The findings of this trial can provide policy makers with evidence regarding the effectiveness and cost-effectiveness of structured psychological interventions for maternal depression delivered by appropriately trained and supervised non-specialist CHWs in sub-Saharan Africa .


Clinical Trials ( ClinicalTrials.gov ) : NCT01977326 , registered on 24/10/2013 ; Pan African Clinical Trials Registry ( http://www.pactr.org ) : PACTR201403000676264 , registered on 11/10/2013 .


We aimed to explore the specific effects of mindfulness-based stress reduction ( MBSR ) for urban youth by comparing it with an active control program , designed to control for time , positive peer-group experience , and positive adult instructor .


Patients between the ages of 13-21 years who received primary pediatric care at our urban outpatient clinic were eligible for study participation .


Those who were interested were consented and randomly assigned to an eight-week program of MBSR or Healthy Topics ( HT ) , a health education curriculum .


To increase sensitivity to outcomes of interest , mixed methods were used to assess psychological symptoms , coping , and program experience .


Analysis of variance and regression modeling were used ; interviews were audio-taped , transcribed , and coded for key themes .


A total of 43 ( 26 MBSR , 17 HT ) youths attended one or more sessions , of whom 35 [ 20 MBSR ( 77 % ) , 15 HT ( 88 % ) ] attended the majority of the sessions and were considered completers .


Program completers were African American , 80 % female , with average age of 15.0 years .


Statistical analysis of survey data did not identify significant post-program differences between groups .


Qualitative data show comparable positive experiences in both programs , but specific differences related to MBSR participants use of mindfulness techniques to calm down and avoid conflicts , as well as descriptions of internal processes and self-regulation .


Compared with an active control program , MBSR did not result in statistically significant differences in self-reported survey outcomes of interest but was associated with qualitative outcomes of increased calm , conflict avoidance , self-awareness , and self-regulation for urban youths .


Importantly , based on qualitative results , the HT program functioned as an effective active control for MBSR in this sample , facilitating a more rigorous methodological approach to MBSR research in this population .


We believe the promising effects elucidated in the qualitative data have the potential for positive affective and behavioral outcomes .


Plyometric exercise has been recommended to prevent lower limb injury , but its feasibility in and effects on those with functional ankle instability ( FAI ) are unclear .


To investigate the effect of integrated plyometric and balance training in participants with FAI during a single-legged drop landing and single-legged standing position .


Randomized controlled clinical trial .


University motion-analysis laboratory .


Thirty athletes with FAI were divided into 3 groups : plyometric group ( 8 men , 2 women , age = 23.20 2.82 years ; 10 unstable ankles ) , plyometric-balance ( integrated ) - training group ( 8 men , 2 women , age = 23.80 4.13 years ; 10 unstable ankles ) , and control group ( 7 men , 3 women , age = 23.50 3.00 years ; 10 unstable ankles ) .


A 6-week plyometric-training program versus a 6-week integrated-training program .


Postural sway during single-legged standing with eyes open and closed was measured before and after training .


Kinematic data were recorded during medial and lateral single-legged drop landings after a 5-second single-legged stance .


Reduced postural sway in the medial-lateral direction and reduced sway area occurred in the plyometric - and integrated-training groups .


Generally , the plyometric training and integrated training increased the maximum angles at the hip and knee in the sagittal plane , reduced the maximum angles at the hip and ankle in the frontal and transverse planes in the lateral drop landing , and reduced the time to stabilization for knee flexion in the medial drop landing .


After 6 weeks of plyometric training or integrated training , individuals with FAI used a softer landing strategy during drop landings and decreased their postural sway during the single-legged stance .


Plyometric training improved static and dynamic postural control and should be incorporated into rehabilitation programs for those with FAI .


The lack of national oral health policy and organized school dental health programs in the country call for affordable , accessible , and sustainable strategies .


The objective was to compare the oral hygiene , plaque , gingival , and dental caries status among rural children receiving dental health education by qualified dentists and school teachers with and without supply of oral hygiene aids .


This interventional study was conducted among 15-year-old children selected randomly from four schools in Nalgonda district between September 2009 and February 2010 .


Schools were divided into four different intervention groups .


The intervention groups varied in the form of intervention provider and frequency of intervention one of which being the control group .


The oral hygiene , plaque , gingival , and dental caries status was assessed at baseline and 6 months following the intervention .


SPSS 16 was used for analysis .


The preintervention and postintervention comparison within each group revealed a substantial reduction in mean oral hygiene index-simplified ( OHI-S ) , plaque index ( PI ) , and gingival index ( GI ) at postintervention compared to baseline in group 4 ( 1.26 , 0.87 , and 0.74 , respectively ) followed by group 3 ( 0.14 , 0.37 , and 0.12 , respectively ) .


The OHI-S , PI , and GI scores increased in group 1 ( 0.66 , 0.37 , and 0.34 , respectively ) and group 2 ( 0.25 , 0.19 , and 0.14 , respectively ) .


Mean decayed , missing filled surfaces score between the groups was not statistically significant at baseline and postintervention .


The dramatic reductions in the OHI-S , PI , and GI scores in the group supplied with oral hygiene aids call for supplying low cost fluoridated toothpastes along with toothbrushes through the school systems in rural areas .


Although most mirror therapy studies have shown improved motor performance in stroke patients , the optimal mirror training protocol still remains unclear .


To study the relative contribution of a mirror in training a reaching task and of unilateral and bimanual training with a mirror .


A total of 93 stroke patients at least 6 months poststroke were instructed to perform a reaching task as fast and as fluently as possible .


They performed 70 practice trials after being randomly allocated to 1 of 5 experimental groups : training with ( 1 ) the paretic arm with direct view ( Paretic-No Mirror ) , ( 2 ) the nonparetic arm with direct view ( Nonparetic-No Mirror ) , ( 3 ) the nonparetic arm with mirror reflection ( Nonparetic Mirror ) , ( 4 ) both sides and with a nontransparent screen preventing visual control of paretic side ( Bilateral-Screen ) , and ( 5 ) both sides with mirror reflection of the nonparetic arm ( Bilateral-Mirror ) .


As baseline and follow-up , patients performed 6 trials using only their paretic side .


Primary outcome measure was the movement time .


We found the largest intervention effect in the Paretic-No Mirror condition .


However , the Nonparetic-Mirror condition was not significantly different from the Paretic-No Mirror condition , while the Unaffected-No Mirror condition had significantly less improvement than the Paretic-No Mirror condition .


In addition , movement time improved significantly less in the bimanual conditions and there was no difference between both bimanual conditions or between both mirror conditions .


The present study confirms that using a mirror reflection can facilitate motor learning .


In this task , bimanual movement using mirror training was less effective than unilateral training .


To examine the relationships between parental patterns regarding child feeding and child body mass index ( BMI ) percentile in Latino parent-preschooler dyads participating in a clinical trial .


This secondary analysis examined data collected during a randomized clinical trial of a culturally tailored healthy lifestyle intervention focused on childhood obesity prevention , Salud Con La Familia .


We analyzed 77 Latino parent-child dyads who completed baseline and 3-month follow-up data collection , assessing associations between preschool child BMI percentile and parental response to the Child Feeding Questionnaire ( CFQ ) over time .


Higher child BMI was related to higher parental CFQ concern scores ( r = 0.41 , p < .001 ) .


A general inverse association between child BMI percentile and parental responsibility was also observed ( r = -0.23 , p = .040 ) .


Over the 3-month period , no statistically significant associations between changes in the CFQ subscale scores and changes in child BMI percentile were identified .


Child BMI percentile consistent with overweight/obese is associated with parental concern about child weight and child BMI percentile consistent with normal weight is associated with perceived responsibility for feeding .


Emphasizing parental responsibility to help children to develop healthy eating habits could be an important aspect of interventions aimed at both preventing and reducing pediatric obesity for Latino preschoolers .


A randomized , crossover , double-blinded placebo-controlled and non-blinded active drug-controlled , comparative clinical trial was conducted to evaluate the efficacy and safety of sublingual fentanyl tablet .


Subjects were patients treated with strong opioids at fixed intervals for chronic cancer pain and with oral morphine as rescue medication for breakthrough pain .


Sublingual fentanyl was administered at doses that were 1/25th ( high dose ) and 1/50th ( low dose ) of the dose of rescue morphine and was compared with placebo and oral morphine .


The primary endpoint was pain intensity difference at 30 min after administration .


( Clinical Trials Government ; NCT00684632 ) .


Fifty-one patients were enrolled in the investigation .


Their mean pain intensity in visual analog scale before rescue medication prior to the investigation was 60.96 ( 16.44 , standard deviation ) mm .


Compared with placebo , the low and high doses of sublingual fentanyl showed significant analgesic effects ( least squares mean difference , 4.54 and 8.49 mm ; P = 0.014 , P < 0.001 , respectively ) .


Adverse reactions were observed in 17.6 % , the most common being constipation , nausea and somnolence .


The incidence of adverse reactions during the high-dose administration period was higher than that during the low-dose and active control drug administration periods .


Patients treated with strong opioid analgesics at fixed intervals for chronic cancer pain and with oral morphine at doses up to 20 mg as rescue medication were investigated .


The doses of sublingual fentanyl to treat breakthrough pain were determined from rescue morphine doses by use of conversion ratios .


In these patients , administration of sublingual fentanyl at doses determined by a conversion ratio of 1/50 was effective and safe .


Further studies are needed to validate the use of this conversion method .


NSABP C-06 demonstrated the non-inferiority of oral adjuvant uracil and tegafur plus leucovorin ( UFT/LV ) to weekly fluorouracil and folinate ( 5-FU/LV ) with respect to disease-free survival ( DFS ) for stage II/III colon cancer .


This is the first report of JCOG0205 , which compared UFT/LV to standard 5-FU/levofolinate ( l-LV ) for stage III colorectal cancer patients who have undergone Japanese D2/D3 lymph node dissection .


Patients were randomised to three courses of 5-FU/l-LV ( 5-FU 500 mg/m ( 2 ) , l-LV 250 mg/m ( 2 ) on days 1 , 8 , 15 , 22 , 29 , 36 every 8 weeks ) or five courses of UFT/LV ( UFT 300 mg m ( -2 ) day ( -1 ) , LV 75 mg/day on days 1-28 every 5 weeks ) .


The primary end-point was DFS .


The sample size was 1100 determined with one-sided alpha of 0.05 , power of 0.78 and non-inferiority margin of hazard ratio of 1.27 .


This trial is registered with UMIN-CTR ( C000000193 ) .


Between February 2003 and November 2006 , 1,101 patients ( 1092 eligible patients ) were randomised to 5-FU/l-LV ( n = 550 ) or UFT/LV ( n = 551 ) .


Median age : 61 years , colon/rectum : 67 % / 33 % , number of positive nodes 3 / > 3 : 73 % / 27 % , stage IIIa/IIIb : 75 % / 25 % .


The hazard ratio of DFS was 1.02 ( 91.3 % confidence interval , 0.84-1 .23 ) , demonstrating the non-inferiority of UFT/LV ( P = 0.0236 ) .


