mRNA expression levels of T-bet were greater in the immunonutrition group than in the control group ( P < .05 ) .


Serum eicosapentaenoic acid and eicosapentaenoic acid/arachidonic acid ratios were greater in the immunonutrition group than in the control group ( P < .05 ) .


The levels of plasma PGE2 were lesser in the immunonutrition group than in the control group ( P < .05 ) .


Preoperative immunonutrition modulates PGE2 production and T-cell differentiation and may protect against the aggravation of operative complications in patients undergoing pancreatoduodenectomy .


To determine if sleep talkers with REM sleep behavior disorder ( RBD ) would utter during REM sleep sentences learned before sleep , and to evaluate their verbal memory consolidation during sleep .


Eighteen patients with RBD and 10 controls performed two verbal memory tasks ( 16 words from the Free and Cued Selective Reminding Test and a 220-263 word long modified Story Recall Test ) in the evening , followed by nocturnal video-polysomnography and morning recall ( night-time consolidation ) .


In 9 patients with RBD , daytime consolidation ( morning learning/recall , evening recall ) was also evaluated with the modified Story Recall Test in a cross-over order .


Two RBD patients with dementia were studied separately .


Sleep talking was recorded using video-polysomnography , and the utterances were compared to the studied texts by two external judges .


Sleep-related verbal memory consolidation was maintained in patients with RBD ( +2436 % words ) as in controls ( +918 % , p = 0.3 ) .


The two demented patients with RBD also exhibited excellent nighttime consolidation .


The post-sleep performance was unrelated to the sleep measures ( including continuity , stages , fragmentation and apnea-hypopnea index ) .


Daytime consolidation ( -919 % ) was worse than night-time consolidation ( +2945 % , p = 0.03 ) in the subgroup of 9 patients with RBD .


Eleven patients with RBD spoke during REM sleep and pronounced a median of 20 words , which represented 0.0003 % of sleep with spoken language .


A single patient uttered a sentence that was judged to be semantically ( but not literally ) related to the text learned before sleep .


Verbal declarative memory normally consolidates during sleep in patients with RBD .


The incorporation of learned material within REM sleep-associated sleep talking in one patient ( unbeknownst to himself ) at the semantic level suggests a replay at a highly cognitive creative level .


This is a randomized comparative study of the efficacy of celecoxib and loxoprofen in patients with frozen shoulder ( scapulohumeral periarthritis ) .


Patients with frozen shoulder who presented with pain as the symptom were divided at random into a celecoxib treatment group ( 100 mg/dose , twice daily ; n = 37 ) and a loxoprofen treatment group ( 60 mg/dose , 3 times daily ; n = 33 ) .


Medication was continued for 1-2 weeks in each group .


Each patient was asked to rate the pain on a visual analog scale ( score 0-5 ) .


This score significantly improved ( indicating marked alleviation of pain ) in both the celecoxib group ( from 3.41 0.86 before treatment to 2.30 1.02 after treatment ) and the loxoprofen group ( from 3.73 0.67 before treatment to 2.76 0.96 after treatment ) .


In the analysis of disappearance of pain , the percentage of patients showing disappearance of nocturnal pain was significantly higher in the celecoxib group ( 71.4 % ) than in the loxoprofen group ( 36.8 % ) .


The results confirm that celecoxib is comparable to loxoprofen in terms of analgesic efficacy in patients with frozen shoulder .


Among other findings , we report that celecoxib was more effective for nocturnal pain than loxoprofen .


Prescription opioid dependence is increasing and creates a significant public health burden , but primary care physicians lack evidence-based guidelines to decide between tapering doses followed by discontinuation of buprenorphine hydrochloride and naloxone hydrochloride therapy ( hereinafter referred to as buprenorphine therapy ) or ongoing maintenance therapy .


To determine the efficacy of buprenorphine taper vs ongoing maintenance therapy in primary care-based treatment for prescription opioid dependence .


We conducted a 14-week randomized clinical trial that enrolled 113 patients with prescription opioid dependence from February 17 , 2009 , through February 1 , 2013 , in a single primary care site .


Patients were randomized to buprenorphine taper ( taper condition ) or ongoing buprenorphine maintenance therapy ( maintenance condition ) .


The buprenorphine taper was initiated after 6 weeks of stabilization , lasted for 3 weeks , and included medications for opioid withdrawal , after which patients were offered naltrexone treatment .


The maintenance group received ongoing buprenorphine therapy .


All patients received physician and nurse support and drug counseling .


Illicit opioid use via results of urinanalysis and patient report , treatment retention , and reinitiation of buprenorphine therapy ( taper group only ) .


During the trial , the mean percentage of urine samples negative for opioids was lower for patients in the taper group ( 35.2 % [ 95 % CI , 26.2 % -44.2 % ] ) compared with those in the maintenance group ( 53.2 % [ 95 % CI , 44.3 % -62.0 % ] ) .


Patients in the taper group reported more days per week of illicit opioid use than those in the maintenance group once they were no longer receiving buprenorphine ( mean use , 1.27 [ 95 % CI , 0.60-1 .94 ] vs 0.47 [ 95 % CI , 0.19-0 .74 ] days ) .


Patients in the taper group had fewer maximum consecutive weeks of opioid abstinence compared with those in the maintenance group ( mean abstinence , 2.70 [ 95 % CI , 1.72-3 .75 ] vs 5.20 [ 95 % CI , 4.16-6 .20 ] weeks ) .


Patients in the taper group were less likely to complete the trial ( 6 of 57 [ 11 % ] vs 37 of 56 [ 66 % ] ; P < .001 ) .


Sixteen patients in the taper group reinitiated buprenorphine treatment after the taper owing to relapse .


Tapering is less efficacious than ongoing maintenance treatment in patients with prescription opioid dependence who receive buprenorphine therapy in primary care .


clinicaltrials.gov Identifier : NCT00555425 .


The OX40/OX40L interaction contributes to an optimal T cell response following allergic stimuli and plays an important role in the maintenance and reactivation of memory T effector cells .


We tested whether treatment with an anti-OX40L monoclonal antibody ( MAb ) would inhibit allergen-induced responses in subjects with asthma .


Twenty-eight mild , atopic asthmatic subjects were recruited for a double-blind , randomized , placebo-controlled , parallel-group trial ( ClinicalTrials.gov identifier NCT00983658 ) to compare blockade of OX40L using a humanized anti-OX40L MAb to placebo-administered intravenously in 4 doses over 3 months .


Allergen inhalation challenges were carried out 56 and 113 days after the first dose of study drug .


The primary outcome variable was the late-phase asthmatic response .


Other outcomes included the early-phase asthmatic response , airway hyperresponsiveness , serum IgE levels , blood and sputum eosinophils , safety and tolerability .


Treatment with anti-OX40L MAb did not attenuate the early - or late-phase asthmatic responses at days 56 or 113 compared with placebo .


In the anti-OX40L MAb treatment group , total IgE was reduced 17 % from pre-dosing levels , and sputum eosinophils decreased 75 % by day 113 ( both P = 0.04 ) .


There was no effect of anti-OX40L MAb on airway hyperresponsiveness or blood eosinophils .


The frequency of AEs was similar in both groups .


Pharmacological activity of anti-OX40L MAb was observed by decreases in serum total IgE and airway eosinophils at 16 weeks post-dosing , but there was no effect on allergen-induced airway responses .


It is possible that the treatment duration or dose of antibody was insufficient to impact the airway responses .


The aim of this study was to determine the efficacy and tolerability of hydromorphone extended release ( ER ) in patients with chronic low back pain ( LBP ) with or without a neuropathic component .


This was a post hoc analysis of data from a multicenter , double-blind , placebo-controlled clinical trial using a randomized withdrawal design , performed in patients with moderate to severe chronic LBP .


Patients achieving stable doses of hydromorphone ER during a 2 - to 4-week conversion and titration phase were randomized to continue treatment with hydromorphone ER or taper-down to placebo during a 12-week double-blind phase .


The primary efficacy outcome was the mean change in 11-point Numeric Rating Scale ( NRS ) pain intensity score from randomization to the final visit of the double-blind phase .


Tolerability was assessed by recording adverse events ( AEs ) .


Data were analyzed separately for patients with non-neuropathic and neuropathic LBP .


A total of 173 patients with non-neuropathic/nociceptive LBP and 94 with neuropathic LBP were randomized into the double-blind phase .


During the conversion and titration phase , mean ( SD ) NRS scores decreased significantly from 6.5 ( 1.87 ) and 6.4 ( 1.99 ) at screening to 3.3 ( 0.98 ) and 3.2 ( 1.05 ) , respectively .


For both LBP subgroups , patients randomized to hydromorphone ER maintained this improvement over the double-blind treatment period , whereas those randomized to placebo reported significant increase in NRS scores .


Across subgroups , the incidence of 1 or more AE was 54 percent to 57 percent in the conversion and titration phase and 47 percent to 55 percent in the double-blind phase .


The results of this study indicate that hydromorphone ER is efficacious and generally well tolerated in the management of patients with non-neuropathic and neuropathic chronic LBP .


Low-dose CT screening is recommended for individuals at high risk of developing lung cancer .


However , CT screening does not detect all lung cancers : some might be missed at screening , and others can develop in the interval between screens .


The NELSON trial is a randomised trial to assess the effect of screening with increasing screening intervals on lung cancer mortality .


In this prespecified analysis , we aimed to assess screening test performance , and the epidemiological , radiological , and clinical characteristics of interval cancers in NELSON trial participants assigned to the screening group .


Eligible participants in the NELSON trial were those aged 50-75 years , who had smoked 15 or more cigarettes per day for more than 25 years or ten or more cigarettes for more than 30 years , and were still smoking or had quit less than 10 years ago .


We included all participants assigned to the screening group who had attended at least one round of screening .


Screening test results were based on volumetry using a two-step approach .


Initially , screening test results were classified as negative , indeterminate , or positive based on nodule presence and volume .


Subsequently , participants with an initial indeterminate result underwent follow-up screening to classify their final screening test result as negative or positive , based on nodule volume doubling time .


We obtained information about all lung cancer diagnoses made during the first three rounds of screening , plus an additional 2 years of follow-up from the national cancer registry .


We determined epidemiological , radiological , participant , and tumour characteristics by reassessing medical files , screening CTs , and clinical CTs .


The NELSON trial is registered at www.trialregister.nl , number ISRCTN63545820 .


15,822 participants were enrolled in the NELSON trial , of whom 7915 were assigned to low-dose CT screening with increasing interval between screens , and 7907 to no screening .


We included 7155 participants in our study , with median follow-up of 816 years ( IQR 756-856 ) .


187 ( 3 % ) of 7155 screened participants were diagnosed with 196 screen-detected lung cancers , and another 34 ( < 1 % ; 19 [ 56 % ] in the first year after screening , and 15 [ 44 % ] in the second year after screening ) were diagnosed with 35 interval cancers .


For the three screening rounds combined , with a 2-year follow-up , sensitivity was 846 % ( 95 % CI 796-892 ) , specificity was 986 % ( 95 % CI 985-988 ) , positive predictive value was 404 % ( 95 % CI 359-447 ) , and negative predictive value was 998 % ( 95 % CI 998-999 ) .


