At the time of surgery and at each subsequent bandage change , wound beds were swabbed and submitted for aerobic and anaerobic culture .


After initiating cefazolin treatment , wound tissue antibiotic concentrations between treatment groups were not significantly different at any sampling time .


Similarly , after initiating cefazolin treatment , plasma cefazolin concentrations were not significantly different at any sampling time for individual dogs .


Using a canine experimental model , NPWT treatment of surgically created wounds does not statistically impact cefazolin tissue concentrations when compared with conventional nonadherent bandage therapy .


The objective of this study was to evaluate the influence of cardiopulmonary bypass ( CPB ) on endothelin-@ ( ET-@ ) expression in various circulation compartments in patients undergoing myocardial revascularization .


A total of @ patients were randomized to undergo myocardial revascularization with ( CABG , n = @ ) or without ( OPCAB , n = @ ) CPB .


Samples were taken preoperatively , after establishing CPB and after CPB ( CABG group ) , prior to and after revascularization ( OPCAB group ) , and @ and @ h postoperatively .


Values of ET-@ were compared between groups at all time points and correlated with postoperative cardioselective enzyme values and clinical parameters .


In OPCAB group , ET-@ levels did not significantly vary between time points .


In CABG group , ET-@ levels were significantly elevated vs. baseline in arterial : ART-T@ vs. ART-T@ ( @ @ vs. @ @ fmol/mL , p = @ ) , pulmonary : SG-T@ vs. SG-T@ ( @ @ vs. @ @ fmol/mL , p < @ ) and SG-T@ vs. SG-T@ ( @ @ vs. @ @ fmol/mL , p < @ ) , and coronary circulation CS-T@ vs. CS-T@ ( @ @ vs. @ @ fmol/mL , p = @ ) .


ET-@ levels were significantly higher in CABG group in all vascular compartments : ART-T@ ( @ @ vs. @ @ fmol/mL , p = @ ) , ART-T@ ( @ @ vs. @ @ fmol/mL , p = @ ) , SG-T@ ( @ @ vs. @ @ fmol/mL , p = @ ) , SG-T@ ( @ @ vs. @ @ fmol/mL , p = @ ) , SG-T@ ( @ @ vs. @ @ fmol/mL , p < @ ) , SG-T@ ( @ @ vs. @ @ fmol/mL , p < @ ) , and CS-T@ ( @ @ vs. @ @ fmol/mL , p = @ ) .


Coronary sinus ET-@ level after CPB ( CS-T@ ) in CABG group correlated positively with troponin-I level @ h postoperatively ( r ( @ ) = @ , p = @ ) CONCLUSION : Off-pump myocardial revascularization attenuates ET-@ expression in all investigated vascular compartments .


Elevated coronary ET-@ levels after CPB in CABG group correlate with troponin-I levels @ h postoperatively .


To compare open and closed methods of the frontalis suspension operation with a silicone rod in the treatment of congenital blepharoptosis .


Forty-four cases with unilateral or bilateral congenital ptosis with a poor levator function of < @ mm were divided randomly into two groups .


Each group underwent an eyelid crease incision operation ( open ) or a supralash stab incision ( closed ) .


Ptosis was measured by the difference between the upper eyelid margin reflex distance ( MRD ) of the affected eyelids of the unilateral and bilateral cases .


Frequent follow-up examinations were performed up to @ months post-surgery .


Associated ophthalmologic findings showed that amblyopia , strabismus , wound discharge and knot dehiscence problems were present in @ % , @ % , @ % and @ % of the patients , respectively .


There was no significant difference between the abovementioned associated ophthalmic findings of the two operative methods studied ( P = @ ) .


The difference in the surgical methods and MRD @ , @ and @ months after operation did not reach statistical significance .


Similar results for good MRD ( @ < MRD < @ ) were found in closed ( @ % , @/@ ) and open ( @ % , @/@ ) methods , while @ % ( @/@ ) and @ % ( @/@ ) of cases were attributed to the under correction group in the closed and open methods , respectively .


In bilaterally operated cases , MRD was more symmetrical than in unilaterally operated eyes .


The symmetry of MRD and the eyelid crease was more prevalent in the open technique group .


The frontalis sling operation using a silicone rod exhibited better results , in terms of symmetry , in the open technique in comparison to the closed method .


Sepsis complication is a major cause of death in multiple trauma critically ill patients .


Defensin ( cysteine rich anti-microbial peptides ) , as an important component of immune system , might play an important role in this process .


There is also rising data on immunological effects of N-acetyl-cysteine ( NAC ) , a commonly used anti-oxidant in oxidative stress conditions and glutathione ( GSH ) deficiencies .


The aim of the present study was to evaluate the potential beneficial effects of NAC administration on multiple trauma patients with sepsis .


In a prospective , randomized controlled study , @ multiple trauma critically ill patients who were mechanically ventilated and met the criteria of sepsis and admitted to the intensive care unit ( ICU ) were randomized into two groups .


Control group received all standard ICU therapies and NAC group received intravenous NAC @ gr every @ hours for @ hours in addition to standard therapies .


Acute Physiology and Chronic Health Evaluation II ( APACHE II ) and Sequential Organ Failure Assessment ( SOFA ) scores , length of ICU stay , ICU mortality were recorded .


Levels of serum Immunoglobulin M ( IgM ) , Human - Defensin @ ( HD@ ) and GSH were assessed at baseline and @ , @ , @ hours after intervention .


During a period of @-month screening , @ patients underwent randomization but @ patients had to be excluded .


@ patients in NAC group and @ patients in control group completed the study .


For both groups the length of ICU stay , SOFA score and systemic oxygenation were similar .


Mortality rate ( @ % vs. @ % respectively , p = @ ) and ventilator days ( MeanSD @ days vs. @ days respectively , p = @ ) were slightly higher for NAC group .


IgM and GSH levels were similar between two groups ( p = @ , @ respectively ) , HD@ levels were higher for NAC group ( at day @ ) .


High dose of NAC administration not only did not improve patients ' outcome , but also raised the risk of inflammation and was associated with increased serum creatinine .


The aim of this study was to examine proprioceptive performance in adults with hemiplegic cerebral palsy and the possibility that a home-based sensorimotor training program could improve proprioceptive performance .


This study is a preintervention/postintervention assessment of @ adults participating in a home-based program consisting of targeted unilateral and bilateral reaching movements , hand manipulation tasks , tactile discrimination , and stereognosis .


It did not specifically include proprioceptive tasks .


Training sessions were @ mins , @ days per week , for @ wks .


Limb position sense was assessed using three conditions : ipsilateral remembered ( same arm used for reference and matching targets ) , contralateral concurrent ( reference arm moved and held at target position while opposite arm matched reference position ) , and contralateral remembered ( reference arm moved to target position and then returned to start position before opposite arm matching position ) .


The participants demonstrated greater absolute and constant error when the more affected arm served as the reference arm , and matching was performed by the less affected arm , particularly in the contralateral remembered condition .


After training , the participants demonstrated less absolute error across matching tasks and no change in constant error .


The results suggest an important role for the reference arm in bilateral position matching tasks and the potential for improved proprioceptive performance after training in movement and unrelated sensory tasks .


Suicidal behaviours in adolescents are a major public health problem and evidence-based prevention programmes are greatly needed .


We aimed to investigate the efficacy of school-based preventive interventions of suicidal behaviours .


The Saving and Empowering Young Lives in Europe ( SEYLE ) study is a multicentre , cluster-randomised controlled trial .


The SEYLE sample consisted of @,@ adolescent pupils , median age @ years ( IQR @-@ ) , recruited from @ schools in ten European Union countries .


We randomly assigned the schools to one of three interventions or a control group .


The interventions were : ( @ ) Question , Persuade , and Refer ( QPR ) , a gatekeeper training module targeting teachers and other school personnel , ( @ ) the Youth Aware of Mental Health Programme ( YAM ) targeting pupils , and ( @ ) screening by professionals ( ProfScreen ) with referral of at-risk pupils .


Each school was randomly assigned by random number generator to participate in one intervention ( or control ) group only and was unaware of the interventions undertaken in the other three trial groups .


The primary outcome measure was the number of suicide attempt ( s ) made by @ month and @ month follow-up .


Analysis included all pupils with data available at each timepoint , excluding those who had ever attempted suicide or who had shown severe suicidal ideation during the @ weeks before baseline .


This study is registered with the German Clinical Trials Registry , number DRKS@ .


Between Nov @ , @ , and Dec @ , @ , @ schools ( @,@ pupils ) were randomly assigned to interventions ( @ schools -LSB- @ pupils -RSB- to QPR , @ -LSB- @ -RSB- YAM , @ -LSB- @ -RSB- ProfScreen , and @ -LSB- @ -RSB- control ) .


No significant differences between intervention groups and the control group were recorded at the @ month follow-up .


At the @ month follow-up , YAM was associated with a significant reduction of incident suicide attempts ( odds ratios -LSB- OR -RSB- @ , @ % CI @-@ ; p = @ ) and severe suicidal ideation ( @ , @-@ ; p = @ ) , compared with the control group .


@ pupils ( @ % ) reported incident suicide attempts at the @ month follow-up in the YAM versus @ ( @ % ) in the control group , and @ pupils ( @ % ) reported incident severe suicidal ideation in the YAM group versus @ ( @ % ) in the control group .


No participants completed suicide during the study period .


YAM was effective in reducing the number of suicide attempts and severe suicidal ideation in school-based adolescents .


These findings underline the benefit of this universal suicide preventive intervention in schools .


Bolus injections of intravenous propofol and remifentanil can be used in the tracheal intubation of infants and children , but relatively large doses are needed .


We hypothesised that addition of a small bolus of rocuronium would ensure good intubation conditions when modest propofol and remifentanil doses were used .


Seventy infants between @ weeks and @ months of age were randomised to receive either placebo or rocuronium .


Anaesthesia was induced with IV propofol , @ ( @-@ ) mg/kg -LSB- median ( range ) -RSB- .


Rocuronium ( @ mg/kg ) or placebo was then injected , followed @s later by @g/kg remifentanil .


One anaesthetist attempted tracheal intubation @min after the rocuronium/placebo injection and used the ` Copenhagen scoring system ' to assess intubation conditions .


The neuromuscular effect of @ mg/kg rocuronium was recorded in another eight , already intubated , infants using thumb accelerometry during train-of-four stimulation of the ulnar nerve .


Intubation conditions were classified as ` poor ' in @ of @ ( @ % ) patients given placebo and in @ of @ ( @ % ) patients given rocuronium ( P = @ ) .


There were four failed first attempts at intubation in the placebo group and none in the rocuronium group ( P = @ ) .


Maximum neuromuscular depression occurred @ ( @-@ ) after injection of @ mg/kg rocuronium .


