The distinct improvement rate and improvement rate of symptom ( lower abdomen pain , low back pain ) scores during menstruation days at 12 weeks after the first injection , the rates of lower abdomen pain were 73.9 % ( 34/46 ) , 15.2 % ( 7/46 ) respectively in the test group , 72.3 % ( 34/47 ) , 2.1 % ( 1/47 ) respectively in the control group , had statistically significant difference between the two groups ( P = 0.026 ) .


There was no serious adverse event occurred in both two groups .


The incidence rate of adverse event was 33.6 % ( 38/113 ) in test group , 23.2 % ( 27/116 ) in control group , there was no significant difference between the two groups ( P = 0.082 ) .


Leuprolide acetate is effective and safe in the treatment of endometriosis .


To determine whether home-use icterometry improves parental recognition of neonatal jaundice , early care seeking and treatment to minimize risks of bilirubin encephalopathy .


Cluster-randomised controlled trial of community-level icterometry used at home by mothers in Chi Linh , Vietnam .


Rural health-care workers identified and enrolled term newborns .


Post-partum mothers received jaundice education and icterometry instructions and were cluster-randomised by commune .


Cases received icterometers ( icterometer group ( IG ) ) and controls did not ( control group ( CG ) ) .


Subjects received mobile telephone calls from post-natal days 2-7 to determine maternal recognition by visual inspection and icterometer detection of jaundice ( 3.0 on five-point scale ) .


Mothers without telephones , premature newborns ( < 35 weeks ) or newborns hospitalised > 5 days were excluded .


Three hundred fifty-two subjects were enrolled ( 183 IG and 169 CG ) , of whom 11 ( 3.4 % ) were lost to telephone follow-up .


Jaundice was recognised and/or detected in 94 ( 27 % ) of all newborns .


Icterometry helped 11 mothers ( 6 % ) detect neonatal jaundice that was not visually recognised by IG mothers .


Detection by IG mothers was not statistically greater than CG mothers ( P = 0.09 ) .


Follow-up care seeking was 8 % in both groups ( P = 0.2 ) , and 11 % of jaundiced newborns received treatment ( 9 % IG vs. 16 % CG , P = 0.3 ) .


Newborns who received care had bilirubin measurements that averaged 257 mol/L IG vs. 322 mol/L CG ( P = 0.3 ) .


There were no deaths .


In this pilot study , home-use icterometry may help improve parental detection of jaundice in rural Vietnam .


However , larger studies are necessary to determine the changes in recognition , care seeking and treatment .


In people with obesity hypoventilation syndrome ( OHS ) , breathing 100 % oxygen increases carbon dioxide ( PCO2 ) , but its effect on pH is unknown .


This study investigated the effects of moderate concentrations of supplemental oxygen on PCO2 , pH , minute ventilation ( VE ) and physiological dead space to tidal volume ratio ( VD/VT ) among people with stable untreated OHS , with comparison to healthy controls .


In a double-blind randomised crossover study , participants breathed oxygen concentrations ( FiO2 ) 0.28 and 0.50 , each for 20 min , separated by a 45 min washout period .


Arterialised-venous PCO2 ( PavCO2 ) and pH , VE and VD/VT were measured at baseline , then every 5 min .


Data were analysed using general linear model analysis .


28 participants were recruited ( 14 OHS , 14 controls ) .


Among OHS participants ( mean SD arterial PCO2 6.7 0.5 kPa ; arterial oxygen 8.9 1.4 kPa ) FiO2 0.28 and 0.50 maintained oxygen saturation 98-100 % .


After 20 min of FiO2 0.28 , PavCO2 change ( PavCO2 ) was 0.3 0.2 kPa ( p = 0.013 ) , with minimal change in VE and rises in VD/VT of 1 5 % ( p = 0.012 ) .


FiO2 0.50 increased PavCO2 by 0.5 0.4 kPa ( p = 0.012 ) , induced acidaemia and increased VD/VT by 3 3 % ( p = 0.012 ) .


VE fell by 1.2 2.1 L/min within 5 min then recovered individually to varying degrees .


A negative correlation between VE and PavCO2 ( r = -0.60 , p = 0.024 ) suggested that ventilatory responses were the key determinant of PavCO2 rises .


Among controls , FiO2 0.28 and 0.50 did not change PavCO2 or pH , but FiO2 0.50 significantly increased VE and VD/VT .


Commonly used oxygen concentrations caused hypoventilation , PavCO2 rises and acidaemia among people with stable OHS .


This highlights the potential dangers of this common intervention in this group .


Fish and meat intake may affect gestational weight gain , body composition and serum fatty acids .


We aimed to determine whether a longitudinal dietary intervention during pregnancy could increase fish intake , affect serum phospholipid fatty acids , gestational weight gain and body composition changes during pregnancy in women of normal weight participating in the Pregnancy Obesity Nutrition and Child Health study .


A second aim was to study possible effects in early pregnancy of fish intake and meat intake , respectively , on serum phospholipid fatty acids , gestational weight gain , and body composition changes during pregnancy .


In this prospective , randomized controlled study , women were allocated to a control group or to a dietary counseling group that focused on increasing fish intake .


Fat mass and fat-free mass were measured by air-displacement plethysmography .


Reported intake of fish and meat was collected from a baseline population and from a subgroup of women who participated in each trimester of their pregnancies .


Serum levels of phospholipid arachidonic acid ( s-ARA ) , eicosapentaenoic acid ( s-EPA ) , and docosahexaenoic acid ( s-DHA ) were measured during each trimester .


Weekly fish intake increased only in the intervention group ( n = 18 ) from the first to the second trimester ( median difference 113g , p = 0.03 ) and from the first to the third trimester ( median difference 75g , p = 0.01 ) .


In the first trimester , fish intake correlated with s-EPA ( r = 0.36 , p = 0.002 , n = 69 ) and s-DHA ( r = 0.34 , p = 0.005 , n = 69 ) , and meat intake correlated with s-ARA ( r = 0.28 , p = 0.02 , n = 69 ) .


Fat-free mass gain correlated with reported meat intake in the first trimester ( r = 0.39 , p = 0.01 , n = 45 ) .


Dietary counseling throughout pregnancy could help women increase their fish intake .


Intake of meat in early pregnancy may increase the gain in fat-free mass during pregnancy .


Physical inactivity is a significant risk factor for cardiovascular disease and remains highly prevalent in middle-aged women .


We hypothesized that an interventionist-led ( IL ) , primary-care-based physical activity ( PA ) and weight loss intervention would increase PA levels and decrease weight to a greater degree than a self-guided ( SG ) program .


We conducted a randomized trial .


Ninety-nine inactive women aged 45-65 years and with BMI 25 kg/m ( 2 ) were recruited from three primary care clinics .


The interventionist-led ( IL ) group ( n = 49 ) had 12 weekly sessions of 30 min discussions with 30 min of moderate-intensity PA. .


The self-guided ( SG ) group ( n = 50 ) received a manual for independent use .


Assessments were conducted at 0 , 3 , and 12 months ; PA and weight were primary outcomes .


Weight was measured with a standardized protocol .


Leisure PA levels were assessed using the Modifiable Activity Questionnaire .


Differences in changes by group were analyzed with a t-test or Wilcoxon rank-sum test .


Mixed models were used to analyze differences in changes of outcomes by group , using an intention-to-treat principle .


Data from 98 women were available for analysis .


At baseline , mean ( SD ) age was 53.9 ( 5.4 ) years and 37 % were black .


Mean weight was 92.3 ( 17.7 ) kg and mean BMI was 34.7 ( 5.9 ) kg/m ( 2 ) .


Median PA level was 2.8 metabolic equivalent hours per week ( MET-hour/week ) ( IQR 0.0 , 12.0 ) .


At 3 months , IL women had a significantly greater increase in PA levels ( 7.5 vs. 1.9 MET-hour/week ; p = 0.02 ) than SG women ; there was no significant difference in weight change .


At 12 months , the difference between groups was no longer significant ( 4.7 vs. 0.7 MET-hour/week ; p = 0.38 ) .


Mixed model analysis showed a significant ( p = 0.048 ) difference in PA change between groups at 3 months only .


The IL intervention was successful in increasing the physical activity levels of obese , inactive middle-aged women in the short-term .


No significant changes in weight were observed .


To determine the intravitreal anti-vascular endothelial growth factor ( VEGF ) injection techniques and preferences within the retinal community and to identify potential factors associated with the development of sustained intraocular pressure ( IOP ) elevation in patients treated with intravitreal anti-VEGF therapy for neovascular age-related macular degeneration ( AMD ) .


Cross-sectional physician survey .


Five hundred and thirty retina specialists spanning both private and academic practices were surveyed regarding current anti-VEGF intravitreal injection protocols , including the anti-VEGF drug of choice , needle gauge , injection volume , injection technique , and self-reported prevalence of sustained IOP elevation .


Multivariate logistic regressions were performed to assess the potential influence of these factors on long-term IOP .


Two hundred ninety-two specialists ( 55 % ) reported believing that intravitreal anti-VEGF therapy may cause sustained IOP elevation .


Of these responses , the most common reported prevalence was 1 % -2 % ( 48 % ) , followed by 3 % -5 % ( 34 % ) .


There was no relationship between the frequency of sustained IOP elevation and anti-VEGF drug of choice .


Physicians who injected greater than 0.05 cc in less than 1 second were 5.56 times more likely to observe a high frequency of sustained IOP elevation ( P = .006 , 95 % CI 1.64-18 .89 ) .


Based on physician survey data , serial anti-VEGF injections using higher injection volumes with a rapid injection technique may potentially lead to sustained IOP elevation .


The underlying mechanism for this complication may be injury to the trabecular meshwork resulting from rapid elevations in IOP .


Further investigation of the relationship between injection techniques and sustained IOP elevation in the form of retrospective or prospective clinical studies is warranted .


Purified palmitoleic acid ( 16-1 ; omega-7 ) has shown lipid-lowering and anti-inflammatory benefits in open label , epidemiologic , and animal studies .


Our objective was to perform the first randomized controlled trial of purified palmitoleic acid supplementation in humans .


Adults with dyslipidemia and evidence of mild systemic inflammation ( high-sensitivity C-reactive protein [ hs-CRP ] between 2 and 5mg/L ) were randomly allocated to receive either 220.5 mg of cis-palmitoleic acid ( n = 30 ) or an identical capsule with placebo ( 1000mg of medium chain triglycerides , n = 30 ) once per day for 30days .


Participants were asked to maintain their current diet .


Serum lipids and hs-CRP were drawn at baseline and study completion .


At 30days , there were significant mean ( 95 % confidence interval [ CI ] ) reductions in CRP ( -1.9 [ -2.3 to -1.4 ] mg/L ) , triglyceride ( -30.2 [ -40.2 to -25.3 ] mg/dL ) , and low-density lipoprotein ( LDL ) ( -8.9 [ -12.0 to -5.8 ] mg/dL ) , and a significant increase in high-density lipoprotein ( HDL ) ( 2.4 [ 1.5 , 3.3 ] mg/dL ) in the intervention group compared with control .


