Rhadbomyolysis or other serious adverse events were not reported .


In fact , 169 ( 82.4 % ) of 205 patients remained on statin treatment and 78.7 % ( 148 out of 188 ) were adherent .


None of the patient characteristics were significantly associated with adherence .


Individuals with FH who started statin therapy in childhood demonstrated good adherence during ten years of treatment .


Furthermore , statin therapy was well tolerated ; only a small minority discontinued therapy because of side effects and the side effects that were reported were mild in nature .


Delayed graft function ( DGF ) is a consequence of ischemia-reperfusion injuries in kidney allografts , for which no definite treatment is available .


The neutrophil gelatinase-associated lipocalin ( NGAL ) and interleukin-18 ( IL-18 ) are introduced as the most promising urine biomarkers to detect DGF .


N-acetylcysteine ( NAC ) and vitamin C , well-known potent antioxidants that scavenge free radicals , may alleviate kidney injury .


This study investigated the protective effects of NAC alone and in combination with vitamin C on DGF , by measuring IL-18 and NGAL in living donor kidney transplantations .


Patients transplanted between January 2011 and February 2013 were randomly divided into 3 groups to receive routine anti-rejection medication only ( n = 32 ) , NAC plus routine immunosuppressive regimen ( NAC group ; n = 33 ) , and NAC and vitamin C plus routine regimen ( NAC and vitamin C group ; n = 19 ) .


Urine samples were taken 4 hours and 24 hours after transplantation .


Enzyme-linked immunosorbent assay kits were utilized for measuring urine NGAL and IL-18 .


There were no significant differences in the DGF prevalence and its duration between the study arms .


Although the levels of NGAL and IL-18 decreased in the NAC and NAC and vitamin C groups , these reductions were not significant .


Glomerular filtration rate at 30 and 60 days after transplantation were not significantly different between study groups , either .


Our results showed that NAC is a safe drug without significant adverse effects in kidney transplant recipients ; however , its potential useful effects on urinary biomarkers of DGF were not illustrated in the present study .


The purpose of this study was to determine whether obtaining a radiograph of the uninjured contralateral calcaneus ( template ) before surgery allowed for more precise restoration of Bohler 's angle and calcaneal length when performing open reduction internal fixation ( ORIF ) of intra-articular calcaneus fractures .


Patients who sustained an intra-articular calcaneus fracture requiring surgery who met inclusion criteria were prospectively randomized into those who had a preoperative template obtained for review at the time of ORIF ( group 1 ) versus those who had the contralateral radiograph obtained after surgery ( group 2 ) .


There was no benefit of the preoperative template in allowing for more anatomic restoration of Bohler 's angle or calcaneal length .


Operative time was decreased with the use of a preoperative template when using the extensile lateral or percutaneous approaches .


Preoperative templating of the uninjured contralateral calcaneus did not allow for more anatomic reduction or restoration of pre-injury morphology of the calcaneus undergoing operative fixation as based on Bohler 's angle and calcaneal length .


Templating may be of benefit by reducing operative time .


Level II , prospective comparative series .


To determine the effectiveness of a water flosser in reducing the bleeding on probing ( BOP ) index around dental implants as compared to flossing .


Patients with implants were randomly assigned to one of two groups in this examiner-masked , single-center study .


The study compared the efficacy of a manual toothbrush paired with either traditional string floss or a water flosser .


The primary outcome was the reduction in the incidence of BOP after 30 days .


There were no differences in the percent of bleeding sites between the groups at baseline .


At 30 days , 18 of the 22 ( 81.8 % ) implants in the water flosser group showed a reduction in BOP compared to 6 of the 18 ( 33.3 % ) in the floss group ( P = 0.0018 ) .


These results demonstrate that the water flosser group had statistically significantly greater bleeding reduction than the string floss group .


The authors concluded that water flossing may be a useful adjuvant for implant hygiene maintenance .


In Saudi Arabia many studies have addressed cigarette smoking from various perspectives .


Most of these studies , however , were conducted among males and confined to Riyadh , the capital city .


Such limitations have enhanced the need for community-based epidemiological studies that include both genders and various age groups and socio-demographic features , as well as different regions .


This cross-sectional study aims to assess the prevalence of cigarette smoking and to discuss the association between cigarette smoking habits and socio-demographic factors among community members of the Jazan area in southwest Saudi Arabia .


A pre-coded questionnaire was designed and tested for data consistency .


A well-trained health team was assigned to gather the data from the 30 primary healthcare centers distributed across eight provinces .


The response rate was 92.8 % ( 4,326 respondents 13 years old ) .


The associations among the subjects ' socio-demographic characteristics were examined by the chi-square test .


A multiple logistic regression and odds ratios were calculated as well .


A total of 1,017 ( 23.5 % ) , 1,042 ( 24.1 % ) , and 3,284 ( 75.9 % ) respondents were , respectively , current smokers ( TCS ) , ever-smokers ( TES ) , and non-smokers ( TNS ) .


Though current smokers seem to be more prevalent in urban populations ( 13.8 % ) than in rural populations ( 9.7 % ) , the association of urbanization with a current smoking habit is insignificant .


Having fun , relieving stress , and the influence of parents , particularly of mothers , were the main motives that encouraged participants ' cigarette-smoking habits .


This situation was worsened by the fact that accessing cigarettes was either very easy or easy for over 90 % of the respondents .


To evaluate the efficacy and safety of holmium laser enucleation of the prostate ( HoLEP ) and transurethral resection of the prostate ( TURP ) , for treatment of benign prostatic hyperplasia ( BPH ) .


A total of 164 cases of BPH were selected from patients who were hospitalized between January 2010 and December 2011 .


Patients had received either HoLEP or TURP treatment .


Clinical data were collected from the perioperative period , 1 month after surgery , and 12 months after surgery .


There was no significant difference between the two groups in the maximum urinary flow rate ( Q max ) , postvoid residual volume ( PVR ) , international prostate symptom score ( IPSS ) , or quality-of-life score ( QOL score ) at 1 month after surgery ( p = 0.56 , p = 0.346 , p = 0.536 and p = 0.145 , respectively ) .


However , after 12 months , patients from the HoLEP group demonstrated better scores in Qmax , PVR , IPSS , and QOL than those from the TURP group ( p = 0.037 , p = 0.003 , p < 0.001 and p = 0.019 , respectively ) .


The two groups had comparable operation time ( p = 0.105 ) , catheterization time ( p = 0.173 ) , and length of hospital stay ( p = 0.395 ) , but were statistically different in the weight of resected prostate tissue ( p < 0.001 ) , bladder irrigation time ( p < 0.001 ) , hemoglobin levels ( p = 0.011 ) , and blood sodium levels ( p = 0.002 ) after surgery .


Compared to TURP , HoLEP was safer and had better long-term efficacy as assessed by multiple quantitative measures .


Therefore , HoLEP may present a better option in the treatment of BPH .


Young people in South Africa are at high risk of HIV infection and yet may have more limited access to prevention and treatment services than others in the population .


Testing facilitates the sharing of prevention messages but also enables the linkage to care and treatment of those who test positive and therefore has wider public health implications .


This baseline survey conducted in 2005 for a community randomized trial in rural KwaZulu-Natal explored factors associated with a history of ever , repeat and recent testing amongst sexually debuted men and women aged 18 to 32 years .


Over 35 % of this rural population ever tested for HIV , with men less likely to ever ( unadjusted OR 0.26 , 95 % CI : 0.21-0 .32 ) and repeatedly test than women ( adjusted OR ( aOR ) 0.68 , 95 % CI : 0.48-0 .97 ) .


Men aged 24-28 years ( aOR 2.02 , 95 % CI : 1.10-3 .71 ) and 29-32 years ( aOR 2.69 , 95 % CI : 1.46-4 .94 ) were more likely to ever test than those < 20 years .


Those who reported having discussed HIV with others had significantly greater odds of reporting ever ( men 's aOR 2.83 , 95 % CI : 1.63-4 .89 ; women 's aOR 3.36 , 95 % CI : 2.50-4 .53 ) , recent ( irrespective of sex , aOR 2.87 , 95 % CI : 2.02-4 .09 ) and repeat testing ( aOR 2.02 , 95 % CI : 1.28-3 .19 ) .


These findings highlight the need for novel youth - and men-friendly testing services and emphasises the importance of discussions about HIV in the home and community to encourage testing .


The purpose of the present study was to evaluate the effects of six-week aerobic training program including running and rope skipping on cardiovascular fitness , body mass index ( BMI ) , and mental health among female students at the University of Isfahan , Iran .


In this interventional study we included 30 female students in academic year 2011-12 .


The participants were randomly assigned in experimental group ( n = 15 , meanSD for age = 26.061.18 , weight ( kg ) = 57.435.67 , height ( cm ) = 160.064.16 ) and control group ( n = 15 , meanSD for age = 26.331.30 , weight = 57.665.08 , height = 161.863.29 ) .


Pre-test and post-test measurements include VO2 max with Queen Step test ; BMI and General Health Questionnaire-28 as a measure of mental health were done .


Analysis of covariance ( ANCOVA ) was used to test the effects of aerobic training as intervention ( P < 0.05 ) .


There was statistically significance difference between experimental and control groups after adjustment for their own baseline values concerning cardiovascular fitness ( P = 0.004 ) , BMI ( P < 0.001 ) and mental health indices ( P < 0.001 ) .


A six-week aerobic practice improves cardiovascular strength , mental health and BMI considerably and could be more encouraged at universities .


To explore the necessity of periodontal-pulp combined therapy for severe periodontitis .


From May 2009 to September 2011 , 52 patients who were diagnosed of severe periodontitis were involved in this study .


They were randomly divided into 2 groups .


Patients in group A were given periodontal-pulp combined therapy , while patients in group B were given periodontal therapy .


SBI , PD , AL were recorded in baseline , 3 months , 6 months , 1 year and 2 years after treatment .


Statistical analysis was performed with SPSS13 .0 software package .


All the indexes were different between 2 groups in baseline .


Three months after treatment , all the indexes were not significantly different between two groups .


Six months after treatment , SBI was significantly different between 2 groups , but PD and AL were not significantly different between 2 groups .


One year after treatment , all the indexes were significantly different between 2 groups .


Two years after treatment , SBI was not significantly different between 2 groups , but PD and AL were significantly different between two groups .


The results of periodontal-pulp combined therapy were better than periodontal therapy .


Periodontal-pulp combined therapy is necessary for patients with severe periodontitis .


In the PLATO trial , ticagrelor was superior to clopidogrel in reducing cardiovascular events among patients with acute coronary syndrome ( ACS ) at the expense of increased nonfatal bleeding .


Because Asian patients , when compared with non-Asian patients , are believed to be more susceptible to bleeding , we evaluated the effects of ticagrelor compared with clopidogrel in Asian ( n = 1,106 ) and non-Asian ( n = 17,515 ) patients with acute coronary syndrome enrolled in the PLATO study .


Interaction between Asian/non-Asian and primary efficacy end point ( a composite of vascular death , myocardial infarction , and stroke ) and net clinical benefit ( composite of primary efficacy end point and coronary artery bypass graft [ CABG ] surgery or non-CABG-related major bleeding ) were evaluated with a Cox proportional hazards model .


