The addition of gallium-aluminum-arsenide laser irradiation to intravenous regional anesthesia is safe , and reduces pain during and after the operation .


Physical activity ( PA ) is not only an important marker of physical impairment , but also a pathway to improve quality of life and enhance cognitive and social functioning of old individuals .


Yet , making interventional use of PA training as a means for prevention and enhancement of quality of life of nursing home residents has found very limited attention worldwide so far .


That said , the project ` Long-term Care in Motion ' ( LTCMo ) as a part of the INNOVAGE consortium ( funded by the European Commission ) has the following aims : Overall : Install and assess a socially innovative intervention in the nursing home ecology .


Concrete : ( a ) Conceptualization of a multidimensional intervention program ( resident and staff oriented ) with the potential to promote PA in nursing home residents ; ( b ) Mixed-methods assessment of the program based on automated recording as well as questionnaire data .


LTCMo 's PA-related intervention has several components which are applied in parallel manner : ( 1 ) Residents are engaged in a physical exercise program that is based on multiple approaches : supervised group sessions , a serious games approach , and specific training in severely impaired persons ; ( 2 ) Staff members will receive a competence training with a focus on PA motivation and facilitation of residents ' PA engagement .


Primary outcome assessment ( movement-related behavior of residents ) is completely conducted by means of automated data collection strategies ( accelerometer-based activity recording , sensor-based life space recording ) .


This is enriched by a broad range of secondary outcomes ( e.g. , cognitive performance , depression of residents ; behavioral and attitudinal components of staff ) .


Pre - , post - and 3-month follow-up assessment will take place in the target intervention setting as well as in a waiting control condition in which we will also replicate the training and its assessment in a later step .


Although we are faced with methodological challenges ( e.g. , rather small sample size ; no randomized control trial ) , we believe that our approach has something to offer and indeed has some unique characteristics that may have the potential to contribute to the enhancement of nursing home residents ' quality of life and at the same time further PA-related research with vulnerable populations at large .


Current Controlled Trials ISRCTN96090441 .


Registered 31 July 2014 .


A prospective , randomized study wias performed to compare two anesthetic methods .


To evaluate the effect of epidural analgesia on postoperative pain , endocrine - metabolic and inflammatory stress response and cellular inmmune responses during major corrective spine surgetry .


The study included 350 patients aged 15 to 65 who were randomly allocated to two equal groups .


Group I ( n = 205 ) had continuous epidural analgesia ( E4 ) and sevoflurane anesthesia during surgety and continuous epidural analgesia with ropivacaine and fentanil after surgery ; Group 2 ( n = 145 ) had general anesthesia with sevoflurane and fentanil and systemic administration of opioids after surgery .


Patient pain , PONV syndrome , mobility , and satisfaction were measured after surgery along with plasma levels ofcortisol , ghmcose , interleukins IL-1 , IL-6 , and IL-10 during and after surgemy C-reactive protein ( CRP ) , and cell-surface receptor expression of immune cells ( cluster of differentiation ) HLA-DR + / CD3 - , HLA-DR + / CD3 + , HILA-DR , CD3 , CD4 , CD8 , CD16 , CD19 CD16/56 + , and CD16/56 + / CD3 + ) were measured perioperatively .


In group 1 , there were significantly less pain , less nausea , earlier mobility , and higher satisfaction than those in group 2 .


Group I has also demonstrated significantly less plasma levels of glucose , cortisol , CRP , IL-l , IL-6 , IL-10 at various stages .


The ratio of CD4/CD8 ( p = 0.001 ) and B cells ( p = 0.01 ) have increased by postoperative day 3 in group 1 .


NK-cells ( CD16/56 + ) have decreased significantly by day 3 after surgery ( p = 0.001 ) compared to the group 2 .


T-lymphocytes , ( CD3 ) have decreased in all patients , but they were significantly lower in patients receiving opioids , compared wiith EA .


Polerfulr afferent stimulation in major corrective spine surgery accompanied by immunosuppression for at least a wieek after surgery .


EA reduces the surgical stress response , prevents postoperative lymphocyte apoptosis and thus , increases stress and infectious resistance .


Central obesity in polycystic ovary syndrome ( PCOS ) is associated with increased inflammatory markers and increased risk for type 2 diabetes .


To evaluate if improved body composition during treatment with metformin ( M ) vs. oral contraceptive pills ( OCP ) was associated with changes in circulating adiponectin , interleukin ( IL ) -6 , and monocyte chemoattractant protein ( MCP ) -1 .


Ninety patients with PCOS were randomized to 12-month treatment with M ( 2 g/day ) , M + OCP ( 150 mg desogestrel + 30 microgram ethinylestradiol ) or OCP .


Adiponectin , IL-6 , MCP-1 , whole body DXA scans , and clinical evaluations were performed before and after the intervention period in the 65 study completers .


Changes in inflammatory markers and changes in total and regional fat mass estimates .


Adiponectin , IL-6 , and MCP-1 levels were unchanged during the three types of medical intervention .


Treatment with M and M + OCP was superior to OCP regarding decreased regional fat mass .


Baseline adiponectin and IL-6 were associated with BMI , waist , and trunk fat mass .


Changes in trunk fat were significantly associated with changes in IL-6 and MCP-1 during M + OCP .


Long-term treatment with M alone or in combination with OCP was associated with improved body composition compared to OCP , whereas inflammatory markers were unchanged .


OCP was not associated with increased inflammatory markers despite a small but significant weight gain .


To compare the effects of bupivacaine , lidocaine and saline injections in alleviating post tonsillectomy pain .


We recruited 60 patients into the study .


All subjects were randomly allocated into 3 groups .


Group 1 received 0.9 % sodium chloride ( saline group ) , group 2 received 0.25 % bupivacaine ( bupivacaine group ) and group 3 received 2 % lidocaine ( lidocaine group ) , infiltrated around each tonsil .


Pain was evaluated with McGrath 's face scale .


The postoperative pain scores at 2 and 6 hours were similar among the groups ( P > 0.05 ) .


The pain scores in the bupivacaine group were lower than those in the saline group at 12 h ( P < 0.05 ) .


The pain scores in the bupivacaine and lidocaine groups were significantly lower than those in the saline group from 18 to 24 hours until day 7 ( P < 0.05 ) .


There was no difference between the bupivacaine and lidocaine groups ( P > 0.05 ) .


Local infiltration of bupivacaine is a relatively and safe effective method and is equivalent to use of lidocaine for post tonsillectomy pain .


The traditional Chinese theory of acupuncture emphasizes that the intensity of acupuncture must reach a threshold to generate de qi ( a specific and compound sensation during the acupuncture ) , which is necessary to achieve the best therapeutic effect .


However , the notion that de qi must be achieved for maximum benefit has not been confirmed by modern scientific evidence .


This study aims to compare the efficacy of acupuncture with either strong ( intended to elicit de qi ) or weak stimulation among patients with allergic rhinitis .


This study compares real versus sham acupuncture in 140 patients with a history of persistent allergic rhinitis ( PER ) or intermittent allergic rhinitis ( IAR ) and with a positive skin prick test ( SPT ) .


The trial will be conducted in the Teaching Hospital of Chengdu University of Traditional Chinese Medicine ( China ) .


In the study , patients will be randomly assigned into two groups by computer-generated randomization and assessed prior to treatment .


They will then receive 12 sessions of treatments for 4 consecutive weeks and have a follow-up phase lasting 12 weeks .


The main outcome measures include the primary and secondary indicators .


Primary indicators are subjective symptoms scores as evaluated by visual analogue scales ( VAS ) , rhinoconjunctivitis quality of life questionnaires ( RQLQ ) , and the Modified Massachusetts General Hospital acupuncture sensation scale , Chinese version ( C-MMASS ) .


The secondary indicators are the results of laboratory examinations , such as serum allergen-specific immunoglobulin E ( sIgE ) nasal inflammatory cells counts ( mast cells , eosinophils , and T cells ) , and nitric oxide concentration in nasal excretion .


The use of anti-allergic medication will also be recorded as one of the secondary indicators .


Furthermore , adverse events will be recorded and analyzed .


Intention-to-treat analysis ( ITT ) and per-protocol ( PP ) analysis will be performed to test and verify the results in this trial .


The results of this trial will demonstrate the efficacy of using acupuncture to treat allergic rhinitis and verify whether the effectiveness of acupuncture is related to the needle sensation de qi .


Chinese Clinical Trial Registry : ChiCTR-TRC-13003594 ( registered on 16 August 2013 , and the first patient was randomized on 27 September 2013 ) .


The two-operator technique for colonoscopy , with the endoscopy assistant actively advancing and withdrawing the scope , is still commonly practiced in Europe .


As uncontrolled data has suggested that the one-operator technique is associated with a higher adenoma detection rate , we tested the hypothesis that the two-operator-technique can achieve comparable performances in terms of adenoma detection .


Non-inferiority trial in which consecutive adult outpatients were randomised to undergo colonoscopy by one ( one-operator ) or by four endoscopists .


Each performed half the procedures by one-operator and half by two-operator technique independently of routine clinical practice .


Main outcome measure was adenoma detection rate .


352 subjects ( 49 % males , mean age 60 12.1 years ) were randomised to one ( n = 176 ) or to two-operator technique ( n = 176 ) colonoscopy .


No significant differences were found in adenoma detection ( 33 % vs. 30.7 % , p = 0.65 ) , or cecal intubation rate , procedure times , and patient tolerability .


No differences were found in the subgroup analysis according to routinely adopted colonoscopy technique .


This study does not confirm a higher adenoma detection rate for one-operator technique colonoscopy .


Changing current practice to improve adenoma detection rate for endoscopists routinely using two-operator technique is not warranted .


The aim of this case-control study was to compare the efficacy of ethinyl estradiol/drospirenone and Fructus agni casti in women with severe primary dysmenorrhea measuring uterine artery blood flow via Doppler ultrasonography .


A total of 60 women with severe primary dysmenorrhea and 30 healthy women ( control ) were included in this study .


Thirty patients were treated with ethinyl estradiol 0.03 mg/drospirenone ( group 1 ) and another 30 were treated with Fructus agni casti ( group 2 ) during three menstrual cycles .


Before and at the end of third month of therapy visual analog scale ( VAS ) scores , pulsatility index ( PI ) , resistance index ( RI ) of uterine artery were recorded before and after receiving therapy on the first day of the menstrual cycle .


Mean PI and RI values in patients with severe primary dysmenorrhea were significantly higher than in the control groups on the first day of the menstrual cycle ( P < 0.0001 ) .


Mean PI and RI values were significantly lower after the treatment in both groups compared to before values ( P < 0.001 for both ) .


After using the drugs for three menstrual cycles , VAS scores were significantly dropped in both groups compared to before treatment values ( P < 0.0001 for both ) ; however , there were no significant differences in terms of Doppler findings between group 1 and 2 .


The effectiveness of Fructus agni casti was similar to that of ethinyl estradiol/drospirenone in patients with primary dysmenorrhea .


Dyspnea and exercise intolerance are the symptoms that most affect the quality of life of children and adolescents with respiratory disorders resulting from cystic fibrosis ( CF ) .


To evaluate the effect of noninvasive ventilation ( NIV ) on treadmill 6-min walk distance and regional chest wall volumes in cystic fibrosis patients .


Crossover clinical trial , randomized , controlled and open with 13 children and adolescents with CF , aged 7-16 years , with pulmonary impairment ( NTC01987271 ) .


