A prespecified secondary objective was to assess treatment effects in an extended RAS analysis that included exons @ , @ , and @ of KRAS and NRAS .


Patients with WT KRAS exon @ tumors were randomly assigned at a one-to-one ratio to panitumumab plus mFOLFOX@ or bevacizumab plus mFOLFOX@ .


The primary end point was progression-free survival ( PFS ) ; secondary end points included overall survival ( OS ) and safety .


Of @ randomly assigned patients , @ received treatment .


In the WT KRAS exon @ intent-to-treat group , PFS was similar between arms ( hazard ratio -LSB- HR -RSB- , @ ; @ % CI , @ to @ ; P = @ ) .


Median OS was @ and @ months in the panitumumab and bevacizumab arms , respectively ( HR , @ ; @ % CI , @ to @ ; P = @ ) .


In the WT RAS subgroup ( WT exons @ , @ , and @ of KRAS and NRAS ) , PFS favored the panitumumab arm ( HR , @ ; @ % CI , @ to @ ; P = @ ) .


Median OS was @ and @ months ( HR , @ ; @ % CI , @ to @ ; P = @ ) in the panitumumab and bevacizumab arms , respectively .


Treatment discontinuation rates because of adverse events were similar between arms .


PFS was similar and OS was improved with panitumumab relative to bevacizumab when combined with mFOLFOX@ in patients with WT KRAS exon @ tumors .


Patients with WT RAS tumors seemed to experience more clinical benefit with anti-epidermal growth factor receptor therapy .


Although effectiveness of web-based interventions on lifestyle changes are recognized , the potential of such programs on metabolic syndrome has not been explored .


We describe the protocol of a randomized controlled trial that aims to determine the feasibility , acceptability , usability , and effectiveness of interactive technology on lifestyle intervention in a population with metabolic syndrome .


This is a two-arm randomized controlled trial .


The study includes @ participants ( n = @ per arm ) who will be recruited via online registration on the study website .


The inclusion criteria are that they should have metabolic syndrome and have access to the Internet .


All participants will receive information on dietary intake and physical activity through the study website .


The intervention group will receive additional resources via the study website including interactive Healthy Heart Profile and calorie restricted diet tailored to the participants .


The primary outcomes are feasibility , acceptability , usability , and the change in metabolic syndrome components .


The secondary outcomes are comparing quality of life , physical activity and food intake among the study arms .


The participants will be followed up to @ months with data collection scheduled at baseline , @ and @ months .


There is a need for developing and evaluating web-based interventions that target people with high risk for cardiovascular diseases .


This study will therefore make an important contribution to this novel field of research and practice .


The purpose of this ongoing randomized study was to assess differences in bone level changes and success rates using implants supporting single crowns in the posterior mandible either with platform matched or platform switched abutments .


Patients aged @ and above , missing at least two teeth in the posterior mandible and with a natural tooth mesial to the most proximal implant site were enrolled .


Randomization followed implant placement .


Definitive restorations were placed after a minimum transgingival healing period of @ weeks .


Changes in crestal bone level from surgery and loading ( baseline ) to @-month post-loading were radiographically measured .


Implant survival and success were determined .


Sixty-eight patients received @ implants in the platform switching group and @ in the other one .


The difference of mean marginal bone level change from surgery to @ months was significant between groups ( p < @ ) .


Radiographical mean bone gain or no bone loss from loading was noted for @ % of the platform switching and @ % of the platform matching implants .


Implant success rates were @ % and @ % , respectively .


Within the same implant system the platform switching concept showed a positive effect on marginal bone levels when compared with restorations with platform matching .


Pronounced nasojugal groove ( tear trough deformity ) is one of the landmarks of aging .


Hyaluronic acid filler can be used for attenuating the nasojugal sulcus but irregular lumpness and overcorrection are common adverse reactions .


We evaluated the effect of Restylane Vital with its specialized injector on volume correction and skin tone of nasojugal groove .


Ten Korean women were enrolled in this study .


Subjects were randomized to be injected a stabilized hyaluronic acid-based gel of nonanimal origin ( NAHSA injector , Restylane Vital , Q-med ) on one side of nasojugal groove , with the other side paired as control .


The treatment was performed in one session .


Outcome assessments included standardized photography , mexameter , and spectrometer for skin tone , global evaluation by blinded investigators , and patients ' self-assessment .


An assessment was made before treatment , immediately after treatment , and @ , @ , and @ months after the treatment .


All patients reported a high degree of satisfaction .


Duration of overall effect varied among the patients .


Correction of the nasojugal groove with a Restylane Vital injector causes minimal tissue trauma and allows exact placement of hyaluronic acid .


Restylane Vital injector offers more predictable results and a lower incidence of adverse effects than more commonly used techniques .


Hyaluronic acid filler intradermal injection with special injector is a safe and effective method for correction of nasojugal groove .


To evaluate the efficacy and safety of acupuncture-moxibustion combined with modified Mojie tablet ( see text ) in the prevention of the recurrence of endometriosis ( EMS ) after laparoscopic surgery .


After laparoscopic surgery , @ cases of EMS were randomized into an acupuncture-moxibustion group , a western medication group , a Chinese medication group and a combined therapy of acupuncture-moxibustion and Chinese medication group ( combined therapy group ) , @ cases in each one .


In the acupuncture-moxibustion group , acupuncture was applied at Xuehai ( SP @ ) , Sanyinjiao ( SP @ ) and Guanyuan ( CV @ ) ; the isolated moxibustion with ginger was used at Guanyuan ( CV @ ) , once a day , twice a week .


In the western medication group , gestrinone was prescribed for oral administration , @ mg , once a day , twice a week .


In the Chinese medication group , the self-prepared Mojie tablet were prescribed for oral administration .


In the combined therapy group , acupuncture , moxibustion and modified Mojie tablet for oral administration were used in combination .


The therapeutic methods were same as the acupuncture-moxibustion group and the Chinese medication group .


Totally , the treatment of @ months was required .


Separately , before treatment , after treatment , in @ months after treatment and in @ months after treatment , EHP-@ score ( endometriosis health profile-@ ) , the abdominal/vaginal ultrasound examination , serum CA@ detection and safety index ( ALT detection ) were compared in patients among @ groups .


In @ and @ months after treatment , the positive rates of EHP-@ score were @ % ( @/@ ) in the combined therapy group and @ % ( @/@ ) in the acupuncture-moxibuston group , which were all lower significantly than @ % ( @/@ ) in the western medication group ( both P < @ ) .


In follow-up stage of @ months after treatment , there was no recurrence case in abdominal lviginal ultrasound examination in the combined therapy group , which was lower than @ % ( @/@ ) in the western medication group ( P < @ ) ; the serum CA@ detection in the combined therapy group did not find any abnormal case , which was lower than @ % ( @/@ ) in the western medication group ( P < @ ) .


At the end of treatment session and in the follow-up stage of @ months after treatment , the abnormal rate of ALT were @ % ( @/@ ) and @ % ( @/@ ) in the western medication group , which were higher than those in any of the rest groups ( P < @ ) .


In the follow-up stage of @ months after treatment , there were @ abnormal cases of ALT in the western medication group , but which was not different significantly as compared with the rest groups ( P > @ ) .


Acupuncture and moxibustion combined with modified Mojie tablet effectively prevent from the recurrence of EMS after laparoscopic surgery and improve the life quality of the patients .


This combined therapy brings less damage on the liver as compared with the western medication of gestrinone and indicates its definite efficacy and safety .


Considering the increasing incidence of chronic kidney disease and the increased use of peritoneal dialysis , we wanted to assess whether the multidisciplinary management of patients in peritoneal dialysis might produce improvement in the quality of patients ' lives when compared to management by a routine team of operators .


Our study observed @ patients on peritoneal dialysis in our Department between @ and @ .


They were randomly assigned to either group A , the routine team which consisted of a nephrologist and a nurse , or group B , a multidisciplinary team comprising several medical specialists , a nurse , a psychologist and a social worker .


Two tests , KDQOL-SF and MMPI-@ , were administered to both groups .


In group B , the number of days of hospitalization and day hospital were more than @ % lower when compared to group A.


The multidisciplinary team achieved better results with the KDQOL-SF test with regards to both emotional and objective dimensions .


The Pearson coefficient between the results of the two questionnaires shows how multidisciplinary management can positively influence the perceived well-being of the patient and his or her adherence to treatment .


In a multidisciplinary team , each operator , in addition to his or her specific role , also contributes to the achievement of the overall objective , namely of ensuring an optimal quality of life to the patient on peritoneal dialysis thereby allowing these patients to continue their professional and social lives .


Changes in pulmonary dynamics following laparotomy are well documented .


Deep breathing exercises , with or without incentive spirometry , may help counteract postoperative decreased vital capacity ; however , the evidence for the role of incentive spirometry in the prevention of postoperative atelectasis is inconclusive .


Furthermore , data are scarce regarding the prevention of postoperative atelectasis in sub-Saharan Africa .


To determine the effect of the use of incentive spirometry on pulmonary function following exploratory laparotomy as measured by forced vital capacity ( FVC ) .


This was a single-center , randomized clinical trial performed at Kamuzu Central Hospital , Lilongwe , Malawi .


Study participants were adult patients who underwent exploratory laparotomy and were randomized into the intervention or control groups ( standard of care ) from February @ to November @ , @ .


All patients received routine postoperative care , including instructions for deep breathing and early ambulation .


We used bivariate analysis to compare outcomes between the intervention and control groups .


Adult patients who underwent exploratory laparotomy participated in postoperative deep breathing exercises .


Patients in the intervention group received incentive spirometers .


We assessed pulmonary function using a peak flow meter to measure FVC in both groups of patients .


Secondary outcomes , such as hospital length of stay and mortality , were obtained from the medical records .


A total of @ patients were randomized ( @ in each arm ) .


The median age in the intervention and control groups was @ years ( interquartile range , @-@ years ) and @ years ( interquartile range , @-@ years ) , respectively .


Men predominated in both groups , and most patients underwent emergency procedures ( @ % in the intervention group and @ % in the control group ) .


Mean initial FVC did not differ significantly between the intervention and control groups ( @ and @ L , respectively ; P = @ -LSB- @ % CI , @-@ @ -RSB- ) .


Although patients in the intervention group tended to have higher final FVC measurements , the change between the first and last measured FVC was not statistically significant ( @ and @ L , respectively ; P = @ -LSB- @ % CI , @-@ @ -RSB- ) .


Likewise , hospital length of stay did not differ significantly between groups .


Overall postoperative mortality was @ % , with a higher mortality rate in the control group compared with the intervention group ( @ % and @ % , respectively ; P = @ -LSB- @ % CI , @-@ @ -RSB- ) .


Education and provision of incentive spirometry for unmonitored patient use does not result in statistically significant improvement in pulmonary dynamics following laparotomy .


