To explore the effect of patient-controlled lumbar epidural combined anesthesia with Doula for labor analgesia with ropivacaine and sufentanil , and its influence on the progress of labor , and outcomes of mother and infant .


Two hundred parturients that requested labor analgesia were randomly selected by patient-controlled lumbar epidural combined anesthesia with Doula as the observation group , meanwhile another @ parturients were selected as the control group without any analgesic measurements .


Labor pain score , labor duration , blood gas analysis results , the incidence of cesarean section , neonatal asphyxia , and postpartum hemorrhage were compared between the two groups .


Compared with the control group , labor analgesic effect was remarkable , the cesarean section rate was significantly reduced in observation group , and the difference was statistically significant ( p < @ ) , but with respect to the duration of labor , maternal , postpartum hemorrhage , and neonatal asphyxia , there was no statistical significance between the two groups ( p > @ ) .


In the observation group regarding maternal and neonatal blood gas analysis results , PO@ was higher and PCO@ was lower than those in the control group .


The differences were statistically significant ( p < @ ) .


Labor analgesia by patient-controlled lumbar epidural combined anesthesia accompanied with Doula with ropivacaine and sufentanil is effective , safe , reliable , has no adverse effects , and reduces cesarean section rate .


Ventricular arrhythmias are common after acute myocardial infarction ( AMI ) .


Endothelin ( ET ) is a mediator of microvascular dysfunction and cardiac remodeling with arrhythmogenic potential .


The aim of this study was to assess safety and feasibility of selective ET-A receptor blockade in ST-elevation acute coronary syndrome ( STE-ACS ) within a larger randomized trial .


Patients with posterior-wall STE-ACS were randomly assigned to receive intravenous BQ-@ at @ nmol/min or placebo over @ min , starting immediately prior to primary percutaneous coronary intervention .


Twenty-four hour Holter recordings were performed during hospitalization for STE-ACS and after @-@ weeks .


The predefined primary endpoint was the documentation of ventricular tachycardia and/or late potentials at follow-up .


There was no significant difference in the predefined primary endpoint at @ ( @-@ ) days ( @/@ ( @ % ) in BQ-@ treated patients vs. @/@ ( @ % ) in the placebo group , p = @ ) .


At @ ( @-@ ) days , an increase in the total number of supraventricular extrasystoles ( SVES ) / @ h in patients randomized to BQ-@ ( @ ( @-@ ) beats vs. @ ( @-@ ) beats in placebo treated patients , p = @ ) occurred .


This increase was also observed at @ days ( @ ( @-@ ) beats vs. @ ( @-@ ) beats in placebo treated patients , p = @ ) .


There was no significant difference regarding other rhythmologic secondary endpoints between the two groups .


Based on the analysis of long-term ECG data , short-term administration of BQ-@ after AMI was safe .


Because of the small sample size , no firm conclusion regarding antiarrhythmic efficacy can be drawn .


Hypertension self-management has been shown to improve systolic blood pressure ( BP ) control , but longer-term economic and clinical impacts are unknown .


The purpose of this article is to examine clinical and economic outcomes @ months after completion of a hypertension self-management trial .


This study is a follow-up analysis of an @-month , @-arm , hypertension self-management trial of @ veterans with hypertension who were randomized to usual care or @ of @ interventions .


Clinic-derived systolic blood pressure obtained before , during , and after the trial were estimated using linear mixed models .


Inpatient admissions , outpatient expenditures , and total expenditures were estimated using generalized estimating equations .


The @ telephone-based interventions were nurse-administered health behavior promotion , provider-administered medication adjustments based on hypertension treatment guidelines , or a combination of both .


Intervention calls were triggered by home BP values transmitted via telemonitoring devices .


Clinical and economic outcomes were examined @ months before , @ months during , and @ months after trial completion .


Compared with usual care , patients randomized to the combined arm had greater improvement in proportion of BP control during and after the @-month trial and estimated proportion of BP control improved @ months after trial completion for patients in the behavioral and medication management arms .


Among the patients with inadequate baseline BP control , estimated mean systolic BP was significantly lower in the combined arm as compared with usual care during and after the @-month trial .


Utilization and expenditure trends were similar for patients in all @ arms .


Behavioral and medication management can generate systolic BP improvements that are sustained @ months after trial completion .


Melanocytic nevi ( MN ) are the most important simulants of melanoma .


Although acquired nevi are usually clinically stable , they may show abnormal clinical behavior .


This study assessed the histological changes and prognosis of acquired MN with changing clinical behavior in Egyptian patients .


The study included @ patients that were classified into two groups ; Group A included nevi with abnormal clinical presentation and Group B included clinically typical nevi .


Each group included @ patients with a predominance of female patients .


Abnormal clinical presentation in Group A included altered pigmentation ( @ % ) , rapid enlargement ( @ % ) , keratotic changes ( @ % ) , inflammation ( @ % ) , ulceration ( @ % ) , and hemorrhage ( @ % ) .


Typical histological features were significantly higher ( p = @ ) in Group B ( @ % ) compared with Group A ( @ % ) .


Atypical histological features were significantly higher ( p = @ ) in Group A , with higher numbers of ulcerative and altered pigmented nevi .


Malignant changes showed no significant difference ( p = @ ) between the two groups .


No relapse was recorded after excision of any lesion .


Among Egyptians , changing clinical behavior of MN may show histological atypia but low risk of malignant transformation .


Early excision and follow-up of ulcerative and altered pigmented nevi are recommended .


The GeparQuattro study showed that adding capecitabine or prolonging the duration of anthracycline-taxane-based neoadjuvant chemotherapy from @ to @ weeks did not increase pathological complete response ( pCR ) rates .


Trastuzumab-treated patients with HER@-positive disease showed a higher pCR rate than patients with HER@-negative disease treated with chemotherapy alone .


We here present disease-free ( DFS ) and overall survival ( OS ) analyses .


Patients ( n = @ ) with cT @ tumors , or negative hormone-receptor status , or positive hormone-receptor and clinically node-positive disease received four times epirubicin/cyclophosphamide and were thereafter randomly assigned to four times docetaxel ( Taxotere ) , or four times docetaxel/capecitabine over @ weeks , or four times docetaxel followed by capecitabine over @ weeks .


Patients with HER@-positive tumors received @ year of trastuzumab , starting with the first chemotherapy cycle .


Follow-up was available for a median of @ years .


Outcome was not improved for patients receiving capecitabine ( HR @ ; P = @ for DFS and HR @ ; P = @ for OS ) as well as for patients receiving @ weeks of chemotherapy ( HR @ ; P = @ for DFS and HR @ ; P = @ for OS ) .


Trastuzumab-treated patients with HER@-positive disease showed similar DFS ( P = @ ) but a significantly better adjusted OS ( P = @ ) when compared with patients with HER@-negative disease treated with chemotherapy alone .


Recorded long-term cardiac toxicity was low .


Long-term results , similar to the results of pCR , do not support the use of capecitabine in the neoadjuvant setting in addition to an anthracycline-taxane-based chemotherapy .


However , the results support previous data showing a benefit of trastuzumab as predicted by higher pCR rates .


This randomized controlled pilot trial was conducted to evaluate the clinical efficacy of massage therapy ( MT ) for relief of symptoms of gastroesophageal reflux disease ( GERD ) .


The hypothesis was that , when compared to infants who received nonmassage therapy , infants who received MT would display fewer GERD symptoms , greater weight gain , greater amount of sleep , lower cortisol levels before and after treatment , and lower daily ( area under the curve -LSB- AUC -RSB- ) cortisol secretion .


Participants were @ infants born at term , @-@ weeks of age at enrollment , healthy except for a diagnosis of GERD by their pediatrician , and with a score of at least @ on the Infant Gastroesophageal Reflux Questionnaire-Revised ( I-GERQ-R ) .


Infants were randomized to receive either MT or a nonmassage sham treatment in their homes for @ min twice a week for @ weeks .


Data collectors and parents were blind to study condition .


GERD symptoms decreased in both groups and weight increased .


Pretreatment salivary cortisol levels decreased significantly over time in the massage group while increasing in the nonmassage group .


Daily cortisol level also decreased in the massage group and increased in the nonmassage group , but the difference was not significant .


MT administered by a professional therapist did not affect symptoms of GERD differently than a sham treatment but did decrease infant stress as measured by cortisol .


Research focusing on stress reduction in infants with GERD and multimodal treatments addressing GERD symptoms may yield the most effective treatment .


Rotation of femoral components could be optimized to improve function and durability of the knee joint .


The purpose of the present study was to assess rotational alignment of femoral component comparing between CT-based , custom cutting blocks and the contemporary total knee arthroplasty , instrument technique .


The prospective control study of @ patients underwent total knee arthroplasty by using PFC Sigma PS total knee design .


Rotation offemoral component was analyzed in all patients using postoperative CT scan .


Forty patients were perfonned on by using CT-based , patient-specific cutting blocks with femoral rotational axis relative to transepicondylar axis while forty patients were performed on by using contemporaly instrumentation with alignment at @ degrees external rotation from posterior condylar line .


The rotation of the femoral component with external rotation ofmore than @ degrees or internal rotation was considered outlier .


There was no statistically significant difference among ages , gender ; BMI , pre-operative mechanical axis between the two groups .


There were eleven outliers in conventional group ( range , @ degrees ofexternal rotation to @ degrees of internal rotation ) , three femoral components were in excessive external rotation with the angle of more than @ degrees and eight femnoral components were in internal rotation .


In contrast with custom cutting block group was no outliers offemoral rotation .


The average rotational alignment was @ + / - @ external rotation from epicondylar axis in custom cutting group and @ + / - @ in contemporary group .


Custom cutting , block technique significantly reduced the outlier of the femoral component rotation and aided in positioning of the femoral component in optimal alignment .


The improvement of femoral rotation showed no difference in clinical outcome between the two groups .


The purpose of the study was to analyze the potential capacity of a dietary supplement , based on gamma linolenic acid , vitamin E , vitamin C , beta-carotene , coenzyme Q@ and Vitis Vitifera , to reduce side effects , in particular the dry skin , erythema and desquamation , due to treatment with oral isotretinoin , and evaluate the ability of the product to increase adherence to therapy in patients with acne .


Forty-eight patients with nodular acne ( @ females and @ males ) were randomly divided into @ groups : @ received isotretinoin therapy ( @-@ mg/day ) for @ months associated to dietary supplement ( twice a day ) , while the other @ patients received only isotretinoin ( @-@ mg/day ) for @ months .


For all patients the degree of acne severity , through GAGS ( Global Acne Grading System ) , the sebum production by Sebutape , the hydration by Corneometer and the erythema by Mexameter , were measured .


We have also evaluated the adherence to treatment , asking to patients how many days a week they follow the therapy .


Patients treated with dietary supplement had lower side effects , with a less degree of erythema and dryness , and greater degree of hydration ; a greater adherence to therapy was also reported .


