GI tolerance was similar and anthropometric z-scores were < @ SD from the WHO growth standards in all groups , while urinary hydration markers were within normal range for all FF infants .


Increasing sn-@ palmitate in infant formula reduces stool palmitate soaps .


A combination of high sn-@ palmitate and OF reduces stool palmitate soaps , total soaps and calcium , while promoting softer stools .


A number of studies have evaluated the effects of subcutaneous drainage during digestive surgery .


All of the previous studies assessed the usefulness of active-suctioning drain , including two randomized controlled studies which found no benefit for the placement of active-suctioning drains in digestive surgery .


The utility of passive drainage has not been evaluated previously .


The purpose of this study was to evaluate the efficacy of subcutaneous passive drainage system for preventing surgical site infections during major colorectal surgery .


A total of @ patients who underwent major colorectal surgery were enrolled in this study .


Patients were randomly assigned to receive subcutaneous passive drainage or no drainage .


The primary outcome measured was the incidence of superficial surgical site infections .


The secondary outcomes measured were the development of hematomas , seromas , and wound dehiscence .


Finally , a total of @ patients ( @ underwent passive drainage , and @ underwent no drainage ) were included in the analysis after randomization .


There was a significant difference in the incidence of superficial surgical site infections between patients assigned to the passive drainage and no drainage groups ( @ % vs @ % , respectively , P = @ ) .


There were no cases that developed a hematoma , seroma , or wound dehiscence in either group .


A subgroup analysis revealed that male gender , age @ years , diabetes mellitus , American Society of Anesthesiologists ( ASA ) status @ , blood loss @ ml , and open access were factors that were associated with a beneficial effect of subcutaneous passive drainage .


Subcutaneous passive drainage provides benefits over no drainage in patients undergoing major colorectal surgery .


The aim of this study was to elucidate the physiological adjustment effect of forest therapy based on the Law of Initial Value .


The experiments were conducted in nine forest and urban areas in Japan during the period from @ to @ .


There were @ male Japanese university students participating in each of the nine experiments ( total , @ participants ) .


Of these , @ subjects ( mean age standard deviation , @ @ years ) were analyzed .


The subjects were instructed to view a real forest landscape or urban area for @ min .


The systolic blood pressure , diastolic blood pressure , and pulse rate of each subject were measured .


We analyzed the correlation between the initial values ( after city viewing ) and the differences in values between the two environments ( after forest viewing-after city viewing ) .


There was a negative correlation between the initial values and the differences in values between the two environments .


The subjects whose initial systolic blood pressure , diastolic blood pressure , and pulse rate were high showed marked decreases in these parameters as their response after viewing the forest environment , whereas those whose initial systolic blood pressure , diastolic blood pressure , and pulse rate were low showed increases in these parameters as their response .


These results support the premise that the physiological effect of a forest environment can differ depending on a subject 's initial response values .


Moreover , it was clear that forest therapy caused physiological adjustment , normalizing blood pressure and pulse rate .


The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation .


The face mask and endotracheal tube are the devices used to achieve this goal .


Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing > @,@ g or delivered @weeks ' gestation .


A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials ( RCTs ) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation ( @ % ) compared to the group using face masks ( @ % ) .


However , there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists.Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives , nurses , and pediatricians .


The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation .


This will be an open , prospective , randomized , single center , clinical trial .


In this study , @ newborns weighing > @,@ g or delivered @weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway ( LMA SupremeTM , LMA Company , UK - intervention group ) or with a face mask ( control group ) .


Proportion of newborns needing endotracheal intubation .


Apgar score at @minutes , time to first breath , onset of the first cry , duration of resuscitation , death or moderate to severe hypoxic-ischemic encephalopathy within @days of life .


Hypertonic citrate adenine ( HC-A ) solution , containing citrate and adenine , has become the most widely used preservation solution in isolated kidney preservation in China .


More than @ years of clinical application has demonstrated that HC-A is safe and effective .


With higher requirement for kidney preservation and less tolerance of preservation-related graft dysfunction , a new solution , HC-A II , for kidney preservation was developed by Shanghai Changzheng Hospital .


Upon approval from the State Food and Drug Administration of China ( SFDA ) , a multi-center randomized controlled trial was performed to study the efficacy and safety of HC-A II in kidney preservation from @ to @ , using histidine-tryptophan-ketoglutarate solution ( HTK ) as control ( HC-A , n = @ , and HTK , n = @ ) .


There were no differences with regard to donor and recipient demographics or cold ischemia .


The trial results showed no significant difference in DGF rate , or patient or graft survival between the @ groups .


No significant difference between the @ groups was found in the percentage of patients whose serum creatinine ( SCr ) test results returned to normal within @ days ( P > @ ) , nor were there a significant difference in safety evaluation ( P > @ ) .


HC-A II and HTK appear to have similar efficacy in isolated kidney preservation .


Prevention research has to elucidate how families with overweight children can be convinced to participate in obesity intervention trials .


Here we describe the detailed recruitment process for a telephone-based obesity prevention programme for families with overweight children and present participation rates , the study design and a socio-demographic description of participating families .


Overweight ( BMI > @th percentile ) children and adolescents @-@ years of age were screened via the German paediatrician network CrescNet .


The prevention programme ( multiple computer aided telephone counselling interviews ) was suggested to eligible families via local paediatricians .


Participating families were compared anthropometrically and socio-demographically to the entire screening population and to micro-census data , a representative national survey .


The screening process assessed @ candidates for eligibility .


Paediatricians reported having suggested programme participation to @ candidates ( referred to as @ % ) .


@ candidates ( @ % ) returned a written consent for programme participation .


@ candidates ( @ % ) started the intervention .


The study population ( n = @ ) included more obese ( @ % vs. @ % ; p < @ ) and fewer overweight participants ( @ % vs. @ % ; p < @ ) than the entire screening population .


Compared to the micro-census , families with adolescents ( @ % vs. @ % ; p < @ ) and single parents ( @ % vs. @ % ; p < @ ) were underrepresented in the study population , whereas families living in rural areas were overrepresented ( @ % vs. @ % ; p < @ ) .


Although @ % of the paediatricians forwarded the suggestion for programme participation to eligible families , participation rates for this low-threshold ; telephone-based obesity intervention remained very low .


`` Hard-to-engage groups '' for effective obesity prevention seem to include single parents , as well as parents of adolescents .


To examine the cardiopulmonary effects of infusions of remifentanil or morphine , and their influence on recovery of horses anesthetized with isoflurane and dexmedetomidine .


Randomized crossover study with @-day rest periods .


Six adult horses ( @ @ kg ) .


After the horses were sedated with xylazine , anaesthesia was induced with ketamine and diazepam , and maintained with isoflurane .


After approximately @ minutes , a dexmedetomidine infusion was started ( @ g kg ( -@ ) then @ g ( -@ ) kg ( -@ ) hour ( -@ ) ) in combination with either saline ( group S ) , morphine ( @ mg kg ( -@ ) then @ mg kg ( -@ ) hour ( -@ ) ; group M ) , or remifentanil ( @ g kg ( -@ ) hour ( -@ ) ; group R ) for @ minutes .


Mean arterial pressure , heart rate , end-tidal carbon dioxide tension , and end-tidal isoflurane concentration were recorded every @ minutes .


Core body temperature , cardiac output , right ventricular and arterial blood-gas values were measured every @ minutes .


Cardiac index , systemic vascular resistance ( SVR ) , intrapulmonary shunt fraction , alveolar dead space , oxygen delivery and extraction ratio were calculated .


Recoveries were videotaped and scored by two observers blinded to the treatment .


Data were analyzed using repeated measures anova followed by Dunnett 's or Bonferroni 's significant difference test .


Recovery scores were analyzed using a Kruskal-Wallis test .


No significant differences were found among groups .


Compared to baseline , heart rate decreased and SVR increased significantly in all groups , and cardiac index significantly decreased in groups S and M. Hemoglobin concentration , oxygen content and oxygen delivery significantly decreased in all groups .


The oxygen extraction ratio significantly increased in groups M and R. Lactate concentration significantly increased in group S. Recovery scores were similar among groups .


Dexmedetomidine alone or in combination with remifentanil or morphine infusions was infused for @ minutes without adverse effects in the @ healthy isoflurane-anesthetized horses in this study .


It is well established through randomized trials that oral antibiotics given with or without a mechanical bowel preparation ( MBP ) prior to colorectal procedures reduce complications , while MBP given alone provides no benefit .


We aimed to characterize trends surrounding bowel preparation in children and determine whether contemporary practice is evidence-based .


Retrospective analysis of patients undergoing colorectal procedures at @ children 's hospitals ( @/@/@ -@ / @/@ ) was performed .


Patients were analyzed for diagnosis , pre-admission status , and inpatient bowel preparation .


Bowel preparation was considered evidence-based if oral antibiotics were utilized with or without a MBP .


@ % of all patients were pre-admitted ( n = @,@ ) , and the most common diagnoses were anorectal malformations ( @ % ) , inflammatory bowel disease ( @ % ) , and Hirschsprung 's Disease ( @ % ) .


The most common preparation approaches were MBP alone ( @ % ) , MBP + oral antibiotics ( @ % ) , and oral antibiotics alone ( @ % ) , although significant variation was found in hospital-specific rates for each approach ( MBP alone : @-@ @ % , MBP + oral antibiotics : @-@ @ % , orals alone : @-@ @ % , p < @ ) .


Only @ % of all patients received an evidence-based preparation ( range by hospital : @-@ @ % , p < @ ) , and this rate decreased significantly during the five-year study period ( @ % in @ vs. @ % in @ , p < @ ) .


According to the best available clinical evidence , less than a quarter of all children pre-admitted for elective colorectal procedures receive a bowel preparation proven to reduce infectious complications .


To assess the effects of short-term resistance training and pulsed electromagnetic fields on bone metabolism and joint function in patients with haemophilia with osteoporosis .


A randomized , controlled , patient and blood sample assessor-blinded , six-week trial , three times weekly .


Hospital outpatients with severe haemophilia A and osteoporosis .


Forty-eight patients were randomly assigned to resistance training ( RT , n = @ ) , combined resistance training with pulsed electromagnetic fields ( RTPEMF , n = @ ) , pulsed electromagnetic fields ( PEMF , n = @ ) and control ( n = @ ) groups .


The RT group received @-@ minutes of resistance exercises and placebo pulsed electromagnetic fields .


The RTPEMF group received the same exercises with lower repetition and @ minutes of pulsed electromagnetic fields .


The PEMF group was exposed to @ minutes of pulsed electromagnetic fields ( @ Hz and @ Gauss ) .


Bone-specific alkaline phosphatase , N-terminal telopeptide of type @ collagen , and joint function , using the modified Colorado Questionnaire , were measured before and after the programme .


