Patients who underwent LC were randomized to either group IV ( intravenous lidocaine infusion ) , group IP ( intraperitoneal lidocaine administration ) , or group C ( control , IP and IV saline ) .


Outcome measures were total postoperative pain severity ( TPPS ) , total fentanyl consumption ( TFC ) , frequency of administering patient-controlled analgesia ( FPB ) , and a pain control satisfaction score ( PCSS ) .


Significantly reduced TPPS , TFC and FPB scores were observed in groups IP ( n = @ ) and IV ( n = @ ) compared with controls ( n = @ ) .


PCSS was higher in groups IP and IV than in controls .


At @ h postoperation , TPPS was significantly lower in group IP than group IV ; at @-@ h postoperation , FPB was lower in group IP than group IV .


The IP administration of lidocaine and IV lidocaine infusion significantly reduced postoperative pain and opioid consumption in LC patients , compared with control infusions .


For convenience , IV lidocaine could be used for pain reduction following LC ; IP administration places additional burden on the surgeon .


Many countries have over the last few years incorporated mental health assertive interventions in an attempt to address the repercussions of deinstitutionalization .


Recent publications have failed to duplicate the positive outcomes reported initially which has cast doubt on the future of these interventions .


We previously reported on @ patients from a developing country who completed @ months in an assertive intervention which was a modified version of the international assertive community treatment model .


We demonstrated reduction in readmission rates as well as improvements in social functioning compared to patients from the control group .


The obvious question was , however , if these outcomes could be sustained for longer periods of time .


This study aims to determine if modified assertive interventions in an under-resourced setting can successfully maintain reductions in hospitalizations .


Patients suffering from schizophrenia who met a modified version of Weidens ' high frequency criteria were randomized into two groups .


One group received a modified assertive intervention based on the international assertive community treatment model .


The other group received standard care according to the model of service delivery in this region .


Data was collected after @ months , comparing readmissions and days spent in hospital .


The results demonstrated significant differences between the groups .


Patients in the intervention group had significantly less readmissions ( p = @ ) and spent less days in hospital compared to the patients in the control group ( p = @ ) .


Modified assertive interventions may be successful in reducing readmissions and days spent in hospital in developing countries where standard care services are less comprehensive .


These interventions can be tailored in such a way to meet service needs and still remain affordable and feasible within the context of an under-resourced setting .


Bupivacaine is a first choice for regional anesthesia considering its effectiveness , long duration and less motor blockade .


Bupivacaine ( S@-R@ ) is a mixture of optical isomers containing @ % levobupivacaine ( S - ) and @ % dextrobupivacaine ( R + ) created by a Brazilian pharmaceutical company .


This investigation compared cardiac safety and efficacy of bupivacaine S@-R@ with vasoconstrictor and ropivacaine for brachial plexus blockade .


Patients were randomized to receive brachial plexus anesthesia with either bupivacaine S@-R@ with epinephrine @:@,@ ( bupi ) or ropivacaine ( ropi ) , both at @ % , in @ mL solution .


We registered a continuous Holter ECG throughout the procedure , as well as the Lovett scale of force in addition to monitoring ( heart rate , pulse oximetry and non-invasive blood pressure ) .


The incidence of adverse events was compared with the chi-square or Fisher test .


We allocated forty-four patients into two groups .


They did not show any difference related to age , weight or height , gender , as well as for surgical duration .


Supraventricular arrhythmias were not different before or after the plexus blockade , independent of the local anesthetic chosen .


Loss of sensitivity was faster for the bupivacaine group ( @ @ min ) compared to the ropivacaine one ( @ @ min ) , though not significant ( p = @ , Student t ) .


There was a reduction in the cardiac rate , observed during the twenty-four-hour Holter monitoring .


This study showed similar efficacy between bupivacaine S@-R@ for brachial plexus blockade and ropivacaine , with similar incidences of supraventricular arrhythmias .


The purpose of this study was to compare breastfeeding duration in mothers after delivery who were assigned randomly to a behavioral educational intervention vs enhanced usual care .


We conducted a randomized trial .


Self-identified black and Latina mothers early after delivery were assigned randomly to receive a behavioral educational intervention or enhanced usual care .


The @-step intervention aimed to prepare and educate mothers about postpartum symptoms and experiences ( including tips on breastfeeding and breast/nipple pain ) and to bolster social support and self-management skills .


Enhanced usual care participants received a list of community resources and received a @-week control call .


Intention-to-treat analyses examined breastfeeding duration ( measured in weeks ) for up to @ months of observation .


This study was registered with clinicaltrial.gov ( NCT@ ) .


Five hundred forty mothers were assigned randomly to the intervention ( n = @ ) vs control subjects ( n = @ ) .


Mean age was @ years ( range , @-@ years ) ; @ % of the women were Latina , and @ % were black .


Baseline sociodemographic , clinical , psychosocial , and breastfeeding characteristics were similar among intervention vs control subjects .


Mothers in the intervention arm breastfed for a longer duration than did the control subjects ( median , @ vs @ weeks , respectively ; P = @ ) Mothers in the intervention arm were less likely to quit breastfeeding over the first @ months after delivery ( hazard ratio , @ ; @ % confidence interval , @-@ @ ) .


A behavioral educational intervention increased breastfeeding duration among low-income , self-identified black and Latina mothers during the @-month postpartum period .


Providing adequate nutritional support to promote optimal postnatal growth for very low birth weight ( VLBW ) infants has been a difficult problem to surmount in the NICU .


During the past @ decades , improvements in neonatal critical care have made it possible for more VLBW infants to survive to discharge from NICUs .


The NICHD Neonatal Network reported that while intrauterine growth restriction was present in @ % of VLBW infants at birth , @ % demonstrated postnatal growth restriction by @ weeks post menstrual age .


The persistence of this nearly universal growth deficit is associated with the inadequacy of protein and energy intake , which may account for @-@ % of the postnatal growth restriction .


The purpose of this study was to assess whether increasing enteral intake , using supplemental protein , would improve postnatal growth for VLBW infants .


Randomized clinical trial .


Sixty-four infants were enrolled ( @ in control group with @ infants < @ g , and @ in intervention group with @ infants < @ g ) .


There were no sustained statistical differences between weekly measurements of weight , length , head circumference , and skinfold thickness between groups .


There were no significant differences between laboratory results except blood urea nitrogen at time of peak protein intake for intervention group .


Supplemental enteral protein had minimal to no effect on postnatal weight , length , head circumference , body mass , or length of stay .


It may be most important to provide consistent sustained nutritional support with protein from birth to reduce postnatal growth restriction , especially for those infants < @ g at birth .


Radiation absorbed by interventional cardiologists is a frequently under-evaluated important issue .


Aim is to compare radiation dose absorbed by interventional cardiologists during percutaneous coronary procedures for acute coronary syndromes comparing transradial and transfemoral access .


The randomized multicentre MATRIX ( Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX ) trial has been designed to compare the clinical outcome of patients with acute coronary syndromes treated invasively according to the access site ( transfemoral vs. transradial ) and to the anticoagulant therapy ( bivalirudin vs. heparin ) .


Selected experienced interventional cardiologists involved in this study have been equipped with dedicated thermoluminescent dosimeters to evaluate the radiation dose absorbed during transfemoral or right transradial or left transradial access .


For each access we evaluate the radiation dose absorbed at wrist , at thorax and at eye level .


Consequently the operator is equipped with three sets ( transfemoral , right transradial or left transradial access ) of three different dosimeters ( wrist , thorax and eye dosimeter ) .


Primary end-point of the study is the procedural radiation dose absorbed by operators at thorax .


An important secondary end-point is the procedural radiation dose absorbed by operators comparing the right or left radial approach .


Patient randomization is performed according to the MATRIX protocol for the femoral or radial approach .


A further randomization for the radial approach is performed to compare right and left transradial access .


The RAD-MATRIX study will probably consent to clarify the radiation issue for interventional cardiologist comparing transradial and transfemoral access in the setting of acute coronary syndromes .


Gastroesophageal reflux ( GER ) is a frequently occurring condition in infants capable of causing distressing symptoms .


The aim of our study is to evaluate the efficacy of Mg alginate plus simethicone ( Gastrotuss Baby , DMG Italia SRL , Pomezia , Italy ) , compared with rice-starch-thickened formula or with reassurance alone , in the treatment of GER in infants .


The present randomized controlled trial was conducted in full-term infants affected by symptoms suggestive of GER , evaluated through a validated questionnaire ( Infant Gastroesophageal Reflux Questionnaire Revised ) .


The patients were randomized into @ groups according to treatment ( group A : Mg alginate plus simethicone ; group B : thickened formula ; group C : reassurance with lifestyle changes ) .


Evaluation of symptom scores was performed after @ month ( T@ ) and @ months ( T@ ) .


A total of @ ( @ % ) of @ enrolled infants ( median age @ months ; range @-@ ) concluded the study .


After @ month of treatment ( T@ ) , infants treated with Mg alginate plus simethicone showed a statistically significant improvement in symptoms compared with the thickened formula and reassurance ( P < @ , < @ , respectively ) .


At the end of the study , all @ groups of patients showed a significant reduction in symptom scores ( P < @ , < @ , < @ , respectively ) .


Median symptom score values were more significantly reduced in group A than in group B and in group C ( group A vs group B P < @ ; group A vs group C P < @ ; group B vs group C P < @ ) .


Mg alginate plus simethicone seems to be more efficacious on GER symptom scores than thickened formula and reassurance with lifestyle changes alone .


To evaluate the safety and effectiveness of the Trulign toric intraocular lens ( IOL ) in adults with cataract .


Eight private practices in the United States and @ in Canada .


Prospective randomized single-masked multicenter study .


A toric IOL ( @ D , @ D , or @ D , determined by a toric calculator ) was implanted in eligible patients with age-related cataract requiring a @ to @ diopter ( D ) spherical IOL power and with a predicted postoperative astigmatism of @ to @ D. Eyes within the lowest cylinder range ( predicted postoperative astigmatism @ to @ D ) were randomized in a @:@ ratio between the @ D toric IOL group and the nontoric accommodating IOL ( Crystalens ) control group .


The toric @ D group had a statistically significantly greater percentage reduction in absolute cylinder ( P < @ ) and uncorrected distance visual acuity ( P = @ ) than the control group at the @ - to @-day visit .


The mean monocular uncorrected vision at distance , intermediate , and near was @/@ , @/@ , and @/@ , respectively , with the @ D , @ D , and @ D toric IOLs in aggregate ( toric group ) .


In addition , @ % of patients ( @/@ ) had @ degrees or less absolute IOL rotation postoperatively .


Regarding safety , the endpoints for preservation of corrected visual acuity and the incidence of complications and adverse events were met .


The toric IOL was safe and effective in reducing the effects of preoperative corneal astigmatism and provided excellent uncorrected distance and intermediate vision and functional near vision .


The purpose of this study was to investigate the effect of low-level laser therapy ( LLLT ) before and after exercise on quadriceps muscle performance , and to evaluate the changes in serum lactate and creatine kinase ( CK ) levels .


The study was randomized , double blind , and placebo controlled .


A sample of @ healthy volunteers ( male soccer players ) were divided into three groups : placebo , pre-fatigue laser , and post-fatigue laser .


