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


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


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


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


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


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


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


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


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


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


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


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


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


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


The incidence of the primary end point did not differ significantly between the adaptive servo-ventilation group and the control group ( @ % and @ % , respectively ; hazard ratio , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ; P = @ ) .


All-cause mortality and cardiovascular mortality were significantly higher in the adaptive servo-ventilation group than in the control group ( hazard ratio for death from any cause , @ ; @ % CI , @ to @ ; P = @ ; and hazard ratio for cardiovascular death , @ ; @ % CI , @ to @ ; P = @ ) .


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


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


During the LCD period , subjects lost @ ( @ , @ ) kg ( mean ( @ % confidence interval ( CI ) ) ) .


Average weight regain over the @-month intervention period was @ ( @ % CI @-@ @ ) kg .


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


The difference in weight regain after @ year was @ ( @ , @ ) kg ( P = @ ) ( completers analysis , N = @ ) or @ ( @ , @ ) kg ( P < @ ) ( intention-to-treat analysis , N = @ ) .


No consistent effect of GI on weight regain was found .


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


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


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


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


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


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


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


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


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


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


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


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


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


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


The symptoms measured by the visual scale were significantly reduced .


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


The effects persisted for up to @ weeks .


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


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


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


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


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


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


Each group underwent training @ days weekly for @ weeks .


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


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


Both groups attended educational classes .


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


Changes in albumin levels were not statistically significant relative to the interaction effect between time and group ( F ( @ , @ ) = @ , p = @ ) nor the main effects of time ( F ( @ , @ ) = @ , p = @ ) and group ( F ( @ , @ ) = @ , p = @ ) .


A mixed between-within subjects ANOVA revealed significant interaction effects between time and group for the peak work rate of the unsupported upper limb exercise ( F ( @ , @ ) = @ , p = @ ) , endurance time ( F ( @ , @ ) = @ , p = @ ) , levels of anxiety ( F ( @ , @ ) = @ , p = @ ) and depression ( F ( @ , @ ) = @ , p = @ ) , and the SF-@ physical component summary ( F ( @ , @ ) = @ , p = @ ) .


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


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


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


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


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


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


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


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


This study is registered with ClinicalTrials.gov , number NCT@ .


@ patients were assigned to alogliptin ( n = @ ) or placebo ( n = @ ) and followed up for a median of @ days ( IQR @-@ ) .


The exploratory extended MACE endpoint was seen in @ ( @ % ) patients assigned to alogliptin and in @ ( @ % ) assigned to placebo ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ ) .


Hospital admission for heart failure was the first event in @ ( @ % ) patients taking alogliptin compared with @ ( @ % ) taking placebo ( HR @ , @ % CI @-@ ) .


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


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


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


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


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


Tiotropium was included as an open-label treatment arm .


The primary efficacy endpoint was trough forced expiratory volume in @ second ( FEV@ ) on Day @ .


Secondary efficacy endpoints included weighted mean FEV@ over @-@ hours after morning dosing on Day @ , and serial FEV@ at each time point over @ hours after morning dosing on Day @ .


Safety and pharmacokinetics were also examined .


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


Based on the population dose-response model of trough FEV@ data , the geometric mean potency ( ED@ ) of UMEC was @ g ( @ % confidence interval -LSB- CI -RSB- : @ , @ ) with a predicted maximum intrinsic efficacy ( Emax ) at trough of @ L ( @ % CI : @ , @ ) after QD dosing .


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


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


Increases in FEV@ over @-@ hours were similar to those observed over @-@ hours after the second dose of UMEC was administered .


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


Adverse events , generally mild , were highest with UMEC @ g QD ( @ % ) compared with placebo ( @ % ) , tiotropium ( @ % ) and other UMEC doses ( @-@ % ) .


UMEC is a potent QD bronchodilator with geometric mean ED@ of @ g.


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


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


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


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


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


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


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


Patients are included regardless of their previous adherence .


The intervention has a duration of twelve months .


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


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


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


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


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


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


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


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


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


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


Lady Reading Hospital Peshawar .


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


Group-A had @ ( @ % ) male and @ ( @ % ) females while group-B had @ ( @ % ) males and @ ( @ % ) females ( p = @ ) .


Mean age was @ + / - @ years in group-A and was @ + / - @ years in group-B ( p = @ ) .


Mean body weight was @ ?


@ Kg in group-A and @ + / - @ Kg in group-B ( p = @ ) .


Mean Baseline platelet aggregation before drug administration was @ + / - @ ohm in group-A while @ + / - @ ohm in group-B ( p = @ ) .


Mean Follow up platelet aggregation @ hours after drug administration was @ + / - @ in group-A while it was @ + / - @ ohm in group-B ( p = @ ) .


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


@ ( @ % ) of group-A had inhibition of platelets aggregation > @ % as compare to @ ( @ % ) of group-B had inhibition of platelets aggregation > @ % ( p = @ ) .


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


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


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


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


From June @ to June @ , @ consecutive patients with thoracolumbar burst fractures were enrolled .


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


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


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


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


All patients were followed up from @ to @ months .


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


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


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


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


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


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


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


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


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


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


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


The data were analyzed using defined knowledge and performance parameters .


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


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


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


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


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


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


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


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


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


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


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


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


The most symptomatic hand was imaged with @ Tesla extremity MRI at weeks @ , @ , @ and @ .


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


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


TCZ + PBO ( n = @ ) demonstrated mean improvements in synovitis from baseline to weeks @ ( -@ ; p = @ ) , @ ( -@ ; p < @ ) and @ ( -@ ; p < @ ) , while TCZ + MTX ( n = @ ) had mean improvements in synovitis at week @ ( -@ ; p = @ ) , but not week @ ( -@ ; p = @ ) .


TCZ+PBO demonstrated mean reductions in osteitis at weeks @ ( -@ ; p = @ ) and @ ( -@ ; p = @ ) , while TCZ+MTX had mean reductions at weeks @ ( -@ ; p < @ ) and @ ( -@ ; p = @ ) , but not week @ ( -@ ; p = @ ) .


Mean erosion scores did not worsen in either group .


MRI erosion scores at weeks @ and @ correlated strongly with radiography erosion scores at week @ ( r > @ ) .


Baseline synovitis and worsening of osteitis predicted erosion progression .


Rapid suppression of synovitis and osteitis with reduction in structural joint damage progression occurred with TCZ , as monotherapy or in combination with MTX , through week @ .


Recent posttrial analysis of a completed randomized trial found an increased risk of prostate cancer among healthy men taking high-dose vitamin E supplements .


Trials that examined the effect of vitamin C supplements on cancer risk are few .


We examined whether vitamin E or vitamin C supplementation affects the risk of cancer events during posttrial follow-up of the Physicians ' Health Study II .


Beginning in @ , a total of @,@ US male physicians aged @ y were randomly assigned to receive @ IU of vitamin E every other day , @ mg of vitamin C daily , or their respective placebos .


The vitamin E and vitamin C treatment ended in @ , and observational follow-up continued through June @ .


This study included an additional @ cases of incident prostate cancer and @ total cancers that developed during a mean ( maximum ) of @ ( @ ) y of posttrial observation .


During an overall mean of @ ( @ ) y , there were a total of @ incident prostate cancers and @ total cancers documented .


In comparison with placebo , vitamin E supplementation had no effect on the incidence of prostate cancer ( HR : @ ; @ % CI : @ , @ ) or total cancers ( HR : @ ; @ % CI : @ , @ ) .


There was also no effect of vitamin C supplementation on total cancers ( HR : @ ; @ % CI : @ , @ ) or incident prostate cancer ( HR : @ ; @ % CI : @ , @ ) .


Neither vitamin E nor vitamin C supplementation had effects on other site-specific cancers overall .


Stratification by known cancer risk factors , history of cancer , other randomized treatment , and follow-up time showed no significant interactions .


In this large-scale randomized trial in men , vitamin E and C supplementation had no immediate or long-term effects on the risk of total cancers , prostate cancer , or other site-specific cancers .


Although millions of aesthetic procedures are performed annually , few patient-reported outcome ( PRO ) measures have been used in this setting .


To evaluate the impact of onabotulinumtoxinA treatment for crow 's feet lines ( CFL ) on relevant psychological variables and self-perception of age/appearance in subgroup populations .


Facial Lines Outcomes ( FLO-@ ) Questionnaire , Self-Perception of Age ( SPA ) , and Subject Global Assessment of Change in CFL ( SGA-CFL ) were PRO measures administered in @ Phase @ , double-blind placebo-controlled trials for the treatment of CFL alone or CFL/glabellar lines ( GL ) .


Patient-reported outcome measures were analyzed by subgroups ( age , gender , and baseline CFL severity ) .


Subject satisfaction with appearance was also analyzed .


