In order to meet the patients wish for compensation of presbyopia in a flexible way , even in cases of an already pseudophacic eye , sulcus-fixated additional intraocular lenses ( IOL ) have been developed as an alternative to multifocal IOLs ( MIOL ) in the capsular bag .


This allows subsequent application of multifocal optics .


Furthermore , these additional lenses offer a relatively simple opportunity for postoperative refractive fine tuning or , in cases of incompatibility , a minimally invasive explantation of the multifocal part of the optical system .


The objective of our work was the examination of a diffractive multifocal additional IOL and its functional characteristics .


In a prospective , monocentric trial 32 eyes of 21 patients had cataract surgery with implantation of a monofocal IOL into the capsular bag and simultaneous implantation of a multifocal additional IOL into the sulcus .


The visual acuity was tested at different distances 6 weeks and 3 months postoperatively .


At the 3 month follow-up contrast sensitivity and defocus curves were additionally assessed .


Patients with bilateral implantation filled in a questionnaire to assess their subjective satisfaction of postoperative visual quality .


All eyes had an uneventful postoperative course .


At both follow-ups an uncorrected distance and near visual acuity ( VA ) of 0.2 LogMAR or better was achieved .


In intermediate vision 29 out of 32 eyes after 6 weeks and 31 out of 32 eyes after 3 months reached an uncorrected VA of 0.2 LogMAR or better .


The defocus curves showed a typical two-peaked shape .


At intermediate distance ( -1.5 D of defocus ) the median VA was 0.35 LogMAR .


Contrast sensitivity testing showed results in the upper region of the standard range of age-matched , healthy patients .


The examined type of diffractive additional IOL achieved good to very good functional results , which are comparable to corresponding IOLs in the capsular bag .


Multifocal additional IOLs can be considered as a useful extension of refractive surgical alternatives for the compensation of presbyopia .


The possibility to implant the multifocal optic part independently of the primary surgery , the minimal invasivity of the procedure and the likewise time-independent reversibility can be pointed out as special qualities of these IOL .


Clinical trials suggest that statins have beneficial effects on the cardiovascular system independent from their cholesterol lowering properties .


In patients with chronic kidney disease stage II-III , we tested the hypothesis that atorvastatin increased systemic and renal nitric oxide ( NO ) availability using L-N ( G ) - monomethyl arginine ( L-NMMA ) as an inhibitor of NO production .


In a randomized , placebo-controlled , crossover study patients were treated with atorvastatin for 5 days with standardized diet and fluid intake .


Glomerular filtration reate ( GFR ) , fractional excretions of sodium ( FENa ) , urinary excretion of aquaporin-2 ( u-AQP2 ) and epithelial sodium channels ( u-ENaC ) , vasoactive hormones ( renin , angiotensin II , aldosterone , arginine vasopressin , endothelin-1 and brain natriuretic peptide ) and central blood pressure ( BP ) estimated by applanation tonometry were measured before and after systemic administration of the NO inhibitor L-NMMA .


Atorvastatin caused a significant reduction in U-ENaC , but sodium excretion , C H 2 O , FENa and u-AQP2 were not changed by atorvastatin .


L-NMMA reduced renal effect variables , including GFR , FENa and u-ENaC and increased brachial BP and central BP to a similar extent during both treatments .


Vasoactive hormones were changed in the same way by L-NMMA during atorvastatin and placebo treatment .


During , atorvastatin and placebo treatment , inhibition of nitric oxide synthesis induced the same response in brachial and central blood pressure , GFR , renal tubular function and vasoactive hormones .


Thus , the data do not support that atorvastatin changes nitric oxide availability in patients with mild nephropathy .


The reduced u-ENaC may reflect changes in sodium absorption in the nephron induced by atorvastatin .


The aim of the study is to present a comparison of short-term results of double - versus single-bundle anatomical reconstruction of the anterior cruciate ligament ( ACL ) using hamstring endons and their fixation with absorbable interference screws .


A total of 110 patients with an isolated ACL lesion and the healthy contralateral knee who met the indication criteria for ACL double bundle reconstruction ( TISL , 14 mm ; ICNW , 12 mm ) were intra-operatively allocated at random to either double-bundle group ( DB , n = 55 ) or single-bundle group ( SB , n = 55 ) .


At 12 months after surgery , 97 patients ( DB group , n = 49 ; SB group , n = 48 ) , comprising 68 men and 29 women , were evaluated ; the average age was 29.1 years and the injury-to-surgery interval was 15.9 weeks .


Pre - and post-operative subjective criteria involved the IKDC and Lysholm score .


Objectively , the occurrence of graft failure , range of motion deficit , return to pre-injury sports activity , side-to-side difference in anterior laxity of both knees in 20 flexion on a GNRB laximeter at an applied pressure of 124 N and 250 N , and pivot shift phenomenon were assessed .


No statistically significant difference was found in pre-operative values between the two groups .


Post-operatively , there were no significant differences in the occurrence of complete graft failure ( p = 0.0755 ; DB group , n = 0 ; SB group , n = 3 ) , range-of-motion deficit ( p = 0.2277-0 .9788 ) or return to pre-operative sports activity ( p = 0.2322 ) .


In the DB group , side-to-side anterior tibial shifts at a pressure of 124 N ( medians = 1.3 mm and 2.1 mm for DB and SB groups , respectively ; p = 0.0007 ) and at a pressure of 250 N ( DB group = 2.1 mm ; SB group = 3.1 mm ; p < 0.0001 ) were significantly different from the corresponding values in the SB group .


Positive results for the pivot shift test ( PST ) were significantly less frequent in the DB than the SB group ( Chi-square test = 0.0112 ) .


The SB group patients had a 2.9-times ( odds ratio , 2.8704 ) higher risk of positive postoperative PST results than the DB group patients .


In both groups , a comparison of pre - and post-operative criteria showed significant improvement in both the subjective and the objective results .


The results of this study , in accordance with other authors ' conclusions , suggest that the double-bundle technique provides better control over rotational and anterior knee laxity and therefore restores knee biomechanics better .


However , other literature data do not confirm any significantly better outcomes of this method .


Since only short-term results have been obtained so far , the study will continue because only the long-term results can provide conclusive evidence of an advantage of one technique over the other .


Our study showed significantly better restoration of knee rotational and anterior laxity in the patients undergoing anatomical reconstruction of the ACL by the double-bundle technique .


The other evaluated criteria did not differ in relation to the technique used .


Increased blood pressure ( BP ) is commonly observed in patients treated with vascular endothelial growth factor pathway inhibitors , including axitinib .


Ambulatory BP monitoring ( ABPM ) and pharmacokinetic data were collected in a randomised , double-blind phase II study of axitinib with or without dose titration in previously untreated patients with metastatic renal cell carcinoma .


Aims of these analyses were to ( 1 ) develop a population pharmacokinetic-pharmacodynamic model for describing the relationship between axitinib exposure and changes in diastolic BP ( dBP ) and ( 2 ) simulate changes in dBP with different axitinib dosing regimens .


We employed a three-stage modelling approach , which included development of ( 1 ) a baseline 24-h ABPM model , ( 2 ) a pharmacokinetic model from serial and sparse pharmacokinetic data , and ( 3 ) an indirect-response , maximum-effect ( Emax ) model to evaluate the exposure-driven effect of axitinib on dBP .


Simulations ( N = 1,000 ) were performed using the final pharmacokinetic-pharmacodynamic model to evaluate dBP changes on days 4 and 15 of treatment with different axitinib doses .


Baseline ABPM data from 62 patients were best described by 24-h mean dBP and two cosine terms .


The final indirect-response Emax model showed good agreement between observed 24-h ABPM data and population and individual predictions .


The maximum increase in dBP was 20.8 % , and the axitinib concentration at which 50 % of the maximal increase in dBP was reached was 12.4 ng/mL .


Our model adequately describes the relationship between axitinib exposure and dBP increases .


Results from these analyses may potentially be applied to infer dBP changes in patients administered axitinib at nonstandard doses .


To compare risk-adjusted differences between men and women 30 and 60 days after hip fracture surgery in not walking , ability to return home in a community-dwelling subset , not walking in a nursing home resident subset , and mortality within 60 days .


Cohort study .


Data were from a randomized clinical trial that compared two blood transfusion protocols after hip fracture .


Individuals with hip fracture ( N = 2,016 ; 489 ( 24 % ) male ) .


Walking , dwelling , and mortality were determined in telephone follow-up 30 and 60 days after randomization , which occurred within 3 days of surgery .


Sex differences for each outcome were compared using univariate and multivariate regression adjusting for potential confounders .


Men were younger ( P < .001 ) and more likely to have comorbidity ( P = .003 ) than women at the time of hip fracture and to die within 60 days , even after risk adjustment ( odds ratio ( OR ) = 1.76 , 95 % confidence interval ( CI ) = 1.15-2 .69 ) .


After risk adjustment , male survivors were as likely as female survivors not to walk ( OR = 1.03 , 95 % CI = 0.78-1 .34 ) and no less likely to return home ( OR = 0.90 , 95 % CI = 0.69-1 .17 ) 60 days after hip fracture .


No differences were noted between male and female nursing home residents in not walking within 60 days ( OR = 0.95 , 95 % CI = 0.32-2 .86 ) .


Although men experience higher mortality , male survivors can expect recovery of walking ability similar to that of female survivors and are as likely to return to community living .


A single subanesthetic infusion of the N-methyl-D-aspartate ( NMDA ) receptor antagonist ketamine has rapid and potent antidepressant properties in treatment-resistant major depressive disorder ( TRD ) .


As a family history of an alcohol use disorder is a positive predictor of ketamine 's antidepressant response and the strength of the association increases over time , we hypothesized that depressed subjects with a family history of an alcohol use disorder would have greater antidepressant durability and that riluzole would augment and/or extend ketamine 's antidepressant efficacy .


Fifty-two TRD subjects received an open-label infusion of ketamine ( 0.5 mg/kg over 40 minutes ) , and , four to six hours post-infusion , were randomized to either flexible-dose ( 100-200mg / day ) riluzole or placebo in the following proportions : Family History Positive ( FHP ) riluzole ( n = 10 ) , FHP placebo ( n = 9 ) , Family History Negative ( FHN ) riluzole ( n = 16 ) , and FHN placebo ( n = 17 ) .


FHP subjects randomized to placebo had a greater antidepressant response than FHN subjects ; however , contrary to our initial hypothesis , there was no significant difference in antidepressant efficacy with riluzole .


Although potentially underpowered , there was no difference in overall time-to-relapse based on randomization status ( riluzole responders : n = 15 , placebo responders : n = 17 ) .


Yet , time-to-relapse was longer in FHP placebo responders ( n = 8 ) compared to FHN placebo responders ( n = 9 ) with , again , no significant difference in time-to-relapse in FHP riluzole responders ( n = 6 ) compared to FHN riluzole responders ( n = 9 ) .


Ketamine 's extended antidepressant durability in FHP TRD should be considered in the design and analysis of ketamine depression trials .


