Our data suggest that the body adiposity index is a useful tool for the risk assessment of type 2 diabetes mellitus in admixture populations .


This study tried to determine the efficacy and safety of low-dose intracoronary unfractionated heparin ( UFH ) in elective percutaneous coronary intervention ( PCI ) .


Two-hundred patients who underwent elective PCI of an uncomplicated lesion were included into the study .


The patients were assigned to either a control group ( 70-100 IU/kg intravenous UFH ) or a low-dose intracoronary UFH ( 1,000 IU intracoronary UFH ) group .


At 30 days , the primary end point ( composite of death , myocardial infarction , or urgent target vessel revascularization ) was similar in both groups [ intracoronary UFH group , 1.0 % ; control group , 2.0 % ; odds ratio ; 0.49 ( 95 % CI : 0.04 - 5.54 ) , P = 0.56 ] .


Post-procedural myocardial injury ( according to CK-MB , P = 0.91 ; according to Tn I , P = 0.81 ) and bleeding events ( based on TIMI criteria , P = 0.33 ; based on STEEPLE criteria , P = 0.20 ) were similar in the control and intracoronary groups .


The primary end point at 6 months was also similar between the two groups ( P = 0.33 ) .


Moreover , the health care cost at 30 days of follow-up was lower in the intracoronary group than in the control group ( 1,016 54 $ / patient vs 1,110 102 $ / patient , P < 0.001 ) .


This pilot study suggests that elective PCI could be safely performed with low-dose intracoronary UFH in the treatment of uncomplicated lesions and at a lower cost as compared to standard systemic anticoagulation.These results should be confirmed by further studies .


Varus deformity increases the risk of progression of medial compartment knee osteoarthritis .


The aim of this study was to investigate the clinical and radiographic mid-term results of closing-wedge and opening-wedge high tibial osteotomy when used to treat this condition .


From January 2001 to April 2004 , ninety-two patients were randomized to receive either a closing-wedge or an opening-wedge high tibial osteotomy .


The clinical outcome and radiographic results were examined preoperatively ; at one year ; and , for the present study , at six years postoperatively .


The outcomes that we reviewed included maintenance of the achieved correction , progression of osteoarthritis ( based on the Kellgren and Lawrence classification ) , severity of pain ( as assessed on a visual analog scale [ VAS ] ) , knee function ( as measured with the Hospital for Special Surgery [ HSS ] score and Knee injury and Osteoarthritis Outcome Score [ KOOS ] ) , walking distance , complications , and survival with conversion to a total knee arthroplasty as the end point .


The results were analyzed on the basis of the intention-to-treat principle .


Six years postoperatively , the mean hip-knee-ankle ( HKA ) angle ( and standard deviation ) was 3.2 4.1 of valgus after a closing-wedge high tibial osteotomy and 1.3 5.0 of valgus after an opening-wedge high tibial osteotomy ( p = 0.343 ) .


In both groups , the six-year postoperative HKA angles did not differ from the respective one-year postoperative angles .


No difference in the severity of pain or in knee function was found between the two groups .


Four complications ( 9 % ) occurred in the closing-wedge group and seventeen ( 38 % ) , in the opening-wedge group .


Ten ( 22 % ) of the patients in the closing-wedge group and three ( 8 % ) in the opening-wedge group needed conversion to a total knee arthroplasty within the six-year period ( p = 0.05 ) .


The difference in the percentage of cases with conversion to total knee arthroplasty was 14 % ( 95 % confidence interval [ CI ] = 21.7 to 0.2 ) .


In the group of patients without conversion to a total knee arthroplasty , there was no difference between the high tibial closing-wedge and opening-wedge osteotomies in terms of clinical outcomes or radiographic alignment at six years postoperatively .


Opening-wedge osteotomy was associated with more complications , but closing-wedge osteotomy was associated with more early conversions to total knee arthroplasty .


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


Concussion is a common injury in sport .


Most individuals recover in 7-10days but some have persistent symptoms .


The objective of this study was to determine if a combination of vestibular rehabilitation and cervical spine physiotherapy decreased the time until medical clearance in individuals with prolonged postconcussion symptoms .


This study was a randomised controlled trial .


Consecutive patients with persistent symptoms of dizziness , neck pain and/or headaches following a sport-related concussion ( 12-30years , 18 male and 13 female ) were randomised to the control or intervention group .


Both groups received weekly sessions with a physiotherapist for 8weeks or until the time of medical clearance .


Both groups received postural education , range of motion exercises and cognitive and physical rest until asymptomatic followed by a protocol of graded exertion .


The intervention group also received cervical spine and vestibular rehabilitation .


The primary outcome of interest was medical clearance to return to sport , which was evaluated by a study sport medicine physician who was blinded to the treatment group .


In the treatment group , 73 % ( 11/15 ) of the participants were medically cleared within 8weeks of initiation of treatment , compared with 7 % ( 1/14 ) in the control group .


Using an intention to treat analysis , individuals in the treatment group were 3.91 ( 95 % CI 1.34 to 11.34 ) times more likely to be medically cleared by 8weeks .


A combination of cervical and vestibular physiotherapy decreased time to medical clearance to return to sport in youth and young adults with persistent symptoms of dizziness , neck pain and/or headaches following a sport-related concussion .


NCT01860755 .


Mini percutaneous nephrolithotomy ( mini-PCNL ) and retrograde intrarenal surgery ( RIRS ) are well-established techniques with little morbidity .


The combined use of standard PCNL and the mini-PCNL or the RIRS technique was evaluated and compared to investigate their own role in the management of staghorn calculi in solitary kidney .


23 patients received combined standard PCNL and mini-PCNL ( group 1 ) , and 22 patients received combined standard PCNL and RIRS ( group 2 ) .


The treatment results and complications were evaluated and compared .


The mean operation time was 128.8 9.1 min in group 1 and 109.8 10.7 min in group 2 ( p < 0.001 ) .


The decrease in hemoglobin level in group 1 was significantly higher than that in group 2 ( 3.5 0.6 vs. 2.1 0.5 g/dl , p < 0.001 ) .


The final stone-free rate was significantly higher ( p = 0.038 ) in group 2 ( 90.9 % ) than in group 1 ( 65.2 % ) .


Combined standard PCNL and RIRS technique can extract the majority of staghorn calculi quickly by PCNL with EMS Lithoclast , and RIRS used simultaneously can reduce the need for multiple tracts and therefore reduce blood loss and potential morbidity related to multiple tracts , shorten the operation time and achieve a high stone-free rate .


Hyperhidrosis is a chronic disease characterized by increased sweat production .


Local injections of botulinum toxin A ( BTX-A ) have been extensively used for treatment of primary hyperhidrosis ( idiopathic ) .


The current treatment for this condition involves several intradermal injections , resulting in poor patient compliance due to injection-related pain .


Therefore , new protocols , including an improved anesthetic regimen , are required .


We designed the present study to determine whether JetPeel-3 , a medical device used for transdermal delivery of drugs by jet nebulization , could be used to deliver lidocaine prior to the standard multiple BTX-A injections or deliver lidocaine together with BTX-A in order to determine the protocol giving better results in terms of procedure-related pain , sweating , and patient satisfaction in subjects affected by primary axillary , palmar or plantar hyperhidrosis .


Twenty patients with a visual analog scale ( VAS ) sweating score 8 cm were randomized to receive lidocaine 2 % ( 5 mL ) delivered by JetPeel-3 followed by multiple injections of BTX-A ( 100 units ) or lidocaine 2 % ( 5 mL ) and BTX-A ( 50 units ) delivered together by JetPeel-3 .


Effect of treatment on sweating was measured by VAS ( 0 = minimum sweating ; 10 = maximum sweating ) at 3-month follow-up .


Pain induced by the procedure was assessed by VAS ( 0 = minimum pain ; 10 = maximum pain ) immediately after the procedure .


Patient satisfaction was assessed at 3-month follow-up using a 5-point scale ( 1 = not at all satisfied ; 2 = not satisfied ; 3 = partially satisfied ; 4 = satisfied ; 5 = highly satisfied ) .


Both treatment modalities reduced sweating at 3-month follow-up , if compared with baseline ( all P < 0.001 ) .


Delivery of lidocaine and BTX-A by JetPeel-3 resulted in lower procedure-related pain and reduced sweating , if compared with lidocaine delivered by JetPeel-3 followed by multiple BTX-A injections ( all P < 0.001 ) .


Patient satisfaction with the procedure was higher in the group receiving lidocaine and BTX-A treatment by JetPeel-3 , if compared with lidocaine delivered by JetPeel-3 followed by multiple BTX-A injections ( P < 0.001 ) .


No side effects were observed in both groups .


Lidocaine and BTX-A can be safely delivered together by JetPeel-3 to treat primary palmar , plantar and axillary hyperhidrosis , resulting in lower procedure-related pain , improved sweating and higher patient satisfaction , if compared with lidocaine delivered by JetPeel-3 followed by standard BTX-A injection therapy .


Our protocol delivering lidocaine and BTX-A together by JetPeel-3 requires a reduced quantity of BTX-A , further supporting the use of the transdermal drug delivery by jet nebulization over standard injection therapy for treatment of primary hyperhidrosis .


There is increasing emphasis on the importance of intraocular pressure peaks and fluctuations as risk factors for glaucoma progression .


It is well recognized that the water drinking test raises intraocular pressure and there is reasonable evidence that caffeine can also raise intraocular pressure .


The aim of this study is to directly compare the effect of a caffeine test to that of the water drinking test on intraocular pressure , in patients with glaucoma .


Prospective , observer-masked , cross-over study .


Fourteen eyes of 14 patients with primary open-angle glaucoma .


Patients were initially randomized to either caffeine test or water drinking test .


Intraocular pressure was measured in both eyes with a Goldmann applanation tonometer at baseline and every 15min for 1h , by a masked examiner .


This was repeated the following week at the same time of day for the other test ( the cross-over ) .


Peak intraocular pressure and maximum fluctuation from baseline were compared between groups using paired t-tests .


Peak and fluctuation of intraocular pressure , time of maximum frequency of peak intraocular pressure .


The maximum intraocular pressure from the water drinking test ( 19.74.1 ) was greater than the caffeine test ( 16.74.1 ) and showed greater fluctuation in intraocular pressure ( 4.32.7 mmHg [ 27.7 % ] ; P < 0.0001 ) compared with the caffeine test ( 1.81.9 mmHg [ 11.7 % ] ) ; P = 0.004 ) .


The rise in intraocular pressure was greater with water drinking test than the caffeine test .


Caffeine does not appear to provide an alternative for patients unable to tolerate the water drinking test .


Patients with knee and/or hip osteoarthritis ( OA ) are less physically active than the general population , while the benefits of physical activity ( PA ) have been well documented .


Based on the behavioral graded activity treatment , we developed a Web-based intervention to improve PA levels in patients with knee and/or hip OA , entitled `` Join2move '' .


The Join2move intervention is a self-paced 9-week PA program in which the patient 's favorite recreational activity is gradually increased in a time-contingent way .


The aim of the study was to investigate whether a fully automated Web-based PA intervention in patients with knee and/or hip OA would result in improved levels of PA , physical function , and self-perceived effect compared with a waiting list control group .


The study design was a two-armed randomized controlled trial which was not blinded .


