The 90 % confidence intervals ( CIs ) for the ratios of the adjusted means for AUC0-24 , maximum concentration ( Cmax ) , and C ( min ) were within the 80 % -125 % bioequivalence range for 30-min intravenous infusions versus oral administration , but exceeded the upper limit for Cmax for the 15-min and rapid infusions .


All intravenous carbamazepine infusions were well tolerated .


Intravenous carbamazepine infusions ( 70 % of oral daily dose ) of 30 - , 15 - , and 2 - to 5-min duration , given every 6 h , maintained patients ' plasma carbamazepine concentrations .


Intravenous carbamazepine 30-min infusions were bioequivalent to oral carbamazepine in patients with normal renal function ; rapid infusions were well-tolerated in this study .


To assess the effectiveness of healthcare team guidance in the implementation of a glycemic control protocol in the non-intensive care unit of a cardiology hospital .


This was a randomized clinical trial comparing 9 months of intensive guidance by a healthcare team on a protocol for diabetes care ( Intervention Group , n = 95 ) with 9 months of standard care ( Control Group , n = 87 ) .


Clinicaltrials.gov : NCT01154413 .


The mean age of the patients was 61.710 years , and the mean glycated hemoglobin level was 7123 mmol/mol ( 8.72.1 % ) .


The mean capillary glycemia during hospitalization was similar between the groups ( 9.82.9 and 9.12.4 mmol/l for the Intervention Group and Control Group , respectively , p = 0.078 ) .


The number of hypoglycemic episodes ( p = 0.77 ) , hyperglycemic episodes ( 47 vs. 50 in the Intervention Group and Control Group , p = 0.35 , respectively ) , and the length of stay in the hospital were similar between the groups ( p = 0.64 ) .


The amount of regular insulin administered was 0 ( 0-10 ) IU in the Intervention Group and 28 ( 7-56 ) IU in the Control Group ( p < 0.001 ) , and the amount of NPH insulin administered was similar between the groups ( p = 0.16 ) .


While guidance on a glycemic control protocol given by a healthcare team resulted in a modification of the therapeutic strategy , no changes in glycemic control , frequency of episodes of hypoglycemia and hyperglycemia , or hospitalization duration were observed .


Dietary carbohydrates may affect metabolic and physiologic parameters .


The present study evaluated whether a combination of two dietary fibers , oligofructose ( OFS ) and pectin ( P ) , altered satiety and glycemic parameters .


The primary objective of this study was to determine whether dietary supplementation for 3weeks with OFS+P would produce a greater reduction in energy intake of an ad libitum test meal compared to control .


This was a single center , randomized , double-blind , placebo-controlled , parallel group study in overweight and obese , otherwise healthy , subjects ( N = 96 ) .


There were two OFS+P treatment groups : high-dose ( 30g/d ) , low-dose ( 15g/d ) , and a control group ( maltodextrin 15g/d ) .


Energy intake , appetite measures based on Satiety Labeled Intensity Magnitude ( SLIM ) scale , fasting and post-prandial glucose , and insulin levels and body weight were measured at baseline and at the end of 3weeks .


Adverse events and gastrointestinal tolerability of the treatments were also assessed .


An analysis of covariance ( ANCOVA ) performed on the primary endpoint change from baseline in energy intake , showed no statistically significant difference in energy intake among the three treatment groups ( p = 0.5387 ) .


The LS mean changes ( SE ) in energy intake from baseline to week 3 were -58.3 ( 42.4 ) kilocalories ( kcal ) for the high dose group , -74.2 ( 43.6 ) kcal for the low dose group , and -9.0 ( 42.9 ) kcal for the control group .


For the pairwise comparisons of OFS+P doses and control , confidence intervals were constructed around the difference in LS mean changes .


All study products were generally well tolerated .


There was a directional benefit in ad libitum energy intake for both OFS+P doses compared to control , with a greater reduction in kilocalories in the low dose comparison , but the reductions were not significant .


Further studies are warranted .


GSK Clinical Study Register # W7781293 .


To examine protocol fidelity among teachers involved in a six-month cluster-randomized physical activity ( PA ) intervention .


In 2011 , preschools in Springfield , MA were randomized to short bouts of structured PA ( SBS-PA , n = 5 ) or unstructured playtime ( UPA , n = 5 ) .


SBS-PA provided structured PA in the classroom during the first 10 min of gross-motor playtime followed by 20 min of unstructured playtime .


UPA consisted of 30 min of unstructured playtime .


All teachers ( SBS-PA and UPA ) received a written study protocol and 1.5 h of training .


SBS-PA also received videos to use to lead structured PA and 1.5 additional hours of training .


Study fidelity and process evaluation were assessed twice weekly via semi-structured questionnaire .


Only 56.6 % of SBS-PA and 75.2 % of UPA free playtimes lasted for 30 min ; 86.3 % of SBS-PA teachers implemented structured PA during the first 10 min of gross-motor playtime but only 67.2 % delivered the intervention as instructed .


Only 68.5 % of SBS-PA teachers implemented the 20-minute unstructured playtime .


SBS-PA teachers reported that time limitations was a major barrier in implementing the designed intervention .


Pre-post changes in PA did not differ between groups .


Limited fidelity to intervention protocol likely impacted study findings .


Future studies should focus on strategies to improve adherence among intervention leaders .


Advanced pancreatic cancer ( APC ) , in addition to its high mortality , accounts for the highest rates of venous thromboembolic events ( VTEs ) .


Enoxaparin , a low-molecular weight heparin , is effective in prevention and treatment of VTEs .


Some small studies have indicated that this benefit might extend to patients with cancer .


Patients with histologically proven APC were randomly assigned to ambulant first-line chemotherapy and prophylactic use of enoxaparin or chemotherapy alone to investigate the probable reduction in symptomatic VTEs and the impact on survival .


A total of 312 patients were recruited as one of the protocol end points was reached .


Within the first 3 months , the numbers of symptomatic VTEs were as follows : 15 of 152 patients in the observation group and two of 160 patients in the enoxaparin group ( hazard ratio [ HR ] , 0.12 ; 95 % CI , 0.03 to 0.52 ; ( 2 ) P = .001 ) .


The numbers of major bleeding events were as follows : five of 152 patients in the observation arm and seven of 160 patients in the enoxaparin arm ( HR , 1.4 ; 95 % CI , 0.35 to 3.72 ; ( 2 ) P = 1.0 ) .


Overall cumulative incidence rates of symptomatic VTEs were 15.1 % ( observation ) and 6.4 % ( enoxaparin ; HR , 0.40 ; 95 % CI , 0.19 to 0.83 ; P = .01 ) .


Progression-free ( HR , 1.06 ; 95 % CI , 0.84 to 1.32 ; P = .64 ) and overall survival ( HR , 1.01 ; 95 % CI , 0.87 to 1.38 ; P = .44 ) did not differ between groups .


This study demonstrates the high efficacy and feasibility of primary pharmacologic prevention of symptomatic VTEs in outpatients with APC .


Treatment efficacy was not affected by simultaneous treatment with enoxaparin in this trial setting .


As spaceflight compromises skeletal muscle oxidative and aerobic work capacity , this study assessed the efficacy of resistance exercise ( RE ) to counteract muscle metabolic perturbations induced by 5 wk unilateral lower limb unloading ( UL ) .


There were 21 men and women ( 30-56 yr ) who were randomly assigned to either UL with ( Group , Grp ; UL+RE ; N = 10 ) or without ( Grp UL ; N = 11 ) concurrent RE .


Iso-inertial RE comprised four sets of seven maximal coupled concentric-eccentric knee extensions executed 2-3 times per week .


Percutaneous biopsies were obtained from m. vastus lateralis before and after either intervention .


Levels of mRNA expression of factors regulating skeletal muscle oxidative capacity i.e. , peroxisome proliferator-activated receptor gamma coactivator-1 ( PGC-1alpha ) and vascular endothelial growth factor ( VEGF ) , and glycolytic capacity , i.e. , phosphofructokinase ( PFK ) , glycogen phosphorylase and synthase , hexokinase , and phosphorylase kinase alpha1 , were subsequently analyzed .


Grp UL showed decreased ( 36 % ) PGC-1alpha expression , increased ( 1.5-fold ) PFK expression , and a trend toward decreased VEGF post-intervention .


Grp UL+RE showed no changes .


These results suggest that 5 wk unloading reduces skeletal muscle oxidative capacity and increases glycolytic enzyme activity .


More importantly , only 12 bouts of high-force , low-volume resistance exercise attenuated these responses .


Thus , the current resistance exercise paradigm emphasizing eccentric overload effectively counteracts unwarranted metabolic alterations induced by 5 wk unloading and may , therefore , aid in maintaining skeletal muscle integrity and endurance , and hence astronaut health and fitness during spaceflight .


Anti-leishmanial drug regimens that include a single dose AmBisome could be suitable for eastern African patients with symptomatic visceral leishmaniasis ( VL ) but the appropriate single dose is unknown .


A multi-centre , open-label , non-inferiority , randomized controlled trial with an adaptive design , was conducted to compare the efficacy and safety of a single dose and multiple doses of AmBisome for the treatment of VL in eastern Africa .


The primary efficacy endpoint was definitive cure ( DC ) at 6 months .


Symptomatic patients with parasitologically-confirmed , non-severe VL , received a single dose of AmBisome 7.5 mg/kg body weight or multiple doses , 7 times 3 mg/kg on days 1-5 , 14 , and 21 .


If interim analyses , evaluated 30 days after the start of treatment following 40 or 80 patients , showed the single dose gave significantly poorer parasite clearance than multiple doses at the 5 % significance level , the single dose was increased by 25 mg/kg .


In a sub-set of patients , parasite clearance was measured by quantitative reverse transcriptase ( qRT ) PCR .


The trial was terminated after the third interim analysis because of low efficacy of both regimens .


Based on the intention-to-treat population , DC was 85 % ( 95 % CI 73-93 % ) , 40 % ( 95 % CI 19-64 % ) , and 58 % ( 95 % CI 41-73 % ) in patients treated with multiple doses ( n = 63 ) , and single doses of 75 ( n = 21 ) or 10 mg/kg ( n = 40 ) , respectively .


qRT-PCR suggested superior parasite clearance with multiple doses as early as day 3 .


Safety data accorded with the drug label .


The tested AmBisome regimens would not be suitable for VL treatment across eastern Africa .


An optimal single dose regimen was not identified .


www.clinicaltrials.govNCT00832208 .


It is not clear whether Modic changes ( MC ) is associated with low back pain ( LBP ) outcome .


To study associations between baseline degenerative manifestations and outcome in sick-listed LBP patients .


Prospective nested cohort study based on a randomized controlled trial .


Out of 325 sick-listed LBP patients , 141 were consecutively examined by magnetic resonance imaging ( MRI ) and included and 140 completed the study .


Degenerative manifestations of the lumbar spine were quantified ; associations were studied in relation to the three primary outcomes : change of back + leg pain , change of function as measured by Roland-Morris questionnaire , and 1-year unsuccessful return to work ( U-RTW ) .


By using a previously validated MRI protocol , a specialist in radiology , who had no access to clinical data , described the images .


Associations were studied by linear and logistic regression with adjustment for previously identified prognostic factors for 1-year pain and function and for U-RTW .


