We aimed to compare the clinical outcomes of intra-articular calcaneus fractures treated with open reduction and internal fixation with conventional plate via L-shaped lateral approach ( routine treatment ) versus those with percutaneous plate via a sinus tarsi approach ( minimally invasive treatment ) .


One hundred and seventeen displaced intra-articular calcaneal fractures in @ patients from January @ and September @ were randomly allocated to receive routine treatment ( @ patients ) or minimally invasive treatment ( @ patients ) .


Operative time , preoperative and postoperative calcaneal height , width , length , Bhlers angle , Gissanes angle , and incision healing were recorded .


Maryland foot score system was used to evaluate clinical functional outcomes .


The operative time of minimally invasive group was significantly shorter than that of the routine group -LSB- @-@ min ( mean , @ min ) vs @-@ min ( mean , @ min ) , p < @ -RSB- .


Postoperative X-ray showed the calcaneal height , width , length , Bhlers angle and Gissanes angle were significantly improved in both two groups , and no significant difference was observed between two groups postoperatively .


No feet developed wound complications in minimally invasive group , but incision complications occurred in @ feet in routine group .


The excellent and good rate according to the Maryland foot score was significantly higher in minimally invasive group than that in the routine group ( @ % vs @ % ) .


Compared with L-shaped lateral approach treatment of displaced intra-articular calcaneal fractures , sinus tarsi approach for the reduction and internal fixation with percutaneous plate seems to be more safe and effective , with satisfactory clinical therapeutic effects and without postoperative complications .


The incidence of acute kidney injury ( AKI ) is estimated at @ to @ % in patients admitted to intensive care units ( ICU ) and often requires renal replacement therapy ( RRT ) .


ICU mortality in AKI patients can exceed @ % .


Venous catheters are the preferred vascular access method for AKI patients requiring RRT , but carry a risk of catheter thrombosis or infection .


Catheter lock solutions are commonly used to prevent such complications .


Heparin and citrate locks are both widely used for tunneled , long-term catheters , but few studies have compared citrate versus heparin for patients with short-term , non-tunneled catheters .


We aim to compare citrate @ % catheter lock solution versus heparin in terms of event-free survival of the first non-tunneled hemodialysis catheter inserted in ICU patients with AKI requiring RRT .


Secondary objectives are the rate of fibrinolysis , incidence of catheter thrombosis and catheter-related infection per @,@ catheter days , length of stay in ICU and in-hospital and @-day mortality .


The VERROU-REA study is a randomized , prospective , multicenter , double-blind , parallel-group , controlled superiority study carried out in the medical , surgical and nephrological ICUs of two large university hospitals in eastern France .


A catheter lock solution composed of trisodium citrate at @ % will be compared to unfractionated heparin at a concentration of @,@ IU/mL .


All consecutive adult patients with AKI requiring extracorporeal RRT , and in whom a first non-tunneled catheter is to be inserted by the jugular or femoral approach , will be eligible .


Catheters inserted by the subclavian approach , patients with acute liver failure , thrombopenia or contraindication to systemic anticoagulation will be excluded .


Patients will be followed up daily in accordance with standard practices for RRT until death or discharge .


Data is scarce regarding the use of non-tunneled catheters in the ICU setting in patients with AKI .


This study will provide an evidence base for recommendations regarding the use of anticoagulant catheter locks for the prevention of dysfunction in non-tunneled hemodialysis catheters in patients with AKI in critical or intensive care .


This is a controlled , prospective study which compares the effects of a low-dose heat patch for self-medication on the reduction of pain symptoms in dysmenorrhea .


The sample group included female sophomore students studying at a university in Istanbul , Turkey , between @ and @ .


These female participants completed the Dysmenorrhea Identification Form to determine the sample group , and a total of @ female students possessed the eligible criteria .


The research control group consisted of @ patients , the analgesia group consisted of @ , and the heat patch group consisted of @ .


The control group did not use any treatments , while the self-medication group used analgesic medication ( single dose ) , and the heat patch group applied a heat patch on the lower abdomen , against the skin , for an application period of @ menstrual cycles .


Using a visual analog scale ( VAS ) , the pain severity was recorded at the baseline , after @ hours of intervention , and after @ hours of intervention .


The data were examined using ANOVA .


There were significant differences between the groups in terms of pain severity after @ hours of application ( P < @ ) .


All groups had similar pain levels at baseline and during the fourth and eighth hours , with no significant differences between the groups during the first and the second menstrual cycles ( P > @ ) .


The authors conclude that the heat patch is an effective method for reducing dysmenorrhea .


Paradoxically , a breast cancer risk reduction with conjugated equine estrogens ( CEE ) and a risk elevation with CEE plus medroxyprogesterone acetate ( CEE+MPA ) were observed in the Women 's Health Initiative ( WHI ) randomized controlled trials .


The effects of hormone therapy on serum sex hormone levels , and on the association between baseline sex hormones and disease risk , may help explain these divergent breast cancer findings .


Serum sex hormone concentrations were measured for @ breast cancer cases in the CEE+MPA trial and for @ cases in the CEE trial along with corresponding pair-matched controls , nested within the WHI trials of healthy postmenopausal women .


Association and mediation analyses , to examine the extent to which sex hormone levels and changes can explain the breast cancer findings , were conducted using logistic regression .


Following CEE treatment , breast cancer risk was associated with higher concentrations of baseline serum estrogens , and with lower concentrations of sex hormone binding globulin .


However , following CEE+MPA , there was no association of breast cancer risk with baseline sex hormone levels .


The sex hormone changes from baseline to year @ provided an explanation for much of the reduced breast cancer risk with CEE .


Specifically , the treatment odds ratio ( @ % confidence interval ) increased from @ ( @ , @ ) to @ ( @ , @ ) when the year @ measures were included in the logistic regression analysis .


In comparison , the CEE+MPA odds ratio was essentially unchanged when these year @ measures were included .


Breast cancer risk remains low following CEE use among women having favorable baseline sex hormone profiles , but CEE+MPA evidently produces a breast cancer risk for all women similar to that for women having an unfavorable baseline sex hormone profile .


These patterns could reflect breast ductal epithelial cell stimulation by CEE+MPA that is substantially avoided with CEE , in conjunction with relatively more favorable effects of either regimen following a sustained period of estrogen deprivation .


These findings may have implications for other hormone therapy formulations and routes of delivery .


Cerebral autosomal-dominant arteriopathy with subcortical infarcts and leukoencephalopathy ( CADASIL ) , a rare autosomal dominant disorder caused by NOTCH@ mutations , is characterized by vascular smooth muscle and endothelial cells abnormalities , altered vasoreactivity , and recurrent lacunar infarcts .


Vasomotor function may represent a key factor for disease progression .


Tetrahydrobiopterin , essential cofactor for nitric oxide synthesis in endothelial cells , ameliorates endothelial function .


We assessed whether supplementation with sapropterin , a synthetic tetrahydrobiopterin analog , improves endothelium-dependent vasodilation in CADASIL patients .


In a @-month , multicenter randomized , double-blind , placebo-controlled trial , CADASIL patients aged @ to @ years were randomly assigned to receive placebo or sapropterin @ to @ mg BID .


The primary end point was change in the reactive hyperemia index by peripheral arterial tonometry at @ months .


We also assessed the safety and tolerability of sapropterin .


Analysis was done by intention-to-treat .


The intention-to-treat population included @ patients .


We found no significant difference between sapropterin ( n = @ ) and placebo ( n = @ ) in the primary end point ( mean difference in reactive hyperemia index by peripheral arterial tonometry changes @ -LSB- @ % confidence interval , -@ , @ -RSB- ) .


Reactive hyperemia index by peripheral arterial tonometry increased after @ months in @ % of patients on sapropterin and in @ % on placebo ; however , after adjustment for age , sex , and clinical characteristics , improvement was not associated with treatment arm .


The proportion of patients with adverse events was similar on sapropterin and on placebo ( @ % versus @ % ) ; serious adverse events occurred in @ % versus @ % , respectively .


Sapropterin was safe and well-tolerated at the average dose of @ mg/kg/day , but did not affect endothelium-dependent vasodilation in CADASIL patients .


Community-based efforts to prevent adolescent problem behaviors are essential to promote public health and achieve collective impact community wide .


OBJECTIVE To test whether the Communities That Care ( CTC ) prevention system reduced levels of risk and adolescent problem behaviors community wide @ years after implementation of CTC .


A community-randomized trial was performed in @ small towns in @ states , matched within state , assigned randomly to a control or intervention group in @ .


All fifth-grade students attending public schools in study communities in @-@ who received consent from their parents to participate ( @ % of the eligible population ) were included .


A panel of @ fifth graders was surveyed through @th grade , with @ % of the sample participating at the last follow-up .


A coalition of community stakeholders received training and technical assistance to install CTC , used epidemiologic data to identify elevated risk factors and depressed protective factors for adolescent problem behaviors in the community , and implemented tested and effective programs for youths aged @ to @ years as well as their families and schools to address their community 's elevated risks .


MAIN OUTCOMES AND MEASURES Levels of targeted risk ; sustained abstinence , and cumulative incidence by grade @ ; and current prevalence of tobacco , alcohol , and other drug use , delinquency , and violence in @th grade .


By spring of @th grade , students in CTC communities were more likely than students in control communities to have abstained from any drug use ( adjusted risk ratio -LSB- ARR -RSB- = @ ; @ % CI , @-@ @ ) , drinking alcohol ( ARR = @ ; @ % CI , @-@ @ ) , smoking cigarettes ( ARR = @ ; @ % CI , @-@ @ ) , and engaging in delinquency ( ARR = @ ; @ % CI , @-@ @ ) .


They were also less likely to ever have committed a violent act ( ARR = @ ; @ % CI , @-@ @ ) .


There were no significant differences by intervention group in targeted risks , the prevalence of past-month or past-year substance use , or past-year delinquency or violence .


Using the CTC system continued to prevent the initiation of adolescent problem behaviors through @th grade , @ years after implementation of CTC and @ years after study-provided resources ended , but did not produce reductions in current levels of risk or current prevalence of problem behavior in @th grade .


TRIAL REGISTRATION clinicaltrials.gov Identifier : NCT@ .


In some randomized controlled trials laparoscopic cholecystectomy ( LC ) for acute cholecystitis was associated with a shorter hospital stay when compared with open cholecystectomy ( OC ) .


These studies were not double blinded and without intention to treat purpose .


The present study project was a prospective , randomized investigation .


The study was performed in the Department of General , Emergency and Transplant Surgery St Orsola-Malpighi University Hospital ( Bologna , Italy ) .


Subjects were divided in two groups : in the first group the patient was submitted to LC while in the second group was submitted to OC .


Of @ consecutive patients , @ were excluded from the study .


