Stand-alone balloon dilation of the maxillary sinus ostia and ethmoid infundibula performed in the office is well tolerated and effectively treats both CRS and RARS .


This study investigated the effect of the knee position during wound closure on early knee function recovery after total knee arthroplasty ( TKA ) .


This study included @ primary total knee arthroplasties due to osteoarthritis .


The patients were randomized according to the type of wound closure : extension group for full extension and flexion group for @ flexion .


The incision of articular capsule was marked for precise wound alignment .


In the flexion group , the knee was kept in high flexion for @ to @ min after wound closure .


The two groups were treated with the same postoperative rehabilitation exercises .


The range of motion ( ROM ) , visual analogue scale ( VAS ) score of anterior knee pain , Knee Society Score ( KSS ) and postoperative complications were assessed at @ weeks , @ months and @ months , postoperatively .


At @ weeks and @ months postoperatively , the ROM in flexion group was @ and @ respectively , with @ and @ in extension group , respectively ; The VAS score of anterior knee pain in flexion group was @ and @ , respectively , with @ and @ in extension group , respectively .


The ROM and VAS pain score of the two groups were significantly different at these two time points , with no significant difference at @ months postoperatively .


The two groups were not significantly different in KSS , and no apparent complication was observed at three time points .


Marking the articular capsule incision , wound closure in flexion and high flexion after wound closure can effectively decrease anterior knee pain after TKA and promote the early recovery of ROM .


The live attenuated @DD Yellow Fever vaccine is one of the most successful prophylactic interventions for controlling disease expansion ever designed and utilized in larger scale .


However , increase on worldwide vaccine demands and manufacturing restrictions urge for more detailed dose sparing studies .


The establishment of complementary biomarkers in addition to PRNT and Viremia could support a secure decision-making regarding the use of @DD YF vaccine subdoses .


The present work aimed at comparing the serum chemokine and cytokine kinetics triggered by five subdoses of @DD YF Vaccine .


Neutralizing antibody titers , viremia , cytokines and chemokines were tested on blood samples obtained from eligible primary vaccinees .


The results demonstrated that a fifty-fold lower dose of @DD-YF vaccine ( @ IU ) is able to trigger similar immunogenicity , as evidenced by significant titers of anti-YF PRNT .


However , only subdoses as low as @,@ IU elicit viremia kinetics with an early peak at five days after primary vaccination equivalent to the current dose ( @,@ IU ) , while other subdoses show a distinct , lower in magnitude and later peak at day @ post-vaccination .


Although the subdose of @ IU is able to trigger equivalent kinetics of IL-@ / CXCL-@ and MCP-@ / CCL-@ , only the subdose of @,@ IU is able to trigger similar kinetics of MIG/CXCL -@ , pro-inflammatory ( TNF , IFN - and IL-@ ) and modulatory cytokines ( IL-@ and IL-@ ) .


The analysis of serum biomarkers IFN - and IL-@ , in association to PRNT and viremia , support the recommendation of use of a ten-fold lower subdose ( @,@ IU ) of @DD-YF vaccine .


To compare the effects of different anesthesia techniques on tourniquet-related ischemia-reperfusion by measuring the levels of malondialdehyde ( MDA ) , ischemia-modified albumin ( IMA ) and neuromuscular side effects .


Sixty ASAI-II patients undergoing arthroscopic knee surgery were randomised to three groups .


In Group S , intrathecal anesthesia was administered using levobupivacaine .


Anesthesia was induced and maintained with sevoflurane in Group I and TIVA with propofol in Group T. Blood samples were obtained before the induction of anesthesia ( t@ ) , @ min after tourniquet inflation ( t@ ) , immediately before ( t@ ) , and @ min ( t@ ) , @ min ( t@ ) , @ min ( t @ ) , @ h ( t@ ) , @ h ( t@ ) , and @ h ( t@ ) after tourniquet release .


MDA and IMA levels increased significantly compared with baseline values in Group S at t@-t @ and t@-t@ .


MDA levels in Group T and Group I were significantly lower than those in Group S at t@-t@ and t@-t@ .


IMA levels in Group T were significantly lower than those in Group S at t@-t@ .


Postoperatively , a temporary @/@ loss of strength in dorsiflexion of the ankle was observed in @ patients in Group S and @ in Group I.


TIVA with propofol can make a positive contribution in tourniquet-related ischemia-reperfusion .


To determine the amount and type of feedback needed to improve pharmacy students ' problem-solving skills using team-based learning ( TBL ) and a problem-solving rubric .


A problem-solving rubric was developed to assess the ability of pharmacy students ' to prioritize , organize , and defend the best and alternative options on TBL cases The study involved @ groups of pharmacy students : second-year students in a cardiology class who received no feedback ( control group ) , third-year students in an endocrinology class who received written feedback only , and third-year students in an endocrinology class who received written and verbal feedback .


Students worked in groups on all TBL cases except the first and last one ( beginning and end of course ) , which students completed independently as it served as a pretest and posttest .


Significant improvements were seen in the ability of the third-year students who received verbal and written feedback to prioritize the information presented in the case and in their total score on the problem-solving rubric .


Providing pharmacy students with written and verbal explanations may help them improve their problem-solving skills overall .


During verbal feedback , faculty members can provide more examples of how to improve and can field questions if needed .


In vitro and animal studies have reported conflicting results regarding an independent role for FSH in the regulation of bone turnover .


Our objective was to test the hypothesis that suppressing serum FSH while holding serum gonadal steroid levels stable in the eugonadal range will affect biochemical markers of bone metabolism in healthy men .


Eugonadal men aged @ to @ years participated in this randomized controlled trial at a tertiary care academic teaching hospital .


Participants received monthly GnRH analog injections to suppress FSH secretion plus daily topical testosterone gel in prespecified doses ( intervention group ) .


Controls received matching placebos ( control group ) .


Subjects in the intervention group were individually matched with subjects in the control group to ensure that the mean testosterone and estradiol levels ( measured every @ weeks during the @-week study period ) in the @ groups were similar .


Biochemical markers of bone resorption ( serum N-terminal telopeptide and C-terminal telopeptide ) , bone formation ( serum osteocalcin ) , and FSH were measured at baseline and after @ weeks of treatment .


Serum FSH declined by @ % in the control group and by @ % in the intervention group ( P < @ for the between-group difference ) .


Despite the substantial suppression of serum FSH in the intervention group , serum N-terminal telopeptide , C-terminal telopeptide , and osteocalcin did not change in the intervention group , nor were any between-group differences observed .


When gonadal steroid levels are held constant , short-to midterm suppression of FSH does not affect bone turnover in men .


FSH does not appear to be a significant regulator of bone metabolism in eugonadal men .


We analyzed data collected during the Active Ulcerative Colitis Trials ( ACT-@ and ACT-@ ) to assess relationships between serum concentrations of infliximab and outcomes of adults with moderate-to-severe ulcerative colitis .


We compared serum concentrations of infliximab with outcomes of @ patients with moderately-to-severely active ulcerative colitis who participated in ACT-@ or ACT-@ ; efficacy data were collected at weeks @ , @ , and @ ( for ACT-@ only ) .


Relationships between serum concentration of infliximab and efficacy outcomes were assessed using trend , logistic regression , and receiver operating characteristic curve analyses .


We also evaluated factors that affected the relationship between exposure and response .


Median serum concentrations of infliximab at weeks @ , @ , and/or @ were significantly higher in patients with clinical response , mucosal healing , and/or clinical remission than in patients who did not meet these response criteria .


There were statistically significant relationships between quartile of infliximab serum concentration and efficacy at these time points ( P < @ ) .


Infliximab therapy was effective for a smaller proportion of patients in the lowest quartile , and these patients had lower serum levels of albumin and a higher incidence of antibodies to infliximab than patients in other quartiles .


Although the relationship between exposure to infliximab and response varied among patients , approximate serum concentrations of @ g/mL infliximab at week @ of induction therapy and @ g/mL at steady-state during maintenance therapy produced optimal outcomes in patients .


Serum concentrations of infliximab are associated with efficacy in patients with moderate-to-severe ulcerative colitis ; however , complex factors determine the relationship between exposure to this drug and response .


A prospective evaluation of the value of measuring serum concentrations of infliximab should be performed before these data can be included in patient management strategies .


Clinicaltrials.gov numbers : NCT@ and NCT@ .


To determine the feasibility of a multicentre randomised controlled trial ( RCT ) to investigate whether digital rotation of the fetal head from occiput posterior ( OP ) position in the second stage of labour reduces the risk of operative delivery ( defined as caesarean section ( CS ) or instrumental delivery ) .


We conducted the study between December @ and December @ in a tertiary referral hospital in Australia .


A transabdominal ultrasound was performed early in the second stage of labour on women with cephalic , singleton pregnancies to determine the fetal position .


Those women with a fetus in the OP position were randomised to either a digital rotation or a sham procedure .


In all other ways , participants received their usual intrapartum care .


Data regarding demographics , mode of delivery , labour , post natal period and neonatal outcomes were collected .


One thousand and four women were consented , @ achieved full dilatation , and @ were randomised .


An additional portable ultrasound scan and a blinded ` sham ' digital rotation were acceptable to women and staff .


Operative delivery rates were @/@ in the digital rotation ( four CS and nine instrumental ) and @/@ in the sham ( three CS and nine instrumental ) groups , respectively .


A large double-blinded multicentre RCT would be feasible and acceptable to women and staff .


Strategies to improve recruitment such as consenting women with an effective epidural in active labour should be considered .


This would be the first RCT to answer a clinically important question which could significantly affect the operative delivery rate in Australia and internationally .


To observe the curative effects of rh-endostatin combined with DP regimen in treating patients with advanced esophageal cancer and analyze the correlation of CT perfusion ( CTP ) parameters and the expression of vascular endothelial growth factor ( VEGF ) .


Twenty patients with esophageal cancer confirmed pathologically were randomly divided into combined treatment ( rh-endostatin + DP regimen ) group and single chemotherapy group , @ patients in each group , respectively .


All patients were given conventional CT examination and CTP imaging for primary tumor .


The level of VEGF , the size of tumor and CTP parameters ( BF , BV , PS and MTT ) before treatment and after @ cycles of treatment were determined for the comparison and the correlation between CTP parameters and VEGF expression was analyzed .


the therapeutic effect of rh-endostatin + DP regimen group was superior to single chemotherapy group .


VEGF level after treatment in rh - endostatin + DP regimen group was obviously lower than single chemotherapy group ( P < @ ) .


The expression of VEGF had positive correlation with BF and BV but negative correlation with MTT .


Compared with treatment before for rh-endostatin + DP regimen group , BF , BV and PS decreased while MTT increased after treatment ( P < @ ) .