Volunteers were recruited via articles in newspapers and health-related websites .


Eligibility criteria for participants were : ( 1 ) aged 50-75 years , ( 2 ) self-reported knee and/or hip OA , ( 3 ) self-reported inactivity ( 30 minutes of moderate PA , 5 times or less per week ) , ( 4 ) no face-to-face consultation with a health care provider other than general practitioners , for OA in the last 6 months , ( 5 ) ability to access the Internet weekly , and ( 6 ) no contra-indications to exercise without supervision .


Baseline , 3-month , and 12-month follow-up data were collected through online questionnaires .


Primary outcomes were PA , physical function , and self-perceived effect .


In a subgroup of participants , PA was measured objectively using accelerometers .


Secondary outcomes were pain , fatigue , anxiety , depression , symptoms , quality of life , self-efficacy , pain coping , and locus of control .


Of the 581 interested respondents , 199 eligible participants were randomly assigned to the intervention ( n = 100 ) or waiting list control group ( n = 99 ) .


Response rates of questionnaires were 84.4 % ( 168/199 ) after 3 months and 75.4 % ( 150/199 ) after 12 months .


In this study , 94.0 % ( 94/100 ) of participants actually started the program , and 46.0 % ( 46/100 ) reached the adherence threshold of 6 out of 9 modules completed .


At 3 months , participants in the intervention group reported a significantly improved physical function status ( difference = 6.5 points , 95 % CI 1.8-11 .2 ) and a positive self-perceived effect ( OR 10.7 , 95 % CI 4.3-26 .4 ) compared with the control group .


No effect was found for self-reported PA. .


After 12 months , the intervention group showed higher levels of subjective ( difference = 21.2 points , 95 % CI 3.6-38 .9 ) and objective PA ( difference = 24 minutes , 95 % CI 0.5-46 .8 ) compared with the control group .


After 12 months , no effect was found for physical function ( difference = 5 points , 95 % CI -1.0 to 11.0 ) and self-perceived effect ( OR 1.2 , 95 % CI 0.6-2 .4 ) .


For several secondary endpoints , the intervention group demonstrated improvements in favor of the intervention group .


Join2move resulted in changes in the desired direction for several primary and secondary outcomes .


Given the benefits and its self-help format , Join2move could be a component in the effort to enhance PA in sedentary patients with knee and/or hip OA .


The pathophysiological role of iron in Parkinson 's disease ( PD ) was assessed by a chelation strategy aimed at reducing oxidative damage associated with regional iron deposition without affecting circulating metals .


Translational cell and animal models provided concept proofs and a delayed-start ( DS ) treatment paradigm , the basis for preliminary clinical assessments .


For translational studies , we assessed the effect of oxidative insults in mice systemically prechelated with deferiprone ( DFP ) by following motor functions , striatal dopamine ( HPLC and MRI-PET ) , and brain iron deposition ( relaxation-R2 * - MRI ) aided by spectroscopic measurements of neuronal labile iron ( with fluorescence-sensitive iron sensors ) and oxidative damage by markers of protein , lipid , and DNA modification .


DFP significantly reduced labile iron and biological damage in oxidation-stressed cells and animals , improving motor functions while raising striatal dopamine .


For a pilot , double-blind , placebo-controlled randomized clinical trial , early-stage Parkinson 's patients on stabilized dopamine regimens enrolled in a 12-month single-center study with DFP ( 30 mg/kg/day ) .


Based on a 6-month DS paradigm , early-start patients ( n = 19 ) compared to DS patients ( n = 18 ) ( 37/40 completed ) responded significantly earlier and sustainably to treatment in both substantia nigra iron deposits ( R2 * MRI ) and Unified Parkinson 's Disease Rating Scale motor indicators of disease progression ( p < 0.03 and p < 0.04 , respectively ) .


Apart from three rapidly resolved neutropenia cases , safety was maintained throughout the trial .


A moderate iron chelation regimen that avoids changes in systemic iron levels may constitute a novel therapeutic modality for PD .


The therapeutic features of a chelation modality established in translational models and in pilot clinical trials warrant comprehensive evaluation of symptomatic and/or disease-modifying potential of chelation in PD .


To compare the efficacy and toxicity of the chemotherapeutic regimen containing pirarubicin and mitoxantrone on the treatment of relapsed or refractory acute myeloid leukemia ( AML ) in adults .


In this open prospective multicentre study , we randomly assigned patients with relapsed or refractory AML to receive TAE regimen ( pirarubicin + cytarabine + etoposide ) versus MAE regimen ( mitoxantrone + cytarabine + etoposide ) .


The efficacy and toxicity were compared between the two groups .


56 patients entered this clinical trial .


The complete remission ( CR ) rate on TAE arm was 79.0 % versus 55.6 % on MAE arm with the overall response ( OR ) rates of 86.8 % versus 88.9 % , respectively .


The CR was higher on TAE arm ( P = 0.035 ) but with no significant difference between the two groups regarding the overall response ( OR ) rate .


The regimens were well tolerated in both groups .


Hematologic and non-hematologic toxicity were similar except relatively lower the mean dosage of G-CSF , red blood cells and platelets transfusion on TAE arm .


No significant differences were seen between the two groups regarding the overall survival and relapse free survival rates .


TAE regimen might be an effective salvage therapy in patients with relapsed or refractory AML .


Tuberculous pericarditis is associated with high morbidity and mortality even if antituberculosis therapy is administered .


We evaluated the effects of adjunctive glucocorticoid therapy and Mycobacterium indicus pranii immunotherapy in patients with tuberculous pericarditis .


Using a 2-by-2 factorial design , we randomly assigned 1400 adults with definite or probable tuberculous pericarditis to either prednisolone or placebo for 6 weeks and to either M. indicus pranii or placebo , administered in five injections over the course of 3 months .


Two thirds of the participants had concomitant human immunodeficiency virus ( HIV ) infection .


The primary efficacy outcome was a composite of death , cardiac tamponade requiring pericardiocentesis , or constrictive pericarditis .


There was no significant difference in the primary outcome between patients who received prednisolone and those who received placebo ( 23.8 % and 24.5 % , respectively ; hazard ratio , 0.95 ; 95 % confidence interval [ CI ] , 0.77 to 1.18 ; P = 0.66 ) or between those who received M. indicus pranii immunotherapy and those who received placebo ( 25.0 % and 24.3 % , respectively ; hazard ratio , 1.03 ; 95 % CI , 0.82 to 1.29 ; P = 0.81 ) .


Prednisolone therapy , as compared with placebo , was associated with significant reductions in the incidence of constrictive pericarditis ( 4.4 % vs. 7.8 % ; hazard ratio , 0.56 ; 95 % CI , 0.36 to 0.87 ; P = 0.009 ) and hospitalization ( 20.7 % vs. 25.2 % ; hazard ratio , 0.79 ; 95 % CI , 0.63 to 0.99 ; P = 0.04 ) .


Both prednisolone and M. indicus pranii , each as compared with placebo , were associated with a significant increase in the incidence of cancer ( 1.8 % vs. 0.6 % ; hazard ratio , 3.27 ; 95 % CI , 1.07 to 10.03 ; P = 0.03 , and 1.8 % vs. 0.5 % ; hazard ratio , 3.69 ; 95 % CI , 1.03 to 13.24 ; P = 0.03 , respectively ) , owing mainly to an increase in HIV-associated cancer .


In patients with tuberculous pericarditis , neither prednisolone nor M. indicus pranii had a significant effect on the composite of death , cardiac tamponade requiring pericardiocentesis , or constrictive pericarditis .


( Funded by the Canadian Institutes of Health Research and others ; IMPI ClinicalTrials.gov number , NCT00810849 . )


Osteoporosis and cardiovascular disease may share common biological pathways , with inflammation playing a role in the development of both .


Although observational studies have suggested that statin use is associated with a lower risk of fractures , randomized trial data addressing this issue are scant .


To determine whether statin therapy reduces the risk of fracture and , in a secondary analysis , whether baseline levels of the inflammatory biomarker high-sensitivity C-reactive protein ( hs-CRP ) are associated with the risk of fracture .


The JUPITER ( Justification for the Use of Statins in Prevention : an Intervention Trial Evaluating Rosuvastatin ) trial was an international , randomized , double-blind , placebo-controlled study enrolling 17,802 men older than 50 years and women older than 60 years with hs-CRP level of at least 2 mg/L .


Participants were screened from 2003 to 2006 and observed prospectively for up to 5 years ( median follow-up , 1.9 years ) .


Rosuvastatin calcium , 20 mg daily , or placebo .


Incident fracture was a prespecified secondary end point of JUPITER .


Fractures were confirmed by radiographs , computed tomography , bone scan , or other methods .


Cox proportional hazards models were used to calculate hazard ratios ( HRs ) and associated 95 % confidence intervals for the risk of fracture according to randomized treatment assignment , as well as increasing tertiles of hs-CRP , controlling for potential confounders .


During the study , 431 incident fractures were reported and confirmed .


Among participants allocated to rosuvastatin , 221 fractures were confirmed , compared with 210 among those allocated to placebo , such that the incidence of fracture in the rosuvastatin and placebo groups was 1.20 and 1.14 per 100 person-years , respectively ( adjusted HR , 1.06 [ 95 % CI , 0.88-1 .28 ] ; P = .53 ) .


Overall , increasing baseline hs-CRP level was not associated with an increased risk of fractures ( adjusted HR for each unit increase in hs-CRP tertile , 1.06 [ 95 % CI , 0.94-1 .20 ] ; P for trend , .34 ) .


Among men and women with elevated hs-CRP level enrolled in a large trial of rosuvastatin therapy for cardiovascular disease , statin therapy did not reduce the risk of fracture .


Higher baseline hs-CRP level was not associated with an increased risk of incident fracture .


clinicaltrials.gov Identifier : NCT00239681 .


Primary data about rates of formal diagnosis of dementia in the German primary care sector are widely lacking .


Main objectives are to analyze the rate of syndrome diagnosis in primary care patients who screened positive for dementia , the distribution of differential diagnoses , and factors associated with undiagnosed dementia .


DelpHi-MV ( Dementia : life - and person-centered help in Mecklenburg-Western Pomerania ) is an ongoing general practitioner ( GP ) - based , randomized , controlled intervention trial .


A total of 4,064 patients ( 70 years , living at home ) recruited from 108 participating GP practices were screened for dementia ( DemTect < 9 ) .


Of 692 eligible patients ( 17 % ) , a total of 406 subjects ( 59 % ) provided informed consent .


Present analyses are based on the data of 243 patients with complete baseline assessment on January 1 , 2014 ( preliminary data ) .


Formal diagnoses were retrieved from the medical records of the treating GPs .


A conditional fixed effect regression analysis was performed to analyze factors associated with undiagnosed dementia .


A total of 40 % of patients who screened positive for dementia had been formally diagnosed with dementia .


Unspecified dementia was diagnosed in 53 % , vascular dementia in 24 % , and Alzheimer 's disease in 19 % of these patients .


Undiagnosed dementia was significantly associated with a higher mean score in the Mini-Mental State Examination ( odds ratio , 1.11 ; p < 0.01 , 95 % confidence interval 1.04-1 .18 ) .


The diagnosis rate of dementia in German primary care ( 40 % ) is well within the range of the international data ( 20-50 % ) .


