Forty-one patients with active RA despite disease-modifying antirheumatic drug therapy were randomised @:@ to CZP ( CZP loading dose @mg every @weeksat weeks @-@ ; CZP @mg every @weeksat weeks @-@ ) or placeboCZP ( placebo at weeks @-@ ; CZP loading dose at weeks @-@ ; CZP @mg every @weeks at weeks @-@ ) .


Contrast-enhanced MRI of one hand and wrist was acquired at baseline ( week @ ) and weeks @ , @ , @ , @ and @ .


All six time points were read simultaneously , blinded to time , using the Outcome Measures in Rheumatology Clinical Trials RA MRI scoring system .


Primary outcome was change in synovitis score in the CZP group ; secondary outcomes were change in bone oedema ( osteitis ) and erosion scores and clinical outcome measures .


Forty patients were treated ( @ CZP , @ placeboCZP ) , and @ ( @ CZP , @ placeboCZP ) completed week @ .


In the CZP group , there were significant reductions from baseline synovitis ( Hodges-Lehmann estimate of median change , -@ , p = @ ) and osteitis scores ( -@ , p = @ ) at week @ .


Numerical , but statistically insignificant , MRI inflammation reductions were observed at weeks @-@ in the CZP group .


No significant change was seen in bone erosion score .


Improvements across all clinical outcomes were seen in the CZP group .


CZP reduced MRI synovitis and osteitis scores at week @ , despite small sample size and the technical challenge of reading six time points simultaneously .


This study provides essential information on optimal MRI timing for subsequent trials .


High-density lipoproteins ( HDLs ) have several potentially protective vascular effects .


Most clinical studies of therapies targeting HDL have failed to show benefits vs. placebo .


To investigate the effects of an HDL-mimetic agent on atherosclerosis by intravascular ultrasonography ( IVUS ) and quantitative coronary angiography ( QCA ) .


A prospective , double-blinded , randomized trial was conducted at @ centres in the USA , the Netherlands , Canada , and France .


Intravascular ultrasonography and QCA were performed to assess coronary atherosclerosis at baseline and @ ( @-@ ) weeks after the last study infusion .


Five hundred and seven patients were randomized ; @ and @ had paired IVUS and QCA measurements , respectively .


Patients were randomized to receive @ weekly infusions of placebo , @ mg/kg , @ mg/kg , or @ mg/kg CER-@ .


The primary efficacy parameter was the nominal change in the total atheroma volume .


Nominal changes in per cent atheroma volume on IVUS and coronary scores on QCA were also pre-specified endpoints .


The nominal change in the total atheroma volume ( adjusted means ) was -@ , -@ , -@ , and -@ mm ( @ ) with placebo , CER-@ @ mg/kg , @ mg/kg , and @ mg/kg , respectively ( primary analysis of @ mg/kg vs. placebo : P = @ ) .


There was also no difference among groups for the nominal change in per cent atheroma volume ( @ , -@ , @ , and @ % ; nominal P = @ for @ mg/kg vs. placebo ) .


Change in the coronary artery score was -@ , -@ , -@ , and -@ mm ( nominal P = @ , @ , @ ) , and change in the cumulative coronary stenosis score was -@ , @ , @ , and -@ % ( compared with placebo , nominal P = @ for @ mg/kg and nominal P = @ for @ mg/kg ) .


The number of patients with major cardiovascular events was @ ( @ % ) , @ ( @ % ) , @ ( @ % ) , and @ ( @ % ) in the four groups .


CER-@ infusions did not reduce coronary atherosclerosis on IVUS and QCA when compared with placebo .


Whether CER-@ administered in other regimens or to other populations could favourably affect atherosclerosis must await further study .


Name of the trial registry : Clinicaltrials.gov ; Registry 's URL : http://clinicaltrials.gov/ct@/show/NCT@?term=cer-@&rank=@;


To observe the effects of electroacupuncture at Neiguan ( PC @ ) and Jianshi ( PC @ ) com - bined with granisetron on nausea and vomiting as well as serum levels of @-hydroxy tryptamine ( @-HT ) and dopamine ( DA ) in chemotherapy patients .


Seventy-two chemotherapy patients who met the inclusive criteria were randomly divided into an observation group ( @ cases ) and a control group ( @ cases ) .