We would not recommend the addition of incentive spirometry to the current standard of care in this resource-constrained environment .


To assess the effect of armodafinil on task-related prefrontal cortex activation using functional magnetic resonance imaging ( fMRI ) in patients with obstructive sleep apnea ( OSA ) and excessive sleepiness despite continuous positive airway pressure ( CPAP ) therapy .


This @-week , multicenter , prospective , randomized , double-blind , placebo-controlled , parallel-group study was conducted at five neuroimaging sites and four collaborating clinical study centers in the United States .


Patients were @ right-handed or ambidextrous men and women aged between @ and @ years , with OSA and persistent sleepiness , as determined by multiple sleep latency and Epworth Sleepiness Scale scores , despite effective , stable use of CPAP .


Treatment was randomized ( @:@ ) to once-daily armodafinil @ mg or placebo .


The primary efficacy outcome was a change from baseline at week @ in the volume of activation meeting the predefined threshold in the dorsolateral prefrontal cortex during a @-back working memory task .


The key secondary measure was the change in task response latency .


No significant differences were observed between treatment groups in the primary or key secondary outcomes .


Armodafinil was generally well tolerated .


The most common adverse events ( occurring in more than one patient -LSB- @ % -RSB- ) were headache ( @ % ) , nasopharyngitis ( @ % ) , and diarrhea ( @ % ) .


Armodafinil did not improve fMRI-measured functional brain activation in CPAP-treated patients with OSA and excessive sleepiness .


Antisocial behaviour and adult criminality often have their origins in childhood and are best addressed early in the child 's life using evidence-based treatments such as the ` Incredible Years Parent Programme ' .


However , families with additional risk factors who are at highest risk for poor outcomes do not always make sufficient change while attending such programmes .


Additional support to address barriers and improve implementation of positive parenting strategies while these families attend the Incredible Years Programme may improve overall outcomes.The study aims to evaluate the efficacy of adding a structured home visiting intervention ( Home Parent Support ) to improve outcomes in families most at risk of poor treatment response from the Incredible Years intervention .


This study will inform the design of a larger prospective randomised controlled trial .


A pilot single-blind , parallel , superiority , randomised controlled trial .


Randomisation will be undertaken using a computer-generated sequence in a @:@ ratio to the two treatments arranged in permuted blocks with stratification by age , sex , and ethnicity .


One hundred and twenty six participants enrolled in the Incredible Years Parent Programme who meet the high-risk criteria will be randomly allocated to receive either Incredible Years Parent Programme and Home Parent Support , or the Incredible Years Parent Programme alone .


The Home Parent Support is a @-session structured home visiting intervention provided by a trained therapist , alongside the usual Incredible Years Parent Programme , to enhance the adoption of key parenting skills .


The primary outcome is the change in child behaviour from baseline to post-intervention in parent reported Eyberg Child Behavior Inventory Problem Scale .


This is the first formal evaluation of adding Home Parent Support alongside Incredible Years Parent Programme for families with risk factors who typically have poorer treatment outcomes .


We anticipate that the intervention will help vulnerable families stay engaged , strengthen the adoption of effective parenting strategies , and improve outcomes for both the children and families .


Childhood obesity is a growing concern in Sweden .


Children with overweight and obesity run a high risk of becoming obese as adults , and are likely to develop comorbidities .


Despite the immense demand , there is still a lack of evidence-based comprehensive prevention programmes targeting pre-school children and their families in primary health care settings .


The aims are to describe the design and methodology of the PRIMROSE cluster-randomised controlled trial , assess the relative validity of a food frequency questionnaire , and describe the baseline characteristics of the eligible young children and their mothers .


The PRIMROSE trial targets first-time parents and their children at Swedish child health centres ( CHC ) in eight counties in Sweden .


Randomisation is conducted at the CHC unit level .


CHC nurses employed at the participating CHC received training in carrying out the intervention alongside their provision of regular services .


The intervention programme , starting when the child is @-@months of age and ending at age @ , is based on social cognitive theory and employs motivational interviewing .


Primary outcomes are children 's body mass index and waist circumference at fouryears .


Secondary outcomes are children 's and mothers ' eating habits ( assessed by a food frequency questionnaire ) , and children 's and mothers ' physical activity ( measured by accelerometer and a validated questionnaire ) , and mothers ' body mass index and waist circumference .


The on-going population-based PRIMROSE trial , which targets childhood obesity , is embedded in the regular national ( routine ) preventive child health services that are available free-of-charge to all young families in Sweden .


Of the participants ( n = @ ) , @ intervention and @ control mothers ( @ % ) responded to the validated physical activity and food frequency questionnaire at baseline ( i.e. , before the first intervention session , or , for children in the control group , before they reached @months of age ) .


The food frequency questionnaire showed acceptable relative validity when compared with an @-day food diary .


We are not aware of any previous RCT , concerned with the primary prevention of childhood obesity through sessions at CHC that addresses healthy eating habits and physical activity in the context of a routine child health services programme .


To investigate the effects of lutein supplementation on plasma lutein concentrations and the macular pigment optical density ( MPOD ) in central serous chorioretinopathy ( CSC ) .


In this double-masked placebo-controlled study , @ patients received lutein @ mg/d and @ received placebo .


The plasma lutein concentration and MPOD using autofluorescence spectrometry ( density unit , DU ) were measured at baseline and @ and @ months .


The mean plasma lutein concentrations and MPOD values in the lutein and control groups , respectively , were @ and @ ng/mL and @ and @ DU at baseline ; @ and @ ng/mL and @ and @ DU at @ month ; and @ and @ ng/mL and @ and @ DU at @ months .


The plasma concentration in the lutein group was significantly higher than in controls at @ and @ months ( P < @ for both comparisons ) ; however , the MPOD values did not differ significantly between groups at @ ( P = @ ) or @ months ( P = @ ) .


In patients with a plasma lutein concentration below the mean level in @ age-matched healthy subjects ( mean @ ng/mL ; n = @ in lutein group , n = @ in control group ) , the control MPOD values significantly ( P = @ ) decreased at @ months ( mean baseline , @ DU ; @ months , @ DU ) .


The MPOD in the lutein group remained at the baseline level ( mean baseline , @ DU ; @ months , @ DU ) ( P = @ ) .


The MPOD did not increase in patients with CSC with short-term lutein supplementation ; however , among patients with low plasma lutein , supplemental lutein prevented a decline in MPOD that was observed in control subjects ( www.umin.ac.jp/ctr number , UMIN@ ) .


Fluid therapy is widely used in critically ill patients to restore effective intravascular volume and improve organ perfusion .


Recent studies have questioned the administration of colloid-based solutions , especially if containing hydroxyethyl starch ( HES ) , in different ICU populations ; however , there is still uncertainty on the use of colloids as initial fluid therapy for early resuscitation .


The aim of this study was to investigate the effect of two different resuscitation fluid strategies on the mortality of patients with shock .


In a multicentric ( @ ICUs ) , controlled , open-label trial ( from February @ to August @ ) , the authors randomized patients with signs of acute hypovolemia , defined by the combination of hypotension , evidence of low filling pressures or cardiac index and at least two signs of tissue hypoperfusion ( such as altered consciousness , mottled skin , oliguria , lactate levels > @ mmol/L ) , to received either a colloid - or crystalloid-based therapy .


Both cohorts received maintenance fluids consisting in isotonic crystalloids and albumin in case of severe hypoalbuminemia ( < @ g/dL ) .


Exclusion criteria included previous fluid therapy , pregnancy , brain death , extended burns , chronic hemodialysis or liver disease , known coagulopathy , acute anaphylaxis , dehydration and hypotension due to sedative drugs .


Among the @ eligible patients , @ were eventually randomized in one of the two groups .


The @-day mortality was @ % in the colloid and @ % in the crystalloid group ( P = @ ) .


In the sub-group analysis , similar mortality rates were reported for shock due to hypovolemia , sepsis or trauma .


Also , the use of continuous renal replacement therapy was similar between groups ( @ % vs. @ % , P = @ ) .


There were more days alive without mechanical ventilation or vasopressors during the first @ and @ days and a lower @-day mortality in the colloid group .


These data suggest that mortality was not increased and probably decreased with the use of colloids in different forms of shock requiring early fluid resuscitation .


We discussed herein some methodological issues that may explain the discrepancies of this trial with the other studies developed in the same field .


Cochlear implantation with the aim of hearing preservation for combined electric-acoustic stimulation ( EAS ) is the therapy of choice for patients with residual low-frequency hearing .


Preserved residual acoustic hearing has a positive effect on speech intelligibility in difficult noise conditions .


The goal of this study was to assess speech reception thresholds in various complex noise conditions for patients with EAS in comparison with patients using bilateral cochlear implants ( CI ) .


Speech perception in noise was measured for bilateral CI and EAS patient groups .


A total of @ listeners with normal hearing served as a control group .


Speech reception thresholds ( SRT ) were measured using a closed-set sentence matrix test .


Speech was presented with a single source in frontal position ; noise was presented in frontal position or in a multisource noise field ( MSNF ) consisting of a four-loudspeaker array with independent noise sources .


Modulated speech-simulating noise and pseudocontinuous noise served respectively as interference signal with different temporal characteristics .


The average SRTs in the EAS group were significantly better in all test conditions than those of the group with bilateral CI .


Both user groups showed significant improvement in the MSNF condition compared with the frontal noise condition as a result of bilateral interaction .


The normal-hearing control group was able to use short temporal gaps in modulated noise to improve speech perception in noise ( gap listening ) .


This effect was absent in both implanted user groups .


Patients with combined EAS in one ear and a hearing aid in the contralateral ear show significantly improved speech perception in complex noise conditions compared with bilateral CI recipients .


Patient-reported outcomes ( PROs ) are particularly relevant in influenza vaccine trials in the elderly where reduction in symptom severity could prevent illness-related functional impairment .


To evaluate PROs in people aged @ years receiving two different vaccines .


This was a phase III , randomised , observer-blind study ( NCT@ ) of the AS@-adjuvanted inactivated trivalent split-virion influenza vaccine ( AS@-TIV ) versus non-adjuvanted vaccine ( TIV ) .


Using the FluiiQ questionnaire , symptom ( systemic , respiratory , total ) and life impact ( activities , emotions , relationships ) scores were computed as exploratory endpoints , with minimal important difference ( MID ) in influenza severity between vaccines considered post-hoc as > @ % .


Vaccine efficacy of AS@-TIV relative to TIV in severe influenza ( hospitalisation , complication , most severe one-third of episodes based on the area under the curve for systemic symptom score ) was calculated post-hoc .


The main analyses ( descriptive ) were conducted in the according-to-protocol cohort ( n = @ AS@-TIV , n = @ TIV ) for influenza confirmed by culture or reverse transcriptase polymerase chain reaction .


Mean systemic symptom , total symptom and impact on activities scores were lower with AS@-TIV versus TIV .


