Clinicaltrials.gov no : NCT021683615 .


Knowledge and skills of primary health care workers ( PHCWs ) in primary eye care have been demonstrated to be inadequate in several districts of Kenya , Malawi , and Tanzania .


We tested whether enhanced supervision , focused on improving practical skills over two years , would raise the scores of these workers on a test of basic knowledge and skills .


This was a randomised controlled trial .


All primary health care ( PHC ) facilities within two districts of each country were enrolled and randomly assigned by district ( Kenya , Malawi ) or by health care facility ( Tanzania ) to receive quarterly skills-based supervision by a district eye coordinator or to continue existing routine supervision .


At baseline , a test of basic knowledge and skills in five key areas was administered to PHCWs , and visual acuity ( VA ) charts and working torches were provided .


After two years the test was administered again .


Changes in test scores were compared between the intervention ( enhanced supervision ) and the non-intervention ( routine supervision ) facilities .


All 137 facilities in the six districts were enrolled including 343 PHCWs .


At baseline , no facility had a visual acuity chart and 18 ( 13 % ) had a working torch ; the average total skills scores were 6.04 and 6.38 ( maximum of 12 ) in the non-intervention and the intervention facilities , respectively .


After two years , 16 intervention facilities ( 23.2 % ) had a visual acuity chart correctly placed and 19 ( 27.5 % ) had a working torch , compared to 4 ( 5.9 % ) and 6 ( 8.8 % ) , respectively , in the routine supervision facilities .


At the facility level , the change in overall test scores was +1.84 points in the intervention sites compared to +0.42 points in the non-intervention sites ( p < 0.001 ) .


Staff turnover included about 75 % of the staff by the end of the study .


The improvements in the enhanced supervision facilities were very modest and of questionable clinical significance .


The low impact of the intervention may be due to the high turnover of PHCWs or high absenteeism .


A better understanding of the quality of eye care at PHC facilities and influencing factors are urgently needed before continuing to invest resources in the scale up of this model of task shifting in Africa .


Fall prevention is important for maintaining mobility and independence into old age .


Approaches for reducing falls include exercise , tai chi , and home modifications ; however , causes of falling are multifactorial and include not just physical but cognitive factors .


Cognitive decline occurs with age , but older adults with the greatest declines in executive function experience more falls .


The purpose of this study was twofold : to demonstrate the feasibility of a community-based cognitive training program for cognitively intact Black older adults and to analyze its impact on gait and balance in this population .


This pilot study used a pretest/posttest randomized trial design with assignment to an intervention or control group .


Participants assigned to the intervention completed a computer-based cognitive training class that met 2 days a week for 60 min over 10 weeks .


Classes were held at senior/community centers .


Primary outcomes included balance as measured by the Berg Balance Scale ( BBS ) , 10-meter gait speed , and 10-meter gait speed under visuospatial dual-task condition .


All measures were assessed at baseline and immediately post-intervention .


Participants were community-dwelling Black adults with a mean age of 72.5 and history of falls ( N = 45 ) .


Compared to controls , intervention participants experienced statistically significant improvements in BBS and gait speed .


Mean performance on distracted gait speed also improved more for intervention participants compared to controls .


Findings from this pilot randomized trial demonstrate the feasibility of a community-based cognitive training intervention .


They provide initial evidence that cognitive training may be an efficacious approach toward improving balance and gait in older adults known to have a history of falls .


The effectiveness of greater occipital nerve block ( GONB ) in patients with primary headache syndromes is controversial .


Few studies have been evaluated the usefulness of GONB in patients with migraine without aura ( MWOA ) .


To compare the effectiveness of ultrasound-guided GONB using bupivacaine 0.5 % and placebo on clinical improvement in patients with refractory MWOA in a randomized , double-blinded clinical trial .


A prospective , randomized , placebo-controlled , double-blind pilot trial .


Physical medicine and rehabilitation and neurology departments of a University Hospital .


Thirty-two patients with a diagnosis of MWOA according to the International Classification of Headache Disorders-II criteria were included in the study .


Twenty-three patients ( 2 men , 21 women ) completed the study .


They were randomly assigned to receive either GONB with local anesthetic ( bupivacaine 0.5 % 1.5 mL ) or greater occipital nerve ( GON ) injection with normal saline ( 0.9 % 1.5 mL ) .


Ultrasound-guided GONB was performed to more accurately locate the nerve .


All procedures were performed using a 7 - 13 MHz high-resolution linear ultrasound transducer .


The treatment group was comprised of 11 patients and the placebo group was comprised of 12 patients .


The primary outcome measure was the change in the headache severity score during the one-month post-intervention period .


Headache severity was assessed with a visual analogue scale ( VAS ) from 0 ( no pain ) to 10 ( intense pain ) .


In both groups , a decrease in headache intensity on the injection side was observed during the first post-injection week and continued until the second week .


After the second week , the improvement continued in the treatment group , and the VAS score reached 0.97 at the end of the fourth week .


In the placebo group after the second week , the VAS values increased again and nearly reached the pre-injection levels .


The decrease in the monthly average pain intensity score on the injected side was statistically significant in the treatment group ( P = 0.003 ) , but not in the placebo group ( P = 0.110 ) .


No statistically significant difference in the monthly average pain intensity score was observed on the uninjected side in either group ( treatment group , P = 0.994 ; placebo group , P = 0.987 ) .


No serious side effect was observed after the treatment in either group .


Only one patient had a self-limited vaso-vagal syncope during the procedure .


This trial included a relatively small sample .


This may have been the result of the inclusion of only those patients who correctly completed their pain diaries .


Another major limitation is the short follow-up duration .


Patients were followed for one month after the injection , thus relatively long-term effects of the injection have not been observed .


Ultrasound guided GONB with 1.5 mL of 0.5 % bupivacaine for the treatment of migraine patients is a safe , simple , and effective technique without severe adverse effects .


To increase the effectiveness of the injection , and to implement the isolated GONB , ultrasonography guidance could be suggested .


X-linked retinitis pigmentosa is a severe inherited retinal degenerative disease with a frequency of 1 in 100,000 persons .


Because no cure is available for this orphan disease and treatment options are limited , slowing of disease progression would be a meaningful outcome .


To determine whether high-dose docosahexaenoic acid ( DHA ) , an -3 polyunsaturated fatty acid , slows progression of X-linked retinitis pigmentosa measured by cone electroretinography ( ERG ) .


A 4-year , single-site , randomized , placebo-controlled , double-masked phase 2 clinical trial at a research center specializing in medical retina .


Seventy-eight male patients diagnosed as having X-linked retinitis pigmentosa were randomized to DHA or placebo .


Data were omitted for 2 patients with non-X-linked retinitis pigmentosa and 16 patients who were unable to follow protocol during the first year .


The remaining participants were tested annually and composed a modified intent-to-treat cohort ( DHA group , n = 33 ; placebo group , n = 27 ) .


All participants received a multivitamin and were randomly assigned to oral DHA ( 30 mg/kg/d ) or placebo .


The primary outcome was the rate of loss of cone ERG function .


Secondary outcomes were rod and maximal ERG amplitudes and cone ERG implicit times .


Capsule counts and red blood cell DHA levels were assessed to monitor adherence .


Average ( 6-month to 4-year ) red blood cell DHA levels were 4-fold higher in the DHA group than in the placebo group ( P < .001 ) .


There was no difference between the DHA and placebo groups in the rate of cone ERG functional loss ( 0.028 vs 0.022 log V/y , respectively ; P = .30 ) .


No group differences were evident for change in rod ERG ( P = .27 ) , maximal ERG ( P = .65 ) , or cone implicit time ( no change over 4 years ) .


The rate of cone loss ( ie , event rate ) was markedly reduced compared with rates in previous studies .


No severe treatment-emergent adverse events were found .


Long-term DHA supplementation was not effective in slowing the loss of cone or rod ERG function associated with X-linked retinitis pigmentosa .


Participant dropout and lower-than-expected disease event rate limited power to detect statistical significance .


A larger sample size , longer trial , and attainment of a target blood DHA level ( 13 % ) would be desirable .


While DHA supplementation at 30 mg/kg/d does not present serious adverse effects , routine monitoring of gastrointestinal tolerance is prudent .


clinicaltrials.gov Identifier : NCT00100230 .


To investigate the effect of Chaiqin Chengqi Decoction ( , CQCQD ) on regulating serum matrix metalloproteinase 9 ( MMP-9 ) in patients with severe acute pancreatitis ( SAP ) .


Thirty-five SAP patients hospitalized in West China Hospital from September 1 , 2008 to February 28 , 2009 were randomly assigned to two groups using a computer-derived random number sequence in a ratio of 1:1 , treatment group ( 18 patients ) and the placebo control group ( 17 patients ) .


The patients in the treatment group were administered with CQCQD by gastric perfusion ( 50 mL/2 h ) and retention enema ( 200 mL/6 h ) for 7 days .


The two groups had similar baseline information .


The clinical indicators , including the initial Balthazar 's computed tomography ( CT ) score , acute physiology and chronic health evaluation II ( APACHE II ) scores on 1st , 3rd , 5th and 7th day , incidences and durations of complications and the serum C-reactive protein ( CRP ) , levels of MMP-9 on the 1st , 3rd , 5th and 7th day , were recorded and compared between the two groups .


The serum MMP-9 , CRP and the APACHE II scores on the 3rd , 5th and 7th day in the treatment group were lower than those in the control group ( P < 0.05 ) .


The serum MMP-9 was positively correlated with the APACHE II score on the 1st day ( r = 0.430 , P = 0.01 ) .


The durations of acute respiratory distress syndrome ( 5.42.4 vs. 2.91.3 ) , acute hepatitis ( 4.60.8 vs. 1.90.6 ) and acute heart failure ( 3.91.6 vs. 1.30.6 , < 0.05 ) in the control group were longer than those in the treatment group .


CQCQD could decrease the serum MMP-9 to relieve the severity of clinical symptoms and prevent the development of multiple organ dysfunction syndrome in patients with SAP .


WSG-ARA plus trial evaluated the effect of adjuvant darbepoetin alfa ( DA ) on outcome in node positive primary breast cancer ( BC ) .


One thousand two hundred thirty-four patients were randomized to chemotherapy either with DA ( DA + ; n = 615 ) or without DA ( DA - ; n = 619 ) .


DA ( 500 g q3w ) was started at hemoglobin ( Hb ) levels < 13.0 g/dl ( < 12 g/dl after DA label amendment ) and stopped at Hb levels 14.0 g/dl ( 12 g/dl after label amendment ) .


Primary efficacy end point was event-free survival ( EFS ) ; secondary end points were toxicity , quality of life ( QoL ) and overall survival ( OS ) .


Venous thrombosis ( DA + : 3.0 % , DA - : 1.0 % ; P = 0.013 ) was significantly higher for DA + , but not pulmonary embolism ( 0.3 % in both arms ) .


Median Hb levels were stable in DA + ( 12.6 g/dl ) and decreased in DA - ( 11.7 g/dl ) .


Hb levels > 15 g/dl were reported in 0.8 % of cycles .


QoL parameters did not significantly differ between arms .


At 39 months , DA had no significant impact on EFS ( DA + : 89.3 % , DA - : 87.5 % ; Plog-rank = 0.55 ) or OS ( DA + : 95.5 % , DA - : 95.4 % ; Plog-rank = 0.77 ) .


