Citrate confers less filter-induced , potentially harmful complement activation and neutrophil degranulation and less endothelial activation than heparin when used for anticoagulation during continuous venovenous haemofiltration in critically ill patients .


Prospective , single-blinded , and randomized clinical trial .


This study evaluates the added benefit of promethazine administration as an anxiolytic adjunct to morphine analgesia in reducing acute low back pain ( LBP ) compared with morphine alone .


Acute LBP is one of the most common reasons for emergency department ( ED ) visits .


The optimal analgesic treatment for acute LBP remains controversial .


Anxiety relief has been shown to improve pain management in the ED setting .


We hypothesized that administration of the antihistamine promethazine as an anxiolytic adjunct to morphine analgesia will improve LBP management compared with morphine alone .


Fifty-nine adults , who were treated in our ED for severe acute LBP ( visual analogue scale @ mm ) , were randomly enrolled in the study .


Thirty patients received slow infusion of intravenous ( IV ) morphine @ mg/kg in normal saline and @ patients received an analgesic regimen of IV morphine @ mg/kg with promethazine @ mg administered similarly .


Pain and anxiety levels were subjectively assessed by the patients on a @-mm visual analogue scale before and after treatment .


Adverse event related to analgesia were recorded in real time .


After analgesia administration patients ' pain rating decreased by @ mm in the morphine group and by @ mm in the morphine/promethazine group ( P = @ ) .


Similarly , patients ' anxiety decreased by @ mm in the morphine group and by @ mm in the morphine/promethazine group ( P = @ ) .


The average ED stay was @ minutes longer in the morphine/promethazine group ( P = @ ) , due to the strong sedative effect of promethazine .


Patients ' satisfaction and the rate of adverse events were similar in both groups .


IV administration of morphine-promethazine regimen for pain and anxiety relief associated with acute LBP showed no advantage compared with IV morphine alone and significantly lengthened the overall ED stay .


Thus , we think that promethazine has no place in acute LBP management in the adult ED setting .


To evaluate the long-term effectiveness of presurgical therapy with GnRH analogues in patients who underwenthydrothermal endometrial ablation ( HTA ) for menorrhagia and assess the relationship between sonographically measured myometrium thickness and pelvic pain .


A prospective randomized control study comparing @ women ( Group A ) with presurgical subcutaneous triptorelin depot injection before HTA with controls ( Group B , n = @ ) .


Inclusion criteria were : recurrent menorrhagia , uterus length < @ cm , no previous hormonal therapy for at least six month , and family plan completed .


Student 's t test was applied , as appropriate , to compare continuous variables .


Proportion were compared with chi-squared .


After @ months of follow-up , Group A showed a significantly lower ( @ % vs @ % ; p = @ ) failure rate after hydrothermoablation than the Group B and a generally higher successful rate at @ and @ months .


The discomfort , evaluated with VAS , showed a mean value of @ + / - @ + / - SD ) ; @ % of women reported a mild-moderate postoperative pain .


No perioperative and late complications were recorded .


Presurgical treatment with GnRH analogues seems to improve long-term efficacy of HTA .


Perioperative pelvic pain seems to not be affected by myometrium thickness .


Data are inconsistent regarding the associations between age , age at diagnosis of diabetes , diabetes duration and subsequent vascular complications .


The associations between age ( or age at diagnosis ) , diabetes duration and major macrovascular events , all-cause death and major microvascular events were examined in @,@ patients with type @ diabetes randomly allocated to intensive or standard glucose control in the Action in Diabetes and Vascular Disease : Preterax and Diamicron Modified Release Controlled Evaluation ( ADVANCE ) trial .


Rates were calculated by @ year baseline age ( or age at diagnosis ) and diabetes duration strata .


Risks were estimated using Cox models adjusted for treatment assignment and HbA@c .


The mean age ( SD ) was @ years , age at diagnosis was @ years and diabetes duration was @ years .


Diabetes duration was associated with the risk of macrovascular events ( HR @ -LSB- @ % CI @ , @ -RSB- ) , microvascular events ( @ -LSB- @ , @ -RSB- ) and death ( @ -LSB- @ , @ -RSB- ) whereas age ( or age at diagnosis ) was only associated with the risk of macrovascular events ( @ -LSB- @ , @ -RSB- ) and death ( @ -LSB- @ , @ -RSB- ) .


No interaction was observed between diabetes duration , age and the risk of macrovascular events or death ( both p > @ ) .


However , an interaction was observed between diabetes duration , age and the risk of microvascular events ( p = @ ) , such that the effects of increasing diabetes duration were greatest at younger rather than older age .


In patients with type @ diabetes , age or age at diagnosis and diabetes duration are independently associated with macrovascular events and death whereas only diabetes duration is independently associated with microvascular events and this effect is greater in the youngest patients .


Electrotherapy , including theTENS and interferential current ( IFC ) is one of the most frequently used treatments in physical therapy in patients with low back pain .


The aim of this study was to assess the influence of TENS and IFC on pain relief and to compare the analgesic efficacy of the two currents .


Sixty patients aged @ @ , with low back pain , were randomly divided into two groups : IFC ( gr .


I ) and TENS ( gr .


II ) .


Depending on the groups , patients were given series of ten @-minute sessions using either IF orTENS currents .


In all patients VAS and Laitinen modified scale were taken before and after treatment .


After @-weeks therapy there was improvement in the VAS and Laitinen scale ( all components ) in both groups , except for the part of the Laitinen scale on the reduction of activity in the group II ( TENS ) .


There was no statistically significant difference between the TENS and IF groups in reducing the intensity and other aspects of pain ( frequency , pain medication and activity limitation ) under the influence of therapy ( p > @ ) .


Interferential current and TENS therapy are effective for pain relief in patients with low back pain .


The study showed equal analgesic efficacy of both treatments .


Limited options are available for the treatment of brittle nail syndrome .


To assess the efficacy and safety of topical cyclosporine emulsion ( CsAE ) versus emulsion ( vehicle ) alone in the treatment of brittle nail syndrome .


Twenty-four patients were randomized to topical CsAE emulsion or emulsion ( vehicle ) for @ weeks .


Four fingernails of each patient were included ; the @ most severe brittle nails and the second most normal nail were treated with the same medication .


The fourth nail , the most normal nail , remained untreated and was used to assess nail growth .


The prespecified primary endpoint was change from baseline in Physician Global Assessment ( PGA ) score ( @ to @ scale ) at each follow-up visit .


Safety evaluations were conducted at each visit .


In the intent-to-treat population ( n = @ for each treatment arm ) , the PGA score for treated nails improved from baseline ( CsAE , @ to @ ; emulsion , @ to @ ; P < @ for each ) , with no significant between-group differences .


Untreated nails did not improve in overall appearance ( @ to @ grade ; P > @ ) .


Statistically and clinically significant improvement from baseline was reported for nail length/appearance in both CsAE and vehicle groups .


Sample size was relatively small .


The difference in PGA between treated and untreated nails was not analyzed .


Baseline disease severity may have been too mild , limiting detection of efficacy .


Both CsAE and emulsion vehicle applied topically appeared to improve signs and symptoms of brittle nail syndrome and were well tolerated .


These findings warrant corroboration in a larger population and inclusion of comparison with an inactive control and a higher concentration of CsAE , the former which may help in distinguishing the efficacy of vehicle emulsion from CsAE .


Phosphodiesterase ( PDE ) enzymes , including members of PDE@ , have been investigated in the regulation of endocrine and reproductive functions of ovaries .


In addition , selective inhibition of PDE@ enzyme has recently been implicated in the regulation of metabolism with positive effects on glucose homeostasis and weight reduction .


The aim of this study was to evaluate whether the PDE@ inhibitor roflumilast affects body weight and hormonal and metabolic status in obese women with polycystic ovary syndrome ( PCOS ) .


Design/Participants/Main Outcome Measures : A @-week prospective randomized open-label study was conducted with @ obese women with PCOS diagnosed by the National Eunice Kennedy Shriver Institute of Child Health and Human Development criteria that had been pretreated with metformin ( MET ) .


They were randomized to MET @ mg twice a day or combined treatment ( COM ) with MET @ mg twice a day and roflumilast @ g every day .


The primary outcome was change in anthropometric measures of obesity .


Thirty-one patients ( aged @ @ y , twice a day @ @ kg/m ( @ ) , mean SD ) completed the study : @ on MET and @ on COM .


Subjects treated with COM lost on average @ @ kg compared with a @ @ kg weight gain in the MET group ( P = @ ) .


Body mass index decreased for @ @ kg/m ( @ ) in COM arm compared with increase for @ @ kg/m ( @ ) in the MET arm ( P = @ ) .


Visceral adipose tissue area as assessed by dual-energy x-ray absorptiometry decreased from @ @ to @ @ cm ( @ ) in the COM arm compared with an increase from @ @ to @ @ cm ( @ ) in the MET arm ( P = @ ) .


From baseline to study end , both treatment interventions resulted in a significant reduction of androstenedione ( P = @ ) , free T ( P = @ ) , and homeostasis model assessment for insulin resistance score ( P = @ ) and a significant increase in SHBG ( P = @ ) , although the between-treatment differences of the changes have not been statistically significant yet .


Roflumilast added to metformin reduced body weight in obese women with PCOS , primarily due to a loss of fat mass .


Randomized controlled trials specifically designed to assess inflammation-related outcomes in response to dairy consumption are lacking .


We investigated the impact of dairy food consumption on biomarkers of inflammation in healthy men and women with low-grade systemic inflammation .


In a multicenter randomized crossover study , @ adult men and women with high-sensitivity C-reactive protein ( hs-CRP ) values > @ mg/L consumed @ servings/d of dairy ( @ mL low-fat milk , @ g low-fat yogurt , and @ g regular-fat cheddar cheese ) or energy-matched control ( fruit juice , vegetable juice , cashews , and @ cookie ) products as part of prudent @-wk diets , each separated by a @ - to @-wk washout period .


Serum concentrations of inflammation biomarkers were measured at the beginning and end of each dietary phase .


Expression levels of key inflammatory genes and transcription factors in whole blood cells were assessed at the end of each diet by real-time polymerase chain reaction in a random subset of @ subjects .


Analysis of within-diet changes ( post - vs. prediet values ) showed a significant reduction in hs-CRP concentrations after the control diet ( -@ % , P = @ ) but no change after the dairy diet ( -@ % , P = @ ) .


As a result , changes in hs-CRP differed between the dairy and control diets ( P = @ ) .


Both the control and dairy diets similarly reduced interleukin-@ concentrations compared with diet-specific baseline values ( -@ % and -@ % , respectively ; P < @ for both , P = @ for between-diet comparison ) .


No between - or within-diet difference was observed in adiponectin concentrations , and there was also no between-diet difference in the expression of inflammatory genes and transcription factors .


Consistent with data from previous work , these results suggest that short-term consumption of a combination of low - and high-fat dairy products as part of a healthy diet has no adverse effects on inflammation .


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


Hepatic lipase ( HL ) plays a pivotal role in the metabolism of HDL and LDL .


