Hence , FNS should be vigilantly assessed in clinic for risk stratification along with other objective factors for gauging risk of adverse outcomes after CEA .


Excessive weight gain during pregnancy is a risk factor for postpartum weight retention and future weight gain and obesity .


Whether a behavioral intervention in pregnancy can reduce long-term weight retention is unknown .


This randomized trial tested whether a low-intensity behavioral intervention to prevent excessive gestational weight gain could increase the proportion of women who returned to prepregnancy weight by 12 mo postpartum .


Women ( n = 401 , 13.5 wk of gestation , 50 % normal weight , 50 % overweight/obese ) were randomly assigned into an intervention or control group ; 79 % completed the 12-mo assessment .


The telephone-based intervention targeted gestational weight gain , healthy eating , and exercise and was discontinued at delivery .


In modified intent-to-treat analyses that excluded women with miscarriages ( n = 6 ) , gestational diabetes ( n = 32 ) , or subsequent pregnancies ( n = 32 ) , the intervention had no significant effect on the odds of achieving prepregnancy weight at 12 mo postpartum ( n = 331 ; 35.4 % compared with 28.1 % ; P = 0.18 ) .


Completer analyses suggested that the intervention tended to increase the percentages of women who reached prepregnancy weight ( n = 261 ; 45.3 % compared with 35.3 % ; P = 0.09 ) and significantly reduced the magnitude of mean SD postpartum weight retained ( 1.4 6.3 compared with 3.0 5.7 kg ; P = 0.046 ) at 12 mo. .


Women in the intervention group reported higher dietary restraint through 6 mo postpartum ( P = 0.023 ) and more frequent self-monitoring of body weight ( P < 0.02 for all ) throughout the study .


A low-intensity behavioral intervention in pregnancy can reduce 12-mo postpartum weight retention and improve dietary restraint and self-weighing in study completers .


Future research is needed to test the long-term effects of more intensive behavioral interventions in pregnancy .


This trial was registered at clinicaltrials.gov as NCT01117961 .


To determine basal and stimulated C-peptide percentiles in North American children and adolescents at risk for type 1 diabetes ( T1D ) and to examine factors associated with this distribution in the Diabetes Prevention Trial-Type 1 ( DPT-1 ) .


We included 582 subjects aged 4-18 years at randomization in the DPT-1 trials .


A 2-h oral glucose tolerance test ( OGTT ) was performed at baseline and every 6 months during the 5-year follow-up period .


The percentile values of C-peptide after baseline OGTT were estimated according to age , BMI Z score ( BMIZ ) , and/or sex categories .


Conditional quantile regression was used to examine the relationship between C-peptide percentiles and various independent variables .


The basal and stimulated C-peptide levels increased significantly as age and BMIZ increased ( P < 0.05 ) .


Both age and BMIZ had a stronger impact on the upper quartile of C-peptide distributions than the lower quartile .


Sex was only significantly associated with stimulated C-peptide .


Higher stimulated C-peptide levels were generally observed in girls compared with boys at the same age and BMIZ ( P < 0.05 ) .


HLA type and number of positive antibodies and antibody titers ( islet cell antibody [ ICA ] , insulin autoantibody , GAD65A , and ICA512A ) were not significantly associated with C-peptide distribution after adjustment for age , BMIZ , and sex .


Age - , sex - , and BMIZ-specific C-peptide percentiles can be estimated for North American children and adolescents at risk for T1D .


They can be used as an assessment tool that could impact the recommendations in T1D prevention trials .


To investigate the effects of repeated botulinum toxin A ( BoNT-A ) injections combined with occupational therapy , including a splint , compared with occupational therapy alone on hand function in children with unilateral spastic cerebral palsy ( USCP ) , in all International Classification of Functioning , Disability and Health ( ICF ) domains .


This was a randomized controlled study , population-based and evaluator-blinded for primary outcome ( October 2004 to September 2010 ) .


Twenty children ( 14 males ; median age 3y 1mo ) with USCP , recruited at a rehabilitation centre in Sweden , were assigned to one of two parallel groups using concealed allocation .


In the course of one year , 10 children received occupational therapy , while 10 received repeated BoNT-A plus occupational therapy ( BoNT-A/OT ) .


Primary outcome ( Assisting Hand Assessment [ AHA ] ) , and secondary outcome measures ( range of movement [ ROM ] , and Canadian Occupational Performance Measure ) , were measured at baseline , 3 , 6 , 9 , and 12months .


AHA revealed a superior effect in the BoNT-A/OT group at 12months : 6 out of 10 improved compared with 1 out of 10 in the occupational therapy group ( p < 0.03 ) .


A 95 % Peskun exact confidence interval for the difference in proportions is given as 0.01 to 0.81 .


Secondary outcomes improved in both groups .


Repeated BoNT-A/OT appeared superior to occupational therapy alone for bimanual performance in young children with USCP .


Active ROM and goal performance improved in both groups .


It is unclear whether patients with early-stage Hodgkin 's lymphoma and negative findings on positron-emission tomography ( PET ) after three cycles of chemotherapy with doxorubicin , bleomycin , vinblastine , and dacarbazine ( ABVD ) require radiotherapy .


Patients with newly diagnosed stage IA or stage IIA Hodgkin 's lymphoma received three cycles of ABVD and then underwent PET scanning .


Patients with negative PET findings were randomly assigned to receive involved-field radiotherapy or no further treatment ; patients with positive PET findings received a fourth cycle of ABVD and radiotherapy .


This trial assessing the noninferiority of no further treatment was designed to exclude a difference in the 3-year progression-free survival rate of 7 or more percentage points from the assumed 95 % progression-free survival rate in the radiotherapy group .


A total of 602 patients ( 53.3 % male ; median age , 34 years ) were recruited , and 571 patients underwent PET scanning .


The PET findings were negative in 426 of these patients ( 74.6 % ) , 420 of whom were randomly assigned to a study group ( 209 to the radiotherapy group and 211 to no further therapy ) .


At a median of 60 months of follow-up , there had been 8 instances of disease progression in the radiotherapy group , and 8 patients had died ( 3 with disease progression , 1 of whom died from Hodgkin 's lymphoma ) ; there had been 20 instances of disease progression in the group with no further therapy , and 4 patients had died ( 2 with disease progression and none from Hodgkin 's lymphoma ) .


In the radiotherapy group , 5 of the deaths occurred in patients who received no radiotherapy .


The 3-year progression-free survival rate was 94.6 % ( 95 % confidence interval [ CI ] , 91.5 to 97.7 ) in the radiotherapy group and 90.8 % ( 95 % CI , 86.9 to 94.8 ) in the group that received no further therapy , with an absolute risk difference of -3.8 percentage points ( 95 % CI , -8.8 to 1.3 ) .


The results of this study did not show the noninferiority of the strategy of no further treatment after chemotherapy with regard to progression-free survival .


Nevertheless , patients in this study with early-stage Hodgkin 's lymphoma and negative PET findings after three cycles of ABVD had a very good prognosis either with or without consolidation radiotherapy .


( Funded by Leukaemia and Lymphoma Research and others ; RAPID ClinicalTrials.gov number , NCT00943423 . )


As stereotactic radiotherapy ( SRT ) becomes widespread , precise information including number , location , and margin of lesions is required when magnetic resonance ( MR ) imaging of brain metastasis is performed .


We compare methods using 2 separate injections and a single injection for the administration of a double dose of contrast medium for contrastenhanced MR imaging .


We divided 40 patients with brain metastasis into 2 groups of 20 patients .


Group A received 2 separate injections ( 0.2 + 0.2 mL/kg ) of contrast medium ( gadoteridol ) ; Group B received a single injection of the same total dose ( 0.4 mL/kg ) .


Group A underwent spin echo ( SE ) T1-weighted imaging ( T1WI ) and magnetization prepared rapid acquisition with gradient echo sequence ( MPRAGE ) after each injection , and Group B underwent the same MR studies at the same timing as Group A.


We evaluated the number , signal-to-noise ratio ( SNR ) , diameter , margin delineation , and volume of lesions and compared them between early and delayed studies by the 2 methods .


The number of detected lesions was largest in delayed studies of MPRAGE in both groups .


The SNR of the lesions was statistically lower in early studies of Group A than other studies .


Delayed studies of Group B showed statistically better margin delineation than other studies on both SE-T1WI and MPRAGE studies .


Diameter and enhanced volume were statistically significantly larger on delayed phase than early phase in both groups .


Use of a single injection of double-dose contrast medium and longer delay time may improve margin delineation of lesions for the study of brain metastasis .


Enhanced volume was larger on delayed phase , and it may influence selection of therapeutic strategy .


Patients with sciatica frequently complain about associated back pain .


It is not known whether there are prognostic relevant differences in Magnetic Resonance Imaging ( MRI ) findings between sciatica patients with and without disabling back pain .


The study population contained patients with sciatica who underwent a baseline MRI to assess eligibility for a randomized trial designed to compare the efficacy of early surgery with prolonged conservative care for sciatica .


Two neuroradiologists and one neurosurgeon independently evaluated all MR images .


The MRI readers were blinded to symptom status .


The MRI findings were compared between sciatica patients with and without disabling back pain .


The presence of disabling back pain at baseline was correlated with perceived recovery at one year .


Of 379 included sciatica patients , 158 ( 42 % ) had disabling back pain .


Of the patients with both sciatica and disabling back pain 68 % did reveal a herniated disc with nerve root compression on MRI , compared to 88 % of patients with predominantly sciatica ( P < 0.001 ) .


The existence of disabling back pain in sciatica at baseline was negatively associated with perceived recovery at one year ( Odds ratio [ OR ] 0.32 , 95 % Confidence Interval 0.18-0 .56 , P < 0.001 ) .


Sciatica patients with disabling back pain in absence of nerve root compression on MRI at baseline reported less perceived recovery at one year compared to those with predominantly sciatica and nerve root compression on MRI ( 50 % vs 91 % , P < 0.001 ) .


Sciatica patients with disabling low back pain reported an unfavorable outcome at one-year follow-up compared to those with predominantly sciatica .


If additionally a clear herniated disc with nerve root compression on MRI was absent , the results were even worse .


Vitamin D deficiency is associated with cardiovascular ( CV ) risk in multiple populations , including those with chronic kidney disease ( CKD ) .


The active form of the hormone ( 1,25 OH2D3 ) binds to receptors in multiple organs .


CKD patients are deficient in both 25 Vitamin D and 1,25 OH2D3 .


Clinical trial data demonstrating the benefits of vitamin D formulations are limited , and fail to show significant benefits on CV outcomes , and have compared different compounds , in various populations , and focused on a variety of outcomes .


A understanding of the mechanism by which different vitamin D compounds confer CV protection in CKD is important for the design of future studies .


This 3 arm randomized prospective double-blinded placebo-controlled study examining the impact of calcitriol ( 1,25 OH2D3 ) and 25-hydroxyvitamin D3 supplementation compared to placebo on vascular stiffness , as measured by pulse wave velocity ( PWV ) .