These changes equated to 44 % , 15 % , and 8 % reductions in CRP , triglyceride , and LDL respectively , and a 5 % increase in HDL compared with control .


Purified palmitoleic acid may be useful in the treatment of hypertriglyceridemia with the beneficial added effects of decreasing LDL and hs-CRP and raising HDL .


Further study is needed to elucidate mechanisms and establish appropriate human doses .


This double-blind , crossover study evaluated whole plaque fluoride concentration ( F ) , as well as whole plaque calcium concentrations ( Ca ) after brushing with a placebo ( PD - fluoride free ) , low-fluoride ( LFD , 513 microg F/g ) and conventional ( CD , 1,072 microg F/g ) dentifrices .


Children ( n = 20 ) were randomly assigned to brush twice daily with one of the dentifrices , during 7 days .


On the 7th day , samples were collected at 1 and 12 hours after brushing .


F and Ca were analyzed with an ion-selective electrode and with the Arsenazo III method , respectively .


Data were analyzed by ANOVA , Tukey 's test and by Pearson correlation coefficient ( P < 0.05 ) .


The use of the fluoridated dentifrices significantly increased plaque [ F ] s 1 hour after brushing when compared to PD , returning to baseline levels 12 hours after .


Positive and significant correlations were found between plaque [ F ] and ( Ca ) under most of the conditions evaluated .


The mean increase in plaque [ F ] observed 1 hour after brushing with the CD were only about 47 % higher than those obtained for the LFD .


The use of a LFD promotes proportionally higher increases in plaque [ F ] when compared to a CD .


Plaque F concentrations were also shown to be dependent on plaque Ca concentrations .


Transcutaneous electrical nerve stimulation ( TENS ) is a useful modality for pain control .


TENS has recently been applied to decrease spasticity .


The purpose of this study is to determine whether the addition of TENS to an exercise program reduces spasticity and improves balance and gait in chronic stroke patients .


This was a single-blinded , multicenter , randomized controlled trial .


Thirty-four ambulatory individuals with chronic stroke participated and were randomly allocated to the TENS or Placebo group .


The TENS group performed therapeutic exercise with TENS while the placebo ( non-stimulation ) TENS group performed therapeutic exercise with placebo TENS .


Participants in both groups followed the same 30-min exercise regimen 5 times per week for a period of 6 weeks .


Spasticity ( modified Ashworth scale ) , static ( balance system ) , and dynamic balance ( timed up and go test ) , and gait ability ( gait analyzer ) were measured at 1 week before and 1 week after the intervention .


Significant differences were observed between the 2 groups .


Spasticity improved by 0.80 points in the TENS group .


Anterior-posterior and medial-lateral sway velocity among static balance parameters and dynamic balance showed significant differences between the TENS and Placebo TENS groups ( p = .000 ) .


Gait speed and cadence were enhanced significantly in the TENS group ( p = .000 ) .


Step and stride length on the paretic side showed a significant difference in the TENS group ( p = .000 ) , while only velocity showed a significant difference in the Placebo TENS group ( p = .004 ) .


A combination of therapeutic exercise and TENS may reduce spasticity and improve balance , gait , and functional activity in chronic stroke patients .


Tight blood glucose control has become a therapeutical goal for anesthetic management for patients scheduled for cardiac surgery , especially if they are diabetic patients .


This study was created to confirm the benefits of intraoperative GIK solution usage during coronary bypass operation of diabetic patients .


Patients with type 1 and 2 diabetes mellitus ( DM ) referred for coronary artery bypass grafting ( CABG ) were randomized to receive GIK solution ( GIK -- study group ) in the first 24 hours intraoperatively or to receive official Clinical protocol without GIK solution ( non GIK - control group ) .


The primary clinical outcome was the cardiac index ( CI ) since it represents the most sensitive measure of cardiac work in the immediate postoperative period , and the secondary clinical outcomes were the glycemic control , insulin consumption , duration of mechanical ventilation ( MV ) , potassium level and atrial fibrillation ( AF ) appearance .


One hundred diabetic patients , divided into two groups , were included in the study .


The cardiac index did not show a significant difference , although the study group had CI with only minor variations than those of the controlled group , hence the reason we considered the study group as the more stable .


The atrial fibrillation showed a difference between two groups , with 14 ( 28 % ) patients with postoperative AF in the control group compared with 3 ( 6 % ) patients with postoperative AF in the study group .


As potassium values were stable in study group , we concluded that it can be one of the reasons for less postoperative AF in this group .


The duration of MV showed a significant difference ( 0,003 ) between the two groups as well .


In the study group the average MV time was 534,38 minutes , compared with the control group with 749,20 minutes .


The average value of glucose was 11.1 mmol/l in the control group vs. 9.8 mmol/l in the study group .


The study group had less insulin consumption in order to maintain target glycemia ( p = 0.001 ) .


In the non GIK group average insulin consumption was 44 IJ per patient vs. 28.5 IJ in the GIK group .


Intraoperative GIK solution given to diabetic patients with CABG operation provides more stable CI , shorter time of MV , more stable values of potassium which provides normal rhythm and less AF onset , less insulin to maintain target glycemia .


All the above mentioned provides more stable intraoperative hemodynamic and better recovery of diabetic


High-intensity noninvasive ventilation ( HI-NIV ) is the most effective means of improving several physiological and clinical parameters in subjects with chronic hypercapnic COPD .


Whether the newer hybrid mode using target tidal volume noninvasive ventilation ( target V ( T ) NIV ) provides additional benefits remains unclear .


Subjects with COPD successfully established on long-term HI-NIV were switched to target V ( T ) NIV .


Optimal target V ( T ) settings according to nocturnal transcutaneous P ( CO2 ) measurements were achieved following a randomized crossover trial using 8 mL/kg ideal body weight and 110 % of individual V ( T ) during HI-NIV , respectively .


The following parameters were compared at the beginning of the trial while subjects were on HI-NIV , and after 3 months on optimal target V ( T ) NIV : sleep quality by polysomnography , overnight gas exchange , subjects ' tolerance , overnight pneumotachygraphic measurements during NIV , health-related quality of life ( severe respiratory insufficiency questionnaire ) , exercise capacity ( 6-min walk test ) , and lung function .


Ten of 14 subjects completed the study .


There were no differences between HI-NIV and target V ( T ) NIV in any of the above-mentioned parameters .


Specifically , the mean overnight transcutaneous P ( CO2 ) was equivalent under each form of ventilation ( both 45 5 mm Hg , P = .75 ) .


Switching subjects from well-established HI-NIV to target V ( T ) NIV shows no clinical benefits in chronic hypercapnic COPD .


In particular , sleep quality , the control of nocturnal hypoventilation , daytime hypercapnia , overnight ventilation patterns , subjects ' tolerance , health-related quality of life , lung function , and exercise capability were all similar in subjects who underwent HI-NIV and target V ( T ) NIV .


Nevertheless , target V ( T ) NIV might offer some physiological advantages in breathing pattern and might be beneficial in some individual patients .


( German Clinical Trials Register [ www.drks.de ] Registration DRKS00000450 . )


Patients with cirrhosis and variceal hemorrhage have a high risk of rebleeding .


We performed a prospective randomized trial to compare the prevention of rebleeding in patients given a small-diameter covered stent vs those given hepatic venous pressure gradient ( HVPG ) - based medical therapy prophylaxis .


We performed an open-label study of patients with cirrhosis ( 92 % Child class A or B , 70 % alcoholic ) treated at 10 medical centers in Germany .


Patients were assigned randomly more than 5 days after variceal hemorrhage to groups given a small covered transjugular intrahepatic portosystemic stent-shunt ( TIPS ) ( 8 mm ; n = 90 ) , or medical reduction of portal pressure ( propranolol and isosorbide-5-mononitrate ; n = 95 ) .


HVPG was determined at the time patients were assigned to groups ( baseline ) and 2 weeks later .


In the medical group , patients with an adequate reduction in HVPG ( responders ) remained on the drugs whereas nonresponders underwent only variceal band ligation .


The study was closed 10 months after the last patient was assigned to a group .


The primary end point was variceal rebleeding .


Survival , safety ( adverse events ) , and quality of life ( based on the Short Form-36 health survey ) were secondary outcome measures .


A significantly smaller proportion of patients in the TIPS group had rebleeding within 2 years ( 7 % ) than in the medical group ( 26 % ) ( P = .002 ) .


A slightly higher proportion of patients in the TIPS group experienced adverse events , including encephalopathy ( 18 % vs 8 % for medical treatment ; P = .05 ) .


Rebleeding occurred in 6 of 23 patients ( 26 % ) receiving medical treatment before hemodynamic control was possible .


Per-protocol analysis showed that rebleeding occurred in a smaller proportion of the 32 responders ( 18 % ) than in nonresponders who received variceal band ligation ( 31 % ) ( P = .06 ) .


Fifteen patients from the medical group ( 16 % ) underwent TIPS placement during follow-up evaluation , mainly for refractory ascites .


Survival time and quality of life did not differ between both randomized groups .


Placement of a small-diameter , covered TIPS was straightforward and prevented variceal rebleeding in patients with Child A or B cirrhosis more effectively than drugs , which often required step-by-step therapy .


However , TIPS did not increase survival time or quality of life and produced slightly more adverse events .


Clinical Trial no : ISRCTN 16334693 .


To assess the effects of daily consumption of a synbiotic yogurt drink on the health , growth , and quality of life of healthy children 12-48 months of age in out-of-home child care .


Healthy children attending child care centers were enrolled in a prospective , double-blind , placebo-controlled clinical trial .


The intervention was a yogurt drink containing Streptococcus thermophilus , Lactobacillus bulgaricus , and Bifidobacterium animalis subspecies lactis ( BB-12 ) ( 5 10 ( 9 ) cfu/100 mL serving ) , and 1 g of inulin ( synbiotic group ) vs a similar nonsynbiotic-containing acidified milk drink ( placebo group ) once daily for 16 weeks .


The end points were days of diarrhea , fever , vomiting , symptoms of upper respiratory tract infection , use of antibiotics , physician visits , child care absenteeism , parental work absenteeism , and quality of life ( PedsQL 4.0 ; Mapi Research Trust , Lyon , France ) .


Compared with placebo ( n = 73 ) , children receiving synbiotic ( n = 76 ) had significantly fewer days of reported fever ( 1.85 vs 1.95 , P < .05 ) , significant improvement in social functioning ( P < .035 ; pre-to-end intervention ) , and school functioning ( P < .045 ; pre-to-mid intervention ) .


More days with 3 loose/watery stools were reported in the synbiotic group ( P < .05 ) .


Daily supplementation of children 's diet with yogurt containing probiotic bacteria BB-12 and inulin significantly reduced days of fever and improved social and school functioning .


The increased frequency of bowel movements may be explained by an accelerating effect of BB-12 and inulin on intestinal transit .


Further research on the possible benefits of synbiotics on children 's health is advised .


ClinicalTrials.gov : NCT00653705 .