The absolute change of bone-specific alkaline phosphatase was significant in the RT and RTPEMF groups compared with the control group ( @ @ , @ @ , and -@ @ U/L , respectively ) .


The absolute changes in the total score for joint function were significant for knees , ankles , and elbows in the RT group ( @ @ , @ @ , and @ @ , respectively ) and the RTPEMF group ( @ @ , @ @ , and @ @ , respectively ) compared to the PEMF and control groups .


This value was significant for knee joints in the PEMF group compared to the control group ( @ @ and @ @ , respectively ) .


Resistance training is effective for improving bone formation and joint function in severe haemophilia A patients with osteoporosis .


This study compares the long-term results of pneumatic dilatations versus laparoscopic myotomy using treatment failure as the primary outcome .


The frequency and degree of dysphagia , the effects on quality of life ( QoL ) , and health economy were also examined .


Fifty-three patients with achalasia were randomized to laparoscopic myotomy with a posterior partial fundoplication -LSB- laparoscopic myotomy ( LM ) n = @ -RSB- or repetitive pneumatic dilatation -LSB- pneumatic dilatation ( PD ) n = @ -RSB- .


The median observation period was @ months ( range @-@ ) .


At the minimal follow-up of @ years , ten patients ( @ % ) in the dilatation group and two patients ( @ % ) in the myotomy group , including two patients lost to follow-up ( one in each arm ) , were classified as failures ( p = @ ) .


The cumulative incidence of treatment failures was analyzed by survival statistics .


Taking the entire follow-up period into account , a significant difference was observed in favor of the LM strategy ( p = @ ) .


Although both treatments resulted in significant improvements in dysphagia scores , LM was significantly favored over PD after @ and @ years , but not after @ years .


Health-related QoL assessed by the personal general well being score was higher in the LM group after @ years , but the difference was not fully statistically significant at @ years .


Direct medical costs during the entire follow-up period were in median $ @,@ for LM as compared to $ @,@ for PD ( p = @ ) .


This long-term follow-up of a randomized clinical study shows that LM is superior to repetitive PD treatment of newly diagnosed achalasia , albeit that this surgical strategy is burdened by high initial direct medical costs .


www.ClinicalTrials.gov NCT @ .


Individual barriers to weight loss and physical activity goals in the Diabetes Prevention Program , a randomized trial with @ years average treatment duration , have not been previously reported .


Evaluating barriers and the lifestyle coaching approaches used to improve adherence in a large , diverse participant cohort can inform dissemination efforts .


Lifestyle coaches documented barriers and approaches after each session ( mean session attendance = @ ) .


Subjects were @ intensive lifestyle participants ( mean age = @ years ; mean BMI = @ kg/m ; @ % female , @ % non-Caucasian ) .


Barriers and approaches used to improve adherence were ranked by the percentage of the cohort for whom they applied .


Barrier groupings were also analyzed in relation to baseline demographic characteristics .


Top weight loss barriers reported were problems with self-monitoring ( @ % ) ; social cues ( @ % ) ; holidays ( @ % ) ; low activity ( @ % ) ; and internal cues ( thought/mood ) ( @ % ) .


Top activity barriers were holidays ( @ % ) ; time management ( @ % ) ; internal cues ( @ % ) ; illness ( @ % ) , and motivation ( @ % ) .


The percentage of the cohort having any type of barrier increased over the long-term intervention period .


A majority of the weight loss barriers were significantly associated with younger age , greater obesity , and non-Caucasian race/ethnicity ( p-values vary ) .


Physical activity barriers , particularly thought and mood cues , social cues and time management , physical injury or illness and access/weather , were most significantly associated with being female and obese ( p < @ for all ) .


Lifestyle coaches used problem-solving with most participants ( @ % short-term ; > @ % long term ) and regularly reviewed self-monitoring skills .


More costly approaches were used infrequently during the first @ sessions ( @ % ) but increased over @ years .


Behavioral problem solving approaches have short and long term dissemination potential for many kinds of participant barriers .


Given minimal resources , increased attention to training lifestyle coaches in the consistent use of these approaches appears warranted .


Lack of universal , annual testing for human immunodeficiency virus ( HIV ) in health facilities suggests that expansion of HIV testing and counselling ( HTC ) to non-clinical settings is critical to the achievement of national goals for prevention , care and treatment .


Consideration should be given to the ability of lay counsellors to perform home-based HTC in community settings .


We implemented a community cluster randomized controlled trial of home-based HTC in Sisonke District , South Africa .


Trained lay counsellors conducted door-to-door HIV testing using the same rapid tests used by the local health department at the time of the study ( SD Bioline and Sensa ) .


To monitor testing quality and counsellor skill , additional dry blood spots were taken and sent for laboratory-based enzyme-linked immunosorbent assay ( ELISA ) testing .


Sensitivity and specificity were calculated using the laboratory result as the gold standard .


From @ samples , the counsellor and laboratory results matched in all but @ cases .


In @ cases , the counsellor judged the result as indeterminate , whereas the laboratory judged @ positive , eight negative and three indeterminate , indicating that the counsellor may have erred on the side of caution .


Sensitivity was @ % ( @ % CI : @-@ @ % ) , and specificity @ % ( @ % CI : @-@ @ % ) , for the lay counsellor field-based rapid tests .


Both measures are high , and the lower confidence bound for specificity meets the international standard for assessing HIV rapid tests .


These findings indicate that adequately trained lay counsellors are capable of safely conducting high-quality rapid HIV tests and interpreting the results as per the kit guidelines .


These findings are important given the likely expansion of community and home-based testing models and the shortage of clinically trained professional staff .


Comparison of a multimodal intervention WE CALL ( study initiated phone support/information provision ) versus a passive intervention YOU CALL ( participant can contact a resource person ) in individuals with first mild stroke .


This study is a single-blinded randomized clinical trial .


Primary outcome includes unplanned use of health services ( participant diaries ) for adverse events and quality of life ( Euroquol-@D , Quality of Life Index ) .


Secondary outcomes include planned use of health services ( diaries ) , mood ( Beck Depression Inventory II ) , and participation ( Assessment of Life Habits -LSB- LIFE-H -RSB- ) .


Blind assessments were done at baseline , @ , and @ months .


A mixed model approach for statistical analysis on an intention-to-treat basis was used where the group factor was intervention type and occasion factor time , with a significance level of @ .


We enrolled @ patients ( WE = @ ; YOU = @ ) with a mean age of @ @ years , and @ % were women .


No significant differences were seen between groups at @ months for any outcomes with both groups improving from baseline on all measures ( effect sizes ranged from @ to @ ) .


The only significant change for both groups from @ months to @ year ( n = @ ) was in the social domains of the LIFE-H ( increment in score , @ / @ @ -LSB- @ % confidence interval , @-@ @ -RSB- ; effect size , @ ) .


Qualitatively , the WE CALL intervention was perceived as reassuring , increased insight , and problem solving while decreasing anxiety .


Only @ of @ ( @ % ) YOU CALL participants availed themselves of the intervention .


Although the @ groups improved equally over time , WE CALL intervention was perceived as helpful , whereas YOU CALL intervention was not used .


The consumption of citrus fruits is associated with health benefits .


However , clinical data regarding the effects of grapefruit flavanone consumption on vascular function are lacking .


The objective of the present study was to address the role of flavanones in the long-term effects induced by grapefruit juice ( GFJ ) consumption on vascular function in healthy postmenopausal women .


Forty-eight healthy postmenopausal women aged @-@ y within @-@ y since menopause , a body mass index ( in kg/m ( @ ) ) of @-@ , and a waist size > @ cm completed this double-blind , randomized , controlled , crossover trial .


These volunteers were randomly assigned to consume @ mL GFJ/d , providing @ mg naringenin glycosides , or a matched control drink without flavanones for @ mo each , with a @-mo washout between beverages .


The primary endpoint was the assessment of endothelial function in the brachial artery by using flow-mediated dilation .


Blood pressure , arterial stiffness , and endothelial function in the peripheral arterial bed were also evaluated as indicators of vascular function .


These measurements and blood collection for clinical biochemical markers were performed in overnight-fasted subjects before and after the @-mo treatment periods .


The mean SD carotid-femoral pulse wave velocity , which reflects central aortic stiffness , was statistically significantly lower after consumption of GFJ ( @ @ m/s ) than after consumption of the matched control drink without flavanones ( @ @ m/s ) , with a P value of @ for the treatment effect .


Endothelial function in macro - and microcirculation , blood pressure , anthropometric measures , glucose metabolism , and biomarkers of inflammation and oxidative stress were not affected by the intervention .


Regular GFJ consumption by middle-aged , healthy postmenopausal women is beneficial for arterial stiffness .


This effect may be related to flavanones present in grapefruit .


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


Compare public perceptions and intentions to undergo colorectal cancer screening tests following detailed information regarding CT colonography ( CTC ; after non-laxative preparation or full-laxative preparation ) , optical colonoscopy ( OC ) or flexible sigmoidoscopy ( FS ) .


A total of @,@ invitees approaching screening age ( @-@ years ) were randomly allocated to receive detailed information on a single test and asked to return a questionnaire .


Outcomes included perceptions of preparation and test tolerability , health benefits , sensitivity and specificity , and intention to undergo the test .


Six hundred three invitees responded with valid questionnaire data .


Non-laxative preparation was rated more positively than enema or full-laxative preparations -LSB- effect size ( r ) = @ to @ ; p < @ to @ -RSB- ; both forms of CTC and FS were rated more positively than OC in terms of test experience ( r = @ to @ ; all p-values < @ ) .


Perceptions of health benefits , sensitivity and specificity ( p = @ to @ ) , and intention to undergo the test ( p = @ ) did not differ between tests ( n = @-@ for each test ) .


Despite non-laxative CTC being rated more favourably , this study did not find evidence that offering it would lead to substantially higher uptake than full-laxative CTC or other methods .


However , this study was limited by a lower than anticipated response rate .


Improving uptake of colorectal cancer screening tests could improve health benefits Potential invitees rate CTC and flexible sigmoidoscopy more positively than colonoscopy Non-laxative bowel preparation is rated better than enema or full-laxative preparations These positive perceptions alone may not be sufficient to improve uptake Health benefits and accuracy are rated similarly for preventative screening tests .


To describe the incidence and outcomes of reoperations for glaucoma in the Tube Versus Trabeculectomy ( TVT ) Study .


Cohort study of patients in a multicenter randomized clinical trial .


The TVT Study enrolled @ patients with medically uncontrolled glaucoma who had previous cataract and/or glaucoma surgery .


