From April 12 , 2007 , to Aug 19 , 2010 , in Italy , and from Jan 30 , 2009 , to Jan 10 , 2012 , in France , 121 patients with CJD were enrolled in the study , 62 of whom were randomly assigned to the treatment group and 59 to the placebo group .


The first interim analysis showed absence of superiority of doxycycline compared with placebo , and the trial was stopped for futility .


Efficacy analyses did not show significant differences between patients treated with doxycycline and placebo with regard to survival times ( HR 1.1 , 95 % CI 0.8-1 .7 , p = 0.50 ) .


Serious adverse events were judged not to be related to treatment , whereas a relation was deemed probable or possible for five non-serious adverse events that occurred in each treatment group .


Doxycycline at a dose of 100 mg per day was well tolerated but did not significantly affect the course of CJD , at variance with the results of previous observational studies .


Our experience could be useful in the design of large multinational controlled trials of potential anti-prion molecules in this rare disease .


Agenzia Italiana Farmaco , Italian Ministry of Health , AIEnP , and French Ministry of Health .


The prevalence of sexual dysfunction , low vitality , and poor physical function increases with aging , as does the prevalence of low total and free testosterone ( TT and FT ) levels .


However , the relationship between sex hormones and age-related alterations in older men is not clear .


To test the hypotheses that baseline serum TT , FT , estradiol ( E2 ) , and sex hormone-binding globulin ( SHBG ) levels are independently associated with sexual function , vitality , and physical function in older symptomatic men with low testosterone levels participating in the Testosterone Trials ( TTrials ) .


Cross-sectional study of baseline measures in the TTrials .


The study was conducted at 12 sites in the United States .


The 788 TTrials participants were 65 years and had evidence of sexual dysfunction , diminished vitality , and/or mobility disability , and an average of two TT < 275 ng/dL .


None .


Question 4 of Psychosocial Daily Questionnaire ( PDQ-Q4 ) , the FACIT-Fatigue Scale , and the 6-minute walk test .


Baseline serum TT and FT , but not E2 or SHBG levels had small , but statistically significant associations with validated measures of sexual desire , erectile function , and sexual activity .


None of these hormones was significantly associated within or across trials with FACIT-Fatigue , PHQ-9 Depression or Physical Function-10 scores , or gait speed .


FT and TT levels were consistently , independently , and positively associated , albeit to a small degree , with measures of sexual desire , erectile function , and sexual activity , but not with measures of vitality or physical function in symptomatic older men with low T who qualified for the TTrials .


Biopure MTAD , a new root canal irrigant has shown promising results against the most common resistant microorganism , E. faecalis , in permanent teeth .


However , there is lack of studies comparing its antimicrobial effectiveness with NaOCl in primary teeth .


The purpose of this study was to compare the in vivo antimicrobial efficacy of NaOCl 2.5 % and Biopure MTAD against E. faecalis in primary teeth .


Forty non vital single rooted primary maxillary anterior teeth of children aged 4-8 years , were irrigated either with NaOCl 2.5 % ( n = 15 ) , Biopure MTAD ( n = 15 ) and 0.9 % Saline ( n = 10 , control group ) .


Paper point samples were collected at baseline ( S1 ) and after chemomechanical preparation ( S2 ) during the pulpectomy procedure .


The presence of E. faecalis in S1 & S2 was evaluated using Real time Polymerase Chain Reaction .


Statistical significant difference was found in the antimicrobial efficacy of NaOCl 2.5 % and BioPure MTAD when compared to saline ( p > 0.05 ) .


However , no statistical significant difference was found between the efficacies of both the irrigants .


NaOCl 2.5 % and BioPure MTAD , both irrigants are equally efficient against E. faecalis in necrotic primary anterior teeth .


MTAD is a promising irrigant , however clinical studies are required to establish it as ideal root canal irrigant in clinical practice .


To compare 24-month pulp health outcomes of partial caries removal ( PCR ) and total caries removal ( TCR ) with composite restoration in primary molars .


48 children aged 3-8 years with at least one molar with a deep carious lesion were included .


120 teeth were randomized to control ( TCR ; n = 54 ; 69 % class II ) and test ( PCR ; n = 66 ; 63 % class II ) groups .


Total absence of carious tissue was confirmed using a blunt-tipped probe in the TCR group .


For PCR , excavation was stopped when hardened , dried dentin with a leathery consistency was achieved .


Pulpotomy was performed in cases of pulp exposure .


Pulp exposure occurred in 2 and 27.5 % of teeth treated with PCR and TCR , respectively ( p < 0.01 ) .


The operative time was significantly higher for TCR than PCR .


Success rates were 92 and 96 % in the PCR and TCR groups , respectively ( p = 0.34 ) .


The success rate tended to be lower in occlusoproximal ( 92 % ) than in occlusal ( 100 % ) lesions ( p = 0.08 ) .


The clinical and radiographic success rates of PCR and TCR in primary teeth with deep carious lesions were high and did not differ significantly , indicating that PCR is a reliable minimally invasive approach in primary teeth and that the retention of carious dentin does not interfere with pulp vitality .


Moreover , PCR provided other clinically relevant advantages over TCR , especially lower incidence of pulp exposure and lower operative time .


To determine whether maternal allopurinol treatment during suspected fetal hypoxia would reduce the release of biomarkers associated with neonatal brain damage .


A randomised double-blind placebo controlled multicentre trial .


We studied women in labour at term with clinical indices of fetal hypoxia , prompting immediate delivery .


Delivery rooms of 11 Dutch hospitals .


When immediate delivery was foreseen based on suspected fetal hypoxia , women were allocated to receive allopurinol 500 mg intravenous ( ALLO ) or placebo intravenous ( CONT ) .


Primary endpoint was the difference in cord S100 , a tissue-specific biomarker for brain damage .


222 women were randomised to receive allopurinol ( ALLO , n = 111 ) or placebo ( CONT , n = 111 ) .


Cord S100 was not significantly different between the two groups : 44.5 pg/mL ( IQR 20.2-71 .4 ) in the ALLO group versus 54.9 pg/mL ( IQR 26.8-94 .7 ) in the CONT group ( difference in median -7.69 ( 95 % CI -24.9 to 9.52 ) ) .


Post hoc subgroup analysis showed a potential treatment effect of allopurinol on the proportion of infants with a cord S100 value above the 75th percentile in girls ( ALLO n = 5 ( 12 % ) vs CONT n = 10 ( 31 % ) ; risk ratio ( RR ) 0.37 ( 95 % CI 0.14 to 0.99 ) ) but not in boys ( ALLO n = 18 ( 32 % ) vs CONT n = 15 ( 25 % ) ; RR 1.4 ( 95 % CI 0.84 to 2.3 ) ) .


Also , cord neuroketal levels were significantly lower in girls treated with allopurinol as compared with placebo treated girls : 18.0 pg/mL ( 95 % CI 12.1 to 26.9 ) in the ALLO group versus 32.2 pg/mL ( 95 % CI 22.7 to 45.7 ) in the CONT group ( geometric mean difference -16.4 ( 95 % CI -24.6 to -1.64 ) ) .


Maternal treatment with allopurinol during fetal hypoxia did not significantly lower neuronal damage markers in cord blood .


Post hoc analysis revealed a potential beneficial treatment effect in girls .


NCT00189007 , Dutch Trial Register NTR1383 .


This randomized trial evaluated the therapeutic effect of emotional awareness training on the severity and frequency of pain in patients with irritable bowel syndrome ( IBS ) .


Patients ' level of alexithymia was also measured .


The study involved 100 patients diagnosed with IBS according to the Rome-III criteria .


Patients ' mean age was 34.98 years ( standard deviation 10.22 years ) and 60 % of the patients were female .


Seventy eligible patients were assigned randomly to one of two treatment groups .


One group received standard symptom-oriented medical treatment only ( MT group ) , while the second group , termed the emotional awareness group ( EMT ) , was educated to increase conscious awareness of eight primary emotions in addition to receiving standard symptom-oriented medical treatment .


This study was conducted over 20 months .


All patients received 5 weeks of symptom-oriented medical treatment ; patients in the EMT group also had two emotion awareness training sessions and recorded their emotions in a daily diary .


Sixty patients completed the study .


Patients with IBS scored significantly higher on all aspects of alexithymia compared with healthy controls .


The severity of pain decreased significantly in both groups , with a larger percentage of the patients in the EMT group who completed the study having a significant decrease in pain ( 54 % in the EMT group vs. 36 % in the MT group ) ; this finding was replicated in an intent-to-treat analysis .


The same results were observed for frequency of pain in patients who completed the study ( 59 % in the EMT group vs 43.4 % in the MT group ) , but this finding was not replicated in an intent-to-treat analysis .


These patterns were not influenced by level of alexithymia , age , or gender .


Adding emotional awareness training to medical treatment resulted in a better therapeutic response in abdominal pain in patients with IBS .


Despite therapeutic advances , many people with type 1 diabetes are still unable to achieve optimal glycaemic control , limited by the occurrence of hypoglycaemia .


The objective of the present study is to determine the effectiveness of day and night home closed-loop over the medium term compared with sensor-augmented pump therapy in adults with type 1 diabetes and suboptimal glycaemic control .


The study will adopt an open label , three-centre , multinational , randomised , two-period crossover study design comparing automated closed-loop glucose control with sensor augmented insulin pump therapy .


The study will aim for 30 completed participants .


Eligible participants will be adults ( 18years ) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control ( glycated haemoglobin ( HbA1c ) 7.5 % ( 58mmol/mmol ) and 10 % ( 86mmol/mmol ) ) .


Following a 4-week optimisation period , participants will undergo a 3-month use of automated closed-loop insulin delivery and sensor-augmented pump therapy , with a 4-6week washout period in between .


The order of the interventions will be random .


All analysis will be conducted on an intention to treat basis .


The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/L based on continuous glucose monitoring levels during the 3months free living phase .


Secondary outcomes include HbA1c changes ; mean glucose and time spent above and below target glucose levels .


Further , participants will be invited at baseline , midpoint and study end to participate in semistructured interviews and complete questionnaires to explore usability and acceptance of the technology , impact on quality of life and fear of hypoglycaemia .


Ethical approval has been obtained at all sites .


Before screening , all participants will be provided with oral and written information about the trial .


The study will be disseminated by peer-review publications and conference presentations .


NCT01961622 ( ClinicalTrials.gov ) .


Evaluating the impact of splitting toric power on patient tolerance to misorientation such as with intraocular lens rotation .


University vision clinic .


Healthy , non astigmats had +1.50 D astigmatism induced with spectacle lenses at 90 , 135 , 180 and +3.00 D at 90 .


Two correcting cylindrical lenses of the opposite sign and half the power each were subsequently added to the trial frame misaligned by 0 , 5 or 10 in a random order and misorientated from the initial axis in a clockwise direction by up to 15 in 5 steps .


A second group of adapted astigmats with between 1.00 and 3.00 DC had their astigmatism corrected with two toric spectacle lenses of half the power separated by 0 , 5 or 10 and misorientated from the initial axis in both directions by up to 15 in 5 steps .


Distance , high contrast visual acuity was measured using a computerised test chart at each lens misalignment and misorientation .


Misorientation of the split toric lenses caused a statistically significant drop in visual acuity ( F = 70.341 ; p < 0.001 ) .