However , there were no significant differences between treatment before and after treatment in single chemotherapy ( P > @ ) .


Rh-endostatin can down-regulate the expression of VEGF in esophageal cancer , change the state of hypertransfusion and high permeability of tumor vessels and had the better curative effect and slighter adverse reactions when combined with chemotherapy .


Although its excellent results , laparoscopic sleeve gastrectomy ( LSG ) presents major complications ranging from @ % to @ % .


Among them , the staple line leak presents an incidence varying from @ % to @ % .


Many trials debated about different solutions in order to reduce leaks ' incidence .


No author has investigated the role of gastric decompression in the prevention of this complication .


Aim of our work is to evaluate if this procedure can play a role in avoiding the occurrence of staple line leaks after LSG .


Between January @ and November @ , @ patients were prospectively and randomly included in the study .


Seventy patients composed the group A , whose operations were completed with placement of nasogastric tube ; the other @ patients were included in the group B , in which no nasogastric tube was placed .


No statistical differences were observed between group A and group B regarding gender distribution , age , weight , and BMI .


No intraoperative complications and no conversion occurred in both groups .


Intraoperative blood loss ( @ @ vs. @ @ ml , respectively ) and operative time ( @ @ vs. @ @ min , respectively ) were comparable between the two groups ( p : NS ) .


One staple line leak ( @ % ) occurred on @th postoperative day in group A patients .


No leak was observed in group B patients .


Postoperative hospital stay was significantly longer in group A vs. group B patients ( @ @ vs. @ @ days , respectively , p : @ ) .


Routine placement of nasogastric tube in patients operated of LSG seems not useful in reducing leaks ' incidence .


To investigate the feasibility of conducting a cohort , factorial randomized controlled trial ( RCT ) in the treatment of patients with low back pain ( LBP ) .


Pragmatic feasibility factorial RCT nested within an observational cohort study in two general practices in York , United Kingdom .


Eight hundred forty-five patients aged between @ and @years who had consulted their general practitioner about LBP within the preceding @months were mailed an invitation to participate in a cohort trial , with the possibility of later joining a treatment RCT .


One hundred twenty-four patients consented to participate in the cohort and treatment trial , and one consented only to the cohort only .


Ultimately , @ patients were randomized into the nested RCT .


Outcomes included recruitment , acceptability , and attrition rates as measures of the feasibility of the design and Roland Morris Disability Questionnaire .


No statistically significant differences in outcome between treatment groups and usual care were found .


The design was feasible for the evaluation of different back pain treatments .


We found zero attrition after randomization and showed that for a remitting relapsing condition , the design allows us to recruit initially ineligible patients from the cohort .


Additional statistical analysis using regression discontinuity can also be used with this design .


Low-frequency nevirapine ( NVP ) - resistant variants have been associated with virologic failure ( VF ) of initial NVP-based combination antiretroviral therapy ( cART ) in women with prior exposure to single-dose NVP ( sdNVP ) .


We investigated whether a similar association exists in women without prior sdNVP exposure .


Pre-cART plasma was analyzed by allele-specific polymerase chain reaction to quantify NVP-resistant mutants in human immunodeficiency virus-infected African women without prior sdNVP who were starting first-line NVP-based cART in the OCTANE/A@ trial @ .


Associations between NVP-resistant mutants and VF or death were determined and compared with published results from women participating in the OCTANE/A@ trial @ who had taken sdNVP and initiated NVP-based cART .


Pre-cART NVP-resistant variants were detected in @ % ( @/@ ) of women without prior sdNVP exposure , compared to @ % ( @/@ ) with prior sdNVP exposure ( P < @ ) .


Among women without prior sdNVP exposure , @ of @ ( @ % ) with NVP-resistant variants experienced VF or death vs @ of @ ( @ % ) without such variants ( P = @ ) ; this compares with @ of @ ( @ % ) vs @ of @ ( @ % ) among women with prior exposure ( P = @ ) .


The risk of VF on NVP-based cART from NVP-resistant variants differs between sdNVP-exposed and - unexposed women .


This difference may be driven by drug-resistance mutations emerging after sdNVP exposure that are linked on the same viral genome .


The neurobehavioural symptoms and pain following traumatic brain injury ( TBI ) can be long-lasting .


The condition impairs the persons ' ability to function in their work , studies and gatherings with family and friends .


The aim of this study was to investigate dosage , safety and effects of methylphenidate on mental fatigue and pain .


Twenty-nine physically-well rehabilitated TBI victims , @ with a mild TBI and one with TBI and also with pain in the neck , shoulders and head were included in the study .


Methylphenidate was tested in each patient using three treatment strategies : no medication , low dose ( @mg@ ) and normal dose ( @mg@ ) for @ weeks using a randomized cross-over design .


Twenty-four patients completed the three treatment periods .


Five participants discontinued , four females due to adverse reactions and one male due to attenuated motivation .


Only minor adverse events were reported .


Methylphenidate significantly decreased mental fatigue , as evaluated by the Mental Fatigue Scale ( p < @ ) , and the effects on mental fatigue were dose-dependent .


No effect on pain was detected .


Methylphenidate decreased mental fatigue for subjects suffering a traumatic brain injury , the treatment is considered to be safe and is recommended , starting with a low dose .


Patients with severe OSA consume greater amounts of cholesterol , protein , and fat as well as have greater caloric expenditure .


However , it is not known whether their activity levels or diet change after treatment with CPAP .


To investigate this issue , serial assessments of activity and dietary intake were performed in the Apnea Positive Pressure Long-term Efficacy Study ( APPLES ) ; a @-month randomized controlled study of CPAP vs. sham CPAP on neurocognitive outcomes .


Subjects were recruited into APPLES at @ sites through clinic encounters or public advertisement .


After undergoing a diagnostic polysomnogram , subjects were randomized to CPAP or sham if their AHI was @ .


Adherence was assessed using data cards from the devices .


At the Tucson and Walla Walla sites , subjects were asked to complete validated activity and food frequency questionnaires at baseline and their @-month visit .


Activity and diet data were available at baseline and after @ months treatment with CPAP or sham in up to @ subjects ( @ CPAP , @ Sham ) .


Mean age , AHI , BMI , and Epworth Sleepiness Score ( ESS ) for this cohort were @ @ -LSB- SD -RSB- years , @ @ / h , @ @ kg/m ( @ ) , and @ @ , respectively .


The participants lacking activity and diet data were younger , had lower AHI and arousal index , and had better sleep efficiency ( p < @ ) .


The BMI was higher among women in both CPAP and Sham groups .


However , compared to women , men had higher AHI only in the CPAP group ( @ vs. @ ) .


Similarly , the arousal index was higher among men in CPAP group .


Level of adherence defined as hours of device usage per night at @ months was significantly higher among men in CPAP group ( @ @ vs. @ @ ) .


No changes in consumption of total calories , protein , carbohydrate or fat were noted after @ months .


Except for a modest increase in recreational activity in women ( @ @ vs. @ @ calories , p < @ ) , there also were no changes in activity patterns .


Except for a modest increase in recreational activity in women , OSA patients treated with CPAP do not substantially change their diet or physical activity habits after treatment .


The present experiment evaluated whether training involving throwing transferred to metric distance estimation ( i.e. , describing in feet and inches the distance between oneself and targets ) .


In prior work , we found that metric estimation training negatively transferred to throwing .


We explained our results in terms of cognitive intrusion .


The present study tested that possibility by swapping our training and transfer tasks .


During pretesting , participants verbally estimated the metric distances between themselves and targets , or they threw a beanbag to targets .


During training , participants donned goggles that distorted their vision .


While wearing the goggles , they threw a beanbag to targets .


Half received feedback .


During posttesting , participants removed the distorting goggles and completed the same task that they performed during pretesting .


The results indicated that the distorting goggles degraded throwing at the beginning of training , visual feedback improved throwing during training , the effects of training with feedback persisted into the throwing posttest , and the effects of training with feedback did not transfer to the verbal metric estimation posttest .


Training involving throwing was effective , but did not transfer to verbal metric distance estimation .


This supports our argument that the negative transfer observed in our previous study stemmed from cognitive intrusion .


The present experiment suggests that the creation of distance estimation training should begin with a careful analysis of the transfer task , and that distance estimation training programs should explicitly teach trainees that their training will not generalize to all distance estimation tasks .


Daily application of oral chlorhexidine gluconate ( CHX ) following intubation to reduce the risk of ventilator-associated pneumonia ( VAP ) is now the standard of care in many ICUs .


This randomized clinical trial evaluated the benefit of adding a preintubation CHX dose to the known benefit of postintubation CHX to reduce the risk of early-onset VAP .


A secondary aim was to test the effect of a preintubation oral application of CHX on early endotracheal tube ( ETT ) colonization .


Subjects ( N = @ ) were recruited from two teaching hospitals and were randomly assigned to oral application of @ mL CHX @ % solution before intubation ( intervention group , n = @ ) , or to a control group ( n = @ ) who received no CHX before intubation .


All subjects received CHX bid after intubation .


Groups were compared using a repeated-measures model with Clinical Pulmonary Infection Score ( CPIS ) as the response variable .


In a planned subset of subjects , ETTs were cultured at extubation .


Application of a preintubation dose of CHX did not provide benefit over the intervention period beyond that afforded by daily oral CHX following intubation .


ETT colonization at extubation was < @ % in both groups ( no statistically significant difference ) .


Mean CPIS remained below @ ( VAP threshold score ) in both groups .


Although it is feasible to deliver CHX prior to intubation ( including emergent or urgent intubation ) , the results suggest that preintubation CHX may be inconsequential when the ventilator bundle , including daily oral CHX , is in place .


During the preintubation period , providers should focus their attention on other critical activities .


Linagliptin is a novel , highly selective and long acting DPP-@ inhibitor for the treatment of type @ diabetes mellitus ( T@DM ) .


Linagliptin exhibits non-linear pharmacokinetics ( PK ) due to saturable binding to plasma and tissue DPP-@ .


The aim of this study was to characterize the PK and PK/DPP -@ inhibition relationship of linagliptin in Japanese patients with T@DM using a population PK/DPP -@ model and to support the rationale for the therapeutic dose in Japanese patients by simulation .


Linagliptin plasma concentration and DPP-@ inhibition measurements from a placebo-controlled , parallel group multiple ( @ days ) dose trial that included @ T@DM patients ( @ patients each in @ mg and @ mg dose group ) were used for analysis .


Modeling was performed using FOCE INTERACTION estimation method implemented in NONMEM V.


The linagliptin plasma concentration - and DPP-@ inhibition - time profiles were simulated for Japanese patients receiving @ mg linagliptin once daily by the model established .


