Craving was measured using the : ( 1 ) Desires for Drug Questionnaire ( DDQ ) and ( 2 ) Penn Alcohol-Craving Scale adapted for opioid craving ( PCS ) .


Multi-level logistic regression models estimated the effects of craving on the likelihood of opioid use .


Craving assessed at time t was entered as a time-varying predictor of opioid use at time t +1 .


Craving scores plateaued at approximately 2 weeks after initiation of buprenorphine .


In adjusted regression models , a 1-point increase in PCS scores ( on a 7-point scale ) was associated with a significant increase in the odds of opioid use at the subsequent assessment ( OR = 1.27 , 95 % CI 1.08 ; 1.49 , p < 0.01 ) .


The odds of opioid use at the subsequent follow-up assessment increased significantly as DDQ desire and intention scores increased ( OR = 1.25 , 95 % CI 1.03 ; 1.51 , p < 0.05 ) , but was not significantly associated with DDQ negative reinforcement ( OR = 1.01 , 95 % CI 0.88 ; 1.17 , p > 0.05 ) or DDQ control ( OR = 0.97 , 95 % CI 0.85 ; 1.11 , p > 0.05 ) scores .


Self-reported craving for opioids was modestly associated with subsequent relapse to opioid use among a cohort of patients treated with buprenorphine .


Assessment of craving may provide clinical utility in predicting relapse among treated opioid-dependent patients .


Neurotoxic metabolites and oxidative and nitrosative stress reactions play a crucial role in the pathways leading to neuronal cell death and neurodegeneration .


The bioavailability of the many antioxidant ingredients a vitamin and trace element composition was investigated , to reveal the neuroprotective ( preventive ) potential of the composition .


We recruited 159 healthy volunteers , assigned them randomly and double blind to a placebo and verum group .


Physicians excluded volunteers with severe chronic diseases or interfeering medications .


142 participants finished the six month trial .


Laboratory parameters were determined 1 ) before participation , and 2 ) after three and 3 ) six months .


We confirmed the bioavailability of ingredients , and determined metabolic parameters associated with the integrity of the blood brain barrier , mitochondrial deficiency ( Q 10 ) , neurodegeneration ( homocystein ) , and antioxidative capacity ( e.g. lipidperoxidation ) , and superoxiddismutase activity .


Starting from baseleine , after three months neuroprotective ingredients increased within their physiological borders , folic acid ( p < 0.003 ) , pyridoxin ( p < 0.001 ) , cobalamin ( p = 0.001 ) , and the fat soluble vitamin tocopherol ( p < 0.001 ) .


In parallel , homocytein decreased after 3 and 6 months ( p < 0.001 , and p < 0.025 , respectively ) .


Other paramters like zinc reacted slower , significant changes were observed only after 6 months .


The observed metabolic changes and alteration of the oxidative status after 3 and six month of regular intake underlines the compositions ' potential to ameliorate neurodegenerative processes .


We conclude that the subsitution of vitamins and trace-elements with natural source in a proper manner may be effective for neuroprotection in healthy population .


Weakness in knee flexion following anterior cruciate ligament ( ACL ) reconstruction is one of the key issues in the treatment of an ACL tear .


The purpose of this study was to examine and compare clinical outcome measures of ACL reconstruction using semitendinosus autograft ( ST ) versus semitendinosus + gracilis ( ST/G ) reconstructive techniques .


In a double-blind randomized clinical study , 19 patients with an ACL tear underwent either ST ( 59 ) or ST/G ( 61 ) and observed for 1year .


Both patients and the final examiner were unaware as to the type of graft received .


Patients were evaluated according to subjective criteria , functional assessment tests , knee isometric torques , knee laxity using KT-2000 and knee range of motion .


The study included 21 ( 17.6 % ) female and 99 ( 82.4 % ) male patients with a mean age of 29.97.8 in the ST group and 32.46.3 in the ST/G group .


There were no significant differences found in surgical complications ; IKD ; Knee injury and Osteoarthritis Outcome Score ; Lysholm ; strength of the knee isometric flexors ; and flexion and extension loss between the two groups .


At the final visit , 86.9 % of ST group and 89.6 % of ST/G group had side-to-side difference of laxity < 3mm ( n.s. ) .


Since anterior cruciate ligament reconstruction using quadrupled ST is more technically demanding than doubled STG and with there being no difference in outcomes and complications , no compulsory advice should be made on the former technique .


However , gracilis harvesting may not be necessary based on the function and strength of the knee .


Randomized controlled trial , Level I.


To evaluate whether wearing a wool cap , a routine practice used to prevent heat loss in premature infants , affects interpretation of electroencephalogram spectral analysis .


Eighteen premature infants ( median gestational age 28 weeks , range 23-32 ) without neurological complications were randomized to two channel ( C3 , C4 referred to Cz ) digital electroencephalogram recordings with ( 90 min ) and without ( 90 min ) wearing wool cap , at 4 days of life .


Electroencephalogram was analyzed automatically by measurement of burst suppression ratio and asymmetry index and by Fast Fourier Transform to calculate total absolute spectral power ; relative spectral power in the ( 0.5-3 .5 Hz ) , ( 4-7 .5 Hz ) , ( 8-12 .5 Hz ) , and ( 13-30 Hz ) frequency bands ; spectral edge frequency ; and mean dominant frequency .


The use of wool cap had no effect on all electroencephalogram parameters considered .


Gestational age showed an effect on relative spectral power of all considered bands , spectral edge frequency and mean dominant frequency , while no effect was seen on burst suppression ratio and asymmetry index .


Neonates born at gestational weeks lower than 28 had significantly higher relative power in the band and lower relative power in the and bands .


Heat loss prevention using wool cap does not affect interpretation of spectral electroencephalogram .


Spectral values in our group of very premature infants without neurological complications correspond to normal data reported in the literature .


Maturation changes consist of reduction of relative power of the band , spectral edge frequency and mean dominant frequency .


There is a high prevalence of smoking and high burden of tobacco-related diseases among low-income populations .


Effective , evidenced-based smoking cessation treatments are available , but low-income smokers are less likely than higher-income smokers to use these treatments , especially the most comprehensive forms that include a combination of pharmacotherapy and intensive behavioral counseling .


The primary objectives of this randomized controlled trial are to compare the effects of a proactive tobacco treatment intervention compared to usual care on population-level smoking abstinence rates and tobacco treatment utilization rates among a diverse population of low-income smokers , and to determine the cost-effectiveness of proactive tobacco treatment intervention .


The proactive care intervention systematically offers low-income smokers free and easy access to evidence-based treatments and has two primary components : ( 1 ) proactive outreach to current smokers in the form of mailed invitation materials and telephone calls containing targeted health messages , and ( 2 ) facilitated access to free , comprehensive , evidence-based tobacco cessation treatments in the form of NRT and intensive , telephone-based behavioral counseling .


The study aims to include a population-based sample ( N = 2500 ) of adult smokers enrolled in the Minnesota Health Care Programs ( MHCP ) , a state-funded health insurance plan for low-income persons .


Baseline data is obtained from MHCP administrative databases and a participant survey that is conducted prior to randomization .


Outcome data is collected from a follow-up survey conducted 12months after randomization and MHCP administrative data .


The primary outcome is six-month prolonged smoking abstinence at one year and is assessed at the population level .


All randomized individuals are asked to complete the follow-up survey , regardless of whether they participated in tobacco treatment .


Data analysis of the primary aims will follow intent-to-treat methodology .


There is a critical need to increase access to effective tobacco dependence treatments .


This randomized trial evaluates the effects of proactive outreach coupled with free NRT and telephone counseling on the population impact of tobacco dependence treatment .


If proven to be effective and cost-effective , national dissemination of proactive treatment approaches would reduce tobacco-related morbidity , mortality , and health care costs for low income Americans .


ClinicalTrials.gov : NCT01123967 .


Angina affects more than 50 million people worldwide .


Secondary prevention interventions such as cardiac rehabilitation are not widely available for this population .


An Internet-based version could offer a feasible alternative .


Our aim was to examine the effectiveness of a Web-based cardiac rehabilitation program for those with angina .


We conducted a randomized controlled trial , recruiting those diagnosed with angina from general practitioners ( GPs ) in primary care to an intervention or control group .


Intervention group participants were offered a 6-week Web-based rehabilitation program ( `` ActivateYourHeart '' ) .


The program was introduced during a face-to-face appointment and then delivered via the Internet ( no further face-to-face contact ) .


The program contained information about the secondary prevention of coronary heart disease ( CHD ) and set each user goals around physical activity , diet , managing emotions , and smoking .


Performance against goals was reviewed throughout the program and goals were then reset/modified .


Participants completed an online exercise diary and communicated with rehabilitation specialists through an email link/synchronized chat room .


Participants in the control group continued with GP treatment as usual , which consisted of being placed on a CHD register and attending an annual review .


Outcomes were measured at 6-week and 6-month follow-ups during face-to-face assessments .


The primary outcome measure was change in daily steps at 6 weeks , measured using an accelerometer .


Secondary outcome measures were energy expenditure ( EE ) , duration of sedentary activity ( DSA ) , duration of moderate activity ( DMA ) , weight , diastolic/systolic blood pressure , and body fat percentage .


Self-assessed questionnaire outcomes included fat/fiber intake , anxiety/depression , self-efficacy , and quality of life ( QOL ) .


A total of 94 participants were recruited and randomized to the intervention ( n = 48 ) or the usual care ( n = 46 ) group ; 84 and 73 participants completed the 6-week and 6-month follow-ups , respectively .


The mean number of log-ins to the program was 18.68 ( SD 13.13 , range 1-51 ) , an average of 3 log-ins per week per participant .


Change in daily steps walked at the 6-week follow-up was +497 ( SD 2171 ) in the intervention group and -861 ( SD 2534 ) in the control group ( 95 % CI 263-2451 , P = .02 ) .


Significant intervention effects were observed at the 6-week follow-up in EE ( +43.94 kcal , 95 % CI 43.93-309 .98 , P = .01 ) , DSA ( -7.79 minutes , 95 % CI -55.01 to -7.01 , P = .01 ) , DMA ( +6.31 minutes , 95 % CI 6.01-51 .20 , P = .01 ) , weight ( -0.56 kg , 95 % CI -1.78 to -0.15 , P = .02 ) , self-efficacy ( 95 % CI 0.30-4 .79 , P = .03 ) , emotional QOL score ( 95 % CI 0.01-0 .54 , P = .04 ) , and angina frequency ( 95 % CI 8.57-35 .05 , P = .002 ) .


Significant benefits in angina frequency ( 95 % CI 1.89-29 .41 , P = .02 ) and social QOL score ( 95 % CI 0.05-0 .54 , P = .02 ) were also observed at the 6-month follow-up .


An Internet-based secondary prevention intervention could be offered to those with angina .


A larger pragmatic trial is required to provide definitive evidence of effectiveness and cost-effectiveness .


International Standard Randomized Controlled Trial Number ( ISRCTN ) : 90110503 ; http://www.controlled-trials.com/ISRCTN90110503/ISRCTN90110503 ( Archived by WebCite at http://www.webcitation.org/6RYVOQFKM ) .