Clinically , 43 % of the patients had radiculopathy .


Degenerative changes were prevalent with altered disc contours in 84 % , high-intensity zones in 70 % , and nerve root touch or impingement in 63 % of the patients .


MC was identified in 60 % of the patients , 18 % with Type 1 changes and 42 % with Type 2 changes , Type 1 including both Type 1 and Type 1 in combination with Type 2 .


Patients with Type 1 changes reported more back pain and did not improve in pain or disability .


They increased to include 30 % of the patients with U-RTW at 1 year .


Patients with Type 2 changes did not differ significantly from patients without MC but differed significantly from patients with Type 1 changes in all three outcomes .


Other degenerative manifestations were not significantly associated with any of the three outcomes .


The only degenerative manifestation negatively associated with outcome was Type 1 MC that affected 18 % of the cohort at baseline and implied an increased risk for no improvement in pain and function and for U-RTW , even after adjustment for other prognostic factors .


Knowledge of the excess hospital costs and prolonged length of stay attributable to perioperative respiratory event ( PRE ) in pediatric anesthesia is useful for hospital planning .


In this study , we compared costs ( excess hospital costs and indirect costs ) and length of hospital stay between children who had PRE and did not have PRE for noncardiac surgery at a tertiary care hospital in southern Thailand .


A prospective matched cohort study was conducted in children aged < 15 years who underwent general anesthesia between November 2012 and December 2013 at Songklanagarind Hospital .


PRE children were matched with no PRE children ( 1:1 ) using a random selection procedure on outpatients/inpatients , type of surgery , surgical charge ( baht ) , ASA physical status , age difference < 9 years , and difference in time of surgery < 6 months .


Primary end points were excess hospital costs and number of days hospitalized after surgery .


Number of days hospitalized after surgery , excess hospital costs and indirect costs regarding transportation , and income loss of parents between groups were compared using Wilcoxon signed rank test .


Any hospital stay after surgery between groups was compared using McNemar test .


A hurdle model was used to predict any hospital stay and number of days hospitalized after surgery .


Multiple mixed-effects linear regression was used to identify predictors of adjusted excess hospital costs and indirect costs .


A total 430 children were included ( 215 matched pairs ) .


More PRE children required hospital stay after surgery ( 81 % vs 72 % , P = 0.004 ) , and PRE children had a longer number of days hospitalized after surgery ( median [ interquartile ranges ] : 1 [ 1-3 .5 ] vs 1 [ 0-2 ] ; P < 0.001 ) and incurred higher excess costs ( P < 0.001 ) but not indirect costs ( P = 0.23 ) .


In multivariate analysis , PRE was a significant predictor for hospital stay after surgery ( odds ratio , 2.56 ; 95 % confidence interval , 1.23-5 .31 ) , longer hospitalization ( count ratio , 2.10 [ 1.31-3 .35 ] ) , higher excess costs ( cost ratio , 1.30 [ 1.12-1 .53 ] ) , and indirect cost ( cost ratio , 1.58 [ 1.20-2 .08 ] ) after adjusting for patient and anesthesia characteristics .


Universal coverage ( 74 % ) was associated with 35 % and 64 % higher excess cost compared with the Comptroller General 's Department ( 17 % ) and self-pay ( 7 % ) , respectively ( P = 0.003 ) .


The effects of PRE in pediatric anesthesia were hospital stay after surgery , 2 times longer hospitalization , 30 % higher excess hospital costs , and 58 % higher indirect cost among outpatients .


Hospital policy to efficiently manage hospital beds and compensatory budget should be developed .


The level of evidence regarding the association between red and processed meat intakes and breast cancer risk is still low , due to insufficient prospective studies .


Moreover , mechanistic data suggest that some antioxidants may modulate this relationship but epidemiological evidence is lacking .


Our objectives were to investigate relationships between red and processed meat intakes and breast cancer risk , and to study whether an antioxidant supplementation modulates these associations , which , to our knowledge , has never been investigated before .


The SU.VI.MAX study was a randomized , double-blind , placebo-controlled trial in which participants received a combination of low-dose antioxidants or a placebo from 1994 to 2002 .


This observational prospective analysis included 4684 women among whom 190 developed a first incident breast cancer between 1994 and 2007 [ mean ( range ) follow-up = 11.3 ( 0-13 ) years ] .


Baseline dietary data were assessed by repeated dietary records in 1994-1995 .


Associations between quartiles of red and processed meat intakes and breast cancer risk were characterized by multivariate Cox proportional hazards models .


Breast cancer risk was directly associated with processed meat intake [ hazard ratio ( HR ) Q4vsQ1 = 1.45 ( 0.92-2 .27 ) , Ptrend = 0.03 ] and this association was stronger when excluding cooked ham [ HRQ4vsQ1 = 1.90 ( 1.18-3 .05 ) , Ptrend = 0.005 ] .


In stratified analyses , processed meat intake was directly associated with breast cancer risk in the placebo group only [ HRQ4vsQ1 = 2.46 ( 1.28-4 .72 ) , Ptrend = 0.001 ] , but not in the supplemented group [ HRQ4vsQ1 = 0.86 ( 0.45-1 .63 ) , Ptrend = 0.7 ] .


Processed meat intake was prospectively associated with increased breast cancer risk .


This study also suggests that antioxidants may modulate this association by counteracting the potential pro-carcinogenic effects of processed meat on breast cancer .


To evaluate long-term safety and efficacy of tofogliflozin in Japanese patients with type 2 diabetes as monotherapy or in combination with other oral antidiabetic agents , we conducted 52-week , open-label , randomized controlled trials .


The single-agent trial included patients with inadequate glycemic control on diet and exercise , whereas the add-on trial included those uncontrolled with any of the oral antidiabetic agents .


In both trials , patients were randomly assigned to receive tofogliflozin 20 or 40 mg once daily orally for 52 weeks .


Safety assessments .


A total of 194 patients ( 65 , 20-mg group ; 129 , 40-mg group ) were enrolled into the single-agent trial , whereas 602 ( 178 and 424 , respectively ) were enrolled into the add-on trial .


Tofogliflozin was well tolerated for 52 weeks in both trials with < 6 % of treatment discontinuation because of adverse events in each treatment group .


It also reduced hemoglobin A1c .


In the single-agent trial , mean reductions at 52 weeks were 0.67 and 0.66 % in the 20 - and 40-mg groups , respectively .


In the add-on trial , mean reductions ranged from 0.71 to 0.93 % across the subgroups by dose and background therapy .


Tofogliflozin was well tolerated and showed sustained efficacy in both trials .


This 8-week , randomized , double-blind , placebo-controlled study , conducted August 2010-May 2012 in the United States , evaluated the safety and efficacy of vortioxetine 10 mg and 15 mg in patients with major depressive disorder ( MDD ) .


The mechanism of action of vortioxetine is thought to be related to direct modulation of serotonin ( 5-HT ) receptor activity and inhibition of the serotonin transporter .


Adults aged 18-75 years with MDD ( DSM-IV-TR ) and Montgomery-Asberg Depression Rating Scale ( MADRS ) total score 26 were randomized ( 1:1:1 ) to receive vortioxetine 10 mg or 15 mg or placebo once daily , with the primary efficacy end point being change from baseline at week 8 in MADRS analyzed by mixed model for repeated measures .


Adverse events were recorded during the study , suicidal ideation and behavior were assessed using the Columbia-Suicide Severity Rating Scale ( C-SSRS ) , and sexual dysfunction was assessed using the Arizona Sexual Experience ( ASEX ) scale .


Of the 1,111 subjects screened , 469 subjects were randomized : 160 to placebo , 157 to vortioxetine 10 mg , and 152 to vortioxetine 15 mg .


Differences from placebo in the primary efficacy end point were not statistically significant for vortioxetine 10 mg or vortioxetine 15 mg .


Nausea , headache , dry mouth , constipation , diarrhea , vomiting , dizziness , and flatulence were reported in 5 % of subjects receiving vortioxetine .


Discontinuation due to adverse events occurred in 7 subjects ( 4.4 % ) in the placebo group , 8 ( 5.2 % ) in the vortioxetine 10 mg group , and 12 ( 7.9 % ) in the vortioxetine 15 mg group .


ASEX total scores were similar across groups .


There were no clinically significant trends within or between treatment groups on the C-SSRS , laboratory values , electrocardiogram , or vital sign parameters .


In this study , vortioxetine did not differ significantly from placebo on MADRS total score after 8 weeks of treatment in MDD subjects .


ClinicalTrials.gov identifier : NCT01179516 .


To examine the value of self-treatment for Posterior canal benign paroxysmal positional vertigo ( PC-BPPV ) .


The treatment effect was compared between patients treated with modified Epley in outpatient clinic combined with self treatment at home and patients treated by modified Epley alone .


A randomized controlled trial were carried out in the Department of Otolaryngology Head and Neck Surgery , the Affiliated Sixth People 's Hospital of Shanghai Jiao Tong University from December 2012 to May 2013.147 out of 150 patients with unilateral idiopathic BPPV-PSC were enrolled in follow-up .


Among which , 73 patients were allocated in modified Epley-alone group and 74 were allocated in slef-treatment group .


The success rate was 53.4 % in modified Epley-alone group vs 83.8 % in self-treatment group ( P < 0.01 ) after 1 week treatment .


In the modified Epley-alone group , the success rate of hand repositioning group and chair-assisted repositioning group was 45.9 % vs 61.1 % ( P > 0.05 ) , the risk rate was 0.752 , 95 % CI ( 0.486 - 1.163 ) .


In the self-treatment group , the success rate of hand repositioning group and chair-assisted repositioning group was 87.5 % vs 81.0 % ( P > 0.05 ) , the risk rate was 1.081 , 95 % CI ( 0.888-1 .316 ) .


Incidence rate of serious complications was 0 % in the modified Epley-alone group and 1.3 % in the self-treatment group ( P > 0.05 ) .


Complementary self-treatment with modified Epley maneuver treated PC-BPPV sooner and more effectively , Compared with modified Epley maneuver alone .


And its incidence rate of serious complications did n't increase .


Chair-assisted repositioning showed better result than hand repositioning alone , and self-treatment at home can reduce the effect of the gap .


We found that complementary self-treatment with modified Epley maneuver had more benefits for patients with PC-BPPV .


The use of isotonic electrolytic solutions for the intraoperative fluid management in children is largely recognized , but the exact composition still needs to be defined .


The primary objective of this randomized controlled open trial was to compare the changes in chloride plasma concentration using two intraoperative isotonic fluid regimens ( Sterofundin vs. normal saline , both added with 1 % of glucose ) in children undergoing major surgery .


Secondary objectives were to compare changes in other electrolytes , renal function , and the occurrence of hypoglycemia .


Children aged between 1 and 36 months , scheduled for major surgery , were randomized to receive Sterofundin or saline during the intraoperative time .


Children with preoperative electrolyte abnormalities , hemodynamic instability , and severe renal or hepatic dysfunction were excluded .


The primary outcome was the of Cl ( - ) ( = change in plasma concentration between post - and pre-infusion ) , and secondary outcomes included of other electrolytes and intraoperative hypoglycemia .