Nonlinear PK of linagliptin in T@DM patients were well described by a @-compartment model assuming concentration-dependent binding to DPP-@ in the central and peripheral compartment .


Plasma DPP-@ inhibition was integrated in the model by relating the model-predicted DPP-@ occupancy with linagliptin linearly to DPP-@ inhibition .


The simulation predicted that for the @ mg dose group the trough DPP-@ inhibition at steady-state was @ % , which is higher than the target inhibition ( @ % ) for an effective dose of DPP-@ inhibitor .


In @ mg dose group , steady-state DPP-@ inhibition of > @ % was not maintained over @ hours ( observed and simulated ) .


The nonlinear PK of linagliptin and its plasma DPP-@ inhibition in patients were well characterized by a target-mediated drug disposition model relating DPP-@ occupancy with linagliptin to DPP-@ inhibition .


Simulations of plasma DPP-@ inhibition suggest that @ mg linagliptin once daily is an appropriate therapeutic dose for Japanese patients with T@DM .


To compare the difference in the clinical efficacy on premature ovarian failure ( POF ) between the acupoint catgut implantation combined with artifical periodic therapy and the simple artificial periodic therapy and explore its effect mechanism .


Sixty-five patients of POF were randomized into the two groups .


In a western medication group , @ cases were treated with the artificial periodic therapy with the oral administration of medroxyprogesterone acetate tablets .


In a catgut implantation + western medication group , @ cases were treated with the acupoint catgut implantation combined with artificial periodic therapy .


The acupoints of Neiguan ( PC @ ) , Zusanli ( ST @ ) , Guanyuan ( CV @ ) and Sanyinjiao ( SP @ ) were selected .


The treatment was lasted for half a year and the follow-up visit was for another half a year in the two groups .


Kupperman index was used to assess the improvements in the clinical symptoms .


The levels of serum sexual hormones such as follicle stimulating hormone ( FSH ) and estradiol ( E@ ) were evaluated of the patients in the two groups before and after treatment .


The efficacy was compared between the two groups .


The scores of the clinical symptoms were all significantly improved after treatment and in the follow-up in the two groups ( P < @ , P < @ ) .


In the @-month follow-up visit after treatment , the result in the catgut implantation + western medication group was better than that in the western medication group ( @ + / - @ vs @ + / - @ , P < @ ) .


FSH was reduced after treatment in the two groups ( all P < @ ) and E@ was increased ( all P < @ ) .


The curative and remarkably effective rates were @ % ( @/@ ) and @ % ( @/@ ) after treatment and in the follow-up visit in the catgut implantation + western medication group , which were better than @ % ( @/@ ) and @ % ( @/@ ) in the western medication group separately ( P < @ , P < @ ) .


The acupoint catgut implantation combined with artificial periodic therapy achieve the remarkable improvements in the clinical symptoms of POF in the patients and the better results as compared with the simple western medication therapy .


The combined therapys efficacy is stable and the long-term efficacy is apparently superior .


The effect mechanism is related to the improvements in the serum sexual hormone levels .


MicroRNAs have emerged as important epigenetic regulators in cardiovascular diseases ( CVDs ) .


Using an observational meta-analysis design , we previously characterized a gain-of-function microRNA-@ target site polymorphism ( rs@T > C ) in the @ ` untranslated region of the lipoprotein lipase ( LPL ) gene .


The C allele was associated with lower triglycerides , and this association was modulated by fat intake .


We aimed to extend our findings by assessing the interaction between the rs@ polymorphism and fat intake on triglycerides at baseline and longitudinally by using a dietary intervention design .


We also examined as a primary outcome the association of this variant with CVD incidence and its modulation by the Mediterranean diet ( MedDiet ) .


We studied @ participants in the PREDIMED ( Prevencin con Dieta Mediterrnea ) randomized trial that tested a MedDiet intervention compared with a control diet , with a median @-y follow-up .


LPL polymorphisms and triglycerides were determined and CVD assessed .


Gene-diet interactions for triglycerides were analyzed at baseline ( n = @ ) and after a @-y intervention ( n = @ ) .


Oxidative stress parameters were investigated in a subsample .


The rs@T > C polymorphism was strongly associated with lower triglycerides in C allele carriers and interacted synergistically with dietary monounsaturated ( P = @ ) and unsaturated fat intake ( P = @ ) , decreasing triglycerides at baseline .


By @ y , we observed a gene-diet interaction ( P = @ ) in which the C allele was associated with a greater reduction in triglycerides after intervention with MedDiet , high in unsaturated fat .


Although the polymorphism was associated with lower stroke risk ( HR : @ ; @ % CI : @ , @ ; P = @ per C allele ) , this association reached statistical significance only in the MedDiet intervention ( HR : @ ; @ % CI : @ , @ ; P = @ in C compared with TT carriers ) , not in the control group ( HR : @ ; @ % CI : @ , @ ; P = @ ) .


We report a novel association between a microRNA target site variant and stroke incidence , which is modulated by diet in terms of decreasing triglycerides and possibly stroke risk in rs@ C allele carriers after a high-unsaturated fat MedDiet intervention .


Exercise and adequate self-management capacity may be important strategies in the management of venous leg ulcers .


However , it remains unclear if exercise improves the healing rates of venous leg ulcers and if a self-management exercise program based on self-efficacy theory is well adhered to .


This is a randomised controlled in adults with venous leg ulcers to determine the effectiveness of a self-efficacy based exercise intervention .


Participants with venous leg ulcers are recruited from @ clinical sites in Australia .


After collection of baseline data , participants are randomised to either an intervention group or control group .


The control group receive usual care , as recommended by evidence based guidelines .


The intervention group receive an individualised program of calf muscle exercises and walking .


The twelve week exercise program integrates multiple elements , including up to six telephone delivered behavioural coaching and goal setting sessions , supported by written materials , a pedometer and two follow-up booster calls if required .


Participants are encouraged to seek social support among their friends , self-monitor their weekly steps and lower limb exercises .


The control group are supported by a generic information sheet that the intervention group also receive encouraging lower limb exercises , a pedometer for self-management and phone calls at the same time points as the intervention group .


The primary outcome is the healing rates of venous leg ulcers which are assessed at fortnightly clinic appointments .


Secondary outcomes , assessed at baseline and @ weeks : functional ability ( range of ankle motion and Tinetti gait and balance score ) , quality of life and self-management scores .


This study seeks to address a significant gap in current wound management practice by providing evidence for the effectiveness of a home-based exercise program for adults with venous leg ulcers .


Theory-driven , evidence-based strategies that can improve an individual 's exercise self-efficacy and self-management capacity could have a significant impact in improving the management of people with venous leg ulcers .


Information gained from this study will provide much needed information on management of this chronic disease to promote health and independence in this population .


There is evidence from nonrandomized studies that a proportion of ipilimumab-treated patients with advanced melanoma experience long-term survival .


To demonstrate a long-term survival benefit with ipilimumab , we evaluated the @-year survival rates of patients treated in a randomized , controlled phase III trial .


A milestone survival analysis was conducted to capture the @-year survival rate of treatment-naive patients with advanced melanoma who received ipilimumab in a phase III trial .


Patients were randomly assigned @:@ to receive ipilimumab at @ mg/kg plus dacarbazine ( n = @ ) or placebo plus dacarbazine ( n = @ ) at weeks @ , @ , @ , and @ followed by dacarbazine alone every @ weeks through week @ .


Eligible patients could receive maintenance ipilimumab or placebo every @ weeks beginning at week @ .


A safety analysis was conducted on patients who survived at least @ years and continued to receive ipilimumab as maintenance therapy .


The @-year survival rate was @ % ( @ % CI , @ % to @ % ) for patients treated with ipilimumab plus dacarbazine versus @ % ( @ % CI , @ % to @ % ) for patients treated with placebo plus dacarbazine ( P = @ ) .


A plateau in the survival curve began at approximately @ years .


In patients who survived at least @ years and continued to receive ipilimumab , grade @ or @ immune-related adverse events were observed exclusively in the skin .


The additional survival benefit of ipilimumab plus dacarbazine is maintained with twice as many patients alive at @ years compared with those who initially received placebo plus dacarbazine .


These results demonstrate a durable survival benefit with ipilimumab in advanced melanoma .


Urinary retention is one of the most common complications contributing to surgical procedures .


Recent studies have shown the benefits of alpha-adrenergic blockers in preventing post-operative urinary retention ( POUR ) .


The aim of this prospective study was to compare the prophylactic effect of tamsulosin with placebo on postoperative urinary retention .


In this randomized placebo controlled , clinical trial , @ male patients aged @ to @ years old admitted to Razi University Hospital for varicocelectomy , inguinal herniorrhaphy , and scrotal surgery were randomly assigned to receive either three doses of @ mg tamsulosin ( n = @ ) or placebo ( n = @ ) , @ and @ hours before , and @ hours after surgery .


Patients were closely monitored for the development of urinary retention @ hours after surgical intervention .


The primary endpoint was to investigate the effect of tamsulosin in prevention of post-operative urinary retention during the first @ hours after surgical intervention .


Collected data were analyzed using SPSS software version @ and the P < @ was considered statistically significant .


One hundred and eighteen patients were included in tamsulosin arm and @ in placebo arm .


POUR in patients who received tamsulosin was significantly lower than placebo , as @ % of the patients treated with tamsulosin and @ % placebo group , reported urinary retention following surgery ( P = @ ) .


No serious adverse effects were seen in both groups .


This study suggests that short perioperative treatment with tamsulosin can reduce the incidence of urinary retention and the need for catheterization after varicocelectomy , inguinal herniorrhaphy , and scrotal surgery .


Inflammatory bowel disease ( IBD ) is a chronic condition with an unpredictable disease course .


Rates of anxiety and depression among IBD patients in relapse ( active disease symptoms ) as well as in remission are higher than in the general population .


Previous studies suggest that the prolonged effect of pain , anxiety , distress and depression have a detrimental effect on patients ` quality of life ( QoL ) .


Poor QoL in itself is associated with further symptom relapse .


Mindfulness based cognitive therapy ( MBCT ) is a psychological group intervention that has the potential to improve QoL .


When used in other chronic conditions , it demonstrated reduced negative effect from pain and psychological factors at completion of an @-week MBCT course .


The effect of MBCT has never been researched in IBD .


The aim of this study is to obtain the information required to design a full scale randomised controlled trial ( RCT ) that will examine the effectiveness of MBCT in improving quality of life for IBD patients .


This is an exploratory RCT with embedded process evaluation .


Forty IBD patients will be recruited from NHS outpatient gastroenterology clinics and will be randomised to either a MBCT ( intervention ) group or to a wait-list ( control ) group .


