Those in the ABC group showed a steeper decline in cortisol across the day ( mean , -0.31 g/dL ) than those in the control group , who showed a blunted cortisol rhythm ( mean , -0.12 g/dL ) ( = -0.19 ; P = .02 ) .


Differences in cortisol production between the experimental and control groups persisted at the preschool follow-up and resembled differences initially observed 3 months following intervention .


This is encouraging evidence that the ABC intervention for Child Protective Services-referred children may have long-lasting effects on a physiological stress system critical for health and adjustment .


clinicaltrials.gov Identifier : NCT02093052 .


Middle Eastern female immigrants are at an increased risk of vitamin D deficiency and their response to prescribed vitamin D dosages may not be adequate and affected by other factors .


The objectives were to determine vitamin D deficiency and its determinants in Middle Eastern women living in Auckland , New Zealand ( Part-I ) , and to determine serum 25-hydroxyvitamin D ( serum-25 ( OH ) D ) response to two prescribed vitamin D dosages ( Part-II ) in this population .


Women aged 20 ( n = 43 ) participated in a cross-sectional pilot study during winter ( Part-I ) .


In Part-II , women aged 20-50 years ( n = 62 ) participated in a randomised , double-blind placebo-controlled trial consuming monthly either 50,000 , 100,000 IU vitamin D3 or placebo for 6 months ( winter to summer ) .


All women in Part-I and 60 % women in Part-II had serum-25 ( OH ) D < 50nmol/l .


Serum-25 ( OH ) D was higher in prescribed vitamin D users than nonusers ( P = 0.001 ) and in Iranians than Arab women ( P = 0.001 ; Part-I ) .


Mean ( s.d. ) serum-25 ( OH ) D increased in all groups ( time effect , P < 0.001 ) and differed between groups ( time dosage interaction , P < 0.001 ; 50,000 IU : from 44.016.0 to 70.015.0 nmol/l ; 100,000 IU : 48.011.0 to 82.017.0 nmol/l ; placebo : 45.018.0 to 54.018.0 nmol/l ) .


Only 32 % and 67 % achieved serum-25 ( OH ) D75nmol/l with 50,000 and 100,000 IU/month , respectively .


Predictors of 6-month change in serum-25 ( OH ) D were dose ( B-coefficients .


e. ; 14.12.4 , P < 0.001 ) , baseline serum-25 ( OH ) D ( -0.60.1 , P < 0.001 ) and body fat percentage ( -0.70.3 , P = 0.01 ) .


Vitamin D deficiency/insufficiency is highly prevalent in this population .


Monthly 100,000 IU vitamin D for 6 months is more effective than 50,000 IU in achieving serum-25 ( OH ) D 75nmol/l ; however , a third of women still did not achieve these levels .


Growing , small , peripheral , pulmonary nodules in patients at high risk for lung cancer lead to requests for video-assisted thoracoscopic ( VATS ) resection for pathologic diagnosis .


The purpose of this randomized controlled trial was to determine if preoperative localization using percutaneously placed computed tomography ( CT ) - guided platinum microcoils decreases the need for thoracotomy or VATS anatomic resection ( segmentectomy/lobectomy ) for diagnosis .


Patients with undiagnosed nodules of 15 mm or less were randomized to either no localization or preoperative microcoil localization .


Coils were placed with the distal end deep to the nodule and the superficial end coiled on the visceral pleural surface with subsequent visualization by intraoperative fluoroscopy and VATS.Nodules were removed by VATS wedge excision using endostaplers .


The primary outcome was a VATS wedge excision for pathologic diagnosis of the nodule without the need for either thoracotomy or VATS anatomic resection .


Sixty patients were randomized and 56 underwent surgery between March 2010 and June 2012 .


Twenty-nine underwent microcoil localization and 27 did not .


The baseline characteristics ( age , sex , forced expiratory volume in the first second of expiration , nodule size/depth ) were similar .


The coil group had a higher rate of successful diagnosis with VATS wedge resection alone ( 27/29 vs 13/27 ; P < .001 ) , decreased operative time to nodule excision ( 37 39 vs 100 67 minutes ; P < .001 ) , and reduced stapler firings ( 3.7 2.0 vs 5.9 31 ; P = .003 ) with no difference in total costs .


Pathologic diagnoses included 14 benign nodules , 32 primary lung malignancies , and 10 metastases .


There were no clinically significant complications related to the coil placement or wedge resection .


Preoperative CT-guided microcoil localization decreases the need for thoracotomy or VATS anatomic resection for the diagnosis of small peripheral pulmonary nodules .


Glycolic acid ( GA ) peels are frequently performed as adjuvants to the treatment of facial acne .


There have been few clinical trials reported of GA peels for acne in people with darker skin .


To determine the safety and efficacy of GA peels in the treatment of moderate acne vulgaris in Asian skin .


In this prospective , randomized , double-blind , placebo-controlled , split-face clinical trial , 26 patients with moderate acne were treated with 40 % GA ( pH 2.0 ) on half of the face and placebo on the other half .


The procedure was performed five times at 2-week intervals .


The GA sides had statistically significant reductions in acne lesions at each time point from baseline values .


There were statistically significant differences between the GA and placebo sides .


The GA sides had better responses for noninflammatory lesions than for inflammatory lesions .


In bioengineering measurements , sebum levels were statistically significantly reduced after the initiation of therapy on both sides at weeks 8 and 10 , but there were no statistically significant differences between the two sides .


Forty percent GA peels significantly improved moderate acne in this study .


It is effective and safe in Asians .


Self-management is promoted as a strategy for improving outcomes for serious mental illness as well as for chronic general medical conditions .


This study evaluated the feasibility and effectiveness of an eight-month program combining training in self-management for both psychiatric and general medical illness , including embedded nurse care management .


Participants were 71 middle-aged and older adults ( mean age = 60.3 6.5 ) with serious mental illness and chronic general medical conditions who were randomly assigned to receive integrated Illness Management and Recovery ( I-IMR ) ( N = 36 ) or usual care ( N = 35 ) .


Feasibility was determined by attendance at I-IMR and nurse sessions .


Effectiveness outcomes were measured two and six months after the intervention ( ten - and 14-month follow-ups ) and included self-management of psychiatric and general medical illness , participation in psychiatric and general medical encounters , and self-reported acute health care utilization .


I-IMR participants attended 15.8 9.5 I-IMR and 8.2 5.9 nurse sessions , with 75 % attending at least ten I-IMR and five nurse sessions .


Compared with usual care , I-IMR was associated with greater improvements in participant and clinician ratings for psychiatric illness self-management , greater diabetes self-management , and an increased preference for detailed diagnosis and treatment information during primary care encounters .


The proportion of I-IMR participants with at least one psychiatric or general medical hospitalization decreased significantly between baseline and ten - and 14-month follow-ups .


I-IMR is a feasible intervention for this at-risk group and demonstrated potential effectiveness by improving self-management of psychiatric illness and diabetes and by reducing the proportion of participants requiring psychiatric or general medical hospitalizations .


To compare contrast sensitivity , visual acuity ( VA ) , and halos in subjects bilaterally implanted with 1 of 3 FDA-approved presbyopia-correcting intraocular lenses .


Prospective , randomized , partially masked , multicenter clinical trial .


Seventy-eight subjects were randomized sequentially for bilateral implantation with the Crystalens AO ( Bausch & Lomb Surgical ) , AcrySof IQ ReSTOR +3.0 ( Alcon Laboratories ) , or Tecnis Multifocal ( Abbott Medical Optics ) lenses .


Subjects were evaluated through visit 4 ( 4 to 6months after surgery ) with the following monocular and binocular assessments : high - and low-contrast VA , contrast sensitivity without glare , halos or starbursts , defocus curves , optical scatter , retinal point spread function , and safety .


The Crystalens AO and ReSTOR +3.0 demonstrated better monocular and binocular contrast sensitivity without glare at low to mid spatial frequencies compared with the Tecnis Multifocal lens .


Binocular uncorrected distance VA was not significantly different between the 3 lenses .


The Crystalens AO had significantly better binocular low-contrast distance-corrected VA than the ReSTOR +3.0 and better mean monocular low-contrast DCVA than the Tecnis Multifocal lens .


The Crystalens AO demonstrated significantly better monocular and binocular uncorrected and distance-corrected intermediate VA than the ReSTOR +3.0 or Tecnis Multifocal lenses .


The ReSTOR +3.0 lens had significantly better monocular and binocular uncorrected and distance-corrected near VA tested at 40cm compared with the Crystalens AO and Tecnis Multifocal lens .


The Crystalens AO elicited significantly less halos than the Tecnis Multifocal lens and less optical scatter than the ReSTOR +3.0 or Tecnis Multifocal lens .


The Crystalens AO had statistically better uncorrected intermediate VA and distance-corrected intermediate VA than the ReSTOR +3.0 or Tecnis Multifocal lenses and fewer photic phenomenon than the Tecnis Multifocal lens .


Both multifocals had better distance-corrected near VA and uncorrected near VA than the Crystalens AO .


These findings may guide intraocular lens selection for individual patients seeking to optimize vision at specific vergences or lighting conditions .


This study sought to evaluate the efficacy of the isolated use of tacrolimus compared with the combined use of tacrolimus and olopatadine for the treatment of severe vernal keratoconjunctivitis ( VKC ) .


Twenty-one patients with severe VKC were randomized into two groups : one treated with 0.03 % tacrolimus ointment combined with 1 % olopatadine ophthalmic solution and the other with 0.03 % tacrolimus ointment combined with placebo eye drops .


The clinical signs and symptoms were graded from 0 to 3 , and the efficacy of treatment was determined by the difference between the score at the beginning of treatment and after 30 days .


The clinical impression of improvement as perceived by the evaluator and the self-assessment provided by the patient were scored at day 30 of treatment and compared between the groups .


The scores for symptoms decreased between the assessments in both groups ( -1.73.9 in the experimental group ; -0.61.6 in the control group ) , with no significant difference between groups ( P = 0.205 ) .


The scores for clinical signs decreased between the assessments in the experimental group ( -1.12.7 ) and increased in the control group ( 0.30.9 ) but with no significant differences ( P = 0.205 ) .


There was no significant difference between the groups regarding the self-assessment ( P = 0.659 ) and the clinical impression of the evaluator ( P = 0.387 ) .


The isolated use of tacrolimus and the combined use of tacrolimus and olopatadine seems to have the same efficacy , although controlled studies with larger samples are required to confirm this hypothesis .


The determination of dosing regimens for the treatment of malaria is largely empirical and thus a better understanding of the pharmacokinetic/pharmacodynamic properties of antimalarial agents is required to assess the adequacy of current treatment regimens and identify sources of suboptimal dosing that could select for drug-resistant parasites .


Mefloquine is a widely used antimalarial , commonly given in combination with artesunate .


Mefloquine pharmacokinetics was assessed in 24 healthy adults and 43 patients with Plasmodium falciparum malaria administered mefloquine in combination with artesunate .


Population pharmacokinetic modelling was conducted using NONMEM .


A two-compartment model with a single transit compartment and first-order elimination from the central compartment most adequately described mefloquine concentration-time data .


