Non-inferiority of ILPS versus glargine was demonstrated : least-squares mean between-treatment difference ( ILPS minus glargine ) ( 95 % CI ) was 0.22 % ( 0.06 , 0.38 ) .


Mean HbA1c reduction was less for ILPS - versus glargine-treated patients ( -1.160.84 vs. -1.400.97 % , p = 0.008 ) .


Endpoint HbA1c < 7.0 % was achieved by 53.7 % ( ILPS ) and 61.7 % ( glargine ) ( p = NS ) .


Overall hypoglycaemia rates ( p = NS ) and severe hypoglycaemia incidence ( p = NS ) were similar .


Nocturnal hypoglycaemia rate was higher in patients treated with ILPS versus glargine ( p = 0.004 ) .


Weight gain was similar between groups ( ILPS : 0.273.38 kg ; glargine : 0.663.93 kg , p = NS ) .


Endpoint total insulin doses were lower in patients treated with ILPS versus glargine ( 0.300.17 vs. 0.370.17 IU/kg/day , p < 0.001 ) .


ILPS was non-inferior to glargine for HbA1c change over 24weeks , but was associated with less HbA1c reduction and more nocturnal hypoglycaemia .


Treat-to-target basal insulin therapy improves glycaemic control and is associated with minimal weight gain when added to OAMs and exenatide BID for suboptimally controlled T2D .


Cerebral blood flow velocity ( CBFV ) measured by transcranial Doppler sonography has provided information on cerebral perfusion in patients undergoing infant heart surgery , but no studies have reported a relationship to early postoperative and long-term neurodevelopmental outcomes .


CBFV was measured in infants undergoing biventricular repair without aortic arch reconstruction as part of a trial of hemodilution during cardiopulmonary bypass ( CPB ) ; CBFV ( Vm , mean ; Vs , systolic ; Vd , end-diastolic ) in the middle cerebral artery and change in Vm ( rVm ) were measured intraoperatively and up to 18 hours post-CPB .


Neurodevelopmental outcomes , measured at 1 year of age , included the psychomotor development index ( PDI ) and mental development index ( MDI ) of the Bayley Scales of Infant Development-II .


CBFV was measured in 100 infants ; 43 with D-transposition of the great arteries , 36 with tetralogy of Fallot , and 21 with ventricular septal defects .


Lower Vm , Vs , Vd , and rVm at 18 hours post-CPB were independently related to longer intensive care unit duration of stay ( p < 0.05 ) .


In the 85 patients who returned for neurodevelopmental testing , lower Vm , Vs , Vd , and rVm at 18 hours post-CPB were independently associated with lower PDI ( p < 0.05 ) and MDI ( p < 0.05 , except Vs : p = 0.06 ) scores .


Higher Vs and rVm at 18 hours post-CPB were independently associated with increased incidence of brain injury on magnetic resonance imaging in 39 patients .


Postoperative CBFV after biventricular repair is related to early postoperative and neurodevelopmental outcomes at 1 year of age , possibly indicating that low CBFV is a marker of suboptimal postoperative hemodynamics and cerebral perfusion .


Patients with acute coronary syndromes ( ACS ) display diffuse coronary atheroma instability and heightened risk of early and late recurrent coronary events .


We compared the long-term antiatherosclerotic efficacy of high-intensity statins in patients with ACS when compared with stable disease .


Study of Coronary Atheroma by Intravascular Ultrasound : Effect of Rosuvastatin Versus Atorvastatin ( SATURN ) used serial intravascular ultrasound measures of coronary atheroma volume in patients treated with rosuvastatin 40 mg or atorvastatin 80 mg for 24 months .


The overall effect of high-intensity statins on the change in coronary percent atheroma volume and major adverse cardiovascular events ( death/nonfatal myocardial infarction/coronary revascularization ) were evaluated in this post hoc analysis .


When compared with non-ACS patients ( n = 678 ) , patients with ACS ( n = 361 ) were younger , actively smoking , and have had a previous myocardial infarction ( all P < 0.001 ) .


At baseline , patients with ACS exhibited lower high-density lipoprotein cholesterol ( 43.511 versus 45.811 mg/dL ; P = 0.002 ) , a higher apolipoprotein B : apolipoprotein A-1 ratio ( 0.900.24 versus 0.830.24 ; P < 0.001 ) and greater percent atheroma volume ( 37.38.5 % versus 35.98.1 % ; P = 0.01 ) when compared with non-ACS patients .


Despite similar achieved levels of lipid and inflammatory markers after high-intensity statin therapy , patients with ACS demonstrated greater percent atheroma volume regression than non-ACS patients ( -1.460.14 versus -0.890.13 ; P = 0.003 ) .


After propensity-weighted multivariable adjustment , baseline percent atheroma volume ( P < 0.001 ) and an ACS clinical presentation ( P = 0.02 ) independently associated with plaque regression .


The 24-month major adverse cardiovascular events-free survival was similar between patients with ACS and non-ACS ( 90.6 versus 92.9 % ; P = 0.25 ) .


Long-term high-intensity statin therapy caused greater plaque regression and comparable major adverse cardiovascular events rates in ACS when compared with non-ACS patients .


Despite a higher clinical risk profile , patients with ACS harbor a more modifiable disease substrate and seem to benefit the most from potent statin therapy .


Beside traditional dysphagia therapy , neuromuscular electrical stimulation ( NMES ) has been proposed to treat patients with dysphagia .


Considering the complexity of the nerve-muscle interaction during swallowing , the underlying physiology of NMES remains unclear .


Here , we addressed the question of whether NMES can modify upper esophageal sphincter ( UES ) dynamics .


In a prospective study , 26 healthy volunteers performed water swallows with and without NMES .


The stimulus was applied in a participant - and operator-initiated stimulation above , near , and below the motor threshold .


Swallowing parameters were measured using high-resolution manometry .


The UES relaxation time was found to be extended by 10 % , indicating a modification in UES dynamics .


The chosen NMES paradigm influenced the involuntary swallowing phase by extending relaxation time , providing more time for bolus passage into the esophagus .


Future studies will have to evaluate if this effect can be found in patients with dysphagia and whether it is beneficial for treatment .


Aim of this prospective study was to investigate the effectiveness of eutectic mixture of local anaesthetic ( EMLA ) patches on every abdominal incision for pain relief after gynaecologic laparoscopic surgery .


A total of 121 women were prospectively randomised to receive either placebo ( control group ) or EMLA ( study group ) patches on all abdominal incisions .


Postoperative pain was assessed 24 and 48 h after surgery using the short form of the McGill Pain Questionnaire ( SF-MPQ ) .


The amount of analgesic pain medication on demand was assessed in both groups .


Sixty women were allocated to the study group and 61 patients to the control group before laparoscopic surgery .


There were no statistically significant differences regarding age , body mass index ( BMI ) , duration of surgery and blood loss comparing both groups .


There were no statistically significant differences between both groups with regard to postoperative total pain scores 24 h ( McGill total score : 31.77 27.95 vs. 36.80 31.39 , p = 0.3535 ) and 48 h ( McGill total score : 19.18 20.09 vs. 26.61 27.70 , p = 0.0942 ) after surgery .


Time to mobilisation after surgery ( hours ) was significantly shorter in the study group ( 5.01 3.72 vs. 5.78 3.04 , p = 0.0423 ) .


Despite of a significant reduction of time for mobilisation transdermal anaesthetic patches after gynaecologic laparoscopic surgery did not lead to decreased postoperative pain scores .


Haiti has experienced rapid urbanization that has exacerbated poverty and undernutrition in large slum areas .


Stunting affects 1 in 5 young children .


We aimed to test the efficacy of a daily lipid-based nutrient supplement ( LNS ) for increased linear growth in young children .


Healthy , singleton infants aged 6-11 mo ( n = 589 ) were recruited from an urban slum of Cap Haitien and randomly assigned to receive : 1 ) a control ; 2 ) a 3-mo LNS ; or 3 ) a 6-mo LNS .


The LNS provided 108 kcal and other nutrients including vitamin A , vitamin B-12 , iron , and zinc at 80 % of the recommended amounts .


Infants were followed monthly on growth , morbidity , and developmental outcomes over a 6-mo intervention period and at one additional time point 6 mo postintervention to assess sustained effects .


The Bonferroni multiple comparisons test was applied , and generalized least-squares ( GLS ) regressions with mixed effects was used to examine impacts longitudinally .


Baseline characteristics did not differ by trial arm except for a higher mean age in the 6-mo LNS group .


GLS modeling showed LNS supplementation for 6 mo significantly increased the length-for-age z score ( SE ) by 0.13 0.05 and the weight-for-age z score by 0.12 0.02 compared with in the control group after adjustment for child age ( P < 0.001 ) .


The effects were sustained 6 mo postintervention .


Morbidity and developmental outcomes did not differ by trial arm .


A low-energy , fortified product improved the linear growth of young children in this urban setting .


The trial was registered at clinicaltrials.gov as NCT01552512 .


Blood pressure ( BP ) control for renal protection is essential for patients with type 2 diabetes .


Our objective in this analysis of Veterans Affairs Diabetes Trial ( VADT ) data was to learn whether on-study systolic BP ( SBP ) , diastolic BP ( DBP ) , and pulse pressure ( PP ) affected renal outcomes measured as albumin-to-creatinine ratio ( ACR ) and estimated glomerular filtration rate ( eGFR ) .


The VADT was a prospective , randomized study of 1,791 veterans with type 2 diabetes to determine whether intensive glucose control prevented major cardiovascular events .


In this post hoc study , time-varying covariate survival analyses and hazard ratios ( HR ) were used to determine worsening of renal outcomes .


Compared with SBP 105-129 mmHg , the risk of ACR worsening increased significantly for SBP 130-139 mmHg ( HR 1.88 [ 95 % CI 1.28-2 .77 ] ; P = 0.001 ) and for SBP 140 mmHg ( 2.51 [ 1.66-3 .78 ] ; P < 0.0001 ) .


Compared with a PP range of 40-49 mmHg , PP < 40 was associated with significantly lowered risk of worsening ACR ( 0.36 [ 0.15-0 .87 ] ; P = 0.022 ) and PP 60 with significantly increased risk ( 2.38 [ 1.58-3 .59 ] ; P < 0.0001 ) .


Analyses of BP ranges associated with eGFR worsening showed significantly increased risk with rising baseline SBP and an interaction effect between SBP 140 mmHg and on-study A1C .


These patients were 15 % more likely than those with SBP < 140 mmHg to experience eGFR worsening ( 1.15 [ 1.00-1 .32 ] ; P = 0.045 ) for each 1 % ( 10.9 mmol/mol ) A1C increase .


SBP 130 mmHg and PP > 60 mmHg were associated with worsening ACR .


The results suggest that treatment of SBP to < 130 mmHg may lessen ACR worsening .


The interaction between SBP 140 mmHg and A1C suggests that the effect of glycemic control on reducing progression of renal disease may be greater in hypertensive patients .


Protease inhibitor-based antiretroviral therapy ( ART ) has been associated with preterm birth in some studies .


We examined risk factors for preterm birth among women randomized to lopinavir/ritonavir ( LPV/r ) - or efavirenz ( EFV ) - based ART .