Comparatively better acuities were observed around 180 , as anticipated ( F = 3.775 ; p = 0.035 ) .


Misaligning the split toric power produced no benefit in visual acuity retention with axis misorientation when subjects had astigmatism induced with a low ( F = 2.190 , p = 0.129 ) or high cylinder ( F = 0.491 , p = 0.617 ) or in the adapted astigmats ( F = 0.120 , p = 0.887 ) .


Misalignment of toric lens power split across the front and back lens surfaces had no beneficial effect on distance visual acuity , but also no negative effect .


This study investigated whether hormones and pain perception are associated with exam anxiety , and also whether exam anxiety is affected by seasonal differences in testosterone and cortisol levels .


Forty-six healthy males were recruited from a medical college .


Anxiety was induced by having participants perform the Objective Structured Clinical Examination .


Pressure was applied to the participants to induce pain .


Pain thresholds , pain ratings , anxiety ratings , blood pressure , heart rate , salivary testosterone and cortisol levels were measured under resting and anxiety conditions in the spring and summer .


Data were collected from 46 participants during the spring ( n = 25 ) and summer ( n = 21 ) .


Pain thresholds and testosterone levels were significantly lower under anxiety than at rest for all participants ( n = 46 ) , while cortisol levels , pain ratings , and anxiety ratings were significantly higher under anxiety than at rest .


In the spring ( n = 25 ) , testosterone levels were significantly higher at rest than under anxiety , while there was no difference in cortisol levels between resting and anxiety conditions .


In the summer ( n = 21 ) , cortisol levels were significantly higher under anxiety than at rest , while there was no difference in testosterone levels between resting and anxiety conditions .


There were no significant seasonal differences in pain and anxiety ratings and pain threshold .


These results indicate that seasonal differences in testosterone and cortisol levels under anxiety and at rest may affect pain responses .


These results also suggest that acute clinical pain may be relieved by managing anxiety that is related to a decrease of testosterone in spring and a large increase of cortisol in summer .


QVA149 is a once-daily ( o.d. ) inhaled dual bronchodilator containing a fixed-dose combination of the long-acting 2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium for the treatment of COPD .


The QUANTIFY study compared QVA149 with a free-dose bronchodilator combination of tiotropium plus formoterol ( TIO+FOR ) in improving health-related quality of life ( HRQoL ) of patients with COPD .


This multicentre , blinded , triple-dummy , parallel-group , non-inferiority study randomised patients aged 40years with moderate-to-severe COPD ( post-bronchodilator forced expiratory volume in 1s ( FEV1 ) 30 % to < 80 % predicted ) to QVA149 110/50g o.d. or TIO 18g o.d. + FOR 12g twice daily ( 1:1 ) for 26weeks .


The primary endpoint was to demonstrate non-inferiority in HRQoL assessed using St George 's Respiratory Questionnaire-COPD ( SGRQ-C ) .


The prespecified non-inferiority margin was 4 units .


Secondary endpoints included Transition Dyspnoea Index ( TDI ) score , pre-dose FEV1 , forced vital capacity ( FVC ) and safety .


Of the 934 patients randomised ( QVA149 = 476 and TIO+FOR = 458 ) , 87.9 % completed the study .


At week 26 , non-inferiority was met for SGRQ-C ( QVA149 vs TIO+FOR ; difference : -0.69 units ; 95 % CI -2.31 to 0.92 ; p = 0.399 ) .


A significantly higher percentage of patients achieved a clinically relevant 1 point improvement in TDI total score with QVA149 ( 49.6 % ) versus TIO+FOR ( 42.4 % ; p = 0.033 ) .


QVA149 significantly increased pre-dose FEV1 ( +68 mL , 95 % CI 37mL to 100mL ; p < 0.001 ) and FVC ( +74 mL , 95 % CI 24mL to 125mL ; p = 0.004 ) compared with TIO+FOR at week 26 .


The incidence of adverse events was comparable between both treatments ( QVA149 = 43.7 % and TIO+FOR = 42.6 % ) .


QVA149 is non-inferior to TIO+FOR in improving HRQoL , with clinically meaningful and significant improvements in breathlessness and lung function in patients with COPD .


NCT01120717 .


Tuberculosis regimens that are shorter and simpler than the current 6-month daily regimen are needed .


We randomly assigned patients with newly diagnosed , smear-positive , drug-sensitive tuberculosis to one of three regimens : a control regimen that included 2 months of ethambutol , isoniazid , rifampicin , and pyrazinamide administered daily followed by 4 months of daily isoniazid and rifampicin ; a 4-month regimen in which the isoniazid in the control regimen was replaced by moxifloxacin administered daily for 2 months followed by moxifloxacin and 900 mg of rifapentine administered twice weekly for 2 months ; or a 6-month regimen in which isoniazid was replaced by daily moxifloxacin for 2 months followed by one weekly dose of both moxifloxacin and 1200 mg of rifapentine for 4 months .


Sputum specimens were examined on microscopy and after culture at regular intervals .


The primary end point was a composite treatment failure and relapse , with noninferiority based on a margin of 6 percentage points and 90 % confidence intervals .


We enrolled a total of 827 patients from South Africa , Zimbabwe , Botswana , and Zambia ; 28 % of patients were coinfected with the human immunodefiency virus .


In the per-protocol analysis , the proportion of patients with an unfavorable response was 4.9 % in the control group , 3.2 % in the 6-month group ( adjusted difference from control , -1.8 percentage points ; 90 % confidence interval [ CI ] , -6.1 to 2.4 ) , and 18.2 % in the 4-month group ( adjusted difference from control , 13.6 percentage points ; 90 % CI , 8.1 to 19.1 ) .


In the modified intention-to-treat analysis these proportions were 14.4 % in the control group , 13.7 % in the 6-month group ( adjusted difference from control , 0.4 percentage points ; 90 % CI , -4.7 to 5.6 ) , and 26.9 % in the 4-month group ( adjusted difference from control , 13.1 percentage points ; 90 % CI , 6.8 to 19.4 ) .


The 6-month regimen that included weekly administration of high-dose rifapentine and moxifloxacin was as effective as the control regimen .


The 4-month regimen was not noninferior to the control regimen .


( Funded by the European and Developing Countries Clinical Trials Partnership and the Wellcome Trust ; RIFAQUIN Current Controlled Trials number , ISRCTN44153044 . )


Treatment for displaced proximal humeral fractures is still under debate .


Few studies exist at the highest level of evidence .


Although reversed total shoulder prosthesis has gained popularity and showed promising results in the treatment for proximal humeral fractures in the elderly patients , no randomized controlled trials exist to the authors ' knowledge .


This study is a randomized semi-blinded controlled multicenter trial designed according to the Consort statement and the recommendations given by the Cochrane reviewers for proximal humeral fractures .


The study will investigate whether a reversed total shoulder prosthetic replacement gain better functional outcome compared to open reduction and internal fixation using an angular stable plate in displaced three - and four parts proximal humeral fractures after two and five years follow-up .


Participants are aged 65-85 admitted in seven different hospitals with a displaced proximal humeral fracture according to AO-OTA type 11-B2 or 11-C2 .


The intervention group is surgical treatment using a reversed total shoulder prosthesis ( Delta X-tend ) compared to open reduction and internal fixation with an angular stable plate ( Philos ) and thread cerclage in the control group .


60 patients will be randomized to each group.The primary outcome is shoulder function ( Constant score ) .


Secondary outcomes will be patient self-assessment form ( Oxford shoulder score ) , a quality of life questionnaire ( 15D score ) and resource implications ( cost-effectiveness ) .


Follow-ups take place at 3 , 6 , 12 and 24 months , and five years .


The trial design is semi-blinded with blinded physiotherapists performing the functional testing of patients at all follow-ups .


Randomization to treatment groups is electronic online , by independent supervisor ( web-CRF ) .


The recruitment of patients started at January 1 .


st 2013 .


Inclusion of 120 patients during three years is expected .


This semiblinded trial include a high number of patients compared to existing randomized trials in this field .


To our knowledge and according to ClinicalTrials.gov , this is the first study that compare these two treatments for a displaced proximal humeral fracture in elderly patients .


This may provide important information to help the surgeon to decide the best treatment in the future .


ClinicalTrials.gov Identifier : NCT01737060 .


Increasing ambient temperature to prevent intraoperative patient hypothermia remains widely advocated despite unconvincing evidence of efficacy .


Heat stress is associated with decreased cognitive and psychomotor performance across multiple tasks but remains unexamined in an operative context .


We assessed the impact of increased ambient temperature on laparoscopic operative performance and surgeon cognitive stress .


Forty-two performance measures were obtained from 21 surgery trainees participating in the counter-balanced , within-subjects study protocol .


Operative performance was evaluated with adaptations of the validated , peg-transfer , and intracorporeal knot-tying tasks from the Fundamentals of Laparoscopic Surgery program .


Participants trained to proficiency before enrollment .


Task performance was measured at two ambient temperatures , 19 and 26C ( 66 and 79F ) .


Participants were randomly counterbalanced to initial hot or cold exposure before crossing over to the alternate environment .


Cognitive stress was measured using the validated Surgical Task Load Index ( SURG-TLX ) .


No differences in performance of the peg-transfer and intracorporeal knot-tying tasks were seen across ambient conditions .


Assessed via use of the six bipolar scales of the SURG-TLX , we found differences in task workload between the hot and cold conditions in the areas of physical demands ( hot 10 [ 3-12 ] , cold 5 [ 2.5-9 ] , P = .013 ) and distractions ( hot 8 [ 3.5-15 .5 ] , cold 3 [ 1.5-5 .5 ] , P = .001 ) .


Participant perception of distraction remained greater in the hot condition on full scoring of the SURG-TLX .


Increasing ambient temperature to levels advocated for prevention of intraoperative hypothermia does not greatly decrease technical performance in short operative tasks .


Surgeons , however , do report increased perceptions of distraction and physical demand .


The impact of these findings on performance and outcomes during longer operative procedures remains unclear .


This exploratory trial was performed to determine whether Daikenchuto accelerates recovery of gastrointestinal function in patients undergoing open colectomy for colon cancer .


A total of 386 patients undergoing colectomy at 1 of the 51 clinical trial sites in Japan from January 2009 to June 2011 were registered for the study ( JFMC39-0902 ) .


Patients received either placebo or Daikenchuto ( 15.0 g/day , t.i.d ) between post-operative day 2 and post-operative day 8 .


Primary end-points included time to first bowel movement , frequency of bowel movement and stool form .


The incidence of intestinal obstruction was evaluated post-operatively .


The safety profile of Daikenchuto until post-operative day 8 was also evaluated .


The results for 336 patients ( Daikenchuto , n = 174 ; placebo , n = 162 ) were available for statistical analysis .


The time to first bowel movement did not differ significantly between the two groups .


All patients reported having diarrhea or soft stools immediately after surgery , and the time until stool normalization ( 50th percentile ) in the Daikenchuto and placebo groups was 6 days and 7 days , respectively .


The placebo group had a significantly greater number of hard stools at post-operative day 8 ( P = 0.016 ) , and bowel movement frequency continued to increase until post-operative day 8 as well .


