The aim of this study was to assess whether the use of a synthetic , bioabsorbable staple line reinforcement material with circular staplers would reduce postoperative anastomotic leakage in patients with a colorectal , coloanal , or ileoanal anastomosis .


This was a randomized study that compared outcomes in patients in whom the reinforcement material was used with those in patients who were not given the material .


This study was conducted at several centers in the United States .


The @ patients ( @ in the reinforcement group and @ control subjects ) underwent surgery for a variety of conditions , but most ( n = @ ) were treated for rectal cancer .


The main outcome measures were occurrence of anastomotic leaks and other complications according to the study protocol .


There were no significant differences in the @ study groups with respect to age , BMI , ASA physical status , operating time , diagnosis , previous chemoradiotherapy , surgical technique , or @-day complications , except for a higher rate of small-bowel obstruction ( p = @ ) and anastomotic stricture ( p = @ ) in the control group .


The overall anastomotic leak rate was @ % ( bioabsorbable staple line reinforcement , @ % ; no bioabsorbable staple line reinforcement , @ % ) .


The study was nonblinded and was terminated at the first planned interim analysis because of insufficient power to detect an intergroup difference in anastomotic leak rate in the time allotted for the investigation .


Reinforcing the circular staple line in colorectal anastomoses with bioabsorbable material did not significantly affect the anastomotic leak rate but may have reduced anastomotic strictures .


Most strictures did not require an anastomotic revision or delay in stoma closure .


The bioabsorbable material may positively affect some aspects of the healing of circular stapled colorectal anastomoses ; however , additional research on factors associated with anastomotic leakage is needed .


To develop a genomic signature that predicts benefit from trastuzumab in human epidermal growth factor receptor @-positive breast cancer .


DASL technology was used to quantify mRNA in samples from @,@ patients enrolled onto the Combination Chemotherapy With or Without Trastuzumab in Treating Women With Breast Cancer ( North Central Cancer Treatment Group N@ -LSB- NCCTG-N@ -RSB- ) adjuvant trastuzumab trial .


Cox proportional hazard ratios ( HRs ) , adjusted for significant clinicopathologic risk factors , were used to determine the association of each gene with relapse-free survival ( RFS ) for @ patients who received chemotherapy alone ( arm A ) and @ patients who received chemotherapy plus trastuzumab ( arms B and C ) .


Network and pathway analyses were used to identify key biologic processes linked to RFS .


The signature was built by using a voting scheme .


Network and functional ontology analyses suggested that increased RFS was linked to a subset of immune function genes .


A voting scheme model was used to define immune gene enrichment based on the expression of any nine or more of @ immune function genes at or above the @ quantile for the population .


This model was used to identify immune gene-enriched tumors in arm A and arms B and C. Immune gene enrichment was linked to increased RFS in arms B and C ( HR , @ ; @ % CI , @ to @ ; P < @ ) , whereas arm B and C patients who did not exhibit immune gene enrichment did not benefit from trastuzumab ( HR , @ ; @ % CI , @ to @ ; P = @ ) .


Enriched immune function gene expression as defined by our predictive signature was not associated with increased RFS in arm A ( HR , @ ; @ % CI , @ to @ ; P = @ ) .


Increased expression of a subset of immune function genes may provide a means of predicting benefit from adjuvant trastuzumab .


Finding current best evidence for clinical decisions remains challenging .


With @,@ new studies published every day , no single evidence-based resource provides all answers or is sufficiently updated .


McMaster Premium LiteratUre Service -- Federated Search ( MacPLUS FS ) addresses this issue by looking in multiple high quality resources simultaneously and displaying results in a one-page pyramid with the most clinically useful at the top .


Yet , additional logistical and educational barriers need to be addressed to enhance point-of-care evidence retrieval .


This trial seeks to test three innovative interventions , among clinicians registered to MacPLUS FS , to increase the quantity and quality of searching for current best evidence to answer clinical questions .


In a user-centered approach , we designed three interventions embedded in MacPLUS FS : ( A ) a web-based Clinical Question Recorder ; ( B ) an Evidence Retrieval Coach composed of eight short educational videos ; ( C ) an Audit , Feedback and Gamification approach to evidence retrieval , based on the allocation of ` badges ' and ` reputation scores . '


We will conduct a randomized factorial controlled trial among all the @ eligible medical doctors currently registered to MacPLUS FS at the hospitals affiliated with McMaster University , Canada .


Postgraduate trainees ( n = @ ) and clinical faculty/staff ( n = @ ) will be randomized to each of the three following interventions in a factorial design ( AxBxC ) .


Utilization will be continuously recorded through clinicians accounts that track logins and usage , down to the level of individual keystrokes .


The primary outcome is the rate of searches per month per user during the six months of follow-up .


Secondary outcomes , measured through the validated Impact Assessment Method questionnaire , include : utility of answers found ( meeting clinicians information needs ) , use ( application in practice ) , and perceived usefulness on patient outcomes .


Built on effective models for the point-of-care teaching , these interventions approach evidence retrieval as a clinical skill .


If effective , they may offer the opportunity to enhance it for a large audience , at low cost , providing better access to relevant evidence across many top EBM resources in parallel .


To determine effects of probiotic consumption on clinical and immunological parameters of seasonal allergic rhinitis ( SAR ) in an out-of-season single nasal allergen challenge .


In a study registered at ClinicalTrials.Gov ( NCT@ ) , a @-week dietary intervention was undertaken in @ patients with allergic rhinitis ( > @ years old ) .


Using a double-blinded , placebo-controlled anonymised design , the patients were divided equally into two groups .


One group was given a dairy drink containing Lactobacillus casei Shirota to ingest daily while the other consumed a similar drink without bacteria .


Participants attended the clinic on two consecutive days before the intervention and then again at the end of the study period .


On the first day of each @-day visit , following clinical examination , assessments were made of total nasal symptoms scores and peak nasal inspiratory flow .


Nasal scrapings , nasal lavage and blood were collected for laboratory analyses of cellular phenotypes , soluble mediator release and in vitro responses to pollen allergen .


These procedures were repeated @ hours following nasal allergen challenge .


Prior to and following intervention there were no detectable differences between study groups in measured clinical outcome .


After intervention , there were differences between groups in their percentages of CD@ + epithelial cells ( p = @ ) , CD@ + CD@ + non-epithelial cells ( p = @ ) , sIL-@RII release ( p = @ ) and IL-@ ( p = @ ) levels at the nasal mucosa .


Delivery of probiotic also suppressed production of sCD@ ( p = @ ) , TGF - ( p = @ ) and induced increased production of IFN - ( p = @ ) in supernatants of cultured peripheral blood .


This study did not show significant probiotic-associated changes with respect to the primary clinical endpoint .


An absence of overt clinical benefit may be due to an inability of single nasal challenges to accurately represent natural allergen exposure .


Nevertheless , oral delivery of probiotics produced changes of the immunological microenvironment at the nasal mucosa in individuals affected by SAR .


To assess the effects of patient-controlled abdominal compression on postural changes in systolic blood pressure ( SBP ) associated with orthostatic hypotension ( OH ) .


Secondary variables included subject assessments of their preferences and the ease-of-use .


Randomized crossover trial .


Clinical research laboratory .


Adults with neurogenic OH ( N = @ ) .


Four maneuvers were performed : moving from supine to standing without abdominal compression ; moving from supine to standing with either a conventional or an adjustable abdominal binder in place ; application of subject-determined maximal tolerable abdominal compression while standing ; and while still erect , subsequent reduction of abdominal compression to a level the subject believed would be tolerable for a prolonged period .


The primary outcome variable included postural changes in SBP .


Secondary outcome variables included subject assessments of their preferences and ease of use .


Baseline median SBP in the supine position was not affected by mild ( @mmHg ) abdominal compression prior to rising ( without abdominal compression : @mmHg ; interquartile range , @-@mmHg ; with the conventional binder : @mmHg ; interquartile range , @-@mmHg ; with the adjustable binder : @mmHg , interquartile range , @-@mmHg ; P = @ ) .


Standing without a binder was associated with an -@ mmHg ( interquartile range , -@ to -@ mmHg ) SBP decrease .


Levels of compression of @mmHg applied prior to rising with the conventional and adjustable binders blunted these drops to -@ mmHg ( interquartile range , -@ to -@ mmHg ; P = @ ) and -@ mmHg ( interquartile range , -@ to -@ mmHg ; P = @ ) , respectively .


Increasing compression to subject-selected maximal tolerance while standing did not provide additional benefit and was associated with drops of -@ mmHg ( interquartile range , -@ to -@ mmHg ; P = @ ) and -@ mmHg ( interquartile range , -@ to -@ mmHg ; P = @ ) for the conventional and adjustable binders , respectively .


Subsequent reduction of compression to more tolerable levels tended to worsen OH with both the conventional ( -@ mmHg ; interquartile range , -@ to -@ mmHg ; P = @ ) and adjustable ( -@ mmHg ; interquartile range , -@ to -@ mmHg ; P = @ ) binders .


Subjects reported no differences in preferences between the binders in terms of preference or ease of use .


These results suggest that mild ( @mmHg ) abdominal compression prior to rising can ameliorate OH , but further compression once standing does not result in additional benefit .


To compare the diagnostic accuracy of three-dimensional sonohysterography ( @D-SIS ) and office hysteroscopy in uterine cavity assessment after hysteroscopic metroplasty ( HM ) and determine the interrater/intrarater agreement for @D-SIS .


Prospective observational study .


University hospital , private hospital , and clinic .


One hundred forty-one women undergoing HM for septate uterus with a history of miscarriage and/or infertility .


@D-SIS and office hysteroscopy at @-@ weeks after HM .


Shape of the uterine cavity , length of the fundal notch ( @ or < @ cm ) , and the presence of intrauterine adhesions were assessed , and the interrater/intrarater agreement of @D-SIS was evaluated in @ randomly selected patients .


Uterine abnormalities were detected with the use of hysteroscopy in @ ( @ % ) of @ women .


@D-SIS was highly accurate ( @ % ) , sensitive ( @ % ) , and specific ( @ % ) , with a positive predictive value of @ % and a negative predictive value of @ % .


The diagnostic values of hysteroscopy and @D-SIS were not significantly different ( McNemar test ) .


@D-SIS showed substantial interrater/intrarater agreement regarding overall uterine cavity evaluation ( = @ and @ , respectively ) .


@D-SIS demonstrated substantial interrater/intrarater agreement for the postoperative evaluation of the uterine cavity , being as diagnostically accurate as hysteroscopy .


The use of second-look hysteroscopy may be limited to cases that require reoperation .


Obesity is associated with a higher risk of aggressive prostate cancer and alters circulating levels of insulin and adiponectin , two hormones that influence biologic processes implicated in carcinogenesis .