A total of 240 patients were included in the two study sites and randomized to receive Sterofundin plus 1 % glucose or normal saline plus 1 % glucose , in a open fashion ( 229 were finally analyzed ) .


of Cl - and Mg + + was statistically less relevant in patients who received intraoperative Sterofundin , and of the other electrolytes was comparable between the two study groups .


Relative risk of hyperchloremia was significantly higher when large volumes were infused ( over than 46.7 mlkg ( -1 ) ) , regardless of type of crystalloid infused .


Hypoglycemia occurred in two of 229 patients .


Sterofundin is safer than normal saline in protecting young children undergoing major surgery against the risk of increasing plasma chlorides and the subsequent metabolic acidosis .


Treatment with azathioprine within 3 months of remission induction with cyclophosphamide is a common treatment strategy for patients with ANCA-associated vasculitis .


This study comprised patients undergoing long-term follow-up who were randomly allocated to azathioprine after 3-6 months or after 12 months of cyclophosphamide treatment .


Patients from 39 European centers between 1995 and 1997 with a new diagnosis of ANCA-associated vasculitis that involved the kidneys or another vital organ were eligible .


At the time of diagnosis , participants were randomly allocated to convert to azathioprine after 3-6 months ( the azathioprine group ) or after 12 months of cyclophosphamide ( the cyclophosphamide group ) .


Patients who did not achieve a remission within 6 months were excluded .


This study assessed relapses , ESRD , and death during long-term follow-up .


Patients were allocated to the azathioprine group ( n = 71 ) and the cyclophosphamide group ( n = 73 ) .


Of these patients , 63 ( 43.8 % ) developed a relapse , 35 ( 24.3 % ) developed a renal relapse , 13 ( 9.0 % ) developed ESRD , and 21 ( 14.6 % ) died .


Although there were worse outcomes in the azathioprine group , none were statistically significant .


The subdistribution hazard ratio [ sHR ] for relapse was 1.63 ( 95 % confidence interval [ 95 % CI ] , 0.99 to 2.71 ) , the composite of relapse or death hazard ratio [ HR ] was 1.59 ( 95 % CI , 1.00 to 2.54 ) , the ESRD sHR was 1.71 ( 95 % CI , 0.56 to 5.19 ) , and the death HR was 0.75 ( 95 % CI , 0.32 to 1.79 ) .


It remains uncertain whether converting to azathioprine after 3-6 months of induction cyclophosphamide therapy is as effective as converting after 12 months .


Outcomes are still poor for this group of patients and further research is required to determine the optimal timing of maintenance therapy .


To evaluate the efficacy and safety of Chinese medicine ( CM ) intervention in the treatment of nonalcoholic steatohepatitis ( NASH ) from liver enzyme ( ALT ) , imaging ( the liver/spleen CT ratio ) and syndrome scores , and to establish standard methods for diagnosis and therapeutic efficacy evaluation with characteristics of CM .


A multi-center , stratified randomized , parallel controlled , blindness-method evaluated , superiority trial was performed .


Totally 204 patients were randomly allocated into two groups , 102 patients in the experimental group ( treated with CM ) and 102 patients in the control group [ treated with Western medicine ( WM ) ] .


The alanine aminotransferase ( ALT ) , liver/spleen CT ratio , and clinical symptoms were observed in both groups .


Of the randomly allocated 204 cases from 4 hospitals , 3 patients were rejected , and 25 were lost .


Totally 176 cases con - formed to the plan with complete follow-ups .


After 3 months of treatment , syndrome scores and the improvement of partial clinical symptoms ( fatigue and sallow complexion ) were superior in the experimental group to those in the control group ( P < 0.05 ) .


After 3 months of follow-up , the syndrome scores and improvement of partial clinical symptoms ( fatigue and sallow complexion ) were superior in the experimental group to those in the control group ( P < 0.05 ) .


There was no statistical difference in improving liver enzymes or the liver/spleen CT ratio between the two groups ( P > 0.05 ) .


There were 4 adverse reactions/adverse events in the two groups in the process of treatment , mainly covering drug-induced liver injury , diarrhea , and epigastric distension .


Adverse reactions had nothing to do with CM treatment .


Jianpi Shugan Recipe had obvious efficacy in treatment of NASH .


It could remove the liver fat and play a role in anti-inflammation and liver protection .


It also could improve the indices of liver enzymes and the liver/spleen CT ratio effectively , which was superior to Polyene Phosphatidylcholine Capsule ( PPC ) in improving clinical symptoms , especially for such symptoms as fatigue and sallow complexion .


Chronic obstructive pulmonary disease ( COPD ) is a chronic inflammatory disease mediated by an array of inflammatory cells and mediators , but above all , CD8 + T-lymphocytes , macrophages and neutrophils are important players in disease pathogenesis .


Roflumilast , a first-in-class , potent and selective phosphodiesterase 4 ( PDE4 ) inhibitor , reduces the rate of exacerbations in patients with a high risk of future exacerbations and has been shown to reduce inflammatory cells and mediators in induced sputum , a surrogate of airway inflammation .


However , these anti-inflammatory effects are yet to be confirmed in another robust study directly assessing inflammatory markers in bronchial sub-mucosa .


An international , 16-week , randomized , double-blind , placebo-controlled , parallel-group study investigating the effects of roflumilast 500 g once-daily versus placebo on inflammatory parameters in bronchial biopsy tissue specimens , sputum and blood serum .


One hundred and fifty patients with COPD and chronic bronchitis for at least 12 months will be recruited into the study and randomized in a 1:1 ratio to receive either roflumilast or placebo .


The primary endpoint will be the number of CD8 + cells ( cell counts per mm2 ) in bronchial biopsy tissue specimens ( sub-mucosa ) and the key secondary endpoint will be the number of CD68 + cells ( cell counts per mm2 ) , assessed by indirect immunohistochemistry .


It is hypothesized that treatment with roflumilast reduces the characteristic inflammation found in the airways of patients with moderate-to-severe COPD , compared with placebo .


The design of the present study has built on the work of previous bronchial biopsy studies available in the literature .


It is hoped that it will reveal the cellular mechanisms underlying the anti-inflammatory effects of roflumilast and identify potentially important biomarkers and other surrogate endpoints in patients with COPD .


The design and rationale for this trial are described herein .


Obesity during pregnancy is associated with adverse outcomes for the offspring and mother .


Lifestyle interventions in pregnancy such as antenatal exercise , are proposed to improve both short - and long-term health of mother and child .


We hypothesise that regular moderate-intensity exercise during the second half of pregnancy will result in improved maternal and offspring outcomes , including a reduction in birth weight and adiposity in the offspring , which may be protective against obesity in later life .


The IMPROVE ( Improving Maternal and Progeny Risks of Obesity Via Exercise ) study is a two-arm parallel randomised controlled clinical trial being conducted in Auckland , New Zealand .


Overweight and obese women ( BMI 25kg/m2 ) aged 18-40 years , with a singleton pregnancy of < 20weeks of gestation , from the Auckland region , are eligible for the trial .


Exclusion criteria are ongoing smoking or medical contra-indications to antenatal exercise.Participants are randomised with 1:1 allocation ratio to either intervention or control group , using computer-generated randomisation sequences in variable block sizes , stratified on ethnicity and parity , after completion of baseline assessments .


The intervention consists of a 16-week structured home-based moderate-intensity exercise programme utilising stationary cycles and heart rate monitors , commencing at 20 weeks of gestation .


The control group do not receive any exercise intervention .


Both groups undergo regular fetal ultrasonography and receive standard antenatal care .


Due to the nature of the intervention , participants are un-blinded to group assignment during the trial.The primary outcome is offspring birth weight .


Secondary offspring outcomes include fetal and neonatal body composition and anthropometry , neonatal complications and cord blood metabolic markers .


Maternal outcomes include weight gain , pregnancy and delivery complications , aerobic fitness , quality of life , metabolic markers and post-partum body composition .


The results of this trial will provide valuable insights on the effects of antenatal exercise on health outcomes in overweight and obese mothers and their offspring .


Australian New Zealand Clinical Trials Registry ACTRN12612000932864 .


This randomized clinical trial assessed the effect of three different prosthetic abutments ( titanium , gold-hue titanium and zirconia ) on peri-implant soft tissue 2 years after treatment in partially edentulous subjects .


Baseline data concerning ( 1 ) thickness of the buccal peri-implant soft tissue , ( 2 ) soft tissue thickness above the bone crest , ( 3 ) depth/length of transmucosal pathway , and ( 4 ) periodontal biotype at adjacent teeth were collected .


The final sample consisted of 47 subjects ( 21 males , 26 females ) with a total of 97 implants .


A two-level ( patient , implant ) statistical model was applied .


At the 2-year clinical observation , recession of the gingival margin was observed only at 13 % of implants irrespective of the type of abutment .


No significant correlation between periodontal biotype at adjacent teeth and peri-implant biotype was observed .


Furthermore , none of the investigated variables at patient level ( age , gender , implant type , periodontal biotype ) or at implant level ( keratinized tissue thickness , probing depth , soft tissue thickness ) was identified as a significant predictor of recession .


In conclusion , this study pointed out that ( 1 ) abutment type was not able to influence peri-implant variables after 2 years , and ( 2 ) caution should be used in considering periodontal biotype at patient level as a possible indicator of the future peri-implant biotype .


Transient post-ischemic LV dysfunction due to myocardial stunning in patients with coronary artery disease can be missed by conventional gated SPECT ( GSPECT ) acquisitions .


The aim of this IAEA-sponsored multi-center study was to determine whether early post-exercise imaging is more likely to detect stunning than conventional without adversely affecting image quality or perfusion information .


Patients undergoing exercise/rest GSPECT were enrolled in this international multicenter study .


Post-exercise studies were acquired at 15 5 minutes after radiotracer injection ( Stress-1 ) and repeated at 60 15 minutes ( Stress-2 ) .


Rest studies ( R ) were acquired at 60 minutes post injection .


A core laboratory quantitatively assessed perfusion pattern and LV blinded to the acquisition time .


Ischemia was defined as summed stress score ( SDS ) 4 , and stunning was defined as the difference between rest and post-stress LVEF ( - LVEF ) .


In the 229 patients enrolled into the study , both image quality and perfusion information were similar between Stress-1 and Stress-2 .


Post-stress LVEF was associated with both ischemia and time of acquisition , with a significant correlation between SDS and - LVEF , which was stronger at Stress-1 than Stress-2 in the ischemic compared to the non-ischemic population ( r = 0.23 vs 0.08 , P = 0.10 ) .


Early post-exercise imaging is feasible , and can potentially improve the detection of post-ischemic stunning without compromising image quality and perfusion data .


The aim of this study was to evaluate and compare the long-term clinical outcomes of the spot drug-eluting stent ( DES ) implantation strategy , which is used to minimize implanted stent length and the number of stents , versus full lesion coverage for treatment of coronary artery stenoses .


We evaluated 1-year clinical outcomes of 1619 patients with stent implantation for a single coronary lesion .


They were divided into two groups : those treated by full lesion coverage ( n = 1200 ) and those treated with the spot stenting strategy ( n = 419 ) .


The combined occurrence of 1-year target vessel failure ( TVF ) , including cardiac death , target-vessel related myocardial infarction , or ischemia-driven target-vessel revascularization was evaluated .