Patients are enrolled from 2 tertiary care institutions if they meet inclusion criteria ( stable estimated glomerular filtration rate ( eGFR ) between 15-45ml / min , < 5ml/min change in previous 6 months ) , on stable doses of renin-angiotensin aldosterone system blockade .


For those already receiving vitamin D therapies , a 3 month washout period before randomization is mandatory .


Treatment duration is 6 months ; medications are given thrice weekly in fixed doses .


The primary outcome measure is Vascular stiffness , measured non-invasively by pulse wave velocity ( PWV ) .


Other measurements include BP , kidney function and serial blood levels of biomarkers .


The primary analysis will compare any vitamin D therapy versus placebo for the primary outcome defined as the change of PWV from baseline to 6 months .


Analysis of covariance will be used to detect differences between vitamin D preparations in the magnitude of reduction in PWV .


This study is novel in that we are using a robust study design in CKD patients ( not on dialysis ) comparing placebo to different forms of vitamin D supplementation in fixed doses , irrespective of baseline values .


We hope to demonstrate the biological mechanistic effect of vitamin D supplementation on vascular function in order for this information to be used in designing larger randomized controlled trials .


Current Controlled Trials NCT01247311 .


Date of Registration : November 12 , 2010 .


Previous small-molecule antiangiogenics have compromised chemotherapy dose intensity in breast cancer .


We present a phase I trial of a novel selective agent , nintedanib , plus standard chemotherapy in early breast cancer .


Her-2-negative breast cancer patients with tumours larger than 2cm were eligible for dose-escalation trial ( classic 3 +3 method ) .


The recommended phase II dose ( RP2D ) was 150mg BID of nintedanib combined with standard dose of weekly paclitaxel followed by adriamycin plus cyclophosphamide .


The dose-limiting toxicity was transaminase elevation .


At the RP2D , the dose intensity was 100 % .


The pathologic complete response was 50 % .


The combination allows the delivery of full-dose intensity , while efficacy seems promising .


There is uncertainty whether cancer screening affects participant incentives for favourable lifestyle .


The present study investigates long-term effects of colorectal cancer ( CRC ) screening on lifestyle changes .


In 1999-2001 , men and women drawn from the population registry were randomised to screening for CRC by flexible sigmoidoscopy ( ` invited-to-screening ' arm ) or to no-screening ( control arm ) in the Norwegian Colorectal Cancer Prevention trial .


A subgroup of 3043 individuals in the ` invited-to-screening ' and 2819 in the control arm , aged 50-55years , randomised during 2001 had their lifestyle assessed by a questionnaire at inclusion and after 11years ( 42 % of cohort ) .


The outcome was 11-year changes in lifestyle factors ( body weight , smoking status , physical exercise , selected dietary habits ) and in total lifestyle score ( 0-4 points , translating to the number of lifestyle recommendations adhered to ) .


We compared outcomes in the two randomisation arms and attendees with positive versus negative findings .


Total lifestyle scores improved in both arms .


The improvement was smaller in the ` invited-to-screening ' arm ( score 1.43 at inclusion ; 1.58 after 11years ) compared with the control arm ( score 1.49 at inclusion ; 1.67 after 11years ) ; adjusted difference -0.05 ( 95 % CI -0.09 to -0.01 ; p = 0.03 ) .


The change in the score was less favourable in screening attendees with a positive compared with negative screening result ; adjusted difference -0.16 ( 95 % CI -0.25 to -0.08 ; p < 0.001 ) .


The present study suggests that possible unfavourable lifestyle changes after CRC screening are modest .


Lifestyle counselling may be considered as part of cancer screening programmes .


NCT00119912 .


Medication-overuse headache ( MOH ) is common in the general population , and most patients are managed in primary health care .


Brief Intervention ( BI ) has been used as a motivational technique for patients with drug and alcohol overuse , and may a have role in the treatment of MOH .


To explore GPs ' experiences using BI in the management of patients with MOH .


Qualitative study in Norwegian general practice .


Data were collected through four focus group interviews with 22 GPs who participated in an intervention study on BI for MOH .


Systematic text condensation was used to analyse transcripts from the focus group interviews .


The GPs experienced challenges when trying to convince patients that the medication they used to treat and prevent headache could cause headache , but labelling MOH as a diagnosis opened up a space for change .


GPs were able to use BI within the scope of a regular consultation , and they thought that the structured approach had a potential to change patients ' views about their condition and medication use .


Being diagnosed with medication overuse could bring about feelings of guilt in patients , and GPs emphasised that a good alliance with the patient was necessary for successful change using BI to manage MOH .


GPs experience BI as a feasible strategy to treat MOH , and the technique relies on a good alliance between the doctor and patient .


When using BI , GPs must be prepared to counter patients ' misconceptions about medication used for headache .


Preoperative Anxiety is a negative factor in anesthetic and surgical experience .


Among the strategies for reducing children 's anxiety , non-pharmacological strategies are as important as the pharmacological ones , but its validity is still controversial .


The aim of this study was to verify if the information provided to guardians interferes with child anxiety .


72 children , 4-8 years old , ASA I and II , undergoing elective surgical procedures and their guardians were randomly divided into two groups : control group ( CG ) = guardian received conventional information about anesthesia ; informative group ( IG ) = guardian received an information leaflet about anesthesia .


Children 's anxiety was assessed using the modified Yale Preoperative Anxiety Scale ( m-YPAS ) on two occasions : at the surgical theater waiting room ( WR ) and at the operating room ( OR ) .


Parents ' anxiety was assessed using the Hamilton Anxiety Scale ( HAM-A ) at the CT. .


There was no difference in demographic data between groups .


The level of anxiety in children showed no difference between groups at two measured times .


There was statistically significant difference in anxiety levels between WR and OR in both groups , p = 0.0019 for CG and p < 0.0001 for GI , as well as the prevalence of anxiety for CG ( 38.9 % WR and 69.4 % OR , p = 0.0174 ) and GI ( 19.4 % WR and 83.3 % OR , p < 0.0001 ) .


The anxiety level of guardians did not differ between groups .


Regardless of the quality of information provided to the guardians , the level and prevalence of anxiety in children were low at WR time and significantly increased at OR time .


Botulinum toxin A products have been used in aesthetics for more than 20 years .


To compare incobotulinumtoxinA with onabotulinumtoxinA in the treatment of crow 's feet .


This single-center , randomized , prospective , split-face , subject - and rater-blinded study with a clinical crossover evaluation comprised 2 consecutive treatment cycles , each of 3 months ' duration separated by 6 months ( i.e. , a 9-month treatment interval ) .


Fourteen subjects with symmetrical crow 's feet were assessed using the Merz 5-point scale for crow 's feet , after each treatment with incobotulinumtoxinA ( right side of the face ) and onabotulinumtoxinA ( left side ) , or vice versa ( 1:1 dose conversion ratio ) .


The treatment applied to each side of the face was reversed in Cycle 2 .


Crow 's feet severity at rest and maximum contraction was improved to a similar extent by both treatments , in both cycles and on both sides of the face .


Pooled data confirmed these results .


Improvements were maintained at the final visit , 3 months after treatment ( e.g. , left side at maximum contraction-onabotulinumtoxinA mean score : 2.21 [ baseline ] vs 0.93 [ 1 month ] vs 1.71 [ 3 months ] ; incobotulinumtoxinA mean score : 2.21 vs 0.86 vs 1.50 ) .


IncobotulinumtoxinA and onabotulinumtoxinA ( 1:1 dose conversion ratio ) were well tolerated , showing comparable efficacy and duration of treatment effect for crow 's feet .


Meningococcal conjugate vaccines protect individuals directly , but can also confer herd protection by interrupting carriage transmission .


We assessed the effects of meningococcal quadrivalent glycoconjugate ( MenACWY-CRM ) or serogroup B ( 4CMenB ) vaccination on meningococcal carriage rates in 18-24-year-olds .


In this phase 3 , observer-blind , randomised controlled trial , university students aged 18-24 years from ten sites in England were randomly assigned ( 1:1:1 , block size of three ) to receive two doses 1 month apart of Japanese Encephalitis vaccine ( controls ) , 4CMenB , or one dose of MenACWY-CRM then placebo .


Participants were randomised with a validated computer-generated random allocation list .


Participants and outcome-assessors were masked to the treatment group .


Meningococci were isolated from oropharyngeal swabs collected before vaccination and at five scheduled intervals over 1 year .


Primary outcomes were cross-sectional carriage 1 month after each vaccine course .


Secondary outcomes included comparisons of carriage at any timepoint after primary analysis until study termination .


Reactogenicity and adverse events were monitored throughout the study .


Analysis was done on the modified intention-to-treat population , which included all enrolled participants who received a study vaccination and provided at least one assessable swab after baseline .


This trial is registered with ClinicalTrials.gov , registration number NCT01214850 .


Between Sept 21 and Dec 21 , 2010 , 2954 participants were randomly assigned ( 987 assigned to control [ 984 analysed ] , 979 assigned to 4CMenB [ 974 analysed ] , 988 assigned to MenACWY-CRM [ 983 analysed ] ) ; 33 % of the 4CMenB group , 34 % of the MenACWY-CRM group , and 31 % of the control group were positive for meningococcal carriage at study entry .


By 1 month , there was no significant difference in carriage between controls and 4CMenB ( odds ratio 12 , 95 % CI 08-17 ) or MenACWY-CRM ( 09 , [ 06-13 ] ) groups .


From 3 months after dose two , 4CMenB vaccination resulted in significantly lower carriage of any meningococcal strain ( 182 % [ 95 % CI 34-308 ] carriage reduction ) , capsular groups BCWY ( 266 % [ 105-399 ] carriage reduction ) , capsular groups CWY ( 296 % [ 81-460 ] carriage reduction ) , and serogroups CWY ( 285 % [ 28-475 ] carriage reduction ) compared with control vaccination .


Significantly lower carriage rates were also noted in the MenACWY-CRM group compared with controls : 390 % ( 95 % CI 173-550 ) carriage reduction for serogroup Y and 362 % ( 156-517 ) carriage reduction for serogroup CWY .


Study vaccines were generally well tolerated , with increased rates of transient local injection pain and myalgia in the 4CMenB group .


No safety concerns were identified .


Although we detected no significant difference between groups at 1 month after vaccine course , MenACWY-CRM and 4CMenB vaccines reduced meningococcal carriage rates during 12 months after vaccination and therefore might affect transmission when widely implemented .


Novartis Vaccines .


Opioids have synergistic action with local anesthetics which may alter characteristics of epidural block .


Giving opioids to mother before delivery of baby is still fully not accepted with some fearing risk of neonatal depression .


Our primary aim was to evaluate the analgesic effect of addition of 50 g fentanyl to epidural 0.5 % bupivacaine in patients undergoing elective caesarean section using visual analog scale .


The secondary aim was to assess onset of analgesia , volume of drug required to achieve T6 level , grade and duration of motor block and Apgar score .


In this prospective , randomized , double blind , placebo controlled study 64 patients scheduled for elective caesarean section under epidural anesthesia were randomly divided into two groups of 32 each .