Results of some studies showed associations of circulating levels of adiponectin , insulin , and c-peptide ( a marker of insulin secretion ) with aggressive prostate cancer , but the size of these studies was limited .


A nested case-control study of @ aggressive prostate cancer cases -LSB- Gleason score @ ( @ +@ ) or T@-T@ -RSB- and @ age - and race-matched controls from the Cancer Prevention Study II Nutrition Cohort was conducted to determine the associations of prediagnostic plasma levels of c-peptide and adiponectin with risk of aggressive prostate cancer .


Neither circulating adiponectin nor c-peptide was associated with risk of aggressive prostate cancer .


In analyses of the highest-risk aggressive prostate cancer ( Gleason score @ or T@-T@ ) , the highest quartile of c-peptide , compared with the lowest , was associated with an OR of @ -LSB- @ % confidence interval ( CI ) , @-@ @ -RSB- .


Our findings provide no support for the hypothesis that adiponectin is associated with risk of aggressive prostate cancer but a possible association of high levels of c-peptide with particularly high-risk prostate cancer can not be ruled out .


These results indicate that changes in circulating levels of adiponectin and c-peptide do not play an important role in risk of aggressive prostate cancer .


Recent studies have thrown doubt on the true effectiveness of anti-depressants in light and moderate depression .


The aim of this study is to evaluate the impact of physical training and music therapy on a sample group of subjects affected by light to moderate depression versus subjects treated with pharmacological therapy only .


Randomized controlled study .


Patients were randomized into two groups .


Subjects in the pharmacotherapy group received a therapy with antidepressant drugs ; the exercise/music therapy group was assigned to receive physical exercise training combined with listening to music .


The effects of interventions were assessed by differences in changes in mood state between the two groups .


Medically eligible patients were screened with the Hamilton Anxiety Scale and with the Geriatric Depression Scale .


We used plasmatic cytokine dosage as a stress marker .


We recruited @ subjects ( mean age : @ @ , @ M/@ F ) .


In the pharmacotherapy group there was a significant improvement in anxiety only ( p < @ ) at @-months .


In the exercise/music therapy was a reduction in anxiety and in depression at @-months and at @-months ( p < @ ) .


We noted an average reduction of the level of TNF-a from @ ( @ ) pg/ml to @ ( @ ) pg/ml .


Our training may potentially play a role in the treatment of subjects with mild to moderate depression .


Further research should be carried out to obtain more evidence on effects of physical training and music therapy in depressed subjects .


Although retrievable inferior vena cava filters are frequently used in addition to anticoagulation in patients with acute venous thromboembolism , their benefit-risk ratio is unclear .


To evaluate the efficacy and safety of retrievable vena cava filters plus anticoagulation vs anticoagulation alone for preventing pulmonary embolism recurrence in patients presenting with acute pulmonary embolism and a high risk of recurrence .


Randomized , open-label , blinded end point trial ( PREPIC@ ) with @-month follow-up conducted from August @ to January @ .


Hospitalized patients with acute , symptomatic pulmonary embolism associated with lower-limb vein thrombosis and at least @ criterion for severity were assigned to retrievable inferior vena cava filter implantation plus anticoagulation ( filter group ; n = @ ) or anticoagulation alone with no filter implantation ( control group ; n = @ ) .


Initial hospitalization with ambulatory follow-up occurred in @ French centers .


Full-dose anticoagulation for at least @ months in all patients .


Insertion of a retrievable inferior vena cava filter in patients randomized to the filter group .


Filter retrieval was planned at @ months from placement .


Primary efficacy outcome was symptomatic recurrent pulmonary embolism at @ months .


Secondary outcomes were recurrent pulmonary embolism at @ months , symptomatic deep vein thrombosis , major bleeding , death at @ and @ months , and filter complications .


In the filter group , the filter was successfully inserted in @ patients and was retrieved as planned in @ of the @ patients in whom retrieval was attempted .


By @ months , recurrent pulmonary embolism had occurred in @ patients ( @ % ; all fatal ) in the filter group and in @ patients ( @ % ; @ fatal ) in the control group ( relative risk with filter , @ -LSB- @ % CI , @-@ @ -RSB- ; P = @ ) .


Results were similar at @ months .


No difference was observed between the @ groups regarding the other outcomes .


Filter thrombosis occurred in @ patients .


Among hospitalized patients with severe acute pulmonary embolism , the use of a retrievable inferior vena cava filter plus anticoagulation compared with anticoagulation alone did not reduce the risk of symptomatic recurrent pulmonary embolism at @ months .


These findings do not support the use of this type of filter in patients who can be treated with anticoagulation .


To evaluate the efficacy of a surgical no-touch isolation technique in primary hepatocellular carcinoma patients compared with traditional hepatectomy .


Eighty hepatocellular carcinoma patients were randomly divided into traditional hepatectomy ( n = @ ) and no-touch isolation technique groups ( n = @ ) .


We compared peripheral blood variations in alpha-fetoprotein mRNA , miRNA-@ , miRNA-@ , and miRNA-@ expression levels in both groups pre - and postoperatively using real-time fluorescent quantitative polymerase chain reaction .


The patients in the no-touch isolation technique group had better clinical curative effect .


In the traditional hepatectomy group , variations in alpha-fetoprotein mRNA copy number pre - and postoperatively indirectly indicated a significant increase in the number of exfoliated carcinoma cells induced by manipulating the liver , increasing the risk of postoperative recurrence and metastasis ( P < @ ) .


Traditional hepatectomy patients showed higher increases in miRNA-@ and miRNA-@ expression than those in the no-touch isolation technique group ( P < @ ) .


Tumor resection resulted in preoperative expression and high postoperative expression of miRNA-@ .


No-touch isolation technique patients showed a slight and significant increase ( P < @ ) in miRNA-@ , which was positively correlated with postoperative liver function index .


Conclusion : The no-touch isolation technique is more effective than traditional hepa - tectomy in tumor resection for primary hepatocellular carcinoma .


To report the effect of nepafenac ( @ % ) eye drops on intraocular pressure in eyes with cataract .


Prospective randomized clinical trial .


Three hundred and twenty-seven patients with bilateral cataracts in an institutional setting were included .


All patients had a baseline intraocular pressure ( IOP ) @ mm Hg without a history of intraocular surgery in the past @ months .


One eye of each individual was randomized to the treatment group , with the other eye acting as a control .


Nepafenac ( @ % ) eye drops were instilled @ times a day in the eye that received treatment .


Intraocular pressure ( IOP ) with Goldmann applanation tonometer ( GAT ) was measured at baseline and at @ and @ weeks .


Proportion of eyes with an IOP elevation of > @ mm Hg was the main outcome measure .


The mean age of the participants was @ @ years .


Participants included @ female and @ male patients .


The mean IOP at baseline in the treated and control eyes was , respectively , @ @ mm Hg and @ @ mm Hg , which reduced to @ @ mm Hg and @ @ mm Hg , respectively , at the end of @ weeks .


This reduction in IOP in both groups was significant ( P < @ ) .


The difference between the IOP in the treated and control eyes at @ weeks was not statistically significant ( P = @ ) .


One eye in the treated group and @ eyes in the control group had an IOP elevation of > @ mm Hg .


Nepafenac eye drops do not increase the IOP .


They can possibly be used as an alternative to steroid medications where steroid responsiveness is a concern .


Partitioning exercise by @-legged cycling is more effective than conventional training in patients with chronic obstructive pulmonary disease .


Similarly , inhaling helium-hyperoxia can extend conventional exercise tolerance .


This study aimed to determine whether breathing helium-hyperoxia could increase the tolerance of a high-intensity exercise session achieved by @-legged cycling .


Participants completed @ high-intensity , constant power , @-legged cycle tests to intolerance ( tlimit ) .


In a randomized order , they inspired @ % oxygen with the balance helium via mask and @-way valve , @-legged helium-hyperoxia ( @L-HH ) , or room air with supplemental oxygen via a nasal cannula , @-legged nitrogen-hyperoxia ( @L-NH ) .


We assessed quadriceps fatigue from the change in maximal voluntary contraction ( FMVC ) and transcutaneously stimulated twitch force ( Ftwitch ) .


Fifteen participants ( forced expiratory volume in @ second -LSB- SD -RSB- = @ -LSB- @ -RSB- % predicted ; forced expiratory volume in @ second/forced vital capacity = @ -LSB- @ -RSB- % ; peak oxygen uptake = @ -LSB- @ -RSB- mL kg min ) completed the study .


Self-reported `` leg fatigue '' was a reason for stopping @ of @ tests .


There was no significant difference in tlimit ( @ -LSB- -@ to @ -RSB- min ) between @L-HH ( @ -LSB- @ -RSB- min ) and @L-NH ( @ -LSB- @ -RSB- min ) , or in FMVC measured shortly after HH and NH tests ( P = @ ) .


The Ftwitch was less after exercise ( P < @ ) in both conditions , without a difference between conditions ( P = @ ) .


Inspiring a helium-hyperoxia mixture does not increase the endurance of what would be a typical training session , breathing supplemental oxygen , of high-intensity @-legged constant power exercise .


Leg muscle fatigue was similar after @-legged exercise with and without breathing the helium mixture .


Approaches to training biomedical scientists have created a talented research community .


However , they have failed to create a professional workforce that includes many racial and ethnic minorities and women in proportion to their representation in the population or in PhD training .


This is particularly true at the faculty level .


Explanations for the absence of diversity in faculty ranks can be found in social science theories that reveal processes by which individuals develop identities , experiences , and skills required to be seen as legitimate within the profession .


Using the social science theories of Communities of Practice , Social Cognitive Career Theory , identity formation , and cultural capital , we have developed and are testing a novel coaching-based model to address some of the limitations of previous diversity approaches .


This coaching intervention ( The Academy for Future Science Faculty ) includes annual in-person meetings of students and trained faculty Career Coaches , along with ongoing virtual coaching , group meetings and communication .


The model is being tested as a randomized controlled trial with two cohorts of biomedical PhD students from across the U.S. , one recruited at the start of their PhDs and one nearing completion .


Stratification into the experimental and control groups , and to coaching groups within the experimental arms , achieved equal numbers of students by race , ethnicity and gender to the extent possible .


A fundamental design element of the Academy is to teach and make visible the social science principles which highly influence scientific advancement , as well as acknowledging the extra challenges faced by underrepresented groups working to be seen as legitimate within the scientific communities .


The strategy being tested is based upon a novel application of the well-established principles of deploying highly skilled coaches , selected and trained for their ability to develop talents of others .


This coaching model is intended to be a complement , rather than a substitute , for traditional mentoring in biomedical research training , and is being tested as such .


To determine if @ weeks of periodized strength resistance training ( RT ) utilizing relatively short rest interval lengths ( RI ) in between sets ( SS ) would induce greater improvements in body composition and muscular performance , compared to the same RT program utilizing extended RI ( SL ) .