In contrast , bowel movement frequency in the Daikenchuto group increased until post-operative day 6 , however decreased from post-operative day 7 and was significantly lower at post-operative day 8 compared with the placebo group ( P = 0.024 ) .


The moderate effects of Daikenchuto were observed 1 week after the operation .


Although Daikenchuto had an effect on gastrointestinal function after open surgery in patients with colon cancer , this study did not show its clinical benefits adequately .


Little information exists about the role of fear-avoidance beliefs and catastrophizing in subacromial pain syndrome .


The purpose of this study was to investigate the associations among pain , catastrophizing , fear , and disability and the contribution of fear-avoidance beliefs to disability at baseline and at 3-month follow-up .


A cross-sectional and longitudinal analysis was conducted .


Baseline demographic and clinical data , including fear-avoidance beliefs and catastrophizing , of 90 patients were assessed for this analysis .


Disability was measured with the Shoulder Pain and Disability Index at baseline and at 3-month follow-up .


First , bivariate and partial correlations were calculated among pain , fear-avoidance beliefs , catastrophizing , and disability , based on the fear-avoidance model .


Second , the contribution of fear-avoidance beliefs to disability at baseline and at 3-month follow-up was examined with hierarchical regression analyses .


Correlations between clinical variables and disability were largely in line with the fear-avoidance model .


Regression analyses identified a significant contribution of fear-avoidance beliefs to baseline disability but not to disability at 3 months .


Patients with subacromial pain syndrome were studied ; therefore , the results should be transferred with caution to other diagnoses .


A modified version of the Fear-Avoidance Beliefs Questionnaire was used , which was not validated for this patient group .


Fear-avoidance beliefs contribute significantly to baseline disability but not to disability change scores after 3-month follow-up .


Duration of complaints and baseline disability were the main factors influencing disability change scores .


Although the results help to improve understanding of the role of fear-avoidance beliefs , further studies are needed to fully understand the influence of psychological and clinical factors on the development of disability in patients with subacromial shoulder pain .


Several publications have suggested that induction chemotherapy followed by extrapleural pneumonectomy ( EPP ) for patients with malignant pleural mesothelioma ( MPM ) patients is associated with exceedingly high morbidity and mortality , and the role of EPP is controversially debated .


The present retrospective study analyzed the perioperative outcome in 251 consecutively treated patients at three high-volume mesothelioma centers .


251 MPM patients completed EPP after platinum-based induction chemotherapy at three institutions for thoracic surgery over more than 10 years .


The rates of 30-day and 90-day mortality and of major morbidities ( pulmonary embolism , postoperative bleeding , acute respiratory distress syndrome , empyema , bronchopleural fistula ( BPF ) , chylothorax , patch failure ) were recorded .


Perioperative outcome was correlated to risk factors such as smoking history ( pack years ) , age at operation , body mass index , spirometry results , C-reactive protein , American Society of Anesthesiologists classification , chemotherapy regimen used , blood loss during operation , duration of operation , and characteristics of the tumor ( laterality , histologic subtype , pT and pN stage ) to find factors predicting 30-day and 90-day mortality or major morbidity .


The overall 30-day mortality was 5 % .


Within 90 days after operation , 8 % of the patients died .


The rates of 30-day and 90-day mortality were significantly higher in patients with high preoperative C-reactive protein values ( p = 0.001 and p < 0.0005 ) .


The spirometry values forced expiratory volume in 1 second and forced vital capacity exhaled ( FVCex ) were both associated with 30-day and 90-day mortality ( p = 0.001 and p < 0.0005 ; and p = 0.002 and p < 0.0005 ) .


Major morbidity occurred in 30 % of the patients , significantly more often after right-sided EPP ( p = 0.01 ) and after longer operations ( p < 0.0005 ) .


Empyema ( p < 0.0005 ) and acute respiratory distress syndrome ( p = 0.02 ) were associated with longer duration of operation .


EPP after induction chemotherapy is a demanding procedure but can be performed with acceptable morbidity and mortality if patients are well selected and treated at dedicated high-volume MPM centers .


To investigate the efficacy of lubiprostone compared to Senna on bowel symptoms and constipation in post-operative orthopedic patients treated with opioids .


In this double blind , randomized , active comparator trial , adults who required opioids for analgesia following orthopedic procedures and who were admitted in inpatient rehabilitation were randomized following baseline assessments to lubiprostone ( Amitza ( ) ) , orally twice a day or Senna ( generic ) two capsules administered daily for six days .


Subjects were assessed using the patient assessment of constipation ( PAC ) - symptoms ( PAC-SYM ) and the PAC-quality of life ( PAC-QOL ) scales measured at baseline and Day 7 ; Subjects were assessed daily for secondary measures included the Bristol stool scale bowel consistency , specific bowel symptom score ( Nausea , cramping , straining , completeness , abdominal pain , time per lavatory attempt , assistance needed ) , adverse events and rescue medications required .


Function was measured using the functional independence measure ( FIM ) at admission and discharge ; length of stay ( LOS ) and missed treatments due to gastrointestinal symptoms were also assessed .


64 adults were enrolled ; 56 participants ( 28 in each group ) had baseline and follow up measures and were included in the intention to treat ( ITT ) analyses .


43 participants completed the study , 21 in the active lubiprostone and 22 in the active Senna group .


The mean age of the participants was 71.5 years ( SD = 11.4 years , range : 28-96 years ) .


In the ITT analyses , participants showed significant improvement in bowel symptoms as measured by the PAC-SYM ( mean SD , -0.28 0.60 , range : -1 -2.33 ) and PAC-QOL ( mean SD , 0.33 0.81 , range : -1.5 -2.0 ) over time , but there were no significant differences between the lubiprostone and Senna groups in mean change in the PAC-SYM ( -0.20 0.60 vs -0.36 0.61 , P = 0.61 respectively ) or the PAC-QOL ( 0.29 0.76 vs 0.37 0.87 , P = 0.61 respectively ) .


The mean change in each bowel symptom also did not significantly differ between treatment groups on ITT analyses , except for completeness of bowel movement , with the Senna group showing greater negative mean change in bowel movement completeness ( -0.56 1.01 vs -2.00 1.41 , P = 0.03 ) and for reduction of abdominal pain , favoring Senna ( -0.14 0.73 vs -0.73 1.08 , P = 0.04 ) .


Fifteen ( 75 % ) participants in the lubiprostone and in the Senna group requested rescue treatments .


Participants made significant functional improvement from admission to discharge over a median LOS of 12 d , with a mean FIM change of 29.13 13.58 and no significant between group differences ( 27.0 9.2 vs 31.5 16.6 , P = 0.27 ) .


Both lubiprostone and Senna improved constipation-related symptoms and QOL in opioid-induced constipation , with no significant between-group differences .


Unhealthy alcohol use is a leading contributor to the global burden of disease , particularly among young people .


Systematic reviews suggest efficacy of web-based alcohol screening and brief intervention and call for effectiveness trials in settings where it could be sustainably delivered .


To evaluate a national web-based alcohol screening and brief intervention program .


A multisite , double-blind , parallel-group , individually randomized trial was conducted at 7 New Zealand universities .


In April and May of 2010 , invitations containing hyperlinks to the Alcohol Use Disorders Identification Test-Consumption ( AUDIT-C ) screening test were e-mailed to 14,991 students aged 17 to 24 years .


Participants who screened positive ( AUDIT-C score 4 ) were randomized to undergo screening alone or to 10 minutes of assessment and feedback ( including comparisons with medical guidelines and peer norms ) on alcohol expenditure , peak blood alcohol concentration , alcohol dependence , and access to help and information .


A fully automated 5-month follow-up assessment was conducted that measured 6 primary outcomes : consumption per typical occasion , drinking frequency , volume of alcohol consumed , an academic problems score , and whether participants exceeded medical guidelines for acute harm ( binge drinking ) and chronic harm ( heavy drinking ) .


A Bonferroni-corrected significance threshold of .0083 was used to account for the 6 comparisons and a sensitivity analysis was used to assess possible attrition bias .


Of 5135 students screened , 3422 scored 4 or greater and were randomized , and 83 % were followed up .


There was a significant effect on 1 of the 6 prespecified outcomes .


Relative to control participants , those who received intervention consumed less alcohol per typical drinking occasion ( median 4 drinks [ interquartile range { IQR } , 2-8 ] vs 5 drinks [ IQR 2-8 ] ; rate ratio [ RR ] , 0.93 [ 99.17 % CI , 0.86-1 .00 ] ; P = .005 ) but not less often ( RR , 0.95 [ 99.17 % CI , 0.88-1 .03 ] ; P = .08 ) or less overall ( RR , 0.95 [ 99.17 % CI , 0.81-1 .10 ] ; P = .33 ) .


Academic problem scores were not lower ( RR , 0.91 [ 99.17 % CI , 0.76-1 .08 ] ; P = .14 ) and effects on the risks of binge drinking ( odds ratio [ OR ] , 0.84 [ 99.17 % CI , 0.67-1 .05 ] ; P = .04 ) and heavy drinking ( OR , 0.77 [ 99.17 % CI , 0.56-1 .05 ] ; P = .03 ) were not significantly significant .


In a sensitivity analysis accounting for attrition , the effect on alcohol per typical drinking occasion was no longer statistically significant .


A national web-based alcohol screening and brief intervention program produced no significant reductions in the frequency or overall volume of drinking or academic problems .


There remains a possibility of a small reduction in the amount of alcohol consumed per typical drinking occasion .


anzctr.org.au Identifier : ACTRN12610000279022 .


To evaluate efficacy and side effects of glycididazole sodium ( CMNa ) combined with chemotherapy ( cisplatin plus 5-FU/folic acid , PLF ) and radiotherapy in treating patients with locally advanced nasopharyngeal carcinoma .


Patients with III ~ IV stage nasopharyngeal carcinoma ( NPC ) , were randomly divided into treatment group ( 46 patients ) and control group ( 45 patients ) .


Both groups received radiotherapy concomitant with PLF chemotherapy .


The treatment group at the same time was given CMNa ( 800 mg/m2 before radiotherapy ) , by l h intravenous drip , three times a week .


When the dose of radiation was over 60 Gy , complete response rates of nasopharyngeal tumor and lymph node metastases in treatment group were significantly higher than in the control group ( 93.5 % vs 77.8 % ; 89.1 % vs 93.5 % , p < 0.05 ) .


Three months after radiotherapy , complete response rate of nasopharynx cancer and lymph node metastases in treatment group was both 97.8 % , again higher than in the control group ( 84.4 % and 82.2 % ) ( p < 0.05 ) .


In the treatment group , 1 , 3 , 5 year disease-free survival rates were 95.7 % , 86.7 % and 54.5 % ; and in control group , the corresponding disease-free survival rates were 93.3 % , 66.2 % and 38.6 % , respectively , the difference being statistically significant ( log-rank = 5.887 , p = 0.015 ) .


One , 3 , 5 year overall survival rates in two groups of patients were 97.8 % , 93.5 % , 70.4 % and 95.5 % , 88.07 % , 48.4 % , respectively , again with a statistically significant difference ( log-rank = 6.470 , p = 0.011 ) .


Acute toxicity and long-term radiotherapy related toxicity in the two groups did not differ ( p > 0.05 ) .


