Lay providers , working under the supervision of licensed providers , can deliver effective CBT .


The benefit of statins in patients with acute aneurysmal subarachnoid haemorrhage is unclear .


We aimed to determine whether simvastatin @ mg could improve the long-term outcome in patients with this disorder .


In this international , multicentre , randomised , double-blind trial , we enrolled patients aged @-@ years with confirmatory evidence of an aneurysmal subarachnoid haemorrhage and presenting less than @ h from ictus from @ acute neurosurgical centres in nine countries .


Patients were randomly allocated ( @:@ ) to receive either simvastatin @ mg or placebo once a day for up to @ days .


We used a computer-generated randomisation code to randomise patients in every centre by blocks of ten ( five simvastatin , five placebo ) .


Participants and investigators were masked to treatment assignment .


The primary outcome was the distribution of modified Rankin Scale ( mRS ) score obtained by questionnaire at @ months .


Analyses were done on the intention-to-treat population .


This trial has been completed and is registered with Current Controlled Trials , number ISRCTN@ .


Between Jan @ , @ , and Feb @ , @ , apart from the period between May @ , @ , and Feb @ , @ , when recruitment was on hold , @ patients were randomly assigned to receive either simvastatin @ mg ( n = @ ) or placebo ( n = @ ) .


All patients were included in the intention-to-treat population .


@ ( @ % ) patients had outcome data recorded at @ months , of whom @ ( @ % ) were classed as having a favourable outcome , mRS @-@ ( @ patients in the simvastatin group vs @ in the placebo group ) .


The primary ordinal analysis of the mRS , adjusted for age and World Federation of Neurological Surgeons grade on admission , gave a common odds ratio ( OR ) of @ , @ % CI @-@ ; p = @ .


At @ months , we recorded @ ( @ % ) deaths in the simvastatin group compared with @ ( @ % ) in the placebo group ( log-rank p = @ ) .


@ ( @ % ) serious adverse events were reported in the simvastatin group compared with @ ( @ % ) in the placebo group .


No suspected unexpected serious adverse reactions were reported .


The STASH trial did not detect any benefit in the use of simvastatin for long-term or short-term outcome in patients with aneurysmal subarachnoid haemorrhage .


Despite demonstrating no safety concerns , we conclude that patients with subarachnoid haemorrhage should not be treated routinely with simvastatin during the acute stages .


Although epidural analgesia has been used for postoperative pain control after total knee arthroplasty , its usefulness is being reevaluated because of possible adverse effects .


Recent studies have proven the efficacy of periarticular analgesic injection and its low prevalence of adverse effects .


The present study compares the clinical efficacies of epidural analgesia and periarticular injection after total knee arthroplasty .


This is a prospective , single-center , randomized controlled trial involving patients scheduled for unilateral total knee arthroplasty .


One hundred and eleven patients were randomly assigned to periarticular injection or epidural analgesia groups .


All patients were managed with spinal anesthesia .


The surgical technique and postoperative medication protocol were identical in both groups .


The primary outcome was postoperative pain at rest , quantified as the area under the curve of the scores on a visual analog pain scale to seventy-two hours postoperatively .


The Student t test and chi-square test were used to compare the data between groups .


In the intention-to-treat analysis , the periarticular injection group had a significantly lower area under the curve for pain score at rest ( @ versus @ ; p = @ ) .


In the periarticular injection group , the mean knee flexion angle was small but significantly better at postoperative day @ ( @ versus @ ; p = @ ) and postoperative day @ ( @ versus @ ; p = @ ) than in the epidural analgesia group .


The incidence of nausea at postoperative day @ was significantly lower in the periarticular injection group ( @ % versus @ % ; p < @ ) .


Transient peroneal nerve palsy was frequently seen in the periarticular injection group ( @ % versus @ % ; p = @ ) .


Compared with epidural analgesia , periarticular injection offers better postoperative pain relief , earlier recovery of knee flexion angle , and lower incidence of nausea .


Care should be taken to avoid transient peroneal nerve palsy when using periarticular injection .


Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence .


In @ the World Health Organization deemed hypertension as a global crisis as it is the leading risk factor attributed to global mortality .


Therefore , there is a great need for effective alternative treatment strategies to combat a condition that affects @ % of adults worldwide .


Recently , the FlaxPAD Trial observed a significant reduction in systolic and diastolic blood pressure in hypertensive patients with peripheral arterial disease that consumed @ g of milled flaxseed per day for one year .


However , these patients were already on anti-hypertensive medication .


Therefore , there is a need to assess if dietary flaxseed can effectively reduce blood pressure in the absence of peripheral arterial disease and anti-hypertensive medication in newly diagnosed hypertensive patients .


The HYPERFlax Trial is a parallel , superiority , phase II/III , randomized , double-blinded , controlled clinical trial .


St. Boniface Hospital and the Health Sciences Centre of Winnipeg , Canada , will recruit @ participants newly diagnosed with stage @ hypertension who have yet to be administered anti-hypertensive medication .


Participants will be randomly allocated with a @:@ ratio into a flaxseed or control group and provided food products to consume daily for six months .


At baseline , two , four , and six months , participant assessments will include the primary outcome measure , averaged automated blood pressure , and secondary measures : @-hour food recall , international physical activity questionnaire , anthropometrics , and blood and urine sampling for biochemical analysis .


Plasma will be assessed for lipids , metabolomics profiling , and molecules that regulate vascular tone .


Urine will be collected for metabolomics profiling .


With an estimated dropout rate of @ % , the trial will have a power of @ to detect differences between groups and across time , out of an effect size of @ ( SD ) at an level of @ .


This trial will determine if dietary flaxseed is efficacious over six months as an anti-hypertensive therapy in subjects newly diagnosed with hypertension .


If flaxseed can effectively reduce blood pressure as a monotherapy , then flaxseed will provide individuals on a global basis with a cost-effective food-based strategy to control hypertension .


The indocyanine green dilution method is one of the methods available to estimate plasma volume , although some researchers have questioned the accuracy of this method .


We developed a new , physiologically based mathematical model of indocyanine green kinetics that more accurately represents indocyanine green kinetics during the first few minutes postinjection than what is assumed when using the traditional mono-exponential back-extrapolation method .


The mathematical model is used to develop an optimal back-extrapolation method for estimating plasma volume based on simulated indocyanine green kinetics obtained from the physiological model .


Results from a clinical study using the indocyanine green dilution method in @ subjects with type @ diabetes indicate that the estimated plasma volumes are considerably lower when using the traditional back-extrapolation method than when using the proposed back-extrapolation method ( mean ( standard deviation ) plasma volume = @ ( @ ) mL/kg for the traditional method vs @ ( @ ) mL/kg for the proposed method ) .


The results obtained using the proposed method are more consistent with previously reported plasma volume values .


Based on the more physiological representation of indocyanine green kinetics and greater consistency with previously reported plasma volume values , the new back-extrapolation method is proposed for use when estimating plasma volume using the indocyanine green dilution method .


Breastfed infants require supplementation with vitamin D ( vD ) , but little is known about the necessary dose .


This double blind trial evaluated four different doses of vD .


Exclusively breastfed infants ( N = @ ) were randomized at @ mo to one of four doses , which they received through @ mo while receiving no formula .


The supplements provided daily @ IU , @ IU , @ IU , or @ IU of vD .


The primary endpoint was plasma @ ( OH ) D level , and secondary outcomes were plasma parathyroid hormone and calcium , and illness incidence .


The study was conducted during winter at @ N.


Most infants had low ( < @ nmol/l ) @ ( OH ) D levels at @ mo , but with supplementation levels rose .


Overall , levels of @ ( OH ) D differed significantly in proportion to vD dose .


There were no effects of vD on illness incidence or growth .


Low levels were common , with @ % of levels being < @ nmol/l and @ infants having @ to @ low levels .


The four doses of vD produced different plasma levels of @ ( OH ) D.


The higher doses were somewhat more efficacious in maintaining vD sufficiency in breastfed infants .


The findings support the recommended dose of @ IU/d , and stress the need to start supplementation at birth .


It has been suggested that the development of maternal fever during epidural analgesia could be due to intrapartum infection .


We investigated whether antibiotic prophylaxis before epidural placement decreases the rate of epidural-related fever .


In this double-blind , placebo-controlled trial , @ healthy nulliparous women requesting epidural analgesia were randomly assigned to receive either cefoxitin @ g or placebo immediately preceding initiation of epidural labor analgesia .


Maternal tympanic temperature was measured hourly , and intrapartum fever was defined as a maternal temperature of @C .


Neonates born to women with fever were evaluated for possible sepsis , and available placentas were evaluated for the presence of neutrophilic inflammation .


The primary outcome was maternal fever during epidural analgesia .


Thirty-eight percent of women in the cefoxitin group and @ % of women in the placebo group developed fever ( P = @ ) .


The risk difference ( @ % confidence interval ) for fever @C during labor ( antibiotic versus placebo ) was -@ % ( -@ to @ ) , and for fever > @C during labor was -@ % ( -@ to @ ) .


Approximately half of each study group had placental neutrophilic inflammation , but administration of cefoxitin had no significant effect on any grade of neutrophilic inflammation .


Fever developed significantly more often in the women with placental neutrophilic inflammation compared with those without such inflammation ( @/@ vs @/@ , P < @ ; risk difference @ % -LSB- @ % confidence interval , @-@ @ -RSB- ) .


There were no significant differences in any neonatal outcomes between the antibiotic and placebo study groups .


Sepsis was not diagnosed in any of the infants .


There were no neonatal deaths .


Fever during labor epidural analgesia is associated with placental inflammation , but fever and placental inflammation were not reduced with antibiotic prophylaxis .


This finding suggests that infection is unlikely to be the cause in its development .


To determine whether the use of quantitative personal exposure measurements in experimental research would result in better estimates of the associations between static and time-varying magnetic field exposure and neurocognitive test performance than when exposure categories were based solely on distance to the magnetic field source .


In our original analysis , based on distance to the magnet of a @ T MRI scanner , an effect of exposure to static magnetic fields was observed .


We performed a sensitivity analysis of test performance on a reaction task and line bisection task with different exposure measures that were derived from personal real-time measurements .


The exposure measures were highly comparable , and almost all models resulted in significant associations between exposure to time-varying magnetic fields within a static magnetic field and performance on a reaction and line bisection task .


In a controlled experimental setup , distance to the bore is a good proxy for personal exposure when placing subjects at fixed positions with standardized head movements in the magnetic stray fields of a @ T MRI .


Use of a magnetic field dosimeter is , however , important for estimating quantitative exposure response associations .


The aim of this study was to compare biweekly and monthly evolocumab with placebo and oral ezetimibe in patientswith hypercholesterolemia in a phase III trial .


