Adverse events were reported in 38.0 % of patients after MRCP and 68.1 % after ERCP .


Of the 55 patients who experienced a serious adverse event , 3 ( 1.2 % ) and 52 ( 20.5 % ) of the events were reported to be temporally associated with MRCP and ERCP , respectively .


The adverse events most frequently considered related to RG1068 were nausea , abdominal pain , and flushing ; most were mild .


Compared with images from MRCP , those from RG1068-stimulated MRCP are improved in many aspects and could aid in diagnosis and clinical decision making for patients with acute , acute recurrent , or chronic pancreatitis .


RG1068-enhanced MRCP might also better identify patients in need of therapeutic ERCP ( ClinicalTrials.gov , Number : NCT00660335 ) .


Stress , depression , and anxiety affect 15 % to 25 % of pregnant women .


However , substantial barriers to psychosocial assessment exist , resulting in less than 20 % of prenatal care providers assessing and treating mental health problems .


Moreover , pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider .


Identifying screening and assessment tools and procedures that are acceptable to both women and service providers , cost-effective , and clinically useful is needed .


The primary objective of this randomized , parallel-group , superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment ( e-screening ) compared to paper-based screening .


Secondary objectives are to compare the two modes of screening on : ( 1 ) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk ; ( 2 ) the level of disclosure of symptoms ; ( 3 ) the factors associated with feasibility , acceptability , and disclosure ; ( 4 ) the psychometric properties of the e-version of the assessment tools ; and ( 5 ) cost-effectiveness .


A sample of 542 women will be recruited from large , primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city .


Pregnant women are eligible to participate if they : ( 1 ) receive care at one of the recruitment sites ; ( 2 ) are able to speak/read English ; ( 3 ) are willing to be randomized to e-screening ; and ( 4 ) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment .


Allocation is by computer-generated randomization .


Women in the intervention group will complete an online psychosocial assessment on a computer tablet , while those in the control group will complete the same assessment in paper-based form .


All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment .


Research assistants conducting diagnostic interviews and physicians will be blinded .


A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention .


We hypothesize that mental health e-screening in primary care maternity settings and high-risk antenatal units will be as or more feasible , acceptable , and capable of detecting depression , anxiety , and psychosocial risk compared to paper-based screening .


ClinicalTrials.gov Identifier : NCT01899534 .


To determine the effects of bevacizumab on patient-reported outcomes ( PROs ; secondary end point ) in the AURELIA trial .


Patients with platinum-resistant ovarian cancer were randomly assigned to chemotherapy alone ( CT ) or with bevacizumab ( BEV-CT ) .


PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Ovarian Cancer Module 28 ( EORTC QLQ-OV28 ) and Functional Assessment of Cancer Therapy-Ovarian Cancer symptom index ( FOSI ) at baseline and every two or three cycles ( 8/9 weeks ) until disease progression .


The primary PRO hypothesis was that more patients receiving BEV-CT than CT would achieve at least a 15 % ( 15-point ) absolute improvement on the QLQ-OV28 abdominal/GI symptom subscale ( items 31-36 ) at week 8/9 .


Patients with missing week 8/9 questionnaires were included as unimproved .


Questionnaires from all assessments until disease progression were analyzed using mixed-model repeated-measures ( MMRM ) analysis .


Sensitivity analyses were used to determine the effects of differing assumptions and methods for missing data .


Baseline questionnaires were available from 89 % of 361 randomly assigned patients .


More BEV-CT than CT patients achieved a 15 % improvement in abdominal/GI symptoms at week 8/9 ( primary PRO end point , 21.9 % v 9.3 % ; difference , 12.7 % ; 95 % CI , 4.4 to 20.9 ; P = .002 ) .


MMRM analysis covering all time points also favored BEV-CT ( difference , 6.4 points ; 95 % CI , 1.3 to 11.6 ; P = .015 ) .


More BEV-CT than CT patients achieved 15 % improvement in FOSI at week 8/9 ( 12.2 % v 3.1 % ; difference , 9.0 % ; 95 % CI , 2.9 % to 15.2 % ; P = .003 ) .


Sensitivity analyses gave similar results and conclusions .


Bevacizumab increased the proportion of patients achieving a 15 % improvement in patient-reported abdominal/GI symptoms during chemotherapy for platinum-resistant ovarian cancer .


Breastfeeding is associated with significant positive health outcomes for mothers and infants .


However , despite recommendations from the World Health Organization , exclusive breastfeeding for six months is uncommon .


Increased breastfeeding support early in the postpartum period may be effective in improving breastfeeding maintenance .


This trial will evaluate two community-based interventions to increase breastfeeding duration in Local Government Areas ( LGAs ) in Victoria , Australia .


A three-arm cluster randomised controlled trial design will be used .


Victorian LGAs with a lower than average rate of any breastfeeding at discharge from hospital and more than 450 births per year that agree to participate will be randomly allocated to one of three trial arms : 1 ) standard care ; 2 ) home-based breastfeeding support ; or 3 ) home-based breastfeeding support plus access to a community-based breastfeeding drop-in centre .


The services provided in LGAs allocated to ` standard care ' are those routinely available to postpartum women .


LGAs allocated to the home-based visiting intervention will provide home-visits to women who are identified as at risk of breastfeeding cessation in the early postnatal period .


These visits will be provided by Maternal and Child Health Nurses who have received training to provide the intervention ( SILC-MCHNs ) .


In areas allocated to receive the second intervention , in addition to home-based breastfeeding support , community breastfeeding drop-in centres will be made available , staffed by a SILC-MCHN .


The interventions will run in LGAs for a nine to twelve month period depending on birth numbers .


The primary outcome is the proportion of infants receiving any breast milk at four months of age .


Breastfeeding outcomes will be obtained from routinely collected Maternal and Child Health centre data and from a new data item collecting infant feeding ` in the last 24 hours ' .


Information will also be obtained directly from women via a postal survey .


A comprehensive process evaluation will be conducted .


This study will determine if early home-based breastfeeding support by a health professional for women at risk of stopping breastfeeding , with or without access to a community-based breastfeeding drop-in centre , increases breastfeeding duration in Victorian LGAs with low breastfeeding rates .


Australian New Zealand Clinical Trials Registry : ACTRN12611000898954 .


Insulin-resistant states , including type 2 diabetes ( T2D ) and prediabetes , are associated with elevated cardiovascular ( CV ) risk .


Aleglitazar is a dual peroxisome proliferator-activated receptor / agonist with favorable insulin-sensitizing and glucose-lowering actions , favorable effects on blood lipids , and an acceptable safety profile in short-time studies .


Therefore , it was hypothesized that aleglitazar would reduce CV morbidity and mortality in patients with T2D mellitus and prediabetes ( defined as glycosylated hemoglobin 5.7 % to < 6.5 % ) with previous CV complications .


ALEPREVENT was a phase III , multicenter , randomized , double-blind , trial comparing aleglitazar 150 g or placebo daily in patients with T2D or prediabetes with established , stable CV disease .


The intended sample size was 19,000 with a primary efficacy measure of major adverse CV events .


However , the trial was halted prematurely after 1,999 patients had been randomized because of futility and an unfavorable benefit risk ratio in another CV outcomes trial evaluating aleglitazar .


At study termination after 58 38 days of treatment , data had been collected from 1,996 patients ( 1,581 with T2D and 415 with pre-T2D ) .


Despite the brief duration of treatment , aleglitazar induced favorable changes in glycosylated hemoglobin and blood lipids , similar for participants with T2D or prediabetes .


However , compared with placebo , aleglitazar increased the incidence of hypoglycemia ( 86 vs 166 ; P < .0001 ) , and muscular events ( 3 vs12 ; P = .012 ) .


Even within a short duration of exposure , aleglitazar was associated with excess adverse events , corroborating the findings of a larger and longer trial in T2D .


Coupled with the previous failure of several other peroxisome proliferator-activated receptor / activators , this class now holds little promise for CV therapeutics .


Monopolar electrosurgery is the gold standard for surgical preparation in thoracoscopic spine procedures .


However , use of ultrasound scissors could decrease blood loss , accelerate the preparation time and improve patient safety , while minimizing operative costs .


This trial compares both preparation techniques for ventral thoracoscopic spondylodesis .


The study design is an open , prospective , randomized , and double-blinded two-armed clinical trial performed in two centres .


Forty-one patients with vertebral body fractures from T10 to L2 were included .


Primary endpoint : preparation time .


Secondary endpoints : blood loss , organ injuries , duration of hospitalization .


Primary and secondary endpoints did not differ significantly between groups ( p level 0.05 ) .


Increased blood loss ( 150 ml or more ) was eliminated with ultrasound scissors ( p = 0.0014 ) .


Primary and secondary endpoints did not differ significantly between the two preparation techniques .


The use of either ultrasound scissors or electric scalpel offers safe and effective preparation for thoracoscopic spine surgery .


Delirium is frequently diagnosed in critically ill patients and is associated with poor clinical outcomes .


Haloperidol is the most commonly used drug for delirium despite little evidence of its effectiveness .


The aim of this study was to establish whether early treatment with haloperidol would decrease the time that survivors of critical illness spent in delirium or coma .


We did this double-blind , placebo-controlled randomised trial in a general adult intensive care unit ( ICU ) .


Critically ill patients ( 18 years ) needing mechanical ventilation within 72 h of admission were enrolled .


Patients were randomised ( by an independent nurse , in 1:1 ratio , with permuted block size of four and six , using a centralised , secure web-based randomisation service ) to receive haloperidol 2.5 mg or 0.9 % saline placebo intravenously every 8 h , irrespective of coma or delirium status .


Study drug was discontinued on ICU discharge , once delirium-free and coma-free for 2 consecutive days , or after a maximum of 14 days of treatment , whichever came first .


Delirium was assessed using the confusion assessment method for the ICU ( CAM-ICU ) .


The primary outcome was delirium-free and coma-free days , defined as the number of days in the first 14 days after randomisation during which the patient was alive without delirium and not in coma from any cause .


Patients who died within the 14 day study period were recorded as having 0 days free of delirium and coma .


ICU clinical and research staff and patients were masked to treatment throughout the study .


Analyses were by intention to treat .


This trial is registered with the International Standard Randomised Controlled Trial Registry , number ISRCTN83567338 .


142 patients were randomised , 141 were included in the final analysis ( 71 haloperidol , 70 placebo ) .


Patients in the haloperidol group spent about the same number of days alive , without delirium , and without coma as did patients in the placebo group ( median 5 days [ IQR 0-10 ] vs 6 days [ 0-11 ] days ; p = 0.53 ) .


The most common adverse events were oversedation ( 11 patients in the haloperidol group vs six in the placebo group ) and QTc prolongation ( seven patients in the haloperidol group vs six in the placebo group ) .


No patient had a serious adverse event related to the study drug .


These results do not support the hypothesis that haloperidol modifies duration of delirium in critically ill patients .