The experiment was performed in two sessions , with a @ week interval between them .


Subjects performed two sessions of stretching followed by blood collection ( measurement of lactate and CK ) at baseline and after fatigue of the quadriceps by leg extension .


LLLT was applied to the femoral quadriceps muscle using an infrared laser device ( @ nm ) , @ cm ( @ ) beam area , six @ mW diodes , energy of @ J per diode ( total energy to each limb @ J ( @ J total ) , energy density @ J/cm ( @ ) , @ W/cm ( @ ) power density , @ sec per leg .


We measured the time to fatigue and number and maximum load ( RM ) of repetitions tolerated .


Number of repetitions and time until fatigue were primary outcomes , secondary outcomes included serum lactate levels ( measured before and @ , @ , and @ min after exercise ) , and CK levels ( measured before and @ min after exercise ) .


The number of repetitions ( p = @ ) , RM ( p = @ ) , and duration of fatigue ( p = @ ) were similar among the groups .


Post-fatigue laser treatment significantly decreased the serum lactate concentration relative to placebo treatment ( p < @ ) and also within the group over time ( after @ min vs. after @ and @ min , p < @ both ) .


The CK level was lower in the post-fatigue laser group ( p < @ ) .


Laser application either before or after fatigue reduced the post-fatigue concentrations of serum lactate and CK .


The results were more pronounced in the post-fatigue laser group .


Liver injury is a serious adverse event leading to permanent discontinuation of lapatinib in affected patients .


This study aimed to validate previously associated major histocompatibility complex ( MHC ) variants as predictors of risk of liver injury by using a large , randomized , placebo-controlled trial of lapatinib in human epidermal growth factor receptor @-positive , early-stage breast cancer ( Tykerb Evaluation After Chemotherapy -LSB- TEACH -RSB- : Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer ) .


The frequency of ALT elevation cases was compared among four MHC variants in @,@ patients randomly assigned to lapatinib .


Cumulative ALT elevation time courses during treatment were also compared between carriers and noncarriers of specified MHC variants .


In lapatinib-treated patients , there was a significant difference in ALT case incidence between HLA carriers and noncarriers .


The highly correlated alleles HLA-DRB@ * @:@ and HLA-DQA@ * @:@ ( study frequency , @ % ) were associated with ALT elevation ( odds ratio , @ ) between cases ( n = @ ) and controls ( n = @,@ ) .


These associations strengthened at higher ALT elevation thresholds and in Hy 's Law cases .


In lapatinib-treated patients , the overall risk for National Cancer Institute-Common Terminology Criteria for Adverse Events grade @ ALT elevation ( > @ upper limit of normal ) was @ % ; HLA allele carriers had an increased risk of @ % ; in noncarriers , risk was reduced to @ % , comparable to ALT elevation for all patients receiving placebo .


The increase in ALT case incidence in the lapatinib arm showed no evidence of plateau during @ year of lapatinib treatment .


These results validate HLA-DRB@ * @:@ allele carriage as a predictor of increased risk of lapatinib-induced liver injury and implicate an immune pathology .


The HLA association could support clinical management of patients experiencing hepatotoxicity during lapatinib treatment .


To explore the safety and efficacy of PRT-@ applied to the outflow vein of a newly created arteriovenous graft ( AVG ) .


Randomized , double-blind , placebo-controlled , single-dose escalation study of PRT-@ ( @ to @ mg ) applied to the graft-vein anastomosis and adjacent outflow vein immediately after AVG placement .


The primary outcome measure was safety .


The efficacy measures were intraoperative increases in outflow vein diameter and blood flow rate , primary unassisted patency , and secondary patency by dose groups ( placebo , low , medium , high and All PRT-@ ) .


A total of @ patients were treated ( @ placebo and @ PRT-@ ) .


There were no significant differences in the proportion of placebo and PRT-@ patients reporting adverse events .


Intraoperative outflow vein diameter increased @ % ( p = @ ) in the placebo group compared with @ % ( p = @ ) , @ % ( p = @ ) and @ % ( p < @ ) , in the low , medium and high groups , respectively .


The comparison between the high and placebo groups was marginally statistically significant ( p = @ ) .


The intraoperative blood flow did not change in the placebo group , and increased in the low , medium and high groups by @ % ( p = @ ) , @ % ( p = @ ) and @ % ( p = @ ) , respectively .


The low group had the longest primary unassisted and secondary patency and the fewest procedures to restore or maintain patency ; however , the differences between groups were not statistically significant .


PRT-@ was well tolerated and increased AVG intraoperative outflow vein diameter and blood flow .


Low dose tended to increase secondary patency and decrease the rate of procedures to restore or maintain patency .


Larger studies with these doses will be necessary to confirm these results .


The blood glucose target range and optimal method to reach this range remain a matter of debate in the intensive care unit ( ICU ) .


A computer decision support system ( CDSS ) might improve the outcome of ICU patients through facilitation of a tighter blood glucose control .


We conducted a multi-center randomized trial in @ French ICU .


Adult patients expected to require treatment in the ICU for at least @ days were randomly assigned without blinding to undergo tight computerized glucose control with the CDSS ( TGC ) or conventional glucose control ( CGC ) , with blood glucose targets of @-@ @ and < @ mmol/L , respectively .


The primary outcome was all-cause death within @ days after ICU admission .


Of the @,@ patients who underwent randomization to the TGC and CGC treatment groups , primary outcome was available for @,@ and @,@ patients , respectively .


The baseline characteristics of these treatment groups were similar in terms of age ( @ @ years ) , SAPS II ( @ @ ) , percentage of surgical admissions ( @ % ) and proportion of diabetic patients ( @ % ) .


A total of @ ( @ % ) patients in the TGC group and @ ( @ % ) in the CGC group had died by day @ ( odds ratio for death in the TGC @ ; @ % confidence interval @-@ @ ; p = @ ) .


Severe hypoglycemia ( < @ mmol/L ) occurred in @ of @,@ patients ( @ % ) in the TGC group and @ of @,@ patients ( @ % ) in the CGC group ( p < @ ) .


Tight computerized glucose control with the CDSS did not significantly change @-day mortality and was associated with more frequent severe hypoglycemia episodes in comparison with conventional glucose control .


We evaluated the effect of ginkgo biloba extract on visual field defect and contrast sensitivity in a Chinese cohort with normal tension glaucoma .


In this prospective , randomized , placebo-controlled crossover study , patients newly diagnosed with normal tension glaucoma , either in a tertiary glaucoma clinic ( n = @ ) or in a cohort undergoing routine general physical examinations in a primary care clinic ( n = @ ) , underwent two @-week phases of treatment , separated by a washout period of @ weeks .


Randomization determined whether ginkgo biloba extract ( @ mg , @ times per day ) or placebo ( identical-appearing tablets ) was received first .


Primary outcomes were change in contrast sensitivity and mean deviation on @-@ SITA standard visual field testing , while secondary outcomes included IOP and self-reported adverse events .


A total of @ patients with mean age @ ( @ ) years were randomized to the ginkgo biloba extract-placebo ( n = @ ) or the placebo-ginkgo biloba extract ( n = @ ) sequence .


A total of @ patients ( @ % , @ in each group ) who completed testing did not differ at baseline in age , sex , visual field mean deviation , contrast sensitivity , IOP , or blood pressure .


Changes in visual field and contrast sensitivity did not differ by treatment received or sequence ( P > @ for all ) .


Power to have detected a difference in mean defect as large as previously reported was @ % .


In contrast to some previous reports , ginkgo biloba extract treatment had no effect on mean defect or contrast sensitivity in this group of normal tension glaucoma patients .


( http://www.chictr.org number , ChiCTR-TRC-@ ) .


In vivo studies showing the effects of biologic healing-promoting factors on tendon-to-bone healing after rotator cuff repair have focused only on biologic healing-promoting factors and have not taken into consideration the effect of the carrier vehicle .


Moreover , most studies have evaluated the healing process using different carrier vehicles , each of which may have specific effects on tendon healing .


This may explain the large variability seen in outcomes in research studies .


In this study , we investigated the effects of Poloxamer @ as a carrier vehicle on rotator cuff healing at the repair site and compared it with those of a collagen sponge , which is a commonly used carrier vehicle .


Fifty-seven adult male Sprague-Dawley rats underwent detachment and immediate repair of the bilateral supraspinatus tendons .


Rats were randomly assigned to three groups : repair only , repair with collagen sponge , and repair with Poloxamer @ .


The repairs were evaluated at @ , @ , @ , and @ weeks after surgery with histological analysis and biomechanical testing .


At @ weeks , more cellular organization , a greater number of collagen fibers , and increased maturity of collagen fibers were observed in the repair with Poloxamer @ group than in the other groups .


The repair with collagen sponge group had delayed development and collagen fiber maturation .


Significant differences in the biomechanical properties were found between groups at @ weeks .


Stiffness in the case of the repair with Poloxamer @ group was significantly higher than that in the repair with collagen sponge group .


The modulus was significantly lower in the repair with collagen sponge group than in the repair only group .


However , the use of Poloxamer @ versus the collagen sponge did not significantly affect the biomechanical properties of the repaired tendons at @ weeks .


Carrier vehicles may have differing effects at the early stages of rotator cuff healing .


The use of Poloxamer @ as a carrier vehicle may be useful for promoting the early stages of healing and for maintaining the initial biomechanical properties of the repaired rotator cuff tendon .


Low vitamin D serum levels have been associated with unfavourable lipid profile and poorer response to atorvastatin .


Aims of this study were to test the effects of @-hydroxyvitamin D@ ( calcifediol ) compared to parental vitamin D@ ( cholecalciferol ) supplementation on modifications of plasma @ ( OH ) D levels and lipid profile .


Fifty-seven postmenopausal women ( aged @ @ years ) who were at low risk of fracture and with basal plasma @ ( OH ) D < @ ng/mL were included if they were on atorvastatin treatment prescribed as appropriate .


Recruited women were randomized to receive oral calcifediol or cholecalciferol , both at a dose of @ g according to a weekly regimen .


At baseline , @ ( OH ) D was negatively associated with BMI ( r = -@ ; P = @ ) , total cholesterol ( r = -@ ; P = @ ) and LDL-C ( r = -@ ; P = @ ) .


After @ weeks , @ ( OH ) D increased significantly in both groups ( P < @ ) , although higher levels were obtained with calcifediol as compared with cholecalciferol ( P < @ ) .


Only in the calcifediol group , a significant reduction of LDL-C ( P = @ ) and an increase of HDL-C ( P = @ ) were obtained , even after adjustment for age , and baseline BMI , @ ( OH ) D and lipid levels ( P < @ ) .


The percentage changes in @ ( OH ) D levels were associated with the variations of LDL-C ( r = -@ ; P = @ ) and HDL-C levels ( r = @ ; P = @ ) .


Calcifediol administration in osteopenic and dyslipidemic postmenopausal women with low @ ( OH ) D improves lipid profile when added to an ongoing atorvastatin treatment .


It is believed that gastric pH interferes in levothyroxine absorption .


Omeprazole , which acts by blocking the secretion of gastric acid , might interfere in hypothyroidism control in patients using levothyroxine and this effect could be dose dependent .


