The study had 84 % power to detect a PFS hazard ratio of 0.65 , using a one-sided P of 0.1 .


This corresponds to an increase in median PFS from 3.6 months to 5.6 months .


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


131 Patients were enrolled ; two were excluded .


16 % had received prior anti-angiogenic therapy .


The median PFS estimates were 3.0 mos ( D+V ) versus 3.5 ( D ) ; HR : 0.99 ( 80 % CI : 0.79-1 .26 ) .


61 Patients on D+V were assessable for toxicity ; 20 ( 33 % ) had treatment-related Grade ( G ) 4 events , primarily haematologic .


Similarly , 17 ( 27 % ) of 64 patients receiving D had G4 events , primarily haematologic .


27 Evaluable patients crossed-over to V. 1/27 ( 4 % ) experienced a G4 event .


G3 diarrhoea was observed in 4 % D V patients .


Median OS was 14 mos ( D+V ) versus 18 mos ( D V ) ; HR ( OS ) : 1.25 ( 80 % CI : 0.93-1 .68 ) .


Crossover vandetanib response was 4 % ( 1/27 evaluable patients ) .


High plasma IL-8 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 ( 20 experimental , mean ( SD ) age 50.35 ( 9.26 ) years and 20 control , 51.30 ( 7.01 ) ) , 19 men and 21 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 = 0.001 , from 24.25 ( 7.08 ) to 13.35 ( 4.17 ) ) and Roland Morris Disability Questionnaire ( P = 0.001 , from 15.55 ( 1.99 ) to 8.15 ( 1.69 ) ) , pain intensity including visual analogue scale ( P = 0.001 , from 6.30 ( 1.03 ) to 3.35 ( 0.59 ) ) , Pain Disability Index ( P = 0.001 , 31.25 ( 5.44 ) to 19.00 ( 3.58 ) ) and pain rating scale ( P = 0.001 , from 72.25 ( 18.73 ) to 50.10 ( 15.47 ) ) , and the core stability test such as active straight leg raise ( P = 0.001 , from 7.40 ( 0.75 ) to 2.15 ( 0.49 ) ) .


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 , 24 hours apart .


In group C , five corneas were cross-linked three times , 24 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 1677.38 10.70 ms ( -1 ) anteriorly and 1603.90 9.82 ms ( -1 ) posteriorly , while it was 1595.23 9.66 ms ( -1 ) anteriorly and 1577.13 8.16 ms ( -1 ) posteriorly in the controls .


In group B , the speed of sound of the treated corneas was 1746.33 23.37 ms ( -1 ) anteriorly and 1631.60 18.92 ms ( -1 ) posteriorly , while it was 1637.57 22.15 ms ( -1 ) anteriorly and 1612.30 22.23 ms ( -1 ) posteriorly in the controls .


In group C , the speed of sound of the treated corneas was 1717.97 18.92 ms ( -1 ) anteriorly and 1616.62 17.58 ms ( -1 ) posteriorly , while it was 1628.69 9.37 ms ( -1 ) anteriorly and 1597.68 11.97 ms ( -1 ) posteriorly in the controls .


The speed of sound in the anterior ( 200 200 m ) region between the cross-linked and control corneas in groups A , B , and C was increased by a factor of 1.051 ( P = 0.005 ) , 1.066 ( P = 0.010 ) , and 1.055 ( P = 0.005 ) respectively .


However , there was no significant difference among the cross-linked corneas in all groups ( P = 0.067 ) .


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 32 men and 7 women , volunteers were assigned diets providing protein at 0.8 [ Recommended Dietary Allowance ( RDA ) ] , 1.6 ( 2 RDA ) , or 2.4 ( 3 RDA ) g kg ( -1 ) d ( -1 ) for 31 d. Ten days of WM preceded 21 d of ED , during which total daily ED was 40 % , achieved by reduced dietary energy intake ( 30 % ) and increased physical activity ( 10 % ) .


The macronutrient composition ( protein g kg ( -1 ) d ( -1 ) and % fat ) was held constant from WM to ED .


Calcium absorption ( ratio of ( 44 ) Ca to ( 42 ) Ca ) and circulating indexes of bone turnover were determined at day 8 ( WM ) and day 29 ( ED ) .


Regardless of energy state , mean ( SEM ) urinary pH was lower ( P < 0.05 ) at 2 RDA ( 6.28 0.05 ) and 3 RDA ( 6.23 0.06 ) than at the RDA ( 6.54 0.06 ) .


However , protein had no effect on either urinary calcium excretion ( P > 0.05 ) or the amount of calcium retained ( P > 0.05 ) .


ED decreased serum insulin-like growth factor I concentrations and increased serum tartrate-resistant acid phosphatase and 25-hydroxyvitamin D concentrations ( P < 0.01 ) .


Remaining markers of bone turnover and whole-body bone mineral density and content were not affected by either the protein level or ED ( P > 0.05 ) .


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 NCT01292395 .


Malnutrition is an independent risk factor of postoperative morbidity and mortality and it 's observed in 20 to 50 % 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 7 days before liver resection for cancer .


A total of 400 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 30-day morbidity .


Secondary end-points are to assess the 30-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 22 % to 42 % .


Infectious post-operative complications ( 12 % to 23 % ) increase the length of hospital stay and costs and are responsible for a quarter of 30-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 .


Clinicaltrial.gov : NCT02041871 .


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 2 groups : group 1 included 39 women who received alfacalcidol ( 1 g/d ) alone and group 2 included 37 women who received alfacalcidol and the test drug , raloxifene hydrochloride , at a dose of 60 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 6 , 12 , and 24 months after the enrollment .


The primary efficacy end point was the percentage change from baseline to 24 months in lumbar spine ( L2-L4 ) and femoral neck BMD .


Sixty-four women completed the 24-month study .


At 24 months , the lumbar and femoral neck BMDs were significantly increased in group 2 compared with group 1 ( 3.5 % vs -0.8 % and 2.3 % vs -2.8 % , respectively ) .


In group 2 , low-density lipoprotein-cholesterol levels were significantly reduced by 13.6 % and serum N-terminal telopeptide of type I collagen as well as bone-specific alkaline phosphatase values were significantly reduced by 16.7 % and 25.7 % , respectively .


The patients who received adjuvant therapy for endometrial cancer showed a significantly higher response to raloxifene ( 5.8 % vs 1.9 % ) .


Recurrence was detected in 2 ( 2.6 % ) patients in group 1 .


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 18 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 .


This trial was registered with Clinicaltrials.gov on 10 February 2014 , registration number : NCT02063503 .


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 .


422 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 46 ( mean age 4710years ; 24 female / 22 male ) conventionally-trained medical doctors ( 67 % with postgraduate specialization such as internal or family medicine ) with additional extensive acupuncture training ( median 500hours ( 1st quartile 350 , 3rd quartile 1000hours with 73 % presenting a B-diploma in acupuncture training ( 350hours ) ) and experience ( mean 14years in practice ) .


The most reported traditional CM diagnosis was ` wind-cold invading the lung ' ( 37 % ) and ` wind-heat invading the lung ' ( 37 % ) , followed by ` lung and spleen qi deficiency ' ( 9 % ) .


The total number of needles used was higher in the acupuncture group compared to the sham acupuncture group ( 15.7 2.5 vs. 10.0 1.6 ) .


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 .


ClinicalTrials.gov : NCT00610584 .


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 400 mg twice daily ( high-dose posaconazole ) , posaconazole at a dose of 100 mg twice daily ( low-dose posaconazole ) , or benznidazole at a dose of 150 mg twice daily ; all the study drugs were administered for 60 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 10 months after the end of treatment .


Posaconazole absorption was assessed on day 14 .


The intention-to-treat population included 78 patients .


During the treatment period , all the patients tested negative for T. cruzi DNA on rt-PCR assay beyond day 14 , except for 2 patients in the low-dose posaconazole group who tested positive on day 60 .


During the follow-up period , in the intention-to-treat analysis , 92 % of the patients receiving low-dose posaconazole and 81 % receiving high-dose posaconazole , as compared with 38 % receiving benznidazole , tested positive for T. cruzi DNA on rt-PCR assay ( P < 0.01 for the comparison of the benznidazole group with either posaconazole group ) ; in the per-protocol analysis , 90 % of the patients receiving low-dose posaconazole and 80 % of those receiving high-dose posaconazole , as compared with 6 % receiving benznidazole , tested positive on rt-PCR assay ( P < 0.001 for the comparison of the benznidazole group with either posaconazole group ) .


In the benznidazole group , treatment was discontinued in 5 patients because of severe cutaneous reactions ; in the posaconazole groups , 4 patients had aminotransferase levels that were more than 3 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 , NCT01162967 . )


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 = 12 ) or without AST ( n = 2,184 ) regarding baseline , clinical , and procedural characteristics and antithrombotic treatment strategies ( choice of P2Y12 inhibitor , post-primary PCI bivalirudin infusion dose [ 0.25 mg/kg/h , or BIV-LOW ] vs. [ 1.75 mg/kg/h , or BIV-PCI ] vs. heparin GPI ) .