Baseline demographics and comorbidities were different between Asians and non-Asians .


The overall cardiovascular event rates were higher in Asians , but bleeding rates were similar .


Despite these observed differences , the effects of ticagrelor versus clopidogrel were not significantly different between Asians and non-Asians with respect to the primary efficacy outcome ( hazard ratio for Asians vs non-Asians , 0.84 [ 95 % CI 0.61-1 .17 ] vs 0.85 [ 95 % CI 0.77-0 .93 ] , P = .974 ) , net clinical benefit ( 0.85 [ 95 % CI 0.65-1 .11 ] vs 0.93 [ 95 % CI 0.86-0 .99 ] , P = .521 ) , or individual efficacy end points .


There was no significant interaction for bleeding ( PLATO major bleeding , 1.02 [ 95 % CI 0.70-1 .49 ] vs 1.04 [ 95 % CI 0.95-1 .14 ] , P = .938 ) and other related adverse events with ticagrelor compared with clopidogrel between Asians and non-Asians .


We observed consistency of effects in Asian patients receiving ticagrelor and clopidogrel in the PLATO study .


The relatively modest number of Asian patients in this analysis supports further investigation of larger cohorts to confirm our observations .


Increased elevation of the head of the bed is linked to a higher risk for sacral pressure ulcers .


A semirecumbent position of at least 30 is recommended for the prevention of ventilator-associated pneumonia in patients treated with mechanical ventilation .


Therefore , prevention of pressure ulcers and prevention of pneumonia seem to demand contradictory , possibly incompatible , positioning .


To measure pressure at the interface between sacral skin and the supporting surface in healthy volunteers at different degrees of upright position with different types of mattresses .


An open , prospective , randomized crossover trial was conducted with 20 healthy volunteers .


Interface pressure was measured by using a pressure mapping device with the participant in a supine position at 0 , 10 , 30 , and 45 elevation and in the reverse Trendelenburg position at 10 and 30 .


Four types of mattresses were examined : 2 different foam mattresses and 2 air suspension beds , 1 of the latter with low-air-loss technology .


Peak sacral interface pressures increased significantly only at 45 of backrest elevation ( P < .001 ) .


A mattress system with low-air-loss technology significantly reduced peak interface pressures at all angles ( P < .001 ) .


The reverse Trendelenburg position led to lower peak pressures for all positions ( P = .01 ) .


Backrest elevation up to 30 might be a compromise between the seemingly incompatible demands of skin integrity and the prevention of ventilator-associated pneumonia .


The reverse Trendelenburg position and a mattress system with low-air-loss technology could be additional useful tools to help prevent skin breakdown at the sacrum .


Moderate-intensity exercise training improves skeletal muscle aerobic capacity and increased oxidative enzyme activity , as well as exercise tolerance in COPD patients .


To investigate whether the home-based exercise training program can reduce inflammatory biomarkers in patients with COPD , twelve patients using mobile phone assistance and 14 with free walk were assessed by incremental shuttle walk test ( ISWT ) , spirometry , strength of limb muscles , and serum C-reactive protein ( CRP ) and inflammatory cytokines .


Patients in the mobile phone group improved their ISWT walking distance , with decrease in serum CRP after 2 months , and sustained at 6 months .


Patients in the control group had no improvement .


Serum IL-8 in the mobile phone group was significantly reduced at 2 , 3 and 6 months after doing home exercise training compared to baseline .


IL-6 and TNF - were significantly elevated at 3 and 6 months in control group , while there were no changes in mobile phone group .


The strength of limb muscles was significantly greater compared to baseline at 3 and 6 months in the mobile phone group .


A mobile-phone-based system can provide an efficient home endurance exercise training program with improved exercise capacity , strength of limb muscles and a decrease in serum CRP and IL-8 in COPD patients .


Decreased systemic inflammation may contribute to these clinical benefits .


( Clinical trial registration No. : NCT01631019 ) .


Recent studies have indicated that serum testosterone in aging men is associated with insulin sensitivity and expression of genes involved in oxidative phosphorylation ( OxPhos ) , and that testosterone treatment increases lipid oxidation .


Herein , we investigated the effect of testosterone therapy on regulators of mitochondrial biogenesis and markers of OxPhos and lipid metabolism in the skeletal muscle of aging men with subnormal bioavailable testosterone levels .


Skeletal muscle biopsies were obtained before and after treatment with either testosterone gel ( n = 12 ) or placebo ( n = 13 ) for 6 months .


Insulin sensitivity and substrate oxidation were assessed by euglycemic-hyperinsulinemic clamp and indirect calorimetry .


Muscle mRNA levels and protein abundance and phosphorylation of enzymes involved in mitochondrial biogenesis , OxPhos , and lipid metabolism were examined by quantitative real-time PCR and western blotting .


Despite an increase in lipid oxidation ( P < 0.05 ) , testosterone therapy had no effect on insulin sensitivity or mRNA levels of genes involved in mitochondrial biogenesis ( PPARGC1A , PRKAA2 , and PRKAG3 ) , OxPhos ( NDUFS1 , ETFA , SDHA , UQCRC1 , and COX5B ) , or lipid metabolism ( ACADVL , CD36 , CPT1B , HADH , and PDK4 ) .


Consistently , protein abundance of OxPhos subunits encoded by both nuclear ( SDHA and UQCRC1 ) and mitochondrial DNA ( ND6 ) and protein abundance and phosphorylation of AMP-activated protein kinase and p38 MAPK were unaffected by testosterone therapy .


The beneficial effect of testosterone treatment on lipid oxidation is not explained by increased abundance or phosphorylation-dependent activity of enzymes known to regulate mitochondrial biogenesis or markers of OxPhos and lipid metabolism in the skeletal muscle of aging men with subnormal bioavailable testosterone levels .


To explore synergistic effect between angiotensin II receptor blockers ( ARBs ) and statins on Th17/Treg functional imbalance in hypertensive patients with carotid atherosclerosis .


This study was a 2 2 factorial randomized , prospective , double-blind , placebo-controlled trial .


One hundred and fifty nine hypertensive patients with carotid atherosclerosis were randomized to the administration of control group , telmisartan group , rosuvastatin group , and combination group ( telmisartan plus rosuvastatin ) base on hydrochlorothiazide treatment .


Carotid ultrasonography , parameters of Th17/Treg functional axis , interleukin ( IL ) -1 , IL-2 , interferon ( IFN ) - , hypersensitive C-reactive protein ( hsCRP ) , monocyte chemotactic protein ( MCP ) -1 were evaluated .


Blood pressure level markedly reduced in four groups .


There was significantly synergistic effect of combination of telmisartan with rosuvastatin on reducing carotid imtima-media thickness ( IMT ) , Th17 cells frequency , IL-17 , IL-6 , IL-23 , tumor necrosis factor ( TNF ) - , expression of retinoic acid receptor-related orphan receptor ( ROR ) t mRNA , Th17/Treg ratio , IL-1 , IL-2 , IFN - , hsCRP , and MCP-1 , and increasing Treg cells frequency , IL-10 , transforming growth factor ( TGF ) -1 , and expression of forkhead/winged helix transcription factor ( Foxp3 ) mRNA ( all P < 0.05 ) .


Change rate of IMT statistical positively related to descent rates of Th17 cells frequency , IL-17 , IL-6 , IL-23 , TNF - , expression of RORt mRNA , Th17/Treg ratio , IL-1 , IL-2 , IFN - , hsCRP , and MCP-1 , and negatively related to increased rates of Treg frequency , IL-10 , TGF-1 , and expression of Foxp3 mRNA , respectively ( all P < 0.05 ) .


There is a synergistic effect of combination of telmisartan with rosuvastatin on ameliorating Th17/Treg functional imbalance in hypertensive patients with carotid atherosclerosis .


The RELAX ( Phosphodiesterase-5 Inhibition to Improve Clinical Status and Exercise Capacity in Heart Failure with Preserved Ejection Fraction ) study was a multicenter , randomized trial of sildenafil versus placebo in heart failure with preserved ejection fraction ( HFpEF ) with rigorous entry criteria and extensive phenotypic characterization of participants .


The aim of this study was to characterize clinical features , exercise capacity , and outcomes in patients with HFpEF with or without diabetes and gain insight into contributing pathophysiological mechanisms .


The RELAX study enrolled 216 stable outpatients with heart failure , an ejection fraction 50 % , increased natriuretic peptide or intracardiac pressures , and reduced exercise capacity .


Prospectively collected data included echocardiography , cardiac magnetic resonance , a comprehensive biomarker panel , exercise testing , and clinical events over 6 months .


Compared with nondiabetic patients ( n = 123 ) , diabetic HFpEF patients ( n = 93 ) were younger , more obese , and more often male and had a higher prevalence of hypertension , renal dysfunction , pulmonary disease , and vascular disease ( p < 0.05 for all ) .


Uric acid , C-reactive protein , galectin-3 , carboxy-terminal telopeptide of collagen type I , and endothelin-1 levels were higher in diabetic patients ( p < 0.05 for all ) .


Diabetic patients had more ventricular hypertrophy , but systolic and diastolic ventricular function parameters were similar in diabetic and nondiabetic patients except for a trend toward higher filling pressures ( E/e ' ) in diabetic patients .


Diabetic patients had worse maximal ( peak oxygen uptake ) and submaximal ( 6-min walk distance ) exercise capacity ( p < 0.01 for both ) .


Diabetic patients were more likely to have been hospitalized for heart failure in the year before study entry ( 47 % vs. 28 % , p = 0.004 ) and had a higher incidence of cardiac or renal hospitalization at 6 months after enrollment ( 23.7 % vs. 4.9 % , p < 0.001 ) .


HFpEF patients with diabetes are at increased risk of hospitalization and have reduced exercise capacity .


Multimorbidity , impaired chronotropic reserve , left ventricular hypertrophy , and activation of inflammatory , pro-oxidative , vasoconstrictor , and profibrotic pathways may contribute to adverse outcomes in HFpEF patients with diabetes .


( Evaluating the Effectiveness of Sildenafil at Improving Health Outcomes and Exercise Ability in People With Diastolic Heart Failure [ The RELAX Study ] ; NCT00763867 ) .


To evaluate the contribution of auriculotherapy in smoking cessation .


Double-blind randomized controlled trial , conducted with 30 smokers allocated into two groups : Experimental Group ( 21 participants received 10 sessions of auriculotherapy at specific points for smoking ) and Control Group ( nine participants received auriculotherapy in points that have no effect on the focus of research ) .


Auriculotherapy contributed in reducing the number of cigarettes smoked in 61.9 % of participants ( p = 0.002 ) , in reducing the difficult to abstain from smoking in places where it is forbidden by 38 % ( p = 0.050 ) and in not smoking when ill 23.8 % ( p = 0.025 ) .


Given the efficacy only in terms of reducing the number of cigarettes smoked and other parameters , we suggest that future studies consider the use of auriculotherapy combined with other treatment methods , in order to achieve better results in cessation/abstinence .


