Using intention to treat approach , repeated measures analyses were employed to test whether the outcomes differed significantly : ( @ ) between visits @ and @ within each group and ( @ ) between each intervention group and the control group over time ( an interaction ) .


Between visits @ and @ , mean anxiety and behavior scores decreased significantly by @ points ( P = @ ) for subjects within groups C and D. Significant changes were not observed within groups A and B. Mean anxiety and behavior scores did not differ significantly between groups over time , although group A versus C pairwise comparisons showed a trend toward significance ( P = @ ) .


These findings suggest that certain electronic screen media technologies may be useful tools for reducing fear and uncooperative behaviors among children with ASD undergoing dental visits .


Further studies are needed to assess the efficacy of these strategies using larger sample sizes .


Findings from future studies could be relevant for nondental providers who care for children with ASD in other medical settings .


Increasing chest compression rate during cardiopulmonary resuscitation can affect the workload and , ultimately , the quality of chest compression .


This study examines the effects of compression at the rate of as-fast-as-you-can on cardiopulmonary resuscitation ( CPR ) performance .


A crossover , randomized-to-order design was used .


Each participant performed chest compressions without ventilation on a manikin with @ compression rates : @ per minute ( @-cpm ) and `` push as-fast-as you-can '' ( PF ) .


The participants performed chest compressions at a rate of either @-cpm or PF and subsequently switched to the other after a @-minute rest .


Forty-two CPR-qualified nonprofessionals voluntarily participated in the study .


During the PF session , the rescuers performed CPR with higher compression rates ( @ vs @ cpm ) , more compressions ( @ vs @ per @ minutes ) , and more duty cycles ( @ % vs @ % ) , but a lower percentage of effective compressions ( @ % vs @ % ) and a lower compression depth ( @ vs @ mm ) than they did during the @-cpm session .


The CPR quality deteriorated in numbers and percentile of effective compression since the third minute in the PF session and the fourth minute in the @-cpm session .


The percentile of compressions with adequate depth in the @-cpm sessions was higher than that in the PF sessions during the second , third , and fourth minutes of CPR .


Push-fast technique showed a significant decrease in the percentile of effective chest compression compared with the @-cpm technique during the @-minute hand-only CPR .


The PF technique exhibited a trend toward increased fatigue in the rescuers , which can result in early decay of CPR quality .


Long-term management of chronic conditions , such as atrial fibrillation ( AF ) , require frequent interactions with the healthcare systems .


The multinational EUropean Patient Survey in Atrial Fibrillation ( EUPS-AF ) was conducted to investigate patient satisfaction with AF management in different of five European healthcare systems at a time of changing treatment paradigms for stroke prophylaxis , prior to the advent of newer oral anticoagulants .


Adults ( > @ years ) were recruited at random from the total populations of France , Germany , Italy , Spain and the UK using a randomized telephone dialling system .


At least @ respondents per country reporting to have a diagnosis of AF or receiving oral anticoagulation therapy for suspected AF or to have a heart rhythm disturbance completed a structured telephone interview .


Most respondents were satisfied with their treatment for AF over the previous @ months , with @ % ( n = @ ) rating their care as good or better .


Suboptimal clinical practices , however , were identified in several key areas .


Coordination of primary and secondary care and a lack of patient engagement and support were particular issues , especially for those patients likely to have extensive contact with their healthcare system .


In the context of Europe-wide guidelines for management of AF , most patients with AF were satisfied with their care , but for a greater proportion of patients , some aspects are unsatisfactory .


Patient-centred surveys , such as the EUPS-AF , are crucial for understanding the factors that contribute to patient satisfaction and compliance with long-term treatment for chronic conditions .


Isovolemic anemia ( decrease in hemoglobin concentration with normal or even increased blood volume ) after gastric cancer surgery may negatively influence short - and long-term outcomes .


Therefore correction of isovolemic postoperative anemia is supposed to be beneficial .


This prospective randomized placebo-controlled multicenter trial is designed to evaluate the efficacy of ferric carboxymaltose administration with the primary end point of successful hemoglobin level increase by @ g/dl at @ weeks after randomization .