Five-year overall survival ( 87.5 % ) was higher than that in NSABP C-06 ( 69.6 % ) .


Grade 3/4 toxicities were 8.4 % neutropenia in 5-FU/l-LV and 8.7 % alanine aminotransferase elevation in UFT/LV , respectively .


The incidences of diarrhoea ( 9.6 % versus 8.5 % ) and anorexia ( 4.0 % versus 3.7 % ) were similar between the two arms .


No treatment-related deaths were reported .


Adjuvant UFT/LV is non-inferior to standard 5-FU/l-LV with respect to DFS .


UFT/LV should be an oral treatment option for patients with stage III colon cancer who have undergone Japanese D2/D3 lymph node dissection .


As no human data exist , we aimed to determine the relation between ambient temperature and volume of perihematomal ` cerebral ' edema in acute spontaneous intracerebral haemorrhage ( ICH ) among Chinese participants of the pilot phase , Intensive Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial ( INTERACT1 ) .


INTERACT1 was a multicenter , open , blind outcome assessed , randomized controlled trial of intensive ( systolic target < 140mmHg ) vs. guideline-recommended ( systolic target < 180mmHg ) blood pressure ( BP ) lowering in 404 patients with acute ICH .


Data on ambient temperature ( mean , minimum , maximum , and range ) on the day of each participant 's ICH obtained from China Meteorological Data Sharing Service System were linked to other data including edema volumes .


Multivariable regression analyses were performed to evaluate association between ambient temperature and edema volumes .


A generalized linear regression model with a generalized estimating equations approach ( GEE ) was used to assess any association of ambient temperature and change in edema volume over 72h .


A total of 250 of all 384 Chinese participants had complete data that showed positive associations between ambient temperature ( mean and minimum temperatures ) and edema volumes at each time point over 72h after hospital admission ( all P < 005 ) .


All temperature parameters except diurnal temperature range were positively associated with edema volume after adjustment for confounding variables ( all P < 002 ) .


An apparent positive association exists between ambient temperature and perihematomal edema volume in acute spontaneous ICH .


To gain further evidence on the efficacy , safety and tolerability of tadalafil 5mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia .


Japanese and Korean men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia were randomized to once-daily tadalafil 5mg ( n = 306 ) or placebo ( n = 304 ) for 12 weeks .


A significantly greater improvement ( P < 0.001 ) in total International Prostate Symptom Score for the change from baseline ( week 0 ) to study end-point ( week 12 ) was observed for tadalafil ( -6.0 ) versus placebo ( -4.5 ) .


Significantly greater improvements ( P < 0.01 ) in total International Prostate Symptom Score for the change from baseline to weeks 4 and 8 were observed for tadalafil versus placebo .


Significantly greater improvements ( P < 0.05 ) in International Prostate Symptom Score voiding and storage subscores , and International Prostate Symptom Score Quality of Life Index were observed for the change from baseline to end-point for tadalafil versus placebo .


Significantly greater improvements ( P < 0.001 ) in urinary symptoms were observed for tadalafil versus placebo for both Patient and Clinician Global Impressions of Improvement .


No new safety concerns were identified .


These findings confirm the efficacy and safety profile of tadalafil 5mg once-daily in Asian men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia .


This was a flexible-dosed study to evaluate the efficacy and safety of duloxetine 30-120mg once daily in the treatment of generalized anxiety disorder ( GAD ) in older adult patients .


Patients with GAD , who were at least 65years of age , were randomly assigned to double-blind treatment with either duloxetine ( N = 151 ) or placebo ( N = 140 ) .


The primary efficacy measure was the Hamilton Anxiety Rating Scale ( HAM-A ) total score , and the primary endpoint was at week 10 .


Global functioning was assessed by the Sheehan Disability Scale ( SDS ) .


Safety and tolerability was assessed by the occurrence of treatment-emergent adverse events , serious adverse events , laboratory analyses , and vital signs .


Analyses were conducted on an intent-to-treat basis .


The overall baseline mean HAM-A total score was 24 , and SDS global score was 14 .


Completion rates were 75 % for placebo and 76 % for duloxetine .


At week 10 , duloxetine was superior to placebo on mean changes from baseline in HAM-A total scores ( -15.9 vs. -11.7 , p < 0.001 ) and in SDS global scores ( -8.6 vs. -5.4 , p < 0.001 ) .


Treatment-emergent adverse events occurred in 5 % of duloxetine-treated patients and twice the rate than with placebo including constipation ( 9 % vs. 4 % , p = 0.06 ) , dry mouth ( 7 % vs. 1 % , p = 0.02 ) , and somnolence ( 6 % vs. 2 % , p = 0.14 ) .


Duloxetine treatment was efficacious in the improvement of anxiety and functioning in older adult patients with GAD , and the safety profile was consistent with previous GAD studies .


Because of ongoing controversy , renal and vital outcomes are compared between systemically administered unfractionated heparin and regional anticoagulation with citrate-buffered replacement solution in predilution mode , during continuous venovenous hemofiltration ( CVVH ) in critically ill patients with acute kidney injury ( AKI ) .


In this multi-center randomized controlled trial , patients admitted to the intensive care unit requiring CVVH and meeting inclusion criteria , were randomly assigned to citrate or heparin .


Primary endpoints were mortality and renal outcome in intention-to-treat analysis .


Secondary endpoints were safety and efficacy .


Safety was defined as absence of any adverse event necessitating discontinuation of the assigned anticoagulant .


For efficacy , among other parameters , survival times of the first hemofilter were studied .


Of the 139 patients enrolled , 66 were randomized to citrate and 73 to heparin .


Mortality rates at 28 and 90 days did not differ between groups : 22/66 ( 33 % ) of citrate-treated patients died versus 25/72 ( 35 % ) of heparin-treated patients at 28 days , and 27/65 ( 42 % ) of citrate-treated patients died versus 29/69 ( 42 % ) of heparin-treated patients at 90 days ( P = 1.00 for both ) .


Renal outcome , i.e. independency of renal replacement therapy 28 days after initiation of CVVH in surviving patients , did not differ between groups : 29/43 ( 67 % ) in the citrate-treated patients versus 33/47 ( 70 % ) in heparin-treated patients ( P = 0.82 ) .


Heparin was discontinued in 24/73 ( 33 % ) of patients whereas citrate was discontinued in 5/66 ( 8 % ) of patients ( P < 0.001 ) .


Filter survival times were superior for citrate ( median 46 versus 32 hours , P = 0.02 ) , as were the number of filters used ( P = 0.002 ) and the off time within 72 hours ( P = 0.002 ) .


The costs during the first 72 hours of prescribed CVVH were lower in citrate-based CVVH .


Renal outcome and patient mortality were similar for citrate and heparin anticoagulation during CVVH in the critically ill patient with AKI .


However , citrate was superior in terms of safety , efficacy and costs .


Clinicaltrials.gov NCT00209378 .


Registered 13th September 2005 .


The aim of the present study was to evaluate the effectiveness of a worksite mindfulness-related multi-component health promotion intervention on work engagement , mental health , need for recovery and mindfulness .


In a randomized controlled trial design , 257 workers of two research institutes participated .


The intervention group ( n = 129 ) received a targeted mindfulness-related training , followed by e-coaching .


The total duration of the intervention was 6 months .


Data on work engagement , mental health , need for recovery and mindfulness were collected using questionnaires at baseline and after 6 and 12 months follow-up .


Effects were analyzed using linear mixed effect models .


There were no significant differences in work engagement , mental health , need for recovery and mindfulness between the intervention and control group after either 6 - or 12-months follow-up .


Additional analyses in mindfulness-related training compliance subgroups ( high and low compliance versus the control group as a reference ) and subgroups based on baseline work engagement scores showed no significant differences either .


This study did not show an effect of this worksite mindfulness-related multi-component health promotion intervention on work engagement , mental health , need for recovery and mindfulness after 6 and 12 months .


Netherlands Trial Register NTR2199 .


To compare maximal evoked torque , discomfort , and fatigue-related outcomes between multipath neuromuscular electrical stimulation ( NMES ) and conventional NMES of the quadriceps muscle in patients with total knee arthroplasty ( TKA ) .


Randomized , single-blind , crossover study with 2 experimental sessions ( multipath NMES , conventional NMES ) .


Research laboratory .


Patients ( N = 20 ; mean age , 68y ) 6 to 12 months after TKA surgery .


None .


We quantified NMES-evoked knee extension torque at the maximally tolerated current intensity , self-reported discomfort , and fatigue induced by NMES intermittent contractions in both conditions .


Compared with conventional NMES , multipath NMES resulted in higher evoked torque ( 33 % , P < .001 ) , lower discomfort scores ( -39 % , P < .001 ) , and less quadriceps muscle fatigue ( P = .034 ) .


The use of multiple current pathways distributed to large electrodes allowed multipath NMES to generate stronger contractions and reduce discomfort and fatigue compared with conventional NMES .


Therefore , multipath NMES has the potential to be more effective than conventional NMES .


The aim was to evaluate the impact of the ` Healthy Dads , Healthy Kids ' programme on fathers ' and mothers ' activity - and diet-related parenting practices .


Overweight/obese fathers ( n = 87 ) and their primary school-aged children ( 56 % boys ) were randomized to either ( i ) 7-week programme ( n = 45 ) or ( ii ) control group ( n = 42 ) .


The programme involved four sessions for fathers only and three for fathers/children .


Mothers were not directly involved .


Parenting practices of both fathers and mothers were measured using the parenting strategies for eating and activity scale at baseline and 14-week follow-up .


Intention-to-treat analysis using linear mixed models revealed significant group-by-time effects for fathers ' limit setting ( P = 0.048 , d = 0.36 ) and reinforcement for multiple lifestyle behaviours ( P = 0.001 , d = 0.79 ) .


No significant intervention effects were found for fathers ' control , monitoring , discipline or mothers ' parenting practices ( P > 0.05 ) .


The Healthy Dads , Healthy Kids programme had a positive impact on some parenting practices for fathers but not mothers .


The Pilates method has been widely used to treat patients with chronic low back pain .


Pilates exercises can be performed in 2 ways : by using specific equipment or without it ( also known as mat Pilates ) .


There are no studies , however , that have compared the effectiveness of mat Pilates with that of equipment-based Pilates .


The aim of this study was to compare the effectiveness of mat Pilates and equipment-based Pilates in patients with chronic nonspecific low back pain .


A 2-arm randomized controlled trial with a blinded assessor was conducted .


The study was conducted at a private physical therapy clinic in Brazil .


Eighty-six patients with chronic nonspecific low back pain participated .


The patients were randomly allocated to 1 of 2 groups : a mat Pilates group ( n = 43 ) and an equipment-based Pilates group ( n = 43 ) .


The participants in both groups attended 12 Pilates sessions over a period of 6 weeks .


The primary outcomes were pain intensity and disability .


The secondary outcomes were global perceived effect , patient 's specific disability , and kinesiophobia .


A blinded assessor evaluated the outcomes at baseline and 6 weeks and 6 months after randomization .


