Blind assessment of perceived pain ( visual analog scale -LSB- VAS -RSB- ) during physical therapist palpation of the left and right occipital , upper trapezius , and levator scapulae muscle areas ; self-assessed degree of pain on the Visual , Musculoskeletal , and Balance Complaints questionnaire ; and the Medical Outcomes Study @-Item Short-Form Health Survey bodily pain scale .


Patients undergoing Feldenkrais method reported significantly less pain than the controls according to the VAS and Visual , Musculoskeletal , and Balance Complaints questionnaire ratings at posttreatment follow-up and @-year follow-up .


There were no significant differences regarding the Medical Outcomes Study @-Item Short-Form Health Survey bodily pain scale ratings .


Feldenkrais method is an effective intervention for chronic neck/scapular pain in patients with visual impairment .


Lobeglitazone is a recently approved peroxisome proliferator-activated receptor - agonist for the treatment of type @ diabetes mellitus in Korea .


The purpose of this study was to investigate the pharmaco kinetic properties of lobeglitazone in healthy females and to compare these with historical data in healthy males .


This study was designed as a block-randomized , double-blind , placebo-controlled , parallel-group study .


A single @ or @ mg oral dose of lobeglitazone or a placebo was randomly administered to @ female subjects , and pharmacokinetic blood samples were obtained after dosing .


Pharmacokinetic parameters were calculated by a non-compartmental method , and the results were compared with those previously obtained from male subjects .


Tolerability was assessed by clinical and laboratory parameters .


During the study , a total of @ adverse events ( AEs ) were observed in the lobeglitazone group ( n = @ ) and nine AEs in the placebo group ( n = @ ) .


Serious AEs or significant clinical changes were not observed .


After oral administration , lobeglitazone was rapidly absorbed with the time to maximum plasma concentration ( t ( max ) ) ranging from @ to @ h.


The mean ( standard deviation ) maximum plasma concentration ( C ( max ) ) and area under the plasma concentration-time curve from time zero to infinity ( AUC ( ) ) for the @ mg dose were @ ( @ ) g/L and @,@ ( @ ) gh/L , respectively , and the corresponding values for the @ mg dose were @ ( @ ) g/L and @,@ ( @,@ ) gh/L , respectively .


The ratios ( @ % CIs ) for the geometric means ( female/male ) of the C ( max ) and AUC were @ ( @-@ @ ) and @ ( @-@ @ ) , respectively ( @ mg ) , and @ ( @-@ @ ) and @ ( @-@ @ ) , respectively ( @ mg ) .


Lobeglitazone was well-tolerated in healthy females .


There was no sex difference for systemic lobeglitazone exposure at a @ mg dose ; however , female subjects showed greater systemic exposure than males after the administration of @ mg of lobeglitazone .


In spite of the pharmacokinetic difference , dose adjustment based on sex alone is not needed in clinical use because therapy should be individualized for each patient to achieve glycemic control .


To assess the effect and safety of Jinhua Qinggan Granule ( JHG ) in treating influenza patients of wind-heat affecting Fei syndrome ( WHAFS ) .


Totally @ influenza patients of WHAFS were randomized by stratification into @ groups , the high dose JHG group ( @ cases , @ g each time ) , the low dose JHG group ( @ cases , @ g JHG + @ g placebo each time ) , and the placebo control group ( @ cases , @ g placebo each time ) .


All medication was administered three times daily for @ days .


The fever disappearance time , the fever disappearance rate , efficacy of TCM syndrome , the disappearance rate of main symptoms and physical signs of flu , the negative rate of virus nucleic acid in the pharyngeal secretion , and safety indicators were assessed .


The median fever disappearance time was @ h ( @ % CI : @-@ @ h ) in the high dose JHG group , @ h ( @ % CI : @-@ @ h ) in the low dose JHG group , @ h ( @ % CI : @-@ @ h ) in the placebo control group .


There was statistical difference in the median fever disappearance time between the low dose JHG group and the placebo control group ( P = @ ) .


Three days after treatment , the markedly effective rate of TCM symptoms in the low dose JHG group was @ % , higher than that of the placebo control group ( @ % ) , and its effective rate was superior to that of the high dose JHG group ( P = @ ) .


Five days after treatment , the recovery rate of the low dose JHG group ( @ % ) was higher than that of the high dose JHG group ( @ % , P = @ ) and that of the placebo control group ( @ % , P = @ ) .


The markedly effective rate of the low dose JHG group ( @ % ) was higher than that of the placebo control group ( @ % , P = @ ) .


Similar effects were obtained in the low dose JHG group and the high dose JHG group , but slightly poor in partial indicators of the high dose JHG group .


There was no statistical difference in adverse reaction among these three groups ( P > @ ) .


JHG was effective and safe in treating influenza patients of WHAFS .


Routinely low dose was the optimal dosage of JHG .


To evaluate the effects of golimumab therapy on achieving inactive disease or major improvement , as assessed by the Ankylosing Spondylitis Disease Activity Score ( ASDAS ) , and improvements in health-related quality of life ( HRQOL ) and productivity through @ years in patients with AS .


In the phase III GO-RAISE trial , @ patients were randomized to placebo with crossover to golimumab @ mg at Week @ ( n = @ ) , golimumab @ mg ( n = @ ) , or golimumab @ mg ( n = @ ) at baseline and every @ weeks .


The proportions of patients with ASDAS major improvement ( improvement @ ) or inactive disease ( score < @ ) were determined .


HRQOL was assessed using the @-item Medical Outcomes Study Short Form-@ physical/mental component summary ( SF-@ PCS/MCS ) scores ( normal score @ ) .


The effect of disease on productivity was assessed by visual analog scale ( @-@ ) .


Regression analyses on the association of disease activity and HRQOL were performed .


The final assessment was at Week @ .


Significantly greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease at weeks @ and @ versus placebo .


Through Week @ , patients who achieved ASDAS inactive disease or major improvement had significantly greater improvements in SF-@ PCS and MCS scores and productivity than did patients not meeting these targets .


Among all patients , achieving ASDAS inactive disease at weeks @ and @ was associated with normalized SF-@ PCS/MCS scores and significant improvements in work productivity .


Greater proportions of golimumab-treated patients achieved ASDAS major improvement or inactive disease and improved HRQOL versus placebo .


Achieving an inactive disease state by ASDAS criteria ( < @ ) was associated with normalized HRQOL through @ years .


Training increases the functional use of an upper limb prosthesis , but little is known about how people learn to use their prosthesis .


The aim of this study was to describe the changes in performance with an upper limb myoelectric prosthesis during practice .


The results provide a basis to develop an evidence-based training program .


Thirty-one able-bodied participants took part in an experiment as well as thirty-one age - and gender-matched controls .


Participants in the experimental condition , randomly assigned to one of four groups , practiced with a myoelectric simulator for five sessions in a two-weeks period .


Group @ practiced direct grasping , Group @ practiced indirect grasping , Group @ practiced fixating , and Group @ practiced a combination of all three tasks .


The Southampton Hand Assessment Procedure ( SHAP ) was assessed in a pretest , posttest , and two retention tests .


Participants in the control condition performed SHAP two times , two weeks apart with no practice in between .


Compressible objects were used in the grasping tasks .


Changes in end-point kinematics , joint angles , and grip force control , the latter measured by magnitude of object compression , were examined .


The experimental groups improved more on SHAP than the control group .


Interestingly , the fixation group improved comparable to the other training groups on the SHAP .


Improvement in global position of the prosthesis leveled off after three practice sessions , whereas learning to control grip force required more time .


The indirect grasping group had the smallest object compression in the beginning and this did not change over time , whereas the direct grasping and the combination group had a decrease in compression over time .


Moreover , the indirect grasping group had the smallest grasping time that did not vary over object rigidity , while for the other two groups the grasping time decreased with an increase in object rigidity .


A training program should spend more time on learning fine control aspects of the prosthetic hand during rehabilitation .


Moreover , training should start with the indirect grasping task that has the best performance , which is probably due to the higher amount of useful information available from the sound hand .


There is no consensus about the best option of internal fixation for unstable intertrochanteric fractures .


The aim of the present study was to compare proximal femoral nail ( PFN ) with contralateral reverse distal femoral locking compression plate ( reverse-DFLCP ) in the management of unstable intertrochanteric fractures with compromised lateral wall .


In a randomized controlled study , from November @ to October @ , @ patients with unstable intertrochanteric fractures with compromised lateral wall ( AO @A @ to @ ) had osteosynthesis by PFN ( n = @ ) or reverse-DFLCP ( n = @ ) .


Intra-operative variables compared were duration of surgery , blood loss during surgery , fluoroscopy time and surgeons perception of the surgery .


Patients were followed up clinically for a minimum of one year .


Functional outcome was assessed by Parker Palmer mobility score ( PPMS ) , Harris hip score ( HHS ) , and Short Form-@ .


Failure was defined as any condition which would necessitate revision surgery with change of implant .


Duration of surgery ( p = @ ) , blood loss during surgery ( p = @ ) and fluoroscopy time ( p = @ ) were significantly less in the PFN group than in the reverse-DFLCP group .


No significant difference was found in type of reduction , difficulty in reduction and surgeon 's perception of surgery .


The PFN group had better functional outcome than the reverse-DFLCP group .


HHS for the PFN group was @ @ and for the reverse-DFLCP group it was @ @ ( p = @ ) .


SF-@ physical ( p = @ ) and mental component ( p = @ ) scores in the PFN group was significantly better than in the reverse-DFLCP group .


There was one failure in the PFN group as compared to six in the reverse-DFLCP group ( p = @ ) .


Due to favourable intra-operative variables , better functional outcome and lower failure rates , we conclude that PFN is a better implant than reverse-DFLCP for intertrochanteric fractures with compromised lateral wall .


To determine the incidence of pancreatitis and pancreatic cancer in the SAVOR-TIMI @ trial .


A total of @,@ type @ diabetic patients @ years old with established cardiovascular ( CV ) disease or CV risk factors were randomized to saxagliptin or placebo and followed for @ years .


Outcome measures were investigator reported with blinded expert adjudication of total pancreatitis ( acute and chronic ) and reported cases of pancreatic cancer .


Trial investigators reported @ events of pancreatitis in each treatment arm in @ patients ( @ -LSB- @ % -RSB- in the saxagliptin arm and @ -LSB- @ % -RSB- in control arm ) , with a hazard ratio ( HR ) of @ ( @ % CI @-@ @ , P = @ ) .


Adjudication confirmed pancreatitis in @ patients ( @ events ) in the saxagliptin arm ( @ % ) and @ patients ( @ events ) in placebo arm ( @ % ) , with an HR of @ ( @-@ @ , P = @ ) .