The model incorporated population parameter variability for clearance ( CL/F ) , central volume of distribution ( VC/F ) and absorption rate constant ( KA ) and identified , in addition to body weight , malaria infection as a covariate for VC/F ( but not CL/F ) .


Monte Carlo simulations predict that falciparum malaria infection is associated with a shorter elimination half-life ( 407 versus 566 h ) and T > MIC ( 766 versus 893 h ) .


This is the first known population pharmacokinetic study to show falciparum malaria to influence mefloquine disposition .


Protein binding , anaemia and other factors may contribute to differences between healthy individuals and patients .


As VC/F is related to the earlier portion of the concentration-time profiles , which occurs during acute malaria , and CL/F is more related to the terminal phase during convalescence after treatment , this may explain why malaria was found to be a covariate for VC/F but not CL/F .


Tinnitus occurs in a large part of the general population with prevalences ranging from 10 % to 15 % in an adult population .


One subtype is cervicogenic somatic tinnitus , arising from cervical spine dysfunctions , justifying cervical spine assessment and treatment .


This study aims to investigate the effect of a standardized physical therapy treatment , directed to the cervical spine , on tinnitus .


Additionally , a second aim is to identify a subgroup within the tinnitus population that benefits from physical therapy treatment .


This study is designed as a randomized controlled trial with delayed treatment design .


Patients with severe subjective tinnitus ( Tinnitus Functional Index ( TFI ) between 25 and 90 points ) , in combination with neck complaints ( Neck Bournemouth Questionnaire ( NBQ ) > 14 points ) will be recruited from the University Hospital of Antwerp .


Patients suffering from tinnitus with clear otological etiologies , severe depression , traumatic cervical spine injury , tumors , cervical spine surgery , or conditions in which physical therapy is contra-indicated , will be excluded.After screening for eligibility , baseline data such as TFI , NBQ , and a set of cervical biomechanical and sensorimotor tests will be collected .


Patients are randomized in an immediate therapy group and in a group with a delayed start of therapy by 6 weeks .


Patients will receive physical therapy with a maximum of 12 sessions of 30 min for a 6-week program .


Data from the TFI and NBQ will be collected at baseline ( week 0 ) , at the start of therapy ( weeks 0 or 6 ) , at the end of therapy ( weeks 6 or 12 ) , 6 weeks after therapy ( weeks 12 or 18 ) , and 3 months after therapy ( weeks 18 or 24 ) .


Secondary outcome measures will be collected at baseline and 6 weeks after the therapy ( weeks 12 or 18 ) , as the maximal therapy effect on the cervical spine dysfunctions is expected at that moment .


This study is the first to investigate the effect of a standardized physical therapy treatment protocol on somatic tinnitus with a prospective comparative delayed design and with blinded evaluator for baseline , end of therapy , and 6 and 12 weeks after therapy .


12 September 2013 , ClinicalTrials.gov : NCT02016313 .


Inflammation is involved in development , progression , and complications of atherosclerotic disease .


Clinical studies have indicated that the level of monocyte chemoattractant protein 1 ( MCP-1 ) , IL-18 , and adhesion molecules correlates with the severity of atherosclerosis and can predict future cardiovascular events .


Experimental studies have shown pentoxifylline ( PTX ) reduces these factors in animal models .


The purpose of the present pilot study was to evaluate effect of PTX on a group of inflammatory biomarkers in patients with coronary artery disease ( CAD ) .


Forty patients with angiographically documented CAD , who fulfilled inclusion and exclusion criteria , were entered in the double-blind , randomized , pilot clinical study .


The patients were randomly given PTX ( 400 mg three times daily ) or placebo ( 3 tab/day ) for 2 months .


Serum concentrations of MCP-1 , IL-18 , intercellular adhesion Molecule 1 ( ICAM-1 ) , and vascular cell adhesion molecule 1 ( VCAM-1 ) were measured before and at the end of intervention by enzyme-linked immunosorbant assay .


Our study showed that the serum levels of ICAM-1 and VCAM-1 was decreased in the study population after two-month treatment ( P < 0.05 ) .


Based on the results of our pilot study , administration of PTX in CAD patients significantly decreases adhesion molecules levels .


The incremental prognostic value of high-sensitive troponin T ( hs-cTnT ) in heart failure ( HF ) beyond that of high-sensitivity C-reactive protein and amino-terminal probrain natriuretic peptide is debated .


We examined the prognostic value of hs-cTnT in a subgroup of patients from the Controlled Rosuvastatin Multinational Trial in HF ( CORONA ) study .


Hs-cTnT as a risk factor for the primary end point ( cardiovascular death , nonfatal myocardial infarction , and nonfatal stroke ; n = 356 ) , as well as all-cause mortality ( n = 366 ) , cardiovascular mortality ( n = 299 ) , and the composite of cardiovascular mortality and hospitalization from worsening of HF ( n = 465 ) , was investigated in 1245 patients ( 60 years ; New York Heart Association [ NYHA ] class II-IV , ischemic systolic HF ) randomly assigned to 10 mg rosuvastatin or placebo .


In multivariable analyses , adjusting for left ventricular ejection fraction , NYHA class , age , body mass index , diabetes mellitus , sex , intermittent claudication , heart rate , estimated glomerular filtration rate , apolipoprotein B/apolipoprotein A-1 ratio , amino-terminal probrain natriuretic peptide , high-sensitivity C-reactive protein , and hs-cTnT ( both dichotomized according to the 99th percentile and as a continuous variable ) was associated with all end points ( primary end point : hazard ratio , 1.87 and 1.51 , respectively , per SD change ; P < 0.001 ; all other end points : hazard ratio , 1.39-1 .70 ) .


However , improved discrimination as assessed by C-statistics was only seen for the primary end point and all-cause mortality .


Elevated hs-cTnT levels provide strong and independent prognostic information in older patients with chronic ischemic HF .


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


Unique identifier : NCT00206310 .


To assess the impact of listening to preferred music on relieving male patients ' pain and anxiety during flexible cystoscopy .


A total of 124 male patients were admitted to our hospital for flexile cystoscopy by a single urologist between January 2013 and September 2013 and randomized to two equal groups .


Group 2 included 62 patients who could select and listen to their preferred music during flexible cystoscopy .


Group 1 included 62 patients who were unable to listen to the music .


All patients were administered the same amount of lidocaine ( 10 mL ) for 3 minutes for local anesthesia before flexible cystoscopy .


A visual analog scale ( VAS ) ranging from 0 to 10 was used to assess patients ' pain feeling after the cystoscopy procedure .


Anxiety levels were calculated according to the State Instrument of State-Trait Anxiety Inventory ( STAI-S ) , and the pulse rate were recorded 5 minutes before and immediately after the procedure .


The duration of the procedure of each group were also analyzed .


Statistically significant differences were detected between group 1 and group 2 in the mean pain score on VAS ( 2.53 1.34 vs 1.63 1.09 , P = 0.002 , Mann-Whitney U test ) , mean postprocedural State Anxiety Inventory pain score ( 39.4 6.5 vs 34.5 5.8 ) , and postprocedural pulse rate ( 79.8 5.5 vs 76.0 7.3 ) ( P < 0.001 for both , t test ) .


Patients who listened to their preferred music experienced less discomfort and lower anxiety at cystoscopy .


Patient age , duration of the procedure , preprocedural STAI-S , and preprocedural pulse rate of each group were comparable .


Listening to preferred music during flexible cystoscopy is an easy way to improves male patients ' comfort and reduce their anxiety .


It could be recommended for male patients .


Postoperative sore throat is one of the most common problems after tonsillectomy .


Antibiotics remove the local flora and reduce inflammation and thus may reduce postoperative pain after tonsillectomy .


To assess the effect of topical sucralfate and clindamycin on local pain reduction after tonsillectomy in children aged 6 to 12 years .


Triple-blind randomized clinical trial of children aged 6 to 12 years with sleep apnea or snoring due to adenotonsillar hypertrophy and chronic airway obstruction or with chronic infections who were candidates for tonsillectomy at Besat Hospital , Hamadan University of Medical Sciences , from May to October 2013 .


Patients were randomly assigned to receive sucralfate mouthwash , clindamycin mouthwash , or placebo ( cellulose ) .


The oral cavity was washed before and immediately after surgery with 10 mL of the prepared solution for 1 minute and then suctioned .


Then , 8 hours after surgery , the patients were asked to keep 10 mL of the prepared mouthwash solution in their mouths for 1 minute 3 times a day for 3 days .


Postoperative sore throat evaluated daily for 5 days using the Faces Pain Scale-Revised .


Of 110 patients enrolled , 101 patients remained for analysis .


Patients in the placebo group had significantly higher mean ( SD ) throat pain scores than did patients in both drug groups on postsurgery days 1 through 4 .


Day 1 scores were 8.00 ( 1.84 ) for placebo and 6.00 ( 1.84 ) for sucralfate and 6.79 ( 1.87 ) for clindamycin ( P = .001 ) .


Pain scores were not significantly different on day 5 .


Acetaminophen use was more common in the placebo group on days 3 and 4 ( 2.97 and 2.44 ) vs the sucralfate group ( 2.24 and 2.15 ) and the clindamycin group ( 2.36 and 2.12 ) ( P = .001 and .02 , respectively ) .


Bleeding on day 1 was more common in the placebo group ( 3 of 34 ) vs none in the drug groups .


Food intolerance on day 1 was less common in patients receiving sucralfate ( 2 of 34 ) than placebo ( 9 of 34 ) or clindamycin ( 11 of 33 ) ( P = .02 ) .


There was no significant difference among the 3 groups in numbers of episodes of nocturnal waking , halitosis , earache , nausea , and vomiting .


This trial indicated that topical sucralfate and clindamycin are safe drugs with no important adverse effects that can significantly reduce posttonsillectomy pain in children and help them return to normal life sooner .


Iranian Registry of Clinical Trials registration number : IRCT201303209014N16 .


Despite all the technological advances in orthodontics , orthodontic treatment still seems to involve some degree of discomfort and/or pain .


Pain control during orthodontic therapy is of great concern to both orthodontists and patients .


However , there has been limited research into controlling such pain .


The purpose of this work was to assess patient-perceived pain following fixed orthodontic treatment and to evaluate the comparative analgesic efficacy of non-steroidal anti-inflammatory drugs for controlling pain .


A total of 45patients about to undergo fixed appliance orthodontic treatment were enrolled in this double-blind prospective study .


Patients were evenly and randomly distributed in a blinded manner to one of three groups as follows : paracetamol/acetaminophen 500mg thrice daily ; placebo in the form of empty capsules ; and etoricoxib 60mg once daily .


Drug administration began 1h before initiating the bonding procedure and archwire placement , and given until the day3 .


The pain perceived was recorded by the patients on a linear and graded Visual Analogue Scale at time intervals of 2h after insertion of the appliance ; 6h thereafter and again at nighttime of the same day of the appointment ; 24h later and on the 2nd day at nighttime ; 48h after the appointment and on day3 at nighttime .


Our results revealed that moderately intense pain is associated with routine orthodontic treatment , and that the amount of pain individuals perceive varies widely .