To compare the clinical efficacy of olive oil and the Saj ( ) cream on the occurrence and severity of striae gravidarum .


Parallel randomized controlled clinical trial .


West Health Centre , Lolagar and Akbarabadi Hospitals , Tehran , Iran .


360 Nulliparous women at their second trimester of pregnancy randomly ( simple randomization ) allocated into three groups of olive oil , the Saj ( ) cream , and control that finally 150 of them ( 50 subjects in each group ) completed the study .


Control group did not receive any medication/intervention .


At gestational age of 38-40 weeks the participants were evaluated regarding the occurrence of striae on abdominal skin and its severity that were primary outcome of the study .


In the olive oil group , striae occurred in 72 % of the participants , which were mild , moderate , and severe in 32 % , 26 % , and 6 % of the cases , respectively .


In those who received Saj ( ) cream , striae occurred in 64 % of the cases , which were mild , moderate and severe in 16 % , 34 % , and 14 % of the cases , respectively .


With regard to the control group , striae occurred in 60 % of the participants , among which striae were mild , moderate , and severe in 22 % , 24 % , and 14 % of the cases , respectively .


There were no statistically significant differences among the three studied groups regarding the incidence or severity of striae .


Neither olive oil nor the Saj ( ) cream were effective in preventing the occurrence of striae gravidarum or affecting its severity .


Further studies to examine the effect of other herbal/chemical preparations on occurrence of striae gravidarum are recommended .


Elevated soluble CD40 ligand ( sCD40L ) was shown to be related to cardiovascular events , but the role of sCD40L in predicting recurrent stroke remains unclear .


Baseline sCD40L levels were measured in 3044 consecutive patients with acute minor stroke and transient ischemic attack , who had previously been enrolled in the Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events ( CHANCE ) trial .


Cox proportional-hazards model was used to assess the association of sCD40L with recurrent stroke .


Patients in the top tertile of sCD40L levels had increased risk of recurrent stroke comparing with those in the bottom tertile , after adjusted for conventional confounding factors ( hazard ratio , 1.49 ; 95 % confidence interval , 1.11-2 .00 ; P = 0.008 ) .


The patients with elevated levels of both sCD40L and high-sensitive C-reactive protein also had increased risk of recurrent stroke ( hazard ratio , 1.81 ; 95 % confidence interval , 1.23-2 .68 ; P = 0.003 ) .


Elevated sCD40L levels independently predict recurrent stroke in patients with minor stroke and transient ischemic attack .


URL : http://www.clinicaltrials.gov .


Unique identifier : NCT00979589 .


Microglia have been associated with inflammatory changes underlying diabetic retinopathy .


To investigate whether low-dose oral doxycycline monohydrate , a drug capable of inhibiting microglial activation , can improve or slow the deterioration of retinal function and whether it can induce regression or slow progression of diabetic retinopathy in patients with mild to moderate nonproliferative diabetic retinopathy ( NPDR ) .


Randomized , double-masked , 24-month proof-of-concept clinical trial .


We randomized 33 patients ( from the Penn State Hershey Eye Center ) with at least 1 eye with mild to moderate NPDR ( Early Treatment Diabetic Retinopathy Study level 20-43 ) to doxycycline monohydrate , 50 mg/d , or daily placebo for 24 months .


Mean change at 24 months compared with baseline in the foveal sensitivity of matrix frequency-doubling perimetry in each treatment group .


We also compared the 2 groups with respect to change from baseline to 24 months in functional variables ( Humphrey photopic visual field testing using the Swedish interactive thresholding algorithm 24-2 strategy , contrast sensitivity , dark adaptation , visual acuity , and quality of life ) and anatomical variables ( diabetic retinopathy severity level , area of retinal thickening , central subfield thickness on optical coherence tomography , and macular volume on optical coherence tomography ) .


From baseline to month 24 , no significant difference was detected between groups with respect to all visual function and anatomical outcomes assessed .


Although a link between low-dose oral anti-inflammatory agents and subclinical improvement in inner retinal function has been suggested in patients with severe NPDR or non-high-risk proliferative diabetic retinopathy , the same association was not found in the present study of patients with mild to moderate NPDR .


The different findings in the 2 patient populations may relate to a differential effect of doxycycline on different stages of diabetic retinal dysfunction , or the sample size of the present study may be too small to detect a treatment effect of doxycycline in patients with mild to moderate NPDR .


clinicaltrials.gov Identifier : NCT00917553 .


To investigate the acute residual hormonal and neuromuscular responses exhibited following a single session of mechanical vibration applied to the upper extremities among different acceleration loads .


Thirty male students were randomly assigned to a high vibration group ( HVG ) , a low vibration group ( LVG ) , or a control group ( CG ) .


A randomized double-blind , controlled-parallel study design was employed .


The measurements and interventions were performed at the Laboratory of Biomechanics of the University of L'Aquila .


The HVG and LVG participants were exposed to a series of 20 trials 10 s of synchronous whole-body vibration ( WBV ) with a 10-s pause between each trial and a 4-min pause after the first 10 trials .


The CG participants assumed an isometric push-up position without WBV .


The outcome measures were growth hormone ( GH ) , testosterone , maximal voluntary isometric contraction during bench-press , maximal voluntary isometric contraction during handgrip , and electromyography root-mean-square ( EMGrms ) muscle activity ( pectoralis major [ PM ] , triceps brachii [ TB ] , anterior deltoid [ DE ] , and flexor carpi radialis [ FCR ] ) .


The GH increased significantly over time only in the HVG ( P = 0.003 ) .


Additionally , the testosterone levels changed significantly over time in the LVG ( P = 0.011 ) and the HVG ( P = 0.001 ) .


MVC during bench press decreased significantly in the LVG ( P = 0.001 ) and the HVG ( P = 0.002 ) .


In the HVG , the EMGrms decreased significantly in the TB ( P = 0.006 ) muscle .


In the LVG , the EMGrms decreased significantly in the DE ( P = 0.009 ) and FCR ( P = 0.006 ) muscles .


Synchronous WBV acutely increased GH and testosterone serum concentrations and decreased the MVC and their respective maximal EMGrms activities , which indicated a possible central fatigue effect .


Interestingly , only the GH response was dependent on the acceleration with respect to the subjects ' responsiveness .


The purpose of this study was to assess long-term safety and tolerability of desvenlafaxine ( administered as desvenlafaxine succinate ) in children and adolescents with major depressive disorder ( MDD ) .


An 8 week , multicenter , open-label , fixed-dose study of children ( ages 7-11 years ) and adolescents ( ages 12-17 years ) with MDD was followed by a 6 month , flexible-dose extension study .


Patients were administered desvenlafaxine 10-100mg / day ( children ) or 25-200mg / day ( adolescents ) for a total of 8 months .


Treatment-emergent adverse events ( AEs ) , withdrawals because of AEs , laboratory tests , vital signs , and the Columbia Suicide-Severity Rating Scale ( C-SSRS ) were collected .


Eight month safety results from the lead-in plus extension studies are reported for extension study participants , using lead-in study day -1 as baseline .


Forty patients were enrolled in both studies ( 20 children ; 20 adolescents ) .


Of those , four children and three adolescents withdrew because of AEs .


Treatment-emergent AEs reported by three or more patients were upper abdominal pain ( 15 % ) and headache ( 15 % ) in children , and somnolence ( 30 % ) , nausea ( 20 % ) , upper abdominal pain ( 15 % ) , and headache ( 15 % ) in adolescents .


Negativism ( oppositional behavior ) in a child was the single serious AE reported .


No deaths occurred during the lead-in or extension studies .


Mean pulse rates demonstrated statistically significant increases from lead-in study baseline to final evaluation ( children , +5.2 bpm ; adolescents , +5.9 bpm ; p0 .05 ) .


No statistically significant change in blood pressure was observed at final evaluation .


Two adolescents ( 0 children ) reported suicidal ideation on the C-SSRS at screening assessment and during the lead-in and/or extension trials ; one adolescent reported suicidal ideation after screening only .


Long-term ( 8 month ) treatment with desvenlafaxine was generally safe and well tolerated in depressed children and adolescents .


To evaluate the effect of a programme of active self-correction and task-oriented exercises on spinal deformities and health-related quality of life ( HRQL ) in patients with mild adolescent idiopathic scoliosis ( AIS ) ( Cobb angle < 25 ) .


This was a parallel-group , randomised , superiority-controlled study in which 110 patients were randomly assigned to a rehabilitation programme consisting of active self-correction , task-oriented spinal exercises and education ( experimental group , 55 subjects ) or traditional spinal exercises ( control group , 55 subjects ) .


Before treatment , at the end of treatment ( analysis at skeletal maturity ) , and 12 months later ( follow-up ) , all of the patients underwent radiological deformity ( Cobb angle ) , surface deformity ( angle of trunk rotation ) and HRQL evaluations ( SRS-22 questionnaire ) .


A linear mixed model for repeated measures was used for each outcome measure .


There were main effects of time ( p < 0.001 ) , group ( p < 0.001 ) and time by group interaction ( p < 0.001 ) on radiological deformity : training in the experimental group led to a significant improvement ( decrease in Cobb angle of > 5 ) , whereas the control group remained stable .


Analysis of all of the secondary outcome measures revealed significant effects of time , group and time by group interaction in favour of the experimental group .


The programme of active self-correction and task-oriented exercises was superior to traditional exercises in reducing spinal deformities and enhancing the HRQL in patients with mild AIS .


The effects lasted for at least 1 year after the intervention ended .


To evaluate the effect of intraoperative acupuncture on posttonsillectomy pain in the pediatric population .


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


Patients aged 3 to 12 years undergoing tonsillectomy were recruited at a tertiary children 's hospital between February 2011 and May 2012 .


Participants were block-randomized to receive acupuncture or sham acupuncture during anesthesia for tonsillectomy .


Surgeons , staff , and parents were blinded from treatment .


Tonsillectomy was performed by one of two surgeons using a standard technique ( monopolar cautery ) , and a single anesthetic protocol was followed .


Study endpoints included time spent in the postanesthesia care unit , the amount of opioids administered in the perioperative period , and pain measures and presence of nausea/vomiting from postoperative home surveys .


Fifty-nine children aged 3 to 12 years were randomized to receive acupuncture ( n = 30 ) or sham acupuncture ( n = 29 ) .


No significant demographic differences were noted between the two cohorts .


Perioperative data were recorded for all patients ; 73 % of patients later returned home surveys .


There were no significant differences in the amount of opioid medications administered or total postanesthesia care unit time between the two cohorts .


Home surveys of patients but not of parents revealed significant improvements in pain control in the acupuncture treatment-group postoperatively ( P = 0.0065 and 0.051 , respectively ) , and oral intake improved significantly earlier in the acupuncture treatment group ( P = 0.01 ) .


No adverse effects of acupuncture were reported .


This study demonstrates that intraoperative acupuncture is feasible , well tolerated , and results in improved pain and earlier return of diet postoperatively .


1b .


Results supporting the use and the effectiveness of positive expiratory , pressure devices in chronic obstructive pulmonary disease ( COPD ) patients are still controversial , We have tested the hypothesis that adding TPEP or IPPB to standard pharmacological therapy may provide additional clinical benefit over , pharmacological therapy only in patients with severe COPD .