Most subgroups receiving onabotulinumtoxinA demonstrated significant improvements in psychological impact ( FLO-@ Items @ , @ , and @ ) versus placebo at Day @ ( p @ ) .


OnabotulinumtoxinA-treated subjects consistently rated themselves as looking younger on SPA versus placebo in all subgroups at Day @ ( p @ ) and showed significant improvements in CFL appearance versus placebo at all time points on SGA-CFL .


Overall , subjects were satisfied with their appearance .


OnabotulinumtoxinA-treated subjects experienced significant improvements in perceived appearance , attractiveness , tiredness , age , and satisfaction versus placebo .


Subjects treated for CFL and GL experienced even greater effects .


Retrospective single institution data suggest that postoperative pain after robot-assisted laparoscopic radical prostatectomy is decreased by early removal of the urethral catheter with suprapubic tube drainage .


In a randomized patient population we determined whether suprapubic tube drainage with early urethral catheter removal would improve postoperative pain compared with urethral catheter drainage alone .


Men with a body mass index of less than @ kg/m ( @ ) who had newly diagnosed prostate cancer and elected robot-assisted laparoscopic radical prostatectomy were included in analysis .


Block randomization by surgeon was used and randomization assignment was done after completing the urethrovesical anastomosis .


In patients assigned to suprapubic tube drainage the urethral catheter was removed on postoperative day @ and all catheters were removed on postoperative day @ .


Visual analog pain scale and satisfaction questionnaires were administered on postoperative days @ , @ and @ .


A total of @ patients were randomized to the urethral catheter vs @ to the suprapubic tube plus early urethral catheter removal at the time of interim futility analysis .


Mean visual analog pain scale scores did not differ between the groups at any time point and a similar percent of patients cited the catheter as the greatest bother with nonsignificant differences in treatment related satisfaction .


Complications during postoperative week @ did not vary between the groups .


Based on interim results the trial was terminated due to lack of effect .


Patients randomized to suprapubic tube vs urethral catheter drainage for the week after prostatectomy had similar pain , catheter related bother and treatment related satisfaction in the perioperative period .


We no longer routinely offer suprapubic tube drainage with early urethral catheter removal at our institution .


To investigate the clinical effect of combination therapy with high-frequency oscillation ventilation ( HFOV ) , pulmonary surfactant ( PS ) and inhaled nitric oxide ( iNO ) in the treatment of neonatal hypoxemic respiratory failure ( HRF ) .


A total of @ neonates with HRF were studied , and they were randomly divided into two groups : triple therapy ( n = @ ) and dual therapy ( n = @ ) .


The triple therapy group received HFOV , PS , and iNO , while the dual therapy group received HFOV and iNO .


Blood gas values , PaO@/FiO@ ( P/F ) , oxygenation index ( OI ) , and pulmonary arterial pressure ( PA ) were determined before treatment and after @ and @ hours of treatment .


Among the neonates with different P/F ratios and OI values and with or without persistent pulmonary hypertension of the newborn ( PPHN ) , the treatment outcomes of two groups were compared .


The durations of mechanical ventilation and iNO therapy in the triple therapy group were significantly shorter than in the dual therapy group ( P < @ ) .


After @ and @ hours of treatment , the triple therapy group had significantly improve PaO@ and PaCO@ compared with the dual therapy group ( P < @ ) .


After @ and @ hours of treatment , the neonates with PPHN in the triple therapy group had significantly decreased PA compared with the dual therapy group ( P < @ ) .


In the cases with a P/F ratio of @ , the triple group had a significantly higher cure rate than the dual therapy group ( P < @ ) .


In both groups , the P/F ratios of the neonates who died were significantly lower than those of survivors ( P < @ ) .


In the cases with an OI of @ , the triple group had a significantly higher cure rate than the dual therapy group ( P < @ ) .


In both groups , the OI values of the neonates who died were significantly higher than those of survivors ( P < @ ) .


In neonates with PPHN , the triple group had a significantly higher cure rate than the dual therapy group ( P < @ ) .


The triple therapy group had a significantly shorter length of hospital stay ( P < @ ) and a significantly higher cure rate ( P < @ ) compared with the dual therapy group .


There were no significant differences in complications between the two groups ( P > @ ) .


No severe side effect was found during the treatment in either group .


Triple therapy with HFOV , PS and iNO is a more effective treatment for neonatal HRF compared with the dual therapy with HFOV and iNO .


The triple therapy can significantly improve oxygenation and survival rate , providing a new treatment for the neonates with HRF , especially the critical cases who suffer severe lung disease with PPHN and have a P/F ratio of @ or an OI of @ .


Several neuroscience tools showed the involvement of auditory cortex in chronic tinnitus .


In this proof-of-principle study we probed the capability of functional near-infrared spectroscopy ( fNIRS ) for the measurement of brain oxygenation in auditory cortex in dependence from chronic tinnitus and from intervention with transcranial magnetic stimulation .


Twenty-three patients received continuous theta burst stimulation over the left primary auditory cortex in a randomized sham-controlled neuronavigated trial ( verum = @ ; placebo = @ ) .


Before and after treatment , sound-evoked brain oxygenation in temporal areas was measured with fNIRS .


Brain oxygenation was measured once in healthy controls ( n = @ ) .


Sound-evoked activity in right temporal areas was increased in the patients in contrast to healthy controls .


Left-sided temporal activity under the stimulated area changed over the course of the trial ; high baseline oxygenation was reduced and vice versa .


By demonstrating that rTMS interacts with auditory evoked brain activity , our results confirm earlier electrophysiological findings and indicate the sensitivity of fNIRS for detecting rTMS induced changes in brain activity .


Moreover , our findings of trait - and state-related oxygenation changes indicate the potential of fNIRS for the investigation of tinnitus pathophysiology and treatment response .


To evaluate the effect of combination of ranibizumab and laser photocoagulation to peripheral retinal areas of nonperfusion in patients with non-ischemic central retinal vein occlusion ( CRVO ) without neovascularizations .


This prospective , proof of concept study randomized @ CRVO patients into two arms .


The RL group ( ranibizumab + laser ; n = @ ) received ranibizumab with additive laser photocoagulation ; the control R group ( n = @ ) was treated with ranibizumab only .


All patients received three initial monthly ranibizumab injections followed by PRN regimen .


Changes in best corrected visual acuity ( BCVA ) and in central retinal thickness ( CRT ) were documented over @ months .


Median of BCVA improved in the RL group from @ ETDRS letters ( interquartile range IQR = @ letters ) at baseline to @ ( IQR = @ ) letters at month @ .


In the control group BCVA remained stable -LSB- baseline : @ ( IQR = @ ) and month @ : @ ( IQR = @ ) letters -RSB- .


CRT decreased between baseline and final visit in the RL group from @ ( IQR = @ ) m to @ ( IQR = @ ) m , and in the control group from @ ( IQR = @ ) m to @ ( IQR = @ ) m.


More pronounced improvements in BCVA were seen in the RL group ( medians = @ vs. @ letters ) although the observed group differences were not statistically significant due to small samples .


The selective laser photocoagulation of peripheral areas of nonperfusion seems to lead to additional visual improvement in patients with CRVO .


A larger replication trial is necessary to confirm the results of this proof of concept study .


To evaluate the effectiveness of a coparenting intervention on exclusive breastfeeding among primiparous mothers and fathers .


A randomized controlled trial was conducted in a large teaching hospital in Toronto , Canada .


Couples were randomized to receive either usual care ( n = @ ) or a coparenting breastfeeding support intervention ( n = @ ) .


Follow-up of exclusive breastfeeding and diverse secondary outcomes was conducted at @ and @ weeks postpartum .


Significantly more mothers in the intervention group than in the control group continued to breastfeed at @ weeks postpartum ( @ % vs @ % , P = @ ) .


Although proportionately more mothers in the intervention group were exclusively breastfeeding at @ and @ weeks , these differences were not significant .


Fathers in the intervention group had a significantly greater increase in breastfeeding self-efficacy scores from baseline to @ weeks postpartum compared with fathers in the control group ( P = @ ) .


In addition , significantly more mothers in the intervention group than in the control group reported that their partners provided them with breastfeeding help in the first @ weeks ( @ % vs @ % , P = @ ) and that they were satisfied with their partners ' involvement with breastfeeding ( @ % vs @ % , P = @ ) .


Mothers in the intervention group were also more satisfied with the breastfeeding information they received ( @ % vs @ % , P < @ ) .


The significant improvements in breastfeeding duration , paternal breastfeeding self-efficacy , and maternal perceptions of paternal involvement and assistance with breastfeeding suggest that a coparenting intervention involving fathers warrants additional investigation .


To examine the effect of rilonacept on the health-related quality of life ( HRQoL ) in patients with poorly controlled familial Mediterranean fever ( FMF ) .