Recent genome-wide association studies have identified common variants in the HL gene ( LIPC ) associated with HDL cholesterol .


We tested the effect of a common variant in LIPC on changes in blood lipids in response to weight-loss diets in the Preventing Overweight Using Novel Dietary Strategies Trial .


We genotyped LIPC rs@ in @ overweight or obese adults aged @-@ y ( @ % women ) who were assigned to high-fat ( @ % energy ) or low-fat ( @ % energy ) diets for @ y.


We measured serum concentrations of total cholesterol ( TC ) , triglycerides , LDL cholesterol , and HDL cholesterol at baseline and @ y of intervention .


At @ y of intervention , dietary fat modified effects of the variant on changes in serum TC , LDL cholesterol , and HDL cholesterol ( P-interaction : @ , @ , and @ , respectively ) .


In the low-fat group , as compared to the G allele , the A allele tended to be related to the decrease in TC and LDL cholesterol concentrations -LSB- TC ( SE ) : -@ @ , P = @ ; LDL cholesterol : -@ @ , P = @ -RSB- and a lower increase in HDL cholesterol concentrations ( SE : -@ @ , P = @ ) , whereas an opposite effect in the high-fat diet group was evident -LSB- TC ( SE ) : @ @ , P = @ ; LDL cholesterol : @ @ , P = @ -RSB- , and there was no genetic effect on changes in HDL cholesterol concentrations ( P = @ ) .


Dietary fat intake modifies the effect of a common variant in LIPC on changes in serum lipids during a long-term weight-loss intervention in overweight or obese adults .


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


To explore the clinical efficacy of open-door cervical laminoplasty combined Modified Buyang Huanwu Decoction ( MBHD ) to treat cervical spinal canal stenosis ( CSCS ) .


Totally @ CSCS patients were randomly assigned to two groups , Group A ( @ cases , treated by laminoplasty ) and Group B ( @ cases , treated by laminoplasty combined MBHD ) .


All patients received open-door cervical laminoplasty .


Those in Group B took MBHD additionally for @ weeks after surgery .


The visual analogue scale ( VAS ) , the Japanese Orthopedic Association ( JOA ) score , and the neck disability index ( NDI ) were measured preoperative , postoperative @ months and @ months , respectively .


There was no statistical difference in preoperative VAS , JOA , or NDI ( P > @ ) .


The VAS , JOA , and NDI were obviously improved @ months and @ months after surgery in the two groups , showing statistical difference when compared with before surgery in the same group ( P < @ ) .


At @ months after surgery the aforesaid indices in Group B were superior to those in Group A ( P < @ ) .


There was no statistical difference in the aforesaid indices between the two groups at @ months after surgery ( P > @ ) .


MBHD favorably improved early recovery of neural functions of CSCS patients ( @ months after surgery ) .


Increased levels of reactive oxygen species during and after surgery may affect inflammatory response , post-operative adhesion molecule formation , and hemodynamic stability .


The glutathione redox cycle is an important regulator in oxidative stress and its reduced forms scavenge free radicals .


N-acetyl cysteine , a precursor of reduced glutathione , is considered as a potentially therapeutic wide spectrum agent in clinical practice .


We therefore examined whether N-acetyl cysteine improves some biochemical parameters in cancer patients undergoing major abdominal surgery .


Thirty-three patients diagnosed with pancreas , stomach , rectum , colon malignancies , and undergoing major abdominal surgery at Ankara Numune Training and Research Hospital were randomly divided into two groups ; control ( CON ) and N-acetyl cysteine ( NAC ) .


The NAC group had @,@mgN-acetyl cysteine starting two days before the operation day , in addition to isonitrogenous and isocaloric total parenteral nutrition of @ g/kg protein , @kcal/kg , and @:@ carbohydrate/fat ratio .


Blood and urine samples were drawn two days before the operation , on operation day , and on the first , third , and fifth days post-operation .


Plasma malondialdehyde was significantly lower in the NAC group ( P < @ ) .


N-acetyl cysteine treatment did not affect plasma levels of vitamin A , C or E.


The NAC group exhibited a higher ratio of reduced glutathione to oxidised glutathione ( P = @ ) .


Urinary nitrate level was also significantly lower in the NAC group ( P = @ ) .


The study demonstrated the clinical importance of N-acetyl cysteine supplementation on antioxidant parameters in abdominal surgery patients .


In these patients N-acetyl cysteine and vitamin administration can be considered as an effective method for improvement of oxidative status .


In our randomised , controlled , phase @ trial NeOAdjuvant Herceptin ( NOAH ) trial in women with HER@-positive locally advanced or inflammatory breast cancer , neoadjuvant trastuzumab significantly improved pathological complete response rate and event-free survival .


We report updated results from our primary analysis to establish the long-term benefit of trastuzumab-containing neoadjuvant therapy .


We did this multicentre , open-label , randomised trial in women with HER@-positive locally advanced or inflammatory breast cancer .


Participants were randomly assigned ( @:@ ) , by computer program with a minimisation technique , to receive neoadjuvant chemotherapy alone or with @ year of trastuzumab ( concurrently with neoadjuvant chemotherapy and continued after surgery ) .


A parallel group with HER@-negative disease was included and received neoadjuvant chemotherapy alone .


Our primary endpoint was event-free survival .


Analysis was by intention to treat .


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


Between June @ , @ , and Dec @ , @ , we enrolled @ patients with HER@-positive disease , of whom @ received chemotherapy alone and @ received chemotherapy plus trastuzumab .


@ additional patients with HER@-negative disease were included in the parallel cohort .


After a median follow-up of @ years ( IQR @-@ @ ) the event-free-survival benefit from the addition of trastuzumab to chemotherapy was maintained in patients with HER@-positive disease .


@ year event-free survival was @ % ( @ % CI @-@ ) in patients in the trastuzumab group and @ % ( @-@ ) in those in the chemotherapy group ; the unadjusted hazard ratio ( HR ) for event-free survival between the two randomised HER@-positive treatment groups was @ ( @ % CI @-@ @ ; two-sided log-rank p = @ ) .


Event-free survival was strongly associated with pathological complete remission in patients given trastuzumab .


Of the @ patients with a pathological complete response ( @ with trastuzumab and @ with chemotherapy alone ) , the HR for event-free survival between those with and without trastuzumab was @ ( @ % CI @-@ @ ) .


During follow-up only four cardiovascular adverse events were regarded by the investigator to be drug-related ( grade @ lymphostasis and grade @ lymphoedema , each in one patient in the trastuzumab group , and grade @ thrombosis and grade @ deep vein thrombosis , each in one patient in the chemotherapy-alone group ) .


These results show a sustained benefit in event-free survival from trastuzumab-containing neoadjuvant therapy followed by adjuvant trastuzumab in patients with locally advanced or inflammatory breast cancer , and provide new insight into the association between pathological complete remission and long-term outcomes in HER@-positive disease .


A better understanding of the stroke risk factors in children with congenital heart disease ( CHD ) could inform stroke prevention strategies .


We analyzed pediatric stroke associated with CHD in a large community-based case-control study .


From @ million children ( aged < @ years ) enrolled in a Northern California integrated healthcare plan , we identified children with ischemic and hemorrhagic strokes and randomly selected age - and facility-matched stroke-free controls ( @ per case ) .


We determined exposure to CHD ( diagnosed before stroke ) and used conditional logistic regression to analyze stroke risk factors .


CHD was identified in @ of @ cases ( @ % ) versus @ of @ controls ( @ % ) .


Cases of childhood stroke ( occurring between ages @ days to @ years ) with CHD had @-fold ( odds ratio , @ ; @ % confidence interval @-@ ) increased stroke risk compared to controls .


History of CHD surgery was associated with > @-fold ( odds ratio , @ ; confidence interval @-@ ) increased risk of stroke in children with CHD when compared with controls .


After excluding perioperative strokes , the history of CHD surgery still increased the childhood stroke risk ( odds ratio , @ ; confidence interval @-@ ) .


The majority of children with stroke and CHD were outpatients at the time of stroke , and almost half the cases who underwent cardiac surgery had their stroke > @ years after the most recent procedure .


An estimated @ % of ischemic and @ % of hemorrhagic childhood strokes in the population were attributable to CHD .


CHD is an important childhood stroke risk factor .


Children who undergo CHD surgery remain at elevated risk outside the perioperative period and would benefit from optimized long-term stroke prevention strategies .


To analyze differences in the cost of treatment for infants randomized to primary intraocular lens ( IOL ) implantation versus optical correction with a contact lens ( CL ) after unilateral cataract surgery in the Infant Aphakia Treatment Study ( IATS ) .


Retrospective cost analysis of a prospective , randomized clinical trial based on Georgia Medicaid reimbursement data as well as actual costs of supplies used during the study , adjusted for inflation .


The IATS is a multicenter ( n = @ ) , randomized clinical trial comparing the optical treatment of aphakia with either primary IOL implantation ( n = @ ) or CL correction ( n = @ ) in @ infants with unilateral congenital cataract .


One hundred fourteen infants underwent unilateral cataract surgery and were either corrected optically by primary IOL implantation at the time of surgery or were corrected with a CL after surgery .


The mean cost of cataract surgery and all additional surgeries , examinations , and supplies used up to @ years of age .


The @-year treatment cost of an infant with a unilateral congenital cataract corrected optically with an IOL was $ @ @ versus $ @ @ for a patient treated with a CL after initial cataract surgery .


The total cost of supplies was $ @ in the IOL group versus $ @ in the CL group .


Unilateral cataract surgery in infancy coupled with primary IOL implantation is approximately @ % more expensive than aphakia and CL correction .


Patient costs are more than double with CL versus IOL treatment .


Paclitaxel and gemcitabine ( PG ) combination chemotherapy is effective as a maintenance chemotherapeutic regimen in metastatic breast cancer ( MBC ) patients because it increases progression-free survival ( PFS ) , which increases overall survival ( OS ) .


The primary purpose of our study was to investigate the association between genetic polymorphisms in the genes involved in PG pathways and clinical outcomes in MBC patients treated with PG chemotherapy .


A total of @ MBC patients were enrolled in this prospective multicenter trial of PG as the first-line chemotherapy .


Eighty-five of the @ patients from two institutes were available for analysis of single nucleotide polymorphisms ( SNPs ) .


Germline DNA was extracted from peripheral blood mononuclear cells .


Thirty-eight SNPs in @ candidate genes selected from pathways that may influence the metabolism and transport of , or sensitivity , to PG were analysed .


The median PFS and OS of all @ patients were @ months ( @ % confidence interval -LSB- CI -RSB- : @-@ @ months ) and @ months ( @ % CI : @-@ @ months ) , respectively .


An SNP in SLC@A@ ( rs@ , C/T ) was associated with OS ( CC or CT versus TT : @ versus @ months , p = @ , hazard ratio -LSB- HR -RSB- @ , @ % CI : @-@ @ ) .


SLC@A@ GA haplotype had a significantly shorter OS ( p = @ , HR @ , @ % CI : @-@ @ ) .