DA treatment did not impact EFS or OS in routine adjuvant BC treatment .


To observe clinical therapeutic effects of acupuncture for pattern of liver-stagnation and spleen-deficiency in diarrhea-predominant irritable bowel syndrome ( D-IBS ) and its impact on cell factors .


Forty cases were selected and divided into an acupuncture group ( 21 cases ) in which acupuncture was applied and a medicine group ( 19 cases ) in which oral administration of dicetel and bifidobacterium lactobacillus triple viable capsules were applied .


The symptom scores , level of Th1-type cytokine ( IFN-gamma , IL-2 ) and Th2-type cytokine ( IL-4 , IL-10 ) and ratio of IFN-gamma to IL-4 were compared in two groups before and after treatment to analyze acupuncture effect .


The clinical symptoms were improved after one-week treatment in the acupuncture group ( P < 0.05 ) , which had faster onset than the medicine group ( P < 0.05 ) .


The total effective rate was 90.48 % ( 19/21 ) in the acupuncture group , which was superior to 78.95 % ( 15/19 ) in the medicine group ( P < 0.05 ) .


Compared with medicine treatment , imbalanced condition of Th1/Th2 was turning towards the direction of Th2 after acupuncture , indicating a tendency to recover the balance .


The clinical efficacy of acupuncture for D-IBS has close relationship with effectively improving balance of Th1/Th2 in patients with liver-stagnation and spleen-deficiency .


The advanced life support guidelines recommend 2min of cardiopulmonary resuscitation ( CPR ) and minimal hands-off time to ensure sufficient cardiac and cerebral perfusion .


We have observed doctors who shorten the CPR intervals during resuscitation attempts .


During simulation-based resuscitation training , the recommended 2-min CPR cycles are often deliberately decreased in order to increase the number of scenarios .


The aim of this study was to test if keeping 2-min CPR cycles during resuscitation training ensures better adherence to time during resuscitation in a simulated setting .


This study was designed as a randomised control trial .


Fifty-four 4th-year medical students with no prior advanced resuscitation training participated in an extra-curricular one-day advanced life support course .


Participants were either randomised to simulation-based training using real-time ( 120s ) or shortened CPR cycles ( 30-45s instead of 120s ) in the scenarios .


Adherence to time was measured using the European Resuscitation Council 's Cardiac Arrest Simulation Test ( CASTest ) in retention tests conducted one and 12 weeks after the course .


The real-time group adhered significantly better to the recommended 2-min CPR cycles ( time-120s ) ( mean 13 ; standard derivation ( SD ) 8 ) than the shortened CPR cycle group ( mean 45 ; SD 19 ) when tested ( p < 0.001 . )


This study indicates that time is an important part of fidelity .


Variables critical for performance , like adherence to time in resuscitation , should therefore be kept realistic during training to optimise outcome .


Weight loss is associated with reduction in bone mineral density ( BMD ) .


The objective was to address the role of changes in fat mass ( FM ) and lean mass ( LM ) in BMD decline in both sexes .


A 2-year randomized controlled trial , the Preventing Overweight Using Novel Dietary Strategies ( POUNDS-LOST ) .


The setting was the general community .


Enrolled were 424 overweight and obese participants ( mean age , 52 9 y ; 57 % females ) .


Intervention included weight loss diets differing in fat , protein , and carbohydrates .


Main outcome measures were change in spine , total hip ( TH ) , and femoral neck ( FN ) BMD and sex differences after dietary intervention .


At baseline , a stronger correlation between BMD and body composition measurements was observed in women , primarily with LM ( r = 0.419 , 0.507 , and 0.523 for spine , FN , and TH , respectively ; all P < .001 ) .


In men , only LM correlated with hip BMD ( r = 0.298 ; P < .001 ) .


Mean weight loss at 2 years was -6.9 % , without differences among diets .


Two-year changes in BMD were 0.005 ( P = .04 ) , -0.014 ( P < .001 ) , and -0.014 g/cm ( 2 ) ( P < .001 ) , at the spine , TH , and FN , respectively .


These changes directly correlated with changes in LM in women ( r = 0.200 , 0.324 , and 0.260 for spine , FN , and TH , respectively ) , whereas FM loss correlated only with changes in TH BMD ( 0.274 ; P < .001 ) .


In men , changes in LM ( -0.323 ; P < .001 ) and FM ( -0.213 ; P = .027 ) negatively correlated with changes in spine BMD .


Weight loss diets result in sex-specific effects on BMD .


Although men exhibited a paradoxical increase in spine BMD , women tended to decrease in BMD at all sites .


Determine whether a church-based social marketing program increases older adults ' participation in balance classes for fall prevention .


In 2009-10 , 51 churches ( 7101 total members aged 60 ) in Colorado , U.S.A. were randomized to receive no intervention or a social marketing program .


The program highlighted benefits of class participation ( staying independent , building relationships ) , reduced potential barriers ( providing convenient , subsidized classes ) , and communicated marketing messages through church leaders , trained `` messengers , '' printed materials and church-based communication channels .


Between-group differences in balance class enrollment and marketing message recall among congregants were compared using Wilcoxon Two-Sample Test and regression models .


Compared to 25 control churches , 26 churches receiving the social marketing program had a higher median proportion ( 9.8 % vs. 0.3 % ; p < 0.001 ) and mean number ( 7.0 vs. 0.5 ; IRR = 11.2 [ 95 % CI : 7.5 , 16.8 ] ) of older adult congregants who joined balance classes .


Intervention church members were also more likely to recall information about preventing falls with balance classes ( AOR = 6.2 ; 95 % CI : 2.6 , 14.8 ) and availability of classes locally ( AOR = 7.7 ; 95 % CI : 2.6 , 22.9 ) .


Church-based social marketing effectively disseminated messages about preventing falls through balance classes and , by emphasizing benefits and reducing barriers and costs of participation , successfully motivated older adults to enroll in the classes .


Low serum 25-hydroxyvitamin D [ 25 ( OH ) D ] concentrations have been associated with insulin resistance , the metabolic syndrome , and type 2 diabetes .


Because many non-Western immigrants in the Netherlands are vitamin D deficient , obese , and at high risk of diabetes , vitamin D supplementation may contribute to prevent diabetes and insulin resistance .


We examined the effect of vitamin D supplementation on insulin sensitivity and cell function in overweight , vitamin D-deficient , non-Western immigrants at high risk of diabetes .


The study was a 16-wk , randomized , placebo-controlled trial .


A total of 130 non-Western immigrants with prediabetes ( fasting glucose concentration > 5.5 mmol/L or random glucose concentration from 7.8 to 11.1 mmol/L ) and vitamin D deficiency ( serum 25 [ OH ] D concentration < 50 nmol/L ) were randomly assigned after stratification by sex to receive either cholecalciferol ( 1200 IU/d ) or a placebo for 16 wk .


All participants received 500 mg Ca/d as calcium carbonate .


The primary outcome was the difference in the area under the curve of insulin and glucose after a 75-g oral-glucose-tolerance test after 4 mo of treatment .


Secondary outcomes were insulin-sensitivity variables , cell-function variables , and metabolic syndrome .


Mean serum 25 ( OH ) D concentrations increased significantly in the vitamin D compared with placebo groups .


After 4 mo of therapy , the mean between-group difference was 38 nmol/L ( 95 % CI : 32.1 , 43.9 nmol/L ; P < 0.001 ) .


There was no significant effect on insulin sensitivity and cell function .


In a post hoc analysis , when patients with diabetes at baseline were excluded , a significant increase in the insulinogenic index was observed in participants who obtained a 25 ( OH ) D concentration 60 nmol/L ( P = 0.040 ) .


Vitamin D supplementation in non-Western vitamin D-deficient immigrants with prediabetes did not improve insulin sensitivity or cell function or change the incidence of metabolic syndrome .


However , after the exclusion of diabetic subjects , an improvement in the insulinogenic index was observed in participants who obtained a 25 ( OH ) D concentration 60 nmol/L .


This trial was registered at trialregister.nl as NTR1827 .


Unilateral spatial neglect ( USN ) is a visual-perceptual disorder that entails the inability to perceive and integrate stimuli on one side of the body , resulting in the neglect of one side of the body .


Stroke patients with USN present with extensive functional disability and duration of therapy input .


To determine the effect of saccadic eye movement training with visual scanning exercises ( VSEs ) integrated with task-specific activities on USN poststroke .


A matched-pair randomized control trial was conducted .


Subjects were matched according to their functional activity level and allocated to either a control ( n = 12 ) or an experimental group ( n = 12 ) .


All patients received task-specific activities for a 4-week intervention period .


The experimental group received saccadic eye movement training with VSE integrated with task specific activities as an `` add on '' intervention .


Assessments were conducted weekly over the intervention period .


Statistical significant difference was noted on the King-Devick Test ( P = .021 ) , Star Cancellation Test ( P = .016 ) , and Barthel Index ( P = .004 ) .


Intensive saccadic eye movement training with VSE integrated with task-specific activities has a significant effect on USN in patients poststroke .


Results of this study are supported by findings from previously reviewed literature in the sense that the effect of saccadic eye movement training with VSE as an intervention approach has a significant effect on the visual perceptual processing of participants with USN poststroke .


The significant improved visual perceptual processing translate to significantly better visual function and ability to perform activities of daily living following the stroke .


In this study we used nationwide population based data to compare perioperative outcomes , including severe bladder injury , between monopolar andbipolar transurethral resection of bladder tumors .


Data of patients with clinical T2 or less bladder cancer who underwent monopolar or bipolar transurethral bladder tumor resection were collected from 788 hospitals in the Japanese Diagnosis Procedure Combination database 2007-2012 .


One-to-one propensity score matching was performed .


End points assessed were severe bladder injury requiring placement ofadrainage tube or repair surgery within 3 postoperative days , hemostasis procedures consisting of clot removal or transurethral coagulation within 3postoperative days , transfusion , other complications , anesthesia duration , postoperative length of stay and total costs .


Multivariate analyses compared outcomes of bipolar and monopolar transurethral bladder tumor resection with gender , age , Charlson comorbidity index , clinical stage , hospital volume and hospital academic status as covariates .


A total of 8,188 pairs were generated .


Compared with monopolar transurethral bladder tumor resection , bipolar resection was associated with a significantly lower incidence of severe bladder injury ( 0.3 % vs 0.6 % , OR 0.57 ) , other complications ( 4.6 % vs 5.8 % , OR 0.78 ) , slightly shorter postoperative stay ( mean 6.4 vs 6.7 days , difference -3.3 % ) and slightly lower total costs ( mean $ 4,628 vs $ 4,727 ; difference -1.1 % , all p < 0.05 ) .


There were no differences in postoperative hemostasis procedures , transfusion and anesthesia duration .


Bipolar transurethral bladder tumor resection was associated with a substantially lower incidence of several perioperative complications including severe bladder injury .


The findings support the benefit of bipolar transurethral bladder tumor resection over monopolar resection in real-world clinical practice .


To examine effects of a rowing exercise regimen versus a chest physical therapy program on pulmonary function in children with Down syndrome .


Twenty-nine participants of both sexes , between 8 to 12 years of age , participated in this study .


