The purpose of this study was to determine whether an individualized respiratory muscle training device combined with conventional physical therapy exercise can improve the pulmonary function and exercise capacity of stroke patients .


Twenty stroke patients were randomly assigned to an exercise group ( n = 10 ) or a control group ( n = 10 ) .


Over 4 weeks , each group participated in exercise training interventions 3 times per week .


In each session , the control group received basic exercise treatments for 30 min , followed by an automated full-body workout for 20 min .


The exercise group performed the same exercise regimen as the control group , as well as an additional respiratory muscle training regimen using a respiratory exercise device for 20 min .


Pulmonary function of forced vital capacity ( FVC ) , forced expiratory volume at 1 s ( FEV1 ) , FEV1/FVC , and peak expiratory flow ( PEF ) and exercise capacity of a 6-min walking test and Shortness of Breath Modified Borg Dyspnea Scale ( SBMBDS ) scores were assessed before and after the training .


A significant intergroup difference was observed in the FVC , FEV1 , PEF , 6MWT , and SBMBDS scores ( p < 0.05 ) .


These findings suggest that exercise of the respiratory muscles using an individualized respiratory device had a positive effect on pulmonary function and exercise capacity and may be used for breathing rehabilitation in stroke patients .


Approximately , 20-30 % of patients with gastro-esophageal reflux disease ( GERD ) experience persistent symptoms despite treatment with proton pump inhibitors ( PPIs ) .


These patients may have underlying dysmotility ; therefore , targeting gastric motor dysfunction in addition to acid inhibition may represent a new therapeutic avenue .


The aim of this study was to assess the pharmacodynamic effect of the prokinetic agent revexepride ( a 5-HT4 receptor agonist ) in patients with GERD who have persistent symptoms despite treatment with a PPI .


This was a phase II , exploratory , multicenter , randomized , placebo-controlled , double-blind , parallel-group study in patients with GERD who experienced persistent symptoms while taking a stable dose of PPIs ( ClinicalTrials.gov identifier : NCT01370863 ) .


Patients were randomized to either revexepride ( 0.5 mg , three times daily ) or matching placebo for 4 weeks .


Reflux events and associated characteristics were assessed by pH/impedance monitoring and disease symptoms were assessed using electronic diaries and questionnaires .


In total , 67 patients were enrolled in the study .


There were no significant differences between study arms in the number , the mean proximal extent or the bolus clearance times of liquid-containing reflux events .


Changes from baseline in the number of heartburn , regurgitation , and other symptom events were minimal for each treatment group and no clear trends were observed .


No clear differences were seen in reflux parameters between the placebo and revexepride groups .


The hands of hospital personnel are considered to be important for colonization and infection of patients with Candida spp .


The aim of this study was to evaluate the effectiveness of different hand disinfectants in reducing the carriage of Candida species on the hands of hospital personnel .


A controlled study was conducted at Duzce University School of Medicine Hospital .


Eighty hospital personnel were included in the trial .


Subjects were divided into 4 groups according to hand hygiene procedures : group 1 , hand rubbing with alcohol-based solution ; group 2 , hand washing with 4 % chlorhexidine gluconate ; group 3 , hand washing with 7.5 % povidone-iodine ; group 4 , hand washing with plain soap and water .


The hands of all participants were tested by culture with the broth wash technique .


Hand carriage of Candida spp .


was lower in the 4 % chlorhexidine gluconate group ( 10.5 % , p = 0.006 ) , in the 7.5 % povidone-iodine group ( 18.7 % , p = 0.043 ) , and in the alcohol-based hand rub group ( 21.1 % , p = 0.048 ) compared to the group washing hands with plain soap and water ( 50 % ) .


The use of hand disinfectant containing antimicrobial agents is more effective than hand washing with water and soap in reducing carriage of Candida on the hands of hospital personnel .


It is recommended that hospital personnel use an antimicrobial hand disinfectant in units where there is a high risk of Candida infection .


This study sought to examine the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation ( CN-NINM ) , on the walking ability of people with MS who exhibited a dysfunctional gait .


We hypothesized that subjects who received electrical stimulation would have greater improvement than those who had a control device after a 14-week intervention .


Gait disturbance is a common problem for people with multiple sclerosis ( MS ) .


Current management may include exercise , pharmacology , functional electrical stimulation , compensatory strategies , use of assistive devices , and implanted electrical devices .


We have developed an effective rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain .


The study is a within-subject blinded randomized control design .


Twenty chronic MS subjects with an identified gait disturbance were assigned to either an active or control group .


Both groups completed a 14-week intervention program using a standardized combination of exercise and a device that provided electrical stimulation to the tongue .


Those in the active group received electrical stimulation on the tongue that they could perceive .


Those in the control group used a device that did not provide a physiologically significant stimulus and was not perceivable .


Subjects were assessed with the Dynamic Gait Index ( DGI ) .


The DGI scores improved for both groups .


There were significant between-group differences , with the active group showing statistically greater improvement than the control group mean .


People with MS demonstrated improved gait with CN-NINM training in a pilot randomized controlled trial .


This study suggests that tongue-based neurostimulation may amplify the benefits of exercise for improving gait in people with chronic MS.


Higher-level gait disorder ( HLGD ) in older adults is characterized by postural instability , stepping dysrhythmicity , recurrent falls and progressive immobility .


Cognitive impairments are frequently associated with HLGD .


The aim of this study was to compare gait and cognitive performance before and after the use of rivastigmine in patients with HLGD , free from cognitive impairment or Parkinsonism .


Fifteen non-demented patients with HLGD ( age 79.2 5.9 years ; 11 women ; Mini-Mental State Examination [ MMSE ] 28.3 1.4 ) received escalating doses of rivastigmine for 12 weeks in an open-label , pilot study .


They were assessed before and after treatment ( week 0 and week 12 ) , and after a 4-week washout period ( week 16 ) .


Assessments included the Mindstreams computerized neuropsychological battery , Activities-specific Balance Confidence Scale , State-Trait Anxiety Inventory , Geriatric Depression Scale , Timed Up and Go ( TUG ) test , gait speed and stride time variability .


One-way multiple analysis of variance tests for repeated measures were used , and Pillai 's trace test was considered as robust to investigate significant differences .


The mean dose of rivastigmine during the 8-12 week period was 5.1 2.3 mg/day .


A positive effect was observed on the Mindstreams memory subscale and anxiety scores [ Pillai 's trace : F ( 6,724 ) = 0.508 , p = 0.010 ; and F ( 7,792 ) = 0.545 , p = 0.006 , respectively , over the course of the study ] as well as on mobility ( TUG test ) [ Pillai 's trace : F ( 4,863 ) = 0.448 ; p = 0.028 ] , whereas gait speed and stride time variability did not change .


The use of relatively low-dose rivastigmine did not affect gait speed and stride time variability ; however , the general mobility and anxiety were improved .


These preliminary results warrant a larger , randomized , placebo-controlled study .


Accumulation of bacteria in the pharynx is one of the risk factors of pneumonia due to ventilation .


One of the methods of prevention from accumulation of bacteria in the pharynx is the use of oral solutions .


Chlorhexidine is considered as the gold standard , but it has various side effects .


Present study was aimed to determine and compare anti-bacterial effects of the chlorhexidine gluconate 0.2 % , herbal mouthwash of Matrica ( chamomile extracts ) 10 % , PersicaTM 10 % and normal saline in intensive care unit patients .


In this double blind randomized clinical trial , 80 patients who were admitted in ICU divided into four groups of 20 patients each one .


Researchers applied PersicaTM to group one , chlorhexidine gluconate mouth wash 0.2 % to group two and third group received Matrica , finally in the control group , normal saline were used .


In order to culturing of Staphylococcus aureus and S. pneumoniae , salivary samples were obtained without any stimulation after six minimums oral rinsing .


The data were processed in SPSS17 software and analyzed by appropriate statistical tests .


Decreased rate of bacterial colonies after intervention in the whole four groups was significant ( p < 0.001 ) .


The mouth wash of chlorhexidine ( p < 0.001 ) , PersicaTM ( p : 0.008 ) and Matrica ( p : 0.01 ) had a significant antibacterial effect on S. aureus and S. pneumoniae ( p < 0.001 ) .


Herbal oral mouthwash of persica and matrica has the effect on S. pneumoniae and S. aureus of oropharynx area in mechanically ventilated patients .


However , there is a need for further research to be considered as an alternative to chlorhexidine for prevention of VALP in ICU patients .


Preliminary evaluation of efficacy and safety of uzara use in treatment of moderate and severe primary dysmenorrhea in comparison to ibuprofen .


This randomized , comparative two way cross-over study comprised 60 single female students at Faculty of Medicine , Ain Shams University , Egypt , aged 19-28 years with moderate ( n = 46 ) or severe ( n = 14 ) primary dysmenorrhea .


Participants were randomized to take either uzara ( 80 mg/8 hours for two doses , then 40 mg/8 hours ) then ibuprofen ( 400 mg/6 hours ) in two subsequent cycles or vice versa .


The pain intensity , using VAS , was recorded immediately before taking the medication ( 0 hour ) and after 4 , 12 , 24 , 48-60 , 96-120 hours .


Main outcome measures included effectiveness of pain relief defined as drop of VAS to 3 or less , patient 's global evaluation of the drug , absence from school , the use of a rescue medication , and , in those who continued the treatment , the pain intensity difference ( PID ) at different points after start of medication and its sum ( SPID ) .


Uzara was comparably effective to ibuprofen ( 78.3 % vs. 86.7 % of cycles ; respectively ) , with comparable rates of effectiveness on global evaluation ( being around 50 % for either drug ) , and rates of school absences ( 11.7 % vs. 13.3 % ; respectively ) .


The need for rescue medication was different ( 18.3 % and 10 % ; respectively ) , albeit with no statistical significance .


The means of PID at different time points and SPID were comparable , with significantly lower average mean of VAS scores compared to that felt with no medication ( 1.6 vs. 6.8 , p < 0.001 ) .


Side effects were less with uzara than ibuprofen ( 0 % vs. 8.3 % , p < 0.05 ) .


Uzara might be as effective as ibuprofen in management of primary dysmenorrhea but with less side effects .


These findings need to be confirmed by a properly designed trial with a larger sample size .


Current Controlled Trials ISRCTN25618258 .


We evaluated the efficacy and safety of add-on treatment with a 3-adrenoceptor agonist ( mirabegron ) for overactive bladder symptoms remaining after 1-blocker ( tamsulosin ) treatment in men with benign prostatic obstruction .


Patients with benign prostatic obstruction with urinary urgency at least once per week and a total OABSS of 3 or more points after 8 or more weeks of treatment with tamsulosin were enrolled in the study .


They were randomly allocated to receive 0.2 mg tamsulosin daily or 0.2 mg tamsulosin and 50 mg mirabegron daily for 8 weeks .


The primary end point was change in total OABSS .


Safety assessments included change in post-void residual urine volume and adverse events .


From January 2012 through September 2013 a total of 94 patients were randomized .


Of these patients 76 completed the protocol treatment .