Logistic regression was performed to identify independent correlates of AST .


The overall AST rate was 0.6 % and was higher with bivalirudin than with heparin GPI ( 1.1 % vs. 0.2 % ; p = 0.007 ) .


Median time to AST was 2.3 h ( interquartile range : 1.9 to 2.8 h ) .


Patients with AST had less hypertension ( 2 of 14 [ 14.0 % ] vs. 961 of 2,182 [ 44.0 % ] ; p = 0.03 ) , and more frequently received GPI ( 11 of 14 [ 78.6 % ] vs. 880 of 2,183 [ 40.3 % ] ; p = 0.004 ) .


Multivariate analysis using Firth penalized maximum likelihood estimation found hypertension ( odds ratio [ OR ] : 0.24 , 95 % confidence interval [ CI ] : 0.07 to 0.92 ; p = 0.037 ) and BIV-LOW ( OR : 5.8 , 95 % CI : 1.5 to 22.2 ; p = 0.010 ) predictive of AST .


Choice of P2Y12 inhibitor had no impact on AST .


Compared with heparin GPI , AST rates were higher for BIV-LOW ( 11 of 670 [ 1.6 % ] vs. 2 of 947 [ 0.2 % ] ; p = 0.008 ) , but not different for BIV-PCI ( 1 of 244 [ 0.4 % ] ; p = 0.588 ) .


In this post-hoc analysis from EUROMAX , AST occurred very early and was not mitigated by the novel P2Y12 inhibitors .


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


The PENPACT-1 trial compared virologic thresholds to determine when to switch to second-line antiretroviral therapy ( ART ) .


Using PENPACT-1 data , we aimed to describe HIV-1 drug resistance accumulation on first-line ART by virologic threshold .


PENPACT-1 had a 2 2 factorial design , randomizing HIV-infected children to start protease inhibitor ( PI ) versus nonnucleoside reverse transcriptase inhibitor ( NNRTI ) - based ART , and switch at a 1000 copies/mL versus 30,000 copies/mL threshold .


Switch criteria were not achieving the threshold by week 24 , confirmed rebound above the threshold thereafter , or Center for Disease Control and Prevention stage C event .


Resistance tests were performed on samples 1000 copies/mL before switch , resuppression , and at 4-years/trial end .


Sixty-seven children started PI-based ART and were randomized to switch at 1000 copies/mL ( PI-1000 ) , 64 PIs and 30,000 copies/mL ( PI-30 ,000 ) , 67 NNRTIs and 1000 copies/mL ( NNRTI-1000 ) , and 65 NNRTI and 30,000 copies/mL ( NNRTI-30 ,000 ) .


Ninety-four ( 36 % ) children reached the 1000 copies/mL switch criteria during 5-year follow-up .


In 30,000 copies/mL threshold arms , median time from 1000 to 30,000 copies/mL switch criteria was 58 ( PI ) versus 80 ( NNRTI ) weeks ( P = 0.81 ) .


In NNRTI-30 ,000 , more nucleoside reverse transcriptase inhibitor ( NRTI ) resistance mutations accumulated than other groups .


NNRTI mutations were selected before switching at 1000 copies/mL ( 23 % NNRTI-1000 , 27 % NNRTI-30 ,000 ) .


Sixty-two children started abacavir + lamivudine , 166 lamivudine + zidovudine or stavudine , and 35 other NRTIs .


The abacavir + lamivudine group acquired fewest NRTI mutations .


Of 60 switched to second-line , 79 % PI-1000 , 63 % PI-30 ,000 , 64 % NNRTI-1000 , and 100 % NNRTI-30 ,000 were < 400 copies/mL 24 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 ( PaO2 ) immediately after tracheal intubation ( post-intubation PaO2 ) .


Forty-four adult patients scheduled for laparoscopic gastric bypass surgery were pre-oxygenated with 80 % O2 for 2 min , randomized either to CPAP 5 cm H2O + PSV 5 cm H2O ( CPAP/PSV , n = 22 ) or neutral-pressure breathing without CPAP/PSV ( control , n = 22 ) .


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 ( 4.9 0.5 kPa ) , ( mean standard deviation ) than in the control group ( 5.2 0.7 kPa ) ( P = 0.025 ) .


Post-preoxygenation PaO2 did not differ between the groups , but post-intubation PaO2 was significantly higher in the CPAP/PSV group ( 32.2 4.1 kPa ) than in the control group ( 23.8 8.8 kPa ) ( P < 0.001 ) .


In the control group , nadir oxygen saturation was lower ( median 98 % , range 83-99 % ) than in the CPAP/PSV group ( median 99 % , range 97-99 % , P = 0.011 ) .


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 2.8 times higher in EC than in RF group ( p = 0.041 ) and 5 times higher in patients older than 66 years of age ( p = 0.002 ) .


Extent of endothelial damage ( graded from 0 to 3 ) was significantly higher in EC group ( p = 0.03 ) .


Also , in EC group , in patients older than 66 years of age higher proportion of extent of endothelial damage was found ( p = 0.027 ) .


The endothelial damage was more often in EC than in RF group as in the patients older than 66 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 0.1 mg of imidafenacin twice daily ( group A ) or propiverine 20 mg once daily ( group B ) for 12-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 12 .


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 12 .


Quality of life and safety profiles were also compared .


Of 162 patients randomised , 140 completed the study protocol .


The per cent change of weekly UUI episodes at week 12 was -69.1 % in group A and -70.4 % in group B ( both p < 0.0001 ) .


The lower limit of 95 % one-sided confidence interval of the difference between the groups was above the non-inferiority margin ( -19.42 % ) .


Other voiding parameters and quality of life significantly improved at week 12 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 : 28.4 % vs. B : 30.4 % , p = 0.783 ) , the severity of dry mouth was significantly less in the group A than B ( p = 0.042 ) There were no significant differences in other safety profiles .


After the 12-week treatment of imidafenacin 0.1 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 : 1 ) are at risk of developing unilateral CP due to a known neonatal event affecting the brain or 2 ) have been referred to Astrid Lindgren Children 's Hospital due to asymmetric hand function .


The inclusion criteria are age 3-8 months and established asymmetric hand use .


Infants in both groups will receive two 6-weeks training periods separated by a 6-week pause , for 12 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 .


SFO-V4072 / 2012 , 05/22/2013 .


CRTH2 is a G-protein-coupled receptor on T helper2 cells that mediates pro-inflammatory effects of prostaglandin D2 in allergic responses .


To investigate the tolerability and pharmacokinetics of setipiprant ( ACT-129968 ) , a selective orally active CRTH2 antagonist , in allergic asthmatics and to assess the protective effects of multiple doses of this drug against allergen-induced airway responses .


In this 3-centre , double-blinded , placebo-controlled , cross-over study , 18 allergic asthmatic males were randomized to setipiprant 1000 mg or matching placebo b.i.d. for 5 consecutive days .


Study periods were separated by a washout of 3 weeks .


On study day 4 , subjects underwent a standardized allergen challenge and airway response was recorded by FEV1 until 10 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 ( 3-10 h ) ) by on average 25.6 % ( P = 0.006 ) and significantly protected against the allergen-induced airway hyperresponsiveness ( AHR ) to methacholine ( P = 0.0029 ) .


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 CRTH2 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 ( 29.8 2.4 kg/m2 ) were assigned to the groups : control ( CT , n = 24 ) ; conventional peanuts ( CVP , n = 23 ) ; high-oleic peanuts ( HOP , n = 24 ) .


Subjects consumed 56 g of peanuts ( CVP and HOP ) or control biscuits ( CT ) after overnight fasting .


Thereafter , energy metabolism was evaluated over 200 minutes , during which diet-induced thermogenesis ( DIT ) and substrate oxidation were analyzed .


Appetite sensation was recorded for 3 hours .


Statistical analyses were performed using the SAS software considering 5 % 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 100 indicating incomplete compensation .


CT and CVP showed a complete caloric compensation ( scores > 100 ) .


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


After 3 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 2.5 mg and atropine 1.2 mg , intervention group received neostigmine 2.5 mg , glycopyrrolate 0.2 mg and atropine 0.6 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 1 , 3 , 5 , and 7 minutes after injection .


We also recorded heart rate in the PA CU at 0 , 15 , 30 , 45 , and 60 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 = 0.496 ) .


No incidence of significant arrhythmia in both groups .


There is no significant different increase in heart rate in 0.2 mg glycopyrrolate plus 0.6 mg atropine group compared to 1.2 mg atropine alone for antagonizing muscarinic effects of 2.5 mg neostigmine .


Therefore , atropine 0.6 mg and glycopyrrolate 0.2 mg is an alternative to antagonize muscarinic effects of neostigmine .