The patients in the observation group were treated with electroacupuncture at Neiguan ( PC @ ) and Jianshi ( PC @ ) combined with granisetron injection ; the patients in the control group were treated with electroacupuncture at sham-point @ and sham - point @ , and the rest treatment was identical to the observation group .


After @-day treatment , the clinical indices including times of vomiting and severity of nausea , etc. were observed in the two groups .


( @ ) At the acute stage within @ h , the times of vomiting in the two groups were not significantly different ( P > @ ) ; at the delay stage , the severity of nausea was significantly higher in the control group ( P < @ ) .


( @ ) As for the comprehensive efficacy and rate of complete control , there was no obvious difference between the two groups at the acute stage ( P > @ ) ; while in the delay stage , the rate of complete control in the observation group was superior to that in the control group ( P < @ ) .


( @ ) Compared before and after the treatment , serum levels of @-HT and DA were evidently reduced in the observation group ( both P < @ ) , while those in the control group were not significantly changed after treatment ( both P > @ ) .


Electroacupuncture at Neiguan ( PC @ ) and Jianshi ( PC @ ) combined with granisetron could obviously relieve the nausea in chemotherapy patients at the delay stage .


The effect mechanism is possibly related to reducing the content of @-HIT nndl nA


The purpose of this study was to compare the reduction of the clinical signs of inflammation by two power interdental cleaning devices combined with a manual toothbrush .


Sixty-nine subjects completed this randomized , four-week , single-blind , two-group , parallel clinical study .


Subjects were randomly assigned to one of two treatment groups : Waterpik Water Flosser ( WF ) plus a manual toothbrush ; or Sonicare Air Floss Pro ( AFP ) plus a manual toothbrush .


All subjects received both written and verbal instructions and demonstrated proficiency prior to starting the study .


Instructions were reviewed at the two-week visit ( W@ ) .


Data were evaluated for whole mouth , lingual , and facial areas for bleeding on probing ( BOP ) and Modified Gingival Index ( MGI ) .


Plaque data were recorded for whole mouth , lingual , facial , approximal , and marginal areas of the tooth using the Rustogi Modification of the Navy Plaque Index ( RMNPI ) .


BOP , MGI , and RMNPI were scored at baseline ( BSL ) , two weeks , and four weeks ( W@ ) .


Both groups showed significant reductions in BOP and MGI from baseline for all regions and time points measured ( p < @ ) .


Both groups showed significant reductions from baseline for all areas at W@ for RMNPI ( p < @ ) .


The WF group was significantly more effective than the AFP group at reducing bleeding and gingivitis for all areas measured at all time points .


At W@ , the WF group was @ % more effective for bleeding and @ % for gingivitis ( p < @ ) .


Plaque accumulation was significantly less at W@ for the WF group compared to the AFP group ( @ % , p @ ) .


The Waterpik Water Flosser is significantly more effective than the Sonicare Air Floss Pro for reducing clinical signs of inflammation .


Streptococcus pneumoniae infections have periodically caused significant morbidity and outbreaks among military personnel , especially trainees .


This study evaluated the effectiveness of the @-valent polysaccharide pneumococcal vaccine ( PPV@ ) in reducing pneumonia in healthy military trainees .


From @-@ , @ military trainees from @ US training camps were enrolled in a double-blind , placebo-controlled trial of PPV@ .


Participants were closely monitored during basic training for radiographically confirmed pneumonia etiology and loss-of-training days .


Participants were also followed using electronic medical encounter data until @ June @ for three additional outcomes : any-cause pneumonia , any acute respiratory disease , and meningitis .


Comparison of demographic data by study arm suggested the randomization procedures were sound .


During basic training , @ study participants developed radiographically confirmed pneumonia .


None had evidence of S. pneumoniae infection , but other etiologies included adenovirus ( @ % ) , Chlamydophila pneumoniae ( @ % ) , and Mycoplasma pneumoniae ( @ % ) .


During the follow-up period , many study participants , in both the vaccine and placebo groups , had clinical encounters for the medical outcomes of interest .


However , Cox 's proportional hazard modeling revealed no evidence of a protective vaccine effect during recruit training ( radiographically confirmed pneumonia ) or up to @ years after enrollment ( any-cause pneumonia , any acute respiratory disease , or meningitis ) .


