Among men with elevated PSA and negative pre-study biopsy in REDUCE , in which biopsies were largely PSA independent , smoking was unrelated to overall prostate cancer diagnosis but was associated with increased risk of high-grade prostate cancer .


Down syndrome is a frequent cause of intellectual disability , with severe impact on the quality of life of affected individuals and their families , and high social costs .


Intervention programs should start soon after birth but no consensus exists on specific types and timing of early interventions in this population .


This pilot study explores the effects of an early multi-sensory intervention , based on body massage , on the development of visual function in infants with Down syndrome .


Infants were randomly allocated to either a massage or a control group .


Intervention consisted of only standard care ( Control Group ) or standard care plus infant massage ( Massaged Group ) .


Visual acuity was assessed by Teller Acuity Cards and stereopsis by the Frisby Stereopsis Screening Test at @ , @ , @ and @ months .


Massaged Group Infants showed a significantly higher visual acuity at @ months of age and an accelerated development up to at least @ months ; compared to Controls , stereopsis had an earlier onset in the Massaged Group followed by a faster maturation .


Environmental enrichment , in the tested form of infant massage , seems to affect maturation of visual functions in human infants , also in the presence of a genetic disability , when applied during a period of high brain plasticity .


To describe risk factors for scar in eyes treated with ranibizumab or bevacizumab for neovascular age-related macular degeneration ( AMD ) .


Prospective cohort study within a randomized clinical trial .


Patients with no scar on color fundus photography ( CFP ) or fluorescein angiography ( FA ) at enrollment in the Comparison of Age-related Macular Degeneration Treatments Trials ( CATT ) .


Eyes were assigned to ranibizumab or bevacizumab treatment and to @ of @ dosing regimens for @ years .


Masked readers assessed CFP and FA .


Baseline demographic characteristics , visual acuity , morphologic features on photography and optical coherence tomography ( OCT ) , and genotypes associated with AMD risk were evaluated as risk factors using adjusted hazard ratios ( aHRs ) and associated @ % confidence intervals ( CIs ) .


Scars were classified as fibrotic with well-demarcated elevated mounds of yellowish whitetissue or nonfibrotic with discrete flat areas of hyperpigmentation with varying amounts of central depigmentation .


Scar formation .


Scar developed in @ of @ eyes ( @ % ) by @ years .


Baseline characteristics associated with greater risk of scarring were predominantly classic choroidal neovascularization ( CNV ) ( aHR , @ ; CI , @-@ @ ) versus occult CNV , blocked fluorescence ( aHR , @ ; CI , @-@ @ ) , foveal retinal thickness > @ m ( aHR , @ ; CI , @-@ @ ) versus < @ m , foveal subretinal tissue complex thickness > @ m ( aHR , @ ; CI , @-@ @ ) versus @ m , foveal subretinal fluid ( aHR , @ ; CI , @-@ @ ) versus no subretinal fluid , and subretinal hyperreflective material ( SHRM ) ( aHR , @ ; CI , @-@ @ ) versus no SHRM .


Eyes with elevation of the retinal pigment epithelium had lower risk ( aHR , @ ; CI , @-@ @ ) versus no elevation .


Drug , dosing regimen , and genotype had no statistically significant association with scarring .


Fibrotic scars developed in @ % of eyes , and nonfibrotic scars developed in @ % of eyes .


Baseline risk factors for the scar types were similar except that eyes with larger lesion size or visual acuity < @/@ were more likely to develop fibrotic scars .


Approximately half of eyes enrolled in CATT developed scar by @ years .


Eyes with classic neovascularization , a thicker retina , and more fluid or material under the foveal center of the retina are more likely to develop scar .


Post hoc analyses were conducted to evaluate the efficacy of levomilnacipran extended-release ( ER ) in subgroups of patients with major depressive disorder ( MDD ) .


Data were pooled from @ completed Phase II/III studies .


Patients were categorized by sex , age , MDD duration , recurrence of MDD , current episode duration , number of prior episodes , and baseline Montgomery-sberg Depression Rating Scale ( MADRS ) score .


Efficacy was evaluated by MADRS least squares ( LS ) mean change from baseline , response ( MADRS improvement @ % ) , and remission ( MADRS @ ) .


In the pooled population , treatment with levomilnacipran ER versus placebo resulted in greater improvement in MADRS score ( -@ versus -@ ; LS mean difference , -@ ; P < @ ) and higher response rates ( @ % versus @ % ; P < @ ) .


Comparable treatment effects were found in most subgroups .


Remission rates in the overall population were higher for levomilnacipran ER versus placebo ( @ % versus @ % ; P < @ ) ; notably high remission rates were seen in patients with baseline MADRS score < @ ( @ % versus @ % ; P < @ ) .


Discussion Clinically meaningful improvements in depressive symptoms were found across subgroups , including statistically significant outcomes for both response and remission .


Levomilnacipran ER was efficacious across a wide range of MDD patients , including men and women , ages @-@ , with varying histories and symptom severity .


During long-term anticoagulation in atrial fibrillation , temporary interruptions ( TIs ) of therapy are common , but the relationship between patient outcomes and TIs has not been well studied .


We sought to determine reasons for TI , the characteristics of patients undergoing TI , and the relationship between anticoagulant and outcomes among patients with TI .


In the Rivaroxaban Once Daily , Oral , Direct Factor Xa Inhibition Compared With Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation ( ROCKET AF ) , a randomized , double-blind , double-dummy study of rivaroxaban and warfarin in nonvalvular atrial fibrillation , baseline characteristics , management , and outcomes , including stroke , non-central nervous system systemic embolism , death , myocardial infarction , and bleeding , were reported in participants who experienced TI ( @-@ days ) for any reason .


The at-risk period for outcomes associated with TI was from TI start to @ days after resumption of study drug .


In @ @ participants who received at least @ dose of study drug , @ ( @ % ) experienced TI .


Participants with TI were similar to the overall ROCKET AF population in regard to baseline clinical characteristics .


Only @ % ( n = @ ) of TI incidences involved bridging therapy .


Stroke/systemic embolism rates during the at-risk period were similar in rivaroxaban-treated and warfarin-treated participants ( @ % versus @ % per @ days ; hazard ratio -LSB- confidence interval -RSB- = @ -LSB- @-@ @ -RSB- ; P = @ ) .


Risk of major bleeding during the at-risk period was also similar in rivaroxaban-treated and warfarin-treated participants ( @ % versus @ % per @ days ; hazard ratio -LSB- confidence interval -RSB- = @ -LSB- @-@ @ -RSB- ; P = @ ) .


TI of oral anticoagulation is common and is associated with substantial stroke risks and bleeding risks that were similar among patients treated with rivaroxaban or warfarin .


Further investigation is needed to determine the optimal management strategy in patients with atrial fibrillation requiring TI of anticoagulation .


The purpose of this study was to characterize the relationship between heart rate and post-discharge outcomes in patients with hospitalization for heart failure ( HHF ) with reduced ejection fraction ( EF ) in sinus rhythm .


A reduction in heart rate improves clinical outcomes in patients with chronic heart failure and in sinus rhythm , but the association between heart rate and post-discharge outcomes in patients with HHF is presently unclear .


This post-hoc analysis of the EVEREST ( Efficacy of Vasopressin Antagonism in Heart Failure : Outcome Study With Tolvaptan ) trial examined @,@ patients with HHF and EF@ % not in atrial fibrillation/flutter or pacemaker dependent .


The median follow-up period was @ months .


At baseline , patients with a higher heart rate tended to be younger with lower EF and were more likely to have worse New York Heart Association functional class and higher natriuretic peptide levels .


After adjustment for clinical risk factors , baseline heart rate was not predictive of all-cause mortality ( p @ ) .


However , at@ beats/min , every @-beat increase in @-week post-discharge heart rate was independently associated with increased all-cause mortality ( hazard ratio : @ -LSB- @ % confidence interval : @ to @ -RSB- ; p = @ ) .


Similarly , every @-beat increase@ beats/min in @-week post-discharge heart rate was predictive of all-cause mortality ( hazard ratio : @ -LSB- @ % confidence interval : @ to @ -RSB- ; p = @ ) .


In this large cohort of patients with HHF with reduced EF and in sinus rhythm , baseline heart rate did not correlate with all-cause mortality .


In contrast , at@ beats/min , higher heart rate in the early post-discharge period was independently predictive of death during subsequent follow-up .


Further study of post-discharge heart rate as a potential therapeutic target in this high-risk population is encouraged .


Epidural infusion of levobupivacaine and ropivacaine provides adequate postoperative pain management by minimizing side effects related to IV opioids and improving patient outcome .


The safety profile of different drugs can be better estimated by comparing their pharmacokinetic profiles than by considering their objective side effects .


Because levobupivacaine and ropivacaine have different pharmacokinetic properties , our aim was to investigate whether there is a difference in the pharmacokinetic variability of the @ drugs in a homogeneous population undergoing continuous epidural infusion .


This double-blind , multicenter , randomized , controlled trial study was designed to compare the pharmacokinetics of continuous thoracic epidural infusion of levobupivacaine @ % or ropivacaine @ % for postoperative pain management in adult patients who had undergone major abdominal , urological , or gynecological surgery .


This study is focused on the evaluation of the coefficient of variation ( CV ) to assess the equivalence in the systemic exposure and interindividual variability between levobupivacaine and ropivacaine and , therefore , the possible differences in the predictability of the plasmatic concentrations of the @ drugs during thoracic epidural infusion .


One hundred eighty-one adults undergoing major abdominal surgery were enrolled in the study .


Patients were randomized to receive an epidural infusion of levobupivacaine @ % + sufentanil @ g/mL or of ropivacaine @ % + sufentanil @ g/mL at @ mL/h for @ hours .


The primary end point of this study was to analyze the variability of plasma concentration of levobupivacaine and ropivacaine via an area under the curve within a range of @ % of the CV during @ hours of continuous epidural infusion .


The CV shows how the concentration values of local anesthetics are scattered around the median concentration value , thus indicating the extent to which plasma concentration is predictable during infusion .


Secondary end points were to assess the pharmacologic profile of the local anesthetics used in the study , including an analysis of mean peak plasma concentrations , and also to assess plasma clearance , side effects , pain intensity ( measured with a verbal numeric ranging score , i.e. , static Numeric Rating Scale -LSB- NRS -RSB- and dynamic NRS -RSB- ) , and the need for rescue doses .


The comparison between the @ CVs showed no statistical difference : the difference between area under the curve was within the range of @ % .


The CV was @ for levobupivacaine and @ for ropivacaine ( P = @ ) .


The plasma concentrations of ropivacaine approached the Cmax significantly faster than those of levobupivacaine .


Clearance of ropivacaine decreases with increasing patient age .


There were no significant differences in NRS , dynamic NRS scores , the number of rescue doses , or in side effects between groups .


Considering the CV , the interindividual variability of plasma concentration for levobupivacaine and ropivacaine is equivalent after thoracic epidural infusion in adults .