All participants will undergo @ h of structured group training over an @-week period , with the control group starting @ months later than the intervention group .


Primary outcomes are recruitment , completion/retention rates and adherence and adaptation to the MBCT manual for IBD patients .


The secondary outcome is to assess the feasibility of collecting reliable and valid data on proposed outcome measures such as quality of life , anxiety , depression , disease activity and mindful awareness .


The process evaluation will use a survey and focus groups to assess the acceptability of the intervention and trial procedures for IBD patients .


The outcomes of this study will help define the barriers , uptake and perceived benefits of MBCT program for IBD patients .


This information will enable the design of a full-scale study assessing the effect of MBCT on quality of life for IBD patients .


General anesthesia usually requires mechanical ventilation , which is traditionally accomplished with constant tidal volumes in volume - or pressure-controlled modes .


Experimental studies suggest that the use of variable tidal volumes ( variable ventilation ) recruits lung tissue , improves pulmonary function and reduces systemic inflammatory response .


However , it is currently not known whether patients undergoing open abdominal surgery might benefit from intraoperative variable ventilation .


The PROtective VARiable ventilation trial ( ` PROVAR ' ) is a single center , randomized controlled trial enrolling @ patients who are planning for open abdominal surgery expected to last longer than @hours .


PROVAR compares conventional ( non-variable ) lung protective ventilation ( CV ) with variable lung protective ventilation ( VV ) regarding pulmonary function and inflammatory response .


The primary endpoint of the study is the forced vital capacity on the first postoperative day .


Secondary endpoints include further lung function tests , plasma cytokine levels , spatial distribution of ventilation assessed by means of electrical impedance tomography and postoperative pulmonary complications .


We hypothesize that VV improves lung function and reduces systemic inflammatory response compared to CV in patients receiving mechanical ventilation during general anesthesia for open abdominal surgery longer than @hours .


PROVAR is the first randomized controlled trial aiming at intra - and postoperative effects of VV on lung function .


This study may help to define the role of VV during general anesthesia requiring mechanical ventilation .


To evaluate visual function in patients with symptomatic vitreomacular adhesion ( VMA ) / vitreomacular traction including when associated with macular hole after ocriplasmin treatment , and the association between resolution of the underlying condition and improvement in visual function .


Six hundred and fifty-two patients from @ Phase @ trials received a single intravitreal injection of ocriplasmin @ g ( n = @ ) or placebo ( n = @ ) .


Mean and categorical changes from baseline in best-corrected visual acuity and @-item Visual Function Questionnaire scores were used to evaluate visual function .


Subgroups with VMA resolution and full-thickness macular hole closure were compared .


Overall , @ % of patients who achieved VMA resolution at Day @ had a @-line improvement in best-corrected visual acuity at Month @ , and @ % had a @-line improvement .


Likewise , @ % of patients with nonsurgical full-thickness macular hole closure at Day @ had a @-line improvement at Month @ , and @ % had a @-line best-corrected visual acuity improvement .


Mean improvements in @-item Visual Function Questionnaire scores were associated with achieving VMA resolution and nonsurgical full-thickness macular hole closure .


In patients with symptomatic VMA/vitreomacular traction , VMA resolution and nonsurgical full-thickness macular hole closure were each associated with improvements in visual function .


Resolving the underlying anatomical condition in symptomatic VMA/vitreomacular traction will increase the probability of achieving a clinically meaningful improvement in visual function .


It is well established in the literature that regular participation in physical activity is effective for chronic disease management and prevention .


Remote monitoring technologies ( ie , mHealth ) hold promise for engaging patients in self-management of many chronic diseases .


The purpose of this study was to test the effectiveness of an mHealth study with tailored physical activity prescription targeting changes in various intensities of physical activity ( eg , exercise , sedentary behavior , or both ) for improving physiological and behavioral markers of lifestyle-related disease risk .


Forty-five older adults ( aged @-@ years ; mean age @ @ years ) were randomly assigned to receive a personal activity program targeting changes to either daily exercise , sedentary behavior , or both .


All participants received an mHealth technology kit including smartphone , blood pressure monitor , glucometer , and pedometer .


Participants engaged in physical activity programming at home during the @-week intervention period and submitted physical activity ( steps/day ) , blood pressure ( mm Hg ) , body weight ( kg ) , and blood glucose ( mmol/L ) measures remotely using study-provided devices .


There were no differences between groups at baseline ( P > @ ) .


The intervention had a significant effect ( F ( @ @ ) = @ , P = @ , P = @ ) , with similar changes across all groups for physical activity , body weight , and blood pressure ( P > @ ) .


Changes in blood glucose were significantly different between groups , with groups prescribed high-intensity activity ( ie , exercise ) demonstrating greater reductions in blood glucose than the group prescribed changes to sedentary behavior alone ( P < @ ) .


Findings demonstrate the utility of pairing mHealth technologies with activity prescription for prevention of lifestyle-related chronic diseases among an at-risk group of older men and women .


RESULTS support the novel approach of prescribing changes to sedentary behaviors ( alone , and in conjunction with exercise ) to reduce risk of developing lifestyle-related chronic conditions .


To examine the feasibility of collecting data relating to irritable bowel syndrome ( IBS ) , symptoms by short message service ( SMS ) text and explore the data to assess its usefulness .


In a randomized parallel group design substudy , @ consenting participants recruited from primary care to a trial of acupuncture for IBS ( ISRCTN @ ) were randomized to receive a one-question SMS message at either @:@ am or at @:@ pm for @days : `` On a scale of @-@ , with @ being no symptoms and @ being the worst symptoms you could have , how would you score your IBS symptoms now ?


Please text back a single number . ''


Of the total messages , @ % ( n = @ ) were answered within @minutes , @ % ( n = @ ) within @hour , and @ % ( n = @ ) within @hours .


Response rates to evening texts were higher ( @ % vs. @ % P = @ ) and response times shorter though not significantly ( median : @ vs. @hours ; P = @ ) .


There was no difference in mean scores , and morning symptoms varied more .


Mean scores correlated significantly with IBS trial primary outcome measure , the IBS symptom severity score , and secondary outcome measures .


Among IBS trial participants , data collection by SMS is feasible and acceptable , and there is potential for deriving meaningful data from the scores .


Keratosis pilaris ( KP ) is a common skin disorder of follicular prominence and erythema that typically affects the proximal extremities , can be disfiguring , and is often resistant to treatment .


Shorter-wavelength vascular lasers have been used to reduce the associated erythema but not the textural irregularity .


To determine whether the longer-wavelength @-nm diode laser may be effective for treatment of KP , particularly the associated skin roughness/bumpiness and textural irregularity .


We performed a split-body , rater-blinded , parallel-group , balanced ( @:@ ) , placebo-controlled randomized clinical trial at a dermatology outpatient practice of an urban academic medical center from March @ to October @ , @ .


We included all patients diagnosed as having KP on both arms and Fitzpatrick skin types I through III .


Of the @ patients who underwent screening , @ met our enrollment criteria .


Of these , @ patients completed the study , @ were lost to or unavailable for follow-up , and @ withdrew owing to inflammatory hyperpigmentation after the laser treatment .


Patients were randomized to receive laser treatment on the right or left arm .


Each patient received treatment with the @-nm pulsed diode laser to the arm randomized to be the treatment site .


Treatments were repeated twice , for a total of @ treatment visits spaced @ to @ weeks apart .


The primary outcome measure was the difference in disease severity score , including redness and roughness/bumpiness , with each graded on a scale of @ ( least severe ) to @ ( most severe ) , between the treated and control sites .


Two blinded dermatologists rated the sites at @ weeks after the initial visit .


At follow-up , the median redness score reported by the @ blinded raters for the treatment and control sides was @ ( interquartile range -LSB- IQR -RSB- , @-@ ; P = @ ) .


The median roughness/bumpiness score was @ ( IQR , @-@ ) for the treatment sides and @ ( IQR , @-@ ) for the control sides , a difference of @ ( P = @ ) .


The median overall score combining erythema and roughness/bumpiness was @ ( IQR , @-@ ) for the treatment sides and @ ( IQR , @-@ ) for the control sides , a difference of @ ( P = @ ) .


Three treatments with the @-nm diode laser may induce significant improvements in skin texture and roughness/bumpiness in KP patients with Fitzpatrick skin types I through III , but baseline erythema is not improved .


Complete treatment of erythema and texture in KP may require diode laser treatment combined with other laser or medical modalities that address redness .


To determine the association between nonalcoholic fatty liver disease ( NAFLD ) and the presence of high-risk coronary atherosclerotic plaque as assessed with coronary computed tomographic ( CT ) angiography .


This study was approved by the local ethics committees ; informed consent was obtained .


Patients randomized to the coronary CT angiography arm of the Rule Out Myocardial Infarction using Computer Assisted Tomography , or ROMICAT , II trial who underwent both nonenhanced CT to assess calcium score and contrast material-enhanced coronary CT angiography were included .


Readers assessed coronary CT angiography images for the presence of coronary plaque , significant stenosis ( @ % ) , and high-risk plaque features ( positive remodeling , CT attenuation < @ HU , napkin-ring sign , spotty calcium ) .


NAFLD was defined as hepatic steatosis at nonenhanced CT ( liver minus spleen CT attenuation < @ HU ) without evidence of clinical liver disease , liver cirrhosis , or alcohol abuse .


To determine the association between high-risk plaque and NAFLD , univariable and multivariable logistic regression analyses were performed , with high-risk plaque as a dependent variable and NAFLD , traditional risk factors , and extent of coronary atherosclerosis as independent variables .


Overall , @ ( @ % ) of @ patients had CT evidence of NAFLD .


High-risk plaque was more frequent in patients with NAFLD than in patients without NAFLD ( @ % vs @ % , respectively ; P < @ ) .


The association between NAFLD and high-risk plaque ( odds ratio , @ ; @ % confidence interval : @ , @ ) persisted after adjusting for the extent and severity of coronary atherosclerosis and traditional risk factors .


NAFLD is associated with advanced high-risk coronary plaque , independent of traditional cardiovascular risk factors and the extent and severity of coronary artery disease .


Bioimpedance analysis ( BIA ) is well established to assess body composition .


Agreements between single - and multi-frequency bioimpedance ( SF-BIA , MF-BIS ) measurements in subjects undergoing @ or @ times/week hemodialysis ( HD ) were analyzed .


Total body water ( TBW ) and intra - and extracellular fluid ( ICF , ECF ) of subjects enrolled in the Frequent Hemodialysis Network ( FHN ) Daily Trial ( www.clinicaltrials.gov No .


NCT@ ) were measured with a Hydra @ at baseline ( BL ) and at @ months ( M@ ) .