We observed statistically significant differences in the pain control among the three groups , and that etoricoxib 60mg proved most efficient .


Etoricoxib 60mg is highly efficacious for controlling pain during fixed orthodontic appliance therapy .


The use of drug-eluting stents ( DES ) in patients with non-ST-segment elevation acute coronary syndrome ( NSTE-ACS ) is controversial and not yet endorsed in clinical guidelines .


This was an a priori planned post hoc analysis involving 754 NSTE-ACS patients from the randomised BASKET-PROVE trial ( sirolimus-eluting stent vs. everolimus-eluting stent vs. bare metal stent in large-vessel stenting ) .


The primary endpoint was the combined two-year rate of cardiovascular death or non-fatal myocardial infarction ( MI ) .


Secondary endpoints were each component of the primary endpoint , and clinically indicated target vessel revascularisation ( TVR ) and stent thrombosis .


Compared to patients with BMS , those treated with SES and EES had a strong trend towards lower two-year rates of the primary endpoint ( HR : 0.31 [ CI : 0.11-0 .90 ] , p = 0.03 , and HR : 0.74 [ CI : 0.44-1 .24 ] , p = 0.25 ) , and of TVR ( HR : 0.58 [ CI : 0.29-1 .15 ] , p = 0.12 ) and ( HR : 0.52 [ CI : 0.34-0 .78 ] , p = 0.002 ) .


When the SES and EES groups were combined and compared to BMS , significant reductions in both cardiovascular death/MI and TVR were found .


Compared with BMS , use of DES in NSTE-ACS patients undergoing stent implantation in large vessels was associated with a reduction in both TVR and the combined endpoint consisting of cardiovascular death/MI .


Thus , DES use improves both efficacy and safety .


These findings support the use of DES in NSTE-ACS patients .


Data are limited on the implementation of evidence-based multilevel interventions targeted at blood pressure ( BP ) control in hypertensive blacks who receive care in low-resource primary care practices .


Counseling African Americans to Control Hypertension is a cluster-randomized clinical trial in which 30 community health centers were randomly assigned to the intervention condition ( IC ) or usual care ( UC ) .


Patients at the IC sites received patient education , home BP monitoring , and monthly lifestyle counseling , whereas physicians attended monthly hypertension case rounds and received feedback on their patients ' home BP readings and chart audits .


Patients and physicians at the UC sites received printed patient education material and hypertension treatment guidelines , respectively .


The primary outcome was BP control , and secondary outcomes were mean changes in systolic and diastolic BPs at 12 months , assessed with an automated BP device .


A total of 1059 patients ( mean age , 56 years ; 28 % men , 59 % obese , and 36 % with diabetes mellitus ) were enrolled .


The BP control rate was similar in both groups ( IC = 49.3 % versus UC = 44.5 % ; odds ratio , 1.21 [ 95 % confidence interval , 0.90-1 .63 ] ; P = 0.21 ) .


In prespecified subgroup analyses , the intervention was associated with greater BP control in patients without diabetes mellitus ( IC = 54.0 % versus UC = 44.7 % ; odds ratio , 1.45 [ confidence interval , 1.02-2 .06 ] ) ; and small-sized community health centers ( IC = 51.1 % versus UC = 39.6 % ; odds ratio , 1.45 [ confidence interval , 1.04-2 .45 ] ) .


A practice-based , multicomponent intervention was no better than UC in improving BP control among hypertensive blacks .


Future research on the implementation of behavioral modification strategies for hypertension control in low-resource settings should focus on the development of more efficient and tailored interventions in this high-risk population .


http://www.clinicaltrials.gov .


Unique identifier : NCT00233220 .


The fast development of e-learning and social forums demands us to update our understanding of e-learning and peer learning .


We aimed to investigate if higher , pre-defined levels of e-learning or social interaction in web forums improved students ' learning ability .


One hundred and twenty Danish medical students were randomized to six groups all with 20 students ( eCases level 1 , eCases level 2 , eCases level 2 + , eTextbook level 1 , eTextbook level 2 , and eTextbook level 2 + ) .


All students participated in a pre-test , Group 1 participated in an interactive case-based e-learning program , while Group 2 was presented with textbook material electronically .


The 2 + groups were able to discuss the material between themselves in a web forum .


The subject was head injury and associated treatment and observation guidelines in the emergency room .


Following the e-learning , all students completed a post-test .


Pre - and post-tests both consisted of 25 questions randomly chosen from a pool of 50 different questions .


All students concluded the study with comparable pre-test results .


Students at Level 2 ( in both groups ) improved statistically significant compared to students at level 1 ( p > 0.05 ) .


There was no statistically significant difference between level 2 and level 2 + .


However , level 2 + was associated with statistically significant greater student 's satisfaction than the rest of the students ( p > 0.05 ) .


This study applies a new way of comparing different types of e-learning using a pre-defined level division and the possibility of peer learning .


Our findings show that higher levels of e-learning does in fact provide better results when compared with the same type of e-learning at lower levels .


While social interaction in web forums increase student satisfaction , learning ability does not seem to change .


Both findings are relevant when designing new e-learning materials .


Switch maintenance is an effective strategy in the treatment of advanced Non-Small Cell Lung Cancer ( NSCLC ) .


Pazopanib is an oral , multi-targeted tyrosine kinase inhibitor ( TKI ) .


EORTC 08092 evaluated pazopanib given as maintenance treatment following standard first line platinum-based chemotherapy in patients with advanced NSCLC .


Patients with non-progressive disease after 4-6 cycles of chemotherapy were randomised to receive either pazopanib 800mg/day or matched placebo until progression or unacceptable toxicity .


The primary end-point was overall survival and secondary end-points were progression-free survival ( PFS ) and safety .


A total of 600 patients were planned to be randomised .


The trial was prematurely stopped following an early interim analysis , after 102 patients were randomised to pazopanib ( n = 50 ) or placebo ( n = 52 ) .


Median age was 64years in both arms .


Median overall survival was 17.4 months for pazopanib and 12.3 months for placebo ( adjusted hazard ratio ( HR ) 0.72 [ 95 % confidence interval ( CI ) 0.40-1 .28 ] ; p = 0.257 ) .


Median PFS was 4.3 months versus 3.2 months ( HR 0.67 , [ 95 % CI 0.43-1 .03 ] , p = 0.068 ) .


PFS rates at 4 months were 56 % and 45 % respectively .


The majority of treatment-related adverse events ( AEs ) were grade 1-2 .


Grade 3-4 AEs ( pazopanib versus placebo ) were hypertension ( 38 % versus 8 % ) , neutropenia ( 8 % versus 0 % ) , and elevated SGPT ( 6 % versus 0 % ) .


Of the patients randomised to pazopanib , 22 % withdrew due to a treatment-related AE .


Switch maintenance with pazopanib following platinum-based chemotherapy in advanced NSCLC patients had limited side-effects .


This study was stopped due to lack of efficacy by stringent criteria for PFS at a futility interim analysis .


Conventional food production commonly uses organophosphate ( OP ) pesticides , which can have negative health effects , while organic food is deemed healthier because it is produced without these pesticides .


Studies suggest that organic food consumption may significantly reduce OP pesticide exposure in children who have relatively higher pesticide exposure than adults due to their different diets , body weight , behaviour and less efficient metabolism .


A prospective , randomised , crossover study was conducted to determine if an organic food diet reduces organophosphate exposure in adults .


Thirteen participants were randomly allocated to consume a diet of at least 80 % organic or conventional food for 7 days and then crossed over to the alternate diet .


Urinary levels of six dialkylphosphate metabolites were analysed in first-morning voids collected on day 8 of each phase using GC-MS/MS with detection limits of 0.11-0 .51 g/L .


The mean total DAP results in the organic phase were 89 % lower than in the conventional phase ( M = 0.032 [ SD = 0.038 ] and 0.294 [ SD = 0.435 ] respectively , p = 0.013 ) .


For total dimethyl DAPs there was a 96 % reduction ( M = 0.011 [ SD = 0.023 ] and 0.252 [ SD = 0.403 ] respectively , p = 0.005 ) .


Mean total diethyl DAP levels in the organic phase were half those of the conventional phase ( M = 0.021 [ SD = 0.020 ] and 0.042 [ SD = 0.038 ] respectively ) , yet the wide variability and small sample size meant the difference was not statistically significant .


The consumption of an organic diet for one week significantly reduced OP pesticide exposure in adults .


Larger scale studies in different populations are required to confirm these findings and investigate their clinical relevance .


Postpartum infections are polymicrobial and typically include Ureaplasma , an intracellular microbe that is treated by macrolides such as azithromycin .


The aim of this study was to evaluate the perinatal pharmacokinetics of azithromycin after a single preincision dose before cesarean delivery .


Thirty women who underwent scheduled cesarean delivery were assigned randomly to receive 500 mg of intravenous azithromycin that was initiated 15 , 30 , or 60 minutes before incision and infused over 1 hour .


Serial maternal plasma samples were drawn from the end of infusion up to 8 hours after the infusion .


Samples of amniotic fluid , umbilical cord blood , placenta , myometrium , and adipose tissue were collected intraoperatively .


Breast milk samples were collected 12-48 hours after the infusion in 8 women who were breastfeeding .


Azithromycin was quantified with high performance liquid chromatography separation coupled with tandem mass spectrometry detection .


Plasma pharmacokinetic parameters were estimated with the use of noncompartmental analysis and compartmental modeling and simulations .


The maximum maternal plasma concentration was reached within 1 hour and exceeded the in vitro minimum inhibitory concentration ( MIC50 ) of 250 ng/mL of Ureaplasma spp in all 30 patients .


The concentrations were sustained with a half-life of 6.7 hours .


The median concentration of azithromycin in adipose tissue was 102 ng/g , which was below the MIC50 .


The median concentration in myometrium was 402 ng/g , which exceeded the MIC50 .


Azithromycin was detectable in both the umbilical cord plasma and amniotic fluid after the single preoperative dose .


Azithromycin concentrations in breast milk were high and were sustained up to 48 hours after the single dose .


Simulations demonstrated accumulation in breast milk after multiple doses .


A single dose of azithromycin achieves effective plasma and tissue concentrations and is transported rapidly across the placenta .


The tissue concentrations that are achieved in the myometrium exceed the MIC50 for Ureaplasma spp .


To determine the immunologic effects of oropharyngeal colostrum administration in extremely premature infants .


We conducted a double-blind , randomized , placebo-controlled trial involving 48 preterm infants born before 28 weeks ' gestation .


Subjects received 0.2 mL of their mother 's colostrum or sterile water via oropharyngeal route every 3 hours for 3 days beginning at 48 to 96 hours of life .


To measure concentrations of secretory immunoglobulin A , lactoferrin , and several immune substances , urine and saliva were obtained during the first 24 hours of life and at 8 and 15 days .


Clinical data during hospitalization were collected .


Urinary levels of secretory immunoglobulin A at 1 week ( 71.4 vs 26.5 ng/g creatinine , P = .04 ) and 2 weeks ( 233.8 vs 48.3 ng/g creatinine , P = .006 ) , and lactoferrin at 1 week ( 3.5 vs 0.9 g/g creatinine , P = .01 ) were significantly higher in colostrum group .