The present study aimed to investigate this possibility .


Twenty-one patients with primary hypothyroidism who had been using a stabilized levothyroxine dosage for at least one year were selected and randomly assigned to take omeprazole at the dosage of @ mg or @ mg per day .


The mean levels of thyroid-stimulating hormone ( TSH ) before and @ months after omeprazole usage were compared in the entire sample and in each group .


Ten patients concluded the entire treatment protocol in the @ mg group and nine patients in the @ mg group .


There was no significant difference in TSH levels before and @ months after omeprazole treatment in the entire patient sample ( median levels : @ vs. @ mU/L , respectively : p = @ ) .


Analysis of each subgroup ( @ and @ mg ) showed no significant variation in TSH levels before and @ months after omeprazole treatment ( median levels : @ vs. @ mU/L , p = @ , and @ vs. @ mU/L , p = @ , respectively ) .


No significant difference in the absolute ( p = @ ) or relative ( p = @ ) delta were observed between the two subgroups .


Omeprazole in the dosage of @ or @ mg/day does not interfere in a clinically relevant manner in the treatment of patients with hypothyroidism that was previously under control .


To compare the @-month results of accelerated and standard collagen crosslinking ( CXL ) treatment of progressive keratoconus .


Noor Eye Hospital , Tehran , Iran .


Prospective randomized clinical trial .


Two groups of eyes ( intervention and control ) received corneal collagen crosslinking ( CXL ) treatment .


The intervention group received accelerated CXL ( @ mW/cm ( @ ) , @ minutes ) , and the control group received standard CXL ( @ mW/cm ( @ ) , @ minutes ) .


The eyes were evaluated for changes in the visual indices , refraction , and topography preoperatively and @ , @ , and @ months postoperatively and regarding corneal rigidity indices and the endothelial cell count ( ECC ) preoperatively and at @ months .


The study evaluated @ eyes ( @ patient ) in @ groups .


The mean changes in uncorrected ( P = @ ) and corrected ( P = @ ) distance visual acuities and manifest refraction spherical equivalent ( P = @ ) did not differ statistically significantly between the @ groups .


The central corneal thickness was higher in the standard group than the accelerated group ( P = @ ) .


The mean decrease in the maximum keratometry ( K ) ( P = @ ) and mean K ( P = @ ) and the mean changes in the asphericity ( P = @ ) were not statistically significantly different between the @ groups .


The mean changes in corneal hysteresis ( CH ) ( P = @ ) and the corneal resistance factor ( CRF ) ( P = @ ) , CH-CRF ( P = @ ) , and the area under the peak @ ( P = @ ) were similar in both groups .


The mean decrease in the ECC was not statistically significantly different between the @ groups ( P = @ ) .


Based on @-month results , accelerated and standard corneal CXL arrested the progression of keratoconus similarly .


Assess the efficacy and safety of etoricoxib @mg compared with ibuprofen @mg qid in the treatment of moderate to severe primary dysmenorrhea in Chinese women .


This multicenter , double-blind , two-period , cross-over study randomized healthy , Chinese women @ years of age to etoricoxib @mg qd or ibuprofen up to @mg ( @mg qid ) upon onset of moderate or severe primary dysmenorrhea symptoms during two menstrual cycles .


The primary efficacy endpoint was Total Pain Relief score over the first @ hours ( TOPAR@ ) .


Secondary endpoints included Sum of Pain Intensity Difference scores over the first @ hours ( SPID@ ) and Patient 's Global Evaluation ( GLOBAL ) of pain at @ and @ hours post initial dose .


The primary hypothesis was that etoricoxib would be non-inferior to ibuprofen .


Adverse experiences ( AE ) were monitored and evaluated .


A total of @ patients were included in this study .


Difference in least squares ( LS ) mean ( @ % CI ) TOPAR@ score for etoricoxib vs. ibuprofen was @ ( @ , @ ) ( p = @ ) .


LS mean ( @ % CI ) difference for etoricoxib vs. ibuprofen SPID@ , GLOBAL@ , and GLOBAL@ were @ ( -@ , @ ) ( p = @ ) , @ ( @ , @ ) ( p = @ ) , and @ ( @ , @ ) ( p < @ ) , respectively .


AEs were rare , with the following AEs determined to be drug-related : hypomenorrhea ( two patients on etoricoxib ) and allergic dermatitis ( one patient on ibuprofen ) .


Limitations of the study design include a sample size that is not adequate for evaluation of rare adverse effects , an evaluation period that was limited to @ hours , and inconsistent frequency of active treatment doses between etoricoxib ( once daily ) and ibuprofen ( up to four times daily ) .


The primary objective of the study was met , demonstrating that etoricoxib @mg qd was non-inferior to ibuprofen @mg qid ; further , etoricoxib was statistically superior to ibuprofen @mg qid according to the primary endpoint ( TOPAR@ ) and patient global assessments of study medication .


Etoricoxib and ibuprofen were generally well tolerated .


The purpose of the study is to evaluate the effects of creatine supplementation on homocysteine ( Hcy ) plasma levels after acute exercise in humans .


Twenty-three young ( under-@ ) soccer players were divided into @ groups : creatine ( Cr ) - and placebo ( Pla ) - supplemented groups .


The supplementation was performed in double-blind controlled manner using creatine or placebo tablets with @ g/kg during @ days .


Before and after @ days of supplementation , the athletes performed an acute high-intensity sprint exercise ( two consecutive running-based anaerobic sprint test protocol consisted in @ @ m sprint with @ s between them ) .


Blood samples were collected before and after @ days of supplementation as well as @ and @ h after exercise protocol .


Homocysteine concentration significant increased ( P < @ ) @ h after acute exercise ( @ % ) .


Acute exercise also decreased red blood cell S-adenosylmethionine ( SAM ) @ % with no changes in SAM/SAH ratio .


Seven days of creatine supplementation were able to increase ( P < @ ) plasma creatine concentration ( Pla @ @ vs Cr @,@ @ mol/L ) as well as decrease ( P < @ ) plasma guanidinoacetic acid ( @ % ) .


Controversially , creatine supplementation did not change Hcy plasma level after @-day supplementation ( Pla @ @ vs Cr @ @ mol/L ) or after acute exercise ( Pla @ @ vs Cr @ @ mol/L ) .


No changes in plasma vitamin B@ and folate as well as cysteine and methionine were found .


Seven days of creatine supplementation does not avoid increased plasma Hcy induced by acute sprint exercise in humans .


To evaluate the clinical efficacy of asthma at acute attack stage treated with `` Shao 's five needling therapy '' .


The randomized controlled method was applied to divide @ cases into an observation group and a control group , @ cases in each one .


In the observation group , `` Shao 's five needling therapy '' -LSB- Feishu ( BL @ ) , Dazhui ( GV @ ) , Fengmen ( BL @ ) -RSB- and the combined therapy were adopted , including oxygen uptake , aerosol inhalation and oral administration of prednisone .


In the control group , the oral administration of theophylline sustained release tablet and the combined therapy were applied .


The treatment was continued for @ days .


The clinical symptoms and physical signs such as wheezing , cough , expectoration , chest stuffiness , wheezing rale and shortness of breath , as well as lung function indices such as forced expiratory volume one second ( FEV@ ) and peak expiratory flow ( PEF ) were observed before and after treatment in the two groups .


In the observation group , @ cases were cured clinically , @ cases effective remarkably , @ cases effective and @ case failed .


In the control group , @ cases were cured clinically , @ cases effective remarkably , @ cases effective and @ case failed .


The difference in the efficacy was significant in comparison of the two groups ( P < @ ) .


The therapeutic effect in the observation group was better than that in the control group .


The total score of the symptoms and physical signs , FEV@ and PEF after treatment were all improved significantly in the two groups ( all P < @ ) .


And the results in the observation group were better than those in the control group ( all P < @ ) .


`` Shao 's five needling therapy '' achieves the significant efficacy on asthma at acute attack stage .


It significantly relieves the symptoms and physical signs of the patients and improves lung functions .


The effect is better than that of theophylline sustained release tablet .


In a double-blind , randomized , placebo-controlled birth cohort , we have recently shown a beneficial effect of Lactobacillus rhamnosus HN@ ( HN@ ) for the prevention of eczema in children through to @years of age but no effect of Bifidobacterium animalis subsp lactis HN@ ( HN@ ) .


Among this cohort of children , we aim to investigate whether these probiotics could modify the expression of genetic predisposition to eczema conferred by genetic variation in susceptibility genes .


Thirty-three eczema susceptibility SNPs ( in eleven genes ) were genotyped in @ children of European ancestry .


Children who carried a genetic variant that put them at a high risk of developing eczema were less likely to develop eczema if they had been randomized to the HN@ intervention group compared to those in the placebo group .


HN@ was also able to protect against the effects of some SNPs .


As well as modifying genetic susceptibility to childhood eczema , HN@ was also found to modify genetic susceptibility to eczema severity and atopy risk .


This is the first study to show an effect of a probiotic on reducing eczema risk amongst those with particular eczema-associated genotypes .


Our findings suggest that Lactobacillus rhamnosus HN@ may be particularly effective in preventing eczema in children with specific high-risk genotypes .


The aim of this cadaveric study was to compare a polyaxial ( NCB , Zimmer ) to a fixed-angle monoaxial locking plate ( PERILOC , Smith & Nephew ) in comminuted fractures of the distal femur regarding stability of the construct .


Up to date there is no published biomechanical data concerning polyaxial plating in cadaveric distal femurs .


Fourteen formalin fixed femora were scanned by dual-energy x-ray absorptiometry .


As fracture model an unstable supracondylar comminuted fracture was simulated .


Fractures were pairwise randomly fixed either with a mono - ( group A ) or a polyaxial ( group B ) distal femur plate .


The samples were tested in a servohydraulic mechanical testing system starting with an axial loading of @ N following an increase of @ N in every step with @ cycles in every sequence up to a maximum of @ @ N.


The end points were implant failure or relevant loss of reduction .


Data records included for each specimen time , number of cycles , axial load and axial displacement .


Statistical analysis was performed using the exact Wilcoxon signed rank test .


The mean donor age at the time of death was @ years .


The bone mass density ( BMD ) of the femurs in both groups was comparable and showed no statistically significant differences .


Five bones failed before reaching the maximum applied force of @ N. Distribution curves of all samples in both groups , showing the plastic deformation in relation to the axial force , showed no statistically significant differences .


Operative stabilization of distal femur fractures can be successfully and equally well achieved using either a monoaxial or a polyaxial locking plate .


Polyaxial screw fixation may have advantages if intramedullary implants are present .


The international standard of care for women with suspected advanced ovarian cancer is surgical debulking followed by platinum-based chemotherapy .


We aimed to establish whether use of platinum-based primary chemotherapy followed by delayed surgery was an effective and safe alternative treatment regimen .


In this phase @ , non-inferiority , randomised , controlled trial ( CHORUS ) undertaken in @ hospitals in the UK and New Zealand , we enrolled women with suspected stage III or IV ovarian cancer .


We randomly assigned women ( @:@ ) either to undergo primary surgery followed by six cycles of chemotherapy , or to three cycles of primary chemotherapy , then surgery , followed by three more cycles of completion chemotherapy .


