The Dual Antiplatelet Therapy Study is large streamlined clinical trial designed to evaluate antiplatelet treatment strategies in a broadly inclusive population of subjects treated with coronary stents .


Whether large streamlined trials can successfully include a representative group of study sites and patients has not been formally assessed .


Within the National Cardiovascular Data Registry CathPCI Registry , we compared characteristics and outcomes of hospitals participating versus not participating in the Dual Antiplatelet Therapy Study .


We also compared clinical and procedural characteristics of trial subjects undergoing percutaneous coronary intervention ( PCI ) with drug-eluting stents to contemporaneous patients within the National Cardiovascular Data Registry CathPCI Registry .


Standardized differences between groups were estimated .


Between September 2009 and July 2011 , 1.1 million PCIs were performed among 1276 hospitals , of which 309 ( 24.2 % ) participated in the Dual Antiplatelet Therapy Study .


Participating hospitals were larger ( 468 versus 311 beds ) , more frequently located in urban settings ( 61.2 % versus 42.6 % ) , and had higher annual PCI volumes ( 858 versus 378 ) compared with nonparticipating hospitals , although hospital case mix and procedural outcomes were similar .


Compared with CathPCI patients , trial patients undergoing PCI with drug-eluting stents were similar with respect to race , sex , and rates of diabetes mellitus , hypertension , and smoking , although they had lower rates of prior cardiovascular disease .


Within the Dual Antiplatelet Therapy Study , clinical trial sites had similar patient case mix and clinical outcomes as nonparticipating sites .


Although trial participants were representative of PCI patients with respect to race , sex and most comorbidities , they had a lower prevalence of chronic cardiovascular disease compared with registry patients .


Although a streamlined cardiovascular clinical trial may successfully involve a large number of hospitals and rapidly enroll a diverse population of patients , differences between eligible patients and those actually enrolled remained .


http://www.clinicaltrials.gov .


Unique identifier : NCT00977938 .


To evaluate the safety and feasibility of the da Vinci Surgical System in transoral robotic-assisted surgery for benign indications .


A multicenter , single-arm , retrospective case series .


Perioperative outcomes were recorded for patients presenting with obstructive sleep apnea , airway obstruction , lingual tonsillar/tonsillar/tongue base hypertrophy , or dysphagia who underwent one or more transoral procedures , including lingual tonsillectomy and tongue base resection ( partial glossectomy ) at one of three US institutions .


Between January 2010 and October 2013 , 285 patients ( age 51.5 years , body mass index 30.5 kg/m ( 2 ) ) underwent 293 procedures .


No conversions or blood transfusions were needed .


The average operative time was 86.7 minutes , and the average volume of tissue resected ( lingual tonsil and tongue base ) was 8.3 mL .


Hospital stays averaged 1.8 days , and the postoperative complication rate was 20.7 % .


There were no complications specifically related to the use the da Vinci Surgical System , and none of the complications were life threatening .


These results demonstrate that it is safe and feasible to use the da Vinci Surgical System to perform lingual tonsillectomy and base of tongue resection ( partial glossectomy ) procedures for benign indications .


The aim of this study was to investigate the efficacy of dezocine ( DEZ ) versus placebo control ( CON ) and 2 % lidocaine ( LID ) in prevention of injection pain due to DEZ .


A prospective randomized double-blind , placebo-CON study was conducted in 75 adults , American Society of Anesthesiologists physical status I or II , scheduled to undergo an elective surgery .


A total of 25 patients were randomly assigned to one of the three groups , thus CON , group LID and group DEZ .


The groups received either 2 ml of normal saline or 2 ml 2 % LID or 2 mg/2 ml DEZ , respectively , as pre-treatment .


Propofol was injected 1 min later .


A blinded researcher assessed the patient 's pain level using a four point verbal rating scale .


Less patients experienced pain due to propofol injection in the LID ( 40 % ) and DEZ ( 28 % ) groups compared with the CON ( 84 % ) group ( P < 0.05 ) .


Six patients ( 24 % ) in the CON group reported severe pain during propofol injection but none in the other two groups .


Pre-treatment with DEZ decreases propofol injection pain as effectively as LID .


For most older women with early breast cancer , standard treatment after breast-conserving surgery is adjuvant whole-breast radiotherapy and adjuvant endocrine treatment .


We aimed to assess the effect omission of whole-breast radiotherapy would have on local control in older women at low risk of local recurrence at 5 years .


Between April 16 , 2003 , and Dec 22 , 2009 , 1326 women aged 65 years or older with early breast cancer judged low-risk ( ie , hormone receptor-positive , axillary node-negative , T1-T2 up to 3 cm at the longest dimension , and clear margins ; grade 3 tumour histology or lymphovascular invasion , but not both , were permitted ) , who had had breast-conserving surgery and were receiving adjuvant endocrine treatment , were recruited into a phase 3 randomised controlled trial at 76 centres in four countries .


Eligible patients were randomly assigned to either whole-breast radiotherapy ( 40-50 Gy in 15-25 fractions ) or no radiotherapy by computer-generated permuted block randomisation , stratified by centre , with a block size of four .


The primary endpoint was ipsilateral breast tumour recurrence .


Follow-up continues and will end at the 10-year anniversary of the last randomised patient .


Analyses were done by intention to treat .


The trial is registered on ISRCTN.com , number ISRCTN95889329 .


658 women who had undergone breast-conserving surgery and who were receiving adjuvant endocrine treatment were randomly assigned to receive whole-breast irradiation and 668 were allocated to no further treatment .


After median follow-up of 5 years ( IQR 384-605 ) , ipsilateral breast tumour recurrence was 13 % ( 95 % CI 02-23 ; n = 5 ) in women assigned to whole-breast radiotherapy and 41 % ( 24-57 ; n = 26 ) in those assigned no radiotherapy ( p = 00002 ) .


Compared with women allocated to whole-breast radiotherapy , the univariate hazard ratio for ipsilateral breast tumour recurrence in women assigned to no radiotherapy was 519 ( 95 % CI 199-1352 ; p = 00007 ) .


No differences in regional recurrence , distant metastases , contralateral breast cancers , or new breast cancers were noted between groups .


5-year overall survival was 939 % ( 95 % CI 918-960 ) in both groups ( p = 034 ) .


89 women died ; eight of 49 patients allocated to no radiotherapy and four of 40 assigned to radiotherapy died from breast cancer .


Postoperative whole-breast radiotherapy after breast-conserving surgery and adjuvant endocrine treatment resulted in a significant but modest reduction in local recurrence for women aged 65 years or older with early breast cancer 5 years after randomisation .


However , the 5-year rate of ipsilateral breast tumour recurrence is probably low enough for omission of radiotherapy to be considered for some patients .


Chief Scientist Office ( Scottish Government ) , Breast Cancer Institute ( Western General Hospital , Edinburgh ) .


To explore the impact and effect mechanism of electroacupuncture ( EA ) on oocyte quali ty in the patients with infertility of kidney deficiency pattern .


Sixty-six cases differentiated as kidney de ficiency and with in vitro fertilization-embryo transplantation ( IVF-ET ) , aged fromnt 35 to 42 years were rando - mized into an observation group and a control group , 33 cases in each one .


The IVF-ET therapy of the long proto - col with gonadotrophin releasing hormone agonist was adopted in the two groups .


In the observation group .


on the 5th day of menstruation in IVF cycle , EA was applied to Sanyinjiao ( SP 6 ) .


Zigong ( EX CA 1 ) , Zhongji ( CV 3 ) and Guanyuan ( CV 4 ) .


In the control group , the sham-acupuncture was applied to the same acupoints .


The treatment was given once every two days till the date of egg collection and the needles were retained for 30 min each time .


The change in the score of kidney deficiency syndrome , the high-quality oocyte rate , the high-quality embryo rate and clinical pregnant rate were observed in the two groups .


The levels of insulin-like growth factor-i ( IGF-1 ) and IGF-2 in follicular fluid and the serum - endorphin - EP ) on the date of egg collection and the correlation with oocyte quality were compared bIetween the two groups .


1 ) In the observation group , the kidney deficiency syndrome score after treatment was reduced apparently as compared with that before treatment ( P < 0.05 ) , the score after treatment in the observation group was reduced much more apparently as compared with the control group ( P < 0.05 ) .


2 ) The high-quality egg rate and the high-quality embryo rate in the observation group were both higher than those in the control group [ 81.3 % ( 161/198 ) vs 57.6 % ( 98/170 ) , 59.8 % ( 58/97 ) vs 37.7 % ( 26/69 ) , both P < 0.05 ] .


3 ) Compared with the control group .


the levels of IGF-1 and IGF-2 in follicular fluid and serum - EP on the day of egg collection were all increased obviously in the observation group ( all P < 0.05 ) .


4 ) The levels of IGF-1 and IGF-2 in follicular fluid and serum - EP presented the linear positive correlation with the high-quality egg rate .


EA effectively improves the expressions of IGF in follicular fluid and serum - EP , increases the high-quality egg rate and high-quality embryo rate and relieves the symptoms of kidney deficiency .


The aim of this work was to evaluate the effect of long term supplementation with two moderate dose of Zn on plasma and cellular red-ox status markers in elderly volunteers .


In a double blind study 108 healthy volunteers , aged 70-85 years , were enrolled .


They were randomly divided in 3 groups of treatment , receiving placebo , 15 mg/day and 30 mg/day of Zn for 6 months .


Red-ox status markers were assessed at baseline and after 6 months evaluating carotenoids , vitamin A and E in plasma ; glutathione ( GSH ) , thiol groups ( RSH ) , malondialdehyde ( MDA ) , percentage of haemolysis and methemoglobin in erythrocytes .


Zn supplementation had no significant effects on red-ox status markers except for vitamin A levels ( from 1.940.44 to 2.180.48 M in volunteers receiving 15 mg of Zn and from 1.950.46 to 2.260.56 M in volunteers receiving 30 mg of Zn ) , which increased proportionally to zinc dose .


It appears that , differently from unhealthy populations , long-term supplementation with two moderate doses of Zn in a healthy elderly population , with an adequate Zn nutritive status and macro and micronutrients intakes in the range of normality , is an inefficient way to increase antioxidant defences .


This study extends previous work on longitudinal patterns of spousal associations between functional impairments and psychological well-being in older couples in 3 important ways : By examining Mexican Americans , by considering a broader range of functional limitations , and by assessing the role of health status , social integration , and socioeconomic resources in these associations .


Drawing on data from 6 waves of the Hispanic Established Population for the Epidemiologic Study of the Elderly ( 1993-2007 ) , we employed growth curve models to investigate the implications of the spouse 's functional limitations for the respondent 's age trajectories of depressive symptoms in older Mexican American couples .


Models were run separately for husbands and wives .


The spouse 's functional limitations were associated with higher levels of depressive symptoms in the respondent .


Personal resources can both ameliorate and intensify the adverse implications of the spouse 's functional limitations for the respondent 's depressive symptomatology .


The interplay among these factors can vary by gender and the type of the spouse 's functional impairment .


Future studies would benefit by examining caregiving patterns in older couples , by distinguishing between different dimensions of social support available to them , and by considering changes in couples ' marital quality and social ties over time .


Interleukin-1 ( IL-1 ) is a key mediator of ischaemic brain injury induced by stroke and subarachnoid haemorrhage ( SAH ) .