We found a reduction in clearance of ropivacaine depending on patient age , but this finding could be the result of some limitations of our study .


The steady-state concentration was not reached during the @-hour infusion and the behavior of plasma concentrations of ropivacaine and levobupivacaine during continuous infusions lasting more than @ hours remains to be investigated , because they could reach toxic levels .


Finally , no differences in the clinical efficacy or in the incidence of adverse effects between groups were found for either local anesthetic .


The risk of urinary tract infection ( UTI ) among women undergoing elective gynecological surgery during which a catheter is placed is high : @-@ % following catheter removal .


We conducted the first randomized , double-blind , placebo-controlled trial of the therapeutic efficacy of cranberry juice capsules in preventing UTI after surgery .


We recruited patients from a single hospital between August @ and January @ .


Eligible participants were undergoing elective gynecological surgery that did not involve a fistula repair or vaginal mesh removal .


One hundred sixty patients were randomized and received @ cranberry juice capsules @ times a day , equivalent to @ @ ounce servings of cranberry juice , for @ weeks after surgery or matching placebo .


The primary endpoint was the proportion of participants who experienced clinically diagnosed and treated UTI with or without positive urine culture .


Kaplan-Meier plots and log rank tests compared the @ treatment groups .


The occurrence of UTI was significantly lower in the cranberry treatment group compared with the placebo group ( @ of @ -LSB- @ % -RSB- vs @ of @ -LSB- @ % -RSB- ; odds ratio , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


After adjustment for known confounders , including the frequency of intermittent self-catheterization in the postoperative period , the protective effects of cranberry remained ( odds ratio , @ ; @ % confidence interval , @-@ @ ) .


There were no treatment differences in the incidence of adverse events , including gastrointestinal upset ( @ % vs @ % for cranberry vs placebo ) .


Among women undergoing elective benign gynecological surgery involving urinary catheterization , the use of cranberry extract capsules during the postoperative period reduced the rate of UTI by half .


Just as hip prosthesis , most of the patients undergoing orthopedic lower extremity surgery ( OLES ) belong to the advanced age group .


Sciatic nerve block combined with psoas compartment block is used as a technique alternative to central neuraxial block and GA. .


In geriatric patients that will undergo partial hip prosthesis , the effects of the methods of unilateral spinal anesthesia ( SA ) and L@ paravertebral block combined with psoas compartment block ( PCB ) and sciatic nerve block ( PCSL ) on peroperative hemodynamic parameters and the duration of need for postoperative analgesia were studied .


Fifty patients from the ASA III-IV group were randomly divided into two groups .


Group SA was administered spinal anesthesia with hyperbaric bupivacaine ( @ ml , @ % ) from the selected intervertebral distance ( L@-L@ or L@-L@ ) in lateral position .


Group PCSL was administered L@ paravertebral block combined with PCB and sciatic nerve block with bupivacaine hydrochloride ( total @ ml ) .


Hemodynamic parameters ( HR : heart rate and MAP : mean artery pressure ) were recorded in pre - and post-intervention @-minute intervals .


The initial time of the need for analgesia of patients were evaluated postoperatively .


Any failure in methods implemented on patients in either group was not observed .


Times of anesthesia and surgical preparation of patients were observed to have significantly prolonged in the PCSL compared to Group SA ( p < @ ) .


Hundred and @th and @th min .


mean arterial pressures of patients was found to be significantly higher in Group SA compared to Group PCSL ( p < @ ) .


The initial time of the need for analgesia was observed to be significantly prolonged in Group PCSL ( @ @ min ) compared to Group SA ( @ @ min ) ( p < @ ) .


Unilateral SA conducted with bupivacaine hydrochloride and PCSL block technique provided a hemodynamically similar activity in the perioperative period in patients that underwent partial hip operation .


However , PCSL block implementation extended the initial time of the need for analgesia in postoperative period .


PCSL method could be selected in cases belonging to such group of patients .


PCSL block can be a alternative anesthetic tecniques in patients that underwent partial hip operation .


This study compared the efficacy and safety of dual add-on of saxagliptin plus dapagliflozin versus saxagliptin and dapagliflozin added on alone in patients with type @ diabetes poorly controlled with metformin .


This was a double-blind trial in adults with HbA@c @ % and @ % ( @-@ mmol/mol ) , randomized to saxagliptin ( SAXA ) ( @ mg/day ) plus dapagliflozin ( DAPA ) ( @ mg/day ; n = @ ) , or SAXA ( @ mg/day ) and placebo ( n = @ ) , or DAPA ( @ mg/day ) and placebo ( n = @ ) on background metformin extended release ( MET ) @,@ mg/day .


Primary objective compared changes from baseline in HbA@c with SAXA+DAPA+MET versus SAXA+MET and DAPA+MET .


Patients had a mean baseline HbA@c of @ % ( @ mmol/mol ) , diabetes duration of @ years , and a BMI of @ kg/m ( @ ) .


At week @ , the adjusted mean change from the baseline HbA@c was -@ % ( -@ mmol/mol ) with SAXA+DAPA+MET versus -@ % ( -@ mmol/mol ) with SAXA+MET ( difference -@ % -LSB- -@ mmol/mol -RSB- , P < @ ) and -@ % ( -@ mmol/mol ) with DAPA+MET ( difference -@ % -LSB- @ mmol/mol -RSB- , P < @ ) .


The proportion of patients achieving HbA@c < @ % ( @ mmol/mol ) was @ % with SAXA+DAPA+MET versus @ % with SAXA+MET and @ % with DAPA+MET .


Urinary and genital infections occurred in @ % of patients receiving SAXA+DAPA+MET .


Hypoglycemia was infrequent , with no episodes of major hypoglycemia .


In this first report of adding a well-tolerated combination of saxagliptin plus dapagliflozin to background metformin therapy in patients poorly controlled with metformin , greater improvements in glycemic control were obtained with triple therapy by the dual addition of saxagliptin and dapagliflozin than dual therapy with the addition of saxagliptin or dapagliflozin alone .


A challenge for automated glycemic control in type @ diabetes ( T@D ) is the large variation in insulin needs between individuals and within individuals at different times in their lives .


The objectives of the study was to test the ability of a third-generation bihormonal bionic pancreas algorithm , initialized with only subject weight ; to adapt automatically to the different insulin needs of adults and adolescents ; and to evaluate the impact of optional , automatically adaptive meal-priming boluses .


This was a randomized controlled trial .


The study was conducted at an inpatient clinical research center .


Twelve adults and @ adolescents with T@D participated in the study .


Subjects in each age group were randomized to automated glycemic control for @ hours with or without automatically adaptive meal-priming boluses .


Mean plasma glucose ( PG ) , time with PG less than @ mg/dL , and insulin total daily dose were measured .


The @-hour mean PG values with and without adaptive meal-priming boluses were @ @ vs @ @ mg/dL ( P = @ ) in adults and @ @ vs @ @ mg/dL ( P = @ ) in adolescents .


Adaptive meal-priming boluses improved mean PG without increasing time spent with PG less than @ mg/dL : @ % vs @ % ( P = @ ) in adults and @ % vs @ % ( P = @ ) in adolescents .


Large increases in adaptive meal-priming boluses and shifts in the timing and size of automatic insulin doses occurred in adolescents .


Much less adaptation occurred in adults .


There was nearly a @-fold variation in the total daily insulin dose across all cohorts ( @-@ @ U/kg d ) .


A single control algorithm , initialized only with subject weight , can quickly adapt to regulate glycemia in patients with TID and highly variable insulin requirements .


In this study , we compared the efficacy and safety of the oral fluoropyrimidine S-@ as monotherapy or in combination with leucovorin as the second-line treatment for patients with metastatic pancreatic cancer whose disease had progressed on gemcitabine treatment .


The study was a randomized , open-label , controlled study .


Patients randomly received S-@ or S-@ in combination with leucovorin ( SL arm ) in @-day cycles .


The primary endpoint was the @-month survival rate .


A total of @ patients were randomized to S-@ ( n = @ ) and SL ( n = @ ) .


No statistically significant differences were observed between the two arms with regard to @-month survival rates ( @ % vs. @ % ) , median overall survival ( @ vs. @ months ) , median progression-free survival ( @ vs. @ months ) , and overall response rate ( @ % vs. @ % ) .


The rate of major grade @-@ adverse events of digestive toxicity was significantly higher in the SL arm than in the S-@ arm .


Compared with S-@ , SL did not improve the survival of patients with metastatic pancreatic cancer who had failed to benefit from prior gemcitabine treatment , but SL had a higher adverse event rate .


The purpose of this article was to test whether physical activity , healthy eating , and emotional well-being would improve if patients received feedback about biomarkers that have been shown to be responsive to changes in weight and fitness .


Patients were randomized to limited feedback ( weight , body mass index -LSB- BMI -RSB- , and blood pressure at @ and @ months ) or enhanced feedback ( weight , BMI , blood pressure , homeostatic insulin resistance , and nuclear magnetic resonance lipoprotein profiles at @ , @ , @ , and @ months ) .


Repeated measures mixed effects multivariate regression models were used to determine whether BMI , fitness , diet , and quality of life changed over time .


Major parameters were similar in both groups at baseline .


BMI , measures of fitness , healthy eating , quality of life , and health state improved in both patient groups , but there was no difference between patient groups at @ or @ months .


Systolic blood pressure improved in the enhanced feedback group , and there was a difference between the enhanced and limited feedback groups at @ months ( @ % confidence interval , -@ to -@ ) .


Providing patients with enhanced feedback did not dramatically change outcomes .


However , across groups , many patients maintained or lost weight , suggesting the need for more study of nondiet interventions .


The aim of this study was to investigate the influence of PreloxR , a combination of French maritime pine bark extract ( Pycnogenol ) , L-arginine , L-citrulline and roburins , on male fertility .


Sperm quality of @ subfertile men was tested in monthly intervals in a double-blind , randomized , placebo controlled , crossover study .


Patients received @ tablets PreloxR or placebo twice daily during test periods .


Following a run-in period of @ month , patients received either PreloxR or a placebo for @ month .


After a wash-out period of @ month , patients received PreloxR or a placebo in a crossover manner for @ month .


Sperm volume , concentration of spermatozoa , total count , motility , vitality and morphology were measured by standard methods of calculation of the Fertility Index ( FI ) in monthly intervals .


Activity of e-NOS in sperm was evaluated in parallel by measuring the quantity of L-citulline produced from L-arginine .


Supplementation with PreloxR enhanced sperm volume and concentration , motility , vitality and morphology significantly versus placebo .


The Fertility Index rose to normal values during treatment with PreloxR .


e-NOS activity in sperm was elevated by PreloxR .


No adverse effects were reported .


PreloxR offers a safe method to improve quality of human spermatozoa in subfertile men .


The aim of this study was to assess whether or not a theory-based behaviour change intervention delivered by trained and quality-assured lifestyle facilitators can achieve and maintain improvements in physical activity , dietary change , medication adherence and smoking cessation in people with recently diagnosed type @ diabetes .