To investigate the effect of combination therapy of backward walking training and alpha-lipoic acid ( ALA ) treatment on the distribution of plantar pressure in patients with diabetic peripheral neuropathy ( DPN ) .


This study is a double-blinded , randomized controlled trial .


The test group was treated with combination therapy of backward walking exercise and ALA ( ALA for 2wk , backward walking exercise for 12wk ) , and the control group only received ALA treatment .


Clinical and laboratory setting .


Patients with DPN ( N = 60 ) were divided into the test group ( n = 30 ) or control group ( n = 30 ) .


Backward walking exercise with ALA treatment for the test group ; lipoic acid treatment for the control group .


Plantar pressure before and after treatment was tested and analyzed with the flatbed plantar pressure measurement system .


After treatment , peak plantar pressure in the forefoot dropped for both the test and control groups ; peak plantar pressure for the test group dropped significantly .


Peak plantar pressure in the medial foot slightly increased for the test group , suggesting a more even distribution of plantar pressure in the test group after treatment .


The combination therapy of ALA and backward walking proved to be more effective than ALA monotherapy .


Backward walking also proved to have an ameliorating effect on balance ability and muscle strength of patients with DPN .


Hypertrophic resistance exercise ( HRE ) induces central and peripheral fatigue .


However , more detailed information about changes in corticospinal excitability remains to be elucidated .


Eleven volunteers participated in the upper arm HRE which included one repetition maximum ( 1 RM ) control contractions and three sets of 13 RM ( SET1-3 ) .


Transcranial magnetic stimulation ( TMS ) was applied during maximal isometric voluntary contraction ( MVC ) at the end of each set and during control contractions to study changes in corticospinal excitability .


Electrical stimulation was used in order to measure peripheral changes .


MVC decreased after each set when compared to control contractions .


Motor evoked potential ( MEP ) were 138.752.7 % ( p < 0.05 ) , 130.444.7 and 113.131.4 % after SET1 , SET2 and SET3 , respectively , when compared to pre-exercise value .


A significant reduction in MEP area between SET1 and SET3 ( p < 0.05 ) was observed while silent period ( SP ) duration increased ( ~ 151-165ms , p < 0.05 ) simultaneously between these sets .


TMS-evoked twitch force during MVC increased significantly following each set when compared to pre-exercise value .


Simultaneously , a significant reduction was observed in resting twitch force over the sets .


The results of this study clearly support the existence of both central and peripheral fatigue during HRE of elbow flexors .


However , changes in the MEP area and SP suggest that during HRE of the elbow flexors , the corticospinal excitability increases first , until at some point , supraspinal fatigue takes over .


Actinic keratosis therapy can elicit unsightly and painful local skin responses ; assessment of treatment satisfaction and health-related quality of life ( QoL ) is important .


Ingenol mebutate gel is a novel topical field therapy for actinic keratosis .


Post-hoc analyses were performed based on patient-reported outcomes from phase-III trials ( n = 1005 ) to assess the effects of ingenol mebutate on QoL and the relationship between both QoL and treatment satisfaction , and degree of lesion clearance .


Patients received ingenol mebutate or vehicle for self-application to a 25-cm ( 2 ) contiguous area : 0.015 % once daily for 3 consecutive days ( face/scalp ) or 0.05 % once daily for 2 consecutive days ( trunk/extremities ) .


QoL ( Skindex-16 ) and Treatment Satisfaction Questionnaire for Medication data were recorded .


Significant , positive associations between Treatment Satisfaction Questionnaire for Medication score and degree of clearance were identified for patients in the face/scalp ( effectiveness P < .0001 and global satisfaction P = .0002 ) and trunk/extremities ( P < .0001 and P = .0014 , respectively ) groups .


There was a significant association between Skindex-16 score and clearance for patients in the face/scalp group for change in symptoms ( P = .0218 ) , emotions ( P = .0002 ) , and overall Skindex-16 score ( P = .0006 ) from baseline .


Clinical trial population findings may not be generalizable to clinical practice .


Ingenol mebutate significantly improved patients ' QoL and treatment satisfaction .


Improvements were associated with higher degrees of actinic keratosis lesion clearance .


Left ventricular ( LV ) twist may be a compensatory mechanism to preserve ejection fraction ( EF ) .


In patients with hypertension , twist varies depending on the left ventricle 's degree of remodeling and systolic function ; it is increased in those with hypertension with normal EF ( HTNEF ) and diminished in those with hypertension with low EF ( HTLEF ) .


The ratio of collagen-degradation biomarkers in patients with hypertension is higher in those with low EFs than those with preserved EFs and may contribute to remodeling and systolic dysfunction .


The aim of this study was to evaluate the relationship between these biomarkers and LV twist in 82 patients with hypertension , 41 with EFs < 50 % ( HTLEF group ) and 41 with EFs 50 % ( HTNEF group ) .


Net LV twist was measured using speckle-tracking echocardiography .


Markers of collagen turnover , including serum concentrations of matrix metalloproteinase-1 ( MMP1 ) , tissue inhibitor of MMP1 ( TIMP1 ) , and the ratio of MMP1 to TIMP1 , were measured .


Log TIMP1 , log MMP1 , and log MMP1/TIMP1 ratio levels were higher in the HTLEF group than the HTNEF group ( 12.3 0.3 vs 11.8 0.1 [ P < .0001 ] , 9.1 0.3 vs 8.0 0.2 [ P < .0001 ] , and -3.3 0.3 vs -3.8 0.2 [ P < .0001 ] , respectively ) .


Net LV twist was lower in the HTLEF group than the HTNEF group ( 3.3 1.1 vs 11.7 0.7 , P < .0001 ) .


An inverse correlation existed between log MMP1/TIMP1 and net LV twist after adjusting for age , EF , duration of heart failure , systolic blood pressure , LV mass index , and LV sphericity index at end-diastole ( r = -0.43 , P < .0001 ) .


This inverse correlation between twist and loss of myocardial collagen scaffolding in patients with hypertension with heart failure suggests that the integrity of the extracellular matrix may play an important role in preserving myocardial deformation .


Treatment approaches for major depressive disorder ( MDD ) result in approximately one third of patients achieving remission after a first treatment .


Added treatment generally improves remission rates , but approximately one third of all patients fail to respond after several treatments ( sequential monotherapies or combined treatment ) .


A pretreatment biomarker could help identify these patients .


Overactivity of the subcallosal cingulate has been associated with failure of response to treatment in MDD , and it is a potential candidate for such a biomarker .


Investigators enrolled 82 patients with MDD currently not receiving treatment in a two-phase treatment study .


Patients underwent a fluorodeoxyglucose positron emission tomography scan .


After scanning , patients were randomly assigned to 12 weeks of treatment with either escitalopram or cognitive-behavioral therapy ( CBT ) .


Patients not achieving remission after 12 weeks of initial treatment were treated with an additional 12 weeks of escitalopram plus CBT .


Subcallosal cingulate metabolism was compared between patients who failed to achieve a response and patients who achieved remission as a result of either phase one or phase two treatment .


This analysis was followed by a whole-brain analysis making the same comparison .


After two phases of treatment ( 24 weeks ) , 36 patients were identified as remitters , 6 patients were responders , and 9 patients were nonresponders .


Subcallosal cingulate metabolism was significantly higher in nonresponders than remitters .


In the follow-up whole-brain analysis , increased superior temporal sulcus activity was also associated with nonresponse to two treatments .


Patients with MDD who fail to achieve remission as a result of CBT or escitalopram , either alone or in combination , have a distinct brain metabolic pattern compared with patients who achieve remission as a result of CBT , escitalopram , or their combination .


World Health Organization ( WHO ) recommends that the episiotomy rate should be around 10 % , which is already a reality in many European countries .


Currently the use of episiotomy should be restricted and physicians are encouraged to use their clinical judgment to decide when the procedure is necessary .


There is no clinical evidence corroborating any indication of episiotomy , so until the present moment it is not yet known whether episiotomy is indeed necessary in any context of obstetric practice .


To compare maternal and perinatal outcomes in women undergoing a protocol of not performing episiotomy versus selective episiotomy .


An open label randomized clinical trial will be conducted including laboring women with term pregnancy , maximum dilation of 8 cm , live fetus in cephalic vertex presentation .


Women with bleeding disorders of pregnancy , indication for caesarean section and those without capacity to consent and without legal guardians will be excluded .


Primary outcomes will be frequency of episiotomy , delivery duration , frequency of spontaneous lacerations and perineal trauma , frequency of instrumental delivery , postpartum blood loss , need for perineal suturing , number of sutures , Apgar scores at one and five minutes , need for neonatal resuscitation and pH in cord blood .


As secondary outcomes frequency complications of perineal suturing , postpartum perineal pain , maternal satisfaction , neonatal morbidity and admission newborn in NICU will be assessed .


Women will be invited to participate and those who agree will sign the consent form and will be then assigned to a protocol of not conducting episiotomy ( experimental group ) or to a group that episiotomy is performed selectively according to the judgment of the provider of care delivery ( control Group ) .


The present study was approved by IMIP 's Research Ethics Committee .


Clinical Trials Register under the number and was registered in ClinicalTrials.gov under the number NCT02178111 .


Secondhand smoke ( SHS ) is a significant cause of acute respiratory illness ( ARI ) and 5 times more common in indigenous children .


A single-blind randomized trial was undertaken to determine the efficacy of a family centered SHS intervention to reduce ARI in indigenous infants in Australia and New Zealand .


Indigenous mothers/infants from homes with 1 smoker were randomized to a SHS intervention involving 3 home visits in the first 3 months of the infants ' lives ( plus usual care ) or usual care .


The primary outcome was number of ARI-related visits to a health provider in the first year of life .


Secondary outcomes , assessed at 4 and 12 months of age , included ARI hospitalization rates and mothers ' report of infants ' SHS exposure ( validated by urinary cotinine/creatinine ratios [ CCRs ] ) , smoking restrictions , and smoking cessation .


Two hundred and ninety-three mother/infant dyads were randomized and followed up .


Three quarters of mothers smoked during pregnancy and two thirds were smoking at baseline ( as were their partners ) , with no change for more than 12 months .


Reported infant exposure to SHS was low ( 95 % had smoke-free homes/cars ) .


Infant CCRs were higher if one or both parents were smokers and if mothers breast fed their infants .


There was no effect of the intervention on ARI events [ 471 intervention vs. 438 usual care ( reference ) ; incidence rate ratio = 1.10 , 95 % confidence intervals ( CI ) = 0.88-1 .37 , p = .40 ] .


Despite reporting smoke-free homes/cars , mothers and their partners continue to smoke in the first year of infants ' lives , exposing them to SHS .


Emphasis needs to be placed on supporting parents to stop smoking preconception , during pregnancy , and postnatal .


Kangaroo care ( KC ) and maternal singing benefit preterm infants , and we investigated whether combining these benefitted infants and mothers .


A prospective randomised , within-subject , crossover , repeated-measures study design was used , with participants acting as their own controls .


We evaluated the heart rate variability ( HRV ) of stable preterm infants receiving KC , with and without maternal singing .