The results emphasize the need for action to enhance recognition and differential diagnosis of dementia .


The aim was to test a new protocol of luteal phase administration of clomiphene citrate ( CC ) for ovulation induction in women with polycystic ovary syndrome ( PCOS ) .


This was a prospective , randomized , controlled trial .


Two hundred and fifty-two women ( cycles ) with PCOS were utilized to create two groups .


Patients in Group 1 ( 126 patients ) received 100mg of CC daily for 5days starting on day 5 of menses , and patients in Group 2 ( 126 patients ) received 100mg of CC daily for 5days starting the next day after finishing medroxyprogesterone acetate ( MPA ) ( before withdrawal bleeding ) .


The main outcome measures were the number of growing and mature follicles , serum E2 ( in pg/mL ) , serum progesterone ( in ng/mL ) levels , endometrial thickness ( in mm ) , pregnancy , and miscarriage rates .


The total number of follicles and the number of follicles 14mm during stimulation were significantly greater in Group 2 .


The endometrial thickness at the time of human chorionic gonadotrophin ( hCG ) administration was significantly greater in Group 2 as compared to Group 1 ( 7.841.22 and 8.810.9 , respectively ) .


Serum E2 levels were also significantly higher ( p < 0.05 ) in Group 2 as compared to Group 1 ( 449.61243.45 vs. 666.09153.41 pg/mL ) .


Pregnancy occurred in 13 patients ( 10.3 % ) in Group 2 and in 11 patients ( 8.7 % ) in Group 1 .


The difference was not statistically significant .


Luteal phase administration of CC in patients with PCOS leads to increased follicular growth and endometrial thickness , which might result in a higher pregnancy rate .


The risks associated with gestational diabetes mellitus ( GDM ) are well recognized , and there is increasing evidence to support treatment of the condition .


However , clear guidance on the ideal approach to screening for GDM is lacking .


Professional groups continue to debate whether selective screening ( based on risk factors ) or universal screening is the most appropriate approach .


Additionally , there is ongoing debate about what levels of glucose abnormalities during pregnancy respond best to treatment and which maternal and neonatal outcomes benefit most from treatment .


Furthermore , the implications of possible screening options on health care costs are not well established .


In response to this uncertainty there have been repeated calls for well-designed , randomised trials to determine the efficacy of screening , diagnosis , and management plans for GDM .


We describe a randomised controlled trial to investigate screening uptake rates and the clinical and cost effectiveness of screening in primary versus secondary care settings .


This will be an unblinded , two-group , parallel randomised controlled trial ( RCT ) .


The target population includes 784 women presenting for their first antenatal visit at 12 to 18 weeks gestation at two hospitals in the west of Ireland : Galway University Hospital and Mayo General Hospital .


Participants will be offered universal screening for GDM at 24 to 28 weeks gestation in either primary care ( n = 392 ) or secondary care ( n = 392 ) locations .


The primary outcome variable is the uptake rate of screening .


Secondary outcomes include indicators of clinical effectiveness of screening at each screening site ( primary and secondary ) including gestational week at time of screening , time to access antenatal diabetes services for women diagnosed with GDM , and pregnancy and neonatal outcomes for women with GDM .


In addition , parallel economic and qualitative evaluations will be conducted .


The trial will cover the period from the woman 's first hospital antenatal visit at 12 to 18 weeks gestation , until the completion of the pregnancy .


Current Controlled Trials : ISRCTN02232125 .


We report the role of relative lymphocyte count ( RLC ) as a potential biomarker with prognostic impact for catumaxomab efficacy and overall survival ( OS ) based on a post hoc analysis of the pivotal phase II/III study of intraperitoneal catumaxomab treatment of malignant ascites .


The impact of treatment and RLC on OS was evaluated using multivariate Cox models .


Kaplan-Meier and log-rank tests were used for group comparisons .


Survival analyses were performed on the safety population [ patients with paracentesis plus 1 dose of catumaxomab ( n = 157 ) and paracentesis alone ( n = 88 ) ] .


Determination of the optimal cutoff value for RLC was based on five optimality criteria .


OS was significantly longer with catumaxomab versus paracentesis alone ( P = 0.0219 ) .


The 6-month OS rate with catumaxomab was 28.9 % versus 6.7 % with paracentesis alone .


RLC had a positive impact on OS and was an independent prognostic factor ( P < 0.0001 ) .


In patients with RLC > 13 % ( n = 159 : catumaxomab , 100 and control , 59 ) , catumaxomab was associated with a favorable effect on OS versus paracentesis alone ( P = 0.0072 ) , with a median/mean OS benefit of 41/131 days and an increased 6-month survival rate of 37.0 % versus 5.2 % , respectively .


In patients with RLC 13 % at screening ( n = 74 : catumaxomab , 50 and control , 24 ) , the median ( mean ) OS difference between the catumaxomab and the control group was 3 ( 16 ) days , respectively ( P = 0.2561 ) .


OS was significantly improved after catumaxomab treatment in patients with malignant ascites .


An RLC > 13 % at baseline was a significant prognostic biomarker .


Primary percutaneous coronary intervention ( PCI ) has considerably improved clinical outcomes in patients with ST-segment elevation myocardial infarction ( STEMI ) when compared with thrombolytic therapy .


Prognosis after primary PCI might be further improved by decreasing stent-related complications such as stent thrombosis .


The STENTYS self-apposing stent has been shown to be superior compared with balloon-expandable stents with regard to stent apposition .


The current prospective randomized trial was designed to evaluate whether the superior stent apposition of the STENTYS stent results in clinical outcomes that are at least noninferior to a conventional balloon-expandable stent .


The APPOSITION V is a prospective , multicenter , international , single-blinded , randomized controlled trial in STEMI patients .


Randomization will be performed in a 2:1 ratio between the self-apposing nitinol bare-metal STENTYS stent and the balloon-expandable bare-metal MULTI-LINK .


The primary end point is defined as target vessel failure , which is a composite of cardiac death , target vessel-related recurrent myocardial infarction , or clinically driven target vessel revascularization , at 1-year follow-up .


Baseline intravascular ultrasound and optical coherence tomography ( OCT ) substudies will be performed in 212 and 60 subjects , respectively , and a repeat angiography at 12 to 13 months will be performed in 105 subjects , including intravascular ultrasound and OCT ( in the 60 OCT patients ) .


This study is registered on ClinicalTrials.gov with number NCT01732341 .


APPOSITION V will be the first randomized trial powered on clinical end points that directly compares the STENTYS self-apposing stent with a conventional balloon-expandable stent in patients presenting with STEMI undergoing primary PCI .


Reliability of coronary angiography by multidetector row CT ( MDCT-CA ) for stent evaluation is still a matter for debate , and it is unknown whether contrast medium characteristics may affect diagnostic performance of MDCT-CA .


We compared iomeprol-400 with iodixanol-320 to evaluate coronary stents with MDCT-CA .


We randomly assigned 254 patients undergoing coronary stent follow-up with the use of MDCT-CA to iomeprol-400 at 5.0 mL/sec flow rate ( group 1 ; n = 83 ) , iodixanol-320 at 6.2 mL/sec flow rate ( group 2 ; n = 87 ) , and iodixanol-320 at 5.0 mL/sec flow rate ( group 3 ; n = 84 ) .


Heart rate ( HR ) immediately before and at the end of scanning , HR variation , premature heart beats , and heat sensation by visual analog scale during scanning were recorded .


Mean attenuation was measured in the aortic root and coronary arteries .


Image quality score and type of artifacts were assessed .


Mean attenuation was significantly lower in group 3 than in the other groups .


In group 3 , stent evaluability was significantly higher and artifact rate was significantly lower than in group 2 ( 99 % vs. 91 % and 4 % vs. 15 % ) and group 1 ( 99 % vs. 92 % and 4 % vs. 17 % ) , respectively , mainly because of a significant lower rate of beam-hardening artifacts ( 3 cases in group 3 vs. 22 and 27 in groups 2 and 3 , respectively ) .


In group 3 , visual analog scale , HR at the end of imaging , and number of patients with premature heart beats during the scan were significantly lower than in the other groups .


Iodixanol-320 provides better image quality of coronary stents , allowing higher MDCT-CA evaluability , than iomeprol-400 .


The efficacy of pre-exposure prophylaxis ( PrEP ) in HIV will diminish with poor adherence ; pharmacologic measures of drug exposure have proven critical to PrEP trial interpretation .


We assessed drug exposure in hair against other pharmacologic and more routinely used measures to assess pill-taking .


Participants were randomized to placebo , daily PrEP , or intermittent PrEP to evaluate safety and tolerability of daily versus intermittent tenofovir/emtricitabine ( TFV/FTC ) in 2 phase II PrEP clinical trials conducted in Africa .


Different measures of drug exposure , including self-report , medication event monitoring system ( MEMS ) - caps openings , and TFV/FTC levels in hair and other biomatrices were compared .


At weeks 8 and 16 , self-reported pill-taking , MEMS-caps openings , and TFV/FTC levels in hair , plasma , and peripheral blood mononuclear cells ( PBMCs ) were measured .


Regression models evaluated predictors of TFV/FTC concentrations in the 3 biomatrices ; correlation coefficients between pharmacologic and nonpharmacologic measures were calculated .


Both trials were registered on ClinicalTrials.gov ( NCT00931346/NCT00971230 ) .


Hair collection was highly feasible and acceptable ( 100 % in week 8 ; 96 % in week 16 ) .


In multivariate analysis , strong associations were seen between pharmacologic measures and MEMS-caps openings ( all P < 0.001 ) ; self-report was only weakly associated with pharmacologic measures .


TFV/FTC hair concentrations were significantly correlated with levels in plasma and PBMCs ( correlation coefficients , 0.41-0 .86 , all P < 0.001 ) .


Measuring TFV/FTC exposure in small hair samples in African PrEP trials was feasible and acceptable .


Hair levels correlated strongly with PBMC , plasma concentrations , and MEMS-caps openings .


As in other PrEP trials , self-report was the weakest measure of exposure .


Further study of hair TFV/FTC levels in PrEP trials and demonstration projects to assess adherence/exposure is warranted .


Sleep apnea ( SA ) is associated with cardiovascular diseases and is highly prevalent in patients with pacemakers ( PMs ) .


To validate a transthoracic impedance sensor with an advanced algorithm ( sleep apnea monitoring ) for identifying severe SA .


Patients with indications for PM ( VVI/DDD ) were enrolled regardless of symptoms suggesting SA .


Severe SA diagnosis was acknowledged when the full polysomnography gave an apnea-hypopnea index ( PSG-AHI ) of 30 events/h .


The PSG-AHI was compared with the respiratory disturbance index evaluated by the SAM algorithm ( SAM-RDI ) compiled from the device during the same diagnosis night , and the performance of the device and the SAM algorithm was calculated to identify patients with severe SA .


The agreement between methods was assessed by using Bland and Altman statistics .


Forty patients ( mean age 73.8 19.1 years ; 67.5 % men ; body mass index 27.7 4.4 kg/m ( 2 ) ) were included .


Severe SA was diagnosed by PSG in 56 % of the patients .


We did not retrieve SAM-RDI data in 14 % of the patients .


