The treatment effect of serelaxin was most pronounced on other CV deaths ( hazard ratio [ HR ] : 0.29 ; 95 % CI : 0.12 to 0.73 ; p = 0.005 ) and sudden death ( HR : 0.46 ; 95 % CI : 0.20 to 1.07 ; p = 0.065 ) .


There was no apparent impact of serelaxin treatment on HF deaths or non-CV deaths .


In the RELAX-AHF study , the effects of serelaxin on mortality were primarily driven by reduction in mortality from other CV causes and sudden death , without apparent impact on HF deaths .


( Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure [ RELAX-AHF ] ; NCT00520806 ) .


Aerosol immunization may be a useful tool to reach and sustain the elimination of measles , rubella , and congenital rubella syndrome .


We compared booster seroresponses to aerosolized or injected MMR vaccines containing different strains of measles ( Attenuvax or Edmonston-Zagreb ) and mumps ( Jeryl-Lynn or Leningrad-Zagreb ) .


To assess the safety and immunogenicity of two MMR : Vaccines administered by aerosol .


A randomized and controlled clinical trial was conducted to evaluate the safety and booster responses to the MMR SII ( Serum Institute of India ) and MMR II ( Merck Sharp & Dhome ) vaccines , both of which were administered by aerosol ( ae ) or injection ( inj ) to Mexican children aged 6-7 years in elementary schools .


The seroresponses were evaluated by PRN ( measles ) and ELISA ( rubella and mumps ) .


Adverse events were followed-up for 28 days after the immunization .


Two hundred and fifty-three of 260 children completed the one-month follow-up .


All participants reached protective seropositivity for measles and rubella after immunization , and 98.3 to 100 % reached protective seropositivity for mumps ( p = 0.552 ) .


The proportions of the seroresponses ( a 2-fold rise from the baseline antibody titers ) to measles were 38.3 % for MMR SII ( ae ) , 31.3 % for MMR II ( ae ) , 37.5 % for MMR SII ( inj ) , and 44.6 % for MMR II ( inj ) ( p = 0.483 ) .


The seroresponses for rubella were 26.7 % for MMR SII ( ae ) , 31.3 % for MMR II ( ae ) , 46.9 % for MMR SII ( inj ) , and 40.0 % for MMR II ( inj ) ( p = 0.086 ) .


The seroresponse to mumps were 31.7 % for MMR SII ( ae ) , 25.0 % for MMR II ( ae ) , 48.4 % for MMR SII ( inj ) , and 53.9 % for MMR II ( inj ) ( p = 0.002 ) .


The difference in the seroresponse of a 4-fold rise from the baseline antibody titers was not statistically significant .


Only mild adverse events were noted .


Aerosolized vaccines were as safe and as immunogenic as injected vaccines .


CMN 2010-005 ( National Regulatory Authority ) .


We evaluated the efficacy and safety of S-1 plus oxaliplatin ( SOX ) as an alternative to cisplatin plus S-1 ( CS ) in first-line chemotherapy for advanced gastric cancer ( AGC ) .


In this randomized , open-label , multicenter phase III study , patients were randomly assigned to receive SOX ( 80-120 mg/day S-1 for 2 weeks with 100 mg/m ( 2 ) oxaliplatin on day 1 , every 3 weeks ) or CS ( S-1 for 3 weeks with 60 mg/m ( 2 ) cisplatin on day 8 , every 5 weeks ) .


The primary end points were noninferiority in progression-free survival ( PFS ) and relative efficacy in overall survival ( OS ) for SOX using adjusted hazard ratios ( HRs ) with stratification factors ; performance status and unresectable or recurrent ( + adjuvant chemotherapy ) disease .


Overall , 685 patients were randomized from January 2010 to October 2011 .


In per-protocol population , SOX ( n = 318 ) was noninferior to CS ( n = 324 ) in PFS [ median , 5.5 versus 5.4 months ; HR 1.004 , 95 % confidence interval ( CI ) 0.840-1 .199 ; predefined noninferiority margin 1.30 ] .


The median OS for SOX and CS were 14.1 and 13.1 months , respectively ( HR 0.958 with 95 % CI 0.803-1 .142 ) .


In the intention-to-treat population ( SOX , n = 339 ; CS , n = 337 ) , the HRs in PFS and OS were 0.979 ( 95 % CI 0.821-1 .167 ) and 0.934 ( 95 % CI 0.786-1 .108 ) , respectively .


The most common grade 3 adverse events ( SOX versus CS ) were neutropenia ( 19.5 % versus 41.8 % ) , anemia ( 15.1 % versus 32.5 % ) , hyponatremia ( 4.4 % versus 13.4 % ) , febrile neutropenia ( 0.9 % versus 6.9 % ) , and sensory neuropathy ( 4.7 % versus 0 % ) .


SOX is as effective as CS for AGC with favorable safety profile , therefore SOX can replace CS .


JapicCTI-101021 .


To assess the differences in clinical outcome between complex patients treated with Resolute zotarolimus-eluting stents ( ZES ) versus Xience V everolimus-eluting stents ( EES ) .


Nowadays , many complex patients with coronary disease are treated with percutaneous coronary interventions , using drug-eluting stents ( DES ) .


We analyzed 2-year outcome data of 1,033 complex patients of the TWENTE trial , treated with second-generation Resolute ZES or Xience V EES .


Complex patients had at least one of the following characteristics : renal insufficiency ( creatinine140 mol/l ) ; ejection fraction < 30 % ; acute myocardial infarction ( MI ) within previous 72 hrs ; > 1 lesion/vessel ; > 2 vessels treated ; lesion length > 27 mm ; bifurcation ; saphenous vein graft lesion ; arterial bypass graft lesion ; in-stent restenosis ; unprotected left main lesion ; lesion with thrombus ; or lesion with total occlusion .


Target vessel failure ( TVF ) , the primary composite endpoint of the trial , was defined as cardiac death , target vessel-related MI , or target vessel revascularization .


Among the 1,033 complex patients , 529 ( 51 % ) were treated with Resolute ZES and 504 ( 49 % ) with Xience V EES .


Patient - and procedure-related characteristics were similar between DES groups .


After 2-year follow-up , outcome was also similar between DES groups .


TVF occurred in 12.1 % of patients treated with Resolute ZES and 12.3 % of patients treated with Xience V EES .


In addition , DES groups did not differ significantly in cardiac death , MI , or target vessel revascularization-the individual components of TVF .


Complex patients treated with Resolute ZES and Xience V EES showed similar safety and efficacy during 2-year follow-up .


2014 Wiley Periodicals , Inc. .


The aim of this study was to compare the use of multilayer amniotic membrane transplantation ( AMT ) with lamellar corneal transplantation ( LCT ) and lamellar scleral transplantation ( LST ) for the treatment of scleral thinning after pterygium surgery associated with beta therapy .


Twenty-six eyes from 26 different patients with scleral thinning as a consequence of beta therapy after pterygium surgery were evaluated at the Federal University of So Paulo , Brazil .


Ophthalmologic examination and ultrasound biomicroscopy were performed to assess scleral thinning before the transplant surgery and then repeated at 30 , 90 , and 180 days after surgery .


An increase in scleral thickness , epithelialization of the ocular surface , and preservation of the ocular globe were the main outcome measures .


Irrespective of the surgical technique used ( AMT , LCT , or LST ) , no clinical or statistical changes in corrected distance visual acuity were found in any of the patients during this study .


The median preoperative scleral thickness was similar in all 3 groups : AMT = 0.45 mm , LST = 0.48 mm , and LCT = 0.52 mm ( P = 0.257 ) ; however , 6 months after surgery , the median thickness in the AMT group ( 0.19 ) was significantly less than that of the LCT group ( 0.57 ) ( P = 0.27 ) or the LST group ( 0.76 ) ( P = 0.19 ) .


Epithelialization occurred in all the patients .


LCT was the best option for the structural treatment of scleral thinning , followed by LST with a conjunctival flap .


A high rate of reabsorption was found with AMT , which was the least effective of the 3 therapeutic options and should not be used for this condition .


Agility is a determinant component in soccer performance .


This study aimed to evaluate the reliability and sensitivity of a `` Modified Illinois change of direction test '' ( MICODT ) in ninety-five U-14 soccer players .


A total of 95 U-14 soccer players ( mean SD : age : 13.61 1.04 years ; body mass : 30.52 4.54 kg ; height : 1.57 0.1 m ) from a professional and semi-professional soccer academy , participated to this study .


Sixty of them took part in reliability analysis and thirty-two in sensitivity analysis .


The intraclass correlation coefficient ( ICC ) that aims to assess relative reliability of the MICODT was of 0.99 , and its standard error of measurement ( SEM ) for absolute reliability was < 5 % ( 1.24 % ) .


The MICODT 's capacity to detect change is `` good '' , it 's SEM ( 0.10 s ) was SWC ( 0.33 s ) .


The MICODT is significantly correlated to the Illinois change of direction speed test ( ICODT ) ( r = 0.77 ; p < 0.0001 ) .


The ICODT 's MDC95 ( 0.64 s ) was twice about the MICODT 's MDC95 ( 0.28 s ) , indicating that MICODT presents better ability to detect true changes than ICODT .


The MICODT provided good sensitivity since elite U-14 soccer players were better than non-elite one on MICODT ( p = 0.005 ; dz = 1.01 [ large ] ) .


This was supported by an area under the ROC curve of 0.77 ( CI 95 % , 0.59 to 0.89 , p < 0.0008 ) .


The difference observed in these two groups in ICODT was not statistically significant ( p = 0.14 ; dz = 0.51 [ small ] ) , showing poor discriminant ability .


MICODT can be considered as more suitable protocol for assessing agility performance level than ICODT in U-14 soccer players .


Perioperative management with reduced-dose warfarin is of potential interest by eliminating the need for bridging while still maintaining a degree of anticoagulation .


The outcomes of this regimen have not been well determined .


In a randomized controlled trial we compared two regimens for management of anticoagulation with warfarin in patients with implantation of a pacemaker or defibrillator .


Half dose of warfarin for 3-6 days , depending on the baseline international normalized ratio ( INR ) , before surgery aiming at an INR of 1.7 was compared with interrupted warfarin for 5 days with preoperative bridging with low-molecular-weight heparin ( LMWH ) at therapeutic dose for 2.5 days .


Main safety outcome was pocket hematoma .


Secondary outcomes were major bleeding , thromboembolism - all within 1 month , days of hospitalization and number of patients requiring correction of INR with vitamin K.


The study was planned for 450 patients but it was discontinued prematurely due to a change in practice .


Pocket hematoma occurred in 4 of 85 patients ( 5 % ) randomized to the bridged regimen and in 3 of 86 patients ( 3 % ) randomized to reduced-dose warfarin .


One pocket hematoma in each group was severe .


There were no major hemorrhages or thromboembolism within the 1-month window .


Duration of hospitalization was similar in the two groups .


Correction of INR the day before surgery with vitamin K had to be used for significantly more patients in the reduced-dose warfarin group ( 41 % ) than in the bridged regimen group ( 6 % ) .


The reduced-dose warfarin regimen appeared to have similar safety after device implantation as interrupted warfarin with preoperative LMWH bridging .