In the full analysis set the change in total OABSS during the treatment period was significantly greater in the combination group than in the monotherapy group ( -2.21 vs -0.87 , p = 0.012 ) .


The changes in scores for urinary urgency , daytime frequency , International Prostate Symptom Score storage symptom subscore and quality of life index at 8 weeks were significantly greater in the combination group .


The change in post-void residual urine volume was significantly greater in the combination group .


Although 6 patients experienced adverse events in the combination group , urinary retention was observed in only 1 patient .


Combined tamsulosin and mirabegron treatment is effective and safe for patients with benign prostatic obstruction who have overactive bladder symptoms after tamsulosin monotherapy .


To report on oral-health-related characteristics , beliefs , and behaviours among participants in a randomised control trial of an intervention to prevent early childhood caries ( ECC ) among Mori children , and to determine whether there were any systematic differences between the intervention and control groups at baseline .


Baseline measurements from a randomised control trial ( involving 222 pregnant Mori women allocated randomly to either Intervention or Delayed groups ) which is currently underway .


The rohe ( tribal area ) of Waikato-Tainui .


Self-report information collected on sociodemographic characteristics , pregnancy details , self-reported general and oral health and health-related behaviours , and oral health beliefs .


Other than those in the Delayed group being slightly older , on average , there were no significant differences between the two groups .


Some 37.0 % were expecting their first child .


Most reported good health ; 43.6 % were current smokers , and 26.4 % had never smoked .


Only 8.2 % were current users of alcohol .


Almost all were dentate , and 57.7 % described their oral health as fair or poor .


One in six had had toothache in the previous year ; 33.8 % reported being uncomfortable about the appearance of their teeth , and 27.7 % reported difficulty in eating .


Dental service-use was relatively low and symptom-related ; 78.9 % needed to see a dentist .


Overall , most of the sample believed that it was important to avoid sweet foods , visit dentists and to brush the teeth , while about half thought that using fluoride toothpaste and using floss were important .


Some 38.2 % felt that drinking fluoridated water was important .


Oral-health-related fatalism was apparent , with 74.2 % believing that most people usually get dental problems , 58.6 % believing that most people will need extractions at some stage , and that most children eventually get dental caries .


Mothers ' important role in nurturing the well-being of the young child includes the protection and maintenance of the growing child 's oral health ( or ukaipo niho ) .


The findings provide important insights into Mori mothers ' oral health knowledge , beliefs and practices .


Several therapies have been used in the treatment of chronic low back pain ( LBP ) , including various exercise strategies and spinal manipulative therapy ( SMT ) .


A common belief is that spinal motion changes in particular ways in direct response to specific interventions , such as exercise or spinal manipulation .


The purpose of this study was to assess changes in lumbar region motion for more than 12 weeks by evaluating four motion parameters in the sagittal plane and two in the horizontal plane in LBP patients treated with either exercise therapy or spinal manipulation .


Secondary analysis of a subset of participants from a randomized clinical trial .


One hundred ninety-nine study participants with LBP of more than 6 weeks ' duration who had spinal motion measures obtained before and after the period of intervention .


Lumbar region spinal kinematics sampled using a six-degree-of-freedom instrumented spatial linkage system .


Trained therapists collected regional lumbar spinal motion data at baseline and 12 weeks of follow-up .


The lumbar region spinal motion data were analyzed as a total cohort and relative to treatment modality ( high dose , supervised low-tech trunk exercise , SMT , and a short course of home exercise and self-care advice ) .


The study was supported by grants from Health Resources and Services Administration , Danish Agency for Science Technology and Innovation , Danish Chiropractors Research Foundation , and the University of Southern Denmark .


No conflicts of interest reported .


For the cohort as a whole , lumbar region motion parameters were altered over the 12-week period , except for the jerk index parameter .


The group receiving spinal manipulation changed significantly in all , and the exercise groups in half , the motion parameters included in the analysis .


The spinal manipulation group changed to a smoother motion pattern ( reduced jerk index ) , whereas the exercise groups did not .


This study provides evidence that spinal motion changes can occur in chronic LBP patients over a 12-week period and that these changes are associated with the type of treatment .


To propose a rehabilitation protocol able to produce immediate and long-term beneficial effects on level of disability and overall performance in ADLs .


Forty-one FM patients were randomized to an exercise and educational-behavioral programme group ( experimental group , EG = 21 ) or to a control group ( CG = 20 ) .


Each subject was evaluated before , at the end ( T1 ) , and after 6 months ( T6 ) from the conclusion of the rehabilitation treatment using the Fibromyalgia Impact Questionnaire ( FIQ ) , the visual analogue scale ( VAS ) , the Health Assessment Questionnaire ( HAQ ) , the fatigue severity scale ( FSS ) , the 6-minute walking test ( 6MWT ) , tender points count ( TPC ) , and spinal active range of motion .


The exercise protocol included 20 sessions consisting in self-awareness , stretching , strengthening , spine flexibility , and aerobic exercises , which patients were subsequently educated to perform at home .


The two groups were comparable at baseline .


At T1 , the EG showed a positive trend in FIQ , VAS , HAQ , and FSS scales and significant improvement in 6MWT and in most spinal active range of motion measurements ( P between 0.001 and 0.04 ) .


The positive results were maintained at the follow-up .


The proposed programme was well tolerated and produced immediate and medium-term beneficial effects improving function and strain endurance .


This trial is registered with DRKS00005071 on DRKS .


An intracuff pressure of 80cm H2 O in the adult-sized laryngeal mask airway Supreme has been recommended to obtain a higher oropharyngeal leak pressure ( OLP ) .


However , the intracuff pressure for the higher OLP in the pediatric laryngeal mask airway Supreme could be different from that in the adult-sized laryngeal mask airway Supreme .


Thus , we measured and compared OLP at three intracuff pressures of 40 , 60 , and 80cm H2 O in the pediatric laryngeal mask airway Supreme .


This study was designed as a randomized crossover study and enrolled 36 children , aged 0-108months and 5-30kg in weight .


After insertion of the laryngeal mask airway Supreme , oropharyngeal leak pressure ( OLP ) was measured at intracuff pressures of 40 , 60 , and 80cm H2 O according to one of six sequences produced on the basis of 36 Williams crossover design .


During the intraoperative period , the laryngeal mask airway Supreme was maintained using the last intracuff pressure of the allocated sequence .


The intraoperative and postoperative complications were compared among three maintenance intracuff pressures .


OLP at the intracuff pressure of 60cm H2 O was significantly higher than that of 40cm H2 O ( 17.93.9 vs 16.94.2 cm H2 O , P = 0.004 ) and was comparable with that of 80cm H2 O ( 17.93.9 vs 17.84.6 cm H2 O , P = 0.938 ) .


There were no significant differences of intraoperative and postoperative complications among the three maintenance intracuff pressures .


Our results suggest that the use of an intracuff pressure of 60cm H2 O in pediatric laryngeal mask airway Supreme provides a higher OLP compared with 40cm H2 O.


Experimental and clinical pain studies are conflicting regarding whether individuals report heightened or dampened pain sensitivity in the presence of other men or women .


In the present preliminary study , two small medical record reviews of patients admitted for emergency care were conducted to examine the possibility that patients may report differential pain intensity to male and female health care examiners .


The study also sought to determine whether these effects are moderated by and , thus , only detectable by examining patients at different pain ( debilitation ) levels .


Pain intensity scores were extracted from two medical record reviews of patients admitted for emergency care ( n = 64 and n = 135 , respectively ) .


Pain intensity was measured using an 11-point numerical scale during standard triage assessments and the sex of the examiner was recorded .


Mean pain scores reported to male and female emergency staff did not differ in either set of medical records .


However , when patients were split between low and high pain levels , male patients reported higher pain scores to male practitioners when experiencing relatively low pain levels , and both male and female patients reported higher pain scores to female practitioners when experiencing relatively high pain levels .


The statistical magnitudes of these effects were large , suggesting that this phenomenon may be a pervasive feature in clinical settings and experimental pain studies .


These preliminary findings warrant larger-scale investigations of social contextual influences on patient pain reports , which are necessary for creating more standardized protocols for reliably assessing and treating patient pain experiences .


To compare the effect of adding canrenone or hydrochlorothiazide ( HCTZ ) to valsartan/amlodipine combination on urinary albumin excretion ( UAE ) in microalbuminuric type 2 diabetic hypertensives .


After a 2-week placebo period and after 4 weeks of valsartan 160 mg plus amlodipine 5 mg combination , 120 patients whose blood pressure ( BP ) was not controlled ( > 130/80 mmHg ) were randomized to canrenone 25 mg or HCTZ 12.5 mg in addition to the previous therapy for 24 weeks .


After the first 6 weeks of triple therapy , canrenone or HCTZ doses were doubled in the patients whose BP was yet uncontrolled .


At the end of each period ( placebo , dual combination and triple combination therapy ) , clinic and ambulatory BP measurements were recorded and 24 h UAE was evaluated .


Both triple combinations produced greater clinical and ambulatory BP reduction than dual therapy , with no difference between the two groups .


UAE was reduced by both regimens , but the decrease associated with canrenone add-on therapy was more pronounced .


At week 24 , UAE decreased by 45.3 % in the canrenone group and by 20.3 % in the HCTZ group ( p < 0.01 ) .


These findings indicate that , despite similar BP-lowering effect , the addition of canrenone to valsartan/amlodipine combination was more effective in reducing UAE than HCTZ addition .


To evaluate the effect of early aqueous suppressant treatment on Ahmed glaucoma valve ( AGV ) surgery outcomes .


Randomized clinical trial .


Ninety-four eyes of 94 patients with refractory glaucoma .


After AGV implantation , 47 cases ( group 1 ) received topical timolol-dorzolamide fixed-combination drops twice daily when intraocular pressure ( IOP ) exceeded 10 mmHg , whereas 47 controls ( group 2 ) received conventional stepwise treatment when IOP exceeded target pressure .


Main outcome measures included IOP and success rate ( 6 mmHg < IOP < 15 mmHg and IOP reduction of at least 30 % from baseline ) .


Other outcome measures included best-corrected visual acuity , complications , and hypertensive phase frequency .


Groups 1 and 2 were both followed up for a mean of 4511.6 and 47.27.4 weeks , respectively ( P = 0.74 ) .


Mixed model analysis revealed a significantly greater IOP reduction in group 1 at all intervals ( P < 0.001 ) .


At 1 year , the cases exhibited a significantly higher success rate ( 63.2 % vs. 33.3 % ; P = 0.008 ) and reduced hypertensive phase frequency ( 23.4 % vs. 66.0 % ; P < 0.001 ) .


Early aqueous suppressant treatment may improve AGV implantation outcomes in terms of IOP reduction , success rate , and hypertensive phase frequency .


To assess clinician attitudes and experiences in Health eHearts , a quality recognition and financial incentive program using health information technology .


Survey of physicians .


A survey was administered to 140 lead clinicians at each participating practice .


Survey domains included clinicians ' experiences and attitudes toward the selected clinical quality measures focused on cardiovascular care , use of electronic health records ( EHRs ) , technical assistance visits , quality measurement reports , and incentive payments .