Evolocumab , a fully human monoclonal antibody against proprotein convertase subtilisin/kexin type @ ( PCSK@ ) , significantly reduced LDL-C in phase II trials .


Patients @ to @ years of age with fasting low-density lipoprotein cholesterol ( LDL-C ) @ and < @ mg/dl and Framingham risk scores@ % were randomized ( @:@:@:@:@:@ ) to oral placebo and subcutaneous ( SC ) placebo biweekly ; oral placebo and SC placebo monthly ; ezetimibe and SC placebo biweekly ; ezetimibe and SC placebo monthly ; oral placebo and evolocumab @ mg biweekly ; or oral placebo and evolocumab @ mg monthly .


A total of @ patients were randomized and administered doses .


Evolocumab treatment reduced LDL-C from baseline , on average , by @ % to @ % more than placebo and @ % to @ % more than ezetimibe ( p < @ for all comparisons ) .


Evolocumab treatment also favorably altered other lipoprotein levels .


Treatment-emergent adverse events ( AEs ) , muscle-related AEs , and laboratory abnormalities were comparable across treatment groups .


In the largest monotherapy trial using a PCSK@ inhibitor to date , evolocumab yielded significant LDL-C reductions compared with placebo or ezetimibe and was well tolerated in patients with hypercholesterolemia .


( Monoclonal Antibody Against PCSK@ to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing LipidLevels-@ -LSB- MENDEL-@ -RSB- ; NCT@ ) .


The modern classroom is an inherently sedentary environment .


Virtual Field Trips ( VFTs ) using interactive whiteboards to explore virtual scenes are a potential method of converting sedentary class-time into physically active teaching .


This pilot aimed to assess the effects of a developed VFT on physical activity and learning in primary-school children .


Participants ( n = @ ) were randomly assigned to a ) a @-minute physically active London @ Olympics-themed VFT , or b ) a @-minute sedentary version of the same VFT .


Activity was measured using GT@M Actigraphs , content recall was assessed with a quiz and user evaluations were gained from teacher and pupil questionnaires .


Pupils in the active VFT displayed significantly less sedentary time ( p < @ ) , and significantly more light ( p < @ ) , moderate ( p = @ ) and vigorous physical activity ( p < @ ) than sedentary VFT pupils .


No differences in content recall were found between intervention groups : suggesting that adding physical activity into classroom teaching may not compromise attainment .


High acceptability was found in teachers and active VFT students rated their session significantly higher than sedentary pupils ( p < @ ) .


This one-day pilot provides early evidence of the ability of VFTs to convert sedentary academic time into active time .


Longitudinal research is needed to assess prolonged effects of active VFTs in reducing sedentary time .


To compare biofeedback-guided pelvic floor exercise therapy ( BFT ) with the use of oral polyethylene glycol ( PEG ) for the treatment of obstructive defecation .


A total of @ subjects were assigned to treatment with either BFT ( n = @ ) or oral PEG ( n = @ ) .


Constipation symptoms ( including difficult evacuation , hard stool , digitation necessity , incomplete emptying sensation , laxative dependence , perianal pain at defecation , and constipation satisfaction ) , Wexner Scores , and quality of life scores were assessed after @ , @ , and @ mo. .


At the @ mo follow-up , the symptoms of the BFT group patients showed significantly greater improvements compared with the PEG group regarding difficult evacuation , hard stools , digitation necessity , laxative dependence , perianal pain at defecation , constipation satisfaction , Wexner Constipation Score , and quality of life score ( P < @ ) .


The quality of life score of the BFT group at the final follow-up time ( @ mo ) was @ @ .


After a complete course of training , improvements in the clinical symptoms of the BFT group were markedly improved ( P < @ ) , and the Wexner Constipation Scores were greatly decreased compared with the oral PEG group ( P < @ ) .


We concluded that manometric biofeedback-guided pelvic floor exercise training is superior to oral polyethylene glycol therapy for obstructive defecation .


The ability to physically perform at high altitude may require unique strategies to acclimatize before exposure .


The effect of acute hypoxic exposure on the metabolic response of the skeletal muscle may provide insight into the value of short-term preacclimatization strategies .


To determine the human skeletal muscle response to a single acute bout of exercise in a hypoxic environment on metabolic gene expression .


Eleven recreationally active male participants ( @ @ years , @ @ cm , @ @ kg , @ @ % fat , @ @ L/min maximal oxygen consumption ) completed two @-hour cycling exercise trials at @ % of peak power followed by @ hours of recovery in ambient environmental conditions ( @ m ) and at normobaric hypoxic conditions simulating @ m in a randomized counterbalanced order .


Muscle biopsies were obtained from the vastus lateralis before exercise and @ hours after exercise for real-time polymerase chain reaction analysis of select metabolic genes .


Gene expression of hypoxia-inducible factor @ alpha , cytochrome c oxidase subunit @ , peroxisome proliferator-activated receptor gamma coactivator @ alpha , hexokinase , phosphofructokinase , mitochondrial fission @ , and mitofusin-@ increased with exercise ( P < @ ) but did not differ with hypoxic exposure ( P > @ ) .


Optic atrophy @ did not increase with exercise or differ between environmental conditions ( P > @ ) .


The improvements in mitochondrial function reported with intermittent hypoxic training may not be explained by a single acute hypoxic exposure , and thus it appears that a longer period of preacclimatization than a single exposure may be required .


The current phase II clinical study was conducted to evaluate the efficacy and safety of weekly docetaxel alone , and weekly docetaxel-plus-oxaliplatin , as a second-line chemotherapy in patients with cisplatin-refractory advanced gastric cancer .


We enrolled patients with histologically confirmed gastric adenocarcinoma whose disease had progressed after cisplatin-based regimens .


Patients were randomly assigned to receive docetaxel alone ( @ mg/m ( @ ) , days @ and @ ) or docetaxel ( @ mg/m ( @ ) , days @ and @ ) and oxaliplatin ( @ mg/m ( @ ) , day @ ) combination therapy every three weeks .


This trial was terminated early due to poor patient accrual rate .


From January @ to January @ , a total of @ patients were enrolled in the current study from six centers : @ patients in the docetaxel monotherapy arm and @ patients in the docetaxel/oxaliplatin combination arm .


Fifty-two patients were assessable for efficacy , and response rates as follows ( response rate : @ % in the monotherapy arm , @ % in the combination arm ; disease control rate : @ % in the monotherapy arm , @ % in the combination arm .


The median progression-free survival was @ ( @ % confidence interval = @-@ @ ) months in the monotherapy arm and @ ( @ % confidence interval = @-@ @ ) months in the combination arm ( p = @ ) .


The most common grade @ or @ adverse event was neutropenia ( @ % for monotherapy versus @ % for combination ) .


No treatment-related mortality was observed .


Weekly docetaxel and weekly docetaxel-plus-oxalipaltin regimens were found to be well-tolerated and effective as a second-line chemotherapy for patients with advanced gastric cancer .


We conducted a placebo-controlled trial of azithromycin therapy in bronchiolitis obliterans syndrome ( BOS ) post lung transplantation .


We compared azithromycin ( @mg alternate days , @weeks ) with placebo .


Primary outcome was FEV@ change at @weeks .


@ patients were randomised ; ( @ azithromycin , @ placebo ) .


It was established , post randomisation that two did not have BOS .


@ patients were analysed as intention to treat ( ITT ) with @ ` Completers ' .


ITT analysis included placebo patients treated with open-label azithromycin after study withdrawal .


The ITT analysis ( n = @ , @ observations ) estimated mean difference in FEV@ between treatments ( azithromycin minus placebo ) was @ L , with a @ % CI of -@ L to @ L ( p = @ ) .


Five withdrawals , who were identified at the end of the study as having been randomised to placebo ( four with rapid loss in FEV@ , one withdrawn consent ) had received rescue open-label azithromycin , with improvement in subsequent FEV@ at @weeks .


Study Completers showed an estimated mean difference in FEV@ between treatment groups ( azithromycin minus placebo ) of @ L , with @ % CI for the mean difference : @ L to @ L ( p = < @ ) .


Nine of @ ITT patients in the azithromycin group had @ % gain in FEV@ from baseline .


No patients in the placebo group had @ % gain in FEV@ from baseline while on placebo ( p = @ ) .


Seven serious adverse events , three azithromycin , four in the placebo group , were deemed unrelated to study medication .


Azithromycin therapy improves FEV@ in patients with BOS and appears superior to placebo .


This study strengthens evidence for clinical practice of initiating azithromycin therapy in BOS .


Patients with high Rockall scores have increased risk of ulcer rebleeding after @-day esomeprazole infusions .


To investigate whether double oral esomeprazole given after a @-day esomeprazole infusion decreases ulcer rebleeding for patients with high Rockall scores .


We prospectively enrolled @ patients with peptic ulcer bleeding who had achieved endoscopic haemostasis .


After a @-day esomeprazole infusion , patients with Rockall scores @ were randomised into the oral double-dose group ( n = @ ) or the oral standard-dose group ( n = @ ) to receive @days of oral esomeprazole @mg twice daily or once daily , respectively .


The patients with Rockall scores < @ served as controls ( n = @ ) ; they received @days of oral esomeprazole @mg once daily .


Thereafter , all patients received oral esomeprazole @mg once daily for two more weeks until the end of the @-day study period .


The primary end point was peptic ulcer rebleeding .


Among patients with Rockall scores @ , the oral double-dose group had a higher cumulative rebleeding-free proportion than the oral standard-dose group ( p = @ , log-rank test ) .


The proportion of patients free from recurrent bleeding during the @th-@th day in the oral double-dose group remained lower than that of the group with Rockall scores < @ ( p = @ , log-rank test ) .


Among patients with Rockall scores @ , the rebleeding rate was lower in the oral double-dose group than in the oral standard-dose group ( @th-@th day : @ % vs @ % , p = @ ) .


Double oral esomeprazole at @mg twice daily after esomeprazole infusion reduced recurrent peptic ulcer bleeding in high-risk patients with Rockall scores @ .


Postoperative blood loss in patients after total knee arthroplasty may cause local and systemic complications and influence clinical outcome .


The aim of this study was to assess whether fibrin glue or tranexamic acid reduced blood loss compared with routine hemostasis in patients undergoing total knee arthroplasty .


A randomized , single-center , parallel , open clinical trial was performed in adult patients undergoing primary total knee arthroplasty .


Patients were divided into four groups .


Group @ received fibrin glue manufactured by the Blood and Tissue Bank of Catalonia , Group @ received Tissucol ( fibrinogen and thrombin ) , Group @ received intravenous tranexamic acid , and Group @ ( control ) had no treatment other than routine hemostasis .


The primary outcome was total blood loss collected in drains after surgery .