Due to premature discontinuation no firm conclusion can be drawn .


The reduced-dose warfarin regimen often failed to achieve the intended preoperative INR .


ClinicalTrials.gov Identifier : NCT 02094157 .


This study introduces a method to calculate myocardium blood flow ( MBF ) and coronary flow reserve ( CFR ) using the relatively low-dose dynamic 320-row multi-detector computed tomography ( MDCT ) , validates the method against ( 15 ) O-HO positron-emission tomography ( PET ) and assesses the CFRs of coronary artery disease ( CAD ) patients .


Thirty-two subjects underwent both dynamic CT perfusion ( CTP ) and PET perfusion imaging at rest and during pharmacological stress .


In 12 normal subjects ( pilot group ) , the calculation method for MBF and CFR was established .


In the other 13 normal subjects ( validation group ) , MBF and CFR obtained by dynamic CTP and PET were compared .


Finally , the CFRs obtained by dynamic CTP and PET were compared between the validation group and CAD patients ( n = 7 ) .


Correlation between MBF of MDCT and PET was strong ( r = 0.95 , P < 0.0001 ) .


CFR showed good correlation between dynamic CTP and PET ( r = 0.67 , P = 0.0126 ) .


CFRCT in the CAD group ( 2.30.8 ) was significantly lower than that in the validation group ( 5.21.8 ) ( P = 0.0011 ) .


We established a method for measuring MBF and CFR with the relatively low-dose dynamic MDCT .


Lower CFR was well demonstrated in CAD patients by dynamic CTP .


MBF and CFR can be calculated using dynamic CTP with 320-row MDCT .


MBF and CFR showed good correlation between dynamic CTP and PET .


The presence of depressive subsyndromal symptoms ( SS ) in bipolar disorder ( BD ) increases the risk of affective relapse and worsens social , cognitive functioning , and quality of life .


Nonetheless , there are limited data on how to optimize the treatment of subthreshold depressive symptoms in BD .


Mindfulness-Based Cognitive Therapy ( MBCT ) is a psychotherapeutic intervention that has been shown effective in unipolar depression .


The assessment of its clinical effectiveness and its impact on biomarkers in bipolar disorder patients with subsyndromal depressive symptoms and psychopharmacological treatment is needed .


A randomized , multicenter , prospective , versus active comparator , evaluator-blinded clinical trial is proposed .


Patients with BD and subclinical or mild depressive symptoms will be randomly allocated to : 1 ) MBCT added to psychopharmacological treatment ; 2 ) a brief structured group psychoeducational intervention added to psychopharmacological treatment ; 3 ) standard clinical management , including psychopharmacological treatment .


Assessments will be conducted at screening , baseline , post-intervention ( 8 weeks ) and 4 month follow-up post-intervention .


The aim is to compare MBCT intervention versus a brief structured group psychoeducation .


Our hypothesis is that MBCT will be more effective in reducing the subsyndromal depressive symptoms and will improve cognitive performance to a higher degree than the psychoeducational treatment .


It is also hypothesized that a significant increase of BDNF levels will be found after the MBCT intervention .


This is the first randomized controlled trial to evaluate the effects of MBCT compared to an active control group on depressive subthreshold depressive symptoms in patients with bipolar disorder .


ClinicalTrials.gov : NCT02133170 .


Registered 04/30/2014 .


Residual inhibition ( RI ) is the temporary inhibition of tinnitus by use of masking stimuli when the device is turned off .


The main aim of this study was to evaluate the effects of RI induced by auditory electrical stimulation ( AES ) in the primary auditory pathways using early auditory-evoked potentials ( AEPs ) in subjective idiopathic tinnitus ( SIT ) subjects .


A randomized placebo-controlled study was conducted on forty-four tinnitus subjects .


All enrolled subjects based on the responses to AES , were divided into two groups of RI and Non-RI ( NRI ) .


The results of the electrocochleography ( ECochG ) , auditory brain stem response ( ABR ) and brain stem transmission time ( BTT ) were determined and compared pre - and post-AES in the studied groups .


The mean differences in the compound action potential ( CAP ) amplitudes and III/V and I/V amplitude ratios were significantly different between the RI , NRI and PES controls .


BTT was significantly decreased associated with RI .


The observed changes in AEP associated with RI suggested some peripheral and central auditory alterations .


Synchronized discharges of the auditory nerve fibers and inhibition of the abnormal activity of the cochlear nerve by AES may play important roles associated with RI .


Further comprehensive studies are required to determine the mechanisms of RI more precisely .


In sub-Saharan Africa , malaria continues to cause over 10,000 maternal deaths and 75,000 to 200,000 infant deaths .


Successful control of malaria in pregnancy could save lives of mothers and babies and is an essential part of antenatal care in endemic areas .


The primary objective is to determine the protective efficacy of community-scheduled screening and treatment ( CSST ) using community health workers ( CHW ) against the primary outcome of prevalence of placental malaria .


The secondary objectives are to determine the protective efficacy of CSST on maternal anaemia , maternal peripheral infection , low birth weight , selection of sulfadoxine-pyrimethamine ( SP ) resistance markers , and on antenatal clinic ( ANC ) attendance and coverage of intermittent preventive treatment during pregnancy ( IPTp-SP ) .


This is a multi-centre cluster-randomised controlled trial involving three countries with varying malaria endemicity ; low ( The Gambia ) versus high transmission ( Burkina Faso and Benin ) , and varying degrees of SP resistance ( high in Benin and moderate in Gambia and Burkina Faso ) .


CHW and their related catchment population who are randomised into the intervention arm will receive specific training on community-based case management of malaria in pregnancy .


All women in both study arms will be enrolled at their first ANC visits in their second trimester where they will receive their first dose of IPTp-SP .


Thereafter , CHW in the intervention arm will perform scheduled monthly screening and treatment in the womens homes .


At time of delivery , a placental biopsy will be collected from all women to determine placental malaria .


At each contact point , filter paper and blood slides will be collected for detection of malaria infection and SP resistance markers .


To reach successful global malaria control , there is an urgent need to access those at greatest risk of malaria infection .


The project is designed to develop a low-cost intervention in pregnant women which will have an immediate impact on the malaria burden in resource-limited countries .


This will be done by adding to the standard IPTp-SP delivered through the health facilities : an `` extension '' strategy to the communities in rural areas thus bringing health services closer to where women live .


Current Controlled Trials : ISRCTN37259296 ( 5 July 2013 ) , and clinicaltrials.gov : NCT01941264 ( 10 September 2013 ) .


We studied the combined effects of wholegrain , fish and bilberries on serum metabolic profile and lipid transfer protein activities in subjects with the metabolic syndrome .


Altogether 131 subjects ( 40-70 y , BMI 26-39 kg/m ( 2 ) ) with impaired glucose metabolism and features of the metabolic syndrome were randomized into three groups with 12-week periods according to a parallel study design .


They consumed either : a ) wholegrain and low postprandial insulin response grain products , fatty fish 3 times a week , and bilberries 3 portions per day ( HealthyDiet ) , b ) wholegrain and low postprandial insulin response grain products ( WGED ) , or c ) refined wheat breads as cereal products ( Control ) .


Altogether 106 subjects completed the study .


Serum metabolic profile was studied using an NMR-based platform providing information on lipoprotein subclasses and lipids as well as low-molecular-weight metabolites .


There were no significant differences in clinical characteristics between the groups at baseline or at the end of the intervention .


Mixed model analyses revealed significant changes in lipid metabolites in the HealthyDiet group during the intervention compared to the Control group .


All changes reflected increased polyunsaturation in plasma fatty acids , especially in n-3 PUFAs , while n-6 and n-7 fatty acids decreased .


According to tertiles of changes in fish intake , a greater increase of fish intake was associated with increased concentration of large HDL particles , larger average diameter of HDL particles , and increased concentrations of large HDL lipid components , even though total levels of HDL cholesterol remained stable .


The results suggest that consumption of diet rich in whole grain , bilberries and especially fatty fish causes changes in HDL particles shifting their subclass distribution toward larger particles .


These changes may be related to known protective functions of HDL such as reverse cholesterol transport and could partly explain the known protective effects of fish consumption against atherosclerosis .


The study was registered at ClinicalTrials.gov NCT00573781 .


Ciclosporin is approved for the treatment of atopic dermatitis ( AD ) in dogs and has been shown to be safe and effective .


Placebo-controlled studies suggest that oclacitinib is a safe and effective alternative therapy .


To evaluate the efficacy and safety of oclacitinib , in comparison to ciclosporin , for the control of AD in a blinded , randomized clinical trial , incorporating a noninferiority test at day 28 .


A total of 226 client-owned dogs with a history of AD from eight sites were enrolled .


Enrolled animals were randomized to receive oral oclacitinib ( 0.4-0 .6 mg/kg twice daily for 14 days , then once daily ) or oral ciclosporin ( 3.2-6 .6 mg/kg once daily ) for 12 weeks .


Owners assessed pruritus using an enhanced visual analog scale ( VAS ) , and veterinarians assessed dermatitis using the Canine Atopic Dermatitis Extent and Severity Index ( CADESI ) -02 .


On days 1 , 2 , 7 , 14 , 28 , 56 and 84 , the percentage reduction from baseline for owner-assessed pruritus changed from 25.6 to 61.0 % in the oclacitinib group compared with 6.5 to 61.5 % in the ciclosporin group ; differences were significant at all time points up to day 28 .


On day 56 , ciclosporin-treated dogs showed a similar decrease in pruritus to oclacitinib-treated dogs .


On day 14 , the percentage reduction from baseline CADESI-02 was significantly greater in the oclacitinib group ( 58.7 % ) than in the ciclosporin group ( 43.0 % ) .


Three times as many adverse events attributed to gastrointestinal signs were reported in the ciclosporin group compared with the oclacitinib group .


In this study of treatment for canine AD , oclacitinib had a faster onset of action and a lower frequency of gastrointestinal side effects compared with ciclosporin .


The purpose of this randomized , controlled clinical trial was to compare the effectiveness of a new treatment approach , which consisted of laterally positioned flap ( LPF ) procedure combined with an external vestibular releasing incision made by a diode laser ( LALPF ) to LPF alone for the treatment of isolated gingival recession defects .


Thirty-two healthy patients presenting single Miller class II isolated gingival recessions with minimal loss of interdental papilla were treated with an LPF technique .


Sixteen patients were randomly assigned to the test group ( laser-assisted laterally positioned flap [ LALPF ] ) , and the other 16 patients were assigned to the control group ( LPF ) .


In the test group , diode laser was used for vestibular deepening in order to obtain maximum maneuverability of the advanced flap .


Clinical and patient-centered parameters ( visual analog scale for pain and aesthetics [ VAS ] ) were measured at baseline , 7 days , and 6 months after the surgery .


Complete root coverage from baseline to 6 months post-surgery was achieved for 46.7 % of the control group and 81.2 % of the test group ( p = 0.044 ) .


There were no differences in VAS pain measurements between the groups .


Patient satisfaction with aesthetics was higher in LALPF group than in the LPF group .


Six month results showed that the LALPF approach was effective for the treatment of single Miller class II gingival recessions .