Increased DNA methylation of the metabolic regulator peroxisome proliferator-activated receptor gamma coactivator 1 alpha ( PPARGC1A ) has been reported in skeletal muscle from type 2 diabetes ( T2D ) subjects and from low birth weight ( LBW ) subjects with an increased risk of T2D .


High-fat overfeeding increases PPARGC1A DNA methylation in muscle in a birth weight dependent manner .


However , PPARGC1A DNA methylation in subcutaneous adipose tissue ( SAT ) in LBW subjects has not previously been investigated .


Our objective was to determine PPARGC1A 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 26 NBW controls were studied after both a 5-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 PPARGC1A DNA methylation was observed in LBW subjects but not in NBW controls .


Basal SAT PPARGC1A mRNA expression was unaffected by diet and similar in the two groups .


However , LBW subjects showed an increased SAT PPARGC1A mRNA expression during insulin-stimulation .


SAT PPARGC1A methylation correlated inversely with mRNA expression during insulin-stimulation .


The study adds to the increasing awareness of PPARGC1A 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 PPARGC1A DNA methylation in insulin resistance and developmental programming of T2D .


The aim of the study was to compare the effects of 2 strategies of antiplatelet treatment ( i.e. , 150 mg ASA vs. 75 mg clpoidogrel ) on plasma level of inflammatory markers in type 2 diabetes mellitus ( T2DM ) patients with high platelet reactivity ( HPR ) .


Study cohort consisted of 304 T2DM patients on chronic ASA therapy ( 75 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 ) -100 collagene/epinephrine closure time ( CEPI-CT ) < 193 s ( n = 80 ) were randomized to 150 mg of ASA or 75 mg of clopidogrel in 2:3 ratio , respectively .


Concentrations of the selected inflammatory markers , including tumor necrosis factor ( TNF ) - , interleukin ( IL ) -6 , solubleCD40 ligand ( sCD40L ) , and high sensitivity C-reactive protein ( hsCRP ) , were measured and compared in both treatment groups before and after 8 weeks of treatment in both groups .


Out of 234 patients included into final analysis , the total of 34.2 % ( n = 80 ) patients displayed HPR , of which 14.1 % ( n = 33 ) were randomized into 150 mg of ASA group and 20.1 % ( n = 47 ) into 75 mg of clopidogrel group .


Treatment with clopidogrel was a positive predictor ( stepwise multiple regression analysis ) of reduction of sCD40L concentration ( odds ratio [ OR ] 4.15 ; p = 0.013 ) , while treatment with 150 mg ASA was a positive predictor of reduction of IL-6 concentration ( OR 4.38 ; p = 0.033 ) .


There was no statistically significant differences between clopidogrel and ASA 150 mg treatment in respect to predictive value for decreased hsCRP concentrations or increased TNF - concentrations .


Increasing the dose of ASA from 75 mg to 150 mg daily or switching ASA 75 mg to clopidogrel 75 mg daily may reduce concentrations of some inflammatory markers ( in particular hsCRP , IL-6 and CD40L ) in T2DM patients with HPR treated previously with 75 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 45-75 years ) who were overweight or obese ( n = 37 ) .


They were randomly divided into 2 groups : a group with a NCD and exercise , and a group with a LCD with exercise .


Of all 37 participants , 30 completed the treatment .


Weight assessment parameters , including changes in weight and body composition and blood sample tests , were performed before and 3 months after intervention .


All parameters decreased significantly in both groups .


Elevation in high-density lipoprotein ( HDL ) cholesterol levels ( P < 0.001 ) was different between the 2 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 1 year after surgery using a standardized nutrient drink test .


We evaluated if pre-surgery satiation could predict satiation and weight loss ( % ) 1 year after surgery using multiple regression modeling .


Descriptive statistics are given as mean SD .


Fourteen women ( 48 9 years old , BMI 41 3 kg/m ( 2 ) ) were evaluated before and 11 2.6 months after surgery ( seven LRYGB , seven LSG ) .


Caloric intake capacity diminished after surgery ( -950 85 kcal on average [ 70 8 % decrease over basal intake capacity ] ; p = 0.002 ) and similarly in both LRYGB ( 727 % decrease ) and LSG groups ( 688 % decrease ) ; p = 0.5 .


There was a significant weight reduction after surgery ( -32 10 kg [ 30 8 % of total basal weight ] ) with a mean post-surgery BMI of 292 kg/m ( 2 ) .


The best predictive model of weight loss ( % ) after surgery ( R ( 2 ) = 89 % , p = 0.0009 ) included : BMI ( p = 0.0004 ) , surgery type ( p = 0.01 ) and pre-surgery intake capacity ( p = 0.006 ) .


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 , 10th Revision ) were randomly assigned to a yoga or a control group .


November 2012-April 2013 at Yamanashi Prefectural Kita Hospital , Japan .


In the yoga group , patients received weekly 1-hour Hatha yoga sessions , in addition to regular treatment , for 8 weeks .


Those in the control group underwent regular treatment , which included a daycare rehabilitation program .


Assessments included the 25-item Resilience Scale ( RS ) , Positive and Negative Syndrome Scale ( PANSS ) , plasma and salivary BDNF level , and SAA activity .


Fifty patients participated ( 25 in each group ; mean agestandard deviation , 50.911.3 years ; mean duration of illness , 25.010.3 years ; mean total PANSS score , 78.217.3 ) .


No significant differences in changes in any variable from baseline to week 8 were found between the two groups ( changes in the yoga group versus the control group : RS score , -1.619.9 versus 0.317.2 ; PANSS score , 0.512.0 versus 5.015.6 ; plasma BDNF , 41.6377.0 pg/dl versus 73.4346.0 pg/dl ; SAA , -26.272.6 kU/l versus -13.868.0 kU/l , respectively ) .


Adjunct yoga therapy showed no positive changes in resilience level or stress markers .


Duration and intensity of yoga sessions and the focus on patients with chronic illness may explain the negative observations in light of past positive evidence regarding yoga therapy .


The purpose of this study was to determine the impact of psychotherapy on cognitive functioning in older adults with late-life depression ( LLD ) and executive dysfunction .


Two hundred twenty-one adults aged 60 years and older participated in a randomized clinical trial comparing the efficacy of Problem Solving Therapy ( PST ) and Supportive Therapy ( ST ) for LLD .


Cognitive performance on seven tests of executive functioning , verbal learning , and memory was evaluated at baseline , after 12 weeks of treatment , and at 24 weeks after the completion of treatment .


Performance on a measure of executive functioning with a significant information processing speed component ( Stroop Color and Word Test ) improved after treatment , F ( 1 , 312 ) = 8.50 , p = 0.002 , and improved performance was associated with a reduction in depressive symptoms but not treatment type .


Performance on other measures of executive functioning , verbal learning , and memory did not change significantly after 12 weeks of psychotherapy treatment .


Our results suggest that improvements in cognitive functioning after psychotherapy treatment for depression in older adults with executive dysfunction are likely focal and not distributed across all cognitive domains .


Although previous analyses reported that PST was superior to ST in the treatment of depression , this analysis indicated no difference between the two treatments with regard to improvements in cognitive functioning .


To determine whether exposure to a peer-led intervention focused on colorectal cancer ( CRC ) screening , physical activity , and multi-vitamin intake can lead to increased intentions to be screened for CRC once age eligible among adults under the age of 50 .


Participants were residents of low-income housing sites , and CRC screening intentions were assessed at baseline and at follow-up ( approximately 2 years later ) to determine changes in screening intentions and factors associated with changes in intentions .


Participants ( n = 692 ) were 78.4 % female , 42.6 % Hispanic and 50.8 % black .


At follow-up , 51 % maintained their intention to be screened and 14.6 % newly intended to get screened .


Individuals newly intending to get screened were more likely to have participated in the intervention , be older , male , and born in Puerto Rico or the United States compared to those who maintained their intention not to get screened ( p < 0.05 ) .


Exposure to CRC prevention messages before the age of 50 can increase screening intentions among individuals who did not initially intend to get screened .


Peer-led interventions to promote CRC screening should include individual less than 50 years of age , as this may contribute to increased screening at the recommended age threshold .


Men who have sex with men ( MSM ) often face socially sanctioned disapproval of sexual deviance from the heterosexual `` normal . ''


Such sexual stigma can be internalized producing a painful affective state ( i.e. , shame ) .


Although shame ( e.g. , addiction ) can predict risk-taking ( e.g. , alcohol abuse ) , sexual shame 's link to sexual risk-taking is unclear .


Socially Optimized Learning in Virtual Environments ( SOLVE ) was designed to reduce MSM 's sexual shame , but whether it does so , and if that reduction predicts HIV risk reduction , is unclear .


To test if at baseline , MSM 's reported past unprotected anal intercourse ( UAI ) is related to shame ; MSM 's exposure to SOLVE compared to a wait-list control ( WLC ) condition reduces MSM 's shame ; and shame-reduction mediates the link between WLC condition and UAI risk reduction .


HIV-negative , self-identified African American , Latino or White MSM , aged 18-24 years , who had had UAI with a non-primary/casual partner in the past three months were recruited for a national online study .


