Europe , with multiple randomized controlled trials documenting its effectiveness , but it has not been widely implemented in Asia .


To date , no rigorous evaluations of IPS have been conducted in Japan .


We sought to evaluate whether IPS could be implemented in Japan and produce superior competitive employment outcomes compared with conventional vocational services .


We employed a randomized controlled trial with a 6-month follow-up ; 18 participants were randomly assigned to IPS and 19 to conventional vocational services .


We assessed competitive employment rates , hours and weeks worked , and wages earned .


Over the 6-month follow-up period , IPS participants were more likely than those in usual care to work competitively ( 44.4 % for IPS vs. 10.5 % for controls , p = .022 ) , work more hours ( mean of 168 hr for IPS vs. 41 hr for controls , p = .002 ) , and work more weeks ( mean of 6.4 weeks for IPS vs. 1.8 weeks for controls , p = .003 ) .


IPS can be implemented in Japan and yield better competitive employment outcomes than conventional vocational services .


Adoption of the IPS model might have a dramatic impact on the mental health service system in Japan where psychiatric hospitals play a central role in mental health care .


Procalcitonin-guided antibiotic therapy for community-acquired pneumonia is effective and safe .


However , the usefulness of procalcitonin for aspiration pneumonia and its nutrition-related outcomes are unknown .


We conducted a noninferiority randomized controlled study in patients with aspiration pneumonia who were admitted to our hospital between September 2010 and January 2012 .


We randomly assigned 105 patients to groups with different durations of antibiotic therapy based on the procalcitonin levels upon admission ( procalcitonin group ) or according to the standard guidelines ( control group ) .


The primary endpoints were relapse of aspiration pneumonia and death within 30 days , with a predefined noninferiority boundary of 10 % .


Secondary endpoints included duration of antibiotic exposure .


Furthermore , we conducted a retrospective analysis of the prognostic factors that determined continuation of oral nutritional intake , relapse of pneumonia , and in-hospital death .


The rate of relapse and death within 30 days were similar in the procalcitonin and control groups ( 25 % versus 37.5 % ; difference , -12.5 % ; 95 % confidence interval , -30.9 % to 5.9 % ) .


Procalcitonin-guided antibiotic therapy significantly shortened the median duration of antibiotic exposure ( 5 versus 8 days ; p < 0.0001 ) ; however , the continuation of oral intake was not increased ( 56 % versus 50 % ; p = 0.54 ) .


A multivariable analysis showed a significant association between the continuation of oral nutritional intake and the body mass index upon admission .


Procalcitonin-guided antibiotic therapy for aspiration pneumonia can shorten the duration of antibiotic exposure , but it does not increase the continuation of oral intake ( UMIN000004800 ) .


To evaluate the clinical efficacy of acupuncture for treatment of diarrhea-predominant irritable bowel syndrome and discuss its action mechanism .


Fifty-seven cases were randomly divided into two groups .


The acupuncture group ( 29 cases ) was treated with acupuncture at Taichong ( LR 3 ) , Zusanli ( ST 36 ) and Sanyinjiao ( SP 6 ) etc. , once a day and 5 times per week .


The medication group ( 28 cases ) was treated with oral administration of pinaverium ( 50 mg each time , 3 times a day ) and live combined bifidobacterium and lactobacillus tablet ( 4 tablets each time , 3 times a day ) .


Four weeks were taken as a treatment course in both groups .


Before and after treatment ELISA method was applied to measure the level of serum 5-HT of the patients in two groups .


The scores of clinical symptoms were observed before treatment , after one and four weeks of treatment and 3 months after treatment , respectively .


The level of serum 5-HT was significantly reduced in the acupuncture group and medication group ( P < 0.01 , P < 0.05 ) , which had no statistical difference between two groups ( P > 0.05 ) .


Compared with the medication group , the scores of clinical symptoms were obviously improved in the acupuncture group after one and four weeks of treatment and 3 months after treatment ( P < 0.01 , P < 0.05 ) .


The total effective rate was 89.66 % ( 26/29 ) in the acupuncture group , which was superior to 67.85 % ( 19/28 ) in the medication group ( P < 0.05 ) .


The efficacy of acupuncture is superior to that of medicine in the treatment of diarrhea-predominant irritable bowel syndrome .


The acupuncture treatment could reduce the visceral sensitivity , improve the intestinal motility and regulate the imbalance of brain-intestine interactive function .


Recurrent Clostridium difficile infection ( CDI ) with poor response to standard antimicrobial therapy is a growing medical concern .


We aimed to investigate the outcomes of fecal microbiota transplant ( FMT ) for relapsing CDI using a frozen suspension from unrelated donors , comparing colonoscopic and nasogastric tube ( NGT ) administration .


Healthy volunteer donors were screened and a frozen fecal suspension was generated .


Patients with relapsing/refractory CDI were randomized to receive an infusion of donor stools by colonoscopy or NGT .


The primary endpoint was clinical resolution of diarrhea without relapse after 8 weeks .


The secondary endpoint was self-reported health score using standardized questionnaires .


A total of 20 patients were enrolled , 10 in each treatment arm .


Patients had a median of 4 ( range , 2-16 ) relapses prior to study enrollment , with 5 ( range , 3-15 ) antibiotic treatment failures .


Resolution of diarrhea was achieved in 14 patients ( 70 % ) after a single FMT ( 8 of 10 in the colonoscopy group and 6 of 10 in the NGT group ) .


Five patients were retreated , with 4 obtaining cure , resulting in an overall cure rate of 90 % .


Daily number of bowel movements changed from a median of 7 ( interquartile range [ IQR ] , 5-10 ) the day prior to FMT to 2 ( IQR , 1-2 ) after the infusion .


Self-ranked health score improved significantly , from a median of 4 ( IQR , 2-6 ) before transplant to 8 ( IQR , 5-9 ) after transplant .


No serious or unexpected adverse events occurred .


In our initial feasibility study , FMT using a frozen inoculum from unrelated donors is effective in treating relapsing CDI .


NGT administration appears to be as effective as colonoscopic administration .


NCT01704937 .


To observe the effect of catgut implantation at acupoint on the content of tumor necrosis factor alpha ( TNF-alpha ) , and to explore its mechanism for treatment of ankylosing spondylitis ( AS ) .


Seventy-four AS patients were randomly assigned to the observation group and the control group by digit random table , 37 in each group .


Patients in the control group took Sulfasalazine Enteric-coated Tablet ( SECT ) , 0.5 g each time , three times daily for 3 months .


Those in the observation group additionally received catgut implantation at acupoint for 3 months .


Changes of visual analogue scale ( VAS ) , Schober test , pillow wall distance , thoracic activity , erythrocyte sedimentation rate ( ESR ) , C reactive protein ( CRP ) , and TNF-alpha were compared after 3 months of treatment .


There was obvious change in VAS , Schober test , pillow wall distance , thoracic activity , ESR , CRP , and TNF-alpha after treatment in the both groups , showing statistical difference when compared with before treatment ( P < 0.05 , P < 0.01 ) .


The aforesaid indices were obviously improved after treatment in the observation group ( P < 0.05 , P < 0.01 ) .


Catgut implantation at acupoint , as an assistant therapy , could significantly improve clinical symptoms and signs , decrease the level of TNF-alpha , and its effect was superior to that of oral SECT administration alone .


In Scotland most women get emergency contraception ( EC ) from pharmacies .


Pharmacists currently can not provide effective ongoing contraception after EC .


In this pilot study , we aimed to determine the feasibility of a larger study designed to ascertain if pharmacy-based interventions can increase the uptake of effective contraception after EC .


This is a pilot study of women presenting for levonorgestrel EC to community pharmacies in Edinburgh , UK , in 2012 .


Pharmacies were cluster randomized to provide either standard care or one of two interventions : ( a ) one packet of progestogen-only pills ( POPs ) , giving women 1 month to arrange ongoing contraception ; ( b ) invitation to present the empty EC packet to a family planning clinic ( FPC ) for contraceptive advice ( rapid access ) .


One hundred sixty-eight women were recruited from 11 pharmacies to POP ( n = 56 ) , rapid access ( n = 58 ) and standard care ( N = 54 ) groups , respectively .


Telephone follow-up was conducted successfully in 102 women ( 61 % ) 6-8 weeks later to determine current contraceptive use .


In the POP arm , 35/39 ( 90 % ) women used the pills provided , and 9/28 women ( 32 % ) in the rapid access arm attended the FPC .


The proportion of women using effective contraception at follow-up was significantly greater in both POP [ 56 % ( 22/39 ) , p = < 0.001 ] and rapid access [ 52 % ( 13/25 ) , p = 0.006 ] groups compared to standard care [ 16 % ( 5/31 ) ] .


The relative probability of a woman using an effective method of contraception versus barrier/no method , after use of EC , was 3.13 [ 95 % confidence interval ( CI ) , 1.90-5 .13 ] in the POP group and 2.57 ( 95 % CI , 1.55-4 .27 ) in the rapid access group .


This promising pilot study suggests that simple pharmacy-based interventions may increase the uptake of effective contraception after EC .


A larger study is required to provide further validation of these findings .