The two groups were similar in demographic and clinical characteristics .


Seven ( @ % ) patients in the LC group required conversion to OC .


There were no deaths or bile duct lesions in either group , and the postoperative complication rate was similar ( p = n.s. ) .


The mean postoperative hospital stay was also comparable .


Even though LC for acute and gangrenous cholecystitis is technically demanding , in experienced hands it is safe and effective .


It does not increase the mortality and the morbidity rate with a low conversion rate and no difference in hospital stay .


The role of three factors in drinking outcome after brief intervention among heavily drinking HIV patients were investigated : strength of commitment to change drinking , alcohol dependence , and treatment type : brief Motivational Interview ( MI ) only , or MI plus HealthCall , a technological extension of brief intervention .


HIV primary care patients ( N = @ ) who drank @ drinks at least once in the @ days before study entry participated in MI-only or MI+H ealthCall in a randomized trial to reduce drinking .


Patients were @ % minority ; @ % female ; @ % alcohol dependent ; mean age @ .


Outcome at end of treatment ( @ days ) was drinks per drinking day ( Timeline Follow-Back ) .


Commitment strength ( CS ) was rated from MI session recordings .


Overall , stronger CS predicted end-of-treatment drinking ( p < @ ) .


After finding an interaction of treatment , CS and alcohol dependence ( p = @ ) , we examined treatmentCS interactions in alcohol dependent and non-dependent patients .


In alcohol dependent patients , the treatmentcommitment strength interaction was significant ( p = @ ) ; patients with low commitment strength had better outcomes in MI+H ealthCall than in MI-only ( lower mean drinks per drinking day ; @ and @ drinks , respectively ) .


In non-dependent patients , neither treatment nor CS predicted outcome .


Among alcohol dependent HIV patients , HealthCall was most beneficial in drinking reduction when MI ended with low commitment strength .


HealthCall may not merely extend MI effects , but add effects of its own that compensate for low commitment strength .


Thus , HealthCall may also be effective when paired with briefer interventions requiring less skill , training and supervision than MI .


Replication is warranted .


To evaluate the effectiveness of the Healthy School and Drugs programme on alcohol , tobacco and marijuana use among Dutch early adolescents .


Randomized clustered trial with two intervention conditions ( i.e. e-learning and integral ) .


General population of @-@-year-old adolescents in the Netherlands .


A total of @ students of @ Dutch secondary schools .


Structured digital questionnaires were administered pre-intervention and at @ months follow-up .


The primary outcome measures were new incidences of alcohol ( life-time and @-month prevalence ) , tobacco ( life-time and @-month prevalence ) and marijuana use ( life-time prevalence ) .


Main effect analyses showed no programme effects on incidences of alcohol consumption ( life-time prevalence : e-learning condition : B = @ , P = @ ; integral condition : B = -@ , P = @ ; @-month prevalence : e-learning condition : B = @ , P = @ ; integral condition : B = -@ , P = @ ) , tobacco consumption ( life-time prevalence : e-learning condition : B = @ , P = @ ; integral condition : B = @ , P = @ ; @-month prevalence : e-learning condition : B = @ , P = @ ; integral condition : B = @ , P = @ ) , or marijuana consumption ( life-time prevalence : e-learning condition : B = @ , P = @ ; integral condition : B = @ , P = @ ) .


The non-significant impact of the Healthy School and Drugs programme ( a Dutch school-based prevention programme for early adolescents ) on incidences of alcohol , tobacco and marijuana use indicates that the programme is either ineffective or implemented inadequately .


Esophageal resection is associated with a high incidence of postoperative pneumonia .


Respiratory complications account for almost half of the readmissions to the critical care unit .


Postoperative complications can result in prolonged hospital stay and consequently increase healthcare costs .


In cardiac surgery a preoperative inspiratory muscle training program has shown to prevent postoperative pneumonia and reduce length of hospital stay .


While in some surgical centers inspiratory muscle training is already used in the preoperative phase in patients undergoing esophageal resection , the added value of this intervention on the reduction of pulmonary complications has not yet been investigated in large surgical populations other than cardiac surgery in a randomized and controlled study design .


The effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection will be studied in a single blind multicenter randomized controlled trial ( the PREPARE study ) .


In total @ patients ( age > @years ) undergoing esophageal resection for esophageal cancer will be included in this study .


They are randomized to either usual care or usual care with an additional inspiratory muscle training intervention according to a high-intensity protocol which is performed with a tapered flow resistive inspiratory loading device .


Patients have to complete @ dynamic inspiratory efforts twice daily for @days a week until surgery with a minimum of @weeks .


The starting training load will be aimed to be @ % of maximal inspiratory pressure and will be increased based on the rate of perceived exertion.The main study endpoint is the incidence of postoperative pneumonia .


Secondary objectives are to evaluate the effect of preoperative inspiratory muscle training on length of hospital stay , duration of mechanical ventilation , incidence of other postoperative ( pulmonary ) complications , quality of life , and on postoperative respiratory muscle function and lung function .


The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection .


Few data are available on the influence of a colonoscope length for trainees , which could affect both the duration of training and colonoscopy quality .


We conducted this study to validate which scope needs more duration for training to reach technical competence and to shows better quality indicators during diagnostic colonoscopy .


We conducted a prospective randomly assigned study from April @ to February @ at Asan Medical Center .


Among the @ patients enrolled , @ colonoscopies were analyzed .


We compared cecal intubation rate , adenoma detection rate , cecal intubation time ( < @ min ) , and withdrawal time between the trainees using the intermediate-length colonoscope and those using long-length colonoscope .


Trainees who used the long-length colonoscope showed a higher overall cecal intubation rate ( @ % vs. @ % , p = @ ) and adenoma detection rate ( @ % vs. @ % , p < @ ) than those using the intermediate-length colonoscope .


The successful cecal intubation rate improved significantly and reached the requisite standard of competence ( > @ % ) after @ procedures in the long-length colonoscope group .


However , the trainees using the intermediate-length colonoscope reached the requisite standard of competence after @ procedures .


Logistic regression analysis revealed that prolonged cecal intubation was associated with the use of the intermediate-length colonoscope , poor colon preparation , a small number of esophagastroduodenoscopy or sigmoidoscopy procedures conducted , and pain during procedures .


During the same training period , use of the long-length colonoscope in trainee was better in terms of reaching competency and quality indicators , and was less painful for the patients during colonoscopic procedures .


The current study was performed to investigate the effects of the Dietary Approaches to Stop Hypertension ( DASH ) eating plan on pregnancy outcomes in pregnant women with gestational diabetes mellitus ( GDM ) .


This randomized controlled clinical trial was performed among @ women diagnosed with GDM .


Participants were randomly assigned to consume either the control ( n = @ ) or the DASH diet ( n = @ ) for @ weeks .


The control diet was designed to contain @-@ % carbohydrates , @-@ % protein and @-@ % total fat .


The DASH diet was rich in fruits , vegetables , whole grains and low-fat dairy products , and contained lower amounts of saturated fats , cholesterol and refined grains with a total of @ mg/day sodium .


The numbers of women who commenced insulin therapy after dietary intervention , the mode of delivery and prevalence of polyhydramnios were assessed .


The length , weight and head circumference of infants were measured during the first @ h after birth .


Whereas @ % of women in the DASH diet needed to have a cesarean section , this percentage for the control group was @ % ( P = @ ) .


The percentage of those who needed to commence insulin therapy after intervention was also significantly different between the two groups ( @ % for DASH vs @ % for control group , P < @ ) .


Infants born to mothers on the DASH diet had significantly lower weight ( @ vs @ g , P < @ ) , head circumference ( @ vs @ cm , P = @ ) and ponderal index ( @ vs @ kg/m ( @ ) , P < @ ) compared with those born to mothers on the control diet .


In conclusion , consumption of DASH diet for @ weeks among pregnant women with GDM resulted in improved pregnancy outcomes .


Functional near-infrared spectroscopy ( fNIRS ) is an emerging technique for the in vivo assessment of functional activity of the cerebral cortex as well as in the field of brain-computer interface ( BCI ) research .


A common challenge for the utilization of fNIRS in these areas is a stable and reliable investigation of the spatio-temporal hemodynamic patterns .


However , the recorded patterns may be influenced and superimposed by signals generated from physiological processes , resulting in an inaccurate estimation of the cortical activity .


Up to now only a few studies have investigated these influences , and still less has been attempted to remove/reduce these influences .


The present study aims to gain insights into the reduction of physiological rhythms in hemodynamic signals ( oxygenated hemoglobin ( oxy-Hb ) , deoxygenated hemoglobin ( deoxy-Hb ) ) .


We introduce the use of three different signal processing approaches ( spatial filtering , a common average reference ( CAR ) method ; independent component analysis ( ICA ) ; and transfer function ( TF ) models ) to reduce the influence of respiratory and blood pressure ( BP ) rhythms on the hemodynamic responses .


All approaches produce large reductions in BP and respiration influences on the oxy-Hb signals and , therefore , improve the contrast-to-noise ratio ( CNR ) .


In contrast , for deoxy-Hb signals CAR and ICA did not improve the CNR .


However , for the TF approach , a CNR-improvement in deoxy-Hb can also be found .


The present study investigates the application of different signal processing approaches to reduce the influences of physiological rhythms on the hemodynamic responses .


In addition to the identification of the best signal processing method , we also show the importance of noise reduction in fNIRS data .


To study effect of combined therapy with amlodipine with ramipril on the circadian profile of arterial pressure in patients with arterial hypertension in the Far North depending on the shiftwork regime .


@ patients with grade @-@ AH were divided into @ groups depending on the work-time schedule .


Group @ included @ daywork patients group @ consisted of @ patients working in the alternating daywork and nightwork regime .


@ hr AH monitoring was performed before , @ weeks and @ months after the onset of the study .


Six months after the onset of therapy practically all patients reached the target AD level ( @ % in group @ and @ % in group ) .


The patients fairly well tolerated therapy AD circadian profile was normalized @ times in group @ and @ times in group @ .


Recovered AP variability in group @ resulted in a decreased frequency of target organ affection .


In group @ , the initially higher variability accounted for the normalization of only diastolic AP variability after @ month therapy .


It suggests the necessity of prescription of a third anti-AH preparation to these patients .


Morning AP dynamics improved in both groups .


To ( @ ) develop a model of cyclical adduction force on an abducted left arytenoid cartilage that mimics swallowing or coughing ; ( @ ) determine if arytenoid abduction by a clamp before knot tying will improve the maintenance of abduction under cyclical adduction testing .


Experimental .


Cadaveric equine larynges ( n = @ ) .


Left laryngoplasty performed using a single suture of # @ Ethibond with ( n = @ ) and without ( n = @ ) abducting the arytenoid with a clamp before knot tying .