Intubation conditions were poor in almost one third of the patients receiving propofol-remifentanil .


Adding a low-dose rocuronium did not significantly improve intubation conditions .


To compare the difference in the clinical efficacy on primary trigeminal neuralgia ( PTN ) between the comprehensive therapy of electroacupuncture ( EA ) at qi streets acupoints combined with spinal regulation method and medication with carbamazepine ( CBZ ) .


Sixty patients were randomized into a comprehensive therapy group ( @ cases ) and a medication group ( @ cases ) .


In the comprehensive therapy group , the acupoints at qi streets on the head such as Taiyang ( EX-HN @ ) and Sishencong ( EX-HN @ ) and those at qi streets on the chest and abdomen such as Shenshu ( BL @ ) , Zhongwan ( CV @ ) and Guanyuan ( CV @ ) , etc. were selected .


After arrival of qi , EA was attached on @ to @ groups of acupoints .


After acupuncture , the spinal regulation method was applied .


This comprehensive therapy was given once a day .


In the medication group , CBZ was used for oral administration , @ mg at the first time , twice a day , and @ to @ mg each day as the maintenance dose .


Separately , before and after treatment , in @ and @ months in follow-up , pain rating index ( PRI ) , life satisfaction index B ( LSI-B ) and hamilton depression scale ( HAMD ) were adopted to evaluate comprehensively the clinical efficacy in the two groups and compare the adverse reaction during the treatment between the two groups .


After treatment , the curative and markedly effective rate in the comprehensive therapy group was @ % ( @/@ ) , which was better than @ % ( @/@ ) in the medication group ( P < @ ) .


The difference in PRI was not significant after treatment between the two groups ( all P > @ ) .


In @ and @ months follow-up , PRI grade in the comprehensive therapy group was superior to that of the medication group ( both P < @ ) .


After treatment and in follow-up , HAMD score was all reduced in the two groups ( P < @ , P < @ ) and the result in follow-up in the comprehensive therapy group was significant as compared with that in the medication group ( all P < @ ) .


After treatment , LSI-B score was increased obviously in the two groups ( all P < @ ) and the result in the comprehensive therapy group was better than that in the medication group ( P < @ ) .


The incidence of adverse reaction in the comprehensive therapy group was @ % ( @/@ ) , which was lower than @ % ( @/@ , P < @ ) in the medication group .


The comprehensive therapy of EA at qi streets acpoints combined with spinal regulation method achieves the long-term efficacy on PTN as compared with oral administration of CBZ in terms of the improvement of psychological condition , analgesia and life quality .


It is the safe , effective and stable therapy .


To evaluate the effectiveness of chest physiotherapy ( CPT ) , which provides slow and long expiratory flow and assisted cough techniques , in infants receiving outpatient care for acute wheezing episodes .


Forty-eight infants with moderate acute wheezing episodes were randomised to receive either salbutamol MDI with CPT ( n = @ ) or without CPT ( n = @ ) .


The clinical score and SpO@ levels were recorded , before and after treatment , in a blinded design .


The primary outcome was discharge after the first hour of treatment : clinical score @/@ and SpO@ @ % .


Secondary outcomes were the number of admissions to hospital after the second hour , use of oral corticosteroid bursts and admissions to hospital on day seven .


There were no differences between children with and without CPT in discharge rate ( @ % vs. @ % ) , clinical score ( median -LSB- IQR -RSB- : @ -LSB- @-@ @ -RSB- vs. @ -LSB- @-@ @ -RSB- ) and SpO@ = ( @ -LSB- @-@ @ -RSB- vs. @ -LSB- @-@ @ -RSB- ) after the first hour of treatment or in the number of hospital admissions after the second hour .


No differences were observed at days seven and @ following treatment .


There was no evidence of clinical benefits from these specific CPT techniques for infants receiving outpatient care for acute wheezing episodes .


- alanine ( BAl ) and NaHCO@ ( SB ) ingestion may provide performance benefits by enhancing concentrations of their respective physiochemical buffer counterparts , muscle carnosine and blood bicarbonate , counteracting acidosis during intense exercise .


This study examined the effect of BAl and SB co-supplementation as an ergogenic strategy during high-intensity exercise .


Eight healthy males ingested either BAl ( @ g day ( -@ ) for @ weeks , increased to @ g day ( -@ ) for @ weeks ) or placebo ( Pl ) ( CaCO@ ) for @ weeks , in a crossover design ( @-week washout between supplements ) .


After each chronic supplementation period participants performed two trials , each consisting of two intense exercise tests performed over consecutive days .


Trials were separated by @ week and consisted of a repeated sprint ability ( RSA ) test and cycling capacity test at @ % Wmax ( CCT@ % ) .


Placebo ( Pl ) or SB ( @ mg kgbw ( -@ ) ) was ingested prior to exercise in a crossover design to creating four supplement conditions ( BAl-Pl , BAl-SB , Pl-Pl , Pl-SB ) .


Carnosine increased in the gastrocnemius ( n = @ ) ( p = @ ) and soleus ( n = @ ) ( p = @ ) following BAl supplementation , and Pl-SB and BAl-SB ingestion elevated blood HCO@ ( - ) concentrations ( p < @ ) .


Although buffering capacity was elevated following both BAl and SB ingestion , performance improvement was only observed with BAl-Pl and BAl-SB increasing time to exhaustion of the CCT@ % test @ and @ % , respectively , compared to Pl-Pl ( p < @ ) .


Supplementation of BAl and SB elevated buffering potential by increasing muscle carnosine and blood bicarbonate levels , respectively .


BAl ingestion improved performance during the CCT@ % , with no aggregating effect of SB supplementation ( p > @ ) .


Performance was not different between treatments during the RSA test .


Glycated proteins ( advanced glycation endproducts , AGE ) in tissue are associated with degenerative diseases .


This study evaluated the role of sRAGE ( soluble receptor for advanced glycation endproducts ) , a decoy receptor of AGEs in blood , for the outcome of patients after coronary artery bypass grafting ( CABG ) .


A total of @ patients undergoing CABG were analysed in two centres .


Perioperative blood samples were collected before surgery up to @week postoperatively .


sRAGE was measured by ELISA .


Patients were subdivided regarding age ( < @ versus > @years , @ % versus @ % female ) , euroSCORE ( < @ versus > @ , @ % versus @ % female ) and sRAGE changes between sternotomy and end of the operation ( < @ % versus > @ % , @ % versus @ % female ) and subsequently analysed with respect of postoperative outcome parameters .


Preoperative sRAGE values did not correlate with the outcome of the patients .


sRAGE levels increase within @min from @,@ to @,@ pg/ml after sternotomy , then returning to baseline levels within @days after surgery .


Comparing the analysed possible risk factors age , euroSCORE and sRAGE changes , no difference was observed regarding @-day mortality .


Age and the euroSCORE are superior with respect of tachyarrythmia , whereas sRAGE kinetics seems to be superior with respect of prolonged postoperative respiration time/stay in the intensive care unit or catecholamine support .


A prolonged , increased intraoperative sRAGE level is a new outcome predictor for patients undergoing CABG surgery , mutually complementary to the euroSCORE .


Scarce physical activity predicts shorter survival in dialysis patients .


However , the relationship between physical ( motor ) fitness and clinical outcomes has never been tested in these patients .


We tested the predictive power of an established metric of motor fitness , the Six-Minute Walking Test ( @MWT ) , for death , cardiovascular events and hospitalization in @ dialysis patients who took part in the trial EXCITE ( ClinicalTrials.gov Identifier : NCT@ ) .


During follow up @ patients died , @ had fatal and non-fatal cardiovascular events , @ were hospitalized and @ patients had the composite outcome .


In multivariate Cox models - including the study allocation arm and classical and non-classical risk factors - an increase of @ walked metres during the @MWT was associated to a @ % reduction of the risk for the composite end-point ( P = @ ) and a similar relationship existed between the @MWT , mortality ( P < @ ) and hospitalizations ( P = @ ) .


A similar trend was observed for cardiovascular events but this relationship did not reach statistical significance ( P = @ ) .


Poor physical performance predicts a high risk of mortality , cardiovascular events and hospitalizations in dialysis patients .


Future studies , including phase-@ EXCITE , will assess whether improving motor fitness may translate into better clinical outcomes in this high risk population .


Wire-guided cannulation has become a common biliary cannulation technique worldwide .


Different guidewires with various tip shapes and materials have been reportedly used for wire-guided cannulation .


However , there are apparently no studies reporting changes in the biliary cannulation rate according to the type of guidewire used .


We evaluated the effectiveness of the J-tip guidewire for biliary cannulation .


We conducted a prospective , multicenter , controlled study involving patients with a native papilla who required biliary cannulation .


We allocated the patients to the J-tip guidewire or angled-tip guidewire groups ( groups J and A , respectively ) .


If biliary cannulation was not achieved within @min , the GW was changed and cannulation was continued .


Groups J and A consisted of @ and @ enrolled patients , respectively .


The biliary cannulation rate with a single guidewire for the first @min was @ % ( @/@ ) for group J and @ % ( @/@ ) for group A.


The final success rate for biliary cannulation was @ % in both groups .


The mean times necessary for biliary cannulation were @ and @ s in group J and group A , respectively .


The incidence rates of complications ( i.e. , all mild pancreatitis ) were @ % ( @/@ ) and @ % ( @/@ ) in group J and group A , respectively .


The mean amylase concentrations were @ and @ IU/L in group J and group A , respectively .


There were no significant differences in any results between both groups .


The biliary cannulation rate of the J-tip guidewire was not significantly different from those of standard guidewires .


Recent biomechanical evidence suggests that the meniscus-suture interface contributes the most displacement to the transtibial pull-out repair for meniscal root tears .


Therefore , optimization of surgical technique at the meniscus-suture interface may minimize displacement and improve the strength of meniscal root repairs .


The purpose of this study was to investigate the cyclic displacement and ultimate failure loads of @ different meniscus-suture fixation techniques for posterior medial meniscal root repairs in human meniscus tissue .


The hypothesis was that there would be no significant difference between the two simple sutures ( TSS ) technique and @ other techniques in cyclic displacement or ultimate failure load .


Controlled laboratory study .


A total of @ fresh-frozen , human , medial meniscal transplant specimens were randomly assigned to @ meniscus-suture fixation techniques used for transtibial pull-out repair in posterior medial meniscal root tears ( n = @ per group ) .


The suture techniques studied were ( @ ) TSS , ( @ ) modified Mason-Allen ( MMA ) , ( @ ) single double-locking loop ( S-DLL ) , and ( @ ) double double-locking loop ( D-DLL ) .


