LV end systolic volume index was also evaluated as a predictor of mortality/morbidity .


Of @ randomized subjects , @ had paired Doppler echocardiogram data for @ analyses at @ , @ , @ , or @ months .


Biventricular pacing significantly reduced LV volume indices and intraventricular mechanical delay , and improved LV ejection fraction , consistent with LV reverse remodeling .


These parameters showed little change with right ventricular pacing alone , indicating no systematic reverse remodeling with right ventricular pacing .


LV end systolic volume index was predictive of mortality/morbidity ; the estimated risk increased up to @ % for every @ mL/m ( @ ) increase in LV end systolic volume index .


LV end systolic volume index is a significant predictor of mortality/morbidity in this population .


Cardiac structure and function are improved with biventricular pacing for patients with atrioventricular block and LV systolic dysfunction .


To compare the efficacy , safety and postoperative pain of mechanical versus transepithelial photorefractive keratectomy ( PRK ) techniques .


Cornea and refractive surgery subspecialty .


Prospective clinical trial .


This prospective comparative study included @ eyes of @ patients with myopia who received mechanical PRK ( m-PRK ) in @ eye and transepithelial PRK ( t-PRK ) in the contralateral eye .


The mean patient age was @ years ( range @-@ years ) .


Postoperative uncorrected distance visual acuity ( UDVA ) , corrected distance visual acuity ( CDVA ) , manifest refractions , postoperative epithelial healing time , surgical time , postoperative pain rating and corneal haze were recorded .


At week @ , statistically the UDVA was significantly better in the t-PRK eyes ; however , at @ months , similar refractive stability was achieved in both groups .


The mean spherical equivalent ( SE ) decreased from -@ D ( m-PRK eyes ) and -@ D ( t-PRK eyes ) at baseline to -@ D and -@ D , respectively , after @ year .


Surgical time was @ s in m-PRK eyes and @ s in t-PRK eyes .


On postoperative days @ and @ , using the global assessment rating , @ % of mPRK eyes that had pain , reported more pain than that reported for the tPRK eyes .


In addition , m-PRK treated eyes demonstrated higher mean pain scores based on the @-point numerical rating scale and Visual Analogue Scale ( VAS ) .


The mean time to complete epithelial healing was @ days ( t-PRK ) and @ days ( m-PRK ) .


t-PRK for mild-to-moderate myopia was more comfortable than conventional m-PRK ; patients had less pain , and faster healing time .


To report late toxicity outcomes from a randomized trial comparing conventional and hypofractionated prostate radiation therapy and to identify dosimetric and clinical parameters associated with late toxicity after hypofractionated treatment .


Men with localized prostate cancer were enrolled in a trial that randomized men to either conventionally fractionated intensity modulated radiation therapy ( CIMRT , @ Gy in @-Gy fractions ) or to dose-escalated hypofractionated IMRT ( HIMRT , @ Gy in @-Gy fractions ) .


Late ( @ days after completion of radiation therapy ) genitourinary ( GU ) and gastrointestinal ( GI ) toxicity were prospectively evaluated and scored according to modified Radiation Therapy Oncology Group criteria .


@ men received CIMRT and @ men received HIMRT .


The median age was @ , and the median follow-up time was @ years .


Twenty-eight percent had low-risk , @ % had intermediate-risk , and @ % had high-risk disease .


There was no difference in late GU toxicity in men treated with CIMRT and HIMRT .


The actuarial @-year grade @ GU toxicity was @ % after CIMRT and @ % after HIMRT ( P = @ ) .


There was a nonsignificant numeric increase in late GI toxicity in men treated with HIMRT compared with men treated with CIMRT .


The actuarial @-year grade @ GI toxicity was @ % after CIMRT and @ % after HIMRT ( P = @ ) .


In men receiving HIMRT , the proportion of rectum receiving @ Gy , @ Gy , @ Gy , and @ Gy was associated with the development of late GI toxicity ( P < @ ) .


The @-year actuarial grade @ GI toxicity was @ % in men with R@ @ Gy @ % but only @ % in men with R@ @ Gy < @ % ( P = @ ) .


Dose-escalated IMRT using a moderate hypofractionation regimen ( @ Gy in @-Gy fractions ) can be delivered safely with limited grade @ or @ late toxicity .


Minimizing the proportion of rectum that receives moderate and high dose decreases the risk of late rectal toxicity after this hypofractionation regimen .


High circulating levels of osteoprotegerin ( OPG ) carry prognostic impact in cohorts with various cardiovascular diagnoses .


With the present study , we aim to investigate the role of OPG within the scale of myocardial damage .


This study includes @ consecutive patients with acute ST-elevation myocardial infarction randomized to primary percutaneous coronary intervention ( pPCI ) or pPCI and remote ischemic per-conditioning .


Salvage index via myocardial single-photon emission CT assessment ( data available in @ % of the patients ) was performed , and derived from Day @ ( myocardial area at risk ) and Day @ ( final infarct size ) .


Plasma OPG levels were measured using an in-house immunoassay .


A combined end-point of all-mortality , myocardial infarction , stroke , readmission for heart failure and ischemic stroke/transient ischemic attack ( Major Adverse Cardiac and Cerebrovascular Events -LSB- MACCE -RSB- ) was used for follow-up ; @ ( @-@ months ) .


High OPG levels were associated with the severity of cardiovascular disease .


During follow-up , OPG was a predictor of MACCE ( unadjusted , HR : @ , @ % CI : @-@ @ , P = @ ) .


Adjustments for age , gender , and body mass index preserved the independent predictive power of OPG .


However , OPG levels were neither associated with salvage index nor with the final infarct size .


Remote ischemic per-conditioning had no effect on OPG levels .


Despite absent association between OPG levels and the scale of myocardial damage , high OPG levels predict a significantly increased risk of MACCE .


Life expectancy in patients with schizophrenia is reduced by @years for males and @years for females compared to the general population .


About @ % of the excess mortality is due to physical illnesses , with cardiovascular disease being the single largest cause of death .


The CHANGE trial is an investigator-initiated , independently funded , randomized , parallel-group , superiority , multi-centre trial with blinded outcome assessment .


@ patients aged @years or above , diagnosed with schizophrenia spectrum disorders and increased waist circumference , will be recruited and randomized @:@:@ to @-months interventions .


We will compare the effects of @ ) affiliation to the CHANGE team , offering a tailored , manual-based intervention targeting physical inactivity , unhealthy dietary habits , and smoking , and facilitating contact to their general practitioner to secure medical treatment of somatic comorbidity ; versus @ ) affiliation to a care coordinator who will secure guideline-concordant monitoring and treatment of somatic comorbidity by facilitating contact to their general practitioner ; versus @ ) treatment as usual to evaluate the potential add-on effects of lifestyle coaching plus care coordination or care coordination alone to treatment as usual .


The primary outcome is the @-year risks of cardiovascular disease assessed at @months after randomization .


The premature mortality observed in this vulnerable population has not formerly been addressed specifically by using composite surrogate outcomes for mortality .


The CHANGE trial expands the evidence for interventions aiming to reduce the burden of metabolic disturbances with a view to increase life expectancy .


Here , we present the trial design , describe the methodological concepts in detail , and discuss the rationale and challenges of the intermediate outcomes .


Implanted insulin pumps using the peritoneal route provide long-term improvement of glucose control compared with subcutaneous insulin therapy in type @ diabetes ( T@D ) patients .


The stability of insulin preparation is critical for a safe use in implanted pumps .


Insuman implantable ( ) ( @IU/mL ) ( Sanofi-Aventis Deutschland GmbH , Frankfurt am Main , Germany ) , a recombinant human insulin , has been developed as a replacement for Insuplant ( ) ( Aventis Pharma , Frankfurt am Main , Germany ) , a semisynthetic insulin , the only one used so far .


The aim of the study was to demonstrate the noninferiority of Insuman versus Insuplant , in terms of safety and effectiveness when used in implanted pumps .


The patients enrolled , currently treated for T@D by the Medtronic MiniMed ( Northridge , CA ) implantable pump model @ with Insuplant , were randomized into two study arms and received either Insuman or Insuplant for four pump refill cycles .


Each pump refill cycle was @ days .


The co-primary end points included glycated hemoglobin ( HbA@c ) change from baseline and pump infusion accuracy .


In total , @ patients were randomized .


Noninferiority of Insuman versus Insuplant was demonstrated both for the HbA@c change from baseline ( as a percentage ) with intergroup difference of @ % confidence interval ( -@ ; +@ ) and for the infusion accuracy assessed by the measured percentage of error at pump refill , as shown by intergroup difference of @ % confidence interval ( -@ ; -@ ) , in per-protocol populations , although the insulin daily dose was similar .


Severe hypoglycemia occurred at least once in @ versus @ patients , respectively , and metabolic or technical adverse events were comparable .


Findings suggest that Insuman can safely and effectively replace Insuplant in implanted pumps .


To compare laser photocoagulation plans for diabetic macular edema ( DME ) using fluorescein angiography ( FA ) versus optical coherence tomography ( OCT ) thickness map superimposed on the retina .


Fourteen eyes with DME undergoing navigated laser photocoagulation with navigated photocoagulator had FA taken using the same instrument .


Optical coherence tomography central retinal thickness map was imported to the photocoagulator and with same magnification aligned onto the retina .


Three retina specialists placed laser spot marks separately on FA and OCT image in a masked fashion .


The spots placed by each physician were compared between FA and OCT and among physicians .


The area of dye leakage on FA and increased central retinal thickness on OCT of the same eye were also compared .


The average number of spots using FA and OCT template was @ and @ , respectively ( P = @ ) .


The average area of dye leakage was @ mm , whereas the average area of increased central retinal thickness on OCT of the same eye was @ mm ( P = @ ) .


There is variability in the treatment planning for macular photocoagulation with a tendency to place more spots when guided by OCT than by FA .


Integration of OCT map aligned to the retina may have an impact on treatment plan once such information is available .


To evaluate the effectivity of a combined intervention of information and communication to reduce magnetic resonance imaging ( MRI ) anxiety using prolactin and cortisol as biochemical markers and State Trait Anxiety Inventory ( STAI ) .


This study is a randomized prospective research .


Sample size was @ patients .


Fourteen patients were enrolled as study group , compared to @ patients as control group .


Blood samples were collected by venous sampling , and STAI was filled before and after scan .


State anxiety inventory was used twice .


Study group received a standard information about MRI scans and were communicated with @ minute intervals via intercom ; control group had no intervention .


Blood samples were carried in ice to be centrifuged and stored as soon as they were taken to study prolactin and cortisol .


Data were stored and analyzed by SPSS @ .


P value for significance was accepted as @ .


Prolactin-pre , prolactin-post , cortisol-pre , cortisol-post , cortisol percent increase , Trait Anxiety Inventory ( TAI ) , SAI ( State Anxiety Inventory ) pre-scan and post-scan levels were similar between demographic groups .