The Bleeding Academic Research Consortium ( BARC ) classification has been proposed by consensus to standardize bleeding endpoint definition and reporting in cardiovascular clinical trials .


There are no prospective studies on its prognostic impact .


We explored the association of BARC-defined bleeding with mortality and compared its prognostic value against two validated bleeding scales : the Thrombolysis in Myocardial Infarction ( TIMI ) and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries ( GUSTO ) scales .


Non-coronary artery bypass graft ( CABG ) - related bleedings within the PRODIGY trial were prospectively adjudicated by a blinded Clinical Event Committee and analysed according to multiple statistical modelling .


At 2 years , bleeding occurred in 143 patients ( 7.1 % ) according to BARC Type 2 , 3 , or 5 ; in 50 patients ( 2.5 % ) according to TIMI minor or major ; and in 61 patients ( 3.1 % ) according to GUSTO moderate or severe .


One hundred sixty-three patients died ( 8.1 % ) .


After multivariable modelling , BARC Type 2 , 3 , or 5 bleeding was associated with increased 2-year mortality [ hazard ratio ( HR ) : 3.77 ; 95 % confidence interval ( CI ) : 2.37-5 .98 ] .


Bleeding Academic Research Consortium Type 3 or 5 was associated with an increased mortality rate at 2 years ( adjusted HR : 7.72 ; 95 % CI : 4.75-12 .54 ) similar to that provided by TIMI ( HR : 7.64 , 95 % CI : 4.53-12 .87 ) or GUSTO ( HR : 7.36 , 95 % CI : 4.38-12 .34 ) criteria .


In a contemporary , all-comer percutaneous coronary intervention trial actionable BARC bleedings were associated with increased risk of mortality with BARC Type 3 or 5 bleedings providing a similar mortality risk to that posed by TIMI or GUSTO scales .


Given the complexity of the health insurance market in the United States and the confusion that often stems from these complexities , patient perception about the value of health insurance in managing chronic disease is important to understand .


To examine differences between public and private health insurance in perceptions of financial burden with managing asthma , outcomes , and factors that explain these perceptions .


Secondary analysis was performed using baseline data from a randomized clinical trial that were collected through telephone interviews with 219 African American women seeking services for asthma and reporting perceptions of financial burden with asthma management .


Path analysis with multigroup models and multiple variable regression analyses were used to examine associations .


For public ( P < .001 ) and private ( P < .01 ) coverage , being married and more educated were indirectly associated with greater perceptions of financial burden through different explanatory pathways .


When adjusted for multiple morbidities , asthma control , income , and out-of-pocket expenses , those with private insurance used fewer inpatient ( P < .05 ) and emergency department ( P < .001 ) services compared with those with public insurance .


When also adjusted for health insurance , greater financial burden was associated with more urgent office visits ( P < .001 ) and lower quality of life ( P < .001 ) .


African American women who perceive asthma as a financial burden regardless of health insurance report more urgent health care visits and lower quality of life .


Burden may be present despite having and being able to generate economic resources and health insurance .


Further policy efforts are indicated and special attention should focus on type of coverage .


The development and spread of Plasmodium falciparum resistance to most commonly used antimalarials remain a major challenge in the control of malaria .


Constant monitoring of drug efficacy is an important tool in establishing rational antimalarial drug policies .


A randomized comparative study was conducted at the Wesley Guild Hospital , Ilesa , Nigeria between February 2010 and September 2011 comparing the efficacy and safety of artemether-lumefantrine ( Coartem ) and fixed dose of artesunate plus amodiaquine ( Larimal ) in the treatment of uncomplicated P. falciparum malaria in children betweem 6 and 144 months of age .


P. falciparum malaria parasitemia was assessed by microscopy and rapid diagnostic test .


Drugs were administered according to age for three days under supervision .


The primary efficacy endpoint was a day 28 PCR-corrected parasitological cure .


A total of 182 patients were enrolled in the two treatment groups , Coartem ( n = 101 ) and Larimal ( n = 81 ) , and tested after 28 days .


In the intention-to-treat population , Coartem ( n = 101 ) and Larimal ( n = 81 ) had a PCR-corrected cure rate of 98 % and 100 % respectively , while in the per-protocol population , Coartem ( n = 89 ) and Larimal ( n = 71 ) both had a PCR-corrected cure rate of 100 % at day 28 .


Although parasite and fever clearance time was faster in the Larimal group , no significant difference was observed between the two drugs .


No serious adverse effects were reported .


Five years after being introduced in Nigeria , both Coartem and Larimal have been shown to be safe and highly effective in the treatment of uncomplicated P. falciparum malaria in children .


This double-blind , sham-controlled trial investigated the effects of two daily tDCS sessions over a 5-day period in treatment-resistant depression .


Twenty-four treatment-resistant depressed patients received two daily sessions of active or sham anodal tDCS to the left prefrontal cortex ( 2 mA , 10 sessions over 1 week ) .


Depression severity , psychomotor retardation and cognitive function were assessed .


Active tDCS was not significantly superior to sham tDCS on the HDRS at week 4 , as well as on the MADRS and SRRS scales , and on neuropsychological tests .


Response rates were not significantly higher with active tDCS .


tDCS was well tolerated , with mild adverse events limited to transient scalp discomfort .


tDCS did not induce clinically relevant antidepressant effect in active and sham stimulation groups .


There was no impact on psychomotor and neuropsychological functioning .


tDCS efficacy on specific symptom profiles in pharmacotherapy-resistant depression is limited .


The use of optimized stimulation protocol and longer period of follow up may valuably contribute to specify the place of tDCS in treatment-resistant depression .


The aim of this study was to evaluate the role of suture closure of the subcutaneous tissue in preventing wound complications after cesarean section with a Pfannenstiel incision , and to investigate factors associated with wound complications .


Patients undergoing cesarean delivery were randomly assigned to either suture closure or non-closure of the subcutaneous tissue .


The participants were invited to two follow-up examinations at the 1st and 4th postoperative weeks for the detection of wound complications .


The two main outcomes were composite wound complication and superficial wound separation .


Factors associated with wound complications were analyzed using multiple logistic regression .


During the study period , a total of 361 patients ( 176 in the closure group , 185 in non-closure group ) were analyzed .


Composite wound complication occurred in 23.3 % ( 41/176 ) of the closure group , and in 20 % ( 37/185 ) of the non-closure group with no significant difference ( P = 0.44 ) .


Wound separation occurred in 2.3 % ( 4/176 ) of the closure group and 1.6 % ( 3/185 ) of the non-closure group without any significant differences ( P = 0.64 ) .


None of the factors were found to be associated with the rate of composite complication .


The significant factors found to be associated with wound separation were subcutaneous tissue thickness of 4cm or more ( P = 0.01 ) and maternal diabetes mellitus ( P = 0.01 ) , however they lost their significance in multivariate analyses .


The rate of wound complications , including superficial wound separation , did not differ according to the subcutaneous closure in cesarean delivery with Pfannenstiel incision .


It is not possible to predict wound complications using previously defined clinical and operative risk factors , including subcutaneous tissue thickness .


To determine the effectiveness of a novel sonic toothbrush in reducing plaque and in maintenance of gingival health when compared to a standard manual brush .


This study was a block-randomized , examiner-blind , two-treatment , parallel group , single centre clinical investigation .


A total of 84 subjects were enrolled and randomly assigned to receive either the Panasonic EW-DL90 or an American Dental Association-endorsed manual toothbrush .


Subjects were instructed to follow a twice-daily brushing regimen without flossing .


Plaque levels and gingival health were assessed at baseline and after 1 and 3 weeks of treatment using the Turesky Modification of the Quigley-Hein Plaque Index and the Papillary Bleeding Score .


Subjects assigned to the EW-DL90 group had significantly lower plaque levels after 1 and 3 weeks of treatment than those in the manual group ( P = 0.003 and 0.0035 , respectively ) .


Both groups showed a reduction in plaque levels at Week 3 relative to baseline .


The EW-DL90 group had significantly lower gingival inflammation scores after 1 week of treatment ( P = 0.0293 ) , but there was no difference between groups after 3 weeks of treatment .


The EW-DL90 toothbrush safely and effectively removes more plaque than a standard manual toothbrush .


Improvement in gingival inflammation was observed after 1 week of treatment .


There was no difference in Papillary Bleeding Score between the two groups after 3 weeks of treatment .


The newly developed sonic brush ( Panasonic EW-DL90 ) tested in this study was found to be more effective than a manual toothbrush at plaque removal .


The papillary bleeding scores were significantly lower in the sonic brush group after 1 week of product use .


After 3 weeks of product use , both treatment groups had similar papillary bleeding scores almost returning to baseline values .


This study aimed to assess the effectiveness of Benson 's relaxation technique in improving the hemodialysis patients ' dietary and fluid adherence and biomedical markers .


This randomized controlled trial with a pre-post test design was conducted on 86 hemodialysis patients randomly divided into an intervention ( receiving Benson 's relaxation technique ) and a control group ( usual care ) .


The setting of the study was two hemodialysis units affiliated to Shiraz University of Medical Sciences , Shiraz , Iran .


The patients listened to the audiotape of Benson 's relaxation technique twice a day each time for 20min for 8 weeks .


Dietary and fluid adherence and some biomedical markers were measured in both the intervention and the control group at baseline and at the 8th week after the intervention .


The results showed significant differences between the two groups regarding blood urea nitrogen and phosphate as dietary adherence and interdialytic weight gain as fluid adherence in the 8th week of the intervention ( P < 0.05 ) .


Also , a significant difference was found between the two groups concerning blood glucose level after the intervention ( P < 0.05 ) .


This study highlighted the importance of Benson 's relaxation technique in improvement of adherence and some biomedical markers in hemodialysis patients .


Thus , Benson 's relaxation therapy could be used as a part of the nursing care practice for hemodialysis patients and those suffering from chronic diseases .


Early postnatal head growth failure is well recognized in very preterm infants ( VPIs ) .


This coincides with the characteristic nutritional deficits that occur in these parenteral nutrition ( PN ) dependent infants in the first month of life .


Head circumference ( HC ) is correlated with brain volume and later neurodevelopmental outcome .


We hypothesized that a Standardized , Concentrated With Added Macronutrients Parenteral ( SCAMP ) nutrition regimen would improve early head growth .


The aim was to compare the change in HC ( HC ) and HC SD score ( SDS ) achieved at day 28 in VPIs randomly assigned to receive SCAMP nutrition or a control standardized , concentrated PN regimen .


Control PN ( 10 % glucose , 2.8 g/kg per day protein/lipid ) was started within 6 hours of birth .


VPIs ( birth weight < 1200 g ; gestation < 29 weeks ) were randomly assigned to either start SCAMP ( 12 % glucose , 3.8 g/kg per day protein/lipid ) or remain on the control regimen .


HC was measured weekly .


Actual daily nutritional intake data were collected for days 1 to 28 .


There were no differences in demographic data between SCAMP ( n = 74 ) and control ( n = 76 ) groups .


Comparing cumulative 28-day intakes , the SCAMP group received 11 % more protein and 7 % more energy .