Responses were compared across groups of practices receiving financial incentives with those in the control ( no financial rewards ) .


Survey response rate was 74 % .


The majority of respondents reported receiving and reviewing the quality reports ( 89 % ) , agreed with the prioritization of measures ( 89 % ) , and understood the information given in the quality reports ( 95 % ) .


Over half of the respondents had a quality improvement visit ( 56 % ) , with incentive clinicians more likely to have had a visit compared with the control group ( 68 % vs 43 % , P = .01 ) .


The incentive group respondents ( 92 % ) were more likely to report using clinical decision support system alerts than control group respondents ( 82 % , P = .11 ) .


Clinicians in both incentive and control groups reported positive experiences with the program .


No differences were detected between groups regarding agreement with selected clinical measures or their relevance to the patient population .


However , clinicians in the incentive group were more likely to review quarterly performance reports and access quality improvement visits .


Incentives may be used to further engage clinicians operating in small independently owned practices to participate in quality improvement activities .


Selenium is found in soils and is essential for human antioxidant defense and immune function .


In Malawi , low soil selenium and dietary intakes coupled with low plasma selenium concentrations in HIV infection could have negative consequences for the health of HIV-infected mothers and their exclusively breastfed infants .


We tested the effects of lipid-based nutrient supplements ( LNS ) that contained 1.3 times the Recommended Dietary Allowance of sodium selenite and antiretroviral drugs ( ARV ) on maternal plasma and breast-milk selenium concentrations .


HIV-infected Malawian mothers in the Breastfeeding , Antiretrovirals , and Nutrition study were randomly assigned at delivery to receive : LNS , ARV , LNS and ARV , or a control .


In a subsample of 526 mothers and their uninfected infants , we measured plasma and breast-milk selenium concentrations at 2 or 6 ( depending on the availability of infant samples ) and 24 wk postpartum .


Overall , mean ( SD ) maternal ( range : 81.2 20.4 to 86.2 19.9 g/L ) and infant ( 55.6 16.3 to 61.0 15.4 g/L ) plasma selenium concentrations increased , whereas breast-milk selenium concentrations declined ( 14.3 11.5 to 9.8 7.3 g/L ) from 2 or 6 to 24 wk postpartum ( all P < 0.001 ) .


Compared with the highest baseline selenium tertile , low and middle tertiles were positively associated with a change in maternal plasma or breast-milk selenium from 2 or 6 to 24 wk postpartum ( both P < 0.001 ) .


With the use of linear regression , we showed that LNS that contained selenium and ARV were not associated with changes in maternal plasma and breast-milk selenium , but maternal selenium concentrations were positively associated with infant plasma selenium at 2 or 6 and 24 wk postpartum ( P < 0.001 ) regardless of the study arm .


Selenite supplementation of HIV-infected Malawian women was not associated with a change in their plasma or breast-milk selenium concentrations .


Future research should examine effects of more readily incorporated forms of selenium ( ie , selenomethionine ) in HIV-infected breastfeeding women .


Skin and skin-structure infections are common in ambulatory settings .


However , the efficacy of various antibiotic regimens in the era of community-acquired methicillin-resistant Staphylococcus aureus ( MRSA ) is unclear .


We enrolled outpatients with uncomplicated skin infections who had cellulitis , abscesses larger than 5 cm in diameter ( smaller for younger children ) , or both .


Patients were enrolled at four study sites .


All abscesses underwent incision and drainage .


Patients were randomly assigned in a 1:1 ratio to receive either clindamycin or trimethoprim-sulfamethoxazole ( TMP-SMX ) for 10 days .


Patients and investigators were unaware of the treatment assignments and microbiologic test results .


The primary outcome was clinical cure 7 to 10 days after the end of treatment .


A total of 524 patients were enrolled ( 264 in the clindamycin group and 260 in the TMP-SMX group ) , including 155 children ( 29.6 % ) .


One hundred sixty patients ( 30.5 % ) had an abscess , 280 ( 53.4 % ) had cellulitis , and 82 ( 15.6 % ) had mixed infection , defined as at least one abscess lesion and one cellulitis lesion .


S. aureus was isolated from the lesions of 217 patients ( 41.4 % ) ; the isolates in 167 ( 77.0 % ) of these patients were MRSA .


The proportion of patients cured was similar in the two treatment groups in the intention-to-treat population ( 80.3 % in the clindamycin group and 77.7 % in the TMP-SMX group ; difference , -2.6 percentage points ; 95 % confidence interval [ CI ] , -10.2 to 4.9 ; P = 0.52 ) and in the populations of patients who could be evaluated ( 466 patients ; 89.5 % in the clindamycin group and 88.2 % in the TMP-SMX group ; difference , -1.2 percentage points ; 95 % CI , -7.6 to 5.1 ; P = 0.77 ) .


Cure rates did not differ significantly between the two treatments in the subgroups of children , adults , and patients with abscess versus cellulitis .


The proportion of patients with adverse events was similar in the two groups .


We found no significant difference between clindamycin and TMP-SMX , with respect to either efficacy or side-effect profile , for the treatment of uncomplicated skin infections , including both cellulitis and abscesses .


( Funded by the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences , National Institutes of Health ; ClinicalTrials.gov number , NCT00730028 . )


Insulin resistance and sympathetic nervous system overactivity are closely associated and contribute to cardiovascular risk .


The objective of the study was to test the hypotheses that pharmacological improvement in insulin sensitivity would ( 1 ) attenuate sympathetic neural drive and ( 2 ) enhance neuronal norepinephrine uptake .


A randomized , double-blind trial was conducted in 42 obese , unmedicated individuals with metabolic syndrome ( mean age 56 1 y , body mass index 34 0.6 kg/m ( 2 ) ) who received 12 weeks of pioglitazone ( PIO ; 15 mg for 6 wk , then 30 mg daily ) or matched placebo .


Clinical measurements included whole-body norepinephrine kinetics [ spillover rate , plasma clearance , and the steady state ratio of tritiated 3,4-dihydroxyphenylglycol to tritiated norepinephrine ( [ ( 3 ) H ] - DHPG to [ ( 3 ) H ] - NE ) as an index of neuronal uptake-1 ] , muscle sympathetic nerve activity , spontaneous baroreflex sensitivity , euglycemic hyperinsulinemic clamp , oral glucose tolerance test , ambulatory blood pressure , and Doppler echocardiography .


PIO treatment increased glucose uptake by 35 % and was accompanied by significant reductions in diastolic blood pressure and improved left ventricular diastolic and endothelial function .


Resting muscle sympathetic nerve activity burst frequency decreased by -6 3 burst/min compared with baseline ( P = .03 ) , but the magnitude of change was not different from placebo ( P = .89 ) .


Norepinephrine spillover and clearance rates and baroreflex sensitivity were unchanged .


Post hoc subgroup analyses revealed an 83 % increase in [ ( 3 ) H ] - DHPG to [ ( 3 ) H ] - NE ratio in hyperinsulinemic ( P = .04 ) but not normoinsulinemic subjects ( time group interaction , P = .045 ) .


Change in [ ( 3 ) H ] - DHPG to [ ( 3 ) H ] - NE ratio correlated with improvements in diastolic blood pressure ( r = -0.67 , P = .002 ) , the ratio of early ( E ) to late ( A ) peak transmitral diastolic inflow velocity ( r = 0.62 , P = .008 ) , E wave deceleration time ( r = -0.48 , P = .05 ) , and insulin area under the curve0-120 during the oral glucose tolerance test ( r = -0.42 , P = .08 ) .


Compared with placebo , PIO does not affect resting sympathetic drive or norepinephrine disposition in obese subjects with metabolic syndrome .


Treatment induced changes in the [ ( 3 ) H ] - DHPG to [ ( 3 ) H ] - NE ratio related to reduction in hyperinsulinemia and improvements in diastolic function .


Persons living with HIV ( PLWH ) who also use crack cocaine may have stressful , chaotic lives and typically do not engage in standard medical care that addresses a multitude of extenuating life circumstances .


Yoga/meditation ( YM ) improves quality of life ( QOL ) and biomarkers of stress , but the effect of this intervention is almost unknown in PLWH , particularly those who use crack cocaine .


This pilot study sought to compare the feasibility and acceptability of 60-minute , twice-per-week sessions of YM for 2 months with those of no-contact control and to evaluate the effects of the intervention on QOL ( according to the Short Form-36 , Perceived Stress Scale [ PSS ] , and Impact of Events Scale [ IES ] ) and salivary cortisol and dehydroepiandrosterone sulfate ( DHEA-S ) among PLWH who use crack cocaine .


Participants were randomly assigned to YM or no-contact control and were assessed at baseline , 2 months after the intervention , and 4 months ' follow-up .


The YM program was acceptable and feasible , with high overall attendance ( 89 % ) and individual participation in yoga sessions ( 83 % ) .


YM participants showed modest improvements on QOL .


The PSS total score and the IES intrusion score improved significantly 2 months after the intervention , but cortisol and DHEA-S did not change .


This pilot study showed a high level of feasibility and acceptability and modest effects on measures of QOL among PLWH who use crack cocaine .


The results suggest utility of YM as a simple , safe , and inexpensive format to improve QOL in a population that has many medical difficulties and extenuating stressors .


The aim of the study was to compare prefeed abdominal circumference ( AC ) and gastric residual volume ( GRV ) as a measure of feed intolerance in very-low-birth-weight infants ( VLBW ) .


Eighty VLBW infants were randomized to 2 groups ; feed intolerance was monitored by measuring either GRV group or prefeed AC group .


The primary outcome was time to full enteral feeds ( 180 mL kg day ) .


Other main outcome measures were feed interruption days , duration of parenteral nutrition , incidence of culture positive sepsis , necrotizing enterocolitis , mortality , and duration of hospital stay .


The median ( interquartile range ) time to achieve full feeds was 10 ( 9-13 ) versus 14 ( 12-17 .5 ) days in AC and GRV groups , respectively ( P < 0.001 ) .


Infants in AC group had fewer feed interruption days ( 0 [ 0-2 ] vs 2.0 [ 1 , 5 ] , P < 0.001 ) and shorter duration of parenteral nutrition ( P < 0.001 ) .


The incidence of culture-positive sepsis in AC and GRV groups was 17.5 % and 30 % , respectively ( P = 0.18 ) .


Duration of hospital stay and mortality were comparable in both the groups .


Prefeed AC as a measure of feed intolerance in VLBW infants may shorten the time taken to achieve full feeds .


The Framingham risk score ( FRS ) is one of the standard tools used to predict the incidence of coronary heart disease ( CHD ) .


No previous study has investigated its efficacy for a Japanese population cohort .


The purpose of this study was to develop new coronary prediction algorithms for the Japanese population in the manner of the FRS , and to compare them with the original FRS .


Our coronary prediction algorithms for Japanese were based on a large population-based cohort study ( Suita study ) .


The study population comprised 5,521 healthy Japanese .


They were followed-up for 11.8 years on average , and 213 cases of CHD were observed .