The patients performed a treadmill walking test ( TWT ) during 6min , with and without NIV on a BiLEVEL mode , an interval of 24-48hbetween tests .


Before and after each test , patients were assessed by spirometry and optoelectronic plethysmography .


Walking distance in TWT with NIV was significantly higher that without ventilatory support ( meansd : 0.410.08 vs. 0.390.85 km , p = 0.039 ) .


TWT with NIV increase forced expiratory volume on 1s ( FEV1 ; p = 0.036 ) , tidal volume ( Vt ; p = 0.005 ) , minute ventilation ( MV ; p = 0.013 ) , pulmonary rib cage volume ( Vrcp ; p = 0.011 ) , and decrease the abdominal volume ( Vab ; p = 0.013 ) after test .


There was a significant reduction in oxygen saturation ( p = 0.018 ) and permanent increase in respiratory rate after 5min ( p = 0.021 ) after the end test without NIV .


During the walking test on the treadmill , the NIV change thoracoabdominal kinematics and lung function in order to optimized ventilation and tissue oxygenation , with improvement of walk distance .


Consequently , NIV is an effective tool to increase functional capacity in children and adolescents with cystic fibrosis .


This study aimed to compare three-dimensional conformal radiotherapy ( 3D CRT ) and intensity-modulated radiotherapy ( IMRT ) combined with concurrent chemotherapy for cervical cancer .


A total of 72 patients with Grades IIa-IIIb cervical cancer were randomly divided into two groups , namely , the IMRT group for IMRT plan ( primary lesion , 45 Gy/22 ; the pelvic wall lymphatic drainage area , 50 Gy/22 ) , and the 3D CRT group ( conformal pelvic radiotherapy , 45 Gy/22 ; subsequent supplement of pelvic wall , 6.0 Gy/3 ) .


Both groups received concurrent chemotherapy of nedaplatin 30 mg/m2 weekly for six cycles , with an after-loading therapy of 6 Gy/6 each time .


In the IMRT group , the grade III diarrhea rate was 5.6 % and the rate in the 3D CRT group was 30.6 % ; both groups significantly differed .


No significant difference was observed between the overall survival and disease-free survival in first , second , and third years in both groups .


Cervical cancer IMRT can significantly reduce the incidence of acute enteritis .


For standard 3D CRT , no significant difference was observed in overall survival and disease-free survival .


The Helicobacter pylori eradication rate with standard triple therapy is very low .


H. pylori is known to require the nickel-containing metalloenzymes urease and NiFe-hydrogenase to survive at the low pH environment in the stomach .


To compare the H. pylori eradication rate of a nickel free-diet associated with standard triple therapy and standard triple therapy alone as the first-line regimen .


Fifty-two sex - and age-matched patients at the first diagnosis of H. pylori infection were randomized 1:1 into two different therapeutic schemes : ( 1 ) standard LCA ( 26 patients ) : lansoprazole 15 mg bid , clarithromycin 500 mg bid and amoxicillin 1,000 mg bid for 7 days with a common diet ; ( 2 ) standard LCA plus a nickel free-diet ( NFD-LCA ) ( 26 patients ) .


Patients followed 30 days of a nickel-free diet plus a week of lansoprazole 15 mg bid , clarithromycin 500 mg bid and amoxicillin 1,000 mg bid starting from day 15 of the diet .


All patients completed the study .


A significantly higher eradication rate was observed in the NFD-LCA group ( 22/26 ) versus LCA group ( 12/26 ) ( p < 0.01 ) .


Only a few patients ( 9 of 52 ) reported the occurrence of mild therapy-related side effects , without any significant differences between the two groups .


The addition of a nickel-free diet to standard triple therapy significantly increases the H. pylori eradication rate .


The reduction of H. pylori urease activity due to the nickel-free diet could expose the bacterium to gastric acid and increase H. pylori 's susceptibility to amoxicillin .


Further studies are necessary to confirm this preliminary result .


The majority of adults are not meeting the guidelines for physical activity despite activity being linked with numerous improvements to long-term health .


In light of this , researchers have called for more community-level interventions .


The main objective of the present study was to evaluate whether a community-level physical activity intervention increased the activity levels of rural communities .


128 rural villages ( clusters ) were randomised to receive the intervention in one of four time periods between April 2011 and December 2012 .


The Devon Active Villages intervention provided villages with 12 weeks of physical activity opportunities for all age groups , including at least three different types of activities per village .


Each village received an individually tailored intervention , incorporating a local needs-led approach .


Support was provided for a further 12 months following the intervention .


The evaluation study used a stepped wedge cluster randomised controlled trial design .


All 128 villages were measured at each of five data collection periods using a postal survey .


The primary outcome of interest was the proportion of adults reporting sufficient physical activity to meet internationally recognised guidelines .


Minutes spent in moderate-and-vigorous activity per week was analysed as a secondary outcome .


To compare between intervention and control modes , random effects linear regression and marginal logistic regression models were implemented for continuous and binary outcomes respectively .


10,412 adults ( 4693 intervention , 5719 control ) completed the postal survey ( response rate 32.2 % ) .


The intervention did not increase the odds of adults meeting the physical activity guideline ( adjusted OR 1.02 , 95 % CI : 0.88 to 1.17 ; P = 0.80 ) , although there was weak evidence of an increase in minutes of moderate-and-vigorous-intensity activity per week ( adjusted mean difference = 171 , 95 % CI : -16 to 358 ; P = 0.07 ) .


The ineffectiveness of the intervention may have been due to its low penetration-only 16 % of intervention mode participants reported awareness of the intervention and just 4 % reported participating in intervention events .


A community-level physical activity intervention providing tailored physical activity opportunities to rural villages did not improve physical activity levels in adults .


Greater penetration of such interventions must be achieved if they are to increase physical activity prevalence at the community level .


Current Controlled Trials ISRCTN37321160 .


Patients with a recent myocardial infarction ( MI ) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption ( Vo2 peak ) .


The impact of a Tai Chi Chuan ( TCC ) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed .


Our goal is to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent MI .


A single-blind randomized clinical trial was conducted .


The researchers who performed the tests were blinded to group allocation .


Between the 14th and 21st days after hospital discharge , all patients performed a cardiopulmonary exercise testing and a laboratory blood workup .


Mean age was similar ( 569 years in the TCC group and 609 years in the control group ) .


Patients allocated to the intervention group performed 3 weekly sessions of TCC Beijin style for 12 weeks ( n = 31 ) .


The control group participated in 3 weekly sessions of full-body stretching exercises ( n = 30 ) .


After the 12-week study period , participants in the TCC group experienced a significant 14 % increase in Vo2 peak from baseline ( 21.6 5.2 to 24.6 5.2 mL/kg per minute ) , whereas control participants had a nonsignificant 5 % decline in Vo2 peak ( 20.4 5.1 to 19.4 4.4 mL/kg per minute ) .


There was a significant difference between the 2 groups ( P < .0001 ) .


Tai Chi Chuan practice was associated with an increase in Vo2 peak in patients with a recent MI and may constitute an effective form of cardiac rehabilitation in this patient population .


To evaluate the in vitro and in vivo effects of three treatment regimens on dentin permeability and reduction of dentin hypersensitivity ( DH ) .


The desensitization treatments were : Gluma Desensitizer PowerGel ( GLU ) , MS Coat One ( MSC ) , and dentin burnishing with fiber-resin burs ( STB ) .


A split-chamber device was used to determine the permeability of dentin slices cut from human molars in vitro .


Fluid flow through dentin was recorded with a photochemical method after EDTA cleaning , albumin soaking and desensitization treatment ( n = 10 ) .


61 study participants with three severely hypersensitive teeth each were enrolled .


Sensitivity was determined with an air stimulus before , immediately after treatment , and after 1 , 3 and 6 months , using a verbal rating scale .


From the 61 study participants enrolled , 52 completed the trial .


Permeability at baseline and after albumin soaking was not significantly different .


All treatments produced reduced fluid flow through dentin ( P > 0.05 ) .


All treatments reduced DH significantly ( no or moderate sensitivity ) .


Statistical results revealed significant differences among the treatments ( P = 0.03 ) .


Mann-Whitney comparisons showed GLU , STB < MSC .


Isotretinoin has been frequently used for acne therapy .


However , it has limitation in acceptance because of its adverse effects .


Although antihistamine recently revealed to decrease the lipogenesis , evidence is lacking regarding the clinical relevance of antihistamine in the treatment of acne .


To evaluate the clinical efficacy and tolerability of antihistamine as an adjuvant treatment of isotretinoin .


Forty patients with moderate acne were included in this randomized , controlled comparative study .


Twenty patients were treated with isotretinoin and 20 patients were treated with additional antihistamine , desloratadine .


Assessment was made at baseline , after 2 , 4 , 8 and 12 weeks of treatment .


At week 12 , compared with isotretinoin only group , isotretinoin with additional antihistamine group showed more statistically significant decrease in acne lesion counts ( non-inflammatory lesions : 44.8 % vs. 17.8 % ; inflammatory lesions : 55.8 % vs. 22.9 % ; total lesions : 45.6 % vs. 18.7 % ; all P < 0.05 ) .


Significant decrease was also observed in the score of global acne grading system and the measured value of sebum and erythema .


Moreover , acne flare during the treatment occurred less frequently and adverse events of isotretinoin were more tolerable in additional antihistamine group .


This results provide early evidence that antihistamine has a synergic effect with minimizing the side-effect of isotretinoin , and may be used as an adjuvant treatment of moderate acne .


Ospemifene is a new oral estrogen receptor agonist/antagonist with tissue-selective effects approved for the treatment of moderate to severe dyspareunia , a symptom of postmenopausal vulvar and vaginal atrophy ( VVA ) .


The aim of the study is to assess ospemifene or lubricant use on the clinical signs of VVA .


Subjects in three double-blind , placebo-controlled clinical trials were randomized to ospemifene or placebo .


In two of the trials , women were provided nonhormonal lubricants for use as needed , and a preplanned evaluation of the frequency of lubricant use was performed .


Additionally , a post hoc placebo group analysis for impact of lubricant use or nonuse on physiologic effects of the percentage of superficial and parabasal cells ( maturation index ) and vaginal pH was conducted .


A secondary preplanned end point included visual examination of the vagina ( clinical signs of vaginal dryness , petechiae , pallor , friability , and redness of the mucosa ) comparing change from baseline to end of treatment for the ospemifene 60-mg/day group and vs. placebo .


The primary end points in the phase 3 clinical trials included the percentage of superficial cells , parabasal cells , vaginal pH , and most bothersome symptoms compared with placebo .


There was no significant difference in physiologic effects between placebo lubricant users vs. nonusers in either 12-week study .


Compared with baseline , substantially more subjects receiving ospemifene 60mg/day than placebo showed complete resolution of clinical signs of VVA after 12 and 52 weeks of treatment .


Ospemifene substantially improved clinical signs of VVA .


Within the placebo group , there was no difference in physiologic effects in lubricant users vs. nonusers .


Based on gynecologic evaluation of the vagina , benefits were apparent at 12 weeks and sustained for 52 weeks in the ospemifene-treated subjects with significant improvement over placebo .


In these three clinical trials , in contrast to ospemifene-treated women , placebo subjects who utilized lubricants had no improvement in their underlying vaginal physiology .


BCG vaccination prevents disseminated tuberculosis in children , but it is contraindicated for persons with human immunodeficiency virus ( HIV ) infection because it can result in severe disease in this population .