An explanatory randomised controlled trial was conducted in @ general practices in Eastern England ( Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen Detected Diabetes in Primary Care-Plus -LSB- ADDITION-Plus -RSB- ) .


In all , @ patients meeting eligibility criteria ( age @ to @ years with recently diagnosed screen or clinically detected diabetes ) were individually randomised to receive either intensive treatment ( n = @ ) or intensive treatment plus a theory-based behaviour change intervention led by a facilitator external to the general practice team ( n = @ ) .


Randomisation was central and independent using a partial minimisation procedure to balance stratifiers between treatment arms .


Facilitators taught patients skills to facilitate change in and maintenance of key health behaviours , including goal setting , self-monitoring and building habits .


Primary outcomes included physical activity energy expenditure ( individually calibrated heart rate monitoring and movement sensing ) , change in objectively measured fruit and vegetable intake ( plasma vitamin C ) , medication adherence ( plasma drug levels ) and smoking status ( plasma cotinine levels ) at @ year .


Measurements , data entry and laboratory analysis were conducted with staff unaware of participants ' study group allocation .


Of @ participants still alive , @ ( @ % ; intervention group @ % , comparison group @ % ) attended @-year follow-up .


There were no significant differences between groups in physical activity ( difference : +@ kJ kg ( -@ ) day ( -@ ) ; @ % CI -@ , @ ) , plasma vitamin C ( difference : -@ mol/l ; @ % CI -@ , @ ) , smoking ( OR @ ; @ % CI @ , @ ) and plasma drug levels ( difference in metformin levels : -@ mol/l ; @ % CI -@ , @ ) .


Cardiovascular risk factors and self-reported behaviour improved in both groups with no significant differences between groups .


For patients with recently diagnosed type @ diabetes receiving intensive treatment in UK primary care , a facilitator-led individually tailored behaviour change intervention did not improve objectively measured health behaviours or cardiovascular risk factors over @ year .


Early poststroke aphasia rehabilitation effects and their functional MRI ( fMRI ) correlates were investigated in a pilot , controlled longitudinal study .


Twelve patients with mild/moderate aphasia ( @ Broca , @ anomic , and @ Wernicke ) were randomly assigned to daily language rehabilitation for @ weeks ( starting @ -LSB- mean -RSB- days poststroke ) or no rehabilitation .


The Aachen Aphasia Test and fMRI recorded during an auditory comprehension task were performed at @ time intervals : mean @ ( T@ ) , @ ( T@ ) , and @ ( T@ ) days poststroke .


Groups did not differ in terms of age , education , aphasia severity , lesions volume , baseline fMRI activations , and in task performance during fMRI across examinations .


Rehabilitated patients significantly improved in naming and written language tasks ( P < @ ) compared with no rehabilitation group both at T@ and T@ .


Functional activity at T@ was reduced in language-related cortical areas ( right and left inferior frontal gyrus and middle temporal gyrus , right inferior parietal lobule and superior temporal gyrus ) in patients compared with controls .


T@ and T@ follow-ups revealed a cortical activation increase , with significantly greater activation in the left hemisphere areas in rehabilitated patients at T@ and T@ , and a timetreatment effect at T@ in the left inferior Broca area after rehabilitation .


Left inferior frontal gyrus activation at T@ significantly correlated with naming improvement .


Early poststroke aphasia treatment is useful , has durable effects , and may lead to early enhanced recruitment of brain areas , particularly the left inferior frontal gyrus , which persists in the chronic phase .


In this study , a combination of recombinant adenoviral p@ ( rAd-p@ ) gene therapy and intra-arterial delivery of chemotherapeutic agents for treatment of oral squamous cell carcinoma was evaluated .


In total , @ patients with stage III or IV oral carcinoma who had refused or were ineligible for surgery were enrolled in a randomized , placebo-controlled , double-blind , phase III clinical trial .


They were randomly assigned to group I ( n = @ ; intra-arterial infusion of rAd-p@ plus chemotherapy ) , group II ( n = @ ; intra-arterial infusion of rAd-p@ plus placebo chemotherapy ) , or group III ( n = @ ; intra-arterial infusion of placebo rAd-p@ plus chemotherapy ) .


The median length of follow-up was @ months ( range , @ to @ months ) .


During follow-up , @ patients in group I , @ in group II , and @ in group III died .


Group I ( @ % ) had a higher complete response rate than groups II ( @ % ) and III ( @ % ) ( P = @ ) .


The rate of non-responders in group I was significantly lower than that in groups II and III ( P < @ ) .


A log-rank test for survival rate indicated that group I had a significantly higher survival rate than group III ( P = @ ) .


The survival rate of patients with stage III but not stage IV oral cancer was significantly higher in group I than in group III ( P = @ , P = @ , respectively ) .


The survival rate of patients with stage IV did not differ significantly among the three groups .


Or the @ patients , @ patients experienced adverse events of either transient flu-like symptoms or bone marrow suppression , while @ patients had both these conditions together .


No replication-deficient virus was detected in patient serum , urine , or sputum .


rAd-p@ treatment increased Bax expression in the primary tumor of @ % of patients , as shown by immunohistochemical staining .


Intra-arterial infusion of combined rAd-p@ and chemotherapy significantly increased the survival rate of patients with stage III but not stage IV oral cancer , compared with intra-arterial chemotherapy .


Intra-arterial infusion of combined rAd-p@ and chemotherapy may represent a promising alternative treatment for oral squamous cell carcinoma .


High bilirubin/albumin ( B/A ) ratios increase the risk of bilirubin neurotoxicity .


The B/A ratio may be a valuable measure , in addition to the total serum bilirubin ( TSB ) , in the management of hyperbilirubinemia .


We aimed to assess whether the additional use of B/A ratios in the management of hyperbilirubinemia in preterm infants improved neurodevelopmental outcome .


In a prospective , randomized controlled trial , @ preterm infants of @ weeks ' gestation or less were randomly assigned to treatment based on either B/A ratio and TSB thresholds ( consensus-based ) , whichever threshold was crossed first , or on the TSB thresholds only .


The primary outcome was neurodevelopment at @ to @ months ' corrected age as assessed with the Bayley Scales of Infant Development III by investigators unaware of treatment allocation .


Secondary outcomes included complications of preterm birth and death .


Composite motor ( @ @ vs. @ @ ) and cognitive ( @ @ vs. @ @ ) scores did not differ between the B/A ratio and TSB groups .


Demographic characteristics , maximal TSB levels , B/A ratios , and other secondary outcomes were similar .


The rates of death and/or severe neurodevelopmental impairment for the B/A ratio versus TSB groups were @ % versus @ % ( P = @ ) and @ % versus @ % ( P = @ ) for birth weights @ g and @ % versus @ % ( P = @ ) and @ % versus @ % ( P = @ ) for birth weights of > @ g.


The additional use of B/A ratio in the management of hyperbilirubinemia in preterm infants did not improve their neurodevelopmental outcome .


This study evaluated clinical pharmacy costs against drug costs .


We conducted a randomized interventional comparative trial at the surgical intensive care unit ( ICU ) of Ghent University Hospital , Belgium ( period B : group B@ with pharmacist consultation ; control group B@ ) .


We obtained before ( period A ) and after ( period C ) control groups using @:@ propensity score matching with B@ and B@ .


Mean daily ICU drug costs with standard error of the mean ( SEM ) were compared between B@ and B@ ( primary analysis ) and between matched pairs ( AB@ , AB@ , CB@ and CB@ ; secondary analysis ) .


For B , we performed a @ bootstrapping ( by resampling B@ and B@ ) , calculated the benefit-cost ratio using pharmacy time ( gross salary ) as cost ( euros ) and drug cost savings as benefit .


We performed sensitivity analysis with and without outlier drug costs ( i.e. twice the standard deviation ) .


Belgian health care payer .


In period B , @ patients were randomized : B@ , n = @ ; B@ , n = @ .


Pharmacists provided recommendations in @/@ ( @ % ) therapies with @ % acceptance .


Mean drug cost difference between B@ ( @ euros , SEM @ ) and B@ ( @ euros , SEM @ ) ( P = @ ) became significant after excluding outlier drug costs ( B@ , @ euros , SEM @ ; B@ , @ euros , SEM @ ; P < @ ) .


Recommendations were cost-beneficial ( break-even drug costs or savings ) in @ % of patients with a benefit-cost ratio of @:@ ( confidence interval -@:@ to @:@ ) .


In sensitivity analysis excluding outlier drug costs , B@ costs were significantly higher than both A and C , indicating high baseline expenses in B@ .


The randomized interventional comparative trial in a small ICU patient group suggested the potential cost-benefit of clinical pharmacy on daily ICU drug costs .


However , after matching , this benefit was attenuated .


A final conclusion demands a larger randomized trial adopting a similar design with matched controls .


Future research should include clinical impact of recommendations .


ACT-@ is a new reversible , selective , and potent antagonist of the platelet P@Y@ receptor .


This study was a first-in-man trial investigating the tolerability , pharmacokinetics , and pharmacodynamics of single oral doses of ACT-@ and its di-ester prodrug ( ACT-@ ) in healthy males .


The study had a double-blind , randomized , ascending single-dose design with an oral formulation F@ ( i.e. , ACT-@ or placebo ) ( Part I ) and an open-label , randomized , @-period , crossover design comparing exploratory formulations of ACT-@ ( F@ ) @mg and ACT-@ ( dF ) @mg to F@ @mg ( Part II ) .


In Part I , doses up to @,@ mg were tested in @ healthy subjects .


Nine healthy subjects were enrolled in Part II .


Standard safety parameters , inhibition of platelet aggregation , and ACT-@ plasma concentrations were measured .


Non-compartmental pharmacokinetic analysis was performed .


All doses and formulations were well tolerated .


The most frequent adverse event was headache , whereas no events of bleeding or dyspnea were reported .


In Part I , ACT-@ area under the plasma concentration-time curve ( AUC ) increased dose-proportionally whereas maximum plasma concentration ( C max ) was less than dose-proportional .


The highest C max -LSB- geometric mean ( @ % CI ) -RSB- at @,@ mg was @ ( @ , @ ) pmol/mL at @ h post-dose , terminal half-life ( t ) was ~ @h .


ACT-@ C max and AUC@ - ratios of geometric means ( @ % CI ) using F@ as reference , for F@ were @ ( @ , @ ) and @ ( @ , @ ) , respectively , and for dF @ ( @ , @ ) and @ ( @ , @ ) , respectively .


Mean peak platelet inhibition was @ % after F@ ( @,@ mg ) and @ % after F@ .


Oral doses of ACT-@ and ACT-@ were well tolerated .


Platelet inhibition correlated with ACT-@ exposure .


Exploratory formulations enhanced the bioavailability and antiplatelet effect of ACT-@ .


An inverse relationship between ( serum ) total bilirubin and risk of cardiovascular disease has been reported previously , but longitudinal data on overweight and obese patients are lacking .