Cortisol-pre levels were similar between study and control , however prolactin-pre levels were significantly higher in control group .


Study group had @ % lower cortisol level post-scan , whereas control group had @ % increase .


Study and control groups had similar Trait Anxiety and SAI-pre scores .


SAI-post scores were lower in study group when compared with control group .


Study group also had lower SAI-post scores than SAI-pre , whereas control group had higher .


MRI anxiety can be reduced by information and communication .


This combined method is shown to be effective and should be used during daily radiology routine .


Contrast-induced nephropathy ( CIN ) is a serious condition in patients with ST-segment-elevation myocardial infarction treated with primary percutaneous coronary intervention .


We compared the risk of acute CIN and the influence of preventive strategies in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention .


A total of @ patients were randomized in the Prevention of Contrast-induced Nephropathy in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention ( CINSTEMI ) trial .


Patients were randomly assigned in a @:@:@:@ ratio to receive hydration with sodium chloride together with @ of @ prophylactic regimes ( @ ) N-acetylcysteine ( NAC ) , ( @ ) sodium bicarbonate ( NaHCO@ ) infusion , ( @ ) NAC in combination with NaHCO@ , or ( @ ) hydration with sodium chloride infusion alone .


Patients in cardiogenic shock were excluded .


Acute CIN was defined as an increase in serum creatinine concentration > @ % from the baseline value within a @-day period .


Overall , CIN occurred in @ ( @ % ) patients .


The prevention treatment with NAC , NaHCO@ , or the combined NAC and NaHCO@ did not reduce the rate of CIN significantly compared with hydration with intravenous sodium chloride infusion alone ( @ % versus @ % versus @ % versus @ % ; P = NS ) .


However , an increase in serum creatinine > @ % from the baseline value to @ day was significantly lower in patients treated with combined NAC and NaHCO@ ( @ % versus @ % versus @ % versus @ % ; P = @ ) .


Treatment with NAC or NaHCO@ did not reduce the rate of acute CIN significantly .


Combined treatment with NAC and NaHCO@ may reduce the risk of renal dysfunction after @ days .


To evaluate the efficacy and safety of subcutaneous blisibimod , an inhibitor of B cell activating factor , in patients with systemic lupus erythematosus ( SLE ) in a dose-ranging Phase @b clinical trial .


@ patients with SLE with anti-double stranded DNA or antinuclear antibodies and Safety of Estrogens in Lupus Erythematosus National Assessment-SLE Disease Activity Index ( SELENA-SLEDAI ) score @ at baseline were randomised to receive placebo or blisibimod at one of @ dose levels .


The primary end point , measured at Week @ , was the SLE Responder Index-@ ( SRI-@ , meeting established SRI criteria but with @ point improvement in SELENA-SLEDAI ) .


Although SRI-@ response rates were not significantly improved in the pooled blisibimod groups compared with placebo , they were higher in subjects randomised to the highest dose of blisibimod ( @mg once-weekly ( QW ) ) compared with pooled placebo , from Week @ to Week @ , reaching statistical significance at Week @ ( p = @ ) .


SRI response rates compared with placebo were higher still in subjects who attained SELENA-SLEDAI improvements of @ , and in a subgroup of patients with severe disease ( SELENA-SLEDAI @ and receiving corticosteroids at baseline ) .


In subjects with protein : creatine ratios of @-@ at baseline , significant reductions in proteinuria were observed with blisibimod .


Significant ( p < @ ) changes in anti-double stranded DNA antibodies , complement C@ and C@ , and reductions in B cells were observed with blisibimod.No imbalances in serious adverse events or infections ( @/@ and @/@ ) , deaths ( @/@ and @/@ ) and malignancies ( @/@ and @/@ ) were reported for blisibimod compared with placebo .


This study successfully identified a safe , effective and convenient dose , study population and end point for evaluation of blisibimod effect in Phase @ .


To assess the efficacy and safety of Xifeng Zhidong Tablet ( XZT ) in treating tic disorder children patients of internal disturbance of Gan-wind with phlegm syndrome ( IDGWPS ) .


A stratified randomized , double-blinded , parallel control of placebo , multi-center trial was conducted in @ subjects from @ hospitals in China .


They were randomly assigned to @ groups , the test group and the control group , @ in each group .


Those in the test group were treated with XZT , while those in the control group were treated with placebos .


The therapeutic course was @ weeks for all .


The effectiveness indicators covered main indicators and secondary indicators .


Yale global tic severity scale ( YGTSS ) was taken as the main indicators .


The amelioration of social function impairment , efficacy , single index of Chinese medical syndromes , Chinese medical syndrome efficacy as well as disappearance rate of single Chinese medical symptoms were evaluated as secondary indicators .


The safety indicators included clinical adverse events , vital signs , blood/urine/stool routines , renal and liver functions , and electrocardiogram ( ECG ) .


As for main indicators , the score of YGTSS decreased from @ + / - @ to @ + / - @ in the test group , while it decreased from @ + / - @ to @ + / - @ in the control group , showing statistical difference when compared with the same group before treatment ( P < @ ) .


Besides , the decrement was more significant in the test group after treatment ( P < @ ) .


As for secondary indicators , the total effective rate was @ % in the test group and @ % in the controlled group , showing statistical difference between the two groups ( P < @ ) .


As for social function impairment , @,@ , @ , @ , @ case ( s ) in the test group were ranked as normal , minimal , mild , moderate , obvious degree , while @ , @ , @ , @ , and @ case ( s ) in the control group were ranked as normal , minimal , mild , moderate , obvious degree .


Better effect was obtained in the test group ( P < @ ) .


As for Chinese medical syndrome efficacy , it was @ % in the test group and @ % in the control group ( P < @ ) .


As for single index of Chinese medical syndromes , the disappearance rate of motor tics , irritability , dreaminess , abnormal tongue proper , abnormal tongue fur , and abnormal tongue pulse condition was @ % , @ % , @ % , @ % , @ % , and @ % , respectively in the test group , while they were @ % , @ % , @ % , @ % , @ % , and @ % , respectively in the control group .


Better results were shown in the test group ( P < @ ) .


Totally @ adverse events occurred .


The incidence of adverse events was @ % in the test group and @ % in the control group .


After @ weeks of XZT treatment , the integral of YGTSS could be obviously reduced , the degree of social function impairment ameliorated , and Chinese medical syndromes improved .


In addition , no adverse reaction occurred in this study .


The study sought to evaluate the influence of gastroesophageal reflux disease ( GERD ) and allergy on subacute rhinitis in infants .


Mothers of @ infants with subacute rhinitis completed the Infant Gastroesophageal Reflux Questionnaire Revised .


Participants with GERD were randomized to undergo one of the following regimens for @ days : use of fluorometholone nasal drops with positional and feeding changes ; positional and feeding changes ; or a placebo .


The daily amount of nasal secretion decreased by @ % ( p < @ ) , the intensity of swallowing difficulty by @ % ( p < @ ) , and the incidence of uneasiness by @ % ( p < @ ) in infants treated with nasal glucocorticoid and positional and feeding changes ; and the percentage differences in the amount of nasal secretion ( p < @ ) , feeding difficulty ( p < @ ) , and uneasiness ( p < @ ) were greater than those in the group treated with positional and feeding changes .


The infants treated with placebo did not improve .


The influence of nasal allergy was nonsignificant .


Gastroesophageal reflux disease might contribute to aggravation of subacute rhinitis in infants .


Several rehabilitation programmes aim at reducing the impact of fatigue in MS patients .


Acute and chronic fatigue should require different management .


To assess the effects of individually tailored , multidisciplinary outpatient rehabilitation ( MDR ) on chronic fatigue .


Forty-eight ambulatory MS patients with chronic fatigue were randomized to MDR or to MS-nurse consultation .


Fatigue was assessed by the Checklist Individual Strength ( CIS-@R ) .


Secondary outcomes included the Modified Fatigue Impact Scale , Fatigue Severity Scale , Functional Independence Measure , Disability and Impact Profile ( DIP ) , Multiple Sclerosis Impact Scale and the Impact on Participation and Autonomy ( IPA ) .


The primary outcome measure CIS-@R overall score showed no significant differences between groups at @ weeks ( P = @ ) and @ weeks follow-up ( P = @ ) , nor for subscales ( t = @ and t = @ , @ P@ @ ) .


No significant within-group effects were found for both groups with respect to the primary ( @ p@ @ ) and secondary ( @ p@ @ ) outcome measures from baseline to @ or @ weeks .


Multidisciplinary rehabilitation was not more effective in terms of reducing self-reported fatigue in MS patients compared to MS-nurse consultation .


Our results suggest that chronic fatigue in patients with MS may be highly invariant over time , irrespective of interventions .


Somatostatin analogues are commonly used to treat symptoms associated with hormone hypersecretion in neuroendocrine tumors ; however , data on their antitumor effects are limited .


We conducted a randomized , double-blind , placebo-controlled , multinational study of the somatostatin analogue lanreotide in patients with advanced , well-differentiated or moderately differentiated , nonfunctioning , somatostatin receptor-positive neuroendocrine tumors of grade @ or @ ( a tumor proliferation index -LSB- on staining for the Ki-@ antigen -RSB- of < @ % ) and documented disease-progression status .


The tumors originated in the pancreas , midgut , or hindgut or were of unknown origin .


Patients were randomly assigned to receive an extended-release aqueous-gel formulation of lanreotide ( Autogel -LSB- known in the United States as Depot -RSB- , Ipsen ) at a dose of @ mg ( @ patients ) or placebo ( @ patients ) once every @ days for @ weeks .


The primary end point was progression-free survival , defined as the time to disease progression ( according to the Response Evaluation Criteria in Solid Tumors , version @ ) or death .


Secondary end points included overall survival , quality of life ( assessed with the European Organization for Research and Treatment of Cancer questionnaires QLQ-C@ and QLQ-GI .


NET@ ) , and safety .


Most patients ( @ % ) had no tumor progression in the @ to @ months before randomization , and @ % had hepatic tumor volumes greater than @ % .


Lanreotide , as compared with placebo , was associated with significantly prolonged progression-free survival ( median not reached vs. median of @ months , P < @ by the stratified log-rank test ; hazard ratio for progression or death , @ ; @ % confidence interval -LSB- CI -RSB- , @ to @ ) .


The estimated rates of progression-free survival at @ months were @ % ( @ % CI , @ to @ ) in the lanreotide group and @ % ( @ % CI , @ to @ ) in the placebo group .


The therapeutic effect in predefined subgroups was generally consistent with that in the overall population , with the exception of small subgroups in which confidence intervals were wide .


There were no significant between-group differences in quality of life or overall survival .


The most common treatment-related adverse event was diarrhea ( in @ % of the patients in the lanreotide group and @ % of those in the placebo group ) .