Data from this large , double-blind , placebo controlled trial do not support routine use of PPV@ among healthy new military trainees .


This clinical trial was registered at clinicaltrials.gov ( registration number NCT@ , http://www.clinicaltrials.gov/ct@/show/NCT@?term=NCT@&rank=@ ) .


Both unsedated transoral endoscopy ( TOE ) and sedated TOE have some drawbacks in clinical practice .


Unsedated transnasal endoscopy ( TNE ) has been suggested as an alternative to both methods .


This study aimed to determine the advantages of TNE in patients who have previously undergone unsedated conventional TOE .


Patients who had received an unsedated TOE in the last @ months and were scheduled for a second upper endoscopy were included .


They were randomized to undergo either unsedated TOE , using a standard endoscope , or unsedated TNE , using an ultrathin endoscope .


Post-procedure , patients were asked to complete a questionnaire to assess pain , discomfort and acceptability of the procedure , and to compare the current procedure with their previous unsedated TOE .


Endoscope insertion rate , procedure duration , and side-effects were recorded .


Each group included @ patients .


With the exception of nasal pain , the tolerability and acceptance were significantly greater in the unsedated TNE group .


Significantly more TNE patients ( @ % ) found the current endoscopic procedure to be better than their previous TOE when compared with patients who had received a second TOE ( @ % ) .


A repeat procedure was significantly more acceptable for TNE patients when compared to the TOE group ( @ % vs. @ % ) .


The duration of endoscopy was significantly shorter in TOE than in TNE ( p < @ ) .


Endoscope insertion failed in @ % and mild epistaxis was observed in @ % of TNE patients .


Unsedated TNE was better tolerated in endoscopy experienced patients when compared with unsedated TOE .


The majority of patients found TNE more acceptable and preferable to TOE , suggesting that TNE should become a more common practice in clinics when applicable .


Little is known about mode of death after acute heart failure ( AHF ) hospitalization .


In the RELAX-AHF ( Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure ) study , serelaxin , the recombinant form of human relaxin-@ , reduced post-discharge mortality at @ days in selected patients with AHF .


The goal of this study was to assess the effect of serelaxin on specific modes of death in patients with AHF .


The RELAX-AHF study randomized @,@ patients with AHF to @ h of therapy with intravenous serelaxin or placebo .


Patients were followed for vital status through @ days .


A blinded clinical events committee reviewed all deaths and adjudicated a cause of death on the basis of pre-specified criteria .


Cox proportional hazard models were used to assess the effect of serelaxin on each mode of death , on the basis of pre-specified groupings of mode of death .


There were @ deaths ( @ % ) : @ ( @ % ) due to HF , @ ( @ % ) due to sudden death , @ ( @ % ) due to other cardiovascular ( CV ) causes , @ ( @ % ) due to non-CV causes , and @ ( @ % ) classified as unknown .


The treatment effect of serelaxin was most pronounced on other CV deaths ( hazard ratio -LSB- HR -RSB- : @ ; @ % CI : @ to @ ; p = @ ) and sudden death ( HR : @ ; @ % CI : @ to @ ; p = @ ) .


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 -LSB- RELAX-AHF -RSB- ; NCT@ ) .


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 @-@ years in elementary schools .


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


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


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


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


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


The seroresponses for rubella were @ % for MMR SII ( ae ) , @ % for MMR II ( ae ) , @ % for MMR SII ( inj ) , and @ % for MMR II ( inj ) ( p = @ ) .


The seroresponse to mumps were @ % for MMR SII ( ae ) , @ % for MMR II ( ae ) , @ % for MMR SII ( inj ) , and @ % for MMR II ( inj ) ( p = @ ) .


The difference in the seroresponse of a @-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 .


We evaluated the efficacy and safety of S-@ plus oxaliplatin ( SOX ) as an alternative to cisplatin plus S-@ ( 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 ( @-@ mg/day S-@ for @ weeks with @ mg/m ( @ ) oxaliplatin on day @ , every @ weeks ) or CS ( S-@ for @ weeks with @ mg/m ( @ ) cisplatin on day @ , every @ 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 , @ patients were randomized from January @ to October @ .


In per-protocol population , SOX ( n = @ ) was noninferior to CS ( n = @ ) in PFS -LSB- median , @ versus @ months ; HR @ , @ % confidence interval ( CI ) @-@ @ ; predefined noninferiority margin @ -RSB- .