Fourty-five patients were randomized in three groups : a group was treated ; with IPPB , a group was treated with TPEP and a group with pharmacological ; therapy alone ( control group ) .


Primary outcome measures included the measurement of scale or , questionnaire concerning dyspnea ( MRC scale ) , dyspnea , cough , and , sputum ( BCSS ) and quality of life ( COPD assessment test ) ( CAT ) .


Secondary , outcome measures were respiratory function testing , arterial blood gas , analysis , and hematological examinations .


Both patients in the IPPB group and in the TPEP group showed a significant , improvement in two of three tests ( MRC , CAT ) compared to the control , group.However , in the group comparison analysis for , the same variables between IPPB group and TPEP group we observed a , significant improvement in the IPPB group ( P. 05 for MRC and P. 01 for , CAT ) .


The difference of action of the two techniques are evident in the results of , pulmonary function testing : IPPB increases FVC , FEV1 , and MIP ; this reflects , its capacity to increase lung volume .


Also TPEP increases FVC and FEV1 ( less , than IPPB ) , but increases MEP , while decreasing total lung capacity and , residual volume .


The two techniques ( IPPB and TPEP ) improves significantly dyspnea ; quality of ; life tools and lung function in patients with severe COPD .


IPPB demonstrated a greater effectiveness to improve dyspnea and quality of life tools ( MRC , CAT ) than TPEP .


Data from randomized trials are lacking on the benefits and risks of initiating antiretroviral therapy in patients with asymptomatic human immunodeficiency virus ( HIV ) infection who have a CD4 + count of more than 350 cells per cubic millimeter .


We randomly assigned HIV-positive adults who had a CD4 + count of more than 500 cells per cubic millimeter to start antiretroviral therapy immediately ( immediate-initiation group ) or to defer it until the CD4 + count decreased to 350 cells per cubic millimeter or until the development of the acquired immunodeficiency syndrome ( AIDS ) or another condition that dictated the use of antiretroviral therapy ( deferred-initiation group ) .


The primary composite end point was any serious AIDS-related event , serious non-AIDS-related event , or death from any cause .


A total of 4685 patients were followed for a mean of 3.0 years .


At study entry , the median HIV viral load was 12,759 copies per milliliter , and the median CD4 + count was 651 cells per cubic millimeter .


On May 15 , 2015 , on the basis of an interim analysis , the data and safety monitoring board determined that the study question had been answered and recommended that patients in the deferred-initiation group be offered antiretroviral therapy .


The primary end point occurred in 42 patients in the immediate-initiation group ( 1.8 % ; 0.60 events per 100 person-years ) , as compared with 96 patients in the deferred-initiation group ( 4.1 % ; 1.38 events per 100 person-years ) , for a hazard ratio of 0.43 ( 95 % confidence interval [ CI ] , 0.30 to 0.62 ; P < 0.001 ) .


Hazard ratios for serious AIDS-related and serious non-AIDS-related events were 0.28 ( 95 % CI , 0.15 to 0.50 ; P < 0.001 ) and 0.61 ( 95 % CI , 0.38 to 0.97 ; P = 0.04 ) , respectively .


More than two thirds of the primary end points ( 68 % ) occurred in patients with a CD4 + count of more than 500 cells per cubic millimeter .


The risks of a grade 4 event were similar in the two groups , as were the risks of unscheduled hospital admissions .


The initiation of antiretroviral therapy in HIV-positive adults with a CD4 + count of more than 500 cells per cubic millimeter provided net benefits over starting such therapy in patients after the CD4 + count had declined to 350 cells per cubic millimeter .


( Funded by the National Institute of Allergy and Infectious Diseases and others ; START ClinicalTrials.gov number , NCT00867048 . )


Weight gain during the childbearing years and failure to lose pregnancy weight after birth contribute to the development of obesity in postpartum Latinas .


Madres para la Salud [ Mothers for Health ] was a 12-month , randomized controlled trial exploring a social support intervention with moderate-intensity physical activity ( PA ) seeking to effect changes in body fat , fat tissue inflammation , and depression symptoms in sedentary postpartum Latinas .


This report describes the efficacy of the Madres intervention .


The results show that while social support increased during the active intervention delivery , it declined to pre-intervention levels by the end of the intervention .


There were significant achievements in aerobic and total steps across the 12months of the intervention , and declines in body adiposity assessed with bioelectric impedance .


Social support from family and friends mediated increases in aerobic PA resulting in decrease in percent body fat .


ClinicalTrials.gov Identifier : NCT01908959 .


We sought to investigate the relationship between the SYNTAX score ( SS ) and stent thrombosis ( ST ) in patients with non-ST-segment elevation acute coronary syndromes ( NSTE-ACS ) undergoing percutaneous coronary intervention ( PCI ) .


The relationship between the SS and ST is undetermined .


We stratified 2,627 patients undergoing PCI in the ACUITY trial by SS tertile according to the current population ( true tertiles , SS < 7 , SS = 7-12 , and SS > 12 ) and by the SYNTAX trial ( original SYNTAX tertiles , SS < 23 , SS = 23-32 , and SS > 32 ) .


Thirty-day and 1-year rates of definite/probable ST were determined for each tertile .


A total 30 ( 1.1 % ) and 41 ( 1.6 % ) definite/probable ST events occurred by 30 days and 1 year , respectively .


When stratified by true tertiles , 30-day and 1-year rates of definite/probable ST were significantly greater in the highest tertile ( SS > 12 ; 2.0 % and 2.8 % ) compared with the intermediate ( SS = 7-12 ; 0.7 % and 1.1 % ) and lowest tertiles ( SS < 7 ; 0.6 % and 0.7 % ) , P = 0.007 and P = 0.0009 , respectively .


When stratified by original SYNTAX tertiles , 30-day and 1-year rates of definite/probable ST were significantly greater in the highest ( SS > 32 ; 6.3 % and 8.8 % ) and intermediate tertiles ( SS = 23-32 ; 2.8 % and 3.7 % ) compared with the lowest tertile ( SS < 22 ; 0.8 % and 1.2 % ) , P < 0.0001 for both .


By multivariable analysis , the SS was an independent predictor for both 30-day and 1-year definite/probable ST.


In patients with NSTE-ACS undergoing PCI , the extent and severity of CAD , as assessed by the SS before revascularization , was strongly associated with the occurrence of ST both at 30 days and 1 year .


2014 Wiley Periodicals , Inc. .


This study sought to identify the incidence , predictors , and prognostic impact of bleeding complications ( BC ) after surgical aortic valve replacement ( SAVR ) compared with transcatheter aortic valve replacement ( TAVR ) .


Bleeding complications after SAVR and TAVR are frequent and may be associated with an unfavorable prognosis .


In the randomized controlled PARTNER ( Placement of Aortic Transcatheter Valve ) I trial , 657 patients from cohort A ( operable high risk ) were randomly assigned to SAVR or TAVR ( transfemoral [ TF ] if iliofemoral access was suitable or transapical [ TA ] if not ) and received the designated treatment .


First-generation Edwards SAPIEN valves and delivery systems ( Edwards Lifesciences , Irvine , California ) were used for TAVR , through a 22 - or 24-F sheath .


The 30-day rates of major BC ( modified Valve Academic Research Consortium definitions ) , predictors of BC , and their association with 1-year mortality were assessed .


A total of 71 ( 22.7 % ) , 27 ( 11.3 % ) , and 9 ( 8.8 % ) patients had major BC within 30 days of the procedure after SAVR , TF-TAVR , and TA-TAVR , respectively ( p < 0.0001 ) .


SAVR was associated with a significantly higher 30-day rate of transfusion ( 17.9 % ) than either TF-TAVR ( 7.1 % ) or TA-TAVR ( 4.8 % ; p < 0.0001 ) .


Independent predictors of major BC were the occurrence of major vascular complications and use of intraprocedural hemodynamic support among TF-TAVR patients , severe procedural complications requiring conversion to open surgery among TA-TAVR patients , and the presence of low hemoglobin at baseline among SAVR patients .


Major BC was identified as the strongest independent predictor of 1-year mortality among the full cohort .


However , risk-adjusted analyses demonstrated a significant interaction between BC and treatment strategy with respect to mortality , suggesting that BC after SAVR have a greater impact on prognosis than after TAVR .


Among high-risk aortic stenosis patients enrolled in the PARTNER I randomized trial , BC were more common after SAVR than after TAVR and were also associated with a worse long-term prognosis .


( THE PARTNER TRIAL : Placement of AoRTic TraNscathetER Valve Trial ; NCT00530894 ) .


Abuse of opioid analgesics has become a public health issue .


Some opioid abusers use intravenous administration to increase the magnitude of positive reinforcing effects .


Intravenous co-administration of oxycodone with naloxone , an opioid antagonist , may reduce these rewarding effects and discourage abuse .


A 2:1 oxycodone : naloxone ( OXN ) tablet formulation has been studied in the USA for the management of moderate-to-severe chronic pain .


Intravenous administration of a 2:1 oxycodone : naloxone solution ( sOXN ) reflects the oxycodone : naloxone ratio found in laboratory studies of OXN following tampering for intravenous administration .


The objective of this study was to characterize abuse-deterrent properties of sOXN .


This single-center , double-blind , randomized , placebo-controlled , active-controlled , crossover study enrolled nondependent recreational opioid users with experience using multiple ( two or more ) routes of administration .


Following demonstration that subjects could discern between placebo and oxycodone , 24 eligible male and female subjects were randomized to receive intravenous injections of 0.07 mg/kg oxycodone ( OXY ) , 0.07 mg/kg oxycodone and 0.035 mg/kg naloxone solution ( sOXN ) , or matching placebo over three visits .


Pharmacokinetics , pharmacodynamics , safety , and tolerability were assessed at scheduled times up to 8h post-dose .


Parameters were computed and statistically compared among treatments .


Pharmacokinetics were similar between OXY and sOXN .


Subjects reported significantly fewer rewarding effects with sOXN compared with OXY ; differences between sOXN and placebo were generally not significant .


sOXN was well tolerated .


Significant reductions in drug liking and other subjective effects following administration of sOXN compared with OXY indicate that naloxone concentrations were sufficient to antagonize the effects of oxycodone when abused by the intravenous route of administration in opioid-experienced drug users .


Impaired trunk motor control is common after stroke .


Combining transcutaneous electrical nerve stimulation ( TENS ) with task-related trunk training ( TRTT ) has been shown to enhance the recovery of lower limb motor function .


This study investigated whether combining TENS with TRTT would enhance trunk control after stroke .


Methods .


Thirty-seven subjects with stroke were recruited into a randomized controlled clinical trial .


Subjects were randomly assigned to any one of the three 6-week home-based training groups : ( 1 ) TENS + TRTT , ( 2 ) placebo TENS + TRTT , or ( 3 ) control without active training .


The outcome measures included isometric peak trunk flexion torque and extension torque ; forward seated and lateral seated reaching distance to the affected and unaffected side ; and Trunk Impairment Scale ( TIS ) scores .


All outcome measures were assessed at baseline , after 3 and 6 weeks of training , and 4 weeks after training ended at follow-up .