Although haloperidol can be used safely in this population of patients , pending the results of trials in progress , the use of intravenous haloperidol should be reserved for short-term management of acute agitation .


National Institute for Health Research .


A recently published study showed the safety and efficacy of LSD-assisted psychotherapy in patients with anxiety associated with life-threatening diseases .


Participants of this study were included in a prospective follow-up .


12 months after finishing LSD psychotherapy , 10 participants were tested for anxiety ( STAI ) and participated in a semi-structured interview .


A Qualitative Content Analysis ( QCA ) was carried out on the interviews to elaborate about LSD effects and lasting psychological changes .


None of the participants reported lasting adverse reactions .


The significant benefits as measured with the STAI were sustained over a 12-month period .


In the QCA participants consistently reported insightful , cathartic and interpersonal experiences , accompanied by a reduction in anxiety ( 77.8 % ) and a rise in quality of life ( 66.7 % ) .


Evaluations of subjective experiences suggest facilitated access to emotions , confrontation of previously unknown anxieties , worries , resources and intense emotional peak experiences la Maslow as major psychological working mechanisms .


The experiences created led to a restructuring of the person 's emotional trust , situational understanding , habits and world view .


LSD administered in a medically supervised psychotherapeutic setting can be safe and generate lasting benefits in patients with a life-threatening disease .


Explanatory models for the therapeutic effects of LSD warrant further study .


This study aimed to evaluate the effectiveness of a static ground reaction ankle foot orthosis and strapping system on improving gait parameters in children with spastic diplegic cerebral palsy .


The current study was conducted at the physical therapy faculty of Cairo University , Egypt .


This study included 57 children of both sexes , aged 6 to 8 years .


Three-armed randomized control trial .


Participants in all groups received a traditional neuro-developmental physical therapy program that included standing and gait training exercises .


Children in group A performed the training program without any orthotic management , in group B with the TheraTogs strapping system , and in group C with the TheraTogs strapping system and static ground reaction ankle foot orthoses .


Children underwent treatment for two hours daily , except on weekends , for twelve successive weeks .


Gait speed , cadence , stride length , and hip and knee flexion angles in the mid-stance phase were evaluated pre-and post-treatment using a three-dimensional motion analysis system ( pre-reflex system ) .


Statistically significant differences were recorded among the three groups post-treatment in gait speed , cadences , and stride length .


The P-values for these variable differences were 0.03 , 0.011 , and 0.001 respectively .


Significant post-treatment differences were also recorded for bilateral hip-and knee-flexion angles .


For all measured parameters , better significant results were registered for group C than for the other groups .


Orthotic intervention composed of a static ground reaction ankle foot orthosis combined with the TheraTogs strapping system improves gait more than conventional treatment with or without TheraTogs in children with spastic diplegic cerebral palsy .


To investigate if the cramp threshold frequency ( CTF ) can be altered by electrical muscle stimulation in a shortened position .


A total of 15 healthy male sport students were randomly allocated to an intervention ( IG , n = 10 ) and a non-treatment control group ( CG , n = 5 ) .


Calf muscles of both legs in the IG were stimulated equally twice a week over 6 weeks .


The protocol was 35 s on , 10 s off , 150 s impulse width , 30 Hz above the individual CTF , and was at 85 % of the maximal tolerated stimulation energy .


One leg was stimulated in a shortened position , inducing muscle cramps ( CT ) , while the opposite leg was fixated in a neutral position at the ankle , hindering muscle cramps ( nCT ) .


CTF tests were performed prior to the first and 96 h after the 6 ( th ) ( 3 w ) and 12 ( th ) ( 6 w ) training session .


After 3 w , the CTF had significantly ( p < 0.001 ) increased in CT calves from 23.35.7 Hz to 33.36.9 Hz , while it remained unchanged in nCT ( pre : 23.65.7 Hz , mid : 22.33.5 Hz ) and in both legs of the CG ( pre : 21.83.2 Hz , mid : 22.02.7 Hz ) .


Only CT saw further insignificant increases in the CTF .


The applied stimulation energy ( mA s ) positively correlated with the effect on the CTF ( r = 0.92 ; p < 0.001 ) .


The present study may be useful for developing new non-pharmacological strategies to reduce cramp susceptibility .


German Clinical Trials Register DRKS00005312 .


To determine the effects of addition of different dosages of gonadotrophin releasing hormone agonist ( GnRH-a ) to routine luteal phase support ( LPS ) on implantation and pregnancy rates .


Three hundred infertile couples who were treated by intracytoplasmic sperm injection and embryo transfer ( ICSI-ET ) following controlled ovarian stimulation ( COS ) with long luteal GnRH agonist protocol were enrolled .


All women received 600 mg/day vaginal micronized progesterone plus 4 mg 17 estradiol for LPS starting from the day of oocyte retrieval .


Patients ( n = 300 ) were randomized into three treatment groups .


Group A ( n = 100 ) received leuprolide acetate 1 mg s.c. injection 3 days after ET in addition to routine LPS .


Group B ( n = 100 ) received two sequential doses of leuprolide acetate 1 mg s.c. injections 3 and 6 days after ET in addition to routine LPS .


Control group ( n = 100 ) received only the routine LPS .


A total of 279 patients completed the study .


The groups were comparable in terms of baseline demographic parameters including age , duration of infertility and day 3 levels of FSH and estradiol .


The cycle parameters of the groups were also comparable regarding the E2 level on day of hCG , number of retrieved oocytes , number of day 3 embryos , number of embryos transferred , and endometrial thickness on both days of OPU and ET .


The implantation rates were similar in between the Groups A , B , and control group ( 20.7 % and 25.8 % vs. 13.3 % , respectively ; P = .099 ) .


The clinical pregnancy rates and miscarriage rates were similar in between the groups .


The ongoing pregnancy rates were 27.4 % in control group , 36 % in Group A and 42.9 % in Group B ( P = .093 ) .


The OHSS rates were comparable in between the groups .


The multiple pregnancy rates were significantly higher in Groups A and B than in control group ( 12 % and 17.9 % vs. 4.2 % , respectively ; P = .014 ) .


The implantation , clinical pregnancy and ongoing pregnancy and multiple pregnancy rates seem to be increased with the addition of GnRH-a to routine luteal phase support .


Obesity-induced chronic inflammation is a key component of the pathogenesis of insulin resistance .


Mounting evidence has demonstrated anti-inflammatory characteristics for vitamin D. Although analogues of vitamin D3 have extensively been used in the treatment of various chronic inflammatory diseases , to our knowledge , no such research is conducted in regards with obesity .


The aim of this double blind clinical trial study is to investigate whether alphacalcidol treatment in obese subjects can affect the cytokine profile and insulin resistance .


Moreover , we evaluated the pathways of vitamin D receptor ( VDR ) , PPAR and PGC1 gene expressions which may lead to insulin resistance following treatment with either alphacalcidol or placebo .


A total of 94 obese participants ( BMI30 ) were recruited for the current double blind clinical trial study .


Patients were divided into two intervention ( N. = 40 ) and control groups ( N. = 54 ) based on the stratified randomized method .


One-Alpha Capsules 1 microgram : alfacalcidol ( 1 - hydroxyvitamin D3 ) and placebo were given to subjects once a day for 8 weeks .


Analysis of body composition was performed with use of Body Composition Analyzer .


The circulating levels of TNF - , IL-1 , IL-4 , IL-6 , IL-10 , IL-13 , IL-17 , PTH , and 25-Hydroxy Vi-tamin D were measured with the use of EIA method .


The PBMCs were separated from whole blood by Ficoll-hypaque technique .


Total cellular RNA was extracted and the cDNA was synthesized .


The real-time PCR using specific primer pairs for VDR , PGC1 , PPAR , and - actin was performed .


The FPG , fat percent and PTH levels were decreased and the levels of HDL-cholesterol and 25-hydroxy vitamin D were significantly increased after treatment with Alfacalcidol .


Regarding to cytokines levels , the levels of IL6 were significantly decreased and IL10 were significantly increased in Alfacalcidol group in comparison with the control group .


The relative expressions of VDR , PGC1 , and PPAR genes significantly increased in Alfacalcidol group .


We found also significant positive correlation between circulating 25-OH vitamin D and relative PGC1 gene expression in participants with insulin resistance .


It seems that Alfacalcidol treatment may be effective in amelioration of the inflammatory state in obesity .


This supplement might also improve resistance to insulin through enhancement of relative VDR and its downstream genes expression , which are demonstrated to be involved in glucose homeostasis pathways .


Macrolides reduce exacerbations in patients with COPD .


Their effects on health status has not been assessed as primary outcome and is less clear .


This study assessed the effects of prophylactic azithromycin on cough-specific health status in COPD-patients with chronic productive cough .


In this randomised controlled trial 84 patients met the eligibility criteria : age of 40 years , COPD GOLD stage 2 and chronic productive cough .


The intervention-group ( n = 42 ) received azithromycin 250 mg 3 times a week and the control-group ( n = 42 ) received a placebo .


Primary outcome was cough-specific health status at 12 weeks , measured with the Leicester Cough Questionnaire ( LCQ ) .


Secondary outcomes included generic and COPD-specific health status and exacerbations .


Changes in adverse events and microbiology were monitored .


Mean age of participants was 6810 years and mean FEV1 was 1.360.47 L.


The improvement in LCQ total score at 12 weeks was significantly greater with azithromycin ( difference 1.30.5 , 95 % CI 0.3 ; 2.3 , p = 0.01 ) and met the minimal clinically important difference .


Similar results were found for the domain scores , and COPD-specific and generic health status questionnaires .


Other secondary endpoints were non-significant .


No imbalances in adverse events were found .


Prophylactic azithromycin improved cough-specific health status in COPD-patients with chronic productive cough to a clinically relevant degree .


ClinicalTrials.gov NCT01071161 .


High intake of cow-milk protein in formula-fed infants is associated with higher weight gain and increased adiposity , which have led to recommendations to limit protein intake in later infancy .


The impact of protein from meats for breastfed infants during complementary feeding may be different .


We examined the effect of protein from meat as complementary foods on growth and metabolic profiles of breastfed infants .


This was a secondary analysis from a trial in which exclusively breastfed infants ( 5-6 mo old from the Denver , CO , metro area ) were randomly assigned to receive commercially available pureed meats ( Meat group ; n = 14 ) or infant cereal ( Cereal group ; n = 28 ) as their primary complementary feedings for 5 mo. .


Anthropometric measures and diet records were collected monthly from 5 to 9 mo of age ; intakes from complementary feeding and breast milk were assessed at 9 mo of age .


The Meat group had significantly higher protein intake , whereas energy , carbohydrate , and fat intakes from complementary feeding did not differ by group over time .


At 9 mo of age , mean ( SEM ) intakes of total ( complementary feeding plus breast milk ) protein were 2.9 0.6 and 1.4 0.4 g kg ( -1 ) d ( -1 ) , 17 % and 9 % of daily energy intake , for Meat and Cereal groups , respectively ( P < 0.001 ) .


