Among young persons with chronic migraine , the use of CBT plus amitriptyline resulted in greater reductions in days with headache and migraine-related disability compared with use of headache education plus amitriptyline .


These findings support the efficacy of CBT in the treatment of chronic migraine in children and adolescents .


clinicaltrials.gov Identifier : NCT00389038 .


Interventions targeting sedentary time are needed .


We used detailed EMG recordings to study the short-term effectiveness of simple sedentary time-targeted tailored counseling on the total physical activity spectrum .


This cluster randomized controlled trial was conducted between 2011 and 2013 ( InPact , ISRCTN28668090 ) , and short-term effectiveness of counseling is reported in the present study .


A total of 133 office workers volunteered to participate , from which muscle activity data were analyzed from 48 ( intervention , n = 24 ; control , n = 24 ) .


After a lecture , face-to-face tailored counseling was used to set contractually binding goals regarding breaking up sitting periods and increasing family based physical activity .


Primary outcome measures were assessed 11.8 1.1 h before and a maximum of 2 wk after counseling including quadriceps and hamstring muscle inactivity time , sum of the five longest muscle inactivity periods , and light muscle activity time during work , commute , and leisure time .


Compared with those in the controls , counseling decreased the intervention group 's muscle inactivity time by 32.6 71.8 min from 69.1 % 8.5 % to 64.6 % 10.9 % ( whole day , P < 0.05 ; work , P < 0.05 ; leisure , P < 0.05 ) and the sum of the five longest inactivity periods from 35.6 14.8 to 29.7 10.1 min ( whole day , P < 0.05 ; leisure , P < 0.01 ) .


Concomitantly , light muscle activity time increased by 20.6 52.6 min , from 22.2 % 7.9 % to 25.0 % 9.7 % ( whole day , P < 0.05 ; work , P < 0.01 ; leisure , P < 0.05 ) , and during work time , average EMG amplitude ( percentage of EMG during maximal voluntary isometric contraction ( MVC ) ( % EMG MVC ) ) increased from 1.6 % 0.9 % to 1.8 % 1.0 % ( P < 0.05 ) in the intervention group compared with that in the controls .


A simple tailored counseling was able to reduce muscle inactivity time by 33 min , which was reallocated to 21 min of light muscle activity .


During work time , average EMG amplitude increased by 13 % , reaching an average of 1.8 % of EMG MVC .


If maintained , this observed short-term effect may have health-benefiting consequences .


To compare the diagnostic performance of adaptive statistical iterative reconstruction applied low-dose computed tomography ( CT ) ( LDCT ) with that of the standard-dose CT ( SDCT ) for local recurrence in patients with stomach cancer .


Seventy-nine consecutive patients who had undergone surgical resection for stomach cancer were enrolled .


To monitor recurrence , SDCT ( 120 kilovolt peak [ kVp ] , 200mAs ) had been performed .


The LDCT ( 120 kVp , 100 mA s ) was taken , and images were reconstructed with 4 levels of adaptive statistical iterative reconstruction ( ASIR ) blending ( 0 % , 30 % , 50 % , and 70 % ) .


Two blinded radiologists recorded the diagnostic confidence scores for local recurrence in each data set using a 5-point scale .


Endoscopic biopsy results served as the reference standard .


Receiver operating characteristic ( ROC ) curve analysis was used to calculate the diagnostic performance .


The diagnostic performance of LDCT with variable ASIR blending ratios was comparable to that of SDCT ( area under ROC curve , 0.727-0 .734 , 0.687 , respectively , P > 0.05 ) .


The diagnostic performance of ASIR applied LDCT is comparable to that of SDCT .


To evaluate and compare the shear bond strength ( SBS ) of stainless steel and gold-plated attachments to impacted lower third molars in vivo and in vitro with a light-cured orthodontic resin .


Sixteen patients with bilaterally full soft tissue impaction of lower third molars were recruited on a voluntary basis from an oral and maxillofacial surgery department .


A split-arch technique was used .


Following surgical exposure of the crown , the tooth was luxated but not extracted .


Then , two attachments ( one stainless steel button and one gold-plated eyelet ) were bonded to the labial enamel surface of the loosened tooth .


Five minutes later , the luxated tooth was removed from its socket .


In each patient , the impacted tooth on the other side was extracted , and attachments were bonded in vitro .


The SBSs of the attachments were evaluated .


For comparison , analysis of variance and multiple range tests were used ( = 0.05 ) .


Statistically significant differences were evident in attachment adhesion to the impacted tooth surfaces among the four groups ( p < 0.001 ) .


Superior SBS values were obtained for stainless steel button groups bonded in vitro .


The mean bond strengths of the groups bonded in vitro were better than those of the same groups bonded in vivo .


Although the in vitro-bonded groups showed higher SBS values , adequate bond strength is possible with stainless steel buttons bonded in vivo .


The current study evaluated the costs and benefits of a simple aerobic walking program for patients with chronic obstructive pulmonary disease ( COPD ) .


This was a blinded randomized controlled clinical trial that recruited 72 patients diagnosed with COPD , 40 of whom were included in the study and divided into two groups [ control group ( CG ) and pulmonary rehabilitation group ( GPR ) ] .


We assessed pulmonary function , distance covered during the 6-minute walk test ( 6MWT ) , respiratory and peripheral muscle strength , health-related quality of life ( HRQOL ) , body composition , and level of activities of daily living ( ADLs ) before and after an 8-week walking program .


The financial costs were calculated according to the pricing table of the Brazilian Unified Health System ( SUS ) .


Only 34 of the 40 patients remained in the final sample ; 16 in the CG and 18 in the GPR ( FEV1 : 50.9 14 % predicted and FEV1 : 56 0.5 % predicted , respectively ) .


The intervention group exhibited improvements in the 6MWT , sensation of dyspnea and fatigue , work performed , BODE index ( p < 0.01 ) , HRQOL , ADL level ( p < 0.001 ) , and lower limb strength ( p < 0.05 ) .


The final mean cost per patient for the GPR was R$ 148.75 ( ~ US$ 75.00 ) and no patient significantly exceeded this value .


However , 2 patients in the CG did exceed this value , incurring a cost of R$ 689.15 ( ~ US$ 345.00 ) .


Aerobic walking demonstrated significant clinical benefits in a cost-efficient manner in patients with COPD .


The purpose of this study was to conduct a randomized trial of radiation therapy for plantar fasciitis and to compare radiation therapy with local steroid injections .


Between March 2013 and April 2014 , 128 patients with plantar fasciitis were randomized to receive radiation therapy ( total dose of 6.0 Gy applied in 6 fractions of 1.0 Gy three times a week ) or local corticosteroid injections a 1 ml injection of 40 mg methylprednisolone and 0.5 ml 1 % lidocaine under the guidance of palpation .


The results were measured using a visual analog scale , a modified von Pannewitz scale , and a 5-level function score .


The fundamental phase of the study was 3 months , with a follow-up period of up to 6 months .


The median follow-up period for all patients was 12.5 months ( range , 6.5-18 .6 months ) .


For the radiation therapy patients , the median follow-up period was 13 months ( range , 6.5-18 .5 months ) , whereas in the palpation-guided ( PG ) steroid injection arm , it was 12.1 months ( range , 6.5-18 .6 months ) .


After 3 months , results in the radiation therapy arm were significantly superior to those in the PG steroid injection arm ( visual analog scale , P < .001 ; modified von Pannewitz scale , P < .001 ; 5-level function score , P < .001 ) .


Requirements for a second treatment did not significantly differ between the 2 groups , but the time interval for the second treatment was significantly shorter in the PG steroid injection group ( P = .045 ) .


This study confirms the superior analgesic effect of radiation therapy compared to mean PG steroid injection on plantar fasciitis for at least 6 months after treatment .


Dispatcher-assisted CPR ( DA-CPR ) can increase rates of bystander CPR , survival , and quality of life following cardiac arrest .


Dispatcher protocols designed to improve rapid recognition of arrest and coach CPR may increase survival by ( 1 ) reducing preventable time delays to start of chest compressions and ( 2 ) improving the quality of bystander CPR .


We conducted a randomized controlled trial comparing a simplified DA CPR script to a conventional DA CPR script in a manikin cardiac arrest simulation with lay participants .


The primary outcomes measured were the time interval from call receipt to the first chest compression and the core metrics of chest compression ( depth , rate , release , and compression fraction ) .


CPR was measured using a recording manikin for the first 3 min of participant CPR .


Of the 75 participants , 39 were randomized to the simplified instructions and 36 were randomized to the conventional instructions .


The interval from call receipt to first compression was 99 s using the simplified script and 124 s using the conventional script for a difference of 24s ( p < 0.01 ) .


Although hand position was judged to be correct more often in the conventional instruction group ( 88 % versus 63 % , p < 0.01 ) , compression depth was an average 7 mm deeper among those receiving the simplified CPR script ( 32 mm versus 25 mm , p < 0.05 ) .