The menisci were subjected to a cyclic tensioning protocol representative of postoperative rehabilitation ( @-@ N for @ cycles ) and pulled to failure at a rate of @ mm/s .


After @ cycles , the TSS group displaced the least ( mean SD , @ @ mm ) , followed by the MMA ( @ @ mm ) , D-DLL ( @ @ mm ) , and S-DLL ( @ @ mm ) groups .


After @ , @ , and @ cycles , suture displacements using the TSS and MMA techniques were not significantly different ( P > @ ) , while the TSS technique resulted in significantly less displacement than the S-DLL and D-DLL ( P < @ ) techniques .


The ultimate failure loads of the MMA ( @ @ N ) and D-DLL ( @ @ N ) techniques were significantly greater than those of the TSS ( @ @ N ) and S-DLL ( @ @ N ) techniques ( P < @ ) .


The TSS and MMA fixation techniques were not significantly different , while the TSS was significantly better at resisting displacement when compared with the S-DLL and D-DLL stitch configurations .


The MMA and D-DLL techniques exhibited significantly greater failure loads than did the TSS and S-DLL techniques ; however , all techniques demonstrated ultimate failure loads above the currently accepted rehabilitation force threshold .


The TSS fixation technique combines the lowest technical difficulty and the ability to resist displacement at time zero .


The MMA technique , although more technically challenging , may provide an alternative means to resist displacement while enhancing the failure load .


Transcranial direct current stimulation ( tDCS ) of the primary motor cortex has been shown to modulate pain and trigeminal nociceptive processing .


Ten patients with classical trigeminal neuralgia ( TN ) were stimulated daily for @minutes over two weeks using anodal ( @mA ) or sham tDCS over the primary motor cortex ( M@ ) in a randomized double-blind cross-over design .


Primary outcome variable was pain intensity on a verbal rating scale ( VRS @-@ ) .


VRS and attack frequency were assessed for one month before , during and after tDCS .


The impact on trigeminal pain processing was assessed with pain-related evoked potentials ( PREP ) and the nociceptive blink reflex ( nBR ) following electrical stimulation on both sides of the forehead before and after tDCS .


Anodal tDCS reduced pain intensity significantly after two weeks of treatment .


The attack frequency reduction was not significant .


PREP showed an increased N@ latency and decreased peak-to-peak amplitude after anodal tDCS .


No severe adverse events were reported .


Anodal tDCS over two weeks ameliorates intensity of pain in TN .


It may become a valuable treatment option for patients unresponsive to conventional treatment .


Type @ diabetes , also known non-insulin-dependent diabetes , is the most prevalent type of the disease and involves defects in the secretion and action of insulin .


The aim of the proposed study is to evaluate the efficacy of pre-exercise low-level laser therapy ( LLLT ) on muscle performance of the quadriceps femoris in individuals with type @ diabetes .


A double-blind , randomized , controlled clinical trial will be carried out in two treatment phases .


In the first phase , quadriceps muscle performance will be evaluated using an isokinetic dynamometer and the levels of creatine kinase and lactate dehydrogenase ( biochemical markers of muscle damage ) will be determined .


The participants will then be allocated to four LLLT groups through a randomization process using opaque envelopes : Group A ( @ Joules ) , Group B ( @ Joules ) , Group C ( @ Joules ) and Group D ( @ Joules ; placebo ) .


Following the administration of LLLT , the participants will be submitted to an isokinetic eccentric muscle fatigue protocol involving the quadriceps muscle bilaterally .


Muscle performance and biochemical markers of muscle damage will be evaluated again immediately after as well as @ and @hours after the experimental protocol .


One week after the last evaluation the second phase will begin , during which Groups A , B and C will receive the LLLT protocol that achieved the best muscle performance in phase @ for a period of @weeks .


At the end of this period , muscle performance will be evaluated again .


The protocol for this study is registered with the World Health Organization under Universal Trial Number U@-@-@ .


The purpose of this randomized clinical trial is to evaluate the efficacy of pre-exercise LLLT on the performance of the quadriceps muscle ( peak torque , total muscle work , maximum power and fatigue index - normalized by body mass ) in individuals with DM-@ .


The study will support the practice of evidence-based to the use of LLLT in improving muscle performance in Individuals with DM-@ .


Data will be published after the study is completed .


Skin cancer survivors experience an increased risk for subsequent malignancies but the associated risk factors are poorly understood .


This study examined the risk of a new primary cancer following an initial skin cancer and assessed risk factors associated with second primary cancers .


All invasive cutaneous malignant melanomas ( CMM , N = @ @ ) and squamous cell carcinomas ( SCC , N = @ @ ) diagnosed in Norway during @-@ were included .


Rates of new primary cancers in skin cancer survivors were compared to rates of primary malignancies in the general population using standardized incidence ratios ( SIR ) .


Discrete-time logistic regression models were applied to individual-level data to estimate cancer risk among those with and without a prior skin cancer , accounting for residential region , education , income , parenthood , marital status and parental cancer status , using a @ % random sample of the entire Norwegian population as reference .


Further analyses of the skin cancer cohort were undertaken to determine risk factors related to subsequent cancers .


During follow-up , @ new primary cancers occurred after an initial skin cancer .


SIR analyses showed @ % and @ % increased risks for any cancer after CMM and SCC , respectively ( p < @ ) .


The logistic regression model suggested even stronger increase after SCC ( @ % ) .


The highest risk was seen for subsequent skin cancers , but several non-skin cancers were also diagnosed in excess : oral , lung , colon , breast , prostate , thyroid , leukemia , lymphoma and central nervous system .


Factors that were associated with increased risk of subsequent cancers include male sex , older age , lower residential latitude , being married and low education and income .


Parental cancer did not increase the risk of a subsequent cancer after SCC , but was a significant predictor among younger CMM survivors .


Our results provide information on shared environmental and genetic risk factors for first and later cancers and may help to identify individuals at high risk for subsequent cancers , which will be important as skin cancer incidence continues to rise .


The aim of this study was to evaluate the @-month effect of a single automated thermodynamic treatment ( LipiFlow ) and implications of meibomian gland atrophy on treatment efficacy @ months after application .


We analyzed the data of @ subjects with meibomian gland dysfunction before and @ months after treatment .


Investigated parameters included subjective symptoms , lipid layer thickness , meibomian gland assessment , tear osmolarity , corneal and conjunctival staining , lid margin parallel conjunctival folds , Schirmer test values , bulbar redness , tear meniscus height , meibomian gland atrophy , and noninvasive tear break-up time .


Subjective symptoms ( mean Ocular Surface Disease Index , @ @ to @ @ ; P = @ , mean Standard Patient Evaluation of Eye Dryness @ @ to @ @ ; P = @ ) , lipid layer thickness ( @ @ to @ @ ; P = @ ) , number of expressible glands ( @ @ to @ @ ; P < @ ) , lid margin parallel conjunctival folds ( @ @ to @ @ ; P = @ ) , and bulbar redness ( @ @ to @ @ ; P = @ ) were all improved @ months after treatment .


Symptomatic improvement was higher in patients with less severe meibomian gland atrophy compared with patients with more dropout at treatment .


There was no change of meibomian gland atrophy @ months after treatment .


In summary , the results showed that a single thermodynamic treatment is effective in the treatment of meibomian gland dysfunction and that the effects last for at least @ months .


We suggest performing meibography in every patient before treatment for better prediction of therapeutic effects .


The aging process involves a decline in immune functioning that renders elderly people more vulnerable to disease .


In residential programs for the aged , it is vital to diminish their risk of disease , promote their independence , and augment their psychological well-being and quality of life .


We performed a randomized controlled study , evaluating the ability of a relaxation technique based on Benson 's relaxation response to enhance psychological well-being and modulate the immune parameters of elderly people living in a geriatric residence when compared to a waitlist control group .


The study included a @-week intervention period and a @-month follow-up period .


The main outcome variables were psychological well-being and quality of life , biomedical variables , immune changes from the pre-treatment to post-treatment and follow-up periods .


Our findings reveal significant differences between the experimental and control groups in CD@ , CD@ , CD@ , CD@ , and CD@ lymphocyte subpopulations at the end of treatment .


Furthermore , there was a decrease in negative affect , psychological discomfort , and symptom perception in the treatment group , which increased participants ' quality of life scores at the three-month follow-up .


This study represents a first approach to the application of a passive relaxation technique in residential programs for the elderly .


The method appears to be effective in enhancing psychological well-being and modulating immune activity in a group of elderly people .


This relaxation technique could be considered an option for achieving health benefits with a low cost for residential programs , but further studies using this technique in larger samples of older people are needed to confirm the trends observed in the present study .


This phase II , open-label study investigated intercalated combinations of eribulin and erlotinib in unselected patients with advanced non-small-cell lung cancer previously treated with platinum-based chemotherapies .


Eligible patients were randomized to eribulin mesylate @ mg/m ( @ ) on day @ with erlotinib @ mg on days @-@ ( @-day regimen ) or eribulin mesylate @ mg/m ( @ ) on days @ and @ with erlotinib @ mg on days @-@ ( @-day regimen ) .


The primary end point was objective response rate ( ORR ) .


One hundred and twenty-three patients received @ cycle of therapy ( @ , @-day regimen ; @ , @-day regimen ) .


ORRs were @ % -LSB- @ % confidence interval ( CI ) @ % -@ % -RSB- and @ % ( @ % CI @ % -@ % ) , and disease control rates were @ % ( @ % CI @ % -@ % ) and @ % ( @ % CI @ % -@ % ) for the @ - and @-day regimens , respectively .


The median progression-free survival and overall survival were similar with both regimens .


Both regimens were well tolerated with common grade @ toxicities being neutropenia , asthenia/fatigue , and dyspnoea .


Sequential administration of erlotinib did not interfere with the pharmacokinetic profile of eribulin .


Intercalated combination of eribulin and erlotinib demonstrated modest activity and the addition of erlotinib did not appear to improve treatment outcome in an unselected population .


The @-day regimen is suitable for further investigation .


Clinicaltrials.gov identifier : NCT@ .


There is evidence that new methods of noninvasive ventilation ( NIV ) support have significantly changed respiratory distress syndrome ( RDS ) management in preterm infants .


Further perspectives for neonatologists involve the assessment of different NIV strategies in terms of availability , effectiveness , and failure .


This study evaluates the efficacy of @ different NIV strategies for RDS treatment in very low birth weight ( VLBW ) infants : nasal synchronized intermittent positive pressure ventilation ( NSIPPV ) , which is a modality of conventional ventilation with intermittent peak inspiratory pressure , and bilevel continuous positive airway pressure ( BiPAP ) , not synchronized , with @ alternate levels of continuous positive airway pressure .


