Paired-sample t tests were performed on percentage change scores calculated from pre-intervention outcome measures to assess change in corticomotor excitability and changes in the slope of MEP values as percentage of AMT increased .


Quadriceps activation significantly decreased during the effusion session .


AMT and MEP change scores were not different between effusion and control conditions .


No substantial differences were found in slope between any percentages of AMT .


An experimental knee effusion did not induce changes in corticomotor excitability .


Further research is needed to understand how corticomotor pathways are affected following joint injury .


Corticomotor excitability alterations may not be the cause of acute changes in neuromuscular activation following joint effusion .


Future research should determine whether clinically altering corticomotor excitability will improve physical function .


II .


We performed this study to investigate the effect of blood pressure control in ultra-early basal ganglia intracerebral hemorrhage .


120 patients with ultra-early basal ganglia intracerebral hemorrhage were randomly divided into experimental group ( strengthened antihypertensive ) and control ( normal antihypertensive ) .


Each group consists of 60 patients , whose contractive pressure were controlled by intravenous antihypertensive drugs among 130-140 mmHg and 160-180 mmHg respectively for 24 h , after 1 h of beginning treatment .


They were all evaluated by NIH Stroke Scale ( NIHSS ) before and after the treatment .


Cranial CT , hematoma volume , hematoma enlargement , edema volume , serum matrix metalloproteinase-9 level were performed and compared between groups .


After 24 h , hematoma volume and hematoma enlargement in the experimental group was significantly lower than control ( p < 0.05 ) .


After 14 days , NIHSS score in the experimental group was significantly lower than control ( p < 0.05 ) .


Cerebral edema amount and serum MMP-9 level in the experimental group were significantly lower than control after 5 days and 14 days .


Ultra-early basal ganglia intracerebral hemorrhage can remarkably reduce hematoma enlargement , cerebral edema , serum MMP-9 level , and improve the neurological function .


It has frequently been speculated that pruritus and skin lesions develop after topical exposure to aeroallergens in sensitized patients with atopic dermatitis ( AD ) .


We sought to study cutaneous reactions to grass pollen in adult patients with AD with accompanying clear IgE sensitization to grass allergen in an environmental challenge chamber using a monocenter , double-blind , placebo-controlled study design .


Subjects were challenged on 2 consecutive days with either 4000 pollen grains/m ( 3 ) of Dactylis glomerata pollen or clean air .


The severity of AD was assessed at each study visit up to 5 days after challenge by ( objective ) scoring of AD ( SCORAD ) .


Additionally , air-exposed and non-air-exposed skin areas were each scored using local SCORAD scoring and investigator global assessments .


Levels of a series of serum cytokines and chemokines were determined by using a Luminex-based immunoassay .


The primary end point of the study was the change in objective SCORAD scores between prechallenge and postchallenge values .


Exposure to grass pollen induced a significant worsening of AD .


A pronounced eczema flare-up of air-exposed rather than covered skin areas occurred .


In grass pollen-exposed subjects a significantly higher increase in CCL17 , CCL22 , and IL-4 serum levels was observed .


This study demonstrates that controlled exposure to airborne allergens of patients with a so-called extrinsic IgE-mediated form of AD induced a worsening of cutaneous symptoms .


Certain plant polysaccharides may provide psychological health benefits .


The aim of this study was to evaluate whether they can acutely improve mood and cognitive function .


In a randomized , double-blind , placebo-controlled , between subjects design trial , 73 middle-aged adults consumed 4 g of a proprietary mixture of non-starch polysaccharides ( NSPs ) ( Ambrotose complex ) , a rice flour placebo , or a sucrose control .


Participants completed testing at baseline and 30 minutes post-consumption .


Acute effects of consumption on mood , cognition , and blood glucose were evaluated during mental tests designed to induce mental fatigue .


Significant improvement in recognition and working memory performance was observed in the group that consumed NSP compared with placebo or sucrose .


Improvements in memory performance following NSP intake were independent of changes in blood glucose .


This is the first report of acute behavioural improvement following plant polysaccharide intake in healthy middle-aged adults under conditions of mental fatigue .


The findings suggest that certain NSP may enhance memory performance through mechanisms other than elevated blood glucose .


Approximately 0.5-2 % of upper respiratory tract infections in adults and 6-13 % of viral upper respiratory tract infections in children are complicated by acute sinusitis .


This study was aimed to evaluate the coadministration effect of fluticasone nasal spray ( FNS ) with amoxicillin for AS in children .


One hundred children 2 to 14 years of age with acute sinusitis referred to Shahid Mohammadi Pediatric Hospital in Bandar Abbas were randomly allocated into two equal intervention and control groups to receive amoxicillin with fluticasone nasal spray one puff twice daily for 14 days and amoxicillin 80 to 100 mg/kg / day for 14 days respectively .


Twenty one ( 42 % ) of children in intervention group were cured completely and 2 ( 4 % ) children in control group had complete recovery ( p < 0.001 ) .


Symptom severity score was 22.98 2.95 before treatment that reduced to 13.26 3.20 after treatment ( p < 0.001 ) .


Use of fluticasone can reduce the severity of symptoms of sinusitis in children .


Test the efficacy of SmartLoss , a smartphone-based weight loss intervention , in a pilot study .


A 12-week randomized controlled trial .


Adults ( 25BMI35 kg/m2 ) were randomized to SmartLoss ( n = 20 ) or an attention-matched Health Education control group ( n = 20 ) .


SmartLoss participants were prescribed a 1,200 to 1,400 kcal/d diet and were provided with a smartphone , body weight scale , and accelerometer that wirelessly transmitted body weight and step data to a website .


In the SmartLoss Group , mathematical models were used to quantify dietary adherence based on body weight and counselors remotely delivered treatment recommendations based on these objective data .


The Health Education group received health tips via smartphone .


A mixed model determined if change in weight and other endpoints differed between the groups ( baseline was a covariate ) .


The sample was 82.5 % female .


MeanSD baseline age , weight ( kg ) , and BMI were 44.411.8 years , 80.311.5 kg , and 29.82.9 kg/m2 , respectively .


One participant was lost to follow-up in each group before week 4 .


Weight loss was significantly ( P < 0.001 ) larger in the SmartLoss ( least squares meanSEM : -9.40.5 % ) compared with the Health Education group ( -0.60.5 % ) .


SmartLoss efficaciously promote clinically meaningful weight loss compared with an attention-matched control group .


Smartphone-based interventions might prove useful in intervention dissemination .


To study the therapeutic effects of different doses of botulinum toxin A ( BTX-A ) injection on tiptoe deformation in children with cerebral palsy .


A total of 256 children with tiptoe deformation due to spastic cerebral palsy were classified into group A ( muscle tension levels I-II , n = 147 ) and group B ( muscle tension levels III-IV , n = 109 ) .


Group A was randomly divided into group A1 ( injected with high-dose BTX-A , n = 73 ) and group A2 ( injected with low-dose BTX-A , n = 74 ) .


Group B was randomly divided into group B1 ( injected with high-dose BTX-A , n = 55 ) and group B2 ( injected with low-dose BTX-A , n = 54 ) .


The dose of BTX-A was 6 U/kg for groups A1 and B1 and was 3 U/kg for groups A2 and B2 .


Before the injection and at 1,2,6 , and 12 months after injection , the muscle tension of limbs was evaluated with the modified Ashworth Scale , and the recovery of motor function of lower limbs was assessed with the Gross Motor Function Measure ( GMFM ) .


Before and after treatment , there were no significant differences in Ashworth and GMFM scores between groups A1 and A2 ( P > 0.05 ) .


After treatment , group B1 had a significantly reduced Ashworth score and a significantly increased GMFM score , and group B1 had a significantly lower Ashworth score and a significantly higher GMFM score compared with group B2 ( P < 0.05 ) .


For groups A and B , Ashworth score gradually declined post-treatment , reached the lowest point at 3 months after treatment , and returned to the level before treatment at 12 months after treatment ; GMFM score gradually increased post-treatment and reached the peak level at 12 months after treatment ( P < 0.05 ) .


The level of muscle tension should be considered when BTX-A injection is used for treating tiptoe deformation in children with cerebral palsy .


It makes no difference to use high - or low-dose BTX-A when the muscle tension level is within I-II , but high-dose BTX-A has a better performance in reducing muscle tension and improving motor function when the muscle tension level is within III-IV .


Human immunodeficiency virus ( HIV ) - infected individuals are at increased risk of herpes zoster ( HZ ) , even in the antiretroviral therapy ( ART ) era .


Because concerns exist about the use of live-attenuated vaccines in immunocompromised individuals , a subunit vaccine may be an appropriate alternative .


This phase 1/2 , randomized , placebo-controlled study evaluated the immunogenicity and safety of an investigational HZ subunit vaccine ( HZ/su ) .


Three cohorts of HIV-infected adults aged 18 years were enrolled : 94 ART recipients with a CD4 ( + ) T-cell count of 200 cells/mm ( 3 ) , 14 ART recipients with a CD4 ( + ) T-cell count of 50-199 cells/mm ( 3 ) , and 15 ART-naive adults with a CD4 ( + ) T-cell count of 500 cells/mm ( 3 ) .


Subjects received 3 doses of HZ/su ( 50 g varicella-zoster virus glycoprotein E [ gE ] combined with AS01B adjuvant ) or 3 doses of saline at months 0 , 2 , and 6 .


One month after dose 3 , serum anti-gE antibody concentrations and frequencies of gE-specific CD4 ( + ) T cells were higher following HZ/su vaccination than after receipt of saline ( P < .0001 ) .


Median cell-mediated immune responses peaked after dose 2 .


Humoral and cell-mediated immune responses persisted until the end of the study ( month 18 ) .


No vaccination-related serious adverse events were reported .


No sustained impact on HIV load or CD4 ( + ) T-cell count was noted following vaccinations .


HZ/su was immunogenic and had a clinically acceptable safety profile in HIV-infected adults .


NCT01165203 .


To describe the incidence and outcomes of endophthalmitis after intravitreal injections of anti-vascular endothelial growth factor agents in the Comparison of Age-Related Macular Degeneration Treatments Trials ( CATT ) and to assess the effect of prophylactic topical antimicrobials on incidence .


Cohort study within a randomized clinical trial .


Patients enrolled in CATT .


Patients with neovascular age-related macular degeneration received intravitreal injections of ranibizumab or bevacizumab under 1 of 3 dosing regimens .


The study protocol specified preinjection preparation to include use of a sterile lid speculum and povidone iodine ( 5 % ) .


Use of preinjection and postinjection antibiotics was at the discretion of the treating ophthalmologist .


Patients were followed up monthly for 2 years .


Development of endophthalmitis and visual acuity .


Endophthalmitis developed after 11 of 18 509 injections ( 1 per 1700 [ 0.06 % ] ; 95 % confidence interval , 0.03 % -0.11 % ) , and in 11 of 1185 patients ( 0.93 % ; 95 % confidence interval , 0.52-1 .66 ) .