RRM@ ( ribonucleotide reductase large subunit M@ ) SNP ( rs@ ) , and haplotypes ATAA and ATGA were significantly associated with neurotoxicity .


Genetic polymorphisms in SLC@A@ , SLC@A@ and RRM@ can influence the clinical outcome of MBC patients treated with PG chemotherapy .


Further studies on the functional mechanisms relating to these germline polymorphisms in these genes are warranted .


JTT-@ is a novel phosphate binder containing ferric citrate as the active ingredient .


In this Phase @ , multicenter , randomized , open-label , parallel-group study , we compared the efficacy and safety of JTT-@ and sevelamer hydrochloride in patients undergoing hemodialysis .


A total of @ patients with a serum phosphate @ and < @ mmol/L were randomized to JTT-@ ( dose adjusted between @ and @ g/day ) or sevelamer hydrochloride ( dose adjusted between @ and @ g/day ) for @ weeks .


The primary outcome was change in serum phosphate from baseline to end of treatment .


Secondary outcomes included the changes in corrected serum calcium and intact parathyroid hormone ( PTH ) .


The changes in ferritin , transferrin saturation and erythropoiesis-stimulating agent dose were additional outcomes .


Changes in serum phosphate at the end of treatment were -@ mmol/L in the JTT-@ group and -@ mmol/L in the sevelamer group , establishing non-inferiority of JTT-@ compared with sevelamer ( least squares mean , -@ mmol/L ; @ % confidence interval , -@ to @ mmol/L ) .


Corrected serum calcium increased and PTH decreased from baseline within both groups ; changes between groups were similar .


Gastrointestinal disorders were the most common adverse events in both groups ; the incidence of diarrhea was higher in the JTT-@ group , while constipation occurred frequently in the sevelamer group .


Treatment with JTT-@ resulted in significant relative increases in serum ferritin and transferrin saturation .


Efficacy and safety of JTT-@ was comparable to sevelamer in patients on hemodialysis with hyperphosphatemia .


Differential adverse effects were observed ; biochemical markers of iron status increased in patients treated with JTT-@ .


Little is known as to whether primary care teams ' perceptions of how well they have implemented the Chronic Care Model ( CCM ) corresponds with their patients ' own experience of chronic illness care .


We examined the extent to which practice members ' perceptions of how well they organized to deliver care consistent with the CCM were associated with their patients ' perceptions of the chronic illness care they have received .


Analysis of baseline measures from a cluster randomized controlled trial testing a practice facilitation intervention to implement the CCM in small , community-based primary care practices .


All practice `` members '' ( i.e. , physician providers , non-physician providers , and staff ) completed the Assessment of Chronic Illness Care ( ACIC ) survey and adult patients with @ or more chronic illnesses completed the Patient Assessment of Chronic Illness Care ( PACIC ) questionnaire .


Two sets of hierarchical linear regression models accounting for nesting of practice members ( N = @ ) and patients ( N = @,@ ) within @ practices assessed the association between practice member perspectives of CCM implementation ( ACIC scores ) and patients ' perspectives of CCM ( PACIC ) .


ACIC summary score was not significantly associated with PACIC summary score or most of PACIC subscale scores , but four of the ACIC subscales -LSB- Self-management Support ( p < @ ) ; Community Linkages ( p < @ ) , Delivery System Design ( p < @ ) , and Organizational Support ( p < @ ) -RSB- were consistently associated with PACIC summary score and the majority of PACIC subscale scores after controlling for patient characteristics .


The magnitude of the coefficients , however , indicates that the level of association is weak .


The ACIC and PACIC scales appear to provide complementary and relatively unique assessments of how well clinical services are aligned with the CCM .


Our findings underscore the importance of assessing both patient and practice member perspectives when evaluating quality of chronic illness care .


Copper IUD is a long term and reversible contraception which equals tubal ligation in terms of sterilization .


One of the barriers to using this contraception method is the fear and the pain associated with its insertion .


Eutectic mixture of local anesthetics ( EMLA ) @ % is a local anesthetic that contains @ mg lidocaine and @ mg of prilocaine per gram .


Application of topical analgesic cream to the cervix for laser surgery , hysteroscopy and hysterosalpingography is known Aims : this study aimed to determine the effect of EMLA on IUD insertion pain .


This triple blind clinical trial was conducted on @ women in a clinic in Hamedan in @ .


After applying the cream on the cervix , pain in three steps , after using Tenaculum , after inserting hystrometr and after inserting IUD and removing IUD insertion tube were assessed with visual analog scale and were compared in EMLA group and placebo group Statistical analysis used to determine and compare the pain of independent t tests , Mann-Whitney U test and repeated measures analysis of variance and chi-square tests to determine the homogeneity of variables and Fisher 's exact test was used .


Insertion hystrometr was determined as the most painful IUD insertion .


The mean pain at step @ ( inserting hystrometr ) was ( @ ) in EMLA group , ( @ ) in placebo group .


EMLA cream significantly reduced the pain after using tenaculum ( P < @ ) , pain inserting Hystrometr ( P < @ ) and pain at IUD insertion and removing insertion tube ( P < @ ) CONCLUSIONS : Topical Application of EMLA @ % cream as a topical anesthetic on the cervix before insertion IUD reduced the pain during this procedure .


To evaluate how much the improvement of lower urinary tract symptoms ( LUTS ) affects sexual function and which storage symptoms or voiding symptoms have the greatest effect on sexual function .


A total of @ patients were enrolled in this study .


Patients were randomly assigned to receive either tamsulosin @ mg ( group A ) or tamsulosin @ mg and solifenacin @ mg ( group B ) .


At @ weeks and @ weeks , the LUTS and sexual function of the patients were evaluated by use of the International Index of Erectile Function-@ ( IIEF@ ) , International Prostate Symptom Score ( IPSS ) , Overactive Bladder Symptom Score ( OABSS ) questionnaire , uroflowmetry , and bladder scan .


Both groups A and B showed statistically significant improvements in IPSS , OABSS , and quality of life ( QoL ) .


Group A showed improved maximum flow rate , mean flow rate , and residual urine volume by time .


Group B did not show an improvement in flow rate or residual urine volume but total voiding volume increased with time .


The IIEF@ score was not improved in either group .


In group A , the IIEF@ score dropped from @ @ to @ @ after @ weeks ( p = @ ) .


Group B showed a decline in the IIEF@ score from @ @ to @ @ ( p = @ ) .


Although group B showed a relatively smaller decrease in the IIEF@ score , the difference between the two groups was not significant ( p = @ ) .


Tamsulosin monotherapy and combination therapy with solifenacin did not improve erectile function despite improvements in voiding symptoms and QoL .


The improvement in storage symptoms did not affect erectile function .


We evaluate the effect of the protoconized anemia therapy on adverse events using the Hb and ferritin levels of individual patients undergoing maintenance hemodialysis ( MHD ) .


Design : A randomized , parallel group , multi-center study .


Two hundred sixty-six MHD patients .


Intervention group : The doses of erythropoietin , iron , and vitamin C were adjusted every month based on the ferritin and hemoglobin ( Hb ) levels according to the protocol .


Non-intervention group : The attending physician determined the doses of erythropoietin and iron .


The maintenance rate of target Hb and ferritin levels were significantly higher in the Intervention group than in the Non-intervention group .


The frequency of hospitalization was significantly lower for patients with a higher maintenance rate of target Hb levels than for those with a lower maintenance rate .


Using an anemia treatment protocol according to the individual Hb and ferritin levels of hemodialysis patients might stabilize the Hb and ferritin levels , which in turn could contribute to the lower frequency of adverse events in MHD patients .


The impact of long-acting calcium channel blocker ( CCB ) administration on serial changes in left ventricular ( LV ) function and morphology in hypertensive patients with LV hypertrophy remains unclear .


This study attempted to clarify this impact by comparing the effects of administration of azelnidipine with that of amlodipine using conventional and speckle tracking echocardiography .


An equal number ( @ ) of @ hypertensive patients was prospectively assigned to a group administered @ mg of amlodipine/day or a group administered @ mg of azelnidipine/day .


LV function and morphology was examined by conventional and speckle tracking echocardiography at baseline and at @ , @ , @ , and @ months after treatment initiation .


Both groups were found to have experienced a significant decrease in systolic blood pressure by @ month after treatment initiation ; a significant reduction in septal thickness and LV mass index at @ and @ months .


Transmitral flow E/A ratio and early diastolic mitral annular velocity at lateral wall significantly improved at @ months .


On the other hand , a significant improvement of global longitudinal strain was observed earlier than the above indexes at @ , @ , and @ months .


Ar-A duration difference was significantly decreased at @ months .


The global circumferential strain improved significantly at @ months , but there were no significant changes in mid - / apical circumferential and radial strains throughout the study period .


Azelnidipine has beneficial effects on LV mass regression , transmitral flow , tissue Doppler , and LV longitudinal strain that are comparable to those of amlodipine on the same parameters .


To observe the clinical efficacy of sodium cromoglicate eye drops combined with Yupingfeng granules in the treatment of allergic conjunctivitis .


A total of @ patients with allergic conjunctivitis were randomly divided into a combined sodium cromoglicate and Yupingfeng Granule ( treatment ) group ( n = @ ) and a sodium cromoglicate ( control ) group ( n = @ ) .


Clinical efficacy of the two treatments was evaluated by observing the changes in patients ' symptoms and physical signs before and after their respective treatments .


Following treatment , the symptoms and physical signs related to allergic conjunctivitis were significantly alleviated in all @ cases .


The total efficacy of the combined sodium cromoglicate and Yupingfeng granule treatment was @ % , which was significantly higher than the value of @ % obtained with sodium cromoglicate alone ( P < @ ) .


Combined therapy of sodium cromoglicate eye drops and Yupingfeng granules had a high efficacy and no significant adverse reactions .


Therefore , this treatment deserves to be considered for wide application in clinical settings .


To examine if implicit emotion regulation ( occurring outside of awareness ) is related to binge eating disorder ( BED ) symptomatology and explicit emotion regulation ( occurring within awareness ) , and can be altered via intervention .


Implicit emotion regulation was assessed via the Emotion Conflict Task ( ECT ) among a group of adults with BED .


Study @ correlated BED symptomatology and explicit emotion regulation with ECT performance at baseline ( BL ) and after receiving BED treatment ( PT ) .


Study @ generated effect sizes comparing ECT performance at BL and PT with healthy ( non-eating disordered ) controls ( HC ) .


Study @ yielded significant correlations ( p < @ ) between both BED symptomatology and explicit emotion regulation with ECT performance .


Study @ found that compared to BL ECT performance , PT shifted ( d = -@ ) , closer to HC .


Preliminary results suggest a ) BED symptomatology and explicit emotion regulation are associated with ECT performance , and b ) PT ECT performance normalized after BED treatment .


Implicit emotion regulation may be a BED treatment mechanism because psychotherapy , directly or indirectly , decreased sensitivity to implicit emotional conflict .


Further understanding implicit emotion regulation may refine conceptualizations and effective BED treatments .