Volumes were computed using SF ( at @ kHz ) and MF approaches .


Agreement was assessed by means of linear regression and Bland-Altman analysis and treatment effects by t test .


@ subjects ( @ on the more frequent regimen , @ males , @ African-American , @ @ years , pre-HD weight @ @ kg ) were studied .


Assessments with SF-BIA and MF-BIS correlated significantly at BL and M@ in both arms .


No proportional errors , but systematic biases over the entire range of values were found at BL and M@ .


Agreement did not differ between subjects randomized to either HD treatment arm at both time points .


MF-BIS appears to have better precision than SF-BIA allowing the observation of a significant treatment effect by the intervention -LSB- -@ ( @ % CI -@ to -@ ) l -RSB- on ECF , not found for ECF SF-BIA .


Precision also affected the statistical power of the SF-BIA data in the current analysis .


Both methods showed agreement without significant proportional errors regardless of HD frequency and can be used for longitudinal analyses .


SF-BIA has lower precision which needs thorough consideration in the design of future trials with similar outcomes .


To determine the efficacy of chest compression accompanied by a @-cmH@O increase in baseline inspiratory pressure on pressure support ventilation , in comparison with that of aspiration alone , in removing secretions , normalizing hemodynamics , and improving respiratory mechanics in patients on mechanical ventilation .


This was a randomized crossover clinical trial involving patients on mechanical ventilation for more than @ h in the ICU of the Porto Alegre Hospital de Clnicas , in the city of Porto Alegre , Brazil .


Patients were randomized to receive aspiration alone ( control group ) or compression accompanied by a @-cmH@O increase in baseline inspiratory pressure on pressure support ventilation ( intervention group ) .


We measured hemodynamic parameters , respiratory mechanics parameters , and the amount of secretions collected .


We included @ patients .


The mean age was @ @ years .


In comparison with the control group , the intervention group showed a higher median amount of secretions collected ( @ g vs. @ g ; p = @ ) , a greater increase in mean expiratory tidal volume ( @ @ mL vs. @ @ mL ; p = @ ) , and a greater increase in mean dynamic compliance ( @ @ cmH@O vs. @ @ cmH@O ; p = @ ) .


In this sample , chest compression accompanied by an increase in pressure support significantly increased the amount of secretions removed , the expiratory tidal volume , and dynamic compliance .


( ClinicalTrials.gov Identifier : NCT@ -LSB- http://www.clinicaltrials.gov/] ) .


This study aimed to evaluate the effectiveness of multi-disciplinary treatment approaches in reducing neurological disabilities in premature infants .


A total of @ infants who were born premature in our hospital between March @ and February @ but had no congenital malformations and no severe neonatal complications , were enrolled in this study .


They were randomly allocated to a multi-disciplinary treatment group ( n = @ ) and a control group ( n = @ ) .


While patients in the control group underwent an early conventional treatment , those in the multi-disciplinary treatment group were subjected to regular development monitoring , neurological examination and screening for brain injury , neuro-nutrition and neurodevelopment therapies , and rehabilitation training .


The incidence rates of abnormalities in posture , reflex , sleep , muscle tone and EEG were significantly lower in the multi-disciplinary treatment group than in the control froup ( P < @ ) at corrected postnatal ages of @-@ months .


At corrected postnatal ages of @ , @ , @ and @ months , both mental development index ( MDI ) and psychomotor development index ( PDI ) scores were significantly higher in the multi-disciplinary treatment group than in the control group ( P < @ ) .


At corrected postnatal age of @ years , incidence rates of cerebral palsy , language barrier , abnormal muscle tone and hearing impairment were significantly lower in the multi-disciplinary treatment group than in the control group ( P < @ ) .


Early multi-disciplinary intervention approaches may significantly improve mental and motor developments and reduce the incidence of cerebral palsy-associated neurological disabilities in premature infants .


Enhanced muscle strength is seen when resistance exercise is combined with the consumption of nutritional supplements .


Although there is a limited number of studies available about the efficacy of gamma oryzanol supplementation with resistance exercise in humans , but its usage as a nutritional supplement for strength is common in athletes .


The aim of this study was to determine the effects of gamma oryzanol supplementation during @-week resistance training on muscular strength and anthropometric measurements of young healthy males .


In this double-blind clinical trial , changes of anthropometric measurements and muscular strength were studied after chronic resistance exercise and gamma oryzanol supplementation in @ healthy volunteers ( @ in supplement and @ in placebo ) .


Each day , gamma oryzanol supplement ( @ mg ) and placebo ( the same amount of lactose ) were consumed after training .


The participants exercised with @ per cent @-Repetition Maximum ( @-RM ) , for one hour and four days/week .


Anthropometric measurements and subjects ' @-RM for muscular strength were determined at the commencement and end of the @-week study .


There was no significant difference between the baseline characteristics and target variables at baseline between the two groups .


After gamma oryzanol supplementation , there was no significant difference in the means of anthropometric and skin fold measurements between the supplement and placebo groups .


However , there were significant differences between the supplement and placebo groups for @-RM of bench press and leg curl , which showed that gamma oryzanol improved muscle strength following resistance training .


Our findings indicated that @ mg/day gamma oryzanol supplementation during the @-week resistance training did not change anthropometric and body measurements , but it increased muscular strength in young healthy males .


Further , studies need to be done in trained athletes , women , and in patients who suffer from muscular fatigue .


Bifurcation lesions are frequent among patients with symptomatic coronary disease treated by percutaneous coronary intervention .


Current evidence recommends a conservative ( provisional ) approach when treating the side branch ( SB ) .


The TRYTON ( Prospective , Single Blind , Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries ) bifurcation trial sought to compare treatment of de novo true bifurcation lesions using a dedicated bifurcation stent or SB balloon angioplasty .


We randomly assigned patients with true bifurcation lesions to a main vessel stent plus provisional stenting or the bifurcation stent .


The primary endpoint ( powered for noninferiority ) was target vessel failure ( TVF ) ( cardiac death , target vessel myocardial infarction , and target vessel revascularization ) .


The secondary angiographic endpoint ( powered for superiority ) was in-segment percent diameter stenosis of the SB at @ months .


We randomized @ patients with bifurcation coronary lesions at @ centers ( @ from Europe and @ from the United States ) .


At @ months , TVF was @ % in the bifurcation stent group compared with @ % in the provisional group ( p = @ ) , mainly because of a higher periprocedural myocardial infarction rate ( @ % vs. @ % , p = @ ) .


The TVF difference of +@ % ( @-sided @ % confidence interval : -@ to @ ; upper limit of the @-sided @ % confidence interval : @ ) was not within the pre-specified noninferiority margin of @ % ( p = @ for noninferiority ) .


The SB in-segment diameter stenosis among the angiographic cohort was lower in the bifurcation stent group compared with the provisional group ( @ % vs. @ % , p = @ for superiority ) , with no difference in binary restenosis rates ( diameter stenosis@ % ) at @ months follow-up ( @ % vs. @ % , p = @ ) .


Provisional stenting should remain the preferred strategy for treatment of non-left main true coronary bifurcation lesions .


( Prospective , Single Blind , Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries -LSB- TRYTON -RSB- ; NCT@ ) .


Individuals with physical disabilities experience disparities in obesity ; yet few interventions have incorporated accommodations necessary for weight loss in this population .


This project compared the effectiveness of two weight loss interventions among individuals with physical disabilities .


Adults with physical disabilities who were overweight or obese were randomized across two diet approaches : a modified version of the MyPlate diet ( usual care ( UC ) ) and a modified Stoplight Diet ( SLDm ) supplemented with portion-controlled meals .


Project staff met monthly with each participant to measure weight , @-recalls of diet intake , self-tracking of foods and beverages , and physical activity during the preceding month .


Of @ enrollees , @ % completed the initial @-month diet phase and @ % of these completed a @-month follow-up phase .


Participants in the SLDm group reduced weight and BMI during the @ month intervention , and maintained or lost more weight during the @ month maintenance period .


Alternately , the UC diet resulted in a reduction in weight and BMI only at @ months .


BMI from baseline was significantly more improved for SLDm than UC and , among those who lost weight , the SLDm group lost more weight at @ and @ months .


These results demonstrate that interventions with proper design and accommodations can overcome the barriers to weight loss unique to individuals with mobility impairments with low income .


Additionally , the results suggest that using portion control may be more effective than teaching portion sizes .


Previous studies have reported that obese people with trisomy @ suffer from low-grade systemic inflammation .


A recent study has found that aerobic training reduced inflammation in obese women with Down syndrome .


To the best of our knowledge , the study reported in this paper is the first to determine for how long these effects were maintained after completion of the programme .


Twenty premenopausal obese women ( @-@ years old ) with Down syndrome volunteered for this study .


Eleven were randomly assigned to the intervention group and performed a @-week aerobic training programme , @ sessions per week , consisting of warming-up followed by treadmill exercise ( @-@ min ) at a work intensity of @-@ % of peak heart rate and a cooling-down period .


The control group included @ , age , sex and BMI matched women with Down syndrome that did not perform any training programme .


Fat mass percentage and distribution were measured .


Plasma level of IL-@ and high-sensitive C-reactive protein ( hs-CRP ) were monitored .


Time-course changes for these outcomes were assessed at pre - and post-intervention .


Further , they were re-evaluated at @ , @ and @ months after completion of the programme .


Three months after completion of the programme , plasma levels of IL-@ and hs-CRP were significantly increased .


Up to @ months later , both fat mass percentage and waist circumference ( WC ) were significantly increased .


Furthermore , physical fitness was also impaired in the intervention group .


No changes were observed in the control group .


A @-month detraining period significantly impaired chronic inflammation in obese women with DS .


Physicians are a commonly targeted group in health research surveys , but their response rates are often relatively low .


The goal of this paper was to evaluate the effect of unconditional incentives in the form of a coffee card on physician postal survey response rates .


Following @ key informant interviews and eight cognitive interviews a survey questionnaire was developed .


A random sample of @ physicians , stratified by physician group ( geriatricians , family physicians , emergency physicians ) was selected from a national medical directory .


Using computer generated random numbers ; half of the physicians in each stratum were allocated to receive a coffee card to a popular national coffee chain together with the first survey mailout .


The intervention was a $ @ Tim Hortons gift card given to half of the physicians who were randomly allocated to receive the incentive .


@ ( @ % ) physicians completed the survey .


The response rate was significantly higher in the group allocated to receive the incentive ( @ % vs @ % in the control group ; p = @ ) .


Our results indicate that an unconditional incentive in the form of a coffee gift card can substantially improve physician response rates .


Future research can look at the effect of varying amounts of cash on the gift cards on response rates .


In resource-poor settings , cold chain requirements present barriers for vaccine delivery .