Incidence of endophthalmitis was 0.15 % among injections with no antibiotic use , 0.08 % among injections with preinjection antibiotics only , 0.06 % among injections with postinjection antibiotics only , and 0.04 % among injections with preinjection and postinjection antibiotics ( P = 0.20 ) .


All eyes were treated with intravitreal antibiotics and 4 underwent vitrectomy .


Among the 11 affected eyes , the final study visual acuity was 20/40 or better in 4 eyes ( 36 % ) , 20/50 to 20/80 in 2 eyes ( 18 % ) , 20/100 to 20/160 in 3 eyes ( 27 % ) , and worse than 20/800 in 2 eyes ( 18 % ) .


The final visual acuity was within 2 lines of the visual acuity before endophthalmitis in 5 eyes ( 45 % ) .


Rates of endophthalmitis were low and similar to those in other large-scale studies .


Use of topical antibiotics either before or after injection does not seem to reduce the risk for endophthalmitis .


Etomidate is a hypnotic drug widely used as an intravenous anesthetic induction agent .


The incidence of etomidate-induced myoclonus has been reported as much as 50-80 % after induction making it an undesirable drug for induction .


Our aim is to use a priming dose of atracurium to suppress etomidate-induced myoclonus during induction of anesthesia .


In a double-blinded clinical trial 80 patients were randomly given either atracurium ( 20 % of ED95 kg ) or saline as a priming agent .


Then , induction of anesthesia was performed using 0.4 mg/kg etomidate .


Age , weight , body mass index , bispectral index ( BIS ) monitor , and duration and grade of myoclonus were recorded .


The demographic characteristics , age , body mass index , BIS score , and weight were not significantly different between the atracurium ( ATRA ) priming group and control groups .


The binomial regression model showed that BMI was an independent predictor variable for myoclonus ( OR : 2.1 , CI 95 % : 1.7-7 .5 , p = 0.032 ) .


In this model , adjusted odds ratios ( OR ) of myoclonus ( multivariate logistic regression analysis ) in the control group was 6.6 ( 95 % CI : 1.5-9 .7 , p = 0.013 ) .


Low-dose atracurium priming could effectively suppress etomidate-induced myoclonus .


Telehealth is an emerging field of clinical practice but current UK health policy has not taken account of the perceptions of front-line healthcare professionals expected to implement it .


To investigate telehealth care for people with long-term conditions from the perspective of the front-line health professional .


A qualitative study in three sites within the UK ( Kent , Cornwall , and the London Borough of Newham ) and embedded in the Whole Systems Demonstrator evaluation , a large cluster randomised controlled trial of telehealth and telecare for patients with long-term and complex conditions .


Semi-structured qualitative interviews with 32 front-line health professionals ( 13 community matrons , 10 telehealth monitoring nurses and 9 GPs ) involved in the delivery of telehealth .


Data were analysed using a modified grounded theory approach .


Mixed views were expressed by front-line professionals , which seem to reflect their levels of engagement .


It was broadly welcomed by nursing staff as long as it supplemented rather than substituted their role in traditional patient care .


GPs held mixed views ; some gave a cautious welcome but most saw telehealth as increasing their work burden and potentially undermining their professional autonomy .


Health care professionals will need to develop a shared understanding of patient self-management through telehealth .


This may require a renegotiation of their roles and responsibilities .


Patients with end-stage kidney disease ( ESKD ) have a high rate of mortality and specifically an increased risk of sudden cardiac death ( SCD ) .


Impaired cardiac autonomic tone is associated with elevated risk of SCD .


Moreover , patients with ESKD are often vitamin D deficient , which we have shown may be linked to autonomic dysfunction in humans .


To date , it is not known whether vitamin D supplementation normalizes cardiac autonomic function in the high-risk ESKD population .


The VITamin D supplementation and cardiac Autonomic tone in Hemodialysis ( VITAH ) randomized trial will determine whether intensive vitamin D supplementation therapies improve cardiac autonomic tone to a greater extent than conventional vitamin D supplementation regimens in ESKD patients requiring chronic hemodialysis .


A total of 60 subjects with ESKD requiring thrice weekly chronic hemodialysis will be enrolled in this 2x2 crossover , blinded , randomized controlled trial .


Following a 4-week washout period from any prior vitamin D therapy , subjects are randomized 1:1 to intensive versus standard vitamin D therapy for 6 weeks , followed by a 12-week washout period , and finally the remaining treatment arm for 6 weeks .


Intensive vitamin D treatment includes alfacalcidiol ( activated vitamin D ) 0.25 mcg orally with each dialysis session combined with ergocalciferol ( nutritional vitamin D ) 50 000 IU orally once per week and placebo the remaining two dialysis days for 6 weeks .


The standard vitamin D treatment includes alfacalcidiol 0.25 mcg orally combined with placebo each dialysis session per week for 6 weeks .


Cardiac autonomic tone is measured via 24 h Holter monitor assessments on the first dialysis day of the week every 6 weeks throughout the study period .


The primary outcome is change in the low frequency : high frequency heart rate variability ( HRV ) ratio during the first 12 h of the Holter recording at 6 weeks versus baseline .


Secondary outcomes include additional measures of HRV .


The safety of intensive versus conventional vitamin D supplementation is also assessed .


VITAH will determine whether an intensive vitamin D supplementation regimen will improve cardiac autonomic tone compared to conventional vitamin D supplementation and will assess the safety of these two supplementation regimens in ESKD patients receiving chronic hemodialysis .


ClinicalTrials.gov , NCT01774812 .


Interferon ( IFN ) negatively impacts patients ' well-being and patient-reported outcomes ( PROs ) .


Our aim was to assess PROs during treatment with an IFN-free regimen [ sofosbuvir ( SOF ) + ribavirin ( RBV ) ] .


Four PRO questionnaires [ Short Form-36 ( SF-36 ) , Chronic Liver Disease Questionnaire-HCV ( CLDQ-HCV ) , Functional Assessment of Chronic Illness Therapy-Fatigue ( FACIT-F ) , Work Productivity and Activity Index : Specific Health Problem ( WPAI : SHP ) ] were administered at baseline , end-of-treatment and post-treatment to 334 HCV genotype 2 and 3 patients ( nave or treatment-experienced ) enrolled in the VALENCE study .


Of these , 250 genotype 3 patients were treated for 24 weeks while 73 genotype 2 and 11 genotype 3 patients received 12 weeks of treatment .


Baseline PRO scores were similar between the two arms of the study .


Throughout and after treatment , patients receiving 12 or 24 weeks had similar FACIT-F , CLDQ-HCV , SF-36 and WPAI : SHP scores ( all p > 0.05 ) .


Compared to their own baseline scores , patients receiving SOF+RBV experienced modest declines in some aspects of SF-36 , CLDQ-HCV , fatigue and WPAI : SHP scores ( p = 0.04 to < 0.0001 ) .


By follow-up week 12 , all PRO scores returned to the pre-treatment levels ( p > 0.05 ) .


In patients achieving SVR-12 ( regardless of the regimen ) , significant improvements were noted in general health ( p = 0.0004 ) , CLDQ-HCV ( p < 0.0001 ) , fatigue ( p = 0.005 ) , emotional well-being ( p < 0.0001 ) and physical component summary score of SF-36 ( p = 0.0022 ) .


In multivariate analysis , baseline depression , fatigue , insomnia , cirrhosis , and treatment-related adverse events were the most consistent predictors of PRO impairment ( all p < 0.05 ) .


PROs are minimally impacted by SOF+RBV regimens .


An additional 12 weeks of treatment does not substantially add to the PRO burden .


Despite beneficial effects on communication and process measures , client-centred practice has been shown to result in poor functional outcomes .


To examine a potential explanation for poor functional outcomes , this paper aims to assess whether in client-centred therapy more time is spent on diagnostic consultation and less time on actual treatment compared to usual care .


A multicentre cluster randomised controlled trial was performed .


Thirteen hospitals and rehabilitation centres , 29 therapists and 269 outpatients with multiple sclerosis participated .


Measurements included an inventory of diagnostic and treatment goals , the number of sessions , therapy duration and therapy intensity .


In client-centred therapy , more sessions were used for diagnostic consultation ( 10.9 % points difference , p = 0.030 ) ; the time needed to formulate the first treatment goal was longer ( 11.4 days difference , p = 0.041 ) ; there was a tendency towards more goals directed to diagnostic issues ( 0.69 goals difference , p = 0.056 ) , spending more hours on indirect issues ( 1.16 h difference , p = 0.051 ) and towards a longer total therapy period ( 1.56 months difference , p = 0.058 ) than in usual care .


Client-centred therapy resulted in more intensive diagnostic evaluation and less intensive treatment .


This suggests that client-centred therapy should be adjusted towards a more proportional distribution of time devoted to diagnostic evaluation versus actual treatment .


Systemic steroids are the standard treatment for bronchiolitis obliterans syndrome ( BOS ) after allogeneic hematopoietic stem cell transplantation ( HSCT ) despite their poor efficacy and disabling side effects .


To evaluate the effectiveness and tolerance of budesonide/formoterol as an alternative treatment for BOS after HSCT .


In this randomized , double-blind , placebo-controlled study , we randomly assigned 32 HSCT recipients with mild/severe BOS to receive budesonide/formoterol or placebo for 6 months .


The primary outcome was the change in the FEV1 after 1 month of treatment ( M1 ) compared with the baseline value .


Patients were unblinded at M1 if there was no improvement in the FEV1 .


Those who had initially received placebo were switched to budesonide/formoterol .


Intention-to-treat analysis was performed to assess the primary outcome .


Additional analyses took scheduled treatment contamination into account .


At M1 , the median FEV1 increased by 260 ml in the budesonide/formoterol arm compared with 5 ml in the placebo arm ( P = 0.012 ) .


The median increases in the FEV1 at M1 relative to the baseline value for the treated and placebo groups were 13 and 0 % , respectively ( P = 0.019 ) .


Twenty-five patients received budesonide/formoterol during the study .


The median difference in the FEV1 between the baseline and after 1 month of treatment for these patients was +240 ml ( P = 0.0001 ) .


The effect of budesonide/formoterol on the FEV1 was maintained in the 13 patients who completed 6 months of treatment .


Budesonide/formoterol administration led to a significant improvement in the FEV1 in patients with mild/severe BOS after allogeneic HSCT .


Clinical trial registered with www.clinicaltrials.gov ( NCT00624754 ) .


To compare the difference of anterior knee pain after total knee arthroplasty ( TKA ) between the ways using periosteal dissector and electric scalpel to release medial collateral ligament and pes anserinus .


From September 2009 to September 2012 , 220 patients with unilateral osteoarthritis were treated with primary TKA in hospital 301 .


All the patients were randomly divided into periosteal dissector group ( 110 cases ) or electric scalpel group ( 110 cases ) .


In the periosteal dissector group , there were 47 males and 63 females , with an average age of ( 58.8 + / - 17.2 ) years old ; the degree of genuavarus was ( 14.0 + / - 3.5 ) degrees ; the weight was ( 65.6 + / - 12.8 ) kg ; the body mass index ( BMI ) was ( 26.6 + / - 3.6 ) kg/m2 .