In tuberculosis-endemic regions , BCG vaccine is administered soon after birth , before in utero and peripartum HIV infection is excluded .


We therefore assessed the immunogenicity of BCG vaccine in HIV-exposed infants who received BCG at birth or at 8 weeks of age .


HIV-exposed , uninfected infants were randomly assigned to receive BCG vaccination at birth ( the early vaccination arm ) or 8 weeks of age ( the delayed vaccination arm ) .


BCG-specific proliferative and intracellular cytokine responses were assessed in 28 infants per arm at 6 , 8 , and 14 weeks of life .


There was no difference in BCG-specific T-cell proliferation between the study arms 6 weeks after vaccination .


However , at 14 weeks of age , the frequency of interferon - expressing CD4 ( + ) T cells and multifunctional BCG-specific responses in the delayed vaccinated arm were significantly higher than those in the early vaccination arm ( P = .021 and P = .011 , respectively ) .


The immunogenicity of BCG vaccination in HIV-exposed , uninfected infants is not compromised when delayed until 8 weeks of age and results in robust BCG-specific T-cell responses at 14 weeks of age .


These findings support further evaluation of this modified BCG vaccination strategy for HIV-exposed infants .


NCT02062580 .


To characterize the association between clinical symptoms and anatomical and functional cerebral deficits in codeine-containing cough syrups ( CCS ) users using voxel-based morphometry and resting state functional connectivity analysis .


Participants were 30 CCS users and 30 matched controls .


Both groups were scanned using a volumetric three-dimensional fast field echo sequence and a gradient-echo echo-planar imaging sequence .


Impulsivity traits of both groups were evaluated with the Barratt Impulsiveness Scale 11 ( BIS 11 ) .


Voxel-based morphometry was used to characterize gray matter ( GM ) deficits in CCS users .


The clinical significance of regional volume reduction was investigated by evaluating its association with impulsivity in CCS users and with alterations in resting state functional connectivity when brain regions with GM volume reduction were used as seed areas .


Significantly decreased GM volume was observed in CCS users in bilateral ventral medial prefrontal cortex ( vmPFC ) which was related to greater impulsivity in CCS users .


Significantly decreased integration was found in CCS users between the vmPFC and the default mode network .


Also , significantly enhanced functional connectivity was found between the vmPFC and the right insula , and the right dorsal lateral PFC. Negative correlation was observed between BIS total scores , scores for attentional impulsivity and vmPFC-inferior parietal lobe connectivity in CCS users .


The findings revealed volume loss and aberrant functional organization in vmPFC among CCS users .


In addition , the decreased vmPFC GM volume and attenuated functional connectivity of the vmPFC-inferior parietal lobe network were associated with clinical higher impulsivity trait in CCS users .


To observe the differences in the clinical efficacy on menopausal irritability between acupuncture and medication .


Sixty cases of menopausal irritability were randomized into an acupuncture group ( 31 cases ) and a medication group ( 29 cases ) .


In the acupuncture group , the warming needling manipulation was applied at the key acupoints such as Hegu ( LI 4 ) and Taichong ( LR 3 ) , once a day , 10 treatments made one session .


Totally , 2 sessions were required .


In the medication group , 2.5 mg diazepam tablets were prescribed , three times a day , for 23 days totally .


The clinical efficacy , the modified Kupperman score and self-rated health measurement scale ( SRHMS ) were compared before and after treatment in the two groups .


RESULTS The total effective rate was 87.1 % ( 27/31 ) in the acupuncture group and 82.8 % ( 24/29 ) in the medication group .


The difference in the clinical efficacy was not significant between the two groups ( P > 0.05 ) .


The modified Kupperman score and SRHMS score were both reduced obviously after treatment in the two groups , indicating the significant difference ( all P < 0.05 ) .


The reduction of two scores in the acupuncture group was more obvious than those in the medication group ( Kupperman : 15.23 + / - 6.19 vs 18.45 + / - 5.37 ; SRHMS : 116.29 + / - 38.24 vs 140.34 + / - 42.15 , both P < 0.05 ) .


The acupuncture and medication are effective in the treatment of menopausal irritability , but the efficacy of warming needling manipulation is better than that of diazepam tablets .


Edoxaban is a direct oral factor Xa inhibitor with proven antithrombotic effects .


The long-term efficacy and safety of edoxaban as compared with warfarin in patients with atrial fibrillation is not known .


We conducted a randomized , double-blind , double-dummy trial comparing two once-daily regimens of edoxaban with warfarin in 21,105 patients with moderate-to-high-risk atrial fibrillation ( median follow-up , 2.8 years ) .


The primary efficacy end point was stroke or systemic embolism .


Each edoxaban regimen was tested for noninferiority to warfarin during the treatment period .


The principal safety end point was major bleeding .


The annualized rate of the primary end point during treatment was 1.50 % with warfarin ( median time in the therapeutic range , 68.4 % ) , as compared with 1.18 % with high-dose edoxaban ( hazard ratio , 0.79 ; 97.5 % confidence interval [ CI ] , 0.63 to 0.99 ; P < 0.001 for noninferiority ) and 1.61 % with low-dose edoxaban ( hazard ratio , 1.07 ; 97.5 % CI , 0.87 to 1.31 ; P = 0.005 for noninferiority ) .


In the intention-to-treat analysis , there was a trend favoring high-dose edoxaban versus warfarin ( hazard ratio , 0.87 ; 97.5 % CI , 0.73 to 1.04 ; P = 0.08 ) and an unfavorable trend with low-dose edoxaban versus warfarin ( hazard ratio , 1.13 ; 97.5 % CI , 0.96 to 1.34 ; P = 0.10 ) .


The annualized rate of major bleeding was 3.43 % with warfarin versus 2.75 % with high-dose edoxaban ( hazard ratio , 0.80 ; 95 % CI , 0.71 to 0.91 ; P < 0.001 ) and 1.61 % with low-dose edoxaban ( hazard ratio , 0.47 ; 95 % CI , 0.41 to 0.55 ; P < 0.001 ) .


The corresponding annualized rates of death from cardiovascular causes were 3.17 % versus 2.74 % ( hazard ratio , 0.86 ; 95 % CI , 0.77 to 0.97 ; P = 0.01 ) , and 2.71 % ( hazard ratio , 0.85 ; 95 % CI , 0.76 to 0.96 ; P = 0.008 ) , and the corresponding rates of the key secondary end point ( a composite of stroke , systemic embolism , or death from cardiovascular causes ) were 4.43 % versus 3.85 % ( hazard ratio , 0.87 ; 95 % CI , 0.78 to 0.96 ; P = 0.005 ) , and 4.23 % ( hazard ratio , 0.95 ; 95 % CI , 0.86 to 1.05 ; P = 0.32 ) .


Both once-daily regimens of edoxaban were noninferior to warfarin with respect to the prevention of stroke or systemic embolism and were associated with significantly lower rates of bleeding and death from cardiovascular causes .


( Funded by Daiichi Sankyo Pharma Development ; ENGAGE AF-TIMI 48 ClinicalTrials.gov number , NCT00781391 . )


Interface choice is crucial for non-invasive ventilation ( NIV ) success .


We compared a new interface , the helmet next ( HN ) , with the facial mask ( FM ) and the standard helmet ( HS ) in twelve healthy volunteers .


In this study , five NIV trials were randomly applied , preceded and followed by a trial of unassisted spontaneous breathing ( SB ) .


Baseline settings , for example , 5 cmH2O of both inspiratory pressure support ( PS ) and positive end-expiratory pressure ( PEEP ) , were applied through FM , HS and HN , while increased settings ( PS and PEEP of 8 cmH2O ) were only applied through HS and HN .


We measured flow , airway , esophageal and gastric pressures , and calculated inspiratory effort indexes and trigger delays .


Comfort was assessed with a visual-analog-scale .


We found that FM , HS and HN at baseline settings were not significantly different with respect to inspiratory effort indexes and comfort .


Inspiratory trigger delay and time of synchrony ( TI , synchrony ) were significantly improved by FM compared to both helmets , whereas expiratory trigger delay was shorter with FM , as opposed to HS only .


HN at increased settings performed better than FM in decreasing inspiratory effort measured by pressure-time product of transdiaphragmatic pressure ( PTPdi ) / breath ( 10.79.9 versus 17.011.0 cmH2Os ) , and PTPdi/min ( 12896 versus 20481 cmH2Os/min ) , and PTPdi/L ( 12.69.9 versus 30.216.8 cmH2Os/L ) .


TI , synchrony was inferior between HN and HS at increased settings and FM .


HN might hold some advantages with respect to interaction and synchrony between subject and ventilator , but studies on patients are needed to confirm these findings .


ClinicalTrials.gov NCT01610960 .


The benefits of prophylactic central compartment lymph node dissection ( pCCND ) in papillary thyroid cancer ( PTC ) are still under investigation .


This treatment seems to reduce PTC recurrence/mortality rates but has a higher risk of surgical complications .


The lack of prospective randomized trials does not allow definitive recommendations .


The aim of this prospective randomized controlled study was to evaluate the clinical advantages and disadvantages of pCCND .


A total of 181 patients with PTC without evidence of preoperative/intraoperative lymph node metastases ( cN0 ) were randomly assigned to either Group A ( n = 88 ) and treated with total thyroidectomy ( TTx ) or Group B ( n = 93 ) and treated with TTx + pCCND .


After 5 years of followup , no difference was observed in the outcome of the two groups .


However , a higher percentage of Group A were treated with a higher number of ( 131 ) I courses ( P = .002 ) , whereas a higher prevalence of permanent hypoparathyroidism was observed in Group B ( P = .02 ) .


No preoperative predictors of central compartment lymph node metastases ( N1a ) were identified .


Only three patients were upstaged , and the therapeutic strategy changed in only one case .


cN0 patients with PTC treated either with TTx or TTx + pCCND showed a similar outcome .


One advantage of TTx + pCCND was a reduced necessity to repeat ( 131 ) I treatments , but the disadvantage was a higher prevalence of permanent hypoparathyroidism .


Almost 50 % of patients with PTC had micrometastatic lymph nodes in the central compartment , but none of the presurgical features analyzed , including BRAF mutation , was able to predict their presence ; moreover , to be aware of their presence does not seem to have any effect on the outcome .


The cause of death in patients with chronic kidney disease ( CKD ) varies with CKD severity , but variation has not been quantified .


Retrospective analysis of prospective randomized clinical trial .


We analyzed 4,038 individuals with anemia and diabetic CKD from TREAT , a randomized trial comparing darbepoetin alfa and placebo .


Baseline estimated glomerular filtration rate ( eGFR ) and protein-creatinine ratio ( PCR ) .


Cause of death as adjudicated by a blinded committee .


Median eGFR and PCR ranged from 20.6 mL/min/1 .73 m ( 2 ) and 4.1 g/g in quartile 1 ( Q1 ) to 47.0 mL/min/1 .73 m ( 2 ) and 0.1 g/g in Q4 ( P < 0.01 ) .


Of 806 deaths , 441 , 298 , and 67 were due to cardiovascular ( CV ) , non-CV , and unknown causes , respectively .


Cumulative CV mortality at 3 years was higher with lower eGFR ( Q1 , 15.5 % ; Q2 , 11.1 % ; Q3 , 11.2 % ; Q4 , 10.3 % ; P < 0.001 ) or higher PCR ( Q1 , 15.2 % ; Q2 , 12.3 % ; Q3 , 11.7 % ; Q4 , 9.0 % ; P < 0.001 ) .