To evaluate the analgesic efficacy of oral premedication of oxycodone in a group of patients undergoing elective uterine artery embolization under sedation for fibroid disease .


Thirty-nine patients ( mean age 42.3 years ) were prospectively randomized 1:1 to receive 20 mg oxycodone or placebo orally immediately before their procedure .


At the commencement of the procedure , patients were provided with a patient-controlled analgesia device for 24 h , programmed to deliver 1 mg boluses of intravenous morphine with a 5 min lockout .


Mean visual analog scale pain intensity ratings ( 0-100 mm ) were measured from both groups and evaluated over 0 to 6 h as the primary end point .


Other measured parameters included opioid-related side effects and eligibility for discharge ( NCT00163930 ; September 12 , 2005 ) .


Early pain intensity did not vary significantly between the active and placebo groups [ mean ( standard deviation ) : 3.2 ( 2.5 ) vs. 3.1 ( 2.2 ) , p = 0.89 ] .


The oxycodone group , however , experienced significantly more nausea ( p = 0.035 ) and a greater incidence of vomiting ( p = 0.044 ) .


Overall opioid requirement over 24 h , measured as oral morphine equivalent , was greater in the oxycodone group ( median [ interquartile range ] : 64.5 [ 45-90 ] mg vs. 22.5 [ 15-46 .5 ] mg , p < 0.0001 ) .


The number of patients first eligible for discharge at 24 h in the oxycodone group was decreased but not significantly ( p = 0.07 ) .


The addition of preprocedural oral oxycodone to morphine patient-controlled analgesia does not offer any analgesic advantage to patients having uterine artery embolization and may cause a greater incidence of nausea and vomiting .


In light of the high prevalence of sleep disorders in patients suffering from posttraumatic stress disorder ( PTSD ) , this study sought to compare the effect of prazosin and hydroxyzine on sleep quality in this patient group .


A total of 100 patients suffering from PTSD were assessed ( mean age = 35.51 years , SD = 6.41 ; 28 % females ) .


Next , they were randomly assigned to one of three treatment groups : prazosin ( 33 patients ) , hydroxyzine ( 34 patients ) or placebo ( 33 patients ) .


The trial lasted for 8 weeks .


The patients ' sleep quality was assessed using the Pittsburgh Sleep Quality Index .


Items taken from the Mini International Neuropsychiatric Interview were used to operationalize PTSD .


Compared to controls , patients treated with prazosin and hydroxyzine reported improved sleep and less nightmares .


Improvement was greatest in patients treated with prazosin compared to hydroxyzine and placebo .


Improvement in sleep was associated with an amelioration of their PTSD symptoms .


Both prazosin and hydroxyzine can be used to treat psychopharmacological sleep disorders and nightmares in patients suffering from PTSD , also leading to reductions in PTSD symptoms .


Reinfarction after primary percutaneous coronary intervention in patients with ST-segment-elevation myocardial infarction has negative consequences .


Little is known about reinfarction after drug-eluting stents and bivalirudin anticoagulation .


We , therefore , sought to determine the incidence , predictors , and implications of reinfarction after primary percutaneous coronary intervention in the contemporary era .


Outcomes were assessed in 3202 patients undergoing stent implantation for ST-segment-elevation myocardial infarction in the Harmonizing Outcomes with RevascularIZatiON and Stents in Acute Myocardial Infarction ( HORIZONS-AMI ) trial .


Independent predictors of reinfarction and mortality were identified by Cox proportional hazards modeling .


The cumulative incidence of reinfarction was 1.8 % at 30 days , 4.0 % at 1 year , and 6.9 % at 3 years .


Definite stent thrombosis was responsible for 76.3 % of reinfarctions occurring within 30 days and 52.0 % of all reinfarctions within 3 years .


Independent predictors of reinfarction were current smoking , Killip class 2 , baseline thrombocytosis , multivessel disease , symptom onset-to-balloon time , and total stent length .


Randomization to bivalirudin versus heparin plus a glycoprotein IIb/IIIa inhibitor and use of drug-eluting versus bare metal stents were not significant predictors of reinfarction .


Reinfarction was a powerful independent predictor of subsequent cardiac mortality ( hazard ratio [ 95 % confidence interval ] = 7.65 [ 4.47-13 .09 ] ; P < 0.0001 ) and all-cause mortality ( hazard ratio [ 95 % confidence interval ] = 2.88 [ 1.74-4 .78 ] ; P < 0.0001 ) .


Despite advances in pharmacotherapy and stents , reinfarction after primary percutaneous coronary intervention is not infrequent , in the contemporary era is most often attributable to stent thrombosis , and is strongly associated with subsequent cardiac and all-cause mortality .


Further enhancements in drugs and devices to prevent reinfarction are needed to improve outcomes in high-risk patients with ST-segment-elevation myocardial infarction .


http://www.clinicaltrials.gov .


Unique identifier : NCT00433966 .


The aim of this study was to evaluate the efficacy of alternating etoposide-cisplatin and vinorelbine-cisplatin ( EP-NP ) compared with an etoposide-cisplatin ( EP ) regimen for advanced combined small cell carcinomas .


Histologically confirmed combined small cell carcinoma patients who met the inclusion criteria were randomly assigned ( 1:1 ) into either the EP-NP setting ( group A ) or the EP setting ( group B ) .


The primary endpoint was progression-free survival in patients who received at least one dose of treatment .


Eighty-two patients entered into this trial , 42 in group A and 40 in group B.


The objective response rates in group A and group B were 42.9 % and 32.5 % , respectively ( p = 0.334 ) .


Survival analysis showed that median progression-free survival was 6.1 months in group A , which was significantly longer than the 4.1 months in group B ( p = 0.041 ) .


However , as to overall survival , no significant difference was found between the two groups ( 11.0 vs 10.1 months in groups A and B , respectively , p = 0.545 ) .


No unexpected side effects were observed in either group .


The EP-NP regimen for combined small cell carcinomas prolonged progression - free survival compared with the EP regimen .


Further clinical investigations are warranted .


Limited evidence exists regarding the long-term effects of community health worker-led diabetes management programs on health outcomes and cost-effectiveness , particularly in low-income , ethnic minority populations .


To examine the long-term cost-effectiveness and improvements in diabetes-related complications of a diabetes education and management intervention led by community health workers among uninsured Mexican Americans .


Clinical data , changes in hemoglobin A1c over 12 months , and costs from an RCT of 180 uninsured Mexican Americans with type 2 diabetes conducted in 2006 were utilized for secondary analyses in 2012 .


Simulation modeling was used to estimate long-term cost and health outcomes using the validated Archimedes Model .


The absolute differences for the incremental cost-effectiveness ratios and cumulative incidence of diabetes-related complications were derived by comparing intervention and control groups .


During a 20-year time horizon , participants who received the intervention would be expected to have significantly lower hemoglobin A1c levels ( p < 0.001 ) , fewer foot ulcers ( p < 0.001 ) , and a reduced number of foot amputations ( p = 0.005 ) in comparison with a control group receiving usual medical care .


An incremental cost-effectiveness ratio of $ 355 per quality-adjusted life year gained was estimated for intervention participants during the same time period .


A simulated clinical trial suggests that a community health worker-led diabetes intervention is a cost-effective way to reduce diabetes-related complications for uninsured Mexican Americans during a 20-year horizon in comparison to usual medical care .


We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study ( ACUARP ) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain .


The study is designed as a randomised controlled pilot trial with three arms and partial double blinding .


We will compare ( a ) press needle acupuncture , ( b ) no treatment and ( c ) press plaster acupressure in a standardised anaesthetic setting .


Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms .


The total observation period will begin one day before surgery and end on the second postoperative day .


Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points .


The primary outcome measure will be time from extubation to ` ready for discharge ' from the post anaesthesia care unit ( in minutes ) .


The ` ready for discharge ' end point will be assessed using three different scores : the Aldrete score , the Post Anaesthetic Discharge Scoring System and an In-House score .


Secondary outcome measures will comprise pre - , intra - and postoperative variables ( which are anxiety , pain , nausea and vomiting , concomitant medication ) .


The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery .


Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques .


NCT01816386 ( First received : 28 October 2012 ) .


A startling loud acoustic stimulus can involuntarily elicit planned movements , a phenomenon referred to as startReact .


Following stroke , startReact elbow flexion in stroke survivors are improved from voluntary movements .


Specifically , startReact elbow flexion in unimpaired individuals is not statistically different from stroke survivors in terms of onset latency and muscle activation patterns .


As hand movements are particularly impacted by stroke , our objective was to determine if startReact was intact in the hand following stroke .


Data were collected in 8 stroke survivors and 10 age-matched subjects performing hand extension following two non-startling acoustic stimuli representing `` get ready '' and `` go '' respectively .


Randomly , the `` go '' was replaced with a startling acoustic stimulus .


We hypothesized that ( 1 ) startReact would be intact during hand extension in stroke survivors and that ( 2 ) the latency of movement would be the same as in age-matched subjects .


We found that startReact was intact in stroke subjects and further that the onset latency of these movements was not different from age-matched subjects .


We conclude that startReact is intact in the hand following stroke .


An intact startReact response indicates that this reflex may be an attractive therapeutic target for initiating hand extension in stroke survivors .


One of the most challenging aspects of a revision knee arthroplasty is the management of bone loss .


The OBJECTIVE of the study is to show the capability to augment bone mineral density in areas with bone loss with platelet-derived growth factors .


Randomized , prospective , blinded study in patients who underwent a total knee replacement revision with tibial-damaged metaphyseal bone were randomly allocated to have a revision total knee arthroplasty and to fill the bone defects with lyophilized bone allograft mixed with platelet growth factors ( experimental group , n = 9 ) or with lyophilized bone allograft alone ( control group , n = 7 ) .


To evaluate bone mineral density between groups , dual-energy X-ray absorptiometry ( DEXA ) was performed preoperatively , at 1 month , 6 months and 1 year after surgery .


The study was comprised of a total of 16 patients .


We found no significant differences observed during the follow-up between groups in mineral bone density .


Use of platelet-derived growth factors does not improve bone mineral density in patients with revision knee arthroplasty .


The greater presence of supermarkets in low-income , high-minority neighborhoods has the potential to positively affect diet quality among those at greatest risk of obesity .


In-store marketing strategies that draw attention to healthier products may be effective , sustainable , and scalable for improving diet quality and health .


Few controlled studies of in-store marketing strategies to promote sales of healthier items in low-income , high-minority neighborhoods have been conducted .


The objective of this study was to evaluate the effects of in-store marketing strategies to promote the purchase of specific healthier items in 5 product categories : milk , ready-to-eat cereal , frozen meals , in-aisle beverages , and checkout cooler beverages .


The design was a cluster-randomized controlled trial conducted from 2011 to 2012 .


Eight urban supermarkets in low-income , high-minority neighborhoods were the unit of randomization , intervention , and analysis .


Stores were matched on the percentage of sales from government food-assistance programs and store size and randomly assigned to an intervention or control group .


The 4 intervention stores received a 6-mo , in-store marketing intervention that promoted the sales of healthier products through placement , signage , and product availability strategies .


The 4 control stores received no intervention and were assessment-only controls .