We conducted a @-center randomized control study in @ VLBW infants ( < @ g and < @ weeks of gestational age ) with RDS who received NIV support ( NSIPPV , n = @ ; BiPAP , n = @ ) within @ hours of birth .


We evaluated the performance of NIV strategies by selected primary outcomes ( failure rate and duration of ventilation ) and secondary outcomes .


The number of failures and duration of ventilation support did not differ between NSIPPV and BiPAP strategies ( P > @ for both ) .


Moreover , no differences between groups were found regarding secondary outcomes ( P > @ for all ) .


The present data show no statistically significant differences between NSIPPV and BiPAP strategies in terms of duration of ventilation and failures , suggesting that both NIV techniques are effective in the early treatment of RDS in VLBW infants .


Further randomized investigations on wider populations are needed to evaluate the effect of NIV techniques on long-term outcomes .


Among patients undergoing mitral-valve surgery , @ to @ % present with atrial fibrillation , which is associated with reduced survival and increased risk of stroke .


Surgical ablation of atrial fibrillation has been widely adopted , but evidence regarding its safety and effectiveness is limited .


We randomly assigned @ patients with persistent or long-standing persistent atrial fibrillation who required mitral-valve surgery to undergo either surgical ablation ( ablation group ) or no ablation ( control group ) during the mitral-valve operation .


Patients in the ablation group underwent further randomization to pulmonary-vein isolation or a biatrial maze procedure .


All patients underwent closure of the left atrial appendage .


The primary end point was freedom from atrial fibrillation at both @ months and @ months ( as assessed by means of @-day Holter monitoring ) .


More patients in the ablation group than in the control group were free from atrial fibrillation at both @ and @ months ( @ % vs. @ % , P < @ ) .


There was no significant difference in the rate of freedom from atrial fibrillation between patients who underwent pulmonary-vein isolation and those who underwent the biatrial maze procedure ( @ % and @ % , respectively ; P = @ ) .


One-year mortality was @ % in the ablation group and @ % in the control group ( hazard ratio with ablation , @ ; @ % confidence interval , @ to @ ; P = @ ) .


Ablation was associated with more implantations of a permanent pacemaker than was no ablation ( @ vs. @ per @ patient-years , P = @ ) .


There were no significant between-group differences in major cardiac or cerebrovascular adverse events , overall serious adverse events , or hospital readmissions .


The addition of atrial fibrillation ablation to mitral-valve surgery significantly increased the rate of freedom from atrial fibrillation at @ year among patients with persistent or long-standing persistent atrial fibrillation , but the risk of implantation of a permanent pacemaker was also increased .


( Funded by the National Institutes of Health and the Canadian Institutes of Health Research ; ClinicalTrials.gov number , NCT@ . )


Coenzyme Q@ ( CoQ@ ) , an antioxidant that supports mitochondrial function , has been shown in preclinical Parkinson disease ( PD ) models to reduce the loss of dopamine neurons , and was safe and well tolerated in early-phase human studies .


A previous phase II study suggested possible clinical benefit .


To examine whether CoQ@ could slow disease progression in early PD .


A phase III randomized , placebo-controlled , double-blind clinical trial at @ North American sites consisting of participants @ years of age or older who received a diagnosis of PD within @ years and who had the following inclusion criteria : the presence of a rest tremor , bradykinesia , and rigidity ; a modified Hoehn and Yahr stage of @ or less ; and no anticipated need for dopaminergic therapy within @ months .


Exclusion criteria included the use of any PD medication within @ days , the use of any symptomatic PD medication for more than @ days , atypical or drug-induced parkinsonism , a Unified Parkinson 's Disease Rating Scale ( UPDRS ) rest tremor score of @ or greater for any limb , a Mini-Mental State Examination score of @ or less , a history of stroke , the use of certain supplements , and substantial recent exposure to CoQ@ .


Of @ participants screened , @ were found to be ineligible , and @ declined participation .


The remaining @ participants were randomly assigned to receive placebo , @ mg/d of CoQ@ , or @ mg/d of CoQ@ ; all participants received @ IU/d of vitamin E.


Participants were observed for @ months or until a disability requiring dopaminergic treatment .


The prospectively defined primary outcome measure was the change in total UPDRS score ( Parts I-III ) from baseline to final visit .


The study was powered to detect a @-point difference between an active treatment and placebo .


The baseline characteristics of the participants were well balanced , the mean age was @ years , @ % of participants were male , and the mean baseline total UPDRS score was @ .


A total of @ participants required treatment ( @ received placebo , @ received @ mg/d of CoQ@ , and @ received @ mg/d of CoQ@ ) , and @ participants ( @ who received placebo , @ who received @ mg/d of CoQ@ , and @ who received @ mg/d of CoQ@ ) withdrew prematurely .


Treatments were well tolerated with no safety concerns .


The study was terminated after a prespecified futility criterion was reached .


At study termination , both active treatment groups showed slight adverse trends relative to placebo .


Adjusted mean changes ( worsening ) in total UPDRS scores from baseline to final visit were @ points ( placebo ) , @ points ( @ mg/d of CoQ@ ; P = @ relative to placebo ) , and @ points ( @ mg/d of CoQ@ ; P = @ relative to placebo ) .


Coenzyme Q@ was safe and well tolerated in this population , but showed no evidence of clinical benefit .


Historically , the preoperative consultation has consisted of a discussion between patient and surgeon .


There is a growing literature describing efforts to integrate multimedia into surgical patient education .


This study aimed to assess the efficacy of an educational video tutorial on early learning of information specific to patients undergoing shoulder arthroscopy when it was used as an adjunct to the standard preoperative consultation .


This study was a surgeon-blinded , randomized controlled trial involving @ consecutive patients requiring shoulder arthroscopy .


After a preoperative consultation with an orthopaedic surgeon , patients were randomized in a @:@ ratio to either a control group or a treatment group .


The treatment group viewed a @-minute video , which covered the expected preoperative , intraoperative , and postoperative experience .


Immediately afterward , both groups completed a questionnaire measuring satisfaction and recall of information received .


All patients completed a second questionnaire at the first postoperative visit that assessed overall satisfaction with their experience .


Thirty-four patients were available for follow-up .


The video group ( N = @ ) answered @ % of the knowledge questions correctly , whereas the control group ( N = @ ) answered only @ % ( P = @ ) .


There was stronger agreement in the video group that the preoperative consultation contained an appropriate amount of information ( P = @ ) .


Postoperatively , there was agreement that the video was an effective preparation tool for all stages of the surgical experience .


However , there was no difference between the groups in satisfaction with their overall surgical experience .


Video can enhance patients ' operative experiences and improve their retained knowledge when it is used as an adjunct to the preoperative consultation .


Basic science , education methodology study , devices to improve learning .


Postoperative pulmonary complications are a burden for high-risk surgical patients with a risk of aspiration of subglottic secretions along the polyvinyl chloride cuff .


The introduction of a polyurethane cuff diminishes secretion leakage with a decreased rate of pneumonia .


The aim of the current analysis was to determine the time at which a polyurethane cuffed endotracheal tube might be advantageous to prevent aspiration in a setting of high-risk surgical patients .


The present investigation is based on published data obtained in postoperative cardiac surgical patients undergoing operation from @ to @ .


Cuff pressure was kept between @ and @ cmH@O intraoperatively and in the intensive care unit .


The current post hoc analysis determines ( @ ) the discriminatory cutoff value of intubation duration for predicting postoperative pneumonia and ( @ ) the potential factors associated with prolonged intubation .


Forty-three patients ( @ % ) were diagnosed with early postoperative pneumonia .


Receiver operating characteristics analysis revealed a cutoff value of @ hours for the duration of mechanical ventilation to discriminate patients with postoperative pneumonia .


A stepwise binary logistic regression analysis revealed that a polyvinyl chloride cuff was associated with a @-fold increased risk for prolonged intubation .


The current analyses provide evidence that among cardiac surgical patients , mechanical ventilation more than @ hours is associated with an increased likelihood of postoperative pneumonia .


To compare the effects of resistance training versus passive physical therapy on bone density in the metastatic bone during radiation therapy ( RT ) as combined treatment in patients with spinal bone metastases .


Secondly , to quantify pathological fractures after combined treatment .


In this randomized trial , @ patients were allocated from September @ until March @ into one of the two groups : resistance training ( group A ) or passive physical therapy ( group B ) with thirty patients in each group during RT. .


Bone density in metastatic and non-metastatic vertebral bone was assessed at baseline , @ and @ months after RT. .


Bone density in all metastases increased significantly by @ % ( IQR @-@ @ ) and @ % ( IQR @-@ @ ) after @ and @ months in group A ( both p < @ ) .


The bone density in group A was significantly increased compared to control group after @ and @months ( both p < @ , median @ ; IQR @-@ @ and median @ ; IQR -@ to @ ) .


The bone density data in group B showed no significant increase over the course of time ( p = @ , median @ , IQR @-@ @ and p = @ , median @ , IQR @-@ @ ) .


@ % of the patients in group A and @ % of the patients in group B had pathological fractures , no fracture was assigned to intervention , and no difference between groups after @ and @ months was observed ( p = @ and p = @ ) .


Our trial demonstrated that resistance training concomitant to RT can improve bone density in spinal bone metastases .


This combined treatment is effective , practicable , and without side effects for patients .


Importantly , the pathological fracture rate in the intervention group was not increased .


The results offer a rationale for future large controlled investigations to confirm these findings .


Female sexual dysfunction ( FSD ) is a common problem that may be encountered in the interruption of normal sexual functioning in the sexual response cycle .


Women with a pelvic floor disorder who scored low on the Female Sexual Function Index ( FSFI ) showed an improvement in their sexual life following treatment by vaginal electrical stimulation ( VES ) .


The aim of this trial was to evaluate the effectiveness of VES in women with FSD without a predominant pelvic floor disorder or urinary incontinence .


Forty-two women with FSD were randomly allocated to VES and placebo groups .


Pelvic floor muscle ( PFM ) assessment and the FSFI questionnaire were performed at baseline and after the completion of sessions .


VES treatment was administered using a vaginal probe .


The probe was inserted , and a medium-frequency ( @Hz ) alternating current was administered for a duty cycle of @ seconds on followed by a @-second rest .


Primary outcome measure was the improvement in FSFI score .


PFM assessments were performed according to the PERFECT scheme .


Total FSFI scores improved significantly in both the VES group and the control group .


Results show that in the VES group , there was an improvement in total score and FSFI domains that improved including arousal , desire , orgasm , and satisfaction .


Similarly , control group domains that improved were desire , arousal , and orgasm .


But there was no significant increase in satisfaction scores in the placebo group .


No significant changes in pain or lubrication domains were seen in either group .


Power , endurance , fast contractions , and repetitions were significantly improved in the VES group .