IL-1 receptor antagonist ( IL-1Ra ) limits brain injury in experimental stroke and reduces plasma inflammatory mediators associated with poor outcome in ischaemic stroke patients .


Intravenous ( IV ) IL-1Ra crosses the blood-brain barrier ( BBB ) in patients with SAH , to achieve cerebrospinal fluid ( CSF ) concentrations that are neuroprotective in rats .


A small phase II , double-blind , randomised controlled study was carried out across two UK neurosurgical centres with the aim of recruiting 32 patients .


Adult patients with aneurysmal SAH , requiring external ventricular drainage ( EVD ) within 72 hours of ictus , were eligible .


Patients were randomised to receive IL-1Ra ( 500 mg bolus , then a 10 mg/kg/hr infusion for 24 hours ) or placebo .


Serial samples of CSF and plasma were taken and analysed for inflammatory mediators , with change in CSF IL-6 between 6 and 24 hours as the primary outcome measure .


Six patients received IL-1Ra and seven received placebo .


Concentrations of IL-6 in CSF and plasma were reduced by one standard deviation in the IL-1Ra group compared to the placebo group , between 6 and 24 hours , as predicted by the power calculation .


This did not reach statistical significance ( P = 0.08 and P = 0.06 , respectively ) , since recruitment did not reach the target figure of 32 .


No adverse or serious adverse events reported were attributable to IL-1Ra .


IL-1Ra appears safe in SAH patients .


The concentration of IL-6 was lowered to the degree expected , in both CSF and plasma for patients treated with IL-1Ra .


Perioperative supplemental oxygen has been proposed to decrease the incidence of surgical site infection ( SSI ) in colorectal surgery with controversial results .


We have assessed the influence of hyperoxygenation on SSI by using the most homogeneous study population .


We studied , in a prospective randomized study , 81 patients , who underwent elective open infraperitoneal anastomosis for rectal cancer .


Patients were assigned randomly to an oxygen/air mixture with a fraction of inspired oxygen ( FiO2 ) of 30 % ( n = 41 ) or 80 % ( n = 40 ) .


Administration was commenced after induction of anesthesia and maintained for 6hours after surgery .


The overall wound infection rate was 21 % : 11 patients ( 26.8 % ) had wound infections in the 30 % FiO2 group and 6 ( 15 % ) in the 80 % FiO2 group ( P < .05 ) .


The risk of SSI was 41 % lower in the 80 % FiO2 group .


Supplemental 80 % FiO2 reduced postoperative SSI with few risks to the patient and little associated cost .


Early goal-directed therapy refers to the use of predefined hemodynamic goals to optimize tissue oxygen delivery in critically ill patients .


Its application in high-risk abdominal surgery is , however , hindered by safety concerns and practical limitations of perioperative hemodynamic monitoring .


Arterial waveform analysis provides an easy , minimally invasive alternative to conventional monitoring techniques , and could be valuable in early goal-directed strategies .


We therefore investigate the effects of early goal-directed therapy using arterial waveform analysis on complications , quality of life and healthcare costs after high-risk abdominal surgery .


In this multicenter , randomized , controlled superiority trial , 542 patients scheduled for elective , high-risk abdominal surgery will be included .


Patients are allocated to standard care ( control group ) or early goal-directed therapy ( intervention group ) using a randomization procedure stratified by center and type of surgery .


In the control group , standard perioperative hemodynamic monitoring is applied .


In the intervention group , early goal-directed therapy is added to standard care , based on continuous monitoring of cardiac output with arterial waveform analysis .


A treatment algorithm is used as guidance for fluid and inotropic therapy to maintain cardiac output above a preset , age-dependent target value .


The primary outcome measure is a combined endpoint of major complications in the first 30 days after the operation , including mortality .


Secondary endpoints are length of stay in the hospital , length of stay in the intensive care or post-anesthesia care unit , the number of minor complications , quality of life , cost-effectiveness and one-year mortality and morbidity .


Before the start of the study , hemodynamic optimization by early goal-directed therapy with arterial waveform analysis had only been investigated in small , single-center studies , including minor complications as primary endpoint .


Moreover , these studies did not include quality of life , healthcare costs , and long-term outcome in their analysis .


As a result , the definitive role of arterial waveform analysis in the perioperative hemodynamic assessment and care for high-risk surgical patients is unknown , which gave rise to the present trial .


Patient inclusion started in May 2012 and is expected to end in 2016 .


This trial was registered in the Dutch Trial Register ( registration number NTR3380 ) on 3 April 2012 .


To investigate the QT/QTc effects of orally administered moxifloxacin in healthy Chinese volunteers .


This was a single-blinded , randomized , single-dose , placebo-controlled , two-period cross-over study .


A total of 24 healthy Chinese volunteers were enrolled , randomly assigned to two groups : one group received moxifloxacin ( 400 mg , po ) followed by placebo with a 7-d interval , another group received placebo followed by moxifloxacin with a 7-d interval .


On the days of dosing , 12-lead 24 h Holter ECGs were recorded and evaluated by an ECG laboratory blind to the treatments .


Blood samples were collected to determine plasma concentrations of moxifloxacin .


The orally administered moxifloxacin significantly prolonged the mean QTc at all time points except 0.5 h post-dose .


The largest time-matched difference in the QTcI was 8.35 ms ( 90 % CI : 5.43 , 11.27 ) at 4 h post-dose .


The peak effect on QTcF was 9.35 ms ( 90 % CI : 6.36 , 12.34 ) at 3 h post-dose .


A pharmacokinetic-QTc model suggested a 2.084 ms increase in the QTc interval for every 1000 ng/mL increase in plasma concentration of moxifloxacin .


In addition , the orally administered moxifloxacin was well tolerated by the subjects .


Orally administered moxifloxacin significantly prolongs QTc , which supports its use as a positive control in ICH-E14 TQT studies in Chinese volunteers .


Cold atmospheric plasma ( CAP , i.e. ionized air ) is an innovating promising tool in reducing bacteria .


We conducted the first clinical trial with the novel PlasmaDerm VU-2010 device to assess safety and , as secondary endpoints , efficacy and applicability of 45 s/cm ( 2 ) cold atmospheric plasma as add-on therapy against chronic venous leg ulcers .


From April 2011 to April 2012 , 14 patients were randomized to receive standardized modern wound care ( n = 7 ) or plasma in addition to standard care ( n = 7 ) 3 per week for 8 weeks .


The ulcer size was determined weekly ( Visitrak , photodocumentation ) .


Bacterial load ( bacterial swabs , contact agar plates ) and pain during and between treatments ( visual analogue scales ) were assessed .


Patients and doctors rated the applicability of plasma ( questionnaires ) .


The plasma treatment was safe with 2 SAEs and 77 AEs approximately equally distributed among both groups ( P = 0.77 and P = 1.0 , Fisher 's exact test ) .


Two AEs probably related to plasma .


Plasma treatment resulted in a significant reduction in lesional bacterial load ( P = 0.04 , Wilcoxon signed-rank test ) .


A more than 50 % ulcer size reduction was noted in 5/7 and 4/7 patients in the standard and plasma groups , respectively , and a greater size reduction occurred in the plasma group ( plasma -5.3 cm ( 2 ) , standard : -3.4 cm ( 2 ) ) ( non-significant , P = 0.42 , log-rank test ) .


The only ulcer that closed after 7 weeks received plasma .


Patients in the plasma group quoted less pain compared to the control group .


The plasma applicability was not rated inferior to standard wound care ( P = 0.94 , Wilcoxon-Mann-Whitney test ) .


Physicians would recommend ( P = 0.06 , Wilcoxon-Mann-Whitney test ) or repeat ( P = 0.08 , Wilcoxon-Mann-Whitney test ) plasma treatment by trend .


Cold atmospheric plasma displays favourable antibacterial effects .


We demonstrated that plasma treatment with the PlasmaDerm VU-2010 device is safe and effective in patients with chronic venous leg ulcers .


Thus , larger controlled trials and the development of devices with larger application surfaces are warranted .


RT002 is a new injectable BoNTA product .


This formulation limits the spread of BoNTA , potentially permitting safe administration of larger doses and possibly extending its duration of action .


This phase 1/2 clinical study was designed to establish the safety of RT002 for the treatment of moderate-to-severe glabellar lines .


Subjects were randomized into four groups ( N = 12/group ) .


Cohorts 1-3 received escalating doses of RT002 ranging from half the equivalent dose of approved toxins up to twice the current dose levels .


The safety of each dose was confirmed prior to administering the next dose .


Subjects in Cohort 4 were treated with the highest dose and observed for 36 weeks or until GLSS returned to baseline .


All doses of RT002 were well-tolerated .


Common AEs were headache and mild injection site reactions .


At Week 4 , all doses of RT002 were highly effective at maximum frown .


Cohort 4 achieved 7 month median duration .


At 6 months , 80 % of subjects maintained a 1-point improvement in Investigator GLSS and 60 % maintained WSS of None or Mild .


Study limitations include an open-label design and modest number of subjects .


RT002 is a safe and effective BoNTA product with an extended duration of action .


To compare the clinical pregnancy rates in women who underwent fresh embryo transfer ( ET ) with and without one acupuncture session before and after the transfer using a modified Paulus protocol .


The prospective , physician-blinded study randomized 113 women to either no intervention ( n = 56 ) or acupuncture performed off-site ( n = 57 ) .


Secondary outcomes were positive pregnancy test and live birth rates .


Intent-to-treat analysis and per protocol analysis were performed .


No difference in age and in vitro fertilization-embryo transfer ( IVF-ET ) parameters were detected .


Compared to the control group , the treatment group had a lower pregnancy rate ( 43.6 % vs. 64.8 % , p = 0.045 ) .


More women in the control group had live births than did those in the acupuncture group ( 56.0 % vs. 36.0 % , respectively , p = 0.033 ) .


Generalized mixed models revealed that patients who received acupuncture had lower odds of clinical pregnancy than those who did not undergo acupuncture treatment ( OR = 0.42 , 95 % CI 0.19-0 .93 ) .


Our study found that acupuncture performed off-site on the day of ET was detrimental to the success of the transfer .


More research is needed with a greater number of subjects to elucidate the role of acupuncture before and after ET , ideal treatment frequency , and to further explore the role of individualized acupuncture treatment on IVF-ET pregnancy rates .


The energy intake necessary to maintain weight and body composition is called the energy requirement for weight maintenance and can be determined by using the doubly labeled water ( DLW ) method .


The objective was to determine the energy requirements of nonobese men and women in the Comprehensive Assessment of Long-Term Effects of Reducing Intake of Energy 2 study .


Energy requirements were determined for 217 healthy , weight-stable men and women [ aged > 21 to < 50 y ; 70 % female , 77 % white ; body mass index ( BMI ; in kg/m ( 2 ) ) 22 to < 28 ; 52 % overweight ] over 28 d with 2 consecutive 14-d DLW assessments in addition to serial measures of body weight and fat-free mass and fat mass by dual-energy X-ray absorptiometry .


Energy intake and physical activity were also estimated by self-report over 6 consecutive d in each DLW period .


Total daily energy expenditure ( TDEE ) was consistent between the 2 DLW studies ( TDEE1 : 2422 404 kcal/d ; TDEE2 : 2465 408 kcal/d ; intraclass correlation coefficient = 0.90 ) with a mean TDEE of 2443 397 kcal/d that was , on average , 20 % ( 580 kcal/d ) higher in men than in women ( P < 0.0001 ) .