In the electric scalpel group , there were 49 males and 61 females , with an average age of ( 59.6 + / - 16.7 ) years old ; the degree of genuavarus was ( 15.0 + / - 4.7 ) degrees ; the weight was ( 66.4 + / - 13.4 ) kg ; the BMI was ( 27.4 + / - 4.1 ) kg/m2 .


The mean follow-up period was 24.6 months .


The AKS , VAS and HSS were used to evaluate clinical results .


All incisions healed at the first stage ; no deep vein thrombosis of lower limbs or pulmonary embolism occurred .


Knee infection occurred in 3 cases ( 1 in the periosteal dissector group and 2 in the electric scalpel group ) , and the 3 patients received stage 2 total knee revision using antibiotic bone cement and TC3 prosthesis .


No recurrence of infection occurred during follow-up .


Among the 20 patients who had anterior knee pain , 16 patients were in the periosteal dissector group and 4 patients were in the electric scalpel group .


The occurrence rate of anterior knee pain in the electric scalpel group was lower than that in the periosteal dissector group .


The AKS knee score and HSS score after total knee arthroplasty in the electric scalpel group were all higher than those in the periosteal dissector group , and the VAS in electric scalpel group was lower than that of periosteal dossector group .


Compared with using electric scalpel , using periosteal dissector used to release medial collateral ligament and pes anserinus may cause more anterior knee pain after total knee arthroplasty .


To examine the effect of co-bedding between preterm twins on stress response after heel lance .


Using a multisite randomized controlled trial design , stable preterm twins ( 67 sets , N = 134 infants ) between 28 and 36 completed weeks ' gestational age , stratified by gestational age ( and > 32 weeks ) and site , were randomly assigned to a co-bedding group , cared for continuously in the same incubator or crib or a standard care group , cared for in a separate incubator or crib , and underwent a medically indicated heel lance after at least 24 hours and no greater than 10 days of group allocation .


The reported outcome was cortisol from saliva samples from 89 twins ( n = 49 co-bedding , n = 40 standard care ) collected immediately before the heel lance ( baseline levels ) and 113 twins ( n = 58 co-bedding , n = 55 standard care ) collected 20 minutes after heel lance ( stress levels ) as an index of stress response .


No group differences were noted in baseline salivary cortisol levels : 0.36 g/dL ( SD 0.25 ) in the co-bedding group and 0.43 g/dL ( SD 0.50 ) in the standard care group .


Twenty minutes after lance , levels were significantly lower in the co-bedding group , 0.28 g/dL ( SD 0.25 ) versus 0.50 g/dL ( SD 0.73 ) in the standard group ( P = 0.04 ) .


Similarly , the mean of paired changes in salivary cortisol from baseline was lower in the co-bedding group ( -0.06 g/dL ) compared with the standard care group ( 0.14 g/dL , P < 0.05 ) .


Co-bedding attenuates the stress response of preterm twins undergoing heel lance .


clinicaltrials.gov Identifier : NCT009176 .


A common obesity-risk variant rs9939609 in the fat mass - and obesity-associated ( FTO ) gene was recently shown to affect appetite , and the gene is sensitive to the regulation of amino acids .


We examined the interaction between FTO genotype and protein intake on the long-term changes in appetite in a randomized controlled trial .


We genotyped FTO rs9939609 in 737 overweight adults in the 2-y Preventing Overweight Using Novel Dietary Strategies trial and assessed 4 appetite-related traits including cravings , fullness , hunger , and prospective consumption .


We showed that dietary protein significantly modified genetic effects on changes in food cravings and appetite scores at 6 mo after adjustment for age , sex , ethnicity , baseline body mass index , weight change , and baseline value for respective outcomes ( P-interaction = 0.027 and 0.048 , respectively ) .


The A allele was associated with a greater decrease in food cravings and appetite scores in participants with high-protein-diet intake ( P = 0.027 and 0.047 , respectively ) but not in subjects in the low-protein-diet group ( P = 0.384 and 0.078 , respectively ) .


The weight regain from 6 to 24 mo attenuated gene-protein interactions .


Protein intakes did not modify FTO genotype effects on other appetite measures .


Our data suggest that individuals with the FTO rs9939609 A allele might obtain more benefits in a reduction of food cravings and appetite by choosing a hypocaloric and higher-protein weight-loss diet .


This trial was registered at clinicaltrials.gov as NCT00072995 .


Trachomatous trichiasis ( TT ) needs to be managed to reduce the risk of vision loss .


The long-term impact of epilation ( a common traditional practice of repeated plucking of lashes touching the eye ) in preventing visual impairment and corneal opacity from TT is unknown .


We conducted a randomized controlled trial of epilation versus surgery for the management of minor TT ( fewer than six lashes touching the eye ) in Ethiopia .


Here we report the four-year outcome and the effect on vision and corneal opacity .


1300 individuals with minor TT were recruited and randomly assigned to quality trichiasis surgery or repeated epilation using high quality epilation forceps by a trained person with good near vision .


Participants were examined six-monthly for two-years , and then at four-years after randomisation .


At two-years all epilation arm participants were offered free surgery .


At four-years 1151 ( 88.5 % ) were re-examined : 572 ( 88 % ) and 579 ( 89 % ) from epilation and surgery arms , respectively .


At that time , 21.1 % of the surgery arm participants had recurrent TT ; 189/572 ( 33 % ) of the epilation arm had received surgery , while 383 ( 67 % ) declined surgery and had continued epilating ( `` epilation-only '' ) .


Among the epilation-only group , 207 ( 54.1 % ) fully controlled their TT , 166 ( 43.3 % ) had minor TT and 10 ( 2.6 % ) had major TT ( > 5 lashes ) .


There were no differences between participants in the epilation-only , epilation-to-surgery and surgery arm participants in changes in visual acuity and corneal opacity between baseline and four-years .


Most minor TT participants randomised to the epilation arm continued epilating and controlled their TT .


Change in vision and corneal opacity was comparable between surgery and epilation-only participants .


This suggests that good quality epilation with regular follow-up is a reasonable second-line alternative to surgery for minor TT for individuals who either decline surgery or do not have immediate access to surgical treatment .


To evaluate dexmedetomidine as adjunctive therapy to lorazepam for severe alcohol withdrawal .


Prospective , randomized , double-blind , placebo-controlled trial .


Single center ; medical ICU .


Twenty-four adult patients with a Clinical Institute Withdrawal Assessment score greater than or equal to 15 despite greater than or equal to 16 mg of lorazepam over a 4-hour period .


Patients received a symptom-triggered Clinical Institute Withdrawal Assessment protocol with lorazepam and were randomized to dexmedetomidine 1.2 g/kg/hr ( high dose ) , 0.4 g/kg/hr ( low dose ) , or placebo as adjunctive therapy for up to 5 days or resolution of withdrawal symptoms .


High-dose and low-dose groups were combined as a single dexmedetomidine group for primary analysis with secondary analysis exploring a dose-response relationship .


The difference in 24-hour lorazepam requirements after versus before study drug was greater in the dexmedetomidine group compared with the placebo group ( -56 mg vs -8 mg , p = 0.037 ) .


Median differences were similar for high dose and low dose .


The 7-day cumulative lorazepam requirements were not statistically different between dexmedetomidine and placebo ( 159 mg vs 181 mg ) .


Clinical Institute Withdrawal Assessment or Riker sedation-agitation scale scores representing severe agitation ( 13 % vs 25 % ) or moderate agitation ( 27 % vs 22 % ) within 24 hours of initiating study drug were similar for dexmedetomidine and placebo groups , respectively .


Bradycardia occurred more frequently in the dexmedetomidine group versus placebo group ( 25 % vs 0 % , p = not significant ) , with the majority of bradycardia occurring in the high-dose group ( 37.5 % ) .


Study drug rate adjustments occurred more often in the dexmedetomidine group compared with the placebo group ( 50 % vs 0 % , p = 0.02 ) .


Neither endotracheal intubation nor seizure occurred in any group while on study drug .


Adjunctive dexmedetomidine for severe alcohol withdrawal maintains symptom control and reduces lorazepam exposure in the short term , but not long term , when using a symptom-triggered protocol .


Monitoring for bradycardia is needed with dexmedetomidine but the occurrence may be lessened with low dose .


Further study is needed to evaluate the clinical impact of dexmedetomidine .


The aims of this study were to assess the effects of 0.2 mL of 4 % atomized lidocaine on swallowing and tolerability during Fiberoptic Endoscopic Evaluation of Swallowing ( FEES ) .


A single blinded study was conducted with 17 dysphagic patients , who received 4 standardized boluses in 2 sequential FEES exams under 2 conditions : non-anesthetized ( decongestant only ) and anesthetized ( lidocaine 4 % + decongestant ) .


After each procedure , patients rated their pain on the Wong Baker FACES Pain Rating Scale .


Clinicians scored each swallow with the Penetration Aspiration Scale ( PAS ) and an author-developed Residue Rating Scale .


Because the assessments were ordinal , a series of Wilcoxon signed-rank tests were conducted to detect differences between the 2 conditions .


No significant differences were detected between groups on PAS or residue in the 4 boluses .


Pain scores , however , were significantly lower in the anesthetized condition than the decongested-only condition ( P = .035 ) .


The findings of this study indicated that 0.2 mL of 4 % lidocaine enhanced exam tolerability and did not impair the swallow in dysphagic patients .


The prevention and treatment of childhood obesity is a key public health challenge .


However , certain groups within populations have markedly different risk profiles for obesity and related health behaviours .


Well-designed subgroup analysis can identify potential differential effects of obesity interventions , which may be important for reducing health inequalities .


The study aim was to evaluate the consistency of the effects of active video games across important subgroups in a randomised controlled trial ( RCT ) .


A two-arm , parallel RCT was conducted in overweight or obese children ( n = 322 ; aged 10-14 years ) to determine the effect of active video games on body composition .


Statistically significant overall treatment effects favouring the intervention group were found for body mass index , body mass index z-score and percentage body fat at 24 weeks .


For these outcomes , pre-specified subgroup analyses were conducted among important baseline demographic ( ethnicity , sex ) and prognostic ( cardiovascular fitness ) groups .


No statistically significant interaction effects were found between the treatment and subgroup terms in the main regression model ( p = 0.36 to 0.93 ) , indicating a consistent treatment effect across these groups .


Preliminary evidence suggests an active video games intervention had a consistent positive effect on body composition among important subgroups .


This may support the use of these games as a pragmatic public health intervention to displace sedentary behaviour with physical activity in young people .


XARTEMIS XR ( formerly MNK-795 ) is a combination oxycodone ( OC ) and acetaminophen ( APAP ) analgesic with both immediate-release and extended-release ( ER ) components ( ER OC/APAP ) .


The tablets are designed with gastric-retentive ER oral delivery technology that releases the ER component at a controlled rate in the upper gastrointestinal tract .


Because consumption of food has demonstrated an impact on the pharmacokinetics ( PK ) of some marketed products using gastric-retentive ER oral delivery technology , a characterization of the effects of fed ( high - and low-fat diets ) versus fasted conditions on the PK of ER OC/APAP was performed .