Randomization assigned @ patients to surgery with a tube shunt ( @ mm ( @ ) Baerveldt glaucoma implant ) and @ patients to trabeculectomy with mitomycin C ( @ mg/mL for @ minutes ) .


Data were analyzed from patients who failed their assigned treatment and had additional glaucoma surgery .


Outcome measures included intraocular pressure ( IOP ) , use of glaucoma medications , visual acuity , surgical complications , and failure ( IOP > @ mm Hg or not reduced by @ % , IOP @ mm Hg , additional glaucoma surgery , or loss of light perception vision ) .


Additional glaucoma surgery was performed in @ patients in the tube group and @ patients in the trabeculectomy group in the TVT Study , and the @-year cumulative reoperation rate was @ % in the tube group and @ % in the trabeculectomy group ( P = @ ) .


Follow-up ( mean SD ) after additional glaucoma surgery was @ @ months in the tube group and @ @ months in the trabeculectomy group ( P = @ ) .


At @ years after a glaucoma reoperation , IOP ( mean SD ) was @ @ mm Hg in the tube group and @ @ mm Hg in the trabeculectomy group ( P = @ ) .


The number of glaucoma medications ( mean SD ) after @ years of follow-up was @ @ in the tube group and @ @ in the trabeculectomy group ( P = @ ) .


The cumulative probability of failure at @ , @ , @ , and @ years after additional glaucoma surgery was @ % , @ % , @ % , and @ % , respectively , in the tube group , and @ % , @ % , @ % , and @ % in the trabeculectomy group ( P = @ ) .


Reoperations to manage complications were required in @ patient in the tube group and @ patients in the trabeculectomy group ( P = @ ) .


The rate of reoperation for glaucoma was higher following trabeculectomy with mitomycin C than tube shunt surgery in the TVT Study .


Similar surgical outcomes were observed after additional glaucoma surgery , irrespective of initial randomized treatment in the study .


Blockade of platelet activation and aggregation can inhibit metastasis in preclinical models and is associated with cancer prevention .


To test whether disruption of platelet function with clopidogrel and aspirin would decrease the number of circulating tumor cells ( CTCs ) in patients with metastatic breast cancer , a randomized phase II study was performed .


Patients with metastatic breast cancer who were not currently receiving cytotoxic chemotherapy were eligible .


Patients were randomized to receive either clopidogrel and aspirin or to a control group receiving no treatment .


Phlebotomy was performed at baseline , at @ and @ weeks , and monthly thereafter to obtain specimens to assess CTC , platelet aggregation , and thrombin activity .


The primary end point was the proportion of patients with detectable CTCs at @ month .


Forty-eight patients were enrolled and @ were evaluable at @month .


Baseline CTC numbers were @ in @ % and @ in @ % of patients .


Despite adequate platelet function inhibition in the treatment group , the proportion of patients with detectable CTCs was similar between the clopidogrel/aspirin and control groups at baseline ( P = @ ) and @ weeks ( P = @ ) , showing no treatment effect .


Measured endogenous thrombin potential did not correlate with CTC number .


No bleeding-related serious adverse events ( SAEs ) occurred .


The baseline CTC numbers were lower than expected , decreasing the ability to detect an impact of platelet inhibition on CTCs .


Clopidogrel and aspirin were well tolerated .


Future studies evaluating the potential therapeutic role of antiplatelet therapy in breast cancer remain of interest , and they may be informed by theseresults .


The Carotid Revascularization Endarterectomy Versus Stenting Trial was completed with a low stroke and death rate .


A lead-in series of patients receiving carotid artery stenting was used to select the physician-operators for the study , where performance was evaluated by complication rates and by peer review of cases .


Herein , we assess the potential contribution of statistical evaluation of complication rates .


The ability to discriminate between stent operators who can successfully meet the published guideline of < @ % combined rate of stroke and death is calculated under the binomial distribution , based on a small consecutive case series ( n = @ patients ) .


A criterion of @ stroke or death events among the @ patients ( < @ % event rate ) was required of operators .


Setting such a high criterion , however , ensures an inability to exclude operators who can not meet the criteria .


In fact , if a good operator is defined as having a @ % event rate and a poor operator as a @ % event rate , even a series of @ patients would ( on average ) still exclude @ % of the good operators and include @ % of the poor operators .


The low periprocedural event rates in the trial suggest success in separating skillful operators from less skillful .


However , it seems unlikely that statistical assessment of event rates in the lead-in contributed to successful selection , but rather successful selection was more likely because of peer review of subjective and other factors including patient volume and technical approaches .


The objective of the study was to compare long-term results of subtotal vs total abdominal hysterectomy for benign uterine diseases @ years after hysterectomy , with urinary incontinence as the primary outcome measure .


This was a long-term follow-up of a multicenter , randomized clinical trial without blinding .


Eleven gynecological departments in Denmark contributed participants to the trial .


Women referred for benign uterine diseases who did not have contraindications to subtotal abdominal hysterectomy were randomized to subtotal ( n = @ ) vs total ( n = @ ) abdominal hysterectomy .


All women enrolled in the trial from @ to @ who were still alive and living in Denmark ( n = @ ) were invited to answer the validated questionnaire used in prior @ and @ year follow-ups .


Hospital contacts possibly related to hysterectomy from @ to @ years postoperatively were registered from discharge summaries from all public hospitals in Denmark .


The results were analyzed as intention to treat and per protocol .


Possible bias caused by missing data was handled by multiple imputation .


The primary outcome was urinary incontinence ; the secondary outcomes were pelvic organ prolapse , constipation , pain , sexuality , quality of life ( Short Form-@ questionnaire ) , hospital contacts , and vaginal bleeding .


The questionnaire was answered by @ of @ women ( @ % ) ( subtotal hysterectomy -LSB- n = @ -RSB- -LSB- @ % -RSB- ; total hysterectomy -LSB- n = @ -RSB- -LSB- @ % -RSB- ) .


Mean follow-up time was @ years and mean age at follow-up was @ years .


After subtotal abdominal hysterectomy , @ of @ women ( @ % ) complained of urinary incontinence compared with @ of @ women ( @ % ) after total abdominal hysterectomy @ years after hysterectomy ( relative risk , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


After a multiple imputation analysis , this difference disappeared ( relative risk , @ ; @ % confidence interval , @-@ @ ; P = @ ) .


No differences were seen in any of the secondary outcomes .


Subtotal abdominal hysterectomy was not superior to total abdominal hysterectomy on any outcomes .


More women seem to have subjective urinary incontinence @ years after subtotal abdominal hysterectomy .


This result was not confirmed by multiple imputation analysis and should be interpreted cautiously .


Enterococci , the second leading cause of health care-associated infections , have evolved from commensal and harmless organisms to multidrug-resistant bacteria associated with a significant increase in patient morbidity and mortality .


Prevention of ongoing spread of this organism within and between hospitals is important .


In this study , we characterized Enterococcus transmission dynamics for bacterial reservoirs commonly encountered by anesthesia providers during the routine administration of general anesthesia .


Enterococcus isolates previously obtained from bacterial reservoirs frequently encountered by anesthesiologists ( patient nasopharynx and axilla , anesthesia provider hands , and the adjustable pressure-limiting valve and agent dial of the anesthesia machine ) at @ major academic medical centers were identified as possible intraoperative bacterial transmission events by class of pathogen , temporal association , and phenotypic analysis ( analytical profile indexing ) .


They were then subjected to antibiotic disk diffusion sensitivity for transmission event confirmation .


Isolates involved in confirmed transmission events were further analyzed to characterize the frequency , mode , origin , location of transmission events , and antibiotic susceptibility of transmitted pathogens .


Three hundred eighty-nine anesthesia reservoir isolates were previously identified by gross morphology and simple rapid tests as Enterococcus .


The combination of further analytical profile indexing analysis and temporal association implicated @ % ( @/@ ) of those isolates in possible intraoperative bacterial transmission events .


Approximately , @ % ( @/@ ) of possible transmission events were confirmed by additional antibiotic disk diffusion analysis .


Two phenotypes , E@ and E@ , explained @ % ( @/@ ) of confirmed transmission events .


For both phenotypes , provider hands were a common reservoir of origin proximal to the transmission event ( @ % -LSB- @/@ -RSB- hand origin for E@ and @ % -LSB- @/@ -RSB- hand origin for E@ ) and site of transmission ( @ % -LSB- @/@ -RSB- hand transmission location for E@ and @ % -LSB- @/@ -RSB- hand transmission location for E@ ) .


Anesthesia provider hand contamination is a common proximal source and transmission location for Enterococcus transmission events in the anesthesia work area .


Future work should evaluate the impact of intraoperative hand hygiene improvement strategies on the dynamics of intraoperative Enterococcus transmission .


To describe quantitative and qualitative features of eyes with advanced bullous keratopathy assessed using ultrasound biomicroscopy , before and after anterior stromal puncture ( ASP ) or amniotic membrane transplantation ( AMT ) procedures to relieve chronic pain .


The present descriptive comparative study included @ eyes of @ patients with chronic intermittent pain due to bullous keratopathy who were randomly assigned to one of the two treatments ( AMT or ASP ) .


Ultrasound biomicroscopy ( Humphrey , UBM @ , @ MHz transducer , immersion technique ) was used , and a questionnaire about pain intensity was completed preoperatively and postoperatively at days @ and @ , respectively .


Exclusion criteria were age < @ years , presence of concurrent infection , ocular hypertension , and absence of pain .


In a @-day follow-up , the AMT group exhibited mean central corneal thickness ( CCT ) , @ m preoperatively and @ m postoperatively ( p < @ ) ; mean epithelial thickness ( ET ) , @ m preoperatively and @ m postoperatively ( p < @ ) ; and mean stromal thickness ( ST ) , @ m preoperatively and @ m postoperatively ( p = @ ) .


The ASP group exhibited mean CCT , @ m preoperatively and @ m postoperatively ( p < @ ) ; mean ET , @ m preoperatively and @ m postoperatively ( p < @ ) ; and mean ST , @ m preoperatively and @ m postoperatively ( p < @ ) .


Correlations between CCT and pain intensity in the AMT group ( p = @ pre - and postoperatively ) and the ASP group ( p = @ preoperatively and p = @ at the @-day follow-up ) were not statistically significant .


Epithelial and stromal edema , Descemet 's membrane folds , epithelial bullae , and the presence of interface fluid were frequently observed qualitative features .


CCT increased over time in both groups .


The magnitude of CCT did not correlate with pain intensity in the sample studied .


The presence of interface fluid was a qualitative feature specifically found in some patients who underwent AMT .


The association between low birthweight ( LBW ) and risk of developing type @ diabetes may involve epigenetic mechanisms , with skeletal muscle being a prime target tissue .