Glycididazole sodium could improve curative effects without increasing adverse reactions when treating patients with locally advanced nasopharyngeal carcinoma .


Guided self-help is a recommended first-step treatment for bulimia nervosa , binge eating disorder and atypical variants of these disorders .


Further research is needed to compare guided self-help that is delivered face-to-face versus via email .


This clinical trial uses a randomised , controlled design to investigate the effectiveness of providing guided self-help either face-to-face or via e-mail , also using a delayed treatment control condition .


At least 17 individuals are required per group , giving a minimum N of 51 .


Symptom outcomes will be assessed and estimates of cost-effectiveness made .


Results are proposed to be disseminated locally and internationally ( through submission to conferences and peer-reviewed journals ) , and will hopefully inform local service provision .


The trial has been approved by an ethics review board and was registered with ClinicalTrials.gov NCT01832792 on 9 April 2013 .


Although antiretroviral pre-exposure prophylaxis prevents HIV acquisition , it is not known if it alters HIV disease progression .


This study assesses whether tenofovir gel impacted on disease progression among CAPRISA 004 microbicide trial seroconvertors .


Eighty-three seroconvertors from the tenofovir and placebo gel arms of the CAPRISA 004 trial were monitored prospectively for a minimum of 2 years by CD4 count and viral load ( VL ) .


Linear mixed models were fitted to HIV VL , and log rank test was used to compare time to reach CD4 counts of < 350 cells per microliter .


Median 2-week postinfection VL was 4.74 and 4.45 log copies per milliliter in women assigned to tenofovir gel ( n = 32 ) and placebo gel ( n = 51 ) ( P = 0.189 ) .


Corresponding 12-month postinfection VLs were 4.24 and 3.70 log copies per milliliter ( P = 0.016 ) .


After adjusting for clinical and behavioral characteristics and protective HLA alleles , mean VLs within the first 2 years were 4.51 and 4.02 log copies per milliliter in women from the tenofovir and placebo arms ( P = 0.013 ) .


Among women with vaginal tenofovir measurements , mean VLs were 4.53 and 4.60 log copies per milliliter in those with detectable versus undetectable levels ( P = 0.840 ) .


Overall mean CD4 counts were 463 and 514 cells per microliter in women assigned to tenofovir and placebo ( P = 0.290 ) .


Thirty-two women ( 38.6 % ) reached CD4 counts of < 350 cells per microliter at median 9.4 months postinfection , 13 ( 40.6 % ) from the tenofovir and 19 ( 37.3 % ) from the placebo arms ( P = 0.786 ) .


Tenofovir gel had no impact on postinfection CD4 counts or the rate of CD4 decline .


Although seroconvertors from the tenofovir arm experienced higher VLs , this did not result in a need for earlier antiretroviral therapy .


To determine whether providing a controlled resistance versus assistance to the paretic leg at the ankle during treadmill training will improve walking function in individuals poststroke .


Repeated assessment of the same patients with parallel design and randomized controlled study between 2 groups .


Research units of rehabilitation hospitals .


Patients ( N = 30 ) with chronic stroke .


Subjects were stratified based on self-selected walking speed and were randomly assigned to the resistance or assistance training group .


For the resistance group , a controlled resistance load was applied to the paretic leg at the ankle to resist leg swing during treadmill walking .


For the assistance group , a load that assists swing was applied .


Primary outcome measures were walking speed and 6-minute walking distance .


Secondary measures included clinical assessments of balance , muscle tone , and quality of life .


Outcome measures were evaluated before and after 6 weeks of training and at 8 weeks ' follow-up , and compared within group and between the 2 groups .


After 6 weeks of robotic training , walking speed significantly increased for both groups , with no significant differences in walking speed gains observed between the 2 groups .


In addition , 6-minute walking distance and balance significantly improved for the assistance group but not for the resistance group .


Applying a controlled resistance or an assistance load to the paretic leg during treadmill training may induce improvements in walking speed in individuals poststroke .


Resistance training was not superior to assistance training in improving locomotor function in individuals poststroke .


Newer studies suggest that carvedilol , a beta-blocker with a moderate anti-alpha-1 activity , is superior to propranolol in reducing the portal pressure and risk of variceal bleeding .


The effect on arterial blood pressure is a matter of concern especially in decompensated patients .


to assess potential differential effects of beta-blockers and beta-blockers with moderate anti-alpha-1 activity on selected haemodynamic , humoral , and respiratory characteristics in cirrhosis .


Patients with cirrhosis and portal hypertension were randomised to receive carvedilol ( n = 16 ) or propranolol ( n = 13 ) .


Cardiac , systemic and splanchnic parameters along with oxygen saturation and plasma renin were measured at inclusion and after 3 months .


Arterial blood pressure , heart rate , and cardiac output decreased equally , central circulation time and systemic vascular resistance increased significantly but similarly .


Central blood volume , plasma volume and arterial compliance were unaltered .


The QTc interval and renin levels decreased in the carvedilol group , however not significantly different from the propranolol group .


Arterial oxygen saturation and alveolar arterial oxygen gradient remained constant in both groups .


Hepatic venous pressure gradient decreased equally in the carvedilol and propranolol groups ( -17 % and -20 % , non significant ) .


Systemic haemodynamics and pulmonary effects of carvedilol and propranolol are modest and this study could not demonstrate any significant difference between the two treatments .


To assess the efficacy of a simple , goal-directed sepsis treatment protocol for reducing mortality in patients with severe sepsis in Zambia .


Single-center nonblinded randomized controlled trial .


Emergency department , ICU , and medical wards of the national referral hospital in Lusaka , Zambia .


One hundred twelve patients enrolled within 24 hours of admission with severe sepsis , defined as systemic inflammatory response syndrome with suspected infection and organ dysfunction


: Simplified Severe Sepsis Protocol consisting of up to 4 L of IV fluids within 6 hours , guided by jugular venous pressure assessment , and dopamine and/or blood transfusion in selected patients .


Control group was managed as usual care .


Blood cultures were collected and early antibiotics administered for both arms .


Primary outcome was in-hospital all-cause mortality .


One hundred nine patients were included in the final analysis and 88 patients ( 80.7 % ) were HIV positive .


Pulmonary infections were the most common source of sepsis .


In-hospital mortality rate was 64.2 % in the intervention group and 60.7 % in the control group ( relative risk , 1.05 ; 95 % CI , 0.79-1 .41 ) .


Mycobacterium tuberculosis complex was isolated from 31 of 82 HIV-positive patients ( 37.8 % ) with available mycobacterial blood culture results .


Patients in Simplified Severe Sepsis Protocol received significantly more IV fluids in the first 6 hours ( 2.7 L vs 1.7 L , p = 0.002 ) .


The study was stopped early because of high mortality rate among patients with hypoxemic respiratory failure in the intervention arm ( 8/8 , 100 % ) compared with the control arm ( 7/10 , 70 % ; relative risk , 1.43 ; 95 % CI , 0.95-2 .14 ) .


Factors other than tissue hypoperfusion probably account for much of the end-organ dysfunction in African patients with severe sepsis .


Studies of fluid-based interventions should utilize inclusion criteria to accurately capture patients with hypovolemia and tissue hypoperfusion who are most likely to benefit from fluids .


Exclusion of patients with severe respiratory distress should be considered when ventilatory support is not readily available .


It is well known that receipt of an initial abnormal cervical cytology test can trigger considerable anxiety among women .


Less is known about the impact of follow-up by repeat cytology tests .


We quantified prevalence , and identified predictors , of distress after repeat cytologic testing in women with a single low-grade test .


Within the framework of the TOMBOLA randomized controlled trial of alternative managements , 844 women aged 20 to 59 years with a single routine cytology test showing borderline nuclear abnormalities ( BNA ; broadly equivalent to atypical squamous cells of undetermined significance ) were assigned to follow-up by repeat cytology in primary care ( the first test was due 6 months after the initial BNA result ) .


Women completed sociodemographic and psychosocial questionnaires at recruitment and the Impact of Event Scale ( IES ) 6 weeks after their first follow-up cytology test .


Factors associated with significant psychologic distress ( IES 9 ) were identified using logistic regression .


The response rate was 74 % ( n = 621/844 ) .


Of all the respondents , 39 % scored in the range for significant distress .


Distress varied by follow-up cytology result : negative , 36 % ; BNA or mild dyskaryosis , 42 % ; other ( including high grade and inadequate ) , 55 % .


After adjusting for the cytology result , risk of distress was significantly raised in women who had significant anxiety at recruitment , reported experiencing pain after the follow-up cytology , had children , or were dissatisfied with support they had received after their initial BNA test .


Substantial proportions of women experience surveillance-related psychologic distress after a follow-up cytology test , even when the result is negative .


This is an important , albeit unintended , consequence of cervical screening .


Strategies to alleviate this distress merit attention .


The World Health Organization recommends high-dose vitamin A supplementation ( VAS ) for children above six months of age in low-income countries .


VAS has been associated with up-regulation of the Th2 response .


We aimed to determine if VAS is associated with atopy in childhood .


Infants in Guinea-Bissau were randomly allocated VAS or placebo , either at six and nine months of age , or only at nine months of age .


At six months of age , children were furthermore randomized to measles vaccine or inactivated polio vaccine .


At nine months of age all children received measles vaccine .


Children were revisited seven years later and skin prick testing was performed .


Atopy was defined as a skin prick reaction 3 mm .


40 of 263 children ( 15 % ) were atopic .


Overall VAS had no significant effect on the risk of atopy ( Prevalence Ratio 1.23 ; 95 % CI 0.69-2 .18 ) .


The Prevalence Ratio was 1.60 ( 0.66-3 .90 ) for males and 1.00 ( 0.46-2 .15 ) for females .


There was no significant effect of VAS in infancy on atopy later in childhood .


The role of infant VAS in the development of atopy is still unclear .


Dupilumab , a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13 , has shown efficacy in patients with asthma and elevated eosinophil levels .


The blockade by dupilumab of these key drivers of type 2 helper T-cell ( Th2 ) - mediated inflammation could help in the treatment of related diseases , including atopic dermatitis .


We performed randomized , double-blind , placebo-controlled trials involving adults who had moderate-to-severe atopic dermatitis despite treatment with topical glucocorticoids and calcineurin inhibitors .


Dupilumab was evaluated as monotherapy in two 4-week trials and in one 12-week trial and in combination with topical glucocorticoids in another 4-week study .


End points included the Eczema Area and Severity Index ( EASI ) score , the investigator 's global assessment score , pruritus , safety assessments , serum biomarker levels , and disease transcriptome .


In the 4-week monotherapy studies , dupilumab resulted in rapid and dose-dependent improvements in clinical indexes , biomarker levels , and the transcriptome .


The results of the 12-week study of dupilumab monotherapy reproduced and extended the 4-week findings : 85 % of patients in the dupilumab group , as compared with 35 % of those in the placebo group , had a 50 % reduction in the EASI score ( EASI-50 , with higher scores in the EASI indicating greater severity of eczema ) ( P < 0.001 ) ; 40 % of patients in the dupilumab group , as compared with 7 % in the placebo group , had a score of 0 to 1 ( indicating clearing or near-clearing of skin lesions ) on the investigator 's global assessment ( P < 0.001 ) ; and pruritus scores decreased ( indicating a reduction in itch ) by 55.7 % in the dupilumab group versus 15.1 % in the placebo group ( P < 0.001 ) .