Each @-week cycle consisted of carboplatin AUC@ or AUC@ plus paclitaxel @ mg/m ( @ ) , or an alternative carboplatin combination regimen , or carboplatin monotherapy .


We did the random assignment by use of a minimisation method with a random element , and stratified participants according to the randomising centre , largest radiological tumour size , clinical stage , and prespecified chemotherapy regimen .


Patients and investigators were not masked to group assignment .


The primary outcome measure was overall survival .


Primary analyses were done in the intention-to-treat population .


To establish non-inferiority , the upper bound of a one-sided @ % CI for the hazard ratio ( HR ) had to be less than @ .


This trial is registered , number ISRCTN@ , and is closed to new participants .


Between March @ , @ , and Aug @ , @ , we randomly assigned @ women to treatment .


Of the @ women who were eligible , @ were assigned to primary surgery and @ to primary chemotherapy .


All were included in the intention-to-treat analysis ; @ assigned to primary surgery and @ to primary chemotherapy were included in the per-protocol analysis .


As of May @ , @ , @ deaths had occurred : @ in the primary-surgery group versus @ in the primary-chemotherapy group .


Median overall survival was @ months in the primary-surgery group versus @ months in primary chemotherapy .


The HR for death was @ in favour of primary chemotherapy , with the upper bound of the one-sided @ % CI @ ( @ % CI @-@ @ ) .


Grade @ or @ postoperative adverse events and deaths within @ days after surgery were more common in the primary-surgery group than in the primary-chemotherapy group ( @ -LSB- @ % -RSB- of @ women vs @ -LSB- @ % -RSB- of @ , p = @ , and @ women -LSB- @ % -RSB- vs @ woman -LSB- < @ % -RSB- , p = @ ) .


The most common grade @ or @ postoperative adverse event was haemorrhage in both groups ( @ women -LSB- @ % -RSB- in the primary-surgery group vs @ -LSB- @ % -RSB- in the primary-chemotherapy group ) .


@ ( @ % ) of @ women receiving primary surgery and @ ( @ % ) of @ receiving primary chemotherapy had a grade @ or @ chemotherapy related toxic effect ( p = @ ) , mostly uncomplicated neutropenia ( @ % and @ % , respectively ) .


One fatal toxic effect , neutropenic sepsis , occurred in the primary-chemotherapy group .


In women with stage III or IV ovarian cancer , survival with primary chemotherapy is non-inferior to primary surgery .


In this study population , giving primary chemotherapy before surgery is an acceptable standard of care for women with advanced ovarian cancer .


Bone metastases from renal cell carcinoma ( RCC ) are a major cause of morbidity .


Post hoc analysis has suggested that bone turnover markers can identify patients at risk of skeletal-related events ( SREs ) among those receiving zoledronic acid .


This study sought to evaluate the effect on bone metastases of everolimus alone compared with everolimus plus zoledronic acid .


Thirty treatment-naive patients with RCC and @ bone metastases were randomized @:@ to everolimus ( @ mg daily ) versus everolimus plus zoledronic acid ( @ mg intravenously @-weekly ) .


Bone-specific assessments were performed at baseline and at weeks @ , @ , @ , and @ .


Treatment was continued on allocated arm until progression per RECIST @ ( Response Evaluation Criteria in Solid Tumors , version @ ) .


The primary outcome measure was urine N-telopeptide ( uNTX ) level , with secondary measures of plasma C-telopeptide ( CTX ) , quality of life ( Functional Assessment of Cancer Therapy-Bone Pain -LSB- FACT-BP -RSB- , Brief Pain Inventory -LSB- BPI -RSB- ) , progression-free survival ( PFS ) , SREs , and safety .


After @ weeks , reduction in mean uNTX and CTX on everolimus plus zoledronic acid relative to everolimus was @ % ( @ % CI , @ % -@ % ; P < @ ) and @ % ( @ % CI , @ % -@ % ; P < @ ) , respectively .


There was no evidence of a difference for FACT-BP ( P = @ ) , but evidence was favorable for BPI Severity ( P = @ ) and BPI Interference ( P = @ ) .


Median PFS was @ months ( @ % CI , @-@ @ ) on everolimus plus zoledronic acid and @ months ( @ % CI , @-@ @ ) on everolimus ( P = @ ) .


Median time to first SRE was @ months ( @ % CI , @-@ @ ) on everolimus plus zoledronic acid and @ months ( @ % CI , @-@ @ ) on everolimus ( P = @ ) .


In this RCC population , the addition of zoledronic acid to everolimus significantly reduced bone resorption markers and may prolong tumor control .


Induced hypotension is widely used intraoperatively to reduce blood loss and to improve the surgical field during spinal surgery .


To determine the effect of milrinone on induced hypotension during spinal surgery in elderly patients .


Prospective randomized clinical trial .


Forty patients , @ to @ years old , ASA I-II , who underwent elective lumbar fusion surgery .


Intraoperative hemodynamics , blood loss , hourly urine output , and grade of surgical field .


All patients were randomized to group M or N.


The study drug was infused after perivertebral muscle retraction until complete interbody fusion .


In group M , @ g/kg/min of milrinone was infused over @ minutes as a loading dose followed by @ g/kg/min of milrinone as a continuous dose .


In group N , an identical volume of normal saline was infused in the same fashion .


This study was not funded by commercial or other sponsorship and the authors confirm no conflicts of interest , financial or otherwise .


During infusion of the study drug , the systolic and mean blood pressures were maintained within adequate limits of induced hypotension in group M. Intraoperative blood loss was @ mL in group M and @ mL in group N ( p = @ ) .


Hourly urine output was @ mL in group M and @ mL in group N ( p < @ ) .


The grade of the surgical field was better in group M than in group N ( p = @ ) .


We conclude that milrinone is useful for induced hypotension in elderly patients during spinal surgery .


The aim of this study was to determine whether providing information about the lifestyle changes required for an individual to lose weight following bariatric surgery would mitigate the negative judgments of that individual .


In an experimental design , participants provided their initial impressions of a woman with obesity before learning that she had lost a significant amount of weight through : ( @ ) diet/exercise , ( @ ) surgery , or ( @ ) surgery + diet/exercise .


Participants then provided their impressions of the woman after she had lost weight .


For ratings of laziness , competence , and responsibility for weight loss , the individual who lost weight through surgery was rated most negatively , followed by the individual who lost weight through surgery + diet/exercise , with the individual who lost weight through diet/exercise alone rated as least lazy , most competent , and most responsible for her weight loss .


Mediation analyses further showed that group differences in target ratings of laziness/competence were due to perceptions of responsibility for weight loss .


Providing information about the lifestyle changes required for losing weight following bariatric surgery can somewhat dampen the negative evaluations of surgery patients .


These findings also highlight the importance of perceived effort in judgments of individuals with obesity .


We hypothesized that the Laryngoscope with Fiber Optic Reusable Flexible Tip English Macintosh blade ( TMAC ) is beneficial for the intubation of child manikins while performing cardiopulmonary resuscitation ( CPR ) .


In the present study , we evaluated the effectiveness of the conventional Macintosh laryngoscope ( MAC ) and TMAC in @ simulated CPR scenarios .


A randomized crossover simulation trial was designed .


One hundred seven paramedics intubated the trachea of a PediaSIM CPR training manikin ( FCAE HealthCare , Sarasota , FL ) using the MAC and TMAC in a normal airway scenario ( scenario A ) , normal airway with chest compression scenario ( scenario B ) , and difficult airway with chest compression scenario ( scenario C ) .


The participants were directed to make a maximum of @ attempts in each scenario .


The success rate , time required for intubation , Cormack-Lehane grade , dental compression , and the ease of intubation were measured .


The median time of intubation with MAC and TMAC in scenario A was @ ( interquartile range -LSB- IQR -RSB- , @-@ ) vs @ ( IQR , @-@ @ ) ; in scenario B , @ ( IQR , @-@ ) vs @ ( IQR , @-@ ) seconds ; and in scenario C , @ ( IQR , @-@ ) vs @ ( IQR , @-@ ) seconds , respectively .


The overall efficacy for each of the scenarios was as follows : in scenario A , it was @ % vs @ % ; in scenario B , it was @ % vs @ % ( P = @ ) ; and in scenario C , it was @ % vs @ % ( P < @ ) , respectively .


The TMAC seems to be a superior intubating device compared with the conventional MAC when used in simulated normal and difficult child airway with chest compression scenarios .


Future studies should explore the efficacy of TMAC in pediatric clinical emergency settings .


The aim of the study was to assess the safety and efficacy of high - and low-dose oral , delayed-release mesalamine in a randomized , double-blind , active control study of children with mild-to-moderately active ulcerative colitis .


Patients ages @ to @ years , with a Pediatric Ulcerative Colitis Activity Index ( PUCAI ) score of @ to @ and a truncated Mayo Score of @ for both rectal bleeding and stool frequency , were enrolled .


They received body weight-dependent doses of oral , delayed-release mesalamine for @ weeks in a low - ( @-@ mg g ( -@ ) day ( -@ ) ) or high-dose group ( @-@ mg g ( -@ ) day ( -@ ) ) .


The primary endpoint was treatment success , defined as the proportion of patients who achieved remission ( PUCAI score < @ ) or partial response ( PUCAI score @ with a decrease from baseline by @ points ) .


Secondary endpoints included truncated Mayo Score and global assessment of change of disease activity .


The modified intent-to-treat population included @ of @ patients enrolled .


Treatment success by PUCAI was achieved by @ of @ ( @ % ) and @ of @ ( @ % ) patients in the mesalamine low - and high-dose groups , respectively ( P = @ ) .


Truncated Mayo Score ( low-dose @ -LSB- @ % -RSB- and high-dose @ -LSB- @ % -RSB- patients ) and other efficacy results did not differ between the groups .


The type and severity of adverse events were consistent with those reported in previous studies of adults with ulcerative colitis and did not differ between groups .


Both low - and high-dose oral , delayed-release mesalamine doses were equally effective as short-term treatment of mild-to-moderately active ulcerative colitis in children , without a specific benefit or risk to using either dose .


The p@ MAPK pathway seems to be involved in pathogenesis of chronic obstructive pulmonary disease ( COPD ) .


Losmapimod is a potent and selective inhibitor of p@ MAPK .


We assessed the effect of losmapimod on exercise tolerance in patients with COPD .


We did this randomised , parallel-group , placebo-controlled trial at @ secondary care centres in Argentina , Czech Republic , Estonia , Germany , Norway , South Korea , Ukraine , and USA between Nov @ , @ , and Dec @ , @ .


We enrolled patients aged @ years or older with moderate-to-severe COPD ( @ min walking distance < @ m ) who were current or previous smokers .


Patients were randomly assigned ( @:@:@:@ ) by a computer generated sequence to one of losmapimod @ mg , @ mg , or @ mg , or placebo , twice daily for @ weeks .


Randomisation was stratified by country and exacerbation history ( block size eight ) .


Patients and investigators were masked to treatment assignment .


The primary outcome was change in @ min walking distance between baseline and week @ , assessed in the intention-to-treat population .


This study is registered with ClinicalTrial.gov , number NCT@ .


We screened @ patients , of whom @ were enrolled and received treatment .