The purpose of our study was to investigate the effects of Kinesio Taping ( ) Application with Complex Decongestive Therapy ( CDT ) in patients with lymphedema .


@ patients were randomly divided into @ groups ( CDT including Bandage , CDT including Bandage + Kinesio Tape ( ) , CDT including Kinesio Tape ( ) without bandage ) .


Assessments included the severity of the symptoms such as pain , discomfort , heaviness , tension , stiffness and weakness .


Bilateral circumference measurements were done for evaluation of the edema .


Symptoms were decreased in all three groups ( p < @ ) .


CDT was found effective only during treatment in arm volume ( p < @ ) .


Kinesio Taping ( ) applied with CDT had effect of decreasing edema after @ days of treatment period ( p < @ ) and for control period ( p < @ ) .


Only the application of Kinesio Taping ( ) group also had significant decrease at edema ( p < @ ) .


Kinesio Taping ( ) Application along with CDT may have a better effect on decreasing lymphedema which can stimulate the reduction of edema for long term effects .


To study the efficacy of short-term educational intervention for parents of preschool children with anxiety .


Forty-nine children with Spence Preschool Anxiety Scale ( SPAS ) scores of @ were randomly divided into intervention and control groups .


The children 's parents in the intervention group received a collective curriculum on children 's anxiety management six times , while the control group was only followed up .


All children were evaluated for anxiety by the SPAS @ and @ months later , and then the results were compared between the two groups .


The test was completed in @ cases of the intervention group and @ cases of the control group .


At month @ , the intervention group had a significantly lower percentage of children with SPAS scores of @ than the control group ( @ % vs @ % ; P < @ ) , and this percentage was also significantly lower in the intervention group than in the control group at month @ ( @ % vs @ % ; P < @ ) .


At month @ , the intervention group had a significantly reduced mean SPAS score , which was significantly lower than that of the control group ( @ @ vs @ @ ; P < @ ) .


At month @ , both groups showed significant decreases in SPAS score , but still the SPAS score was significantly lower in the intervention group than in the control group ( @ @ vs @ @ ; P < @ ) .


Early short-term education for parents can relieve their preschool children 's anxiety effectively , but the long-term effect needs to be evaluated by follow-up .


To report penile integrity measures , including stretched penile length ( SPL ) , from a randomized , double-blind , double-dummy , placebo-controlled trial evaluating treatment with tadalafil initiated after nerve-sparing radical prostatectomy ( nsRP ) .


Patients aged @ years were randomized after nsRP @:@:@ to @-month double-blind treatment ( DBT ) with tadalafil @ mg once daily ( OaD ) , @-mg tadalafil on-demand ( `` pro-re-nata '' ; PRN ) , or placebo , followed by @-week drug-free washout and @-month open-label OaD treatment .


Secondary outcome measures included the change in SPL from pre-nsRP to the end of DBT ( analysis of covariance adjusting for treatment , country , baseline , age , and nerve-sparing score ) , responses to Sexual Encounter Profile ( SEP ) questions @-@ ( mixed models for repeated measures adjusting for treatment , country , visit , visit-treatment-interaction , age ) , and Standardized Morning Erection Question ( Cochran-Mantel-Haenszel test adjusted for age and country ) .


Four hundred twenty-three patients were randomized to tadalafil OaD ( N = @ ) , tadalafil PRN ( N = @ ) , and placebo ( N = @ ) .


Greater retainment of SPL was observed with tadalafil OaD vs placebo at the end of DBT ( least-square mean -LSB- @ % confidence interval -RSB- difference OaD vs placebo , @ mm -LSB- @ to @ mm -RSB- ; P = @ ) .


No significant effects on SPL were found for tadalafil PRN vs placebo , or for the nerve-sparing score .


Penile tumescence ( SEP@ ) and ability for vaginal insertion ( SEP@ ) significantly improved vs placebo at the end of double-blind and open-label treatment for patients randomized to tadalafil OaD only .


The ability for successful sexual intercourse ( SEP@ ) significantly improved with tadalafil OaD vs placebo only during DBT .


The distribution of Standardized Morning Erection Question responses was different at the end of DBT ( P = @ ) ; @ % of patients on tadalafil OaD , @ % on tadalafil PRN , and @ % on placebo reported absence of morning erections .


These data suggest the early initiation of tadalafil OaD protects from penile length loss and may contribute to protection from structural cavernosal changes after nsRP .


Efficacy and safety of first-line axitinib/paclitaxel/carboplatin versus bevacizumab/paclitaxel/carboplatin in advanced non-squamous non-small-cell lung cancer ( NSCLC ) was evaluated .


Patients with stage IIIB/IV disease stratified by adjuvant therapy and gender were randomised @ : @ to axitinib ( @ mg twice daily ) or bevacizumab -LSB- @ mg/kg every @ weeks ( Q@W ) -RSB- , both with paclitaxel ( @ mg/m ( @ ) Q@W ) / carboplatin ( AUC @ mg min/ml Q@W ) .


The trial was discontinued after preliminary analysis .


Median progression-free survival ( primary end point ) for axitinib ( N = @ ) and bevacizumab ( N = @ ) , respectively , was @ and @ months -LSB- hazard ratio ( HR ) @ , @ % confidence interval ( CI ) @-@ @ ; one-sided stratified P = @ -RSB- ; median overall survival was @ and @ months ( HR @ , @ % CI @-@ @ ; one-sided stratified P = @ ) .


Objective response rates ( @ % CI ) were @ % ( @-@ @ ) and @ % ( @-@ @ ) , respectively ; risk ratio @ ( @ % CI @-@ @ ; one-sided stratified P = @ ) .


The most common grade @/@ adverse events included neutropenia ( @ % versus @ % ) , fatigue ( @ % versus @ % ) , and hypertension ( @ % versus @ % ) .


Patient-reported outcomes based on the EORTC QLQ-C@ were similar between arms .


In patients with advanced non-squamous NSCLC , axitinib/paclitaxel/carboplatin did not improve efficacy versus bevacizumab/paclitaxel/carboplatin , and was less well tolerated .


To evaluate the effect of resistance training ( RT ) on non alcoholic liver disease ( NAFLD ) patients .


A randomized clinical trial enrolling NAFLD patients without secondary liver disease ( e.g. , without hepatitis B virus , hepatitis C virus or excessive alcohol consumption ) .


Patients were randomly allocated either to RT , three times weekly , for @ mo or a control arm consisting of home stretching .


The RT included leg press , chest press , seated rowing , latissimus pull down etc. with @-@ repetitions , @ sets for each exercise , for a total duration of @ min .


Hepatic ultrasound , fasting blood tests , anthropometrics and body composition by dual energy X-ray absorptiometry were assessed .


At baseline and follow-up , patients filled out a detailed semi-quantitative food frequency questionnaire reporting their habitual nutritional intake .


Steatosis was quantified by the hepatorenal-ultrasound index ( HRI ) representing the ratio between the brightness level of the liver and the right kidney .


The HRI has been previously demonstrated to be highly reproducible and was validated against liver biopsy and proton magnetic resonance spectroscopy .


Eighty two patients with primary NAFLD were randomized to receive @ mo of either RT or stretching .


After dropout or exclusion from analysis because of protocol violation ( weight change > @ kg ) , thirty three patients in the RT arm and @ in the stretching arm completed the study per protocol .


All baseline characteristics were similar for the two treatment groups with respect to demographics , anthropometrics and body composition , blood tests and liver steatosis on imaging .


HRI score was reduced significantly in the RT arm as compared to the stretching arm ( -@ @ vs -@ @ , P = @ ) .


The RT arm had a significantly higher reduction in total , trunk and android fat with increase in lean body mass .


There was no correlation between the reduction in HRI in the RT arm and weight change during the study , but it was positively correlated with the change in trunk fat ( r = @ , P = @ ) .


The RT arm had a significant reduction in serum ferritin and total cholesterol .


There was no significant difference between arms in dietary changes and these did not correlate with HRI change .


Three months RT improves hepatic fat content accompanied by favorable changes in body composition and ferritin .


RT may serve as a complement to treatment of NAFLD .


There are limited data on prognosis and outcomes of patients with new-onset atrial fibrillation ( AF ) compared with those with a prior history of AF .


We conducted a comparison of these @ groups in the AFFIRM trial .


New-onset AF was the qualifying arrhythmia in @,@ patients ( @ % ) .


Compared with patients with prior history of AF , patients with new-onset AF were more likely to have a history of heart failure .


There was no mortality difference between rate control ( RaC ) and rhythm control ( RhC ) among patients with new-onset AF ( @ % vs @ % , P = @ ) .


In the univariate model , new-onset AF was associated with increased risk of mortality compared with history of prior AF ( RaC unadjusted hazard ratio -LSB- HR -RSB- @ -LSB- P = @ -RSB- , RhC unadjusted HR @ -LSB- P = @ -RSB- ) .


However , after multivariate adjustments , new-onset AF did not carry an increased risk of mortality ( RaC adjusted HR @ -LSB- P = @ -RSB- , RhC adjusted HR @ -LSB- P = @ -RSB- ) .


Subjects with new-onset AF randomized to the RhC arm were more likely to remain in normal sinus rhythm at follow-up ( adjusted HR @ , P = @ ) compared with patients with prior history of AF .


In a multivariable analysis adjusting for confounders , new-onset AF was not associated with increased mortality compared with prior history of AF regardless of the treatment strategy .


Patients with new-onset AF treated with the rhythm control strategy were more likely to remain in normal sinus rhythm on follow-up .


Previous studies have shown a positive effect of zinc as an adjunctive therapy on reducing depressive symptoms .


However , to our knowledge , no study has examined the effect of zinc monotherapy on mood .


The aim of the present study was to determine the effects of zinc monotherapy on depressive symptoms and serum brain-derived neurotrophic factor ( BDNF ) levels in overweight or obese subjects .


Fifty overweight or obese subjects were randomly assigned into two groups and received either @ mg zinc or placebo daily for @ weeks .


At baseline and post-intervention , depression severity was assessed using Beck depression inventory II ( BDI II ) , and serum BDNF and zinc levels were determined by enzyme-linked immunosorbent assay and atomic absorption spectrophotometry , respectively .


The trial was completed with @ subjects .


After a @-week supplementation , serum zinc and BDNF levels increased significantly in the zinc-supplemented group compared with the placebo group .


BDI scores declined in both the groups at the end of the study , but reduction in the zinc-supplemented group was significantly higher than the placebo group .


More analysis revealed that following supplementation , BDI scores decreased in subgroup of subjects with depressive symptoms ( BDI @ ) ( n = @ ) , but did not change in the subgroup of non-depressed subjects ( BDI < @ ) ( n = @ ) .


Moreover , a significant inverse correlation was observed between serum BDNF levels and depression severity in all participants .


Interestingly , a significant positive correlation was found between serum BDNF and zinc levels at baseline .


Zinc monotherapy improves mood in overweight or obese subjects most likely through increasing BDNF levels .