For women obtaining EC from a pharmacy , simple interventions such as supplying 1 month of a POP , or offering rapid access to a FPC , hold promise as strategies to increase the uptake of effective contraception after EC .


Dietary triacylglycerols ( TAGs ) containing palmitic acid in the sn-2 position might impair insulin release and increase plasma glucose .


We tested this hypothesis by comparing postprandial responses to fats with varying proportions of palmitic acid in the sn-2 position .


Using a crossover-designed randomized controlled trial in healthy men ( n = 25 ) and women ( n = 25 ) , we compared four meals on postprandial changes in glucose ( primary outcome ) , insulin , C-peptide , glucose , glucose-dependent insulinotropic polypeptide ( GIP ) and polypeptide YY ( PYY ) concentrations .


The meals provided 14g protein , 85g carbohydrate and 50g test fat , supplied as high oleic sunflower ( HOS ) oil ( control ) , palm olein ( PO ) , interesterified palm olein ( IPO ) and lard containing 0.6 , 9.2 , 39.1 and 70.5 mol % palmitic acid at sn-2 , respectively .


No differences in plasma glucose , insulin and C-peptide response between meals were found .


GIP release was lower ( P < 0.001 ) for IPO and lard compared with HOS and PO meals ; the maximal increments ( geometric mean and 95 % confidence interval ) for HOS , PO , IPO and lard were 515 ( 468 , 569 ) , 492 ( 448 , 540 ) , 398 ( 350 , 452 ) and 395 ( 364 , 429 ) ng/l , respectively .


There was a trend for the postprandial increase in PYY to be lower in women on the IPO and lard meals than those on the HOS and PO meals .


Dietary TAGs with an increased proportion of palmitic acid in the sn-2 position do not have acute adverse effects on the insulin and glucose response to meals in healthy men and women , but they decrease GIP release .


Although recent studies have documented high-risk drinking occurring during Spring Break ( SB ) , particularly on SB trips with friends , published intervention studies are few .


In the present study , we evaluated the efficacy of event specific prevention strategies for reducing SB drinking among college students , compared to general prevention strategies and an assessment-only control group , as well as evaluated inclusion of peers in interventions and mode of intervention delivery ( in-person vs. web ) .


Participants included 783 undergraduates ( 56.1 % women ; average age = 20.5 years ) intending to go on a SB trip with friends as well as to drink heavily on at least 1 day of SB .


Participants completed assessments prior to SB and were randomized to 1 of 5 intervention conditions : SB in-person Brief Alcohol Screening and Intervention for College Students ( BASICS ; Dimeff , Baer , Kivlahan , & Marlatt , 1999 ) , SB web BASICS , SB in-person BASICS with friend , SB web BASICS with friend , general BASICS , or an attention control condition .


Follow-up assessment was completed 1 week after SB .


Although the SB web BASICS ( with and without friends ) and general BASICS interventions were not effective at reducing SB drinking , results indicated significant intervention effects for SB in-person BASICS in reducing SB drinking , particularly on trip days .


Follow-up analyses indicated that change in descriptive norms mediated treatment effect and reductions in drinking , whereas SB drinking intentions and positive expectancies did not .


Overall , results suggest that an in-person SB-specific intervention is effective at reducing SB drinking , especially during trips .


In contrast , interventions that contain non-SB-related content , are web-based , or seek to involve friends may be less effective at reducing SB drinking .


This study aimed to improve our understanding of static and dynamic lower extremity sensory perception and the impact of sensory impairments on the control of walking in stroke survivors .


Using a custom , real-time unloading system , we tested load perception at heel strike , mid stance and push off in 10 stroke survivors and compared their performance to 10 age-matched and 5 young adult control subjects .


Dynamic load perception was based on a judgment of which leg was bearing more load , which was altered on a step by step basis .


We also examined lower extremity static load perception , coordination , proprioception , balance , and gait symmetry .


The stroke survivors performed significantly worse than the control subjects in dynamic load perception , coordination , proprioception , balance and gait symmetry .


Gait symmetry correlated with static and dynamic load perception measures but not with age , proprioception , coordination , and balance .


Sensory deficits related to load detection in the impaired limb could result in an increased uncertainty of limb load and a gait strategy in which stroke survivors minimize loading of the impaired limb .


This new method of measuring lower extremity dynamic load perception provides a framework for understanding gait-related sensory impairments in stroke survivors .


To investigate the impact of respiratory muscle endurance training ( RMET ) on lung function and exercise performance in athletes with high lesion level paraplegia .


This was a case-control intervention study .


Sport and exercise science laboratories and bike path .


Twelve competitive handbike athletes with high lesion level paraplegia matched by lesion and fitness level in training ( T ) group ( 7 ) and control ( C ) group ( 5 ) .


The T group performed 20 RMET training sessions over a 4-week period using a SpiroTiger .


Each session lasted for 30 minutes .


The C group did not perform any RMET .


Resting lung function , respiratory muscle endurance , and exercise performance ( arm cranking maximal incremental test and simulated handbike time trial ) .


Resting lung function was not different between groups and did not change with the intervention .


After RMET , the respiratory muscle endurance was significantly increased by 27 % in the T group but did not alter in the C group .


Final minute ventilation was increased from 89 20 L/min to 112 20 L/min after RMET in the T group and the sensation of dyspnea decreased ( P < 0.05 ) .


Peak oxygen consumption , peak mechanical power output , and handbike time trial performance were not different between groups and did not change with the RMET intervention .


A short-term RMET intervention in handbike athletes with high lesion level paraplegia improved respiratory muscle endurance but had little impact on overall exercise performance .


To assess the effectiveness of pilates method on patients with chronic non-specific low back pain ( LBP ) .


A randomized controlled trial was carried out in sixty patients with a diagnosis of chronic non-specific LBP .


Patients were randomly assigned to one of two groups : Experimental Group ( EG ) that maintained medication treatment with use of NSAID and underwent treatment with the pilates method and Control Group ( CG ) that continue medication treatment with use of NSAID and did not undergo any other intervention .


A blinded assessor performed all evaluations at baseline ( T0 ) , after 45 , 90 , and 180 days ( T45 , T90 and T180 ) for : pain ( VAS ) , function ( Roland Morris questionnaire ) , quality of life ( SF-36 ) , satisfaction with treatment ( Likert scale ) , flexibility ( sit and reach test ) and NSAID intake .


The groups were homogeneous at baseline .


Statistical differences favoring the EG were found with regard to pain ( P < 0.001 ) , function ( P < 0.001 ) and the quality of life domains of functional capacity ( P < 0.046 ) , pain ( P < 0.010 ) and vitality ( P < 0.029 ) .


Statistical differences were also found between groups regarding the use of pain medication at T45 , T90 and T180 ( P < 0.010 ) , with the EG taking fewer NSAIDs than the CG .


The pilates method can be used by patients with LBP to improve pain , function and aspects related to quality of life ( functional capacity , pain and vitality ) .


Moreover , this method has no harmful effects on such patients .


Obese children tend to consume less dietary folate , which is an important cofactor in remethylation of homocysteine to methionine .


The deficiency of folate can lead to hyperhomocysteinemia .


To determine whether folic acid supplementation could reduce plasma homocysteine in obese children .


Obese children , aged 9-15 years with body mass index > median plus 2 SD according to WHO reference , were randomly assigned to 2 groups : receiving either 5 mg folic acid or placebo for 2 months .


Fasting homocysteine , creatinine , folate , vitamin B12 , insulin , glucose and lipid profiles were taken at baseline and the end of the study .


Dietary vitamin B12 , folate intake and physical activity were assessed using validated questionnaires .


Fifty obese children ( 31 boys and 19 girls ) took part in the study .


Their mean age was 10.9 1.6 years and mean BMI Z-score was 3.41 0.69 .


After the intervention , plasma homocysteine decreased by 15.75 % and 6.99 % in the folic acid and placebo group , respectively ( mean difference 8.76 % ; 95 % CI : 0.26 % , 17.25 % , p = 0.044 ) .


This divergence was more pronounced in boys and it remained significant after adjusting for baseline homocysteine and other confounders .


Subgroup analysis showed a larger magnitude of plasma homocysteine reduction in the low folate group ( mean difference 12.24 % ; 95 % CI : 1.39 % , 23.09 % ) .


The homocysteine lowering effect of folic acid supplementation was found in obese children , especially in boys and those with low serum folate .


Further long-term interventional studies are needed to determine the effects of the lowered plasma homocysteine on the cardiovascular outcomes of obese children .


This trial was registered on clinicaltrials.gov ( NCT01766310 ) .


The purpose of this study was to evaluate whether simple bone cysts ( SBC ) resolve with age .


Twenty four subjects with SBC who participated in a prior randomized clinical trial but had not healed at trial conclusion were evaluated for cyst healing .