Eligible MSM were computer randomized to either WLC or a web-delivered SOLVE .


Retained MSM completed baseline measures ( e.g. , UAI in the past three months ; current level of shame ) and , in the SOLVE group , viewed at least one level of the game .


At the end of the first session , shame was measured again .


MSM completed follow-up UAI measures three months later .


All data from 921 retained MSM ( WLC condition , 484 ; SOLVE condition , 437 ) were analyzed , with missing data multiply imputed .


At baseline , MSM reporting more risky sexual behaviour reported more shame ( r s = 0.21 ; p < 0.001 ) .


MSM in the SOLVE intervention reported more shame reduction ( M = -0.08 ) than MSM in the control condition ( M = 0.07 ; t ( 919 ) = 4.24 ; p < 0.001 ) .


As predicted , the indirect effect was significant ( point estimate -0.10 , 95 % bias-corrected CI [ -0.01 to -0.23 ] such that participants in the SOLVE treatment condition reported greater reductions in shame , which in turn predicted reductions in risky sexual behaviour at follow-up .


The direct effect , however , was not significant .


SOLVE is the first intervention to : ( 1 ) significantly reduce shame for MSM ; and ( 2 ) demonstrate that shame-reduction , due to an intervention , is predictive of risk ( UAI ) reduction over time .


It is unclear whether the effect of video-assisted thoracoscopic surgery ablation is better than catheter ablation on paroxysmal atrial fibrillation ( PAF ) or not .


This study aimed to compare the effects of catheter ablation and video-assisted thoracoscopic surgery ablation on PAF .


From March 2008 to March 2012 , 138 consecutive patients with PAF were randomly assigned to receive either video-assisted thoracoscopic surgery ablation ( thoracoscopy group , n = 66 ) or the traditional catheter ablation ( catheter group , n = 72 ) .


No patient died during the study and all were successfully followed and included in analysis .


There were no significant differences in clinical and echocardiographic characteristics between the two groups .


All patients were evaluated at 1 week , 1 month , 3 months , 6 months , and 12 months after discharge by physical examination and related laboratory tests .


Preoperative left atrium dimensions ( LADs ) of the recurrent AF were ( 47 4 ) mm in the thoracoscopy group and ( 46 8 ) mm in the catheter group , whereas the LADs were ( 40 5 ) and ( 39 9 ) mm , respectively , in non-recurrent PAF .


The short-term outcome of video-assisted thoracoscopic surgery ablation is safe and effective ; and the indications are wider than those for catheter ablation .


The larger left atrium diameter is related to the recurrence of atrial fibrillation .


The objective was to determine if use of ultrasound ( US ) by emergency physicians ( EPs ) to localize spinal landmarks improves the performance of lumbar puncture ( LP ) .


This was a prospective , randomized , controlled study conducted in a county teaching hospital .


Subjects , adults 18years of age or older who were to receive LPs for routine clinical care in the emergency department ( ED ) , were randomized either to undergo US localization of the puncture site or to have the puncture site determined by palpation of spinal landmarks .


Primary outcomes were the number of needle insertion attempts and success of the procedure .


Secondary outcomes were pain associated with the procedure , time to perform the procedure , number of traumatic taps , and patient satisfaction with the procedure .


One-hundred patients were enrolled in the study , with 50 in each study group .


There were no significant differences between the two groups in terms of age , sex , body mass index ( BMI ) , indication for LP , or ease of palpation of landmarks .


For both primary outcomes and secondary outcomes there were no significant differences between those undergoing US localization and those with palpation alone .


These data do not suggest any advantage to the routine use of US localization for LP insertion , although further study may be warranted to look for benefit in the difficult to palpate or obese patient subgroups .


One of the most common joint dislocations presented to the emergency department ( ED ) is anterior shoulder dislocation ( ASD ) .


Various techniques for the treatment of this abnormality have been suggested .


In this study , we evaluated the efficacy and success rate of modified scapular manipulation ( MSM ) as a painless procedure compared to traction-countertraction ( TCT ) for reduction of ASD .


Patients with ASD who were presented to ED of Baqiyatallah Hospital , Tehran during 2011 were included .


They were randomly divided into MSM group or TCT group and then pain at reduction , time of reduction , duration of hospitalization , and success rate were compared .


In TCT group , reduction was performed using sedative and antipain medications .


Ninety seven patients ( 81.6 % male ) with a mean age of 34.15 years13 .48 years were studied .


The reduction time between both groups showed a significant difference ( 470.88 seconds227 .59 seconds for TCT group , 79.35 seconds82 .49 seconds for MSM group , P < 0.001 ) .


The success rate in MSM group in the first and second effort were 89 % and 97 % whereas 73 % and 100 % in the TCT group respectively ( P < 0.001 ) .


It seems that the manipulation technique can be more successful than the TCT method at the first effort whilst the second effort has the opposite results .


Also MSM can be safer , cheaper and more acceptable for patients than TCT as a standard traditional method .


The purpose of this clinical study was to compare the chair time and degree of patient satisfaction after use of the Isolite system ( IS ) versus rubber dam ( RD ) during the application of pit and fissure sealants .


The patients included in this study ranged from seven to 16 years old .


In each subject , pit and fissure sealants were applied to one permanent molar in each quadrant .


IS dental isolation was used on one side ; RD isolation was used on the other side .


Chair time was assessed using a stopwatch , and patient acceptance was evaluated using a questionnaire .


Forty-two subjects ( 23 females and 19 males ) were enrolled in the study .


The average chair time was 19.36 minutes for the application of pit and fissure sealants on the RD side ; average chair time was 10 minutes for the IS side ( P < .001 ) .


Sixty-nine percent of the subjects were more comfortable using IS , while 31 percent found RD to be more comfortable ( P = .02 ) .


Isolite is a viable alternative to the conventional rubber dam .


The use of Isolite is associated with reduced chair time and greater patient satisfaction .


The objective of this study was to determine the Hounsfield unit ( HU ) changes in the alveolar bone and root surfaces during controlled canine retractions .


Eighteen maxillary canine retraction patients were selected for this split-mouth design clinical trial .


The canines in each patient were randomly assigned to receive either translation or controlled tipping treatment .


Pretreatment and posttreatment cone-beam computed tomography scans of each patient were used to determine tooth movement direction and HU changes .


The alveolar bone and root surface were divided into 108 divisions , respectively .


The HUs in each division were measured .


Mixed-model analysis of variance was applied to test the HU change distribution at the P < 0.05 significance level .


The HU changes varied with the directions relative to the canine movement .


The HU reductions occurred at the root surfaces .


Larger reductions occurred in the divisions that were perpendicular to the moving direction .


However , HUs decreased in the alveolar bone in the moving direction .


The highest HU reduction was at the coronal level .


HU reduction occurs on the root surface in the direction perpendicular to tooth movement and in the alveolar bone in the direction of tooth movement when a canine is retracted .


Over fifty percent of stroke patients experience chronic arm hand performance problems , compromising independence in daily life activities and quality of life .


Task-oriented training may improve arm hand performance after stroke , whereby augmented therapy may lead to a better treatment outcome .


Technology-supported training holds opportunities for increasing training intensity .


However , the effects of robot-supported task-oriented training with real life objects in stroke patients are not known to date .


The aim of the present study was to investigate the effectiveness and added value of the Haptic Master robot combined with task-oriented arm hand training in chronic stroke patients .


In a single-blind randomized controlled trial , 22 chronic stroke patients were randomly allocated to receive either task-oriented robot-assisted arm-hand training ( experimental group ) or task-oriented non-robotic arm-hand training ( control group ) .


For training , the T-TOAT ( Technology-supported Task-Oriented Arm Training ) method was applied .


Training was provided during 8 weeks , 4 times/week , 2 30 min/day .


A significant improvement after training on the Action Research Arm Test ( ARAT ) was demonstrated in the experimental group ( p = 0.008 ) .


Results were maintained until 6 months after cessation of the training .


On the perceived performance measure ( Motor Activity Log ( MAL ) ) , both , the experimental and control group improved significantly after training ( control group p = 0.008 ; experimental group p = 0.013 ) .


The improvements on MAL in both groups were maintained until 6 months after cessation of the training .


With regard to quality of life , only in the control group a significant improvement after training was found ( EuroQol-5D p = 0.015 , SF-36 physical p = 0.01 ) .


However , the improvement on SF-36 in the control group was not maintained ( p = 0.012 ) .


No between-group differences could be demonstrated on any of the outcome measures .


Arm hand performance improved in chronic stroke patients , after eight weeks of task oriented training .


The use of a Haptic Master robot in support of task-oriented arm training did not show additional value over the video-instructed task-oriented exercises in highly functional stroke patients .


Current Controlled Trials ISRCTN82787126 .


To compare the clinical and radiological outcomes of two implant designs with different prosthetic interfaces and neck configurations .