Both the TENS + TRTT and the placebo-TENS + TRTT groups had significantly greater improvements in isometric peak trunk flexion torque and extension torque , lateral seated reaching distance to affected and unaffected side , and TIS score than the control group after 3 weeks of training .


The TENS + TRTT group had significantly greater and earlier improvement in its mean TIS score than the other 2 groups .


Home-based TRTT is effective for improving trunk muscle strength , sitting functional reach and trunk motor control after stroke in subjects without somatosensory deficits .


The addition of TENS to the trunk augments the effectiveness of the exercise in terms of TIS scores within the first 3 weeks of training .


This study was performed to investigate the effect of Seidlitzia rosmarinus on the clinical symptoms of benign prostatic hyperplasia .


This single-blind clinical trial included 98 patients with voiding and storage symptoms in Shohada Ashayer Hospital of Khorramabad .


The patients were randomly divided into two groups of treatment with prazosin 1mg/day plus Seidlitzia rosmarinus 3g/day and treatment with prazosin 1mg/day .


The clinical symptoms were measured using the International Prostate Symptoms Score ( IPSS ) questionnaire .


Serum prostate-specific antigen ( PSA ) level , prostate volume , and residual urine volume before and 2 months after the intervention were measured .


The results of the study before the intervention did not show significant differences between the prazosin and Seidlitzia rosmarinus plus prazosin groups for the scores of clinical symptoms , PSA level , prostate volume , and residual urine volume ( p > 0.05 ) .


However , significant differences were found between the two groups after the intervention for the mean change scores of clinical symptoms ( 6.8 scores in the Seidlitzia rosmarinus group vs. 2 scores in the control group ) ( p < 0.001 ) , while no significant differences were found for the mean change scores of PSA level , prostate volume , and residual urine volume ( p > 0.05 ) .


The results of the study showed that the simultaneous consumption of Seidlitzia rosmarinus and prazosin , compared to the consumption of prazosin alone , results in significant improvements in the clinical symptoms of benign prostatic hyperplasia .


To evaluate whether a disease activity guided strategy of dose reduction of two tumour necrosis factor ( TNF ) inhibitors , adalimumab or etanercept , is non-inferior in maintaining disease control in patients with rheumatoid arthritis compared with usual care .


Randomised controlled , open label , non-inferiority strategy trial .


Two rheumatology outpatient clinics in the Netherlands , from December 2011 to May 2014 .


180 patients with rheumatoid arthritis and low disease activity using adalimumab or etanercept ; 121 allocated to the dose reduction strategy , 59 to usual care .


Disease activity guided dose reduction ( advice to stepwise increase the injection interval every three months , until flare of disease activity or discontinuation ) or usual care ( no dose reduction advice ) .


Flare was defined as increase in DAS28-CRP ( a composite score measuring disease activity ) greater than 1.2 , or increase greater than 0.6 and current score of at least 3.2 .


In the case of flare , TNF inhibitor use was restarted or escalated .


Difference in proportions of patients with major flare ( DAS28-CRP based flare longer than three months ) between the two groups at 18 months , compared against a non-inferiority margin of 20 % .


Secondary outcomes included TNF inhibitor use at study end , functioning , quality of life , radiographic progression , and adverse events .


Dose reduction of adalimumab or etanercept was non-inferior to usual care ( proportion of patients with major flare at 18 months , 12 % v 10 % ; difference 2 % , 95 % confidence interval -12 % to 12 % ) .


In the dose reduction group , TNF inhibitor use could successfully be stopped in 20 % ( 95 % confidence interval 13 % to 28 % ) , the injection interval successfully increased in 43 % ( 34 % to 53 % ) , but no dose reduction was possible in 37 % ( 28 % to 46 % ) .


Functional status , quality of life , relevant radiographic progression , and adverse events did not differ between the groups , although short lived flares ( 73 % v 27 % ) and minimal radiographic progression ( 32 % v 15 % ) were more frequent in dose reduction than usual care .


A disease activity guided , dose reduction strategy of adalimumab or etanercept to treat rheumatoid arthritis is non-inferior to usual care with regard to major flaring , while resulting in the successful dose reduction or stopping in two thirds of patients.Trial registration Dutch trial register ( www.trialregister.nl ) , NTR 3216 .


Peeping testis is an inconsistently palpable/seen undescended testis that migrates back and forth at the internal inguinal ring .


Both open and laparoscopic orchiopexy are effective forms of management .


The present study aimed to evaluate the efficacy and safety of both approaches .


Between September 2007 and January 2012 , 46 peeping inguinal testes were randomly treated with either open ( 25 cases ) or laparoscopic ( 21 cases ) orchiopexy procedures .


Spermatic vessels were preserved for all cases .


Operative details , postoperative morbidity and final testicular site and size were recorded .


The median age of the children was 2.5 years ( range 0.5-12 .0 ) .


The follow-up period ranged from 1.0 to 5.5 years .


Of these testes , 20 in the open surgery group and 19 in the laparoscopic group maintained correct intrascrotal position ( P = 0.428 ) .


Re-do orchiopexy was indicated for two cases in the surgical group ( P = 0.493 ) .


No cases of testicular atrophy or hernia were encountered .


Open and laparoscopic orchiopexy procedures for peeping testes are fairly comparable .


However , laparoscopy is relatively more effective , as two re-do orchiopexies were required in the open surgical group .


The recommended screening interval when using the Papanicolaou ( Pap ) and human papillomavirus ( HPV ) test ( co-testing ) is 5 years .


However because providers are reluctant to extend the screening interval , we launched a study to identify barriers to appropriate use of the co-test and to implement an educational intervention to promote evidence-based screening practices .


This article provides an overview of the study including the multi-component intervention and participant demographics .


The study was conducted in 15 clinics associated with 6 Federally Qualified Health Centers ( FQHCs ) in Illinois .


Each clinic received HPV tests to administer with routine Pap tests among enrolled patients ( n = 2,246 ) and was assigned to a study arm : intervention arm ( n = 7 ) received a multi-component educational intervention ( small media , academic detailing , and website ) for providers and printed educational materials for patients , and control arm ( n = 8 ) received printed copies of general guidelines .


Clinic coordinators ( n = 15 ) , providers ( n = 98 ) , and patients ( n = 984 ) completed baseline surveys to assess screening practices .


Providers reported an average age of 41.3 years and were predominately female , non-Hispanic , and white .


Patients reported an average age of 45.0 years and nearly two-thirds were Hispanic or black .


Of the 2,246 patients , 89 % had a normal co-test .


Lessons learned from the study included the importance of buy-in at a high level in the organization , a champion provider , and a clinical coordinator devoted to the study .


Materials from this study can be adapted to educate providers and patients on appropriate use of the co-test and encourage extended screening intervals as a safe and effective practice .


To compare the effectiveness of a core stability program with a task-oriented motor training program in improving motor proficiency in children with developmental coordination disorder ( DCD ) .


Randomized controlled pilot trial .


Outpatient unit in a hospital .


Twenty-two children diagnosed with DCD aged 6-9 years were randomly allocated to the core stability program or the task-oriented motor program .


Both groups underwent their respective face-to-face training session once per week for eight consecutive weeks .


They were also instructed to carry out home exercises on a daily basis during the intervention period .


Short Form of the Bruininks-Oseretsky Test of Motor Proficiency ( Second Edition ) and Sensory Organization Test at pre - and post-intervention .


Intention-to-treat analysis revealed no significant between-group difference in the change of motor proficiency standard score ( P = 0.717 ) , and composite equilibrium score derived from the Sensory Organization Test ( P = 0.100 ) .


Further analysis showed significant improvement in motor proficiency in both the core stability ( mean change ( SD ) = 6.3 ( 5.4 ) ; p = 0.008 ) and task-oriented training groups ( mean change ( SD ) = 5.1 ( 4.0 ) ; P = 0.007 ) .


The composite equilibrium score was significantly increased in the task-oriented training group ( mean change ( SD ) = 6.0 ( 5.5 ) ; P = 0.009 ) , but not in the core stability group ( mean change ( SD ) = 0.0 ( 9.6 ) ; P = 0.812 ) .


In the task-oriented training group , compliance with the home program was positively correlated with change in motor proficiency ( = 0.680 , P = 0.030 ) and composite equilibrium score ( = 0.638 , P = 0.047 ) .


The core stability exercise program is as effective as task-oriented training in improving motor proficiency among children with DCD .


Plantago ovata husk therapy could be used in patients with Parkinson disease to reduce the symptoms of gastrointestinal disorders , but it is important to know whether this compound modifies levodopa pharmacokinetics .


The maintenance of constant plasma concentrations of levodopa abolishes the clinical fluctuations in parkinsonian patients .


The aim of this randomised clinical trial was to establish the influence of the fiber Plantago ovata husk in the pharmacokinetics of levodopa when administered to Parkinson patients well controlled by their oral medication .


To evaluate the effects of this fiber on several biochemical parameters .


18 volunteers participated in the study and received alternatively two treatments ( Plantago ovata husk or placebo ) with their usual levodopa/carbidopa oral dose .


On days 0 ( initial situation ) , 14 and 35 of the study , blood samples were taken to assess levodopa pharmacokinetics and to determine biochemical parameters .


Levodopa Cmax was very similar in the initial situation ( 603.2 ng/ml ) and after placebo administration ( 612.0 ng/ml ) , being slightly lower ( 547.8 ng/ml ) when Plantago ovata husk was given .


AUC was very similar in the three groups : initial situation .


- 62.87 g.min / ml , fiber treatment .


- 64.47 g.min / ml and placebo treatment .


- 65.10 g.min / ml .


Fiber reduced significantly the number of peaks observed in the levodopa concentrations , maintaining concentrations more stable .


No significant differences were found in total cholesterol , LDL-cholesterol and triglycerides with the administration of Plantago ovata husk .


Plantago ovata husk administration caused a smoothing and homogenization of levodopa absorption , providing more stable concentrations and final higher levels , resulting in a great benefit for patients .


EudraCT2006-000491-33 .


To investigate the effect of Longbishu Capsule ( , LBS ) , doxazosin , and combination therapy on benign prostatic hyperplasia ( BPH ) .


A randomized , double-blind , multi-center parallel trial was conducted involving 360 patients in hospitals in Beijing ( 108 cases ) , Heilongjiang ( 90 cases ) , Sichuan ( 90 cases ) , Shanghai ( 72 cases ) , China .


They were randomly assigned with central randomization method to group A ( LBS placebo plus doxazosin ) , group B ( LBS plus doxazosin ) or group C ( LBS plus doxazosin placebo ) , 120 cases for each group .


The international prostate symptom score , maximum urinary flow rate , postvoid residual urine volume and prostate volume were measured for evaluating the efficacy of the three treatments .


At baseline , there was no significant difference in the measured variables among the three groups .


After 12-month treatment , the three groups showed significant improvements in IPSS and maximum urinary flow rate from baseline ( P < 0.01 ) .


Although postvoid residual urine volume was not significantly different from the baseline in group A ( P > 0.05 ) , it significantly decreased in group B and C ( P < 0.05 ) .


The incidence of adverse events were similar among the three groups .


The treatment of LBS alone or LBS plus doxazosin was able to significantly improve IPSS in patients with BPH .