Cases of definite acute pancreatitis were confirmed in @ ( @ % ) vs. @ ( @ % ) ( HR @ -LSB- @-@ @ -RSB- , P = @ ) , definite plus possible pancreatitis in @ vs. @ ( HR @ -LSB- @-@ @ -RSB- , P = @ ) , and chronic pancreatitis in @ vs. @ ( HR @ -LSB- @-@ @ -RSB- , P = @ ) in the saxagliptin and placebo arms , respectively .


No differences in time to event onset , concomitant risk factors for pancreatitis , investigator-reported causality from study medication or disease severity , and outcome were found between treatment arms .


The investigators reported @ and @ cases of pancreatic cancer in the saxagliptin and placebo arms , respectively ( HR @ -LSB- @-@ @ -RSB- , P = @ ) .


In the SAVOR-TIMI @ trial , within @ years of follow-up , risk for pancreatitis in type @ diabetic patients treated with saxagliptin was low and apparently similar to placebo , with no sign of increased risk for pancreatic cancer .


Further studies are needed to completely resolve the pancreatic safety issues with incretin-based therapy .


Most phases @ and @ blinded randomized clinical trials package study drug , e.g. , active and placebo , into drug kits for distribution to investigational sites .


Kits are made so that it is not possible to determine the type of drug in the kit .


This enables investigators to administer drug to patients in a manner that blinds investigators and patients .


Kits are labeled with unique kit IDs that code for the drug type .


Kit lists contain the assignment of kit IDs to drug .


Algorithms for making kit lists , like algorithms for randomizing patients , incorporate randomness to ensure investigators and patients are blind to the process .


This paper reviews three types of kit list : blocked , double randomized , and scrambled , and discusses the operational benefits of what a pharmaceutical company might obtain using scrambled lists along with an overview of the challenges of generating and extending the lists for large trials .


We reviewed the operational characteristics of three types of kit list : blocked , double randomized , and scrambled .


Blocked kit lists were a popular choice until their unblinding and operational deficiencies became well known .


The many difficulties associated with blocked kit lists are unnecessary and can be avoided by using a double randomized kit list or a scrambled kit list .


Compared to double randomized kit lists , scrambled kit lists can be more easily extended due to their advantage of having randomly sized gaps between kit IDs .


Among the three types of kit list , scrambled kit lists offer the most flexibility .


The adoption of scrambled kit lists has in practice provided the many operational benefits described in this paper .


The double-blind phase of the EARLY study of bosentan remains the only randomized controlled trial of a PAH-targeted therapy in World Health Organization functional class ( FC ) II patients .


We report on the efficacy , safety , disease worsening , survival and prognostic factors in mildly symptomatic pulmonary arterial hypertension ( PAH ) patients treated with bosentan in the open-label extension phase of the EARLY study .


Exploratory efficacy outcomes included @-minute walk distance ( @ MWD ) and WHO FC .


Adverse events were recorded .


Kaplan-Meier analysis was used to estimate time to first PAH worsening event ( death , initiation of intravenous or subcutaneous prostanoids , atrial septostomy or lung transplantation ) and survival .


Cox regression analysis determined factors prognostic of survival .


Median exposure to bosentan ( n = @ ) was @ months .


At the end of the bosentan-treatment assessment period , @ % of patients were in WHO FC I/II .


Adverse events led to discontinuation of bosentan in @ % of patients .


Aminotransferase elevations > @ upper limit of normal occurred in @ % .


Four-year PAH-event-free survival and survival were @ % ( @ % confidence intervals -LSB- @ % CI -RSB- @ , @ ) and @ % -LSB- @ % CI @ , @ -RSB- , respectively .


Low @ MWD , low mixed venous oxygenation , high N-terminal pro hormone of brain natriuretic peptide levels and PAH associated with connective tissue disease were associated with a higher risk of death .


The majority of patients exposed to long-term bosentan maintained or improved their functional class .


Approximately @ % of the patients discontinued treatment because of adverse events , which were most commonly PAH worsening and elevated liver enzymes .


Pipecuronium is a steroidal neuromuscular blocking agent .


Sugammadex , a relaxant binding - cyclodextrin derivative , reverses the effect of rocuronium , vecuronium , and pancuronium .


We investigated whether sugammadex reverses moderate pipecuronium-induced neuromuscular blockade ( NMB ) and the doses required to achieve reversal .


This single-center , randomized , double-blind , @-group parallel-arm study comprised @ patients undergoing general anesthesia with propofol , sevoflurane , fentanyl , and pipecuronium .


Neuromuscular monitoring was performed with acceleromyography ( TOF-Watch SX ) according to international standards .


When the NMB recovered spontaneously to train-of-four count @ , patients randomly received @ , @ , @ , or @ mg/kg of sugammadex or placebo .


Recovery time from sugammadex injection to normalized train-of-four ( TOF ) ratio @ was the primary outcome variable .


The recovery time from the sugammadex injection to final T@ was the secondary end point .


Postoperative neuromuscular functions were also assessed .


Each patient who received sugammadex recovered to a normalized TOF ratio of @ within @ minutes ( @ % lower confidence interval for the lowest dose @ % ; for all doses @ % ) and @ % of these patients reached a normalized TOF ratio @ within @ minutes ( @ % lower confidence interval for the lowest dose @ % ; for all doses @ % ) .


T@ recovered several minutes after the TOF ratio .


No residual postoperative NMB was observed .


Sugammadex adequately and rapidly reverses pipecuronium-induced moderate NMB during sevoflurane anesthesia .


Once the train-of-four count has spontaneously returned to @ responses following pipecuronium administration , a dose of @ mg/kg of sugammadex is sufficient to reverse the NMB .


Exposure to household air pollution ( HAP ) causes @ million deaths annually , and strategies to reduce HAP exposure are urgently required .


To evaluate the acceptability and feasibility of conducting a trial of a cookstove intervention in rural Malawi .


Non-smoking women were randomised to continuing to use an open fire ( control ) or to using a wood-burning clay cookstove ( intervention ) .


Symptom burden , oxygen saturation and exhaled carbon monoxide ( eCO ) were assessed at baseline and @-day follow-up .


A subset of women underwent HAP exposure monitoring .


Of @ women recruited , @ ( @ % ) completed the main study .


The methodology was acceptable to participants .


Headache , back pain and cough were the most commonly reported symptoms at baseline and follow-up .


Median eCO was within normal limits , but with a difference of @ parts per million ( ppm ) in median change of eCO from baseline to follow-up seen between the two groups ( P = @ ) .


The peak ambient CO concentration detected was @ ppm .


This study suggests that a large cookstove intervention trial in Malawi would be feasible with careful community sensitisation .


Monitoring exposure to HAP is challenging , and further studies evaluating potential biomarkers of exposure , including eCO , should be undertaken .


In schizophrenia , sex specific dimorphisms related to age of onset , course of illness and response to antipsychotic treatment may be mirrored by sex-related differences in the underlying molecular pathways .


Here , we have carried out multiplex immunoassay profiling of sera from @ independent cohorts of first episode antipsychotic naive schizophrenia patients ( n = @ ) and controls ( n = @ ) to identify such sex-specific illness processes in the periphery .


The concentrations of @ molecules associated with hormonal , inflammation and growth factor pathways showed significant sex differences in schizophrenia patients compared with controls .


In female patients , the inflammation-related analytes alpha-@-antitrypsin , B lymphocyte chemoattractant BLC and interleukin-@ showed negative associations with positive and negative syndrome scale ( PANSS ) scores .


In male patients , the hormones prolactin and testosterone were negatively associated with PANSS ratings .


In addition , we investigated molecular changes in a subset of @ patients before and after @ weeks of treatment with antipsychotics and found that treatment induced sex-specific changes in the levels of testosterone , serum glutamic oxaloacetic transaminase , follicle stimulating hormone , interleukin-@ and macrophage-derived chemokine .


Finally , we evaluated overlapping and distinct biomarkers in the sex-specific molecular signatures in schizophrenia , major depressive disorder and bipolar disorder .


We propose that future studies should investigate the common and sex-specific aetiologies of schizophrenia , as the current findings suggest that different therapeutic strategies may be required for male and female patients .


The efficacy of concomitant ablation techniques in patients with paroxysmal atrial fibrillation ( AF ) undergoing mitral valve surgery remains under debate .


The aim of this prospective , randomized , single-centre study was to compare pulmonary vein isolation ( PVI ) only versus a left atrial maze ( LAM ) procedure in patients with paroxysmal AF during mitral valve surgery .


Between February @ and June @ , @ patients with a mean age of @ ( standard deviation @ years ) underwent mitral valve surgery and concomitant bipolar radiofrequency ablation for paroxysmal AF .


Patients were randomized into the PVI group ( n = @ ) and the LAM group ( n = @ ) .


After surgery , an implantable loop recorder for continuous electrocardiography ( ECG ) monitoring was implanted .


Patients with an AF burden ( AF % ) of < @ % were considered AF free ( responders ) .


The mean follow-up was @ months ( standard deviation @ months ) , and the patient ' data were evaluated every @ months .


All patients were alive at discharge .


No procedure-related complications occurred for either the ablation or the loop recorder implantation .


Mean aortic clamping and ablation times were significantly longer in the LAM group than in the PVI group .


The incidence of early AF paroxysm recurrence was significantly higher in the PVI group than in the LAM group ( @ vs @ % , P < @ ) .


At @ months after surgery , @ ( @ % ) of the @ patients in the PVI group and @ ( @ % ) of the @ patients in the LAM group had no documented atrial arrhythmias and were considered responders ( AF burden < @ % ) .


The mean AF burden during all follow-up periods was significantly lower in the LAM group ( @ @ % ) than in the PVI group ( @ @ % ) ( P < @ ) .


According to continuous ECG monitoring data , freedom from AF was significantly higher after the concomitant LAM procedure than after PVI in patients with paroxysmal AF who underwent mitral valve surgery .


Stroke survivors represent a target population in need of intervention strategies to promote cognitive function and prevent dementia .


Both exercise and recreational activities are promising strategies .


We assessed the effect of a @-month exercise and recreation program on executive functions in adults with chronic stroke .


A @-month ancillary study within a multicentre randomized trial .


Twenty-eight chronic stroke survivors ( ie , @ months since an index stroke ) were randomized to @ of @ experimental groups : intervention ( INT ; n = @ ) or delayed intervention ( D-INT ; n = @ ) .


Participants of the INT group received a @-month community-based structured program that included @ sessions of exercise training and @ session of recreation and leisure activities per week .


Participants of the D-INT group received usual care .


The primary outcome measure was the Stroop Test , a cognitive test of selective attention and conflict resolution .


Secondary cognitive measures included set shifting and working memory .


Mood , functional capacity , and general balance and mobility were additional secondary outcome measures .