The SCAMP group had a greater HC at 28 days ( P < .001 ) .


The difference between the means ( 95 % confidence interval ) for HC was 5 mm ( 2 to 8 ) , and SDS was 0.37 ( 0.17 to 0.58 ) .


HC differences are still apparent at 36 weeks ' corrected gestational age .


Early postnatal head growth failure in VPIs can be ameliorated by optimizing PN .


Chronic shoulder pain ( CSP ) is the third most common type of musculoskeletal pain .


It has a major impact on health-related quality of life .


In Chinese medicine , CSP is considered one of the conditions most amenable to treatment with acupuncture .


The purpose of this study is to evaluate the efficacy of local acupoints in combination with distal acupoints in pain relief and shoulder function improvement in CSP patients .


This is a multicenter , single blind , factorial randomized controlled clinical trial .


A total of 164 participants will be randomly allocated to four different groups : Group A will receive acupuncture at local acupoints in combination with distal acupoint .


Group B will receive acupuncture at local acupoints in combination with distal non-acupoint .


Group C will receive acupuncture at local non-acupoints in combination with distal acupoint .


Group D will receive acupuncture at local non-acupoints in combination with distal non-acupoint .


Each group will receive 12 treatments of acupuncture one to three times per week for six weeks in total .


The primary outcome is shoulder pain intensity , which is graded using a 100 - mm Visual Analogue Scale .


The assessment is at baseline ( before treatment initiation ) , 6weeks after the first acupuncture , 10weeks after the first acupuncture and 18weeks after the first acupuncture .


This trial will be helpful in identifying whether acupuncture at local acupoints in combination with distal acupoints may be more effective than needling points separately .


International Standard Randomized Controlled Trial Number Register : ISRCTN61861069 ( http://www.controlled-trials.com ) .


Rivaroxaban is an oral , direct Factor Xa inhibitor , approved for the treatment of pulmonary embolism ( PE ) and deep vein thrombosis ( DVT ) and the secondary prevention of recurrent PE and DVT as a fixed-dose , monotherapy regimen that does not require initial heparinisation , routine coagulation monitoring or dose adjustment .


Approval in this indication was supported by results from EINSTEIN PE , a large , randomised , open-label study that compared rivaroxaban with enoxaparin/vitamin K antagonist ( VKA ) therapy in patients with acute symptomatic PE with or without DVT .


Patient-reported treatment satisfaction was evaluated in a predefined subanalysis of EINSTEIN PE to enable monitoring and optimisation of patient-reported outcomes and , therefore , patient compliance .


As part of EINSTEIN PE , 2,397 patients in seven countries were asked to complete a validated measure of treatment satisfaction , the Anti-Clot Treatment Scale ( ACTS ) throughout the duration of treatment ( up to 12 months ) .


Patients reported greater satisfaction in the rivaroxaban treatment arm as compared with the enoxaparin/VKA treatment arm .


Treatment with rivaroxaban was reported as being significantly less burdensome than enoxaparin/VKA therapy , and the benefits of treatment were significantly greater .


Rivaroxaban treatment resulted in improved treatment satisfaction compared with enoxaparin/VKA in PE patients , particularly in reducing patient-reported anticoagulation burden .


A sub-study to evaluate safety , tolerability , ease-of-use and patient satisfaction with a single-use autoinjector administering subcutaneous peginterferon-1a ( a pegylated interferon-1a in clinical development ) in a subset of relapsing-remitting multiple sclerosis ( MS ) patients participating in ATTAIN , a long-term dose-frequency blinded extension of the Phase III randomized ADVANCE study .


Over 8 weeks , patients self-administered peginterferon-1a 125 g or placebo every 2 weeks ( two injections via manual pre-filled syringe [ PFS ] ; two injections via single-use autoinjector ) .


Primary end points were incidence of adverse events ( AEs ) , patient assessment of injection pain score ( 10-point Visual Analog Scale ) , and clinician assessment of injection site reactions ( ISRs ) .


Secondary objectives included patient assessment of ease-of-use and satisfaction with the autoinjector and evaluation of autoinjector training materials .


In 39 patients , the safety profile of peginterferon-1a was similar when delivered via autoinjector or PFS ; AEs were mostly mild or moderate in severity .


Clinicians and patients reported a similar tolerability profile using both PFS and autoinjector , and pain scores were low ( < 1 ) , with no reports of clinician-assessed ISRs after administration with the autoinjector .


Patients perceived the single-use autoinjector to be easy to use and convenient ; overall patient satisfaction with the autoinjector and accompanying training materials was high .


The safety and tolerability profile of peginterferon-1a delivered via autoinjector was similar to delivery via PFS .


Patients found the autoinjector easy to use and convenient ; this device may simplify the injection process for MS patients who require long-term therapy , thereby potentially improving patient 's quality of life and adherence .


To demonstrate the safety and efficacy of up to 5 years of degarelix treatment and the effects of crossing over from leuprolide to degarelix in the extension phase of a phase III pivotal 1-year trial .


Patients receiving degarelix who completed the 1-year trial continued on 80 mg ( n = 125 ) or 160 mg ( n = 126 ) maintenance doses .


Patients who received leuprolide were rerandomized to degarelix 240/80 mg ( n = 69 ) or 240/160 mg ( n = 65 ) .


Safety and tolerability were assessed ( primary end point ) , as well as testosterone and prostate-specific antigen levels and prostate-specific antigen progression-free survival ( secondary end points ) .


Adverse event frequency was similar between both the groups .


Adverse events included initial injection site reactions , hot flushes , and increased weight .


Testosterone and prostate-specific antigen values during the extension study were similar to those seen during the 1-year trial in patients who continued on degarelix or crossed over from leuprolide .


The prostate-specific antigen progression-free survival hazard rate was decreased significantly after the crossover in the leuprolide to degarelix group ( from 0.20 to 0.09 ; P = .002 ) , whereas in patients who continued on degarelix , the rate did not change significantly .


In patients with baseline prostate-specific antigen > 20 ng/mL , the same hazard rate change pattern was observed on crossover ( from 0.38 to 0.19 ; P = .019 ) .


Degarelix was well tolerated ; no safety concerns were identified .


The significant prostate-specific antigen progression-free survival benefit established for degarelix over leuprolide during year 1 remained consistent at 5 years .


Oral biofilm formation and progression on the surface of the tooth can lead to advanced oral disease such as gingivitis .


The purpose of this randomized , controlled , double-blinded study was to evaluate the effects of a novel dental gel on oral plaque biofilm using multimodal imaging techniques .


Twenty-five subjects with moderate gingival inflammation ( Le and Silness Gingival Index 2 ) and pocket depths < 4 were randomly assigned to brush twice daily for 21 days with the test or the control dental gel .


In vivo multimodality in situ imaging was performed over a 3-week period using in vivo Optical Coherence Tomography ( OCT ) and Non-Linear Optical microscopy ( NLOM ) .


Plaque levels , gingival inflammation and gingival bleeding were also charted on days 0 , 7 , 14 , and 21 using standard clinical indices .


After 3 weeks , OCT and NLOM images showed a macroscopic break-up of the plaque layer and smaller , fragmented residual deposits in the test group with no apparent changes in the pellicle .


Biofilm was also reduced in the control group , but to a lesser degree with regard to thickness , continuity and surface area .


Paralleling these imaging results , clinical indices were significantly improved in both groups ( P < 0.05 ) and significantly lower in the test group ( P < 0.05 ) .


Both dental gels reduced oral biofilm with the test gel showing greater efficacy ( P < 0.05 ) as determined by clinical and imaging parameters .


This study examined the impact of pictorial cigarette-warning labels , warning-label message framing and plain cigarette packaging , on young adult smokers ' motivation to quit .


Smokers aged 18-30 years ( n = 740 ) from a consumer research panel were randomised to one of four experimental conditions where they viewed online images of four cigarette packs with warnings about lung disease , cancer , stroke/heart disease and death , respectively .


Packs differed across conditions by warning-message framing ( gain vs loss ) and packaging ( branded vs plain ) .


Measures captured demographics , smoking behaviour , covariates and motivation to quit in response to cigarette packs .


Pictorial warnings about lung disease and cancer generated the strongest motivation to quit across conditions .


Adjusting for pretest motivation and covariates , a message framing by packaging interaction revealed gain-framed warnings on plain packs generated greater motivation to quit for lung disease , cancer and mortality warnings ( p < 0.05 ) , compared with loss-framed warnings on plain packs .


Warnings combining pictorial depictions of smoking-related health risks with text-based messages about how quitting reduces risks , may achieve better outcomes among young adults , especially in countries considering or implementing plain packaging regulations .


The aim of this study was to investigate the effects of CO2 insufflation on the pressure of the middle ear cavity ( PMEC ) during laparoscopic surgery under total intravenous anesthesia ( TIVA ) with propofol or sevoflurane as an inhalational anesthetic maintenance .


Sixty patients who underwent laparoscopic/or non-laparoscopic surgery under general anesthesia were included in the study .


For anesthetic maintenance with inhalation agents , 20 non-laparoscopic surgery patients in Group 1 were applied sevoflurane ( 2-2 .5 % ) .


Forty patients who underwent laparoscopic surgery were randomized into two groups .


Anesthesia was maintained with sevoflurane ( 2-2 .5 % ) in twenty patients in Group 2 and the TIVA technique in 20 patients in Group 3 .


In Group 1 , PMEC was measured before anesthesia , 10 and 30 min after endotracheal intubation , 10 min before extubation , and 15 , 30 , 60 min and 6 hours in the postoperative period .


In Group 2 and 3 , PMEC was measured before the anesthesia , 10 min after intubation , 10 and 30 min after CO2 insufflation , just before the CO2 elimination , 10 min before the extubation , and 15 , 30 , 60 min and 6 hours after extubation in the postoperative period .


PMEC was significantly increased in Group 1 at 10 min after intubation , at 30 min of the operation , before extubation , and at postoperative 15 and 30 min ( p < 0.05 ) .


In Group 3 , differences between PMECs were detected at the 30th min of insufflation ( p = 0.005 ) , and during elimination ( p = 0.035 ) compared to the initial measurement .


Generally , the values remained positive in Group 1 and negative in Group 3 .


There was a significant difference between Group 1 and Group 3 at 10 min after the induction ( p = 0.001 ) .


There was no statistically significant difference in PMECs between Group 2 and 3 patients undergoing laparoscopic surgery .


Our results indicate that , in laparoscopic surgery , TIVA used for the maintenance of anesthesia did not increase the PMEC and the changes caused by sevoflurane were also in the normal range of middle ear pressures .


In patients with previous ear surgery , if there is a need of classical surgical procedures in the future , sevoflurane anesthesia should not be the first choice due to its effects on PMEC , which cause it to be increased over 50 daPa , especially at 30 min after intubation .


Patient characteristics including previous ear surgery should be considered in selecting the optimum anesthetic agents and technique .


It has been suggested that statins have an effect on the modulation of the cytokine cascade and on the outcome of patients with community-acquired pneumonia ( CAP ) .