They were assigned randomly into 2 study groups .


The first group ( A ) received a chest physical therapy program , while the second group ( B ) received an aerobic exercise regimen using a rowing ergometer .


Vital capacity , forced vital capacity , forced expiratory volume after 1 second , and peak expiratory flow rate were measured before and after 12 successive weeks of treatment .


Significant improvements in all measured variables were found posttreatment in both study groups .


No significant difference between the 2 groups was found posttreatment .


Rowing exercise could be effective in improving pulmonary functions in children with Down syndrome .


A systematic assessment of potential disease-modifying compounds for Parkinson 's disease concluded that pioglitazone could hold promise for the treatment of patients with this disease .


We assessed the effect of pioglitazone on the progression of Parkinson 's disease in a multicentre , double-blind , placebo-controlled , futility clinical trial .


Participants with the diagnosis of early Parkinson 's disease on a stable regimen of 1 mg/day rasagiline or 10 mg/day selegiline were randomly assigned ( 1:1:1 ) to 15 mg/day pioglitazone , 45 mg/day pioglitazone , or placebo .


Investigators were masked to the treatment assignment .


Only the statistical centre and the central pharmacy knew the treatment name associated with the randomisation number .


The primary outcome was the change in the total Unified Parkinson 's Disease Rating Scale ( UPDRS ) score between the baseline and 44 weeks , analysed by intention to treat .


The primary null hypothesis for each dose group was that the mean change in UPDRS was 3 points less than the mean change in the placebo group .


The alternative hypothesis ( of futility ) was that pioglitazone is not meaningfully different from placebo .


We rejected the null if there was significant evidence of futility at the one-sided alpha level of 010 .


The study is registered at ClinicalTrials.gov , number NCT01280123 .


210 patients from 35 sites in the USA were enrolled between May 10 , 2011 , and July 31 , 2013 .


The primary analysis included 72 patients in the 15 mg group , 67 in the 45 mg group , and 71 in the placebo group .


The mean total UPDRS change at 44 weeks was 442 ( 95 % CI 255-628 ) for 15 mg pioglitazone , 513 ( 95 % CI 317-708 ) for 45 mg pioglitazone , and 625 ( 95 % CI 435-815 ) for placebo ( higher change scores are worse ) .


The mean difference between the 15 mg and placebo groups was -183 ( 80 % CI -356 to -010 ) and the null hypothesis could not be rejected ( p = 019 ) .


The mean difference between the 45 mg and placebo groups was -112 ( 80 % CI -293 to 069 ) and the null hypothesis was rejected in favour of futility ( p = 009 ) .


Planned sensitivity analyses of the primary outcome , using last value carried forward ( LVCF ) to handle missing data and using the completers ' only sample , suggested that the 15 mg dose is also futile ( p = 009 for LVCF , p = 009 for completers ) but failed to reject the null hypothesis for the 45 mg dose ( p = 012 for LVCF , p = 019 for completers ) .


Six serious adverse events occurred in the 15 mg group , nine in the 45 mg group , and three in the placebo group ; none were thought to be definitely or probably related to the study interventions .


These findings suggest that pioglitazone at the doses studied here is unlikely to modify progression in early Parkinson 's disease .


Further study of pioglitazone in a larger trial in patients with Parkinson 's disease is not recommended .


National Institute of Neurological Disorders and Stroke .


Compared with adults without type 2 diabetes mellitus , those with the disease experience more limitations in their physical functioning ( PF ) .


Look AHEAD is a large multicenter trial that examined the effects of an intensive lifestyle intervention ( ILI ) for weight loss on cardiovascular outcomes compared with diabetes support and education ( DSE ) .


Although the current study compared treatment differences between ILI and DSE on PF , the primary goal was to examine whether this effect was moderated by age and history of cardiovascular disease at enrollment .


Overweight or obese adults with type 2 diabetes mellitus ( n = 5,145 ) were randomly assigned to either ILI or DSE .


The mean ( SD ) age and % females in ILI was 58.9 years ( 6.9 ) and 59.8 % ; it was 58.6 years ( 6.8 ) and 59.5 % in DSE .


Analysis in 4,998 participants assessed the differential rates of decline in PF across a period of 8 years for the ILI and DSE groups .


ILI resulted in improved PF compared with DSE after 1 year ( p < .0001 ) and was maintained across time .


Within the ILI , older adults experienced greater improvements than younger adults ( p < .0001 ) .


By year 2 , persons in ILI with preexisting cardiovascular disease were no different in PF than in DSE participants with preexisting cardiovascular disease .


With the exception of persons who had a history of cardiovascular disease , ILI slowed the decline in PF with type 2 diabetes mellitus despite weight regain , an effect that was stronger for older than younger participants and could translate into reductions in falls and disability .


Flexible laryngeal mask airway is a commonly used supraglotic airway device ( SAD ) during ophthalmic surgeries .


Air-Q intubating laryngeal airway ( ILA ) is a newer SAD used as primary airway device and as a conduit for intubation as well .


Available literature shows that air-Q performs equal or better than other SADs in children and adults .


However , limited data is available using air-Q in infants and small children < 10 kg .


So , our aim was To compare the performance and efficacy of these two devices in infants and small children .


Our hypothesis is that air-Q due to its improved cuff design will yield better airway seal pressures and improved laryngeal alignment as compared to flexible laryngeal mask airway .


ASA III infants and children weighing < 10 kg , undergoing cataract or glaucoma surgery , were randomly divided into two groups of 25 each .


After induction of anesthesia and muscle relaxation , we measured oropharyngeal leak pressure ( OLP ) , fibre-optic ( FO ) view of glottis , first insertion success rate , time to insert , and any other complications .


There was no difference between the groups in demographic data , first insertion success rate , time to insert , and postoperative complications .


Air-Q provided significantly more OLP [ 21.1 6.4 cmH2O vs 17.4 4.1 cmH2O , P = 0.02 ] and better FO view of glottis ( good view 84 % vs 48 % , P = 0.0016 ) as compared to flexible laryngeal mask airway .


We conclude that air-Q is superior to flexible laryngeal mask airway in providing higher airway sealing pressures and better FO grade of laryngeal view in infants and children .


Initial posttraumatic stress disorder ( PTSD ) care is often delayed and many with PTSD go untreated .


Acupuncture appears to be a safe , potentially nonstigmatizing treatment that reduces symptoms of anxiety , depression , and chronic pain , but little is known about its effect on PTSD .


Fifty-five service members meeting research diagnostic criteria for PTSD were randomized to usual PTSD care ( UPC ) plus eight 60-minute sessions of acupuncture conducted twice weekly or to UPC alone .


Outcomes were assessed at baseline and 4 , 8 , and 12 weeks postrandomization .


The primary study outcomes were difference in PTSD symptom improvement on the PTSD Checklist ( PCL ) and the Clinician-administered PTSD Scale ( CAPS ) from baseline to 12-week follow-up between the 2 treatment groups .


Secondary outcomes were depression , pain severity , and mental and physical health functioning .


Mixed model regression and t test analyses were applied to the data .


Mean improvement in PTSD severity was significantly greater among those receiving acupuncture than in those receiving UPC ( PCL = 19.813.3 vs. 9.712.9 , P < 0.001 ; CAPS = 35.020.26 vs. 10.920.8 , P < 0.0001 ) .


Acupuncture was also associated with significantly greater improvements in depression , pain , and physical and mental health functioning .


Pre-post effect-sizes for these outcomes were large and robust .


Acupuncture was effective for reducing PTSD symptoms .


Limitations included small sample size and inability to parse specific treatment mechanisms .


Larger multisite trials with longer follow-up , comparisons to standard PTSD treatments , and assessments of treatment acceptability are needed .


Acupuncture is a novel therapeutic option that may help to improve population reach of PTSD treatment .


To observe the clinical efficacy of acupuncture at Hegu ( LI 4 ) on central facial nerve paralysis after ischemic stroke , and explore dose-effect relationship among different stimulation intensities of acupuncture at Hegu ( LI 4 ) as well as its optimal treatment plan .


According to different acupuncture stimulation intensities which were based on treatment time and needle insertion direction , fifty patients were randomly divided into a Hegu 1 group , a Hegu 2 group , a Hegu 3 group , a Hegu 4 group and a control group , ten cases in each one .


Different stimulation intensities of acupuncture at Hegu ( LI 4 ) combined with facial paralysis acupoints , including Yingxiang ( LI 20 ) , Dicang ( ST 4 ) , Jiache ( ST 6 ) and Quanliao ( SI 18 ) , were applied in Hegu 1 to 4 groups ; meanwhile acupuncture at stroke acupoints , including Neiguan ( PC 6 ) , Shuigou ( GV 26 ) and Sanyinjiao ( SP 6 ) , and medication treatment were adopted .


Except acupuncture at Hegu ( LI 4 ) , the treatment of the control group was identical as Hegu groups .


The treatment duration lasted for 14 days .


The House-Brackmann facial never grading systems ( H-B ) , Toronto facial grading system ( TFGS ) , degrees of facial never paralysis ( DFNP ) , facial disability index ( FDI ) and clinical efficacy were compared among groups .


( 1 ) Compared before the treatment , H-B , TFGS , DFNP and physical function score in FDI were all improved significantly in the Hegu 1 to 4 groups ( all P < 0.05 ) , but social function score in FDI was not obviously improved ( all P > 0.05 ) ; all the scores in the control group were not evidently changed ( all P > 0.05 ) .


( 2 ) Compared with the control group , differences of H-B before and after treatment in the Hegu 1 to 4 groups , differences of TFGS in the Hegu 2 group and differences of DFNP in the Hegu 1 and Hegu 2 group were significantly improved ( all P < 0.05 ) .


The differences of any scale among Hegu 1 to 4 groups were not significant ( all P > 0.05 ) , in which the most evident change was found in Hegu 2 group .


( 3 ) The total effective rate was 90.0 % ( 9/10 ) , 100.0 % ( 10/10 ) , 90.0 % ( 9/10 ) and 80.0 % ( 8/10 ) in Hegu 1 to 4 groups , which were significantly higher than 60.0 % ( 6/10 ) in the control group ( all P < 0.05 ) .


Acupuncture at Hegu ( LI 4 ) has affirmative clinical efficacy on central facial nerve paralysis after ischemic stroke , in which oblique insertion along the opposite direction of meridian for 5 s of twirling manipulation has the best clinical effect .


Internet support group ( ISG ) members benefit from receiving social support and , according to the helper therapy principle , by providing support to others .


To test the mental health benefits of providing support to others , this trial compared the efficacy of a standard ISG ( S-ISG ) and an enhanced prosocial ISG ( P-ISG ) .


A two-armed randomized controlled trial with 1-month pretest and post-test assessments was conducted with women ( N = 184 ) diagnosed in the past 36 months with nonmetastatic breast cancer who reported elevated anxiety or depression .


Women were randomly assigned to either the S-ISG or P-ISG condition .


Both conditions included six professionally facilitated live chat sessions ( 90-minute weekly sessions ) and access to an asynchronous discussion board ; P-ISG also included structured opportunities to help and encourage others .


Relative to the S-ISG , participants in the P-ISG condition exhibited more supportive behaviors ( emotional , informational , and companionate support ) , posted more messages that were other-focused and fewer that were self-focused , and expressed less negative emotion ( P < .05 ) .