Each laryngoplasty was loaded cyclically from @ to @N at @ Hz for @ cycles in a servohydraulic test frame .


Arytenoid displacement data were collected at @Hz intervals and median percent loss of abduction compared between groups .


Significance was set at P < @ .


Median left arytenoid abduction distance was @ mm ( range , @-@ @ mm ) .


One larynx in each group failed at < @ cycles .


Loss of abduction was determined by progressive displacement of the testing actuator and confirmed by measurement .


There was no difference in loss of abduction between clamped and non-clamped larynges after @ cycles .


This model of cyclical adduction resulted in arytenoid displacements similar to those seen in the @st week postoperatively .


Ex vivo cyclical adductory forces produced a significant loss of laryngoplasty abduction .


The use of a clamp to abduct the arytenoid cartilage before knot tying did not reduce the loss of abduction .


To assess the potential efficacy , safety , and optimal dosing concentration of tavaborole , a novel , boron-based pharmaceutical agent with broad-spectrum antifungal activity , for the treatment of onychomycosis of the toenail due to dermatophytes .


One double-blind , randomized , vehicle-controlled study ( study @ ) and two open-label studies ( studies @ and @ ) examined the efficacy , safety , and optimal dosing concentration of tavaborole topical solution applied once daily or three times weekly for @ days at concentrations of @ % , @ % , @ % , or @ % .


Patient cohort @ of study @ received open-label tavaborole @ % once daily for @ days .


All three studies assessed day @ treatment success , defined as complete or partial clinical evidence of clear nail growth plus negative fungal culture .


A total of @ patients were included in the intent-to-treat ( ITT ) or modified ITT populations and efficacy analyses across the @ studies .


In study @ , treatment success rates at day @ were higher with tavaborole @ % , @ % , and @ % vs vehicle ( @ % , @ % , and @ % vs @ % , respectively ; slope P = @ ) .


In cohort @ of study @ , @ % of patients achieved treatment success with tavaborole @ % at day @ .


Negative culture rates at day @ in study @ were numerically higher for tavaborole @ % , @ % , and @ % vs vehicle ( slope P = @ ) .


Application-site reactions of general irritation , erythema , scaling , and stinging/burning were most common with tavaborole @ % , were generally mild to moderate , and resolved with treatment discontinuation and/or a reduction in dosing frequency .


No systemic safety concerns were observed .


Tavaborole solution demonstrated favorable efficacy and safety in phase @ clinical studies .


Based on these findings , tavaborole topical solution , @ % was further investigated in larger , more definitive phase @ studies .


Results from these completed phase @ studies will provide additional evidence regarding the safety and efficacy of tavaborole in the treatment of toenail onychomycosis .


Evidence about long-term effects of preventive health services for youth with complex needs is lacking .


Prime Time , a youth development intervention , aims to reduce pregnancy risk among vulnerable adolescent females seeking clinic services .


In a randomized trial , @ sexually active females aged @-@ who were at high risk for pregnancy were assigned to the Prime Time intervention or usual clinic services .


The @-month intervention , initiated in @-@ , comprised regular meetings with case managers and participation in youth leadership groups .


Trial participants completed surveys at baseline and @ months .


Regression analyses were used to evaluate differences between groups in sexual and psychosocial outcomes at follow-up .


At @ months , the intervention group reported more months of consistent condom use ( adjusted means , @ vs. @ ) and dual contraceptive use ( @ vs. @ ) in the past seven months than did controls .


The intervention was most effective in promoting consistent use among participants with relatively high levels of connectedness to family or school .


Fifteen percent of intervention participants , but only @ % of controls , reported having abstained from sex in the past six months ( adjusted odds ratio , @ ) .


Moreover , among high school graduates , those in the intervention group were more likely than those in the control group to have enrolled in college or technical school ( @ % vs. @ % ; odds ratio , @ ) .


Health services grounded in a youth development framework can lead to reductions in sexual risk among vulnerable youth that are evident one year following conclusion of services .


We aimed to investigate the population pharmacokinetics ( PK ) of soluble recombinant human tumor necrosis factor receptor fusion protein ( rhTNFR - Fc ) in Chinese patients with rheumatic arthritis ( RA ) .


The PK differences between Chinese patients with RA and healthy Chinese subjects were also compared .


@ patients were randomized to a single subcutaneous ( SC ) injections of @ mg ( n = @ ) , @ mg ( n = @ ) , and @ mg ( n = @ ) of rhTNFR-Fc , and six SC injection of rhTNFR - Fc at @ mg once in @ days ( n = @ ) respectively .


A total of @ serum concentration data points were collected in the RA patients .


The population PK analysis was performed by NONMEM .


Based on the population PK parameters obtained herein and those reported in healthy Chinese subjects , simulation was conducted to compare the difference of rhTNFR-Fc exposure between these populations .


The PK data of Chinese patients with RA were best described by a one compartment model with lag time .


A higher CL/F was noted in RA patients compared with that of the healthy Chinese subjects ( @ L/h vs. @ L/h ) , and a lower Ka was noticed in the RA patients compared with that of the healthy subjects ( @ h-@ vs. @ h-@ ) .


The simulate results showed that rhTNFR-Fc exposure in Chinese patients with RA was significantly lower than that in healthy subjects .


The mean patients/healthy subjects C ( max ) and AUC ( ss ) ratios were @ and @ , respectively .


A population PK model of rhTNFR - Fc was developed in Chinese patients with RA .


Statistical difference was noted in the PK of rhTNFR-Fc between Chinese patients with RA and healthy Chinese subjects .


Korean red ginseng ( KRG ) is a processed ginseng from raw ginseng to enhance safety , preservation and efficacy , known having beneficial effects on women 's health due to its estrogen like function .


While estrogen supplementation showed some modulation of endocrine disrupting chemicals , bisphenol A ( BPA ) has been focused as a potential endocrine disrupting chemical .


In this study , we examined the efficacy and safety outcomes of KRG against BPA , focusing on female quality of life ( QOL ) .


Individual variations in susceptibility to KRG were also investigated with the Sasang Typology , the personalized medicine used for hundred years in Korea .


We performed a single-blind randomized clinical trial .


Study subjects were young women ( N = @ ) , consumed @ g of KRG or placebo per day for @ weeks and filled up questionnaires regarding gynecologic complaints at the @ time spots .


We analyzed urinary total BPA and malondialdehyde ( MDA ) , an oxidative stress biomarker , with GC/MS and HPLC/UVD respectively , and diagnosed their Sasang Typology with the questionnaire for the Sasang constitution Classification ( QSCC II ) .


KRG consumption decreased urinary BPA and MDA levels ( ps < @ ) and alleviated ` menstrual irregularity ' , ` menstrual pain ' , and ` constipation ' ( ps < @ ) .


SoEum type ( Lesser Yin person ) among the Sasang types showed significant alleviation in insomnia , flushing , perspiration and appetite by KRG consumption , rather than other Sasang types .


During the intervention , no one experienced any aggravated side effects .


We suggest KRG is efficient for protection for female QOL and BPA - exposure and - related oxidative stress .


However , individual variation in susceptibility to KRG should be further considered for identifying ideal therapy .


Conventional total uncinectomy may be unnecessary in localized maxillary sinus lesion .


Partial removal of the uncinate process and middle meatal antrostomy would be sufficient to eradicate the pathological condition .


Therefore , we aimed to evaluate the efficacy of partial uncinectomy versus total removal of the uncinate process in patients with localized maxillary sinus disease .


In total , @ patients were assigned randomly to partial and total uncinectomy groups .


Preoperative computed tomography established that all patients had localized pathology in the maxillary sinus .


The lower half of the uncinate process was removed in the partial uncinectomy group , while the total uncinectomy group underwent the conventional surgery .


Time required for the uncinectomy , healing period for the uncinectomy site , incidence of lamina papyracea or nasolacrimal duct injury , obstruction or stenosis of the frontal recess , and incidence of synechia formation in the middle meatus were compared between the groups .


All patients completed the follow-up and were included in the analysis .


Surgical indications included chronic maxillary sinusitis , fungal sinusitis , antrochoanal polyp , and odontogenic sinusitis .


Operation durations and healing periods were significantly shorter in the partial uncinectomy group .


One patient had a minor injury to the lamina papyracea and two patients showed partial synechia formations in the total uncinectomy group .


However , other parameters did not differ significantly between the groups .


Partial uncinectomy may be useful in patients with pathological conditions confined to the maxillary sinus .


Shorter operation duration , more rapid healing , and lower incidence of complications are advantages over a conventional total uncinectomy .


Cumulative evidence from epidemiological , preclinical and clinical studies suggests estrogens may have psychoprotective effects in schizophrenic patients .


Selective Estrogen Receptor Modulators could have therapeutic benefits in schizophrenia for both sexes without being hazardous to gynecological tissues or having feminizing effects .


Few studies have been conducted regarding the effects of raloxifene on postmenopausal women suffering from schizophrenia .


We conducted this placebo-controlled trial to compare the add-on effect of raloxifene to risperidone versus risperidone with placebo .


This was an @-week , parallel-group , placebo-controlled trial undertaken at two universities affiliated psychiatric Hospitals in Iran .


Forty-six postmenopausal women with the definite diagnosis of schizophrenia were enrolled in the study .


Patients received risperidone ( @ mg/day in @ divided doses ) combined with either placebo ( N = @ ) or @ mg/day of raloxifene ( N = @ ) for @ weeks .


Patients were assessed by a psychiatrist at baseline and at @ and @ weeks after the start of medical therapy .


Efficacy was defined as the change from baseline to endpoint in score on Positive and Negative Syndrome Scale ( PANSS ) .


For PANSS scores , the main effect comparing two types of intervention was not significant -LSB- F ( @ , @ ) = @ , p = @ -RSB- .


For positive subscale scores , there was marginal significant interaction between intervention type and time -LSB- F ( @ , @ ) = @ , p = @ -RSB- and there was substantial main effect for time -LSB- F ( @ , @ ) = @ , p = @ -RSB- within both groups showing reduction in positive subscale scores across the three time periods .


In addition , the main effect comparing two types of intervention was significant -LSB- F ( @ , @ ) = @ , p = @ -RSB- .


On the other hand , for negative subscale scores , the main effect comparing two types of intervention was not significant -LSB- F ( @ , @ ) = @ , p = @ -RSB- .


For general subscale scores , the main effect comparing two types of intervention was not significant -LSB- F ( @ , @ ) = @ , p = @ -RSB- .


According to our findings , raloxifene as an adjunctive treatment to risperidone was only superior in improvement of positive symptoms and it was not effective in treating negative and general psychopathology symptoms .


We investigated the long-term effects of repetitive transcranial magnetic stimulation ( rTMS ) delivered to the temporoparietal junction and compared contralateral and ipsilateral application in patients with unilateral tinnitus .