This included low frequency ( LF ) , high frequency ( HF ) and the LF/HF ratio during baseline ( 10min ) , singing or quiet phases ( 20min ) and recovery ( 10min ) .


Physiological parameters , maternal anxiety and the infants ' behavioural state were measured .


We included 86 stable preterm infants , with a postmenstrual age of 32-36weeks .


A significant change in LF and HF , and lower LF/HF ratio , was observed during KC with maternal singing during the intervention and recovery phases , compared with just KC and baseline ( all p-values < 0.05 ) .


Maternal anxiety was lower during singing than just KC ( p = 0.04 ) .


No differences in the infants ' behavioural states or physiological parameters were found , with or without singing .


Maternal singing during KC reduces maternal anxiety and leads to autonomic stability in stable preterm infants .


This effect is not detected in behavioural state or physiological parameters commonly used to monitor preterm infants .


Finerenone decreases albuminuria in patients having heart failure with reduced ejection fraction and mild-to-moderate ( stage 2-3 ) chronic kidney disease .


The MinerAlocorticoid Receptor Antagonist Tolerability Study-Diabetic Nephropathy ( ARTS-DN ; NCT01874431 ) is a multicenter , randomized , double-blind , placebo-controlled , parallel-group , phase 2b study .


ARTS-DN investigated whether the mineralocorticoid receptor antagonist finerenone reduces albuminuria without causing major alterations in serum potassium levels in patients with type 2 diabetes mellitus and a clinical diagnosis of DN who were receiving a renin-angiotensin-system ( RAS ) inhibitor .


Patients were randomized to oral finerenone 1.25-20 mg or placebo once daily .


The primary objectives were to assess the ratio of the urinary albumin-to-creatinine ratio at day 90 to that at baseline in patients receiving finerenone , and to compare it with that in the placebo group .


Additional exploratory analyses included evaluating changes from baseline in serum potassium levels , efficacy and safety biomarkers , and health-related quality of life .


Of 1,501 patients screened , 821 ( the sample population ) received at least one dose of finerenone/placebo .


Baseline characteristics included : male , 77.8 % ; white , 84.2 % ; very high albuminuria ( formerly macroalbuminuria ) , 38.4 % ; high albuminuria ( formerly microalbuminuria ) , 60.3 % ; median ( range ) estimated glomerular filtration rate , 66.3 ( 24.5-130 .7 ) ml/min/1 .73 m ( 2 ) ; and systolic blood pressure ( mean standard deviation ) , 138.1 14.4 mm Hg .


There was a history of cardiovascular disease in 39.6 % , diabetic neuropathy in 20.0 % , and diabetic retinopathy in 19.9 % of patients .


ARTS-DN is the first phase 2b trial of finerenone in combination with a RAS inhibitor in patients with type 2 diabetes mellitus and a clinical diagnosis of DN .


Postprandial elevation of triglycerides impairs endothelial function and contributes to the development of atherosclerosis .


We investigated the effects of omega-3 fatty acids on postprandial endothelial function and lipid profiles .


Healthy volunteers [ 10 ] were given supplementation at 4g/day omega-3 fatty acids ( or were not treated ) for 4 weeks in a randomised crossover study .


Postprandial levels of various lipids were monitored and endothelial function assessed by brachial artery flow-mediated dilation during fasting and after a standard cookie test .


Omega-3 fatty acids reduced postprandial endothelial dysfunction compared with the control diet ( flow-mediated dilation at 4h = -0.51.2 vs. -2.01.6 % , P = 0.03 ) .


Postprandial levels of triglycerides , apolipoprotein B-48 , and remnant lipoprotein-cholesterol increased in untreated subjects , peaked at 2-4h , and returned to baseline at 8h , whereas low-density lipoprotein-cholesterol levels did not change .


Supplementation with omega-3 fatty acids significantly suppressed postprandial elevation of triglycerides ( incremental area under the curve = 220209 vs. 374216mg/h/dL , P = 0.04 ) and remnant lipoprotein-cholesterol ( incremental area under the curve = 21.713.8 vs. 13.312.9 mg/h/dL , P = 0.04 ) .


Supplementation with omega-3 fatty acids significantly suppressed the increase in triglyceride content in chylomicrons as well as in very-low-density lipoproteins from baseline to 4h after the cookie test .


Omega-3 fatty acids significantly decreased postprandial triglyceride elevation and postprandial endothelial dysfunction , suggesting that omega-3 fatty acids may have vascular protective effects in postprandial state .


The beneficial results of a theory-practice pilot stress management program for Pharmacy and Biochemistry professionals and students .


Its importance as a complement of traditional academic education , as well as its potential for Pharmaceutical Care is also discussed .


A total of 27 students and 26 professionals took part in a program of 10 sessions , aimed at improving stress management .


Ten of the students and 10 professionals were randomly assigned to control groups .


Salivary cortisol levels and anxiety level tests before and after the program were used to assess efficacy .


Both the cortisol and the anxiety levels significantly decreased among students and professionals after the program , whereas it significantly increased in the student control group .


Anxiety levels significantly decreased in both students and professionals .


This type of pilot program proved effective for students .


In the case of health professionals , the sample size needs to be increased in order to achieve an acceptable level of statistical power .


Considering the shift of the pharmaceutical profession towards Pharmaceutical Care , the training of competences and attitudes like those described in this work could be of value .


This study aimed at comparing the effects of intermittent and repeated sprint ability training on physiological variables .


Sixteen young female basketball players were randomly allocated to intermittent training ( IT = 8 ) or repeated sprint ability training ( RST = 8 ) groups .


The following outcomes were measured at baseline and after 6 weeks of training : Yo-Yo intermittent recovery ( Yo-Yo ) and repeated sprint ability ( RSA ) tests .


For all the variables investigated the effect of training type showed a different trend respect at current knowledge .


In the RSA , best time ( BT ) was a significant main effect of training time ( pre - vs. post - ) ( P < 0.0001 ) , and of the interaction training type/time ( P = 0.03 ) .


The RST showed a decrease in BT of 3.1 % ( P = 0.005 ) while the IT showed a decrease of 6.2 % ( P < 0.0001 ) .


In the IT there was a significant main effect of time for the total distance with an increment of 26.9 % , and a significant main effect of time in the final speed with an increment of 1.23 % .


These findings suggest that the two training methods used in this study can be an effective training strategy for inducing anaerobic and basketball-specific training schedules .


Besides , even when IT training is not done at very high speed , it can increase the maximum speed of the RSA .


The purpose of this study was to differentiate perfusion and vascular characteristics between benign and malignant breast lesions by 3-dimensional contrast-enhanced sonography and evaluate their correlation with microvessel density and vascular endothelial growth factor ( VEGF ) expression for further clinical exploration .


Three-dimensional contrast-enhanced sonography was performed in 183 patients with breast lesions , and sonographic characteristics were carefully observed for further analysis .


The mean microvessel density and VEGF expression were measured by immunohistochemical analysis .


Pathologic results showed 35 benign and 148 malignant cases .


Malignancy and benignity differed significantly in peripheral vessel characteristics ( number , distribution , course , degree of dilatation , and penetrating vessels ) , rim perfusion and coarseness degree , intratumoral perfusion type , and intratumoral vessel dilatation ( P < .05 ) but not the presence of peripheral and intratumoral vessels and intratumoral perfusion ( P > .05 ) .


The specificity of penetrating vessels was 88.6 % for diagnosing malignancy .


The sensitivity , specificity , and accuracy of rim perfusion coarseness were 90.2 % , 70.4 % , and 85.3 % respectively .


The sensitivity of the intratumoral perfusion type was 77.8 % , whereas the specificity of intratumoral vessel dilatation was 88.9 % .


Microvessel density and VEGF expression were significantly correlated with perfusion and vascular characteristics ( P < .05 ) , except the presence of peripheral vessels , rim perfusion , and intratumoral perfusion ( P > .05 ) .


The presence of intratumoral vessels was related to VEGF ( P < .05 ) but not microvessel density ( P > .05 ) .


Three-dimensional contrast-enhanced sonographic characteristics were statistically different between benign and malignant breast lesions .


Some of them also correlated significantly with microvessel density and VEGF expression and therefore have potential for objective evaluation of tumor angiogenesis .


Dehydroepiandrosterone ( DHEA ) has been proposed to improve pregnancy rates in women with diminished ovarian reserve undergoing in vitro fertilisation ( IVF ) treatment .


However , evidence regarding its efficacy is supported by a limited number of randomised controlled trials ( RCTs ) .


This double-blinded RCT aims to measure the effect of DHEA supplementation prior to and during controlled ovarian hyperstimulation on ovarian response prior to IVF treatment in women predicted to have poor ovarian reserve .


Sixty women with ovarian antral follicle count 10 and serum anti-Mullerian hormone 5 pmol/L undergoing IVF/intracytoplasmic sperm injection ( ICSI ) treatment at the Nurture fertility clinic , Nottingham will be recruited .


They will be randomised to either receive DHEA capsule 75mg/day or placebo for at least 12weeks before egg collection .


All participants will undergo standard long down regulation protocol using human menopausal gonadotropin 300IU/day .


Serum samples and follicular fluids at the time of egg collection will be collected for hormonal immunoassays .


For ICSI participants , cumulus cells stripped from oocyte will be collected for cumulus gene expression analyses regarding oocyte competence .


Microdrops of oocyte culture media before the time of ICSI will be assessed for glucose , pyruvate and lactate utilisation .


Embryo transfer will be performed on day 2 , 3 or 5 based on the number and quality of the embryos available .


Pregnancy will be defined as urine pregnancy test positive ( biochemical pregnancy ) and 6-8weeks ultrasound scan with fetal heart beat ( clinical pregnancy ) and live birth .


It is planned to perform the molecular and nutritional fingerprint analyses in batches after finishing the clinical phase of the study .


The approval of the study was granted by the NHS Research Ethics Committee ( Ref number NRES 12/EM/0002 ) , the Medicines and Healthcare products Regulatory Agency ( MHRA ) , and the Nottingham University Hospitals Trust Research and Development department .


All participants shall provide written informed consent before being randomised into allocated treatment groups .


Protocol V. 2.0 ; EudraCT number : 2011-002425-21 ; http://www.clinicaltrials.gov; NCT01572025 ; CTA reference : 03057/0053/001 -0002 .


Diabetes mellitus ( DM ) is an independent risk factor for atrial fibrillation ( AF ) .


Increased atrial electromechanical delay ( AEMD ) is known to be a precursor of AF .


In this study , we aimed to investigate AEMD in patients with type 2 DM .


A total of 110 participants were recruited to the present study .


Of them , 70 were diabetic patients , and 40 were healthy control subjects .


Basal characteristics were recorded and transthoracic echocardiography was performed for all study participants .


Basal characteristics were similar between the two groups .


There was significant intra-atrial and interatrial electromechanical delay in the diabetic group compared with the control group .


In the correlation analysis , no correlation existed between AEMD and hemoglobin A1C or fasting plasma glucose levels .


In the present study , we showed that there was significant AEMD in patients with type 2 DM compared with healthy control subjects .