Similarly , non-CV mortality was higher with lower eGFR ( Q1 , 12.7 % ; Q2 , 8.4 % ; Q3 , 6.7 % ; Q4 , 6.1 % ; P < 0.001 ) or higher PCR ( Q1 , 10.3 % ; Q2 , 7.9 % ; Q3 , 9.4 % ; Q4 , 6.4 % ; P = 0.01 ) .


Sudden death was 1.7-fold higher with lower eGFR ( P = 0.04 ) and 2.1-fold higher with higher PCR ( P < 0.001 ) .


Infection-related mortality was 3.3-fold higher in the lowest eGFR quartile ( P < 0.001 ) and 2.8-fold higher in the highest PCR quartile ( P < 0.02 ) .


The overall proportion of CV and non-CV deaths was not significantly different across eGFR or PCR quartiles .


Results may not be generalizable to nondiabetic CKD or diabetic CKD in the absence of anemia .


Measured GFR was not available .


In diabetic CKD , both lower baseline GFR and higher PCR are associated with higher CV and non-CV mortality rates , particularly from sudden death and infection .


Efforts to improve outcomes should focus on CV disease and early diagnosis and treatment of infection .


A culturally focused psychiatric ( CFP ) consultation service was implemented to increase engagement in mental health care and reduce depressive symptoms among adult Latino primary care patients .


The aim of this study was to assess preliminary efficacy of the CFP consultation service to reduce depressive symptoms .


In a randomized controlled study , primary care clinics were randomly selected to provide either the two-session CFP intervention or enhanced usual care .


For CFP intervention participants , study clinicians ( psychologists or psychiatrists ) provided a psychiatric assessment , psychoeducation , cognitive-behavioral tools , and tailored treatment recommendations ; primary care providers were provided a consultation summary .


Depressive symptoms ( as measured by the Quick Inventory of Depressive Symptomatology-Self Rated [ QIDS-SR ] ) were assessed at baseline and six-month follow-up .


Multiple regression analysis was conducted to evaluate whether CFP intervention participants showed greater improvement in depressive symptoms at follow-up , with control for baseline depression , clinic site , and significant covariates .


Participants ( N = 118 ) were primarily Spanish-monolingual speakers ( 64 % ) .


Although depressive symptoms remained in the moderate range for both groups from baseline to six months , symptom reduction was greater among CFP intervention participants ( meanSD change in QIDS-SR score = 3.465.48 ) than those in usual care ( change = .094.43 ) .


The final multiple regression model indicated that participation in the CFP intervention predicted lower depressive symptoms at follow-up ( unstandardized beta = -3.09 , p = .008 ) , independent of baseline depressive symptoms , clinic site , age , gender , and employment status .


Results suggest that Latinos experiencing depressive symptoms may benefit from a short-term CFP consultation .


Findings also support the integration of psychiatric interventions for Latinos in the primary care setting .


Sentinel-node biopsy , a minimally invasive procedure for regional melanoma staging , was evaluated in a phase 3 trial .


We evaluated outcomes in 2001 patients with primary cutaneous melanomas randomly assigned to undergo wide excision and nodal observation , with lymphadenectomy for nodal relapse ( observation group ) , or wide excision and sentinel-node biopsy , with immediate lymphadenectomy for nodal metastases detected on biopsy ( biopsy group ) .


Results No significant treatment-related difference in the 10-year melanoma-specific survival rate was seen in the overall study population ( 20.8 % with and 79.2 % without nodal metastases ) .


Mean ( SE ) 10-year disease-free survival rates were significantly improved in the biopsy group , as compared with the observation group , among patients with intermediate-thickness melanomas , defined as 1.20 to 3.50 mm ( 71.3 1.8 % vs. 64.7 2.3 % ; hazard ratio for recurrence or metastasis , 0.76 ; P = 0.01 ) , and those with thick melanomas , defined as > 3.50 mm ( 50.7 4.0 % vs. 40.5 4.7 % ; hazard ratio , 0.70 ; P = 0.03 ) .


Among patients with intermediate-thickness melanomas , the 10-year melanoma-specific survival rate was 62.1 4.8 % among those with metastasis versus 85.1 1.5 % for those without metastasis ( hazard ratio for death from melanoma , 3.09 ; P < 0.001 ) ; among patients with thick melanomas , the respective rates were 48.0 7.0 % and 64.6 4.9 % ( hazard ratio , 1.75 ; P = 0.03 ) .


Biopsy-based management improved the 10-year rate of distant disease-free survival ( hazard ratio for distant metastasis , 0.62 ; P = 0.02 ) and the 10-year rate of melanoma-specific survival ( hazard ratio for death from melanoma , 0.56 ; P = 0.006 ) for patients with intermediate-thickness melanomas and nodal metastases .


Accelerated-failure-time latent-subgroup analysis was performed to account for the fact that nodal status was initially known only in the biopsy group , and a significant treatment benefit persisted .


Biopsy-based staging of intermediate-thickness or thick primary melanomas provides important prognostic information and identifies patients with nodal metastases who may benefit from immediate complete lymphadenectomy .


Biopsy-based management prolongs disease-free survival for all patients and prolongs distant disease-free survival and melanoma-specific survival for patients with nodal metastases from intermediate-thickness melanomas .


( Funded by the National Cancer Institute , National Institutes of Health , and the Australia and New Zealand Melanoma Trials Group ; ClinicalTrials.gov number , NCT00275496 . )


Few studies have evaluated the effects of rabeprazole on low-dose aspirin ( LDA ) - induced gastroduodenal injuries .


To conduct a randomised , double-blind , triple-dummy , active-controlled , multicentre trial , named the PLANETARIUM study , to assess the efficacy , dose-response relationship and safety of rabeprazole for peptic ulcer recurrence in Japanese patients on long-term LDA therapy .


Eligible patients had a history of endoscopically confirmed peptic ulcers and were receiving long-term LDA ( 81 or 100 mg/day ) therapy for cardiovascular or cerebrovascular protection .


Subjects were randomly segregated into three groups receiving rabeprazole 10 mg once daily ( standard dose in Japan ) , rabeprazole 5 mg once daily , or teprenone ( geranylgeranylacetone ; mucosal protective agent commercially available in Japan ) 50 mg three times per day as an active control .


The primary endpoint was recurrence of peptic ulcers over 24 weeks .


Among 472 randomised subjects , 452 subjects ( n = 151 , 150 , 151 , respectively ) constituted the full analysis set .


The cumulative recurrence rates of peptic ulcers over 24 weeks in the 10 - and 5-mg rabeprazole groups were 1.4 % and 2.8 % , respectively , both of which were significantly lower than that in the teprenone group ( 21.7 % ) .


The cumulative occurrence rate of bleeding ulcers over 24 weeks in the teprenone group was 4.6 % , while bleeding ulcers were not observed in the 10 - or 5-mg rabeprazole groups .


Rabeprazole was well tolerated at both doses .


Rabeprazole prevents the recurrence of peptic ulcers with no evidence of a major dose-response effect in subjects on low-dose aspirin therapy .


Nintedanib ( formerly known as BIBF 1120 ) is an intracellular inhibitor that targets multiple tyrosine kinases .


A phase 2 trial suggested that treatment with 150 mg of nintedanib twice daily reduced lung-function decline and acute exacerbations in patients with idiopathic pulmonary fibrosis .


We conducted two replicate 52-week , randomized , double-blind , phase 3 trials ( INPULSIS-1 and INPULSIS-2 ) to evaluate the efficacy and safety of 150 mg of nintedanib twice daily as compared with placebo in patients with idiopathic pulmonary fibrosis .


The primary end point was the annual rate of decline in forced vital capacity ( FVC ) .


Key secondary end points were the time to the first acute exacerbation and the change from baseline in the total score on the St. George 's Respiratory Questionnaire , both assessed over a 52-week period .


A total of 1066 patients were randomly assigned in a 3:2 ratio to receive nintedanib or placebo .


The adjusted annual rate of change in FVC was -114.7 ml with nintedanib versus -239.9 ml with placebo ( difference , 125.3 ml ; 95 % confidence interval [ CI ] , 77.7 to 172.8 ; P < 0.001 ) in INPULSIS-1 and -113.6 ml with nintedanib versus -207.3 ml with placebo ( difference , 93.7 ml ; 95 % CI , 44.8 to 142.7 ; P < 0.001 ) in INPULSIS-2 .


In INPULSIS-1 , there was no significant difference between the nintedanib and placebo groups in the time to the first acute exacerbation ( hazard ratio with nintedanib , 1.15 ; 95 % CI , 0.54 to 2.42 ; P = 0.67 ) ; in INPULSIS-2 , there was a significant benefit with nintedanib versus placebo ( hazard ratio , 0.38 ; 95 % CI , 0.19 to 0.77 ; P = 0.005 ) .


The most frequent adverse event in the nintedanib groups was diarrhea , with rates of 61.5 % and 18.6 % in the nintedanib and placebo groups , respectively , in INPULSIS-1 and 63.2 % and 18.3 % in the two groups , respectively , in INPULSIS-2 .


In patients with idiopathic pulmonary fibrosis , nintedanib reduced the decline in FVC , which is consistent with a slowing of disease progression ; nintedanib was frequently associated with diarrhea , which led to discontinuation of the study medication in less than 5 % of patients .


( Funded by Boehringer Ingelheim ; INPULSIS-1 and INPULSIS-2 ClinicalTrials.gov numbers , NCT01335464 and NCT01335477 . )


Approximately 30 % of children younger than 3 years experience at least 1 episode of wheezing .


Antiasthmatic medication is routinely prescribed , but its effectiveness remains unclear .


Our study was aimed to evaluate the effect of anti-inflammatory treatment on frequency and severity of preschool wheeze episodes ( PWEs ) .


Children aged 6 to 36 months with the first up to the third PWE were randomly assigned to receive montelukast , fluticasone , or no treatment for 12 weeks .


The outcome measures were the number of PWEs , the number of hospitalizations due to PWE , and the severity of respiratory symptoms .


results : There were no significant differences in outcome measures between the groups .


However , tobacco-exposed children treated with fluticasone had significantly fewer PWEs ( P = .01 ) .


Neither montelukast nor fluticasone has proven effective in the prevention of PWE recurrence .


Children of smoking parents may benefit from fluticasone treatment after PWE .


This observation requires confirmation in larger studies .


The efficacy of antibiotic prophylaxis for the prevention of surgical-site infection ( SSI ) after open tension-free inguinal hernia repair remains controversial .


A double-blind , randomized , placebo-controlled trial was conducted .


Patients who underwent elective open mesh-plug hernia repair were eligible for randomization .


In the antibiotic prophylaxis group , 1.0 g cefazolin was intravenously administrated 30 minutes before the incision .


In the placebo group , an equal volume of sterile saline was administered .


The primary end point was the incidence of SSI .


A total of 200 patients were enrolled .


SSI developed in 2 of 100 patients ( 2 % ) in the antibiotic prophylaxis group and 13 of 100 patients ( 13 % ) in the placebo group , indicating a significant difference between the 2 groups ( relative risk ratio , 0.25 ; 95 % confidence interval , 0.070 to 0.92 ; P = .003 ) .


Other complications occurred in 23 patients : 7 ( 7 % ) in the antibiotic prophylaxis group and 16 ( 16 % ) in the placebo group ( P = .046 ) .