The fentanyl group received 1 ml of 50 g fentanyl and the saline group received 1 ml of normal saline mixed with 10 ml of 0.5 % bupivacaine for epidural anesthesia .


VAS score , time to achieve T6 level , dose of bupivacaine , intraoperative analgesic consumption and duration of analgesia , grade and duration of motor block and any adverse maternal and neonatal effects were noted .


Data was analyzed using Students t test , chi-square test and Mann-Whitney U-test .


The values of P < 0.05 were considered statistically significant .


Fentanyl improved the VAS score significantly ( 1.61.32 ) compared to the saline group ( 3.771.0 , P < 0.0001 ) .


It also reduced the intraoperaitve analgesic supplementation compared to the saline group .


( P = 0.031 ) .


The postoperative duration of analgesia was prolonged in the fentanyl group ( 275.8013.61 min ) compared to the saline group ( 191.4712.16 min , P < 0.0001 ) .


The other characteristics of epidural block were unaltered .


Addition of 50 g fentanyl to epidural 0.5 % bupivacaine significantly reduces the VAS score .


It also reduces intra-operative analgesia supplementation and prolongs the duration of postoperative analgesia without altering the other characteristics of block .


The neonatal outcome is not affected with addition of fentanyl before delivery of baby .


Transurethral resection of prostate is the gold standard operation for bladder outflow obstruction due to benign prostatic enlargement .


However , catheter removal day is variable .


The objective of this study was to compare early and delayed catheter removal groups in terms of length of hospital stay , weight of resected prostate , duration of resection , peri-operative blood transfusion , and postoperative complications .


This randomized controlled trial was carried out in Urology Unit-B , Institute of Kidney Diseases Peshawar from 1st September 2009 to 31st July 2011 .


Patients were selected by simple random sampling technique after taking informed consent and divided into two groups : Group A-standard catheter removal group and Group B-early catheter removal group .


The study excluded patients with large post-void urine volume , simultaneous internal urethrotomy and transurethral resection of prostate , co-morbidity and intra-operative complications .


Patients were discharged after removal of catheter if they voided successfully .


In Group-A the catheters were kept for more than one day according to the standard protocol of our ward .


The data were analysed using SPSS-17 .


The study included 320 patients , 163 in Group-A and 157 in Group-B .


Mean weight of resected tissue in Group-A was 46.67 9.133 grams ; it was 45.22 7.532 grams in group B. Mean catheter removal day was 4.13 1.65 days in Group-A ; and 1.23 0.933 days in Group-B .


Mean length of hospital stay was 3.57 days 1.028 in Group-A and 1.29 days 1.030 in Group-B ( p-value < 0.05 ) .


Length of hospital stay strongly correlated with the day of catheter removal .


There was no significant difference between the two groups in terms of postoperative complications .


Removal of catheter on first postoperative day after transurethral prostatectomy does not increase the postoperative complications and results in shorter hospital stay .


To compare the effects of intrauterine lidocaine , intrauterine lidocaine plus rectal diclofenac , and a placebo on analgesia and to determine the satisfaction of patients and surgeons in cases of endometrial biopsy .


The double-blind , randomised , placebo-controlled study was conducted in the Department of Obstetrics and Gynaecology of the Ondokuz Mayis University , Samsun , Turkey , from April 2013 to January 2014 , and comprised patients scheduled for in-office endometrial biopsy.They were divided into three groups : Group P , 5ml of 0.9 % saline intrauterine ; Group L , 5ml of 2 % lidocaine intrauterine ; and Group LD , 5ml of 2 % lidocaine intrauterine 10min before the procedure plus 50mg of rectal diclofenac sodium .


Haemodynamic changes and visual analogue scale scores were recorded during the preoperative period , when the cervix was grasped with a tenaculum , immediately after intrauterine instillation , during uterine curettage and at postoperative 10 min .


The patient and the surgeon were questioned about their satisfaction 15 min after the procedure .


SPSS 21 was used for statistical analysis .


The 90 patients in the study were divided into three equal groups of 30 ( 33.33 % ) each .


There were no statistically significant inter-group differences in age , bodyweight , parity , number of postmenopausal patients , haemodynamic parameters and American Society of Anesthesiologists scores ( p > 0.05 in all categories ) .


In Group P , the visual analogue scale score estimated when the cervix was grasped with the tenaculum was lower when compared with Group L and Group LD ( p = 0.029 and p = 0.007 , respectively ) .


At other measurement time points , the scores did not differ between the groups .


The groups did not differ with respect to patient and surgeon satisfaction and complication rates ( p > 0.05 ) .


Intrauterine lidocaine or intrauterine lidocaine plus rectal diclofenac application had no effect on visual analogue scale scores , patient satisfaction and vasovagal reaction .


To determine the effect of dantrolene premedication on various cardiovascular and biochemical variables and recovery in isoflurane-anesthetized horses .


6 healthy horses .


Each horse was anesthetized twice with a 21 - to 28-day washout period between anesthetic sessions .


Food was not withheld from horses before either session .


During each session , dantrolene ( 6 mg/kg in 2 L of water ) or water ( 2 L ) was administered via a nasogastric tube 1 hour before anesthesia was induced .


Anesthesia was maintained with isoflurane for 90 minutes , during which blood gas analyses and lithium-dilution cardiac output ( CO ) measurements were obtained every 10 minutes .


Serum creatine kinase activity was measured before and at 4 , 8 , and 12 hours after anesthesia .


When horses were premedicated with dantrolene , CO at 25 , 35 , and 45 minutes after induction of anesthesia was significantly lower than that when horses were premedicated with water after which time difficulty in obtaining valid measurements suggested a continued decrease in CO ; plasma potassium concentration progressively increased during anesthesia , whereas serum creatine kinase activity remained fairly stable and within reference limits through 12 hours after anesthesia ; and 2 of 6 horses developed cardiac arrhythmias that required medical intervention .


The quality of anesthetic recovery was slightly better when horses were premedicated with dantrolene versus water , although the time required for recovery did not differ significantly between treatments .


Results suggested that dantrolene premedication prevented muscle damage without affecting anesthetic recovery but impaired CO and precipitated hyperkalemia and cardiac arrhythmias in healthy isoflurane-anesthetized horses .


Co-occurring mental and substance use disorders are associated with worse outcomes than a single disorder alone .


In this exploratory subgroup analysis of a randomized trial , the authors hypothesized that providing chronic care management ( CCM ) for substance dependence in a primary care setting would have a beneficial effect among persons with substance dependence and major depressive disorder or posttraumatic stress disorder ( PTSD ) .


Adults ( N = 563 ) with alcohol dependence , drug dependence , or both were assigned to CCM or usual primary care .


CCM was provided by a nurse care manager , social worker , internist , and psychiatrist .


Clinical outcomes ( any use of opioids or stimulants or heavy drinking and severity of depressive and anxiety symptoms ) and treatment utilization ( emergency department use and hospitalization ) were measured at three , six , and 12 months after enrollment .


Longitudinal regression models were used to compare randomized arms within the subgroups of participants with major depressive disorder or PTSD .


Among all participants , 79 % met criteria for major depressive disorder and 36 % met criteria for PTSD at baseline .


No significant effect of CCM was observed within either subgroup for any outcome , including any use of opioids or stimulants or heavy drinking , depressive symptoms , anxiety symptoms , and any hospitalizations or number of nights hospitalized .


Among participants with depression , those receiving CCM had fewer days in the emergency department compared with the control group , but the finding was of only borderline significance ( p = .06 ) .


Among patients with co-occurring substance dependence and mental disorders , CCM was not significantly more effective than usual care for improving clinical outcomes or treatment utilization .


The World Health Organization ( WHO ) has in 2013 changed the diagnostic criteria for gestational diabetes mellitus ( GDM ) to acknowledge the putative effect of mildly elevated fasting plasma glucose ( FPG ) levels on pregnancy outcomes .


We aimed to determine the prevalence and risk factors of GDM comparing the previous WHO 1999 criteria to the WHO 2013 criteria in North India .


In a population-based screening programme , 5100 randomly selected North Indian women were studied using a cross-sectional design with a questionnaire , venous FPG and 2-h capillary plasma glucose ( PG ) after a 75 g oral glucose tolerance test performed between 24 and 28 weeks of pregnancy .


The prevalence of GDM was 35 % using WHO 2013 criteria vs 9 % using WHO 1999 criteria .


FPG measurements identified 94 % of WHO 2013 GDM cases as opposed to 11 % of WHO 1999 GDM cases .


In contrast , 2-h PG measurements identified only 13 % of WHO 2013 GDM cases compared with 96 % of the WHO 1999 GDM cases .


Using logistic regression with backward elimination , urban habitat , illiteracy , non-vegetarianism , increased BMI , Hindu religion and low adult height were all independent risk factors of GDM using the 1999 criteria , whereas only urban habitat , low adult height and increased age were independent risk factors of GDM using the 2013 criteria .


Intervention studies are needed to justify the WHO 2013 GDM criteria increasing the prevalence four fold to include more than one third of North Indian pregnant women .


Methylnaltrexone bromide ( MTNX ) is a peripherally acting mu-opioid receptor antagonist , prescribed for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care .


Studies have used this drug to determine if other opioid-induced effects besides constipation are altered by MTNX in humans and have suggested , based on their results , that these other effects are altered by peripheral opioid actions .


The primary objective of this report is to present results that provide indirect evidence that MTNX has centrally mediated effects , albeit slight , and secondarily to describe the effects of MTNX on psychopharmacological effects of morphine .


In a crossover , randomized , placebo-controlled , double-blind study , 29 healthy volunteers received 0.45 mg/kg MTNX or saline subcutaneously , followed by saline intravenously .


In three other conditions , 0.143 mg/kg of morphine sulfate administered intravenously was preceded by subcutaneous administration of 0 , 0.225 , or 0.45 mg/kg MTNX .


Before and after drug administration , subjective and physiological measures , including pupil diameter , were assessed .


Two separate analyses confirmed that 0.45 mg/kg MTNX alone induced a slight degree of miosis , a centrally mediated opioid agonist effect .


This dose had minimal subjective effects .


MTNX at either or both the 0.225 and 0.45 mg/kg dose reduced some subjective effects of morphine without altering miosis .


We present indirect evidence that MTNX crosses the blood-brain barrier in humans .


Therefore , whether the reductions in subjective effects of morphine by MTNX that were observed in past studies and in this study can be attributed to peripheral mechanisms is open to question .


The direct-acting platelet P2Y12 receptor antagonist ticagrelor can reduce the incidence of major adverse cardiovascular events when administered at hospital admission to patients with ST-segment elevation myocardial infarction ( STEMI ) .


Whether prehospital administration of ticagrelor can improve coronary reperfusion and the clinical outcome is unknown .


We conducted an international , multicenter , randomized , double-blind study involving 1862 patients with ongoing STEMI of less than 6 hours ' duration , comparing prehospital ( in the ambulance ) versus in-hospital ( in the catheterization laboratory ) treatment with ticagrelor .