Relative to the S-ISG , participants in the P-ISG condition had a higher level of depression and anxiety symptoms after the intervention ( P < .05 ) .


Despite the successful manipulation of supportive behaviors , the P-ISG did not produce better mental health outcomes in distressed survivors of breast cancer relative to an S-ISG .


The prosocial manipulation may have inadvertently constrained women from expressing their needs openly , and thus , they may not have had their needs fully met in the group .


Helping others may not be beneficial as a treatment for distressed survivors of breast cancer .


Polychlorinated biphenyls ( PCBs ) and dioxin given to experimental animals increase the blood pressure .


We therefore investigated if circulating levels of persistent organic pollutants ( POPs ) were related to hypertension in a population-based sample of men and women .


One thousand and sixteen subjects aged 70 years were investigated in the Prospective Investigation of the Vasculature in Uppsala Seniors ( PIVUS ) study .


Twenty-three POPs were analyzed using high-resolution gas chromatography/high-resolution mass spectrometry ( HRGC/HRMS ) .


Hypertension was defined as a systolic blood pressure 140mmHg or a diastolic blood pressure 90mmHg , and/or use of antihypertensive medication .


Seven hundred and thirty-two subjects ( 72 % ) showed hypertension .


When the POPs were treated as continuous variables and adjusted for gender only , two PCBs with a low number of chlorine atoms ( PCB 105 and 118 ) were related to prevalent hypertension .


Also the OC pesticide p , p ' - DDE was related to hypertension .


The strongest of these associations was seen for p , p ' - DDE ( OR 1.35 for a 1 SD change , 95 % CI 1.17-1 .56 , p < 0.0001 ) .


Following further adjustment also for BMI , smoking status , education level and exercise habits , only p , p ' - DDE was still significantly related to hypertension ( OR 1.23 for a 1 SD change , 95 % CI 1.06-1 .43 , p = 0.006 ) .


In this cross-sectional analysis of an elderly population , high levels of circulating levels of p , p ' - DDE were associated with prevalent hypertension , further strengthening the experimental findings that POPs might influence blood pressure .


To compare the effectiveness of buddy strapping and aluminum orthosis for treatment of proximal interphalangeal ( PIP ) joint hyperextension injuries .


We also evaluated the effect of age on the outcome by comparing our results in adults and children .


One hundred twenty-one consecutive patients with a PIP joint hyperextension injury of the index , middle , ring , or little finger and without fracture were evaluated .


Patients were randomly assigned into 2 groups .


In the first group , treatment included buddy strapping of the injured finger to its neighbor noninjured finger for a week .


In the second group , immobilization was secured with an aluminum extension blocking orthosis for a week in 15 flexion .


Assessment of motion , edema , pain , and strength were performed weekly for the first month and then at 3 , 6 , and 12 months after injury .


The patients treated with buddy strapping exhibited similar outcomes compared with those treated with aluminum orthoses .


In patients with full recovery , buddy strapping allowed earlier recovery of motion and resolution of edema and pain compared with aluminum orthosis immobilization .


Furthermore , PIP injuries appear to have better outcomes in children than in adults .


Buddy strapping is easy and effective treatment for PIP joint hyperextension injuries .


Therapeutic I.


Approximately 20 % of newborns infants need respiratory support at birth .


This study evaluated whether video-based education could improve quality of positive pressure ventilation ( PPV ) performed by inexperienced staff during neonatal resuscitation .


Fourth-year medical students were randomly paired and instructed to give PPV to a modified manikin as single-person resuscitators and as two-person-paired resuscitators using either an air cushion rim mask or a round mask before and after watching a self-instructional video .


Airway pressure , gas flow , tidal volume and mask leak were recorded .


PPV performance quality was analysed using video recording .


Mask leak was lower during one-person ventilation when using the air cushion rim mask ( 56 16 % ) compared to the round mask ( 71 19 % ) .


Round mask leak during one-person ventilation was significantly lower when using the two point top hold in contrast to the ` o.k. ' rim hold ( before training : 63 22 % vs. 72 18 % , after training : 57 17 % vs. 77 12 % ) .


Watching a self-instructional video improved performance quality scores of both correct head positioning , and the quality of airway manoeuvres compared to baseline , however mask leak was not significantly reduced .


A self-instructional video significantly improved bag mask PPV performance in inexperienced providers but did not improve mask leak in a model of neonatal resuscitation .


Internet-based interventions for smoking cessation could help millions of people stop smoking at very low unit costs ; however , long-term biochemically verified evidence is scarce and such interventions might be less effective for smokers with low socioeconomic status than for those with high status because of lower online literacy to engage with websites .


We aimed to assess a new interactive internet-based intervention ( StopAdvisor ) for smoking cessation that was designed with particular attention directed to people with low socioeconomic status .


We did this online randomised controlled trial between Dec 6 , 2011 , and Oct 11 , 2013 , in the UK .


Participants aged 18 years and older who smoked every day were randomly assigned ( 1:1 ) to receive treatment with StopAdvisor or an information-only website .


Randomisation was automated with an unseen random number function embedded in the website to establish which treatment was revealed after the online baseline assessment .


Recruitment continued until the required sample size had been achieved from both high and low socioeconomic status subpopulations .


Participants , and researchers who obtained data and did laboratory analyses , were masked to treatment allocation .


The primary outcome was 6 month sustained , biochemically verified abstinence .


The main secondary outcome was 6 month , 7 day biochemically verified point prevalence .


Analysis was by intention to treat .


Homogeneity of intervention effect across the socioeconomic subsamples was first assessed to establish whether overall or separate subsample analyses were appropriate .


The study is registered as an International Standard Randomised Controlled Trial , number ISRCTN99820519 .


We randomly assigned 4613 participants to the StopAdvisor group ( n = 2321 ) or the control group ( n = 2292 ) ; 2142 participants were of low socioeconomic status and 2471 participants were of high status .


The overall rate of smoking cessation was similar between participants in the StopAdvisor and control groups for the primary ( 237 [ 10 % ] vs 220 [ 10 % ] participants ; relative risk [ RR ] 106 , 95 % CI 089-127 ; p = 049 ) and the secondary ( 358 [ 15 % ] vs 332 [ 15 % ] participants ; 106 , 093-122 ; p = 037 ) outcomes ; however , the intervention effect differed across socioeconomic status subsamples ( 144 , 099-209 ; p = 00562 and 137 , 102-184 ; p = 00360 , respectively ) .


StopAdvisor helped participants with low socioeconomic status stop smoking compared with the information-only website ( primary outcome : 90 [ 8 % ] of 1088 vs 64 [ 6 % ] of 1054 participants ; RR 136 , 95 % CI 100-186 ; p = 00499 ; secondary outcome : 136 [ 13 % ] vs 100 [ 10 % ] participants ; 132 , 103-168 , p = 00267 ) , but did not improve cessation rates in those with high socioeconomic status ( 147 [ 12 % ] of 1233 vs 156 [ 13 % ] of 1238 participants ; 095 , 077-117 ; p = 061 and 222 [ 18 % ] vs 232 [ 19 % ] participants ; 096 , 081-113 , p = 064 , respectively ) .


StopAdvisor was more effective than an information-only website in smokers of low , but not high , socioeconomic status .


StopAdvisor could be implemented easily and made freely available , which would probably improve the success rates of smokers with low socioeconomic status who are seeking online support .


National Prevention Research Initiative .


The efficiency of inhibitory pain descending pathways ( evaluated using conditioned pain modulation [ CPM ] ) has not been studied in postherpetic neuralgia ( PHN ) .


To compare CPM in PHN patients with healthy controls .


Nine PHN patients and nine control individuals were matched according to age and sex .


Amplitudes of cortical thermal-evoked potentials were recorded on the surface of the scalp ; clinical pain and thermal pain were evaluated on a 0 to 10 numerical rating scale , at baseline and at intervals during the 6 min after CPM ( elicited by a cold pressor test , 8C ) .


A battery of cognitive tests was performed .


Amplitude differences , percentages and related areas under the curve ( AUC <span style="vertical-align: sub"> CPM <span> ) were calculated and all data were compared between both groups ; P < 0.05 was considered to be statistically significant .


AUC <span style="vertical-align: sub"> CPM0-6 min <span> was significantly lower in PHN patients compared with controls ( -3951 Vmin versus -14466 Vmin ; P = 0.0012 ) and correlated ( P = 0.04 ) with clinical pain intensity .


Pain ratings before CPM were similar in both groups but were significantly lower in the control group 3 min after the cold pressor test .


Cognitive test results were not significantly different .


Psychophysical and electrophysiological approaches have shown that patients with PHN exhibit a deficiency of pain inhibition modulation , which could signal a predisposing factor to developing chronic pain .


This deficiency was not linked to the cognitive performance but rather to subtle in situ cognitivoemotional adaptations , which remain to be investigated .


To present detailed adverse event ( AE ) data from a randomized controlled trial ( RCT ) of a home-based exercise program delivered to an elderly high-risk population by an exercise therapist after medical clearance from a general practitioner ( GP ) .


Randomized controlled trial .


General practitioner practices and participant homes .


Community-dwelling , chronically ill , mobility-limited individuals aged 70 and older ( mean 80 5 ) participating in a RCT of an exercise program ( HOMEfit ; ISRCTN17727272 ) ( N = 209 ; n = 106 experimental , n = 103 control ; 74 % female ) .


A 12-week multidimensional home-based exercise program ( experimental ) versus baseline physical activity counseling ( control ) .


An exercise therapist delivered both interventions to participants during counseling sessions at the GP 's practice and on the telephone .


Adverse events were documented at least at every counseling session and assessed by the GP and an AE manager .


One hundred fifty-one AEs were reported in 47 % ( n = 99 ) of all participants .


Twenty-one ( 14 % ) events were classified as serious .


In six events ( 4 % ; n = 4 experimental , n = 2 control ) , participation in the study had to be discontinued immediately .


In 25 events ( 17 % ; n = 9 experimental , n = 16 control ) , the intervention had to be suspended .


The intervention was determined to have caused two events ( both nonserious and in the experimental group ) .


Even though the program appears to be safe , high morbidity unrelated to exercise can constitute a critical challenge for sustained exercise participation .


Candidates for liver transplantation may have malnutrition , fatigue , loss of muscle mass and function .


The combination of these factors leads to overall physical disability and physical inactivity .


The aim of the study was to evaluate the effects of a respiratory physiotherapeutic program on liver transplantation candidates .


Forty-two patients were evaluated by respiratory muscle strength , surface electromyography of the rectus abdominis and diaphragm , and spirometry .


We also applied the SF-36 .


The patients were divided into two groups : 12 randomly assigned to the control group and 5 in the intervention group .


The intervention consisted of an explanatory and illustrative manual to be followed at home with diaphragmatic breathing exercises , diaphragmatic isometric exercise , Threshold IMT , lifting the upper limbs with a bat , and strengthening the abdominals .


Significant difference was found between initial forced expiratory flow ( FEF ) 25-75 % ( P = .042 ) and final FEF25-75 in the intervention group .


The control group had significant difference ( P = .036 ) in the diaphragm RMS between initial time and end time .


In conclusion , the control group showed greater electrical activity of the diaphragm after 3 months .