@ male volunteers ( SS : n = @ , @ @ years ; SL : n = @ , @ @ years ) were assigned to one of two strength RT groups , following @ weeks of periodized hypertrophic RT ( PHRT ) : strength RT with @-s RI ( SS ) or strength RT with @-min RI ( SL ) .


Prior to randomization , all @ study participants trained @ days/week , for @ weeks , targeting hypertrophy ; from week @ to week @ , SS and SL followed the same periodized strength RT program for @ weeks , with RI the only difference in their RT prescription .


Following PHRT , all study participants experienced increases in lean body mass ( LBM ) ( p < @ ) , upper and lower body strength ( p < @ ) , and dynamic power ( p < @ ) , as well as decreases in percentage body fat ( p < @ ) .


Across the @-week strength RT phase , SS experienced significantly greater increases in LBM ( p = @ ) , flat machine bench press @-RM ( p < @ ) , bilateral leg press @-RM ( p < @ ) , narrow/neutral grip lat pulldown ( p < @ ) , and Margaria stair-climbing power ( p < @ ) , compared to SL .


This study suggests @ weeks of periodized high-intensity strength RT with shortened RI induces significantly greater enhancements in body composition , muscular performance , and functional performance , compared to the same RT prescription with extended RI , in older men .


Applied professionals may optimize certain RT-induced adaptations , by incorporating shortened RI .


Coagulopathy associates with poor outcome in sepsis .


Mild induced hypothermia has been proposed as treatment in sepsis but it is not known whether this intervention worsens functional coagulopathy .


Interim analysis data from an ongoing randomized controlled trial ; The Cooling And Surviving Septic shock ( CASS ) study .


Patients suffering severe sepsis/septic shock are allocated to either mild induced hypothermia ( cooling to @-@C for @hours ) or control ( uncontrolled temperature ) .


NCT@ .


Thrombelastography ( TEG ) is performed three times during the first day after study enrollment in all patients .


Reaction time ( R ) , maximum amplitude ( MA ) and patients ' characteristics are here reported .


One hundred patients ( control n = @ and intervention n = @ ; male n = @ ; median age @years ) with complete TEG during follow-up were included .


At enrollment , @ % , @ % , and @ % had a hypocoagulable , normocoagulable , and hypercoagulable TEG clot strength ( MA ) , respectively .


In the hypothermia group , functional coagulopathy improved during the hypothermia phase , measured by R and MA , in patients with hypercoagulation as well as in patients with hypocoagulation ( correlation between R and initial R : rho = -@ , p < @ and correlation between MA and initial MA : rho = -@ , p = @ ) .


Similar results were not observed in the control group neither for R ( rho = -@ , p = @ ) nor MA ( rho = -@ , p = @ ) .


Mild induced hypothermia did seem to improve functional coagulopathy in septic patients .


This improvement of functional coagulopathy parameters during the hypothermia intervention persisted after rewarming .


Randomized trials are warranted to determine whether the positive effect on sepsis-related coagulopathy can be transformed to improved survival .


To assess the efficacy of anti-xerostomic topical medication ( urea @ % ) in patients with burning mouth syndrome ( BMS ) .


Thirty-eight subjects diagnosed with BMS according to the International Association for the Study of Pain guidelines were randomized to either placebo ( @ % sodium carboxymethylcellulose , @ % methyl paraben , and @ % glycerol in distilled water qsp @ g ) or treatment ( urea @ % ) to be applied to the oral cavity @-@ times per day for @ months .


The patients were evaluated before and after treatment with the following instruments : the EDOF-HC protocol ( Orofacial Pain Clinic - Hospital das Clnicas ) , a xerostomia questionnaire , and quantitative sensory testing .


There were no differences in salivary flow or gustative , olfactory , or sensory thresholds ( P > @ ) .


Fifteen ( @ % ) patients reported improvement with the treatments ( P = @ ) .


In conclusion , there were no differences between groups , and both exhibited an association between reported improvement and salivation .


To determine the level of agreement and potential impact on disease-modifying antirheumatic drug ( DMARD ) escalation decisions and of adding musculoskeletal ultrasound ( MSUS ) assessment of disease activity to the Disease Activity Score in @ joints ( DAS@ ) in early rheumatoid arthritis ( RA ) .


Data were gathered from @ early RA patients randomized to the MSUS assessment group of the Targeting Synovitis in Early Rheumatoid Arthritis study .


DAS@ scores were calculated every month .


MSUS was performed on patients with low disease activity ( DAS@ < @ ) and on those with moderate disease activity ( @ DAS@ < @ ) without clinically swollen joints ( swollen joint count -LSB- SJC -RSB- @ ) .


Fourteen joints ( bilateral proximal interphalangeal joints @ and @ , metacarpophalangeal -LSB- MCP -RSB- joints @ and @ , the radiocarpal , and metatarsophalangeal joints @ and @ ) were examined .


Active disease was defined as @ joints demonstrating any power Doppler ( PD ) signal .


Data from @ paired DAS@ and MSUS assessments were pooled to determine the level of agreement between each method .


A total of @ MSUS assessments were conducted on patients with DAS@ < @ ; @ ( @ % ) of these assessments identified active disease .


A total of @ MSUS assessments were performed on those with DAS@ < @ ; @ ( @ % ) of these identified active disease .


Forty-five MSUS assessments were conducted on patients with @ DAS@ < @ and SJC @ ; @ ( @ % ) of these assessments confirmed active disease .


On @ occasions ( @ % ) , MSUS findings contradicted the DAS@ and led to modified treatment decisions .


The joints that most frequently exhibited PD signal were radiocarpal and index and middle MCP joints .


Compared to the DAS@ , global RA disease activity assessment using a limited MSUS joint set provided additional disease activity information and led to altered treatment decisions in a significant minority of occasions .


This may allow further tailoring of DMARD therapy by supporting DMARD escalation in patients with continuing subclinical synovitis and preventing escalation in symptomatic patients with minimal clinical and/or ultrasonographic synovitis .


Breast density is an established predictor of breast cancer risk , and there is considerable interest in associations of modifiable lifestyle factors , such as diet , with breast density .


To determine whether dietary energy density ( ED ) is associated with percent dense breast volume ( % DBV ) and absolute dense breast volume ( ADBV ) in young women .


A cross-sectional analysis was conducted with women who participated in the Dietary Intervention Study in Children Follow-Up Study .


% DBV and ADBV were measured by magnetic resonance imaging .


Diet was assessed by three @-hour recalls .


Dietary ED ( kilocalories/gram ) was calculated using three methods : food only , food and caloric beverages , and food and all beverages .


One hundred seventy-two women ( aged @ to @ years ) who were enrolled in the Dietary Intervention Study in Children Follow-Up Study .


Participants who reported breast augmentation or reduction surgery or were pregnant or lactating within @ months before breast density assessment were excluded .


ADBV and % DBV .


Multivariable linear mixed effects models were used .


Final models were adjusted for race , smoking status , education , parity , duration of sex hormone use , whole body percent fat , childhood body mass index z score , and energy from beverages .


After adjustment , each @ kcal/g unit increase in food-only ED was associated with a @ % ( @ % CI @ % to @ % ) increase in % DBV ( P = @ ) .


Childhood body mass index z score modified the association between food-only ED and % DBV such that a significant positive association was observed only in women who were heavier as children .


Food-only ED was not associated with ADBV in all women , but a borderline significant positive association was observed in women who had higher childhood body mass index z scores .


This is the first report to suggest a potential role for dietary ED in breast density ; the effects of long-term exposure to high-ED diets on breast cancer risk remain unknown .


To our knowledge , there is no level @ evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus ( TASC II ) B and C superficial femoral artery lesions .


The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial ( ROBUST ) is the first prospective randomized clinical trial comparing both treatments .


To report the design of the ROBUST trial .


The primary aim of the trial is to compare ( @ ) the patency rate ( primary , primary assisted , and secondary patency at @ and @ months ) , ( @ ) improvement of quality of life , ( @ ) clinical improvement ( at least @ Rutherford category ) , and ( @ ) wound healing and limb salvage in patients presenting with critical limb ischemia ; secondary aims include ( @ ) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation , readmission , and reintervention costs , ( @ ) amputation-free survival , ( @ ) reintervention rate , and ( @ ) @-day operative mortality , morbidity , and wound and access complications .


ROBUST is a prospective randomized clinical trial with the aim to enroll @ patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia .


The maximum level of medical therapy will be administered using antiplatelet agents and statins , as well as measures to control hypertension and diabetes mellitus .


Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting ; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass , respectively .


All patients will be evaluated at @ , @ , and @ months postoperatively with physical examination , ankle brachial index , duplex , and a quality-of-life questionnaire .


The trial is actively enrolling participants .


At the time of writing , @ patients have been enrolled ; most are male ( @ % ) and white ( @ % ) .


Providing level @ evidence , ROBUST may help to establish guidelines for the treatment of superficial femoral artery lesions , eliminate unnecessary procedures , and reduce health care costs .


We evaluated the safety , tolerability , and pharmacokinetics ( PK ) of EMD @ ( DI@E@ ) , a humanized monoclonal antibody targeting v-integrins , in healthy subjects .


In this first-in-human , double-blind , placebo-controlled , randomized Phase @ study , healthy male volunteers were consecutively assigned to @ ascending single-dose cohorts of @ , @ , @ , @ , @ , or @ mg .


Per dose cohort , EMD @ or placebo was administered over @ h as an intravenous @-mL infusion to @ and @ volunteers , respectively .


Escalation to the next dose level was based on evaluation of safety , tolerability , and PK data .


Fifty-five subjects ( aged @-@ years ) were randomized .


Twenty-seven of @ ( @ % ) subjects receiving EMD @ reported a total of @ adverse events ( AEs ) , including @ events ( in @ subjects ) considered by the investigator to be treatment related .


A total of @ AEs were reported by @ of @ ( @ % ) placebo-treated subjects .


The most commonly occurring AEs were gastrointestinal disorders , abnormal laboratory values , and increased or decreased biochemistry and/or hematology values , as well as headaches , which occurred at a slightly higher frequency in the EMD @ group compared with placebo .


There were no serious AEs or deaths .


EMD @ PK appeared to be dose dependent , especially at lower doses .


Ascending single doses of EMD @ were shown to be safe and well tolerated .


No safety concerns were identified .


This study supports the ongoing investigation of EMD @ .


Erythromycin is a macrolide antibiotic , which is frequently used as a topical formulation for the treatment of acne .


It is also known as an inhibitor of the cytochrome P@ ( CYP ) isoenzyme @A@ .


In this study , the systemic availability of topical erythromycin , hence the influence on the activity of CYP@A , is evaluated in comparison to orally administered erythromycin .