The main outcome measure was weekly sales of the targeted products , which was assessed on the basis of the stores ' sales data .


Intervention stores showed significantly greater sales of skim and 1 % milk , water ( in aisle and at checkout ) , and 2 of 3 types of frozen meals compared with control store sales during the same time period .


No differences were found between the stores in sales of cereal , whole or 2 % milk , beverages , or diet beverages .


These data indicate that straightforward placement strategies can significantly enhance the sales of healthier items in several food and beverage categories .


Such strategies show promise for significant public health effects in communities with the greatest risk of obesity .


This study examined the association between cardiac autonomic dysfunction and high albumin-to-creatinine ratio ( ACR ) in adolescents with type 1 diabetes .


Adolescents recruited as part of a multicenter screening study ( n = 445 , 49 % female , aged 10-17 years , mean duration 6.9 years ; mean HbA1c 8.4 % , 68 mmol/mol ) underwent a 10-min continuous electrocardiogram recording for heart rate variability analysis .


Time-domain heart rate variability measures included baseline heart rate , SD of the R-R interval ( SDNN ) , and root mean squared difference of successive R-R intervals ( RMSSD ) .


Spectral analysis included sympathetic ( low-frequency ) and parasympathetic ( high-frequency ) components .


Standardized ACR were calculated from six early morning urine collections using an established algorithm , reflecting age , sex , and duration , and stratified into ACR tertiles , where the upper tertile reflects higher nephropathy risk .


The upper-tertile ACR group had a faster heart rate ( 76 vs. 73 bpm ; P < 0.01 ) and less heart rate variability ( SDNN 68 vs. 76 ms , P = 0.02 ; RMSSD 63 vs. 71 ms , P = 0.04 ) .


HbA1c was 8.5 % ( 69 mmol/mmol ) in the upper tertile vs. 8.3 % ( 67 mmol/mol ) in the lower tertiles ( P = 0.07 ) .


In multivariable analysis , upper-tertile ACR was associated with faster heart rate ( = 2.5 , 95 % CI 0.2-4 .8 , P = 0.03 ) and lower RMSSD ( = -9.5 , 95 % CI -18.2 to -0.8 , P = 0.03 ) , independent of age and HbA1c .


Adolescents at potentially higher risk for nephropathy show an adverse cardiac autonomic profile , indicating sympathetic overdrive , compared with the lower-risk group .


Longitudinal follow-up of this cohort will further characterize the relationship between autonomic and renal dysfunction and the effect of interventions in this population .


According to mathematical modeling , intradialytic exercise of sufficient intensity and duration implemented in the second half of dialysis should be as efficacious as increasing dialysis time for dialysis adequacy .


This assumption has not been tested in vivo .


In this controlled trial , 11 hemodialysis ( HD ) patients ( mean ( SD ) age 56 ( 13 ) years ) were recruited .


Each patient completed three trial arms in a randomized order : routine care ( CONT ) , increased HD time of 30 min ( TIME ) , and intradialytic exercise ( EXER ) , 60 min of cycling at 90 % of the lactate threshold in the last 90 min of HD .


The primary outcome was eKt/Vurea .


Secondary outcomes included reduction and rebound ratios of urea , creatinine , phosphate and 2-microglobulin .


Outcomes were calculated from blood sampling collected pre - , post - and 30 min post-HD and confirmed with dialysate sampling .


Exercise was not as efficacious as increased HD time for eKt/Vurea ( EXER vs. CONT , mean change ( 95 % CI ) : 0.03 ( -0.05 to 0.12 ) ; TIME vs. CONT : 0.15 ( 0.05-0 .26 ) ) .


Exercise was less efficacious at improving reduction ratios of urea and creatinine .


However , exercise was more efficacious than increased dialysis time for phosphate reduction ratio ( EXER vs. CONT : 8.6 % ( 0.5-16 .7 ) ; TIME vs. CONT : 5.0 % ( -1.0 to 11.1 ) ) .


This study utilized a rigorously controlled in vivo design to test mathematical models and assumptions regarding dialysis adequacy .


Intradialytic exercise towards the end of HD can not replace the prescription of increased HD time for dialysis adequacy , but may be an adjunctive therapy for serum phosphate control .


Previous observational studies examining outcomes associated with the timing of dialysis therapy initiation in the United States have often been limited by lead time and survivor bias .


Retrospective cohort study comparing the effectiveness of early versus later ( conventional ) dialysis therapy initiation in advanced chronic kidney disease ( CKD ) .


The analysis used inverse probability weighting to account for an individual 's contribution to different exposure groups over time in a pooled logistic regression model .


Patients contributed risk to both exposure categories ( early and later initiation ) until there was a clear treatment strategy ( ie , dialysis therapy was initiated early or estimated glomerular filtration rate [ eGFR ] decreased to < 10mL/min/1 .73 m ( 2 ) ) .


Patients with CKD who had at least one face-to-face outpatient encounter with a Cleveland Clinic health care provider as of January 1 , 2005 , and at least 3 eGFRs in the range of 20-30mL / min/1 .73 m ( 2 ) measured at least 180 days apart .


Timing of dialysis therapy initiation as determined using model-based interpolation of eGFR trajectories over time .


Timing was defined as early ( interpolated eGFR at dialysis therapy initiation10mL/min/1 .73 m ( 2 ) ) or later ( eGFR < 10mL/min/1 .73 m ( 2 ) ) and was time-varying .


Death from any cause occurring from the time that eGFR was equal to 20mL/min/1 .73 m ( 2 ) through September 15 , 2009 .


The study population consisted of 652 patients meeting inclusion criteria .


Most ( 71.3 % ) of the study population did not initiate dialysis therapy during follow-up .


Patients who did not initiate dialysis therapy ( n = 465 ) were older , more likely to be white , and had more favorable laboratory profiles than those who started dialysis therapy .


Overall , 146 initiated dialysis early and 80 had eGFRs decrease to < 10mL/min/1 .73 m ( 2 ) .


Many participants ( n = 426 ) were censored prior to attaining a clear treatment strategy and were considered undeclared .


There was no statistically significant survival difference for the early compared with later initiation strategy ( OR , 0.85 ; 95 % CI , 0.65-1 .11 ) .


Interpolated eGFR , moderate sample size , and likely unmeasured confounders .


In patients with advanced CKD , timing of dialysis therapy initiation was not associated with mortality when accounting for lead time bias and survivor bias .


Bianchi and Squire introduced single high trans-scrotal incision for mobilisation of palpable undescended testes to decrease the potential morbidity of the traditional inguinal approach .


This incision has not gained widespread acceptance and there is still a considerable debate about its efficacy .


This study evaluated the outcome of high single scrotal incision in comparison to the classic inguinal exploration for unilateral palpable testes regardless to its pre-operative location to assure its validity and safety .


This was a randomised controlled study conducted on seventy males with palpable unilateral undescended testicles from November 2009 to October 2013 .


They were divided into two equal groups ; group I had high single scrotal incision and group II had the classic inguinal approach .


The comparative parameters between both groups were the operative time , intra-and post-operative complications , post-operative pain and scar .


There was statistical significant difference between both groups regarding the operative time ( P < 0.001 ) .


The high scrotal approach ( Group I ) was not completed in three cases and were converted to the classic inguinal approach .


No statistical significant difference between both groups regarding the post-operative complications .


Single high scrotal incision orchidopexy for palpable undescended testis is safe , has shorter operative time but may not be suitable for proximally lying testis .


Intravitreal antiangiogenic therapy is the major therapeutic breakthrough in neovascular age-related macular degeneration ( AMD ) .


Optical coherence tomography ( OCT ) is the leading diagnostic tool , but solid criteria for optimal therapeutic outcomes are lacking .


A comprehensive analysis of structure/function correlations using Food and Drug Administration - and European Medicines Agency-approved substances and fixed and flexible regimens was performed .


Post hoc analysis of a prospective , randomized multicenter clinical trial including 189 study sites .


A total of 1240 patients with active neovascular AMD .


Participants received intravitreal ranibizumab or aflibercept .


A fixed regimen was used for 48 weeks followed by a flexible regimen until week 96 .


At monthly intervals , best-corrected visual acuity ( BCVA ) was measured and retinal morphology was assessed by standardized OCT , including intraretinal cysts ( IRCs ) , subretinal fluid ( SRF ) , and pigment epithelial detachment ( PED ) , presenting with a width 400 m or a height of 200 m. Results were correlated for each regimen , feature , and time .


The BCVA outcomes in relation to retinal pathomorphology based on noninferiority for all treatment arms .


In neovascular AMD , only IRC at baseline and persistent through week 12 had a negative impact on BCVA .


With therapeutic intervention , exudative features such as IRC and SRF resolved rapidly in 74 % of eyes , whereas PED responded only slowly with 38 % .


Independent of the type of regimen , fixed or flexible , retinal morphology correlated tightly with visual function .


Intraretinal cysts consistently showed the lowest BCVA gains with either regimen or substance .


With the switch from a fixed to a flexible pro re nata ( PRN ) regimen , progressive visual loss occurred exclusively in the group with primary PED presenting as the hallmark of neovascular activity and was induced by secondary formation of IRC in the neurosensory retina .


The efficacy of antiangiogenic therapy in neovascular AMD is strongly determined by morphologic features .


The subretinal pigment epithelium lesion underlying PED appears to be the primary indicator for progressive disease activity , whereas secondary cystoid degeneration is the most relevant imaging marker for visual function .


Clinically , PED emerged as trigger for consecutive vision loss in PRN treatment .


The present article presents the protocol for a randomised controlled trial to test the effectiveness of a group-based self-management support programme for recently diagnosed type 2 diabetes mellitus ( T2DM ) patients ( one to three years post-diagnosis ) and their partners .


The course aims to support T2DM patients and their partners in successfully integrating diabetes care into their daily lives and hereby enhance self-management and diabetes-specific health-related quality of life .


The content of the course is based on the Common-Sense Model of Self-Regulation ( CSM ) .


Furthermore , principles from the Social Cognitive Theory ( SCT ) and social support theories are integrated .


We aim to recruit 160 recently diagnosed T2DM patients and their partners from general practices in six different regions in the Netherlands .


Patients need to be diagnosed with T2DM for one to three years and have to experience some degree of diabetes-related difficulties , as measured with a three-item screener .


Participating patients and their partners are randomly allocated to the intervention or control condition .


Participants in the intervention condition receive three monthly group sessions and a booster session three months later .


Participants in the control condition receive a single information meeting .


Data will be collected at baseline ( T0 ) , directly after the programme ( T1 ) and six months post-programme ( T2 ) , including : self-management , diabetes-specific health-related quality of life , illness perceptions , attitudes , social support and empowerment .


A three-level multilevel model will be used to compare change-scores between the conditions ( intervention/control ) on each outcome .


Our study will be the first to determine whether a group-based support programme based on the CSM is effective in enhancing self-management and diabetes-specific health-related quality of life in recently diagnosed T2DM patients .


The important role of patients ' partners in effective diabetes care is also acknowledged in the study .


Netherlands National Trial Register ( NTR ) NTR3302 .