The following clinical and radiographic data were evaluated : age , sex , pain ( Visual Analogue Scale ) , functional health ( Short Form 36 ) , subsequent fracture , involved bone , cyst area ( cm ) , distance from physis ( cm ) , endosteal thickening ( yes/no ) , scalloping ( no new scalloping/new scalloping ) , opacity/radiolucency ( as is ) , loculation ( yes/no ) , trabeculation ( yes/no ) , tubulation ( yes/no ) , transition zone ( sharp/wide ) , geographic borders ( geographic nonpermeative/nongeographic permeative ) , radiodense rim ( > 50 % / no rim ) , and growth plate status ( open/closed ) .


Cyst healing was graded as : 1-cyst clearly visible ; 2-cyst visible but multilocular and opaque ; 3-sclerosis around or within a partially visible cyst ; or 4-complete healing with obliteration of cyst .


Healing was defined as grade 4 .


Of 24 subjects , 15 ( 63 % ) were male , 18 ( 75 % ) cysts were located in the humerus , and 4 ( 25 % ) in the femur .


Patients were followed for 7.01.0 years following initial treatment with a mean age at follow-up of 17.23.2 years and 14 ( 87 % ) of growth plates were closed .


Pain was minimal ( 0.6 / 10 ) , function was high ( 91/100 ) , and none of the patients had experienced subsequent fractures .


Although distance from physeal scar had increased ( P < 0.0001 ) , cyst area reduction ( P < 0.1 ) and overall cyst healing ( P < 0.2 ) had not changed .


Of the 24 subjects , none were graded as healed at time of follow-up .


Of the remaining radiographic variables , only decreased loculation ( P < 0.02 ) and increased endosteal thickening ( P < 0.04 ) showed significant changes .


Despite the assumption that most SBC will resolve with skeletal maturity , this study indicates that none of the cysts were graded as completely healed although 87 % of growth plates were closed .


Growth plate closure may not signify healing of SBC and although symptoms and fractures are rare , further studies are needed to follow patients with SBC through early adulthood .


Lifestyle interventions among people with impaired glucose tolerance reduce the incidence of diabetes , but their effect on all-cause and cardiovascular disease mortality is unclear .


We assessed the long-term effect of lifestyle intervention on long-term outcomes among adults with impaired glucose tolerance who participated in the Da Qing Diabetes Prevention Study .


The study was a cluster randomised trial in which 33 clinics in Da Qing , China-serving 577 adults with impaired glucose tolerance-were randomised ( 1:1:1:1 ) to a control group or lifestyle intervention groups ( diet or exercise or both ) .


Patients were enrolled in 1986 and the intervention phase lasted for 6 years .


In 2009 , we followed up participants to assess the primary outcomes of cardiovascular mortality , all-cause mortality , and incidence of diabetes in the intention-to-treat population .


Of the 577 patients , 439 were assigned to the intervention group and 138 were assigned to the control group ( one refused baseline examination ) .


542 ( 94 % ) of 576 participants had complete data for mortality and 568 ( 99 % ) contributed data to the analysis .


174 participants died during the 23 years of follow-up ( 121 in the intervention group vs 53 in the control group ) .


Cumulative incidence of cardiovascular disease mortality was 11.9 % ( 95 % CI 8.8-15 .0 ) in the intervention group versus 19.6 % ( 12.9-26 .3 ) in the control group ( hazard ratio [ HR ] 0.59 , 95 % CI 0.36-0 .96 ; p = 0.033 ) .


All-cause mortality was 28.1 % ( 95 % CI 23.9-32 .4 ) versus 38.4 % ( 30.3-46 .5 ; HR 0.71 , 95 % CI 0.51-0 .99 ; p = 0.049 ) .


Incidence of diabetes was 72.6 % ( 68.4-76 .8 ) versus 89.9 % ( 84.9-94 .9 ; HR 0.55 , 95 % CI 0.40-0 .76 ; p = 0.001 ) .


A 6-year lifestyle intervention programme for Chinese people with impaired glucose tolerance can reduce incidence of cardiovascular and all-cause mortality and diabetes .


These findings emphasise the long-term clinical benefits of lifestyle intervention for patients with impaired glucose tolerance and provide further justification for adoption of lifestyle interventions as public health measures to control the consequences of diabetes .


Centers for Disease Control and Prevention , WHO , the China-Japan Friendship Hospital , Da Qing First Hospital .


To our knowledge , prior research has not examined the effects of magnesium supplementation on metabolic status and pregnancy outcomes in maternal-child dyads affected by gestational diabetes ( GDM ) .


This study was designed to assess the effects of magnesium supplementation on metabolic status and pregnancy outcomes in magnesium-deficient pregnant women with GDM .


A randomized , double-blind , placebo-controlled clinical trial was performed in 70 women with GDM .


Patients were randomly assigned to receive either 250 mg magnesium oxide ( n = 35 ) or a placebo ( n = 35 ) for 6 wk .


Fasting blood samples were taken at baseline and after a 6-wk intervention .


The change in serum magnesium concentration was greater in women consuming magnesium than in the placebo group ( +0.06 0.3 vs. -0.1 0.3 mg/dL , P = 0.02 ) .


However , after controlling for baseline magnesium concentrations , the changes in serum magnesium concentrations were not significantly different between the groups .


Changes in fasting plasma glucose ( -9.7 10.1 vs. +1.8 8.1 mg/dL , P < 0.001 ) , serum insulin concentration ( -2.1 6.5 vs. +5.7 10.7 IU/mL , P = 0.001 ) , homeostasis model of assessment-estimated insulin resistance ( -0.5 1.3 vs. +1.4 2.3 , P < 0.001 ) , homeostasis model of assessment-estimated - cell function ( -4.0 28.7 vs. +22.0 43.8 , P = 0.006 ) , and the quantitative insulin sensitivity check index ( +0.004 0.021 vs. -0.012 0.015 , P = 0.005 ) in supplemented women were significantly different from those in women in the placebo group .


Changes in serum triglycerides ( +2.1 63.0 vs. +38.9 37.5 mg/dL , P = 0.005 ) , high sensitivity C-reactive protein ( -432.8 2521.0 vs. +783.2 2470.1 ng/mL , P = 0.03 ) , and plasma malondialdehyde concentrations ( -0.5 1.6 vs. +0.3 1.2 mol/L , P = 0.01 ) were significantly different between the supplemented women and placebo group .


Magnesium supplementation resulted in a lower incidence of newborn hyperbilirubinemia ( 8.8 % vs. 29.4 % , P = 0.03 ) and newborn hospitalization ( 5.9 % vs. 26.5 % , P = 0.02 ) .


Magnesium supplementation among women with GDM had beneficial effects on metabolic status and pregnancy outcomes .


This trial was registered at www.irct.ir as IRCT201503055623N39 .


Physical performances and cognition are positively related in cognitively healthy people .


The aim of this study was to examine whether physical performances are related to specific cognitive functioning in older people with mild to severe cognitive impairment .


This cross-sectional study included 134 people with a mild to severe cognitive impairment ( mean age 82 years ) .


Multiple linear regression was performed , after controlling for covariates and the level of global cognition , with the performances on mobility , strength , aerobic fitness , and balance as predictors and working memory and episodic memory as dependent variables .


The full models explain 49-57 % of the variance in working memory and 40-43 % of episodic memory .


Strength , aerobic fitness , and balance are significantly associated with working memory , explaining 3-7 % of its variance , irrespective of the severity of the cognitive impairment .


Physical performance is not related to episodic memory in older people with mild to severe cognitive impairment .


Physical performance is associated with working memory in older people with cognitive impairment .


Future studies should investigate whether physical exercise for increased physical performance can improve cognitive functioning .


This trial is registered with ClinicalTrials.gov NTR1482 .


Different types of modified ultrafiltration ( MUF ) systems evaluated showed that none of the MUF techniques adhered to the normal venous to arterial blood flow dynamics .


This study compared a conventional arteriovenous modified ultrafiltration ( AVMUF ) system to a custom - designed venoarterial modified ultrafiltration ( VAMUF ) system .


Randomized , controlled clinical study conducted at the Northwest Armed Forces Military hospital in Tabuk , Saudi Arabia .


Sixty patients who underwent MUF during the years 2007 and 2009 were divided into 2 groups : the AVMUF ( n = 30 ) and the VAMUF ( n = 30 ) groups .


MUF was performed for a mean time of 12 minutes in both groups .


In AVMUF , blood was removed from the aorta , hemoconcentrated , and infused into the right atrium ( RA ) .


In VAMUF , blood flow was from the RA through a hemoconcentrator and re-infused into the aorta .


Results of the study showed that the VAMUF group required a shorter ventilation time ( P < .001 ) , in.tensive care unit ( ICU ) ( P = .003 ) , and hospital stay ( P = .007 ) than the AVMUF group .


Results also demonstrated a lower percentage of fluid balance ( P = .008 ) in the VAMUF group .


The systolic ( P < .001 ) and mean blood pres.sures ( P < .001 ) were significantly higher after VAMUF , with a decrease in heart rate ( P < .001 ) and central venous pressure ( P = .002 ) .


The VAMUF group showed a significantly greater decrease of creatinine ( P < .001 ) , serum lactacte ( P < .001 ) , and uric acid ( P < .027 ) over time with no significant differences in oximetry .


Results prove that VAMUF is a more physiological technique than AVMUF .