We have investigated the relationship between total bilirubin and cardiovascular adverse events in a large group of patients with risk factors for cardiovascular disease who were enrolled in a large weight loss trial .


Data from the Sibutramine Cardiovascular Outcomes ( SCOUT ) trial , including almost @ overweight/obese high cardiovascular risk patients , were used .


The relationship between total bilirubin level at screening and the primary outcome ( i.e. non-fatal myocardial infarction , non-fatal stroke , resuscitated cardiac arrest or cardiovascular death ) for the entire study period was investigated using Cox proportional hazards models .


The population was divided into four groups based on total bilirubin levels ( normal range @-@ mol/L ) .


Time-dependent Cox analyses were also performed to adjust for weight loss over time .


Initial analyses adjusted for sex , age and treatment allocation showed significantly reduced hazard ratios of @ ( @ % confidence interval @-@ @ ) , @ ( @-@ @ ) and @ ( @-@ @ ) , for the three higher total bilirubin groups : > @ and @ mol/L , > @ and @ mol/L and > @ mol/L ( @-@ interpercentile range for total bilirubin at screening ; @-@ mol/L ) , compared to the lowest total bilirubin group @ mol/L .


When adjusting for classical cardiovascular risk factors , estimates increased towards unity .


Additional adjustment for indicators of liver function did not alter the results .


A time-dependent Cox model , adjusted for weight loss , demonstrated a similar trend .


Bilirubin was not a risk-factor independent from other traditional cardiovascular risk-factors in our population .


This study investigated the effect of long-term niacin/laropiprant therapy on CV risk and IR in obese women with PCOS .


In this double-blind randomized placebo-controlled trial , @ and @ PCOS women completed a @week course of niacin/laropiprant or placebo , respectively .


Fasted subjects had an endothelial function test ( EndoPat@ ) and then consumed a mixed meal with blood sampled postprandially for @h before and after intervention .


By @weeks , niacin/laropiprant lowered low-density lipoprotein cholesterol ( LDL-c ) ( @ % ) and increased HDL-c ( @ % ) .


Despite a reduction in fasting triglycerides ( @ % ) , the drug had no effect on their postprandial rise ( @ vs. @ mmol/l , p = @ ) .


However , following the mixed meal , plasma glucose area under the response curve increased from @ to @ mmol/l , p = @ , as a consequence of both increased insulin resistance -LSB- HOMA-IR : @ ( @ , @ ) vs. @ ( @ , @ ) , p = @ -RSB- and a reduced acute insulin response to glucose -LSB- @ ( @ , @ ) vs. @ ( @ , @ ) pmol/mmol , p = @ -RSB- .


Niacin/laropiprant did not improve RHI ( @ vs. @ , p = @ ) or hsCRP .


In PCOS , niacin/laropiprant had a significant negative impact on postprandial glucose and no improvement in postprandial hypertriglyceridaemia , with at least the former mediated through increased IR and reduced - cell function .


This data may help explain why the improvement in fasting lipids has not translated into improved CV risk markers in PCOS .


Stressful events enhance risk for weight gain and adiposity .


Ghrelin and leptin , two hormones that are implicated in appetite regulation , may link stressful events to weight gain ; a number of rodent studies suggest that stressors increase ghrelin production .


The present study investigated the links among daily stressors , ghrelin and leptin , and dietary intake in humans .


Women ( n = @ ) completed three study appointments that were scheduled at least @ weeks apart .


At each visit , women arrived fasting and ate a standardized breakfast and lunch .


Blood samples were collected @min after each meal .


Women completed a self-report version of the Daily Inventory of Stressful Events ( DISE ) at each appointment .


Two composites were created from the DISE data , reflecting the number of stressors that did and did not involve interpersonal tension .


Women who experienced more stressors involving interpersonal tension had higher ghrelin and lower leptin levels than those who experienced fewer interpersonal stressors .


Furthermore , women who experienced more interpersonal stressors had a diet that was higher in calories , fat , carbohydrates , protein , sugar , sodium , and fiber , and marginally higher in cholesterol , vegetables ( but not fruits ) , vitamin A , and vitamin C. Stressors that did not involve interpersonal tension were unrelated to ghrelin and leptin levels or any of the dietary components examined .


These data suggest that ghrelin and leptin may link daily interpersonal stressors to weight gain and obesity .


comparative assessment of endoscopic and open exposure of the great saphenous vein during the operation of coronary artery bypass grafting .


a total of @ patients with endured coronary artery bypass graft operation were randomized depending on the method of exposing the great saphenous vein ( GSV ) - an open method of vein exposure ( OVE ) - @ patients and endoscopic vein exposure ( EVE ) - @ patients .


The evaluated parameters included healing of the postoperative wounds , postoperative oedema , pain intensity , and neuropathies in the early postoperative period .


We performed lymphoscintigraphy of the lower limbs , as well as morphological examination of the venous wall by means of light and electron scanning microscopy .


the duration of vein exposure was less in the EVE group than in the OVE group , amounting to @ @ min and @ @ min , respectively ( p < @ ) .


Complications after GSV isolation were encountered considerably less often in the EVE group ( @ % ) as compared to @ % in the OVE ( p = @ ) .


According to the results of the multivariate analysis , diabetes mellitus was the only risk factor for postoperative complications in OVE .


According the findings of lymphoscintigraphy the EVE group had no significant impairments of lymph outflow after the operation , whereas during OVE , accumulation of radiopaque material in the lymph nodes decreased twofold ( p @ ) .


Histological assessment of the sampled vein specimens showed no considerable lesions of the venous wall in the examined groups .


the obtained findings confirm high efficacy of using EVE during operations of CABG , lower traumaticity of this method with a conduit of good quality , which was proven based on electron microscopy of the vein fragments .


Patients receiving long-term oral anticoagulant therapy pose a clinical challenge during invasive dental procedures .


The goal of this study was to compare different local hemostatic modalities after tooth extraction in patients receiving chronic Vitamin-K antagonist therapy .


Totally @ patients with International Normalized Ratio ( INR ) @ requiring simple extraction of one or two teeth were randomized into three groups , @ patients in each group .


The patients with the mean INR value of @ @ , in whom extraction wound was sutured comprised the group A.


In the group B with the mean INR of @ @ , local hemostasis was achieved by placing absorbable gelatin sponges into the wound without suturing .


The group C consisted of the patients with the mean INR of @ @ in whom neither gelatin sponge nor suturing were used for providing local hemostasis .


Bleeding was registered as an event if other than initial hemostatic measure was needed or additional oral surgeon intervention required .


The obtainded results show that @ ( @ % ) patient in the group A , @ ( @ % ) patients in the groups B and C manifested post-extraction bleeding .


All cases of hemorrhage were easily solved with local hemostatic measures and all , except one case , were registered in the first two hours after the procedure until the dismissal .


A difference between the groups was not statistically significant ( @ = @ , p > @ ) .


In therapeutically anticoagulated patients tooth extractions can be safely performed without altering the dose of anticoagulant medication if efficient local hemostasis is provided .


In most cases ; in patients with INR @ after extraction of one or two teeth postoperative bleeding can be controlled with local pressure , without any additional local hemostatic measures .


A significant number of ovarian borderline tumors ( BOTs ) and metastatic nonovarian primaries are erroneously diagnosed as ovarian carcinomas .


If BOTs are misdiagnosed as cancer , patients may not only experience nonbeneficial morbidity but may have to cope with an incorrect diagnosis of cancer for the rest of their lives .


In cases of metastatic disease mistaken for an ovarian primary , more adequate therapeutic modalities may be withheld from some patients .


Finally , clinical trials may be biased through unintended disregard of histological inclusion criteria .


Patients were recruited for central pathology review according to a translational subprotocol of a prospectively randomized phase @ study led by the Arbeitsgemeinschaft Gynaekologische Onkologie ( AGO ) Study Group .


All original slides were requested , and a specialized central pathology review was performed by experienced gynecopathologists .


In cases of clinically relevant diagnostic discrepancies , the pathologist responsible for the original diagnosis was contacted .


If a given discrepancy could not be resolved , a panel of experts was involved for clarification .


Four hundred fifty-four patients with an original diagnosis of ovarian , tubal , or peritoneal epithelial carcinoma were recruited .


In @ % ( @ patients ) , a major diagnostic discrepancy of clinical relevance was found .


Most frequently ( @ patients ) , serous BOT had been misdiagnosed as invasive cancer .


Ovarian metastases constituted the second most frequent misdiagnosis ( @ patients ) .


Minor discrepancies not affecting patient treatment were found in @ % ( @ patients ) .


Specialized central pathology review could help to avoid overtreatment of patients with BOT and inappropriate treatment of patients with ovarian metastases .


The implementation of a specialized case review process may translate into enhanced patient safety in clinical trials of ovarian carcinomas .


Furthermore , central pathology review may increase the rigor and ultimately the transferability of clinical research into practice and should therefore become a standard procedure in study protocols evaluating new therapies .


Latino immigrants have high rates of obesity and face barriers to weight loss .


To evaluate the effectiveness of a case-management ( CM ) intervention with and without community health workers ( CHWs ) for weight loss .


This was a @-year , randomized controlled trial comparing two interventions with each other and with usual care ( UC ) .


Eligible participants included Latinos with a body mass index of @ to @ and one or more heart disease risk factors .


The @ participants recruited during @-@ had a mean age of @ years and were mostly women ( @ % ) .


At @ months , @ % of the sample was assessed .


The CM+CHW ( n = @ ) and CM ( n = @ ) interventions were compared with each other and with UC ( n = @ ) .


Both included an intensive @-month phase followed by @ months of maintenance .


The CM+CHW group received home visits .


Weight change at @ months .


Generalized estimating equations using intent-to-treat .


At @ months , mean weight loss in the CM+CHW arm was -@ kg ( @ % CI -@ to -@ ) or -@ % of baseline weight ( @ % CI -@ % to -@ % ) compared with -@ kg ( @ % CI -@ to -@ ; % weight change , -@ % , -@ % , and -@ % ) in CM and -@ kg ( @ % CI -@ to @ ; % weight change , -@ % , @ % , and -@ % ) in UC .


By @ and @ months , differences narrowed and CM+CHW was no longer statistically distinct .


Men achieved greater weight loss than women in all groups at each time point ( P < @ ) .


At @ months , men in the CM+CHW arm lost more weight ( -@ kg ; @ % CI -@ to -@ ) compared with UC ( -@ kg ; @ % CI -@ to @ ) , but by @ and @ months differences were not significant .


This study demonstrated that incorporation of CHWs may help promote initial weight loss , especially among men , but not weight maintenance .


Additional strategies to address social and environmental influences may be needed for Latino immigrant populations .


Heavy drinking is common during transitions from high school to college .


Optimal programs for diminishing risks for high alcohol consumption often tailor the approach to the specific needs of students .


This study describes the results of an Internet-based prevention protocol that tailors the information to the risk associated with a pre-existing phenotype , the Low level of Response ( Low LR ) to alcohol .