The intervention group benefited from the exercise , thus improving the FEF25-75 % .


To evaluate the effects of a tailored information package for rectal cancer patients on satisfaction with information , anxiety and depression and readjustment .


The study used a randomised control trial method .


Seventy six patients undergoing surgery and treatment for rectal cancer were randomly assigned to an intervention ( n = 43 ) or control group ( n = 33 ) .


The intervention group received an information pack tailored according to their treatment plan and preferred information .


The control group received the information currently given to these patients .


Satisfaction with information was measured using the Patient Satisfaction with Cancer Treatment Education ( PSCaTE ) scale , anxiety and depression were measured using the Hospital Anxiety and Depression Scale ( HADS ) and readjustment was measured using the Reintegration to Normal Living Index , at three time points .


There was a statistically significant difference between the intervention and control group on pre and post intervention scores with patients in the intervention group expressing a higher level of satisfaction with information than those in the control group at Times 2 and 3 ( p = 0.00 for both ) .


The intervention group also had a significantly lower anxiety score than the control group at Time 3 ( p = 0.03 ) .


There was no difference between depression and readjustment scores in the two groups .


The results support the hypothesis that a tailored information pack for patients with rectal cancer will positively affect satisfaction with information .


These results will enhance the knowledge base surrounding the provision of tailored information to specific patient groups .


After subcutaneous injection insulin glargine is rapidly metabolized to M1 and M2 .


In vitro , both M1 and M2 have metabolic effects and bind to IGF-1R similarly to human insulin , whereas glargine exhibits a higher affinity for the IGF-1R and greater mitogenetic effects .


The present study was specifically designed to establish the dose-response metabolism of glargine over 24 h following s.c. injection in T2DM subjects on long-term use of glargine .


Ten subjects with T2DM were studied during 24 h after s.c. injection of 0.4 ( therapeutic ) and 0.8 ( high dose ) U/kg of glargine on two separate occasions during euglycaemic clamps ( cross-over design ) .


Glargine , M1 and M2 over 24 h period were determined in appropriately processed plasma samples by a specific liquid chromatography-tandem mass spectrometry assay .


Plasma M1 concentration ( AUC0-24 h ) was detected in all subjects and increased by increasing the glargine dose from therapeutic to high dose ( p = 0.008 ) .


Glargine was detectable in 6 ( therapeutic dose ) and 9 ( high dose ) out of the 10 subjects and also increased by increasing the dose ( p = 0.031 ) .


However , glargine concentration ( AUC0-24 h -- high dose ) represented at most only 9.7 % ( 4.6-15 % ) of the total amount of insulin measured in the blood .


M2 was not detected at all .


In T2DM people on long-term use of insulin glargine , even with higher doses ( 0.8 U/kg ) , glargine is nearly totally metabolized to the active metabolite M1 .


Glargine is often detectable in plasma , but its concentration remains well below that needed in vitro to potentiate IGF-1R binding and mitogenesis .


The main aim of this pilot study was to investigate an advanced version of eye movement desensitization and reprocessing ( EMDR ) for reducing anxiety .


Fifty participants were asked at two times of measurement ( T1 and T2 with a rest of 4 weeks ) to generate anxiety via the recall of autobiographical memories according to their anxiety .


Furthermore , the participants were randomly assigned to an experimental group and a control group , and the experimental group received an intervention of 1-2 h with the advanced version of EMDR in order to their anxiety 2 weeks after T1 .


At T1 as well as T2 , we measured the intensity of participants ' anxiety with a Likert scale ( LS ) and collected participants ' state ( temporary ) and trait ( chronic ) anxiety with the State-Trait Anxiety Inventory ( STAI ) .


In addition , we measured participants ' physical performance in a test for the finger musculature under the induction of their anxiety .


The results showed that participant 's ratings of their perceived intensity of anxiety ( measured by a 9-point LS ) and the state and trait anxiety decreased significantly in the experimental group but not in the control group from T1 to T2 .


Moreover , the physical performance under the induction of participants ' anxiety increased significantly in the experimental group from T1 to T2 and there were no significant changes in the control group .


The study could show that the advanced version of EMDR is an appropriate method to reduce anxiety .


Identification of novel biomarkers of diabetes risk help to understand mechanisms of pathogenesis and improve risk prediction .


Our objectives were to examine the relationships between adipokines , biomarkers of inflammation and endothelial function and development of type 2 diabetes ; and to assess the relevance of including these biomarkers in type 2 diabetes prediction risk models .


1345 subjects from the SU.VI.MAX study , who were free of diabetes at baseline and who completed 13 years of follow-up were included in the present analyses .


Odds ratios ( OR ) with 95 % confidence intervals ( 95 % CI ) of incident type 2 diabetes associated with a 1-SD increase in adiponectin , leptin , C-reactive protein ( CRP ) , soluble intracellular adhesion modecule-1 ( sICAM-1 ) , soluble vascular cell adhesion molecule 1 ( sVCAM-1 ) , E-selectin and monocyte chemoattractant protein-1 ( MCP-1 ) were estimated .


Predicitive performances of models including biomarkers were assessed with area under the receiver operating curves ( AUC ) and integrated discrimination improvement ( IDI ) statistics .


82 subjects developed type 2 diabetes during follow-up .


The risk of developing type 2 diabetes increased with increasing concentrations of leptin ( 2.04 ( 1.28 ; 3.26 ) ) , sICAM-1 ( 1.39 ( 1.08 ; 1.78 ) ) and sVCAM-1 ( 1.29 ( 1.01 ; 1.64 ) ) .


Type 2 diabetes associations with leptin remained significant after adjusting for a combination of biomarkers .


Models adjusted for novel biomarkers had improved performance compared to models adjusted for classical risk factors as assessed by IDI , but not by AUC .


Adipokines , biomarkers of inflammation and endothelial function were significantly associated to onset of type 2 diabetes .


However their inclusion in predictive scores is not supported by the present study .


To our knowledge , no randomised study has compared rates of uncovered stent struts in everolimus ( EES ) vs. new-generation zotarolimus-eluting ( ZES-R ) stents in acute coronary syndrome ( ACS ) .


The aim of our study was to evaluate the completeness of neointimal coverage with optical coherence tomography ( OCT ) in ACS patients treated with drug-eluting stents ( DES ) comparing EES versus new-generation ZES-R .


All eligible ACS patients admitted to four Italian centres with a clinical indication for culprit lesion intervention were randomised 1:1 to EES or ZES-R .


The primary study endpoint was the percentage of uncovered stent struts evaluated by optical coherence tomography ( OCT ) at six months .


Secondary endpoints were the percentage of malapposed stent struts , percent neointimal hyperplasia cross-sectional area ( CSA ) and major adverse cardiac events ( MACE ) at six months .


A total of 60 patients were randomised to EES ( n = 29 ) or ZES-R ( n = 31 ) .


No differences were observed in baseline characteristics between the two groups .


Overall , 31.7 % presented with STEMI , of which 68.4 % were anterior .


The other patients comprised 41.7 % NSTEMI and 26.7 % troponin-negative ACS .


A mean of 1.30.6 lesions were treated per patient , with a mean of 1.30.5 stents per lesion .


At 30 days there was one sudden death .


Six-month OCT analysis was performed in 25 lesions in the EES group and in 24 lesions in the ZES-R group .


There was no difference in the primary endpoint of uncovered stent struts between groups ( EES 6.42 % [ 3.27 , 9.57 ] vs. ZES-R 7.07 % [ 3.22 , 10.92 ] ; p = 0.80 ) .


Furthermore , there were no differences between groups in the percentage of malapposed stent struts , either with ( EES 1.19 % [ 0.34 , 2.04 ] vs. ZES-R 0.85 % [ 0.40 , 1.30 ] ; p = 0.49 ) or without coverage ( EES 1.06 % [ 0.12 , 2.01 ] vs. ZES-R 0.24 % [ 0.05 , 0.44 ] ; p = 0.09 ) .


Percent neointima CSA was similar in both groups ( EES 37.0 % [ 18.6 , 55.3 ] vs. ZES-R 26.6 % [ 18.4 , 34.8 ] ; p = 0.31 ) .


At six-month clinical follow-up , no additional patients died or suffered MI .


There were four MACE in the EES group and one in the ZES-R group .


In our study , in patients presenting with ACS , both EES and ZES-R had low percentages of malapposed and uncovered stent struts at six-month OCT analysis .


This prospective randomized pilot study reports our institutional experience and early results using Sonoma Wrx ( Sonoma Orthopedic Products , Santa Rosa , CA ) in the treatment of extra-articular and simple intra-articular distal radius fractures .


A total of 64 patients , were enrolled in the study .


They were considered eligible if they had ; unstable extra-articular distal radius fractures and simple intra-articular distal radius fractures suitable for closed reduction ( AO types ; A2 .2 , A2 .3 , A3 .1 C2 .1 , C2 .2 ) .


Patients in group I received intramedullary fixation using the Sonoma Wrx device and patients in group II received standard volar locking plate fixation .


Radiographic criteria of acceptable healing were used for evaluation .


Two groups were similar in terms of baseline characteristics .


Mean time of operation was significantly shorter in Group 1 vs. in group 2 ( 36.817.11 vs. 48.975.9 minutes , p = 0.001 ) .


Time to healing of the fracture was not different between two groups ( 5.451.09 vs. 5.701.04 weeks for Group 1 vs. 2 , respectively p = 0.36 ) .


Overall complications occurred in 9 patients in group 1 and in 15 patients in group 2 ( p = 0.17 ) .


Follow-up was completed in all patients with a median time of 12 months and 13 months in group 1 and 2 , respectively .


On radiographic evaluation radial inclination , radial height and volar tilt were not significantly different between group 1 and 2 , respectively .


There were no significant differences between two groups in regard to wrist rotational degrees measured in last follow-up visit .


Sonoma Wrx Device is reliable and effective in terms of achieving satisfactory outcomes in treatment of distal radius fractures .


It may be reasonable to use this device to prevent complications that are related to extensive soft tissue dissection .


RAS is dysregulated in neurofibromatosis type 1 ( NF1 ) related plexiform neurofibromas ( PNs ) .


The activity of tipifarnib , which blocks RAS signaling by inhibiting its farnesylation , was tested in children and young adults with NF1 and progressive PNs .


Patients aged 3-25 years with NF1-related PNs and imaging evidence of tumor progression were randomized in a double-blinded fashion to receive tipifarnib ( 200 mg/m ( 2 ) orally every 12 h ) or placebo ( phase A ) and crossed over to the opposite treatment arm at the time of tumor progression ( phase B ) .


PN volumes were measured with MRI , and progression was defined as 20 % volume increase .


Time to progression ( TTP ) in phase A was the primary endpoint , and the trial was powered to detect whether tipifarnib doubled TTP compared with placebo .


Toxicity , response , and quality of life were also monitored .


Sixty-two patients were enrolled .


Tipifarnib and placebo were well tolerated .


On phase A , the median TTP was 10.6 months on the placebo arm and 19.2 months on the tipifarnib arm ( P = .12 ; 1-sided ) .


Quality of life improved significantly compared with baseline on the tipifarnib arm but not on the placebo arm .


Volumetric tumor measurement detected tumor progression earlier than conventional 2-dimensional ( WHO ) and 1-dimensional ( RECIST ) methods .


