Several multiple regression models were constructed to determine independent predictors of the endpoint of death , myocardial infarction ( MI ) ( excluding periprocedural MI ) and non-ST-segment elevation acute coronary syndromes ( NSTE-ACS ) .


Ischemic burden during stress SPECT , anatomic burden derived from angiography , left ventricular ejection fraction , and assignment to either optimal medical therapy ( OMT ) + percutaneous coronary intervention ( PCI ) or OMT alone were analyzed .


In nonadjusted and adjusted regression models , anatomic burden and left ventricular ejection fraction were consistent predictors of death , MI , and NSTE-ACS , whereas ischemic burden and treatment assignment were not .


There was a marginal ( p = @ ) effect of the interaction term of anatomic and ischemic burden for the prediction of clinical outcome , but separately or in combination , neither anatomy nor ischemia interacted with therapeutic strategy to predict outcome .


In a cohort of patients treated with OMT , anatomic burden was a consistent predictor of death , MI , and NSTE-ACS , whereas ischemic burden was not .


Importantly , neither determination , even in combination , identified a patient profile benefiting preferentially from an invasive therapeutic strategy .


( Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation -LSB- COURAGE -RSB- ; NCT@ ) .


Microvascular angina ( MVA ) is characterized by anginal chest pain , an abnormal stress test , and normal coronary arteries on coronary angiography .


Although the exact pathogenesis remains unclear , endothelial dysfunction is a contributing factor .


To date , there exists no specific therapy for this disease .


Phosphodiesterase-@ inhibitor improves the endothelial function and subsequently microvascular circulation .


The aim of this study is to identify whether udenafil offers benefits in the treatment of MVA in female patients , who have a perfusion defect in their cardiac magnetic resonance image ( CMR ) , but normal coronary arteries .


The ` Understanding of Chest Pain in Microvascular Disease Proved by Cardiac Magnetic Resonance Image : ( UMPIRE ) ' trial is a multicenter , prospective , randomized , placebo controlled trial , designed to evaluate the effect of udenafil on myocardial ischemia and symptoms in female patients with MVA .


The myocardial ischemia will be quantified by myocardial stress perfusion defect in CMR .


A total of @ patients with proven perfusion defect in adenosine-stress CMR will be randomly assigned to either the udenafil treatment group ( daily dose of @mg ) or the placebo group for three months .


The primary endpoint is > @ % improvement in perfusion defect size in adenosine-stress CMR from baseline .


The secondary endpoints include < @ % improvement in perfusion defect size , chest pain frequency , ST depression in stress test , Duke score in stress test , quality of life ( QoL ) assessment by SF-@ questionnaire , sexual dysfunction assessment by BISF-W ( Brief Index of Sexual Functioning for Women ) self-assessment questionnaire , and biomarkers for endothelial function .


The UMPIRE trial is the first randomized controlled trial to evaluate the efficacy of udenafil in female MVA patients .


If udenafil demonstrates cardioprotective effects , it may provide a novel therapeutic option to reduce myocardial ischemia and improve cardiac function in female MVA patients .


Because human bone marrow ( BM ) CD@ + stem cells home into damaged tissue and may play an important role in tissue repair , this pilot clinical trial explored the safety and feasibility of intravitreal autologous CD@ + BM cells as potential therapy for ischemic or degenerative retinal conditions .


This prospective study enrolled six subjects ( six eyes ) with irreversible vision loss from retinal vascular occlusion , hereditary or nonexudative age-related macular degeneration , or retinitis pigmentosa .


CD@ + cells were isolated under Good Manufacturing Practice conditions from the mononuclear cellular fraction of the BM aspirate using a CliniMACs magnetic cell sorter .


After intravitreal CD@ + cell injection , serial ophthalmic examinations , microperimetry/perimetry , fluorescein angiography , electroretinography ( ERG ) , optical coherence tomography ( OCT ) , and adaptive optics OCT were performed during the @-month follow-up .


A mean of @ million ( range , @-@ million ) CD@ + cells were isolated and injected per eye .


The therapy was well tolerated with no intraocular inflammation or hyperproliferation .


Best-corrected visual acuity and full-field ERG showed no worsening after @ months .


Clinical examination also showed no worsening during follow-up except among age-related macular degeneration subjects in whom mild progression of geographic atrophy was noted in both the study eye and contralateral eye at @-month follow-up , concurrent with some possible decline on multifocal ERG and microperimetry .


Cellular in vivo imaging using adaptive optics OCT showed changes suggestive of new cellular incorporation into the macula of the hereditary macular degeneration study eye .


Intravitreal autologous BM CD@ + cell therapy appears feasible and well tolerated in eyes with ischemic or degenerative retinal conditions and merits further exploration .


( ClinicalTrials.gov number , NCT@ . )


The availability of different styles of silicone gel implants-including traditional round devices and shaped , form-stable implants-offers a variety of choices for women undergoing breast augmentation and reconstruction .


The purpose of this analysis was to characterize clinical outcomes associated with the Mentor MemoryGel ( round ) MemoryShape/Contour Profile Gel ( shaped ) devices through @ years of use in women undergoing breast augmentation or reconstruction .


The Mentor Core studies are nonrandomized , open-label clinical trials designed to assess the long-term safety and efficacy of silicone gel breast implants .


The cumulative incidence of selected complications and reoperations was estimated using the Kaplan-Meier method .


Patient satisfaction was assessed by asking the patient if she would decide to have breast implant surgery again .


Shaped implants were associated with lower cumulative incidence rates of Baker Grade III/IV capsular contracture compared with round implants ( @ % vs @ % , respectively , in primary augmentation , P < @ ; @ % vs @ % in revision-augmentation , P < @ ) .


Reoperation , explantation , and infection rates were comparable between devices across cohorts , except for lower incidence of infection with shaped than round implants in primary reconstruction ( @ % vs @ % , P < @ ) .


Rupture rates were lower with shaped implants , with significance reached in primary augmentation patients at @ years ( @ % vs @ % , P < @ ) .


High levels of patient satisfaction ( exceeding @ % ) with both devices were reported at @ years across cohorts .


Prospective data through @ years support comparable safety of round and shaped breast implants , and high levels of patient satisfaction , in patients undergoing primary and revision breast augmentation and reconstruction .


Obesity is prevalent in individuals with serious mental illness ( SMI ) .


The purpose of this study is to examine the feasibility of a telephone-delivered physical activity ( PA ) intervention for outpatients with serious mental illness to maintain PA and to explore the preliminary efficacy of the intervention on health status .


This study used a randomized experimental design .


The treatment group received pedometers and eight weekly phone calls ; the control group received written information regarding PA. .


Descriptive statistics were used to analyze data collected at baseline and @ weeks .


Twenty-two subjects with SMI ( mean age = @ @ years ; @ % were male ) were recruited and @ subjects completed the study in @ weeks .


PA ( z = -@ , p = @ ) increased in the treatment group ( n = @ ) whereas the control group ( n = @ ) maintained baseline PA level ( z = -@ , p = @ ) .


Health outcomes were not changed ( ps > @ ) .


Telephone-delivered intervention is feasible and has the potential to improve PA in individuals with SMI .


To observe the myocardial protective effect of electroacupuncture ( EA ) at Neiguan ( PC @ ) in the patients with valve replacement via extracorporeal circulation .


Fifty patients of rheumatic cardiac disease planned for valve replacement were graded as II or III level according to America Society of Anesthesiologists ( ASA ) and were randomized into an observation group and a control group , @ cases in each one .


The same anesthesia and valve replacement via extracorporeal circulation were adopted in the patients of the two groups .


In the observation group , @ min before operation , EA was used to stimulate bilateral Neiguan ( PC @ ) till the end of operation .


The venous blood was collected at @ time points separately , named before aorta blockage ( T@ ) , @ min after aorta open ( T@ ) , @ min after aorta open ( T@ ) , @ h after opening ( T@ ) and @ h after opening ( T@ ) .


The concentrations of malondial dehyde ( MDA ) , superoxide dismutase ( SOD ) and cardiac troponin @ ( cTnI ) were determined in serum .


The heart re-beating and the total dosage of vasoactive drugs after operation were recorded .


Compared with those before aorta blockage , MDA and cTnI at each time point of aorta open were all apparently increased in the patients of the two groups ( all P < @ ) , and SOD was reduced apparently ( P < @ ) .


Compared with the control group , at the time points from T@ to T@ , MDA and cTnL were lower apparently in the observation group as compared with those in the control group ( all P < @ ) and SOD was higher than that in the control group ( P < @ ) .


The dosage of vasoactive drugs was reduced apparently ( P < .


EA at Neiguan ( PC @ ) alleviates oxidative stress injury and has the protective effect on ischemic reperfusion myocardium .


Although gastrointestinal ( GI ) , respiratory , and dermal symptoms are common , few studies have conducted concurrent and comparative prospective analyses of risk factors for these @ morbidity outcomes .


We used data from a community-based randomized controlled trial among @ South Australian families to analyze GI ( diarrhea , vomiting ) , respiratory ( sore throat , runny nose , cough ) and dermal ( rash , generalized itch , dermal infection ) symptoms .


Log-binomial regression analysis revealed similar risks of GI ( adjusted risk ratio -LSB- RR -RSB- , @ ; @ % CI , @-@ @ ) and respiratory ( RR , @ ; @ % CI , @-@ @ ) symptoms among childcare/kindergarten attendees .


Swimming in public pools/spas in the current or previous week was associated with all @ symptom complexes , conferring similar risk for each ( RR for GI : @ ; @ % CI , @-@ @ ; respiratory : @ ; @ % CI , @-@ @ ; dermal : @ ; @ % CI , @-@ @ ) .


Pet ownership was not associated with symptoms .


Household clustering of GI and respiratory symptoms was common , and clustering of respiratory symptoms correlated with number of individuals per household .


This simultaneous examination of risk factors for @ health outcomes yielded new comparative data that are useful for developing prevention strategies .


Rather than the absolute dose of diuretic or urine output , the primary signal of interest when evaluating diuretic responsiveness is the efficiency with which the kidneys can produce urine after a given dose of diuretic .


As a result , we hypothesized that a metric of diuretic efficiency ( DE ) would capture distinct prognostic information beyond that of raw fluid output or diuretic dose .


We independently analyzed @ cohorts : ( @ ) consecutive admissions at the University of Pennsylvania ( Penn ) with a primary discharge diagnosis of heart failure ( n = @ ) and ( @ ) patients in the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness ( ESCAPE ) data set ( n = @ ) .


DE was estimated as the net fluid output produced per @ mg of furosemide equivalents , then dichotomized into high versus low DE based on the median value .


There was only a moderate correlation between DE and both intravenous diuretic dose and net fluid output ( r ( @ ) @ for all comparisons ) , indicating that DE was describing unique information .


With the exception of metrics of renal function and preadmission diuretic therapy , traditional baseline characteristics , including right heart catheterization variables , were not consistently associated with DE .