We evaluated an all-oral regimen comprising the nucleotide polymerase inhibitor sofosbuvir ( SOF ) with the NS5A inhibitor ledipasvir ( LDV ) or the NS5B non-nucleoside inhibitor GS-9669 in patients with genotype 1 hepatitis C virus ( HCV ) infection .


A total of 113 patients were enrolled .


Sofosbuvir ( 400 mg once daily ) and LDV ( 90 mg once daily ) plus ribavirin ( RBV ) were given for 12 weeks to treatment-nave ( TN ) patients ( n = 25 ) and those who did not respond to previous therapy ( prior null responders , n = 9 ) .


Sofosbuvir and GS-9669 ( 500 mg once daily ) plus RBV were given for 12 weeks to TN patients ( n = 25 ) and prior null responders ( n = 10 ) .


Additionally , prior null responders with cirrhosis were randomly assigned to groups given a fixed-dose combination of SOF and LDV , with RBV ( n = 9 ) or without RBV ( n = 10 ) .


Finally , a group of TN patients received SOF , LDV , and RBV for 6 weeks ( n = 25 ) .


The primary efficacy end point was sustained virologic response 12 weeks after therapy ( SVR12 ) .


SVR12 was achieved by 25 of 25 ( 100 % ) TN patients receiving SOF , LDV , and RBV and 23 of 25 ( 92 % ) of those receiving SOF , GS-9669 , and RBV .


Of TN patients receiving 6 weeks of SOF , LDV , and RBV , 17 of 25 ( 68 % ) achieved SVR12 .


All noncirrhotic prior null responders receiving 12 weeks of SOF along with another direct-acting antiviral agent plus RBV achieved SVR12-9 of 9 ( 100 % ) of those receiving SOF , LDV , and RBV and 10 of 10 ( 100 % ) of those receiving SOF , GS-9669 , and RBV .


Among cirrhotic prior null responders , SVR12 was achieved by 9 ( 100 % ) of those receiving SOF , LDV , and RBV and 7 ( 70 % ) of those receiving SOF and LDVD without RBV .


The most common reported adverse events were headache , fatigue , and nausea .


The combination of SOF and a second direct-acting antiviral agent is highly effective in TN patients with HCV genotype 1 infection and in patients that did not respond to previous treatment .


ClinicalTrials.gov ID NCT01260350 .


Religious involvement may help individuals with chronic medical illness cope better with physical disability and other life changes .


We examine the relationships between religiosity , depressive symptoms , and positive emotions in persons with major depression and chronic illness .


129 persons who were at least somewhat religious/spiritual were recruited into a clinical trial to evaluate the effectiveness of religious vs. secular cognitive behavioral therapy .


Reported here are the relationships at baseline between religious involvement and depressive symptoms , purpose in life , optimism , generosity , and gratefulness using standard measures .


Although religiosity was unrelated to depressive symptoms ( F = 0.96 , p = 0.43 ) and did not buffer the disability-depression relationship ( B = -1.56 , SE 2.90 , p = 0.59 ) , strong relationships were found between religious indicators and greater purpose , optimism , generosity , and gratefulness ( F = 7.08 , p < 0.0001 ) .


Although unrelated to depressive symptoms in the setting of major depression and chronic medical illness , higher religious involvement is associated with positive emotions , a finding which may influence the course of depression over time .


Sleep and ongoing cycling of sleep states are required for neurosensory processing , learning , and brain plasticity .


Many aspects of neonatal intensive care environments such as handling for routine and invasive procedures , bright lighting , and noise can create stress , disrupt behavior , and interfere with sleep in prematurely born infants .


The study empirically investigated whether a 30-minute observation of infant sleep states and behavior could differentiate an intervention to promote sleep in premature infants with feeding difficulties relative to conventional care ( standard positioning , standard crib mattress [ SP ] ) .


We included an intervention to determine the ability of the method to discriminate treatments and generate a benchmark for future improvements .


The intervention , a conformational positioner ( CP ) , is contoured around the infant to provide customized containment and boundaries .


To more fully verify the 30-minute observational sleep results , standard polysomnography was conducted simultaneously and sleep outcomes for the 2 modalities were compared .


In a randomized crossover clinical trial , 25 infants , 31.5 0.6 weeks ' gestational age and 38.4 0.6 weeks at the study , with gastrointestinal conditions or general feeding difficulties used each intervention during an overnight neonatal intensive care unit sleep study .


Infant sleep states and behaviors were observed during two 30-minute periods -- that is , on the positioner and mattress -- using the naturalistic observation of newborn behavior .


Two certified developmental care nurses assessed sleep state , self-regulatory , and stress behaviors during 2-minute intervals and summed over 30 minutes .


Sleep characteristics from standard polysomnography were measured at the time of behavior observations .


Infants on CP spent significantly less time in alert , active awake , or crying states by observation compared with SP .


Surgical subjects spent more time awake , active awake , or crying and displayed a higher number of behavior state changes than the nonsurgical infants .


The percentage of time in observed deep sleep and quiet sleep was correlated with both percentage sleep efficiency ( r = 0.78 ) and fewer state shifts per hour ( r = -0.65 ) from electroencephalogram ( EEG ) .


Sleep efficiency by EEG was greater on CP versus SP .


The CP enabled sleep compared with the standard mattress ( SP ) over 30-minute observation periods .


Sleep status from behavioral observation was verified by standard EEG-based sleep techniques .


Behavioral observation of sleep states may be a useful strategy for measuring the effectiveness of strategies to facilitate sleep in premature infants .


Surgical subjects may benefit from additional interventions to promote sleep .


Bronchiolitis is a common clinical problem in children below 2 years presenting with respiratory symptoms .


As there is necrosis and sloughing of epithelial cells , edema , increased secretion of mucus causing obstruction of large and small airways we aim to see the clinical profile and the effect of use of hypertonic ( 3 % ) saline nebulization in these children .


A double blind randomized controlled trial was conducted at department of Pediatrics , in a hospital from July 2012 to August 2013 .


The computer generated random number was used to select the case and control group .


All eligible patients were randomly assigned to one of two groups : receiving inhalation of 4 ml normal ( 0.9 % ) saline or hypertonic ( 3 % ) saline .


Treating physicians , researchers and nurses were all blinded of the solution .


Both saline were kept in two identical containers and labeled as solution A and solution B. Patients in each group will receive three treatments on each day of hospitalization and clinical score were obtained 30 minutes before each inhalation session .


Bronchiolitis accounted 11.26 % of total admissions .


Their mean age ( SD ) was 8.56 ( 5.013 ) months with range from 45 days to 24 months .


A total of 53 ( 74 % ) male were enrolled in the study .


Fifty-seven ( 79 % ) children were less than 12 months and 15 ( 21 % ) were 12 months - 24 months .


The mean ( SD ) for duration of hospital stay was 44.82 ( 23.15 ) and 43.60 ( 28.25 ) for 3 % and 0.9 % group respectively ( p = 0.86 ) .


Likewise , mean ( SD ) duration of oxygen supplementation was 32.50 ( 20.44 ) and 34.50 ( 26.03 ) for 3 % and 0.9 % group respectively ( p = 0.85 ) .


Moreover , time required for normalization of clinical score was 36.79 ( 19.53 ) and 38.34 ( 26.67 ) for 3 % and 0.9 % group respectively ( p = 0.80 ) .


There is no advantage of hypertonic saline over normal saline nebulization in the management bronchiolitis .


The IFCT-GFPC 0502 phase III study reported prolongation of progression-free survival with gemcitabine or erlotinib maintenance vs. observation after cisplatin-gemcitabine induction chemotherapy for advanced non-small-cell lung cancer ( NSCLC ) .


This analysis was undertaken to assess the incremental cost-effectiveness ratio ( ICER ) of these strategies for the global population and pre-specified subgroups .


A cost-utility analysis evaluated the ICER of gemcitabine or erlotinib maintenance therapy vs. observation , from randomization until the end of follow-up .


Direct medical costs ( including drugs , hospitalization , follow-up examinations , second-line treatments and palliative care ) were prospectively collected per patient during the trial , until death , from the primary health-insurance provider 's perspective .


Utility data were extracted from literature .


Sensitivity analyses were conducted .


The ICERs for gemcitabine or erlotinib maintenance therapy were respectively 76,625 and 184,733 euros per quality-adjusted life year ( QALY ) .


Gemcitabine continuation maintenance therapy had a favourable ICER in patients with PS = 0 ( 52,213 / QALY ) , in responders to induction chemotherapy ( 64,296 / QALY ) , regardless of histology ( adenocarcinoma , 62,292 / QALY , non adenocarcinoma , 83,291 / QALY ) .


Erlotinib maintenance showed a favourable ICER in patients with PS = 0 ( 94,908 / QALY ) , in patients with adenocarcinoma ( 97,160 / QALY ) and in patient with objective response to induction ( 101,186 / QALY ) , but it is not cost-effective in patients with PS = 1 , in patients with non-adenocarcinoma or with stable disease after induction chemotherapy .


Gemcitabine - or erlotinib-maintenance therapy had ICERs that varied as a function of histology , PS and response to first-line chemotherapy .


Bevacizumab is associated with an increased risk of arterial thromboembolism ( ATE ) ; however , its effect on venous thromboembolism ( VTE ) remains controversial .


Scant data exist on the factors that increase the risk of ATE/VTE in patients with prostate cancer .


The authors investigated the association of bevacizumab treatment and clinical factors with ATE/VTE risk in patients who were treated on Cancer and Leukemia Group B ( CALGB ) trial 90401 .


Patients with metastatic , castration-resistant prostate cancer were randomized to receive docetaxel and prednisone with or without bevacizumab once every 21 days .


Cycle-to-event Cox regression models were used to investigate the association of bevacizumab with the incidence of grade 3 or greater ( 3 ) ATE and VTE .


Age , prior ATE/VTE , baseline antiplatelet/anticoagulant use , and VTE risk score ( based on leukocyte count , hemoglobin , platelet count , body mass index , and tumor location ) were evaluated in univariate and multivariable analyses .


Of 1008 randomized patients , the odds of experiencing grade 3 ATE were significantly greater in those who received bevacizumab compared with those who received placebo ( odds ratio , 2.79 ; P = .02 ) , whereas an opposite trend was noted for grade 3 VTE ( odds ratio , 0.60 ; P = .08 ) .


In the multivariable analysis , bevacizumab treatment ( hazard ratio [ HR ] , 3.00 ; P = .01 ) and age ( HR , 1.06 ; P = .02 ) were significantly associated with the risk of ATE ; whereas age ( HR , 1.05 ; P = .01 ) and VTE risk score ( HR , 1.83 ; P = .03 ) were significantly associated with the risk of VTE .


Bevacizumab was significantly associated with a greater risk of ATE in patients with metastatic , castration-resistant prostate cancer , but it was not significantly associated with the risk of VTE .


Understanding clinical factors that increase the risk for experiencing ATE/VTE is essential to mitigate the risks and reduce the burden of these prevalent complications in cancer care .


Previous studies have reported that stretching of the calf musculature and the plantar fascia are effective management strategies for plantar heel pain ( PHP ) .


However , it is unclear whether myofascial release ( MFR ) can improve the outcomes in this population .