Thanks to antioxidant and moisturizing properties , the dietary supplement containing gamma linolenic acid , vitamin E , vitamin C , betacarotene , coenzyme Q@ and Vitis Vitifera , can be considered a useful supplement in the treatment and prevention of dry skin associated with the use of oral isotretinoin .


Integrating antenatal care ( ANC ) and HIV care may improve uptake and retention in services along the prevention of mother-to-child transmission ( PMTCT ) cascade .


This study aimed to determine whether integration of HIV services into ANC settings improves PMTCT service utilization outcomes .


ANC clinics in rural Kenya were randomized to integrated ( @ clinics , @ women ) or nonintegrated ( @ clinics , @ women ) services .


Intervention clinics provided all HIV services , including highly active antiretroviral therapy ( HAART ) , whereas control clinics provided PMTCT services but referred women to HIV care clinics within the same facility .


PMTCT utilization outcomes among HIV-infected women ( maternal HIV care enrollment , HAART initiation , and @-month infant HIV testing uptake ) were compared using generalized estimating equations and Cox regression .


HIV care enrollment was higher in intervention compared with control clinics -LSB- @ % versus @ % ; odds ratio = @ , @ % confidence interval ( CI ) : @ to @ -RSB- .


Median time to enrollment was significantly shorter among intervention arm women ( @ versus @ days , hazard ratio = @ , @ % CI : @ to @ ) .


Eligible women in the intervention arm were more likely to initiate HAART ( @ % versus @ % ; odds ratio = @ , @ % CI : @ to @ ) .


Infant testing was more common in the intervention arm ( @ % versus @ % ) , however , not statistically different .


No significant differences were detected in postnatal service uptake or maternal retention .


Service integration increased maternal HIV care enrollment and HAART uptake .


However , PMTCT utilization outcomes were still suboptimal , and postnatal service utilization remained poor in both study arms .


Further improvements in the PMTCT cascade will require additional research and interventions .


The use of @-alpha-hydroxyprogesterone caproate ( @P ) has been shown to reduce preterm delivery in women who have had a prior preterm birth .


The role of @P in women with arrested preterm labor is less certain .


To compare the preterm birth rate and neonatal outcome in women with arrested preterm labor randomized to receive @P or placebo .


Women with arrested preterm labor were randomized to weekly injections of either @P ( @mg ) or placebo .


Maternal and neonatal outcome were evaluated .


Forty-five singleton pregnancies were randomized after successful tocolysis ; @ received @P while @ got placebo .


Gestational age at delivery ( p = @ ) and the interval from treatment to delivery ( p = @ ) were not affected by @P .


Significantly less women in the @P group delivered at < @ weeks ( @ versus @ , p = @ ) .


There was also a significant reduction in the risk of neonatal sepsis ( p = @ ) and gr III/IV intraventricular hemorrhage ( IVH ) ( p = @ ) in the @P group .


In this study , @P did not delay the interval to delivery after successful preterm labor , but births < @ weeks as well as neonatal sepsis and IVH were reduced by @P treatment .


Responses with greater amplitude were recorded when carrier frequencies were modulated at @ , @ , and @ Hz .


These responses can be recorded even in patients with significant sensorineural hearing loss , from the sternocleidomastoid ( SCM ) muscle for a @ Hz tone , @ % modulated at @ Hz .


To determine the best carrier and modulating frequencies to evoke steady-state myogenic responses .


The present study investigated @ ears of @ normal-hearing young adults , with carrier frequencies of @ , @ , and @ Hz , modulated at @ , @ , @ , @ , @ , @ , and @ Hz , with an intensity of @ dBA .


Furthermore , we observed responses evoked by stimulus carrier frequency of @ Hz , modulated at @ Hz , with an intensity of @ dBA in a group of five subjects with severe sensorineural loss .


Responses were found for all stimuli studied ( p < @ ) .


Modulated stimuli at frequencies of @ , @ , and @ Hz evoked better steady-state vestibular evoked myogenic potential ( S-VEMP ) ( p < @ ) .


No statistically significant differences were found between the group of normal hearers and the group of subjects with hearing loss ( p = @ ) , for the stimulus used .


To examine the effects of a ten week deadlift training program on peak torque and agonist-antagonist coactivation .


Fifty-four untrained subjects ( mean age = @ years ) participated in this investigation , and were randomly assigned to a training ( males , n = @ ; females , n = @ ) or control ( males , n = @ ; females , n = @ ) group .


The subjects in the training group performed deadlifts twice per week .


Isometric peak torque for the leg extensors and flexors and surface electromyographic ( EMG ) amplitude for the superficial quadriceps and biceps femoris muscles were assessed .


Deadlift training increased leg extension peak torque for the males ( P = @ , Cohen 's d = @ ) and females ( P = @ , d = @ ) .


Leg flexion peak torque improved for the females ( P = @ , d = @ ) .


Increased EMG amplitude for the superficial quadriceps femoris muscles when they served as agonists was demonstrated for the females ( P = @ , d = @ ) , but not the males ( P = @ , d = @ ) .


For both sexes , the effect sizes for the decline in biceps femoris coactivation were large .


Deadlift training elicited improvements in strength and agonist-antagonist coactivation in untrained subjects , and particularly , novice females .


Kisspeptin-@ , an endogenous naturally occurring ligand of the G protein-coupled receptor-@ , stimulates GnRH-gonadotropin secretion and suppresses metastases in animal models of cancer but is subject to rapid degradation and inactivation .


TAK-@ is an investigational oligopeptide analog of the fully active @-amino acid C terminus of kisspeptin-@ .


This phase @ study evaluated the safety , pharmacokinetics , and pharmacodynamics of TAK-@ in healthy subjects and patients with prostate cancer ( PC ) .


Healthy subjects aged @ years or older received TAK-@ sc as a single-bolus or @-hour infusion ( @-@ mg/d ; part A ) and as a @-day sc administration ( @-@ mg/d ; part B ) .


In a subsequent , open-label , phase @ study in PC patients aged @-@ years , TAK-@ was given as a @-month depot formulation .


Eighty-two healthy subjects received TAK-@ ; @ received placebo .


Grades @-@ adverse events were reported in @ % of subjects during TAK-@ treatment .


All dosing regimens resulted in dose-proportional exposures .


The maximum observed plasma concentration occurred after @-@ @ hours , and median terminal elimination half-life was @-@ @ hours .


T increased approximately @ - to @-fold by @ hours after a single bolus or @ hour injections , whereas during the @-day infusion , at doses above @ mg/d , T dropped to below-baseline values by @ hours and reached a subsequently sustained below-castration level by day @ .


In PC patients , T decreased to less than @ ng/dL in four of five patients dosed with @ or @ mg TAK-@ sc-depot injections .


The prostate-specific antigen decreased greater than @ % in all patients dosed with @ mg .


Continuous TAK-@ infusion was well tolerated by healthy males and resulted in sustained T suppression .


Depot injection in patients with PC similarly reduced T and resulted in prostate-specific antigen responses .


To evaluate the clinical efficacy , safety , and costs of percutaneous occlusive balloon catheter-assisted ureteroscopic lithotripsy ( POBC-URSL ) for large impacted proximal ureteral calculi .


@ patients with impacted proximal ureteral stones @ cm in size were randomized to ureteroscopic lithotripsy ( URSL ) , POBC-URSL , and percutaneous nephrolithotomy ( PNL ) group between May @ and May @ .


For URSL , the calculi were disintegrated with the assistance of anti-retropulsion devices .


POBC-URSL was performed with the assistance of an @F percutaneous occlusive balloon catheter .


PNL was finished with the combination of an ultrasonic and a pneumatic lithotripter .


A flexible ureteroscope and a @m laser fiber were used to achieve stone-free status to a large extent for each group .


Variables studied were mean operative time , auxiliary procedure , postoperative hospital stay , operation-related complications , stone clearance rate , and treatment costs .


The mean lithotripsy time for POBC-URSL was shorter than URSL , but longer than PNL ( @ minutes vs @ minutes vs @ minutes , p = @ ) .


The auxiliary procedure rate and postoperative fever rate for POBC-URSL were significantly lower than URSL and comparable to PNL ( p < @ , p = @ ) .


POBC-URSL was superior to URSL with regard to the stone clearance rate at @ days postoperatively , and as good as PNL ( @ % vs @ % vs @ % , p < @ ) .


The postoperative hospital stay and hematuria rate were lower in POBC-URSL group than PNL group and similar to URSL group ( p = @ , p < @ ) .


The treatment costs were lowest in POBC-URSL group ( $ @ $ @ vs $ @ $ @ vs $ @ $ @ , p = @ ) .


For large impacted proximal ureteral calculi , POBC-URSL was associated with a higher stone clearance rate , fewer complications and costs .


POBC-URSL combined the advantages of URSL and PNL .


To evaluate the effect of vaginal misoprostol on intraoperative bleeding during myomectomy .


In this randomized clinical trial , @ women with myomas were randomly assigned to receive @ g misoprostol or placebo ( vitamin B@ ) @ h before surgery .


Blood loss during surgery , postoperative need for blood transfusion , and the hemoglobin level before surgery , and @ and @ h after surgery were assessed in two groups .


Mean age and the mean preoperative and postoperative Hb levels were not significantly different between the two groups .


Mean duration of surgery and mean estimated blood loss were significantly higher in control group .


Nine ( @ % ) patients in control group needed blood transfusion while there was no need blood transfusion in misoprostol group ( p = @ ) .


A single dose of vaginal misoprostol is effective in reducing hemorrhage during myomectomy .


Hepatitis C virus ( HCV ) infection is an important cause of liver cancer in Thailand .


The highest prevalence of anti-HCV positive among Thai blood donors is found in the northeastern region .


The present analysis of the genotype distribution among anti-HCV positive northeastern-Thai blood donors was conducted to provide a base for the epidemiological pattern of HCV infection in this region .


A total of @ HCV seropositive healthy blood donors were randomly selected and tested for the presence of HCV-RNA by RT-PCR .


HCV-RNA positive samples were genotyped by direct sequencing at core region genomes and confirmed by phylogenetic analysis .


HCV viremia was found in @ % ( @/@ ) of HCV seropositive blood donors .


There were @ major genotypes distributed among this population .


HCV genotype @a was the most prevalent ( @ % ) followed by genotypes @a ( @ % ) , @b ( @ % ) , @i ( @ % ) , @f ( @ % ) and @n ( @ % ) .


HCV genotype @a in asymptomatic infections in northeastern Thailand is significantly higher than other previous reports .


Subgenotype @ prevalence is less than in neighboring countries and distribution patterns differ .


The findings are relevant as predictors for using interferon therapy in this population .


Many bacterial pathogens causing respiratory infections in children are common residents of the respiratory tract .


Insight into bacterial colonization patterns and microbiota stability at a young age might elucidate healthy or susceptible conditions for development of respiratory disease .