Mean respiratory symptom , impact on emotions and impact on relationships scores were similar .


Influenza tended to be less severe with AS@-TIV , but the MID was reached only for impact on activities ( mean @ % ) .


Relative vaccine efficacy in severe influenza was @ % ( @ % CI : @-@ @ ) .


AS@-TIV had advantages over TIV in impact on systemic symptoms and activities as measured by the FluiiQ in elderly people .


Higher efficacy of AS@-TIV relative to TIV was shown for prevention of severe illness .


Dietary patterns characterized by high intakes of fruits and vegetables , whole grains , low-fat dairy products , and low glycemic load have been associated with lower type @ diabetes mellitus ( T@DM ) risk .


In contrast , dietary patterns that include high intakes of refined grains , processed meats , and high amounts of added sugars have been associated with increased T@DM risk .


This randomized , @-period crossover trial compared the effects of dairy and sugar-sweetened product ( SSP ) consumption on insulin sensitivity and pancreatic - cell function in men and women at risk of the development of T@DM who habitually consume sugar-sweetened beverages .


In a randomized , controlled crossover trial , participants consumed dairy products ( @ mL/d @ % milk and @ g/d low-fat yogurt ) and SSPs ( @ mL/d nondiet soda and @ g/d nondairy pudding ) , each for @ wk , with a @-wk washout between treatments .


A liquid meal tolerance test ( LMTT ) was administered at baseline and the end of each period .


Participants were @ % female with a mean age and body mass index of @ y and @ kg/m ( @ ) , respectively .


Changes from baseline were significantly different between dairy product and SSP conditions for median homeostasis model assessment @-insulin sensitivity ( HOMA@ - % S ) ( @ vs. -@ % , respectively , P = @ ; baseline = @ % ) , mean LMTT disposition index ( -@ vs. -@ , respectively , P = @ ; baseline = @ ) , mean HDL cholesterol ( @ vs. -@ % , respectively , P = @ ; baseline = @ mg/dL ) , and mean serum @-hydroxyvitamin D -LSB- @ ( OH ) D -RSB- ( @ vs. -@ , respectively , P = @ ; baseline = @ g/L ) .


Changes from baseline in LMTT Matsuda insulin sensitivity index ( -@ vs. -@ , respectively ; baseline = @ ) and mean HOMA@ -- cell function ( -@ vs. @ % , respectively ; baseline = @ % ) did not differ significantly between treatments .


These results suggest that SSP consumption is associated with less favorable values for HOMA@ - % S , LMTT disposition index , HDL cholesterol , and serum @ ( OH ) D in men and women at risk of T@DM vs. baseline values and values during dairy product consumption .


This trial was registered at clinicaltrials.gov as NCT@ .


Neurofibromatosis type @ ( NF@ ) is an autosomal dominant disorder with an estimated prevalence of about @/@ , independent of ethnicity , race , or gender .


Attention Deficit Hyperactivity like Disorder ( ADHD ) - like characteristics are often reported in patients with NF@ .


We hypothesised that learning disabilities in NF@ children were related to ADHD symptoms .


Treatment with methylphenidate ( MPD ) has improved learning disabilities in ADHD by acting on neurotransmitters .


Our objective was to evaluate its efficacy on ADHD-like symptoms in neurofibromatosis type @ children ( @-@ years ) .


This was a randomised , double blind , placebo controlled , and crossover trial comparing @ to @ mg/kg/d of MPD as it is indicated for ADHD to placebo in NF@ children with ADHD-like symptoms .


Children aged @ to @years were eligible when their IQ was between @ and @ .


The total follow-up was @weeks including @weeks for each period and @week wash out .


Fifty subjects ( @ for each period ) were required for testing the primary study hypothesis .


The main outcome was an improvement in scores on the simplified Conners ' Parent Rating Scale .


Thirty-nine patients were included between April @ and December @ .


Twenty participants received MPD and @ placebo during the first period .


They all completed the trial .


MPD decreased the simplified Conners by @ points ( @ , p = @ ) .


This is the first randomised controlled trial showing the short-term benefit of MPD on simplified Conners scores in NF@ children .


Liver transection is considered a critical factor influencing intra-operative blood loss .


A increase in the number of complex liver resections has determined a growing interest in new devices able to ` optimize ' the liver transection .


The aim of this randomized controlled study was to compare a radiofrequency vessel-sealing system with the ` gold-standard ' clamp-crushing technique .


From January to December @ , @ consecutive patients undergoing a liver resection were randomized to the radiofrequency vessel-sealing system ( LF@ group ; N = @ ) or to the clamp-crushing technique ( Kelly group , N = @ ) .


Background characteristics of the two groups were similar .


There were not significant differences between the two groups in terms of blood loss , transection time and transection speed .


In spite of a not-significant larger transection area in the LF@ group compared with the Kelly group ( @ versus @cm ( @ ) , P = @ ) , the overall and ` per cm ( @ ) ' blood losses were similar whereas the transection speed was better ( even if not significantly ) in the LF@ group compared with the Kelly group ( @ cm ( @ ) / min versus @ , P = @ ) .


Mortality , morbidity and bile leak rates were similar in both groups .


The radiofrequency vessel-sealing system allows a quick and safe liver transection similar to the gold-standard clamp-crushing technique .


Enamel demineralization and gingival inflammation are the most prevalent consequences of biofilm formation in orthodontics .


Our hypothesis was that educating patients about the severe consequences of biofilm accumulation could enhance their oral hygiene while wearing fixed appliances .


This study was designed as a randomized controlled @-arm parallel trial .


A total of @ participants in Chengdu , China , matching the eligibility criteria of @ to @ years of age , at least @ natural teeth , and a treatment plan that included conventional stainless steel brackets , were randomly assigned to @ intervention groups based on computer-generated random sequencing using simple randomization without blocking .


In group A ( n = @ ) , the subjects were shown images illustrating the severe consequences of biofilm formation , including enamel demineralization and gingival inflammation ; subjects in group B ( n = @ ) were given biofilm disclosing tablets ; those in group C ( n = @ ) received a combination of A and B ; the subjects in group D ( n = @ ) served as the controls .


The investigators were blinded to the allocations , and the researcher managing the random sequence did not participate in allocation or measurement .


All groups received routine oral hygiene instructions .


Plaque index and gingival index scores were recorded at each appointment during a @-month follow-up .


Eighteen participants were lost during follow-up , resulting in a total of @ participants after the trial ( group A , @ ; group B , @ ; group C , @ ; group D , @ ) .


No adverse events were recorded .


Groups A and C exhibited a significantly lower plaque index scores ( parameter-estimate -LSB- @ % confidence interval -RSB- = -@ -LSB- -@ to -@ -RSB- for group A , and -@ -LSB- -@ to -@ -RSB- for group C ) and gingival index scores ( -@ -LSB- -@ to -@ -RSB- , and -@ -LSB- -@ to -@ -RSB- ) , respectively , compared with group D ( P < @ for all ) , whereas no significant difference was found between groups B and D , or between groups A and C ( P > @ ) .


The adults had significantly lower plaque index ( @ -LSB- @-@ @ -RSB- , P < @ ) and gingival index ( @ -LSB- @-@ @ -RSB- , P = @ ) scores than did the teenagers , and the female subjects had significantly higher gingival index ( -@ -LSB- -@ to -@ -RSB- , P = @ ) scores than did the male subjects .


The use of images showing the severe consequences of biofilm accumulation enhanced the oral hygiene of patients treated with fixed appliances .


The purpose of the study is to compare neuromuscular electrical stimulation ( NMES ) vs sham on leg strength at hospital discharge in mechanically ventilated patients .


We conducted a randomized pilot study of NMES vs sham applied to @ bilateral lower extremity muscle groups for @ minutes daily in the intensive care unit ( ICU ) .


Between June @ and March @ , we enrolled adults who were receiving mechanical ventilation within the first week of ICU stay and who could transfer independently from bed to chair before hospital admission .


The primary outcome was lower extremity muscle strength at hospital discharge using Medical Research Council score ( maximum , @ ) .


Secondary outcomes at hospital discharge included walking distance and change in lower extremity strength from ICU awakening .


Clinicaltrials.gov : NCT@ .


We stopped enrollment early after @ patients due to slow patient accrual and the end of research funding .


For NMES vs sham , mean ( SD ) lower extremity strength was @ ( @ ) vs @ ( @ ) , P = @ .


Among secondary outcomes , NMES vs sham patients had a greater mean ( SD ) walking distance ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- ft , P = @ ) and increase in muscle strength ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- , P = @ ) .


In this pilot randomized trial , NMES did not significantly improve leg strength at hospital discharge .


Significant improvements in secondary outcomes require investigation in future research .


To prospectively evaluate the efficacy of a traditional Chinese medicine ( TCM ) - based therapy for treating liver fibrosis in patients with chronic hepatitis B ( CHB ) , and to investigate the patients ' perception of the treatment 's effects on quality of life ( QoL ) .


A total of @ patients with CHB-related liver fibrosis were randomly assigned to treatment groups for receipt of a @-month course of the antiviral drug entecavir alone ( control group ) or in combination with the TCM Liuweiwuling tablets .


Patients were assessed before ( pre-treatment ) and after therapy and the treatment-related differences in clinical manifestations , levels of liver function markers and liver fibrosis indexes , color ultrasound images , and hepatitis B virus ( HBV ) DNA load were compared between the two groups by statistical analysis .


The generic QoL scale developed by the World Health Organization ( WHOQOL-BREF ) was used to score the patients ' perceptions of treatment outcome .


After treatment , the patients in both groups showed significant improvement in the majority of clinical manifestations ( both P less than @ ) , with the exception of bloating .


In addition , both groups showed significant improvements of liver function markers and in signs of liver fibrosis ( both P less than @ ) .


Both groups also showed significant reductions in the diameters of the portal and splenic ( both P less than @ ) , as well as increases in the rate of undetectable HBV DNA ( with a statistically similar outcome achieved in the two groups ) .


Finally , both groups had higher QoL scores after treatment , with all assessed parameters except environment showing a significant improvement ( all P less than @ ) .


When used in combination with entecavir , the TCM Liuweiwuling tablet is a safe therapy for CHB and its related liver fibrosis and may help to improve the QoL of these patients .


Progressive decline of psychophysical cone-mediated measures has been reported in type @ ( USH@ ) and type @ ( USH@ ) Usher syndrome .


Conventional cone electroretinogram ( ERG ) responses in USH demonstrate poor signal-to-noise ratio .


We evaluated cone signals in USH@ and USH@ by recording microvolt level cycle-by-cycle ( CxC ) ERG .


Responses of molecularly genotyped USH@ ( n = @ ) and USH@ ( n = @ ) subjects ( age range , @-@ years ) were compared with those of controls ( n = @ ) .