Compared with the D-INT group , the INT group significantly improved selective attention and conflict resolution ( P = @ ) , working memory ( P = @ ) , and functional capacity ( P = @ ) at the end of the @-month intervention period .


Improved selective attention and conflict resolution was significantly associated with functional capacity at @ months ( r = @ ; P = @ ) .


This is the first randomized study to demonstrate that an exercise and recreation program can significantly benefit executive functions in community-dwelling chronic stroke survivors who are mildly cognitively impaired-a population at high-risk for dementia and functional decline .


Thus , clinicians should consider prescribing exercise and recreational activities in the cognitive rehabilitation of chronic stroke survivors .


This report describes the results of an analysis of patient-reported outcomes from EMILIA ( TDM@g/BO@ ) , a randomized phase @ study of the antibody-drug conjugate trastuzumab emtansine ( T-DM@ ) versus capecitabine and lapatinib in human epidermal growth factor receptor @ ( HER@ ) - positive locally advanced or metastatic breast cancer .


A secondary endpoint of the EMILIA study was time to symptom worsening ( time from randomization to the first documentation of a @-point decrease from baseline ) as measured by the Trial Outcome Index Physical/Functional/Breast ( TOI-PFB ) subset of the Functional Assessment of Cancer Therapy-Breast questionnaire .


Predefined exploratory patient-reported outcome endpoints included proportion of patients with a clinically significant improvement in symptoms ( per TOI-PFB ) and proportion of patients with diarrhea symptoms ( per Diarrhea Assessment Scale ) .


In the T-DM@ arm , @ of @ patients had a baseline and @ postbaseline TOI-PFB score versus @ of @ patients in the capecitabine-plus-lapatinib arm .


Time to symptom worsening was delayed in the T-DM@ arm versus the capecitabine-plus-lapatinib arm ( @ months versus @ months , respectively ; hazard ratio = @ ; P = @ ) .


In the T-DM@ arm , @ % of patients developed clinically significant improvement in symptoms from baseline versus @ % in the capecitabine-plus-lapatinib arm ( P = @ ) .


Although similar at baseline , the number of patients reporting diarrhea symptoms increased @ - to @-fold during treatment with capecitabine and lapatinib but remained near baseline levels in the T-DM@ arm .


Together with the EMILIA primary data , these results support the concept that T-DM@ has greater efficacy and tolerability than capecitabine plus lapatinib , which may translate into improvements in health-related quality of life .


To examine the effects of an individualized outdoor activity intervention carried out by volunteers on depressive symptoms among community-living older people with severe mobility limitations who have difficulties accessing the outdoors independently .


Secondary analyses of the ` Volunteering , Access to Outdoor Activities and Wellbeing in Older People ' ( VOW ) data ( ISRCTN@ ) .


VOW was a randomized single blinded two-arm controlled trial conducted in Jyvskyl , Finland , in @-@ .


At baseline , @ people aged @-@ years with severe mobility limitations were interviewed at home and randomized into either an intervention or waiting list control group .


Volunteers ( n = @ ) had retired from regular work and were trained for the study .


A volunteer assisted the participant in attending recreational out-of-home activities once a week for three months .


Depressive symptoms were assessed using the Center for the Epidemiological Studies Depression Scale ( CES-D ) .


In the intervention group the CES-D score did not change during the intervention ( from @ standard error @ to @ @ ) , while in the control group it increased from @ @ to @ @ ( intervention effect p = @ ) .


Among the subgroups with minor depressive symptoms at baseline ( CES-D score @-@ ) , the CES-D score decreased in the intervention group and increased in the control group ( p = @ ) .


A three-month outdoor activity intervention may improve mood among older people with severe mobility limitations .


More randomized controlled trials of the topic are needed .


We aimed to determine the efficacy of fennel and low-dose combined oral contraceptive ( LD-COC ) on inducing menstrual bleeding and method continuation in women using depot medroxyprogesterone acetate ( DMPA ) who had no menstrual bleeding within the previous @ to @ days .


In this double-blind double-dummy trial , @ married women referred to public health centers in Hamadan , Iran , who complained of menstrual cessation induced by DMPA were randomly assigned into fennel , LD-COC or placebo groups with an allocation ratio of @:@:@ .


All participants received two fennel or placebo capsules and one placebo or LD-COC pill daily for @ days .


We evaluated menstrual bleeding using the Higham pictorial chart within @ days following initiating intervention .


Data were analyzed using chi-square or analysis of variance .


There was no loss to follow-up .


Significantly more women in the fennel ( @ % ) and LD-COC ( @ % ) groups experienced menstrual bleeding compared to the placebo ( @ % ) group -LSB- relative risk ( RR ) @ , @ % confidence interval ( CI ) @ to @ ; RR @ , @ % CI @ to @ , respectively -RSB- .


Mean amount of menstrual bleeding among those who experienced menstruation was significantly higher in the fennel group ( @ cc ) than both the LD-COC ( @ cc ) and placebo ( @ cc ) groups .


Also , women using fennel ( @ % ) and LD-COC ( @ % ) were significantly more likely than those using placebo ( @ % ) to have subsequent DMPA injection -LSB- RR @ ( @ % CI @ to @ ) and RR @ ( @ % CI @ to @ ) , respectively -RSB- .


Fennel and LD-COC can resolve DMPA-induced amenorrhea and increase continuation rate of this contraceptive method .


Buprenorphine pharmacotherapy for opioid-dependent pregnant women is associated with maternal and neonatal outcomes superior to untreated opioid dependence .


However , the literature is inconsistent regarding the possible existence of a dose-response relationship between maternal buprenorphine dose and neonatal clinical outcomes .


The present secondary analysis study ( @ ) examined the relationship between maternal buprenorphine dose at delivery and neonatal abstinence syndrome ( NAS ) peak score , estimated gestational age at delivery , Apgar scores at @ and @ min , neonatal head circumference , length , and weight at birth , amount of morphine needed to treat NAS , duration of NAS treatment , and duration of neonatal hospital stay and ( @ ) compared neonates who required pharmacotherapy for NAS to neonates who did not require such pharmacotherapy on these same outcomes , in @ opioid-dependent pregnant women receiving buprenorphine as participants in a randomized clinical trial .


( @ ) Analyses failed to provide evidence of a relationship between maternal buprenorphine dose at delivery and any of the @ outcomes ( all p-values > @ ) and ( @ ) significant mean differences between the untreated ( n = @ ) and treated ( n = @ ) for NAS groups were found for duration of neonatal hospital stay and NAS peak score ( both p-values < @ ) .


( @ ) Findings failed to support the existence of a dose-response relationship between maternal buprenorphine dose at delivery and any of @ neonatal clinical outcomes , including NAS severity and ( @ ) that infants treated for NAS had a higher mean NAS peak score and , spent a longer time in the hospital than did the group not treated for NAS is unsurprising .


Pulse frequency is one of the key determinants of analgesic outcomes by transcutaneous electrical nerve stimulation ( TENS ) .


However , optimal settings remain unclear .


To compare the effects of different frequencies of TENS , on pressure pain threshold and tolerance .


Currents with pulse duration of @ s , and pulse frequencies of @ pps or @ pps were applied on the volar aspects of the dominant forearms of @ healthy volunteers , on two consecutive days , in a randomized order .


Threshold and tolerance were measured at the beginning , after the @th and @th minutes of the applications , and @ minutes after the applications .


Pressure pain threshold and tolerance values were higher at the @ pps frequency , at all measurement times ( p < @ ) .


However , no frequencyXtime interaction and time-dependent changes were found for the outcome measures ( p > @ ) .


These findings established that , at @ pps conventional TENS , threshold and tolerance values were consistently higher .


These results are presented to inform future research regarding optimal conventional TENS parameters and to provide support for clinical applications .


Disease relapses are frequent in antineutrophil cytoplasmic antibody-associated vasculitis ( AAV ) .


This study was undertaken to evaluate outcomes in patients with AAV who are re-treated with rituximab ( RTX ) and prednisone for severe disease relapses .


The Rituximab in AAV trial was a randomized , double-blind , placebo-controlled trial comparing the rates of remission induction among patients treated with RTX ( n = @ ) and patients treated with cyclophosphamide ( CYC ) followed by azathioprine ( AZA ) ( n = @ ) .


Prednisone was tapered to discontinuation after @ months .


After remission was achieved , patients who experienced a severe disease relapse between months @ and @ were eligible to receive RTX and prednisone on an open-label basis according to a prespecified protocol .


Investigators remained blinded with regard to the original treatment assignment .


Twenty-six patients received RTX for disease relapse after remission had initially been achieved with their originally assigned treatment .


Fifteen of these patients were initially randomized to receive RTX and @ to receive CYC/AZA .


Thirteen ( @ % ) of the patients originally assigned to receive RTX and @ ( @ % ) originally assigned to receive CYC/AZA achieved remission again with open-label RTX ( an overall percentage of @ % ) .


In half of the patients treated with open-label RTX , prednisone could be discontinued entirely .


Patients in this cohort experienced fewer adverse events compared to the overall study population ( @ adverse events per patient-year versus @ adverse events per patient-year ) .


Re-treatment of AAV relapses with RTX and glucocorticoids appears to be a safe and effective strategy , regardless of previous treatment .


To determine inter-observer and inter-examination variability for aortic valve calcification ( AVC ) and mitral valve and annulus calcification ( MC ) in low-dose unenhanced ungated lung cancer screening chest computed tomography ( CT ) .


We included @ lung cancer screening trial participants who were examined by CT twice within @ months to follow indeterminate pulmonary nodules .


On these CTs , AVC and MC were measured in cubic millimetres .


One hundred CTs were examined by five observers to determine the inter-observer variability .


Reliability was assessed by kappa statistics ( ) and intra-class correlation coefficients ( ICCs ) .


Variability was expressed as the mean difference standard deviation ( SD ) .


Inter-examination reliability was excellent for AVC ( = @ , ICC = @ ) and MC ( = @ , ICC = @ ) .


Inter-examination variability was @ mm ( @ ) for AVC and @ mm ( @ ) for MC .


Inter-observer reliability ranged from = @ to = @ for AVC and from = @ to = @ for MC .


Inter-observer ICC was @ for AVC and ranged from @ to @ for MC .


Inter-observer variability ranged from -@ mm ( @ ) to @ mm ( @ ) for AVC and from -@ mm ( @ ) to @ mm ( @ ) for MC .


AVC can be quantified with excellent reliability on ungated unenhanced low-dose chest CT , but manual detection of MC can be subject to substantial inter-observer variability .


Lung cancer screening CT may be used for detection and quantification of cardiac valve calcifications .


Low-dose unenhanced ungated chest computed tomography can detect cardiac valve calcifications .


However , calcified cardiac valves are not reported by most radiologists .


Inter-observer and inter-examination variability of aortic valve calcifications is sufficient for longitudinal studies .