We evaluated the immunogenicity and safety of tetanus toxoid ( TT ) vaccine in `` Controlled Temperature Chain '' ( CTC ; up to @ C for < @ days before administration ) , compared to standard cold chain ( SCC ; @-@ C ) .


Prior to the study , stability parameters of TT-CTC were shown to meet international requirements .


A cluster randomized , non-inferiority trial was conducted in Mossala district , Chad , December @-March @ .


Thirty-four included clusters were randomized to CTC or SCC .


Women aged @-@ years , eligible for TT vaccination and with a history of @ TT dose , received two TT doses @ weeks apart .


Participants were blinded to allocation strategy .


Tetanus antibody titers were measured using standard ELISA at inclusion and @ weeks post-TT@ .


Primary outcome measures were post-vaccination seroconversion and fold-increase in geometric mean concentrations ( GMC ) .


Non-inferiority was by seroconversion difference ( TTSCC-TTCTC ) < @ % and ratio of GMCs ( TTSCC/TTCTC ) < @ .


Adverse events were monitored at health centers and at next contact with participants .


A total of @ women ( CTC = @ ; SCC = @ ) were recruited .


Primary intention to vaccinate analysis included @ participants ; @ of these were included in the seroconversion analysis .


Seroconversion was reached by > @ % of participants ; upper @ % CI of the difference was @ % .


Increases in GMC were over @-fold ; upper @ % CI of GMC ratio was @ in the adjusted analysis .


Few adverse events were recorded .


This study demonstrates the immunogenicity and safety of TT in CTC at < @ C for < @ days .


The high proportion of participants protected at baseline results in a reduction of power to detect a @ % non-inferiority margin .


However , results at a @ % non-inferiority margin , the comparable GMC increases and vaccine 's stability demonstrated in the preliminary phase indicate that CTC can be an alternative strategy for TT delivery in situations where cold chain can not be maintained .


Although prevailing spinal nerve involvement has been recognized in a few detailed Guillain-Barr syndrome ( GBS ) autopsy reports , imaging studies addressing this question in cervical nerves are lacking .


We describe clinical , electrophysiological , ultrasonographic ( US ) and pathological findings in six consecutive early GBS patients , evaluated within @ days of onset .


Patients ' ages ranged from @ to @ years .


Five patients required mechanical ventilation , two of them having died @ and @ days after onset .


Upper - and lower-limb nerve US showed abnormal findings in just @ % of scanned peripheral nerves .


In comparison with @ aged-matched control subjects , US of the fifth to seventh cervical nerves showed changes in four cases , which consisted of significant nerve enlargement , blurred boundaries of the corresponding ventral rami , or both .


Autopsy study in one case demonstrated that pathology , consisting of demyelination and endoneurial inflammatory oedema , mainly involved cervical and lumbar nerves .


In early GBS inflammatory oedema of spinal nerves is a pathogenically relevant feature to understanding the mechanism of ascending paralysis , particularly when conventional electrophysiological studies are normal or not diagnostic .


Findings advocate the use of cervical nerve US in early GBS .


AIO KRK-@ investigated first-line therapy of metastatic colorectal cancer ( mCRC ) with cetuximab , capecitabine and irinotecan versus cetuximab , capecitabine and oxaliplatin .


This analysis investigated the impact of primary tumor location on outcome of patients .


Left-sided primary tumors were defined as tumors from rectum to left flexure , while tumors in the remaining colon were regarded right sided .


Overall survival ( OS ) , progression-free survival ( PFS ) and response rate were correlated with primary tumor location .


A Cox regression model was used to evaluate interaction between primary tumor location and KRAS mutation .


Of @ patients of the AIO KRK-@ trial , @ patients presented left-sided ( of those @ KRAS codon @/@ wild-type ) and @ patients right-sided primary tumors ( of those @ KRAS codon @/@ wild-type ) .


Left-sided tumors were associated with significantly longer OS ( p = @ , HR = @ ) and PFS ( p = @ , HR = @ ) as compared to right-sided tumors .


These effects were present in the KRAS codon @/@ wild-type population ( HR OS : @ ; HR PFS : @ ) , while no impact of primary tumor location was evident in patients with KRAS codon @/@ mutant tumors ( HR OS : @ ; HR PFS : @ ) .


A significant interaction of KRAS status and primary tumor location concerning OS and PFS was observed .


Our findings suggest that primary tumor location and KRAS codon @/@ mutational status interact on the outcome of patients with mCRC receiving cetuximab-based first-line therapy .


Left-sided primary tumor location might be a predictor of cetuximab efficacy .


The ideal preparation regimen for pediatric colonoscopy remains elusive , and available preparations continue to represent a challenge for children .


The aim of this study was to compare the efficacy , safety , tolerability , and acceptance of @ methods of bowel cleansing before colonoscopy in children .


This randomized , investigator-blinded , noninferiority trial enrolled all children aged @ to @ years undergoing elective colonoscopy in a referral center for pediatric gastroenterology .


Patients were randomly assigned to receive polyethylene glycol ( PEG ) @ with simethicon ( PEG-ELS group ) or PEG-@ with citrates and simethicone plus bisacodyl ( PEG-CS + Bisacodyl group ) , or PEG @ with ascorbic acid ( PEG-Asc group ) , or sodium picosulfate plus magnesium oxide and citric acid ( NaPico + MgCit group ) .


Bowel cleansing was evaluated according to the Boston Bowel Preparation Scale .


The primary end point was overall colon cleansing .


Tolerability , acceptability , and compliance were also evaluated .


Two hundred ninety-nine patients were randomly allocated to the @ groups .


In the per-protocol analysis , PEG-CS + Bisacodyl , PEG-Asc , and NaPico + MgCit were noninferior to PEG-ELS in bowel-cleansing efficacy of both the whole colon ( P = @ ) and colonic segments .


No serious adverse events occurred in any group .


Rates of tolerability , acceptability , and compliance were significantly higher in the NaPico + MgCit group .


Low-volume PEG preparations ( PEG-CS + Bisacodyl , PEG-Asc ) and NaPico + MgCit are noninferior to PEG-ELS in children , representing an attractive alternative to high-volume regimens in clinical practice .


Because of the higher tolerability and acceptability profile , NaPico + MgCit would appear as the most suitable regimen for bowel preparation in children .


We estimated the prevalence and incidence of @ human papillomavirus ( HPV ) types ( @/@/@ / @/@/@ / @/@/@ / @/@/@ / @/@ ) in cervicovaginal swabs , and the attribution of these HPV types in cervical intraepithelial neoplasia ( CIN ) , and adenocarcinoma in situ ( AIS ) , using predefined algorithms that adjusted for multiple-type infected lesions .


A total of @,@ women ages @ to @ years and @,@ women ages @ to @ years were enrolled in the placebo arms of one of three clinical trials of a quadrivalent HPV vaccine .


We estimated the cumulative incidence of persistent infection and the proportion of CIN/AIS attributable to individual carcinogenic HPV genotypes , as well as the proportion of CIN/AIS lesions potentially preventable by a prophylactic @-valent HPV@/@/@ / @/@/@ / @/@/@ vaccine .


The cumulative incidence of persistent infection with @ of the seven high-risk types included in the @-valent vaccine was @ % , @ % , and @ % for women ages @ to @ , @ to @ , and @ to @ years , respectively .


A total of @,@ lesions were diagnosed as CIN or AIS by an expert pathology panel .


After adjusting for multiple-type infected lesions , among women ages @ to @ years , these seven high-risk types were attributed to @ % to @ % of CIN@ , @ % to @ % of CIN@ , @ % to @ % of CIN@ , and @ % to @ % of AIS lesions , respectively .


The other tested types ( HPV@/@/@ / @/@ ) were attributed to @ % to @ % of CIN@ , @ % to @ % of CIN@ , @ % to @ % of CIN@ , and @ % of AIS lesions , respectively .


Approximately @ % or more of CIN@/AIS , > @ % CIN@ , and approximately @ % of CIN@ lesions worldwide are attributed to HPV@/@/@ / @/@/@ / @/@/@ .


If @-valent HPV vaccination programs are effectively implemented , the majority of CIN@ and CIN@ lesions worldwide could be prevented , in addition to approximately one-half of CIN@ .


Maintenance monotherapy with the PARP inhibitor olaparib significantly prolonged progression-free survival ( PFS ) versus placebo in patients with platinum-sensitive recurrent serous ovarian cancer .


We aimed to explore the hypothesis that olaparib is most likely to benefit patients with a BRCA mutation .


We present data from the second interim analysis of overall survival and a retrospective , preplanned analysis of data by BRCA mutation status from our randomised , double-blind , phase @ study that assessed maintenance treatment with olaparib @ mg twice daily ( capsules ) versus placebo in patients with platinum-sensitive recurrent serous ovarian cancer who had received two or more platinum-based regimens and who had a partial or complete response to their most recent platinum-based regimen .


Randomisation was by an interactive voice response system , stratified by time to progression on penultimate platinum-based regimen , response to the most recent platinum-based regimen before randomisation , and ethnic descent .


The primary endpoint was PFS , analysed for the overall population and by BRCA status .


This study is registered with ClinicalTrials.gov , number NCT@ .


Between Aug @ , @ , and Feb @ , @ , @ patients were assigned to olaparib and @ to placebo .


BRCA status was known for @ ( @ % ) patients in the olaparib group versus @ ( @ % ) in the placebo group , of whom @ ( @ % ) versus @ ( @ % ) had a deleterious or suspected deleterious germline or tumour BRCA mutation .


Of patients with a BRCA mutation , median PFS was significantly longer in the olaparib group than in the placebo group ( @ months -LSB- @ % CI @-not calculable -RSB- vs @ months -LSB- @-@ -RSB- ; HR @ -LSB- @-@ -RSB- ; p < @ ) ; similar findings were noted for patients with wild-type BRCA , although the difference between groups was lower ( @ months -LSB- @-@ -RSB- vs @ months -LSB- @-@ -RSB- ; HR @ -LSB- @-@ -RSB- ; p = @ ) .


At the second interim analysis of overall survival ( @ % maturity ) , overall survival did not significantly differ between the groups ( HR @ -LSB- @ % CI @-@ -RSB- ; p = @ ) ; similar findings were noted for patients with mutated BRCA ( HR @ -LSB- @-@ -RSB- ; p = @ ) and wild-type BRCA ( HR @ -LSB- @-@ -RSB- ; p = @ ) .


The most common grade @ or worse adverse events in the olaparib group were fatigue ( in ten -LSB- @ % -RSB- patients in the olaparib group vs four -LSB- @ % -RSB- in the placebo group ) and anaemia ( seven -LSB- @ % -RSB- vs one -LSB- < @ % -RSB- ) .