Increased AEMD might be an early marker of AF in this patient subset .


To clear this hypothesis , further studies are needed .


People with opioid dependence and HIV are concentrated within criminal justice settings ( CJS ) .


Upon release , however , drug relapse is common and contributes to poor HIV treatment outcomes , increased HIV transmission risk , reincarceration and mortality .


Extended-release naltrexone ( XR-NTX ) is an evidence-based treatment for opioid dependence , yet is not routinely available for CJS populations .


A randomized , double-blind , placebo-controlled trial of XR-NTX for HIV-infected inmates transitioning from correctional to community settings is underway to assess its impact on HIV and opioid-relapse outcomes .


We describe the methods and early acceptability of this trial .


In addition we provide protocol details to safely administer XR-NTX near community release and describe logistical implementation issues identified .


Study acceptability was modest , with 132 ( 66 % ) persons who consented to participate from 199 total referrals .


Overall , 79 % of the participants had previously received opioid agonist treatment before this incarceration .


Thus far , 65 ( 49 % ) of those agreeing to participate in the trial have initiated XR-NTX or placebo .


Of the 134 referred patients who ultimately did not receive a first injection , the main reasons included a preference for an alternative opioid agonist treatment ( 37 % ) , being ineligible ( 32 % ) , not yet released ( 10 % ) , and lost upon release before receiving their injection ( 14 % ) .


Study findings should provide high internal validity about HIV and opioid treatment outcomes for HIV-infected prisoners transitioning to the community .


The large number of patients who ultimately did not receive the study medication may raise external validity concerns due to XR-NTX acceptability and interest in opioid agonist treatments .


NCT01246401 .


There is an ongoing debate regarding the optimal criteria for return to sport after an acute hamstring injury .


Less than 10 % isokinetic strength deficit is generally recommended but this has never been documented in professional football players after rehabilitation .


Our aim was to evaluate isokinetic measurements in MRI-positive hamstring injuries .


Isokinetic measurements of professional football players were obtained after completing a standardised rehabilitation programme .


An isokinetic strength deficit of more than 10 % compared with the contralateral site was considered abnormal .


Reinjuries within 2months were recorded .


52 players had a complete set of isokinetic testing before clinical discharge .


There were 27 ( 52 % ) grade 1 and 25 ( 48 % ) grade 2 injuries .


35 of 52 players ( 67 % ) had at least one of the three hamstring-related isokinetic parameters that display a deficit of more than 10 % .


The percentage of players with 10 % deficit for hamstring concentric 60/s , 300/s and hamstring eccentric was respectively 39 % , 29 % and 28 % .


There was no significant difference of mean isokinetic peak torques and 10 % isokinetic deficits in players without reinjury ( N = 46 ) compared with players with reinjury ( N = 6 ) .


When compared with the uninjured leg , 67 % of the clinically recovered hamstring injuries showed at least one hamstring isokinetic testing deficit of more than 10 % .


Normalisation of isokinetic strength seems not to be a necessary result of the successful completion of a football-specific rehabilitation programme .


The possible association between isokinetic strength deficit and increased reinjury risk remains unknown .


Early detection of lung cancer is crucial as the prognosis depends on the disease stage .


Chest radiographs has been the principal diagnostic tool for general practitioners ( GPs ) , but implies a potential risk of false negative results , while computed tomography ( CT ) has a higher sensitivity .


The aim of this study was to describe the implementation of direct access to low-dose CT ( LDCT ) from general practice .


We conducted a cohort study nested in a randomised study .


A total of 119 general practices with 266 GPs were randomised into two groups .


Intervention GPs were offered direct access to chest LDCT combined with a Continuing Medical Education ( CME ) meeting on lung cancer diagnosis .


During a 19-month period , 648 patients were referred to LDCT ( 0.18 / 1000 adults on GP list/month ) .


Half of the patients needed further diagnostic work-up , and 15 ( 2.3 % , 95 % CI : 1.3-3 .8 % ) of the patients had lung cancer ; 60 % ( 95 % CI : 32.3-83 .7 % ) in a localised stage .


The GP referral rate was 61 % higher for CME participants compared to non-participants .


Of all patients referred to LDCT , 2.3 % were diagnosed with lung cancer with a favourable stage distribution .


Half of the referred patients needed additional diagnostic work-up .


There was an association between participation in CME and use of CT scan .


The proportion of cancers diagnosed through the usual fast-track evaluation was 2.2 times higher in the group of CME-participating GPs .


The question remains if primary care case-finding with LDCT is a better option for patients having signs and symptoms indicating lung cancer than a screening program .


Whether open access to LDCT may provide earlier diagnosis of lung cancer is yet unknown and a randomised trial is required to assess any effect on outcome .


Clinicaltrials.gov NCT01527214 .


Many patients with advanced type 2 diabetes do not meet their glycated haemoglobin targets and randomised controlled studies comparing the efficacy of pump treatment and multiple daily injections for lowering glucose in insulin-treated patients have yielded inconclusive results .


We aimed to resolve this uncertainty with a randomised controlled trial ( OpT2mise ) .


We did this multicentre , controlled trial at 36 hospitals , tertiary care centres , and referal centres in Canada , Europe , Israel , South Africa , and the USA .


Patients with type 2 diabetes who had poor glycaemic control despite multiple daily injections with insulin analogues were enrolled into a 2-month dose-optimisation run-in period .


After the run-in period , patients with glycated haemoglobin of 80-120 % ( 64-108 mmol/mol ) were randomly assigned ( 1:1 ) by a computer-generated randomisation sequence ( block size 2 with probability 075 and size 4 with probability 025 ) to pump treatment or to continue with multiple daily injections .


Neither patients nor investigators were masked to treatment allocation .


The primary endpoint was change in mean glycated haemoglobin between baseline and end of the randomised phase for the intention-to-treat population .


This study is registered with ClinicalTrials.gov , number NCT01182493 .


495 of 590 screened patients entered the run-in phase and 331 were randomised ( 168 to pump treatment , 163 to multiple daily injections ) .


Mean glycated haemoglobin at baseline was 9 % ( 75 mmol/mol ) in both groups .


At 6 months , mean glycated haemoglobin had decreased by 11 % ( SD 12 ; 12 mmol/mol , SD 13 ) in the pump treatment group and 04 % ( SD 11 ; 4 mmol/mol , SD 12 ) in the multiple daily injection group , resulting in a between-group treatment difference of -07 % ( 95 % CI -09 to -04 ; -8 mmol/mol , 95 % CI -10 to -4 , p < 00001 ) .


At the end of the study , the mean total daily insulin dose was 97 units ( SD 56 ) with pump treatment versus 122 units ( SD 68 ) for multiple daily injections ( p < 00001 ) , with no significant difference in bodyweight change between the two groups ( 15 kg [ SD 35 ] vs 11 kg [ 36 ] , p = 0322 ) .


Two diabetes-related serious adverse events ( hyperglycaemia or ketosis without acidosis ) resulting in hospital admission occurred in the pump treatment group compared with one in the multiple daily injection group .


No ketoacidosis occurred in either group and one episode of severe hypoglycaemia occurred in the multiple daily injection group .


In patients with poorly controlled type 2 diabetes despite using multiple daily injections of insulin , pump treatment can be considered as a safe and valuable treatment option .


Medtronic .


Colchicine is effective for the treatment of acute pericarditis and first recurrences .


However , conclusive data are lacking for the efficacy and safety of colchicine for treatment of multiple recurrences of pericarditis .


We did this multicentre , double-blind trial at four general hospitals in northern Italy .


Adult patients with multiple recurrences of pericarditis ( two ) were randomly assigned ( 1:1 ) to placebo or colchicine ( 05 mg twice daily for 6 months for patients weighing more than 70 kg or 05 mg once daily for patients weighing 70 kg or less ) in addition to conventional anti-inflammatory treatment with aspirin , ibuprofen , or indometacin .


Permuted block randomisation ( size four ) was done with a central computer-based automated sequence .


Patients and all investigators were masked to treatment allocation .


The primary outcome was recurrent pericarditis in the intention-to-treat population .


This trial is registered with ClinicalTrials.gov , number NCT00235079 .


240 patients were enrolled and 120 were assigned to each group .


The proportion of patients who had recurrent pericarditis was 26 ( 216 % ) of 120 in the colchicine group and 51 ( 425 % ) of 120 in the placebo group ( relative risk 049 ; 95 % CI 024-065 ; p = 00009 ; number needed to treat 5 ) .


Adverse effects and discontinuation of study drug occurred in much the same proportions in each group .


The most common adverse events were gastrointestinal intolerance ( nine patients in the colchicine group vs nine in the placebo group ) and hepatotoxicity ( three vs one ) .


No serious adverse events were reported .


Colchicine added to conventional anti-inflammatory treatment significantly reduced the rate of subsequent recurrences of pericarditis in patients with multiple recurrences .


Taken together with results from other randomised controlled trials , these findings suggest that colchicine should be probably regarded as a first-line treatment for either acute or recurrent pericarditis in the absence of contraindications or specific indications .


Azienda Sanitaria 3 of Torino ( now ASLTO2 ) .


Despite the increasing use of pre - and posthydration protocols and low-osmolar instead of high-osmolar iodine-containing contrast media , the incidence of contrast-induced nephropathy ( CIN ) is still significant .


There is evidence that contrast media cause ischemia-reperfusion injury of the medulla .


Remote ischemic preconditioning ( RIPC ) is a non-invasive , safe , and low-cost method to reduce ischemia-reperfusion injury .


The RIPCIN study is a multicenter , single-blinded , randomized controlled trial in which 76 patients at risk of CIN will receive standard hydration combined with RIPC or hydration with sham preconditioning .


RIPC will be applied by four cycles of 5min ischemia and 5min reperfusion of the forearm by inflating a blood pressure cuff at 50mmHg above the actual systolic pressure .


The primary outcome measure will be the change in serum creatinine from baseline to 48 to 72h after contrast administration .


A recent pilot study reported that RIPC reduced the incidence of CIN after coronary angioplasty .


The unusual high incidence of CIN in this study is of concern and limits its generalizability .


Therefore , we propose a randomized controlled trial to study whether RIPC reduces contrast-induced kidney injury in patients at risk for CIN according to the Dutch guidelines .


Current Controlled Trials ISRCTN76496973 .


To assess the long-term effects of nilvadipine on the progression of central visual field defect in retinitis pigmentosa ( RP ) .


Patients with RP were randomly divided into a treated group receiving oral nilvadipine and a control group .


Progression of RP was evaluated with MD slope and the average sensitivity of the central 2 ( CENT4 ) .


The mean MD slopes were -0.55 / -0.39 ( right/left eyes , n = 19 ) dB/year in the treated group and -1.37 / -1.15 ( right/left eyes , n = 22 ) dB/year in the control group ( P = 0.016 / 0.050 , resp . )


In both eyes , however , no statistical difference was observed between the two groups for the CENT4 values .


Although we confirmed that nilvadipine significantly retarded the progression of the average of MD value defects in the central 10 , it was not specific for the central 2 of the visual field in RP .