This Phase I study used an open-label randomized single-dose three-period six-sequence crossover single-center design .


Healthy adult participants ( n = 48 ) were randomized to receive two tablets of ER OC/APAP under three conditions : following a high-fat meal ; following a low-fat meal ; and fasted .


Plasma concentration versus time data from predose throughout designated times up to 48 hours postdose was used to estimate the PK parameters of oxycodone and APAP .


Thirty-one participants completed all three treatment periods .


Both oxycodone and APAP were rapidly absorbed under fasted conditions .


Total oxycodone and APAP exposures ( area under the plasma drug concentration-time curve [ AUC ] ) from ER OC/APAP were not significantly affected by food , and minimal changes to maximum observed plasma concentration for oxycodone and APAP were also noted .


However , food marginally delayed the time to maximum observed plasma concentration of oxycodone and APAP .


There was no indication that tolerability was affected by food .


The findings from this study suggest that ER OC/APAP can be administered with or without food .


Strategies to improve infant and young child nutrition in low - and middle - income countries need to be implemented at scale .


We contextualised and packaged successful strategies into a feasible intervention for implementation in rural Tanzania .


Opportunities that can optimise delivery of the intervention and encourage behaviour change include mothers willingness to modifying practices ; support of family members ; seasonal availability and accessibility of foods ; established set-up of village peers and functioning health system .


The primary objective of the study is to evaluate the effectiveness of a nutrition education package in improving feeding practices , dietary adequacy and growth as compared to routine health education .


A parallel cluster randomised controlled trial will be conducted in rural central Tanzania in 9 intervention and 9 control villages .


The control group will receive routine health education offered monthly by health staff at health facilities .


The intervention group will receive a nutrition education package in addition to the routine health education .


The education package is comprised of four components : 1 ) education and counselling of mothers , 2 ) training community-based nutrition counsellors and monthly home visits , 3 ) sensitisation meetings with health staff and family members , and 4 ) supervision of community-based nutrition counsellors .


The duration of the intervention is 9months and infants will be recruited at 6months of age .


Primary outcome ( linear growth as length-for-age Z-scores ) and secondary outcomes ( changes in weight-for-length Z-scores ; mean intake of energy , fat , iron and zinc from complementary foods ; proportion of children consuming 4 or more food groups and recommended number of semi-solid/soft meals and snacks per day ; maternal level of knowledge and performance of recommended practices ) will be assessed at baseline and ages 9 , 12 and 15months .


Process evaluation will document reach , dose and fidelity of the intervention and context at 8 and 15months .


Results of the trial will provide evidence of the effectiveness of the nutrition education package in community settings of rural Tanzania .


They will provide recommendations for strengthening the nutrition component of health education in child health services .


ClinicalTrials.gov Identifier : NCT02249754 , September 25 , 2014 .


This pilot study aimed to determine whether raw milk reduces lactose malabsorption and/or lactose intolerance symptoms relative to pasteurized milk .


We performed a crossover trial involving 16 adults with self-reported lactose intolerance and lactose malabsorption confirmed by hydrogen ( H2 ) breath testing .


Participants underwent 3 , 8-day milk phases ( raw vs 2 controls : pasteurized , soy ) in randomized order separated by 1-week washout periods .


On days 1 and 8 of each phase , milk consumption was 473 mL ( 16 oz ) ; on days 2 to 7 , milk dosage increased daily by 118 mL ( 4 oz ) , beginning with 118 mL ( 4 oz ) on day 2 and reaching 710 mL ( 24 oz ) on day 7 .


Outcomes were area under the breath H2 curve ( AUC H2 ) and self-reported symptom severity ( visual analog scales : flatulence/gas , audible bowel sounds , abdominal cramping , diarrhea ) .


AUC H2 ( mean standard error of the mean ) was higher for raw vs pasteurized on day 1 ( 113 21 vs 71 12 ppmmin10 ( -2 ) , respectively , P = .01 ) but not day 8 ( 72 14 vs 74 15 ppmmin10 ( -2 ) , respectively , P = .9 ) .


Symptom severities were not different for raw vs pasteurized on day 7 with the highest dosage ( P > .7 ) .


AUC H2 and symptom severities were higher for both dairy milks compared with soy milk .


Raw milk failed to reduce lactose malabsorption or lactose intolerance symptoms compared with pasteurized milk among adults positive for lactose malabsorption .


These results do not support widespread anecdotal claims that raw milk reduces the symptoms of lactose intolerance .


Nocturnal periodic breathing occurs more frequently in men than in women with various clinical and pathophysiologic conditions .


The mechanisms accounting for this sex-related difference are not completely understood .


Acetazolamide effectively counteracts nocturnal periodic breathing , but it has been investigated almost exclusively in men .


Our aim was to explore possible determinants of nocturnal periodic breathing in a high-altitude setting both in men and in women .


We hypothesized that increased hypoxic chemosensitivity in men could be associated with the development of nocturnal periodic breathing at altitude more frequently than in women , and that acetazolamide , by leftward shifting the CO2 ventilatory response , could improve nocturnal periodic breathing at altitude in a sex-independent manner .


Forty-four healthy lowlanders ( 21 women ) , randomized to acetazolamide or placebo , underwent cardiorespiratory sleep studies at sea level off treatment and under treatment on the first night after arrival at a 4,559-m altitude .


Hypoxic and hypercapnic chemosensitivities were assessed at sea level .


Men , more frequently than women , exhibited increased hypoxic chemosensitivity and displayed nocturnal periodic breathing at altitude .


Acetazolamide leftward shifted the CO2 set point and , at altitude , improved oxygenation and reduced periodic breathing in both sexes , but to a larger extent in men .


Hypoxic chemosensitivity directly correlated with the number of apneas/hypopneas at altitude in the placebo group but not in the acetazolamide group .


The greater severity of periodic breathing during sleep displayed by men at altitude could be attributed to their increased hypoxic chemosensitivity .


Acetazolamide counteracted the occurrence of periodic breathing at altitude in both sexes , modifying the apneic threshold and improving oxygenation .


EU Clinical Trials Register , EudraCT ; No. : 2010-019986-27 ; URL : https://www.clinicaltrialsregister.eu .


Use of an arterial catheter to obtain hourly blood samples for intensive insulin therapy monitoring avoids causing patients the discomfort of repeated fingersticks .


Returning the clearing volume may decrease procedure-related blood loss by 50 % and minimize the risk of anemia .


To compare the feasibility of 2 arterial catheter clearing-volume return setups for hourly blood extractions and to evaluate the related complications and the accuracy of arterial samples in determining glycemia .


In an open clinical trial , 90 critical patients undergoing intensive insulin therapy who had a radial arterial catheter were randomized to an intervention group-nonwaste needleless setup or nonwaste syringe setup and compared with the standard setup ( control group ) .


Mechanical and infectious complications related to the arterial catheter were evaluated .


Blood glucose measurements at point-of-care glucometer ( arterial catheter or fingerstick sample ) were compared with laboratory results ( venous blood ) .


No patient had catheter-related infection in the intervention group ( an estimated 12776 manipulations ) ; the control group had 2 infection episodes in 5230 catheter-days ( an estimated 13 075 manipulations ) .


The incidence of bacterial colonization was not significantly higher in the needleless group than in the syringe group ( 22.2 % vs 12.2 % ; relative risk , 0.55 ; 95 % CI , 0.16-1 .71 ) , with 1778 ( SD , 114 ) and 1918 ( SD , 82 ) catheter manipulations , respectively .


Arterial catheter complications were negligible in all patients .


Glycemia was detected from arterial catheter samples as effectively as with laboratory results ( venous samples ) except when hematocrit was less than 25 % .


Use of blood obtained via an arterial catheter is safe and effective for glucose monitoring in patients undergoing intensive insulin therapy , with no increase in complications of catheterization .


Caffeine , probably the most widely consumed psychoactive substance , is claimed to have conflicting effects on some tear film dynamics .


This study sought to investigate the effect of orally ingested caffeine on tear secretion .


In an examiner-masked , placebo-controlled , crossover experimental model , the effect of caffeine intake on tear secretion was studied in 41 healthy volunteers aged 20 to 26 years ( mean , 23.0 2.1 years ) .


Participants were randomly assigned into two groups , A and B , to receive two different treatments in two sessions .


Subjects in group A were exposed to 5.0 mg/kg body weight of caffeine dissolved in 200 mL of water on their first visit , whereas those in group B were exposed to 200 mL of water .


On the second visit , however , the order of treatment was reversed .


Schirmer 1 scores were measured repeatedly at 45 , 90 , 135 , and 180 minutes after treatment .


The baseline Schirmer 1 scores were compared with posttreatment scores .


Schirmer 1 scores increased after caffeine intake .


The increase was statistically significant at 45 and 90 minutes ( p < 0.05 ) after caffeine intake .


Age , body mass , and blood pressure had no correlation with Schirmer 1 scores ( Spearman correlation test , p > 0.05 ) .


There was no influence of gender in caffeine 's effect on tear secretion ( F = 0.994 , p = 0.399 ) .


From our study , orally ingested caffeine appears to stimulate tear secretion in healthy non-dry eye subjects .


Biliary decompression with antibiotic therapy is the mainstay treatment for acute cholangitis with bacteremia .


A few studies have been conducted to investigate the optimal duration and route of antibiotic therapy in biliary tract infection with bacteremia .


Patients with acute cholangitis with bacteremia who achieved successful biliary drainage were randomly assigned to an early oral antibiotic switch group ( group A , n = 29 ) and a conventional intravenous antibiotics group ( group B , n = 30 ) .


Patients were discharged when they were afebrile over 2days after oral antibiotic switch and showed consecutive improvement in the laboratory index .


They were followed up and assessed at 30days after diagnosis to evaluate the eradication of bacteria , recurrence of acute cholangitis , and 30-day mortality rate .


There were no statistically significant differences between the two groups in baseline characteristics , clinical and laboratory index , severity of acute cholangitis , bacteria isolated from blood cultures , and clinical outcomes .


The rate of eradication of bacteria was 93.1 % in group A and 93.3 % in group B , respectively ( p = 0.97 ) .


Using non-inferiority tests , the rate of eradication of bacteria in group A was not inferior to that in group B ( 95 % CI -0.13 to 0.14 , p = 0.97 ) .


There was no statistically significant difference in the recurrence of acute cholangitis and a 30-day mortality rate between the two groups .


Early switch to oral antibiotic therapy following adequate biliary drainage for treatment of acute cholangitis with bacteremia was not inferior to conventional 10-day intravenous antibiotic therapy .


The benefit of the combination of serum galactomannan ( GM ) assay and polymerase chain reaction ( PCR ) - based detection of serum Aspergillus DNA for the early diagnosis and therapy of invasive aspergillosis ( IA ) in high-risk hematological patients remains unclear .


We performed an open-label , controlled , parallel-group randomized trial in 13 Spanish centers .