Using stratified random assignment , @ freshmen with Low and High LR values were assigned to @ education groups ( LR-based where all examples were given the context of the Low LR model of heavy drinking or a State Of The Art ( SOTA ) Group where the same lessons were taught but without an emphasis on LR ) or a no-intervention Control Group .


Individuals in the @ education groups viewed @-minute online videos once per week for @weeks .


Changes in drinking patterns were assessed at Baseline , @weeks , and @weeks using a @ ( LR status ) by @ ( education group ) by @ ( time points ) analysis of variance , with additional tests for ethnicity and sex .


Low LR participants tended to decrease their usual ( p < @ ) and maximum ( p < @ ) drinks per occasion most prominently when assigned to the LR-based protocol , while those with High LRs improved more in the SOTA Group .


The most robust differences were seen when controlling for ethnicity .


The effect sizes were small to medium .


These results support the advantages of carrying out prevention via the Internet and in tailoring the approach to a pre-existing phenotype .


This paper describes the pharmacokinetic/pharmacodynamic modelling of clazosentan in patients with aneurysmal subarachnoid haemorrhage ( aSAH ) , and the impact of collecting data in an intensive care unit ( ICU ) setting .


Factors influencing data quality , analysis , and interpretation are provided with recommendations for future clinical studies in ICU settings .


CONSCIOUS-@ was a phase III study involving @,@ patients with aSAH .


Secured by surgical clipping , patients were infused with clazosentan or placebo for up to @ days post-aSAH .


Clazosentan exposure relationships with vital signs , QT intervals , and AST/ALT values as well as efficacy and safety endpoints were characterised using population PK/PD and logistic regression models .


Clazosentan clearance was influenced by age , sex , Asian origin , and disease status at baseline , and increased with time .


Volume of distribution showed a sex difference .


Exposure had no relationship with any efficacy endpoint or ALT/AST values , but was related to the increasing probability of lung complications .


Blood pressure decreased proportionally to clazosentan concentrations , and the presence of clazosentan was associated with QT interval increases .


Implausible values in the concentration data reflect the specific ICU challenges , possibly arising from PK sampling from the infusion arm or haemodilution .


Population PK/PD modelling of CONCIOUS-@ data provided clinically relevant knowledge about various effects of clazosentan in the aSAH patient population in a real clinical setting .


The quality of data and analyses could be improved by the collection of additional data and stricter training of study personnel .


Differences in clinical practice between sites and geographical regions are more challenging to overcome .


Anthracyclines and taxanes have been the standard neoadjuvant chemotherapies for breast cancer in the past decade .


We aimed to assess safety and efficacy of the addition of gemcitabine to accelerated paclitaxel with epirubicin and cyclophosphamide , and also the effect of sequencing the blocks of epirubicin and cyclophosphamide and paclitaxel ( with or without gemcitabine ) .


In our randomised , open-label , @ factorial phase @ trial ( Neo-tAnGo ) , we enrolled women ( aged > @ years ) with newly diagnosed breast cancer ( tumour size > @ mm ) at @ centres in the UK .


Patients were randomly assigned via a central randomisation procedure to epirubicin and cyclophosphamide then paclitaxel ( with or without gemcitabine ) or paclitaxel ( with or without gemcitabine ) then epirubicin and cyclophosphamide .


Four cycles of each component were given .


The primary endpoint was pathological complete response ( pCR ) , defined as absence of invasive cancer in the breast and axillary lymph nodes .


This study is registered with EudraCT ( @-@-@ ) , ISRCTN ( @ ) , and ClinicalTrials.gov ( NCT@ ) .


Between Jan @ , @ , and Sept @ , @ , we randomly allocated @ participants ; @ received epirubicin and cyclophosphamide then paclitaxel ; @ were given paclitaxel then epirubicin and cyclophosphamide ; @ had epirubicin and cyclophosphamide followed by paclitaxel and gemcitabine ; and @ received paclitaxel and gemcitabine then epirubicin and cyclophosphamide .


@ patients were eligible for analysis .


Median follow-up was @ months ( IQR @-@ ) .


@ ( @ % ) patients had inflammatory or locally advanced disease , @ ( @ % ) patients had tumours larger than @ mm , @ ( @ % ) patients had clinical involvement of axillary nodes , @ ( @ % ) patients had oestrogen receptor ( ER ) - negative disease , and @ ( @ % ) patients had HER@-positive disease .


Addition of gemcitabine did not increase pCR : @ ( @ % , @ % CI @-@ ) of @ patients in the epirubicin and cyclophosphamide then paclitaxel group achieved pCR compared with @ ( @ % , @-@ ) of @ patients who received additional gemcitabine ( p = @ ) .


Receipt of a taxane before anthracycline was associated with improved pCR : @ ( @ % , @ % CI @-@ ) of @ patients who received paclitaxel with or without gemcitabine followed by epirubicin and cyclophosphamide achieved pCR compared with @ ( @ % , @-@ ) of @ patients who received epirubicin and cyclophosphamide first ( p = @ ) .


Grade @ toxicities were reported at expected levels : @ ( @ % ) of @ patients who received treatment and had full treatment details had grade @ neutropenia , @ ( @ % ) had infection , @ ( @ % ) had fatigue , @ ( @ % ) had muscle and joint pains , @ ( @ % ) had nausea , @ ( @ % ) had vomiting , @ ( @ % ) had neuropathy , @ ( @ % ) had transaminitis , @ ( @ % ) had acute hypersensitivity , and @ ( @ % ) had a rash .


@ ( @ % ) patients had grade @ neutropenia and @ ( < @ % ) had grade @ infection .


Although addition of gemcitabine to paclitaxel and epirubicin and cyclophosphamide chemotherapy does not improve pCR , sequencing chemotherapy so that taxanes are received before anthracyclines could improve pCR in standard neoadjuvant chemotherapy for breast cancer .


To compare the effects of intranasal application of black seed ( Nigella Sativa ) oil ( NSO ) and isotonic sodium chloride solution ( ISCS ) on nasal symptoms of the elderly .


In this prospective , crossover randomized controlled trial , @ geriatric patients with nasal dryness and related symptoms were randomized to receive either @ weeks of isotonic sodium chloride solution ( ISCS ) followed by @ weeks of N. sativa oil ( NG oil ) or the same treatment in the opposite order .


There was a washout period of @ weeks in between the treatment periods .


Subjective symptoms including nasal dryness , burning , obstruction , itching and crusting were evaluated by a visual analog scale .


Mucociliary function was evaluated with saccharin test .


Nasal dryness , obstruction and crusting improved significantly with the use of NSO compared to ISCS without any evidence of relevant carryover effects ( p < @ for all for the difference in treatment ) .


There was no significant difference between the effect of NSO and ISCS on nasal burning and itching ( p > @ for all ) .


There was no change in mucociliary clearance during any of the treatment periods .


NSO is a better alternative to ISCS to treat nasal mucosa symptoms due to aging .


To determine the relationship of glycated albumin ( GA ) and the recurrence of stroke in patients on either dual or single antiplatelet therapy .


The Clopidogrel in High-Risk Patients with Acute Nondisabling Cerebrovascular Events trial randomized minor ischemic stroke or TIA patients to antiplatelet therapy of clopidogrel plus aspirin or aspirin alone .


A subgroup of @,@ consecutive patients with baseline GA levels from @ ( @ % ) prespecified clinical sites was analyzed .


Patients were categorized into @ groups based on GA level of @ % , the cut point for development of diabetes .


The primary outcome was stroke recurrence during @-day follow-up .


Cox proportional hazards models were used to assess the interaction of GA with randomized antiplatelet therapy on their risk of recurrent stroke .


Significant interaction of GA levels with the @ antiplatelet therapy groups was found after adjustment for age , sex , and other conventional confounding factors ( p = @ ) .


The interaction remained consistent after further adjustment for history of diabetes ( p = @ ) .


In patients with lower GA level , stroke occurred in @ % of patients in the clopidogrel-aspirin group , and @ % in the aspirin group ( adjusted hazard ratio -LSB- HR -RSB- @ ; @ % confidence interval -LSB- CI -RSB- @-@ @ ; p < @ ) .


Furthermore , in patients with elevated GA level , stroke occurred in @ % of patients in the clopidogrel-aspirin group , and @ % in the aspirin group ( adjusted HR @ ; @ % CI @-@ @ ; p = @ ) .


GA could be a potential biomarker to predict the effects of dual and single antiplatelet therapy in patients with minor stroke or TIA .


This study aimed to evaluate the validity and reliability of the Multidimensional Body Image Scale ( MBIS ) , a seven-factor , @-item scale developed for Malaysian female adolescents .


This scale was evaluated among male and female Malaysian university students .


A total of @ university students ( @ % women and @ % men ) completed a self-administered questionnaire on MBIS , Eating Attitude Test-@ , and Rosenberg Self-Esteem Scale .


Their height and weight were measured .


Results in confirmatory factor analysis showed that the @-item MBIS reported poor fit to the data , xhi@/df = @ , p < @ , CFI = @ , SRMR = @ , RMSEA = @ ( @ % CI = @ , @ ) .


After re-specification of the model , the model fit was improved with @ items remaining , chi@/df = @ , p < @ , CFI = @ , SRMR = @ , RMSEA = @ ( @ % CI = @ , @ ) , and the model showed good fit to the data for men and women separately .


This @-item MBIS had good internal consistency in both men ( Cronbach 's alpha = @ ) and women ( Cronbach 's alpha = @ ) .


In terms of construct validity , it showed positive correlations with disordered eating and body weight status , but negative correlation with self-esteem .


Also , this scale discriminated well between participants with and without disordered eating .


The MBIS-@ demonstrated good reliability and validity for the evaluation of body image among university students .


Further studies need to be conducted to confirm the validation results of the @-item MBIS .


To explore the effect of Qiling Decoction ( QD ) combined highly active antiretroviral treatment ( HAART ) on expression levels of peripheral blood Th@ and Treg cells in HIV/AIDS patients .


Totally @ HIV/AIDS patients were randomly assigned to the treatment group ( @ cases ) and the combination group ( @ cases ) .


Besides , @ HIV negative patients were recruited as the healthy control group .


Those in the treatment group received HARRT alone , while those in the combination group received HAART combined QD .


The observation lasted for @ weeks .


Meanwhile , according to peripheral blood CD@ + T cell counts before treatment , HIV/AIDS patients were assigned to three subgroups .


For patients in subgroup @ , @ cells/microL < CD@ + T cell counts < or = @ cells/microL ; For patients in subgroup @ , @ cells/microL < CD@ + T cell counts < or = @ cells/lL ; For patients in subgroup @ , @ cells/microL < CD@ + T cell counts < or = @ cells/microL .


Expression of peripheral blood Th@ and Treg cells , and number of CD@ + T cell counts were detected using flow cytometry ( FCM ) in HIV/AIDS patients at the pre-treatment baseline , week @ , @ , and @ , as well as those in the healthy control group .