The median OS for SOX and CS were @ and @ months , respectively ( HR @ with @ % CI @-@ @ ) .


In the intention-to-treat population ( SOX , n = @ ; CS , n = @ ) , the HRs in PFS and OS were @ ( @ % CI @-@ @ ) and @ ( @ % CI @-@ @ ) , respectively .


The most common grade @ adverse events ( SOX versus CS ) were neutropenia ( @ % versus @ % ) , anemia ( @ % versus @ % ) , hyponatremia ( @ % versus @ % ) , febrile neutropenia ( @ % versus @ % ) , and sensory neuropathy ( @ % versus @ % ) .


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


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 @-year outcome data of @,@ 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 ( creatinine@ mol/l ) ; ejection fraction < @ % ; acute myocardial infarction ( MI ) within previous @ hrs ; > @ lesion/vessel ; > @ vessels treated ; lesion length > @ 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 @,@ complex patients , @ ( @ % ) were treated with Resolute ZES and @ ( @ % ) with Xience V EES .


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


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


TVF occurred in @ % of patients treated with Resolute ZES and @ % 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 @-year follow-up .


@ 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 @ 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 @ , @ , and @ 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 @ groups : AMT = @ mm , LST = @ mm , and LCT = @ mm ( P = @ ) ; however , @ months after surgery , the median thickness in the AMT group ( @ ) was significantly less than that of the LCT group ( @ ) ( P = @ ) or the LST group ( @ ) ( P = @ ) .


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 @ 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-@ soccer players .


A total of @ U-@ soccer players ( mean SD : age : @ @ years ; body mass : @ @ kg ; height : @ @ 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 @ , and its standard error of measurement ( SEM ) for absolute reliability was < @ % ( @ % ) .


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


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


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


The MICODT provided good sensitivity since elite U-@ soccer players were better than non-elite one on MICODT ( p = @ ; dz = @ -LSB- large -RSB- ) .


This was supported by an area under the ROC curve of @ ( CI @ % , @ to @ , p < @ ) .


The difference observed in these two groups in ICODT was not statistically significant ( p = @ ; dz = @ -LSB- small -RSB- ) , showing poor discriminant ability .


MICODT can be considered as more suitable protocol for assessing agility performance level than ICODT in U-@ 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 @-@ days , depending on the baseline international normalized ratio ( INR ) , before surgery aiming at an INR of @ was compared with interrupted warfarin for @ days with preoperative bridging with low-molecular-weight heparin ( LMWH ) at therapeutic dose for @ days .


Main safety outcome was pocket hematoma .


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


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


Pocket hematoma occurred in @ of @ patients ( @ % ) randomized to the bridged regimen and in @ of @ patients ( @ % ) randomized to reduced-dose warfarin .


One pocket hematoma in each group was severe .


There were no major hemorrhages or thromboembolism within the @-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 ( @ % ) than in the bridged regimen group ( @ % ) .


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 @ .


This study introduces a method to calculate myocardium blood flow ( MBF ) and coronary flow reserve ( CFR ) using the relatively low-dose dynamic @-row multi-detector computed tomography ( MDCT ) , validates the method against ( @ ) 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 @ normal subjects ( pilot group ) , the calculation method for MBF and CFR was established .


In the other @ 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 = @ ) .


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


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


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


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 @-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 : @ ) MBCT added to psychopharmacological treatment ; @ ) a brief structured group psychoeducational intervention added to psychopharmacological treatment ; @ ) standard clinical management , including psychopharmacological treatment .


Assessments will be conducted at screening , baseline , post-intervention ( @ weeks ) and @ 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 .


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 @,@ maternal deaths and @,@ to @,@ 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 .


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 @ subjects ( @-@ y , BMI @-@ kg/m ( @ ) ) with impaired glucose metabolism and features of the metabolic syndrome were randomized into three groups with @-week periods according to a parallel study design .


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


Altogether @ 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-@ PUFAs , while n-@ and n-@ 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 .


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 @ .


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


Enrolled animals were randomized to receive oral oclacitinib ( @-@ @ mg/kg twice daily for @ days , then once daily ) or oral ciclosporin ( @-@ @ mg/kg once daily ) for @ 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 ) -@ .