The lack of significant differences between the placebo and VES groups , except the satisfaction domain , puts into question the effectiveness of electrical stimulation as a monotherapy in treating primary FSD without pelvic floor disorder .


Muscle fatigue of the trunk extensor musculature plays a considerable role in chronic low back pain ( LBP ) .


The underlying physiology of fatigue is complex and not fully understood .


The Kinesio Taping ( KT ) supports damaged structures while allowing mobility and at the same time may influence some of the mechanisms associated with muscle fatigue such as blood flow and proprioception .


The aim of this study is to determine the influence of KT on the resistance to fatigue of the lumbar extensor musculature in a sample of young healthy subjects .


A randomized , controlled , doubled-blinded clinical trial was conducted .


Ninety nine healthy subjects were randomized in to the three arms of the study Kinesio Tape ( KT ) , placebo ( P ) and control ( C ) .


Directly after application of KT we measured lumbar extensor musculature endurance with the Biering-Sorensen test .


Subjects and researchers were blinded to the intervention .


Time achieved ( seconds ) was compared between groups with one-way ANOVA with confidence intervals of @ % .


There were significant differences between the time achieved in the KT group versus the control group ( p < @ ) .


The placebo group performed better than the control group but worse than the KT group , these were not significant in either case .


KT appears to improve the time to failure of the extensor muscle of the trunk obtained using the Biering-Sorensen test .


These findings suggest that KT influences processes that lead to muscle fatigue and that KT could be effective in the management of LBP .


To investigate the influence of different pressures of CO@ pneumoperitioneum on pathomorphism and function of intestines following laparoscopic gastrectomy ( LG ) .


Forty-eight gastric cancer patients were prospectively enrolled in the study .


Among them , @ patients scheduled for elective LG were randomly assigned to low pressure group ( LP ) , middle pressure ( MP ) , and high pressure group ( HP ) with @ cases in each group .


The CO@ pneumoperitoneum pressure was maintained at @-@ mmhg in LP , @-@ mmhg in MP , and @-@ mmhg in HP .


The control group was open gastrectomy group ( OG ) in @ cases .


The intestinal pathomorphism and level of plasma D-lactic acid before , during and after operation , and postoperative intestinal function of four groups were examined and compared .


There were no statistical differences in preoperative data among the four groups ( all P > @ ) .


LG group was associated with a lower rate of surgical complications than OG ( @ % vs. @ % , P < @ ) .


No obvious damage of intestinal mucosa was found in OG group .


Damage degree of intestinal mucosa after operation in LP , MP and HP groups was @-@ , @-@ , and @-@ respectively .


There was significant change in intestinal pathomorphism after operation in both HP and MP groups .


The levels of D-lactic acid before operation were not significantly different among all the four groups , but increased significantly in each group after operation ( all P < @ ) .


HP group had the highest level of plasma D-lactic acid and presented with delayed bowel sound return ( @ d ) , time to first flatus ( @ d ) , and intake ( @ d ) as compared to the other @ groups ( all P < @ ) .


Laparoscopic radical gastrectomy is safe and minimally invasive .


Higher pneumoperitoneal pressure is harmful to the recovery of intestinal mucosa and function .


Therefore the pneumoperitioneum pressure should be maintained as low as possible under clear visualization during operation .


To determine the effectiveness of a short educational video and simulation on improvement of ultrasound ( US ) image acquisition and interpretation skills .


Prospective , randomized study .


University medical center .


@ anesthesia residents and community anesthesiologists with varied ultrasound experience were randomized to teaching video with interactive simulation or sham video groups .


Participants were assessed preintervention and postintervention on their ability to identify the sciatic nerve and other anatomic structures on static US images , as well as their ability to locate the sciatic nerve with US on live models .


Pretest written test scores correlated with reported US block experience ( Kendall tau rank r = @ ) and with live US scanning scores ( r = @ ) .


The teaching video and simulation significantly improved scores on the written examination ( P < @ ) ; however , they did not significantly improve live US scanning skills .


A short educational video with interactive simulation significantly improved knowledge of US anatomy , but failed to improve hands-on performance of US scanning to localize the nerve .


To compare the rate of glove perforations and surgeon satisfaction when utilizing blunt surgical needles compared to conventional sharp surgical needles .


Patients undergoing Caesarean delivery were randomly assigned to the use of blunt or sharp surgical suture needles .


Surgical team members reported any known needlesticks or perforations of gloves and the primary surgeon completed a survey to gauge their satisfaction with the needles .


Glove perforation was assessed by suspending gloves and filling with water .


The chi-square test was used to assess categorical variables and the Mann-Whitney U-test was used to assess ordinal data .


A total @ patients were enrolled into the study .


There was no statistically significant difference in the rate of glove perforation per case between groups assigned to sharp ( @ % ) or blunt surgical needles ( @ % ) .


( RR @ , @ % CI @-@ @ ) .


There were significant differences in the surgeon satisfaction surveys , with surgeons in the sharp needle group being more satisfied with the tissue penetration of the needle ( p < @ ) , needle integrity ( p = @ ) , force to penetrate tissue ( p < @ ) and control of bleeding at the needle insertion site ( p = @ ) .


Surveys from surgeons in the blunt needle group showed a statistically significant improvement in the perceived safety profile of the blunt needles ( p < @ ) CONCLUSIONS : There was no significant difference in the rate of glove perforation between blunt and sharp surgical needles during Caesarean delivery .


Overall surgeons were more satisfied with the sharp surgical needles .


To estimate the effect of oral midazolam on patient pain and anxiety perception during first-trimester surgical abortion .


Between May and December @ , we conducted a randomized , double-blind , placebo-controlled trial .


Patients between @@/@ and @@/@ weeks of gestation received @ mg oral midazolam or placebo @-@ minutes before surgical abortion .


All patients received ibuprofen and a paracervical block .


We powered the study ( power = @ % ; significance level = @ ) to detect a @-mm difference in our two a priori primary outcomes of pain and anxiety with uterine aspiration on a @-mm visual analog scale .


Secondary outcomes were pain and anxiety at additional time points , memory , satisfaction , side effects , and adverse events .


Demographics were similar between groups ( placebo = @ , midazolam = @ ) .


Compared with those randomized to placebo , patients who received midazolam had significantly less anxiety preoperatively ( room entry : @ mm compared with @ mm , P < @ ; positioning : @ mm compared with @ mm , P = @ ) .


There was no difference in pain ( P = @ ) or anxiety ( P = @ ) during uterine aspiration or at other procedural time points .


A significantly greater number of patients in the midazolam group reported partial amnesia ( @/@ compared with @/@ , P = @ ) and dizziness ( @/@ compared with @/@ , P = @ ) .


Controlling for baseline differences , patients who received midazolam reported more postoperative sleepiness ( P < @ ) and less postoperative nausea ( P = @ ) .


There was no difference in overall satisfaction ( P = @ ) .


Although oral midazolam reduces preprocedural anxiety , it does not reduce pain or anxiety with uterine aspiration during first-trimester surgical abortions .


To determine whether the use of plasma rich in growth factors accelerates healing of the donor site in bone-tendon-bone anterior cruciate ligament ( ACL ) reconstruction ( patellar graft ) .


The use of the patellar graft presents post-operative problems such as anterior knee pain , which limits its use and leads to preference being taken for alternative grafts .


A double-blind , randomized , clinical trial was performed comparing two groups of patients who underwent ACL reconstruction using patellar tendon graft and comparing the use of plasma rich in growth factors at the donor site after graft harvest in terms of local regeneration by ultrasound assessment .


The plasma rich in growth factors group shows earlier donor site regeneration in comparison with the control group ( @months earlier ) , with significant differences in the first @months of the follow-up .


The application of plasma rich in growth factors shows accelerated tissue regeneration processes with respect to the control group .


This fact , together with the previously published with similar conclusions , can create a knowledge basis in order to set out new recovery guidelines following ACL reconstruction .


Therapeutic study , Level I.


Specific immunotherapy is the only treatment for the underlying allergic disease in patients with respiratory allergies .


The primary objective of this trial was to evaluate the efficacy and safety of two maintenance doses of immunologically enhanced , standardised quality ( SQ + ) grass subcutaneous immunotherapy ( SCIT ) -LSB- @,@ SQ + and @,@ SQ + ; AVANZ ( ) Phleum pratense ( ALK ) -RSB- compared with placebo .


This was a randomised , double-blind , placebo-controlled , phase II/III trial .


The primary evaluation was based on the combined rhinoconjunctivitis score during the entire grass pollen season .


Adult subjects with grass pollen-induced allergic rhinoconjunctivitis interfering with usual activities or sleep despite symptomatic medication use , were enrolled .


Four hundred and fifty subjects were randomised to receive either @,@ SQ + ( n = @ ) , @,@ SQ + ( n = @ ) or placebo ( n = @ ) .


The average grass pollen exposure was @ grains/m ( @ ) / day .


No statistically significant differences between the active groups and the placebo group were found for clinical endpoints ( p > @ ) .


Highly statistically significant ( p < @ ) increases in IgG@ and IgE-blocking factor were found for both active groups versus placebo .


The most frequently reported adverse events were mild-to-moderate local injection-site reactions ; events were generally more frequent with @,@ SQ + than with @,@ SQ + and placebo .


The most common adverse events leading to premature discontinuation from the trial were anaphylactic reactions ( one subject from the placebo group and five subjects from the @,@ SQ + group ) .


The inconclusive results were most probably influenced by a very low grass pollen season .


Other factors such as the extent of the pre-seasonal treatment could potentially have contributed .


The tolerability profile was acceptable for further development .


Pacing strategies have been reported to occur during continuous cyclical exercises .


However , currently no studies have examined if pacing takes place during repeated maximal voluntary muscle contractions ( MVCs ) .


Accordingly , the purpose of this study was to examine if informing subjects on the number of MVCs they would perform would affect force and root mean squared electromyography ( EMG ) , during similar fatiguing protocols .


Thirty well-trained male subjects completed three fatiguing protocols in a randomized order .


In the control condition participants were informed they would perform @ MVCs , and then completed all @ .


In the unknown condition they were not told how many MVCs they would perform , but were stopped after @ .


Lastly , in the deception condition they were initially told they would perform only @ MVCs , but after the @ contractions they were asked to perform a few more repetitions and were stopped after @ .


Compared to the unknown condition , subjects demonstrated greater forces ( p < @ , ES = @-@ @ , @-@ @ % ) and biceps EMG ( p < @ , ES = @ , @ % ) in the deception condition during the first six MVCs .


Additionally , under all conditions subjects applied greater forces in the last repetition ( # @ ) relative to the previous one ( # @ ) ( p < @ , ES = @-@ @ , @-@ @ % ) .