Interspinous spacers are a minimally invasive surgical alternative for patients with lumbar spinal stenosis ( LSS ) unresponsive to conservative care .


The purpose of this prospective , multicenter , randomized , controlled trial was to compare 2-year clinical outcomes in patients with moderate LSS treated with the Superion ( ) ( Experimental ) or the X-Stop ( ) , a FDA-approved interspinous spacer ( Control ) .


A total of 250 patients with moderate LSS unresponsive to conservative care were randomly allocated to treatment with the Experimental ( n = 123 ) or Control ( n = 127 ) interspinous spacer and followed through 2 years post-treatment .


Complication data were available for all patients and patient-reported outcomes were available for 192 patients ( 101 Experimental , 91 Control ) at 2 years .


Zurich Claudication Questionnaire ( ZCQ ) Symptom Severity and Physical Function scores improved 34 % to 36 % in both groups through 2 years ( all p < 0.001 ) .


Patient Satisfaction scores at 2 years were 1.8 0.9 with Experimental and 1.6 0.8 with Control .


Axial pain decreased from 59 26 mm at baseline to 21 26 mm at 2 years with Experimental and from 55 26 mm to 21 25 mm with Control ( both p < 0.001 ) .


Extremity pain decreased from 67 24 mm to 14 22 mm at 2 years with Experimental and from 63 24 mm to 18 23 mm with Control ( both p < 0.001 ) .


Back function assessed with the Oswestry Disability Index similarly improved with Experimental ( 37 12 % to 18 16 % ) and Control ( 39 12 % to 20 16 % ) ( both p < 0.001 ) .


Freedom from reoperation at the index level was 84 % for Experimental and 83 % for Control ( log-rank : p = 0.38 ) at 2 years .


Both interspinous spacers effectively alleviated pain and improved back function to a similar degree through 2 years in patients with moderate LSS who were unresponsive to conservative care .


NCT00692276 .


Sacrococcygeal pilonidal sinus is common in young men and may recur over time after surgery .


We investigated whether a factor exists that can aid in the determination of the preferred technique between the early Limberg flap and Karydakis flap techniques for treating recurrent pilonidal sinus .


This prospective and randomized study enrolled 71 patients with recurrent pilonidal sinus in whom the Limberg flap or Karydakis flap techniques were applied for reconstruction after excision .


Patients were divided into two groups as follows : 37 patients were treated with the Limberg flap technique and 34 patients were treated with the Karydakis flap technique .


Fluid collection , wound infection , flap edema , hematoma , partial wound separation , return to daily activities , pain score , complete healing time , painless seating and patient satisfaction were compared between the groups .


ClinicalTrial.gov : NCT02287935 .


The development rates of total fluid collection , wound infection , flap edema , hematoma , and partial wound separation were 9.8 % , 16 % , 7 % , 15 % and 4.2 % , respectively ; total flap necrosis was not observed in any patient ( p < 0.001 ) .


During the average follow-up of 28 months , no patients ( 0 % ) developed recurrent disease .


The two groups differed with respect to early surgical complications ( p < 0.001 ) .


In this study , use of the Limberg flap was associated with lower complication rates , shorter length of hospital stay , early return to work , low pain score , high patient satisfaction and better complete healing duration .


Therefore , we recommend the Limberg flap for treatment of recurrent pilonidal sinus .


Hyperbaric 2 % prilocaine produces a faster onset and shorter duration of spinal anesthesia than a plain solution .


The anesthetic profile could be improved by restricting the block to the operative side .


We compared unilateral versus conventional bilateral spinal anesthesia with hyperbaric 2 % prilocaine in day-case patients undergoing unilateral inguinal herniorrhaphy .


Eighty patients were randomly assigned to receive either conventional bilateral ( N. = 40 ) or unilateral ( N. = 40 ) spinal anesthesia with 50 mg hyperbaric prilocaine 2 % .


In the unilateral group , lateral decubitus was maintained for 10 minutes .


Sensory and motor block courses , time to first micturition , and side effects were recorded .


On the operated side , the highest sensory block was T8 ( T12-T2 ) in the unilateral and T9 ( T11-T4 ) in the bilateral group ( P = 0.0328 ) ; the time to motor ( 115 26 min in the unilateral and 108 24 min in the bilateral groups , P = 0.2350 ) and sensory ( 156 30 min in the unilateral and 158 26 min in the bilateral groups , P = 0.7550 ) block resolution was similar in both groups .


On the non-operated side , the unilateral group had a faster motor ( 64 48 , P < 0.001 ) and sensory ( 120 47 , P < 0.001 ) time to block resolution than the conventional group .


Restricted unilateral motor and sensory block was achieved in 30 % and 12.5 % of patients , respectively .


Time to voiding was shorter in the unilateral than in the conventional group ( 220 47 vs. 249 51 min , respectively , P = 0.0104 ) .


There were no significant differences in adequacy for surgery and side effects between the groups .


In day-case inguinal herniorrhaphy , attempting unilateral spinal anesthesia with 50 mg hyperbaric 2 % prilocaine produced faster time to voiding .


Eslicarbazepine acetate ( ESL ) is an anticonvulsant approved as an adjunctive therapy in adults with partial-onset seizures .


To evaluate the efficacy , safety and tolerability of ESL in the treatment of acute mania and prevention of recurrence in bipolar disorder I.


Two 3-week multicentre , double-blind , randomised , placebo-controlled studies in acute mania ( study BIA-2093-203 : dose titrated by response , ESL 600-1800mg or 800-2400mg , once-daily ; study BIA-2093-204 : fixed doses of 600 , 1200 and 1800mg , once-daily ) were followed by a recurrence prevention study consisting of a 2-week open-label period ( 900mg , once-daily ) continued by a double-blind , parallel-group , fixed dose ( 300 , 900 and 1800mg , once-daily ) period for a minimum of 6 months .


The primary endpoint was changed from baseline until the end of the 3-week treatment period in Young Mania Rating Scale ( YMRS ) in studies BIA-2093-203 and BIA-2093-204 , and the proportion of patients showing no worsening according to the Clinical Global Impressions - Bipolar Version ( CGI-BP ) over Part II in study BIA-2093-205 .


In study BIA-2093-203 ( n = 160 , ITT ) , neither dose group was statistically different from placebo in the primary endpoint , though the ESL 800-2400mg showed a greater reduction in YMRS score ( p = 0.0523 ) .


CGI-BP score changes for mania and overall bipolar illness indicate a significant improvement in patient symptomatology for the ESL 800-2400mg group ( from preceding and worst phase ) and for ESL 600-1800mg group ( from worst phase only ) when compared to placebo .


Study BIA-2093-204 ( n = 38 ) results were inconclusive due to premature termination caused by recruitment difficulties .


In study BIA-2093-205 ( n = 85 , ITT ) , at least 50 % of patients showed no worsening in all treatment groups ( p = 0.250 ) .


ESL adverse events were mostly of mild and moderate intensities and consistent with previously reported observations for ESL .


ESL treatment was not significantly different from placebo in manic patients in the primary outcome , but secondary outcomes may be suggestive of efficacy .


The recurrence prevention study provides preliminary support for efficacy of ESL in patients recovered from an acute manic episode .


A previously published proof of principle phase IIa trial with 113 patients from Kabul showed that bipolar high-frequency ( HF ) electro-cauterization ( EC ) of cutaneous leishmaniasis ( CL ) ulcers and subsequent moist wound treatment ( MWT ) closed 85 % of all Leishmania ( L. ) tropica lesions within 60days .


A three-armed phase IIb , randomized and controlled clinical trial was performed in Mazar-e-Sharif .


L. tropica - or L. major-infected CL patients received intradermal sodium stibogluconate ( SSG ) ( Group I ) ; HF-EC followed by MWT with 0.045 % DAC N-055 ( Group II ) ; or MWT with 0.045 % DAC N-055 in basic crme alone ( Group III ) .


The primary outcome was complete epithelialisation before day 75 after treatment start .


87 patients enrolled in the trial were randomized into group I ( n = 24 ) , II ( n = 32 ) and III ( n = 31 ) .


The per-protocol analysis of 69 ( 79 % ) patients revealed complete epithelialisation before day 75 in 15 ( of 23 ; 65 % ) patients of Group I , in 23 ( of 23 ; 100 % ) patients of Group II , and in 20 ( of 23 ; 87 % ) patients of Group III ( p = 0.004 , Fisher 's Exact Test ) .


In the per-protocol analysis , wound closure times were significantly different between all regimens in a pair-wise comparison ( p = 0.000039 , Log-Rank ( Mantel-Cox ) test ) .


In the intention-to-treat analysis wound survival times in Group II were significantly different from those in Group I ( p = 0.000040 , Log-Rank ( Mantel-Cox ) test ) .


Re-ulcerations occurred in four ( 17 % ) , three ( 13 % ) and seven ( 30 % ) patients of Group I , II or III , respectively ( p = 0.312 , Pearson Chi-Square Test ) .


Treatment of CL ulcers with bipolar HF-EC followed by MWT with 0.045 % DAC N-055 or with DAC N-055 alone showed shorter wound closure times than with the standard SSG therapy .