In the combination study , 100 % of the patients in the dupilumab group , as compared with 50 % of those who received topical glucocorticoids with placebo injection , met the criterion for EASI-50 ( P = 0.002 ) , despite the fact that patients who received dupilumab plus glucocorticoids used less than half the amount of topical glucocorticoids used by those who received placebo plus the topical medication ( P = 0.16 ) .


Adverse events , such as skin infection , occurred more frequently with placebo ; nasopharyngitis and headache were the most frequent adverse events with dupilumab .


Patients treated with dupilumab had marked and rapid improvement in all the evaluated measures of atopic dermatitis disease activity .


Side-effect profiles were not dose-limiting .


( Funded by Regeneron Pharmaceuticals and Sanofi ; ClinicalTrials.gov numbers , NCT01259323 , NCT01385657 , NCT01639040 , and NCT01548404 . )


To determine whether a 2-year family-based intervention using frequent contact and limited expert involvement was effective in reducing excessive weight compared with usual care .


Two hundred and six overweight and obese ( BMI 85th percentile ) children aged 4 to 8 years were randomized to usual care ( UC ) or tailored package ( TP ) sessions at university research rooms .


UC families received personalized feedback and generalized advice regarding healthy lifestyles at baseline and 6 months .


TP families attended a single multidisciplinary session to develop specific goals suitable for each family , then met with a mentor each month for 12 months , and every third month for another 12 months to discuss progress and provide support .


Outcome measurements ( anthropometry , questionnaires , dietary intake , accelerometry ) were obtained at 0 , 12 , and 24 months .


BMI at 24 months was significantly lower in TP compared with UC children ( difference , 95 % confidence interval : -0.34 , -0.65 to -0.02 ) , as was BMI z score ( -0.12 , -0.20 to -0.04 ) and waist circumference ( -1.5 , -2.5 to -0.5 cm ) .


TP children consumed more fruit and vegetables ( P = .038 ) and fewer noncore foods ( P = .020 ) than UC children , and fewer noncore foods were available in the home ( P = .002 ) .


TP children were also more physically active ( P = .035 ) .


No differences in parental feeding practices , parenting , quality of life , child sleep , or behavior were observed .


Frequent , low-dose support was effective for reducing excessive weight in predominantly mild to moderately overweight children over a 2-year period .


Such initiatives could feasibly be incorporated into primary care .


Inhaled allergen challenge is a standard method to study airway responses to inflammatory provocation and evaluate the therapeutic potential of novel anti-inflammatory compounds in asthma .


MEM 1414 is a novel oral PDE4 inhibitor with high affinity and selectivity creating the potential for an improved side effect profile vs non-selective PDE inhibitors .


We evaluated the tolerability and effect of MEM 1414 on airway responses in mild asthmatics .


A randomised double blind placebo controlled cross over study in two centres , in which sixteen steroid nave atopic asthmatics were challenged with inhaled allergen .


Subjects were dosed with MEM 1414 ( 600mg ) or placebo , twice daily orally for 7days .


Allergen challenge was performed on day 6 ( 2hours post-dose ) , and methacholine responsiveness was measured 24hours post allergen ( day 7 ) .


Biomarkers of drug effects using ex vivo LPS stimulation of whole blood production of interleukin ( IL ) -6 and leukotriene ( LT ) - B4 and fractional exhaled nitric oxide ( FeNO ) were measured on day 6 ( 0 , 2 and 8hours post-dose ) .


Plasma pharmacokinetics were measured on days 1 , 6 and 7 .


The primary endpoint was the effect on late asthmatic response to allergen .


Treatment with MEM 1414 abrogated the late phase response with a mean difference in FEV1 ( LAR 3-10 hours ) of 104ml ( 25 % ) vs placebo ( p < 0.005 ) , with no effect on the early response .


Biomarker responses were also attenuated with MEM 1414 treatment with reductions in LPS-stimulated whole blood assays for TNF at 8hours ( p < 0.03 ) and LTB4 at 24hours ( p = 0.0808 ) with no change in the IL-6 response .


The MEM 1414 treatment phase was associated with higher incidence of nausea ( 6/16 MEM 1414 vs 2/16 placebo ) and vomiting ( 3/16 vs 0/16 placebo ) .


Oral MEM 1414 , a novel PDE4 inhibitor , significantly reduces the late response following inhaled allergen challenge .


MEM 1414 also inhibited whole blood assays of cytokine production from inflammatory cells .


MEM 1414 was associated with a typical adverse event profile of PDE4 inhibitors , namely nausea and vomiting although these were mild side effects .


Current controlled trials ISRCTN48047493 .


Incidence and severity of motion sickness ( MS ) in hot-humid environment are extremely high .


We tried to know the effect of two-stage training for reducing incidence and severity of ms.


Sixty male subjects were divided into experimental group and control group randomly .


Subjects in experimental group received : ( 2 ) adaptation training including sitting , walking and running in hot lab .


After adaptation confirmation based on subjective feeling , rectal temperature , heart rate , blood Pressure , sweat rates and sweat salt concentration , we tested both groups by Coriolis acceleration revolving chair test and recorded Graybiel 's score and grading of severity to evaluate whether adaptation training was useful ; ( 2 ) Anti-dizzy training 3m later of deacclimatization contained revolving chair training for 10 times .


Then we did the same test as mentioned above to evaluate effect of anti-dizzy training .


RESULST : Graybiel ' s score and grading of severity had no difference between two groups through acclimatization training ( P > 0.05 ) .


While they had difference through anti-dizzy training ( P < 0.01 ) .


Adaptation training seems useless for reducing incidence and severity of MS in hot-humid environment , but anti-dizzy training is useful .


Local infiltration analgesia ( LIA ) is well established for effective postoperative pain relief in total knee arthroplasty ( TKA ) .


To prolong the effect of LIA , infusion pumps with local intraarticular analgesia can be used .


We evaluated the effect of such an infusion pump for the first 48 h postoperatively regarding pain , knee function , length of stay ( LOS ) in hospital , and complications .


200 patients received peroperative LIA and a continuous intraarticular elastomeric infusion pump set at 2 mL/h .


The patients were randomized either to ropivacaine ( 7.5 mg/mL ) or to NaCl ( 9 mg/mL ) in the pump .


Visual analog scale ( VAS ) pain ( 0-100 mm ) , analgesic consumption , side effects of medicine , range of motion ( ROM ) , leg-raising ability , LOS , and complications during the first 3 months were recorded .


On the first postoperative day , the ropivacaine group had lower VAS pain ( 33 vs. 40 at 12 noon and 36 vs. 43 at 8 p.m. ; p = 0.02 and 0.03 , respectively ) , but after that all recorded variables were similar between the groups .


During the first 3 months , the ropivacaine group had a greater number of superficial and deep surgical wound infections ( 11 patients vs. 2 patients , p = 0.02 ) .


There were no other statistically significant differences between the groups .


Continuous intraarticular analgesia ( CIAA ) with ropivacaine after TKA has no relevant clinical effect on VAS pain and does not affect LOS , analgesic consumption , ROM , or leg-raising ability .


There may , however , be a higher risk of wound-healing complications including deep infections .


Metabolic syndrome ( MetS ) is associated with adverse cardiovascular events , and impaired vascular function .


In this study we evaluated the effects of omega-3 polyunsaturated fatty acids ( PUFAs ) supplementation on vascular function , inflammatory and fibrinolytic process in subjects with MetS .


We studied the effect of a 12 weeks oral treatment with 2 g/day of omega-3 PUFAs in 29 ( 15 male ) subjects ( mean age 44 12 years ) with MetS on three occasions ( day0 : baseline , day 28 and day 84 ) .


The study was carried out on two separate arms ( PUFAs and placebo ) , according to a randomized , placebo-controlled , double-blind , cross-over design .


The diagnosis of MetS was based on the guidelines of Adult Treatment Panel III definition .


Endothelial function was evaluated by flow-mediated dilation ( FMD ) of the brachial artery .


Carotid-femoral pulse wave velocity ( PWV ) was measured as an index of aortic stiffness .


Serum levels of interleukin-6 ( IL-6 ) and plasminogen activator inhibitor-1 ( PAI-1 ) were measured by ELISA .


Treatment with PUFAs resulted in a significant improvement from day 0 to 28 and 84 in FMD and PWV ( p < 0.001 for all ) .


Nevertheless , treatment with placebo resulted in no significant changes in FMD ( p = 0.63 ) and PWV ( p = 0.17 ) .


Moreover , PUFAs treatment , compared to placebo , decreased IL-6 levels ( p = 0.03 ) and increased PAI-1 levels ( p = 0.03 ) .


Finally , treatment with PUFAs resulted in a significant decrease in fasting triglyceride levels from day 0 to 28 and 84 ( p < 0.001 ) and in serum total cholesterol levels ( p < 0.001 ) .


In subjects with MetS , treatment with omega-3 PUFAs improved endothelial function and arterial stiffness with a parallel antiinflammatory effect .


The optimal management of treatment for patients at intermediate risk of a common duct stone ( including increased liver function tests but bilirubin < 4 mg/dL and no cholangitis ) is a matter of debate .


Many stones migrate spontaneously into the duodenum , making preoperative common duct investigations unnecessary .


To compare strategies of cholecystectomy first vs a sequential endoscopic common duct assessment and cholecystectomy for the management of patients with an intermediate risk of a common duct stone .


The main objective was to reduce the length of stay and the secondary objectives were to reduce the number of common duct investigations , morbidity , and costs .


Interventional , randomized clinical trial with 2 parallel groups performed between June 2011 and February 2013 , with a patient follow-up of 6 months .


The trial comprised a random sample of 100 adult patients admitted to Geneva University Hospital , Geneva , Switzerland , for acute gallstone-related conditions with an intermediate risk of a common duct stone .


Fifty patients were randomized to each group .


Cholecystectomy first with intraoperative cholangiogram for the study group and endoscopic common duct assessment and clearance followed by cholecystectomy for the control group .


Length of initial hospital stay ( primary end point ) , number of common duct investigations and morbidity and mortality within 6 months after initial admission , and quality of life at 1 and 6 months after discharge ( EQ-5D-5L [ EuroQol Group , 5-level ] questionnaire ) .


Patients who underwent cholecystectomy as a first step had a significantly shorter length of hospital stay ( median , 5 days [ interquartile range { IQR } , 1-8 ] vs median , 8 days [ IQR , 6-12 ] ; P < .001 ) , with fewer common duct investigations ( 25 vs 71 ; P < .001 ) , no significant difference in morbidity or quality of life .


Among patients at intermediate risk of a common duct stone , initial cholecystectomy compared with sequential common duct endoscopy assessment and subsequent surgery resulted in a shorter length of stay without increased morbidity .


If these findings are confirmed , initial cholecystectomy with intraoperative cholangiogram may be a preferred approach .


Clinicaltrials.gov Identifier : NCT01492790 .


To compare the safety of a single-piece , foldable intraocular lens ( IOL ) hydroimplantation with that of a standard implantation using an ophthalmic viscosurgical device ( OVD ) .


One hundred consecutive patients with bilateral age-related cataract surgery were enrolled into a prospective double-blind study .