Urine interleukin-1 level was significantly lower in colostrum group at 2 weeks ( 55.3 vs 91.8 g/g creatinine , P = .01 ) .


Salivary transforming growth factor-1 ( 39.2 vs 69.7 g/mL , P = .03 ) and interleukin-8 ( 1.2 vs 4.9 ng/mL , P = .04 ) were significantly lower at 2 weeks in colostrum group .


A significant reduction in the incidence of clinical sepsis was noted in colostrum group ( 50 % vs 92 % , P = .003 ) .


This study suggests that oropharyngeal administration of colostrum may decrease clinical sepsis , inhibit secretion of pro-inflammatory cytokines , and increase levels of circulating immune-protective factors in extremely premature infants .


Larger studies to confirm these findings are warranted .


Aortic-root dissection is the leading cause of death in Marfan 's syndrome .


Studies suggest that with regard to slowing aortic-root enlargement , losartan may be more effective than beta-blockers , the current standard therapy in most centers .


We conducted a randomized trial comparing losartan with atenolol in children and young adults with Marfan 's syndrome .


The primary outcome was the rate of aortic-root enlargement , expressed as the change in the maximum aortic-root-diameter z score indexed to body-surface area ( hereafter , aortic-root z score ) over a 3-year period .


Secondary outcomes included the rate of change in the absolute diameter of the aortic root ; the rate of change in aortic regurgitation ; the time to aortic dissection , aortic-root surgery , or death ; somatic growth ; and the incidence of adverse events .


From January 2007 through February 2011 , a total of 21 clinical centers enrolled 608 participants , 6 months to 25 years of age ( mean [ SD ] age , 11.56.5 years in the atenolol group and 11.06.2 years in the losartan group ) , who had an aortic-root z score greater than 3.0 .


The baseline-adjusted rate of change in the mean ( SE ) aortic-root z score did not differ significantly between the atenolol group and the losartan group ( -0.1390.013 and -0.1070.013 standard-deviation units per year , respectively ; P = 0.08 ) .


Both slopes were significantly less than zero , indicating a decrease in the aortic-root diameter relative to body-surface area with either treatment .


The 3-year rates of aortic-root surgery , aortic dissection , death , and a composite of these events did not differ significantly between the two treatment groups .


Among children and young adults with Marfan 's syndrome who were randomly assigned to losartan or atenolol , we found no significant difference in the rate of aortic-root dilatation between the two treatment groups over a 3-year period .


( Funded by the National Heart , Lung , and Blood Institute and others ; ClinicalTrials.gov number , NCT00429364 . )


To investigate the efficacy and safety of aerobic training ( AT ) in patients with cancer with medically stable heart failure ( HF ) .


A retrospective analysis of 90 patients with cancer who have HF and who were randomly assigned to AT ( n = 47 ) or guideline-based usual care ( UC ; n = 43 ) was performed .


AT consisted of three supervised sessions per week at 20 to 45 minutes per session at 60 % to 70 % of heart rate reserve for 12 weeks followed by home-based sessions for 4 to 12 months .


The primary end point was all-cause mortality and hospitalization .


Secondary end points were other clinical events , safety , and change in exercise capacity ( VO ( 2peak ) ) and health-related quality of life ( HRQOL ) .


Median follow-up was 35 months .


In intention-to-treat ( ITT ) analyses , all-cause mortality or hospitalization at 2 years was 74 % in the AT group compared with 67 % in the UC group ( adjusted hazard ratio [ HR ] , 1.11 ; 95 % CI , 0.69 to 1.77 ; P = .676 ) .


The incidence of cardiovascular mortality or cardiovascular hospitalization was significantly higher in the AT group compared with the UC group ( 41 % v 67 % ; adjusted HR , 1.94 ; 95 % CI , 1.12 to 3.16 ; P = .017 ) .


There were no differences in any VO ( 2peak ) or HRQOL end points .


In post hoc analyses based on adherence to AT , all-cause mortality and hospitalization was 66 % in adherent patients ( 90 minutes per week ) compared with 84 % in nonadherent patients ( < 90 minutes per week ) .


In ITT analyses , AT did not improve clinical outcomes in patients with cancer who had HF .


Post hoc analyses suggested that patients not capable of adhering to the planned AT prescription may be at increased risk of clinical events .


To determine whether droxidopa , an oral norepinephrine precursor , improves symptomatic neurogenic orthostatic hypotension ( nOH ) .


Patients with symptomatic nOH due to Parkinson disease , multiple system atrophy , pure autonomic failure , or nondiabetic autonomic neuropathy underwent open-label droxidopa dose optimization ( 100-600 mg 3 times daily ) , followed , in responders , by 7-day washout and then a 7-day double-blind trial of droxidopa vs placebo .


Outcome measures included patient self-ratings on the Orthostatic Hypotension Questionnaire ( OHQ ) , a validated , nOH-specific tool that assesses symptom severity and symptom impact on daily activities .


From randomization to endpoint ( n = 162 ) , improvement in mean OHQ composite score favored droxidopa over placebo by 0.90 units ( p = 0.003 ) .


Improvement in OHQ symptom subscore favored droxidopa by 0.73 units ( p = 0.010 ) , with maximum change in `` dizziness/lightheadedness . ''


Improvement in symptom-impact subscore favored droxidopa by 1.06 units ( p = 0.003 ) , with maximum change for `` standing a long time . ''


Mean standing systolic blood pressure ( BP ) increased by 11.2 vs 3.9 mm Hg ( p < 0.001 ) , and mean supine systolic BP by 7.6 vs 0.8 mm Hg ( p < 0.001 ) .


At endpoint , supine systolic BP > 180 mm Hg was observed in 4.9 % of droxidopa and 2.5 % of placebo recipients .


Adverse events reported in 3 % of double-blind droxidopa recipients were headache ( 7.4 % ) and dizziness ( 3.7 % ) .


No patients discontinued double-blind treatment because of adverse events .


In patients with symptomatic nOH , droxidopa improved symptoms and symptom impact on daily activities , with an associated increase in standing systolic BP , and was generally well tolerated .


This study provides Class I evidence that in patients with symptomatic nOH who respond to open-label droxidopa , droxidopa improves subjective and objective manifestation of nOH at 7 days .


Midazolam comedication with morphine is a routine practice in pre and postoperative patients but has not been evaluated in prehospital setting .


We aimed to evaluate the comedication effect of midazolam in the prehospital traumatic adults .


A prehospital prospective randomized double-blind placebo-controlled trial of intravenous morphine 0.10 mg/kg and midazolam 0.04 mg/kg vs morphine 0.10 mg/kg and placebo .


Pain assessment was done using a validated numeric rating scale ( NRS ) .


The primary end point was to achieve an efficient analgesic effect ( NRS3 ) 20 minutes after the baseline .


The secondary end points were treatment safety , total morphine dose required until obtaining NRS3 , and efficient analgesic effect 30 minutes after the baseline .


Ninety-one patients were randomized into midazolam ( n = 41 ) and placebo ( n = 50 ) groups .


No significant difference in proportion of patients with a pain score3 was observed between midazolam ( 43.6 % ) and placebo ( 45.7 % ) after 20 minutes ( P = .849 ) .


Secondary end points were similar in regard with proportion of patients with a pain score3 at T30 , the side effects and adverse events except for drowsiness in midazolam vs placebo , 43.6 % vs 6.5 % ( P < .001 ) .


No significant difference in total morphine dose was observed , that is , midazolam ( 14.09 mg6 .64 ) vs placebo ( 15.53 mg6 .27 ) ( P = .315 ) .


According to our study , midazolam does not enhance pain control as an adjunctive to morphine regimen in the management of trauma-induced pain in prehospital setting .


However , such midazolam use seems to be associated with an increase in drowsiness .


Recent initiatives to target the personal , social and clinical needs of people with long-term health conditions have had limited impact within primary care .


Evidence of the importance of social networks to support people with long-term conditions points to the need for self-management approaches which align personal circumstances with valued activities .


The Patient-Led Assessment for Network Support ( PLANS ) intervention is a needs-led assessment for patients to prioritise their health and social needs and provide access to local community services and activities .


Exploring the work and practices of patients and telephone workers are important for understanding and evaluating the workability and implementation of new interventions .


Qualitative methods ( interviews , focus group , observations ) were used to explore the experience of PLANS from the perspectives of participants and the telephone support workers who delivered it ( as part of an RCT ) and the reasons why the intervention worked or not .


Normalisation Process Theory ( NPT ) was used as a sensitising tool to evaluate : the relevance of PLANS to patients ( coherence ) ; the processes of engagement ( cognitive participation ) ; the work done for PLANS to happen ( collective action ) ; the perceived benefits and costs of PLANS ( reflexive monitoring ) .


20 patients in the intervention arm of a clinical trial were interviewed and their telephone support calls were recorded and a focus group with 3 telephone support workers was conducted .


Analysis of the interviews , support calls and focus group identified three themes in relation to the delivery and experience of PLANS .


These are : formulation of ` health ' in the context of everyday life ; trajectories and tipping points : disrupting everyday routines ; precarious trust in networks .


The relevance of these themes are considered using NPT constructs in terms of the work that is entailed in engaging with PLANS , taking action , and who is implicated this process .


PLANS gives scope to align long-term condition management to everyday life priorities and valued aspects of life .


This approach can improve engagement with health-relevant practices by situating them within everyday contexts .


This has potential to increase utilisation of local resources with potential cost-saving benefits for the NHS .


ISRCTN45433299 .


To evaluate the effect of acupuncture on hot flushes and other menopause-related symptoms used in an integrated system , including such therapeutic techniques as diet therapy and Tuina self-massage .


Randomized trial .


Outpatient center .


One hundred women in spontaneous menopause with at least three episodes of hot flushes daily were randomly allocated to two treatment groups ( 50 per group ) : Women in group A were given diet , self-massage training , and treatment with acupuncture , and women in group B ( the control group ) were given the same diet and self-massage training , but treatment with acupuncture started 6 weeks after they were enrolled into the study .


Acupuncture treatments were scheduled twice weekly for 6 consecutive weeks .


Mean change in frequency and/or intensity in menopause-related symptoms were estimated by questionnaire after treatment at week 4 .


Treatment with acupuncture significantly reduced the occurrence of hot flushes and sudden sweating ( p < .001 ) .


Other symptoms ( sleep disorders , tightness in the chest , irritability , bone pain , feeling depressed ) significantly improved .


Acupuncture in an integrated system that includes therapeutic techniques such as diet therapy and Tuina self-massage can be used to treat hot flushes and selected symptoms in postmenopausal women .


Although social anxiety disorder is a common and sometimes disabling condition , there are no approved treatments that can be used on an as-needed basis .


The authors examined the acute use of PH94B , an intranasally administered neurosteroidal aerosol , for the acute management of the symptoms of social anxiety disorder .


The authors conducted a phase 2 , multicenter , randomized , double-blind , placebo-controlled , single-dose study of PH94B .


Ninety-one women 19-60 years of age with generalized social anxiety disorder received placebo intranasal spray ( single-blind ) 15 minutes before laboratory-simulated public speaking and social interaction challenges .