An optimal cutoff value for the SAM-RDI at 20 events/h was obtained by a receiver operator characteristic curve analysis , which yielded a sensitivity of 88.9 % ( 95 % confidence interval [ CI ] 65.3 % -98.6 % ) , a positive predictive value of 88.9 % ( 95 % CI 65.3 % -98.6 % ) , and a specificity of 84.6 % ( 95 % CI 54.6 % -98.1 % ) ( n = 31 ) .


The Bland-Altman limits of agreement for PSG-AHI ( in events per hour ) were [ -14.1 to 32.4 ] .


The results suggest that an advanced algorithm using PM transthoracic impedance could be used to identify SA in patients with PMs outside the clinic or at home .


Although maintenance bacillus Calmette-Gurin ( BCG ) is the recommended treatment in high-risk non-muscle-invasive bladder cancer ( NMIBC ) , its efficacy in older patients is controversial .


To determine the effect of age on prognosis and treatment outcome in patients with stage Ta T1 NMIBC treated with maintenance BCG .


A total of 957 patients with intermediate - or high-risk Ta T1 ( without carcinoma in situ ) NMIBC were randomized in European Organization for Research and Treatment of Cancer ( EORTC ) trial 30911 comparing six weekly instillations of epirubicin , BCG , and BCG plus isoniazid followed by three weekly maintenance instillations over 3 yr .


Cox multivariate proportional hazards regression models were used to assess the relative importance of age for recurrence , progression , overall survival , and NMIBC-specific survival with adjustment for EORTC risk scores .


Overall , 822 eligible patients were included : 546 patients in the BCG with or without INH arms and 276 in the epirubicin arm .


In patients treated with BCG with or without INH , 34.1 % were > 70 yr of age and 3.7 % were > 80 yr .


With a median follow-up of 9.2 yr , patients > 70 yr had a shorter time to progression ( p = 0.028 ) , overall survival ( p < 0.001 ) , and NMIBC-specific survival ( p = 0.049 ) after adjustment for EORTC risk scores in the multivariate analysis .


The time to recurrence was similar compared with the younger patients .


BCG was more effective than epirubicin for all four end points considered , and there was no evidence that BCG was any less effective compared with epirubicin in patients > 70 yr .


In intermediate - and high-risk Ta T1 urothelial bladder cancer patients treated with BCG , patients > 70 yr of age have a worse long-term prognosis ; however , BCG is more effective than epirubicin independent of patient age .


Intravesical bacillus Calmette-Gurin for non-muscle-invasive bladder cancer is less effective in patients > 70 yr of age , but it is still more effective than epirubicin .


This study was registered with the US National Cancer Institute clinical trials database ( protocol ID : EORTC 30911 ; http://www.cancer.gov/clinicaltrials/search/view?cdrid=77075&version=HealthProfessional&protocolsearchid=12442243#StudyIdInfo_CDR0000077075 ) .


Patients with end stage renal disease on hemodialysis are affected by physiological and psychological stressors , which contribute to poor quality of life and negative clinical outcomes .


Depression , anxiety , and stress are highly prevalent in this population .


Effective interventional strategies are required to manage these psychological symptoms .


Acupressure has been believed to be one of the complementary therapies that could promote psychological wellbeing .


The aim of this study was to evaluate the effects of acupressure on depression , anxiety , stress , and general psychological distress in patients with hemodialysis .


Open-label randomized controlled trial .


Three hemodialysis centers .


A total of 108 patients with hemodialysis were randomly recruited into the acupressure group ( n = 54 ) and the control group ( n = 54 ) .


The intervention was carried out from January to March 2014 .


The acupressure group received routine hemodialysis treatment plus 15 min acupressure applied three times a week for four weeks .


The control group received only usual care with routine hemodialysis treatment .


The outcome measurements were the Depression , Anxiety Stress Scales ( DASS-21 ) , and general psychological distress using the General Health Questionnaire ( GHQ-28 ) .


Statistical analysis was performed using Wilcoxon signed-rank test to compare DASS scales and GHQ-28 scores before and after acupressure intervention .


The acupressure group had significantly lower DASS scores and GHQ scores compared to the control group , signifying improvements in depression , anxiety , stress and general psychological distress .


The sub-score of the GHQ-28 for social dysfunction , however , were similar in both groups .


Findings from this study indicates that acupressure therapy delivered three times a week for four weeks was able to significantly reduce depression , anxiety , stress , and general psychological distress in patients with hemodialysis .


This positive finding suggests that acupressure may have a role in promoting psychological wellbeing of patients .


Promoting psychological wellness will improve patients ' quality of life , and reduce negative outcomes associated with psychological illnesses and distress experienced by patients with hemodialysis .


Botulinum toxins have been widely used in cosmetic dermatology .


Neurotoxin from the CBFC26 strain ( NTC ) is a recently developed botulinum toxin type A product manufactured through refined procedures .


A double-blinded , randomized , multicentre-designed , phase III trial to investigate the non-inferiority of NTC to existing botulinum toxin A , onabotulinumtoxin A in the treatment of moderate to severe glabellar lines .


A total of 272 subjects were randomized in a 1 : 1 ratio to receive 20 U of NTC or onabotulinumtoxin A.


The primary endpoint was the response rate of physicians ' assessment ( PA ) using the Facial Wrinkle Scale at week 4 .


The secondary endpoints included the response rate of PA at weeks 8 , 12 and 16 , and photographic assessment at weeks 4 , 8 , 12 and 16 .


Subjects ' improvement assessment and subjective self-satisfaction levels were also investigated .


Response rates for maximum frown were 89.3 % in the NTC group and 81.9 % in the onabotulinumtoxin A group at week 4 .


NTC also resulted in comparable results for both the response rates of the other evaluation points and incidence of adverse events compared to those of onabotulinumtoxin A.


In subjects ' improvement assessment and photographic evaluations , NTC even demonstrated better results compared with onabotulinumtoxin A in the early phase after treatment .


Analysis of these results strongly supports the non-inferiority of NTC to onabotulinumtoxin A in the efficacy and safety .


NTC is as effective as onabotulinumtoxin A in the treatment of glabellar lines , and both products were well tolerated .


To determine whether endometrial hCG infusion at the time of human blastocyst transfer impacts implantation rates .


Randomized double-blinded placebo-controlled trial .


Academic .


Infertile couples with the female partner less than 43 years old ( n = 300 ) undergoing fresh or frozen ET of one or two blastocysts .


Patients undergoing ET were randomized into either a treatment or a control group .


The treatment group received an infusion of 500 IU of hCG diluted in ET media .


The control group received a sham infusion of ET media .


Infusions were done using a separate catheter less than 3 minutes before actual ET .


Sustained implantation rate : ongoing viable gestation ( primary outcome ) and ongoing pregnancy rate ( secondary outcome ) .


A total of 473 blastocysts were transferred into 300 patients .


There were no differences between the two groups in sustained implantation rate ( 48.1 % in the hCG group , 44.2 % in the control group ) or ongoing pregnancy rate ( 58.8 % in the hCG group , 52.0 % in the control group ) .


Endometrial infusion of hCG at the time of blastocyst ET does not improve sustained implantation rates .


NCT01643993 .


Daily oral antiretroviral preexposure prophylaxis ( PrEP ) is a promising strategy for prevention of HIV-1 acquisition .


Three clinical trials demonstrated PrEP efficacy ; however , two PrEP trials among women did not find protection against HIV-1 .


One hypothesis proposed for these divergent results is that PrEP efficacy may be reduced in populations with higher HIV-1 incidence .


Using data from the Partners PrEP Study , a randomized , placebo-controlled trial of daily oral tenofovir ( TDF ) and emtricitabine/tenofovir ( FTC/TDF ) PrEP among heterosexual HIV-1 serodiscordant couples from Kenya and Uganda , we assessed PrEP efficacy among subgroups at higher risk for HIV-1 acquisition , including subgroups of women with high HIV-1 incidence .


The overall placebo arm HIV-1 incidence was 2.0 per 100 person-years .


Among higher risk subgroups , placebo arm HIV-1 incidence ranged from 3.9 to 6.6 per 100 person-years .


In all subgroups , PrEP was protective against HIV-1 acquisition , with efficacy point estimates ranging from 64 to 84 % .


Among subgroups of women with placebo-arm HIV-1 incidence more than 5.0 , efficacy estimates ranged from 64 to 84 % .


Monthly visit attendance for PrEP refills and tenofovir detection in plasma were high .


Among higher-risk subgroups in the Partners PrEP Study , including groups solely of higher-risk women , both TDF alone and combined FTC/TDF PrEP had consistently high efficacy for HIV-1 protection .


PrEP , when used with high adherence , is a highly effective prevention strategy for higher risk heterosexuals .


Prioritizing PrEP for persons at high risk of HIV-1 will maximize its prevention impact .


The anti-programmed-death-receptor-1 ( PD-1 ) antibody pembrolizumab has shown potent antitumour activity at different doses and schedules in patients with melanoma .


We compared the efficacy and safety of pembrolizumab at doses of 2 mg/kg and 10 mg/kg every 3 weeks in patients with ipilimumab-refractory advanced melanoma .


In an open-label , international , multicentre expansion cohort of a phase 1 trial , patients ( aged 18 years ) with advanced melanoma whose disease had progressed after at least two ipilimumab doses were randomly assigned with a computer-generated allocation schedule ( 1:1 final ratio ) to intravenous pembrolizumab at 2 mg/kg every 3 weeks or 10 mg/kg every 3 weeks until disease progression , intolerable toxicity , or consent withdrawal .


Primary endpoint was overall response rate ( ORR ) assessed with the Response Evaluation Criteria In Solid Tumors ( RECIST , version 1.1 ) by independent central review .


Analysis was done on the full-analysis set ( all treated patients with measurable disease at baseline ) .


This study is registered with ClinicalTrials.gov , number NCT01295827 .


173 patients received pembrolizumab 2 mg/kg ( n = 89 ) or 10 mg/kg ( n = 84 ) .


Median follow-up duration was 8 months .


ORR was 26 % at both doses -- 21 of 81 patients in the 2 mg/kg group and 20 of 76 in the 10 mg/kg group ( difference 0 % , 95 % CI -14 to 13 ; p = 096 ) .


Treatment was well tolerated , with similar safety profiles in the 2 mg/kg and 10 mg/kg groups and no drug-related deaths .


The most common drug-related adverse events of any grade in the 2 mg/kg and 10 mg/kg groups were fatigue ( 29 [ 33 % ] vs 31 [ 37 % ] ) , pruritus ( 23 [ 26 % ] vs 16 [ 19 % ] ) , and rash ( 16 [ 18 % ] vs 15 [ 18 % ] ) .


Grade 3 fatigue , reported in five ( 3 % ) patients in the 2 mg/kg pembrolizumab group , was the only drug-related grade 3 to 4 adverse event reported in more than one patient .


The results suggest that pembrolizumab at a dose of 2 mg/kg or 10 mg/kg every 3 weeks might be an effective treatment in patients for whom there are few effective treatment options .


Merck Sharp and Dohme .


The aim of this study was to analyze diurnal profiles of physical activity for community-dwelling adults aged 70 years and over , and to explore the moderating effect of sex , age , morbidity , mobility limitation , and season on physical activity throughout the day .


A sample of 149 primary health care patients ( mean age 79.5 5.2 years , 74.5 % females ) was included in the analyses .