To investigate whether myofascial release ( MFR ) reduces the pain and functional disability associated with plantar heel pain ( PHP ) in comparison with a control group receiving sham ultrasound therapy ( SUST ) .


Randomized , controlled , double blinded trial .


Nonprofit research foundation clinic in India .


Sixty-six patients , 17 men and 49 women with a clinical diagnosis of PHP were randomly assigned into MFR or a control group and given 12 sessions of treatment per client over 4 weeks .


The Foot Function Index ( FFI ) scale was used to assess pain severity and functional disability .


The primary outcome measure was the difference in FFI scale scores between week 1 ( pretest score ) , week 4 ( posttest score ) , and follow-up at week 12 after randomization .


Additionally , pressure pain thresholds ( PPT ) were assessed over the affected gastrocnemii and soleus muscles , and over the calcaneus , by an assessor blinded to the treatment allocation .


The simple main effects analysis showed that the MFR group performed better than the control group in weeks 4 and 12 ( P < 0.001 ) .


Patients in the MFR and control groups reported a 72.4 % and 7.4 % reduction , respectively , in their pain and functional disability in week 4 compared with that in week 1 , which persisted as 60.6 % in the follow-up at week 12 in the MFR group compared to the baseline .


The mixed ANOVA also revealed significant group-by-time interactions for changes in PPT over the gastrocnemii and soleus muscles , and the calcaneus ( P < 0.05 ) .


This study provides evidence that MFR is more effective than a control intervention for PHP .


To evaluate the safety and effectiveness of radiofrequency dissection in conventional ` open ' total thyroidectomy .


Thirty-nine patients scheduled for conventional total thyroidectomy were included in a prospective randomised study .


Patients were randomly assigned to one of two groups : a radiofrequency dissection method was used in one group , and a knot tying technique was used in the other .


Significantly fewer surgical instruments and materials were required for the radiofrequency dissection group than the knot tying group ( p < 0.01 ) .


There were no significant differences between the two groups in mean operative time , blood loss , post-operative drainage and pain , recurrent palsy , and hypocalcaemia ( p > 0.05 ) .


Radiofrequency dissection is a safe alternative to the knot tying technique , and enables a significant reduction in the number of surgical instruments required for the operation .


Lactose intolerance ( LI ) is a common medical problem with limited treatment options .


The primary symptoms are abdominal pain , diarrhea , bloating , flatulence , and cramping .


Limiting dairy foods to reduce symptoms contributes to low calcium intake and the risk for chronic disease .


Adaptation of the colon bacteria to effectively metabolize lactose is a novel and potentially useful approach to improve lactose digestion and tolerance .


RP-G28 is novel galacto-oligosaccharide ( GOS ) being investigated to improve lactose digestion and the symptoms of lactose intolerance in affected patients .


A randomized , double-blind , parallel group , placebo-controlled study was conducted at 2 sites in the United States .


RP-G28 or placebo was administered to 85 patients with LI for 35 days .


Post-treatment , subjects reintroduced dairy into their daily diets and were followed for 30 additional days to evaluate lactose digestion as measured by hydrogen production and symptom improvements via a patient-reported symptom assessment instrument .


Lactose digestion and symptoms of LI trended toward improvement on RP-G28 at the end of treatment and 30 days post-treatment .


A reduction in abdominal pain was also demonstrated in the study results .


Fifty percent of RP-G28 subjects with abdominal pain at baseline reported no abdominal pain at the end of treatment and 30 days post treatment ( p = 0.0190 ) .


RP-G28 subjects were also six times more likely to claim lactose tolerance post-treatment once dairy foods had been re-introduced into their diets ( p = 0.0389 ) .


Efficacy trends and favorable safety/tolerability findings suggest that RP-G28 appears to be a potentially useful approach for improving lactose digestion and LI symptoms .


The concurrent reduction in abdominal pain and improved overall tolerance could be a meaningful benefit to lactose intolerant individuals .


Helicobacter pylori eradication rates with clarithromycin-based triple therapy are declining , and an alternative strategy is needed urgently .


We sought to compare the efficacy of pretreatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy for H. pylori eradication in a region with high rates of multiple drug resistance .


Consecutive H. pylori-infected patients with gastric epithelial neoplasms were randomized to receive antimicrobial susceptibility-guided therapy or clarithromycin-based triple therapy for 7 days .


In patients in whom the infection was not eradicated , antibiotics were given according to an initial antimicrobial susceptibility test as a second-line therapy in both groups .


Eradication rates , antibiotics resistance rates , and drug compliance owing to adverse effects were compared between the groups .


In total , 114 patients were enrolled , and 112 completed the protocols .


Drug compliance and side effects were similar between the groups .


The intention-to-treat eradication rates were 94.7 % ( 95 % confidence interval ( CI ) = 88.8-100 % , 54/57 ) in the antimicrobial susceptibility-guided group and 71.9 % ( 95 % CI = 60.2-83 .5 % , 41/57 ) in the clarithromycin-based triple therapy group after the initial treatment ( P = 0.002 ) , whereas the per-protocol ( PP ) eradication rates were 96.4 % ( 95 % CI = 91.5-100 % , 54/56 ) in the antimicrobial susceptibility-guided group and 73.2 % ( 95 % CI = 61.5-84 .8 % , 41/56 ) in the clarithromycin-based triple therapy group ( P = 0.001 ) .


In H. pylori with clarithromycin resistance , the eradication failure rate with first-line treatment was lower in the susceptibility-guided therapy group ( 0 % , 0/12 ) compared with the clarithromycin-based triple therapy group ( 80.0 % , 95 % CI = 59.7-100 % , 12/15 ) by PP analysis ( P < 0.001 ) .


Pretreatment antimicrobial susceptibility-guided therapy is more effective than clarithromycin-based triple therapy for H. pylori eradication in a region with high rates of multiple drug resistance .


Persons with a mental health diagnosis have high rates of tobacco use and face numerous barriers to cessation including high levels of nicotine dependence , low rates of tobacco treatment referrals from mental health providers , and limited availability of tobacco treatment targeted to their needs .


This manuscript describes the rationale and methods of a clinical trial with the following aims : 1 ) Compare the reach and efficacy of a proactive telephone-based tobacco cessation program for Veterans Health Administration ( VHA ) mental health clinic patients to VHA usual care and 2 ) Model longitudinal associations between baseline patient characteristics and long-term abstinence .


We will use the electronic medical record to identify patients across four VHA healthcare facilities who have a clinical reminder code indicating current tobacco use in the past six months and who have had a mental health clinic visit in the past 12 months .


We will send each patient an introductory letter and baseline survey .


Survey respondents ( N = 3840 ) will be randomized in a 1:1 fashion to intervention or control .


Control participants will receive VHA usual care .


Intervention participants will receive proactive motivational telephone outreach to offer tobacco treatment .


Intervention participants interested in treatment will receive eight weeks of nicotine replacement therapy plus eight sessions of specialized telephone counseling over two months , followed by monthly maintenance counseling for four months .


We will conduct telephone surveys with participants at six and 12 months to assess study outcomes .


We will collect a mailed saliva sample from patients reporting 7-day abstinence on the telephone surveys .


The primary outcome will be cotinine-validated abstinence at 12-month follow-up .


Mental health patients are a high-risk smoking population with significant barriers to cessation .


This study will evaluate the efficacy of a program that proactively reaches out to smokers with a mental health treatment history to engage them into telephone cessation counseling targeted to the needs of mental health patients .


Clinicaltrials.gov : NCT01737281 ( registered November 5 , 2012 ) .


An effective and well tolerated treatment is needed for patients with early HER2-positive breast cancer who do not achieve a pathological complete response after neoadjuvant therapy .


The AVATAXHER trial aimed to predict pathological complete response early with the use of PET and to investigate whether the addition of bevacizumab could improve the proportion of patients achieving a pathological complete response in patients unlikely to respond to treatment .


AVATAXHER was a randomised , open-label , non-comparative , multicentre phase 2 study that enrolled women ( 18 years of age ) with early-stage HER2-positive breast cancer from 26 oncology centres in France .


Patients initially received two cycles of neoadjuvant docetaxel ( 100 mg/m ( 2 ) intravenously every 3 weeks ) plus trastuzumab ( 8 mg/kg intravenously every 3 weeks then 6 mg/kg intravenously every 3 weeks for the second course ) .


Before the first and second cycles , [ ( 18 ) F ] - fluorodeoxyglucose ( FDG ) PET was done and the change in standardised uptake value was used to predict pathological complete response in each patient .


Patients who were predicted to be responders on PET continued to receive standard therapy .


Predicted non-responders were randomly assigned ( 2:1 ) to receive four cycles of docetaxel ( 100 mg/m ( 2 ) intravenously every 3 weeks ) and trastuzumab ( 6 mg/kg intravenously every 3 weeks ) plus bevacizumab ( 15 mg/kg intravenously every 3 weeks ; group A ) or continue on docetaxel plus trastuzumab alone ( group B ) .


Randomisation was open label and was done by an adaptive minimisation method .


Although investigators and patients were aware of group assignment , the anatomo-pathologist in charge of centralised review of surgical samples and lymph nodes was masked to treatment assignment .


The primary endpoint was centrally assessed pathological complete response according to the Chevallier classification .


Efficacy analyses were done in the intention-to-treat population .


Safety analyses in this Article were done on all patients who received at least one dose of treatment starting from cycle 3 .


Survival outcomes are not yet mature .


This study is registered with ClinicalTrials.gov ( NCT01142778 ) and EUDRACT ( 2009-013410-26 ) .


Between May 19 , 2010 , and Oct 1 , 2012 , 152 patients were recruited for the study .


Ten patients were subsequently excluded , leaving 142 patients in the intention-to-treat population .


Of these 142 patients , 69 were predicted by [ ( 18 ) F ] - FDG PET to be treatment responders after two cycles of treatment .


The 73 predicted non-responders were randomly assigned to group A ( n = 48 ) and group B ( n = 25 ) .


Pathological complete responses were noted in 37 ( 536 % , 95 % CI 412-657 ) of the PET responders , 21 ( 438 % , 295-588 ) of those in group A , and six ( 240 % , 94-451 ) of those in group B. Incidences of grade 3-4 adverse events were similar in all three groups .


The most common grade 3-4 adverse events were neutropenia ( four in PET responders , five in group A , and three in group B ) , febrile neutropenia ( one , three , and one , respectively ) , and myalgia ( four , none , and one , respectively ) .


Overall , 24 serious adverse events were reported in 15 patients ( PET responders : nine events in four [ 6 % ] of 67 patients ; group A : 14 events in ten [ 21 % ] of 47 patients ; group B : one event in one [ 4 % ] of 25 patients ) .


No deaths occurred during the study .


In patients with HER2-positive breast cancer , early PET assessment can help to identify non-responders to neoadjuvant docetaxel plus trastuzumab therapy .


In these patients , the addition of bevacizumab can increase the proportion of patients achieving a pathological complete response .


This potential new role for PET and the activity of bevacizumab in this setting need to be confirmed in larger phase 3 trials .


Roche France .


To describe secondary analyses from a 12-week , randomized , open-label trial where adult schizophrenia outpatients receiving risperidone , olanzapine , or aripiprazole were switched to iloperidone .