From 5 to 9 mo of age , the weight-for-age z score ( WAZ ) and length-for-age z score ( LAZ ) increased in the Meat group ( WAZ : 0.24 0.19 ; LAZ : 0.14 0.12 ) and decreased in the Cereal group ( WAZ : -0.07 0.17 ; LAZ : -0.27 0.24 ) ( P-group by time < 0.05 ) .


The change in weight-for-length z score did not differ between groups .


Total protein intake at 9 mo of age and baseline WAZ were important predictors of changes in the WAZ ( R ( 2 ) = 0.23 , P = 0.01 ) .


In breastfed infants , higher protein intake from meats was associated with greater linear growth and weight gain but without excessive gain in adiposity , suggesting that potential risks of high protein intake may differ between breastfed and formula-fed infants and by the source of protein .


We aimed to examine the association between total number of resected nodes and survival in patients after esophagectomy with and without nCRT .


Most studies concerning the potentially positive effect of extended lymphadenectomy on survival have been performed in patients who underwent surgery alone .


As nCRT is known to frequently `` sterilize '' regional nodes , it is unclear whether extended lymphadenectomy after nCRT is still useful .


Patients from the randomized CROSS-trial who completed the entire protocol ( ie , surgery alone or chemoradiotherapy + surgery ) were included .


With Cox regression models , we compared the impact of number of resected nodes as well as resected positive nodes on survival in both groups .


One hundred sixty-one patients underwent surgery alone , and 159 patients received multimodality treatment .


The median ( interquartile range ) number of resected nodes was 18 ( 12-27 ) and 14 ( 9-21 ) , with 2 ( 1-6 ) and 0 ( 0-1 ) resected positive nodes , respectively .


Persistent lymph node positivity after nCRT had a greater negative prognostic impact on survival as compared with lymph node positivity after surgery alone .


The total number of resected nodes was significantly associated with survival for patients in the surgery-alone arm ( hazard ratio per 10 additionally resected nodes , 0.76 ; P = 0.007 ) , but not in the multimodality arm ( hazard ratio 1.00 ; P = 0.98 ) .


The number of resected nodes had a prognostic impact on survival in patients after surgery alone , but its therapeutic value is still controversial .


After nCRT , the number of resected nodes was not associated with survival .


These data question the indication for maximization of lymphadenectomy after nCRT .


To examine the effects of foot reflexology massage on anxiety in patients following CABG surgery .


In this randomized controlled trial , 80 patients who met the inclusion criteria were conveniently sampled and randomly allocated to the experimental and control groups after they were matched on age and gender .


On the days following surgery , the experimental group received foot reflexology massage on their left foot 20mina day for 4 days , while the control group was given a gentle foot rub with oil for one minute .


Anxiety was measured using the short-form of the Spielberger State-Trait Anxiety Inventory and the Visual Analogue Scale-Anxiety .


Both measurement instruments confirmed a significant decrease in anxiety following the foot reflexology massage .


The significant decrease in anxiety in the experimental group following the foot reflexology massage supports the use of this complementary therapy technique for the relief of anxiety .


To estimate the effect of sequence on response precision and response behavior in health valuation studies .


Time trade-off ( TTO ) and paired comparison responses from six health valuation studies-four US , one Spanish , and one Dutch-were examined ( 22,225 respondents ) to test whether task sequence influences response precision ( e.g. , rounding ) , response changes , and median response times .


Each study used a computer-based instrument that randomized task sequence among a national sample of adults , age 18 years or older , from the general population .


For both TTO and paired comparisons , median response times decreased with sequence ( i.e. , learning ) , but tended to flatten after the first three tasks .


Although the paired comparison evidence demonstrated that sequence had no effect on response precision , the frequency of rounded TTO responses ( to either 1-year or 5-year units ) increased with sequence .


Based on these results , randomizing or reducing the number of paired comparison tasks does not appear to influence response precision ; however , generalizability , practicality , and precautionary considerations remain .


Overall , participants learned to respond efficiently within the first three tasks and did not resort to satisficing , but may have rounded their TTO responses .


Bulkamid is a new polyacrylamide hydrogel bulking agent for stress urinary incontinence that is injected in the urethral submucosa using a specifically designed device .


We evaluated the safety and efficacy of Bulkamid vs Contigen collagen gel for stress urinary incontinence or stress predominant mixed urinary incontinence .


This was a single-blind , randomized , prospective , 33-center , 2-arm parallel study of hydrogel vs collagen gel with followup to 1year .


At baseline patients underwent physical examination and bladder testing , and completed quality of life questionnaires and bladder diaries .


After randomization patients could receive up to 3 injections at 1-month intervals .


Patients were assessed 3 , 6 , 9 and 12 months after bulking .


They completed bladder diaries and quality of life questionnaires , and pad weight was tested .


Atthe last visit Valsalva leak point pressure was measured .


Subjective and objective incontinence outcomes and adverse events were compared .


Of the 345 women 229 were randomized to hydrogel and 116 were randomized to collagen gel .


At 12 months a 50 % or greater decrease in leakage and incontinence episodes was seen in 53.2 % and 55.4 % of patients who received hydrogel and collagen gel , respectively .


At 12 months 47.2 % of patients with hydrogel and 50 % with collagen gel reported zero stress incontinence episodes , and 77.1 % and 70 % , respectively , considered themselves cured or improved .


Major adverse events were rare in each group .


Bulkamid is not inferior to Contigen .


It has a favorable , persistent effect on stress urinary incontinence with a low risk of serious adverse events .


Bulkamid is a new , simple , office based bulking system that shows promise asatreatment in women with stress urinary incontinence , particularly since Contigen is no longer commercially available .


Most problematic alcohol users never seek professional help to reduce their use , and Web-based interventions might fulfill users ' unmet needs for professional support .


This randomized controlled trial compared two open Web-based interventions , one extended self-help program and one brief screening and feedback intervention , with an assessment-only control group .


Participants were 633 Internet help seekers with at least hazardous alcohol use ( Alcohol Use Disorders Identification Test , AUDIT 6 for women and 8 for men ) .


All groups reduced their alcohol use at 3-month follow-up ( p < 0.001 ) , remaining stable at the 6 - and 12-month follow-ups ( n.s. ) according to AUDIT-C and AUDIT scores ( intention-to-treat , ITT , analysis ) .


Per protocol ( PP ) analysis , including only participants who accessed the interventions and also reported accessing additional outside interventions during the trial , showed that about 75 % of extended self-help participants moved from probable dependence , harmful or hazardous use to lower alcohol use levels at 3 - and 6 - and 12-month follow-ups , compared to about 40-60 % of brief intervention users and controls who accessed extra help ( p < 0.05 ) .


ITT analysis suggested parity over time for all interventions , including assessment only , in reducing problematic alcohol use .


In contrast , PP analysis suggested that cognitive-behavioral extended self-help in combination with other interventions was more effective in changing alcohol use than brief intervention or assessment only .


To compare the difference in the efficacy on cervical type of cervical spondylosis ( CS ) between the combined treatment of sword-like needle and chiropractic spinal manipulation ( the combined therapy ) and the simple chiropractic spinal manipulation .


One hundred and thirty-eight cases of cervical type of CS were randomized into a combined therapy group ( 76 cases ) and a simple chiropractic spinal manipulation group ( 62 cases ) .


In the combined therapy group , the sword-like needle therapy was applied at Fengchi ( GB 20 ) , Tianzhu ( BL 10 ) and Jiaji ( EX-B 2 ) C3-C5 .


The chiropractic spinal manipulation was used in combination .


In the chiropractic spinal manipulation group , the simple chiropractic spinal manipulation was adopted .


The treatment was given once every other day in the two groups , 10 days made one session .


One session of treatment was required .


Visual analog scale ( VAS ) score was observed before and after treatment in the two groups and the efficacies were compared between the two groups .


VAS score after treatment was reduced obviously as compared with that before treatment in the patients of the two groups ( both P < 0.01 ) and VAS score after treatment in the combined therapy group was lower than that in the simple chiropractic spinal manipulation group ( 1.50 + / - 0.58 vs 1.87 + / -1.05 , P < 0.01 ) .


In the combined therapy group , 48 cases were cured , 20 cases remarkably effective , 8 cases improved and 0 case failed .


In the chiropractic spinal manipulation group , 30 cases were cured , 16 cases remarkably effective , 15 cases improved and 1 case failed .


The overall efficacy in the combined therapy group was better than that in the chiropractic spinal manipulation ( P < 0.05 ) .


The sword-like needle therapy combined with chiropractic spinal manipulation relieve effectively pain in cervical type of CS and the efficacy is superior to the simple chiropractic spinal manipulation .


Recently it has been reported a benefit effect with the use of metformin in patients with malignant disease .


Our objective was to evaluate the effect of adding metformin to chemotherapy regimen over the percentage of early relapse in acute lymphoblastic leukemia .


A prospective , longitudinal and experimental study was performed in patients with de novo acute lymphoblastic leukemia enrolled in the Hospital General de Mxico .


They were divided in two groups : first group received chemotherapy + metformin ( 850 mg three times a day ) ; second group only received standard chemotherapy .


The sample was randomized 3:1 in favor of the second group .


93 patients were included ( 73 treated with chemotherapy + metformin and 20 received standard chemotherapy ) , with 303 53 days of follow-up .


Complete remission was higher in the group without metformin ( 81.3 % [ n = 61 ] versus 70 % [ n = 14 ] ) , which also presented more patients with relapse ( 47.9 % versus 25 % ) .


Overall survival at one year was of 68 % and free survival disease was 64 % , without significant differences between groups .


Absence of metformin was the only variable of adverse prognostic considered significant ( p = 0.55 ) .


Cox regression showed that adding metfomin reduced 56 % the risk of relapse .


The adding metformin to the treatment of leukemias showed that was useful in our research .


However , randomized and double-blind studies must be designed in order to express final recommendations about its use .


To determine whether smaller brain volumes in older women who had completed Women 's Health Initiative ( WHI ) - assigned conjugated equine estrogen-based hormone therapy ( HT ) , reported by WHI Memory Study ( WHIMS ) - MRI , correspond to a continuing increased rate of atrophy an average of 6.1 to 7.7 years later in WHIMS-MRI2 .


A total of 1,230 WHI participants were contacted : 797 ( 64.8 % ) consented , and 729 ( 59 % ) were rescanned an average of 4.7 years after the initial MRI scan .


Mean annual rates of change in total brain volume , the primary outcome , and rates of change in ischemic lesion volumes , the secondary outcome , were compared between treatment groups using mixed-effect models with adjustment for trial , clinical site , age , intracranial volumes , and time between MRI measures .


Total brain volume decreased an average of 3.22 cm ( 3 ) / y in the active arm and 3.07 cm ( 3 ) / y in the placebo arm ( p = 0.53 ) .


Total ischemic lesion volumes increased in both arms at a rate of 0.12 cm ( 3 ) / y ( p = 0.88 ) .