Volumetric measurement variability of mitral valve and annulus calcifications is substantial .


To assess whether physical activity is a risk factor for amyotrophic lateral sclerosis ( ALS ) .


From February @ to April @ , @ patients with ALS from European population-based registries ( France , Ireland , Italy , United Kingdom , Serbia ) and @,@ population controls ( matched for age , sex , and residency ) were assessed .


Upon direct interview , data were collected on occupation and history of sport and leisure activities , physical activity , and accidental injuries .


Physical exercise was defined as having spent time doing activities that caused an individual to breath hard at least once per month and was coded as none , job-related , and/or sport-related .


Sport-related and work-related physical exercise were quantified using metabolic equivalents ( METs ) .


Risks were calculated using conditional logistic regression models ( adjusting for age , country , trauma , and job-related physical activity ) and expressed as odds ratios ( ORs ) and adjusted ORs ( Adj ORs ) with @ % confidence intervals ( CIs ) .


Overall physical activity was associated with reduced odds of having ALS ( Adj OR = @ , @ % CI = @-@ @ ) as were work-related physical activity ( Adj OR = @ , @ % CI = @-@ @ ) and organized sports ( Adj OR = @ , @ % CI = @-@ @ ) .


An inverse correlation was observed between ALS , the duration of physical activity ( p = @ ) , and the cumulative MET scores , which became significant for the highest exposure ( Adj OR = @ , @ % CI = @-@ @ ) .


An inverse correlation between ALS and sport was found in women but not in men , and in subjects with repeated traumatic events .


Physical activity is not a risk factor for ALS and may eventually be protective against the disease .


Patients with schizophrenia are characterized by high prevalence rates and chronicity that often leads to long-term institutionalization .


Under the traditional medical model , treatment usually emphasizes the management of psychotic symptoms through medication , even though anti-psychotic drugs are associated with severe side effects , which can diminish patients ' physical and psychological well-being .


Tai-chi , a mind-body exercise rooted in Eastern health philosophy , emphasizes the motor coordination and relaxation .


With these potential benefits , a randomized controlled trial ( RCT ) is planned to investigate the effects of Tai-chi intervention on the cognitive and motor deficits characteristic of patients with schizophrenia .


A @-arm RCT with waitlist control design will be used in this study .


One hundred and fifty three participants will be randomized into ( i ) Tai-chi , ( ii ) exercise or ( iii ) waitlist control groups .


Participants in both the Tai-chi and exercise groups will receive @-weeks of specific intervention , in addition to the standard medication and care received by the waitlist control group .


The exercise group will serve as a comparison , to delineate any unique benefits of Tai-chi that are independent of moderate aerobic exercise .


All three groups will undergo three assessment phases : ( i ) at baseline , ( ii ) at @ weeks ( post-intervention ) , and ( iii ) at @ weeks ( maintenance ) .


All participants will be assessed in terms of symptom management , motor coordination , memory , daily living function , and stress levels based on self-perceived responses and a physiological marker .


Based on a promising pilot study conducted prior to this RCT , subjects in the Tai-chi intervention group are expected to be protected against deterioration of motor coordination and interpersonal functioning .


They are also expected to have better symptoms management and lower stress level than the other treatment groups .


Pancreatic exocrine insufficiency is a significant problem after acute pancreatitis .


To evaluate whether oral pancreatic enzyme supplementation improves the recovery of pancreatic exocrine function and to explore the efficacy , safety and tolerability of pancreatic enzyme supplementation in patients during the refeeding period after acute pancreatitis .


Prospective double-blind , placebo controlled , randomized study .


The sudy included @ patients with acute pancreatitis .


Primary efficacy variable was recovery from pancreatic exocrine insufficiency .


Secondary objectives were body weight , abdominal pain , course of APACHE II score , patient 's symptoms and quality of life .


Twenty of the @ patients showed low fecal elastase values indicating pancreatic exocrine insufficiency after acute pancreatitis .


Median time to recovery from exocrine pancreatic insufficiency was @ days in the enzyme supplementation group and @ days in the placebo group but overall differences for primary and all but one secondary endpoint did not reach statistical significance .


However , a positive tendency in favour of enzyme supplementation was found for quality of life parameters ( FACT-Pa ) in all subscores .


There were no relevant differences between placebo and oral pancreatic enzyme supplementation detected with respect to safety and tolerability .


Enzyme supplementation positively effects the course of acute pancreatitis if administered during the early refeeding phase after acute pancreatitis .


There is evidence that oral pancreatic enzyme supplementation has a positive impact on the course of the disease and the global health status ( less weight loss , less flatulence , improved quality of life ) .


Oral pancreatic enzyme supplementation was safely administered and can be added to the treatment regimen of patients in a refeeding status after severe acute pancreatitis .


Incisional pain is the main obstacle for elective laparoscopic cholecystectomy as an outpatient .


We evaluated the analgesic efficacy of local infiltration of ropivacaine with dexamethasone ( Rop/Dx ) , compared with ropivacaine ( Rop ) alone , during the first @ hours postoperative of this surgery .


Our hypothesis is that incisional pain intensity will be lower in patients of the group Rop/Dx .


In a randomized , controlled , double-blind trial clinical , @ patients were divided into two groups .


Group Rop ( n = @ ) received pre and post-incisional infiltration with @ mg of ropivacaine in @ mL of @ % saline , while group Rop/Dx ( n = @ ) received @ mg of ropivacaine with @ mg of dexamethasone in @ mL of @ % saline .


The intensity of pain at rest and movement was assessed at @ , @ , @ , @ and @ hours postoperatively by a numerical rating scale of @ points .


Incisional pain scores in group Rop/Dx were significantly lower , compared to the group Rop , at @ hours ( p = @ ) and @ hours ( p = @ ) at rest and at @ hours ( p = @ ) and @ hours ( p = @ ) during movement postoperatively .


We found initial evidence that ropivacaine with dexamethasone for local infiltration decreased incisional pain intensity after @ hours post-elective laparoscopic cholecystectomy with a good safety profile .


IL-@ expression is increased in psoriatic lesions and might regulate TH@ T-cell counts in patients with psoriasis .


We sought to test a novel IL-@-specific therapeutic agent for the treatment of psoriasis .


In this randomized , double-blind , placebo-controlled study the safety , tolerability , and clinical response of guselkumab , an anti-IL-@-specific mAb , were evaluated in patients with moderate-to-severe plaque psoriasis .


A total of @ patients were randomized to receive a single dose of placebo or @ , @ , @ , or @ mg of guselkumab .


Clinical response was assessed by using the Psoriasis Area and Severity Index ( PASI ) .


Additionally , histologic analysis and gene expression in skin biopsy specimens from guselkumab-treated patients were compared with those from placebo-treated patients .


At week @ , @ % ( @ mg ) , @ % ( @ and @ mg ) , and @ % ( @ mg ) of guselkumab-treated patients , respectively , achieved a @ % improvement in PASI scores from baseline compared with @ % of placebo-treated patients .


Improvements in PASI scores were generally maintained through week @ in all guselkumab-treated patients .


The proportion of patients experiencing an adverse event was comparable between the combined guselkumab ( @/@ -LSB- @ % -RSB- ) and placebo ( @/@ -LSB- @ % -RSB- ) groups through week @ .


Analysis of lesional and nonlesional skin biopsy specimens demonstrated decreases in epidermal thickness and T-cell and dendritic cell expression in guselkumab-treated patients compared with values seen in placebo-treated patients .


At week @ , significant reductions in psoriasis gene expression and serum IL-@A levels were observed in guselkumab-treated patients .


IL-@ inhibition with a single dose of guselkumab results in clinical responses in patients with moderate-to-severe psoriasis , suggesting that neutralization of IL-@ alone is a promising therapy for psoriasis .


Stroke leads to transient immunedepression , which leads to increased incidence of poststroke infections .


Because infection is one of the most common causes of increased mortality in patients with stroke , this study was undertaken to document immunedepression after stroke in our population .


A case-controlled study wherein @ patients with acute ischemic stroke in the age group of @ and @ years without any evidence of previous immunedepression were included .


Interleukin @ ( IL-@ ) and interleukin @ ( IL-@ ) levels were checked in plasma in both the groups on day @ and day @ .


Also Cortisol and epinephrine levels were checked in the urine samples collected on day @ and day @ .


No significant difference was seen between the IL-@ and the IL-@ levels in samples collected on day @ between the controls and cases , whereas Cortisol and norepinephrine were significantly raised in samples collected on day @ in cases who developed infection as compared with controls .


The higher levels of urinary cortisol and norepinephrine were observed in patients with stroke who developed infections , which indirectly reflected increased amount of stroke related stress .


Furthermore , the levels of plasma IL-@ and IL-@ were also elevated in the same group of patients , which means transformation of immunecompetence to immunedepression , which is responsible for higher mortality .


Subsequently on recovery from infection the plasma levels of interleukins and urinary cortisol and norepinephrine did not show any difference , which indirectly means recovery of the immune system on recovery from acute stage of stroke .


Mortality in the patients with infection was increased than controls .


Variations in ` slope ' ( how steep or flat the ground is ) may be good for health .


As walking up hills is a physiologically vigorous physical activity and can contribute to weight control , greater neighbourhood slopes may provide a protective barrier to weight gain , and help prevent Type @ diabetes onset .


We explored whether living in ` hilly ' neighbourhoods was associated with diabetes prevalence among the Australian adult population .


Participants ( @ years ; n = @,@ ) who completed the Western Australian Health and Wellbeing Surveillance System Survey ( @-@ ) were asked whether or not they had medically-diagnosed diabetes .


Geographic Information Systems ( GIS ) software was used to calculate a neighbourhood mean slope score , and other built environment measures at @ m around each participant 's home .


Logistic regression models were used to predict the odds of self-reported diabetes after progressive adjustment for individual measures ( i.e. , age , sex ) , socioeconomic status ( i.e. , education , income ) , built environment , destinations , nutrition , and amount of walking .


After full adjustment , the odds of self-reported diabetes was @ ( @ % CI @-@ @ ) and @ ( @ % CI @-@ @ ) for adults living in neighbourhoods with moderate and higher levels of slope , respectively , compared with adults living in neighbourhoods with the lowest levels of slope .


The odds of having diabetes was @ % lower ( odds ratio @ ; @ % CI @-@ @ ) for each increase of one percent in mean slope .


Living in a hilly neighbourhood may be protective of diabetes onset or this finding is spurious .


Nevertheless , the results are promising and have implications for future research and the practice of flattening land in new housing developments .


The triage of human papillomavirus ( HPV ) - positive women is needed to avoid overreferral to colposcopy .


p@ ( INK@a ) immunostaining is an efficient triage method .


p@ ( INK@a ) / Ki-@ dual staining was introduced mainly to increase reproducibility and specificity compared with stand-alone p@ ( INK@a ) staining .