Sixteen healthy volunteers received consecutively topical ( two applications of @mg ) and oral erythromycin ( two dose groups , @ and @mg , with n = @ ) to assess erythromycin pharmacokinetics .


A microdose of midazolam ( @g orally ) was used to determine the effect on CYP@A activity .


After topical administration , erythromycin was detected in the plasma of every participant without causing a statistically significant alteration of CYP@A activity .


After oral administration , the dose-normalized erythromycin exposure ( AUC ) was @hngml ( -@ ) after @mg and @-fold higher after the @mg dose ( @hngml ( -@ ) ; P < @ ) , suggesting nonlinear pharmacokinetics of erythromycin .


Both oral doses inhibited CYP@A activity ; midazolam clearance was decreased to @ % ( @mg ) and @ % ( @mg ) .


The relationship between erythromycin exposure and CYP@A activity ( Hill equation ) revealed a @ % reduction of CYP@A activity by an erythromycin AUC of @hngml ( -@ ) .


Topical erythromycin did not cause clinically relevant CYP@A alterations , although low systemic availability of erythromycin was observed .


This supports the assumption that treatment with topical erythromycin is not critical in terms of CYP@A inhibition .


Furthermore , substantial nonlinearity of erythromycin pharmacokinetics after two different oral doses was observed , possibly due to autoinhibition .


Socially disadvantaged men are at a substantially higher risk of developing alcohol-related problems .


The frequency of heavy drinking in a single session is high among disadvantaged men .


Brief alcohol interventions were developed for , and are usually delivered in , healthcare settings .


The group who binge drink most frequently , young to middle-aged disadvantaged men , have less contact with health services and there is a need for an alternative method of intervention delivery .


Text messaging has been used successfully to modify other adverse health behaviours .


This study will test whether text messages can reduce the frequency of binge drinking by disadvantaged men .


Disadvantaged men aged @ to @years who drank > @ units of alcohol at least twice in the preceding month will be recruited from the community .


Two recruitment strategies will be used : contacting men listed in primary care registers , and a community outreach method ( time-space sampling ) .


The intended sample of @ men will be randomised to intervention or control , stratifying by recruitment method .


The intervention group will receive a series of text messages designed to reduce the frequency of binge drinking through the formation of specific action plans .


The control group will receive behaviourally neutral text messages intended to promote retention in the study .


The primary outcome measure is the proportion of men consuming > @ units on at least three occasions in the previous @days .


Secondary outcomes include total alcohol consumption and the frequency of consuming more than @ units of alcohol in one session in the previous month .


Process measures , developed during a previous feasibility study , will monitor engagement with the key behaviour change components of the intervention .


The study will incorporate an economic evaluation comparing the costs of recruitment and intervention delivery with the benefits of reduced alcohol-related harm .


This study will assess the effectiveness of a brief intervention , delivered by text messages , aimed at reducing the frequency of binge drinking in disadvantaged men .


The process measures will identify components of the intervention which contribute to effectiveness .


The study will also determine whether any benefit of the intervention is justified by the costs of intervening .


Pediatricians underestimate the prevalence of substance misuse among children and adolescents and often fail to screen for and intervene in practice .


The American Academy of Pediatrics recommends training in Screening , Brief Intervention , and Referral to Treatment ( SBIRT ) , but training outcomes and skill acquisition are rarely assessed .


We compared the effects of online versus in-person SBIRT training on pediatrics residents ' knowledge , attitudes , behaviors , and skills .


Forty pediatrics residents were randomized to receive either online or in-person training .


Skills were assessed by pre - and posttraining standardized patient interviews that were coded for SBIRT-adherent and - nonadherent behaviors and global skills by @ trained coders .


Thirty-two residents also completed pre - and postsurveys of their substance use knowledge , attitudes , and behaviors ( KABs ) .


Two-way repeated measures multivariate analyses of variance ( MANOVAs ) and analyses of variance ( ANOVAs ) estimates were used to assess group differences in skill acquisition and KABs .


Findings indicated that both groups demonstrated skill improvement from pre - to postassessment .


Results indicated that both groups increased their knowledge , self-reported behaviors , confidence , and readiness with no significant between-group differences .


Follow-up univariate analyses indicated that , while both groups increased their SBIRT-adherent skills , the online training group displayed more `` undesirable '' behaviors posttraining .


The current study indicates that brief training , online or in-person , can increase pediatrics residents ' SBIRT skills , knowledge , self-reported behaviors , confidence , and readiness .


The findings further indicate that in-person training may have incremental benefit in teaching residents what not to do .


To investigate effects and functional mechanism of compound Congrongyizhi Capsule ( CCRC ) , a Chinese medicine , on cognitive functions against amnestic mild cognitive impairment ( aMCI ) patients with functional magnetic resonance imaging ( fMRI ) based on n-back task .


Forty-one aMCI participants from hospital and local communities in Beijing and randomly divided into treatment ( @ patients with CCRC capsule treatment ) , placebo ( @ patients with placebo capsules ) and control group ( @ patients with no treatment ) .


The duration of intervention lasted for @ months .


Neuropsychological tests and fMRI were applied to assess cognitive ability and brain activation changes after three months treatment .


Drug group ( n = @ ) presented increased significance in the MMSE ( P = @ ) and digit span ( P < @ ) tests , while other scores of neuropsychological tests showed no statistical significance .


fMRI results showed an increased brain negative activation in drug group during performing the n-back working-memory task in posterior cingulate ( PCC ) , inferior frontal gyrus and lingual gyrus regions after @ months ; placebo and control group did not show the same effect .


Meanwhile , there were negative correlations between left PCC activation levels and changed values of MMSE and digit span separately since increased negative activation was associated with better performance on the scores of MMSE and Digit Span tests .


CCRC can increase negative activation degree of PCC under performing working memory tasks while this modulation are associated with better performance on the MMSE and Digit Span .


@,@ hip and knee joint replacements are performed every year in the National Health Service ( NHS ) .


One of the commonest complications is surgical site infection ( SSI ) , and this represents a significant burden in terms of patient morbidity , mortality and cost to health services around the world .


The aim of this randomised controlled trial ( RCT ) is to determine if the addition of triclosan coated sutures to a standard regimen can reduce the rate of SSI after total knee replacement ( TKR ) and total hip replacement ( THR ) .


@ patients due to undergo a total hip or knee replacement are being recruited into this two-centre RCT .


Participants are recruited before surgery and randomised to either standard care or intervention group .


Participants , outcome assessors and statistician are blind to treatment allocation throughout the study .


The intervention consists of triclosan coated sutures vs. standard non-coated sutures .


The primary outcome is the Health protection Agency ( HPA ) defined superficial surgical site infection at @ days .


Secondary outcomes include HPA defined deep surgical site infection at @ months , length of hospital stay , critical care stay , and payer costs .


To date there are no orthopaedic randomised controlled trials on this scale assessing the effectiveness of a surgical intervention , particularly those that can be translated across the surgical specialities .


The results from this trial will inform evidence-based recommendations for suture selection in the management of patients undergoing total hip or knee replacement .


If triclosan coated sutures are found to be an effective intervention , implementation into clinical practice could improve long-term outcomes for patients undergoing hip and knee replacement .


Immunogenicity and safety of a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT were evaluated in the second year of life in HibMenCY-TT-primed toddlers .


Healthy infants were randomized ( @:@ ) and primed at @ , @ and @ months of age with HibMenCY-TT and diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus ( DTaP-HBV-IPV ) vaccine ; or Hib-TT and DTaP-HBV-IPV ( control ) .


Recipients of HibMenCY-TT + DTaP-HBV-IPV were re-randomized ( @:@:@ ) to receive MenACWY-TT at @-@ months and DTaP at @-@ months ; MenACWY-TT co-administered with DTaP at @-@ months ; or HibMenCY-TT at @-@ months and DTaP at @-@ months .


Controls received DTaP only at @-@ months due to Hib conjugate vaccine shortage .


Serum bactericidal activity using human complement ( hSBA ) and safety were assessed one month after meningococcal vaccination .


After vaccination with MenACWY-TT at @-@ months or MenACWY-TT + DTaP at @-@ months , all subjects previously primed for serogroups C/Y had hSBA @:@ for these serogroups .


At least @ % also had hSBA @:@ for serogroups A/W .


All subjects in the HibMenCY-TT group had hSBA @:@ for serogroups C/Y .


All pre-defined statistical criteria for meningococcal immunogenicity were satisfied .


All vaccination regimens had acceptable safety profiles .


Children primed with three doses of HibMenCY-TT who then received a single dose of MenACWY-TT or a fourth dose of HibMenCY-TT had robust increases in hSBA titers for serogroups C/Y .


These data provide support that MenACWY-TT , given with or without the fourth scheduled dose of DTaP could be administered as an alternative to a fourth dose of HibMenCY-TT in the second year of life .


This study ( @/@ ) is registered at www.clinicaltrials.gov NCT@ .


Duration of treatment for patients with vertebral osteomyelitis is mainly based on expert recommendation rather than evidence .


We aimed to establish whether @ weeks of antibiotic treatment is non-inferior to @ weeks in patients with pyogenic vertebral osteomyelitis .


In this open-label , non-inferiority , randomised controlled trial , we enrolled patients aged @ years or older with microbiologically confirmed pyogenic vertebral osteomyelitis and typical radiological features from @ medical care centres across France .


Patients were randomly assigned to either @ weeks or @ weeks of antibiotic treatment ( physician 's choice in accordance with French guidelines ) by a computer-generated randomisation list of permuted blocks , stratified by centre .


The primary endpoint was the proportion of patients who were classified as cured at @ year by a masked independent validation committee , analysed by intention to treat .


Non-inferiority would be declared if the proportion of cured patients assigned to @ weeks of treatment was not less than the proportion of cured patients assigned to @ weeks of treatment , within statistical variability , by an absolute margin of @ % .


This trial is registered with EudraCT , number @-@-@ , and Clinical Trials.gov , number NCT@ .


Between Nov @ , @ , and March @ , @ , @ patients were randomly assigned , of whom six in the @-week group and two in the @-week group were excluded after randomisation .


@ patients assigned to the @-week treatment regimen and @ to the @-week treatment regimen were analysed by intention to treat .


@ ( @ % ) of @ patients in the @-week group and @ ( @ % ) of @ of those in the @-week group met the criteria for clinical cure .


The difference between the groups ( @ % , @ % CI -@ to @ ) showed the non-inferiority of the @-week regimen when compared with the @-week regimen .


@ patients in the @-week group and @ in the @-week group had adverse events , the most common being death ( @ -LSB- @ % -RSB- in the @-week group vs @ -LSB- @ % -RSB- in the @-week group ) , antibiotic intolerance ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , cardiorespiratory failure ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) , and neurological complications ( @ -LSB- @ % -RSB- vs @ -LSB- @ % -RSB- ) .