Conjugated equine estrogen-based postmenopausal HT , previously assigned at WHI baseline , did not affect rates of decline in brain volumes or increases in brain lesion volumes during the 4.7 years between the initial and follow-up WHIMS-MRI studies .


Smaller frontal lobe volumes were observed as persistent group differences among women assigned to active HT compared with placebo .


Women with a history of cardiovascular disease treated with active HT , compared with placebo , had higher rates of accumulation in white matter lesion volume and total brain lesion volume .


Further study may elucidate mechanisms that explain these findings .


Surgical patients are at risk of adverse drug events ( ADEs ) causing morbidity and mortality .


Much harm is preventable .


Ward-based pharmacy interventions to reduce medication-related harm have not been evaluated in surgical patients .


This multicentre prospective clinical trial evaluated a protocolled , ward-based pharmacy method compared with standard pharmaceutical care in surgical patients .


Allocation of study group was done by one-time randomization at ward level .


Consecutive patients admitted for elective surgery with an expected hospital stay longer than 48 h were included .


Pharmacy practitioners performed bedside medication reconciliation at admission and discharge , and hospital pharmacists undertook regular medication reviews in the study wards .


Preventable ADEs and clinical outcomes were assessed .


A total of 1094 surgical patients were studied .


Some 880 specific interventions were made by the hospital pharmacist to improve pharmacotherapy in 309 of 547 patients on study wards .


A further 547 patients were included on control wards .


A crude non-significant reduction in incidence of preventable ADEs was seen on intervention wards in comparison with control wards ( 2.74 versus 3.84 preventable ADEs per 100 admissions ; incidence rate ratio 0.71 , 95 per cent c.i. 0.37 to 1.39 ; P = 0.324 ) .


After adjustment for differences in treatment groups and for potential confounding , the incidence rate ratio remained non-significant ( 0.82 , 0.39 to 1.72 ; P = 0.598 ) .


No differences were seen for other outcomes , such as duration of hospital stay , number of complications and quality of life .


The present prospective controlled trial showed no significant reduction in medication-related harm or changes in clinical outcomes when surgical patients received protocolled ward-based pharmacy interventions .


The Diabetes Control and Complications Trial ( DCCT ) showed a beneficial effect of 6.5 years of intensive glycemic control on retinopathy in patients with type 1 diabetes .


Between 1983 and 1989 , a total of 1441 patients with type 1 diabetes in the DCCT were randomly assigned to receive either intensive diabetes therapy or conventional therapy aimed at preventing hyperglycemic symptoms .


They were treated and followed until 1993 .


Subsequently , 1375 of these patients were followed in the observational Epidemiology of Diabetes Interventions and Complications ( EDIC ) study .


The self-reported history of ocular surgical procedures was obtained annually .


We evaluated the effect of intensive therapy as compared with conventional therapy on the incidence and cost of ocular surgery during these two studies .


Over a median follow-up of 23 years , 130 ocular operations were performed in 63 of 711 patients assigned to intensive therapy ( 8.9 % ) and 189 ocular operations in 98 of 730 patients assigned to conventional therapy ( 13.4 % ) ( P < 0.001 ) .


After adjustment for DCCT baseline factors , intensive therapy was associated with a reduction in the risk of any diabetes-related ocular surgery by 48 % ( 95 % confidence interval [ CI ] , 29 to 63 ; P < 0.001 ) and a reduction in the risk of all such ocular procedures by 37 % ( 95 % CI , 12 to 55 ; P = 0.01 ) .


Forty-two patients who received intensive therapy and 61 who received conventional therapy underwent cataract extraction ( adjusted risk reduction with intensive therapy , 48 % ; 95 % CI , 23 to 65 ; P = 0.002 ) ; 29 patients who received intensive therapy and 50 who received conventional therapy underwent vitrectomy , retinal-detachment surgery , or both ( adjusted risk reduction , 45 % ; 95 % CI , 12 to 66 ; P = 0.01 ) .


The costs of surgery were 32 % lower in the intensive-therapy group .


The beneficial effects of intensive therapy were fully attenuated after adjustment for mean glycated hemoglobin levels over the entire follow-up .


Intensive therapy in patients with type 1 diabetes was associated with a substantial reduction in the long-term risk of ocular surgery .


( Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others ; DCCT/EDIC ClinicalTrials.gov numbers , NCT00360893 and NCT00360815 . )


To compare the safety and efficacy of microcoaxial phacoemulsification surgeries performed with the OZil Intelligent Phaco torsional mode ( Alcon Laboratories , Inc. , Fort Worth , USA ) and combined torsional/longitudinal ultrasound mode using 45 degree aperture angled tips .


Prospective randomized clinical trial .


setting : Maltepe University , Istanbul .


patient population : Eighty eyes of 80 cataract patients were randomly assigned to 2.2 mm microcoaxial phacoemulsification using the OZil Intelligent Phaco torsional mode ( Group 1 ) or combined torsional/longitudinal ultrasound mode ( Group 2 ) .


observation procedure : Intraoperative fluid and energy usage and postoperative examinations were evaluated .


main outcome measures : Ultrasound time , cumulative dissipated energy , longitudinal and torsional ultrasound amplitudes , mean operation time , mean volume of fluid used , and surgical complications .


Both groups included 40 eyes .


Mean ultrasound time , cumulative dissipated energy , and longitudinal and torsional ultrasound amplitudes in Group 1 were 58.2133.81 seconds , 7.746.23 , 0.450.30 , and 26.3012.60 % , respectively , and these parameters in Group 2 were 64.7530.23 seconds , 12.616.21 , 26.325.85 , and 40.988.33 % , respectively .


Cumulative dissipated energy and longitudinal and torsional amplitudes were found to be significantly lower in Group 1 ( P = .001 , P < .001 , P < .001 ) .


Mean volumes of fluid used in Groups 1 and 2 were 73.3019.87 cc and 107.0721.82 cc , respectively ( P < .001 ) .


With the aid of a 45 degree aperture angled tip , the OZil Intelligent Phaco torsional mode provided more effective lens removal than the combined torsional/longitudinal ultrasound mode , with a lower cumulative dissipated energy and volume of fluid used .


The aim of this study was to investigate whether genetic variance can influence the efficacy of glibenclamide in patients with type 2 diabetes .


A total of 747 patients with type 2 diabetes was enrolled from the Xiaoke Pills Clinical Trial , which is a double-blind , randomised controlled trial .


All the patients had been treated with glibenclamide for 48 weeks , with strict drug dose adjustment and data collection .


Treatment failure was confirmed when patients reached the criteria for terminating their participation in the study ( fasting blood glucose level 7.0 mmol/l on two consecutive tests 4 weeks after reaching the pre-set maximal dose or maximal tolerated dose ) .


Using this cohort , we tested 44 single-nucleotide polymorphisms ( SNPs ) in 27 gene regions .


The genes in our study were involved in the metabolism of sulfonylureas , islet beta cell function , insulin resistance and beta cell growth and differentiation .


A logistic regression model was used to evaluate the relationship between genetic variants and treatment failure over a period of 48 weeks .


We found that no SNP reached the significance level of p < 0.00125 if Bonferroni correction was performed for multiple testing in the logistic regression model used in this pharmacogenetic study .


Participants with the minor allele C of rs10811661 in CDKN2A/CDKN2B showed a significantly greater reduction in fasting blood glucose ( TT vs TC vs CC : 9.3 % ( 0-20 .0 % ) vs 9.2 % ( 0.9-20 .5 % ) vs 12.7 % ( 5.2-24 .4 % ) , p = 0.008 ) after the initial 4 weeks of treatment independent of age , sex and BMI .


There was a significant difference in beta cell function among carriers of different genotypes of rs10811661 .


Our study demonstrated that the CDKN2A/CDKN2B gene may be nominally associated with the efficacy of glibenclamide , and that CDKN2A/CDKN2B is associated with beta cell function .


The effect of the Pillar implant on mild sleep-disordered breathing ( SDB ) has been assessed in various studies .


However , most of these were conducted among a non-Asian population at a single institution .


Therefore , the aim of this study was to prospectively evaluate the efficacy of the Pillar implant in Asian patients with simple snoring and mild obstructive sleep apnea ( OSA ) at multiple centers .


Multicenter prospective clinical trials .


This study included consecutive subjects with simple snoring or mild OSA .


We examined subjective symptoms ( snoring intensity , frequency , witnessed apnea , and daytime sleepiness ) and objective snoring and respiratory parameters ( snoring duration [ proportion of sleep while snoring louder than 50 dB ] , snoring loudness , apnea-hypopnea index , respiratory disturbance index , minimum arterial oxygen saturation , and oxygen desaturation index4 % ) at 3 to 6 months after surgery .


Adverse events were also investigated .


Twenty-nine subjects with mild SDB completed the study .


Whole group analysis found significant improvements in various subjective symptoms , but not in the objective snoring and respiratory parameters .


A subgroup analysis of subjects with mild OSA ( n = 11 ) found significant alleviation in various subjective symptoms , apnea-hypopnea index , respiratory disturbance index , and oxygen desaturation index4 % .


No major complication related to surgery was observed , and most minor adverse effects were resolved without morbidity .


In selected Korean patients , the Pillar implant significantly improved not only subjective symptoms of mild SDB but also respiratory disturbances in mild OSA .


2b .


The study objective was to determine the impact of diabetes on radial artery and saphenous vein graft occlusion and clinical outcomes more than 5 years after coronary artery bypass surgery in the multicenter Radial Artery Patency Study ( NCT00187356 ) .


A total of 529 patients aged less than 80 years with triple-vessel disease undergoing coronary bypass surgery participated in this study .


Angiographic follow-up occurred more than 5 years after surgery with annual clinical follow-up .


The primary objective was to compare the proportion of complete graft occlusion between radial artery and saphenous vein grafts among diabetic and nondiabetic persons .


Additional objectives included determining predictors of complete graft occlusion and comparison of major adverse cardiac events defined by cardiac death , late myocardial infarction , and reintervention .


There were 148 of 529 patients ( 27.8 % ) with diabetes ; 269 patients ( 83/269 [ 30.9 % ] diabetic ) underwent late angiography at mean of 7.71.5 years after surgery .


In diabetic patients , the proportion of complete graft occlusion was significantly lower in the radial grafts ( 4/83 [ 4.8 % ] ) than in the saphenous grafts ( 21/83 [ 25.3 % ] ) ( P = .0004 ) , and this was similar in nondiabetic patients ( P = .19 ) .


Multivariate modeling showed that the use of the radial artery and high-grade target vessel stenosis were protective against late graft occlusion , whereas female gender , smoking history , and elevated creatinine were associated with an increased risk ; interaction between diabetic status and conduit type also was significant ( P = .02 ) .


Major adverse cardiac events were higher in diabetic patients ( 23/148 [ 15.5 % ] vs 35/381 [ 9.2 % ] , P = .04 ) .