The treatments may reduce the increase in prostate volume and postvoid residual urine volume as well .


Inhalational induction in children is easiest to perform with the Ayres t-piece & bag ( Mapleson F ) .


Drawover anesthesia systems may be used but have not been studied .


The aim of this study was to examine the quality of induction of anesthesia in children comparing a continuous flow system using the Farman entrainer and the pediatric t-piece , to a pediatric drawover system .


We conducted a randomized controlled trial in accordance with departmental and institutional standards with 60 subjects who received inhalational induction using either apparatus .


There was no evidence of a difference in the median Sp02 between the two methods ( P = 0.626 ) neither was there a difference between the method of induction regarding abdominal distension ( P = 0.348 ) or restraint ( P = 0.186 ) .


Induction time using the pediatric drawover apparatus 240 ( range 115-605 ) seconds was significantly greater than the Farman entrainer/t-piece 146 ( range 65-535 ) seconds ( P < 0.05 ) .


We consider that this difference is unlikely to be clinically significant in many cases ; however , the increased speed using the entrainer and t-piece may sometimes confer an advantage .


The reliability and validity of various Objective Structured Clinical Examinations ( OSCEs ) have been well documented in the medical and nursing literature .


The purpose of this study was to examine the effect of exam preparation methods on student performance and student satisfaction for an OSCE used to assess doctoral physical therapist students .


Sixty-five physical therapist students from two post-professional physical therapist programs were randomized to a rubric exam preparation group and a nonrubric exam preparation group for a musculoskeletal OSCE .


The OSCE was a midterm practical exam for a peripheral joint musculoskeletal course .


Upon completion of the exam , all students completed a post-exam satisfaction survey .


The results of the 2 x 2 ANCOVA that examined performance and satisfaction on the OSCE indicated a significant interaction between the group assignment and program , p < 0.028 , for performance , and that satisfaction scores between the rubric and nonrubric groups and program were not significant for any of the questions asked on the post-examination survey .


Despite the reported benefit of utilizing rubrics , the findings of this study did not show a difference in student performance or satisfaction when using a rubric to prepare for an OSCE .


Single-site studies have demonstrated inadequate quality of discharge summaries in timeliness , transmission , and content , potentially contributing to adverse outcomes .


However , degree of hospital-level variation in discharge summary quality for patients hospitalized with heart failure ( HF ) is uncertain .


We analyzed discharge summaries of patients enrolled in the Telemonitoring to Improve Heart Failure Outcomes ( Tele-HF ) study .


We assessed hospital-level performance on timeliness ( fraction of summaries completed on the day of discharge ) , documented transmission to the follow-up physician , and content ( presence of components suggested by the Transitions of Care Consensus Conference ) .


We obtained 1501 discharge summaries from 1640 ( 91.5 % ) patients discharged alive from 46 hospitals .


Among hospitals contributing 10 summaries , the median hospital dictated 69.2 % of discharge summaries on the day of discharge ( range , 0.0 % -98.0 % ; P < 0.001 ) ; documented transmission of 33.3 % of summaries to the follow-up physician ( range , 0.0 % -75.7 % ; P < 0.001 ) ; and included 3.6 of 7 Transitions of Care Consensus Conference elements ( range , 2.9-4 .5 ; P < 0.001 ) .


Hospital course was typically included ( 97.2 % ) , but summaries were less likely to include discharge condition ( 30.7 % ) , discharge volume status ( 16.0 % ) , or discharge weight ( 15.7 % ) .


No discharge summary included all 7 Transitions of Care Consensus Conference-endorsed content elements , was dictated on the day of discharge , and was sent to a follow-up physician .


Even at the highest performing hospital , discharge summary quality is insufficient in terms of timeliness , transmission , and content .


Improvements in all aspects of discharge summary quality are necessary to enable the discharge summary to serve as an effective transitional care tool .


To evaluate and compare the effcacy of preprocedural mouthrinses ( chlorhexidine digluconate and tea tree oil ) in reducing microbial content of aerosol product during ultrasonic scaling procedures by viable bacterial count .


It was a randomized single blind , placebo-controlled parallel group study .


Sixty subjects were randomly assigned to rinse 10 ml of any one of the mouthrinses ( chlorhexidine digluconate or tea tree oil or distilled water ) .


Ultrasonic scaling was done for a period of 10 minutes in presence of trypticase soy agar plates placed at standardized distance .


Plates were then sent for microbiological evaluation for the aerosol produced .


This study showed that all the antiseptic mouthwashes signifcantly reduced the bacterial colony forming units ( CFUs ) in aerosol samples .


Chlorhexidine rinses were found to be superior to tea tree when used preprocedurally in reducing aerolized bacteria .


This study advocates preprocedural dural rinsing with an effective antimicrobial mouthrinse during any dental treatment which generates aerosols , reduces the risk of cross-contamination with infectious agents in the dental operatory .


The aerolization of oral microbes occurring during dental procedures can potentially result in cross-contamination in the dental operatory and transmission of infectious agents to both dental professionals and patient .


It is reasonable to assume therefore , that any stratagem for reducing the viable bacterial content of these aerosols could lower the risk of cross-contamination .


We investigated the effects of weight loss and maintenance with diets that varied with regard to protein content and glycemic index ( GI ) on metabolic syndrome ( MetSyn ) status .


Secondary analyses were performed within the Diet , Obesity and Genes ( DiOGenes ) study ( 2006-2008 ) , a randomized controlled dietary intervention .


Nine hundred and thirty-eight overweight and obese adults from eight European countries entered an 8-wk low-calorie-diet period .


Seven hundred and seventy-three adults who lost at least 8 % of their body weights were randomized to one of five ad libitum diets for 6 mo : 1 ) low-protein ( LP ) / low-GI ( LGI ) ; 2 ) LP/high-GI ( HGI ) ; 3 ) high-protein ( HP ) / LGI ; 4 ) HP/HGI ; and 5 ) control diet .


MetSyn prevalence and a standardized MetSyn score were assessed at baseline , after the low-calorie diet , and after the intervention .


Weight loss among participants while on the low-calorie diet significantly reduced MetSyn prevalence ( 33.9 % versus 15.9 % ; P < 0.001 ) and MetSyn score ( -1.48 versus -4.45 ; P < 0.001 ) .


During weight maintenance , significant changes in MetSyn score were observed between the groups , with the highest increase detected in the LP/HGI group ( P = 0.039 , partial ( 2 ) = 0.023 ) .


Protein , GI , and their interaction did not have isolated effects on study outcomes .


Neither protein nor GI affected MetSyn status in this sample of European overweight and obese adults .


However , a diet with a combination of an increased protein-to-carbohydrate ratio with low-GI foods had beneficial effects on MetSyn factors .


To evaluate the optimal time interval from definitive surgery to commencing chemotherapy in early breast cancer ( EBC ) .


The relationship between time to initiation of adjuvant chemotherapy ( TTC ) , calculated in weeks , and disease-free ( DFS ) or overall survival ( OS ) , was assessed in 921 EBC patients with rapidly proliferating tumours ( thymidine labelling index > 3 % or G3 or Ki67 > 20 % ) , randomised in a phase III clinical trial ( NCT01031030 ) to receive chemotherapy with or without anthracyclines ( epirubicincyclophosphamide , methotrexate and fluorouracil ( CMF ) versus CMFepirubicin versus CMF ) .


DFS , OS and 95 % confidence intervals ( 95 % confidence interval ( CI ) ) were calculated by the Kaplan-Meier method .


Multivariate Cox analysis was performed in relation with nodal involvement , oestrogen receptor and human epidermal growth factor receptor 2 ( HER2 ) status , Ki67 value , type of adjuvant chemotherapy , menopausal status and tumour size .


At a median follow-up of 105 months ( range 2-188 ) , a prolonged TTC resulted in a significant increase in the risk of relapse : hazard ratio ( HR ) 1.15 ( 95 % CI 1.02-1 .30 , p = 0.019 ) .


Using a backward elimination procedure , TTC , tumour size and nodal involvement remained significantly associated with DFS .


A time-dependent receiver-operating characteristic ( ROC ) curve analysis was subsequently utilised to evaluate the best cut-off for TTC , identifying 7 weeks as the best threshold for longer OS ( p = 0.043 ) : 8-year OS 88 % ( 95 % CI 85-90 ) for patients with a TTC < 7 weeks and 78 % ( 95 % CI 68-87 ) for the other group .


Our results confirm that a shorter TTC may reduce relapses and possibly also improve clinical outcome in patients with highly proliferating EBC .


The purpose of this study was to evaluate the relative bioavailability and safety of a multilayer extended-release bead methylphenidate ( MPH ) hydrochloride 80mg ( MPH-MLR ) capsule or sprinkles ( 37 % immediate-release [ IR ] ) versus MPH hydrochloride IR ( Ritalin ( ) ) tablets , and to develop a pharmacokinetic ( PK ) model simulating MPH concentration-time data for different MPH-MLR dosage strengths .


This was a single-center , randomized , open-label , three-period crossover study conducted in 26 fasted healthy adults ( mean weightstandard deviation , 70.411.7 kg ) assigned to single-dose oral MPH-MLR 80mg capsule or sprinkles with applesauce , or Ritalin IR 25mg ( 15mg and 120mg tablet ) administered at 0 , 4 , and 8 hours .


MPH-MLR 80mg capsule and sprinkles were bioequivalent ; ratios for maximum concentration ( Cmax ) , area under plasma drug concentration versus time curve ( AUC ) 0-t , and AUC0-inf were 1.04 ( 95 % confidence interval [ CI ] , 96.3-112 .4 ) , 0.99 ( 95 % CI , 95.3-102 .8 ) , and 0.99 ( 95 % CI , 95.4-103 .0 ) , respectively .


MPH-MLR capsule/sprinkles produced highly comparable , biphasic profiles of plasma MPH concentrations characterized by rapid initial peak , followed by moderate decline until 5 hours postdose , and gradual increase until 7 hours postdose , culminating in an attenuated second peak .


Based on 90 % CIs , total systemic exposure to MPH-MLR 80mg capsule/sprinkles was similar to that for Ritalin IR 25mg three times daily , but marked differences in Cmax values indicated that MPH-MLR regimens were not bioequivalent to Ritalin .


MPH Cmax and total systemic exposure over the first 4 hours postdose with MPH-MLR capsule/sprinkles was markedly higher than that associated with the first dose of Ritalin .


All study drugs were safe and well tolerated .


The PK modeling in adults suggested that differences in MPH pharmacokinetics between MPH-MLR and Ritalin are the result of dosage form design attributes and the associated absorption profiles of MPH .


MPH-MLR 80mg provides a long-acting biphasic pattern of plasma MPH concentrations with one less peak and trough than Ritalin IR .


The authors evaluated the effect of susceptibility-weighted imaging ( SWI ) for antiplatelet therapy on post-thrombolysis microbleeds ( MB ) .


A total of 146 patients without symptomatic intracranial haemorrhage on computed tomography after thrombolysis were allocated to two groups : group A ( n = 72 ) received antiplatelets 24h after recombinant tissue plasminogen activator , regardless of SWI-detected haemorrhage ; group B ( n = 74 ) received antiplatelets for patients without SWI-visualised haemorrhage .