Each patient 's first eye was randomly assigned to a standard implantation technique with an OVD or the hydroimplantation technique , while the fellow eye received the opposite technique .


The main outcomes measured were endothelial cell loss , postoperative changes of intraocular pressure ( IOP ) , and the frequency of complications .


The reduction of endothelial cell density 1 month and 6 months after the surgery was 9.76 % 13.5 % , 10.7 % 12.6 % , respectively , in group A ( OVD ) and 9.07 % 12.7 % , 9.13 % 13.7 % , respectively , in group B ( hydroimplantation ) .


The differences were not statistically significant .


The mean IOP 2 hours after surgery was 10.19 6.78 mm Hg in group A and 9.92 7.01 mm Hg in group B. Twenty-four hours and 1 month after surgery , the mean IOP was 14.52 5.59 mm Hg and 13.21 3.5 mm Hg , respectively , in group A , and 15.45 5.77 mm Hg and 13.1 3.44 mm Hg , respectively , in group B.


The differences between groups A and B were not statistically significant .


The hydroimplantation technique is a safe technique for single-piece foldable IOL implantation .


There was no increase in intraoperative and postoperative complications compared with the standard implantation technique using an OVD .


This study aimed to investigate how the organic cation transporter 2 nucleotide polymorphism at site 808 ( G T ) affects metformin pharmacokinetics and its long-term anti-diabetic effect .


A total of 220 newly diagnosed type 2 diabetes patients taking oral metformin were recruited , genotyped and then divided into three groups by SLC22A2 genotypes ( G/G , G/T , T/T ) .


Nine patients in the GG genotype group , five patients in the GT genotype group and four patients in the TT genotype group were randomly selected for the metformin pharmacokinetic study .


A randomized cohort study with 1-year follow-up was performed to clarify the metformin pharmacodynamics .


After 1 year , the decrease in glycosylated hemoglobin ( HbA1c ) levels in subjects with the heterozygous variant genotype ( GT ) was significantly greater than in those with the wild-type homozygote ( -2.2 % in GT vs. -1.1 % in GG , P < 0.05 ) after adjustment for baseline HbA1c levels , exercise and diet in each group .


There were also differences in the pharmacokinetic parameters ( 95 % confidence interval ) of metformin between these two groups [ area under the concentration-time curve ( AUC ) 0 - 19.7 ( 15.7-23 .8 ) vs. 14.3 ( 11.7-16 .9 ) g h/L ; renal clearance ( CLr ) 16.8 ( 8.5-25 .0 ) vs. 34.1 ( 24.9-43 .2 ) L/h ; tubular secretion clearance ( CLt ) 8.1 ( 2.2-18 .1 ) vs. 22.7 ( 15.5-29 .8 ) L/h ; all P < 0.05 ] .


Multivariate analysis further revealed that the presence of T alleles and gender were independent influencing factors of urine excretion of metformin ( P < 0.05 ) .


As well as gender , the glucose-lowering efficiency of metformin can be enhanced by SLC22A2 808G > T variants through the delay of its transportation and CLr in Chinese type 2 diabetes populations .


Electronic cigarettes ( e-cigarettes ) have been reported to reduce tobacco craving and withdrawal ; however , the mechanisms underlying these effects have not been elucidated .


This study examined the contributions of nicotine stimulus and response expectancies to responses to nicotine-free e-cigarettes in 21 e-cigarette nave smokers ( 12 male ) .


Participants completed two randomized experimental sessions in which they administered a nicotine-free e-cigarette .


During one session they were informed that the e-cigarette contained nicotine and during the other session they were informed that the e-cigarette was nicotine-free .


Participants completed subjective assessments before and immediately after sampling ten puffs from the e-cigarette and were then invited to earn additional puffs using a computerized progressive ratio task .


Prior to their enrolment in the study , participants provided an estimate of the relative importance of the nicotine content of e-cigarettes for craving relief .


Instructions that the e-cigarette contained nicotine were found to reduce both intention to smoke ( p = 0.017 ) and withdrawal-related ( p = 0.018 ) craving , regardless of a-priori reported beliefs regarding the relative importance of nicotine .


Nicotine content instructions were also found to be associated with a shorter latency to self-administration ( p = 0.005 ) ; however , a SexInstructionsResponse Expectancy interaction ( p = 0.008 ) revealed that this effect was specific to women who had strong a-priori nicotine content craving relief expectations .


Neither nicotine content instructions nor response expectancies impacted the number of puffs self-administered .


Findings suggest that nicotine content expectations contribute to smokers ' responses to e-cigarettes , and that a-priori beliefs about nicotine effects may be especially important in women .


Gastric intestinal metaplasia ( GIM ) is associated with a risk for development of intestinal-type gastric cancer .


This study aimed to compare the diagnostic yield of GIM from confocal laser endomicroscopy ( CLE ) and white light endoscopy ( WLE ) .


In a prospective , double-blind , randomized study , patients were randomly assigned to receive either CLE with targeted biopsies ( group A ) or WLE with a standard biopsy protocol ( group B ) .


A total of 168 patients were finally analyzed ( group A 85 , group B 83 ) .


On a per-patient analysis , the diagnostic yields of GIM ( including GIM with gastric intraepithelial neoplasia [ GIN ] ) for groups A and B were 44.71 % and 31.33 % , respectively ( P = 0.074 ) .


On a per-biopsy analysis , CLE-targeted biopsy gave a significantly higher diagnostic yield of GIM compared with WLE and standard biopsy , at 65.70 % ( 113/172 biopsies ) versus 15.73 % ( 81/515 biopsies ) ( P < 0.001 ) .


Moreover , the diagnostic yield of the operative link on gastric intestinal metaplasia ( OLGIM ) assessment stages III and IV was higher at 20.93 % ( 36/172 biopsies ) in group A versus 4.08 % ( 21/515 biopsies ) in group B ( P < 0.001 ) .


In addition , use of CLE-guided biopsy significantly decreased by 68 % ( P < 0.001 ) the mean number of biopsies required per patient .


CLE with targeted biopsies is superior to WLE with standard biopsies for the detection and surveillance of GIM .


The number of biopsies needed to confirm GIM is about one third of that needed with WLE with standard biopsies .


To assess whether outpatient cervical ripening at 41 0/7 weeks of gestation with the nitric oxide donor isosorbide mononitrate reduces cesarean delivery rates in nulliparous women with an unfavorable cervix .


We recruited nulliparous pregnant women with a Bishop score less than 6 in a randomized , multicenter , double-blind , placebo-controlled trial .


Women received 40 mg vaginal isosorbide mononitrate or a placebo at 41 0/7 , 41 2/7 , and 41 4/7 weeks of gestation .


They returned home between visits .


At 41 5/7 weeks of gestation , for women who had not yet given birth , labor was induced with oxytocin or prostaglandins , depending on cervical status .


We needed 685 women per group to detect a 25 % reduction in the cesarean delivery rate , the primary outcome measure , from 25 % in the placebo group to 18.75 % in the isosorbide mononitrate group ( 1 - = 0.8 , = 0.05 , two-sided ) .


The NOCETER ( NO donors for reduction of CEsareans at TERm ) trial was a negative study .


The cesarean delivery rate was 27.3 % ( 185/678 ) in the isosorbide mononitrate group and 27.2 % ( 186/684 ) in the placebo group ( relative risk 1.00 , 95 % confidence interval [ CI ] 0.84-1 .19 ) .


None of the maternal secondary efficacy outcomes differed between groups .


Side effects were more common among women receiving isosorbide mononitrate than in the placebo group ( 78.8 % [ 534/678 ] compared with 27.9 % [ 191/684 ] , relative risk 2.82 , 95 % CI 2.49-3 .20 ) .


Composite perinatal morbidity did not differ between groups .


Outpatient cervical ripening with vaginal isosorbide mononitrate for prolonged pregnancy in nulliparous women does not reduce cesarean delivery rate .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00930618 .


Activated Protein C ( APC ) stimulates multiple cytoprotective pathways via the protease activated receptor-1 ( PAR-1 ) and promotes anticoagulation .


3K3A-APC was designed for preserved activity at PAR-1 with reduced anticoagulation .


This Phase 1 trial characterized pharmacokinetics and anticoagulation effects of 3K3A-APC .


Subjects ( n = 64 ) were randomly assigned to receive 3K3A-APC ( n = 4 ) at 6 , 30 , 90 , 180 , 360 , 540 or 720 g/kg or placebo ( n = 6 ) and were observed for 24 hr .


After safety review additional subjects received drug every 12 hr for 5 doses ( n = 6 per group ) at 90 , 180 , 360 , or 540 g/kg or placebo ( n = 8 ) and were observed for 24 hr .


All subjects returned for safety assessments at 72 hours and 15 days .


We found few adverse events in all groups .


Systolic blood pressure increased in both active and placebo groups .


Moderately severe headache , nausea and vomiting were reported in one of two subjects treated with 720 g/kg so 540 g/kg was considered the highest tolerated dose .


Mean plasma concentrations increased in proportion to dose .


Clearance ranged from 11,693 807 to 18,701 4,797 mL/hr , volume of distribution ranged from 4,873828 to 6,971 1,169 mL , and elimination half-life ranged from 0.211 0.097 to 0.294 0.054 hours .


Elevations in aPTT were minimal .


3K3A-APC was well tolerated at multiple doses as high as 540 g/kg .


These results should be confirmed in stroke patients with relevant co-morbidities .


Clinical Trial Registration-URL : http://www.clinicaltrials.gov .


Unique identifier : NCT01660230 .


To evaluate the effect of warm ophthalmic viscosurgical devices ( OVDs ) on the unfolding time of prehydrated hydrophobic acrylic intraocular lenses ( IOLs ) .


Experimental study and human trial .


Three foldable hydrophobic acrylic IOLs ( enVista MX60 , AcrySof SN60AT , and Tecnis 1 ZCB00 ) .


The unfolding times of 3 kinds of IOLs were measured according to temperature from 26C to 32C in a transparent container filled with a mixture of OVDs and balanced salt solution .


The unfolding time of each IOL was measured 4 times for each temperature .


Unfolding time was defined as the time required for the folded IOL to recover 90 % of its overall optic diameter before folding .


In human trials , the unfolding time of the MX60 in a capsular bag filled with 30C OVDs was compared with that filled with room temperature OVDs for 4 cases in each group .


The unfolding time of the MX60 ( 215 25 seconds ) was significantly longer than that of the SN60AT ( 28 7 seconds ) and the ZCB00 ( 29 7 seconds ) at 26C ( p = 0.013 ) .


However , there were no differences in the unfolding time of 3 IOLs at 32C .


In human trials , the unfolding time of the MX60 was shorter in a capsular bag filled with 30C OVDs ( 32 13 seconds ) than if filled with OVDs kept at room temperature ( 127 27 seconds ; p = 0.029 ) .


When fast and complete unfolding characteristics are needed , filling the anterior chamber and capsular bag with OVDs warmed to 30C before IOL implantation is recommended .


Panic disorder with or without agoraphobia is a commonly occurring disorder affecting 2 to 3 % of the population in Sweden .


Untreated , panic disorder is a chronic condition that significantly increases the risk for psychiatric comorbidity , morbidity and mortality , employment difficulties , and healthcare utilization .