In Japan , combination therapy with high doses of antipsychotic drugs is common , but as a consequence , many patients with schizophrenia report extrapyramidal and autonomic nervous system side effects .


To resolve this , we proposed a method of safety correction of high dose antipsychotic polypharmacy ( the SCAP method ) , in which the initial total dose of all antipsychotic drugs is calculated and converted to a chlorpromazine equivalent ( expressed as milligrams of chlorpromazine , mg CP ) .


The doses of low-potency antipsychotic drugs are then reduced by 25 mg CP/week , and the doses of high-potency antipsychotics are decreased at a rate of 50 mg CP/week .


Although a randomized , case-controlled comparative study has demonstrated the safety of this method , the number of participants was relatively small and its results required further validation .


In this study of the SCAP method , we aimed to substantially increase the number of participants .


The participants were in - or outpatients treated with two or more antipsychotics at doses of 500-1 ,500 mg CP/day .


Consenting participants were randomized into control and dose reduction groups .


In the control group , patients continued with their normal regimen for 3 months without a dose change before undergoing the SCAP protocol .


The dose reduction group followed the SCAP strategy over 3-6 months with a subsequent 3-month follow-up period .


Outcome measures were measured at baseline and then at 3-month intervals , and included clinical symptoms measured on the Manchester scale , the extent of extrapyramidal and autonomic side effects , and quality of life using the Euro QOL scale .


We also measured blood drug concentrations and drug efficacy-associated biochemical parameters .


The Brief Assessment of Cognition in Schizophrenia , Japanese version , was also undertaken in centers where it was available .


The safety and efficacy of the SCAP method required further validation in a large randomized trial .


The design of this study aimed to address some of the limitations of the previous case-controlled study , to build a more robust evidence base to assist clinicians in their efforts to reduce potentially harmful polypharmacy in this vulnerable group of patients .


UMIN Clinical Trials Registry 000004511 .


To investigate the short-term cost-effectiveness of cognitive-behavioral therapy ( CBT ) and psychodynamic therapy ( PDT ) compared to waiting list ( WL ) .


The analysis was conducted alongside the SOPHO-NET multi-center efficacy trial .


Patients were randomly assigned to CBT ( n = 209 ) , PDT ( n = 207 ) , or WL ( n = 79 ) .


Resource use was assessed prior and during treatment to determine direct and absenteeism costs .


Unadjusted incremental cost-effectiveness ratios ( ICERs ) were calculated based on remission and response rates .


To visualize statistical uncertainty , cost-effectiveness acceptability curves ( CEACs ) were constructed based on adjusted net-benefit regression .


Different values for the societys willingness to pay ( WTP ) were assumed .


Both interventions were more efficacious than WL but were associated with increased direct costs besides intervention costs .


Unadjusted ICERs per responder were 3615 for CBT and 4958 for PDT .


Unadjusted ICERs per remitted patient were 5788 and 10,733 .


CEACs revealed a high degree of uncertainty : applying the 97.5 % probability threshold , CBT proved cost-effective at a WTP 16,100 per responder and 26,605 per remitted patient .


Regarding PDT cost-effectiveness only was certain for response at a WTP 27,290 .


The WL condition is assumed to represent untreated patients , although the expectation to start treatment in the near future probably affects symptom severity and health care utilization .


At the end of treatment cost-effectiveness of CBT and PDT compared to WL is uncertain and depends on the societal WTP .


The interventions may induce a more adequate utilization of other health care services - involving increased costs .


Development of costs and effects in the long-run should be considered .


Diarrhea 's impact on childhood morbidity can be reduced by administering oral rehydration solution ( ORS ) with zinc ; challenges to wider use are changing health-seeking behavior and ensuring access .


We conducted a randomized controlled trial to increase ORS plus zinc uptake in rural Myanmar .


Village tracts , matched in 52 pairs , were randomized to standard ORS access vs. a social franchising program training community educators and supplying ORS plus zinc .


Intervention and control communities were comparable on demographics , prevalence of diarrhea and previous use of ORS .


One year after randomization , ORS plus zinc use was 13.7 % in the most recent case of diarrhea in intervention households compared with 1.8 % in control households ( p < 0.001 ) ( N = 3605 ) .


A significant increase in ORS plus zinc use was noted in the intervention ( p = 0.044 ) but not in the control ( p = 0.315 ) group .


Social franchising increased optimal treatment of childhood diarrhea in rural Myanmar .


Scale-up stands to reduce morbidity among children in similar settings .


Current Controlled Trials ISRCTN73606238 .


Salsalate treatment has well-known effects on improving glycemia , and the objective of this study was to examine whether the mechanism of this effect was related to changes in adipose tissue .


A randomized double-blind and placebo-controlled trial in obese Hispanics ( 18-35 years ) was conducted .


The intervention consisted of 4 g day ( -1 ) of salsalate ( n = 11 ) versus placebo ( n = 13 ) for 4 weeks .


Outcome measures included glycemia , adiposity , ectopic fat , and adipose tissue gene expression and inflammation .


In those receiving salsalate , plasma fasting glucose decreased by 3.4 % ( P < 0.01 ) , free fatty acids decreased by 42.5 % ( P = 0.06 ) , and adiponectin increased by 27.7 % ( P < 0.01 ) .


Salsalate increased insulin AUC by 38 % ( P = 0.01 ) and HOMA-B by 47.2 % ( P < 0.01 ) while estimates of insulin sensitivity/resistance were unaffected .


These metabolic improvements occurred without changes in total , abdominal , visceral , or liver fat .


Plasma markers of inflammation/immune activation were unchanged following salsalate .


Salsalate had no effects on adipose tissue including adipocyte size , presence of crown-like structures , or gene expression of adipokines , immune cell markers , or cytokines downstream of NF-B with the exception of downregulation of IL-1 ( P < 0.01 ) .


Findings suggest that metabolic improvements in response to salsalate occurred without alterations in adiposity , ectopic fat , or adipose tissue gene expression and inflammation .


Providing e-learning modules can be an effective strategy for enhancing gatekeepers ' knowledge , self-confidence and skills in adolescent suicide prevention .


The aim of this study was to test the effectiveness of an online training program called Mental Health Online which consists of eight short e-learning modules , each capturing an important aspect of the process of recognition , guidance and referral of suicidal adolescents ( 12-20years ) .


The primary outcomes of this study are participant 's ratings on perceived knowledge , perceived self-confidence , and actual knowledge regarding adolescent suicidality .


A randomized controlled trial will be carried out among 154 gatekeepers .


After completing the first assessment ( pre-test ) , participants will be randomly assigned to either the experimental group or the waitlist control group .


One week after completing the first assessment the experimental group will have access to the website Mental Health Online containing the eight e-learning modules and additional information on adolescent suicide prevention .


Participants in both conditions will be assessed 4weeks after completing the first assessment ( post-test ) , and 12weeks after completing the post-test ( follow-up ) .


At post-test , participants from the experimental group are asked to complete an evaluation questionnaire on the modules .


The waitlist control group will have access to the modules and additional information on the website after completing the follow-up assessment .


Gatekeepers can benefit from e-learning modules on adolescent suicide prevention .


This approach allows them to learn about this sensitive subject at their own pace and from any given location , as long as they have access to the Internet .


Given the flexible nature of the program , each participant can compose his/her own training creating an instant customized course with the required steps in adolescent suicide prevention .


Netherlands Trial Register NTR3625 .


Researchers and participants ' expectations can influence treatment response .


Less is known about the effects of researchers ' expectations on the accuracy of data collection in the context of a weight loss trial .


Student raters ( N = 58 ; age = 20.12.3 years ) were recruited to weigh individuals who they thought were completing a 12-month weight loss trial , although these ` participants ' were actually standardized patients ( SPs ) playing these roles .


Prior to data collection , student raters were provided information suggesting that the tested treatment had been effective .


Each student rater received a list of 9-10 ` participants ' to weigh .


While the list identified each person as ` treatment ' or ` control ' , this assignment was at random , which allowed us to examine the effects of non-blinding and expectancy manipulation on weight measurement accuracy .


We hypothesized that raters would record the weights of ` treatment participants ' as lower than those of ` control participants ' .


Contrary to our hypothesis , raters recorded weights that were 0.293 kg heavier when weighing ` treatment ' vs. ` control ' SPs , although this difference was not significant ( P = 0.175 ) .


This pilot study found no evidence that manipulating expectancies about treatment efficacy or not blinding raters biased measurements .


Future work should examine other biases which may be created by not blinding research staff who implement weight loss trials as well as the participants in those trials .


To evaluate the efficacy and long-term safety of linagliptin added to basal insulin in Asian patients with type 2 diabetes mellitus ( T2DM ) inadequately controlled by basal insulin with/without oral agents .


This was a post hoc analysis of Asian patients from a global 52 week study in which patients on basal insulin were randomized ( 1:1 ) to double-blind treatment with linagliptin 5mg once daily or placebo ( NCT00954447 ) .


Basal insulin dose remained stable for 24 weeks , after which adjustments could be made according to the investigator 's discretion to improve glycemic control .


The primary endpoint was the mean change in glycated hemoglobin ( HbA1c ) from baseline to 24 weeks .


Data were available for 154 Asian patients ( 80 linagliptin , 74 placebo ) .


Baseline HbA1c ( standard deviation [ SD ] ) was 8.6 ( 0.9 ) % ( 70 [ 10 ] mmol/mol ) .


The placebo-corrected mean change ( standard error [ SE ] ) in HbA1c from baseline was -0.9 ( 0.1 ) % ( -10 [ 1 ] mmol/mol ) ( 95 % confidence interval [ CI ] : -1.2 , -0.7 ; p < 0.0001 ) at Week 24 and -0.9 ( 0.1 ) % ( -10 [ 1 ] mmol/mol ) ( 95 % CI : -1.1 , -0.6 ; p < 0.0001 ) at Week 52 .


The frequency of adverse events ( linagliptin 81.3 % , placebo 91.9 % ) and hypoglycemia ( Week 24 : linagliptin 25.0 % , placebo 25.7 % ; treatment end : linagliptin 28.8 % , placebo 35.1 % ) was similar between groups .


By Week 52 , changes ( SE ) in mean body weight were similar in both groups ( linagliptin -0.67 [ 0.26 ] kg , placebo -0.38 [ 0.25 ] kg ) .


This study was limited by the post hoc nature of the analysis and the small number of patients in the subgroup .


However , the results suggest that linagliptin significantly improves glycemic control in Asian patients with T2DM inadequately controlled by basal insulin , without increasing the risk for hypoglycemia or weight gain .


ClinicalTrials identifier : NCT00954447 .


Dual dependence on opiate and cocaine occurs in about 60 % of patients admitted to methadone maintenance and negatively impacts prognosis ( Kosten et al. 2003 .


Drug Alcohol Depend .


70 , 315 ) .


Topiramate ( TOP ) is an antiepileptic drug that may have utility in the treatment of cocaine dependence because it enhances the GABAergic system , antagonizes the glutamatergic system , and has been identified by NIDA as one of only a few medications providing a `` positive signal '' warranting further clinical investigation .