Serious adverse events were reported in @ ( @ % ) patients who received olaparib and @ ( @ % ) who received placebo .


Tolerability was similar in patients with mutated BRCA and the overall population .


These results support the hypothesis that patients with platinum-sensitive recurrent serous ovarian cancer with a BRCA mutation have the greatest likelihood of benefiting from olaparib treatment .


Lifestyle factors represent prime targets for behaviour change interventions to promote healthy ageing and reduce dementia risk .


We evaluated a goal-setting intervention aimed at promoting increased cognitive and physical activity and improving mental and physical fitness , diet and health .


This was a pilot randomised controlled trial designed to guide planning for a larger-scale investigation , provide preliminary evidence regarding efficacy , and explore feasibility and acceptability .


Primary outcomes were engagement in physical and cognitive activity .


Participants aged over @ living independently in the community were recruited through a community Agewell Centre .


Following baseline assessment participants were randomly allocated to one of three conditions : control ( IC ) had an interview in which information about activities and health was discussed ; goal-setting ( GS n = @ ) had an interview in which they set behaviour change goals relating to physical , cognitive and social activity , health and nutrition ; and goal-setting with mentoring ( GM , n = @ ) had the goal-setting interview followed by bi-monthly telephone mentoring .


Participants and researchers were blinded to group assignment .


Participants were reassessed after @months .


Seventy-five participants were randomised ( IC n = @ , GS n = @ , GM n = @ ) .


At @-month follow-up , the two goal-setting groups , taken together ( GS n = @ , GM n = @ ) , increased their level of physical ( effect size @ ) and cognitive ( effect size @ ) activity relative to controls ( IC n = @ ) .


In secondary outcomes , the two goal-setting groups taken together achieved additional benefits compared to control ( effect sizes@ @ ) in memory , executive function , cholesterol level , aerobic capacity , flexibility , balance , grip strength , and agility .


Adding follow-up mentoring produced further benefits compared to goal-setting alone ( effect sizes@ @ ) in physical activity , body composition , global cognition and memory , but not in other domains .


Implementation of the recruitment procedure , assessment and intervention was found to be feasible and the approach taken was acceptable to participants , with no adverse effects .


A brief , low-cost goal-setting intervention is feasible and acceptable , and has the potential to achieve increased activity engagement .


To investigate the effectiveness of surgical strategies for Shang Ring circumcision in the treatment of short frenulum praeputii in patients with redundant prepuce or phimosis .


Totally , @ cases of short frenulum praeputii with redundant prepuce or phimosis were randomly assigned to an experimental group and a control group of equal number to receive Shang Ring circumcision , the former by transverse incision in the distal penis foreskin and pull-up of the interior board , and the latter by conventional transverse incision and longitudinal suture of the frenulum praeputii .


Comparisons were made between the two groups in the surgical duration , intraoperative blood loss , @ h postoperative pain visual analog score ( VAS ) , postoperative complications , satisfaction with the penile appearance , and the quality of sexual life .


The surgical duration , intraoperative blood loss , @ h postoperative VAS , postoperative sexual satisfaction , and satisfaction with penile appearance were ( @ + / - @ ) min , ( @ + / - @ ) ml , @ + / - @ , @ % , and @ % , respectively , in the experimental group , as compared with ( @ + / - @ ) min , ( @ + / - @ ) ml , @ + / - @ , @ % and @ % in the control , with statistically significant differences between the two groups ( P < @ ) .


The incidence rates of such major complications as wound dehiscence , infection , and moderate to severe edema were @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) , respectively , in the experimental group in comparison with @ % ( @/@ ) , @ % ( @/@ ) , and @ % ( @/@ ) in the control , with statistically significant differences between the two groups ( P < @ ) .


None of patients had any serious complications .


Shang Ring circumcision by transverse incision in the distal penis foreskin and pull-up of the interior board , with its advantages of shorter operation time , less blood loss , mild pain , fewer complications , and higher satisfaction and acceptance of the patients , can be used as an safe and effective approach to the treatment of short frenulum praeputii .


Acotiamide is a first-in-class drug that is used to treat functional dyspepsia ( FD ) .


It is considered that acotiamide acts as an antagonist on muscarinic autoreceptors in the enteric nervous system and inhibits acetylcholinesterase activity .


We examined the effect of acotiamide on gastric emptying in healthy adult humans .


Twelve healthy adult males were enrolled in this double-blind crossover study .


Acotiamide or placebo was administered orally in the @ subjects @min before ingestion of a nutritional liquid meal ( @Kcal/@mL ) .


Six of the @ participants took @mg of acotiamide or placebo , and six of the @ participants took @mg of acotiamide or placebo in a double-blind crossover fashion .


All subjects underwent measurement of gastric emptying by the ( @ ) C breath test .


After the meal with placebo was ingested , the % dose/h curve ascended .


The % dose/h curve after a meal with @ or @mg of acotiamide ascended in an identical manner compared with the results with placebo .


No significant differences were observed at any studied time point , and there were no significant changes in gastric emptying parameters ( gastric emptying coefficient , t-@ / @ex and t-lag ex ) .


A single administration of @ or @mg of acotiamide did not affect gastric emptying after a liquid meal in healthy adult humans .


Acotiamide has profound effects on restoring delayed gastric emptying and impaired accommodation in patients with FD but may have no effect on gastric emptying in healthy subjects .


Such pharmacological actions have not been observed in previous gastroprokinetic studies .


To observe the influence of Qingrehuatan decoction ( QRHT ) on serum metabolic profile in young essential hypertension ( YEH ) patients with abundant phlegm-heat syndrome and provide a basis for treatment with the decoction .


Twelve male YEH patients were randomly selected and serum samples were collected for examination before and after @ weeks of the treatment with QRHT .


Twelve healthy males were randomly selected and their serum samples were collected as a control .


All serum samples were detected using metabolomic technology with @H nuclear magnetic resonance .


Differences in metabolites were studied by principal component analysis and partial least squares-discriminate analysis , which produced scores and loadings plots .


After @ weeks of treatment , serum substances could be distinguished between the YEH patients with abundant phlegm-heat syndrome and the control patients .


The specific serum endog - enous metabolites tended to improve after the treatment .


QRHT can appropriately increase the levels of glucose , lactic acid , citric acid , high-density lipoprotein , phosphatidylcholine , glycerophosphate choline , hydroxybutyrate , alanine , and glutamate .


QRHT could also decrease the levels of low-density lipoprotein/very low-density lipoprotein , lipids , N-acetyl glycoprotein , and O-acetyl glycoprotein .


QRHT can effectively ameliorate metabolic disorders in YEH Patients with abundant phlegm-heat syndrome .


@H NMR-based metabolomic technology can provide an objective basis for the treatment of YEH patients with abundant phlegm-heat syndrome using QRHT .


The EORTC-STBSG coordinated two large trials of adjuvant chemotherapy ( CT ) in localized high-grade soft tissue sarcoma ( STS ) .


Both studies failed to demonstrate any benefit on overall survival ( OS ) .


The aim of the analysis of these two trials was to identify subgroups of patients who may benefit from adjuvant CT. .


Individual patient data from two EORTC trials comparing doxorubicin-based CT to observation only in completely resected STS ( large resection , R@/marginal resection , R@ ) were pooled .


Prognostic factors were assessed by univariate and multivariate analyses .


Patient outcomes were subsequently compared between the two groups of patients according to each analyzed factor .


A total of @ patients had been enrolled with a median follow-up of @ years .


Tumor size , high histological grade and R@ resection emerged as independent adverse prognostic factors for relapse-free survival ( RFS ) and OS .


Adjuvant CT is an independent favorable prognostic factor for RFS but not for OS .


A significant interaction between benefit of adjuvant CT and age , gender and R@ resection was observed for RFS and OS .


Males and patients > @ years had a significantly better RFS in the treatment arms , while adjuvant CT was associated with a marginally worse OS in females and patients < @ years .


Patients with R@ resection had a significantly better RFS and OS favoring adjuvant CT arms .


Adjuvant CT is not associated with a better OS in young patients or in any pathology subgroup .


Poor quality of initial surgery is the most important prognostic and predictive factor for utility of adjuvant CT in STS .


Based on these data , we conclude that adjuvant CT for STS remains an investigational procedure and is not a routine standard of care .


To assess the association between minimum inhibitory concentration ( MIC ) and clinical outcomes in a fungal keratitis clinical trial .


Experimental study using data from a randomized comparative trial .


Of the @ patients enrolled in the trial , we were able to obtain MIC values from @ patients with monocular fungal keratitis .


The Mycotic Ulcer Treatment Trial I was a randomized , double-masked clinical trial comparing clinical outcomes of monotherapy with topical natamycin versus voriconazole for the treatment of fungal keratitis .


Speciation and determination of MIC to natamycin and voriconazole were performed according to Clinical and Laboratory Standards Institute guidelines .


The relationship between MIC and clinical outcome was assessed .


The primary outcome was @-month best spectacle-corrected visual acuity .


Secondary outcomes included @-month infiltrate or scar size ; corneal perforation and/or therapeutic penetrating keratoplasty ; and time to re-epithelialization .


A @-fold increase in MIC was associated with a larger @-month infiltrate or scar size ( @ mm ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ; P < @ ) and increased odds of perforation ( odds ratio , @ ; @ % CI , @-@ @ ; P = @ ) .


No correlation was found between MIC and @-month visual acuity .


For natamycin-treated cases , an association was found between higher natamycin MIC with larger @-month infiltrate or scar size ( @ mm ; @ % CI , @-@ @ ; P < @ ) and increased perforations ( odds ratio , @ ; @ % CI , @-@ @ ; P < @ ) .


Among voriconazole-treated cases , the voriconazole MIC did not correlate with any of the measured outcomes in the study .


Decreased susceptibility to natamycin was associated with increased infiltrate or scar size and increased odds of perforation .


There was no association between susceptibility to voriconazole and outcome .


The aim of this study was to evaluate the effects of topical ropivacaine anesthesia on hemodynamic responses during intubation and extubation of hypertensive patients .


One hundred fifty patients with hypertension ASA II-III were scheduled for noncardiac operations .


Patients were divided into @ groups : a control group receiving @ ml saline , and @ groups receiving topical anesthesia with @ mg lidocaine or @ mg ropivacaine .


Hemodynamic responses , including blood pressure and heart rate ( HR ) , were recorded at baseline ( T@ ) , before intubation ( T@ ) , during tracheal intubation ( T@ ) , @ min after intubation ( T@ ) , upon eye opening on verbal commands ( T@ ) , during tracheal extubation ( T@ ) , and @ min after extubation ( T@ ) .