Multiple Cox proportional hazard model by stepwise selection was used to construct the prediction model .


Our coronary prediction algorithms for Japanese patients were based on a large populationbased cohort study ( the Suita study ) .


A multiple Cox proportional hazard model by stepwise selection was used to construct the prediction model .


The C-statistics showed that the new model had better accuracy than the original and recalibrated Framingham scores .


The net reclassification improvement ( NRI ) by the Suita score with the inclusion of CKD was 41.2 % ( P0 .001 ) compared with the original FRS .


The recalibration of the FRS slightly improved the efficiency of the prediction , but it was still worse than the Suita score with the CKD model .


The calibration analysis suggested that the original FRS and the recalibrated FRS overestimated the risk of CHD in the Japanese population .


The Suita score with CKD more accurately predicted the risk of CHD .


The FRS and recalibrated FRS overestimated the 10-year risk of CHD for the Japanese population .


A predictive score including CKD as a coronary risk factor for the Japanese population was more accurate for predicting CHD than the original Framingham risk scores in terms of the C-statics and NRI .


The aim of our study was to evaluate the success rate of fiberoptic-guided endotracheal intubation through an Intubating Laryngeal Mask Airway ( ILMA ) , a Cobra Perilaryngeal Airway ( Cobra PLA ) , and a C-Trach Laryngeal Mask Airway ( C-Trach ) in patients whose necks are stabilized in a hard cervical collar .


One hundred and eighty ASA I-II patients were randomized to undergo endotracheal intubation after general anesthesia via an ILMA ( group ILMA ) , a C-Trach ( group C-Trach ) or a Cobra PLA ( group CPLA ) with the application of an appropriately-sized hard cervical collar .


A fiberoptic bronchoscope was used for intubation via the ILMA and Cobra PLA .


Rate of successful insertion of an endotracheal tube through the three devices was the primary aim .


Other parameters compared were time taken for device insertion , endotracheal intubation , hemodynamic changes , incidence of hypoxia , and mucosal injury during the procedure .


The incidence of postoperative sore throat was also compared between the three groups .


The success rates of intubation in the ILMA , C-Trach , and CPLA groups were 100 , 100 , and 98 % respectively .


The first-attempt success rate was significantly better with the C-Trach compared to Cobra PLA ( 100 vs. 85 % , p < 0.05 ) .


The time taken for device insertion was significantly more with the Cobra PLA as compared to that taken with an ILMA or a C-Trach ( 35.7 vs. 30.3 and 27.5 s , respectively ) .


Intubation through a C-Trach took the least amount of time ( 84.4 s ) as compared to an ILMA ( 117.9 s ) or a Cobra PLA ( 139.2 s ) .


The incidence of hypoxia and airway morbidity was similar between the groups .


The success rates of fiberoptic-guided endotracheal intubation through an ILMA and a Cobra PLA are similar to the success rate of intubation using a C-Trach in patients whose cervical spines are immobilized with a hard cervical collar .


To determine whether the sense of coherence ( SOC ) could predict the outcome of an 18-month lifestyle intervention program for subjects at risk of type 2 diabetes .


Subjects at high risk of type 2 diabetes mellitus were recruited to a low-intensity lifestyle intervention program by their general practitioners .


Weight reduction 5 % and improvement in exercise capacity of 10 % from baseline to follow-up indicated a clinically significant lifestyle change .


SOC was measured using the 13-item SOC questionnaire .


The study involved 213 subjects with a mean body mass index of 37 ( SD 6 ) .


Complete follow-up data were obtained for 131 ( 62 % ) .


Twenty-six participants had clinically significant lifestyle changes .


There was a 21 % increase in the odds of a clinically significant lifestyle change for each point increase in the baseline SOC score ( odds ratio = 1.21 ; confidence interval = 1.11-1 .32 ) .


The success rate was 14 times higher in the highest SOC score tertile group compared with the lowest .


High SOC scores were good predictors of successful lifestyle change in subjects at risk of type 2 diabetes .


SOC-13 can be used in daily practice to increase clinical awareness on the impact of mastery on the outcome of life-style intervention programs .


Teduglutide , a recombinant analog of human glucagon-like peptide ( GLP ) -2 , is a novel therapy recently approved for the treatment of adult patients with short bowel syndrome who are dependent on parenteral support .


Previous studies assessing the effect of GLP-2 on gastric emptying in humans have yielded inconsistent results , with some studies showing no effect and others documenting a GLP-2-dependent delay in gastric emptying .


The primary objective of this study was to assess the effect of teduglutide on gastric emptying of liquids in healthy subjects , as measured by the pharmacokinetics of acetaminophen .


This double-blind , parallel-group , single-center study enrolled and randomized 36 healthy subjects ( 22 men , 14 women ) to receive subcutaneous doses of teduglutide 4 mg or placebo ( 2:1 ratio ; 23:13 ) once daily on Days 1 through 10 in the morning .


Gastric emptying of a mixed nutrient liquid meal was assessed by measuring acetaminophen levels predose and at 0.25 , 0.5 , 0.75 , 1 , 1.25 , 1.5 , 2 , 3 , 3.5 , 4 , 5 , 6 , 8 , 10 , 12 , and 14 hours after administration of 1000 mg acetaminophen on Days 0 and 10 .


The primary study endpoint was a pharmacokinetic analysis of acetaminophen absorption in subjects receiving teduglutide or placebo .


No significant differences in gastric emptying of liquids ( acetaminophen area under the concentration [ AUC ] vs time curve from time 0 to the last measurable concentration , AUC extrapolated to infinity , maximum concentration [ Cmax ] , and time to Cmax ) were observed on Day 10 in subjects receiving teduglutide 4 mg versus subjects receiving placebo .


There were no serious adverse events ( AEs ) , deaths , or discontinuations due to an AE reported during the study .


Teduglutide 4 mg/day for 10 days does not affect gastric emptying of liquids in healthy subjects as measured by acetaminophen pharmacokinetics .


No unexpected safety signals were observed .


This study was registered at ClinicalTrials.gov , identifier NCT01209351 .


Asian Americans have the highest incidence of hepatocellular carcinoma ( HCC ) , the major form of primary liver cancer , of all ethnic groups in the United States .


Chronic hepatitis B virus ( HBV ) infection is the most common cause of HCC , and as many as 1 in 10 foreign-born Asian Americans are chronically infected with HBV .


We tested the effectiveness of a culturally tailored liver cancer education program for increasing screening for HBV among Chinese , Korean , and Vietnamese Americans residing in the Baltimore-Washington metropolitan area , from November 2009 through June 2010 .


We used a cluster randomized controlled trial to recruit volunteer participants from community-based organizations ( CBOs ) in the Baltimore-Washington metropolitan area .


We selected 877 participants by using a pretest survey .


People were eligible to participate if they had not attended a hepatitis B-related education program in the past 5 years .


The intervention group ( n = 441 ) received a 30-minute educational program , and the control group ( n = 436 ) received an educational brochure .


After attending the educational program , the intervention group completed a post-education survey .


Six months later , participants in both groups were followed up by telephone .


Receipt of HBV screening was the outcome measure .


Approximately 79 % ( n = 688 ) of participants completed the 6-month follow-up telephone survey .


Among those who had not had HBV screening at baseline ( n = 446 ) , the adjusted odds of self-reported receipt of HBV screening at the 6-month follow-up to the educational program were significantly higher for the intervention group than for the control group ( odds ratio = 5.13 ; 95 % confidence interval , 3.14-8 .39 ; P < .001 ) .


Chinese Americans and Vietnamese Americans had significantly higher odds of having HBV screening in the 6-month period than Korean Americans .


Culturally tailored education programs that increase liver cancer awareness can be effective in increasing HBV screening among underserved Asian American populations .


Placental extract has been used as a therapeutic agent with application in various fields of medicine .


Placental extract is well known for its effects on wound healing with anti-inflammatory , antiplatelet , and angiogenic effects and is also a biogenic modulator .


The present study evaluated the effect of placental extract on wound healing , mouth opening , and postoperative patient discomfort in patients with oral submucous fibrosis treated with fibrotomy with buccal fat pad coverage and coronoidectomy .


Ten subjects with oral submucous fibrosis who presented with mouth opening less than 20 mm were enrolled in the present prospective randomized controlled trial to assess the effects of placental extract on the fibrotomy wound covered with a pedicled buccal pad fat ( 5 patients allocated to the study group , group S and 5 to the control group , group C ) .


The following criteria were used to analyze the postoperative effect of placental extract on fibrotomy wounds compared with that of the controls : subjective assessment of the wound , postoperative discomfort , and postoperative mouth opening assessed at 1 , 2 , and 4 weeks postoperatively .


The average difference in the preoperative and fourth week postoperative mouth opening for group C was 13.8 2.68 mm and was 21.20 2.77 mm in group S.


The median calculated for group C was a 15.0-mm increase in mouth opening and was 20.0 mm in group S.


The results obtained with topical application of placental extract on fibrotomy wound healing and postoperative mouth opening were superior to those of the control group in whom placental extract was not used .


To investigate the safety of minimal immunosuppression ( IS ) in liver transplantation ( LT ) .


The lack of long-term follow-up studies , including pathologic data , has led to a protean handling of IS in LT.


Between February 2000 and September 2004 , 156 adults were enrolled in a prospective , randomized , double-blind , placebo-controlled minimization trial comparing tacrolimus placebo ( TAC-PLAC ) and TAC short-term steroid ( TAC-STER ) IS .


All patients had a minimum clinical , biochemical , and histological follow-up of 5 years .


Five-year actual patient and graft survival rates in TAC-PLAC and TAC-STER groups were 78.1 % and 82.1 % ( P = 0.89 ) and 74.2 % and 76.9 % ( P = 0.90 ) , respectively .


Five-year biopsies were available in 112 ( 89.6 % ) of 125 survivors .


Twelve patients refused a biopsy because of their excellent evolution ; tissue material was insufficient in 1 patient ; 11 had normal liver tests ; and 2 patients had developed alcoholic and secondary biliary cirrhosis .


Histology was normal in 44 ( 39.3 % ) patients ; 35 ( 31.3 % ) had disease recurrence .


The remaining biopsies showed nonspecific chronic hepatitis ( 14.3 % ) , mild inflammatory infiltrates ( 10.7 % ) , and steatosis ( 3.5 % ) .


All findings were equally distributed between both groups .


In each group , 3 patients ( 4.8 % ) presented with acute cellular rejection after the first year and only 1 ( 0.9 % ) TAC-PLAC patient developed chronic rejection after IS withdrawal because of pneumonitis .


Arterial hypertension , diabetes mellitus , renal insufficiency , hypercholesterolemia , gout , and obesity were equally low in both groups .


Excellent long-term results can be obtained under minimal IS and absence of steroids .


TAC-based monotherapy is feasible in most adult liver recipients until 5 years of follow-up .


To evaluate the effects of combining the assessment of circulating high-sensitivity C-reactive protein ( hs-CRP ) with that of Epstein-Barr virus DNA ( EBV DNA ) in the pretherapy prognostication of nasopharyngeal carcinoma ( NPC ) .