Low DE was associated with worsened survival even after adjusting for in-hospital diuretic dose , fluid output , in addition to baseline characteristics ( Penn : hazards ratio -LSB- HR -RSB- , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P = @ ; ESCAPE : HR , @ ; @ % CI , @-@ @ ; P = @ ) .


Although in need of validation in less-selected populations , low DE during decongestive therapy portends poorer long-term outcomes above and beyond traditional prognostic factors in patients hospitalized with decompensated heart failure .


Whether remote ischemic preconditioning ( transient ischemia and reperfusion of the arm ) can improve clinical outcomes in patients undergoing coronary-artery bypass graft ( CABG ) surgery is not known .


We investigated this question in a randomized trial .


We conducted a multicenter , sham-controlled trial involving adults at increased surgical risk who were undergoing on-pump CABG ( with or without valve surgery ) with blood cardioplegia .


After anesthesia induction and before surgical incision , patients were randomly assigned to remote ischemic preconditioning ( four @-minute inflations and deflations of a standard blood-pressure cuff on the upper arm ) or sham conditioning ( control group ) .


Anesthetic management and perioperative care were not standardized .


The combined primary end point was death from cardiovascular causes , nonfatal myocardial infarction , coronary revascularization , or stroke , assessed @ months after randomization .


We enrolled a total of @ patients ( @ in the control group and @ in the ischemic-preconditioning group ) at @ cardiac surgery centers in the United Kingdom .


There was no significant difference in the cumulative incidence of the primary end point at @ months between the patients in the remote ischemic preconditioning group and those in the control group ( @ patients -LSB- @ % -RSB- and @ patients -LSB- @ % -RSB- , respectively ; hazard ratio with ischemic preconditioning , @ ; @ % confidence interval , @ to @ ; P = @ ) .


Furthermore , there were no significant between-group differences in either adverse events or the secondary end points of perioperative myocardial injury ( assessed on the basis of the area under the curve for the high-sensitivity assay of serum troponin T at @ hours ) , inotrope score ( calculated from the maximum dose of the individual inotropic agents administered in the first @ days after surgery ) , acute kidney injury , duration of stay in the intensive care unit and hospital , distance on the @-minute walk test , and quality of life .


Remote ischemic preconditioning did not improve clinical outcomes in patients undergoing elective on-pump CABG with or without valve surgery .


( Funded by the Efficacy and Mechanism Evaluation Program -LSB- a Medical Research Council and National Institute of Health Research partnership -RSB- and the British Heart Foundation ; ERICCA ClinicalTrials.gov number , NCT@ . )


To study the efficacy of early , enough methylprednisone combined with immunoglobulin in treatments of severe hand-foot-mouth disease .


@ patients of severe hand-foot-mouth disease involved were randomized into group A and group B. Patients of both groups all accepted symptomatic treatment , supportive therapy and the treatment of control intracranial pressure .


And patients in group A received the treatment of early , enough methylprednisone combined with immunoglobulin , whereas patients in group B received conventional therapy .


RESULTS ; Curative rate of group A was better than that of group B , otherwise incidence rate of critical illness was less than that of group B.


The control time of fever , erythra , neurological symptoms , features of pneumonia and increased leukocyte of group A was shorter than that of group B , and no more recent or Long-term treatment-related adverse reaction in group A.


Early , enough methylprednisone combined with immunoglobulin is effective , safe in treating severe hand-foot-mouth disease , and worthy to recommand its clinical use .


The individual placement and support model of supported employment has been shown to be more effective than other vocational approaches in improving competitive work over @-@ years in persons with severe mental illness .


The authors evaluated the longer-term effects of the model compared with traditional vocational rehabilitation over @ years .


A randomized controlled trial compared supported employment to traditional vocational rehabilitation in @ unemployed persons with severe mental illness .


Competitive work and hospital admissions were tracked for @ years , and interviews were conducted at @ and @ years to assess recovery attitudes and quality of life .


A cost-benefit analysis compared program and total treatment costs to earnings from competitive employment .


The beneficial effects of supported employment on work at @ years were sustained over the @-year follow-up period .


Participants in supported employment were more likely to obtain competitive work than those in traditional vocational rehabilitation ( @ % compared with @ % ) , worked more hours and weeks , earned more wages , and had longer job tenures .


Reliance on supported employment services for retaining competitive work decreased from @ years to @ years for participants in supported employment .


Participants were also significantly less likely to be hospitalized , had fewer psychiatric hospital admissions , and spent fewer days in the hospital .


The social return on investment was higher for supported employment participants , whether calculated as the ratio of work earnings to vocational program costs or of work earnings to total vocational program and mental health treatment costs .


The results demonstrate that the greater effectiveness of supported employment in improving competitive work outcomes is sustained beyond @ years and suggest that supported employment programs contribute to reduced hospitalizations and produce a higher social return on investment .


Fructose consumption has risen alongside obesity and diabetes .


Gut hormones involved in hunger and satiety ( ghrelin and PYY ) may respond differently to fructose compared with glucose ingestion .


This study evaluated the effects of glucose and fructose ingestion on ghrelin and PYY in lean and obese adolescents with differing insulin sensitivity .


Adolescents were divided into lean ( n = @ ) , obese insulin sensitive ( n = @ ) ( OIS ) , and obese insulin resistant ( n = @ ) ( OIR ) .


In a double-blind , cross-over design , subjects drank @ g of glucose or fructose in random order , serum was obtained every @ minutes for @ minutes .


Baseline acyl-ghrelin was highest in lean and lowest in OIR ( P = @ ) .


After glucose ingestion , acyl-ghrelin decreased similarly in lean and OIS but was lower in OIR ( vs. lean , P = @ ) .


Suppression differences were more pronounced after fructose ( lean vs. OIS , P = @ , lean vs. OIR , P < @ ) .


OIS became significantly hungrier after fructose ( P = @ ) .


PYY was not significantly different at baseline , varied minimally after glucose , and rose after fructose .


Compared with lean , OIS adolescents have impaired acyl-ghrelin responses to fructose but not glucose , whereas OIR adolescents have blunted responses to both .


Diminished suppression of acyl-ghrelin in childhood obesity , particularly if accompanied by insulin resistance , may promote hunger and overeating .


To test the hypothesis that radiotherapy ( RT ) of head and neck squamous cell carcinoma ( HNSCC ) can be improved by hypoxic modification using nimorazole ( NIM ) in association with accelerated fractionation .


The protocol was activated in March @ as an international multicenter randomized trial in patients with HNSCC .


Tumors were treated to a dose of @-@Gy , @-@ fractions , @ fractions per week .


NIM was administered in a dose of @ gperm ( @ ) , @min before the first daily RT fraction .


The primary endpoint was loco-regional failure .


The trial was closed prematurely by June @ due to poor recruitment .


An associated quality assurance program was performed to ensure the consistency of RT with the protocol guidelines .


The trial was dimensioned to include @ patients in @years , but only @ patients were randomized between March @ and May @ due to the inability to involve three major centers and the insufficient recruitment rate from the other participating centers .


Twenty patients from two centers had to be excluded from the analysis due to the unavailability of the follow-up data .


Among the remaining @ patients , @ patients were evaluable ( @ and @ patients in the RT+NIM and the RT-alone arms , respectively ) .


The treatment compliance was good with only six patients not completing the full planned RT course , and @ patients ( @ % ) out of @ allocated for NIM , achieving at least @ % of the prescribed drug dose .


At the time of evaluation , @ patients had failed to achieve persistent loco-regional tumor control , and a total of @ patients had died .


The use of NIM improved the loco-regional tumor control with an @month post-randomization cumulative failure rate of @ % versus @ % in the control arm , yielding a risk difference of @ % ( CI -@ % to @ % ; P = @ ) .


The corresponding values for overall death was @ % versus @ % , yielding a risk difference of @ % ( CI -@ % to @ % ; P = @ ) .


Sixteen patients , out of @ patients analyzed for hypoxic gene expression , were classified as having more hypoxic tumors .


Such patients , if treated with RT alone , had a higher loco-regional tumor failure rate as compared to the rest of the patients with known hypoxic status ( P = @ ) .


Although the trial was incomplete and suffered from a small number of patients , the results suggested an improvement in loco-regional tumor control and overall survival in patients with advanced HNSCC given the hypoxic modifier NIM in addition to accelerated fractionation RT. .


However , the trial also revealed that conducting multicenter and multinational study combining drug and RT in developing countries may suffer from uncontrolled and unsolvable problems .


Pain is highly prevalent among persons with HIV .


Alcohol may be used to `` self-medicate '' pain .


This study examined the association between pain and risky alcohol use over time in a cohort of HIV-infected Russian drinkers .


This secondary analysis utilized longitudinal data from a randomized trial of a behavioral intervention .


Subjects included HIV-infected adults who reported past @-month risky drinking and unprotected sex and were recruited from HIV and addiction treatment sites in St. Petersburg , Russia .


The main independent variable was pain that at least moderately interfered with daily living .


The primary outcome was past month risky drinking amounts based on NIAAA guidelines .


General estimating equations ( GEE ) logistic regression models were used to calculate odds ratios and @ % confidence intervals for the association between pain and risky drinking over time ( i.e. , baseline , @ and @ months ) , adjusting for potential confounders .


Baseline characteristics of participants ( n = @ ) were mean age of @ ( SD @ ) years , @ % female , and @ % < @th grade education .


Nearly one quarter ( @ % ) had a CD@ cell count < @ cells/l , and only @ % were on antiretroviral therapy .


Nearly half ( @ % ) reported at least moderate pain interference in the past month and @ % were drinking risky amounts .


In adjusted longitudinal GEE models , pain was significantly associated with greater odds of reporting past month risky drinking ( AOR = @ , @ % CI : @-@ @ , p value = @ ) .


Among a cohort of HIV-infected Russian drinkers , pain that at least moderately interfered with daily living was associated with higher odds of reporting risky drinking amounts over time .


Sideroblastic cardiomyopathy secondary to repeated blood transfusions is a feared complication in thalassaemia .


Control of myocardial iron is thus becoming the cornerstone of thalassaemia management .


Recent evidence suggests a role for L-type Ca ( @ + ) channels in mediating iron uptake by the heart .


Blocking the cellular iron uptake through these channels may add to the benefit of therapy to standard chelation in reducing myocardial iron .


We aim to determine the efficacy of amlodipine ( a calcium channel blocker ) as an adjunct to standard aggressive chelation in retarding myocardial iron deposition in thalassaemics with or without cardiomyopathy .


The primary outcome is to compare the efficacy of amlodipine + chelation ( intervention ) versus standard chelation ( control ) in retarding myocardial iron deposition .


Secondary outcomes include the effect of amlodipine therapy on systolic and diastolic function , strain and strain rate and liver iron content .


This is a single-centre , parallel-group , prospective randomised control trial .


Twenty patients will be randomised in a @:@ allocation ratio into the intervention and control arms .


In addition to conventional echocardiography , MRI T@ * values for assessment of cardiac and liver iron load will be obtained at baseline and at @ and @ months .