Gastroparesis is a well-known complication to diabetes mellitus ( DM ) .


Dietary advice is considered to be of importance to reduce gastrointestinal ( GI ) symptoms in patients with diabetic gastroparesis , but no randomized controlled trials exist .


Our aim was to compare GI symptoms in insulin treated DM subjects with gastroparesis eating a diet with small particle size ( `` intervention diet '' ) with the recommended diet for DM ( `` control diet '' ) .


@ subjects with insulin treated DM and gastroparesis were randomized to the intervention diet or the control diet .


The patients received dietary advice by a dietitian at @ occasions during @ weeks .


GI symptom severity , nutrient intake and glycemic control were measured before and after the intervention .


A significantly greater reduction of the severity of the key gastroparetic symptoms-nausea/vomiting ( P = @ ) , postprandial fullness ( P = @ ) and bloating ( P = @ ) - were seen in patients who received the intervention diet compared with the control diet , and this was also true for regurgitation/heartburn ( P = @ ) , but not for abdominal pain .


Anxiety was reduced after the intervention diet , but not after the control diet , whereas no effect on depression or quality of life was noted in any of the groups .


A higher fat intake in the intervention group was noted , but otherwise no differences in body weight , HbA@c or nutrient intake were seen .


A small particle diet improves the key symptoms of gastroparesis in patients with diabetes mellitus .


( ClinicalTrials.gov NCT@ ) .


To evaluate if an opiate sparing multimodal regimen of dexamethasone , gabapentin , ibuprofen and paracetamol had better analgesic effect , less side effects and was safe compared to a traditional morphine and paracetamol regimen after cardiac surgery .


Open-label , prospective randomized controlled trial .


@ patients undergoing cardiac procedures through median sternotomy , were included in the period march @-August @ patients were available for analysis .


Pain was assessed with the @-numeric rating scale ( @-NRS ) .


Patients in the multimodal group demonstrated significantly lower average pain scores from the day of surgery throughout the third postoperative day .


Extensive nausea and vomiting , was found in no patient in the multimodal group but in @ patients in the morphine group , p < @ .


Postoperative rise in individual creatinine levels demonstrated a non-significant rise in the multimodal group , @ vs. @ , p = @ .


Patients in the multimodal group suffered less major in-hospital events in crude numbers : myocardial infarction ( MI ) ( @ vs. @ , p = @ ) , stroke ( @ vs. @ , p = @ ) , dialysis ( @ vs. @ , p = @ ) , and gastrointestinal ( GI ) bleeding ( @ vs. @ , p = @ ) .


@-day mortality was @ vs. @ , p = @ .


In patients undergoing cardiac surgery , a multimodal regimen offered significantly better analgesia than a traditional opiate regimen .


Nausea and vomiting complaints were significantly reduced .


No safety issues were observed with the multimodal regimen .


Antiretroviral drug regimen choice may influence changes in body composition .


The objective of this study was to compare changes in body composition between ritonavir-boosted atazanavir ( ATV/r ) and ritonavir-boosted lopinavir ( LPV/r ) over @ weeks using data from a substudy of CASTLE , which compared once-daily ATV/r with twice-daily LPV/r , both in combination with tenofovir disoproxil fumarate/emtricitabine in treatment-nave patients with HIV-@ infection .


We examined @ patients ( @ on ATV/r ; @ on LPV/r ) at baseline , @ and @ weeks using dual-energy X-ray absorptiometry and computerised tomography .


In the lowest baseline body mass index ( BMI ) group , there were significantly greater gains at week @ for ATV/r than for LPV/r in subcutaneous adipose tissue and in visceral adipose tissue ( VAT ) .


By week @ , patients with lowest baseline CD@ cell counts on ATV/r had @ % increases in VAT versus @ % reductions for patients receiving LPV/r .


Those with the lowest baseline BMI on ATV/r had @ % increases in VAT versus reductions of @ % for patients on LPV/r .


In the highest baseline BMI group , the mean increase in triglycerides was @ and @ % in the ATV/r and LPV/r arms , respectively .


Compared with baseline , an increase in proportion of patients with high waist circumference ( WC ) / high triglycerides at @ weeks was noted in both treatment arms , but this increase was numerically greater with LVP/r ( @ % ) than with ATV/r ( @ % ) .


Truncal fat gains on ATV/r primarily led to increases in WC , which may reflect return to health , while on LPV/r increases in WC and triglycerides occurred .


Changes in body composition with antiretroviral therapy are influenced by treatment choice and baseline characteristics .


To establish the cost-effectiveness of long-term humidification therapy ( LTHT ) added to usual care for patients with moderate or severe chronic obstructive pulmonary disease or bronchiectasis .


Resource usage in a @-month clinical trial of LTHT was estimated from hospital records , patient diaries , and the equipment supplier .


Health state utility values were derived from the St. Georges Respiratory Questionnaire ( SGRQ ) total score .


All patients who remained in the trial for @ months and who had at least @ days of diary records were included ( @ of @ ) .


Clinical costs were NZ $ @ ( @ % confidence interval -LSB- CI -RSB- $ @ - $ @ ) for the control group and NZ $ @ ( @ % CI $ @ - $ @ ) for the intervention group .


The mean health benefit per patient was -@ SGRQ units ( @ % CI -@ to -@ ; P < @ ) or +@ quality-adjusted life-years ( @ % CI @-@ @ ) .


With the intervention costing NZ $ @ annually , the mean cost per quality-adjusted life-year was NZ $ @,@ ( US $ @,@ ) and the bootstrap median was NZ $ @,@ ( @ th percentile - $ @,@ , @ th percentile $ @,@ ) .


At a willingness-to-pay ( WTP ) threshold of NZ $ @,@ , the probability of cost-effectiveness was @ % , ranging from @ % to @ % as the cost of LTHT was varied by @ % .


At a WTP of NZ $ @,@ , the probability was @ % ( range @ % -@ % ) .


LTHT is moderately cost-effective for patients with moderate to severe chronic obstructive pulmonary disease or bronchiectasis at a WTP threshold that is acceptable for public funding of medicines in New Zealand .


These findings must be interpreted with caution because of the modest size of the clinical study , necessary lack of blinding in the clinical trial , and uncertainty in estimating health state utility from the SQRQ .


To evaluate whether clinically relevant concentrations of stimulated C-peptide in response to a mixed-meal tolerance test can be detected after almost @ years of diabetes in people included in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications cohort .


Mixed-meal tolerance tests were performed in a sample of @ people .


C-peptide levels were measured using a chemiluminescent immunoassay .


This sample size assured a high probability of detecting C-peptide response if the true prevalence was at least @ % , a level that would justify the subsequent assessment of C-peptide in the entire cohort .


Of the @ participants , @ % showed a definite response , defined as one or more post-stimulus concentrations of C-peptide > @ nmol/l , and measurable concentrations were found in all participants .


These results show that a stimulated C-peptide response can be measured in some people with long-term Type @ diabetes .


Further investigation of all participants in the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications study will help relate long-term residual C-peptide response to glycaemia over time and provide insight into the relevance of this response in terms of insulin dose , severe hypoglycaemia , retinopathy , nephropathy and macrovascular disease .


Establishing the clinical relevance of long-term C-peptide responses is important in understanding the impact that therapy to preserve or improve - cell function may have in patients with long-term Type @ diabetes .


To clarify the effectiveness of Chinese herbal fomentation in treating chronic neck pain by means of changes in cervical kinematics .


Seventy-six patients with chronic neck pain were included in the study and were randomized into two groups based on the random number generator of the SPSS software : fomentation combined with Chinese herbal ( Group @ ) and fomentation without any medicine ( Group @ ) .


In both groups , the fomentation lasted for @ min and heated to @ C , once a day for @ consecutive days .


Standard lateral radiographs of the cervical spine were obtained including the neutral , full flexion , and full extension positions .


Before and after intervention , the following parameters were used to evaluate the changes in kinematics : range of motion ( ROM ) , sagittal alignment and instantaneous center of rotation ( ICR ) .


After treatment , the ROM was signifcantly higher than that of before treatment in Group @ ( @ , @ % CI : @-@ @ ; P < @ ) .


There was no significant difference between before and after treatment in Group @ ( P > @ ) .


Although C@-C@ cervical alignment was increased in both groups after treatment , no significant difference was detected between before and after treatment ( P > @ ) .


For Group @ , the significant X coordinate variation was only observed at C@/C@ level ( @ ; @ % CI : @ , @ ; P < @ ) .


There was a significant upward trend in the Y coordinate of the ICR at C@/C@ ( -@ ; @ % CI : -@ , -@ ; P < @ ) and C@/C@ after treatment ( -@ ; @ % CI : -@ , -@ ; P < @ ) .


For Group @ , the ICR location of each level was not statistically different between the pre - and post-treatment ( P > @ ) .


Chinese herbal fomentation could improve abnormal mobility in terms of ROM and ICR .


Chinese herbal fomentation might be an effective treatment for chronic neck pain .


Theoretically , salt supplementation should promote diuresis through increasing the glomerular filtration rate ( GFR ) during treatment of acute decompensated heart failure ( ADHF ) even with low-dose furosemide ; however , there is little evidence to support this idea .


This was a prospective , randomized , open-label , controlled trial that compared the diuretic effectiveness of salt infusion with that of glucose infusion supplemented with low-dose furosemide in @ consecutive patients with ADHF .


Patients were randomly administered @ % hypertonic saline solution supplemented with @ mg furosemide ( salt infusion group ) or glucose supplemented with @ mg furosemide ( glucose infusion group ) .


Our major end points were @-hour urinary volume and GFR .


Urinary volume was greater in the salt infusion group than in the glucose infusion group ( @,@ @ vs @,@ @ mL ; P < @ ) .


There was no significant difference in the estimated GFR at baseline .


Creatinine clearance for @ h was greater in the salt infusion group than in the glucose infusion group ( @ @ vs @ @ mL min ( -@ ) @ m ( -@ ) ; P = @ ) .


Salt supplementation rather than salt restriction evoked favorable diuresis through increasing GFR .


The findings support an efficacious novel approach of the treatment of ADHF .


To examine the efficacy and safety of adjunctive armodafinil for major depressive episodes associated with bipolar I disorder .


Adults meeting DSM-IV-TR criteria for bipolar I disorder and currently experiencing a major depressive episode while taking at least @ weeks of conventional maintenance medication were enrolled in a placebo-controlled evaluation of adjunctive armodafinil @ or @ mg ( conducted January @-March @ ) .


The primary efficacy measure was change from baseline to week @ on the @-item Inventory of Depressive Symptomatology-Clinician-Rated ( IDS-C@ ) total score in the @-mg armodafinil group versus placebo .


Of @ patients screened , @ were randomized ( placebo , n = @ ; armodafinil @ mg , n = @ ; armodafinil @ mg , n = @ ) .


The @-mg armodafinil group was discontinued by protocol amendment due to lower than expected patient enrollment .