Lanreotide was associated with significantly prolonged progression-free survival among patients with metastatic enteropancreatic neuroendocrine tumors of grade @ or @ ( Ki-@ < @ % ) .


( Funded by Ipsen ; CLARINET ClinicalTrials.gov number , NCT@ ; EudraCT @-@-@ . )


Endoscopic treatment of early neoplastic lesions in oesophagus has evolved as a valid and less invasive alternative to surgical resection .


These endoscopic interventions are minimal invasive treatment options usually done with sedation on an outpatient basis .


The aim of this trial is to determine the safety and effectiveness of dexmedetomidine sedation compared to the standard used propofol TCI sedation during endoscopic oesophageal interventions .


The study will be performed as a randomized controlled trial .


The first @ consenting patients will be randomized to either the propofol or the dexmedetomidine group .


Following endoscopy patients and gastroenterologists have to fill in questionnaires ( PSSI , CSSI ) ( see abbreviations ) about their sedation experiences .


Additionally , patients have to accomplish the Trieger test before and after the procedure .


Patient monitoring includes time adapted HR , SO , ECG , NIBP , exCO , NICO , sweat conductance measurement , OAA/S , and the Aldrete score .


Effectiveness of sedation , classified by satisfaction levels and pain and sedation score measured by questionnaires is the primary outcome parameter .


Respiratory and hemodynamic complications are surrogate parameters for the secondary outcome parameter `` safety '' .


The acceptance level among patients after propofol sedation is high .


Dexmedetomidine is a relatively new representative for procedural sedation .


Has this new form of conscious sedation the potential to be safer and more effective for patients and endoscopists than propofol during endoscopic oesophageal interventions ?


Anemia is a common adverse event associated with telaprevir-based triple therapy of chronic , genotype @ hepatitis C. Identification of patients at risk of developing anemia could allow evaluation of suitability for therapy , and aid in determining frequency of anemia monitoring and treatment management .


This post-hoc analysis utilized data from the no lead-in telaprevir , peginterferon and ribavirin arm of the REALIZE study .


Anemia was defined as a single occurrence of hemoglobin < @ g/dl at any point during treatment .


Pre-treatment factors with potential to act as prognostic indicators of anemia including age , sex , BMI , and baseline hemoglobin were analysed by univariate and multivariate logistic regression analyses .


Nomograms ( graphical representations of risk factors ) were developed to predict the likelihood of developing anemia .


Among the @ patients , @ ( @ % ) had anemia , with @/@ ( @ % ) developing anemia on or before week @ .


Most patients developed anemia after week @ and an inverse correlation was found between week @ hemoglobin and the likelihood of developing anemia .


Overall , @ % of patients ( @/@ ) with week @ hemoglobin < @ g/dl subsequently developed anemia .


The multivariate analysis revealed older age ( > @ years ) , lower BMI ( @ mg/m ( @ ) ) and baseline hemoglobin ( continuous variable ) were significantly associated with the probability of developing anemia during telaprevir treatment .


These analyses indicate the potential of using predictive risk factors such as low baseline and on-treatment hemoglobin to identify patients at risk of developing anemia on telaprevir-based triple therapy , which may increase the potential for treatment success by careful patient monitoring .


After posterior urethral valve ablation , some boys are still have a hostile bladder .


We conducted a prospective randomized study to determine if Botox injection at the bladder neck will help improve vesical dysfunction in this subgroup of boys or not .


Twenty boys with history of posterior urethral valve ablation and severe bladder dysfunction with a mean age of @ months were studied .


Cases were further randomized into two groups .


Group I ( study group ) had endoscopic injection of a single dose of @ IU of Botox into the hypertrophied bladder neck at @ , @ , and @ o'clock .


Group II ( control group ) patients with the same parameters had urethroscopy to exclude residual valves .


Both groups had the standard conservative treatment .


Cases were followed after @ months of initiating the management protocol .


This includes laboratory studies ( urine culture and sensitivity , blood urea nitrogen , serum creatinine ) , ultrasound of the urinary tract .


Voiding cysto-urethrogram and urodynamic study ( pressure flow study ) .


There was no statistical difference in both groups regarding rate of urinary tract infection , improvement of hydronephrosis , resolution of vesico-ureteral reflux , creatinine level at the start or at the end of the study .


Urodynamic parameters revealed an increase in cystometric capacity in both groups at the end of the study but without statistical difference .


The mean voiding pressure reduced significantly in both groups but without statistical difference .


Temporarily abolishing the effect of bladder neck by Botox injection does not seem to improve the outcome of those boys who had a severe voiding dysfunction after valve ablation .


Heart rate variability ( HRV ) is reduced in stable ischemic heart disease ( SIHD ) patients and is associated with sudden cardiac death ( SCD ) .


We evaluated the impact of traditional acupuncture ( TA ) on cardiac autonomic function measured by HRV in SIHD patients .


We conducted a randomized controlled study of TA , sham acupuncture ( SA ) , and waiting control ( WC ) in @ SIHD subjects .


The TA group received needle insertion at acupuncture sites , the SA group received a sham at non-acupuncture sites , while the WC group received nothing .


The TA and SA groups received @ treatments/week for @ weeks .


@-Hour , mental arithmetic stress , and cold pressor ( COP ) HRV was collected at entry and exit , along with BP , lipids , insulin resistance , hs-CRP , salivary cortisol , peripheral endothelial function by tonometry ( PAT ) , and psychosocial variables .


Mean age was @ @ ; @ % had prior myocardial infarction .


Comparison of WC and SA groups demonstrated differences consistent with the unblinded WC status ; therefore by design , the control groups were not merged .


Exit mental stress HRV was higher in TA vs. SA for markers of parasympathetic tone ( p @ ) , including a @ % higher vagal activity ( p = @ ) .


There were no differences in exit @-hour or COP HRV , BP , lipids , insulin resistance , hs-CRP , salivary cortisol , PAT , or psychosocial variables .


TA results in intermediate effects on autonomic function in SIHD patients .


TA effect on HRV may be clinically relevant and should be explored further .


These data document feasibility and provide sample size estimation for a clinical trial of TA in SIHD patients for the prevention of SCD .


We conducted a randomized , single-blind trial of traditional acupuncture ( TA ) vs. sham acupuncture ( SA ) vs waiting control ( WC ) in stable ischemic heart disease ( SIHD ) patients to evaluate cardiac autonomic function measured by heart rate variability ( HRV ) .


Exit mental stress HRV was higher in the TA compared to SA group for time and frequency domain markers of parasympathetic tone ( all p @ ) , including a @ % higher vagal activity ( p = @ ) .


These data document feasibility and provide sample size estimation for an outcome-based clinical trial of TA in SIHD patients for the prevention of sudden cardiac death .


To evaluate the impact of nocturia on the therapeutic response of chronic insomnia to behavioral treatment in older adults .


Secondary analysis of a randomized clinical trial designed to assess the efficacy of brief behavioral treatment of insomnia ( BBTI ) vs. an information-only control ( IC ) in @ community-dwelling older adults with chronic insomnia .


For the current analysis , participants were stratified into @ groups : those with self-reported nocturia at baseline i.e. , @ void/night ( N = @ ; @ IC , @ BBTI ) and those without nocturia ( N = @ ; @ IC , @ BBTI ) .


We then determined the impact of BBTI on sleep , sleep quality , and nocturia as assessed by self-report , actigraphy , and polysomnography .


Individuals without baseline nocturia responded well to BBTI with significant decrease in sleep latency , wake after sleep onset , and total sleep time assessed by sleep diary and actigraphy ; these changes were significantly greater than those in the IC group .


In comparison , changes in the same sleep parameters among participants with nocturia were not significantly different from the IC control .


Although BBTI showed significant improvement in sleep quality in groups with and without nocturia ( as assessed by PSQI and sleep diary ) , the effect size of these improvements was larger in those without nocturia than in those with nocturia ( PSQI d = @ vs. @ , diary sleep quality d = @ vs. @ ) .


These secondary analyses suggest that brief behavioral treatment of insomnia may be more efficacious in improving insomnia in participants without nocturia .


Addressing nocturia may improve the efficacy of behavioral insomnia treatment .


To assess the effectiveness of a weighted-blanket intervention in treating severe sleep problems in children with autism spectrum disorder ( ASD ) .


This phase III trial was a randomized , placebo-controlled crossover design .


Participants were aged between @ years and @ years @ months , with a confirmed ASD diagnosis and severe sleep problems , refractory to community-based interventions .


The interventions were either a commercially available weighted blanket or otherwise identical usual weight blanket ( control ) , introduced at bedtime ; each was used for a @-week period before crossover to the other blanket .


Primary outcome was total sleep time ( TST ) recorded by actigraphy over each @-week period .


Secondary outcomes included actigraphically recorded sleep-onset latency , sleep efficiency , assessments of child behavior , family functioning , and adverse events .


Sleep was also measured by using parent-report diaries .


Seventy-three children were randomized and analysis conducted on @ children who completed the study .


Using objective measures , the weighted blanket , compared with the control blanket , did not increase TST as measured by actigraphy and adjusted for baseline TST .


There were no group differences in any other objective or subjective measure of sleep , including behavioral outcomes .


On subjective preference measures , parents and children favored the weighted blanket .


The use of a weighted blanket did not help children with ASD sleep for a longer period of time , fall asleep significantly faster , or wake less often .


However , the weighted blanket was favored by children and parents , and blankets were well tolerated over this period .


In a subset of children with unilateral Cerebral Palsy ( CP ) a discrepancy between capacity and performance of the affected upper limb can be observed .


This discrepancy is known as Developmental Disregard ( DD ) .


Though the phenomenon of DD has been well documented , its underlying cause is still under debate .


DD has originally been explained based on principles of operant conditioning .


Alternatively , it has been proposed that DD results from a diminished automaticity of movements , resulting in an increased cognitive load when using the affected hand .


To investigate the amount of involved cognitive load we studied Event-Related Potentials ( ERPs ) preceding task-related motor responses during a single-hand capacity and a dual-hand performance task .


It was hypothesised that children with DD show alterations related to long-latency ERP components when selecting a response with the affected upper limb , reflecting increased cognitive load in order to generate an adequate response and especially so within the dual-hand task .


Fifteen children with unilateral CP participated in the study .


One of the participants was excluded due to major visual impairments .


Seven of the remaining participants displayed DD .


The other seven children served as a control group .


All participants performed two versions of a cue-target paradigm , a single-hand capacity and a dual-hand performance task .


The ERP components linked to target presentation were inspected : the mid-latency P@ component and the consecutive long-latency N@b component .


In the dual-hand performance task children with DD showed an enhancement in mean amplitude of the long-latency N@b component when selecting a response with their affected hand .


No differences were found regarding the amplitude of the mid-latency P@ component .


No differences were observed regarding the single-hand capacity task .