On days @ , @ , @ , @ , @ , @ and @ , the percentage reduction from baseline for owner-assessed pruritus changed from @ to @ % in the oclacitinib group compared with @ to @ % in the ciclosporin group ; differences were significant at all time points up to day @ .


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


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


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 -LSB- LALPF -RSB- ) , and the other @ 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 -LSB- VAS -RSB- ) were measured at baseline , @ days , and @ months after the surgery .


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


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 @ years ) were prospectively randomized @:@ to receive @ 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 @ h , programmed to deliver @ mg boluses of intravenous morphine with a @ min lockout .


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


Other measured parameters included opioid-related side effects and eligibility for discharge ( NCT@ ; September @ , @ ) .


Early pain intensity did not vary significantly between the active and placebo groups -LSB- mean ( standard deviation ) : @ ( @ ) vs. @ ( @ ) , p = @ -RSB- .


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


Overall opioid requirement over @ h , measured as oral morphine equivalent , was greater in the oxycodone group ( median -LSB- interquartile range -RSB- : @ -LSB- @-@ -RSB- mg vs. @ -LSB- @-@ @ -RSB- mg , p < @ ) .


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


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 @ patients suffering from PTSD were assessed ( mean age = @ years , SD = @ ; @ % females ) .


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


The trial lasted for @ 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 @ 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 @ % at @ days , @ % at @ year , and @ % at @ years .


Definite stent thrombosis was responsible for @ % of reinfarctions occurring within @ days and @ % of all reinfarctions within @ years .


Independent predictors of reinfarction were current smoking , Killip class @ , 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 -LSB- @ % confidence interval -RSB- = @ -LSB- @-@ @ -RSB- ; P < @ ) and all-cause mortality ( hazard ratio -LSB- @ % confidence interval -RSB- = @ -LSB- @-@ @ -RSB- ; P < @ ) .


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 .


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 ( @:@ ) 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 , @ in group A and @ in group B.


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


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


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


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 A@c over @ months , and costs from an RCT of @ uninsured Mexican Americans with type @ diabetes conducted in @ were utilized for secondary analyses in @ .


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


An incremental cost-effectiveness ratio of $ @ 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 @-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 .


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 @ stroke survivors and @ 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 ( @ ) startReact would be intact during hand extension in stroke survivors and that ( @ ) 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 = @ ) or with lyophilized bone allograft alone ( control group , n = @ ) .


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


The study was comprised of a total of @ 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 @ 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 @ to @ .


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


The @ 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 @ % milk , water ( in aisle and at checkout ) , and @ of @ 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 @ % 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 @ diabetes .


Adolescents recruited as part of a multicenter screening study ( n = @ , @ % female , aged @-@ years , mean duration @ years ; mean HbA@c @ % , @ mmol/mol ) underwent a @-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 ( @ vs. @ bpm ; P < @ ) and less heart rate variability ( SDNN @ vs. @ ms , P = @ ; RMSSD @ vs. @ ms , P = @ ) .


HbA@c was @ % ( @ mmol/mmol ) in the upper tertile vs. @ % ( @ mmol/mol ) in the lower tertiles ( P = @ ) .


In multivariable analysis , upper-tertile ACR was associated with faster heart rate ( = @ , @ % CI @-@ @ , P = @ ) and lower RMSSD ( = -@ , @ % CI -@ to -@ , P = @ ) , independent of age and HbA@c .


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 , @ hemodialysis ( HD ) patients ( mean ( SD ) age @ ( @ ) years ) were recruited .


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


The primary outcome was eKt/Vurea .


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


Outcomes were calculated from blood sampling collected pre - , post - and @ 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 ( @ % CI ) : @ ( -@ to @ ) ; TIME vs. CONT : @ ( @-@ @ ) ) .


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 : @ % ( @-@ @ ) ; TIME vs. CONT : @ % ( -@ to @ ) ) .


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 -LSB- eGFR -RSB- decreased to < @mL/min/@ @ m ( @ ) ) .


Patients with CKD who had at least one face-to-face outpatient encounter with a Cleveland Clinic health care provider as of January @ , @ , and at least @ eGFRs in the range of @-@mL / min/@ @ m ( @ ) measured at least @ 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 initiation@mL/min/@ @ m ( @ ) ) or later ( eGFR < @mL/min/@ @ m ( @ ) ) and was time-varying .