Patients were randomized into two groups : one where the antecedent antipsychotic dose was titrated downwards to zero over 2 weeks ( n = 240 ) , and the other group where the antecedent antipsychotic was abruptly stopped ( n = 260 ) .


Adaptations of the Clinical Global Impression scale were used to evaluate clinical changes .


Other assessments included the reporting of adverse events ( AEs ) , study discontinuation , body weight , and metabolic variables .


Improvement was steady throughout the study for both gradual - and immediate-switch groups starting at Week 1 and continuing through Week 12 .


Discontinuations due to AEs in the first 2 weeks of treatment were higher for the immediate-switch group compared with the gradual-switch group ( 10.8 % vs. 5.4 % , NNT 19 , 95 % CI 10-151 ) .


Fewer patients in the gradual-switch group experienced dizziness as an AE , whereas a higher percentage of patients in the immediate-switch group exhibited earlier onset of a therapeutic response within the first 2 weeks ; both groups were comparable thereafter with low rates of dizziness and similar efficacy outcomes .


Switching to iloperidone can be accomplished either with a gradual crossover or immediate discontinuation of the prior antipsychotic ; however , the immediate-switch method is associated with greater proportion of initial dizziness .


The observed outcomes are consistent with what has been previously reported regarding iloperidone 's favorable akathisia/EPS profile and modest impact on somnolence/sedation , body weight , and metabolic variables .


When performing clinical trials involving acupuncture , it can be difficult to choose a placebo control .


To validate the Park sham needle for use as a double-blind control intervention .


Two different methods were employed .


First , a researcher blinded to needle type administered the Park sham or a real needle , chosen at random , on the arms of 16 healthy volunteers .


The researcher and the volunteers independently recorded which needle type they thought had been applied at each acupuncture point .


Second , 19 patients with shoulder impingement syndrome were randomly assigned to receive acupuncture applied with the real needle or the Park sham needle , once a week for 6 weeks alongside a course of physiotherapy .


At the end of the 6 sessions the patients recorded which needle type they thought was being used .


The results were analyzed with a Fisher 's exact test .


This study was carried out in the Outpatient Department of Physiotherapy in Charing Cross Hospital , London , UK , on healthy volunteers and patients with shoulder impingement pain .


The age range was 23 to 54 and 22 to 74 years respectively .


Of the healthy volunteers , there was no difference ( P = 0.23 ) between the number of needles that were correctly ( n = 43 ) or incorrectly identified ( n = 53 ) .


All patients thought that they had received the real needles .


The researcher correctly identified all needles that were applied .


The researcher delivering the acupuncture recognized the needle type .


However , both healthy and patient volunteers were blind to the needle type .


This demonstrates that the Park sham needle is an effective single-blind control .


It should be noted that the number of patients recruited was small and the study was underpowered to detect an effect of treatment .


The proteasome inhibitor bortezomib was initially approved for the treatment of relapsed mantle-cell lymphoma .


We investigated whether substituting bortezomib for vincristine in frontline therapy with R-CHOP ( rituximab , cyclophosphamide , doxorubicin , vincristine , and prednisone ) could improve outcomes in patients with newly diagnosed mantle-cell lymphoma .


In this phase 3 trial , we randomly assigned 487 adults with newly diagnosed mantle-cell lymphoma who were ineligible or not considered for stem-cell transplantation to receive six to eight 21-day cycles of R-CHOP intravenously on day 1 ( with prednisone administered orally on days 1 to 5 ) or VR-CAP ( R-CHOP regimen , but replacing vincristine with bortezomib at a dose of 1.3 mg per square meter of body-surface area on days 1 , 4 , 8 , and 11 ) .


The primary end point was progression-free survival .


After a median follow-up of 40 months , median progression-free survival ( according to independent radiologic review ) was 14.4 months in the R-CHOP group versus 24.7 months in the VR-CAP group ( hazard ratio favoring the VR-CAP group , 0.63 ; P < 0.001 ) , a relative improvement of 59 % .


On the basis of investigator assessment , the median durations of progression-free survival were 16.1 months and 30.7 months , respectively ( hazard ratio , 0.51 ; P < 0.001 ) , a relative improvement of 96 % .


Secondary end points were consistently improved in the VR-CAP group , including the complete response rate ( 42 % vs. 53 % ) , the median duration of complete response ( 18.0 months vs. 42.1 months ) , the median treatment-free interval ( 20.5 months vs. 40.6 months ) , and the 4-year overall survival rate ( 54 % vs. 64 % ) .


Rates of neutropenia and thrombocytopenia were higher in the VR-CAP group .


VR-CAP was more effective than R-CHOP in patients with newly diagnosed mantle-cell lymphoma but at the cost of increased hematologic toxicity .


( Funded by Janssen Research and Development and Millennium Pharmaceuticals ; LYM-3002 ClinicalTrials.gov number , NCT00722137 . )


To investigate a new therapeutic strategy , with rapid corticosteroid dose tapering and limited cyclophosphamide ( CYC ) exposure , for older patients with systemic necrotizing vasculitides ( SNVs ; polyarteritis nodosa [ PAN ] , granulomatosis with polyangiitis [ Wegnener 's ] [ GPA ] , microscopic polyangiitis [ MPA ] , or eosinophilic GPA [ Churg-Strauss ] [ EGPA ] ) .


A multicenter , open-label , randomized controlled trial comprising patients 65 years old and newly diagnosed as having SNV was conducted .


The experimental treatment consisted of corticosteroids for 9 months and a maximum of six 500-mg fixed-dose intravenous ( IV ) CYC pulses , every 2-3 weeks , then maintenance azathioprine or methotrexate .


The control treatment included 26 months of corticosteroids for all patients , combined with 500 mg/m ( 2 ) IV CYC pulses , every 2-3 weeks until remission , then maintenance for all patients with GPA or MPA and for those with EGPA or PAN with a Five-Factors Score ( FFS ) of 1 .


Randomization used a 1:1 ratio computer-generated list and was performed centrally with sealed opaque envelopes .


The primary outcome measure was 1 serious adverse event ( SAE ) occurring within 3 years of followup .


Secondary outcome measures included remission and relapse rates .


Among the 108 patients randomized , 4 were excluded ( early consent withdrawal or protocol violation ) .


Mean SD age at diagnosis was 75.2 6.3 years .


Analysis at 3 years included 53 patients ( 21 GPA , 21 MPA , 8 EGPA , and 3 PAN ) in the experimental arm and 51 patients ( 15 GPA , 23 MPA , 6 EGPA , and 7 PAN ) in the conventional arm .


In total , 32 ( 60 % ) versus 40 ( 78 % ) had 1 SAE ( P = 0.04 ) , most frequently infections ; 6 ( 11 % ) versus 7 ( 14 % ) failed to achieve remission ( P = 0.71 ) ; 9 ( 17 % ) versus 12 ( 24 % ) died ( P = 0.41 ) ; and 20 ( 44 % ) of 45 versus 12 ( 29 % ) of 41 survivors in remission experienced a relapse ( P = 0.15 ) .


For older SNV patients , an induction regimen limiting corticosteroid exposure and with fixed low-dose IV CYC pulses reduces SAEs in comparison to conventional therapy , and does not affect the remission rate .


Three-year relapse rates remain high for both arms .


Acupuncture is increasingly used in patients with allergic asthma , but there is a lack of evidence on the cost-benefit relationship of this treatment .


The aim of this study was to assess economic aspects of additional acupuncture treatment in patients with allergic bronchial asthma compared to patients receiving routine care alone .


DESIGN , SUBJECTS , INTERVENTION , OUTCOME MEASURES : In a randomized controlled trial , patients with allergic bronchial asthma were either allocated to a group receiving acupuncture immediately or a waiting-list control group .


Both groups were free to use routine care treatment .


The resource consumption , costs , and health-related quality of life were evaluated at baseline , and after 3 and 6 months by using statutory health insurance information and standardized questionnaires .


Main economic outcome parameters were direct and indirect cost differences during the study period and the incremental cost-effectiveness ratio ( ICER ) of acupuncture treatment .


Three hundred and six ( 306 ) patients ( 159 acupuncture ; 147 controls ) were included ( mean age 46.513.11 years , female 57.2 % ) and were comparable at baseline .


Acupuncture treatment was associated with significantly higher costs compared to control patients ( overall costs : 860.76 [ 95 % confidence interval ( CI ) 705.04-1016 .47 ] versus 518.80 [ 95 % CI 356.66-680 .93 ] ; p = 0.003 ; asthma-related costs : 517.52 [ 95 % CI 485.63-549 .40 ] versus 144.87 [ 95 % CI 111.70-178 .05 ] ; p < 0.001 ) .


These additional costs seem essentially driven by acupuncture costs themselves ( 378.40 [ 95 % CI 367.10-389 .69 ] ) .


However , acupuncture was associated with superior effectiveness in terms of quality-adjusted life years ( QALYs ) .


Resulting ICER lay between 23,231 ( overall ) and 25,315 ( diagnosis-specific ) per additional QALY .


When using German acupuncture prices of year 2012 , the ICER would improve to 12.810 ( overall ) versus 14,911 ( diagnosis-specific ) per QALY gained .


Treating patients who have allergic bronchial asthma with acupuncture in addition to routine care resulted in additional costs and better effects in terms of patients ' quality of life .


Acupuncture therefore seems to be a useful and cost-effective add-on treatment .


The aim of this study was to assess whether deferred stenting might reduce no-reflow and salvage myocardium in primary percutaneous coronary intervention ( PCI ) for ST-segment elevation myocardial infarction ( STEMI ) .


No-reflow is associated with adverse outcomes in STEMI .


This was a prospective , single-center , randomized , controlled , proof-of-concept trial in reperfused STEMI patients with 1 risk factors for no-reflow .


Randomization was to deferred stenting with an intention-to-stent 4 to 16 h later or conventional treatment with immediate stenting .


The primary outcome was the incidence of no - / slow-reflow ( Thrombolysis In Myocardial Infarction 2 ) .


Cardiac magnetic resonance imaging was performed 2 days and 6 months after myocardial infarction .


Myocardial salvage was the final infarct size indexed to the initial area at risk .


Of 411 STEMI patients ( March 11 , 2012 to November 21 , 2012 ) , 101 patients ( mean age , 60 years ; 69 % male ) were randomized ( 52 to the deferred stenting group , 49 to the immediate stenting ) .


The median ( interquartile range [ IQR ] ) time to the second procedure in the deferred stenting group was 9 h ( IQR : 6 to 12 h ) .


Fewer patients in the deferred stenting group had no - / slow-reflow ( 14 [ 29 % ] vs. 3 [ 6 % ] ; p = 0.006 ) , no reflow ( 7 [ 14 % ] vs. 1 [ 2 % ] ; p = 0.052 ) and intraprocedural thrombotic events ( 16 [ 33 % ] vs. 5 [ 10 % ] ; p = 0.010 ) .


Thrombolysis In Myocardial Infarction coronary flow grades at the end of PCI were higher in the deferred stenting group ( p = 0.018 ) .


Recurrent STEMI occurred in 2 patients in the deferred stenting group before the second procedure .