The coprimary end points were the proportion of patients who did not have a 70 % or greater resolution of ST-segment elevation before percutaneous coronary intervention ( PCI ) and the proportion of patients who did not have Thrombolysis in Myocardial Infarction flow grade 3 in the infarct-related artery at initial angiography .


Secondary end points included the rates of major adverse cardiovascular events and definite stent thrombosis at 30 days .


The median time from randomization to angiography was 48 minutes , and the median time difference between the two treatment strategies was 31 minutes .


The two coprimary end points did not differ significantly between the prehospital and in-hospital groups .


The absence of ST-segment elevation resolution of 70 % or greater after PCI ( a secondary end point ) was reported for 42.5 % and 47.5 % of the patients , respectively .


The rates of major adverse cardiovascular events did not differ significantly between the two study groups .


The rates of definite stent thrombosis were lower in the prehospital group than in the in-hospital group ( 0 % vs. 0.8 % in the first 24 hours ; 0.2 % vs. 1.2 % at 30 days ) .


Rates of major bleeding events were low and virtually identical in the two groups , regardless of the bleeding definition used .


Prehospital administration of ticagrelor in patients with acute STEMI appeared to be safe but did not improve pre-PCI coronary reperfusion .


( Funded by AstraZeneca ; ATLANTIC ClinicalTrials.gov number , NCT01347580 . )


Despite being a critical survivorship care issue , there is a clear gap in current knowledge of the optimal treatment of sexual dysfunction in men with prostate cancer .


There is sound theoretical rationale and emerging evidence that exercise may be an innovative therapy to counteract sexual dysfunction in men with prostate cancer .


Furthermore , despite the multidimensional aetiology of sexual dysfunction , there is a paucity of research investigating the efficacy of integrated treatment models .


Therefore , the purpose of this study is to : 1 ) examine the efficacy of exercise as a therapy to aid in the management of sexual dysfunction in men with prostate cancer ; 2 ) determine if combining exercise and brief psychosexual intervention results in more pronounced improvements in sexual health ; and 3 ) assess if any benefit of exercise and psychosexual intervention on sexual dysfunction is sustained long term .


A three-arm , multi-site randomised controlled trial involving 240 prostate cancer survivors will be implemented .


Participants will be randomised to : 1 ) ` Exercise ' intervention ; 2 ) ` Exercise + Psychosexual ' intervention ; or 3 ) ` Usual Care ' .


The Exercise group will receive a 6-month , group based , supervised resistance and aerobic exercise intervention .


The Exercise + Psychosexual group will receive the same exercise intervention plus a brief psychosexual self-management intervention that addresses psychological and sexual well-being .


The Usual Care group will maintain standard care for 6 months .


Measurements for primary and secondary endpoints will take place at baseline , 6 months ( post-intervention ) and 1 year follow-up .


The primary endpoint is sexual health and secondary endpoints include key factors associated with sexual health in men with prostate cancer .


Sexual dysfunction is one of the most prevalent and distressing consequences of prostate cancer .


Despite this , very little is known about the management of sexual dysfunction and current health care services do not adequately meet sexual health needs of survivors .


This project will examine the potential role of exercise in the management of sexual dysfunction and evaluate a potential best-practice management approach by integrating pharmacological , physiological and psychological treatment modalities to address the complex and multifaceted aetiology of sexual dysfunction following cancer .


Australian New Zealand Clinical Trials Registry ACTRN12613001179729 .


In the context of multiple adversities , women are demonstrating resilience in rebuilding their futures , through participation in microfinance programs .


In addition to the economic benefits of microfinance , there is evidence to suggest that it is an effective vehicle for improving health .


The parent study is a community-based trial to evaluate the effectiveness of a livestock microfinance intervention , Pigs for Peace ( PFP ) , on health and economic outcomes with households in 10 villages in eastern Democratic Republic of Congo .


The analysis for this manuscript includes only baseline data from female participants enrolled in the ongoing parent study .


Multiple regression analysis was used to examine if livestock/animal asset value moderates the relationship between conflict-related traumatic events and current mental health symptoms .


The majority of women are 25 years or older , married , have on average 4 children in the home and have never attended school .


Nearly 50 % of women report having at least one livestock/animal asset at baseline .


Over the past 10 years , women report on average more than 4 ( M = 4.31 , SD 364 ) traumatic events ( range 0-18 ) .


Women reported symptoms consistent with PTSD with a mean score of 2.30 ( SD = 066 range 0-4 ) and depression with a mean score of 1.86 ( SD = 049 , range 0-3 .47 ) .


The livestock/animal asset value by conflict-related traumatic events interaction was significant for both the PTSD ( p = 0021 ) and depression ( p = 0002 ) symptom models .


The study provides evidence of the moderating affect of livestock/animal assets on mental health symptoms for women who have experienced conflict .


The findings supports evidence about the importance of livestock/animal assets to economics in rural households but expands on previous research by demonstrating the psychosocial effects of these assets on women 's health .


clinicaltrials.gov NCT02008708 .


Perioperative anxiety is a common and undesirable outcome in pediatric surgical patients .


The use of interactive tools to minimize perioperative anxiety is vastly understudied .


The main objective of the current investigation was to compare the effects of a tablet-based interactive distraction ( TBID ) tool to oral midazolam on perioperative anxiety .


We hypothesized that the TBID tool was not inferior to midazolam to reduce perioperative anxiety .


108 children , ages 1-11 years , presenting for outpatient surgical procedures were prospectively randomized to oral midazolam ( 0.5 mgkg ( -1 ) ; 20 mg max ) or TBID .


The primary outcome was the change in anxiety level from baseline to parental separation and anesthetic induction .


Other data collected included emergence delirium , parental satisfaction , time-to-PACU discharge , and posthospitalization behavior .


The mean difference ( 95 % CI ) in the increase of anxiety at parental separation between the TBID and the midazolam group was -9 ( -2.6 to -16.4 ) , P = 0.006 , demonstrating superiority to midazolam group ( one-sided P = 0.003 ) .


For children 2-11 years , the mean difference ( 95 % CI ) in anxiety at induction was significant between the TBID and midazolam groups , -14.0 ( -6.1 to -22.0 ) , P < 0.001 .


The median ( IQR ) time-to-PACU discharge was 111 ( 75-197 ) min in the midazolam group and 87 ( 55-137 ) min in the TBID group , P = 0.03 .


Decreased emergence delirium and increased parental satisfaction were also observed in the TBID group .


A TBID tool reduces perioperative anxiety , emergence delirium , and time-to-discharge and increases parental satisfaction when compared to midazolam in pediatric patients undergoing ambulatory surgery .


Many patients with coronary artery disease who are not candidates for revascularization have refractory angina despite standard medical therapy .


The balloon-expandable , stainless steel , hourglass-shaped , coronary-sinus reducing device creates a focal narrowing and increases pressure in the coronary sinus , thus redistributing blood into ischemic myocardium .


We randomly assigned 104 patients with Canadian Cardiovascular Society ( CCS ) class III or IV angina ( on a scale from I to IV , with higher classes indicating greater limitations on physical activity owing to angina ) and myocardial ischemia , who were not candidates for revascularization , to implantation of the device ( treatment group ) or to a sham procedure ( control group ) .


The primary end point was the proportion of patients with an improvement of at least two CCS angina classes at 6 months .


A total of 35 % of the patients in the treatment group ( 18 of 52 patients ) , as compared with 15 % of those in the control group ( 8 of 52 ) , had an improvement of at least two CCS angina classes at 6 months ( P = 0.02 ) .


The device was also associated with improvement of at least one CCS angina class in 71 % of the patients in the treatment group ( 37 of 52 patients ) , as compared with 42 % of those in the control group ( 22 of 52 ) ( P = 0.003 ) .


Quality of life as assessed with the use of the Seattle Angina Questionnaire was significantly improved in the treatment group , as compared with the control group ( improvement on a 100-point scale , 17.6 vs. 7.6 points ; P = 0.03 ) .


There were no significant between-group differences in improvement in exercise time or in the mean change in the wall-motion index as assessed by means of dobutamine echocardiography .


At 6 months , 1 patient in the treatment group had had a myocardial infarction ; in the control group , 1 patient had died and 3 had had a myocardial infarction .


In this small clinical trial , implantation of the coronary-sinus reducing device was associated with significant improvement in symptoms and quality of life in patients with refractory angina who were not candidates for revascularization .


( Funded by Neovasc ; COSIRA ClinicalTrials.gov number , NCT01205893 . )


Observational reports have linked vitamin D with chronic urticaria , yet no randomized controlled trial has been conducted .


To determine whether high-dose vitamin D supplementation would decrease Urticaria Symptom Severity ( USS ) scores and medication burden in patients with chronic urticaria .


In a prospective , double-blinded , single-center study , 42 subjects with chronic urticaria were randomized to high ( 4,000 IU/d ) or low ( 600 IU/d ) vitamin D3 supplementation for 12 weeks .


All subjects were provided with a standardized triple-drug therapy ( cetirizine , ranitidine , and montelukast ) and a written action plan .


Data on USS scores , medication use , blood for 25-hydroxyvitamin D , and safety measurements were collected .


Triple-drug therapy decreased total USS scores by 33 % in the first week .


There was a further significant decrease ( 40 % ) in total USS scores in the high , but not low , vitamin D3 treatment group by week 12 .


Compared with low treatment , the high treatment group demonstrated a trend ( P = .052 ) toward lower total USS scores at week 12 , which was driven by significant decreases in body distribution and number of days with hives .


Beneficial trends for sleep quality and pruritus scores were observed with high vitamin D3 .


Serum 25-hydroxyvitamin D levels increased with high vitamin D3 supplementation , but there was no correlation between 25-hydroxyvitamin D levels and USS scores .


There was no difference in allergy medication use between groups .


No adverse events occurred .


Add-on therapy with high-dose vitamin D3 ( 4,000 IU/d ) could be considered a safe and potentially beneficial immunomodulator in patients with chronic urticaria .


clinicaltrials.gov Identifier : NCT01371877 .


This study aimed to observe the preventive potential of different hydration solutions on contrast-induced nephropathy ( CIN ) after percutaneous coronary intervention .


We initially screened 627 patients who were admitted to the Division of Cardiology , Beijing Anzhen Hospital between October 2010 and October 2011 .


The research subjects were randomly divided into four groups and were given : normal physiological saline ( PS ) , sodium bicarbonate ( SB ) , oral administration of PS + N-acetylcysteine ( NAC ) ( PS + NAC ) , or oral administration of SB + NAC ( SB + NAC ) .


These patients were administered a hypotonic nonionic contrast agent , and the incidence of CIN in each group was observed .


The total incidence rate of CIN was 4.47 % , while the CIN incidence rates in the PS group , the SB group , the PS + NAC group and the SB + NAC group were 3.11 , 5.03 , 4.46 and 5.33 % , respectively .