Retrospective assessment of the last screening CT and clinical CT in 34 patients with interval cancer showed that interval cancers were not visible in 12 ( 35 % ) cases .


In the remaining cases , cancers were visible when retrospectively assessed , but were not diagnosed because of radiological detection and interpretation errors ( 17 [ 50 % ] ) , misclassification by the protocol ( two [ 6 % ] ) , participant non-compliance ( two [ 6 % ] ) , and non-adherence to protocol ( one [ 3 % ] ) .


Compared with screen-detected cancers , interval cancers were diagnosed at more advanced stages ( 29 [ 83 % ] of 35 interval cancers vs 44 [ 22 % ] of 196 screen-detected cancers diagnosed in stage III or IV ; p < 00001 ) , were more often small-cell carcinomas ( seven [ 20 % ] vs eight [ 4 % ] ; p = 0003 ) and less often adenocarcinomas ( nine [ 26 % ] vs 102 [ 52 % ] ; p = 0005 ) .


Lung cancer screening in the NELSON trial yielded high specificity and sensitivity , with only a small number of interval cancers .


The results of this study could be used to improve screening algorithms , and reduce the number of missed cancers .


Zorgonderzoek Nederland Medische Wetenschappen and Koningin Wilhelmina Fonds .


Despite the beneficial effect of cardiac rehabilitation after myocardial infarction , a rehabilitation program to improve cardiorespiratory fitness and influence secondary prevention has not been implemented for ischemic stroke and transient ischemic attack ( TIA ) .


To investigate the safety and feasibility of a post-stroke care including an exercise program after minor ischemic stroke or TIA .


In a randomised controlled trial , 20 patients with a recent minor stroke or TIA without cardiac contraindications were randomly assigned to one of the two interventions ; post-stroke care without exercise or post-stroke care with exercise .


Patients were evaluated at baseline , 6 and 12 months .


Eighteen patients completed the intervention .


In none of the patients cardiopulmonary contraindications for the maximal exercise test and exercise program were found .


No cardiovascular events occurred during the maximal exercise tests and exercise program .


After one year , significantly more patients in the post-stroke care with exercise group achieved the composite endpoint of optimal medical therapy .


Post-stroke care including an exercise program is safe and feasible in the acute phase after minor stroke or TIA and might be a way to increase effectiveness of secondary stroke prevention .


We are currently conducting a larger trial to validate these results .


40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI .


Periodontal parameters , glycosylated haemoglobin ( HbA1c ) and high-sensitivity C-reactive protein ( hs-CRP ) were evaluated at baseline , 2 - and 3-months intervals .


15 subjects from NSPT group and 17 from OHI group completed the study .


The difference in plaque index ( PI ) between NSPT and OHI groups were significant at 2 months recall ( p = 0.013 ) .


There was no significant difference between NSPT and OHI group for all other clinical periodontal parameters , HbA1c and CRP levels .


At 3 months post-therapy , periodontal parameters improved significantly in both groups with sites with probing pocket depth ( PPD ) < 4 mm reported as 98 1.8 % in NSPT group and 92 14.9 % in OHI group .


Mean PPD and mean probing attachment loss ( PAL ) within the NSPT group reduced significantly from baseline ( 2.56 0.57 mm , 3.35 0.83 mm ) to final visit ( 1.94 0.26 mm , 2.92 0.72 mm ) ( p = 0.003 , p < 0.001 ) .


For OHI group , improvements in mean PPD and mean PAL were also seen from baseline ( 2.29 0.69 mm , 2.79 0.96 mm ) to final visit ( 2.09 0.72 mm , 2.62 0.97 mm ) ( p < 0.001 for both ) .


Similarly , HbA1c levels decreased in both groups with NSPT group recording statistically significant reduction ( p = 0.038 ) .


Participants who demonstrated 50 % reduction in PPD showed significant reductions of HbA1c and hs-CRP levels ( p = 0.004 and p = 0.012 ) .


NSPT significantly reduced PI at 2 months post-therapy as compared to OHI .


Both NSPT and OHI demonstrated improvements in other clinical parameters as well as HbA1c and CRP levels .


ClinicalTrials.gov : NCT01951547 .


The early management of orthopaedic outpatients by physiotherapists may be useful in reducing public hospital waiting lists .


Physiotherapists in Australia are prevented by legislation and funding models from investigating , prescribing , injecting and referring autonomously .


This gap in service is particularly noticeable in the management of shoulder pain in early-access physiotherapy services , as patients needing corticosteroid injection face delays or transfer to other services for this procedure .


This trial will investigate the clinical ( decision making and outcomes ) and economic feasibility of a physiotherapist prescribing and delivering corticosteroid and local anaesthetic injections for shoulder pain in an Australian public hospital setting .


A double-blinded ( patient and assessor ) non-inferiority randomised controlled trial will compare an orthopaedic surgeon and a physiotherapist prescribing and delivering corticosteroid injections to the shoulder .


Agreement in decision making between the two clinicians will be investigated , and economic information will be obtained for estimating disease burden and an economic evaluation .


The surgeon and the physiotherapist will independently assess patients , and 64 eligible participants will be randomised to receive subacromial injection of corticosteroid and local anaesthetic from either the surgeon or the physiotherapist .


Post-injection , all participants will receive physiotherapy .


The primary outcome measure will be the Shoulder Pain and Disability Index measured at baseline , and at 6 and 12weeks post-injection .


Analysis will be conducted on an intention-to-treat basis and compared to a per-protocol analysis .


A cost-utility analysis will be undertaken from the perspective of the health funder .


Findings will assist policy makers and services in improving access for orthopaedic patients .


Australia and New Zealand Clinical Trials Registry : 12612000532808 First registered : 21 May 2012 .


First participant randomized : 16 January 2013 .


Intestinal inflammation is a hallmark of cystic fibrosis ( CF ) .


Administration of probiotics can reduce intestinal inflammation and the incidence of pulmonary exacerbations .


We investigated the composition of intestinal microbiota in children with CF and analyzed its relationship with intestinal inflammation .


We also investigated the microflora structure before and after Lactobacillus GG ( LGG ) administration in children with CF with and without antibiotic treatment .


The intestinal microbiota were analyzed by denaturing gradient gel electrophoresis ( DGGE ) , real-time polymerase chain reaction ( RT-PCR ) , and fluorescence in situ hybridization ( FISH ) .


Intestinal inflammation was assessed by measuring fecal calprotectin ( CLP ) and rectal nitric oxide ( rNO ) production in children with CF as compared with healthy controls .


We then carried out a small double-blind randomized clinical trial with LGG .


Twenty-two children with CF children were enrolled in the study ( median age , 7 years ; range , 2-9 years ) .


Fecal CLP and rNO levels were higher in children with CF than in healthy controls ( 184146 g/g vs. 5246 g/g ; 1815 vs. 2.61.2 mol/L NO2 ( - ) , respectively ; P < 0.01 ) .


Compared with healthy controls , children with CF had significantly different intestinal microbial core structures .


The levels of Eubacterium rectale , Bacteroides uniformis , Bacteroides vulgatus , Bifidobacterium adolescentis , Bifidobacterium catenulatum , and Faecalibacterium prausnitzii were reduced in children with CF. A similar but more extreme pattern was observed in children with CF who were taking antibiotics .


LGG administration reduced fecal CLP and partially restored intestinal microbiota .


There was a significant correlation between reduced microbial richness and intestinal inflammation .


CF causes qualitative and quantitative changes in intestinal microbiota , which may represent a novel therapeutic target in the treatment of CF. Administration of probiotics restored gut microbiota , supporting the efficacy of probiotics in reducing intestinal inflammation and pulmonary exacerbations .


ClinicalTrials.gov NCT 01961661 .


To investigate the therapeutic effects of a manual therapy protocol for improving pain , function , pressure pain thresholds ( PPT ) , quality of sleep , and depressive symptoms in women and men with fibromyalgia syndrome ( FMS ) .


Eighty-nine patients were randomly assigned to experimental or control group .


The experimental group ( 24 female , 21 male ) received 5 sessions of manual therapy and the control group ( 24 female , 21 male ) did not receive any intervention .


PPT , pain , impact of FMS symptoms , quality of sleep , and depressive symptoms were assessed in both groups at baseline and after 48 hours of the last intervention in the experimental group .


The analysis of covariance found significant GroupTimeSex interactions for McGill PPI and Center for Epidemiologic Studies Depressive Symptoms Scale ( P < 0.01 ) was also found : men exhibited a larger effect size for depressive symptoms than women , whereas women exhibited a greater effect size than men in the McGill PPI .


A significant GroupTimeSex interaction for PPT over suboccipital , upper trapezius , supraspinatus , second rib , gluteal region , and tibialis anterior muscle was also found : men included in the experimental group experienced significant greater improvements in PPT as compared with women with FMS in the experimental group .


Manual therapy protocol was effective for improving pain intensity , widespread pressure pain sensitivity , impact of FMS symptoms , sleep quality , and depressive symptoms .


In addition , sex differences were observed in response to treatment : women and men get similar improvements in quality of sleep and tender point count , whereas women showed a greater reduction in pain and impact of FMS symptoms than men , but men reported higher decreases in depressive symptoms and pressure hypersensitivity than women .


This study tested the effects of two fundamental forms of distraction , including visual-manual and cognitive-audio distraction , with comparison under both operational and tactical driving .


Strategic control remains for future study .


Driving is a complex control task involving operational , tactical , and strategic control .


Although operational control , such as lead-car following , has been studied , the influence of in-vehicle distractions on higher levels of control , including tactical and strategic , remains unclear .


Two secondary tasks were designed to independently represent visual-manual and cognitive-audio distractions , based on multiple resource theory .


Drivers performed operational vehicle control maneuvers ( lead-car following ) or tactical control maneuvers ( passing ) along with the distraction tasks in a driving simulator .


Response measures included driving performance and visual behavior .


Results revealed drivers ' ability to accommodate either visual or cognitive distractions in following tasks but not in passing .


The simultaneous distraction condition led to the greatest decrement in performance .


Findings support the need to assess the impacts of in-vehicle distraction on different levels of driving control .


Future study should investigate driver distraction under strategic control .


The PARAMOUNT Phase III trial showed that maintenance pemetrexed after pemetrexed plus cisplatin induction was well tolerated and effective for patients with advanced nonsquamous non-small-cell lung cancer .


Approximately 17 % of patients receiving maintenance therapy in this study were 70 years of age or older .


Here we report efficacy and safety results from the PARAMOUNT study for elderly ( 70 years ) and non-elderly ( < 70 years ) patients .


Final efficacy and safety data from the PARAMOUNT study were analyzed post hoc using subgroup analyses for elderly and non-elderly patients .


The median age was 73 years in the elderly subgroup ( n = 92 ) and 60 years in the non-elderly subgroup ( n = 447 ) .


Subgroups had similar baseline characteristics , except for a higher percentage of males and patients with a performance status of one in the elderly subgroup .