Participants ' physical activity was measured on up to six consecutive days via Omron Walking Style Pro HJ-720IT-E2 pedometer .


Step count per day and per hour , and pedometer wear time were descriptively analyzed .


A repeated measures ANOVA with physical activity per hour as dependent variable was performed to analyze the moderating effect of sex , age , morbidity , mobility limitation , and season on diurnal profiles of physical activity .


The diurnal profile for the total sample and adjusted diurnal profiles for subgroups are presented .


Participants ' daily step count averaged 3280 1873 steps/day .


They wore the pedometer for 14.2 1.7 hours per day and walked on average 234 139 steps per hour .


With respect to diurnal profiles , there were two peaks at 10-11 AM ( mean [ 95 % - confidence interval ] : 382 [ 329-435 ] steps ) and at 3-4 pm ( 313 [ 261-365 ] steps ) interrupted by a period of lower activity with a low point at 1-2 pm ( 229 [ 190-268 ] steps ) .


A mobility limitation , defined by use of a cane or a rollator , had a significant moderating effect ( p = 0.0237 ) on diurnal physical activity .


This is the first study to explore pedometer-determined diurnal profiles of physical activity in chronically ill and mobility-limited older adults .


Prolonging periods of elevated physical activity in the afternoon while respecting individual daily routine and commitments could be one option for facilitating the integration of physical activity and for making it a habit in older adults ' daily lives .


The use of a walking aid seems to be an indicator for a quite low activity plateau during the second half of the day .


People who use walking aids should be motivated to increase their physical activity during afternoon ; this might help to increase the overall low physical activity level of this vulnerable subgroup of older adults .


We evaluated the endogenous glucose production ( EGP ) and glucose disposal rate ( GDR ) over a range of doses of basal insulin peglispro ( BIL ) and insulin glargine in healthy subjects .


This was a single-center , randomized , open-label , four-period , incomplete-block , crossover study conducted in eight healthy male subjects .


Subjects had 8-h euglycemic clamps performed with primed , continuous infusions of BIL ( 5.1 to 74.1 mU/min ) in three dosing periods and insulin glargine ( 20 or 30 mU/m ( 2 ) / min ) in a fourth period , targeted to achieve 50-100 % suppression of EGP .


D - [ 3 - ( 3 ) H ] glucose was infused to assess rates of glucose appearance and disappearance .


Mean BIL and insulin glargine concentrations ( targeted to reflect the differences in intrinsic affinities of the two basal insulins ) ranged from 824 to 11,400 and 212 to 290 pmol/L , respectively , and increased accordingly with increases in dose .


Suppression of EGP and stimulation of GDR were observed with increasing concentrations of both insulins .


At insulin concentrations where EGP was significantly suppressed , insulin glargine resulted in increased GDR .


In contrast , at comparable suppression of EGP , BIL had minimal effect on GDR at lower doses and had substantially less effect on GDR than insulin glargine at higher doses .


The novel basal insulin analog BIL has relative hepatopreferential action and decreased peripheral action , compared with insulin glargine , in healthy subjects .


The consequences of alcohol dependence are severe and may range from physical disease to neuropsychological deficits in several cognitive domains .


Alcohol abuse has also been related to brain dysfunction specifically in the prefrontal cortex .


Conventional neuropsychological interventions ( paper-and-pencil cognitive stimulation training ) have a positive effect but are time-consuming , costly , and not motivating for patients .


Our goal was to test the cognitive effects of a novel approach to neuropsychological intervention , using mobile technology and serious games , on patients with alcohol dependence .


The trial design consisted of a two-arm study assessing the cognitive outcomes of neuropsychological intervention with mobile serious games ( mHealth ) versus control ( treatment-as-usual with no neuropsychological intervention ) in patients undergoing treatment for alcohol dependence syndrome .


Sixty-eight patients were recruited from an alcohol-rehab clinic and randomly assigned to the mHealth ( n = 33 ) or control condition ( n = 35 ) .


The intervention on the experimental group consisted of a therapist-assisted cognitive stimulation therapy for 4 weeks on a 2-3 days/week basis .


Fourteen patients dropped out of the study .


The results of the neuropsychological assessments with the remaining 54 patients showed an overall increase ( P < .05 ) of general cognitive abilities , mental flexibility , psychomotor processing speed , and attentional ability in both experimental ( n = 26 ) and control groups ( n = 28 ) .


However , there was a more pronounced improvement ( P = .01 ) specifically in frontal lobe functions from baseline ( mean 13.89 , SE 0.58 ) to follow-up ( mean 15.50 , SE 0.46 ) in the experimental group but not in the control group .


The overall increase in general cognitive function for both experimental and control groups supports the beneficial role of existing alcohol treatment protocols aimed at minimizing withdrawal symptoms , but the differential improvements observed in frontal lobe functioning supports the use of mobile serious games for neuropsychological stimulation to overcome executive dysfunction in patients with alcohol dependence .


This trial was negative on two neuropsychological/cognitive tests , and positive on one .


ClinicalTrials.gov NCT01942954 ; http://www.clinicaltrials.gov/ct2/show/NCT01942954 .


To assess the efficacy of oral transmucosal meloxicam for pain relief in lambs at marking .


A blinded , placebo-controlled , randomised , block design field study of 60 Merino lambs aged 7-10 weeks allocated to placebo and meloxicam treatments and studied in two cohorts of 30 .


Placebo-treated lambs received 1mL/10kg of drug vehicle and meloxicam-treated lambs received 1mg/kg meloxicam at 10mg/mL .


Treatments were administered into the buccal cavity immediately before knife castration and hot-iron tail docking .


Lambs were then released into a grassed paddock ( 0.34 ha ) .


Time to mother-up was recorded and behaviours were observed every 15min for 8h and again for 45min at 24h .


The sequence in which lambs exited the paddock with their mothers was then recorded .


Weight change and wound scores were recorded 4 and 7 days after marking .


Meloxicam did not affect mothering-up .


In the 8h following marking , meloxicam led to a 7-fold reduction ( P < 0.001 ) in combined abnormal behaviours ( hunched standing , standing with a stretched posture , walking stiffly ) .


The meloxicam group spent significantly less time in standing postures and tended to spend more time grazing , suckling and in normal lying postures .


At 24h , the meloxicam group spent more time lying and less time standing .


There was no effect of treatments on the sequence in which lambs moved into a fresh paddock or on weight change .


The buccal meloxicam formulation provided substantial analgesia to lambs on the day of marking .


Slight benefits were evident the following morning .


Coronary artery bypass grafting success is limited by vein graft failure ( VGF ) .


Understanding the factors associated with VGF may improve patient outcomes .


We examined 1828 participants in the Project of Ex Vivo Vein Graft Engineering via Transfection IV ( PREVENT IV ) trial undergoing protocol-mandated follow-up angiography 12 to 18 months post-coronary artery bypass grafting or earlier clinically driven angiography .


Outcomes included patient - and graft-level angiographic VGF ( 75 % stenosis or occlusion ) .


Variables were selected by using Fast False Selection Rate methodology .


We examined relationships between variables and VGF in patient - and graft-level models by using logistic regression without and with generalized estimating equations .


At 12 to 18 months post-coronary artery bypass grafting , 782 of 1828 ( 42.8 % ) patients had VGF , and 1096 of 4343 ( 25.2 % ) vein grafts had failed .


Demographic and clinical characteristics were similar between patients with and without VGF , although VGF patients had longer surgical times , worse target artery quality , longer graft length , and they more frequently underwent endoscopic vein harvesting .


After multivariable adjustment , longer surgical duration ( odds ratio per 10-minute increase , 1.05 ; 95 % confidence interval , 1.03-1 .07 ) , endoscopic vein harvesting ( odds ratio , 1.41 ; 95 % confidence interval , 1.16-1 .71 ) , poor target artery quality ( odds ratio , 1.43 ; 95 % confidence interval , 1.11-1 .84 ) , and postoperative use of clopidogrel or ticlopidine ( odds ratio , 1.35 ; 95 % confidence interval , 1.07-1 .69 ) were associated with patient-level VGF .


The predicted likelihood of VGF in the graft-level model ranged from 12.1 % to 63.6 % .


VGF is common and associated with patient and surgical factors .


These findings may help identify patients with risk factors for VGF and inform the development of interventions to reduce VGF .


http://www.clinicaltrials.gov .


Unique identifier : NCT00042081 .


The insulin secretion/insulin resistance ( IR ) ( disposition ) index ( I/G IR , where is change from baseline , I is insulin , and G is glucose ) is commonly used as a measure of - cell function .


This relationship is curvilinear and becomes linear when log transformed .


I is determined by 2 variables : insulin secretion rate ( ISR ) and metabolic clearance of insulin .


We postulated that the characteristic curvilinear relationship would be lost if plasma C-peptide ( CP ) ( instead of plasma insulin ) was plotted against insulin sensitivity .


A total of 441 individuals with impaired glucose tolerance ( IGT ) from ACT NOW received an oral glucose tolerance test and were randomized to pioglitazone or placebo for 2.4 years .


Pioglitazone reduced IGT conversion to diabetes by 72 % ( P < .0001 ) .


I/G vs the Matsuda index of insulin sensitivity showed the characteristic curvilinear relationship .


However , when CP/G or ISR/G was plotted against the Matsuda index , the curvilinear relationship was completely lost .


This discordance was explained by 2 distinct physiologic effects that altered plasma insulin response in opposite directions : 1 ) increased ISR and 2 ) augmented metabolic clearance of insulin .


The net result was a decline in the plasma insulin response to hyperglycemia during the oral glucose tolerance test .


These findings demonstrate a physiologic control mechanism wherein the increase in ISR ensures adequate insulin delivery into the portal circulation to suppress hepatic glucose production while delivering a reduced but sufficient amount of insulin to peripheral tissues to maintain the pioglitazone-mediated improvement in insulin sensitivity without excessive hyperinsulinemia .


These results demonstrate the validity of the disposition index when relating the plasma insulin response to insulin sensitivity but underscore the pitfall of this index when drawing conclusions about - cell function , because insulin secretion declined despite an increase in the plasma insulin response .


The aim of this study is to ascertain the subsequent radiobiological impact of using a consensus guideline target volume delineation atlas .


Using a representative case and target volume delineation instructions derived from a proposed IMRT rectal cancer clinical trial , gross tumor volume ( GTV ) and clinical/planning target volumes ( CTV/PTV ) were contoured by 13 physician observers ( Phase 1 ) .


The observers were then randomly assigned to follow ( atlas ) or not-follow ( control ) a consensus guideline/atlas for anorectal cancers , and instructed to re-contour the same case ( Phase 2 ) .


The atlas group was found to have increased tumor control probability ( TCP ) after the atlas intervention for both the CTV ( p < 0.0001 ) and PTV1 ( p = 0.0011 ) with decreasing normal tissue complication probability ( NTCP ) for small intestine , while the control group did not .


Additionally , the atlas group had reduced variance in TCP for all target volumes and reduced variance in NTCP for the bowel .


In Phase 2 , the atlas group had increased TCP relative to the control for CTV ( p = 0.03 ) .


Visual atlas and consensus treatment guideline usage in the development of rectal cancer IMRT treatment plans reduced the inter-observer radiobiological variation , with clinically relevant TCP alteration for CTV and PTV volumes .