Death from any cause occurring from the time that eGFR was equal to @mL/min/@ @ m ( @ ) through September @ , @ .


The study population consisted of @ patients meeting inclusion criteria .


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


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


Overall , @ initiated dialysis early and @ had eGFRs decrease to < @mL/min/@ @ m ( @ ) .


Many participants ( n = @ ) 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 , @ ; @ % CI , @-@ @ ) .


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 @ to October @ .


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 < @ ) .


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 @ study sites .


A total of @ patients with active neovascular AMD .


Participants received intravitreal ranibizumab or aflibercept .


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


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 @ m or a height of @ 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 @ had a negative impact on BCVA .


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


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 @ diabetes mellitus ( T@DM ) patients ( one to three years post-diagnosis ) and their partners .


The course aims to support T@DM 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 @ recently diagnosed T@DM patients and their partners from general practices in six different regions in the Netherlands .


Patients need to be diagnosed with T@DM 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 ( T@ ) , directly after the programme ( T@ ) and six months post-programme ( T@ ) , 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 T@DM patients .


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


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


A total of @ patients were enrolled .


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


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


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


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


The primary efficacy end point was sustained virologic response @ weeks after therapy ( SVR@ ) .


SVR@ was achieved by @ of @ ( @ % ) TN patients receiving SOF , LDV , and RBV and @ of @ ( @ % ) of those receiving SOF , GS-@ , and RBV .


Of TN patients receiving @ weeks of SOF , LDV , and RBV , @ of @ ( @ % ) achieved SVR@ .


All noncirrhotic prior null responders receiving @ weeks of SOF along with another direct-acting antiviral agent plus RBV achieved SVR@-@ of @ ( @ % ) of those receiving SOF , LDV , and RBV and @ of @ ( @ % ) of those receiving SOF , GS-@ , and RBV .


Among cirrhotic prior null responders , SVR@ was achieved by @ ( @ % ) of those receiving SOF , LDV , and RBV and @ ( @ % ) 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 @ infection and in patients that did not respond to previous treatment .


ClinicalTrials.gov ID NCT@ .


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 .


@ 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 = @ , p = @ ) and did not buffer the disability-depression relationship ( B = -@ , SE @ , p = @ ) , strong relationships were found between religious indicators and greater purpose , optimism , generosity , and gratefulness ( F = @ , p < @ ) .


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 @-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 -LSB- SP -RSB- ) .


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 @-minute observational sleep results , standard polysomnography was conducted simultaneously and sleep outcomes for the @ modalities were compared .


In a randomized crossover clinical trial , @ infants , @ @ weeks ' gestational age and @ @ 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 @-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 @-minute intervals and summed over @ 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 = @ ) and fewer state shifts per hour ( r = -@ ) from electroencephalogram ( EEG ) .


Sleep efficiency by EEG was greater on CP versus SP .


The CP enabled sleep compared with the standard mattress ( SP ) over @-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 @ 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 ( @ % ) saline nebulization in these children .


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


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 @ ml normal ( @ % ) saline or hypertonic ( @ % ) 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 @ minutes before each inhalation session .


Bronchiolitis accounted @ % of total admissions .


Their mean age ( SD ) was @ ( @ ) months with range from @ days to @ months .


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


Fifty-seven ( @ % ) children were less than @ months and @ ( @ % ) were @ months - @ months .


The mean ( SD ) for duration of hospital stay was @ ( @ ) and @ ( @ ) for @ % and @ % group respectively ( p = @ ) .


Likewise , mean ( SD ) duration of oxygen supplementation was @ ( @ ) and @ ( @ ) for @ % and @ % group respectively ( p = @ ) .


Moreover , time required for normalization of clinical score was @ ( @ ) and @ ( @ ) for @ % and @ % group respectively ( p = @ ) .


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


The IFCT-GFPC @ 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 @,@ and @,@ euros per quality-adjusted life year ( QALY ) .


Gemcitabine continuation maintenance therapy had a favourable ICER in patients with PS = @ ( @,@ / QALY ) , in responders to induction chemotherapy ( @,@ / QALY ) , regardless of histology ( adenocarcinoma , @,@ / QALY , non adenocarcinoma , @,@ / QALY ) .