For elderly patients , the median PFS was 6.4 months for pemetrexed and 3.0 months for placebo ; the median OS was 13.7 months for pemetrexed and 12.1 months for placebo .


For non-elderly patients , the median PFS was 4.0 months for pemetrexed and 2.8 months for placebo ; the median OS was 13.9 months for pemetrexed and 10.8 months for placebo .


Elderly patients experienced similar levels of low-grade toxicities , but had a higher percentage of grade 3/4 anemia and neutropenia than non-elderly patients , although importantly , this did not translate into increased febrile neutropenia .


Continuation maintenance pemetrexed had comparable survival and toxicity profiles in the elderly and non-elderly subgroups .


However , grade 3/4 anemia and neutropenia were numerically higher for elderly patients .


Ticagrelor is a reversibly binding and selective P2Y12 - receptor antagonist approved for the prevention of atherothrombotic events in patients with acute coronary syndromes .


As bleeding events remain a hazard with antiplatelet therapy , this study investigated the effect of the vasopressin agonist , desmopressin , on ticagrelor-induced bleeding time prolongation .


Desmopressin has previously been shown to improve primary haemostasis and is widely used as first-line therapy for individuals with bleeding disorders .


In a randomized , double-blind , 2-period crossover study , healthy volunteers received ticagrelor ( 270mg loading dose ; 180mgbid ) for 5days .


On Day 5 , desmopressin ( 03g/kg ) or saline intravenous infusions were administered .


The impact of desmopressin on bleeding time , inhibition of platelet aggregation ( IPA ) , platelet function and ticagrelor pharmacokinetic parameters was investigated .


Twenty-one volunteers ( 81 % male ) were enrolled .


Median [ range ] bleeding times were slightly reduced with ticagrelor plus desmopressin compared with ticagrelor alone ( 750 [ 3-17 ] vs. 1050 [ 3-25 ] min at 25h ) .


Median reductions in bleeding time from baseline were generally similar between ticagrelor plus desmopressin compared with ticagrelor alone at all time points .


Co-administration of desmopressin had no impact on IPA , although platelet reactivity was significantly increased ( von Willebrand Factor antigen : GLS mean AUEC was 4667 % .


h for ticagrelor plus desmopressin compared with 2750 % .


h for ticagrelor alone ) .


Desmopressin did not influence the pharmacokinetics of ticagrelor .


Desmopressin had no significant effect on bleeding time or inhibition of platelet aggregation by ticagrelor , although primary haemostatic activity was significantly increased .


Ticagrelor pharmacokinetic parameters were not affected by co-administration with desmopressin .


Therefore , desmopressin is unlikely to be an effective therapeutic agent for control of the potential bleeding events associated with ticagrelor .


Sedation with dexmedetomidine may facilitate ventilator liberation and limit the occurrence of delirium .


No trial has assessed patient recall or the development of psychological outcomes after dexmedetomidine sedation .


This pilot study evaluated whether transitioning benzodiazepine sedation to dexmedetomidine alters patient recall and the incidence of anxiety , depression , or acute stress disorder ( ASD ) .


This investigation was a randomized , double-blind , single-center study .


Existing continuous benzodiazepine sedation was converted to dexmedetomidine or midazolam when patients qualified for daily awakenings .


Sedation was titrated to achieve Riker sedation agitation scores of 3 to 4 .


The intensive care unit ( ICU ) Stressful Experiences Questionnaire , hospital anxiety and depression scale , and the impact of event scale-revised were administered before hospital discharge to assess recall , anxiety , depression , and manifestations of ASD .


A total of 11 patients received dexmedetomidine , and 12 patients received midazolam .


Median dosing was 0.61 g/kg/h for 3.5 days for dexmedetomidine and 3.7 mg/h for 3 days for midazolam .


Attainment of goal sedation and analgesia was similar ; however , more dexmedetomidine patients experienced agitation and pain .


The median duration of mechanical ventilation from study drug initiation to extubation was 3.4 days in dexmedetomidine patients and 2.9 days in midazolam patients .


Dexmedetomidine patients remembered 18.5 experiences compared with 8.5 in midazolam patients ( P = .015 ) .


Rates of anxiety and depression were similar .


In all , 5 ( 62.5 % ) dexmedetomidine patients and 1 ( 12.5 % ) midazolam patient manifested ASD ( P = .063 ) , and 1 dexmedetomidine patient and 5 midazolam patients developed new-onset delirium ( P = .07 ) .


Hypotension occurred in 10 ( 90.9 % ) dexmedotomidine patients and 6 ( 50 % ) midazolam patients ( P = .069 ) .


Transitioning benzodiazepine sedation to dexmedetomidine when patients qualify for daily awakenings may reduce the development of delirium and facilitate remembrance of ICU experiences but may lead to manifestations of ASD .


Monitoring hypotension is required for both the sedatives .


Additional comparative studies focusing on the long-term impact of ICU recall and psychological outcomes are needed .


We investigated the efficacy of concurrent chemoradiotherapy ( CCRT ) over radiotherapy ( RT ) in Chinese patients with locally advanced cervical carcinoma .


Between January 2005 and January 2008 , 192 patients with squamous cell carcinoma of the cervix were included in the study : 96 in arm A ( CCRT with 20 mg/m2 cisplatin for 5 days ) and 96 in arm B ( RT ) .


The overall response rate was the primary endpoint .


The secondary endpoints included overall survival , progression-free survival , and toxicity .


The 5-year overall response rate was 67 % and 53 % for the CCRT and RT arms , respectively , and the difference was statistically significant , while the median overall survival was 68 months ( range 3-85 months ) and 61 months ( range 4-83 months ) , respectively ( P = 0.009 ) .


In addition , the median progression-free survival for CCRT was 62 months ( range 3-83 months ) , whereas it was 51 months ( range 4-81 months ) for the RT arm ( P = 0.025 ) .


The toxicity profile , both acute and late , was comparable in both arms .


In summary , we demonstrate that CCRT was effective and better tolerated than RT alone in Chinese patients with locally advanced cervical carcinoma .


Chinese Clinical Trials Register : ChiCTR-TRC-13003979 .


To investigate an effectiveness of walking exercise program applying the Theory of Planned Behavior in people at risk of hypertension in Samut Sakorn province .


The present study is a quasi-experimental research .


The inclusion criteria were people aged 35-59 years old , systolic blood pressure 120-139 mmHg , and diastolic blood pressure 80-89 mmHg .


Participants were randomly selected into the experimental group ( n = 34 ) and the comparison group ( n = 34 ) .


The experimental group received activities including health information , benefits of walking exercise , group discussion in exercise barriers , modeling and experience exchange , walking exercise practice , and practice on using walking monitoring booklet at the baseline and the 2nd week , whereas the comparison group received only health information and the booklet practice at the beginning of the intervention .


Data were collected by self-administered questionnaires at the baseline , 2nd week , and 6th week .


Statistical analysis was performed using Chi-square , Independent t-test , and repeated measures ANOVA .


The experimental group made significant improvements in attitude towards walking exercise , perceived behavior control , subjective norm , walking exercise intention , and walking exercise over time ( p < 0.05 ) .


However , no statistically significant differences between the experimental and the comparison groups were found in subjective norm , systolic and diastolic blood pressure from baseline to the 6th week .


The experimental group had a significant higher mean difference score of attitude towards walking exercise , perceived behavior control , walking exercise intention , walking exercise , weight , and BMI compared to those in the comparison group ( p < 0.05 ) .


Subjective norm scores in the experimental group were more likely to increase from baseline to the 6th week , but not a significant difference .


Walking exercise programs applying the Theory of Planned Behavior should be recommended in people at risk of hypertension .


Health professionals should also be motivated to practice with this program .


Alcohol consumption has substantially increased in China during the last 3 decades .


Socioeconomic status ( SES ) most likely influences the development of alcoholic liver disease ( ALD ) in Chinese people who excessively consume alcohol .


At the present time , however , little information is available in this field .


The objectives of this study were to investigate the population-based prevalence of ALD and to identify the correlation of socioeconomics with the development of ALD .


A cross-sectional survey was conducted in 8,186 individuals who resided in Shandong Province and were over 18 years old in 2011 using a randomized multistage clustered sampling approach .


Among these subjects , 7,295 ( 89.12 % ) were interviewed .


Questionnaires covered demographic characteristic , medical history , current medication , and health-relevant behavior , particularly alcohol consumption , dietary habit , and physical activity .


Anthropometric measurements , biochemical tests , and abdominal ultrasonography were also performed .


Among the 7,295 subjects , 624 ( 8.55 % ) were diagnosed with ALD .


The prevalence rate was significantly higher in males than in females ( 15.76 % in males vs. 1.42 % in females , p < 0.05 ) .


In this population , the risk of ALD was highest in the 40 - to 49-year-old group .


The incidence of ALD was highest in individuals who had a high level of occupation .


Individuals who had received a low level of education had the highest incidence of ALD .


Subjects with a low family income were more likely to have ALD than did those with an abundant family income .


Currently , unmarried individuals had a higher incidence of ALD in the overall population .


ALD is prevalent in north-eastern China .


SES correlates with the development of ALD .


Socioeconomic risk factors for ALD in north-eastern China include male gender , middle age , currently unmarried , low level of education , low family income , and high level of occupation .


When switching from usual brand cigarettes , very low nicotine content ( VLNC ) cigarettes lead to a reduction in the number of cigarettes smoked , toxicant exposure , withdrawal symptoms and dependence .


One area that has been relatively unexplored is what factors might moderate the effects of VLNC cigarettes .


This exploratory analysis focuses on sex differences in responses to VLNC cigarettes and nicotine replacement therapy .


An exploratory secondary analysis of a randomized trial of 235 participants ( 58 % female , mean age 47 years ) comparing a ) 0.05-0 .09 mg nicotine yield cigarettes ; b ) 21 mg nicotine patch and 3 ) 0.05-0 .09 nicotine yield cigarettes with 21 mg nicotine patch was conducted .


We focused on sex differences in product use , and impact of products on withdrawal response from usual brand cigarettes and abstinence by randomized group .


The combination of VLNC cigarettes and nicotine patch was more effective in reducing use of VLNC cigarettes and withdrawal symptoms among males than females , whereas females were equally responsive to VLNC cigarettes with and without the nicotine patch .


Females were more likely to quit smoking than males when assigned to either of the conditions that incorporated the VLNC cigarettes ; however , males were more likely to quit smoking in the nicotine patch alone condition than females .


Sex of the smoker may be an important determinant for effects of VLNC cigarettes and nicotine patch .


Future large randomized trials to confirm these results are needed .


This study investigated whether early intervention based on additional use of sidestream capnography could reduce the incidence of oxygen desaturation and hypoxic events in patients receiving propofol anesthesia during surgical abortion .


We recruited 704 ASAI-III female patients , 18-52 years old and scheduled for planned painless surgical abortion , and randomized them into a control group ( n = 359 ) receiving standard monitoring and an experimental group ( n = 341 ) receiving standard monitoring and additional capnography .


Exclusion criteria were preexisting cardiovascular disease , preexisting hypotension , bradycardia or arrhythmia , and drug allergy .