Haemorrhage was detected by SWI in 22 and 28 patients in groups A and B , respectively .


The difference in mean NIHSS ( National Institutes of Health Stroke Scale ) score in group A between baseline and 6 , 24h , 7 , 14days was -1.6 , -1.7 , -3.6 , -5.9 , respectively ; in group B , the difference in mean NIHSS score between baseline and 6 , 24h , 7 , 14days was -2.6 , -3.3 , -5.4 , -8.7 , respectively .


The difference between groups in reduction of mean NIHSS score from baseline was 1.0 ( p < 0.001 ) at 6h , 1.6 ( p < 0.001 ) at 24h , 1.8 ( p = 0.001 ) at 7days and 2.8 ( p < 0.001 ) at 14days .


NIHSS scores at 7 , 14days and modified Rankin scale at 90days were significantly lower in haemorrhage patients in groups B than in A , whereas the hospital stay was shorter and the rate of favourable outcome at 90days was higher .


Our results indicated that SWI was an effective approach for the guidance of antiplatelet therapy in post-thrombolysis MB .


Medication errors can be caused by lack of agreement between what physicians believe patients are taking and what patients actually take .


There has been little systematic research to find the best way to reconcile medication lists in primary care .


The objective of this study was to assess the impact of 2 interventions on agreement between electronic medical record medication lists and what patients report actually taking .


This study was a factorial randomized trial that randomized 440 eligible patients ( English-speaking , age 18 and older , taking at least 2 prescriptions ) visiting 20 primary care physicians ; 367 completed the study .


Interventions included ( 1 ) providing patients a printed copy of their current medication list at check-in and ( 2 ) beginning the medication review with an open-ended question .


Patients were randomized to receive no intervention , one or the other intervention , or both interventions .


The outcome measure was agreement on all prescription and nonprescription medications , vitamins , and supplements between the list from the electronic medical record after the visit and a list based on patient report generated during a phone interview within a week of the office visit .


Agreement rates between medication lists and patient report for the 4 study groups were : 67.4 % in the no intervention group , 66.7 % in the printed list only group , 58.1 % in the open-ended question only group , and 75.6 % in the combined intervention group .


Both a printed list and beginning a medication discussion with an open-ended question were required before any significant increase in agreement was observed .


While neither intervention alone improved medication list agreement , these interventions may have value in a multistep protocol to improve the agreement of medication lists in primary care offices .


Baseline agreement was much higher than expected , possibly reflecting a Hawthorne effect .


This study aimed to determine the effectiveness of using a wireless , portable vital signs monitor ( WVSM ) for predicting the need for lifesaving interventions ( LSIs ) in the emergency department ( ED ) and use a multivariate logistic regression model to determine whether the WVSM was an improved predictor of LSIs in the ED over the standard of care monitor currently being used .


This study analyzed 305 consecutive patients transported from the scene via helicopter to a Level I trauma center .


For 104 patients in the study , a WVSM was also attached to the patient 's arm and used to record and display prehospital and hospital physiologic data in real time on a handheld computer and in the trauma bay .


Multivariate logistic regression analyses were performed for accuracy in predicting needs for LSIs in control and WVSM subjects .


In addition , receiver operating characteristic curves were obtained to examine the discriminating power of the models for the outcome of one or more LSIs in the ED .


Of the 305 patients , 73 underwent 109 LSIs in the ED .


Of these , 21 patients wore the WVSM during transport in addition to the standard monitor .


Logistic regression analysis revealed that heart rate , respiratory rate , and systolic blood pressure were significantly associated with an increased risk for LSIs in the ED ( p < 0.05 ) .


Receiver operating characteristic curve analysis also demonstrated better prediction for LSIs performed in the ED in WVSM subjects than in control subjects ( area under the curve , 0.86 vs. 0.81 , respectively ) .


The WVSM system leads to improved LSI accuracy in the ED .


In addition , many important lessons have been learned in preparation for this study .


Adoption of nonstandard vital signs monitors into critical care/trauma medicine may require a new paradigm of personnel education , training , and practice .


Therapeutic/care management , level IV .


Brief potentially ictal rhythmic discharges , termed B ( I ) RDs , have been described mainly in neonates , and their significance in adults remains unclear .


To describe the incidence of B ( I ) RDs in critically ill patients and investigate their association with seizures and outcome .


We reviewed the records of prospectively identified patients with B ( I ) RDs and patients serving as controls matched for age ( 5 years ) and primary diagnosis .


The prevalence of seizures during continuous electroencephalography and functional outcome , as measured by the Glasgow Outcome Scale , were determined .


We identified B ( I ) RDs in 20 patients ( 2 % ) .


The pattern most often consisted of very brief ( 1-3 seconds ) runs of sharply contoured theta activity without obvious evolution .


All patients with B ( I ) RDs had cerebral injury , and in cases with a single focal lesion ( 11 [ 55 % ] ) , B ( I ) RDs were localized in the same region in all but 2 cases ( 18 % ) .


Patients with B ( I ) RDs were more likely to have seizures during continuous electroencephalography than were patients without B ( I ) RDs ( 15 of 20 [ 75 % ] vs 10 of 40 [ 25 % ] ; P < .001 ) , and 9 patients with B ( I ) RDs ( 60 % ) had only subclinical seizures .


Brief potentially ictal rhythmic discharges were identified before seizures in all but 1 case ( 93 % ) and ceased in all 12 cases ( 80 % ) in which seizures were controlled .


Patients with B ( I ) RDs tended to have a worse outcome than controls ( 16 [ 80 % ] vs 25 [ 63 % ] ) ; however , this finding was not statistically significant .


Brief potentially ictal rhythmic discharges in critically ill patients are associated with a high prevalence ( 75 % ) of electrographic seizures and might serve as an early predictor of seizures during subsequent monitoring .


A larger prospective study is needed to better understand their clinical and prognostic significance .


To investigate whether strength decline in post-polio syndrome ( PPS ) results from excessive distal axonal degeneration of enlarged motor units .


We assessed changes over 10 years in isometric quadriceps strength , mean motor unit action potential ( MUAP ) size , root mean squared ( RMS ) amplitude , and level of interference ( LOI ) in 47 patients with PPS and 12 healthy controls , using high density surface EMG .


At baseline , all patients had symptomatic quadriceps dysfunction , evidenced by transmission defects on single-fibre EMG .


MU size and strength declined significantly by 20 % and 15 % , respectively in patients with PPS .


Those with the largest initial MU sizes exhibited the greatest losses of mean MU size ( 27 % ) and proportional decreases in quadriceps strength ( 23 % ) .


Initial strength , change in LOI and change in RMS amplitude together explained 35 % of the variability in strength changes in patients .


MU size of controls did not change , although they lost 29 % strength .


MU size and strength declined concomitantly in a homogeneous cohort of patients with PPS and quadriceps dysfunction .


This long term follow-up study provides evidence that size diminution of enlarged MUs combined with a reduced number of active MUs contributes to the gradual strength decline in PPS .


A high incidence of diabetes mellitus has been reported among patients diagnosed with lumbar degenerative spinal diseases .


Although epidural steroid injections are known to increase the postprocedure blood glucose level , it has not been investigated whether a lower steroid dose can reduce blood glucose excursions and still be effective in controlling patients ' subjective pain .


We compared the effects of 2 common doses of triamcinolone administered via epidural steroid injections on blood glucose levels and pain control in patients with diabetes mellitus to determine an adequate epidural steroid dose .


A prospective observational study .


One hundred patients with diabetes mellitus were enrolled .


They received lumbar transforaminal , lumbar interlaminar , or caudal epidural triamcinolone for radiculopathy , spinal stenosis , or failed back surgery syndrome .


After the type of procedure was clinically determined , the doses of triamcinolone given were randomly chosen , either 40 mg ( Group 40 ) or 20 mg ( Group 20 ) .


The patients were asked to measure their finger stick blood glucose level twice daily ( fasting and postprandial ) for 3 days before the injection , on the day of the injection , for 7 days after the injection , and at 14 days after the injection .


They also kept a blood glucose diary .


Employment status and clinical outcome were evaluated at 8 weeks after the procedure .


There were significant increases in fasting blood glucose ( FBG ) level on postprocedure day ( PPD ) # 1 to PPD # 3 in Group 40 , but on PPD # 1 in Group 20 .


Moreover , there was a significant difference in FBG between groups on PPD # 1 and PPD # 2 ( FBG on PPD # 1 : 179 [ 51 ] ) mg/dL in Group 40 versus 146 [ 50 ] mg/dL in Group 20 , P < 0.001 ] .


Postprandial blood glucose ( PBG ) level was significantly elevated in both groups from PPD # 0 to PPD # 3 .


Notably , the increase in PBG was significantly greater in Group 40 than Group 20 on PPD # 0 and # 1 ( PBG on PPD # 0 : 288 [ 57 ] mg/dL versus 242 [ 94 ] mg/dL in Groups 40 and 20 , respectively , P = 0.004 ) .


The numeric rating scale for pain reported by the patients decreased for 2 weeks after treatment with no difference between groups .


Employment status and clinical outcome was not different between groups .


The patients who chose to participate in this study may be a cohort of well-controlled patients with diabetes mellitus .


The type of procedure performed was determined by a clinical decision and not randomized .


The different routes of administration and diagnosis of failed back surgery syndrome can result in different levels of systemic absorption , thereby influencing the degree and duration of hyperglycemia .


In patients with FBSS , the epidural space may be destructed by surgery and adhesive changes in epidural space could be extensive .


Therefore , we thought that the absorption of epidural space in these patients would be incomplete or slow compared with those without FBSS .


Epidural steroid injections were associated with statistically significant elevations in PBG in patients with diabetes for up to 4 days after the procedure .


The higher dose of triamcinolone increased FBG and PBG greater than a lower dose did without affecting pain control , employment status , or clinical outcome .


Thus , with respect to glucose and pain control , 20 mg of triamcinolone appears to be recommended rather than 40 mg in patients with diabetes .


Clinical Trials registration : NCT01435707 .


The CORONIS Trial was a 22222 non-regular , fractional , factorial trial of five pairs of alternative caesarean section surgical techniques on a range of short-term outcomes , the primary outcome being a composite of maternal death or infectious morbidity .


The consequences of different surgical techniques on longer term outcomes have not been well assessed in previous studies .


Such outcomes include those related to subsequent pregnancy : mode of delivery ; abnormal placentation ( e.g. accreta ) ; postpartum hysterectomy , as well as longer term pelvic problems : pain , urinary problems , infertility .


The Coronis Follow-up Study aims to measure and compare the incidence of these outcomes between the randomised groups at around three years after women participated in the CORONIS Trial .


This study will assess the following null hypotheses : In women who underwent delivery by caesarean section , no differences will be detected with respect to a range of long-term outcomes when comparing the following five pairs of alternative surgical techniques evaluated in the CORONIS Trial : 1 .


Blunt versus sharp abdominal entry .


2 .


Exteriorisation of the uterus for repair versus intra-abdominal repair .


3 .


Single versus double layer closure of the uterus .


4 .


Closure versus non-closure of the peritoneum ( pelvic and parietal ) .


5 .


Chromic catgut versus Polyglactin-910 for uterine repair .