To study bacterial succession of the respiratory microbiota in the first @ years of life and its relation to respiratory health characteristics .


Upper respiratory microbiota profiles of @ healthy children at the ages of @ , @ , @ , and @ months were characterized by @S-based pyrosequencing .


We determined consecutive microbiota profiles by machine-learning algorithms and validated the findings cross-sectionally in an additional cohort of @ children per age group .


Overall , we identified eight distinct microbiota profiles in the upper respiratory tract of healthy infants .


Profiles could already be identified at @ months of age and were associated with microbiota stability and change over the first @ years of life .


More stable patterns were marked by early presence and high abundance of Moraxella and Corynebacterium/Dolosigranulum and were positively associated with breastfeeding in the first period of life and with lower rates of parental-reported respiratory infections in the consecutive periods .


Less stable profiles were marked by high abundance of Haemophilus or Streptococcus .


These findings provide novel insights into microbial succession in the respiratory tract in infancy and link early-life profiles to microbiota stability and respiratory health characteristics .


New prospective studies should elucidate potential implications of our findings for early diagnosis and prevention of respiratory infections .


Clinical trial registered with www.clinicaltrials.gov ( NCT@ ) .


To compare the difference in the efficacy on gait time cycle of ischemic stroke between yin-yang respiratory reinforcing and reducing needling technique ( yin-yang needling ) and the conventional acupuncture .


Sixty cases of ischemic stroke were randomized into a conventional acupuncture group and a yin-yang needling group , @ cases in each one .


The basic treatment ( the control of blood pressure , blood sugar and blood lipid , the intravenous drops of ginkgo leaf extract and dipyridamole injection and vinpocetine injection ) were applied in the two groups .


Additionally , in the conventional acupuncture group , the acupoints of the Stomach Meridian of Foot-Yangming -LSB- Biguan ( ST @ ) , Liangqiu ( ST @ ) , Zusanli ( ST @ ) , Shangjuxu ( ST @ ) , Xiajuxu ( ST @ ) , etc. -RSB- were selected and stimulated with the even needling technique .


In the yin-yang needling group , the acupoints of yin meridians such as Zuwuli ( LR @ ) , Xuehai ( SP @ ) , Yinlingquan ( SP @ ) and Sanyinjiao ( SP @ ) , etc. and the acupoints of yang meridians such as Biguan ( ST @ ) , Liangqiu ( ST @ ) and Yanglingquan ( GB @ ) , etc. were selected .


The reducing manipulation of respiratory reinforcing and reducing technique was applied to the acupoints of yin meridians and the reinforcing manipulation was applied to the acupoints of yang meridians .


The kinematics time parameters were determined and compared before and @ weeks after treatment .


After treatment , the differences in the gait cycle , the phase time of standing ( % ) , the phase time of single support ( % ) , the phase time of unilateral sway ( % ) on the affected ( healthy ) foot and phase time of double support ( % ) were significant as compared with those before treatment in the patients of the two groups ( all P < @ ) , in which , the gait cycle ( @ + / - @ vs @ + / - @ ) , the phase time of standing ( % ) on the affected ( healthy ) foot -LSB- ( @ + / - @ ) % vs ( @ + / - @ ) % , ( @ + / - @ ) % vs ( @ + / - @ ) % -RSB- , the phase time of unilateral sway ( % ) on the affected ( healthy ) foot -LSB- ( @ + / - @ ) % vs ( @ + / - @ ) % , ( @ + / - @ ) % vs ( @ + / - @ ) % -RSB- and the phase time of double support ( % ) -LSB- ( @ + / - @ ) % vs ( @ + / - @ ) % -RSB- in the yin-yang needling group were improved much obviously after treatment as compared with those in the conventional acupuncture group .


The differences in support phase time ( % ) , single support phase time ( % ) and sway phase time ( % ) were significant between the affected limb and healthy limb of the two groups after treatment ( all P < @ ) .


Yin-yang respiratory reinforcing and reducing needling technique effectively improves hemiplegic gait movement cycle and walking function in patients of ischemic stroke , which is superior to the conventional acupuncture treatment .


Biofeedback is a self-regulation therapy by which the patient learns how to optimize the functioning of his autonomic nervous system .


It has been applied to patients with various cardiovascular disorders .


The purpose of this study was to investigate the practical feasibility and the psychophysiological effects of biofeedback applied to heart rate variability ( HRV biofeedback ) in order to increase cardiac coherence in coronary artery disease ( CAD ) patients participating in a cardiac rehabilitation programme .


In this randomised and controlled study , @ CAD patients were randomly assigned to an experimental or to a control group .


The experimental group participated in a programme of @ sessions of cardiac coherence biofeedback training , in addition to the rehabilitation programme .


The control group participated in the usual cardiac rehabilitation programme only .


Physiological variables ( systolic and diastolic blood pressure , SDNN ) and psychosocial variables ( anxiety , depression , type D personality ) were measured at the start and at the end of the programme in both groups .


Statistical comparisons assessed the inter and intra group differences .


The small sample size precludes any firm conclusions concerning the effect of cardiac coherence biofeedback on physiological or psychological variables .


However , we observed a significant increase of the percentage of cardiac coherence , in relation with an increased SDNN index .


Our study demonstrated the practical feasibility of cardiac coherence biofeedback training in CAD patients .


Further research is desirable to investigate the potential benefit of cardiac coherence biofeedback as an adjunct to stress management in cardiac rehabilitation .


Each year approximately @ patients in the United Kingdom undergo surgery for esophagogastric cancer .


Jejunostomy feeding tubes , placed at the time of surgery for early postoperative nutrition , have been shown to have a positive impact on clinical outcomes in the short term .


Whether feeding out of hospital is of benefit is unknown .


Local experience has identified that between @ and @ % of patients required ` rescue ' jejunostomy feeding for nutritional problems and weight loss while at home .


This weight loss and poor nutrition may contribute to the detrimental effect on the overall quality of life ( QoL ) reported in these patients .


This randomized pilot and feasibility study will provide preliminary information on the routine use of jejunostomy feeding after hospital discharge in terms of clinical benefits and QoL .


Sixty participants undergoing esophagectomy or total gastrectomy will be randomized to receive either a planned program of six weeks of home jejunostomy feeding after discharge from hospital ( intervention ) or treatment-as-usual ( control ) .


The intention of this study is to inform a multi-centre randomized controlled trial .


The primary outcome measures will be recruitment and retention rates at six weeks and six months .


Secondary outcome measures will include disease specific and general QoL measures , nutritional parameters , total and oral nutritional intake , hospital readmission rates , and estimates of healthcare costs .


Up to @ participants will also be enrolled in a qualitative sub-study that will explore participants ' and carers ' experiences of home tube feeding.The results will be disseminated by presentation at surgical , gastroenterological and dietetic meetings and publication in appropriate peer review journals .


A patient-friendly lay summary will be made available on the University of Leicester and the University Hospitals of Leicester NHS Trust websites .


The study has full ethical and institutional approval and started recruitment in July @ .


To investigate whether the neural representations underlying alternating two acupoint combinations ( ACs ) are the same or not .


In this functional magnetic resonance imaging study , two sets of analgesia ACs were utilized , including Waiguan ( TE@ ) and Qiuxu ( GB@ ) for Group A , and Neiguan ( PC@ ) and Taichong ( LR@ ) for Group B , which are the most commonly adopted in clinical treatment .


Each group had @ healthy subjects .


An experimental design was proposed , which consisted of a pre-needling resting phase , a needling phase and a post-needling resting phase .


This paradigm optimally mimics the clinical protocol as well as focuses on both the stimulation and the resting periods .


The results were subjected to general linear model analysis , conjunction analysis and the functional connectivity analysis .


The rostral anterior cingulated cortex was engaged in the initiative period of the acupuncture effect in both groups , and it was chosen as the seed region for the functional connectivity analysis for the following resting period .


The results showed that several shared brain regions were involved in both groups , in particular the insula , amygdala and hypothalamus .


Moreover , significant differences were located at the posterior cingulated cortex as revealed by a two sample - test ( P < @ , corrected ) .


Other regions showed no significant differences .


This finding was further supported by the spatial correlation analysis that the two groups were significantly correlated ( r = @ , P < @ ) .


This preliminary research helps us understand the neurophysiological mechanisms of acupuncture when following clinical guidelines on ACs , as well as provides an important opportunity to develop better treatment strategies for reducing , or even preventing pain .


To assess whether a dementia care coordination intervention delays time to transition from home and reduces unmet needs in elders with memory disorders .


@-month randomized controlled trial of @ community-living elders .


@ postal code areas of Baltimore , MD. .


Age @ + years , with a cognitive disorder , community-living , English-speaking , and having a study partner available .


@-month care coordination intervention to systematically identify and address dementia-related care needs through individualized care planning ; referral and linkage to services ; provision of dementia education and skill-building strategies ; and care monitoring by an interdisciplinary team .


Primary outcomes were time to transfer from home and total percent of unmet care needs at @months .


Intervention participants had a significant delay in time to all-cause transition from home and the adjusted hazard of leaving the home was decreased by @ % ( Hazard ratio : @ , @ % Confidence Interval : @-@ @ ) compared with control participants .


Although there was no significant group difference in reduction of total percent of unmet needs from baseline to @ months , the intervention group had significant reductions in the proportion of unmet needs in safety and legal/advance care domains relative to controls .


Intervention participants had a significant improvement in self-reported quality of life ( QOL ) relative to control participants .


No group differences were found in proxy-rated QOL , neuropsychiatric symptoms , or depression .


A home-based dementia care coordination intervention delivered by non-clinical community workers trained and overseen by geriatric clinicians led to delays in transition from home , reduced unmet needs , and improved self-reported QOL .


This study investigated long-term effects and implementation processes of workplace strength training for musculoskeletal disorders .


@ and @ laboratory technicians from private and public sector companies , respectively , replied to a @-year follow-up questionnaire subsequent to a @-year randomized controlled trial ( RCT ) with high-intensity strength training for prevention and treatment of neck , shoulder , and arm pain .


Being a natural experiment , the two participating companies implemented and modified the initial training program in different ways during the subsequent @ years after the RCT .


At @-year follow-up the pain reduction in neck , shoulder , elbow , and wrist achieved during the first year was largely maintained at both companies .


However , the private sector company was rated significantly better than the public sector company in ( @ ) training adherence , ( @ ) training culture , that is , relatively more employees trained at the workplace and with colleagues , ( @ ) self-reported health changes , and ( @ ) prevention of neck and wrist pain development among initially pain-free employees .


This natural experiment shows that strength training can be implemented successfully at different companies during working hours on a long-term basis with lasting effects on pain in neck , shoulder , and arm .


This double-blind , randomized controlled trial aimed to investigate inhaled budesonide and oral dexamethasone compared with placebo for their prophylactic efficacy against acute mountain sickness after acute high-altitude exposure .