The control group did not display any differences in ERPs linked to target evaluation processes between both hands .


These electrophysiological findings show that DD is associated with increased cognitive load when movements are prepared with the affected hand during a dual-hand performance task .


These findings confirm behavioural observations , advance our insights on the neural substrate of DD and have implications for therapy .


Patients with Parkinson 's disease ( PD ) are at high risk for cognitive dysfunction .


Non-pharmacological interventions have attracted increasing interest for enhancing PD patients ' cognitive functions .


One-year follow-up data ( T@ ) of a randomized controlled trial evaluating two @-week cognitive trainings - a structured ( NEUROvitalis , NV ) and an unstructured ( mentally fit , MF ) program - compared with a waiting list control group ( CG ) in non-demented PD patients ( Hoehn and Yahr I-III ) are presented .


Forty-seven PD patients were examined at T@ .


Effects on overall cognitive functions ( Mini-Mental State Examination and DemTect ) were compared between all groups with repeated measurement analyses of variance .


A combined score of the percentage change value from baseline ( T@ ) to T@ was calculated to identify patients who retained or improved their cognitive state ( responders ) .


The risk of developing mild cognitive impairment ( MCI ) was analyzed .


Significant time treatment effects on overall cognitive functions were found for both training groups , each compared separately to the CG ( DemTect , P < @ ) .


Nine patients ( @ % ) of the NV group , seven ( @ % ) of the MF group and three ( @ % ) of the CG were responders .


Comparing NV to CG the odds ratio was @ -LSB- @ % confidence interval ( @ ; @ ) -RSB- , and comparing MF to CG it was @ -LSB- @ % confidence interval ( @ ; @ ) -RSB- .


MCI risk for patients without prior MCI was @ % in CG , @ % in MF and @ % in NV .


The odds ratio was @ comparing NV to CG , MF to CG .


This study gives evidence that cognitive training may be effective to prevent cognitive decline and onset of MCI in PD patients .


The extended-release formulation of quetiapine ( quetiapine XR ) , which was developed to provide more convenient once-daily administration , has been widely studied to characterize its pharmacokinetics in Caucasian populations but has rarely been studied in an Asia population .


This study was conducted to evaluate the pharmacokinetics and tolerability of quetiapine XR administered as a single dose ( @ mg ) and multiple doses ( @ , @ , and @ mg ) in Han Chinese patients with schizophrenia .


This was a single-center , open-label , single-dose and multiple-dose randomized study .


Among the @ randomized subjects , a total of @ female or male patients in @ mg ( n = @ ) , @ mg ( n = @ ) , or @ mg ( n = @ ) groups completed the study of quetiapine fumarate XR .


The treatment phase consisted of @ consecutive days and was preceded by a @ - to @-day titration period for the @ and @ mg groups .


Pharmacokinetic parameters for both quetiapine and N-desalkyl quetiapine ( norquetiapine ) were determined .


The tolerability evaluation included adverse events ( AEs ) noted by monitoring , physical examinations , vital signs , and clinical laboratory tests .


N-desalkyl quetiapine was formed from quetiapine with an approximate metabolite to parent ratio of @ across the three dose groups .


The geometric mean elimination half-life ( t ) of both quetiapine and N-desalkyl quetiapine was consistent for the three dosing groups ( approximately @ h for quetiapine and approximately @ h for N-desalkyl quetiapine ) .


The geometric mean maximum plasma concentrations ( C max ) at steady state ( C max , ss ) of quetiapine for the three groups were @ , @ , and @,@ ng/mL , respectively , and for N-desalkyl quetiapine were @ , @ , and @ ng/mL , respectively .


The values for the geometric mean area under the plasma concentration-time curve over a dosing interval at the steady-state ( AUCss ) of quetiapine were @,@ , @,@ , and @,@ ngh/mL , respectively , and for N-desalkyl quetiapine were @,@ , @,@ , and @,@ ngh/mL , respectively .


The apparent oral clearance ( CL/F ) of quetiapine at steady state appeared to be comparable across the three dose groups .


The pharmacokinetics of quetiapine XR were dose-proportional across the dosage range employed .


The most common AE was somnolence , but all of the reported AEs were mild .


There were no serious AEs or other significant AEs .


Quetiapine fumarate XR has a dose-proportional pharmacokinetic profile at doses ranging from @ to @ mg once daily , and a slower time to reach C max and steady state after @ days of sequential dosing .


Therefore , it offers a simple and rapid dose-escalation option and more convenient once-daily administration .


The three dosages of quetiapine fumarate XR were generally well-tolerated in this pharmacokinetic study of Han Chinese patients with schizophrenia .


Although low-fluence @-nm Q-switched Nd : YAG laser ( QSNYL ) is widely used for the treatment of melasma , multiple treatments are necessary for clinical improvement .


Superficial chemical peeling using Jessner 's solution has been used for treatment of melasma conventionally .


To evaluate the additional therapeutic effect and adverse effects of Jessner 's peel when combined with @-nm QSNYL for melasma patients in a double-blind , placebo-controlled design .


Total of @ patients were included .


Patients who received @ sessions of @-nm QSNYL plus chemical peeling with placebo ( group A ) in a two-week interval and those who received @ sessions of @-nm QSNYL plus chemical peeling with Jessner 's solution ( group B ) in a two-week interval were analyzed .


Responses were evaluated using the Melasma Area and Severity Index ( MASI ) score , physician 's global assessment ( PGA ) and subjective self-assessment .


At @ weeks , the mean MASI score decreased from @ to @ in group A and from @ to @ in group B , showing a significant difference ( p < @ ) .


But at @ weeks , there was no significant difference on reduction of MASI , self-assessment and PGA between the two groups .


No serious adverse effects were reported with the additional Jessner 's peeling .


This study suggests Jessner 's peel is a safe and effective method in the early course of treatment for melasma when combined with low-fluence @-nm Q-switched Nd : YAG laser .


To evaluate the potential body weight-lowering effects of dietary supplementation with eicosapentaenoic acid ( EPA ) and - lipoic acid separately or combined in healthy overweight/obese women following a hypocaloric diet .


This is a short-term double-blind placebo-controlled study with parallel design that lasted @ weeks .


Of the randomized participants , @ women received the allocated treatment -LSB- Control , EPA ( @ g/d ) , - lipoic acid ( @ g/d ) , and EPA + - lipoic acid ( @ g/d +@ g/d ) -RSB- , and @ volunteers completed the study .


All groups followed an energy-restricted diet of @ % less than total energy expenditure .


Body weight , anthropometric measurements , body composition , resting energy expenditure , blood pressure , serum glucose , and insulin and lipid profile , as well as leptin and ghrelin levels , were assessed at baseline and after nutritional intervention .


Body weight loss was significantly higher ( P < @ ) in those groups supplemented with - lipoic acid .


EPA supplementation significantly attenuated ( P < @ ) the decrease in leptin levels that occurs during weight loss .


Body weight loss improved lipid and glucose metabolism parameters but without significant differences between groups .


The intervention suggests that - lipoic acid supplementation alone or in combination with EPA may help to promote body weight loss in healthy overweight/obese women following energy-restricted diets .


Cross-sectional .


To preliminarily evaluate the validity of an interview-based spinal cord injury ( SCI ) neuropathic pain screening instrument .


Six university-based SCI centers in the United States .


Clinician diagnoses of neuropathic pain ( NP ) and non-neuropathic pain subtypes were collected independently of descriptions of the pain characteristics provided by the persons with SCI by using the Spinal Cord Injury Pain Instrument ( SCIPI ) ; SCIPI information and physician diagnoses for @ pain sites of which they were most confident were subsequently compared .


Four of the SCIPI items correlated significantly with the NP subtype as determined by the clinician .


The best cutoff score for identifying NP was an endorsement of two or more of these four items .


Using this cutoff , sensitivity of the SCIPI was @ % , specificity was @ % and overall diagnostic accuracy was @ % .


In this preliminary study , the SCIPI , which can be administered by a nonclinician , appears to have good sensitivity , specificity and diagnostic accuracy in a SCI population ; it may have a role as a screening tool for NP after SCI .


Further study is needed .


Stepped care is recommended and implemented as a means to organise depression treatment .


Compared with alternative systems , it is assumed to achieve equivalent clinical effects and greater efficiency .


However , no trials have examined these assumptions .


A fully powered trial of stepped care compared with intensive psychological therapy is required but a number of methodological and procedural uncertainties associated with the conduct of a large trial need to be addressed first .


STEPS ( Developing stepped care treatment for depression ) is a mixed methods study to address uncertainties associated with a large-scale evaluation of stepped care compared with high-intensity psychological therapy alone for the treatment of depression .


We will conduct a pilot randomised controlled trial with an embedded process study .


Quantitative trial data on recruitment , retention and the pathway of patients through treatment will be used to assess feasibility .


Outcome data on the effects of stepped care compared with high-intensity therapy alone will inform a sample size calculation for a definitive trial .


Qualitative interviews will be undertaken to explore what people think of our trial methods and procedures and the stepped care intervention .


A minimum of @ patients with Major Depressive Disorder will be recruited from an Improving Access to Psychological Therapies service and randomly allocated to receive stepped care or intensive psychological therapy alone .


All treatments will be delivered at clinic facilities within the University of Exeter .


Quantitative patient-related data on depressive symptoms , worry and anxiety and quality of life will be collected at baseline and @ months .


The pilot trial and interviews will be undertaken concurrently .


Quantitative and qualitative data will be analysed separately and then integrated .


The outcomes of this study will inform the design of a fully powered randomised controlled trial to evaluate the effectiveness and efficiency of stepped care .


Qualitative data on stepped care will be of immediate interest to patients , clinicians , service managers , policy makers and guideline developers .


A more informed understanding of the feasibility of a large trial will be obtained than would be possible from a purely quantitative ( or qualitative ) design .


The overuse of antimicrobials is recognized as the main selective pressure driving the emergence and spread of antimicrobial resistance in human bacterial pathogens .


Urinary tract infections ( UTIs ) are among the most common infections presented in primary care and empirical antimicrobial treatment is currently recommended .


Previous research has identified that a substantial proportion of Irish general practitioners ( GPs ) prescribe antimicrobials for UTIs that are not in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland .


The aim of this trial is to design , implement and evaluate the effectiveness of a complex intervention on GP antimicrobial prescribing and adult ( @ years of age and over ) patients ' antimicrobial consumption when presenting with a suspected UTI .


The Supporting the Improvement and Management of Prescribing for urinary tract infections ( SIMPle ) study is a three-armed intervention with practice-level randomization .


Adult patients presenting with suspected UTIs in primary care will be included in the study.The intervention integrates components for both GPs and patients .


For GPs the intervention includes interactive workshops , audit and feedback reports and automated electronic prompts summarizing recommended first-line antimicrobial treatment and , for one intervention arm , a recommendation to consider delayed antimicrobial treatment .