This study aims to compare the clinical outcomes and costs between endoscopic biliary stenting ( EBS ) and percutaneous transhepatic biliary stenting ( PTBS ) .


We randomly assigned 112 patients with unresectable malignant biliary obstruction 2006 and 2011 to receive EBS or PTBS with self-expandable metal stent ( SEMS ) as palliative treatment .


PTBS was successfully performed in 55 patients who formed the PTBS group ( failed in 2 patients ) .


EBS was successfully performed in 52 patients who formed the EBS group ( failed in 3 patients ) .


The effectiveness of biliary drainage , hospital stay , complications , cost , survival time and mortality were compared .


Patients in PTBS group had shorter hospital stay and lower initial and overall expense than the BBS group ( P < 0.05 ) .


There was no significant difference in effectiveness of biliary drainage ( P = 0.9357 ) or survival time between two groups ( P = 0.6733 ) .


Early complications occurred in PTBS group was significantly lower than in EBS group ( 3/55 vs 11/52 , P = 0.0343 ) .


Late complications in the EBS group did not differ significantly from PTBS group ( 7/55 vs 9/52 , P = 0.6922 ) .


The survival curves in the two groups showed no significant difference ( P = 0.5294 ) .


Conclusions : 3 .


Rheumatoid arthritis ( RA ) is an inflammatory autoimmune disease in which the gut microbiota is altered .


Probiotics are microorganisms that can normalize gut microbiota ; thus , they may help to alleviate RA symptoms .


The objective of the present clinical trial was to assess the effects of probiotic supplementation on disease activity and inflammatory cytokines in patients with RA .


Forty-six patients with RA were assigned into two groups in this randomized , double-blind , placebo-controlled clinical trial .


The patients in the probiotic group received a daily capsule that contained a minimum of 10 ( 8 ) colony-forming units of Lactobacillus casei 01 for 8 wk .


The placebo group took capsules filled with maltodextrin for the same time period .


Questionnaires , anthropometric measurements , and fasting blood samples were collected , and the participants were assessed by a rheumatologist at baseline and at the end of the trial .


Disease activity score was significantly decreased by the intervention , and there was a significant difference between the two groups at the end of the study ( P < 0.01 ) .


Three of the assessed serum proinflammatory cytokines ( tumor necrosis factor - , interleukin-6 , and interleukin-12 ) significantly decreased in the probiotic group ( P < 0.05 ) ; however , serum levels of interleukin-1 were not significantly affected by the probiotic ( P = 0.22 ) .


The serum level of regulatory cytokine ( interleukin-10 ) was increased by the supplementation ( P < 0.05 ) .


The proportion of interleukin-10 to interleukin-12 was significantly increased in the probiotic group as well .


L. casei 01 supplementation improved the disease activity and inflammatory status of patients with RA .


Further studies are warranted to confirm these results , and such confirmation may lead to the introduction of probiotics as adjunctive therapy for this population .


Small birth size , often associated with insufficient maternal nutrition , contributes to a large share of global child undernutrition , morbidity , and mortality .


We developed a small-quantity lipid-based nutrient supplement ( SQ-LNS ) to enrich the diets of pregnant women .


The objective was to test a hypothesis that home fortification of pregnant women 's diets with SQ-LNS would increase birth size in an African community .


We enrolled 1391 women with uncomplicated pregnancies ( < 20 gestational weeks ) in a randomized controlled trial in Malawi .


The women were provided with one daily iron-folic acid ( IFA ) capsule , one capsule containing multiple micronutrients ( MMNs ) , or one 20-g sachet of SQ-LNS ( LNS , containing 118 kcal , protein , carbohydrates , essential fatty acids , and 21 micronutrients ) .


Primary outcomes were birth weight and newborn length .


Secondary outcomes included newborn weight , head and arm circumference , and pregnancy duration .


Analysis was by intention to treat .


The mean SD birth weight and newborn length were 2948 432 , 2964 460 , and 3000 447 g ( P = 0.258 ) and 49.5 2.4 , 49.7 2.2 , and 49.9 2.1 cm ( P = 0.104 ) in the IFA , MMN , and LNS groups , respectively .


For newborn weight-for-age , head circumference , and arm circumference , the point estimate for the mean was also highest in the LNS group , intermediate in the MMN group , and lowest in the IFA group , but except for midupper arm circumference ( P = 0.024 ) , the differences were not statistically significant .


The prevalence of low birth weight ( < 2500 g ) was 12.7 % , 13.5 % , and 12.1 % ( P = 0.856 ) , respectively ; newborn stunting ( length-for-age z score < -2 ) was 19.2 % , 14.0 % , and 14.9 % ( P = 0.130 ) , respectively ; and newborn small head circumference ( head circumference-for-age z score < -2 ) was 5.8 % , 3.0 % , and 3.1 % ( P = 0.099 ) , respectively .


The associations between the intervention and the outcomes were not modified by maternal parity , age , or nutritional status ( P > 0.100 ) .


The study findings do not support a hypothesis that provision of SQ-LNS to all pregnant women would increase the mean birth size in rural Malawi .


The trial was registered at clinicaltrials.gov as NCT01239693 .


Obesity impairs cognition and health-related quality of life ( HRQOL ) in older adults ; however , the appropriate treatment of obese older adults remains controversial .


The objective was to determine the independent and combined effects of weight loss and exercise on cognition , mood , and HRQOL in obese older adults .


One hundred seven frail , obese older adults were randomly assigned to a control , weight-management ( diet ) , exercise , or weight-management-plus-exercise ( diet-exercise ) group for 1 y.


In this secondary analysis , main outcomes were Modified Mini-Mental State Examination ( 3MS ) and total Impact of Weight on Quality of Life-Lite ( IWQOL ) scores .


Other outcomes included Word Fluency Test , Trail Making Test Parts A and B , and Geriatric Depression Scale ( GDS ) scores .


Scores on the 3MS improved more in the diet ( mean SE : 1.7 0.4 ) , exercise ( 2.8 0.4 ) , and diet-exercise ( 2.9 0.4 ) groups than in the control group ( 0.1 0.4 ) ( between-group P = 0.0001-0 .04 ) ; scores in the diet-exercise group improved more than in the diet group but not more than in the exercise group .


Scores on the Word Fluency Test improved more in the exercise ( 4.1 0.8 ) and diet-exercise ( 4.2 0.7 ) groups than in the control group ( -0.8 0.8 ; both P = 0.001 ) .


For the Trail Making Test Part A , scores in the diet-exercise group ( -11.8 1.9 ) improved more than in the control group ( -0.8 1.9 ) ( P = 0.001 ) ; a similar finding was observed for the Trail Making Test Part B. Scores on the IWQOL improved more in the diet ( 7.6 1.6 ) , exercise ( 10.1 1.6 ) , and diet-exercise ( 14.0 1.4 ) groups than in the control group ( 0.3 1.6 ) ( P = 0.0001-0 .03 ) ; scores in the diet-exercise group improved more than in the diet group but not more than in the exercise group .


In the diet-exercise group , peak oxygen consumption and strength changes were independent predictors of 3MS changes ; weight and strength changes were independent predictors of IWQOL changes .


GDS scores did not change .


Weight loss and exercise each improve cognition and HRQOL , but their combination may provide benefits similar to exercise alone .


These findings could inform practice guidelines with regard to optimal treatment strategies for obese older adults .


This trial was registered atclinicaltrials.govas NCT00146107 .


The purpose of this study was to determine whether contrast-enhanced sonography can improve the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas of the pancreas compared to conventional ( unenhanced ) sonography alone .


Between March 2008 and May 2012 , there were 20 patients with branch duct intraductal mucinous neoplasms and 25 with serous cystadenomas in our institute , for whom preoperative conventional and contrast-enhanced sonographic results were available .


The final diagnosis was obtained by histopathology .


Various conventional and contrast-enhanced sonographic characteristics were retrospectively evaluated by 2 radiologists in consensus .


A receiver operating characteristic curve analysis was used to evaluate the diagnostic value of conventional and contrast-enhanced sonography for discriminating between the two entities .


Three conventional sonographic characteristics ( microcysts , cysts with internal echoes , and main pancreatic duct dilatation ) and 2 contrast-enhanced sonographic characteristics ( communication between the lesion and main pancreatic duct and enhancement of mural nodules ) significantly improved the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas .


The area under the receiver operating characteristic curve increased from 0.691 with conventional sonography to 0.859 with combined contrast-enhanced and conventional ultrasonography ( P = .043 ) .


In this series of patients , the addition of contrast-enhanced sonography to conventional sonography improved the ability to differentiate branch duct intraductal mucinous neoplasms from serous cystadenomas .


To test the hypothesis that an initial fraction of inspired oxygen ( FiO2 ) of 30 % during resuscitation of preterm infants results in less oxidative stress and is associated with improved clinical outcomes compared with an FiO2 of 65 % .


Preterm infants of gestational age < 32 weeks ( n = 193 ) were randomized to start resuscitation with either 30 % oxygen ( low-oxygen group ) or 65 % oxygen ( high-oxygen group ) , after which the FiO2 was adjusted based on oxygen saturation values .


The primary outcome was bronchopulmonary dysplasia ( BPD ) assessed at 36 weeks postmenstrual age .


Secondary outcomes included major neonatal illnesses and markers of oxidative stress .


The median gestational age of included infants was 28 ( 6 ) / 7 weeks ( IQR , 26 ( 5 ) / 7-30 ( 3 ) / 7 weeks ) .


The incidence of BPD was not significantly different between the low-oxygen and high-oxygen groups ( 24 % vs. 17 % ; P = .15 ) .


The FiO2 in both groups was adjusted to a mean of 40 % by 7 minutes in the low-oxygen group and by 11 minutes in the high-oxygen group .


No differences in markers of oxidative stress were noted between groups .


Initial supplementation of preterm infants with 30 % oxygen during the fetal-to-neonatal transition is as safe as 65 % oxygen , with no differences in oxidative stress markers or BPD .


To compare immediate surgery to scaling and root planing ( SRP ) in the treatment of advanced periodontal disease focusing on the prevalence of residual sites and cost-effectiveness ( 1 ) ; to evaluate the adjunctive effects of azithromycin in a second treatment phase ( 2 ) .


Thirty-nine patients ( 18 males , 21 females ; mean age : 54.6 ) received oral hygiene instructions and were randomly allocated to surgery ( n = 19 ) or SRP ( n = 20 ) .


Patients with residual pockets ( 6mm ) at 6months received re-debridement of these sites and systemic azithromycin .


Treatment groups were followed up to 12months and evaluated in terms of clinical response parameters and cost-effectiveness .


Chair-time was used to assess the financial impact of treatment .


Both treatment arms were equally effective in terms of clinical outcome demonstrating less than 1 % residual pockets at 12months .


Surgery imposed an extra 746 Euro on the patient up to 6months when compared to SRP .


At 12months , 46 Euro of this amount could be offset as a result of a reduced need for supportive care .


Only 6 patients in the surgery group needed systemic antibiotics , whereas 14 patients in the SRP needed such additional treatment .


Although 700 Euro could be saved on average by performing SRP instead of surgery , the latter significantly reduced the need for supportive care and systemic antibiotics .


Elective interval appendectomy ( IA ) is traditionally advocated for the management of appendiceal mass ( AM ) in children .