There were @ healthy young male lowland residents recruited and randomly assigned to receive inhaled budesonide ( @ g , twice a day -LSB- bid -RSB- ) , oral dexamethasone ( @ mg , bid ) , or placebo ( @ in each group ) .


They traveled to @ m altitude from @ m by car .


Medication started @ day before high-altitude exposure and continued until the third day of exposure .


Primary outcome measure was the incidence of acute mountain sickness after exposure .


One hundred twenty-four subjects completed the study ( @ , @ , and @ in the budesonide , dexamethasone , and placebo groups , respectively ) .


Demographic characteristics were comparable among the @ groups .


After high-altitude exposure , significantly fewer participants in the budesonide ( @ % ) and dexamethasone ( @ % ) groups developed acute mountain sickness compared with participants receiving placebo ( @ % ) ( P = @ and P = @ , respectively ) .


Both the budesonide and dexamethasone groups had lower heart rate and higher pulse oxygen saturation ( SpO@ ) than the placebo group at altitude .


Only the budesonide group demonstrated less deterioration in forced vital capacity and sleep quality than the placebo group .


Four subjects in the dexamethasone group reported adverse reactions .


Both inhaled budesonide ( @ g , bid ) and oral dexamethasone ( @ mg , bid ) were effective for the prevention of acute mountain sickness , especially its severe form , compared with placebo .


Budesonide caused fewer adverse reactions than dexamethasone .


To evaluate heart rate variability ( HRV ) , hemodynamics , mechanics , dyspnea and blood gases following different mechanical ventilation ( MV ) settings .


No study has evaluated physiological changes during T-piece trials following different MV settings .


In @ COPD patients on prolonged MV we applied in random order two MV settings : i ) pressure support ( PS ) @ cm H@O + positive end-expiratory pressure ( PEEP ) @ cm H@O ( setting-@ ) and ii ) PS @ cm H@O + PEEP @ cm H@O ( setting-@ ) , each followed by a @ min T-piece trial .


Setting-@ induced greater minute ventilation , tidal volume/inspiratory time and lower pulmonary artery occlusion pressure ; setting-@ reduced intrinsic PEEP .


Mechanics and hemodynamics data did not differ , but all HRV time domain indices were reduced only after setting-@ , suggesting a decreased parasympathetic and increased sympathetic cardiac modulation .


The T-piece trial following setting-@ seems less stressful on neural control of HRV .


Future studies on T-piece trials should consider the residual effect of the MV setting .


There is a gap in the literature regarding learning outcomes linked to the use of high-fidelity simulators compared to that of traditional teaching methods .


To examine the effect of using high-fidelity simulators on knowledge and skills acquisition and retention with university students .


A randomized two-arm trial using two different educational approaches on @ nursing students assigned randomly to two groups was used at two points of time .


The results showed significant differences in favor of the participants in the high-fidelity simulator group on both the acquisition and retention of knowledge and skills over time .


However , a significant loss of cardiopulmonary resuscitation knowledge and skills occurred at @ months after training in both groups .


The findings of this study may assist educators in integrating high-fidelity simulators in education and training .


In addition , the findings may help nursing educators to arrange additional cardiopulmonary resuscitation training sessions in order to improve cardiac arrested patients ' outcomes .


High-fidelity simulation ( HFS ) provides students with interactive learning experiences in a safe controlled environment .


HFS enables teachers to implement critical clinical scenarios , such as cardiac arrest , without risk to patients .


Integrating the simulation training into nursing curricula will help to overcome the challenges that face many courses , specifically the shortage of clinical areas for training and the increase in numbers of nursing students .


To evaluate weekly subcutaneous albiglutide versus daily sitagliptin in renally impaired patients with type @ diabetes and inadequately controlled glycemia on a regimen of diet and exercise and/or oral antihyperglycemic medications .


In this phase III , randomized , double-blind , multicenter , @-week study , the primary study end point was HbA@c change from baseline at week @ in patients with renal impairment , as assessed with estimated glomerular filtration rate and categorized as mild , moderate , or severe ( @ to @ , @ to @ , and @ to @ mL/min/@ @ m ( @ ) , respectively ) .


Secondary end points included fasting plasma glucose ( FPG ) , weight , achievement of treatment targets , hyperglycemic rescue , and safety .


Baseline demographics were similar across treatment and renal impairment groups with overall mean age of @ years , BMI of @ kg/m ( @ ) , HbA@c of @ % ( @ mmol/mol ) , and diabetes disease duration of @ years .


HbA@c change from baseline at week @ was significantly greater for albiglutide than sitagliptin ( -@ % vs. -@ % , P = @ ) .


Decreases in HbA@c , FPG , and weight were seen through week @ .


Time to hyperglycemic rescue through week @ was significantly longer for albiglutide than sitagliptin ( P = @ ) .


Results of safety assessments were similar between groups , and most adverse events ( AEs ) were mild or moderate .


The incidences of gastrointestinal AEs for albiglutide and sitagliptin were as follows : overall , @ % , @ % ; diarrhea , @ % , @ % ; nausea , @ % , @ % ; and vomiting , @ % , @ % , respectively .


Once-weekly albiglutide therapy in renally impaired patients with type @ diabetes provided statistically superior glycemic improvement with almost similar tolerability compared with daily sitagliptin therapy .


Antihypertensive drugs are used to control blood pressure ( BP ) and reduce macro - and microvascular complications in hypertensive patients with diabetes .


The present study aimed to compare the functional vascular changes in hypertensive patients with type @ diabetes mellitus after @ weeks of treatment with amlodipine or losartan .


Patients with a previous diagnosis of hypertension and type @ diabetes mellitus were randomly divided into @ groups and evaluated after @ weeks of treatment with amlodipine ( @ mg/day ) or losartan ( @ mg/day ) .


Patient evaluation included BP measurement , ambulatory BP monitoring , and assessment of vascular parameters using applanation tonometry , pulse wave velocity ( PWV ) , and flow-mediated dilation ( FMD ) of the brachial artery .


A total of @ patients were evaluated ( @ in each group ) , with a predominance of women ( @ % ) in both groups .


The mean age of the patients in both groups was similar ( amlodipine group : @ @ years ; losartan group : @ @ years ) , with no significant difference in the mean BP -LSB- amlodipine group : @ @ mmHg ( systolic ) and @ @ mmHg ( diastolic ) ; losartan group : @ @ mmHg ( systolic ) and @ @ mmHg ( diastolic ) -RSB- .


The augmentation index ( @ % @ % and @ % @ % , p = @ ) and augmentation pressure ( @ @ mmHg and @ @ mmHg , p = @ ) were lower in the amlodipine group when compared with the losartan group .


PWV and FMD were similar in both groups .


Hypertensive patients with type @ diabetes mellitus treated with amlodipine exhibited an improved pattern of pulse wave reflection in comparison with those treated with losartan .


However , the use of losartan may be associated with independent vascular reactivity to the pressor effect .


The objective of the current study was to evaluate the efficacy of aminaphtone to control gum bleeding .


Fifteen male and @ female children , aged between @ and @ years with a mean age of @ years and with gingival bleeding , were enrolled in this randomized , double-blind , placebo-controlled , Phase IV clinical trial .


The inclusion criterion was gingivitis with gingival bleeding .


Participants were prescribed either aminaphtone or placebo .


Thirty identical boxes containing blister packs of identical pills of either aminaphtone or placebo were produced and coded with unique numbers by the manufacturer ( Baldacci Laboratory , Brazil ) and donated for this trial .


A research assistant administered aminaphtone ( Capilarema @ mg ) to fifteen patients or placebo to fifteen patients twice daily for @ days .


Intraoral clinical evaluations of bleeding were made before starting medication/placebo and then at @ and @ days after administration .


On comparing the number of bleeding points before and after treatment between the aminaphtone and placebo groups , we found significantly higher reductions with the medication ( P < @ ) .


Aminaphtone reduces gum bleeding in gingivitis , and may have a supportive role in the control of bleeding .


Magnetic resonance perfusion ( MRP ) and computed tomographic perfusion ( CTP ) are being increasingly applied in acute stroke trials and clinical practice , yet the comparability of their perfusion values is not well validated .


The aim of this study was to validate the comparability of CTP and MRP measures .


A @-step approach was used .


Step @ was a derivation step , where we analyzed @ patients with acute ischemic stroke who had both CTP and MRP performed within @ hours of each other and within @ hours of stroke onset .


In this step , we derived the optimal perfusion map with the least difference between MRP and CTP .


In step @ , the optimal map was validated on whole-brain perfusion data of @ patients .


Step @ was to apply the optimal perfusion map to define cross-modality reperfusion from acute CTP to @-hour MRP in @ patients and , in turn , to assess how accurately this predicted @-month clinical outcome .


Among @ different perfusion maps included in this study , time to peak of the residual function ( T ( max ) ) was the only one with a nonsignificant difference between CTP and MRP in delineating perfusion defects .


This was validated on whole-brain perfusion data , showing high concordance of T ( max ) between the @ modalities ( concordance correlation coefficient of Lin , > @ ) ; the best concordance was at @ s.


At T ( max ) > @ s threshold , MRP and CTP reached substantial agreement in mismatch classification ( > @ ) .


Cross-modality reperfusion calculated by T ( max ) > @ s strongly predicted good functional outcome at @ months ( area under the curve , @ ; P < @ ) .


MRP and CTP can be used interchangeably if one uses T ( max ) measurement .


Previous studies have demonstrated that oxidative stress by mediating the excessive production of reactive oxygen species is involved in tissue damage and organ failure during and after surgery .


The impact of the preoperative immunonutrition including antioxidants on the postoperative course of patients undergoing hepatic surgery was investigated in this pilot study .


Twenty-three living donor liver transplantation ( LDLT ) donors were randomly assigned to either an experimental ( AO ) group , received a commercial supplement enriched with antioxidant nutrients for each of the @ days immediately prior to surgery while maintaining normal food intake , or a control ( CT ) group , administered no supplement .


Antioxidative capacity was measured by spectrophotometry of patient serum using a free-radical analytical system .


The antioxidative capacity of @ % patients in the AO group increased after immunonutrition .


Compared to the CT group , the AO group was found to have higher antioxidant capacity and transferrin levels ; lower WBC , lymphocyte , and neutrophil counts ; and briefer duration of postoperative fever during the postsurgical period .


No significant differences were found between the @ groups regarding the nutritional parameters ; liver functioning parameters ; immunological parameters ; intraoperative factors ; postoperative outcomes .


Preoperative immunonutrition including antioxidants might play a beneficial role in improving postsurgical immunological response but the modest biological advantage was not associated with any significant clinical outcome .


The RITA-@ ( Third Randomised Intervention Treatment of Angina ) trial compared outcomes of a routine early invasive strategy ( coronary arteriography and myocardial revascularization , as clinically indicated ) to those of a selective invasive strategy ( coronary arteriography for recurrent ischemia only ) in patients with non-ST-segment elevation acute coronary syndrome ( NSTEACS ) .