Within a pilot project , HPV-positive women were referred to colposcopy if cytology was abnormal or unsatisfactory or HPV testing was still positive after @ year .


For @ consecutive women , a slide obtained during colposcopy was immunostained for p@ ( INK@a ) / Ki-@ and independently interpreted by @ readers without previous experience with dual staining .


Four of these readers were experts in cervical pathology and @ were not .


Kappa values for multiple raters , sensitivity , and specificity for cervical intraepithelial neoplasia type @-positive histology were computed .


Because women with normal cytology were underrepresented , estimates for all HPV-positive women were obtained as weighted means of cytology-specific estimates .


The overall kappa for HPV-positive women was @ ( @ % confidence interval -LSB- @ % CI -RSB- , @-@ @ ) .


Kappa values were not found to be significantly different between expert and nonexpert readers with regard to cervical cytology but were significantly increased ( P = .


@ ) after consensus discussion .


The overall specificity estimate for HPV-positive women was @ % ( @ % CI , @ % -@ % ) : @ % ( @ % CI , @ % -@ % ) for experts and @ % ( @ % CI , @ % -@ % ) for nonexperts .


Among women with abnormal cytology , the sensitivity was @ % ( @ % CI , @ % -@ % ) : @ % ( @ % CI , @ % -@ % ) for experts and @ % ( @ % CI , @ % -@ % ) for nonexperts .


p@ ( INK@a ) / Ki-@ immunostaining demonstrated good reproducibility and specificity when triaging HPV-positive women .


Dual-staining interpretation can be performed , after short training , even by staff who are not experts in cervical cytology .


This allows HPV-based screening with triage to be performed in settings in which such expert staff is not available .


The primary objective of the following study is to determine and secondary objective is to compare the efficacy and safety of @ % amlexanox oral paste in the treatment of recurrent minor aphthous ulcers and also to evaluate the recurrence rate of aphthous ulcers over a period of @ year .


The present study was conducted on @ patients diagnosed to have recurrent minor aphthous ulcers of which , @ patients were advised to apply @ % amlexanox oral paste directly on the ulcer @ times a day for @ days and the other @ patients were given placebo paste for the same duration .


The baseline parameters were recorded on the first visit which includes ulcer size , pain , erythema and exudation .


Efficacy and safety evaluations were made on the @ th day and @ th day .


In total @ patients with increased frequency of ulcers were advised to use @ % amlexanox paste for one whole year and the number of ulcers per month was recorded to evaluate any decrease in the recurrence rate .


Male patients dominated the study with @ males and @ females .


The mean age of the total sample was @ years .


The amlexanox group showed marked reduction in ulcer size ( P < @ ) , significant reduction in the visual analog scale scores of pain ( P < @ ) , significant lower scores of erythema and exudation ( P < @ ) when compared to the placebo group on the @ th day of follow-up .


The incidence of recurrence of ulcers was significantly reduced up to the @ th month , but thereafter recurrence rate slowly increased .


Almost @ % of Amlexanox oral paste is clinically beneficial in reducing the pain , erythema , exudation and size of the ulcer over a period of @ days .


There was no definite conclusion drawn with respect to its effect on the recurrence rate of aphthous ulcers over a period of @ year .


To compare the pharmacokinetic profiles and to assess bioequivalence of a newly developed orally soluble film formulation of sildenafil , taken without water , with those of a conventional formulation of sildenafil .


This study was conducted in a population of healthy subjects as an open-label , randomized sequence , two-period , two-formulation , single-dose , crossover design .


The subjects were randomly assigned to @ of @ sequences of the two formulations : an orally soluble film ( OSF ) of @ mg sildenafil as the test drug and a film-coated tablet ( FCT ) of @ mg sildenafil as the reference drug .


Blood samples were collected at intervals from @ to @ hours after administration .


Plasma concentrations of sildenafil and its active metabolite N-desmethyl sildenafil were analyzed using a liquid chromatography/tandem mass spectrometry method .


@ healthy male subjects completed the study .


The geometric mean ( CV % ) for Cmax in the OSF and FCT formulations were @ ( @ % ) ng/mL and @ ( @ % ) ng/mL , respectively .


The geometric mean for AUClast in the OSF and FCT formulations were @ ( @ % ) ng x h/mL and @ ( @ % ) ng x h/mL , respectively .


The geometric mean for AUCinf in the OSF and FCT formulations were @ ( @ % ) ng x h/mL and @ ( @ % ) ng x h / mL , respectively .


The @ % confidence intervals of the ratios of the geometric means of the Cmax , AUClast , and AUCinf were @ - @ , @ - @ , and @ - @ , respectively .


The OSF sildenafil formulation exhibited no significant differences in its pharmacokinetics compared with those of the FCT formulation .


Therefore this convenient OSF sildenafil formulation , which can be taken without the need for water or chewing , offers physicians a novel and attractive treatment option for men with erectile dysfunction .


* These authors contributed equally to this work .


To explore the efficacy , mechanism and safety of silibinin combined with Ruangan pills ( a Chinese herbal preparation ) in the treatment of schistosomiasis liver fibrosis .


A total of @ patients with schistosomiasis liver fibrosis were randomly divided into a control group and a treatment group , and @ patients in each group were respectively administered with oral silibinin alone and oral silibinin combined with Ruangan pills , respectively .


The curative effects in the two groups were evaluated in @ months , @ months , @ months and @ months respectively .


The common five clinical symptoms of schistosomiasis liver fibrosis patients significantly relieved in the treatment group @ months after the therapy , and the total efficiency reached more than @ % , which were significantly higher than that in the control group .


In the treatment group and the control group , there was no improvement in the liver B ultrasonic classification @ months and @ months after the therapy ( P > @ ) ; however , in @ months and @ months , the liver B ultrasonic classification in the treatment group was better than that in the control group ( P < @ , P < @ , respectively ) .


For the four serum indexes of liver fibrosis , there was no significant differences between the two groups in @ months , however , in @ months , @ months , and @ months , there was a significant improvement in the treatment group compared with the control group .


There were no obviously adverse effects in two groups .


Silibinin combined with Ruangan pills has a better curative effect in the treatment of schistosomiasis liver fibrosis .


Airway inflammation persists after smoking cessation in established chronic obstructive pulmonary disease ( COPD ) , suggesting that other factors drive the airway inflammatory response .


We tested the hypothesis that high levels of bacterial colonization are associated with increased levels of neutrophilic airway inflammation in stable COPD by examining the cross-sectional relationship between these measurements and by conducting a randomized , double-blind , placebo-controlled study of the effect of levofloxacin in patients with stable COPD .


Patients were randomized to receive either levofloxacin @ mg daily or placebo for @ days and underwent sputum induction for a differential cell count and quantitative bacterial analysis at baseline and at days @ , @ , and @ .


Sputum percentage neutrophil count correlated with airway bacterial load at baseline ( r = @ ; P = @ ) .


Levofloxacin reduced bacterial load compared with placebo by @-fold ( @ % confidence interval , @-@ @ ; P = @ ) at day @ but had no effect at any point on any marker of neutrophilic airway inflammation .


In patients with a baseline bacterial load of more than @ ( @ ) cfu/mL , levofloxacin treatment was associated with a @ % ( @ % confidence interval , @ % -@ % ; P = @ ) greater reduction in the percentage neutrophil count compared with placebo at day @ .


Change in percentage neutrophil count correlated significantly with baseline airway bacterial load and change in airway bacterial load .


In stable COPD , levofloxacin treatment causes a short-term reduction in bacterial load .


This is associated with a reduction in neutrophilic airway inflammation in patients with high bacterial loads .


Further studies are required to investigate whether this effect is clinically advantageous .


To broaden the ethnic groups in which tapentadol IR is evaluated for treating acute postoperative pain to include Asians .


In this phase @ , multicenter , double-blind , randomized study , @ Korean adults with moderate-to-severe pain following hallux valgus surgery received tapentadol IR @ or @ mg or placebo orally every @-@ hours for @ hours .


Patients requesting other ( rescue ) analgesics during this period were discontinued for lack of efficacy .


The primary endpoint , sum of pain intensity difference ( SPID ) over @ hours , was evaluated based on the difference between tapentadol IR and placebo in least squares ( LS ) mean change from baseline using analysis of covariance ( ANCOVA ) .


Secondary endpoints included the time to first rescue medication use and the distribution of responder rates .


A treatment effect , favoring tapentadol IR , was observed for SPID@ ( p < @ for both doses vs. placebo , ANCOVA ) .


The between-group difference ( vs. placebo ) in LS means of SPID@ was @ ( @ % CI : @ , @ ) for tapentadol IR @ mg and @ ( @ % CI : @ , @ ) for tapentadol IR @ mg .


Time to first rescue medication use was delayed for tapentadol IR ( p < @ for both doses vs. placebo ; log-rank test ) .


The distribution of responders at @ , @ , @ , and @ hours favored tapentadol IR ( p @ for both doses vs. placebo ; Cochran-Mantel-Haenszel test ) .


Dizziness , nausea , and vomiting were each reported in @ % tapentadol-treated patients and at an incidence @-fold higher vs. placebo .


The study findings may be limited by study drug dosing every @ to @ hours and frequent monitoring during treatment , neither of which mimic pain treatment in clinical practice .


However , any potential bias based on this systematic monitoring of patients would be mitigated by the randomized , double-blind nature of the study , with all treatment groups similarly affected by such biases , if any .


Tapentadol IR reduced acute pain intensity , significantly more than placebo , after orthopedic surgery in Korean patients .


Renal fibrosis is common in progressive kidney disease .


Transforming growth factors ( TGF - ) are important mediators of all types of fibrosis , including renal fibrosis .


Chinese rhubarb has been shown to have antifibrotic properties in part because of inhibition of TGF - and has slowed the progression of kidney disease in rodent models .


That administration of a Chinese rhubarb supplement will slow the progression of chronic kidney disease ( CKD ) in cats and the concurrent administration of Chinese rhubarb and benazepril will be more effective than either alone .


Twenty-nine client-owned cats with naturally occurring IRIS Stage @ or early Stage @ CKD and without comorbidity such as cancer , urinary tract obstruction , urinary tract infection , poorly controlled hyperthyroidism , or systemic hypertension were enrolled in the study .


A randomized , positive-controlled , prospective study was performed .


Cats received Chinese rhubarb , benazepril , or both in addition to standard treatment for CKD .


Repeated measures ANOVA was used to assess changes in serum creatinine concentration , body weight , hematocrit , urine protein : urine creatinine ratio ( UPC ) , and systemic arterial blood pressure over time between and within treatment groups over an average of @ months .