The anticipation of performing a certain number of MVCs led the subjects to utilize different pacing strategies .


The results also question the assumption that subjects followed the instruction to exert maximal effort during repeated MVCs .


To examine the concurrent and predictive associations between the number of steps taken per day and clinical outcomes in patients with fibromyalgia ( FM ) .


A total of @ adults with FM ( mean age @ years , @ % women ) who were enrolled in a randomized clinical trial wore a hip-mounted accelerometer for @ week and completed self-report measures of physical function ( Fibromyalgia Impact Questionnaire-Physical Impairment -LSB- FIQ-PI -RSB- , Short Form @ -LSB- SF-@ -RSB- health survey physical component score -LSB- PCS -RSB- , pain intensity and interference ( Brief Pain Inventory -LSB- BPI -RSB- ) , and depressive symptoms ( Patient Health Questionnaire-@ -LSB- PHQ-@ -RSB- ) as part of their baseline and followup assessments .


Associations of steps per day with self-report clinical measures were evaluated from baseline to week @ using multivariate regression models adjusted for demographic and baseline covariates .


Study participants were primarily sedentary , averaging @,@ @,@ steps per day .


Our findings demonstrate a linear relationship between the change in steps per day and improvement in health outcomes for FM .


Incremental increases on the order of @,@ steps per day were significantly associated with ( and predictive of ) improvements in FIQ-PI , SF-@ PCS , BPI pain interference , and PHQ-@ ( all P < @ ) .


Although higher step counts were associated with lower FIQ and BPI pain intensity scores , these were not statistically significant .


Step count is an easily obtained and understood objective measure of daily physical activity .


An exercise prescription that includes recommendations to gradually accumulate at least @,@ additional steps per day may result in clinically significant improvements in outcomes relevant to patients with FM .


Future studies are needed to elucidate the dose-response relationship between steps per day and patient outcomes in FM .


Self-care acupressure might be successful in treating menstrual pain , which is common among young women .


There is a need for comparative effectiveness research with stakeholder engagement in all phases seeking to address the needs of decision-makers .


Our aim was to design a study on the effectiveness of additional self-care acupressure for menstrual pain comparing usual care alone using different methods of stakeholder engagement .


The study was designed using multiple mixed methods for stakeholder engagement .


Based on the results of a survey and focus group discussion , a stakeholder advisory group developed the study design .


Stakeholder engagement resulted in a two-arm pragmatic randomized trial .


Two hundred and twenty women aged @ to @ years with menstrual pain will be included in the study .


Outcome measurement will be done using electronic questionnaires provided by a study specific mobile application ( App ) .


Primary outcome will be the mean pain intensity at the days of pain during the third menstruation after therapy start .


Stakeholder engagement helped to develop a study design that better serves the needs of decision makers , including an App as a modern tool for both intervention and data collection in a young target group .


The aim of the present randomized controlled trial was to determine the safety and efficacy of injectable demineralized bone matrix ( DBM ) gel combined with recombinant human bone morphogenetic protein-@ ( rhBMP-@ ) on alveolar ridge preservation after tooth extraction .


A total of @ patients were randomly assigned to either a test group ( n = @ ) or a control group ( n = @ ) .


In the test group , DBM , together with rhBMP-@ ( @ mg/mL ; rhBMP-@ / DBM ) was transplanted into the extraction sockets .


The control group received DBM alone .


The safety of rhBMP-@ / DBM was evaluated by oral examination , serum chemistry , and hematologic examination .


The radiographic changes in alveolar bone height and width were measured using computed tomography scans performed immediately after transplant and again @ months thereafter .


Healing was uneventful in all subjects , with no anticipated adverse events and no clinically significant changes in the serum chemistry and hematologic findings .


No meaningful immune response was found among the study groups .


No significant difference was found in the radiographic changes of alveolar bone height and width ( P > @ ) .


This new injectable biomaterial can be used easily and safely in clinical applications .


Sharing information with the team is critical in developing a shared mental model in an emergency , and fundamental to effective teamwork .


We developed a structured call-out tool , encapsulated in the acronym ` SNAPPI ' : Stop ; Notify ; Assessment ; Plan ; Priorities ; Invite ideas .


We explored whether a video-based intervention could improve structured call-outs during simulated crises and if this would improve information sharing and medical management .


In a simulation-based randomized , blinded study , we evaluated the effect of the video-intervention teaching SNAPPI on scores for SNAPPI , information sharing , and medical management using baseline and follow-up crisis simulations .


We assessed information sharing using a probe technique where nurses and technicians received unique , clinically relevant information probes before the simulation .


Shared knowledge of probes was measured in a written , post-simulation test .


We also scored sharing of diagnostic options with the team and medical management .


Anaesthetists ' scores for SNAPPI were significantly improved , as was the number of diagnostic options they shared .


We found a non-significant trend to improve information-probe sharing and medical management in the intervention group , and across all simulations , a significant correlation between SNAPPI and information-probe sharing .


Of note , only @ % of the clinically relevant information about the patient provided to the nurse and technician in the pre-simulation information probes was subsequently learnt by the anaesthetist .


We developed a structured communication tool , SNAPPI , to improve information sharing between anaesthetists and their team , taught it using a video-based intervention , and provide initial evidence to support its value for improving communication in a crisis .


Persistent pain after inguinal herniorrhaphy is a disabling condition with a lack of evidence-based pharmacological treatment options .


This randomized placebo-controlled trial investigated the efficacy of a capsaicin @ % cutaneous patch in the treatment of severe persistent inguinal postherniorrhaphy pain .


Forty-six patients with persistent inguinal postherniorrhaphy pain were randomized to receive either a capsaicin @ % patch or a placebo patch .


Pain intensity ( Numerical Rating Scale -LSB- NRS @-@ -RSB- ) was evaluated under standardized conditions ( at rest , during movement , and during pressure ) at baseline and at @ , @ and @ months after patch application .


Skin punch biopsies for intraepidermal nerve fiber density ( IENFD ) measurements were taken at baseline and @ month after patch application .


Quantitative sensory testing was performed at baseline and at @ , @ , and @ months after patch application .


The primary outcome was comparisons of summed pain intensity differences ( SPIDs ) between capsaicin and placebo treatments at @ , @ and @ months after patch application ( significance level P < @ ) .


The maximum difference in SPID , between capsaicin and placebo treatments , was observed at @ month after patch application , but the pain reduction was not significant ( NRS , mean difference -LSB- @ % CI -RSB- : @ -LSB- @ to @ -RSB- ; P = @ ) .


No differences in SPID between treatments were observed at @ and @ months after patch application .


Changes in IENFD on the pain side , from baseline to @ month after patch application , did not differ between capsaicin and placebo treatment : @ -LSB- -@ to @ -RSB- and @ -LSB- -@ to @ -RSB- fibers/mm , respectively ( P = @ ) .


No significant changes in sensory function , sleep quality or psychological factors were associated with capsaicin patch treatment .


The study did not demonstrate significant differences in pain relief between capsaicin and placebo treatment , although a trend toward pain improvement in capsaicin treated patients was observed @ month after patch application .


The study @ demonstrated significant improvements in progression-free survival ( PFS ) , objective response , and a nonsignificant trend toward increased overall survival ( OS ) with panitumumab-FOLFIRI versus FOLFIRI alone for second-line wild-type ( WT ) KRAS metastatic colorectal cancer ( mCRC ) .


Updated long-term data from a prespecified descriptive analysis are reported .


Patients receiving one prior mCRC treatment were randomly assigned ( @:@ ) to panitumumab ( @ mg/kg ) - FOLFIRI versus FOLFIRI every @ weeks .


Co-primary end points ( PFS and OS ) were prospectively analyzed by tumor KRAS status .


One thousand one hundred and eighty-six patients were randomly assigned .


In patients with WT KRAS tumors , panitumumab-FOLFIRI significantly improved PFS versus FOLFIRI -LSB- median @ versus @ months ; hazard ratio ( HR ) @ -LSB- @ % confidence interval ( CI ) @ , @ -RSB- ; P = @ -RSB- .


A trend toward longer OS was observed ( median @ versus @ months ; HR @ -LSB- @ % CI @ , @ -RSB- ; P = @ ) .


Response rates improved from @ % to @ % ( P < @ ) .


From post hoc analyses in patients receiving prior oxaliplatin-bevacizumab , panitumumab-FOLFIRI improved PFS ( median @ versus @ months ; HR @ -LSB- @ % CI @ , @ -RSB- ; P = @ ) .


PFS and OS appeared longer for worst-grade skin toxicity of @-@ , versus @-@ or FOLFIRI .


Safety results were as previously reported and consistent with the known toxicities with anti-epidermal growth factor receptor therapy .


These data confirm the primary efficacy and safety findings of this trial and support panitumumab-FOLFIRI as a second-line treatment of WT KRAS mCRC .


There is some evidence that individual-level job loss can lead to greater alcohol consumption and problems .


While other forms of economic loss were common during the recent recession , these are rarely investigated in studies of macroeconomic decline .


This study examined the relationship between types of economic loss in the @ to @ recession and alcohol outcomes , and whether this varied by gender and age .


Data are from the @ to @ U.S. National Alcohol Survey ( N = @,@ ) .


We used multivariable regression to estimate associations between economic loss and alcohol volume , monthly drunkenness , negative drinking consequences , and alcohol dependence in the overall sample and within gender and age groups ( @ to @ , @ to @ , @ + ) , controlling for demographic and alcohol history covariates .


In the overall sample , severe economic loss ( job or housing loss ) was positively associated with negative drinking consequences , alcohol dependence , and ( marginally ) drunkenness , whereas moderate loss ( loss of retirement savings , reduced work hours/wages , or trouble paying the rent/mortgage ) was unassociated with alcohol outcomes .


Important gender and age differences were observed .


Women reporting retirement loss , reduced hours/wages , and job loss consumed @ to @ % more alcohol than women unaffected by the recession , and men who experienced job loss and housing problems had increased risk for drunkenness , drinking consequences , and dependence .


Middle-aged Americans affected by partial or complete job loss and housing problems also had greater risk of drunkenness and alcohol-related problems , and older adults who lost retirement savings drank @ % more alcohol than their peers unaffected by the recession .


With the exception of negative drinking consequences , young adult alcohol outcomes were largely unrelated to recessionary loss .


This study highlights the adverse effects of recession-induced economic losses on alcohol use and problems in demographic subgroups .


As men and middle-aged Americans were at risk for multiple , adverse alcohol outcomes , these groups may warrant special alcohol screening and intervention efforts in future macroeconomic crises .


Estimated effects of breast-feeding on childhood health vary between studies , possibly due to confounding by baseline maternal and child characteristics .


Possible time-dependent confounding has received little consideration .