Cognitive behavioral approaches are the recommended first-line treatment for panic disorder ; however , many patients in routine care receive another evidence-based psychotherapy , including psychodynamic therapy .


Allowing patients to choose among evidence-based approaches to panic disorder may improve outcomes and reduce overall health costs .


Trials comparing the ` gold standard ' treatment for panic disorder to other evidence-based psychotherapies are needed , and also trials that can separate patient preferences for treatment from randomization effects on outcome , disability and healthcare utilization in the longer term .


A phase 2/3 doubly-randomized controlled trial carried out in routine care with 216 adults ( aged 18 to 70 years ) with a primary diagnosis of DSM-IV Panic Disorder ( with or without Agoraphobia ) .


Within each clinic , patients are randomized to self-selection , random assignment of treatment , or wait-list .


Patients choose or are randomly assigned to either Panic Control Treatment or Panic-Focused Psychodynamic Psychotherapy .


Primary outcomes are changes in panic symptom severity , occupational status , and sickness-related absences from work at post-treatment and 6 , 12 and 24 months post-treatment .


Secondary outcomes include changes in agoraphobic avoidance , psychiatric comorbidity , disability , and healthcare utilization .


The study also employs elements of an effectiveness trial as therapist and service-related effects on outcome will be estimated .


Putative change mechanisms for the two treatments are also assessed .


Cognitive behavioral and psychodynamic therapies are both evidence-based approaches that are routinely offered to panic disordered patients in Sweden .


However , little is known about the relative effectiveness of these two approaches for panic/agoraphobia , work-related disability and healthcare utilization over the longer term .


The current trial ( POSE ) also addresses the important but understudied issue of whether patient preference for a particular psychotherapeutic approach moderates outcome .


ClinicalTrials.gov NCT01606592 ( registered 19 March 2012 ) .


The sympathetic nervous system plays an important role in the arousal response .


Recently , the stellate ganglion block ( SGB ) was found to effectively treat anxiety and night awakening in humans and decrease electroencephalogram ( EEG ) indices of arousal responses in rat .


But , the role of the sympathetic block in human arousal responses has not yet been studied .


We performed this prospective , double-blinded , controlled volunteer study to investigate the sedative effects and bispectral index ( BIS ) changes of SGB .


A randomized , double-blind trial .


Single academic medical center .


This study was approved by the Ethics Committee of Kyungpook National University Hospital ( ref : KNUH-10-1081 ) and registered with CRiS ( Clinical Research Information Service , http://cris.cdc.go.kr , ref : KCT0000036 , 2010.9.24 ) .


Twenty healthy volunteers were enrolled in this study .


The volunteers were randomly assigned to one of 2 groups : the SGB group ( n = 10 ) and the sham group ( n = 10 ) .


Volunteers in SGB group received SGB and volunteers in the sham group received a sham procedure .


BIS value , heart rate , and blood pressure were measured before and 5 , 10 , 20 , and 30 minutes after the procedure .


Observer 's Assessment of Alertness/Sedation ( OAA/S ) scores were assessed before and 10 and 30 minutes after the intervention .


In the SGB group , BIS values and OAA/S scores significantly decreased after the intervention as compared to baseline ( P < 0.05 ) .


The values were also significantly decreased in the SGB group when compared to the values in sham group after the intervention ( P < 0.05 ) .


There was a significant change of mean blood pressure 10 to 30 minutes after SGB ( P < 0.05 ) .


There were no differences in heart rate during study period between groups .


This study is limited by a relatively small sample size .


This study showed that SGB has a sedative effect in normal healthy volunteers , as evidenced by decreased OAA/S scores and BIS values .


Despite the reported widespread use of herbal medicines globally and their benefits , they are not completely without potential to cause harm .


The haphazard , irresponsible or non-regulated use of several herbal medicines may put the health of their users at risk of toxicity .


This study aimed to assess the general perception of the safety and occurrence of adverse effects of herbal medicines among residents of Ikorodu in Lagos , Nigeria .


The study population included 400 randomly selected and consented residents in Ikorodu .


Data was collected using a standard closed and open-ended structured questionnaire with three ( 3 ) sections on socio-demography , safety and adverse effects of herbal medicines .


Associations between the variables were determined using Chi square analysis .


The results showed that 333 respondents ( 82.4 % ) believed that herbal medicines are safe for use and only 39 ( 9.7 % ) held the view that they may not be safe .


RESULTS also show that 51 ( 12.6 % ) of respondents had experienced adverse effects while 250 ( 61.9 % ) said they had never experienced adverse effects from the use of herbal medicines .


Herbal medicine is popular among the respondents but they appear to be ignorant of its potential toxicities .


It may be necessary to educate the consumers of herbal medicines on the potentials for herbs-drugs interaction and adverse effects specially as a result of indiscriminate and unguided use of herbal medicines .


To identify risk factors for early hospital readmission in low-income community-dwelling older adults .


Prospective cohort study .


University-affiliated urban safety-net healthcare system in Indianapolis , Indiana .


Community-dwelling adults aged 65 and older with annual income less than 200 % of the federal poverty level and enrolled in the Geriatric Resources for Assessment and Care of Elders ( GRACE ) randomized controlled trial ( N = 951 ) .


Participant health and functional status at baseline and 6 , 12 , 18 , and 24 months .


Early readmission was defined as a repeat hospitalization occurring within 30 days of a prior hospital discharge .


Candidate risk factors included sociodemographic characteristics , health and functional status , prior care , lifestyle , and satisfaction with care .


Of 457 index admissions in 328 participants , 85 ( 19 % ) were followed by an early readmission .


The independent risk factors for early readmission identified according to regression analysis were living alone ( odds ratio ( OR ) = 1.71 , 95 % confidence interval ( CI ) = 1.02-2 .87 ) , fair or poor satisfaction with primary care physician ( OR = 2.12 , 95 % CI = 1.01-4 .46 ) , not having Medicaid ( OR = 1.80 , 95 % CI = 1.05-3 .11 ) , receiving a new assistive device in the past 6 months ( OR = 2.26 , 95 % CI = 1.26-4 .05 ) , and staying in a nursing home in the past 6 months ( OR = 5.08 , 95 % CI = 1.56-16 .53 ) .


Age , race , sex , education , and chronic diseases were not associated with early readmission .


A broad range of nonmedical risk factors played a greater role than previously recognized in early hospital readmission of low-income seniors .


Gonadotropin therapy using a human chorionic gonadotropin ( hCG ) and FSH preparation is an effective regimen in inducing masculinization and spermatogenesis in men with idiopathic hypogonadotropic hypogonadism ( IHH ) .


However , the high cost of medication and frequent injections affect compliance .


The aim of this study was to determine the efficacy of sequential use of highly purified urinary FSH ( uFSH ) / hCG in men with IHH .


A randomized , open-label , prospective , controlled noninferiority trial with an 18-month follow-up was conducted in 9 tertiary hospitals .


A total of 67 Chinese men with IHH were randomly allocated into group A receiving continual uFSH ( 75 U , 3 times a week ) and hCG ( 2000 U , twice a week ) injection and group B receiving sequential uFSH ( 75 U , 3 times a week every other 3 months ) and hCG ( 2000 U , twice a week ) injection .


The primary outcome was the proportion of subjects with a sperm concentration of 1.0 10 ( 6 ) / mL during the 18 months .


The efficacy between groups A and B was compared for noninferiority .


Of the patients , 17/33 ( 51.5 % ) receiving continual uFSH/hCG and 19/34 ( 55.9 % ) receiving sequential uFSH/hCG achieved sperm concentrations of 1.0 10 ( 6 ) / mL .


The efficacy in the sequential uFSH/hCG group was not inferior to that in the continual uFSH/hCG group ( noninferiority , P = .008 ) by intention-to-treat analysis .


The efficacy of the sequential uFSH/hCG regimen is not inferior to that of the continual uFSH/hCG regimen in inducing spermatogenesis and masculinization of patients with IHH .


There was no standard treatment for hepatocellular carcinoma with portal vein tumour thrombosis ( PVTT ) .


This prospective , randomised , two-arm clinical trial aims to investigate the feasibility , safety and effectiveness of transarterial chemoembolisation ( TACE ) combined with the endovascular implantation of an iodine-125 seed strand for the treatment of hepatocellular carcinoma with portal vein tumour thrombosis versus conventional TACE .


Eighty-five patients who met the eligibility requirements were randomly assigned to receive the treatment of TACE combined with the endovascular implantation of an iodine-125 seed strand ( 43 cases ) or conventional TACE ( 42 cases ) .


The end points were survival time , complications related to the procedure and adverse events .


No significant differences in baseline characteristics were observed between groups .


The mean and median survival times were 221.7 16.3 days [ 95 % confidence interval ( CI ) 189.8-253 .6 days ] and 210.0 17.5 days ( 95 % CI 175.8-244 .2 days ) in group A and 155.1 7.9 days ( 95 % CI 139.6-170 .5 days ) and 154.0 11.2 days ( 95 % CI 133.2-176 .0 days ) in group B ( P = 0.000 ) .


The 90 - , 180 - and 360-day cumulative survival rates were 97.6 , 58.9 and 12.3 % in group A and 92.5 , 30.7 and 0 % in group B ( P = 0.000 ) .


Transarterial chemoembolisation combined with the endovascular implantation of an iodine-125 seed strand is feasible , safe and effective in the treatment for hepatocellular carcinoma with PVTT .


To compare the effectiveness of two different techniques to lift the maxillary sinus via a crestal approach : the Summers versus the Cosci technique .


Fifteen partially edentulous patients missing bilaterally maxillary molars and / or premolars , having 4 to 7 mm of residual crestal height and at least 5 mm thickness below the maxillary sinuses measured on CT scans , were randomised to have implants placed in sinuses crestally lifted according to the Cosci or the Summers techniques , with bone substitutes according to a split-mouth design .


Implants were left to heal submerged for 6 months .


Implants were loaded with acrylic provisional crowns/prostheses .


Screw-retained definitive metal-ceramic prostheses were delivered 4 months after provisional loading .


Outcome measures were : prosthesis and implant failures ; any complications ; operation time ; operator preference ; patient preference and peri-implant marginal bone level changes assessed by a blinded outcome assessor .


All patients were followed to 3 years after implant loading .


Nineteen study implants were placed according to each technique .


Three years after loading , 3 patients dropped out and no implant failed .


No discomfort/complications occurred at sites treated with the Cosci technique , whereas 12 patients reported discomfort during the augmentation procedure at the side treated with the Summers technique ; this was statistically significant ( P = 0.0005 ) .


In one of these patients , a perforation of the sinus membrane occurred .


Postoperatively , headache was reported by 9 patients and swelling occurred in 3 of these patients at the Summers treated sides .


Statistically significant less time ( 9.7 mins , SD = 4.0 , P < 0.001 , 95 % CI -11.9 to -7.5 ) was required to place implants according to the Cosci technique ( 33 versus 24 mins on average ) .


The 2 operators and 14 out of 15 patients preferred the Cosci technique 1 month after surgery ( P = 0.001 ) , and 1 year after surgery ( 13 out of 15 patients , P = 0.007 ) .