Erlotinib maintenance showed a favourable ICER in patients with PS = @ ( @,@ / QALY ) , in patients with adenocarcinoma ( @,@ / QALY ) and in patient with objective response to induction ( @,@ / QALY ) , but it is not cost-effective in patients with PS = @ , 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 @ .


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


Cycle-to-event Cox regression models were used to investigate the association of bevacizumab with the incidence of grade @ or greater ( @ ) 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 @ randomized patients , the odds of experiencing grade @ ATE were significantly greater in those who received bevacizumab compared with those who received placebo ( odds ratio , @ ; P = @ ) , whereas an opposite trend was noted for grade @ VTE ( odds ratio , @ ; P = @ ) .


In the multivariable analysis , bevacizumab treatment ( hazard ratio -LSB- HR -RSB- , @ ; P = @ ) and age ( HR , @ ; P = @ ) were significantly associated with the risk of ATE ; whereas age ( HR , @ ; P = @ ) and VTE risk score ( HR , @ ; P = @ ) 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 , @ men and @ women with a clinical diagnosis of PHP were randomly assigned into MFR or a control group and given @ sessions of treatment per client over @ 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 @ ( pretest score ) , week @ ( posttest score ) , and follow-up at week @ 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 @ and @ ( P < @ ) .


Patients in the MFR and control groups reported a @ % and @ % reduction , respectively , in their pain and functional disability in week @ compared with that in week @ , which persisted as @ % in the follow-up at week @ 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 < @ ) .


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 < @ ) .


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 > @ ) .


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-G@ 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 @ sites in the United States .


RP-G@ or placebo was administered to @ patients with LI for @ days .


Post-treatment , subjects reintroduced dairy into their daily diets and were followed for @ 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-G@ at the end of treatment and @ days post-treatment .


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


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


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


Efficacy trends and favorable safety/tolerability findings suggest that RP-G@ 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 @ 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 , @ patients were enrolled , and @ completed the protocols .


Drug compliance and side effects were similar between the groups .


The intention-to-treat eradication rates were @ % ( @ % confidence interval ( CI ) = @-@ % , @/@ ) in the antimicrobial susceptibility-guided group and @ % ( @ % CI = @-@ @ % , @/@ ) in the clarithromycin-based triple therapy group after the initial treatment ( P = @ ) , whereas the per-protocol ( PP ) eradication rates were @ % ( @ % CI = @-@ % , @/@ ) in the antimicrobial susceptibility-guided group and @ % ( @ % CI = @-@ @ % , @/@ ) in the clarithromycin-based triple therapy group ( P = @ ) .


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


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 : @ ) 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 @ ) 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 @ months .


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


Survey respondents ( N = @ ) will be randomized in a @:@ 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 @ months to assess study outcomes .


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


The primary outcome will be cotinine-validated abstinence at @-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 .


An effective and well tolerated treatment is needed for patients with early HER@-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 @ study that enrolled women ( @ years of age ) with early-stage HER@-positive breast cancer from @ oncology centres in France .


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


Before the first and second cycles , -LSB- ( @ ) F -RSB- - 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 ( @:@ ) to receive four cycles of docetaxel ( @ mg/m ( @ ) intravenously every @ weeks ) and trastuzumab ( @ mg/kg intravenously every @ weeks ) plus bevacizumab ( @ mg/kg intravenously every @ 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 @ .


Survival outcomes are not yet mature .


This study is registered with ClinicalTrials.gov ( NCT@ ) and EUDRACT ( @-@-@ ) .


Between May @ , @ , and Oct @ , @ , @ patients were recruited for the study .


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


Of these @ patients , @ were predicted by -LSB- ( @ ) F -RSB- - FDG PET to be treatment responders after two cycles of treatment .


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


Pathological complete responses were noted in @ ( @ % , @ % CI @-@ ) of the PET responders , @ ( @ % , @-@ ) of those in group A , and six ( @ % , @-@ ) of those in group B. Incidences of grade @-@ adverse events were similar in all three groups .


The most common grade @-@ 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 , @ serious adverse events were reported in @ patients ( PET responders : nine events in four -LSB- @ % -RSB- of @ patients ; group A : @ events in ten -LSB- @ % -RSB- of @ patients ; group B : one event in one -LSB- @ % -RSB- of @ patients ) .


No deaths occurred during the study .


In patients with HER@-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 @ trials .