@ weeks of antibiotic treatment is not inferior to @ weeks of antibiotic treatment with respect to the proportion of patients with pyogenic vertebral osteomyelitis cured at @ year , which suggests that the standard antibiotic treatment duration for patients with this disease could be reduced to @ weeks .


TNF - generates inflammatory responses and insulin resistance , lipolysis , and protein breakdown .


It is unclear whether these changes depend on intact hypothalamo-pituitary stress hormone responses to trigger the release of cortisol and growth hormone .


To define differential effects of TNF - on glucose , protein , and lipid metabolism in hypopituitary patients ( without intact hypothalamo-pituitary axis ) and healthy controls .


Randomized , placebo controlled , single-blinded .


Setting , Participants , and Intervention : We studied eight hypopituitary ( HP ) patients and eight matched control subjects -LSB- control volunteers ( CTR ) -RSB- twice during @-h basal and @-h hyperinsulinemic clamp conditions with isotope dilution during infusion of saline or TNF - ( @ ng/kg/h ) for @ h.


Phenylalanine , urea , palmitate , and glucose fluxes and fat biopsies in basal and clamp periods .


TNF - infusion significantly increased cortisol and GH levels in CTR but not in HP .


TNF - increased phenylalanine fluxes in both groups , with the increase being significantly greater in CTR , and raised urea flux by @ % in CTR without any alteration in HP .


Endogenous glucose production ( EGP ) was elevated in CTR compared to HP after TNF - administration , whereas insulin sensitivity remained similarly unaffected in both groups .


TNF - increased whole body palmitate fluxes and decreased palmitate specific activity in CTR , but not in HP without statistical difference between groups .


We did not detect significant effects TNF - on lipase expression or regulation in fat .


TNF - increased both urea and amino acid fluxes and EGP significantly more in CTR compared to HP , suggesting that increases in endogenous cortisol and GH release are significant components of the metabolic response to TNF - .


The root bark of Aralia is a rich source of bioactive components that may improve glycemic control and lipid status .


In this study , @ patients with type @ diabetes mellitus ( T@DM ) were assigned randomly to receive either glipizide alone or glipizide plus Aralia root bark extract ( ARBE ) for @ weeks to test the effects of ARBE plus glipizide therapy on glycemic control and lipid profiles in these patients .


Levels of HbA@c , fasting plasma glucose ( FPG ) and @ h postprandial plasma glucose ( @-h PPG ) in both groups significantly decreased from baseline .


Glycated hemoglobin ( HbA@c ) decreased marginally significantly in participants taking glipizide plus ARBE compared with the glipizide group ( P = @ ) .


Participants in the combination group had significant decreases in total cholesterol ( TC ) and low-density lipoprotein cholesterol ( LDL-C ) , and the between-group difference achieved statistical significance for LDL-C ( P = @ ) .


Reduction in HbA@c in the combination group was significantly associated with changes in TC ( r = @ ; P = @ ) and LDL-C ( r = @ ; P = @ ) , and the change in FPG was inversely correlated with LDL-C reduction ( r = @ ; P = @ ) .


In patients with T@DM , combination therapy with glipizide and ARBE resulted in moderately lowering HbA@c and LDL-C levels compared with glipizide alone .


To evaluate the velocity of canine retraction , anchorage loss and changes on canine and first molar inclinations using self-ligating and conventional brackets .


Twenty-five adults with Class I malocclusion and a treatment plan involving extractions of four first premolars were selected for this randomized split-mouth control trial .


Patients had either conventional or self-ligating brackets bonded to maxillary canines randomly .


Retraction was accomplished using @-g nickel-titanium closed coil springs , which were reactivated every @ weeks .


Oblique radiographs were taken before and after canine retraction was completed , and the cephalograms were superimposed on stable structures of the maxilla .


Cephalometric points were digitized twice by a blinded operator for error control , and the following landmarks were collected : canine cusp and apex horizontal changes , molar cusp and apex horizontal changes , and angulation changes in canines and molars .


The blinded data , which were normally distributed , were analyzed through paired t-tests for group differences .


No differences were found between the two groups for all variables tested .


Both brackets showed the same velocity of canine retraction and loss of anteroposterior anchorage of the molars .


No changes were found between brackets regarding the inclination of canines and first molars .


Tacrolimus is an established immunosuppressant used for the prevention and treatment of allograft rejection in solid organ transplantation .


An immediate-release oral formulation of tacrolimus has been commercially available since @ that is administered orally BID .


To improve the compliance and quality of life of transplant patients , a once-daily modified release ( MR ) formulation is an attractive option .


However , to be successful , the drug of interest must be sufficiently well absorbed from the distal region of the gastrointestinal tract .


To facilitate the development of an MR formulation , we investigated the absorption of tacrolimus from different regions of the human gastrointestinal tract , proximal and distal small bowels , and ascending colon .


The study was performed as an open-label , randomized , @-way crossover design in @ healthy white male subjects .


For each subject , @ mg ( @ mg/mL ) of tacrolimus solution in polyethylene glycol @ was administered to each location in the gastrointestinal tract via a site-specific radiolabeled delivery capsule , which can release tacrolimus solution at specific sites of the gastrointestinal tract .


Real-time visualization of capsule location and tacrolimus release at each target site was performed by using - scintigraphy .


Blood samples were collected to determine tacrolimus levels in the blood .


The pharmacokinetic parameters Cmax , Tmax after the capsule activation , AUC@-@ , and mean residence time were determined from the concentration-time profiles .


Ten healthy male subjects underwent dosing .


Six subjects completed all @ treatments .


Three adverse events ( mild headache -LSB- n = @ -RSB- , small amount of blood in stool -LSB- n = @ -RSB- , and mild syncopal episode -LSB- n = @ -RSB- ) that were possibly study drug related were reported in @ different subjects .


Tacrolimus was absorbed from not only the small intestine but also from the colonic region of the gastrointestinal tract .


Although AUC@-@ values revealed some site-specific absorption tendencies , the mean AUC@-@ values obtained were similar regardless of the location of tacrolimus release from the capsule .


Tacrolimus was absorbed from the duodenum to the colon in these male subjects , although differences were observed in the value of AUC@-@ , possibly due to variation in cytochrome P@ @A@ activity in the intestine .


Although this study was conducted in small group of healthy fasting men , the present results indicate that tacrolimus is suitable for MR formulation development due to a wide absorption window throughout the intestine in humans .


Roughly one third of disability pensions in Norway are issued for mental and behavioral disorders , and vocational rehabilitation offered to this group has traditionally been dominated by train-and-place approaches with assisted or sheltered employment .


Based on a more innovative place-and-train approach , Individual Placement and Support ( IPS ) involves supported employment in real-life competitive work settings , and has shown great promise for patients with severe mental illness .


The study is a multicenter Randomized Controlled Trial ( RCT ) of IPS in a Norwegian context , involving an effect evaluation , a process evaluation , and a cost/benefit analysis .


IPS will be compared to high quality treatment as usual ( TAU ) , with labor market participation and educational activity at @ months post inclusion as the primary outcome .


The primary outcome will be measured using register data , and the project will also include complete follow-up up to @ years after inclusion for long-term outcome data .


Secondary outcomes include mental health status , disability and quality of life , collected through survey questionnaires at baseline , and after @ and @ months .


Participants will include patients undergoing treatment for moderate to severe mental illness who are either unemployed or on sickness or social benefits .


The estimated total sample size of @-@ will be randomly assigned to the interventions .


To be eligible , participants must have an expressed desire to work , and sufficient Norwegian reading and writing skills to fill out the questionnaires .


The Effect Evaluation of Individual Placement and Support ( IPS ) will be one of the largest randomized controlled trials to date investigating the effectiveness of IPS on competitive employment , and the first study to evaluate the effectiveness of IPS for patients with moderate to severe mental illness within a Norwegian context .


Induction immunosuppression with anti-thymocyte globulin ( ATG ) provides potential benefits after liver transplantation ( LT ) .


However , its use in patients with LT and hepatitis C ( HCV ) is controversial .


To evaluate the @ - and @-year patient survival and HCV recurrence rate in patients receiving ATG during the induction phase of immunosuppression ( IPI ) after LT.


A total of @ patients undergoing their first LT for HCV were randomized to receive ATG during IPI .


Patient survival and HCV recurrence were determined at @ and @years .


The frequency of acute cellular rejection ( ACR ) , infections , and neoplasms was also evaluated .


Twenty-six patients were randomized to receive ATG ( Arm-@ ) and @ to standard induction therapy ( Arm-@ ) .


Those given ATG had lower HCV recurrence ( @ vs @ % , p = @ ) .


The @ - and @-year patient survival rates were similar for both arms ( p = @ ) .


Infections occurred in @ % subjects in Arm-@ and @ % in Arm-@ ( p = @ ) .


There was a greater proportion of fungal infections in Arm-@ ( @ vs @ % , p = @ ) .


ATG during the IPI was associated with lower frequency of recurrence of HCV in patients undergoing LT. This , however , did not affect the @ - and @-year survival and the frequency of ACR , infections , or neoplasms .


To compare the safety and effectiveness of small particle hyaluronic acid plus lidocaine ( SPHAL ) versus no treatment for lip augmentation and perioral rhytides .


Adults scoring @ ( very thin ) to @ ( thin ) on the Medicis Lip Fullness Scale ( MLFS ) for upper and lower lips were randomized ( @:@ ) to SPHAL or no treatment .


Treatment success was an MLFS increase @ point at Week @ .


Secondary end points ( MLFS score , independent photographic review , Global Aesthetic Improvement Scale , Wrinkle Assessment Scale for Upper Lip Lines ) and safety were assessed throughout .


Statistically significantly more patients were treatment successes with SPHAL ( upper lip -LSB- @ % vs @ % -RSB- , lower lip -LSB- @ % vs @ % -RSB- , and upper and lower lips combined -LSB- @ % vs @ % -RSB- ) , compared with no treatment ( p < @ , all outcomes ) .


Patients treated for both lip augmentation and perioral rhytides were rated as having an aesthetically meaningful improvement in perioral rhytides ( p < @ ) .


Most common treatment-emergent adverse events ( AEs ) included lip bruising , swelling , and pain and were mostly mild and transient in nature , without anticipated device AEs .


Small particle hyaluronic acid plus lidocaine was effective and well tolerated and significantly more effective when both lips and perioral rhytides were treated , with improvement evident up to @ months after treatment .


ABT-@ is a highly potent histamine-@ receptor antagonist that has demonstrated pro-cognitive effects in preclinical models relevant to schizophrenia .


This study evaluated the efficacy and safety of two doses of ABT-@ in the treatment of cognitive impairment associated with schizophrenia .


A randomized , double-blind , placebo-controlled , parallel-group @-week study was conducted at @ centers in the United States .