A subset of USH@ ( n = @ ) and USH@ ( n = @ ) subjects was examined two to four times over @ to @ years .


Photopic CxC ERG and conventional @-Hz flicker ERG were recorded on the same visits .


Usher syndrome subjects showed considerable cone flicker ERG amplitude losses and timing phase delays ( P < @ ) compared with controls .


USH@ and USH@ had similar rates of progressive logarithmic ERG amplitude decline with disease duration ( -@ log V/y ) .


Of interest , ERG phase delays did not progress over time .


Two USH@C subjects retained normal response timing despite reduced amplitudes .


The CxC ERG method provided reliable responses in all subjects , whereas conventional ERG was undetectable in @ of @ subjects .


Cycle-by-cycle ERG showed progressive loss of amplitude in both USH@ and USH@ subjects , comparable to that reported with psychophysical measures .


Usher subjects showed abnormal ERG response latency , but this changed less than amplitude with time .


In USH syndrome , CxC ERG is more sensitive than conventional ERG and warrants consideration as an outcome measure in USH treatment trials .


This study aimed to evaluate influence of ethnic factors on the pharmacokinetics of orally inhaled QMF@ , a novel combination of an approved longacting @-agonist , indacaterol ( Onbrez Breezhaler for COPD ) , and an approved inhaled corticosteroid , mometasone furoate ( MF ) , ( Asmanex Twisthaler for asthma ) , following multiple dose administration of QMF@ ( indacaterol acetate/MF ) @/@ g and @/@ g via the Breezhaler device in healthy Japanese and Caucasian subjects .


This was a single-center , openlabel , multiple-dose , two-period , complete crossover study that randomized healthy Japanese and , age and weight matched Caucasian subjects to QMF@ @/@ g or @/@ g once daily ( o.d. ) for @ days in each period .


Pharmacokinetics ( PK ) were assessed up to @ hours on days @ and @ .


@ Japanese and @ Caucasian healthy subjects were enrolled .


Indacaterol and MF had similar PK profiles across both the doses and both ethnic groups .


The maximum geometric mean ratios ( @ % confidence interval ( CI ) ) for Japanese vs. Caucasian subjects for Cmax were @ ( @ - @ ) and @ ( @ - @ ) for indacaterol and MF , respectively .


For AUC , the maximum ratios were @ ( @ - @ ) and @ ( @ - @ ) for indacaterol and MF , respectively .


The mild trend towards higher exposure in Japanese subjects could be explained by the fact that the mean body weight was @ % higher for Caucasians compared to their Japanese counterparts .


No serious adverse events or discontinuations related to study medication were reported .


The study demonstrated increase of mean exposure parameters in Japanese subjects vs. Caucasian subjects , which ranged between @ - @ % and @ - @ % , for indacaterol and MF components , respectively .


Multiple doses of both the QMF@ dose levels were safe and well-tolerated in all subjects .


Body weight was considered a key contributory factor for the observed difference in exposure .


These results suggest no dose adjustment for QMF@ is required in Asian populations .


The purpose of this study is to measure the prevalence of graded disc degeneration , spondylolisthesis , transitional segmentation , and the distribution of sacral slope in patients @ to @ years of age with chronic low back pain ( CLBP ) .


This retrospective study analyzed @ digital lumbar radiographic series obtained during a randomized controlled trial of chiropractic patients with CLBP .


Chronic low back pain was defined as pain in the low back lasting @ weeks or longer .


Radiographic findings of disc degeneration , spondylolisthesis , and lumbosacral transitional segmentation were graded by @ authors using established classification criteria .


Sacral slope was measured with a digital tool contained within imaging software .


Lumbosacral transitional segments graded I to IV ( Castellvi classification ) were present in @ % of cases .


Lumbar disc degeneration was most prevalent at L@-@ ( @ % ) , followed by L@-@ ( @ % ) , L@-@ ( @ % ) , L@-S@ ( @ % ) , and L@-@ ( @ % ) .


Isthmic spondylolisthesis was present in @ % of cases , with L@ the most common location .


Degenerative spondylolisthesis demonstrated a prevalence of @ % , most commonly occurring at L@ .


The prevalence of degenerative spondylolisthesis was @ % for women aged @ to @ years and @ % for men in the same age range .


Moderate-severe disc degeneration , multilevel disc narrowing , and degenerative spondylolisthesis were common in individuals with CLBP with age more than @ years .


Isthmic spondylolisthesis was not more prevalent than what has been reported in other populations .


Transitional segmentation was identified in a minority of participants , with some of these exhibiting accessory joints or fusion .


Mean sacral slope in individuals with CLBP was not substantially different from mean slopes reported in other populations .


( @ ) Compare ideal cut-off points for DS and % FEV@ at @ and @hto predict hospitalization/relapse in subjects with moderate to severe asthma exacerbation ( @ ) Develop a multivariate regression model using DS , % FEV@ , demographic , and clinical variables to predict hospitalization/relapse .


Subjects with acute exacerbation of asthma ( FEV@ < @ % predicted following @minof standardized treatment : @mg nebulized albuterol ; @-@ @ mg nebulized ipratropium ; and @mg oral prednisone ) were eligible .


All subjects had % FEV@ and DS obtained at baseline and hourly for @h .


Using hospitalization/relapse as the outcome of interest ; we compared the area under the receiveroperator curves ( AUC ) between the @ and @hDS and % FEV@ measurements , and the AUC for the change in DS and % FEV@ between baseline and hour-@ .


We determined ideal cut-points for % FEV@ and DS to maximize sensitivity and specificity .


Sensitivity , specificity , positive and negative predictive values , and positive and negative likelihood ratios ( LR ) were compared between % FEV@ and DS .


We developed a multivariate regression model examining the association of specific demographic and clinical variables to hospitalization/relapse .


@ patients were included for analysis .


The AUC was greatest for the @-hDS ( @ ) , followed by the @-h % FEV@ ( @ ) .


Optimum cut-off values were a DS of @ , and an FEV@ of @ % .


These were associated with a + LR for the composite outcome of @ and @ respectively .


Logistic regression showed baseline DS , @-hDS , change in DS , and oxygen use at hour @ were all associated with the composite outcome .


The @-hscore for % FEV@ and DS performed better than scores at any other time point and better than either parameter over time .


The @-hDS had the greatest association with the composite outcome .


Neither test was a strong enough predictor to be used solely for this purpose .


Sarcopenia is currently best described as an age-related decline in skeletal muscle mass and function .


However , no consensus exists as to how to best quantify muscle function in older adults .


The muscle quality index ( MQI ) was recently recommended as an ideal evidence-based assessment of functional status in older adults .


Nevertheless , the usefulness of MQI to assess physical function is limited by whether it is reflective of muscle qualitative changes to an intervention .


Thus , the purpose of this investigation was to determine whether MQI changes in response to resistance exercise training and detraining and how such changes correspond to other recommended measures of physical function proposed by suggested definitions of sarcopenia .


Twenty-five older adults ( @ y ; BMI = @ kgm ( -@ ) ) completed a @-week resistance training program in a wait-list controlled , cross-over design .


MQI was determined as power output from timed sit to stand ( STS ) , body mass , and leg length .


Gait speed , hand grip strength , get-up-and-go and lean body mass ( LBM ) were evaluated before and after exercise training and detraining .


MQI and functional changes to training and detraining were evaluated with repeated measures ANOVA and clinical interpretations of magnitude based inferences .


Short term resistance training significantly and clinically improved MQI ( @ to @ W ) , gait time ( @ to @ s ) and sit to stand performance ( @ to @ s ) .


Changes in LBM and hand grip strength were not significant or clinically meaningful .


De-training for @-weeks did not result in significant changes in any measure from post-training performance .


The decreased number and senescence of circulating endothelial progenitor cells ( EPCs ) are considered markers of vascular senescence associated with aging , atherosclerosis , and coronary artery disease ( CAD ) in elderly .


In this study , we explore the role of vascular senescence in premature CAD ( PCAD ) in a developing country by comparing the numerical status and senescence of circulating EPCs in PCAD patients to controls .


EPCs were measured by flow cytometry in @ patients with angiographically documented CAD , and @ controls without evidence of CAD , recruited from random patients @ years of age at All India Institute of Medical Sciences .


EPC senescence as determined by telomere length ( EPC-TL ) and telomerase activity ( EPC-TA ) was studied by real time polymerase chain reaction ( q PCR ) and PCR - ELISA respectively .


The number of EPCs ( @ % Vs. @ % of total WBCs , p < @ ) , and EPC-TL ( @ Vs. @ kb/genome , p = @ ) were markedly lower in PCAD patients compared to controls .


These differences persisted after adjustment for age , sex , BMI , smoking and medications .


EPC-TA was reduced in PCAD patients , but was statistically significant only after adjustment for confounding factors ( @ Vs. @ IU/cell , unadjusted p = @ , adjusted p = @ ) .


We observed an association between increased vascular cell senescence with PCAD in a sample of young patients from India .


This suggests that early accelerated vascular cell senescence may play an important mechanistic role in CAD epidemic in developing countries like India where PCAD burden is markedly higher compared to developed countries .


To compare the clinical efficacy differences between medicinal vesiculation combined with quick cupping at Shenque ( CV @ ) and regular medication for allergic rhinitis with syndrome of yang deficiency .


Eighty-two cases were randomly divided into an observation group ( @ cases ) and a control group ( @ cases ) .


The observation group was treated with medicinal vesiculation combined with quick cupping at Shenque ( CV @ ) .


The medicinal vesiculation was applied at Feishu ( BL @ ) , Gaohuang ( BL @ ) , Fengmen ( BL @ ) , Mingmen ( GV @ ) on the dog days in the summer , one treatment on the @st dog-day , @nd dog-day and last dog-day respectively with an interval of @ days between two treatments .


Three treatments were taken as one course , and totally one course was given .


The quick cupping was applied at Shenque ( CV @ ) , once a day , ten treatments were taken as one course , and totally three courses was given .


The control group was treated with oral administration of loratadine and nasal spray of budesonide .


The loratadine was given @ mg per time , once a day for continuous @ days ; budesonide was given once a day , ten treatments were taken as one course , and totally three courses was given .


The clinical efficacy in two groups after treatment was observed , and the contents of immune globulin E ( IgE ) , interleukin-@ ( IL-@ ) , interleukin-@ ( IL-@ ) and tumor necrosis factor - ( TNF - ) in peripheral serum were measured before and after the treatments .


Of all the @ patients , @ cases completed the treatment , and @ patient in the observation group and @ patients in the control group dropped out .


The effective rate was @ % ( @/@ ) in the observation group , which was superior to @ % ( @/@ ) in the control group ( P < @ ) .


After treatment , both groups effectively reduced the contents of IgE , IL-@ , IL-@ and TNF - , and the observation group had superior effect on reducing IgE and IL-@ to the control group ( P < @ ) .