The use of the radial artery should be strongly considered in diabetic patients undergoing coronary bypass surgery , especially with high-grade target vessel stenosis .


Andropause and aging are associated with neuroendocrine dysfunctions .


Growth hormone and testosterone play a significant role in several processes affecting adaptation and thereby also everyday functioning .


The aim of this research project was to evaluate the effects of recombinant human growth hormone and testosterone enanthate injections on body mass and body composition , aerobic and anaerobic fitness and lipid profile in middle-aged men .


The research group was comprised of 14 men aged 45 - 60 years .


Two series of laboratory analyses were performed .


Independent tests were carried out at baseline and after 12 weeks of the experiment .


The data were analyzed using Statistica 9.1 software .


A two-way repeated measures ANOVA revealed a statistically significant effect of the intervention programme on fat-free mass ( ( 2 ) = 0.34 ) , total body fat ( ( 2 ) = 0.79 ) , total cholesterol ( ( 2 ) = 0.30 ) , high-density lipoprotein cholesterol ( ( 2 ) = 0.31 ) , low-density lipoprotein cholesterol ( ( 2 ) = 0.42 ) , triglyceride ( ( 2 ) = 0.28 ) , testosterone ( ( 2 ) = 0.52 ) , insulin-like growth factor 1 ( ( 2 ) = 0.47 ) and growth hormone ( ( 2 ) = 0.63 ) .


Furthermore , ANOVA revealed a statistically significant effect of the rhGH and T treatment on maximal oxygen uptake ( ( 2 ) = 0.63 ) , anaerobic threshold ( ( 2 ) = 0.61 ) and maximal work rate ( ( 2 ) = 0.53 ) .


It should be emphasized that the lipid profile was affected not only by rhGH + T replacement therapy , but also by the prescribed physical activity programme .


The strength and endurance fitness programme alone did not cause significant changes in body mass and composition , nor the anaerobic and aerobic capacity .


On the other hand , the rhGH = T treatment stimulated these changes significantly .


The objective of this study was to compare participation rates and clinical effectiveness of sedated esophagogastroduodenoscopy ( sEGD ) and unsedated transnasal endoscopy ( uTNE ) for esophageal assessment and Barrett 's esophagus ( BE ) screening in a population-based cohort .


This was a prospective , randomized , controlled trial in a community population .


Subjects 50 years of age who previously completed validated gastrointestinal symptom questionnaires were randomized ( stratified by age , sex , and reflux symptoms ) to one of three screening techniques ( either sEGD or uTNE in a mobile research van ( muTNE ) or uTNE in a hospital outpatient endoscopy suite ( huTNE ) ) and invited to participate .


Of the 459 subjects , 209 ( 46 % ) agreed to participate ( muTNE n = 76 , huTNE n = 72 , and sEGD n = 61 ) .


Participation rates were numerically higher in the unsedated arms of muTNE ( 47.5 % ) and huTNE ( 45.7 % ) compared with the sEGD arm ( 40.7 % ) , but were not statistically different ( P = 0.27 ) .


Complete evaluation of the esophagus was similar using muTNE ( 99 % ) , huTNE ( 96 % ) , and sEGD ( 100 % ) techniques ( P = 0.08 ) .


Mean recovery times ( min ) were longer for sEGD ( 67.3 ) compared with muTNE ( 15.5 ) and huTNE ( 18.5 ) ( P < 0.001 ) .


Approximately 80 % of uTNE subjects were willing to undergo the procedure again in future .


Respectively , 29 % and 7.8 % of participating subjects had esophagitis and BE .


Mobile van and clinic uTNE screening had comparable clinical effectiveness with similar participation rates and safety profile to sEGD .


Evaluation time with uTNE was significantly shorter .


Prevalence of BE and esophagitis in community subjects 50 years of age was substantial .


Mobile and outpatient unsedated techniques may provide an effective alternative strategy to sEGD for esophageal assessment and BE screening .


Although medical intervention is the first option for treatment of nasal polyps , surgery is still a therapeutic option for symptomatic cases that do not respond or partially respond to medical intervention .


However , there is a need for high-level evidence for the preoperative use of steroids in nasal polyposis surgery .


We aimed to assess the perioperative effect of preoperative use of oral prednisolone for advanced-stage diffuse nasal polyposis .


Prospective , double-blind , randomized , placebo-controlled study .


A visual analog scale ( VAS ) was evaluated for smell , nasal discharge , nasal obstruction , facial pressure , headache , butanol smell threshold , and peak nasal inspiratory flow ( PNIF ) before and after the use of study drug .


Perioperative bleeding volume , visibility of operative field , operative time , hospital stay , and complication rate were also evaluated .


The improvement in the corticosteroid group ( CG ) in the VAS scores , butanol thresholds , and PNIF values showed statistically significant differences compared to the placebo group ( PG ) ( P < .05 ) .


The perioperative bleeding volume , visibility score , operative time , and hospital stay for CG/PG were 141 mL/384 mL , 2.4 / 3.4 , 61 min/71 .6 min , and 1.1 day/1 .8 day , respectively ( P < .05 ) .


The difference between the complication rates for the two groups did not show any statistically significant difference ( P = .214 ) .


Preoperative administration of systemic corticosteroids improves the perioperative visibility by reducing blood loss and shortens the operation time .


We recommend the use of preoperative corticosteroid for the safety of the patients .


The optimum dose and duration have not been established and require further studies .


1b .


Observational studies suggest that hydroxychloroquine ( HCQ ) may reduce the risk of developing diabetes mellitus in patients with rheumatoid arthritis ( RA ) .


We examined the effect of HCQ on insulin resistance in subjects without diabetes mellitus with stable RA .


Twenty-three RA subjects not currently using HCQ completed a 16-week , double-blind crossover study .


Subjects were randomly allocated to receive HCQ ( 6.5 mg/kg/day ) or placebo for the first 8 weeks , followed by crossover to the other arm for the final 8 weeks .


Subjects underwent oral glucose tolerance testing and fasting lipid measurements at baseline , 8 weeks , and 16 weeks .


The change SD from baseline in insulin sensitivity index ( ISI ) , homeostatic model assessment for insulin resistance ( HOMA-IR ) , and lipid parameters were compared between placebo and HCQ using linear regression .


The mean patient age was 56 years , with 96 % women , and the median body mass index was 26.0 kg/m2 .


After 8 weeks of HCQ , the mean SD ISI increase was 0.4 2.9 compared with a small increase during placebo of 0.14 3.1 ( adjusted P = 0.785 ) , and the mean SD HOMA-IR decrease was 0.3 1.5 during HCQ versus a decrease of 0.42 1.4 during placebo ( adjusted P = 0.308 ) .


Small decreases in total cholesterol ( 12.7 mg/dl ) and low-density lipoprotein ( LDL ) cholesterol ( 12.4 mg/dl ) were observed during the HCQ treatment periods ( both adjusted P < 0.05 compared to placebo ) .


HCQ use for 8 weeks in patients without diabetes mellitus with stable RA produced no significant change in insulin resistance .


We observed small and statistically significant improvements in total and LDL cholesterol during HCQ treatment .


Breastfeeding has countless benefits to mothers , children and community at large , especially in developing countries .


Studies from Lebanon report disappointingly low breastfeeding exclusivity and continuation rates .


Evidence reveals that antenatal breastfeeding education , professional lactation support , and peer lay support are individually effective at increasing breastfeeding duration and exclusivity , particularly in low-income settings .


Given the complex nature of the breastfeeding ecosystem and its barriers in Lebanon , we hypothesize that a complex breastfeeding support intervention , which is centered on the three components mentioned above , would significantly increase breastfeeding rates .


A multi-center randomized controlled trial .


443 healthy pregnant women in their first trimester will be randomized to control or intervention group .


A `` prenatal/postnatal '' professional and peer breastfeeding support package continuing till 6 months postpartum , guided by the Social Network and Social Support Theory .


Control group will receive standard prenatal and postnatal care .


Mothers will be followed up from early pregnancy till five years after delivery .


Total and exclusive breastfeeding rates , quality of life at 1 , 3 and 6 months postpartum , maternal breastfeeding knowledge and attitudes at 6 months postpartum , maternal exclusive breastfeeding rates of future infants up to five years from baseline , cost-benefit and cost-effectiveness analyses of the intervention .


Descriptive and regression analysis will be conducted under the intention to treat basis using the most recent version of SPSS .


Exclusive breastfeeding is a cost-effective public health measure that has a significant impact on infant morbidity and mortality .


In a country with limited healthcare resources like Lebanon , developing an effective breastfeeding promotion and support intervention that is easily replicated across various settings becomes a priority .


If positive , the results of this study would provide a generalizable model to bolster breastfeeding promotion efforts and contribute to improved child health in Lebanon and the Middle East and North Africa ( MENA ) region .


Current Controlled Trials ISRCTN17875591 .


Beta-blockers ( BBs ) improve outcomes in heart failure .


Results from the Cardiac Insufficiency Bisoprolol Study in Elderly ( CIBIS-ELD ) trial previously demonstrated the feasibility of heart rate , not maximum dose , as a treatment goal .


In this pre-specified analysis , we investigated the prognostic value of achieved heart rate after BB optimization on long-term mortality .


Elderly heart failure patients from the CIBIS-ELD trial were invited to participate in a follow-up examination 4 years after the initial 12-week BB up-titration period .


The relationship between all-cause mortality , BB dose , and heart rate after titration and potentially confounding clinical variables was analysed by multivariable Cox regression .


In total , 728 patients ( 38 % women ; mean age 72.9 5.4 years ) were included .


During a mean follow-up period of 45 9 months , 134 patients ( 19 % ) died , thus accumulating 2268 patient-years at risk .


There was no significant difference in baseline heart rate for survivors and non-survivors ( P = 0.19 ) .


In models adjusting for age , sex , BB pre-treatment , ventricular function , heart rate , and NYHA class at baseline , a heart rate increase by 10 b.p.m. following up-titration was associated with a subsequent mortality hazard ratio of 1.19 ( 95 % confidence interval 1.02-1 .38 , P = 0.023 ) .


The heart rate range with the lowest mortality and the fewest treatment-related adverse events was 55-64 b.p.m.


The achieved BB dose was not associated with mortality risk .


The heart rate after up-titration , but not BB dose , predicted all-cause mortality risk in elderly patients with chronic heart failure .


These patients should be titrated to resting heart rates between 55 and 64 b.p.m.


Regional analgesic techniques are commonly used in pediatric urology .


Ultrasound guided transversus abdominis plane block has recently gained popularity .


However , there is a paucity of information supporting a benefit over regional field infiltration .


We present a parallel group , randomized , controlled trial evaluating ultrasound guided transversus abdominis plane block superiority over surgeon delivered regional field infiltration for children undergoing open pyeloplasty at a tertiary referral center .


Following ethics board approval and registration , children 0 to 6 years old were recruited and randomized to undergo perioperative transversus abdominis plane block or regional field infiltration for early post-pyeloplasty pain control .