Our aim was to evaluate the impact of such confounding .


We estimated the relationship between cumulative exclusive breast-feeding up to @ months and wheezing , rash and body mass index ( BMI ) at @ months -LSB- in the Whistler cohort ( n = @ ) and PROBIT ( n = @,@ ) -RSB- , and wheezing , rash , asthma , hay fever , eczema , allergy and BMI at age @ years ( PROBIT ) .


We adjusted for time-dependent confounding by weight , length , rash , respiratory illness and day care attendance using marginal structural models ( MSMs ) .


Weight and day care attendance appeared potential time-dependent confounders , since these predicted breast-feeding status and were influenced by previous breast-feeding .


However , adjustment for time-dependent confounders did not markedly change the estimated associations .


For example , in PROBIT the adjusted increase in BMI at @ months per @-month increase in exclusive breast-feeding was @ ( @ % CI -@ to @ ) using logistic regression and -@ ( @ % CI -@ to -@ ) using MSM .


In Whistler , these estimates were each -@ ( @ % CI -@ to @ ) .


In two cohort studies , there was little evidence of time-dependent confounding by weight , length , rash , respiratory illness or day care attendance of the effects of breast-feeding on early childhood health .


Cryoballoon isolation of the pulmonary veins ( PVI ) is an effective and safe method in the treatment of patients with paroxysmal atrial fibrillation ( PAF ) .


The circular mapping catheter Achieve ( Medtronic Inc. , Minneapolis , USA ) can be introduced into the pulmonary vein ( PV ) through the inner lumen of the balloon catheter , allowing online mapping of the PV electrograms during ablation .


We prospectively compared the accuracy of this catheter in both available sizes to a standard circular mapping catheter ( SCMC ) in order to determine bidirectional PV block .


Patients with symptomatic PAF underwent cryoballoon ablation using either the Achieve @-mm catheter ( group @ , @ patients ) or the Achieve @ mm ( group @ , @ patients ) .


PV potentials were recorded using Achieve before , during , and after ablation , and exit block was obtained by pacing from inside the PV .


Accuracy of PV potential detection was controlled by a SCMC before and after ablation .


Rate of PV which could be isolated exclusively using the Achieve as guidewire was @ % ( @/@ ) in group @ and @ % ( @/@ ) in group @ .


Online signal recording during ablation was possible in @ and @ % of PV ( p = @ ) , respectively .


Final Achieve diagnosis was accurate in @/@ ( @ % ) of the PVs and @/@ ( @ % ) of patients in group @ and @/@ ( @ % ) of PV and @/@ ( @ % ) of patients in group @ .


Stand-alone mapping using Achieve @ mm resulted in a significant lack of diagnostic accuracy .


Achieve @ mm provided excellent diagnostic accuracy comparable to a SCMC and should be preferentially used .


The aim of this study was to investigate the effect of magnesium administered before induction on the hemodynamic response and QT dispersion ( QTd ) related with intubation in hypertensive patients and to compare it with lidocaine .


Patients with essential hypertension who were under @ years old , scheduled for elective surgery with a Mallampati score of I-II were included in the study .


Patients were randomly divided into three groups ; group M ( n = @ ) received magnesium sulfate , group L was prescribed lidocaine , and group C ( control group ) received saline .


Standard @-lead ECG readings were taken before the induction of anesthesia and at the first and fifth minutes following intubation .


There were no statistically significant differences between the groups in terms of age , sex and demographic characteristics .


There was no significant difference in the QT interval values before induction and @ minutes after intubation in all groups .


In group M , QTd values were significantly lower at the first and fifth minutes than before induction .


There were no statistically significant differences in QTd values at different times in group L and group C.


QTd is not increased during tracheal intubation in hypertensive patients so there is no need for magnesium sulfate for these patients .


But as QTd has been shown to increase during tracheal intubation for coronary artery disease patients , magnesium sulfate might be useful for those patients although future studies are required to confirm this statement .


Cervical cancer screening coverage remains insufficient in most countries .


Our objective was to assess whether in-home vaginal self-sampling with a dry swab for high-risk human papillomavirus ( HR-HPV ) testing is effective and cost-effective in increasing participation in cervical cancer screening .


In March @ , @ unscreened women aged @-@ years , living in a French region covered by a screening programme , who had not responded to an initial invitation to have a Pap smear were equally randomised to three groups : ` no intervention ' ; ` recall ' , women received a letter to have a Pap smear ; and ` self-sampling ' , women received a self-sampling kit to return to a centralised virology laboratory for PCR-based HPV testing .


Participation was higher in the ` self-sampling ' than in the ` no intervention ' group ( @ % vs @ % , P < @ ; OR @ ) and ` recall ' group ( @ % , P < @ ; OR @ ) .


In the ` self-sampling ' group , @ used the self-sampling kit ; for @ of these women with positive HR-HPV test results , @ had the recommended triage Pap smear .


The ICER per extra screened woman was @ -LSB- euro -RSB- and @ -LSB- euro -RSB- for the ` recall ' and ` self-sampling ' groups , respectively , relative to the ` no intervention ' group .


Offering an in-home , return-mail kit for vaginal self-sampling with a dry swab is more effective and cost-effective than a recall letter in increasing participation in cervical cancer screening .


Chronic plantar fasciitis is a common orthopedic condition that can prove difficult to successfully treat .


In this study , autologous platelet-rich plasma ( PRP ) , a concentrated bioactive blood component rich in cytokines and growth factors , was compared to traditional cortisone injection in the treatment of chronic cases of plantar fasciitis resistant to traditional nonoperative management .


Forty patients ( @ females and @ males ) with unilateral chronic plantar fasciitis that did not respond to a minimum of @ months of standardized traditional nonoperative treatment modalities were prospectively randomized and treated with either a single ultrasound guided injection of @ cc PRP or @ mg DepoMedrol cortisone .


American Orthopedic Foot and Ankle Society ( AOFAS ) hindfoot scoring was completed for all patients immediately prior to PRP or cortisone injection ( pretreatment = time @ ) and at @ , @ , @ , and @ months following injection treatment .


Baseline pretreatment radiographs and MRI studies were obtained in all cases to confirm the diagnosis of plantar fasciitis .


The cortisone group had a pretreatment average AOFAS score of @ , which initially improved to @ at @ months posttreatment but decreased to @ at @ months , then dropped to near baseline levels of @ at @ months , and continued to decline to a final score of @ at @ months .


In contrast , the PRP group started with an average pretreatment AOFAS score of @ , which increased to @ at @ months , remained elevated at @ at @ and @ months , and had a final score of @ at @ months .


PRP was more effective and durable than cortisone injection for the treatment of chronic recalcitrant cases of plantar fasciitis .


Level I , prospective randomized comparative series .


The optimal design for a cemented femoral stem remains a matter of debate .


Over time , the shape , surface finish and collar have all been modified in various ways .


A clear consensus has not yet emerged regarding the relative merits of even the most basic design features of the stem .


We undertook a prospective randomised trial comparing surface finish and the effect of a collar on cemented femoral component subsidence , survivorship and clinical function .


One hundred and sixty three primary total hip replacement patients were recruited prospectively and randomised to one of four groups to receive a cemented femoral stem with either a matt or polished finish , and with or without a collar .


At two years , although there was a trend for increased subsidence in the matt collarless group , this was not statistically significant ( p = @ ) .


At a mean of @ years follow-up , WOMAC scores for the surviving implants were good , ( Range of means @-@ ) without significant differences .


Using revision or radiographic loosening as the endpoint , survivorship of the entire cohort was @ % at @ yrs , ( CI @-@ % ) .


There were no significant differences in survivorship between the two groups with polished stems or the two groups with matt stems .


A comparison of the two collarless stems demonstrated a statistically significant difference in survivorship between polished ( @ % ) and matt ( @ % ) finishes ( p = @ ) .


In the presence of a collar , surface finish did not significantly affect survivorship or function .


Between the two collarless groups a polished surface conferred an improved survivorship .


Despite the availability and demonstrated effectiveness of intensive combination treatment strategies ( ICTS ) for early rheumatoid arthritis ( RA ) , a discrepancy seems to exist between theoretical evidence and actual prescription in daily practice .


The purpose of this study was to explore and identify the factors influencing the prescription of ICTS .


This study involved rheumatologists and nurses participating in the Care for Rheumatoid Arthritis ( CareRA ) trial , a multicentre randomized controlled trial ( RCT ) comparing different ICTS for early RA with conventional disease-modifying anti-rheumatic drugs ( DMARDs ) plus step-down glucocorticoids ( GCs ) .


A qualitative study was carried out using individual semi-structured interviews .


Each interview was recorded , transcribed literally , and analysed thematically .


In addition , observations at outpatient clinics were used to clarify the interpretation of the results .


We interviewed @ rheumatologists and six nurses and observed five outpatient visits .


Identified facilitators included available scientific evidence , personal faith in treatment strategy , staff support , and low treatment costs .


Rheumatologists had no doubts about the value of methotrexate ( MTX ) but some questioned the value of combination strategy , others the effectiveness and/or the dosage of individual compounds .


Additional barriers for prescribing ICTS included need for patient education , fear for patients ' preconceptions , concerns about applicability to the individual patient , difficulties with breaking routine , interference with organizational structures and processes , time constraints , and lack of financial support .


A heterogeneous set of factors highlights the complexity of prescribing ICTS for early RA in daily clinical practice .


Future improvement strategies should stimulate the facilitators while at the same time addressing the barriers .


The generalizability of these findings to other health care systems needs further examination .


Millions of women are afflicted with stress urinary incontinence .


Urinary incontinence is mentioned as one of the geriatric syndromes , together with pressure ulcers , functional decline , falls , and low self-esteem .


The aim of the present study was to determine the effect of pelvic muscle exercises on urinary incontinency and self - esteem of elderly females with stress urinary incontinency in Shiraz , Iran , @ .


In this interventional study , @ old females aged @-@ years were chosen among the members of Jahandidegan center , and they were asked to sign the informed consent form and complete the demographic questionnaire .


Then , Quid questionnaire was used for choosing the type of incontinence in the elderly females .


Next , the participants completed the ICIQ and self-esteem questionnaires .


Then , they were randomly assigned to case and control groups .


Each participant took part in @ training classes .


Finally , the subjects filled the ICIQ and self-esteem questionnaires before and @ months after the intervention .


The results is shown that after the intervention , ICIQ score has a significant difference between the two groups ( P = @ ) .


Also , after the treatment , self-esteem average scores of studied unit indicated a significant statistical difference in experimental group .


In other words , the training sessions improved the score of self-esteem in the experimental group ( P < @ ) versus control group ( P = @ ) .