Cardiac T@ * will be reported as the geometric mean and per cent coefficient of variation , and an increase in cardiac T@ * values from baseline will be used as an end point to compare the efficacy of therapy .


A p Value of < @ will be considered significant .


Department of Pediatric and Child Health , Aga Khan University Hospital , Karachi , Pakistan .


The logistic European System for Cardiac Operative Risk Evaluation ( LES ) score and the Society of Thoracic Surgeons ( STS ) score are validated to predict @-day outcomes following surgical aortic valve replacement ( SAVR ) with or without coronary artery bypass grafting .


Their performance when applied to patients undergoing transcatheter aortic valve replacement ( TAVR ) is controversial .


We compared predicted and observed @-day/in-hospital and @-year mortality of patients undergoing TAVR in the first Placement of Aortic Transcatheter Valves trial and continued access registry ( N = @ ) .


The performance of the LES and STS scores ( prospectively calculated ) was evaluated using standard assessments of discrimination and calibration .


Performance of STS and LES scores among @ patients undergoing SAVR from the high-risk cohort of the randomized trial were also examined .


In patients undergoing TAVR , the observed @-day/in-hospital mortality was @ % , whereas the predicted @-day mortality was higher by both STS score ( @ % @ % ) and LES score ( @ % @ % ) .


The discrimination for both scores was poor for @-day/in-hospital and @-year mortality .


Calibration was better for STS score than for LES at @ year but poor for both at @ days among TAVR cohort .


These results were consistent among the subgroups of patients undergoing transfemoral and transapical access ; however , the STS score had better performance among the high-risk patients who underwent SAVR at @ days but not @ year .


The STS and LES surgical risk scores overestimated @-day/in-hospital mortality and were poor discriminators of post-TAVR mortality , but the calibration of the STS score was better in these high-risk patients .


These data highlight the need for TAVR-specific risk models to optimize patient selection .


Measures of health-related quality of life ( HRQL ) specific for sleep disorders have had limited psychometric evaluation in the context of randomized controlled trials ( RCTs ) .


We investigated the psychometric properties of the Functional Outcomes of Sleep Questionnaire ( FOSQ ) and Sleep Apnea Quality of Life Instrument ( SAQLI ) .


We evaluated the FOSQ and SAQLI construct and criterion validity , determined a minimally important difference , and assessed for associations of responsiveness to baseline subject characteristics and continuous positive airway pressure ( CPAP ) adherence in a RCT population .


Secondary analysis of data collected in a multisite RCT of home versus laboratory-based diagnosis and treatment of obstructive sleep apnea ( HomePAP trial ) .


Individuals enrolled in the HomePAP trial ( n = @ ) .


N/A .


The FOSQ and SAQLI subscores demonstrated high reliability and criterion validity , correlating with Medical Outcomes Study @-Item Short Form Survey domains .


Correlations were weaker with the Epworth Sleepiness Scale ( ESS ) .


Both the FOSQ and SAQLI scores improved after @ mo with CPAP therapy .


Averaging @ h or more of CPAP use was associated with an increase in the FOSQ beyond the minimally important difference .


Baseline depressive symptoms and sleepiness predicted FOSQ and SAQLI responsiveness ; demographic , objective obstructive sleep apnea ( OSA ) severity and sleep habits were not predictive in linear regression .


The FOSQ and SAQLI are responsive to CPAP intervention , with the FOSQ being more sensitive to differences in CPAP adherence than the SAQLI .


These instruments provide unique information about health outcomes beyond that provided by changes in physiological measures of OSA severity ( apnea-hypopnea index ) .


Children with epilepsy may have comorbidities that result in significant disability .


Epidemiological information for pediatric patients with epilepsy in Taiwan is scant .


This research estimates the prevalence and common neuro-psychiatric comorbidities of children with epilepsy in Taiwan .


Patients aged less than @ years old who had received a diagnosis of epilepsy and suffered from epileptic seizures in @ were identified in the NHIRD based on ICD-@-CM and prescription records for the use of at least one AED .


We used cases of epileptic seizure to survey outpatient service data , and identify common neuro-psychiatric comorbidities .


The crude prevalence rate and the age - and sex-specific prevalence were estimated .


We also examined the effects of urbanization .


The estimated prevalence of epilepsy was @ % in the pediatric population , with @ % for girls and @ % for boys .


The most common neuropsychiatric comorbidities were learning disability and developmental delay , cerebral palsy , and mental retardation .


Epilepsy was more prevalent in boys than in girls , especially among infants , preschool children , and those living in rural areas .


In addition , boys with epilepsy had a higher rate of neurological comorbidities .


The prevalence of psychiatric comorbidities was lower than that reported in previous studies performed in other countries , especially among children with epilepsy living in rural areas .


This research provides the largest nationwide , population-based study of childhood epilepsy to estimate the prevalence and the associated neuropsychiatric comorbidities of pediatric epilepsy in Taiwan .


Potential rural-urban disparity basing on prevalence and associated neuropsychiatric comorbidities can not be ignored in Taiwan .


While stimulation of the peripheral nerves increases the pain threshold , chronic pressure stimulation of the sciatic nerve is associated with sciatica .


We recently found that acute pressure block of the sciatic nerve inhibits pain .


Therefore , we propose that , the pain pathology-causing pressure is chronic , not acute .


Here , we report a novel self-administered method : acute pressure block of the sciatic nerves is applied by the patients themselves for short-term relief of pain from dental diseases .


This was a randomized , single-blind study .


Hospital patients .


Patients aged @-@ years with acute pulpitis , acute apical periodontitis , or pericoronitis of the third molar of the mandible experiencing pain @ on the @-point numerical pain rating scale .


Three-minute pressure to sciatic nerves was applied by using the hands ( hand pressure method ) or by having the patients squat to force the thigh and shin as tightly as possible on the sandwiched sciatic nerve bundles ( self-administered method ) .


The primary efficacy variable was the mean difference in pain scores from the baseline .


One hundred seventy-two dental patients were randomized .


The self-administered method produced significant relief from pain associated with dental diseases ( P@ @ ) .


The analgesic effect of the self-administered method was similar to that of the hand pressure method .


The self-administered method is easy to learn and can be applied at any time for pain relief .


We believe that patients will benefit from this method .


The aim of the study was to compare the sensory , motor , and neuroophthalmological effects of isobaric levobupivacaine and bupivacaine when intrathecally administered .


A prospective , double-blind , randomized study with @ ASA grade I-II patients aged @-@ years awaiting knee arthroscopy under spinal anesthesia .


Patients received @ mg of isobaric bupivacaine or levobupivacaine .


Several features were recorded .


No significant intergroup differences were observed for ASA classification , time to micturate , demographic data , surgery duration , and patient/surgeon satisfaction .


Similar hemodynamic parameters and sensory/motor blockade duration were found for both groups .


There were no neuroophthalmological effects in either group .


Sensory ( P = @ ) and motor blockade onset ( P = @ ) was faster in the bupivacaine group .


T@ ( T@-T@ ) and T@ ( T@-T@ ) were the highest sensory block levels for the levobupivacaine and bupivacaine groups , respectively ( P = @ ) .


It took less time to regain maximum motor blockade in the bupivacaine group ( P = @ ) , and the levobupivacaine group required use of analgesia earlier ( P = @ ) .


Isobaric bupivacaine and levobupivacaine are analogous and well-tolerated anesthetics for knee arthroscopy .


However , for bupivacaine , sensory and motor blockade onset was faster , and greater sensory blockade with a longer postoperative painless period was achieved .


Neurogenic orthostatic hypotension ( nOH ) is common in Parkinson 's disease ( PD ) , and represents a failure to generate norepinephrine responses appropriate for postural change .


Droxidopa ( L-threo-@ ,@ - dihydroxyphenylserine ) is an oral norepinephrine prodrug .


Interim analyses of the initial patients enrolled in a multicenter , randomized , double-blind , placebo-controlled phase @ trial of droxidopa for nOH in PD ( ClinicalTrials.gov Identifier : NCT@ ) .


PD patients with documented nOH underwent @ weeks of double-blind droxidopa or placebo dosage optimization followed by @ weeks of maintenance treatment ( @-@ mg t.i.d. ) .


The primary efficacy measure was change in Orthostatic Hypotension Questionnaire ( OHQ ) composite score from baseline to Week @ .


Key secondary variables included dizziness/lightheadedness score ( OHQ item @ ) and patient-reported falls .


Among @ droxidopa and @ placebo recipients , mean OHQ composite-score change at Week @ was -@ versus -@ ( p = @ ) ; in response to this pre-planned futility analysis , the study was temporarily stopped and all data from these patients were considered exploratory .


At Week @ , mean dizziness/lightheadedness score change favored droxidopa by @ units ( p = @ ) , with subsequent numerical differences favoring droxidopa throughout the observation period , and at Week @ , mean standing systolic blood-pressure change favored droxidopa by @ mmHg ( p = @ ) .


Compared with placebo , the droxidopa group exhibited an approximately @ % lower rate of reported falls ( p = @ ) and fall-related injuries ( post-hoc analysis ) .


This exploratory analysis of a small dataset failed to show benefit of droxidopa , as compared with placebo by the primary endpoint .


Nonetheless , there were signals of potential benefit for nOH , including improvement in dizziness/lightheadedness and reduction in falls , meriting evaluation in further trials .


The management of perioperative period for patients with spontaneous intracerebral hemorrhage affects the prognosis .


Elevated blood pressure is common in the patients with spontaneous intracerebral hemorrhage and related to a poor outcome .


However , study on antihypertensive treatment for surgical patients with spontaneous intracerebral hemorrhage is insufficient .


To determine if the intensive antihypertensive treatment improves the prognosis compared with the conservative antihypertensive treatment followed guidelines in perioperative period for patients with spontaneous intracerebral hemorrhage .


PATICH is a prospective , parallel , randomized , assessor-blinded trial .


Two hundred eligible patients will be assigned to the intensive group and conservative group randomly .


Patients allocated to the intensive group will receive an intensive antihypertensive treatment aiming to achieve a target systolic blood pressure of between @ mmHg and @ mmHg while the patients in the conservative group will receive conservative antihypertensive treatment as recommended by guidelines for @ days .


Operation will be conducted by well-trained surgeons and the best medical treatment will be given in all patients .


Patients will be followed up at @ days , @ days , and @ days .


Primary outcome of this study is the rate of rehemorrhage in @ days after surgery .


Secondary outcomes include death and dependency at @ days incidence of ischemic stroke , separate rate of death and dependency at @ days , health related quality of life ( HRQoL ) at @ days , incidence of other vascular events , and days of hospitalization .


Dependency is defined by a score of @-@ based on the modified Rankin Scale ( mRS ) .


To compare the effect that initiating different antiretroviral therapy ( ART ) regimens has on weight , BMI , and lean body mass ( LBM ) and explore how changes in body composition are associated with bone mineral density ( BMD ) .


A@s was a sub-study of A@ , a prospective trial of @ ART-naive participants randomized to blinded abacavir-lamivudine ( ABC/@TC ) or tenofovir DF-emtricitabine ( TDF/FTC ) with open-label efavirenz ( EFV ) or atazanavir-ritonavir ( ATV/r ) .