Anesthesia was induced in all patients with propofol using target-controlled infusion at a target propofol plasma concentration of 4 g/ml .


All patients received flurbiprofen axetil 50 mg and 0.5 g/kg fentanyl 5 min before anesthesia .


Bispectral index was used and maintained between 45 and 60 .


Main outcome measures were apnea or abnormal ventilation status , rate of oxygen desaturation , occurrence of hypoxia and severe hypoxia , and perioperative side effects .


The experimental group had significantly higher rate of apnea or abnormal ventilation , significantly lower rate of oxygen desaturation , and significant lower occurrence of hypoxia and severe hypoxia compared to the control group .


We found no statistically significant differences between the 2 groups in the rates of increased oxygen supplementation , assisted ventilation , bradycardia , hypotension , dosage of atropine , dosage of ephedrine or phenylephrine , and the amount of propofol consumed .


Sidestream capnographic monitoring improves early detection of alterations in ventilation parameters and reduces the incidence of oxygen desaturation and hypoxemia resulting from propofol anesthesia during surgical abortion .


Sympathetic response associated with laryngoscopy and endotracheal intubation is recognised as a potential cause for a number of complications especially in hypertensive patients .


Various methods have been used to attenuate these haemodynamic responses ; however most of the studies are in normotensive patients .


The aim of our study was to compare the effect of oral clonidine and 1/V fentanyl with oral placebo and I/V fentanyl in attenuating the haemodynamic responses to laryngoscopy and intubation in known hypertensive patients .


In a double blind randomised controlled trial .


60 hypertensive patients , taking antihypertensive drugs and with systolic blood pressure below 160 ( mmHg and diastolic blood pressure below 100 mmHg scheduled for elective surgeries , requiring oral endotracheal intubation and age ranging from 40-65 years were included in this study and randomly divided into Group A ( clonidine 0.2 mg + fentanyl 2 microg/Kg ) and Group B ( Placebo + fentanyl 2 microg/Kg ) .


Demographic data were comparable in both groups .


There were no statistically significant differences between the two groups in the duration of laryngoscopy and intubation .


There was statistically significant attenuation in heart rate in both groups ( p = 0.020 ) .


The trends of attenuation of systolic blood pressure , diastolic blood pressure and mean arterial pressure in Group A compared to Group B , were statistically significant ( p = 0.034 , 0.011 , 0.011 respectively ) .


Clonidine , under the present study design attenuates the haemodynamic response to laryngoscopy and endotracheal intubation in known hypertensive patients .


Borderline Personality Disorder ( BPD ) is a serious psychiatric condition associated with substantial mortality , burden and public health costs .


DBT is the treatment model with the largest number of published research articles showing effectiveness .


However , some patients are not sufficiently engaged in outpatient treatment while presenting severe parasuicidal behavior , making hospitalization necessary .


The Center for Personality Disorders Jelgersma developed an intensive 12-week inpatient DBT program that ( i ) rapidly reduces core borderline symptoms like suicidal behavior , ( ii ) minimizes the negative effects of an inpatient setting , and ( iii ) enhances compliance with outpatient treatment .


We evaluate the ( cost - ) effectiveness of this experimental program .


Seventy patients , aged 18 to 45years with a primary diagnosis of BPD , showing a chronic pattern of parasuicidal gestures and/or reporting high degrees of severity of other borderline symptoms , are randomly allocated to the control and intervention groups .


Subjects in the control group receive standard outpatient DBT , provided in one of three regular mental health settings in GGZ Rivierduinen .


Subjects in the intervention group receive 12weeks of intensified inpatient DBT plus six months of standard DBT , provided in the Center for Personality Disorders Jelgersma .


The primary outcome is the number of suicide attempts/self-harming acts .


Secondary outcomes are severity of other borderline complaints , quality of life , general psychopathological symptoms and health care utilization and productivity costs .


Data are gathered using a prospective , two ( group : intervention and control ) by five ( time of measurement ) repeated measures factorial design.Participants will complete three-monthly outcome assessments in the course of therapy : at baseline , and 12 , 24 , 36 and 52weeks after the start of the treatment .


The period of recruitment started in March 2012 and the study will end in December 2014 .


Highly suicidal outpatient patients can pose a dilemma for mental health care professionals .


Although hospitalization seems inevitable under some circumstances , it has proven to be harmful in its own right .


This paper outlines the background and methods of a randomized trial evaluating the possible surplus value of a short-term inpatient DBT program .


Poor CD4 lymphocyte recovery on antiretroviral therapy ( ART ) is associated with reduced function of the thymus .


Palifermin ( keratinocyte growth factor ) , by providing support to the thymic epithelium , promotes lymphopoiesis in animal models of bone marrow transplantation and graft-versus-host disease .


In AIDS Clinical Trials Group A5212 , a randomized , double-blind , placebo-controlled study , 99 HIV-infected patients on ART with plasma HIV-1 RNA levels 200 copies per milliliter for 6 months and CD4 lymphocyte counts < 200 cells per cubic milliliter were randomized 1:1:1:1 to receive once daily intravenous administration of placebo or 20 , 40 , or 60 g/kg of palifermin on 3 consecutive days .


The median change in the CD4 T-cell count from baseline to week 12 was not significantly different between the placebo arm [ 15 ( -16 , 23 ) cells/mm ] and the 20-g/kg dose [ 11 ( 2 , 32 ) cells/mm ] , the 40-g/kg dose [ 12 ( -2 , 25 ) cells/mm ] , or the 60-g/kg dose arm [ 8 ( -13 , 35 ) cells/mm ] of palifermin .


No significant changes were observed in thymus size or in the number of naive T cells or recent thymic emigrants .


Palifermin in the doses studied was not effective in improving thymic function and did not raise CD4 lymphocyte counts in HIV-infected patients with low CD4 cell counts despite virologically effective ART .


The Centers for Disease Control and Prevention highlights the importance of evaluating interventions rigorously and recommends evaluating new interventions against interventions with established efficacy .


Competencias para adolescentes con una sexualidad saludable ( COMPAS ) is a school-based HIV prevention program that has been shown to be effective in reducing sexual risk behaviors among adolescents in Spain .


This study evaluates the efficacy of COMPAS program compared with a Spanish-culture adapted version of Cudate !


( Take Care of Yourself ) , an evidence-based HIV prevention curriculum designed for Latino adolescents in the US .


This cluster randomized controlled trial involved 1,563 adolescents attending 18 public high schools located in 5 provinces of Spain .


The schools invited to participate were enrolled and randomly assigned to the three experimental conditions : COMPAS , Cudate !


, and control group ( CG ; no intervention ) .


Generalized estimating equation analyses revealed that both interventions improved attitudes toward people living with human immunodeficiency syndrome ( HIV ) / AIDS and the HIV test and increased HIV/sexually transmitted infection knowledge and intention to engage in safer sex behaviors compared with the CG .


Although only COMPAS increased participants ' sexual risk perception and attitude toward condom use compared with the CG , the two interventions did not significantly differ on any outcome .


When compared with an established program , COMPAS was at least as effective at increasing the intention to engage in safer sex behaviors as the evidence-based intervention .


Childbirth has been recognised as the most painful experience known to women .


This study aimed at studying the efficacy and safety of the single shot spinal analgesia for pain relief in labour .


One hundred and twelve parturients in labour were randomized into two groups of 55 paturients each .


Group B received 2.5 mg of spinal plain bupivacaine only while Group BF had 2.5 mg plain bupivacaine with 25 gg of fentanyl .


Onset of sensory block , time to achieve maximum sensory block , duration of sensory and motor block and the level of block were recorded .


The need for oxytocin augmentation , instrumental delivery , neonatal Apgar scores and umbilical artery blood pH were recorded .


The numeric rating pain scores for groups B and BF were significantly reduced from a mean prespinal score of 8.17 + / - 0.96 cm and 8.30 + / - 0.23 cm respectively to a mean post-spinal pain score of 0.23 + / - 0.45 cm and 0.09 + / - 0.47 cm respectively , p = 0.000 .


The mean duration of analgesia in Group B was 61.60 + / - 6.47 mins while it was 128.98 + / - 21.61 mins in Group BF , p = 0.000 .


The study showed that low dose spinal bupivacaine either alone or in combination with fentanyl is safe for labour analgesia , but the combination f bupivacaine with fentanyl provided much more prolonged pain relief


Treatment of women at risk for preterm birth with repeat doses of glucocorticoids reduces neonatal morbidity but could have adverse long-term effects on cardiometabolic health in offspring .


We assessed whether exposure to repeat antenatal betamethasone increased risk factors for later cardiometabolic disease in children whose mothers participated in the Australasian Collaborative Trial of Repeat Doses of Corticosteroids .


Women were randomized to betamethasone or placebo treatment , 7 days after an initial course of glucocorticoids , repeated each week that they remained at risk for preterm birth at < 32 weeks ' gestation .


In this follow-up study , children were assessed at 6 to 8 years ' corrected age for body composition , insulin sensitivity , ambulatory blood pressure , and renal function .


Of 320 eligible childhood survivors , 258 were studied ( 81 % ; 123 repeat betamethasone group ; 135 placebo [ single course ] group ) .


Children exposed to repeat antenatal betamethasone and those exposed to placebo had similar total fat mass ( geometric mean ratio 0.98 , 95 % confidence interval [ CI ] 0.78 to 1.23 ) , minimal model insulin sensitivity ( geometric mean ratio 0.89 , 95 % CI 0.74 to 1.08 ) , 24-hour ambulatory blood pressure ( mean difference systolic 0 mm Hg , 95 % CI -2 to 2 ; diastolic 0 mm Hg , 95 % CI -1 to 1 ) , and estimated glomerular filtration rate ( mean difference 1.2 mL/min/1 .73 m ( 2 ) , 95 % CI -3.2 to 5.6 ) .


Exposure to repeat doses of antenatal betamethasone compared with a single course of glucocorticoids does not increase risk factors for cardiometabolic disease at early school age .


The impact of Hatha yoga as add-on treatment to quetiapine fumarate extended release ( QXR ) or escitalopram ( ESC ) in depressed patients on hypothalamic-pituitary-adrenal ( HPA ) axis activity was assessed .


60 inpatients suffering from major depressive disorder ( MDD ) according to DSM-IV were randomized for a 5 week treatment with Yoga or not ( control group ) and with either QXR ( 300mg/day ) or ESC ( 10mg/day ) .


Serial dexamethasone/corticotropin releasing hormone ( DEX/CRH ) tests were performed to assess HPA axis function .


The Hamilton Depression Rating Scale ( 21-HAMD ) was used weekly .


A more pronounced down regulation of the HPA axis activity due to yoga could not be detected .


The stepwise long term cortisol reduction was seen in both medication groups , irrespectively of yoga add-on treatment .


In addition , cortisol improvers in week 1 of therapy ( reduction in cortisol peak value within the DEX/CRH test ) reached significant greater amelioration of depressive symptoms after 5 weeks .


Our results suggest that antidepressant agents down regulate HPA axis function to a greater extent than additional Hatha yoga treatment .


Moreover , an early reduction of HPA system hyperactivity after one week of pharmacological treatment seems to raise the possibility of a favorable treatment response .