This study indicates that antibiotic prophylaxis is effective for the prevention of SSI after open mesh-plug hernia repair .


Postoperative radiation therapy for stage I endometrial cancer improves locoregional control but is without survival benefit .


To facilitate treatment decision support for individual patients , accurate statistical models to predict locoregional relapse ( LRR ) , distant relapse ( DR ) , overall survival ( OS ) , and disease-free survival ( DFS ) are required .


Clinical trial data from the randomized Post Operative Radiation Therapy for Endometrial Cancer ( PORTEC-1 ; N = 714 patients ) and PORTEC-2 ( N = 427 patients ) trials and registered group ( grade 3 and deep invasion , n = 99 ) were pooled for analysis ( N = 1240 ) .


For most patients ( 86 % ) pathology review data were available ; otherwise original pathology data were used .


Trial variables which were clinically relevant and eligible according to data constraints were age , stage , given treatment ( pelvic external beam radiation therapy ( EBRT ) , vaginal brachytherapy ( VBT ) , or no adjuvant treatment , FIGO histological grade , depth of invasion , and lymph-vascular invasion ( LVSI ) .


Multivariate analyses were based on Cox proportional hazards regression model .


Predictors were selected based on a backward elimination scheme .


Model results were expressed by the c-index ( 0.5-1 .0 ; random to perfect prediction ) .


Two validation sets ( n = 244 and 291 patients ) were used .


Accuracy of the developed models was good , with training accuracies between 0.71 and 0.78 .


The nomograms validated well for DR ( 0.73 ) , DFS ( 0.69 ) , and OS ( 0.70 ) , but validation was only fair for LRR ( 0.59 ) .


Ranking of variables as to their predictive power showed that age , tumor grade , and LVSI were highly predictive for all outcomes , and given treatment for LRR and DFS .


The nomograms were able to significantly distinguish low - from high-probability patients for these outcomes .


The nomograms are internally validated and able to accurately predict long-term outcome for endometrial cancer patients with observation , pelvic EBRT , or VBT after surgery .


These models facilitate decision support in daily clinical practice and can be used for patient counseling and shared decision making , selecting patients who benefit most from adjuvant treatment , and generating new hypotheses .


The detailed mechanism of plaque stabilization by statin therapy is not fully understood .


The aim of this study was to assess the effect of lipid-lowering therapy with 20 mg/day of atorvastatin versus 5 mg/day of atorvastatin on fibrous cap thickness in coronary atherosclerotic plaques by using optical coherence tomography ( OCT ) .


Seventy patients with unstable angina pectoris and untreated dyslipidemia were randomized to either 20mg/day or 5 mg/day of atorvastatin therapy .


OCT was performed to assess intermediate nonculprit lesions at baseline and 12-month follow-up .


Serum low-density lipoprotein cholesterol level was significantly lower during therapy with 20 mg/day compared with 5 mg/day of atorvastatin ( 69 mg/dl vs. 78 mg/dl ; p = 0.039 ) .


The increase in fibrous cap thickness was significantly greater with 20 mg/day compared with 5 mg/day of atorvastatin ( 69 % vs. 17 % ; p < 0.001 ) .


The increase in fibrous cap thickness correlated with the decrease in serum levels of low-density lipoprotein cholesterol ( R = -0.450 ; p < 0.001 ) , malondialdehyde-modified low-density lipoprotein ( R = -0.283 ; p = 0.029 ) , high-sensitivity C-reactive protein ( R = -0.276 ; p = 0.033 ) , and matrix metalloproteinase-9 ( R = -0.502 ; p < 0.001 ) , and the decrease in grade of OCT-derived macrophages ( R = -0.415 ; p = 0.003 ) .


Atorvastatin therapy at 20 mg/day provided a greater increase in fibrous cap thickness in coronary plaques compared with 5 mg/day of atorvastatin .


The increase of fibrous cap was associated with the decrease in serum atherogenic lipoproteins and inflammatory biomarkers during atorvastatin therapy .


( Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography : The EASY-FIT Study ; NCT00700037 ) .


In patients treated with oral anticoagulants , subcutaneous injections of anti-tetanus vaccine are usually recommended to reduce the risk of bleeding , although the effectiveness of the vaccine has only been proven for intramuscular injection .


The objective of this study was to compare the safety and efficacy of intramuscular and subcutaneous injections of tetanus-diphtheria vaccine in patients treated with oral anticoagulants .


We present a prospective , double blinded , clinical trial comparing two groups of patients with oral anticoagulants : one group was administered tetanus-diphtheria vaccine by intramuscular injection , while the other was administered the same vaccine by subcutaneous injection .


Allocation to each group was randomized and the duration of the study was six years .


all patients treated with oral anticoagulants , who had been administered with at least one dose of vaccine , at 15 Health Centres in Vigo ( Spain ) , and who agreed to participate in the study .


The sample size was 115 patients in each group .


The main variables for the safety analysis were the measurement of the brachial diameter , the appearance of basic injuries at the vaccine administration site , the appearance of pain and systemic reactions .


The variable used for the efficacy analysis was a significant increase in the titres of anti-tetanus toxoid antibodies.An Intention-to-treat analysis will be performed .


Details will be classified according to the administration route , while within each group a 3-tiered stratification will be defined by the administered number of doses .


As a measure of association , relative risk will be estimated ; the reduction of relative risk will also measured .


For safety and to control the confounder effect , a logistic regression analysis will be carried out .


As a measure of impact the reduction of absolute risk in relation to the total number of patients to be treated and the Number Needed to Treat will be estimated.CONSORT 2010 guidelines were applied for reporting parallel group randomised trials .


The most significant difficulties on the project are related to the large number of participating centres , required to obtain a viable study population sample size , and the coordination given the scattering of the centres and researchers .


ISRCTN69942081 .


Insulin regulates the GH-IGF1 axis .


Insulin analogs differ from human insulin in receptor affinity and possibly liver accessibility .


Therefore , we compared the GH-IGF1 axis response with human NPH insulin , insulin detemir , and insulin glargine in patients with type 1 diabetes ( T1D ) .


A total of 17 patients ( seven were women ) with T1D ( age of 42 ( 24-63 ) years ( mean and range ) , BMI of 24.7 ( 19.5-28 .3 ) kg/m ( 2 ) , HbA1c of 7.2 ( 6.3-8 .0 ) % ( 55 ( 45-64 ) mmol/mol ) , T1D duration of 26 ( 8-45 ) years ) were studied using a randomized , three-period crossover design .


Patients received s.c. injections of equal , individual doses of NPH , detemir , and glargine at 1800h .


Plasma glucose , serum total IGF1 , bioactive IGF , IGF-binding protein ( IGFBPs ) , and GH were measured hourly for 14h post-injection .


When compared with the area under the curve ( AUC ) following NPH and glargine , detemir resulted in the lowest 6-14h AUC ( mean and range ) of IGFBP1 ( 1518 ( 1280-1800 ) ) vs 1621 ( 1367-1922 ) vs 1020 ( 860-1210 ) g/lh ) and GH ( 17.1 ( 14.1-20 .6 ) vs 15.4 ( 12.7-18 .6 ) vs 10.2 ( 8.5-12 .3 ) g/lh ) , but in the highest AUC of bioactive IGF ( 3.8 ( 3.5-4 .2 ) vs 3.7 ( 3.4-4 .0 ) vs 4.4 ( 4.1-4 .8 ) g/lh ) ( all P < 0.01 ) .


These differences were unrelated to plasma glucose .


By contrast , profiles of total IGF1 , IGFBP2 , and IGFBP3 were comparable .


Independent of plasma glucose , a single dose of detemir caused larger suppression in serum IGFBP1 than NPH and glargine , whereas bioactive IGF was higher , thereby explaining the lower GH levels .


Thus , detemir appears to be more liver specific than NPH insulin and glargine .


Nivolumab was associated with higher rates of objective response than chemotherapy in a phase 3 study involving patients with ipilimumab-refractory metastatic melanoma .


The use of nivolumab in previously untreated patients with advanced melanoma has not been tested in a phase 3 controlled study .


We randomly assigned 418 previously untreated patients who had metastatic melanoma without a BRAF mutation to receive nivolumab ( at a dose of 3 mg per kilogram of body weight every 2 weeks and dacarbazine-matched placebo every 3 weeks ) or dacarbazine ( at a dose of 1000 mg per square meter of body-surface area every 3 weeks and nivolumab-matched placebo every 2 weeks ) .


The primary end point was overall survival .


At 1 year , the overall rate of survival was 72.9 % ( 95 % confidence interval [ CI ] , 65.5 to 78.9 ) in the nivolumab group , as compared with 42.1 % ( 95 % CI , 33.0 to 50.9 ) in the dacarbazine group ( hazard ratio for death , 0.42 ; 99.79 % CI , 0.25 to 0.73 ; P < 0.001 ) .


The median progression-free survival was 5.1 months in the nivolumab group versus 2.2 months in the dacarbazine group ( hazard ratio for death or progression of disease , 0.43 ; 95 % CI , 0.34 to 0.56 ; P < 0.001 ) .


The objective response rate was 40.0 % ( 95 % CI , 33.3 to 47.0 ) in the nivolumab group versus 13.9 % ( 95 % CI , 9.5 to 19.4 ) in the dacarbazine group ( odds ratio , 4.06 ; P < 0.001 ) .


The survival benefit with nivolumab versus dacarbazine was observed across prespecified subgroups , including subgroups defined by status regarding the programmed death ligand 1 ( PD-L1 ) .


Common adverse events associated with nivolumab included fatigue , pruritus , and nausea .


Drug-related adverse events of grade 3 or 4 occurred in 11.7 % of the patients treated with nivolumab and 17.6 % of those treated with dacarbazine .


Nivolumab was associated with significant improvements in overall survival and progression-free survival , as compared with dacarbazine , among previously untreated patients who had metastatic melanoma without a BRAF mutation .


( Funded by Bristol-Myers Squibb ; CheckMate 066 ClinicalTrials.gov number , NCT01721772 . )


Maaori are the Indigenous people of New Zealand and do not enjoy the same oral health status as the non-Indigenous majority .


To overcome oral health disparities , the life course approach affords a valid foundation on which to develop a process that will contribute to the protection of the oral health of young infants .


The key to this process is the support that could be provided to the parents or care givers of Maaori infants during the pregnancy of the mother and the early years of the child .


This study seeks to determine whether implementing a kaupapa Maaori ( Maaori philosophical viewpoint ) in an early childhood caries ( ECC ) intervention reduces dental disease burden among Maaori children .


The intervention consists of four approaches to prevent early childhood caries : dental care provided during pregnancy , fluoride varnish application to the teeth of children , motivational interviewing , and anticipatory guidance .


The participants are Maaori women who are expecting a child and who reside within the Maaori tribal area of Waikato-Tainui .


This randomised-control trial will be undertaken utilising the principles of kaupapa Maaori research , which encompasses Maaori leadership , Maaori relationships , Maaori customary practices , etiquette and protocol .


Participants will be monitored through clinical and self-reported information collected throughout the ECC intervention .


Self-report information will be collected in a baseline questionnaire during pregnancy and when children are aged 24 and 36 months .


Clinical oral health data will be collected during standardised examinations at ages 24 and 36 months by calibrated dental professionals .


All participants receive the ECC intervention benefits , with the intervention delayed by 24 months for participants who are randomised to the control-delayed arm .