All participants underwent dual-energy absorptiometry ( DXA ) and abdominal computed tomography for body composition .


Analyses used two-sample t-tests and linear regression .


A@s included @ participants : @ % men , @ % white non-Hispanic , median age @ years , HIV-@ RNA @ log@ copies/ml , and CD@ cell count @ cells/l .


Overall , significant gains occurred in weight , BMI , and LBM at @ weeks post-randomization ( all P < @ ) .


Assignment to ATV/r ( vs. EFV ) resulted in significantly greater weight ( mean difference @ kg ) and BMI gain ( @ kg/m ; both P = @ ) , but not LBM ( @ kg ; P = @ ) , whereas ABC/@TC and TDF/FTC were not significantly different ( P@ @ ) .


In multivariable analysis , only lower baseline CD@ cell count and higher HIV-@ RNA were associated with greater increase in weight , BMI , or LBM .


In multivariable analyses , increased LBM was associated with an increased hip BMD .


ABC/@TC vs. TDF/FTC did not differ in change in weight , BMI , or LBM ; ATV/r vs. EFV resulted in greater weight and BMI gain but not LBM .


A positive association between increased LBM and increased hip BMD should be further investigated through prospective interventional studies to verify the impact of increased LBM on hip BMD .


Preservation of renal function is prioritized during surgical management of localized renal cell carcinoma .


VEGF targeted agents can downsize tumors in metastatic renal cell carcinoma and may do the same in localized renal cell carcinoma , allowing for optimal preservation of renal parenchyma associated with partial nephrectomy .


Localized clear cell renal cell carcinoma patients meeting @ or both of the following criteria were enrolled in a prospective phase II trial , including radical or partial nephrectomy likely to yield a glomerular filtration rate of less than @ ml/minute/@ @ m ( @ ) , or partial nephrectomy high risk due to high complexity ( R.E.N.A.L. @ to @ ) or tumor adjacent to hilar vessels .


Pazopanib ( @ mg once daily ) was administered for @ to @ weeks with repeat imaging at completion of therapy , followed by surgery .


A total of @ patients enrolled with a median tumor size of @ cm and a median R.E.N.A.L. score of @ .


Of index lesions @ % were high complexity and @ % of patients had a solitary kidney .


Patients received a median of @ weeks of pazopanib .


The median interval from treatment start to surgery was @ weeks .


R.E.N.A.L. score decreased in @ % of tumors and @ % of patients experienced a reduction in tumor volume .


Six of @ patients for whom partial nephrectomy was not possible at baseline were able to undergo partial nephrectomy after treatment .


The mean parenchymal volume that could be saved with surgery increased from an estimated @ to @ cc ( p = @ ) .


In @ patients a urine leak developed , which was managed conservatively , and @ received a transfusion , of whom @ required embolization .


Neoadjuvant pazopanib resulted in downsizing localized renal cell carcinoma , allowing for improved preservation of renal parenchyma and enabling partial nephrectomy in a select subset of patients who would otherwise require radical nephrectomy .


To evaluate the influence of attenuation-based tube potential selection ( ATPS ) in combination with organ-specific dose reduction ( OSDR ) on radiation dose and image quality of contrast-enhanced chest computed tomography ( CT ) examinations .


Seventy consecutive patients ( @ years ; @ men ; @ women ) were randomized into two groups and underwent contrast-enhanced chest CT using a @ section CT scanner .


CT examinations were performed as standard protocol in group A ( n = @ ) and with the activated novel dose-saving devices , OSDR and ATPS , in group B ( n = @ ) .


Objective -LSB- signal-to-noise ( SNR ) and contrast-to-noise ratio ( CNR ) -RSB- and subjective image quality ( five-point scale ; @ = non diagnostic ; @ = excellent ) as well as radiation dose ( CTDIvol ) were analysed .


CTDIvol of the protocol using OSDR and ATPS was significantly lower than in standard chest CT examinations ( @ versus @ mGy ; p < @ ) .


Although the level of noise was slightly elevated in group B ( @ versus @ HU ; p < @ ) , no significant differences in SNR ( @ versus @ ) or subjective image quality ( mean score of @ versus @ ) were observed between both imaging protocols .


Attenuation-based tube potential selection in combination with organ-specific dose reduction essentially reduces the dose of chest CT in patients with normal body mass index ( BMI ) in clinical routine while maintaining subjective and objective image quality .


To compare the therapeutic effects of metformin ( Met ) and laparoscopic ovarian drilling ( LOD ) in clomiphene and insulin-resistant patients with polycystic ovary syndrome ( CIRPCOS ) .


A total of @ patients were randomly divided into two groups .


One group was administered Met ( n = @ ) , while the other group underwent LOD ( n = @ ) .


Rates of ovulation , pregnancy , and abortion were compared between both groups .


Rates of normal menstruation , ovulation , and pregnancy in the LOD group were higher than in the Met group : @ % ( @/@ ) vs. @ % ( @/@ ) , P < @ ; @ % ( @/@ ) vs. @ % ( @/@ ) , P < @ ; @ % ( @/@ ) vs. @ % ( @/@ ) , P < @ .


The difference in the early abortion rate between both groups was not statistically significant .


Although Met can significantly improve a patient 's insulin resistance , we found that in patients diagnosed with CIRCPOS , LOD can be much more effective in improving rates of normal menstruation , ovulation , and pregnancy .


To compare self-reported pedometer steps with accelerometer steps under free-living conditions in individuals with Parkinson 's disease ( PD ) or osteoporosis ( OP ) .


Seventy-three individuals with PD and @ individuals with OP wore a pedometer ( Yamax LS@ ) and an accelerometer ( ActiGraph GT@M/GT@X + ) simultaneously for one week .


Fifty-one individuals with PD ( @ @ years ) and @ with OP ( @ @ years ) provided simultaneously recorded data for @-@ consecutive days .


Pedometer steps were significantly lower than accelerometer steps in the PD group ( p = @ ) but not in the OP group ( p = @ ) .


Bland-Altman plots demonstrated wide limits of agreement between the instruments in both PD ( range = @,@ steps ) and OP ( range = @,@ steps ) .


These results suggest that the ActiGraph GT@M/GT@X + should be preferred over the Yamax LS@ for the assessment of steps in both research and clinical evaluations , particularly in individuals with PD or altered gait .


It is not uncommon for patients with ischemic stroke to have peripheral arterial disease ( PAD ) .


Patients with polyvascular diseases carry greater burden of atherosclerosis and higher risks of developing vascular events and death .


More effective regimens , such as dual antiplatelet agents , may be more effective for controlling progression of atherosclerosis in secondary prevention .


This study aims to evaluate whether cilostazol plus aspirin is more efficacious than aspirin alone for preventing progression of atherosclerosis in patients with ischemic stroke or transient ischemic attack ( TIA ) who also have peripheral arterial disease .


The Safety and Efficacy of Cilostazol in Ischemic Stroke Patients with Peripheral Arterial Disease ( SPAD ) study is a randomized double-blinded placebo-controlled trial .


Patients with previous ischemic stroke or TIA who had been taking aspirin ( @mg per day ) , aged @ years or older , with PAD in the lower limbs based on ankle-brachial index ( ABI ) < @ will be randomized into the treatment group with cilostazol ( @mg/day ) or the placebo group on @:@ basis .


Patients will be evaluated at @ , @ , @ , @ and @ months after randomization .


The primary endpoint is difference in change in ABI between groups .


The secondary and tertiary endpoints are the difference between groups in change in carotid intima-media thickness ( IMT ) and incidence rate of major cardiovascular events , including recurrent stroke , myocardial infarction , unstable angina , other vascular events , and death ; and the safety measures , including major bleeding events , hemorrhagic stroke and death of any cause .


The SPAD trial is the first study to evaluate the safety and efficacy of dual antiplatelet agents , aspirin plus cilostazol , in comparison with aspirin alone in patients with both ischemic stroke or TIA and PAD .


Results from this trial will provide important information on the merit of adding cilostazol to aspirin for slowing down progression of atherosclerosis in patients with ischemic stroke and PAD .


Maraviroc , a chemokine co-receptor type @ ( CCR@ ) antagonist , has demonstrated comparable efficacy and safety to efavirenz , each in combination with zidovudine/lamivudine , over @ weeks in the Maraviroc vs. Efavirenz Regimens as Initial Therapy ( MERIT ) study .


Here we report @-year findings .


A randomized , double-blind , multicenter phase IIb/III study with an open-label extension phase .


Treatment-naive patients with CCR@-tropic HIV-@ infection ( Trofile ) received maraviroc @ mg twice daily or efavirenz @ mg once daily , and zidovudine/lamivudine @ mg/@ mg twice daily .


After the last patient 's week @ visit , the study was unblinded and patients could enter a nominal @-year open-label phase .


Endpoints at the @-year nominal visit ( week @ ) included proportion of patients ( CCR@ tropism re-confirmed by enhanced sensitivity Trofile ) with viral load ( plasma HIV-@ RNA ) below @ and @ copies/ml , and change from baseline in CD@ ( + ) cell count , as well as safety .


The proportion of patients maintaining viral load below @ copies/ml was similar between treatment arms throughout the study and at week @ ( maraviroc @ % vs. efavirenz @ % ) .


Maraviroc-treated patients had a greater increase from baseline in mean CD@ ( + ) cell count than efavirenz-treated patients at week @ ( @ vs. @ cells/l , respectively ) .


Fewer patients on maraviroc vs. efavirenz experienced treatment-related adverse events ( @ vs. @ % ) and discontinued as a result of any adverse event ( @ vs. @ % ) .


Maraviroc maintained similar long-term antiviral efficacy to efavirenz over @ years in treatment-naive patients with CCR@-tropic HIV-@ .


Maraviroc was generally well tolerated with no unexpected safety findings or evidence of long-term safety concerns .


Management of contaminated patients in the decontamination corridor requires the use of hazardous material ( HazMat ) personal protective equipment ( PPE ) .


Previous studies have demonstrated that HazMat PPE may increase the difficulty of airway management .


This study compared the efficiency of video laryngoscopy ( VL ) with traditional direct laryngoscopy ( DL ) during endotracheal intubation ( ETI ) while wearing HazMat PPE .


Post-graduate year ( PGY ) @-@ Emergency Medicine residents were randomized to VL or DL while wearing encapsulating PPE .


Video laryngoscopy was performed using the GlideScope Cobalt AVL video laryngoscope .


The primary outcome measure was time to successful ETI in a high-fidelity simulation mannequin .


Three time points were utilized in the analysis : Time @ ( blade at lips ) , Time @ ( blade removed from lips after endotracheal tube placement ) , and Time @ ( bag valve mask -LSB- BVM -RSB- attached to endotracheal tube ) .


Secondary outcome measures were perceived ease of use and feasibility of VL and DL ETI modalities .


Twenty-one of @ ( @ % ) eligible residents participated .