No statistically significant differences were detected between the two instruction groups for compression rate , complete release , number of hands-off periods , or compression fraction .


Simplified DA-CPR instructions to lay callers in simulated cardiac arrest settings resulted in significant reductions in time to first compression and improvements in compression depth .


These results suggest an important opportunity to improve DA CPR instructions to reduce delays and improve CPR quality .


Calcium intake during growth is essential for future bone health but varies widely between individuals and populations .


The impact on bone of increasing calcium intake is unknown in a population where low calcium intake , stunting , and delayed puberty are common .


To determine the effect of prepubertal calcium supplementation on mean age at peak velocity for bone growth and mineral accrual .


Prospective follow-up of boys in rural Gambia , West Africa , who had participated in a double-blind , randomized , placebo-controlled trial of calcium supplementation .


Eighty boys , initially aged 8.0-11 .9 years , were followed up for 12 years .


Subjects received 1 year of calcium carbonate supplementation ( 1000 mg daily , 5 d/wk ) .


Dual-energy x-ray absorptiometry measurements were carried out for whole body ( WB ) , lumbar spine , and total hip bone mineral content , bone area ( BA ) , and WB lean mass .


Super imposition by translation and rotation models was made to assess bone growth .


Age at peak velocity was consistently earlier in the calcium group compared to the placebo group , for WB bone mineral content ( mean , -6.2 [ SE , 3.1 ] ; P = .05 ) , WB BA ( mean , -7.0 [ SE , 3.2 ] mo ; P = .03 ) , lumbar spine and total hip BA .


By young adulthood , supplementation did not change the amount of bone accrued ( mineral or size ) or the rate of bone growth .


Twelve months of prepubertal calcium carbonate supplementation in boys with a low calcium diet advanced the adolescent growth spurt but had no lasting effect on bone mineral or bone size .


There is a need for caution when applying international recommendations to different populations .


To evaluate the long-term clinical outcomes of fractional flow reserve ( FFR ) - guided versus intravascular ultrasound ( IVUS ) - guided percutaneous coronary intervention ( PCI ) for intermediate coronary lesions .


A total of 226 patients with 293 intermediate coronary artery lesions ( stenosis of 40 % -70 % ) confirmed by coronary angiography were randomized into 3 groups to undergo PCI for a minimal lumen cross sectional area ( MLA ) < 4 mm ( 2 ) ( IVUS group , 98 lesions ) or for a FFR < 0.80 ( FFR group , 101 lesions ) , or to receive standard medical treatment ( medication group , 94 lesions ) .


The primary outcome was major adverse cardiac events including death , myocardial infarction , and ischemia-driven target vessel revascularization at 1 year after the index procedure .


The baseline percent diameter stenosis and lesion length were similar between the 3 groups , but more patients in IVUS group than in FFR group received PCI ( P < 0.001 ) .


No significant difference was found in the incidence of major adverse cardiac events between the 3 groups ( P = 0.182 ) .


Both FFR - and IVUS-guided PCI strategy for intermediate coronary artery disease are associated with favorable outcomes , but IVUS-guided PCI based on the single index of MLA can increase the rate of revascularization therapy .


Thalassemia major is the most common genetic disorder in Pakistan .


The study was done to compare the efficacy and safety of the deferiprone with deferrioxamine for the treatment of iron overload in children with thalassemia major .


This randomized controlled trail was conducted at thalassemia blood transfusion unit of Allied Hospital , Faisalabad ( AHF ) / District Headquarter Hospital ( DHQ ) , Faisalabad .


Thalassemia-Unit Hilal-e-Ahmar , Alizeb Foundation and Blood Bank Services Faisalabad from November 2010 to December 2011 .


Children with beta thalassemia major of age more than 2 years and less than 16 years with transfusion iron over load were randomly allocated to one of the two groups each comprising of 67 patients .


One group received deferiprone given at a daily dose of 75mg/kg in three divided doses orally while the other group received deferrioxamine at dose 50 mg/kg/24hrs for 5 days/week as parental infusion .


Changes in the serum ferritin level were assessed .


Cardiac function and toxicity were also examined .


Serum ferritin was significantly reduced after 1 year in both treatment arms ( p = 0.01 ) .


Neutropenia observed in 13 ( 19.40 % ) non-splenectomized patients taking deferiprone .


Transient elevations in ALT were observed in 3 ( 4.47 % ) children taking deferiprone .


Left ventricular ejection fraction ( LVEF ) remained in normal range in both treatment arm but has decreased significantly in Deferrioxamine group compliance .


Compliance was better in deferiprone as compared to deferrioxamine .


Discontinuing percentage 2 ( 3 % ) vs 9 ( 13.43 % ) .


Deferiprone is a highly efficacious and safe chelation therapy for patients with thalassemia major who are non-compliant to Deferrioxamine .


Deferiprone have an efficacy profile comparable to standard Deferrioxamine .


The objective of the present study was to develop population pharmacokinetic models for olmesartan medoxomil and hydrochlorothiazide and to investigate the influence of demographic factors on these population pharmacokinetics .


Plasma concentrations of olmesartan medoxomil and hydrochlorothiazide were measured in 41 healthy volunteers enrolled in our bioequivalence study by LC-MS/MS following oral administration of an olmesartan medoxomil/hydrochlorothiazide ( 20/12 .5 mg ) fixed-dose combination tablet .


This data and covariates were subjected to nonlinear mixed-effect modeling analysis using the NONMEM software .


Evaluation featured a visual predicted check and bootstrapping .


The distributions of olmesartan medoxomil and hydrochlorothiazide were best fitted using a two-compartment model with no lag time and first-order elimination .


When analyzing hydrochlorothiazide kinetics , we found that TCHO and CL/F were correlated , while .


HB and Ka influenced olmesartan medoxomil modeling .


All evaluations indicated that the pharmacokinetic profiles of olmesartan medoxomil and hydrochlorothiazide were adequately described using our PPK model .


This study indicates that demographic factors influence the inter-individual variability in the disposition of the combination drug , and it might be more useful to apply it to the PK of olmesartan medoxomil/hydrochlorothiazide ( 20/12 .5 mg ) FDC tablets administered to patients with hypertension .


* These two authors contributed equally to this work .


Physician-coded verbal autopsy ( PCVA ) is the most widely used method to determine causes of death ( CODs ) in countries where medical certification of death is uncommon .


Computer-coded verbal autopsy ( CCVA ) methods have been proposed as a faster and cheaper alternative to PCVA , though they have not been widely compared to PCVA or to each other .


We compared the performance of open-source random forest , open-source tariff method , InterVA-4 , and the King-Lu method to PCVA on five datasets comprising over 24,000 verbal autopsies from low - and middle-income countries .


Metrics to assess performance were positive predictive value and partial chance-corrected concordance at the individual level , and cause-specific mortality fraction accuracy and cause-specific mortality fraction error at the population level .


The positive predictive value for the most probable COD predicted by the four CCVA methods averaged about 43 % to 44 % across the datasets .


The average positive predictive value improved for the top three most probable CODs , with greater improvements for open-source random forest ( 69 % ) and open-source tariff method ( 68 % ) than for InterVA-4 ( 62 % ) .


The average partial chance-corrected concordance for the most probable COD predicted by the open-source random forest , open-source tariff method and InterVA-4 were 41 % , 40 % and 41 % , respectively , with better results for the top three most probable CODs .


Performance generally improved with larger datasets .


At the population level , the King-Lu method had the highest average cause-specific mortality fraction accuracy across all five datasets ( 91 % ) , followed by InterVA-4 ( 72 % across three datasets ) , open-source random forest ( 71 % ) and open-source tariff method ( 54 % ) .


On an individual level , no single method was able to replicate the physician assignment of COD more than about half the time .


At the population level , the King-Lu method was the best method to estimate cause-specific mortality fractions , though it does not assign individual CODs .


Future testing should focus on combining different computer-coded verbal autopsy tools , paired with PCVA strengths .


This includes using open-source tools applied to larger and varied datasets ( especially those including a random sample of deaths drawn from the population ) , so as to establish the performance for age - and sex-specific CODs .


The cause of infertility is unexplained or poorly explained in 30-40 % of couples undergoing standard investigations , and treatment ranges from expectant management to IUI and IVF .


The aim of this study was to compare the clinical pregnancy rates and costs of intra-uterine insemination ( IUI ) and in vitro fertilisation ( IVF ) in women where the same ovarian stimulation led to the development of two or three mature follicles .


A randomised controlled clinical trial compared the efficacy of IUI and IVF in a tertiary fertility centre ( ISRCTN28780587 ) .


Primary outcome measures were fetal heart positive pregnancy rate and cost per live birth .


The selection criteria were age : females 18-42years and males 18-60years , infertility for one year or more , no IVF or IUI for 12months prior to the trial , and no coital , tubal or ovulatory disorders , oligospermia , untreated endometriosis or contraindication for multiple pregnancy .


All women ( n = 102 ) had the same dose FSH stimulation protocol .