The development and evaluation of oral health interventions may produce evidence that supports the application of the principles of kaupapa Maaori research in the research processes .


This study will assess an ECC intervention which could provide a meaningful approach for Maaori for the protection and maintenance of oral health for Maaori children and their family , thus reducing oral health disparities .


Australia and New Zealand Clinical Trials Register ( ANZCTR ) : ACTRN12611000111976 .


The surgical Apgar score ( SAS ) can predict 30-day major complications or death after surgery .


Studies have validated the score in different patient populations and suggest it should be used to objectively guide postoperative care .


We aimed to see whether using the SAS in a decisive approach in a future randomised controlled trial ( RCT ) would be likely to demonstrate an effect on postoperative care and clinical outcome .


A total of 143 adults undergoing general/vascular surgery in 9 National Health Service hospitals were recruited to a pilot single blinded RCT and the data for 139 of these were analysed .


Participants were randomised to a control group with standard postoperative care or to an intervention group with care influenced ( but not mandated ) by the SAS ( decisive approach ) .


The notional primary outcome was 30-day major complications or death .


Incidence of major complications was similar in both groups ( control : 20/69 [ 29 % ] , intervention : 23/70 [ 33 % ] , p = 0.622 ) .


Immediate admissions to the critical care unit was higher in the intervention group , especially in the SAS 0-4 subgroup ( 4/6 vs 2/7 ) although this was not statistically significant ( p = 0.310 ) .


Validity was also confirmed in area under the curve ( AUC ) analysis ( AUC : 0.77 ) .


This pilot study found that a future RCT to investigate the effect of using the SAS in a decisive approach may demonstrate a difference in postoperative care .


However , significant changes to the design are needed if differences in clinical outcome are to be achieved reliably .


These would include a wider array of postoperative interventions implemented using a quality improvement approach in a stepped wedge cluster design with blinded collection of outcome data .


To investigate if patients with thyroid carcinoma having N1a disease are at the same risk with N1b using the collective of the well-defined European prospective Multicentre Study Differentiated Thyroid Cancer ( MSDS ) .


Overall ( OS ) and event free survival ( EFS ) were calculated .


Cox multivariable regression analysis was performed in order to calculate Hazard ratios ( HR ) .


EFS was significantly decreased only in patients with N1b metastasis as compared to N0 patients and became worse when N1a was concomitantly affected .


A superior survival in favor of N1a patients as compared to N1b patients with regard to EFS was also observed .


The patients having N1a disease showed no differences in the EFS as compared to N0 .


OS did not differ significantly in any of the groups .


There was an increased HR for events with regards to histology , T-stage , tumor size , UICC stage and cervical lymph node metastasis .


Tumor size showed a significantly increased risk for OS .


Patients with pT3b and pT4a tumors with N1b are of higher risk for relapse , albeit not affecting overall survival .


Patients with N1a are of no higher risk .


The risk stratification of these patients may be adapted accordingly .


A single randomized trial established lobectomy as the standard of care for the surgical treatment of early-stage non-small cell lung cancer .


Recent advances in imaging/staging modalities and detection of smaller tumors have once again rekindled interest in sublobar resection for early-stage disease .


The objective of this study was to compare lung cancer survival in patients with non-small cell lung cancer with a diameter of 30 mm or less with clinical stage 1 disease who underwent lobectomy or sublobar resection .


We identified 347 patients diagnosed with lung cancer who underwent lobectomy ( n = 294 ) or sublobar resection ( n = 53 ) for non-small cell lung cancer manifesting as a solid nodule in the International Early Lung Cancer Action Program from 1993 to 2011 .


Differences in the distribution of the presurgical covariates between sublobar resection and lobectomy were assessed using unadjusted P values determined by logistic regression analysis .


Propensity scoring was performed using the same covariates .


Differences in the distribution of the same covariates between sublobar resection and lobectomy were assessed using adjusted P values determined by logistic regression analysis with adjustment for the propensity scores .


Lung cancer-specific survival was determined by the Kaplan-Meier method .


Cox survival regression analysis was used to compare sublobar resection with lobectomy , adjusted for the propensity scores , surgical , and pathology findings , when adjusted and stratified by propensity quintiles .


Among 347 patients , 10-year Kaplan-Meier for 53 patients treated by sublobar resection compared with 294 patients treated by lobectomy was 85 % ( 95 % confidence interval , 80-91 ) versus 86 % ( confidence interval , 75-96 ) ( P = .86 ) .


Cox survival analysis showed no significant difference between sublobar resection and lobectomy when adjusted for propensity scores or when using propensity quintiles ( P = .62 and P = .79 , respectively ) .


For those with cancers 20 mm or less in diameter , the 10-year rates were 88 % ( 95 % confidence interval , 82-93 ) versus 84 % ( 95 % confidence interval , 73-96 ) ( P = .45 ) , and Cox survival analysis showed no significant difference between sublobar resection and lobectomy using either approach ( P = .42 and P = .52 , respectively ) .


Sublobar resection and lobectomy have equivalent survival for patients with clinical stage IA non-small cell lung cancer in the context of computed tomography screening for lung cancer .


To assess the effects of postural rehabilitation ( PR ) on trunk asymmetry and balance , with and without Kinesio taping ( KT ) of the back muscles as additional treatment , in patients with Parkinson 's disease ( PD ) who have postural disorders .


Single-blind , randomized controlled trial with 1-month follow-up .


Ambulatory care in referral center .


Patients ( N = 20 ) with PD showing postural abnormalities of the trunk , in the sagittal and/or coronal plane .


Four weeks of patient-tailored proprioceptive and tactile stimulation , combined with stretching and postural reeducation , was provided to 13 subjects ( PR group ) , while 7 received no treatment ( control group ) .


Six of the 13 subjects receiving PR also had KT strips applied to their trunk muscles , according to the features of their postural abnormalities .


Berg Balance Scale , Timed Up and Go , and degrees of trunk bending in the sagittal and coronal planes were assessed at the enrollment ( t0 ) , 1 month later ( t1 ) , and 2 months later ( t2 ) .


At t1 , all treated patients showed a significant improvement in trunk posture in both the sagittal ( P = .002 ) and coronal planes ( P = .01 ) , compared with baseline .


Moreover , they showed an improvement in measures of gait and balance ( P < .01 ) .


Benefits persisted at t2 for all measures , except lateral trunk bend .


No differences were found when comparing the PR and KT groups .


The combination of active posture correction and trunk movements , muscle stretching , and proprioceptive stimulation may usefully impact PD axial symptoms .


Repeated training is advocated to avoid waning of the effect .


To study the effect of a countermovement on the lower limb force-velocity ( F-v ) mechanical profile and to experimentally test the influence of F-v mechanical profile on countermovement jump ( CMJ ) performance , independently from the effect of maximal power output ( P max ) .


Fifty-four high-level sprinters and jumpers performed vertical maximal CMJ and squat jump ( SJ ) against five to eight additional loads ranging from 17 to 87 kg .


Vertical ground reaction force data were recorded ( 1,000 Hz ) and used to compute center of mass vertical displacement .


For each condition , mean force , velocity , and power output were determined over the entire push-off phase of the best trial , and used to determine individual linear F-v relationships and P max .


From a previously validated biomechanical model , the optimal F-v profile maximizing jumping performance was determined for each subject and used to compute the individual mechanical F-v imbalance ( Fv IMB ) as the difference between actual and optimal F-v profiles .


A multiple regression analysis clearly showed ( r ( 2 ) = 0.952 , P < 0.001 , SEE 0.011 m ) that P max , Fv IMB and lower limb extension range ( h PO ) explained a significant part of the interindividual differences in CMJ performance ( P < 0.001 ) with positive regression coefficients for P max and h PO and a negative one for Fv IMB .


Compared to SJ , F-v relationships were shifted to the right in CMJ , with higher P max , maximal theoretical force and velocity ( +35.8 , 20.6 and 13.3 % , respectively ) .


As in SJ , CMJ performance depends on Fv IMB , independently from the effect of P max , with the existence of an individual optimal F-v profile ( Fv IMB having an even larger influence in CMJ ) .


To investigate whether retesting with the oral glucose tolerance test ( OGTT ) is useful and necessary for all women with polycystic ovary syndrome ( PCOS ) .


Follow-up study .


Tertiary medical center .


Eighty-four women with PCOS and 45 healthy controls .


Peripheral venous blood sampling .


We performed a 75-g 2-hour OGTT in women with normal glucose tolerance ( NGT ) and impaired glucose tolerance ( IGT ) at the time of the first test with and without PCOS .


The average follow-up period for women with PCOS was 2.6 years ( range , 2-4 .17 years ) .


Seventy-eight of these women had NGT at baseline , 11.5 % converted to IGT , with an annualized incidence rate of 4.5 % .


Of those women with IGT at baseline ( n = 6 ) , 33.3 % converted to type 2 diabetes mellitus , with an annualized incidence rate of 10.4 % .


In the healthy subjects , the average follow-up period was 2.6 years ( range , 2-4 .08 years ) .


Forty-two of these women had NGT at baseline , 2.3 % converted to IGT , giving a progression of 0.9 % per year .


Among the three women with IGT at baseline , 33.3 % reverted to NGT , and 66.6 % had persistent IGT .


Conversion rates from NGT to IGT or type 2 diabetes mellitus were accelerated in women with PCOS compared with healthy subjects .


Women with PCOS should be tested regularly for early detection of abnormal glucose tolerance .


In addition , the interval for periodic rescreening should be determined by further studies involving more women with PCOS .


To verify the nutritive and non-nutritive stimuli efficacy in the newborn 's response to pain during venipuncture .


The main sample was composed of 64 newborns that were randomly divided into three groups .


The first group ( n = 20 ) received nutritive sucking stimulus that was performed through maternal breastfeeding .


The second group ( n = 21 ) received non-nutritive sucking stimulus that was performed through the introduction of the researcher little finger in the newborn 's oral cavity .


The third group or control group ( n = 23 ) did not receive any analgesia stimulus .


The newborns were evaluated using the Neonatal Infant Pain Scale , and the responses to painful stimuli were compared .


The nutritive as well as non-nutritive suction methods provided a comforting effect , resulting in lower pain response scores ( p < 0.05 ) .


There was no difference between the analgesia provided by both methods ( p > 0.05 ) .


The nutritive and the non-nutritive sucking stimuli proved to be efficacious tools in relieving pain among newborns .


At northern latitudes , vitamin D is not synthesized endogenously during winter , causing low plasma 25-hydroxyvitamin D ( 25 ( OH ) D ) concentrations .


Therefore , we evaluated the effects of a healthy Nordic diet based on Nordic nutrition recommendations ( NNR ) on plasma 25 ( OH ) D and explored its dietary predictors .


In a Nordic multi-centre trial , subjects ( n = 213 ) with metabolic syndrome were randomized to a control or a healthy Nordic diet favouring fish ( 300g/week , including 200g/week fatty fish ) , whole-grain products , berries , fruits , vegetables , rapeseed oil and low-fat dairy products .


Plasma 25 ( OH ) D and parathyroid hormone were analysed before and after 18 - to 24-week intervention .


At baseline , 45 % had vitamin D inadequacy ( < 50nmol/l ) , whereas 8 % had deficiency ( < 25nmol/l ) .


Dietary vitamin D intake was increased by the healthy Nordic diet ( P < 0.001 ) .