In older adults with anxiety disorders , chronically elevated cortisol may contribute to cognitive impairment and elevated anxiety .


We conducted a pilot study with mifepristone , a glucocorticoid receptor antagonist , as a potential treatment for late-life anxiety disorders and co-occurring cognitive dysfunction .


Fifteen individuals 60years and older with an anxiety disorder plus cognitive dysfunction participated in the 12-week study .


In the first week , participants were randomly assigned to mifepristone 300mg daily or placebo .


In the subsequent 3weeks , all participants received mifepristone 300mg .


Mifepristone was then discontinued , and the participants were reassessed 8weeks later .


We examined the following : ( 1 ) cognitive changes ; ( 2 ) worry symptom severity ; ( 3 ) safety and tolerability ; and ( 4 ) salivary cortisol before , during , and after mifepristone exposure .


Overall safety , tolerability , and high retention supported the feasibility of this research .


Participants with higher baseline cortisol levels ( peak cortisol > 6.0 ng/ml , n = 5 ) showed improvements in memory , executive function , and worry severity after 3-4weeks of mifepristone with persistent memory and worry improvements 8weeks after mifepristone discontinuation .


Individuals with low-to-normal baseline cortisol ( n = 8 ) showed little to no improvement .


As expected , cortisol levels rose during mifepristone exposure and returned to pretreatment levels 8weeks after mifepristone discontinuation .


In the first week of treatment , there were no differences between placebo-treated and mifepristone-treated participants .


The results of this pilot study warrant further testing of antiglucocorticoid agents in late-life anxiety disorders with co-occurring cognitive dysfunction .


Mifepristone is hypothesized to have benefits in patients with evidence of glucocorticoid excess .


Directions for further study are discussed .


Low physical activity is a major risk factor for several age-related diseases .


Recently , we showed in a randomized controlled trial that a 12-week Web-based intervention ( Philips DirectLife ) to increase physical activity was effective in increasing physical activity levels and metabolic health in an inactive population aged 60-70 years .


The goal of this paper was to assess how many participants successfully reached the physical activity level as targeted by the intervention and what the effects of the intervention on body composition and metabolic health in these successful individuals were to provide insight in the maximum attainable effect of the intervention .


Among the 235 participants in a randomized controlled trial of the Actief en Gezond Oud ( AGO ) study , we assessed the effects of the intervention on metabolic parameters in those who had successfully reached their personalized physical activity target compared with the entire intervention group .


Furthermore , we studied the dose-response effect of increase in physical activity on metabolic outcome within the intervention group .


Of the intervention group , 50 of 119 ( 42.0 % ) participants successfully reached the physical activity target ( corresponding to a 10 % increased daily physical activity on average ) .


This group showed markedly higher effects of the intervention compared to the entire intervention group , with greater decreases in body weight ( 2.74 vs 1.49 kg ) , waist circumference ( 3.74 vs 2.33 cm ) , insulin resistance ( HOMA index : 0.23 vs 0.20 ) , and in cholesterol/HDL ratio ( 0.39 vs 0.20 ) and Framingham risk score ( 0.90 % vs 0.54 % ) .


We found that men compared to women were more likely to be successful .


The dose-response analysis showed that there was a significant association between increase in minutes spent in moderate-to-vigorous activity and body weight loss , BMI reduction , waist circumference reduction , HDL cholesterol increasing , and cholesterol/HDL ratio lowering .


Of the intervention group , 42.0 % ( 50/119 ) reached their daily physical activity end goal , which was associated with a markedly better effect on body composition and metabolic health compared to the effect in the entire intervention group .


In this population , men are more likely to be successful in increasing physical activity .


Findings demonstrate that improving the effect of such physical activity interventions requires finding new ways to increase the proportion of the population reaching the targeted goal .


Dutch Trial Registry : NTR 3045 ; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=3045 ( Archived by WebCite at http://www.webcitation.org/6KPw52dCc ) .


The aim of this clinical study was to determine the efficacy of Uncaria tomentosa ( cat 's claw ) against denture stomatitis ( DS ) .


Fifty patients with DS were randomly assigned into 3 groups to receive 2 % miconazole , placebo , or 2 % U tomentosa gel .


DS level was recorded immediately , after 1 week of treatment , and 1 week after treatment .


The clinical effectiveness of each treatment was measured using Newton 's criteria .


Mycologic samples from palatal mucosa and prosthesis were obtained to determinate colony forming units per milliliter ( CFU/mL ) and fungal identification at each evaluation period .


Candida species were identified with HiCrome Candida and API 20C AUX biochemical test .


DS severity decreased in all groups ( P < .05 ) .


A significant reduction in number of CFU/mL after 1 week ( P < .05 ) was observed for all groups and remained after 14 days ( P > .05 ) .


C albicans was the most prevalent microorganism before treatment , followed by C tropicalis , C glabrata , and C krusei , regardless of the group and time evaluated .


U tomentosa gel had the same effect as 2 % miconazole gel .


U tomentosa gel is an effective topical adjuvant treatment for denture stomatitis .


To explore whether cataract surgery contributes to the progression of wet age-related macular degeneration ( wet AMD ) .


Retrospective cohort study .


Retrospective review was performed of consecutive patients with wet AMD who underwent cataract surgery at the midpoint of a 1-year study window .


A control arm included wet AMD eyes treated with anti-vascular endothelial growth factor ( VEGF ) injections that did not undergo cataract surgery for a 1-year period .


Best-corrected visual acuity ( BCVA ) , number of anti-VEGF injections , and optical coherence tomography ( OCT ) features were compared between the 2 arms .


Forty eyes in the surgical group and 42 in the nonsurgical group were included .


BCVA was equivalent in the first half of the study , and became significantly better in the surgical group vs the nonsurgical group ( 0.23 0.65 vs 0.11 0.59 logMAR improvement , P = .049 ) .


There was no change in the number of injections given 6months before vs after the midpoint in the surgical group ( P = .921 ) .


The mean OCT central retinal thickness became greater in postsurgical eyes compared to nonsurgical eyes ( 265.4 98.4 m vs 216.4 58.3 m , P = .011 ) .


Surgical eyes were more likely to develop new or worse cystoid changes after the study midpoint ( 13 surgical eyes [ 54.2 % ] vs 9 nonsurgical eyes [ 28.1 % ] , P = .048 ) .


Cataract surgery leads to vision improvement and does not appear to contribute to worsening of wet AMD .


However , anatomic changes based on OCT analysis suggest a subclinical susceptibility to postoperative cystoid macular edema or exacerbation of choroidal neovascularization .


To assess the efficacy and safety of Reduning injection for fever , rash , and ulcers in children with mild hand , foot , and mouth disease ( HFMD ) .


A stratified-block randomized , double-blind , parallel-controlled , and multicenter clinical trial was conducted with 360 patients in five hospitals across China : Quanzhou Children 's Hospital , Shijiazhuang No. 5 Hospital , Shanghai Public Health Centre , Hunan Provincial Children 's Hospital , and Kaifeng Children 's Hospital .


Patients were randomized into three groups with 120 in each .


Group A was treated with Western Medicine , group B with Reduning injection , a Chinese herbal medicine , and group C with both Reduning injection and Western Medicine .


Results were compared for treatment efficacy and safety on HFMD .


The clinical outcomes were observed as follows : fever and onset time of antifebrile effect ( time to bring the body temperature down > or = 0.5 degrees C after medication ) ; cumulative time for fever recovery ( body temperature recovering to normal and lasting more than 24 h without medication ) ; cumulative time for rash disappearance ( without new rashes or ulcers appearing and the original ones fading away ) ; and cumulative time for mouth ulcer disappearance .


For the onset time of the antifebrile effect , there was no statistical difference between groups A and B ( P > 0.05 ) and groups B and C ( P > 0.05 ) .


However , there was a statistical difference between groups A and C ( P < 0.05 ) , and the effect in group C was the best .


For the cumulative time for rash disappearance , there was no statistical difference between groups A and B ( P > 0.05 ) .


There were statistical differences between groups A and C , and groups B and C ( P < 0.05 ) , and the effect in group C was the best .


For the cumulative time for mouth ulcers disappearance , there were no statistical differences among the three groups ( P > 0.05 ) .


Reduning injection with Western Medicine for symptomatic treatment is most effective for mild HFMD .


No adverse reactions were observed .


Oral feedback from clinical educators is the traditional teaching method for improving clinical consultation skills in medical students .


New approaches are needed to enhance this teaching model .


Multisource feedback is a commonly used assessment method for learning among practising clinicians , but this assessment has not been explored rigorously in medical student education .


This study seeks to evaluate if additional feedback on patient satisfaction improves medical student performance .


The Patient Teaching Associate ( PTA ) Feedback Study is a single site randomized controlled , double-blinded trial with two parallel groups.An after-hours general practitioner clinic in Victoria , Australia , is adapted as a teaching clinic during the day .


Medical students from two universities in their first clinical year participate in six simulated clinical consultations with ambulatory patient volunteers living with chronic illness .


Eligible students will be randomized in equal proportions to receive patient satisfaction score feedback with the usual multisource feedback and the usual multisource feedback alone as control .


Block randomization will be performed .


We will assess patient satisfaction and consultation performance outcomes at baseline and after one semester and will compare any change in mean scores at the last session from that at baseline .


We will model data using regression analysis to determine any differences between intervention and control groups .


Full ethical approval has been obtained for the study .


This trial will comply with CONSORT guidelines and we will disseminate data at conferences and in peer-reviewed journals .


This is the first proposed trial to determine whether consumer feedback enhances the use of multisource feedback in medical student education , and to assess the value of multisource feedback in teaching and learning about the management of ambulatory patients living with chronic conditions .


Australian New Zealand Clinical Trials Registry ( ANZCTR ) : ACTRN12613001055796 .


Genetic information given to an individual newly diagnosed with a genetic condition is likely to have important health implications for other family members .


The task of communicating with these relatives commonly falls to the newly diagnosed person .


Talking to relatives about genetic information can be challenging and is influenced by many factors including family dynamics .


Research shows that many relatives remain unaware of relevant genetic information and the possible impact on their own health .


This study aims to evaluate whether a specific genetic counselling intervention for people newly diagnosed with a genetic condition , implemented over the telephone on a number of occasions , could increase the number of at-risk relatives who make contact with genetics services after a new genetic diagnosis within a family .


This is a prospective , multi-centre randomised controlled trial being conducted at genetics clinics at five public hospitals in Victoria , Australia .


A complex genetic counselling intervention has been developed specifically for this trial .


Probands ( the first person in a family to present with a diagnosis of a genetic condition ) are being recruited and randomised into one of two arms - the telephone genetic counselling intervention arm and the control arm receiving usual care .


The number of at-risk relatives for each proband will be estimated from a family pedigree collected at the time of diagnosis .


The primary outcome will be measured by comparing the proportion of at-risk relatives in each arm of the trial who make subsequent contact with genetics services .


This study , the first randomised controlled trial of a complex genetic counselling intervention to enhance family communication , will provide evidence about how best to assist probands to communicate important new genetic information to their at-risk relatives .