General anesthetic delivery , surgical technique and postoperative analgesics were standardized .


A blinded assessor regularly captured pain scores in the recovery room using the FLACC ( Face , Legs , Activity , Cry , Consolability ) scale .


The primary outcome was the need for rescue morphine administration based on a FLACC score of 3 or higher .


Two pediatric urologists performed 57 pyeloplasties during a 2.5-year period , enrolling 32 children ( 16 in each group , balanced for age and weight ) .


There were statistically significant differences in the number of children requiring rescue morphine administration ( 13 of 16 receiving transversus abdominis plane block and 6 of 16 receiving regional field infiltration , p = 0.011 ) , mean SD total morphine consumption ( 0.066 0.051 vs 0.028 0.040 mg/kg , p = 0.021 ) and mean SD pain scores ( 5 5 vs 2 3 , p = 0.043 ) in the recovery room , in favor of surgeon administered regional field infiltration .


No local anesthetic specific adverse events were noted .


Ultrasound guided transversus abdominis plane block is not superior to regional field infiltration with bupivacaine as a strategy to minimize early opioid requirements following open pyeloplasty in children .


Instead , our data suggest that surgeon delivered regional field infiltration provides better pain control .


The addition of hydrophobically modified polymers ( HMPs ) to cleansers that contain surfactants can create polymer-surfactant complexes that are less irritating to the skin than commercially available mild cleansers .


Our objective was to compare the tolerability and efficacy of a test foaming liquid facial cleanser containing HMPs with a commercial liquid nonfoaming facial cleanser in women with sensitive skin .


In this randomized , prospective , double-blind , comparative study , women ( n = 20 per group ) with mild-to-moderate atopic dermatitis ( AD ) , eczema , acne , or rosacea used a test gentle foaming liquid facial cleanser containing HMPs or a commercial gentle liquid nonfoaming facial cleanser daily for 3weeks .


Investigators assessed irritation and skin condition .


Study subjects also assessed their skin properties and the performance of each cleanser .


Clinicians as well as study subjects consistently rated the test cleanser as effective or slightly more effective at improving symptoms than the commercial cleanser , although no significant differences between groups were observed .


At weeks 1 and 3 , respectively , more users of the commercial cleanser reported irritation ( 20 % and 10 % ) than users of the test cleanser ( 5 % and 5 % ) .


In addition , subject self-assessments of skin condition and cleansing properties were slightly more improved with the test cleanser than with the commercial cleanser .


Both the test foaming cleanser containing HMPs and the commercial nonfoaming cleanser were effective and well accepted by most women in the study .


Improvements were observed by both clinicians and subjects in the group using the test cleanser containing HMPs in all evaluated skin categories .


To determine the safety and effectiveness of electroacupuncture ( EA ) intervention combined with general anesthesia ( GA ) for craniocerebral tumor-removal surgery involving cerebral eloquent areas .


A total of 20 patients with cerebral tumors ( durosarcoma , neurogliocytoma , metastatic tumor ) involving the cerebral eloquent areas were recruited in the present summary .


They were equally divided into general anesthesia ( GA ) group and EA + GA group .


Patients of the EA + GA group were treated with EA stimulation ( 2 Hz/100 Hz ) of the bilateral Fengchi ( GB 20 ) , Shuaigu ( GB 8 ) and acupuncture stimulation of Quanliao ( SI 18 ) , Zulinqi ( GB 41 ) and Taichong ( LR 3 ) , and not given intubation during surgery .


Patients of the GA group were treated with intravenous administration of Propofol , Fentanyl , Midazolam , Isopropanol , etc. .


In addition , all the patients were given with controlled hypotension by intravenous injection of Propofol and Fentanyl .


Dosages of Propofol and Sulfentanyl used were recorded .


Karnofsky performance status scale was used to assess the patient 's general well-being and activities of daily life .


The craniocerebral tumor-removal surgery was successful in all the 20 patients .


Compared with the GA group , the dosages of Sulfentanyl and Propofol of the EA + GA group were significantly lower ( P < 0.05 ) .


No significant difference was found between the GA and EA + GA groups in Karnofsky performance scores ( P > 0.05 ) .


Patients of the EA+GA group experienced successful tumour-removal surgery without trachea cannula , were awake and could make a good cooperation with the operator during surgery .


They had no aggravation of neurofunctional disturbance following the operation .


EA combined with general anesthesia is safe and effective for patients with craniocerebral tumor-removal operations involving cerebral eloquent areas .


To determine if intrauterine administration of 5 cc of 2 % lidocaine in addition to paracervical block reduces pain during laminaria insertion , when compared with paracervical block and saline placebo .


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


Women presenting for abortion by dilation and evacuation ( D&E ) at 14-24 weeks gestational age were randomized to receive an intrauterine instillation of either 5 mL of 2 % lidocaine or 5 mL of normal saline , in addition to standard paracervical block with 20 cc of 0.25 % bupivacaine .


Our primary outcome was self-reported pain scores on a 100mm Visual Analogue Scale ( VAS ) immediately following laminaria insertion .


Secondary outcome was self-reported VAS pain score indicating the maximum level of pain experienced during the 24-48-h interval between laminaria insertion and D&E procedure .


Seventy-two women were enrolled , and data for 67 women were analyzed , only two of whom were more than 21 weeks on gestation .


The range of pain scores at both time points was large ( 1-90 mm at laminaria insertion ; 0-100mm in laminaria-D & E interval ) .


Mean pain scores were not different between treatment groups at laminaria insertion , ( 33 vs. 32 , p = .8 ) or in the laminaria - D&E interval ( 43 vs. 44 , p = .9 ) .


Intrauterine administration of 5 cc of 2 % lidocaine in addition to paracervical block did not reduce pain with laminaria insertion when compared to paracervical block with saline placebo .


Intrauterine lidocaine combined with paracervical block does not improve pain control at laminaria insertion when compared with paracervical block and saline placebo .


Wide variation in pain scores and persistent pain after laminaria insertion suggests patient would benefit from more effective methods of pain control at laminaria insertion and during the post-laminaria interval .


Our aim was to determine if a surgeon 's behaviors can encourage or discourage trainees from speaking up when they witness a surgical mistake .


A randomized clinical trial in which medical students ( n = 55 ) were randomly assigned to an `` encouraged '' ( n = 28 ) or `` discouraged '' ( n = 27 ) group .


Participants underwent personality tests to assess decision-making styles , and were then trained on basic tasks ( `` burn '' then `` cut '' ) on a laparoscopic surgery simulator .


After randomization , students assisted at a simulated laparoscopic salpingectomy .


The senior surgeon used either an `` encourage '' script ( eg , `` Your opinion is important . '' )


or a `` discourage '' script ( eg , `` Do what I say .


Save questions for next time . '' )


Otherwise , the surgery was conducted identically .


Subsequently , a surgical mistake was made by the senior surgeon when he instructed students to cut without burning .


Students were considered to have spoken up if they questioned the instruction and did not cut .


Potential personality bias was assessed with two validated personality tests before simulation .


Data were processed with Mann-Whitney and Fisher exact tests .


The students in the encouraged group were significantly more likely to speak up ( 23 of 28 [ 82 % ] vs 8 of 27 [ 30 % ] ; p < 0.001 ) .


There was no statistically significant difference between the two groups in personality traits , student training level ( p = 1.0 ) , or sex ( p = 0.53 ) .


A discouraging environment decreases the frequency with which trainees speak up when witnessing a surgical error .


The senior surgeon plays an important role in improving intraoperative communication between junior and senior clinicians and can enhance patient safety .


Despite growing emphasis on transitional care to reduce costs and improve quality , few studies have examined transitional care improvements in socioeconomically disadvantaged adults .


It is important to consider these patients separately as many are high-utilizers , have different needs , and may have different responses to interventions .


To evaluate the impact of a multicomponent transitional care improvement program on 30-day readmissions , emergency department ( ED ) use , transitional care quality , and mortality .


Clustered randomized controlled trial conducted at a single urban academic medical center in Portland , Oregon .


Three hundred eighty-two hospitalized low-income adults admitted to general medicine or cardiology who were uninsured or had public insurance .


Multicomponent intervention including ( 1 ) transitional nurse coaching and education , including home visits for highest risk patients ; ( 2 ) pharmacy care , including provision of 30 days of medications after discharge for those without prescription drug coverage ; ( 3 ) post-hospital primary care linkages ; ( 4 ) systems integration and continuous quality improvement .


Primary outcomes included 30-day inpatient readmission and ED use .


Readmission data were obtained using state-wide administrative data for all participants ( insured and uninsured ) .


Secondary outcomes included quality ( 3-item Care Transitions Measure ) and mortality .


Research staff administering questionnaires and assessing outcomes were blinded .


There was no significant difference in 30-day readmission between C-TraIn ( 30/209 , 14.4 % ) and control patients ( 27/173 , 16.1 % ) , p = 0.644 , or in ED visits between C-TraIn ( 51/209 , 24.4 % ) and control ( 33/173 , 19.6 % ) , p = 0.271 .


C-TraIn was associated with improved transitional care quality ; 47.3 % ( 71/150 ) of C-TraIn patients reported a high quality transition compared to 30.3 % ( 36/119 ) control patients , odds ratio 2.17 ( 95 % CI 1.30-3 .64 ) .


Zero C-TraIn patients died in the 30-day post-discharge period compared with five in the control group ( unadjusted p = 0.02 ) .


C-TraIn did not reduce 30-day inpatient readmissions or ED use ; however , it improved transitional care quality .


To compare the effect of heated , humidified , high-flow nasal cannula ( HHHFNC ) and nasal continuous positive airways pressure ( NCPAP ) on lung function and mechanics in preterm infants with respiratory distress syndrome ( RDS ) at the same level of retropharyngeal pressure ( Prp ) .


Randomised crossover trial .


Neonatal intensive care unit , Ospedale Maggiore Policlinico , Milan , Italy .


20 preterm infants ( gestational age : 311 wks ) with mild-moderate RDS requiring non-invasive respiratory support within 96 h after birth .


Infants were exposed to a randomised sequence of NCPAP and HHHFNC at different settings ( 2 , 4 and 6 cmHO for NCPAP and 2 , 4 , 6 L/min for HHHFNC ) to enable comparison at the same level of Prp .


Tidal volume by respiratory inductance plethysmography , pleural pressure estimated by oesophageal pressure , and gas exchange were evaluated at each setting and used to compute breathing pattern parameters , lung mechanics and work of breathing ( WOB ) .


A poor linear regression between flow and Prp was found during HHHFNC ( Prp = 0.3 +0.7 * flow ; r = 0.37 ) .


Only in 15 out of 20 infants it was possible to compare HHHFNC and NCPAP at a Prp of 2 and 4 cmHO .


No statistically significant differences were found in breathing pattern , gas exchange , lung mechanics and total WOB .