Pelvic muscle exercises were an empowerment mechanism for incontinent women in improving their quality of life and self-esteem , so recommended that such these exercising programs be used in elderly health care centers as a factor to improve health promotion of elderlies ` that are suffering from urinary incontinence .


Nutritional risk is relatively common in community-dwelling older people .


To objective of this study was to evaluate the effects of individual dietary counseling as part of a Comprehensive Geriatric Assessment on nutritional status among community-dwelling people aged @ years or older .


Data were obtained from a subpopulation of participants in the population-based Geriatric Multidisciplinary Strategy for the Good Care of the Elderly ( GeMS ) intervention study in @ to @ .


In the present study , the population consist @ persons at risk of malnutrition in the year @ in an intervention ( n = @ ) and control group ( n = @ ) .


Nutritional status , body weight , body mass index , serum albumin were performed at the beginning of the study and at a two-year follow-up .


The nutritional screening was performed using the Mini Nutritional Assessment ( MNA ) test .


A increase in MNA scores ( @ @ % confidence interval -LSB- CI -RSB- : @ to @ ) and in serum albumin ( @ g/L , @ % CI : @ to @ g/L ) were a significant difference between the groups .


Nutritional intervention , even dietary counseling without nutritional supplements , may improve nutritional status .


The purpose of this study was to evaluate whether posterior cruciate ligament reconstruction with the double-bundle ( DB ) technique improved stability of the knee compared with the single-bundle ( SB ) technique .


This prospective study included @ patients who were randomized to undergo posterior cruciate ligament reconstruction by use of tibialis anterior grafts with either the SB technique ( @ patients ) or DB technique ( @ patients ) .


The group assignment was concealed before allocation with the use of sealed envelopes .


Posterior stability was evaluated with the KT-@ arthrometer ( MEDmetric , San Diego , CA ) , and clinical outcomes were assessed with the Lysholm score , Tegner activity score , and International Knee Documentation Committee score ( both objective and subjective ) .


There were @ patients in the SB group and @ patients in the DB group with a minimum follow-up period of @ years .


No differences were found between the @ groups regarding patient demographic data and the duration from injury to operation ( P > @ ) .


The Lysholm score was @ @ ( range , @ to @ ) in the SB group and @ @ ( range , @ to @ ) in the DB group , and there was no significant difference between the @ groups ( P = @ ) .


The Tegner activity score improved significantly to @ @ ( range , @ to @ ) in the SB group and @ @ ( range , @ to @ ) in the DB group .


The side-to-side difference in posterior translation decreased to @ @ mm ( range , @ to @ mm ) in the SB group and @ @ mm ( range , @ to @ mm ) in the DB group , and there was a significant difference between the @ groups ( P < @ ) .


According to the International Knee Documentation Committee ( both objective and subjective ) , the DB group had a better grade distribution ( P < @ ) and had a statistically higher grade ( @ @ ; range , @ to @ ) than the SB group ( @ @ ; range , @ to @ ) ( P < @ ) .


Although both techniques resulted in similar patient satisfaction as measured by outcome assessment , the DB procedure significantly improved knee stability .


Level II , lesser-quality randomized controlled trial .


Pedometer-based programs have elicited increased walking behaviors associated with improvements in blood pressure in sedentary/low active postmenopausal women , a population at increased risk of cardiovascular disease .


Such programs typically encourage increasing the volume of physical activity with little regard for its intensity .


Recent advances in commercially available pedometer technology now permit tracking of both steps/day and time in moderate ( or greater ) intensity physical activity on a daily basis .


It is not known whether the dual message to increase steps/day while also increasing time spent at higher intensity walking will elicit additional improvements in blood pressure relative to a message to only focus on increasing steps/day .


The purpose of this paper is to present the rationale , study design , and protocols employed in WalkMore , a @-arm @-month blinded and randomized controlled trial ( RCT ) designed to compare the effects of two community pedometer-based walking interventions ( reflecting these separate and combined messages ) relative to a control group on blood pressure in sedentary/low active post-menopausal women , a population at increased risk of cardiovascular disease .


@ sedentary/low active post-menopausal women ( @-@years of age ) will be randomly assigned ( computer-generated ) to @ of @ groups : A ) @,@ steps/day ( with no guidance on walking intensity/speed/cadence ; BASIC intervention , n = @ ) ; B ) @,@ steps/day and at least @minutes in moderate intensity ( i.e. , a cadence of at least @ steps/min ; ENHANCED intervention , n = @ ) ; or a Control group ( n = @ ) .


An important strength of the study is the strict control and quantification of the pedometer-based physical activity interventions .


The primary outcome is systolic blood pressure .


Secondary outcomes include diastolic blood pressure , anthropometric measurements , fasting blood glucose and insulin , flow mediated dilation , gait speed , and accelerometer-determined physical activity and sedentary behavior .


This study can make important contributions to our understanding of the relative benefits that walking volume and/or intensity may have on blood pressure in a population at risk of cardiovascular disease .


Cognitive behavioral therapy ( CBT ) and U.S. Food and Drug Administration ( FDA ) - recommended pharmacologic treatments ( RPTs ; pregabalin , duloxetine , and milnacipran ) are effective treatment options for fibromyalgia ( FM ) syndrome and are currently recommended by clinical guidelines .


We compared the cost-utility from the healthcare and societal perspectives of CBT versus RPT ( combination of pregabalin + duloxetine ) and usual care ( TAU ) groups in the treatment of FM .


The economic evaluation was conducted alongside a @-month , multicenter , randomized , blinded , parallel group , controlled trial .


In total , @ FM patients from @ general practices in Zaragoza ( Spain ) were randomized to CBT ( n = @ ) , RPT ( n = @ ) , or TAU ( n = @ ) .


The main outcome measures were Quality-Adjusted Life Years ( QALYs , assessed by using the EuroQoL-@D questionnaire ) and improvements in health-related quality of life ( HRQoL , assessed by using EuroQoL-@D visual analogue scale , EQ-VAS ) .


The costs of healthcare use were estimated from patient self-reports ( Client Service Receipt Inventory ) .


Cost-utility was assessed by using the net-benefit approach and cost-effectiveness acceptability curves ( CEACs ) .


On average , the total costs per patient in the CBT group ( @,@ ) were significantly lower than those in patients receiving RPT ( @,@ ) or TAU ( @,@ ) .


Patients receiving CBT reported a higher quality of life ( QALYs and EQ-VAS scores ) ; the differences between groups were significant only for EQ-VAS .


From a complete case-analysis approach ( base case ) , the point estimates of the cost-effectiveness ratios resulted in dominance for the CBT group in all of the comparisons performed , by using both QALYs and EQ-VAS as outcomes .


These findings were confirmed by bootstrap analyses , net-benefit curves , and CEACs .


Two additional sensitivity analyses ( intention-to-treat analysis and per-protocol analysis ) indicated that the results were robust .


The comparison of RPT with TAU yielded no clear preference for either treatment when using QALYs , although RPT was determined to be more cost-effective than TAU when evaluating EQ-VAS .


Because of lower costs , CBT is the most cost-effective treatment for adult FM patients .


Implementation in routine medical care would require policymakers to develop more-widespread public access to trained and experienced therapists in group-based forms of CBT .


Phosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients .


Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels .


@-week , open-label , phase @ , randomized , controlled trial for safety-profile assessment .


Maintenance dialysis patients with serum phosphorus levels @ mg/dL after washout of prior phosphate binders .


@:@ randomization to ferric citrate or active control ( sevelamer carbonate and/or calcium acetate ) .


Changes in mineral bone disease , protein-energy wasting/inflammation , and occurrence of adverse events after @ year .


Serum calcium , intact parathyroid hormone , phosphorus , aluminum , white blood cell count , percentage of lymphocytes , serum urea nitrogen , and bicarbonate .


There were @ participants randomly assigned to ferric citrate , and @ , to active control .


Groups were well matched .


For mean changes from baseline , phosphorus levels decreased similarly in the ferric citrate and active control groups ( -@ -LSB- SD -RSB- vs -@ mg/dL , respectively ; P = @ ) ; serum calcium levels increased similarly in the ferric citrate and active control groups ( @ vs @ mg/dL ; P = @ ) .


Hypercalcemia occurred in @ participants receiving calcium acetate .


Parathyroid hormone levels decreased similarly in the ferric citrate and active control groups ( -@ vs -@ pg/mL ; P = @ ) .


Serum albumin , bicarbonate , serum urea nitrogen , white blood cell count and percentage of lymphocytes , and aluminum values were similar between ferric citrate and active control .


Total and low-density lipoprotein cholesterol levels were lower in participants receiving sevelamer than those receiving ferric citrate and calcium acetate .


Fewer participants randomly assigned to ferric citrate had serious adverse events compared with active control .


Open-label study , few peritoneal dialysis patients .


Ferric citrate was associated with similar phosphorus control compared to active control , with similar effects on markers of bone and mineral metabolism in dialysis patients .


There was no evidence of protein-energy wasting/inflammation or aluminum toxicity , and fewer participants randomly assigned to ferric citrate had serious adverse events .


Ferric citrate is an effective phosphate binder with a safety profile comparable to sevelamer and calcium acetate .


We report detailed safety analyses by geographic region from the phase III study CLEOPATRA with pertuzumab , trastuzumab , and docetaxel in patients with human epidermal growth factor receptor @ ( HER@ ) - positive first-line metastatic breast cancer .


Patients received pertuzumab/placebo at @ mg in cycle @ and @ mg in subsequent cycles , and trastuzumab at @ mg/kg in cycle @ and @ mg/kg in subsequent cycles ; docetaxel was initiated at @ mg/m ( @ ) .


All study drugs were given intravenously , @ times weekly .


Docetaxel dose reductions below @ mg/m ( @ ) were more common in patients from Asia ( @ % ) than other regions ( @ % ) ; docetaxel dose escalations to @ mg/m ( @ ) were less frequent in Asia ( @ % ) than other regions ( @ % ) .


Rates of edema ( @ % and @ % for Asia and other regions , respectively ) , myalgia ( @ % , @ % ) , nail disorder ( @ % , @ % ) , febrile neutropenia ( @ % , @ % ) , upper respiratory tract infection ( @ % , @ % ) , decreased appetite ( @ % , @ % ) , and rash ( @ % , @ % ) were at least twice as high in Asia as in other regions .


Adverse events did not result in a reduction in the median number of study treatment cycles administered in patients from Asia .


Efficacy analyses per region showed hazard ratios similar to those of the whole intention-to-treat ( ITT ) population for progression-free survival ( ITT : @ ; Asia : @ ; other regions : @ ) and overall survival ( ITT : @ ; Asia : @ ; other regions : @ ) .


Despite a higher proportion of docetaxel dose reductions in patients from Asia , survival benefits were comparable between regions .