The ceramic layer of one prosthesis of the Summers ' group and one abutment screw of the Cosci 's group loosened between 1 to 3 years post-loading .


After 3 years , implants inserted according to the Cosci technique lost 1.39 mm of peri-implant bone versus 1.54 mm for the implants placed with the Summers technique .


There were no statistically significant differences for marginal bone level changes between the two groups ( difference 0.15 mm , 95 % CI -0.11 to 0.41 , P = 0.24 ) .


Both crestal sinus lift techniques produced successful results over a 3-year follow-up period , but the Cosci technique required less surgical time , determined less intra - and postoperative morbidity and was preferred by patients .


Conflict of interest statement : This was an investigator-initiated trial , however the trial was partially supported by Zimmer Dental Italy , Vittorio Veneto ( TV ) , Italy .


One of the authors ( Dr Cosci ) , who treated 8 patients in this study , is the inventor of the Cosci technique and his partipation was a prerequisite of the sponsor to support the trial .


To study the effect of blood activating water relieving method ( BAWRM ) on heart functions and serum levels of NT-proBNP in patients with heart failure with normal ejection fraction ( HFNEF ) .


Sixty-four HFNEF patients were admitted to our hospital during January 2011 to June 2012 .


They were randomly assigned to the treatment group ( 32 cases ) and the control group ( 32 cases ) .


Patients in the control group received routine Western medical treatment , while those in the treatment group additionally took Chinese medical recipes for activating blood circulation and relieving water retention .


Changes of Chinese medical syndromes , E/E ' , serum NT-proBNP contents were observed between the two groups .


Compared with before treatment , their Chinese medical syndromes and E/E ' were significantly improved , and serum NT-proBNP contents decreased in the two groups ( P < 0.05 ) .


Compared with the control group , Chinese medical syndromes , E/E ' , serum NT-proBNP contents obviously decreased in the treatment group , showing statistical difference ( P < 0.05 ) .


BAWRM was an effective way to improve the diastolic function of HFNEF patients and lower the serum level of NT-proBNP with confirmative efficacy .


This study aimed to implement a point-of-care cluster randomized trial using electronic health records .


We evaluated the effectiveness of electronically delivered decision support tools at reducing antibiotic prescribing for respiratory tract infections in primary care .


Family practices from England and Scotland participating in the Clinical Practice Research Datalink ( CPRD ) were included in the trial ; 53 family practices were allocated to intervention and 51 practices were allocated to usual care .


Patients aged 18 to 59 years consulting for respiratory tract infections were eligible .


The intervention was through remotely installed , computer-delivered decision support tools accessed during the consultations .


Control practices provided usual care .


The primary outcome was the proportion of consultations for respiratory tract infections with an antibiotic prescribed based on electronic health records .


Family practice-specific proportions were included in a cluster-level analysis .


Data were analyzed for 603,409 patients : 317,717 at intervention practices and 285,692 at control practices .


Use of the intervention was less than anticipated , varying among practices .


There was a reduction in proportion of consultations with antibiotics prescribed of 1.85 % ( 95 % CI , 0.10 % -3.59 % , P = .038 ) and in the rate of antibiotic prescribing for respiratory tract infections ( 9.69 % ; 95 % CI , 0.75 % -18.63 % , fewer prescriptions per 1,000 patient-years , P = .034 ) .


There were no adverse events .


Cluster randomized trials may be implemented efficiently in large samples from routine care settings by using primary care electronic health records .


Future studies should develop and test multicomponent methods for remotely delivered intervention .


to compare the biological efficacy of generic enoxaparin ( HeptronTM ) versus branded Sanofi-Aventis enoxaparin for prophylaxis and treatment of lower-extremity deep venous thrombosis ( DVT ) in a prospective , randomized , open-label study .


patients with diagnosed lower-extremity DVT ( therapeutic branch , n = 57 ) and patients requiring venous thromboembolism ( VTE ) prophylaxis after arterial vascular surgery or major lower-extremity amputations ( prophylactic branch , n = 57 ) were randomized to receive generic or branded enoxaparin for up to seven days .


Enoxaparin activity was measured by estimating blood anti-factor Xa levels at the peak plasma concentration .


As secondary outcomes , development or progression of VTE events , major adverse events and major bleeding events were considered for efficacy and safety comparisons .


DVT therapy : twenty-five patients received generic enoxaparin while 32 received branded enoxaparin ( subcutaneous , 1 mg/kg BID ) .


Mean percentages of anti-factor Xa levels within the target ranges were 62 35.4 % and 67.5 24.7 % , respectively ( p = .035 for non-inferiority ) .


No patient presented DVT progression , clinically detectable pulmonary embolism , or major bleeding events in any subgroup .


DVT prophylaxis : Thirty patients received generic enoxaparin and 27 received branded enoxaparin ( subcutaneous , 40 mg/day ) .


Mean percentages of anti-factor Xa levels within the target ranges were 77.9 30.9 % and 77.8 32.9 % , respectively ( p = .009 for non-inferiority ) .


There were no cases of VTE or major bleeding events in any subgroup .


generic and branded enoxaparins exhibited similar in vivo responses as measured by the anti-factor Xa activity , as well as similar clinical efficacy and safety outcomes .


Kidney function gradually decreases with age , and myocardial infarction accelerates this deterioration .


Omega-3 ( n-3 ) fatty acids may slow down the decline of kidney function .


The effect of marine and plant-derived n-3 fatty acids on kidney function in patients after myocardial infarction was examined .


In the Alpha Omega Trial , 2344 patients with history of myocardial infarction ages 60-80 years old ( 81 % men ) were randomized to one of four trial margarines .


The patients received an additional targeted amount of 400 mg/d eicosapentaenoic acid and docosahexaenoic acid , 2 g/d - linolenic acid , eicosapentaenoic acid-docosahexaenoic acid plus - linolenic acid , or placebo for 40 months .


Serum cystatin C and serum creatinine were assessed at baseline and after 40 months .


Creatinine-cystatin C-based GFR was estimated with the Chronic Kidney Disease Epidemiology Collaboration equation .


Patients consumed 19.9 g margarine/d , providing an additional 239 mg/d eicosapentaenoic acid with 159 mg/d docosahexaenoic acid , 1.99 g/d - linolenic acid , or both in the active treatment groups .


After 40 months , compared with baseline , mean ( SD ) creatinine-cystatin C-based GFR was -6.9 ( 12.6 ) , -4.8 ( 13.4 ) , -6.2 ( 12.8 ) , and -6.0 ( 13.0 ) ml/min per 1.73 m ( 2 ) in the placebo , eicosapentaenoic acid-docosahexaenoic acid , - linolenic acid , and eicosapentaenoic acid-docosahexaenoic acid plus - linolenic acid groups , respectively .


After 40 months , in patients receiving eicosapentaenoic acid-docosahexaenoic acid compared with placebo , the decline in creatinine-cystatin C-based GFR was 2.1 less ( 95 % confidence interval , 0.6 to 3.6 ; P < 0.01 ) ml/min per 1.73 m ( 2 ) ; other comparisons were not statistical significant .


Odds ratios ( 95 % confidence intervals ) of incident CKD ( < 60 ml/min per 1.73 m ( 2 ) ) and rapid decline of kidney function ( 3 ml/min per year ) for eicosapentaenoic acid-docosahexaenoic acid compared with placebo were 0.83 ( 0.58 to 1.18 ) and 0.85 ( 0.67 to 1.08 ) , respectively .


Long-term supplementation with 400 mg/d eicosapentaenoic acid-docosahexaenoic acid provides a small beneficial effect on kidney function in patients with a history of myocardial infarction .


Many service members do not seek care for mental health and addiction problems , often with serious consequences for them , their families , and their communities .


This study tested the effectiveness of a brief , telephone-based , cognitive-behavioral intervention designed to improve treatment engagement among returning service members who screened positive for posttraumatic stress disorder ( PTSD ) .


Service members who had served in Operation Enduring Freedom or Operation Iraqi Freedom who screened positive for PTSD but had not engaged in PTSD treatment were recruited ( N = 300 ) , randomly assigned to either control or intervention conditions , and administered a baseline interview .


Intervention participants received a brief cognitive-behavioral therapy intervention ; participants in the control condition had access to usual services .


All participants received follow-up phone calls at months 1 , 3 , and 6 to assess symptoms and service utilization .


Participants in both conditions had comparable rates of treatment engagement and PTSD symptom reduction over the course of the six-month trial , but receiving the telephone-based intervention accelerated service utilization ( treatment engagement and number of sessions ) and PTSD symptom reduction .


A one-time brief telephone intervention can engage service members in PTSD treatment earlier than conventional methods and can lead to immediate symptom reduction .


There were no differences at longer-term follow-up , suggesting the need for additional intervention to build upon initial gains .


To evaluate whether dietary intake of luteiin/zeaxanthin and B vitamins is associated with cataract prevalence and incidence .


Clinic-based , baseline cross-sectional and prospective cohort study designs .


Three thousand one hundred fifteen patients ( 6129 eyes ) enrolled in the Age-Related Eye Disease Study 55 to 80 years of age followed up for mean of 9.6 years .


Participants completed baseline food frequency questionnaires .


Baseline and annual lens photographs were graded centrally .


Multivariate models controlling for previously identified risk factors for cataracts tested for the association of cataracts with reported dietary intake , using the lowest quintile as reference .


Cataract surgery , cataract status ( type and severity ) at baseline , and development of cataracts .


At baseline , increased dietary riboflavin and B12 were associated inversely with nuclear and cortical lens opacities .


In comparisons of persons with and without cataract , persons with the highest riboflavin intake versus those with the lowest intake had the following associations : mild nuclear cataract : odds ratio ( OR ) , 0.78 ; 95 % confidence interval ( CI ) , 0.63-0 .97 ; moderate nuclear cataract : OR , 0.62 ; 95 % CI , 0.43-0 .90 ; and mild cortical cataract : OR , 0.80 ; 95 % CI , 0.65-0 .99 .


For B12 , the results were : mild nuclear cataract : OR , 0.78 ; 95 % CI , 0.63-0 .96 ; moderate nuclear cataract : OR , 0.62 ; 95 % CI , 0.43-0 .88 ; and mild cortical cataract : OR , 0.77 ; 95 % CI , 0.63-0 .95 .


Highest dietary B6 intake was associated with a decreased risk of moderate nuclear lens opacity developing compared with the lowest quintile ( OR , 0.67 ; 95 % CI , 0.45-0 .99 ) .


Highest dietary intake levels of niacin and B12 were associated with a decreased risk of development of mild nuclear or mild cortical cataracts in participants not taking Centrum ( Pfizer , New York , NY ) multivitamins .


For participants taking multivitamins during the study , the highest intake of dietary folate was associated with an increased risk of mild posterior subcapsular lens opacity development .


No statistically significant associations were found between lutein plus zeaxanthin intake and presence at baseline or development of nuclear or cortical lens opacity outcomes .


These findings are consistent with earlier studies suggesting that dietary intake of B vitamins may affect the occurrence of age-related lens opacities .


Further investigations are warranted .


Latrodectism is the most important spider envenomation syndrome worldwide .


There remains considerable controversy over antivenom treatment .


We aimed to investigate whether antivenom resulted in resolution of pain and systemic effects in patients with latrodectism who received standardized analgesia .