Tipifarnib was well tolerated but did not significantly prolong TTP of PNs compared with placebo .


The randomized , flexible crossover design and volumetric PN assessment provided a feasible and efficient means of assessing the efficacy of tipifarnib .


The placebo arm serves as an historical control group for phase 2 single-arm trials directed at progressive PNs .


To determine whether a midwife-led intervention improved preparation for twin parenting and maternal psychosocial outcome .


Randomised controlled trial .


Two maternity units in North East England .


A cohort of 162 women with uncomplicated twin pregnancy .


Self-completion questionnaire at multiple time points .


The primary outcome was probable postnatal depression ( measured with the Edinburgh Postnatal Depression Scale , EPDS ) 26 weeks after delivery .


Secondary outcomes included preparation for parenting , maternal anxiety , parenting stress , and maternal wellbeing .


The mean maternal EPDS scores at 26 weeks after delivery were 5.4 ( SD 4.5 ) in the twin intervention ( TI ) group and 6.9 ( SD 5.5 ) in the twin control ( TC ) group , and the mean difference between the groups was 1.5 ( 95 % confidence interval , 95 % CI , -0.2 to 3.3 ) .


The relative risk ( RR ) of having probable depression in the TI group compared with the TC group at 26 weeks was 0.48 ( 95 % CI 0.19-1 .20 ) for mothers and 0.84 ( 95 % CI 0.42-1 .70 ) for fathers .


There were no statistically significant differences in maternal anxiety or parenting stress .


TI mothers reported increased maternal wellbeing , reaction to motherhood , family support , mood , and greater self-confidence 26 weeks after delivery , and felt more prepared for parenting .


As a result of the limited sample size , the study was unable to detect a difference in maternal depression using the maternal EPDS mean score .


The antenatal preparation for parenting programme did not improve postnatal maternal anxiety or parenting stress ; however , it did improve postnatal maternal wellbeing , mood , self-confidence , reaction to motherhood , and better prepared mothers to parent twin infants .


Midwives have a key role in preparing mothers to parent twins .


Prior studies suggest that elevated markers of bone turnover are prognostic for poor survival in castration-resistant prostate cancer ( CRPC ) .


The predictive role of these markers relative to bone-targeted therapy is unknown .


We prospectively evaluated the prognostic and predictive value of bone biomarkers in sera from CRPC patients treated on a placebo-controlled phase III trial of docetaxel with or without the bone targeted endothelin-A receptor antagonist atrasentan ( SWOG S0421 ) .


Markers for bone resorption ( N-telopeptide and pyridinoline ) and formation ( C-terminal collagen propeptide and bone alkaline phosphatase ) were assayed in pretreatment and serial sera .


Cox proportional hazards regression models were fit for overall survival .


Models were fit with main effects for marker levels and with/without terms for marker-treatment interaction , adjusted for clinical variables , to assess the prognostic and predictive value of atrasentan .


Analysis was adjusted for multiple comparisons .


Two-sided P values were calculated using the Wald test .


Sera from 778 patients were analyzed .


Elevated baseline levels of each of the markers were associated with worse survival ( P < .001 ) .


Increasing marker levels by week nine of therapy were also associated with subsequent poor survival ( P < .001 ) .


Patients with the highest marker levels ( upper 25th percentile for all markers ) not only had a poor prognosis ( hazard ratio [ HR ] = 4.3 ; 95 % confidence interval [ CI ] = 2.41 to 7.65 ; P < .001 ) but also had a survival benefit from atrasentan ( HR = 0.33 ; 95 % CI = 0.15 to 0.71 ; median survival = 13 [ atrasentan ] vs 5 months [ placebo ] ; P interaction = .005 ) .


Serum bone metabolism markers have statistically significant independent prognostic value in CRPC .


Importantly , a small group of patients ( 6 % ) with highly elevated markers of bone turnover appear to preferentially benefit from atrasentan therapy .


Limited data exist concerning outcomes of patients with non-ST-segment elevation acute coronary syndromes ( NSTE ACS ) with no angiographically obstructive coronary artery disease ( non-obstructive CAD ) .


We assessed the frequency of clinical outcomes among patients with non-obstructive CAD compared with obstructive CAD .


We pooled data from eight NSTE ACS randomized clinical trials from 1994 to 2008 , including 37,101 patients who underwent coronary angiography .


The primary outcome was 30-day death or myocardial infarction ( MI ) .


Adjusted odds ratios ( ORs ) and 95 % confidence intervals ( CIs ) for 30-day death or MI for non-obstructive versus obstructive CAD were generated for each trial .


Summary ORs ( 95 % CIs ) across trials were generated using random effects models .


Overall , 3550 patients ( 9.6 % ) had non-obstructive CAD .


They were younger , more were female , and fewer had diabetes mellitus , previous MI or prior percutaneous coronary intervention than patients with obstructive CAD .


Thirty-day death or MI was less frequent among patients with non-obstructive CAD ( 2.2 % ) versus obstructive CAD ( 13.3 % ) ( OR ( adj ) 0.15 ; 95 % CI , 0.11-0 .20 ) ; 30-day death or spontaneous MI and six-month mortality were also less frequent among patients with non-obstructive CAD ( OR ( adj ) 0.19 ( 0.14-0 .25 ) and 0.37 ( 0.28-0 .49 ) , respectively ) .


Among patients with NSTE ACS , one in 10 had non-obstructive CAD .


Death or MI occurred in 2.2 % of these patients by 30 days .


Compared with patients with obstructive CAD , the rate of major cardiac events was lower in patients with non-obstructive CAD but was not negligible , prompting the need to better understand management strategies for this group .


The week 48 primary analysis of the ENCORE1 trial established the virological non-inferiority and safety of efavirenz 400 mg compared with the standard 600 mg dose , combined with tenofovir and emtricitabine , as first-line HIV therapy .


This 96-week follow-up of the trial assesses the durability of efficacy and safety of this treatment over 96 weeks .


ENCORE1 was a double-blind , placebo-controlled , non-inferiority trial done at 38 clinical sites in 13 countries .


HIV-infected adult patients ( 16 years of age ) with no previous antiretroviral therapy , a CD4 cell count of 50-500 cells per L , and plasma HIV-1 viral load of at least 1000 copies per mL were randomly assigned ( 1:1 ) by an electronic case report form to receive fixed-dose daily tenofovir 300 mg and emtricitabine 200 mg plus efavirenz either 400 mg daily or 600 mg daily .


Participants , physicians , and all other trial staff were masked to treatment assignment .


Randomisation was stratified by HIV-1 viral load at baseline ( or > 100000 copies per mL ) .


The primary endpoint was the difference in the proportions of patients in the two treatment groups with a plasma HIV-1 viral load below 200 copies per mL at week 96 .


Treatment groups were deemed to be non-inferior if the lower limit of the 95 % CI for the difference in viral load was above -10 % by modified intention-to-treat analysis .


Non-inferiority was assessed in the modified intention-to-treat , per-protocol , and non-completer = failure ( NC = F ) populations .


Adverse events and serious adverse events were summarised by treatment group .


This study is registered with ClinicalTrials.gov , number NCT01011413 .


Between Aug 24 , 2011 , and March 19 , 2012 , 636 eligible participants were enrolled and randomly assigned to the two treatment groups ( 324 to efavirenz 400 mg and 312 to efavirenz 600 mg ) .


The intention-to-treat population who received at least one dose of study drug comprised 630 patients : 321 in the efavirenz 400 mg group and 309 in the efavirenz 600 mg group .


585 patients ( 93 % ; 299 in the efavirenz 400 mg group and 286 in the 600 mg group ) completed 96 weeks of follow-up .


At 96 weeks , 289 ( 900 % ) of 321 patients in the efavirenz 400 mg group and 280 ( 906 % ) of 309 in the efavirenz 600 mg group had a plasma HIV-1 viral load less than 200 copies per mL ( difference -06 , 95 % CI -52 to 40 ; p = 072 ) , which suggests continued non-inferiority of the lower efavirenz dose .


Non-inferiority was recorded for thresholds of less than 50 and less than 400 copies per mL , irrespective of baseline plasma viral load .


Adverse events were reported by 291 ( 91 % ) of 321 patients in the efavirenz 400 mg group and by 285 ( 92 % ) of 309 in the 600 mg group ( p = 048 ) .


The proportions of patients reporting an adverse event that was definitely or probably related to efavirenz were 126 ( 39 % ) for efavirenz 400 mg and 148 ( 48 % ) for efavirenz 600 mg ( p = 003 ) .


The number of patients who reported serious adverse events did not differ between the groups ( p = 020 ) .


Our findings confirm that efavirenz 400 mg is non-inferior to the standard dose of 600 mg in combination with tenofovir and emtricitabine as initial HIV therapy over 96 weeks .


Fewer efavirenz-related adverse events were reported with the 400 mg efavirenz dose than with the 600 mg dose .


These findings support the routine use of efavirenz 400 mg .


The coadministration of rifampicin and efavirenz 400 mg needs further investigation .


Bill & Melinda Gates Foundation , and UNSW Australia .


Overnight hypoglycemia occurs frequently in individuals with type 1 diabetes and can result in loss of consciousness , seizure , or even death .


We conducted an in-home randomized trial to determine whether nocturnal hypoglycemia could be safely reduced by temporarily suspending pump insulin delivery when hypoglycemia was predicted by an algorithm based on continuous glucose monitoring ( CGM ) glucose levels .


Following an initial run-in phase , a 42-night trial was conducted in 45 individuals aged 15-45 years with type 1 diabetes in which each night was assigned randomly to either having the predictive low-glucose suspend system active ( intervention night ) or inactive ( control night ) .


The primary outcome was the proportion of nights in which 1 CGM glucose values 60 mg/dL occurred .


Overnight hypoglycemia with at least one CGM value 60 mg/dL occurred on 196 of 942 ( 21 % ) intervention nights versus 322 of 970 ( 33 % ) control nights ( odds ratio 0.52 [ 95 % CI 0.43-0 .64 ] ; P < 0.001 ) .


Median hypoglycemia area under the curve was reduced by 81 % , and hypoglycemia lasting > 2 h was reduced by 74 % .


Overnight sensor glucose was > 180 mg/dL during 57 % of control nights and 59 % of intervention nights ( P = 0.17 ) , while morning blood glucose was > 180 mg/dL following 21 % and 27 % of nights , respectively ( P < 0.001 ) , and > 250 mg/dL following 6 % and 6 % , respectively .


Morning ketosis was present < 1 % of the time in each arm .


Use of a nocturnal low-glucose suspend system can substantially reduce overnight hypoglycemia without an increase in morning ketosis .


Male clients of female sex workers ( FSWs ) are at risk of HIV and other sexually transmitted infections ( STIs ) .


We conducted a two-arm randomized controlled trial to test the efficacy of a sexual risk reduction intervention for male clients of FSWs in Tijuana , Mexico .


Male clients of FSWs who were at least 18 , were HIV-negative at baseline , and reported recent unprotected sex with FSWs were randomized to the Hombre Seguro sexual risk reduction intervention , or a time-attention didactic control condition .


Each condition lasted approximately one hour .


Participants underwent interviewer-administered surveys and testing for HIV and other STIs at baseline , and at 4 , 8 , and 12month follow-ups .