Those who developed two or three preovulatory follicles were randomised 3:1 to IUI ( n = 33 ) or IVF ( n = 10 ) .


IUI or IVF was performed 36h after hCG administration with single or double embryo transfer on day two .


Clinical pregnancy rates ( 40 % vs 12 % , P = 0.04 ) and live birth rate ( 40 % vs 6 % , P = 0.01 ) were higher for IVF than IUI .


The cost per live birth was AU$ 8735 for IVF compared with $ 42,487 for IUI .


This study provides evidence that IVF is more successful and cost-effective than IUI using the same doses of FSH .


Further confirmatory studies are required .


Given verapamil 's property as a glycoprotein inhibitor , this drug could increase the effective concentration of antiepileptic drugs ( AEDs ) in the epileptic foci , reducing the number of seizures .


This pilot study was designed to evaluate the safety and efficacy of verapamil as adjunct therapy in pharmacoresistant patients with focal onset seizures .


This was a single-centered , randomized , double-blind and placebo-controlled trial evaluating verapamil as an add-on therapy for adult patients with refractory epilepsy .


Twenty-two patients were randomized , but five of them withdrew and one patient passed away after consent , having no exposure to either verapamil or placebo ; four patients withdrew during or after the double-blind phase due to side effects .


From these four patients , only one patient was in the verapamil group .


Twelve patients ( 59 % ) finished the study .


Some patients experienced lower seizure frequencies , but none of them reached 50 % reduction .


In addition , there was no statistically significant decrease in the seizure frequency of patients receiving verapamil .


When comparing the verapamil with the placebo at the double-blind or the open label study phases , the average difference in seizure range also failed to show significance ( p = 0.41 and p = 0.98 , respectively ) .


No significant cardiovascular effects were observed , and side effects unique to verapamil were skin rashes and feet edema .


Throughout the study , carbamazepine , valproic acid and clobazam levels increased following verapamil intake ; minor dosage adjustment was required in one patient on carbamazepine .


This pilot study has shown mild benefits of verapamil use in comparison to placebo as an add-on therapy for a group of non-selected patients with refractory epilepsy .


A partial response in a subset of patients was seen .


No significant safety problems happened , but adjustments on AEDs may be required during verapamil use .


Depression has been widely studied in primary care settings , yet studies of medically uninsured populations are lacking .


We sought to determine whether depression screening and treatment improved depression scores of a medically uninsured , mostly African American primary care population .


The study was a prospective repeated-measures design that recruited uninsured patients .


Patients were screened for depression , and the rate of depression diagnosis was compared with baseline .


Patients who were diagnosed and accepted treatment were randomized to 1 of 4 treatment arms : ( 1 ) usual care ; ( 2 ) usual care and psychotherapy ; ( 3 ) usual care and education and psychotherapy ; and ( 4 ) usual care and education .


Patients were then reevaluated at 8 , 12 , and 24 weeks .


A total of 674 patients participated .


Depression prevalence was significantly higher among those screened ( 38 % ) than at baseline ( 16 % ) .


All treatment groups showed a significant reduction in depression scores over a 6-month period , from a mean score of 15 at baseline to 8.3 at 24 weeks ( P < .005 ) .


All treatment interventions were equally effective .


Screening improves the rate of diagnosis of depression in an uninsured , primarily African American population , and subsequent treatment significantly reduces the burden of depression .


In patients with resistant hypertension ( RH ) and obstructive sleep apnea ( OSA ) , the blood pressure response to continuous positive airway pressure ( CPAP ) treatment is highly variable and could be associated with differential micro-ribonucleic acid ( miRNA ) profiles .


Currently , no available methods exist to identify patients who will respond favorably to CPAP treatment .


The aim of this study was to identify plasma miRNA profiles that predict blood pressure responses to CPAP treatment .


Cardiovascular system-focused circulating miRNA expression was evaluated in plasma samples using an 84-miRNA array among patients with RH and OSA at baseline and after 3 months of adherent CPAP use .


Pathway analysis and miRNA target gene enrichment were performed in silico .


Plasma levels of peptides and hormones related to cardiovascular function were also measured .


The OSA responder group exhibited blood pressure decreases exceeding the observed median ( > 4.5 mm Hg ) after CPAP , which were not present in the nonresponder group ( 4.5 mm Hg ) ( p < 0.01 ) .


Three miRNAs provided a discriminatory predictive model for such a favorable blood pressure response to CPAP ( area under the curve : 0.92 ; p = 0.01 ) .


Additionally , CPAP treatment significantly altered a total of 47 plasma miRNAs and decreased aldosterone-to-renin ratios in the responder group ( p = 0.016 ) but not in the nonresponder group .


A singular pre-CPAP treatment cluster of 3 plasma miRNAs predicts blood pressure responses to CPAP treatment in patients with RH and OSA .


CPAP treatment is accompanied by changes in cardiovascular system-related miRNAs that may potentially influence the risk for cardiovascular disease among patients with OSA and RH .


( Effect of Continuous Positive Airway Pressure [ CPAP ] Treatment in the Control of Refractory Hypertension ; NCT00616265 ) .


To evaluate and compare the effects of single intravitreal injection of ranibizumab and bevacizumab on central retinal and choroidal thickness in patients with neovascular age-related macular degeneration ( AMD ) .


Forty eyes of 40 patients with neovascular AMD that underwent intravitreal injection of vascular endothelial growth factor inhibitors ( anti-VEGFs ) were included .


Patients were randomized into 2 groups : 20 eyes received ranibizumab and 20 eyes received bevacizumab injection .


Central retinal and choroidal thicknesses of all eyes at baseline and 1 month postinjection scans were measured with Fourier-domain optical coherence tomography ( OCT ) .


Student t test and Mann-Whitney U test were used to compare the data .


The mean central retinal thickness ( CRT ) showed significant decrease after single injection of ranibizumab ( from 345.0 m to 253.5 m , p < 0.01 ) and bevacizumab ( from 329.5 m to 251.0 m , p < 0.01 ) at the first month , respectively .


There was no significant difference regarding the CRT change between groups ( p = 0.39 ) .


The mean choroidal thickness decreased from 158.6 m ( 115-317 ) to 155.5 m ( 111-322 ) in the ranibizumab group and from 211.5 m ( 143-284 ) to 201.5 m ( 93-338 ) in bevacizumab group .


The decrease was not significant between groups ( p = 0.35 ) .


Intravitreal injection of both ranibizumab and bevacizumab provided a significant decrease in CRT ; however , the agents caused no significant change in choroidal thickness .


Additionally , no difference between ranibizumab versus bevacizumab was observed related to macular edema inhibition .


To evaluate the effect of intraoperative low-dose ketamine with general anesthesia on postoperative pain after total knee replacement surgery .


A randomized , double-blind comparative study .


Ankara Numune Training and Research Hospital , Turkey , from January and June 2011 .


Sixty adults undergoing total knee arthroplasty were enrolled in this study .


The patients were randomly allocated into two groups of equal size to receive either racemic ketamine infusion ( 6 g/kg/minute ) or the same volume of saline .


A visual analogue scale ( VAS ) was used to measure each patient 's level of pain at 1 , 3 , 6 , 12 , and 24 hours after surgery .


Time to first analgesic request , postoperative morphine consumption and the incidence of side effects were also recorded .


Low-dose ketamine infusion prolonged the time to first analgesic request .


It also reduced postoperative cumulative morphine consumption at 1 , 3 , 6 , 12 , and 24 hours postsurgery ( p < 0.001 ) .


Postoperative VAS scores were also significantly lower in the ketamine group than placebo , at all observation times .


Incidences of side effects were similar in both study groups .


Intraoperative continuous low-dose ketamine infusion reduced pain and postoperative analgesic consumption without affecting the incidence of side effects .


AZD9164 has demonstrated potential as an inhaled , long-acting , muscarinic antagonist ( LAMA ) bronchodilator .


However , in patients with COPD , but not in healthy subjects , a transient initial drop in FEV1 was observed following inhalation of nebulised doses of AZD9164 in citrate buffer.Two additional studies were conducted to further assess the safety and tolerability of multiple ascending doses of AZD9164 in 27 white and 18 Japanese healthy subjects and in 4 patients with COPD .


In these studies , AZD9164 was inhaled via Turbuhaler .


These were Phase I , randomised , double-blind , placebo-controlled , multiple ascending dose ( MAD ) studies conducted in Sweden and UK .


Healthy subjects ( mean age 25.9 yrs ) and patients with COPD ( mean age 66 yrs , mean post-bronchodilator FEV1 60.1 % predicted normal value ) were randomised 2:1 to active treatment ( 400 , 1000 or 2800 g delivered doses of AZD9164 ) or placebo .


No safety or tolerability concerns were identified in the healthy subjects at doses up to and including 2800 g and both studies confirmed the bronchodilator effect of AZD9164 .


However , the first 3 patients in the COPD cohort who received AZD9164 ( 1000 g ) experienced a transient fall in FEV1 5 to 15 minutes after inhalation of AZD9164 while the patient receiving placebo did not .