As part of a randomized , double-blinded trial comparing rilonacept and placebo for the treatment of FMF , patients/parents completed the modified Child Health Questionnaire ( CHQ ) at baseline , and at the start and end of each of @ treatment courses , @ each with rilonacept and placebo .


Fourteen subjects were randomized ; mean age was @ @ years .


At baseline the physical HRQoL score was significantly less ( @ @ ) but the psychosocial score was similar to the population norm ( @ @ ) .


There were significant improvements in most HRQoL concepts after rilonacept but not placebo .


Significant differences between rilonacept and placebo were found in the physical ( @ @ versus @ @ , P = @ ) but not psychosocial scores ( @ @ versus @ @ , P = @ ) .


The physical HRQoL was significantly impacted by the treatment effect and patient global assessment .


Treatment with rilonacept had a beneficial effect on the physical HRQoL in patients with poorly controlled FMF and was also significantly related to the patient global assessment .


This trial is registered with ClinicalTrials.gov Identifier NCT@ .


An elevated resting heart rate ( RHR ) may be an early sign of cardiac failure , but its prognostic value during watchful waiting in asymptomatic aortic stenosis ( AS ) is largely unknown .


RHR was determined by annual ECGs in the Simvastatin and Ezetimibe in Aortic Stenosis ( SEAS ) study of asymptomatic mild-to-moderate AS patients .


Primary endpoint in this substudy was major cardiovascular events ( MCEs ) and secondary outcomes its individual components .


Multivariable Cox-models using serially-measured RHR were used to examine the prognostic impact of RHR per se .


@ patients were followed for a mean of @ years ( @ patient-years of follow-up ) , @ ( @ % ) MCEs occurred , @ % ( n = @ ) died , including @ cardiovascular deaths .


In multivariable analysis , baseline RHR was independently associated with MCEs ( HR @ per @min ( -@ ) faster , @ % CI : @-@ @ ) and cardiovascular mortality ( HR @ per @min ( -@ ) faster , @ % CI : @-@ @ , both p@ @ ) .


Updating RHR with annual in-study reexaminations , time-varying RHR was highly associated with excess MCEs ( HR @ per @min ( -@ ) faster , @ % CI : @-@ @ ) and cardiovascular mortality ( HR @ per @min ( -@ ) faster , @ % CI : @-@ @ , both p@ @ ) .


The association of RHR with MCEs and cardiovascular mortality was not dependent on atrial fibrillation status ( both p@ @ for interaction ) .


RHR is independently associated with MCEs and cardiovascular death in asymptomatic AS ( Clinicaltrials.gov ; unique identifier NCT@ ) .


The aim of the present study was to evaluate the efficacy and safety of narrowband UVB ( NB-UVB ) compared with tacrolimus ointment @ % in patients with bilateral vitiligo .


In this comparative study , four groups of patients were randomized .


Each group was composed by @ patients with bilateral vitiligo ; in each group , every patient was irradiated with NB-UVB ( length : @ nm ) twice a week for @ months and applied tacrolimus ointment @ % twice a day on the other area in the same period .


Before starting therapy and after @ , @ and @ months of therapy , a clinical and photographic evaluation of percentage of repigmentation was performed and Dermatology Life Quality Index Questionnaire was fulfilled .


A repigmentation at least partial occurred in @ % of patients after @ weeks of treatment with tacrolimus ointment @ % ; in the whole sample , @ patients ( @ % ) showed no repigmentation at all , with @ of them discontinuing the therapy because of side effects ( erythema and folliculitis-like manifestations ) .


A homogeneous repigmentation at least partial occurred in @ % of patients after @ weeks of treatment with NB-UVB ; in the whole sample @ patients ( @ % ) showed no repigmentation at all , with @ of them discontinuing the therapy because of side effects .


The present study confirmed that the efficacy of NB-UVB phototherapy in vitiligo is comparable to tacrolimus ointment @ % therapy .


On the basis of our study , we may suggest tacrolimus ointment @ % as an alternative to NB-UVB therapy for treating vitiligo .


In order to quantify the effects of physical activity such as walking on chronic disease , accurate measurement of physical activity is needed .


The objective of this study was to determine the validity and reliability of a new activity monitor , the Fitbit One , in a population of healthy adults .


Cross-sectional study .


Thirty healthy adults ambulated at @ different speeds ( @ , @ , @ , @ , @ m/s ) on a treadmill while wearing three Fitbit One activity monitors ( two on the hips and one in the pocket ) .


The order of each speed condition was randomized .


Fitbit One step count output was compared to observer counts and distance output was compared to the calibrated treadmill output .


Two-way repeated measures ANOVA , concordance correlation coefficients , and Bland and Altman plots were used to assess validity and intra-class correlation coefficients ( ICC ) were used to assess reliability .


No significant differences were noted between Fitbit One step count outputs and observer counts , and concordance was substantial ( @-@ @ ) .


Inter-device reliability of the step count was high for all walking speeds ( ICC @ ) .


Percent relative error was less than @ % .


The distance output of the Fitbit One activity monitors was significantly different from the criterion values for each monitor at all speeds ( P < @ ) and exhibited poor concordance ( @-@ @ ) .


Inter-device reliability was excellent for all treadmill speeds ( ICC @ ) .


Percent relative error was high ( up to @ % ) .


The Fitbit One activity monitors are valid and reliable devices for measuring step counts in healthy young adults .


The distance output of the monitors is inaccurate and should be noted with caution .


Delayed-release dimethyl fumarate ( DMF , also known as gastro-resistant DMF ) , demonstrated efficacy and safety in relapsing-remitting multiple sclerosis in the @-year , randomized , placebo-controlled , phase @ DEFINE and CONFIRM trials .


A post hoc analysis of integrated data from DEFINE and CONFIRM was conducted to determine the temporal profile of the clinical and neuroradiological effects of DMF .


Eligible patients were randomized to receive placebo , DMF @mg twice ( BID ) or three times ( TID ) daily or glatiramer acetate ( GA ; reference comparator ; CONFIRM only ) for up to @weeks .


Patients in the GA group were excluded from this analysis .


A total of @ patients were randomized and received treatment with placebo ( n = @ ) or DMF BID ( n = @ ) or TID ( n = @ ) .


DMF significantly reduced the annualized relapse rate beginning in weeks @-@ ( BID , P = @ ; TID , P = @ ) ; the proportion of patients relapsed beginning at week @ ( BID , P = @ ) and week @ ( TID , P = @ ) ; and the proportion of patients with @-week confirmed disability progression beginning at week @ ( BID , P = @ ) and week @ ( TID , P = @ ) , compared with placebo .


These effects were sustained throughout the @-year study period .


DMF significantly reduced the odds of having a higher number of gadolinium-enhancing lesions by @ % ( BID ) and @ % ( TID ) and the mean number of new or enlarging T@ lesions by @ % ( BID ) and @ % ( TID ) , from the first post-baseline magnetic resonance imaging assessment at @weeks ( all P < @ versus placebo ) .


In phase @ clinical trials , DMF demonstrated rapid and sustained clinical and neuroradiological efficacy in relapsing-remitting multiple sclerosis .


Repetitive transcranial magnetic stimulation ( rTMS ) is able to induce changes in neuronal activity that outlast stimulation .


The underlying mechanisms are not completely understood .


They might be analogous to long-term potentiation or depression , as the duration of the effects seems to implicate changes in synaptic plasticity .


Norepinephrine ( NE ) has been shown to play a crucial role in neuronal plasticity in the healthy and injured human brain .


Atomoxetine ( ATX ) and other NE reuptake inhibitors have been shown to increase excitability in different systems and to influence learning processes .


Thus , the combination of two facilitative interventions may lead to further increase in excitability and motor learning .


But in some cases homeostatic metaplasticity might protect the brain from harmful hyperexcitability .


In this study , the combination of @mg ATX and @Hz rTMS over the primary motor cortex was used to examine changes in cortical excitability and motor learning and to investigate their influence on synaptic plasticity mechanisms .


The results of this double-blind placebo-controlled study showed that ATX facilitated corticospinal and intracortical excitability in motor cortex .


@ Hertz rTMS applied during a motor task was able to further increase intracortical excitability only in combination with ATX .


In addition , only the combination of @Hz rTMS and ATX was capable of enhancing the total number of correct responses and reaction time significantly , indicating an interaction effect between rTMS and ATX without signs of homeostatic metaplasticity .


These results suggest that pharmacologically enhanced NE transmission and @Hz rTMS exert a synergistic effect on motor cortex excitability and motor learning in healthy humans .


To investigate whether self care behaviours , medical outcomes and quality of life of Taiwanese elderly with Type @ diabetes mellitus ( DM ) can be improved by delivery of an educational health care package .


DM is a major health problem in developed and developing countries , with older adults constituting about half of the diabetic population .


Type @ DM is the most rapidly increasing chronic disease in Taiwan .


During @ and @ , Taiwanese elderly with Type @ DM ( n = @ ) were randomly allocated to either an intervention or control group .