The spot DES implantation group had a shorter stent length ( 23.149.70 mm vs. 25.4413.24 mm , respectively ; p < 0.001 ) and a fewer number of stents ( 1.090.30 vs. 1.160.41 , respectively ; p < 0.001 ) , even though the average lesion length was similar to the full lesion coverage group ( 21.3610.30 mm vs. 20.5810.97 mm , respectively ; p = 0.206 ) .


Spot DES implantation was superior to full DES coverage with respect to 1-year TVF ( 1.4 % vs. 3.3 % , p = 0.044 ) .


Cox proportional hazard model analysis showed that the risk for 1-year TVF was almost 60 % lower among patients who received spot DESs compared to those who received full DES coverage after adjustment for other risk factors ( HR = 0.40 , 95 % confidence interval = 0.17-0 .98 ; p = 0.046 ) .


Minimizing stent length and the number of stents with overlapping by spot DES implantation may result in reduced rates of 1-year TVF , compared with full DES coverage .


To compare pro re nata ( PRN ) and monthly injections of 0.5 mg ranibizumab in retinal vein occlusion ( RVO ) patients stabilized by monthly injections .


Randomized , open-label , vision-examiner masked , 15-month study .


Subjects with macular edema secondary to branch or central RVO .


Subjects received monthly injections of 0.5 mg ranibizumab for 7 months and those meeting stability criteria between months 7 and 14 were randomized ( 1:1 ) to PRN injections versus continued monthly injections .


Non-randomized ( NR ) subjects ( never met stability criteria ) received monthly injections .


The primary endpoint was the slope of change in best-corrected visual acuity ( BCVA ) between months 7 and 15 .


There was no significant difference in the slope of change in BCVA between months 7 and 15 in patients treated PRN versus those treated with monthly injections ( P = 0.509 ) .


Mean ( standard deviation ) change from baseline BCVA in Early Treatment Diabetic Retinopathy Study letter score at month 15 was 21.0 14.1 in the PRN group ( n = 82 ) versus 18.7 14.1 in the monthly group ( n = 80 ) and 14.5 14.7 in NR subjects ( n = 13 ) .


The percentage of subjects who achieved BCVA 20/40 at month 15 was 76.8 % in the PRN group , 71.3 % in the monthly group , and 46.2 % in NR subjects .


The mean ( standard deviation ) change from baseline central subfield thickness was -247.8 207.5 m in the PRN group , -289.9 177.2 m in the monthly group , and -93.2 225.2 m in NR subjects .


There were no significant differences in mean BCVA gains or central subfield thickness reductions at month 15 between the PRN and monthly injection groups ( all > 0.05 ) .


After edema resolution from 7 or more monthly ranibizumab injections in RVO subjects , visual outcomes at month 15 were excellent and not significantly different in subjects treated PRN versus those who continued monthly injections .


To determine whether a 3-month contraceptive vaginal ring ( CVR ) delivering ulipristal acetate ( UPA ) can inhibit ovulation in 90 % of cycles .


This was a randomized dose-finding parallel group clinical trial .


Fifty-five healthy women with normal ovulation at baseline were randomized to receive a low-dose ( 1500 g/day ) or a high-dose ( 2500 g/day ) UPA-CVR for two consecutive 12-week treatment periods , followed by a recovery cycle .


A subgroup of women received levonorgestrel ( LNG ) 1.5 mg orally twice ( at the end of both 12-week ring periods ) or once ( at the end of the 24-week treatment ) .


The primary outcome was ovulation suppression assessed by transvaginal ultrasound and hormone levels .


Secondary outcomes included endometrial safety and bleeding patterns .


All subjects showed normal ovulation at baseline and recovery .


Ovulation suppression was seen in 81.8 % ( 95 % CI : 73.3 % , 88.5 % ) and 86.1 % ( 95 % CI : 78.1 % , 92 % ) of treatment cycles with low and high-dose , respectively .


Benign progesterone receptor modulator associated endometrial changes ( PAEC ) were seen during treatment ; 78.8 % at week 24 , but resolved at recovery cycle .


A few cases of heavy bleeding occurred near the end of the 24-week treatment , but a single dose of LNG every 12 weeks reduced the increase in endometrial thickness during the second treatment period and prevented excessive bleeding .


The 3-month UPA-CVR may become an effective long-acting , user-controlled estrogen-free contraceptive .


The greatest suppression of ovulation was seen with the 2500-g/day ring .


The 3-month CVR delivering UPA 2500 g/day can become an effective user-controlled estrogen-free contraceptive method .


Benign PAEC during treatment returns to normal after discontinuation .


The prevention of occasional excessive withdrawal bleeding , either by a progestin or by using higher UPA levels to increase follicle suppression may permit prolonged treatment .


Docetaxel/cisplatin/infusional 5-fluorouracil ( 5-FU ; DCF ) is a standard chemotherapy regimen for patients with advanced gastric cancer ( GC ) .


This phase II study evaluated docetaxel/oxaliplatin ( TE ) , docetaxel/oxaliplatin/5-FU ( TEF ) , and docetaxel/oxaliplatin/capecitabine ( TEX ) in patients with advanced GC .


Patients with metastatic or locally recurrent gastric adenocarcinoma ( including carcinoma of the gastro-oesophageal junction ) were randomly assigned ( 1 : 1 : 1 ) to TE , TEF , or TEX. .


Each regimen was tested at two doses before full evaluation at optimized dose levels .


The primary end point was progression-free survival ( PFS ) .


Overall survival ( OS ) , tumour response , and safety were also assessed .


A therapeutic index ( median PFS relative to the incidence of febrile neutropenia ) was calculated for each regimen and compared with DCF ( historical data ) .


Overall , 248 patients were randomly assigned to receive optimized dose treatment .


Median PFS was longer with TEF ( 7.66 [ 95 % confidence interval ( CI ) : 6.97-9 .40 ] months ) versus TE ( 4.50 [ 3.68-5 .32 ] months ) and TEX ( 5.55 [ 4.30-6 .37 ] months ) .


Median OS was 14.59 ( 95 % CI : 11.70-21 .78 ) months for TEF versus 8.97 ( 7.79-10 .87 ) months for TE and 11.30 ( 8.08-14 .03 ) months for TEX. .


The rate of tumour response ( complete or partial ) was 46.6 % ( 95 % CI 35.9-57 .5 ) for TEF versus 23.1 % ( 14.3-34 .0 ) for TE and 25.6 % ( 16.6-36 .4 ) for TEX. .


The frequency and type of adverse events ( AEs ) were similar across the three arms .


Common grade 3/4 AEs were fatigue ( 21 % ) , sensory neuropathy ( 14 % ) , and diarrhoea ( 13 % ) .


Febrile neutropenia was reported in 2 % ( TEF ) , 14 % ( TE ) , and 9 % ( TEX ) of patients .


The therapeutic index was improved with TEF versus TEX , TE , or DCF .


These results suggest that TEF is worthy of evaluation as an arm in a phase III trial or as a backbone regimen for new targeted agents in advanced GC .


CLINICALTRIALS.GOV : Identifier Trial registration number : NCT00382720 .


Procollagen 1 amino-terminal propeptide ( P1NP ) is a bone formation marker and has been shown to have a strong association with the extent of bone metastases ( BM ) in patients with advanced prostate cancer .


More recently , its levels were found to be affected by androgen deprivation therapies and bisphosphonates .


We investigated the role of P1NP as a surrogate marker of sub-radiological skeletal metastases in prostate cancer patients with biochemical failure ( BF ) .


BePrepared is a prospective longitudinal substudy of RADAR trial in which serial P1NPs were collected at regular intervals for 123 patients who had completed RADAR protocol treatment .


There was no trend identified in P1NP levels prior to diagnosis of BM .


We found that there was no difference in P1NP concentrations at the time of diagnosis of BM in the group that developed BM compared with P1NP levels in groups with only nodal metastases or BF .


In the group of patients who did not experience BF , P1NP was affected by previous luteinizing hormone-releasing hormone-agonist and bisphosphonate therapy .


Hence , patients who received an 18-month course of androgen deprivation without bisphosphonates had significantly higher P1NP values than patients with shorter androgen deprivation therapy ( ADT ) course combined with a course of bisphosphonates .


P1NP is not a sensitive serum marker of early BM in high-risk prostate cancer patients with BF and low prostate-specific antigen levels as its levels are affected by prior history of bone remodelling therapies such as ADT and bisphosphonates .


Postmenopausal bone loss can be exacerbated by environmental contaminants , including the heavy metal cadmium ( Cd ) .


We hypothesized that incorporating phosphorus ( P ) into the diet would lead to the chelation of Cd into P , preventing its absorption and subsequent bone loss .


To test this hypothesis , we used ovariectomized rats as a model of postmenopausal osteoporosis to examine the deleterious effects of Cd on bone with and without added P. Fifty 3-month-old ovariectomized Sprague-Dawley rats were assigned to five treatment groups ( n = 10 per group ) for 3 months as follows : ( 1 ) control ; ( 2 ) 50 ppm Cd ; ( 3 ) 50 ppm Cd plus 1.2 % P ; ( 4 ) 200 ppm Cd ; and ( 5 ) 200 ppm Cd plus 1.2 % P.


Cd plus P caused a significant loss of whole body ( P = 0.0001 and P < 0.001 ) and femoral ( P = 0.0005 and P < 0.001 ) bone mineral density ( BMD ) and bone mineral content , respectively , and a loss of fourth lumbar vertebra BMD and bone mineral content ( P < 0.0001 and P < 0.001 , respectively ) .


Nonetheless , 200 ppm Cd plus 1.2 % P had the most deleterious effects on whole body and femoral BMD .


For femoral neck microstructural properties , 50 ppm Cd plus 1.2 % P caused an increase in trabecular separation , whereas 200 ppm Cd plus 1.2 % P caused a decrease in bone volume-to-total volume ratio , a decrease in trabecular number , and an increase in trabecular separation and structural model index .


Our findings indicate that Cd exposure , along with high intake of P , may be a public health hazard with respect to bone health .


To evaluate the clinical efficacy and safety of integrative medical program based on blood cooling and detoxification recipe ( BCDR ) in treating patients with hepatitis B virus related acute-on-chronic liver failure ( HBV-ACLF ) of heat-toxicity accumulation syndrome ( HTAS ) .


Adopting randomized controlled clinical design , a total of 105 HBV-ACLF patients of HTAS were randomly assigned to the trial group ( 64 cases ) and the control group ( 41 cases ) .


Patients in the control group were treated with comprehensive Western therapy , while those in the trial group were treated with comprehensive Western therapy plus BCDR .


All were treated for 8 weeks and followed up for 40 weeks .


Effect and safety of the treatment were assessed , including fatality , liver functions [ total bilirubin ( TBIL ) , albumin ( ALB ) , alanine aminotransferase ( ALT ) , and aspartate transaminase ( AST ) ] , and prothrombin activity ( PTA ) after treatment and at week 48 of follow-ups .