After 6 months , there was a statistically significant difference for disability ( mean difference = 3.0 points , 95 % confidence interval [ CI ] = 0.6 to 5.4 ) , specific disability ( mean difference = -1.1 points , 95 % CI = -2.0 to -0.1 ) , and kinesiophobia ( mean difference = 4.9 points , 95 % CI = 1.6 to 8.2 ) in favor of equipment-based Pilates .


No differences were found for the remaining outcomes .


Equipment-based Pilates was superior to mat Pilates in the 6-month follow-up for the outcomes of disability and kinesiophobia .


These benefits were not observed for pain intensity and global perceived effect in patients with chronic nonspecific low back pain .


To assess the effect of a weight-loss program on improving iron status in overweight and obese school-aged children .


The data were analyzed in overweight and obese children ( 7-11 years of age ; 114 girls and 212boys ) with body mass index-for-age z-scores ( BAZ ) > 1 from a weight-loss program .


Schools were randomly divided into 2 groups : intervention and control .


Children in the intervention group underwent a 1-year , nutrition-based comprehensive intervention weight-loss program .


Anthropometric , dietary intake , and physical activity data were collected at baseline and follow-up ( 1 year ) .


Iron status and inflammatory markers were assessed within a month .


In the intervention group , BAZ decreased more than that in the control group ( -0.4 0.7 vs -0.1 0.6 , P < .0001 ) ; and iron profiles and inflammation status were improved at follow-up .


In multivariable linear regression models , a greater decrease of BAZ and inflammation factors predicted a better improvement of iron status .


After adjustment of BAZ , C-reactive protein was significantly associated with serum ferritin ( : 1.89 ; 95 % CI , 0.70-3 .09 ; P = .002 ) and soluble transferrin receptor ( : 0.88 ; 95 % CI , 0.16-0 .59 ; P = .017 ) ; interleukin-6 was significantly associated with serum ferritin ( : 1.22 ; 95 % CI , 0.64-1 .79 ; P < .0001 ) .


Iron status and inflammation were improved by weight reduction .


The improvement in inflammatory markers during weight reduction was independently associated with improvements of iron status .


To evaluate the efficiency and safety of two treatment regimens using ramipril or losartan in combination with hydrochlorothiazide ( HCT ) and amlodipine in grade 1-2 arterial hypertension ( AH ) .


The prospective , international , multicenter , randomized , open-label , controlled trial with parallel groups included 347 AH patients in Russia ( n = 166 ) , Croatia , and Ukraine .


The follow-up was 12 weeks in patients not receiving antihypertensive therapy ( AHT ) and 13 weeks in those who had previously received AHT with regard to a washout period .


The basis for two treatment regimens was ramipril or losartan .


If no target blood pressure ( BP ) was achieved , amlodipine or HCT was added at week 4 and a third antihypertensive drug ( AHD ) was used 8 weeks later .


At the inclusion , clinical BP was 157.64 / 95.5 mm Hg in 332 ( 61 % ) AH patients aged 55.9 + / - 11 years .


At week 4 of monotherapy with ramipil 5 mg or losartan 50 mg , BP was reduced to 141.9 / 87.4 mm Hg .


Addition of a second AHD further lowered BP to 131.8 / 81.9 mm Hg ( to 127.6 / 79.7 at 12 weeks of treatment ; p < 0.001 ) .


After 4 weeks of treatment with ramipril 5 mg or losartan 50 mg , 35 % of the patients achieved target BP .


At weeks 8 and 12 , double or triple AHT increased the number of patients achieving the target level up to 75 and 94 % , respectively .


When losartan was used as monotherapy , about one third of the patients achieved target BP ; 20 and 22 % of the patients required the addition of a second AHD ( HCT and amlodipine , respectively ) .


Only 10 % of the patients needed to take a combination of three AHDs .


Nearly one third of the patients achieved target BP during monotherapy with losartan or ramipril .


Double AHT involving ramipril or losartan in combination with the diuretic or amlodipine was used in 18 and 20 % and in 22 and 24 % of the patients , respectively .


28 and 19 % of the patients received triple therapy including ramipril or losartan , amlodipine , and HCT .


The most common adverse reactions were dizziness ( 2.4 % ) , fatigue ( 1.8 % ) , and coughing ( 1.2 % ) .


In the patients with grades 1-2 AH , the treatment regimens using basic therapy with ramipril or losartan proved to be highly effective and allowed target BP to be achieved in 94 % of cases .


Both treatment regimens were comparable in view of safety ; slight side effects occurred rarely ( in less than 2.5 % of the patients ) and required that the treatment should not be discontinued .


To evaluate the efficacy of diode laser ablation of prostate for treating lower urinary tract symptoms ( LUTS ) in patients with locally advanced prostate cancer and comparing results with palliative transurethral resection of prostate ( pTURP ) .


Thirty-six known cases of locally advanced prostate cancer with a maximum urinary flow rate ( Qmax ) of 12 mL per second or less and an International Prostate Symptom Score ( IPSS ) of 20 or more were included in this study .


Patients were randomized into two groups .


The first group underwent pTURP and for the second group diode laser ablation of prostate was done .


In 6 months post-operative follow up , patients were evaluated for IPSS , post void residual ( PVR ) urine volume , Qmax and possible complications such as urethral stricture or urinary incontinence .


Postoperatively , mean IPSS was 11.1 4.1 in TURP group and 11.7 3.6 in laser group ( P = .64 ) .


Mean PVR was 18.4 3.5 mL in TURP group and 17.7 6.3 mL in laser group ( P = .68 ) .


Mean Qmax in TURP and laser groups were measured 20.1 4.5 mL/s and 19.4 2.6 mL/s , respectively ( P = .57 ) .


While there was a significant improvement in IPSS and Qmax and PVR in both groups , statistical analysis did not show any significant difference postoperatively between pTURP and laser groups .


Diode laser ablation of prostate and pTURP , both improved significantly IPSS , PVR and Qmax .


But hospital stay and post-operative catheterization time was less in laser group .


Postoperative nausea and vomiting ( PONV ) occur frequently after laparoscopic bariatric surgery .


The combination of haloperidol , dexamethasone , and ondansetron may reduce these undesirable events .


The aim of this study was to evaluate the intensity of nausea and pain , the number of vomiting episodes , and morphine consumption in postoperative ( PO ) obese patients undergoing laparoscopic sleeve gastrectomy ( LSG ) .


A clinical , randomized , controlled , double-blind study conducted with 90 patients with body mass index 35 kg.cm-2 .


Patients were divided into three groups of 30 individuals to receive ondansetron 8 mg ( Group O ) ; ondansetron 8 mg and dexamethasone 8 mg ( Group OD ) ; and ondansetron 8 mg , dexamethasone 8 mg , and haloperidol 2 mg ( Group HDO ) .


We evaluated the intensity of nausea and pain using the verbal numeric scale , cumulative number of vomiting episodes , and morphine consumption in the period of 0-2 , 2-12 , 12-24 , and 24-36 hours postoperatively .


Nausea intensity was lower in Group HDO compared to Group O ( p = 0.001 ) , pain intensity was lower in Group HDO compared to Group O ( p = 0.046 ) , and morphine consumption was lower in Group HDO compared to Group O ( p = 0.037 ) .


There was no difference between groups regarding the number of vomiting episodes ( p = 0.052 ) .


The combination of haloperidol , ondansetron , and dexamethasone reduced nausea and pain intensity and morphine consumption in postoperative obese patients undergoing LSG .


This study compared the biocompatibility and comfort of 4 lens care solutions currently marketed in France .


This was a randomized , interventional , double-masked , single-center crossover study assessing balafilcon A silicone hydrogel contact lenses , bilaterally , straight from the blister pack solution ( control ) and pre-soaked in the following lens care solutions : Regard ( ) ( containing sodium chlorite ) , ReNu ( ) ( containing a PHMB [ polyhexamethylene biguanide ] derivative ) , CyClean and MeniCare Soft ( both containing PHMB ) .


Subjects were randomized to the order of test solution use .


For each of the 5 solutions tested , subjects attended a baseline/lens dispensing visit and an intervention visit 2h later .


At both visits , evaluation included slit-lamp examination , corrected-distance visual acuity , corneal staining , and subject-assessed photophobia , ocular comfort , and ocular redness .


Thirty subjects were enrolled and 28 were evaluable .


Corneal staining severity was significantly worse than baseline after 2h of wearing lenses soaked in CyClean , MeniCare , or ReNu ( P0 .001 ) .


The MeniCare group alone demonstrated a significant improvement in ocular comfort after 2h of lens wear ( P = 0.02 ) .


No group demonstrated significant changes in ocular redness or photophobia .


Corrected-distance visual acuity was similar between baseline and intervention visits for each test solution .


No adverse events were reported during the study .


Silicone hydrogel contact lenses presoaked in lens solutions containing PHMB or a PHMB derivative produced an increase in corneal staining after 2h of lens wear .


The higher levels of corneal staining in the 2 solutions did not correlate with increased discomfort within this 2-h timeframe .


The purpose of this study was to examine the relationship between fatigue and clinical outcomes , using dyspnea as a comparator , in patients with left ventricular ejection fraction ( LVEF ) 35 % enrolled in the CORONA ( Controlled Rosuvastatin Multinational Trial in Heart Failure ) study .


Although fatigue is a common symptom in heart failure ( HF ) , little is known about its association with prognosis .


At baseline in CORONA , fatigue `` during the past few days '' was measured using a 5-point exertion scale ( 0 = none , 1 = heavy exertion , 2 = moderate exertion , 3 = slight exertion , 4 = rest ) ; a 4-point scale was used for dyspnea ( 1 to 4 as for fatigue ) .


Patients were grouped into 3 categories : a fatigue score 0 to 1 ( n = 535 ) , fatigue score 2 ( n = 1,632 ) , and fatigue score 3 to 4 ( n = 1,663 ) ; and a dyspnea score of 1 ( n = 292 ) , dyspnea score of 2 ( n = 1,695 ) , and dyspnea score of 3 to 4 ( n = 1,843 ) .


The association between fatigue and dyspnea and the composite outcome of cardiovascular ( CV ) death or HF hospital stay and each component separately was examined using Kaplan-Meier analysis and Cox proportional-hazard models .


We also examined all-cause mortality .


In univariate analyses , symptom severity was associated with a higher risk of CV death or HF hospital stay ( fatigue : group 3 , 49 % [ n = 810 ] , vs. group 1 , 30 % [ n = 160 ] ; dyspnea : group 3 , 50 % [ n = 918 ] , vs. group 1 , 28 % [ n = 82 ] ) and all-cause mortality ( fatigue : group 3 , 38 % [ n = 623 ] , vs. group 1 , 24 % [ n = 130 ] ; dyspnea : group 3 , 38 % [ n = 697 ] , vs. group 1 , 23 % [ n = 66 ] , log-rank p < 0.0001 for all ) .


After adjusting for other prognostic variables , including LVEF , New York Heart Association class , and N-terminal pro-B-type natriuretic peptide level , worse fatigue remained associated with higher risk of HF hospital stay but not mortality ( worse dyspnea remained associated with a higher risk of both ) .