Difficult patients comprise at least 15 % of ambulatory visits and are associated with clinician burnout .


No structured procedure has been reported to assist health care practitioners with these challenging relationships .


This randomized trial evaluated whether a pre - and postvisit patient-centered and clinician-reflective technique called BREATHE OUT improved clinician satisfaction during visits with patients perceived by the clinician as difficult .


Six family medicine residency clinics paired as urban , suburban , and rural sites were randomized by clinic to the BREATHE OUT intervention or usual care of difficult patients .


A total of 57 physician faculty , nurse practitioners , physician assistants , and residents participated .


The validated Physician Satisfaction Scale ( PSS ) was administered and analyzed using hierarchical linear modeling to assess differences between the intervention and control groups .


The BREATHE OUT intervention improved the PSS score ( P = .02 ) in the intervention group compared with the usual care group .


Female practitioners reported worse PSS scores compared with their male counterparts despite whether they used BREATHE OUT ( P = .009 ) .


Application of the BREATHE OUT questionnaire before and after visits improved clinician satisfaction with difficult patient encounters .


Helicobacter pylori infection is a common chronic human bacterial infection .


Triple - therapy regimen containing a proton pump inhibitor , clarithromycin , and either amoxicillin or metronidazole is commonly used as first-line treatment for its eradication .


However , it may not provide the acceptable eradication rate .


The present study was designed to evaluated efficacy of low dose furazolidone with amoxicillin and omeprazole for eradication of H - pylori .


One hundred twenty patients with non - ulcer dyspepsia or peptic ulcer confirmed by upper GI endoscopy , plus H - pylori infection confirmed by rapid urease test were included in the study .


They were randomly divided into two groups , and then received clarithromycin , amoxicillin , and omeprazole , or furazolidone ( 100 mg PO bid ) , amoxicillin , and omeprazole .


They were evaluated using urea breath test at the end of the study .


The eradication rates were 57.6 % and 78.8 % in clarithromycin and furazolidone groups , respectively .


Their difference was statistically significant ( P value 0.013 ) .


No side effect was seen in the furazolidone group .


Low dose furazolidone rather than clarithromycin can be used as low - cost and effective drug for eradication of H - pylori , in combination with amoxicillin and omeprazole .


We examined the effect of a 12-week family-based cognitive behavioural weight management programme developed for use in primary care settings .


The sample consisted of 49 children with obesity ( aged 7-13 years ; mean SD : 10.68 1.24 ) .


Families were randomly assigned to immediate start-up of treatment or to a 12-week waiting list condition .


Outcome measures were body mass index standard deviation score ( BMI SDS ) , self-esteem , symptoms of depression and blood parameters indicative of cardio-metabolic risk .


Assessments were conducted at baseline , post-treatment , post-waiting list and 12 months after treatment termination .


The mean reduction for the treatment group was -0.16 BMI SDS units compared with an increase of 0.04 units for the waiting list group ( p = .001 ) .


For the entire sample , there was a significant post-treatment improvement on BMI SDS ( p = .001 ) , all self-esteem measures ( p = .001 -.041 ) and symptoms of depression ( p = .004 ) .


The mean BMI SDS reduction was -0.18 units post-treatment , and it was maintained at 12-month follow-up .


Significant reductions were found in blood lipid levels of total cholesterol ( p = .03 ) , LDL-cholesterol ( p = .005 ) and HDL-cholesterol ( p = .01 ) at 12-month follow-up .


The favourable effect on most of the psychological measures waned from post-treatment to follow-up , but not approaching baseline levels .


Boys demonstrated significantly greater reductions in BMI SDS than girls ( p = .001 ) , while baseline psychiatric co-morbidity did not influence BMI SDS outcome .


The treatment shows significant and favourable effects on BMI SDS , self-esteem and symptoms of depression compared with a waiting list condition .


To determine , at 6 weeks postsurgery , if a monitored home exercise program ( HEP ) is not inferior to usual care rehabilitation for patients undergoing primary unilateral total knee replacement ( TKR ) surgery for osteoarthritis .


We conducted a multicenter , randomized clinical trial .


Patients ages 45-75 years were allocated at the time of hospital discharge to usual care rehabilitation ( n = 196 ) or the HEP ( n = 194 ) .


Outcomes assessed 6 weeks after surgery included the Western Ontario and McMaster Universities Osteoarthritis Index pain and physical function subscales , knee range of motion , and the 50-foot walk time .


The upper bound of the 95 % confidence interval ( 95 % CI ) mean difference favoring usual care was used to determine noninferiority .


At 6 weeks after surgery there were no significant differences between usual care and HEP , respectively , for pain ( 7.4 and 7.2 ; 95 % CI mean difference [ MD ] -0.7 , 0.9 ) , physical function ( 22.5 and 22.4 ; 95 % CI MD -2.5 , 2.6 ) , knee flexion ( 96 and 97 ; 95 % CI MD -4 , 2 ) , knee extension ( -7 and -6 ; 95 % CI MD -2 , 1 ) , or the 50-foot walk time ( 12.9 and 12.9 seconds ; 95 % CI MD -0.8 , 0.7 seconds ) .


At 6 weeks , 18 patients ( 9 % ) allocated to usual care and 11 ( 6 % ) to the HEP did not achieve 80 knee flexion .


There was no difference between the treatment allocations in the number of hospital readmissions .


The HEP was not inferior to usual care as an early rehabilitation protocol after primary TKR .


To evaluate muscle fatigue and participant pain in the upper back , cervical , and arm muscles associated with microlaryngeal surgery ( MLS ) in standardized favorable and unfavorable ergonomic positions .


Individual randomized counterbalanced design .


Electromyographic sensors were placed on targeted muscles involved with performing MLS on 18 otolaryngology residents/fellows .


Subjects were randomly counterbalanced in both favorable and unfavorable positions while completing simulated laryngeal microsurgical tasks .


Participants reported their extent of muscle discomfort in targeted muscle regions on a standardized survey .


Muscle fatigue and self-reported pain were reduced , and productivity was improved in the favorable position .


In the lower trapezius , significantly less muscle activation ( P = 0.025 ) and less pain ( P < 0.05 ) were found while in the favorable position compared to the unfavorable position .


This is the first study to demonstrate electromyographic evidence of decreased muscle activation and fatigue , in addition to self-reported pain with a more favorable microsurgical ergonomic position , which may help surgeons avoid musculoskeletal injuries .


To determine if functional discharge readiness and mobility following total knee arthroplasty ( TKA ) for osteoarthritis is delayed after femoral nerve block ( FNB ) with or without patient-controlled analgesia ( PCA ) opioid compared with PCA opioid alone .


We analyzed secondary outcomes from a randomized controlled trial with 200 patients undergoing unilateral TKA .


Experimental group 1 received single-injection FNB with intravenous PCA opioid , experimental group 2 received continuous FNB , and the control group received PCA opioid alone .


FNB was administered using bupivacaine .


Patients followed a structured TKA pathway .


Discharge readiness outcomes included achievement of 90 knee flexion , independent walking , and stair climbing , and were assessed daily before discharge or day 6 , whichever came first .


Mobility outcomes included the Timed Up and Go ( TUG ) test , the 6-Minute Walk Distance ( 6MWD ) , and self-reported physical function , and were assessed at weeks 2 and 12 .


TUG was also assessed on days 3 to 6 , postoperation .


Both FNB groups ( 77 % ) were more likely to achieve 90 knee flexion compared with the control group ( 59 % ) ; odds ratio ( OR ) 2.3 , 95 % confidence interval ( 95 % CI ) 1.1 , 4.8 for single-injection FNB , and OR 2.3 , 95 % CI 1.1 , 4.9 for continuous FNB .


There were no significant differences in independent walking and stair-climbing ability before discharge , TUG , 6MWD , or self-reported physical function , between the FNB groups compared with the control group .


After TKA , FNB ( single-injection with PCA opioid or continuous ) does not delay achievement of 90 knee flexion or other measures of functional discharge readiness and mobility compared with PCA opioid alone .


In preterm infants receiving supplemental oxygen , routine manual control ( RMC ) of the fraction of inspired oxygen ( FIO2 ) is often difficult and time consuming .


We developed a system for closed-loop automatic control ( CLAC ) of the FIO2 and demonstrated its short-term safety and efficacy in a single-center study .


The objective of this study was to test the hypothesis that this system is more effective than RMC alone in maintaining arterial oxygen saturation within target levels when evaluated over 24 hours under routine conditions and with different target levels .


We performed a multicenter , randomized controlled , crossover clinical trial in 34 preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure and supplemental oxygen .


Twenty-four-hour periods with RMC were compared with 24-hour periods of RMC supported by CLAC .


The median ( range ) percentage of time with arterial oxygen saturation levels within target range was 61.4 ( 31.5-99 .5 ) for RMC and 71.2 ( 44.0-95 .4 ) for CLAC ( P < .001 ) .


The median ( range ) number of manual FIO2 adjustments was reduced from 77.0 ( 0.0-224 .0 ) for RMC to 52.0 ( 10.0-317 .0 ) for CLAC ( P = .007 ) .


CLAC may improve oxygen administration to preterm infants receiving mechanical ventilation or nasal continuous positive airway pressure while reducing workload related to RMC .


Dacomitinib is an irreversible pan-EGFR family tyrosine kinase inhibitor .


Findings from a phase 2 study in non-small cell lung cancer showed favourable efficacy for dacomitinib compared with erlotinib .


We aimed to compare dacomitinib with erlotinib in a phase 3 study .


In a randomised , multicentre , double-blind phase 3 trial in 134 centres in 23 countries , we enrolled patients who had locally advanced or metastatic non-small-cell lung cancer , progression after one or two previous regimens of chemotherapy , Eastern Cooperative Oncology Group ( ECOG ) performance status of 0-2 , and presence of measurable disease .


We randomly assigned patients in a 1:1 ratio to dacomitinib ( 45 mg/day ) or erlotinib ( 150 mg/day ) with matching placebo .


Treatment allocation was masked to the investigator , patient , and study funder .


Randomisation was stratified by histology ( adenocarcinoma vs non-adenocarcinoma ) , ethnic origin ( Asian vs non-Asian and Indian sub-continent ) , performance status ( 0-1 vs 2 ) , and smoking status ( never-smoker vs ever-smoker ) .


The coprimary endpoints were progression-free survival per independent review for all randomly assigned patients , and for all randomly assigned patients with KRAS wild-type tumours .


The study has completed accrual and is registered with ClinicalTrials.gov , number NCT01360554 .


Between June 22 , 2011 , and March 12 , 2013 , we enrolled 878 patients and randomly assigned 439 to dacomitinib ( 256 KRAS wild type ) and 439 ( 263 KRAS wild type ) to erlotinib .


Median progression-free survival was 26 months ( 95 % CI 19-28 ) in both the dacomitinib group and the erlotinib group ( stratified hazard ratio [ HR ] 0941 , 95 % CI 0802-1104 , one-sided log-rank p = 0229 ) .