Data collection using validated instruments occurred at baseline and @ months follow-up .


Main outcome measures were blood glucose levels and diabetic complications .


At baseline , @ % participants in the control and @ % in the experimental group had a blood glucose level above normal range ( p = @ ) ; respective results at @ months were @ % for the control group and @ % for the experimental group ( p < @ ) .


The multivariate adjusted result showed that the intervention group was @ times less likely to have blood glucose levels above normal ( p = @ ) at @ months follow-up compared to the control group .


Occurrence of complications was significantly fewer in the intervention group at baseline and at @ month follow-up compared to the control group ( baseline : @ % versus @ % , p = @ ; @ month follow-up : @ % versus @ % ; p = @ ) .


Although overall occurrence of complications remained unchanged , the educational health care package specifically developed for Taiwanese elderly with Type @ DM improved blood glucose levels .


Transnasal esophagogastroduodenoscopy ( EGD ) without sedation has been reported to be safe and tolerable .


It has recently been used widely in Japan for the detection of upper gastrointestinal disease .


Alternatively , transoral examination using a thin endoscope has also been reported to be highly tolerable .


To examine the cardiocirculatory effects of transoral versus transnasal EGD in an attempt to determine the most suitable endoscopic methods for patients @ years of age .


Subjects who underwent monitoring of respiratory and circulatory dynamics without sedation during endoscopic screening examinations were enrolled at the New Ooe Hospital ( Kyoto , Japan ) between April @ and March @ .


A total of @ patients ( age @ years ) provided written informed consent and were investigated in the present study .


Patients were randomly divided into three subgroups : UO group -- thin endoscope ; SO group -- standard endoscope ; and UT group -- transnasal EGD .


Percutaneous arterial blood oxygen saturation , heart rate and blood pressure were evaluated just before EGD and at five time points during EGD .


After transnasal EGD , patients who had previously been examined using transoral EGD with a standard endoscope were asked about preferences for their next examination .


There were no statistical differences in the characteristics among the groups .


Percutaneous oxygen saturation in the UT group showed a transient drop compared with the SO and UO groups at the beginning of the endoscopic procedure .


Heart rate showed no significant differences among the SO , UO and UT groups ; Systolic blood pressure in the UO group was lower immediately after insertion compared with the SO and UT groups .


The rate pressure product in the UO group was comparable with that in the UT group during endoscopy , and the SO group showed a continuously higher level than the UO and UT groups .


More than one-half ( @ % ) of patients were ` willing to choose transnasal EGD for next examination ' .


For elderly patients , unsedated transnasal EGD failed to show an advantage over unsedated standard endoscopy .


Transoral thin EGD was estimated to be safe and tolerable .


Urethrocutaneous fistulae ( UCFs ) represent one of the most frequent causes of morbidity after urethroplasty .


Hypospadias can be repaired using different surgical techniques , but-regardless of technique-the incidence of UCF ranges between @ % and @ % .


Surgical repair of UCF remains the treatment of choice , even if some patients need further surgery because of recurrences .


Cyanoacrylates have been used as skin suture substitutes , and some evidence suggests a beneficial effect when these adhesives are used as an adjuvant in the management of UCF .


Here we describe the results of management of UCF using @-octyl cyanoacrylate ( OCA ) compared with surgical repair .


A randomized clinical trial conducted from January @ to December @ included @ children with UCF complications after urethroplasty for hypospadias .


Twenty-one children were assigned to receive OCA as ambulatory patients and @ were treated surgically .


The main outcome variable was closure of the UCF .


The estimated costs of both treatments were also calculated , as were absolute risk reduction ( ARR ) , relative risk reduction ( RRR ) and number needed to treat ( NNT ) to prevent a surgical intervention .


The mean numbers of UCF were @ in the OCA group ( n = @ ) and @ in the surgical group ( n = @ ) with no statistically significant difference .


The external orifices measured were @ @ mm and @ @ mm , respectively ( NS ) .


Sixty per cent of the UCFs treated with cyanoacrylate were completely closed and @ % of the surgical group healed completely ( NS ) .


More than one reoperation to improve complications was needed in the surgical group ( @ @ ) .


The clinical significance of the therapeutic usefulness of OCA was demonstrated by an ARR of @ , RRR of @ and NNT of @ to avoid further surgical treatment .


The total costs of adhesive applications and reoperations were $ US @,@ and $ US @,@ , respectively .


The results showed a similar success rate for both treatments .


However , sealant use should be considered before surgical treatment because this is a simple outpatient procedure with a reasonable success rate .


Alterations in the vocal folds that involve volume reduction and glottal closure failure result in exaggerated air escape during speech .


For such situations , the use of implants or grafts of different materials has been proposed .


To define the effect of sugarcane biopolymer gel when implanted in the vocal folds of rabbits .


This was an experimental study .


The vocal folds of rabbits injected with sugarcane biopolymer and saline solution were histologically evaluated after @ and @ days .


Mild to moderate inflammation and increased volume were observed in all vocal folds injected with biopolymer , when compared to controls .


There were no cases of necrosis or calcification .


This study showed higher inflammatory reaction in cases than in controls and biopolymer biointegration to the vocal fold .


This fibrogenic response with absence of epithelial repercussions suggests that the biopolymer in its gel form can be bioactive and preserve the normal vibratory function of the epithelium .


We show that in spite of producing an inflammatory reaction in vocal fold tissues , the material remained in vocal fold throughout the study period .


Despite growing interest in psychotherapy in child and adolescent headache , efficacy studies in this research field have focused mainly on cognitive-behavioral therapies .


Whereas relaxation and cognitive-behavioral techniques , in particular , have been found to reduce the intensity and frequency of headache in children and adolescents , data on psychodynamic psychotherapy in this population are lacking.Our aim was to explore the effectiveness of a brief psychodynamic psychotherapy program in the treatment of idiopathic headache in childhood and adolescence .


Thirty-three newly diagnosed idiopathic headache sufferers aged @-@ years , consecutively referred to our outpatient services , were randomized to receive either a brief cycle of psychodynamic psychotherapy ( eight sessions administered at two-week intervals ) or usual care ( clinical interview , neurological examination , counselling , symptomatic therapy ) .


The two groups were evaluated at baseline ( T@ ) and at six months ( T@ ) to be assessed for headache characteristics ( i.e. frequency , intensity and duration ) , quality of life ( i.e. the EuroQoL score ) , patient 's global health status ( i.e. the Clinical Global Impression score ) , and emotional-behavioral symptoms ( i.e. Child Behavior Checklist scores ) .


The two groups were fairly similar with reference to the main demographic and clinical variables .


The T@/T@ comparison showed a statistically significant improvement in headache frequency ( p = @ ) , intensity ( p < @ ) and duration ( p = @ ) , a statistically significant improvement in the CGI score ( p = @ ) , and a borderline improvement in the EuroQoL score ( p = @ ) in the group receiving psychotherapy .


According to our pilot findings , a brief psychodynamic psychotherapy program may be more effective than usual care in children and adolescents with idiopathic headache .


Quinolone-based regimens have been used as the rescue for eradication of Helicobacter pylori .


Sitafloxacin is known to have low minimum inhibitory concentration for H.pylori .


Here , we compared two sitafloxacin-based eradication regimens as rescue for the eradication of H.pylori .


We attempted to eradicate H.pylori in @ Japanese patients who had never failed in eradication of H.pylori with the triple proton pump inhibitor/amoxicillin/clarithromycin therapy ( @st line ) and the triple proton pump inhibitor/amoxicillin/metronidazole therapy ( @nd line ) .


They were assigned to either the triple therapy with rabeprazole @mg b.i.d. / q.i.d. , amoxicillin @mg q.i.d , and sitafloxacin @mg b.i.d. ( RAS ) for @ or @ weeks or the triple therapy with rabeprazole @mg b.i.d. / q.i.d. , metronidazole @mg b.i.d. , and sitafloxacin @mg b.i.d. ( RMS ) for @ or @ weeks .


Eradication was assessed via the ( @ ) C-urea breath test and rapid urease test .


Intention-to-treat and per-protocol analyses of eradication rates were @ % ( @/@ ) and @ % ( @/@ ) with RAS for @ week , @ % ( @/@ ) and @ % ( @/@ ) for RAS for @ weeks , @ % ( @/@ ) and @ % ( @/@ ) for @ week-RMS and @ % ( @/@ ) and @ % ( @/@ ) with RMS for @ weeks .


We noted no statistical significant differences in eradication rates among four regimens .


All of the above-described rescue regimens proved relatively equally useful in the eradication of H.pylori .


Of them , RAS for @ weeks and RMS for @ or @ weeks could attain the rescue eradication rates higher than @ % by per-protocol analysis .