To describe secondary analyses from a @-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 @ weeks ( n = @ ) , and the other group where the antecedent antipsychotic was abruptly stopped ( n = @ ) .


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 @ and continuing through Week @ .


Discontinuations due to AEs in the first @ weeks of treatment were higher for the immediate-switch group compared with the gradual-switch group ( @ % vs. @ % , NNT @ , @ % CI @-@ ) .


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 @ 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 @ healthy volunteers .


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


Second , @ 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 @ weeks alongside a course of physiotherapy .


At the end of the @ 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 @ to @ and @ to @ years respectively .


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


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


The primary end point was progression-free survival .


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


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


Secondary end points were consistently improved in the VR-CAP group , including the complete response rate ( @ % vs. @ % ) , the median duration of complete response ( @ months vs. @ months ) , the median treatment-free interval ( @ months vs. @ months ) , and the @-year overall survival rate ( @ % vs. @ % ) .


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-@ ClinicalTrials.gov number , NCT@ . )


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 -LSB- PAN -RSB- , granulomatosis with polyangiitis -LSB- Wegnener 's -RSB- -LSB- GPA -RSB- , microscopic polyangiitis -LSB- MPA -RSB- , or eosinophilic GPA -LSB- Churg-Strauss -RSB- -LSB- EGPA -RSB- ) .


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


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


The control treatment included @ months of corticosteroids for all patients , combined with @ mg/m ( @ ) IV CYC pulses , every @-@ 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 @ .


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


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


Secondary outcome measures included remission and relapse rates .


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


Mean SD age at diagnosis was @ @ years .


Analysis at @ years included @ patients ( @ GPA , @ MPA , @ EGPA , and @ PAN ) in the experimental arm and @ patients ( @ GPA , @ MPA , @ EGPA , and @ PAN ) in the conventional arm .


In total , @ ( @ % ) versus @ ( @ % ) had @ SAE ( P = @ ) , most frequently infections ; @ ( @ % ) versus @ ( @ % ) failed to achieve remission ( P = @ ) ; @ ( @ % ) versus @ ( @ % ) died ( P = @ ) ; and @ ( @ % ) of @ versus @ ( @ % ) of @ survivors in remission experienced a relapse ( P = @ ) .


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 @ and @ 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 ( @ ) patients ( @ acupuncture ; @ controls ) were included ( mean age @ years , female @ % ) and were comparable at baseline .


Acupuncture treatment was associated with significantly higher costs compared to control patients ( overall costs : @ -LSB- @ % confidence interval ( CI ) @-@ @ -RSB- versus @ -LSB- @ % CI @-@ @ -RSB- ; p = @ ; asthma-related costs : @ -LSB- @ % CI @-@ @ -RSB- versus @ -LSB- @ % CI @-@ @ -RSB- ; p < @ ) .


These additional costs seem essentially driven by acupuncture costs themselves ( @ -LSB- @ % CI @-@ @ -RSB- ) .


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


Resulting ICER lay between @,@ ( overall ) and @,@ ( diagnosis-specific ) per additional QALY .


When using German acupuncture prices of year @ , the ICER would improve to @ ( overall ) versus @,@ ( 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 @ risk factors for no-reflow .


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


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


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


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


Of @ STEMI patients ( March @ , @ to November @ , @ ) , @ patients ( mean age , @ years ; @ % male ) were randomized ( @ to the deferred stenting group , @ to the immediate stenting ) .


The median ( interquartile range -LSB- IQR -RSB- ) time to the second procedure in the deferred stenting group was @ h ( IQR : @ to @ h ) .


Fewer patients in the deferred stenting group had no - / slow-reflow ( @ -LSB- @ % -RSB- vs. @ -LSB- @ % -RSB- ; p = @ ) , no reflow ( @ -LSB- @ % -RSB- vs. @ -LSB- @ % -RSB- ; p = @ ) and intraprocedural thrombotic events ( @ -LSB- @ % -RSB- vs. @ -LSB- @ % -RSB- ; p = @ ) .


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


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


Myocardial salvage index at @ months was greater in the deferred stenting group ( @ -LSB- IQR : @ % to @ % -RSB- vs. @ -LSB- IQR : @ % to @ % -RSB- ; p = @ -RSB- .


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


( Deferred Stent Trial in STEMI ; NCT@ ) .


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


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