An increase in fatigue ( or dyspnea ) between baseline and 6 months was also associated with worse outcomes .


In HF , greater fatigue is associated with worse clinical outcomes .


Closer attention should be paid to this symptom in clinical practice , with more done to standardize its measurement and understand its origins , with a view to improving treatment .


We have recently described an increased lymphocytic infiltration rate in breast carcinoma tissue is a significant response predictor for anthracycline/taxane-based neoadjuvant chemotherapy ( NACT ) .


The aim of this study was to prospectively validate the tumor-associated lymphocyte infiltrate as predictive marker for response to anthracycline/taxane-based NACT .


The immunological infiltrate was prospectively evaluated in a total of 313 core biopsies from HER2 negative patients of the multicenter PREDICT study , a substudy of the neoadjuvant GeparQuinto study .


Intratumoral lymphocytes ( iTuLy ) , stromal lymphocytes ( strLy ) as well as lymphocyte-predominant breast cancer ( LPBC ) were evaluated by histopathological assessment .


Pathological complete response ( pCR ) rates were analyzed and compared between the defined subgroups using the exact test of Fisher .


Patients with lymphocyte-predominant breast cancer ( LPBC ) had a significantly increased pCR rate of 36.6 % , compared to non-LPBC patients ( 14.3 % , p < 0.001 ) .


LPBC and stromal lymphocytes were significantly independent predictors for pCR in multivariate analysis ( LPBC : OR 2.7 , p = 0.003 , strLy : OR 1.2 , p = 0.01 ) .


The amount of intratumoral lymphocytes was significantly predictive for pCR in univariate ( OR 1.2 , p = 0.01 ) but not in multivariate logistic regression analysis ( OR 1.2 , p = 0.11 ) .


Confirming previous investigations of our group , we have prospectively validated in an independent cohort that an increased immunological infiltrate in breast tumor tissue is predictive for response to anthracycline/taxane-based NACT .


Patients with LPBC and increased stromal lymphocyte infiltration have significantly increased pCR rates .


The lymphocytic infiltrate is a promising additional parameter for histopathological evaluation of breast cancer core biopsies .


To formulate a comprehensive treatment program for rheumatoid arthritis arthralgia by clinical observing the efficacy of Xiaoyan Zhitong Paste ( XZP ) .


Adopted was stratified , block randomized , double-blinded , placebo parallel controlled method .


Subjects were assigned to the treatment group and the placebo group .


Those in the treatment group were treated by external application of XZP , one to two pastes each time , covering the painful area , exchange once per 24 h , with one-day interval during a 7-day consecutive medication , two 7-days of treatment consisting of one therapeutic course .


XZP placebos were applied for those in the placebo group in the same medication way .


Joint pain and VAS were taken as main indices for observing the clinical efficacy of XZP .


The improvement of the analgesic effect and the Chinese medical syndrome efficacy of XZP were superior to that of the placebo .


XZP showed obvious effect in treating rheumatoid arthritis arthralgia with no obvious adverse reaction .


A patient-centered collaborative care program for depression and uncontrolled diabetes and/or coronary heart disease ( CHD ) demonstrated improved clinical outcomes relative to usual care .


We report clinically stratified analyses of patient outcomes to inform the duration and targeting of care management services for complex patients with multimorbidity .


A 12-month randomized controlled trial of a multimorbidity collaborative care program followed patients at 6 , 12 , 18 , and 24 months for diabetes ( glycated hemoglobin [ A1C ] ) , blood pressure ( systolic ; SBP ) , low-density lipoprotein ( LDL ) cholesterol , and depression ( Symptoms Check List-20 score ) .


Depressed patients with less favorable medical control ( Patient Health Questionnaire-9 score > 10 , A1C > 8.0 % , SBP > 140 mm Hg , and LDL cholesterol > 120 mg/dL ) were compared with depressed patients with more favorable medical control to describe differential intervention benefits over time .


In contrast to patients with more favorable baseline control , patients with depression and unfavorable control of A1C , SBP , and LDL at baseline showed improved outcomes as early as the 6-month follow-up assessment .


Clinical benefits in the intervention group were largely sustained over the 24-month follow-up , except for some deterioration of glycemic control in intervention patients and trends toward improvement among controls over time .


Among patients with depression and more favorable medical control at baseline , there were minimal between-group differences in medical disease outcomes .


Clinical benefits of a multimorbidity collaborative care management program occurred early , and were only found among patients with poor control of baseline diabetes and CHD risk factors .


Targeting may maximize reach and improve affordability of complex care management .


Recent data suggest that P-glycoprotein may be involved in cellular transport of lacosamide .


To investigate potential drug-drug interactions ( DDIs ) between lacosamide and digoxin , this phase I , multiple-dose , randomised , double-blind , placebo-controlled , crossover trial assessed the pharmacokinetics , pharmacodynamics , safety and tolerability of digoxin administered in combination with lacosamide or placebo .


Twenty healthy White male volunteers were randomised .


After receiving digoxin 0.25 mg three times daily on day 1 ( loading dose ) , participants received digoxin 0.25 mg once daily on days 2-22 .


Participants received either lacosamide ( 200 mg twice daily ) or placebo on days 8-11 and vice versa on days 18-21 , after a 6-day washout .


The steady-state area under concentration-time curve over the dosing interval ( AUC ( 24 , ss ) ) and maximum steady-state plasma concentration ( C ( max , ss ) ) of digoxin were measured ; ratios of these parameters for co-administration of digoxin + lacosamide versus digoxin alone were used to evaluate potential DDIs .


Interaction was excluded if the 90 % confidence interval ( CI ) for the geometric mean ratio of AUC24 , ss and C max , ss fell within the acceptance range for bioequivalence ( 0.8-1 .25 ) .


The point estimates ( 90 % CI ) of the geometric mean ratios for co-administration of digoxin with lacosamide versus digoxin alone for AUC ( 24 , ss ) [ 1.024 ( 0.979-1 .071 ) ] and C ( max , ss ) [ 1.049 ( 0.959-1 .147 ) ] were within the acceptance range for bioequivalence .


Digoxin and lacosamide co-administration was generally well-tolerated .


A small numerical increase in the mean PR interval following co-administered digoxin + lacosamide was observed versus digoxin alone and versus pre-treatment baseline values ( 178.5 vs. 170.4 or 166.8 ms , respectively ) .


The RR interval increased in parallel .


The change was not considered clinically relevant .


Co-administration of steady-state digoxin ( 0.25 mg/day ) with multiple-dose lacosamide ( 400 mg/day ) versus digoxin alone revealed no differences in digoxin disposition .


Providing care for terminally ill family members places an enormous burden on informal caregivers .


Meaning in life ( MiL ) may be a protective factor , but is jeopardised in caregiving and bereavement .


This study evaluates the following questions : To what extent do bereaved informal caregivers of palliative care ( PC ) patients experience meaning in their lives ?


What differences emerge in carers compared to the general German population ?


How does MiL relate to well-being in former caregivers ?


Eighty-four bereaved PC caregivers completed the Schedule for Meaning in Life Evaluation , the Brief Symptom Inventory , the WHOQOL-BREF , a single-item numerical rating scale of quality of life , and the Satisfaction with Life Scale .


The experience of MiL of bereaved caregivers was compared to a representative population sample ( n = 977 ) .


The overall MiL fulfillment of bereaved caregivers ( 69 % female , age 55.5 12.9 years ) was significantly lower than in the general population ( 68.5 19.2 vs. 83.3 14 , p < .001 ) , as was the overall importance ascribed to their meaning framework ( 76.6 13.6 vs. 85.6 12.3 , p < .001 ) .


PC caregivers are far more likely to list friends , leisure , nature/animals , and altruism .


Higher MiL was correlated with better life satisfaction and quality of life .


Coping with the loss of a loved one is associated with changes in MiL framework and considerably impairs a carer 's experience of MiL fulfillment .


Individual MiL is associated with well-being in PC caregivers during early bereavement .


Specific interventions for carers targeted at meaning reconstruction during palliative care and bereavement are needed to help individuals regain a sense of meaning and purpose .


To compare periodontal ligament anesthesia using a computer-controlled local anesthetic delivery system ( C-CLADS ) and submucosal infiltration anesthesia using a manually operated syringe in terms of the injection pain , anesthetic effect , anesthetic dose , and complications in healthy volunteers .


Fifty healthy volunteers , aged 18 to 56 years , were recruited from September 2012 to May 2013 in the Department of Stomatology of Peking Union Medical College Hospital .


A randomized self-controlled trial was conducted by applying a periodontal ligament anesthesia on one side and conventional manual submucosal infiltration anesthesia to the other ( control ) side .


The differences in the onset time of anesthesia , drug dosage , anesthetic effect , and the degree of injection pain were compared .


The complications associated with the two anesthesia methods were also recorded .


When using C-CLADS to perform a periodontal ligament anesthesia , the drug dosage and the severity of injection pain were significantly less than those of conventional manual infiltration anesthesia [ drug dosage : ( 0.340.09 ) ml vs. ( 0.550.13 ) ml , P < 0.01 ; VRS : 0.420.73 vs. 1.380.92 , P < 0.01 ; VAS : 1.341.21 vs. 3.101.70 , P < 0.01 ] .


The anesthesia success rate was approximately 90.0 % , showing no significant difference relative to conventional submucosal infiltration anesthesia .


Approximately 24 % of the volunteers experienced postoperative pain after periodontal ligament anesthesia .


Compared with conventional submucosal infiltration anesthesia using manual syringes , periodontal ligament anesthesia performed using C-CLADS can reduce the injection pain and drug dosage while achieving a satisfactory anesthetic effect ; however , a considerable proportion of cases may experience postoperative pain .


Basal-cell carcinoma is the most common form of skin cancer and its incidence is increasing worldwide .


We aimed to assess the effectiveness of imiquimod cream versus surgical excision in patients with low-risk basal-cell carcinoma .


We did a multicentre , parallel-group , pragmatic , non-inferiority , randomised controlled trial at 12 centres in the UK , in which patients were recruited between June 19 , 2003 , and Feb 22 , 2007 , with 3 year follow-up from June 26 , 2006 , to May 26 , 2010 .


Participants of any age were eligible if they had histologically confirmed primary nodular or superficial basal-cell carcinoma at low-risk sites .


We excluded patients with morphoeic or recurrent basal-cell carcinoma and those with Gorlin syndrome .


Participants were randomly assigned ( 1:1 ) via computer-generated blocked randomisation , stratified by centre and tumour type , to receive either imiquimod 5 % cream once daily for 6 weeks ( superficial ) or 12 weeks ( nodular ) , or surgical excision with a 4 mm margin .


The randomisation sequence was concealed from study investigators .


Because of the nature of the interventions , masking of participants was not possible and masking of outcome assessors was only partly possible .


The trial statistician was masked to allocation until all analyses had been done .


The primary outcome was the proportion of participants with clinical success , defined as absence of initial treatment failure or signs of recurrence at 3 years from start of treatment .


We used a prespecified non-inferiority margin of a relative risk ( RR ) of 0.87 .