Compared with the healthy control group , CD@ + T cell counts and the baseline expression level of Th@ cells in the peripheral blood of HIV/AIDS patients significantly decreased , the expression level of Treg cells significantly increased P < @ ) .


Compared with before treatment in the same group , CD@ + T cell counts all increased at week @ , @ , and @ in the two treatment groups , showing statistical difference ( P < @ , P < @ ) .


There was no statistical difference in the effective rate at various CD@ + T cell levels between the two groups ( P > @ ) .


There was no statistical difference in expression levels of Th@ and Treg cells between the combination group and the treatment group at any time point ( all P > @ ) .


The Th@/Treg ration significantly increased in the combination group after @ weeks of treatment , showing statistical difference when compared with the treatment group ( U = @ , P = @ ) .


QD could improve the immune balance of Th@/Treg cells , which might be one of its mechanisms for improving HIV/AIDS patients ' immunity .


Trimethoprim-sulfamethoxazole prophylaxis is recommended for HIV-exposed infants until breastfeeding ends and HIV infection has been excluded .


Extending prophylaxis with a focus on preventing malaria may be beneficial in high transmission areas .


We investigated three regimens for the prevention of malaria in young HIV-exposed children .


An open-label , randomized controlled trial .


Tororo , Uganda , a rural area with intense , year-round , malaria transmission .


Two hundred infants aged @-@ months enrolled and @ randomized after cessation of breastfeeding and confirmed to be HIV uninfected ( median @ months of age ) .


No chemoprevention , monthly sulfadoxine-pyrimethamine , daily trimethoprim-sulfamethoxazole or monthly dihydroartemisinin-piperaquine given from randomization to @ months of age .


The primary outcome was the incidence of malaria during the intervention period .


Secondary outcomes included the incidence of hospitalization , diarrhoeal illness , or respiratory tract infection ; prevalence of anaemia and asymptomatic parasitemia ; measures of safety ; and incidence of malaria over @ year after the intervention was stopped .


During the intervention , the incidence of malaria in the no chemoprevention group was @ episodes per person-year at risk .


Protective efficacy was @ % -LSB- @ % confidence interval ( @ % CI ) @-@ , P < @ -RSB- for dihydroartemisinin-piperaquine , @ % ( @ % CI @-@ , P = @ ) for trimethoprim-sulfamethoxazole and @ % for sulfadoxine-pyrimethamine ( @ % CI -@ to @ , P = @ ) .


There were no significant differences in any secondary outcomes , with the exception of a lower prevalence of asymptomatic parasitemia in the dihydroartemisinin-piperaquine arm .


Monthly chemoprevention with dihydroartemisinin-piperaquine was well tolerated and associated with a significant reduction in malaria in young HIV-exposed children .


To compare the outcome of fornix-based trabeculectomy with mitomycin C ( MMC ) using @ different sizes of subconjunctival preparation ( @ mm compared with @ mm ) .


Prospective , randomized interventional case series .


Patients @ to @ years of age with open-angle glaucoma and progressive visual field defects under maximum tolerated medical therapy were randomized to undergo initial fornix-based trabeculectomy with MMC ( @ mg/mL for @ min ) with subconjunctival preparation of @ mm ( group A ) or @ mm ( group B ) .


Main outcome parameters were : intraocular pressure ( IOP ) , best-corrected visual acuity ( BCVA ) , number of @-fluorouracil ( @-FU ) injections , and laser suturolyses ( SL ) .


Twenty-eight eyes of @ patients were enrolled , including @ eyes in group A and @ in group B.


At @ months , IOP ( meanSD ) was @ mm Hg in group A and @ mm Hg in group B ( P = @ ) without glaucoma medication .


Mean BCVA ( logMAR ) at month @ was @ in group A and @ in group B ( P = @ ) .


Patients required @ @-FU in group A and @ @-FU in group B ( P = @ ) ; @ SL and @ SL , respectively ( P = @ ) .


We noted @ cases of intraocular hypotony in the @ mm group ( @ % ) and @ in the @ mm group ( @ % ) .


There were no significant differences between study groups in mean IOP reduction , change in BCVA , or number of applied @-FU and SL at @-year follow-up .


The area of subconjunctival preparation is only one of several factors playing a role in the outcome of trabeculectomy with MMC .


To compare the postoperative analgesic characteristics and side effects of two different doses of intrathecal dexmedetomidine in combination with hyperbaric bupivacaine , and to evaluate the effects of these combinations on spinal anesthesia .


After obtaining approval from the local ethics committee , @ male patients who were undergoing inguinal surgery and were classified as American Society of Anesthesiologists physical status class I were included in the study .


The present study was conducted in @ in a military hospital with a capacity of @ beds .


The patients were randomly assigned to three groups of @ patients : group @ , @ mL saline added to @ mL ( @ mg ) hyperbaric bupivacaine ; and groups @ and @ , @ g dexmedetomidine and @ g dexmedetomidine added to @ mL ( @ mg ) hyperbaric bupivacaine , respectively .


Medications were administered by intrathecal injection in a total volume of @ mL .


The postoperative analgesic characteristics , effects on spinal anesthesia and side effects were recorded .


Demographic characteristics were similar among the groups .


The mean ( SD ) time to onset of pain was @ min in group @ , @ min in group @ and @ min in group @ .


Time to first pain sensation in group @ was significantly longer than that in groups @ and @ ( P < @ ) .


Two different doses of dexmedetomidine , an @-adrenoceptor agonist with analgesic effects , resulted in an increased duration of analgesia and efficacy , decreased postoperative analgesic use and was associated with no notable adverse effects .


New technologies have recently been used for monitoring signs and symptoms of mental health illnesses and particularly have been tested to improve the outcomes in bipolar disorders .


Web-based psychoeducational programs for bipolar disorders have also been implemented , yet to our knowledge , none of them have integrated both approaches in one single intervention .


The aim of this project is to develop and validate a smartphone application to monitor symptoms and signs and empower the self-management of bipolar disorder , offering customized embedded psychoeducation contents , in order to identify early symptoms and prevent relapses and hospitalizations .


The project will be carried out in three complementary phases , which will include a feasibility study ( first phase ) , a qualitative study ( second phase ) and a randomized controlled trial ( third phase ) comparing the smartphone application ( SIMPLe ) on top of treatment as usual with treatment as usual alone .


During the first phase , feasibility and satisfaction will be assessed with the application usage log data and with an electronic survey .


Focus groups will be conducted and technical improvements will be incorporated at the second phase .


Finally , at the third phase , survival analysis with multivariate data analysis will be performed and relationships between socio-demographic , clinical variables and assessments scores with relapses in each group will be explored .


This project could result in a highly available , user-friendly and not costly monitoring and psychoeducational intervention that could improve the outcome of people suffering from bipolar disorders in a practical and secure way .


Standard print and verbal information provided to patients undergoing treatments are often difficult to understand and may impair their ability to be truly informed .


This study examined the effect of an interactive multimedia informational program with in-line exercises and corrected feedback on patients ' real-time understanding of their cardiac catheterization procedure .


@ adult patients scheduled for diagnostic cardiac catheterization were randomized to receive information about their procedure using either the standard institutional verbal and written information ( SI ) or an interactive iPad-based informational program ( IPI ) .


Subject understanding was evaluated using semi-structured interviews at baseline , immediately following catheterization , and @ weeks after the procedure .


In addition , for those randomized to the IPI , the ability to respond correctly to several in-line exercises was recorded .


Subjects ' perceptions of , and preferences for the information delivery were also elicited .


Subjects randomized to the IPI program had significantly better understanding following the intervention compared with those randomized to the SI group ( @ vs @ , respectively , @-@ scale where @ = complete understanding , P < @ ) .


First-time correct responses to the in-line exercises ranged from @ % to @ % .


Subjects reported that the in-line exercises were very helpful ( @ , @-@ scale , where @ = extremely helpful ) and the iPad program very easy to use ( @ , @-@ scale , where @ = extremely easy ) suggesting good clinical utility .


Results demonstrated the ability of an interactive multimedia program to enhance patients ' understanding of their medical procedure .


Importantly , the incorporation of in-line exercises permitted identification of knowledge deficits , provided corrected feedback , and confirmed the patients ' understanding of treatment information in real-time when consent was sought .


Compared with younger patients , older adults with acute myeloid leukemia ( AML ) generally have poorer survival outcomes and less benefit from clinical trials .


A recent phase @ trial demonstrated a trend toward improved overall survival ( OS ) with decitabine , a hypomethylating agent , compared with treatment choice of either cytarabine or supportive care ( @ months , @ % CI : @-@ @ vs @ months , @ % CI : @-@ @ , respectively ) in older adults with newly diagnosed AML .


The current analyses investigated prognostic factors for outcomes in this trial and examined OS and responses in prespecified subgroups .


A multivariate Cox proportional hazards model was used to investigate effects of demographic and baseline characteristics , including age , sex , cytogenetic risk , AML type , ECOG Performance Status , geographic region , bone marrow blasts , platelets , and white blood cells on OS , based on mature data .


Similar analyses were conducted with a logistic regression model to predict response rates .


Prespecified subgroup analyses were performed for OS and response rates , also using mature data .


Patient characteristics that appeared to negatively influence OS included more advanced age ( hazard ratio -LSB- HR -RSB- @ for @ vs < @ years ; p = @ ) , poorer performance status at baseline ( HR @ for @ or @ vs @ ; p = @ ) , poor cytogenetics ( HR @ for intermediate vs poor ; p = @ ) , higher bone marrow blast counts ( HR @ for > @ % vs @ % ; p = @ ) , low baseline platelet counts ( HR @ for each additional @ @/L ; p = @ ) , and high white blood cell counts ( HR @ for each additional @ @/L ; p = @ ) .


Regarding geographic regions , patients from Western Europe had the longest median OS .


Response rates favored decitabine for all subgroups investigated , including patients @ years ( odds ratio @ , p = @ ) .


Response to decitabine in AML is associated with known prognostic factors related to both patient demographics and disease characteristics .


We present the @-year results of the GOLIATH prospective randomized controlled trial comparing transurethral resection of the prostate to GreenLight XPS for the treatment of men with nonneurogenic lower urinary tract symptoms due to prostate enlargement .


The updated results at @ year show that transurethral resection of the prostate and GreenLight XPS remain equivalent , and confirm the therapeutic durability of both procedures .


We also report @-year followup data from several functional questionnaires ( OABq-SF , ICIQ-SF and IIEF-@ ) and objective assessments .


A total of @ patients were enrolled at @ sites in @ European countries .


Patients were randomized @:@ to undergo GreenLight XPS or transurethral resection of the prostate .


The trial was designed to evaluate the hypothesis that GreenLight XPS is noninferior to transurethral resection of the prostate on the International Prostate Symptom Score at @ months .


Several objective parameters were assessed , including maximum urinary flow rate , post-void residual urine volume , prostate volume and prostate specific antigen , in addition to functional questionnaires and adverse events at each followup .


Of the @ enrolled patients @ were randomized and @ received treatment .