No significant differences were detected in serum creatinine concentration , body weight , hematocrit , UPC , and systemic arterial pressure over time between or within treatment groups .


This study failed to detect a significant difference in the progression of CKD in cats treated with Chinese rhubarb , benazepril , or both .


Further study in specific subsets of cats with CKD is warranted .


We hypothesized that the combination of nebivolol and lifestyle modification would reduce large artery stiffness in middle-aged and older hypertensive adults more than either intervention alone .


To address this , @ men and women ( age @-@ years ) with stage I hypertension were randomized to receive either nebivolol ( NB ; forced titration to @ mg OD ; n = @ ; age @ @ years ; body mass index -LSB- BMI -RSB- @ @ kg/m ( @ ) ) , lifestyle modification ( LM ; @-@ % weight loss via calorie restriction and physical activity ; n = @ ; age @ @ years ; BMI @ @ kg/m ( @ ) ) or nebivolol plus lifestyle modification ( NBLM ; n = @ ; age @ @ years ; BMI @ @ kg/m ( @ ) ) for @ weeks .


- stiffness index , a blood-pressure-independent measure of arterial stiffness , and arterial compliance were measured via high-resolution ultrasound and tonometry at baseline and after the @-week intervention .


There was no difference between groups in age , body weight or composition , blood pressure , or in - stiffness index or arterial compliance at baseline ( all p > @ ) .


Following the @-week intervention , body weight decreased ~ @ % ( p < @ ) in the LM and NBLM groups but did not change from baseline in the NB group ( p > @ ) .


Supine brachial and carotid systolic and diastolic blood pressure declined following treatment in each of the groups ( p < @ ) .


However , the magnitude of reduction was not different ( p < @ ) between groups .


- stiffness index declined ( -@ @ , -@ @ and -@ @ U ) and arterial compliance increased similarly ( both p > @ ) in the NB , LM and NBLM groups , respectively .


In summary , our findings indicate that the combination of nebivolol and lifestyle modification reduced large artery stiffness to a similar degree as either intervention alone in middle-aged and older hypertensive adults .


To evaluate the longterm safety of adalimumab administered with or without methotrexate ( MTX ) and compare the efficacy of combination therapy initialization to adalimumab or MTX monotherapy initialization during the open-label extension ( OLE ) of the PREMIER trial ( ClinicalTrials.gov Identifier : NCT@ ) .


Patients with early rheumatoid arthritis ( RA ) were randomized to receive blinded adalimumab + MTX , adalimumab alone , or MTX alone for @ years .


Following the double-blinded period , patients enrolling in the OLE were given adalimumab for up to @ additional years , beginning as monotherapy ; investigators could add MTX at their discretion .


Results for clinical , functional , and radiographic progression were collected for up to @ years of treatment .


During the PREMIER OLE , @/@ patients ( @ % ) completed the trial without new safety signals arising .


Similar proportions of patients discontinued the trial early , although lack of efficacy was reported less often for patients initially randomized to the adalimumab + MTX arm ( @ % ; @ % , and @ % for adalimumab and MTX monotherapies , respectively ) .


Clinical and functional disease control was maintained throughout the trial .


Patients initially randomized to adalimumab + MTX displayed better outcomes , particularly in prevention of radiographic progression ( modified total Sharp score change = @ , @ , @ at Year @ for the initial adalimumab + MTX , adalimumab , and MTX arms , respectively ) .


Intensive therapy with adalimumab + MTX combination in patients with early RA has longterm benefits compared to patients initiating with @-year adalimumab or MTX monotherapy that persists up to @ years following adalimumab OLE .


No new safety findings were observed following longterm adalimumab treatment .


There has been a marked decrease in the eradication rates of Helicobacter pylori infection with standard triple therapy worldwide .


Hence , sequential therapy has gained attention as a promising treatment during the last few years .


This study was carried out to compare the efficacy of sequential versus standard triple therapy in the context of clarithromycin ( CLA ) resistance .


In this study , children between @ and @ years of age , who had documented H. pylori infection , were randomized to receive either standard triple or sequential therapy .


H. pylori eradication was ascertained using the C-urea breath test @-@ weeks after the completion of the treatment .


Real-time PCR was performed on gastric biopsy samples for assessment of CLA resistance .


In all , @ children ( median age : @ years ) were recruited randomly into the study .


The intention-to-treat eradication rates were @ % ( @/@ ) for the sequential treatment group and @ % ( @/@ ) for the standard triple treatment group ( P = @ ) .


A total of @ children completed the study .


The per-protocol eradication rates were @ % ( @/@ ) and @ % ( @/@ ) for sequential and standard triple therapy groups , respectively .


CLA resistance was assessed and @ children were included in the final analysis .


Of @ participants , @ were in the sequential treatment group and @ were in the standard triple treatment group .


The success rates of the respective therapies ( @/@ = @ % in sequential , @/@ = @ % in standard therapy ) were similar ( P = @ ) .


CLA resistance was detected in @ ( @ % ) of the patients .


Eradication rates with sequential therapy in CLA susceptible and resistant cases were @ % ( @/@ ) and @ % ( @/@ ) , respectively ( P = @ ) .


The corresponding figures for the standard triple treatment group were @ % ( @/@ ) and @ % ( @/@ ) ( P = @ ) .


Although a higher eradication rate was observed in CLA-resistant cases with sequential therapy , the difference did not reach statistical significance ( P = @ ) .


In this study , standard triple treatment failed to eradicate H. pylori infection in the majority of the children , and sequential therapy offered only a small advantage over standard triple therapy in the eradication of CLA-resistant strains .


Patients with heartburn but without esophageal erosion respond less well to proton pump inhibitors ( PPIs ) .


There is a growing body of evidence implicating the role of psychological comorbidities in producing reflux symptoms .


Pain modulators improve symptoms in patients with other functional gastrointestinal disorders .


We aimed to compare the efficacy of fluoxetine with omeprazole and placebo to achieve symptomatic relief in patients with heartburn and normal endoscopy who failed once daily PPIs .


Endoscopy-negative patients with heartburn who failed once daily PPIs were randomly allocated to receive @weeks treatment of fluoxetine , omeprazole , or placebo .


Random allocation was stratified according to ambulatory pH monitoring study .


Percentage of heartburn-free days and symptom severity was assessed .


Sixty patients with abnormal and @ patients with normal pH test were randomized .


Subjects receiving fluoxetine experienced more improvement in percentage of heartburn-free days ( median @ , IQR @-@ @ ) than those on omeprazole ( median @ , IQR @-@ , p < @ ) or placebo ( median @ , IQR @-@ @ , p < @ ) .


In normal pH subgroup , fluoxetine was superior to both omeprazole and placebo regarding percentage of heartburn-free days ( median improvement , @ , IQR @-@ @ vs @ , IQR , @-@ @ and @ , @-@ @ , respectively , p < @ ) , but no significant difference was observed between medications in abnormal pH subgroup .


Fluoxetine was superior to omeprazole for improving the symptoms of patients with heartburn and normal endoscopy who failed once daily PPIs .


The superiority of fluoxetine was mostly attributed to those with normal esophageal pH rather than those with abnormal pH ( ClinicalTrials.gov , number NCT@ ) .


Chronic hemodynamically relevant pulmonary regurgitation ( PR ) resulting in important right ventricular dilation and ventricular dysfunction is commonly seen after tetralogy of Fallot ( TOF ) repair .


Late adverse clinical outcomes , including exercise intolerance , arrhythmias , heart failure and/or death accelerate in the third decade of life and are cause for considerable concern .


Timing of pulmonary valve replacement ( PVR ) to address chronic PR is controversial , particularly in asymptomatic individuals , and effect of PVR on clinical measures has not been determined .


Canadian Outcomes Registry Late After Tetralogy of Fallot Repair ( CORRELATE ) is a prospective , multicentre , Canada-wide cohort study .


Candidates will be included if they are @ years of age , have had surgically repaired TOF resulting in moderate or severe PR , and are able to undergo cardiovascular magnetic resonance imaging .


Enrollment of > @ individuals from @ participating centres ( Toronto , Montreal , Quebec City , Sherbrooke , Halifax , Calgary , Edmonton , and Vancouver ) is anticipated .


Clinical data , health-related quality of life metrics , and adverse outcomes will be entered into a web-based database .


A central core lab will analyze all cardiovascular magnetic resonance studies ( PR severity , right ventricular volumes , and ventricular function ) .


Major adverse outcomes ( sustained ventricular tachycardia and cardiovascular cause of death ) will be centrally adjudicated .


To the best of our knowledge , CORRELATE will be the first prospective pan-Canadian cohort study of congenital heart disease in children and adults .


CORRELATE will uniquely link clinical , imaging , and functional data in those with repaired TOF and important PR , thereby enabling critical evaluation of clinically relevant outcomes in those managed conservatively compared with those referred for PVR .


A randomized controlled trial evaluated the effect of telephone-based peer support on preventing postpartum depression ( PPD ) among high-risk mothers .


The results indicated that support provided by peer volunteers may be an effective preventative strategy .


The purpose of this paper is to outline the process of developing , implementing , maintaining , and evaluating the peer support program that we used in this PPD prevention trial .


The peer support program had been used successfully in a pilot trial and a previous breastfeeding peer support trial .


Based on our experience and lessons learned , we developed a @-phase , @-step approach so that the peer support model could be copied and used by different health providers in various settings .


We will use the PPD prevention trial to demonstrate the suggested steps .


The trial aim to prevent the onset of PPD was established .


Peer volunteers who previously experienced and recovered from self-reported PPD were recruited and attended a four-hour training session .


Volunteers were screened and those identified as appropriate to provide support to postpartum mothers were selected .


Women who scored more than @ on the Edinburgh Postnatal Depression Scale within the first two weeks after childbirth were recruited to participate in the trial and proactive , individualized , telephone-based peer support ( mother-to-mother ) was provided to those randomized to the intervention group .


Peer volunteers maintained the intervention , supported other volunteers , and evaluated the telephone-based support program .


Possible negative effects of the intervention were assessed .


An in-depth assessment of maternal perspectives of the program at @weeks postpartum was performed .


The @-phase , @-step approach delineated in this paper provides clear and concise guidelines for health professionals to follow in creating and implementing community-based , peer-support interventions with the potential to prevent PPD .


Many women experience emotional distress , depression and anxiety after a diagnosis of breast cancer .


Psychological stress and depression have been associated with hypothalamic-pituitary-adrenal ( HPA ) axis dysregulation that may adversely affect immune system functioning and impact upon survival .


This study investigated the effects of a lifestyle intervention on indices of psychological health status , HPA axis regulation and immune function in overweight women recovering from early-stage breast cancer treatment .


A total of @ women treated for breast cancer @ to @ months previously were randomly allocated to a @-month exercise and hypocaloric healthy eating program plus usual care or usual care alone ( control group ) .