Differential DNA methylation patterns have been observed in single genes in muscle tissue from type @ diabetic and LBW individuals , and we recently showed multiple DNA methylation changes during short-term high-fat overfeeding in muscle of healthy people .


In a randomised crossover study , we analysed genome-wide DNA promoter methylation in skeletal muscle of @ young LBW men and @ matched normal birthweight ( NBW ) men after a control and a @ day high-fat overfeeding diet .


DNA methylation was measured using Illumina 's Infinium BeadArray covering @,@ CpG sites representing @,@ different genes .


After correction for multiple comparisons , DNA methylation levels were found to be similar in the LBW and NBW groups during the control diet .


Whereas widespread DNA methylation changes were observed in the NBW group in response to high-fat overfeeding , only a few methylation changes were seen in the LBW group ( ( @ ) , p < @ ) .


Our results indicate lower DNA methylation plasticity in skeletal muscle from LBW vs NBW men , potentially contributing to understanding the link between LBW and increased risk of type @ diabetes .


To investigate the efficacy and safety of ulipristal acetate ( UPA ) for long-term treatment of symptomatic uterine fibroids .


Repeated intermittent open-label UPA courses , each followed by randomized double-blind norethisterone acetate ( NETA ) or placebo .


European clinical gynecology centers .


Two hundred and nine women with symptomatic fibroids including heavy menstrual bleeding .


Patients received up to four @-month courses of UPA @ mg daily , immediately followed by @-day double-blind treatment with NETA ( @ mg daily ) or placebo .


Amenorrhea , fibroid volume , endometrial histology .


After the first UPA course , amenorrhea occurred in @ % of women , with median onset ( from treatment start ) of @ days ( interquartile range , @-@ days ) .


Median fibroid volume change was -@ % ( interquartile range , -@ % ; -@ % ) .


Amenorrhea rates were @ % , @ % , and @ % for the @ , @ , and @ women who received treatment courses @ , @ , and @ , respectively .


Median times to amenorrhea were @ , @ , and @ days for treatment courses @ , @ , and @ , respectively .


Median fibroid volume changes from baseline were -@ % , -@ % , and -@ % after treatment courses @ , @ , and @ , respectively .


All endometrial biopsies showed benign histology without hyperplasia ; NETA did not affect fibroid volume or endometrial histology .


Repeated @-month UPA courses effectively control bleeding and shrink fibroids in patients with symptomatic fibroids .


To evaluate the prevalence of metabolic syndrome ( MetS ) and its association with physical capacity , disability , and self-rated health in older adults at high risk of mobility disability , including those with and without diabetes mellitus .


Cross-sectional analysis .


Lifestyle Interventions and Independence for Elders ( LIFE ) Study .


Community-dwelling sedentary adults aged @ to @ at high risk of mobility disability ( Short Physical Performance Battery ( SPPB ) score @ ; mean @ @ ) ( N = @,@ ) .


Metabolic syndrome was defined according to the @ multiagency harmonized criteria ; outcomes were physical capacity ( @-m walk time , grip strength , SPPB score ) , disability ( composite @-item score ) , and self-rated health ( @-point scale ranging from excellent to poor ) .


The prevalence of MetS was @ % in the overall sample ( @ % of those with diabetes mellitus , @ % of those without ) .


MetS was associated with stronger grip strength ( mean difference ( ) = @ kg , P = @ ) in the overall sample and in participants without diabetes mellitus and with poorer self-rated health ( = @ kg , P < @ ) in the overall sample only .


No significant differences were found in @-m walk time , SPPB score , or disability score between participants with and without MetS , in the overall sample or diabetes mellitus subgroups .


Metabolic dysfunction is highly prevalent in older adults at risk of mobility disability , yet consistent associations were not observed between MetS and walking speed , lower extremity function , or self-reported disability after adjusting for known and potential confounders .


Longitudinal studies are needed to investigate whether MetS accelerates declines in functional status in high-risk older adults and to inform clinical and public health interventions aimed at preventing or delaying disability in this group .


To verify the clinical efficacy on chronic fatigue syndrome of qi deficiency syndrome treated with acupuncture at selective time and explore the effect mechanism .


Eighty patients were randomized into a selective-time-acupuncture group and an acupuncture group , @ cases in each one .


Qihai ( CV @ ) , Guanyuan ( CV @ ) , Hegu ( LI @ ) , Taichong ( LR @ ) , Sanyinjiao ( SP @ ) and Zusanli ( ST @ ) were selected in the two groups .


In the selective-time-acupuncture group , acupuncture was used at @:@ am to @:@ am .


In the acupuncture group , acupuncture was used at any time except in the range from @:@ am to @:@ am .


No any manipulation was applied after the arrival of needling sensation .


The treatment was given once every day , @ day treatment made one session and two sessions of treatment were required .


The fatigue scale was adopted to evaluate the efficacy before and after treatment in the patients of the two groups .


The ratios among CD@ + , CD@ + and CD@ + T cells in the peripheral blood were detected before ad b a after treatment .


In the acupuncture group , the total score of fatigue and the score of physical fatigue were reduced after treatment as compared with those before treatment ( all P < @ ) .


In the selective-time - acupuncture group , the total score of fatigue , the s core of physical fatigue and the score of mental fatigue after treatment were reduced obviously as compared with those hefore treatment ( all P < @ ) .


The improvements in the scores of the selective-time-acupuncture group were superior to the acupuncture group ( all P < @ ) .


The ratio of CD@ + and CD@ + T cells was increased obviously after treatment in the two groups ( all P < @ ) and the ratio of CD@ + and CD@ + T cells was reduced obviously in the selective-time-acupuncture group ( P < @ ) , which was better than that in the acupuncture group ( all P < @ ) .


The total effective rate was @ % ( @/@ ) in the selective-time-acupuncture group , which was better than @ % ( @/@ ) in the acupuncture group ( P < @ ) .


The acupuncture therapy at selective time is effective in the treatment of chronic fatigue syndrome of qi deficiency syndrome , which is especially better at relieving mental fatigue .


The effect of this therapy is achieved probably by improving the immune function via the regulation of the ratios among CD@ + , CD@ + and CD@ + T cells .


To understand whether using oral contraceptive pills ( OCPs ) results in temporary interruption of bleeding for etonogestrel contraceptive implant users during a @-day course .


In this double-blind trial , we randomly assigned etonogestrel implant users reporting @ consecutive days or more of bothersome bleeding to receive @ pills of study drug ( @ microgram levonorgestrel and @ microgram ethinyl estradiol combined OCPs ) or an identical-appearing placebo .


The primary outcome was the proportion of women in each group who stopped bleeding during therapy and continued to report no bleeding at the end of therapy .


Prespecified secondary outcomes were number of days until temporary interruption of bleeding occurred , number of days without bleeding during therapy , and number of days to recurrence of bleeding after discontinuation of therapy .


We hypothesized that temporary interruption of bleeding would occur in @ % of the treatment group compared with @ % in the control group ; using @ % power , we needed a sample size of @ women .


We performed intent-to-treat analysis .


From November @ through December @ , @ women were screened and @ were randomized : OCPs ( n = @ ) or placebo ( n = @ ) .


The majority was young , Caucasian women with reported bleeding as extremely or very annoying ; groups had similar baseline characteristics .


Participants randomized OCPs were more likely ( @ of @ -LSB- @ % @ % -RSB- compared with six of @ -LSB- @ % @ % -RSB- ) to have a temporary interruption of bleeding during the study drug period ( odds ratio @ , @ % confidence interval @-@ @ ) .


Of women in the OCP arm who had a temporary interruption , @ % had bleeding recurrence within @ days after treatment .


Bothersome bleeding in etonogestrel contraceptive implant users will usually stop with @-day OCP treatment , but bleeding most often resumes within days of treatment cessation .


Examine longitudinal associations between sources of social support and social undermining for healthy eating and physical activity and weight change .


Data are from @ employed adults participating in a cluster-randomized multilevel weight gain prevention intervention .


Primary predictors included social support and social undermining for two types of behaviors ( healthy eating and physical activity ) from three sources ( family , friends , and coworkers ) obtained via self-administered surveys .


The primary outcome ( weight in kg ) was measured by trained staff .


Data were collected at baseline , @ months , and @ months .


Linear multivariable models examined the association of support and social undermining with weight over time , adjusting for intervention status , time , gender , age , education , and clustering of individuals within schools .


Adjusting for all primary predictors and covariates , friend support for healthy eating ( = -@ ) , coworker support for healthy eating ( = -@ ) , and family support for physical activity ( = -@ ) were associated with weight reduction at @ months ( P-values < @ ) .


Family social undermining for healthy eating was associated with weight gain at @ months ( = @ ; P = @ ) .


Among adult employees , friend and coworker support for healthy eating and family support for physical activity predicted improved weight management .


Interventions that help adults navigate family social undermining of healthy eating are warranted .


We assessed the impact of hot flashes and various forms of hormone therapy on health-related quality of life and sexual well-being in recently postmenopausal women .


We prospectively interviewed @ healthy women about hot flashes and health-related quality of life ( using the Women 's Health Questionnaire and the McCoy Female Sexuality Questionnaire ) , menopause-related symptoms , and general health .


The women were classified into those with ( n = @ ) and without ( n = @ ) hot flashes and treated for @ months with transdermal estradiol ( @ mg/d ) , oral estradiol ( @ mg/d ) with or without medroxyprogesterone acetate ( @ mg/d ) , or placebo .


At baseline , hot flashes contributed most strongly to poor sleep ( correlation coefficient r = -@ , P < @ ) , somatic symptoms such as muscle pains ( r = -@ , P < @ ) , menstrual cycle-resembling complaints ( r = -@ , P < @ ) , anxiety and fears ( r = -@ , P < @ ) , decreased memory and concentration ( r = -@ , P = @ ) , and sexual behavior ( r = -@ , P = @ ) .


The different hormone therapy regimens alleviated hot flashes equally effectively and were therefore combined into a single group for further analysis .


In women with baseline flashes , hormone therapy use significantly improved the scores for sleep ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- , hormone therapy vs placebo , P = @ , at @ mo ) , memory and concentration capacity ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- , P < @ , at @ mo ) , and anxiety and fears ( @ -LSB- @ -RSB- vs @ -LSB- @ -RSB- , P = @ , at @ mo ) .


Hormone therapy use showed no significant impact on these variables in women without baseline flashes .


Hot flashes contribute differently to various variables affecting health-related quality of life shortly after menopause .


Estradiol or an estradiol-medroxyprogesterone acetate combination similarly alleviates hot flashes and improves health-related quality of life in relation to elimination of hot flashes .


Hormone therapy use does not confer any detectable quality-of-life benefit over placebo in women without disturbing baseline flashes .