The outcomes will include ( 1 ) women 's health : pelvic pain ; dysmenorrhoea ; deep dyspareunia ; urinary symptoms ; laparoscopy ; hysterectomy ; tubal/ovarian surgery ; abdominal hernias ; bowel obstruction ; infertility ; death .


( 2 ) Outcomes of subsequent pregnancies : inter-pregnancy interval ; pregnancy outcome ; gestation at delivery ; mode of delivery ; pregnancy complications ; surgery during or following delivery .


The results of this follow-up study will have importance for all pregnant women and for health professionals who provide care for pregnant women .


Although the results will have been collected in seven countries with limited health care resources ( Argentina , Chile , Ghana , India , Kenya , Pakistan , Sudan ) any differences in outcomes associated with different surgical techniques are likely to be generalisable throughout the world .


ISRCTN31089967 .


Psychosocial interventions for bipolar disorder are frequently unavailable and resource intensive .


Mobile technology may improve access to evidence-based interventions and may increase their efficacy .


We evaluated the feasibility , acceptability and efficacy of an augmentative mobile ecological momentary intervention targeting self-management of mood symptoms .


This was a randomized single-blind controlled trial with 82 consumers diagnosed with bipolar disorder who completed a four-session psychoeducational intervention and were assigned to 10 weeks of either : 1 ) mobile device delivered interactive intervention linking patient-reported mood states with personalized self-management strategies , or 2 ) paper-and-pencil mood monitoring .


Participants were assessed at baseline , 6 weeks ( mid-point ) , 12 weeks ( post-treatment ) , and 24 weeks ( follow up ) with clinician-rated depression and mania scales and self-reported functioning .


Retention at 12 weeks was 93 % and both conditions were associated with high satisfaction .


Compared to the paper-and-pencil condition , participants in the augmented mobile intervention condition showed significantly greater reductions in depressive symptoms at 6 and 12 weeks ( Cohens d for both were d = 0.48 ) .


However , these effects were not maintained at 24-weeks follow up .


Conditions did not differ significantly in the impact on manic symptoms or functional impairment .


This was not a definitive trial and was not powered to detect moderators and mediators .


Automated mobile-phone intervention is feasible , acceptable , and may enhance the impact of brief psychoeducation on depressive symptoms in bipolar disorder .


However , sustainment of gains from symptom self-management mobile interventions , once stopped , may be limited .


The incidence of end-stage renal disease ( ESRD ) has been consistently shown to be higher among blacks and Hispanics compared to whites with unmeasured risk factors and access to care as suggested explanations .


In a high-risk cohort with frequent protocol-directed follow-up , we evaluated the influence of race on cardiovascular ( CV ) outcomes and incidence of ESRD .


TREAT was a randomized , double-blind , placebo-controlled study .


This secondary analysis focused on role of race on outcomes .


TREAT enrolled 4,038 patients with type 2 diabetes , chronic kidney disease ( estimated glomerular filtration rate 20-60 mL/min per 1.73 m ( 2 ) ) , and anemia ( hemoglobin level 11 g/dL ) treated with either darbepoetin alfa or placebo .


We compared self-described black and Hispanic patients to white patients with regard to baseline characteristics and outcomes , including mortality , CV outcomes ( myocardial infarction , stroke , heart failure , resuscitated sudden death , and coronary revascularization ) , and incident ESRD .


Multivariate adjusted Cox models were developed for these outcomes .


Black and Hispanic patients were younger , more likely women , had less prior CV disease , and higher blood pressure .


During a mean follow-up of 2.4 years with comparable access to care , blacks and Hispanics had a greater risk of ESRD but a significant lower risk of myocardial infarction and coronary revascularization than whites .


After adjusting for confounders , blacks remained at significantly greater risk of ESRD than whites ( hazard ratio 1.53 , 95 % CI 1.26-1 .85 , P < .001 ) , whereas this ESRD risk did not persist among Hispanics .


Despite similar access to care and lower CV event rates , the risk of ESRD was higher among blacks and Hispanics than whites .


For blacks , but not Hispanics , this increase was independent of known attributable risk factors .


Generic preference-based measures were criticized for being inappropriate in some conditions .


One solution is to include `` bolt-on '' dimensions describing additional specific health problems .


This study aimed to develop bolt-on dimensions to the EuroQol five-dimensional questionnaire ( EQ-5D ) and assess their impact on health state values .


Bolt-on dimensions were developed for vision problems , hearing problems , and tiredness .


Each bolt-on dimension had three severity levels to match the EQ-5D .


Three `` core '' EQ-5D states across a range of severity were selected , and each level of a bolt-on item was added , resulting in nine states in each condition .


Health states with and without the bolt-on dimensions were valued by 300 members of the UK general public using time trade-off in face-to-face interviews , and mean health state values were compared using t tests .


Regression analysis examined the impact of the bolt-on variants and the level of the bolt-on items after controlling for sociodemographic characteristics .


Bolt-on dimensions had an impact on health state values of the EQ-5D ; however , the size , direction , and significance of the impact depend on the severity of the core EQ-5D state and of the bolt-on dimension .


Regression analysis demonstrated that after controlling for possible differences in sociodemographic characteristics between the groups , there were no significant differences in health state values between the three bolt-on dimensions but confirmed that the impact depended on the severity of the EQ-5D health state and the levels of bolt-on dimensions .


The impact of a bolt-on dimension on the EQ-5D depends on the core health state and the level of the bolt-on dimension .


Further research in this area is encouraged .


Studies suggest that giving newly born preterm infants sustained lung inflation ( SLI ) may decrease their need for mechanical ventilation ( MV ) and improve their respiratory outcomes .


We randomly assigned infants born at 25 weeks 0 days to 28 weeks 6 days of gestation to receive SLI ( 25 cm H2O for 15 seconds ) followed by nasal continuous positive airway pressure ( nCPAP ) or nCPAP alone in the delivery room .


SLI and nCPAP were delivered by using a neonatal mask and a T-piece ventilator .


The primary end point was the need for MV in the first 72 hours of life .


The secondary end points included the need for respiratory supports and survival without bronchopulmonary dysplasia ( BPD ) .


A total of 148 infants were enrolled in the SLI group and 143 in the control group .


Significantly fewer infants were ventilated in the first 72 hours of life in the SLI group ( 79 of 148 [ 53 % ] ) than in the control group ( 93 of 143 [ 65 % ] ) ; unadjusted odds ratio : 0.62 [ 95 % confidence interval : 0.38-0 .99 ] ; P = .04 ) .


The need for respiratory support and survival without BPD did not differ between the groups .


Pneumothorax occurred in 1 % ( n = 2 ) of infants in the control group compared with 6 % ( n = 9 ) in the SLI group , with an unadjusted odds ratio of 4.57 ( 95 % confidence interval : 0.97-21 .50 ; P = .06 ) .


SLI followed by nCPAP in the delivery room decreased the need for MV in the first 72 hours of life in preterm infants at high risk of respiratory distress syndrome compared with nCPAP alone but did not decrease the need for respiratory support and the occurrence of BPD .


This study aimed to evaluate the efficacy of aprepitant , a neurokinin ( NK ) 1 receptor antagonist , on chemotherapy-induced nausea and vomiting ( CINV ) .


A randomized , open-labeled , parallel-design study was undertaken in gynecologic-cancer ( GC ) patients at the Fukuoka University Hospital .


Twenty-three patients were divided into without ( group A ) or with aprepitant ( Group B ) in the first cycle of paclitaxel and carboplatin ( TC ) therapy .


From the second cycle onwards , all patients used aprepitant .


Statistical significance was assessed using McNemar and Chi-square tests .


In the first cycle , the prevalence of a complete response , no episodes of nausea or food intake in group B was significantly increased compared to group A. No significant difference in the prevalence of a complete response or food intake situation was found from the second cycle onwards .


Combination of aprepitant with standard anti-emetic therapy may contribute to prevention of CINV in TC therapy for GC patients .


Pemphigus is an autoimmune blistering mucocutaneous disorder .


Common treatments include corticosteroids and immunosuppressive drugs .


This study aimed to assess the therapeutic effects of oral prednisolone along with the common adjuvant therapy in pemphigus vulgaris .


Eighty-seven patients with pemphigus vulgaris from the first stage of a previously randomized clinical trial were enrolled in the present non-blinded clinical trial .


The patients were divided into four groups and treated accordingly with prednisolone alone ( P ; N = 23 ) , prednisolone and azathioprine ( P/A ; N = 23 ) , prednisolone and mycophenolate mofetil ( P/M ; N = 21 ) , and prednisolone and cyclophosphamide ( P/C ; N = 20 ) .


These patients were followed-up for an extended one-year period .


The primary localization of the recurrence occurred in the oral cavity of 7 , 6 , 2 , and 5 patients in the P , P/A , P/M , and P/C groups , respectively .


There was no significant difference between them ( P = 0.40 ) .


The mean total dose of prednisolone administered in groups P , P/A , P/M , and P/C was accordingly 7.5 , 8.4 , 9.2 , and 8.6 mg/day .


Minor recurrence of the disease in the above-mentioned groups was observed in 7 ( 30.4 % ) , 5 ( 21.7 % ) , 6 ( 28.6 % ) , and 7 ( 35.0 % ) of the patients , respectively .


With regard to the minor recurrence of the disease , there was no significant difference among the four treatment groups ( P = 0.80 ) .


Since in this follow-up study no therapeutic benefit of oral prednisolone and common adjuvant therapy was found in terms of the number of minor and major recurrences , the extent to which treatment of PV can be improved upon treatment with these agents remains to be elucidated .


The purpose of this study was to investigate the immediate effects of traditional Thai massage ( TTM ) on psychological stress and heart rate variability ( HRV ) .


Thirty healthy participants were randomly allocated in two groups , a TTM group ( n = 15 ) who received a 1-hour session with moderate pressure of whole body TTM or a control group ( n = 15 ) who rested on the bedfor 1 hour All ofthem were given a 10-minute mental arithmetic test to induce psychological stress after which they received a 1-hour session of TTM or bed rest .


Psychological stress and HR V were measured at baseline and immediately after mental arithmetic test , and immediately after TTM or bed rest .


The studyfound that psychological stress was signficantly increased ( p < 0.05 ) after mental arithmetic test in both groups .


Comparison on these measures between immediately after mental arithmetic test and after TTM or bed rest revealed that psychological stress was significantly decreased ( p < 0.05 ) and HR Vwas significantly increased ( p < 0.05 ) in both groups .


Root mean square of successive differences ( RMSSD ) and low frequency were significantly increased ( p < 0.05 ) only in the TTM group .


However ; all of these measures were found without significant difference when groups were compared .


TTM and bed rest could decrease psychological stress and HRV


More than a third of the approximately 10 million women with histories of interpersonal violence in the United States develop posttraumatic stress disorder ( PTSD ) .


Currently available treatments for this population have a high rate of incomplete response , in part because problems in affect and impulse regulation are major obstacles to resolving PTSD .


This study explored the efficacy of yoga to increase affect tolerance and to decrease PTSD symptomatology .


Sixty-four women with chronic , treatment-resistant PTSD were randomly assigned to either trauma-informed yoga or supportive women 's health education , each as a weekly 1-hour class for 10 weeks .