Women in the intervention group received three supervised exercise sessions per week and individualized dietary advice , supplemented by weekly nutrition seminars .


Depressive symptoms ( Beck Depression Inventory version II : BDI-II ) , perceived stress ( Perceived Stress Scale : PSS ) , salivary diurnal cortisol rhythms ; inflammatory cytokines ( IL-@ and Tumor necrosis factor - ) , leukocyte phenotype counts , natural killer ( NK ) cell cytotoxicity and lymphocyte proliferation following mitogenic stimulation were assessed at baseline and @-month follow up .


Compared with the control group , the intervention group exhibited a reduction in depressive symptoms ( adjusted mean difference , @ % confidence intervals ( @ % CI ) : -@ , -@ to -@ ; P = @ ) at the @-month follow-up but no significant decrease in PSS scores ( -@ , -@ to @ ; P = @ ) .


The lifestyle intervention also had a significant impact on diurnal salivary cortisol rhythm compared with usual care alone , as evidenced by an increase in morning salivary cortisol at the @-month follow-up ( P < @ ) , indicating a change in HPA axis regulation .


Women in the control group had higher total leukocyte , neutrophil and lymphocyte counts in comparison to the intervention group at the @-month follow-up ( P @ ) , whereas there was no difference in NK cell counts ( P = @ ) , NK cell cytotoxicity ( P = @ ) or lymphocyte proliferation responses ( P = @ ) between the two groups .


Our results show that the lifestyle intervention resulted in a reduction in depressive symptoms and a normalisation of HPA axis regulation .


Such changes could have important implications for long-term survival in women recovering from early-breast cancer treatment .


To evaluate the effectiveness of an intervention based on motivational interviewing to reduce medication errors in chronic patients over @ with polypharmacy .


Cluster randomized trial that included doctors and nurses of @ Primary Care centers and chronic patients with polypharmacy over @ years .


The professionals were assigned to the experimental or the control group using stratified randomization .


Interventions consisted of training of professionals and revision of patient treatments , application of motivational interviewing in the experimental group and also the usual approach in the control group .


The primary endpoint ( medication error ) was analyzed at individual level , and was estimated with the absolute risk reduction ( ARR ) , relative risk reduction ( RRR ) , number of subjects to treat ( NNT ) and by multiple logistic regression analysis .


Thirty-two professionals were randomized ( @ doctors and @ nurses ) , @ of them recruited @ patients consecutively ( @ professionals in the experimental group recruited @ patients and @ professionals recruited @ patients in the control group ) and completed @ months of follow-up .


The mean age of patients was @ years ( @ % women ) .


A decrease in the average of medication errors was observed along the period .


The reduction was greater in the experimental than in the control group ( F = @ , P = @ ) .


RRA @ % ( @ % confidence interval -LSB- @ % CI -RSB- @-@ @ % ) , RRR @ ( @ % CI :@ -@ ) , and NNT @ ( @ % CI @-@ @ ) .


Motivational interviewing is more efficient than the usual approach to reduce medication errors in patients over @ with polypharmacy .


Repeated nicotine exposure causes neuroadaptations in limbic cortico-striatal circuits involved in learning and motivation .


Such alterations are relevant to addiction because they are suggested to mediate the ability of smoking-associated stimuli to control behavior and to enhance nicotine-seeking and - taking behaviors .


Female smokers report higher cue reactivity relative to their male counter parts , yet little is known about putative gender-specific effects of adolescent nicotine exposure on reward-related learning .


Prior repeated nicotine exposure in adult male rats enhances Pavlovian approach behavior and conditioned reinforcement .


Given that smoking is typically initiated during adolescence , here we assessed the extent to which adolescent nicotine exposure impacts Pavlovian approach and conditioned reinforcement in male and female rats .


Rats were injected with nicotine on postnatal days @-@ prior to training on Pavlovian approach behavior starting on day @ .


They were trained to associate a conditioned stimulus ( CS ) , illumination of a magazine light , and tone , with an unconditioned stimulus ( US ) , the delivery of water , for @-daily sessions , and then were tested on the acquisition of responding with conditioned reinforcement .


Adolescent nicotine exposure selectively increased approach to the magazine during the CS in males but decreased approach to the magazine during the CS in female rats .


Vehicle-exposed female rats , however , showed greater magazine approach during the CS than did male control rats .


Prior nicotine exposure also enhanced conditioned reinforcement in both male and female rats .


Repeated exposure to nicotine during adolescence had opposite effects on Pavlovian approach behavior in male and female rats but enhanced acquisition of a new response with conditioned reinforcement .


Novel information on how nicotine exposure influences reward-related learning during adolescence may increase our understanding of neurobiological mechanisms involved in the initiation of smoking behavior .


Target vessel revascularization ( TVR ) may compromise the benefits of primary percutaneous coronary intervention in ST-segment elevation myocardial infarction ( STEMI ) We set out to identify the predictors and examine the impact of TVR after STEMI in patients receiving a coronary stent .


In HORIZONS-AMI , @,@ patients with STEMI were randomized to bivalirudin versus heparin and a glycoprotein IIb/IIIa inhibitor .


Stents were implanted in @,@ patients ( @,@ were randomized to bare-metal stents versus paclitaxel-eluting stents , and @ received nonrandomized stents ) .


Target vessel revascularization occurred in @ patients ( @ % ) at @ year and in @ patients ( @ % ) at @ years .


Target vessel revascularization was ischemia-driven in @ cases ( @ % ) .


Target vessel revascularization was due to restenosis in @ patients ( @ % ) , definite stent thrombosis in @ ( @ % ) , and disease progression in @ ( @ % ) .


Independent predictors of TVR were more extensive coronary artery disease , smaller vessel size , longer lesion length and the number of stents implanted , post-percutaneous coronary intervention diameter stenosis , symptom onset to balloon time , treatment with bare-metal stents rather than paclitaxel-eluting stents , and scheduled angiographic follow-up .


Target vessel revascularization was an independent predictor of subsequent myocardial infarction ( hazard ratio -LSB- HR -RSB- @ , P < @ ) , ST ( HR @ , P < @ ) , and major bleeding ( HR @ , P < @ ) but not mortality ( HR @ , P = @ ) .


In HORIZONS-AMI , TVR within @ years after stent implantation was performed in ~ @ of every @ patients and was associated with more extensive coronary disease , more complex procedures , and bare metal stents .


Target vessel revascularization was often due to stent thrombosis and disease progression as well as restenosis and was strongly associated with adverse outcomes but not mortality .


To determine the effect of ranolazine , an anti-ischaemic agent with anti-arrhythmic properties , on the overall burden of atrial fibrillation ( AF ) in acute coronary syndromes ( ACS ) and determine whether ranolazine reduces the long-term incidence of clinical AF after ACS .


MERLIN-TIMI @ randomized patients with non-ST elevation ACS to ranolazine or placebo .


Atrial fibrillation episodes detected on continuous electrocardiogram ( cECG ) monitoring were reviewed in @ patients ( @ % of trial ) .


Atrial fibrillation burden was categorized according to the time in AF : clinically insignificant AF ( < @ % of time ) , paroxysmal AF ( > @-@ % ) , or predominantly persistent AF ( > @ % ) .


Clinical AF events were identified through adverse event reporting for a median @-year follow-up .


Overall , patients assigned to ranolazine had a trend towards fewer episodes of AF -LSB- @ ( @ % ) vs. @ ( @ % ) patients , P = @ -RSB- detected on cECG during the first @ days after randomization .


The pattern of new-onset AF differed between ranolazine vs. placebo : clinically insignificant AF ( five patients in ranolazine vs. seven in placebo ) , paroxysmal AF ( @ vs. @ patients ) , and predominantly chronic AF ( @ vs. @ patients , three-way P < @ ) .


Among patients with a paroxysmal AF pattern , the overall burden was lower with ranolazine than with placebo ( median @ vs. @ % , P = @ ) .


Over the median @-year follow-up , fewer patients treated with ranolazine experienced an AF event compared with placebo ( @ vs. @ % , RR @ , P = @ ) .


Ranolazine , an anti-anginal agent with electrophysiological effects , may reduce the frequency of paroxysmal AF in patients with non-ST elevation ACS with a pattern of lower overall AF burden in this group .


Ranolazine reduced the overall @-year incidence of clinical AF events .


These atrial-specific anti-arrhythmic properties of ranolazine may be of clinical interest and warrant additional investigation .


The incidence of cardiovascular disease ( CVD ) in rheumatoid arthritis ( RA ) is increased compared to the general population .


Immune dysregulation and systemic inflammation are thought to be associated with this increased risk .


Early diagnosis with immediate treatment and tight control of RA forms a central treatment paradigm .


It remains unclear , however , whether using tumor necrosis factor inhibitors ( TNFi ) to achieve remission confer additional beneficial effects over standard therapy , especially on the development of CVD .


Coronary Artery Disease Evaluation in Rheumatoid Arthritis ( CADERA ) is a prospective cardiovascular imaging study that bolts onto an existing single-centre , randomized controlled trial , VEDERA ( Very Early versus Delayed Etanercept in Rheumatoid Arthritis ) .


VEDERA will recruit @ patients with early , treatment-nave RA , randomized to TNFi therapy etanercept ( ETN ) combined with methotrexate ( MTX ) , or therapy with MTX with or without additional synthetic disease modifying anti-rheumatic drugs with escalation to ETN following a ` treat-to-target ' regimen .


VEDERA patients will be recruited into CADERA and undergo cardiac magnetic resonance ( CMR ) assessment with ; cine imaging , rest/stress adenosine perfusion , tissue-tagging , aortic distensibility , T@ mapping and late gadolinium imaging .


Primary objectives are to detect the prevalence and change of cardiovascular abnormalities by CMR between TNFi and standard therapy over a @-month period .


All patients will enter an inflammatory arthritis registry for long-term follow-up .


CADERA is a multi-parametric study describing cardiovascular abnormalities in early , treatment-nave RA patients , with assessment of changes at one year between early biological therapy and conventional therapy .


To evaluate the effectiveness of efforts to translate and disseminate evidence-based guidelines about atypical antipsychotic use to nursing homes ( NHs ) .


Three-arm , cluster randomized trial .


NHs .


NHs in the state of Connecticut .


Evidence-based guidelines for atypical antipsychotic prescribing were translated into a toolkit targeting NH stakeholders , and @ NHs were recruited and randomized to one of three toolkit dissemination strategies : mailed toolkit delivery ( minimal intensity ) ; mailed toolkit delivery with quarterly audit and feedback reports about facility-level antipsychotic prescribing ( moderate intensity ) ; and in-person toolkit delivery with academic detailing , on-site behavioral management training , and quarterly audit and feedback reports ( high intensity ) .