The regression equation relating mean TDEE to demographics and weight was as follows : TDEE ( kcal/d ) = 1279 + 18.3 ( weight , kg ) + 2.3 ( age , y ) - 338 ( sex : 1 = female , 0 = male ) ; R ( 2 ) = 0.57 .


When body composition was included , TDEE ( kcal/d ) = 454 + 38.7 ( fat-free mass , kg ) - 5.4 ( fat mass , kg ) + 4.7 ( age in y ) + 103 ( sex : 1 = female , 0 = male ) ; R ( 2 ) = 0.65 .


Individuals significantly underreported energy intake ( 350 kcal/d ; 15 % ) , and underreporting by overweight individuals ( ~ 400 kcal/d ; 16 % ) was greater ( P < 0.001 ) than that of normal-weight individuals ( ~ 270 kcal/d ; 12 % ) .


Estimates of TDEE from a 7-d physical activity recall and measured resting metabolic rate also suggested that individuals significantly underreported physical activity ( ~ 400 kcal/d ; 17 % ; P < 0.0001 ) .


These new equations derived over 1 mo during weight stability can be used to estimate the free-living caloric requirements of nonobese adults .


This trial was registered at clinicaltrials.gov as NCT00427193 .


To investigate the effect of vacuum drainage on blood circulation of expanded skin flap , so as to confirm suitable negative pressure for ear reconstruction .


21 patients ( Auricular Reconstructive Center of Plastic Surgery Hospital , PUMC ) were randomly divided into A , B , C 3 groups to receive vacuum drainage of : -20 , -40 and -60 kPa , respectively .


The length and width of reconstructed ears , which represented the swelling degree , were measured instantly and 5 , 10 days postoperatively .


The changes were calculated and reflected venous drainage of flaps .


The temperature of proximal ( concha ) and distal ( helix ) part of the expanded flaps , which represented the arterial blood supply of flaps , was detected by infrared thermography after operation .


Five days after operation [ ( 1.48 + / - 0.47 ) mm , ( 0.36 + / - 0.06 ) mm ] and immediately [ ( 1.67 + / - 0.69 ) mm , ( 0.40 + / - 0.16 ) mm ) ] , the changes of the length and width of reconstructed ear in group B was significantly low , while there was no statistically difference between group A and C ( P > 0.05 ) .


The data between 10 days and 5 days after operation showed the same result .


Along with the increase of the negative pressure , the swelling degree of reconstructed ears decreased firstly and then increased reversely ( P < 0.01 ) .


The flap temperature of reconstructed ears increased ( P < 0.01 ) , especially in proximal ( concha ) part ( P < 0.01 ) , when the negative pressure increased ( 0 to -60 kPa ) .


Vacuum drainage has effect on both the venous drainage and blood supply .


Negative pressure of -40 kPa can improve both the blood supply and venous drainage .


It should be as reference for clinical application .


Recent data suggest the possible benefits of - tocopherol and - carotene supplementation on liver cancer and chronic liver disease ( CLD ) , but the long-term trial data are limited .


We evaluated the efficacy of supplemental 50mgday ( -1 ) - tocopherol and 20mgday ( -1 ) - carotene on incident liver cancer and CLD mortality in a randomised trial of 29,105 Finnish male smokers , who received supplementation for 5-8 years and were followed for 16 additional years for outcomes .


Supplemental - tocopherol , - carotene , or both , relative to placebo , did not reduce the risk of liver cancer or CLD , either overall , during the intervention or during the post-intervention period .


Long-term supplemental - tocopherol or - carotene had no effect on liver cancer or CLD mortality over 24 years of follow-up .


The analgesic efficacy of sciatic nerve block ( SNB ) after total knee arthroplasty ( TKA ) is unclear .


Proximal and distal SNB are each reported to provide posterior knee analgesia , whereas others suggest that posterior knee pain is not important after TKA .


This prospective , randomized , double-blind , parallel-arm , placebo-controlled trial examined whether proximal or distal SNB provides superior analgesia in the posterior knee compared with no SNB after TKA .


Sixty patients undergoing TKA were randomized to single-shot SNB using either the infragluteal ( Proximal group ) or popliteal ( Distal group ) technique , or no SNB ( Placebo group ) .


All patients received spinal anesthesia and continuous-femoral nerve blockade .


A blinded observer assessed posterior and anterior knee pain at 2 , 4 , 6 , 8 , 12 , and 24 h postoperatively .


The primary outcome was moderate-to-severe posterior knee pain at 4 h postoperatively ; secondary outcomes included SNB procedural time , needle passes , and discomfort .


Fifty-three patients were analyzed .


The proportion of patients ( Proximal : Distal : Placebo ) who experienced moderate-to-severe posterior knee pain was 18 % :22 % :89 % ( P < 0.00001 ) at 2 h , 24 % :28 % :72 % ( P < 0.01 ) at 4 h , and 12 % :17 % :78 % ( P = 0.00003 ) at 6 h postoperatively .


For the anterior knee , the proportion of patients reporting moderate-to-severe pain was 6 % :11 % :44 % ( P = 0.02 ) at 2 h , 6 % :6 % :39 % ( P = 0.012 ) at 4 h , and 12 % :6 % :44 % ( P = 0.017 ) at 6 h postoperatively .


Moderate-to-severe pain did not differ between groups beyond 6 h. Both proximal and distal SNB reduced rest pain in the posterior and anterior knee up to 8 h postoperatively compared with no SNB .


The popliteal technique required shorter procedural time , fewer needle passes , and produced less discomfort .


Proximal and distal SNB each reduce posterior and anterior knee pain after TKA compared with no SNB .


The aim of this study was to determine the role of omega-3 supplementation on NEFA concentration , insulin sensitivity and resistance , and glucose and lipid metabolism in type 2 diabetic patients .


Forty-four type 2 diabetic patients were randomly recruited into two groups .


Group A received 4 g/day omega-3 soft gels , and group B received a placebo for 10 wks .


Blood samples were collected after 12-h fast .


Physical activity records , three-day food records , and anthropometric measurements were obtained from all participants at the beginning and end of the study .


Omega-3 supplementation caused a significant reduction in NEFA in the intervention group compared with the placebo group ( P = 0.009 ) .


Additionally , the administration of omega-3 resulted in significantly greater changes ( Diff ) for the intervention group in various parameters , such as insulin and Quicki indices compared with the placebo group ( P < 0.05 ) .


Omega-3 fatty acid supplementation in type 2 diabetic patients improved insulin sensitivity , probably due to the decrease in NEFA concentrations .


The interleukin-6 receptor ( IL-6R ) blocker tocilizumab ( TCZ ) reduces inflammatory disease activity in rheumatoid arthritis ( RA ) but elevates lipid concentrations in some patients .


We aimed to characterise the impact of IL-6R inhibition on established and novel risk factors in active RA .


Randomised , multicentre , two-part , phase III trial ( 24-week double-blind , 80-week open-label ) , MEASURE , evaluated lipid and lipoprotein levels , high-density lipoprotein ( HDL ) particle composition , markers of coagulation , thrombosis and vascular function by pulse wave velocity ( PWV ) in 132 patients with RA who received TCZ or placebo .


Median total-cholesterol , low-density lipoprotein-cholesterol ( LDL-C ) and triglyceride levels increased in TCZ versus placebo recipients by week 12 ( 12.6 % vs 1.7 % , 28.1 % vs 2.2 % , 10.6 % vs -1.9 % , respectively ; all p < 0.01 ) .


There were no significant differences in mean small LDL , mean oxidised LDL or total HDL-C concentrations .


However , HDL-associated serum amyloid A content decreased in TCZ recipients .


TCZ also induced reductions ( > 30 % ) in secretory phospholipase A2-IIA , lipoprotein ( a ) , fibrinogen and D-dimers and elevation of paraoxonase ( all p < 0.0001 vs placebo ) .


The ApoB/ApoA1 ratio remained stable over time in both groups .


PWV decreases were greater with placebo than TCZ at 12weeks ( adjusted mean difference 0.79 m/s ( 95 % CI 0.22 to 1.35 ; p = 0.0067 ) ) .


These data provide the first detailed evidence for the modulation of lipoprotein particles and other surrogates of vascular risk with IL-6R inhibition .


When compared with placebo , TCZ induced elevations in LDL-C but altered HDL particles towards an anti-inflammatory composition and favourably modified most , but not all , measured vascular risk surrogates .


The net effect of such changes for cardiovascular risk requires determination .


in the treatment of early osteoartrosis , analgesics and non-steroidal anti-inflammatory drugs are frequently used to relieve pain .


Currently , platelet rich plasma is used as an alternative in the treatment of osteoartrosis .


The aim of this study was to evaluate the effect of platelet rich plasma compared to paracetamol as a treatment for patients with knee osteoartrosis grade I.


we evaluated 42 patients who were randomized into two groups .


Group one was treated with 5 mL of platelet rich plasma in two applications , while group two was treated with 1 gr of oral paracetamol every 8 hours for 30 days .


Both patient groups received supervised physical rehabilitation during the 6 month observation period .


Peripheral blood samples were taken to measure plasma IL-1 , TNF-a and TGF-1 levels at day 0 and at 6 months post-treatment .


Clinical evaluation was conducted using the KOOS at the start of the study and for every subsequent month during the study period .


the Knee injury and Osteoarthritis Outcome Score ( KOOS ) for group one at the start of the treatment was measured at 30.1 points , whereas at the end , it was measured at 48.2 points , showing a clinical improvement of 60 % .


There were no statistically significant differences in IL-1 and TNF-a levels between groups treated either with platelet rich plasma or paracetamol .


Our patients treated with platelet rich plasma showed a statistically significant increase in the serum levels of TGF-1 , which was associated with an improvement in the clinical evaluation used ( KOOS ) .


High Frequency electrical Stimulation ( HFS ) of the skin induces enhanced brain responsiveness expressed as enhanced Event-Related Potential ( ERP ) N1 amplitude to stimuli applied to the surrounding unconditioned skin in healthy volunteers .


The aim of the present study was to investigate whether this enhanced ERP N1 amplitude could be a potential marker for altered cortical sensory processing in patients with persistent pain after surgery .


Nineteen male patients ; 9 with and 10 without persistent pain after inguinal hernia repair received HFS .


Before , directly after and thirty minutes after HFS evoked potentials and the subjective pain intensity were measured in response to electric pain stimuli applied to the surrounding unconditioned skin .


The results show that , thirty minutes after HFS , the ERP N1 amplitude observed at the conditioned arm was statistically significantly larger than the amplitude at the control arm across all patients .


No statistically significant differences were observed regarding ERP N1 amplitude between patients with and without persistent pain .


However , thirty minutes after HFS we did observe statistically significant differences of P2 amplitude at the conditioned arm between the two groups .


The P2 amplitude decreased in comparison to baseline in the group of patients with pain .


The ERP N1 effect , induced after HFS , was not different between patients with vs. without persistent pain .


The decreasing P2 amplitude was not observed in the patients without pain and also not in the previous healthy volunteer study and thus might be a marker for altered cortical sensory processing in patients with persistent pain after surgery .


Pilsicainide hydrochloride is a class IC antiarrhythmic agent used for the treatment of supraventricular and ventricular arrhythmias and atrial fibrillation .