Three independent cohorts of NPC patients ( training set of n = 3113 , internal validation set of n = 1556 , and prospective validation set of n = 1668 ) were studied .


Determinants of disease-free survival , distant metastasis-free survival , and overall survival were assessed by multivariate analysis .


Hazard ratios and survival probabilities of the patient groups , segregated by clinical stage ( T1-2N0-1M0 , T3-4N0-1M0 , T1-2N2-3M0 , and T3-4N2-3M0 ) and EBV DNA load ( low or high ) alone , and also according to hs-CRP level ( low or high ) , were compared .


Elevated hs-CRP and EBV DNA levels were significantly correlated with poor disease-free survival , distant metastasis-free survival , and overall survival in both the training and validation sets .


Associations were similar and remained significant after excluding patients with cardiovascular disease , diabetes , and chronic hepatitis B. Patients with advanced-stage disease were segregated by high EBV DNA levels and high hs-CRP level into a poorest-risk group , and participants with either high EBV DNA but low hs-CRP level or high hs-CRP but low EBV DNA values had poorer survival compared with the bottom values for both biomarkers .


These findings demonstrate a significant improvement in the prognostic ability of conventional advanced NPC staging .


Baseline plasma EBV DNA and serum hs-CRP levels were significantly correlated with survival in NPC patients .


The combined interpretation of EBV DNA with hs-CRP levels led to refinement of the risks for the patient subsets , with improved risk discrimination in patients with advanced-stage disease .


Nerve growth factor ( NGF ) is a neurotrophin with therapeutic possibilities that extend from the nervous system to the eye .


We tested the safety , maximal tolerated dose , pharmacokinetics , and antigenicity of a novel human recombinant NGF ( rhNGF ) eye-drop formulation in a phase I study .


This prospective , randomized , double-masked , vehicle-controlled trial , sponsored by Domp SpA ( registered as NCT01744704 at ClinicalTrials.gov ) , enrolled 74 healthy volunteers ( 24 females , 50 males , age 40.211.8 years ) .


Subjects were randomized in three cohorts to receive ( 1 ) a single eye-drop containing 0.0175 , 0.175 , or 0.7 g rhNGF ; ( 2 ) a single ascending dose of rhNGF eye drops three times a day for 1day ( total daily dose 2.1 , 6.3 , or 18.9 g ) , or vehicle ; or ( 3 ) a multiple ascending dose of rhNGF eye drops three times a day for 5days ( total dose 10.5 , 31.5 , or 94.5 g ) , or vehicle .


Outcome measures included blood chemistry , urinalyses , vital signs , electrocardiograms ( ECGs ) , serum NGF antibodies , ocular and systemic adverse events ( AEs ) , visual acuity , tear function , intraocular pressure , fundus oculi , and ocular symptoms .


Administration of rhNGF eye drops did not result in a significant increase of circulating NGF levels and no antidrug antibodies were detected in serum .


No serious AEs were recorded , and a few mild , transient ocular AEs related to rhNGF administration were reported only at the highest concentration .


rhNGF eye drops were well tolerated , with no detectable clinical evidence of systemic AEs .


These results pave the way for the development of clinical trials on rhNGF in ophthalmology .


The impact of intraoperative hydrodebrider sinus irrigation ( HSI ) during endoscopic sinus surgery ( ESS ) on postoperative inflammation , endoscopy , and patient-reported outcomes has not been studied .


A clinical trial of 12 patients with symmetric chronic rhinosinusitis were prospectively randomized to HSI on one side after undergoing bilateral ESS .


The contralateral side was not treated with any irrigation and served as an internal control .


Preoperative computed tomography , endoscopic , 22-item Sino-Nasal Outcome Test ( SNOT-22 ) , and symptom visual analog scale ( VAS ) scores for each side were obtained .


At 1 and 3 months postsurgery , endoscopy , SNOT-22 , and sinus VAS were recorded .


Sinonasal mucus levels of interleukin ( IL ) -6 , IL-10 , IL-17a , and tumor necrosis factor ( TNF ) alpha were measured at the time of surgery , 1 and 3 months , postoperatively , from each side .


VAS scores improved on both sides ( p < 0.05 ) and SNOT-22 improved at all postoperative time points ( p < 0.05 ) .


Endoscopic scores of HSI-treated sides did not improve compared with baseline .


HSI had no additional significant impact on postoperative VAS at any time point .


HSI significantly decreased IL-17a levels when compared with the control side at 1 month ( p = 0.034 ) and 3 months ( p = 0.031 ) .


No significant change was seen in TNF-alpha , IL-6 , or IL-10 on either side at any time point .


Intraoperative HSI at the time of ESS failed to establish any improvement in postoperative endoscopy or most local cytokine levels after ESS .


This study examined whether changes in pH throughout the physiologic range would have a differential effect on central and peripheral factors associated with fatigue and force production during submaximal lower limb isometric exercise to task failure .


Eight males completed three experimental trials [ 0.2 g kg ( -1 ) ammonia chloride ( ACD ) ; 0.3 g kg ( -1 ) calcium carbonate ( PLA ) ; or 0.3 g kg ( -1 ) sodium bicarbonate ( ALK ) ] , each consisting of submaximal calf contractions at 55 % of maximal voluntary contraction ( MVC ) to task failure .


Every minute of the task subjects performed an MVC , coupled with stimulation of the tibial nerve during and immediately post MVC .


Time to task failure was not different between trials ( ACD 531 166 s , PLA 592 163 s , ALK 596 150 s ; p = 0.31 ) .


MVC force in all trials declined 29 % from the start of exercise to the fifth minute ( mean decline of 371 26 N ; p < 0.001 ) , however was not different between trials ( p = 0.21 ) .


Fatigue was mediated in all trials by central and peripheral factors , as declines in voluntary activation , V/M-wave in the soleus and the potentiated resting twitch amplitudes were evident throughout the task ( p < 0.05 ) .


Central fatigue appeared to be muscle specific , as reductions in central drive ( V/M-wave and rate of sEMG rise ) persisted in the soleus but not the medial gastrocnemius .


These data suggest that calf fatigue associated with intermittent , isometric contractions to task failure is unaffected by alterations in pH ; however , central drive reductions may be muscle specific .


We aimed to assess the efficacy and safety of sequential or simultaneous telomerase vaccination ( GV1001 ) in combination with chemotherapy in patients with locally advanced or metastatic pancreatic cancer .


TeloVac was a three-group , open-label , randomised phase 3 trial .


We recruited patients from 51 UK hospitals .


Eligible patients were treatment naive , aged older than 18 years , with locally advanced or metastatic pancreatic ductal adenocarcinoma , and Eastern Cooperative Oncology Group performance status of 0-2 .


Patients were randomly assigned ( 1:1:1 ) to receive either chemotherapy alone , chemotherapy with sequential GV1001 ( sequential chemoimmunotherapy ) , or chemotherapy with concurrent GV1001 ( concurrent chemoimmunotherapy ) .


Treatments were allocated with equal probability by means of computer-generated random permuted blocks of sizes 3 and 6 in equal proportion .


Chemotherapy included six cycles of gemcitabine ( 1000 mg/m ( 2 ) , 30 min intravenous infusion , at days 1 , 8 , and 15 ) and capecitabine ( 830 mg/m ( 2 ) orally twice daily for 21 days , repeated every 28 days ) .


Sequential chemoimmunotherapy included two cycles of combination chemotherapy , then an intradermal lower abdominal injection of granulocyte-macrophage colony-stimulating factor ( GM-CSF ; 75 g ) and GV1001 ( 056 mg ; days 1 , 3 , and 5 , once on weeks 2-4 , and six monthly thereafter ) .


Concurrent chemoimmunotherapy included giving GV1001 from the start of chemotherapy with GM-CSF as an adjuvant .


The primary endpoint was overall survival ; analysis was by intention to treat .


This study is registered as an International Standard Randomised Controlled Trial , number ISRCTN4382138 .


The first patient was randomly assigned to treatment on March 29 , 2007 , and the trial was terminated on March 27 , 2011 .


Of 1572 patients screened , 1062 were randomly assigned to treatment ( 358 patients were allocated to the chemotherapy group , 350 to the sequential chemoimmunotherapy group , and 354 to the concurrent chemoimmunotherapy group ) .


We recorded 772 deaths ; the 290 patients still alive were followed up for a median of 60 months ( IQR 24-122 ) .


Median overall survival was not significantly different in the chemotherapy group than in the sequential chemoimmunotherapy group ( 79 months [ 95 % CI 71-88 ] vs 69 months [ 64-76 ] ; hazard ratio [ HR ] 119 , 9825 % CI 097-148 , p = 005 ) , or in the concurrent chemoimmunotherapy group ( 84 months [ 95 % CI 73-97 ] , HR 105 , 9825 % CI 085-129 , p = 064 ; overall log-rank of ( 2 ) 2df = 43 ; p = 011 ) .


The commonest grade 3-4 toxic effects were neutropenia ( 68 [ 19 % ] patients in the chemotherapy group , 58 [ 17 % ] patients in the sequential chemoimmunotherapy group , and 79 [ 22 % ] patients in the concurrent chemoimmunotherapy group ; fatigue ( 27 [ 8 % ] in the chemotherapy group , 35 [ 10 % ] in the sequential chemoimmunotherapy group , and 44 [ 12 % ] in the concurrent chemoimmunotherapy group ) ; and pain ( 34 [ 9 % ] patients in the chemotherapy group , 39 [ 11 % ] in the sequential chemoimmunotherapy group , and 41 [ 12 % ] in the concurrent chemoimmunotherapy group ) .


Adding GV1001 vaccination to chemotherapy did not improve overall survival .


New strategies to enhance the immune response effect of telomerase vaccination during chemotherapy are required for clinical efficacy .


Cancer Research UK and KAEL-GemVax .


MicroRNAs ( miRNAs ) regulate genes in animals and plants and can be synthesized endogenously .


In milk , miRNAs are encapsulated in exosomes , thereby conferring protection against degradation and facilitating uptake by endocytosis .


The majority of bovine miRNAs have nucleotide sequences complementary to human gene transcripts , suggesting that miRNAs in milk might regulate human genes .


We tested the hypotheses that humans absorb biologically meaningful amounts of miRNAs from nutritionally relevant doses of milk , milk-borne miRNAs regulate human gene expression , and mammals can not compensate for dietary miRNA depletion by endogenous miRNA synthesis .


Healthy adults ( 3 men , 2 women ; aged 26-49 y ) consumed 0.25 , 0.5 , and 1.0 L of milk in a randomized crossover design .


Gene expression studies and milk miRNA depletion studies were conducted in human cell cultures and mice , respectively .


For comparison , feeding studies with plant miRNAs from broccoli were conducted in humans .


Postprandial concentration time curves suggest that meaningful amounts of miRNA ( miR ) -29 b and miR-200c were absorbed ; plasma concentrations of miR-1 did not change ( negative control ) .


The expression of runt-related transcription factor 2 ( RUNX2 ) , a known target of miR-29b , increased by 31 % in blood mononuclear cells after milk consumption compared with baseline .