Patients who experienced significant distress during at least one challenge returned 1 week later to receive either intranasal PH94B or placebo aerosol spray ( double-blind ) before repeat challenges .


Patients who received PH94B during the second set of challenges had a significantly greater decrease in mean Subjective Units of Distress scores during the public speaking and social interaction challenges compared with the first set of challenges , than did patients who received placebo for both sets of challenges .


A significantly greater proportion of the PH94B group were much or very much improved from the first to the second sets of challenges compared with the placebo group ( 75 % and 37 % , respectively ) .


The side effects of PH94B were benign .


PH94B may be a novel , effective , and well-tolerated acute treatment for performance and social anxiety in women with social anxiety disorder .


Autologous chondrocyte implantation ( ACI ) aims to restore hyaline cartilage .


Traditionally , ACI rehabilitation is prescribed in a concurrent ( CON ) format .


However , it is well known from studies in asymptomatic populations that CON training produces an interference effect that can attenuate strength gains .


Strength is integral to joint function , so adopting a nonconcurrent ( N-CON ) approach to ACI rehabilitation might improve outcomes .


To assess changes in function and neuromuscular performance during 48 wk of CON and N-CON physical rehabilitation after ACI to the knee .


Orthopedic Hospital NHS Foundation Trust .


Randomized control , pilot study .


11 patients ( 9 male , 2 female ; age 32.3 6.6 y ; body mass 79.3 10.4 kg ; time from injury to surgery 7.1 4.9 mo [ mean SD ] ) randomly allocated to N-CON : CON ( 2:1 ) .


Standardized CON and N-CON physiotherapy that involved separation of strength and cardiovascular-endurance conditioning .


Function in the single-leg-hop test , patient-reported outcomes ( Knee injury and Osteoarthritis Outcome Score [ KOOS ] , International Knee Documentation Committee subjective questionnaire [ IKDC ] ) , and neuromuscular outcomes of peak force ( PF ) , rate of force development ( RFD ) , electromechanical delay ( EMD ) , and sensorimotor performance ( force error [ FE ] ) of the knee extensors and flexors of the injured and noninjured legs , measured presurgery and at 6 , 12 , 24 , and 48 wk postsurgery .


Factorial ANOVAs with repeated measures of group by leg and by test occasion revealed significantly superior improvements for KOOS , IKDC , PF , EMD , and FE associated with N-CON vs. CON rehabilitation ( F ( 1.5,13.4 GG ) = 3.7-4 .7 , P < .05 ) .


These results confirm increased peak effectiveness of N-CON rehabilitation ( ~ 4.5-13 .3 % better than CON over 48 wk of rehabilitation ) .


N-CON and CON showed similar patterns of improvement for single-leg-hop test and RFD .


Nonconcurrent strength and cardiovascular-endurance conditioning during 48 wk of rehabilitation after ACI surgery elicited significantly greater improvements to functional and neuromuscular outcomes than did contemporary concurrent rehabilitation .


Study objective To assess the efficacy of outpatient misoprostol administration versus inpatient misoprostol administration for the treatment of first trimester incomplete miscarriage .


A prospective randomised controlled trial was conducted at a tertiary hospital from May 2012 to April 2013 .


A total of 154 patients with first trimester incomplete miscarriage were randomised to receive misoprostol either as outpatient or inpatient .


Intra-vaginal misoprostol 800 mcg was administered eight hourly to a maximum of three doses .


Complete evacuation is achieved when the cervical os was closed on vaginal examination or ultrasound showed no more retained products of conception evidenced by endometrial thickness of less than 15 mm .


Treatment failure was defined as failure in achieving complete evacuation on day seven hence surgical evacuation is offered .


Outpatient administration of misoprostol was as effective as inpatient treatment with success rate of 89.2 and 85.7 % ( p = 0.520 ) .


The side effects were not significantly different between the two groups .


Side effects that occurred were minor and only required symptomatic treatment .


Duration of bleeding was 6.0 days in both groups ( p = 0.317 ) .


Mean reduction in haemoglobin was lesser in the outpatient group ( 0.4 g/dl ) as compared to in the inpatient group ( 0.6 g/dl ) which was statistically significant ( p = 0.048 ) .


Medical evacuation using intra-vaginal misoprostol 800 mcg eight hourly for a maximum of three doses in an outpatient setting is as effective as in inpatient setting with tolerable side effects .


The authors examine the pattern of direction errors made during the manipulation of a physical simulation of an underground coal mine bolting machine to assess the directional control-response compatibility relationships associated with the device and to compare these results to data obtained from a virtual simulation of a generic device .


Directional errors during the manual control of underground coal roof bolting equipment are associated with serious injuries .


Directional control-response relationships have previously been examined using a virtual simulation of a generic device ; however , the applicability of these results to a specific physical device may be questioned .


Forty-eight participants randomly assigned to different directional control-response relationships manipulated horizontal or vertical control levers to move a simulated bolter arm in three directions ( elevation , slew , and sump ) as well as to cause a light to become illuminated and raise or lower a stabilizing jack .


Directional errors were recorded during the completion of 240 trials by each participant


Directional error rates are increased when the control and response are in opposite directions or if the direction of the control and response are perpendicular.The pattern of direction error rates was consistent with experiments obtained from a generic device in a virtual environment .


Error rates are increased by incompatible directional control-response relationships .


Ensuring that the design of equipment controls maintains compatible directional control-response relationships has potential to reduce the errors made in high-risk situations , such as underground coal mining .


To evaluate the impact of 10-14-day intravenous administration of meldonium as part of combination therapy in patients with chronic heart failure in the early post-infarction period on the recovery period , structural and functional parameters , and heart rate variability ( HRV ) .


The investigation enrolled 60 patients ( men and women ) aged 45 to 75 years at weeks 3-4 after post-myocardial infarction with symptoms of Functional Class II-III heart failure .


All the patients underwent 24-hour electrochocardiography monitoring , cardiac echocardiography , and HRV study .


After dividing the patients into 2 groups , Group 1 ( a study group ) ( n = 30 ) was given intravenous meldonium ( idrinol ) 1000 mg/day in addition to the basic therapy of coronary heart disease .


The patients in the study and control ( Group 2 ; n = 30 ) groups were at baseline matched for age , gender , disease severity , and basic therapy pattern .


Following 10-14 days of treatment , both groups showed clinical improvement and the favorable changes in cardiac structural and functional parameters and HRV values , which were more pronounced in the patients receiving meldonium .


The patients with CHF using meldonium as part of combination therapy in the early post-infarction period were observed to have clinical improvement , a significant reduction in the rate of angina attacks and in the need for nitrates , a decrease in the number of arrhythmic and ischemic episodes , and favorable changes in cardiac structural and functional parameters and HRV values .


This article illustrates the use of mixed methods in the development and evaluation of the Positive Online Weight Reduction ( POWeR ) programme , an e-health intervention designed to support sustainable weight loss .


The studies outlined also explore how human support might enhance intervention usage and weight loss .


Mixed methods were used to develop and evaluate POWeR .


In the development phase , we drew on both quantitative and qualitative findings to plan and gain feedback on the intervention .


Next , a feasibility trial , with nested qualitative study , explored what level of human support might lead to the most sustainable weight loss .


Finally , a large community-based trial of POWeR , with nested qualitative study , explored whether the addition of brief telephone coaching enhances usage .


Findings suggest that POWeR is acceptable and potentially effective .


Providing human support enhanced usage in our trials , but was not unproblematic .


Interestingly , there were some indications that more basic ( brief ) human support may produce more sustainable weight loss outcomes than more regular support .


Qualitative interviews suggested that more regular support might foster reliance , meaning patients can not sustain their weight losses when support ends .


Qualitative findings in the community trial also suggested explanations for why many people may not take up the opportunity for human support .


Integrating findings from both our qualitative and quantitative studies provided far richer insights than would have been gained using only a single method of inquiry .


Further research should investigate the optimum delivery of human support needed to maximize sustainable weight loss in online interventions .


Statement of contribution What is already known on this subject ?


There is evidence that human support may increase the effectiveness of e-health interventions .


It is unclear what level of human support might be optimal or how human support improves effectiveness .


Triangulation of quantitative and qualitative methods can be used to inform the design and implementation of interventions What does this study add ?


This paper demonstrates the value of a mixed methods approach when developing and evaluating an intervention .


Qualitative methods provided complementary insights into the optimal level of human support .


Brief human support is valued by some and may enhance usage and outcomes of an e-health intervention for weight loss .


This study assessed whether the Venner-PneuX endotracheal tube ( ET ) system , which has sub-glottic suction as well as irrigation ports and continuous cuff-pressure monitoring , is associated with a reduction in ventilator-associated pneumonia ( VAP ) when compared with the standard ET in high-risk patients undergoing cardiac surgery .


This was a single-institution , prospective , randomized control trial .


Patients were categorized as either Group A ( Venner-PneuX ET tube , n = 120 ) or Group B ( Standard ET tube , n = 120 ) .


Inclusion criteria included patients over the age of 70 years and/or impaired left ventricular function ( LVEF < 50 % ) undergoing cardiac surgery .


Patients were monitored for VAP for up to 48 h post extubation and the diagnosis of VAP was according to the centres for disease control definition .


There were no significant differences in the patients ' demographics .


The mean ( SD ) ages for the two groups were 72.4 ( 8.2 ) and 72.1 ( 7.4 ) years ( P = 0.6 ) , respectively .


The mean EuroSCORE was 6.39 ( 2.2 ) for Group A and 6.48 ( 2.6 ) for Group B ( P = 0.9 ) .


The median intubation times were 14.7 ( 7.3 , 2927.2 ) h and 13 ( 2.5 , 528.7 ) h , respectively .


VAP incidence was significantly lower in the Venner-PneuX ET group , being 10.8 % when compared with 21 % in the standard ET group ( P = 0.03 ) .


There was no significant difference between the two groups in terms of intensive care unit stay ( P = 0.2 ) and in-hospital mortality ( P = 0.2 ) .


A binary logistic regression analysis ( type of ET tube , age , LVEF , history of lung disease , smoking history , surgical procedure , EuroSCORE , cardiopulmonary bypass time , blood transfusion , intubation duration among others ) confirmed that the Venner-PneuX ET tube was associated with significant VAP reduction ( Odds ratio 0.45 , P = 0.03 ) .


The Venner-PneuX VAP prevention system is associated with a significant reduction in VAP .


This can potentially lead to significant cost reductions and should be implemented as part of the VAP reduction bundle .


Treatment of respiratory distress syndrome in premature infants with continuous positive airway pressure ( CPAP ) preserves surfactant and keeps the lung open but is insufficient in severe surfactant deficiency .


Traditional surfactant administration is related to short periods of positive pressure ventilation and implies the risk of lung injury .


CPAP with surfactant but without any positive pressure ventilation may work synergistically .


This randomized trial investigated a less invasive surfactant application protocol ( LISA ) .


To test the hypothesis that LISA increases survival without bronchopulmonary dysplasia ( BPD ) at 36 weeks ' gestational age in extremely preterm infants .