The objective of the present study was to determine the pharmacokinetics ( PK ) of a pilsicainide hydrochloride injection in healthy Chinese adults .


The study was conducted to meet China State Food and Drug Administration requirements for the marketing of the new generic formulation of pilsicainide hydrochloride .


This Phase I , randomized , parallel-group , open-label , single-dose PK study was conducted in healthy Chinese volunteers .


Subjects were randomized to receive a single dose of 0.25 - , 0.50 - , and 0.75-mg / kg pilsicainide hydrochloride with a 10-minute intravenous infusion .


Serial blood and urine samples were collected up to 24 hours after dosing ; drug concentrations in plasma and urine were then determined by using LC-MS/MS .


The PK parameters of pilsicainide were calculated from the plasma concentration-time data according to noncompartmental methods .


Safety profile was evaluated by monitoring adverse events , clinical laboratory parameters , and the results of 12-lead ECGs .


Thirty healthy volunteers ( mean [ SD ] age , 28.0 [ 4.95 ] years ; weight , 59.3 [ 6.51 ] kg ; height , 165.0 [ 7.25 ] cm ; body mass index , 21.7 [ 1.94 ] kg/m ( 2 ) ) were randomly divided into 3 groups , each consisting of 5 men and 5 women .


After single-dose intravenous administration of 0.25 , 0.50 , and 0.75 mg/kg of pilsicainide hydrochloride , mean Cmax was 0.34 ( 0.11 ) , 0.54 ( 0.15 ) , and 1.05 ( 0.19 ) g/mL , respectively ; AUC0-24 was 0.76 ( 0.12 ) , 1.61 ( 0.37 ) , and 2.61 ( 0.46 ) h g/mL ; and AUC0 - was 0.79 ( 0.13 ) , 1.71 ( 0.46 ) , and 2.72 ( 0.50 ) h g/mL .


The ranges for tz , CL , and Vz were 5.19 to 5.98 hours , 4.73 to 5.44 mL/min/kg , and 2.23 to 0.58 L/kg , respectively .


The mean urinary recovery rate within 24 hours was 75.0 % ( 12.0 % ) , 65.0 % ( 19.2 % ) , and 66.4 % ( 14.1 % ) .


Men and women had significantly different AUC0-24 values in the 0.50-mg / kg dose group ( P = 0.044 ) , and Vz showed significant differences between men and women in all 3 dose groups ( P = 0.001 ) .


According to ECG parameters , PR intervals were significantly prolonged after administration at all 3 doses ( P = 0.034 , P < 0.001 , and P = 0.034 ) ; no significant changes were seen in QRS width , QTc interval , or other parameters .


Pilsicainide hydrochloride demonstrated linear PK , and the increase in the exposure of pilsicainide ( AUC0-24 and AUC0 - ) was dose proportional after single doses of 0.25 , 0.50 , and 0.75 mg/kg .


All 3 pilsicainide hydrochloride doses were well tolerated in these Chinese volunteers .


ChiCTR-ONC-13003546 .


Hyperthermia has long been used in combination with radiation for the treatment of cancers .


This study aimed to investigate the efficacy safety and impact on the immune function of the abdominal hyperthermia combining with radiotherapy .


Sixty-eight patients with post-operative local recurrent gastric carcinoma were divided randomly into two groups .


Patients in 3DCRT + HT group received three-dimensional conformal radio therapy combined with abdominal hyperthermia while patients from 3DCRT group only received the three-dimensional conformal radiation therapy .


The differences of efficacy , toxicity and the impact on immune function between two kinds of therapies were compared .


Response rate in 3DCRT + HT group was 57.2 % , which was significant higher than that in 3DCRT group ( 47.1 % ) ( P = 0.04 ) .


Median local progression-free survival time of 3DCRT + HT group ( 14 months ) was significantly longer than 3DCRT group ( 11 months ) .


The peripheral blood T lymphocyte subsets analyses showed that , after the treatment , CD3 + , CD4 + , NK level and CD4 + / CD8 + ratio increased significantly , while there was no significant alterations for those immunological parameters in 3DCRT group .


Abdominal hyperthermia combined with three-dimensional conformal radiotherapy could gain higher response rate , prolong median local progression-free survival time and improve immune function for the post-operative recurrentgastric cancer .


To compare the respiratory and circulatory parameters between intranasal and intravenous dexmedetomidine in gastroscopy .


60 patients undergoing elective gastroscopy were randomly divided into group D1 and D2 .


Dexmedetomidine ( 0.5 g/kg , 1 mL ) and normal saline ( NS , 1 mL ) were given by intranasal route 40 minutes before induction , and then NS ( 20 mL ) and dexmedetomidine ( 0.5 g/kg , 20 mL ) were given intravenously 10 minutes before induction , respectively , in groups D1 and D2 .


Propofol ( 1.5 - 2 mg/kg ) was used for induction .


Heart rate ( HR ) , mean arterial pressure ( MAP ) , pulse oxygen saturation ( SpO ) , and respiratory rate ( RR ) were monitored .


The latent period of falling asleep , the duration of gastroscopy , the time of awakening , and the total dose of propofol consumption were also recorded .


Postoperative sedation scale and adverse reactions were observed .


One patient in group D1 was excluded from the study due to atrioventricular block .


The HR and SpO were significantly lower , but RR was significantly higher in group D2 than in group D1 ( all p < 0.05 ) .


The time of awakening was significantly longer and the rates of respiratory depression were significantly higher in group D2 than in group D1 ( all p < 0.05 ) There were no significant differences in other parameters between both groups .


Intranasal dexmedetomidine is a new , safe , and effective approach for gastroscopy because it has more stable respiratory and circulatory parameters and less adverse reactions than intravenous dexmedetomidine .


In the SELECT trial , disease activity was reduced in patients with multiple sclerosis who received daclizumab high-yield process ( HYP ) for 52 weeks .


The primary aim of the SELECTION extension study was to assess the safety and immunogenicity of extended treatment with daclizumab HYP .


A multicentre , randomised , double-blind , 52-week extension trial was done in 74 centres in the Czech Republic , Germany , Hungary , India , Poland , Russia , Ukraine , and the UK between Feb 13 , 2009 , and Oct 3 , 2012 .


Eligible patients were aged 18-55 years , had relapsing-remitting multiple sclerosis , and had completed the SELECT study .


Patients who received placebo in SELECT were randomly assigned ( 1:1 ) to receive 150 mg or 300 mg subcutaneous daclizumab HYP every 4 weeks for 52 weeks ( treatment initiation group ) ; those who had received daclizumab HYP were randomly assigned ( 1:1 ) to continue their present dose with ( washout and re-initiation group ) or without ( continuous treatment group ) a washout period of 20 weeks .


All randomisation was done with a centralised , interactive voice-response system .


Patients and personnel were masked to treatment assignment , except for the site pharmacist who prepared the study drug but had no interaction with patients .


The primary endpoints were the safety and immunogenicity of daclizumab HYP .


Analyses were by intention to treat .


This study is registered with ClinicalTrials.gov , number NCT00870740 .


517 ( 91 % ) of 567 patients who completed the SELECT trial entered SELECTION , of whom 170 were in the treatment initiation group , 173 in the continuous treatment group , and 174 in the washout and re-initiation group .


11 patients in the treatment initiation group ( 6 % ) , 13 in the continuous treatment group ( 8 % ) , and ten in the washout and re-initiation group ( 6 % ) had any serious adverse event other than relapse of multiple sclerosis .


One patient in the washout and re-initiation group ( 300 mg daclizumab HYP ) died because of autoimmune hepatitis ; a contributory role of daclizumab HYP could not be excluded .


Seven patients tested positive for neutralising antidrug antibodies : one ( 1 % ) of 128 for whom data were available in the continuous treatment group ( this patient also tested positive at SELECTION baseline ) , four ( 2 % ) in the treatment initiation group , and two ( 2 % ) of 129 in the washout and re-initiation group .


Adverse events and immunogenicity were not increased in the second year of continuous treatment with daclizumab HYP or during treatment washout and re-initiation .


These results support further assessment of daclizumab HYP for relapsing-remitting multiple sclerosis .


Biogen Idec and AbbVie Biotherapeutics .


2-Agonists are the treatment of choice for exercise-induced bronchoconstriction ( EIB ) and act through specific receptors ( ADRB2 ) .


Arg16Gly polymorphisms have been shown to affect responses to regular use of 2-agonists .


To evaluate the influence of the Arg16Gly receptor polymorphism on salmeterol bronchoprotection in EIB and assess predictors of bronchoprotection .


A prospective , genotype-blinded , randomized trial was performed in 26 subjects ( 12 Arg16Arg and 14 Gly16Gly ) with EIB who were not on controller therapy .


Subjects were administered salmeterol , 50 g twice a day for 2 weeks , and underwent an exercise challenge 9 hours after the first and last drug dose .


In addition to genotype , FEV1 , response to salmeterol , degree of EIB , and exhaled nitric oxide ( FE ( NO ) ) at baseline were examined for their association with loss of bronchoprotection ( LOB ) .


The maximum exercise-induced FEV1 fall was 27.9 1.4 % during the run-in period , 8.1 1.2 % ( 70.3 4.1 % bronchoprotection ) after the first salmeterol dose , and 22.8 3.2 % ( 18.9 11.5 % bronchoprotection ) after 2 weeks of salmeterol ( P = 0.0001 ) .


The Arg16Gly polymorphisms were not associated with the LOB in response to salmeterol .


FeNO values at baseline were significantly related to the LOB ( r = 0.47 ; P = 0.01 ) .


Mean change was a 74 13 % LOB in subjects with FE ( NO ) levels greater than 50 ppb and a 7 16 % gain in bronchoprotection in those with FE ( NO ) levels less than 25 ppb ( P = 0.01 ) .


The LOB that occurs with chronic long-acting 2-agonists use is not affected by ADRB2 Arg16Gly polymorphisms .


High FE ( NO ) was associated with marked LOB .


Use of long-acting 2-agonists before achieving a reduction in FeNO may need to be avoided .


Clinical trial registered with www.clinicaltrials.gov ( NCT 00595361 ) .


Panic disorder and agoraphobia are debilitating and frequently comorbid anxiety disorders .


A large number of patients with these conditions are treated by general practitioners in primary care .


Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety symptoms .


Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care .


The present study compares a practice team-supported , self-managed exposure programme for patients with panic disorder with or without agoraphobia in small general practices to usual care in terms of clinical efficacy and cost-effectiveness .


This is a cluster randomised controlled superiority trial with a two-arm parallel group design .


General practices represent the units of randomisation .


General practitioners recruit adult patients with panic disorder with or without agoraphobia according to the International Classification of Diseases , version 10 ( ICD-10 ) .


In the intervention group , patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner .


A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients .


In the control group , patients receive usual care from general practitioners .


Outcomes are measured at baseline ( T0 ) , at follow-up after six months ( T1 ) , and at follow-up after twelve months ( T2 ) .


The primary outcome is clinical severity of anxiety of patients as measured by the Beck Anxiety Inventory ( BAI ) .


To detect a standardised effect size of 0.35 at T1 , 222 patients from 37 general practices are included in each group .


Secondary outcomes include anxiety-related clinical parameters and health-economic costs .


Current Controlled Trials [ http://ISCRTN64669297] .