Thirty-four partially edentate patients randomly received at least one NobelActive implant ( Nobel Biocare , Gteborg , Sweden ) with back-tapered collar , internal conical connection and platform shifting design , and one NobelSpeedy implant ( Nobel Biocare ) with external hexagon and flat-to-flat implant-abutment interface according to a split-mouth design .


Follow-up continued to 3 years post-loading .


The primary outcome measures were the success rates of the implants and prostheses , and the occurrence of any surgical and prosthetic complications during the entire follow-up .


Secondary outcome measures were : horizontal and vertical peri-implant marginal bone level ( MBL ) changes , resonance frequency analysis values at implant placement and loading ( 4 months ) , sulcus bleeding index ( SBI ) and plaque score ( PS ) .


No drop-out occurred .


No implants and prostheses failures were observed to the 3-year follow-up .


MBL changes were statistically significant different with better results for the NobelActive implants for both horizontal and vertical measurements ( P = 0.000 ) .


After 3 years post-loading , the NobelActive implants underwent a mean vertical bone resorption of 0.66 mm , compared with 1.25 mm for the NobelSpeedy Groovy implants ( P = 0.000 ) ; the mean horizontal bone resorption was 0.19 mm for the NobelActive implants and 0.60 mm for the NobelSpeedy Groovy implants ( P = 0.000 ) .


A high ISQ value was found for both implants , and no statistically significant difference was found for ISQ mean values between interventions ( P = 0.941 at baseline ; P = 0.454 at implantabutment connection ; P = 0.120 at prosthesis delivery ) .


All implants showed good periodontal health at the 3-year-in-function visit , with no significant differences between groups .


The results of this research suggest that in well-maintained patients , the MBL changes could be affected by the different implant design .


After 4 months of unloaded healing , as well as after 3 years in function , both implants provided good results , however vertical and horizontal bone loss had statistically significant differences between the two groups ( difference of 0.58 0.10 mm for the vertical MBL , and 0.4 0.05 mm for the horizontal MBL ) , with lower values in the Nobel Active implants , compared to the NobelSpeedy Groovy implants .


Unopposed estrogen has a central role in development of endometrial benign , premalignant and malignant lesions .


The aim of this study was to evaluate the anti-estrogenic effect of metformin on endometrial histology in comparison with progesterone .


A total of 43 patients who were referred to our center for abnormal uterine bleeding and had a histologic diagnosis were disordered proliferative endometrium or simple endometrial hyperplasia were included and randomly distributed in two groups treated with metformin ( 500mg Bid ) or megestrol ( 40mg daily ) , respectively , for three months .


After this period the patients were evaluated by another endometrial biopsy to assess the impact of the two drugs in restoring normal endometrial histology .


Our findings revealed that metformin could induce endometrial atrophy in 21 out of 22 patients ( 95.5 % ) while this positive response was achieved in only 13 out of 21 patients ( 61.9 % ) in the megstrol group .


In addition two low grade endometrial carcinomas in the metformin group responded very well .


We conclude that metformin could be used as an effective antiestrogenic agent in control of abnormal endometrial proliferative disorders .


Thiazolidinediones are associated with increased fractures in type 2 diabetes mellitus ( T2D ) .


One explanation is that activation of peroxisome proliferator-activated receptor - expression alters bone remodeling cells .


To investigate whether osteoclast and osteogenic precursor cells are altered by rosiglitazone ( RSG ) treatment in T2D as compared to metformin ( MET ) treatment .


A randomized controlled trial of RSG or MET for 52 weeks , followed by 24 weeks of MET .


Data were generated at a tertiary care center .


Seventy-three T2D postmenopausal women participated .


Peripheral blood mononuclear cells were isolated and cultured with receptor activator of nuclear factor B ligand and stained for tartrate-resistant acid phosphatase to measure circulating osteoclast precursors .


Peripheral blood mononuclear cells were also characterized for osteogenic , endothelial , and calcification markers by flow cytometry with the ligands osteocalcin ( OCN ) , CD34 , and CD 146 .


Tartrate-resistant acid phosphatase-positive cells increased between weeks 0 and 52 ( RSG , 2.9 2 to 14.0 3 U/L , P = .001 ; MET , 3.3 2 to 16.7 2 U/L , P = .001 ) , increasing further in the RSG group after changing to MET ( to 26.5 5 U/L , P = .05 vs wk 52 ) .


With RSG , OCN + cells with CD34 but without CD146 fell from weeks 0 to 52 ( 20.1 1 % to 15.5 2 % ; P = .03 ) , remaining stable through week 76 .


The OCN + cells lacking both CD34 and CD146 increased from weeks 0 to 52 ( 67.3 2 to 74.4 2 % ; P = .02 ) , but returned to baseline after switching to MET .


In postmenopausal women with T2D , circulating osteoclast precursor cells increase with both RSG and MET , and increase further when switching from RSG to MET .


Subpopulations of cells that may be involved in the osteogenic lineage pathway are also altered with RSG .


Further work is necessary to elucidate how these changes may relate to fracture risk .


This study was designed to assess the knowledge acquired by very young children ( < 6 years ) trained by their own teachers at nursery school .


This comparative study assessed the effect of training before the age of 6 years compared with a group of age-matched untrained children .


Some schoolteachers were trained by emergency medical teams to perform basic first aid .


Eighteen classes comprising 315 pupils were randomly selected : nine classes of trained pupils ( cohort C1 ) and nine classes of untrained pupils ( cohort C2 ) .


The test involved observing and describing three pictures and using the phone to call the medical emergency centre .


Assessment of each child was based on nine criteria , and was performed by the teacher 2 months after completion of first aid training .


This study concerned 285 pupils : 140 trained and 145 untrained .


The majority of trained pupils gave the expected answers for all criteria and reacted appropriately by assessing the situation and alerting emergency services ( 55.7-89 .3 % according to the questions ) .


Comparison of the two groups revealed a significantly greater ability of trained pupils to describe an emergency situation ( p < 0.005 ) and raise the alert ( p < 0.0001 ) .


This study shows the ability of very young children to assimilate basic skills as taught by their own schoolteachers .


Existing studies of risk factors for physical impairments in acute lung injury ( ALI ) survivors were potentially limited by single-center design or relatively small sample size .


To evaluate risk factors for three measures of physical impairments commonly experienced by survivors of ALI in the first year after hospitalization .


A prospective , longitudinal study of 6 - and 12-month physical outcomes ( muscle strength , 6-minute-walk distance , and Short Form [ SF ] -36 Physical Function score ) for 203 survivors of ALI enrolled from 12 hospitals participating in the ARDS Network randomized trials .


Multivariable regression analyses evaluated the independent association of critical illness-related variables and intensive care interventions with impairments in each physical outcome measure , after adjusting for patient demographics , comorbidities , and baseline functional status .


At 6 and 12 months , respectively , mean ( SD ) values for strength ( presented as proportion of maximum strength score evaluated using manual muscle testing ) was 92 % ( 8 % ) and 93 % ( 9 % ) , 6-minute-walk distance ( as percent-predicted ) was 64 % ( 22 % ) and 67 % ( 26 % ) , and SF-36 Physical Function score ( as percent-predicted ) was 61 % ( 36 % ) and 67 % ( 37 % ) .


After accounting for patient baseline status , there was significant association and statistical interaction of mean daily dose of corticosteroids and intensive care unit length of stay with impairments in physical outcomes .


Patients had substantial impairments , from predicted values , for 6-minute-walk distance and SF-36 Physical Function outcome measures .


Minimizing corticosteroid dose and implementing existing evidence-based methods to reduce duration of intensive care unit stay and associated patient immobilization may be important interventions for improving ALI survivors ' physical outcomes .


Aortic valve stenosis is one of the most common heart diseases in older patients .


Nowadays , surgical aortic valve replacement is the ` gold standard ' treatment for this pathology and the most implanted prostheses are biological ones .


The three most implanted bovine bioprostheses are the Trifecta valve ( St. Jude Medical , Minneapolis , MN , USA ) , the Mitroflow valve ( Sorin Group , Saluggia , Italy ) , and the Carpentier-Edwards Magna Ease valve ( Edwards Lifesciences , Irvine , CA , USA ) .


We propose a randomized trial to objectively assess the hemodynamic performances of these bioprostheses .


First , we will measure the aortic annulus diameter using CT-scan , echocardiography and by direct sizing in the operating room after native aortic valve resection .


The accuracy of information , in terms of size and spatial dimensions of each bioprosthesis provided by manufacturers , will be checked .


Their hemodynamic performances will be assessed postoperatively at the seventh day and the sixth month after surgery .


This prospective controlled randomized trial aims to verify and compare the hemodynamic performances and the sizing of these three bioprostheses .


The data obtained may help surgeons to choose the best suitable bioprosthesis according to each patient 's morphological characteristics .


ClinicalTrials.gov Identifier : NCT01522352 .


Polio eradication efforts have been hampered by low responses to trivalent oral poliovirus vaccine ( tOPV ) in some developing countries .