After 8-week treatment , there was statistical difference in the overall fatality rate ( 15.63 % vs 34.15 % ) , the fatality rate in the mid-term ( 25.0 % vs 64.7 % ) , TBIL at week 8 ( 64.54 + / - 79.75 ) , AST [ at week 2 : ( 178.97 + / - 44.24 ) U/L vs ( 288.48 + / - 58.49 ) U/L ; at week 4 : ( 61.65 + / - 27.36 ) U/L vs ( 171.12 + / - 89.11 ) U/L ] and PTA [ at week 4 : ( 58.30 + / - 15.29 ) vs ( 42.56 + / - 15.27 ) ; at week 6 : ( 60.77 + / - 20.40 ) vs ( 43.08 + / - 12.79 ) ] ( all P < 0.05 ) .


At week 48 of the followup , the fatality rate of the trial group ( 21.88 % ) decreased by 17.14 % when compared with that of the control group ( 39.02 % ; P < 0.05 ) .


No obvious adverse event occurred in the two groups during the 8-week treatment period .


BCDR could significantly reduce the mortality of HBV-ACLF patients .


This study was conducted for the nutritional assessment of cancer patients undergoing radiotherapy ( RT ) and to investigate the changes in nutrition status , oral intake , morbidity and quality of life ( QOL ) in cancer patients after intensive nutrition counseling .


Eighty-seven cancer patients were randomized to either a nutrition counseling group ( n = 44 , age 58.02.2 years ) or a control group ( n = 43 , 62.01.8 years ) .


Nutrition counseling accompanied RT , and the subjects received at least three sessions of individualized dietary counseling over the duration of RT. .


Assessment parameters were nutritional intake ( 24-h recall method ) , nutritional status Patient-Generated Subjective Global Assessment ( PG-SGA ) , QOL and blood parameters including albumin .


All parameters were measured at baseline , at the end of RT , and 1 month after the termination of RT. .


Body weight , body mass index ( BMI ) , and energy and protein intake for the intervention and control groups did not differ significantly between baseline and the end of RT. .


However , at 1 month follow-up , protein intake was significantly decreased in the control group ( p < 0.05 ) .


Blood albumin , total protein ( TP ) , total lymphocyte count ( TLC ) were not different between the two groups .


According to PG-SGA stage , at 1 month follow-up , patients in the intervention group showed increased number of patients with stage A status ( well nourished ) .


In addition , insomnia and nausea was significantly improved in the intervention group assessed by QOL .


We suggest that repetitive and intensive nutritional counseling is necessary to improve QOL and to prevent deterioration of nutritional status in cancer patients receiving RT. .


Gentamicin is an aminoglycoside antibiotic that is highly effective in treating Gram-negative infections , but inappropriate use leads to toxicity .


In 2010 , the Australian Therapeutic Guidelines ( Antibiotic ) were revised to recommend the use of computerised methods to individualise dosing of gentamicin and optimise therapy , rather than traditional nomogram approaches .


To determine whether gentamicin prescribing was compliant with the Australian Therapeutic Guidelines , version 14 ( 2010 ) in a setting where computerised dose recommendation resources and computerised decision support were available , and to determine why the resources were effective or ineffective in achieving compliance to guidelines .


During phase 1 , a retrospective audit of gentamicin prescribing from 1 January 2012 to 31 December 2012 ( n = 826 ) at a 320-bed teaching hospital in Sydney was undertaken .


In phase 2 , 12 doctors from specialties with high-volume prescribing of gentamicin were interviewed .


Intravenous gentamicin was used in 545 cases , 81 % of which were for short-term therapy ( 48h ) .


Doctors feared inducing toxicity in patients , but limited the dose rather than altering the dosing interval according to renal function .


Of the ` continued ' dosing cases , 55 % went unmonitored and the computerised dose recommendation service was rarely used .


Doctors were unaware of its availability despite electronic alerts accompanying prescriptions of gentamicin .


In comparison with the national guidelines , there was significant under-dosing and monitoring practices were haphazard .


Computerised electronic alerts were ineffective in informing users .


To improve prescribing practices , we recommend exploring alternative computerised decision support approaches ( e.g. pre-written orders ) and more pervasive and persuasive implementation strategies .


The construction of a colostomy is a common procedure , but the evidence for the different parts of the construction of the colostomy is lacking .


Parastomal hernia is a common complication of colostomy formation .


The aim of this study is to standardise the colostomy formation and to compare three types of colostomy formation ( one including a mesh ) regarding the development of parastomal hernia .


Stoma-Const is a Scandinavian randomised trial comparing three types of colostomy formation .


The primary endpoint is parastomal herniation as shown by clinical examination or CT scan within one year .


Secondary endpoints are re-admission rate , postoperative complications ( classified according to Clavien-Dindo ) , stoma-related complications ( registered in the case record form at stoma care nurse follow-up ) , total length of hospital stay during 12months , health-related quality of life and health economic analysis as well as re-operation rate and mortality within 30days and 12months of primary surgery .


Follow-up is scheduled at 4-6 weeks , and 6 and 12months .


Inclusion is set at 240 patients .


Parastomal hernia is a common complication after colostomy formation .


Several studies have been performed with the aim to reduce the rate of this complication .


However , none are fully conclusive and data on quality of life and health economy are lacking .


The aim of this study is to develop new standardised techniques for colostomy formation and evaluate this with patient reported outcomes as well as clinical and radiological assessment .


Clinicaltrials.gov , NCT01694238.2012-09-24 .


Zonisamide has been associated with weight loss in children and adults .


To assess the effects of adjunctive zonisamide on weight and body mass index ( BMI ) in children with partial epilepsy .


A subanalysis was conducted of a Phase III trial and extension study , in which children with partial epilepsy received adjunctive zonisamide ( target dose 8 mg/kg/day ; maximum 500 mg/day ) .


Changes in weight were correlated with skeletal development and sexual maturation .


Overall , 179 children ( 93 male , 86 female ; age 6-18 years ) received zonisamide ( mean duration 370.6 days ) .


Weight loss 5 % was reported for 64 of 179 ( 35.8 % ) zonisamide-treated children .


Of these , 46.9 % were overweight/obese at study entry , compared with 23.4 % at study end ( P = 0.0007 ) ; 48.4 % had normal weight at study entry , compared with 65.6 % at study end ( P = 0.03 ) .


Three patients were underweight at study entry , and four more became underweight by study end .


No consistent correlations between weight loss and skeletal development or sexual maturation were observed .


Approximately one-third of children treated with zonisamide experienced 5 % weight loss .


Weight loss was most apparent in children with high baseline BMI values and did not appear to be associated with any consistent effects on growth and development .


A multi-center large scale study is needed to confirm the efficacy and safety of domestic peritoneal dialysis ( PD ) solutions .


Some researchers believe that 6 L/d is enough for adequate dialysis , but there is no multi-center prospective study on Chinese population to confirm this .


In this study , we evaluated the efficacy and safety of domestic PD solution ( Changfu ) and its difference between 6 L and 8 L dosage .


Adult PD patients who had taken PD therapy for at least one month were selected and divided into four groups according to two dialysis solution brands and two dialysis dosages , i.e. , 6 L dose with Changfu dialysis solution , 6 L dose with Baxter dialysis solution , 8 L dose with Changfu dialysis solution , and 8 L dose with Baxter dialysis solution .


After 48 weeks , the changes of primary and secondary efficacy indices were compared between different types and different dosages .


We also analyzed the changes of safety indices .


Changes of Kt/V from baseline to 48 weeks between Changfu and Baxter showed no statistical differences ; so did those of creatinine clearance rate ( Ccr ) .


Normalized protein catabolic rate ( nPCR ) from baseline to 48 weeks between Changfu and Baxter showed no statistical differences ; so did those of net ultrafiltration volume ( nUF ) and estimated glomerular filtration rate ( eGFR ) .


Changes of nPCR from baseline to 48 weeks between 6 L and 8 L showed no statistical differences ; so did those of nUF and eGFR .


The decline of Kt/V from baseline to 48 weeks in 6 L group was more than that in 8 L group .


Change of Ccr was similar .


During the 48-week period , the mean Kt/V was above 1.7 / w , and mean Ccr was above 50 L1 .73 m ( -2 ) w ( -1 ) .


More adverse events were found in Changfu group before Changfu Corporation commenced technology optimization , and the statistical differences disappeared after that .


The domestic PD solution ( Changfu ) was proven to be as effective as Baxter dialysis solution .


During 48-week period , a dosage of 6 L/d was enough for these patients to reach adequate PD .


Clinical study promotes technological optimization , further helps to improve the safety indices of the medical products .


To assess and compare efficacy , pain , and the learning curve associated with diagnostic therapeutic hysteroscopy using mechanical tissue removal versus bipolar electrical resection in the management of endometrial polyps in an ambulatory care setting .


A randomized controlled clinical trial ( Canadian Task Force classification I ) .


Hospital de Igulada , Barcelona , Spain .


A total of 133 patients diagnosed with endometrial polyp ( s ) were included and randomly assigned to 1 of the 2 hysteroscopic methods .


Criteria assessed were total hysteroscopy time , full polypectomy procedure time , pain experienced by patients , and learning curve of staff in training .


The average time to perform total hysteroscopy using the mechanical tissue removal system ( TRUCLEAR 5.0 System ; Smith & Nephew Inc. , Andover , MD ) was 6 minutes 49 seconds versus 11 minutes 37 seconds required for the bipolar electrosurgery system ( GYNECARE VERSAPOINT ; Ethicon Inc , Somerville , NJ ) ( p < .01 ) .


Results for complete polypectomy time favored the TRUCLEAR System at 3 minutes 7 seconds over the VERSAPOINT System at 8 minutes 25 seconds ( p < .01 ) .


If a successful procedure is predicated on access to cavity , visualization , and complete resection and excision of endometrial polyp , the mechanical TRUCLEAR Tissue Removal System shows a higher success rate than the VERSAPOINT Bipolar Electrosurgery System at 92 % and 77 % , respectively .


Analysis of pain using the visual analog scale revealed no significant differences between the 2 techniques ( p > .05 ) .


A study of the residents ' learning curve showed a higher level of autonomy with hysteroscopy using the TRUCLEAR Tissue Removal System with which residents showed a higher level of confidence compared with hysteroscopy with the VERSAPOINT Bipolar Electrosurgery System .


In hysteroscopic polypectomy , the mechanical tissue removal system was significantly faster , achieved a greater success rate for complete polypectomy , and required a shorter learning curve from staff being trained in the management of endometrial polyps when compared with bipolar electrical resection .


Complicated skin and skin structure infections ( cSSSIs ) are characterized by infections with gram-positive or gram-negative aerobic or anaerobic bacteria , as well as by a polymicrobial etiology .


These invading microorganisms are recognized by pattern-recognition receptors ( PRRs ) of the innate immune system .


This study assessed whether genetic variation in genes encoding PRRs influences the susceptibility to cSSSIs .


A total of 318 patients with cSSSI and 328 healthy controls were genotyped for 9 nonsynonymous single-nucleotide polymorphisms ( SNPs ) in PRR genes coding for Toll-like receptors ( TLRs ) 1 , 2 , 4 , and 6 ; NOD-like receptor 2 ; and the signaling adaptor molecule TIRAP .


Associations between susceptibility to cSSSIs and a SNP were investigated by means of logistic regression models .


In an additional cohort of 74 healthy individuals in whom the same SNPs were genotyped , peripheral blood mononuclear cells ( PBMCs ) were obtained and stimulated with Staphylococcus aureus .