The aim of this study was to determine whether adherence to self-care modalities for breast cancer-related lymphedema ( BCRL ) predicts BCRL outcomes among 128 breast cancer survivors who participated in the 12-mo physical activity and lymphedema trial .


This was a prospective cohort study .


Adherence to ten BCRL self-care modalities , as recommended in the clinical practice guidelines for the management of BCRL , was assessed by a questionnaire at baseline .


BCRL outcomes assessed at baseline and 12 mos included volumetry , circumferences , bioimpedence spectroscopy , the Norman lymphedema survey , and therapist-defined lymphedema exacerbations requiring treatment .


Generalized linear models were used to estimate the relationship between adherence to BCRL self-care modalities and the likelihood of experiencing a BCRL outcome .


Adherence to BCRL self-care activities did not predict experiencing any BCRL outcomes at 12 mos .


Levels of adherence to BCRL self-care modalities did not predict a 5 % or greater decrease in interlimb volume ( Ptrend = 0.79 ) , 5 % or greater decrease in the sum of interlimb arm circumferences ( Ptrend = 0.47 ) , 10 % or greater decrease in bioimpedence spectroscopy ( Ptrend = 0.83 ) , 1 or greater decrease in self-reported lymphedema symptoms ( Ptrend = 0.91 ) , or therapist-defined lymphedema exacerbation requiring treatment ( Ptrend = 0.84 ) .


Our findings suggest that levels of BCRL self-care adherence do not predict BCRL outcomes among breast cancer survivors with stable lymphedema who were followed for 12 mos .


Electrocorticographic ( ECoG ) recordings from patients with medically intractable partial-onset seizures treated with a responsive neurostimulator system ( the RNS System ) that detects and stores physician-specified ECoG events provide a new data resource .


Interpretation of these recordings has not yet been validated .


The purpose was to evaluate the interrater interpretation of chronic ambulatory ECoG recordings obtained by the RNS System .


Five pairs of five experts independently classified 7,221 ECoG recordings obtained from 128 patients with medically intractable partial seizures who participated in a randomized controlled trial of the safety and efficacy of the RNS System .


ECoG detections -- `` long episodes '' or `` saturations '' -- were classified as `` seizures '' or `` not seizures '' based on a reference definition .


Interrater agreement rates and kappa score reliabilities were calculated between rater pairs from the ECoG sample as a whole and within individual patients who had more than the median number of individual ECoG recordings .


The overall interrater agreement was 79 % , with a reliability = 0.57 ( moderate agreement ) .


Agreement between pairs of reviewers ranged from 0.69 to 0.85 .


Agreement rates were 94 % or better for 50 % of patients .


Only 25 % of patients had ECoG recordings agreement rates worse than 75 % .


ECoGs with mixed interpretations ( one reviewer `` seizure '' / the other -- `` not seizure '' ) consisted of periods of low amplitude activity that evolved in amplitude or periodic discharges near 2 Hz .


Although reliability as a whole was moderate , for the majority of patients , detections yielded highly reliably interpreted events of either electrographic seizures or nonictal epileptiform activity .


To assess nurse-midwife provision of early medical termination of pregnancy ( TOP ) in a high-resource setting where ultrasound examination for dating of pregnancy is part of the protocol .


Randomised controlled equivalence trial .


Out-patient family planning unit at a university hospital .


Women seeking early medical TOP .


A total of 1180 women were randomised , without any prior examination , to counselling , examination , and treatment by either nurse-midwife or gynaecologist .


Ultrasound was performed in all cases by the allocated provider .


The primary outcome was efficacy , defined as the successful completion of TOP without need for vacuum aspiration .


Secondary outcomes were safety , defined as need for hospitalisation or blood transfusion , and acceptability , defined as preferred provider were the women to have a medical TOP in the future .


A total of 481 women in the nurse-midwife group and 457 women in the doctor group were available for the final analysis .


The effectiveness of provision of medical TOP by nurse-midwife providers was superior to that provided by doctors ( risk difference 1.6 % , 95 % confidence interval 0.2-3 .0 % , which was within the set margin of equivalence ) .


There were no significant differences in safety parameters .


Women examined and counselled by a nurse-midwife were significantly more likely ( P < 0.001 , 95 % confidence interval 0.308-0 .394 ) to prefer seeing a nurse-midwife for the consultation were they to have another medical TOP in the future .


These findings show that nurse-midwife provision of early medical TOP in a high-resource setting , where ultrasound is part of the protocol , is effective , and can be safely implemented with high acceptability among women .


To evaluate the advantageous anesthetic properties , such as the decrease of intraoperative analgesic requirement , time to extubation and recovery , and early postoperative pain , of dexmedetomidine used as hypotensive agent compared with nitroglycerin in orthognathic surgery .


The authors implemented a prospective , single-blinded , randomized clinical trial .


The sample was composed of healthy patients who were admitted for bimaxillary osteotomies and were assigned to 1 of 2 groups by a computer-generated random number and blinded to the group .


Dexmedetomidine or nitroglycerin was used as the hypotensive drug for each group .


All patients underwent hypotensive anesthesia and surgery according to standard protocol .


Intraoperative amount of fentanyl , time to eye opening , time to follow basic verbal commands , time to extubation , early postoperative pain scores , and analgesics were recorded .


Compared means were analyzed using the unpaired Student t test .


A 2-sided statistical test was used .


A P value less than .05 was considered significant .


The sample was composed of 40 participants .


The intraoperative fentanyl requirement was significantly lower in the dexmedetomidine group than in the nitroglycerin group ( 168.7556.29 and 222.5096.12 g , respectively ; P = .037 ) .


Times to eye opening and following commands were considerably longer in the dexmedetomidine group , but the time to extubation showed no meaningful difference .


Early postoperative pain after 30 and 60 minutes and the requirement for meperidine were not meaningfully different between the 2 groups .


Dexmedetomidine , used as a hypotensive drug , has anesthetic benefits compared with nitroglycerin .


Dexmedetomidine decreases the intraoperative fentanyl requirement and does not meaningfully change the time to extubation , early postoperative pain , and analgesic drug requirement .


This article aims to assess the efficacy and safety of atomoxetine in Korean adults with attention-deficit hyperactivity disorder ( ADHD ) .


This post hoc double-blind , placebo-controlled study of atomoxetine ( 40-120mg / day ) over 10 weeks in adults with ADHD at 45 Japanese , Korean , and Taiwanese study sites focused on patient data from Korea ( atomoxetine , n = 37 ; placebo , n = 37 ) .


Primary efficacy outcome was change in baseline-to-endpoint Conners ' Adult ADHD Rating Scale-Investigator-rated : Screening Version ( CAARS-Inv : SV ) Total ADHD Symptoms score .


Secondary efficacy outcomes included changes in Adult ADHD Quality of Life ( AAQoL ) total , Behavior Rating Inventory of Executive Function-Adult Version Self-Report ( BRIEF-A : Self-Report ) , and Clinical Global Impression-ADHD-Severity ( CGI-ADHD-S ) scale scores .


Atomoxetine-treated patients demonstrated a mean 18.9-point reduction in CAARS-Inv : SV total ADHD Symptoms score , compared with the 7.45-point reduction in placebo-treated patients ( P0 .01 ) .


Significantly greater improvement was found for atomoxetine versus placebo in CGI-ADHD-S ( P0 .01 ) , BRIEF-A : Self-Report global executive composite ( P0 .05 ) , and metacognition index ( P0 .01 ) executive function scores .


Nausea , decreased appetite , and dry mouth were reported with significantly greater frequency by atomoxetine-treated patients , and only one placebo-treated patient discontinued because of adverse event .


A 2.1-kg reduction in weight and a 7.5-beat / minute increase in pulse rate were observed in atomoxetine-treated patients .


These data support a significant benefit of 80 - to 120-mg once daily atomoxetine versus placebo for treatment of ADHD in adult Korean patients .


A high placebo response rate was observed in this adult Korean sample ; a higher discontinuation rate was also observed in atomoxetine-treated patients .


These observations warrant further investigation .


The present trial evaluated incorporation of bright light therapy in the treatment of chronic nonspecific back pain ( CNBP ) .


A prospective , randomized , controlled , multicenter , open design with three parallel trial arms was used .


Subjects received a novel therapeutic , an expected therapeutic ineffective low dose , or no light exposure at three different medical centers .


A total of 125 CNBP patients reporting pain intensity of 3 points on item 5 of the Brief Pain Inventory ( BPI ) were included .


Over 3 weeks , 36 active treatment , 36 placebo controls , and 33 controls received 3 or no supplementary light exposures of 5.000 lx or 230lx , respectively .


Changes in self-reported scores of pain intensity ( BPI sub-score 1 ) and depression ( Hospital Anxiety and Depression Questionnaire ) were the primary outcome measures .


Secondary outcome measures were changes in self-reported overall pain sensation ( BPI total score ) , grade of everyday life impairment ( BPI sub-score 2 ) , mood ( visual analog scale ) , and well-being ( World Health Organization-Five Well-Being Index ) .


Changes in pain intensity were higher ( 1.0 [ 0.8-1 .6 ] ) in the bright light group compared with controls ( 0.3 [ -0.1 -0.8 ] ; effect size D = 0.46 ) .


Changes in the depression score were also higher in the intervention group ( 1.5 [ 0.0-2 .5 ] ) compared with controls ( 0.0 [ 0.0-2 .0 ] ; effect size D = 0.86 ) .


No differences were seen in change scores between intervention vs sham group .


The present randomized controlled trial shows that light therapy even in low dose could improve depressive symptoms and reduce pain intensity in CNBP patients .


Further research is needed for optimizing parameters of frequency , dose , and duration of therapeutic light exposure .


Osteopathy may decrease the severity of irritable bowel syndrome ( IBS ) .


About 35 % of patients with quiescent Crohn 's disease ( CD ) continue to suffer from IBS-like symptoms with impaired quality of life ( Qol ) .


We aimed to evaluate the effect of osteopathy on the severity of IBS-like symptoms in quiescent CD patients .


We prospectively included 38 patients with CD on remission over 12 months while receiving infliximab every 8 weeks .


Patients were randomized 2/1 to receive three sessions of standardized osteopathy ( n = 25 ) at 15 , 30 , and 45 days after the last infusion of infliximab or simple follow-up .


The severity of IBS-like symptoms , psychological factors , and its impact on Qol were assessed using questionnaires .


Compared with baseline , the severity of IBS-like symptoms was significantly reduced in patients receiving osteopathy .


The decrease was significantly more pronounced in patients receiving osteopathy at day 30 [ -38.4 ( -76.1 to 10.2 ) vs. 32.2 ( -16.6 to 41.6 ) , P = 0.01 ] , day 45 [ -36.7 ( -74.4 to 25.3 ) vs. 32.2 ( -16.6 to 41.6 ) , P = 0.04 ] , and day 60 [ -39.5 ( -60.9 to -9.2 ) vs. 6.1 ( -38.7 to 28.5 ) , P = 0.05 ] with a concomitant increase in Qol ( P = 0.09 at day 30 , P = 0.02 at day 45 , P = 0.3 at day 60 ) .


Compared with baseline , the severity of fatigue was significantly reduced in patients receiving osteopathy , whereas depression and anxiety remained unchanged .


Three sessions of osteopathy reduced the severity of IBS-like symptoms associated with CD in remission .