Noninferiority of GreenLight XPS was maintained at @ months .


Maximum urinary flow rate , post-void residual urine volume , prostate volume and prostate specific antigen were not statistically different between the treatment arms at @ months .


The complication-free rate at @ year was @ % after GreenLight XPS vs @ % after transurethral resection of the prostate .


At @ months @ patients treated with GreenLight XPS and @ who underwent transurethral resection of the prostate had unresolved urinary incontinence .


Followup at @ year demonstrated that photoselective vaporization of the prostate produced efficacy outcomes similar to those of transurethral resection of the prostate .


The complication-free rates and overall reintervention rates were comparable between the treatment groups .


To investigate the dynamics of behavioral indicators , attention and memory in children with attention deficit hyperactivity disorder ( ADHD ) treated with noofen ( capsules @ mg ) .


In an open study , @ patients were randomized to @ equal groups : patients of group @ were treated with noofen ( @-@ mg/kg ( @-@ mg ) per day perorally in @-@ doses ) ; the control group received low doses of multivitamins .


Duration of treatment was one month .


The results of neuropsychological testing revealed the improvement of cognitive functions , including the indicators of self-control , sustained , directed and divided attention , acoustic-verbal memory , to the end of treatment .


The initial positive changes may be the basis for obtaining better clinical results during long-term treatment .


Occurrence of atrial fibrillation after cardiac surgery is associated with long-term mortality .


We investigated whether infusion of human atrial natriuretic peptide ( carperitide ) could prevent postoperative atrial fibrillation .


A total of @ patients who underwent isolated coronary artery bypass grafting were randomized to receive infusion of carperitide or physiological saline from the initiation of cardiopulmonary bypass .


Patients were monitored continuously for @ week after surgery to detect atrial fibrillation .


The risk factors were investigated by Cox proportional hazard model .


Postoperative atrial fibrillation occurred in @ of @ patients ( @ % ) from the carperitide group versus @ of @ patients ( @ % ) from the placebo group ( P < @ ) .


Postoperative levels of angiotensin-II , aldosterone , creatine kinase MB isoenzyme , human heart fatty acid-binding protein , and brain natriuretic peptide were all significantly lower in the carperitide group .


The risk factors for postoperative atrial fibrillation by the Cox proportional hazard model were an age @ years , emergency surgery , preoperative aldosterone level > @ ng/mL , preoperative nonuse of angiotensin receptor antagonists , preoperative use of calcium antagonists , postoperative nonuse of - blockers , postoperative nonuse of aldosterone blockers , and nonuse of carperitide .


- Perioperative carperitide infusion reduced the occurrence of postoperative atrial fibrillation .


Accordingly , carperitide could be a useful option for preventing postoperative atrial fibrillation .


To explore the curative effect of nasal type extranodal NK/T-cell lymphoma by sequential chemotherapy combined radiotherapy compared with chemtherapy .


Fifty-seven cases of nasal type extranodal NK/T-cell lymphoma confirmed by pathological morphology and immuno-histochemistry were divided into chemotherapy combined radiotherapy group ( @ cases ) or chemotherapy group ( @ cases ) .


Twenty-three patients in the chemotherapy group alternately applied CHOP , VDLP and MEOP regimen after each two treatments into the clinical observation ; Chemotherapy combined radiotherapy group of @ patients , in addition to the above chemotherapy , applied three-dimensional conformal radiation therapy of the primary site by linear accelerators .


Then all of patients were ceased treatment and followed up @-@ years .


( @ ) After treatment , effective rate of two groups was @ % and @ % , there was no obvious difference ( P > @ ) ; After follow up about @ year , effective rate of two groups was @ % and @ % , there was no obvious difference ( P > @ ) ; ( @ ) After follow up about @ years and @ years , disease free survival ( DFS ) of two groups was @ % , @ % and @ % , @ % , there was obvious difference ( P < @ ) .


( @ ) Long-term survival is closely related to treatment mode .


( @ ) B symptoms , advanced ( III , IV ) stage , the International Prognostic Index ( IPI ) , KPS scores were correlated with prognosis , and were independent prognostic factors .


Treatment with chemotherapy and radiotherapy for nasal type extranodal NK/T-cell lymphoma had obvious curative effect and may improve long-term survival efficiently compared with chemotherapy alone .


Antiviral drugs are a proposed medical intervention to reduce household transmission of influenza viruses .


In a previously described randomised , placebo-controlled trial in Dhaka , Bangladesh , we showed that oseltamivir treatment of index patients was able to reduce influenza symptom duration and virus shedding .


In a further analysis that is part of the same study , we aimed to assess efficacy of oseltamivir to reduce secondary household illnesses in the same cohort .


In this double-blind oseltamivir efficacy trial , we identified index patients aged older than @ year through surveillance of households in Dhaka , Bangladesh .


We randomly allocated eligible patients ( @:@ ) to receive oseltamivir or placebo twice-daily for @ days , and we stratified them by enrolment @ h versus @-@ h since illness onset .


Participants provided nasal wash specimens at enrolment and @ , @ , and @ days after enrolment and were visited daily by a research assistant to record symptoms , both in index patients and in household members .


For this part of the study , household members were asked to give respiratory specimens for influenza PCR testing .


Our primary outcomes were household secondary illness and PCR-confirmed influenza virus infection , assessed in household members of all randomly allocated index patients .


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


From May @ , @ , to Dec @ , @ , we enrolled @ index patients with @ household members .


@ patients were allocated to placebo ( @ household members ) and @ to oseltamivir ( @ household members ) .


Household secondary illness was lower in the oseltamivir group ( @ -LSB- @ % -RSB- influenza cases ) than in the placebo group ( @ -LSB- @ % -RSB- ; odds ratio -LSB- OR -RSB- @ , @ % CI @-@ , p = @ ) .


PCR-confirmed influenza virus infection did not differ between the placebo ( @ -LSB- @ % -RSB- ) and oseltamivir groups ( @ -LSB- @ % -RSB- ; @ , @-@ , p = @ ) ; however , only @ ( @ % ) of ill household members gave a specimen for analysis .


In a crowded , low income setting , oseltamivir treatment of index patients resulted in a small reduction of secondary influenza in their households .


Even this slight reduction , in the setting of widespread antiviral use during a community influenza outbreak , might result in reductions in overall disease burden .


Mobile applications on smartphones can communicate a large amount of personalized , real-time health information , including advice on skin cancer prevention , but their effectiveness may be affected by whether recipients can be convinced to use them .


To evaluate a smartphone mobile application ( Solar Cell ) delivering real-time advice about sun protection for a second time in a randomized clinical trial .


A previous trial conducted in @ used a randomized pretest-posttest design .


For the present trial , we collected data from a volunteer sample of @ adults @ years or older who owned a smartphone .


Participants were recruited nationwide through online promotions .


Screening procedures and a @-week run-in period were added to increase the use of the mobile application .


We conducted follow-ups at @ and @ weeks after randomization to examine the immediate and the longer-term effects of the intervention .


Use of the mobile application .


The application gave feedback on sun protection ( ie , sun-safety practices and the risk for sunburn ) and alerted users to apply or to reapply sunscreen and to get out of the sun .


The application also displayed the hourly UV Index and vitamin D production based on the forecast UV Index , time , and location .


Percentage of days with the use of sun protection , time spent outdoors in the midday sun ( days and hours ) , and the number of sunburns in the last @ months .


Participants in the intervention group used wide-brimmed hats more at @ weeks than control participants ( @ % vs @ % ; F = @ ; P = @ ) .


Women who used the mobile application reported using all sun protection combined more than men ( @ % vs @ % ; F = @ ; P = @ ) , whereas men and older individuals reported less use of sunscreen ( @ % vs @ % ; F = @ ; P = @ ) and hats ( @ % vs @ % ; F = @ ; P = @ ) .


The mobile application initially appeared to confer weak improvement of sun protection .


Use of the mobile application was greater than in a previous trial and was associated with greater sun protection , especially among women .


Strategies to increase the use of the mobile application are needed if the application is to be deployed effectively to the general adult population .


Internet-based Smoking Cessation Interventions could help pregnant women quit smoking , especially those who do not wish to , or can not , access face-to-face or telephone support .


This study aimed to preliminarily evaluate the effectiveness and usage of a fully automated smoking cessation website targeted to pregnancy , ` MumsQuit ' , and obtain an initial effect-size estimate for a full scale trial .


We recruited @ UK-based pregnant adult smokers online to a two-arm double-blind pilot RCT assessing the effectiveness of MumsQuit compared with an information-only website .


MumsQuit was adapted from a generic internet smoking cessation intervention , ` StopAdvisor ' .


The primary outcome was self-reported continuous @-week abstinence assessed at @ weeks post-baseline .


Secondary outcomes were automatically collected data on intervention usage .


Participants smoked @ cigarettes per day on average , @ % were in the first trimester of their pregnancy , @ % were from lower socioeconomic backgrounds , and @ % had never used evidence-based cessation support .


The point estimate of odds ratio for the primary outcome was @ ( @ % CI = @-@ @ ; @ % vs. @ % ) .


Compared with control participants , those in the MumsQuit group logged in more often ( @ vs. @ , p < @ ) , viewed more pages ( @ vs. @ , p < @ ) and spent more time browsing the website ( @ min vs. @ min , p < @ ) .


MumsQuit is an engaging and potentially helpful form of support for pregnant women who seek cessation support online , and merits further development and evaluation in a full-scale RCT .


Acute bronchiolitis is the most frequent lower respiratory tract infection in infants , yet there are no effective therapies available .


Current evidence is unclear about the role of hypertonic saline ( HS ) for the acute treatment of bronchiolitis .


To determine whether nebulized @ % HS compared with normal saline ( NS ) improves respiratory distress in infants with bronchiolitis not responding to standard treatments in the emergency department .


A randomized clinical trial with blinding of investigators , health care providers , and parents was conducted at a single urban pediatric ED .


The participants included children aged @ to less than @ months with their first episode of bronchiolitis and a Respiratory Distress Assessment Instrument score of @ to @ after nasal suctioning and a trial of nebulized albuterol .


Patients were randomized to receive either nebulized @ % HS ( HS group ) or NS ( NS group ) .


The primary outcome was change in respiratory distress at @ hour after the intervention , as measured by the Respiratory Assessment Change Score ( a decrease indicates improvement ) .


Secondary outcomes included vital signs , oxygen saturation , hospitalization , physician clinical impression , parental assessment , and adverse events .


The @ patients enrolled in each treatment arm had similar baseline demographic and clinical characteristics .


At @ hour after the intervention , the HS group demonstrated significantly less improvement in the median Respiratory Assessment Change Score compared with the NS group ( HS , -@ -LSB- interquartile range , -@ to @ -RSB- vs. NS , -@ -LSB- interquartile range , -@ to -@ -RSB- ; P = @ ) .


There were no significant differences in heart rate , oxygen saturation , hospitalization rate , or other outcomes .


There were no adverse events .