The medicinal vesiculation combined with quick cupping at Shenque ( CV @ ) have better effect for allergic rhinitis with syndrome of yang deficiency than oral administration of loratadine and nasal spray of budesonide .


Tamsulosin and mirabegron may be used concomitantly in patients with lower urinary tract symptoms .


Since alpha@-adrenoceptor antagonists are associated with cardiovascular side effects , potential pharmacokinetic and cardiovascular interactions were evaluated .


This was an open-label , randomized , @-arm , @-sequence study in @ healthy men ( @/arm ) aged @ - @ years .


In arm @ , subjects received single-dose tamsulosin hydrochloride modified release capsules ( @ mg ) alone and with steady-state mirabegron oral controlled absorption system tablets ( @ mg once daily ) in random sequence .


In arm @ , subjects received single-dose mirabegron alone and with steady-state tamsulosin .


Samples for mirabegron and tamsulosin plasma concentrations were collected .


Blood pressure ( BP ) and pulse rate ( PR ) were measured and orthostatic stress tests were performed .


Mirabegron increased tamsulosin C ( max ) to @ % ( @ % confidence interval ( CI ) @ - @ % ) , AUC ( ) to @ % ( @ % CI @ - @ % ) , and t ( @/@ ) to @ % .


Tamsulosin reduced mirabegron C ( max ) to @ % ( @ % CI @ - @ % ) and AUC ( ) to @ % ( @ % CI @ - @ % ) without effect on t@/@ .


Mirabegron and tamsulosin co-treatment caused no statistically significant changes ( p > @ ) in PR or systolic BP versus mono-treatment up to @ hours post-dose .


Mean diastolic BP decreases of -@ ( @ % CI -@ , -@ ) to -@ ( -@ , -@ ) mmHg in arm @ and -@ ( -@ , -@ ) to -@ ( -@ , -@ ) mmHg in arm @ were observed , statistically significant ( p < @ ) at several time points , not accompanied by orthostatic symptoms or increases in positive orthostatic stress tests .


Adverse and orthostatic events were balanced across treatments .


The observed pharmacokinetic interactions upon add-on of mirabegron or tamsulosin to existing tamsulosin or mirabegron therapy did not cause clinically relevant changes in cardiovascular safety or safety profiles .


The efficacy of single-allergen-specific immunotherapy in polysensitized subjects is a matter of debate .


This study aimed to investigate the efficacy of house dust mite ( HDM ) sublingual immunotherapy ( SLIT ) in monosensitized and polysensitized children .


A total of @ children , aged @ to @ years old , with HDM-induced respiratory allergic diseases were allocated to a monosensitized group ( n = @ ) or a polysensitized group ( n = @ ) .


Both groups were treated by standard pharmacotherapy and SLIT with Dermatophagoides farinae ( American HDM ) extracts for @ weeks .


Symptoms , medications , visual analogue scale ( VAS ) , and presence of adverse events ( AEs ) were assessed once a month .


Skin-prick test ( SPT ) was done before and after treatment .


After treatment , subjects in the polysensitized group who completed the study were further analyzed as subgroup @ ( n = @ ) and subgroup @ ( n = @ ) according to the number of coexisting allergens .


Forty-one subjects in the monosensitized group and @ subjects in the polysensitized group completed the study .


The global clinical parameters had significantly improved after treatment , with no significant difference between the monosensitized and polysensitized group throughout this period ( all p > @ ) .


The comparison among the monosensitized group , subgroup @ , and subgroup @ indicated that there was no significant difference in symptoms scores and VAS at each scheduled follow-up visit .


There was also no significant difference in total medications score ( TMS ) in the monosensitized group , subgroup @ , and subgroup @ after week @ ( all p > @ ) .


No severe systemic AEs were reported .


No significant difference was observed in the clinical effects of HDM SLIT between polysensitized and monosensitized children with respiratory allergic diseases .


Obesity is associated with cardiometabolic disease , including insulin resistance ( IR ) and diabetes .


Cyclic guanosine monophosphate ( cGMP ) signaling affects energy balance , IR , and glucose metabolism in experimental models .


We sought to examine effects of phosphodiesterase-@ inhibition with tadalafil on IR in a pilot study of obese nondiabetic individuals .


We conducted a randomized , double-blinded , placebo-controlled trial of adults age @ to @ years with obesity and elevated fasting insulin levels ( @ U/mL ) .


Participants were randomized to tadalafil @ mg daily or placebo for @ months .


Oral glucose tolerance tests were performed , and the effect of tadalafil on IR was examined .


A total of @ participants ( mean age , @ years ; body mass index -LSB- BMI -RSB- , @ kg/m ( @ ) ) were analyzed , @ randomized to tadalafil and @ to placebo .


In the overall sample , measures of IR did not differ between tadalafil and placebo groups at @ months .


However , in individuals with severe obesity ( BMI @ kg/m ( @ ) ) , tadalafil use was associated with improved IR ( homeostatic model assessment for IR ) , compared to placebo ( P = @ , respectively ) .


Furthermore , one measure of - cell compensation for IR ( oral disposition index ) improved with tadalafil in the overall sample ( P = @ ) and in the subgroup with severe obesity ( P = @ ) .


Results of this pilot study did not show improvements in IR with tadalafil , compared to placebo .


However , tadalafil may have favorable effects on - cell compensation , particularly in individuals with severe obesity .


Future studies evaluating the potential metabolic benefits of cGMP modulation in obesity are warranted .


Inpatient medical settings offer an opportunistic environment for initiating smoking cessation interventions to patients reflecting on their health .


Current evidence has shown the superior efficacy of varenicline tartrate ( VT ) for smoking cessation compared with other tobacco cessation therapies ; however , recent evidence also has highlighted concerns about the safety and tolerability of VT. .


Given these apprehensions , we aimed to evaluate the safety and effectiveness of VT plus quitline-counseling compared to quitline-counseling alone in the inpatient medical setting .


Adult patients ( n = @ , @-@ years ) admitted with a smoking-related illnesses to @ hospitals were randomized to receive either @ weeks of varenicline tartrate ( titrated from @ mg daily to @mg twice daily ) plus quitline-counseling ( VT+C ) , ( n = @ ) or quitline-counseling alone ( n = @ ) .


VT was well tolerated in the inpatient setting among subjects admitted with acute smoking-related illnesses ( mean age @ and @ years in the VT+C and counseling alone groups , respectively ) .


The most common self-reported adverse event during the @-week treatment phase was nausea ( @ % in the VT+C group compared with @ % in the counseling alone group ) .


Thirteen deaths occurred during the study period ( n = @ were in the VT+C arm compared with n = @ in the counseling alone arm ) .


All of these subjects had known comorbidities or developed underlying comorbidities .


VT appears to be a safe and well-tolerated opportunistic treatment for inpatient smokers who have related chronic disease .


Based on the proven efficacy of varenicline from outpatient studies and our recent inpatient evidence , we suggest it be considered as part of standard care in the hospital setting .


Although the VITA @D-Master ( @D ) shade guide offers improved shade-matching performance , many dental materials are only available in VITA Classical ( VC ) shades .


This study aimed to clarify whether it is possible to convert @D shades determined by observers into VC shades ( indirect method ) without adding a clinically significant error in comparison with direct shade determination using the VC shade guide .


Forty ceramic specimens were fabricated .


L * a * b * values were recorded using a spectroradiometer .


Sixty participants ( @ dentists , @ technicians , and @ students ) were recruited and asked to determine the shades of specimens using the VC and @D shade guides under standardized conditions .


Conversion tables were constructed by allocating the closest VC shade tab to every matched @D shade and by use of an optimization algorithm ( indirect methods ) .


Differences between E values for VC matches and for the indirect methods were evaluated using t tests .


A mean E ( SD ) of @ ( @ ) for VC and @ ( @ ) for @D was observed ( P = @ ) .


Compared with direct shade matching using VC , the indirect method with the optimized tables resulted in a mean E of @ ( @ ) , which was not significantly different ( P = @ ) .


Within the limitations of this study , the conversion tables were suitable for the determination of tooth color using the @D shade guide followed by conversion into VC shades without adding a clinically significant error .


It has been well documented that the maturing oocyte is very vulnerable to changes in its micro-environment , the follicular fluid ( FF ) .


Recent research has focused on different components within this FF , like hormones , growth factors and metabolites , and how their concentrations are altered by diet and the metabolic health of the mother .


It has been proposed that fatty acids ( FAs ) are potential factors that influence oocyte maturation and subsequent embryo development .


However , a thorough study of the specific FF FA composition per lipid fraction and how this may be affected by BMI is currently lacking .


Therefore , we investigated the BMI-related concentration of FAs in the phospholipid ( PL ) , cholesteryl-ester ( CHE ) , triglyceride ( TG ) and non-esterified ( NE ) lipid fraction in the FF of women undergoing assisted reproductive treatment ( ART ) .


In this descriptive cross-sectional study , the FF of normal weight ( @ BMI < @ kg/m ( @ ) , n = @ ) , overweight ( @ BMI < @ kg/m ( @ ) , n = @ ) and obese ( BMI@ @ kg/m ( @ ) , n = @ ) women , undergoing ART , was sampled and analyzed for @ specific FAs in the PL , CHE , TG and NEFA fraction , using a gas chromatographic analysis method .


Differences between BMI-groups were studied by means of univariate general linear models and post hoc Sheff tests .


Total FA concentrations in the PL and CHE fraction did not differ between BMI groups .


Total TG concentrations tended to differ and total NEFA concentrations differed significantly between BMI groups .


Interestingly , @ % and @ % of the total FAs was esterified in the PL and CHE fraction , respectively , while only @ % were present in both the TG and NEFA fraction .


Only few individual FA concentrations differed in the PL , CHE and TG fraction between BMI groups , whereas abundant BMI-related differences were found in the NEFA fraction .


Our data show that differences in BMI are associated with alterations in the FA composition of the FF , an effect most pronounced in the NEFA fraction .


These BMI-related variations could possibly affect granulosa cell viability , oocyte developmental competence and subsequent embryo quality possibly explaining differences in oocyte quality in obese patients described by others .


To compare three children 's sodium fluoride toothpastes to placebo with respect to enamel remineralisation potential , enamel fluoride uptake and net acid resistance using an in situ palatal caries model in children aged @-@ years following a single brushing .


This was a randomised , single blind ( laboratory analyst ) , single-centre , four-treatment , crossover study with a @-day washout period between treatments .


The treatments were @,@ ppm fluoride , @,@ ppm fluoride , @ ppm fluoride and @ ppm fluoride ( placebo ) toothpaste ( NaF/silica ) .


A custom made in situ palatal appliance was used by each subject in all treatment periods .


At each of the four treatment visits subjects wore the appliance containing four partially demineralised human enamel specimens for @ minutes and then brushed their teeth using a standardised procedure for @ seconds under supervision using @ g ( @ g ) of their assigned toothpaste .