Mean time to ETI was @ seconds ( SD = @ seconds ) in the DL group and @ seconds ( SD = @ seconds ) in the VL group ( P = @ ) .


Mean times from blade insertion until BVM attachment were @ seconds ( SD = @ seconds ) and @ seconds ( SD = @ seconds ) , respectively ( P = @ ) .


There were no unsuccessful intubation attempts .


Seventeen out of @ participants ( @ % ) perceived VL to be easier to use when performing ETI in PPE .


Twelve out of @ participants ( @ % ) perceived DL to be more feasible in an actual HazMat scenario .


The time to successful ETI was not significantly different between VL and DL .


Video laryngoscopy had a greater perceived ease of use , but DL was perceived to be more feasible for use in actual HazMat situations .


These findings suggest that both DL and VL are reasonable modalities for use in HazMat situations , and the choice of modality could be based on the clinical situation and provider experience .


Although quantitative right ventricular ( RV ) strain analysis may be useful in congenital and acquired heart disease populations with RV failure , a comprehensive , standardized approach is lacking .


An @-segment RV strain analysis obtained from three standardized RV apical echocardiographic images was used to determine the feasibility , normal values , and reproducibility of the method in normal adults .


Forty healthy , prospectively enrolled volunteers with no cardiac histories and normal QRS durations underwent echocardiography optimized for strain analysis including three RV apical views .


Two-dimensional speckle-tracking longitudinal strain analysis was performed using EchoPAC software .


Eleven retrospectively identified subjects with RV disease were included as a pilot population .


All had been imaged using the same protocol including the three RV apical views .


All control subjects had normal anatomic morphology and function by echocardiography .


Feasibility of the RV strain analysis was good ( adequate tracking in @ of @ segments -LSB- @ % -RSB- ) .


RV global peak systolic strain was -@ @ % .


Peak strain was highest in the RV free wall and lowest in the septum .


Dyssynchrony indices demonstrated no dyssynchrony using left ventricular criteria .


Reproducibility of most strain measures was acceptable .


This methodology identified important disease not seen in the four-chamber apical view alone in the pilot population of @ patients with RV disease .


Strain patterns and values were different from those in the control population , indicating that differences do exist from normal .


Eighteen-segment RV strain analysis is feasible , with strain measures falling into discrete ranges in this normal population .


Those with RV disease illustrate the potential utility of this approach .


These data indicate that this model can be used for more detailed studies evaluating abnormal RV populations , in which its full potential can be assessed .


Hypovitaminosis D is particularly common among older people with a proximal femoral ( hip ) fracture .


There are currently no agreed strategies for vitamin D replenishment after hip fracture surgery .


The REVITAHIP Study is a multisite , double-blinded randomized-controlled trial investigating the effects of an oral vitamin D loading dose on gaitvelocity after hip fracture surgery .


We describe the baseline characteristics of participants , aiming to document hypovitaminosis D and its associations after hip fracture .


Participants , over @ , recruited within @ days following hip fracture surgery from @ Australia hospitals , were randomly allocated to receive a loading dose of vitamin D@ ( @,@ IU ) or placebo , followed by oral maintenance vitamin D@/calcium ( @ IU/@ mg ) and the usual hip fracture rehabilitation pathway.Demographic and clinical data were collected , including surgical procedure , pre-fracture functional status , Mini Mental State Examination ( MMSE ) score , serum @-hydroxyvitamin D ( @-OHD ) , Verbal Rating Scale ( VRS ) for pain , grip strength and gait velocity .


The associations of baseline @-OHD levels with demographic and clinical data were assessed using Pearson 's correlation , ANOVA and regression analyses .


Two-hundred-and-eighteen people with hip fracture participated in the study .


Mean age was @ + / -@ years , @ % were women and @ % lived in privatehomes .


Fifty-six percent had a subcapital fracture .


Mean comorbidity count was @ + / -@ .


Mean MMSE was @ + / -@ .


Forty-seven percent of participants had hypovitaminosis D ( < @ nmol/L ) .


Multivariate regression models demonstrated higher baseline vitamin D levels were significantly associated with higher premorbid Barthel index scores , lower post-operative VRS pain levels and use of vitamin D.


This study cohort shared similar demographic characteristics and comorbidities with other cohorts of people with hip fracture , with the probable exception of less cognitive impairment .


Hypovitaminosis D was not as prevalent as previously documented .


Patients taking vitamin D supplements and with higher premorbid Barthel index , reflecting greater independence and activity , tended to have higher @-OHD levels at baseline .


Further , lower VRS pain ratings following surgery were associated with higher vitamin D levels .


Such associations will need further investigation to determine causation .


( ANZCTR number , ACTRN@ ) .


To evaluate the effectiveness of a desensitizing gel for topical and home use for the treatment of dentin hypersensitivity ( DH ) by means of a @-arm parallel , randomized , double blind clinical trial .


@ participants were allocated to three groups : placebo gel ( PG ) , test gel ( TG ) ( @ % sodium fluoride , @ % potassium oxalate , @ % strontium chloride ) and @ % sodium fluoride gel ( FG ) .


DH measurement was performed by a single blind examiner by means of the visual analog scale ( VAS ) after tactile ( blunt tipped probe ) , thermal ( air blast ) and osmotic ( water blast ) stimulus at time intervals of baseline , @ , @ and @ days .


The greatest reductions in DH were observed for the TG , with significant differences for FG in the thermal ( = -@ vs -@ ) and osmotic stimuli ( = -@ vs -@ ) .


Considering the percentage of participants with moderate/severe pain at @ days , the TG demonstrated the lowest percentages , with significant differences in comparison with the other groups in thermal and osmotic stimuli .


We can conclude that the test gel showed a greater reduction in DH than fluoride @ % and placebo gel , and maybe a treatment option for individuals with DH .


Morbidly obese patients are at high risk for perioperative complications , including surgical site infections .


Baseline arterial oxygenation is low in the morbidly obese , leading to low tissue oxygenation , which in turn is a primary determinant of infection risk .


We therefore tested the hypothesis that extending intraoperative supplemental oxygen @ to @ hours into the postoperative period reduces the risk of surgical site infection and healing-related complications .


Morbidly obese patients having open or laparoscopic bariatric surgery were given @ % inspired oxygen intraoperatively .


Postoperatively , patients were randomly assigned to either @ L/min of oxygen via nasal cannula or approximately @ % supplemental inspired oxygen after tracheal extubation until the first postoperative morning .


The risks of surgical site infection and of major healing-related complications were evaluated @ days after surgery .


In a preplanned interim analysis based on the initial @ patients , the overall observed incidence of the collapsed composite of major complications was @ % ; the observed incidence of components of the composite outcome ranged from @ % ( peritonitis ) to @ % ( surgical wound infection ) .


The estimated relative risk of any @ major complications occurring within the first @ days after surgery , adjusting for study site , was @ ( @ % confidence interval , @-@ @ ) ( P = @ , Cochran-Mantel-Haenszel ) .


The Executive Committee thus stopped the trial for futility .


Supplemental postoperative oxygen does not reduce the risk of surgical site infection rate and healing-related postoperative complications in patients having gastric bypass surgery .


To assess whether endotracheal suctioning of nonvigorous infants born through meconium stained amniotic fluid ( MSAF ) reduces the risk and complications of meconium aspiration syndrome ( MAS ) .


Term , nonvigorous babies born through MSAF were randomized to endotracheal suction and no-suction groups ( n = @ in each ) .


Risk of MAS , complications of MAS and endotracheal suction , mortality , duration of neonatal intensive care unit stay , and neurodevelopmental outcome at @ months were assessed .


Maternal age , consistency of meconium , mode of delivery , birth weight , sex , and Apgar scores were similar in the groups .


In total , @ ( @ % ) neonates developed MAS and @ ( @ % ) of them died .


There were no significant differences in MAS , its severity and complications , mortality , and neurodevelopmental outcome for the @ groups .


One infant had a complication of endotracheal suctioning , which was mild and transient .


The current practice of routine endotracheal suctioning for nonvigorous neonates born through MSAF should be further evaluated .


This phase @ trial compared the safety and efficacy of edoxaban , an oral direct factor Xa inhibitor , with enoxaparin sodium ( enoxaparin ) for thromboprophylaxis after total knee arthroplasty ( TKA ) in patients in Japan and Taiwan .


In this randomized , double-blind , double-dummy study , patients received oral edoxaban @ mg once daily beginning @ to @ hours postsurgery or enoxaparin @ IU ( equivalent to @ mg ) subcutaneously twice daily beginning @ to @ hours postsurgery for @ to @ days .


The primary efficacy endpoint was the composite of symptomatic pulmonary embolism and symptomatic and asymptomatic deep vein thrombosis .


Safety endpoints included the incidence of major bleeding , clinically relevant non-major ( CRNM ) bleeding , major bleeding or CRNM bleeding , all bleeding events , adverse events , and adverse drug reactions .


Of @ patients enrolled , @ and @ were randomized to receive edoxaban or enoxaparin , respectively .


The primary efficacy outcome occurred in @/@ ( @ % ) and @/@ ( @ % ) patients in the edoxaban and enoxaparin groups , respectively ( relative risk reduction = @ % ) , indicating non-inferiority ( P < @ ) and superiority ( P = @ ) of edoxaban versus enoxaparin .


In the edoxaban and enoxaparin groups , major bleeding occurred in @/@ ( @ % ) versus @/@ ( @ % ) patients ( P = @ ) ; major or CRNM bleeding occurred in @/@ ( @ % ) versus @/@ ( @ % ) patients ( P = @ ) , respectively .


Edoxaban @ mg once daily was more effective for thromboprophylaxis than subcutaneous enoxaparin @ IU twice daily following TKA and demonstrated a similar incidence of bleeding events .


Some chronic pain patients receiving long-term opioid analgesic pharmacotherapy are at risk for misusing opioids .


Like other addictive behaviors , risk of opioid misuse may be signaled by an attentional bias ( AB ) towards drug-related cues .


The purpose of this study was to examine opioid AB as a potential predictor of opioid misuse among chronic pain patients following behavioral treatment .


Chronic pain patients taking long-term opioid analgesics ( n = @ ) completed a dot probe task designed to assess opioid AB , as well as self-report measures of opioid misuse and pain severity , and then participated in behavioral treatment .


Regression analyses examined opioid AB and cue-elicited craving as predictors of opioid misuse at @-month posttreatment follow-up .


Patients who scored high on a measure of opioid misuse risk following treatment exhibited significantly greater opioid AB scores than patients at low risk for opioid misuse .


Opioid AB for @ ms cues and cue-elicited craving significantly predicted opioid misuse risk @ weeks later , even after controlling for pre-treatment opioid dependence diagnosis , opioid misuse , and pain severity ( Model R ( @ ) = @ ) .


Biased initial attentional orienting to prescription opioid cues and cue-elicited craving may reliably signal future opioid misuse risk following treatment .


These measures may therefore provide potential prognostic indicators of treatment outcome .