Prospective study .


A total of @ patients with asymmetric hearing loss and nonpulsatile chronic tinnitus localized to the poorer ear who were refractory to medical treatment were enrolled .


Patients were randomly assigned to one of two treatment groups : @-Hz stimulation applied to the temporoparietal junction either ipsilaterally ( n = @ ) or contralaterally ( n = @ ) to the symptomatic ear .


Changes in the Tinnitus Handicap Inventory ( THI ) scores and self-rating visual analog scores ( VAS ) for loudness , awareness , and annoyance were analyzed before and after treatment for @ months .


Improved patients were defined as those with decreases in their THI scores by > @ points and @ % .


There were no major complications or worsening of hearing .


When analyzing the THI scores and VAS pre-rTMS and @ months after rTMS , significant decreases were observed in patients overall ( P < @ ) .


For the comparison of long-term outcomes between the ipsilateral and contralateral stimulation groups , there were no differences in the degree of decrease in THI scores or VAS ( P > @ ) .


In addition , there was no significant difference in the rate of patients who improved between the ipsilateral ( @ of @ ) and contralateral ( @ of @ ) stimulation groups ( P = @ ) .


The ipsilateral group showed a more rapid improvement than the contralateral group .


Daily application of @-Hz rTMS to the temporoparietal area is safe and has long-term beneficial effects .


The laterality of stimulation is not the decisive factor .


A prospective endoscopic and radiologic evaluation of long-term outcomes of crushing and crushing with intrinsic stripping , @ minimally destructive techniques used for the surgical treatment of concha bullosa .


Forty-two patients who underwent concha bullosa surgery ( a total of @ conchae surgeries ) were included in the study .


The patients were allocated consecutively to either of the @ groups : Group @ ( crushing , n = @ ) and Group @ ( crushing with intrinsic stripping , n = @ ) .


All procedures were performed endoscopically .


The presurgical and @-year postsurgical endoscopic nasal cavity images and computed tomography ( CT ) scans of all patients were recorded .


Preoperative and postoperative measurements were compared using paired t test and Student t test .


Gender and mean age of the @ patients ( @ conchae bullosa ) were as follows : @ males , mean age @ ( range , @ to @ ) years ; @ females , mean age @ ( range , @ to @ ) years .


The patients were followed for @ @ months .


Comparisons of both the grading of endoscopic images and the concha bullosa volumes measured in CT images before and after treatment showed significant postsurgical reductions in both groups ; comparison between groups showed significant postsurgical decreases for Group @ in both concha bullosa volumes and in endoscopic scoring ( p < @ ) .


Crushing with intrinsic stripping is an effective and easy technique ; when compared to crushing alone ; this technique provides a significantly more decrease in middle concha volumes as demonstrated both by the CT and by endoscopic evaluations .


The premenstrual syndrome ( PMS ) is a series of physical , mental , and behavioral symptoms with various severities , and disturbs social and personal relationships .


The syndrome appears during luteal phase of the menstrual cycle and is a common disorder of reproductive age .


Different treatments have been introduced for the syndrome due to its unknown complicated causes .


Vitamin B@ ( Thiamin ) may reduce symptoms of the syndrome through affecting the performance of coenzymes in the metabolism of carbohydrates and main branch of amino acid that plays an important role in appearance of physical and mental symptoms of the PMS .


Vitamin B@ is the first water-soluble discovered vitamin .


As it is effective in neural activity and muscle tonus in different body activities , including hematopoiesis , metabolism of carbohydrates , activities of the central nervous system and neuromuscular system , etc. , it can be effective in this dysmenorrhea that is a disorder resulting from uterine muscular contraction .


There are no enough studies and research on the effect of vitamin B@ on the symptoms of PMS , therefore , this study was conducted to determine the effect of vitamin B@ on the symptoms of PMS in students residing at dormitories of Jahrom University of Medical Sciences in @ .


In this double-blind placebo-controlled clinical trial , @ students with PMS residing at dormitories of Jahrom University of Medical Sciences were divided randomly into two groups , vitamin B@ and placebo .


The severity of the symptoms of PMS in two cycles , before the intervention and during the intervention , was recorded by the students .


The data were collected using an information collection form , PMS provisional diagnosis form , daily status record form , Beck Depression Inventory .


The data were analyzed using descriptive and inferential statistics .


There was no significant difference among the studied variables in terms of confounding variables .


The comparison of vitamin B@ group before the intervention with that after the intervention showed that vitamin B@ reduced mean mental ( @ % ) and physical ( @ % ) symptoms significantly ( P < @ ) .


Moreover , there was a significant difference between vitamin B@ and placebo groups in terms of mean mental and physical symptoms , as mean symptoms in vitamin B@ group was significantly lower than that in the placebo group ( P < @ ) .


It seems that vitamin B@ is effective in recovery of mental and physical symptoms of PMS .


Therefore , this vitamin can be used to reach a major goal of midwifery , that is , reduction of symptom severity of PMS , without any side effects .


Chronic venous leg ulcers ( CVU ) are a common , unresolved medical problem .


Silica gel fibre ( SGF ) is a novel biodegradable inorganic material developed to serve as a carrier substrate for the local release of pharmaceutical agents facilitating tissue repair .


To assess the performance and safety of SGF in subjects with CVU .


Open , randomized , standard-of-care-controlled , multi-centre trial .


Subjects ( ITT @ patients ) received either SGF in addition to standard treatment or standard-of-care treatment ( S-o-C ) alone .


The primary performance variable was the time to healing of the target ulcer until the end of a @ week treatment period .


SGF was well tolerated .


Mean time to healing up to week @ was @ days for the SGF group ( SE @ ) and @ days for the S-o-C group ( SE @ ) ( p-value = @ ) .


There was no statistically relevant difference regarding the incidence of complete healing of the target ulcers by weeks @ and @ between the SGF and the S-o-C groups ( p-value > @ ) .


SGF is well tolerated and offers a promising perspective as a carrier substrate for the local release of active pharmaceutical agents into the wound site to promote tissue repair .


Genistein from foods or supplements is metabolized by the gut microbiota and the human body , thereby releasing many different metabolites into systemic circulation .


The order of their appearance in plasma and the possible influence of food format are still unknown .


This study compared the nutrikinetic profiles of genistein metabolites .


In a randomized cross-over trial , @ healthy young volunteers were administered a single dose of @ mg genistein provided as a genistein tablet , a genistein tablet in low fat milk , and soy milk containing genistein glycosides .


A high mass resolution LC-LTQ-Orbitrap FTMS platform detected and quantified in human plasma : free genistein , seven of its phase-II metabolites and @ gut-derived metabolites .


Interestingly , a novel metabolite , genistein-@ ' - glucuronide-@-sulfate ( G-@ ` G-@S ) was identified .


Nutrikinetic analysis using population-based modeling revealed the order of appearance of five genistein phase II metabolites in plasma : ( @ ) genistein-@ ' ,@ - diglucuronide , ( @ ) genistein-@-sulfate , ( @ ) genistein-@ ' - sulfate-@-glucuronide , ( @ ) genistein-@ ' - glucuronide , and ( @ ) genistein-@-glucuronide , independent of the food matrix .


The conjugated genistein metabolites appear in a distinct order in human plasma .


The specific early appearance of G-@ ' ,@ - diG suggests a multistep formation process for the mono and hetero genistein conjugates , involving one or two deglucuronidation steps .


Charcot-Marie-Tooth ( CMT ) disease type @A is the most common form of CMT .


The main clinical features are distal weakness , sensory loss , and skeletal deformities .


Although pain is a frequent complaint , small fiber involvement in CMT@A has not been studied extensively .


We assessed pain and small fiber involvement in @ CMT@A patients using a variety of pain scales , pain questionnaires , and thermal thresholds .


Forty-three of @ patients ( @ % ) complained of pain .


The pain was localized to the feet in @ % of patients .


Only @ % of patients had neuropathic pain .


Cold and warm detection thresholds were elevated in @ % and @ % of patients , respectively .


Our findings confirm that CMT@A patients have significant pain , which is more likely to be multifactorial in origin and suggests that a proportion of patients have small fiber dysfunction affecting mainly thinly myelinated A fibers .


Metformin monotherapy is recommended as initial treatment of type @ diabetes .


The selection of optimal second-line therapy that is often necessary due to the progressive nature of the disease is still a subject of ongoing discussions .


The aim of the international EDGE ( Effectiveness of Diabetes control with vildaGliptin and vildagliptin/mEtformin ) study was to prospectively compare the efficacy and safety of vildagliptin vs other oral antidiabetic agents in patients with type @ diabetes not adequately controlled on monotherapy in a real-life clinical setting .


In this paper , we present the data of patients participating in the EDGE study in the Czech Republic .


Patients with type @ diabetes not adequately controlled on monotherapy were enrolled into the study , and randomised into either the vildagliptin arm or control arm with another OAD at the discretion of the treating physician .


Patients with the addition of other incretin-based medications were not enrolled into the study .


The efficiency was evaluated as a proportion of patients reaching the combined endpoint of decreasing HbA@c > @ mmol/mol without hypoglycaemia , peripheral oedema or treatment termination due to gastrointestinal side effects during the @ months of treatment .


@ patients were enrolled into the study in the Czech Republic .


The mean age of the patients when enrolled into the study ( vildagliptin group vs control group ) was @ @ vs @ @ years , mean body mass index was @ @ vs @ @ kg/m@ , mean HbA@c was @ @ vs @ @ mmol/mol .


The probability of reaching the combined primary endpoint ( calculated using a binary logistic regression model to calculate the odds ratios with @ % confidence intervals ) was higher for vildagliptin regardless of baseline HbA@c or type of medication added in the control group .


Primary endpoint was reached by @ % of patients in the vildagliptin group vs @ % of patients in the control group , odds ratio @ ( @ , @ ) ; p < @ .


The proportion of patients reaching secondary endpoint ( HbA@c < @ mmol/mol without hypoglycemic event or weight gain @ % with baseline glycated hemoglobin > @ mmol/mol was higher for vildagliptin @ % vs @ % in the control arm , odds ratio @ ( @ , @ ) , p < @ .


The rate of adverse events was comparable in both groups .


In a real-life clinical set-ting , the percentage of patients reaching the combined endpoint of decreasing HbA@c > @ mmol/mol , without hypoglycaemia , peripheral oedema or treatment termination due to gastrointestinal side effects was higher after the addition of vildagliptin as compared to other antidiabetic agents with comparable rate of side effects .


To evaluate the effect of ozonated oil on palatal wounds .


Eighteen patients were randomized and allocated to either the ozone group ( n = @ ) or control ( n = @ ) group .