At a median of @ years ' follow-up , the routine invasive strategy was associated with a @ % reduction in the odds of all-cause mortality .


This study reports @-year follow-up outcomes of the randomized cohort to determine the impact of a routine invasive strategy on longer-term mortality .


We randomized @,@ patients with NSTEACS to receive routine invasive or selective invasive strategies .


All randomized patients had annual follow-up visits up to @ years , and mortality was documented thereafter using data from the Office of National Statistics .


Over @ years , there were no differences in mortality between the @ groups ( all-cause deaths in @ -LSB- @ % -RSB- vs. @ patients -LSB- @ % -RSB- : p = @ ; and cardiovascular deaths in @ -LSB- @ % -RSB- vs. @ patients -LSB- @ % -RSB- : p = @ in the routine invasive and selective invasive groups , respectively ) .


Multivariate analysis identified several independent predictors of @-year mortality : age , previous myocardial infarction , heart failure , smoking status , diabetes , heart rate , and ST-segment depression .


A modified post-discharge Global Registry of Acute Coronary Events ( GRACE ) score was used to calculate an individual risk score for each patient and to form low-risk , medium-risk , and high-risk groups .


Risk of death within @ years varied markedly from @ % in the low-risk group to @ % in the high-risk group .


This mortality trend did not depend on the assigned treatment strategy .


The advantage of reduced mortality of routine early invasive strategy seen at @ years was attenuated during later follow-up , with no evidence of a difference in outcome at @ years .


Further trials of contemporary intervention strategies in patients with NSTEACS are warranted .


( Third Randomised Intervention Treatment of Angina trial -LSB- RITA-@ -RSB- ; ISRCTN@ ) .


Communication about end-of-life care is a core clinical skill .


Simulation-based training improves skill acquisition , but effects on patient-reported outcomes are unknown .


To assess the effects of a communication skills intervention for internal medicine and nurse practitioner trainees on patient - and family-reported outcomes .


Randomized trial conducted with @ internal medicine and @ nurse practitioner trainees between @ and @ at the University of Washington and Medical University of South Carolina .


Participants were randomized to an @-session , simulation-based , communication skills intervention ( N = @ ) or usual education ( N = @ ) .


Primary outcome was patient-reported quality of communication ( QOC ; mean rating of @ items rated from @-@ , with @ = poor and @ = perfect ) .


Secondary outcomes were patient-reported quality of end-of-life care ( QEOLC ; mean rating of @ items rated from @-@ ) and depressive symptoms ( assessed using the @-item Personal Health Questionnaire -LSB- PHQ-@ -RSB- ; range , @-@ , higher scores worse ) and family-reported QOC and QEOLC .


Analyses were clustered by trainee .


There were @ patient ratings ( @ % response ) and @ family ratings ( @ % response ) .


The intervention was not associated with significant changes in QOC or QEOLC .


Mean values for postintervention patient QOC and QEOLC were @ ( @ % CI , @ to @ ) and @ ( @ % CI , @ to @ ) respectively , compared with @ ( @ % CI , @ to @ ) and @ ( @ % CI , @ to @ ) for control conditions .


After adjustment , comparing intervention with control , there was no significant difference in the QOC score for patients ( difference , @ points -LSB- @ % CI , -@ to @ -RSB- ; P = @ ) or families ( difference , @ -LSB- @ % CI , -@ to @ -RSB- ; P = @ ) .


There was no significant difference in QEOLC score for patients ( difference , @ points -LSB- @ % CI , -@ to @ -RSB- ; P = @ ) or families ( difference , @ -LSB- @ % CI , -@ to @ -RSB- ; P = @ ) .


The intervention was associated with significantly increased depression scores among patients of postintervention trainees ( mean score , @ -LSB- @ % CI , @ to @ -RSB- , compared with @ -LSB- @ % CI , @ to @ -RSB- ) for control conditions ; adjusted model showed an intervention effect of @ ( @ % CI , @ to @ ; P = @ ) .


Among internal medicine and nurse practitioner trainees , simulation-based communication training compared with usual education did not improve quality of communication about end-of-life care or quality of end-of-life care but was associated with a small increase in patients ' depressive symptoms .


These findings raise questions about skills transfer from simulation training to actual patient care and the adequacy of communication skills assessment .


NSAIDs , such as diclofenac , are the most commonly used medications to treat osteoarthritis ( OA ) , but they are associated with dose-related adverse events ( AEs ) .


Low-dose submicron diclofenac was developed using a new , proprietary dry milling process that creates submicron drug particles ( SoluMatrix Fine Particle Technology * ) , enabling effective treatment at lower doses than other commercially available diclofenac drug products .


This phase @ study evaluated the efficacy and safety of low-dose submicron diclofenac @mg three times daily ( tid ) and twice daily ( bid ) in patients with OA pain .


This double-blind study enrolled patients @ years of age with clinically and radiographically confirmed ( Kellgren-Lawrence grade II-III ) hip or knee OA .


Eligible patients were chronic NSAID and/or acetaminophen ( APAP ) users with baseline Western Ontario and McMasters Universities Osteoarthritis Index ( WOMAC ) pain subscale scores @mm by visual analog scale and an OA flare ( @mm increase in WOMAC pain subscale score following discontinuation of NSAIDs/APAP at screening ) .


Patients were randomized to submicron diclofenac @mg tid , submicron diclofenac @mg bid , or placebo for @ weeks .


ClinicalTrials.gov identifier : NCT@ .


Efficacy parameters included mean change from baseline in WOMAC pain subscale score at week @ ( primary efficacy parameter ) and in average total WOMAC score over @ weeks .


Submicron diclofenac @mg tid significantly improved WOMAC pain subscale scores from baseline at @ weeks ( -@ ; p = @ ) compared with placebo ( -@ ) .


Submicron diclofenac @mg bid provided numerical improvement in pain at week @ that did not reach statistical significance ( -@ ; p = @ ) compared with placebo .


Submicron diclofenac @mg tid ( -@ ; p = @ ) and @mg bid ( -@ ; p = @ ) improved the average total WOMAC score in treated patients over @ weeks compared with placebo ( -@ ) .


The most frequent AEs in the submicron diclofenac-treated groups were diarrhea , headache , nausea , and constipation .


The inclusion of patients with a documented requirement for analgesic therapy ( OA ` flare ' ) at baseline and the high rates of rescue medication usage in the placebo group may have impacted the study outcome for the submicron diclofenac treatment groups .


Low-dose submicron diclofenac is an effective therapeutic option for the treatment of OA pain .


The phase @ TRANSFORMS and FREEDOMS studies established the efficacy of fingolimod in reducing multiple sclerosis ( MS ) relapses and magnetic resonance imaging lesions compared with intramuscular ( IM ) interferon ( IFN ) -@ a and placebo over @ and @ months , respectively .


To investigate the efficacy of fingolimod at the approved @ mg dose in patients early in the MS disease course , post hoc subgroup analyses of TRANSFORMS ( n = @ ) and FREEDOMS ( n = @ ) data were conducted in patients who experienced their first MS symptom < @ years before randomization .


Fingolimod @ mg reduced annualized relapse rate by @ % ( P = @ ) versus IFN-@a IM and by @ % ( P < @ ) versus placebo in patients with < @ years since first symptom ; respective reductions were @ % and @ % in subgroups of patients with @ years since first symptom .


For patients with < @ years since their first symptom , significantly fewer new/newly enlarged T@ lesions were observed with fingolimod versus IFN-@a IM ( mean number , @ vs. @ ; P = @ ) or placebo ( @ vs. @ ; P < @ ) ; the mean number of gadolinium-enhancing T@ lesions was significantly reduced versus placebo ( @ vs. @ ; P < @ ) .


Fingolimod @ mg is highly effective in reducing relapses and MRI activity in patients early in the MS disease course .


Scarring from bacterial keratitis remains a leading cause of visual loss .


To determine whether topical corticosteroids are beneficial as an adjunctive therapy for bacterial keratitis if given early in the course of infection .


The Steroids for Corneal Ulcers Trial ( SCUT ) was a randomized , double-masked , placebo-controlled trial that overall found no effect of adding topical corticosteroids to topical moxifloxacin hydrochloride in bacterial keratitis .


Here , we assess the timing of administration of corticosteroids in a subgroup analysis of the SCUT .


We define earlier administration of corticosteroids ( vs placebo ) as addition after @ to @ days of topical antibiotics and later as addition after @ or more days of topical antibiotics .


We assess the effect of topical corticosteroids ( vs placebo ) on @-month best spectacle-corrected visual acuity in patients who received corticosteroids or placebo earlier vs later .


Further analyses were performed for subgroups of patients with non-Nocardia keratitis and those with no topical antibiotic use before enrollment .


Patients treated with topical corticosteroids as adjunctive therapy within @ to @ days of antibiotic therapy had approximately @-line better visual acuity at @ months than did those given placebo ( -@ logMAR ; @ % CI , -@ to -@ logMAR ; P = @ ) .


In patients who had @ or more days of antibiotic therapy before corticosteroid treatment , the effect was not significant ; patients given corticosteroids had @-line worse visual acuity at @ months compared with those in the placebo group ( @ logMAR ; @ % CI , -@ to @ logMAR ; P = @ ) .


Patients with non-Nocardia keratitis and those having no topical antibiotic use before the SCUT enrollment showed significant improvement in best spectacle-corrected visual acuity at @ months if corticosteroids were administered earlier rather than later .


There may be a benefit with adjunctive topical corticosteroids if application occurs earlier in the course of bacterial corneal ulcers .


We used data from a randomized trial of HIV-tuberculosis co-infected patients in Mozambique to determine the incidence and predictors of paradoxical tuberculosis-associated immune reconstitution inflammatory syndrome ( IRIS ) occurring within @ weeks of starting antiretroviral therapy , and to evaluate its association with patient outcome at @ weeks .


HIV-tuberculosis co-infected and antiretroviral therapy-nave adults with less than @ CD@/mm@ were randomized to a nevirapine or efavirenz-based antiretroviral therapy initiated @ to @ weeks after starting tuberculosis treatment , and were then followed for @ weeks .


Tuberculosis cases were diagnosed using WHO guidelines , and tuberculosis-IRIS by case definitions of the International Network for the Study of HIV-associated IRIS .


The @ HIV-tuberculosis co-infected patients who initiated antiretroviral therapy had a median CD@ count of @ cells/mm ( @ ) and HIV-@ RNA of @ log@ copies/mL .


Mortality at week @ was @ % ( @/@ ) .


Fifty-three ( @ % ) patients presented a tuberculosis-IRIS within @ weeks of starting antiretroviral therapy .


Being female and having a low CD@ count , high HIV-@ RNA load , low body mass index and smear-positive pulmonary tuberculosis were independently associated with tuberculosis-IRIS .