The results merit further exploration in larger trials in the light of our current knowledge of in vitro and in vivo activities of chlorite .


Clinicaltrials.gov ID : NCT00996463 .


Registered : 15th October 2009 .


The primary objective of this prospective controlled study was to investigate the impact of standardized injection-site warming on prandial rapid acting insulin dose and glycemic control when studied under real-world conditions .


All 145 participating patients ( 51 female , 94 male , 13 type 1 and 132 type 2 patients , age : 61.68.4 yrs , HbA1c : 7.190.50 % ) were treated with intensive insulin glargine and short-acting insulin analog therapy .


After a 4week treatment optimization run-in period , patients were randomized to continue therapy for three months without ( control ) or with a local injection-site warming device ( InsuPad * ) .


Observation parameters included HbA1c , insulin dose , frequency of hypoglycemia , body weight and adverse events .


HbA1c improved in both arms until study end ( control group : 6.30.5 % ; injection-site warming device : 6.30.5 % ; both p < 0.001 vs. baseline ) .


To achieve this good control , patients in the control group needed to increase the daily prandial insulin dose by 8.1 % ( from 6631U to 7138U , p < 0.05 ) with stable basal insulin requirements .


Patients who used the injection-site warming device required less prandial insulin ( 7043U to 5534U ; -19 % , p < 0.001 ) and slightly more basal insulin ( +3.9 % ) .


Total daily insulin dose increased in the control group ( +3.7 % ) and decreased with warming device use ( -8.6 % , p < 0.001 ) .


The number of hypoglycemic events ( < 63mg/dL ) during the observation period was higher in the control group ( 6.29.9 / patient vs. injection-site warming device : 3.34.8 / patient , p < 0.05 ) .


Main study limitations can be seen in the open label design reliability of the collected dose information and the very obese patient cohort .


When treating obese patients to target with insulin therapy , use of an injection-site warming device for 3months resulted in a lower frequency of hypoglycemic events and a reduction in prandial insulin analog requirements .


If these results are confirmed in other patient populations , an injection-site warming device may be useful in achieving treatment targets with a safer and more efficient basal bolus therapy in insulin-treated patients with type 1 and type 2 diabetes .


To examine whether an acute bout of active or dynamic hamstring-stretching exercises would reduce the amount of muscle damage observed after a strenuous eccentric task and to determine whether the stretching protocols elicit similar responses .


A randomized controlled clinical trial .


Thirty-six young male students performed 5 min of jogging as a warm-up and were allocated to 1 of 3 groups : 3 min of static active stretching ( SAS ) , 3 min of dynamic active stretching ( DAS ) , or control ( CON ) .


All subjects performed eccentric exercise immediately after stretching .


Heart rate , core temperature , maximal voluntary isometric contraction , passive hip flexion , passive hamstring stiffness ( PHS ) , plasma creatine kinase activity , and myoglobin were recorded at prestretching , at poststretching , and every day after the eccentric exercises for 5 d.


After stretching , the change in hip flexion was significantly higher in the SAS ( 5 ) and DAS ( 10.8 ) groups than in the CON ( -4.1 ) group .


The change in PHS was significantly higher in the DAS ( 5.6 % ) group than in the CON ( -5.7 % ) and SAS ( -6.7 % ) groups .


Furthermore , changes in muscle-damage markers were smaller in the SAS group than in the DAS and CON groups .


Prior active stretching could be useful for attenuating the symptoms of muscle damage after eccentric exercise .


SAS is recommended over DAS as a stretching protocol in terms of strength , hamstring range of motion , and damage markers .


To develop and validate a predictive model for glucose change and risk for new-onset impaired fasting glucose in hypertensive participants following treatment with atenolol or hydrochlorothiazide ( HCTZ ) .


Randomized multicenter clinical trial .


A total of 735 white or African-American men and women with uncomplicated hypertension .


Pharmacogenomic Evaluation of Antihypertensive Responses ( PEAR ) is a randomized clinical trial to assess the genetic and nongenetic predictors of blood pressure response and adverse metabolic effects following treatment with atenolol or HCTZ .


To develop and validate predictive models for glucose change , PEAR participants were randomly divided into a derivation cohort of 367 and a validation cohort of 368 .


Linear and logistic regression modeling were used to build models of drug-associated glucose change and impaired fasting glucose ( IFG ) , respectively , in the derivation cohorts .


These models were then evaluated in the validation cohorts .


For glucose change after atenolol or HCTZ treatment , baseline glucose was a significant ( p < 0.0001 ) predictor , explaining 13 % of the variability in glucose change after atenolol and 12 % of the variability in glucose change after HCTZ .


Baseline glucose was also the strongest and most consistent predictor ( p < 0.0001 ) for development of IFG after atenolol or HCTZ monotherapy .


The area under the receiver operating curve was 0.77 for IFG after atenolol and 0.71 after HCTZ treatment , respectively .


Baseline glucose is the primary predictor of atenolol or HCTZ-associated glucose increase and development of IFG after treatment with either drug .


To compare the benefits of a thermal cure and non-thermal rehabilitation in treatment of knee osteoarthritis ( KOA ) .


Randomized therapeutic trial including patients with knee osteoarthritis ( American College of Rheumatology criteria ) .


Patients were randomly divided into two groups .


Spa treatment consisted of underwater shower , massage-jet showers , hydromassage , pool rehabilitation and peloid therapy .


Non-thermal rehabilitation consisted of analgesic physiotherapy , muscle strengthening and group physical rehabilitation .


A blinded evaluation was carried out at day 21 and 12months following treatment .


It was based on the visual analogic scale of pain ( VAS ) , which represented the primary endpoint .


Two hundred and forty patients were included ( February-June 2005 ) .


The spa treatment and non-thermal rehabilitation groups included 119 and 121patients respectively .


Two hundred and thirty-three patients completed their treatments .


Significant improvement of the visual analogic scale of pain was noted in the thermal cure group ( 61.615 at day 0 versus 46.522.4 at 12months , P < 0.001 ) , but not in the non-thermal group ( 64.115 at day 0 versus 6229 at 12months , P = 0.68 ) .


At day 21 , comparison of the two groups revealed no significant difference on the VAS ( P = 0.08 ) .


However , at 12months , the thermal cure group was significantly more improved ( P = 0.000 ) .


In our study , crenobalneotherapy had resulted , at 12months , in more pronounced long-term improvement of the painful symptoms of KOA than had non-thermal rehabilitation .


To assess the effects of maintenance therapy with aripiprazole once-monthly 400mg on personal and social functioning .


Data were analyzed from 2 randomized , double-blind trials of patients with schizophrenia requiring chronic antipsychotic treatment .


One study was a 52-week trial of aripiprazole once-monthly 400mg versus placebo ; the other was a 38-week trial of aripiprazole once-monthly 400mg , oral aripiprazole ( 10-30 mg daily ) , and aripiprazole once-monthly 50mg ( subtherapeutic dose to test assay sensitivity ) .


Functioning was assessed using the Personal and Social Performance ( PSP ) scale , comprising 4 domain subscales .


In the 52-week study , 403 patients stabilized on aripiprazole once-monthly 400mg were randomized to receive aripiprazole once-monthly 400mg ( n = 269 ) or placebo ( n = 134 ) .


In the 38-week study , 662 patients stabilized on oral aripiprazole were randomized to receive aripiprazole once-monthly 400mg ( n = 265 ) , oral aripiprazole ( n = 266 ) , or aripiprazole once-monthly 50mg ( subtherapeutic dose ; n = 131 ) .


In the 52-week study , mean changes from baseline were significantly worsened with placebo compared with aripiprazole once-monthly 400mg for PSP total score ( P < 0.001 ) and domain scores for Personal and Social Relationships ( P < 0.001 ) , Self-Care ( P < 0.01 ) , and Disturbing and Aggressive Behavior ( P < 0.0001 ) .


In the 38-week study , mean changes from baseline were significantly worsened with aripiprazole once-monthly 50mg compared with aripiprazole once-monthly 400mg for PSP total score ( P < 0.05 ) and the Personal and Social Relationships domain score ( P < 0.05 ) .


Patient functioning , assessed using the PSP scale , was maintained in stabilized patients treated with aripiprazole once-monthly in 2 pivotal relapse studies .


To ( 1 ) determine diabetes patients ' acceptance of Internet-based interventions ( IBIs ) for depression , to ( 2 ) examine the effectiveness of an acceptance facilitating intervention ( AFI ) and to ( 3 ) explore subgroup specific effects .


141 diabetes patients from two inpatient rehabilitation units and one outpatient clinic in Germany were randomly allocated to an intervention ( IG ) and a no-intervention control group ( CG ) .


The IG received an AFI consisting of a personal information session before filling-out a questionnaire on patients ' acceptance of IBIs , predictors of acceptance ( performance expectancy , effort expectancy , social influence , facilitating conditions , and Internet anxiety ) as well as sociodemographic , depression-related and diabetes-related variables .


The CG filled out the questionnaire immediately .


Patients ' acceptance of IBIs was measured with a four-item scale ( sum-score ranging from 4 to 20 ) .