The study safety review process then resulted in cessation of further activities on AZD9164 .


Retrospective analysis showed that two healthy subjects had also had transient falls in FEV1 shortly after inhalation of AZD9164 400 and 2800 g respectively , although neither reported any related respiratory symptoms or other AEs .


These results show that transient paradoxical bronchoconstriction can occur in some healthy subjects , in addition to patients with COPD , following inhalation of AZD9164 and that the citrate buffer used in the nebulised formulation can not have been the only cause of the drop in FEV1 in previous studies .


As preclinical data do not provide an explanation , the reasons for this brief post-dose drop in FEV1 remain unclear .


However , these results highlight the importance of monitoring lung function immediately post-dose when investigating novel inhaled treatments , even when a rapid onset of effect is not expected .


Clinicaltrials.gov NCT01016951 and NCT01096563 .


Testosterone ( T ) administration to men increases T , estradiol ( E2 ) , dihydrotestosterone ( DHT ) , and fat-free mass ( FFM ) , and decreases fat mass ( FM ) but does not consistently improve insulin sensitivity ( IS ) .


The aim of this study was to examine the effects of T administration in obese , nondiabetic men on body composition and IS , and to determine if inhibition ( i ) of metabolism of T to E2 with anastrazole or to DHT with dutasteride alters these effects .


This was a 98-day randomized , double-blind , parallel group , placebo-controlled trial of 57 men , 24-51 year , free T in the lower 25 % of normal range ( < 0.33 nmol/L ) , body mass index 30.0 kg/m ( 2 ) .


Subjects were randomized to one of four groups : ( i ) placebo : gel , pills , and injection ; ( ii ) T/DHT/iE2 : T gel , anastrazole , and acyline ( gonadotropin releasing-hormone antagonist to suppress endogenous T ) ; ( iii ) T/iDHT/E2 : T gel , dutasteride , and acyline ; ( iv ) T/DHT/E2 : T gel , placebo pills , and acyline .


Main outcome measures are insulin sensitivity as percent change ( % ) in glucose disposal rates ( GDR ) from a two-step euglycemic clamp ( GDR1 and 2 ) , and % FM and % FFM by dual X-ray absorptiometry scan .


Insulin Sensitivity : % GDR1 differed across groups ( P = 0.02 , anova ) and was significantly higher in the dutasteride ( T/iDHT/E2 ) compared with the placebo and T gel ( T/DHT/E2 ) groups .


% GDR2 was higher in the dutasteride ( T/iDHT/E2 ) compared with the anastrazole ( T/DHT/iE2 ) group .


Body Composition : T gel alone ( T/DHT/E2 ) or with dutasteride ( T/iDHT/E2 ) significantly increased % FFM ( P < 0.05 ) and decreased % FM ( P < 0.05 ) .


There was no change in % FFM or % FM after placebo or anastrazole ( T/DHT/iE2 ) .


The combination of T plus dutasteride improved body composition and IS while T alone improved body composition but not IS , suggesting that when T is administered to men , reduction to DHT attenuates the beneficial effects of aromatization to E2 on IS but not body composition .


High-dose oestrogen treatment has been used to reduce growth in tall adolescent girls .


The long-term safety with regard to cancer has not been clarified .


Our aim was to study if this growth reduction therapy affects cancer risk later in life .


A cohort study of 369 ( 172 treated , 197 untreated ) Swedish women who in 1973-1993 were assessed for tall adolescent stature was designed .


Data were collected from university hospital records , patient questionnaires , and the Swedish Cancer Register .


Risks are presented as odds ratios ( ORs ) with 95 % confidence intervals comparing treated to untreated subjects .


In treated subjects , the overall OR for having a tumour ( malignant or non-malignant ) was 1.7 ( 0.8-3 .8 ) .


The ORs were 2.3 ( 0.4-12 .8 ) for breast tumours , 0.8 ( 0.2-2 .6 ) for gynaecological tumours , and 6.1 ( 1.04 - ) for melanoma .


When limiting to malignant tumours , the crude ORs were of similar magnitude .


The OR for any melanoma was higher in treated than in untreated women , suggesting an increased risk of melanoma associated with high-dose oestrogen treatment during adolescence .


Although the risk estimates were increased for overall tumours , breast tumours , malignant gynaecological tumours , and malignant melanoma , these associations were not statistically significant .


Our results need to be verified in a larger cohort .


To locate sites of genital tenderness in breast cancer survivors not using estrogen who experience dyspareunia and to test the hypothesis that tenderness is limited to the vulvar vestibule rather than the vagina and is reversed by topical anesthetic .


Postmenopausal survivors of breast cancer with moderate and severe dyspareunia were recruited for an examination including randomization to a double-blind intervention using topical aqueous 4 % lidocaine or normal saline for 3 minutes to the areas found to be tender .


Comparisons of changes in patients ' reported numerical rating scale values were made with the Wilcoxon rank-sum test with significance set at P < .05 .


Forty-nine patients aged 37-69 years ( mean 55.68.6 years ) had a median coital pain score of 8 ( interquartile range 7-9 , scale 0-10 ) .


On examination , all women had tenderness in the vulvar vestibule ( worst site 4 o'clock median 6 , 4-7 ) .


In addition , one had significant vaginal mucosal tenderness and two had pelvic floor myalgia .


All had vulvovaginal atrophy with 86 % having no intravaginal discharge .


Aqueous lidocaine 4 % reduced the vestibular tenderness of all painful sites .


For example , pain at the worst site changed from a median of 5 ( 4-7 ) to 0 ( 0-1 ) as compared with saline placebo , which changed the worst site score from 6 ( 4-7 ) to 4 ( 3-6 ) ( P < .001 ) .


After lidocaine application , speculum placement was nontender in the 47 without either myalgia or vaginal mucosal tenderness .


In breast cancer survivors with dyspareunia , exquisite sensitivity was vestibular and reversible with aqueous lidocaine .


Vaginal tenderness was rare despite severe atrophy .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01539317 .


I.


Panax ginseng and Gingko biloba are commonly used herbal supplements in the United States that have been reported to increase alertness and cognitive function .


The objective of this study was to investigate the effects of these specific herbals on driving performance .


30 volunteers were tested using the STISIM3 Driving Simulator ( Systems Technology Inc. , Hawthorne , CA , USA ) in this double-blind , placebo-controlled study .


The subjects were randomized into 3 groups of 10 subjects per group .


After 10-min of simulated driving , subjects received either ginseng ( 1200 mg ) , Gingko ( 240 mg ) , or placebo administered orally .


The test herbals and placebo were randomized and administered by a research assistant outside of the study to maintain blinding .


One hour following administration of the herbals or placebo , the subjects completed an additional 10-min of simulated driving .


Standard driving parameters were studied including reaction time , standard deviation of lateral positioning , and divided attention .


Data collected for the divided attention parameter included time to response and number of correct responses .


The data was analyzed with repeated-measures analysis of variance ( ANOVA ) and Kruskal-Wallis test using SPSS 22 ( IBM , Armonk , NY , USA ) .


There was no difference in reaction time or standard deviation of lateral positioning for both the ginseng and Ginkgo arms .


For the divided attention parameter , the response time in the Ginkgo arm decreased from 2.9 to 2.5 s.


The ginseng arm also decreased from 3.2 to 2.4 s. None of these values were statistically significant when between group differences were analyzed .


The data suggests there was no statistically significant difference between ginseng , Ginkgo or placebo on driving performance .


We postulate this is due to the relatively small numbers in our study .


Further study with a larger sample size may be needed in order to elucidate more fully the effects of Ginkgo and ginseng on driving ability .


Patient-specific femoral and tibial cutting blocks produced with use of data from preoperative computed tomography ( CT ) or magnetic resonance imaging ( MRI ) scans have been employed recently to optimize component alignment in total knee arthroplasty .


We report the results of a randomized controlled trial in which CT scans were used to compare postoperative component alignment between patients treated with custom instruments and those managed with traditional instruments .


The in-hospital data and early clinical outcomes , including Knee Society scores , were determined in a randomized clinical trial of forty-seven patients who had undergone a total of forty-eight primary total knee arthroplasties with patient-specific instruments ( twenty-two knees ) or standard instruments ( twenty-six knees ) .


Orientation of the implants was compared by using three-dimensional CT data .


No significant differences were found between the study and control groups with respect to any clinical outcome after a minimum of six months of follow-up .


The patient-specific tibial cutting block was abandoned in favor of a standard external alignment jig in seven of the twenty-two study knees because of possible malalignment .


A detailed analysis of intent-to-treat and per-protocol groups of study and control knees did not show any significant improvement in component alignment , including femoral component rotation in the axial plane , in the patients treated with the custom instruments .


The percentage of outliers -- defined as less than -3 or more than 3 from the correct orientation of the tibial slope -- was significantly higher in the group treated with use of patient-specific blocks than it was in the control group , in both the intent-to-treat ( 32 % versus 8 % , p = 0.032 ) and the per-protocol ( 47 % versus 6 % , p = 0.0008 ) analysis .