This was a planned secondary analysis of the PROMOTE-Pregnant Women and Infants Study , an open-label , randomized controlled trial comparing the risk of placental malaria among HIV-infected , ART-naive pregnant Ugandan women assigned to initiate LPV/r - or EFV-based ART at 12-28 weeks gestation .


Gestational age was determined based on last menstrual period and ultrasound biometry .


All women received bednets and trimethoprim-sulfamethoxazole .


Stillbirths , spontaneous abortions , and multiple gestations were excluded from the primary analysis .


Potential risk factors for preterm birth ( < 37 weeks gestation ) were evaluated by univariate and multivariate logistic regression .


Three hundred fifty-six women were included in this analysis .


At enrollment , median gestational age was 21 weeks and median CD4 cell count was 368 cells per cubic millimeter .


14.7 % of deliveries in the EFV arm and 16.2 % in the LPV/r arm were preterm .


Preterm birth was associated with gestational weight gain below 0.1 kg/week versus 0.1 kg/week or more [ odds ratio ( OR ) = 2.49 ; 95 % confidence interval ( CI ) : 1.38 to 4.47 ; P = 0.003 ] .


Neither ART regimen of LPV/r versus EFV ( OR = 1.12 ; 95 % CI : 0.63 to 2.00 ; P = 0.69 ) nor placental malaria ( OR = 0.74 ; 95 % CI : 0.38 to 1.44 ; P = 0.37 ) was associated with preterm birth .


LPV/r was not associated with an increased risk of preterm birth compared with EFV .


However , interventions are needed to address modifiable risk factors for preterm birth , such as nutritional status ( ClinicalTrials.gov , NCT00993031 ) .


The optimal substrate ablation approach in patients with persistent atrial fibrillation ( Per AF ) remains unclear .


This was a prospective randomized study comparing the efficacy of limited ( continuous complex fractionated atrial electrogram , CFAE : < 60 milliseconds ) versus extensive ( continuous CFAE plus variable CFAE : < 120 milliseconds ) atrial substrate modification in Per AF patients .


We enrolled 120 Per AF patients in the study , and 30 patients with AF termination after pulmonary vein isolation ( PVI ) were excluded .


In the remaining 90 patients , 45 were treated with limited approach ( Group 1 ) and 45 with an extensive approach ( Group 2 ) .


The end point of the study was the incidence of an atrial arrhythmia recurrence postblanking period .


The patients were followed up for 15 months with 3-month clinical reviews , electrograms ( ECGs ) , Holter recordings , and echocardiographic monitoring .


Procedural AF termination and the single procedural efficacy were statistically comparable between the 2 groups ( 48.9 % vs. 63.4 % in Groups 1 and 2 , respectively , P = 0.289 ) .


During the follow-up , patients who received limited ablation had a lower incidence of recurrent AFL ( P = 0.04 ) , and better reverse remodeling of the left atrium ( LA , P = 0.04 ) .


After 2 procedures , the freedom from any atrial arrhythmia was better in Group 2 ( 62.2 % vs. 87.8 % , P = 0.009 ) .


Those with longstanding AF and a larger baseline LA size responded better to the extensive ablation .


In the Per AF patients who failed to achieve AF termination after PVI alone , a specific atrial substrate modification approach targeting only continuous CFAEs could be considered as an initial ablation strategy .


Alcohol misuse among military service members from the recent conflicts in Iraq and Afghanistan is over two times higher compared to misuse in the civilian population .


Unfortunately , in addition to experiencing personal consequences from alcohol misuse , partners and family members of alcohol-misusing service members also suffer in negative ways from their loved one 's drinking .


These family members represent important catalysts for helping their loved ones identify problem drinking and overcoming the barriers to seeking care .


This paper describes the protocol to a pilot study evaluating a 4-session , web-based intervention ( WBI ) for concerned partners ( CPs ) of service members with alcohol misuse .


The WBI will be adapted from the Community Reinforcement and Family Training ( CRAFT ) intervention .


In the first phase , we will develop and beta-test the WBI with 15-20 CPs .


In the second phase , we will randomize CPs to WBI ( n = 50 ) or to delayed-WBI ( n = 50 ) and evaluate the impact of the WBI on CPs ' perceptions of service member help-seeking and drinking , as well as the CP 's well-being and relationship satisfaction 3months after the intervention .


In the third phase , we will recruit 15-20 service members whose partners have completed the study .


We will interview the service members to learn how the CP-focused WBI affected them and to assess whether they would be receptive to a follow-on WBI module to help them .


This project has the potential to benefit a large population of military service members who may be disproportionately affected by recent conflicts and whose drinking misuse would otherwise go undetected and untreated .


It also develops a new prevention model that does not rely on service members or partners attending a hospital or clinical facility to access care .


NCT02073825 .


To identify predictive factors associated with the development of pressure ulcers in patients at risk who receive standardized preventive care .


Numerous studies have examined factors that predict risk for pressure ulcer development .


Only a few studies identified risk factors associated with pressure ulcer development in hospitalized patients receiving standardized preventive care .


Secondary analyses of data collected in a multicentre randomized controlled trial .


The sample consisted of 610 consecutive patients at risk for pressure ulcer development ( Braden Score < 17 ) receiving standardized preventive care measures .


Patient demographic information , data on skin and risk assessment , medical history and diagnosis were collected during 26months ( December 2007-January 2010 ) .


Predictive factors were identified using multivariate statistics .


Pressure ulcers in category II-IV were significantly associated with non-blanchable erythema , urogenital disorders and higher body temperature .


Predictive factors significantly associated with superficial pressure ulcers were admission to an internal medicine ward , incontinence-associated dermatitis , non-blanchable erythema and a lower Braden score .


Superficial sacral pressure ulcers were significantly associated with incontinence-associated dermatitis .


Despite the standardized preventive measures they received , hospitalized patients with non-blanchable erythema , urogenital disorders and a higher body temperature were at increased risk for developing pressure ulcers .


Improved identification of at-risk patients can be achieved by taking into account specific predictive factors .


Even if preventive measures are in place , continuous assessment and tailoring of interventions is necessary in all patients at risk .


Daily skin observation can be used to continuously monitor the effectiveness of the intervention .


The use of liver as a reference tissue for semi-quantification of tumour FDG uptake may not be valid in hepatic steatosis ( HS ) .


Previous studies on the relation between liver FDG uptake and HS have been contradictory probably because they ignored blood glucose ( BG ) .


Because hepatocyte and blood FDG concentrations equalize , liver FDG uptake parallels BG , which must therefore be considered when studying hepatic FDG uptake .


We therefore re-examined the relation between HS and liver uptake taking BG into account .


This was a retrospective study of 304 patients undergoing routine PET/CT with imaging 60min post-FDG .


Average standard uptake value ( SUVave ) , maximum SUV ( SUVmax ) and CT density ( index of HS ) were measured in a liver ROI .


Blood pool SUV was based on the left ventricular cavity ( SUVLV ) .


Correlations were assessed using least squares fitting of continuous data .


Patients were also divided into BG subgroups ( < 4 , 4-5 , 5-6 , 6-8 , 8-10 and 10 + mmol/l ) .


SUVave , SUVmax and SUVLV displayed similar relations with BG .


SUVmax/SUVLV , but not SUVave/SUVLV , correlated significantly with BG .


SUVmax , but not SUVave , correlated inversely with CT density before and after adjusting for BG .


SUVmax/SUVave correlated more strongly with CT density than SUVmax .


CT density correlated inversely with SUVmax/SUVLV but positively with SUVave/SUVLV .


Hepatic SUV is more influenced by BG than by HS .


Its relation with BG renders it unsuitable as a reference tissue .


Nevertheless , hepatic fat does correlate positively with liver SUV , although this is seen only with SUVmax because SUVave is ` diluted ' by hepatic fat .


To test whether a breakfast including eggs ( EB ) containing high-quality protein decreases subsequent food intake and increases satiety-related hormones in overweight or obese adults more than a breakfast including cereal ( CB ) of lower protein quality , but matched for energy density and macronutrient composition .


Twenty healthy overweight or obese subjects were randomized to eat an EB or a CB daily under supervision for one week , followed by a crossover to the opposite breakfast week after a two-week washout period .


On days 1 and 7 of each test week , a structured lunch was provided ad libitum .


Food intake , hunger and satiety scores , and blood parameters were measured before and after breakfast .


Outcomes were analyzed using mixed effects statistical models for repeated measures analysis of variance .


Compared to the CB week , during the EB week , a ) feeling of fullness was greater ( P < 0.05 ) on day 1 but not on day 7 ; b ) energy intake was not significantly lower on either day ; c ) right before lunch , acylated ghrelin was lower and PYY3-36 was higher on day 1 ( P < 0.01 and < 0.002 , respectively ) but not on day 7 ; d ) PYY3-36 , but not ghrelin , showed greater rise between breakfast and lunch on days 1 ( P < 0.001 ) and 7 ( P < 0.01 ) .


Despite a highly similar energy density and macronutrient composition , the higher protein quality breakfast significantly influenced fullness , ghrelin and PYY3-36 .


Only the effect on PYY3-36 lasted throughout the week .


A next step would be to test if the benefits are pronounced and lasting , if protein quality of all meals is increased .


Neoadjuvant chemotherapy with trastuzumab for patients with HER2-positive breast cancer can produce a pathological complete response in the breast in 30-65 % of patients .


We investigated the effect of the timing of trastuzumab administration with anthracycline and taxane neoadjuvant chemotherapy .


This randomised trial was done at 36 centres in the USA and Puerto Rico .


Women with operable HER2-positive invasive breast cancer were randomly assigned ( 1:1 ) with a biased coin minimisation algorithm , stratified for age , tumour size , and hormone receptor status .


Neither patients nor investigators ( except for a cardiac safety review panel ) were masked to treatment assignment .


Patients randomly assigned to sequential treatment received fluorouracil 500 mg/m ( 2 ) , epirubicin 75 mg/m ( 2 ) , and cyclophosphamide 500 mg/m ( 2 ) ( FEC-75 ) on day 1 of a 21-day cycle for four cycles followed by paclitaxel 80 mg/m ( 2 ) and trastuzumab 2 mg/kg ( after a 4 mg/kg loading dose ) once per week for 12 weeks , while those randomly assigned to the concurrent treatment group received paclitaxel and trastuzumab once per week for 12 weeks followed by four cycles of FEC-75 ( on day 1 of each 21-day cycle ) and once-weekly trastuzumab , in the same doses as the sequential group .


Surgery , including evaluation of the axilla , was done within 6 weeks of completion of neoadjuvant treatment .


The primary outcome was the percentage of patients who had a pathological complete response in the intention-to-treat population .


The study is registered with ClinicalTrials.gov , number NCT00513292 .


From Sept 15 , 2007 , to Dec 15 , 2011 , 282 women were enrolled ( 140 in the sequential group , 142 in the concurrent group ) .


Two patients in the sequential group withdrew consent before starting treatment .


78 of 138 ( 565 % , 95 % CI 478-649 ) patients who received sequential treatment had a pathological complete response in the breast versus 77 of 142 ( 542 % , 95 % CI 457-626 ) who received concurrent treatment ( difference 23 % , 95 % CI -93 to 139 ) .


No treatment-related deaths occurred .


The most common severe toxic effects were neutropenia ( 35 [ 253 % ] of 138 patients in the sequential group vs 45 [ 317 % ] of 142 patients in the concurrent group ) and fatigue ( six [ 43 % ] vs 12 [ 85 % ] ) .