The healthy Nordic and the control diet reduced the prevalence of vitamin D inadequacy by 42 % ( P < 0.001 ) and 19 % ( P = 0.002 ) , respectively , without between-group difference ( P = 0.142 ) .


Compared with control , plasma 25 ( OH ) D ( P = 0.208 ) and parathyroid hormone ( P = 0.207 ) were not altered by the healthy Nordic diet .


Predictors for 25 ( OH ) D were intake of vitamin D , eicosapentaenoic acids ( EPA ) , docosahexaenoic acids ( DHA ) , vitamin D supplement , plasma EPA and plasma DHA .


Nevertheless , only vitamin D intake and season predicted the 25 ( OH ) D changes .


Consuming a healthy Nordic diet based on NNR increased vitamin D intake but not plasma 25 ( OH ) D concentration .


The reason why fish consumption did not improve vitamin D status might be that many fish are farmed and might contain little vitamin D or that frying fish may result in vitamin D extraction .


Additional ways to improve vitamin D status in Nordic countries may be needed .


To evaluate the effects of intravenous ( IV ) or intramuscular ( IM ) hyoscine premedication on physiologic variables following IV administration of medetomidine in horses .


Randomized , crossover experimental study .


Eight healthy crossbred horses weighing 330 39 kg and aged 7 4 years .


Baseline measurements of heart rate ( HR ) , cardiac index ( CI ) , respiratory rate , systemic vascular resistance ( SVR ) , percentage of patients with second degree atrioventricular ( 2 ( o ) AV ) block , mean arterial pressure ( MAP ) , pH , and arterial partial pressures of carbon dioxide ( PaCO2 ) and oxygen ( PaO2 ) were obtained 5 minutes before administration of IV hyoscine ( 0.14 mg kg ( -1 ) ; group HIV ) , IM hyoscine ( 0.3 mg kg ( -1 ) ; group HIM ) , or an equal volume of physiologic saline IV ( group C ) .


Five minutes later , medetomidine ( 7.5 g kg ( -1 ) ) was administered IV and measurements were recorded at various time points for 130 minutes .


Medetomidine induced bradycardia , 2 ( o ) AV blocks and increased SVR immediately after administration , without significant changes in CI or MAP in C. Hyoscine administration induced tachycardia and hypertension , and decreased the percentage of 2 ( o ) AV blocks induced by medetomidine .


Peak HR and MAP were higher in HIV than HIM at 88 18 beats minute ( -1 ) and 241 37 mmHg versus 65 16 beats minute ( -1 ) and 192 38 mmHg , respectively .


CI was increased significantly in HIV ( p 0.05 ) .


Respiratory rate decreased significantly in all groups during the recording period .


pH , PaCO2 and PaO2 were not significantly changed by administration of medetomidine with or without hyoscine .


Hyoscine administered IV or IM before medetomidine in horses resulted in tachycardia and hypertension under the conditions of this study .


The significance of these changes , and responses to other dose rates , requires further investigation .


Bone damage around the joints is one of the major pathophysiological mechanisms that leads to rheumatoid arthritis ( RA ) chronic disability .


Serum tartrate-resistant acid phosphatase 5b ( TRACP-5b ) is secreted by osteoclasts , its activity can be used as a clinically relevant bone resorption marker .


The aim of this study was to test whether the measurement of serum levels of TRACP-5b in patients with RA would correlate with measures of disease activity and with responses to therapy .


Fifty-six patients were randomly assigned to receive recombinant human cytotoxic tlymphocyte-associated antigen-4 immunoglobulin ( RhCTLA4-Ig ) , infliximab or methotrexate ( MTX ) .


The clinical and serologic indicators of RA activity were evaluated at baseline and at 24 weeks .


Serum TRACP-5b was measured by Enzyme-linked Immunosorbent Assay ( ELISA ) at 0 , 12 and 24 weeks .


Hand X-rays were obtained at baseline .


At baseline , the levels of TRACP-5b correlated with the severity of X-ray damage , disease duration ( r = 0.332 , P = 0.012 ) , and tender joint count ( r = 0.408 , P = 0.002 ) .


The 24 weeks values of TRACP-5b for RhCTLA4-Ig group and infliximab group differed significantly from the baseline values in each group ( P < 0.05 ; P < 0.05 ) , whereas only the value for RhCTLA4-Ig group differed significantly from the 24 weeks value for the MTX group ( P < 0.01 ) .


Considering the two biologics-treated groups together , the TRACP-5b levels at 24 weeks differed significantly from the baseline values only in those patients who reached an ACR70 level ( P < 0.05 ) .


Measurement of serum TRACP-5b in RA patients reflects clinical and radiological measures of disease activity , treatment with certain biologics , and degree of response to therapy .


TRACP-5b should be investigated further as a potential biomarker to predict response to therapy , including slowing of radiographic progression .


Different anesthetic techniques have been used for fast tracking in cardiac anesthesia .


Remifentanil , with its unique pharmacokinetic profile , could be an ideal drug for fast tracking .


Possible limitations of remifentanil are rapid onset of postoperative pain after discontinuation of the drug infusion , which may increase the risk of an ischemic event .


We conducted this randomized study to compare the efficacy of remifentanil versus low doses of fentanyl in fast-track cardiac anesthesia .


It has been hypothesized that remifentanil would provide a safe anesthesia with no impact on myocardial function and with positive effects on extubation time and mobilization .


We compared the postoperative course of patients , the remifentanil group ( RG ) and the low-dose fentanyl group ( LDFG ) , in whom remifentanil and low-dose fentanyl , respectively , were used for fast-track cardiac anesthesia .


The study was designed as a prospective randomized study .


The primary outcomes were changes in the cardiac index and creatine kinase MB fraction ( CKMB ) , extubation times , mobilization times , and lengths of stay in the intensive care unit ( ICU ) and the hospital .


Frequency of myocardial infarction ( MI ) , reoperations due to excessive bleeding , renal impairment , and cerebral complications were registered as well .


Seventy-one patients were enrolled in the study , and 7 were excluded due to difficult airway , bleeding , and technical difficulties .


The RG comprised 33 patients and the LDFG comprised of 31 patients .


There were no differences between the groups in terms of age , Euroscore , types of surgery , extracorporeal circulation , and aortic cross-clamp time .


We did not find significant difference in cardiac index , CKMB , extubation times , mobilization times , length of stay in the ICU and in the hospital between the groups .


Postoperative complications such as MI , rates of reoperations , renal and cerebral complications and incidence of atrial fibrillation did not show any significant differences .


Remifentanil fast-track anesthesia for cardiac patients has no negative impact on myocardial function .


Both remifentanil and low-dose fentanyl are equally effective and safe for fast-track cardiac anesthesia .


The study did not highlight any statistical superiority of remifentanil anesthesia over low-dose fentanyl anesthesia .


Rheumatoid arthritis ( RA ) patients are at an increased risk of developing comorbid conditions .


A close monitoring of the disease targeting a status of low disease activity is associated with a better outcome .


The aim of this trial was to evaluate the impact of a nurse-led programme on comorbidities and the impact of patient self-assessment of disease activity on the management of RA .


We enrolled 970 patients ( mean age 58years , 79 % women ) in a prospective , randomised , controlled , open-label , 6-month trial .


In the comorbidity group ( n = 482 ) , the nurse checked comorbidities and sent the programme results to the attending physicians .


In the self-assessment group ( n = 488 ) , the nurse taught the patient how to calculate his/her Disease Activity Score which had to be reported on a booklet to be shared with the treating rheumatologist .


The number of measures taken for comorbidities and the percentage of patients recording a change ( initiation , switch or increased dose ) in disease-modifying antirheumatic drugs ( DMARDs ) in the 6months follow-up period of the study defined the outcomes of the trial .


The number of measures taken per patient was statistically higher in the comorbidity group : 4.542.08 versus 2.651.57 ( p < 0.001 ) ; incidence rate ratio : 1.78 ( 1.61-1 .96 ) and DMARD therapy was changed more frequently in the self-assessment group : 17.2 % versus 10.9 % ( OR = 1.70 ( 1.17 ; 2.49 ) , p = 0.006 ) .


This study demonstrates the short-term benefit of a nurse-led programme on RA comorbidity management and the impact of patient self-assessment of disease activity on RA treatment intensification .


NCT # 01315652 .


The aim of the present study is to determine the long-term effects of a ten-week exercise training program in adult patients with a systemic right ventricle .


All patients who participated in a 2009 randomized controlled trial were approached .


At approximately three years of follow-up from initial baseline , patients underwent cardiopulmonary exercise testing , filled out two quality of life questionnaires , and NT proBNP levels were measured .


All examinations were performed according to the protocols of the 2009 trial .


In addition , patients were asked about their current sports habits .


Of the 54 patients who were randomized in the 2009-trial 40 participated in the current re-evaluation ( male 50 % , ccTGA 35 % , age 36 10 years , intervention group n = 22 , control group n = 18 ) .


After three years , no persistent effect of exercise training on V'Opeak training remained ( -2 % of predicted , 95 % CI -3 % to 5 % ; p = .56 ) .


However , patients who already participated in regular sports or exercise at baseline ( n = 23/40 ( 58 % ) ) showed higher V'Opeak of 13 % of predicted ( 95 % CI 4 % to 23 % ; p > .01 ) and a decrease of 62 % in plasma NT-proBNP ( 95 % CI -115 % to -10 % ; p > .03 ) during follow-up , when compared to patients who did not .


Moreover , sports were associated with a lower incidence of clinical events ( p = .032 ) .


Short-term beneficial effects of exercise training did not persist over a three-year follow-up period .


However , sports participation at baseline was associated with better exercise capacity , lower neurohormone levels , and increased event-free survival .


The objective of this study is to evaluate the impact of therapeutic HIV vaccination on the HIV reservoir and assess the relationship of the viral reservoir with HIV-specific immune status and viral rebound kinetics .


A retrospective analysis of ACTG A5197 , a randomized , placebo-controlled trial of a therapeutic rAd5 HIV-1 gag vaccine .


Participants received vaccine/placebo at weeks 0 , 4 and 26 prior to a 16-week analytic treatment interruption ( ATI ) at week 38 .


Cell-associated HIV-1 RNA and DNA ( CA-RNA and CA-DNA ) and HIV-1 residual viremia were quantified at weeks 0 , 8 and 38 .


HIV-specific CD4 ( + ) / CD8 ( + ) activity was assessed by an intracellular cytokine staining assay .


At study entry , CA-RNA and CA-DNA levels were correlated inversely with the numbers of HIV-specific CD4 ( + ) interferon - producing cells ( CA-RNA : r = -0.23 , P = 0.03 and CA-DNA : r = -0.28 , P < 0.01 , N = 93 ) .


Therapeutic HIV vaccination induced HIV-specific CD4 ( + ) activity , but did not significantly affect levels of CA-RNA or CA-DNA .


Vaccine recipients with undetectable residual viremia at week 8 had higher frequencies of HIV-specific CD4 ( + ) and CD8 ( + ) interferon - producing cells ( undetectable versus detectable residual viremia : 277 versus 161 CD4 ( + ) cells/10 ( 6 ) lymphocytes , P = 0.03 and 1326 versus 669 CD8 ( + ) cells/10 lymphocytes , P = 0.04 ) .


Pre-ATI CA-RNA and CA-DNA were associated with post-ATI plasma HIV set point ( CA-RNA : r = 0.51 , P < 0.01 and CA-DNA : r = 0.47 , P < 0.01 ) .