There were no significant improvements in clinical outcomes or knee component alignment in patients treated with patient-specific cutting blocks as compared with those treated with standard instruments .


The group treated with patient-specific cutting blocks had a significantly higher prevalence of malalignment in terms of tibial component slope than the knees treated with standard instruments .


The quantity of subarachnoid ( SAH ) and intraventricular hemorrhage ( IVH ) occurring in the setting of a ruptured cerebral aneurysm is strongly associated with subsequent complications and poor outcomes .


We randomly allocated aneurysmal SAH patients with a modified Fisher score of 4 , who had been treated with endovascular coil embolization and ventricular drainage , to receive either 2 mg intraventricular tissue plasminogen activator ( TPA ) every 12 h ( maximum 10 mg ) or placebo .


Computed tomography scans were performed 12 , 48 , and 72 h after administration .


Primary outcomes included feasibility ( enrollment and consent rates ) , safety ( assessed by prospectively screening for complications ) , and rate of intracranial blood clearance ( measured using sequential IVH , modified Graeb , and SAH sum scores ) .


Secondary outcomes included angiographic vasospasm , delayed cerebral ischemia , need for ventriculoperitoneal shunting , and 6-month neurological outcomes .


Seventy-seven patients were screened , 17 were eligible , and 12 were randomized .


The consent rate was 87 % .


There were no cases of new intracranial hemorrhage complicating use of TPA .


Models fit using generalized estimating equations demonstrated more rapid reduction in IVH volume ( p = 0.009 ) , modified Graeb score ( p < 0.001 ) , and SAH sum score ( p < 0.001 ) among patients treated with TPA .


SAH clearance at 48 h was enhanced by earlier drug administration ( p = 0.02 ) .


There were no differences in secondary outcomes .


Intraventricular TPA accelerates clearance of SAH and IVH , especially when administered early .


A larger-scale clinical trial of intraventricular TPA is feasible , will need to be conducted at multiple centers , and is required to determine whether this practice reduces complications and improves outcomes .


To compare a sulphonylurea with the glucagon like peptide-1 ( GLP-1 ) receptor agonist liraglutide in combination with metformin in patients on mono/dual oral therapy with established type 2 diabetes fasting during Ramadan .


Ninety-nine adults intending to fast during Ramadan [ 50 % male , mean age 52years , body mass index ( BMI ) 32kg/m ( 2 ) ] were randomized from two UK sites .


Baseline data were collected 14days prior to Ramadan and at 3 and 12weeks after Ramadan .


At 12weeks , more patients in the liraglutide compared with the sulphonylurea group achieved a composite endpoint of haemoglobin A1c ( HbA1c ) < 7 % , no weight gain and no severe hypoglycaemia but this did not reach statistical significance [ odds ratio ( OR ) 4.08 , 95 % confidence interval ( CI ) 0.97 , 17.22 , p = 0.06 ] .


From a baseline of 7.7 % there was no change in HbA1c at 12weeks in the sulphonylurea ( +0.02 % ) compared with a 0.3 % reduction in the liraglutide group ( adjusted coefficient -0.41 , 95 % CI -0.83 , 0.01 , p = 0.05 ) .


Significant reductions were also observed in weight and diastolic blood pressure ( BP ) in the liraglutide compared with the sulphonylurea group .


Treatment satisfaction was comparable across the treatment groups .


There were no episodes of severe hypoglycaemia in either group , however , self-recorded episodes of blood glucose 3.9 mmol/l were significantly lower with liraglutide ( incidence rate ratio 0.29 , 95 % CI 0.19 , 0.41 , p < 0.0001 ) .


Liraglutide compared with sulphonylurea is well tolerated and maybe an effective therapy in combination with metformin during Ramadan with more patients able to achieve target HbA1c , lose or maintain weight with no severe hypoglycaemia .


This was achieved with a high level of treatment satisfaction .


Vulval intraepithelial neoplasia is a skin disorder affecting the vulva that , if left untreated , can become cancerous .


Currently , the standard treatment for patients with vulval intraepithelial neoplasia is surgery , but this approach does not guarantee cure and can be disfiguring , causing physical and psychological problems , particularly in women of reproductive age .


We aimed to assess the activity , safety , and feasibility of two topical treatments -- cidofovir and imiquimod -- as an alternative to surgery in female patients with vulval intraepithelial neoplasia .


We recruited female patients ( age 16 years or older ) from 32 centres to an open-label , randomised , phase 2 trial .


Eligibility criteria were biopsy-proven vulval intraepithelial neoplasia grade 3 and at least one lesion that could be measured accurately .


We randomly allocated patients to topical treatment with either 1 % cidofovir ( supplied as a gel in a 10 g tube , to last 6 weeks ) or 5 % imiquimod ( one 250 mg sachet for every application ) , to be self-applied three times a week for a maximum of 24 weeks .


Randomisation ( 1:1 ) was done by stratified minimisation via a central computerised system , with stratification by hospital , disease focality , and presentation stage .


The primary endpoint was a histologically confirmed complete response at the post-treatment assessment visit 6 weeks after the end of treatment ( a maximum of 30 weeks after treatment started ) .


Analysis of the primary endpoint was by intention to treat .


Secondary outcomes were toxic effects ( to assess safety ) and adherence to treatment ( to assess feasibility ) .


We present results after all patients had reached the primary endpoint assessment point at 6 weeks ; 2-year follow-up of complete responders continues .


This trial is registered with Current Controlled Trials , ISRCTN 34420460 .


Between Oct 21 , 2009 , and Jan 11 , 2013 , 180 participants were enrolled to the study ; 89 patients were randomly allocated cidofovir and 91 were assigned imiquimod .


At the post-treatment assessment visit , a complete response had been achieved by 41 ( 46 % ; 90 % CI 370-553 ) patients allocated cidofovir and by 42 ( 46 % ; 372-553 ) patients assigned imiquimod .


After 6 weeks of treatment , 156 ( 87 % ) patients ( 78 in each group ) had adhered to the treatment regimen .


Five patients in the cidofovir group and seven in the imiquimod group either withdrew or were lost to follow-up before the first 6-week safety assessment .


Adverse events of grade 3 or higher were reported in 31 ( 37 % ) of 84 patients allocated cidofovir and 39 ( 46 % ) of 84 patients assigned imiquimod ; the most frequent grade 3 and 4 events were pain in the vulva , pruritus , fatigue , and headache .


Cidofovir and imiquimod were active , safe , and feasible for treatment of vulval intraepithelial neoplasia and warrant further investigation in a phase 3 setting .


Both drugs are effective alternatives to surgery for female patients with vulval intraepithelial neoplasia after exclusion of occult invasive disease .


Cancer Research UK .


The aim of this study was to determine the relative utility of anatomic and ischemic burden of coronary artery disease for predicting outcomes .


Both anatomic burden and ischemic burden of coronary artery disease determine patient prognosis and influence myocardial revascularization decisions .


When both measures are available , their relative utility for prognostication and management choice is controversial .


A total of 621 patients enrolled in the COURAGE ( Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation ) trial with baseline quantitative nuclear single-photon emission computed tomography ( SPECT ) and quantitative coronary angiography were studied .


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


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


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


There was a marginal ( p = 0.03 ) effect of the interaction term of anatomic and ischemic burden for the prediction of clinical outcome , but separately or in combination , neither anatomy nor ischemia interacted with therapeutic strategy to predict outcome .


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


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


( Clinical Outcomes Utilizing Revascularization and Aggressive Drug Evaluation [ COURAGE ] ; NCT00007657 ) .


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


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


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


Phosphodiesterase-5 inhibitor improves the endothelial function and subsequently microvascular circulation .


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


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


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


A total of 80 patients with proven perfusion defect in adenosine-stress CMR will be randomly assigned to either the udenafil treatment group ( daily dose of 100mg ) or the placebo group for three months .


The primary endpoint is > 25 % improvement in perfusion defect size in adenosine-stress CMR from baseline .


The secondary endpoints include < 25 % improvement in perfusion defect size , chest pain frequency , ST depression in stress test , Duke score in stress test , quality of life ( QoL ) assessment by SF-36 questionnaire , sexual dysfunction assessment by BISF-W ( Brief Index of Sexual Functioning for Women ) self-assessment questionnaire , and biomarkers for endothelial function .


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


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


Clinical Trials.gov : NCT01769482 ( registered on 20 November 2012 ) .


Because human bone marrow ( BM ) CD34 + stem cells home into damaged tissue and may play an important role in tissue repair , this pilot clinical trial explored the safety and feasibility of intravitreal autologous CD34 + BM cells as potential therapy for ischemic or degenerative retinal conditions .


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


CD34 + cells were isolated under Good Manufacturing Practice conditions from the mononuclear cellular fraction of the BM aspirate using a CliniMACs magnetic cell sorter .