Osteopathy should be viewed as a helpful therapeutic option to reduce the severity of abdominal pain and discomfort in patients with CD but in remission with IBS-like symptoms .


The aim of the present study was to evaluate the transverse effect of rapid maxillary expansion in patients with unilateral complete cleft lip and palate while comparing the Haas and Hyrax appliances .


The sample consisted of 48 patients divided into two groups : Group I = 25 patients treated with modified Haas appliance ( mean age : 10 years and 8 months ) ; and Group II = 23 patients treated with Hyrax appliance ( mean age : 10 years and 6 months ) .


Cast models were taken during pre-expansion and after removal of the appliance , at the end of the retention period .


The models were scanned with the aid of the 3 Shape R700 3D scanner .


Initial and final transverse distances were measured at cusp tips and cervical-palatal points of maxillary teeth by using the Ortho Analyzer 3D software .


The mean expansion obtained between cusp tips and between cervical-palatal points was , respectively : for inter-canine width , 4.80 mm and 4.35 mm with the Haas appliance and 5.91 mm and 5.91 mm with the Hyrax appliance ; as for first deciduous molars or first deciduous premolars , the values obtained were 6.46 mm and 5.90 mm in the Haas group , and 7.11 mm and 6.65 mm in the Hyrax group ; with regard to first molars , values were 6.11 mm and 5.24 mm in the Haas group , and 7.55 mm and 6.31 mm in the Hyrax group .


Rapid maxillary expansion significantly increased the transverse dimensions of the upper dental arch in patients with cleft palate , with no significant differences between the Hass and Hyrax expanders .


Two replicate randomized , placebo-controlled six-month trials ( RCTs ) and an open-label treatment extension ( OLE ) comprised the pegloticase development program in patients with gout refractory to conventional therapy .


In the RCTs , approximately 40 % of patients treated with the approved dose saw complete response ( CR ) of at least one tophus .


Here we describe the temporal course of tophus resolution , total tophus burden in patients with multiple tophi , tophus size at baseline , and the relationship between tophus response and urate-lowering efficacy .


Baseline subcutaneous tophi were analyzed quantitatively using computer-assisted digital images in patients receiving pegloticase ( 8 mg biweekly or monthly ) or placebo in the RCTs , and pegloticase in the OLE .


Tophus response , a secondary endpoint in the trials , was evaluated two ways .


Overall tophus CR was the proportion of patients achieving a best response of CR ( without any new/enlarging tophi ) and target tophus complete response ( TT-CR ) was the proportion of all tophi with CR .


Among 212 patients randomized in the RCTs , 155 ( 73 % ) had 1 tophus and 547 visible tophi were recorded at baseline .


Overall tophus CR was recorded in 45 % of patients in the biweekly group ( P = 0.002 versus placebo ) , 26 % in the monthly group , and 8 % in the placebo group after six months of RCT therapy .


TT-CR rates at six months were 28 % , 19 % , and 2 % of tophi , respectively .


Patients meeting the primary endpoint of sustained urate-lowering response to therapy ( responders ) were more likely than nonresponders to have an overall tophus CR at six months ( 54 % vs 20 % , respectively and 8 % with placebo ) .


Pegloticase reduced tophus burden in patients with refractory tophaceous gout , especially those achieving sustained urate-lowering .


Complete resolution of tophi occurred in some patients by 13 weeks and in others with longer-term therapy .


NCT00325195 , NCT01356498 .


The present study was designed to determine the effect of short-term moderate-intensity exercise training on arterial stiffness in patients with chronic kidney disease ( CKD ) stage3 .


Randomized controlled trial with a parallel-group design .


Testing and training sessions were performed at Springfield College .


46 ( treatment group , n = 25 ; control group , n = 21 ) patients with CKD with diabetes and/or hypertension completed the study .


The aerobic training program consisted of 16 weeks of supervised exercise training at 50 % -60 % peak oxygen uptake ( Vo2peak ) 3 times per week , while the control group remained sedentary .


Identical testing procedures were performed following the 16-week intervention .


The primary outcome was arterial stiffness .


Secondary outcomes were aerobic capacity , various blood parameters ( endothelin 1 , nitrate/nitrite , and high-sensitivity C-reactive protein ) , and health-related quality of life .


Arterial stiffness was assessed with aortic pulse wave velocity ( PWV ) , aerobic capacity by Vo2peak , blood parameters by enzyme-linked immunosorbent assays , and health-related quality of life by the 36-Item Short Form Health Survey ( SF-36 ) .


Participants attended 4 sessions before being randomly assigned to either the treatment or control group .


Participants gave consent during the first session , whereas a graded exercise test with measurement of Vo2peak was completed during the second session .


During sessions 3 and 4 , aortic PWV was measured at rest prior to 40 minutes of either moderate-intensity exercise training or seated rest .


A venous blood sample was obtained prior to exercise or rest and participants completed the SF-36 questionnaire .


16 weeks of training led to an 8.2 % increase in Vo2peak for the treatment group ( P = 0.05 ) , but no changes in aortic PWV .


Randomization was not concealed and was violated on one occasion ; also , use of an indirect measurement of endothelial function and the short duration of the intervention .


Short-term moderate-intensity exercise training does not alter arterial stiffness in patients with CKD , but seems to reduce endothelin 1 levels .


Treatment satisfaction of men receiving phosphodiesterase 5 inhibitors ( PDE5 ) for erectile dysfunction ( ED ) and their partners is essential to successful long-term therapy .


This study aims to assess treatment satisfaction , in men with a partial response to on-demand ( PRN ) PDE5 and their female partners , following tadalafil 5mg once daily or placebo .


The study was randomized , double-blind , parallel , and placebo-controlled in men primarily with mild to moderate ED .


Treatment satisfaction was assessed following a 4-week maximum dose PRN lead-in , 4-week nondrug washout , and treatment through 12 weeks .


Men were 18 years old with ED for 3 months and International Index of Erectile Function Erectile Function score of 17 and < 26 at screening and < 26 following PRN lead-in .


Treatment satisfaction was assessed using the Treatment Satisfaction Scale ( TSS ) for patients and partners .


TSS domain scores range from 0 to 100 , with higher values indicating greater satisfaction .


Statistical comparisons were made using analysis of covariance .


Treatment satisfaction was significantly greater with tadalafil once daily vs. placebo across all TSS domains for both patients and their partners ( all P < 0.001 ) .


For patients , mean scores for the TSS domains Confidence to Complete Sexual Activity and Satisfaction with Orgasm ranged from 53.7 to 57.8 after the PRN lead-in and 26.7 to 31.9 following the nondrug washout .


Following randomized treatment , scores for tadalafil and placebo were 55.4 and 32.6 , respectively , for Confidence to Complete Sexual Activity and 57.5 and 37.9 , respectively , for Satisfaction with Orgasm .


Results were comparable for other TSS domains and between men and their partners .


Treatment satisfaction was comparable for tadalafil 5mg once daily and PRN PDE5 for both patients and female partners , suggesting that tadalafil once daily is a viable therapy option for men with ED who had a partial response to PRN PDE5 therapy .


Despite recent declines among young children , obesity remains a public health burden in the United States , including among Latino/Hispanic children .


The determining factors are many and are too complex to fully address with interventions that focus on single factors , such as parenting behaviors or school policies .


In this article , we describe a multisector , multilevel intervention to prevent and control childhood obesity in predominantly Mexican-origin communities in Southern California , one of three sites of the CDC-funded Childhood Obesity Research Demonstration ( CA-CORD ) study .


CA-CORD is a partnership between a university-affiliated research institute , a federally qualified health center , and a county public health department .


We used formative research , advisory committee members ' recommendations , and previous research to inform the development of the CA-CORD project .


Our theory-informed multisector , multilevel intervention targets improvements in four health behaviors : fruit , vegetable , and water consumption ; physical activity ; and quality sleep .


Intervention partners include 1200 families , a federally qualified health center ( including three clinics ) , 26 early care and education centers , two elementary school districts ( and 20 elementary schools ) , three community recreation centers , and three restaurants .


Intervention components in these sectors target changes in behaviors , policies , systems , and the social and physical environment .


Evaluation activities include assessment of the primary outcome , BMI z-score , at baseline , 12 - , and 18-months post-baseline , and sector evaluations at baseline , 12 , and 24 months .


Identifying feasible and effective strategies to prevent and control childhood obesity has the potential to effect real changes in children 's current and future health status .


Local anesthesia used for incision and drainage of abscesses is known to be painful .


We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage ( I&D ) of skin abscesses .


This was a prospective , double-blind , randomized , controlled trial carried out in the Emergency Department ( ED ) of an adult tertiary referral center .


Adult patients with a skin abscess in need of I&D were randomized to one of two groups .


One group received a lidocaine/tetracaine patch and injectable normal saline for anesthesia .


The second group received a placebo patch and injectable1 % lidocaine .


A visual analog pain scale was used to record the patient 's pain level prior to treatment , during the procedure , and after I&D .


There were 20 patients enrolled in the study , including 12 randomized to the lidocaine/tetracaine patch and 8 to the injectable lidocaine .


Pain scores preprocedure were similar in the two groups .


Pain scores during I&D and postprocedure were compared between groups using a paired t-test .


Patients receiving injectable lidocaine experienced pain that was similar ( 50.1 5.9 mm ; 95 % confidence interval [ CI ] 45.2-55 .1 ) to those receiving the transdermal lidocaine/tetracaine patch ( 60.1 mm 11.0 ; 95 % CI = 55.2-68 .1 ) , p = 0.04 , with a power of 80 % to detect a difference of 20 mm at p 0.05 ; although this was statistically significant , it was not clinically significant .


There was also no statistical difference between the two groups in the postprocedure pain scores ( p = 0.65 ) .


Local injection of lidocaine provided clinically similar analgesia compared to the lidocaine/tetracaine patch during I&D of skin abscesses in the ED .


Pain at presentation and after the procedure was similar in both groups .


Emergency physicians should continue to use a local injected anesthetic for I&D of skin abscesses until a less painful alternative is identified .


To evaluate the efficacy and safety of selective laser trabeculoplasty ( SLT ) as a replacement for medical therapy in primary open-angle glaucoma ( POAG ) .


A prospective , randomized , controlled study.SLT treatment with SOLO SLT Nd : YAG laser was provided to 45 participants with advanced POAG ( 67 eyes , IOP 21 mmHg , 1 mmHg = 0.133 kPa ) under anti-glaucomatous medications control ) .


A table of random numbers was created by simple randomization method .


Participants were randomly divided into two groups : the standard-energy group ( 34 eyes ) , which received a 270 standard-energy SLT treatment and the sub-threshold energy group ( 33 eyes ) , which received a 360 sub-threshold energy treatment .


The intraocular pressure ( IOP ) before and after SLT , daytime IOP curve , dosage of anti-glaucoma drugs and treatment complications were observed , which were be followed up for 6-9 months ( average 6.4 months ) .


Two-tailed t-test or paired t test was used when the continuous variables were normal distribution , such as the basic data , daily fluctuations of IOP , laser energy .


Non-parametric Mann-Whitney U test or Wilcoxon rank test was used when data was not distributed normally , such as drug category .


Chi-square or Fisher 's exact test was used when count variables such as success rate and complications were analyzed .