After adjustment for baseline body mass index , CD@ count and hemoglobin , occurrence of tuberculosis-IRIS was independently associated with @-week mortality ( aOR @ @ % CI @-@ @ ) .


Immunological and HIV-@ virological responses and tuberculosis treatment outcomes were not different between patients with and without tuberculosis-IRIS .


In this large prospective cohort , tuberculosis-IRIS occurrence within @ weeks of starting antiretroviral therapy was independently associated with the mortality of HIV-tuberculosis co-infected patients at @ weeks post antiretroviral therapy initiation .


Rifaximin , a nonabsorbable antibiotic that decreases lipopolysaccharide ( LPS ) in cirrhotics , may decrease the elevated levels of microbial translocation , T-cell activation and inflammation in human immunodeficiency virus ( HIV ) - positive immune nonresponders to antiretroviral therapy ( ART ) .


HIV-positive adults receiving ART for @ weeks with undetectable viremia for @ weeks and CD@ ( + ) T-cell counts < @ cells/mm ( @ ) were randomized @:@ to rifaximin versus no study treatment for @ weeks .


T-cell activation , LPS , and soluble CD@ were measured at baseline and at weeks @ , @ , and @ .


Wilcoxon rank sum tests compared changes between arms .


Compared with no study treatment ( n = @ ) , rifaximin ( n = @ ) use was associated with a significant difference between study arms in the change from baseline to week @ for CD@ ( + ) T-cell activation ( median change , @ % with rifaximin vs +@ % with no treatment ; P = @ ) .


This difference was driven by an increase in the no-study-treatment arm because there was no significant change within the rifaximin arm .


Similarly , although there were significant differences between study arms in change from baseline to week @ for LPS and soluble CD@ , there were no significant changes within the rifaximin arm .


In immune nonresponders to ART , rifaximin minimally affected microbial translocation and CD@ ( + ) T-cell activation .


Trial registration number.NCT@ .


Canagliflozin , a sodium glucose co-transporter @ inhibitor , lowers plasma glucose in individuals with hyperglycemia by inhibiting renal glucose reabsorption and increasing glucosuria .


Urinary tract infections ( UTIs ) were characterized in patients with type @ diabetes mellitus enrolled in Phase III studies of canagliflozin .


Analyses were performed in @ pooled datasets : Population @ ( N = @ ; mean exposure -LSB- weeks -RSB- : canagliflozin , @ ; placebo , @ ) including patients from @ placebo-controlled studies ; Population @ ( N = @ ; mean exposure -LSB- weeks -RSB- : canagliflozin , @ ; control , @ ) including patients from @ placebo - and active-controlled studies ( including patients with renal impairment or high risk of cardiovascular disease , and older patients ) .


Individual studies in special patient populations and @ active-controlled studies were analyzed separately .


Patients with a prior history of UTIs were not excluded from these studies .


Urinary tract infection frequency and characteristics were systematically collected , with additional information for each event collected using supplemental electronic case report forms .


In Populations @ and @ , canagliflozin @ and @ mg were associated with small increases in the incidence of UTIs compared with control , with no dose-dependence .


Urinary tract infections with canagliflozin were similar to those with control in severity , and upper UTIs were infrequent across groups .


No increase in serious events or those leading to discontinuation were seen with canagliflozin versus control .


Time to the first occurrence of symptomatic UTIs tended to be earlier with canagliflozin than placebo in Population @ , and similar with canagliflozin and control in Population @ ; median duration of events was similar across groups in both populations .


The proportion of patients with recurrent events was low across groups .


Canagliflozin was associated with a small increase in incidence of UTIs in patients with type @ diabetes mellitus , with no increase in serious or upper UTIs .


To compare the erosion protection efficacy of a stabilised , stannous fluoride ( SnF@ ) dentifrice versus a sodium fluoride ( NaF ) dentifrice using a modified in situ clinical model .


This study , a randomised parallel group in situ design with in vivo product use and ex vivo acid challenge , compared : A , a dentifrice containing @,@ ppm F as NaF ; B , a dentifrice containing @,@ ppm F ( @,@ ppm F as SnF@ + @ ppm F as NaF ) ; and T , tap water .


Sample size was n = @ per group ( total of @ subjects ) and within each subject appliances were placed on each side of the mouth ( left and right ) .


Enamel specimens were placed in different positions of the mouth ( front , mid-front , mid-rear , rear ) in each appliance ( total = @ specimens per subject ) .


Product treatment was twice per day ( lingual brushing for @ seconds followed by swishing for @ seconds with the resultant product/saliva slurry ) in vivo for @ days , and ex vivo acid treatment ( @ m citric acid @ minutes four times per day ; total exposure time = @ minutes ) .


Data were analysed using a general linear repeated measures model with treatment , side and position as fixed effects .


Within subjects , correlations were modelled assuming a different correlation and variance for treatment B relative to the other groups .


Pairwise treatment differences were performed using a @ % two-sided significance level .


Enamel loss ( in m ) was significantly lower ( P < @ ) for treatment B versus treatments A and T. Treatment B reduced enamel surface loss by @ % relative to treatment A.


There was no statistical difference in mean enamel loss ( P = @ ) between treatments A and T. Enamel loss was not statistically different for side ( left vs. right ; P = @ ) or position ( front , mid-front , mid-rear , rear ; P = @ ) .


This modified in situ erosion model confirmed the enhanced erosion protection benefits of a stabilised SnF@ dentifrice versus a conventional NaF dentifrice , validating the ability of the model to safely and effectively demonstrate differences in the erosion protection potential of oral care products .


Renin-angiotensin system ( RAS ) inhibition has proven to be helpful in reducing cardiovascular and kidney disease progression in the general population ; whether kidney transplant patients would derive similar benefits is unknown .


RAS inhibition also reduces posttransplantation erythrocytosis in kidney transplant recipients , but its effect on hemoglobin ( Hb ) levels in patients without posttransplantation erythrocytosis is unclear .


The Specific Management of Anemia and Hypertension in Renal Transplant ( SMAhRT ) recipients study was designed to examine the cardiovascular benefits of RAS blockade with telmisartan @ mg versus placebo , and Hb management with darbepoetin in a randomized , double-blind , single-center controlled trial in @,@ patients over @ years .


The primary efficacy variable was a composite of all-cause mortality , myocardial infarction or stroke .


The SMAhRT study was stopped prematurely due to a lower than expected event rate .


At that point , @ patients were enrolled and were followed for a mean duration of @ months .


The use of RAS blockade was not associated with an increased risk of adverse events such as worsening anemia or hyperkalemia .


Likewise , the correction of Hb with darbepoetin was not associated with any increase in thrombotic events .


This study provides insight into the safety of RAS inhibition and Hb correction with an erythrocyte-stimulating agent in kidney transplant recipients .


Although many initiatives exist to improve the availability of healthy foods in corner stores , few randomized trials have assessed their effects .


This study evaluated , in a randomized controlled trial , the effects of a first-generation healthy corner store intervention on students ' food and beverage purchases over a @-year period .


Participants ( n = @ ) were fourth - , fifth - , and sixth-grade students .


Ten schools and their nearby corner stores ( n = @ ) were randomly assigned to the healthy corner store intervention or an assessment-only control .


Intercept surveys directly assessed the nutritional characteristics of students ' corner store purchases at baseline , @ and @ years .


Students ' weight and heights were measured at baseline , @ and @ years .


There were no differences in energy content per intercept purchased from control or intervention schools at year @ ( P = @ ) or @ ( P = @ ) .


There were no differences between control and intervention students in BMI z score ( year @ , P = @ ; year @ , P = @ ) or obesity prevalence ( year @ , P = @ ; year @ , P = @ ) .


A healthy corner store initiative did not result in significant changes in the energy content of corner store purchases or in continuous or categorical measures of obesity .


These data will help to inform future interventions .


We investigated the effects of dietary intervention with canola or olive oil in comparison with commonly used refined oil in Asian Indians with nonalcoholic fatty liver disease ( NAFLD ) .


This was a @-month intervention study including @ males with NAFLD , matched for age and body mass index ( BMI ) .


Subjects were randomized into three groups to receive olive oil ( n = @ ) , canola oil ( n = @ ) , and commonly used soyabean/safflower oil ( control ; n = @ ) as cooking medium ( not exceeding @ g/day ) along with counseling for therapeutic lifestyle changes .


The BMI , fasting blood glucose ( FBG ) and insulin levels , lipids , homeostasis model of assessment for insulin resistance ( HOMA-IR ) , HOMA denoting - cell function ( HOMA-CF ) , and disposition index ( DI ) were measured at pre - and post-intervention .


Data were analyzed with one-way analysis of variance ( ANOVA ) and Tukey 's Honestly Significant Difference multiple comparison test procedures .


Olive oil intervention led to a significant decrease in weight and BMI ( ANOVA , P = @ ) compared with the control oil group .


In a comparison of olive and canola oil , a significant decrease in fasting insulin level , HOMA-IR , HOMA-CF , and DI ( P < @ ) was observed in the olive oil group .


Pre - and post-intervention analysis revealed a significant increase in high-density lipoprotein level ( P = @ ) in the olive oil group and a significant decrease in FBG ( P = @ ) and triglyceride ( P = @ ) levels in the canola oil group .


The pre - and post-intervention difference in liver span was significant only in the olive ( @ @ cm ; P < @ ) and canola ( @ @ cm ; P < @ ) oil groups .


In the olive and canola oil groups , post-intervention grading of fatty liver was reduced significantly ( grade I , from @ % to @ % and from @ % to @ % , respectively -LSB- P < @ -RSB- ; grade II , from @ % to @ % and from @ % to @ % , respectively -LSB- P < @ -RSB- ; and grade III , from @ % to none and from @ % to none , respectively ) .


In contrast , in the control oil group no significant change was observed .


Results suggest significant improvements in grading of fatty liver , liver span , measures of insulin resistance , and lipids with use of canola and olive oil compared with control oils in Asian Indians with NAFLD .


An association of clinical and subclinical hypothyroidism with mild cognitive impairment ( MCI ) has not been established .


To evaluate the association of clinical and subclinical hypothyroidism with MCI in a large population-based cohort .


A cross-sectional , population-based study was conducted in Olmsted County , Minnesota .


Randomly selected participants were aged @ to @ years on October @ , @ , and were without documented prevalent dementia -LSB- CORRECTED -RSB- .


A total of @ participants were evaluated and underwent in-person interview , neurologic evaluation , and neuropsychological testing to assess performance in memory , attention/executive function , and visuospatial and language domains .


Participants were categorized by consensus as being cognitively normal , having MCI , or having dementia according to published criteria .


Clinical and subclinical hypothyroidism were ascertained from a medical records linkage system .


Association of clinical and subclinical hypothyroidism with MCI .