Combined HIV/STI incidence and unprotected vaginal and anal sex acts with FSWs were the primary outcomes .


A total of 400 participants were randomized to one of the two conditions .


Analyses indicated that randomization was successful ; there were no significant differences between the participants in the two conditions at baseline .


Average follow-up was 84 % across both conditions .


This is the first study to test the efficacy of a sexual risk reduction intervention for male clients of FSWs using the rigor of a randomized controlled trial .


NCT01280838 , Date of registration : January 19 , 2011 .


To determine the clinical performance of DAILIES TOTAL1 ( DT1 ) , Clariti 1Day ( C1D ) , and 1-DAY ACUVUE TruEye ( AVTE ) silicone hydrogel daily disposable contact lenses ( SiHy DDCLs ) .


Eligible participants , subdivided into asymptomatic and symptomatic groups , wore each SiHy DDCLs for three consecutive days .


Each participant attended three visits ( on day 1 at 0 hours ; on days 1 and 3 after 8 hours of wear ) per lens type .


The order of lens wear was randomized , with at least 1 day washout between lenses .


Lens-related performance was evaluated by assessing lens surface deposits , wettability , pre-lens noninvasive tear breakup time , lens movement , and centration ; ocular response assessments included conjunctival redness , corneal staining , and conjunctival staining and indentation .


Fifty-one asymptomatic and 53 symptomatic participants completed the study .


For all visits , the mean noninvasive tear breakup time was about 1 second longer with DT1 than with C1D and AVTE ( p < 0.01 ) .


Overall , the wettability of all three lenses was good ; however , DT1 was graded marginally better than the other lenses ( both p < 0.01 ) .


On day 3 , eyes wearing AVTE had significantly more dehydration-induced corneal staining compared with DT1 ( AVTE , 24 % ; DT1 , 11 % ; p < 0.01 ) .


After 8 hours , conjunctival staining was different between lenses ( greatest with C1D and least with DT1 ; all p < 0.01 ) .


Conjunctival indentation was more prevalent with the C1D lenses ( n = 70 ) compared with DT1 ( n = 1 ; p < 0.01 ) and AVTE ( n = 11 ; p < 0.01 ) .


There were no differences between asymptomatic and symptomatic lens wearers for any of the clinical parameters ( all p > 0.05 ) .


Each of the three SiHy DDCLs performed well .


Noninvasive tear breakup time was longest and wettability was greater with DT1 .


C1D had the most conjunctival staining conjunctival indentation .


There was no difference between asymptomatic and symptomatic wearers with regard to ocular response and contact lens-related parameters .


These results suggest that SiHy DDCLs may be an excellent contact lens modality for the symptomatic patient .


Hydrocarbons , especially kerosene ( paraffin ) , are the most common agents causing childhood poisoning in low and middle income countries ( LMICs ) .


Aspiration of kerosene causes an inflammatory sterile chemical pneumonitis , which may increase susceptibility to secondary lower respiratory tract bacterial infection .


This study aimed to assess the efficacy of prophylactic antibiotics in the management of kerosene-associated pneumonitis in children and to identify risk factors associated with severity or outcome .


A double-blind placebo-controlled trial of prophylactic antibiotics in the management of kerosene-associated pneumonitis of children presenting to a referral hospital was performed from July 2010 to September 2011 .


Sequential children with a history of kerosene ingestion and mild respiratory illness were randomised to receive placebo or amoxicillin .


Each child was followed-up at Day 3 and Day 5 post-ingestion .


The primary outcome measure was the number of treatment failures in each group , defined as any child who deteriorated within this time , necessitating a change in treatment regimen .


Secondary outcome measures were length of hospital stay and symptoms and signs at follow-up .


Seventy-four patients were enrolled .


Thirty-five ( 47 % ) received placebo and 39 ( 53 % ) active treatment .


There was no significant difference in treatment failures between placebo ( 3/35 , 9 % ; 95 % CI , 3-22 ) and active ( 2/39 , 5 % ; 95 % CI , 1-17 ) groups ( relative risk , 0.60 ; 95 % CI , 0.11-3 .37 ) .


The median length of hospital stay was identical ( placebo 0.5 days ; IQR , 0-1 .0 and active 0.5 days ; IQR , 0.5-1 .0 ) .


Symptoms and signs at Days 3 and 5 post-ingestion were similar .


The only significant risk factor for treatment failure was residence in formal housing .


Clinical severity at presentation was similar for treatment successes and failures .


Prophylactic antibiotics do not improve the outcome in children with mild respiratory illness after kerosene ingestion .


To discuss the role of carbon nanoparticles in the protection of parathyroid during thyroid carcinoma surgery .


Seventy-two patients with thyroid carcinoma who had initial surgery were randomly divided into two groups : carbon nanoparticles group and the control group .


Emulsion of carbon nanoparticles was injected into the thyroid gland of carbon nanoparticles group patients .


After thirty minutes , the excision of thyroid carcinoma and VI group neck dissection were performed in carbon nanoparticles group patients , the control group directly underwent operation .


The black stained tissue in the dissection specimen of carbon nanoparticles group was separated .


The number of total lymph node , metastasis lymph node and parathyroid gland in the tissure black stained or not in two groups were counted respectively .


There were 312 lymph nodes in the black stained tissue of central compartment dissection specimen of carbon nanoparticles group .


No parathyroid gland was found in the black stained tissue .


Fifteen lymph nodes containing four parathyroid glands were found in the non black stained tissue in carbon nanoparticles group while there were 202 lymph nodes containing 13 parathyroid glands in the control group .


There were statistical difference between the amount of lymph node in black stain tissue and the specimen of the control group .


Parathyroid glands were not stained black , and no parathyroid gland was found in the black-stained tissue .


The carbon nanoparticles could be used to identify the lymph node and the parathyroid gland for protecting the parathyroid gland in thyroid surgery .


Chronic urticaria not responsive to antihistamines is a difficult disease to manage .


Methotrexate has been used in difficult chronic urticarias with some benefit .


To evaluate the efficacy of methotrexate in the treatment of chronic spontaneous urticaria poorly responsive to H1 antihistaminics .


In a randomized double-blind trial at the Department of Dermatology and Venereology of a tertiary care centre , 29 patients with chronic spontaneous urticaria not responding well to H1 antihistaminics were recruited .


Patients were randomly allocated to receive either a weekly dose of oral methotrexate 15 mg or placebo ( calcium carbonate ) for a total duration of 12 weeks , after which treatment was stopped and patients were followed up for relapse of urticaria .


Each group also received levocetrizine 5 mg once daily for symptom control .


Primary outcome measured was a reduction by > 2/3 rd of baseline urticaria scores after 12 week therapy .


Secondary outcome was a reduction in antihistamine requirement after stopping therapy .


Fourteen patients were randomized to the methotrexate group and fifteen patients to the placebo group .


Out of 17 patients who completed therapy , the primary outcome was achieved by 3.5 1.9 ( out of 10 ) patients in the methotrexate group and by 3.67 1.03 ( out of 7 ) patients in the placebo group ( P > 0.05 ) .


Ten patients followed up , after stopping therapy , for a mean period of 3.5 2.4 months ; 3 remained in remission and 7 had relapsed .


One patient had uncontrollable nausea and vomiting after taking methotrexate and was withdrawn from the study .


The placebo group did not experience any side effects .


Methotrexate 15 mg weekly for 3 months did not provide any additional benefit over H1 antihistamines in this study but an adequately powered study with longer follow up is required to assess its utility .


Postoperative continuous positive airway pressure ( CPAP ) can improve lung function .


The aim of our study was to assess the efficacy of prophylactic CPAP on the Pa ( O2 ) / FI ( O2 ) ratio measured the day after surgery in patients undergoing lung resection surgery ( LRS ) .


The study population comprised 110 patients undergoing LRS .


On arrival in the postanaesthesia care unit ( PACU ) , patients were randomized to receive CPAP at 5-7 cm H2O during the first 6 h after surgery ( CPAP group ) or supplemental oxygen through a Venturi mask ( Venturi group ) .


The Pa ( O2 ) / FI ( O2 ) ratio was measured on arrival in the PACU , 7 h after admission , and the day after surgery .


The Pa ( O2 ) / FI ( O2 ) ratio is the primary endpoint of our study .


We also analysed the chest radiograph and assessed the postoperative course .


We then analysed the impact of ventilatory management in the PACU depending on the respiratory risk of the patient .


Baseline characteristics were similar in both groups .


Patients who received CPAP had significantly higher Pa ( O2 ) / FI ( O2 ) at 24 h after surgery compared with patients managed conventionally ( Venturi group ) ( 48.614 vs 42.312 , P = 0.031 ) , but there were no differences at 7 h. On subgroup analysis , we found that the benefits of CPAP were greater in higher risk patients .


The incidence of postoperative pulmonary complications and stay in the PACU and hospital were similar in both groups .


In patients undergoing LRS , prophylactic CPAP during the first 6 h after surgery with a pressure of 5-7 cm H2O improved the Pa ( O2 ) / FI ( O2 ) ratio at 24 h.


This effect was more evident in patients with increased risk of postoperative pulmonary complications .


Maternal obesity and gestational weight gain are linked to offspring adverse metabolic profiles , and lifestyle interventions during pregnancy in obese women may have long-term positive effects on their children .


Furthermore , although the association between birth weight and later metabolic outcomes is well established , little is known about the predictive value of abdominal circumference at birth .


The purpose of this study was to determine ( 1 ) the effects of lifestyle interventions during pregnancy in obese women on offspring metabolic risk factors and ( 2 ) predictive values of birth weight ( BW ) and birth abdominal circumference ( BAC ) .


This was a follow-up of a randomized controlled trial , the Lifestyle in Pregnancy ( LiP ) study .


The study was conducted in Odense and Aarhus University Hospitals , Denmark .


We studied the offspring of LiP study participants ( n = 157 ) and offspring of normal-weight mothers ( external reference group , n = 97 ) .


INTERVENTIONs included dietary advice , coaching , and exercise during pregnancy .


The outcome measures were body mass index ( BMI ) Z-score , abdominal circumference , blood pressure , and fasting plasma glucose , insulin , high-density lipoprotein , and triglycerides at the age of 2.8 years .


No differences were detected in BMI Z-scores or metabolic risk factors between the LiP intervention and control groups or between the LiP and external reference groups .


BAC and BW were associated ( all P < .05 ) with BMI Z-score ( 0.19-0 .23 ) , abdominal circumference ( 0.57-0 .70 ) , plasma glucose ( 0.11-0 .09 ) , insulin ( 4.33-3 .13 ) , and triglycerides ( 0.07-0 .07 ) but not with blood pressure or high-density lipoprotein ( regression coefficients per increase in BAC and BW of 1 SD score ) .


Early childhood metabolic risk factors were unaffected by lifestyle interventions in obese pregnant women .


Offspring of obese mothers who participated in the LiP study were comparable to offspring of normal-weight mothers , possibly indicating a general beneficial effect of trial participation .


BAC and BW were both associated with later metabolic risk factors .


Colorectal cancer screening ( CRCS ) reduces morbidity and mortality ; however , the positive benefits might be partially offset by long-term distress following positive screening results .