A restricted sympathetic block during spinal anesthesia may minimize hemodynamic changes .


This prospective randomized study compared unilateral and bilateral spinal anesthesia with respect to the intra - and postoperative advantages and complications of each technique .


Spinal anesthesia was induced with @ % hyperbaric bupivacaine and a @-G Quincke needle ( Dr. J ) in two groups of patients with physical status ASA I-II who had been admitted for orthopedic surgeries .


In group A , dural puncture was performed with the patient in a seated position using @ cm ( @ ) of hyperbaric bupivacaine .


Each patient was then placed in the supine position .


In group B , dural puncture was performed with the patient in the lateral decubitus position with @ cm ( @ ) of hyperbaric bupivacaine .


The lower limb was the target limb .


The speed of injection was @ mL/@s , and the duration of time spent in the lateral decubitus position was @ min .


The demographic data were similar in both groups .


The time to the onset of the sensory and motor block was significantly shorter in group A ( p = @ ) .


The duration of motor and sensory block was shorter in group B ( p < @ ) .


The success rate for unilateral spinal anesthesia in group B was @ % .


In two patients , the spinal block spread to the non-dependent side .


The incidence of complications ( nausea , headache , and hypotension ) was lower in group B ( p = @ ) .


When unilateral spinal anesthesia was performed using a low-dose , low-volume and low-flow injection technique , it provides adequate sensory-motor block and helps to achieve stable hemodynamic parameters during orthopedic surgery on a lower limb .


Patients were more satisfied with this technique as opposed to the conventional approach .


Furthermore , this technique avoids unnecessary paralysis on the non-operated side .


This study aimed to establish the noninferiority of a single-freeze application with CO@ or N@O compared with the standard double freeze with N@O for cryotherapy treatment .


Sixty women undergoing hysterectomy for reasons other than cervical cancer or precancer were randomized to @ of @ techniques as follows : ( @ ) double freeze with N@O , ( @ ) single freeze with N@O , or ( @ ) single freeze with CO@ .


The cervix was separated and cut into anterior and posterior segments , and the deepest area of necrosis was recorded .


Comparisons were made using regression analysis .


The margin of noninferiority was defined as @ mm .


On the anterior lip , a single freeze with N@O was noninferior to a double freeze of the same gas , but on the posterior lip , the single freeze was not .


The single freeze of CO@ did not provide sufficient depth of necrosis in either lip to infer noninferiority versus the double freeze with N@O .


A single freeze with N@O is noninferior to a double-freeze technique in the anterior but not the posterior lip .


However , the result for posterior lips was close to reaching statistical significance .


In addition , CO@ had approximately @ mm shallower depth of necrosis compared with N@O techniques ; however , the clinical implications are unknown .


Given the extensive use of CO@ globally , further clinical evaluation is needed .


Vitamin D repletion with high doses of vitamin D is often recommended to patients and healthy subjects .


The safety , especially concerning changes in urinary calcium excretion is of great importance .


In a double-blinded , placebo-controlled study in @ healthy volunteers , we examined the changes in mineral metabolism during supplementation with @ IU of oral cholecalciferol daily during @ months .


Both @ ( OH ) vitamin D and @,@ ( OH ) @vitamin D increased significantly in the active treated group as compared to the placebo group ( @ % versus @ % ( P < @ ) and @ % versus -@ % ( P < @ ) ) .


No change was observed in urinary calcium excretion in the active group compared to the placebo group ( P = @ ) .


Fibroblast growth factor @ increased significantly by @ % ( P < @ ) in the active group .


However , there was no difference in changes in FGF@ between treatment groups ( P = @ ) .


High dose cholecalciferol significantly increases @ ( OH ) vitamin D and @,@ ( OH ) @vitamin D levels compared to placebo .


No changes in urinary calcium excretion or other measured components of the mineral metabolism were found between groups .


The present study analyses the relation between smoking status and the parameters used to assess vascular structure and function .


This cross-sectional , multi-centre study involved a random sample of @ participants from the EVIDENT study .


The smoking status , peripheral augmentation index and ankle-brachial index were measured in all participants .


In a small subset of the main population ( @ participants ) , the carotid intima-media thickness and pulse wave velocity were also measured .


After controlling for the effect of age , sex and other risk factors , present smokers have higher values of carotid intima-media thickness ( p = @ ) .


Along the same lines , current smokers have higher values of pulse wave velocity and lower mean values of ankle-brachial index but without statistical significance in both cases .


Among the parameters of vascular structure and function analysed , only the IMT shows association with the smoking status , after adjusting for confounders .


Children in Sub-Saharan Africa ( SSA ) are burdened by significant unmet mental health needs , but this region has limited access to mental health workers and resources to address these needs .


Despite the successes of numerous school-based interventions for promoting child mental health , most evidence-based interventions are not available in SSA .


This study will investigate the transportability of an evidence-based program from a developed country ( United States ) to a SSA country ( Uganda ) .


The approach includes task-shifting to early childhood teachers and consists of professional development ( five days ) to introduce strategies for effective behavior management and positive teacher-student interactions , and group-based consultation ( @ sessions ) to support adoption of effective practices and tailoring to meet the needs of individual students .


The design of this study is guided by two implementation frameworks , the Consolidated Framework for Implementation Research and the Teacher Training Implementation Model , that consider multidimensional aspects of intervention fidelity and contextual predictors that may influence implementation and teacher outcomes .


Using a cluster randomized design , @ schools in Uganda will be randomized to either the intervention group ( five schools ) or the waitlist control group ( five schools ) .


A total of @ to @ early childhood teachers will be enrolled in the study .


Teacher utilization of evidence-based strategies and practices will be assessed at baseline , immediate post-intervention ( six months after baseline ) , and at seven months post-intervention ( during a new academic year ) .


Fidelity measures will be assessed throughout the program implementation period ( during professional development and consultation sessions ) .


Individual teacher and contextual factors will be assessed at baseline .


Data will be collected from multiple sources .


Linear mixed-effect modeling , adjusting for school nesting , will be applied to address study questions .


The study will produce important information regarding the value of an evidence-based early intervention , and a theory-guided implementation process and tools designed for use in implementing early childhood evidence-based programs in SSA countries or resource-constrained community settings .


Soft-tissue augmentation with fillers is an aesthetic procedure for restoring age-related volume loss .


To compare neocollagenesis and elastin production stimulated by Radiesse ( calcium hydroxylapatite ; CaHA , Merz Pharmaceuticals GmbH ) and a hyaluronic acid-based filler ( HA ; Juvderm VOLUMA ) .


Twenty-four women , aged @-@ , participated in this split-face , comparative study .


Punch biopsies were taken @ and @ months after supraperiostal injection of each filler into the ipsilateral or contralateral postauricular area .


Samples were analyzed for collagens type I and III , elastin , Ki-@ , and inflammatory and angiogenic markers .


At month @ , collagen type III was greater with CaHA vs HA ( P = @ ) .


By month @ , type I staining was higher with CaHA vs HA ( P = @ ) , whereas type III was lower with CaHA than HA ( P = @ ) .


Staining for elastin , Ki-@ and angiogenesis was greatest with CaHA at both timepoints .


Inflammatory markers increased most with HA treatment .


CaHA resulted in more active , physiologic remodeling of the extracellular matrix than HA by stimulating a two-step process whereby collagen type I gradually replaced type III .


Increased elastin stimulated by CaHA also indicates active remodeling .


The results of this study suggest that , in the first @ months after treatment , by reconstituting tissue homeostasis without inducing inflammation suggests CaHA has more desirable characteristics for a dermal filler than HA .


Experimental evidence suggests that the inhalational anesthetic sevoflurane has a cardioprotective effect .


Our objective was to determine if sedation with sevoflurane will reduce infarct size in patients with acute myocardial infarction ( MI ) who are treated with primary percutaneous coronary intervention ( PCI ) .


We randomized @ patients presenting with a first acute ST-elevation MI treated by primary PCI within @ hours from symptom onset to sedation with sevoflurane inhalation or standard sedation ( control ) .


Coronary flow at the end of PCI was assessed by corrected Thrombolysis In Myocardial Infarction frame count .


Myocardial reperfusion was assessed by ST-segment resolution @ minutes post-PCI .


Infarct size was assessed by release of creatinine kinase ( CK ) and troponin T.


There was no difference in the primary end point : troponin T or CK release adjusted to the area at risk , between groups .


However , among patients with anterior MI , there was a trend toward lower CK ( P = @ ) and nonsignificant decrease in troponin ( P = @ ) levels in the sevoflurane group .


Corrected Thrombolysis In Myocardial Infarction frame count was @ @ in the sevoflurane group and @ @ in the control group ( P = @ ) .


There was more ST resolution in patients treated by sevoflurane @ % @ % versus @ % @ % ( P = @ ) .


Sevoflurane had no significant adverse effect during administration .


Sevoflurane administration during primary PCI did not reduce infarct size .


There was a trend toward a reduction in infarct size among patients with anterior MI .


Sevoflurane administration was associated with improvement in ST-segment resolution .


To compare a motivational intervention ( MI ) focused on increasing involvement in @-Step groups ( TSGs ; e.g. Alcoholics Anonymous ) versus brief advice ( BA ) to attend TSGs .


Patients were assigned randomly to either the MI or BA condition , and followed-up at @ months after discharge .


One hundred and forty substance use disorder ( SUD ) patients undergoing in-patient detoxification ( detox ) in Norway .


The primary outcome was TSG affiliation measured with the Alcoholics Anonymous Affiliation Scale ( AAAS ) , which combines meeting attendance and TSG involvement .


Substance use and problem severity were also measured .


At @ months after treatment , compared with the BA group , the MI group had higher TSG affiliation -LSB- @ point higher AAAS score ; @ % confidence interval ( CI ) = @ to @ ; P = @ -RSB- .


The MI group reported @ fewer days of alcohol use ( @ versus @ days ; @ % CI = -@ to -@ ; P = @ ) and @ fewer days of drug use ( @ versus @ days ; @ % CI = -@ to -@ ; P = @ ) ; however , abstinence rates and severity scores did not differ between conditions .


Analyses controlling for duration of in-patient treatment did not alter the results .


A motivational intervention in an in-patient detox ward was more successful than brief advice in terms of patient engagement in @-Step groups and reduced substance use at @ months after discharge .


There is a potential benefit of adding a maintenance-focused element to standard detox .


To compare epithelial connective tissue graft vs porcine collagen matrix for sealing postextraction sockets grafted with deproteinised bovine bone .


A total of @ patients , who needed a maxillary tooth to be extracted between their premolars and required a delayed , fixed , single implant-supported restoration , had their teeth atraumatically extracted and their sockets grafted with deproteinised bovine bone .