The aim of this prospective , randomised , double-blind , placebo-controlled trial was to determine whether statin therapy given to hospitalised patients with CAP improves clinical outcomes and reduces the concentration of inflammatory cytokines .


A tertiary teaching hospital in Barcelona , Spain .


Thirty-four patients were randomly assigned and included in an intention-to-treat analysis ( 19 to the simvastatin group and 15 to the placebo group ) .


Patients were randomly assigned to receive 20mg of simvastatin or placebo administered in the first 24h of hospital admission and once daily thereafter for 4days .


Primary end point was the time from hospital admission to clinical stability .


The secondary end points were serum concentrations of inflammatory cytokines and partial pressure of arterial oxygen/fractional inspired oxygen ( PaO2/FiO2 ) at 48h after treatment administration .


The trial was stopped because enrolment was much slower than originally anticipated .


The baseline characteristics of the patients and cytokine concentrations at the time of enrolment were similar in the two groups .


No significant differences in the time from hospital admission to clinical stability were found between study groups ( median 3days , IQR 2-5 vs 3days , IQR 2-5 ; p = 0.47 ) .


No significant differences in PaO2/FiO2 ( p = 0.37 ) , C reactive protein ( p = 0.23 ) , tumour necrosis factor - ( p = 0.58 ) , interleukin 6 ( IL-6 ; p = 0.64 ) , and IL-10 ( p = 0.61 ) levels at 48h of hospitalisation were found between simvastatin and placebo groups .


Similarly , transaminase and total creatine kinase levels were similar between study groups at 48h of hospitalisation ( p = 0.19 , 0.08 and 0.53 , respectively ) .


Our results suggest that the use of simvastatin , 20mg once daily for 4days , since hospital admission did not reduce the time to clinical stability and the levels of inflammatory cytokines in hospitalised patients with CAP .


ISRCTN91327214 .


The emergence of HIV as a chronic condition means that people living with HIV are required to take more responsibility for the self-management of their condition , including making physical , emotional and social adjustments .


This paper describes the design and evaluation of Positive Outlook , an online program aiming to enhance the self-management skills of gay men living with HIV .


This study is designed as a randomised controlled trial in which men living with HIV in Australia will be assigned to either an intervention group or usual care control group .


The intervention group will participate in the online group program ` Positive Outlook ' .


The program is based on self-efficacy theory and uses a self-management approach to enhance skills , confidence and abilities to manage the psychosocial issues associated with HIV in daily life .


Participants will access the program for a minimum of 90 minutes per week over seven weeks .


Primary outcomes are domain specific self-efficacy , HIV related quality of life , and outcomes of health education .


Secondary outcomes include : depression , anxiety and stress ; general health and quality of life ; adjustment to HIV ; and social support .


Data collection will take place at baseline , completion of the intervention ( or eight weeks post randomisation ) and at 12 week follow-up .


Results of the Positive Outlook study will provide information regarding the effectiveness of online group programs improving health related outcomes for men living with HIV .


ACTRN12612000642886 .


Despite significant increases in global health investment and the availability of low-cost , efficacious interventions to prevent mother-to-child HIV transmission ( pMTCT ) in low - and middle-income countries with high HIV burden , the translation of scientific advances into effective delivery strategies has been slow , uneven and incomplete .


As a result , pediatric HIV infection remains largely uncontrolled .


A five-step , facility-level systems analysis and improvement intervention ( SAIA ) was designed to maximize effectiveness of pMTCT service provision by improving understanding of inefficiencies ( step one : cascade analysis ) , guiding identification and prioritization of low-cost workflow modifications ( step two : value stream mapping ) , and iteratively testing and redesigning these modifications ( steps three through five ) .


This protocol describes the SAIA intervention and methods to evaluate the intervention 's impact on reducing drop-offs along the pMTCT cascade .


This study employs a two-arm , longitudinal cluster randomized trial design .


The unit of randomization is the health facility .


A total of 90 facilities were identified in Cte d'Ivoire , Kenya and Mozambique ( 30 per country ) .


A subset was randomly selected and assigned to intervention and comparison arms , stratified by country and service volume , resulting in 18 intervention and 18 comparison facilities across all three countries , with six intervention and six comparison facilities per country .


The SAIA intervention will be implemented for six months in the 18 intervention facilities .


Primary trial outcomes are designed to assess improvements in the pMTCT service cascade , and include the percentage of pregnant women being tested for HIV at the first antenatal care visit , the percentage of HIV-infected pregnant women receiving adequate prophylaxis or combination antiretroviral therapy in pregnancy , and the percentage of newborns exposed to HIV in pregnancy receiving an HIV diagnosis eight weeks postpartum .


The Consolidated Framework for Implementation Research ( CFIR ) will guide collection and analysis of qualitative data on implementation process .


This study is a pragmatic trial that has the potential benefit of improving maternal and infant outcomes by reducing drop-offs along the pMTCT cascade .


The SAIA intervention is designed to provide simple tools to guide decision-making for pMTCT program staff at the facility level , and to identify low cost , contextually appropriate pMTCT improvement strategies .


ClinicalTrials.gov NCT02023658 .


To assess the impact of a web-based intervention supplemented with text messages to reduce cancer risk linked with smoking , unhealthy diet , alcohol consumption , obesity , sedentary lifestyle and sun exposure .


A total of 2001 voluntary adolescents from Spain and Mexico were recruited between 2009 and 2012 and randomly assigned to : one control group and two experimental groups , which received exclusively the online intervention ( experimental group 1 ) or the intervention supplemented with encouraging text messages ( experimental group 2 ) .


The educational intervention was based on both : successful psychosocial models ( i.e. A.S.E. and Transtheoretical model ) and the school curriculum .


After a 9-month follow-up , the prevalence of students who did not eat fruit was reduced significantly in all groups : experimental group 1 ( -62.6 % ) , experimental group 2 ( -71.5 % ) and even the control group ( -66.8 % ) .


Being overweight was only reduced in the experimental group 2 ( -19.6 % ) .


The total cancer behavioral risk score , which ranged from 0 to 100 points ( highest risk ) , was significantly reduced in the experimental group 1 ( -3.5 points ) and in the experimental group 2 ( -5.3 points ) .


The text-supplemented online intervention increased the probability of improving the post-test total cancer behavioral risk ( OR = 1.62 ) .


The web-based intervention supplemented with text messages had a positive global impact , but it lead to only minimal changes in risky behaviors .


This intervention appears useful in controlling overweight adolescents .


ISRCTN27988779 .


To establish the efficacy of prophylactic nifedipine vs. placebo in reducing spontaneous preterm delivery in asymptomatic women at high risk for preterm delivery .


Prospective multicentric randomized double-blind study .


Tertiary care centre , University Hospitals of Brescia and Torino , Italy .


Eighty-seven singleton pregnancies without uterine contractions and ultrasonographic cervical length of 25mm at 24-32weeks , at risk for preterm delivery , with longitudinal follow up in our Preterm Prevention Clinic .


Selection was done on the basis of ultrasonographic cervical length ; 43 women were randomized to receive placebo and 44 to receive nifedipine .


Primary end point : spontaneous preterm delivery < 37weeks in nifedipine vs. placebo .


delivery < 32weeks , maternal side effects , neonatal complications , admissions to the Neonatal Intensive Care Unit and randomization/delivery time in nifedipine vs. placebo .


There was no trend towards a lower risk of spontaneous preterm delivery , neither at < 37weeks of nifedipine vs. placebo ( 11.4 % vs. 19.0 % ; p = 0.320 ) , or < 32weeks ( 2.3 % vs. 2.4 % ; p = 0.973 ) .


Nifedipine reduced spontaneous preterm delivery < 37weeks ( p = 0.015 ) in the multiparous women by stratified analysis for parity .


SECONDARY OUTCOMES between the groups did not differ except for a higher percentage of maternal side-effects in the nifedipine group ( 31.8 % ) vs. placebo ( 11.9 % ) ( p < 0.05 ) .


Subgroup analysis showed a borderline ( p = 0.047 ) lower percentage of spontaneous preterm delivery in women with a ultrasonographic cervical length of < 20mm in the nifedipine group .


Prophylactic nifedipine in asymptomatic women at high risk for preterm delivery had a positive effect on the rate of spontaneous preterm delivery < 37weeks in multiparous women .


We compared the activity of denosumab with zoledronic acid for delaying or preventing hypercalcaemia of malignancy ( HCM ) in patients with advanced cancer and bone metastases or with multiple myeloma .


Patient-level data were combined from two identically designed , randomised , double-blind , active-controlled , phase III trials of advanced cancer patients with breast cancer and other solid tumours ( excluding breast or prostate cancer ) or multiple myeloma .


End-points included time to first on-study HCM , time to first and subsequent on-study HCM , proportion of patients experiencing HCM and proportion of patients experiencing recurrent HCM .


Denosumab significantly delayed the time to first on-study HCM , representing a 37 % reduction in the hazard ratio ( HR ) compared with zoledronic acid ( HR , 0.63 ; 95 % confidence interval ( CI ) : 0.41-0 .98 ; P = 0.042 ) and reduced the risk of developing recurrent HCM ( time to first and subsequent on-study HCM ) by 52 % ( rate ratio , 0.48 ; 95 % CI : 0.29-0 .81 ; P = 0.006 ) .


The median time on study was 12.9 months .


Fewer patients receiving denosumab compared with zoledronic acid experienced an HCM event ( 1.7 % versus 2.7 % ; P = 0.028 ) .


Of the 84 patients experiencing an HCM event , 40 % of those receiving zoledronic acid experienced > 1 event of HCM compared with 31 % of those receiving denosumab .


Denosumab treatment was more efficacious than treatment with zoledronic acid in delaying or preventing HCM in advanced cancer patients with breast cancer , other solid tumours or multiple myeloma .


Malignant pleural mesothelioma incidence continues to rise , with few available evidence-based therapeutic options .


Results of previous non-randomised studies suggested that video-assisted thoracoscopic partial pleurectomy ( VAT-PP ) might improve symptom control and survival .


We aimed to compare efficacy in terms of overall survival , and cost , of VAT-PP and talc pleurodesis in patients with malignant pleural mesothelioma .


We undertook an open-label , parallel-group , randomised , controlled trial in patients aged 18 years or older with any subtype of confirmed or suspected mesothelioma with pleural effusion , recruited from 12 hospitals in the UK .


Eligible patients were randomly assigned ( 1:1 ) to either VAT-PP or talc pleurodesis by computer-generated random numbers , stratified by European Organisation for Research and Treatment of Cancer risk category ( high vs low ) .


The primary outcome was overall survival at 1 year , analysed by intention to treat ( all patients randomly assigned to a treatment group with a final diagnosis of mesothelioma ) .


This trial is registered with ClinicalTrials.gov , number NCT00821860 .


Between Oct 24 , 2003 , and Jan 24 , 2012 , we randomly assigned 196 patients , of whom 175 ( 88 assigned to talc pleurodesis , 87 assigned to VAT-PP ) had confirmed mesothelioma .