We examined relationships among colorectal cancer-specific worry and situational anxiety after positive fecal occult blood tests [ FOBT ( + ) ] compared with receipt of negative results .


Of note , 2,260 eligible members of Group Health , an integrated healthcare delivery system , completed baseline surveys and received FOBT screening kits , with 1,467 members returning the kits .


We matched FOBT ( + ) patients ( n = 55 ) 1:2 on age and sex with FOBT ( - ) respondents ( n = 110 ) .


Both groups completed follow-up surveys at 7 to 14 days and 4 months after screening .


We assessed situational anxiety ( State-Trait Anxiety Inventory , STAI ) , colorectal cancer worry frequency , and mood disturbance .


Mean age was 59 years , and majority were women ( 62 % ) and White ( 89 % ) .


After adjusting for age , sex , and baseline worry , at 7 to 14 days after screening , the FOBT ( + ) group was 3.82 [ 95 % confidence interval ( CI ) , 1.09-13 .43 ] times more likely to report colorectal cancer-related mood disturbances and significantly higher mean STAI scores than the FOBT ( - ) group ( mean = 38.8 vs. 30.9 ; P = 0.007 ) .


At 4-month posttest , mood disturbances and situational anxiety seemed to drop to baseline levels for FOBT ( + ) .


No colon cancer worry frequency was observed .


FOBT ( + ) results are associated with short-term situational anxiety and colorectal cancer-specific mood disturbances .


Distress from FOBT ( + ) results declined to near-baseline levels by 4 months .


Additional studies are needed to clarify the relationship between long-term distress and follow-up colonoscopy .


The purpose of this study was to assess the anti-inflammatory , analgesic and osteogenic early effects of melatonin on post-extraction sockets of patients requiring third molars extraction .


A randomized , triple-blind clinical trial was made using a split-mouth design .


Both lower third molars of 10 patients were extracted and 3 mg of local melatonin or placebo were applied .


Concentrations of interleukin-6 and nitrotyrosine were determined on samples of the clot from the socket by independent ELISA tests .


Radiographic bone density was evaluated by measuring Hounsfield Units in panoramic and cross sections obtained by digital scanner .


Statistical analysis by Kolmogorov-Smirnov test was performed for ELISA data .


Bone density was analyzed by Shapiro-Wilk test .


Subsequently t test was applied .


P < 0.05 was considered to be significant .


The concentration of interleukin-6 increased with the application of melatonin without statistically significance ( 361.32 235.22 pg/ml vs 262.58 233.92 pg/ml ) .


Nitrotyrosine concentrations showed values below to the detectability pattern ( < 0.001 nM ) in Optic Density curve .


Bone density in panoramic sections at socket after melatonin application showed no significant difference ( 561.98 105.92 HU vs 598.82 209.03 HU ) .


In cross sections , bone density in the alveolar region showed no significant difference ( 377.42 125.67 HU vs 347.56 97.02 HU ) .


Within the limitations of this pilot study , no differences with the application of melatonin were found in terms of the concentration of interleukin-6 and bone density in post-extraction socket of retained mandibular third molars .


There is consistent evidence that the binge drinking standard of 5 + drinks per drinking occasion for men ( 4 + for women ) is associated with risk for negative consequences .


Yet , many have questioned the adequacy of this measure as an index of intoxication ( e.g. , a blood alcohol concentration [ BAC ] of 0.08 g % ) .


In response to these concerns , a National Institute on Alcohol Abuse and Alcoholism task force recommended adding a time qualifier of 2hours to this criterion .


Although conceptually appealing , there has been little effort to determine whether this new measure better captures drinking that leads to negative consequences .


This study examined the new binge standard ( 2-hour period ) and old binge standard ( no time qualifier ) in relation to frequency of drinking to an estimated BAC of 0.08 g % and the experience of negative drinking consequences .


These relations were examined within both a social drinking sample of adults ( N = 200 ) and a sample of heavy-drinking young adults ( N = 168 ) participating in a randomized clinical trial for drinking reduction .


Contrary to the purpose of adding a time qualifier , the new binge measure was not more strongly correlated with drinking to an estimated BAC of 0.08 g % relative to the old binge measure .


In addition , when both measures were entered simultaneously into a regression model , only the old binge measure accounted for significant variance in negative drinking consequences .


These empirically based results suggest that the original binge standard without a time qualifier may be preferable to the 2-hour standard as a marker for risk .


The findings also suggest that further efforts are needed to identify a brief measure that effectively captures drinking to intoxication and related risk for negative consequences .


Green tea ( GT ) is able to increase energy expenditure ( EE ) and fat oxidation ( FATox ) via inhibition of catechol-O-methyl transferase ( COMT ) by catechins .


However , this does not always appear unanimously because of large inter-individual variability .


This may be explained by different alleles of the functional COMT Val108/158Met polymorphism that are associated with COMT enzyme activity ; high-activity enzyme , COMT ( H ) ( Val/Val genotype ) , and low-activity COMT ( L ) ( Met/Met genotype ) .


Fourteen Caucasian subjects ( BMI : 22.22.3 kg/m2 , age : 21.42.2 years ) of whom 7 with the COMT ( H ) - genotype and 7 with the COMT ( L ) - genotype were included in a randomized , cross-over study in which EE and substrate oxidation were measured with a ventilated-hood system after decaffeinated GT and placebo ( PL ) consumption .


At baseline , EE , RQ , FATox and carbohydrate oxidation ( CHOox ) did not differ between groups .


Significant interactions were observed between COMT genotypes and treatment for RQ , FATox and CHOox ( p < 0.05 ) .


After GT vs. PL , EE ( GT : 62.2 vs. PL : 35.4 kJ .3.5 hrs ; p < 0.01 ) , RQ ( GT : 0.80 vs. PL : 0.83 ; p < 0.01 ) , FATox ( GT : 18.3 vs. PL : 15.3 g/d ; p < 0.001 ) and CHOox ( GT : 18.5 vs. PL : 24.3 g/d ; p < 0.001 ) were significantly different for subjects carrying the COMT ( H ) genotype , but not for subjects carrying the COMT ( L ) genotype ( EE , GT : 60.3 vs. PL : 51.7 kJ .3.5 hrs ; NS ) , ( RQ , GT : 0.81 vs. PL : 0.81 ; NS ) , ( FATox , GT : 17.3 vs. PL : 17.0 g/d ; NS ) , ( CHOox , GT : 22.1 vs. PL : 21.4 g/d ; NS ) .


Subjects carrying the COMT ( H ) genotype increased energy expenditure and fat-oxidation upon ingestion of green tea catechins vs , placebo , whereas COMT ( L ) genotype carriers reacted similarly to GT and PL ingestion .


The differences in responses were due to the different responses on PL ingestion , but similar responses to GT ingestion , pointing to different mechanisms .


The different alleles of the functional COMT Val108/158Met polymorphism appear to play a role in the inter-individual variability for EE and FATox after GT treatment .


Nederlands Trial register NTR1918 .


Caudal analgesia has been prolonged by the addition of various adjuvants .


Dexmedetomidine is a highly selective alpha-2 agonist with sedative and analgesic properties .


To investigate the effect of addition of dexmedetomidine to 0.25 % bupivacaine for caudal analgesia in children undergoing major abdominal cancer surgery .


A randomized double-blind trial .


Academic medical center .


Forty pediatric patients , aged 3 - 12 years , weighting 10 - 40 kg , and of American Society of Anesthesiologists ( ASA ) physical status I and II scheduled for major abdominal cancer surgeries under general anesthesia combined with caudal analgesia were enrolled .


They were randomly allocated into 2 groups : Group I ( BD ) : ( n = 20 ) received 1 mL/kg bupivacaine 0.25 % with dexmedetomidine 1 g/kg and group II ( B ) : ( n = 20 ) received 1 mL/kg bupivacaine 0.25 % .


Heart rate ( HR ) , mean arterial pressure ( MAP ) , and oxygen saturation ( SPO2 ) were recorded for 120 minutes .


Pain was assessed immediately postoperative and at hours 2 , 4 , 6 , 12 , 18 , and 24 of postoperative period by Face , Legs , Activity , Cry and Consolability ( FLACC ) score .


Time to first request for analgesia and total analgesic consumption in the first 24 hours were recorded .


The level of sedation was recorded using Ramsay 's sedation scale [ Intravenous acetaminophen 15mg/kg ( perfalgan , Squibb ) ] .


Adverse effects were recorded and treated .


There was significant reduction in FLACC score in group BD at 2 , 4 , 6 , and 12 hours postoperatively compared to group B.


At the eighteenth and twenty-fourth hour there was no significant difference .


Time of the first rescue analgesic requirement was significantly prolonged in group BD compared to group B.


The mean total consumption of rescue analgesia in the 24 hours of the postoperative period was significantly decreased in group BD ( 405.00 215.03 ) mg when compared with group B ( 810.35 200.93 ) mg .


This study is limited by its small sample size .


Addition of dexmedetomidine ( 1 g/kg ) to caudal bupivacaine 0.25 % ( 1 mL/kg ) in pediatric major abdominal cancer surgeries achieved significant postoperative pain relief for up to 19 hours , with less use of postoperative analgesics , and prolonged duration of arousable sedation .


Hemodynamic changes were statistically significant , yet of no clinical significance .


To develop a mapping algorithm for estimating EuroQol five-dimensional ( EQ-5D ) questionnaire values from the prostate cancer-specific health-related quality-of-life ( HRQOL ) instrument Functional Assessment of Cancer Therapy-Prostate ( FACT-P ) instrument .


The EQ-5D questionnaire and FACT-P instrument data were collected for a subset of patients with metastatic castration-resistant prostate cancer in a multicenter , randomized , double-blind , placebo-controlled phase 3 trial .


We compared three statistical techniques to estimate patients ' EQ-5D questionnaire index scores determined by using the UK tariff : 1 ) generalized estimating equations , 2 ) two-part model combining logistic regression and generalized estimating equation , and 3 ) separate mapping algorithms for patients with poor health defined as a FACT-P score of 76 or less ( group-specific model ) .


Four different sets of explanatory variables were compared .


The models were cross-validated by using a 10-fold in-sample cross-validation .


Values for both instruments were available for 236 patients with metastatic castration-resistant prostate cancer .


The group-specific model including the FACT-P subscale scores and baseline variables had the best predictive performance with R ( 2 ) 0.718 , root mean square error 0.162 , and mean absolute error 0.117 .


The two-part model and the generalized estimating equation model including the FACT-P subdomain scores and baseline variables also had good predictive performance .


The developed algorithms for mapping the FACT-P instrument to the EQ-5D questionnaire enable the estimation of preference-based health-related quality-of-life scores for use in cost-effectiveness analyses when directly elicited EQ-5D questionnaire data are missing .


Very-low-birth-weight ( VLBW ) infants are dependent on parenteral nutrition after birth .


A parenteral lipid emulsion with a multicomponent composition may improve growth and neurodevelopment and may prevent liver injury , which is often observed in association with long-term parenteral nutrition with pure soybean oil .


Our aim was to evaluate the safety and efficacy of a multicomponent lipid emulsion containing 30 % soybean oil , 30 % medium-chain triacylglycerol , 25 % olive oil , and 15 % fish oil compared with a conventional pure soybean oil emulsion in VLBW infants .