This will inform genetic counselling practice in the context of future genomic testing .


Australia and New Zealand Clinical Trials Register ( ANZCTR ) : ANZCTRN12608000642381 .


To evaluate the efficacy of device-guided slow-paced respiration for reducing the frequency and severity of menopausal hot flushes .


Perimenopausal or postmenopausal women reporting four or more hot flushes per day were recruited into a parallel-group , randomized trial of slow-paced respiration using a portable guided-breathing device .


Women were randomly assigned to use a standard device to practice slowing their resting breathing rate to less than 10 breaths per minute for at least 15 minutes everyday or use an identical-appearing control device programmed to play relaxing nonrhythmic music while monitoring spontaneous breathing .


The primary outcome , change in hot flush frequency over 12 weeks , was assessed using data from validated 7-day diaries abstracted by blinded analysts .


Among the 123 participants , mean age was 53.4 ( 3.4 ) years .


Women reported an average of 8.5 ( 3.5 ) hot flushes per day at baseline .


After 12 weeks , women randomized to paced respiration ( n = 61 ) reported an average reduction of 1.8 ( 95 % confidence interval [ CI ] 0.9-2 .6 ) hot flushes per day ( -21 % ) compared with 3.0 ( 95 % CI 2.1-3 .8 ) hot flushes per day ( -35 % ) in the music-listening group ( n = 62 ) ( P = .048 ) .


Paced respiration was associated with a 19 % decrease in frequency of moderate-to-severe hot flushes compared with a 44 % decrease with music listening ( P = .02 ) .


In this randomized trial , women assigned to device-guided slow-paced respiration reported modest improvements in the frequency and severity of their hot flushes , but the paced respiration intervention was significantly less effective than a music-listening intervention in decreasing the frequency and severity of these symptoms .


I.


This analysis investigates incidence and time course of rash in the EURTAC study .


Patients with EGFR mutation-positive non-small-cell lung cancer were randomized 1:1 to receive once daily erlotinib or 3-weekly cycles of chemotherapy .


Of the 86 erlotinib-treated patients , 71 reported rash .


Median time to first rash appearance was 0.7 months .


Most patients ( n = 65 ) had the same or lower grade rash at final assessment compared with initial assessment .


Of the 21 patients with decreased rash grade between initial and final assessments , 61.9 % received no erlotinib dose modification , 42.8 % had no concomitant rash treatment .


Most rash cases were mild , occurred within 1 month of erlotinib treatment , and rapidly improved without the need for erlotinib dose alterations .


Gene expression profiling test scores have primarily been used to identify heart transplant recipients who have a low probability of rejection at the time of surveillance testing .


We hypothesized that the variability of gene expression profiling test scores within a patient may predict risk of future events of allograft dysfunction or death .


Patients from the IMAGE study with rejection surveillance gene expression profiling tests performed at 1 - to 6-month intervals were selected for this cohort study .


Gene expression profiling score variability was defined as the standard deviation of an individual 's cumulative test scores .


Gene expression profiling ordinal score ( range , 0-39 ) , threshold score ( binary value = 1 if ordinal score 34 ) , and score variability were studied in multivariate Cox regression models to predict future clinical events .


Race , age at time of transplantation , and time posttransplantation were significantly associated with future events in the univariate analysis .


In the multivariate analyses , gene expression profiling score variability , but not ordinal scores or scores over threshold , was independently associated with future clinical events .


The regression coefficient P values were < 0.001 , 0.46 , and 0.773 , for gene expression profiling variability , ordinal , and threshold scores , respectively .


The hazard ratio for a 1 unit increase in variability was 1.76 ( 95 % CI , 1.4-2 .3 ) .


The variability of a heart recipient 's gene expression profiling test scores over time may provide prognostic utility .


This information is independent of the probability of acute cellular rejection at the time of testing that is rendered from a single ordinal gene-expression profiling test score .


Musculoskeletal symptoms are the most common adverse effects of aromatase inhibitors ( AIs ) and can result in decreased quality of life and discontinuation of therapy .


Omega-3 fatty acids ( O3-FAs ) can be effective in decreasing arthralgia resulting from rheumatologic conditions and reducing serum triglycerides .


Women with early-stage breast cancer receiving an AI who had a worst joint pain/stiffness score 5 of 10 using the Brief Pain Inventory-Short Form ( BPI-SF ) were randomly assigned to receive either O3-FAs 3.3 g or placebo ( soybean/corn oil ) daily for 24 weeks .


Clinically significant change was defined as 2-point drop from baseline .


Patients also completed quality-of-life ( Functional Assessment of Cancer Therapy-Endocrine Symptoms ) and additional pain/stiffness assessments at baseline and weeks 6 , 12 , and 24 .


Serial fasting blood was collected for lipid analysis .


Among 262 patients registered , 249 were evaluable , with 122 women in the O3-FA arm and 127 in the placebo arm .


Compared with baseline , the mean observed BPI-SF score decreased by 1.74 points at 12 weeks and 2.22 points at 24 weeks with O3-FAs and by 1.49 and 1.81 points , respectively , with placebo .


In a linear regression adjusting for the baseline score , osteoarthritis , and taxane use , adjusted 12-week BPI-SF scores did not differ by arm ( P = .58 ) .


Triglyceride levels decreased in patients receiving O3-FA treatment and remained the same for those receiving placebo ( P = .01 ) .


No between-group differences were seen for HDL , LDL , or C-reactive protein .


We found a substantial ( > 50 % ) and sustained improvement in AI arthralgia for both O3-FAs and placebo but found no meaningful difference between the groups .


Rifamycin SV is under development for treatment of travelers ' diarrhea ( TD ) in a new oral formulation , Rifamycin SV MMX ( RIF-MMX ; Santarus Inc. , San Diego , CA , USA ) , which targets its delivery to the colon , making it a unique rifamycin drug .


This was a randomized , double-blind , phase 3 study of adult travelers to Mexico or Guatemala experiencing acute diarrhea .


A total of 264 patients received RIF-MMX ( 2200mg twice daily for 3days , n = 199 ) or placebo ( n = 65 ) in a 3:1 ratio .


The primary endpoint was the length of time between the administration of first dose of study drug and passage of the last unformed stool ( TLUS ; after which clinical cure was declared ) .


Other endpoints included eradication of pathogens from the stools , pathogen minimum inhibitory concentration ( MIC ) , and adverse events ( AEs ) .


TLUS was significantly shorter in the RIF-MMX group ( median : 46.0 hours ) compared with placebo ( median : 68.0 hours ; p = 0.0008 ) and a larger percentage of RIF-MMX treated patients ( 81.4 % ) achieved clinical cure compared with placebo patients ( 56.9 % ) .


TLUS was significantly shorter in the subgroups of patients with enteroaggregative , enterotoxigenic , or diffusely adherent Escherichia coli infections ( p = 0.0035 ) with nonsignificant activity against invasive bacteria ( p = 0.3804 ) .


Overall pathogen eradication rates were numerically higher in the RIF-MMX group ( 67.0 % ) compared with placebo ( 54.8 % ) but the difference did not reach significance ( p = 0.0836 ) .


In vitro resistance to rifamycin SV was observed in some bacteria remaining after treatment of patients with RIF-MMX but was not associated with lower efficacy in them .


AEs appeared to be more frequent with placebo ( 38.5 % ) than with RIF-MMX ( 29.6 % ) .


RIF-MMX shortened the duration of TD in patients with a broad range of pathogens and was well tolerated .


The unique pharmacokinetic properties of the drug offer evidence that TD pathogens work at the level of the colon .


Ethanol celiac plexus neurolysis ( ECPN ) has been shown to be effective in reducing cancer-related pain in patients with locally advanced pancreatic and periampullary adenocarcinoma ( PPA ) .


This study examined its efficacy in patients undergoing PPA resection .


There were 485 patients who participated in this prospective , randomized , double-blind placebo controlled trial .


Patients were stratified by preoperative pain and disease resectability .


They received either ECPN ( 50 % ethanol ) or 0.9 % normal saline placebo control .


The primary endpoint was short - and long-term pain and secondary endpoints included postoperative morbidity , quality of life , and overall survival .


Data from 467 patients were analyzed .


The primary endpoint , the percentage of PPA patients experiencing a worsening of pain compared with preoperative baseline for resectable patients , was not different between the ethanol and saline groups in either the resectable/pain stratum ( 22 % vs 18 % , relative risk [ RR ] 1.23 [ 0.34 , 4.46 ] ) , or the resectable/no pain stratum ( 37 % vs 34 % , RR 1.10 [ 0.67 , 1.81 ] ) .


In multivariable analysis of resected pancreatic ductal adenocarcinoma ( PDA ) patients , there was a significant reduction in pain in the resectable/pain group , suggesting that surgical resection of the malignancy alone ( independent of ECPN ) decreases pain to a significant degree .


In this study , we demonstrated a significant reduction in pain after surgical resection of PPA .


However , the addition of ECPN did not synergize to result in a further reduction in pain , and in fact , its effect may have been masked by surgical resection .


Given this , we can not recommend the use of ECPN to mitigate cancer-related pain in resectable PPA patients .


Atrial fibrillation ( AF ) is a risk factor for ischemic stroke and congestive heart failure .


AF may cause left atrial ( LA ) dyssynchrony as well as electrical and mechanical remodeling .


The aim of this study was to investigate LA dyssynchrony in patients with paroxysmal AF ( PAF ) and its recovery after pulmonary vein isolation ( PVI ) , using a three-dimensional strain method .


Thirty patients with PAF who underwent PVI were enrolled .


Three-dimensional echocardiography was performed before and 3months after PVI .


Twenty subjects in whom AF had never been detected served as controls .


LA dyssynchrony was quantified by the standard deviation of time to peak strain ( TP-SD ) from end-diastole by area tracking .


Serial changes in TP-SD , LA volume , and global strain in three-dimensional echocardiography were investigated .


In the PAF group , TP-SD was significantly higher ( 9.194.98 % vs 4.802.30 % in controls , P < .02 ) and global strain significantly lower ( 48.220.2 % vs 84.432.9 % in controls , P = .0003 ) than in the control group .


TP-SD , global strain , and LA volume all improved significantly from before to after PVI ( TP-SD , from 9.194.98 % to 6.312.94 % , P = .005 ; global strain , from 48.220.2 % to 58.121.2 % , P = .018 ; LA volume index , 29.510.6 to 25.87.1 mL/m ( 2 ) , P = .04 ) .


Despite the improvement after PVI , TP-SD was still significantly higher and global strain lower than in controls .


In patients with PAF , impaired LA function was documented by three-dimensional echocardiography .


Despite early LA structural reverse remodeling , LA dyssynchrony was still observed 3 months after PVI .


These results may affect medical therapy after successful PVI .


To evaluate the relative pain with 3 U.S. Food and Drug Administration-approved bandage soft contact lenses ( SCLs ) applied after photorefractive keratectomy ( PRK ) .


Joint Warfighter Refractive Surgery Center , Lackland Air Force Base , Texas , USA .