Left ventricular ejection fraction dropped below the institutional lower limit of normal at week 12 in one ( 08 % ) of 130 patients who received sequential treatment and four ( 29 % ) of 137 patients who received concurrent treatment ; by week 24 , it had dropped below this limit in nine ( 71 % ) of 126 patients and in six ( 46 % ) of 130 patients , respectively .


Concurrent administration of trastuzumab with anthracyclines offers no additional benefit and is not warranted .


US National Cancer Institute .


To compare the difference of the efficacy on knee osteoarthritis ( KOA ) between the combined therapy of acupuncture and moxibustion and western medication , and explore the better therapeutic method for KOA .


One hundred and sixty patients were divided into a combined therapy group and a western medication group , 80 cases in each one according to the visit sequence , with the random number table adopted .


In the combined therapy group , the main points were selected from the local painful sites , combined with the acupoints based on the syndrome differentiation and distal acupoints on the affected meridians .


The lifting , thrusting or rotating technique was used and the reinforcing or reducing manipulation was applied according to the syndrome differentiation .


`` Duanci '' or `` Shuci '' needling technique was used specially at the extra points and Ashi points .


The needling sensation relied on the patients ' tolerance .


After acupuncture , the heat-sensitive moxibustion with pure moxa stick was applied over the local painful sites around knee joint and Shenshu ( BL 23 ) to detect the heat-sensitized points .


Acupuncture and moxibustion were given once every day .


The treatment of 5 days made 1 session .


There were 2 days at the interval between two sessions .


In the western medication group , glucosamine sulfate capsules were prescribed for oral administration , 2 capsules each time , three times a day .


Additionally , the joint cavity injection was combined .


On the first day , sodium hyaluronate 25 mg and triamcinolone acetonide acetate 50 mg were injected .


Afterwards , on the 8th , 15th , 22nd and 29th days , sodium hyaluronate injection 25 mg was used only .


The treatment was for 5 weeks totally in the two groups .


The efficacy was analyzed statistically in 5 weeks .


The follow-up visit was conducted in 3 months and 6 months after 5 weeks treatment , respectively .


The Western Ontario and Mcmaster Universities Osteoarthritis Index ( WOMAC ) and visual analogue scale ( VAS ) were adopted to assess the recovery of joint function .


The efficacy in 5 weeks of treatment was different significantly between the two groups ( P < 0.05 ) .


The efficacy in the western medication group was better than that in the combined therapy group .


The difference in the safety assessment was remarkable ( P < 0.01 ) .


The result in the combined therapy group was superior remarkably to the western medication group .


In 3-month follow-up visit after treatment , the knee joint function was not different obviously between the two groups ( P > 0.05 ) .


In 6-month followup visit after treatment , the knee joint function was different obviously between the two groups ( P < 0.01 ) .


The result in the combined therapy group was better remarkably than that in the western medication group .


The combined therapy of acupuncture and moxibustion achieves the safe and effective therapeutic effect with less adverse reactions in the treatment of KOA .


The immediate effect in the combined therapy group is not so obvious as compared with the western medication , but the long-term efficacy is remarkably superior to western medication .


The prognostic value of time from symptom onset to reperfusion may be enhanced by the identification of Q waves on the presenting electrocardiogram ( ECG ) in patients with ST-segment elevation myocardial infarction ( STEMI ) .


We evaluated whether the relative prognostic utility of these 2 metrics was altered by sex .


Q waves in the distribution of the ST-segment elevation on the baseline ECG were evaluated by a blinded core laboratory in 2838 STEMI patients ( 2163 men and 675 women ) from the PLATelet inhibition and patient Outcomes ( PLATO ) trial who underwent percutaneous coronary intervention ( PCI ) within 12 hours of symptom onset .


Women were older ( median 63 vs 57 years ) , more likely to be diabetic ( 24.1 % vs 15.5 % ) , hypertensive ( 69.2 % vs 50.9 % ) , and a higher Killip class > I ( 8.6 % vs 5.9 % ) , as compared with men .


Whereas the Q waves frequency rose progressively over time to ECG in men , this relationship was attenuated in women ( P = .057 ) .


Q waves on the baseline ECG were associated with a higher excess hazard of 1-year vascular death in men ( hazard ratio [ HR ] 2.03 ; 95 % confidence interval [ CI ] , 1.13-3 .72 ) , and a similar trend existed in women ( HR 1.97 ; 95 % CI , 0.86-4 .51 ) .


Women with baseline Q waves tended to have higher risk of 1-year vascular death than men as continuous time from symptom onset to PCI increased ( P [ interaction ] = .182 ) .


These differences in the evolution of baseline Q waves and relationship between time from symptom onset and vascular death in women and men deserve recognition in future studies of STEMI .


In many countries a high proportion of births begin as induced labours .


Induction can be lengthy if cervical priming is required prior to induction .


This usually occurs as an inpatient , however , an alternative is to allow women to go home after satisfactory fetal monitoring .


The aim of this study was to assess the preferences of women for cervical priming for induction of labour in an outpatient or inpatient setting .


A discrete choice experiment ( DCE ) was conducted alongside a randomised trial of inpatient and outpatient cervical priming ( the OPRA trial ) in two maternity hospitals in South Australia .


362 participants were included , and women 's preferences for cervical priming for induction of labour were assessed .


Women were willing to accept an extra 1.4 trips to hospital ( 2.4 trips total ) and a total travel time of 73.3 minutes to be able to return to their own home while waiting for the priming to work .


For enhanced inpatient services , women were willing to accept a total travel time of 54.7 minutes to have a private room with private bathroom while waiting for the priming to work .


The overall benefit score for outpatient priming was 3.63 , 3.59 for enhanced inpatient care and 2.89 for basic inpatient care , suggesting slightly greater preferences for outpatient priming .


Preferences for outpatient priming increased when women could return to their own home ( compared to other offsite accommodation ) , and decreased with more trips to hospital and longer travel time .


Our results suggest that outpatient priming was slightly more preferred than either enhanced inpatient priming or basic care ; these results should be confirmed in different clinical settings .


There may be merit in providing women information about both options in the future , as preferences varied according to the characteristics of the services on offer and the sociodemographic background of the woman .


Tesamorelin is a synthetic analogue of growth hormone-releasing factor ( GRF ) , which increases basal and pulsatile growth hormone ( GH ) secretion and subsequently increases insulin-like growth factor ( IGF ) -1 .


Limited information is available about the pharmacokinetics of this compound .


Consequently , the aim of this study was to characterize the population pharmacokinetics of tesamorelin in HIV-infected patients and healthy subjects .


A total of 38 HIV-infected patients and healthy subjects receiving subcutaneous tesamorelin doses of 1 or 2mg administered daily during 14 consecutive days were included in the analysis .


An open one-compartment model with first - and zero-order absorption and first-order elimination was developed to best describe the data using NONMEM ( ) VII .


The effect of different covariates on tesamorelin pharmacokinetics was investigated .


Model evaluation was performed using predictive checks and non-parametric bootstrap .


Plasma clearance and its interindividual variability [ % coefficient of variation ( CV ) ] was estimated to be 1,060 L/h ( 33.6 % ) .


Volume of distribution was calculated to be 200L ( 17.7 % ) .


Age , body size measures , race and health status were not related to tesamorelin pharmacokinetic parameters within the range of covariates studied .


The fraction of tesamorelin absorbed by a first-order process is 13.1 % higher on day 14 compared with day 1 .


Predictive checks and non-parametric bootstrap demonstrated that the model is appropriate in describing the time course of tesamorelin plasma concentrations in both HIV-infected patients and healthy subjects .


An open one-compartment model with first and zero order absorption processes and linear elimination is suitable to characterize the pharmacokinetics of tesamorelin .


The fraction of tesamorelin absorbed by a first-order process evolves with time .


No clinically relevant covariates were identified as predictors of tesamorelin pharmacokinetics .


Neuron-specific enolase ( NSE ) is a widely-used biomarker for prognostication of neurological outcome after cardiac arrest , but the relevance of recommended cutoff values has been questioned due to the lack of a standardized methodology and uncertainties over the influence of temperature management .


This study investigated the role of NSE as a prognostic marker of outcome after out-of-hospital cardiac arrest ( OHCA ) in a contemporary setting .


A total of 686 patients hospitalized after OHCA were randomized to targeted temperature management at either 33C or 36C .


NSE levels were assessed in blood samples obtained 24 , 48 , and 72 h after return of spontaneous circulation .


The primary outcome was neurological outcome at 6 months using the cerebral performance category score .


NSE was a robust predictor of neurological outcome in a baseline variable-adjusted model , and target temperature did not significantly affect NSE values .


Median NSE values were 18 ng/ml versus 35 ng/ml , 15 ng/ml versus 61 ng/ml , and 12 ng/ml versus 54 ng/ml for good versus poor outcome at 24 , 48 , and 72 h , respectively ( p < 0.001 ) .


At 48 and 72 h , NSE predicted neurological outcome with areas under the receiver-operating curve of 0.85 and 0.86 , respectively .


High NSE cutoff values with false positive rates 5 % and tight 95 % confidence intervals were able to reliably predict outcome .


High , serial NSE values are strong predictors of poor outcome after OHCA .


Targeted temperature management at 33C or 36C does not significantly affect NSE levels .


( Target Temperature Management After Cardiac Arrest [ TTM ] ; NCT01020916 ) .


Physical activity ( PA ) has documented health benefits , but older Latinos are less likely to engage in leisure time PA than older non-Latino whites .


Dance holds a promise as a culturally appropriate form of PA that challenges individuals physically and cognitively .


This paper describes a randomized controlled trial that will test the efficacy of BAILAMOS , a 4-month Latin dance program followed by a 4-month maintenance program , for improving lifestyle PA and health outcomes .


Older adults ( n = 332 ) , aged 55 + , Latino/Hispanic , Spanish speaking , with low PA levels , and at risk for disability will be randomized to one of two programs , a dance program or health education control group .


BAILAMOS is a 4-month program that meets two times per week for one 1h per session .


Dance sessions focus on instruction , including four styles of dance , and couples dancing .


Bi-monthly Fiestas de Baile ( dance parties ) are also included , in which participants dance and practice what they have learned .


Monthly 1-hour discussion sessions utilize a Social Cognitive framework and focus on knowledge , social support , and self-efficacy to increase lifestyle PA. .


The health education control group will meet one time per week for two 2h per session .


Primary outcomes including PA changes and secondary outcomes including self-efficacy , physical function , cognitive function , and disability will be assessed at baseline , 4 , and 8 months .


It is hypothesized that PA , self-efficacy , physical function , cognitive function , and functional limitations and disability scores will be significantly better in the BAILAMOS group at 4 and 8 months compared to the control group .


The purpose of this study was to evaluate the influence of an early cardiac rehabilitation ( CR ) program on health-related quality of life ( HRQL ) and functional capacity in patients who recently experienced an acute myocardial infarction ( AMI ) .


This program was initiated in the inpatient setting and was followed by an unsupervised outpatient intervention .


After the same inpatient care plan , low-risk patients who experienced an AMI were randomized into 2 groups : ( 1 ) a control group ( CG ) ( n = 43 ) entailing usual care and ( 2 ) an intervention group ( IG ) ( n = 45 ) entailing outpatient ( unsupervised ) CR primarily centered on a progressive walking program .