Analysis was by a modified intention-to-treat population and per protocol .


This study is registered as an International Standard Randomised Controlled Trial ( ISRCTN48755084 ) , and with ClinicalTrials.gov , number NCT00066872 .


501 participants were randomly assigned to the imiquimod group ( n = 254 ) or the surgical excision group ( n = 247 ) .


At year 3 , 401 ( 80 % ) patients were included in the modified intention-to-treat group .


At 3 years , 178 ( 84 % ) of 213 participants in the imiquimod group were treated successfully compared with 185 ( 98 % ) of 188 participants in the surgery group ( RR 0.84 , 98 % CI 0.78-0 .91 ; p < 0.0001 ) .


No clear difference was noted between groups in patient-assessed cosmetic outcomes .


The most common adverse events were itching ( 211 patients in the imiquimod group vs 129 in the surgery group ) and weeping ( 160 vs 81 ) .


We recorded serious adverse events in 99 ( 40 % ) of 249 participants in the imiquimod group and 97 ( 42 % ) of 229 in the surgery group had serious adverse events , but none were regarded as related to treatment .


12 ( 5 % ) participants in the imiquimod group withdrew because of adverse events compared with four ( 2 % ) in the surgery group .


Imiquimod was inferior to surgery according to our predefined non-inferiority criterion .


Although excisional surgery remains the best treatment for low-risk basal-cell carcinoma , imiquimod cream might still be a useful treatment option for small low-risk superficial or nodular basal-cell carcinoma dependent on factors such as patient preference , size and site of the lesion , and whether the patient has more than one lesion .


Cancer Research UK .


Sofosbuvir ( GS-7977 ) and GS-0938 are nucleotide analogue HCV polymerase inhibitors , with sofosbuvir being a pyrimidine and GS-0938 being a purine .


Mathematical modelling has provided important insights for characterizing HCV RNA decline and for estimating the in vivo effectiveness of single direct-acting antiviral agents ( DAAs ) ; however it has not been used to characterize viral kinetics with combination DAA therapy .


We evaluated the antiviral activity of sofosbuvir and GS-0938 given alone and in combination for 14 days in 32 HCV genotype 1 treatment-naive patients ( P2938-0212 ; NUCLEAR study ) .


Viral load declined rapidly in a biphasic manner in all subjects and could be well fitted by assuming that both drugs had a similar and additive level of effectiveness in reducing viral production equal to 99.96 % , on average .


The model predicted that this level of effectiveness was not reached until 0.6 and 2 days for GS-0938 and sofosbuvir , respectively , and likely represents the time needed to accumulate intracellular triphosphates .


Subsequently , both drugs led to a rapid second phase of viral decline with a mean rate of 0.35 d ( -1 ) .


No effect of IL28B-polymorphism was found on viral kinetic parameters .


Both sofosbuvir and GS-0938 are highly effective at blocking viral production from HCV-infected cells .


Both drugs led to a rapid and consistent second phase viral decline and exhibited no breakthroughs or other signs of resistance .


From a kinetics perspective , because both drugs were of the same class there was little benefit in combining them , suggesting that future DAA combinations should consider utilizing drugs with different modes of action .


To evaluate the effects of early norepinephrine ( NE ) infusion in children submitted to mechanical ventilation ( MV ) requiring continuous sedative and analgesic infusion .


Double-blinded , randomized , placebo-controlled trial enrolling children ( 1 month to 12 years of age ) admitted to a Brazilian PICU and expected to require MV and continuous sedative and analgesic drug infusions for at least five days .


Children were randomized to receive either norepinephrine ( NE ) ( 0.15 mcg/kg/min ) or normal saline infusion , started in the first 24 hours of MV , and maintained for 72 hours .


We compared hemodynamic variables , fluid intake , renal function and urine output between groups .


Forty children were equally allocated to the NE or placebo groups , with no differences in baseline characteristics , laboratorial findings , PRISM II score , length of MV , or mortality between groups .


The average norepinephrine infusion was 0.143 mcg/kg/min .


The NE group showed higher urine output ( p = 0.016 ) and continuous increment in the mean arterial pressure compared to the baseline ( p = 0.043 ) .


There were no differences in the remaining hemodynamic variables , fluid requirements , or furosemide administration .


Early norepinephrine infusion in children submitted to MV improves mean arterial pressure and increases urine output .


These effects were attributed to reversion of vasoplegia induced by the sedative and analgesic drugs .


Left atrial volume ( LAV ) is an important marker of heart failure ( HF ) severity .


We hypothesized that LAV independently correlates with clinical outcomes in patients who receive cardiac resynchronization therapy with a defibrillator ( CRT-D ) and can be used for improved risk assessment in this population .


The benefit of CRT-D versus defibrillator-only therapy in reducing the risk of HF or death was assessed by LAV ( dichotomized at the upper quartile > 52 mL/m2 ) among 1785 patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial with Cardiac Resynchronization Therapy ( MADIT-CRT ) study .


Landmark analysis was used to evaluate the relationship between LAV response to CRT-D and subsequent clinical outcomes .


Multivariable analysis showed that patients with a higher baseline LAV experienced 69 % ( P < 0.001 ) and 59 % ( P = 0.02 ) increased hazard for HF or death and for all-cause mortality , respectively , independently of baseline left ventricular volume .


CRT-D was associated with a significant reduction in LAV compared with defibrillator-only therapy ( -28 % versus -10 % , respectively ; P < 0.001 ) .


Landmark analysis showed that after CRT-D implantation each 1 % reduction in LAV was independently associated with a corresponding 4 % reduction in the hazard of subsequent HF or death ( P < 0.001 ) .


The assessment of LAV change after CRT implantation improved prediction of clinical response to the device compared with assessment of the corresponding changes in left ventricular volume .


LAV is an independent correlate of clinical outcomes in mildly symptomatic HF patients treated with CRT-D .


CRT exerts pronounced reverse remodeling effects on the left atrium that independently correlate with improved clinical outcomes after device implantation .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00180271 .


Erlotinib is a drug used to treat non-small cell lung cancer , pancreatic cancer and several other types of cancer .


It is a reversible tyrosine kinase inhibitor that acts on the epidermal growth factor receptor and inhibits cell proliferation , growth , migration , invasion and survival .


This study was performed for the subsequent marketing of a test erlotinib formulation in Korea .


We evaluated the comparative bioavailability and tolerability of the test and reference formulations in healthy adult volunteers .


A total of 46 healthy male subjects were enrolled in a single-dose , randomized , open-label , two-period , two-sequence , crossover , bioequivalence study .


During each treatment period , subjects received 150 mg of erlotinib in either the test or reference formulation .


There was a 2-week washout period between each period .


Blood samples were obtained 15 times during each period , before dosing and 0.5 , 1 , 1.5 , 2 , 2.5 , 3 , 4 , 6 , 8 , 12 , 24 , 48 , 72 and 96 h after oral administration .


Plasma concentrations of erlotinib were determined using liquid chromatography-tandem mass spectrometry .


Pharmacokinetic parameters , including maximum plasma concentration ( C ( max ) ) , area under the plasma concentration-time curve to the last sampling time ( AUC ( t ) ) , AUC from time zero to infinity ( AUC ( ) ) , and time to reach C ( max ) ( t ( max ) ) , were measured , and all treatment-emergent adverse events and their relationships with the study medications were recorded throughout the study .


An additional analysis was performed to characterize the association between the cytochrome P450 ( CYP ) 1A1 , CYP1A2 and CYP3A4 genotypes and the erlotinib pharmacokinetic parameters .


A total of 41 subjects completed the study .


There were no significant differences in the prevalence of adverse events between the two formulations , and there were no serious or unexpected adverse events during the study .


Both formulations had very similar C ( max ) , AUC , terminal half-life ( t ) and t ( max ) values .


The 90 % confidence intervals of the geometric least-squares mean ratios of the test to reference formulation were 1.09 ( 0.98-1 .22 ) for C ( max ) and 1.10 ( 1.01-1 .21 ) for AUCt .


Statistical significance was observed between the CYP1A2 * 1M genotype and the erlotinib pharmacokinetic parameter , particularly C ( max ) ( p = 0.015 ) .


This study suggests that the test and reference formulations of 150 mg erlotinib have similar pharmacokinetic characteristics .


Both had no major safety issues and were well-tolerated .


The test formulation met the regulatory criteria for assuming bioequivalence to the reference formulation for both AUCt and C max .


The additional genetic analysis demonstrated that the major metabolic enzymes of erlotinib did not significantly affect erlotinib metabolism , with the exception of CYP1A2 * 1M .


Chronic infection with Pseudomonas aeruginosa is associated with an increased exacerbation frequency , a more rapid decline in lung function , and increased mortality in patients with bronchiectasis .


To perform a randomized placebo-controlled study assessing the efficacy and safety of inhaled colistin in patients with bronchiectasis and chronic P. aeruginosa infection .


Patients with bronchiectasis and chronic P. aeruginosa infection were enrolled within 21 days of completing a course of antipseudomonal antibiotics for an exacerbation .


Participants were randomized to receive colistin ( 1 million IU ; n = 73 ) or placebo ( 0.45 % saline ; n = 71 ) via the I-neb twice a day , for up to 6 months .


The primary endpoint was time to exacerbation .


Secondary endpoints included time to exacerbation based on adherence recorded by the I-neb , P. aeruginosa bacterial density , quality of life , and safety parameters .


All analyses were on the intention-to-treat population .


Median time ( 25 % quartile ) to exacerbation was 165 ( 42 ) versus 111 ( 52 ) days in the colistin and placebo groups , respectively ( P = 0.11 ) .


In adherent patients ( adherence quartiles 2-4 ) , the median time to exacerbation was 168 ( 65 ) versus 103 ( 37 ) days in the colistin and placebo groups , respectively ( P = 0.038 ) .


P. aeruginosa density was reduced after 4 ( P = 0.001 ) and 12 weeks ( P = 0.008 ) and the St. George 's Respiratory Questionnaire total score was improved after 26 weeks ( P = 0.006 ) in the colistin versus placebo patients , respectively .


There were no safety concerns .


Although the primary endpoint was not reached , this study shows that inhaled colistin is a safe and effective treatment in adherent patients with bronchiectasis and chronic P. aeruginosa infection .


Clinical trial registered with http://www.isrctn.org/ ( ISRCTN49790596 ) .


Rubbing the skin may influence the persistence of pustulosis over time .


The aim of this study was to assess the impact of a new fabric made with fluorine-synthetic fiber in improving plantar pustulosis .


A total of 17 patients were randomized to receive on one side a sock made of fluorine-synthetic fiber and on the other a sock made of cotton fabric for 4 weeks .


The main outcome was the percentage reduction of lesional area at week 4 .


The median lesion reduction at week 4 was 42.6 % in the fluorine-synthetic fiber arm and 2.7 % in the cotton arm ( p = 0.148 ) .


Among secondary outcomes , the overall reduction over time in the treated areas was significantly in favor of the fluorine-synthetic fiber arm ( p = 0.045 ) as well as the perception of the disease by the patient ( p = 0.025 ) .