To examine the efficacy of an integrative cognitive training program ( REHACOP ) to improve cognition , clinical symptoms , and functional disability of patients with Parkinson disease ( PD ) .


Forty-two patients diagnosed with PD in Hoehn & Yahr stages @ to @ were randomly assigned to either the cognitive training group ( REHACOP ) or the control group ( occupational activities ) for @ months ( @ sessions , @ min/wk ) .


Primary outcomes were change on processing speed , verbal memory , visual memory , executive functioning , and theory of mind .


Secondary outcomes included changes on neuropsychiatric symptoms , depression , apathy , and functional disability .


The trial was registered with clinicaltrials.gov ( NCT@ ) .


No baseline group differences were found .


Bootstrapped analysis of variance results showed significant differences in the mean change scores between the REHACOP group and control group in processing speed ( @ -LSB- SE = @ -RSB- vs -@ -LSB- SE = @ -RSB- , p = @ ) , visual memory ( @ -LSB- SE = @ -RSB- vs -@ -LSB- SE = @ -RSB- , p = @ ) , theory of mind ( @ -LSB- SE = @ -RSB- vs -@ -LSB- SE = @ -RSB- , p = @ ) , and functional disability ( -@ -LSB- SE = @ -RSB- vs @ -LSB- SE = @ -RSB- , p = @ ) .


Patients with PD receiving cognitive training with REHACOP demonstrated statistically significant and clinically meaningful changes in processing speed , visual memory , theory of mind , and functional disability .


Future studies should consider the long-term effect of this type of intervention .


These findings support the integration of cognitive training into the standard of care for patients with PD .


This study provides Class II evidence that for patients with PD , an integrative cognitive training program improves processing speed , visual memory , theory of mind , and functional disability .


Observational data indicate that carotid artery stenting ( CAS ) is associated with higher incidence of subclinical cerebral microemboli than carotid endarterectomy ( CEA ) .


We hypothesized that CEA would be associated with superior performance on detailed domain-specific cognitive testing compared with CAS .


Patients with > @ % asymptomatic carotid artery stenosis were randomized to CEA or CAS with side of stenosis balanced across condition .


A robust battery of tests was used to assess the cognitive domains of attention , memory , mood , visual-spatial skills , motor ability , processing speed , and executive functioning @ days preoperatively and postoperatively at @ weeks and @ months .


Tests were administered using standardized conditions and were scored by individuals blinded to treatment allocation .


Baseline cognitive performance was similar between CAS ( n = @ ) and CEA ( n = @ ) groups ( P > @ ) .


Relative to baseline , verbal and visual memory and attention functions substantially improved in the CAS and CEA groups at @ months ( multiple cognitive tests achieved statistical significance ) .


Compared with CEA , cognitive processing speed ( Stroop Color test : @ vs @ , P = @ ; and Stroop Word test : @ vs @ , P = @ ) was superior in the CAS group at @ weeks .


Executive functioning ( phonemic verbal fluency : @ vs @ , P = @ ) and motor function ( Grooved Pegboard of nondominant extremity : @ vs @ , P = @ ) were also superior in the CAS group at @ months .


Tests of attention , memory , and visual-spatial skills were similar between CAS and CEA patients at @ weeks and @ months .


Carotid revascularization improves memory and attention within the first @ postoperative months .


Compared with CEA , CAS produces improvements in cognitive processing speed , executive functioning , and motor function .


Health utilities measure patients ' preferences for a health state .


To assess health utilities for sofosbuvir-containing therapy for chronic hepatitis C.


The SF-@D utility scores were derived from the SF-@ instrument administered at baseline , during and post-treatment to participants of the previously reported clinical trials of sofosbuvir .


EQ-@D utility scores were also approximated from the SF-@ using a regression model .


Nine hundred and ninety-four patients were enrolled .


Baseline SF-@D and EQ-@D scores were @ @ and @ @ , respectively ( the POSITRON trial ) , @ @ and @ @ ( FISSION ) , @ @ and @ @ ( FUSION ) , @ @ and @ @ ( NEUTRINO ) .


In all studies , SF-@D and EQ-@D scores were highly correlated with each other .


( r = @-@ @ , P < @ ) .


After @ weeks , patients receiving sofosbuvir + ribavirin ( POSITRON ) had similar utility scores to placebo ( P > @ ) .


Patients receiving @ and @ weeks of sofosbuvir + ribavirin ( FUSION ) had similar utility scores ( P > @ ) .


In FISSION , patients receiving sofosbuvir + ribavirin had significantly better utilities compared to patients receiving interferon + ribavirin ( P < @ ) .


Patients receiving sofosbuvir + ribavirin + interferon ( NEUTRINO ) had a decrease in utilities during treatment ( SF-@D : from @ to @ , EQ-@D : @ to @ ; P < @ ) similar to that observed in patients receiving pegylated interferon + ribavirin for @ weeks in FISSION ( @ to @ and @ to @ , respectively , P < @ ) .


After @ weeks post-treatment , patients with SVR ( FUSION ) had improvement in SF-@D ( +@ from baseline , P = @ ) and EQ-@D ( +@ , P = @ ) .


In multivariate analyses , baseline depression , anxiety , fatigue , insomnia and treatment-related anaemia were the most consistent predictors of utilities .


Patients ' health utilities are minimally impacted by sofosbuvir + ribavirin treatment , as compared to interferon-based , therapy regardless of treatment duration .


Clinical trials ' numbers : NCT@ ( POSITRON ) , NCT@ ( FISSION ) , NCT@ ( FUSION ) , NCT@ ( NEUTRINO ) .


In our study , the efficiency and reliability of lidocaine ( @ cc/@ % ) application during transrectal ultrasound-guided ( TRUS ) prostate biopsy to levatores prostate was studied .


Levatores prostate was visualized on a cadaver dissection previously .


Eighty outpatients with lower urinary tract complaints or were suspected clinically to have prostate cancer were submitted to TRUS-guided prostate biopsy .


The ages of outpatients were ranging from @ to @ .


Patients were randomized in @ groups : Group-I , with @ patients submitted to local anesthesia by periprostatic injection of @ cc @ % lidocaine before biopsy ; and group-II , with @ controls the biopsy was performed without local anesthesia .


The anatomical region for anesthesia was determined via dissection .


The name of this anatomical region is levatores prostatae and it has got high nerve density .


The process was explained to the patients and their approvals were obtained .


Levatores prostatae was detected with TRUS before biopsy .


Pain ; related to digital rectal examination ( DRE ) , probe insertion or biopsy , was scored via visual analog scale ( VAS ) .


The patients were evaluated about side effects of lidocaine and early and late complications of biopsy as well .


Both groups were similar in terms of mean age , PSA levels , prostate volume and VAS scores ( p > @ ) .


As for VAS score , on the group submitted to anesthesia was determined @ @ , while for VAS score on the group submitted conventional biopsy was determined @ @ .


Between two groups , there was a statistical difference in terms of VSA score ( p < @ ) ; but there was no statistical difference about early and late complications of biopsy .


The periprostatic blockage use is clearly associated with more tolerance and patient comfort during TRUS-guided biopsy .


Owing to the local anesthesia introduced to the periprostatic nerve bundle localization in levatores prostate area , the patients could tolerate the pain better .


To assess the morbidity and efficacy of thermal tissue welder instrument for tonsillectomy and compare it with monopolar electrocautery .


IRB approval was obtained at the Wexner Medical Center at Ohio State University for a prospective , randomized , single-blinded , controlled clinical study of @ healthy adult volunteers undergoing tonsillectomy for chronic tonsillitis and tonsil hypertrophy .


Subjects were randomized to the TW or EC group .


Post-operative pain , pain medication use , return to normal oral intake , return to normal activity , and bleeding were measured on the post-operative log .


We recorded operative time , operating room time , and blood loss .


All procedures were performed by one surgeon to eliminate variations in time and experience .


Operative and patient data were analyzed using a Student T-test and evaluated by cost analysis .


There was a statically significant increase in operative time with the TW taking an average of @min longer per procedure , p < @ .


However , when total anesthesia time was compared , this did not translate into a statistically significant increase in total operating room time and therefore did not translate into additional cost .


The remaining categories were not significantly different between the two groups .


In @/@ TW cases , suction cautery was required for hemostasis .


Two patients had @ occurrences of secondary bleeding in the electrocautery group and none in the tissue welder group .


TW cost increase per case was $ @ per instrument but averaged $ @ per case .


While the tissue welder remains a viable option for the adult tonsillectomy procedure , it has not demonstrated in our study the necessary parameters intraoperatively , postoperatively , or via cost analysis to become the choice instrument at our institution .


We can not ignore the increase in cost that may be seen for short and routine procedures without an added benefit to the patient in terms of outcome or safety .


A larger study is needed to determine if secondary bleeding rates are lower with this instrument .


To determine the efficacy of @ % tacrolimus ointment in patients with perianal Crohn 's disease ( CD ) .