Prospective comparative case series .


Patients having PRK were randomized to a senofilcon A ( Acuvue Oasys ) , balafilcon A ( Purevision ) , or lotrafilcon A ( Air Optix ) bandage SCL in each eye postoperatively .


Patients were evaluated 1 and 4 days postoperatively and completed a survey rating absolute pain in each eye on a visual analog scale .


The study enrolled 54 patients .


At 1 and 4 days , eyes with the senofilcon A lens had the lowest pain scores followed by eyes with the lotrafilcon A lens and then eyes with the balafilcon A lens .


Averaging qualitative results from 1 and 4 days showed that eyes with the senofilcon A lens were reported as having more pain by 4 % of patients , eyes with the lotrafilcon A lens by 27 % , and eyes with the balafilcon A lens by 53 % ; 16 % reported no difference ( P < .001 ) .


Quantitatively , the senofilcon A lens was 40 % more comfortable than the lotrafilcon A lens and 65 % more comfortable than the balafilcon A lens on average .


The lotrafilcon A lens was 38 % more comfortable than the balafilcon A lens on average ( P < .01 ) .


There was a statistically and clinically significant difference in post-PRK pain between the 3 bandage SCLs .


The senofilcon A lens caused the least pain .


Dr. Reilly is a consultant to Alcon Laboratories , Inc. and Abbott Medical Optics , Inc. but was not at the time of the study .


No other author has a financial or proprietary interest in any material or method mentioned .


In an unselected group of women with signs of preterm labour , maintenance tocolysis is not effective in the prevention of preterm birth and does not improve neonatal outcome .


Among women with signs of preterm labour , those who are fetal fibronectin positive have an increased risk of preterm birth .


We investigated whether maintenance tocolysis with nifedipine would delay delivery and improve neonatal outcome in women with threatened preterm labour and a positive fetal fibronectin status .


Women with a singleton pregnancy in threatened preterm labour ( 24 ( +0 ) to 33 ( +6 ) weeks ) with a positive fetal fibronectin test were randomised to nifedipine or placebo .


Study medication was continued until 36 completed weeks ' gestation .


The primary endpoint was prolongation of pregnancy of sevendays .


Secondary endpoints were gestational age at delivery and length of NICU admission .


Of the 60 participants , 29 received nifedipine and 31 placebo .


Prolongation of pregnancy by > 7days occurred in 22/29 ( 76 % ) in the nifedipine group and 25/31 ( 81 % ) in the placebo group ( relative risks , RR 0.94 [ 0.72-1 .2 ] ) .


Gestational age at delivery was 36.15.1 weeks for nifedipine and 36.83.6 weeks for placebo ( P = 0.027 ) .


Length of NICU admission [ median ( interquartile ranges , IQR ) ] was 27 ( 24-41 ) days and 16 ( 8-37 ) days in nifedipine and placebo groups , respectively ( P = 0.17 ) .


In women with threatened preterm labour who are fetal fibronectin positive , maintenance tocolysis with nifedipine does not seem to prolong pregnancy , nor reduce length of NICU admission .


Randomized placebo-controlled trials represent the gold standard in evaluating healthcare interventions but are rarely performed within orthopedics .


Ethical concerns or well-known challenges in recruiting patients for surgical trials in general have been expressed and adding a placebo component only adds to this complexity .


The purpose of this study was to report the challenges of recruiting patients into an orthopedic placebo-controlled surgical trial , to determine the number of patients needed to be screened and allocated in order to include one participant into the trial , and to identify reasons associated with participation in a placebo-controlled randomized surgical trial .


Data were extracted from an ongoing placebo-controlled randomized controlled trial ( RCT ) on meniscectomy versus placebo surgery .


We calculated the number of patients needed to be screened in order to include the required number of participants into the RCT .


Participating patients were asked about their rationale for joining the study and which type of information was most useful for deciding upon participation .


A total of 476 patients entered the screening group , of which 190 patients fulfilled the inclusion and exclusion criteria .


102 patients declined to participate in the study due to various reasons and 46 were later excluded ( no meniscus lesion on the magnetic resonance imaging scan or withdrawn consent ) .


A total of 40 patients were finally included in the RCT .


To include one patient into the RCT , 11.9 individuals needed to be screened .


A total of 69 % of participating patients considered the oral information to be the most important and the most common reason for participating was the contribution to research ( 90 % ) .


Patients are willing to participate in an orthopedic placebo-controlled surgical trial .


Oral information given by the surgeon to the patient and the contribution to research are important aspects to enhance patient recruitment .


ClinicalTrials.gov NCT01264991 , registered 21 December 2010 .


The aim of the study was to determine whether low-level laser therapy ( LLLT ) has an analgesic effect in patients with recurrent aphthous stomatitis ( RAS ) .


A randomized single-blinded placebo-controlled trial was conducted with LLLT ( wavelength , 809 nm ; power , 60 mW ; pulse frequency , 1800 Hz ; duration , 80 seconds per treatment ; dose , 6.3 J/cm ( 2 ) ) in 40 patients with RAS .


The intervention group was treated with LLLT on 3 occasions , with a 1-day interval .


The control group was treated similarly , without any laser power .


Pain perception ( visual analog scale [ VAS ] rating ) and patients ' experience of eating , drinking , and brushing teeth was registered .


VAS rating decreased ( day 0 until day 2 ) from 84.7 to 31.5 ( LLLT ) and from 81.7 to 76.1 ( placebo ) ( P < .0001 ) .


LLLT also relieved the difficulty of drinking , eating , and brushing teeth .


LLLT reduced the pain and the inconvenience of eating , drinking , and brushing teeth for patients with RAS , compared with placebo .


Children in care often have poor outcomes .


There is a lack of evaluative research into intervention options .


To examine the efficacy of Multidimensional Treatment Foster Care for Adolescents ( MTFC-A ) compared with usual care for young people at risk in foster care in England .


A two-arm single ( assessor ) blinded randomised controlled trial ( RCT ) embedded within an observational quasi-experimental case-control study involving 219 young people aged 11-16 years ( trial registration : ISRCTN 68038570 ) .


The primary outcome was the Child Global Assessment Scale ( CGAS ) .


Secondary outcomes were ratings of educational attendance , achievement and rate of offending .


The MTFC-A group showed a non-significant improvement in CGAS outcome in both the randomised cohort ( n = 34 , adjusted mean difference 1.3 , 95 % CI -7.1 to 9.7 , P = 0.75 ) and in the trimmed observational cohort ( n = 185 , adjusted mean difference 0.95 , 95 % CI -2.38 to 4.29 , P = 0.57 ) .


No significant effects were seen in secondary outcomes .


There was a possible differential effect of the intervention according to antisocial behaviour .


There was no evidence that the use of MTFC-A resulted in better outcomes than usual care .


The intervention may be more beneficial for young people with antisocial behaviour but less beneficial than usual treatment for those without .


To study the mutual pharmacokinetic interactions between macitentan , an endothelin receptor antagonist , and sildenafil in healthy male subjects .


In this open-label , randomized , three way crossover study , 12 healthy male subjects received the following oral treatments : A ) a loading dose of 30mg macitentan on day 1 followed by 10mg once daily for 3 days , B ) sildenafil 20mg three times a day for 3 days and a single 20mg dose on day 4 and C ) both treatments A and B concomitantly .


Plasma concentration-time profiles of macitentan and its active metabolite ACT-132577 ( treatments A and C ) and sildenafil and its N-desmethyl metabolite ( treatments B and C ) were determined on day 4 and analyzed non-compartmentally .


The pharmacokinetics of macitentan were not affected by sildenafil .


In the presence of sildenafil Cmax and AUC of the metabolite ACT-132577 decreased with geometric mean ratios ( 90 % confidence interval ( CI ) ) of 0.82 ( 0.76 , 0.89 ) and 0.85 ( 90 % CI 0.80 , 0.91 ) , respectively .


In the presence of macitentan , plasma concentrations of sildenafil were higher than during treatment with sildenafil alone , resulting in increased Cmax and AUC values .


The respective geometric mean ratios were 1.26 ( 90 % CI 1.07 , 1.48 ) and 1.15 ( 90 % CI 0.94 , 1.41 ) .


The pharmacokinetics of N-desmethylsildenafil were not affected by macitentan .


All treatments were well tolerated .


A minor , not clinically relevant , pharmacokinetic interaction was observed between macitentan and sildenafil .


Based on these results , no dose adjustment of either compound appears necessary during concomitant treatment with macitentan and sildenafil .


To compare clinical effects of spinal leveraging manipulation and medicine for the treatment of degenerative scoliosis in pain and function .


From July 2010 to June 2013 , 38 patients with degenerative scoliosis were randomly divided into spinal leveraging manipulation group and medicine group by coin tossing .


In manipulation group , there were 9 males and 11 females aged from 58 to 74 years old with an average of ( 66.637.73 ) , the courses of diseases ranged from 3 to 8 months with an average of ( 5.652.58 ) , spinal leveraging manipulation ( following meridian to straighten tendon , relieving spasm , osteopathy and massage , clearing and activating the channels and collaterals ) were performed for 30 min , once a day , 4 days for a period treatment , totally 9 courses .


In medicine group , there were 8 males and 10 females aged from 57 to 70 years old with an average of ( 63.516.61 ) the courses of diseases ranged from 3 to 5 months with an average of ( 4.821.43 ) , celecoxib with eperisone hydrochloride were orally taken , 4 days for a period treatment , totally 9 courses .


VAS score , Cobb angle and ODI score were measured .


After treatment , VAS score in manipulation group was ( 5.380.99 ) , ( 6.361.31 ) in medicine group , and had significant meaning ( t = 2.618 , P < 0.05 ) ; there was significant differences in Cobb angle between manipulation group ( 16.514.89 ) and medicine group ( 19.855.03 ) ( t = 2.074 , P < 0.05 ) ; and had obviously meaning in ODI score between manipulation group ( 20.202.93 ) and medicine group ( 26.013.11 ) ( t = 5.592 , P < 0.05 ) .


Spinal leveraging manipulation for degenerative scoliosis could regulate muscle balance on both side of spine , correct coronal imbalances in spine , recover normal sequence of spine , reduce and remove opperssion and stimulation of nerve root , relieve pain in leg and waist and further improve quality of life .


To evaluate the efficacy ofprobiotics , Lactobacillus casei ( Shirvta strain ) , in reducing the incidence ofventilator - associated pneumonia ( VAP ) in medical patients who received mechanical ventilation at Siriraj Hospital .


A prospective , randomized , open-label controlled trial was conducted in 150 adult hospitalized patients in medical wards who were expected to receive mechanical ventilation for 72 hours or longer : The patients were randomized to the probiotics group or the control group .


All patients received regular care for mechanical ventilation .


The patients in the probiotics group received 80 ml of Lactobacillus casei ( Shirota strain ) for oral care after having standard oral care once daily and additional 80 ml of the aforementionedfermented dairy product was given via enteralfeeding once daily .