Initially , all patients underwent a supervised exercise program with early mobilization beginning 12hours after an AMI .


On hospital discharge , all patients were classified according to cardiovascular risk .


Quality of life was evaluated by the MacNew Heart Disease HRQL questionnaire 30 days after discharge .


Functional capacity was determined by a 6-minute walk test ( 6MWT ) distance on the day of inpatient discharge as well as 30 days afterward .


The HRQL global score was higher in the IG compared with the CG 30 days after discharge ( P < 0.001 ) ; physical and emotional domain scores were both significantly higher in the IG ( P < 0.001 ) .


Furthermore , the IG showed a greater 6MWT distance compared with the CG ( P < 0.001 ) .


A CR program based on early progressive exercises , initiated by supervised inpatient training and followed by an unsupervised outpatient program , improved HRQL and functional capacity in patients at low cardiovascular risk who recently experienced an AMI .


To determine the dose-related effects of a novel probiotic combination , I. 31 , on irritable bowel syndrome ( IBS ) - related quality of life ( IBS-QoL ) .


A multicenter , randomized , double-blind , placebo-controlled intervention clinical trial with three parallel arms was designed .


A total of 84 patients ( 53 female , 31 male ; age range 20-70 years ) with IBS and diarrhea according to Rome-III criteria were randomly allocated to receive one capsule a day for 6 wk containing : ( 1 ) I. 31 high dose ( n = 28 ) ; ( 2 ) I. 31 low dose ( n = 27 ) ; and ( 3 ) placebo ( n = 29 ) .


At baseline , and 3 and 6 wk of treatment , patients filled the IBSQoL , Visceral Sensitivity Index ( VSI ) , and global symptom relief questionnaires .


During treatment , IBS-QoL increased in all groups , but this increment was significantly larger in patients treated with I. 31 than in those receiving placebo ( P = 0.008 ) .


After 6 wk of treatment , IBS-QoL increased by 18 3 and 22 4 points in the high and the low dose groups , respectively ( P = 0.041 and P = 0.023 vs placebo ) , but only 9 3 in the placebo group .


Gut-specific anxiety , as measured with VSI , also showed a significantly greater improvement after 6 wk of treatment in patients treated with probiotics ( by 10 2 and 14 2 points , high and low dose respectively , P < 0.05 for both vs 7 1 score increment in placebo ) .


Symptom relief showed no significant changes between groups .


No adverse drug reactions were reported following the consumption of probiotic or placebo capsules .


A new combination of three different probiotic bacteria was superior to placebo in improving IBS-related quality of life in patients with IBS and diarrhea .


Pantoprazole magnesium ( pantoprazole-Mg ) may display extended inhibition of the proton pump with the potential for improved clinical efficacy in gastro-oesophageal reflux disease ( GERD ) .


To compare the efficacy of pantoprazole-Mg and esomeprazole in GERD .


Gastro-oesophageal reflux disease ( Los Angeles grades A-D ) patients were randomised to 4weeks of treatment with pantoprazole-Mg ( n = 290 ) or esomeprazole ( n = 288 ) , both 40mg once daily , in this multicentre ( 14 Brazilian sites in 9 cities ) , double-blind study , with an additional 4weeks ' treatment in nonresponding patients .


Severity of oesophagitis ( at endoscopy ) and GERD-related symptoms ( ReQuest-GI ) were assessed .


The primary end point was the proportion of patients in complete remission ( ReQuest-GI score < 1.73 plus endoscopic healing ) at week 4 .


Complete remission occurred in 61 % of patients in each treatment group at 4weeks ( primary endpoint ) and in 81 % and 79 % of patients in the pantoprazole-Mg and esomeprazole groups at 8weeks , with no significant differences .


Mucosal healing rates were high and not significantly different .


At 8weeks , symptom relief with pantoprazole-Mg was significantly greater than that with esomeprazole ( 91.6 % vs. 86.0 % , P = 0.0370 ) because of continued improvement in symptoms with pantoprazole-Mg from week 4 to week 8 ( P = 0.0206 ) .


Pantoprazole-Mg 40mg was at least as effective as esomeprazole 40mg for complete remission and the mucosal healing rate was high .


Symptom relief with pantoprazole-Mg continued to improve from 4 to 8weeks and was greater than that with esomeprazole at week 8 , suggesting an extended period of treatment effect ( ClinicalTrials.gov identifier : NCT01132638 ) .


Retaining HIV patients in medical care promotes access to antiretroviral therapy , viral load suppression , and reduced HIV transmission to partners .


We estimate the programmatic costs of a US multisite randomized controlled trial of an intervention to retain HIV patients in care .


Six academically affiliated HIV clinics randomized patients to intervention ( enhanced personal contact with patients across time coupled with basic HIV education ) and control [ standard of care ( SOC ) ] arms .


Retention in care was defined as 4-month visit constancy , that is , at least 1 primary care visit in each 4-month interval over a 12-month period .


We used microcosting methods to collect unit costs and measure the quantity of resources used to implement the intervention in each clinic .


All fixed and variable labor and nonlabor costs of the intervention were included .


Visit constancy was achieved by 45.7 % ( 280/613 ) of patients in the SOC arm and by 55.8 % ( 343/615 ) of patients in the intervention arm , representing an increase of 63 patients ( relative improvement 22.1 % ; 95 % confidence interval : 9 % to 36 % ; P < 0.01 ) .


The total annual cost of the intervention at the 6 clinics was $ 241,565 , the average cost per patient was $ 393 , and the estimated cost per additional patient retained in care beyond SOC was $ 3834 .


Our analyses showed that a retention in care intervention consisting of enhanced personal contact coupled with basic HIV education may be delivered at fairly low cost .


These results provide useful information for guiding decisions about planning or scaling-up retention in care interventions for HIV-infected patients .


Although previous studies have demonstrated that a variety of local anesthetics are effective to decrease pain associated with tenaculum placement , no studies directly compare an injection with a topical anesthetic .


The objective of this study was therefore to compare mean pain scores with tenaculum placement after an intracervical lidocaine injection or topical lidocaine gel .


A randomized , single-blinded trial of women presenting for office gynecologic procedures that required a tenaculum .


Women aged 18 years or older were randomized to receive either a 1 % lidocaine intracervical injection or topical application of 2 % lidocaine gel to the cervix immediately prior to tenaculum placement .


The primary outcome was pain at the time of tenaculum placement , measured on a 100 mm Visual Analog Scale .


Secondary outcomes included pain with the intervention and satisfaction with tenaculum placement .


Seventy-four women were enrolled and randomized ; 35 subjects in each group met criteria for analysis .


The two groups had similar socio-demographic characteristics .


Women who received the injection had lower mean pain levels at tenaculum placement [ 12.3 mm ( S.D. 17.4 mm ) versus 36.6 mm ( S.D. 23.0 mm ) , p < .001 ] but higher mean pain levels with study drug application [ 20.4 mm ( S.D. 19.4 mm ) versus 5.9 mm ( S.D. 8.6 mm ) , p < .001 ] .


Satisfaction with tenaculum placement was similar for the two groups .


Mean pain with tenaculum placement is lower after receiving a lidocaine injection than after receiving a topical lidocaine gel .


Satisfaction with tenaculum placement is similar with both interventions .


Over 16000 mastectomies are performed in England and Wales annually .


Acute postoperative pain and nausea are common .


The most frequently occurring long-term complications are chronic pain ( up to 50 % ) and reduced shoulder function ( reported at 35 % ) .


Regional techniques that improve acute postoperative pain relief may reduce the incidence of these complications .


This study assesses the effectiveness of a 24-hour continuous local anaesthetic in the subpectoral plane in improving postoperative pain and quality of life in patients undergoing mastectomy .


This is a randomised , double blind , placebo-controlled , two-centre , parallel group trial in women undergoing mastectomy with or without axillary involvement .


One hundred and sixty participants will be randomised in a 1:1 ratio to receive either 0.25 % levobupivacaine or 0.9 % saline by subpectoral infusion postoperatively for 24h .


All participants will be provided with an intravenous morphine patient-controlled analgesia ( PCA ) system .


Participants will be followed-up for 24h in hospital and at approximately 14days and 6months postoperatively .


Joint primary outcome measures are total morphine consumption and total pain score ( captured via patient-recorded visual analogue scale ( VAS ) 4 hourly ) during the first 24h postoperatively .


Primary statistical analysis of total pain is based on the area under the curve of pain versus time graph .


Secondary outcomes include PCA attempts in first 24h ; VAS pain scores and shoulder function by goniometry at 24h , 14days ( approximately ) and 6months ; Verbal Rating Scale pain scores in first 24h ; Brief Pain Inventory and Oxford Shoulder Score at 6months ; duration of hospital stay ; incidence of postoperative nausea and vomiting ; cost-effectiveness .


The study is approved by the South West England Research Ethics Committee ( 12/SW/0149 ) .


will be published in a peer-reviewed journal and presented at local , national and international scientific meetings .


ISRCTN46621916 .


EudraCT 2011-005775-16 .


Case conferences for people with dementia and challenging behaviors ( e.g. , apathy ) are recommended as useful tools that enable staff in nursing homes to understand the behavior of people with this type of disease .


Understanding peoples ' behaviors is the basis for the initiation of targeted interventions to improve the quality of care for people with dementia .


Furthermore , case conferences demonstrate positive effects on burnout , dementia-specific burden , and vocational action competence of the staff .


The two likely approaches for conducting case conferences include the following : A ) using a structured assessment instrument , which guides the staff in understanding the residents ' behaviors and B ) using a narrative approach in which the staff must identify the reasons for the residents ' behaviors in an unstructured manner .


Case conferences are a complex intervention , and evaluating their multiple effects is challenging .


The aim of this study protocol was to describe a likely solution for evaluating this type of complex intervention using a special cluster randomized trial .


In this stepped-wedged cluster randomized trial , the two interventions will be sequentially implemented every three months in a group of 12 nursing homes ( clusters ) with a minimum of 360 residents over 19months ( 7months of intervention for each cluster and follow-up ) .


The primary outcome is the reduction of challenging behavior ( measured with the neuropsychiatric inventory-nursing home version [ NPI-NH ] ) .


Secondary outcomes are residents ' quality of life , prescription of psychotropic medications , staff burnout , dementia-related stress , and vocational action competence .


The effectiveness of the study will be accompanied by a process evaluation .


The primary data will be analyzed using a Bayesian mixed effect model ; the secondary data will be analyzed using descriptive statistics and mixed effects models .


The implementation and effect measurement of complex interventions such as case conferences within a cluster randomized trial are challenging ( e.g. , complex and intensive training , delayed treatment effect ) .


In this study protocol , the methodological advantages and disadvantages of using the stepped wedge design to answer the research questions are discussed .


http://www.controlled-trials.com/ISRCTN20203855; registered 10 July 2013 .


Owing to their potential to act as estrogen receptor modulators and interfere with aromatase enzyme in animal studies , phytoestrogens ( PE ) may be useful as part of ovulation induction for polycystic ovary syndrome ( PCOS ) .


Patients < 35 years , presenting with infertility and PCOS , were included and randomly allocated to either group I ( clomiphene citrate ; CC ) or group II ( CC plus Cimicifugae racemosae ; CR ) .


Primary outcome was pregnancy rate .