Despite the fact that the primary outcome was not reached , there was a tangible reduction in the extension of the treated areas and in the perception of the disease by the patient .


To assess the effectiveness of an educational intervention based on social cognitive theory on increasing consumption of fruit and vegetable among Grade 4 students .


The randomised study was conducted in Isfahan , Iran , during 2011 and comprised 138 students , who were randomly divided into intervention and control groups .


Data was collected at the beginning and three months after the intervention .


A self-administered questionnaire based on constructs of social cognitive theory and food consumption was used .


Theory-based nutrition education was imparted on the intervention group .


Data was analysed using SPSS 15 and appropriate statistical tests .


The intervention group had 68 ( 49.27 % ) subjects , while there were 70 ( 50.72 % ) controls .


After the intervention , mean scores of behavioural capability ( p < 0.001 ) , self-efficacy in difficult situations ( p = 0.04 ) , self-efficacy in selecting fruits and vegetables ( p = 0.01 ) , social support ( p = 0.03 ) , and observational learning ( p = 0.002 ) had significantly improved in the intervention group .


Nutritional behaviour also showed significant improvement on mean daily intake of fruits and vegetables in the intervention group ( p < 0.001 ) .


Intervention based on social cognitive theory led to increase in the consumption of fruits and vegetables among students , which confirmed the efficiency of social cognitive theory for such interventions .


Low-frequency , bilateral stimulation of the subthalamic nucleus can improve axial symptoms of advanced Parkinson 's disease ( PD ) , but it is not particularly effective for segmental symptoms .


The optimal contacts for low-frequency ( 60 Hz ) and high-frequency ( 130 Hz ) single monopolar stimulation were determined .


Then , in a randomized , double-blind , prospective crossover manner , 60-Hz and 130-Hz stimulations via the respective optimal contacts were compared for immediate efficacy in improving the motor function of patients with PD .


The optimal contacts for 60-Hz stimulation were situated more ventrally than those for 130-Hz stimulation ( P = 0.038 ) .


Under the respective optimal , single monopolar stimulation , 60 Hz provided superior efficacy over 130 Hz in improving the total Unified Parkinson 's Disease Rating Scale motor score ( P < 0.001 ) and the akinesia ( P = 0.011 ) and axial motor signs ( P = 0.012 ) subscores without compromising the therapeutic effect on tremor and rigidity .


Low-frequency stimulation via the optimal contacts is effective in improving overall motor function of patients with PD .


Cesarean delivery is a common surgical procedure with anticipated substantial postoperative pain .


The addition of a transversus abdominis plane block ( TAPB ) to a multimodal analgesic regimen that includes intrathecal morphine may provide improved early pain outcomes and decrease the risk of chronic post-surgical pain .


The purpose of this research was to assess the ability of an ultrasound-guided TAPB with low-dose ropivacaine to decrease early postoperative pain , opioid consumption , and risk of developing persistent pain when compared with a placebo block .


Eighty-three women were randomly assigned to either a treatment ( 0.25 % ropivacaine ) or control group ( 0.9 % saline ) in this double-blind trial , and 74 women were included in the final analysis .


Ultrasound-guided TAPBs were performed with an injection of 20mL of study solution per side .


The primary outcome measures of this study were : pain at rest and pain after movement measured with a numeric rating scale , results of the Quality of Recovery-40 ( QoR-40 ) questionnaire , and opioid consumption at 24 hr .


These were used with an a priori sample size calculation to detect a 30 % reduction in pain scores , a 10 % improvement in QoR-40 score , and a 50 % reduction in opioid consumption .


Health quality and physical functioning were assessed using the Short Form 36 ( SF-36 ) Health Survey at 30days and six months .


Assessment at 24 hr after Cesarean delivery revealed no clinically important differences between groups in postoperative pain , QoR-40 , or opioid consumption .


There were no clinically important differences between groups regarding measures of nausea , pruritus , vomiting , urine retention ( 2 , 24 , and 48 hr postoperatively ) , 24-hr QoR-40 sub-dimensions , or the SF-36 Health Survey ( 30days and six months postoperatively ) .


Ultrasound-guided TAPB did not improve postoperative pain , quality of recovery , or opioid consumption 24 hr following surgery .


Similar health and functioning ( SF-36 ) at 30days and six months were reported by both groups .


This trial was registered at ClinicalTrials.gov number : NCT01261637 .


Although the prevalence of congenital malformations is high in China , little information is available on the Hainan Province .


Data used in this study were collected from 2000 to 2010 by monitoring newborns ( including both live births and stillbirths ) in the Hainan Province .


Comparison analyses were conducted by performing ( 2 ) tests .


The data showed an increasing temporal trend of the birth defect prevalence in the Hainan Province ; however , the rate of birth defects changed over time .


The Hainan Province is confronted with the challenge to reduce the prevalence of birth defects .


Interventions should focus on the rural areas where a higher prevalence of birth defects is observed .


The incidence of Clostridium difficile infection ( CDI ) has risen dramatically during the last decade .


Although patients respond well to medical therapy such as vancomycin , 20 % -30 % of patients treated suffer a recurrence of CDI .


We developed a simple/practical scoring rule ( logistic regression model ) for recurrent CDI using data from 2 large phase 3 clinical trials .


Seventy-seven baseline CDI factors were classified : demographics , comorbidity , medications , vital signs , laboratory tests , severity , and symptoms .


Predictors with the highest discrimination in each class ( using receiver operating characteristics curve ) were selected .


For the final model , stepwise selection was performed .


Discrimination , calibration , and internal validation were used to assess the model .


The final model with a simple scoring rule was developed .


It includes 4 independent risk factors that are readily available when the patient makes initial contact : age ( < 75 vs 75 years ) , number of unformed bowel movements during previous 24 hours ( < 10 vs 10 ) , serum creatinine leves ( < 1.2 mg/dL vs 1.2 mg/dL ) and prior episode of CDI ( yes vs no ) .


In addition , the model includes choice of treatment ( vancomycin or fidaxomicin ) .


The prediction model for recurrence may be useful for treatment decision .


NCT00314951 and NCT00468728 .


The Occluded Artery Trial ( OAT ) randomized stable patients ( n = 2201 ) > 24 h ( calendar days 3-28 ) after myocardial infarction ( MI ) with totally occluded infarct-related arteries ( IRA ) , to percutaneous coronary intervention ( PCI ) with optimal medical therapy , or optimal medical therapy alone ( MED ) .


PCI had no impact on the composite of death , reinfarction , or class IV heart failure over extended follow-up of up to 9 years .


We evaluated the impact of early and late reinfarction and definition of MI on subsequent mortality .


Reinfarction was adjudicated according to an adaptation of the 2007 universal definition of MI and the OAT definition ( 2 of the following -- symptoms , EKG and biomarkers ) .


Cox regression models were used to analyze the effect of post-randomization reinfarction and baseline variables on time to death .


After adjustment for baseline characteristics the 169 ( PCI : n = 95 ; MED : n = 74 ) patients who developed reinfarction by the universal definition had a 4.15-fold ( 95 % CI 3.03-5 .69 , p < 0.001 ) increased risk of death compared to patients without reinfarction .


This risk was similar for both treatment groups ( interaction p = 0.26 ) and when MI was defined by the stricter OAT criteria .


Reinfarctions occurring within 6 months of randomization had similar impact on mortality as reinfarctions occurring later , and the impact of reinfarction due to the same IRA and a different epicardial vessel was similar .


For stable post-MI patients with totally occluded infarct arteries , reinfarction significantly independently increased the risk of death regardless of the initial management strategy ( PCI vs. MED ) , reinfarction definition , location and early or late occurrence .


Attention-deficit/hyperactivity disorder ( ADHD ) is the most common neurobehavioral disorder of childhood and has often a chronic course persisting into adulthood .


However , up to 30 % of children treated with stimulants either fail to show an improvement or suffer adverse side effects , including decreased appetite , insomnia and irritability and there is no evidence of long term efficacy of stimulants for ADHD .


A series of studies has shown that neurofeedback is an effective additional or alternative treatment for children with ADHD , leading to e.g. significant and stable improvement in behavior , attention and IQ .


Significant treatment effects of neurofeedback have also been verified in meta-analyses .


Most of the trials , however , have been criticized for methodological difficulties , particularly lacking appropriate control conditions and number of patients included .


This randomized study examines the efficacy of slow cortical potentials ( SCP ) - neurofeedback , controlling unspecific effects of the setting by comparing two active treatment modalities .


A total of 144 patients with ADHD , older than six and younger than ten years , in some cases with additional pharmacological treatment , are included in this trial .


In five trial centres patients are treated either with SCP-feedback or electromyographic ( EMG ) - feedback in 25 sessions within 3months .


A comprehensive test battery is conducted before and after treatment and at follow-up 6month later , to assess core symptoms of ADHD , general psychopathology , attentional performance , comorbid symptoms , intelligence , quality of life and cortical arousal .


The efficacy of SCP-feedback training for children with ADHD is evaluated in this randomized controlled study .


In addition to behavior ratings and psychometric tests neurophysiological parameters serve as dependent variables .


Further , the choice of EMG-biofeedback as an active control condition is debated .


Current Controlled Trials ISRCTN76187185 .


Registered 5 February 2009 .


Medications or lifestyle changes to prevent or improve hypertension often press considerable efforts on patients suffering from mild hypertension .


Capsules including Umezu polyphenols ( UP ) , polyphenols in Japanese plums , may help them to control their blood pressure ( BP ) .


The aim of this study is to evaluate the effectiveness of UP on BP and its safety .


A total of 15 healthy workers without antihypertensive medication who had some concerns about their BP , preferably normal-high BP or hypertension level 1 , were randomized in a double-blind manner into UP ingesting and placebo groups .


Each subject was instructed to take four capsules daily for 12 weeks ( daily UP dose , 800 mg for the UP ingesting group ; and 0 mg for the placebo group ) .


These subjects were followed for 12 weeks , and their BP both at home and at the examination site , as well as self-perceived quality-of-life outcomes and possible side effects , was monitored during that period .


Group time interactions on BP changes were examined .


All of the 15 subjects completed the 12-week intervention trial .


The BP changes did not significantly differ between the UP ingesting and placebo groups , neither at the examination site nor at home .


But during the study period , no adverse effects were observed .


No remarkable effect of UP on BP was observed .


However , a higher dose of UP was confirmed safe and high in adherence in this 12-week randomized controlled trial .


Its effect on BP and other outcomes shall be confirmed in a larger sample .


The purpose of our study was two-fold : 1 ) adapt and test a social support measure specific to the experiences of African American women with type 2 diabetes mellitus ( T2DM ) ; 2 ) examine its relationship to psychosocial measures .


200 rural African American women with uncontrolled T2DM participating in a randomized controlled trial completed surveys at baseline on their social support , empowerment , self-care , self-efficacy , depression and diabetes distress .


Exploratory factor analysis and correlation analysis were conducted to test the psychometric properties of the Dunst Family Support Scale adapted for AA women with T2DM ( FSS-AA T2DM ) and its relationship with other psychosocial measures .