The primary outcomes were incidence of VAP and incidence rate of VAP episodes per 1,000 ventilator-days .


The secondary outcomes were length ofhospital stay , mortality at day 28 and 90 , incidence ofdiarrhea , andpresence of resistant bacteria in oropharyngeal and rectal swab samples taken from the patients at baseline , day 7 and day 28 after enrollment .


The baseline characteristics of the patients in the probiotics group ( 75 ) and the control group ( 75 ) were not significantly different .


The patients in the probiotics group were less likely to develop VAP compared with the control group ( 24 % vs. 29.3 % , p = 0.46 ) , respectively .


The incidence rates of VAP in the probiotics and control groups were 22.64 and 30.22 episodes per 1,000 ventilator-days , respectively ( p = 0.37 ) .


A trend of lower prevalence of some resistant bacteria cultured from oropharyngeal swabs in the probiotics group than that in the control group was observed .


Overall 28 - and 90-day mortality and length of hospital stay of the patients in both groups were not significantly different .


Administration of probiotics containing Lactobacillus casei ( Shirota strain ) has a tendency to reduce the incidence of VAP and colonization with resistant bacteria in oropharyngeal cavity without significant effects on mortality and length of hospital stay .


Angiogenesis is crucial for glioblastoma growth , and anti-vascular endothelial growth factor agents are widely used in recurrent glioblastoma patients .


The number of circulating endothelial cells ( CECs ) is a surrogate marker for endothelial damage .


We assessed their kinetics and explored their prognostic value in patients with recurrent glioblastoma .


In this side study of the BELOB trial , 141 patients with recurrent glioblastoma were randomised to receive single-agent bevacizumab or lomustine , or bevacizumab plus lomustine .


Before treatment , after 4 weeks and after 6 weeks of treatment , CECs were enumerated .


The number of CECs increased during treatment with bevacizumab plus lomustine , but not during treatment in the single-agent arms .


In patients treated with lomustine single agent , higher absolute CEC numbers after 4 weeks ( logCEC hazard ratio ( HR ) 0.41 , 95 % CI 0.18-0 .91 ) and 6 weeks ( logCEC HR 0.16 , 95 % CI 0.05-0 .56 ) of treatment were associated with improved overall survival ( OS ) .


Absolute CEC numbers in patients receiving bevacizumab plus lomustine or bevacizumab single agent were not associated with OS .


CEC numbers increased during treatment with bevacizumab plus lomustine but not during treatment with either agent alone , suggesting that this combination induced the greatest vascular damage .


Although the absolute number of CECs was not associated with OS in patients treated with bevacizumab either alone or in combination , they could serve as a marker in glioblastoma patients receiving lomustine single agent .


Patients with traumatic knee complaints regularly consult their general practitioner ( GP ) .


MRI might be a valuable diagnostic tool to assist GPs in making appropriate treatment decisions and reducing costs .


Therefore , this study will assess the cost-effectiveness of referral to MRI by GPs compared with usual care , in patients with persistent traumatic knee complaints .


This is a multi-centre , open-labelled randomised controlled non-inferiority trial in combination with a concurrent observational cohort study .


Eligible patients ( aged 18-45 years ) have knee complaints due to trauma ( or sudden onset ) occurring in the preceding 6 months and consulting their GP .


Participants are randomised to : 1 ) an MRI group , i.e. GP referral to MRI , or 2 ) a usual care group , i.e. no MRI .


Primary outcomes are knee-related daily function , medical costs ( healthcare use and productivity loss ) , and quality of life .


Secondary outcomes are disability due to knee complaints , severity of knee pain , and patients ' perceived recovery and satisfaction .


Outcomes are measured at baseline and at 1.5 , 3 , 6 , 9 and 12 months follow-up .


Also collected are data on patient demographics , GPs ' initial working diagnosis , GPs ' preferred management at baseline , and MRI findings .


In the Netherlands , the additional diagnostic value and cost-effectiveness of direct access to knee MRI for patients presenting with traumatic knee complaints in general practice is unknown .


Although GPs increasingly refer patients to MRI , the Dutch clinical guideline ` Traumatic knee complaints ' for GPs does not recommend referral to MRI , mainly because the cost-effectiveness is still unknown .


Dutch Trial Registration : NTR3689 .


Cervical spondylotic myelopathy ( CSM ) is the most common cause of spinal cord dysfunction in the world .


There are significant practice variation and uncertainty as to the optimal surgical approach for treating CSM .


To determine whether ventral surgery is associated with superior Short Form-36 Physical Component Summary outcome at the 1-year follow-up compared with dorsal ( laminectomy/fusion or laminoplasty ) surgery for the treatment of CSM , to investigate whether postoperative sagittal balance is an independent predictor of overall outcome , and to compare health resource use for ventral and dorsal procedures .


The study is a randomized , controlled trial with a nonrandomized arm for patients who are eligible but decline randomization .


Two hundred fifty patients ( 159 randomized ) with CSM from 11 sites will be recruited over 18 months .


The primary outcome is the Short Form-36 Physical Component Summary score .


Secondary outcomes include disease-specific outcomes , overall health-related quality of life ( EuroQOL 5-dimension questionnaire ) , and health resource use .


This will be the first randomized , controlled trial to compare directly the health-related quality-of-life outcomes for ventral vs dorsal surgery for treating CSM .


A National Institutes of Health-funded ( 1R13AR065834-01 ) investigator meeting was held before the initiation of the trial to bring multiple stakeholders together to finalize the study protocol .


Study investigators , coordinators , and major stakeholders were able to attend and discuss strengths of , limitations of , and concerns about the study .


The final protocol was approved for funding by the Patient-Centered Outcomes Research Institute ( CE-1304-6173 ) .


The trial began enrollment on April 1 , 2014 .


Silicone excipients are commonly used ingredients because of their emollient and skin-conditioning effects , and their ability to form uniform , water-resistant , yet permeable films .


Based on comparisons with organic materials and conflicting knowledge from silicones used in scar treatment , the misconception still exists that silicone topical excipients are occlusive substances that may block the passive loss of water through the upper skin layers .


Therefore , 3 types of common silicone excipients and 3 water-in - ( oil-plus-silicone ) or W / ( O + Si ) creams , containing 10 % ( w/w ) of the respective silicones , were investigated as a function of time and compared to petrolatum .


Transepidermal water loss ( TEWL ) and skin hydration measurements were carried out after a single topical application on forearm skin of 26 healthy young female volunteers .


Both petrolatum and silicones significantly decreased TEWL 15 min after application , but the measurements for the silicones were not significantly different from the untreated control values .


The tested silicones did not moisturize the skin .


Petrolatum formed an occlusive layer , creating an increase in skin hydration for more than 4 h.


The results measured for the W / ( O + Si ) creams indicated that they moisturized the skin , without any effect on TEWL .


A clear difference was shown between the skin occlusive properties of petrolatum and the water vapor permeability of the common silicone excipient materials .


The aim of this study is to evaluate the effectiveness of life review ( LR ) based on specific positive events in non-depressed older adults taking part in an active aging program .


Fifty-five older adults were randomly assigned to an experimental group or an active control ( AC ) group .


A six-session individual training of LR based on specific positive events was carried out with the experimental group .


The AC group undertook a `` media workshop '' of six sessions focused on learning journalistic techniques .


Pre-test and post-test measures included life satisfaction , depressive symptoms , experiencing the environment as rewarding , and autobiographical memory ( AM ) scales .


LR intervention decreased depressive symptomatology , improved life satisfaction , and increased specific memories .


The findings suggest that practice in AM for specific events is an effective component of LR that could be a useful tool in enhancing emotional well-being in active aging programs , thus reducing depressive symptoms .


Although colonoscopy is the accepted standard for detection of colorectal adenomas and cancers , many adenomas and some cancers are missed .


To avoid interval colorectal cancer , the adenoma miss rate of colonoscopy needs to be reduced by improvement of colonoscopy technique and imaging capability .


We aimed to compare the adenoma miss rates of full-spectrum endoscopy colonoscopy with those of standard forward-viewing colonoscopy .


We did an international , multicentre , randomised trial at three sites in Israel , one site in the Netherlands , and two sites in the USA between Feb 1 , 2012 , and March 31 , 2013 .


Patients aged 18-70 years referred for colorectal cancer screening , polyp surveillance , or diagnostic assessment underwent same-day , back-to-back tandem colonoscopy with standard forward-viewing colonoscope and the full-spectrum endoscopy colonoscope .


The patients were randomly assigned ( 1:1 ) , via computer-generated randomisation with block size of 20 , to which procedure was done first .


The endoscopist was masked to group allocation until immediately before the start of colonoscopy examinations ; patients were not masked .


The primary endpoint was adenoma miss rates .


We did per-protocol analyses .


This trial is registered with ClinicalTrials.gov , number NCT01549535 .


197 participants were enrolled .


185 participants were included in the per-protocol analyses : 88 ( 48 % ) were randomly assigned to receive standard forward-viewing colonoscopy first , and 97 ( 52 % ) to receive full-spectrum endoscopy colonoscopy first .


By per-lesion analysis , the adenoma miss rate was significantly lower in patients in the full-spectrum endoscopy group than in those in the standard forward-viewing procedure group : five ( 7 % ) of 67 vs 20 ( 41 % ) of 49 adenomas were missed ( p < 00001 ) .


Standard forward-viewing colonoscopy missed 20 adenomas in 15 patients ; of those , three ( 15 % ) were advanced adenomas .


Full-spectrum endoscopy missed five adenomas in five patients in whom an adenoma had already been detected with first-pass standard forward-viewing colonoscopy ; none of these missed adenomas were advanced .


One patient was admitted to hospital for colitis detected at colonoscopy , whereas five minor adverse events were reported including vomiting , diarrhoea , cystitis , gastroenteritis , and bleeding .


Full-spectrum endoscopy represents a technology advancement for colonoscopy and could improve the efficacy of colorectal cancer screening and surveillance .


EndoChoice .


Patients with previous coronary artery bypass grafting ( CABG ) who underwent percutaneous coronary intervention ( PCI ) have an increased repeat revascularization rate , but data on contemporary second-generation drug-eluting stents ( DES ) are scarce .


We evaluated 1-year clinical outcome following secondary revascularization by PCI in patients of the TWENTE trial and non-enrolled TWENTE registry , and compared patients with previous CABG versus patients without previous CABG .


Of all 1709 consecutive patients , 202 ( 11.8 % ) had previously undergone CABG ( on average 11.28.5 years ago ) .


CABG patients were older ( 68.59.4 years vs. 64.110.7 years , P < 0.001 ) and more often had diabetes ( 28.7 % vs. 20.9 % , P = 0.01 ) and previous PCI ( 40.1 % vs. 19.8 % , P < 0.001 ) compared to patients without previous CABG .


Nevertheless , a higher target vessel revascularization ( TVR ) rate following PCI in the CABG patients ( 9.4 % vs. 2.3 % , P < 0.001 ) was the only significant difference in clinical outcome at 1-year follow-up ( available for 99.6 % ) .