When milk exosomes were added to cell culture media , mimicking postprandial concentrations of miR-29b and miR-200c , reporter gene activities significantly decreased by 44 % and 17 % , respectively , compared with vehicle controls in human embryonic kidney 293 cells .


When C57BL/6J mice were fed a milk miRNA-depleted diet for 4 wk , plasma miR-29b concentrations were significantly decreased by 61 % compared with miRNA-sufficient controls , i.e. , endogenous synthesis did not compensate for dietary depletion .


Broccoli sprout feeding studies were conducted as a control and elicited no detectable increase in Brassica-specific miRNAs .


We conclude that miRNAs in milk are bioactive food compounds that regulate human genes .


Cigarette craving usually occurs in conjunction with unpleasant feelings , including stress , as part of a withdrawal syndrome .


Progressive muscle relaxation ( PMR ) , a behavioral technique used to reduce stress by concentrating on achieving muscle relaxation , may reduce levels of cigarette craving and other substance-related negative feelings and withdrawal symptoms .


Demographic and cigarette use data were collected from 32 experienced smokers at the King Chulalongkorn Memorial Hospital , Bangkok , Thailand using the Semi-Structured Assessment for Drug Dependence and Alcoholism .


Participants were asked to refrain from smoking for at least 3 hours before the visit ( acute abstinence ) and were randomly allocated to a 1-session PMR group ( n = 16 ) or a control activity group ( e.g. , reading newspaper , n = 16 ) .


The intervention group was instructed to practice PMR individually in a quiet , private , air-conditioned room for about 20minutes .


Craving , other substance-related feelings , and autonomic nervous responses ( e.g. , blood pressure and pulse rate ) were assessed immediately before and after the 1-session intervention .


There were no differences in demographics , cigarette use/dependence , and baseline craving characteristics between the PMR and control groups .


However , the control group had higher levels of high and paranoia feeling , and pulse rate than the PMR group at baseline .


After practicing PMR , but not after a control activity , smokers undergoing acute abstinence had significantly lower levels of cigarette craving , withdrawal symptoms , and systolic blood pressure than at baseline .


After controlling for baseline differences , abstaining smokers using PMR had lower levels of cigarette craving , withdrawal symptoms , and systolic blood pressure than smokers who undertook a control activity .


PMR significantly reduces cigarette craving , withdrawal symptoms , and blood pressure in smokers undergoing acute abstinence .


PMR may be used as an adjunct to cigarette dependency treatments .


Inoperable aortic stenosis may be treated with either transcatheter aortic valve replacement ( TAVR ) or medical management ( MM ) with or without balloon aortic valvuloplasty ( BAV ) .


The aim of this study was to compare the long-term echocardiographic findings among TAVR , MM , and BAV in patients with severe , inoperable aortic stenosis .


A total of 358 inoperable patients in the Placement of Aortic Transcatheter Valves trial were randomized to MM or TAVR .


Echocardiograms obtained at baseline , 30 days , and 1 , 2 , and 3 years were analyzed by a central core laboratory .


At baseline , TAVR and MM were similar , with more frequent Society of Thoracic Surgeons score > 10 ( 51.7 % vs 65.0 % , P = .03 ) and larger end-systolic volumes ( 54.5 29.3 vs 69.1 48.0 mL , P = .03 ) in MM .


By 30 days after TAVR , mean aortic valve gradient had decreased ( from 43.8 14.7 to 10.0 4.3 mm Hg , P < .001 ) , ejection fraction had increased ( from 53.2 12.4 % to 56.7 10.0 % , P < .001 ) , and left ventricular ( LV ) mass index had decreased ( from 144.7 36.1 to 140.0 37.9 gm/m ( 2 ) , P < .05 ) .


After 1 year , aortic valve gradients and area were unchanged , while LV mass index had decreased by another 16 gm/m ( 2 ) ( to 124 gm/m ( 2 ) ) .


By 30 days after BAV , mean aortic valve gradient had decreased from 43.4 15.0 to 31.9 11.1 mm Hg , while ejection fraction and LV mass index were unchanged ; gradient reverted to baseline at 1 year .


No changes in gradients or mass were seen in MM patients .


TAVR results in immediate and sustained relief in pressure overload and improved LV systolic function , with continued regression of hypertrophy over 3 years .


Poor clinical results with BAV are explained by the modest and transient reductions in pressure overload with BAV , which were not accompanied by improved LV function or remodeling .


TAVR is the preferred treatment in eligible inoperable patients ( ClinicalTrials.gov identifier NCT00530894 ) .


Statins are the most commonly prescribed drugs to reduce cardiometabolic risk .


Besides the well-known efficacy of such compounds in both preventing and treating cardiometabolic disorders , some patients experience statin-induced side effects .


We hypothesize that the use of natural bergamot-derived polyphenols may allow patients undergoing statin treatment to reduce effective doses while achieving target lipid values .


The aim of the present study is to investigate the occurrence of an enhanced effect of bergamot-derived polyphenolic fraction ( BPF ) on rosuvastatin-induced hypolipidemic and vasoprotective response in patients with mixed hyperlipidemia .


A prospective , open-label , parallel group , placebo-controlled study on 77 patients with elevated serum LDL-C and triglycerides was designed .


Patients were randomly assigned to a control group receiving placebo ( n = 15 ) , two groups receiving orally administered rosuvastatin ( 10 and 20mg/daily for 30 days ; n = 16 for each group ) , a group receiving BPF alone orally ( 1000 mg/daily for 30 days ; n = 15 ) and a group receiving BPF ( 1000 mg/daily given orally ) plus rosuvastatin ( 10mg/daily for 30 days ; n = 15 ) .


Both doses of rosuvastatin and BPF reduced total cholesterol , LDL-C , the LDL-C/HDL-C ratio and urinary mevalonate in hyperlipidemic patients , compared to control group .


The cholesterol lowering effect was accompanied by reductions of malondialdehyde , oxyLDL receptor LOX-1 and phosphoPKB , which are all biomarkers of oxidative vascular damage , in peripheral polymorphonuclear cells .


Addition of BPF to rosuvastatin significantly enhanced rosuvastatin-induced effect on serum lipemic profile compared to rosuvastatin alone .


This lipid-lowering effect was associated with significant reductions of biomarkers used for detecting oxidative vascular damage , suggesting a multi-action enhanced potential for BPF in patients on statin therapy .


Patients undergoing surgery in the beach chair position ( BCP ) are at a risk of cerebral ischemia .


We evaluated the effect of arginine vasopressin ( AVP ) on hemodynamics and cerebral oxygenation during surgery in the BCP .


Thirty patients undergoing shoulder surgery in BCP under propofol-remifentanil anesthesia were randomly allocated either to receive IV AVP 0.07 U/kg ( AVP group , N = 15 ) or an equal volume of saline ( control group , N = 15 ) 2 minutes before taking BCP .


Mean arterial blood pressure ( MAP ) , heart rate ( HR ) , jugular venous bulb oxygen saturation ( SjvO2 ) , and regional cerebral tissue oxygen saturation ( SctO2 ) were measured after induction of anesthesia and before ( presitting in supine position ) and after patients took BCP .


AVP itself given before the positioning increased MAP and decreased SjvO2 and SctO2 ( P < 0.0001 ) , with HR unaffected .


Although MAP was decreased by BCP in both groups , it was higher in the AVP group ( P < 0.0001 ) .


While in BCP , HR remained unaltered in the control and decreased in the AVP group .


SjvO2 in BCP did not differ between the groups .


SctO2 was decreased by BCP in both groups , which was more pronounced in the AVP group until the end of study .


The incidence of hypotension ( 13 % vs 67 % ; P = 0.003 ) was less frequent , and that of cerebral desaturation ( > 20 % SctO2 decrease from presitting value ) ( 80 % vs 13 % ; P = 0.0003 ) was higher in the AVP group .


The incidence of jugular desaturation ( SjvO2 < 50 % ) was comparable between the groups .


A prophylactic bolus administration of AVP prevents hypotension associated with BCP in patients undergoing shoulder surgery under general anesthesia .


However , it was associated with regional cerebral but not jugular venous oxygen desaturation on upright positioning .


To explore the feasibility , safety , efficacy , and cosmetic outcomes of transvaginal endoscopic salpingectomy for tubal ectopic pregnancy .


From May 2009 to May 2012 , we prospectively enrolled 40 patients , each of whom had been scheduled for a salpingectomy because of a tubal ectopic pregnancy , and randomized them into two groups : transvaginal endoscopic surgery and laparoscopic approach .


We recorded the estimated blood loss , time of anal exhaust , postoperative pain score , length of stay , and scar assessment scale associated with transvaginal endoscopic access ( n = 18 ) ( natural orifice transluminal endoscopic surgery ) and laparoscopic salpingectomy ( n = 20 ) ( control group ) for tubal ectopic pregnancy .


The transvaginal salpingectomy was performed with a double-channel endoscope through a vaginal puncture .


A single surgeon performed the surgical procedures in patients in both groups .


The group that underwent the transvaginal endoscopic procedure reported lesser pain at all postoperative visits than the group that underwent the laparoscopic approach .


The duration of time for transvaginal endoscopic surgery was slightly longer than that for the laparoscopic approach .


However , there was no statistically significant difference between the two groups in the duration of operative time .


The group that underwent transvaginal endoscopic surgery was more satisfied with the absence of an external scar than the group that underwent the laparoscopic procedure , which left a scar .


The estimated blood loss , time of anal exhaust , and length of stay were the same in both groups .


The safety and efficacy of transvaginal endoscopic salpingectomy for tubal ectopic pregnancy are equivalent to those of the laparoscopic procedure .


Lesser postoperative pain and a more satisfactory cosmetic outcome were found with the transvaginal endoscopic procedure , making it the more preferred method and superior to the laparoscopic approach .


Acute pancreatitis has a highly variable clinical course .


Early and reliable predictors for the severity of acute pancreatitis are lacking .


Proteinuria appears to be a useful predictor of disease severity and outcome in a variety of clinical conditions .


This study aims to investigate the predictive value of proteinuria on admission for the severity of acute pancreatitis compared with other commonly used predictors ; the APACHE II score , Modified Glasgow score and C-reactive protein ( CRP ) .


This is a post-hoc analysis of 64 patients admitted with acute pancreatitis treated in one teaching hospital , who participated in a previous randomized trial .


Proteinuria was defined as a Protein/Creatinine ( P/C ) ratio > 23 mg/mmol .


The primary endpoint was severe acute pancreatitis .


Secondary endpoints included infectious complications , need for invasive intervention , ICU stay and in-hospital mortality .


Proteinuria was present in 30/64 patients ( 47 % ) .


Eleven patients ( 17 % ) had severe acute pancreatitis .


There was no difference in incidence of severe acute pancreatitis between patients with and without proteinuria : 6/30 patients ( 20 % ) versus 5/34 patients ( 15 % ) respectively ( p = 0.58 ) .


Likewise , the occurrence of infectious complications , need for intervention and ICU stay and mortality did not differ significantly ( p = 0.58 , p = 0.99 , p = 0.33 and p = 0.60 respectively ) .