Clinically stable subjects with schizophrenia were randomized in an equal ratio to ABT-@ @ mg , ABT-@ @ mg , or placebo once daily while continuing their antipsychotic regimen .


The primary efficacy measure was the change from baseline to day @ evaluation on the Measurement and Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery ( MCCB ) composite score vs placebo .


Secondary measures included cognitive functioning and psychiatric scales .


Safety assessments and sparse pharmacokinetic sampling were also conducted .


A total of @ subjects were randomized .


The mean baseline MCCB composite score was @ .


Approximately @ % of subjects completed the study .


The MCCB composite score mean change from baseline to day @ was numerically worse for both the @ mg ( @ , P = @ ) and @ mg ( @ , P = @ ) doses of ABT-@ vs placebo ( @ ) .


Results from the secondary measures were consistent with the primary analysis .


Subjects ' schizophrenia symptoms remained stable throughout the study as evidenced by stable Positive and Negative Syndrome Scale scores .


Overall , study medication was tolerated ; however , an increased incidence of psychosis-related and sleep-related adverse events was associated with ABT-@ .


Neither dose of ABT-@ resulted in cognitive improvement in clinically stable adults with schizophrenia .


Aromatase inhibitors prevent breast cancer in postmenopausal women at high risk of the disease but are associated with accelerated bone loss .


We assessed effectiveness of oral risedronate for prevention of reduction in bone mineral density ( BMD ) after @ years of follow-up in a subset of patients in the IBIS-II trial .


The double-blind IBIS-II trial recruited @ healthy , postmenopausal women at increased risk of breast cancer and randomly allocated them oral anastrozole ( @ mg/day ) or matched placebo .


@ ( @ % ) postmenopausal women were then enrolled in a bone substudy and stratified at baseline according to their lowest baseline T score at spine or femoral neck ( stratum I : T score at least -@ ; stratum II : T score at least -@ but less than -@ ; stratum III : T score less than -@ but greater than -@ ) .


Women in stratum I were monitored only ; women in stratum III were all given risedronate ( @ mg/week ) .


Women in stratum II were randomly assigned ( @:@ ) to risedronate ( @ mg/week ) or matched placebo by use of a block randomisation schedule via a web-based programme .


The primary outcome of this per-protocol analysis ( done with all women with a baseline and @ year DXA assessment ) was the effect of risedronate versus placebo for osteopenic women in stratum II randomly allocated to anastrozole ( @ mg/day ) .


Secondary outcomes included effect of anastrozole ( @ mg/day ) on BMD in women not receiving risedronate ( strata I and II ) and in osteoporotic women who were all treated with risedronate ( stratum III ) .


The trial is ongoing , but no longer recruiting .


This trial is registered , number ISRCTN@ .


Between Feb @ , @ , and Sept @ , @ , @ ( @ % ) of @ women in stratum II who had been randomly allocated to anastrozole and either risedronate or placebo had baseline and @ year assessments .


At the lumbar spine , @ year mean BMD change for the @ women receiving anastrozole/risedronate was @ % ( @ % CI @ to @ ) versus -@ % ( -@ to -@ ) for the @ women receiving anastrozole/placebo ( p < @ ) .


For the total hip , @ year mean BMD change for women receiving anastrozole/risedronate was -@ % ( -@ to @ ) versus -@ % ( -@ to -@ ) for women receiving anastrozole/placebo ( p = @ ) .


@ ( @ % ) of @ women in strata I and II who were not randomly allocated to risedronate had both baseline and @ year assessments .


Women not receiving risedronate in stratum I and II who received anastrozole ( @ women ) had a significant BMD decrease after @ years of follow-up compared with women who received placebo ( @ women ) at the lumbar spine ( -@ % -LSB- -@ to -@ -RSB- vs -@ % -LSB- -@ to -@ -RSB- , p < @ ) and total hip ( -@ % -LSB- -@ to -@ -RSB- vs -@ % -LSB- -@ to -@ -RSB- , p < @ ) .


@ ( @ % ) of @ women in stratum III had a baseline and a @ year assessment .


The @ women allocated to anastrozole had a modest BMD increase of @ % ( -@ to @ ) at the spine compared with a @ % ( @ to @ ) increase for the @ women allocated to placebo ( p = @ ) .


For the total hip , a small @ % ( -@ to @ ) increase was noted for women allocated anastrozole compared with a @ % ( @ to @ ) increase for women allocated placebo , but the difference was not significant ( p = @ ) .


The most common adverse event reported was arthralgia ( stratum I : @ placebo and @ anastrozole ; stratum II : @ placebo/placebo , @ placebo/risedronate , @ anastrozole/placebo , and @ anastrozole/risedronate ; stratum III : @ placebo/risedronate , @ anastrozole/risedronate ) .


Other adverse events included hot flushes , alopecia , abdominal pain , and back pain .


Risedronate counterbalances the effect of anastrozole-induced bone loss in osteopenic and osteoporotic women and might be offered in combination with anastrozole treatment to provide an improved risk-benefit profile .


Exercise and diet are the cornerstones for the treatment of obesity in obese children and adolescents .


However , compensatory changes in appetite and energy expenditure elicited by exercise and dieting make it hard to maintain a reduced weight over the longterm .


The anorexic effect of hypoxia can be potentially utilized to counteract this compensatory increase , thereby enhancing the success of weight loss .


The purpose of the study is to assess the effectiveness of four week intermittent hypoxia exposure added to a traditional exercise and diet intervention on inducing short - and longterm weight loss in obese adolescents .


In this randomized parallel group controlled clinical trial , @ obese adolescents ( @ boys and @ girls , @ to @-years-old ) , will be recruited from a summer weight loss camp at the Shanghai University of Sport , China .


Participants will be stratified by gender and randomly assigned to either the control group or the hypoxia group .


During the four-week intervention period , both groups will exercise and eat a balanced diet .


Additionally , the control group will sleep in normal conditions , while the hypoxia group will sleep in a normobaric hypoxia chamber ( sleep high and train low ) .


The primary outcome will be body composition and the main secondary outcomes will be the circulating levels of appetite regulatory gastrointestinal hormones .


All the outcome measures will be assessed at baseline , after the four-week intervention , and at two months follow-up .


Our study will be the first to evaluate the effectiveness of ` sleep high and train low ' on short - and longterm weight loss among obese adolescents .


A potential mechanism for the appetite regulatory effect of hypoxia will also be explored .


The results of the study will provide an evidence-based recommendation for the use of hypoxia in a weight loss intervention among obese children and adolescents .


Furthermore , the clarification of mechanisms leading to weight loss in ` sleep high and train low ' might provide information for the development of new strategies in combating obesity .


Periprocedural myocardial injury ( PMI ) following percutaneous coronary intervention ( PCI ) has received great attention due to its significant association with mortality and morbidity .


Accordingly , cardioprotection during PCI is one of the important therapeutic concerns .


Regarding the potential cardiovascular benefits of pentoxifylline this study was performed to evaluate whether the pretreatment pentoxifylline could reduce PMI in patients who are undergoing elective PCI .


A randomized clinical trial on @ patients undergoing elective PCI was performed .


The intervention group ( n = @ ) received @ mg pentoxifylline in divided doses plus the standard treatment before PCI , while the control group ( n = @ ) received the standard treatment .


For assessing myocardial damage during PCI , the levels of CK-MB and troponin-I were measured at baseline , @ , and @ h after the procedure .


Then , patients were followed up for a @-month period regarding the major adverse cardiac effect .


Comparing with the control group , no significant change of CK-MB at @ ( p = @ ) and @ h ( p = @ ) after PCI was documented in pentoxifylline group .


Similarly , no significant change was found in troponin-I at @ ( p = @ ) and @ h ( p = @ ) after PCI .


This study could not support the pretreatment with pentoxifylline in the prevention of PMI in patients undergoing elective PCI .


However , the trend was toward the potential benefit of pentoxifylline .


Hospital admissions for acute decompensated heart failure ( ADHF ) are frequent and are accompanied by high percentages of mortality and readmissions .


Brain natriuretic peptide ( BNP ) and the inactive N-terminal fragment of its precursor proBNP ( NT-proBNP ) are currently the best predictors of prognosis in heart failure ( HF ) patients .


In the setting of chronic HF , studies that performed guidance of therapy by NT-proBNP have had only limited success .


For patients with ADHF , retrospective studies have shown that a reduction in NT-proBNP of @ % during admission is a significant predictor of HF readmissions and mortality .


These data suggest a role for NT-proBNP guidance in the setting of ADHF admissions .


The PRIMA II is an investigator-initiated , multicenter , randomized , controlled , prospective @-arm trial that investigates the impact of inhospital guidance for ADHF treatment by a predefined NT-proBNP target ( > @ % reduction during admission ) on the reduction of readmission and mortality rates within @ days .


Consenting ADHF patients with NT-proBNP levels of > @,@ ng/L are eligible .


After achieving clinical stability , a total of @ patients are randomized to either NT-proBNP-guided or conventional treatment ( @:@ ) .


The primary end point is dual , that is , a composite of all-cause mortality and readmission for HF in @ days and the number of days alive out of hospital in @ days .


Secondary end points are readmissions and/or mortality in @ days , cost effectiveness of hospitalization days in @ days , readmissions and mortality in @ days , and quality of life .


The PRIMA II trial aims at providing scientific evidence for the use of NT-proBNP-guided therapy compared with conventional treatment in patients admitted for ADHF .


We aimed to examine the effects of topical hypothermia on inflammatory markers in patients undergoing coronary artery bypass surgery .


Fifty patients undergoing isolated coronary artery bypass surgery were included the study .


They were randomised to two groups .


Mild hypothermic cardiopulmonary bypass ( @-@C ) was performed on both groups using standardised anaesthesiology and surgical techniques .


Furthermore , topical cooling with @C saline was performed on patients in group I.


We recorded peri-operative and intra-operative results of blood samples , pre-operative and postoperative outcomes of electrocardiography and echocardiography , diaphragm levels on X-ray , and the necessity of positive inotropic medication and intra-aortic balloon pump ( IABP ) .


Time-dependent changes in blood samples were compared between the two groups .


The changes on complement @ ( C@ ) and TNF - levels were more significant in group I than group II ( p < @ and p < @ , respectively ) .


Spontaneous restoration rate of sinus rhythm was higher in group II than group I ( @ vs @ % , p < @ ) .


Atrial fibrillation was seen in six patients in group I and one patient in group II ( p < @ ) .


IABP was performed on four patients ( @ % ) in group I ( p < @ ) .


Diaphragmatic paralysis was seen in seven patients in group I but not in group II ( p < @ ) .


Partial pericardiotomy rates were compared within the groups but there was no statistically significant difference ( p > @ ) .


One patient in group I died on the @th postoperative day , but operative mortality rate was not statistically significant between the two groups ( p > @ ) .


Topical hypothermia had a negative impact on inflammatory markers and postoperative morbidities .