For the @-mg armodafinil group versus placebo , there was a significantly greater decrease in least squares mean ( standard error of mean -LSB- SEM -RSB- ) IDS-C@ total score at week @ ( -@ -LSB- @ -RSB- vs -@ -LSB- @ -RSB- ; P = @ ; Cohen d therapeutic effect size = @ ) .


The proportion of IDS-C@ responders ( @ % decrease from baseline ) was significantly higher for the @-mg armodafinil group versus placebo at final visit ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- ; P = @ ) .


The proportion of IDS-C@ remitters ( total score @ ) was @ % ( @/@ ) for armodafinil @ mg versus @ % ( @/@ ) for placebo ( P = @ ) at final visit .


Adverse events ( AEs ) observed in > @ % of either the armodafinil @ mg or placebo groups and more frequently with @ mg armodafinil were diarrhea ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- ) , and nausea ( @ % -LSB- @/@ -RSB- vs @ % -LSB- @/@ -RSB- ) , respectively .


In the @-mg armodafinil group , there were @ serious AEs ( n = @ , hepatic failure leading to death ; n = @ , acute hepatitis ) .


The death was not considered related to study treatment .


Adjunctive armodafinil @ mg significantly improved symptoms of major depressive episodes associated with bipolar I disorder versus placebo and was generally well tolerated .


Despite the reported detrimental effects of international air travel on physical performance , a paucity of interventions have been scientifically tested and confirmed to benefit travelling athletes .


Consequently , the aim of the present study was to examine the effects of sleep hygiene and artificial bright light interventions on physical performance following simulated international travel .


In a randomized crossover design , @ physically active males completed @ h of simulated international travel with ( INT ) and without ( CON ) the interventions .


The mild hypoxia and cramped conditions typically encountered during commercial air travel were simulated in a normobaric , hypoxic room .


Physical performance , subjective jet-lag symptoms and mood states were assessed in the morning and evening on the day prior to and for two days post-travel .


Sleep quantity and quality were monitored throughout each trial .


Sleep duration was significantly reduced during travel in both trials ( P < @ ) , though total sleep duration during and following travel was almost significantly greater ( P = @ ) in INT ( @ ( @-@ @ ) h ) compared to CON ( @ ( @-@ @ ) h ) .


Maximal-sprint and countermovement jump ( P < @ ) , but not Yo-Yo Intermittent Recovery level @ test ( P > @ ) performance , were significantly reduced the evening of day @ and @ post-travel , with no differences between trials ( P > @ ) .


Furthermore , vigour was significantly greater ( P = @ ) the morning of day @ in INT -LSB- @ ( @-@ @ ) -RSB- compared to CON -LSB- @ ( @-@ @ ) -RSB- , and subjective jet-lag symptoms and mood states were significantly worse on day @ in CON only ( P < @ ) .


Whilst reducing travel-induced sleep disruption may attenuate travel fatigue , no improvements in the recovery of physical performance were apparent .


The purpose of this study was to determine if @-min walk test data assists in treatment decisions for patients withheart failure .


In the SCD-HeFT ( Sudden Cardiac Death in Heart Failure Trial ) , a pre-specified subgroup analysis showed that patients with New York Heart Association functional class III symptoms did not benefit from implantable cardioverter-defibrillator ( ICD ) therapy and appeared to be harmed by amiodarone , whereas New York Heart Association functional class II patients obtained significant survival benefit from ICD .


We postulated that a more objective measure of functional capacity , such as @-min walk ( @MW ) distance , might provide a better tool for selecting these preventive therapies .


A @MW test was performed before randomization in @,@ patients .


Median follow-up was @ months .


All-causemortality was the primary endpoint , with cause-specific mortality ( heart failure , arrhythmic ) examined insecondary analyses .


The hazard ratios ( HRs ) for ICD therapy compared to placebo were estimated within tertiles of baseline @MW distance : HR : @ ( @ % confidence interval -LSB- CI -RSB- : @ to @ ) for @MW distance > @ m ( top tertile ) ; HR : @ ( @ % CI : @ to @ ) for @MW distance @ to @ m ( middle tertile ) ; and HR : @ ( @ % CI : @ to @ ) for @MW distance < @ m ( bottom tertile ) .


The corresponding HRs for amiodarone compared to placebo were @ ( @ % CI : @ to @ ) for the top , @ ( @ % CI : @ to @ ) for the middle , and @ ( @ % CI : @ to @ ) for the bottom tertile .


The @MW distance was inversely related to heart failure-related mortality but not to arrhythmic mortality .


ICD therapy reduced arrhythmic mortality in the top @ tertiles of @MW , but had no effect on heart failure mortality .


A baseline @MW distance < @ m identified a subgroup of SCD-HeFT patients who were harmed by amiodarone therapy and did not benefit from ICD .


( Sudden Cardiac Death in Heart Failure Trial -LSB- SCD-HeFT -RSB- ; NCT@ ) .


Pre-diabetes and non-alcoholic fatty liver disease ( NAFLD ) are associated with an unhealthy lifestyle and pose extremely high costs to the healthcare system .


In this study , we aim to explore whether individualized aerobic exercise ( AEx ) and low carbohydrate diet ( LCh ) intervention affect hepatic fat content ( HFC ) in pre-diabetes via modification of gut microbiota composition and other post-interventional effects .


A @-month randomized intervention with @-month follow-up is conducted from January @ to December @ .


The target sample size for intervention is @ postmenopausal women and middle-aged men aged @-@year-old with pre-diabetes and NAFLD .


The qualified subjects are randomized into @ groups with @ subjects in each group : @ = AEx , @ = LCh , @ = AEx + LCh , and @ = control .


In addition , two age-matched reference groups ( @ = pre-diabetes without NAFLD ( n = @ ) and @ = Healthy without pre-diabetes or NAFLD ( n = @ ) ) are included .


The exercise program consists of progressive and variable aerobic exercise ( intensity of @ to @ % of initial fitness level , @-@ times/week and @-@min / time ) .


The diet program includes dietary consultation plus supplementation with a special lunch meal ( @ % of total energy intake/day ) which aims to reduce the amount of carbohydrate consumption ( @ % ) .


The control and reference groups are advised to maintain their habitual habits during the intervention .


The primary outcome measures are HFC , serum metabolomics and gut microbiota composition .


The secondary outcome measures include body composition and cytokines .


In addition , socio-psychological aspects , social support , physical activity and diet will be performed by means of questionnaire and interview .


Specific individualized exercise and diet intervention in this study offers a more efficient approach for liver fat reduction and diabetes prevention via modification of gut microbiota composition .


Besides , the study explores the importance of incorporating fitness assessment and exercise in the management of patients with pre-diabetes and fatty liver disorders .


If our program is shown to be effective , it will open new strategies to combat these chronic diseases .


Obesity and weight-loss are associated with methylation patterns in specific genes , but their effect on Long Interspersed Nuclear Elements ( LINE-@ ) methylation , a measure of global methylation is largely unknown .


Three hundred overweight/obese post-menopausal women ( @-@ years ) were part of a completed , @-year randomized controlled trial , comparing independent and combined effects of a reduced-calorie weight-loss diet , and exercise program , versus control .


DNA was extracted from peripheral blood leukocytes collected at baseline and @-months , and LINE-@ methylation analyzed by pyrosequencing .


Mean changes between groups using generalized estimating equations and examined effects of weight-loss on LINE-@ methylation using stratified analyses ( gained weight/no weight-loss -LSB- N = @ -RSB- ; < @ % -LSB- N = @ -RSB- ; @ % -@ % -LSB- N = @ -RSB- ; > @ % of baseline weight-loss -LSB- N = @ -RSB- ) within each arm , adjusted by blood cell counts were compared .


Associations between LINE-@ methylation and previously measured biomarkers , and anthropometrics were also examined .


No significant difference in LINE-@ methylation levels was detected in any intervention group versus controls .


The magnitude of weight-loss was not associated with LINE-@ methylation at @-months .


There were no associations between baseline characteristics of participants , or previously measured biomarkers , and LINE-@ methylation .


Our results suggest that lifestyle changes sufficient to significantly reduce weight over @-months may not change LINE-@ DNA methylation levels .


To compare contrast doses and acquisition times for late gadolinium enhancement ( LGE ) imaging at @ T using gadobenate dimeglumine ( Gd-BOPTA ) in patients with chronic myocardial infarction .


Thirty-four patients with chronic myocardial infarction were randomised to @ , @ and @ mmol/kg of Gd-BOPTA .


T@-weighted inversion recovery gradient echo sequences were performed at @ , @ , @ and @ min post-administration of contrast in a @-T scanner .


Scar-to-myocardium contrast-to-noise ratio ( CNR ) , scar-to-blood CNR , scar size and image quality were assessed .


Imaging at @ min was associated with a lower scar-to-blood CNR in comparison to @ , @ and @ min at @ mmol/kg , and in comparison to @ and @ min at @ mmol/kg .


At @-mmol / kg , imaging at @ min yielded smaller infarct sizes in comparison to @ and @ min .


Finally , at @-mmol / kg , imaging at @ min was associated with poorer image quality in comparison to later times .


In LGE imaging at @ T , low doses of Gd-BOPTA perform equally well as higher doses .


Early acquisition ( @ min ) is associated with lower infarct sizes and image quality .


Studies with sufficient diagnostic quality can be obtained after @ min using @ mmol/kg Gd-BOPTA .


Good performance of low Gd-BOPTA doses for LGE imaging at @ T. Imaging at @ min yields lower contrast , infarct sizes and image quality .


Diagnostic quality can be obtained after @ min using @-mmol / kg Gd-BOPTA .


Plant stanol esters lower serum low-density lipoprotein ( LDL ) - cholesterol ( LDL-C ) , but responses between individuals vary widely .


As the ability of subjects to respond to acute dietary challenges may reflect the flexibility to adapt to changes on the longer term , we related subjects ' acute postprandial metabolic changes to changes in serum lipoproteins after chronic intake of plant stanol esters .


In a double-blind crossover design , @ healthy subjects received in random order a high-fat shake enriched with or without plant stanol esters ( @ g ) .


Blood samples were taken during @ h to examine lipid , glucose and lipoprotein profiles .


Two subjects dropped out .


For the @ weeks after this postprandial test , the subjects who received the shake with plant stanol esters continued the consumption of plant stanol-enriched ( @g/day ) margarine and subjects receiving the control shake in the postprandial test consumed for the next @ weeks a control margarine .


After the washout period , subjects received the other shake and margarines .


The margarine enriched with plant stanol esters lowered concentrations of total cholesterol by @ % ( P < @ ) , LDL-C by @ % ( P < @ ) and apoB@ by @ % ( P < @ ) .


Furthermore , particle concentrations of total very low-density lipoprotein ( VLDL ) , small VLDL and large LDL were reduced by @ % ( P = @ ) , @ % ( P = @ ) and @ % ( P = @ ) , respectively .


Plant stanol esters did not affect parameters related to lipid and glucose metabolism during the postprandial phase .


However , the incremental area under the curve ( iAUC ) of the postprandial glucose concentration after consuming the control shake correlated positively with changes in fasting concentrations of total cholesterol , LDL-C , apoB@ , total VLDL , small VLDL and intermediate-density lipoprotein after @ weeks .