Interleukin 6 concentrations were determined in supernatants by enzyme-linked immunosorbent assay to determine the correlation between genotypes and levels of IL-6 secretion .


In the genetic association analysis , polymorphisms in TLR1 ( S248N and R80T ) , TLR2 ( P631H ) , and TLR6 ( P249S ) were associated with an increased susceptibility to cSSSIs .


No association with susceptibility to cSSSIs was observed for polymorphisms TLR2 ( R753Q ) , TLR4 ( D299G and T399I ) , NOD2 ( P268S ) , and TIRAP ( S180L ) .


In the functional analysis , individuals bearing the TLR1 248N or 80T allele showed lower IL-6 secretion upon stimulation with S. aureus .


Polymorphisms in TLR1 , TLR2 , and TLR6 are associated with increased susceptibility to cSSSIs .


For TLR1 , impaired proinflammatory cytokine production due to the polymorphism is most likely the mechanism mediating this effect .


Cognitive benefits of multivitamins have been observed in the elderly , but fewer trials have investigated younger , healthy cohorts .


This randomised , double-blind , placebo-controlled study investigated the cognitive effects of 16-week multivitamin supplementation in adults aged 20-49years .


A total of 138 participants aged 20-50years were randomised and 116 completed the trial .


The participants completed a computerised battery of cognitive tasks before and after 16-week supplementation with a multivitamin containing minerals and herbs or placebo .


Blood measures of homocysteine , vitamin B6 , B12 and folate were collected at both time points .


In men , there was a strong trend ( p = 0.01 ; which did not reach significance when adjusted for multiple comparisons ) for the multivitamin to improve performance on the incongruent stroop task , a measure of selective attention and response inhibition .


There were no cognitive benefits of multivitamin supplements in women .


Multivitamin supplementation substantially increased blood levels of vitamin B6 , B12 and folate in both genders and decreased homocysteine in men .


In men who received the multivitamin , improved stroop congruent performance was associated with increased vitamin B6 levels .


Multivitamin supplementation may be useful for maintaining levels of B vitamins .


The effects of multivitamins on speeded attention such as the stroop task in young adults warrant further investigation .


Current cognitive behavioral models of hoarding view hoarding as a multifaceted problem stemming from various information processing deficits .


However , there is also reason to suspect that the consequences of hoarding may in turn impact or modulate deficits in information processing .


The current study sought to expand upon the existing literature by manipulating clutter to examine whether the presence of a cluttered environment affects information processing .


Participants included 34 individuals with hoarding disorder .


Participants were randomized into a clutter or non-clutter condition and asked to complete various neuropsychological tasks of memory and attention .


Results revealed that hoarding severity was associated with difficulties in sustained attention .


However , individuals in the clutter condition relative to the non-clutter condition did not experience greater deficits in information processing .


Limitations include the cross-sectional design and small sample size .


The current findings add considerably to a growing body of literature on the relationships between information processing deficits and hoarding behaviors .


Research of this type is integral to understanding the etiology and maintenance of hoarding .


To evaluate the safety and efficacy of methazolamide as a potential therapy for type 2 diabetes .


This double-blind , placebo-controlled study randomized 76 patients to oral methazolamide ( 40 mg b.i.d. ) or placebo for 24 weeks .


The primary efficacy end point for methazolamide treatment was a placebo-corrected reduction in HbA1c from baseline after 24 weeks ( HbA1c ) .


Mean SD baseline HbA1c was 7.1 0.7 % ( 54 5 mmol/mol ; n = 37 ) and 7.4 0.6 % ( 57 5 mmol/mol ; n = 39 ) in the methazolamide and placebo groups , respectively .


Methazolamide treatment was associated with a HbA1c of -0.39 % ( 95 % CI -0.82 , 0.04 ; P < 0.05 ) ( -4.3 mmol/mol [ -9.0 , 0.4 ] ) , an increase in the proportion of patients achieving HbA1c 6.5 % ( 48 mmol/mol ) from 8 to 33 % , a rapid reduction in alanine aminotransferase ( 10 units/L ) , and weight loss ( 2 % ) in metformin-cotreated patients .


Methazolamide is the archetype for a new intervention in type 2 diabetes with clinical benefits beyond glucose control .


Although procedural sedation using intravenous agents is highly effective for forearm fracture reduction , the process is both resource and time intensive .


Our objective was to determine whether the use of a hematoma block as an adjunct to procedural sedation with ketamine and midazolam reduces ( 1 ) pain during the procedure ( scored using the Observational Score for Behavioral Distress-Revised score ) or ( 2 ) the excess sedation time , defined by the time between procedure completion and discharge from sedation .


Our secondary outcome measure was total ketamine dose administered during the procedure .


A randomized , double-blind , placebo-controlled clinical trial was conducted .


Before fracture reduction , children 3 to 17 years of age randomly received 2 % lidocaine ( L ) or normal saline ( NS ) into the hematoma of their fracture site during sedation with intravenous ketamine and midazolam .


Ninety patients were randomized : 50 to L and 40 to NS .


The groups were similar with regard to age , sex , type of fracture , and prior administration of pain medication .


Median Observational Score for Behavioral Distress-Revised scores were 1.11 and 1.69 for the L and NS groups , respectively ( P = 0.23 ) .


Excess sedation time was not significantly different between the groups ( P = 0.36 ) , with a median excess sedation time of 33.0 and 36.0 minutes for the L and NS groups , respectively .


Mean ketamine dose administered was not different between the groups ( P = 0.42 ) .


The mean total dose administered was 1.00 mg/kg and 1.07 mg/kg in the L and NS groups , respectively .


Mean midazolam dose was 0.05 mg/kg for both groups .


The use of a hematoma block as an adjunct to procedural sedation with ketamine and midazolam for forearm fracture reduction conferred no additional benefit and did not decrease observed pain scores , excess sedation time , or total ketamine dose administered .


This study assessed the safety , tolerability , and pharmacodynamics of emixustat hydrochloride ( ACU-4429 ) , a novel visual cycle modulator , in subjects with geographic atrophy associated with dry age-related macular degeneration .


Subjects were randomly assigned to oral emixustat ( 2 , 5 , 7 , or 10 mg once daily ) or placebo ( 3:1 ratio ) for 90 days .


Recovery of rod photoreceptor sensitivity after a photobleach was measured by electroretinography .


Safety evaluations included analysis of adverse events and ophthalmic examinations .


Seventy-two subjects ( 54 emixustat and 18 placebo ) were evaluated .


Emixustat suppressed rod photoreceptor sensitivity in a dose-dependent manner .


Suppression plateaued by Day 14 and was reversible within 7 days to 14 days after drug cessation .


Most systemic adverse events were not considered treatment related .


Dose-related ocular adverse events ( chromatopsia , 57 % emixustat vs. 17 % placebo and delayed dark adaptation , 48 % emixustat vs. 6 % placebo ) were mild to moderate in severity , and the majority resolved on study or within 7 days to 14 days after study drug cessation .


Reversibility of these adverse events with long-term administration , however , is undetermined .


In this Phase II study , emixustat produced a dose-dependent reversible effect on rod function that is consistent with the proposed mechanism of action .


These results support further testing of emixustat for the treatment of geographic atrophy associated with dry age-related macular degeneration .


Various surgical meshes are used in the repair of inguinal hernia and are associated with numerous complications .


Our main objective in this study was to determine whether a biologic hernia matrix is equivalent to polypropylene mesh in an open inguinal hernia repair using the Lichtenstein technique .


A prospective , randomized , double-blinded , single-center trial was conducted to evaluate the efficacy of a biologic Inguinal Hernia Matrix ( IHM ; Cook Medical ) compared with polypropylene ( PP ) mesh using Lichtenstein 's inguinal hernia repair in a 3-year outcomes study .


Patients were evaluated for recurrence and complications by a blinded surgeon at 2 weeks , 3 months , 6 months , and 1 year post procedure .


Patient demographics , including comorbidities and nutrition status , were recorded .


Intraoperative information including hernia type and location , procedure time , level of difficulty , degree of surgeon frustration , and surgical experience were collected .


One hundred male patients provided informed consent and were randomized into the study in a 1:1 fashion .


There were no significant differences in degree of difficulty and level of frustration between the 2 groups .


At 1-year follow-up , 3 recurrences were diagnosed in the IHM group as compared with none in the PP group ( p = 0.11 ) .


Persistent pain trended higher in the PP group ( 6 % vs 4 % ) .


All 3 recurrences occurred in the direct inguinal hernia group and were performed by attendings in the first year post training ( 3 different attendings ) .


No recurrences occurred in patients operated on by more senior surgeons .


The IHM hernioplasty compares favorably with PP mesh at 1-year follow-up with similar recurrence rates and complications .


Surgeon experience appears to be a major factor affecting successful outcomes .


The authors compared the effectiveness of 50 sessions of schema therapy with clarification-oriented psychotherapy and with treatment as usual among patients with cluster C , paranoid , histrionic , or narcissistic personality disorder .


A multicenter randomized controlled trial , with a single-blind parallel design , was conducted between 2006 and 2011 in 12 Dutch mental health institutes .


A total of 323 patients with personality disorders were randomly assigned ( schema therapy , N = 147 ; treatment as usual , N = 135 ; clarification-oriented psychotherapy , N = 41 ) .


There were two cohorts of schema therapy therapists , with the first trained primarily with lectures and the second primarily with exercises .


The primary outcome was recovery from personality disorder 3 years after treatment started ( assessed by blinded interviewers ) .


Secondary outcomes were dropout rates and measures of personality disorder traits , depressive and anxiety disorders , general psychological complaints , general and social functioning , self-ideal discrepancy , and quality of life .


A significantly greater proportion of patients recovered in schema therapy compared with treatment as usual and clarification-oriented psychotherapy .


Second-cohort schema therapists had better results than first-cohort therapists .


Clarification-oriented psychotherapy and treatment as usual did not differ .


Findings did not vary with specific personality disorder diagnosis .


Dropout was lower in the schema therapy and clarification-oriented psychotherapy conditions .


All treatments showed improvements on secondary outcomes .


Schema therapy patients had less depressive disorder and higher general and social functioning at follow-up .


While interview-based measures demonstrated significant differences between treatments , differences were not found with self-report measures .


Schema therapy was superior to treatment as usual on recovery , other interview-based outcomes , and dropout .


Exercise-based schema therapy training was superior to lecture-based training .


To reduce the incidence of incisional hernia ( IH ) in colorectal surgery by implanting a mesh on the overlay position .


The incidence of IH in colorectal surgery may be as high as 40 % .


IH causes severe health and cosmetic problems , and its repair increases health care costs .


Randomized , controlled , prospective trial .


Patients undergoing any colorectal procedure ( both elective and emergency ) through a midline laparotomy were divided into 2 groups .


The abdomen was closed with an identical technique in both groups , except for the implantation of an overlay large-pore polypropylene mesh in the study group .


Patients were followed up clinically and radiologically for 24 months .


A total of 107 patients were included : 53 in the study group and 54 in the control group .


Both groups were homogeneous , except for a higher incidence of diabetes in the mesh group .


There were 20 emergency procedures in the study group and 17 in the control group .