Among CABG patients , the TVR rate was significantly higher in patients treated for graft lesions ( n = 65 ; 95.4 % in vein grafts ) than in patients treated for native coronary lesions only ( n = 137 ) ( 18.5 % vs. 5.1 % , P = 0.002 ) .


Among 1638 patients with PCI of native coronary lesions only , there was only a non-significant difference in TVR between patients with previous CABG versus patients without previous CABG ( 5.1 % vs. 2.3 % , P = 0.08 ) .


Patients with previous CABG showed a favorable safety profile after PCI with second-generation DES .


Nevertheless , their TVR rate was still much higher , driven by more repeat revascularizations after PCI of degenerated vein grafts .


In native coronary lesions , there was no such difference .


The aim of this study was to compare endothelial cell loss and graft success 6 months after endothelial keratoplasty ( EK ) with paired donor corneas stored in Optisol GS and Life4C solutions and their associated storage chambers .


Donor pairs were stored , one in Optisol GS and the other in Life4C , and prepared for Descemet stripping automated EK or Descemet membrane EK .


Matched pairs of recipients with Fuchs dystrophy were randomized to 1 member of each donor pair .


Clarity of recipient stroma , intraocular pressure , and complications were followed for 6 months .


Central endothelial images of the donor cornea at screening and 3 and 6 months after EK were analyzed by a masked central reading center .


Dual grading of endothelial cell density was performed using the center method .


Differences in endothelial cell density and cell loss were examined by paired analysis .


Thirty-two pairs were enrolled , and 27 were analyzed ( 5 had improper matching or loss to follow-up ) .


Donor age was 59 14 years , median death-to-surgery time was 4 days ( range , 2-9 days ) , 6 recipient pairs had Descemet membrane EK , and 21 had Descemet stripping automated EK .


Recipient age was comparable in the Optisol GS and Life4C groups ( 70 vs. 68 years , respectively , P = 0.46 ) .


Six-month central endothelial cell loss did not differ significantly between the Life4C and Optisol GS groups ( 18 18 % vs. 20 20 % , respectively , P = 0.55 ) .


All recipient corneas were clear at 6 months in both groups .


Endothelial cell loss and graft success were comparable at 6 months for paired donor corneas stored in Optisol GS and Life4C.Clinical Trial Registration-URL : http://www.clinicaltrials.gov .


Unique identifier : NCT01657500 .


To evaluate the process of implementation of a social and physical environmental intervention and to explore differences regarding this process between both interventions .


Context , recruitment , dose delivered , fidelity , reach , dose received , satisfaction , and implementation barriers were investigated .


Reach for the social and physical environmental interventions ranged from 45 % to 76 % .


Mean satisfaction for the social environmental intervention was 6.0 and for the physical environmental intervention was 7.0 .


Generally , the results were higher for team leaders than for employees .


Furthermore , the implementation of the physical intervention was better at the departments that additionally received the social intervention .


Both interventions were better implemented on the level of the team leader than that of the employees .


Furthermore , the combined interventions received higher evaluation scores .


To increase satisfaction and participation , attention should be paid to both employees and team leaders during implementation .


We aimed to identify salutogenic patterns of parental knowledge , behaviors , attitudes , and beliefs that may support resistance to early childhood caries ( ECC ) among a high caries population of preschool American Indian ( AI ) children .


Participants were 981 child-parent dyads living on a Southwestern reservation who completed baseline assessments for an ongoing randomized clinical trial .


T-tests were used to assess differences between reported knowledge , behaviors , and beliefs of parents whose children were caries-free ( 10.7 percent ) and those whose children had caries ( 89.3 percent ) .


Chi-square analyses were used for categorical variables .


Although there were no socio-demographic differences , parents of caries-free children viewed oral health as more important and reported more oral health knowledge and adherence to caries-preventing behaviors for their children .


Parents of caries-free children were more likely to have higher internal locus of control , to perceive their children as less susceptible to caries , and to perceive fewer barriers to prevention .


These parents also had higher sense of coherence scores and reported lower levels of personal distress and community-related stress .


Effective interventions for ECC prevention in high-caries AI populations may benefit from approaches that support and model naturally salutogenic behaviors .


Physical activity has a positive effect on people 's mental health and well-being .


The aim of this study was to compare the effects of hatha yoga and resistance exercises on mental health and well-being in sedentary adults .


Randomized controlled study .


Fifty-one participants aged mean ( SD ) 25.6 ( 5.7 ) years were randomly divided into three groups : Hatha Yoga Group , Resistance Exercise Group and Control Group .


The Hatha Yoga Group and Resistance Exercise Group participated in sessions three days per week for 7 weeks and the Control Group did not participate in any sessions .


All the subjects were evaluated through the Rosenberg Self-Esteem Scale , Beck Depression Inventory , Body Cathexis Scale , Nottingham Health Profile and Visual Analog Scale for fatigue pre-and post-session .


Significant improvements were found in terms of all outcome measures in the Hatha Yoga Group and the resistance exercise group .


No improvements were found in the Control Group .


Hatha yoga more improved the dimensions fatigue , self-esteem , and quality of life , whilst resistance exercise training more improved body image .


Hatha yoga and resistance exercise decreased depression symptoms at a similar level .


The results indicated that hatha yoga and resistance exercise had positive effects on mental health and well-being in sedentary adults .


Hatha yoga and resistance exercise may affect different aspects of mental health and well-being .


Molecular imaging using positron emission tomography/computerized tomography ( PET/CT ) may add relevant incremental diagnostic information to standard structural cross-sectional imaging .


Such information may allow identification of patients with rectal cancer that are more likely to develop complete tumor regression after neoadjuvant chemoradiation therapy ( CRT ) .


The objective of this report was to identify PET/CT features that are associated with a complete response after CRT .


99 cT2-4N0-2M0 distal rectal cancer patients ( 7 cm from anal verge ) were included in this prospective single center trial ( NCT 00254683 ) .


Patients underwent baseline PET/CT followed by 54 Gy and 5-fluorouracil-based neoadjuvant CRT .


After completion of therapy , patients underwent 6 - and 12-week PET/CT .


Clinical assessment of tumor response was performed at 12 weeks and was blinded to radiological information .


Patients were treated according to clinical assessment .


There were seven patients with a complete pathological response ( pCR ) and 16 with a complete clinical response ( cCR ) ( 23 complete responders ) .


Comparison of pCR exclusively and non-pCR revealed that only baseline primary tumor standard uptake value ( SUV ) was a significant predictor of response .


Comparison of complete responders ( pCR or cCR ) and non-complete responders showed that depth of rectal wall uptake at baseline PET/CT ( p = 0.002 ) and variation between baseline and 12-week maximum standard uptake value ( SUVmax ) of primary tumor ( p = 0.001 ) were independent predictors for complete response at multivariate analysis .


A decrease > 67 % between baseline and 6-week or 76 % between baseline and 12-week SUVmax were associated with complete response ( pCR or cCR ; p = 0.02 and p < 0.001 , respectively ) .


Positron emission tomography/computerized tomography at baseline , 6 and 12 weeks , may provide information regarding patients with a higher likelihood of developing complete tumor regression following neoadjuvant CRT .


Acupuncture is often used for primary dysmenorrhea .


But there is no convincing evidence due to low methodological quality .


We aim to assess immediate effect of acupuncture at specific acupoint compared with unrelated acupoint and nonacupoint on primary dysmenorrhea .


The Acupuncture Analgesia Effect in Primary Dysmenorrhoea-II is a multicenter controlled trial conducted in six large hospitals of China .


Patients who met inclusion criteria were randomly assigned to classic acupoint ( N = 167 ) , unrelated acupoint ( N = 167 ) , or non-acupoint ( N = 167 ) group on a 1:1:1 basis .


They received three sessions with electro-acupuncture at a classic acupoint ( Sanyinjiao , SP6 ) , or an unrelated acupoint ( Xuanzhong , GB39 ) , or nonacupoint location , respectively .


The primary outcome was subjective pain as measured by a 100-mm visual analog scale ( VAS ) .


Measurements were obtained at 0 , 5 , 10 , 30 , and 60 minutes following the first intervention .


In addition , patients scored changes of general complaints using Cox retrospective symptom scales ( RSS-Cox ) and 7-point verbal rating scale ( VRS ) during three menstrual cycles .


Secondary outcomes included VAS score for average pain , pain total time , additional in-bed time , and proportion of participants using analgesics during three menstrual cycles .


Five hundred and one people underwent random assignment .


The primary comparison of VAS scores following the first intervention demonstrated that classic acupoint group was more effective both than unrelated acupoint ( -4.0 mm , 95 % CI -7.1 to -0.9 , P = 0.010 ) and nonacupoint ( -4.0 mm , 95 % CI -7.0 to -0.9 , P = 0.012 ) groups .


However , no significant differences were detected among the three acupuncture groups for RSS-Cox or VRS outcomes .


The per-protocol analysis showed similar pattern .


No serious adverse events were noted .


Specific acupoint acupuncture produced a statistically , but not clinically , significant effect compared with unrelated acupoint and nonacupoint acupuncture in primary dysmenorrhea patients .


Future studies should focus on effects of multiple points acupuncture on primary dysmenorrhea .


There is an increased demand for the reduction of localized adipose tissue by noninvasive methods .


The objective of this study was to determine the safety and efficacy of noninvasive lipolysis of excess adiposities overlying the lateral thigh region using acoustic wave therapy ( AWT ) .


This study incorporates 2 mechanical waves with varying properties in the same session : radial and planar AWT .


The treatment was performed using AWT on the lateral thigh areas of 15 female patients .


The study was performed using the planar and radial pulse handpieces , with 8 sessions performed within 4 weeks .


Follow-up visits were performed 1 , 4 , and 12 weeks after the last treatment .


Reduction in both thigh circumference and subcutaneous fat layer thickness , measured through ultrasound , was observed .


This study demonstrates that AWT is safe and efficacious for the treatment of localized adiposities in the saddlebag area .


However , the results obtained were not statistically significant .


Larger studies will be needed to further access the effects of AWT on thigh circumference reduction .


Furthermore , the authors also found an improvement in the appearance of both cellulite and skin firmness after the treatments .


Periarticular injection is becoming more commonly utilized for pain relief following total knee arthroplasty .


However , we are aware of no randomized controlled trial that has investigated the efficacy of periarticular injection for pain relief after simultaneous bilateral total knee arthroplasty .


We performed a randomized controlled trial of patients scheduled for simultaneous bilateral total knee arthroplasty .


Seventy-one patients with 142 involved knees were randomly assigned to receive periarticular injection or epidural analgesia .


Other perioperative interventions , including spinal anesthesia , surgical techniques , and postoperative medication protocols , were identical for all patients .


The primary outcome was postoperative pain at rest , measured with the use of a 100-mm visual analog scale ( VAS ) during the initial twenty-four-hour postoperative period .


The cumulative VAS score was calculated with use of the area under the curve and compared between the groups .