For patients with wild-type KRAS , median progression-free survival was 26 months for dacomitinib ( 95 % CI 19-29 ) and erlotinib ( 95 % CI 19-30 ; stratified HR 1022 , 95 % CI 0834-1253 , one-sided p = 0587 ) .


In patients who received at least one dose of study drug , the most frequent grade 3-4 adverse events were diarrhoea ( 47 [ 11 % ] patients in the dacomitinib group vs ten [ 2 % ] patients in the erlotinib group ) , rash ( 29 [ 7 % ] vs 12 [ 3 % ] ) , and stomatitis ( 15 [ 3 % ] vs two [ < 1 % ] ) .


Serious adverse events were reported in 52 ( 12 % ) patients receiving dacomitinib and 40 ( 9 % ) patients receiving erlotinib .


Irreversible EGFR inhibition with dacomitinib was not superior to erlotinib in an unselected patient population with advanced non-small-cell lung cancer or in patients with KRAS wild-type tumours .


Further study of irreversible EGFR inhibitors should be restricted to patients with activating EGFR mutations .


Pfizer .


The aim of this study is to assess efficacy and safety of reinforced H. pylori eradication therapy .


During 2013-2014 , 40 outpatients were examined .


The study included men and women 18-65 y.o.


They have been devided in to 2 group by randomized choice ( 20 patients in each group ) .


Patients were treated with the reinforced H. pylori eradication therapy : PPI ( 40 mg , / q12h ) , clarithromycin ( 500mg/q12h ) , amoxicillin ( 1000 mg/q12h ) , bismuth subcitrate ( 240 mg/q12h ) for 10 days .


The first group given bismuth subcitrate -- De-Nol , the second group given Novobismol .


Eradication was confirmed by a 13C-urea breath test and monoclonal stool antigen test 6-8 weeks after therapy .


A total of 34 patients underwent eradication treatment .


Two were lost to follow-up ( one patient in each group ) , four patients ( two patients in each group ) did not complete treatment due to adverse events .


The eradication rates were 97.1 % ( 95 % CI , 88.9 % -100.0 % ) by per-protocol ( PP ) and 82.5 % ( 95 % CI , 69.4 % - 92.5 % ) by intention-to-treat ( ITT ) in the two groups .


The ITT analyses resulted in rates of 85 % ( 95 % CI , 66.5-96 .9 ) for the 10-d reinforced therapy with DeNol and was 80 % ( 95 % CI : 60.2-94 .1 ) for the 10-d reinforced therapy with Novobismol ( P = 0.68 ) , while the PP analyses resulted in 100 % ( 95 % CI , 94.5-100 .0 ) and 94.1 % ( 95 % CI : 78.3-99 .9 ) , respectively ( P = 0.31 ) .


The reinforced H. pylori eradication therapy ( 10-day high-dose PPI bismuth-containing standard triple therapy ) achieves a significantly high eradication rates in patients with H. pylori - associated diseases .


Both drugs ( De - Nol and Novobismol ) are both effective and safe for the first-line eradication of H. pylori .


Emergency department discharge instructions are variably understood by patients , and in the setting of emergency department crowding , innovations are needed to counteract shortened interaction times with the physician .


We evaluated the effect of viewing an online video of diagnosis-specific discharge instructions on patient comprehension and recall of instructions .


In this prospective , single-center , randomized controlled trial conducted between November 2011 and January 2012 , we randomized emergency department patients who were discharged with one of 38 diagnoses to either view ( after they left the emergency department ) a vetted online video of diagnosis-specific discharge instructions , or to usual care .


Patients were subsequently contacted by telephone and asked three standardized questions about their discharge instructions ; one point was awarded for each correct answer .


Using an intention-to-treat analysis , differences between groups were assessed using univariate testing , and with logistic regression that accounted for clustering on managing physician .


A secondary outcome measure was patient satisfaction with the videos , on a 10-point scale .


Among 133 patients enrolled , mean age was 46.1 ( s.d.D. 21.5 ) and 55 % were female .


Patients in the video group had 19 % higher mean scores ( 2.5 , s.d. 0.7 ) than patients in the control group ( 2.1 , s.d. 0.8 ) ( p = 0.002 ) .


After adjustment for patient age , sex , first language , triage acuity score , and clustering , the odds of achieving a fully correct score ( 3 out of 3 ) were 3.5 ( 95 % CI , 1.7 to 7.2 ) times higher in the video group , compared to the control group .


Among those who viewed the videos , median rating of the videos was 10 ( IQR 8 to 10 ) .


In this single-center trial , patients who viewed an online video of their discharge instructions scored higher on their understanding of key concepts around their diagnosis and subsequent care .


Those who viewed the videos found them to be a helpful addition to standard care .


ClinicalTrials.gov NCT01361932 http://clinicaltrials.gov/ct2/show/NCT01361932?term=nct01361932&rank=1 .


Anesthesiologists have encountered various difficulties in securing the airway .


Therefore , we compare the intubation times and hemodynamic changes between the McGrath Series 5 video laryngoscope and the Macintosh laryngoscope .


A total of 80 obstetric patients were divided into 2 groups , orotracheally intubated with either the McGrath video laryngoscope or the Macintosh laryngoscope .


The intubation times , Cormack-Lehane grade , percentage of glottic opening , mean arterial blood pressure , and heart rates were compared among the groups .


Intubation time in the McGrath video laryngoscope group was significantly longer than in the Macintosh laryngoscope group ( P < 0.01 ) .


The percentage of glottic opening was found to be higher in the McGrath video laryngoscope group ( P = 0.002 ) .


The McGrath Series 5 video laryngoscope provides excellent views during orotracheal intubation in obstetric anesthesia with normal airways .


Smoking-related cues can trigger drug-seeking behaviors , and computer-based interventions that reduce cognitive biases towards such cues may be efficacious and cost-effective cessation aids .


In order to optimize such interventions , there needs to be better understanding of the mechanisms underlying the effects of cognitive bias modification ( CBM ) .


Here we present a protocol for an investigation of the neural effects of CBM and varenicline in non-quitting daily smokers .


We will recruit 72 daily smokers who report smoking at least 10 manufactured cigarettes or 15 roll-ups per day and who smoke within one hour of waking .


Participants will attend two sessions approximately one week apart .


At the first session participants will be screened for eligibility and randomized to receive either varenicline or a placebo over a seven-day period .


On the final drug-taking day ( day seven ) participants will attend a second session and be further randomized to one of three CBM conditions ( training towards smoking cues , training away from smoking cues , or control training ) .


Participants will then undergo a functional magnetic resonance imaging scan during which they will view smoking-related pictorial cues .


Primary outcome measures are changes in cognitive bias as measured by the visual dot-probe task , and neural responses to smoking-related cues .


Secondary outcome measures will be cognitive bias as measured by a transfer task ( modified Stroop test of smoking-related cognitive bias ) and subjective mood and cigarette craving .


This study will add to the relatively small literature examining the effects of CBM in addictions .


It will address novel questions regarding the neural effects of CBM .


It will also investigate whether varenicline treatment alters neural response to smoking-related cues .


These findings will inform future research that can develop behavioral treatments that target relapse prevention .


Registered with Current Controlled Trials : ISRCTN65690030 .


Registered on 30 January 2014 .


Total hip arthroplasty ( THA ) is an increasingly common treatment for older patients with hip osteoarthritis .


The best strategy for a physiotherapy intervention for older people after THA is not clear in the literature .


The purpose of this protocol study is to test the feasibility of undertaking a full trial clinical to evaluate the effect of ergometer cycling-associated conventional exercises on functional results and health-related quality of life ( HRQOL ) of older patients with THA .


This study protocol is a prospective , single center , randomized controlled pilot clinical trial .


Older patients ( 60 years ) in the postoperative phase after primary unilateral THA for hip osteoarthritis will be consecutively recruited for this study and randomly allocated to 2 treatment groups .


Group I will perform cycle ergometer and conventional exercises , and group II will perform only conventional exercises .


The sessions will be conducted twice a week for 8 weeks .


Assessments will be made at baseline ( 2 weeks postoperatively : the moment that the patients receive a referral for physical therapy , which will start after suture removal ) , after intervention ( 10 weeks postoperatively ) , and at 6 months of follow-up ( 24 weeks postoperatively ) .


The primary outcomes are the function , evaluated using the Harris Hip Score ( HHS ) and the Short Physical Performance Battery ( SPPB ) .


The secondary outcome is HRQOL , measured using 2 evaluation instruments : the Medical Outcomes Study 36-Item Short-Form Health Survey ( SF-36 ) and the Western Ontario and McMaster Universities Osteoarthritis Index ( WOMAC ) .


Data collectors will be blinded and will not have contact with participants during the interventions .


This randomized controlled trial will provide evidence regarding the effect of this exercise therapy on physical function and quality of life in older patients after THA .


If our hypothesis is correct , both interventions will be effective , but the exercises on the cycle ergometer conferring better results in function , physical performance and quality of life .


The study follows Consolidated Standards of Reporting Trials ( CONSORT ) guidelines , and the approval of the local ethics committee has been obtained .


ClinicalTrials.gov : NCT01622465 ( 14 June 2012 ) .


To examine the effects of intravitreal ranibizumab ( Lucentis ; Genentech , Inc. , South San Francisco , CA ) treatment on patient-reported vision-related function , as assessed by 25-item National Eye Institute Visual Function Questionnaire ( NEI VFQ-25 ) scores , in patients with visual impairment secondary to center-involved diabetic macular edema ( DME ) .


Within 2 randomized , double-masked , phase 3 clinical trials ( RIDE [ A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema { ME } With Center Involvement Secondary to Diabetes Mellitus ; NCT00473382 ] and RISE [ A Study of Ranibizumab Injection in Subjects With Clinically Significant Macular Edema { ME } With Center Involvement Secondary to Diabetes Mellitus ; NCT00473330 ] ) , the NEI VFQ-25 was administered at baseline and at the 6 - , 12 - , 18 - , and 24-month follow-up visits .


Three hundred eighty-two ( 100 % ) RIDE patients and 377 ( 100 % ) RISE patients .


Patients were randomized 1:1:1 to monthly injections of intravitreal ranibizumab 0.3 or 0.5 mg or sham .


Study participants could receive macular laser for DME from month 3 onward if specific criteria were met .


Exploratory post hoc analysis of mean change from baseline in NEI VFQ-25 scores at 12 and 24 months .


Across all treatment arms , 13 % to 28 % of enrolled eyes were the better-seeing eye .


For all eyes in RIDE and RISE , the mean change in NEI VFQ-25 composite score improved more in ranibizumab-treated eyes at both the 12 - and 24-month visits compared with sham treatment .


For the better-seeing eyes at baseline , the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 10.9 more ( 95 % confidence interval [ CI ] , 2.5-19 .2 ) than sham for RIDE patients and 1.3 more ( 95 % CI,-10 .5 to 13.0 ) than sham for RISE patients .


For the worse-seeing eyes at baseline , the mean change in composite score with 0.3 mg ranibizumab at the 24-month visit was 1.0 more ( 95 % CI,-4 .7 to 6.7 ) than sham for RIDE patients and 1.8 more ( 95 % CI,-2 .7 to 6.2 ) than sham for RISE patients .