The difference between the placebo group and the losmapimod groups for mean change of @ min walk distance was not significant : -@ m ( @ % CI -@ to @ ) for losmapimod @ mg , -@ m ( -@ to @ ) for losmapimod @ mg , and -@ m ( -@ to @ ) for losmapimod @ mg .


The safety profile was much the same in each group , although drug-related adverse events were more common with losmapimod @ mg ( n = @ , @ % ) and losmapimod @ mg ( n = @ , @ % ) than with placebo ( n = @ , @ % ) and losmapimod @ mg ( n = @ , @ % ) .


The most common serious adverse events were COPD exacerbation resulting in admission to hospital ( eight patients -LSB- @ % -RSB- taking placebo , six -LSB- @ % -RSB- taking losmapimod @ mg , two -LSB- @ % -RSB- taking losmapimod @ mg , and three -LSB- @ % -RSB- taking losmapimod @ mg ) and pneumonia ( four -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Losmapimod did not cause an improvement in exercise tolerance or lung function , despite being well-tolerated in this COPD population .


Despite antirestenotic efficacy of coronary drug-eluting stents ( DES ) compared with bare metal stents ( BMS ) , the relative risk of stent thrombosis and adverse cardiovascular events is unclear .


Although dual antiplatelet therapy ( DAPT ) beyond @ year provides ischemic event protection after DES , ischemic event risk is perceived to be less after BMS , and the appropriate duration of DAPT after BMS is unknown .


To compare ( @ ) rates of stent thrombosis and major adverse cardiac and cerebrovascular events ( MACCE ; composite of death , myocardial infarction , or stroke ) after @ vs @ months of thienopyridine in patients treated with BMS taking aspirin and ( @ ) treatment duration effect within the combined cohorts of randomized patients treated with DES or BMS as prespecified secondary analyses .


International , multicenter , randomized , double-blinded , placebo-controlled trial comparing extended ( @-months ) thienopyridine vs placebo in patients taking aspirin who completed @ months of DAPT without bleeding or ischemic events after receiving stents .


The study was initiated in August @ with the last follow-up visit in May @ .


Continued thienopyridine or placebo at months @ through @ after stent placement , in @,@ randomized patients treated with aspirin , of whom @ received BMS and @ DES .


Stent thrombosis , MACCE , and moderate or severe bleeding .


Among @ patients treated with BMS who were randomized to continued thienopyridine vs placebo , rates of stent thrombosis were @ % vs @ % ( n = @ vs @ ; hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @-@ @ ; P = @ ) , rates of MACCE were @ % vs @ % ( n = @ vs @ ; HR , @ ; @ % CI , @-@ @ ; P = @ ) , and rates of moderate/severe bleeding were @ % vs @ % ( n = @ vs @ ; P = @ ) , respectively .


Among all @,@ randomized patients ( both BMS and DES ) , stent thrombosis rates were @ % vs @ % ( n = @ vs @ ; HR , @ ; @ % CI , @-@ @ ; P < @ ) , rates of MACCE were @ % vs @ % ( n = @ vs @ ; HR , @ ; @ % CI , @-@ @ ; P < @ ) , and rates of moderate/severe bleeding were @ % vs @ % ( n = @ vs @ ; P < @ ) .


Among patients undergoing coronary stent placement with BMS and who tolerated @ months of thienopyridine , continuing thienopyridine for an additional @ months compared with placebo did not result in statistically significant differences in rates of stent thrombosis , MACCE , or moderate or severe bleeding .


However , the BMS subset may have been underpowered to identify such differences , and further trials are suggested .


To evaluate the effectiveness of low-intensity pulsed ultrasound ( LIPUS ) for the improvement of lower limb bone stress injuries in a civilian population .


A prospective , randomized , double-blinded , placebo-controlled trial to compare LIPUS with placebo .


Civilian private practice population in Sydney , Australia .


Subjects were recruited if a grade II-IV bone stress injury was diagnosed on magnetic resonance imaging ( MRI ) of either the postero-medial tibia , fibula or second , third , or fourth metatarsal .


Subjects of all levels of sporting activity were included .


Thirty subjects were initially recruited , and @ subjects were included in the final analysis .


Subjects were randomized into either the treatment or placebo arm and matched to the site of injury ( tibia , fibula , or metatarsal ) .


Subjects in both arms used either treatment or placebo devices for @ minutes daily for @ weeks .


Six clinical parameters ( night pain , pain at rest , pain on walking , pain with running , tenderness , and pain with single leg hop ) were compared before and after intervention .


The changes in MRI grade and bone marrow edema size were also compared .


There were no significant differences between the treatment and placebo conditions for changes in MRI grading ( @ vs @ , P = @ ) or bone marrow edema size ( @ vs @ , P = @ ) .


There were no significant differences between the treatment and placebo conditions for the @ clinical parameters .


Low-intensity pulsed ultrasound was found not to be an effective treatment for the healing of lower limb bone stress injuries in this study .


However , this was measured over a relatively short duration of @ weeks in a small , mostly female population .


This double-blinded , randomized , placebo-controlled trial has shown that LIPUS is not an effective treatment for lower limb bone stress injuries .


Vandetanib is an oral tyrosine kinase inhibitor of VEGFR-@ / @ , EGFR and RET , which has demonstrated clinical activity as a single agent and in combination with taxanes .


We explored the efficacy , safety and toxicity of docetaxel and vandetanib in women with recurrent ovarian cancer ( OC ) .


Women with refractory or progressive OC were randomised @:@ to docetaxel ( @ mg/m ( @ ) , IV ) + vandetanib ( @mg daily , PO , D+V ) or docetaxel ( @ mg/m ( @ ) , D ) .


Up to three additional cytotoxic regimens for recurrence and prior anti-angiogenic agents ( as primary therapy ) were allowed .


The primary end-point was progression free survival ( PFS ) .


The study had @ % power to detect a PFS hazard ratio of @ , using a one-sided P of @ .


This corresponds to an increase in median PFS from @ months to @ months .


Patients progressing on D were allowed to receive single agent vandetanib ( D V ) .


@ Patients were enrolled ; two were excluded .


@ % had received prior anti-angiogenic therapy .


The median PFS estimates were @ mos ( D+V ) versus @ ( D ) ; HR : @ ( @ % CI : @-@ @ ) .


@ Patients on D+V were assessable for toxicity ; @ ( @ % ) had treatment-related Grade ( G ) @ events , primarily haematologic .


Similarly , @ ( @ % ) of @ patients receiving D had G@ events , primarily haematologic .


@ Evaluable patients crossed-over to V. @/@ ( @ % ) experienced a G@ event .


G@ diarrhoea was observed in @ % D V patients .


Median OS was @ mos ( D+V ) versus @ mos ( D V ) ; HR ( OS ) : @ ( @ % CI : @-@ @ ) .


Crossover vandetanib response was @ % ( @/@ evaluable patients ) .


High plasma IL-@ levels were associated with response to D+V .


Combination docetaxel + vandetanib did not prolong PFS relative to docetaxel alone in OC patients .


No unexpected safety issues were identified .


To identify the effect of a novel augmented core stabilization exercise technique on physical function , pain and core stability in patients with chronic low back pain .


A block randomized controlled trial with two groups .


A sports rehabilitation clinic .


Forty patients with low back pain ( @ experimental , mean ( SD ) age @ ( @ ) years and @ control , @ ( @ ) ) , @ men and @ women .


In the experimental group ankle dorsiflexion was used in addition to drawing in the abdominal wall ; the control group involved drawing in the abdominal wall alone .


Both groups received the same conventional physical therapy training three days a week for eight weeks .


Physical disability instruments ; Oswestry Disability Index and Roland Morris Disability Questionnaire ; pain intensity assessments ; visual analogue scale , Pain Disability Index , and a pain rating scale ; and core stability measures , such as the active straight leg raise , were determined at pretest , posttest and two-month follow-up .


After the intervention , the experimental group showed significant greater improvement at two months compared with the control group .


Physical disability results included Oswestry Disability Index ( P = @ , from @ ( @ ) to @ ( @ ) ) and Roland Morris Disability Questionnaire ( P = @ , from @ ( @ ) to @ ( @ ) ) , pain intensity including visual analogue scale ( P = @ , from @ ( @ ) to @ ( @ ) ) , Pain Disability Index ( P = @ , @ ( @ ) to @ ( @ ) ) and pain rating scale ( P = @ , from @ ( @ ) to @ ( @ ) ) , and the core stability test such as active straight leg raise ( P = @ , from @ ( @ ) to @ ( @ ) ) .


This study provides the clinical evidence that adding ankle dorsiflexion to drawing in the abdominal wall gave increased benefit in terms of physical disability , pain and core stability in patients with chronic low back pain .


To explore the biomechanical changes induced by repeated cross-linking using scanning acoustic microscopy ( SAM ) .


Thirty human corneas were divided into three groups .


In group A , five corneas were cross-linked once .


In group B , five corneas were cross-linked twice , @ hours apart .


In group C , five corneas were cross-linked three times , @ hours apart .


The contralateral controls in all groups had similar treatment but without UV-A .


The speed of sound , which is directly proportional to the square root of the tissue 's elastic modulus , was assessed using SAM .


In group A , the speed of sound of the treated corneas was @ @ ms ( -@ ) anteriorly and @ @ ms ( -@ ) posteriorly , while it was @ @ ms ( -@ ) anteriorly and @ @ ms ( -@ ) posteriorly in the controls .


In group B , the speed of sound of the treated corneas was @ @ ms ( -@ ) anteriorly and @ @ ms ( -@ ) posteriorly , while it was @ @ ms ( -@ ) anteriorly and @ @ ms ( -@ ) posteriorly in the controls .


In group C , the speed of sound of the treated corneas was @ @ ms ( -@ ) anteriorly and @ @ ms ( -@ ) posteriorly , while it was @ @ ms ( -@ ) anteriorly and @ @ ms ( -@ ) posteriorly in the controls .


The speed of sound in the anterior ( @ @ m ) region between the cross-linked and control corneas in groups A , B , and C was increased by a factor of @ ( P = @ ) , @ ( P = @ ) , and @ ( P = @ ) respectively .


However , there was no significant difference among the cross-linked corneas in all groups ( P = @ ) .


A significant increase in speed of sound was found in all treated groups compared with the control group ; however , the difference among the treated groups is not significant , suggesting no further cross-links are induced when collagen cross-linking treatment is repeated .


Although consuming dietary protein above current recommendations during energy deficit ( ED ) preserves lean body mass , concerns have been raised regarding the effects of high-protein diets on bone health .


The objective was to determine whether calcium homeostasis and bone turnover are affected by high-protein diets during weight maintenance ( WM ) and ED .


In a randomized , parallel-design , controlled trial of @ men and @ women , volunteers were assigned diets providing protein at @ -LSB- Recommended Dietary Allowance ( RDA ) -RSB- , @ ( @ RDA ) , or @ ( @ RDA ) g kg ( -@ ) d ( -@ ) for @ d. Ten days of WM preceded @ d of ED , during which total daily ED was @ % , achieved by reduced dietary energy intake ( @ % ) and increased physical activity ( @ % ) .


The macronutrient composition ( protein g kg ( -@ ) d ( -@ ) and % fat ) was held constant from WM to ED .