Since stomach acidity may neutralize vaccine viruses , we assessed whether administration of a buffer solution could improve the immunogenicity of tOPV .


Healthy infants 4-6 weeks old in Sylhet , Bangladesh , were randomized to receive tOPV with or without a sodium bicarbonate and sodium citrate buffer at age 6 , 10 , and 14 weeks .


Levels of serum neutralizing antibodies for poliovirus types 1 , 2 , and 3 were measured before and after vaccination , at 6 and 18 weeks of age , respectively .


Serologic response rates following 3 doses of tOPV for buffer recipients and control infants were 95 % and 88 % ( P = .065 ) , respectively , for type 1 poliovirus ; 95 % and 97 % ( P = .543 ) , respectively , for type 2 poliovirus ; and 90 % and 89 % ( P = .79 ) , respectively , for type 3 poliovirus .


Administration of a buffer solution prior to vaccination was not associated with statistically significant increases in the immune response to tOPV ; however , a marginal 7 % increase ( P = .065 ) in serologic response to poliovirus type 1 was observed .


NCT01579825 .


Data on the effect of initial combination therapy with ambrisentan and tadalafil on long-term outcomes in patients with pulmonary arterial hypertension are scarce .


In this event-driven , double-blind study , we randomly assigned , in a 2:1:1 ratio , participants with World Health Organization functional class II or III symptoms of pulmonary arterial hypertension who had not previously received treatment to receive initial combination therapy with 10 mg of ambrisentan plus 40 mg of tadalafil ( combination-therapy group ) , 10 mg of ambrisentan plus placebo ( ambrisentan-monotherapy group ) , or 40 mg of tadalafil plus placebo ( tadalafil-monotherapy group ) , all administered once daily .


The primary end point in a time-to-event analysis was the first event of clinical failure , which was defined as the first occurrence of a composite of death , hospitalization for worsening pulmonary arterial hypertension , disease progression , or unsatisfactory long-term clinical response .


The primary analysis included 500 participants ; 253 were assigned to the combination-therapy group , 126 to the ambrisentan-monotherapy group , and 121 to the tadalafil-monotherapy group .


A primary end-point event occurred in 18 % , 34 % , and 28 % of the participants in these groups , respectively , and in 31 % of the pooled-monotherapy group ( the two monotherapy groups combined ) .


The hazard ratio for the primary end point in the combination-therapy group versus the pooled-monotherapy group was 0.50 ( 95 % confidence interval [ CI ] , 0.35 to 0.72 ; P < 0.001 ) .


At week 24 , the combination-therapy group had greater reductions from baseline in N-terminal pro-brain natriuretic peptide levels than did the pooled-monotherapy group ( mean change , -67.2 % vs. -50.4 % ; P < 0.001 ) , as well as a higher percentage of patients with a satisfactory clinical response ( 39 % vs. 29 % ; odds ratio , 1.56 [ 95 % CI , 1.05 to 2.32 ] ; P = 0.03 ) and a greater improvement in the 6-minute walk distance ( median change from baseline , 48.98 m vs. 23.80 m ; P < 0.001 ) .


The adverse events that occurred more frequently in the combination-therapy group than in either monotherapy group included peripheral edema , headache , nasal congestion , and anemia .


Among participants with pulmonary arterial hypertension who had not received previous treatment , initial combination therapy with ambrisentan and tadalafil resulted in a significantly lower risk of clinical-failure events than the risk with ambrisentan or tadalafil monotherapy .


( Funded by Gilead Sciences and GlaxoSmithKline ; AMBITION ClinicalTrials.gov number , NCT01178073 . )


With the rise in the ageing population and absence of a cure for dementia , cost-effective prevention strategies for those ` at risk ' of dementia including those with depression and/or mild cognitive impairment are urgently required .


This study evaluated the efficacy of a multifaceted Healthy Brain Ageing Cognitive Training ( HBA-CT ) program for older adults ` at risk ' of dementia .


Using a single-blinded design , 64 participants ( mean age = 66.5 years , SD = 8.6 ) were randomized to an immediate treatment ( HBA-CT ) or treatment-as-usual control arm .


The HBA-CT intervention was conducted twice-weekly for seven weeks and comprised group-based psychoeducation about cognitive strategies and modifiable lifestyle factors pertaining to healthy brain ageing , and computerized cognitive training .


In comparison to the treatment-as-usual control arm , the HBA-CT program was associated with improvements in verbal memory ( p = 0.03 ) , self-reported memory ( p = 0.03 ) , mood ( p = 0.01 ) , and sleep ( p = 0.01 ) .


While the improvements in memory ( p = 0.03 ) and sleep ( p = 0.02 ) remained after controlling for improvements in mood , only a trend in verbal memory improvement was apparent after controlling for sleep .


The HBA-CT program improves cognitive , mood , and sleep functions in older adults ` at risk ' of dementia , and therefore offers promise as a secondary prevention strategy .


A recombinant cysteine proteinase from Leishmania ( Leishmania ) infantum chagasi ( rLdccys1 ) was previously shown to induce protective immune responses against murine and canine visceral leishmaniasis .


These findings encouraged us to use rLdccys1 in the immunotherapy of naturally infected dogs from Teresina , Piau , a region of high incidence of visceral leishmaniasis in Brazil .


Thirty naturally infected mongrel dogs displaying clinical signs of visceral leishmaniasis were randomly divided in three groups : one group received three doses of rLdccys1 in combination with the adjuvant Propionibacterium acnes at one month interval between each dose ; a second group received three doses of P. acnes alone ; a third group received saline .


The main findings were : 1 ) dogs that received rLdccys1 with P. acnes did not display increase of the following clinical signs : weight loss , alopecia , onychogryphosis , cachexia , anorexia , apathy , skin lesions , hyperkeratosis , ocular secretion , and enlarged lymph nodes ; they also exhibited a significant reduction in the spleen parasite load in comparison to the control dogs ; 2 ) rLdccys1-treated dogs exhibited a significant delayed type cutaneous hypersensitivity elicited by the recombinant antigen , as well as high IgG2 serum titers and low IgG1 serum titers ; sera from rLdccys1-treated dogs also contained high IFN - and low IL-10 concentrations ; 3 ) control dogs exhibited all of the clinical signs of visceral leishmaniasis and had low serum IgG2 and IFN - levels and high concentrations of IgG1 and IL-10 ; 4 ) all of the dogs treated with rLdccys1 were alive 12 months after treatment , whereas dogs which received either saline or P. acnes alone died within 3 to 7 months .


These findings illustrate the potential use of rLdccys1 as an additional tool for the immunotherapy of canine visceral leishmaniasis and support further studies designed to improve the efficacy of this recombinant antigen for the treatment of this neglected disease .


To evaluate the safety and immunogenicity of the thiomersal-free ( TF ) and thiomersal-containing ( TC ) formulations of Hepavax-Gene in healthy Vietnamese neonates .


A single-blind , randomized , controlled study in Ho Chi Minh City , Vietnam .


Healthy infants , born after a normal gestational period ( 37-42 weeks ) to hepatitis B surface antigen-negative mothers , participated in the study .


Subjects were randomly allocated in a 1:1 ratio to receive either Hepavax-Gene TC or Hepavax-Gene TF using a standard 0-1-6-month administration schedule .


Postvaccination blood samples were taken at months 1 , 6 and 7 .


Parents/legal guardians recorded solicited local and systemic adverse events up to 4 weeks after each vaccination .


Very high proportions of subjects were seroprotected .


Seroprotection rates at 1 , 6 and 7 months were all above 95 % using a 10 IU/L cutoff , and were mostly above 90 % using a 100 IU/L cutoff .


Seroprotection rates between the 2 formulations were equivalent within a 5 % margin for either cutoff titer both after 6 and 7 months .


There were no significant differences in the number of adverse events reported between the 2 formulations .


Safety results were in line with previous reports for Hepavax-Gene .


Both formulations of Hepavax-Gene were well tolerated .


There were no local adverse events reported in the TF group .


No serious adverse events were reported during the study .


The thiomersal-free formulation of Hepavax-Gene was noninferior to the thiomersal-containing formulation of Hepavax-Gene in terms of immunogenicity .


There was evidence that the thiomersal-free vaccine was associated with fewer local adverse events .


To investigate the dynamics of lipid metabolism , C-reactive protein ( CRP ) , lipid peroxidation and antioxidant system in lacunar infarction ( LI ) in chronic cerebral ischemia .


Two groups of patients were studied .


The main group included 31 patients who received intravenous laser irradiation of blood ( ILIB ) with semiconductor laser ( wavelength - 0.67 microns , the power output - 3-2 mW ) in addition to standard treatment .


Patients of the control group ( n = 22 ) received only standard treatment .


A statistically significant decrease in total cholesterol levels to normal values due to the significant reduction of the content of antiatherogenic fraction of cholesterol ( high-density lipoprotein and atherogenic low-density lipoprotein cholesterol ) was found in the main group after treatment .