Myocardial salvage index at 6 months was greater in the deferred stenting group ( 68 [ IQR : 54 % to 82 % ] vs. 56 [ IQR : 31 % to 72 % ] ; p = 0.031 ] .


In high-risk STEMI patients , deferred stenting in primary PCI reduced no-reflow and increased myocardial salvage .


( Deferred Stent Trial in STEMI ; NCT01717573 ) .


Cognitive deficits that characterize schizophrenia are present in the prodrome , worsen with illness onset , and predict functional outcome .


Cognitive dysfunction is thus a critical target for early intervention in young individuals with recent onset schizophrenia .


This 2-site double-blind randomized controlled trial investigated cognitive training of auditory processing/verbal learning in 86 subjects with recent onset schizophrenia ( mean age of 21 years ) .


Subjects were given laptop computers to take home and were asked to perform 40 hours of training or 40 hours of commercial computer games over 8 weeks .


We examined cognitive measures recommended by the Measurement and Treatment Research to Improve Cognition in Schizophrenia initiative ( MATRICS ) , symptoms , and functioning .


We also assessed baseline reward anticipation to index motivational system functioning and measured changes in auditory processing speed after 20 hours of training to assess target engagement .


Auditory training subjects demonstrated significant improvements in global cognition , verbal memory , and problem solving compared with those of computer games control subjects .


Both groups showed a slight but significant decrease in symptoms and no change in functional outcome measures .


Training-induced cognitive gains at posttraining showed significant associations with reward anticipation at baseline and with improvement in auditory processing speed at 20 hours .


Neuroscience-informed cognitive training via laptop computer represents a promising treatment approach for cognitive dysfunction in early schizophrenia .


An individual 's baseline motivational system functioning ( reward anticipation ) , and ability to engage in auditory processing speed improvement , may represent important predictors of treatment outcome .


Future studies must investigate whether cognitive training improves functioning and how best to integrate it into critical psychosocial interventions .


To explore the possible mechanisms for improving lower extremity motor function in patients with early stroke through combining magnetic resonance diffusion tensor imaging ( DTI ) technology and functional electrical stimulation ( FES ) based on human walking patterns .


From August 2012 to September 2013 , a total of 48 eligible patients were stratified according to age , gender , disease course , Brunnstrom staging and types of stroke .


And the Minimize software was used to divided them randomly into four-channel FES group ( n = 18 ) , dual-channel FES group ( n = 15 ) and comfort stimulation group ( n = 15 ) .


For all three groups , general medication and standard rehabilitation were provided .


Based on normal walking pattern design of FES treatment , four-channel FES groups received the stimulations of quadriceps , hamstring , anterior tibialis and medial gastrocnemius .


For the dual-channel FES group , the stimulations of tibialis anterior , peroneus longus and peroneus brevis muscles were applied .


In comfort electrical stimulation group , the electrode positions were identical to the stimulation group , but there was no current output during stimulation .


Before and after 3-week treatment , three groups received weekly rehabilitation evaluations of Fugl-Meyer assessment ( FMA ) , posture assessment of stroke scale ( PASS ) , Brunel balance assessment ( BBA ) , Berg balance scale ( BBS ) and modified Barthel index ( MBI ) .


Before and after treatment , DTI examination was performed for some patients .


Among three groups , general patient profiles and pre-treatment evaluations showed no significant difference .


For intra-group comparisons versus pre-treatment , at week 1 , 2 and 3 , the scores of PASS , BBA , BBS , FMA and MBI had statistically significant differences ( P < 0.05 ) ; At week 3 post-treatment , when four-channel and double-channel FES groups were compared versus pre-treatment , the scores of ipsilateral FA had statistically significant differences ( P < 0.05 ) .


At week 1 post-treatment , MBI had statistically significant difference among 3 groups ( P = 0.037 ) .


As compared with placebo , four-channel group had statistically significant difference [ ( 52 12 ) vs ( 38 18 ) , P < 0.05 ] ; At week 2 post-treatment , the scores of PASS and MBI were ( 29 3 , 73 13 ) in four-channel FES group versus ( 24 8 , 60 17 ) in dual-channel FES group .


And the scores of PASS , BBA , BBS , FMA and MBI were ( 9 3 , 8.3 2.4 , 37 7 , 22 5 , 73 13 ) in four-channel FES group versus ( 21 7 , 6.2 3.1 , 24 16 , 15 8 , 47 20 ) in comfort electrical stimulation group .


When dual-channel FES and comfort stimulation groups were compared , MBI had significant statistical difference [ ( 60 17 ) vs ( 47 20 ) , P < 0.05 ] .


At week 3 post-treatment , four-channel and dual-channel FES groups were compared , there was also statistical significance in FMA [ ( 25 5 ) vs ( 20 7 ) , P = 0.055 ] .


The scores of PASS , BBS , FMA and MBI were ( 31 3 , 43 8 , 25 5 , 81 13 ) in four-channel FES group versus ( 25 8 , 29 17 , 17 9 , 54 25 ) in comfort stimulation group respectively .


When dual-channel FES and comfort stimulation groups were compared , the scores of MBI were ( 71 15 ) and ( 54 25 ) respectively .


And the difference was statistically significant ( P < 0.05 ) .


At week 3 post-treatment , the scores of FA significantly increased [ four-channel FES group ( 0.321 0.172 ) vs comfort stimulation group ( 0.217 0.135 ) ( P = 0.020 ) ] .


When dual-channel FES group ( 0.333 0.164 ) and comfort stimulation group ( 0.217 0.135 ) ( P = 0.049 ) were compared , the differences were statistically significant .


DTI showed that four-channel FES group increased significantly , but contralateral fiber bundle was not obvious .


And the improvements of dual-channel FES and comfort stimulation groups were insignificant .


Compared with traditional dual-channel FES , functional electrical stimulation based on human walking patterns is more efficacious .


And it helps to restore brain structure and function and promote motor function recovery in patients with early stroke .


This study sought to determine the effects of lavender aromatherapy on pain following needle insertion into a fistula in patients undergoing hemodialysis .


This is a randomized controlled clinical trial in which 92 patients undergoing hemodialysis with arteriovenous fistulas were randomly divided into two groups .


The experimental-group patients inhaled lavender essence with a concentration of 10 % for 5min during 3 hemodialysis sessions , while the control-group patients received aromatherapy free of lavender essence .


The mean VAS pain intensity score in the experimental and control groups before the intervention was 3.780.24 and 4.160.32 , respectively ( p = 0.35 ) .


The mean VAS pain intensity score in the experimental and control groups after three aromatherapy sessions was 2.360.25 and 3.430.31 , respectively ( p = 0.009 ) .


Lavender aromatherapy may be an effective technique to reduce pain following needle insertion into a fistula in hemodialysis patients .


Hyperparathyroidism ( HPT ) in multiple endocrine neoplasia ( MEN ) type 1 is associated with multiglandular parathyroid disease .


Previous retrospective studies comparing subtotal parathyroidectomy ( SP ) and total parathyroidectomy with autotransplantation ( TP/AT ) have not established clearly better outcomes with either procedure .


Patients were assigned randomly to either SP or TP/AT and data were collected prospectively .


The rates of persistent HPT , recurrent HPT , and postoperative hypoparathyroidism were compared .


The study cohort included 32 patients randomized to receive either SP or TP/AT ( mean follow-up , 7.5 5.7 years ) .


The overall rate of recurrent HPT was 19 % ( 6/32 ) .


Recurrent HPT occurred in 4 of 17 patients ( 24 % ) treated with SP and 2 of 15 patients ( 13 % ) treated with TP/AT ( P = .66 ) .


Permanent hypoparathyroidism occurred in 3 of 32 patients ( 9 % ) overall .


The rate of permanent hypoparathyroidism was 12 % in the SP group ( 2/17 ) and 7 % in the TP/AT group ( 1/15 ) .


A second operation was performed in 4 of 17 patients initially treated with SP ( 24 % ) , compared with 1 of 15 patients undergoing TP/AT ( 7 % ; P = .34 ) .


This randomized trial of SP and TP/AT in patients with MEN 1 failed to show any difference in outcomes when comparing results of SP versus TP/AT .


Both procedures are associated with acceptable results , but SP may have advantages in that is involves only 1 surgical incision and avoids an obligate period of transient postoperative hypoparathyroidism .


Adhesions develop in over 90 % of patients after intra-abdominal surgery .


Adhesion barriers are rarely used despite the high morbidity caused by intra-abdominal adhesions .


Only one of the currently available adhesion barriers has demonstrated consistent evidence for reducing adhesions in visceral surgery .


This agent has limitations through poor handling characteristics because it is sticky on both sides .


C-Qur Film is a novel thin film adhesion barrier and it is sticky on only one side , resulting in better handling characteristics .


The objective of this study is to assess efficacy and safety of C-Qur Film to decrease the incidence of adhesions after colorectal surgery .


This is a prospective , investigator initiated , randomized , double-blinded , multicenter trial .


Eligible patients undergoing colorectal resection requiring temporary loop ileostomy or loop/split colostomy by laparotomy or hand assisted laparoscopy will be included in the trial .


Before closure , patients are randomized 1:1 to either the treatment arm ( C-Qur Film ) or control arm ( no adhesion barrier ) .


Patients will return 8 to 16 weeks post-colorectal resection for take down of their ostomy .


During ostomy takedown , adhesions will be evaluated for incidence , extent , and severity .


The primary outcome evaluation will be assessment of adhesions to the incision site .


It is hypothesized that the use of C-Qur Film underneath the primary incision reduces the incidence of adhesion at the incision by 30 % .


To demonstrate 30 % reduction in the incidence of adhesions , a sample size of 84 patients ( 32 + 10 per group ( 25 % drop out ) ) is required ( two-sided test , = 0.05 , 80 % power ) .


Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic ` hand-assisted ' colorectal surgery .


We chose incidence of adhesions to the incision site as primary outcome measure since clinical outcomes such as small bowel obstruction , secondary infertility and adhesiolysis related complications are considered multifactorial and difficult to interpret .


Incidence of adhesions at repeat surgery is believed to be the most valuable surrogate endpoint for clinically relevant adhesion prevention , since small bowel obstruction and adhesiolysis at repeat surgery are not likely to occur when complete adhesion reduction in a patient is accomplished .


ClinicalTrials.gov Identifier NCT01872650 , registration date 6 June 2013 .


To assess the impact of empowerment ( health coaching , HC ) on toothbrushing self-efficacy ( TBSE ) and toothbrushing frequency ( TB ) and their effects on diabetes management ( HbA1c , physical activity ) and quality of life in comparison to health education ( HE ) among patients with diabetes type 2 ( DM2 ) .


The data ( HbA1c [ glycated haemoglobin ] , TB , physical activity , TBSE , quality of life ) were collected at baseline and at post-intervention at outpatient clinics of two hospitals in Istanbul , Turkey .


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


At baseline , there were no statistical differences between HC and HE groups in terms of all measures ( P > 0.05 ) .


At post-intervention , there was improvement in oral health - and diabetes-related variables in the HC group , whereas only TBSE and TB slightly improved in the HE group ( P < 0.05 ) .