The CG showed a low ( 50.7 % ) to medium ( 40.8 % ) acceptance with only 8.5 % of all diabetes patients reporting a high acceptance of IBIs for depression .


The AFI had no significant effect on acceptance ( IG : M = 10.55 , SD = 4.69 , n = 70 ; KG : M = 9.65 , SD = 4.27 , n = 71 ; d = 0.20 [ 95 % - CI : -0.13 ; 0.53 ] ) and the predictors of acceptance .


Yet , subgroup analyses yielded a trend for depressed , diabetes-related distressed , female and younger ( < 59 ) participants and for those who do not frequently use the Internet to profit from the AFI .


Diabetes patients show a rather low acceptance toward IBIs for depression .


Findings indicate that the AFI is likely to be effective in the subgroup of depressed , diabetes-related distressed , female or younger diabetes patients , but not in the whole target population .


Hence , AFIs might need to be tailored to the specific needs of subpopulations .


To compare the use of ropivacaine versus bupivacaine for 3-in-1 block during total knee arthroplasty ( TKA ) in terms of efficacy and safety ( lack of toxicity ) .


14 men and 26 women aged 58 to 77 ( median , 70 ) years who had the American Society of Anesthesiologists ( ASA ) grades I to III physical status were randomised to receive ropivacaine ( n = 20 ) or bupivacaine ( n = 20 ) of a concentration of 0.5 % for 3-in-1 block during TKA .


The dosage was 0.5 ml/kg .


In addition , a sciatic nerve block ( 20 ml of prilocaine 1 % ) was used .


The onset of the block , duration of postoperative analgesia , level of motor block , and any side-effects were compared .


The median time to onset of block was significantly shorter in those receiving ropivacaine than bupivacaine ( 13 vs. 17.5 minutes , p < 0.001 ) , but the levels of motor blockade were not significantly different ( p = 0.355 ) .


Complete analgesia was achieved throughout the procedure .


There was no significant difference between the ropivacaine and bupivacaine groups in terms of the mean duration of analgesia ( 398 vs. 367 minutes , p = 0.62 ) , the mean VAS scores at all time points , and the mean total morphine consumption .


One patient in the ropivacaine group developed a joint haematoma and 2 patients in the bupivacaine group had excessive wound drainage .


Both conditions resolved after antibiotic use .


Ropivacaine and bupivacaine showed similar anesthetic and analgesic effects , but the former had a significantly faster onset time .


Many of the approximately 15 million people with a migration background living in Germany ( 19 % of the population ) are inadequately reached by existing healthcare provision .


In the literature , the necessity for cultural adaptation of information material for patients with a migration background is often cited as a measure for improving healthcare.In this study , culturally sensitive information material will be developed and evaluated for patients with a migration background and depression or chronic low back pain .


In this respect , it will be examined whether culturally sensitive information material is judged as more useful by the patients than standard translated patient information without cultural adaptation .


The implementation and evaluation of culturally sensitive patient information material will occur in the framework of a double-blind randomized controlled parallel-group study in four study centres in Germany .


Primary care patients with a Turkish , Polish , Russian or Italian migration background with a diagnosis of depressive disorder or chronic low back pain will be included and randomly allocated to the intervention group or the control group .


In the intervention group , culturally sensitive patient information will be handed to the patient at the end of the physician consultation , while in the control group , standard translated patient information material will be provided .


The patients will be surveyed by means of questionnaires following the consultation as well as after 8weeks and 6months .


In addition to the primary outcome ( subjective usefulness ) , several patient - and physician-rated secondary outcomes will be considered .


The study will provide an empirical answer to the question of whether persons with a migration background perceive culturally sensitive patient information material as more useful than translated information material without cultural adaptation .


Deutsches Register Klinischer Studien ( DRKS-ID ) DRKS00004241 and Universal Trial Number ( UTN ) U1111-1135-8043 .


Central sleep apnea is associated with poor prognosis and death in patients with heart failure .


Adaptive servo-ventilation is a therapy that uses a noninvasive ventilator to treat central sleep apnea by delivering servo-controlled inspiratory pressure support on top of expiratory positive airway pressure .


We investigated the effects of adaptive servo-ventilation in patients who had heart failure with reduced ejection fraction and predominantly central sleep apnea .


We randomly assigned 1325 patients with a left ventricular ejection fraction of 45 % or less , an apnea-hypopnea index ( AHI ) of 15 or more events ( occurrences of apnea or hypopnea ) per hour , and a predominance of central events to receive guideline-based medical treatment with adaptive servo-ventilation or guideline-based medical treatment alone ( control ) .


The primary end point in the time-to-event analysis was the first event of death from any cause , lifesaving cardiovascular intervention ( cardiac transplantation , implantation of a ventricular assist device , resuscitation after sudden cardiac arrest , or appropriate lifesaving shock ) , or unplanned hospitalization for worsening heart failure .


In the adaptive servo-ventilation group , the mean AHI at 12 months was 6.6 events per hour .


The incidence of the primary end point did not differ significantly between the adaptive servo-ventilation group and the control group ( 54.1 % and 50.8 % , respectively ; hazard ratio , 1.13 ; 95 % confidence interval [ CI ] , 0.97 to 1.31 ; P = 0.10 ) .


All-cause mortality and cardiovascular mortality were significantly higher in the adaptive servo-ventilation group than in the control group ( hazard ratio for death from any cause , 1.28 ; 95 % CI , 1.06 to 1.55 ; P = 0.01 ; and hazard ratio for cardiovascular death , 1.34 ; 95 % CI , 1.09 to 1.65 ; P = 0.006 ) .


Adaptive servo-ventilation had no significant effect on the primary end point in patients who had heart failure with reduced ejection fraction and predominantly central sleep apnea , but all-cause and cardiovascular mortality were both increased with this therapy .


( Funded by ResMed and others ; SERVE-HF ClinicalTrials.gov number , NCT00733343 . )


To determine if the presence of diabetes autoantibodies predicts the development of diabetes among participants in the Diabetes Prevention Program .


A total of 3050 participants were randomized into three treatment groups : intensive lifestyle intervention , metformin and placebo .


Glutamic acid decarboxylase ( GAD ) 65 autoantibodies and insulinoma-associated-2 autoantibodies were measured at baseline and participants were followed for 3.2 years for the development of diabetes .


The overall prevalence of GAD autoantibodies was 4.0 % , and it varied across racial/ethnic groups from 2.4 % among Asian-Pacific Islanders to 7.0 % among non-Hispanic black people .


There were no significant differences in BMI or metabolic variables ( glucose , insulin , HbA ( 1c ) , estimated insulin resistance , corrected insulin response ) stratified by baseline GAD antibody status .


GAD autoantibody positivity did not predict diabetes overall ( adjusted hazard ratio 0.98 ; 95 % CI 0.56-1 .73 ) or in any of the three treatment groups .


Insulinoma-associated-2 autoantibodies were positive in only one participant ( 0.033 % ) .


These data suggest that ` diabetes autoimmunity ' , as reflected by GAD antibodies and insulinoma-associated-2 autoantibodies , in middle-aged individuals at risk for diabetes is not a clinically relevant risk factor for progression to diabetes .


A high dietary protein ( P ) content and low glycemic index ( LGI ) have been suggested to be beneficial for weight management , but long-term studies are scarce .


The DIOGENES randomized clinical trial investigated the effect of P and GI on weight loss maintenance in overweight or obese adults in eight centers across Europe .


This study reports the 1-year results in two of the centers that extended the intervention to 1 year .


After an 8-week low-calorie diet ( LCD ) , 256 adults ( body mass index > 27kgm ( - ) ( 2 ) ) were randomized to five ad libitum diets for 12 months : high P/LGI ( HP/LGI ) , HP/high GI ( HP/HGI ) , low P/LGI ( LP/LGI ) , LP/HGI and a control diet .


During the first 6 months , foods were provided for free through a shop system and during the whole 12-month period , subjects received guidance by a dietician .


Primary outcome variable was the change in body weight over the 12-month intervention period .


During the LCD period , subjects lost 11.2 ( 10.8 , 12.0 ) kg ( mean ( 95 % confidence interval ( CI ) ) ) .


Average weight regain over the 12-month intervention period was 3.9 ( 95 % CI 3.0-4 .8 ) kg .


Subjects on the HP diets regained less weight than subjects on the LP diets .


The difference in weight regain after 1 year was 2.0 ( 0.4 , 3.6 ) kg ( P = 0.017 ) ( completers analysis , N = 139 ) or 2.8 ( 1.4 , 4.1 ) kg ( P < 0.001 ) ( intention-to-treat analysis , N = 256 ) .


No consistent effect of GI on weight regain was found .


There were no clinically relevant differences in changes in cardiometabolic risk factors among diet groups .


A higher protein content of an ad libitum diet improves weight loss maintenance in overweight and obese adults over 12 months .


To verify the effectiveness of the Cognitive Auditory Evoked Potential-P300 ( CAEP-P300 ) for monitoring the therapeutical evolution of students with developmental dyslexia .


Twenty students diagnosed with developmental dyslexia , of both genders , aged between 8 and 14 years , divided into two randomized groups , one of them submitted to a phonological remediation program associated with reading and writing ( GI ) , and the other one representing the control group ( GII ) , participated in the study .