After intravitreal CD34 + cell injection , serial ophthalmic examinations , microperimetry/perimetry , fluorescein angiography , electroretinography ( ERG ) , optical coherence tomography ( OCT ) , and adaptive optics OCT were performed during the 6-month follow-up .


A mean of 3.4 million ( range , 1-7 million ) CD34 + cells were isolated and injected per eye .


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


Best-corrected visual acuity and full-field ERG showed no worsening after 6 months .


Clinical examination also showed no worsening during follow-up except among age-related macular degeneration subjects in whom mild progression of geographic atrophy was noted in both the study eye and contralateral eye at 6-month follow-up , concurrent with some possible decline on multifocal ERG and microperimetry .


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


Intravitreal autologous BM CD34 + cell therapy appears feasible and well tolerated in eyes with ischemic or degenerative retinal conditions and merits further exploration .


( ClinicalTrials.gov number , NCT01736059 . )


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


The purpose of this analysis was to characterize clinical outcomes associated with the Mentor MemoryGel ( round ) MemoryShape/Contour Profile Gel ( shaped ) devices through 9 years of use in women undergoing breast augmentation or reconstruction .


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


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


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


Shaped implants were associated with lower cumulative incidence rates of Baker Grade III/IV capsular contracture compared with round implants ( 3.4 % vs 11.3 % , respectively , in primary augmentation , P < 0.0001 ; 15.6 % vs 24.4 % in revision-augmentation , P < 0.05 ) .


Reoperation , explantation , and infection rates were comparable between devices across cohorts , except for lower incidence of infection with shaped than round implants in primary reconstruction ( 1.6 % vs 6.2 % , P < 0.05 ) .


Rupture rates were lower with shaped implants , with significance reached in primary augmentation patients at 8 years ( 3.1 % vs 10.3 % , P < 0.05 ) .


High levels of patient satisfaction ( exceeding 94 % ) with both devices were reported at 9 years across cohorts .


Prospective data through 9 years support comparable safety of round and shaped breast implants , and high levels of patient satisfaction , in patients undergoing primary and revision breast augmentation and reconstruction .


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


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


This study used a randomized experimental design .


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


Descriptive statistics were used to analyze data collected at baseline and 8 weeks .


Twenty-two subjects with SMI ( mean age = 44.09 7.6 years ; 54.5 % were male ) were recruited and 16 subjects completed the study in 8 weeks .


PA ( z = -2.37 , p = .02 ) increased in the treatment group ( n = 8 ) whereas the control group ( n = 8 ) maintained baseline PA level ( z = -1.61 , p = .11 ) .


Health outcomes were not changed ( ps > .05 ) .


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


To observe the myocardial protective effect of electroacupuncture ( EA ) at Neiguan ( PC 6 ) in the patients with valve replacement via extracorporeal circulation .


Fifty patients of rheumatic cardiac disease planned for valve replacement were graded as II or III level according to America Society of Anesthesiologists ( ASA ) and were randomized into an observation group and a control group , 25 cases in each one .


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


In the observation group , 30 min before operation , EA was used to stimulate bilateral Neiguan ( PC 6 ) till the end of operation .


The venous blood was collected at 5 time points separately , named before aorta blockage ( T1 ) , 15 min after aorta open ( T2 ) , 30 min after aorta open ( T3 ) , 6 h after opening ( T4 ) and 24 h after opening ( T5 ) .


The concentrations of malondial dehyde ( MDA ) , superoxide dismutase ( SOD ) and cardiac troponin 1 ( cTnI ) were determined in serum .


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


Compared with those before aorta blockage , MDA and cTnI at each time point of aorta open were all apparently increased in the patients of the two groups ( all P < 0.05 ) , and SOD was reduced apparently ( P < 0.05 ) .


Compared with the control group , at the time points from T3 to T5 , MDA and cTnL were lower apparently in the observation group as compared with those in the control group ( all P < 0.05 ) and SOD was higher than that in the control group ( P < 0.05 ) .


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


05 ) .


EA at Neiguan ( PC 6 ) alleviates oxidative stress injury and has the protective effect on ischemic reperfusion myocardium .


Although gastrointestinal ( GI ) , respiratory , and dermal symptoms are common , few studies have conducted concurrent and comparative prospective analyses of risk factors for these 3 morbidity outcomes .


We used data from a community-based randomized controlled trial among 277 South Australian families to analyze GI ( diarrhea , vomiting ) , respiratory ( sore throat , runny nose , cough ) and dermal ( rash , generalized itch , dermal infection ) symptoms .


Log-binomial regression analysis revealed similar risks of GI ( adjusted risk ratio [ RR ] , 1.65 ; 95 % CI , 1.05-2 .58 ) and respiratory ( RR , 1.68 ; 95 % CI , 1.31-2 .15 ) symptoms among childcare/kindergarten attendees .


Swimming in public pools/spas in the current or previous week was associated with all 3 symptom complexes , conferring similar risk for each ( RR for GI : 1.33 ; 95 % CI , 0.99-1 .77 ; respiratory : 1.20 ; 95 % CI , 1.04-1 .38 ; dermal : 1.41 ; 95 % CI , 1.08-1 .85 ) .


Pet ownership was not associated with symptoms .


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


This simultaneous examination of risk factors for 3 health outcomes yielded new comparative data that are useful for developing prevention strategies .


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


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


We independently analyzed 2 cohorts : ( 1 ) consecutive admissions at the University of Pennsylvania ( Penn ) with a primary discharge diagnosis of heart failure ( n = 657 ) and ( 2 ) patients in the Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness ( ESCAPE ) data set ( n = 390 ) .


DE was estimated as the net fluid output produced per 40 mg of furosemide equivalents , then dichotomized into high versus low DE based on the median value .


There was only a moderate correlation between DE and both intravenous diuretic dose and net fluid output ( r ( 2 ) 0.26 for all comparisons ) , indicating that DE was describing unique information .


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


Low DE was associated with worsened survival even after adjusting for in-hospital diuretic dose , fluid output , in addition to baseline characteristics ( Penn : hazards ratio [ HR ] , 1.36 ; 95 % confidence interval [ CI ] , 1.04-1 .78 ; P = 0.02 ; ESCAPE : HR , 2.86 ; 95 % CI , 1.53-5 .36 ; P = 0.001 ) .


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


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


We investigated this question in a randomized trial .


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


After anesthesia induction and before surgical incision , patients were randomly assigned to remote ischemic preconditioning ( four 5-minute inflations and deflations of a standard blood-pressure cuff on the upper arm ) or sham conditioning ( control group ) .


Anesthetic management and perioperative care were not standardized .


The combined primary end point was death from cardiovascular causes , nonfatal myocardial infarction , coronary revascularization , or stroke , assessed 12 months after randomization .


We enrolled a total of 1612 patients ( 811 in the control group and 801 in the ischemic-preconditioning group ) at 30 cardiac surgery centers in the United Kingdom .


There was no significant difference in the cumulative incidence of the primary end point at 12 months between the patients in the remote ischemic preconditioning group and those in the control group ( 212 patients [ 26.5 % ] and 225 patients [ 27.7 % ] , respectively ; hazard ratio with ischemic preconditioning , 0.95 ; 95 % confidence interval , 0.79 to 1.15 ; P = 0.58 ) .


Furthermore , there were no significant between-group differences in either adverse events or the secondary end points of perioperative myocardial injury ( assessed on the basis of the area under the curve for the high-sensitivity assay of serum troponin T at 72 hours ) , inotrope score ( calculated from the maximum dose of the individual inotropic agents administered in the first 3 days after surgery ) , acute kidney injury , duration of stay in the intensive care unit and hospital , distance on the 6-minute walk test , and quality of life .


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


( Funded by the Efficacy and Mechanism Evaluation Program [ a Medical Research Council and National Institute of Health Research partnership ] and the British Heart Foundation ; ERICCA ClinicalTrials.gov number , NCT01247545 . )


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


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


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


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


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


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


The individual placement and support model of supported employment has been shown to be more effective than other vocational approaches in improving competitive work over 1-2 years in persons with severe mental illness .


The authors evaluated the longer-term effects of the model compared with traditional vocational rehabilitation over 5 years .


A randomized controlled trial compared supported employment to traditional vocational rehabilitation in 100 unemployed persons with severe mental illness .


Competitive work and hospital admissions were tracked for 5 years , and interviews were conducted at 2 and 5 years to assess recovery attitudes and quality of life .


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


The beneficial effects of supported employment on work at 2 years were sustained over the 5-year follow-up period .


Participants in supported employment were more likely to obtain competitive work than those in traditional vocational rehabilitation ( 65 % compared with 33 % ) , worked more hours and weeks , earned more wages , and had longer job tenures .


Reliance on supported employment services for retaining competitive work decreased from 2 years to 5 years for participants in supported employment .


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


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


The results demonstrate that the greater effectiveness of supported employment in improving competitive work outcomes is sustained beyond 2 years and suggest that supported employment programs contribute to reduced hospitalizations and produce a higher social return on investment .


Fructose consumption has risen alongside obesity and diabetes .