The diagnostic performance of the P/C ratio for the prediction of severe pancreatitis was inferior to the Modified Glasgow score ( p = 0.04 ) and CRP ( p = 0.03 ) .


Proteinuria on admission does not seem to be a reliable predictor for disease severity in acute pancreatitis .


The diagnostic performance of the P/C ratio is inferior to the Modified Glasgow score and CRP .


To compare the use of magnesium sulfate for 12 hours versus 24 hours in postpartum women with stable severe pre-eclampsia .


In 2011 , an open randomized clinical trial was conducted with 120 postpartum women with severe pre-eclampsia who gave birth at a tertiary hospital in Brazil ; 60 women received magnesium sulfate for 24 hours and 60 for 12 hours .


The analysis was by intention-to-treat and the intervention was not masked .


Abbreviated ( 12-hour ) magnesium sulfate therapy was associated with less exposure to the drug , and clinical outcomes were similar in both groups .


No woman developed eclampsia and there was no need to re-initiate treatment after completing the scheduled magnesium sulfate therapy in either group .


Magnesium sulfate therapy was extended in only three women in the 12-hour group .


In addition , in this group , significant reductions were found in the duration of postpartum use of an indwelling bladder catheter , the time to ambulation , and the time to maternal contact with the newborn .


Abbreviated postpartum magnesium sulfate therapy in patients with stable severe pre-eclampsia was associated with less drug exposure , similar outcomes , and benefits such as a reduction in the time to contact with the newborn .


clinicaltrials.gov NCT1408979 .


Persistent facial erythema is the most common primary pathological feature of rosacea , the only treatment for which is brimonidine tartrate ( BT ) gel .


To assess the relative bioavailability of topical BT gel in comparison with the ophthalmic BT solution .


A pharmacokinetic study was conducted to compare intraindividual systemic exposures after dermal application of BT gel ( 007 % , 018 % and 05 % ) under maximal use conditions in patients with moderate-to-severe facial erythema associated with rosacea , and administration of BT ophthalmic solution 02 % .


Patients who received BT ophthalmic solution 02 % three times a day for 1 day had a mean Cmax of 54 28 pg mL ( -1 ) and a mean 0-24-h area under the curve ( AUC0-24 h ) of 568 277 pg h mL ( -1 ) .


Topical application of BT gel for 29 days resulted in quantifiable systemic exposure in 22 % , 48 % , 71 % and 79 % of patients who received BT gel 007 % twice daily , 018 % once daily , 018 % twice daily and 05 % once daily , respectively .


The mean Cmax values for the BT gels ranged between 13 and 25 pg mL ( -1 ) , and mean AUC0-24 h values ranged between 42 and 290 pg h mL ( -1 ) .


Systemic exposure increased with applied dose , with no drug accumulation for the duration of treatment .


The systemic exposure observed with the highest dose of BT gel ( 05 % once daily ) was significantly lower than the systemic levels observed for the ophthalmic solution .


02 % apply for all the concentrations .


The systemic safety profile of BT gel may be considered better than that of the ophthalmic solution .


Transoral incisionless fundoplication ( TIF ) was developed in an attempt to create a minimally invasive endoscopic procedure that mimics antireflux surgery .


The objective of this trial was to evaluate effectiveness of TIF compared with proton pump inhibition in a population consisting of gastroesophageal reflux disease ( GERD ) patients controlled with proton pump inhibitors ( PPIs ) who opted for an endoscopic intervention over lifelong drug dependence .


Patients with chronic GERD were randomized ( 2:1 ) for TIF or continuation of PPI therapy .


American Society of Anesthesiologists > 2 , body mass index > 35kg/m ( 2 ) , hiatal hernia > 2cm , and esophageal motility disorders were exclusion criteria .


Primary outcome measure was GERD-related quality of life .


Secondary outcome measures were esophageal acid exposure , number of reflux episodes , PPI usage , appearance of the gastroesophageal valve , and healing of reflux esophagitis .


Crossover for the PPI group was allowed after 6 months .


A total of 60 patients ( TIF n = 40 , PPI n = 20 , mean body mass index 26kg/m ( 2 ) , 37 male ) were included .


At 6 months , GERD symptoms were more improved in the TIF group compared with the PPI group ( P < 0.001 ) , with a similar improvement of distal esophageal acid exposure ( P = 0.228 ) compared with baseline .


The pH normalization for TIF group and PPI group was 50 % and 63 % , respectively .


All patients allocated for PPI treatment opted for crossover .


At 12 months , quality of life remained improved after TIF compared with baseline ( P < 0.05 ) , but no improvement in esophageal acid exposure compared with baseline was found ( P = 0.171 ) and normalization of pH was accomplished in only 29 % in conjunction with deteriorated valve appearances at endoscopy and resumption of PPIs in 61 % .


Although TIF resulted in an improved GERD-related quality of life and produced a short-term improvement of the antireflux barrier in a selected group of GERD patients , no long-term objective reflux control was achieved .


The aim was to investigate the effect of skin contact between mother and child in pain relief of full-term newborns during heel blood collection .


The authors randomly divided 40 full-term newborns into two groups .


In the experimental group , the newborn received kangaroo care from the mother before , during , and after the 20-minute heel blood collection .


In the control group , the heel blood collection was performed under conventional conditions .


The authors compared the two groups ' heart rate , oxygen saturation , facial expressions of pain , and duration of crying .


The two groups had no statistically significant difference in terms of gender , birth weight , mode of delivery , and gestational age ( p > 0.05 ) .


In the seven time periods during the puncture after ten seconds from the beginning and ten seconds after the end , the neonatal heart rates of the two groups changed and statistically significant differences were observed in the duration of heel blood collection , interaction and group factors , as well as in oxygen saturation ( p < 0.01 ) .


During heel blood collection , skin contact between the mother and child can relieve pain , reduce changes in heart rate , improve neonatal heel blood oxygen saturation , and enhance the emotional communication between the mother and child .


To investigate the effects of a suicide prevention programme on the levels of depression , self-esteem , suicidal ideation and spirituality in patients with mental illness .


Instances of suicide have significant correlations with depression , low self-esteem , suicidal ideation and a low level of spirituality in the victims .


Therefore , addressing depression , low self-esteem and suicidal ideation as suicide risk factors and increasing levels of spirituality can constitute an effective programme to prevent suicide among patients with mental illness .


The study was a quasi-experimental study with a nonequivalent control group , nonsynchronised design .


The study sample consisted of 45 patients with mental illness who had been admitted to the psychiatric unit in a university hospital in South Korea .


The patients were assigned to control and experimental groups of 23 and 22 members , respectively .


The suicide prevention programme was conducted with the experimental group over four weeks and included eight sessions ( two per week ) .


The control group received only routine treatments in the hospital .


The experimental group that participated in the programme had significantly decreased mean scores for depression and suicidal ideation compared with the control group .


However , there were no significant differences in the mean scores for self-esteem and spirituality between the groups .


The suicide prevention programme might be usefully applied as a nursing intervention for patients hospitalised in psychiatric wards or clinics where the goals are to decrease depression and suicidal ideation .


Typical treatments for hospitalised patients with mental illness are not enough to prevent suicide .


Intervention for suicide prevention needs to apply an integrated approach .


The suicide prevention programme using an integrated approach is more effective in reducing depression and suicidal ideation in patients with mental illness than applying routine treatments in the hospital .


This study aims for health gain and cost reduction in the care for people with long-term non-psychotic psychiatric disorders .


Present care for this population has a limited evidence base , is often open ended , little effective , and expensive .


Recent epidemiological data shows that 43.5 % of the Dutch are affected by mental illness during their life .


About 80 % of all patients receiving mental health services ( MHS ) have one or more non-psychotic disorders .


Particularly for this group , long-term treatment and care is poorly developed .


Care As Usual ( CAU ) currently is a form of low-structured treatment/care .


Interpersonal Community Psychiatric Treatment ( ICPT ) is a structured treatment for people with long-term , non-psychotic disorders , developed together with patients , professionals , and experts .


ICPT uses a number of evidence-based techniques and was positively evaluated in a controlled pilot study .


Multi-centre cluster-randomized clinical trial : 36 professionals will be randomly allocated to either ICPT or CAU for an intervention period of 12months , and a follow-up of 6months .


180 Patients between 18-65 years of age will be included , who have been diagnosed with a non-psychotic psychiatric disorder ( depressive , anxiety , personality or substance abuse disorder ) , have long-term ( > 2years ) or high care use ( > 1 outpatient contact per week or > 2 crisis contacts per year or > 1 inpatient admission per year ) , and who receive treatment in a specialized mental health care setting .


The primary outcome variable is quality of life ; secondary outcomes are costs , recovery , general mental health , therapeutic alliance , professional-perceived difficulty of patient , care needs and social contacts .


No RCT , nor cost-effectiveness study , has been conducted on ICPT so far .


The empirical base for current CAU is weak , if not absent .


This study will fill this void , and generate data needed to improve daily mental health care .


Netherlands Trial Register ( NTR ) : 3988 .


Registered 13th of May 2013 .


Intraabdominal hypertension is a common occurrence , especially in intensive care unit patients , and it has high mortality and morbidity rates .


The onset is commonly insidious and the poor prognosis is attributed to the long delay in diagnosis .


Unfortunately , diagnosis is often delayed until loss of function in the affected tissues has already occurred .


The aim of this study was to determine the predictive value of mean platelet volume ( MPV ) in assessing the risk of intraabdominal hypertension .


Pneumoperitoneum during elective laparoscopic cholecystectomy was used as a model for intraabdominal hypertension .


The study included 103 patients who met the inclusion criteria .


MPV evaluations were made at 3 distinct times during laparoscopic cholecystectomy based on the actual intraabdominal pressure .


MPV values during preinsufflation , insufflation , and desufflation were 8.483 fL ( range : 6.7 to 11.1 ) , 8.901 fL ( range : 6.8 to 11.9 ) , and 8.538 fl ( range : 5.8 to 10.9 ) , respectively .


A statistically significant increase in MPV values was found during high intraabdominal pressures ( P < 0.001 ) .


A significant decrease in MPV values was also detected with desufflation ( P < 0.001 ) .


Increasing MPV values may reflect increased intraabdominal pressures , which may have a clinical implementation in intraabdominal hypertension .


This study examined the effectiveness of an Internet parenting education and support intervention among mothers with a serious mental illness ( SMI ) .


Sixty mothers diagnosed with a schizophrenia spectrum or mood disorder who had primary/shared custody for a child 18 or younger were enrolled in a randomized controlled trial ( RCT ) with two conditions .


The experimental condition involved participation in the online parental education course and a listserv co-moderated by a parent with a mental illness and a mental health professional .


The control condition involved participation in online education healthy lifestyle course .


Standardized measures were used at baseline and 3 months to assess outcomes .


Using an intent-to-treat approach , group differences over time were assessed using a two-tailed independent sample t test on all dependent variables , including parental efficacy , skills , coping , support , and stress .


Participation in an online parenting intervention for mothers with a SMI enhanced parenting and coping skills , and decreased parental stress .