For patients , multimedia applications and information leaflets are included .


Thirty practices will be recruited to the study ; laboratory data indicate that @,@ patients will be prescribed an antimicrobial in the study .


The primary outcome is a change in prescribing of first-line antimicrobials for UTIs in accordance with the Guidelines for Antimicrobial Prescribing in Primary Care in Ireland .


The study will take place over @ months with a six-month intervention period .


Data will be collected through a remote electronic anonymized data-extraction system , a text-messaging system and GP and patient interviews and surveys .


The intervention will be strengthened by the implementation of a social marketing framework and an economic evaluation .


Among young children in Burkina Faso , anemia and chronic and acute undernutrition are widespread .


This study assessed the impact of Helen Keller International 's ( HKI ) @-y integrated agriculture -LSB- homestead food production ( HFP ) -RSB- and nutrition and health behavior change communication ( BCC ) program , targeted to women , on children 's ( @-@ @ mo old at baseline ) anthropometry ( stunting , wasting , and underweight ) , mean hemoglobin ( Hb ) , anemia ( Hb < @ g/dL ) , and diarrhea prevalence .


We used a cluster-randomized controlled trial , with @ villages randomly assigned to a control group ( n = @ ) or @ of @ treatment groups ( n = @ each ) , which differed by who delivered the BCC messages -LSB- older women leaders or health committee ( HC ) members -RSB- .


We used difference-in-difference ( DID ) estimates to assess impacts on child outcomes .


We found marginally significant ( P < @ ) impacts on Hb ( DID : @ g/dL ; P = @ ) and wasting -LSB- DID : -@ percentage point ( pp ) ; P = @ -RSB- and statistically significant ( P < @ ) impacts on diarrhea ( -@ pp ; P = @ ) in HC compared with control villages among children aged @-@ @ mo and larger impacts for anemia ( DID : -@ pp ; P = @ ) and mean Hb ( DID : @ g/dL ; P = @ ) among younger children ( aged @-@ @ mo ) .


However , we found no significant impacts on stunting or underweight prevalence .


Plausibility was supported by greater improvements in women 's agricultural production and maternal infant and young child feeding and care knowledge and practices in HC compared with control villages .


HKI 's @-y integrated HFP+BCC program ( HC group ) significantly improved several child outcomes , including wasting ( marginal ) , diarrhea , Hb , and anemia , especially among the youngest children .


This is the first cluster-randomized controlled trial of an HFP program that documents statistically significant positive effects on these child nutrition outcomes .


This trial was registered at clinicaltrials.gov as NCT@ .


Occipital nerve stimulation ( ONS ) may provide pain relief in migraine patients .


In this double-blinded trial we investigated the significance of paresthesia and possible placebo effects .


Patients already treated with ONS reporting stable treatment effect were included .


`` Effective stimulation , '' `` subthreshold stimulation '' and `` no stimulation '' were compared .


Patients cycled through all three treatment groups .


Outcome was measured using the visual analog scale ( VAS ) for pain , McGill Pain Questionnaire and SF-@ .


Eight patients were included , mean preoperative VAS was @ @ .


A significant improvement in pain was observed in favor of suprathreshold stimulation compared to subthreshold stimulation ( @ @ vs @ @ ) .


Pain also significantly improved under subthreshold stimulation compared to no stimulation ( @ @ vs @ @ ) .


No changes in SF-@ were observed .


Paresthesia is not required to achieve pain reduction but suprathreshold stimulation yields better results , underlining the significance of stimulation parameter customization .


To determine the relationship between delayed patchy choroidal filling and morphologic and functional outcomes among eyes treated with ranibizumab or bevacizumab .


Cohort study .


Comparison of Age-related Macular Degeneration Treatment Trials participants were assigned randomly to ranibizumab or bevacizumab on a monthly or as-needed schedule .


Presence of delayed patchy choroidal filling and morphologic and functional outcomes were evaluated among eyes with gradable fluorescein angiography at baseline ( n = @ ) and at @ year ( n = @ ) eyes .


Delayed filling was present in @ ( @ % ) of @ eyes at baseline .


Eyes with incident delayed filling at @ year ( @ -LSB- @ % -RSB- of @ ) showed a mean decrease of @ letters in visual acuity , whereas eyes without incident delayed filling had a mean improvement of @ letters ( difference -LSB- -RSB- , -@ ; @ % confidence interval -LSB- CI -RSB- , -@ to -@ ; P < @ ) .


Eyes with incident delayed filling had a larger increase in mean total lesion area of choroidal neovascularization ( @ mm ( @ ) ) than eyes without incident delayed filling ( @ mm ( @ ) ; , @ ; @ % CI , @ to @ ; P = @ ) .


The proportion with incident delayed filling at @ year was similar among eyes treated with ranibizumab ( @ -LSB- @ % -RSB- of @ ) or bevacizumab ( @ -LSB- @ % -RSB- of @ ; P = @ ) and among eyes treated monthly ( @ -LSB- @ % -RSB- of @ ) or as needed ( @ -LSB- @ % -RSB- of @ ; P = @ ) .


Delayed patchy choroidal filling was uncommon at baseline .


Although only a small percentage of eyes demonstrated delayed filling during the first year of anti-vascular endothelial growth factor treatment , these eyes had worse visual acuity and a larger increase in total lesion area of choroidal neovascularization .


AVI-@ is a phosphorodiamidate morpholino oligomer with positive charges that targets the viral messenger RNA that encodes Marburg virus ( MARV ) nucleoprotein .


Its safety in humans is undetermined .


We assessed the efficacy of AVI-@ in a series of studies involving a lethal challenge with MARV in nonhuman primates .


The safety of AVI-@ was evaluated in a randomized , multiple-ascending-dose study in which @ healthy humans ( @ humans per dose group ) received @ once-daily infusions of AVI-@ ( @ mg , @ mg , @ mg , @ mg , or @ mg per kilogram of body weight ) or placebo , in a @:@ ratio .


We estimated the protective dose in humans by comparing pharmacokinetic variables in infected nonhuman primates , uninfected nonhuman primates , and uninfected humans .


Survival in infected nonhuman primates was dose-dependent , with survival rates of @ % , @ % , @ % , @ % , @ % , and @ % among monkeys treated with @ mg , @ mg , @ mg , @ mg , @ mg , and @ mg of AVI-@ per kilogram , respectively ( P < @ with the use of the log-rank test for the comparison of survival across groups ) .


No safety concern was identified at doses up to @ mg per kilogram per day in humans .


No serious adverse events were reported .


Drug exposure ( the area under the curve ) was dose-dependent in both nonhuman primates and humans ; drug clearance was independent of dose but was higher in nonhuman primates than in humans .


The protective dose in humans was initially estimated , on the basis of exposure , to be @ mg per kilogram per day ( @ % confidence interval , @ to @ ) for @ days .


Monte Carlo simulations supported a dose of @ mg per kilogram per day to match the geometric mean protective exposure in nonhuman primates .


This study shows that , on the basis of efficacy in nonhuman primates and pharmacokinetic data in humans , AVI-@ has potential as postexposure prophylaxis for MARV infection in humans .


( Funded by the Department of Defense ; ClinicalTrials.gov number , NCT@ . )


Better understanding of the circumstances of alcohol-related adverse events experienced by university students could identify opportunities for prevention .


We aimed to identify situational and contextual factors associated with unintentional injury , assault , unsafe sex , sexual assault and drink-driving/riding amongst university students .


We conducted a Web-based survey of full-time students aged @-@ years at five New Zealand universities ( n = @ ) and carried out between - and within-subjects comparisons ( case-control and case-crossover , respectively ) of situational and contextual characteristics of events in the last seven days and control drinking occasions .


The response fraction was @ % .


For the seven days preceding the survey , @ % of women and @ % of men reported at least one of the defined events while they were drinking or soon after .


The number of drinking locations and getting drunker than expected were strongly associated with risk of an event in both case-control and case-crossover models , independent of consumption .


Total number of drinks , drinking later and into the morning , and drinking with close friends were also associated with increased risk in the case-control analysis .


No gender difference was seen after controlling for drinking and contextual factors .


Strategies to reduce the duration and volume of alcohol consumption , including earlier closing of licensed premises , should be considered as countermeasures for alcohol-related adverse events .


The use of two different comparison groups for the circumstances of adverse events when drinking can strengthen inferences about the contribution of contextual factors .


While the @-adrenoceptor pathway is essential for cardiovascular regulation , the impact of ADRB@ gene variations on circulatory responses is unclear , possibly due to neural compensatory mechanisms .


We tested the hypotheses that ( i ) sympathetic block by thoracic epidural anaesthesia ( TEA ) unmasks the influence on arterial pressure of genetic variations and ( ii ) vasopressor requirements during TEA depend on ADRB@ gene variation .


Ninety-three elective patients undergoing abdominal surgery were included prospectively .


After epidural bupivacaine @ % ( @ mg test dose +@ mg ) , arterial pressure , heart rate , and progression of sensory block were measured for @ min in the supine awake state and for @ min after standardized anaesthetic induction of general anaesthesia .


The primary endpoint was cumulative dose of the - adrenoreceptor agonist phenylephrine administered to sustain a mean arterial pressure > @ mm Hg .


The ADRB@ polymorphisms Arg@Gly and Gln@Glu were genotyped using Slowdown-PCR .


After TEA , @ ( @ % ) patients required phenylephrine .


The mean dosages ( sd ) were significantly different between the ADRB@ genotypes -LSB- Arg@Arg @ g ( @ ) , Arg@Gly @ g ( @ ) , Gly@Gly @ g ( @ ) , P = @ ; Gln@Gln @ g ( @ ) , Gln@Glu @ g ( @ ) , Glu@Glu @ g ( @ ) , P = @ -RSB- .


Multiple linear regression analysis revealed that age , male gender , rostral extent of sensory block , lower arterial pressure before TEA , and ADRB@ Glu@ allele together explained @ % of phenylephrine dosage variation , with genetic variants being the second most important predictor ( @ % ; P < @ ) .


The ADRB@ Glu@ allele is an independent predictor of arterial hypotension and vasopressor requirements after TEA .


Neural block can unmask genetic influences on neurohumoral regulation .


Clinical trial registration DRKS@ .


Patient-centered models of assessment have shown considerable promise for increasing patients ' readiness for mental health treatment in general , but have not been used to facilitate patients ' engagement in substance use disorder ( SUD ) treatment .


We developed a brief patient-centered intervention using assessment and feedback of personality data and examined its acceptability and efficacy to increase early engagement in residential SUD treatment .


Thirty patients entering a @-day residential SUD treatment program were randomly assigned to a feedback ( n = @ ) or control ( n = @ ; assessment-only ) condition .


Normal-range personality was assessed with the NEO Personality Inventory-Revised ( NEO PI-R ) .