Overall survival at 1 year was 52 % ( 95 % CI 41-62 ) in the VAT-PP group and 57 % ( 46-66 ) in the talc pleurodesis group ( hazard ratio 104 [ 95 % CI 076-142 ] ; p = 081 ) .


Surgical complications were significantly more common after VAT-PP than after talc pleurodesis , occurring in 24 ( 31 % ) of 78 patients who completed VAT-PP versus ten ( 14 % ) of 73 patients who completed talc pleurodesis ( p = 0019 ) , as were respiratory complications ( 19 [ 24 % ] vs 11 [ 15 % ] ; p = 022 ) and air-leak beyond 10 days ( five [ 6 % ] vs one [ 1 % ] ; p = 021 ) , although not significantly so .


Median hospital stay was longer at 7 days ( IQR 5-11 ) in patients who received VAT-PP compared with 3 days ( 2-5 ) for those who received talc pleurodesis ( p < 00001 ) .


VAT-PP is not recommended to improve overall survival in patients with pleural effusion due to malignant pleural mesothelioma , and talc pleurodesis might be preferable considering the fewer complications and shorter hospital stay associated with this treatment .


BUPA Foundation .


To compare the effects of 2 suturing techniques ( single versus double layer ) on healing of the uterine scar after a cesarean delivery .


In the present randomized , prospective study , 36 women with a term pregnancy who had an elective cesarean delivery were randomly assigned to closure of the uterine incision with a single-layer locked suture or with a double-layer locked/unlocked suture .


Six months after the operation , the integrity of the cesarean scar at the uterine incision site was assessed by hydrosonography .


The healing ratio and the thickness of the residual myometrium covering the defect were calculated as markers of uterine scar healing .


There were no significant differences between the groups in terms of estimated blood loss , operation time , or additional hemostatic suture .


However , the mean thickness of the residual myometrium covering the defect was 9.95 1.94 mm after a double-layer closure and 7.53 2.54 mm after a single-layer closure ( P = 0.005 ) .


The mean healing ratio was significantly higher after a double-layer closure ( 0.83 0.10 ) than after a single-layer closure ( 0.67 0.15 ; P = 0.004 ) .


A double-layer locked/unlocked closure of the uterine incision at cesarean delivery decreases the risk of poor uterine scar healing .


To evaluate the feasibility and preliminary efficacy of a Web-based tobacco treatment for persons living with HIV ( PLWH ) .


Prospective , randomized controlled trial .


HIV-care center in the Bronx , New York .


Eligibility criteria included HIV infection , current tobacco usage , interest in quitting , and access to a computer with internet .


One hundred thirty-eight subjects enrolled , and 134 completed the study .


Positively Smoke Free on the Web ( PSFW ) , an 8-session , 7-week targeted tobacco treatment program for PLWH , was compared with standard care ( brief advice to quit and self-help brochure ) .


All subjects were offered nicotine patches .


The main feasibility outcomes were number of sessions logged into , number of Web pages visited , number of interactive clicks , and total time logged in .


The main efficacy outcome was biochemically verified , 7-day point prevalence abstinence 3 months after intervention .


PSFW subjects logged into a mean of 5.5 of 8 sessions and 26.2 of 41 pages .


They executed a mean of 10 interactive clicks during a mean total of 59.8 minutes logged in .


Most required reminder phone calls to complete the sessions .


Educational level , anxiety score , and home access of the Web site were associated with Web site usage .


Ten percent of the PSFW group vs. 4.3 % of controls achieved the abstinence end point .


Among those who completed all 8 sessions , 17.9 % were abstinent , and among women completers , 30.8 % were abstinent .


Web-based treatment is a feasible strategy for PLWH smokers , and preliminary findings suggest therapeutic efficacy .


Some studies have shown the beneficial effects of yoga for individuals with bronchial hyperreactivity with regard to ( 1 ) a reduction in the use of rescue medication , ( 2 ) an increase in exercise capacity , and ( 3 ) an improvement in lung function .


Despite the fact that yoga is promising as a new treatment for pediatric patients , further studies are needed to assess the use of this training for asthma management .


This study was performed to assess the beneficial effects of yoga in exercise-induced bronchoconstriction ( EIB ) in children .


The study was prospective , with no control group .


Participants were randomly chosen among the new patients at the unit .


This study was conducted in the Erciyes University School of Medicine , Pediatric Allergy Unit , in Kayseri , Turkey .


Two groups of asthmatic children aged 6-17 y were enrolled in the study : ( 1 ) children with positive responses to an exercise challenge ( n = 10 ) , and ( 2 ) those with negative responses ( n = 10 ) .


Both groups attended 1-h sessions of yoga training 2 / wk for 3 mo. .


Researchers administered spirometric measurement to all children before and immediately after participating in an exercise challenge .


This process was performed at baseline and at the study 's end .


Age , gender , IgE levels , eosinophil numbers , and spirometric measurement parameters including forced expiratory volume in 1 sec ( FEV1 ) , forced expiratory flow 25 % -75 % ( FEF25 % -75 % ) , forced vital capacity ( FVC ) , peak expiratory flow percentage ( PEF % ) , and peak expiratory flow rate ( PEFR ) were compared using the Mann-Whitney U test and the Wilcoxon test .


A P value < .05 was considered significant .


At baseline , no significant differences were observed between the groups regarding demographics or pre-exercise spirometric measurements ( P > .05 , Mann-Whitney U test ) .


Likewise , no significant differences in spirometric measurements existed between the groups regarding the change in responses to an exercise challenge after yoga training ( P > .05 , Wilcoxon test ) .


For the exercise-response-positive group , the research team observed a significant improvement in maximum forced expiratory volume 1 % ( FEV1 % ) fall following the exercise challenge after yoga training ( P > .05 , Wilcoxon test ) .


All exercise-response-positive asthmatics became exerciseresponse-negative asthmatics after yoga training .


This study showed that training children in the practice of yoga had beneficial effects on EIB .


It is the research team 's opinion that yoga training can supplement drug therapy to achieve better control of asthma .


The aim of this study was to compare the recurrence of esophageal varices ( EVs ) after endoscopic band ligation ( EBL ) associated with propranolol ( PP ) versus EBL alone .


Sixty-six cirrhotic outpatients ( EBL group , n = 32 and EBL+PP group , n = 34 ) with high-risk EVs without previous bleeding were studied .


The primary outcome was recurrence of EV .


The secondary outcomes were EV eradication , bleeding before EV eradication , mortality , and adverse events .


Demographic characteristics and the initial endoscopic findings were similar .


EV eradication was achieved in all patients .


Three patients presented gastrointestinal bleeding before variceal eradication , two in the EBL group and one in the EBL+PP group ( P = 0.13 ) .


Six patients died ( liver failure ) , two in the EBL group and four in the EBL+PP group ( P = 0.27 ) .


Twelve ( 38 % ) patients in the EBL group and three ( 9 % ) patients in the EBL+PP group had variceal recurrence .


The risk of recurrence of EVs after eradication was significantly higher among patients in the EBL group ( P = 0.003 ) .


EBL alone and EBL+PP were effective in the primary prophylaxis of bleeding from EVs in cirrhotic patients ( EV eradication , bleeding before EV eradication , mortality , and adverse events were similar in both groups ) .


However , variceal recurrence was lower in the EBL+PP group than band ligation alone .


Fibromyalgia is a common chronic pain condition that has a significant impact on quality of life and often leads to disability .


To date , there have been few well-controlled trials assessing the utility of nonpharmacological treatment modalities such as transcutaneous electrical nerve stimulation ( TENS ) in the management of pain and improvement in function in individuals with fibromyalgia .


The purpose of this study will be to complete a long-term , multicenter study to assess the effects of TENS in women with fibromyalgia .


This will be a phase II randomized , double-blind , placebo-controlled , multicenter clinical trial .


Three hundred forty-three participants with fibromyalgia will be recruited for this study .


Participants will be randomly assigned to 1 of 3 groups : the intervention ( TENS ) , placebo , or no treatment .


After completing the randomized period , all participants will receive the intervention for 1 month .


The participants will be asked to use TENS at the highest tolerable level for at least 2 hours daily during physical activity .


The primary outcome will be pain with movement , with secondary outcomes assessing functional abilities , patient-reported outcomes , and quantitative sensory testing .


Because having participants refrain from their typical medications is not practical , their usage and any change in medication use will be recorded .


The results of this study will provide some of the first evidence from a large-scale , double-blind , placebo-controlled trial on the effectiveness of TENS on pain control and quality-of-life changes in patients with fibromyalgia .


In Sub-Saharan Africa over one million newborns die annually .


We developed a sustainable and scalable home-based counselling intervention for delivery by community volunteers in rural southern Tanzania to improve newborn care practices and survival .


Here we report the effect on newborn care practices one year after full implementation .


All 132 wards in the 6-district study area were randomised to intervention or comparison groups .


Starting in 2010 , in intervention areas trained volunteers made home visits during pregnancy and after childbirth to promote recommended newborn care practices including hygiene , breastfeeding and identification and extra care for low birth weight babies .


In 2011 , in a representative sample of 5,240 households , we asked women who had given birth in the previous year both about counselling visits and their childbirth and newborn care practices .


Four of 14 newborn care practices were more commonly reported in intervention than comparison areas : delaying the baby 's first bath by at least six hours ( 81 % versus 68 % , OR 2.0 ( 95 % CI 1.2-3 .4 ) ) , exclusive breastfeeding in the three days after birth ( 83 % versus 71 % , OR 1.9 ( 95 % CI 1.3-2 .9 ) ) , putting nothing on the cord ( 87 % versus 70 % , OR 2.8 ( 95 % CI 1.7-4 .6 ) ) , and , for home births , tying the cord with a clean thread ( 69 % versus 39 % , OR 3.4 ( 95 % CI 1.5-7 .5 ) ) .


For other behaviours there was little evidence of differences in reported practices between intervention and comparison areas including childbirth in a health facility or with a skilled attendant , thermal care practices , breastfeeding within an hour of birth and , for home births , the birth attendant having clean hands , cutting the cord with a clean blade and birth preparedness activities .


A home-based counselling strategy using volunteers and designed for scale-up can improve newborn care behaviours in rural communities of southern Tanzania .


Further research is needed to evaluate if , and at what cost , these gains will lead to improved newborn survival .


Trial Registration Number NCT01022788 ( http://www.clinicaltrials.gov , 2009 ) .


To investigate the relationships between AMG 811 exposure , concentration changes in serum IFN - , and IFN -- induced protein 10 ( CXCL10 ) , and to identify important contributions of baseline covariates to these relationships .


A mechanism based pharmacokinetic ( PK ) - pharmacodynamic ( PD ) model was developed .


A target mediated disposition model was used to describe AMG 811 and target IFN - interaction .


CXCL10 was predicted to be driven by estimated free IFN - levels .


For an average systemic lupus erythematosus ( SLE ) subject , the linear clearance ( CL ) of AMG 811 was 0.176 L/day , and the central ( Vc ) and peripheral ( Vp ) volumes of distribution were 1.48 and 2.12 L , respectively .


Body weight was found to correlate with CL , Vc , Vp , and inter compartment clearance ( Q ) ; and age was found to correlate with Vc .