The Nonintubated Surfactant Application trial was a multicenter , randomized , clinical , parallel-group study conducted between April 15 , 2009 , and March 25 , 2012 , in 13 level III neonatal intensive care units in Germany .


The final follow-up date was June 21 , 2012 .


Participants included 211 of 558 eligible ( 37.8 % ) spontaneously breathing preterm infants born between 23.0 and 26.8 weeks ' gestational age with signs of respiratory distress syndrome .


In an intention-to-treat design , infants were randomly assigned to receive surfactant either via a thin endotracheal catheter during CPAP-assisted spontaneous breathing ( intervention group ) or after conventional endotracheal intubation during mechanical ventilation ( control group ) .


Analysis was conducted from September 6 , 2012 , to June 20 , 2013 .


LISA via a thin catheter .


Survival without BPD at 36 weeks ' gestational age .


Of 211 infants who were randomized , 104 were randomized to the control group and 107 to the LISA group .


Of the infants who received LISA , 72 ( 67.3 % ) survived without BPD compared with 61 ( 58.7 % ) of those in the control group .


The reduction in absolute risk was 8.6 % ( 95 % CI , -5.0 % to 21.9 % ; P = .20 ) .


Intervention group infants were less frequently intubated ( 80 infants [ 74.8 % ] vs 103 [ 99.0 % ] ; P < .001 ) and required fewer days of mechanical ventilation .


Significant reductions were seen in pneumothorax ( 5 of 105 intervention group infants [ 4.8 % ] vs 13 of 103 12.6 % ] ; P = .04 ) and severe intraventricular hemorrhage ( 11 infants [ 10.3 % ] vs 23 [ 22.1 % ] ; P = .02 ) , and the combined survival without severe adverse events was increased in the intervention group ( 54 infants [ 50.5 % ] vs 37 [ 35.6 % ] ; P = .02 ; absolute risk reduction , 14.9 ; 95 % CI , 1.4 to 28.2 ) .


LISA did not increase survival without BPD but was associated with increased survival without major complications .


Because major complications are related to lifelong disabilities , LISA may be a promising therapy for extremely preterm infants .


isrctn.org Identifier : ISRCTN64011614 .


Alcohol misuse in England costs around 7.3 billion ( US$ 12.2 billion ) annually from lost productivity and absenteeism .


Delivering brief alcohol interventions to employees as part of a health check may be acceptable , particularly with online delivery which can provide privacy for this stigmatised behaviour .


Research to support this approach is limited and methodologically weak .


The aim was to determine the effectiveness of online screening and personalised feedback on alcohol consumption , delivered in a workplace as part of a health check .


This two-group online individually randomised controlled trial recruited employees from a UK-based private sector organisation ( approx .


100,000 employees ) .


3,375 employees completed the online health check in the three week recruitment period .


Of these , 1,330 ( 39 % ) scored five or more on the AUDIT-C ( indicating alcohol misuse ) and were randomised to receive personalised feedback on their alcohol intake , alongside feedback on other health behaviours ( n = 659 ) , or to receive feedback on all health behaviours except alcohol intake ( n = 671 ) .


Participants were mostly male ( 75 % ) , with a median age of 48 years and half were in managerial positions ( 55 % ) .


Median Body Mass Index was 26 , 12 % were smokers , median time undertaking moderate/vigorous physical activity a week was 173 minutes and median fruit and vegetable consumption was three portions a day .


Eighty percent ( n = 1,066 ) of participants completed follow-up questionnaires at three months .


An intention to treat analysis found no difference between experimental groups for past week drinking ( primary outcome ) ( 5.6 % increase associated with the intervention ( 95 % CI -4.7 % to 16.9 % ; p = .30 ) ) , AUDIT ( measure of alcohol-related harm ) and health utility ( EQ-5D ) .


There was no evidence to support the use of personalised feedback within an online health check for reducing alcohol consumption among employees in this organisation .


Further research is needed on how to engage a larger proportion of employees in screening .


International Standard Randomised Controlled Trial Number Register ISRCTN50658915 .


The purposes of this study were to compare the oxygen cost , metabolic parameters and temporalspatial variables between barefoot and shod running in trained mid-forefoot runners .


Experienced runners ( N. = 21 ; 3010.9 years ; 16 men ) performed two separate 20 minute treadmill running bouts at ~ 77 % of estimated maximal heart rate .


Rate of oxygen consumption ( VO2 ) , energy cost , fuel use and heart rate ( HR ) were collected continuously using a portable gas analyzer .


Three-dimensional motion capture was used to measure temporalspatial parameters .


Participants ran at a mean self-selected speed of 3.10.3 m/s for both conditions , at intensities corresponding to mean HR values of 146 bpm ( shod ) and 144 bpm ( barefoot ) .


Steady State VO2 was not different between the shod and barefoot conditions ( 39.4 4.7 mL/kg * min vs. 405.2 mL/kg * min , respectively ) .


The total energy expended in the shod and barefoot conditions was 974134 kJ and 979142 kJ .


The average non-protein respiratory exchange ratios , proportions and amount of fat and carbohydrate used were not different between conditions .


Cadence was 2.5 % higher and center of gravity vertical displacement was 0.5 cm less for the barefoot condition ( P < 0.05 ) .


In trained mid-forefoot runners experienced with barefoot running , there are not significant metabolic differences between shod and barefoot running conditions .


Barefoot running increases cadence and decreases foot contact time and vertical displacement .


Experienced participants were likely able to titrate kinematics to standardize energy output and fuel use for a given running distance and speed irrespective of shoe wear .


Clinical trials yielded conflicting data about the benefit of adding systemic corticosteroids for treatment of community-acquired pneumonia .


We assessed whether short-term corticosteroid treatment reduces time to clinical stability in patients admitted to hospital for community-acquired pneumonia .


In this double-blind , multicentre , randomised , placebo-controlled trial , we recruited patients aged 18 years or older with community-acquired pneumonia from seven tertiary care hospitals in Switzerland within 24 h of presentation .


Patients were randomly assigned ( 1:1 ratio ) to receive either prednisone 50 mg daily for 7 days or placebo .


The computer-generated randomisation was done with variable block sizes of four to six and stratified by study centre .


The primary endpoint was time to clinical stability defined as time ( days ) until stable vital signs for at least 24 h , and analysed by intention to treat .


This trial is registered with ClinicalTrials.gov , number NCT00973154 .


From Dec 1 , 2009 , to May 21 , 2014 , of 2911 patients assessed for eligibility , 785 patients were randomly assigned to either the prednisone group ( n = 392 ) or the placebo group ( n = 393 ) .


Median time to clinical stability was shorter in the prednisone group ( 30 days , IQR 25-34 ) than in the placebo group ( 44 days , 40-50 ; hazard ratio [ HR ] 133 , 95 % CI 115-150 , p < 00001 ) .


Pneumonia-associated complications until day 30 did not differ between groups ( 11 [ 3 % ] in the prednisone group and 22 [ 6 % ] in the placebo group ; odds ratio [ OR ] 049 [ 95 % CI 023-102 ] ; p = 0056 ) .


The prednisone group had a higher incidence of in-hospital hyperglycaemia needing insulin treatment ( 76 [ 19 % ] vs 43 [ 11 % ] ; OR 196 , 95 % CI 131-293 , p = 00010 ) .


Other adverse events compatible with corticosteroid use were rare and similar in both groups .


Prednisone treatment for 7 days in patients with community-acquired pneumonia admitted to hospital shortens time to clinical stability without an increase in complications .


This finding is relevant from a patient perspective and an important determinant of hospital costs and efficiency .


Swiss National Science Foundation , Viollier AG , Nora van Meeuwen Haefliger Stiftung , Julia und Gottfried Bangerter-Rhyner Stiftung .


The purpose of this study was to investigate the safety and efficacy of two novel light sources for large area and full body application , providing polychromatic , non-thermal photobiomodulation ( PBM ) for improving skin feeling and appearance .


For non-thermal photorejuvenation , laser and LED light sources have been demonstrated to be safe and effective .


However , lasers and LEDs may offer some disadvantages because of dot-shaped ( punctiform ) emission characteristics and their narrow spectral bandwidths .


Because the action spectra for tissue regeneration and repair consist of more than one wavelength , we investigated if it is favorable to apply a polychromatic spectrum covering a broader spectral region for skin rejuvenation and repair .


A total of 136 volunteers participated in this prospective , randomized , and controlled study .


Of these volunteers , 113 subjects randomly assigned into four treatment groups were treated twice a week with either 611-650 or 570-850 nm polychromatic light ( normalized to 9 J/cm ( 2 ) in the range of 611-650 nm ) and were compared with controls ( n = 23 ) .


Irradiances and treatment durations varied in all treatment groups .


The data collected at baseline and after 30 sessions included blinded evaluations of clinical photography , ultrasonographic collagen density measurements , computerized digital profilometry , and an assessment of patient satisfaction .


The treated subjects experienced significantly improved skin complexion and skin feeling , profilometrically assessed skin roughness , and ultrasonographically measured collagen density .


The blinded clinical evaluation of photographs confirmed significant improvement in the intervention groups compared with the control .


Broadband polychromatic PBM showed no advantage over the red-light-only spectrum .


However , both novel light sources that have not been previously used for PBM have demonstrated efficacy and safety for skin rejuvenation and intradermal collagen increase when compared with controls .


Colon cancers deficient in mismatch repair ( MMR ) may exhibit diminished expression of the DNA repair gene , MRE11 , as a consequence of contraction of a T11 mononucleotide tract .


This study investigated MRE11 status and its association with prognosis , survival and drug response in patients with stage III colon cancer .


Cancer and Leukemia Group B 89803 ( Alliance ) randomly assigned 1,264 patients with stage III colon cancer to postoperative weekly adjuvant bolus 5-fluorouracil/leucovorin ( FU/LV ) or irinotecan + FU/LV ( IFL ) , with 8 year follow-up .


Tumors from these patients were analyzed to determine stability of a T11 tract in the MRE11 gene .


The primary endpoint was overall survival ( OS ) , and a secondary endpoint was disease-free survival ( DFS ) .


Non-proportional hazards were addressed using time-dependent covariates in Cox analyses .


Of 625 tumor cases examined , 70 ( 11.2 % ) exhibited contraction at the T11 tract in one or both MRE11 alleles and were thus predicted to be deficient in MRE11 ( dMRE11 ) .


In pooled treatment analyses , dMRE11 patients showed initially reduced DFS and OS but improved long-term DFS and OS compared with patients with an intact MRE11 T11 tract .


In the subgroup of dMRE11 patients treated with IFL , an unexplained early increase in mortality but better long-term DFS than IFL-treated pMRE11 patients was observed .


Analysis of this relatively small number of patients and events showed that the dMRE11 marker predicts better prognosis independent of treatment in the long-term .


In subgroup analyses , dMRE11 patients treated with irinotecan exhibited unexplained short-term mortality .


MRE11 status is readily assayed and may therefore prove to be a useful prognostic marker , provided that the results reported here for a relatively small number of patients can be generalized in independent analyses of larger numbers of samples .


ClinicalTrials.gov NCT00003835 .