Surgeons have debated the evidence and ` risks ' vs. ` benefits ' to support IA .


There are currently no randomised controlled trials and guiding best practice and financial costings for IA are lacking .


We herein report clinical outcomes , patient benefits and tariff charges linked with the provision of IA at a regional UK paediatric surgical centre .


Hospital case records of patients with AM were identified using pathology records and hospital admission codes during a 15-year period ( 1997-2011 ) .


Tariff costs ( Sterling ) were calculated for all admissions during the era 2007-2011 .


69 children were admitted with AM ( 61 % female , median age 10.5 years , range 2.1-16 years ) .


Median initial hospital stay with resolution of symptoms was 8 days ( range 3-14 days ) .


61 children ( 88 % ) had elective IA ( median interval 76 days , range 29-230 days ) .


Eight ( 12 % ) patients required emergency readmission for early appendectomy ( median interval 21 days , range 6-51 days ) .


Hospital stay for emergency readmission appendectomy in these children was significantly longer than IA ( median 6 vs. 3 days , p < 0.01 ) .


Laparoscopic appendectomy vs. ` open ' appendectomy was associated with shorter length of stay in the IA cohort ( median 3 vs. 2 days p < 0.01 ) .


No intra-operative morbidity was recorded in the study with only a single case developing a post-operative wound infection .


Median cost for IA was 1,936 .


Costings were higher in the emergency appendectomy group-2 ,171 vs. 1,936 ; p = 0.09 , NS .


Only 12 % of children at this centre develop recurrent appendicitis after primary admission with AM .


Interval and emergency appendectomy were associated with low morbidity .


Parents should be informed that IA may be ` non essential ' surgery .


Paediatric surgeons not routinely advocating IA can potentially save the NHS 1,936 per patient .


Future randomised studies are warranted to confirm or refute these findings .


This in situ study assessed the effects of adhesive systems containing or not fluoride and/or the antibacterial monomer 12-methacryloyloxydodecylpyridinium bromide ( MDPB ) on the microbiological composition of dental biofilm and enamel demineralization .


During two phases of 14 days , ten volunteers wore intraoral palatal appliances containing two slabs of human enamel according to a double-blind , crossover design .


The slabs were randomly restored using a composite resin and one of the following adhesive systems : All-Bond SE ( TM ) ( self-etch , fluoride/MDPB free adhesive , AB ) and Clearfl Protect Bond ( self-etch containing fluoride and MDPB adhesive , CB ) .


The biofilm formed on the slabs was analyzed with regard to total and mutans streptococci and lactobacilli counts .


Demineralization represented by integrated area of hardness lesion depth Delta S ( S ) was determined on enamel by analysis of cross-sectional microhardness , at 20 and 70 m from the restoration margin .


Data were analyzed by ANOVA .


No statistically significant difference was found either in enamel demineralization or in the microbiological composition of dental biofilm .


All adhesive systems containing or not fluoride and/or MDPB tested were unable to inhibit secondary caries in the in situ model used in the present research .


This pilot study compared the effects of lexical-semantic stimulation through telecommunication technology ( LSS-tele ) with in-person LSS ( LSS-direct ) and unstructured cognitive treatment ( UCS ) in patients with early Alzheimer 's disease .


Twenty-seven patients with Alzheimer 's disease in the very early stage ( Mini-Mental State Examination [ MMSE ] > 26/30 ) were divided into three groups : seven patients received LSS-tele treatment , ten received standard LSS-direct intervention , and ten participants underwent UCS as control condition .


Intervention treatments consisted of two weekly sessions of LSS ( through teleconference or face to face depending on group assignment ) or UCS exercises administered to small groups throughout a 3-month period .


The main outcome measures were changes of global cognitive performance , language abilities , and memory function .


Secondary outcome measures were changes in attention , working memory , executive functions , and visual-spatial abilities tests .


The mean MMSE score improved significantly in LSS-tele and LSS-direct treatments ; LSS-tele improved language abilities , both phonemic and semantic , and stabilized delayed verbal episodic memory with respect to an improved performance after the LSS-direct intervention and to a memory decline observed in the control group .


Improvement was not achieved in any neuropsychological test score after UCS .


Clinical application of telecommunication technology to cognitive rehabilitation of elderly patients with neurodegenerative cognitive impairment is feasible and may improve global cognitive performance .


Technical aspects to ameliorate efficacy of delivery may further improve its impact on domain-specific cognitive abilities .


Activation of TRPM8 and TRPA1 receptors generates cold and cold pain sensations , respectively , and is presumably important in clinical pain manifestations , such as cold hyperalgesia .


This study investigated the interaction between TRPM8 and TRPA1 receptors through stimulation of glabrous human skin ( volar forearm ) by topical administration of 40 % L-menthol and 10 % trans-cinnamaldehyde ( CA ) , individually and in combination .


Sensory manifestations were assessed in 10 healthy volunteers via a platform of 11 quantitative sensory ( thermal and mechanical stimuli ) and vasomotor tests ( skin temperature , perfusion and axon-reflex-flare ) in a double-blinded randomized crossover design .


Cold pain threshold was increased ( p < 0.01 , cold allodynia ) by L-menthol alone and L-menthol + CA in combination but unaffected by CA .


Mechanical pain threshold was significantly decreased ( mechanical hyperalgesia ) by all three substances ( p < 0.01 ) , with a significant intergroup difference found between CA alone and the less decreased L-menthol + CA ( p < 0.05 ) .


Application of CA alone and L-menthol + CA in combination showed an increase in skin temperature and perfusion significantly larger than that induced by L-menthol alone ( p < 0.05 ) .


An axon-reflex-flare was present after CA administration , but was significantly reduced upon addition of L-menthol ( p < 0.01 ) .


This study elucidates the potential of L-menthol as a counter-irritant to secondary neurogenic inflammation and provides evidence of an intricate interplay between cold receptors TRPA1 and TRPM8 , warranting further investigation of the neural coding of cold pain perception .


The Placement of Aortic Transcatheter Valves ( PARTNER ) trial reported a reduced rate of mortality in patients with previous coronary bypass grafting ( CABG ) operation who received surgical aortic valve replacement ( SAVR ) in comparison with transcatheter aortic valve replacement ( TAVR ) .


We sought to further evaluate these groups .


We reviewed the database of the 699 patients enrolled in the PARTNER trial .


The cohort for this study consisted of 288 patients ( 41.2 % ) who had a history of CABG operation before enrollment in the PARTNER trial .


All patients were followed up for 2 years .


The mean age was 81.56.6 years , and 231 patients ( 80.2 % ) were men .


The preoperative characteristics were similar in 140 patients ( 48.6 % ) who received SAVR and 148 ( 51.4 % ) who received TAVR .


There were no differences between the two groups with respect to the operative outcomes of death , stroke , and myocardial infarction , but the TAVR patients experienced more paravalvular regurgitation ( p < 0.0001 ) .


At 2 years , there was a trend toward greater all-cause mortality in the TAVR patients ( hazard ratio [ HR ] 1.53 ; 95 % confidence interval [ CI ] : 0.99 , 2.35 ; p = 0.052 ) .


Furthermore , the TAVR patients had more repeated hospitalization ( HR 1.75 ; 95 % CI : 0.99 , 3.07 ; p = 0.05 ) , death of any cause or repeated hospitalization ( HR 1.52 ; 95 % CI : 1.06 , 2.19 ; p = 0.02 ) , and death of any cause or stroke ( HR 1.51 ; 95 % CI : 1.00 , 2.27 ; p = 0.05 ) .


The 2-year follow-up of patients with a history of previous CABG operation in the PARTNER trial demonstrated improved outcomes with SAVR in comparison with TAVR .


Further longitudinal assessment is necessary to corroborate these findings and to understand the possible causes .


To determine influenza ( flu ) vaccination status among the mentally ill population and identify factors associated with vaccination status .


A non-interventional , cross-sectional study was conducted .


A self-administered survey to investigate the vaccination status and perceptions related to flu vaccine was administered between October 2011-January 2012 in an outpatient psychiatry clinic that served the indigent , severely mentally ill population of Alabama .


All statistical analyses were based upon a significance level of 0.05 .


Of the 736 patients invited , 302 participated ( 41 % ) .


Only 28.4 % were vaccinated in 2010-2011 and 24.2 % had been vaccinated at the time of the survey for 2011-2012 .


Respondents who had private health insurance , received a recommendation from healthcare providers , and who perceived a greater degree of vaccine effectiveness were more likely to obtain flu vaccination while respondents who had education beyond high school and were more in agreement that they can get the flu from the vaccine were less likely to obtain flu vaccination .


All of the above factors accounted for 26.7 % of vaccination decisions .


The flu vaccination rate among this study 's population was lower than the general population .


Interventions targeting the above factors should help increase vaccination rates among the mentally ill population .


To compare two embryo grouping strategies .


Retrospective time-course analysis in two different centres .


Two culture protocols were used at the zygote stage : `` Random Group '' in which zygotes were randomly grouped and `` Definite Group '' in which zygotes were grouped based on pronuclear pattern .


Embryo culture was extended to blastocyst stage .


Primary and secondary outcomes were respectively the blastulation rate and the cumulative clinical pregnancy and implantation rates .


A similar blastulation rate [ 42 and 41 % day ( 5 +6 ) blastocysts ] was obtained in the two groups .


Conversely , after adjusting for baseline and cycle variables , cumulative pregnancy [ adjusted Odds Ratio = 2.10 ( 95 % CI : 1.08-4 .07 ) ] and implantation [ adjusted Odds Ratio = 1.78 ( 95 % CI : 1.06-2 .97 ) ] rates were significantly higher in the `` Random Group '' compared to the `` Definite Group '' .


Two strategies of group culture gave similar results in terms of blastulation rate but the random grouping of zygotes improves pregnancy and implantation rates in IVF-cycles .


Endogenous pain modulation has been studied with the conditioned pain modulation ( CPM ) paradigm with large differences in the magnitude of the CPM effect .


We hypothesized that differences in CPM effects might be associated with differences in blood pressure responses to the conditioning stimulus when comparing the CPM effects using two different conditioning stimuli .


A single-blind repeated-measures design with block-randomization was applied on 25 healthy male subjects .


The test stimulus ( TS ; tonic heat pain for 120s ) was first presented alone , thereafter in parallel with a conditioning stimulus ( CS ) .


Conditioning stimuli were either a cold pressor test ( CPT ) or equally painful ischaemic muscle pain ( ISC ) , both lasting 120s .


Finger blood pressure and heart rate were recorded continuously .


Data were analysed in a linear mixed model framework with CS type ( CPT or ISC ) and conditioning ( TS or TS+CS ) as independent factors .


An inhibitory CPM effect was found for both types of conditioning ( p < 0.001 ) .


The CPM effect was larger during CPT conditioning compared with ISC conditioning ( p = 0.001 ) .


No association with the concomitant cardiovascular response ( blood pressure and heart rate ) was found ( p > 0.34 ) .


Cold pressor pain CS induces larger CPM effects than ischaemic pain CS .


The larger CPM effect is , however , not associated with a larger blood pressure response .


Other factors related to the CS should be investigated to understand why different CS modalities give different CPM effects .


A principal justification for the use of high-fidelity ( HF ) simulation is that , because it is closer to reality , students will be more motivated to learn and , consequently , will be better able to transfer their learning to real patients .