A single dose of plant stanol esters does not change postprandial lipid and lipoprotein profiles .


However , postprandial glucose responses may predict the effects of chronic plant stanol ester consumption .


This study sought to evaluate the diagnostic performance of multiparametric cardiovascular magnetic resonance ( CMR ) for detecting cardiac allograft vasculopathy ( CAV ) using contemporary invasive epicardial artery and microvascular assessment techniques as reference standards , and to compare the performance of CMR with that of angiography .


CAV continues to limit the long-term survival of heart transplant recipients .


Coronary angiography has a Class I recommendation for CAV surveillance and annual or biannual surveillance angiography is performed routinely inmost centers .


All transplant recipients referred for surveillance angiography at a single UK center over a @-year period were prospectively screened for study eligibility .


Patients prospectively underwent coronary angiography followed by coronary intravascular ultrasound , fractional flow reserve , and index of microcirculatory resistance .


Within @ month , patients underwent multiparametric CMR , including assessment of regional and global ventricular function , absolute myocardial blood flow quantification , and myocardial tissue characterization .


In addition , @ healthy volunteers underwent CMR .


Forty-eight patients were recruited , median @ years ( interquartile range : @ to @ years ) since transplantation .


The CMR myocardial perfusion reserve was the only independent predictor of both epicardial ( = -@ , p < @ ) and microvascular disease ( = -@ , p < @ ) on stepwise multivariable regression .


The CMRmyocardial perfusion reserve significantly outperformed angiography for detecting moderate CAV ( area underthe curve , @ -LSB- @ % confidence interval ( CI ) : @ to @ -RSB- vs. @ -LSB- @ % CI : @ to @ -RSB- , p = @ ) and severe CAV ( area under the curve , @ -LSB- @ % CI : @ to @ -RSB- vs. @ -LSB- @ % CI : @ to @ -RSB- , p = @ ) .


CAV , including epicardial and microvascular components , can be detected more accurately using noninvasive CMR-based absolute myocardial blood flow assessment than with invasive coronary angiography , the current clinical surveillance technique .


Acute lower respiratory infections ( ALRI ) are a leading cause of death among children .


Low birthweight is prevalent in South Asia and associated with increased risks of mortality , and morbidity , high levels of indoor household air pollution caused by open burning of biomass fuels are common and associated with high rates of ALRI and low birthweight .


Alternative stove designs that burn biomass fuel more efficiently have been proposed as one method for reducing these high exposures and lowering rates of these disorders .


We designed two randomized trials to test this hypothesis .


We conducted a pair of community-based , randomized trials of alternative cookstove installation in a rural district in southern Nepal .


Phase one was a cluster randomized , modified step-wedge design using an alternative biomass stove with a chimney .


A pre-installation period of morbidity assessment and household environmental assessment was conducted for six months in all households .


This was followed by a one year step-wedge phase with @ monthly steps for clusters of households to receive the alternative stove .


The timing of alternative stove introduction was randomized .


This step-wedge phase was followed in all households by another six month follow-up phase .


Eligibility criteria for phase one included household informed consent , the presence of a married woman of reproductive age ( @-@ yrs ) or a child < @ months .


Children were followed until @ months of age or the end of the trial .


Pregnancies were identified and followed until completion or end of the trial .


Phase two was an individually randomized trial of the same alternative biomass stove versus liquid propane gas stove in a subset of households that participated in phase one .


Follow-up for phase two was @ months following stove installation .


Eligibility criteria included the same components as phase one except children were only enrolled for morbidity follow-up if they were less than @ months.The primary outcomes included : incidence of ALRI in children and birthweight .


We presented the design and methods of two randomized trials of alternative cookstoves on rates of ALRI and birthweight .


Patients with atrial fibrillation ( AF ) are at significantly increased risk of stroke .


Oral anticoagulants ( OACs ) substantially reduce this risk , with gains seen across the spectrum of baseline risk .


Despite the benefit to patients , OAC prescribing remains suboptimal in the United Kingdom ( UK ) .


We will investigate whether an automated software system , operating within primary care electronic medical records , can improve the management of AF by identifying patients eligible for OAC therapy and increasing uptake of this treatment .


We will conduct a cluster randomised controlled trial , involving general practices using the Egton Medical Information Systems ( EMIS ) Web clinical system .


We will randomise practices to use an electronic software tool or to continue with usual care .


The tool will a ) produce ( and continually refresh ) a list of patients with AF who are eligible for OAC therapy -- practices will invite these patients to discuss therapy at the start of the trial -- and b ) generate electronic screen reminders in the medical records of those eligible , appearing throughout the trial .


The software will run for @ months in @ intervention practices .


A total of @ control practices will manage their AF register in line with the usual care offered .


The primary outcome is change in proportion of eligible patients with AF who have been prescribed OAC therapy after six months .


Secondary outcomes are incidence of stroke , transient ischaemic attack , other major thromboembolism , major haemorrhage and reports of inappropriate OAC prescribing in the data collection sample -- those deemed eligible for OACs .


We will conduct a process evaluation in parallel with the randomised trial .


We will use qualitative methods to examine patient and practitioner views of the intervention and its impact on primary care practice , including its time implications .


AURAS-AF will investigate whether a simple intervention , using electronic primary care records , can improve OAC uptake in a high risk group for stroke .


Given previous concerns about safety , especially surrounding inappropriate prescribing , we will also examine whether electronic reminders safely impact care in this clinical area .


The novel isoxazoline molecule fluralaner provides @weeks activity against fleas and @ to @weeks against tick infestations according to label claims .


This blinded , multi-center study in client-owned dogs evaluated the flea control provided by a single oral fluralaner treatment ( @-@mg / kg ; Bravecto , Merck Animal Health ) compared to a control group administered three oral spinosad ( @ - @mg/kg ; Comfortis , Elanco ) treatments at @-week intervals together with an amitraz collar ( @ % , Preventic , Virbac ) .


Households were randomized ( @:@ ratio ) to either fluralaner ( @ dogs , @ households ) or control ( @ dogs , @ households ) .


Within households , one primary dog with at least @ live fleas at enrollment was randomly selected for whole body flea counts every @weeks through Week @ ; all dogs were followed for safety until Week @ .


Fluralaner dogs received two additional doses at Weeks @ and @ for further safety and palatability observations through Week @ .


Geometric mean flea count reductions from baseline for the fluralaner group at Weeks @ , @ , and @ were @ % , @ % , and @ % , respectively ; and @ % , @ % , and @ % for the spinosad controls .


Percentages of flea-free primary dogs at Weeks @ , @ , and @ were @ % , @ % , and @ % for the fluralaner group ; and @ % , @ % , and @ % for the controls ; the differences were significant at Weeks @ ( P < @ ) and @ ( P = @ ) .


Improvements in veterinarian assessed flea allergy dermatitis ( FAD ) were observed in both groups .


Fluralaner tablets were accepted free choice in over @ % of doses .


The most common adverse event was vomiting , occurring in @ % of the fluralaner group and @ % of the controls .


No treatment related serious adverse events were reported .


A single treatment of dogs with the palatable fluralaner flavored chewable tablet provides a safe and effective option for @weeks of flea control at least equivalent to that of @ sequential treatments with spinosad tablets .


Linked to the high level of flea control was a substantial alleviation of associated signs of FAD .


Asparaginase and steroids can cause hypertriglyceridaemia in children with acute lymphoblastic leukaemia ( ALL ) .


There are no guidelines for screening or management of patients with severe hypertriglyceridaemia ( > @mg/dL ) during ALL therapy .


Fasting lipid profiles were obtained prospectively at four time-points for @ children consecutively enrolled on a frontline ALL study .


Risk factors were evaluated by the exact chi-square test .


Details of adverse events and management of hypertriglyceridaemia were extracted retrospectively .


Eighteen of @ ( @ % ) patients developed severe hypertriglyceridaemia .


Older age and treatment with higher doses of asparaginase and steroids on the standard/high-risk arm were significant risk factors .


Severe hypertriglyceridaemia was not associated with pancreatitis after adjustment for age and treatment arm or with osteonecrosis after adjustment for age .


However , patients with severe hypertriglyceridaemia had a @-@ times higher risk of thrombosis compared to patients without , albeit the difference was not statistically significant .


Of the @ episodes of severe hypertriglyceridaemia in @ patients , seven were managed conservatively while the others with pharmacotherapy .


Seventeen of @ patients continued to receive asparaginase and steroids .


Triglyceride levels normalised after completion of ALL therapy in all @ patients with available measurements .


Asparaginase - and steroid-induced transient hypertriglyceridaemia can be adequately managed with dietary modifications and close monitoring without altering chemotherapy .


Patients with severe hypertriglyceridaemia were not at increased risk of adverse events , with a possible exception of thrombosis .


The benefit of pharmacotherapy in decreasing symptoms and potential complications requires further investigation .


We examined electronic cigarette ( EC ) use , correlates of use , and associated changes in smoking behavior among smokers with serious mental illness in a clinical trial .


Adult smokers were recruited during acute psychiatric hospitalization ( N = @ , @ % enrollment among approached smokers ) in the San Francisco Bay Area between @-@ .


At baseline , participants averaged @ ( SD = @ ) cigarettes per day for @ ( SD = @ ) years ; @ % intended to quit smoking in the next month .


Analyses examined frequency and correlates of EC use reported over the @-month trial and changes in smoking behavior by EC use status .


EC use was @ % overall , and by year of enrollment , increased from @ % in @ to @ % in @ .


In multiple logistic regression , the likelihood of EC use was significantly greater with each additional year of recruitment , for those aged @-@ , and for those in the preparation versus precontemplation stage of change , and unlikely among Hispanic participants .


EC use was unrelated to gender , psychiatric diagnosis , and measures of tobacco dependence at baseline .


Further , over the @-month trial , EC use was not associated with changes in smoking status or , among continued smokers , with reductions in cigarettes per day .


Within a clinical trial with smokers with serious mental illness , EC use increased over time , particularly among younger adults and those intending to quit tobacco .


EC use was unrelated to changes in smoking .


The findings are of clinical interest and warrant further study .


We hypothesized that showing native Spanish speaking parents , a Spanish video explaining the risks and benefits of anesthesia within two weeks prior to surgery would reduce parental anxiety .


Subjects were randomly assigned to video-group or non-video-group .


Both groups completed PPUS , STAIT and APAIS tests before and after viewing the videos .


Parents repeated the same three tests before the operation on the day of the surgery .


The results revealed a decrease in @ points on the APAIS assessment in the non-video-group compared to @ points decrease in the video-group .


PPUS assessment revealed an average @ points increase in the non-video-group compared to @ points decrease in video-group .


Due to the extremely low sample size , the statistical significance of the findings can not be verified by statistical methods .


Hispanic parents who viewed the preanesthesia Spanish-video had lower levels of anxiety compared to those who did not watch the video .


The aim of this study was to examine the influence of aftercare sessions in a psychosomatic rehabilitation on the sociomedical development .