After @ hours the appliance was removed and enamel specimen recovered .


This process was repeated until all subjects completed all four study treatment visits .


Recovered enamel specimens were analysed for per cent surface microhardness recovery ( % SMHR ; Knoop ) and enamel fluoride uptake ( EFU ; microdrill biopsy ) .


Subsequently , specimens were demineralised in vitro to determine their % net acid resistance ( % NAR ; Knoop ) .


All three fluoride toothpastes demonstrated significantly greater % SMHR , EFU and % NAR compared with @ ppm F toothpaste .


The model demonstrated a dose response over the range @ to @,@ ppm fluoride for % SMHR , EFU and % NAR .


There was no significant difference between @ ppm F and @,@ ppm F for % SMHR and between @,@ ppm F and @,@ ppm F for % SMHR , EFU and % NAR .


The present in situ study demonstrated that the children 's fluoride toothpastes tested are capable of delivering cariostatic amounts of fluoride to early caries lesions following a single brushing .


This randomised phase II trial compared dose-escalated weekly paclitaxel ( wPTX ) vs standard-dose wPTX for patients with previously treated advanced gastric cancer ( AGC ) .


Ninety patients were randomised to a standard dose of wPTX ( @mgm ( -@ ) ) or an escalated dose of wPTX ( @-@mgm ( -@ ) ) to assess the superiority of overall survival ( OS ) with a one-sided alpha error of @ and a power of @ .


The median OS showed a trend towards longer survival in the dose-escalated arm ( @ vs @ months ; hazard ratio ( HR ) , @ ; one-sided P = @ ) , although it was statistically not significant .


The median progression-free survival ( PFS ) was significantly longer in the dose-escalated arm ( @ vs @ months , HR , @ ; P = @ ) .


Objective response rate was @ % with dose escalation and @ % with standard dose ( P = @ ) .


The frequency of all grades of neutropenia was significantly higher with dose escalation ( @ % vs @ % , P = @ ) ; however , no significant difference was observed in the proportion of patients experiencing grade @ or more ( @ % vs @ % , P = @ ) .


Dose-escalated wPTX in patients with pretreated AGC met our predefined threshold of primary end point , OS ( P < @ ) ; however , it did not show a significantly longer OS .


Progression-free survival was significantly better with dose escalation .


Abdominal obesity and exaggerated postprandial lipemia are independent risk factors for cardiovascular disease ( CVD ) and mortality , and both are affected by dietary behavior .


We investigated whether dietary supplementation with whey protein and medium-chain saturated fatty acids ( MC-SFAs ) improved postprandial lipid metabolism in humans with abdominal obesity .


We conducted a @-wk , randomized , double-blinded , diet intervention study .


Sixty-three adults were randomly allocated to one of @ diets in a @ @ factorial design .


Participants consumed @ g milk protein ( whey or casein ) and @ g milk fat ( with high or low MC-SFA content ) daily .


Before and after the intervention , a high-fat meal test was performed .


We measured changes from baseline in fasting and postprandial triacylglycerol , apolipoprotein B-@ ( apoB-@ ; reflecting chylomicrons of intestinal origin ) , free fatty acids ( FFAs ) , insulin , glucose , glucagon , glucagon-like peptide @ ( GLP-@ ) , and gastric inhibitory polypeptide ( GIP ) .


Furthermore , changes in the expression of adipose tissue genes involved in lipid metabolism were investigated .


Two-factor ANOVA was used to examine the difference between protein types and fatty acid compositions , as well as any interaction between the two .


Fifty-two participants completed the study .


We found that the postprandial apoB-@ response decreased significantly after whey compared with casein ( P = @ ) independently of fatty acid composition .


Furthermore , supplementation with casein resulted in a significant increase in the postprandial GLP-@ response compared with whey ( P = @ ) .


We found no difference in postprandial triacylglycerol , FFA , insulin , glucose , glucagon , or GIP related to protein type or MC-SFA content .


We observed no interaction between milk protein and milk fat on postprandial lipemia .


We found that a whey protein supplement decreased the postprandial chylomicron response compared with casein in persons with abdominal obesity , thereby indicating a beneficial impact on CVD risk .


This trial was registered at clinicaltrials.gov as NCT@ .


Aging involves a progressive reduction of respiratory muscle strength as well as muscle strength .


Compare the effects of resistance training volume on the maximum inspiratory pressure ( MIP ) , maximum expiratory pressure ( MEP ) , functional performance , and muscle strength in elderly women .


Thirty elderly women were randomly assigned to a group performing either single sets ( @-SET ) or three sets ( @-SET ) of exercises .


The sit-to-stand test , MIP , MEP , and muscle strength were assessed before and after @ training sessions .


Progressive resistance training was performed two times per week for a total of @-@ repetitions , using the main muscle groups of the upper and lower limbs .


The main results showed that the participants significantly increased their MEP ( P < @ ; @-SET : @ % ; @-SET : @ % ) and MIP ( P < @ ; @-SET : @ % ; @-SET : @ % ) .


Both groups also improved in the sit-to-stand test ( P < @ ; @-SET : @ % ; @-SET : @ % ) .


After @ training sessions , muscle strength also significantly increased ( P < @ ; @ % -@ % ) in both groups .


An intergroup comparison did not show any statistically significant differences between the groups in any of the parameters analyzed .


Single - and multiple-set resistance training programs increased MIP , MEP , muscle strength , and sit-to-stand test performance in elderly women after @ sessions of training .


In conclusion , our results suggested that elderly women who are not in the habit of physical activity may start with single-set resistance training programs as a short-term strategy for the maintenance of health .


Infliximab , a tumor necrosis factor antagonist , is effective for treating patients with Crohn 's disease ( CD ) and ulcerative colitis ( UC ) .


We aimed to determine whether dosing based on therapeutic drug monitoring increases rate of remission and whether continued concentration-based dosing is superior to clinically based dosing of infliximab for maintaining remission in patients with CD and UC .


We performed a @-year randomized controlled trial at a tertiary referral center , including @ adults ( @ with CD and @ with UC ) with stable responses to maintenance infliximab therapy .


Doses were escalated or reduced using an algorithm to reach a target trough concentration ( TC ) of @-@ g/mL in all patients ( optimization phase ) .


Patients were randomly assigned ( @:@ ) to groups that received infliximab dosing based on their clinical features ( n = @ ) or continued dosing based on TCs ( n = @ ) ( maintenance phase ) .


The primary end point was clinical and biochemical remission at @ year after the optimization phase .


At screening , @ of @ patients had a TC of infliximab of @-@ g/mL ( @ % ) .


Of @ patients with TCs < @ g/mL , @ patients ( @ % ) achieved TCs of @-@ g/mL after dose escalation .


This resulted in a higher proportion of CD patients in remission than before dose escalation ( @ % vs @ % ; P = @ ) and a decrease in the median concentration of C-reactive protein , compared with before the dose increase ( @ vs @ mg/L ; P < @ ) ; these changes were not observed in patients with UC .


Of @ patients with TCs > @ g/mL , @ patients ( @ % ) achieved TCs of @-@ g/mL after dose reduction .


This resulted in a @ % reduction in drug cost from before dose reduction ( P < @ ) .


Sixty-six percent of patients whose dosing was based on clinical features and @ % whose dosing was based on TC achieved remission , the primary end point ( P = @ ) .


Disease relapsed in @ patients who received clinically based dosing ( @ % ) and @ patients who received concentration-based dosing ( @ % ) ( P = @ ) .


Targeting patients ' infliximab TCs to @-@ g/mL results in a more efficient use of the drug .


After dose optimization , continued concentration-based dosing was not superior to clinically based dosing for achieving remission after @ year , but was associated with fewer flares during the course of treatment .


ClinicalTrialsRegister.eu number : @-@-@ .


To determine if volunteers can simulate and reproduce @ types of neurologic field defects : hemianopia , quadrantanopia , and central scotoma .


Cross-sectional study .


Thirty healthy volunteers new to perimetry ( including automated perimetry ) .


After informed consent , volunteers were randomized to @ of the @ visual field defects listed above .


All visual field testing was performed on the right eye using the Humphrey Field Analyzer ( HFA ; Carl Zeiss Meditec , Dublin , CA ) SITA Fast @-@ protocol .


Each volunteer was provided with standard new patient instructions and was shown a diagram of the defect to be simulated .


Two sets of visual fields were performed on the right eye with @ minutes between tests .


Three experts used the Ocular Hypertension Treatment Study reading center criteria and determined if the simulation was successful .


Proportion of volunteers able to simulate the assigned visual field .


All @ volunteers ( @ % ) successfully simulated a hemianopia on the first and second fields .


All @ volunteers ( @ % ) simulated a quadrantanopia on the first field and @ ( @ % ) did so on the second field .


Eight volunteers ( @ % ) successfully simulated a central scotoma in the first field and all @ ( @ % ) did so on in the second field .


Reliability criteria were excellent .


Forty-seven fields ( @ % ) had @ fixation losses , @ ( @ % ) had @ false-positive results , and @ ( @ % ) had @ false-negative results .


It is easy to simulate reproducible and reliable neurologic field defects on automated perimetry using HFA .


The authors investigated the efficacy of bilateral suprazygomatic maxillary nerve block ( SMB ) for postoperative pain relief in infants undergoing cleft palate repair .


In this prospective , double-blind , single-site , randomized , and parallel-arm controlled trial , @ children were assigned to undergo bilateral SMB with general anesthesia with either @ ml/kg of @ % ropivacaine ( Ropi group ) or @ ml/kg of isotonic saline ( Saline group ) on each side .


The primary endpoint was total postoperative morphine consumption at @ h. Pain scores and respiratory - and SMB-related complications were noted .


The overall dose of intravenous morphine after @ h ( mean -LSB- @ % CI -RSB- ) was lower in the Ropi group compared with that in the Saline group ( @ -LSB- @ to @ -RSB- vs. @ -LSB- @ to @ -RSB- g/kg ; P = @ ) .


Continuous morphine infusion was less frequent in the Ropi group compared with that in the Saline group ( @ patient -LSB- @ % -RSB- vs. @ patients -LSB- @ % -RSB- ; P = @ ) .


Three patients in the Saline group had an episode of oxygen desaturation requiring oxygen therapy .


There were no technical failures or immediate complications of the SMB .


Intraoperative hemodynamic parameters , doses of sufentanil , pain scores , and postoperative hydroxyzine requirements were not different between the two groups .


Bilateral SMB is an easy regional anesthesia technique that reduces total morphine consumption at @ h after cleft palate repair in children and the use of continuous infusion of morphine and may decrease postoperative respiratory complications .


To evaluate the efficacy and safety of AVP-@ , a drug-device combination of low-dose sumatriptan powder ( @mg loaded dose ) delivered intranasally through a targeted Breath Powered device vs an identical device containing lactose powder ( placebo device ) in the treatment of migraine headache .