There were no statistical differences in surgical site infections , seromas , or mortality between the groups ( 33.3 % , 13.8 % , and 3.7 % in the control group and 18.9 % , 13.2 % , and 3.8 % in the study group ) .


No mesh rejection was reported .


The incidence of IH was 17 of 54 ( 31.5 % ) in the control group and 6 of 53 ( 11.3 % ) in the study group ( P = 0.011 ) .


The incidence of IH is high in patients undergoing elective or emergency surgery for colorectal diseases .


The addition of a prophylactic large-pore polypropylene mesh on the overlay position decreases the incidence of IH without adding morbidity .


The purpose of this trial was to evaluate the effect of a Web-based , self-report assessment and educational intervention on symptom distress during cancer therapy .


A total of 752 ambulatory adult participants were randomly assigned to symptom/quality-of-life ( SxQOL ) screening at four time points ( control ) versus screening , targeted education , communication coaching , and the opportunity to track/graph SxQOL over time ( intervention ) .


A summary of the participant-reported data was delivered to clinicians at each time point in both groups .


All participants used the assessment before a new therapeutic regimen , at 3 to 6 weeks and 6 to 8 weeks later , completing the final assessment at the end of therapy .


Change in Symptom Distress Scale-15 ( SDS-15 ) score from pretreatment to end of study was compared using analysis of covariance and regression analysis adjusting for selected variables .


We detected a significant difference between study groups in mean SDS-15 score change from baseline to end of study : 1.27 ( standard deviation [ SD ] , 6.7 ) in the control group ( higher distress ) versus -0.04 ( SD , 5.8 ) in the intervention group ( lower distress ) .


SDS-15 score was reduced by an estimated 1.21 ( 95 % CI , 0.23 to 2.20 ; P = .02 ) in the intervention group .


Baseline SDS-15 score ( P < .001 ) and clinical service ( P = .01 ) were predictive .


Multivariable analyses suggested an interaction between age and study group ( P = .06 ) ; in subset analysis , the benefit of intervention was strongest in those age > 50 years ( P = .002 ) .


Web-based self-care support and communication coaching added to SxQOL screening reduced symptom distress in a multicenter sample of participants with various diagnoses during and after active cancer treatment .


Participants age > 50 years , in particular , may have benefited from the intervention .


Findings from inflammatory bowel disease ( IBD ) genome-wide association studies are being translated clinically into prognostic and diagnostic indicators of disease .


Yet , patient perception and understanding of these tests and their applicability to providing risk information is unclear .


The goal of this study was to determine , using hypothetical scenarios , whether patients with IBD perceive genetic testing to be useful for risk assessment , whether genetic test results impact perceived control , and whether low genetic literacy may be a barrier to patient understanding of these tests .


Two hundred fifty seven patients with IBD from the Johns Hopkins gastroenterology clinics were randomized to receive a vignette depicting either a genetic testing scenario or a standard blood testing scenario .


Participants were asked questions about the vignette and responses were compared between groups .


Perceptions of test utility for risk assessment were higher among participants responding to the genetic vignette ( P < 0.001 ) .


There were no significant differences in perceptions of control over IBD after hypothetical testing between vignettes ( P = 0.24 ) .


Participant responses were modified by genetic literacy , measured using a scale developed for this study .


Participants randomized to the genetic vignette who scored higher on the genetic literacy scale perceived greater utility of testing for risk assessment ( P = 0.008 ) and more control after testing ( P = 0.02 ) .


Patients with IBD perceive utility in genetic testing for providing information relevant to family members , and this appreciation is promoted by genetic literacy .


Low genetic literacy among patients poses a potential threat to effective translation of genetic and genomic tests .


Recent epidemiological studies revealed a striking inverse relationship between vitamin D levels , glucose intolerance/insulin resistance ( IR ) , and cardiovascular disease .


However , few interventional studies have evaluated the effect of vitamin D supplementation on cardiovascular risk , such as IR and arterial stiffness , in diabetes .


We investigated the role of vitamin D supplementation on cardiovascular risk in type 2 diabetes patients , including metabolic parameters , IR , and arterial stiffness .


We enrolled patients who were taking antidiabetic medications or managed their diabetes using lifestyle changes .


We excluded patients who were taking vitamin D or calcium supplements .


We randomized participants into the vitamin D group ( cholecalciferol 2,000 IU/day + calcium 200 mg/day , n = 40 ) or the placebo group ( calcium 200 mg/day , n = 41 ) .


We compared their IR ( homeostasis model of assessment [ HOMA ] - IR ) and arterial stiffness ( brachial-ankle pulse wave velocity and radial augmentation index ) before and after 24 weeks of intervention .


The baseline characteristics of the two groups were similar .


A total of 62 participants ( placebo , 30 ; vitamin D , 32 ) completed the study protocol .


At the end of the study period , the 25-hydroxyvitamin D [ 25 ( OH ) D ] levels were significantly higher in the vitamin D group than in the placebo group ( 35.4 8.5 ng/mL vs. 18.4 7.3 ng/mL , p < 0.001 ) .


There was no difference in HOMA-IR or changes in arterial stiffness ( placebo , 21 , vitamin D , 24 ) between the groups .


Our data suggest that high-dose vitamin D supplementation might be effective in terms of elevating 25 ( OH ) D levels .


However , we identified no beneficial effects on cardiovascular risk in type 2 diabetes , including IR and arterial stiffness .


To determine the efficacy and safety of Curcuma domestica extracts in pain reduction and functional improvement .


367 primary knee osteoarthritis patients with a pain score of 5 or higher were randomized to receive ibuprofen 1,200 mg/day or C. domestica extracts 1,500 mg/day for 4 weeks .


The main outcomes were Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) total , WOMAC pain , WOMAC stiffness , and WOMAC function scores .


Adverse events ( AEs ) were also recorded .


185 and 182 patients were randomly assigned into C. domestica extracts and ibuprofen groups , respectively .


The baseline characteristics were no different between groups .


The mean of all WOMAC scores at weeks 0 , 2 , and 4 showed significant improvement when compared with the baseline in both groups .


After using the noninferiority test , the mean difference ( 95 % confidence interval ) of WOMAC total , WOMAC pain , and WOMAC function scores at week 4 adjusted by values at week 0 of C. domestica extracts were noninferior to those for the ibuprofen group ( P = 0.010 , P = 0.018 , and P = 0.010 , respectively ) , except for the WOMAC stiffness subscale , which showed a trend toward significance ( P = 0.060 ) .


The number of patients who developed AEs was no different between groups .


However , the number of events of abdominal pain/discomfort was significantly higher in the ibuprofen group than that in the C. domestica extracts group ( P = 0.046 ) .


Most subjects ( 96 % -97 % ) were satisfied with the treatment , and two-thirds rated themselves as improved in a global assessment .


C. domestica extracts are as effective as ibuprofen for the treatment of knee osteoarthritis .


The side effect profile was similar but with fewer gastrointestinal AE reports in the C. domestica extracts group .


To evaluate the effectiveness of a prefabricated appliance and compare it to the effectiveness of a stabilization appliance in patients with temporomandibular joint ( TMJ ) pain .


This randomized , controlled multicenter study comprised 48 patients diagnosed with TMJ arthralgia according to the Research Diagnostic Criteria for Temporomandibular Disorders .


The effectiveness of a prefabricated appliance ( Relax ) , worn by half of the patients ( referred to as the R group ) , was compared to the effectiveness of a stabilization appliance , worn by the other half of patients ( S group ) .


Treatment outcome was assessed according to the recommendations by the Initiative on Methods , Measurement , and Pain Assessment in Clinical Trials ( IMMPACT ) on an intent-to-treat basis .


To analyze the differences between groups , the chi-square test and the Mann-Whitney U test were used , while the Friedman analysis of variance ( ANOVA ) on ranks was used for the analyses between baseline data and follow-up measurements , all with a significance level set at P < .05 .


There were no differences between the groups at baseline .


A 30 % reduction of pain intensity was reported by 62.5 % of the R group and 58.3 % of the S group at the 10-week follow-up ; 58 % and 50.3 % , respectively , at the 6-month follow-up ; and 41.7 % in both groups at 12 months .


At the 12-month follow-up , pain intensity had decreased and physical function had improved in both groups ( P < .005 and P < .016 , respectively ) , without significant group differences .


Emotional function ( depression and nonspecific physical symptoms ) did not change .


Overall improvement of `` better '' to `` symptom-free '' was observed in 67 % of the R group and 58 % of the S group .


No side effects occurred .


The effectiveness of the prefabricated appliance seems to be similar to that of the stabilization appliance in alleviating TMJ pain .


Since the prefabricated appliance requires only one visit for construction , it is convenient for both the general practitioner and for the patient .


Low 25-hydroxyvitamin D ( 25 ( OH ) D ) has been associated with increased HIV mortality , but prospective studies assessing treatment outcomes after combination antiretroviral therapy ( cART ) initiation in resource-limited settings are lacking .


A case-cohort study ( N = 411 ) was nested within a randomized cART trial of 1571 cART-naive adults in 8 resource-limited settings and the United States .


The primary outcome ( WHO stage 3/4 disease or death within 96 weeks of cART initiation ) was met by 192 cases , and 152 and 29 cases met secondary outcomes of virologic and immunologic failure .


We studied prevalence and risk factors for baseline low 25 ( OH ) D ( < 32 ng/mL ) and examined associated outcomes using proportional hazard models .


Low 25 ( OH ) D prevalence was 49 % and ranged from 27 % in Brazil to 78 % in Thailand .


Low 25 ( OH ) D was associated with high body mass index ( BMI ) , winter/spring season , country-race group , and lower viral load .


Baseline low 25 ( OH ) D was associated with increased risk of human immunodeficiency virus ( HIV ) progression and death ( adjusted hazard ratio ( aHR ) 2.13 ; 95 % confidence interval [ CI ] , 1.09-4 .18 ) and virologic failure ( aHR 2.42 ; 95 % CI , 1.33-4 .41 ) .


Low 25 ( OH ) D is common in diverse HIV-infected populations and is an independent risk factor for clinical and virologic failure .


Studies examining the potential benefit of vitamin D supplementation among HIV patients initiating cART are warranted .


Domestic violence and abuse ( DVA ) are associated with an increased risk of mental illness , but we know little about the mental health of female DVA survivors seeking support from domestic violence services .


Baseline data on 260 women enrolled in a randomized controlled trial of a psychological intervention for DVA survivors was analyzed .


We report prevalence of and associations between mental health status and severity of abuse at the time of recruitment .


We used logistic and normal regression models for binary and continuous outcomes , respectively .


Mental health measures used were : Clinical Outcomes in Routine Evaluation-Outcome Measure ( CORE-OM ) , Patient Health Questionnaire , Generalized Anxiety Disorder Assessment , and the Posttraumatic Diagnostic Scale ( PDS ) to measure posttraumatic stress disorder .


The Composite Abuse Scale ( CAS ) measured abuse .


Exposure to DVA was high , with a mean CAS score of 56 ( SD 34 ) .


The mean CORE-OM score was 18 ( SD 8 ) with 76 % above the clinical threshold ( 95 % confidence interval : 70-81 % ) .


Depression and anxiety levels were high , with means close to clinical thresholds , and all respondents recorded PTSD scores above the clinical threshold .