Secondary outcomes were the calculated hidden blood loss , transfusion rate , preoperative and postoperative hemoglobin , number of blood units transfused , adverse events , and mortality .


One hundred and seventy-two patients were included .


The mean total blood loss ( and standard deviation ) collected in drains was @ @ mL for Group @ , @ @ mL for Group @ , @ @ mL for Group @ , and @ @ mL for Group @ .


In comparison with the control group , Group @ had significantly lower total blood loss ( p < @ ) , but it was not significantly lower in Groups @ and @ .


The overall rate of patients who had a blood transfusion was @ % ( thirty-five of @ patients analyzed per protocol ) .


Two patients required transfusion in Group @ compared with twelve patients in Group @ ( p = @ ) .


No significant difference was observed between the two fibrin glue groups and the control group with regard to the need for transfusion .


There was no difference between groups with regard to the percentage of adverse events .


Neither type of fibrin glue was more effective than routine hemostasis in reducing postoperative bleeding and transfusion requirements , and we no longer use them .


However , this trial supports findings from previous studies showing that intravenous tranexamic acid can decrease postoperative blood loss .


Type @ diabetes ( T@D ) results from destruction of pancreatic cells by autoreactive effector T cells .


We hypothesized that the immunomodulatory drug alefacept would result in targeted quantitative and qualitative changes in effector T cells and prolonged preservation of endogenous insulin secretion by the remaining cells in patients with newly diagnosed T@D .


In a multicenter , randomized , double-blind , placebo-controlled trial , we compared alefacept ( two @-week courses of @ mg/wk i.m. , separated by a @-week pause ) with placebo in patients with recent onset of T@D .


Endpoints were assessed at @ months and included meal-stimulated C-peptide AUC , insulin use , hypoglycemic events , and immunologic responses .


A total of @ patients were enrolled .


At @ months , or @ months after the last dose of alefacept , both the @-hour and the @-hour C-peptide AUCs were significantly greater in the treatment group than in the control group ( P = @ and @ , respectively ) .


Exogenous insulin requirements were lower ( P = @ ) and rates of major hypoglycemic events were about @ % reduced ( P < @ ) in the alefacept group compared with placebo at @ months .


There was no apparent between-group difference in glycemic control or adverse events .


Alefacept treatment depleted CD@ + and CD@ + central memory T cells ( Tcm ) and effector memory T cells ( Tem ) ( P < @ ) , preserved Tregs , increased the ratios of Treg to Tem and Tcm ( P < @ ) , and increased the percentage of PD-@ + CD@ + Tem and Tcm ( P < @ ) .


In patients with newly diagnosed T@D , two @-week courses of alefacept preserved C-peptide secretion , reduced insulin use and hypoglycemic events , and induced favorable immunologic profiles at @ months , well over @ year after cessation of therapy .


Millions of patients were treated with the sirolimus-eluting Cypher and the paclitaxel-eluting Taxus coronary stents with potential late-occurring increase in event rates .


Therefore , the long-term outcome follow-up is of major clinical interest .


In total , @ unselected patients with ST-segment elevation myocardial infarction ( STEMI ) , non-STEMI , stable or unstable angina pectoris were randomized to receive Cypher ( n = @ ) or Taxus ( n = @ ) stents and were followed for @ years .


The primary end-point ; the composite of cardiac death , myocardial infarction and target vessel revascularization ( major adverse cardiac event , MACE ) , occurred in @ patients ( @ % ) ; Cypher n = @ ( @ % ) , Taxus n = @ ( @ % ) , ns .


Definite and probable stent thrombosis occurred in @ patients ( @ % ) ; Cypher n = @ ( @ % ) , Taxus n = @ ( @ % ) , ns .


No statistically significant differences were found in the elements of the primary end-point or in other secondary end-points between the two stent groups .


After one year , the annual rates of stent thrombosis and MACE remained constant .


During @-year follow-up , the Cypher and the Taxus coronary stents had similar clinical outcome with no signs of increasing rates of adverse events over time .


Lysosomal acid lipase is an essential lipid-metabolizing enzyme that breaks down endocytosed lipid particles and regulates lipid metabolism .


We conducted a phase @ trial of enzyme-replacement therapy in children and adults with lysosomal acid lipase deficiency , an underappreciated cause of cirrhosis and severe dyslipidemia .


In this multicenter , randomized , double-blind , placebo-controlled study involving @ patients , we evaluated the safety and effectiveness of enzyme-replacement therapy with sebelipase alfa ( administered intravenously at a dose of @ mg per kilogram of body weight every other week ) ; the placebo-controlled phase of the study was @ weeks long and was followed by open-label treatment for all patients .


The primary end point was normalization of the alanine aminotransferase level .


Secondary end points included additional disease-related efficacy assessments , safety , and side-effect profile .


Substantial disease burden at baseline included a very high level of low-density lipoprotein cholesterol ( @ mg per deciliter ) in @ of @ patients ( @ % ) and cirrhosis in @ of @ patients ( @ % ) who underwent biopsy .


A total of @ of the @ patients who underwent randomization completed the double-blind portion of the trial and continued with open-label treatment .


At @ weeks , the alanine aminotransferase level was normal in @ of @ patients ( @ % ) in the sebelipase alfa group and in @ of @ ( @ % ) in the placebo group ( P = @ ) , with mean changes from baseline of -@ U per liter versus -@ U per liter ( P < @ ) .


With respect to prespecified key secondary efficacy end points , we observed improvements in lipid levels and reduction in hepatic fat content ( P < @ for all comparisons , except P = @ for triglycerides ) .


The number of patients with adverse events was similar in the two groups ; most events were mild and were considered by the investigator to be unrelated to treatment .


Sebelipase alfa therapy resulted in a reduction in multiple disease-related hepatic and lipid abnormalities in children and adults with lysosomal acid lipase deficiency .


( Funded by Synageva BioPharma and others ; ARISE ClinicalTrials.gov number , NCT@ . )


Cryosurgery is the most common treatment for actinic keratosis ( AK ) in the United States .


Efficacy with cryosurgery is variable , and is a modality for treating individual , visible lesions while failing to treat subclinical lesions .


FIELD Study @ ( NCT@ ) is a phase @ , multicenter , randomized , double-blind study that evaluated the short - ( @-week ) and long - ( @-month ) term efficacy and safety of sequential AK treatment using cryosurgery with liquid nitrogen followed by ingenol mebutate gel , versus cryosurgery followed by vehicle .


Overall , @ patients were randomized to ingenol mebutate @ % gel ( n = @ ) or vehicle ( n = @ ) @ weeks after cryosurgery .


Baseline characteristics were balanced across groups .


At week @ , complete clearance rate ( @ % ) in the treatment area was higher for ingenol mebutate gel compared with vehicle ( @ % vs @ % , respectively ; P = @ ) .


Mean percentage reduction in number of AKs versus baseline was also numerically higher for ingenol mebutate gel ( @ % vs @ % ) .


A general reduction from baseline lesion count was observed @ weeks after cryosurgery .


Treatment after cryosurgery was well tolerated .


Short-term ( @-week ) AK clearance rates on the face or scalp with ingenol mebutate gel after cryosurgery were higher than with cryosurgery alone .


To evaluate the contraction pattern of masticatory muscles during sustained clenching tasks with or without experimental pain induced by glutamate injection into the masseter muscle .


It was hypothesized that acute muscle pain could induce compensatory changes in the electromyographic ( EMG ) activity of the masticatory muscles .


Fifteen volunteers ( seven males , mean age SD = @ @ years ; eight females , mean age SD = @ @ years ) were recruited in a crossover experimental study .


All subjects participated in two randomized @-minute experimental sessions .


Each subject was asked to clench at @ % of the maximum voluntary contraction ( MVC ) .


After @ minutes , isotonic saline or glutamate was injected in random order into the right masseter .


EMG activity ( root mean square -LSB- RMS -RSB- and mean power frequency -LSB- MPF -RSB- ) was assessed in the masseter and anterior temporalis muscles on both sides .


Pain and fatigue were assessed by @-@ numeric rating scales ( NRS ) every minute .


Differences between conditions ( isotonic saline vs glutamate ) for all the outcome parameters were analyzed by using a mixed effect model .


The EMG activity of the masticatory muscles and pain and fatigue scores were not dependent on isotonic saline/glutamate injection ( all P > @ ) .


The RMS in the temporalis and masseter muscles increased with time ( right masseter P = @ , left masseter P = @ , right temporalis P = @ , left temporalis P = @ ) , whereas the MPF decreased ( right masseter P = @ , left masseter P < @ , right temporalis P = @ , left temporalis P = @ ) .


Scores for fatigue and pain increased during the experimental sessions ( all P < @ ) .


Intramuscular injection of glutamate caused more pain than isotonic saline but did not affect the contraction pattern of the masticatory muscles during a sustained clenching task .


This finding strongly suggests the adaptive capacity of the stomatognathic system in the presence of acute nociceptive inputs .


The purpose of this study was to investigate the hypothesis that dietary supplementation with rice bran fermented with Lentinus edodes ( rice bran exo-biopolymer , RBEP ) , a substance known to contain arabinoxylan , enhances natural killer ( NK ) cell activity and modulates cytokine production in healthy adults .


This study was designed in a randomized , double-blind , placebo-controlled , and parallel-group format .


Eighty healthy participants with white blood cell counts of @,@-@ ,@ cells/L were randomly assigned to take six capsules per day of either @ g RBEP or @ g placebo for @ weeks .


Three participants in the placebo group were excluded after initiation of the protocol ; no severe adverse effects from RBEP supplementation were reported .


NK cell activity of peripheral blood mononuclear cells was measured using nonradioactive cytotoxicity assay kits and serum cytokine concentrations included interferon ( IFN ) - , tumor necrosis factor ( TNF ) - , interleukin ( IL ) -@ , IL-@ , IL-@ , and IL-@ were measured by Bio-Plex cytokine assay kit .


This study was registered with the Clinical Research Information Service ( KCT@ ) .


Supplementation of RBEP significantly increased IFN - production compared with the placebo group ( P = @ ) .


However , RBEP supplementation did not affect either NK cell activity or cytokine levels , including IL-@ , IL-@ , IL-@ , IL-@ , and TNF - , compared with the placebo group .


The data obtained in this study indicate that RBEP supplementation increases IFN - secretion without causing significant adverse effects , and thus may be beneficial to healthy individuals .


This new rice bran-derived product may therefore be potentially useful to include in the formulation of solid and liquid foods designed for treatment and prevention of pathological states associated with defective immune responses .


Inflammation contributes to the pathogenesis of psoriasis as well as atrial fibrillation .


The impact of psoriasis and its association with new-onset atrial fibrillation was assessed in hypertensive patients with left ventricular hypertrophy ( LVH ) .