The number of anti-glaucomatous drugs used in the standard-energy group and the sub-threshold energy group before SLT was ( 2.3 0.5 ) and ( 2.1 0.4 ) , respectively ; whereas , after the last treatment , it reduced to ( 1.3 0.5 ) and ( 1.1 0.3 ) , respectively ( Z = -5.477 , -5.396 ; P < 0.05 ) .


The success rate of the standard-energy group and the sub-threshold energy group was 91.1 % , and 87.9 % , respectively , which was not significant different ( P = 0.70 ) .


Laser treatment was found to reduce the IOP fluctuation during the daytime.IOP fluctuation decreased from ( 3.6 1.0 ) mmHg to ( 2.3 1.0 ) mmHg in the standard-energy group , and decreased from ( 3.9 1.4 ) mmHg to ( 2.4 0.9 ) mmHg in the sub-threshold energy group , which was significant different ( t = 4.911 , 4.679 ; P < 0.05 ) .


The total laser energy of the standard-energy group ( 47.8 6.0 ) mJ was higher than the sub-threshold energy group ( 43.2 5.1 ) mJ ( t = 12.006 , 3.233 ; P < 0.05 ) .


However , there was no significant difference in the daily IOP fluctuations , success rate , reduction of medication categories , preoperative and postoperative IOP , and adverse reactions between the two groups .


SLT is a safe and effective replacement for medical therapy in primary open-angle glaucoma treatment .


SLT could reduce the applications of anti-glaucoma drugs .


There was no significant difference between therapeutic effects of which eyes received 360 sub-threshold energy and 270 standard-energy .


Aging results in a decline in the function of the respiratory muscles .


Inspiratory muscle training is emerging as a possible intervention to attenuate the decline of respiratory muscles in the elderly .


The aim of this study was to evaluate the efficacy of inspiratory muscle training on respiratory strength , diaphragm thickness , and diaphragmatic mobility in elderly women .


This was a controlled , randomized , and double-blind clinical trial , performed on 22 elderly women distributed in two groups , training ( TG ) and control ( CG ) .


Over an 8-week period a moderate intensity inspiratory muscle training protocol was followed in the TG , while CG followed a sham protocol .


In addition maximum expiratory and inspiratory pressure , mobility of the diaphragm and diaphragmatic thickness were evaluated by ultrasound .


After training , in TG maximal inspiratory pressure , maximal expiratory pressure , diaphragm thickness , and mobility increased by 37 % , 13 % , 11 % , and 9 % respectively , and their values were significantly higher than CG ( p < .005 , p = .013 , p = .001 , and p = .001 ) .


Inspiratory muscle training of moderate intensity improves respiratory muscle strength , diaphragm thickness , and diaphragm mobility in elderly women and it should be considered to minimize changes associated with senescence .


Mobile technology can improve lifestyle programs , but the monitoring techniques and carer feedback need to be optimized .


To this end , we investigated the efficacy of telemonitoring physical activity and nutrition over 12 months in patients with metabolic syndrome in a randomized , parallel-group , open trial .


Screening all over Germany yielded 184 patients with metabolic syndrome .


All patients attended a single 2-hour instruction meeting in their region concerning a combination diet and the importance of physical activity .


Thereafter they were randomized into a control group ( controls , n = 62 ) or one of 2 different intervention groups .


Both intervention groups were issued accelerometers , which measured physical activity , recorded daily weight and calorie intake , and transmitted these data to a central server for use by patient carers .


In the Active Body Control Program of University of Magdeburg ( ABC ) intervention group ( n = 60 ) , information and motivation was ensured by weekly letters .


In the 4sigma telephone coaching ( 4S ) intervention group ( n = 58 ) , this was accomplished by monthly telephone calls from the carers .


Clinical and biochemical data for all patients were collected at 0 , 4 , 8 , and 12 months without any regular face-to-face meetings between patients and carers .


The primary endpoint was weight loss and the secondary endpoint was the presence of metabolic syndrome .


After 12 months the dropout rates in the control , 4S , and ABC groups were respectively 35 % , 17 % , and 18 % .


The adjusted relative weight losses after 12 months were respectively 3.7 % , 8.6 % , and 11.4 % ( all p < 0.000 versus baseline ) .


ABC was more effective than 4S ( p = 0.041 ) ; 43 % of the patients completing the study in the ABC group lost more than 15 % of their baseline weight .


The diagnosis of metabolic syndrome was no longer applicable in 58 % of the cases in the ABC group , in 41 % of the 4S group , and in 33 % of the controls .


Telemonitoring of physical activity and nutrition markedly improves weight loss and markers of metabolic syndrome .


Little is known about the transfer of essential fatty acids ( FAs ) across the human blood-brain barrier ( BBB ) in adulthood .


In this study , we investigated whether oral supplementation with omega-3 ( n-3 ) FAs would change the FA profile of the cerebrospinal fluid ( CSF ) .


A total of 33 patients ( 18 receiving the n-3 FA supplement and 15 receiving placebo ) were included in the study .


These patients were participants in the double-blind , placebo-controlled randomized OmegAD study in which 204 patients with mild Alzheimer 's disease ( AD ) received 2.3 g n-3 FA [ high in docosahexaenoic acid ( DHA ) ] or placebo daily for 6 months .


CSF FA levels were related to changes in plasma FA and to CSF biomarkers of AD and inflammation .


At 6 months , the n-3 FA supplement group displayed significant increases in CSF ( and plasma ) eicosapentaenoic acid ( EPA ) , DHA and total n-3 FA levels ( P < 0.01 ) , whereas no changes were observed in the placebo group .


Changes in CSF and plasma levels of EPA and n-3 docosapentaenoic acid were strongly correlated , in contrast to those of DHA .


Changes in DHA levels in CSF were inversely correlated with CSF levels of total and phosphorylated tau , and directly correlated with soluble interleukin-1 receptor type II .


Thus , the more DHA increased in CSF , the greater the change in CSF AD/inflammatory biomarkers .


Oral supplementation with n-3 FAs conferred changes in the n-3 FA profile in CSF , suggesting transfer of these FAs across the BBB in adults .


Patients with advanced squamous-cell non-small-cell lung cancer ( NSCLC ) who have disease progression during or after first-line chemotherapy have limited treatment options .


This randomized , open-label , international , phase 3 study evaluated the efficacy and safety of nivolumab , a fully human IgG4 programmed death 1 ( PD-1 ) immune-checkpoint-inhibitor antibody , as compared with docetaxel in this patient population .


We randomly assigned 272 patients to receive nivolumab , at a dose of 3 mg per kilogram of body weight every 2 weeks , or docetaxel , at a dose of 75 mg per square meter of body-surface area every 3 weeks .


The primary end point was overall survival .


The median overall survival was 9.2 months ( 95 % confidence interval [ CI ] , 7.3 to 13.3 ) with nivolumab versus 6.0 months ( 95 % CI , 5.1 to 7.3 ) with docetaxel .


The risk of death was 41 % lower with nivolumab than with docetaxel ( hazard ratio , 0.59 ; 95 % CI , 0.44 to 0.79 ; P < 0.001 ) .


At 1 year , the overall survival rate was 42 % ( 95 % CI , 34 to 50 ) with nivolumab versus 24 % ( 95 % CI , 17 to 31 ) with docetaxel .


The response rate was 20 % with nivolumab versus 9 % with docetaxel ( P = 0.008 ) .


The median progression-free survival was 3.5 months with nivolumab versus 2.8 months with docetaxel ( hazard ratio for death or disease progression , 0.62 ; 95 % CI , 0.47 to 0.81 ; P < 0.001 ) .


The expression of the PD-1 ligand ( PD-L1 ) was neither prognostic nor predictive of benefit .


Treatment-related adverse events of grade 3 or 4 were reported in 7 % of the patients in the nivolumab group as compared with 55 % of those in the docetaxel group .


Among patients with advanced , previously treated squamous-cell NSCLC , overall survival , response rate , and progression-free survival were significantly better with nivolumab than with docetaxel , regardless of PD-L1 expression level .


( Funded by Bristol-Myers Squibb ; CheckMate 017 ClinicalTrials.gov number , NCT01642004 . )


To assess same-day and delayed reports of pain intensity during and after second-trimester medical termination of pregnancy ( MTOP ) .


A prospective randomized trial ( 217 women ) comparing 1 - and 2-day mifepristone-misoprostol intervals .


Women reported intense pain [ median visual analogue scale ( interquartile range ) ] related to expulsion of the fetus [ 6 ( 0-10 ) ] .


Delayed reports of maximal pain described the pain as more intense than same-day reports [ 8 ( 3-10 ) vs. 7 ( 1-10 ) , p < .001 ] .


Most women reported and readily remembered intense pain associated with fetal expulsion during second-trimester MTOP .


Adequate , properly timed pain management during second-trimester MTOP is crucial .


To determine the effect of reduced 80-kV tube voltage with increased 370-mAs tube current on radiation dose , image quality and estimated myocardial blood flow ( MBF ) of dynamic CT stress myocardial perfusion imaging ( CTP ) in patients with a normal body mass index ( BMI ) compared with a 100-kV and 300-mAs protocol .


Thirty patients with a normal BMI ( < 25 kg/m ( 2 ) ) with known or suspected coronary artery disease underwent adenosine-stress dual-source dynamic CTP .


Patients were randomised to 80-kV/370-mAs ( n = 15 ) or 100-kV/300-mAs ( n = 15 ) imaging .


Maximal enhancement and noise of the left ventricular ( LV ) cavity , contrast-to-noise ratio ( CNR ) and MBF of the two groups were compared .


Imaging with 80-kV/370-mAs instead of 100-kV/300-mAs was associated with 40 % lower radiation dose ( mean dose-length product , 35966 vs 628112 mGy [ Symbol : see text ] cm ; P < 0.001 ) with no significant difference in CNR ( 34.513.4 vs 33.510.4 ; P = 0.81 ) or MBF in non-ischaemic myocardium ( 0.950.20 vs 0.990.25 ml/min/g ; P = 0.66 ) .


Studies obtained using 80-kV/370-mAs were associated with 30.9 % higher maximal enhancement ( 804204 vs 614115 HU ; P < 0.005 ) , and 31.2 % greater noise ( 22.73.5 vs 17.42.6 ; P < 0.001 ) .


Dynamic CTP using 80-kV/370-mA instead of 100-kV/300-mAs allowed 40 % dose reduction without compromising image quality or MBF .


Tube voltage of 80-kV should be considered for individuals with a normal BMI .


CT stress perfusion imaging ( CTP ) is increasingly used to assess myocardial function .


Dynamic CTP is feasible at 80-kV in patients with normal BMI .


An 80-kV/370-mAs protocol allows 40 % dose reduction compared with 100-kV/300-mAs .


Contrast-to-noise ratio and myocardial blood flow of the two protocols were comparable .


Cow 's milk protein allergy ( CMPA ) is treated using an elimination diet with an extensive protein hydrolysate .


We explored whether a thickened or nonthickened version was best for infants with suspected CMPA , which commonly causes regurgitation/vomiting .


Diagnosis of CMPA was based on a positive challenge test .


We compared the efficacy of two casein extensive hydrolysates ( eCH ) , a nonthickened version ( NT-eCH ) and a thickened version ( T-eCH ) , using a symptom-based score covering regurgitation , crying , stool consistency , eczema , urticarial and respiratory symptoms .


A challenge was performed in 52/72 infants with suspected CMPA and was positive in 65.4 % .