( Vocci and Ling , 2005 .


Pharmacol .


Ther .


108 , 94 ) .


In this double-blind controlled clinical trial , cocaine dependent methadone maintenance patients ( N = 171 ) were randomly assigned to one of four groups .


Under a factorial design , participants received either TOP or placebo , and monetary voucher incentives that were either contingent ( CM ) or non-contingent ( Non-CM ) on drug abstinence .


TOP participants were inducted onto TOP over 7 weeks , stabilized for 8 weeks at 300 mg daily then tapered over 3 weeks .


Voucher incentives were supplied for 12 weeks , starting during the fourth week of TOP induction .


Primary outcome measures were cocaine abstinence ( Y/N ) as measured by thrice weekly urinalysis and analyzed using Generalized Estimating Equations ( GEE ) and treatment retention .


All analyses were intent to treat and included the 12-week evaluation phase of combined TOP/P treatment and voucher intervention period .


There was no significant difference in cocaine abstinence between the TOP vs. P conditions nor between the CM vs. Non-CM conditions .


There was no significant TOP/CM interaction .


Retention was not significantly different between the groups .


Topiramate is not efficacious for increasing cocaine abstinence in methadone patients .


The question-behaviour effect ( QBE ) refers to the finding that measuring behavioural intentions increases performance of the relevant behaviour .


This effect has been used to change health behaviours .


The present research asks why the QBE occurs and evaluates one possible mediator-attitude accessibility .


University staff and students ( N = 151 ) were randomly assigned to an intention measurement condition where they reported their intentions to eat healthy foods , or to one of two control conditions .


Participants completed a response latency measure of attitude accessibility , before healthy eating behaviour was assessed unobtrusively using an objective measure of snacking .


Intention measurement participants exhibited more accessible attitudes towards healthy foods , and were more likely to choose a healthy snack , relative to control participants .


Furthermore , attitude accessibility mediated the relationship between intention measurement and behaviour .


This research demonstrates that increased attitude accessibility may explain the QBE , extending the findings of previous research to the domain of health behaviour .


Laparoscopy-assisted distal gastrectomy ( LADG ) for gastric cancer may prevent the development of an impaired nutritional status due to reduced surgical stress compared with open distal gastrectomy ( ODG ) .


This study was performed as an exploratory analysis of a phase III trial comparing LADG and ODG for stage I gastric cancer during the period between May and December of 2011 .


All patients received the same perioperative care via fast-track surgery .


The level of surgical stress was evaluated based on the white blood cell count and the interleukin-6 ( IL-6 ) level .


The nutritional status was measured according to the total body weight , amount of lean body mass , lymphocyte count , and prealbumin level .


Twenty-six patients were randomized to receive ODG ( 13 patients ) or LADG ( 13 patients ) .


The baseline characteristics and surgical outcomes were similar between the two groups .


The median IL-6 level increased from 0.8 to 36.3 pg/dl in the ODG group and from 1.5 to 53.3 pg/dl in the LADG group .


The median amount of lean body mass decreased from 48.3 to 46.8 kg in the ODG group and from 46.6 to 46.0 kg in the LADG group .


There are no significant differences between two groups .


The level of surgical stress and the nutritional status were found to be similar between the ODG and LADG groups in a randomized comparison using the same perioperative care of fast-track surgery .


From a previously validated paediatric population pharmacokinetic model , it was derived that non-linear morphine maintenance doses of 5 g/kg ( 1.5 ) / h , with a 50 % dose reduction in neonates with a postnatal age ( PNA ) < 10 days , yield similar morphine and metabolite concentrations across patients younger than 3 years .


Compared with traditional dosing , this model-derived dosing regimen yields significantly reduced doses in neonates aged < 10 days .


Concentration predictions of the population model were prospectively evaluated in postoperative term neonates and infants up to the age of 1 year who received morphine doses according to the model-derived algorithm .


The efficacy of this dosing algorithm was evaluated using morphine rescue medication and actual average infusion rates .


Morphine and metabolite concentrations were accurately predicted by the paediatric pharmacokinetic morphine model .


With regard to efficacy , 5 out of 18 neonates ( 27.8 % ) with a PNA of < 10 days needed rescue medication versus 18 of the 20 older patients ( 90 % ) ( p = 0.06 ) .


The median ( interquartile range [ IQR ] ) total morphine rescue dose was 0 ( 0-20 ) g/kg in younger patients versus 193 ( 19-362 ) g/kg in older patients ( p = 0.003 ) .


The median ( IQR ) actual average morphine infusion rate was 4.4 ( 4.0-4 .8 ) g/kg/h in younger patients versus 14.4 ( 11.3-23 .4 ) g/kg/h in older patients ( p < 0.001 ) .


Morphine paediatric dosing algorithms corrected for pharmacokinetic differences alone yield effective doses that prevent over-dosing for neonates with a PNA < 10 days .


The fact that many neonates and infants with a PNA 10 days still required rescue medication warrants pharmacodynamic studies to further optimize the dosing algorithm for these patients .


Palonosetron is a potent second generation 5 - hydroxytryptamine-3 selective antagonist which can be administered by either intravenous ( IV ) or oral routes , but subcutaneous ( SC ) administration of palonosetron has never been studied , even though it could have useful clinical applications .


In this study , we evaluate the bioavailability of SC palonosetron .


Patients treated with platinum-based chemotherapy were randomized to receive SC or IV palonosetron , followed by the alternative route in a crossover manner , during the first two cycles of chemotherapy .


Blood samples were collected at baseline and 10 , 15 , 30 , 45 , 60 , 90 minutes and 2 , 3 , 4 , 6 , 8 , 12 and 24 h after palonosetron administration .


Urine was collected during 12 hours following palonosetron .


We compared pharmacokinetic parameters including AUC0-24h , t1/2 , and Cmax observed with each route of administration by analysis of variance ( ANOVA ) .


From October 2009 to July 2010 , 25 evaluable patients were included .


AUC0-24h for IV and SC palonosetron were respectively 14.1 and 12.7 ng h/ml ( p = 0.160 ) .


Bioavalability of SC palonosetron was 118 % ( 95 % IC : 69-168 ) .


Cmax was lower with SC than with IV route and was reached 15 minutes following SC administration .


Palonosetron bioavailability was similar when administered by either SC or IV route .


This new route of administration might be specially useful for outpatient management of emesis and for administration of oral chemotherapy .


ClinicalTrials.gov NCT01046240 .


Inorganic nitrate ( NO3 ( - ) ) , abundant in certain vegetables , is converted to nitrite by bacteria in the oral cavity .


Nitrite can be converted to nitric oxide in the setting of hypoxia .


We tested the hypothesis that NO3 ( - ) supplementation improves exercise capacity in heart failure with preserved ejection fraction via specific adaptations to exercise .


Seventeen subjects participated in this randomized , double-blind , crossover study comparing a single dose of NO3-rich beetroot juice ( NO3 ( - ) , 12.9 mmol ) with an identical nitrate-depleted placebo .


Subjects performed supine-cycle maximal-effort cardiopulmonary exercise tests , with measurements of cardiac output and skeletal muscle oxygenation .


We also assessed skeletal muscle oxidative function .


Study end points included exercise efficiency ( total work/total oxygen consumed ) , peak VO2 , total work performed , vasodilatory reserve , forearm mitochondrial oxidative function , and augmentation index ( a marker of arterial wave reflections , measured via radial arterial tonometry ) .


Supplementation increased plasma nitric oxide metabolites ( median , 326 versus 10 mol/L ; P = 0.0003 ) , peak VO2 ( 12.63.7 versus 11.63.1 mL O2min ( -1 ) kg ( -1 ) ; P = 0.005 ) , and total work performed ( 55.635.3 versus 49.228.9 kJ ; P = 0.04 ) .


However , efficiency was unchanged .


NO3 ( - ) led to greater reductions in systemic vascular resistance ( -42.416.6 % versus -31.820.3 % ; P = 0.03 ) and increases in cardiac output ( 121.259.9 % versus 88.753.3 % ; P = 0.006 ) with exercise .


NO3 ( - ) reduced aortic augmentation index ( 132.216.7 % versus 141.421.9 % ; P = 0.03 ) and tended to improve mitochondrial oxidative function .


NO3 ( - ) increased exercise capacity in heart failure with preserved ejection fraction by targeting peripheral abnormalities .


Efficiency did not change as a result of parallel increases in total work and VO2 .


NO3 ( - ) increased exercise vasodilatory and cardiac output reserves .


NO3 ( - ) also reduced arterial wave reflections , which are linked to left ventricular diastolic dysfunction and remodeling .


www.clinicaltrials.gov .


Unique identifier : NCT01919177 .


The combination of pulsed dye laser ( PDL ) and topical propranolol are used with variable effectiveness for the treatment of infantile hemangiomas ( IH ) , particularly for superficial lesions .


The aim of this study was to investigate whether the therapeutic efficacy of prescribing topical propranolol along with PDL was superior to PDL therapy alone in the treatment of IH .


A total of 19 patients with IH were recruited to the study .


Among them , nine patients were treated with PDL , 3 sessions 4 weeks apart , and 10 patients underwent PDL treatment alongside with topical propranolol for 12 weeks .


The therapeutic efficacies of each regimen were assessed by comparing photographs of skin lesions before and after the treatment based on the cessation of the lesion growth , reduction in the lesion size , and lightening of the lesion color .


No side-effect was reported by the parents .


Among nine patients in PDL group , only two ( 22 % ) had excellent clearance , one ( 11 % ) had good , three ( 30 % ) had weak , and three ( 30 % ) had no responses .


On the other hand , among 10 patients who were treated with both the PDL and topical propranolol , five ( 50 % ) showed excellent responses and five ( 50 % ) displayed good responses .


Statistical data analysis with Mann-Whitney test revealed a significant difference in the clinical response between two treatment groups .


The combination of PDL and topical propranolol seem to be a safe and effective therapy , and results in better clinical responses in the treatment of IH than PDL therapy alone .


Surfactant has been shown to be dysfunctional in ARDS , and exogenous surfactant has proven effective in many forms of neonatal and pediatric acute lung injury ( ALI ) .


In view of the positive results of our studies in children along with evidence that surfactant-associated protein B containing pharmaceutical surfactants might be more effective , we designed a multiinstitutional , randomized , controlled , and masked trial of calfactant , a calf lung surfactant , in adults and children with ALI/ARDS due to direct lung injury .


Adult subjects within 48 h of initiation of mechanical ventilation for direct ARDS were randomized to receive up to three interventions with instilled calfactant vs air placebo .


The primary outcome was 90-day all-cause mortality .


Three hundred seventeen subjects were enrolled , 308 of whom could be evaluated .


There were no significant baseline differences between groups .


Calfactant administration was not associated with improved survival , lengths of stay , or oxygenation .


Calfactant instillation was frequently associated with transient hypoxia and hypotension .


The study was stopped at the first interim analysis at the sponsor 's request .


Administration of calfactant was not associated with improved oxygenation or longer-term benefits relative to placebo in this randomized , controlled , and masked trial .