Patients were re-interviewed one month after treatment entry to obtain information on their satisfaction with the intervention , as well as their adjustment to the residential milieu .


Electronic medical records were reviewed to obtain information on patients ' length of stay in the program and discharge status .


Univariate ANOVAs and chi-square tests were conducted to examine group differences on outcomes .


Patients ' ratings indicated strong satisfaction with the feedback intervention and expectations that it would have a positive impact on their treatment experiences .


Among patients who had not previously been treated in the residential program , the feedback intervention was associated with more positive relationships with other residents in treatment and a stronger alliance with the treatment program one month after treatment entry .


The feedback intervention was also associated with a longer length of stay in treatment , although this effect did not reach statistical significance .


The findings highlight the clinical utility of providing SUD patients with patient-centered feedback based on the results of personality testing , and provide preliminary support for the acceptability and efficacy of this intervention to facilitate early engagement in residential SUD treatment .


In children with single right ventricular ( RV ) anomalies , changes in RV size and function may beinfluenced by shunt type chosen at the time of the Norwood procedure .


The study sought to identify shunt-related differences in echocardiographic findings at @ months and@months pre-Fontan in survivors of the Norwood procedure .


We compared @-dimensional and Doppler echocardiographic indices of RV size and function , neo-aortic and tricuspid valve annulus dimensions and function , and aortic size and patency at @ @ months and @ @ months in subjects randomized to a Norwood procedure using either the modified Blalock-Taussig shunt ( MBTS ) or right ventricle to pulmonary artery shunt ( RVPAS ) .


Acceptable echocardiograms were available at both time points in @ subjects ( @ MBTS , @ RVPAS ) .


At @ months , all indices were similar between shunt groups .


From the @-month to pre-Fontan echocardiogram , the MBTS group had stable indexed RV volumes and ejection fraction , while the RVPAS group had increased RV end-systolic volume ( p = @ ) and decreased right ventricular ejection fraction ( RVEF ) ( p = @ ) .


From @ months to pre-Fontan , the treatment groups were similar with respect to decline in indexed neo-aortic valve area , > mild neo-aortic valve regurgitation ( < @ % at each time ) , indexed tricuspid valve area , andmoderate tricuspid valve regurgitation ( < @ % at each time ) .


Initial Norwood shunt type influences pre-Fontan RV remodeling during the second and third years of life in survivors with single RV anomalies , with greater RVEF deterioration after RVPAS .


Encouragingly , other indices of RV function remain stable before Fontan regardless of shunt type .


( Comparison of Two Types of Shunts in Infants with Single Ventricle Defect Undergoing Staged Reconstruction-Pediatric Heart Network ; NCT@ ) .


The aim of the study was to compare Cistiquer , a new phytotherapeutic product developed for chronic bladder inflammatory diseases , and intra-vesical administration of gentamicin plus betametasone , in females with urethral syndrome .


Between september @ and may @ , @ women with urethral syndrome and trigonitis were incuded in this study .


Patients were randomly assigned to treatment with intra-vesical administration of betametasone @ mg plus gentamicin @ mg ( group A ) , and oral administration of Cistiquer ( group B ) for @ weeks .


Before and after the therapeutic protocol , symptoms were assessed by three days voiding diary , the overactive bladder questionnaire short form and a ten points visual analogic scale adopted to assess the micturition discomfort .


Histologic findings were assessed by the examination of specimens obtained by cold bladder biopsies of the bladder trigone at baseline in all the subjects .


The two groups had significant and comparable symptoms improvement .


However , the score obtained from the visual analogic scale decreased significantly only in the group submitted to oral therapy .


Furthermore , in the group treated with endovesical approach , higher drop out rate and higher incidence of urinary infection were observed .


Patients with urethral syndrome and trigonitis improved symptoms either with oral therapy with Cistiquer and with intra-vesical administration of gentamicin plus betametasone .


However , treatment adherence resulted higher for patients treated by oral therapy and rate of adverse events resulted higher for those submitted to endovesical treatment .


To evaluate the cardiorespiratory , sedative and antinociceptive effects of dexmedetomidine alone or in combination with methadone , morphine or tramadol in dogs .


Experimental , blinded , randomized , crossover study .


Six mixed breed dogs ( two males and four females ) weighing @ @ kg .


The animals were randomly divided into four treatments : D ( @ g kg ( -@ ) of dexmedetomidine ) , DM ( dexmedetomidine @ g kg ( -@ ) and methadone @ mg kg ( -@ ) ) ; DMO ( dexmedetomidine @ g kg ( -@ ) and morphine @ mg kg ( -@ ) ) , and DT ( dexmedetomidine @ g kg ( -@ ) and tramadol @ mg kg ( -@ ) ) .


The combinations were administered intramuscularly in all treatments .


The variables evaluated were heart rate ( HR ) , respiratory rate ( f ( R ) ) , rectal temperature ( RT ) , systolic arterial pressure ( SAP ) , sedation scale and pedal withdrawal reflex .


These variables were measured at T@ ( immediately before the administration of the protocol ) and every @ minutes thereafter until T@ .


A decrease in HR and f ( R ) occurred in all the treatments compared with T@ , but no significant difference was observed between the treatments .


The RT decreased from T@ onward in all the treatments .


The SAP did not show a difference between the treatments , but in the DT treatment , the SAP was lower at T@ and T@ compared with T@ .


The D treatment had lower scores of sedation at T@ to T@ compared with the other treatments , and the DMO and DM treatments showed higher scores at T@ and T@ compared with DT .


The treatments with morphine and methadone added to the dexmedetomidine showed higher sedation scores than the control treatment and the treatment with tramadol added to the dexmedetomidine showed no relevant differences in any of the variables evaluated in the study .


This study was conducted to examine the effects of aerobic exercise training on psychosocial aspects ( mental health , the aspects of physical symptoms , anxiety and insomnia , social functioning , and depression ) in patients with type @ diabetes mellitus .


@ men who had type @ diabetes mellitus for a mean duration of the disease for @ years were selected purposely and classified randomly into experimental ( @ patients ) and a control group ( @ patients ) .


Patients in the experimental group did aerobic exercise training three times a week for eight weeks .


The exercise included an aerobic activity for @ to @ minutes during which the patients ' heart rates were maintained at @-@ percent of heart rate reserve on ergo meter bikes .


The eight-week aerobic exercise training had significant effects on mental health ( p = @ ) , subscales of physical symptoms ( p = @ ) , and anxiety and insomnia ( p = @ ) .


It had no significant effects on subscales related to disorder of social functioning ( p = @ ) and depression ( p = @ ) .


Aerobic exercise training can be considered as an appropriate program for improving the health of the patients with type @ diabetes mellitus , and it also can improve their mental health .


The Whitehall II ( WHII ) study of British civil servants provides a unique source of longitudinal data to investigate key factors hypothesized to affect brain health and cognitive ageing .


This paper introduces the multi-modal magnetic resonance imaging ( MRI ) protocol and cognitive assessment designed to investigate brain health in a random sample of @ members of the WHII study .


A total of @ civil servants participated in the WHII Phase @ clinical examination in @-@ .


A random sample of these participants was included in a sub-study comprising an MRI brain scan , a detailed clinical and cognitive assessment , and collection of blood and buccal mucosal samples for the characterisation of immune function and associated measures .


Data collection for this sub-study started in @ and will be completed by @ .


The participants , for whom social and health records have been collected since @ , were between @-@ years of age at the time the MRI study started .


Here , we describe the pre-specified clinical and cognitive assessment protocols , the state-of-the-art MRI sequences and latest pipelines for analyses of this sub-study .


The integration of cutting-edge MRI techniques , clinical and cognitive tests in combination with retrospective data on social , behavioural and biological variables during the preceding @years from a well-established longitudinal epidemiological study ( WHII cohort ) will provide a unique opportunity to examine brain structure and function in relation to age-related diseases and the modifiable and non-modifiable factors affecting resilience against and vulnerability to adverse brain changes .


Results from the National Lung Cancer Audit demonstrate unexplained variation in outcomes .


Peer review with supported quality improvement has been shown to reduce variation in other areas of health care but has not been formally tested in cancer multidisciplinary teams .


The aim of the current study is to assess the impact of reciprocal peer-to-peer review visits with supported quality improvement and collaborative working on lung cancer process and outcome measures .


English lung cancer teams were randomised to usual care or facilitated reciprocal peer review visits followed by @ months of supported quality improvement .


The primary outcome was change in the following national audit indicators ; mulitdisciplinary team discussion , histological confirmation , active treatment , surgical resection , small-cell chemotherapy and specialist nurse review .


Patient experience was measured using a new lung cancer patient questionnaire in the intervention group .


Thirty teams ( @ trusts ) entered the intervention group and @ of these submitted a total of @ quality improvement plans .


Active treatment increased in the intervention group ( n = @ ) by @ % compared with @ % in the control group ( n = @ , mean difference @ % , @ % CI -@ to @ % , P = @ ) .


The remaining audit indicators improved similarly in all groups .


Mean patient experience scores in the intervention group did not change significantly during the study but a significant improvement was seen in the scores for the five teams with the worst baseline scores ( @ to @ , P < @ ) .


Reciprocal peer review with supported quality improvement was feasible and effective in stimulating quality improvement activity but resulted in only modest improvements in lung cancer treatment rates and patient experience .


Chronic fatigue syndrome or myalgic encephalomyelitis ( CFS/ME ) is a relatively common and potentially serious condition with a limited evidence base for treatment .


Specialist treatment for paediatric CFS/ME uses interventions recommended by National Institute for Health and Clinical Excellence ( NICE ) including cognitive behavioural therapy , graded exercise therapy and activity management .


The Lightning Process ( LP ) is a trademarked intervention derived from osteopathy , life-coaching and neuro-linguistic programming , delivered over three consecutive days as group sessions .


Although over @ children with CFS/ME attend LP courses each year , there are no reported studies on the effectiveness or cost-effectiveness .


This pragmatic randomised controlled trial is set within a specialist paediatric CFS/ME service in the south west of England .


Children and young people with CFS/ME ( n = @ to @ ) , aged @ to @ years old will be randomised to specialist medical care ( SMC ) or SMC plus the LP .


The primary outcome will be physical function ( SF-@ physical function short form ) and fatigue ( Chalder Fatigue Scale ) .


This study will tell us whether adding the LP to SMC is effective and cost-effective compared to SMC alone .


This study will also provide detailed information on the implementation of the LP and SMC .


The study was designed to evaluate the effectiveness of the combination of chemonucleolysis and psoas compartment block ( PCB ) for the treatment of lumbar disc herniations ( LDHs ) and to explore the role of PCB in managing postoperative pain of collagenase injection .


Two groups of patients ( N = @ ) were treated in different ways , respectively .


Group A ( N = @ ) was treated with chemonucleolysis only ( the injection of oxygen-ozone combined with collagenase into the lumbar disc and the epidural space ) ; group B ( N = @ ) was treated with chemonucleolysis and PCB .