The predictive value of baseline or incident psoriasis for new-onset atrial fibrillation was evaluated in @ hypertensive patients with electrocardiographic LVH with no history of atrial fibrillation or other cardiovascular disease , in sinus rhythm on their baseline electrocardiogram .


A total of @ patients ( @ % ) had or developed psoriasis and new-onset atrial fibrillation occurred in @ patients ( @ % ) during a mean follow-up of @ @ years .


At baseline , the psoriasis patients were younger ( @ @ vs. @ @ years ) and had less left ventricle hypertrophy by ECG Sokolow-Lyon voltage ( @ @ vs. @ @ mm ) ; higher hemoglobin ( @ @ vs. @ @ mmol/l ) and prevalence of diabetes ( @ vs. @ % , P @ ) than patients without psoriasis .


In multivariable Cox analysis , adjusting for age , sex , hemoglobin , diabetes , time-varying SBP , heart rate , study treatment and Sokolow-Lyon hypertrophy , psoriasis , treated as a time-varying covariate , was associated with a two-fold higher risk of new-onset atrial fibrillation -LSB- hazard ratio : @ ( @ % confidence interval ( CI ) : @-@ @ ) , P = @ -RSB- .


Propensity-matched analysis yielded similar results ( odds ratio : @ , @ % CI @-@ @ , P = @ ) .


Psoriasis has a similar prevalence in hypertensive patients as in the general population .


Psoriasis independently predicted new-onset atrial fibrillation despite lower age and electrocardiographic LVH in psoriasis patients than in patients without psoriasis .


Many patients with relapsing-remitting multiple sclerosis ( MS ) treated with high-dose interferon - ( IFN ) develop serum binding antibodies ( BAb ) and neutralizing antibodies ( NAb ) .


NAb reduces the biological activity of IFN , which contributes to clinical failure in these patients .


We investigated whether access to antibody ( Ab ) test results would alter usual care of ( IFN ) - treated patients and whether BAb could predict NAb .


This was a randomized , controlled , open-label , parallel-group , multicenter study in patients with multiple sclerosis .


Subjects ( n = @ ) were randomly assigned to Ab testing or usual care .


BAb and NAb titres were measured using standard assays .


Primary and secondary outcomes were the proportion of patients whose IFN therapy changed and the type of and reasons for therapy changes .


Therapy changes differed between the Ab testing and usual care arms ( @ % and @ % , respectively ; p = @ ) .


Results from Ab testing were more frequently reported as the reason for therapy change in the Ab testing arm than in the usual care arm ( p < @ ) .


NAb and BAb positivity significantly increased the likelihood of therapy change and reduced IFN-associated adverse events .


BAb titres were a significant predictor of NAb positivity ( p = @ ) .


Initial BAb-positive and NAb-positive status in both study arms had a significant impact on the overall number of patients with a therapy change ( p < @ ) .


Access to Ab test results impacted therapy management .


BAb titres can predict NAb positivity in patients on high-dose IFN .


The aim of this report was to clinically and radiographically evaluate changes to the hard and soft tissues around implants placed in extraction sockets grafted with medical grade calcium sulfate hemihydrate ( MGCSH ) mixed with platelet-rich plasma ( PRP ) and a collagen resorbable plug after one year of function .


This evaluation was part of a previous study conducted to evaluate extraction socket grafts .


Fourteen subjects out of @ were evaluated .


After tooth extraction , eight subjects received MGCSH mixed with PRP in the extraction sockets ( test group ) , and six subjects received collagen resorbable plug dressing material ( control group ) .


After three months of bone healing , dental implants were placed .


Three months after implant installation , provisional restorations were placed and implants were loaded in function for one month followed by definitive restorations .


Follow-up examinations and intraoral digital radiographs were made at baseline and one year after definitive restorations to evaluate the marginal bone level in each subject .


At the one-year follow-up , the survival and success rate was @ % for all implants .


There was no statistically significant difference in the amount of vertical bone loss between groups after @ year ( p > @ ) .


For the test group , there was a mean mesial bone loss of -@ + / - @ mm and a mean distal bone loss of -@ + / - @ mm .


For the control group , there was a mean mesial bone loss of -@ + / - @ mm and a mean distal bone loss of -@ + / - @ mm .


At the one-year follow-up , the implant placement in grafted sockets was not affected by the type of the graft material .


Implants placed in sockets grafted with MGCSH mixed with PRP showed less marginal bone loss after one year in comparison to those with collagen resorbable grafts .


Patients with HIV on antiretroviral therapy might benefit from regimen simplification to reduce pill burden and dosing frequency .


We aimed to assess the safety and efficacy of simplifying the treatment regimen for adults with virologically suppressed HIV infection from a ritonavir-boosted protease inhibitor and emtricitabine plus tenofovir disoproxil fumarate ( tenofovir ) regimen to coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir .


STRATEGY-PI is a @ week , international , multicentre , randomised , open-label , phase @b trial in which HIV-infected adults with a plasma HIV-@ RNA viral load of less than @ copies per mL for at least @ months who were taking a ritonavir-boosted protease inhibitor with emtricitabine plus tenofovir were randomly assigned ( @:@ ) either to switch to coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir or to continue on their existing regimen .


Key eligibility criteria included no history of virological failure , no resistance to emtricitabine and tenofovir , and creatinine clearance of @ mL/min or higher .


Neither participants nor investigators were masked to group allocation .


The primary endpoint was the proportion of participants with a viral load of less than @ copies per mL at week @ , based on a US Food and Drug Administration snapshot algorithm for the modified intention-to-treat population , which excluded major protocol violations ( prohibited resistance or not receiving a protease inhibitor at baseline ) .


We prespecified non-inferiority with a @ % margin ; if non-inferiority was established , superiority was tested as per a prespecified sequential testing procedure .


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


Between Dec @ , @ , and Dec @ , @ , @ participants were randomly assigned and received at least one dose of study drug .


Of these participants , @ were assigned to switch to the simplified regimen ( switch group ) and @ to remain on their existing regimen ( no-switch group ) ; after exclusions , @ and @ participants , respectively , were analysed in the modified intention-to-treat population .


At week @ , @ ( @ % ) of @ participants in the switch group maintained a viral load of less than @ copies per mL , compared with @ ( @ % ) of @ in the no-switch group ( difference @ % , @ % CI @-@ ; p = @ ) .


The statistical superiority of the simplified regimen was mainly caused by a higher proportion of participants in the no-switch group than in the switch group discontinuing treatment for non-virological reasons ; virological failure was rare in both groups ( two -LSB- @ % -RSB- of @ vs two -LSB- @ % -RSB- of @ ) .


We did not detect any treatment-emergent resistance in either group .


Adverse events leading to discontinuation were rare in both groups ( six -LSB- @ % -RSB- of @ vs four -LSB- @ % -RSB- of @ ) .


Switching to the simplified regimen was associated with a small , non-progressive increase from baseline in serum creatinine concentration .


Nausea was more common in the switch group than in the no-switch group , but rates of diarrhoea and bloating decreased compared with baseline from week @ to week @ in the switch group , whereas there were generally no changes for these symptoms in the no-switch group .


Coformulated elvitegravir , cobicistat , emtricitabine , and tenofovir might be a useful regimen simplification option for virologically supressed adults with HIV taking a multitablet ritonavir-boosted protease inhibitor regimen .


The aim of this study is to assess the efficacy of an initial dose of ribavirin administered before a @-week course of treatment with peg-IFN + ribavirin in treatment-nave patients and in patients after previous failure of CHC treatment .


A total of @ patients with chronic hepatitis C infected with genotype @ HCV were qualified to the study .


Study patients were randomised to receive one of two treatments : A - RBV for @ weeks followed by combined therapy with peg-IFN alpha-@a + RBV for @ weeks ( n = @ ) , or B - combined therapy with peg-IFN alpha-@a + RBV for @ weeks ( n = @ ) .


SVR @ was observed in @ % patients in group A and in group @ % patients in group B ( @ % ) , p > @ .


Comparing subgroups of the naive patients , it was found that the SVR@ value was higher in group A than group B ( @ % vs. @ % , p > @ ) .


In the re-therapy subgroups , higher treatment response rates in patients not responding earlier was found in group A than group B ( @ % vs. @ % , p > @ ) .


No significant advantage was found in the use of a priming method over a standard regimen .


However , it could be recommended in patients with a total lack of response to peg-IFN and ribavirin when no other therapeutic options are available .


Vitamin D deficiency affects @ billion people globally .


It has an important role in bone homeostasis , brain development and modulation of the immune system and yet the impact of antenatal vitamin D deficiency on infant outcomes is poorly understood .


We assessed the association of @ - hydroxyvitamin D levels ( @-OHD ) in late pregnancy and early infant growth and developmental outcomes in rural Vietnam .


A prospective cohort study of @ women who had previously participated in a double-blind cluster randomized controlled trial of antenatal micronutrient supplementation in rural Vietnam was undertaken .


Maternal @-OHD concentration was measured at @ weeks gestation , and infants were followed until @ months of age .


Main outcome measures were cognitive , motor , socio-emotional and language scores using the Bayley Scales of Infant Development , @rd edition , and infant length-for-age z scores at @ months of age .


@ % ( @/@ ) of women had @-OHD levels < @ nmol/L at @ weeks gestation .


Infants born to women with @-OHD deficiency ( < @ nmol/L ) had reduced developmental language scores compared to those born to women who were vitamin D replete ( @ nmol/L ) ( Mean Difference ( MD ) -@ , @ % Confidence Interval ( CI ) -@ to -@ ) .


For every @ nmol increase in @-OHD concentration in late pregnancy , infant length-for-age z scores at @ months of age decreased by @ ( @ % CI -@ to -@ ) .


Low maternal @ - hydroxyvitamin D levels during late pregnancy are of concern in rural Vietnam , and are associated with reduced language developmental outcomes at @ months of age .


Our findings strengthen the evidence for giving vitamin D supplementation during pregnancy .


Poor management of chronic medical treatments may result in severe health consequences for patients as well as costs for society .


Non-adherence is common among patients with type @ diabetes .


Interventions by community pharmacists may assist in improving adherence and consequently health outcomes for patients with type @ diabetes .


The study aimed to investigate whether a comprehensive and a brief individually targeted intervention for patients with type @ diabetes could improve implementation of drug therapy in Danish community pharmacies .


The interventions intended to give patients more competence and support to improve adherence and self-management in order to reach treatment goals for diabetes and blood pressure as well as goals for patient perceived outcomes .


This study was an RCT , comparing two interventions ; basic intervention ( BI ) and extended intervention ( EI ) .