Secondary outcomes included ovulation , midcycle serum estradiol and luteinizing hormone ( LH ) as well as mid-luteal serum progesterone .


Analysis included 98 patients in group I versus 96 patients in group II .


Both groups were matched regarding demographics and basic data .


Significant differences were elicited when comparing days until HCG injection ( 15.0 1.7 versus 12.0 1.9 , p = 0.91 ) , endometrial thickness ( mm ) ( 8.5 1.9 versus 12.5 1.9 , p < 0.001 ) , serum levels of mid-luteal and midcycle estradiol ( p < 0.001 ; Figure 2 ) , LH ( IU/ml ) ( p < 0.001 ) as well as mid-luteal progesterone ( p < 0.001 ) .


PE plus CC group had significantly higher clinical pregnancies per cycle ( 33/192 ( 17.2 % ) versus 71/204 ( 34.8 % ) , p < 0.01 ) , compared to the CC only group .


Adding CR to clomiphene-induction cycles with timed intercourse in polycystic ovarian syndrome improves cycle outcomes and pregnancy rates .


To compare response to upper-limb treatment using robotics plus motor learning ( ML ) versus functional electrical stimulation ( FES ) plus ML versus ML alone , according to a measure of complex functional everyday tasks for chronic , severely impaired stroke survivors .


Single-blind , randomized trial .


Medical center .


Enrolled subjects ( N = 39 ) were > 1 year postsingle stroke ( attrition rate = 10 % ; 35 completed the study ) .


All groups received treatment 5d/wk for 5h/d ( 60 sessions ) , with unique treatment as follows : ML alone ( n = 11 ) ( 5h/d partial - and whole-task practice of complex functional tasks ) , robotics plus ML ( n = 12 ) ( 3.5 h/d of ML and 1.5 h/d of shoulder/elbow robotics ) , and FES plus ML ( n = 12 ) ( 3.5 h/d of ML and 1.5 h/d of FES wrist/hand coordination training ) .


Primary measure : Arm Motor Ability Test ( AMAT ) , with 13 complex functional tasks ; secondary measure : upper-limb Fugl-Meyer coordination scale ( FM ) .


There was no significant difference found in treatment response across groups ( AMAT : P. 584 ; FM coordination : P. 590 ) .


All 3 treatment groups demonstrated clinically and statistically significant improvement in response to treatment ( AMAT and FM coordination : P. 009 ) .


A group treatment paradigm of 1:3 ( therapist/patient ) ratio proved feasible for provision of the intensive treatment .


No adverse effects .


Severely impaired stroke survivors with persistent ( > 1y ) upper-extremity dysfunction can make clinically and statistically significant gains in coordination and functional task performance in response to robotics plus ML , FES plus ML , and ML alone in an intensive and long-duration intervention ; no group differences were found .


Additional studies are warranted to determine the effectiveness of these methods in the clinical setting .


The IMMEDIATE ( Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care ) Trial , a randomized controlled double-blind clinical effectiveness trial of glucose-insulin-potassium ( GIK ) administered in ambulances in the out-of-hospital setting , used the Exception from Informed Consent Requirements ( EFIC ) for Emergency Research under Title 21 of the Code of Federal Regulations .


EFIC requirements include community consultation that typically involves using a variety of communication methods and venues to inform the public of the research and to receive their feedback .


Although not the primary purpose of the community consultation process , a common concern to research sponsors , staff , and institutional review boards ( IRBs ) is whether there will be a sufficient number of participants to justify mounting a study in their community .


Information from community consultation regarding the community acceptance might inform this question .


We evaluated the utility of telephone survey data done as part of the EFIC process as a way to project the ultimate rate of trial participant enrollment .


A telephone survey community consultation process was undertaken in nine communities planning to be IMMEDIATE Trial sites using a representative sampling of the target population in the areas covered by participating emergency medical service ( EMS ) agencies .


Survey respondents were read a description of the planned study and its informed consent approach that included the option for patients to decline participation in the trial while being transported for acute care in an ambulance .


Survey respondents were then asked whether they would object to participating in the study .


At the conclusion of actual trial enrollment , the Coordinating Center compared the survey results with the actual rates of enrollment at each site .


Approximately 200 ( range = 200-271 ) respondents completed the survey in each of the study communities .


Of 2079 survey respondents , 68 % ( range = 61 % -75 % ) said that they would not object to participating in the trial if experiencing a heart attack , and 85 % ( range = 79 % -89 % ) said that they would allow the study to be done in their community .


During actual trial enrollment in the communities , 79 % ( range = 63 % -91 % ) of the 828 potential participants agreed in the ambulance to have the study drug started and provided informed consent at the hospital , an average of 13 percentage-points higher than projected by the survey ( 95 % confidence interval ( CI ) : 9 % -17 % ) , 19 % higher on a relative scale ( CI : 14 % -25 % ) .


The survey-based approach to community consultation proved to be an efficient way to obtain representative input from potential clinical trial participants .


The survey data generated a relatively good and conservative estimate of the ultimate rate of trial enrollment .


This information could be useful to investigators and IRBs in projecting enrollment for clinical trials using EFIC .


To verify the clinical efficacy of acupuncture on motor dysfunction in ischemic stroke of subacute stage .


The multi-central randomized controlled trial was adopted .


One hundred and twenty-six cases of ischemic stroke of subacute stage were randomized into an acupuncture group ( 61 cases ) and a conventional treatment group ( 65 cases ) .


The basic treatment of western internal medicine and rehabilitation training were applied to the patients of the two groups .


In the acupuncture group , acupuncture was supplemented at the body points located on the extensor of the upper limbs and the flexor of the lower limbs .


In combination , scalp acupuncture was applied to NS5 , MS6 and MS6 on the affected side .


The treatment was given 5 times a week and totally 8 weeks were required .


The follow-up observation lasted for 3 months .


The scores in Fugl-Meyer scale and NIHSS scale and Barthel index were compared between the two groups before treatment , in 4 and 8 weeks of treatment and the 3-month follow-up observation after treatment separately .


In 4 and 8 weeks of treatment and the follow-up observation , Fugl-Meyer scale score was improved obviously in the patients of the two groups ( all P < 0.01 ) .


In 8 weeks of treatment and the follow-up observation , Fugl-Meyer scale score in the acupuncture groupwas im proved much apparently as compared with that in the conventional treatment group [ 68.0 ( 43.0,86.5 ) vs 52.5 ( 30.3 , 77.0 ) , 77.0 ( 49.5 , 89.0 ) vs 63.0 ( 33.0 , 84.0 ) , both P < 0.05 ] .


Except that NIHSS scale score was not reduced apparently in 4 weeks of treatment in the conventional treatment group ( P > 0.05 ) , the results of NIHSS scale at the other time points were all decreased obviously as compared with those before treatment in the patients of the two groups ( all P < 0.01 ) .


In 8 weeks of treatment and the follow-up observation , the results in the acupuncture group were reduced much apparently as compared with those in the conventional treatment group [ 5.0 ( 3.0,8.0 ) vs 7.0 ( 3.0,13.8 ) , 4.0 ( 1.5,7.0 ) vs 6.0 ( 2.0,11.7 ) , both P < 0.05 ] .


In 8 weeks of treatment and the follow-up observation , Barthel index was improved obviously as compared with that before treatment in the patients of the two groups ( all P < 0.05 ) .


The improvement in the acupuncture group was much more significant as compared with the conventional treatment group [ 75.0 ( 60.0,87.5 ) vs 65 .


O ( 36.3 , 87.5 ) , P < 0.051 .


Based on the conventional treatment , Acupuncture achieves the satisfactory clinical efficacy on motor dysfunction in ischemic stroke of subacute stage .


Fluorouracil and irinotecan-based , and gemcitabine-based regimens , are the standard of care in the first-line treatment of patients with metastatic pancreatic cancer .


New approaches are needed to improve survival and quality of life .


Whether a sequential approach alternating irinotecan , fluorouracil and gemcitabine may be effective and tolerable in patients with metastatic pancreatic cancer is unknown .


In this randomised , multicentre , open-label , phase 2 trial , patients with metastatic pancreatic adenocarcinoma , World Health Organisation ( WHO ) performance status 0-1 , and bilirubin levels < 1.5 upper limit of normal values ( ULN ) were randomised 1:1 to receive as first-line treatment either FOLFIRI .3 ( irinotecan , leucovorin and fluorouracil ) alternating with fixed-dose rate gemcitabine as 2-month periods ( FIRGEM , arm A ) , or fixed-dose rate gemcitabine alone ( arm B ) .


Treatment was continued until disease progression or limiting toxicity .


The primary end-point was the crude progression-free survival ( PFS ) rate at 6 months .


The study is registered with EudraCT ( N 2006-005703-34 ) .


Between October 2007 and March 2011 , 98 patients were enroled .


The observed 6-month PFS rate was 43.5 % ( 95 % confidence interval ( CI ) , [ 28.6-58 .4 % ] ) in arm A reaching the Fleming decision rules criteria to reject H0 and 26.1 % ( 95 % CI [ 12.9-39 .3 % ] ) in arm B. Objective response rates were 37 % ( 23-51 % ) in arm A and 10 % ( 1-19 % ) in arm B. Median PFS ( 5.0 versus 3.4 months , hazard ratio ( HR ) = 0.59 [ 0.38-0 .90 ] ) and overall survival ( 11.0 versus 8.2 months , HR = 0.71 [ 0.46-1 .10 ] ) were higher in arm A compared to arm B.


The most frequent grade 3-4 toxicities were neutropenia ( 49 % / 24 % ; febrile neutropenia , 4 % / 0 % in arms A/B ) , diarrhoea ( arm A , 12 % and arm B , 0 % ) , and nausea/vomiting ( 8 % / 4 % ) .


No toxic deaths occurred .


The FIRGEM strategy appears to be effective and feasible in patients with metastatic pancreatic cancer .


Antidepressant prescriptions have increased exponentially , burdening health care costs .


To evaluate the costs and effects of an antidepressant cessation advice in case of inappropriate long-term use in primary care , i.e. long-term usage without a ( current ) indication .


A economic evaluation during 1-year follow-up was performed , from a societal perspective , as part of a cluster-randomised controlled clinical trial ( PANDA ) .


Costs were assessed using the Trimbos/iMTA questionnaire for costs associated with psychiatric illness .


Health-related quality of life was measured using the EuroQol 5D .


Outcome was costs per quality adjusted life year ( QALY ) .


Missing values were estimated using multiple imputation , bootstrap simulations were performed to address the uncertainty surrounding the incremental cost-effectiveness ratios ( ICERs ) .


There was no difference in average QALYs between the intervention ( 0.70 ) and control group ( 0.72 ) [ difference -0.02 ( 95 % CI -0.05 to 0.10 ) ] .


The intervention group , however , was less expensive than the control group ( total costs 3636 versus 5267 , respectively ) .


Most cost-effectiveness pairs were located in the south-west quadrant of the cost-effectiveness plane , implying the intervention was less effective but also less costly .


The ICER of the pooled data was 70,180 , meaning that for one QALY lost , 70,180 is saved .


This study shows that an antidepressant cessation advice given to patients ( and their FPs ) with inappropriate long-term antidepressant usage , albeit not effective , does seem to result in a reduction of societal costs .


This reduction in costs is mostly due to reduction of productivity losses , possibly due to patient empowerment and loss of stigma .