The relationship between estimated free serum IFN - concentration levels and serum CXCL10 in logarithmic scales was best described by a linear model with slope and intercept estimated to be 0.197 and -0.3 , respectively .


The largest observed reduction of serum CXCL10 concentration was achieved at the highest AMG 811 dose tested ( 180 mg SC ) .


This model enables simulations of AMG 811 PK-PD profiles under various dosing regimens to support future clinical studies .


We evaluated whether stress levels in children and parents during radiological evaluation after febrile urinary tract infection are really lower using the top-down approach , where ( 99m ) technetium dimercaptosuccinic acid renal scintigraphy is used initially , than the bottom-up approach , where voiding cystourethrography is initially performed and repeated examinations are easier for all .


We prospectively evaluated 120 children 3 to 8 years old .


Pain ratings were obtained using the Faces Pain Scale-Revised , and conversation during the procedure was evaluated using the Child-Adult Medical Procedure Interaction Scale-Revised by 2 independent observers .


To evaluate parental anxiety , the State-Trait Anxiety Inventory form was also completed .


Following a documented febrile urinary tract infection children were randomized to the top-down or bottom-up group .


A third group of 44 children undergoing repeat voiding cystourethrography and their parents were also evaluated .


Child ratings of pain using the Faces Pain Scale-Revised were not significantly different between the top-down group following ( 99m ) technetium dimercaptosuccinic acid renal scintigraphy ( 2.99 on a scale of 10 ) and the bottom-up group following voiding cystourethrography ( 3.21 ) .


Also the Faces Pain Scale-Revised was not significantly different in the repeat voiding cystourethrography group ( 3.35 ) .


On the Child-Adult Medical Procedure Interaction Scale-Revised there was negative correlation between child coping and child distress , as well as rate of child distress and adult coping promoting behavior .


Parental state anxiety scores were significantly less in the top-down and repeat voiding cystourethrography groups than in the bottom-up group .


Although the top-down approach and repeat voiding cystourethrography cause less anxiety for caregivers , these values do not correlate to pain scale in children .


This finding might be due to lack of appropriate evaluation tools of pediatric pain and anxiety .


However , the theory that the top-down approach is less invasive , and thus less stressful , requires further research .


The Child-Adult Medical Procedure Interaction Scale-Revised data indicate that influences in adult-child interaction are bidirectional .


Atelectasis is common during and after general anaesthesia .


We hypothesized that a ventilation strategy with a combination of 1 ) continuous positive airway pressure ( CPAP ) or positive end-expiratory pressure ( PEEP ) and 2 ) a reduced end-expiratory oxygen concentration during recovery would reduce post-operative atelectasis .


Sixty patients were randomized into two groups .


During anaesthesia induction , inspiratory oxygen fraction ( FIO2 ) was 1.0 , and depending on weight , CPAP 6 , 7 or 8 cmH2O was applied in both groups via facemask .


During maintenance of anaesthesia , a laryngeal mask airway ( LMA ) was used , and PEEP was 6-8 cmH2O in both groups .


Before removal of the LMA , FIO2 was set to 0.3 in the intervention group and 1.0 in the control group .


Atelectasis was studied by computed tomography ( CT ) approximately 14 min post-operatively .


In one patient in the group given an FIO2 of 0.3 before removal of the LMA a CT scan could not be performed so the patient was excluded .


The area of atelectasis was 5.5 , 0-16 .9 cm ( 2 ) ( median and range ) , and 6.8 , 0-27 .5 cm ( 2 ) in the groups given FIO2 0.3 or FIO2 1.0 before removal of the LMA , a difference that was not statistically significant ( P = 0.48 ) .


Post-hoc analysis showed dependence of atelectasis on smoking ( despite all were clinically lung healthy ) and American Society of Anesthesiologists class ( P = 0.038 and 0.015 , respectively ) .


Inducing anaesthesia with CPAP/PEEP and FIO2 1.0 and deliberately reducing FIO2 during recovery before removal of the LMA did not reduce post-operative atelectasis compared with FIO2 1.0 before removal of the LMA .


A classic general anesthesia is performed by induction with an intravenous hypnotic ( such as propofol ) and maintenance with a volatile anesthetic ( such as sevoflurane ) .


The aim of the present study was to compare the effects of a propofol/sevoflurane maintenance regimen with that of a sevoflurane regimen on recovery profiles .


One hundred and sixty patients , who were ASA 1 or 2 , 45-65 years of age , and scheduled for elective gastrointestinal surgery under combined general/epidural anesthesia , were allocated randomly to receive the sevoflurane maintenance regimen ( group S , n = 80 ) or sevoflurane/propofol regimen ( group SP , n = 80 ) .


After induction , anesthesia was maintained with sevoflurane in group S and sevoflurane with propofol ( 1.2 g/ml target plasma concentration ) in group SP .


Bispectral index ( BIS ) values were maintained within 40-60 during the maintenance .


Time to extubation , incidence of serious coughing and agitation , and other recovery characteristics were evaluated during emergence .


The time to awakening and extubation in group SP were 7.2 2 min and 8.0 1.8 min , respectively , which were shorter than those results in group S ( 12.3 1.5 and 12.8 1.6 min , respectively ) ( P < 0.05 ) .


The incidence of serious coughing and agitation in SP ( 30 % and 25 % ) was lower than that of group S ( 68 % and 53 % ) ( P < 0.05 ) .


BIS value , pain score , requirements of analgesics and antiemetics in the PACU , and length of stay in the PACU were similar in the two groups .


Compared to sevoflurane maintenance , coadministration of propofol and sevoflurane provides faster awakening and extubation with a low incidence of emergence coughing and agitation .


To compare two intrathecal anaesthetics , bupivacaine and levobupivacaine , for their effects on motor and sensory blockade and haemodynamics in patients aged 65 years undergoing transurethral resection of the prostate ( TUR-P ) or transurethral resection of the urinary bladder ( TUR-M ) .


Patients scheduled to undergo TUR-P or TUR-M were randomized to receive either 3 ml ( 15 mg ) 0.5 % isobaric levobupivacaine ( group L ) or 3 ml ( 15 mg ) of 0.5 % hyperbaric bupivacaine ( group B ) for spinal anaesthesia .


The onset time , maximum level and time to reach the maximum level of sensory and motor blockade were recorded .


Changes to haemodynamic parameters were also recorded .


The study randomized 100 patients : 57 to group L and 43 to group B. Levobupivacaine did not cause any significant changes in haemodynamic parameters , including systolic blood pressure , and showed a similar sensory block onset time compared with bupivacaine , but it had a significantly longer motor block onset time compared with bupivacaine .


These current findings suggest that levobupivacaine can be used as a substitute for bupivacaine for spinal anaesthesia in elderly patients 65 years of age undergoing elective TUR-P or TUR-M operations .


Breast reconstruction aims to improve health-related quality of life after mastectomy .


However , evidence guiding patients and surgeons in shared decision-making concerning the optimal type or timing of surgery is lacking .


QUEST comprised two parallel feasibility phase III randomized multicentre trials to assess the impact of the type and timing of latissimus dorsi breast reconstruction on health-related quality of life when postmastectomy radiotherapy is unlikely ( QUEST A ) or highly probable ( QUEST B ) .


The primary endpoint for the feasibility phase was the proportion of women who accepted randomization , and it would be considered feasible if patient acceptability rates exceeded 25 per cent of women approached .


A companion QUEST Perspectives Study ( QPS ) of patients ( both accepting and declining trial participation ) and healthcare professionals assessed trial acceptability .


The QUEST trials opened in 15 UK centres .


After 18 months of recruitment , 17 patients were randomized to QUEST A and eight to QUEST B , with overall acceptance rates of 19 per cent ( 17 of 88 ) and 22 per cent ( 8 of 36 ) respectively .


The QPS recruited 56 patients and 51 healthcare professionals .


Patient preference was the predominant reason for declining trial entry , given by 47 ( 53 per cent ) of the 88 patients approached for QUEST A and 22 ( 61 per cent ) of the 36 approached for QUEST B. Both trials closed to recruitment in December 2012 , acknowledging the challenges of achieving satisfactory patient accrual .


Despite extensive efforts to overcome recruitment barriers , it was not feasible to reach timely recruitment targets within a feasibility study .


Patient preferences for breast reconstruction types and timings were common , rendering patients unwilling to enter the trial .


The depressor septi nasi muscle is responsible for smiling deformity .


Its manipulation is beneficial in patients with muscle hypertrophy .


In addition , it enhances the smile and tip-lip relationship .


In this study , depressor septi nasi muscle excision through a transfixion incision is compared with its transposition through an upper labial sulcus incision .


Two techniques of depressor septi nasi muscle treatment were performed randomly for rhinoplasty cases .


Smile analysis in rhinoplasty , consisting of measurements of nasal length , nasal diagonal , tip projection , and upper lip height , and noting transverse upper labial crease in repose and full smile , was performed on preoperative and postoperative photographs .


One hundred patients were studied in two equal groups .


Preoperatively , tip projection and upper lip height were decreased significantly with smiling .


Generally , the effect of smiling on all five parameters was decreased significantly following rhinoplasty .


The two different techniques were not significantly different in decreasing the effects of smiling on nasal length , nasal diagonal , tip projection , upper lip height , or transverse crease .


The two different techniques were the same in decreasing the effects of smiling .


The authors recommend smile analysis in rhinoplasty , consisting of measurement of nasal length , nasal diagonal , tip projection , and upper lip height , and noting transverse upper labial crease in repose and during smiling , before rhinoplasty for preoperative evaluation and after the operation for outcome assessment .


Depressor septi nasi muscle treatment should be considered if a decrease in tip projection or upper lip height with smiling or a transverse upper labial crease during smiling is extraordinary or unsightly .


Therapeutic , II .


Somatosensory stimulation ( SS ) is a potential adjuvant to stroke rehabilitation , but the effect on function needs further investigation .


To explore the effect of combining SS with task-specific training ( TST ) on upper limb function and arm use in chronic stroke survivors and determine underlying mechanisms .


In this double-blinded randomized controlled trial ( ISRCTN 05542931 ) , 33 patients ( mean 37.7 months poststroke ) were block randomized to 2 groups : active or sham SS .


They received 12 sessions of 2 hours of SS ( active or sham ) to all 3 upper limb nerves immediately before 30 minutes of TST .


The primary outcome was the Action Research Arm Test ( ARAT ) score .


Secondary outcomes were time to perform the ARAT , Fugl-Meyer Assessment score ( FM ) , Motor Activity Log ( MAL ) , and Goal Attainment Scale ( GAS ) .


Underlying mechanisms were explored using transcranial magnetic stimulation stimulus-response curves and intracortical inhibition .


Outcomes were assessed at baseline , immediately following the intervention ( mean 2 days ) , and 3 and 6 months ( mean 96 and 190 days ) after the intervention .


The active group ( n = 16 ) demonstrated greater improvement in ARAT score and time immediately postintervention ( between-group difference ; P < .05 ) , but not at 3 - or 6-month follow-ups ( P > .2 ) .