Similar results for most of these outcomes were seen with 0.5 mg ranibizumab .


These phase 3 trials demonstrated that ranibizumab treatment for DME likely improves patient-reported vision-related function outcomes compared with sham , further supporting treatment of DME with ranibizumab .


Robot-aided exercise therapy is a promising approach to enhance walking ability in stroke survivors .


This study was designed to test a new robotic knee brace for restoring mobility in stroke survivors .


Twenty-four ambulatory individuals with chronic hemiparesis after stroke were enrolled in this pilot study .


The participants were randomly assigned in equal numbers to either treatment with the experimental device or to a group exercise program and received a total of 18 hrs of their assigned therapy during a 6-wk training period .


The primary outcome was gait velocity , as measured with the 10-m walk test .


Secondary measures included 6-min walk test , Timed Up and Go test , Five-Times-Sit-to-Stand test , Romberg test , Emory Functional Ambulation Profile , Berg Balance scale , and the California Functional Evaluation 40 .


Twenty subjects completed the entire protocol and all follow-up visits .


No significant differences between the two groups were found for the primary outcome measure at either the completion of training ( week 6 ) or at the 3-mo follow-up ( week 19 ) , with inconsistent findings for secondary measures .


No within-group changes were seen in the primary outcome measure ( 10-m walk test ) in either group .


Within-group improvements were seen in several of the secondary measures for both groups .


No complications of robotic therapy were observed .


Robotic therapy for ambulatory stroke patients with chronic hemiparesis using a robotic knee brace resulted in only modest functional benefits that were comparable with a group exercise intervention .


Apixaban is approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation .


However , the Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation ( ARISTOTLE ) trial included a substantial number of patients with valvular heart disease and only excluded patients with clinically significant mitral stenosis or mechanical prosthetic heart valves .


We compared the effect of apixaban and warfarin on rates of stroke or systemic embolism , major bleeding , and death in patients with and without moderate or severe valvular heart disease using Cox proportional hazards modeling .


Of the 18201 patients enrolled in ARISTOTLE , 4808 ( 26.4 % ) had a history of moderate or severe valvular heart disease or previous valve surgery .


Patients with valvular heart disease had higher rates of stroke or systemic embolism and bleeding than patients without valvular heart disease .


There was no evidence of a differential effect of apixaban over warfarin in patients with and without valvular heart disease in reducing stroke and systemic embolism ( hazard ratio [ HR ] , 0.70 ; 95 % confidence interval [ CI ] , 0.51-0 .97 and HR , 0.84 ; 95 % , CI 0.67-1 .04 ; interaction P = 0.38 ) , causing less major bleeding ( HR , 0.79 ; 95 % CI , 0.61-1 .04 and HR , 0.65 ; 95 % CI , 0.55-0 .77 ; interaction P = 0.23 ) , and reducing mortality ( HR , 1.01 ; 95 % CI , 0.84-1 .22 and HR , 0.84 ; 95 % CI , 0.73-0 .96 ; interaction P = 0.10 ) .


More than a quarter of the patients in ARISTOTLE with nonvalvular atrial fibrillation had moderate or severe valvular heart disease .


There was no evidence of a differential effect of apixaban over warfarin in reducing stroke or systemic embolism , causing less bleeding , and reducing death in patients with and without valvular heart disease .


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


Unique identifier : NCT00412984 .


Prior studies have reported that elevated concentrations of several plasma amino acids ( AA ) , particularly branched chain ( BCAA ) and aromatic AA predict the onset of type 2 diabetes .


We sought to test the hypothesis that circulating BCAA , aromatic AA and related AA metabolites decline in response to the use of insulin sensitizing agents in overweight/obese adults with impaired fasting glucose or untreated diabetes .


We performed a secondary analysis of a randomized , double-blind , placebo , controlled study conducted in twenty five overweight/obese ( BMI ~ 30kg/m ( 2 ) ) adults with impaired fasting glucose or untreated diabetes .


Participants were randomized to three months of pioglitazone ( 45mg per day ) plus metformin ( 1000mg twice per day , N = 12 participants ) or placebo ( N = 13 ) .


We measured insulin sensitivity by the euglycemic-hyperinsulinemic clamp and fasting concentrations of AA and AA metabolites using ultra-pressure liquid chromatography tandem mass spectrometry before and after the three-month intervention .


Insulin sensitizer therapy that significantly enhanced insulin sensitivity reduced 9 out of 33 AA and AA metabolites measured compared to placebo treatment .


Moreover , insulin sensitizer therapy significantly reduced three functionally clustered AA and metabolite pairs : i ) phenylalanine/tyrosine , ii ) citrulline/arginine , and iii ) lysine / - aminoadipic acid .


Reductions in plasma concentrations of several AA and AA metabolites in response to three months of insulin sensitizer therapy support the concept that reduced insulin sensitivity alters AA and AA metabolites .


To compare the clinical efficacy difference in dysantonomia between transcutaneous electrical stimulation at Renying ( ST 9 ) combined with stellate ganglion block ( SGB ) and simple SGB .


Sixty patients in accord with the diagnostic criteria of dysantonomia were randomly divided into two groups ,30 cases in each group .


In the observation group , transcutaneous electrical stimulation at Renying ( ST 9 ) combined with SGB were adopted ; in the control group , simple SGB was applied .


In the two groups , treatment was used three times a week , and nine treatments were considered as one course .


There was an interval of one week between courses , and two courses were treated .


Total seven weeks were required .


Scores were evaluated according to subjective symptoms before treatment , one month and three months after treatment in the two groups .


The scores of subjective symptoms were not statistically different before treatment in the two groups ( P > 0.05 ) .


The scores of subjective symptoms one month and three months after treatment were all lower than those before treatment ( all P < 0.01 ) , and subjective symptoms scores in the observation group were lower than those in the control group ( both P < 0.01 ) .


Transcutaneous electrical stimulation at Renying ( ST 9 ) combined with SGB could obviously enhance the clinical effects for dysantonomia , and the control and improvement for clinical symptoms are apparently superior to simple SGB .


Patients with subocclusive Crohn 's disease ( CD ) who received azathioprine ( AZA ) therapy had lower re-hospitalization rates due to all causes and for surgical management of CD compared to those treated with mesalazine during a 3-year period .


We investigated whether AZA also was effective for prevention of recurrent bowel obstruction .


Rates of recurrent bowel occlusion were compared between patients treated with AZA and those treated with mesalazine .


We assessed the time interval-off intestinal obstruction as well as the occlusion-free survival for both groups .


There was a significantly lower cumulative rate of patients with recurrent subocclusion in the AZA group ( 56 % ) compared with the mesalazine group ( 79 % ; OR 3.34 , 95 % CI 1.67-8 .6 ; P = 0.003 ) , with the number needed to treat in order to prevent 1 subocclusion episode of 3.7 favoring AZA .


The occlusion-free time interval was longer in the AZA group compared with the mesalazine group ( 28.8 vs. 18.3 months ; P = 0.000 ) .


The occlusion-free survival at 12 , 24 , and 36 months was significantly higher in the AZA group ( 91 % , 81 % , and 72 % , respectively ) than in the mesalazine group ( 64.7 % , 35.3 % , and 23.5 % , respectively ; P < 0.05 for all comparisons ) .


In an exploratory analysis of patients with subocclusive ileocecal CD , maintenance therapy with AZA is more effective than mesalazine for eliminating or postponing recurrent intestinal obstruction during 3 years of therapy .


This comparative study was aimed at determining the effectiveness of oral Misoprostol compared with intravenous Ergometrine and intravenous Oxytocin in reducing vaginal bleeding following surgical evacuation for first trimester abortions .


This was a single-blind placebo-controlled study in which patients with first trimester uncomplicated abortions were divided into three groups using computer-generated randomization table .


The first group was administered oral Misoprostol , the second group had intravenous Ergometrine , and the third group was administered intravenous Oxytocin .


The uterotonic agents were administered before the surgical evacuation was carried out .


There was statistically significant reduction in blood loss after the evacuation in the Misoprostol group ( P < 0.000 ) .


There was also significant reduction in the number of days of bleeding in the Misoprostol group ( 2.00 0.86 ) compared with 4.43 0.92 and 4.64 1.06 days in the Ergometrine and Oxytocin groups , respectively ( P < 0.000 ) .


There were , however , more gastrointestinal side effects in the Misoprostol and Ergometrine groups ( 60.7 % and 57.1 % , respectively ) compared with the Oxytocin group .


Oral Misoprostol appeared to demonstrate superior efficacy in reducing uterine bleeding after surgical evacuation , compared to the other commonly used uterotonic agents .


Data on preoperative chemotherapy in resectable oral cavity cancer are conflicting .


We present the long-term results of a randomized trial of induction chemotherapy in resectable oral cavity cancer .


A randomized , parallel , multicentre trial evaluated the impact of three cycles of cisplatin 100 mg/m2 and fluorouracil 1000 mg/m2 ( 120-h infusion administered every 21 days ) in stage T2-T4 , N0-N2 , previously untreated patients with advanced disease .


Control group received upfront surgery .


Postoperative radiation was offered to both arms when pathologic risk features were identified .


The co-primary end points were the occurrence of locoregional or distant tumour relapse , and death .


Among the 198 enrolled patients , with a median follow-up of 11.5 years , there was no difference in the incidence of locoregional relapse between chemotherapy and control group ( P = 0.6337 ) , nor in distant metastasis development ( P = 0.1527 ) .


There was also no difference between groups in overall survival ( P = 0.3402 ) .


Patients with a pathological complete response ( pCR ) had higher probability of survival than those without ( 10-year OS : 76.2 % versus 41.3 % , P = 0.0004 ) .


Late toxicities in patients with a minimum follow-up of 60 months ( 42 in each group ) were similar between arms , except from fibrosis ( cumulative incidence 40 % versus 22 % in chemotherapy arm ) and grade 2 dysphagia ( 14 % versus 5 % ) .


Long-term follow-up of this randomized trial confirmed the absence of survival benefit with preoperative chemotherapy in oral cavity cancer .


Late toxicity was similar in the two arms except for fibrosis and dysphagia , which were less in the chemotherapy arm .


The survival benefit for patients achieving a pCR was maintained .


To evaluate recombinant human luteinizing hormone ( r-hLH ) versus urine-derived human chorionic gonadotropin ( u-hCG ) to trigger ovulation in women ( aged 20-40 years ) with WHO Group II anovulatory infertility undergoing ovulation induction ( OI ) with recombinant human follicle-stimulating hormone ( r-hFSH ) ( 150 IU/day starting dose ) .


For this Phase II , open-label , dose-finding pilot study , patients were randomized to doses of 825 , 2,750 , 5,500 , 11,000 , or 22,000 IU r-hLH or u-hCG ( 5,000 IU ) .


Primary endpoints were ovulation and ratio of ruptured follicles/follicle > or = 15 mm ( day of r-hLH / u-hCG administration ) .


Secondary endpoints included monofollicular ovulation and clinical pregnancy rates .


All 67 randomized patients completed treatment .