The differences between these groups were not statistically significant ( P = 0.238 ) , and for patients with diabetes and/or renal dysfunction , the incidence rates of CIN among the four groups did not show statistically significant differences ( P = 0.238 , 0.156 , 0.287 ) .


Use of PS , SB , and NAC caused no significant reduction in the incidence of CIN , but in high-risk patients with diabetes and/or renal dysfunction , SB + NAC might be superior to the application of isotonic crystalloid solution .


Group treatment is delivered in youth correctional facilities , yet groups may be iatrogenic .


Few measures with demonstrated psychometric properties exist to track behaviors of individuals during groups .


The authors assessed psychometrics for the Group Process-Individual Level measure ( GP-IL ) of group treatment .


N = 152 teens were randomized to 1 of 2 groups ( 10 sessions each ) .


Adolescents , counselors , and observers rated teen behaviors at sessions 3 and 10 .


GP-IL assesses reinforcement for deviancy and positive behaviors , member rejection , and counselor connection and praise .


Internal consistency and 1-month stability were demonstrated .


Concurrent validity is supported by correlations with measures expected to be associated with group behavior ( e.g. , coping skills ) .


Counselors and observers rated more deviancy during interactive skills-building groups versus didactic psychoeducational groups ( P .005 ) .


Scales evidenced incremental validity .


GP-IL offers a sound method of tracking adolescent behaviors for professionals working with groups .


Counselors ratings were most reliable and valid overall .


A-type and B-type natriuretic peptides are established markers in chronic heart failure ( HF ) .


C-type natriuretic peptide ( CNP ) belongs to the same peptide family , but is predominantly localized in the endothelium .


The prognostic role of CNP in heart failure has not been established .


The aim of the study was to determine the prognostic power and clinical correlates of the N-terminal part of pro CNP ( NT-proCNP ) in patients with chronic HF .


In 567 hospitalized heart failure patients , NT-proCNP levels were measured at hospital discharge .


The primary endpoint was a combined endpoint of all-cause mortality and HF hospitalization after 18 months .


Heart failure with a preserved ejection fraction ( HFpEF ) was pre-defined as an LVEF > 40 % .


Mean ( SD ) age was 71 11 years , 62 % were male , mean LVEF was 32 14 % , and 23 % had HFpEF .


In multivariate linear regression , NT-proCNP levels showed a positive correlation with NT-proBNP levels and parameters of renal function , whereas a negative correlation with female sex and vascular endothelial growth factor was observed .


After 18 months follow-up , 240 patients reached the combined endpoint .


We observed interaction between NT-proCNP and LVEF for outcome ( P = 0.046 ) .


Multivariate analyses revealed NT-proCNP to be strongly predictive for the primary endpoint [ hazard ratio ( HR ) 1.78 , 95 % confidence interval ( CI ) 1.18-2 .67 , P = 0.006 ) in patients with HFpEF , but not in patients with a reduced ejection fraction ( HFrEF ) ( HR 1.07 , 95 % CI 0.81-1 .43 , P = 0.616 ) .


Finally , reclassification showed significant additive value in patients with HFpEF ( P < 0.001 ) , but not in those with HFrEF ( P = 0.453 ) .


NT-proCNP is a strong independent marker for outcome in patients with HFpEF , but not in those with HFrEF .


Thousands of children are living with advanced cancer ; yet patient-reported outcomes ( PROs ) have rarely been used to describe their experiences .


We aimed to describe symptom distress in 104 children age 2 years or older with advanced cancer enrolled onto the Pediatric Quality of Life and Evaluation of Symptoms Technology ( PediQUEST ) Study ( multisite clinical trial evaluating an electronic PRO system ) .


Symptom data were collected using age - and respondent-adapted versions of the PediQUEST Memorial Symptom Assessment Scale ( PQ-MSAS ) at most once per week .


Clinical and treatment data were obtained from medical records .


Individual symptom scores were dichotomized into high/low distress .


Determinants of PQ-MSAS scores were explored using linear mixed-effects models .


During 9 months of follow-up , PQ-MSAS was administered 920 times : 459 times in teens ( 99 % self-report ) , 249 times in children ages 7 to 12 years ( 96 % child/parent report ) , and 212 times in those ages 2 to 6 years ( parent reports ) .


Common symptoms included pain ( 48 % ) , fatigue ( 46 % ) , drowsiness ( 39 % ) , and irritability ( 37 % ) ; most scores indicated high distress .


Among the 73 PQ-MSAS surveys administered in the last 12 weeks of life , pain was highly prevalent ( 62 % ; 58 % with high distress ) .


Being female , having a brain tumor , experiencing recent disease progression , and receiving moderate - or high-intensity cancer-directed therapy in the prior 10 days were associated with worse PQ-MSAS scores .


In the final 12 weeks of life , receiving mild cancer-directed therapy was associated with improved psychological PQ-MSAS scores .


Children with advanced cancer experience high symptom distress .


Strategies to promote intensive symptom management are indicated , especially with disease progression or administration of intensive treatments .


To compare the tunnel enlargement of double-bundle ( DB ) anterior cruciate ligament reconstruction ( ACLR ) with and without suturing of autologous ruptured tissue to hamstring graft in patients with subacute anterior cruciate ligament injury .


Ten patients with subacute ( 3 months after injury ) anterior cruciate ligament rupture were randomly allocated to undergo DB ACLR with suturing of the ruptured tissue to hamstring graft ( n = 5 ) or conventional DB ACLR ( n = 5 ) .


When autologous ruptured tissue was used , remnant ruptured tissue was then harvested , divided into 4 pieces , placed between the loops at the distal and proximal portions of the graft , and secured with the suture .


As the primary endpoint , tunnel volume assessment by 3-dimensional multi-detector row computed tomography ( MDCT ) was performed 1 year after ACLR .


To assessthe efficacy of these procedures , the Lysholm score , anterior tibial translation ( measured with a KT-1000 arthrometer [ MEDmetric , San Diego , CA ] ) , and rotational instability ( measured by the pivot-shift test ) were evaluated after 2 years .


Tunnel volume enlargement between 3 weeks and 1 year after ACLR as assessed by 3-dimensional MDCT was significantly less for ACLR using ruptured tissue than for conventional ACLR , especially at the femoral site ( P < .05 ) .


However , the postoperative Lysholm score , anterior stability of the knee measured with the KT-1000 arthrometer , and rate of negative manual pivot-shift test results did not differsignificantly between the 2 groups .


There was no correlation to the clinical outcomes in terms of tunnel size .


The Lysholm score , anterior laxity measured with the KT-1000 arthrometer , and rotational instability according to the pivot-shift test did not differ significantly between ACLR using ruptured tissue and the conventional technique .


However , ACLR using ruptured tissue produced less femoral tunnel enlargement as assessed by MDCT , warranting further long-term follow-up to elucidate its effectiveness .


Level II , prospective comparative study .


Epidemiologic studies have linked high consumption of red and processed meat with risk of developing type 2 diabetes , whereas high dairy consumption has been associated with decreased risk , but interventions have been limited .


We compared the effects on insulin sensitivity of consuming a diet high in lean red meat with minimal dairy , a diet high in primarily low-fat dairy ( from milk , yogurt , or custard ) with no red meat , and a control diet that contained neither red meat nor dairy .


A randomized crossover study was undertaken with 47 overweight and obese men and women divided into 2 groups as follows : those with normal glucose tolerance and those with impaired fasting glucose or impaired glucose tolerance .


Participants followed the 3 weight-stable dietary interventions for 4 wk with glucose , insulin , and C-peptide measured by using oral-glucose-tolerance tests at the end of each diet .


Fasting insulin was significantly higher after the dairy diet than after the red meat diet ( P < 0.01 ) with no change in fasting glucose resulting in a decrease in insulin sensitivity after the high-dairy diet ( P < 0.05 ) as assessed by homeostasis model assessment of insulin resistance ( HOMA-IR ) .


A significant interaction between diet and sex was observed such that , in women alone , HOMA-IR was significantly lower after the red meat diet than after the dairy diet ( 1.33 0.8 compared with 1.71 0.8 , respectively ; P < 0.01 ) .


Insulin sensitivity calculated by using the Matsuda method was 14.7 % lower in women after the dairy diet than after the red meat diet ( P < 0.01 ) with no difference between diets in men .


C-peptide was not different between diets .


In contrast to some epidemiologic findings , these results suggest that high consumption of dairy reduces insulin sensitivity compared with a diet high in lean red meat in overweight and obese subjects , some of whom had glucose intolerance .


This trial was registered at the Australian New Zealand Clinical Trials Registry as ACTRN12613000441718 .


The short latency stretch reflex ( SLR ) is well described , but the stimulus that evokes the SLR remains elusive .


One hypothesis states that reflex size is proportional to muscle fiber stretch , so in this study we examined the relationship between these 2 parameters in human triceps surae muscles .


Achilles tendon taps and dorsiflexion stretches with different amplitudes and preactivation torques were applied to 6 participants while electromyography and muscle fascicle length changes were recorded in soleus and medial gastrocnemius ( MG ) .


In response to tendon taps , neither fascicle length nor velocity changes were correlated with SLR size in either muscle , but accelerometer peaks were observed immediately after hammer-tendon contact .


Similar results were obtained after dorsiflexion stretches .


Muscle fascicle stretch is poorly correlated with SLR size , regardless of perturbation parameters .


We attribute the SLR trigger to the transmission of vibration through the lower limb , rather than muscle fiber stretch .


Ingestion of long-chain n-3 PUFA effectively decreases serum triacylglycerol ( TAG ) levels and increases the Omega-3 Index , defined as the % of EPA and DHA in erythrocyte fatty acids .


However , it remains unclear whether there is a relationship between the Omega-3 Index increase ( O3I increase ) and the TAG level decrease ( TAG ) .


We hypothesized that TAG reduction is strongly depended on Omega-3 Index increase .


Secondary analyses of data from a former double-blind placebo-controlled trial in which 150 dyslipidemic statin-treated subjects were randomized to four capsules of fish oil daily either as re-esterified TAG or ethyl esters in identical doses ( 1.01 g EPA +0.67 g DHA ) or corn oil as a placebo for a period of six month .


108 subjects fulfilled the criteria of the current study protocol and were included in the analyses .


A weak but significant negative correlation between O3I and TAG was observed ( r = -0.211 , p < 0.05 ) .


However , the relation between O3I and serum TAG was not linear ( coefficients of determination R ( 2 ) : 0.044 ) .


After sub-grouping the study population into Omega-3 Index response groups , the group with a mean O3I of > 4 % after six months of n-3 PUFA treatment demonstrated the greatest TAG reduction .


A weak association between Omega-3 Index increase and TAG level decrease was found .


This may be explained by highly fluctuating TAG levels , a large inter-individual difference in response of the Omega-3 Index , a cohort of subjects with only slightly elevated TAG levels and high Omega-3 Index values at baseline , and possibly to insufficient statistical power .


Since there was no strong association between Omega-3 Index increase and the TAG level decrease , we conclude that changes in serum TAG levels are not a viable substitute for the Omega-3 Index to monitor treatment with EPA and DHA .