Adult patients with acute myeloid leukemia and myelodysplastic syndrome on induction therapy or allogeneic hematopoietic stem cell transplant recipients were randomized ( 1:1 ratio ) to 1 of 2 arms : `` GM-PCR group '' ( the results of serial serum GM and PCR assays were provided to treating physicians ) and `` GM group '' ( only the results of serum GM were informed ) .


Positivity in either assay prompted thoracic computed tomography scan and initiation of antifungal therapy .


No antimold prophylaxis was permitted .


Overall , 219 patients underwent randomization ( 105 in the GM-PCR group and 114 in the GM group ) .


The cumulative incidence of `` proven '' or `` probable '' IA ( primary study outcome ) was lower in the GM-PCR group ( 4.2 % vs 13.1 % ; odds ratio , 0.29 [ 95 % confidence interval , .09 -.91 ] ) .


The median interval from the start of monitoring to the diagnosis of IA was lower in the GM-PCR group ( 13 vs 20 days ; P = .022 ) , as well as the use of empirical antifungal therapy ( 16.7 % vs 29.0 % ; P = .038 ) .


Patients in the GM-PCR group had higher proven or probable IA-free survival ( P = .027 ) .


A combined monitoring strategy based on serum GM and Aspergillus DNA was associated with an earlier diagnosis and a lower incidence of IA in high-risk hematological patients .


Clinical Trials Registration.NCT01742026 .


To evaluate the benefits of reducing insulin resistance by early enteral nutrition ( EEN ) in gastric cancer patients after surgery .


Gastric cancer patients were managed to randomly accept traditional total parenteral nutrition ( group A ) or EEN ( group B ) after surgical treatment .


The patients in group B were fed by tubes with 250-500 mL 5 % sodium chloride and glucose injection at 24 h post-surgery , and were fed enteral nutritional emulsion with constant infusion by pump slowly increasing from 20 mL/h to 100 mL/h from 48 h , and then transiting to total enteral nutrition .


Insulin sensitivity of patients was detected by Quicki method before operation and at 24 h , 48 h , 72 h , 120 h and 168 h post-surgery .


A total of 77 patients were enrolled , with 42 patients in group A , and 35 patients in group B. Baseline characteristics , biochemical indexes and operational characteristics were well balanced between two groups .


The time-insulin sensitivity curves of the two groups indicated that IR was present early ( day 1 to day 7 ) in gastric cancer patients and was significantly different between patients who had undergone surgical treatment and those who had not .


Insulin sensitivity ( SI ) of patients in group B were higher than patients in group A with adjusting BMI , age and SI preoperative at 72 h , 120 h and 168 h post-surgery .


The management of EEN can alleviate insulin resistance in gastric cancer patients with surgical treatment .


Acupuncture is a frequently used complementary treatment for ischemic stroke in China but the evidence available from previous randomized trials is inconclusive .


The objective of this study was to assess the efficacy and safety of acupuncture in a more robustly designed larger scale trial .


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


Eight hundred sixty-two hospitalized patients with limb paralysis between 3 to 10 days after ischemic stroke onset were allocated acupuncture plus standard care or standard care alone .


The acupuncture was applied 5 times per week for 3 to 4 weeks .


The primary outcomes were defined as follows : ( 1 ) death/disability according to Barthel index and ( 2 ) death/institutional care at 6 months .


There was a tendency of fewer patients being dead or dependent in acupuncture group ( 80/385 , 20.7 % ) than in control group ( 102/396 , 25.8 % ) at 6 months ( odds ratio , 0.75 ; 95 % confidence interval , 0.54-1 .05 ) .


The benefit was noted in subgroup receiving 10 sessions of acupuncture ( odds ratio , 0.68 ; 95 % confidence interval , 0.47-0 .98 ) .


There was no statistical difference in death or institutional care between the 2 groups ( odds ratio , 1.06 ; 95 % confidence interval , 0.63-1 .79 ) .


Severe adverse events occurred in 7.6 % and 8.3 % of patients in the 2 groups , respectively .


Acupuncture seemed to be safe in the subacute phase of ischemic stroke .


If the potential benefits observed are confirmed in future larger study , the health gain from wider use of the treatment could be substantial .


URL : http://www.chictr.org/en/ .


Unique identifier : ChiCTR-TRC-11001353 .


Biosimilars provide safety , purity , and potency similar to those of a reference biologic product .


An array of protein analytical techniques was used to compare the physicochemical properties of proposed biosimilar filgrastim ( EP2006 ) , US-approved originator filgrastim , and EU-approved originator filgrastim .


Biological characterization involved surface plasmon resonance spectroscopy analyses and in vitro proliferation assays .


A randomized , double-blind , two-way crossover , phase I study in healthy volunteers assessed the pharmacodynamics , pharmacokinetics , and safety profiles of EP2006 and US-approved originator filgrastim ( administered as a single subcutaneous 10 g/kg injection ) .


EP2006 and originator filgrastim ( US and EU approved ) were highly similar with respect to primary , secondary , and tertiary protein structures ; mass , size , purity , charge , and hydrophobicity .


No differences in receptor binding affinity were observed , and all samples demonstrated similar in vitro bioactivity .


In the phase I study , no statistically significant differences between EP2006 and US-approved originator filgrastim were noted in pharmacodynamic or pharmacokinetic parameters , and all confidence intervals were within the equivalence boundaries .


The two products had similar safety profiles .


These studies provide robust evidence of the structural and functional similarity between the proposed biosimilar filgrastim ( EP2006 ) and the US-approved originator filgrastim .


Elevated serum phosphorus and FGF23 are independent cardiovascular risk factors in patients with chronic kidney disease .


In a randomized controlled trial of patients with dyslipidemia assigned to either extended release niacin ( ERN ) alone , ERN combined with the selective prostaglandin D2 receptor subtype 1 inhibitor laropiprant ( ERN-L ) or placebo , niacin lowered serum phosphorus ; however , it is not known if it lowers FGF23 concentrations .


This is an ancillary study to a multicenter , randomized , double-blind , placebo-controlled trial among patients with dyslipidemia and an estimated glomerular filtration rate ( eGFR ) of 30-74 ml/min/1 .73 m ( 2 ) .


Participants were randomized to ERN-L ( n = 162 ) , ERN ( n = 97 ) , or placebo ( n = 68 ) in a 3:2:1 ratio for 24 weeks .


The primary outcome was a change in serum FGF23 concentrations , and secondary outcomes were changes in other mineral metabolism parameters .


Both the ERN and ERN-L groups showed significant declines in serum phosphorus , calcium and calciumphosphorus product at 24 weeks compared to placebo .


A significant decline from baseline ( 10.9 % , p < 0.01 ) in the serum FGF23 concentration was observed in the ERN group compared to placebo , but not in the ERN-L group compared to placebo ( p = 0.36 and 0.97 for ERN-L and placebo , respectively ) , despite equivalent declines in serum phosphorus .


Similarly , the most marked declines in PTH occurred in the ERN-only group versus placebo ; no change in PTH was observed in the ERN-L group .


In this ancillary study of hyperlipidemic patients with an eGFR of 30-74 ml/min/1 .73 m ( 2 ) , ERN alone but not in combination with laropiprant lowered FGF23 and PTH concentrations .


If confirmed , niacin may provide a novel strategy to decrease phosphorus , FGF23 , and PTH concentrations in patients with chronic kidney disease .


To study the efficacy and safety of combined Traditional Chinese Medicine ( TCM ) therapy based on nourishing marrow to improve intellect and reinforcing Qi to activate bloodon mild to moderate Alzheimer 's disease ( AD ) .


Sixty-six patients with AD , whose Mini-Mental State Examination ( MMSE ) score were from 10-24 , were randomized equally into an intervention group and a control group .


The control group was given Aricept ( 5 mg , once daily ) .


The intervention group was further divided into Yang-Qi deficiency ( n = 18 ) and of Yin-Qi deficiency ( n = 15 ) subgroups .


Patients in the Yang-Qi deficiency group were intravenously administered shenfu injection , 60 mL , and deproteinized calf blood injection ( DCBI ) , 1.2 g , once daily .


The Yin-Qi deficiency group was given shenmai injection , 60 mL , and DCBI , 1.2 g , once daily .


Each course lasted 21 days .


Compared with the control group and with pre-treatment in the same group , MMSE , clinical dementia rating , and activities of daily living scale scores in the intervention group were significantly improved ( all P < 0.05 ) .


These metrics mildly improved in the control group compared with before treatment ( P > 0.05 ) .


No adverse effects were observed in any group during treatment .


We found that combined TCM therapy is effective and safe for managing mild to moderate AD .


Chronic post-traumatic headache ( CPTH ) after mild head injury can be difficult to manage .


Research is scarce and successful interventions are lacking.To evaluate the effect of a group-based Cognitive Behavioural Therapy ( CBT ) intervention in relation to headache , pain perception , psychological symptoms and quality of life in patients with CPTH .


Ninety patients with CPTH according to ICHD-2 criteria were enrolled from the Danish Headache Center into a randomized , controlled trial .


Patients were randomly assigned to either a waiting list group or to a nine-week CBT group intervention .


At baseline and after 26weeks all patients completed the Rivermead Post Concussion Symptoms Questionnaire , SF-36 , SCL-90-R and a headache diary .


The CBT had no effect on headache and pressure pain thresholds and only a minor impact on the CPTH patients ' quality of life , psychological distress , and the overall experience of symptoms .


The waiting-list group experienced no change in headache but , opposed to the treatment group , a significant decrease in somatic and cognitive symptoms indicating a spontaneous remission over time .


Our primarily negative findings confirm that management of patients with CPTH still remains a considerable challenge .


Psychological group therapy with CBT might be effective in an earlier stage of CPTH and in less severely affected patients but our findings strongly underline the need for randomized controlled studies to test the efficacy of psychological therapy .


Distraction technology suitable for the perioperative setting is readily available , but there is little evidence to show how it compares with oral midazolam in managing anxiety .


Video glasses , which enable children to view and listen to cartoons and movies , may be used through the completion of inhaled induction .


We compared the efficacy of oral midazolam and behavioral distraction with video glasses in managing preoperative anxiety in children .


In this prospective , randomized study , 96 children aged 4 to 9 years undergoing outpatient surgery were recruited to one of 3 intervention groups receiving midazolam , video glasses , or both .


The Modified Yale Preoperative Anxiety Scale was the primary dependent measure used to assess anxiety at baseline before intervention , 20 minutes later at transport to the operating room ( OR ) , and during mask induction .


There was no significant increase in anxiety score within any group between baseline and OR transport ( P = 0.21 , 0.42 , and 0.57 for midazolam , video glasses , and combined groups , respectively ) .


An increase in anxiety , though not large enough to be clinically significant , was observed from baseline to induction in the midazolam and combined groups ( P = 0.02 and 0.03 ) but not in the video glasses group ( P = 0.38 ) .


Confidence intervals for pairwise comparisons in Modified Yale Preoperative Anxiety Scale changes among groups were all within a clinically significant difference of 15 units .


The use of video glasses and midazolam alone or in combination maintains baseline levels of anxiety at time of transport to the OR and prevents significantly increased anxiety during induction of anesthesia in children .