At present , exogenous surfactant can not be recommended for routine clinical use in ARDS .


ClinicalTrials.gov ; No. : NCT00682500 ; URL : www.clinicaltrials.gov .


Herpes simplex keratitis ( HSK ) caused by herpes simplex virus 1 ( HSV-1 ) , which has high recurrent rate and incidence of severe vision loss , is the leading cause of infectious blindness in the world .


The aim was to explore the clinical efficacy of oral ganciclovir ( GCV ) in the prevention of recurrent HSK .


A multicenter , prospective , randomized , single-blind , and controlled clinical trial was conducted from April 2010 to June 2013 .


One hundred seventy-three patients ( 173 eyes involved ) who were diagnosed as recurrent HSK definitely , including stromal keratitis and corneal endotheliitis , were divided into three groups randomly : negative control ( placebo ) group was topically administered with 0.15 % GCV ophthalmic gel , 4 times per day and 0.1 % fluorometholone eye drops , 3 times per day until resolution of HSK ; positive control acyclovir ( ACV ) group was topically adopted the same ophthalmic gel and eye drops and additionally received oral ACV 400 mg 5 times a day for 10 weeks and followed by 400 mg 2 times per day for 6 months ; test GCV group was topically adopted the same treatment as negative control group and additionally received oral GCV 1000 mg 3 times per day for 8 weeks .


The symptoms and signs were evaluated before and after the therapy 1 st week , 2 nd week and then followed up every 2 weeks until recovery .


Furthermore , we followed up recurrence of HSK for every 3 months after recovery and then assessed the cure time , recurrent rate and adverse reactions .


One hundred and seventy-three patients were followed up 7-48 months ( mean 32.1 12.3 months ) , but 34 patients were failed to follow-up .


The cure time was 12.1 4.3 , 11.9 4.0 weeks in negative control ( placebo ) group and positive control ACV group respectively ( P = 0.991 ) , which was longer than that in test GCV group ( 8.6 2.8 weeks ) and there was a significant difference between test GCV group and negative control ( placebo ) group or positive control ACV group ( P = 0.000 ) .


Furthermore , the recurrent rate was higher in negative control ( placebo ) group ( 47.3 % ) than that in positive control group ACV ( 26.7 % ) and test GCV group ( 17.2 % ) , and there was a great significant difference among the three groups ( P = 0.007 ) , but there was no significant difference between positive control ACV group and test GCV group ( P = 0.358 ) .


In addition , there was no obvious adverse reaction expect neutropenia ( only one patient in test GCV group ) .


Short-term oral GCV could cure recurrent HSK and endotheliitis , shorten the course , reduce recurrent rate of HSK and have confirmed safety .


We planned a randomized , open-label trial to evaluate differences between pre-emptive and reactive skin treatment for panitumumab ( Pmab ) - associated skin toxicities in Japanese patients with metastatic colorectal cancer .


Patients receiving third-line Pmab-containing regimens were randomized to pre-emptive or reactive treatment .


The primary end point was the cumulative incidence of grade 2 skin toxicities during 6 weeks .


Retrospectively , a dermatologist reviewed skin toxicities , in a blinded manner .


A total of 95 patients were enrolled ( pre-emptive : 47 , reactive : 48 ) .


The primary end point was achieved ( 21.3 and 62.5 % [ risk ratio : 0.34 ; p < 0.001 ] , for pre-emptive and reactive treatment , respectively ) .


A similar trend was observed in central review .


Pre-emptive skin treatment could reduce the severity of Pmab-associated skin toxicities in Japanese metastatic colorectal cancer patients .


VEGF and VEGF receptor-2-mediated angiogenesis contribute to hepatocellular carcinoma pathogenesis .


Ramucirumab is a recombinant IgG1 monoclonal antibody and VEGF receptor-2 antagonist .


We aimed to assess the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma following first-line therapy with sorafenib .


In this randomised , placebo-controlled , double-blind , multicentre , phase 3 trial ( REACH ) , patients were enrolled from 154 centres in 27 countries .


Eligible patients were aged 18 years or older , had hepatocellular carcinoma with Barcelona Clinic Liver Cancer stage C disease or stage B disease that was refractory or not amenable to locoregional therapy , had Child-Pugh A liver disease , an Eastern Cooperative Oncology Group performance status of 0 or 1 , had previously received sorafenib ( stopped because of progression or intolerance ) , and had adequate haematological and biochemical parameters .


Patients were randomly assigned ( 1:1 ) to receive intravenous ramucirumab ( 8 mg/kg ) or placebo every 2 weeks , plus best supportive care , until disease progression , unacceptable toxicity , or death .


Randomisation was stratified by geographic region and cause of liver disease with a stratified permuted block method .


Patients , medical staff , investigators , and the funder were masked to treatment assignment .


The primary endpoint was overall survival in the intention-to-treat population .


This study is registered with ClinicalTrials.gov , number NCT01140347 .


Between Nov 4 , 2010 , and April 18 , 2013 , 565 patients were enrolled , of whom 283 were assigned to ramucirumab and 282 were assigned to placebo .


Median overall survival for the ramucirumab group was 92 months ( 95 % CI 80-106 ) versus 76 months ( 60-93 ) for the placebo group ( HR 087 [ 95 % CI 072-105 ] ; p = 014 ) .


Grade 3 or greater adverse events occurring in 5 % or more of patients in either treatment group were ascites ( 13 [ 5 % ] of 277 patients treated with ramucirumab vs 11 [ 4 % ] of 276 patients treated with placebo ) , hypertension ( 34 [ 12 % ] vs ten [ 4 % ] ) , asthenia ( 14 [ 5 % ] vs five [ 2 % ] ) , malignant neoplasm progression ( 18 [ 6 % ] vs 11 [ 4 % ] ) , increased aspartate aminotransferase concentration ( 15 [ 5 % ] vs 23 [ 8 % ] ) , thrombocytopenia ( 13 [ 5 % ] vs one [ < 1 % ] ) , hyperbilirubinaemia ( three [ 1 % ] vs 13 [ 5 % ] ) , and increased blood bilirubin ( five [ 2 % ] vs 14 [ 5 % ] ) .


The most frequently reported ( 1 % ) treatment-emergent serious adverse event of any grade or grade 3 or more was malignant neoplasm progression .


Second-line treatment with ramucirumab did not significantly improve survival over placebo in patients with advanced hepatocellular carcinoma .


No new safety signals were noted in eligible patients and the safety profile is manageable .


Eli Lilly and Co. .


Early ceramic bearing systems in total hip arthoplasty ( THA ) sought to provide long term wear improvement over traditional metal on polyethylene systems .


However , previous designs exhibited fractures of the ceramic acetabular liner , leading to the development of the Implex Hedrocel ceramic bearing THA system where the ceramic liner was supported on a layer of polyethylene intended to transition liner loads to the metal shell , a so-called `` sandwich '' design .


Unfortunately , the device trial was stopped to further enrollment when liner fractures were reported .


The current study examines nearly 10-year follow-up on 28 devices implanted by two surgeons at one institution in order to document ceramic bearing system performance over a longer time period .


Radiographic and patient reported outcomes , in the form of Harris Hip Scores ( HHS ) and 12-Item Short Form Health Survey ( sF-12 ) , were collected .


During the study period two cups were replaced , one at three years and a second at seven years .


At the five year follow-up HHS were similar to those reported in the literature for devices with traditional metal-on-polyethylene bearing surfaces and for other sandwich ceramic bearing designs .


At the nine year follow-up , the HHS had not changed significantly and SF-12 scores measuring overall physical and mental health were higher than age matched national norms ( p < 0.001 ) .


There were no signs of cup migration , stem subsidence , osteolysis or cup loosening at any time up to the last follow-up in this patient cohort .


The 89 % survivorship rate and device revisions due to delamination of the liner observed in this group were similar to those reported earlier for this device and for other `` sandwich design '' ceramic bearing systems .


This cohort did not exhibit new failure modes and HHS and SF-12 scores indicated high functionality for the majority of patients .


These data suggest that a focus on preventing ceramic liner fracture through design and/or materials improvements may result in a device with long-term functionality .


In this study , our aim was to evaluate the effects of intravenous dexketoprofen trometamol with ilioinguinal and iliohypogastric nerve block on analgesic quality and morphine consumption after total abdominal hysterectomy operations .


We conducted this randomized controlled clinical study on 61 patients .


The study was conducted in the operation room , post-anesthesia care unit , and inpatient clinic .


We randomly grouped the 61 patients into control group ( group C ) , block group ( group B ) and dexketoprofen-block group ( group DB ) .


Before the skin incision performed after anesthesia induction , we performed ilioinguinal iliohypogastric block ( group C given saline and group P and DB given levobupivacaine ) .


In contrast to group C and B , group DB was given dexketoprofen .


We administered morphine analgesia to all patients by patient-controlled analgesia ( PCA ) during the postoperative 24 hours .


We recorded Visual Analogue Scale ( VAS ) , satisfaction scores , morphine consumption and side effects during postoperative 24 hours .


We found the DB group 's VAS scores to be lower than the control group and block group 's ( p < 0.05 ) values at postoperative 1 ( st ) , 2 ( nd ) , 6 ( th ) and 12 ( th ) hours .


VAS scores of group C were higher than of group B at postoperative first 2 hours .


Time to first PCA demand was longer , morphine consumption values were lower and satisfaction scores were higher in group DB than in the other two groups ( p < 0.05 ) .


Ilioinguinal-iliohypogastric nerve block with IV dexketoprofen increases patient satisfaction by decreasing opioid consumption , increasing patient satisfaction , which suggests that dexketoprofen trometamol is an effective non-steroidal anti-inflammatory analgesic in postoperative analgesia .


To determine whether strict blood pressure ( BP ) control is the best medical management for patients with symptomatic carotid artery occlusion and hemodynamic cerebral ischemia .


In this prospective observational cohort study , we analyzed data from 91 participants in the nonsurgical group of the Carotid Occlusion Surgery Study ( COSS ) who had recent symptomatic internal carotid artery occlusion and hemodynamic cerebral ischemia manifested by ipsilateral increased oxygen extraction fraction .


The target BP goal in COSS was 130/85 mm Hg .


We compared the occurrence of ipsilateral ischemic stroke during follow-up in the 41 participants with mean BP 130/85 mm Hg to the remaining 50 with higher BP .


Of 16 total ipsilateral ischemic strokes that occurred during follow-up , 3 occurred in the 41 participants with mean follow-up BP of 130/85 mm Hg , compared to 13 in the remaining 50 participants with mean follow-up BP > 130/85 mm Hg ( hazard ratio 3.742 , 95 % confidence interval 1.065-13 .152 , log-rank p = 0.027 ) .


BPs 130/85 mm Hg were associated with lower subsequent stroke risk in these patients .


This study provides Class III evidence that control of hypertension 130/85 mm Hg is associated with a reduced risk of subsequent ipsilateral ischemic stroke in patients with recently symptomatic carotid occlusion and hemodynamic cerebral ischemia ( increased oxygen extraction fraction ) .