Bedaquiline ( Sirturo , TMC@ ) , a diarylquinoline that inhibits mycobacterial ATP synthase , has been associated with accelerated sputum-culture conversion in patients with multidrug-resistant tuberculosis , when added to a preferred background regimen for @ weeks .


In this phase @b trial , we randomly assigned @ patients with newly diagnosed , smear-positive , multidrug-resistant tuberculosis to receive either @ mg of bedaquiline once daily for @ weeks , followed by @ mg three times a week for @ weeks , or placebo , both in combination with a preferred background regimen .


The primary efficacy end point was the time to sputum-culture conversion in liquid broth .


Patients were followed for @ weeks from baseline .


Bedaquiline reduced the median time to culture conversion , as compared with placebo , from @ days to @ days ( hazard ratio in the bedaquiline group , @ ; @ % confidence interval , @ to @ ; P < @ by Cox regression analysis ) and increased the rate of culture conversion at @ weeks ( @ % vs. @ % , P = @ ) and at @ weeks ( @ % vs. @ % , P = @ ) .


On the basis of World Health Organization outcome definitions for multidrug-resistant tuberculosis , cure rates at @ weeks were @ % in the bedaquiline group and @ % in the placebo group ( P = @ ) .


The overall incidence of adverse events was similar in the two groups .


There were @ deaths in the bedaquiline group and @ in the placebo group , with no causal pattern evident .


The addition of bedaquiline to a preferred background regimen for @ weeks resulted in faster culture conversion and significantly more culture conversions at @ weeks , as compared with placebo .


There were more deaths in the bedaquiline group than in the placebo group .


( Funded by Janssen Pharmaceuticals ; TMC@-C@ ClinicalTrials.gov number , NCT@ . )


The conventional sequence when using supraglottic airway devices is insertion , cuff inflation and fixation .


Our hypothesis was that a tighter fit of the cuff and tip could be achieved with a consequently lower incidence of air leak , better separation of gastrointestinal and respiratory tracts and less airway morbidity if the device were first affixed and the cuff then inflated .


Our clinical review board approved the study ( public registry number DRKS@ ) .


An LMA Supreme was inserted into @ patients undergoing lower limb arthroscopy in propofol-remifentanil anaesthesia who were randomly assigned to either the control ( inflation then fixation ; n = @ ) or study group ( fixation then inflation ; n = @ ) .


The cuff was inflated to @ cmH@O .


The patients ' lungs were ventilated in pressure-controlled mode with @ cmH@O PEEP , Pmax to give @mlkg-@ tidal volume , and respiratory rate adjusted to end-tidal CO@ of @ and @ kPa .


Correct cuff and tip position were determined by leak detection , capnometry trace , oropharyngeal leak pressure , suprasternal notch test , and lube-tube test .


Bowl and cuff position and the presence of glottic narrowing were assessed by fiberscopic examination .


Postoperative dysphagia , hoarseness and sore throat were assessed with a questionnaire .


Ventilatory impairment was defined as a tidal volume < @mlkg-@ with Pmax at oropharyngeal leak pressure , glottic narrowing was defined as an angle between the vocal cords under @ degrees .


The incidence of incorrect device position ( @ % vs. @ % ) , failed ventilation ( @ % vs. @ % ) , leak pressure ( @ vs. @ cmH@O , p = @ ) , failed lube-tube test ( @ % vs. @ % ) and glottic narrowing ( @ % vs. @ % , p = @ ) was similar in both groups ( control vs. study , resp . )


When glottic narrowing occurred , it was more frequently associated with ventilatory impairment in the control group ( @ % vs. @ % ; p = @ ) .


Airway morbidity was more common in the control group ( @ % vs. @ % ; p < @ ) .


Altering the sequence of cuff inflation and device fixation does not affect device position , oropharyngeal leak pressures or separation of gastrointestinal and respiratory tracts .


It reduces the incidence of glottic narrowing with impaired ventilation and also perioperative airway morbidity .


A prophylactic human papillomavirus ( HPV ) vaccine targeting oncogenic HPV types in addition to HPV-@ and -@ may broaden protection against cervical cancer .


Two Phase I/II , randomized , controlled studies were conducted to compare the immunogenicity and safety of investigational tetravalent HPV L@ virus-like particle ( VLP ) vaccines , containing VLPs from two additional oncogenic genotypes , with the licensed HPV-@ / @ AS@-adjuvanted vaccine ( control ) in healthy @-@ year-old women .


In one trial ( NCT@ ) , subjects received control or one of @ tetravalent HPV-@ / @/@/@ AS@ vaccine formulations at months ( M ) @,@,@ .


In a second trial ( NCT@ ) , subjects received control or one of @ tetravalent HPV-@ / @/@/@ vaccines formulated with different adjuvant systems ( AS@ , AS@ or AS@ ) , administered on different schedules ( M@ ,@,@ or M@ ,@ or M@ ,@ ) .


One month after the third injection ( Month @ ) , there was a consistent trend for lower anti-HPV-@ and -@ geometric mean antibody titers ( GMTs ) for tetravalent AS@-adjuvanted vaccines compared with control .


GMTs were statistically significantly lower for an HPV-@ / @/@/@ AS@ vaccine containing @/@/@ / @ g VLPs for both anti-HPV-@ and anti-HPV-@ antibodies , and for an HPV-@ / @/@/@ AS@ vaccine containing @/@/@ / @ g VLPs for anti-HPV-@ antibodies .


There was also a trend for lower HPV-@ and -@ - specific memory B-cell responses for tetravalent AS@ vaccines versus control .


No such trends were observed for CD@ ( + ) T-cell responses .


Immune interference could not always be overcome by increasing the dose of HPV-@ / @ L@ VLPs or by using a different adjuvant system .


All formulations had acceptable reactogenicity and safety profiles .


Reactogenicity in the @-day post-vaccination period tended to increase with the introduction of additional VLPs , especially for formulations containing AS@ .


HPV-@ and -@ antibody responses were lower when additional HPV L@ VLPs were added to the HPV-@ / @ AS@-adjuvanted vaccine .


Immune interference is a complex phenomenon that can not always be overcome by changing the antigen dose or adjuvant system .


In a multicenter , double-blind , randomized , parallel-group , placebo-controlled , single-dose study ( n = @ ) , a fixed combination of acetaminophen @mg , acetylsalicylic acid @mg , and caffeine @mg ( AAC ) was compared with ibuprofen @mg ( IB ) and placebo ( PLA ) for acute treatment of migraine .


An exploratory post-hoc analysis compared AAC with IB and PLA in the subset of patients with severe pain at baseline ( n = @ ) .


At most time points , AAC and IB relieved the pain and associated symptoms of severe migraine significantly better than PLA ( p@ @ ) .


AAC was significantly superior to IB for pain relief at @ minutes and at one , two , three , and four hours postdose ( p < @ ) ; pain intensity difference from one hour through three hours ( p < @ ) ; headache response at two hours ( p = @ ) ; functional disability reduced to little or none at three hours ( p = @ ) ; freedom from phonophobia at three hours ( p = @ ) and photophobia at @ minutes postdose ( p = @ ) ; and use of rescue medication ( p = @ ) .


AAC patients also reported meaningful pain relief @ minutes faster than IB patients ( @ minutes vs @ minutes , p = @ ) .


In patients with severe baseline migraine pain , AAC and IB are significantly more effective than PLA , and AAC provides significantly faster and more effective pain relief than IB .


Determine whether MRI activity @ months after treatment initiation in the Controlled High-Risk Subjects Avonex Multiple Sclerosis Prevention Study ( CHAMPS ) predicted progression to clinically definite multiple sclerosis ( CDMS ) over the subsequent @ months in intramuscular interferon beta-@a ( IM IFN-@a ) - treated patients vs placebo-treated patients .


CHAMPS patients were randomized to once-weekly IM IFN-@a @ g or placebo for up to @ months .


MRI was performed every @ months until CDMS confirmation .


Patient groups were defined based on new T@ and/or Gd + lesions at @ months .


Thirteen IM IFN-@a patients ( @ % ) and @ placebo patients ( @ % ) developed CDMS prior to month @ and did not undergo the @-month MRI .


At @ months , @ % of IM IFN-@a-treated patients vs @ % of placebo-treated patients were defined as having high MRI activity levels ( @ new T@ and/or @ Gd + lesions ) .


In this subgroup , estimated cumulative probabilities of CDMS were similar between groups ( HR = @ -LSB- @-@ @ -RSB- , p = @ ) .


A significant treatment response was seen for patients with < @ new T@ and < @ Gd + lesions at @ months ( HR = @ -LSB- @-@ @ -RSB- , p = @ ) .


MRI scans @ months after IM IFN-@a initiation in CIS patients predict early treatment non-response .


Standardized scanning and monitoring may facilitate early disease management .


Blood loss and blood substitution are associated with higher morbidity after major abdominal surgery .


During major liver resection low local venous pressure decreases blood loss .


Ambiguity persists concerning the impact of local venous pressure on blood loss during open radical cystectomy .


We determined the association between intraoperative blood loss and pelvic venous pressure as well as factors affecting pelvic venous pressure .


In this single center , double-blind , randomized trial pelvic venous pressure was measured in @ patients in a norepinephrine-low volume group and in @ controls with liberal hydration .


As secondary analysis patients from each arm were stratified into subgroups with pelvic venous pressure less than @ mm Hg , or @ or greater as measured after cystectomy , which is the optimal cutoff for identifying patients with relevant blood loss according to the Youden index .


Median blood loss was @ ml ( range @ to @,@ ) in @ of @ patients ( @ % ) with pelvic venous pressure less than @ mm Hg and @,@ ml ( range @ to @,@ ) in @ of @ ( @ % ) with pelvic venous pressure @ mm Hg or greater ( p < @ ) .


Pelvic venous pressure less than @ mm Hg was measured in @ of @ patients ( @ % ) in the norepinephrine-low volume group and in @ of @ controls ( @ % ) ( p < @ ) .


Pelvic venous pressure decreased significantly after removing abdominal packing and abdominal lifting in each group at all time points , that is at the beginning and end of pelvic lymph node dissection , and the end of cystectomy ( p < @ ) .


No correlation was detected between pelvic venous pressure and central venous pressure .


Blood loss was significantly decreased in patients with low pelvic venous pressure .


Factors affecting pelvic venous pressure were fluid management and abdominal packing .


Survivors of breast cancer may experience deterioration of physical function .


This is important because poor physical function may be associated with premature mortality , injurious falls , bone fracture , and disability .


We conducted a post hoc analysis to explore the potential efficacy of slowly progressive weight lifting to reduce the incidence of physical function deterioration among survivors of breast cancer .


Between October @ and August @ , we conducted a single-blind , @-month , randomized controlled trial of twice-per-week slowly progressive weight lifting or standard care among @ survivors of nonmetastatic breast cancer .