The reduction in atherogenic cholesterol fractions in both groups was associated with the decrease in apolipoprotein B level .


The level of CRP was higher than normal in the main and control groups of patients before and after treatment , which indicated the risk of vascular diseases in patients with LI .


After treatment , superoxide dismutase activity returned to normal values .


In patients of the main group , the catalase activity increased while the level of reduced glutathione did not change and lipid peroxidation products remained on the high level .


Additional antioxidant therapy is needed for these patients .


Clinical trials have shown the effectiveness of systemic and local insulin therapy in improving wound healing .


Diabetic wounds remain a challenge for healthcare providers .


Impaired angiogenesis and reduced granulation tissue formation contribute to inadequate wound healing .


The aim of this study was to investigate the effect of local insulin administration in acute and chronic diabetic wounds .


Eight diabetic patients presenting with full-thickness wounds , of different causes , were included in this study .


Five wounds were due to necrobiosis , one to trauma , and two to postneoplasm resection .


All wounds were treated with regular bedside treatment .


In addition , half of the wound surface was treated with insulin and the other half did not receive insulin .


Thermographic and biopsy specimens of the two sides were obtained on days 0 and 14 .


The presence of fibrosis , change in temperature , and amount of blood were evaluated .


Significant differences in the number of vessels were observed on the insulin-treated side ( 96 47 ) when compared with the no-insulin side ( 32.88 45 ) ( p < 0.026 ) .


The percentage of fibrosis ( insulin : 44.42 30.42 percent versus no insulin : 12.38 36.17 percent ; p < 0.047 ) and the mean temperature ( insulin : 1.27 1.12 C versus no-insulin : 0.13 1.22 C ; p < 0.001 ) were also significantly different between sides .


No adverse events related to the study occurred .


The use of local insulin improves the formation of new blood vessels , increases fibrosis , and correlates with increased temperature .


Therapeutic , II .


The prevalence of peanut allergy among children in Western countries has doubled in the past 10 years , and peanut allergy is becoming apparent in Africa and Asia .


We evaluated strategies of peanut consumption and avoidance to determine which strategy is most effective in preventing the development of peanut allergy in infants at high risk for the allergy .


We randomly assigned 640 infants with severe eczema , egg allergy , or both to consume or avoid peanuts until 60 months of age .


Participants , who were at least 4 months but younger than 11 months of age at randomization , were assigned to separate study cohorts on the basis of preexisting sensitivity to peanut extract , which was determined with the use of a skin-prick test -- one consisting of participants with no measurable wheal after testing and the other consisting of those with a wheal measuring 1 to 4 mm in diameter .


The primary outcome , which was assessed independently in each cohort , was the proportion of participants with peanut allergy at 60 months of age .


Among the 530 infants in the intention-to-treat population who initially had negative results on the skin-prick test , the prevalence of peanut allergy at 60 months of age was 13.7 % in the avoidance group and 1.9 % in the consumption group ( P < 0.001 ) .


Among the 98 participants in the intention-to-treat population who initially had positive test results , the prevalence of peanut allergy was 35.3 % in the avoidance group and 10.6 % in the consumption group ( P = 0.004 ) .


There was no significant between-group difference in the incidence of serious adverse events .


Increases in levels of peanut-specific IgG4 antibody occurred predominantly in the consumption group ; a greater percentage of participants in the avoidance group had elevated titers of peanut-specific IgE antibody .


A larger wheal on the skin-prick test and a lower ratio of peanut-specific IgG4 : IgE were associated with peanut allergy .


The early introduction of peanuts significantly decreased the frequency of the development of peanut allergy among children at high risk for this allergy and modulated immune responses to peanuts .


( Funded by the National Institute of Allergy and Infectious Diseases and others ; ClinicalTrials.gov number , NCT00329784 . )


Health care professionals in several countries are searching for alternatives to acute hospitalization .


In Hallingdal , Norway , selected acute patients are admitted to a community hospital .


The aim of this study was to analyse whether acute admission to a community hospital as an alternative to a general hospital had any positive or negative health consequences for the patients .


Patients intended for acute admission to the local community hospital were asked to join a randomized controlled trial .


One group of the enrolled patients was admitted as planned ( group 1 , n = 33 ) , while another group was admitted to the general hospital ( group 2 , n = 27 ) .


Health outcomes were measured by the Nottingham Extended Activity of Daily Living Questionnaire and by collection of data concerning specialist and community health care services in a follow-up year .


After one year , no statistical significant differences in the level of daily function was found between group 1 ( admissions to the community hospital ) and group 2 ( admissions to the general hospital ) .


Group 1 had recorded fewer in-patient days at hospitals and nursing homes , as well as lower use of home nursing , than group 2 .


For outpatient referrals , the trend was the opposite .


However , the differences between the two groups were not at a 5 % level of statistical significance .


No statistical significant differences at a 5 % level were found related to health consequences between the two randomized groups .


The study however , indicates a consistent trend of health benefits rather than risk from acute admissions to a community hospital , as compared to the general hospital .


Emergency admission and treatment at a lower-level facility than the hospital thus appears to be a feasible solution for a selected group of patients .


ClinicalTrials.gov NCT01069107 .


Registered 2 April 2010 .


Obesity in pregnancy is associated with fetal macrosomia , a raised neonatal fat mass and an increased risk of obesity and poor metabolic health in childhood which persists into adulthood .


The offspring of obese women are more likely to be obese than the offspring of lean women when they become pregnant themselves , perpetuating a cycle of obesity and its associated negative metabolic consequences .


Increasing physical activity during pregnancy could improve insulin sensitivity and reduce the risk of maternal and offspring adverse outcomes .


The UK Pregnancy Better Eating and Activity Trial ( UPBEAT ) is a trial of a complex intervention designed to improve pregnancy outcomes through dietary changes and physical activity .


Data from the pilot trial of 183 women were available for analysis .


The relationship between the time spent at different physical activity levels and maternal and infant pregnancy outcomes was examined .


Strong evidence exists that physical activity improves insulin sensitivity in non-pregnant populations , and lifestyle interventions of proven effectiveness in non-pregnant populations have been developed .


Women who are active in pregnancy demonstrate better glucose control and favourable pregnancy outcomes .


There is a lack of effective interventions to support obese pregnant women to be physically active .


No difference was detected in objectively measured physical activity between women randomised to the intervention and control arms of the UPBEAT pilot trial .


Light-intensity physical activity was lower in early pregnancy in women who delivered macrosomic infants .


Maternal sedentary time at 35-36 weeks ' gestation was positively associated and moderate-intensity physical activity was inversely associated with neonatal abdominal circumference .


Maternal physical activity is associated with infant birth weight and abdominal circumference and is an appropriate target for intervention to improve infant outcomes .


The challenge remains to develop an effective intervention to support obese pregnant women to be physically active .


In type 2 diabetes mellitus , fixed-dose combination ( FDC ) can provide the complementary benefits of correction of multiple pathophysiologic defects such as dysfunctions in glycemic or metabolic control while improving compliance compared with separate tablets taken together .


The objective of the study reported here was to compare the pharmacodynamic ( PD ) , pharmacokinetic ( PK ) , and tolerability profiles of gemigliptin and extended-release metformin ( metformin XR ) between FDC and separate tablets .


A randomized , open-label , single-dose , two-way , two-period , crossover study was conducted in 28 healthy male volunteers .


Two FDC tablets of gemigliptin/metformin 25/500 mg or separate tablets of gemigliptin ( 50 mg 1 ) and metformin XR ( 500 mg 2 ) were orally administered in each period .


Serial blood samples were collected up to 48 hours post-dose to determine dipeptidyl peptidase 4 ( DPP-4 ) activity using spectrophotometric assay and concentrations of gemigliptin and metformin using tandem mass spectrometry .


Geometric mean ratios ( GMRs ) of FDC to separate tablet formulations and their 90 % confidence intervals ( CIs ) were calculated to compare the PD and PK parameters between the two formulations .


Tolerability was assessed throughout the study .


The plasma DPP-4 activity-time curves of the FDC and the separate tablets almost overlapped , leading to a GMR ( 90 % CI ) of the FDC to separate tablets for the plasma DPP-4 activity and its maximum inhibition of 1.00 ( 0.97-1 .04 ) and 0.92 ( 0.82-1 .05 ) , respectively .


Likewise , all of the GMRs ( 90 % CIs ) of FDC to separate tablets for the area under the plasma concentration-time curve and maximum plasma concentration of gemigliptin and metformin fell entirely within the conventional bioequivalence range of 0.80-1 .25 .


Both the FDC and separate tablets were well tolerated .


The PD , PK , and tolerability profiles of gemigliptin and metformin XR in FDC and separate tablets were found to be comparable .


The FDC tablet of gemigliptin and metformin sustained release can be a convenient therapeutic option in patients with type 2 diabetes mellitus requiring a combination approach .