Among @ eligible participants , the frequency of MCI was @ % in @ individuals with normal thyroid function , @ % in @ persons with clinical hypothyroidism , and @ % in @ individuals with subclinical hypothyroidism .


After adjusting for covariates ( age , educational level , sex , apolipoprotein E @ , depression , diabetes mellitus , hypertension , stroke , body mass index , and coronary artery disease ) we found no significant association between clinical or subclinical hypothyroidism and MCI ( odds ratio -LSB- OR -RSB- , @ -LSB- @ % CI , @-@ @ -RSB- and @ -LSB- @-@ @ -RSB- , respectively ) .


No effect of sex interaction was seen on these effects .


In stratified analysis , the odds of MCI with clinical and subclinical hypothyroidism among men was @ ( @ % CI , @-@ @ ) and @ ( @-@ @ ) and , among women , was @ ( @-@ @ ) and @ ( @-@ @ ) , respectively .


In this population-based cohort of elderly people , neither clinical nor subclinical hypothyroidism was associated with MCI .


Our findings need to be validated in a separate setting using the published criteria for MCI and confirmed in a longitudinal study .


To evaluate the clinical performance of adhesive restorations of resin composite and resin-modified glass-ionomer cements in primary molars .


This randomized clinical trial included subjects ( @-@ year-old children ) selected at two university centers ( UFRGS and UNIFRA ) .


The sample consisted of @ primary molars presenting active cavitated carious lesions ( with radiographic involvement of the inner half of the dentin ) , located on the occlusal and occlusal-proximal surface .


The sample was randomly divided into three groups , according to the restorative material : ( G@ ) universal restorative system ( Adper Single Bond @ system and Filtek Z@ ) ; ( G@ ) : Resin-modified glass-ionomer cement ( Vitremer ) ; and ( G@ ) : Low shrink restorative system ( Filtek P@ ) .


The restorations were clinically and radiographically followed every @ months for up to @ months using the USPHS modified criteria for clinical evaluation .


Survival estimates for restoration longevity were evaluated using the Kaplan-Meier method .


Log-rank test ( P < @ ) was used to compare the differences in the success rate according to the type of the restorative material .


The type of restorative material used did not influence the longevity of the restorations .


After clinical follow-up , there was no statistical difference in the rates of success for the three materials used to restore active cavitated carious lesions in primary molars .


The survival rates for the follow-up were similar regarding the number of restored surfaces and the caries removal technique ( partial or complete ) .


Mean estimated time of survival was @ months ( @ % CI : @-@ @ ) .


Estimated survival rates of the restorations were @ % , @ % , @ % and @ % at @ , @ , @ and @ months of clinical evaluations , respectively .


This study aimed to evaluate whether a high relative ADP induced aggregation ( r-ADP-agg ) is associated with an increased mortality in patients after coronary stent implantation .


Several trials were not able to improve clinical outcome by adapting platelet inhibition in patients after coronary stent implantation and high platelet reactivity ( HPR ) .


Platelet monitoring is complex and conventional definition of adenosindiphosphate ( ADP ) induced aggregation alone might not transfer the whole picture of adequate platelet inhibition in vivo .


In a prospective single-centre observational trial multiple electrode aggregometry was performed in whole blood of patients after stent implantation .


r-ADP-agg was defined as the ADP-thrombin receptor activating peptide ratio to reflect an individual degree of P@Y@ dependent platelet inhibition with a cut-off value for HPR of @ % .


The primary end point was mortality .


Follow-up was completed in @ of @ patients ( @ % ) with a mean follow-up time of @ years .


@ ( @ % ) patients revealed an r-ADP-agg @ % .


An r-ADP-agg @ % was associated with an increased mortality -LSB- unadjusted hazard ratio ( HR ) @ ( @-@ @ ) ; p = @ -RSB- .


In a multivariable Cox regression analysis mortality was independently associated with an r-ADP-agg @ % -LSB- HR @ ( @-@ @ ) ; p = @ -RSB- , ACS-setting -LSB- HR @ ( @-@ @ ) ; p = @ -RSB- and severely reduced LV function -LSB- HR @ ( @-@ @ ) ; p = @ -RSB- .


An r-ADP-agg @ % is associated with an increased mortality in patients after coronary stent implantation .


Furthermore , r-ADP-agg might represent a better tool to predict clinical outcome than the conventional ADP induced platelet aggregation alone .


The familial Mediterranean fever @ score ( FMF@ ) score was recently devised to define response to treatment and as an outcome measure for clinical trials of FMF .


To examine the performance of the FMF@ score in a previously published trial of rilonacept for patients whose FMF was resistant or intolerant to colchicine .


We re-analyzed the data from our controlled trial of rilonacept vs. placebo in @ patients with colchicine-resistant or intolerant FMF using the FMF@ score as the primary outcome .


The FMF@ score required improvement by @ in five of six criteria ( attack frequency , attack duration , global patient assessment , global physician assessment , frequency of attacks with arthritis , and levels of acute-phase reactants ) without worsening of the sixth criterion .


In the original trial rilonacept was considered effective according to the primary outcome measure ( differences in the attack frequency ) with eight analyzable patients considered responders and four as non-responders .


According to the FMF@ score , only two participants would have been considered respondersto rilonacept , and one to placebo .


Only two participants had @ % differences between rilonacept and placebo in five criteria .


The major explanation for non-response to treatment was that with rilonacept the duration of attack decreased by @ % in only @ participants and @ participants had no attacks of arthritis either during screening ( before randomization ) or during treatment with rilonacept .


The proposed FMF@ score did not differentiate well between responders and non-responders compared to the a priori defined primary outcome measure in this successful controlled study .


To test the effectiveness of messages designed to reduce vaccine misperceptions and increase vaccination rates for measles-mumps-rubella ( MMR ) .


A Web-based nationally representative @-wave survey experiment was conducted with @ parents age @ years and older residing in the United States who have children in their household age @ years or younger ( conducted June-July @ ) .


Parents were randomly assigned to receive @ of @ interventions : ( @ ) information explaining the lack of evidence that MMR causes autism from the Centers for Disease Control and Prevention ; ( @ ) textual information about the dangers of the diseases prevented by MMR from the Vaccine Information Statement ; ( @ ) images of children who have diseases prevented by the MMR vaccine ; ( @ ) a dramatic narrative about an infant who almost died of measles from a Centers for Disease Control and Prevention fact sheet ; or to a control group .


None of the interventions increased parental intent to vaccinate a future child .


Refuting claims of an MMR/autism link successfully reduced misperceptions that vaccines cause autism but nonetheless decreased intent to vaccinate among parents who had the least favorable vaccine attitudes .


In addition , images of sick children increased expressed belief in a vaccine/autism link and a dramatic narrative about an infant in danger increased self-reported belief in serious vaccine side effects .


Current public health communications about vaccines may not be effective .


For some parents , they may actually increase misperceptions or reduce vaccination intention .


Attempts to increase concerns about communicable diseases or correct false claims about vaccines may be especially likely to be counterproductive .


More study of pro-vaccine messaging is needed .


In Asian countries , paclitaxel once per week is used as second-line treatment in advanced gastric cancer , including human epidermal growth factor receptor @ ( HER@ ) - positive tumors .


The role of anti-HER@ agents , including lapatinib , in this setting and population is unclear .


TyTAN was a two-part , parallel-group , phase III study in Asian patients .


An open-label , dose-optimization phase ( n = @ ) was followed by a randomized phase ( n = @ ) , in which patients who were HER@ positive by fluorescence in situ hybridization ( FISH ) received lapatinib @,@ mg once per day plus once-per-week paclitaxel @ mg/m ( @ ) or paclitaxel alone .


The primary end point was overall survival ( OS ) .


Secondary end points included progression-free survival ( PFS ) , time to progression ( TTP ) , overall response rate ( ORR ) , time to response , response duration , and safety .


Analyses were based on immunohistochemistry ( IHC ) and gastrectomy status , prior trastuzumab therapy , and regional subpopulations .


Median OS was @ months with lapatinib plus paclitaxel versus @ months with paclitaxel alone ( P = @ ) , with no significant difference in median PFS ( @ v @ months ) or TTP ( @ v @ months ) .


ORR was higher with lapatinib plus paclitaxel versus paclitaxel alone ( odds ratio , @ ; P < @ ) .


Better efficacy with lapatinib plus paclitaxel was demonstrated in IHC@ + compared with IHC@/@ + and @ + patients and in Chinese compared with Japanese patients .


A similar proportion of patients experienced adverse events with each treatment ( lapatinib plus paclitaxel , @ % v paclitaxel alone , @ % ) .


Lapatinib plus paclitaxel demonstrated activity in the second-line treatment of patients with HER@ FISH-positive IHC@ + advanced gastric cancer but did not significantly improve OS in the intent-to-treat population .


To evaluate the efficacy of a brief @-w group-administered treatment program of cognitive behavior therapy for insomnia ( CBT-I ) for older adults with sleep maintenance insomnia .


Randomized controlled trial of CBT-I compared to waitlist control with comparisons at pretreatment , posttreatment , and @-mo follow-up .


Flinders University Sleep and Circadian Rhythm Research Laboratory , Adelaide , South Australia .


One-hundred eighteen adults with sleep maintenance insomnia ( mean age = @ y , standard deviation = @ y , male = @ ) .


A @-w , group-based treatment program of CBT-I including bedtime restriction therapy , sleep education , and cognitive restructuring .


Seven-day sleep diaries , actigraphy , and several self-report measures to assess perceived insomnia severity , daytime functioning , and confidence in and beliefs about sleep .


The brief group-administered CBT-I program produced improvements in the timing and quality of sleep including later bedtimes , earlier out-of-bed times , reduced wake after sleep onset , and improved sleep efficiency .


Participants also reported a reduction of the Insomnia Severity Index , Flinders Fatigue Scale , Epworth Sleepiness Scale , Daytime Feeling and Functioning Scale , Sleep Anticipatory Anxiety Questionnaire , the Dysfunctional Beliefs and Attitudes Scale , and increased Sleep Self-Efficacy Scale .


The treatment program used in the current study has demonstrated potential for a brief , inexpensive , and effective treatment of sleep maintenance insomnia in the older adult population .


Eating carbohydrate foods with a high glycemic index ( GI ) has been postulated to result in fetoplacental overgrowth and higher infant body fat .


A diet with a low glycemic index ( LGI ) has been shown to reduce birth percentiles and the ponderal index ( PI ) .


We investigated whether offering LGI dietary advice at the first antenatal visit would result in a lower fetal birth weight , birth percentile , and PI than providing healthy eating ( HE ) advice .


This advice had to be presented within the resources of routine antenatal care .


The Pregnancy and Glycemic Index Outcomes study was a @-arm , parallel-design , randomized , controlled trial that compared the effects of LGI dietary advice with HE advice on pregnancy outcomes .


Eligible volunteers who attended for routine antenatal care at < @ wk of gestation were randomly assigned to either group .