Resistive WOB in the upper airways was slightly but significantly higher during HHHFNC ( 0.65 ( 0.49 ; 1.09 ) vs 1.57 ( 0.85 ; 2.09 ) cmHO median ( IQR ) ) .


Despite differing mechanisms for generating positive airway pressure , when compared at the same Prp , NCPAP and HHHFNC provide similar effects on all the outcomes explored .


Recurrent airway obstruction ( RAO ) , an asthma-like disease , is 1 of the most common allergic diseases in horses in the northern hemisphere .


Hypersensitivity reactions to environmental antigens cause an allergic inflammatory response in the equine airways .


Cytosine-phosphate-guanosine-oligodeoxynucleotides ( CpG-ODN ) are known to direct the immune system toward a Th1-pathway , and away from the pro-allergic Th2-line ( Th2/Th1-shift ) .


Gelatin nanoparticles ( GNPs ) are biocompatible and biodegradable immunological inert drug delivery systems that protect CpG-ODN against nuclease degeneration .


Preliminary studies on the inhalation of GNP-bound CpG-ODN in RAO-affected horses have shown promising results .


The aim of this study was to evaluate the clinical and immunological effects of GNP-bound CpG-ODN in a double-blinded , placebo-controlled , prospective , randomized clinical trial and to verify a sustained effect post-treatment .


Twenty-four RAO-affected horses received 1 inhalation every 2 days for 5 consecutive administrations .


Horses were examined for clinical , endoscopic , cytological , and blood biochemical variables before the inhalation regimen ( I ) , immediately afterwards ( II ) , and 4 weeks post-treatment ( III ) .


At time points I and II , administration of treatment rather than placebo corresponded to a statistically significant decrease in respiratory effort , nasal discharge , tracheal secretion , and viscosity , AaDO2 and neutrophil percentage , and an increase in arterial oxygen pressure .


Administration of a GNP-bound CpG-ODN formulation caused a potent and persistent effect on allergic and inflammatory-induced clinical variables in RAO-affected horses .


This treatment , therefore , provides an innovative , promising , and well-tolerated strategy beyond conventional symptomatic long-term therapy and could serve as a model for asthma treatment in humans .


Some patients with lower leg amputations may be candidates for motorized prosthetic limbs .


Optimal control of such devices requires accurate classification of the patient 's ambulation mode ( eg , on level ground or ascending stairs ) and natural transitions between different ambulation modes .


To determine the effect of including electromyographic ( EMG ) data and historical information from prior gait strides in a real-time control system for a powered prosthetic leg capable of level-ground walking , stair ascent and descent , ramp ascent and descent , and natural transitions between these ambulation modes .


Blinded , randomized crossover clinical trial conducted between August 2012 and November 2013 in a research laboratory at the Rehabilitation Institute of Chicago .


Participants were 7 patients with unilateral above-knee ( n = 6 ) or knee-disarticulation ( n = 1 ) amputations .


All patients were capable of ambulation within their home and community using a passive prosthesis ( ie , one that does not provide external power ) .


Electrodes were placed over 9 residual limb muscles and EMG signals were recorded as patients ambulated and completed 20 circuit trials involving level-ground walking , ramp ascent and descent , and stair ascent and descent .


Data were acquired simultaneously from 13 mechanical sensors embedded on the prosthesis .


Two real-time pattern recognition algorithms , using either ( 1 ) mechanical sensor data alone or ( 2 ) mechanical sensor data in combination with EMG data and historical information from earlier in the gait cycle , were evaluated .


The order in which patients used each configuration was randomized ( 1:1 blocked randomization ) and double-blinded so patients and experimenters did not know which control configuration was being used .


The main outcome of the study was classification error for each real-time control system .


Classification error is defined as the percentage of steps incorrectly predicted by the control system .


Including EMG signals and historical information in the real-time control system resulted in significantly lower classification error ( mean , 7.9 % [ 95 % CI , 6.1 % -9.7 % ] ) across a mean of 683 steps ( range , 640-756 steps ) compared with using mechanical sensor data only ( mean , 14.1 % [ 95 % CI , 9.3 % -18.9 % ] ) across a mean of 692 steps ( range , 631-775 steps ) , with a mean difference between groups of 6.2 % ( 95 % CI , 2.7 % -9.7 % ] ( P = .01 ) .


In this study of 7 patients with lower limb amputations , inclusion of EMG signals and temporal gait information reduced classification error across ambulation modes and during transitions between ambulation modes .


These preliminary findings , if confirmed , have the potential to improve the control of powered leg prostheses .


To measure choroidal thickness on spectral-domain optical coherence tomography ( SD OCT ) images using automated algorithms and to correlate choroidal pathology with retinal changes attributable to diabetic macular edema ( DME ) .


Post hoc analysis of multicenter clinical trial baseline data .


SD OCT raster scans/fluorescein angiograms were obtained from 284 treatment-nave eyes of 142 patients with clinically significant DME and from 20 controls .


Three-dimensional ( 3D ) SD OCT images were evaluated by a certified independent reading center analyzing retinal changes associated with diabetic retinopathy .


Choroidal thicknesses were analyzed using a fully automated algorithm .


Angiograms were assessed manually .


Multiple endpoint correction according to Bonferroni-Holm was applied .


Main outcome measures were average retinal/choroidal thickness on fovea-centered or peak of edema ( thickest point of edema ) - centered Early Treatment Diabetic Retinopathy Study grid , maximum area of leakage , and the correlation between retinal and choroidal thicknesses .


Total choroidal thickness is significantly reduced in DME ( 175 23 m ; P = .0016 ) and nonedematous fellow eyes ( 177 20 m ; P = .009 ) of patients compared with healthy control eyes ( 190 23 m ) .


Retinal/choroidal thickness values showed no significant correlation ( 1-mm : P = .27 , r ( 2 ) = 0.01 ; 3-mm : P = .96 , r ( 2 ) < 0.0001 ; 6-mm : P = .42 , r ( 2 ) = 0.006 ) .


No significant difference was found in the 1 - or 3-mm circle of a retinal peak of edema-centered grid .


All other measurements of choroidal/retinal thickness ( DME vs healthy , DME vs peak of edema-centered , DME vs fellow , healthy vs fellow , peak of edema-centered vs healthy , peak of edema-centered vs fellow eyes ) were compared but no statistically significant correlation was found .


By tendency a thinner choroid correlates with larger retinal leakage areas .


Automated algorithms can be used to reliably assess choroidal thickness in eyes with DME .


Choroidal thickness was generally reduced in patients with diabetes if DME is present in 1 eye ; however , no correlation was found between choroidal/retinal pathologies , suggesting different pathogenetic pathways .


This update of a randomized , prospective study presents the effect of external beam radiation therapy ( EBRT ) on long-term overall survival , local control , and limb function following limb-sparing surgery ( LSS ) for the treatment extremity soft tissue sarcoma ( STS ) .


Following LSS , patients with extremity STS were randomized to receive EBRT or surgery alone .


All patients with high-grade STS received adjuvant chemotherapy .


Long-term follow-up was obtained through telephone interviews using a questionnaire based on validated methods .


Overall survival ( OS ) was determined by Kaplan-Meier method .


A total of 141 patients with extremity STS were randomized to receive adjuvant EBRT ( n = 70 ) or LSS alone ( n = 71 ) .


Median follow-up was 17.9 years .


The 10 - and 20-year survival was 77 % ( 95 % CI 66-85 % ) and 64 % ( 95 % CI 52-75 % ) for patients receiving LSS alone and 82 % ( 95 % CI 72-90 % ) and 71 % ( 95 % CI 59-81 % ) for patients receiving EBRT ( p = 0.22 ) .


Of the 54 patients who completed telephone interviews , the incidence of local recurrence during the follow-up period was 4 % ( 1 of 24 ) in the LSS alone cohort compared with 0 % ( 0 of 30 ) in those who received EBRT ( p = 0.44 ) .


Patients treated with EBRT tended to have more wound complications ( 17 vs. 12.5 % , p = 0.72 ) , clinically significant edema ( 25 vs. 12 % , p = 0.31 ) , and functional limb deficits ( 15 vs. 12 % , p = 0.84 ) .


Adjuvant EBRT following surgery for STS of the extremity provides excellent local control with acceptable treatment-related morbidity and no statistically significant improvement in overall survival .


In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer ( EORTC ) phase III clinical trials .


Here we report the results pertaining to the feasibility of conducting such research .


In this cross-sectional study , we recruited long-term , disease-free survivors from two mature EORTC clinical trials in testicular and prostate cancer from centres in Northern and Southern Europe , and the United Kingdom ( UK ) .


A number of challenges were encountered in recruiting participating centres , obtaining medical ethical approval and in recruiting survivors and collecting the health-related quality of life ( HRQoL ) data in a timely manner .


The efficiency with which the study could be conducted varied widely across centres and countries .


Time to obtain medical ethical approval for the study ranged from 1.5 to 25 months .


We encountered most problems with ethical approval in the UK , Italy and Belgium .


In most cases , data collection was completed within 3 months ( range 10 weeks-1 year ) .


Completed questionnaires were obtained from 68 % and 56 % , respectively , of the testicular and prostate cancer survivors who were approached .


HRQoL research among long-term survivors of EORTC phase III clinical trials is possible , but the process of ethical approval and data collection is a lengthy one .


To minimise many of the logistical problems , long-term follow-up of patients should be an integral part of future clinical trials .


Moreover , regulations governing medical ethical approval for clinical research within the EU should be carefully evaluated to facilitate long-term follow-up of cancer survivors in Europe .


The serum collection under the abdominal flap is the most common complication after a lipo-abdominoplasty .


The frequency of seroma increases further among obese patients , who have achieved massive weight loss after bariatric surgery .


The purpose of this study is to demonstrate the effectiveness of fibrin glues with a low concentration of thrombin in reducing seroma formation after a lipo-abdominoplasty .


Thirty patients , that had achieved a significant weight loss after an intervention of laparoscopic adjustable gastric banding ( LAGB ) , underwent a circular lipo-abdominoplasty at our bariatric surgery department .


Patients were divided into two groups of 15 subjects each : group A underwent traditional surgery ; in group B , we applied a slow-clotting variant of fibrin glue ( ARTISS , Baxter ) under the abdominal flap .


All subjects were evaluated clinically using an ultrasound device on postoperative day 15 .


We considered positive for seroma , those cases with a liquid collection greater than 20 cc .


The groups were homogeneous for age , BMI , male/female ratio , and diabetic or smoker patients .


The mean hospital stay was significantly longer in group A than in group B.


We found eight cases of serum collection > 20 cc in group A and only one case in group B. Hematoma , umbilicus necrosis , and surgical site infection occurred in both groups , but overall complication rate was lower in group B.


The use of a fibrin glue with a low concentration of thrombin could be useful during wound closure and may decrease seroma formation in postbariatric patients undergoing lipo-abdominoplasty .


Children with pulmonary hypertension routinely undergo pulmonary vascular resistance studies to assess the disease severity and vasodilator responsiveness .