Video glasses are not inferior to midazolam for preoperative anxiolysis and provide a safe , noninvasive , nonpharmacologic , and pleasant alternative .


We examined the impact of school water , sanitation , and hygiene ( WASH ) interventions on diarrhea-related outcomes among younger siblings of school-going children .


We conducted a cluster-randomized trial among 185 schools in Kenya from 2007 to 2009 .


We assigned schools to 1 of 2 study groups according to water availability .


Multilevel logistic regression models , adjusted for baseline measures , assessed differences between intervention and control arms in 1-week period prevalence of diarrhea and 2-week period prevalence of clinic visits among children younger than 5 years with at least 1 sibling attending a program school .


Among water-scarce schools , comprehensive WASH improvements were associated with decreased odds of diarrhea ( odds ratio [ OR ] = 0.44 ; 95 % confidence interval [ CI ] = 0.27 , 0.73 ) and visiting a clinic ( OR = 0.36 ; 95 % CI = 0.19 , 0.68 ) , relative to control schools .


In our separate study group of schools with greater water availability , school hygiene promotion and water treatment interventions and school sanitation improvements were not associated with differences in diarrhea prevalence between intervention and control schools .


In water-scarce areas , school WASH interventions that include robust water supply improvements can reduce diarrheal diseases among young children .


Fluralaner is a novel systemic insecticide and acaricide that provides long acting efficacy in dogs after a single oral treatment .


This study investigated the safety of oral administration of fluralaner in chewable tablets to dogs at the highest recommended treatment dose and at multiples of this dose .


Thirty-two ( 16 male and 16 female ) healthy 8-week old Beagle dogs weighing 2.0 - 3.6 kg at first administration were included in the study .


Fluralaner was administered on three occasions at 8-week intervals at doses of up to 56 , 168 , and 280 mg fluralaner/kg body weight , equivalent to 1 , 3 , and 5 times the highest recommended treatment dose of fluralaner ; sham dosed dogs served as controls.During the study , all dogs were clinically observed , and their health was carefully monitored including body weight development , food consumption and measurement of hematology , coagulation , clinical chemistry ( including measurement of levels of ACTH and C-reactive protein ) and urinalysis .


Following euthanasia of the dogs , complete gross post mortem examination , including organ weight determination , and histopathological examination of multiple tissues were conducted .


There were no clinical findings related to fluralaner treatment .


Statistically significant differences between the treated groups and the control group were observed for some clinical pathology parameters and organ weights ; none of these findings were considered to be of clinical relevance .


Oral administration of fluralaner at the highest recommended treatment dose ( 56 mg/kg ) at 8-week intervals is well tolerated and has a safety margin of more than five in healthy dogs eight weeks of age or older and weighing at least 2 kg .


Despite the significant positive effect of Highly Active Antiretroviral Therapy on physical and psychosocial well-being of people living with human immunodeficiency virus/acquired immune deficiency syndrome ( HIV/AIDS ) ( PLWHA ) ; decreased physical activity and its associated cardiovascular risk still pose some consequences for health and general well-being .


This study investigated the effect of an 8 week aerobic exercise training on cardiovascular parameters and CD4 cell ( T-cells ) count of PLWHA .


This randomized controlled trial recruited 30 age matched PLWHA who were randomly assigned into exercise group ( EG ) ( n = 15 ) and control group ( CG ) ( n = 15 ) respectively .


The PLWHA were patients receiving treatment in President 's Emergency Plan for AIDS relief at the HIV clinic of the University of Nigeria Teaching Hospital , Nigeria .


The EG in addition to conventional therapy received moderate intensity continuous exercise training ( 60-79 % of the maximum heart rate [ max ] ) of between 45 and 60 min , 3 times/week for 8 weeks , while the CG received conventional therapy involving antiretroviral therapy and counseling only .


Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , maximum oxygen uptake ( VO max ) and CD4 cell count were assessed at baseline ( week 1 ) and week 8 respectively .


Analysis of co-variance and Pearson correlation tests were used in data analysis .


Findings of the study revealed a significant effect ( ANCOVA test ) of moderate intensity continuous exercise training program on , SBP , DBP , VO max and CD4 cell count at P < 0.05 .


Changes in VO max significantly correlated ( Pearson correlation test ) with changes in CD4 cell count ( r = 0.528 ) at P < 0.05 .


Moderate intensity aerobic exercise is an effective complementary therapy in lowering blood pressure and increasing CD4 cell count in PLWHA .


The aim of this study was to investigate whether an acrylic resin-based resilient liner ( ARL ) could improve the satisfaction ratings of complete denture wearers .


The null hypothesis was that no difference exists between the satisfaction ratings of conventional acrylic resin denture ( CARD ) wearers and those of ARL denture ( ARLD ) wearers .


From April 2004 to July 2006 , a randomized controlled trial was conducted at two centers , including 74 edentulous patients .


Of these , 37 patients were each randomly allocated to the ARLD and CARD groups .


All of the patients rated their satisfaction with dentures , including general satisfaction and satisfaction with chewing ability , speaking , cleaning , stability , retention , comfort , and esthetics .


These satisfaction ratings were measured by a 100-mm visual analog scale .


Perceived chewing ability of different foods , divided into five grades , was measured using a questionnaire .


The mastication index ( MI ) was calculated for each grade .


General satisfaction , satisfaction with chewing , and satisfaction with speaking were significantly higher in the ARLD than in the CARD group ( P = .049 , .025 , and .049 , respectively ) .


The chewing satisfaction with maxillary dentures in the ARLD group was significantly higher than that of the CARD group ( P = .02 ) .


No significant difference existed between the MI of the ARLD ( 69.2 17.0 ) and CARD groups ( 66.7 18.7 ) .


Within its limitations , this study showed that the ARL improves a complete denture wearer 's satisfaction ratings .


Digital rectal examination is an essential tool in the evaluation of the rectum .


The aim of this trial was to determine the best position for performing a digital rectal examination .


A total of 321 patients were randomized into `` dorsal '' or `` lateral '' groups in this multicentre randomized controlled trial performed in an outpatient setting .


The primary endpoint was the proportion of patients with a complete digital rectal examination , defined as the examination of the rectum ( upper border of the prostate ) , the entire circumference , and the assessment of the sphincter tone .


The dorsal group included a total of 161 patients ( mean age : 62.3 13.04 years ) , while the lateral group included 160 patients ( mean age : 62.7 14.4 years ) .


The proportion of patients with a complete digital rectal examination was 44 % ( n = 71 ) in the dorsal group and 49 % ( n = 79 ) in the lateral group ( p = 0.3 ) .


The entire circumference of the rectum could be examined in 66 % of the patients ( n = 106 ) in the dorsal group and in 79.5 % of the patients ( n = 128 ) in the lateral group ( p = 0.007 ) .


The intergroup difference in terms of digital rectal examination completion rate was not significant .


In the lateral position , however , the entire circumference of the rectum could be examined more thoroughly .


This large prospective , randomized study was designed to compare the `` mild '' protocol with clomiphene citrate , low-dose gonadotropins and a GnRH-antagonist ( CC/Gn/GnRH-ant protocol ) with the `` long '' protocol with a GnRH-agonist and high-dose Gn for the controlled ovarian hyperstimulation ( COH ) of patients with expected poor ovarian responsiveness undergoing IVF .


A total of 695 women with clinical , endocrine and ultrasound characteristics suggesting a low ovarian reserve and a poor responsiveness to COH were recruited and randomly assigned to receive the CC/Gn/GnRH-ant `` mild '' protocol ( mild group , n = 355 ) or the `` long '' protocol with high-dose Gn ( long group , n = 340 ) .


The `` mild '' stimulation led to significantly shorter follicular phase , lower consumption of exogenous Gn and lower peak estradiol level than the `` long '' regimen .


With the `` long '' protocol , significantly less cycles were cancelled due to the lack of ovarian response ; further , it obtained significantly more oocytes , more mature oocytes , more embryos , and a thicker endometrium .


As for the final IVF outcome , however , the two stimulation regimens obtained comparable implantation rate , clinical pregnancy rate , and ongoing pregnancy rate at 12 weeks .


In conclusion , the `` mild '' CC/Gn/GnRH-ant stimulation protocol is a valid alternative to the long protocol with high Gn dose as it obtains a comparable success rate and requires significantly less medications , with an obvious economical advantage .


To compare oxygen saturations as displayed to caregivers on offset pulse oximeters in the 2 groups of the Canadian Oxygen Trial .


In 5 double-blind randomized trials of oxygen saturation targeting , displayed saturations between 88 % and 92 % were offset by 3 % above or below the true values but returned to true values below 84 % and above 96 % .


During the transition , displayed values remained static at 96 % in the lower and at 84 % in the higher target group during a 3 % change in true saturations .


In contrast , displayed values changed rapidly from 88 % to 84 % in the lower and from 92 % to 96 % in the higher target group during a 1 % change in true saturations .


We plotted the distributions of median displayed saturations on days with > 12hours of supplemental oxygen in 1075 Canadian Oxygen Trial participants to reconstruct what caregivers observed at the bedside .


The oximeter masking algorithm was associated with an increase in both stability and instability of displayed saturations that occurred during the transition between offset and true displayed values at opposite ends of the 2 target ranges .


Caregivers maintained saturations at lower displayed values in the higher than in the lower target group .


This differential management reduced the separation between the median true saturations in the 2groups by approximately 3.5 % .


The design of the oximeter masking algorithm may have contributed to the smaller-than-expected separation between true saturations in the 2 study groups of recent saturation targeting trials in extremely preterm infants .


Gender differences exist in psychiatric disorders ; however , gender has not been well studied in psychotic depression .


This analysis of the largest clinical trial in psychotic depression examined the effects of age and gender on clinical characteristics and predictors of treatment outcome and treatment-associated changes in body mass index ( BMI ) and metabolic measures .


Secondary analyses were performed on data from 259 subjects with major depressive disorder with psychotic features ( DSM-IV-TR ) aged 18-93 years in the double-blind randomized controlled trial of olanzapine plus sertraline versus olanzapine plus placebo for psychotic depression ( Study of Pharmacotherapy of Psychotic Depression ) .


Sociodemographic factors , clinical characteristics , treatment outcome , and treatment-associated changes in BMI and metabolic measures were analyzed by gender and age .


Subjects were enrolled from December 2002 to June 2007 .


Female gender was associated with divorced ( ( 2 ) ( 1 ) = 5.3 , P = .03 ) or widowed ( ( 2 ) ( 1 ) = 8.1 , P .01 ) marital status .


Comorbid anxiety disorders were more common in women than in men ( ( 2 ) ( 1 ) = 4.9 , P = .03 ) .


Hallucinations ( ( 2 ) ( 1 ) = 7.8 , P = .005 ) and delusions with disorganization ( t ( 257 ) = -2.10 , P = .04 ) were significantly associated with female gender , as were higher cholesterol measures ( ( 2 ) ( 1 ) = 7.15 , P = .008 ) .


There were no significant interactions between treatment and gender in terms of change in BMI .


Gender was not associated with treatment response .