Free gingival graft surgery was performed , and post-harvested palatal wounds were treated with either @ mL ozonated oil or control oil daily for @ week .


A planimetrical analysis analyzed the digital image for the wound sizes and shape factor at baseline , at @ h , and days @ , @ , @ , @ , and @ , postoperatively .


A cytological analysis used the keratinization and superficial cell indices at baseline , @ h , and days @ , @ , @ , and @ and the second and third months , postoperatively .


Planimetrical results showed a significant ( P @ ) improvement in wound size on days @ , @ , @ , @ , and @ , postoperatively , in the ozone group compared to the control group .


Cytological results showed a significant ( P @ ) improvement in epithelial healing on days @ , @ , and @ , and the second and third months , postoperatively , after the application of ozonated oil compared to control oil .


Our results showed significant improvement in wound size and epithelial healing after topical ozonated oil application compared to control oil on palatal wounds .


The comparative incidences of hemidiaphragmatic paralysis associated with contemporary ultrasound-guided supraclavicular versus infraclavicular blockade have not received extensive study .


We tested the hypothesis that the infraclavicular approach results in a lower incidence of hemidiaphragmatic paralysis compared with supraclavicular blockade when a standard local anesthetic volume and concentration are used .


With institutional human ethics board approval , we enrolled @ patients undergoing right-sided upper extremity surgery in a randomized , blinded , parallel-group trial .


Patients were assigned to ultrasound-guided supraclavicular or infraclavicular blockade with @ mL of @ % ropivacaine .


The primary end point was complete hemidiaphragmatic paralysis at @ minutes , defined as a greater than @ % reduction in diaphragmatic excursion measured with the voluntary sniff test using M-mode ultrasonography .


Partial paralysis was defined as a @ % to @ % reduction .


Eleven ( @ % ) of @ patients in the supraclavicular group versus @ ( @ % ) of @ in the infraclavicular group had complete hemidiaphragmatic paralysis ( P = @ -LSB- @-tailed -RSB- ; relative risk , @ -LSB- @ % confidence interval , @-@ @ -RSB- ) ; @ % versus @ % had any ( complete or partial ) paralysis ( P = @ ; relative risk , @ -LSB- @ % confidence interval , @-@ @ -RSB- ) .


Eight ( @ % ) of @ patients in the supraclavicular group versus @ ( @ % ) of @ in the infraclavicular group reported dyspnea ( P = @ ) .


Ultrasound-guided supraclavicular blockade with @ mL of @ % ropivacaine produced complete hemidiaphragmatic paralysis in approximately one-third of patients .


The infraclavicular approach greatly reduced this risk but did not eliminate it .


These data may aid in the selection of the approach to brachial plexus blockade , particularly in ambulatory patients and/or those with respiratory comorbidities .


Leucine is a key amino acid involved in the regulation of skeletal muscle protein synthesis .


We assessed the effect of the supplementation of a lower-protein mixed macronutrient beverage with varying doses of leucine or a mixture of branched chain amino acids ( BCAAs ) on myofibrillar protein synthesis ( MPS ) at rest and after exercise .


In a parallel group design , @ men ( @ @ y ) completed unilateral knee-extensor resistance exercise before the ingestion of @ g whey protein ( W@ ) ( @ g leucine ) , @ g whey protein ( W@ ) ( @ g leucine ) , @ g whey protein supplemented with leucine to @ g total leucine ( W@ + Low-Leu ) , @ g whey protein supplemented with leucine to @ g total leucine ( W@ + High-Leu ) , or @ g whey protein supplemented with leucine , isoleucine , and valine to @ g total leucine .


A primed continuous infusion of l - -LSB- ring - ( @ ) C@ -RSB- phenylalanine with serial muscle biopsies was used to measure MPS under baseline fasted and postprandial conditions in both a rested ( response to feeding ) and exercised ( response to combined feeding and resistance exercise ) leg .


The area under the blood leucine curve was greatest for the W@ + High-Leu group compared with the W@ and W@ + Low-Leu groups ( P < @ ) .


In the postprandial period , rates of MPS were increased above baseline over @-@ @ h in all treatments .


Over @-@ @ h , MPS remained increased above baseline after all treatments but was greatest after W@ ( @ % ) and W@ + High-Leu ( @ % ) treatments ( P = @ ) .


A low-protein ( @ g ) mixed macronutrient beverage can be as effective as a high-protein dose ( @ g ) at stimulating increased MPS rates when supplemented with a high ( @ g total leucine ) amount of leucine .


These results have important implications for formulations of protein beverages designed to enhance muscle anabolism .


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


Prucalopride is effective at alleviating symptoms of chronic constipation in women .


The aim of this study was to assess the efficacy of @ weeks of prucalopride treatment compared with placebo in men with chronic constipation .


This was a multicenter , stratified , randomized , parallel-group , double-blind , placebo-controlled , phase @ study ( ClinicalTrials.gov identifier : NCT@ ) .


The primary end point was the proportion of patients with a mean of three or more spontaneous complete bowel movements ( SCBMs ) per week across the treatment period .


Efficacy end points were assessed using daily electronic diaries , global assessment of the severity of constipation and efficacy of treatment , and Patient Assessment of Constipation-Symptoms ( PAC-SYM ) and Patient Assessment of Constipation-Quality of Life ( PAC-QOL ) questionnaires .


In total , @ patients were enrolled in the study .


Significantly more patients achieved a mean of three or more SCBMs per week in the prucalopride group ( @ % ) than in the placebo group ( @ % , P < @ ) .


The proportion of patients rating their constipation treatment as `` quite a bit '' to `` extremely '' effective at the final on-treatment visit was @ and @ % in the prucalopride and placebo groups , respectively .


The difference between treatment groups was statistically significant ( P < @ ) .


The proportion of patients with an improvement of at least @ point in PAC-QOL satisfaction subscale score was @ and @ % in the prucalopride and placebo groups , respectively ( P = @ ) .


Prucalopride had a good safety profile and was well tolerated .


Prucalopride is effective , has a good safety profile , and is well tolerated for the treatment of men with chronic constipation .


People with prediabetes are at increased risk for developing type @ diabetes mellitus .


Weight reduction through lifestyle modification can significantly reduce diabetes risk .


Yet , weight loss varies among individuals and some people do not achieve clinically meaningful weight loss after treatment .


Our aim was to evaluate the time point and threshold for achieving @ % weight loss after completion of a @-week worksite , lifestyle intervention for diabetes prevention .


Weight change before and after the behavioral intervention among participants randomized to the experimental group was examined .


Individuals with prediabetes aged @ to @ years with a body mass index ( calculated as kg/m ( @ ) ) of @ to @ at Ohio State University were eligible .


The @-week , group-based intervention , adapted from the Diabetes Prevention Program , was delivered to @ participants in the experimental group .


Percent weight loss was assessed weekly during the intervention and at @ - and @-month follow-up .


Linear regression modeled the relationship between percent weight loss during month @ of the intervention and percent weight loss at @ and @ months .


Logistic regression modeled failure to lose @ % weight loss at @ and @ months using weekly weight change during the first month of intervention .


Percent weight loss at intervention week @ was significantly associated with percent weight loss at @ and @ months ( all P < @ ) .


Only @ % and @ % of participants who failed to achieve a @ % weight-loss threshold during month @ achieved @ % weight loss at months @ and @ , respectively .


The first month of lifestyle treatment is a critical period for helping participants achieve weight loss .


Otherwise , individuals who fail to achieve at least @ % weight loss may benefit from more intensive rescue efforts or stepped-care interventions .


Mealtime insulin is commonly added to manage hyperglycemia in type @ diabetes when basal insulin is insufficient .


However , this complex regimen is associated with weight gain and hypoglycemia .


This study compared the efficacy and safety of exenatide twice daily or mealtime insulin lispro in patients inadequately controlled by insulin glargine and metformin despite up-titration .


In this @-week , open-label , multicenter , randomized , noninferiority trial with @ weeks prior insulin optimization , @ patients with insufficient postoptimization glycated hemoglobin A@c ( HbA@c ) were randomized to exenatide ( @-@ g/day ) or thrice-daily mealtime lispro titrated to premeal glucose of @-@ @ mmol/L , both added to insulin glargine ( mean @ units/day at randomization ) and metformin ( mean @,@ mg/day ) .


Randomization HbA@c and fasting glucose ( FG ) were @ % ( @ mmol/mol ) and @ mmol/L for exenatide and @ % ( @ mmol/mol ) and @ mmol/L for lispro .


At @ weeks postrandomization , mean HbA@c changes were noninferior for exenatide compared with lispro ( -@ and -@ % , respectively ) ; treatment differences were -@ ( @ % CI -@ , @ ) in per-protocol ( n = @ ) and -@ ( @ % CI -@ , @ ) in intent-to-treat ( n = @ ) populations .


FG was lower with exenatide than lispro ( @ vs. @ mmol/L ; P = @ ) .


Weight decreased with exenatide and increased with lispro ( -@ vs. +@ kg ; P < @ ) .


More patients reported treatment satisfaction and better quality of life with exenatide than lispro , although a larger proportion of patients with exenatide experienced treatment-emergent adverse events .


Exenatide resulted in fewer nonnocturnal hypoglycemic episodes but more gastrointestinal adverse events than lispro .


Adding exenatide to titrated glargine with metformin resulted in similar glycemic control as adding lispro and was well tolerated .


These findings support exenatide as a noninsulin addition for patients failing basal insulin .


We evaluated the effect of the MD-Logic system on overnight glycemic control at patients ' homes .


Twenty-four patients ( aged @-@ years ; average A@c @ @ % , @ @ mmol/mol ) were randomly assigned to participate in two overnight crossover periods , each including @ weeks of consecutive nights : one under closed loop and the second under sensor-augmented pump ( SAP ) therapy at patients ' homes in real-life conditions .


The primary end point was time spent with sensor glucose levels below @ mg/dL ( @ mmol/L ) overnight .


Closed-loop nights significantly reduced time spent in hypoglycemia ( P = @ ) and increased the percentage of time spent in the target range of @-@ mg/dL ( P = @ ) compared with nights when the SAP therapy was used .


The time spent in substantial hyperglycemia above @ mg/dL was reduced by a median of @ % ( interquartile range -LSB- IQR -RSB- @ , @ % ; P = @ ) under closed-loop control compared with SAP therapy .


Overnight total insulin doses were lower in the closed-loop nights compared with the SAP nights ( P = @ ) .


The average daytime glucose levels after closed-loop operation were reduced by a median of @ mg/dL ( IQR -@ , @ ; P = @ ) while lower total insulin doses were used ( P = @ ) .


No severe adverse events occurred during closed-loop control ; there was a single event of severe hypoglycemia during a control night .