It is vital that results are accurate and reliable and are not influenced by the choice of anaesthetic agent .


However , there are anecdotal data to suggest that propofol and inhalational agents have different effects on pulmonary vascular resistance .


A total of 10 children with pulmonary hypertension were selected sequentially to be included in the study .


To avoid confounding because of baseline anatomic or demographic details , a crossover protocol was implemented , using propofol or isoflurane , with time for washout in between each agent and blinding of the interventionalist .


Pulmonary and systemic vascular resistance were not significantly different when using propofol or isoflurane .


However , the calculated resistance fraction - ratio of pulmonary resistance to systemic resistance - was significantly lower when using propofol than when using isoflurane .


Although no difference in pulmonary vascular resistance was demonstrated , this pilot study suggests that the choice of anaesthetic agent may affect the calculation of relative pulmonary and systemic vascular resistance , and provides some preliminary evidence to favour propofol over isoflurane .


These findings require replication in a larger study , and thus they should be considered in future calculations to make informed decisions about the management of children with pulmonary hypertension .


Dirofilaria repens is the causative agent of subcutaneous dirofilariosis of dogs , other animals and humans .


This nematode is transmitted by mosquitoes of Aedes , Anopheles and Culex genera .


In dogs , the parasite may cause subclinical infection or cutaneous signs .


Recently , D. repens has emerged and spread in different geographical areas , with an increase of cases in dogs and humans .


Chemoprevention in dogs in endemic areas is the most reliable approach for controlling this infection .


This paper describes a randomized , blocked and multicentric clinical field study investigating the efficacy of an oral , chewable formulation containing milbemycin oxime/praziquantel ( Milbemax , Novartis Animal Health ) in the chemoprevention of subcutaneous dirofilariosis in dogs .


This study was conducted in endemic areas of Italy .


A total of 249 dogs , at two sites , negative for D. repens , were allocated into two groups ( i.e. Treated - T1 vs Untreated-T2 ) with a ratio of 1:1 , and subjected to clinical visits and blood sampling once monthly until the end of the study .


All blood samples were microscopically and genetically examined .


Animals belonging to T1 group received a minimum target dose of 0.5 mg/kg bodyweight of milbemycin oxime and 5 mg/kg of praziquantel in commercial tablets ( Milbemax ) according body weight once every 4 weeks .


Animals of group T2 were not treated with Milbemax but received , when necessary , specific parasiticide treatments .


The study duration was 336 2 days for each dog .


A total of 219 dogs completed the study ( i.e. 111 in T1 and 108 in T2 ) , while 30 dogs ( i.e. 13 in T1 , 17 in T2 ) were withdrawn for a variety of reasons unrelated to administration of Milbemax .


The percentages of animals not showing microfilariae of D. repens were 100 % ( 111 animals ) in T1 and 94.7 % ( 108 animals out of 114 ) in group T2 .


Milbemax was shown to be safe in treated dogs .


The results of this study confirm that the monthly use of Milbemax in dogs is effective and safe for the prevention of subcutaneous dirofilariosis in endemic areas .


We investigated whether medial cord stimulation is inferior to posterior cord stimulation for vertical infraclavicular block with respect to block success .


Ninety-six patients scheduled for upper limb surgery were randomly elicited a medial or posterior cord response for infraclavicular block using 40 mL of 0.5 % ropivacaine .


We assessed block success ( complete sensory block of the 5 nerves in the forearm at 50 minutes ) as the primary end point and block procedure characteristics and adverse events as secondary end points .


The block success rates did not differ significantly between medial and posterior cord stimulation ( 95.7 % [ 44/46 ] vs 91.7 % [ 44/48 ] , 95 % CI of difference , -7.4 % to 15.6 % ) , while the secondary end points were comparable in both groups .


Needle manipulation to elicit medial cord response is noninferior to posterior cord response of block success during neurostimulation-guided vertical infraclavicular block .


Pharmacokinetically guided ( PK-guided ) versus body surface area-based 5-fluorouracil ( 5-FU ) dosing results in higher response rates and better tolerability .


A paucity of data exists on PK-guided 5-FU dosing in the community setting .


Seventy colorectal cancer patients , from one academic and five community cancer centers , received the mFOLFOX6 regimen ( 5-FU 2,400 mg/m ( 2 ) over 46 hours every 2 weeks ) with or without bevacizumab at cycle 1 .


The 5-FU continuous-infusion dose was adjusted for cycles 2-4 using a PK-guided algorithm to achieve a literature-based target area under the concentration-time curve ( AUC ) .


The primary objective was to demonstrate that PK-guided 5-FU dosing improves the ability to achieve a target AUC within four cycles of therapy .


The secondary objective was to demonstrate reduced incidence of 5-FU-related toxicities .


At cycles 1 and 4 , 27.7 % and 46.8 % of patients achieved the target AUC ( 20-25 mg hour/L ) , respectively ( odds ratio [ OR ] : 2.20 ; p = .046 ) .


Significantly more patients were within range at cycle 4 compared with a literature rate of 20 % ( p < .0001 ) .


Patients had significantly higher odds of not being underdosed at cycle 4 versus cycle 1 ( OR : 2.29 ; p = .037 ) .


The odds of a patient being within range increased by 30 % at each subsequent cycle ( OR : 1.30 ; p = .03 ) .


Less grade 3/4 mucositis and diarrhea were observed compared with historical data ( 1.9 % vs 16 % and 5.6 % vs 12 % , respectively ) ; however , rates of grade 3/4 neutropenia were similar ( 33 % vs 25 % -50 % ) .


PK-guided 5-FU dosing resulted in significantly fewer underdosed patients and less gastrointestinal toxicity and allows for the application of personalized colorectal cancer therapy in the community setting .


To assess the side effects unrelated to disease activity and the acceptability of combined oral contraceptives ( COCs ) , progestin-only pills ( POPs ) and copper-releasing intrauterine devices ( IUDs ) in women with systemic lupus erythematosus ( SLE ) .


A randomized clinical trial including 162 women with SLE , assigned to COC ( n = 54 ) , POP ( n = 54 ) or IUD ( n = 54 ) .


Follow-up visits were conducted after 1 , 2 , 3 , 6 , 9 and 12 months of treatment to monitor the presence of symptoms , changes in body weight and blood pressure as well as the development of health problems other than those relating to lupus .


Reasons for discontinuation and satisfaction with the use of the assigned method were recorded at the end of treatment .


Statistical analysis included descriptive statistics , repeated measure analyses and Kaplan-Meier curves .


Significantly different discontinuation rates due to any reason [ 35 % , 55 % , 29 % ( p < 0.01 ) ] or nonmedical reasons [ ( 11 % , 31 % , 4 % ( p < 0.05 ) ] were observed among the COC , POP and IUD groups .


Nausea was most frequent among COC users , dysmenorrhea among IUD users and acne and hirsutism among POP users .


Mean blood pressures remained unchanged .


Mild increases in body weight were observed over time in all treatment groups .


Most women were satisfied with the use of the assigned contraceptive method .


Oral contraceptives and IUD are acceptable birth control methods for patients with lupus , when counseling and specialized health attention are provided ; however , the acceptability of POP appears to be inferior .


Side effects unrelated to lupus disease activity are not frequent reasons to discontinue the contraceptive methods .


This study delves into an area that has not been explored among patients with lupus .


Our findings on the associated side effects and reasons for discontinuing COCs , POPs or copper-bearing IUDs may be useful in improving contraceptive counseling for women with lupus .


Furthermore , they also heighten our knowledge on the reasons that may preclude the widespread use of effective contraceptives among lupus patients .


Post-inflammatory hyperpigmentation is a frequent concern when treating solar lentigines .


To assess the safety and efficacy of a triple combination cream with fluocinolone acetonide 0.01 % , hydroquinone 4 % and tretinoin 0.05 % as adjuvant to cryotherapy in the treatment of solar lentigines in hands dorsum , and in the prevention of post-inflammatory hyperpigmentation after cryotherapy .


This prospective , randomized , controlled , investigator-blinded , single-centre study enrolled 50 patients .


Twenty-five patients received a 2-week daily triple combination cream plus sunscreen pre-treatment and 25 received sunscreen alone .


After that , cryotherapy was performed in all patients followed by a 3-week recovery period .


After this period , patients received the same initial treatment and were followed up for 8weeks .


Melanin and erythema levels of a target and a control lentigo were objectively measured using a narrowband reflectance spectrophotometer .


Lentigines count , colour homogeneity and global improvement were also assessed .


The number of solar lentigines reduced in the first 2weeks only in patients who used the triple combination 257 vs. 228 ( P < 0.0001 ) , and reduced at the end of the study for both groups ( P < 0.0001 ) .


The melanin levels also reduced in the first 2weeks only in patients who used the triple combination 29769 vs. 27366 ( P < 0.0001 ) and reduced at the end of the study for both groups ( P < 0.0001 ) .


Erythema and residual blisters from cryotherapy were the reported adverse reactions .


Triple combination cream can be used to enhance the resolution of solar lentigines , and to significantly reduce melanin levels and lentigines count , improving treatment results .


It was well-tolerated and did not increase the occurrence of neither erythema nor other side-effects after the cryotherapy .


The purpose of this article is to investigate the efficacy and safety of frovatriptan plus dexketoprofen 25 or 37.5 mg ( FroDex25 or FroDex37 .5 , respectively ) compared to that of frovatriptan 2.5 mg ( Frova ) in menstrually related migraine ( MRM ) .


The aim of this article is to analyze a subgroup of 76 women who treated an MRM attack in this multicenter , randomized , double-blind , parallel-group study .


The primary end-point was the proportion of patients who were pain free ( PF ) at two hours .


Secondary end-points included pain-relief ( PR ) at two hours and 48 hours sustained pain free ( SPF ) .


PF rates at two hours were 29 % under Frova , 48 % under FroDex25 and 64 % under FroDex37 .5 ( p < 0.05 ) .


PR at two hours was Frova 52 % , FroDex25 81 % and FroDex37 .5 88 % , while 48 hours SPF was 18 % under Frova , 30 % under FroDex25 and 44 % under FroDex37 .5 .


Combining frovatriptan + dexketoprofen produced higher PF rates at two hours compared to Frova while maintaining efficacy at 48 hours .


Tolerability profiles were comparable .


Triage of HPV screen-positive women is needed to identify those with underlying cervical intraepithelial neoplasia grade 2/3 or worse ( CIN2/3 + ) .


Presently , cytology on a physician-taken cervical scrape is mostly accepted as triage test , but needs follow-up testing in order not to miss severe disease .


Here , we evaluated the performance of combined cytology and bi-marker CADM1/MAL-methylation analysis as triage test on physician-taken cervical scrapes of HPV positive women .


In this post-hoc analysis , we used 364 left-over HPV positive cytology triage samples of participants of a randomized controlled trial ( PROHTECT-3 : n = 46,001 ) performed in population-based cervical screening .


Study endpoints were CIN2 + and CIN3 + detection .