Patients were injected with urapidil @ mg during intubation and extubation if their systolic blood pressure ( SBP ) was @ mmHg or diastolic blood pressure ( DBP ) was @ mmHg , and esmolol @ mg when HR was @ bpm .


During extubation , the total dosages of urapidil and esmolol were significantly higher in the saline than in the lidocaine or ropivacaine groups , and were significantly lower in the ropivacaine than in the lidocaine group .


At T@ , SBP , SBP , MAP , and HR were lower in the lidocaine and ropivacaine groups than in the saline group , but the differences were not significant .


From T@ to T@ , SBP , DBP , MAP , and HR were significantly lower in the ropivacaine group than in the other @ groups ( P < @ each ) .


Topical lidocaine and ropivacaine anesthesia can effectively reduce hemodynamic responses during intubation , with ropivacaine better at inhibiting hemodynamic changes at emergence in hypertensive patients .


Adalimumab has been shown to be effective and well tolerated in patients with Crohn 's disease .


This analysis reports the results of a cohort of Japanese patients with moderate to severe Crohn 's disease who were evaluated for up to @years to assess the long-term use of adalimumab .


The study consisted of a double-blind part and an open-label part .


Patients were included either in the @-week double-blind , placebo-controlled part of the study followed by a @-week open-label extension or in the open-label part from the beginning or in the event of a flare .


Patients were treated with adalimumab and evaluated for up to @weeks as @ data cohorts : the all-adalimumab cohort ( patients receiving @ injection of adalimumab ) , the @-week follow-up subcohort ( patients who completed @weeks of follow-up after the first adalimumab dose ) , and the dose-escalation subcohort ( patients receiving adalimumab doses that increased to @mg every other week ) .


In the all-adalimumab cohort ( n = @ ) , clinical remission rates were approximately @ % after @weeks of exposure to adalimumab and for the remainder of the study ( @ % , @ % , and @ % for weeks @ , @ , and @ , respectively ) .


An improvement in quality of life was also maintained over the same period .


In the dose-escalation subcohort ( n = @ ) , the clinical remission rate was @ % ( @/@ ) @weeks after dose escalation .


Adalimumab was tolerated , and no deaths were reported .


Adalimumab is effective for maintaining long-term clinical remission in Japanese patients with moderate to severe Crohn 's disease ( NCT@ ) .


Melioidosis , an infectious disease caused by the Gram-negative bacillus Burkholderia pseudomallei , is difficult to cure .


Antimicrobial treatment comprises intravenous drugs for at least @ days , followed by oral drugs for at least @ weeks .


The standard oral regimen based on trial evidence is trimethoprim-sulfamethoxaxole ( TMP-SMX ) plus doxycycline .


This regimen is used in Thailand but is associated with side-effects and poor adherence by patients , and TMP-SMX alone is recommended in Australia .


We compared the efficacy and side-effects of TMP-SMX with TMP-SMX plus doxycycline for the oral phase of melioidosis treatment .


For this multi-centre , double-blind , non-inferiority , randomised placebo-controlled trial , we enrolled patients ( aged @ years ) from five centres in northeast Thailand with culture-confirmed melioidosis who had received a course of parenteral antimicrobial drugs .


Using a computer-generated sequence , we randomly assigned patients to receive TMP-SMX plus placebo or TMP-SMX plus doxycycline for @ weeks ( @:@ ; block size of ten , stratified by study site ) .


We followed patients up every @ months for @ year and annually thereafter to the end of the study .


The primary endpoint was culture-confirmed recurrent melioidosis , and the non-inferiority margin was a hazard ratio ( HR ) of @ .


This study is registered with www.controlled-trials.com , number ISRCTN@ .


We enrolled and randomly assigned @ patients : @ to TMP-SMX plus placebo and @ to TMP-SMX plus doxycycline .


@ patients ( @ % ) in the TMP-SMX plus placebo group and @ patients ( @ % ) in the TMP-SMX plus doxycycline group developed culture-confirmed recurrent melioidosis ( HR @ ; @ % CI @-@ @ ) .


The criterion for non-inferiority was met ( p = @ ) .


Adverse drug reactions were less common in the TMP-SMX plus placebo group than in the TMP-SMX plus doxycycline group ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


Our findings suggest that TMP-SMX is not inferior to TMP-SMX plus doxycycline for the oral phase of melioidosis treatment , and is preferable on the basis of safety and tolerance by patients .


Concomitant genetic alterations could account for transient clinical responses to tyrosine kinase inhibitors of the EGF receptor ( EGFR ) in patients harboring activating EGFR mutations .


We have evaluated the impact of pretreatment somatic EGFR T@M mutations , TP@ mutations , and Bcl-@ interacting mediator of cell death ( BCL@L@ , also known as BIM ) mRNA expression in @ patients with EGFR-mutant non-small-cell lung cancer ( NSCLC ) included in the EURTAC trial ( trial registration : NCT@ ) .


T@M mutations were detected in @ % of patients using our highly sensitive method based on laser microdissection and peptide-nucleic acid-clamping PCR , which can detect the mutation at an allelic dilution of @ in @,@ .


Progression-free survival ( PFS ) to erlotinib was @ months for those with T@M mutations and @ months for those without , whereas among patients receiving chemotherapy , it was @ and @ months , respectively ( P < @ ) .


PFS to erlotinib was @ months for those with high and @ months for those with low/intermediate BCL@L@ expression levels , whereas among chemotherapy-treated patients , it was @ and @ months , respectively ( P = @ ) .


Overall survival was @ months for patients with high BCL@L@ expression and @ months for those with low/intermediate BCL@L@ expression ( P = @ ) .


Multivariate analyses showed that erlotinib was a marker of longer PFS ( HR = @ ; P = @ ) , whereas high BCL@L@ expression was a marker of longer PFS ( HR = @ ; P = @ ) and overall survival ( HR = @ ; P = @ ) .


Low-level pretreatment T@M mutations can frequently be detected and can be used for customizing treatment with T@M-specific inhibitors .


BCL@L@ mRNA expression is a biomarker of survival in EGFR-mutant NSCLC and can potentially be used for synthetic lethality therapies .


Adjuvant chemotherapy improves patient survival rates after resection for pancreatic adenocarcinoma , but the optimal duration and time to initiate chemotherapy is unknown .


Patients with pancreatic ductal adenocarcinoma treated within the international , phase III , European Study Group for Pancreatic Cancer-@ ( version @ ) study were included if they had been randomly assigned to chemotherapy .


Overall survival analysis was performed on an intention-to-treat basis , retaining patients in their randomized groups , and adjusting the overall treatment effect by known prognostic variables as well as the start time of chemotherapy .


There were @ patients , of whom @ ( @ % ) received gemcitabine and @ ( @ % ) received fluorouracil ; @ patients ( @ % ) completed all six cycles of chemotherapy ( full course ) and @ patients ( @ % ) completed one to five cycles .


Lymph node involvement , resection margins status , tumor differentiation , and completion of therapy were all shown by multivariable Cox regression to be independent survival factors .


Overall survival favored patients who completed the full six courses of treatment versus those who did not ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; P < @ ) .


Time to starting chemotherapy did not influence overall survival rates for the full study population ( HR , @ ; @ % CI , @ to @ ) .


Chemotherapy start time was an important survival factor only for the subgroup of patients who did not complete therapy , in favor of later treatment ( P < @ ) .


Completion of all six cycles of planned adjuvant chemotherapy rather than early initiation was an independent prognostic factor after resection for pancreatic adenocarcinoma .


There seems to be no difference in outcome if chemotherapy is delayed up to @ weeks , thus allowing adequate time for postoperative recovery .


In acute respiratory failure patients undergoing pressure support ventilation , a short cyclic recruitment maneuver ( Sigh ) might induce reaeration of collapsed lung regions , possibly decreasing regional lung strain and improving the homogeneity of ventilation distribution .


We aimed to describe the regional effects of different Sigh rates on reaeration , strain , and ventilation heterogeneity , as measured by thoracic electrical impedance tomography .


Prospective , randomized , cross-over study .


General ICU of a single university-affiliated hospital .


We enrolled @ critically ill patients intubated and mechanically ventilated with PaO@/FIO@ up to @mm Hg and positive end-expiratory pressure at least @cm H@O ( @ with acute respiratory distress syndrome ) , undergoing pressure support ventilation as per clinical decision .


Sigh was added to pressure support ventilation as a @cm H@O continuous positive airway pressure period lasting @-@ seconds at different rates ( no-Sigh vs @ , @ , and @ Sigh ( s ) / min ) .


All study phases were randomly performed and lasted @ minutes .


In the last minutes of each phase , we measured arterial blood gases , changes in end-expiratory lung volume of nondependent and dependent regions , tidal volume reaching nondependent and dependent lung ( Vtnondep and Vtdep ) , dynamic intratidal ventilation heterogeneity , defined as the average ratio of Vt reaching nondependent/Vt reaching dependent lung regions along inspiration ( VtHit ) .


With Sigh , oxygenation improved ( p < @ vs no-Sigh ) , end-expiratory lung volume of nondependent and dependent regions increased ( p < @ vs no-Sigh ) , Vtnondep showed a trend to reduction , and Vtdep significantly decreased ( p = @ and p < @ vs no-Sigh , respectively ) .


VtHit decreased only when Sigh was delivered at @ / min ( p < @ vs no-Sigh ) , while it did not vary during the other two phases .


Sigh decreases regional lung strain and intratidal ventilation heterogeneity .


Our study generates the hypothesis that in ventilated acute respiratory failure patients , Sigh may enhance regional lung protection .


To investigate the interactive effects between batroxobin and low molecular weight heparin ( LMWH ) in reducing peri-operative blood loss and coagulation function in patients who undergone the total hip replacement surgery .


@ ASA I - III patients received @ @ IU LMWH @ hours preoperatively before undergoing the total hip replacement operation , were randomly divided into two groups : testing group ( Group A , n = @ ) and control group ( Group B , n = @ ) receiving @ U batroxobin or @ mg mannitol @ minutes before incision respectively .


Perioperative blood loss , postoperative @ hours drainage and blood routine test , prothrombin time ( PT ) , activated partial thromboplastin time ( APTT ) and fibrinogen ( FIB ) were measured respectively .


Deep vein thrombosis ( DVT ) were measured through color Doppler B-ultrasound @ days after the operation .


The perioperative blood loss in Group A ( @ ml ) was less than that in Group B ( @ ml ) ( P < @ ) while red blood cell , hemoglobin , red blood cell volume and platelet were decreasing after operation in both groups but no significant difference was found between the two groups ( P > @ ) .


There were no drug-related adverse effects found in the two groups , neither the difference in hospitalization between the two groups ( P > @ ) .