Postoperative pain at rest , quantified as the area under the curve of serial assessments during the initial twenty-four-hour postoperative period , was significantly less in the periarticular injection group than in the epidural analgesia group ( 174.9 181.5 mm day compared with 360.4 360.6 mm day ; p = 0.0073 ) .


The prevalences of nausea on the night of surgery and postoperative day 1 and of pruritus were significantly lower in the periarticular injection group than in the epidural analgesia group ( 14 % and 45 % , p = 0.0031 ; 14 % and 55 % , p = 0.0003 ; and 0 % and 15 % , p = 0.014 , respectively ) .


Periarticular injection was associated with better pain relief during the first twenty-four hours following simultaneous bilateral total knee arthroplasty and decreased opioid-related side effects compared with epidural analgesia .


Periarticular injection may be preferable to epidural analgesia for pain relief after simultaneous bilateral total knee arthroplasty .


Management of low back pain after spinal surgeries is one of the most challenging problems in pain medicine .


Transforaminal lumbar epidural steroid injection has been used with inconsistent response .


Most patients require multiple and frequent injections due to high recurrence of back pain .


To find out whether the addition of hyaluronidase to the epidural injectate affects the quality and duration of analgesia in patients with low back pain secondary to failed back surgery syndrome .


Prospective randomized trial .


The study was registered in the Government Clinical Trial registry and the protocol was reviewed and approved by the institutional review board .


After obtaining an informed consent , 25 patients with low back pain due to failed back syndrome were randomly assigned to receive a transforaminal epidural injection of hyaluronidase 1500 IU ( HYL ) or normal saline ( NSL ) to a mixture of bupivacaine 0.5 % ( 1 mL ) and triamcinolone 40 mg ( 1 mL ) in a double-blind fashion .


An interventional pain specialist using fluoroscopic guidance performed all epidural injections .


The patients received a comprehensive neurological examination by a non-interventional pain specialist who was blinded to the treatment during their follow-up visits , scheduled one , 2 , and 4 weeks after the intervention .


Numerical pain scores , analgesic requirement , and satisfaction scores were recorded during every visit .


There was no difference in demographic data between the 2 groups .


Pain scores and total analgesic requirement were significantly lower in the HYL group at 2 and 4 weeks after blockade ( P < 0.01 ) .


Patient satisfaction was higher in the HYL group .


The study was limited by a relatively small sample size .


We conclude that adding hyaluronidase to the epidural injectate was effective in the management of chronic low back pain in patients with failed back surgery syndrome demonstrated over a period of 4 weeks .


Creating the visual illusion of touch can improve tactile perception in healthy subjects .


We were interested in seeing if creating the illusion of touch in an insensate area could improve sensation in that area .


Fourteen people with chronic numbness participated in a randomized crossover experiment .


The 4 conditions were the following : ( a ) stimulation over the unaffected limb with mirror visual feedback ( experimental condition ) , ( b ) stimulation over the affected limb with mirror visual feedback , ( c ) stimulation over the unaffected limb without mirror visual feedback , and ( d ) stimulation over the affected limb without mirror visual feedback .


Participants were assessed before and after each condition using the Ten-Test and mechanical detection thresholds .


Data were analyzed using linear mixed models .


Only the experimental condition produced a change in the Ten-Test ( mean difference = -1.1 ; 95 % confidence interval = -1.8 to -0.4 ; P = .003 ) , corresponding to a 24 % improvement in sensation .


No differences were observed for any condition in mechanical detection thresholds .


Creating the illusion of touch may improve sensory function in areas of chronic numbness .


This preliminary finding adds to the growing body of evidence supporting the use of techniques that directly target cortical function in people with peripheral nerve injury .


A number of studies have described influenza vaccination coverage during pregnancy but few publications have described rates of other vaccinations .


To describe vaccination rates during pregnancy in the Vaccine Safety Datalink ( VSD ) , with particular focus on vaccinations contraindicated during pregnancy .


Pregnancies ending in 2002 through 2009 and vaccinations administered during these pregnancies were identified in the VSD .


Vaccination rates per 1000 pregnancies during the study period were calculated by vaccine type , recommendation category , pregnancy year , maternal age , and trimester .


Analyses were conducted in 2012-2013 .


In the VSD , 669,695 pregnancies and 141,389 vaccinations were identified .


Trivalent inactivated influenza ( TIV ) was the most commonly administered vaccination ( 174.1 doses per 1000 pregnancies ) and was most often administered during the 2nd and 3rd trimesters .


The most common vaccines in the `` consider if indicated '' category were tetanus-diphtheria ( 6.1 per 1000 ) and hepatitis B ( 3.7 per 1000 ) .


Contraindicated vaccination was infrequent , and the majority of these were measles-mumps-rubella ( MMR ) ( 1.2 per 1000 ) ; varicella ( 1.0 per 1000 ) ; and live-attenuated influenza vaccine ( LAIV ) ( 0.3 per 1000 ) .


Both `` consider if indicated '' and contraindicated vaccines were more frequently administered during early pregnancy .


TIV was the most commonly administered vaccine .


With the exception of TIV , other vaccines were most frequently administered during early pregnancy and among younger women , suggesting that vaccination may occur when the woman and/or provider are unaware of the pregnancy .


Contraindicated vaccines were infrequently administered during pregnancy ; however , given that some women received contraindicated vaccines later in pregnancy , clearer recommendations and improved provider education may be needed .


Antidepressant medication ( ADM ) is efficacious in the treatment of depression , but not all patients achieve remission and fewer still achieve recovery with ADM alone .


To determine the effects of combining cognitive therapy ( CT ) with ADM vs ADM alone on remission and recovery in major depressive disorder ( MDD ) .


A total of 452 adult outpatients with chronic or recurrent MDD participated in a trial conducted in research clinics at 3 university medical centers in the United States .


The patients were randomly assigned to ADM treatment alone or CT combined with ADM treatment .


Treatment was continued for up to 42 months until recovery was achieved .


Antidepressant medication with or without CT. .


Blind evaluations of recovery with a modified version of the 17-item Hamilton Rating Scale for Depression and the Longitudinal Interval Follow-up Evaluation .


Combined treatment enhanced the rate of recovery vs treatment with ADM alone ( 72.6 % vs 62.5 % ; t451 = 2.45 ; P = .01 ; hazard ratio [ HR ] , 1.33 ; 95 % CI , 1.06-1 .68 ; number needed to treat [ NNT ] , 10 ; 95 % CI , 5-72 ) .


This effect was conditioned on interactions with severity ( t451 = 1.97 ; P = .05 ; NNT ,5 ) and chronicity ( 2 = 7.46 ; P = .02 ; NNT ,6 ) such that the advantage for combined treatment was limited to patients with severe , nonchronic MDD ( 81.3 % vs 51.7 % ; n = 146 ; t145 = 3.96 ; P = .001 ; HR , 2.34 ; 95 % CI , 1.54-3 .57 ; NNT , 3 ; 95 % CI , 2-5 ) .


Fewer patients dropped out of combined treatment vs ADM treatment alone ( 18.9 % vs 26.8 % ; t451 = -2.04 ; P = .04 ; HR , 0.66 ; 95 % CI , 0.45-0 .98 ) .


Remission rates did not differ significantly either as a main effect of treatment or as an interaction with severity or chronicity .


Patients with comorbid Axis II disorders took longer to recover than did patients without comorbid Axis II disorders regardless of the condition ( P = .01 ) .


Patients who received combined treatment reported fewer serious adverse events than did patients who received ADMs alone ( 49 vs 71 ; P = .02 ) , largely because they experienced less time in an MDD episode .


Cognitive therapy combined with ADM treatment enhances the rates of recovery from MDD relative to ADMs alone , with the effect limited to patients with severe , nonchronic depression .


clinicaltrials.gov Identifier : NCT00057577 .


Home-based rehabilitation following total knee replacement surgery can be as effective as clinic-based or in-patient rehabilitation .


The use of the Nintendo Wii has been postulated as a novel rehabilitation tool that adds an additional focus on balance and proprioception into the recovery protocol .


The aim of the proposed clinical trial is to investigate the effectiveness of this novel rehabilitation tool , used at home for three months after total knee replacement surgery and to assess any lasting improvements in functional outcome at one year .


This will be a randomised controlled trial of 128 patients undergoing primary total knee replacement .


The participants will be recruited preoperatively from three surgeons at a single centre .


There will be no change to the usual care provided until 6 weeks after the operation .


Then participants will be randomised to either the Wii-Fit group or usual rehabilitative care group .


Outcomes will be assessed preoperatively , a 6-week post surgery baseline and then at 18 weeks , 6 months and 1 year .


The primary outcome is the change in self-reported WOMAC total score from week 6 to 18 weeks .


Secondary outcomes include objective measures of strength , function and satisfaction scores .


The results of this clinical trial will be directly relevant for implementation into clinical practice .


If beneficial , this affordable technology could be used by many patients to rehabilitate at home .


Not only could it optimize the outcomes from their total knee replacement surgery but decrease the need for clinic-based or outpatient therapy for the majority .


( ACTRN12611000291987 ) .


To observe the changes of plasminogen activator inhibitor-1 and D-dimer during continuous blood purification ( CBP ) and related factors .


Sixteen patients who were diagnosed with multiple organ dysfunction syndrome ( MODS ) were randomly divided into 2 groups : 8 patients received standard continuous blood purification with heparin anticoagulation , and the other 8 received CBP without anticoagulation .


Ten normal blood samples were collected from healthy volunteers as controls .


All patients underwent CBP for 8 h. Blood was taken from those patients at 0 , 15 , 60 , 120 and 480 min during the CBP .


Plasma plasminogen activator inhibitor-1 , D-dimer and serum TNF - and IL-1 were measured by ELISA .


Plasma levels of PAI-1 and D-dimer were increased significantly compared with those in the control group ( P < 0.05 ) .


Plasma level of PAI-1 was reduced ( P < 0.05 ) and D-dimer was increased ( P < 0.05 ) after the CBP .


The level of plasma PAI-1 in the heparin group was significant reduced compared with the group of CBP without anticoagulation ( P < 0.05 ) .


There was negative correlation between the level of PAI-1 and the dosage of heparin used during a CBP session in the heparin group ( r = -0.746 , P < 0.001 ) .


The level of PAI-1 and D-dimer is higher in patients with MODS than that in the normal controls .


After the CBP treatment , there is significant decrease in PAI-1 and increase in D-dimer in both groups .


Heparin used during CBP can reduce PAI-1 which intensifies its function of anticoagulation .


In the TRACER trial , vorapaxar , a protease-activated receptor-1 antagonist , plus standard care in non-ST-segment elevation acute coronary syndrome ( NSTE ACS ) patients did not significantly reduce the primary composite end point but reduced a key secondary end point and significantly increased bleeding .


History of peripheral artery disease ( PAD ) was a risk-enrichment inclusion criterion .


We investigated the efficacy and safety of vorapaxar in NSTE ACS patients with documented PAD .


TRACER was a double-blind , randomized trial comparing vorapaxar with placebo in 12,944 patients with NSTE ACS .


In total , 936 ( 7.2 % ) patients had a history of PAD .