Within-group improvements were seen for both groups for ARAT and GAS , but for the active group only for FM and MAL ( P < .05 ) .


Corticospinal excitability did not change .


Long-lasting improvements in upper limb function were observed following TST .


Additional benefit of SS was seen immediately post treatment , but did not persist and the underlying mechanisms remain unclear .


There is current interest in the maternal-fetal effects of antenatal vitamin D supplementation , yet little data regarding vitamin D 's role in neonatal calcium homeostasis .


We determined to assess the effect of high-dose antenatal vitamin D supplementation on fetal and neonatal calcium concentrations .


In a double-blinded , placebo-controlled trial in Bangladesh , 160 pregnant women were randomized to oral vitamin D3 ( 35,000 IU/wk ) or placebo from 26 to 29wk of gestation .


Total serum calcium ( Ca ) was higher in cord blood of those supplemented vs. placebo ( 2.660.1 vs. 2.610.2 mmol/l ; P = 0.04 ) , but the difference in albumin-adjusted calcium was not statistically significant .


Change in Ca concentration from birth to day 3 of life was attenuated by vitamin D ( -0.100.17 ) compared with placebo ( -0.220.18 mmol/l ; P = 0.02 ) .


Maternal 25-hydroxyvitamin D ( 25 ( OH ) D ) ( P = 0.04 ) and cord 25 ( OH ) D ( P < 0.01 ) were associated with day 3 infant Ca , suggesting that the effect of supplementation was mediated by change in maternal-infant vitamin D status .


Six infants in each of the supplemented and placebo groups had transient hypercalcemia/hypercalcuria ; in all the hypercalcemia/hypercalcuria was asymptomatic , spontaneously resolved , and unassociated with nephrocalcinosis at 1 mo of life .


High-dose antenatal third-trimester vitamin D supplementation attenuated the early postnatal calcium nadir , without increasing the risk of postnatal hypercalcemia .


Patients on chronic dialysis are at increased risk of vitamin D deficiency .


In observational studies plasma 25-hydroxyvitamin D ( p-25 ( OH ) D ) levels are inversely correlated with plasma BNP and adverse cardiovascular outcomes .


Whether a causal relation exists has yet to be established .


The aim of this study was to test the hypothesis that cholecalciferol supplementation improves cardiac function and reduces blood pressure ( BP ) and pulse wave velocity ( PWV ) in patients on chronic dialysis .


In a randomized , placebo-controlled , double-blind study , we investigated the effect of 75 g ( 3000 IU ) cholecalciferol daily for 6 months , in patients on chronic dialysis .


We performed two-dimensional echocardiography , with doppler and tissue-doppler imaging , 24-h ambulatory BP ( 24-h BP ) , PWV , augmentation index ( AIx ) , central BP ( cBP ) and brain natriuretic peptide ( BNP ) measurements at baseline and after 6 months .


Sixty-four patients were allocated to the study .


Fifty dialysis patients with a mean age of 68 years ( range : 46-88 ) and baseline p-25 ( OH ) D of 28 ( 20 ; 53 ) nmol/l completed the trial .


Cholecalciferol increased left ventricular ( LV ) volume , but had no impact on other parameters regarding LV structure or left atrial structure .


LV systolic function , LV diastolic function , PWV , cBP , AIx and BNP were not changed in placebo or cholecalciferol group at follow-up .


24-h BP decreased significantly in placebo group and tended to decrease in cholecalciferol group without any difference between treatments .


Six months of cholecalciferol treatment in patients on chronic dialysis did not improve 24-h BP , arterial stiffness or cardiac function .


NCT01312714 , Registration Date : March 9 , 2011 .


Excessive use of short-acting 2-agonists ( SABA ) indicates impaired asthma control .


To determine whether real-time outreach to excessive SABA users reduces SABA canister dispensings .


After real-time determination of a seventh SABA canister dispensing in the prior 12 months by using informational pharmacy technology , 12 to 56 year old patients with physician-coded asthma and inhaled corticosteroid dispensing were block randomized by prior asthma specialist care and medication step-care level into intervention ( n = 1001 ) and control groups ( n = 998 ) .


Intervention included real-time letter notification to patients and an electronic message to their physician with management suggestions , including facilitated allergy referral for patients without prior asthma specialist care .


The control group received this organization 's standard asthma care management without research contact .


Frequency of the seventh SABA canister dispensing in the follow-up year was the primary outcome .


Compared with controls , intervention patients reached 7 SABA canister dispensings less frequently ( 50.7 % vs 57.1 % ; risk ratio 0.89 [ 95 % CI , 0.82-0 .97 ] ; P = .007 ) and later ( hazard ratio 0.80 [ 95 % CI , 0.71-0 .91 ; P < .001 ) .


SABA canister dispensings ( mean SD ) were less in intervention ( 7.5 4.9 canisters ) than controls ( 8.6 5.3 canisters ) ( rate ratio 0.87 [ 95 % CI , 0.82-0 .93 ] ; P < .001 ) .


The intervention reduced the risk of 7 SABA canister dispensings in patients without specialist care compared with patients with specialist care in the prior 3 years ( P < .001 ) ( P = .04 for interaction by prior specialist care ) .


Visits to allergists were more frequent for intervention patients ( 30.9 % ) than for control patients ( 16.8 % ) ( risk ratio 1.83 [ 95 % CI , 1.54-2 .16 ] ; P < .001 ) .


Asthma exacerbations were unaffected .


A novel administrative-based asthma outreach program improves markers of asthma impairment in patients without prior asthma specialist care and is adaptable to managed care organizations with electronic medical records .


To minimize stent-related symptoms , the proximal part of the Polaris stent is composed of a firm material and its distal part is composed of a soft material .


The aim of this study was to compare stent-related symptoms of Polaris and Percuflex stents and to assess the impacts of these stents on quality of life .


A total of 144 patients were randomized to a `` test '' group ( Polaris ; n = 64 ) or a `` conventional '' group ( Percuflex ; n = 80 ) at the time of ureteral stent insertion after ureteroscopic stone removal surgery .


Stents were allocated using a randomization program .


At 1 week postoperatively , patient symptoms were evaluated using the Ureteral Stent Symptom Questionnaire ( USSQ ) , and patients were asked complete a 10cm visual analogue scale ( VAS ) .


Mean scores for USSQ domains and mean VAS scores were compared .


Mean patient age was 50.3 years , and the male-to-female ratio was 1:0.85 .


No significant intergroup differences were found in the domain scores of urinary symptoms ( P = 0.58 ) , pain ( P = 0.87 ) , general health ( P = 0.20 ) , work ( P = 0.24 ) , sexual activity ( P = 0.64 ) , or additional problems ( P = 0.24 ) .


In addition , VAS scores were nonsignificantly different ( P = 0.11 ) .


Analysis of USSQ item scores , however , revealed the test group had better results for `` presence of pain , '' `` frequency of pain killer use , '' `` difficulties with respect to hard physical activity , '' `` fatigue , '' `` frequency of rest , '' `` stent-related impact on work , '' `` antibiotics use '' than the conventional group except for `` outpatient department visits '' .


Compared with the conventional Percuflex ureteral stent , the new Polaris ureteral stent with a soft tail was not found to offer significant advantages in terms of voiding symptoms , pain , general health , sexual matters , or additional problems as determined by the USSQ or in VAS determined pain .


Sub-analysis , however , showed that the Polaris has some advantages with respect to pain , physical activities , impact on work , and additional problems .


Accordingly , the soft-tipped Polaris stent was found to have some clinical advantages over the conventional Percuflex stent .


To evaluate sexual function in midlife women taking low-dose oral estradiol or venlafaxine for hot flushes .


In an 8-week randomized controlled trial among women aged 40-62 years , sexual function was compared between 0.5 mg oral estradiol per day or 75 mg venlafaxine per day ( both compared with a placebo ) .


Measures included composite and six domain scores from the Female Sexual Function Index and sexually related personal distress .


Participants were aged 54.6 years ( standard deviation [ SD ] 3.8 ) years , 59 % white , with 8.1 ( SD 5.3 ) daily hot flushes .


Median composite baseline Female Sexual Function Index score was 16.3 ( SD 11.9 , n = 256 ) for all women and 21.7 ( SD 9.3 , n = 198 ) among sexually active women .


Composite mean Female Sexual Function Index change from baseline to week 8 was 1.4 ( 95 % confidence interval [ CI ] -0.4 to 3.2 ) for estradiol , 1.1 ( 95 % CI -0.5 to 2.7 ) for venlafaxine , and -0.3 ( 95 % CI -1.6 to 1.0 ) for placebo .


Composite Female Sexual Function Index and sexually related distress change from baseline did not differ between estradiol and placebo ( P = .38 , P = .30 ) or venlafaxine and placebo ( P = .79 , P = .48 ) .


Among sexually active women , Female Sexual Function Index domain score change from baseline differences ( active compared with placebo ) in desire was 0.3 ( 95 % CI 0.0-0 .6 ) for estradiol , -0.6 ( 95 % CI -1.2 to 0.0 ) in orgasm for venlafaxine , and 0.9 ( 95 % CI 0.2-1 .6 ) in penetration pain for venlafaxine .


No women reported adverse events related to sexual dysfunction .


Overall sexual function among nondepressed midlife women experiencing hot flushes did not change over 8 weeks with low-dose oral estradiol or venlafaxine ( compared with placebo ) , although a subtle increase in desire ( estradiol ) and decreases in orgasm and pain ( venlafaxine ) may exist .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT01418209 .


I.


Maternal depression carries a major public health burden for mothers and their infants , yet there is a substantial treatment gap for this condition in low-resourced regions such as sub-Saharan Africa .


To address this treatment gap , the strategy of `` task sharing '' has been proposed , involving the delivery of interventions by non-specialist health workers trained and supervised by specialists in routine healthcare delivery systems .


Several psychological interventions have shown benefit in treating maternal depression , but few have been rigorously evaluated using a task sharing approach .


The proposed trial will be the first randomised controlled trial ( RCT ) evaluating a task sharing model of delivering care for women with maternal depression in sub-Saharan Africa .


The objective of this RCT is to determine the effectiveness and cost-effectiveness of a task sharing counseling intervention for maternal depression in South Africa .


The study is an individual-level two-arm RCT .


A total of 420 depressed pregnant women will be recruited from two ante-natal clinics in a low-income township area of Cape Town , using the Edinburgh Postnatal Depression Scale to screen for depression ; 210 women will be randomly allocated to each of the intervention and control arms .


The intervention group will be given six sessions of basic counseling over a period of 3 to 4 months , provided by trained community health workers ( CHW ) s.


The control group will receive three monthly phone calls from a CHW trained to conduct phone calls but not basic counseling .


The primary outcome measure is the 17-Item Hamilton Depression Rating Scale ( HDRS-17 ) .


The outcome measures will be applied at the baseline assessment , and at three follow-up points : 1 month before delivery , and 3 and 12 months after delivery .


The primary analysis will be by intention-to-treat and secondary analyses will be on a per protocol population .


The primary outcome measure will be analyzed using linear regression adjusting for baseline symptom severity measured using the HDRS-17 .