Outcomes were evaluated using the Reach , Effectiveness , Adoption , Implementation , Maintenance ( RE-AIM ) framework .


Toolkit awareness of @ % ( @/@ ) of leadership of low-intensity NHs , @ % ( @/@ ) of moderate-intensity NHs , and @ % ( @/@ ) of high-intensity NHs reflected adoption and implementation of the intervention .


Highest levels of use and knowledge among direct care staff were reported in high-intensity NHs .


Antipsychotic prescribing levels declined during the study period , but there were no statistically significant differences between study arms or from secular trends .


RE-AIM indicators suggest some success in disseminating the toolkit and differences in reach , adoption , and implementation according to dissemination strategy but no measurable effect on antipsychotic prescribing trends .


Further dissemination to external stakeholders such as psychiatry consultants and hospitals may be needed to influence antipsychotic prescribing for NH residents .


An intervention trial of the ` SuperAmma ' village-level intervention to promote handwashing with soap ( HWWS ) in rural India demonstrated substantial increases in HWWS amongst the target population .


We carried out a process evaluation to assess the implementation of the intervention and the evidence that it had changed the perceived benefits and social norms associated with HWWS .


The evaluation also aimed to inform the design of a streamlined shorter intervention and estimate scale up costs .


Intervention implementation was observed in @ villages .


Semi-structured interviews were conducted with the implementation team , village leaders and representatives of the target population .


A questionnaire survey was administered in @ households in intervention villages and @ households in control villages to assess exposure to intervention activities , recall of intervention components and evidence that the intervention had produced changes in perceptions that were consistent with the intervention core messages .


Costs were estimated for the intervention as delivered , as well as for a hypothetical scale-up to @,@ villages .


We found that the intervention was largely acceptable to the target population , maintained high fidelity ( after some starting problems ) , and resulted in a high level of exposure to most components .


There was a high recall of most intervention activities .


Subjects in the intervention villages were more likely than those in control villages to cite reasons for HWWS that were in line with intervention messaging and to believe that HWWS was a social norm .


There were no major differences between socio-economic and caste groups in exposure to intervention activities .


Reducing the intervention from @ to @ contact days , in a scale up scenario , cut the estimated implementation cost from $ @,@ to $ @,@ per village .


The SuperAmma intervention is capable of achieving good reach across men and women of varied social and economic status , is affordable , and has the potential to be effective at scale , provided that sufficient attention is given to ensuring the quality of intervention delivery .


Recent trials demonstrate the acceptability and short term efficacy of primary care referral to a commercial weight loss provider for weight management .


Commissioners now need information on the optimal duration of intervention and the longer term outcomes and cost effectiveness of such treatment to give best value for money .


This multicentre , randomised controlled trial with a parallel design will recruit @ overweight adults ( BMI @kg/m@ ) through their primary care provider .


They will be randomised in a @:@:@ allocation to : Brief Intervention , Commercial Programme for @weeks , or Commercial Programme for @weeks .


Participants will be followed up for two years , with assessments at @ , @ , @ and @months .


The sequential primary research questions are whether the CP interventions achieve significantly greater weight loss from baseline to @months than BI , and whether CP@ achieves significantly greater weight loss from baseline to @months than CP@ .


The primary outcomes will be an intention to treat analysis of between treatment differences in body weight at @months .


Clinical effectiveness will be also be assessed by measures of weight , fat mass , and blood pressure at each time point and biochemical risk factors at @months .


Self-report questionnaires will collect data on psychosocial factors associated with adherence , weight-loss and weight-loss maintenance .


A within-trial and long-term cost-effectiveness analysis will be conducted from an NHS perspective .


Qualitative methods will be used to examine the participant experience .


The current trial compares the clinical and cost effectiveness of referral to a commercial provider with a brief intervention .


This trial will specifically examine whether providing longer weight-loss treatment without altering content or intensity ( @months commercial referral vs. @weeks ) leads to greater weight loss at one year and is sustained at @years .


It will also evaluate the relative cost-effectiveness of the three interventions .


This study has direct implications for primary care practice in the UK and will provide important information to inform the decisions of practitioners and commissioners about service provision .


Recent studies suggest that self-explanation ( SE ) while diagnosing cases fosters the development of clinical reasoning in medical students ; however , the conditions that optimise the impact of SE remain unknown .


The example-based learning framework justifies an exploration of students ' use of their own SEs combined with the study of examples .


This study aimed to assess the impact on medical students ' diagnostic performance of : ( i ) combining students ' SEs with their listening to examples of residents ' SEs , and ( ii ) the addition of prompts ( specific questions ) while working with examples .


This study consisted of a training phase and an assessment phase conducted @ week later .


In the training phase , @ Year @ medical students were randomly assigned to one of three groups .


In all groups , students first solved four clinical cases using SE .


Subsequently , Group @ listened to examples of residents ' SEs with prompts ; Group @ listened to examples of residents ' SEs without prompts , and the control group solved word puzzles .


Then , all students again solved the same four cases .


One week later , all students solved four similar and four different cases .


Students ' diagnostic performance and diagnostic accuracy scores were assessed for each case at each time-point .


Although all groups ' diagnostic accuracy scores on similar cases improved significantly between the training and the assessment phase , Group @ showed a significantly higher diagnostic performance score after @ week than the control group ( p = @ ) .


On different cases , Group @ obtained significantly higher diagnostic accuracy ( p = @ ) and diagnostic performance ( p < @ ) scores than the control group and a significantly higher diagnostic performance score than Group @ ( p = @ ) .


Self-explanation seems to be an effective technique to help medical students learn clinical reasoning .


Its impact is increased significantly by combining it with examples of residents ' SEs and prompts .


Although students ' exposure to examples of clinical reasoning is important , their ` active processing ' of these examples appears to be critical to their learning from them .


To evaluate the effect of modulating pouch emptying ( PE ) and SI transit of glucose after Roux-en-Y gastric bypass ( RYGB ) on blood glucose , incretin hormones , glucose absorption and gastrointestinal ( GI ) symptoms .


Ten RYGB patients were studied twice in random order , receiving either a @ ml glucose drink ( @ kcal ) or the same solution infused into the proximal Roux-limb at @ kcal/min .


Data were compared with @ healthy volunteers who received a @ kcal/min duodenal infusion .


PE , cecal arrival time ( CAT ) , blood glucose , plasma @-O-methylglucose ( @-OMG ) , insulin , glucose-dependent insulinotropic polypeptide ( GIP ) , and glucagon-like peptide-@ ( GLP-@ ) , and GI symptoms were measured .


In RYGB subjects , the glucose drink emptied very rapidly ( PE t@ = @ min ) and intestinal glucose infusion was associated with higher blood glucose and plasma @-OMG , but lower plasma GLP-@ , GIP , insulin , and GI symptoms than oral glucose ( all P < @ ) , and comparable to volunteers .


In RYGB subjects , CAT correlated inversely with peak GLP-@ ( r = -@ , P = @ ) , and plasma @-OMG correlated tightly blood glucose ( r = @ , P < @ ) .


After RYGB , reducing intestinal glucose delivery to @ kcal/min is associated with higher blood glucose , greater glucose absorption , lower incretin responses , and less GI symptoms , supporting rapid transit contribution to the exaggerated incretin responses and `` dumping symptoms '' .


Vitamin A supplementation in children aged @ months to @ years has been shown to reduce mortality .


The efficacy of neonatal supplementation with vitamin A to reduce mortality in the first @ months of life is plausible but not established .


We aimed to assess the efficacy of neonatal oral supplementation with vitamin A to reduce mortality between supplementation and @ months of age .


We undertook an individually randomised , double-blind , placebo-controlled trial in Haryana , India .


We identified pregnant women through a surveillance programme undertaken every @ months of all female residents in two districts of Haryana , India , aged @-@ years , and screened every identified livebirth .


Eligible participants were neonates whose parents consented to participate , were likely to stay in the study area until at least @ months of age , and were able to feed orally at the time of enrolment .


Participants were randomly assigned to receive oral capsules containing vitamin A ( retinol palmitate @,@ IU plus vitamin E @-@ IU ) or placebo ( vitamin E @-@ IU ) within @ h of birth .


Randomisation was in blocks of @ according to a randomisation list prepared by a statistician not otherwise involved with the trial .


Investigators , participants ' families , and the data analysis team were masked to treatment allocation .


The primary outcome was mortality between supplementation and @ months of age .


Analysis included all participants assigned to study groups .


This trial is registered with ClinicalTrials.gov , number NCT@ , and the Indian Council of Medical Research Clinical Trial Registry , number CTRI/@/@ / @ .


Between June @ , @ , and July @ , @ we screened @,@ neonates and randomly assigned @,@ to receive vitamin A ( @,@ ) or placebo ( @,@ ) .


Between supplementation and @ months of age , @ infants died in the vitamin A group compared with @ in the placebo group ( @ per @ vs @ per @ ; difference -@ per @ , @ % CI -@ to @ ; risk ratio @ , @ % CI @ to @ ) .


We noted no significant interactions between the intervention effect and sex on mortality at @ months ( p = @ ) .


Supplementation with @,@ IU vitamin A within the first @ h of life was generally safe and well tolerated , with the exception of a small excess risk of transient bulging fontanelle ( @ cases in the vitamin A group confirmed by physician vs @ cases in the placebo group , risk ratio @ -LSB- @ % CI @-@ -RSB- ) .


The findings of this study , done in a population in which vitamin A deficiency is a moderate public health problem , are consistent with a modest reduction in mortality between supplementation and @ months of age .


These findings must be viewed together with similar trials in other populations to enable determination of appropriate public health policy .


To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures .


This British multi-site study recruited seventeen symptomatic adult patients with refractory strictures .


Patients were randomised using a multicentre , blinded assessor design , comparing a biodegradable stent ( BS ) with endoscopic dilatation ( ED ) .


The primary endpoint was the average dysphagia score during the first @ mo. .


Secondary endpoints included repeat endoscopic procedures , quality of life , and adverse events .


Secondary analysis included follow-up to @ mo. .


Sensitivity analyses explored alternative estimation methods for dysphagia and multiple imputation of missing values .


Nonparametric tests were used .


Although both groups improved , the average dysphagia scores for patients receiving stents were higher after @ mo : BS-ED @ ( @ % CI : @-@ @ ) P = @ .


The finding was robust under different estimation methods .


Use of additional endoscopic procedures and quality of life ( QALY ) estimates were similar for BS and ED patients at @ and @ mo. .


Concomitant use of gastrointestinal prescribed medication was greater in the stent group ( BS @ , ED @ prescriptions ; P < @ ) , as were related adverse events ( BS @ , ED @ events ; P = @ ) .


Groups were comparable at baseline and findings were statistically significant but numbers were small due to under-recruitment .