Evidence is weak for the ability of long-term non-invasive positive pressure ventilation ( NPPV ) to improve survival in patients with stable hypercapnic chronic obstructive pulmonary disease ( COPD ) .


Previous prospective studies did not target a reduction in hypercapnia when adjusting ventilator settings .


This study investigated the effect of long-term NPPV , targeted to markedly reduce hypercapnia , on survival in patients with advanced , stable hypercapnic COPD .


This investigator-initiated , prospective , multicentre , randomised , controlled clinical trial enrolled patients with stable GOLD stage IV COPD and a partial carbon dioxide pressure ( PaCO2 ) of 7 kPa ( 51.9 mm Hg ) or higher and pH higher than 7.35 .


NPPV was targeted to reduce baseline PaCO2 by at least 20 % or to achieve PaCO2 values lower than 6.5 kPa ( 48.1 mm Hg ) .


Patients were randomly assigned ( in a 1:1 ratio ) via a computer-generated randomisation sequence with a block size of four , to continue optimised standard treatment ( control group ) or to receive additional NPPV for at least 12 months ( intervention group ) .


The primary outcome was 1-year all-cause mortality .


Analysis was by intention to treat .


The intervention was unblinded , but outcome assessment was blinded to treatment assignment .


This study is registered with ClinicalTrials.gov , number NCT00710541 .


Patients were recruited from 36 respiratory units in Germany and Austria , starting on Oct 29 , 2004 , and terminated with a record of the vital status on July 31 , 2011.195 patients were randomly assigned to the NPPV group ( n = 102 ) or to the control group ( n = 93 ) .


All patients from the control group and the NPPV group were included in the primary analysis .


1-year mortality was 12 % ( 12 of 102 patients ) in the intervention group and 33 % ( 31 of 93 patients ) in the control group ; hazard ratio 0.24 ( 95 % CI 0.11-0 .49 ; p = 0.0004 ) .


14 ( 14 % ) patients reported facial skin rash , which could be managed by changing the type of the mask .


No other intervention-related adverse events were reported .


The addition of long-term NPPV to standard treatment improves survival of patients with hypercapnic , stable COPD when NPPV is targeted to greatly reduce hypercapnia .


German Lung Foundation ; ResMed , Germany ; Tyco Healthcare , Germany ; and Weinmann , Germany .


Previous phase III studies in patients with advanced Parkinson 's disease ( PD ) not adequately controlled on levodopa demonstrated significant reduction of ` off ' time with rotigotine transdermal system up to 16 mg/24 h. However , the minimal effective dose has not been established .


This international , randomized , double-blind , placebo-controlled study ( SP921 ; NCT00522379 ) investigated rotigotine dose response up to 8 mg/24 h.


Patients with advanced idiopathic PD ( 2.5 h of daily ` off ' time on stable doses of levodopa ) were randomized 1:1:1:1:1 to receive rotigotine 2 , 4 , 6 , or 8 mg/24 h or placebo , titrated over 4 weeks and maintained for 12 weeks .


The primary efficacy variable was change from baseline to end of maintenance in absolute time spent ` off ' .


409/514 ( 80 % ) randomized patients completed maintenance .


Mean ( SD ) baseline daily ` off ' times ( h/day ) were placebo : 6.4 ( 2.5 ) , rotigotine 2-8 mg/24 h : 6.4 ( 2.6 ) .


Rotigotine 8 mg/24 h was the minimal dose to significantly reduce ` off ' time versus placebo .


LS mean ( SE ) absolute change in daily ` off ' time ( h/day ) from baseline was -2.4 ( 0.28 ) with rotigotine 8 mg/24 h , and -1.5 ( 0.26 ) with placebo ; absolute change in ` off ' time in the 8 mg/24 h group compared with placebo was -0.85 h/day ( 95 % CI -1.59 , -0.11 ; p = 0.024 ) .


There was an apparent dose-dependent trend .


Adverse events ( AEs ) reported at a higher incidence in the rotigotine 8 mg/24 h group versus placebo included application site reactions , nausea , dry mouth , and dyskinesia ; there was no worsening of insomnia , somnolence , orthostatic hypotension , confusional state or hallucinations , even in patients 75 years of age .


The minimal statistically significant effective dose of rotigotine to reduce absolute ` off ' time was 8 mg/24 h.


The AE profile was similar to previous studies .


Metformin reduces cardiovascular risk in patients with type 2 diabetes seemingly independent of lowering blood glucose concentration .


We assessed the cardiovascular effects of metformin in individuals without type 2 diabetes .


We did a single-centre , double-blind , placebo-controlled trial at the Glasgow Clinical Research Facility ( Glasgow , UK ) .


We enrolled patients taking statins who did not have type 2 diabetes but who did have coronary heart disease and large waist circumferences .


Participants were randomly assigned ( 1:1 ) by computer to either metformin ( 850 mg twice daily ) or matching placebo in block sizes of four .


Patients , investigators , trial staff , and statisticians were masked to treatment allocation .


The primary endpoint was progression of mean distal carotid intima-media thickness ( cIMT ) over 18 months in the modified intention-to-treat population .


Secondary endpoints were changes in carotid plaque score ( in six regions ) , measures of glycaemia ( HbA1c , fasting glucose , and insulin concentrations , and Homeostasis Model Assessment of Insulin Resistance [ HOMA-IR ] ) , and concentrations of lipids , high sensitivity C-reactive protein , and tissue plasminogen activator .


The trial was registered at ClinicalTrials.gov , number NCT00723307 .


We screened 356 patients , of whom we enrolled 173 ( 86 in the metformin group , 87 in the placebo group ) .


Average age was 63 years .


At baseline , mean cIMT was 0717 mm ( SD 0129 ) and mean carotid plaque score was 243 ( SD 155 ) .


cIMT progression did not differ significantly between groups ( slope difference 0007 mm per year , 95 % CI -0006 to 0020 ; p = 029 ) .


Change of carotid plaque score did not differ significantly between groups ( 001 per year , 95 % CI -023 to 026 ; p = 092 ) .


Patients taking metformin had lower HbA1c , insulin , HOMA-IR , and tissue plasminogen activator compared with those taking placebo , but there were no significant differences for total cholesterol , HDL-cholesterol , non-HDL-cholesterol , triglycerides , high sensitivity C-reactive protein , or fasting glucose .


138 adverse events occurred in 64 patients in the metformin group versus 120 in 60 patients in the placebo group .


Diarrhoea and nausea or vomiting were more common in the metformin group than in the placebo group ( 28 vs 5 ) .


Metformin had no effect on cIMT and little or no effect on several surrogate markers of cardiovascular disease in non-diabetic patients with high cardiovascular risk , taking statins .


Further evidence is needed before metformin can be recommended for cardiovascular benefit in this population .


Chief Scientist Office ( Scotland ) .


Most patients with hip fractures are characterised by older age ( > 70 years ) , frailty , and functional deterioration , and their long-term outcomes are poor with increased costs .


We compared the effectiveness and cost-effectiveness of giving these patients comprehensive geriatric care in a dedicated geriatric ward versus the usual orthopaedic care .


We did a prospective , single-centre , randomised , parallel-group , controlled trial .


Between April 18 , 2008 , and Dec 30 , 2010 , we randomly assigned home-dwelling patients with hip-fractures aged 70 years or older who were able to walk 10 m before their fracture , to either comprehensive geriatric care or orthopaedic care in the emergency department , to achieve the required sample of 400 patients .


Randomisation was achieved via a web-based , computer-generated , block method with unknown block sizes .


The primary outcome , analysed by intention to treat , was mobility measured with the Short Physical Performance Battery ( SPPB ) 4 months after surgery for the fracture .


The type of treatment was not concealed from the patients or staff delivering the care , and assessors were only partly masked to the treatment during follow-up .


This trial is registered with ClinicalTrials.gov , number NCT00667914 .


We assessed 1077 patients for eligibility , and excluded 680 , mainly for not meeting the inclusion criteria such as living in a nursing home or being aged less than 70 years .


Of the remaining patients , we randomly assigned 198 to comprehensive geriatric care and 199 to orthopaedic care .


At 4 months , 174 patients remained in the comprehensive geriatric care group and 170 in the orthopaedic care group ; the main reason for dropout was death .


Mean SPPB scores at 4 months were 512 ( SE 020 ) for comprehensive geriatric care and 438 ( SE 020 ) for orthopaedic care ( between-group difference 074 , 95 % CI 018-130 , p = 0010 ) .


Immediate admission of patients aged 70 years or more with a hip fracture to comprehensive geriatric care in a dedicated ward improved mobility at 4 months , compared with the usual orthopaedic care .


The results suggest that the treatment of older patients with hip fractures should be organised as orthogeriatric care .


Norwegian Research Council , Central Norway Regional Health Authority , St Olav Hospital Trust and Fund for Research and Innovation , Liaison Committee between Central Norway Regional Health Authority and the Norwegian University of Science and Technology , the Department of Neuroscience at the Norwegian University of Science and Technology , Foundation for Scientific and Industrial Research at the Norwegian Institute of Technology ( SINTEF ) , and the Municipality of Trondheim .


Community level interventions to improve maternal and child health have been supported and well evaluated in resource poor settings , but less so in developed countries .


PRISM -- Program of Resources , Information and Support for Mothers -- was a primary care and community-based cluster-randomised trial in sixteen municipalities in Victoria , Australia , which aimed to reduce depression in mothers and improve their physical health .


The aim of this paper is to report the longer term outcomes of PRISM and to reflect on lessons learned from this universal community intervention to improve maternal health .


Maternal health outcome data in PRISM were collected by postal questionnaire at six months and two years .


At two years , the main outcome measures included the Edinburgh Postnatal Depression Scale ( EPDS ) and the SF-36 .


Secondary outcome measures included the Experience of Motherhood Scale ( EOM ) and the Parenting Stress Index ( PSI ) .


A primary intention to treat analysis was conducted , adjusting for the randomisation by cluster .


7,169 / 18,424 ( 39 % ) women responded to the postal questionnaire at two years -3,894 ( 40 % ) in the intervention arm and 3,275 ( 38 % ) in the comparison arm .


Respondents were mostly representative on available population data comparisons .


There were no differences in depression prevalence ( EPDS13 ) between the intervention and comparison arms ( 13.4 % vs 13.1 % ; ORadj = 1.06 , 95 % CI 0.91-1 .24 ) .


Nor did women 's mental health ( MCS : 48.6 vs 49.1 ) or physical health scores ( PCS : 49.1 vs 49.0 ) on the SF-36 differ between the trial arms .


Improvement in maternal mental and physical health outcomes at the population level in the early years after childbirth remains a largely unmet challenge .


Despite the lack of effectiveness of PRISM intervention strategies , important lessons about systems change , sustained investment and contextual understanding of the workability of intervention strategies can be drawn from the experience of PRISM .


Trial Registration .


Controlled-Trials .


com ISRCTN03464021 .


To compare the safety and efficacy of a single subconjunctival injection of methylprednisolone and a standard postoperative steroid regimen in terms of intraocular inflammation and intraocular pressure ( IOP ) after uncomplicated phacoemulsification surgery .


Two groups of 25 patients each were included in this prospective randomized controlled trial .


Patients in the injection group were given a subconjunctival injection of 20 mg methylprednisolone and the topical group received the conventional postoperative care with steroid eye drops ( dexamethasone 1 mg/ml ) .