This analysis assessed changes in serum @-hydroxyvitamin D ( @ -LSB- OH -RSB- D ; the precursor form of active vitamin D ) in antiretroviral-naive adults receiving rilpivirine or efavirenz over @ weeks in a randomized , double-blind , Phase III trial ( ECHO ) .


ECHO included @ patients randomized @:@ to receive rilpivirine @ mg once daily ( n = @ ) or efavirenz @ mg once daily ( n = @ ) , plus tenofovir disoproxil fumarate/emtricitabine .


@ ( OH ) D was measured in stored serum samples collected at baseline , and weeks @ and @ .


Proportions of patients with optimal/sufficient ( @ ng/ml ) , insufficient ( @-@ ng/ml ) , deficient ( @-@ ng/ml ) and severely deficient ( < @ ng/ml ) @ ( OH ) D levels were determined .


Data are presented for patients with paired baseline and week @ @ ( OH ) D data ( rilpivirine , n = @ ; efavirenz , n = @ ) .


After @ weeks , mean @ ( OH ) D levels remained largely unchanged from baseline with rilpivirine ( -@ ng/ml ; P = @ versus no change ) , but were significantly reduced with efavirenz ( -@ ng/ml ; P < @ versus no change ) .


When adjusting for season of randomization and the combined variable of race ( Black/African American , White/Caucasian , Asian , other race ) and ethnicity ( Hispanic or Latino and not Hispanic or not Latino ) , the conclusion about the treatment difference between the rilpivirine and efavirenz treatment groups remained valid .


At baseline the proportion of patients with severe @ ( OH ) D deficiency was similar in both groups ( @ % ) but was significantly lower with rilpivirine than efavirenz at week @ ( @ % versus @ % , respectively ; P = @ ) .


Furthermore , of the patients with @ ( OH ) D insufficiency/deficiency at baseline , the proportion who developed severe @ ( OH ) D deficiency at week @ was significantly lower with rilpivirine than efavirenz ( @ % versus @ % , respectively ; P = @ ) .


Rilpivirine had little effect on @ ( OH ) D , whereas efavirenz resulted in a significant reduction in @ ( OH ) D levels and an increase in the risk of severe @ ( OH ) D deficiency .


This study aimed to investigate the effects of a @-month preventive resistance training program on resting metabolic rate ( RMR ) and its associations with fat-free mass ( FFM ) and the newly described myokine irisin as two potential mechanistic links between exercise training and RMR .


In a randomized controlled trial , @ sedentary healthy male and female participants either completed @ months of high-repetition resistance training @ dwk in accordance with the American College of Sports Medicine recommendations ( RT : n = @ ; @ @ yr ; body mass index , @ @ kgm ) or served as controls ( CO : n = @ ; @ @ yr ; body mass index , @ @ kgm ) .


Strength ( one-repetition maximum ) , RMR ( indirect calorimetry ) , body fat ( caliper method ) , and serum irisin concentration ( enzyme-linked immunosorbent assay ) were measured before and after @ months of training .


Training led to an increase in strength ( one-repetition maximum leg press , @ % @ % ; P < @ ) .


RMR increased in RT ( @ @ vs @ @ kcald , P < @ ) but not in CO ( @ @ vs @ @ kcald , P = @ ; group-time interaction , P < @ ) .


Body weight ( RT , -@ @ kg ; CO , @ @ kg ) , body fat percentage ( RT , -@ % @ % ; CO , -@ % @ % ) , and FFM ( RT , @ @ kg ; CO , @ @ kg ) did not develop differently between groups ( group-time interaction : P = @ , P = @ , and P = @ , respectively ) .


Serum irisin concentration increased in CO ( @ @ ngmL , P < @ ) but not in RT ( @ @ ngmL , P = @ ; group-time interaction , P < @ ) .


The change in RMR was not associated with the change in FFM ( r = -@ , P = @ ) or irisin ( r = -@ , P = @ ) .


Preventive resistance training elicits an increase in RMR .


However , in contrast to currently discussed hypotheses , this increase does not seem to be mediated by training-induced changes in FFM or circulating irisin concentration , which casts doubt in the meaning of irisin for human energy balance .


Despite rapid dissemination of an everolimus-eluting bioresorbable scaffold for treatment for coronary artery disease , no data from comparisons with its metallic stent counterpart are available .


In a randomised controlled trial we aimed to compare an everolimus-eluting bioresorbable scaffold with an everolimus-eluting metallic stent .


Here we report secondary clinical and procedural outcomes after @ year of follow-up .


In a single-blind , multicentre , randomised trial , we enrolled eligible patients aged @-@ years with evidence of myocardial ischaemia and one or two de-novo native lesions in different epicardial vessels .


We randomly assigned patients in a @:@ ratio to receive treatment with an everolimus-eluting bioresorbable scaffold ( Absorb , Abbott Vascular , Santa Clara , CA , USA ) or treatment with an everolimus-eluting metallic stent ( Xience , Abbott Vascular , Santa Clara , CA , USA ) .


Randomisation was stratified by diabetes status and number of planned target lesions .


The co-primary endpoints of this study are vasomotion ( change in mean lumen diameter before and after nitrate administration at @ years ) and difference between minimum lumen diameter ( after nitrate administration ) after the index procedure and at @ years .


Secondary endpoints were procedural performance assessed by quantitative angiography and intravascular ultrasound ; composite clinical endpoints based on death , myocardial infarction , and coronary revascularisation ; device and procedural success ; and angina status assessed by the Seattle Angina Questionnaire and exercise testing at @ and @ months .


Cumulative angina rate based on adverse event reporting was analysed post hoc .


This trial is registered at ClinicalTrials.gov , number NCT@ .


Between Nov @ , @ , and June @ , @ , we enrolled @ patients and randomly assigned them to the bioresorbable scaffold group ( @ patients , @ lesions ) or the metallic stent group ( @ patients , @ lesions ) .


Dilatation pressure and balloon diameter at the highest pressure during implantation or postdilatation were higher and larger in the metallic stent group , whereas the acute recoil post implantation was similar ( @ mm for both , p = @ ) .


Acute lumen gain was lower for the bioresorbable scaffold by quantitative coronary angiography ( @ mm vs @ mm , p < @ ) and quantitative intravascular ultrasound ( @ mm ( @ ) vs @ mm ( @ ) , p < @ ) , resulting in a smaller lumen diameter or area post procedure .


At @ year , however , cumulative rates of first new or worsening angina from adverse event reporting were lower ( @ patients -LSB- @ % -RSB- in the bioresorbable scaffold group vs @ -LSB- @ % -RSB- in the metallic stent group , p = @ ) , whereas performance during maximum exercise and angina status by SAQ were similar .


The @-year composite device orientated endpoint was similar between the bioresorbable scaffold and metallic stent groups ( @ patients -LSB- @ % -RSB- vs five patients -LSB- @ % -RSB- , p = @ ) .


Three patients in the bioresorbable scaffold group had definite or probable scaffold thromboses ( one definite acute , one definite sub-acute , and one probable late ) , compared with no patients in the metallic stent group .


There were @ ( @ % ) major cardiac adverse events in the bioresorbable scaffold group compared with five ( @ % ) events in the metallic stent group , with the most common adverse events being myocardial infarction ( @ cases -LSB- @ % -RSB- vs two cases -LSB- @ % -RSB- , respectively ) and clinically indicated target-lesion revascularisation ( four cases -LSB- @ % -RSB- vs three cases -LSB- @ % -RSB- , respectively ) .


The everolimus-eluting bioresorbable scaffold showed similar @-year composite secondary clinical outcomes to the everolimus-eluting metallic stent .


Although sleep has been shown to enhance motor skill learning , it remains unclear whether sleep enhances learning of a functional motor task in middle-aged and older individuals .


The purpose of this study was to examine whether sleep enhances motor learning of a functional motor task in middle-aged and older adults .


Twenty middle-aged and @ older individuals were randomly assigned to either the sleep condition or the no-sleep condition .


Participants in the sleep condition practiced a novel walking task in the evening , and returned the following morning for retesting .


Participants in the no-sleep condition practiced the walking task in the morning and returned the same day in the evening for a retest .


Outcome measures included time around the walking path and spatiotemporal gait parameters .


Only the middle-aged and older adults in the sleep condition demonstrated significant off-line improvement in performance , measured as a decline in time to walk around the novel path and improvement in spatiotemporal gait parameters .


The middle-aged and older adults in the no-sleep condition failed to demonstrate off-line improvements in performance of this functional task .


This is the first study to provide evidence that sleep facilitates learning a clinically relevant functional motor task in middle-aged and older adults .


Because many neurologic conditions occur in the middle-aged and older adults and sleep issues are very prevalent in many neurologic conditions , it is imperative that physical therapists consider sleep as a factor that may impact motor learning and recovery in these individuals .


The presence of an adequate zone of keratinized tissue has been associated with implant health .


This study evaluated the increasing of the zone of keratinized tissue using dense polytetrafluoroethylene ( d-PTFE ) membranes over extraction sites , without primary closure .


Fifteen sites received d-PTFE membranes .


The control sites received no membranes .


All cases were sutured with no attempt to achieve primary closure .


Before surgery , initial measurements of buccal and lingual keratinized tissue were taken from the mucogingival line ( MGL ) to the most coronal gingival margins .


Final measurements were taken from the buccal MGL to the lingual MGL , @ and @ days after extractions .


In the test group , a mean increase in the zone of keratinized tissue of @ @ mm and @ @ mm was observed in @ and @ days , respectively .


In the control group , a mean increase of @ @ mm and @ @ mm was observed in @ and @ days , respectively .


Nonexpanded d-PTFE membranes can predictably be used to increase the zone of keratinized tissue in preparation to implant placement .


To investigate the impact of tuberculosis-associated immune reconstitution inflammatory syndrome ( TB-IRIS ) upon immunological recovery and the T-cell compartment after initiation of TB and antiretroviral therapy ( ART ) .


We prospectively evaluated T-cell immunophenotypes by flow cytometry and cytokines by Luminex assays in a subset ( n = @ ) of highly immunosuppressed HIV-infected patients with TB from the Cambodian Early versus Late Introduction of Antiretrovirals randomized clinical trial .


We compared findings from patients who developed TB-IRIS with findings from patients who did not develop TB-IRIS .


Data were evaluated with mixed-effect linear regression , Kaplan-Meier estimates , and Wilcoxon rank-sum tests , and q-values were calculated to control for multiple comparisons .


Development of TB-IRIS was associated with significantly greater pre-ART frequencies of HLA-DRCD@ROCD@ , CCR@CD@ , OX@CD@ , and Fas effector memory CD@ T cells , and significantly elevated levels of plasma interleukin ( IL ) -@ , IL-@ , IL-@ , and IL-@ , and viral load .


Post-ART initiation , effector memory CD@ and Fas effector memory CD@ T-cell frequencies significantly expanded , and central memory CD@ T-cell frequencies significantly contracted in patients who experienced TB-IRIS .


By week @ post-TB treatment initiation , effector memory/central memory CD@ T-cell ratios were markedly higher in TB-IRIS versus non-TB-IRIS patients .