This prospective randomized trial enrolled @ patients with perianal CD as anal fissures and rectal fistulas .


The inclusion criteria were rectovaginal or extrasphincteric fistulas and purulent leakages .


A study group comprised @ patients , including @ with anal fissures and @ with fistulas .


A control group included @ patients , including @ with fissures and @ with fistulas .


The study group received systemic therapy with azathioprine @ mg/kg/day and tacrolimus ointment @ mg/day ; the control group had systemic therapy with azathioprine @ mg/kg/day , hormone ointment @ mg/day , and metronidazole suppositories @ mg/day .


Control examination and perianal CD activity index ( PCDAI ) determination were done @ and @ weeks after therapy initiation .


At @ weeks after beginning the study , local examination revealed the signs of anal fissure epithelialization in @ ( @ % ) of the @ patients in the study group and in @ ( @ % ) of the @ patients in the control one .


At @ weeks , fissure epithelialization and fistula obliteration were stated in @ ( @ % ) patients in the study group and in @ ( @ % ) of the @ patients in the control group .


At @ weeks , PCDAI in the study and control groups was @ and @ scores ( p = @ ) .


The findings suggest that topical @ % tacrolimus ointment versus antibacterial suppositories and hormone ointments is effective in treating patients with perianal CD .


Topical @ % tacrolimus ointment therapy caused a reduction in PCDAI .


Medication adherence is critical for transplant patients because the consequences of non-adherence can result in allograft loss and may be life threatening .


A prospective study with @ renal transplant recipients using a sequential control group design was performed to investigate the impact of a pharmaceutical intensified care programme led by a clinical pharmacist on daily drug adherence during the first year after renal transplantation .


Thirty-nine patients of the control group received the already established standardized drug and transplant training , while @ patients of the intensified care group ( ICG ) received additional inpatient and outpatient pharmaceutical care and counselling by a dedicated clinical pharmacist .


Applied interventions were clustered and classified using the behaviour change technique taxonomy according to Michie .


Adherence to immunosuppressive drug therapy was monitored up to @ year using a medication event monitoring system , pill count ( PC ) , drug holiday ( DH ) occurrence , Morisky questionnaire and self-report .


Sixty-seven patients ( @ of the standard care and @ of the ICG ) were analysed .


Implementation of DA was significantly ( P = @ ) improved in patients of the ICG ( @ % ) compared with SCG ( @ % ) during the first year after transplantion .


Daily adherence measures were already improved within @-@ days after start of intensified patient care and continued throughout the study period .


Intensified care patients also showed significantly better results for taking adherence ( P = @ ) , PC ( P = @ ) and DHs ( P = @ ) .


The additional , intensified pharmaceutical care improved patients ' medication adherence remarkably , suggesting that the applied additional care programme has the potential to improve outcomes after organ transplantation .


Postpartum hemorrhage ( PPH ) is one of the major preventable causes of maternal death in developing countries .


Although the non-parenteral use of misoprostol is a big advantage especially in home births , its benefits in prevention of PPH is still debating .


We aimed to assess the effect and side-effects of prophylactic oral , rectal or vaginal misoprostol on preventing postpartum hemorrhage comparing with no-treatment option .


In a randomized clinical trial , during uncomplicated vaginal delivery , @ women were assigned to receive one of the five treatment protocols in the third stage of labor which was managed routinely by early cord clamping and controlled cord traction .


Maternal hemoglobin and hematocrit values , the duration of the third stage , and the incidence of blood transfusion was recorded .


There was no statistically significant differences between the antepartum and postpartum values of hemoglobin or hematocrit between the groups .


The mean duration ( @ @ min ) of the third stage of labor in oral + vaginal group was significantly shorter .


Shivering was observed totally in @ women and the differences were not significant between groups .


Despite misoprostol has benefit in treatment of postpartum hemorrhage , it has no remarkable effect in prophylaxis of atony-induced postpartum hemorrhage .


To compare femtosecond laser-assisted cataract surgery with standard phacoemulsification concerning the incidence of postoperative clinical or subclinical macular edema and the correlation between macular thickness and postoperative intraocular inflammation values .


One hundred four eyes of @ patients were treated by laser-assisted cataract surgery and the fellow @ eyes underwent phacoemulsification using pulsed ultrasound energy and intraocular lens implantation in this prospective randomized study .


Laser flare photometry was measured preoperatively and at @ hours , @ to @ days , @ month , @ months , and @ months postoperatively .


Retinal thickness was measured by spectral-domain optical coherence tomography .


Two hundred two eyes ( @ % ) were included and analyzed at @ months postoperatively .


The mean center thickness in the laser group was @ @ m at @ days postoperatively , @ @ m at @ month postoperatively , @ @ m at @ months postoperatively , and @ @ m at @ months postoperatively .


The mean center thickness in the standard group was @ @ m at @ days postoperatively , @ @ m at @ month postoperatively , @ @ m at @ months postoperatively , and @ @ m at @ months postoperatively .


Laser flare photometry showed higher levels in the standard group at the first postoperative visit @ hours after surgery compared with the laser group .


Femtosecond laser-assisted cataract surgery did not obviously influence the incidence of postoperative macular edema .


To evaluate the effects of a bimatoprost/timolol fixed combination ( BTFC ) and a latanoprost/timolol fixed combination ( LTFC ) on diurnal intraocular pressure ( IOP ) and anterior ocular parameters in healthy subjects .


We enrolled @ healthy subjects in this prospective clinical study .


Thirty subjects were treated with BTFC and @ subjects were treated with LTFC .


IOP was measured every @ hours except from @:@ and @:@ .


Axial length , corneal curvature , and anterior chamber depth were obtained using the IOL master at baseline and @ hours later .


Adverse events were assessed by patient interview and by slit lamp examination .


The largest difference in IOP between treated and untreated eyes @ hours after instillation was @ mmHg in the BTFC group ( p < @ ) .


The largest difference in IOP between treated and untreated eyes @ hours after instillation was @ mmHg in the LTFC group ( p < @ ) .


For anterior ocular parameters such as axial length , corneal curvature , anterior chamber depth at baseline and @ hours after instillation , there were no significant differences between the baseline and @-hour values in either the BTFC or LTFC group .


The most frequently occurring adverse event was conjunctival hyperemia , which was found in @ % ( n = @ ) of the BTFC group and @ % ( n = @ ) of the LTFC group ( p = @ ) .


BTFC and LTFC provided a significant reduction in IOP from baseline without changing any anterior ocular parameters .


Our results provide a reference for monocular trials to assess the effect of eye drops in a clinical condition .


Thiazide diuretics are reported to have antioxidant effects and reduce pulse pressure ( PP ) .


The aim of this study was to elucidate whether hydrochlorothiazide additionally exerts such effects in stroke patients under treatment with losartan .


This study was an open-label , randomized , multicenter study .


Patients with a history of chronic stroke and treatment with angiotensin receptor blockers or angiotensin-converting enzyme inhibitors for essential hypertension were enrolled .


Fifty-five hypertensive patients were randomly assigned to two groups : those further treated with hydrochlorothiazide and those further treated with non-diuretic antihypertensive drugs .


Both groups showed a significant decrease in PP over six months ( hydrochlorothiazide group : @ mmHg to @ , p < @ ; non-diuretic group : @ to @ , p < @ ) , although no significant differences were observed between the two groups .


The malondialdehyde-modified low-density lipoprotein levels did not change significantly after treatment in either group .


In this study , hydrochlorothiazide treatment did not provide any additional benefits over non-diuretic antihypertensive drugs in terms of antioxidant effects or reducing PP .


Invasive hemodynamic exercise testing is commonly used in the evaluation of patients with suspected heart failure with preserved ejection fraction ( HFpEF ) or pulmonary hypertension .


Saline loading has been suggested as an alternative provocative maneuver , but the hemodynamic changes induced by the @ stresses have not been compared .


Twenty-six subjects ( aged , @ years ; n = @ HFpEF ; n = @ control ) underwent right heart catheterization at rest , during supine exercise , and with acute saline loading in a prospective study .


Exercise and saline each increased cardiac output and pressures in the right atrium , pulmonary artery , and pulmonary capillary wedge positions .


Changes in heart rate , blood pressure , rate-pressure product , and cardiac output were greater with exercise compared with saline .


In controls subjects , right atrial pressure , pulmonary arterial pressure , and pulmonary capillary wedge pressure increased similarly with saline and exercise , whereas in HFpEF subjects , exercise led to @-fold greater increases in right atrial pressure ( @ versus @ mm Hg ; P = @ ) , pulmonary arterial pressure ( @ versus @ mm Hg ; P = @ ) , and pulmonary capillary wedge pressure ( @ versus @ mm Hg ; P < @ ) compared with saline .


Systolic reserve assessed by stroke work and cardiac power output was lower in HFpEF subjects with both exercise and saline .