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


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


Adolescents were divided into lean ( n = 14 ) , obese insulin sensitive ( n = 12 ) ( OIS ) , and obese insulin resistant ( n = 15 ) ( OIR ) .


In a double-blind , cross-over design , subjects drank 75 g of glucose or fructose in random order , serum was obtained every 10 minutes for 60 minutes .


Baseline acyl-ghrelin was highest in lean and lowest in OIR ( P = 0.02 ) .


After glucose ingestion , acyl-ghrelin decreased similarly in lean and OIS but was lower in OIR ( vs. lean , P = 0.03 ) .


Suppression differences were more pronounced after fructose ( lean vs. OIS , P = 0.008 , lean vs. OIR , P < 0.001 ) .


OIS became significantly hungrier after fructose ( P = 0.015 ) .


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


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


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


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


The protocol was activated in March 2012 as an international multicenter randomized trial in patients with HNSCC .


Tumors were treated to a dose of 66-70Gy , 33-35 fractions , 6 fractions per week .


NIM was administered in a dose of 1.2 gperm ( 2 ) , 90min before the first daily RT fraction .


The primary endpoint was loco-regional failure .


The trial was closed prematurely by June 2014 due to poor recruitment .


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


The trial was dimensioned to include 600 patients in 3years , but only 104 patients were randomized between March 2012 and May 2014 due to the inability to involve three major centers and the insufficient recruitment rate from the other participating centers .


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


Among the remaining 84 patients , 82 patients were evaluable ( 39 and 43 patients in the RT+NIM and the RT-alone arms , respectively ) .


The treatment compliance was good with only six patients not completing the full planned RT course , and 31 patients ( 79 % ) out of 39 allocated for NIM , achieving at least 90 % of the prescribed drug dose .


At the time of evaluation , 40 patients had failed to achieve persistent loco-regional tumor control , and a total of 45 patients had died .


The use of NIM improved the loco-regional tumor control with an 18month post-randomization cumulative failure rate of 33 % versus 51 % in the control arm , yielding a risk difference of 18 % ( CI -3 % to 39 % ; P = 0.10 ) .


The corresponding values for overall death was 43 % versus 62 % , yielding a risk difference of 19 % ( CI -3 % to 42 % ; P = 0.10 ) .


Sixteen patients , out of 55 patients analyzed for hypoxic gene expression , were classified as having more hypoxic tumors .


Such patients , if treated with RT alone , had a higher loco-regional tumor failure rate as compared to the rest of the patients with known hypoxic status ( P = 0.05 ) .


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


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


Pain is highly prevalent among persons with HIV .


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


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


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


Subjects included HIV-infected adults who reported past 6-month risky drinking and unprotected sex and were recruited from HIV and addiction treatment sites in St. Petersburg , Russia .


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


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


General estimating equations ( GEE ) logistic regression models were used to calculate odds ratios and 95 % confidence intervals for the association between pain and risky drinking over time ( i.e. , baseline , 6 and 12 months ) , adjusting for potential confounders .


Baseline characteristics of participants ( n = 699 ) were mean age of 30 ( SD 5 ) years , 41 % female , and 22 % < 9th grade education .


Nearly one quarter ( 24 % ) had a CD4 cell count < 200 cells/l , and only 17 % were on antiretroviral therapy .


Nearly half ( 46 % ) reported at least moderate pain interference in the past month and 81 % were drinking risky amounts .


In adjusted longitudinal GEE models , pain was significantly associated with greater odds of reporting past month risky drinking ( AOR = 1.34 , 95 % CI : 1.05-1 .71 , p value = 0.02 ) .


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


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


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


Recent evidence suggests a role for L-type Ca ( 2 + ) channels in mediating iron uptake by the heart .


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


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


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


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


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


Twenty patients will be randomised in a 1:1 allocation ratio into the intervention and control arms .


In addition to conventional echocardiography , MRI T2 * values for assessment of cardiac and liver iron load will be obtained at baseline and at 6 and 12 months .


Cardiac T2 * will be reported as the geometric mean and per cent coefficient of variation , and an increase in cardiac T2 * values from baseline will be used as an end point to compare the efficacy of therapy .


A p Value of < 0.05 will be considered significant .


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


This study has been approved by the Ethics Review Committee and Clinical Trials Unit at The Aga Khan University with respect to scientific content and compliance with applicable research and human subjects regulations .


Findings will be reported through scientific publications and research conferences and project summary papers for participants .


ClinicalTrials.Gov .


Registration no : NCT02065492 .


The logistic European System for Cardiac Operative Risk Evaluation ( LES ) score and the Society of Thoracic Surgeons ( STS ) score are validated to predict 30-day outcomes following surgical aortic valve replacement ( SAVR ) with or without coronary artery bypass grafting .


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


We compared predicted and observed 30-day/in-hospital and 1-year mortality of patients undergoing TAVR in the first Placement of Aortic Transcatheter Valves trial and continued access registry ( N = 2466 ) .


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


Performance of STS and LES scores among 307 patients undergoing SAVR from the high-risk cohort of the randomized trial were also examined .


In patients undergoing TAVR , the observed 30-day/in-hospital mortality was 6.5 % , whereas the predicted 30-day mortality was higher by both STS score ( 11.4 % 3.9 % ) and LES score ( 26.6 % 16.2 % ) .


The discrimination for both scores was poor for 30-day/in-hospital and 1-year mortality .


Calibration was better for STS score than for LES at 1 year but poor for both at 30 days among TAVR cohort .


These results were consistent among the subgroups of patients undergoing transfemoral and transapical access ; however , the STS score had better performance among the high-risk patients who underwent SAVR at 30 days but not 1 year .


The STS and LES surgical risk scores overestimated 30-day/in-hospital mortality and were poor discriminators of post-TAVR mortality , but the calibration of the STS score was better in these high-risk patients .


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


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


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


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


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


Individuals enrolled in the HomePAP trial ( n = 335 ) .


N/A .


The FOSQ and SAQLI subscores demonstrated high reliability and criterion validity , correlating with Medical Outcomes Study 36-Item Short Form Survey domains .


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


Both the FOSQ and SAQLI scores improved after 3 mo with CPAP therapy .


Averaging 4 h or more of CPAP use was associated with an increase in the FOSQ beyond the minimally important difference .


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


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


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


Portable Monitoring for Diagnosis and Management of Sleep Apnea ( HomePAP ) URL : http://clinicaltrials.gov/show/NCT00642486 .


NIH clinical trials registry number : NCT00642486 .


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


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


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


Patients aged less than 20 years old who had received a diagnosis of epilepsy and suffered from epileptic seizures in 2005 were identified in the NHIRD based on ICD-9-CM and prescription records for the use of at least one AED .


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


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


We also examined the effects of urbanization .


The estimated prevalence of epilepsy was 0.33 % in the pediatric population , with 0.29 % for girls and 0.36 % for boys .


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


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


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


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


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


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


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


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


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


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


This was a randomized , single-blind study .


Hospital patients .


Patients aged 16-60 years with acute pulpitis , acute apical periodontitis , or pericoronitis of the third molar of the mandible experiencing pain 3 on the 11-point numerical pain rating scale .


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


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


One hundred seventy-two dental patients were randomized .


The self-administered method produced significant relief from pain associated with dental diseases ( P0 .001 ) .


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


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


We believe that patients will benefit from this method .


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


A prospective , double-blind , randomized study with 60 ASA grade I-II patients aged 18-65 years awaiting knee arthroscopy under spinal anesthesia .


Patients received 12.5 mg of isobaric bupivacaine or levobupivacaine .


Several features were recorded .


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


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


There were no neuroophthalmological effects in either group .


Sensory ( P = 0.018 ) and motor blockade onset ( P = 0.003 ) was faster in the bupivacaine group .


T6 ( T2-T12 ) and T3 ( T2-T12 ) were the highest sensory block levels for the levobupivacaine and bupivacaine groups , respectively ( P = 0.008 ) .


It took less time to regain maximum motor blockade in the bupivacaine group ( P = 0.014 ) , and the levobupivacaine group required use of analgesia earlier ( P = 0.025 ) .


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


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


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


Droxidopa ( L-threo-3 ,4 - dihydroxyphenylserine ) is an oral norepinephrine prodrug .


Interim analyses of the initial patients enrolled in a multicenter , randomized , double-blind , placebo-controlled phase 3 trial of droxidopa for nOH in PD ( ClinicalTrials.gov Identifier : NCT01176240 ) .


PD patients with documented nOH underwent 2 weeks of double-blind droxidopa or placebo dosage optimization followed by 8 weeks of maintenance treatment ( 100-600 mg t.i.d. ) .


The primary efficacy measure was change in Orthostatic Hypotension Questionnaire ( OHQ ) composite score from baseline to Week 8 .


Key secondary variables included dizziness/lightheadedness score ( OHQ item 1 ) and patient-reported falls .


Among 24 droxidopa and 27 placebo recipients , mean OHQ composite-score change at Week 8 was -2.2 versus -2.1 ( p = 0.98 ) ; in response to this pre-planned futility analysis , the study was temporarily stopped and all data from these patients were considered exploratory .