The groups were paired up , and the individuals were submitted to two evaluations of the CAEP-P300 and the same interval was kept for both .


Paired Student 's t-test , ANOVA test , and Pearson 's correlation coefficient were used , adopting 5 % significance level .


The statistical comparison of the pre and post evaluations of each group demonstrated difference in the Phonological Awareness Test ( p = 0.000 ) and in the P300 latency ( p = 0.005 ) only for GI .


CAEP-P300 use for monitoring the therapeutical evolution of children with developmental dyslexia is possible and represents a viable option for intervention programs .


The aim of this study was to evaluate the effectiveness of punctal occlusion using hypromellose 2 % in patients with dry eye .


In this prospective , randomized single-blinded clinical trial , we evaluated 76 eyes of 38 patients ( 36 women and 2 men ) with dry eye secondary to rheumatic diseases .


In each patient , the lower lacrimal punctum of 1 eye was occluded using hypromellose 2 % , whereas the contralateral eye underwent a simulation of the procedure ( control group ) .


Patients ' eyes were assessed for burning , itching , redness , foreign body sensation , and tearing based on a visual scale questionnaire ( score , 0-10 ) .


We also performed objective tests for evaluation of dry eye using a Schirmer test with anesthesia ( basal tear secretion test ) , the tear film break-up time test , and fluorescein and rose bengal staining tests at 0 , 28 , and 56 days after treatment .


Fluorescein and rose bengal staining tests showed that there was a significant reduction in signs after occlusion using hypromellose .


The symptoms measured by the visual scale were significantly reduced .


The values of the Schirmer test with anesthesia and the break-up time test increased significantly .


The effects persisted for up to 8 weeks .


There were no dropouts or reported side effects during the 24-month follow-up .


Our results suggest that punctal occlusion using hypromellose 2 % is a low-cost and safe additional treatment for dry eye .


Systemic inflammation plays an important role in the initiation , promotion , and progression of lung carcinogenesis .


In patients with non-small cell lung cancer ( NSCLC ) , fibrinogen levels correlate with neoplasia .


Here we compared the effects of pulmonary rehabilitation ( PR ) with chest physical therapy ( CPT ) on fibrinogen and albumin levels in patients with LC and previous inflammatory lung disease awaiting lung resection .


We conducted a randomized clinical trial with 24 patients who were randomly assigned to Pulmonary Rehabilitation ( PR ) and Chest Physical Therapy ( CPT ) groups .


Each group underwent training 5 days weekly for 4 weeks .


All patients were assessed before and after four weeks of training through clinical assessment , measurement of fibrinogen and albumin levels , spirometry , 6-minute Walk Test ( 6MWT ) , quality of life survey , and anxiety and depression scale .


PR involved strength and endurance training , and CPT involved lung expansion techniques .


Both groups attended educational classes .


A mixed between-within subjects analysis of variance ( ANOVA ) revealed a significant interaction between time ( before and after intervention ) and group ( PR vs. CPT ) on fibrinogen levels ( F ( 1 , 22 ) = 0.57 , p < 0.0001 ) and a significant main effect of time ( F ( 1 , 22 ) = 0.68 , p = 0.004 ) .


Changes in albumin levels were not statistically significant relative to the interaction effect between time and group ( F ( 1 , 22 ) = 0.96 , p = 0.37 ) nor the main effects of time ( F ( 1 , 22 ) = 1.00 , p = 1.00 ) and group ( F ( 1 , 22 ) = 0.59 , p = 0.45 ) .


A mixed between-within subjects ANOVA revealed significant interaction effects between time and group for the peak work rate of the unsupported upper limb exercise ( F ( 1 , 22 ) = 0.77 , p = 0.02 ) , endurance time ( F ( 1 , 22 ) = 0.60 , p = 0.001 ) , levels of anxiety ( F ( 1 , 22 ) = 0.60 , p = 0.002 ) and depression ( F ( 1 , 22 ) = 0.74 , p = 0.02 ) , and the SF-36 physical component summary ( F ( 1 , 22 ) = 0.83 , p = 0.07 ) .


PR reduced serum fibrinogen levels , improved functional parameters , and quality of life of patients with LC and inflammatory lung disease awaiting lung resection .


Current Controlled Trials RBR-3nm5bv .


The EXAMINE trial showed non-inferiority of the DPP-4 inhibitor alogliptin to placebo on major adverse cardiac event ( MACE ) rates in patients with type 2 diabetes and recent acute coronary syndromes .


Concerns about excessive rates of in-hospital heart failure in another DPP-4 inhibitor trial have been reported .


We therefore assessed hospital admission for heart failure in the EXAMINE trial .


Patients with type 2 diabetes and an acute coronary syndrome event in the previous 15-90 days were randomly assigned alogliptin or placebo plus standard treatment for diabetes and cardiovascular disease prevention .


The prespecified exploratory extended MACE endpoint was all-cause mortality , non-fatal myocardial infarction , non-fatal stroke , urgent revascularisation due to unstable angina , and hospital admission for heart failure .


The post-hoc analyses were of cardiovascular death and hospital admission for heart failure , assessed by history of heart failure and brain natriuretic peptide ( BNP ) concentration at baseline .


We also assessed changes in N-terminal pro-BNP ( NT-pro-BNP ) from baseline to 6 months .


This study is registered with ClinicalTrials.gov , number NCT00968708 .


5380 patients were assigned to alogliptin ( n = 2701 ) or placebo ( n = 2679 ) and followed up for a median of 533 days ( IQR 280-751 ) .


The exploratory extended MACE endpoint was seen in 433 ( 160 % ) patients assigned to alogliptin and in 441 ( 165 % ) assigned to placebo ( hazard ratio [ HR ] 098 , 95 % CI 086-112 ) .


Hospital admission for heart failure was the first event in 85 ( 31 % ) patients taking alogliptin compared with 79 ( 29 % ) taking placebo ( HR 107 , 95 % CI 079-146 ) .


Alogliptin had no effect on composite events of cardiovascular death and hospital admission for heart failure in the post hoc analysis ( HR 100 , 95 % CI 082-121 ) and results did not differ by baseline BNP concentration .


NT-pro-BNP concentrations decreased significantly and similarly in the two groups .


In patients with type 2 diabetes and recent acute coronary syndromes , alogliptin did not increase the risk of heart failure outcomes .


Takeda Development Center Americas .


Umeclidinium bromide ( UMEC ) is an inhaled long-acting muscarinic antagonist in development for chronic obstructive pulmonary disease ( COPD ) .


This was a multicentre , randomised , double-blind , placebo-controlled , three-way cross-over , incomplete block study to evaluate UMEC 15.6 , 31.25 , 62.5 , and 125 g administered once daily ( QD ) , and UMEC 15.6 g and 31.25 g administered twice daily ( BID ) , over 7 days in patients with COPD .


Tiotropium was included as an open-label treatment arm .


The primary efficacy endpoint was trough forced expiratory volume in 1 second ( FEV1 ) on Day 8 .


Secondary efficacy endpoints included weighted mean FEV1 over 0-24 hours after morning dosing on Day 7 , and serial FEV1 at each time point over 24 hours after morning dosing on Day 7 .


Safety and pharmacokinetics were also examined .


One hundred and sixty-three patients ( mean age 59.5 years , 52 % female ) were randomised .


Based on the population dose-response model of trough FEV1 data , the geometric mean potency ( ED50 ) of UMEC was 37 g ( 95 % confidence interval [ CI ] : 18 , 57 ) with a predicted maximum intrinsic efficacy ( Emax ) at trough of 0.185 L ( 95 % CI : 0.153 , 0.218 ) after QD dosing .


UMEC 125 g QD demonstrated the greatest improvements in measure of lung function compared with doses of 62.5 g and below .


UMEC 125 g QD exhibited more consistent increases in FEV1 from baseline across serial time points over 24 hours compared with other UMEC doses and tiotropium .


Increases in FEV1 over 0-12 hours were similar to those observed over 12-24 hours after the second dose of UMEC was administered .


UMEC was rapidly absorbed following inhaled dosing and eliminated from plasma .


Adverse events , generally mild , were highest with UMEC 125 g QD ( 18 % ) compared with placebo ( 8 % ) , tiotropium ( 4 % ) and other UMEC doses ( 5-12 % ) .


UMEC is a potent QD bronchodilator with geometric mean ED50 of 37 g.


A dose ordering over the range of UMEC 15.6-125 g QD doses was observed , with UMEC 125 g showing the greatest improvement in trough FEV1 .


Non-adherence with antipsychotic medication is a frequently occurring problem , particularly among patients with psychotic disorders .


Prior research has generally shown encouraging results for interventions based on ` Contingency Management ' ( CM ) , in which desirable behaviour is encouraged by providing rewards contingent upon the behaviour .


However , little is known about the application of CM on medication adherence in patients with psychotic disorders .


An earlier pilot-study by our study group showed promising results in reducing admission days and increasing adherence .