The long-term home use of automated overnight insulin delivery by the MD-Logic system was found to be a feasible , safe , and an effective tool to reduce nocturnal hypoglycemia and improve overnight glycemic control in subjects with type @ diabetes .


This study aimed to describe pretreatment patient characteristics and baseline quality-of-life scores as they relate to the development of grade @ or @ toxicity in patients receiving chemotherapy for advanced/recurrent cervical cancer .


The study sample was drawn from Gynecologic Oncology Group protocols @ and @ .


Grade @ or @ toxicities were considered in @ specified categories as follows : peripheral neuropathy , fatigue , hematological , and gastrointestinal ( GI ) .


The data variables explored included age , stage , pretreatment radiation , performance status ( PS ) at treatment initiation , and baseline Functional Assessment of Cancer Therapy-Cervix ( FACT-Cx ) score .


A logistic regression model was developed with various adverse events as binary ( @/@ ) outcomes .


Six hundred seventy-three patient-reported questionnaires were used in the analyses .


At baseline , pain was the most severe patient-reported symptom .


Baseline line-item patient concerns did demonstrate specific correlations with the development of individual toxicities .


In @ patients who were enrolled on Gynecologic Oncology Group @ ( fatigue not measured on @ ) , a worse PS predicted the development of grade @ or @ fatigue ( odds ratio , @ ; @ % confidence interval , @-@ @ ) .


Exposure to previous radiation , treatment regimen , and a worse FACT-Cx score were associated with the reporting of both grade @ or @ leukopenia ( P < @ ) and anemia ( P < @ ) .


Performance status and treatment regimen ( P < @ ) were associated with the development of grade @ or @ thrombocytopenia .


Age and treatment regimen ( P < @ ) were associated with the development of grade @ or @ neutropenia .


The FACT-Cx score ( P = @ ) predicted grade @ or @ GI toxicity .


The development of fatigue , hematological , and GI toxicity might be predictable based on factors other than treatment assignment such as age , PS , and patient-reported quality-of-life measurement .


The ongoing scale-up of antiretroviral therapy ( ART ) in sub-Saharan Africa has prompted the interest in surveillance of transmitted and acquired HIV drug resistance .


Resistance data on virological failure and mutations in HIV infected populations initiating treatment in sub-Saharan Africa is sparse .


HIV viral load ( VL ) and resistance mutations pre-ART and after @ months were determined in a prospective cohort study of ART-nave HIV patients initiating first-line therapy in Jimma , Ethiopia .


VL measurements were done at baseline and after @ and @ months .


Genotypic HIV drug resistance ( HIVDR ) was performed on patients exhibiting virological failure ( > @ copies/mL at @ months ) or slow virological response ( > @ copies/mL at @ months and < @ copies/mL at @ months ) .


Two hundred sixty five patients had VL data available at baseline and at @ months .


Virological failure was observed among @ ( @ % ) participants out of @ patients .


Twelve samples were genotyped and six had HIV drug resistance ( HIVDR ) mutations at baseline .


Among virological failures , @/@ ( @ % ) harbored one or more HIVDR mutations at @ months .


The most frequent mutations were K@N and M@VI .


Our data confirm that the currently recommended first-line ART regimen is efficient in the vast majority of individuals initiating therapy in Jimma , Ethiopia eight years after the introduction of ART .


However , the documented occurrence of transmitted resistance and accumulation of acquired HIVDR mutations among failing patients justify increased vigilance by improving the availability and systematic use of VL testing to monitor ART response , and underlines the need for rapid , inexpensive tests to identify the most common drug resistance mutations .


Mirror therapy ( MT ) and electromyography-triggered neuromuscular stimulation ( ETMS ) are both effective treatments for impaired upper limbs following stroke .


A combination of these two treatments ( ETMS-MT ) may result in greater gain than either treatment alone .


The feasibility and possible effects of ETMS-MT upon upper extremity function were investigated in stroke patients .


Thirteen post-acute stroke patients were randomly assigned to an immediate ETMS-MT group or a delayed ETMS-MT group and then underwent an @-week training program .


The immediate ETMS-MT group received ETMS-MT in addition to physical and occupational therapy ( PT+OT ) for @ weeks .


They then received only PT+OT for the next @ weeks .


In the delayed ETMS-MT group , interventions were provided in the reverse order .


The main outcome measure was the Fugl-Meyer Assessment ( FMA ) .


The immediate ETMS-MT group showed significantly greater gain in FMA in the first @ weeks .


The delayed ETMS-MT group showed significantly greater gain in active range of motion during the latter @ weeks .


No adverse effects were reported following ETMS-MT .


ETMS-MT might be as effective as independent MT or ETMS without causing any side effects .


Future research should focus upon the direct comparisons between independent and combined interventions .


Gold-standard assessment of acute wound healing has traditionally been through histological analysis of biopsied tissue .


However , this process is invasive with recognized side-effects .


Optical coherence tomography ( OCT ) is a noninvasive technique generating high-resolution real-time images of cutaneous architecture .


To compare OCT with histological assessment of in vivo acute wound healing and ascertain the level of agreement between modalities for measurement of defined cutaneous structures .


Punch biopsies ( @mm ) were harvested from @ healthy volunteers .


Wounds healed by secondary intention until they were re-excised @ , @ , @ or @days later depending on random group allocation .


Wounds were assessed weekly for @weeks using OCT and compared with histological findings derived from time-matched biopsies .


Dimensions of four cutaneous structures were measured using both modalities and the level of agreement was established by Bland-Altman analysis .


The mean greyscale value ( MGV ) of the upper reticular dermis was derived from OCT images at all time points .


Both techniques showed anatomical congruity in normal and wounded skin with correlating architectural changes associated with inflammatory , proliferative and remodelling wound healing phases .


MGV was significantly increased @weeks after wounding ( P = @ ) and may represent a novel measure of wound fibrosis .


Despite good association of histomorphometric values with low but consistent bias ( range -@ to @m ) , Bland-Altman plots demonstrated poor agreement between OCT and histology .


Optical coherence tomography enabled accurate assessment of healing tissue comparable with histological analysis of biopsy specimens .


This noninvasive tool is highly suited to wound assessment and may represent a diagnostic alternative to punch biopsies .


Obstructive sleep apnea ( OSA ) is commoner in patients with fluid-retaining states than in those without fluid retention , in men than in women , and worsens with aging .


In men , OSA severity is related to the amount of fluid shifting out of the legs overnight , but a cause-effect relationship is not established .


Our objective was to test the hypothesis that mimicking fluid overload during sleep would increase severity of OSA more in older ( @ years ) than in younger men ( < @ years ) .


Randomized , single-blind , double crossover study .


Research sleep laboratory .


Seven older and @ younger men with non-severe or no sleep apnea , matched for body mass index .


During the control arm , normal saline was infused to keep the vein open .


During intervention , subjects received an intravenous bolus of normal saline ( @ mL/kg body weight ) after sleep onset while they were wearing compression stockings to prevent fluid accumulation in the legs .


Compared to younger men , infusion of similar amounts of saline in older men caused a greater increase in neck circumference ( P < @ ) and in the AHI ( @ @ vs. @ @ , P = @ ) .


Older men are more susceptible to the adverse effects of intravenous fluid loading on obstructive sleep apnea severity than younger men .


This may be due to age-related differences in the amount of fluid accumulating in the neck or upper airway collapsibility in response to intravenous fluid loading .


These possibilities remain to be tested in future studies .


Biopsy confirmed that cervical intraepithelial neoplasia ( CIN ) may naturally regress or progress .


Currently , the risk assessment for CIN progression to cervical cancer is still not satisfactory in clinical practice .


We investigated copy number and protein expression of TP@ and MYC and explored the possibility to use them as progression biomarkers .


Copy numbers of TP@ and MYC , as well as human papilloma virus ( HPV ) integration status , were determined by fluorescence in situ hybridization in @ patients with CIN and @ patients with cervical cancer .


Corresponding protein expressions were analyzed by immunohistochemistry .


Receiver operating characteristic curves were used to measure the diagnostic test performance for the detection of cervical cancer from CIN .


Sensitivity and specificity values of biomarkers were calculated .


The average copy number and expression of TP@ and MYC , as well as the HPV integration rate , increased in the progression of CIN to cervical cancer .


Receiver operating characteristic analysis for detection of cervical cancer resulted in area under the curve ( AUC ) values of TP@ copy number ( AUC , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) , MYC copy number ( AUC , @ ; @ % CI , @-@ @ ) , TP@ expression ( AUC , @ ; @ % CI , @-@ @ ) , and HPV-@ integration ( AUC , @ ; @ % CI , @-@ @ ) .


MYC expression was not able to statistically distinguish cancer from CIN ( P = @ ) .


The combinations increased the specificity slightly but not sensitivity .


Among them , TP@ amplification showed the best diagnostic performance .


Amplification and overexpression of TP@ and MYC , and HPV integration rate , are associated with the transition of CIN to cervical cancer .


Future studies on these biomarkers will help to assess the risk of CIN progression .


Discontinuations and/or interruptions in aspirin therapy for secondary cardioprotection due to upper gastrointestinal ( UGI ) complications or symptoms have been shown to increase the risk for subsequent cardiovascular events .


PA@ is a coordinated-delivery , combination tablet consisting of enteric-coated aspirin ( EC-ASA ) @ mg and immediate-release ( IR ) omeprazole @ mg .


Two identically-designed , @-month , randomized , double-blind trials evaluated PA@ vs. EC-ASA @ mg in a secondary cardiovascular disease prevention population taking aspirin @ mg daily for @ months and at risk for ASA-associated gastric ulcers ( GUs ) .


The combined study population was @ subjects ( @ randomized to PA@ , @ to EC-ASA @ mg ) .


The primary endpoint was the occurrence of endoscopically-determined gastric ulceration over @ months .


Safety outcomes included the rates of major adverse cardiovascular events ( MACE ) and UGI symptoms .


Significantly fewer PA@-treated subjects ( @ % ) developed endoscopic GUs vs. EC-ASA @ mg-treated subjects ( @ % ) ( P < @ ) .


Overall occurrence of MACE was low ( @ % ) , with no significant differences between treatments in types or incidence of MACE .


PA@-treated subjects had significantly fewer UGI symptoms ( P < @ ) and significantly fewer discontinuations due to pre-specified UGI adverse events ( @ % vs. @ % , respectively ; P < @ ) .


PA@ reduced the incidence of endoscopic GUs compared to EC-ASA @ mg , but with a similar cardiovascular event profile .


Due to fewer UGI symptoms , continuation on aspirin therapy was greater in the PA@ treatment arm .


Anaphylaxis is a life-threatening emergency .


If promptly administered , adrenaline is potentially life-saving .


Many food-allergic-children/carers are unsure when to use their adrenaline autoinjectors , contributing to a low quality of life and worse outcomes in the setting of an acute allergic reaction .