Early treatment of migraine headaches is associated with improved outcome , but medication absorption after oral delivery may be delayed in migraineurs because of reduced gastric motility .


Sumatriptan powder administered with an innovative , closed-palate , Bi-Directional , Breath Powered intranasal delivery mechanism is efficiently absorbed across the nasal mucosa and produces fast absorption into the circulation .


Results from a previously conducted placebo-controlled study of AVP-@ showed a high degree of headache relief with an early onset of action ( eg , @ % AVP-@ vs @ % placebo device at @ hour , P < @ ) .


In this double-blind , placebo-controlled , parallel-group study in adults with a history of migraine with or without aura , participants were randomized via computer-generated lists to AVP-@ or placebo device to treat a single migraine headache of moderate or severe intensity .


The primary endpoint was headache relief ( defined as reduction of headache pain intensity from severe or moderate migraine headache to mild or none ) at @ hours post-dose .


Two hundred and thirty patients ( @ AVP-@ and @ placebo device ) were randomized , of whom @ ( @ and @ , respectively ) experienced a qualifying migraine headache ( their next migraine headache that reached moderate or severe intensity ) .


A significantly greater proportion of AVP-@ patients reported headache relief at @ hours post-dose compared with those using the placebo device ( @ % vs @ % , P = @ , odds ratio @ , @ % confidence interval -LSB- @ , @ -RSB- ) .


Between-group differences in headache relief were evident as early as @ minutes , reached statistical significance at @ minutes post-dose ( @ % vs @ % , P = @ ) , and were sustained at @ hours ( @ % vs @ % , P = @ ) and @ hours ( @ % vs @ % , P = @ ) .


Thirty-four percent of patients treated with AVP-@ were pain-free at @ hours compared with @ % using the placebo device ( P = @ ) .


More AVP-@ patients reported meaningful pain relief ( patient interpretation ) of migraine within @ hours of treatment vs placebo device ( @ % vs @ % , P < @ ) , and fewer required rescue medication ( @ % vs @ % , P = @ ) .


Total migraine freedom ( patients with no headache , nausea , phonophobia , photophobia , or vomiting ) reached significance following treatment with AVP-@ at @ hour ( @ % vs @ % ; P = @ ) .


There were no serious adverse events ( AEs ) , and no systemic AEs occurred in more than one patient .


Chest pain or pressure was not reported , and only one patient taking AVP-@ reported mild paresthesia .


No other triptan sensations were reported .


Targeted delivery of a low-dose of sumatriptan powder via a novel , closed-palate , Breath Powered , intranasal device ( AVP-@ ) provided fast relief of moderate or severe migraine headache in adults that reached statistical significance over placebo by @ minutes .


The treatment was well tolerated with a low incidence of systemic AEs .


To characterize the pharmacokinetics ( PK ) and pharmacodynamics ( PD ) of a new insulin glargine comprising @ units mL ( -@ ) ( Gla-@ ) , compared with insulin glargine @ units mL ( -@ ) ( Gla-@ ) at steady state in people with type @ diabetes .


A randomized , double-blind , crossover study ( N = @ ) was conducted , applying the euglycemic clamp technique over a period of @ h.


In this multiple-dose to steady-state study , participants received once-daily subcutaneous administrations of either @ ( cohort @ ) or @ units kg ( -@ ) ( cohort @ ) Gla-@ for @ days in one treatment period and @ units kg ( -@ ) Gla-@ for @ days in the other .


Here we focus on the results of a direct comparison between @ units kg ( -@ ) of each treatment .


PK and PD assessments performed on the last treatment day included serum insulin measurements using a radioimmunoassay and the automated euglycemic glucose clamp technique over @ h.


At steady state , insulin concentration ( INS ) and glucose infusion rate ( GIR ) profiles of Gla-@ were more constant and more evenly distributed over @ h compared with those of Gla-@ and lasted longer , as supported by the later time ( @ h ) to @ % of the area under the serum INS and GIR time curves from time zero to @ h post dosing .


Tight blood glucose control ( @ mg dL ( -@ ) ) was maintained for approximately @ h longer ( median of @ h ) with Gla-@ compared with Gla-@ .


Gla-@ provides more even steady-state PK and PD profiles and a longer duration of action than Gla-@ , extending blood glucose control well beyond @ h.


To evaluate intramuscular ketorolac compared with placebo saline injection for pain control with intrauterine device ( IUD ) placement .


We conducted a randomized , double-blind , placebo-controlled trial between July @ and March @ .


Patients received @ mg ketorolac or placebo saline intramuscular injection @ minutes before IUD placement .


The primary outcome was pain with IUD placement on a @-cm visual analog scale .


Sample size was calculated to provide @ % power to show a @-cm difference ( = @ ) in the primary outcome .


Secondary outcomes included pain with study drug injection , speculum insertion , tenaculum placement , uterine sounding , and at @ and @ minutes after IUD placement .


A total of @ women participated in the study , @ in the ketorolac arm and @ in the placebo arm .


There were no differences in baseline demographics including age , body mass index , and race .


There were no differences in median pain scores for IUD placement in the placebo compared with ketorolac groups ( @ compared with @ cm , P = @ ) .


There was a decrease in median pain scores at @ minutes ( @ compared with @ cm , P. @ ) and @ minutes ( @ compared with @ cm , P. @ ) after IUD placement but no difference for all other time points .


Nulliparous participants ( n = @ , eight per arm ) had a decrease in pain scores with IUD placement ( @ compared with @ cm , P = @ ) .


In this study , @ % of participants in the placebo group and @ % in the ketorolac group reported injection pain was as painful as IUD placement .


Ketorolac does not reduce pain with IUD placement but does reduce pain at @ and @ minutes after placement .


To study activin signaling and its blockade in sporadic inclusion body myositis ( sIBM ) through translational studies and a randomized controlled trial .


We measured transforming growth factor signaling by SMAD@/@ phosphorylation in muscle biopsies of @ patients with neuromuscular disease ( @ with sIBM ) .


We tested inhibition of activin receptors IIA and IIB ( ActRII ) in @ patients with sIBM using one dose of bimagrumab ( n = @ ) or placebo ( n = @ ) .


The primary outcome was the change in right thigh muscle volume by MRI at @ weeks .


Lean body mass , strength , and function were secondary outcomes .


Twelve of the patients ( @ bimagrumab , @ placebo ) participated in a subsequent @-week observation phase .


Muscle SMAD@/@ phosphorylation was higher in sIBM than in other muscle diseases studied ( p = @ ) .


Eight weeks after dosing , the bimagrumab-treated patients increased thigh muscle volume ( right leg +@ % compared with placebo , p = @ ; left leg +@ % , p = @ ) and lean body mass ( +@ % compared with placebo , p = @ ) .


Subsequently , bimagrumab-treated patients had improved @-minute walking distance , which peaked at @ weeks ( +@ % , p = @ ) compared with placebo .


There were no serious adverse events ; the main adverse events with bimagrumab were mild acne and transient involuntary muscle contractions .


Transforming growth factor superfamily signaling , at least through ActRII , is implicated in the pathophysiology of sIBM .


Inhibition of ActRII increased muscle mass and function in this pilot trial , offering a potential novel treatment of sIBM .


This study provides Class I evidence that for patients with inclusion body myositis , bimagrumab increases thigh muscle volume at @ weeks .


Although dental care settings provide an exceptional opportunity to reach smokers and provide brief cessation advice and treatment to reduce oral and other tobacco-related health conditions , dental care providers demonstrate limited adherence to evidence-based guidelines for treatment of tobacco use and dependence .


Guided by a multi-level , conceptual framework that emphasizes changes in provider beliefs and organizational characteristics as drivers of improvement in tobacco treatment delivery , the current protocol will use a cluster , randomized design and multiple data sources ( patient exit interviews , provider surveys , site observations , chart audits , and semi-structured provider interviews ) to study the process of implementing clinical practice guidelines for treating tobacco dependence in @ public dental care clinics in New York City .


The specific aims of this comparative-effectiveness research trial are to : compare the effectiveness of three promising strategies for implementation of tobacco use treatment guidelines-staff training and current best practices ( CBP ) , CBP + provider performance feedback ( PF ) , and CBP+PF + provider reimbursement for delivery of tobacco cessation treatment ( pay-for-performance , or P@P ) ; examine potential theory-driven mechanisms hypothesized to explain the comparative effectiveness of three strategies for implementation ; and identify baseline organizational factors that influence the implementation of evidence-based tobacco use treatment practices in dental clinics .


The primary outcome is change in providers ' tobacco treatment practices and the secondary outcomes are cost per quit , use of tobacco cessation treatments , quit attempts , and smoking abstinence .


We hypothesize that the value of these promising implementation strategies is additive and that incorporating all three strategies ( CBP , PF , and P@P ) will be superior to CBP alone and CBP+PF in improving delivery of cessation assistance to smokers .


The findings will improve knowledge pertinent to the implementation , dissemination , and sustained utilization of evidence-based tobacco use treatment in dental practices .


Multicenter , randomized , controlled trial on preoperative pain neuroscience education ( NE ) for lumbar radiculopathy .


To determine if the addition of NE to usual preoperative education would result in superior outcomes with regard to pain , function , surgical experience , and health care utilization postsurgery .


One in @ patients after lumbar surgery ( LS ) for radiculopathy experience persistent pain and disability , which is nonresponsive to perioperative treatments .


NE focusing on the neurophysiology of pain has been shown to decrease pain and disability in populations with chronic low back pain .


Eligible patients scheduled for LS for radiculopathy were randomized to receive either preoperative usual care ( UC ) or a combination of UC plus @ session of NE delivered by a physical therapist ( verbal one-on-one format ) and a NE booklet .


Sixty-seven patients completed the following outcomes prior to LS ( baseline ) , and @ , @ , @ , and @ months after LS : low back pain ( numeric rating scale ) , leg pain ( numeric rating scale ) , function ( Oswestry Disability Index ) , various beliefs and experiences related to LS ( @-item survey with Likert scale responses ) , and postoperative utilization of health care ( utilization of health care questionnaire ) .


At @-year follow-up , there were no statistical differences between the experimental and control groups with regard to primary outcome measure of low back pain ( P = @ ) , leg pain ( P = @ ) , and function ( P = @ ) .


In a majority of the categories regarding surgical experience , the NE group scored significantly better : better prepared for LS ( P = @ ) ; preoperative session preparing them for LS ( P < @ ) and LS meeting their expectations ( P = @ ) .


Health care utilization post-LS also favored the NE group ( P = @ ) resulting in @ % less health care expenditure compared with the control group in the @-year follow-up period .


NE resulted in significant behavior change .


Despite a similar pain and functional trajectory during the @-year trial , patients with LS who received NE viewed their surgical experience more favorably and used less health care facility in the form of medical tests and treatments .