Symptoms of mental illness increased stepwise with increasing severity of DVA .


Women who have survived breast cancer have hot flushes that are `` significantly more frequent , severe , distressing , and of greater duration '' than in other women .


We compared the efficacy and safety of stellate ganglion block and pregabalin for the relief of hot flushes in breast cancer survivors .


Forty patients who were breast cancer survivors and were suffering from hot flushes to the degree that they seeked for treatment were included in the study and randomly divided into two groups : group I : ( N = 20 ) stellate ganglion block was done for the patients of this group ; and group II : ( N = 20 ) in this group , the patients received 75mg pregabalin twice daily .


In both groups self-completed daily hot flush diaries and monthly symptom questionnaires were obtained at baseline and for the following 3 months .


Our results showed that group I ( stellate ganglion block ) had significant ( P < 0.05 ) decline in the frequency of mild , moderate , very severe , and total hot flushes in comparison with group II ( pregabalin 75mg twice daily ) throughout the 3 months of follow up period .


The stellate ganglion block had superior efficacy in the management of hot flushes in breast cancer survivors .


The treatment of obesity is an increasing global health priority , yet few effective drug treatments are currently available .


The discovery of novel anti-obesity therapies could be assisted by the validation of experimental ( translational ) medicine models in healthy volunteers that assess efficacy and safety at an early stage of drug development .


The aim of this study was to examine the effects of the 5-HT2C receptor agonist meta-chlorophenylpiperazine ( mCPP ) in an experimental medicine model assessing both appetite and mood .


Using a between-subjects , double-blind , placebo-controlled design , 24 male and 24 female participants were randomly assigned to either placebo , 15 - or 30-mg mCPP treatment groups .


Lunch was eaten from a Universal Eating Monitor ( UEM ) that measured eating rate , and the participants completed the P1vital Oxford Emotional Test Battery ( ETB ) and a series of appetite and mood ratings .


mCPP reduced appetite and , in women , enhanced measures of satiation .


The drug also enhanced memory for emotional material in the word recall and recognition memory tasks of the ETB .


The results provide new insight into the effects of mCPP on appetite , satiety and memory in humans .


In addition , our data provide an illustration of the value of measuring changes in appetite and mood in healthy volunteers to determine the potential efficacy and safety of novel anti-obesity drugs .


The long-term outcomes of transcatheter aortic valve replacement ( TAVR ) in inoperable patients with severe aortic stenosis remain unknown .


In the Placement of Aortic Transcatheter Valves ( PARTNER ) study , 358 patients were randomly assigned to TAVR or standard therapy .


We report the 3-year outcomes on these patients , and the pooled outcomes for all randomly assigned inoperable patients ( n = 449 ) in PARTNER , as well , including the randomized portion of the continued access study ( n = 91 ) .


The 3-year mortality rate in the TAVR and standard therapy groups was 54.1 % and 80.9 % , respectively ( P < 0.001 ; hazard ratio , 0.53 ; 95 % confidence interval , 0.41-0 .68 ; P < 0.001 ) .


In survivors , there was significant improvement in New York Heart Association functional class sustained at 3 years .


The cumulative incidence of strokes at 3-year follow-up was 15.7 % in TAVR patients versus 5.5 % in patients undergoing standard therapy ( hazard ratio , 2.81 ; 95 % confidence interval , 1.26-6 .26 ; P = 0.012 ) ; however , the composite of death or strokes was significantly lower after TAVR versus standard therapy ( 57.4 % versus 80.9 % , P < 0.001 ; hazard ratio , 0.60 ; 95 % confidence interval , 0.46-0 .77 ; P < 0.001 ) .


Echocardiography showed a sustained increase in aortic valve area and decrease in transvalvular gradient after TAVR .


Analysis of the 449 pooled randomly assigned patients ( TAVR , n = 220 ; standard therapy , n = 229 ) demonstrated significant improvement in all-cause mortality and functional status during early and 3-year follow-up .


The results of the pooled cohort were similar to the results obtained from the pivotal PARTNER trial .


TAVR resulted in better survival and functional status in inoperable patients with severe aortic stenosis with durable hemodynamic benefit on long-term follow-up .


However , high residual mortality , even in successfully treated TAVR patients , highlights the need for more strategic patient selection .


http://www.clinicaltrials.gov .


Unique identifier : NCT00530894 .


Subjective clinical improvement does not always go hand-in-hand with right ventricular ( RV ) reverse remodeling after surgery for isolated severe tricuspid regurgitation ( TR ) .


This study aimed to evaluate the level of agreement between clinical improvement and echocardiographic RV reverse remodeling , and determine the relative prognostic powers of these 2 factors in terms of long-term prognosis for patients with isolated TR surgery .


Sixty-one consecutive patients ( 588 years ) were included .


During a median follow up of 55 months ( IQR , 36.571.5 months ) , a composite endpoint including death and admission for right heart failure was investigated .


Extents of reductions in RV end-systolic area ( RV-ESA ) and subjective clinical improvement at 6 months were examined .


There were 6 deaths and 5 admissions for right heart failure .


A reduction in RV-ESA of > 20 % effectively predicted event-free survival , with a sensitivity of 90.9 % and a specificity of 72.0 % ( AUC 0.81 , P = 0.001 ) .


With this cut-off , the agreement between a clinical and echocardiographic response was only 57.4 % ( 35 patients ) .


On Cox regression analysis , RV-ESA change emerged as the only independent predictor of event-free survival , whereas subjective clinical improvement did not .


A discrepancy between subjective and echocardiographic improvement at 6 months after isolated TR surgery was observed in 42.6 % of the patients .


Echocardiographic RV reverse remodeling , but not subjective clinical amelioration , was a strong prognosticator after surgery .


The effects of acute continuous positive airway pressure therapy on left ventricular diastolic function and functional capacity in patients with compensated systolic heart failure remain unclear .


This randomized , double-blind , placebo-controlled clinical trial included 43 patients with heart failure and a left ventricular ejection fraction < 0.50 who were in functional classes I-III according to the New York Heart Association criteria .


Twenty-three patients were assigned to continuous positive airway pressure therapy ( 10 cmH2O ) , while 20 patients received placebo with null pressure for 30 minutes .


All patients underwent a 6-minute walk test ( 6MWT ) and Doppler echocardiography before and immediately after intervention .


Clinicaltrials.gov : NCT01088854 .


The groups had similar clinical and echocardiographic baseline variables .


Variation in the diastolic function index ( e ' ) after intervention was associated with differences in the distance walked in both groups .


However , in the continuous positive airway pressure group , this difference was greater ( continuous positive airway pressure group : 6MWT = 9.44 +16.05 e ' , p = 0.002 ; sham group : 6MWT = 7.49 +5.38 e ' ; p = 0.015 ) .


There was a statistically significant interaction between e ' index variation and continuous positive airway pressure for the improvement of functional capacity ( p = 0.020 ) .


Continuous positive airway pressure does not acurately change the echocardiographic indexes of left ventricle systolic or diastolic function in patients with compensated systolic heart failure .


However , 30-minute continuous positive airway pressure therapy appears to have an effect on left ventricular diastolic function by increasing functional capacity .


To explore if cognitive impairment in relapsing-remitting multiple sclerosis ( RRMS ) is associated with abnormal neural function and if there is evidence of neural compensatory mechanisms .


Seventy-two RRMS patients and 89 healthy control subjects were included in a cross-sectional study .


Event-related brain potential ( P300 ) and response time ( RT ) were recorded with visual and auditory choice reaction tasks .


Cognitive function was evaluated with an 18 item test battery .


Patients had a decrease in cognitive function ( p < 0.001 for global score ) and increased visual P300 amplitude frontally .


P300 amplitude was normal in other brain areas and RT was normal .


P300 latency was normal except for an increase in auditory latency occipitally .


Cognitive performance correlated positively with parietal P300 amplitude in patients but not in controls .


Cognition had stronger correlation ( negative ) with RT in patients than in controls .


Patients with low P300 amplitude and long RT were more often cognitively impaired .


This indicates that general factors such as signal amplitude and speed are limiting for cognitive function in RRMS patients .


The increase in frontal P300 amplitude may be a compensatory effect .


Our findings suggest that high amplitude and fast speed may be protective against cognitive impairment .


To investigate the sedative and clinical effects of the pharmacopuncture with xylazine , compared to the conventional dose of a intramuscular injection in dogs .


Twelve dogs were randomly distributed in two groups of six animals and treated as follows : control group ( X-IM ) : 1mg kg ( -1 ) of xylazine given intramuscularly ( IM ) ; pharmacopuncture group ( X-Yintang ) : 0.1 mg kg ( -1 ) of xylazine diluted to 0.5 mL of saline injected into the Yin Tang acupoint .


Heart rate , cardiac rhythm ( ECG ) , systolic arterial blood pressure ( SABP ) , respiratory rate ( RR ) , rectal temperature ( RT ) , blood glucose concentration , degree of sedation and adverse effects were evaluated .


Sedative effect was observed in both groups .


The degree of sedation was greater in X-IM only at 15 min when compared with X-Yintang group .


Cardiovascular established was observed in X-Yintang group , while marked reduction in the HR and increased incidence of ECG abnormalities were detected in X-IM .


In both treatment groups , minimal changes were observed in relation to SABP , RR , RT and blood glucose .


High incidence ( 66 % ) of vomiting was observed in X-IM , while this adverse effect was absent in X-Yintang .


Pharmacopuncture with xylazine induced clinically relevant sedative effects in dogs , with the advantage of reduction of undesirable side effects associated with 2-agonists , including bradycardia , cardiac arrhythmias , and emesis .


Poor adherence to inhaled corticosteroids ( ICS ) is a critical risk factor contributing to asthma morbidity among low-income minority adolescents .


This trial tested whether peer support group meetings and peer asthma messages delivered via mp3 players improved adherence to ICS .


Low-income African American and/or Hispanic adolescents , ages 11-16 years old , with persistent asthma , and poor ( 48 % ) adherence to prescription ICS during the 3-week run-in were randomized to intervention or attention control groups ( ATG ) for the 10-week treatment .


During treatment , the intervention arm subjects participated in weekly coping peer group support sessions and received mp3 peer-recorded asthma messages that promoted adherence .


The ATG participated in weekly meetings with a research assistant and received an equivalent number of mp3 physician-recorded asthma messages .


Adherence was measured by using self-report and the Doser CT , an electronic dose counter .


The primary outcome was the difference in adherence at 10 weeks between the 2 arms .


Thirty-four subjects were randomized to each arm .


At 10 weeks , no statistical difference in objectively measured adherence could be detected between the 2 arms when adjusting for baseline adherence ( P = .929 ) .


Adherence declined in both groups over the course of the active treatment period .


In both study arms , self-reported adherence by participants was significantly higher than their objectively measured adherence at week 10 ( P < .0001 ) .


Improving medication adherence in longitudinal studies is challenging .


Peer support and mp3-delivered peer asthma messages may not be of sufficient dose to improve outcomes .


Recent studies have demonstrated higher-quality chest compressions ( CCs ) following a 60 s ultra-brief video ( UBV ) on compression-only CPR ( CO-CPR ) .


However , the effectiveness of UBVs as a CPR-teaching tool for lay bystanders in public venues remains unknown .