To compare the mean hospital discharge times and perioperative outcomes for radiofrequency volumetric thermal ablation ( RFVTA ) of fibroids and laparoscopic myomectomy ( LM ) .


The present postmarket , randomized , prospective , single-center , longitudinal , comparative study , conducted in Tbingen , Germany , evaluated the outcomes of RFVTA and the current standard of care ( LM ) for symptomatic uterine fibroids in women who desired uterine conservation .


The surgeons were blinded to the treatment until all fibroids had been mapped by laparoscopic ultrasound .


The mean hospitalization times were 10.0 5.5 ( median 7.8 [ range 4.2-25 .5 ] ) hours for the RFVTA group and 29.9 14.2 ( median 22.6 [ range 16.1-68 .1 ] ) hours for the LM group ( P < 0.001 , Wilcoxon test ) .


Intraoperative blood loss was 16 9 ( median 20 [ range : 0-30 ] ) mL for the RFVTA procedures and 51 57 ( median 35 [ range 10-300 ] ) mL for the LM procedures .


The percentage of fibroids imaged by laparoscopic ultrasound that were treated/excised was 98.6 % for RFVTA and 80.3 % for LM .


Two complications were reported : vertigo ( n = 1 ; RFVTA ) and port site hematoma ( n = 1 ; LM ) .


Radiofrequency volumetric thermal ablation resulted in the treatment of more fibroids , a significantly shorter hospital stay , and less intraoperative blood loss than laparoscopic myomectomy .


ClinicalTrials.gov : NCT01750008 .


To quantify the coupled motion of the wrist during selected functional tasks and to determine the effects of constraining this coupled motion using a radial-ulnar deviation blocking splint on performance of these tasks .


Ten healthy , right-handed men performed 15 trials during selected functional tasks with and without a splint , blocking radial and ulnar deviation .


The following tasks were performed : dart throwing , hammering , basketball free-throw , overhand baseball and football throwing , clubbing , and pouring .


Kinematic coupling parameters ( coupling , kinematic path length , flexion-extension range of motion , radial-ulnar deviation range of motion , flexion-extension offset , and radial-ulnar deviation offset ) and performance were determined for each functional task .


A generalized estimation equation model was used to determine whether each kinematic coupling parameter was significantly different across tasks .


A repeated-measures generalized estimation equation model was used to test for differences in performance and kinematic coupling parameters between the free and splinted conditions .


Wrist motion exhibited linear coupling between flexion-extension and radial-ulnar deviation , demonstrated by R ( 2 ) values from 0.70 to 0.99 .


Average wrist coupling and kinematic path lengths were significantly different among tasks .


Coupling means and kinematic path lengths were different between free and splinted conditions across all tasks other than pouring .


Performance was different between wrist conditions for dart throwing , hammering , basketball shooting , and pouring .


Wrist kinematic coupling parameters are task specific in healthy individuals .


Functional performance is decreased when wrist coupling is constrained by an external splint .


Surgical procedures that restrict wrist coupling may have a detrimental effect on functional performance as defined in the study .


Patients may benefit from surgical reconstructive procedures and wrist rehabilitation protocols designed to restore kinematic coupling .


This open randomized study compares the effects of 24-week-long treatment with rosuvastatin and with atorvastatin coadministered with ezetimibe on the parameters of carbohydrate metabolism and the plasma levels of adipokynes in patients with coronary artery disease and type 2 diabetes mellitus or impaired glucose tolerance ( IGT ) .


A total of 31 patients with coronary artery disease and type 2 diabetes mellitus or IGT were recruited in the study .


Patients were randomized into two groups : group 1 included patients who received rosuvastatin therapy in an average dose of 12.5 mg/day ( n = 16 ) ; group 2 included patients who received combination treatment with atorvastatin in an average dose of 13.3 mg/day and ezetimibe ( 10 mg ) ( n = 15 ) .


Plasma levels of lipids , apoB , apoA1 , glucose , insulin , leptin , and adiponectin were evaluated ; HOMA-IR index ( an empty stomach insulin , mu/l x fasting glucose , mmol/l ) / 22.5 ) was calculated .


During the therapy , the LDL-C and apoB levels decreased by 51.7 % and 42.3 % in group 1 and by 51.8 % and 44.9 % in group 2 , respectively .


Reduction in the triglyceride levels was significantly more pronounced in group 2 than in group 1 : 43.2 % vs 17.4 % ( p < 0.02 ) , whereas we did not observed significant changes of HDL-C and apoA1 in either group .


The increases in basal glycemia , basal insulinemia , HbA1c levels ( from 6.47 % [ 6.10-7 .02 % ] to 6.98 % 16.23-8 .18 % ] ) , and HOMA-IR ( from 2.14 [ 1.68-3 .51 ] to 4.30 [ 2.31-5 .77 ] ) were found only in group 2 ( p < 0.05 for all ) .


These changes were observed in 75 % of patients of group 2 independently of the presence of diabetic state or IGT , but the changes were more pronounced in patients with disturbed carbohydrate metabolism .


Changes of leptin levels during the therapy were diverse : 73 % patients of group 1 demonstrated decrease in the leptin levels , whereas 67 % of patients in group 2 experienced 57 % - increase in the leptin concentrations .


Degree of increased basal glycemia was associated with increase in the leptin levels ( r = 0.37 , p = 0.04 ) in the entire group of patients ( n = 31 ) .


Furthermore , changes in leptin levels were negatively associated with decreased adiponectin levels ( r = -0.57 , p = 0.034 ) .


In case of equivalent degree of the decrease in LDL-C levels , 24-week combination therapy with atorvastatin and ezetimibe , unlike rosuvastatin treatment , induced increases in basal glycemia , insulinemia , HbA1c , and HOMA-IR index irrespective of the presence of carbohydrate metabolism disturbances before treatment .


Our data suggest that adiponectin and leptin are involved in the mechanisms of adverse metabolic effects of the combination of atorvastatin and ezetimibe .


Mild traumatic brain injury ( mTBI ) and postconcussion syndrome ( PCS ) are common among military combatants .


Hyperbaric oxygen ( HBO2 ) is a proposed treatment for these conditions , but it has not been rigorously studied .


The objective of this study was to determine the effects of HBO2 by 3 months post compression at 2 commonly employed dosing levels to treat PCS ; whether specific subgroups may have benefited ; and if no overall effect was found , whether benefit is masked by other conditions .


This randomized , double-blind , sham-controlled study was conducted at the Naval Air Station in Pensacola , Florida on 61 male Marines with a history of mTBI and PCS .


Intervention consisted of 40 once daily 60-minute hyperbaric chamber compressions at 2.0 atmospheres absolute ( ATA ) at 1 of 3 randomly preassigned oxygen fractions , resulting in respective blinded groups with an oxygen-breathing exposure equivalent to ( 1 ) surface air ( sham ) , ( 2 ) 100 % oxygen at 1.5 ATA , or ( 3 ) 100 % oxygen at 2.0 ATA .


The main outcome measure was the Rivermead Post-Concussion Questionnaire-16 ( RPQ-16 ) collected before compressions and at 2 later points .


The interaction of time by intervention group was not significant for improvement on the RPQ-16 .


Nor was there evidence of efficacy on the RPQ-16 for any subgroup .


No significant time by intervention interaction was found for any functional , cognitive , or psychomotor secondary outcome measure at an unadjusted 0.05 significance level .


Using a randomized control trial design and analysis including a sham , results showed no evidence of efficacy by 3 months post-compression to treat the symptomatic , cognitive , or behavioral sequelae of PCS after combat-related mTBI .


To assess and compare the safety and efficacy of allapinine and quinidine bisulphate in the treatment of patients with persistent atrial fibrillation after cardioversion .


Design -- Prospective , randomised , open study .


Patients -- 73 consecutive patients ( men only , mean age 44 11 years ) with persisnent atrial fibrillation and flutter .


Interventions -- 37 patients were randomised to allapinine ( ALP ) ( 1.5 mg/kg/d ) , 36 to quinidine bisulphate ( QUIN ) ( 15 mg/kg/d ) with subsequent successful pharmacological or electrical cardioversion .


Main outcome measures -- Recurrence of atrial fibrillation or side effects .


In the ALP group 15 of the 37 patients developed atrial fibrillation up to 12 month of follow-up , while in the QUIN group 20 patients developed atrial fibrillation and 5 experienced significant side effects .


Relative risk ( RR ) ( ALP vs QUIN ) 0.58 ( 95 % CI 0.37-0 .91 , p < 0.02 ) .


The number needed to treat ( NNT ) was ( -3.48 ) ( 14.2-1 .97 harm ) .


When 5 patients with significant side effects were excluded from the analysis RR was 0.62 ( 95 % CI 0.39-1 .0 , p = 0.052 ) and NNT -- ( -4.1 ) ( 122.7-2 .1 harm ) but power of the study was too low -- 67 % .


Allapinine is as effective as quinidine bisulphate in the long term treatment of patients with persistent atrial fibrillation after successful cardioversion but causes significantly less side effects .