The after care group was compared with treatment as usual .


In a prospective , controlled and randomized longitudinal study data about the state of health and job status were assessed at @ measured time points .


As an indicator of the sociomedical development the current employment status was used .


Aftercare treatment ( n = @ ) included @-@ interview contacts ( via telephone or face-to-face ) within the first @ months after discharge from inpatient psychosomatic rehabilitation .


A control group ( n = @ ) received treatment as usual .


@ and @ months after the end of rehabilitation participants in the aftercare showed a better sociomedical development than the participants in the control condition .


To determine the effectiveness of helmet therapy for positional skull deformation compared with the natural course of the condition in infants aged @-@ months .


Pragmatic , single blinded , randomised controlled trial ( HEADS , HElmet therapy Assessment in Deformed Skulls ) nested in a prospective cohort study .


@ paediatric physiotherapy practices ; helmet therapy was administered at four specialised centres .


@ infants aged @ to @ months with moderate to severe skull deformation , who were born after @ weeks of gestation and had no muscular torticollis , craniosynostosis , or dysmorphic features .


Participants were randomly assigned to helmet therapy ( n = @ ) or to natural course of the condition ( n = @ ) according to a randomisation plan with blocks of eight .


Six months of helmet therapy compared with the natural course of skull deformation .


In both trial arms parents were asked to avoid any ( additional ) treatment for the skull deformation .


The primary outcome was change in skull shape from baseline to @ months of age assessed using plagiocephalometry ( anthropometric measurement instrument ) .


Change scores for plagiocephaly ( oblique diameter difference index ) and brachycephaly ( cranioproportional index ) were each included in an analysis of covariance , using baseline values as the covariate .


Secondary outcomes were ear deviation , facial asymmetry , occipital lift , and motor development in the infant , quality of life ( infant and parent measures ) , and parental satisfaction and anxiety .


Baseline measurements were performed in infants aged between @ and @ months , with follow-up measurements at @ , @ , and @ months .


Primary outcome assessment at @ months was blinded .


The change score for both plagiocephaly and brachycephaly was equal between the helmet therapy and natural course groups , with a mean difference of -@ ( @ % confidence interval -@ to @ , P = @ ) and @ ( -@ to @ , P = @ ) , respectively .


Full recovery was achieved in @ of @ ( @ % ) participants in the helmet therapy group and @ of @ ( @ % ) participants in the natural course group ( odds ratio @ , @ % confidence interval @ to @ , P = @ ) .


All parents reported one or more side effects .


Based on the equal effectiveness of helmet therapy and skull deformation following its natural course , high prevalence of side effects , and high costs associated with helmet therapy , we discourage the use of a helmet as a standard treatment for healthy infants with moderate to severe skull deformation .


PAD is a disabling , chronic condition of the lower extremities that affects approximately @ million people in the United States .


The purpose of this study was to determine whether an innovative home-based walking exercise program for patients with peripheral artery disease ( PAD ) improves self-efficacy for walking , desire for physical competence , satisfaction for physical functioning , social functioning , and acceptance of PAD related pain and discomfort .


The design was a @-month randomized controlled clinical trial of @ patients with PAD .


Participants were randomized to @ of @ parallel groups : a home-based group-mediated cognitive behavioral walking intervention or an attention control condition .


Of the @ participants randomized , @ completed the baseline and @-month follow-up visit .


The mean age was @ ( @ ) and was equally represented by men and women .


Close to half of the cohort was African American .


Following @-months of treatment , the intervention group experienced greater improvement on self-efficacy ( p = @ ) , satisfaction with functioning ( p = @ ) , pain acceptance ( p = @ ) , and social functioning ( p = @ ) than the control group ; the effects were consistent across a number of potential moderating variables .


Change in these outcomes was essentially independent of change in @-minute walk performance .


To test whether altered radiation fractionation schemes ( hyperfractionation -LSB- HFX -RSB- , accelerated fractionation , continuous -LSB- AFX-C -RSB- , and accelerated fractionation with split -LSB- AFX-S -RSB- ) improved local-regional control ( LRC ) rates for patients with squamous cell cancers ( SCC ) of the head and neck when compared with standard fractionation ( SFX ) of @ Gy .


Patients with stage III or IV ( or stage II base of tongue ) SCC ( n = @ ) were randomized to @ treatment arms : ( @ ) SFX , @ Gy/@ daily fractions/@ weeks ; ( @ ) HFX , @ Gy/@ twice-daily fractions/@ weeks ; ( @ ) AFX-S , @ Gy/@ fractions/@ weeks with a @-week rest after @ Gy ; and ( @ ) AFX-C , @ Gy/@ fractions/@ weeks .


The @ experimental arms were to be compared with SFX .


With patients censored for LRC at @ years , only the comparison of HFX with SFX was significantly different : HFX , hazard ratio ( HR ) @ ( @ % confidence interval @-@ @ ) , P = @ ; AFX-C , @ ( @ % confidence interval @-@ @ ) , P = @ .


With patients censored at @ years , HFX improved overall survival ( HR @ , P = @ ) .


Prevalence of any grade @ , @ , or @ toxicity at @ years ; any feeding tube use after @ days ; or feeding tube use at @ year did not differ significantly when the experimental arms were compared with SFX .


When @-week treatments were compared with @-week treatments , accelerated fractionation appeared to increase grade @ , @ or @ toxicity at @ years ( P = @ ) .


When the worst toxicity per patient was considered by treatment only , the AFX-C arm seemed to trend worse than the SFX arm when grade @-@ was compared with grade @-@ toxicity ( P = @ ) .


At @ years , only HFX improved LRC and overall survival for patients with locally advanced SCC without increasing late toxicity .


To identify the metabolic determinants of type @ diabetes non-remission status after bariatric surgery at @ and @ months .


A total of @ adults -LSB- mean sd body mass index @ @ kg/m ( @ ) , age @ @ years , glycated haemoglobin ( HbA@c ) @ @ % ) undergoing bariatric surgery -LSB- Roux-en-Y gastric bypass ( RYGB ) or sleeve gastrectomy ( SG ) -RSB- were enrolled in the present study , the Surgical Treatment and Medication Potentially Eradicate Diabetes Efficiently ( STAMPEDE ) trial .


Type @ diabetes remission was defined as HbA@c < @ % and fasting glucose < @ mg/dl ( i.e. < @ mmol/l ) without antidiabetic medication .


Indices of insulin secretion and sensitivity were calculated from plasma glucose , insulin and C-peptide values during a @-min mixed-meal tolerance test .


Body fat , incretins ( glucagon-like polypeptide-@ , gastric inhibitory peptide , ghrelin ) and adipokines -LSB- adiponectin , leptin , tumour necrosis factor - , high-sensitivity C-reactive protein ( hs-CRP ) -RSB- were also assessed .


At @ months , @ patients had available follow-up data ( RYGB , n = @ ; SG , n = @ ) .


Bariatric surgery induced type @ diabetes remission rates of @ and @ % at @ and @ months , respectively .


Total fat/abdominal fat loss , insulin secretion , insulin sensitivity and - cell function ( C-peptide@-@ / glucose@-@ Matsuda index ) improved more in those with remission at @ and @ months than in those without remission .


Incretin levels were unrelated to type @ diabetes remission , but , compared with those without remission , hs-CRP decreased and adiponectin increased more in those with remission .


Only baseline adiponectin level predicted lower HbA@c levels at @ and @ months , and elevated adiponectin correlated with enhanced - cell function , lower triglyceride levels and fat loss .


Smaller rises in adiponectin level , a mediator of insulin action and adipose mass , characterize type @ diabetes non-remission up to @ years after bariatric surgery .


Adjunctive strategies promoting greater fat loss and/or raising adiponectin may be key to achieving higher type @ diabetes remission rates after bariatric surgery .


To evaluate and compare novel robotic guidance and manual approaches based on procedural accuracy , procedural time , procedural performance , image quality as well as patient dose during image-guided microwave thermoablation .


The study was prospectively performed between June @ and December @ using @ patients .


Forty randomly selected patients ( group@ ) were treated with manual guidance and @ patients ( group@ ) were treated using a novel robotic guidance .


Parameters evaluated were procedural accuracy , total procedural time , procedural performance , quantitative/qualitative image quality and patient dose .


Two-sided Student 's t test and Wilcoxon rank-sum test were used to test the significance of the data and p values less than @ were considered statistically significant .


Accuracy parameters were significantly higher in group@ ( all p < @ ) .


Total procedural time showed a mean time difference of @min ( group@ > group@ ; p = @ ) .


Volume CT dose index and dose-length product were significantly lower for group@ compared to group@ ( all p < @ ) for CT fluoroscopy imaging .


Total procedural performance score was higher for group@ compared to group@ ( p = @ ) .


Image quality parameters were insignificant between examined groups .


The novel robotic guided approach improved the accuracy of targeting the target tumour , reduced patient dose and increased procedural performance ( which influences the procedural safety ) during ablation .


Few reports are available in the literature regarding robotic-assisted liver microwave ablation .


The robotic guided approach improved accuracy of localizing the target tumour .


Radiation dose on patients was reduced with the robotic guidance .


Numbers of insertions and readjustments were reduced , lowering chances of complications .


The relationships between pain , stress and anxiety , and their effect on burn wound re-epithelialization have not been well explored to-date .


The aim of this study was to investigate the effect of the Ditto ( a hand-held electronic medical device providing procedural preparation and distraction ) intervention on re-epithelialization rates in acute pediatric burns .


From August @ to August @ , children ( @-@ years ) with an acute burn presenting to the Royal Children 's Hospital , Brisbane , Australia fulfilled the study requirements and were randomized to -LSB- @ -RSB- Ditto intervention or -LSB- @ -RSB- standard practice .


Burn re-epithelialization , pain intensity , anxiety and stress measures were obtained at every dressing change until complete wound re-epithelialization .


One hundred and seventeen children were randomized and @ children were analyzed ( n = @ standard group ; n = @ Ditto group ) .


Inability to predict wound management resulted in @ participants no longer meeting the eligibility criteria .


Wounds in the Ditto intervention group re-epithelialized faster than the standard practice group ( -@ days ( CI : -@ to @ ) , p-value = @ ) , and significantly faster when analyses were adjusted for mean burn depth ( -@ days ( CI : -@ to -@ ) , p-value = @ ) .


Following procedural preparation at the first change of dressing , the Ditto group reported lower pain intensity scores ( -@ ( CI : -@ , @ ) p = @ ) and lower anxiety ratings ( -@ ( CI : -@ , @ ) p = @ ) .


At the second and third dressing removals average pain ( FPS-R and FLACC ) and anxiety scores ( VAS-A ) were at least one point lower when Ditto intervention was received .


The Ditto procedural preparation and distraction device is a useful tool alongside pharmacological intervention to improve the rate of burn re-epithelialization and manage pain and anxiety during burn wound care procedures .


Rapid heart rate lowering may be attractive in acute ST-segment elevation myocardial infarction ( STEMI ) .