Infants with bronchiolitis and persistent respiratory distress after standard treatment in the emergency department had less improvement after receiving @ % HS compared with those who received NS .


Based on these results and the existing evidence , administration of a single dose of @ % HS does not appear to be indicated to treat bronchiolitis in the acute care setting .


This study aimed to assess the efficacy and safety of our newly developed nasal glucagon-like peptide-@ ( GLP-@ ) compound and injector .


Twenty-six patients with type @ diabetes were enrolled in this double-blind placebo-controlled study .


The nasal compound containing @ mg of human GLP-@ ( @-@ ) amide or placebo was administered immediately before every meal for @ weeks .


The plasma peak concentration of active GLP-@ was @ pmol/L , and its Tmax was @ min .


The early phase of insulin and glucagon secretion were recovered and suppressed , respectively , in the GLP-@ group .


Glycoalbumin levels became significantly lower and @,@-anhydroglucitol levels significantly higher after GLP-@ administration .


No marked adverse events were observed after using nasal GLP-@ .


The newly developed nasal GLP-@ compound may be a potential treatment for type @ diabetes .


The long-term application of the drug should be evaluated in future trials .


Effective wound closure is critical to minimizing wound complications and withstanding the forces associated with early knee motion after TKA .


Barbed sutures allow for knotless fixation , have been used successfully in other specialties , and may provide for more even distribution of tension along the length of the incision ; however , data regarding unidirectional barbed sutures from randomized trials have raised important concerns about their use .


Bidirectional barbed sutures offer a potential alternative , but have not been studied extensively in orthopaedic surgery .


Using a prospective , randomized , within-patient controlled study design I compared wound closure performed with bidirectional barbed sutures in one knee of bilateral TKAs performed under the same anesthetic with those performed with standard sutures in the other knee to determine whether the barbed suture was associated with ( @ ) faster closure times ; ( @ ) fewer intraoperative suture issues , such as needle sticks or suture breakage , and fewer postoperative wound complications ; ( @ ) no detrimental effect on clinical outcomes , including knee ROM and Knee Society scores ; and ( @ ) lower total operative cost , considering suture material cost and operating room time savings .


Between @ and @ , @ consecutive patients meeting prespecified inclusion criteria with simultaneous bilateral TKAs had deep and superficial closures performed using interrupted and running standard sutures in one randomly assigned knee , and running knotless bidirectional barbed sutures in the other knee .


The barbed suture is US FDA-approved for soft tissue approximation wherever absorbable sutures are appropriate .


Intraoperative suture issues and the number of sutures used were recorded at the time of wound closure .


Suture cost was compared between the standard and barbed sutures and measured against the operative time cost , as estimated per minute saved .


Patients were followed postoperatively at @ , @ , and @weeks , and @year .


Outcomes assessed included detailed operative and tourniquet time , knee ROM , Knee Society scores , postoperative complications , use of antibiotics , and any subsequent surgical interventions .


These outcomes were assessed at each visit except for Knee Society scores which were collected at the @-week and @-year evaluations .


All patients completed followups up to the final evaluation at @year .


Mean wound closure time was @ minutes less using barbed sutures ( SD ,@ ; @ % CI , -@ to -@ ; p < @ ) , average @ ( SD ,@ ) versus @ ( SD ,@ ) minutes for the standard versus barbed suture types , respectively .


Overall tourniquet time was not different at @ minutes ( SD ,@ minutes ) versus @ minutes ( SD ,@ minutes ) , respectively ( p > @ ) .


There were no intraoperative clinical issues , such as provider or patient injury , using either suture .


There were no needle disengagements or suture breakages with barbed-suture closure ; five episodes of premature disengagement of the suture from the needle and three suture breakages were observed with standard closures ( p < @ ) .


There were no postoperative wound dehiscences or disruptions of the arthrotomy closure with either closure technique .


Final ROM was not different with the numbers available ( barbed-suture group mean , @ SD vs standard-suture group mean , @ SD ; p = @ , @ % CI , -@ to @ ) between patient groups at @year .


There were no differences with the numbers available in @-year Knee Society knee scores ( barbed mean , @ SD vs standard mean , @ SD ; p = @ , @ % CI , -@ to @ ) .


Considering suture material cost against time savings in operating room time , there was a cost savings of mean USD @ per case when using barbed suture .


In this randomized controlled trial , I found knotless bidirectional barbed suture to be more efficient in terms of closure time and lower in direct operative cost than conventional suture material , while showing no difference in terms of Knee Society knee scores , ROM , or wound appearance with the numbers available .


Future studies with larger numbers will be needed to compare overall costs of care and to detect uncommon complications that might arise , although none were observed in this small series .


Level I , therapeutic study .


Health care systems need effective models to manage chronic diseases like tobacco dependence across transitions in care .


Hospitalizations provide opportunities for smokers to quit , but research suggests that hospital-delivered interventions are effective only if treatment continues after discharge .


To determine whether an intervention to sustain tobacco treatment after hospital discharge increases smoking cessation rates compared with standard care .


A randomized clinical trial compared sustained care ( a postdischarge tobacco cessation intervention ) with standard care among @ hospitalized daily smokers ( mean age , @ years ; @ % were males ; @ % were non-Hispanic whites ) who wanted to quit smoking after discharge and received a tobacco dependence intervention in the hospital ; @ % of eligible patients and @ % of screened patients enrolled .


The study was conducted from August @ through November @ at Massachusetts General Hospital .


Sustained care participants received automated interactive voice response telephone calls and their choice of free smoking cessation medication ( any type approved by the US Food and Drug Administration ) for up to @ days .


The automated telephone calls promoted cessation , provided medication management , and triaged smokers for additional counseling .


Standard care participants received recommendations for postdischarge pharmacotherapy and counseling .


The primary outcome was biochemically confirmed past @-day tobacco abstinence at @-month follow-up after discharge from the hospital ; secondary outcomes included self-reported tobacco abstinence .


Smokers randomly assigned to sustained care ( n = @ ) used more counseling and more pharmacotherapy at each follow-up assessment than those assigned to standard care ( n = @ ) .


Biochemically validated @-day tobacco abstinence at @ months was higher with sustained care ( @ % ) than with standard care ( @ % ) ( relative risk -LSB- RR -RSB- , @ -LSB- @ % CI , @-@ @ -RSB- , P = @ ; number needed to treat , @ -LSB- @ % CI , @-@ @ -RSB- ) .


Using multiple imputation for missing outcomes , the RR for @-day tobacco abstinence was @ ( @ % CI , @-@ @ ; P = @ ) .


Sustained care also resulted in higher self-reported continuous abstinence rates for @ months after discharge ( @ % vs @ % for standard care ; RR , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


Among hospitalized adult smokers who wanted to quit smoking , a postdischarge intervention providing automated telephone calls and free medication resulted in higher rates of smoking cessation at @ months compared with a standard recommendation to use counseling and medication after discharge .


These findings , if replicated , suggest an approach to help achieve sustained smoking cessation after a hospital stay .


There is a high co-occurrence of cocaine and alcohol use disorders , and patients with both of these problems are difficult to treat .


There is a reasonable rationale and some empirical data to justify a pilot trial of an injectable , extended-release formulation of naltrexone for treating co-occurring cocaine and alcohol addiction .


Eighty cocaine ( n = @ ) and alcohol dependent , treatment-seeking subjects were randomly assigned to receive either two monthly extended-release injections of naltrexone or two matching placebo injections in an @-week clinical trial , with weekly medical management plus cognitive behavioral therapy visits .


No differences in reduction in cocaine or alcohol use were observed between the injectable naltrexone and placebo groups during the @-week trial .


Injectable extended-release naltrexone , while an ideal method for ensuring medication adherence in these traditionally hard-to-treat patients , did not result in any measurable reduction in cocaine or alcohol use over the course of @ weeks of treatment .


Nonalcoholic steatohepatitis ( NASH ) is associated with dyslipidemia and cardiovascular disease ( CVD ) .


To determine the relationship between resolution of NASH and dyslipidemia .


Individuals in the Pioglitazone vs. Vitamin E vs. Placebo for the Treatment of Nondiabetic Patients with Nonalcoholic Steatohepatitis ( PIVENS ) trial with paired liver biopsies and fasting lipid levels were included ( N = @ ) .


In the PIVENS trial individuals were randomised to pioglitazone @ mg , vitamin E @ IU or placebo for @ weeks .


Change in lipid levels at @ weeks was compared between those with and without NASH resolution .


Dyslipidemia at baseline was frequent , with low high-density lipoprotein ( HDL ) ( < @ mg/dL in men or < @ mg/dL in women ) in @ % , hypertriglyceridaemia ( @ mg/dL ) in @ % , hypercholesterolaemia ( @ mg/dL ) in @ % and triglycerides ( TG ) / HDL > @ in @ % .


Low-density lipoprotein ( LD ) @ mg/dL was found in @ % and elevated non-HDL cholesterol ( non-HDL-C ) ( @ mg/dL ) in @ % .


HDL increased with NASH resolution but decreased in those without resolution ( @ mg/dL vs. -@ mg/dL , P < @ ) .


NASH resolution was associated with significant decreases in TG and TG/HDL ratio compared to those without resolution ( TG : -@ vs. -@ mg/dL , P = @ and TG/HDL : -@ vs. @ , P = @ ) .


Non-HDL-C , LDL and cholesterol decreased over @ weeks in both groups , but there was no significant difference between groups .


Treatment group did not impact lipids .


NASH resolution is associated with improvements in TG and HDL but not in other cardiovascular disease risk factors including LDL and non-HDL-C levels .


Individuals with resolution of NASH may still be at increased risk of cardiovascular disease .


ClinicalTrials.gov identifier : NCT@ .


Postoperative ileus is the most common complication after ileostomy closure with an increase in morbidity , hospital stay , and health care costs .


The aim of this study is to assess the utility of a new technique for reducing postoperative ileus after protective ileostomy closure .


This is a prospective randomized study registered at ClinicalTrials.gov ( NCT@ ) .


Patients were randomly assigned to undergo either stimulation through the efferent limb of the ileostomy before surgery or nonstimulation before surgery .


This study was conducted at the Department of Surgery of the Virgen de la Arrixaca Clinical University Hospital ( Murcia ) .


Seventy patients underwent surgery for ileostomy closure .


In @ patients , during the @ weeks before surgery , daily stimulation of the defunctionalized stomal segment was performed by using a thick solution ( @ mL of physiological saline associated with @ g of thickening agent , Nestle Resource , Vevey , Switzerland ) .


In the other @ patients , stimulation was not performed before surgery .


The primary outcome was postoperative ileus .


The secondary outcomes included time to tolerating a diet and postoperative stay .


Both groups of patients were homogenous for demographic data , characteristics of the first rectal cancer operation , and intersurgery periods .


After ileostomy closure , the stimulated group of patients had an earlier return to oral tolerance ( @ vs @ days ; p = @ ) and passage of flatus or stool ( @ vs @ days ; p < @ ) than the nonstimulated group of patients .