Noninvasive ventilation has been recommended to decrease mortality among immunocompromised patients with hypoxemic acute respiratory failure .


However , its effectiveness for this indication remains unclear .


To determine whether early noninvasive ventilation improved survival in immunocompromised patients with nonhypercapnic acute hypoxemic respiratory failure .


Multicenter randomized trial conducted among 374 critically ill immunocompromised patients , of whom 317 ( 84.7 % ) were receiving treatment for hematologic malignancies or solid tumors , at 28 intensive care units ( ICUs ) in France and Belgium between August 12 , 2013 , and January 2 , 2015 .


Patients were randomly assigned to early noninvasive ventilation ( n = 191 ) or oxygen therapy alone ( n = 183 ) .


The primary outcome was day-28 mortality .


Secondary outcomes were intubation , Sequential Organ Failure Assessment score on day 3 , ICU-acquired infections , duration of mechanical ventilation , and ICU length of stay .


At randomization , median oxygen flow was 9 L/min ( interquartile range , 5-15 ) in the noninvasive ventilation group and 9 L/min ( interquartile range , 6-15 ) in the oxygen group .


All patients in the noninvasive ventilation group received the first noninvasive ventilation session immediately after randomization .


On day 28 after randomization , 46 deaths ( 24.1 % ) had occurred in the noninvasive ventilation group vs 50 ( 27.3 % ) in the oxygen group ( absolute difference , -3.2 [ 95 % CI , -12.1 to 5.6 ] ; P = .47 ) .


Oxygenation failure occurred in 155 patients overall ( 41.4 % ) , 73 ( 38.2 % ) in the noninvasive ventilation group and 82 ( 44.8 % ) in the oxygen group ( absolute difference , -6.6 [ 95 % CI , -16.6 to 3.4 ] ; P = .20 ) .


There were no significant differences in ICU-acquired infections , duration of mechanical ventilation , or lengths of ICU or hospital stays .


Among immunocompromised patients admitted to the ICU with hypoxemic acute respiratory failure , early noninvasive ventilation compared with oxygen therapy alone did not reduce 28-day mortality .


However , study power was limited .


clinicaltrials.gov Identifier : NCT01915719 .


Whether the commonly used bacillus Calmette-Gurin ( BCG ) strains Connaught and Tice confer different treatment responses in non-muscle-invasive bladder cancer ( NMIBC ) is unknown .


To compare clinical efficacy , immunogenicity , and genetics of BCG Connaught and Tice .


A prospective randomized single-institution trial with treatment of 142 high-risk NMIBC patients with BCG Connaught or Tice .


Patients were randomized to receive six instillations of BCG Connaught or Tice .


For experimental studies , BCG strains were compared in C57Bl/6 mice .


Bladders and lymphoid tissues were analyzed by cytometry and the latter cultivated to detect live BCG .


BCG genomic DNA was sequenced and compared with reference genomes .


Recurrence-free survival was the primary end point of the clinical study .


The Kaplan-Meier estimator was used for estimating survival and time-to-event end points .


Nonparametric tests served for the analysis of the in vivo results .


Treatment with BCG Connaught conferred significantly greater 5-yr recurrence-free survival compared with treatment with BCG Tice ( p = 0.0108 ) .


Comparable numbers of patients experienced BCG therapy-related side effects in each treatment group ( p = 0.09 ) .


In mice , BCG Connaught induced stronger T-helper cell 1-biased responses , greater priming of BCG-specific CD8 ( + ) T cells , and more robust T-cell recruitment to the bladder than BCG Tice .


Genome sequencing of the BCG strains revealed candidate genes potentially involved in the differential clinical responses .


BCG strain may have an impact on treatment outcome in NMIBC immunotherapy .


We compared the efficacy of two commonly used bacillus Calmette-Gurin ( BCG ) strains for the treatment of NMIBC and found that treatment with BCG Connaught prevented recurrences more efficiently than BCG Tice .


Comparison of the immunogenicity of the two strains in mice indicated superior immunogenicity of BCG Connaught .


We also identified genetic differences that may explain the differential efficacy of the Connaught and Tice BCG strains .


NCT00003779 .


Early clinical trials conducted primarily in Japan have shown that TAS-102 , an oral agent that combines trifluridine and tipiracil hydrochloride , was effective in the treatment of refractory colorectal cancer .


We conducted a phase 3 trial to further assess the efficacy and safety of TAS-102 in a global population of such patients .


In this double-blind study , we randomly assigned 800 patients , in a 2:1 ratio , to receive TAS-102 or placebo .


The primary end point was overall survival .


The median overall survival improved from 5.3 months with placebo to 7.1 months with TAS-102 , and the hazard ratio for death in the TAS-102 group versus the placebo group was 0.68 ( 95 % confidence interval [ CI ] , 0.58 to 0.81 ; P < 0.001 ) .


The most frequently observed clinically significant adverse events associated with TAS-102 were neutropenia , which occurred in 38 % of those treated , and leukopenia , which occurred in 21 % ; 4 % of the patients who received TAS-102 had febrile neutropenia , and one death related to TAS-102 was reported .


The median time to worsening performance status ( a change in Eastern Cooperative Oncology Group performance status [ on a scale of 0 to 5 , with 0 indicating no symptoms and higher numbers indicating increasing degrees of disability ] from 0 or 1 to 2 or more ) was 5.7 months with TAS-102 versus 4.0 months with placebo ( hazard ratio , 0.66 ; 95 % CI , 0.56 to 0.78 ; P < 0.001 ) .


In patients with refractory colorectal cancer , TAS-102 , as compared with placebo , was associated with a significant improvement in overall survival .


( Funded by Taiho Oncology-Taiho Pharmaceutical ; RECOURSE ClinicalTrials.gov number , NCT01607957 . )


To assess whether standardised packs of the form introduced in Australia are associated with a reduction in acute craving and/or an increase in motivation to stop , and to replicate previous findings on perceptions of packaging , perceptions of smokers using it and perceived effects on behaviour .


Following abstinence of at least 12 h , 98 regular and occasional smokers were randomised to exposure to their own cigarette package , another branded package or a standardised package .


Craving ( QSU-brief ) , motivation to stop , both at baseline and post-exposure .


Ratings of 10 attributes concerning package design , perceived smoker characteristics and effects on behaviour , post-exposure only .


For craving , a mixed model ANCOVA showed a significant interaction of packaging and time of measurement ( F ( 2,94 ) = 8.77 , p < .001 , partial ( 2 ) = .16 ) .


There was no significant main effect or interaction for motivation to stop smoking ( p = .9 ) .


The standardised pack was perceived to be significantly less appealing and less motivating to buy cigarettes , smokers using them were perceived as less popular and cigarettes from them expected to taste worse .


Standardised cigarette packaging may reduce acute ( hedonic ) craving and is associated with more negative perceptions than branded packaging with less prominent health warnings .


Unguided nasojejunal feeding tube insertion success rates are low .


Controversy persists about how to safely and efficiently perform enteral nutrition ( EN ) in critically ill patients .


This study explores an innovative blind nasointestinal tube ( NIT ) insertion method and compares nasogastric and nasointestinal feeding .


Seventy critically ill patients admitted to the intensive care unit ( ICU ) were divided randomly into a nasogastric tube group ( NGT ; n = 35 ) and an NIT group ( NIT ; n = 35 ) .


After bedside NGT and blind-type NIT insertion , tube position was assessed and EN was started on day 1 .


Patients ' nutritional status parameters , mechanical ventilation duration , average ICU stay , nutritional support costs , and feeding complications were compared .


Pre-albumin and transferrin levels on days 7 and 14 were significantly higher in the NIT group than in the NGT group ( p < 0.01 , p < 0.05 ) .


Bloating , diarrhea , upper gastrointestinal bleeding , and liver damage did not differ significantly between groups ( p > 0.05 ) .


Interleukin-6 and tumor necrosis factor - levels and APACHE II score were significantly lower in the NIT group than in the NGT group ( p < 0.01 , p < 0.05 ) .


Reflux and pneumonia incidences , mechanical ventilation duration , average ICU stay length , and nutritional support costs were significantly lower in the NIT group than in the NGT group ( p < 0.01 ) .


Blind bedside NIT insertion is convenient and its use can effectively improve nutritional status , reduce feeding complications , and decrease nutritional support costs of critically ill patients .


The common cold and other viral airway infections are highly prevalent in the population , and their treatment often requires the use of medications for symptomatic relief .


Paracetamol is as an analgesic and antipyretic ; chlorphenamine is an antihistamine ; and phenylephrine , a vasoconstrictor and decongestant .


This randomized , double-blind , placebo-controlled trial sought to evaluate the efficacy and safety of a fixed-dose combination of paracetamol , chlorphenamine and phenylephrine in the symptomatic treatment of the common cold and flu-like syndrome in adults .


This study enrolled 146 individuals aged 18 to 60years who had moderate to severe flu-like syndrome or common cold .


After clinical examination and laboratory tests , individuals were randomly assigned to receive the fixed-dose combination ( 73 ) or placebo ( 73 ) , five capsules per day for 48 to 72hours .


The primary efficacy endpoint was the sum of the scores of 10 symptoms on a four-point Likert-type scale .


To evaluate treatment safety , the occurrence of adverse events was also measured .


Mean age was 33.5 ( 9.5 ) years in the placebo group and 33.8 ( 11.5 ) in the treatment group .


There were 55 women and 18 men in the placebo group , and 46 women and 27 men in the treatment group .


Comparison of overall symptom scores in the two groups revealed a significantly greater reduction in the treatment group than in the placebo group ( p = 0.015 ) .


Analysis at the first 13 dose intervals ( 66h of treatment ) showed a greater reduction of symptom scores in the treatment group than in the placebo group ( p < 0.05 ) .


The number and distribution of adverse events were similar in both groups .


A fixed-dose combination of paracetamol , chlorphenamine and phenylephrine was safe and more effective than placebo in the symptomatic treatment of the common cold or flu-like syndrome in adults .


NCT01389518 .


Some evidence suggests that proton pump inhibitors ( PPIs ) are an under-appreciated risk factor for hypomagnesemia .


Whether hospitalization with hypomagnesemia is associated with use of PPIs is unknown .


We conducted a population-based case-control study of multiple health care databases in Ontario , Canada , from April 2002 to March 2012 .


Patients who were enrolled as cases were Ontarians aged 66 years or older hospitalized with hypomagnesemia .


For each individual enrolled as a case , we identified up to four individuals as controls matched on age , sex , kidney disease , and use of various diuretic classes .


Exposure to PPIs was categorized according to the most proximate prescription prior to the index date as current ( within 90 days ) , recent ( within 91 to 180 days ) , or remote ( within 181 to 365 days ) .


We used conditional logistic regression to estimate the odds ratio for the association of outpatient PPI use and hospitalization with hypomagnesemia .


To test the specificity of our findings we examined use of histamine H2 receptor antagonists , drugs with no causal link to hypomagnesemia .