All patients in the r-hLH 2,750 ( 13/13 ) , 5,500 ( 12 / 12 ) , 11,000 IU ( 13/13 ) , and u-hCG 5,000 IU ( 12 / 12 ) groups ovulated ; 3/5 patients in the r-hLH 825 IU and 2/12 in the r-hLH 22,000 IU group failed to ovulate ( p = 0.105 between evaluable groups ) .


The mean ratio of ruptured follicles / follicle > or = 15 mm was 1.1 ( p = 0.675 between groups ) .


The monofollicular ovulation rate was 15/60 ( 25 % ) .


Two cases of ovarian hyperstimulation syndrome were reported .


This open-label , pilot study ( conducted in 1999-2001 ) suggests that the minimal effective dose of r-hLH to trigger ovulation in women with WHO Group II anovulatory infertility undergoing OI with r-hFSH ( 150 IU starting dose ) was 2,750 IU .


To compare intraocular pressure ( IOP ) and wound architecture immediately after cataract surgery using a scleral tunnel incision or clear corneal incision .


Prospective randomized clinical trial .


Bilateral eyes of 64 patients undergoing phacoemulsification were randomized to 2 groups : 2.4 mm scleral tunnel incision or 2.4 mm clear corneal incision .


IOP was adjusted upon completion of surgery to between 15 and 30 mm Hg .


The wound was hydrated in 87.5 % of eyes in the clear corneal incision group .


IOP was measured using a rebound tonometer preoperatively ; at the conclusion of surgery ; and at 5 , 10 , 15 , 30 , and 60 minutes postoperatively .


The Seidel test and anterior segment optical coherence tomography ( AS OCT ) were performed at 30 minutes postoperatively .


In the scleral tunnel incision group , mean IOP decreased to the preoperative level within 15 minutes postoperatively and did not change significantly for up to 60 minutes .


In the clear corneal incision group , IOP decreased to lower than the preoperative IOP at 30 minutes postoperatively .


Mean IOP was significantly higher in the scleral tunnel incision group than in the clear corneal incision group throughout the postoperative period ( P. 0339 ) .


Hypotony ( < 10 mm Hg ) was observed in 7 eyes ( 10.9 % ) that underwent clear corneal incision and in no eyes that underwent scleral tunnel incision ( P = .0131 ) .


Wound leakage and loss of wound coaptation were not observed in any eyes .


IOP was significantly higher immediately after scleral tunnel incision without hydration than after clear corneal incision with hydration , and both incisions closed within 30 minutes postoperatively without leakage based on AS OCT. .


To understand clinician adoption of CDS tools as this may provide important insights for the implementation and dissemination of future CDS tools .


Clinicians ( n = 168 ) at a large academic center were randomized into intervention and control arms to assess the impact of strep and pneumonia CDS tools .


Intervention arm data were analyzed to examine provider adoption and clinical workflow .


Electronic health record data were collected on trigger location , the use of each component and whether an antibiotic , other medication or test was ordered .


Frequencies were tabulated and regression analyses were used to determine the association of tool component use and physician orders .


The CDS tool was triggered 586 times over the study period .


Diagnosis was the most frequent workflow trigger of the CDS tool ( 57 % ) as compared to chief complaint ( 30 % ) and diagnosis/antibiotic combinations ( 13 % ) .


Conversely , chief complaint was associated with the highest rate ( 83 % ) of triggers leading to an initiation of the CDS tool ( opening the risk prediction calculator ) .


Similar patterns were noted for initiation of the CDS bundled ordered set and completion of the entire CDS tool pathway .


Completion of risk prediction and bundled order set components were associated with lower rates of antibiotic prescribing ( OR 0.5 ; CI 0.2-1 .2 and OR 0.5 ; CI 0.3-0 .9 , respectively ) .


Different CDS trigger points in the clinician user workflow lead to substantial variation in downstream use of the CDS tool components .


These variations were important as they were associated with significant differences in antibiotic ordering .


These results highlight the importance of workflow integration and flexibility for CDS success .


Patterns of inhaled 2-agonist therapy use during severe asthma exacerbations before hospital attendance are poorly understood .


To assess 2-agonist use prior to hospital attendance .


We undertook an exploratory post hoc analysis of data from a 6-month clinical trial of 303 patients randomised to combination budesonide/formoterol inhaler according to a Single combination inhaler as Maintenance And Reliever Therapy regimen ( ` SMART ' ) or fixed-dose budesonide/formoterol with salbutamol as reliever ( ` Standard ' ) .


Patterns of 2-agonist use for 14 days before hospital attendance with a severe asthma exacerbation were determined by electronic monitoring of inhaler use .


There were 22 hospital attendances in 16 patients during the study .


Seven and nine hospital attendances were eligible for analysis in the SMART and Standard groups , respectively .


In both regimens , 2-agonist use increased before hospital attendance , with a median ( range ) maximum daily number of actuations of 14 ( 9 to 63 ) budesonide/formoterol in SMART and 46 ( 6 to 95 ) salbutamol in Standard with 4 ( 0 to 10 ) budesonide/formoterol actuations on the day of maximal salbutamol use .


There was delay in obtaining medical review despite high 2-agonist use , in 9/16 patients .


Different patterns of use were observed , including repeated days of no inhaled corticosteroid despite marked salbutamol use , which occurred in 3/9 patients in the Standard group .


Delay in obtaining medical review in association with high 2-agonist use is common in patients before hospital presentation with severe exacerbations of asthma .


The SMART regimen reduced nonadherence with inhaled corticosteroid therapy during severe exacerbations .


Hypotension is a common problem during spinal anesthesia for cesarean delivery .


Intravenous fluid loading is used to correct preoperative dehydration and reduce the incidence and severity of hypotension .


Different fluid regimens have been studied but colloid preload and crystalloid co-load have not been compared .


In this randomized double-blind study , 210 patients scheduled for elective cesarean section under spinal anesthesia were randomly allocated to receive either 6 % hydroxyethyl starch 130/0 .4 500 mL before spinal anesthesia ( colloid preload ) or Ringer 's acetate solution 1000 mL administered rapidly starting with intrathecal injection ( crystalloid co-load ) .


Maternal hypotension ( systolic blood pressure < 80 % of baseline or < 90 mmHg ) and severe hypotension ( systolic blood pressure < 80 mmHg ) were treated with 5 and 10mg ephedrine boluses , respectively .


The primary outcome was the incidence of hypotension .


Secondary outcomes included the incidence of severe hypotension , total ephedrine dose , nausea and vomiting and neonatal outcome assessed by Apgar scores and umbilical artery blood gas analysis .


Data analysis was performed on 205 patients ; 103 in the colloid preload group and 102 in the crystalloid co-load group .


There were no significant differences in the incidence of hypotension ( 52.4 % vs. 42.2 % ; P = 0.18 ) or severe hypotension ( 15.5 % vs. 9.8 % ; P = 0.31 ) between colloid preload and crystalloid co-load groups , respectively .


The median [ range ] ephedrine dose was 5 [ 0-45 ] mg in the colloid preload group and 0 [ 0-35 ] mg in the crystalloid co-load group ( P = 0.065 ) .


There were no significant differences in maternal nausea or vomiting or neonatal outcomes between groups .


The use of 1000 mL crystalloid co-load has similar effect to 500 mL colloid preload in reducing the incidence of hypotension after spinal anesthesia for elective cesarean delivery .


Neither technique can totally prevent hypotension and should be combined with vasopressor use .


Insight in the natural course of care dependency of vulnerable older persons in long-term care facilities ( LTCF ) is essential to organize and optimize individual tailored care .


We examined changes in care dependency in LTCF residents over two 6-month periods , explored the possible predictive factors of change and the effect of care dependency on mortality .


A prospective follow-up study in 21 Dutch long-term care facilities .


890 LTCF residents , median age 84 ( Interquartile range 79-88 ) years participated .


At baseline , 6 and 12 months , care dependency was assessed by the nursing staff with the Care Dependency Scale ( CDS ) , range 15-75 points .


Since the median CDS score differed between men and women ( 47.5 vs. 43.0 , P = 0.013 ) , CDS groups ( low , middle and high ) were based on gender-specific 33 % of CDS scores at baseline and 6 months .


At baseline , the CDS groups differed in median length of stay on the ward , urine incontinence and dementia ( all P < 0.001 ) ; participants in the low CDS group stayed longer , had more frequent urine incontinence and more dementia .


They had also the highest mortality rate ( log rank 32.2 ; df = 2 ; P for trend < 0.001 ) .


Per point lower in CDS score , the mortality risk increased with 2 % ( 95 % CI 1 % -3 % ) .


Adjustment for age , gender , cranberry use , LTCF , length of stay , comorbidity and dementia showed similar results .


A one point decrease in CDS score between 0 and 6 months was related to an increased mortality risk of 4 % ( 95 % CI 3 % -6 % ) .


At the 6-month follow-up , 10 % improved to a higher CDS group , 65 % were in the same , and 25 % had deteriorated to a lower CDS group ; a similar pattern emerged at 12-month follow-up .


Gender , age , urine incontinence , dementia , cancer and baseline care dependency status , predicted an increase in care dependency over time .


The majority of residents were stable in their care dependency status over two subsequent 6-month periods .


Highly care dependent residents showed an increased mortality risk .


Awareness of the natural course of care dependency is essential to residents and their formal and informal caregivers when considering therapeutic and end-of-life care options .


The purpose of this study was to assess the influence of axial length on spectral-domain optical coherence tomography ( SD-OCT ) thickness measurements in patients with subretinal visual implants .


Data from eight emmetropic pseudophakic eyes of eight patients with subretinal visual implants were analyzed retrospectively .


These patients participated in the monocentric part of a multicenter trial .


The axial length was measured in three short ( < 22.5 mm ) , three medium ( 22.51-25 .50 mm ) , and two long ( > 25.52 mm ) eyes .


Using Heidelberg Spectralis , the known thickness of a subretinal implant microchip ( 70 m ) was measured on 15 images per eye with SD-OCT , using the software calipers .


The mean axial length was 20.8 0.8 mm in short eyes , 23.3 0.4 mm in medium eyes , and 26.3 0.5 mm in long eyes .


We found in short eyes , in medium eyes , and in long eyes a mean value of microchip thickness measurements from SD-OCT of 82.9 1.4 m , 70.5 1.3 m , and 64.2 1.3 m , respectively .


The thickness measurements decreased in SD-OCT measurements with longer axial lengths significantly ( P < 0.0001 ) .


Axial length influences SD-OCT thickness measurements .


Our findings demonstrate accuracy of the scaling in SD-OCT thickness measurements in emmetropic medium eyes .


Caution is recommended when comparing the measured values of short and long eyes with the normative database of the instrument .


There is a need for larger sample-size studies to confirm our results .


( ClinicalTrials.gov number , NCT01024803 . )


Renal transplantation is the best treatment for kidney failure , in terms of length and quality of life and cost-effectiveness .


However , most transplants fail after 10 to 12 years , consigning patients back onto dialysis .


Damage by the immune system accounts for approximately 50 % of failing transplants and it is possible to identify patients at risk by screening for the presence of antibodies against human leukocyte antigens .