In this post hoc analysis of data from the Physical Activity and Lymphedema Trial , we examined incident deterioration of physical function after @ months , defined as a @-point decrease in the physical function subscale of the Medical Outcomes Short-Form @-item questionnaire .


The proportion of participants who experienced incident physical function deterioration after @ months was @ % ( @/@ ) in the control group and @ % ( @/@ ) in the weight lifting group ( relative risk , @ ; @ % CI , @ to @ ; P = @ ) .


No serious or unexpected adverse events occurred that were related to weight lifting .


Slowly progressive weight lifting compared with standard care reduced the incidence of physical function deterioration among survivors of breast cancer .


These data are hypothesis generating .


Future studies should directly compare the efficacy of weight lifting with other modalities of exercise , such as brisk walking , to appropriately inform the development of a confirmatory study designed to preserve physical function among survivors of breast cancer .


To evaluate the effect of intracameral lidocaine anesthesia on macular thickness and macular ganglion cell-inner plexiform layer ( GC-IPL ) thickness following uneventful phacoemusification in healthy subjects .


This is a prospective , randomized and double - masked study .


One hundred eyes of @ consecutive patients were randomized to receive intracameral preservative-free lidocaine @ % ( intracameral lidocaine group ) or intracameral injection of balanced salt solution ( sham injection group ) at the time of the phacoemulsification surgery .


Preoperative and postoperative macular thickness analyses with spectral domain optical coherence tomography ( SD-ODT ) were performed and the results between the two groups were compared .


Postoperatively , both the central foveal thickness ( CFT ) and the thickness of perifoveal macula were significantly improved in both groups ( p < @ ) .


There was no statistically significant difference between CFT and the inner and outer macular zone thicknesses of the two groups at any follow-up time .


In both groups , GC-IPL thickness was significantly increased at the first week and first month visits ( p < @ ) .


There was no statistically significant difference between GC-IPL thickness measurements of the two groups at any follow-up time .


The current study demonstrated that supplementary intracameral lidocaine @ % did not cause more macular thickening than the intracameral sham injection during a follow-up period of @months .


The present study also showed a tendency for a transient increase in high definition SD-OCT-based GC-IPL thickness measurements within a few months following cataract surgery under both intracameral lidocaine anesthesia and intracameral sham injection .


In the current analysis due to the mechanism of effect , we evaluated the treatment benefit of duloxetine @ mg comparing with paroxetine @ mg , based on its effects on personal distress and interpersonal difficulty related to ejaculation , perceived control over ejaculation , and satisfaction with sexual intercourse , as well as the patient-reported global impression of change in premature ejaculation ( PE ) and the effect on intravaginal ejaculatory latency times ( IELT ) in men with premature ejaculation .


The study included @ married male patients diagnosed with lifelong PE .


A total of @ patients were randomly distributed into two groups of @ patients each .


Group @ patients received @ mg duloxetine once a day for a month .


Group @ patients received @ mg paroxetine once a day for a month .


International index of erectile function questionnaire ( IIEF ) and IELT and PE profile were recorded before and after treatment .


Comparing the groups ' mean treatment IELT , there was no difference between groups .


The IELT increase from baseline to treatment was @ % in the duloxetine group ( P < @ ) and @ % in the paroxetine group ( P < @ ) .


There was no statistical difference between two groups in terms of IELT increase ( P > @ ) .


Also , there was no statistically significant difference between two groups at baseline IIEF to treatment IIEF scores .


All PEP measures improved significantly with duloxetine and paroxetine groups ( P < @ ) .


We think that duloxetine is safe and effective for the treatment for premature ejaculation .


Dietary supplements are widely used by cancer survivors .


However , health effects among older cancer survivors are unclear .


We used the Iowa Women 's Health Study , a prospective cohort study with @,@ postmenopausal women with a confirmed cancer diagnosis ( @-@ ) , to evaluate the association between postdiagnosis dietary supplement use assessed in @ and subsequent all-cause mortality .


Risk of death was evaluated using multivariable-adjusted Cox proportional hazards regression .


We performed stratified analyses by diet quality score , dietary micronutrient intake , and perceived general health .


Through @ , @ deaths were identified .


Approximately @ % of the cancer survivors used dietary supplements .


Overall supplement use and multivitamin use were not associated with mortality .


Iron supplement use was associated with @ % higher risk of death -LSB- @ % confidence interval ( CI ) , @-@ @ -RSB- .


This association was stronger among survivors with deteriorating general health .


Folic acid supplement use was associated with higher risk of death , only among survivors reporting low-quality diets ( HR , @ ; @ % CI , @-@ @ ; P interaction = @ ) .


Multivitamin use and using a greater number of supplements was associated with a trend towards higher mortality only among those with poor diet quality .


Using vitamin E supplements in combination with multivitamin was associated with lower risk of death only among survivors with higher dietary vitamin E intake ( HR , @ ; @ % CI , @-@ @ ; P interaction = @ ) .


Postdiagnosis supplement use was associated with higher mortality among older female cancer survivors with poor general health and/or poor dietary intake .


The association between postdiagnosis dietary supplement use and mortality may differ by diet quality and health status among older female cancer survivors .


This post hoc analysis assessed the efficacy of desvenlafaxine @ mg/day for treating major depressive disorder in perimenopausal versus postmenopausal women enrolled in a @-week , double-blind , placebo-controlled study .


Perimenopausal and postmenopausal women ( @-@ y ) diagnosed with major depressive disorder were randomly assigned to receive desvenlafaxine @ mg/day or placebo .


Changes from baseline in the primary efficacy variable ( @-item Hamilton Rating Scale for Depression -LSB- HAM-D@ -RSB- score , week @ ) and in other secondary efficacy variables ( Sheehan Disability Scale and Menopause Rating Scale ) were analyzed using analysis of covariance with treatment , region , and baseline in the model .


Clinical Global Impressions-Improvement Scale was analyzed with the Cochran-Mantel-Haenszel test .


Response and remission rates were evaluated using logistic regression with treatment , region , and baseline HAM-D@ in the model .


Of @ women ( desvenlafaxine , n = @ ; placebo , n = @ ) included in this analysis , @ ( @ % ) were perimenopausal and @ ( @ % ) were postmenopausal at baseline .


In both subgroups , improvement from baseline in HAM-D@ scores was significantly greater for desvenlafaxine @ mg/day than for placebo .


Menopause status and time since menopause did not significantly affect HAM-D@ total score .


The drug-placebo difference in Sheehan Disability Scale scores was significant in perimenopausal women ( -@ vs. -@ , P < @ ) but not in postmenopausal women ( -@ vs. -@ ) .


Menopause Rating Scale and Clinical Global Impressions-Improvement Scale scores were significantly improved with desvenlafaxine in postmenopausal women .


Desvenlafaxine @ mg/day is effective in treating depression in both perimenopausal and postmenopausal women .


Placebo response on measures of functional impairment is lower in perimenopausal women than in postmenopausal women , resulting in a greater apparent treatment benefit with desvenlafaxine among perimenopausal women .


Large-scale randomized clinical trials are needed to assess the role of Roux-en-Y gastric bypass ( RYGB ) in treating patients with type @ diabetes mellitus ( T@DM ) .


Recruitment challenges must be understood .


One hundred twenty participants were needed for a prospective randomized controlled trial investigating treatments for hyperglycemia and cardiovascular disease risk factors in patients with T@DM .


The trial had two arms-intensive medical management plus a rigorous lifestyle intervention ( LS/IMM ) versus LS/IMM with RYGB .


Medical inclusion criteria included glycosylated hemoglobin ( HbA@c ) @ % while under the care of a physician and body mass index ( BMI ) @-@ @ kg/m ( @ ) .


Another inclusion criterion was expressed willingness to accept randomization and participate fully .


Varied recruitment strategies were employed at four academic hospitals in the USA and Taiwan , including referrals , mass media , direct mail to patients drawn from a practice-based database , and direct mail to commercial mailing lists .


Between February @ and December @ , @,@ candidates were phone-screened and @ were screened on site ; @ participants were eventually randomized .


Impediments included stringent medical inclusion criteria and a lack of equipoise ( i.e. , strong beliefs or preferences ) among patients and their personal community-based physicians .


To meet timeline requirements , the upper limit for BMI was increased from @ to @ kg/m ( @ ) and an additional site was added .


We successfully recruited @ participants with poorly controlled T@DM and mild to moderate obesity .


Participants had to be willing to accept randomization to either surgical or nonsurgical treatments .


Recruitment took @ years .


The aim of this study was to evaluate the effects of pre-warmed ( approximately @ C ) intravenous fluids ( IV ) on perioperative hypothermia and postoperative shivering in female patients undergoing short , ambulatory urological surgery under monitored anesthesia care ( MAC ) .


Patients between the ages of @ and @ years were randomly assigned to either the pre-warmed ( n = @ ) or the room temperature ( n = @ ) group .


According to group allocation , either pre-warmed IV fluids that had been stored in a warming cabinet for at least @ h or room temperature IV fluids were administered intraoperatively up to approximately @-@ ml , including a bolus infusion of @ ml/kg within @ min .


Perioperative core temperatures at the tympanic membrane , postoperative shivering , subjective thermal comfort , and the use of forced-air warming interventions in the post-anesthesia care unit ( PACU ) were recorded .


Mean core temperatures were significantly higher in the pre-warmed group than they were in the room temperature group after @ ml/kg preload fluid was administered , at the end of the operation , and on admission to the PACU ( p = @ , p = @ , and p = @ , respectively ) .


The incidence of hypothermia ( < @ C ) was significantly lower in the pre-warmed group ( n = @ ) than in the room temperature group ( n = @ , p = @ ) upon PACU admission .


The postoperative shivering incidence was also significantly lower in the pre-warmed group ( n = @ ) than in the room temperature group ( n = @ , p = @ ) .


Infusion of pre-warmed IV fluid improved the postoperative recovery profile by decreasing hypothermia and shivering in female patients undergoing short , ambulatory urological surgery under MAC .


Studies have indicated a blood pressure ( BP ) - lowering effect of milk-derived peptides in non-diabetic individuals , but the cardiometabolic effects of such peptides in patients with type @ diabetes ( T@D ) are not known .


We investigated the effect of milk fermented with Lactobacillus helveticus on BP , glycaemic control and cardiovascular risk factors in T@D .


A randomised , double-blinded , prospective , placebo-controlled study .


In one arm of a factorial study design , @ patients with T@D were randomised to receive @ ml milk fermented with L. helveticus ( Cardi@ yogurt ) ( n = @ ) or @ ml artificially acidified milk ( placebo yogurt ) ( n = @ ) for @ weeks .


BPs were measured over @-h , and blood samples were collected in the fasting state and during a meal test before and after the intervention .