All confirmed CMPA cases tolerated eCH .


The symptom-based score decreased significantly in all infants within a month , and the highest reduction was in those with confirmed CMPA .


Regurgitation was reduced in all infants ( 6.43.2-2 .82.9 , p < 0.001 ) , but fell more with the T-eCH ( -4.23.2 regurgitations/day vs. -3.04.5 , ns ) , especially in infants with a negative challenge ( -3.94.0 vs. -1.93.4 , ns ) .


eCH fulfilled the criteria for a hypoallergenic formula , and the NT-eCH and T-eCH formulas both reduced CMPA symptoms .


The symptom-based score is useful for evaluating how effective dietary treatments are for CMPA .


The treatment of gingival inflammation is associated with improved glycaemic control in diabetic patients .


The goal of this parallel-randomised controlled trial ( RCT ) was to test the shortterm effects of professional oral hygiene procedures on plasma glucose levels in systemically healthy individuals .


Systemically healthy individuals with gingivitis and no sign of periodontitis were enrolled at a private practice in Italy .


Patients were randomised to either a 1 hour ( h ) session of professional oral hygiene procedures or to 1 h in the waiting room .


Not fasting blood glucose levels were assessed by a blind examiner at baseline ( T0 ) , 1 h ( T1 ) and 2 h ( T2 ) after procedures and finally 1 week after ( T3 ) .


Oral hygiene procedures were then performed also in the control group .


Twenty patients were randomly allocated to each group .


There were no drop-outs .


Blood glucose levels at T0 ( P = 0.0001 ) and time of measurement ( P = 0.0001 ) were statistically significant , while oral hygiene procedures were not ( mean difference between groups 0.77 mg/dl , 95 % CI -2.64 mg/dl ; 4.18 mg/dl , P = 0.6581 ) .


Mean blood glucose levels decreased between T0 and T1 , were stable between T1 and T2 and showed similar levels to baseline after 1 week ( T3 ) for both groups .


This short-term RCT showed that professional oral hygiene procedures were not able to influence plasma glucose levels in individuals with gingivitis , but otherwise systemically healthy .


The aim of the study was to extend research on the potential benefits of adding ongoing feedback , coaching , and consultation to initial therapist training workshops to ensure fidelity of delivery of evidence-based practices , specifically for the Incredible Years parenting program .


A randomized controlled trial compared two models for training therapists to deliver the parenting program for children at high risk of developing conduct problems .


Therapists ( N = 56 ) from ten community-based mental health service organizations in California were trained in either a three-day workshop model ( N = 25 ) , based on active , experiential , self-reflective , principle-based learning , video modeling , and manuals , or an enhanced training model ( N = 31 ) that included all elements of the workshop model plus ongoing expert coaching , video review of and feedback on group sessions , and consultation for therapists and agency supervisors .


Overall fidelity across both conditions was rated > 3 on a 5-point scale in seven of eight domains measured .


Therapists in the condition that received ongoing coaching and consultation were significantly stronger in four of the domains : practical support , collaboration , knowledge , and skill at mediating vignettes .


Consultation and expert coaching for training therapists beyond the standard three-day training enhanced skills and therapists ' adherence to the model .


It is unclear if a modest reduction in dietary salt intake has beneficial effects on vascular function .


The aim was to compare the effects of 9 g salt/day with 6 g salt/day intake on measures of vascular function and explore mechanisms of effect in overweight and obese adults .


Twenty-five overweight/obese subjects ( BMI 27-40 kg/m ( 2 ) ) completed a randomised cross-over study of 6 weeks each on a reduced salt ( RS ) ( 6 g/day ) and usual salt diet ( US ) ( 9 g/day ) .


Flow-mediated-dilatation ( FMD ) , 24 h blood pressure ( BP ) , augmentation index ( AIx ) , pulse wave velocity ( PWV ) , plasma and urinary nitrate/nitrite , asymmetric dimethylarginine ( ADMA ) , renin , aldosterone and endothelin-1 and vascular adhesion molecules were measured after 2 days and 6 weeks .


Adherence to the diets was determined from two 24 h urine collections .


Urinary sodium excretion was 155 58 mmol/24 h US vs 113 45 mmol/24 h RS ( p = 0.002 ) .


Following the RS diet there was a significant improvement in FMD from 3.5 2.8 % to 5.6 2.8 % ( P < 0.001 ) and decrease in serum endothelin-1 from 1.45 0.38 pg/ml to 1.25 0.39 pg/ml ( P < 0.05 ) .


Endothelium-independent vasodilatation was also significantly different between treatments ( P < 0.05 ) .


AIx , PWV , serum ADMA and plasma and urinary nitrate/nitrite concentrations were not different between treatments .


Change in FMD was related to the urinary sodium : creatinine ratio ( r = -0.47 , P < 0.05 ) and was independent of blood pressure .


Aldosterone and renin were unchanged .


A small reduction in dietary salt intake of 3 g/day improves endothelial function in normotensive overweight and obese subjects .


This response may be mediated by serum endothelin-1 .


This small reduction in salt had no effect on aldosterone and renin concentrations .


This trial was registered with the Australian and New Zealand Clinical Trials Registry Unique Identifier : ACTRN12609000321246 http://www.anzctr.org.au/ACTRN12609000321246.aspx .


To evaluate the potential of antimicrobial photodynamic therapy ( aPDT ) as an adjunct to scaling and root planing ( SRP ) in the treatment of chronic periodontitis .


In a single-centred randomized and controlled clinical trial , 90 patients ( 51 females and 39 males ) with untreated chronic periodontitis were randomly assigned to receive SRP with aPDT ( test group ) or SRP alone ( control group ) .


Clinical parameters and halitosis were recorded for 6months after treatment by a periodontist who was blinded to the procedure .


Inter-group and intra-group statistical analyses were performed .


Significant difference between the two groups with respect to each variable was assessed using non-parametric Rank Order ancova .


Probing pocket depth and clinical attachment levels showed statistically significant reduction in the test group on evaluation at 3months and 6months as compared to the control group ( p < 0.05 ) .


A statistically significant improvement in gingival index and gingival bleeding index was seen for the test group after 2weeks and 1month of aPDT ( p < 0.01 ) , whereas the improvement in gingival index and gingival bleeding index at 3months and in plaque index at 2weeks after aPDT was less ( p < 0.05 ) .


Also , a significant difference was detected for the test group at 1month in terms of halitosis ( p < 0.05 ) , which did not persist for long .


Antimicrobial photodynamic therapy acts as a beneficial adjunct to SRP in non-surgical treatment and management of chronic periodontitis in short-term .


Further studies are required to assess the long-term effectiveness of aPDT .


To evaluate weight retention 12 months postpartum and factors associated among women who had received prenatal care at Health Care Centers in Porto Alegre , southern Brazil .


Pregnant women in the last trimester were identified at 20 Health Care Centers .


Socioeconomic , demographic and anthropometrics data were obtained .


Six and 12 months after delivery , the women received home visits for anthropometric measures .


The gestational weight gain was defined by pre-pregnancy Body Mass Index ( BMI ) .


Weight retention was defined as the difference between pre-gestational weight and weight at postpartum .


Data were analyzed using McNemar 's Test , ANOVA with Bonferroni correction and multiple linear regression .


Of the 715 pregnant women recruited , 545 were assessed 12 months after delivery .


Women were more likely to be overweight 12 months postpartum compared to the pre-pregnancy period ( 52.9 versus 36.7 % ) and weight retention during the 12 months postpartum was more than 10 kg in 30.7 % of the women .


Weight retention in the postpartum period was higher among women who were overweight ( 9.9 7.7 kg ) compared to those who were of normal weight during the pre-pregnancy period ( 7.6 6.2 kg ) .


Pre-pregnancy BMI , gestational weight gain , and maternal age were associated with gestational weight retention 12 months postpartum ( p < 0.001 ) .


Adequate prenatal care is necessary to minimize the adverse effects of excessive weight gain during pregnancy on women 's health .


Few anaphylaxis education materials have been prospectively evaluated in randomized controlled trials .


Our objective was to evaluate the American Academy of Allergy , Asthma & Immunology Anaphylaxis Wallet Card ( AAAAI-AWC ) as an anaphylaxis education mini-handout for health care professionals .


We performed a randomized controlled study of the AAAAI-AWC with residents in general pediatrics at Miami Children 's Hospital .


Participants in the intervention group completed a pretest about anaphylaxis , heard a 3-minute PowerPoint presentation based on the AAAAI-AWC , reviewed the AAAAI-AWC , and discussed it with the presenter .


After this , participants took a post-test immediately and a follow-up test 4 weeks later .


Participants in the control group took the pretest , were handed an AAAAI-AWC , studied it briefly , then took the post-test immediately and the follow-up test 4 weeks later .


Fifty-five residents participated .


Regardless of the amount of time spent studying the AAAAI-AWC , when the pretests were compared with the post-tests and follow-up tests , residents in both the intervention and control groups were more likely to recognize anaphylaxis symptoms ( P < .05 ) , name asthma as the most common comorbid disease in children with fatal or near-fatal anaphylaxis ( P < .05 ) , and recall the names of epinephrine auto injectors ( P < .05 ) and the epinephrine doses available in these auto injectors ( P < .05 ) .


When the pretests were compared with the post-tests and the follow-up tests , residents in the intervention group were more likely than controls to identify the body organ systems involved in severe or fatal anaphylaxis correctly ( P < .05 ) .


The AAAAI-AWC is a practical , concise anaphylaxis education mini-handout for pediatric residents , a time-challenged group of health care professionals .


To investigate whether functionally based resistance exercise could improve strength , physical function , and disability among prostate cancer survivors ( PCS ) on androgen deprivation therapy ( ADT ) ; and to explore potential mediators of changes in outcomes from exercise .


Randomized controlled trial .


Academic medical center .


PCS ( N = 51 ; mean age , 70.2 y ) on ADT .


PCS were randomized to moderate to vigorous intensity resistance training or stretching ( placebo control ) for 1 year .


Maximal leg press and bench press strength , objective and self-reported physical function , and self-reported disability .


Hierarchical linear modeling was used to test for significant group time differences adjusting for covariates .


Retention in the study was 84 % , and median attendance to supervised classes was 84 % in the resistance group .


No study-related injuries occurred .


Maximal leg strength ( P = .032 ) and bench press strength ( P = .027 ) were improved after 1 year of resistance training , whereas little change occurred from stretching .


Self-reported physical function improved with resistance training , whereas decreases occurred from stretching ( P = .016 ) .


Disability lessened more with resistance training than stretching ( P = .018 ) .


One-year change in leg press strength mediated the relation between groups ( resistance or stretching ) and 1-year change in self-reported disability ( P < .05 ) .


One year of resistance training improved muscle strength in androgen-deprived PCS .


Strengthening muscles using functional movement patterns may be an important feature of exercise programs designed to improve perceptions of physical function and disability .


Findings from this study contribute to the mounting evidence that exercise should become a routine part of clinical care in older men with advanced prostate cancer .


Few studies have assessed associations between craving and subsequent opioid use .


We prospectively evaluated the relative utility of two craving questionnaires to predict opioid use among opioid-dependent patients in outpatient treatment .


Opioid-dependent patients ( n = 147 ) initiating buprenorphine treatment were assessed every two weeks for 3 months .