Patients were randomised according to a parallel group design into two arms : socket sealing with epithelial connective tissue graft ( group A ) vs porcine collagen matrix ( group B ) .


Outcome measures were : implant success and survival rate , complications , horizontal and vertical alveolar bone dimensional changes measured on Cone Beam computed tomography ( CBCT ) scans at three levels localised @ , @ , and @ mm below the most coronal aspect of the bone crest ( levels A , B , and C ) ; and between the palatal and buccal wall peaks ( level D ) ; and peri-implant marginal bone level changes measured on periapical radiographs .


@ patients were randomised to group A and @ to group B. No patients dropped out .


No failed implants or complications were reported @ year after implant placement .


Five months after tooth extraction there were no statistically significant differences between the @ groups for both horizontal and vertical alveolar bone dimensional changes .


At level A the difference was @ @ ; @ % CI @ to @ mm ( P = @ ) , at level B it was @ @ ; @ % CI -@ to @ ( P = @ ) , at level C it was @ @ ; @ % CI -@ to @ mm ( P = @ ) and at level D it was @ @ ; @ % CI -@ to @ mm ( P = @ ) .


One year after implant placement there were no statistically significant differences between the @ groups for peri-implant marginal bone level changes ( difference : @ @ mm ; @ % CI -@ to @ ; P = @ ) .


When teeth extractions were performed atraumatically and sockets were filled with deproteinised bovine bone , sealing the socket with a porcine collagen matrix or a epithelial connective tissue graft showed similar outcomes .


The use of porcine collagen matrix allowed simplification of treatment because no palatal donor site was involved .


Standard treatment for patients with chronic hepatitis C genotype @ ( CHC G-@ ) infection includes pegylated interferon plus ribavirin ( PEG-RBV ) for @ weeks .


Shorter treatment regimen would be more acceptable due to lower cost and fewer side-effects .


We aimed to compare the efficacy of @ week PEG-RBV therapy with standard @ week therapy in CHC G-@ patients who achieve complete early virological response ( cEVR ) .


Consecutive treatment-nave patients with CHC G-@ were treated with pegylated interferon a@b ( @ g/kg/week ) or @a ( @ g/week ) and weight based ribavirin .


Patients who achieved cEVR at @ weeks -LSB- undetectable HCV RNA irrespective of RVR ( rapid virological response ) -RSB- were randomized into - group A ( @ weeks therapy ) and group B ( @ weeks therapy ) .


Primary end-point was achievement of sustained virological response ( SVR ) at @ weeks of follow up .


Out of the total @ patients started on treatment , @ ( @ % ) achieved cEVR , and were randomized into group A ( n = @ ) and group B ( n = @ ) .


Fifty-five ( @ % ) patients in group A and @ ( @ % ) in group B completed therapy .


The overall SVR rate in group A was @ % ( @/@ ) and group B was @ % ( @/@ ) ( p = @ ) .


SVR rates in the two groups were comparable in all patient sub-groups according to factors like viral load ( or > @,@ IU/mL ) , RVR ( achieved/not achieved ) , age ( or > @ years ) , body mass index ( or > @ ) and cirrhosis ( present/absent ) .


In CHC G-@ patients who achieve cEVR , @ weeks PEG-RBV therapy is as effective as standard @ weeks therapy , irrespective of other host or virological factors .


To compare the analgesic efficacy of @ types of anesthetic techniques-topical and topical associated with cryoanalgesia-during cataract surgery .


Department of Ophthalmology , University of So Paulo , Ribeiro Preto , Brazil .


Prospective randomized study .


Patients with symmetrical bilateral cataract had phacoemulsification with the use of an intraocular irrigation solution at room temperature in @ eye and a cold ( @C ) solution in the contralateral eye ( Group @ ) .


The pain related to the procedure was assessed using a visual analog scale ranging from @ to @ , with @ representing no pain and @ the worst pain .


In addition , endothelial cell loss , the change in corneal thickness , and visual acuity were evaluated @ days @ ( SD ) after each surgery .


The surgery duration , total irrigation volume , phacoemulsification time , and ultrasound power used were analyzed .


The study enrolled @ patients ( @ eyes ) .


There was no statistically significant difference in the mean pain score between Group @ ( @ @ ) and Group @ ( @ @ ) ( P = @ , paired t test ) .


No significant difference was found in the mean corneal endothelial cell loss ( Group @ : @ % @ % ; Group @ : @ % @ % ; P = @ ) , corneal thickness increase ( Group @ : @ @ m ; Group @ : @ @ m ; P = @ ) , or visual acuity gain ( Group @ : @ @ logMAR ; Group @ : @ @ logMAR ; P = @ ) .


There is no difference in the intensity of pain during phacoemulsification with the use of topical anesthesia or topical anesthesia associated with cryoanalgesia .


To assess the effectiveness of acupuncture combined with selective serotonin reuptake inhibitors ( SSRIs ) for patients with depression in hospital using a pragmatic randomised controlled trial .


@ patients with depression were randomly divided into two groups ( randomisation ratio @:@ for treatment and control groups ( CGs ) , respectively ) and @ patients completed the study .


The @ patients in the treatment group ( TG ) underwent acupuncture and received an SSRI and the @ patients in the CG received an SSRI only .


The @-item Hamilton Depression Rating Scale ( HDRS-@ ) was used to quantitatively assess patients after @ , @ , @ and @weeks of treatment .


The mean ( SD ) baseline total HDRS scores were @ ( @ ) and @ ( @ ) in the TG and CG , respectively .


After the first week of treatment the HDRS score for the TG was reduced to @ ( @ ) , significantly different from the score of @ ( @ ) for the CG , p < @ .


This significant difference was maintained to the end of the @-week treatment period , when HDRS scores had fallen to @ ( @ ) and @ ( @ ) for the TG and CG , respectively .


Acupuncture combined with an SSRI showed a statistically significant benefit for patients with depression in hospital over the @-week period compared with SSRIs alone .


This reduction in symptoms started in the first week and continued throughout the @weeks of treatment .


The aim of this study was to evaluate the population pharmacokinetics ( PK ) and exposure-response relationship of edoxaban in patients with non-valvular atrial fibrillation ( AF ) .


Concentration data from @,@ subjects in @ clinical studies ( eight phase I , one phase II , and two phase III ) were used to perform a population PK analysis , including estimation of the bioavailability and quantification of the effects of P-glycoprotein ( P-gp ) inhibitors as well as renal impairment on edoxaban PK .


The potential relationship between edoxaban PK exposure and incidence of bleeding events was explored based on data from @ AF patients .


Absolute bioavailability of edoxaban was estimated as @ % .


With oral dosing of edoxaban , co-administration of various P-gp inhibitors significantly increased edoxaban bioavailability and decreased volume of distribution ( V @ ) , resulting in a predicted increase of @-@ % in area under the curve ( AUC ) and @-@ % in C max .


A much smaller increase was seen in edoxaban concentration at @ h post-dose ( C @ , -@ to @ % ) , due to decreased V @ and shortened elimination half-life .


With IV dosing of edoxaban , co-administration of the P-gp inhibitor quinidine decreased both edoxaban clearance ( CL ) and V @ , resulting in an increase of @ % in AUC and @ % in C @ .


Creatinine clearance was a significant covariate on renal clearance , whereas age and body weight significantly affected nonrenal clearance .


Model-predicted steady state C min was slightly higher , but AUC was comparable for patients who had severe renal impairment and received edoxaban @ mg once daily ( QD ) versus patients who had normal renal function or mild renal impairment and received edoxaban @ mg QD .


Exposure-response analysis suggested that edoxaban C min and country/region are significantly associated with the incidence of bleeds .


The model provided reasonable estimation with regard to the absolute bioavailability of edoxaban , the magnitude of change in edoxaban exposure upon co-administration of P-gp inhibitors , and the impact of renal impairment on edoxaban clearance .


Analysis results supported a @ % dose reduction scheme for subjects with severe renal impairment .


Further confirmation will be sought by incorporating clinical safety and efficacy information from larger phase III trials .


We sought to determine if outcomes with exercise training in heart failure ( HF ) vary according to ventricular pacing type .


Heart Failure : A Controlled Trial Investigating Outcomes of Exercise Training ( HF-ACTION ) randomized @,@ outpatients with HF and left ventricular ejection fraction @ % to usual care plus exercise training or usual care alone .


We examined the relationship between outcomes and randomized treatment according to ventricular pacing status with the use of Cox proportional hazards modeling .


In HF-ACTION @,@ patients ( @ % ) had an implanted cardiac rhythm device : @ with right ventricular ( RV ) and @ with biventricular ( BiV ) pacemakers .


Patients with pacing devices were older , more frequently white , and had lower peak VO@ ( P < @ for all ) .


Peak VO@ improved similarly with training in groups with and without pacing devices .


The primary composite end point-all-cause death or hospitalization-was reduced only in patients randomized to exercise training without a device ( hazard ratio -LSB- HR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ -LSB- P = @ -RSB- ; RV lead : HR @ , @ % CI @-@ @ -LSB- P = @ -RSB- ; BiV pacing : HR @ , @ % CI @-@ @ -LSB- P = @ -RSB- ; interaction P = @ ) .


Exercise training may improve exercise capacity in patients with implanted cardiac devices .


However , the apparent beneficial effects of exercise on hospitalization or death may be attenuated in patients with implanted cardiac devices and requires further study .


Inhibition of dipeptidyl peptidase @ ( DPP@ ) is thought to intensify the physiological effects of the incretin hormones .


We investigated the effects of DPP@ inhibition on plasma levels of glucose-dependent insulinotropic polypeptide ( GIP ) , glucagon-like peptide @ ( GLP@ ) , incretin effect , glucose tolerance , gastrointestinal-mediated glucose disposal ( GIGD ) and gastric emptying in healthy subjects .


A randomised , controlled and open-labelled study .


Ten healthy subjects ( six women ; age , @ years ( means.e.m . )


; BMI , @kg/m ( @ ) ; fasting plasma glucose , @ mmol/l and HbA@c , @mmol/mol ( @ % ) ) were randomised to two-paired study days comprising a @-h @g oral glucose tolerance test ( OGTT ) with paracetamol ( A ) and an isoglycaemic intravenous ( i.v. ) glucose infusion ( B ) , with ( A@ + B@ ) and without ( A@ + B@ ) preceding administration of the DPP@ inhibitor sitagliptin .


Isoglycaemia was obtained in all subjects on the paired study days .


Significant increases in fasting levels and OGTT-induced responses of active GLP@ and GIP were seen after DPP@ inhibition .


No significant impact of DPP@ inhibition on fasting plasma glucose ( @ vs @ mmol/l , P = @ ) , glucose tolerance ( area under the curve ( AUC ) for plasma glucose , @ vs @mmol/lmin , P = @ ) or peak plasma glucose during OGTT ( @ vs @ mmol/l , P = @ ) was observed .