The 16 items of the FSS-AA T2DM loaded onto three distinct factors : parent and spouse/partner support , community and medical support , and extended family and friends support .


Reliability for the entire scale was good ( Cronbach 's = .90 ) and was acceptable to high across these three factors ( Cronbach 's of .86 , .83 , and .83 respectively ) .


All three factors were significantly correlated with self-reported empowerment , self-care , self-efficacy , depression and diabetes distress , although the pattern was different for each factor .


FSS-AA-T2DM showed good concurrent validity when compared with similar items on the Diabetes Distress Scale .


The FSS-AA T2DM , a 16-item scale measuring social support among rural African American women with T2DM , is internally consistent and reliable .


Findings support the utility of this screening tool in this population , although additional testing is needed with other groups in additional settings .


To study the influence of laser radiation on the parameters of microcirculation in patients with gastroesophageal reflux disease ( GERD ) .


The examined 112 patients with GERD aged 19 to 79 years .


78 patients were given a ten-day course of intravenous laser therapy , which was conducted with the help of the apparatus of laser therapy `` matrix-vlok '' ( produced by `` the matrix '' , Russia ) with wavelength 0,405 microns , the radiation power at the output of the main fiber 1-1 ,5 mW , continuous mode radiation .


The studied parameters were determined before and after treatment .


The obtained data testify to the improvement of microcirculation in patients with GERD under the influence of laser therapy .


Signs and symptoms of Cushing 's disease are associated with high burden of illness .


In this analysis , we evaluated the effect of pasireotide treatment on signs and symptoms in patients with Cushing 's disease .


Phase III study with double-blind randomization of two pasireotide doses .


Patients ( n = 162 ) with persistent/recurrent or de novo Cushing 's disease and urinary free cortisol ( UFC ) levels 15 upper limit of normal ( ULN ) were randomized to receive subcutaneous pasireotide ( 600/900 g bid ) .


At month 3 , patients with UFC 2 ULN and not exceeding the baseline value continued their randomized dose ; all others received 300 g bid uptitration .


At month 6 , patients could enter an open-label phase until month 12 with a maximal dose of 1200 g bid .


Changes in signs and symptoms of hypercortisolism over 12 months ' treatment in patients still enroled in the study and with evaluable measurements were assessed in relation to degree of UFC control .


Reductions in blood pressure were observed even without full UFC control and were greatest in patients who did not receive antihypertensive medications during the study .


Significant reductions in total cholesterol and low-density lipoprotein ( LDL ) - cholesterol were observed in patients who achieved UFC control .


Reductions in BMI , weight and waist circumference occurred during the study even without full UFC control .


Adverse effects were typical of somatostatin analogues except for hyperglycaemia-related events , which were experienced by 728 % of patients .


In the largest Phase III study of medical therapy in Cushing 's disease , significant improvements in signs and symptoms were seen during 12 months of pasireotide treatment , as UFC levels decreased .


Tenofovir disoproxil fumarate ( TDF ) has been associated with renal insufficiency .


Co-administration with boosted protease inhibitors , which increases its exposure , may further increase the risk of renal insufficiency .


We compared the incidence of renal events among women taking TDF co-administered with lopinavir/ritonavir ( LPV/r ) versus those co-administering TDF with nevirapine ( NVP ) .


Renal events were defined as a confirmed drop in creatinine clearance associated with a serum creatinine grade 2 or higher , or that leading to treatment modification .


Overall , 741 HIV-infected women were enrolled into the study .


Of these , 24 ( 3.2 % ) had reportable renal events ( 18 in LPV/r arm , six in NVP arm ) .


In multivariate analysis , renal events were significantly associated with the LPV/r arm [ odds ratio ( OR ) 3.12 , 95 % confidence interval ( CI ) 1.21 , 8.05 ; P = 0.019 ] , baseline HIV-1 RNA ( OR 2.65 , 95 % CI 1.23 , 5.69 per 1 log10 copies/ml higher ; P = 0.013 ) and baseline creatinine clearance ( OR 0.83 , 95 % CI 0.70-0 .98 per 10 ml/min higher ; P = 0.030 ) .


In multivariate analysis evaluating renal events requiring treatment modification , only baseline HIV-1 RNA and creatinine clearance were significantly associated ( OR 4.41 , 95 % CI 1.65 , 11.78 per 1 log10 copies/ml higher ; P = 0.003 and OR 0.80 , 95 % CI 0.64 , 0.99 per 10 ml/min higher ; P = 0.040 , respectively ) .


The rates of renal events were relatively low in the two treatment arms .


However , patients taking TDF co-administered with LPV/r had significantly more renal events compared to those co-administered with NVP .


Furthermore , higher baseline HIV RNA and lower creatinine clearance were associated with the development of renal insufficiency requiring treatment modification .


The aim of this study was to evaluate the safety , feasibility and preliminary effects of a high-intensity rehabilitative task-oriented circuit training ( TOCT ) in a sample of multiple sclerosis ( MS ) subjects on walking competency , mobility , fatigue and health-related quality of life ( HRQoL ) .


24 MS subjects ( EDSS 4.890.54 , 17 female and 7 male , 52.5811.21 years , MS duration 15.218.68 years ) have been enrolled and randomly assigned to 2 treatment groups : ( i ) experimental group received 10 TOCT sessions over 2 weeks ( 2 hours/each session ) followed by a 3 months home exercise program , whereas control group did not receive any specific rehabilitation intervention .


A feasibility patient-reported questionnaire was administered after TOCT .


Functional outcome measures were : walking endurance ( Six Minute Walk Test ) , gait speed ( 10 Meter Walk Test ) , mobility ( Timed Up and Go test ) and balance ( Dynamic Gait Index ) .


Furthermore , self-reported questionnaire of motor fatigue ( Fatigue Severity Scale ) , walking ability ( Multiple Sclerosis Walking Scale - 12 ) and health-related quality of life ( Multiple Sclerosis Impact Scale - 29 ) were included .


Subjects ' assessments were delivered at baseline ( T0 ) , after TOCT ( T1 ) and 3 months of home-based exercise program ( T2 ) .


After TOCT subjects reported a positive global rating on the received treatment .


At 3 months , we found a 58.33 % of adherence to the home-exercise program .


After TOCT , walking ability and health-related quality of life were improved ( p < 0.05 ) with minor retention after 3 months .


The control group showed no significant changes in any variables .


This two weeks high-intensity task-oriented circuit class training followed by a three months home-based exercise program seems feasible and safe in MS people with moderate mobility impairments ; moreover it might improve walking abilities .


NCT01464749 .


To evaluate the safety and efficacy of a supraciliary micro-stent ( CyPass Micro-Stent ; Transcend Medical , Menlo Park , California , USA ) for surgical treatment of glaucoma in patients refractory to topical medications .


Multicenter , single-arm interventional study .


Patients with open-angle glaucoma ( Shaffer Grade 3 and 4 ) and uncontrolled medicated intraocular pressure ( IOP ) > 21mm Hg at baseline and candidates for conventional glaucoma surgery were enrolled .


Glaucoma medications were discontinued at surgery and resumed at investigator discretion .


CyPass Micro-Stent implantation was completed in all patients using a standard clear corneal approach .


Adverse events , postoperative IOP changes , and need for IOP-lowering medications during the first 12 postoperative months ( 12M ) were monitored .


Sixty-five eyes were enrolled , and 55 were available at 12M , accounting for loss to follow-up and early termination .


Baseline IOP was 24.5 2.8 mm Hg , and the mean number of medications recorded was 2.2 1.1 .


There were no serious intraoperative events or major adverse events ( eg , retinal or choroidal detachment , persistent uveitis , persistent hyphema , hypotony maculopathy ) .


The most common adverse events included IOP increases > 30mm Hg beyond 1month ( 11 % , 7/65 ) , transient hyphema ( 6 % , 4/65 ) , and cataract progression ( 12 % , 5/41 phakic eyes ) .


Mean IOP was 16.4 5.5 mm Hg at 12months-a 34.7 % reduction ( P < .0001 ) .


Mean medication usage also decreased from baseline to a mean of 1.4 1.3 medications at 12M ( P = .002 ) .


In eyes originally indicated for conventional glaucoma surgery , no secondary surgery was performed in 83 % ( 53/64 ) .


Supraciliary stenting with the CyPass Micro-Stent effectively lowers IOP as a surgical treatment for glaucoma , precluding the need for more invasive glaucoma surgery in > 80 % of patients at 1 year , therebyreducing postoperative glaucoma surgical complications .


We evaluated the outcome of person-centred and integrated Palliative advanced home caRE and heart FailurE caRe ( PREFER ) with regard to patient symptoms , health-related quality of life ( HQRL ) , and hospitalizations compared with usual care .


From January 2011 to October 2012 , 36 ( 26 males , 10 females , mean age 81.9 years ) patients with chronic heart failure ( NYHA class III-IV ) were randomized to PREFER and 36 ( 25 males , 11 females , mean age 76.6 years ) to the control group at a single centre .


Prospective assessments were made at 1 , 3 , and 6 months using the Edmonton Symptom Assessment Scale , Euro Qol , Kansas City Cardiomyopathy Questionnaire , and rehospitalizations .


Between-group analysis revealed that patients receiving PREFER had improved HRQL compared with controls ( 57.619.2 vs. 48.524.4 , age-adjusted P-value = 0.05 ) .


Within-group analysis revealed a 26 % improvement in the PREFER group for HRQL ( P = 0.046 ) compared with 3 % ( P = 0.82 ) in the control group .


Nausea was improved in the PREFER group ( 2.42.7 vs. 1.71.7 , P = 0.02 ) , and total symptom burden , self-efficacy , and quality of life improved by 18 % ( P = 0.035 ) , 17 % ( P = 0.041 ) , and 24 % ( P = 0.047 ) , respectively .


NYHA class improved in 11 of the 28 ( 39 % ) PREFER patients compared with 3 of the 29 ( 10 % ) control patients ( P = 0.015 ) .


Fifteen rehospitalizations ( 103days ) occurred in the PREFER group , compared with 53 ( 305days ) in the control group .


Person-centred care combined with active heart failure and palliative care at home has the potential to improve quality of life and morbidity substantially in patients with severe chronic heart failure .


NCT01304381 .


The practice of traditional Chinese medicine ( TCM ) has a profound history in many Asian countries .


TCM syndrome is a set of characteristic physical signs and symptoms shared by a group of patients .


Syndrome diagnosis and treatment assignment according to the identified TCM syndrome is a long-held practice of Chinese medicine .


Owing to its distinctive way of interpreting illness and administering care , medical practitioners not well educated in TCM theories and practices are generally incapable of giving out prescriptions for Chinese patent drugs .


Currently , the existence of a multitude of Chinese patent drugs marked with largely identical indications is further complicating this situation .


In this multicenter , randomized , controlled , double-blind , double-dummy clinical trial , in which we will use the comparative effectiveness research method , we will compare the efficacy of two commonly used Chinese patent medicines for angina patients diagnosed with qi deficiency and blood stasis syndrome .