The patients were examined 1 week and 1 month after surgery .


Slit-lamp evaluation of anterior chamber inflammation and IOP were performed .


Changes in IOP of 2.4 mmHg were considered clinically relevant .


In the injection group , mean IOP decreased from 15.4 2.2 mmHg ( baseline ) to 14.1 3.2 mmHg at 1 week ( p = 0.03 ) .


The topical group had a stable IOP at 1 week ( 16.3 2.6 mmHg ) compared to baseline ( 16.1 2.7 mmHg ; p = 0.74 ) .


At 1 month , mean IOP was 14.3 2.6 mmHg ( p = 0.03 ) in the injection group and 15.6 2.3 mmHg ( p = 0.2 ) in the topical group .


The intragroup changes were neither statistically significant nor clinically relevant at any postoperative visit .


Both groups had the highest values of intraocular inflammation at the 1-week postoperative visit , followed by a decline to barely traceable levels at 1 month .


The difference was not clinically relevant at any postoperative visit .


The subconjunctival injection of methylprednisolone appears to be as safe and effective as the conventional treatment , and it might therefore be considered for treatment of individuals with compliance issues .


To examine the feasibility , acceptability , and potential effectiveness of an online intervention targeting college smokers .


The incentives involved discounted or free goods and services from businesses proximal to each campus .


A randomized controlled trial was conducted with 122 current smokers recruited from 2 Southeastern US universities .


The intervention involved health behavior monitoring , targeted messaging , and incentives for healthy goods and services versus the American Cancer Society 's Guide to Quitting Smoking online .


The intervention achieved greater adherence and utilization ( p 's < .001 ) .


Overall , 55.6 % learned about a local business through this program .


At end-of-treatment , intervention participants less frequently attempted to quit ( p = .02 ) but smoked fewer cigarettes/day ( p = .05 ) .


Both groups demonstrated significant end-of-treatment cessation rates .


This intervention demonstrated feasibility and acceptability .


The optimal model of total dose and fraction size for patients with locally recurrent nasopharyngeal carcinoma treated with intensity-modulated radiotherapy ( IMRT ) remains unclear .


The authors designed a randomized phase 2 clinical trial to investigate the efficacy of 2 different models , with the objective of determining an optimal model .


Between January 2003 and December 2007 , a total of 117 patients with locally recurrent nonmetastatic nasopharyngeal carcinoma were randomized to 2 different models of total dose and fraction size : group A ( 59 patients ) received 60 gray in 27 fractions and group B ( 58 patients ) received 68 gray in 34 fractions .


Both groups received 5 daily fractions per week .


All patients received IMRT alone .


The median follow-up was 25.0 months .


The 5-year overall survival in group A was higher than that in group B ( 44.2 % vs 30.3 % ; P = .06 ) , and the local failure-free survival in group A was slightly lower than that in group B ( 63.7 % vs 71.0 % ; P = .41 ) .


Severe late complications were the main cause of death .


The incidences of mucosal necrosis and massive hemorrhage in patients in group B were significantly higher than those among patients in group A at 50.8 % versus 28.8 % ( P = .02 ) and 31.0 % versus 18.6 % ( P = .12 ) , respectively .


Tumor volume ( P < .01 ) and model of total dose and fraction size ( P = .03 ) were found to be significant factors for mucosal necrosis and massive hemorrhage .


Appropriately decreasing the total dose and increasing the fraction size can achieve local control similar to that achieved with a higher dose after IMRT ; furthermore , it can improve overall survival by significantly reducing the incidence of severe late complications including mucosal necrosis and massive hemorrhage .


To examine the effect of chocobar ice cream containing bifidobacteria on salivary mutans streptococci and lactobacilli .


A double-blind , randomised controlled trial was conducted with 30 subjects ( 18 to 22 years of age ) divided into 2 groups , test ( chocobar ice cream with probiotics ) and control ( chocobar ice cream without probiotics ) .


The subjects were instructed to eat the allotted chocobar ice cream once daily for 18 days .


Saliva samples collected at intervals were cultured on Mitis Salivarius agar and Rogosa agar and examined for salivary mutans streptococci and lactobacilli , respectively .


The Mann-Whitney U-test , Friedman and Wilcoxon signed-rank tests were used for statistical analysis .


Postingestion in the test group , a statistically significant reduction ( p < 0.05 ) of salivary mutans streptococci was recorded , but a non-significant trend was seen for lactobacilli .


Significant differences were was also observed between follow-ups .


Short-term daily ingestion of ice cream containing probiotic bifidobacteria may reduce salivary levels of mutans streptococci in young adults .


The standard therapy for women with unexplained infertility is gonadotropin or clomiphene citrate .


Ovarian stimulation with letrozole has been proposed to reduce multiple gestations while maintaining live birth rates .


We enrolled couples with unexplained infertility in a multicenter , randomized trial .


Ovulatory women 18 to 40 years of age with at least one patent fallopian tube were randomly assigned to ovarian stimulation ( up to four cycles ) with gonadotropin ( 301 women ) , clomiphene ( 300 ) , or letrozole ( 299 ) .


The primary outcome was the rate of multiple gestations among women with clinical pregnancies .


After treatment with gonadotropin , clomiphene , or letrozole , clinical pregnancies occurred in 35.5 % , 28.3 % , and 22.4 % of cycles , and live birth in 32.2 % , 23.3 % , and 18.7 % , respectively ; pregnancy rates with letrozole were significantly lower than the rates with standard therapy ( gonadotropin or clomiphene ) ( P = 0.003 ) or gonadotropin alone ( P < 0.001 ) but not with clomiphene alone ( P = 0.10 ) .


Among ongoing pregnancies with fetal heart activity , the multiple gestation rate with letrozole ( 9 of 67 pregnancies , 13 % ) did not differ significantly from the rate with gonadotropin or clomiphene ( 42 of 192 , 22 % ; P = 0.15 ) or clomiphene alone ( 8 of 85 , 9 % ; P = 0.44 ) but was lower than the rate with gonadotropin alone ( 34 of 107 , 32 % ; P = 0.006 ) .


All multiple gestations in the clomiphene and letrozole groups were twins , whereas gonadotropin treatment resulted in 24 twin and 10 triplet gestations .


There were no significant differences among groups in the frequencies of congenital anomalies or major fetal and neonatal complications .


In women with unexplained infertility , ovarian stimulation with letrozole resulted in a significantly lower frequency of multiple gestation but also a lower frequency of live birth , as compared with gonadotropin but not as compared with clomiphene .


( Funded by the National Institutes of Health and others ; ClinicalTrials.gov number , NCT01044862 . )


To assess the optimal pancreatic phase delay in terms of parenchymal enhancement and tumor-to-pancreas contrast with a bolus-tracking method .


Patients referred for suspicion of pancreatic tumor and undergoing 64-detector computed tomography scanner were randomized to an individualized scan delay of 10 , 20 , or 30seconds of nonionic contrast material ( 370mg I/mL ) after aortic enhancement above 150 Hounsfield units .


The volume of contrast was adjusted to patient weight .


Pancreatic and tumor enhancements were measured .


Statistical analysis included analysis of variance and post hoc Tukey tests .


One hundred and fifty patients were randomized to individualized scan delays of 10 , 20 , or 30seconds .


Pancreatic parenchymal enhancement in all patients ( n = 150 ) was significantly higher with a delay of 20 or 30 seconds than that with 10 seconds ( P < .001 for both ) .


Tumor-to-pancreas contrast for solid tumors ( n = 59 ) was significantly higher with a delay of 30seconds than that with 10seconds ( P = .015 ) .


Adenocarcinoma-to-pancreas contrast during pancreatic phase was significantly higher for a 20 - or 30-second delay than for a 10-second delay ( P = .027 and .011 , respectively ) for one reader .


With a flow rate of 4mL/s and weight-adjusted contrast volume , an individualized scan delay of 30seconds after aortic transit time revealed higher pancreatic enhancement and tumor-to-pancreas contrast than that with a delay of 10seconds .


Epidemiologic and preclinical data , and a small randomized trial in Boston , suggest that vitamin D supplementation may improve winter-related atopic dermatitis ( AD ) .


To determine the effect of vitamin D supplementation on winter-related AD .


We performed a randomized , double-blind , placebo-controlled trial of Mongolian children with winter-related AD ( clinicaltrials.gov identifier : NCT00879424 ) .


Baseline eligibility included age 2 to 17 years , AD score 10 to 72 using the Eczema Area and Severity Index ( EASI ) , and winter-related AD ( eg , history of AD worsening during the fall-to-winter transition ) .


Subjects were enrolled in Ulaanbaatar during winter and randomly assigned to oral cholecalciferol ( 1000 IU/day ) versus placebo for 1 month .


All children and parents received emollient and patient education about AD and basic skin care .


The main outcomes were changes in EASI score and in Investigator 's Global Assessment .


The 107 enrolled children had a mean age of 9 years ( SD 5 ) , and 59 % were male .


Their median age of AD onset was 3 months ( interquartile range 2 months to 1 year ) and mean EASI score at baseline 21 ( SD 9 ) .


One-month follow-up data were available for 104 ( 97 % ) children .


Compared with placebo , vitamin D supplementation for 1 month produced a clinically and statistically significant improvement in EASI score ( adjusted mean change : -6.5 vs -3.3 , respectively ; P = .04 ) .


Moreover , change in Investigator 's Global Assessment favored vitamin D over placebo ( P = .03 ) .


There were no adverse effects in either group .


Vitamin D supplementation improved winter-related AD among Mongolian children , a population likely to have vitamin D deficiency in winter .


Since bolus administration of capsaicin has been shown to reduce appetite and ad libitum energy intake , this study elucidated the satiating effect of the less pungent capsaicin analog , nonivamide , on subjective feelings of hunger , ad libitum food intake , and satiating hormones in moderately overweight male subjects .


Following a randomized , crossover design , 24 male subjects ( BMI 27.5 1.53 kg/m ( 2 ) ) received either 75 g glucose in 300 mL water ( control treatment , CT ) or the same glucose solution supplemented with 0.15 mg nonivamide ( nonivamide treatment , NT ) .


Ratings of hunger were assessed before and 2 h after each intervention by means of visual analog scales .


Ad libitum energy and macronutrient intakes from a standardized breakfast 2 h postintervention were calculated .


Plasma glucose , insulin , peptide YY ( 3-36 ) , glucagon-like peptide 1 , and serotonin were quantified in blood samples drawn before and 15 , 30 , 60 , 90 , and 120 min after each intervention .


NT reduced subjective feelings of hunger and ad libitum energy and carbohydrate intakes from a standardized breakfast compared to CT. .


Plasma analysis revealed higher mean plasma glucagon-like peptide 1 and serotonin concentrations after NT versus CT. .


Addition of 0.15 mg nonivamide to a glucose solution reduced ad libitum energy intake from a standardized breakfast in moderately overweight men .


Selective decontamination of the digestive tract ( SDD ) and selective oropharyngeal decontamination ( SOD ) are prophylactic antibiotic regimens used in intensive care units ( ICUs ) and associated with improved patient outcome .


Controversy exists regarding the relative effects of both measures on patient outcome and antibiotic resistance .


To compare the effects of SDD and SOD , applied as unit-wide interventions , on antibiotic resistance and patient outcome .