We studied 366 patients hospitalized with hypomagnesemia and 1,464 matched controls .


Current PPI use was associated with a 43 % increased risk of hypomagnesemia ( adjusted odds ratio , 1.43 ; 95 % CI 1.06-1 .93 ) .


In a stratified analysis , the risk was particularly increased among patients receiving diuretics , ( adjusted odds ratio , 1.73 ; 95 % CI 1.11-2 .70 ) and not significant among patients not receiving diuretics ( adjusted odds ratio , 1.25 ; 95 % CI 0.81-1 .91 ) .


We estimate that one excess hospitalization with hypomagnesemia will occur among 76,591 outpatients treated with a PPI for 90 days .


Hospitalization with hypomagnesemia was not associated with the use of histamine H2 receptor antagonists ( adjusted odds ratio 1.06 ; 95 % CI 0.54-2 .06 ) .


Limitations of this study include a lack of access to serum magnesium levels , uncertainty regarding diagnostic coding of hypomagnesemia , and generalizability of our findings to younger patients .


PPIs are associated with a small increased risk of hospitalization with hypomagnesemia among patients also receiving diuretics .


Physicians should be aware of this association , particularly for patients with hypomagnesemia .


Please see later in the article for the Editors ' Summary .


Delayed-onset muscle soreness ( DOMS ) often occurs after unaccustomed eccentric exercise and reduces exercise performance .


We aimed to study the preventive effects of saffron and indomethacin on the biochemical and functional indicators of DOMS after 1-session eccentric exercise .


A 10-day , randomized , double-blind , placebo-controlled , pretest-posttest design .


Controlled research laboratory .


Thirty-nine nonactive male university students randomly divided into saffron ( n = 12 ) , indomethacin ( n = 12 ) , and control ( n = 15 ) groups .


Saffron group received 1 capsule containing dried saffron powder ( n = 12 , 300 mg/d ) , indomethacin group received 75 mg indomethacin ( n = 12 , 25 mg thrice a day ) , and control group ( n = 15 ) received placebo capsules , 1 week before and 3 days after eccentric exercise .


Ten days before and 24 , 48 , and 72 hours after muscle soreness protocol , the maximum isometric and isotonic forces , plasma creatine kinase ( CK ) , plasma lactate dehydrogenase ( LDH ) , perceived pain , knee range of movement , and thigh circumference were measured .


Muscle soreness protocol was performed with a weight load equal to 80 % of the maximum isotonic force in 4 sessions with 20 repetitions and 3-minute rest in between .


This study shows that 10-day supplementation with 300 mg saffron significantly decreased the CK and LDH concentrations ( P < 0.0001 ) .


In the saffron group , there was no decline in maximum isometric and isotonic forces after eccentric exercise , but a significant decline in the isometric force was observed in the control group ( P < 0.0001 ) .


No pain was reported in the saffron group , whereas the indomethacin group experienced pain before 72 hours ( P < 0.001 ) .


Results obtained from the current novel research indicate a strong preventive effect of 10-day supplementation with saffron on the DOMS .


The saffron can be used to prevent DOMS and alleviate the DOMS symptoms .


The evaluation of new long-lasting insecticidal bed nets ( LLINs ) is coordinated by the WHO Pesticide Evaluation Scheme ( WHOPES ) .


In 2007 , Netprotect was granted WHOPES interim recommendation after Phase I and II evaluations .


Present study evaluates Netprotect in a Phase III trial in rural Cambodia .


A randomized , prospective longitudinal study design was used to assess the performance of Netprotect over a period of three years , using conventionally-treated nets and a WHOPES recommended LLIN ( PermaNet 2.0 ) as positive controls .


The primary outcomes were the physical integrity , insecticide content and cone bioassay performance using .


The baseline deltamethrin concentration of 43 % of Netprotect nets were below the tolerance limit while 27 % of PermaNet 2.0 nets were above the target dose limits .


By 36 months Netprotect retained 35 % while PermaNet 2.0 retained 49 % of baseline insecticide dose .


Moreover the proportion of the inactive deltamethrin R-alpha isomer in the Netprotect nets was 33 % at the baseline and increased to 69 % after three years while it was low and almost constant for PermaNet 2.0 ( 3-7 % ) .


Only 71 % of Netprotect met the WHO criteria for bio-efficacy after three years while at least 80 % is required .


Moreover Netprotect nets failed for the WHOPES criteria after 12 and 24 months .


The reference LLIN met the WHOPES criteria throughout the study .


Over the entire three years the reference LLIN did obtain significant higher mosquito mortality than Netprotect .


The physical integrity was based on the proportionate hole index and after three years , 25 % of Netprotect and 30 % of PermaNet 2.0 were in a mediocre or poor state .


Netprotect did not meet the minimum WHO criteria for bio-efficacy after 12 , 24 and 36 months .


The use of a reference LLIN as positive control was helpful for data interpretation .


However , for future three-year studies , it is essential that before initiating any study nets should be checked for their specifications and this for both the candidate LLIN as well as for the reference LLIN .


Moreover , to improve the accuracy of the success rate of the candidate LLIN more nets should be tested for their bio-efficacy at the end of the trial .


Accreditation of healthcare organizations is a widely used method to assess and improve quality of healthcare .


Our aim was to determine the effectiveness of improvement plans in practice accreditation of primary care practices , focusing on cardiovascular risk management ( CVRM ) .


A two-arm cluster randomized controlled trial with a block design was conducted with measurements at baseline and follow-up .


Primary care practices allocated to the intervention group ( n = 22 ) were instructed to focus improvement plans during the intervention period on CVRM , while practices in the control group ( n = 23 ) could focus on any domain except on CVRM and diabetes mellitus .


Primary outcomes were systolic blood pressure < 140 mmHg , LDL cholesterol < 2.5 mmol/l and prescription of antiplatelet drugs .


Secondary outcomes were 17 indicators of CVRM and physician 's perceived goal attainment for the chosen improvement project .


No effect was found on the primary outcomes .


Blood pressure targets were reached in 39.8 % of patients in the intervention and 38.7 % of patients in the control group ; cholesterol target levels were reached in 44.5 % and 49.0 % respectively ; antiplatelet drugs were prescribed in 82.7 % in both groups .


Six secondary outcomes improved : smoking status , exercise control , diet control , registration of alcohol intake , measurement of waist circumference , and fasting glucose .


Participants ' perceived goal attainment was high in both arms : mean scores of 7.9 and 8.2 on the 10-point scale .


The focus of improvement plans on CVRM in the practice accreditation program led to some improvements of CVRM , but not on the primary outcomes .


ClinicalTrials.gov NCT00791362 .


The purpose of the study was to compare the efficacy and adverse events of dezocine with that of fentanyl or placebo for the control of emergence agitation .


114 children scheduled for adenotonsillectomy under sevoflurane anesthesia were allocated randomly into 1 of the 3 groups to receive dezocine 0.1 mgxkg ( -1 ) ( group D , n = 38 ) , fentanyl 1 gkg ( -1 ) ( group F , n = 38 ) , or saline ( group S , n = 38 ) just before the end of anesthesia .


Emergence agitation scores were assessed .


Postoperative pain scores , awakening and extubation times , and the incidence of adverse effects were recorded .


Emergence agitation scores , the incidence of emergence agitation and severe emergence agitation were significantly lower in groups D and F than in group S ( p = 0.021 , p = 0.018 , and p = 0.028 , respectively ) .


The postoperative pain scores were lower in groups D and F as compared to group S ( p = 0.01 ) .


Awakening and extubation times in groups D and F were longer than that of group S ( p = 0.001 and p = 0.000 , respectively ) .


The overall incidence of postoperative complications was higher in group F compared to that in groups D and S ( p = 0.01 ) .


In children undergoing adenotonsillectomy under sevoflurane anesthesia , a single IV injection of dezocine 0.1 mgxkg ( -1 ) and fentanyl 1 gkg ( -1 ) were comparable in decreasing the incidence and severity of emergence agitation .


However , the use of dezocine was associated with a lower incidence of postoperative side effects .


Crohn 's disease-related inflammation is characterized by reduced activity of the immunosuppressive cytokine transforming growth factor 1 ( TGF-1 ) due to high levels of SMAD7 , an inhibitor of TGF-1 signaling .


Preclinical studies and a phase 1 study have shown that an oral SMAD7 antisense oligonucleotide , mongersen , targets ileal and colonic SMAD7 .


In a double-blind , placebo-controlled , phase 2 trial , we evaluated the efficacy of mongersen for the treatment of persons with active Crohn 's disease .


Patients were randomly assigned to receive 10 , 40 , or 160 mg of mongersen or placebo per day for 2 weeks .


The primary outcomes were clinical remission at day 15 , defined as a Crohn 's Disease Activity Index ( CDAI ) score of less than 150 , with maintenance of remission for at least 2 weeks , and the safety of mongersen treatment .


A secondary outcome was clinical response ( defined as a reduction of 100 points or more in the CDAI score ) at day 28 .


The proportions of patients who reached the primary end point were 55 % and 65 % for the 40-mg and 160-mg mongersen groups , respectively , as compared with 10 % for the placebo group ( P < 0.001 ) .


There was no significant difference in the percentage of participants reaching clinical remission between the 10-mg group ( 12 % ) and the placebo group .


The rate of clinical response was significantly greater among patients receiving 10 mg ( 37 % ) , 40 mg ( 58 % ) , or 160 mg ( 72 % ) of mongersen than among those receiving placebo ( 17 % ) ( P = 0.04 , P < 0.001 , and P < 0.001 , respectively ) .


Most adverse events were related to complications and symptoms of Crohn 's disease .


We found that study participants with Crohn 's disease who received mongersen had significantly higher rates of remission and clinical response than those who received placebo .


( Funded by Giuliani ; EudraCT number , 2011-002640-27 . )


To compare efficacy differences between fire filiform needle combined with mild moxibustion and gabapentin combined with sham acupuncture for postherpetic neuralgia ( PHN ) .


One hundred cases of PHN were randomly divided into a needle group and a medicine group , 50 cases in each one .


In the needle group , pricking method of fire filiform needle was given at the Ashi points , and then mild moxibustion was applied for 15 min .


In the medicine group , the oral administration of gabapentin capsule and sham acupuncture at non-acupoints in the distal end of lesions were applied .


The treatment was required for 21 days in both groups .


The visual analogue score ( VAS ) was recorded before treatment and on the 1st day , 2nd day , 3rd day , 6th day , 9th day and 12th day of treatment .


The most severity of pain within last 24 h , preset severity of pain , immediate analgesia effect and starting time of pain relief were observed , also the efficacy was assessed and improvement of symptoms was observed in the follow-up visit .


The total effective rate was 94.0 % ( 47/50 ) in the fire filiform needle group , which was superior to 86.0 % ( 43/50 ) in the medicine group ( P < 0.05 ) .


Compared with medicine group , the VAS of the most severity of pain within last 24 h was obviously reduced after the 2nd treatment in the fire filiform needle group while that of present severity of pain was relieved after the 1st treatment ( both P < 0.05 ) .