The purpose of this study was to investigate the survival effects of inferior vena cava filters in patients with venous thromboembolism ( VTE ) who had a significant bleeding risk .


The effectiveness of inferior vena cava filter use among patients with acute symptomatic VTE and known significant bleeding risk remains unclear .


In this prospective cohort study of patients with acute VTE identified from the RIETE ( Computerized Registry of Patients With Venous Thromboembolism ) , we assessed the association between inferior vena cava filter insertion for known significant bleeding risk and the outcomes of all-cause mortality , pulmonary embolism ( PE ) - related mortality , and VTE rates through 30 days after the initiation of VTE treatment .


Propensity score matching was used to adjust for the likelihood of receiving a filter .


Of the 40,142 eligible patients who had acute symptomatic VTE , 371 underwent filter placement because of known significant bleeding risk .


A total of 344 patients treated with a filter were matched with 344 patients treated without a filter .


Propensity score-matched pairs showed a nonsignificant trend toward lower risk of all-cause death for filter insertion compared with no insertion ( 6.6 % vs. 10.2 % ; p = 0.12 ) .


The risk-adjusted PE-related mortality rate was lower for filter insertion than no insertion ( 1.7 % vs. 4.9 % ; p = 0.03 ) .


Risk-adjusted recurrent VTE rates were higher for filter insertion than for no insertion ( 6.1 % vs. 0.6 % ; p < 0.001 ) .


In patients presenting with VTE and with a significant bleeding risk , inferior vena cava filter insertion compared with anticoagulant therapy was associated with a lower risk of PE-related death and a higher risk of recurrent VTE .


However , study design limitations do not imply a causal relationship between filter insertion and outcome .


A model for predicting cardiovascular disease in Asian populations is limited .


In total , 57 393 consecutive asymptomatic Korean individuals aged 30 to 80 years without a prior history of cardiovascular disease who underwent a general health examination were enrolled .


Subjects were randomly classified into the train ( n = 45 914 ) and validation ( n = 11 479 ) cohorts .


Thirty-one possible risk factors were assessed .


The cardiovascular event was a composite of cardiovascular death , myocardial infarction , and stroke .


In the train cohort , the C-index ( 95 % confidence interval ) and Akaike Information Criterion were used to develop the best-fitting prediction model .


In the validation cohort , the predicted versus the observed cardiovascular event rates were compared by the C-index and Nam and D'Agostino ( 2 ) statistics .


During a median follow-up period of 3.1 ( interquartile range , 1.9-4 .3 ) years , 458 subjects had 474 cardiovascular events .


In the train cohort , the best-fitting model consisted of age , diabetes mellitus , hypertension , current smoking , family history of coronary heart disease , white blood cell , creatinine , glycohemoglobin , atrial fibrillation , blood pressure , and cholesterol ( C-index = 0.757 [ 0.726-0 .788 ] and Akaike Information Criterion = 7207 ) .


When this model was tested in the validation cohort , it performed well in terms of discrimination and calibration abilities ( C-index = 0.760 [ 0.693-0 .828 ] and Nam and D'Agostino ( 2 ) statistic = 0.001 for 3 years ; C-index = 0.782 [ 0.719-0 .846 ] and Nam and D'Agostino ( 2 ) statistic = 1.037 for 5 years ) .


A risk model based on traditional clinical and biomarkers has a feasible model performance in predicting cardiovascular events in an asymptomatic Korean population .


Non-invasive positive pressure ventilation has increasingly been chosen as the primary ventilation mode in respiratory distress syndrome ( RDS ) in preterm infants .


In order to further understand the application of various non-invasive positive pressure ventilation modes , we compared the advantages and disadvantages of three modes as a primary mode of ventilation in premature infants with RDS .


From December 2011 to March 2013 , 107 preterm infants with RDS who received intubation-pulmonary surfactant ( PS ) - extubation in our NICU were randomly divided ( by means of random number table ) into three groups based on the primary mode of ventilation : nasal continuous positive airway pressure [ NCPAP , n = 39 , male/female ratio was 27/12 , mean gestational age ( GA ) was ( 32.0 2.1 ) weeks , mean birth weight ( BW ) was ( 1752 457 ) g ] , bi-level positive airway pressure [ BiPAP , n = 35 , male/female ratio was 25/10 , GA was ( 31.4 2.0 ) weeks , BW was ( 1530 318 ) g ] , and synchronized bi-level positive airway pressure [ SBiPAP , n = 33 , male/female rate was 25/8 , GA was ( 31.5 2.2 ) weeks , BW was ( 1622 447 ) g ] .


Ventilation settings including FiO ( 2 ) were adjusted according to transcutaneous SPO ( 2 ) monitoring or blood gas analysis .


Various settings and adverse events were recorded as well .


The main parameter was the FiO ( 2 ) at 24 h post-positive-pressure ventilation .


Statistical analyses were performed using ( 2 ) test , rank sum test , one-way analysis of variance for least-significant difference value , paired-sample t-test , two related sample Wilcoxon signed rank sum test and Logistic regression .


The PaCO ( 2 ) ( mmHg , 1 mmHg = 0.133 kPa ) , oxygen index ( OI ) at 12-24 h , and FiO ( 2 ) at 24 h post-ventilation in BiPAP and SBiPAP groups were lower than that in NCPAP groups with significant difference ( 44 9 and 45 9 vs. 50 9 , 2.76 0.96 and 2.79 0.60 vs. 3.24 0.72 , 0.34 0.10 and 0.35 0.07 vs. 0.39 0.07 ; F = 4.456 , 5.146 and 4.123 ; P = 0.014 , 0.007 and 0.019 , respectively ) .


There was no significant difference between BiPAP and SBiPAP groups .


There was no significant difference among three groups ( all P > 0.05 ) in the following events : respiratory index ( RI ) at 12-24 h post-ventilation , abdominal distension , period of non-invasive ventilation , ratio of intubation for invasive ventilation if failed noninvasive ventilation , air-leak syndrome , neonatal necrotizing enterocolitis , periventricular-intraventricular haemorrhage , bronchopulmonary dysplasia , retinopathy of prematurity , mortality rate after 36 h of age or rate of abandon for discharge .


The independent risk factors for failure of non-invasive positive pressure ventilation were gender , gestational age , antepartum steroid at 24 h before birth to 7 d , and birth weight , with the OR ( 95 % confidence interval ) being 14.120 ( 1.135 , 175.662 ) , 2.862 ( 1.479 , 5.535 ) , 61.084 ( 3.115 , 1 198.031 ) , and 8.306 ( 1.488 , 46.383 ) , respectively .


As the primary mode of ventilation in premature infants with RDS , both BiPAP and SBiPAP are more beneficial than NCPAP in improving oxygenation and reducing CO ( 2 ) retention without increasing the incidence of adverse events .


The purpose of this study was to reexamine the factor pattern of the 12-item Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Scale ( FACIT-Sp-12 ) using exploratory factor analysis in people newly diagnosed with advanced cancer .


Principal components analysis ( PCA ) and 3 common factor analysis methods were used to explore the factor pattern of the FACIT-Sp-12 .


Factorial validity was assessed in association with quality of life ( QOL ) .


Principal factor analysis ( PFA ) , iterative PFA , and maximum likelihood suggested retrieving 3 factors : Peace , Meaning , and Faith .


Both Peace and Meaning positively related to QOL , whereas only Peace uniquely contributed to QOL .


This study supported the 3-factor model of the FACIT-Sp-12 .


Suggestions for revision of items and further validation of the identified factor pattern were provided .


We examined the impact of a prenatal exercise intervention on physical activity in 260 women at risk for gestational diabetes mellitus .


We randomized participants in the Behaviors Affecting Baby and You ( BABY ) Study , which took place from 2007 to 2012 , to either a 12-week individually tailored , motivationally matched exercise intervention ( n = 132 ) or to a comparison health and wellness intervention ( n = 128 ) .


We assessed physical activity with the Pregnancy Physical Activity Questionnaire .


We used linear mixed models to evaluate the impact of the interventions on change in physical activity according to intensity and type , total walking , and sedentary behavior .


Compared with the health and wellness arm , the exercise arm had significantly greater increases in sports or exercise activity ( 0.3 vs 5.3 metabolic equivalent of task [ MET ] hours/week ; P < .001 ) , and smaller declines in total activity ( -42.7 vs -2.1 MET hours/week ; P = .02 ) and activities of moderate to vigorous intensity ( -30.6 vs -10.6 MET hours/week ; P = .05 ) , and was more likely to achieve recommended guidelines for physical activity ( odds ratio = 2.12 ; 95 % confidence interval = 1.45 , 3.10 ) .


These findings extend the previous literature by demonstrating the benefits of a clinically feasible exercise intervention in an ethnically and socio-economically diverse population .


Given the increased risk of adverse maternal health outcomes in ethnic minority groups , these findings may have important implications for reducing health disparities .


Selenium is present in the active site of proteins important for thyroid hormone synthesis and metabolism .


The objective of this study is to investigate the effect of selenium supplementation in different doses on thyroid function , under conditions of suboptimal dietary selenium intake .


The Danish PREvention of Cancer by Intervention with SElenium pilot study ( DK-PRECISE ) is a randomized , double-blinded , placebo-controlled trial .


A total of 491 males and females aged 60-74 years were randomized to 100g ( n = 124 ) , 200g ( n = 122 ) , or 300g ( n = 119 ) selenium-enriched yeast or matching yeast-based placebo tablets ( n = 126 ) .


A total of 361 participants , equally distributed across treatment groups , completed the 5-year intervention period .


Plasma samples were analyzed for selenium and serum samples for TSH , free triiodothyronine ( FT3 ) , and free thyroxine ( FT4 ) at baseline , and after 6 months , and 5 years of supplementation .


Plasma selenium concentrations increased significantly and dose-dependently in treatment groups receiving selenium ( P < 0.001 ) .


Serum TSH and FT4 concentrations decreased significantly and dose-dependently by 0.066 mIU/l ( P = 0.010 ) and 0.11 pmol/l ( P = 0.015 ) , respectively , per 100g/day increase , with insignificant differences between 6 months and 5 years .


No significant effects were found for FT3 and FT3 : FT4 ratio .


In euthyroid subjects , selenium supplementation minutely and dose-dependently affects thyroid function , when compared with placebo , by decreasing serum TSH and FT4 concentrations .


Based on these findings , selenium supplementation is not warranted under conditions of marginal selenium deficiency .


However , a role for selenium supplementation in the treatment of autoimmune thyroid diseases is still unresolved .


We aimed to compare the effect of repaglinide and metformin monotherapy as an initial therapy in Chinese patients with newly diagnosed type 2 diabetes mellitus ( T2DM ) .


In this 15-week , open-labelled , parallel-controlled , randomised study , 60 Chinese drug-naive patients with newly diagnosed T2DM were randomised ( 2:1 ) to receive repaglinide or metformin monotherapy .


Primary endpoint was change in HbA1c from baseline to the end of the trial .


Secondary endpoints included changes in glycaemic variability , insulin sensitivity and - cell function .