Neither incretin effect ( @ % ( without DPP@ inhibitor ) vs @ % ( with DPP@ inhibitor ) , P = @ ) , glucagon responses ( @ vs @pmol/lmin , P = @ ) , GIGD ( @ vs @ % , P = @ ) nor gastric emptying ( Tmax for plasma paracetamol : @ vs @min , P = @ ) changed following DPP@ inhibition .


These results suggest that acute increases in active incretin hormone levels do not affect glucose tolerance , GIGD , incretin effect , glucagon responses or gastric emptying in healthy subjects .


Patients @ years old ( `` older '' ) are often not included in randomized clinical trials ( RCT ) , but when they are , care in an RCT might improve quality of life ( QoL ) .


We conducted a prospective comparison of QoL among older women receiving standard chemotherapy from the same cooperative group physicians in an RCT vs. an observational study ( `` off-trial '' ) .


Older women with invasive , non-metastatic breast cancer ( n = @ RCT ; @ off-trial ) were included .


Linear mixed-effects models tested associations between chemotherapy on - vs. off-trial and changes in EORTC ( European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire ) QoL scores over @ months , controlling for pre-treatment QoL , age , education , tumor factors , comorbidity , and other covariates .


Anthracycline regimens were used by @ % of women treated on-trial vs. @ % of those treated off-trial .


Women in the RCT reported an adjusted mean increase of @ points ( @ % CI @ , @ ) in global QoL at @ months ( vs. mid-treatment ) , while women treated off-trial had only an adjusted improvement of @ points ( @ % CI @ , @ ; p = @ for difference in mean changes ) .


Women in the RCT had significantly greater improvement in emotional function than those treated off-trial , controlling for baseline ; they also had greater reductions in therapy side effects and fatigue at @ months than women off-trial , controlling for covariates .


There may be different QoL trajectories for older women undergoing breast cancer chemotherapy on - vs. off-trial .


If confirmed , the results suggest that the extra monitoring and communication within an RCT could provide the infrastructure for interventions to address symptoms and improve QoL for the growing older cancer population .


Acute cellular rejection ( AR ) after lung transplantation may result in significant morbidity and mortality both on the short and long term .


Transbronchial biopsy through flexible bronchoscopy is highly sensitive for the diagnosis of AR , but reproducibility of histopathologic interpretation is less convincing .


Probe-based confocal laser endomicroscopy ( pCLE ) , a novel imaging tool in the field of respiratory medicine , enables real-time imaging of the pulmonary acini .


We performed @ bronchoscopies in lung transplant recipients , combining both transbronchial biopsies and pCLE .


We conducted an observational survey for pCLE findings in AR .


Calculations for cellularity showed a median cell count ( ACA ) of @ ( IQR @ to @ ) cells per microscopic field for AR and @ ( IQR @ to @ ) cells per microscopic field for matched controls ( p = @ ) .


Cellular autofluorescence in the AR group was @,@ ( @ ) units and @ ( @ ) units for the matched controls ( p = @ ) .


Autofluorescent cells were present in @ % ( @ ) of the recorded frames in the AR group and in only @ % ( @ ) of the recorded frames in the control group ( p = @ ) .


Contingency analysis for the presence/absence of ACA in the AR group versus the control group showed a sensitivity of @ and a specificity of @ ( relative risk = @ -LSB- @ % CI @ to @ -RSB- , p = @ ) .


The consecutive application of @ pCLE criteria resulted in a sensitivity of @ and a specificity of @ for detection of AR .


Our observational survey suggests the existence of specific pCLE characteristics in patients with AR .


Further efforts are necessary to validate these findings prospectively .


Noroviruses are the most common cause of gastroenteritis in the United States .


An understanding of the infectious dose of these viruses is important for risk assessment studies .


Healthy adults were enrolled in a randomized , double-blind , placebo-controlled evaluation of different dosages of Norwalk virus .


Eligible subjects were monitored for clinical gastroenteritis , and infection status was determined .


The presence of virus in vomitus was also assessed .


Fifty-seven persons were enrolled ; @ received placebo and an additional @ persons were considered to be nonsusceptible on the basis of being secretor negative .


Twenty-one persons were infected ( all blood group O or A ) , and @ % of those infected developed viral gastroenteritis .


The @ % human infectious dose was calculated to be @ reverse transcription polymerase chain reaction units ( approximately @ genomic equivalents -LSB- gEq -RSB- ) for secretor-positive blood group O or A persons and @ ( approximately @ gEq ) for all secretor-positive persons .


The time of illness onset was inversely correlated with inoculum dose .


The maximal concentration of virus shedding was higher for persons with gastroenteritis .


Norwalk virus was identified in @ of @ ( @ % ) vomitus samples at a median concentration of @ @ gEq/mL .


The @ % human infectious dose measured is higher than previous estimates and similar to that of other RNA viruses .


Clinical Trials RegistrationNCT@ .


Hospital readmissions for acute exacerbations of COPD ( AECOPDs ) pose burdens to the health-care system and patients .


A current gap in knowledge is whether a predischarge screening and educational tool administered to patients with COPD reduces readmissions and ED visits .


A single-center , randomized trial of admitted patients with AECOPDs was conducted at Henry Ford Hospital between February @ and April @ .


One hundred seventy-two patients were randomized to either the control ( standard care ) or the bundle group in which patients received smoking cessation counseling , screening for gastroesophageal reflux disease and depression or anxiety , standardized inhaler education , and a @-h postdischarge telephone call .


The primary end point was the difference in the composite risk of hospitalizations or ED visits for AECOPD between the two groups in the @ days following discharge .


A secondary end point was @-day readmission rate .


Of the @ patients , @ of @ in the control group ( @ % ) and @ of @ in the bundle group ( @ % ) were readmitted within @ days .


The risk of ED visits or hospitalizations within @ days was not different between the groups ( risk difference , -@ % ; @ % CI , -@ % to @ % ; P = @ ) .


Overall , the time to readmission in @ and @ days was similar between groups ( log-rank test P = @ and @ , respectively ) .


A predischarge bundle intervention in AECOPD is not sufficient to reduce the @-day risk of hospitalizations or ED visits .


More resources may be needed to generate a measurable effect on readmission rates .


Opioid-induced constipation is common and debilitating .


We investigated the efficacy and safety of naloxegol , an oral , peripherally acting , - opioid receptor antagonist , for the treatment of opioid-induced constipation .


In two identical phase @ , double-blind studies ( study @ , @ participants ; study @ , @ participants ) , outpatients with noncancer pain and opioid-induced constipation were randomly assigned to receive a daily dose of @ or @ mg of naloxegol or placebo .


The primary end point was the @-week response rate ( @ spontaneous bowel movements per week and an increase from baseline of @ spontaneous bowel movements for @ of @ weeks and for @ of the final @ weeks ) in the intention-to-treat population .


The key secondary end points were the response rate in the subpopulation of patients with an inadequate response to laxatives before enrollment , time to first postdose spontaneous bowel movement , and mean number of days per week with one or more spontaneous bowel movements .


Response rates were significantly higher with @ mg of naloxegol than with placebo ( intention-to-treat population : study @ , @ % vs. @ % , P = @ ; study @ , @ % vs. @ % , P = @ ; patients with an inadequate response to laxatives : study @ , @ % vs. @ % , P = @ ; study @ , @ % vs. @ % , P = @ ) ; in study @ , response rates were also higher in the group treated with @ mg of naloxegol ( intention-to-treat population , @ % vs. @ % , P = @ ; patients with an inadequate response to laxatives , @ % vs. @ % , P = @ ) .


A shorter time to the first postdose spontaneous bowel movement and a higher mean number of days per week with one or more spontaneous bowel movements were observed with @ mg of naloxegol versus placebo in both studies ( P < @ ) and with @ mg of naloxegol in study @ ( P < @ ) .


Pain scores and daily opioid dose were similar among the three groups .


Adverse events ( primarily gastrointestinal ) occurred most frequently in the groups treated with @ mg of naloxegol .


Treatment with naloxegol , as compared with placebo , resulted in a significantly higher rate of treatment response , without reducing opioid-mediated analgesia .


( Funded by AstraZeneca ; KODIAC-@ and KODIAC-@ ClinicalTrials.gov numbers , NCT@ and NCT@ , respectively . )


Patients with a pacing indication and first-degree atrioventricular ( AV ) - block pose a clinical challenge .


The prognostic impact of first-degree AV-block in patients with sinus node dysfunction and the impact of pacing in this setting are not known .


In the Mode Selection Trial ( MOST ) , @,@ patients with sinus node dysfunction were randomized to either dual-chamber ( DDD-R ) or ventricular ( VVI-R ) pacing and followed for a median of @ months .


We report on clinical outcomes in patients with first-degree AV-block ( PR interval > @ ms ) compared with patients who had a normal PR interval at baseline .


Patients with first-degree AV-block ( n = @ ) were older ( median -LSB- Q@ , Q@ -RSB- ; @ -LSB- @ , @ -RSB- years vs @ -LSB- @ , @ -RSB- years , P < @ ) , more often male ( @ % vs @ % , P = @ ) , and had more comorbidity , such as hypertension ( @ % vs @ % , P = @ ) and heart failure ( @ % vs @ % , P = @ ) than patients with normal AV-conduction ( n = @,@ ) .


In multivariable analyses , patients with first-degree AV-block were at greater risk of death , stroke , or heart failure hospitalization ( hazard ratio -LSB- HR -RSB- @ , @ % confidence interval -LSB- CI -RSB- @-@ @ , P = @ ) .


A trend towards a higher incidence of atrial fibrillation was seen ( HR @ , @ % CI @-@ @ , P = @ ) .


No significant interactions between pacing arm and prolonged versus normal PR were found for any endpoint , and hazard ratios were consistent across subgroups .


First-degree AV-block is associated with more advanced disease but is still an independent predictor of poor clinical outcome .


Neither DDD-R nor VVI-R pacing , as employed in MOST , eliminate the negative effects associated with first-degree AV-block .


This study evaluated the pharmacokinetics of a granule formulation of dolutegravir developed as an alternative to tablets for use in paediatric populations .


A randomized , open-label study in healthy adults was carried out .


Subjects received five treatments in a crossover design : a single dose of dolutegravir @ mg as a tablet and dolutegravir @ mg in @ g of granule administered directly to mouth or mixed with purified water , water containing high cation concentrations or milk-based infant formula .


Study treatments were separated by @ days .


Safety evaluations and serial pharmacokinetic sampling were done during each treatment period .