A total of @ women were enrolled , and @ women had final data considered .


In the LGI group , the GI was reduced from a mean ( SEM ) of @ @ at enrollment to @ @ ( P < @ ) at the final assessment .


There were no significant differences in primary outcomes of fetal birth weight , birth percentile , or PI .


In a multivariate regression analysis , the glycemic load was the only significant dietary predictor ( P = @ ) of primary outcomes but explained < @ % of all variation .


A low-intensity dietary intervention with an LGI diet compared with an HE diet in pregnancy did not result in any significant differences in birth weight , fetal percentile , or PI .


A large body of epidemiological and experimental evidence suggests that vitamin D deficiency may promote hypertension .


This raises the possibility that vitamin D supplementation could be a simple intervention to reduce blood pressure , but data from prospective , randomized trials are limited .


A double-blind , randomized , controlled trial was conducted at @ sites in the United States .


We enrolled @ individuals @ to @ years of age with low vitamin D status ( @-hydroxyvitamin D levels @ ng/mL ) and systolic blood pressure of @ to @ mm Hg .


Participants were randomized to high-dose ( @ IU/d ) versus low-dose ( @ IU/d ) oral vitamin D@ for @ months .


The primary end point was change in mean @-hour systolic blood pressure .


Secondary end points included change in ambulatory diastolic blood pressure and clinic systolic and diastolic blood pressures .


The median age was @ years , and @ % of participants were men .


Forty-six percent of participants were white , and @ % were black .


The median @-hydroxyvitamin D level at baseline was @ ng/mL .


Four-hundred fifty-five participants ( @ % ) had at least @ follow-up blood pressure measurement ; @ participants ( @ % ) completed the full @-month study .


At the end of the study , there was no significant difference in the primary end point ( change in mean @-hour systolic blood pressure , -@ versus -@ mm Hg in the high-dose and low-dose arms ; P = @ ) or in any of the secondary end points .


Furthermore , there was no evidence of association between change in @-hydroxyvitamin D and change in @-hour systolic blood pressure at @ months ( Spearman correlation coefficient , -@ , P = @ ) .


Results were consistent across prespecified subgroups .


Vitamin D supplementation did not reduce blood pressure in individuals with prehypertension or stage I hypertension and vitamin D deficiency .


Our findings suggest that the association between vitamin D status and elevated blood pressure noted in observational studies is not causal .


Threshold levels for peanut allergy determined by using oral challenges are important for the food industry with regard to allergen labeling .


Moreover , the utility of biological markers in predicting threshold levels is uncertain .


We sought to use a modified oral food challenge regimen that might determine threshold levels for peanut allergy mimicking a more real-life exposure and to correlate the eliciting dose ( ED ) and severity of clinical reaction in children with peanut allergy with B-cell , T-cell , and effector cell markers .


A modified food challenge procedure with doses scheduled @ hours apart was used in @ children with peanut allergy .


All children received a maximum of @ semi-log increasing titration steps of roasted peanuts ranging from @ to @ mg of peanut protein until objective allergic reactions occurred .


Severity of symptoms was graded from I to V. Biological markers were measured before challenge .


Forty-five of @ patients showed objective symptoms after greater than @ minutes , with a median latency of clinical reaction of @ minutes .


By using a log-normal dose-distribution model , the ED@ was calculated to be @ mg of peanut protein .


The ED was significantly and inversely correlated with peanut - and Ara h @-specific IgE levels , skin prick test responses , basophil activation , and TH@ cytokine production by PBMCs .


Symptom severity did not correlate with any of the markers or the ED .


This modified food challenge procedure might better reflect threshold levels for peanut allergy than the standard procedure because most of the patients reacted at a time interval of greater than @ minutes .


By using this model , threshold levels , but not severity , could be correlated with biological markers .


Bleeding esophageal varices has been studied extensively , but bleeding gastric varices ( BGV ) has received much less investigation .


However , BGV has been reported in @ % of patients with acute variceal bleeding .


In our studies of @,@ bleeding cirrhotics , @ % were bleeding from gastric varices .


BGV mortality rate of @-@ % has been reported .


The BGV literature has mainly involved retrospective case reports , often with short-term follow-up .


We sought to describe the results of a prospective , randomized , controlled trial ( RCT ) in unselected , consecutive patients with BGV comparing endoscopic therapy ( ET ) with portacaval shunt ( PCS ; n = @ ) , and later comparing emergency transjugular intrahepatic portosystemic shunt ( TIPS ) with emergency portacaval shunt ( EPCS ; n = @ ) .


Initially , our RCT involved @ patients with BGV comparing ET with direct PCS regarding control of bleeding , mortality rate , and disability .


When entry of patients ended , the RCT was expanded to compare emergency TIPS with EPCS ( n = @ ) .


This RCT of BGV was separate from our other RCTs of bleeding esophageal varices .


Initially , ET was compared with PCS .


In the second part of our RCT , emergency TIPS was compared with emergency PCS ( EPCS ) .


Outcomes were survival , control of bleeding , portal-systemic encephalopathy ( PSE ) , quality of life , and direct costs of care .


In the RCT of ET versus PCS , @ and @ % , respectively , were in Child class C.


In the expanded RCT of TIPS versus EPCS , @ and @ % , respectively , were in Child class C. Permanent control of BGV was achieved in @-@ % of patients treated by emergency or elective PCS , compared with @-@ % by ET .


TIPS was even less effective , achieving long-term control of BGV in only @ % .


Survival rates after PCS were greater at all time intervals and in all Child classes ( P < @ ) .


Repeated episodes of PSE occurred in @ % of TIPS patients , @-@ % treated by ET , and @-@ % treated by PCS .


Shunt stenosis or occlusion occurred in @ % of TIPS patients , in contrast with @-@ % of PCS patients .


These results support the conclusion that PCS is uniformly effective , whereas ET and TIPS are not very effective .


To measure the extent , determinants and results of bypassing local primary care clinics for childbirth among women in rural parts of the United Republic of Tanzania .


Women were selected in @ to complete a structured interview from a full census of all @ households in clinic catchment areas in Pwani region .


Eligibility was limited to those who had delivered between @ weeks and @ year before the interview , were at least @ years old and lived within the catchment areas .


Demographic and delivery care information and opinions on the quality of obstetric care were collected through interviews .


Clinic characteristics were collected from staff via questionnaires .


Determinants of bypassing ( i.e. delivery of the youngest child at a health centre or hospital without provider referral ) were analysed using multivariate logistic regression .


Bypasser and non-bypasser birth experiences were compared in bivariate analyses .


Of @ eligible women interviewed ( @ % response rate ) , @ % ( @ ) delivered in a health facility ; @ % ( @ ) were bypassers .


Bypassing likelihood increased with primiparity ( odds ratio , OR : @ ; @ % confidence interval , CI : @-@ @ ) and perceived poor quality at clinics ( OR : @ ; @ % CI : @-@ @ ) and decreased if clinics recently underwent renovations ( OR : @ ; @ % CI : @-@ @ ) and/or performed @ obstetric signal functions ( OR : @ ; @ % CI : @-@ @ ) .


Bypassers reported better quality of care on six of seven quality of care measures .


Many pregnant women , especially first-time mothers , choose to bypass local primary care clinics for childbirth .


Perceived poor quality of care at clinics was an important reason for bypassing .


Primary care is failing to meet the obstetric needs of many women in this rural , low-income setting .


Long-term effects of behavioural weight loss interventions on diabetes complications are unknown .


In a secondary analysis of the Look AHEAD ( Action for Health in Diabetes ) multicentre randomised clinical trial , we assessed whether an intensive lifestyle intervention ( ILI ) affects the development of nephropathy in people with type @ diabetes .


Overweight or obese people aged @-@ years with type @ diabetes were randomly assigned ( @:@ ) to ILI or to a diabetes support and education ( DSE ) group by a central web-based data management system , stratified by clinical centre and blocked with random block sizes .


The ILI was designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity .


The interventions were terminated early because of absence of effect on the primary outcome of cardiovascular disease events in the main Look AHEAD trial .


Albuminuria and estimated glomerular filtration rate were prespecified as two of many other outcomes and were assessed from baseline until the interventions ended .


They were combined post hoc to define the main outcome for this report , very-high-risk chronic kidney disease ( CKD ) , based on the @ Kidney Disease Improving Global Outcomes ( KDIGO ) classification .


Outcomes assessors and laboratory staff were masked to treatment , but participants and interventionists were not masked .


Time-to-event data were analysed by intention to treat by the Kaplan-Meier method and proportional hazards models .


The Look AHEAD trial is registered with ClinicalTrials.gov , NCT@ .


Of the @ participants randomly assigned in the Look AHEAD trial ( @ to ILI and @ to DSE ) , analyses for very-high-risk CKD were done in @ ( @ % ) of patients in the ILI group and @ ( @ % ) of those in the DSE group .


After a median of @ years ( IQR @-@ ) of follow-up , the incidence of very-high-risk CKD was lower in the ILI group than in the DSE group , with incidence rates of @ cases per @ person-years in the DSE group and @ per @ person-years in the ILI group ( difference @ cases per @ person-years , hazard ratio @ , @ % CI @-@ ; p = @ ) .


This effect was partly attributable to reductions in bodyweight , HbA@c , and systolic blood pressure .


There were no safety concerns regarding kidney-related adverse events .


Weight loss should be considered as an adjunct to medical treatments to prevent or delay progression of CKD in overweight or obese people with type @ diabetes .


To identify factors associated with variability in rifampin plasma pharmacokinetics and explore the relationship between rifampin pharmacokinetics and change in efavirenz plasma pharmacokinetics with rifampin coadministration .


In this randomized , cross-over study , @ healthy volunteers received either efavirenz @mg/day or efavirenz @mg with rifampin @mg/day for @days .


After a washout period of at least @weeks , subjects crossed over to the alternate @-day regimen .


Samples were obtained for pharmacokinetic assessment on day @ of each study cycle .


Drugs concentrations were determined by a validated high-performance liquid chromatography .


Pharmacokinetic parameters were calculated using noncompartmental analysis .


Multivariate analysis was used to examine factors associated with rifampin pharmacokinetics .


Spearman correlation analysis was used to investigate relationship between rifampin pharmacokinetics and change in efavirenz plasma pharmacokinetics with rifampin coadministration .


Of @ evaluable subjects , the median interquartile range , rifampin peak concentration ( Cmax ) , area under the concentration-time curve ( AUC@-@hour ) , and weight-normalized clearance were @ ( @-@ @ ) g/ml , @ ( @-@ @ ) gh/ml , and @ ( @-@ @ ) L/h/kg , respectively .


Solute carrier organic anion transporter family member @B@ ( SLCO@B@ ) c. @AG and SLCO@B@ c. @CA polymorphisms jointly had significant effect on rifampin Cmax ( R ( @ ) = @ ) .