Patients in both repaglinide and metformin groups achieved significant reductions in HbA1c ( -1.8 1.5 vs -1.6 1.5 % ) , FPG ( fasting blood glucose ) ( -1.7 1.7 vs -2.1 1.7 mmol/l ) and 2-hPPG ( post-prandial glucose ) ( -3.8 3.1 vs -3.8 3.6 mmol/l ) , with no statistical differences between the groups .


Glycaemic variability , glucose infusion rate and - cell function were all significantly improved from baseline in the two groups ( all P < 0.05 ) , without any statistical differences in the improvement between the groups .


Repaglinide and metformin achieved comparable efficacy in improving glycaemic control , reducing glycaemic variability , enhancing insulin sensitivity and ameliorating - cell function .


Therefore , repaglinide is an optional agent for initial therapy in Chinese patients with newly diagnosed T2DM .


Standard bowel cleansing for colon capsule endoscopy ( CCE ) requires a liquid diet and bowel laxatives for at least 2 days , which is a major drawback of this procedure and affects tolerance and acceptability .


To compare the quality of colon cleanliness achieved with one-day versus two-day bowel preparation in outpatients undergoing CCE .


Patients were randomly assigned to one of two groups : group I ( one-day schedule , n = 20 ) received a fiber-free diet and 3 L of polyethylene glycol ( PEG ) on day 0 ; group II ( two-day schedule , n = 20 ) received a liquid diet and 3 L of PEG in the evening of day -1 , and 1L of PEG in the early morning of day 0 .


In both groups , the patients received 15 mg bisacodyl on day -1 and one or two additional sodium phosphate ( NaP ) boosters following capsule ingestion .


Each colon segment was assessed for cleanliness using a four-point grading scale ( excellent = 1 , good = 2 , fair = 3 , and poor = 4 ) .


For the final analysis , colon cleanliness was rated as adequate ( good or excellent ) or inadequate ( fair or poor ) .


Overall colon cleanliness was adequate in 94 % ( CI 91-97 ) of patients in group I versus 80 % ( CI 72-88 ) in group II ( P = 0.27 ) .


No significant differences were observed in the per-segment quality of colon cleansing between the two groups .


CCE reached the rectum in 80 % ( CI 73-87 ) of patients in group I versus 75 % ( CI 67-83 ) in group II ( p = 0.59 ) .


The quality of colon cleanliness achieved with one-day bowel preparation is equivalent to that of the standard two-day schedule in patients undergoing CCE .


To compare the efficacy difference in the treatment of chronic pelvic pain syndrome of Sev-damp-heat stagnation pattern between acupoint catgut embedding therapy and western medication .


enty cases were randomized into a catgut embedding group ( 40 cases ) and a western medication group ( 30 cases ) at the ratio of 4 : 3 .


In the catgut embedding group , the catgut embedding therapy was applied to Sanyinjiao ( SP 6 ) , Quchi ( LI 11 ) , Huiyin ( CV 1 ) , Zusanli ( ST 36 ) , Zhongji ( CV 3 ) , Shenshu ( BL 23 ) , etc. .


The treatment was given once every two weeks , the treatment for 4 weeks was as one session and totally 2 sessions were required .


In the western medication group , tamsulosin hydrochloride capsules 0.2 mg , oral administration , once a day , and Indometacin sustained release tablets , 75 mg , once a day , 3 tablets each time were prescribed .


The symptom score of TCM , score of NIH Chronic Prostatitis Symptom Index ( NIH-CPSI ) , lecithin body number in prostatic fluid , ( SAS ) score of Self-Rating Anxiety Scale and score of Self-Rating Depression Scale ( SDS ) were compared before and after treatment in the patients of the two groups .


The efficacy was evaluated in the two groups .


( 1 ) The total effective rate was 91.9 % ( 34/37 ) in the catgutembedding group and was 86.2 % ( 25/29 ) in the western medication group .


The efficacy in the catgutembedding group was better than that in the western medication group ( P < 0.05 ) .


( 2 ) The symptom score of TCM was all reduced significantly after treatment in the two groups ( both P < 0.01 ) , and the result in the catgut embedding group was superior to the western medication group ( 6.42 + / -2.81 vs 10.99 + / -3.11 , P < 0.01 ) .


( 3 ) Lecithin body number was increased apparently in the two groups after treatment ( both P < 0.01 ) , and the result in the catgut-embedding group was superior to the western medicine group ( 33.56 + / -5.88 vs 29.78 + / -7.06 , P < 0.05 ) .


( 4 ) Total score of NIH-CPSI , score of pain , score of SAS and score of SDS were all improved apparently after treatment in the two groups ( all P < 0.01 ) , and the results in the catgut embedding group were superior to the western medication group ( P < 0.01 , P < 0.05 ) .


The acupoint catgut embedding therapy achieves the superior efficacy on chronic pelvic pain syndrome of damp-heat stagnation pattern as compared with conventional western medicine .


This therapy relieves clinical symptoms , improves the states of anxiety and depression and increases lecithin body number obviously .


A recent paper reported the outcomes of a study examining a new self-guided internet-delivered treatment , the Wellbeing Course , for symptoms of anxiety or depression .


This study found the intervention resulted in significant symptom reductions .


It also found that automated emails increased treatment completion and clinical improvements in a subsample with elevated anxiety and depression .


To examine the clinical outcomes and the effect of automated emails at 12 months post-treatment .


Participants , who were randomly allocated to a Treatment Plus Automated Emails Group ( TEG ; n = 100 ) , a standard Treatment Group ( TG ; n = 106 ) or delayed-treatment Waitlist Control Group ( Control ; n = 51 ) , were followed up at 12 months post-treatment .


Eighty-one percent , 78 % and 87 % of participants in the TEG , TG and treated Waitlist Control Group provided symptom data at 12-month follow-up , respectively .


The primary outcome measures were the Patient Health Questionnaire-9 Item Scale ( PHQ-9 ) and the Generalized Anxiety Disorder-7 Item Scale ( GAD-7 ) .


Significant improvements in symptoms of anxiety and depression were observed over time in both the TEG and TG ( Fs > 69 , ps < .001 ) these were sustained from post-treatment to 12-month follow-up ( ps > .05 ) , and were associated with large effect sizes .


No statistically significant differences in symptoms were found between the TEG and TG at post-treatment , 3-month or 12-month follow-up .


Previously reported symptom differences between TEG and TG participants with comorbid symptoms were no longer present at 12-month follow-up ( ps > .70 ) .


The overall benefits of the Wellbeing Course were sustained at 12-month follow-up .


Although automated emails facilitated Course completion and reductions in symptoms for participants with comorbid anxiety and depression from pre-post treatment , these differences were no longer observed at 12-month follow-up .


The results indicate that automated emails promote more rapid treatment response for people with elevated and comorbid symptoms , but may not improve longer term outcomes .


Australian and New Zealand Clinical Trials Registry ACTRN12610001058066 .


To explore the differential effect of a multifaceted intervention on hospital-based maternal mortality between patients with cesarean and vaginal delivery in low-resource settings .


We reanalyzed the data from a major cluster-randomized controlled trial , QUARITE ( Quality of care , Risk management and technology in obstetrics ) .


These subgroup analyses were not pre-specified and were treated as exploratory .


The intervention consisted of an initial interactive workshop and quarterly educational clinically oriented and evidence-based outreach visits focused on maternal death reviews ( MDR ) and best practices implementation .


The trial originally recruited 191,167 patients who delivered in each of the 46 participating hospitals in Mali and Senegal , between 2007 and 2011 .


The primary endpoint was hospital-based maternal mortality .


Subgroup-specific Odds Ratios ( ORs ) of maternal mortality were computed and tested for differential intervention effect using generalized linear mixed model between two subgroups ( cesarean : 40,975 ; and vaginal delivery : 150,192 ) .


The test for homogeneity of intervention effects on hospital-based maternal mortality among the two delivery mode subgroups was statistically significant ( p-value : 0.0201 ) .


Compared to the control , the adjusted OR of maternal mortality was 0.71 ( 95 % CI : 0.58-0 .82 , p = 0.0034 ) among women with cesarean delivery .


The intervention had no significant effect among women with vaginal delivery ( adjusted OR 0.87 , 95 % CI 0.69-1 .11 , p = 0.6213 ) .


This differential effect was particularly marked for district hospitals .


Maternal deaths reviews and on-site training on emergency obstetric care may be more effective in reducing maternal mortality among high-risk women who need a cesarean section than among low-risk women with vaginal delivery .


Tuberculosis is a public health problem in Cameroon , just like in many other countries in the world .


The National Tuberculosis Control Programme ( PNLT ) put in place by the state , aims to fight tuberculosis through the implementation of international directives ( Directly Observed Treatment Short , DOTS ) .


Despite the deployment of this strategy across the world , its implementation is difficult in the context of low-resource countries .


Some expected results are not achieved .


In Cameroon , the cure rate for patients with sputum positive pulmonary tuberculosis ( TPM + ) after 6 months is only about 65 % , 20 % below the target .


This is mainly due to poor patient adherence to treatment .


By relying on the potential of mobile Health , the objective of this study is to evaluate the effect of SMS reminders on the cure rate of TPM + patients , measured using 6-month bacilloscopy .


This is a blinded , randomised controlled multicentre study carried out in Cameroon .


The research hypothesis is that sending daily SMS messages to remind patients to take their prescribed tuberculosis medication , together with the standard DOTS strategy , will increase the cure rate from 65 % ( control group : DOTS , no SMS intervention ) to 85 % ( intervention group : DOTS , with SMS intervention ) in a group of new TPM + patients .


In accordance with each treatment centre , the participants will be randomly allocated into the two groups using a computer program : the intervention group and the control group .


A member of the research team will send daily SMS messages .


Study data will be collected by health professionals involved in the care of patients .


Data analysis will be done by the intention-to-treat method .


The achieving of expected outcomes by the PNLT through implementation of DOTS requires several challenges .


Although it has been demonstrated that the DOTS strategy is effective in the fight against tuberculosis , its application remains difficult in developing countries .


This study explores the potential of mHealth to support DOTS strategy .


It will gather new evidence on the effectiveness of mHealth-based interventions and SMS reminders in the improvement of treatment adherence and the cure rate of tuberculosis patients , especially in a low-resource country such as Cameroon .


The trial is registered on the Pan-African Clinical Trials Registry ( http://www.pactr.org ) under unique identification number : PACTR201307000583416 .


Depression is common in nursing home ( NH ) patients with dementia , and often clustered with anxiety and other mood symptoms .


An association between pain and depressive symptoms has been reported , but the impact of pain management on depression and other mood symptoms has not been investigated .


Secondary analyses of a cluster randomized clinical trial examine the response of dementia-related mood symptoms to a Stepwise Protocol of Treating Pain .


Three-hundred fifty-two patients with moderate and severe dementia and significant behavioural disturbances , related to 60 clusters ( i.e. clusters defined as single independent NH units ) in 18 NHs of Western Norway , were included .


All patients in the intervention group received individual daily pain treatment with paracetamol , extended release morphine , buprenorphine transdermal patch or pregabaline for 8weeks , with additional follow-up assessment 4weeks after completion of the intervention .


Clusters randomized to control received usual treatment .