Calcium absorption ( ratio of ( @ ) Ca to ( @ ) Ca ) and circulating indexes of bone turnover were determined at day @ ( WM ) and day @ ( ED ) .


Regardless of energy state , mean ( SEM ) urinary pH was lower ( P < @ ) at @ RDA ( @ @ ) and @ RDA ( @ @ ) than at the RDA ( @ @ ) .


However , protein had no effect on either urinary calcium excretion ( P > @ ) or the amount of calcium retained ( P > @ ) .


ED decreased serum insulin-like growth factor I concentrations and increased serum tartrate-resistant acid phosphatase and @-hydroxyvitamin D concentrations ( P < @ ) .


Remaining markers of bone turnover and whole-body bone mineral density and content were not affected by either the protein level or ED ( P > @ ) .


These data demonstrate that short-term consumption of high-protein diets does not disrupt calcium homeostasis and is not detrimental to skeletal integrity .


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


Malnutrition is an independent risk factor of postoperative morbidity and mortality and it 's observed in @ to @ % of surgical patients .


Preoperative interventions to optimize the nutritional status , reduce postoperative complications and enteral nutrition has proven to be superior to the parenteral one .


Moreover , regardless of the nutritional status of the patient , surgery impairs the immunological response , thus increasing the risk of postoperative sepsis .


Immunonutrition has been developed to improve the immunometabolic host response in perioperative period and it has been proven to reduce significantly postoperative infectious complications and length of hospital stay in patients undergoing elective gastrointestinal surgery for tumors .


We hypothesize that a preoperative oral immunonutrition ( ORAL IMPACT ) can reduce postoperative morbidity in liver resection for cancer .


Prospective multicenter randomized placebo-controlled double-blind phase IV trial with two parallel treatment groups receiving either study product ( ORAL IMPACT ) or control supplement ( isocaloric isonitrogenous supplement -- IMPACT CONTROL ) for @ days before liver resection for cancer .


A total of @ patients will be enrolled .


Patients will be stratified according to the type of hepatectomy , the presence of chronic liver disease and the investigator center .


The main end-point is to evaluate in intention-to-treat analysis the overall @-day morbidity .


Secondary end-points are to assess the @-day infectious and non-infectious morbidity , length of antibiotic treatment and hospital stay , modifications on total food intake , compliance to treatment , side-effects of immunonutrition , impact on liver regeneration and sarcopenia , and to perform a medico-economic analysis .


The overall morbidity rate after liver resection is @ % to @ % .


Infectious post-operative complications ( @ % to @ % ) increase the length of hospital stay and costs and are responsible for a quarter of @-day mortality .


Various methods have been advocated to decrease the rate of postoperative complications but there is no evidence to support or refute the use of any treatment and further trials are required .


The effects of preoperative oral immunonutrition in non-cirrhotic patients undergoing liver resection for cancer are unknown .


The present trial is designed to evaluate whether the administration of a short-term preoperative oral immunonutrition can reduce postoperative morbidity in non-cirrhotic patients undergoing liver resection for cancer .


Removal of the ovaries is common during surgery for endometrial cancer .


However , because loss of the ovaries can cause several health problems in patients , strategies for the prevention of such problems need to be established .


Hence , we decided to conduct a multicenter randomized clinical trial to assess the effect of raloxifene on bone mineral density ( BMD ) , bone metabolism , and the lipid profile of patients who had undergone surgery for patients with endometrial cancer .


Patients with endometrial cancer were enrolled after treatment .


The participants were randomized into @ groups : group @ included @ women who received alfacalcidol ( @ g/d ) alone and group @ included @ women who received alfacalcidol and the test drug , raloxifene hydrochloride , at a dose of @ mg/d .


The BMD of lumbar spine and femoral neck , serum bone markers , as well as lipid profile parameters were evaluated at enrollment as well as @ , @ , and @ months after the enrollment .


The primary efficacy end point was the percentage change from baseline to @ months in lumbar spine ( L@-L@ ) and femoral neck BMD .


Sixty-four women completed the @-month study .


At @ months , the lumbar and femoral neck BMDs were significantly increased in group @ compared with group @ ( @ % vs -@ % and @ % vs -@ % , respectively ) .


In group @ , low-density lipoprotein-cholesterol levels were significantly reduced by @ % and serum N-terminal telopeptide of type I collagen as well as bone-specific alkaline phosphatase values were significantly reduced by @ % and @ % , respectively .


The patients who received adjuvant therapy for endometrial cancer showed a significantly higher response to raloxifene ( @ % vs @ % ) .


Recurrence was detected in @ ( @ % ) patients in group @ .


No severe adverse events were noted in any patient during the study period .


Raloxifene exerts positive effects on BMD , bone metabolism , and lipid profile parameters and could provide an improved therapeutic option for patients with endometrial cancer .


There is a consensus that exercise therapy should be used as a therapeutic approach in chronic low back pain ( CLBP ) but little consensus has been reached about the preferential type of therapy .


Due to the heterogeneity of the population no clear effect of specific therapy interventions are found .


Probably a specific subgroup of the investigated population will benefit from the intervention and another subgroup will not benefit , looking at the total investigated population no significant effects can be found .


Therefore there is a need for the development of clinical prediction rules ( CPRs ) .


Objectives for this trial are first , the derivation of CPRs to predict treatment response to three forms of exercise therapy for patients with nonspecific CLBP .


Secondly , we aim to validate a CPR for the three forms of exercise therapy for patients with nonspecific CLBP .


The study design is a randomized controlled trial .


Patients with nonspecific CLBP of more than three months duration are recruited at the Antwerp University Hospital ( Belgium ) and Apra Rehabilitation Hospital .


After examination , patients are randomly assigned to one of three intervention groups : motor control therapy , general active exercise therapy and isometric training therapy .


All patients will undergo @ treatment sessions during nine weeks .


Measurements will be taken at baseline , nine weeks , six months and at one year .


The primary outcome used is the Modified Oswestry Disability Questionnaire score .


For each type of exercise therapy a CPR will be derived and validated .


For validation , the CPR will be applied to divide each treatment group into two subgroups ( matched and unmatched therapy ) using the baseline measurements .


We predict a better therapeutic effect for matched therapy .


A randomized controlled trial has not previously been performed for the development of a CPR for exercise therapy in CLBP patients .


Only one CPR was described in a single-arm design for motor control therapy in sub-acute non-radicular LBP patients .


In this study , a sufficiently large sample will be included in both the derivation and validation phase .


In a large randomised trial in patients with seasonal allergic rhinitis ( SAR ) , acupuncture was superior compared to sham acupuncture and rescue medication .


The aim of this paper is to describe the characteristics of the trial 's participating physicians and to describe the trial intervention in accordance with the STRICTA ( Standards for Reporting Interventions in Controlled Trials of Acupuncture ) guidelines , to make details of the trial intervention more transparent to researchers and physicians .


ACUSAR ( ACUpuncture in Seasonal Allergic Rhinitis ) was a three-armed , randomised , controlled multicentre trial .


@ SAR patients were randomised to semi-standardised acupuncture plus rescue medication ( RM , cetirizine ) , sham acupuncture plus RM or RM alone .


We sent a questionnaire to trial physicians in order to evaluate their characteristics regarding their education about and experience in providing acupuncture .


During the trial , acupuncturists were asked to diagnose all of their patients according to Chinese Medicine ( CM ) as a basis for the semi-standardised , individualized intervention in the acupuncture group .


Every acupuncture point used in this trial had to be documented after each session


Acupuncture was administered in outpatient clinics by @ ( mean age @years ; @ female / @ male ) conventionally-trained medical doctors ( @ % with postgraduate specialization such as internal or family medicine ) with additional extensive acupuncture training ( median @hours ( @st quartile @ , @rd quartile @hours with @ % presenting a B-diploma in acupuncture training ( @hours ) ) and experience ( mean @years in practice ) .


The most reported traditional CM diagnosis was ` wind-cold invading the lung ' ( @ % ) and ` wind-heat invading the lung ' ( @ % ) , followed by ` lung and spleen qi deficiency ' ( @ % ) .


The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group ( @ @ vs. @ @ ) .


The trial interventions were provided by well educated and experienced acupuncturists .


The different number of needles in both intervention groups could be possibly a reason for the better clinical effect in SAR patients .


For future trials it might be more appropriate to ensure that acupuncture and sham acupuncture groups should each be treated by a similar number of needles .


Current therapeutic options for Chagas ' disease are limited to benznidazole and nifurtimox , which have been associated with low cure rates in the chronic stage of the disease and which have considerable toxicity .


Posaconazole has shown trypanocidal activity in murine models .


We performed a prospective , randomized clinical trial to assess the efficacy and safety of posaconazole as compared with the efficacy and safety of benznidazole in adults with chronic Trypanosoma cruzi infection .


We randomly assigned patients to receive posaconazole at a dose of @ mg twice daily ( high-dose posaconazole ) , posaconazole at a dose of @ mg twice daily ( low-dose posaconazole ) , or benznidazole at a dose of @ mg twice daily ; all the study drugs were administered for @ days .


We assessed antiparasitic activity by testing for the presence of T. cruzi DNA , using real-time polymerase-chain-reaction ( rt-PCR ) assays , during the treatment period and @ months after the end of treatment .


Posaconazole absorption was assessed on day @ .


The intention-to-treat population included @ patients .


During the treatment period , all the patients tested negative for T. cruzi DNA on rt-PCR assay beyond day @ , except for @ patients in the low-dose posaconazole group who tested positive on day @ .


During the follow-up period , in the intention-to-treat analysis , @ % of the patients receiving low-dose posaconazole and @ % receiving high-dose posaconazole , as compared with @ % receiving benznidazole , tested positive for T. cruzi DNA on rt-PCR assay ( P < @ for the comparison of the benznidazole group with either posaconazole group ) ; in the per-protocol analysis , @ % of the patients receiving low-dose posaconazole and @ % of those receiving high-dose posaconazole , as compared with @ % receiving benznidazole , tested positive on rt-PCR assay ( P < @ for the comparison of the benznidazole group with either posaconazole group ) .


In the benznidazole group , treatment was discontinued in @ patients because of severe cutaneous reactions ; in the posaconazole groups , @ patients had aminotransferase levels that were more than @ times the upper limit of the normal range , but there were no discontinuations of treatment .


Posaconazole showed antitrypanosomal activity in patients with chronic Chagas ' disease .


However , significantly more patients in the posaconazole groups than in the benznidazole group had treatment failure during follow-up .


( Funded by the Ministry of Health , Spain ; CHAGASAZOL ClinicalTrials.gov number , NCT@ . )


This study sought to determine clinical , procedural , and treatment factors associated with acute stent thrombosis ( AST ) in the EUROMAX ( European Ambulance Acute Coronary Syndrome Angiography ) trial .


Bivalirudin started during transport for primary percutaneous coronary intervention ( PCI ) for ST-segment elevation myocardial infarction significantly reduced major bleeding compared with heparin with or without glycoprotein IIb/IIIa inhibitors ( GPI ) , but it was associated with an increase in AST .