Systemic and pulmonary arterial compliances were enhanced with saline but reduced with exercise .


Exercise elicits greater pulmonary capillary wedge pressure elevation compared with saline in HFpEF but not controls , suggesting that hemodynamic stresses beyond passive stiffness and increased venous return explain the development of pulmonary venous hypertension in HFpEF .


Exercise testing is more sensitive than saline loading to detect hemodynamic derangements indicative of HFpEF .


The aim of this study was to evaluate DNA damage and cytokinetic defects , proliferative potential and cell death caused by the frequent use of mouthrinses containing chlorhexidine , triclosan and essential oils in ethanolic solution , compared to a placebo mouthwash .


This double-blind , prospective , randomized clinical trial included @ Caucasian patients .


Subjects were divided into four groups : Group I used a mouthrinse , Triclosan ; Group II used physiological saline ; Group III used chlorhexidine ; Group IV a mouthrinse with essential oils in ethanolic solution .


All subjects used the mouthrinses for two weeks ( @ ml , twice a day , rinsing for @s ) .


Two cell samples per subject were collected , before and after mouthrinse use ( on day @ and day @ ) .


Samples were processed as follows : cell collection from cheeks with a cytobrush ; cell centrifuge ; slide preparation , fixation and staining ; and fluorescent microscope analysis .


@ exfoliated cells were screened for nuclear abnormalities , particularly the presence of micronuclei by means of cytome assay .


No significant differences between study times ( before and after use of mouthwash ) were identified for any of the variables studied ( p > @ ) .


Differences between mouthrinse groups were also compared but no significant differences were found ( p > @ ) .


This study did not observe any genotoxic effect resulting from mouthrinse use .


Recent studies have shown that Gaviscon Double Action Liquid ( a combination alginate-antacid ) administered post-prandially co-localises with the acid pocket , the ` reservoir ' for post-prandial acid reflux .


To compare the effectiveness of Gaviscon Double Action Liquid to an equivalent strength antacid without alginate in controlling post-prandial acid reflux in GERD patients .


Fourteen GERD patients undertook two @-h high-resolution manometry/pH-impedance studies during which they ate a standardised meal .


In a double-blinded randomised crossover design they then took Gaviscon or CVS brand antacid , each with ~ @mmol/L acid neutralising capacity .


The primary outcome was distal oesophageal acid exposure ; secondary outcomes were number of reflux events , proximal extent of reflux , nadir pH of the refluxate , mechanism of reflux and reflux symptoms scored with a validated instrument .


Ten patients completed the study .


Gaviscon studies had significantly less distal oesophageal acid exposure and greater nadir refluxate pH in the @-@min post-prandial period than antacid studies .


There were no differences in the number of reflux events ( acid or weakly acidic ) or the number of proximal reflux events ( @-@cm above the LES ) with either study medication .


Gaviscon Double Action Liquid is more effective than an antacid without alginate in controlling post-prandial oesophageal acid exposure .


However , the number and spatial distribution of reflux events within the oesophagus are similar .


This suggests that Gaviscon main effectiveness relates to its co-localisation with and displacement/neutralisation of the post-prandial acid pocket , rather than preventing reflux .


To compare the differences of clinical effects in female patients with obesity and hyperlipidemia of yang deficiency of spleen and kidney syndrome between warm acupuncture combined with auricular acupuncture and simple warm acupuncture .


One hundred and thirty patients were randomly divided into an observation group and a control group , @ cases in each one .


In the control group , acupuncture was used at Pishu ( BL @ ) , Zhongwan ( CV @ ) , Shenshu ( BL @ ) , Zhongji ( CV @ ) , Guanyuan ( CV @ ) , Mingmen ( GV @ ) , Taibai ( SP @ ) , Fenglong ( ST @ ) , etc. ; warm acupuncture was applied at Pishu ( BL @ ) , Zhongwan ( CV @ ) , Shenshu ( BL @ ) and Zhongji ( CV @ ) ; the treatment was required once every two days and for @ months continuously .


In the observation group , based on the treatment in the control group , thumbtack intradermal needles were embedded at auricular points , including pi ( CO@ ) , shen ( CO@ ) , pangguang ( CO@ ) , sanjiao ( CO@ ) , neifenmi ( CO@ ) , neishengzhiqi ( TF@ ) , etc. .


Obesity indices -LSB- body mass ( W ) , obesity degree ( A ) , body mass index ( BMI ) , body fat percentage ( F % ) -RSB- blood lipid indices -LSB- serum total cholesterol ( TC ) , triglyceride ( TG ) , low density lipoprotein ( LDL-C ) , high density lipoprotein ( HDL-C ) -RSB- and clinical efficacy were observed before and after treatment in the two groups .


Results After treatment in the two groups , the obesity indices of W , A , BMI , F % and the blood lipid levels of TC , TG , LDL-C were obviously decreased compared with those before treatment ( all P < @ ) and the HDL-C levels were apparently increased than those before treatment ( both P < @ ) .


After treatment , the improvement of TC and HDL-C in the observation group was superior to that in the control group ( both P < @ ) .


The difference was not statistically significant in the aspect of improving every obesity index between two groups ( all P > .


The comprehensive total effective rate of the observation group was @ % ( @/@ ) , which was better than @ % ( @/@ ) of the control group ( P < @ ) .


Warm acupuncture combined with auricular acupuncture and simple warm acupuncture can both benignly adjust abnormal lipid metabolism of obesity patients with hyperlipidemia , and warm acupuncture combined with auricular acupuncture are superior to simple warm acupuncture treatment on antiobesity action and improving the TC and HDL-C levels .


Increasing cases of diabetes , a general lack of routinely operational prevention , and a long history of separating disease prevention and treatment call for immediate engagement of frontier clinicians .


This applies especially to village doctors who work in rural China where the majority of the nation 's vast population lives .


This study aims to develop and test an online Smart Web Aid for Preventing Type @ Diabetes ( SWAP-DM@ ) capable of addressing major barriers to applying proven interventions and integrating diabetes prevention into routine medical care .


Development of SWAP-DM@ used evolutionary prototyping .


The design of the initial system was followed by refinement cycles featuring dynamic interaction between development of practical and effective standardized operation procedures ( SOPs ) for diabetes prevention and Web-based assistance for implementing the SOPs .


The resulting SOPs incorporated proven diabetes prevention practices in a synergetic way .


SWAP-DM@ provided support to village doctors ranging from simple educational webpages and record maintenance to relatively sophisticated risk scoring and personalized counseling .


Evaluation of SWAP-DM@ used data collected at baseline and @-month follow-up assessment : ( @ ) audio recordings of service encounters ; ( @ ) structured exit surveys of patients ' knowledge , self-efficacy , and satisfaction ; ( @ ) measurement of fasting glucose , body mass index , and blood pressure ; and ( @ ) qualitative interviews with doctors and patients .


Data analysis included ( @ ) descriptive statistics of patients who received SWAP-DM@-assisted prevention and those newly diagnosed with prediabetes and diabetes ; ( @ ) comparison of the variables assessed between baseline and follow-up assessment ; and ( @ ) narratives of qualitative data .


The @ participating village doctors identified @ patients with elevated diabetes risk .


Of these , @ % ( @/@ ) consented to a fasting glucose test with @ new prediabetes and @ new diabetes diagnoses made within @ months .


The prediabetic patients showed substantial improvement from baseline to @-month follow-up in vegetable intake ( @ % , @/@ vs @ % , @/@ ) , calorie intake ( @ % , @/@ vs @ % , @/@ ) , leisure-time exercises ( @ % , @/@ vs @ % , @/@ ) , body weight ( mean @ kg , SD @ vs mean @ kg , SD @ ) , and body mass index ( mean @ kg/m ( @ ) , SD @ vs mean @ kg/m ( @ ) , SD @ ) .


The prediabetic patients showed improvement in self-efficacy for modifying diet ( mean @ , SD @ vs mean @ , SD @ ) , increasing physical activities ( mean @ , SD @ vs mean @ , SD @ ) , engaging relatives ( mean @ , SD @ vs mean @ , SD @ ) , and knowledge about diabetes and risks of an imbalanced diet and inadequate physical activity .


Most participating doctors and patients viewed SWAP-DM@ as useful and effective .


SWAP-DM@ is helpful to village doctors , acceptable to patients , and effective in modifying immediate determinants of diabetes at least in the short term , and may provide a useful solution to the general lack of participation in diabetes prevention by frontier clinicians in rural China .


To assess long-term safety and efficacy of fingolimod in patients with relapsing-remitting multiple sclerosis ( RRMS ) .


Patients completing FTY@ Research Evaluating Effects of Daily Oral Therapy in MS ( FREEDOMS ) were eligible for this dose-blinded , parallel-group extension study , continuing fingolimod @ mg/day or @ mg/day , or switching from placebo to either dose , randomized @:@ .