The aim of this study was to assess the effectiveness of @-hour telephone access to specialist clinical advice on disease-specific quality of life .


A pragmatic two-arm , parallel-group randomized control trial was conducted .


Children/carers ( < @years ) with food allergy , trained in adrenaline auto-injector use , were recruited from a hospital-based paediatric allergy clinic .


Baseline disease-specific quality of life was ascertained using the validated Food-Allergy-Related Quality-of-Life Questionnaire ( FAQLQ ) , either Parent Form , Child Form or Teenager Form depending on child 's age .


Participants were then centrally randomized for a @-month period to @-hour telephone specialist support line or to usual care .


The primary outcome measure was a change in FAQL scores , at one and @months postrandomization , compared with baseline .


The minimum clinically important difference ( MCID ) in score is @ .


Fifty two children/carers were recruited .


FAQL scores remained static in the control group across the three time points .


Scores gradually improved in the intervention group , with a significant difference seen at @months ( T@-T@ Mean difference = -@ , ( CI @-@ @ ) P < @ -RSB- Follow-up questionnaires , @months after the intervention was removed , T@ , showed sustained significant difference between the groups ( control M = @ ; intervention M = @ -LSB- t = -@ , P < @ -RSB- ) .


The @-hour helpline improved food-allergy-specific quality of life in children .


Six-month intervention support resulted in sustained benefits for at least a further @months .


To evaluate the effects of prone position ventilation combined with recruitment maneuvers ( RM ) on clinical outcomes in patients with severe acute respiratory distress syndrome ( ARDS ) .


In this prospective , randomized , controlled trial , we randomly assigned @ sequential patients with severe ARDS to the intervention group ( which undergo prone-positioning with RM sessions of at least @ hours ) or to the control group ( which be left in the supine position ) .


From July @ to July @ , @ severe ARDS patients sequentially admitted to the critical department of Peking Union Medical College Hospital were enrolled in the study with @ patients assigned to the control group and @ patients to the intervention group .


No significant difference was found between the two groups in the demographics including the median patient age , sex ratio , initial Acute Physiology and Chronic Health Evaluation II scores , initial pulmonary function and the sources of ARDS .


The oxygenation index recorded in the supine position was significantly higher in the intervention group than in the control group since day @ , whereas the positive end-expiratory pressure and fraction of inspired O@ were significantly lower in the intervention group .


The plateau pressure and static compliance of the respiratory system were similar in the two groups .


The intervention group had shorter length of ICU stay , fewer ventilation days and decreased @-day mortality than the control group .


The tracheotomy ratio and the time to successful extubation were similar in the two groups .


No significant difference between the two groups was shown in the incidence of complications , except for the grade @ pressure sore , which was higher in the intervention group .


In patients with severe ARDS , application of prolonged prone-positioning with RM sessions significantly improves the clinical outcomes .


Diets rich in fermentable residues increase intestinal gas production .


Our aim was to demonstrate the potential effects of diet on gas-related symptoms .


The effect of a low-flatulogenic test diet ( restricted to foodstuffs low in fermentable residues ; n = @ ) was compared to that of a balanced control diet ( Mediterranean type ; n = @ ) in @ patients complaining of flatulence and other abdominal symptoms using a randomized parallel design .


The following outcomes were measured daily : number of anal gas evacuations by an event marker , severity of gas-related symptoms by @-@ scales , and sensation of digestive comfort by a -@ ( unpleasant ) to +@ ( pleasant ) scale .


Measurements were taken pretreatment for @days on their habitual diet and for @days during the treatment phase .


No pretreatment differences were detected between patients allocated to the control or test diets .


The test diet significantly reduced the number of gas evacuations ( by @ % ; p = @ vs basal diet ) whereas the control diet had a lesser effect ( reduction by @ % ; p = @ vs basal diet ; p = @ vs test diet ) .


Compared to the control diet , the test diet significantly reduced flatulence ( by @ % vs @ % , respectively ; p = @ ) , abdominal distension ( by @ % vs @ % , respectively ; p = @ ) , and enhanced digestive well-being ( by @ % vs @ % , respectively ; p = @ ) .


In patients with gas-related symptoms , a low-flatulogenic diet produces immediate beneficial effects with digestive , cognitive , and emotive dimensions .


The number of gas evacuations is an objective biological marker of response to dietary treatment .


To examine the efficacy of an integrative yoga programme as adjuvant treatment of essential arterial hypertension .


An Integrative yoga programme was conducted during three months in @ sessions with a group of ten essential arterial hypertension patients at a public health centre .


The same number of patients acted as the control group without treatment .


The patients were randomly selected and assigned to the groups .


All patients filled in the Positive and Negative Affect Schedule ( PANAS ) , the Hospital Anxiety and Depression Scale ( HADS ) and the Smith Relaxation States Inventory @ ( SRSI@ ) before and after the treatment .


A statistically significant reduction of systolic and diastolic blood pressure , negative affect , symptoms of anxiety and degree of stress could be observed in the study group .


These positive and promising results confirm the effectiveness of these techniques in the treatment of essential arterial hypertension and suggest possible further investigations .


To test if TIA/stroke electronic decision support in primary care improves management .


Multicenter , single-blind , parallel-group , cluster randomized , controlled trial comparing TIA/stroke electronic decision support guided management with usual care .


Main outcomes were guideline adherence and @-day stroke risk .


Secondary outcomes were cerebrovascular/vascular/death / adverse events , cost , and user feedback .


Main analysis was logistic regression with a normal random effect for clusters using a generalized linear mixed model .


Twenty-nine clinics were randomized to intervention , @ to control , recruiting @ and @ eligible patients .


More intervention patients received guideline-adherent care ( @/@ ; @ % ) than control patients ( @/@ ; @ % ) ( adjusted odds ratio -LSB- OR -RSB- @ ; @ % confidence interval -LSB- CI -RSB- @-@ @ ; p < @ ) .


Ninety-day stroke occurred in @/@ ( @ % ) intervention and @/@ ( @ % ) control patients ( OR @ ; @ % CI @-@ @ ; p = @ ) .


Ninety-day TIA or stroke occurrence was lower in the intervention group , @/@ ( @ % ) compared to @/@ ( @ % ) control ( adjusted OR @ ; @ % CI @-@ @ ; p = @ ) .


Fewer vascular events/deaths occurred in intervention , @/@ ( @ % ) , than in control patients , @/@ ( @ % ) ( adjusted OR @ ; @ % CI @-@ @ ; p = @ ) .


Treatment cost ratio of @ ( @ % CI @-@ @ ; p = @ ) favored the intervention without increased adverse events .


Clinician feedback was positive .


Primary care use of the TIA/stroke electronic decision support tool improves guideline adherence , safely reduces treatment cost , achieves positive user feedback , and may reduce cerebrovascular and vascular event risk following TIA/stroke .


This study provides Class II evidence that a primary care electronic decision support tool improves guideline adherence and might reduce @-day stroke risk .


Nicotine is a known analgesic .


Our primary aim was to test the hypothesis that intranasal nicotine administered intraoperatively reduces the need for postoperative opioids .


The secondary outcomes included evaluation of both postoperative pain and nausea and vomiting ( PONV ) .


Nonsmoking female patients undergoing laparoscopic bariatric operations were randomized to receive either @ mg intranasal nicotine ( N = @ ) or placebo spray ( N = @ ) at the conclusion of surgery .


Postoperative opioid use converted to intravenous morphine equivalents ( iv MEQ ) and PONV rates were recorded during both the recovery room postanesthesia care unit ( PACU ) stay and the first @ postoperative hours .


All patients received multimodal antiemetic prophylaxis .


Total iv MEQ were not significantly reduced during the PACU stay in patients receiving nicotine ( median -LSB- interquartile range ( IQR ) -RSB- , @ -LSB- @ , @ -RSB- mg for nicotine vs. @ -LSB- @ , @ -RSB- mg for placebo , one-tailed P = @ ) or for the first @ h following PACU discharge ( @ -LSB- @ , @ -RSB- mg for nicotine vs. @ -LSB- @ , @ -RSB- mg for placebo , one-tailed P = @ ) .


For the combined period ( PACU + @-h post-PACU discharge ) , iv MEQ were @ -LSB- @ , @ -RSB- mg for nicotine and @ -LSB- @ , @ -RSB- mg for placebo , one-tailed P = @ .


Compared to placebo , a higher percentage of patients administered nicotine received antiemetics in the PACU ( @ vs. @ % , P = @ ) .


Intraoperative intranasal nicotine did not exhibit opioid-sparing effect in nonsmoking bariatric female patients .


Despite antiemetic prophylaxis , the use of nicotine was associated with the higher frequency of the use of rescue antiemetics in PACU .


To study the effect of Shugan Jiangu Recipe ( SJR ) on bone mineral density ( BMD ) and serum bone metabolic biochemical markers in postmenopausal breast cancer patients with osteopenia .


Totally @ patients of postmenopausal women with breast cancer , who received aromatase inhibitors ( AIs ) , were assigned to the treatment group ( @ cases ) and the control group ( @ cases ) by using random digit table .


All patients took Caltrate D Tablet ( containing Ca @ mg and Vit D@ @ IU ) , one tablet daily .


Patients in the treatment group took SJR , @ g each time , twice daily for @ successive months .


The bone mineral density ( BMD ) level was detected before treatment and at months @ after treatment .


Levels of bone alkaline phosphatase ( BALP ) , bone gla protein ( BGP ) , tartrate-resistant acid phosphatase ( TRAP ) , and C-terminal telopeptide of type II collagen ( CTX-II ) were detected by enzyme linked immunosorbent assay ( ELISA ) .


The drug safety was also assessed .


Compared with before treatment , BMD of L@-@ and femur neck obviously increased in the treatment group at month @ after treatment ( P < @ ) , serum BALP and TRAP decreased ( P < @ ) .


Compared with before treatment , BMD of L@-@ and femur neck obviously decreased in the control group at month @ after treatment ( P < @ ) , serum BALP and TRAP increased ( P < @ ) .


Compared with the control group , lumbar and femur neck BMD obviously increased , serum levels of BGP and BALP obviously decreased , and serum levels of CTX-II and TRAP obviously increased in the treatment group at month @ after treatment ( P < @ ) .


No serious adverse event occurred during the treatment period .


Bone fracture occurred in one case of the control group ( @ % ) .


SJR could attenuate bone loss of postmenopausal women with breast cancer who received AIs , increase BMD and improve abnormal bone metabolism .


School-based influenza immunization can effectively address accessibility barriers , but injected inactivated influenza vaccines ( IIV ) may not be acceptable to some children and parents in school settings .


To better understand the feasibility of offering intranasal live attenuated influenza vaccines ( LAIV ) through schools , we assessed uptake , stakeholder acceptability , and cost of school-based delivery of LAIV compared to IIV .