We compared patients with ( n = @ ) or without AST ( n = @,@ ) regarding baseline , clinical , and procedural characteristics and antithrombotic treatment strategies ( choice of P@Y@ inhibitor , post-primary PCI bivalirudin infusion dose -LSB- @ mg/kg/h , or BIV-LOW -RSB- vs. -LSB- @ mg/kg/h , or BIV-PCI -RSB- vs. heparin GPI ) .


Logistic regression was performed to identify independent correlates of AST .


The overall AST rate was @ % and was higher with bivalirudin than with heparin GPI ( @ % vs. @ % ; p = @ ) .


Median time to AST was @ h ( interquartile range : @ to @ h ) .


Patients with AST had less hypertension ( @ of @ -LSB- @ % -RSB- vs. @ of @,@ -LSB- @ % -RSB- ; p = @ ) , and more frequently received GPI ( @ of @ -LSB- @ % -RSB- vs. @ of @,@ -LSB- @ % -RSB- ; p = @ ) .


Multivariate analysis using Firth penalized maximum likelihood estimation found hypertension ( odds ratio -LSB- OR -RSB- : @ , @ % confidence interval -LSB- CI -RSB- : @ to @ ; p = @ ) and BIV-LOW ( OR : @ , @ % CI : @ to @ ; p = @ ) predictive of AST .


Choice of P@Y@ inhibitor had no impact on AST .


Compared with heparin GPI , AST rates were higher for BIV-LOW ( @ of @ -LSB- @ % -RSB- vs. @ of @ -LSB- @ % -RSB- ; p = @ ) , but not different for BIV-PCI ( @ of @ -LSB- @ % -RSB- ; p = @ ) .


In this post-hoc analysis from EUROMAX , AST occurred very early and was not mitigated by the novel P@Y@ inhibitors .


Prolonging the bivalirudin infusion at the PCI dose ( but not at a lower dose ) appeared to mitigate the risk of AST .


The PENPACT-@ trial compared virologic thresholds to determine when to switch to second-line antiretroviral therapy ( ART ) .


Using PENPACT-@ data , we aimed to describe HIV-@ drug resistance accumulation on first-line ART by virologic threshold .


PENPACT-@ had a @ @ factorial design , randomizing HIV-infected children to start protease inhibitor ( PI ) versus nonnucleoside reverse transcriptase inhibitor ( NNRTI ) - based ART , and switch at a @ copies/mL versus @,@ copies/mL threshold .


Switch criteria were not achieving the threshold by week @ , confirmed rebound above the threshold thereafter , or Center for Disease Control and Prevention stage C event .


Resistance tests were performed on samples @ copies/mL before switch , resuppression , and at @-years/trial end .


Sixty-seven children started PI-based ART and were randomized to switch at @ copies/mL ( PI-@ ) , @ PIs and @,@ copies/mL ( PI-@ ,@ ) , @ NNRTIs and @ copies/mL ( NNRTI-@ ) , and @ NNRTI and @,@ copies/mL ( NNRTI-@ ,@ ) .


Ninety-four ( @ % ) children reached the @ copies/mL switch criteria during @-year follow-up .


In @,@ copies/mL threshold arms , median time from @ to @,@ copies/mL switch criteria was @ ( PI ) versus @ ( NNRTI ) weeks ( P = @ ) .


In NNRTI-@ ,@ , more nucleoside reverse transcriptase inhibitor ( NRTI ) resistance mutations accumulated than other groups .


NNRTI mutations were selected before switching at @ copies/mL ( @ % NNRTI-@ , @ % NNRTI-@ ,@ ) .


Sixty-two children started abacavir + lamivudine , @ lamivudine + zidovudine or stavudine , and @ other NRTIs .


The abacavir + lamivudine group acquired fewest NRTI mutations .


Of @ switched to second-line , @ % PI-@ , @ % PI-@ ,@ , @ % NNRTI-@ , and @ % NNRTI-@ ,@ were < @ copies/mL @ weeks later .


Children on first-line NNRTI-based ART who were randomized to switch at a higher virologic threshold developed the most resistance , yet resuppressed on second-line .


An abacavir + lamivudine NRTI combination seemed protective against development of NRTI resistance .


Morbidly obese patients are more prone to desaturation of arterial blood during apnea with induction of anesthesia than are non-obese .


This study aimed to assess the effect of low-pressure continuous positive airway pressure ( CPAP ) with pressure support ventilation ( PSV ) during pre-oxygenation on partial oxygen pressure in arterial blood ( PaO@ ) immediately after tracheal intubation ( post-intubation PaO@ ) .


Forty-four adult patients scheduled for laparoscopic gastric bypass surgery were pre-oxygenated with @ % O@ for @ min , randomized either to CPAP @ cm H@O + PSV @ cm H@O ( CPAP/PSV , n = @ ) or neutral-pressure breathing without CPAP/PSV ( control , n = @ ) .


Anesthesia was induced in a rapid-sequence protocol and the trachea was intubated without prior mask ventilation .


Arterial blood gases were measured before pre-oxygenation , before induction of anesthesia , and immediately following intubation , before the first positive pressure breath .


After pre-oxygenation , partial carbondioxide pressure was significantly lower in the CPAP/PSV group ( @ @ kPa ) , ( mean standard deviation ) than in the control group ( @ @ kPa ) ( P = @ ) .


Post-preoxygenation PaO@ did not differ between the groups , but post-intubation PaO@ was significantly higher in the CPAP/PSV group ( @ @ kPa ) than in the control group ( @ @ kPa ) ( P < @ ) .


In the control group , nadir oxygen saturation was lower ( median @ % , range @-@ % ) than in the CPAP/PSV group ( median @ % , range @-@ % , P = @ ) .


In morbidly obese patients , low-pressure CPAP combined with low-pressure PSV during pre-oxygenation resulted in better oxygenation , compared with neutral-pressure breathing , and prevented desaturation episodes .


The internal thoracic artery ( ITA ) has been accepted worldwide as a first choice conduit for myocardial revascularisation .


It still remains questionable what is the best method for ITA harvesting in a skeletonized fashion according to structural integrity of artery , as a risk factor of early and late graft failure .


The purpose of this study was to determine the impact of the ultra-high radiofrequency energy used for ITA harvesting on arterial structural integrity , in particular on the endothelial layer .


Seventy-four ITA specimens were divided into two groups depending on device used for harvesting ( radiofrequency-knife ( RF ) or electrocauter ( EC ) ) .


Thermal damage on arterial structural integrity was measured using light microscope , morphometric imaging analysis and immunohistochemical methods .


Thermal damage of endothelium was @ times higher in EC than in RF group ( p = @ ) and @ times higher in patients older than @ years of age ( p = @ ) .


Extent of endothelial damage ( graded from @ to @ ) was significantly higher in EC group ( p = @ ) .


Also , in EC group , in patients older than @ years of age higher proportion of extent of endothelial damage was found ( p = @ ) .


The endothelial damage was more often in EC than in RF group as in the patients older than @ years of age .


Demonstrated results suggest that the radiosurgery in comparison to conventional electrocautery is safe and effective method , and significantly reduces thermal damage to endothelial layer of artery .


To assess the efficacy and safety of imidafenacin compared with propiverine for treatment of overactive bladder ( OAB ) in Korean patients .


Patients with OAB symptoms were randomised to double-blind treatment with @ mg of imidafenacin twice daily ( group A ) or propiverine @ mg once daily ( group B ) for @-week regimen , and assessed for efficacy and safety .


The primary efficacy outcome was per cent change of weekly urgency urinary incontinence ( UUI ) episodes at week @ .


The secondary efficacy outcomes were changes in the micturitions per day , urine volume voided per micturition , urgency episodes per day , complete disappearance of incontinence episodes and severity of urgency from baseline to week @ .


Quality of life and safety profiles were also compared .


Of @ patients randomised , @ completed the study protocol .


The per cent change of weekly UUI episodes at week @ was -@ % in group A and -@ % in group B ( both p < @ ) .


The lower limit of @ % one-sided confidence interval of the difference between the groups was above the non-inferiority margin ( -@ % ) .


Other voiding parameters and quality of life significantly improved at week @ in both the groups .


The discontinuation rates caused by adverse events were low in both the groups .


While dry mouth was the most common adverse event ( group A : @ % vs. B : @ % , p = @ ) , the severity of dry mouth was significantly less in the group A than B ( p = @ ) There were no significant differences in other safety profiles .


After the @-week treatment of imidafenacin @ mg twice daily , all OAB symptoms and quality of life improved .


Imidafenacin was not inferior to propiverine for the reduction of UUI episodes , and was better tolerated than propiverine in the safety profile .


Our results indicate that imidafenacin is a safe and effective drug in Korean patients with OAB .


Infants with unilateral brain lesions are at high risk of developing unilateral cerebral palsy ( CP ) .


Given the great plasticity of the young brain , possible interventions for infants at risk of unilateral CP deserve exploration .


Constraint-induced movement therapy ( CIMT ) is known to be effective for older children with unilateral CP but is not systematically used for infants .


The development of CIMT for infants ( baby-CIMT ) is described here , as is the methodology of an RCT comparing the effects on manual ability development of baby-CIMT versus baby-massage .


The main hypothesis is that infants receiving baby-CIMT will develop manual ability in the involved hand faster than will infants receiving baby-massage in the first year of life .


The study will be a randomised , controlled , prospective parallel-group trial .


Invited infants will be to be randomised to either the baby-CIMT or the baby-massage group if they : @ ) are at risk of developing unilateral CP due to a known neonatal event affecting the brain or @ ) have been referred to Astrid Lindgren Children 's Hospital due to asymmetric hand function .


The inclusion criteria are age @-@ months and established asymmetric hand use .


Infants in both groups will receive two @-weeks training periods separated by a @-week pause , for @ weeks in total of treatment .


The primary outcome measure will be the new Hand Assessment for Infants ( HAI ) for evaluating manual ability .


In addition , the Parenting Sense of Competence scale and Alberta Infant Motor Scale will be used .


Clinical neuroimaging will be utilized to characterise the brain lesion type .


To compare outcomes between treatment groups generalised linear models will be used .


The model of early intensive intervention for hand function , baby-CIMT evaluated by the Hand Assessment for Infants ( HAI ) will have the potential to significantly increase our understanding of how early intervention of upper limb function in infants at risk of developing unilateral CP can be performed and measured .


CRTH@ is a G-protein-coupled receptor on T helper@ cells that mediates pro-inflammatory effects of prostaglandin D@ in allergic responses .


To investigate the tolerability and pharmacokinetics of setipiprant ( ACT-@ ) , a selective orally active CRTH@ antagonist , in allergic asthmatics and to assess the protective effects of multiple doses of this drug against allergen-induced airway responses .


In this @-centre , double-blinded , placebo-controlled , cross-over study , @ allergic asthmatic males were randomized to setipiprant @ mg or matching placebo b.i.d. for @ consecutive days .


Study periods were separated by a washout of @ weeks .


On study day @ , subjects underwent a standardized allergen challenge and airway response was recorded by FEV@ until @ h post-allergen .


Airway responsiveness to methacholine and exhaled nitric oxide ( eNO ) were measured pre - and post-dosing .


The effects of both treatments on the allergen-induced airway responses were compared by a paired Student 's t-test .


Fifteen subjects completed the study per-protocol and were included in the analysis .