A distinct pattern of pre-ART T-cell and cytokine markers appear to poise the immune response of certain patients to develop TB-IRIS .


Experience of TB-IRIS is then associated with long-term remodeling of the CD@ T-cell memory compartment towards an effector memory-dominated phenotype .


We speculate that these pre and post-ART TB-IRIS-associated immune parameters may contribute to superior immune control of TB/HIV co-infection and better clinical outcome .


Frequent handwashing can prevent infections , but non-compliance to hand hygiene is pervasive .


Few theory - and evidence-based interventions to improve regular handwashing are available .


Therefore , two intervention modules , a motivational and a self-regulatory one , were designed and evaluated .


In a longitudinal study , @ young adults , aged @ to @ years , were randomized into two intervention groups .


The Mot-SelfR group received first a motivational intervention ( Mot ; risk perception and outcome expectancies ) followed by a self-regulatory intervention ( SelfR ; perceived self-efficacy and planning ) @ days later .


The SelfR-Mot group received the same two intervention modules in the opposite order .


Follow-up data were assessed @ and @ days after the baseline .


Both intervention sequences led to an increase in handwashing frequency , intention , self-efficacy , and planning .


Also , overall gains were found for the self-regulatory module ( increased planning and self-efficacy levels ) and the motivational module ( intention ) .


Within groups , the self-regulatory module appeared to be more effective than the motivational module , independent of sequence .


Self-regulatory interventions can help individuals to exhibit more handwashing .


Sequencing may be important as a motivation module ( Mot ) first helps to set the goal and a self-regulatory module ( SelfR ) then helps to translate this goal into actual behavior , but further research is needed to evaluate mechanisms .


The primary goal of Phase II clinical trials is to understand better a treatment 's safety and efficacy to inform a Phase III go/no-go decision .


Many Phase II designs have been proposed , incorporating randomization , interim analyses , adaptation , and patient selection .


The Phase II design with an option for direct assignment ( i.e. stop randomization and assign all patients to the experimental arm based on a single interim analysis ( IA ) at @ % accrual ) was recently proposed -LSB- An et al. , @ -RSB- .


We discuss this design in the context of existing designs , and extend it from a single-IA to a two-IA design .


We compared the statistical properties and clinical relevance of the direct assignment design with two IA ( DAD-@ ) versus a balanced randomized design with two IA ( BRD-@ ) and a direct assignment design with one IA ( DAD-@ ) , over a range of response rate ratios ( @-@ @ ) .


The DAD-@ has minimal loss in power ( < @ % ) and minimal increase in T@ER ( < @ % ) compared to a BRD-@ .


As many as @ % more patients were treated with experimental vs. control in the DAD-@ than with the BRD-@ ( experimental vs. control ratio : @ vs. @ ) , and as many as @ % more in the DAD-@ than with the DAD-@ ( @ vs. @ ) .


We illustrate the DAD-@ using a case study in lung cancer .


In the spectrum of Phase II designs , the direct assignment design , especially with two IA , provides a middle ground with desirable statistical properties and likely appeal to both clinicians and patients .


The success of laparoscopic surgery is due to the less surgical trauma , including less operative pain , complications and better cosmetics .


Objective of our study was to compare in two blind randomized groups of patients , the surgical outcome of total extra-peritoneal ( TEP ) inguinal hernia repair using either single-port or conventional surgical technique .


We will report our interim results in the first group of @ patients .


Our study is a prospective , randomized , controlled clinical trial conducted from August @ to June @ .


Fifty patients aged between @ and @ years undergoing surgery for unilateral inguinal hernia were randomised into two groups : conventional laparoscopic TEP inguinal hernia repair versus single-port TEP repair .


Clinical data on patient demographics , surgical technique and findings , postoperative complications and pain scores were collected .


Primary endpoint is the postoperative pain while secondary endpoints are recurrence , chronic pain , postoperative hospital stay and complications .


Out of the @ patients , @ underwent single-port hernia TEP repair and @ had conventional @-port TEP hernia repair after randomization .


Mean operative time was @ ( @ ) min in the multiport group and @ ( @ ) min in the single-port group , respectively ( P = @ ) .


Mean hospital stay was @ ( @ ) h in the conventional group and @ ( @ ) h in the single-port group ( P = @ ) .


No statistically significant differences were observed between the two groups for postoperative complications , and no recurrence reported at @ months follow-up .


There was no significant difference in the pain scores ( visual analog scale ) between the two groups at regular intervals post surgery .


The outcomes after laparoscopic TEP inguinal hernia repair with a single-port device are comparable to the standard three-port technique .


Post-dural puncture headache ( PDPH ) is the most frequent complication of procedures associated with dural puncture for spinal anesthesia or following accidental dural puncture during epidural anesthesia .


Since invasive treatments have known complications , pharmacologic management may be preferable .


The aim of this study was to evaluate and compare the efficacy of theophylline and Acetaminophen in treatment of PDPH .


In this single-blind randomized clinical trial , @ patients with Class I physical status according to ASA classification system , who suffered from PDPH were enrolled .


Patients in Theophylline group were received theophylline tablet @ mg three times per day , and in the other group acetaminophen @ mg three times per day was administered .


Pain intensity was assessed @ , @ , and @ hour after drug administration using @-@ cm Visual Analog Scale .


The main VAS values is significantly lower in theophylline group in comparison with the acetaminophen group at @ ( @ + / - @ vs. @ + / - @ ) , @ ( @ + / - @ vs. @ + / - @ ) , and @ ( @ + / - @ vs. @ + / - @ ) hours after drug administration ( p < @ ) .


No adverse effects were reported .


Theophylline is a safe and effective treatment for PDPH .


It may be tried in PDPH patients before using any invasive technique .


Further investigations studying other Methylxanthines are recommended as well .


There is currently a lack of evidence-based therapies that are safe and effective for plaque-type morphea .


We aimed to evaluate the therapeutic potential and safety profile of imiquimod @ % cream in plaque-type morphea .


We enrolled @ adult patients from two Canadian centers with histologically confirmed plaque-type morphea .


Imiquimod @ % was applied to a representative plaque , and vehicle was applied to a control plaque for @ months .


Treatment efficacy was assessed with the Dyspigmentation , Induration , Erythema , and Telangiectasias ( DIET ) score , histology , and ultrasound evaluation .


Twenty-two patients completed the entire length of the study .


Imiquimod @ % was superior to vehicle in reducing DIET scores at @ , @ , @ , and @ months ( p < @ ) .


Induration demonstrated the greatest response .


Histologic evaluation showed significant improvement or resolution of disease .


However , no ultrasonographic differences were found in dermal and hypodermal thicknesses between the treatment and vehicle groups ( p > @ ) .


Adverse effects were minimal and well tolerated .


Recent observational studies have suggested that the use of selective serotonin reuptake inhibitors is associated with an increased fracture risk and an accelerated bone loss , although conflicting results have been reported .


Furthermore , because many of these studies have been performed in depressed women , confounding by indication may influence these findings .


The objective of the study was to determine whether selective serotonin reuptake inhibitors affect bone metabolism Design : This was a randomized controlled trial .


The study was conducted in four US clinical sites .


Healthy peri - and postmenopausal women participated in the study .


The intervention was escitalopram ( @-@ mg/d ) for the treatment of vasomotor symptoms .


Serum carboxyterminal collagen crosslinks ( CTX ) and serum amino-terminal propeptide of type I collagen ( P@NP ) were measured .


One hundred forty-one peri - or postmenopausal nondepressed women ( mean age @ y , SD @ ) had baseline and @-week follow-up samples available for analysis and were included in the study ( @ escitalopram , @ placebo ) .


The groups were balanced across a broad range of baseline characteristics , including age , race , body mass index , smoking status , and mood symptoms .


The between-group differences in the change in CTX and P@NP from baseline to week @ were compared by a repeated-measures linear regression model adjusted for race , clinical center , and baseline measurement .


Treatment with escitalopram reduced serum P@NP by @ ng/mL on average -LSB- @ % confidence interval ( CI ) -@ , @ -RSB- compared with a reduction of @ ng/mL ( @ % CI -@ , @ ) in the placebo group ( P = @ ) .


Similarly , serum CTX decreased @ ng/mL on average ( @ % CI -@ , @ ) in the escitalopram group compared with @ ng/mL ( @ % CI -@ , @ ) in the placebo group ( P = @ ) .


The results were similar when the analysis was restricted to those women whose adherence to study medication was @ % or greater .


Although the study was limited to @ weeks , these results suggest that escitalopram does not significantly alter bone metabolism in the short term .


To evaluate the longer-term safety and efficacy of secukinumab , a fully human monoclonal antiinterleukin-@A antibody , in patients with rheumatoid arthritis .


In this @-week , double-blind , placebo-controlled ( up to Week @ ) study ( NCT@ ) , patients responding inadequately to disease-modifying antirheumatic drugs ( DMARD ) or biologics were randomized to receive monthly subcutaneous injections of secukinumab ( @ , @ , @ , or @ mg ) , or placebo .


The efficacy and safety results up to Week @ have been reported previously .


Here , efficacy results from Week @ to @ and safety results from Week @ to @ are presented .


Of @ patients randomized , @ ( @ % ) completed the study .


Patients with improved American College of Rheumatology ( ACR ) and @-joint Disease Activity Score ( DAS@ ) C-reactive protein ( CRP ) responses at Week @ sustained their responses through Week @ .


In patients taking @ mg of secukinumab , responses were improved through Week @ ( ACR@ : Week @ = @ % , Week @ = @ % ; DAS@-CRP @ : Week @ = @ % , Week @ = @ % ) .


The rate of adverse events ( AE ) from weeks @ to @ was @ % , with most AE being mild to moderate in severity .


The overall rate of infections was @ % , most being mild .


The most predominant infection was nasopharyngitis , and was not associated with dose or concurrent neutropenia .


Serious AE were reported in @ patients ( @ % ) .


There were @ reports of malignancies ( ovarian , lung , basal cell ) , and no deaths between weeks @ and @ .


Patients with active RA who failed to respond to DMARD and other biologics showed an improvement after longterm treatment with @ mg of secukinumab .


The frequency of AE remained stable over time and secukinumab had a consistent safety profile over @ weeks .


To compare the efficacy of ondansetron alone and combination of ondansetron and dexamethasone in preventing post-operative nausea and vomiting in patients undergoing laparoscopic cholecystectomy .


The randomised control trial was conducted from April @ to August @ , @ , at the Liaquat National Hospital , Karachi , and comprised @ American Society of Anaesthesiology I and II patients undergoing laparoscopic cholecystectomy .


Half of the subjects comprised Group A and received ondansetron alone , while Group B received combination of ondansetron and dexamethasone .


They were randomised by opaque envelope method .


Group A received ondansetron @ mg while Group B received ondansetron @ mg with dexamethasone @ mg , @ minute before induction .


Post-operatively patients were observed for six hours for any episode of nausea or vomiting , or whether the patients required any rescue anti emetic .


SPSS @ was used for statistical analysis .