No support was found for improved efficacy or support .


This RCT establishes that mothers with a SMI are interested in and capable of receiving online parenting education and support .


Findings demonstrate that an online parenting intervention can improve parenting and coping skills and decrease parental stress .


The literature comparing open and arthroscopic repair for glenohumeral instability is conflicting .


We performed a prospective , expertise-based , randomized clinical trial to compare open shoulder stabilization with arthroscopic shoulder stabilization by measuring quality-of-life outcomes and recurrence rates at two years among patients treated for traumatic anterior shoulder instability .


Computer-generated , variable-block-size , concealed randomization allocated 196 patients to either the open-repair group ( n = 98 ) or the arthroscopic-repair group ( n = 98 ) .


An expertise-based randomization design was employed to avoid a differential bias in terms of physician experience .


Outcomes were measured at baseline , at three and six months postoperatively , and at one and two years postoperatively with use of the Western Ontario Shoulder Instability Index ( WOSI ) and the American Shoulder and Elbow Surgeons ( ASES ) functional outcome scale .


Recurrent instability was also analyzed .


There were no significant differences in outcome scores at baseline .


At two years , seventy-nine patients in the open group and eighty-three patients in the arthroscopic group were available for follow-up .


There was no significant difference in mean WOSI scores between the groups ; the mean WOSI score ( and standard deviation ) for the open group was 85.2 20.4 ( 95 % confidence interval [ CI ] = 80.5 to 89.8 ) , and for the arthroscopic group , 81.9 19.8 ( 95 % CI = 77.4 to 86.4 ) ; p = 0.31 .


There was also no significant difference in mean ASES scores : 91.4 12.7 ( 95 % CI = 88.5 to 94.4 ) for the open group and 88.2 15.9 ( 95 % CI = 84.6 to 91.8 ) for the arthroscopic group ; p = 0.17 .


Recurrence rates at two years were significantly different : 11 % in the open group and 23 % in the arthroscopic group ( p = 0.05 ) .


Recurrent instability was more likely in patients with a preoperative Hill-Sachs lesion and in male patients who were twenty-five years old and younger .


There was no significant difference in shoulder motion between the groups at two years .


There was no difference between open and arthroscopic repair in terms of patient quality of life .


Open repair resulted in a significantly lower risk of recurrence .


Secondary outcome data from this trial suggest that open surgical repair may be recommended to reduce the risk of recurrent instability in younger male patients with a Hill-Sachs lesion .


To compare the efficacy , safety , and patient 's perception of two prostaglandin E2 application methods for induction of labour .


Above 36th weeks of gestation , all women , who were admitted to hospital for induction of labour , were prospectively randomised to intravaginal 1 mg or intracervical 0.5 mg irrespective of cervical Bishop score .


The main outcome variables were induction-to-delivery interval , number of foetal blood samples , PDA rate , rate of oxytocin augmentation , rate of vaginal delivery , and patient 's perception using semantic differential questionnaire .


Thirty-nine patients were enrolled in this study .


There was no statistical significant difference between the two groups in regard to perceptions of induction .


The median induction delivery time using intravaginal versus intracervical administration was 29.9 versus 12.8 hours , respectively ( P = 0.04 ) .


No statistically difference between the groups was detected in regard to parity , gestation age , cervical Bishop score , number of foetal blood samples , PDA rate , rate of oxytocin augmentation , and mode of birth .


Irrespective of the cervical Bishop Score , intracervical gel had a shorter induction delivery time without impingement on the women 's perception of induction .


Patients with distributive shock who require high dose vasopressors have a high mortality .


Angiotensin II ( ATII ) may prove useful in patients who remain hypotensive despite catecholamine and vasopressin therapy .


The appropriate dose of parenteral angiotensin II for shock is unknown .


In total , 20 patients with distributive shock and a cardiovascular Sequential Organ Failure Assessment score of 4 were randomized to either ATII infusion ( N = 10 ) or placebo ( N = 10 ) plus standard of care .


ATII was started at a dose of 20 ng/kg/min , and titrated for a goal of maintaining a mean arterial pressure ( MAP ) of 65 mmHg .


The infusion ( either ATII or placebo ) was continued for 6 hours then titrated off .


The primary endpoint was the effect of ATII on the standing dose of norepinephrine required to maintain a MAP of 65 mmHg .


ATII resulted in marked reduction in norepinephrine dosing in all patients .


The mean hour 1 norepinephrine dose for the placebo cohort was 27.629.3 mcg/min versus 7.412.4 mcg/min for the ATII cohort ( P = 0.06 ) .


The most common adverse event attributable to ATII was hypertension , which occurred in 20 % of patients receiving ATII .


30-day mortality for the ATII cohort and the placebo cohort was similar ( 50 % versus 60 % , P = 1.00 ) .


Angiotensin II is an effective rescue vasopressor agent in patients with distributive shock requiring multiple vasopressors .


The initial dose range of ATII that appears to be appropriate for patients with distributive shock is 2 to 10 ng/kg/min .


Clinicaltrials.gov NCT01393782 .


Registered 12 July 2011 .


Asymptomatic and symptomatic malaria during pregnancy has consequences for both mother and her offspring .


Unfortunately , there is insufficient information on the safety and efficacy of most antimalarials in pregnancy .


Indeed , clinical trials assessing antimalarial treatments systematically exclude pregnancy for fear of teratogenicity and embryotoxicity .


The little available information originates from South East Asia while in sub-Saharan Africa such information is still limited and needs to be provided .


A Phase 3 , non-inferiority , multicentre , randomized , open-label clinical trial on safety and efficacy of 4 ACT when administered during pregnancy was carried out in 4 African countries : Burkina Faso , Ghana , Malawi and Zambia .


This is a four arm trial using a balanced incomplete block design .


Pregnant women diagnosed with malaria are randomised to receive either amodiaquine-artesunate ( AQ-AS ) , dihydroartemisinin-piperaquine ( DHA-PQ ) , artemether-lumefantrine ( AL ) , or mefloquine-artesunate ( MQAS ) .


They are actively followed up until day 63 post-treatment and then monthly until 4-6 weeks post-delivery .


The offspring is visited at the time of the first birthday .


The primary endpoint is treatment failure ( PCR adjusted ) at day 63 and safety profiles .


Secondary endpoints included PCR unadjusted treatment failure up to day 63 , gametocyte carriage , Hb changes , placenta malaria , mean birth weight and low birth weight .


The primary statistical analysis will use the combined data from all 4 centres , with adjustment for any centre effects , using an additive model for the response rates .


This will allow the assessment of all 6 possible pair-wise treatment comparisons using all available data .


The strength of this trial is the involvement of several African countries , increasing the generalisability of the results .


In addition , it assesses most ACTs currently available , determining their relative ' - value - ' compared to others .


The balanced incomplete block design was chosen because using all 4-arms in each site would have increased complexity in terms of implementation .


Excluding HIV-positive pregnant women on antiretroviral drugs may be seen as a limitation because of the possible interactions between antiretroviral and antimalarial treatments .


Nevertheless , the results of this trial will provide the evidence base for the formulation of malaria treatment policy for pregnant women in sub-Saharan Africa .


The current evidence supports the clinical benefits of late umbilical cord clamping .


These benefits include increased blood volume and total body iron .


Furthermore , delayed cord clamping facilitates the transplantation of stem cells , which helps the development of infant bodily systems .


However , due to concerns related to postpartum hemorrhaging and neonate jaundice , most maternity units still clamp the cord immediately after a child is born .


This study investigates the impact of delaying cord clamping on neonatal jaundice and postpartum hemorrhage .


A randomized , controlled trial was conducted at a regional teaching hospital in northern Taiwan .


One hundred and five healthy nulliparous women at 36 weeks of pregnancy were included and allocated randomly to the experiment group ( n = 44 ) and the control group ( n = 61 ) .


Participants in the experiment group received delayed cord clamping ( DCC ) at 3 minutes after delivery .


Participants in the control group received early cord clamping ( ECC ) at around 1 minute after delivery .


Clinical measures of the outcomes were measured by the infant transcutaneous bilirubin levels ( TcB ) and postpartum hemorrhage at birth .


A structured questionnaire and biophysical measures were used to collect data on participant demographics , obstetrical information , maternal blood loss at birth , neonate weight and TcB level at hospitalization , and whether or not the infant received phototherapy at 4-7 days postpartum .


Overall , there was no significant difference between the two groups in terms of neonatal jaundice , maternal hemorrhage at birth , and phototherapy rates at time of hospitalization and at 4-7 days postpartum .


The findings of the present study support that late umbilical cord clamping does not increase the risk of maternal postpartum hemorrhaging or neonate jaundice .


Thus , we suggest that clinicians inform clients during prenatal classes of the benefits of delayed cord clamping and also use current , evidence-based knowledge to dispel client worries regarding the dangers to maternal-neonate health of delayed cord clamping .


Before the introduction of the tension-free vaginal tape ( TVT ) procedure for the treatment of female stress urinary incontinence , the colposuspension operation was regarded as the `` gold standard '' procedure .


The laparoscopic variant of the colposuspension was introduced as a less invasive operation .


The aim of the present trial was to compare the new minimally invasive TVT procedure with laparoscopic mesh colposuspension ( LCM ) .


A multicenter randomized clinical trial conducted in six public hospitals in Finland including primary cases of stress incontinence .


Objective treatment success criteria were a negative stress test and no retreatment for stress incontinence .


Patient satisfaction was assessed by Patients Global Impression of Improvement , a visual analog scale , and the Urinary Incontinence Severity Score .


Of 128 randomized patients , 121 underwent the allocated operation .


At the 5-year follow-up 77 % in the TVT group and 84 % in the LCM group could be assessed according to the protocol .


The objective cure rate was significantly higher in the TVT group ( 94 % ) than in the LCM group ( 78 % ) .


Subjective treatment satisfaction ( completely satisfied with the procedure ) was significantly higher in the TVT group ( 64 % ) than in the LCM group ( 51 % ) .


By per protocol analysis both objective and subjective cure rates were significantly higher in the TVT group than in the LCM group .


If cases that were lost to follow-up were regarded as failures , the intension-to-treat analysis found no difference between the groups .


Zinc treatment shortens diarrhea episodes and can prevent future episodes .


In rural Africa , most children with diarrhea are not brought to health facilities .


In a village-randomized trial in rural Kenya , we assessed if zinc treatment might have a community-level preventive effect on diarrhea incidence if available at home versus only at health facilities .


We randomized 16 Kenyan villages ( 1,903 eligible children ) to receive a 10-day course of zinc and two oral rehydration solution ( ORS ) sachets every two months at home and 17 villages ( 2,241 eligible children ) to receive ORS at home , but zinc at the health-facility only .


Children 's caretakers were educated in zinc/ORS use by village workers , both unblinded to intervention arm .


We evaluated whether incidence of diarrhea and acute lower respiratory illness ( ALRI ) reported at biweekly home visits and presenting to clinic were lower in zinc villages , using poisson regression adjusting for baseline disease rates , distance to clinic , and children 's age .