To compare extra-abdominal repair of the uterine incision at cesarean delivery with in situ repair .


The present study was a double-blind randomized controlled trial conducted at a university hospital in Egypt during @-@ , and included women with an indication for cesarean delivery .


Extra-abdominal repair was used in group @ ( n = @ ) and in situ repair in group @ ( n = @ ) .


The primary outcome measure was the surgery duration .


Surgery duration was significantly longer in group @ than group @ ( @ minutes vs @ minutes ; P < @ ) .


More patients in group @ than in group @ had postoperative moderate-to-severe pain ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; P = @ ) and needed additional postoperative analgesia ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ; P < @ ) .


Moreover , mean time to bowel movement was longer in group @ than in group @ ( @ hours vs @ hours ; P < @ ) .


In situ uterine closure is more advantageous than extra-abdominal repair in terms of surgery duration , postoperative pain and need for additional analgesia , and return of bowel movement .


ClinicalTrials.gov : NCT@ .


The aim of this study was to compare the efficacy of low molecular weight heparin ( LMWH ) combined with graduated compression stockings ( GCS ) with GCS alone as prophylactic measures for venous thromboembolism ( VTE ) in post-operative patients with gynecologic cancer .


Patients diagnosed with gynecologic cancer undergoing primary major surgery between @ and @ in our institute were randomized to receive LMWH+GCS or GCS as VTE prophylaxis post-operatively .


Altogether @ patients were enrolled .


The incidence of VTE in patients treated with LMWH + GCS was significantly lower than that in patients using GCS alone ( @ % Vs. @ % , P = @ ) .


There were no severe bleeding complications in the patients with prophylactic use of LMWH and the occurrence rate of wound dehiscence was comparable between the two groups ( P > @ ) .


Multivariable logistic regression analysis revealed that age over @ years ( P = @ ) , duration of operation over @ hours ( P = @ ) and without prophylactic use of LMWH ( P = @ ) were independent risk factors for VTE .


Dual prophylaxis with LMWH and GCS should be recommended for gynecologic cancer patients undergoing major surgery for its better efficacy than GCS .


Prophylactic use of LMWH is safe and convenient .


Patients with older age and prolonged operation time are at highest risk of developing VTE post-operatively .


Until recently , very few intervention studies have investigated the effects of whole-grain cereals on postprandial glucose , insulin and lipid metabolism , and the existing studies have provided mixed results .


The objective of this study was to evaluate the effects of a @-week intervention with either a whole-grain-based or a refined cereal-based diet on postprandial glucose , insulin and lipid metabolism in individuals with metabolic syndrome .


Sixty-one men and women age range @-@ years , with the metabolic syndrome were recruited to participate in this study using a parallel group design .


After a @-week run-in period , participants were randomly assigned to a @-week diet based on whole-grain products ( whole-grain group ) or refined cereal products ( control group ) .


Blood samples were taken at the beginning and end of the intervention , both fasting and @ h after a lunch , to measure biochemical parameters .


Generalized linear model ( GLM ) was used for between-group comparisons .


Overall , @ participants in the control group and @ in the whole-grain group completed the dietary intervention .


Drop-outs ( five in the control and two in the whole-grain group ) did not affect randomization .


After @ weeks , postprandial insulin and triglyceride responses ( evaluated as average change @ and @ h after the meal , respectively ) decreased by @ % and @ % , respectively , in the whole-grain group compared to the run-in period .


Postprandial insulin and triglyceride responses were significantly lower at the end of the intervention in the whole-grain group compared to the control group ( p = @ and p = @ ; respectively ) whereas there was no change in postprandial response of glucose and other parameters evaluated .


A twelve week whole-grain cereal-based diet , compared to refined cereals , reduced postprandial insulin and triglycerides responses .


This finding may have implications for type @ diabetes risk and cardiovascular disease .


Oral ulcers , the hallmark of Behet 's syndrome , can be resistant to conventional treatment ; therefore , alternative agents are needed .


Apremilast is an oral phosphodiesterase-@ inhibitor that modulates several inflammatory pathways .


We conducted a phase @ , multicenter , placebo-controlled study in which @ patients with Behet 's syndrome who had two or more oral ulcers were randomly assigned to receive @ mg of apremilast twice daily or placebo for @ weeks .


This regimen was followed by a @-week extension phase in which the placebo group was switched to apremilast and a @-day post-treatment observational follow-up phase .


The patients and clinicians were unaware of the study assignments throughout the trial .


The primary end point was the number of oral ulcers at week @ .


Secondary outcomes included pain from these ulcers ( measured on a @-mm visual-analogue scale , with higher scores indicating worse pain ) , the number of genital ulcers , overall disease activity , and quality of life .


The mean ( SD ) number of oral ulcers per patient at week @ was significantly lower in the apremilast group than in the placebo group ( @ vs. @ ) ( P < @ ) .


The mean decline in pain from oral ulcers from baseline to week @ was greater with apremilast than with placebo ( -@ mm vs. -@ mm ) ( P < @ ) .


Nausea , vomiting , and diarrhea were more common in the apremilast group ( with @ , @ , and @ incidents , respectively , among @ patients ) than in the placebo group ( with @ , @ , and @ incidents , respectively , among @ patients ) , findings that were similar to those in previous studies of apremilast .


There were two serious adverse events in patients receiving apremilast .


Apremilast was effective in treating oral ulcers , which are the cardinal manifestation of Behet 's syndrome .


This preliminary study was neither large enough nor long enough to assess long-term efficacy , the effect on other manifestations of Behet 's syndrome , or the risk of uncommon serious adverse events .


( Funded by Celgene ; ClinicalTrials.gov number , NCT@ . )


Leg compression is considered basic treatment for superficial vein thrombosis ( SVT ) , although scientific proof for its efficacy is lacking .


The aim of the study was to evaluate the therapeutic effect of compression stockings on isolated SVT of the legs .


This was a single-center randomized controlled trial .


Eighty patients with isolated SVT of the legs were instructed to wear compression stockings ( @-@mmHg ) ( CG ) or no compression ( NCG ) for @ weeks .


All patients received low molecular weight heparin ( LMWH ) at prophylactic dosage .


Non-steroidal anti-inflammatory drugs ( NSAIDs ) were allowed .


The primary outcome variable was the reduction of pain as assessed by a visual analog scale ( VAS ) and the Lowenberg test .


Secondary outcomes were the consumption of analgesics , thrombus length , skin erythema , D-dimer , and quality of life ( QoL ) .


Seventy-three patients completed the study .


Clinical symptoms and QoL significantly improved from baseline to day @ in both groups ( p < @ for VAS , Lowenberg test , thrombus length , and erythema ; p < @ for QoL ) , and consumption of analgesics and D-dimer significantly decreased ( p < @ ) .


There was no significant difference between the groups for all tested variables .


At day @ , patients in the CG revealed a significantly faster thrombus regression ( p = @ ) .


Adding compression stockings for @ weeks to LMWH and NSAIDs does not bring significant additional benefit in the treatment of isolated SVT .


When worn for @ week , compression stockings stimulate significantly faster thrombus regression .


Two reports of infants found dead after sleeping in baby hammocks have raised international concern about the safety of infant hammocks .


We therefore tested whether hammock sleep affected oxygenation in infants , when they were at an age of high risk of sudden , unexpected infant death .


Healthy , full-term @ - to @-week-old infants were randomised to sleep either in a commercially available hammock ( n = @ ) or a standard bassinet ( n = @ ) , and sleep state , oxygen desaturation ( a fall in peripheral haemoglobin oxygen saturation ( SpO@ ) @ % , for @ sec from baseline to nadir ) , apnoea and hypopnoea , and mean SpO@ were analysed .


There was no significant difference in mean SpO@ ( both @ % ) or rate of oxygen desaturation events between the hammock and the bassinet cot ( mean SD , @ @ vs. @ @ events per hour ) , but infants slept less in the hammock ( @ @ vs. @ @ min , p < @ ) .


When correctly used , the hammock sleep position did not compromise the upper airway of sleeping infants .


The significance of shorter duration of sleep in the hammocks is unclear .


These findings should not be applied to all baby hammocks , nor to older babies , particularly once the infant can roll .


Given that it is not possible to predict when an infant will be able to roll , we strongly recommend that hammocks should not be used for unsupervised sleep .


To explore the effects of reconstructing method ( narrow gastric tube ( NGT ) versus whole stomach ( WS ) ) on health-related quality of life ( HRQL ) in patients during a @-year follow-up .


In a prospective randomized single-center study from @ to @ , @ patients underwent esophagectomy for cancer .


They were divided into NGT ( n = @ ) and WS ( n = @ ) groups .


To assess HRQL , a questionnaire in references to EORTC-QLQ-C@ and QLQ-OES@ was administered at @ weeks , @ months , @ year , @ year and @ years post-operation .


Their clinical data were collected prospectively and follow-up was performed regularly .


The patients in the NGT group reported significantly ( P < @ ) better average scores of HRQL at both @ months and @ year.However , no significant difference in average scores of HRQL was found at @ years .


Patients in the NGT group reported significantly ( P < @ ) better scores of reflux at @ weeks , @ months and @ year.Nausea was the only item with significant difference on HRQL at @ years and @ years.No significant difference existed between two groups with regards to cumulative survival rate at @ years .


No significant difference existed between two groups with regards to cumulative survival rate at @ years .


The patients with gastric tube reconstruction after oncologic esophagectomy present better HRQL.Further studies are warranted to perform survival analysis beyond @ year post-operation .


It was to test the validity and reliability of an online version of the Female Sexual Function Index ( FSFI ) .


An online version of the FSFI was compared to the pen and paper traditional version .


Physiotherapy students in three cities were randomly allocated to two groups - G-pp/ol ( n = @ ) and G-ol/pp ( n = @ ) .


G-pp/ol women replied to th FSFI using the traditional pen and paper method , while G-ol/pp women answered an online version of the same questionnaire .


Data were collected ageing after @ days , when G-pp/ol women answered the online version while G-ol/pp women answered on paper .


All data were transferred to SPSS software .


Demographic differences between the test two groups were determined by Student 's t-test or Fisher exact ( @ % CI ; p > @ ) .


Association and correlation between the responses of G-pp/ol and G-ol/pp were assessed for each sample by the t-test and Pearson 's coefficient .


An identical strategy was used for intragroup comparisons .


A total of @ women participated in the study and @ ( @ % ) giving up the second collection .


There were no demographic differences between groups .


Fifteen of the @ FSFI questions were associated and correlated between the two groups in both test and the retest .


The intragroup analysis revealed that all FSFI questions and scores were associated and weakly correlated for the same group during both test and retest .


The online version of the FSFI showed acceptable validity and reliability when compared to the paper version , and can justify the choice of this modality , especially in studies involving private questions .