After the treatment , the patients were followed-up , and the therapeutic effect was assessed at @ week , @ month , @ months , and @ months by the relative pain reduction , visual analog scale ( VAS ) pain scores , and the Oswestry Disability Index ( ODI ) scores .


In group A , treatment success rate was @ % ( @ of @ ) , @ % ( @ of @ ) , @ % ( @ of @ ) , and @ % ( @ of @ ) at @ week , @ month , @ months , and @ months , respectively .


In group B , treatment success rate was @ % ( @ of @ ) , @ % ( @ of @ ) , @ % ( @ of @ ) , and @ % ( @ of @ ) at @ week , @ month , @ months , and @ months , respectively .


There was statistically significant difference in outcome between two groups at @ week , but there were no statistically significant difference in outcome between two groups at @ month , @ months , and @ months .


VAS scores and ODI were significantly decreased in both group A and group B , when compared with the baseline values in the same group at all points of follow-up .


Group B produced a significant reduction in the VAS scores and ODI when compared with group A at : @-week , @-month , @-month , @-month follow-up .


Computer tomography ( CT ) - guided chemonucleolysis combined with PCB leads to rapid pain relief , fewer postoperative pain of collagenase injection happen , and should be regarded as a useful treatment for the management of LDH .


To identify patient and caregiver characteristics associated with caregiver dissatisfaction with hospital care of cognitively impaired elderly adults .


Secondary analysis of data from a randomized controlled trial .


An @,@-bed general hospital in England providing the only emergency medical services in its area .


Cognitively impaired individuals aged @ and older randomly assigned to a specialist unit or standard geriatric or internal medical wards ( N = @ ) and related caregivers ( N = @ ) .


Patient and caregiver health status was measured at baseline , including delirium , cognitive impairment , behavioral and psychological symptoms , activities of daily living , and caregiver strain .


Caregiver satisfaction with quality of care was ascertained after hospital discharge or death .


Four hundred sixty-two caregivers completed satisfaction questionnaires .


Regardless of assignment , @ % of caregivers were dissatisfied with some aspects of care , but overall @ % were satisfied with care .


The main areas of dissatisfaction were communication , discharge planning , and medical management .


Dissatisfaction was associated with high levels of patient behavioral and psychological symptoms on admission , caregiver strain and poor psychological well-being at admission , a diagnosis of delirium , and the relationship between the caregiver and the patient .


There was less dissatisfaction from caregivers of patients managed on the specialist Medical and Mental Health Unit than those on standard wards , after controlling for multiple factors .


Dissatisfaction was associated with patient behavioral and psychological symptoms and caregiver strain but was not immutable to efforts to improve care .


Statins , or @-hydroxy-@-methylglutaryl coenzyme A ( HMG-CoA ) reductase inhibitors , have anti-inflammatory effects that are independent of their lipid-lowering properties .


Despite suppressive antiretroviral therapy ( ART ) , elevated levels of immune activation and inflammation often persist .


The Stopping Atherosclerosis and Treating Unhealthy Bone With Rosuvastatin in HIV ( SATURN-HIV ) trial is a randomized , double-blind , placebo-controlled study , designed to investigate the effects of rosuvastatin ( @ mg/daily ) on markers of cardiovascular disease risk in ART-treated human immunodeficiency virus ( HIV ) - infected subjects .


A preplanned analysis was to assess changes in markers of immune activation at week @ .


Subjects with low-density lipoprotein cholesterol < @ mg/dL and heightened immune activation ( % CD@ ( + ) CD@ ( + ) HLA-DR ( + ) @ % , or plasma high-sensitivity C-reactive protein @ mg/L ) were randomized to receive rosuvastatin or placebo .


We measured plasma ( soluble CD@ and CD@ ) and cellular markers of monocyte activation ( proportions of monocyte subsets and tissue factor expression ) and T-cell activation ( expression of CD@ , HLA-DR , and PD@ ) .


After @ weeks of rosuvastatin , we found significant decreases in plasma levels of soluble CD@ ( -@ % vs @ % , P = @ ) and in proportions of tissue factor-positive patrolling ( CD@ ( Dim ) CD@ ( + ) ) monocytes ( -@ % vs -@ % , P = @ ) in rosuvastatin-treated vs placebo-treated subjects .


These findings were independent of the lipid-lowering effect and the use of protease inhibitors .


Rosuvastatin did not lead to any changes in levels of T-cell activation .


Rosuvastatin treatment effectively lowered markers of monocyte activation in HIV-infected subjects on antiretroviral therapy .


To compare the efficacy of an anhydrous dentifrice containing @ % w/w stannous fluoride and a negative control dentifrice containing @,@ ppm fluoride , as sodium monofluorophosphate , at reducing dentin hypersensitivity over @ weeks with twice-daily brushing .


This was a randomized , examiner-blind , parallel , two treatment group , stratified ( by maximum baseline Schiff sensitivity score ) , @-week clinical study carried out at a single site in @ healthy subjects with at least two sensitive teeth , who met all study criteria at the screening and baseline visits .


Clinical assessments of sensitivity to evaporative ( air ) -LSB- with Schiff sensitivity score and visual analogue scale ( VAS ) -RSB- and tactile ( Yeaple probe ) stimuli were employed to compare the efficacy of the test dentifrice containing @ % w/w stannous fluoride to the negative control dentifrice at reducing sensitivity after @ and @ weeks treatment .


Of the @ subjects randomized to study treatment , @ completed the study .


At @ and @ weeks , between treatment analyses found the test dentifrice to be significantly better than the negative control dentifrice in relieving dentin hypersensitivity for all measures ( Schiff : P < @ at @ and @ weeks ; VAS score : P = @ at @ weeks , P < @ at @ weeks ; tactile threshold : P = @ at @ weeks , P < @ at @ weeks ) .


To discuss the influence of mifepristone to caspase @ expression in adenomyosis tissue .


Sixty patients were equally divided into four groups .


Groups @ , @ , and @ were treated with @ , @ , and @ mg mifepristone , respectively and group @ was treated with placebo .


The expression of caspase @ was examined by immunohistochemical method in both eutopic and ectopic endometria of the @ cases .


Compared with placebo group , the expression of caspase @ in both eutopic endometrium and ectopic endometrium in the three treatment groups was significantly increased .


There was no difference in the expression of caspase @ in both eutopic and ectopic endometria between the ten and @ mg treatment groups , while both the ten and @ mg treatment groups had a higher expression intensity of caspase @ in both eutopic and ectopic endometria , compared with the five mg treatment group ( p < @ ) .


Mifepristone can increase the expression of caspase @ in both eutopic and ectopic endometria and initiate cell apoptosis in both eutopic and ectopic endometria .


Therefore mifepristone can effectively inhibit the emergence and development of adenomyosis .


The aim of this study was to evaluate the efficacy and safety of intralesional bevacizumab , a monoclonal antibody against vascular endothelial growth factor , in patients with human immunodeficiency virus ( HIV ) - associated Kaposi 's sarcoma of the upper airway receiving antiretroviral therapy .


A pilot randomized , open , phase II study .


HIV-infected patients with Kaposi 's sarcoma lesions of the upper airway in the T@ stage were randomized to receive antiretroviral therapy alone or antiretroviral therapy with intralesional bevacizumab .


The primary end point was the assessment of changes in tumor size according to the Response Evaluation Criteria In Solid Tumors ( RECIST ) ; the secondary end point was safety .


Of the @ patients with Kaposi 's sarcoma included in the study , seven were assigned to the bevacizumab group and seven to the control group .


The median age was @ years ( interquartile range -LSB- IQR -RSB- , @-@ @ ) .


Four patients ( @ % ) had > @ CD@ T cells/mm ( @ ) .


Nine patients had lesions in the oral cavity ; three patients had pharyngeal disease ; one patient had laryngeal involvement ; and one patient had oral cavity , pharyngeal , and laryngeal involvement .


Four patients had complete response ( @ % ) , two had partial response , six had stable disease , and two had progressive disease .


The median time to complete response was @ weeks ( IQR , @-@ @ ) .


No statistical differences between groups were observed ( P = @ ) .


In the bevacizumab group , one patient had a grade I adverse event , and another patient had a grade II adverse event .


Intralesional administration of bevacizumab was well tolerated but had no impact on upper respiratory tract Kaposi 's sarcoma lesions of HIV-infected patients .


U.S. state AIDS Drug Assistance Programs ( ADAPs ) are federally funded to provide antiretroviral therapy ( ART ) as the payer of last resort to eligible persons with HIV infection .


States differ regarding their financial contributions to and ways of implementing these programs , and it remains unclear how this interstate variability affects HIV treatment outcomes .


We analyzed data from HIV-infected individuals who were clinically-eligible for ART between @ and @ ( i.e. , a first reported CD@ + < @ cells/uL or AIDS-defining illness ) from @ U.S. cohorts of the North American AIDS Cohort Collaboration on Research and Design ( NA-ACCORD ) .


Using propensity score matching and Cox regression , we assessed ART initiation ( within @ months following eligibility ) and virologic suppression ( within @ year ) based on differences in two state ADAP features : the amount of state funding in annual ADAP budgets and the implementation of waiting lists .


We performed an a priori subgroup analysis in persons with a history of injection drug use ( IDU ) .


Among @,@ persons , @ % initiated ART within six months following eligibility .


Persons living in states with no additional state contribution to the ADAP budget initiated ART on a less timely basis ( hazard ratio -LSB- HR -RSB- @ , @ % CI @-@ @ ) .


Living in a state with an ADAP waiting list was not associated with less timely initiation ( HR @ , @ % CI @-@ @ ) .


Neither additional state contributions nor waiting lists were significantly associated with virologic suppression .


Persons with an IDU history initiated ART on a less timely basis ( HR @ , @ % CI @-@ @ ) .


We found that living in states that did not contribute additionally to the ADAP budget was associated with delayed ART initiation when treatment was clinically indicated .


Given the changing healthcare environment , continued assessment of the role of ADAPs and their features that facilitate prompt treatment is needed .


Randomized trials have indicated a benefit for endovascular therapy in appropriately selected stroke patients at @ months , but data regarding outcomes at @ months are currently lacking .


We compared functional and quality-of-life outcomes at @ months overall and by stroke severity in stroke patients treated with intravenous tissue-type plasminogen activator followed by endovascular treatment as compared with intravenous tissue-type plasminogen activator alone in the Interventional Management of Stroke III Trial .


The key outcome measures were a modified Rankin Scale score @ ( functional independence ) and the Euro-QoL EQ-@D , a health-related quality-of-life measure .


@ subjects with moderate-to-severe stroke ( National Institutes of Health Stroke Scale @ ) were enrolled at @ centers in the United States ( @ sites ) , Canada ( @ ) , Australia ( @ ) , and Europe ( @ ) .