The intervention model sought to identify drug-related problems as well as issues experienced by patients in relation to medicines use , and consequently find individually tailored solutions to address the identified problems .


The trial included five pharmacies ; five pharmacists and five pharmaconomists , and @ patients ; BI ( @ patients ) , EI ( @ patients ) , Control ( @ patients ) .


Patient reported systolic blood pressure improved in both groups and significantly in the EI group compared to the control group ( P = @ ) .


Increase in disease-related knowledge was higher in the EI group compared to the control group ( P = @ ) , but not in the BI group ( P = @ ) .


Except for quality of life , the EI group reported significantly higher improvement in all aspects of beneficial effects from participating in the trial when compared to the control group .


No significant differences were detected for changes in hospital admissions or in doctor visits .


The two intervention groups reported significantly higher satisfaction with all aspects of patient satisfaction with pharmacy staff in the project than control patients .


The study showed improvement in patient health , well-being , knowledge , and satisfaction as a result of the trial , particularly for the EI group .


Thus a program comprising patient narratives , problem and resource identification , and multi-dimensional individually tailored patient medication management solutions seems to be an appropriate intervention to ensure outcome improvement of non-adherent patients .


The @-stage approach ( @-SA ) is used as a didactic method for teaching practical skills in international courses on resuscitation and the structured care of trauma patients .


The aim of this study was to evaluate objective and subjective learning success of a video-assisted @-SA in teaching undergraduate medical students .


The participants were medical students learning the principles of the acute treatment of trauma patients in their multidiscipline course on emergency and intensive care medicine .


The participants were quasi - randomly divided into two groups .


The @-SA was used in both groups .


In the control group , all four steps were presented by an instructor .


In the study group , the first two steps were presented as a video .


At the end of the course a @-minute objective , structured clinical examination ( OSCE ) of a simulated trauma patient was conducted .


The test results were divided into objective results obtained through a checklist with @ dichotomous items and the assessment of the global performance rated subjectively by the examiner on a Likert scale from @ to @ .


@ students were recruited ; the results of @ were suitable for analysis .


The OSCE results were excellent in both groups and did not differ significantly ( control group : median @ , interquantil range ( IQR ) @-@ , study group : median @ , IQR @-@ ; p = @ ) .


The global performance was rated significantly better for the study group ( median @ , IQR @-@ vs. median @ , IQR @-@ ; p < @ ) .


The relative knowledge increase , stated by the students in their evaluation after the course , was greater in the study group ( @ % vs. @ % ) .


It is possible to employ video assistance in the classical @-SA with comparable objective test results in an OSCE .


The global performance was significantly improved with use of video assistance .


Although anti-vascular endothelial growth factor treatment of neovascular age-related macular degeneration ( AMD ) results in improved vision overall , loss of substantial vision can occur .


Understanding the processes that lead to loss of vision may lead to preventive strategies .


To determine the incidence , characteristics , causes , and baseline predictors of sustained visual acuity loss after @ years of treatment with ranibizumab or bevacizumab for neovascular AMD .


A cohort study within a randomized clinical trial of participants in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) .


Participants were randomly assigned to treatment with ranibizumab or bevacizumab and to @ years of monthly or as needed injections or monthly injections for @ year and as needed injections the following year .


Sustained visual acuity loss , defined as loss of @ or more letters from baseline at weeks @ and @ .


Among @ participants , @ eyes ( @ % ) developed sustained visual acuity loss in @ years .


Within this group , visual acuity decreased gradually over time , with a mean decrease of @ , @ , and @ letters from baseline at @ weeks , @ year , and @ years , respectively .


At @ years , eyes with sustained visual acuity loss had more scarring ( @ % vs @ % , P = @ ) , more geographic atrophy ( GA ) ( @ % vs @ % , P = @ ) , larger lesions ( @ vs @ mm@ , P < @ ) , and higher proportions of intraretinal fluid ( @ % vs @ % , P < @ ) , subretinal hyperreflective material ( @ % vs @ % , P < @ ) , retinal thinning ( @ % vs @ % , P < @ ) , and thickening ( @ % vs @ % , P < @ ) .


Likely causes of sustained visual acuity loss included foveal scarring ( @ % ) , pigmentary abnormalities ( @ % ) , and foveal GA ( @ % ) .


Baseline factors independently associated with a higher incidence of sustained visual acuity loss were the presence of nonfoveal GA ( odds ratio -LSB- OR -RSB- , @ ; @ % CI , @-@ @ ; P = @ ) , larger area of choroidal neovascularization ( OR for a > @-disc area vs @-disc area , @ ; @ % CI , @-@ @ ; P = @ ) , and bevacizumab treatment ( OR , @ ; @ % CI , @-@ @ ; P = @ ) .


Sustained visual acuity loss was relatively rare in CATT .


The development of foveal scar , pigmentary abnormalities , or GA contributed to most of the sustained visual acuity loss .


Risk was @ % higher among eyes treated with bevacizumab .


Treatment that targeted the prevention of scarring or GA may improve vision outcomes .


To compare @ digital flexible ureteroscopes in a randomized , prospective , clinical trial ; the complementary metal oxide semiconductor-based Gyrus ACMI/Olympus Invisio DUR-D and the charged coupled device-based Olympus URF-V .


Patients scheduled for ureteroscopy were prospectively enrolled and randomized between the DUR-D and URF-V .


Patient demographics , laser and total procedure time , laser energy , lower pole time , and difficulties encountered were recorded .


The visibility and maneuverability were rated on a scale of @-@ .


A total of @ patients ( @ women ) with a mean age of @ years ( @-@ years ) were enrolled .


Laser lithotripsy ( mean stone size , @ mm ) was performed in @ patients , @ underwent stone basketing , and @ had diagnostic ureteroscopy .


For the DUR-D and URF-V , the mean total operative time ( @ vs @ minutes ) , laser time ( @ vs @ minutes ) , lower pole time ( @ vs @ minutes ) , and basket time ( @ vs @ minutes ) were comparable .


In @ of @ ( @ % ) and @ of @ ( @ % ) cases , the stone could not be reached with the DUR-D and URF-V , respectively .


A fiberoptic scope ( URF-P@ ) reached the stone in all cases .


On a scale of @-@ , the mean visibility was @ and @ ( P < @ ) and the maneuverability was @ and @ ( P < @ ) for DUR-D and URF-V , respectively .


There were @ repairs , @ for each scope .


The DUR-D averaged @ cases per repair and the URF-V averaged @ .


The URF-V offered better visibility and maneuverability compared with the DUR-D .


Both had similar failure rates compared with the previous study with fiberoptic scopes .


Ability to perform basic daily activity represented by functional status ( FNS ) before surgery can be assessed in the clinic for determining health status of the patient .


We sought to study the effect of FNS on postoperative outcomes after carotid endarterectomy ( CEA ) in a national data set .


National Surgical Quality Improvement Project is a national data set , which includes data from > @ hospitals .


Patients who underwent CEA were identified by Current Procedural Terminology code and divided into @ categories based on FNS : independent , partially dependent , and dependent .


Thirty-day postoperative stroke , death , and other postoperative complications were identified as the study end point .


We used multivariate logistic regression to estimate odds ratio for outcomes while controlling for sex , race , diabetes mellitus , cardiovascular disease , smoking , and other confounders .


Of @ @ CEAs , @ @ ( @ % ) were functionally independent , @ ( @ % ) were functionally partially dependent , and @ ( @ % ) were functionallydependent .


In functionally independent group , there were @ ( @ % ) strokes , @ ( @ % ) deaths , and @ ( @ % ) other complications , whereas in the functionally partially dependent group , there were @ ( @ % ) strokes , @ ( @ % ) deaths , and @ ( @ % ) other complications .


In multivariable risk-adjusted model , using functionally independent as reference , functionally partially dependent was associated with death ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) , stroke ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) , and other complications ( odds ratio , @ ; @ % confidence interval , @-@ @ ; P < @ ) .


In this national data set , patient 's inability to perform basic activities of independent living is associated with adverse postoperative outcomes after CEA .


Hence , FNS should be vigilantly assessed in clinic for risk stratification along with other objective factors for gauging risk of adverse outcomes after CEA .


Excessive weight gain during pregnancy is a risk factor for postpartum weight retention and future weight gain and obesity .


Whether a behavioral intervention in pregnancy can reduce long-term weight retention is unknown .


This randomized trial tested whether a low-intensity behavioral intervention to prevent excessive gestational weight gain could increase the proportion of women who returned to prepregnancy weight by @ mo postpartum .


Women ( n = @ , @ wk of gestation , @ % normal weight , @ % overweight/obese ) were randomly assigned into an intervention or control group ; @ % completed the @-mo assessment .


The telephone-based intervention targeted gestational weight gain , healthy eating , and exercise and was discontinued at delivery .


In modified intent-to-treat analyses that excluded women with miscarriages ( n = @ ) , gestational diabetes ( n = @ ) , or subsequent pregnancies ( n = @ ) , the intervention had no significant effect on the odds of achieving prepregnancy weight at @ mo postpartum ( n = @ ; @ % compared with @ % ; P = @ ) .


Completer analyses suggested that the intervention tended to increase the percentages of women who reached prepregnancy weight ( n = @ ; @ % compared with @ % ; P = @ ) and significantly reduced the magnitude of mean SD postpartum weight retained ( @ @ compared with @ @ kg ; P = @ ) at @ mo. .


Women in the intervention group reported higher dietary restraint through @ mo postpartum ( P = @ ) and more frequent self-monitoring of body weight ( P < @ for all ) throughout the study .


A low-intensity behavioral intervention in pregnancy can reduce @-mo postpartum weight retention and improve dietary restraint and self-weighing in study completers .


Future research is needed to test the long-term effects of more intensive behavioral interventions in pregnancy .


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


To determine basal and stimulated C-peptide percentiles in North American children and adolescents at risk for type @ diabetes ( T@D ) and to examine factors associated with this distribution in the Diabetes Prevention Trial-Type @ ( DPT-@ ) .


We included @ subjects aged @-@ years at randomization in the DPT-@ trials .


A @-h oral glucose tolerance test ( OGTT ) was performed at baseline and every @ months during the @-year follow-up period .


The percentile values of C-peptide after baseline OGTT were estimated according to age , BMI Z score ( BMIZ ) , and/or sex categories .


Conditional quantile regression was used to examine the relationship between C-peptide percentiles and various independent variables .


The basal and stimulated C-peptide levels increased significantly as age and BMIZ increased ( P < @ ) .


Both age and BMIZ had a stronger impact on the upper quartile of C-peptide distributions than the lower quartile .


Sex was only significantly associated with stimulated C-peptide .


Higher stimulated C-peptide levels were generally observed in girls compared with boys at the same age and BMIZ ( P < @ ) .