Arthroscopic capsular release is an effective treatment for shoulder stiffness , yet its extent is controversial .


To compare the clinical outcomes of arthroscopic capsular release in patients with and without posterior extended capsular release for shoulder stiffness .


Randomized controlled trial ; Level of evidence , 1 .


Between January 2008 and March 2011 , 75 patients who underwent arthroscopic capsular release for shoulder stiffness were enrolled and randomized into 2 groups .


In group I ( n = 37 ) , capsular release was performed , including release of the rotator interval and anterior and inferior capsule .


In group II ( n = 38 ) , capsular release was extended to the posterior capsule .


The American Shoulder and Elbow Surgeons score , Simple Shoulder Test , visual analog scale for pain , and range of motion ( ROM ) were used for the evaluation before surgery and at 3 , 6 , and 12 months after surgery and at the last follow-up .


Preoperative demographic data of age , sex , symptom duration , and clinical outcomes showed no significant differences ( P > .05 ) .


The average follow-up was 18.4 months .


Both groups showed significantly increased ROM at the last follow-up compared with preoperative ROM ( P < .05 ) .


At the last follow-up , no statistical differences were found ( P > .05 ) between groups I and II in American Shoulder and Elbow Surgeons score ( 91.3 vs. 79.5 ) , Simple Shoulder Test ( 83.3 vs. 83.3 ) , and visual analog scale ( 1.5 vs. 2.2 ) .


There were also no statistical differences between the 2 groups at the last follow-up ( P > .05 ) in ROM : forward flexion , 145.2 vs. 143.3 ; external rotation with 90 of abduction , 88.1 vs. 86.2 ; external rotation at side , 88.9 vs. 82.9 ; and internal rotation , 9.1 vs. 8.3 .


Posterior extended capsular release might not be necessary in arthroscopic surgery for shoulder stiffness .


The aim of this study is to compare quality of life in 3-month follow-up after the use of transobturator tape TVT-O and single incision tape AJUST in the treatment of urodynamic stress urinary incontinence ( USI ) .


Randomized trial .


Gynekologicko-porodnick klinika LF UK a FN Plze , Gynekologicko-porodnick klinika 1 .


LF UK a VFN Praha .


Between May 2010 and May 2012 100 women with proven urodynamic stress urinary incontinence were included in this randomized trial .


These patients were randomly chosen and devided into two group : 50 patients for TVT-O procedure and 50 patients for AJUST procedure .


All of the patients underwent a complete urogynecological examination prior to the actual procedure ( clinical examination , urodynamic examination , ultrasound examination ) and filled in ICIQ-SF and iQol questionnaires .


After the surgery , the patients satisfaction was evaluated by visual analoque scale ( VAS ) and Likert scale and by ICIQ-SF and iQol questionnaires .


The intensity and length of postoperative pain was monitored using the visual analogue scale .


The patients underwent an examination after 3 months .


In both groups of participants no significant differences regarding age , BMI , parity , history of surgery for gynecological disorders , were found .


Preoperative urodynamic , ICIQ-SF and iQol parameters were also not significantly different .


In the 3-month follow-up 48 participants from TVT-O group and 50 participants from the AJUST group were monitored .


No statistically significant differences in subjective and objective parameters were found .


Subjectively stress incontinence was not present in 97.9 % in the TVT-O and 96.0 % in the group AJUST .


Objectively stress test was negative in 93.8 % in the TVT-O and 94 % in group AJUST .


By evaluating the ICIQ and iQol were found no statistical differences in the quality of life in both operating groups .


At 3-months follow up we did not find any statistical difference between subjective and objective outcome for single incision tape AJUST and TVT-O .


In the AJUST group lower intensity and shorter duration of postoperative pain were observed .


Patients who develop relapsing-remitting multiple sclerosis ( MS ) present with a first clinical demyelinating event .


In this double-blind , multicentre , randomised , phase 3 study we investigated the effect of oral cladribine on conversion to clinically definite MS in patients with a first clinical demyelinating event , when given at the same doses shown to be effective in relapsing-remitting MS.


Between Oct 21 , 2008 , and Oct 11 , 2010 , we recruited patients aged 18-55 years , inclusive , from 160 hospitals , private clinics , or treatment centres in 34 countries .


Eligible patients had a first clinical demyelinating event within 75 days before screening , at least two clinically silent lesions of at least 3 mm on a T2-weighted brain MRI scan , and an Expanded Disability Status Scale score of 5.0 or lower .


Patients with a first clinical demyelinating event 75 days before screening were randomly assigned ( 1:1:1 ) to receive cladribine tablets at cumulative doses of 5.25 mg/kg or 3.5 mg/kg or placebo .


Randomisation was done with a central web-based randomisation system and was stratified by geographic region .


Masking was maintained using a two-physician model .


The primary endpoint of this 96-week study was time to conversion to clinically definite MS according to the Poser criteria .


This study is registered with ClinicalTrials.gov , number NCT00725985 .


Of 903 participants assessed for eligibility , 616 patients received cladribine 5.25 mg/kg ( n = 204 ) , cladribine 3.5 mg/kg ( n = 206 ) , or placebo ( n = 206 ) .


At trial termination on Oct 25 , 2011 , cladribine was associated with a risk reduction versus placebo for time to conversion to clinically definite MS ( hazard ratio [ HR ] for 5.25 mg/kg = 0.38 , 95 % CI 0.25-0 .58 , p < 0.0001 ; HR for 3.5 mg/kg = 0.33 , 0.21-0 .51 , p < 0.0001 ) .


Adverse events were reported in 165 ( 81 % ) patients in the cladribine 5.25 mg/kg group , 168 ( 82 % ) patients in the cladribine 3.5 mg/kg group , and 162 ( 79 % ) patients in the placebo group .


We noted no increase in risk of adverse events with active treatment versus placebo apart from lymphopenia , which was a severe event in 10 ( 5 % ) patients in the 5.25 mg/kg group and four ( 2 % ) patients in the 3.5 mg/kg group .


Both doses of cladribine significantly delayed MS diagnosis compared with placebo .


The safety profile of cladribine was similar to that noted in a trial in patients with relapsing-remitting MS. Further research could clarify the potential effects of oral cladribine treatment in the early stages of MS.


Merck Serono SA Geneva , a subsidiary of Merck KGaA , Darmstadt , Germany .


The aim of this work was to study the reduction in intraocular pressure ( IOP ) after two selective laser trabeculoplasty ( SLT ) treatments in the same area of the trabecular meshwork ( TM ) compared to two SLT treatments in two different areas of the TM when the initial SLT treatment has failed .


This was a prospective randomized clinical trial for testing the effect of repeated SLT treatments in reducing IOP .


The patients in the study all suffered from primary open-angle or pseudoexfoliation glaucoma .


All patients were treated initially with SLT ( SLT 1 ) over 180 in the lower half of the TM .


Patients who were chosen for retreatment with SLT ( SLT 2 ) were asked to participate in the study .


The patients in the study were randomized to either SLT 2 in the same , already-treated TM area or to SLT 2 in the upper untreated TM area .


The IOP was measured before and 2h , 1month , 3months , and 6months after the SLT 2 treatment .


Patients who changed medical therapy regimens during this time were excluded .


A total of 40 patients were included in both groups .


At baseline , there were no significant differences between the groups in regards to age ( t-test , p = 0.44 ) , gender ( ( 2 ) , p = 0.14 ) , pseudoexfoliation glaucoma ( ( 2 ) , p = 0.07 ) , time between SLT 1 and SLT 2 ( t-test , p = 0.78 ) , IOP before SLT 1 ( t-test , p = 0.78 ) , or IOP before SLT 2 ( t-test , p = 0.32 ) .


At the conclusion of the study , there were no significant differences in IOP between the groups 2h ( t-test , p = 0.65 ) , 1month ( t-test , p = 0.60 ) , 3months ( t-test , p = 0.42 ) , or 6months ( t-test , p = 0.66 ) after the SLT 2 treatment .


Two SLT treatments of the same TM area do not have a significant effect on IOP compared to two SLT treatments in two different areas .


Using the database of the National Institute of Mental Health-sponsored acute treatment of late life mania study ( GERI-BD ) , we assessed the role of social support in the presentation of late life bipolar mania .


In the first 100 subjects randomized in geriatric BD , we explored the demographic , clinical , and social support characteristics ( assessed using the Duke Social Support Index ) and aspects of manic presentation .


We selected two dependent variables : symptom severity , as determined by the Young Mania Rating Scale ( YMRS ) at baseline , and duration of episode .


We selected nine potential independent variables on the basis of Pearson correlation coefficients .


We derived two final models using multiple regression analysis employing an iterative process .


In our severity model , being married was associated with a higher YMRS score ( p = 0.05 ) , whereas higher social interaction scores with non-family members were associated with a lower YMRS score ( p = 0.011 ) .


In the episode duration model , longer duration was associated with a higher Hamilton Depression Rating Scale score ( p = 0.03 ) and higher social interaction scores with non-family members ( p = 0.0003 ) , younger age ( p = 0.04 ) , higher number of persons in one 's family social network ( p = 0.017 ) , and higher instrumental support scores ( p = 0.0062 ) .


In late life mania , more social interaction with one 's community appears to be associated with less severe symptoms at presentation for treatment , however , it can also be associated with slightly longer the duration of episode .


Two aspects of the Duke Social Support Index are associated with a shorter episode duration prior to seeking treatment : being part of a larger family network and a having a higher level of instrumental support prior to treatment .


The Instrumental Support Subscale measures the degree of assistance that is available for the respondent in performing daily tasks .


These findings suggest that in older adults with BD , close social interactions and support are important in limiting the length of the illness episode prior to treatment .


Social interactions involving non-family members may be less important in moderating the intensity of the symptoms at presentation .


To determine the efficacy of brief Culturally adapted CBT ( CaCBT ) for depression when added to Treatment As usual ( TAU ) - delivered by trained therapists using a manual compared with alone TAU .


This was an assessor-blinded , randomised controlled clinical trial .


Particpants with a diagnosis of depression , attending psychiatry departments of three teaching hospitals in Lahore , Pakistan , were included in the study .


We screened a total of 280 patients and randomly allocated 137 of them to CaCBT plus Treatment As Usual ( TAU ) [ Treatment group ] or to TAU alone [ Control group ] .


Assessments were completed at baseline , at 3 months and at 9 months after baseline .


Reduction in depression score ( Hospital Anxiety and Depression-Depression Subscale ) at 3 months was primary outcome measure .


The secondary outcome measures included anxiety scores ( Hospital Anxiety and Depression-Anxiety Subscale ) , somatic symptoms ( Bradford Somatic Inventory ) , disability ( Brief Disability Questionnaire ) and satisfaction with the treatment .


A total of 69 participants were randomised to Treatment group and 68 to Control group .


Participants in Treatment group showed statistically significant improvement in depression ( p = 0.000 ) , anxiety ( p = 0.000 ) , somatic symptoms ( p = 0.005 ) and disability ( p = 0.000 ) .


This effect was sustained at 9 months after baseline ( Except for disability ) .