A non-compartmental pharmacokinetic analysis was performed ; geometric least-squares mean ratios and @ % CIs were generated for treatment comparison .


Palatability was assessed by questionnaire .


Plasma dolutegravir exposures in all granule treatment arms exceeded those of tablet formulation .


The mean area under the curve from time @ to infinity ( AUC ( @ - ) ) and maximum concentrations were @-@ % and @-@ % higher , respectively .


Pharmacokinetics were similar when dolutegravir was mixed with purified or cation-containing water .


Dolutegravir was well tolerated , with no withdrawals due to adverse events .


Taste was rated acceptable for all treatments .


The exposure of dolutegravir after administration of granule formulation alone , with different types of water and with milk formula , exceeded that of the tablet .


The similarity of dolutegravir exposure seen with the granule formulation demonstrates that dolutegravir granule can be given without restriction on the type of liquid or can be administered directly to the mouth ( for example , when potable water is not available ) .


To establish during late gestation and early lactation the effects of supplementing silymarin , a natural hepatoprotective substance , combined with a powerful antioxidant , lycopene , on milk production and on serum biomarkers of oxidative status .


Italian Friesian dairy cows were given individually a supplement containing a mixture of silymarin ( @ g/day/cow ) and lycopene ( @ g/day/cow ) ( n = @ ) or no supplement ( control ; n = @ ) .


Treatment was administered from @ days before the expected calving date to the first @ days in milk .


At @ days before the expected calving date , at calving , and @ days postpartum , body condition score ( BCS ) and concentrations in serum of reactive oxygen metabolites ( ROM ) , total antioxidant capacity ( OXY ) and thiobarbituric acid reactive substances ( TBARS ) were evaluated .


Bodyweight , milk production , and somatic cell count ( SCC ) were determined at @ , @ and @ days postpartum .


The mean time of treatment prior to calving was @ ( min @ , max @ ) days .


Compared with control cows , treatment increased energy corrected milk yield ( @ vs. @ ( SEM @ ) kg/day ; p = @ ) and milk fat yield ( @ vs. @ ( SEM @ ) kg/day ; p = @ ) over the first @ days of lactation .


Treated cows had lower mean log@ SCC compared to control cows ( @ vs. @ ( SEM @ ) log@ cells/mL ) and had lower overall concentration of TBARS ( @ vs. @ ( SEM @ ) nM/mL ; p < @ ) , but similar concentrations of ROM and OXY in serum .


However there was a treatment by time interaction ( p = @ ) for OXY , and at calving mean OXY was higher in treated cows compared with pre-calving values ( p < @ ) .


Despite the acknowledged limitation of the study , i.e. the small number of animals , our results suggest that silymarin and lycopene , as health-beneficial feed supplements , may help dairy cows in metabolic adaptation during the first stages of lactation .


During the peripartum period dairy cows suffer moderate-to-severe fatty liver and from an overproduction of free radicals .


The supplementation of a mixture of silymarin and lycopene during these stressful days may be useful to mitigate these metabolic disorders with beneficial effects on the subsequent lactation .


Part @ of this phase III study was a randomized , double-blind , parallel-group , placebo-controlled , multicenter study of caregiver administered diazepam auto-injector ( AI ) in subjects with acute repetitive seizures ( ARS ) and demonstrated that diazepam AI was well-tolerated and significantly more effective than placebo AI in delaying the time to next seizure or rescue .


Part @ of this study , presented herein , was an open-label continuation to assess the long-term safety and effectiveness of diazepam AI for the treatment of ARS .


Of the @ subjects randomized in part @ , @ continued into part @ and were provided open-label diazepam AI .


Effectiveness measures were time to next seizure or rescue , number of subsequent rescues by type ( rescue medication , emergency room visit , or other medical care ) , and number of subsequent seizures during the @-h follow-up period .


Safety data ( adverse events and respirations < @/min ) were also collected .


During the open-label part @ study , @ subjects were administered a total of @,@ diazepam AI treatments ( median @ ; range @-@ ) , of which @,@ ( @ % ) were effective with no subsequent seizure or rescue during the @-h follow-up period .


Median number of subsequent seizures experienced by subjects was one ( range @-@ ) .


Of the @,@ administrations , @ ( @ % ) required use of rescue medication , @ ( @ % ) required a visit to an emergency room , and @ ( @ % ) required other rescue medical care .


In most ( @ % ) of subjects with treatment-emergent adverse events ( TEAEs ) , TEAEs were mild or moderate in severity .


Commonly reported treatment-related TEAEs were injection-site pain ( @ % ) , injection-site hemorrhage ( @ % ) , and injection-site bruising ( @ % ) .


Although three subjects met the predefined respiratory rate threshold , none were considered clinically significant or reported as AEs .


Long-term treatment with diazepam AI administered by trained caregivers in an outpatient setting to treat ARS is a safe and effective option .


A PowerPoint slide summarizing this article is available for download in the Supporting Information section here .


The prognostic importance of the speed of early hematoma growth in acute intracerebral hemorrhage ( ICH ) has not been well established .


We aimed to determine the association between the rate of increase in hematoma volume and major clinical outcomes in the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial ( INTERACT ) studies .


The effects of early intensive blood pressure ( BP ) lowering according to the speed of hematoma growth were also investigated .


Pooled analyses of the INTERACT@ ( n = @ ) and INTERACT@ ( n = @,@ ) studies-randomized controlled trials of patients with spontaneous ICH with elevated systolic BP , randomly assigned to intensive ( target systolic BP < @ mm Hg ) or guideline-based ( < @ mm Hg ) BP management .


The speed of ultraearly hematoma growth ( UHG ) was defined as hematoma volume ( mL ) / onset-to-CT time ( hours ) .


Primary outcome was death or major disability ( modified Rankin Scale score of @-@ ) at @ days .


Among a total of @,@ patients ( @ % ) with information on UHG and outcome , median speed of UHG was @ mL/h .


There was a linear association between UHG and outcome : multivariable-adjusted odd ratios @ ( @ % confidence interval @-@ @ ) for @-@ mL/h and @ ( @-@ @ ) for > @ mL/h vs the < @ mL/h group .


There were no clear differences in the effects of intensive BP lowering according to @ speeds of UHG on outcome ( p = @ for homogeneity ) .


The speed of UHG in patients with ICH was continuously associated with increased risks of death or major disability , and from lower levels than previously reported ( @ mL/h ) .


The benefits of intensive BP lowering appear to be independent of the speed of bleeding .


Photodynamic therapy is an effective tool in the management of some forms of skin cancer and generalized solar dermopathy and can be beneficial in the management of acne vulgaris .


When used as an area treatment one of the main limiters is the quite severe burning pain that patients feel during the illumination phase of the treatment .


To examine the effectiveness of a plant derived anti-nociceptive spray applied prior to and during large area photodynamic therapy .


A split face or left arm versus right arm , placebo controlled trial was performed on @ patients to assess the effectiveness of the spray in reducing pain perception .


There was a statistically significant reduction in pain at all illumination points during the illumination phase but no significant difference in discomfort levels in the first @ h post illumination .


Only large area photodynamic therapy treatment was performed during the study .


No conclusions can be drawn for small area treatments .


Use of a simple , plant derived anti-nociceptive spray can reduce the discomfort experienced by patients undergoing photodynamic therapy to large areas .


To compare the effectiveness of the traditional center of tibial plateau as the entry point and digital technology in the design of intramedullary tibial nail point positioning method in total knee arthroplasty ( TKA ) .


Between October @ and October @ , @ cases undergoing unilateral TKA and meeting the selection criteria were randomly divided into @ groups : in group A ( @ cases ) , the tibial plateau center as the entry point of tibial intramedullary positioning was used ; in group B ( @ cases ) , Mimics @ software to simulate the guide rod point of tibial intramedullary positioning was used .


There was no significant difference in gender , age , etiology , disease duration , sides , and preoperative knee range of motion , Hospital for Special Surgery ( HSS ) score , and Western Ontario and McMaster University Osteoarthritis Index ( WOMAC ) between @ groups ( P > @ ) .


Postoperative X-ray films were taken to measure the tibiofemoral angle and tibial angle ; knee range of motion , and HSS and WOMAC scores were used to assess the activity of knee .


The entry point of group B was located in front of the center of tibial plateau , which was inconsistent with the traditional entry point .


The incision healed by first intention in all patients of @ groups .


The patients were followed up @ to @ months ( mean , @ months ) .


The X-ray measurement at @ week after operation showed no significant difference in tibiofemoral angle between @ groups ( t = -@ , P = @ ) , but the anteroposterior and lateral tibial angles of group A were significantly lower than those of group B ( P < @ ) .


The knee range of motion , HSS score , and WOMAC score of @ groups were significantly higher at @ and @ months after operation when compared with preoperative values ( P < @ ) , and the values at @ months were significantly increased than those at @ months after operation ( P < @ ) .


HSS score and WOMAC score had no significant difference between @ groups at @ months after operation ( P > @ ) , but the scores of group B were significantly higher than those of group A at @ months ( P < @ ) .


The knee range of motion of group B was significantly better than that of group A at @ months after operation ( t = @ , P = @ ) , but no significant difference was found between @ groups at @ months ( t = @ , P = @ ) .


Compared with the traditional intramedullary guide rod insertion point positioning , digital individualized design of entry point positioning has the advantages of more accurate lower limb force line , better recovery of knee function , and earlier @ degrees activities , but the long-term effectiveness needs further observation .


Chronic alcohol abuse has been traditionally associated with impaired cognitive abilities .


The deficits are most evident in higher order cognitive functions , such as abstract reasoning , problem solving and visuospatial processing .


The present study sought to increase current understanding of the neuropsychological basis of poor abstract reasoning abilities in alcohol-dependent subjects using functional magnetic resonance imaging ( fMRI ) .


An abstract reasoning task-based fMRI study was carried out on alcohol-dependent subjects ( n = @ ) and healthy controls ( n = @ ) to examine neural activation pattern .


The study was carried out using a @-T whole-body magnetic resonance scanner .


Preprocessing and post processing was performed using SPM @ software .


Behavioral data indicated that alcohol-dependent subjects took more time than controls for performing the task but there was no significant difference in their response accuracy .


Analysis of the fMRI data indicated that for solving abstract reasoning-based problems , alcohol-dependent subjects showed enhanced right frontoparietal neural activation involving inferior frontal gyrus , post central gyrus , superior parietal lobule , and occipito-temporal gyrus .


The extensive activation observed in alcohol dependents as compared to controls suggests that alcohol dependents recruit additional brain areas to meet the behavioral demands for equivalent task performance .


The results are consistent with previous fMRI studies suggesting decreased neural efficiency of relevant brain networks or compensatory mechanisms for the execution of task for showing an equivalent performance .