Patients receiving ondansetron alone showed @ ( @ % ) with incidence of nausea or vomiting while the other group showed @ ( @ % ) .


This difference was statistically significant ( p < @ ) .


Combination of ondansetron and dexamethasone was more efficacious compared to ondansetron alone in the prevention of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy .


To explore the long-term effects of the uvulopalatopharyngoplasty ( UPPP ) combined with oral appliance ( OA ) in the treatment of obstructive sleep apnea hypopnea syndrome ( OSAHS ) .


Thirty patients with severe OSAHS confirmed by polysomnography ( PSG ) according to their apnea hypopnea index ( AHI ) and lowest SaO@ during sleep were selected using random permutation table and divided into only UPPP group ( U group , n = @ ) and UPPP with OA group ( UA group , n = @ ) .


The follow-up period was @ years .


PSG was performed in @ year and @ years after operation .


AHI , lowest SaO@ and Tmax were tested and evaluated .


The effectiveness of two groups was the same after @ year .


Two years after operation , the values -LSB- AHI : ( @ @ ) times/h ; lowest SaO@ : ( @ @ ) % and Tmax : ( @ @ ) s -RSB- in UA group were better than that -LSB- AHI : ( @ @ ) times/h ; lowest SaO@ : ( @ @ ) % and Tmax : ( @ @ ) s -RSB- in U group .


The number of effectiveness was @ and the number of ineffectiveness was @ in U group , while in UA group , the number of effectiveness was @ and the number of ineffectiveness was @ ( P < @ ) .


Long-term result of combined treatment was better than that of UPPP only .


Cognitive behavioral therapy ( CBT ) is an effective treatment for panic disorder with agoraphobia ( PD/AG ) .


It is unknown , how variants of CBT differentially modulate brain networks involved in PD/AG .


This study was aimed to evaluate the effects of therapist-guided ( T + ) versus self-guided ( T - ) exposure on the neural correlates of fear conditioning in PD/AG .


In a randomized , controlled multicenter clinical trial in medication-free patients with PD/AG who were treated with @ sessions of manualized CBT , functional magnetic resonance imaging ( fMRI ) was used during fear conditioning before ( t@ ) and after CBT ( t@ ) .


Quality-controlled fMRI data from @ patients and @ healthy subjects ( HS ) were obtained .


Patients were randomized to two variants of CBT ( T + , n = @ , and T - , n = @ ) .


The interaction of diagnosis ( PD/AG , HS ) , treatment group ( T + , T - ) , time point ( t@ , t@ ) and stimulus type ( conditioned stimulus : yes , no ) revealed activation in the left hippocampus and the occipitotemporal cortex .


The T + group demonstrated increased activation of the hippocampus at t@ ( t@ > t@ ) , which was positively correlated with treatment outcome , and a decreased connectivity between the left inferior frontal gyrus and the left hippocampus across time ( t@ > t@ ) .


After T + exposure , contingency-encoding processes related to the posterior hippocampus are augmented and more decoupled from processes of the left inferior frontal gyrus , previously shown to be dysfunctionally activated in PD/AG .


Linking single procedural variants to neural substrates offers the potential to inform about the optimization of targeted psychotherapeutic interventions .


Early nutrition influences metabolic programming and long-term health .


We explored the urinary metabolite profiles of @ premature infants ( birth weight < @ g ) randomized to an enhanced or a standard diet during neonatal hospitalization .


Metabolomics using nuclear magnetic resonance spectroscopy ( NMR ) was conducted on urine samples obtained during the first week of life and thereafter fortnightly .


The intervention group received significantly higher amounts of energy , protein , lipids , vitamin A , arachidonic acid and docosahexaenoic acid as compared to the control group .


Enhanced nutrition did not appear to affect the urine profiles to an extent exceeding individual variation .


However , in all infants the glucogenic amino acids glycine , threonine , hydroxyproline and tyrosine increased substantially during the early postnatal period , along with metabolites of the tricarboxylic acid cycle ( succinate , oxoglutarate , fumarate and citrate ) .


The metabolite changes correlated with postmenstrual age .


Moreover , we observed elevated threonine and glycine levels in first-week urine samples of the small for gestational age ( SGA ; birth weight < @th percentile for gestational age ) as compared to the appropriate for gestational age infants .


This first nutri-metabolomics study in premature infants demonstrates that the physiological adaptation during the fetal-postnatal transition as well as maturation influences metabolism during the breastfeeding period .


Elevated glycine and threonine levels were found in the first week urine samples of the SGA infants and emerged as potential biomarkers of an altered metabolic phenotype .


This study evaluated the efficacy and tolerability of tapentadol extended release ( ER ) for the management of chronic pain associated with diabetic peripheral neuropathy ( DPN ) .


Adults with moderate to severe DPN pain were titrated to tapentadol ER @-@ mg bid during a @-week open-label period ; patients with @-point reduction in pain intensity ( @-point numerical rating scale ) at end of titration were randomized to receive placebo or tapentadol ER ( optimal dose from titration ) for @ weeks ( double-blind , fixed-dose maintenance phase ) .


The primary end point was mean change in average pain intensity from the start to week @ ( last observation carried forward -LSB- LOCF -RSB- ) of the double-blind maintenance phase .


A total of @ patients completed the titration period ; @ patients ( placebo , n = @ ; tapentadol ER , n = @ ) were randomized and received one or more doses of double-blind study medication .


Mean ( SD ) pain intensity ( observed case ) was @ ( @ ) at the start and @ ( @ ) at week @ of the open-label titration period ( mean -LSB- SD -RSB- change , -@ -LSB- @ -RSB- ) .


The mean ( SD ) change in pain intensity ( LOCF ) from start of double-blind treatment to week @ was as follows : placebo , @ ( @ ) ; tapentadol ER , @ ( @ ; least squares mean difference , -@ -LSB- @ % CI -@ to -@ -RSB- ; P < @ ) .


Treatment-emergent adverse events ( @ % ) in the tapentadol ER group during the double-blind maintenance phase were nausea ( @ % ) and vomiting ( @ % ) .


Tapentadol ER ( @-@ mg bid ) was effective and well tolerated for the management of moderate to severe chronic pain associated with DPN .


Lenvatinib , an oral inhibitor of vascular endothelial growth factor receptors @ , @ , and @ , fibroblast growth factor receptors @ through @ , platelet-derived growth factor receptor , RET , and KIT , showed clinical activity in a phase @ study involving patients with differentiated thyroid cancer that was refractory to radioiodine ( iodine-@ ) .


In our phase @ , randomized , double-blind , multicenter study involving patients with progressive thyroid cancer that was refractory to iodine-@ , we randomly assigned @ patients to receive lenvatinib ( at a daily dose of @ mg per day in @-day cycles ) and @ patients to receive placebo .


At the time of disease progression , patients in the placebo group could receive open-label lenvatinib .


The primary end point was progression-free survival .


Secondary end points included the response rate , overall survival , and safety .


The median progression-free survival was @ months in the lenvatinib group and @ months in the placebo group ( hazard ratio for progression or death , @ ; @ % confidence interval , @ to @ ; P < @ ) .


A progression-free survival benefit associated with lenvatinib was observed in all prespecified subgroups .


The response rate was @ % in the lenvatinib group ( @ complete responses and @ partial responses ) and @ % in the placebo group ( P < @ ) .


The median overall survival was not reached in either group .


Treatment-related adverse effects of any grade , which occurred in more than @ % of patients in the lenvatinib group , were hypertension ( in @ % of the patients ) , diarrhea ( in @ % ) , fatigue or asthenia ( in @ % ) , decreased appetite ( in @ % ) , decreased weight ( in @ % ) , and nausea ( in @ % ) .


Discontinuations of the study drug because of adverse effects occurred in @ patients who received lenvatinib ( @ % ) and @ patients who received placebo ( @ % ) .


In the lenvatinib group , @ of @ deaths that occurred during the treatment period were considered to be drug-related .


Lenvatinib , as compared with placebo , was associated with significant improvements in progression-free survival and the response rate among patients with iodine-@-refractory thyroid cancer .


Patients who received lenvatinib had more adverse effects .


( Funded by Eisai ; SELECT ClinicalTrials.gov number , NCT@ . )


To investigate the effect of spa adjuvant therapy on diabetic lower extremity arterial disease ( LEAD ) .


@ patients with type II diabetes were separated into three groups according to the degree of lower extremity vascular stenosis .


Patients within each group were then randomly divided to receive no treatment ( control ) or spa adjuvant therapy ( treatment ) .


Clinical symptoms , blood pressure and hemodynamic analyses were compared between control and treatment groups by Chi square or t-test .


After adjuvant therapy with spa , patients ' pain , numbness , and cold sensation were significantly improved compared with control groups ( P < @ ) .


Spa adjuvant therapy also significantly increased the dorsalis pedis pulse and systolic peak velocity ratio of patients with mild lower extremity vascular stenosis compared with control groups ( P < @ ) , while there were no significant differences between the two groups for patients with moderate and severe stenosis ( P > @ ) .


Both in the spa and control groups , there were no significant differences before and after medication for fasting , @-h postprandial blood glucose and glycosylated hemoglobin ( HbA@C ) analyses ( P > @ ) .


Spa adjuvant therapy can significantly alleviate lower extremity pain , numbness , and cold sensory symptoms in diabetic LEAD patients with stenosis .


Moreover , in LEAD patients with mild stenosis , spa adjuvant therapy also improves the dorsalis pedis pulse and systolic peak velocity ratio , suggesting a potential role for spa therapy as an early intervention strategy to treat the initial stages of disease .


A @-month double-blind sham-surgery-controlled trial assessing adeno-associated virus type @ ( AAV@ ) - neurturin injected into the putamen bilaterally failed to meet its primary endpoint , but showed positive results for the primary endpoint in the subgroup of subjects followed for @ months and for several secondary endpoints .


Analysis of postmortem tissue suggested impaired axonal transport of neurturin from putamen to substantia nigra .


In the present study , we tested the safety and efficacy of AAV@-neurturin delivered to putamen and substantia nigra .


We performed a @ - to @-month , multicenter , double-blind trial in patients with advanced Parkinson disease ( PD ) who were randomly assigned to receive bilateral AAV@-neurturin injected bilaterally into the substantia nigra ( @ @ ( @ ) vector genomes ) and putamen ( @ @ ( @ ) vector genomes ) or sham surgery .


The primary endpoint was change from baseline to final visit performed at the time the last enrolled subject completed the @-month evaluation in the motor subscore of the Unified Parkinson 's Disease Rating Scale in the practically defined off state .


Fifty-one patients were enrolled in the trial .


There was no significant difference between groups in the primary endpoint ( change from baseline : AAV@-neurturin , -@ ; sham , -@ ; p = @ ) or in most secondary endpoints .


Two subjects had cerebral hemorrhages with transient symptoms .


No clinically meaningful adverse events were attributed to AAV@-neurturin .


AAV@-neurturin delivery to the putamen and substantia nigra bilaterally in PD was not superior to sham surgery .