This study is the first analysis of gender and age as predictors of treatment outcome and treatment-associated changes in BMI and metabolic adverse effects in psychotic depression .


Gender differences exist in patients with psychotic depression , most notably with regard to the presence of hallucinations .


Female gender was associated with metabolic measures .


Future studies with larger sample sizes may detect small gender differences in treatment outcome and treatment-associated changes in BMI and metabolic measures in psychotic depression .


ClinicalTrials.gov identifier : NCT00056472 .


The Food and Drug Administration can set standards that reduce the nicotine content of cigarettes .


We conducted a double-blind , parallel , randomized clinical trial between June 2013 and July 2014 at 10 sites .


Eligibility criteria included an age of 18 years or older , smoking of five or more cigarettes per day , and no current interest in quitting smoking .


Participants were randomly assigned to smoke for 6 weeks either their usual brand of cigarettes or one of six types of investigational cigarettes , provided free .


The investigational cigarettes had nicotine content ranging from 15.8 mg per gram of tobacco ( typical of commercial brands ) to 0.4 mg per gram .


The primary outcome was the number of cigarettes smoked per day during week 6 .


A total of 840 participants underwent randomization , and 780 completed the 6-week study .


During week 6 , the average number of cigarettes smoked per day was lower for participants randomly assigned to cigarettes containing 2.4 , 1.3 , or 0.4 mg of nicotine per gram of tobacco ( 16.5 , 16.3 , and 14.9 cigarettes , respectively ) than for participants randomly assigned to their usual brand or to cigarettes containing 15.8 mg per gram ( 22.2 and 21.3 cigarettes , respectively ; P < 0.001 ) .


Participants assigned to cigarettes with 5.2 mg per gram smoked an average of 20.8 cigarettes per day , which did not differ significantly from the average number among those who smoked control cigarettes .


Cigarettes with lower nicotine content , as compared with control cigarettes , reduced exposure to and dependence on nicotine , as well as craving during abstinence from smoking , without significantly increasing the expired carbon monoxide level or total puff volume , suggesting minimal compensation .


Adverse events were generally mild and similar among groups .


In this 6-week study , reduced-nicotine cigarettes versus standard-nicotine cigarettes reduced nicotine exposure and dependence and the number of cigarettes smoked .


( Funded by the National Institute on Drug Abuse and the Food and Drug Administration Center for Tobacco Products ; ClinicalTrials.gov number , NCT01681875 . )


As of 2011 , over 9 million working-age adults were receiving federal disability benefits and this number is expected to rise steadily .


Early intervention programs that seek to maintain employment and forestall the receipt of federal disability benefits offer a promising strategy to reduce the growing number of working-age adults on the disability rolls .


Using random assignment , this study examined whether an early intervention program of personal navigators , enhanced medical care , and employment supports can reduce dependence on federal disability benefits for adult workers with mental health conditions .


The study reports multivariate and descriptive findings based on 2279 participants in the Demonstration to Maintain Independence and Employment ( DMIE ) .


Logistic regression analysis was used to estimate program impacts in the treatment group relative to the control group .


Data were integrated from state participant surveys and the SSA Ticket Research File .


The DMIE intervention significantly reduced the percent of participants who received disability benefits after 12 months of enrollment .


Across both states , the difference between the treatment group and control group was 1.1 percentage points ( 2.5 % versus 3.6 % , p < 0.01 ) .


In Texas , the difference was 1.2 percentage points ( 3.2 % versus 4.4 % , p < 0.01 ) .


Early intervention programs with a personal navigator can reduce dependence on federal disability benefits for adult workers with mental health conditions .


Future studies on the cost-effectiveness of such programs are needed .


Although catheter ablation ( CA ) has replaced antiarrhythmic drugs ( AAD ) as first-line treatment in selected patients with atrial fibrillation ( AF ) , optimal treatment of recurrent atrial tachycardia ( AT ) after AF ablation remains unclear .


This parallel randomized controlled study compared CA vs. AAD for recurrent AT after persistent AF ablation .


Two-hundred and one patients ( aged 59.1 10.9 years , 68.7 % male ) with recurrent AT after persistent AF ablation were enrolled and randomized to either CA ( n = 101 ) or AAD ( n = 100 ) treatment .


Primary endpoint was freedom from recurrent atrial tachyarrhythmia ( ATa , including AT and AF ) at 24-month follow-up .


Composite secondary endpoints comprised procedural complications , long-term morbidity and improvement in quality of life ( QoL ) .


On an intention-to-treat basis , the CA group had a higher rate of freedom from recurrent ATa ( 56.4 vs. 34.0 % ; P = 0.001 ) .


Adjusted Cox regression analysis showed a significant treatment effect with a hazard ratio of 0.538 ( 95 % CI : 0.355-0 .816 ) in favour of CA .


There was a higher proportion of periprocedural complications in the CA group ( 7.9 vs. 0 ; P = 0.012 ) , and of long-term adverse events in the AAD group ( 10.9 vs. 24.0 % ; P = 0.014 ) .


Quality of life was significantly higher for CA .


This study demonstrates superiority of CA over AAD for recurrent AT after persistent AF ablation with regard to SR maintenance , long-term safety and QoL improvement .


However , CA use might be limited by a higher risk for periprocedural complications .


Fluralaner is a novel systemic ectoparasiticide for dogs providing long-acting flea - and tick-control after a single oral dose .


This study investigated the safety of oral administration of fluralaner at 3 times the highest expected clinical dose to Multi Drug Resistance Protein 1 ( MDR1 ( - / - ) ) gene defect Collies .


Sixteen Collies homozygous for the MDR1 deletion mutation were included in the study .


Eight Collies received fluralaner chewable tablets once at a dose of 168 mg/kg ; eight sham dosed Collies served as controls .


All Collies were clinically observed until 28 days following treatment .


No adverse events were observed subsequent to fluralaner treatment of MDR1 ( - / - ) Collies at three times the highest expected clinical dose .


Fluralaner chewable tablets are well tolerated in MDR1 ( - / - ) Collies following oral administration .


Many people with clinically significant chronic obstructive pulmonary disease ( COPD ) remain undiagnosed worldwide .


There are a number of small studies which have examined possible methods of case finding through primary care , but no large RCTs that have adequately assessed the most cost-effective approach .


In this study , using a cluster randomised controlled trial ( RCT ) in 56 general practices in the West Midlands , we plan to investigate the effectiveness and cost-effectiveness of a Targeted approach to case finding for COPD compared with routine practice .


Using an individual patient RCT nested in the Targeted arm , we plan also to compare the effectiveness and cost-effectiveness of Active case finding using a postal questionnaire ( with supplementary opportunistic questionnaires ) , and Opportunistic-only case finding during routine surgery consultations.All ever-smoking patients aged 40-79 years , without a current diagnosis of COPD and registered with participating practices will be eligible .


Patients in the Targeted arm who report positive respiratory symptoms ( chronic cough or phlegm , wheeze or dyspnoea ) using a brief questionnaire will be invited for further spirometric assessment to ascertain whether they have COPD or not .


Post-bronchodilator spirometry will be conducted to ATS standards using an Easy One spirometer by trained research assistants.The primary outcomes will be new cases of COPD and cost per new case identified , comparing targeted case finding with routine care , and two types of targeted case finding ( active versus opportunistic ) .


A multilevel logistic regression model will be used to model the probability of detecting a new case of COPD for each treatment arm , with clustering of patients ( by practice and household ) accounted for using a multi-level structure.A trial-based analysis will be undertaken using costs and outcomes collected during the trial .


Secondary outcomes include the feasibility , efficiency , long-term cost-effectiveness , patient and primary care staff views of each approach .


This will be the largest RCT of its kind , and should inform how best to identify undiagnosed patients with COPD in the UK and other similar healthcare systems .


Sensitivity analyses will help local policy-makers decide which sub-groups of the population to target first .


Current controlled trials ISRCTN14930255 .


To determine and correlate the effect of clomiphene citrate , Letrozole in women undergoing infertility treatment on the gingival inflammatory status .


The present study is a randomized controlled clinical trial which consisted of 26 women using CC for three menstrual cycles , 26 women using CC for more than three cycles , 26 women using Letrozole .


All subjects were clinically examined for plaque levels ( Plaque Index ) , gingival inflammation , bleeding on probing ( Gingival Index , Sulcus Bleeding Index ) .


Scaling was done to all patients and all periodontal parameters were reassessed 1 month after scaling .


The results were compared with a control group of 26 women matched for age , educational status and professional level , and oral habits and who had never used ovulation drugs .


Baseline scores of all the test groups showed higher amount of plaque levels and inflammation compared to control .


( p < 0.05 ) .


After scaling a significant reduction in inflammation was observed in all the test groups along with the control group ( p < 0.0001 ) , but women using the drugs showed persistence of inflammation compared to control ( p < 0.01 ) .


It can be concluded from the present study that the presence of elevated levels of hormones due to the effect of ovulation induction drugs may be the reason for the gingival inflammation in test groups .


To evaluate the safety and efficacy of therapy with etanercept and methotrexate ( MTX ) in patients with active rheumatoid arthritis ( RA ) and mild hepatitis C virus ( HCV ) infection .


In this prospective open study , 29 patients with active RA were randomly assigned to receive therapy with MTX alone , etanercept alone , or a combination of MTX and etanercept , and monitored up to 54 weeks .


The primary endpoint was safety ; secondary aims were efficacy as defined by the 44-joint Disease Activity Score ( DAS44 ) and health assessment questionnaire ( HAQ ) .


Serum liver enzymes and HCV viral load were serially measured .


In the whole cohort , aspartate aminotransferase ( AST ) serum levels were ( mean SD ) 35 3 at entry , 39 5 , 41 7 , and 38 4 at 14 , 30 , and 54 weeks , respectively ; alanine aminotransferase ( ALT ) serum levels were 43 5 at entry , 47 5 , 53 9 , and 50 6 at 14 , 30 , and 54 weeks , respectively .


HCV viral load was 5.6 0.5 at entry , 5.9 0.6 , 5.7 0.3 , and 5.6 0.6 at 14 , 30 , and 54 weeks , respectively .


AST and ALT did not significantly change in all 3 arms of treatment , nor did HCV viral load .


A significant reduction of DAS44 ( p < 0.01 ) and HAQ ( p < 0.04 ) was detected at 54 weeks compared to baseline .


No patient discontinued the therapy because of worsening of liver disease .


This study showed that patients with RA and chronic HCV and mild hepatitis may be successfully treated with etanercept and MTX without increasing the risk of hepatotoxicity and HCV replication .


ClinicalTrials.gov Identifier NCT01543594 .


Despite suppressive antiretroviral therapy ( ART ) , increased levels of immune activation persist in HIV-infected subjects .


Statins have anti-inflammatory effects and may reduce immune activation in HIV disease .


Stopping Atherosclerosis and Treating Unhealthy bone with RosuvastatiN in HIV ( SATURN-HIV ) is a randomized , double-blind placebo-controlled trial assessing the effect of rosuvastatin ( 10 mg daily ) on markers of cardiovascular risk and immune activation in ART-treated patients .