However , the increased authenticity is accompanied by greater complexity , which may reduce learning , and variability in the presentation of a condition on an HF simulator is typically restricted .


This study was conducted to explore the effectiveness of HF and low-fidelity ( LF ) simulation for learning within the clinical education and practice domains of cardiac and respiratory auscultation and physical assessment skills .


Senior-level nursing students were randomised to HF and LF instruction groups or to a control group .


Primary outcome measures included LF ( digital sounds on a computer ) and HF ( human patient simulator ) auscultation tests of cardiac and respiratory sounds , as well as observer-rated performances in simulated clinical scenarios .


On the LF auscultation test , the LF group consistently demonstrated performance comparable or superior to that of the HF group , and both were superior to the performance of the control group .


For both HF outcome measures , there was no significant difference in performance between the HF and LF instruction groups .


The results from this study suggest that highly contextualised learning environments may not be uniformly advantageous for instruction and may lead to ineffective learning by increasing extraneous cognitive load in novice learners .


Research in acute illness often requires an exception from informed consent .


Few studies have assessed the views of patients enrolled in exception from informed consent trials .


This study was designed to assess the views of patients and their surrogates of exception from informed consent enrollment within the context of a randomized , placebo-controlled trial of an investigational agent for traumatic brain injury .


Interactive interview study .


Nested within the Progesterone for the Treatment of Traumatic Brain Injury trial , a Phase III randomized controlled trial in acute traumatic brain injury .


Patients and surrogates ( for patients incapable of being interviewed ) enrolled in Progesterone for the Treatment of Traumatic Brain Injury under exception from informed consent at 12 sites .


None .


Interviews focused on respondents ' acceptance of exception from informed consent enrollment in Progesterone for the Treatment of Traumatic Brain Injury , use of placebo and randomization , understanding of major study elements , and views regarding regulatory protections .


Descriptive statistical analysis was performed ; textual data were analyzed thematically .


Eighty-five individuals were interviewed .


Eighty-four percent had positive attitudes toward Progesterone for the Treatment of Traumatic Brain Injury inclusion .


Seventy-eight percent found their inclusion under exception from informed consent acceptable , and 72 % found use of exception from informed consent in Progesterone for the Treatment of Traumatic Brain Injury acceptable in general .


Only two respondents clearly disagreed with both personal and general exception from informed consent enrollment .


The most common concerns ( 26 % ) related to absence of consent .


Eighty percent and 92 % were accepting of placebo use and randomization , respectively .


Although there were few black respondents ( n = 11 ) , they were less accepting of personal exception from informed consent enrollment than white respondents ( 55 % vs 83 % ; p = 0.0494 ) .


Acceptance of exception from informed consent in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants .


Exception from informed consent enrollment appears generally consistent with patients ' preferences .


Fluoroscopy is the routine method for localizing left ventricular ( LV ) and right ventricular ( RV ) lead positions in cardiac resynchronization therapy ( CRT ) .


However , the ability of fluoroscopy to determine lead positions in a standard ventricular segmentation is unknown .


We aimed to evaluate the accuracy and reproducibility of fluoroscopy to determine LV and RV lead positions in CRT when compared with cardiac computed tomography ( CT ) .


Fifty-nine patients undergoing CRT were included .


Bi-plane fluoroscopy and cardiac CT were evaluated in all patients .


Pacing lead positions were assessed in a standard LV 16-segment model and in a simplistic RV 8-segment model .


Four patients with LV lead displacement were excluded from the agreement analysis of LV lead position .


Agreement of LV lead position between fluoroscopy and cardiac CT was observed in 19 ( 35 % ) patients with fluoroscopy demonstrating a 1-segment and 2-segment error in 30 ( 55 % ) and 6 ( 11 % ) patients , respectively .


Agreement of RV lead position was found in 13 ( 22 % ) patients with fluoroscopy showing a 1-segment and 2-segment error in 28 ( 47 % ) and 18 ( 31 % ) patients , respectively .


The interobserver agreement on LV and RV lead positions was poor for fluoroscopy ( kappa 0.20 and 0.23 , respectively ) and excellent for cardiac CT ( kappa 0.87 and 0.85 , respectively ) .


Fluoroscopy is inaccurate and modestly reproducible when assessing LV and RV lead positions in a standard ventricular segmentation when compared with cardiac CT. .


Cardiac CT should be applied to determine the exact pacing site in future research evaluating the optimal pacing lead position in CRT .


To observe the safety and efficacy of early oral enteral nutrition after colorectal cancer operation .


A total of 88 colorectal cancer patients in our department from March 2013 to December 2013 were prospectively enrolled in the study and randomly divided into early enteral nutrition group ( 43 cases , receiving early water and enteral nutrition after operation ) and early fasting group ( 45 cases , receiving conventional postoperative care protocol ) based on the random number table .


The postoperative recovery , complication morbidity , nutritional status and stress were compared between the two groups .


Compared to early fasting group , patients in early enteral nutrition group had a significantly shorter duration of postoperative fever [ ( 53.75.9 ) h vs. ( 64.55.8 ) h , P < 0.01 ] , a shorter interval to flatus [ ( 57.58.2 ) h vs. ( 71.87.2 ) h , P < 0.01 ] , a shorter hospital stay [ ( 6.91.4 ) d vs. ( 8.51.9 ) d , P < 0.01 ] and lower medical cost [ ( 41 8683168 ) Yuan vs. ( 45 9503714 ) Yuan , P < 0.01 ] .


There was no significant difference in complication morbidity between the two groups [ 18.6 % ( 8/43 ) vs. 22.2 % ( 10/45 ) , P > 0.05 ] .


The albumin , prealbumin , and retinol binding protein on the third and seventh postoperative days were significantly higher in early oral enteral nutrition group ( P < 0.05 ) , while the rest energy expense ( REE ) and lnHOMA-IR were significantly lower as compared to early fasting group ( all P < 0.05 ) .


Early oral enteral nutrition after colorectal cancer operation is safe and effective , which is a natural route of nutrition and can reduce the stress response related to surgery , improve postoperative patients ' nutritional status and accelerate rehabilitation .


Enhanced reduction of multinodular goiter ( MNG ) can be achieved by stimulation with recombinant human thyrotropin ( rhTSH ) before radioiodine ( ( 131 ) I ) therapy .


The objective was to compare the long-term efficacy and safety of two low doses of modified release rhTSH ( MRrhTSH ) in combination with ( 131 ) I therapy .


In this phase II , single-blinded , placebo-controlled study , 95 patients ( 57.2 9.6 years old , 85 % women , 83 % Caucasians ) with MNG ( median size 96.0 mL ; range 31.9-242 .2 mL ) were randomized to receive placebo ( n = 32 ) , 0.01 mg MRrhTSH ( n = 30 ) , or 0.03 mg MRrhTSH ( n = 33 ) 24 hours before a calculated ( 131 ) I activity .


Thyroid volume ( TV ) and smallest cross-sectional area of trachea ( SCAT ) were measured ( by computed tomography scan ) at baseline , six months , and 36 months .


Thyroid function and quality of life ( QoL ) was evaluated at three-month and yearly intervals respectively .


At six months , TV reduction was enhanced in the 0.03 mg MRrhTSH group ( 32.9 % vs. 23.1 % in the placebo group ; p = 0.03 ) but not in the 0.01 mg MRrhTSH group .


At 36 months , the mean percent TV reduction from baseline was 44 12.7 % ( SD ) in the placebo group , 41 21.0 % in the 0.01 mg MRrhTSH group , and 53 18.6 % in the 0.03 mg MRrhTSH group , with no statistically significant differences among the groups , p = 0.105 .


In the 0.03 mg MRrhTSH group , the subset of patients with basal ( 131 ) I uptake < 20 % had a 24 % greater TV reduction at 36 months than the corresponding subset of patients in the placebo group ( p = 0.01 ) .


At 36 months , the largest relative increase in SCAT was observed in the 0.03 mg MRrhTSH group ( 13.4 23.2 % ) , but this was not statistically different from the increases observed in the placebo or the 0.01 mg MRrhTSH group ( p = 0.15 ) .


Goiter-related symptoms were reduced and QoL improved , without any enhanced benefit from using MRrhTSH .


At three years , the prevalence of permanent hypothyroidism was 13 % , 33 % , and 45 % in the placebo , 0.01 mg , and 0.03 mg MRrhTSH groups respectively .


The overall safety profile of the study was favorable .


When used as adjuvant to ( 131 ) I , enhanced MNG reduction could not be demonstrated with MRrhTSH doses 0.03 mg , indicating that the lower threshold for efficacy is around this level .


Intervention of medical clowns ( MC ) during various medical procedures performed in children has been used to relieve anxiety and pain .


Their role in allergy skin testing has never been evaluated .


To evaluate whether MC can diminish pain and anxiety perceived by children undergoing allergy skin prick tests ( SPT ) .


In a prospective , randomized , controlled , and blinded study , children undergoing SPT were or were not accompanied by MC .


All parents and children 8years completed the State-Trait Anxiety Inventory ( STAI ) before and after SPT .


Videotapes recorded during the procedure were scored for anxiety ( m-YPAS ) for all children and for pain ( FLACC ) for children 2-7years old by a psychologist who was unaware of the MC 's presence .


After SPT , children 8years completed a visual analog score ( VAS ) for pain .


Ninety-one children ( mean age 8.2 years , M/F = 54/37 ) were recruited of whom 45 were accompanied by clowns .


A significant reduction in state-STAI was found in the clowns group , in both parents and children , when compared with the regular group ( 26.96.6 and 32.310.0 ; P = 0.004 , and 27.14.2 and 34.37.6 ; P = 0.002 , respectively ) .


Both m-YPAS and FLACC were reduced in the clowns group compared with the regular one .


In the clowns group , m-YPAS positively correlated with both VAS and FLACC ( P = 0.000 and 0.002 , respectively ) .


m-YPAS was positively correlated with FLACC in the regular group ( P = 0.000 ) .


Medical clowns significantly decrease the level of anxiety perceived by both children undergoing allergy SPT and their parents , as well as the pain perceived by young children .


An immune-enhancing diet has been used to alter eicosanoid synthesis , cytokine production , and immune function in an attempt to limit the undesired immune reactions after injury from surgery .


This prospective randomized study was designed to investigate the effect of preoperative immunonutrition on operative complications , and the participation of prostaglandin E2 ( PGE2 ) on T-cell differentiation in patients undergoing a severely stressful surgery .


The enrolled patients who were scheduled to undergo pancreatoduodenectomy were randomized into two groups .


Patients in the immunonutrition group ( n = 25 ) received oral supplementation containing arginine , -3 fatty acids , and RNA for 5 days before the procedure in addition to a 50 % reduction in the amount of regular food .


Patients in the control group ( n = 25 ) received no artificial nutrition and were allowed to consume regular food before surgery .


All patients received early postoperative enteral infusion of a standard formula intended to provide 25 kcal/kg/day .


The primary endpoint was the rate of infectious complications ; the secondary endpoint was immune responses .


This study is registered with ClinicalTrials.gov ( NCT01256034 ) .


Infectious complication rate and severity of complications ( Clavien-Dindo classification ) were lesser in the immunonutrition group than in the control group .