HLA type and number of positive antibodies and antibody titers ( islet cell antibody -LSB- ICA -RSB- , insulin autoantibody , GAD@A , and ICA@A ) were not significantly associated with C-peptide distribution after adjustment for age , BMIZ , and sex .


Age - , sex - , and BMIZ-specific C-peptide percentiles can be estimated for North American children and adolescents at risk for T@D .


They can be used as an assessment tool that could impact the recommendations in T@D prevention trials .


To investigate the effects of repeated botulinum toxin A ( BoNT-A ) injections combined with occupational therapy , including a splint , compared with occupational therapy alone on hand function in children with unilateral spastic cerebral palsy ( USCP ) , in all International Classification of Functioning , Disability and Health ( ICF ) domains .


This was a randomized controlled study , population-based and evaluator-blinded for primary outcome ( October @ to September @ ) .


Twenty children ( @ males ; median age @y @mo ) with USCP , recruited at a rehabilitation centre in Sweden , were assigned to one of two parallel groups using concealed allocation .


In the course of one year , @ children received occupational therapy , while @ received repeated BoNT-A plus occupational therapy ( BoNT-A/OT ) .


Primary outcome ( Assisting Hand Assessment -LSB- AHA -RSB- ) , and secondary outcome measures ( range of movement -LSB- ROM -RSB- , and Canadian Occupational Performance Measure ) , were measured at baseline , @ , @ , @ , and @months .


AHA revealed a superior effect in the BoNT-A/OT group at @months : @ out of @ improved compared with @ out of @ in the occupational therapy group ( p < @ ) .


A @ % Peskun exact confidence interval for the difference in proportions is given as @ to @ .


Secondary outcomes improved in both groups .


Repeated BoNT-A/OT appeared superior to occupational therapy alone for bimanual performance in young children with USCP .


Active ROM and goal performance improved in both groups .


It is unclear whether patients with early-stage Hodgkin 's lymphoma and negative findings on positron-emission tomography ( PET ) after three cycles of chemotherapy with doxorubicin , bleomycin , vinblastine , and dacarbazine ( ABVD ) require radiotherapy .


Patients with newly diagnosed stage IA or stage IIA Hodgkin 's lymphoma received three cycles of ABVD and then underwent PET scanning .


Patients with negative PET findings were randomly assigned to receive involved-field radiotherapy or no further treatment ; patients with positive PET findings received a fourth cycle of ABVD and radiotherapy .


This trial assessing the noninferiority of no further treatment was designed to exclude a difference in the @-year progression-free survival rate of @ or more percentage points from the assumed @ % progression-free survival rate in the radiotherapy group .


A total of @ patients ( @ % male ; median age , @ years ) were recruited , and @ patients underwent PET scanning .


The PET findings were negative in @ of these patients ( @ % ) , @ of whom were randomly assigned to a study group ( @ to the radiotherapy group and @ to no further therapy ) .


At a median of @ months of follow-up , there had been @ instances of disease progression in the radiotherapy group , and @ patients had died ( @ with disease progression , @ of whom died from Hodgkin 's lymphoma ) ; there had been @ instances of disease progression in the group with no further therapy , and @ patients had died ( @ with disease progression and none from Hodgkin 's lymphoma ) .


In the radiotherapy group , @ of the deaths occurred in patients who received no radiotherapy .


The @-year progression-free survival rate was @ % ( @ % confidence interval -LSB- CI -RSB- , @ to @ ) in the radiotherapy group and @ % ( @ % CI , @ to @ ) in the group that received no further therapy , with an absolute risk difference of -@ percentage points ( @ % CI , -@ to @ ) .


The results of this study did not show the noninferiority of the strategy of no further treatment after chemotherapy with regard to progression-free survival .


Nevertheless , patients in this study with early-stage Hodgkin 's lymphoma and negative PET findings after three cycles of ABVD had a very good prognosis either with or without consolidation radiotherapy .


( Funded by Leukaemia and Lymphoma Research and others ; RAPID ClinicalTrials.gov number , NCT@ . )


As stereotactic radiotherapy ( SRT ) becomes widespread , precise information including number , location , and margin of lesions is required when magnetic resonance ( MR ) imaging of brain metastasis is performed .


We compare methods using @ separate injections and a single injection for the administration of a double dose of contrast medium for contrastenhanced MR imaging .


We divided @ patients with brain metastasis into @ groups of @ patients .


Group A received @ separate injections ( @ + @ mL/kg ) of contrast medium ( gadoteridol ) ; Group B received a single injection of the same total dose ( @ mL/kg ) .


Group A underwent spin echo ( SE ) T@-weighted imaging ( T@WI ) and magnetization prepared rapid acquisition with gradient echo sequence ( MPRAGE ) after each injection , and Group B underwent the same MR studies at the same timing as Group A.


We evaluated the number , signal-to-noise ratio ( SNR ) , diameter , margin delineation , and volume of lesions and compared them between early and delayed studies by the @ methods .


The number of detected lesions was largest in delayed studies of MPRAGE in both groups .


The SNR of the lesions was statistically lower in early studies of Group A than other studies .


Delayed studies of Group B showed statistically better margin delineation than other studies on both SE-T@WI and MPRAGE studies .


Diameter and enhanced volume were statistically significantly larger on delayed phase than early phase in both groups .


Use of a single injection of double-dose contrast medium and longer delay time may improve margin delineation of lesions for the study of brain metastasis .


Enhanced volume was larger on delayed phase , and it may influence selection of therapeutic strategy .


Patients with sciatica frequently complain about associated back pain .


It is not known whether there are prognostic relevant differences in Magnetic Resonance Imaging ( MRI ) findings between sciatica patients with and without disabling back pain .


The study population contained patients with sciatica who underwent a baseline MRI to assess eligibility for a randomized trial designed to compare the efficacy of early surgery with prolonged conservative care for sciatica .


Two neuroradiologists and one neurosurgeon independently evaluated all MR images .


The MRI readers were blinded to symptom status .


The MRI findings were compared between sciatica patients with and without disabling back pain .


The presence of disabling back pain at baseline was correlated with perceived recovery at one year .


Of @ included sciatica patients , @ ( @ % ) had disabling back pain .


Of the patients with both sciatica and disabling back pain @ % did reveal a herniated disc with nerve root compression on MRI , compared to @ % of patients with predominantly sciatica ( P < @ ) .


The existence of disabling back pain in sciatica at baseline was negatively associated with perceived recovery at one year ( Odds ratio -LSB- OR -RSB- @ , @ % Confidence Interval @-@ @ , P < @ ) .


Sciatica patients with disabling back pain in absence of nerve root compression on MRI at baseline reported less perceived recovery at one year compared to those with predominantly sciatica and nerve root compression on MRI ( @ % vs @ % , P < @ ) .


Sciatica patients with disabling low back pain reported an unfavorable outcome at one-year follow-up compared to those with predominantly sciatica .


If additionally a clear herniated disc with nerve root compression on MRI was absent , the results were even worse .


Vitamin D deficiency is associated with cardiovascular ( CV ) risk in multiple populations , including those with chronic kidney disease ( CKD ) .


The active form of the hormone ( @,@ OH@D@ ) binds to receptors in multiple organs .


CKD patients are deficient in both @ Vitamin D and @,@ OH@D@ .


Clinical trial data demonstrating the benefits of vitamin D formulations are limited , and fail to show significant benefits on CV outcomes , and have compared different compounds , in various populations , and focused on a variety of outcomes .


A understanding of the mechanism by which different vitamin D compounds confer CV protection in CKD is important for the design of future studies .


This @ arm randomized prospective double-blinded placebo-controlled study examining the impact of calcitriol ( @,@ OH@D@ ) and @-hydroxyvitamin D@ supplementation compared to placebo on vascular stiffness , as measured by pulse wave velocity ( PWV ) .


Patients are enrolled from @ tertiary care institutions if they meet inclusion criteria ( stable estimated glomerular filtration rate ( eGFR ) between @-@ml / min , < @ml/min change in previous @ months ) , on stable doses of renin-angiotensin aldosterone system blockade .


For those already receiving vitamin D therapies , a @ month washout period before randomization is mandatory .


Treatment duration is @ months ; medications are given thrice weekly in fixed doses .


The primary outcome measure is Vascular stiffness , measured non-invasively by pulse wave velocity ( PWV ) .


Other measurements include BP , kidney function and serial blood levels of biomarkers .


The primary analysis will compare any vitamin D therapy versus placebo for the primary outcome defined as the change of PWV from baseline to @ months .


Analysis of covariance will be used to detect differences between vitamin D preparations in the magnitude of reduction in PWV .


This study is novel in that we are using a robust study design in CKD patients ( not on dialysis ) comparing placebo to different forms of vitamin D supplementation in fixed doses , irrespective of baseline values .


We hope to demonstrate the biological mechanistic effect of vitamin D supplementation on vascular function in order for this information to be used in designing larger randomized controlled trials .


Previous small-molecule antiangiogenics have compromised chemotherapy dose intensity in breast cancer .


We present a phase I trial of a novel selective agent , nintedanib , plus standard chemotherapy in early breast cancer .


Her-@-negative breast cancer patients with tumours larger than @cm were eligible for dose-escalation trial ( classic @ +@ method ) .


The recommended phase II dose ( RP@D ) was @mg BID of nintedanib combined with standard dose of weekly paclitaxel followed by adriamycin plus cyclophosphamide .


The dose-limiting toxicity was transaminase elevation .


At the RP@D , the dose intensity was @ % .


The pathologic complete response was @ % .


The combination allows the delivery of full-dose intensity , while efficacy seems promising .


There is uncertainty whether cancer screening affects participant incentives for favourable lifestyle .


The present study investigates long-term effects of colorectal cancer ( CRC ) screening on lifestyle changes .


In @-@ , men and women drawn from the population registry were randomised to screening for CRC by flexible sigmoidoscopy ( ` invited-to-screening ' arm ) or to no-screening ( control arm ) in the Norwegian Colorectal Cancer Prevention trial .


A subgroup of @ individuals in the ` invited-to-screening ' and @ in the control arm , aged @-@years , randomised during @ had their lifestyle assessed by a questionnaire at inclusion and after @years ( @ % of cohort ) .


The outcome was @-year changes in lifestyle factors ( body weight , smoking status , physical exercise , selected dietary habits ) and in total lifestyle score ( @-@ points , translating to the number of lifestyle recommendations adhered to ) .


We compared outcomes in the two randomisation arms and attendees with positive versus negative findings .


Total lifestyle scores improved in both arms .


The improvement was smaller in the ` invited-to-screening ' arm ( score @ at inclusion ; @ after @years ) compared with the control arm ( score @ at inclusion ; @ after @years ) ; adjusted difference -@ ( @ % CI -@ to -@ ; p = @ ) .