There was an interaction between treatment group and stroke severity in the repeated measures analysis of modified Rankin Scale @ outcome ( P = @ ) .


In the @ participants with severe stroke ( National Institutes of Health Stroke Scale @ ) , a greater proportion of the endovascular group had a modified Rankin Scale @ ( @ % ) at @ months as compared with the intravenous tissue-type plasminogen activator group ( @ % , P = @ ) ; no difference was seen for the @ participants with moderately severe strokes ( @ % versus @ % ) .


In participants with severe stroke , the endovascular group had @ ( @ % confidence interval : @ , @ ) more quality-adjusted-days over @ months as compared with intravenous tissue-type plasminogen activator alone .


Endovascular therapy improves functional outcome and health-related quality-of-life at @ months after severe ischemic stroke .


In a recent double-blinded clinical trial , the probiotic combination of Lactobacillus acidophilus NCFM ( L-NCFM ) and B-LBi@ reduced bloating symptoms in patients with functional bowel disorders ; an effect more evident in those who reported abdominal pain .


In mice , L-NCFM but not B-LBi@ induced colonic mu-opioid receptor ( MOR ) and cannabinoid receptor @ ( CB@ ) expression , and reduced visceral sensitivity .


To determine if L-NCFM was the active component in the clinical trial and to investigate the mechanism of action in humans with mild to moderate abdominal pain .


Caucasian women ( n = @ ) @-@ years with mild to moderate abdominal pain were enrolled in a double-blind , two-armed , single-centre study .


Patients were given either L-NCFM alone or in combination with B-LBi@ for @ days at a total dose of @ @ ( @ ) CFU b.d. Colonic biopsies were collected during unsedated , unprepped flexible sigmoidoscopy before and at the end of probiotic consumption .


mRNA and immunostaining were then performed on these biopsies .


Patients kept symptom diaries for the @ days prior to starting probiotic therapy and for the last @ days of therapy .


L-NCFM alone , but not with B-LBi@ , induced colonic MOR mRNA and protein expression , as well as downstream signalling , as measured by enterocyte STAT@-phosphorylation .


In contrast , CB@ expression was decreased .


Both treatment groups trended towards improvement in symptoms , but the study was insufficiently powered to draw meaningful conclusions .


Lactobacillus acidophilus NCFM modulates mu-opioid receptor expression and activity , while the combination of L-NCFM and B-LBi@ does not .


This study provides a possible mechanism for action by which probiotics modulates pain sensation in humans ( Clinical Trial Number : NCT@ ) .


In Guinea-Bissau we conducted three trials of neonatal vitamin A supplementation ( NVAS ) from @ to @ .


None of the trials found a beneficial effect on mortality .


From @ to @ , an early measles vaccine ( MV ) trial was ongoing , randomizing children @:@ to early MV at @ months or no early MV , in addition to the usual MV at @ months .


We have previously found interactions between vitamin A and vaccines .


We investigated whether there were interactions between NVAS and early MV .


We compared the mortality of NVAS and placebo recipients : first , from @ to @ months for children randomized to early MV or no early MV ; and second , from @ to @ months in children who had received two MV or one MV .


Mortality rates ( MR ) were compared in Cox models producing mortality rate ratios ( MRR ) .


A total of @ children were randomized to NVAS ( N = @ ) or placebo ( N = @ ) and were later randomized to early MV ( N = @ ) or no early MV ( N = @ ) .


Between @ and @ months , NVAS compared with placebo was associated with higher mortality in early MV recipients ( MR = @ versus MR = @ , p = @ ) , but not in children who did not receive early MV ( p for interaction between NVAS and early MV = @ ) .


From @ to @ months NVAS was not associated with mortality .


Overall , from @ to @ months NVAS was associated with increased mortality in early MV recipients ( Mortality rate ratio = @ ( @ % confidence interval : @ , @ ) ) .


These observations indicate that NVAS may interact with vaccines given several months later .


This may have implications for the planning of future child intervention programs .


To evaluate the efficacy and safety of adjunctive eslicarbazepine acetate ( ESL ) in patients with refractory partial-onset seizures .


This randomized , placebo-controlled , double-blind , parallel-group , phase III study was conducted at @ centers in @ countries , including the United States and Canada .


Eligible patients were aged @ years and had uncontrolled partial-onset seizures despite treatment with @-@ antiepileptic drugs ( AEDs ) .


After an @-week baseline period , patients were randomized to once-daily placebo ( n = @ ) , ESL @ mg ( n = @ ) , or ESL @,@ mg ( n = @ ) .


Following a @-week titration period , patients received ESL @ or @,@ mg once-daily for @ weeks .


Seizure data were captured and documented using event-entry or daily entry diaries .


Standardized seizure frequency ( SSF ) during the maintenance period ( primary end point ) was reduced with ESL @,@ mg ( p = @ ) , and there was a trend toward improvement with ESL @ mg ( p = @ ) , compared with placebo .


When data for titration and maintenance periods were combined , ESL @ mg ( p = @ ) and @,@ mg ( p < @ ) both reduced SSF .


There were no statistically significant interactions between treatment response and geographical region ( p = @ ) or diary version ( p = @ ) .


Responder rate ( @ % reduction in SSF ) was significantly higher with ESL @,@ mg ( @ % , p < @ ) but not ESL @ mg ( @ % , p = @ ) than placebo ( @ % ) .


Incidence of treatment-emergent adverse events ( TEAEs ) and TEAEs leading to discontinuation increased with ESL dose .


The most common TEAEs were dizziness , somnolence , nausea , headache , and diplopia .


Adjunctive ESL @,@ mg once-daily was more efficacious than placebo in adult patients with refractory partial-onset seizures .


The once-daily @ mg dose showed a marginal effect on SSF , but did not reach statistical significance .


Both doses were well tolerated .


Efficacy assessment was not affected by diary format used .


To determine whether the use of narrow-band imaging ( NBI ) system could enhance the detection rate of esophageal squamous cell carcinoma and precancerous lesions during endoscopic examination of the esophagus .


@ patients were randomized to undergo endoscopic examination using high definition television ( HDTV ) narrow band imaging ( NBI ) endoscopy or HDTV WL endoscopy .


The primary endpoint was the difference in the neoplasm miss rate , and secondary outcome was the neoplasm detection rate .


The number of esophageal cancer and high grade intraepithelial neoplasia lesions detected by HD-NBI and HD-WL was @ and @ , respectively .


The neoplasm miss rate per lesion and per patient with HD-NBI showed significant difference compared with that of HD-WL ( P < @ ) .


Characteristics of lesions missed by use of HD-NBI were similar to those missed by use of HD-WL ; all missed lesions were high grade intraepithelial neoplasia lesions .


Significant difference was observed between NBI and WL in adenoma detection rate ( @ % vs. @ % , P < @ ) .


Endoscopy with HD-NBI seems to improve the detection of esophageal cancer and precancerous lesions , high definition may be tested for its effect on detection of esophageal cancer and precancerous lesions in the future .


These results indicate that endoscopy routinely using the NBI system for the surveillance of esophageal cancer and precancerous lesions may be recommended .


This single-center , prospective , randomized , double-blind , @-arm , parallel group comparison trial was performed to establish whether the adult-sized laryngeal mask airway ( LMA ) Classic ( The Laryngeal Mask Company Ltd , Henley-on-Thames , UK ) could be used safely without any consideration of cuff hyperinflation when a cuff of the LMA Classic was inflated using half the maximum inflation volume or the resting volume before insertion of device .


Eighty patients aged @ to @ years scheduled for general anesthesia using the LMA Classic were included .


Before insertion , the cuff was partially filled with half the maximum inflation volume in the half volume group or the resting volume created by opening the pilot balloon valve to equalize with atmospheric pressure in the resting volume group .


Several parameters regarding insertion , intracuff pressure , airway leak pressure , and leakage volume/fraction were collected after LMA insertion .


The LMA Classic with a partially inflated cuff was successfully inserted in all enrolled patients .


Both groups had the same success rate of @ % at the first insertion attempt .


The half volume group had a lower mean intracuff pressure compared with the resting volume group ( @ @ cm H@O vs @ @ cm H@O ; P = @ ) .


There was no difference in airway leak pressure or leakage volume/fraction between the @ groups under mechanical ventilation .


The partially inflated cuff method using half the maximum recommended inflation volume or the resting volume is feasible with the adult-sized LMA Classic , resulting in a high success rate of insertion and adequate range of intracuff pressures .


With advances in imaging and radiotherapy , the prognostic value of skull-base invasion in nasopharyngeal carcinoma ( NPC ) needs to be reassessed .


We aimed to define a classification system and evaluate the prognostic value of the classification of magnetic resonance imaging ( MRI ) - detected skull-base invasion in NPC treated with intensity-modulated radiotherapy ( IMRT ) .


We retrospectively reviewed @ patients who underwent MRI and were subsequently histologically diagnosed with nondisseminated NPC and treated with IMRT .


MRI-detected skull-base invasion was not found to be an independent prognostic factor for overall survival ( OS ) , distant metastasis-free survival ( DMFS ) , local relapse-free survival ( LRFS ) , or disease-free survival ( DFS ; p > @ for all ) .


Skull-base invasion was classified according to the incidence of each site ( type I sites inside pharyngobasilar fascia and clivus vs. type II sites outside pharyngobasilar fascia ) .


The @-year OS , DMFS , LRFS , and DFS rates in the classification of skull-base invasion in NPC were @ vs. @ % , @ vs. @ % , @ vs. @ % , and @ vs. @ % , respectively ( p < @ for all ) .


Multivariate analysis indicated the classification of skull-base invasion was an independent prognostic factor .


MRI-detected skull-base invasion is not an independent prognostic factor in patients with NPC treated with IMRT .


However , classification according to the site of invasion has prognostic value .


Therefore , patients with various subclassifications of stage T@ disease may receive treatment with different intensities ; however , further studies are warranted to prove this .


Remote Patient Management for chronic heart failure ( CHF ) is gaining increasing importance in health care .


Telemonitoring is defined as daily measuring of health parameters by the patient and their transmission to a telemedical centre .


The adherence of this action by the patient can be considered as a measure for RPM adoption .


The randomized controlled clinical trial TIM-HF ( NCT @ ) was conducted between @ and @ with @ CHF patients with the primary endpoint total mortality for a mean follow-up of @ @ months .


The non-prespecified analysis of adherence to daily measuring of ECG , blood pressure , weight and self-assessment was focused on sociodemographic and disease-related factors of the @ RPM patients .


The mean adherence to telemonitoring was more than @ % ( absolute adherence : @ @ % , relative adherence : @ @ % ) .


From the beginning of treatment @ % of the patients ( @/@ ) have shown an adherence below average .


The high adherence of the majority of the patients was stable for the entire study duration and irrespective of age , sex , severity of the disease and the presence of mild to moderate depression .