We piloted an open-label cluster randomized trial involving @ elementary schools in Peterborough , Ontario during the @-@ influenza vaccination campaign .


Schools were randomized to having students receive IIV or LAIV at publicly-funded school-based clinics organized by the local public health department .


We measured the percentage of students vaccinated with at least one dose of influenza vaccine at school .


Stakeholder acceptability was evaluated through a questionnaire of parents and interviews of public health department personnel and school principals .


We compared the costs per dose of vaccine administered , including staff time and costs of vaccines and supplies .


Single-dose influenza vaccine uptake was higher for the five schools offering LAIV than for the five offering IIV ( @ % vs. @ % , p = @ ) .


Interviews with nine school principals and five public health department personnel suggested that the clinics ran smoothly with little disruption to school routines , and that LAIV was associated with increased efficiency and calmer children .


All interviewees cited unfamiliarity with LAIV and the study recruitment package length as potential reasons for low uptake .


The cost per vaccine dose administered was $ @ for IIV and $ @ for LAIV .


Use of LAIV in school-based clinics was associated with increased vaccine uptake and the perception among immunizing staff of reduced child anxiety , but also slightly higher vaccine administration costs , compared to IIV .


However , uptake was low for both groups .


More effective strategies to promote influenza vaccines and to obtain parent consent may improve vaccine uptake .


To assess the long-term effects of an intensive lifestyle intervention on physical function using a randomized post-test design in the Look AHEAD trial .


Overweight and obese ( BMI @ kg m ( -@ ) ) middle-aged and older adults ( aged @-@ years at enrollment ) with type @ diabetes ( n = @ ) at four clinics in Look AHEAD , a trial evaluating an intensive lifestyle intervention ( ILI ) designed to achieve weight loss through caloric restriction and increased physical activity compared to diabetes support and education ( DSE ) , underwent standardized assessments of performance-based physical function including an expanded short physical performance battery ( SPPBexp ) , @-m and @-m walk , and grip and knee extensor strength @ years post-randomization , during the trial 's weight maintenance phase .


Eight years post-randomization , individuals randomized to ILI had better SPPBexp scores -LSB- adjusted mean ( SE ) difference : @ ( @ ) , P = @ -RSB- and faster @-m and @-m walk speeds -LSB- @ ( @ ) m s ( -@ ) , P = @ , and @ ( @ ) m s ( -@ ) , P = @ , respectively -RSB- compared to those randomized to DSE .


Achieved weight loss greatly attenuated the group differences in physical function , and the intervention effect was no longer significant .


An intensive lifestyle intervention has long-term benefits for mobility function in overweight and obese middle-aged and older individuals with type @ diabetes .


Although children vaccinated with heptavalent pneumococcal conjugate vaccine ( PCV ) had fewer episodes of acute otitis media ( AOM ) , this trial was unable to prove a simultaneous decrease in nasopharyngeal carriage .


Carriage rates of AOM pathogens in the nasopharynx are high among children , and colonization is the first step towards infection .


The possible impact of PCV on carriage is therefore of interest , particularly in children with recurrent AOM .


The aims of this study were to examine the effect of heptavalent PCV on carriage of AOM pathogens in children at high risk of developing recurrent disease , and to monitor carriage of resistant pathogens in vaccinated and unvaccinated children .


A total of @ children with an onset of AOM before @ months of age , @ of whom developed recurrent disease , were enrolled in a trial .


Fifty-two children were vaccinated and all were closely monitored for @ years .


There was no difference statistically between vaccinated children and controls concerning the carriage of any of the major AOM pathogens .


There was evidence of within-child clustering for S. pneumoniae ( p = @ ) and H. influenzae ( p < @ ) , indicating that children continued to carry either species over time .


Resistance rates were generally low and comparable with national levels .


Locoregional anesthesia is an effective method for evaluating cerebral function during carotid endarterectomy ( CEA ) .


Landmark-guided regional anesthesia ( RA ) is currently used for CEA and can provoke substantial perioperative hypertension .


Ultrasound-guided RA ( US-RA ) is a new method for performing RA in CEA ; however , the effect on sympathetic activity and blood pressure is uncertain .


This study assessed early sympathetic activity during CEA in US-RA compared with general anesthesia ( GA ) .


Patients were prospectively randomized to receive US-RA ( n = @ ) or GA ( n = @ ) for CEA .


The primary end point was the change in systolic arterial blood pressure after induction of anesthesia ( just before starting surgery ) comparing US-RA with GA. .


We also recorded heart rate and analyzed concentrations of plasma blood hormones , including cortisol , metanephrine , and normetanephrine at five different times .


Creatinine kinase , troponin I , and N-terminal pro-B-type natriuretic peptide were analyzed to detect potential changes in cardiac biomarkers during the procedure .


Systolic arterial blood pressure ( mean standard deviation ) increased significantly in US-RA patients compared with GA patients even before surgery was initiated ( @ @ mm Hg vs @ @ mm Hg ; P < @ ) , then remained elevated during the entire surgery and returned to baseline values @ hour after admission to the postoperative anesthesia care unit .


Heart rate ( US-RA : @ @ beats/min , GA : @ @ beats/min ; P < @ ) and cortisol levels ( US-RA : @ @ g/L , GA : @ @ g/L ; P = @ ) were also significantly higher in the US-RA group after induction of anesthesia .


Other values did not differ .


The US-RA technique for CEA induces temporary intraoperative hypertension and an increase in stress hormone levels .


Nevertheless , US-RA is a feasible , effective , and safe form of locoregional for CEA that enables targeted placement of low volumes of local anesthesia under direct visualization .


Adults living in the sunny Australian climate are at high risk of skin cancer , but vitamin D deficiency ( defined here as a serum @-hydroxyvitamin D ( @ ( OH ) D ) concentration of less than @ nmol/L ) is also common .


Vitamin D deficiency may be a risk factor for a range of diseases .


However , the optimal strategies to achieve and maintain vitamin D adequacy ( sun exposure , vitamin D supplementation or both ) , and whether sun exposure itself has benefits over and above initiating synthesis of vitamin D , remain unclear .


The Sun Exposure and Vitamin D Supplementation ( SEDS ) Study aims to compare the effectiveness of sun exposure and vitamin D supplementation for the management of vitamin D insufficiency , and to test whether these management strategies differentially affect markers of immune and cardio-metabolic function .


The SEDS Study is a multi-centre , randomised controlled trial of two different daily doses of vitamin D supplementation , and placebo , in conjunction with guidance on two different patterns of sun exposure .


Participants recruited from across Australia are aged @-@ years and have a recent vitamin D test result showing a serum @ ( OH ) D level of @-@ nmol/L .


This paper discusses the rationale behind the study design , and considers the challenges but necessity of data collection within a non-institutionalised adult population , in order to address the study aims .


We also discuss the challenges of participant recruitment and retention , ongoing engagement of referring medical practitioners and address issues of compliance and participant retention .


Patching of the operative eye is occasionally used in pediatric strabismus surgery .


The primary purpose of this study was to investigate the psychological and physiologic effects of patching after operation by multifactorial methods .


We analyzed the perioperative behaviors of @ children with strabismus conducted from June @ to July @ in this prospective longitudinal study .


The children were randomized into @ groups .


Patients in the patching group underwent postoperative patching and others received no patching .


Main outcome measures included The Faces Pain Scale-Revised score or numerical rating scales score , Children 's Hospital of Eastern Ontario Pain Scale ( CHEOPS ) score , crying time , and preoperative and postoperative physiologic parameters .


Crying time was significantly longer in the patching group than in the no patching group , but self-report scores showed no difference in the groups .


Repeated-measures analysis of variance on ranks revealed that postoperative CHEOPS score was lower in the no patching group than in the patching group , whereas no physiologic parameters were significantly different in the @ groups .


Patching is not necessary for reducing postoperative pain or the risk of infection in children undergoing strabismus surgery .


To assess the effect of a physical activity ( PA ) intervention on brain and behavioral indices of executive control in preadolescent children .


Two hundred twenty-one children ( @-@ years ) were randomly assigned to a @-month afterschool PA program or a wait-list control .


In addition to changes in fitness ( maximal oxygen consumption ) , electrical activity in the brain ( P@-ERP ) and behavioral measures ( accuracy , reaction time ) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility .


Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control ( @ mL/kg per minute , @ % confidence interval -LSB- CI -RSB- : @ to @ ; d = @ for group difference in pre-to-post change score ) .


Intervention participants exhibited greater improvements from pretest to posttest in inhibition ( @ % , @ % CI : @ to @ ; d = @ ) and cognitive flexibility ( @ % , @ % CI : @ to @ ; d = @ for group difference in pre-to-post change score ) compared with control .


Only the intervention group increased attentional resources from pretest to posttest during tasks requiring increased inhibition ( @ V , @ % CI : @ to @ ; d = @ ) and cognitive flexibility ( @ V , @ % CI : @ to @ ; d = @ ) .


Finally , improvements in brain function on the inhibition task ( r = @ ) and performance on the flexibility task correlated with intervention attendance ( r = @ ) .


The intervention enhanced cognitive performance and brain function during tasks requiring greater executive control .


These findings demonstrate a causal effect of a PA program on executive control , and provide support for PA for improving childhood cognition and brain health .


Recurrent and/or metastatic squamous cell carcinoma of the head and neck ( R/M-SCCHN ) overexpresses v@ integrin .


Cilengitide selectively inhibits v@ and v@ integrins and is investigated as a treatment strategy .


The phase I/II study ADVANTAGE evaluated cilengitide combined with cisplatin , @-fluorouracil , and cetuximab ( PFE ) in R/M-SCCHN .


The phase II part reported here was an open-label , randomized , controlled trial investigating progression-free survival ( PFS ) .


Patients received up to six cycles of PFE alone or combined with cilengitide @ mg once ( CIL@W ) or twice ( CIL@W ) weekly .


Thereafter , patients received maintenance therapy ( cilengitide arms : cilengitide plus cetuximab ; PFE-alone arm : cetuximab only ) until disease progression or unacceptable toxicity .


One hundred and eighty-two patients were treated .


Median PFS per investigator read was similar for CIL@W + PFE , CIL@W + PFE , and PFE alone ( @ , @ , and @ months , respectively ) .


Accordingly , median overall survival and objective response rates were not improved with cilengitide ( @ months/@ % , @ months/@ % , and @ months/@ % , respectively ) .


No clinically meaningful safety differences were observed between groups .


None of the tested biomarkers ( expression of integrins , CD@ , Ki-@ , vascular endothelial growth factor receptor @ , vascular endothelial-cadherin , type IV collagen , epidermal growth factor receptor , or p@ for human papillomavirus ) were predictive of outcome .