T-cell activation was measured by expression of CD38 , HLA-DR , and PD1 .


Monocyte activation was measured with soluble markers ( sCD14 and sCD163 ) and by enumeration of monocyte subpopulations and tissue factor expression .


Markers of systemic and vascular inflammation and coagulation were also measured .


SATURN-HIV is registered on clinicaltrials.gov ( identifier : NCT01218802 ) .


Rosuvastatin , compared with placebo , reduced sCD14 ( -10.4 % vs 0.5 % , P = 0.006 ) , lipoprotein-associated phospholipase A2 ( -12.2 % vs -1.7 % , P = 0.0007 ) , and IP-10 ( -27.5 vs -8.2 % , P = 0.03 ) levels after 48 weeks .


The proportion of tissue factor-positive patrolling ( CD14CD16 ) monocytes was also reduced by rosuvastatin ( -41.6 % ) compared with placebo ( -18.8 % , P = 0.005 ) .


There was also a greater decrease in the proportions of activated ( CD38HLA-DR ) T cells between the arms ( -38.1 % vs -17.8 % , P = 0.009 for CD4 cells , and -44.8 % vs -27.4 % , P = 0.003 for CD8 cells ) .


Forty-eight weeks of rosuvastatin treatment reduced significantly several markers of inflammation and lymphocyte and monocyte activation in ART-treated subjects .


Honey has been shown to have beneficial effects on the glucose and lipid profiles in patients at high risk of heart diseases .


Therefore , this study was carried out to investigate the effects of natural honey on blood glucose and lipid profile in healthy individuals .


A randomized controlled trial was carried out in the Army Medical College , Rawalpindi , Pakistan , spanning 4 weeks , that is , from 15th Feb-15th March 2009 .


A total of 70 healthy young boarders of the same college were included in the study and randomly divided into two groups of 35 each using random number table .


Seventy gram ( 70 g ) of honey was given to each individual in the experimental group daily for a period of 4 weeks while control group was kept on the same diet as that of experimental group except honey .


The fasting glucose , total cholesterol , low density lipoprotein ( LDL ) , high density lipoprotein ( HDL ) and triglyceride ( TG ) levels were measured before and after the experiment .


The fasting glucose levels in both groups were raised .


However , the increase in the experimental group was significantly less than that in the control group ( p < 0.05 ) .


The levels of total cholesterol , LDL and triglycerides in the control group increased while those in the experiment group decreased significantly ( p < 0.05 ) , while HDL levels were decreased in the former and increased in the latter group ( p < 0.05 ) .


Natural honey consumption significantly limits the rise in blood glucose along with a significant decrease in the levels of total cholesterol , LDL and triglycerides , and increase HDL in young healthy adults .


Persistent and long-standing persistent atrial fibrillation ( AF ) often requires extensive and/or repeat radiofrequency ( RF ) ablation procedures .


The Tailored Treatment of Persistent Atrial Fibrillation ( TTOP-AF ) study assessed the effectiveness and safety of the phased RF system in a randomized controlled comparison of medical therapy against phased RF ablation for the management of persistent and long-standing persistent AF .


Patients who had failed at least 1 antiarrhythmic drug ( AAD ) were randomized ( 2:1 ) to ablation management ( AM ) or medical management ( MM ) .


AM patients were allowed up to 2 ablations .


Index and retreatment procedures consisted of pulmonary vein isolation and ablation of complex fractionated atrial electrograms .


MM patients received AAD changes and/or cardioversion .


The primary end points of the TTOP-AF study included chronic effectiveness and safety at 6 months and acute safety within 7 days of ablation .


At 6 months , a greater proportion of AM patients achieved effectiveness off AAD ( 77 of 138 [ 55.8 % ] ) compared to MM patients ( 19 of 72 [ 26.4 % ] ) ( P < .0001 ) .


Acutely , 92.8 % ( 128/138 ) of the procedures were successful while 12.3 % ( 17/138 ) experienced a serious procedure and/or device-related adverse event .


The predefined acute safety end point was not met .


The proportion of patients with chronic safety events did not differ significantly between groups .


Catheter ablation of persistent/long-standing persistent AF with the phased RF ablation system is effective with greater reduction of AF compared with MM .


More intense anticoagulation strategies , careful attention to catheter placement relative to the pulmonary vein ostia , and elimination of electrode interaction are expected to reduce the risk of stroke , pulmonary vein stenosis , and asymptomatic cerebral emboli .


Chronic fatigue syndrome ( CFS ) or myalgic encephalomyelitis ( ME ) is relatively common in children with limited evidence for treatment .


The Phil Parker Lightning Process ( LP ) is a trademarked intervention , which > 250 children use annually .


There are no reported studies investigating the effectiveness or possible side effects of LP .


The trial population was drawn from the Bath and Bristol NHS specialist paediatric CFS or ME service .


The study was designed as a pilot randomized trial with children ( aged 12 to 18 years ) comparing specialist medical care with specialist medical care plus the Lightning Process .


Integrated qualitative methodology was used to explore the feasibility and acceptability of the recruitment , randomization and interventions .


A total of 56 children were recruited from 156 eligible children ( 1 October 2010 to 16 June 2012 ) .


Recruitment , randomization and both interventions were feasible and acceptable .


Participants suggested changes to improve feasibility and acceptability and we incorporated the following in the trial protocol : stopped collecting 6-week outcomes ; introduced a second reminder letter ; used phone calls to collect primary outcomes from nonresponders ; informed participants about different approaches of each intervention and changed our recommendation for the primary outcome for the full study from school attendance to disability ( SF-36 physical function subscale ) and fatigue ( Chalder Fatigue Scale ) .


Conducting randomized controlled trials ( RCTs ) to investigate an alternative treatment such as LP is feasible and acceptable for children with CFS or ME .


Feasibility studies that incorporate qualitative methodology enable changes to be made to trial protocols to improve acceptability to participants .


This is likely to improve recruitment rate and trial retention .


Feasibility study first randomization : 29 September 2010 .


Trial registration : Current Controlled Trials ISRCTN81456207 ( 31 July 2012 ) .


Full trial first randomization : 19 September 2012 .


Asthma guidelines recommend prescription of inhaled corticosteroids at a reduced dosage in children compared to older patients in order to minimize the systemic exposure and risk of unwanted side effects .


In children , pressurized metered dose inhalers ( pMDI ) are recommended in combination with a valved holding chamber ( VHC ) to overcome the problem of coordinating inhalation with actuation .


However , the influence of age and body size on the systemic exposure of drugs to be administered via a pMDI with VHC is still not fully elucidated .


Therefore , we aimed to compare the systemic exposure to the active ingredients of a fixed combination of beclometasone-dipropionate/formoterol-fumarate administered via pMDI with VHC in children , adolescents and adults .


The pharmacokinetics of formoterol and beclometasone-17-monopropionate ( active metabolite of beclometasone-dipropionate ) was evaluated over 8h from three studies , each performed in a different age and body size group .


Children ( 7-11 years , n = 20 ) , adolescents ( 12-17 years , n = 29 ) and adults ( 18 years , n = 24 ) received a single dose of beclometasone/formoterol ( children : 200g/24g , adolescents and adults : 400g/24g ) via pMDI with AeroChamber Plus .


The systemic exposure in children in comparison to adolescents was equivalent for formoterol while it was halved for beclometasone-17-monopropionate in accordance with the halved dose of beclometasone administered in children ( 90 % CIs within 0.8-1 .25 for formoterol and 0.4-0 .625 for beclometasone-17-monopropionate ) .


The systemic exposure to beclometasone-17-monopropionate and formoterol was equivalent between adolescents and adults .


The systemic exposure to the active ingredients of a fixed dose combination of beclometasone/formoterol administered via pMDI with AeroChamber Plus correlates with the nominal dose independently of patient age and body size .


Thus , dose reduction in relation to age when using a pMDI with VHC may be unnecessary for reducing the systemic exposure in children .


Post-tonsillectomy pain is a notable concern and thermal injury produced by electric surgical devices is considered a main cause .


Intraoperative cooling of the tonsillar fossa and pharyngeal mucosa with cold water has effectively reduced postoperative pain , but no studies have fully evaluated the effects of this technique with a proper study design .


We assessed mucosal cooling in two groups of patients undergoing the same surgical technique by a single surgeon , with one group receiving cold-water cooling and the other group as a control .


Forty patients who underwent monopolar electrocautery tonsillectomy were randomly assigned to two groups ( n = 20 for each group ) .


Group 1 received cooling of the tonsillar fossa and pharyngeal mucosa with 4 C saline just after removal of each tonsil whereas Group 2 did not receive cooling .


Postoperative pain was recorded on operation day and 1 , 2 , 4 , 7 , and 10 days postoperatively .


Post-tonsillectomy pain , return to normal diet , and incidence of postoperative bleeding were compared between the groups .


Post-tonsillectomy pain on 6 selected days and overall pain during the 10-day follow-up period were significantly lower in Group 1 .


However , return to normal diet and incidence of postoperative bleeding did not differ significantly between the groups .


Intraoperative application of cold water after tonsillectomy significantly reduced postoperative pain .


We recommend cooling the tonsillar fossa and pharyngeal mucosa with cold water during tonsillectomy to easily and effectively reduce post-tonsillectomy pain .


Informed consent ( IC ) comprehension is suboptimal .


Repeat back ( RB ) - asking the patient to repeat in their own words key elements of the consent-is believed to improve the consent process .


This study aims to assess the impact of RB on patient perceptions of surgical informed consent .


Secondary analysis of a randomized trial .


Elective surgical patients were consented using iMedConsent , the VA 's computer-based IC platform .


Patients were randomized to RB ( IC could not be signed until the patient satisfactorily expressed key elements ) or standard iMedConsent ( no RB ) .


A questionnaire was given immediately after IC assessing time for decision , satisfaction with and ease of understanding consent , and the amount of information provided about the proposed surgery ( e.g. , indications , benefits , risks , and alternatives ) .


Groups were compared with tests .


We enrolled 575 subjects ( 276 RB and 299 no RB ) ; 92 % were men with a mean age of 61.6 years and high school level reading ability .


The groups were comparable in their perceptions regarding time to make a decision ( RB 88 % Strongly Agree ( SA ) , no RB 88 % SA ; P = 0.61 ) , satisfaction with consent ( RB 90 % SA , no RB 87 % SA ; P = 0.27 ) , ease of understanding ( RB 69 % SA , no RB 67 % SA ; P = 0.73 ) receipt of the right amount of information regarding the indications ( RB 85 % SA , no RB 87 % ; P = 0.61 ) , the benefits ( RB 87 % SA , no RB 86 % SA ; P = 0.29 ) , and the risks ( RB 87 % SA , no RB 84 % SA ; P = 0.19 ) of surgery .


More of the RB group felt they received the right amount of information about alternatives to surgery ( RB 80 % SA ) than did the no RB group ( 69 % SA ) ; P = 0.01 .


Patients were highly satisfied with RB during surgical IC RB is not detrimental to the consent process and may improve informed consent for surgery .


Clinical Trials Identifier NCT00288899 http://www.clinicaltrials.gov .