At Week 1 , mean dizziness/lightheadedness score change favored droxidopa by 1.5 units ( p = 0.24 ) , with subsequent numerical differences favoring droxidopa throughout the observation period , and at Week 1 , mean standing systolic blood-pressure change favored droxidopa by 12.5 mmHg ( p = 0.04 ) .


Compared with placebo , the droxidopa group exhibited an approximately 50 % lower rate of reported falls ( p = 0.16 ) and fall-related injuries ( post-hoc analysis ) .


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


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


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


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


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


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


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


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


Patients allocated to the intensive group will receive an intensive antihypertensive treatment aiming to achieve a target systolic blood pressure of between 120 mmHg and 140 mmHg while the patients in the conservative group will receive conservative antihypertensive treatment as recommended by guidelines for 7 days .


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


Patients will be followed up at 7 days , 30 days , and 90 days .


Primary outcome of this study is the rate of rehemorrhage in 7 days after surgery .


Secondary outcomes include death and dependency at 90 days incidence of ischemic stroke , separate rate of death and dependency at 90 days , health related quality of life ( HRQoL ) at 90 days , incidence of other vascular events , and days of hospitalization .


Dependency is defined by a score of 3-5 based on the modified Rankin Scale ( mRS ) .


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


A5224s was a sub-study of A5202 , a prospective trial of 1857 ART-naive participants randomized to blinded abacavir-lamivudine ( ABC/3TC ) or tenofovir DF-emtricitabine ( TDF/FTC ) with open-label efavirenz ( EFV ) or atazanavir-ritonavir ( ATV/r ) .


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


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


A5224s included 269 participants : 85 % men , 47 % white non-Hispanic , median age 38 years , HIV-1 RNA 4.6 log10 copies/ml , and CD4 cell count 233 cells/l .


Overall , significant gains occurred in weight , BMI , and LBM at 96 weeks post-randomization ( all P < 0.001 ) .


Assignment to ATV/r ( vs. EFV ) resulted in significantly greater weight ( mean difference 3.35 kg ) and BMI gain ( 0.88 kg/m ; both P = 0.02 ) , but not LBM ( 0.67 kg ; P = 0.15 ) , whereas ABC/3TC and TDF/FTC were not significantly different ( P0 .10 ) .


In multivariable analysis , only lower baseline CD4 cell count and higher HIV-1 RNA were associated with greater increase in weight , BMI , or LBM .


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


ABC/3TC vs. TDF/FTC did not differ in change in weight , BMI , or LBM ; ATV/r vs. EFV resulted in greater weight and BMI gain but not LBM .


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


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


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


Localized clear cell renal cell carcinoma patients meeting 1 or both of the following criteria were enrolled in a prospective phase II trial , including radical or partial nephrectomy likely to yield a glomerular filtration rate of less than 30 ml/minute/1 .73 m ( 2 ) , or partial nephrectomy high risk due to high complexity ( R.E.N.A.L. 10 to 12 ) or tumor adjacent to hilar vessels .


Pazopanib ( 800 mg once daily ) was administered for 8 to 16 weeks with repeat imaging at completion of therapy , followed by surgery .


A total of 25 patients enrolled with a median tumor size of 7.3 cm and a median R.E.N.A.L. score of 11 .


Of index lesions 80 % were high complexity and 56 % of patients had a solitary kidney .


Patients received a median of 8 weeks of pazopanib .


The median interval from treatment start to surgery was 10.6 weeks .


R.E.N.A.L. score decreased in 71 % of tumors and 92 % of patients experienced a reduction in tumor volume .


Six of 13 patients for whom partial nephrectomy was not possible at baseline were able to undergo partial nephrectomy after treatment .


The mean parenchymal volume that could be saved with surgery increased from an estimated 107 to 173 cc ( p = 0.0015 ) .


In 5 patients a urine leak developed , which was managed conservatively , and 7 received a transfusion , of whom 1 required embolization .


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


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


Seventy consecutive patients ( 59.216.1 years ; 49 men ; 21 women ) were randomized into two groups and underwent contrast-enhanced chest CT using a 128 section CT scanner .


CT examinations were performed as standard protocol in group A ( n = 35 ) and with the activated novel dose-saving devices , OSDR and ATPS , in group B ( n = 35 ) .


Objective [ signal-to-noise ( SNR ) and contrast-to-noise ratio ( CNR ) ] and subjective image quality ( five-point scale ; 1 = non diagnostic ; 5 = excellent ) as well as radiation dose ( CTDIvol ) were analysed .


CTDIvol of the protocol using OSDR and ATPS was significantly lower than in standard chest CT examinations ( 3.41 versus 6.12.3 mGy ; p < 0.001 ) .


Although the level of noise was slightly elevated in group B ( 14.11.7 versus 11.41.9 HU ; p < 0.01 ) , no significant differences in SNR ( 17.15 versus 16.34.7 ) or subjective image quality ( mean score of 4.6 versus 4.4 ) were observed between both imaging protocols .


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


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


A total of 110 patients were randomly divided into two groups .


One group was administered Met ( n = 55 ) , while the other group underwent LOD ( n = 55 ) .


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


Rates of normal menstruation , ovulation , and pregnancy in the LOD group were higher than in the Met group : 76.4 % ( 42/55 ) vs. 58.2 % ( 32/55 ) , P < 0.04 ; 50.8 % ( 11/258 ) vs. 33.5 % ( 94/281 ) , P < 0.001 ; 38.2 % ( 21/55 ) vs. 20.0 % ( 11/55 ) , P < 0.03 .


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


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


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


Seventy-three individuals with PD and 71 individuals with OP wore a pedometer ( Yamax LS2000 ) and an accelerometer ( ActiGraph GT1M/GT3X + ) simultaneously for one week .


Fifty-one individuals with PD ( 72.6 5.3 years ) and 61 with OP ( 75.6 5.3 years ) provided simultaneously recorded data for 3-7 consecutive days .


Pedometer steps were significantly lower than accelerometer steps in the PD group ( p = .002 ) but not in the OP group ( p = .956 ) .


Bland-Altman plots demonstrated wide limits of agreement between the instruments in both PD ( range = 6,911 steps ) and OP ( range = 6,794 steps ) .


These results suggest that the ActiGraph GT1M/GT3X + should be preferred over the Yamax LS2000 for the assessment of steps in both research and clinical evaluations , particularly in individuals with PD or altered gait .


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


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


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


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


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


Patients with previous ischemic stroke or TIA who had been taking aspirin ( 100mg per day ) , aged 50 years or older , with PAD in the lower limbs based on ankle-brachial index ( ABI ) < 10 will be randomized into the treatment group with cilostazol ( 200mg/day ) or the placebo group on 1:1 basis .


Patients will be evaluated at 1 , 3 , 6 , 9 and 12 months after randomization .


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


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


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


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


Maraviroc , a chemokine co-receptor type 5 ( CCR5 ) antagonist , has demonstrated comparable efficacy and safety to efavirenz , each in combination with zidovudine/lamivudine , over 96 weeks in the Maraviroc vs. Efavirenz Regimens as Initial Therapy ( MERIT ) study .


Here we report 5-year findings .


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


Treatment-naive patients with CCR5-tropic HIV-1 infection ( Trofile ) received maraviroc 300 mg twice daily or efavirenz 600 mg once daily , and zidovudine/lamivudine 300 mg/150 mg twice daily .


After the last patient 's week 96 visit , the study was unblinded and patients could enter a nominal 3-year open-label phase .


Endpoints at the 5-year nominal visit ( week 240 ) included proportion of patients ( CCR5 tropism re-confirmed by enhanced sensitivity Trofile ) with viral load ( plasma HIV-1 RNA ) below 50 and 400 copies/ml , and change from baseline in CD4 ( + ) cell count , as well as safety .


The proportion of patients maintaining viral load below 50 copies/ml was similar between treatment arms throughout the study and at week 240 ( maraviroc 50.8 % vs. efavirenz 45.9 % ) .


Maraviroc-treated patients had a greater increase from baseline in mean CD4 ( + ) cell count than efavirenz-treated patients at week 240 ( 293 vs. 271 cells/l , respectively ) .


Fewer patients on maraviroc vs. efavirenz experienced treatment-related adverse events ( 68.9 vs. 81.7 % ) and discontinued as a result of any adverse event ( 10.6 vs. 21.3 % ) .


Maraviroc maintained similar long-term antiviral efficacy to efavirenz over 5 years in treatment-naive patients with CCR5-tropic HIV-1 .


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


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


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


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


Post-graduate year ( PGY ) 1-3 Emergency Medicine residents were randomized to VL or DL while wearing encapsulating PPE .


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


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


Three time points were utilized in the analysis : Time 0 ( blade at lips ) , Time 1 ( blade removed from lips after endotracheal tube placement ) , and Time 2 ( bag valve mask [ BVM ] attached to endotracheal tube ) .