Efficacy variables included annualized relapse rate ( ARR ) , brain volume loss ( BVL ) , and confirmed disability progression ( CDP ) .


Between-group analyses were conducted in the intent-to-treat ( ITT ) population from FREEDOMS baseline to end of study .


Within-group analyses compared years @-@ ( FREEDOMS ) and years @-@ ( extension ) in the extension ITT population .


Of @,@ patients ( FREEDOMS ITT population ) , @,@ were eligible , and @ enrolled in the extension study ( continuous-fingolimod : @ mg -LSB- n = @ -RSB- , @ mg -LSB- n = @ -RSB- ; placebo-fingolimod : @ mg -LSB- n = @ -RSB- , @ mg -LSB- n = @ -RSB- ) ; @ formed the extension ITT population ( n = @ ; n = @ ; n = @ ; n = @ ) and @ ( @ % ) completed .


In the continuous-fingolimod groups , ARR was lower ( p < @ ) , BVL was reduced ( p < @ ) , and proportionately more patients were free from @-month CDP ( p < @ ) than in a group comprising all placebo-fingolimod patients .


Within each placebo-fingolimod group , ARR was lower ( p < @ , both ) and BVL was reduced after switching ( p < @ , placebo-fingolimod @ mg ) .


Rates and types of adverse events were similar across groups ; no new safety issues were reported .


Efficacy benefits of fingolimod during FREEDOMS were sustained during the extension ; ARR and BVL were reduced after switching .


This study provides Class IV evidence that long-term fingolimod treatment is well-tolerated and reduces relapse rates , disability progression , and MRI effects in patients with RRMS .


This study examines neurocognitive functioning in a large , well-characterized sample of homeless adults with mental illness and assesses demographic and clinical factors associated with neurocognitive performance .


A total of @ homeless adults with mental illness enrolled in the At Home Chez Soi study completed neuropsychological measures assessing speed of information processing , memory , and executive functioning .


Sociodemographic and clinical data were also collected .


Linear regression analyses were conducted to examine factors associated with neurocognitive performance .


Approximately half of our sample met criteria for psychosis , major depressive disorder , and alcohol or substance use disorder , and nearly half had experienced severe traumatic brain injury .


Overall , @ % of participants demonstrated cognitive impairment , including deficits in processing speed ( @ % ) , verbal learning ( @ % ) and recall ( @ % ) , and executive functioning ( @ % ) .


The overall statistical model explained @ % of the variance in the neurocognitive summary score , with reduced neurocognitive performance associated with older age , lower education , first language other than English or French , Black or Other ethnicity , and the presence of psychosis .


Homeless adults with mental illness experience impairment in multiple neuropsychological domains .


Much of the variance in our sample 's cognitive performance remains unexplained , highlighting the need for further research in the mechanisms underlying cognitive impairment in this population .


Paracetamol poisoning is common worldwide .


It is treated with intravenous acetylcysteine , but the standard regimen is complex and associated with frequent adverse effects related to concentration , which can cause treatment interruption .


We aimed to ascertain whether adverse effects could be reduced with either a shorter modified acetylcysteine schedule , antiemetic pretreatment , or both .


We undertook a double-blind , randomised factorial study at three UK hospitals , between Sept @ , @ , and Dec @ , @ .


We randomly allocated patients with acute paracetamol overdose to either the standard intravenous acetylcysteine regimen ( duration @ h ) or a shorter ( @ h ) modified protocol , with or without intravenous ondansetron pretreatment ( @ mg ) .


Masking was achieved by infusion of @ % dextrose ( during acetylcysteine delivery ) or saline ( for antiemetic pretreatment ) .


Randomisation was done via the internet and included a minimisation procedure by prognostic factors .


The primary outcome was absence of vomiting , retching , or need for rescue antiemetic treatment at @ h. Prespecified secondary outcomes included a greater than @ % increase in alanine aminotransferase activity over the admission value .


Analysis was by intention to treat .


This trial is registered with ClinicalTrials.gov ( identifier NCT@ ) .


Of @ patients who underwent randomisation , @ were assessable @ h after the start of acetylcysteine treatment .


Vomiting , retching , or need for rescue antiemetic treatment at @ h was reported in @ of @ patients assigned to the shorter modified protocol compared with @ of @ allocated to the standard acetylcysteine regimen ( adjusted odds ratio @ , @ % CI @-@ ; p < @ ) , and in @ of @ patients who received ondansetron compared with @ of @ allocated placebo ( @ , @-@ ; p = @ ) .


Severe anaphylactoid reactions were recorded in five patients assigned to the shorter modified acetylcysteine regimen versus @ who were allocated to the standard protocol ( adjusted common odds ratio @ , @ % CI @-@ ; p < @ ) .


The proportion of patients with a @ % increase in alanine aminotransferase activity did not differ between the standard ( @/@ ) and shorter modified ( @/@ ) regimens ( adjusted odds ratio @ , @ % CI @-@ ) ; however , the proportion was higher with ondansetron ( @/@ ) than with placebo ( @/@ ; @ , @-@ ; p = @ ) .


In patients with paracetamol poisoning , a @ h modified acetylcysteine regimen resulted in less vomiting , fewer anaphylactoid reactions , and reduced need for treatment interruption .


This study was not powered to detect non-inferiority of the shorter protocol versus the standard approach ; therefore , further research is needed to confirm the efficacy of the @ h modified acetylcysteine regimen .


The presence of anxiety disorders is associated with poorer alcohol use disorder treatment outcomes , but little is known about the impact of alcohol use problems on anxiety disorder treatment outcomes despite their high comorbidity .


The current study examined the impact of alcohol use symptom severity on anxiety disorder treatment outcomes in a multi-site primary care effectiveness study of anxiety disorder treatment .


Data came from the Coordinated Anxiety Learning and Management ( CALM ) effectiveness trial .


Participants ( N = @ ) were randomized to an evidence-based anxiety intervention ( including cognitive behavioral therapy and medications ) or usual care in primary care .


Participants completed measures of alcohol use , anxiety , and depression at baseline , @ - , @ - , and @-month follow-up periods .


Patients with alcohol dependence were excluded .


There were no significant moderating ( Treatment Group Alcohol Use Severity ) interactions .


The majority of analyses revealed no predictive effects of alcohol use severity on outcome ; however , alcohol problems at baseline were associated with somewhat higher anxiety and depression symptoms at the @-month follow-up .


These data indicate that patients with alcohol problems in primary care can be effectively treated for anxiety disorders .


Baseline alcohol problems were associated with some poorer long-term outcomes , but this was evident across CALM and usual care .


These findings provide preliminary evidence that there may be no need to postpone treatment of anxiety disorders until alcohol problems are addressed , at least among those who have mild to moderate alcohol problems .


Replication with more severe alcohol use disorders is needed .


To evaluate the effectiveness of nebulized mucolytic therapy ( N-acetylcysteine ) in treatment of children with acute bronchiolitis .


Prospective randomized , controlled study .


Paediatric Medical Unit of the Children 's Hospital and the Institute of Child Health , Lahore , from November @ to April @ .


All the patients aged @ months to @ months , with the diagnosis of acute viral bronchiolitis were enrolled in the study .


A predesigned proforma was completed after taking parental consent .


All eligible patients were randomly assigned to one of the two groups : group-@ received N-acetylcysteine in nebulized form , and group-@ received salbutamol as a nebulized aerosol .


Both groups were then compared regarding their clinical improvement and duration of stay in the hospital .


The data obtained was analyzed on the statistical software SPSS version @ .


Descriptive statistics were obtained by frequencies and percentages .


Chi-square test was applied to find p-value .


A total of @ patients met the inclusion criteria .


The mean age was @ months .


On the first day of treatment , the mean clinical severity score at baseline were @ @ in group-@ and @ @ in group-@ .


At day @ and @ , it was @ @ and @ @ in group-@ and @ @ and @ @ in group-@ respectively .


The clinical severity score after N-acetylcysteine inhalation therapy was better in group-@ on the third but more so on fifth day after hospital admission .


The mean duration of hospitalization was @ @ days for the whole population and it differed between the @ groups : @ @ days in group-@ versus @ @ days in group-@ .


On the basis of improvement in clinical severity score and early discharge from the hospital , N-acetylcysteine was found to be an effective therapy in acute bronchiolitis .


For patients with active moderate-to-severe Graves ' ophthalmopathy ( GO ) , a course of @ g iv glucocorticoids ( GCs ) is the recommended therapy .


The weekly protocol is preferred because of the potential safety concerns with the daily protocol .


However , evidence for the superiority of different administration protocols is lacking .


We conducted a prospective , randomized trial to compare the efficacy and safety of two protocols of iv @ g methylprednisolone in a total of @ patients in our institute .


The patients were randomized to receive iv methylprednisolone weekly or daily .