Assessments were conducted at pretreatment , midtreatment , and posttreatment and included measures of DSM-IV PTSD , affect regulation , and depression .


The study ran from 2008 through 2011 .


The primary outcome measure was the Clinician-Administered PTSD Scale ( CAPS ) .


At the end of the study , 16 of 31 participants ( 52 % ) in the yoga group no longer met criteria for PTSD compared to 6 of 29 ( 21 % ) in the control group ( n = 60 , = 6.17 , P = .013 ) .


Both groups exhibited significant decreases on the CAPS , with the decrease falling in the large effect size range for the yoga group ( d = 1.07 ) and the medium to large effect size decrease for the control group ( d = 0.66 ) .


Both the yoga ( b = -9.21 , t = -2.34 , P = .02 , d = -0.37 ) and control ( b = -22.12 , t = -3.39 , P = .001 , d = -0.54 ) groups exhibited significant decreases from pretreatment to the midtreatment assessment .


However , a significant group quadratic trend interaction ( d = -0.34 ) showed that the pattern of change in Davidson Trauma Scale significantly differed across groups .


The yoga group exhibited a significant medium effect size linear ( d = -0.52 ) trend .


In contrast , the control group exhibited only a significant medium effect size quadratic trend ( d = 0.46 ) but did not exhibit a significant linear trend ( d = -0.29 ) .


Thus , both groups exhibited significant decreases in PTSD symptoms during the first half of treatment , but these improvements were maintained in the yoga group , while the control group relapsed after its initial improvement .


Yoga significantly reduced PTSD symptomatology , with effect sizes comparable to well-researched psychotherapeutic and psychopharmacologic approaches .


Yoga may improve the functioning of traumatized individuals by helping them to tolerate physical and sensory experiences associated with fear and helplessness and to increase emotional awareness and affect tolerance .


ClinicalTrials.gov identifier : NCT00839813 .


Nausea and vomiting ( NV ) related to DMSO affect patients undergoing auto-SCT despite antiemetic measures .


Orange flavoring may reduce gastrointestinal symptoms .


A multicenter , randomized , three-arm , open-label trial in four Italian large bone marrow transplant centers was conducted to assess the effectiveness of orange aroma in preventing NV related to DMSO .


Patients were randomized to orange ice lollies , non-citrus ice lollies , and routine treatment ( deep breaths ) during reinfusion .


Data on NV were collected up to 5days after infusion ; 69/98 patients were randomized : 23 to orange , 21 to non-citrus ice lollies , and 25 to routine treatment .


Although 48h after transplantation no differences were observed in controlled nausea ( Numerical Rating Scale ( NRS ) 0-100 , 25 ) or vomiting , significantly fewer patients had no episodes of vomiting , no antiemetic rescue therapy , and no nausea ( NRS < 5 ) in the deep breath vs lollies groups ( P = 0.017 ) .


The intensity of nausea over time differed significantly between ice lollies vs routine care ( P = 0.001 ) groups , but not between the orange and non-citrus groups ( P = 0.428 ) .


The vasoconstrictive action of ice may prevent NV related to DMSO in the acute phase and reduce the need for rescue antiemetic therapy .


Ice lollies offer a simple , noninvasive , and economic means for relieving nausea and vomiting related to this preservative .


To compare the efficacy of the vaginal and sublingual administration of the synthetic prostaglandin misoprostol with the currently used oral administration route in second-trimester medical abortion .


This was a prospective randomized trial of medical abortion with misoprostol after mifepristone priming at 14-24 weeks of gestation .


From 2009 to 2013 , recruited women received 200 mg mifepristone orally followed 24-48 hours later by an 800-microgram vaginal loading dose of misoprostol .


Women were then randomized to receive additional 400-microgram misoprostol doses orally every 3 hours , vaginally every 4 hours , or sublingually every 3 hours .


The main outcome was the duration of abortion with emphasis on the proportion of women undelivered 12 hours after the misoprostol loading dose in the three groups .


A total of 302 women were randomized : 100 to oral , 100 to vaginal , and 102 to sublingual misoprostol .


The median gestation at recruitment was oral 19.1 weeks ( interquartile range 17.2-20 .8 ) , vaginal 19.4 weeks ( interquartile range 17.3-20 .4 ) , and sublingual 19.7 weeks ( interquartile range 17.6-21 .0 ) .


The overall abortion duration was longer in women receiving oral misoprostol : oral 9.5 hours ( 95 % confidence interval [ CI ] 8.5-11 .4 ) , vaginal 7.4 hours ( 95 % CI 6.5-8 .2 ) , and sublingual 7.8 hours ( 95 % CI 7.0-9 .2 ) .


Overall , 84 of 302 ( 27.8 % ) women were undelivered at 12 hours , comprising 37.0 % ( 95 % CI 28.7-47 .8 ) oral , 20.5 % ( 95 % CI 14.0-30 .1 ) vaginal , and 21.0 % ( 95 % CI 14.3-30 .7 ) sublingual groups .


Vaginal or sublingual misoprostol administered after a vaginal loading dose in second-trimester medical abortion with mifepristone priming is associated with a shorter time to pregnancy termination compared with an oral regimen .


ClinicalTrials.gov , www.clinicaltrials.gov , NCT00864799 .


I.


IPX066 , an investigational extended-release carbidopa-levodopa ( CD-LD ) preparation , has demonstrated a rapid attainment and prolonged maintenance of therapeutic LD plasma concentrations in advanced Parkinson 's disease ( PD ) .


This phase-3 crossover study assessed its efficacy and safety vs. CD-LD plus entacapone ( CL+E ) .


At baseline , all patients had motor fluctuations despite a stable regimen of CL+E or CD-LD-entacapone combination tablets ( CLE ) .


The study included a 6-week conversion from CL+E or CLE to IPX066 , followed by two 2-week , double-blind crossover treatment periods in randomized order , one on IPX066 ( and placebo CL+E ) , the other on CL+E ( and placebo IPX066 ) , separated by 1-week open-label IPX066 treatment .


The primary efficacy measure was mean percent daily `` off '' time during waking hours ( from patient diaries ) .


Of 91 randomized patients , 84 completed the study .


Their median daily LD dosage was 1495mg from IPX066 and 600mg from CL+E , corresponding , after correction for bioavailability , to an approximately 22 % higher LD exposure on IPX066 .


Compared with CL+E , IPX066 demonstrated a lower percent `` off '' time ( 24.0 % vs. 32.5 % ; p < 0.0001 ) , lower `` off '' time ( 3.8 vs. 5.2 h/day ; p < 0.0001 ) , and higher `` on '' time without troublesome dyskinesia ( 11.4 vs. 10.0 h/day ; p < 0.0001 ) .


Other endpoints , including patient-reported treatment preference , also favored IPX066 ( p < 0.05 ) .


During double-blind treatment , 20.2 % and 13.6 % of patients reported adverse events on IPX066 and CL+E , respectively .


The most common were dyskinesia ( 4 patients ) , insomnia ( 3 ) , and confusional state ( 3 ) for IPX066 , and fall ( 2 ) for CL+E .


In advanced PD , IPX066 showed improved efficacy , compared with CL+E , and appeared to be well tolerated .


To measure the psychosocial consequences in the Danish lung cancer screening trial ( DLCST ) and compare those between the computed tomography ( CT ) group and the control group .


This study was a single centre randomised controlled trial with five annual screening rounds .


Healthy current or former heavy smokers aged 50-70 years ( men and women ) were randomised 1:1 to a CT group and a control group .


Heavy smokers were defined by having smoked 20 pack years and former smokers by being abstinent 10 years .


Both groups were invited annually to the screening clinic to complete the validated lung-cancer-specific questionnaire consequences of screening lung cancer ( COS-LC ) .


The CT group was also offered a low dose CT scan of the lungs .


The COS-LC measures nine scales with psychosocial properties : Anxiety , Behaviour , Dejection , Negative impact on sleep , Self-blame , Focus on Airway Symptoms , Stigmatisation , Introvert , and Harm of Smoking .


4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5 % and 73.6 % , respectively .


There was a significant increase in negative psychosocial consequences from baseline through rounds 2-5 for both the CT group and the control group ( mean increase > 0 , p < .0001 for 3 of 4 possible scales ) .


During rounds 2-5 the control group experienced significantly more negative psychosocial consequences in seven of nine scales compared with the CT group ( mean score > 0 and p < .033 ) .


Lung cancer CT-screening trials induced more negative psychosocial reactions in both the CT group and the control group compared with the baseline psychosocial profile .


The CT group experienced less negative psychosocial consequences compared with the control group , which might be explained by reassurance among those with normal screening results .


ClinicalTrials.gov : NCT00496977 .


Maternal immunization with tetanus toxoid , reduced diphtheria toxoid , and acellular pertussis ( Tdap ) vaccine could prevent infant pertussis .


To evaluate the safety and immunogenicity of Tdap immunization during pregnancy and its effect on infant responses to diphtheria and tetanus toxoids and acellular pertussis ( DTaP ) vaccine .


Phase 1-2 , randomized , double-blind , placebo-controlled , clinical trial conducted from 2008 to 2012 .


Forty-eight pregnant women aged 18 to 45 years received Tdap ( n = 33 ) or placebo ( n = 15 ) at 30 to 32 weeks ' gestation , with crossover immunization postpartum .


Tdap vaccination at 30 to 32 weeks ' gestation or postpartum .


Primary outcomes were maternal and infant adverse events , pertussis illness , and infant growth and development until age 13 months .


Secondary outcomes were antibody concentrations in pregnant women before and 4 weeks after Tdap immunization or placebo , at delivery and 2 months ' postpartum , and in infants at birth , at 2 months , and after the third and fourth doses of DTaP .


No Tdap-associated serious adverse events occurred in women or infants .


Injection site reactions after Tdap immunization were reported in 26 ( 78.8 % [ 95 % CI , 61.1 % -91.0 % ] ) and 12 ( 80 % [ 95 % CI , 51.9 % -95.7 % ] ) pregnant and postpartum women , respectively ( P > .99 ) .


Systemic symptoms were reported in 12 ( 36.4 % [ 95 % CI , 20.4 % -54.9 % ] ) and 11 ( 73.3 % [ 95 % CI , 44.9 % -92.2 % ] ) pregnant and postpartum women , respectively ( P = .03 ) .


Growth and development were similar in both infant groups .


No cases of pertussis occurred .


Significantly higher concentrations of pertussis antibodies were measured at delivery in women who received Tdap during pregnancy vs postpartum ( eg , pertussis toxin antibodies : 51.0 EU/mL [ 95 % CI , 37.1-70 .1 ] and 9.1 EU/mL [ 95 % CI , 4.6-17 .8 ] , respectively ; P < .001 ) and in their infants at birth ( 68.8 EU/mL [ 95 % CI , 52.1-90 .8 ] and 14.0 EU/mL [ 95 % CI , 7.3-26 .9 ] , respectively ; P < .001 ) and at age 2 months ( 20.6 EU/mL [ 95 % CI , 14.4-29 .6 ] and 5.3 EU/mL [ 95 % CI , 3.0-9 .4 ] , respectively ; P < .001 ) .