Pragmatic , cluster randomized crossover trial comparing 12 months of SOD with 12 months of SDD in 16 Dutch ICUs between August 1 , 2009 , and February 1 , 2013 .


Patients with an expected length of ICU stay longer than 48 hours were eligible to receive the regimens , and 5881 and 6116 patients were included in the clinical outcome analysis for SOD and SDD , respectively .


Intensive care units were randomized to administer either SDD or SOD .


Unit-wide prevalence of antibiotic-resistant gram-negative bacteria .


Secondary outcomes were day-28 mortality , ICU-acquired bacteremia , and length of ICU stay .


In point-prevalence surveys , prevalences of antibiotic-resistant gram-negative bacteria in perianal swabs were significantly lower during SDD compared with SOD ; for aminoglycoside resistance , average prevalence was 5.6 % ( 95 % CI , 4.6 % -6.7 % ) during SDD and 11.8 % ( 95 % CI , 10.3 % -13.2 % ) during SOD ( P < .001 ) .


During both interventions the prevalence of rectal carriage of aminoglycoside-resistant gram-negative bacteria increased 7 % per month ( 95 % CI , 1 % -13 % ) during SDD ( P = .02 ) and 4 % per month ( 95 % CI , 0 % -8 % ) during SOD ( P = .046 ; P = .40 for difference ) .


Day 28-mortality was 25.4 % and 24.1 % during SOD and SDD , respectively ( adjusted odds ratio , 0.96 [ 95 % CI , 0.88-1 .06 ] ; P = .42 ) , and there were no statistically significant differences in other outcome parameters or between surgical and nonsurgical patients .


Intensive care unit-acquired bacteremia occurred in 5.9 % and 4.6 % of the patients during SOD and SDD , respectively ( odds ratio , 0.77 [ 95 % CI , 0.65-0 .91 ] ; P = .002 ; number needed to treat , 77 ) .


Unit-wide application of SDD and SOD was associated with low levels of antibiotic resistance and no differences in day-28 mortality .


Compared with SOD , SDD was associated with lower rectal carriage of antibiotic-resistant gram-negative bacteria and ICU-acquired bacteremia but a more pronounced gradual increase in aminoglycoside-resistant gram-negative bacteria .


trialregister.nlIdentifier : NTR1780 .


This study explored possible mechanisms through which symptoms of posttraumatic stress disorder ( PTSD ) were reduced in a randomized controlled trial comparing the effect of a yoga intervention with an assessment control .


We examined whether changes in psychological flexibility , mindfulness , and emotion regulation strategies ( expressive suppression and reappraisal ) were associated with posttreatment PTSD symptoms for 38 women with Diagnostic and Statistical Manual of Mental Disorders Fourth Edition full or subthreshold PTSD .


Hierarchical linear regression models revealed that expressive suppression significantly decreased for the yoga group relative to the assessment control .


Psychological flexibility increased significantly for the control but not yoga group .


However , increases in psychological flexibility were associated with decreases in PTSD symptoms for the yoga but not control group .


Preliminary findings suggest that yoga may reduce expressive suppression and may improve PTSD symptoms by increasing psychological flexibility .


More research is needed to replicate and extend these findings .


Assess golimumab 's long-term efficacy/safety in psoriatic arthritis ( PsA ) .


Adults with active PsA ( 3 swollen and tender joints , active psoriasis ) were randomly assigned to subcutaneous placebo , golimumab 50mg , or golimumab 100mg every 4weeks ( q4wks ) through wk20 .


All patients received golimumab 50mg or 100mg q4wks from wk24 forward .


Methotrexate was allowed and taken by approximately half the patients .


Findings through 5years are reported herein .


Efficacy assessments included 20 % improvement in American College of Rheumatology ( ACR20 ) response , C-reactive-protein-based , 28-joint-count Disease Activity Score ( DAS28-CRP ) response , 75 % improvement in Psoriasis Area and Severity Index ( PASI75 ) scores , and PsA-modified Sharp/van der Heijde scores ( SHSs ) .


126/405 ( 31 % ) randomised patients discontinued treatment through wk252 .


Golimumab was effective in maintaining clinical improvement through year-5 ( ACR20 : 62.8-69 .9 % , DAS28-CRP : 75.2-84 .9 % for randomised patients ; PASI75 : 60.8-72 .2 % among randomised patients with 3 % body surface area involvement ) and inhibiting radiographic progression ( mean changes in PsA-modified SHS : 0.1-0 .3 ) among patients with radiographic data .


While concomitant methotrexate did not affect ACR20/PASI75 , it appeared to reduce radiographic progression .


No new safety signals were identified .


Antibodies-to-golimumab occurred in 1.8 % / 10.0 % of patients with/without methotrexate ) .


Long-term golimumab safety/efficacy in PsA was demonstrated through 5years .


NCT00265096 .


Onapristone is an antiprogestin with activity in breast cancer and is under investigation for use in endometrial , ovarian and prostate cancers .


Megestrol acetate and abiraterone generally show variability in absorption and , depending on the formulation , food effect .


This study was conducted to determine the effect of food on 10mg oral immediate-release ( IR ) onapristone and to help identify a formulation to minimize variability .


This is an open-label , randomized , crossover study to determine the pharmacokinetic profile of onapristone and its main metabolite , N-mono-desmethyl onapristone .


Twelve healthy female subjects received 10mg of oral IR onapristone after an overnight fast , or within 30min of a high-fat , high-calorie meal with a 2-week washout between dosing periods .


Onapristone plasma t1/2 ( meanSD ) was 4.360.81 h for the fasted state and 3.760.36 h for the fed state .


Following food , onapristone tmax was delayed from 1 to 4h .


Food intake was also associated with a small increase in AUC0 - of approximately 13 % and a statistically significant decrease in Cmax of approximately 18 % .


One subject experienced a 23-day delay in menses after one 10mg onapristone dose , while another subject experienced transient grade 2 NCI-CTCAE liver enzyme elevation 3weeks post dose .


The results are consistent with previous observations , indicating that there is a small increase in onapristone exposure and a significant decrease in Cmax when taken with food .


These changes are within acceptable limits set out by the FDA .


Thus , our findings indicate that onapristone could be administered without regard to food .


To review factors influencing placebo response and clinical trial outcome in depression , and suggest ways to optimize trial success in mood disorders .


PubMed searches were conducted by cross-referencing the terms depression , depressive with placebo , clinical trial , and clinical trials for studies published in English between 1970 and September 2013 .


Relevant abstracts were identified in PubMed , including clinical trials , quantitative studies , and qualitative research .


We obtained and reviewed relevant articles and utilized their information to synthesize the present review .


Included articles were grouped in the following areas of relevance : ( 1 ) biological validity of illness , ( 2 ) baseline severity of illness , ( 3 ) chronicity of the index episode of depression , ( 4 ) age of participants , ( 5 ) medical and psychiatric comorbidity , ( 6 ) probability of receiving placebo , ( 7 ) use of prospective treatment phases ( lead-in ) ( 8 ) dosing schedule , ( 9 ) trial duration , ( 10 ) frequency of follow-up assessments , and ( 11 ) study outcome measure .


Several key elements emerge as critical to the ultimate success of a clinical trial , including the probability of receiving placebo , study duration , dosing schedule , visit frequency , the use of blinded lead-in phases , the use of centralized raters , illness severity and duration , and comorbid anxiety .


Our increasing understanding of the placebo response in clinical trials of major depressive disorder lends to a , gradually , more predictable phenomenon and , hopefully , to one that becomes lesser in magnitude and variability .


Several elements have emerged that seem to play a critical role in trial success , gradually reshaping the design of clinical , translational , as well as mechanistic studies in depression .


Repetitive transcranial magnetic stimulation ( rTMS ) is a noninvasive tool for modulating cortical activity .


In this pilot study , we evaluated the effects of high frequency rTMS applied over the right inferior frontal gyrus ( IFG ) on cognitive functions in patients with amnestic mild cognitive impairment ( MCI ) or incipient dementia due to Alzheimer 's disease ( AD ) .


Ten patients ( 6 men ; 4 women , mean age of 72 8 years ; MMSE 23 3.56 ) were enrolled in a randomized , placebo-controlled study with a crossover design .


All participants received 2 sessions of 10 Hz rTMS over the non-dominant right hemisphere in random order : IFG ( active stimulation site ) and vertex ( control stimulation site ) .


Intensities were adjusted to 90 % of resting motor threshold .


A total of 2250 pulses were applied in a session .


The Trail Making Test ( TMT ) , the Stroop test , and the complex visual scene encoding task ( CVSET ) were administered before and immediately after each session .


The Wilcoxon paired test was used for data analysis .


Stimulation applied over the IFG induced improvement in the TMT parts A ( p = 0.037 ) and B ( p = 0.049 ) .


No significant changes were found in the Stroop test or the CVSET after the IFG stimulation .


We observed no significant cognitive aftereffects of rTMS applied over the vertex .


High frequency rTMS of the right IFG induced significant improvement of attention and psychomotor speed in patients with MCI/mild dementia due to AD .


This pilot study is part of a more complex protocol and ongoing research .


To estimate the efficacy of a probiotic yogurt compared to a pasteurised yogurt for the prevention of antibiotic-associated diarrhoea in children .


This was a multisite , randomised , double-blind , placebo-controlled clinical trial conducted between September 2009 and 2012 .


The study was conducted through general practices and pharmacies in Launceston , Tasmania , Australia .


Children ( aged 1-12years ) prescribed antibiotics , were randomised to receive 200g/day of either yogurt ( probiotic ) containing Lactobacillus rhamnosus GG ( LGG ) , Bifidobacterium lactis ( Bb-12 ) and Lactobacillus acidophilus ( La-5 ) or a pasteurised yogurt ( placebo ) for the same duration as their antibiotic treatment .


Stool frequency and consistency were recorded for the duration of treatment plus 1week .


Primary outcome was stool frequency and consistency , classified at different levels of diarrhoea severity .


Due to the small number of cases of diarrhoea , comparisons between groups were made using Fisher 's exact analysis .


72 children commenced and 70 children ( 36 placebo and 34 probiotic ) completed the trial .


There were no incidents of severe diarrhoea ( stool consistency 6 , 3 stools/day for 2 consecutive days ) in the probiotic group and six in the placebo group ( Fisher 's exact p = 0.025 ) .


There was also only one episode of minor diarrhoea ( stool consistency 5 , 2 stools/day for 2days in the probiotic group compared to 21 in the placebo group ( Fisher 's exact p < 0.001 ) .


The probiotic group reported fewer adverse events ( 1 had abdominal pain , 1 vomited and 1 had headache ) than the placebo group ( 6 had abdominal pain , 4 had loss of appetite and 1 had nausea ) .


A yogurt combination of LGG , La-5 and Bb-12 is an effective method for reducing the incidence of antibiotic-associated diarrhoea in children .


Australian New Zealand Clinical Trials Registry ACTRN12609000281291 .


The clinical benefits and risks of dose escalation ( DE ) for stage III non-small-cell lung cancer ( NSCLC ) remain uncertain despite the results from Radiation Therapy Oncology Group ( RTOG ) protocol 0617 .


There is significant heterogeneity of practice , with many clinicians prescribing intermediate dose levels between the 0617 study arms of 60 and 74 Gy .


This study investigated whether this strategy is associated with any survival benefits/risks by analyzing a large multi-institutional database .