Vaccine-induced T-cell responses were associated with a modest transient effect on residual viremia , but more potent immune responses and/or combination treatment with latency-reversing agents are needed to reduce the HIV reservoir .


HIV reservoir measures may act as biomarkers of post-ATI viral rebound kinetics .


NCT00080106 .


To evaluate the ability of the Sonomat to diagnose obstructive sleep apnea ( OSA ) .


Prospective and randomized .


Sleep laboratory and home .


62 subjects ; 54 with a clinical history of OSA and 8 normal control subjects .


N/A .


Simultaneous PSG and Sonomat recordings were made in 62 subjects ; 2 were excluded due to a poor nasal flow recording in PSG .


There were positive correlations between the two devices for measures of sleep time , respiratory events , and the AHI ( all correlations > 0.89 ) .


Bland-Altman analysis of the AHI showed positive agreement between devices , particularly at levels around common diagnostic thresholds .


The mean difference in AHI values was 1.4 events per hour , and at a diagnostic threshold of 15 events per hour , sensitivity and specificity were 88 % and 91 % .


More than 93 % of PSG defined respiratory events were identified by the Sonomat and the absence of respiratory events was correctly identified in 91 % of occasions .


Gender , obesity , and body position did not influence the accuracy of the Sonomat .


PSG snore sensors differed in how much snoring was detected when compared to the Sonomat .


These data indicate that the Sonomat was reliable and accurate for the diagnosis of OSA .


The provision of audible breath sound/snoring replay permits more accurate quantification of snoring .


It requires no patient attachment and can be performed in the home with minimal training .


Long-term outcomes after lung transplantation are limited due to chronic lung allograft dysfunction ( CLAD ) .


Bronchiolitis obliterans syndrome ( BOS ) is the most common form of obstructive CLAD and its definition derives from spirometric measurements .


Given the importance of this diagnosis , both the accuracy and reliability of the definition of CLAD are crucial in understanding the pathophysiology of this disease to develop therapeutic options and influence outcome after lung transplantation .


A web-based survey was designed and distributed to members of the Pulmonary Council of the International Society for Heart and Lung Transplantation ( ISHLT ) to better understand the accuracy and reliability of pulmonary function criteria in diagnosing BOS .


Spirometric data from five patient scenarios that were discordant among reviewers regarding BOS determination from the Assessment of Immunosuppressive Regimen in Suppressing Acute and Chronic Rejection ( AIRSAC ) trial were randomly selected and summarized in this survey .


Survey questions included the respondent 's general understanding of the BOS definition , the determination of BOS , and difficulties with the current BOS definition .


Eighty-seven respondents from the Pulmonary Council of the ISHLT responded to this survey .


There was an overall 70 % interobserver agreement regarding the presence or absence of BOS .


Among those who agreed upon the presence of BOS , there was a 41 % interobserver agreement regarding its time of onset .


Despite this variability , the majority of respondents were not only familiar and agreed with the BOS criteria , they also felt confident in applying these criteria .


Our survey identified potential limitations with the current criteria for diagnosing BOS .


With recognition of the various CLAD phenotypes , further refinements of these diagnostic criteria will allow for an improved ability to identify and characterize patients who develop or are at risk for BOS , prognosticate outcomes , and , most importantly , marshal in future strategies directed at treating and preventing chronic lung dysfunction after lung transplantation .


Intravenous morphine has been used as a common method of pain control in emergency care .


Nebulized fentanyl is also an effective temporary substitute .


This study was designed to compare the effectiveness of nebulized fentanyl with intravenous ( IV ) morphine on management of acute limb pain .


This was a placebo-controlled , double-blind randomized clinical trial .


Ninety emergency department patients with moderate to severe pain aged 15 to 50 years were blocked randomized and enrolled in this study .


Forty-seven patients in the experimental group received nebulized fentanyl ( 4 g/kg ) and IV normal saline as placebo , and the remaining 43 patients in the control group received IV morphine ( 0.1 mg/kg ) and nebulized normal saline as placebo .


All participants ' pain scores were assessed by Numerical Rating Scale before and after intervention at 5 - , 10 - , 15 - , 30 - , 45 - , and 60-minute intervals .


Patients ' vital sign and possible adverse effects were recorded respectively .


Finally , all participants were assessed for their satisfaction .


The mean initial pain score in the experimental group was 8.7 and 8.4 in the control group ( P = .1 ) .


Pain relief in both groups after 5 and 10 minutes were similar ( P = .72 ) .


Although the pain relief was significantly greater with fentanyl at 15 minutes , this difference is not clinically significant .


Pain management in both groups was successful and was more than 3 scores reduction in Numerical Rating Scale .


Patient satisfaction in both groups was similar .


No adverse effects were reported in the experimental group .


This study suggests that nebulized fentanyl is a rapid , safe , and effective method for temporary control of acute limb pain in emergency department patients .


This prospective double-blinded , randomized controlled trial compared adductor canal block ( ACB ) with femoral nerve block ( FNB ) in patients undergoing total knee arthroplasty .


The authors hypothesized that ACB , compared with FNB , would exhibit less quadriceps weakness and demonstrate noninferior pain score and opioid consumption at 6 to 8 h postanesthesia .


Patients received an ACB or FNB as a component of a multimodal analgesic .


Quadriceps strength , pain score , and opioid consumption were assessed on both legs preoperatively and at 6 to 8 , 24 , and 48 h postanesthesia administration .


In a joint hypothesis test , noninferiority was first evaluated on the primary outcomes of strength , pain score , and opioid consumption at 6 to 8 h ; superiority on each outcome at 6 to 8 h was then assessed only if noninferiority was established .


Forty-six patients received ACB ; 47 patients received FNB .


At 6 to 8 h postanesthesia , ACB patients had significantly higher median dynamometer readings versus FNB patients ( median [ interquartile range ] , 6.1 kgf [ 3.5 , 10.9 ] ( ACB ) vs. 0 kgf [ 0.0 , 3.9 ] ( FNB ) ; P < 0.0001 ) , but was not inferior to FNB with regard to Numeric Rating Scale pain scores ( 1.0 [ 0.0 , 3.5 ] ACB vs. 0.0 [ 0.0 , 1.0 ] FNB ; P = 0.019 ) , or to opioid consumption ( 32.2 [ 22.4 , 47.5 ] ACB vs. 26.6 [ 19.6 , 49.0 ] ; P = 0.0115 ) .


At 24 and 48 h postanesthesia , there was no significant statistical difference in dynamometer results , pain scores , or opioid use between the two groups .


At 6 to 8 h postanesthesia , the ACB , compared with the FNB , exhibited early relative sparing of quadriceps strength and was not inferior in both providing analgesia or opioid intake .


Continuous subcutaneous insulin infusion ( CSII ) treatment among children with type 1 diabetes is increasing in Sweden .


However , studies evaluating glycaemic control in children using CSII show inconsistent results .


The distribution of responsibility for diabetes self-management between children and parents is often unclear and needs clarification .


There is much published support for continued parental involvement and shared diabetes management during adolescence .


Guided Self-Determination ( GSD ) is an empowerment-based , person-centred , reflection and problem solving method intended to guide the patient to become self-sufficient and develop life skills for managing difficulties in diabetes self-management .


This method has been adapted for adolescents and parents as Guided Self-Determination-Young ( GSD-Y ) .


This study aims to evaluate the effect of an intervention with GSD-Y in groups of adolescents starting on insulin pumps and their parents on diabetes-related family conflicts , perceived health and quality of life ( QoL ) , and metabolic control .


Here , we describe the protocol and plans for study enrollment .


This study is designed as a randomized , controlled , prospective , multicentre study .


Eighty patients between 12-18 years of age who are planning to start CSII will be included .


All adolescents and their parents will receive standard insulin pump training .


The education intervention will be conducted when CSII is to be started and at four appointments in the first 4 months after starting CSII .


The primary outcome is haemoglobin A1c levels .


Secondary outcomes are perceived health and QoL , frequency of blood glucose self-monitoring and bolus doses , and usage of carbohydrate counting .


The following instruments will be used : Disabkids , ` Check your health ' , the Diabetes Family Conflict Scale and the Swedish Diabetes Empowerment Scale .


Outcomes will be evaluated within and between groups by comparing data at baseline , and at 6 and 12 months after starting treatment .


In this study , we will assess the effect of starting an CSII together with the model of GSD to determine whether this approach leads to retention of improved glycaemic control , QoL , responsibility distribution and reduced diabetes-related conflicts in the family .


Nutrition in childhood has an influence on the cardiovascular function later on in life .


European Childhood Obesity Project is a multicenter , randomized clinical intervention trial examining the effect of early protein intake on later health outcomes , particularly adiposity and related disorders .


The aim of the study was to examine the effect of nutritional intervention -- different protein intake in infancy on carotid intima-media thickness ( cIMT ) at 5 years .


The association of cardiovascular risk factors with cIMT was also assessed .


Healthy term formula-fed infants in five European countries were enrolled either to the higher ( HP ) or to the lower ( LP ) protein group .


Observational group consisted of breastfed infants .


Plasma insulin , glucose , lipid profile , IGF-1 , apolipoprotein A1 and B were measured as well as anthropometric parameters of parents and a child , blood pressure and physical activity .


No difference in cIMT between HP and LP group was observed .


Insulin , HOMA-IR index and total IGF-1 were positively associated with cIMT but after adjustment for confounders only an inverse association between ApoA1 and positive between ApoB/ApoA1 and cIMT were significant .


High versus low protein intake in infancy does not influence cIMT at 5 years .


cIMT in healthy children at 5 years is associated with their apolipoprotein profile .


Compare the efficacy and safety of monotherapy with dulaglutide , a once-weekly GLP-1 receptor agonist , to metformin-treated patients with type 2 diabetes .


The primary objective compared dulaglutide 1.5 mg and metformin on change from baseline glycosylated hemoglobin A1c ( HbA1c ) at 26 weeks .


This 52-week double-blind study randomized patients to subcutaneous dulaglutide 1.5 mg , dulaglutide 0.75 mg , or metformin .


Patients ( N = 807 ) had HbA1c 6.5 % ( 48 mmol/mol ) and 9.5 % ( 80 mmol/mol ) with diet and exercise alone or low-dose oral antihyperglycemic medication ( OAM ) monotherapy ; OAMs were discontinued at beginning of lead-in period .


At 26 weeks , changes from baseline HbA1c ( least squares [ LS ] mean SE ) were : dulaglutide 1.5 mg , -0.78 0.06 % ( -8.5 0.70 mmol/mol ) ; dulaglutide 0.75 mg , -0.71 0.06 % ( -7.8 0.70 mmol/mol ) ; and metformin , -0.56 0.06 % ( -6.1 0.70 mmol/mol ) .


Dulaglutide 1.5 and 0.75 mg were superior to metformin ( LS mean difference ) : -0.22 % ( -2.4 mmol/mol ) and -0.15 % ( -1.6 mmol/mol ) ( one-sided P < 0.025 , both comparisons ) , respectively .


Greater percentages reached HbA1c targets < 7.0 % ( < 53 mmol/mol ) and 6.5 % ( 48 mmol/mol ) with dulaglutide 1.5 and 0.75 mg compared with metformin ( P < 0.05 , all comparisons ) .


No severe hypoglycemia was reported .


Compared with metformin , decrease in weight was similar with dulaglutide 1.5 mg and smaller with dulaglutide 0.75 mg .