A total of 160 patients will be recruited and randomly assigned to receive either ( 1 ) QiShenYiQi dripping pills , Tongxinluo placebo and routine medication or ( 2 ) Tongxinluo capsules , QiShenYiQi placebo and routine medication .


These treatment regimens will be carried out for 4weeks , followed by a 10-day washout period and a 4-week crossover phase in which the treatments in the two patient groups will be exchanged .


Patients will be allowed to choose symptoms that matter most to them and will be grouped accordingly .


Patient-reported outcomes such as the Seattle Angina Questionnaire score and the 15-point Likert scale score will be measured and reported .


The minimally clinical important difference will be calculated and used for efficacy assessment , and correspondence analysis will be performed to identify the best indications for each drug .


The goal of the study is to establish a methodology for the precise identification of the characteristic indications for which a Chinese patent drug is most effective .


The findings of this study will inform the practicality of the proposed evaluation method .


Chinese clinical trials register Chi CTRTTRCC13003732 .


Patients with anxious depression are typically more difficult to treat with monoaminergic antidepressants compared to those with nonanxious depression .


Although novel research has shown that the N-methyl-D-aspartate ( NMDA ) receptor antagonist ketamine has rapidly acting , relatively sustained effects in treating depression , we predicted that , consistent with the existent literature on traditional antidepressants , patients with anxious depression would have a poorer antidepressant response .


Twenty-six inpatients with treatment-resistant major depressive disorder ( MDD ) ( DSM-IV criteria ) received a single infusion of ketamine ( 0.5 mg/kg over 40 minutes ) from January 2006-March 2013 and were followed for 28 days .


A post hoc analysis compared treatment response and relapse using the Montgomery-Asberg Depression Rating Scale ( MADRS ) in patients with anxious versus nonanxious depression .


Anxious depression was defined as MDD plus a Hamilton Depression Rating Scale anxiety/somatization factor score 7 .


Both anxious and nonanxious depressed patients responded positively to ketamine .


A linear mixed model controlling for baseline with the MADRS revealed a significant group main effect ( P = .03 ) and group-by-time interaction ( P = .01 ) .


Post hoc tests indicated that patients with anxious depression had significantly fewer depression symptoms compared to those with nonanxious depression at days 1 through 5 , 9 through 12 , 15 through 17 , and 25 , with no significant group differences in dissociative ( P = .62 ) or psychotic ( P = .41 ) side effects .


Regarding responders , patients with anxious depression relapsed significantly later than those with nonanxious depression ( median SE = 19.0 17.9 vs 1.0 0.0 days to relapse , respectively ; = 9.30 ; P = .002 ) .


Unexpectedly , patients with anxious depression responded better to ketamine than those with nonanxious depression , with longer time to relapse and no side effect differences .


This finding gives promise for the role of novel glutamatergic medications for the treatment of those with anxious depression , a traditionally difficult-to-treat subgroup of depressed patients .


ClinicalTrials.gov identifier : NCT00088699 .


To perform a deterministic cost-utility analysis , from a 1-year societal perspective , of two treatment programs for stress urinary incontinence ( SUI ) without face-to-face contact : one Internet-based and one sent by post .


The treatments were compared with each other and with no treatment .


We performed this economic evaluation alongside a randomized controlled trial .


The study included 250 women aged 18-70 , with SUI1time/week , who were randomized to 3 months of pelvic floor muscle training via either an Internet-based program including e-mail support from an urotherapist ( n = 124 ) or a program sent by post ( n = 126 ) .


Recruitment was web-based , and participants were self-assessed with validated questionnaires and 2-day bladder diaries , supplemented by a telephone interview with a urotherapist .


Treatment costs were continuously registered .


Data on participants ' time for training , incontinence aids , and laundry were collected at baseline , 4 months , and 1 year .


We also measured quality of life with the condition-specific questionnaire ICIQ-LUTSqol , and calculated the quality-adjusted life-years ( QALYs ) gained .


Baseline data remained unchanged for the no treatment option .


Sensitivity analysis was performed .


Compared to the postal program , the extra cost per QALY for the Internet-based program ranged from 200 to 7,253 , indicating greater QALY-gains at similar or slightly higher costs .


Compared to no treatment , the extra cost per QALY for the Internet-based program ranged from 10,022 to 38,921 , indicating greater QALY-gains at higher , but probably acceptable costs .


An Internet-based treatment for SUI is a new , cost-effective treatment alternative .


Vitamin D has immunomodulatory effects in multiple sclerosis ( MS ) .


Vitamin D acts through various mechanisms such as secretion of cytokines .


Interleukin-17 ( IL-17 ) is a critical interleukin in inflammatory response in MS.


This study assessed the effect of oral high dose vitamin D intake on IL-17 levels in MS patients in a double blind randomized clinical trial .


94 patients with a diagnosis of relapsing remitting multiple sclerosis ( RRMS ) were randomized to two groups .


One group received 50,000 IU vitamin D3 every five days for 12weeks .


The other group was given placebo .


Both groups received interferon - ( IFN - ) treatment .


Serum levels of IL-17 were measured at the beginning of the study and after 12weeks .


IL-17 serum levels were 56.7528.72 pg/ml and 30.3175.85 pg/ml in the intervention and placebo group at the beginning of the study , respectively ( MedianIQR , p = 0.338 ) .


After 12weeks , IL-17 levels were 58.9367.93 pg/ml and 46.1394.70 pg/ml in the intervention and placebo group , respectively ( MedianIQR , p = 0.960 ) .


The multiple linear regression analysis indicated that the consumption of vitamin D3 was positively and significantly associated with the logarithm of IL-17 measures ( = 1.719 ; p = 0.002 and R2 = 0.91 ) , adjusted by EDSS scores .


IL-17 levels showed significant change in RRMS patients after receiving high dose vitamin D3 for 12weeks .


To assess the efficacy of securing conjunctival autograft ( CAG ) without glue or sutures , using the patient 's own blood at the surgical site , and to compare it with the current accepted standard of using fibrin glue for graft adherence , in pterygium surgery .


A single-centre , prospective , randomised controlled trial was carried out in 200 eyes of patients with primary pterygia who were advised pterygium excision with CAG .


Enrolled participants were assigned to Group I or II by randomisation .


After excision of pterygium , they underwent CAG with autologous blood in Group I ( 100 eyes ) and CAG with fibrin glue in Group II ( 100 eyes ) .


During follow-up of 1 year , the eyes were assessed for graft adherence and recurrence .


Of the 200 eyes randomised , 6 eyes that did not complete intended follow-up were excluded from final analysis .


Of the 194 eyes ( Group I n = 96 , Group II n = 98 ) , on the first postoperative day , 3 eyes in Group I ( 3.13 % ) had total graft dislodgement requiring regrafting from another site or reattachment with glue .


In Group II also 2 eyes ( 2.04 % ) had graft dislodgement on the first postoperative day requiring regrafting from another site .


During the 1-year follow-up , 6 eyes in Group I ( 6.25 % ) and 8 eyes in Group II ( 8.16 % ) developed recurrence .


Feasibilty of adherence of the graft without glue in pterygium surgery is promising and has results comparable with the fibrin glue technique in terms of long-term outcome and recurrence , suggesting the potential for autologous blood to replace fibrin glue in graft fixation .


Clinical Trial Registry , India : CTRI/2013/06 / 003764 and UTN : U1111-1140-6572 .


The physiological changes that occur during pregnancy , including increased blood volume and cardiac output , can affect hemodynamic control , most profoundly with positional changes that affect venous return to the heart .


By using Osteopathic Manipulative Treatment ( OMT ) , a body-based modality theorized to affect somatic structures related to nervous and circulatory systems , we hypothesized that OMT acutely improves both autonomic and hemodynamic control during head-up tilt and heel raise in women at 30 weeks gestation .


One hundred subjects were recruited at 30 weeks gestation .


The obstetric clinics of UNTHealth in Fort Worth , TX .


Subjects were randomized into one of three treatment groups : OMT , placebo ultrasound , or time control .


Ninety subjects had complete data ( N = 25 , 31 and 34 in each group respectively ) .


Blood pressure and heart rate were recorded during 5 min of head-up tilt followed by 4 min of intermittent heel raising .


No significant differences in blood pressure , heart rate or heart rate variability were observed between groups with tilt before or after treatment ( p > 0.36 ) , and heart rate variability was not different between treatment groups ( p > 0.55 ) .


However , blood pressure increased significantly ( p = 0.02 ) and heart rate decreased ( p < 0.01 ) during heel raise after OMT compared to placebo or time control .


These data suggest that OMT can acutely improve hemodynamic control during engagement of the skeletal muscle pump and this was most likely due to improvement of structural restrictions to venous return .


Chordomas are relatively rare lesions of the bones .


About 30 % occur in the sacrococcygeal region .


Surgical resection is still the standard treatment .


Due to the size , proximity to neurovascular structures and the complex anatomy of the pelvis , a complete resection with adequate safety margin is difficult to perform .


A radical resection with safety margins often leads to the loss of bladder and rectal function as well as motoric/sensoric dysfunction .


The recurrence rate after surgery alone is comparatively high , such that adjuvant radiation therapy is very important for improving local control rates .


Proton therapy is still the international standard in the treatment of chordomas .


High-LET beams such as carbon ions theoretically offer biologic advantages in slow-growing tumors .


Data of a Japanese study of patients with unresectable sacral chordoma showed comparable high control rates after hypofractionated carbon ion therapy only .


This clinical study is a prospective randomized , monocentric phase II trial .


Patients with histologically confirmed sacrococcygeal chordoma will be randomized to either proton or carbon ion radiation therapy stratified regarding the clinical target volume .


Target volume delineation will be carried out based on CT and MRI data .


In each arm the PTV will receive 64 GyE in 16 fractions .


The primary objective of this trial is safety and feasibility of hypofractionated irradiation in patients with sacrococygeal chordoma using protons or carbon ions in raster scan technique for primary or additive treatment after R2 resection .


The evaluation is therefore based on the proportion of treatments without Grade 3-5 toxicity ( CTCAE , version 4.0 ) up to 12 months after treatment and/or discontinuation of the treatment for any reason as primary endpoint .


Local-progression free survival , overall survival and quality of life will be analyzed as secondary end points .


The aim of this study is to confirm the toxicity results of the Japanese data in raster scan technique and to compare it with the toxicity analysis of proton therapy given in the same fractionation .


Using this data , a further randomized phase III trial is planned , comparing hypofractionated proton and carbon ion irradiation .


ClinicalTrials.gov Identifier : NCT01811394 .


Alterations in the advanced glycation end-products ( AGE ) - receptor of AGE ( RAGE ) system are linked to several chronic diseases , which may result from vascular damage .


A high circulating level of the pro-inflammatory RAGE-ligand S100A12 , also known as EN-RAGE , is thought to promote while a high level of soluble RAGE ( sRAGE ) is thought to protect against development of atherosclerotic cardiovascular disease ( CVD ) .


We evaluated circulating S100A12 and sRAGE in relation to clinical characteristics , nutritional status , inflammation and mortality risk in chronic kidney disease ( CKD ) Stage 5 patients starting on dialysis .