The current study is a randomized controlled trial concerning the effectiveness of a CM procedure called ` Money for Medication ' ( M4M ) , aimed at improving adherence with antipsychotic depot medication in psychotic disorder patients .


Outpatients ( n = 168 ) with a psychotic disorder will be randomly assigned to either the experimental group ( n = 84 ) , receiving a financial reward for each accepted antipsychotic medication depot , or the control group ( n = 84 ) , receiving treatment as usual without financial rewards .


Patients are included regardless of their previous adherence .


The intervention has a duration of twelve months .


During the subsequent six months follow-up , the effects of discontinuing the intervention on depot acceptance will be assessed .


The primary goal of this study is to assess the effectiveness of providing financial incentives for improving adherence with antipsychotic depot medication ( during and after the intervention ) .


The primary outcome measure is the percentage of accepted depots in comparison to prescription .


Secondary , we will consider alternative measures of medication acceptance , i.e. the longest period of uninterrupted depot acceptance and the time expired before depot is taken .


Additionally , the effectiveness of the experimental intervention will be assessed in terms of psychosocial functioning , substance use , medication side-effects , quality of life , motivation , cost-utility and patients ' and clinicians ' attitudes towards M4M .


This RCT assesses the effectiveness and side-effects of financial incentives in improving adherence with antipsychotic depot medication in patients with psychotic disorders .


This study is designed to assess whether M4M is an effective intervention to improve patients ' acceptance of their antipsychotic depot medication and to examine how this intervention contributes to patients ' functioning and wellbeing .


NTR2350 .


Percutaneous coronary interventions are almost always preceded by the loading dose of platelets inhibiter drugs such as clopidogrel or prasugrel and followed by maintenance therapy to decrease the mortality and morbidity due to stent thrombosis .


This study was conducted to compare the efficacy of clopidogrel and prasugrel for inhibiting platelet aggregation among patients undergoing elective percutaneous coronary intervention .


This randomized controlled trial study was done in Department of Cardiology , Postgraduate Medical Institute Govt .


Lady Reading Hospital Peshawar .


A total of 148 patients were randomly allocated to either group-A containing 74 patients using clopidogrel or group-B containing 74 patients using prasugrel


Group-A had 55 ( 74.3 % ) male and 19 ( 25.7 % ) females while group-B had 56 ( 75.7 % ) males and 18 ( 24.3 % ) females ( p = 0.85 ) .


Mean age was 54.9 + / - 11.2 years in group-A and was 57.7 + / - 8.7 years in group-B ( p = 0.09 ) .


Mean body weight was 71.8 ?


6.4 Kg in group-A and 70.8 + / - 6.3 Kg in group-B ( p = 0.35 ) .


Mean Baseline platelet aggregation before drug administration was 10.43 + / - 1.9 ohm in group-A while 10.12 + / - 2.2 ohm in group-B ( p = 0.36 ) .


Mean Follow up platelet aggregation 6 hours after drug administration was 5.88 + / - 2.9 in group-A while it was 3.47 + / - 1.8 ohm in group-B ( p = 0.001 ) .


Mean Difference between basal and follow up platelet aggregation + / - SD was 52.9649 + / - 24.77 in group-A while it was 82.25 + / - 14.34 in group-B ( p = 0.001 ) .


63 ( 85.15 % ) of group-A had inhibition of platelets aggregation > 10 % as compare to 72 ( 97.3 % ) of group-B had inhibition of platelets aggregation > 10 % ( p = 0.009 ) .


Prasugrel is more efficacious than clopidogrel in term of inhibition of platelets aggregation .


Short-segment U-shaped pedicle screw fixation has been widely used to treat thoracolumbar burst fracture .


Some studies have reported the disadvantages of traditional U-shaped pedicle screw , which included a relatively high rate of adjacent segment degeneration and screw failure , including screw pullout and breakage .


The purpose of this study was to assess the efficacy of open reduction and fixation using KumaFix fixation system in treatment of thoracolumbar burst fractures .


From June 2011 to June 2012 , 45 consecutive patients with thoracolumbar burst fractures were enrolled .


They were randomly assigned to treatment with KumaFix ( the treatment group , n = 23 ) or traditional U-shaped pedicle screw ( the control group , n = 22 ) .


The patients were followed up postoperatively and were assessed with regard to radiologic and clinical outcomes .


Radiologic outcomes were assessed mainly on the basis of Cobb angle and vertebral wedge angle .


Clinical outcomes were evaluated mainly with use of Visual Analog Scale ( VAS ) for pain and the Oswestry Disability Index ( ODI ) Questionnaire .


All patients were followed up from 9 to 22 months .


There were no significant differences between the two groups with regard to preoperative indices .


The operation time in the treatment group was significantly lower than that in the control group .


Preoperative Cobb angles and vertebral wedge angles in two groups were significantly decreased after surgery , and these have been well maintained at the last follow-up with mild correction losses .


The results of clinical outcome showed lower VAS and ODI scores in two groups compared with those preoperative , and the treatment group had greater improvement on the ODI compared with the control group at the last follow-up .


Compared with traditional U-shaped pedicle screw , KumaFix fixation system can achieve gradual , controlled reduction , provide enough space for bone implantation , and avoid acceleration of adjacent segment degeneration .


It is an effective and reliable technique to treat thoracolumbar burst fractures .


Educating emergency medical staffs in triage skills is an important aspect of disaster preparedness .


The aim of the study was to compare the effect of role-playing and educational video presentation on the learning and performance of the emergency medical service staffs in Khozestan , Iran


A total of 144 emergency technicians were randomly classified into two groups .


A researcher trained the first group using an educational video method and the second group with a role-playing method .


Data were collected before , immediately , and 15 days after training using a questionnaire covering the three domains of demographic information , triage knowledge , and triage performance .


The data were analyzed using defined knowledge and performance parameters .


There was no significant difference between the two training methods on performance and immediate knowledge ( P = .2 ) , lasting knowledge ( P = .05 ) and immediate performance ( P = .35 ) , but there was a statistical advantage for the role-playing method on lasting performance ( P = .02 ) .


The two educational methods equally increase knowledge and performance , but the role-playing method may have a more desirable and lasting effect on performance .


This study evaluated preferences for shared decision making with respect to mental health treatment in a sample of veterans who were diagnosed as having serious mental illness .


Participants were 239 outpatients receiving care from the Department of Veterans Affairs who completed self-report questionnaires assessing demographic factors , shared decision-making preferences , psychiatric symptom severity , and the therapeutic relationship with their second-generation antipsychotic prescribers ( N = 21 ) .


Preferences were assessed in regard to three components of decision making : knowledge about mental illness , options about mental health treatment , and decisions about mental health care .


Most participants ( 85 % ) indicated that they preferred to be offered options and to be asked their opinions about mental health treatment .


More variability was noted in preferences for obtaining knowledge and making final treatment decisions ; 61 % preferred to rely on their providers ' knowledge and 64 % preferred their provider to make treatment final decisions .


Greater preferences for participation in shared decision making were found among African American clients , those currently working for pay , those with college or higher education , those with other than a schizophrenia spectrum diagnosis , and those who reported a poorer therapeutic relationship with their prescribers .


The degree to which veterans with serious mental illness desired to participate in their mental health care differed in terms of the aspect of care and across demographic and clinical factors .


A thorough assessment of shared decision-making preferences is an important component of recovery-oriented , client-centered care .


To examine the imaging-detected mechanism of reduction of structural joint damage progression by tocilizumab ( TCZ ) in patients with rheumatoid arthritis ( RA ) using MRI .


In a substudy of a randomised , double-blind , phase 3b study ( ACT-RAY ) of biologic-nave patients with RA who were methotrexate ( MTX ) - inadequate responders , 63 patients were randomised to continue MTX or receive placebo ( PBO ) , both in combination with TCZ 8 mg/kg every 4 weeks , with optional additional disease-modifying antirheumatic drugs at week 24 if Disease Activity Score of 28 joints < 3.2 .


The most symptomatic hand was imaged with 0.2 Tesla extremity MRI at weeks 0 , 2 , 12 and 52 .


MR images were scored using Outcome Measures in Rheumatology-Rheumatoid Arthritis Magnetic Resonance Imaging Score .


Predictors of week 52 erosion progression were determined by logistic regression analysis .


TCZ + PBO ( n = 32 ) demonstrated mean improvements in synovitis from baseline to weeks 2 ( -0.92 ; p = 0.0011 ) , 12 ( -1.86 ; p < 0.0001 ) and 52 ( -3.35 ; p < 0.0001 ) , while TCZ + MTX ( n = 31 ) had mean improvements in synovitis at week 12 ( -0.88 ; p = 0.0074 ) , but not week 52 ( -1.00 ; p = 0.0711 ) .


TCZ+PBO demonstrated mean reductions in osteitis at weeks 12 ( -5.10 ; p = 0.0022 ) and 52 ( -8.56 ; p = 0.0006 ) , while TCZ+MTX had mean reductions at weeks 2 ( -0.21 ; p < 0.05 ) and 12 ( -3.63 ; p = 0.0008 ) , but not week 52 ( -2.31 ; p = 0.9749 ) .


Mean erosion scores did not worsen in either group .