The immediate analgesia effect in the fire filiform needle group was obviously superior to that in the medicine group in the first three times of treatment ( all P < 0.05 ) .


The average time of pain relief was ( 3.91 + / - 0.82 ) days in the fire filiform needle group , which was significantly earlier to ( 6.53 + / - 1.13 ) days in the medicine group ( P < 0.05 ) .


26 cases were cured in the fire filiform needle group in the follow-up visit , which was superior to 2 cases in the medicine group ( P < 0.05 ) .


The improvement of VAS , pain range and sleep quality in the needle group were also superior to those in the medicine group ( all P < 0.05 ) .


The direct medical cost in the fire filiform needle group was ( 232.32 + / - 48.108 ) yuan , which was significantly lower than ( 466.00 + / - 41.09 ) yuan in the medicine group ( P < 0.05 ) .


There was only one case of adverse effect in the medicine group during the treatment .


The fire filiform needle combined with mild moxibustion could obviously relieve the pain in PHN patients , which has superior immediate analgesia effect and pain relieving time compared with gabapentin , which also has less adverse effects and cheap cost .


In this study , we evaluated the clinical relevance of serum drug levels and antidrug antibodies ( ADAbs ) with regard to response to treatment , as well as to relapse upon treatment discontinuation , in peripheral spondyloarthritis ( pSpA ) patients treated with adalimumab .


The study included 26 pSpA patients treated with adalimumab for either 12 weeks ( n = 12 ) or 24 weeks ( n = 14 ) in a randomized controlled trial .


Patients achieving inactive disease measured by Ankylosing Spondylitis Disease Activity Score ( ASDAS ) at the end of the treatment period were classified as responders .


Clinical characteristics , serum trough adalimumab levels and ADAbs were assessed at the end of the treatment period and at follow-up ( upon relapse or , in absence of relapse , at 16 weeks after discontinuation ) .


Serum adalimumab levels measured 2 weeks after the last adalimumab administration ranged from < 0.002 to 23.0 g/ml , with a median of 11.5 g/ml .


These levels were associated with neither response to treatment or disease activity measurements at the end of treatment nor with the occurrence of relapse and time to relapse after discontinuation of treatment .


Antiadalimumab ADAbs were present in 23 % of the patients at end of treatment and in 35 % at follow-up after treatment discontinuation , indicating that ADAbs were masked by the presence of the drug in some patients .


However , ADAbs at the end of treatment and at follow-up were not different between responders and nonresponders and were not associated with relapse upon discontinuation of treatment .


There is no clear association between adalimumab serum levels or antiadalimumab ADAbs with clinical response to treatment or with relapse upon treatment discontinuation in pSpA .


Netherlands Trial Register ID : NTR1806 ( registered 7 May 2009 ) .


Individuals with gambling or substance-use disorders exhibit similar functional alterations in reward circuitry suggestive of a shared underlying vulnerability in addictive disorders .


Additional research into common and unique alterations in reward-processing in substance-related and non-substance-related addictions may identify neural factors that could be targeted in treatment development for these disorders .


To investigate contextual reward-processing in pathological gambling , a slot-machine fMRI task was performed by three groups ( with pathological gambling , cocaine dependence and neither disorder ; N = 24 each ) to determine the extent to which two groups with addictions ( non-substance-related and substance-related ) showed similarities and differences with respect to each other and a non-addicted group during anticipatory periods and following the delivery of winning , losing and ` near-miss ' outcomes .


Individuals with pathological gambling or cocaine dependence compared to those with neither disorder exhibited exaggerated anticipatory activity in mesolimbic and ventrocortical regions , with pathological-gambling participants displaying greater positive possible-reward anticipation and cocaine-dependent participants displaying more negative certain-loss anticipation .


Neither clinical sample exhibited medial frontal or striatal responses that were observed following near-miss outcomes in healthy comparison participants .


Alterations in anticipatory processing may be sensitive to the valence of rewards and content-disorder-specific .


Common and unique findings in pathological gambling and cocaine dependence with respect to anticipatory reward and near-miss loss processing suggest shared and unique elements that might be targeted through behavioral or pharmacological interventions in the treatment of addictions .


Oral isotretinoin ( ISO ) is the gold standard for severe nodular acne .


However , as some patients are unwilling or unable to take , or are intolerant to , ISO , other options are needed .


To compare efficacy and safety of oral ISO vs. doxycycline 200 mg plus adapalene 01 % / benzoyl peroxide 25 % gel ( D+A / BPO ) in severe nodular acne over 20 weeks .


This was a multicentre , randomized , controlled , noninferiority investigator-blinded study involving 266 subjects .


D+A / BPO showed a significantly earlier onset of action in reducing nodules , papules/pustules and total lesions at week 2 .


ISO was superior in reducing nodules ( 956 % vs. 887 % ) , papules/pustules ( 952 % vs. 796 % ) and total lesions ( 929 % vs. 782 % ; all P < 001 ) at week 20 .


Half as many subjects for D+A / BPO compared with ISO had treatment-related , medically relevant adverse events ( 33 events in 180 % of subjects vs. 73 in 338 % of subjects , respectively ) .


D+A / BPO was noninferior to ISO in the intent-to-treat population [ 95 % confidence interval ( CI ) -27 to 208 ( P = 013 ) ; 639 % vs. 549 % of subjects , respectively ] and per-protocol population [ 95 % CI 39-286 ( P = 001 ) ; 743 % vs. 58 % of subjects , respectively ) , based on the composite efficacy/safety end point .


D+A / BPO showed a favourable composite efficacy/safety profile compared with ISO .


This combination is an alternative to ISO in patients intolerant to , or unable or unwilling to take , oral ISO , and is an option for treatment of severe nodular acne .


We aimed to compare the performance of novices with three-dimensional ( 3D ) versus two-dimensional ( 2D ) laparoscopy using Fundamentals of Laparoscopic Surgery ( FLS ) tasks .


Fifty-six novices with no uncorrected visual problems were randomly allocated to 2D and 3D groups .


All candidates practiced FLS tasks on a box trainer until they achieved proficiency .


Their performance was assessed by considering completion time , number of repetitions , and number of errors following the validated FLS proficiency criteria .


Twenty-five participants in each group completed the training curriculum .


The median performance time ( in minutes ) for the 3D group was 216 , which was less than that of the 2D group of 247 min ( P = 0.266 ) .


The median numbers of repetitions and errors were lower for the 3D group versus the 2D group : 108 versus 121 ( P = 0.008 ) and 27 versus 105 ( P < 0.001 ) , respectively .


Stereoscopic vision improved accuracy in laparoscopic skills for novices , which was manifested in reduced numbers of repetitions and errors .


However , it does not affect the global performance time across all tasks .


Pro-inflammatory cytokines including tumor necrosis factor alpha ( TNF - ) , interleukin-1 ( IL-1 ) and interleukin-6 ( IL-6 ) play an important role in the development of hematopoietic stem cell transplantation ( HSCT ) complications .


We explored the effect of Selenium as an antioxidant and anti-inflammatory agent on pro-inflammatory cytokines levels in HSCT candidates .


Plasma concentrations of TNF - , IL-1 and IL-6 were measured in 74 patients from a double-blind , randomized , placebo-controlled study .


In both groups , there were 37 patients with median age of 32years .


Patients received oral Se tablets ( 200 mcg ) or placebo twice daily beginning from the first day of high dose chemotherapy ( HDC ) through 14days after HSCT .


Cytokine levels were determined before starting HDC ( prior to first dose of Se ) , 7 and 14days after HSCT .


Plasma levels of TNF - were not significantly different between Se and control group ( P = 0.13 ) .


IL-1 levels were similar between two groups ( P = 0.88 ) .


No significant differences were detected in IL-6 levels between Se and control group ( P = 0.96 ) .


Selenium had no effect on pro-inflammatory cytokines levels in patients undergoing HSCT .


It is likely that earlier initiation and/or larger doses of Se are required to affect inflammatory cytokines significantly .


Sleep deprivation may be particularly detrimental to intensive care unit ( ICU ) patients .


Polysomnography has demonstrated abnormal sleep in medical and surgical ICU populations .


Both environmental factors and circadian disruption have been implicated .


We hypothesized that patients in a neurologic ICU would demonstrate similar sleep disturbances and that a combination of sleep-promoting interventions would increase sleep time .


Twelve patients were enrolled in this pilot-randomized , controlled , study in a neurologic ICU .


For adult patients undergoing continuous EEG for clinical purposes , noise-cancelling headphones and eye masks were worn , and an oral dose of melatonin was administered for 3 days , or until EEG was stopped .


Sleep was scored according to standard criteria ; EEG was characterized and analyzed quantitatively .


Sixty-five percent of the patients ' recordings were unscorable based on accepted standardized criteria ; therefore , sleep measures could not be compared .


For those with sleep that could be scored , total sleep time was normal , although sleep was fragmented and time spent in slow-wave or rapid eye movement sleep was notably decreased .


Patients with unscorable recordings had worse injury severity measures , absent or significantly slower posterior dominant rhythm , and less coherence of posterior faster frequencies .


Clinical outcomes were similar between intervention and control groups .


Although sleep-promoting interventions were feasible , sleep quantification based on currently accepted criteria limited the ability to score sleep .


Similar to other ICUs , sleep in the neurologic ICU is abnormal ; patients with unscorable sleep-like states have greater injury severity .


This study was limited by strict enrollment criteria .


A reliable method to quantify sleep and sleep-like states in the ICU is needed .


Ultrasound ( US ) and low-level laser therapy ( LLLT ) are commonly employed for myofascial trigger points ( MTP ) despite lack of evidence for usage as stand-alone treatments .


The aim of the study was to determine , on MTP of the upper trapezius muscle ( uTM ) , the effects of US and LLLT per se , as delivered in accordance with the procedures reported by surveys about their usage among physiotherapists .


Design was set as a double-blind , randomized , placebo-controlled study .


Sixty participants with at least one active MTP in uTM ( 28 women and 32 men ; mean age 24.51.44 years ) were recruited and randomly assigned to one out of five groups : active US ( n = 12 ) , placebo US ( n = 12 ) , active LLLT ( n = 11 ) , placebo LLLT ( n = 11 ) and no therapy ( control , n = 14 ) .


The participants and outcome assessor were blinded to the group assignment and therapy delivered .


Three outcome measures were assessed at baseline , after a 2-week treatment and 12weeks after the end of the intervention ( follow-up ) : pressure pain threshold , subjective pain on a numerical rating scale and muscle extensibility performing a cervical lateral flexion .


All subjects assigned to the intervention groups were treated five times weekly for overall 10 treatments given .


Two-way ANOVA was used to compare differences before and after intervention and among groups at each time-point .


After the 2-week intervention , all groups showed pressure pain threshold , numerical rating scale and cervical lateral flexion significant improvements ( p < 0.05 ) , which were confirmed at the follow-up .


When performing multiple comparisons , controls scored significantly less than both the active therapies and placebos , whereas no differences were detected between active therapies and placebos .