Overall , setipiprant was well tolerated and no clinically relevant adverse events occurred .


Trough plasma concentrations showed a high inter-subject variability .


Compared with placebo , setipiprant significantly reduced the allergen-induced late asthmatic response ( LAR ) , inhibiting the area under the response vs. time curve ( AUC ( @-@ h ) ) by on average @ % ( P = @ ) and significantly protected against the allergen-induced airway hyperresponsiveness ( AHR ) to methacholine ( P = @ ) .


There was no difference in the early asthmatic response ( EAR ) or in allergen-induced changes in eNO between treatments .


Setipiprant at multiple oral doses was well tolerated and reduced both the allergen-induced LAR and the associated AHR in allergic asthmatics .


Our findings confirm that CRTH@ may be a promising target for the treatment of allergic disorders .


Evidences suggest that nuts consumption can improve energy metabolism .


This study aimed to compare the effects of acute ingestion of high-oleic and conventional peanuts on appetite , food intake , and energy metabolism in overweight and obese men .


Seventy one subjects ( @ @ kg/m@ ) were assigned to the groups : control ( CT , n = @ ) ; conventional peanuts ( CVP , n = @ ) ; high-oleic peanuts ( HOP , n = @ ) .


Subjects consumed @ g of peanuts ( CVP and HOP ) or control biscuits ( CT ) after overnight fasting .


Thereafter , energy metabolism was evaluated over @ minutes , during which diet-induced thermogenesis ( DIT ) and substrate oxidation were analyzed .


Appetite sensation was recorded for @ hours .


Statistical analyses were performed using the SAS software considering @ % as the significance level .


Postprandial energy expenditure and DIT were significantly higher in HOP than in CVP .


Substrate oxidation did not differ between groups .


Only HOP presented score below @ indicating incomplete compensation .


CT and CVP showed a complete caloric compensation ( scores > @ ) .


Regarding appetite sensation , CVP group felt less `` full '' than HOP and CT. .


After @ hours , satiety score of CVP returned to baseline , whereas HOP and CT remained significantly higher .


Hunger scores returned to baseline in CVP and CT and they were maintained significantly lowered in HOP .


High-oleic peanuts contributed to higher DIT , higher sensation of fullness and incomplete compensation for energy intake compared to conventional peanuts and may be useful to dietary intervention to reduce body weight .


Muscle relaxant is commonly used in general anesthesia to facilitate surgery .


When finishing the operation , anesthesiologists reverse the muscle relaxant with anticholinesterase , neostigmine , combined with anticholinergic for prevention of unwanted side effects from neostigmine .


The only existed anticholinergic in Thailand is atropine , which has a more rapid onset than neostigmine resulting in initial tachycardia .


Lately , we have glycopyrrolate that cause less increase in initial heart rate .


Therefore , we would like to study the effect of heart rate of the combination between atropine and glycopyrrolate to counteract the effect of neostigmine .


Evaluate the different increase in heart rate after the reversal of muscle relaxant with neostigmine combined with atropine or glycopyrrolate plus atropine .


The study was a randomized controlled trial study .


Fifty-one , ASA I or II patients undergoing elective gynecological surgery under general anesthesia technique were enrolled in the present study .


They were randomly assigned by computer-generated random sequence into two groups , control group and intervention group .


Control group received neostigmine @ mg and atropine @ mg , intervention group received neostigmine @ mg , glycopyrrolate @ mg and atropine @ mg for reversal of neuromuscular block after finishing the operation .


Both groups received the same anesthetic agents including muscle relaxant .


Heart rate was recorded before drugs administration and at @ , @ , @ , and @ minutes after injection .


We also recorded heart rate in the PA CU at @ , @ , @ , @ , and @ minutes .


Secondary outcome was incidence of arrhythmia during the observation in PACU .


There was no difference in age and baseline heart rate between the two groups .


There was no different increase in heart rate after administration of reversal agent between control group and intervention group at any time ( p-value = @ ) .


No incidence of significant arrhythmia in both groups .


There is no significant different increase in heart rate in @ mg glycopyrrolate plus @ mg atropine group compared to @ mg atropine alone for antagonizing muscarinic effects of @ mg neostigmine .


Therefore , atropine @ mg and glycopyrrolate @ mg is an alternative to antagonize muscarinic effects of neostigmine .


Increased DNA methylation of the metabolic regulator peroxisome proliferator-activated receptor gamma coactivator @ alpha ( PPARGC@A ) has been reported in skeletal muscle from type @ diabetes ( T@D ) subjects and from low birth weight ( LBW ) subjects with an increased risk of T@D .


High-fat overfeeding increases PPARGC@A DNA methylation in muscle in a birth weight dependent manner .


However , PPARGC@A DNA methylation in subcutaneous adipose tissue ( SAT ) in LBW subjects has not previously been investigated .


Our objective was to determine PPARGC@A DNA methylation and mRNA expression in basal and insulin-stimulated SAT from LBW and matched normal birth weight ( NBW ) subjects during control and high-fat overfeeding .


Nineteen young healthy men with LBW and @ NBW controls were studied after both a @-day high-fat overfeeding and a control diet in a randomized crossover setting .


DNA methylation was assessed with bisulfite sequencing and mRNA expression with quantitative real-time PCR .


Following high-fat overfeeding , increased SAT PPARGC@A DNA methylation was observed in LBW subjects but not in NBW controls .


Basal SAT PPARGC@A mRNA expression was unaffected by diet and similar in the two groups .


However , LBW subjects showed an increased SAT PPARGC@A mRNA expression during insulin-stimulation .


SAT PPARGC@A methylation correlated inversely with mRNA expression during insulin-stimulation .


The study adds to the increasing awareness of PPARGC@A DNA methylation being flexible and influenced by high-fat overfeeding in a birth weight dependent manner with muscle and fat responding differently .


Further data are needed to understand the role of PPARGC@A DNA methylation in insulin resistance and developmental programming of T@D .


The aim of the study was to compare the effects of @ strategies of antiplatelet treatment ( i.e. , @ mg ASA vs. @ mg clpoidogrel ) on plasma level of inflammatory markers in type @ diabetes mellitus ( T@DM ) patients with high platelet reactivity ( HPR ) .


Study cohort consisted of @ T@DM patients on chronic ASA therapy ( @ mg per day ) participating in the Aspirin Versus/Or Clopidogrel in Aspirin-resistant Diabetics inflammation Outcomes ( AVOCADO ) study .


Patients with HPR defined as Platelet Function Analyzer ( PFA ) -@ collagene/epinephrine closure time ( CEPI-CT ) < @ s ( n = @ ) were randomized to @ mg of ASA or @ mg of clopidogrel in @:@ ratio , respectively .


Concentrations of the selected inflammatory markers , including tumor necrosis factor ( TNF ) - , interleukin ( IL ) -@ , solubleCD@ ligand ( sCD@L ) , and high sensitivity C-reactive protein ( hsCRP ) , were measured and compared in both treatment groups before and after @ weeks of treatment in both groups .


Out of @ patients included into final analysis , the total of @ % ( n = @ ) patients displayed HPR , of which @ % ( n = @ ) were randomized into @ mg of ASA group and @ % ( n = @ ) into @ mg of clopidogrel group .


Treatment with clopidogrel was a positive predictor ( stepwise multiple regression analysis ) of reduction of sCD@L concentration ( odds ratio -LSB- OR -RSB- @ ; p = @ ) , while treatment with @ mg ASA was a positive predictor of reduction of IL-@ concentration ( OR @ ; p = @ ) .


There was no statistically significant differences between clopidogrel and ASA @ mg treatment in respect to predictive value for decreased hsCRP concentrations or increased TNF - concentrations .


Increasing the dose of ASA from @ mg to @ mg daily or switching ASA @ mg to clopidogrel @ mg daily may reduce concentrations of some inflammatory markers ( in particular hsCRP , IL-@ and CD@L ) in T@DM patients with HPR treated previously with @ mg of ASA .


Negative-calorie diets ( NCDs ) are among the popular dieting guides for weight loss ; however , there is still little knowledge about this method .


The present study aimed to determine the effects of a NCD supplemented with exercise on weight loss and lipid profile , and to compare its efficiency with low-calorie diets ( LCDs ) with exercise among elderly adult men with abnormal weight gain .


Participants included sedentary men ( aged @-@ years ) who were overweight or obese ( n = @ ) .


They were randomly divided into @ groups : a group with a NCD and exercise , and a group with a LCD with exercise .


Of all @ participants , @ completed the treatment .


Weight assessment parameters , including changes in weight and body composition and blood sample tests , were performed before and @ months after intervention .


All parameters decreased significantly in both groups .


Elevation in high-density lipoprotein ( HDL ) cholesterol levels ( P < @ ) was different between the @ groups .


The decline in the total cholesterol to HDL cholesterol ratio was greater in the LCD than the NCD group .


Contrary to expectations , both weight-loss diets were equally efficacious .


Instruments that enable to select individuals that will benefit most from bariatric surgery ( BS ) are necessary to increase its cost-efficiency .


Our goal was to assess if intake capacity , measured with a standardized test , predicts response to BS .


Patients with criteria for BS were randomly allocated to laparoscopic gastric bypass ( LRYGB ) or sleeve gastrectomy ( LSG ) .


We measured caloric intake capacity before and @ year after surgery using a standardized nutrient drink test .


We evaluated if pre-surgery satiation could predict satiation and weight loss ( % ) @ year after surgery using multiple regression modeling .


Descriptive statistics are given as mean SD .


Fourteen women ( @ @ years old , BMI @ @ kg/m ( @ ) ) were evaluated before and @ @ months after surgery ( seven LRYGB , seven LSG ) .


Caloric intake capacity diminished after surgery ( -@ @ kcal on average -LSB- @ @ % decrease over basal intake capacity -RSB- ; p = @ ) and similarly in both LRYGB ( @ % decrease ) and LSG groups ( @ % decrease ) ; p = @ .


There was a significant weight reduction after surgery ( -@ @ kg -LSB- @ @ % of total basal weight -RSB- ) with a mean post-surgery BMI of @ kg/m ( @ ) .


The best predictive model of weight loss ( % ) after surgery ( R ( @ ) = @ % , p = @ ) included : BMI ( p = @ ) , surgery type ( p = @ ) and pre-surgery intake capacity ( p = @ ) .


Weight loss was higher in heavier patients and those undergoing LRYGB .


Patients with higher intake capacity had a poorer outcome independently of basal BMI and surgery type .


Caloric intake capacity , as measured by a standard nutrient drink test , helps to predict weight loss after bariatric surgery .


This test might be useful in algorithms of obesity treatment decision .


To examine the effects of Hatha yoga therapy on resilience , brain-derived neurotrophic factor ( BDNF ) levels , and salivary alpha amylase ( SAA ) activity in patients with schizophrenia-spectrum disorders .


Single-blinded , randomized controlled study in which outpatients with schizophrenia or related psychotic disorders ( according to International Classification of Diseases , @th Revision ) were randomly assigned to a yoga or a control group .


November @-April @ at Yamanashi Prefectural Kita Hospital , Japan .


In the yoga group , patients received weekly @-hour Hatha yoga sessions , in addition to regular treatment , for @ weeks .