The change in the score was less favourable in screening attendees with a positive compared with negative screening result ; adjusted difference -@ ( @ % CI -@ to -@ ; p < @ ) .


The present study suggests that possible unfavourable lifestyle changes after CRC screening are modest .


Lifestyle counselling may be considered as part of cancer screening programmes .


Medication-overuse headache ( MOH ) is common in the general population , and most patients are managed in primary health care .


Brief Intervention ( BI ) has been used as a motivational technique for patients with drug and alcohol overuse , and may a have role in the treatment of MOH .


To explore GPs ' experiences using BI in the management of patients with MOH .


Qualitative study in Norwegian general practice .


Data were collected through four focus group interviews with @ GPs who participated in an intervention study on BI for MOH .


Systematic text condensation was used to analyse transcripts from the focus group interviews .


The GPs experienced challenges when trying to convince patients that the medication they used to treat and prevent headache could cause headache , but labelling MOH as a diagnosis opened up a space for change .


GPs were able to use BI within the scope of a regular consultation , and they thought that the structured approach had a potential to change patients ' views about their condition and medication use .


Being diagnosed with medication overuse could bring about feelings of guilt in patients , and GPs emphasised that a good alliance with the patient was necessary for successful change using BI to manage MOH .


GPs experience BI as a feasible strategy to treat MOH , and the technique relies on a good alliance between the doctor and patient .


When using BI , GPs must be prepared to counter patients ' misconceptions about medication used for headache .


Preoperative Anxiety is a negative factor in anesthetic and surgical experience .


Among the strategies for reducing children 's anxiety , non-pharmacological strategies are as important as the pharmacological ones , but its validity is still controversial .


The aim of this study was to verify if the information provided to guardians interferes with child anxiety .


@ children , @-@ years old , ASA I and II , undergoing elective surgical procedures and their guardians were randomly divided into two groups : control group ( CG ) = guardian received conventional information about anesthesia ; informative group ( IG ) = guardian received an information leaflet about anesthesia .


Children 's anxiety was assessed using the modified Yale Preoperative Anxiety Scale ( m-YPAS ) on two occasions : at the surgical theater waiting room ( WR ) and at the operating room ( OR ) .


Parents ' anxiety was assessed using the Hamilton Anxiety Scale ( HAM-A ) at the CT. .


There was no difference in demographic data between groups .


The level of anxiety in children showed no difference between groups at two measured times .


There was statistically significant difference in anxiety levels between WR and OR in both groups , p = @ for CG and p < @ for GI , as well as the prevalence of anxiety for CG ( @ % WR and @ % OR , p = @ ) and GI ( @ % WR and @ % OR , p < @ ) .


The anxiety level of guardians did not differ between groups .


Regardless of the quality of information provided to the guardians , the level and prevalence of anxiety in children were low at WR time and significantly increased at OR time .


Botulinum toxin A products have been used in aesthetics for more than @ years .


To compare incobotulinumtoxinA with onabotulinumtoxinA in the treatment of crow 's feet .


This single-center , randomized , prospective , split-face , subject - and rater-blinded study with a clinical crossover evaluation comprised @ consecutive treatment cycles , each of @ months ' duration separated by @ months ( i.e. , a @-month treatment interval ) .


Fourteen subjects with symmetrical crow 's feet were assessed using the Merz @-point scale for crow 's feet , after each treatment with incobotulinumtoxinA ( right side of the face ) and onabotulinumtoxinA ( left side ) , or vice versa ( @:@ dose conversion ratio ) .


The treatment applied to each side of the face was reversed in Cycle @ .


Crow 's feet severity at rest and maximum contraction was improved to a similar extent by both treatments , in both cycles and on both sides of the face .


Pooled data confirmed these results .


Improvements were maintained at the final visit , @ months after treatment ( e.g. , left side at maximum contraction-onabotulinumtoxinA mean score : @ -LSB- baseline -RSB- vs @ -LSB- @ month -RSB- vs @ -LSB- @ months -RSB- ; incobotulinumtoxinA mean score : @ vs @ vs @ ) .


IncobotulinumtoxinA and onabotulinumtoxinA ( @:@ dose conversion ratio ) were well tolerated , showing comparable efficacy and duration of treatment effect for crow 's feet .


Meningococcal conjugate vaccines protect individuals directly , but can also confer herd protection by interrupting carriage transmission .


We assessed the effects of meningococcal quadrivalent glycoconjugate ( MenACWY-CRM ) or serogroup B ( @CMenB ) vaccination on meningococcal carriage rates in @-@-year-olds .


In this phase @ , observer-blind , randomised controlled trial , university students aged @-@ years from ten sites in England were randomly assigned ( @:@:@ , block size of three ) to receive two doses @ month apart of Japanese Encephalitis vaccine ( controls ) , @CMenB , or one dose of MenACWY-CRM then placebo .


Participants were randomised with a validated computer-generated random allocation list .


Participants and outcome-assessors were masked to the treatment group .


Meningococci were isolated from oropharyngeal swabs collected before vaccination and at five scheduled intervals over @ year .


Primary outcomes were cross-sectional carriage @ month after each vaccine course .


Secondary outcomes included comparisons of carriage at any timepoint after primary analysis until study termination .


Reactogenicity and adverse events were monitored throughout the study .


Analysis was done on the modified intention-to-treat population , which included all enrolled participants who received a study vaccination and provided at least one assessable swab after baseline .


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


Between Sept @ and Dec @ , @ , @ participants were randomly assigned ( @ assigned to control -LSB- @ analysed -RSB- , @ assigned to @CMenB -LSB- @ analysed -RSB- , @ assigned to MenACWY-CRM -LSB- @ analysed -RSB- ) ; @ % of the @CMenB group , @ % of the MenACWY-CRM group , and @ % of the control group were positive for meningococcal carriage at study entry .


By @ month , there was no significant difference in carriage between controls and @CMenB ( odds ratio @ , @ % CI @-@ ) or MenACWY-CRM ( @ , -LSB- @-@ -RSB- ) groups .


From @ months after dose two , @CMenB vaccination resulted in significantly lower carriage of any meningococcal strain ( @ % -LSB- @ % CI @-@ -RSB- carriage reduction ) , capsular groups BCWY ( @ % -LSB- @-@ -RSB- carriage reduction ) , capsular groups CWY ( @ % -LSB- @-@ -RSB- carriage reduction ) , and serogroups CWY ( @ % -LSB- @-@ -RSB- carriage reduction ) compared with control vaccination .


Significantly lower carriage rates were also noted in the MenACWY-CRM group compared with controls : @ % ( @ % CI @-@ ) carriage reduction for serogroup Y and @ % ( @-@ ) carriage reduction for serogroup CWY .


Study vaccines were generally well tolerated , with increased rates of transient local injection pain and myalgia in the @CMenB group .


No safety concerns were identified .


Although we detected no significant difference between groups at @ month after vaccine course , MenACWY-CRM and @CMenB vaccines reduced meningococcal carriage rates during @ months after vaccination and therefore might affect transmission when widely implemented .


Opioids have synergistic action with local anesthetics which may alter characteristics of epidural block .


Giving opioids to mother before delivery of baby is still fully not accepted with some fearing risk of neonatal depression .


Our primary aim was to evaluate the analgesic effect of addition of @ g fentanyl to epidural @ % bupivacaine in patients undergoing elective caesarean section using visual analog scale .


The secondary aim was to assess onset of analgesia , volume of drug required to achieve T@ level , grade and duration of motor block and Apgar score .


In this prospective , randomized , double blind , placebo controlled study @ patients scheduled for elective caesarean section under epidural anesthesia were randomly divided into two groups of @ each .


The fentanyl group received @ ml of @ g fentanyl and the saline group received @ ml of normal saline mixed with @ ml of @ % bupivacaine for epidural anesthesia .


VAS score , time to achieve T@ level , dose of bupivacaine , intraoperative analgesic consumption and duration of analgesia , grade and duration of motor block and any adverse maternal and neonatal effects were noted .


Data was analyzed using Students t test , chi-square test and Mann-Whitney U-test .


The values of P < @ were considered statistically significant .


Fentanyl improved the VAS score significantly ( @ ) compared to the saline group ( @ , P < @ ) .


It also reduced the intraoperaitve analgesic supplementation compared to the saline group .


( P = @ ) .


The postoperative duration of analgesia was prolonged in the fentanyl group ( @ min ) compared to the saline group ( @ min , P < @ ) .


The other characteristics of epidural block were unaltered .


Addition of @ g fentanyl to epidural @ % bupivacaine significantly reduces the VAS score .


It also reduces intra-operative analgesia supplementation and prolongs the duration of postoperative analgesia without altering the other characteristics of block .


The neonatal outcome is not affected with addition of fentanyl before delivery of baby .


Transurethral resection of prostate is the gold standard operation for bladder outflow obstruction due to benign prostatic enlargement .


However , catheter removal day is variable .


The objective of this study was to compare early and delayed catheter removal groups in terms of length of hospital stay , weight of resected prostate , duration of resection , peri-operative blood transfusion , and postoperative complications .


This randomized controlled trial was carried out in Urology Unit-B , Institute of Kidney Diseases Peshawar from @st September @ to @st July @ .


Patients were selected by simple random sampling technique after taking informed consent and divided into two groups : Group A-standard catheter removal group and Group B-early catheter removal group .


The study excluded patients with large post-void urine volume , simultaneous internal urethrotomy and transurethral resection of prostate , co-morbidity and intra-operative complications .


Patients were discharged after removal of catheter if they voided successfully .


In Group-A the catheters were kept for more than one day according to the standard protocol of our ward .


The data were analysed using SPSS-@ .


The study included @ patients , @ in Group-A and @ in Group-B .


Mean weight of resected tissue in Group-A was @ @ grams ; it was @ @ grams in group B. Mean catheter removal day was @ @ days in Group-A ; and @ @ days in Group-B .


Mean length of hospital stay was @ days @ in Group-A and @ days @ in Group-B ( p-value < @ ) .


Length of hospital stay strongly correlated with the day of catheter removal .


There was no significant difference between the two groups in terms of postoperative complications .


Removal of catheter on first postoperative day after transurethral prostatectomy does not increase the postoperative complications and results in shorter hospital stay .


To compare the effects of intrauterine lidocaine , intrauterine lidocaine plus rectal diclofenac , and a placebo on analgesia and to determine the satisfaction of patients and surgeons in cases of endometrial biopsy .


The double-blind , randomised , placebo-controlled study was conducted in the Department of Obstetrics and Gynaecology of the Ondokuz Mayis University , Samsun , Turkey , from April @ to January @ , and comprised patients scheduled for in-office endometrial biopsy.They were divided into three groups : Group P , @ml of @ % saline intrauterine ; Group L , @ml of @ % lidocaine intrauterine ; and Group LD , @ml of @ % lidocaine intrauterine @min before the procedure plus @mg of rectal diclofenac sodium .


Haemodynamic changes and visual analogue scale scores were recorded during the preoperative period , when the cervix was grasped with a tenaculum , immediately after intrauterine instillation , during uterine curettage and at postoperative @ min .


The patient and the surgeon were questioned about their satisfaction @ min after the procedure .


SPSS @ was used for statistical analysis .


The @ patients in the study were divided into three equal groups of @ ( @ % ) each .


There were no statistically significant inter-group differences in age , bodyweight , parity , number of postmenopausal patients , haemodynamic parameters and American Society of Anesthesiologists scores ( p > @ in all categories ) .


In Group P , the visual analogue scale score estimated when the cervix was grasped with the tenaculum was lower when compared with Group L and Group LD ( p = @ and p = @ , respectively ) .


At other measurement time points , the scores did not differ between the groups .


The groups did not differ with respect to patient and surgeon satisfaction and complication rates ( p > @ ) .


Intrauterine lidocaine or intrauterine lidocaine plus rectal diclofenac application had no effect on visual analogue scale scores , patient satisfaction and vasovagal reaction .


To determine the effect of dantrolene premedication on various cardiovascular and biochemical variables and recovery in isoflurane-anesthetized horses .


@ healthy horses .


Each horse was anesthetized twice with a @ - to @-day washout period between anesthetic sessions .


Food was not withheld from horses before either session .


During each session , dantrolene ( @ mg/kg in @ L of water ) or water ( @ L ) was administered via a nasogastric tube @ hour before anesthesia was induced .


Anesthesia was maintained with isoflurane for @ minutes , during which blood gas analyses and lithium-dilution cardiac output ( CO ) measurements were obtained every @ minutes .


Serum creatine kinase activity was measured before and at @ , @ , and @ hours after anesthesia .


When horses were premedicated with dantrolene , CO at @ , @ , and @ minutes after induction of anesthesia was significantly lower than that when horses were premedicated with water after which time difficulty in obtaining valid measurements suggested a continued decrease in CO ; plasma potassium concentration progressively increased during anesthesia , whereas serum creatine kinase activity remained fairly stable and within reference limits through @ hours after anesthesia ; and @ of @ horses developed cardiac arrhythmias that required medical intervention .


The quality of anesthetic recovery was slightly better when horses were premedicated with dantrolene versus water , although the time required for recovery did not differ significantly between treatments .


Results suggested that dantrolene premedication prevented muscle damage without affecting anesthetic recovery but impaired CO and precipitated hyperkalemia and cardiac arrhythmias in healthy isoflurane-anesthetized horses .


Co-occurring mental and substance use disorders are associated with worse outcomes than a single disorder alone .


In this exploratory subgroup analysis of a randomized trial , the authors hypothesized that providing chronic care management ( CCM ) for substance dependence in a primary care setting would have a beneficial effect among persons with substance dependence and major depressive disorder or posttraumatic stress disorder ( PTSD ) .


Adults ( N = @ ) with alcohol dependence , drug dependence , or both were assigned to CCM or usual primary care .


CCM was provided by a nurse care manager , social worker , internist , and psychiatrist .


Clinical outcomes ( any use of opioids or stimulants or heavy drinking and severity of depressive and anxiety symptoms ) and treatment utilization ( emergency department use and hospitalization ) were measured at three , six , and @ months after enrollment .


Longitudinal regression models were used to compare randomized arms within the subgroups of participants with major depressive disorder or PTSD .


Among all participants , @ % met criteria for major depressive disorder and @ % met criteria for PTSD at baseline .


No significant effect of CCM was observed within either subgroup for any outcome , including any use of opioids or stimulants or heavy drinking , depressive symptoms , anxiety symptoms , and any hospitalizations or number of nights hospitalized .


Among participants with depression , those receiving CCM had fewer days in the emergency department compared with the control group , but the finding was of only borderline significance ( p = @ ) .


Among patients with co-occurring substance dependence and mental disorders , CCM was not significantly more effective than usual care for improving clinical outcomes or treatment utilization .


The World Health Organization ( WHO ) has in @ changed the diagnostic criteria for gestational diabetes mellitus ( GDM ) to acknowledge the putative effect of mildly elevated fasting plasma glucose ( FPG ) levels on pregnancy outcomes .


We aimed to determine the prevalence and risk factors of GDM comparing the previous WHO @ criteria to the WHO @ criteria in North India .


In a population-based screening programme , @ randomly selected North Indian women were studied using a cross-sectional design with a questionnaire , venous FPG and @-h capillary plasma glucose ( PG ) after a @ g oral glucose tolerance test performed between @ and @ weeks of pregnancy .


The prevalence of GDM was @ % using WHO @ criteria vs @ % using WHO @ criteria .


FPG measurements identified @ % of WHO @ GDM cases as opposed to @ % of WHO @ GDM cases .


In contrast , @-h PG measurements identified only @ % of WHO @ GDM cases compared with @ % of the WHO @ GDM cases .


Using logistic regression with backward elimination , urban habitat , illiteracy , non-vegetarianism , increased BMI , Hindu religion and low adult height were all independent risk factors of GDM using the @ criteria , whereas only urban habitat , low adult height and increased age were independent risk factors of GDM using the @ criteria .


Intervention studies are needed to justify the WHO @ GDM criteria increasing the prevalence four fold to include more than one third of North Indian pregnant women .


Methylnaltrexone bromide ( MTNX ) is a peripherally acting mu-opioid receptor antagonist , prescribed for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care .


Studies have used this drug to determine if other opioid-induced effects besides constipation are altered by MTNX in humans and have suggested , based on their results , that these other effects are altered by peripheral opioid actions .


The primary objective of this report is to present results that provide indirect evidence that MTNX has centrally mediated effects , albeit slight , and secondarily to describe the effects of MTNX on psychopharmacological effects of morphine .


In a crossover , randomized , placebo-controlled , double-blind study , @ healthy volunteers received @ mg/kg MTNX or saline subcutaneously , followed by saline intravenously .


In three other conditions , @ mg/kg of morphine sulfate administered intravenously was preceded by subcutaneous administration of @ , @ , or @ mg/kg MTNX .


Before and after drug administration , subjective and physiological measures , including pupil diameter , were assessed .


Two separate analyses confirmed that @ mg/kg MTNX alone induced a slight degree of miosis , a centrally mediated opioid agonist effect .


This dose had minimal subjective effects .


MTNX at either or both the @ and @ mg/kg dose reduced some subjective effects of morphine without altering miosis .


We present indirect evidence that MTNX crosses the blood-brain barrier in humans .


Therefore , whether the reductions in subjective effects of morphine by MTNX that were observed in past studies and in this study can be attributed to peripheral mechanisms is open to question .


The direct-acting platelet P@Y@ receptor antagonist ticagrelor can reduce the incidence of major adverse cardiovascular events when administered at hospital admission to patients with ST-segment elevation myocardial infarction ( STEMI ) .


Whether prehospital administration of ticagrelor can improve coronary reperfusion and the clinical outcome is unknown .


We conducted an international , multicenter , randomized , double-blind study involving @ patients with ongoing STEMI of less than @ hours ' duration , comparing prehospital ( in the ambulance ) versus in-hospital ( in the catheterization laboratory ) treatment with ticagrelor .


The coprimary end points were the proportion of patients who did not have a @ % or greater resolution of ST-segment elevation before percutaneous coronary intervention ( PCI ) and the proportion of patients who did not have Thrombolysis in Myocardial Infarction flow grade @ in the infarct-related artery at initial angiography .


Secondary end points included the rates of major adverse cardiovascular events and definite stent thrombosis at @ days .


The median time from randomization to angiography was @ minutes , and the median time difference between the two treatment strategies was @ minutes .


The two coprimary end points did not differ significantly between the prehospital and in-hospital groups .


The absence of ST-segment elevation resolution of @ % or greater after PCI ( a secondary end point ) was reported for @ % and @ % of the patients , respectively .


The rates of major adverse cardiovascular events did not differ significantly between the two study groups .


The rates of definite stent thrombosis were lower in the prehospital group than in the in-hospital group ( @ % vs. @ % in the first @ hours ; @ % vs. @ % at @ days ) .


Rates of major bleeding events were low and virtually identical in the two groups , regardless of the bleeding definition used .


Prehospital administration of ticagrelor in patients with acute STEMI appeared to be safe but did not improve pre-PCI coronary reperfusion .


( Funded by AstraZeneca ; ATLANTIC ClinicalTrials.gov number , NCT@ . )


Despite being a critical survivorship care issue , there is a clear gap in current knowledge of the optimal treatment of sexual dysfunction in men with prostate cancer .


There is sound theoretical rationale and emerging evidence that exercise may be an innovative therapy to counteract sexual dysfunction in men with prostate cancer .


Furthermore , despite the multidimensional aetiology of sexual dysfunction , there is a paucity of research investigating the efficacy of integrated treatment models .


Therefore , the purpose of this study is to : @ ) examine the efficacy of exercise as a therapy to aid in the management of sexual dysfunction in men with prostate cancer ; @ ) determine if combining exercise and brief psychosexual intervention results in more pronounced improvements in sexual health ; and @ ) assess if any benefit of exercise and psychosexual intervention on sexual dysfunction is sustained long term .


A three-arm , multi-site randomised controlled trial involving @ prostate cancer survivors will be implemented .


Participants will be randomised to : @ ) ` Exercise ' intervention ; @ ) ` Exercise + Psychosexual ' intervention ; or @ ) ` Usual Care ' .


The Exercise group will receive a @-month , group based , supervised resistance and aerobic exercise intervention .


The Exercise + Psychosexual group will receive the same exercise intervention plus a brief psychosexual self-management intervention that addresses psychological and sexual well-being .


The Usual Care group will maintain standard care for @ months .


Measurements for primary and secondary endpoints will take place at baseline , @ months ( post-intervention ) and @ year follow-up .


The primary endpoint is sexual health and secondary endpoints include key factors associated with sexual health in men with prostate cancer .


Sexual dysfunction is one of the most prevalent and distressing consequences of prostate cancer .


Despite this , very little is known about the management of sexual dysfunction and current health care services do not adequately meet sexual health needs of survivors .


This project will examine the potential role of exercise in the management of sexual dysfunction and evaluate a potential best-practice management approach by integrating pharmacological , physiological and psychological treatment modalities to address the complex and multifaceted aetiology of sexual dysfunction following cancer .


In the context of multiple adversities , women are demonstrating resilience in rebuilding their futures , through participation in microfinance programs .