Gastric cancer patients after oncologic resection and postoperative hemoglobin level@ g/dl to < @ g/dl at postoperative days @ to @ will be eligible for trial inclusion .


After randomization , @ patients ( @ per group ) are going to be subjected either to administration of ferric carboxymaltose ( treatment group ) or normal ( @ % ) saline ( placebo group ) .


Patients will be blinded to the intervention .


Patients will undergo evaluation for hemoglobin level , hematology and quality of life assessment @ and @ weeks after randomization .


Correction of isovolemic postoperative anemia in gastric cancer patients after oncologic resection is considered to be beneficial .


Administration of ferric carboxymaltose is considered to be superior to placebo for anemia correction without the possible risks of red blood cell transfusion .


Further , improved quality of life for patients with quick recovery of hemoglobin levels is expected .


Hyperandrogenism and inflammation are related in polycystic ovary syndrome ( PCOS ) .


Hyperandrogenemia can induce inflammation in reproductive-age women , but the mechanism for this phenomenon is unclear .


We examined the in vivo and in vitro effects of hyperandrogenism on mononuclear cell ( MNC ) - derived androgen receptor ( AR ) status and TNF release .


This study combined a randomized , controlled , double-blind protocol with laboratory-based cell culture experiments .


This work was performed in an academic medical center .


Lean , healthy , reproductive-age women were treated with @ mg of dehydroepiandrosterone ( DHEA ) or placebo ( n = @ subjects each ) for @ days and also provided untreated fasting blood samples ( n = @ subjects ) for cell culture experiments .


AR mRNA content and TNF release were measured before and after DHEA administration in the fasting state and @ hours after glucose ingestion .


TNF release in the fasting state was also measured in cultured MNCs exposed to androgens with or without flutamide preincubation .


At baseline , subjects receiving DHEA or placebo exhibited no significant difference in androgens and TNF release from MNCs before and after glucose ingestion .


Compared with placebo , DHEA administration raised levels of T , androstenedione , and DHEA sulfate , and increased MNC-derived AR mRNA content and TNF release in the fasting state and in response to glucose ingestion .


Compared with MNC exposure to baseline concentrations of DHEA ( @ ng/dL ) or T ( @ ng/dL ) , the absolute change in TNF release increased after exposure to T concentrations of @ and @ ng/dL and a DHEA concentration of @ ng/dL .


Preincubation with flutamide reduced the TNF response by @ % across all T concentrations .


Androgen excess in vivo and in vitro comparable to what is present in PCOS increases TNF release from MNCs of lean healthy reproductive-age women in a receptor-dependent fashion .


Hyperandrogenemia activates and sensitizes MNCs to glucose in this population .


Drug-coated balloons ( DCBs ) have shown promise in improving the outcomes for patients with peripheral artery disease .


We compared a paclitaxel-coated balloon with percutaneous transluminal angioplasty ( PTA ) for the treatment of symptomatic superficial femoral and popliteal artery disease .


The IN.PACT SFA Trial is a prospective , multicenter , single-blinded , randomized trial in which @ patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a @:@ ratio to treatment with DCB or PTA .


The primary efficacy end point was primary patency , defined as freedom from restenosis or clinically driven target lesion revascularization at @ months .


Baseline characteristics were similar between the @ groups .


Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were @ @ and @ @ cm ( P = @ ) and @ % and @ % ( P = @ ) , respectively .


DCB resulted in higher primary patency versus PTA ( @ % versus @ % ; P < @ ) .


The rate of clinically driven target lesion revascularization was @ % in the DCB arm in comparison with @ % in the PTA arm ( P < @ ) .


There was a low rate of vessel thrombosis in both arms ( @ % after DCB and @ % after PTA -LSB- P = @ -RSB- ) .


There were no device - or procedure-related deaths and no major amputations .


In this prospective , multicenter , randomized trial , DCB was superior to PTA and had a favorable safety profile for the treatment of patients with symptomatic femoropopliteal peripheral artery disease .


We investigated the effect of Nitrous Oxide ( N@O ) on controlled hypotension in low-flow isoflurane-dexmedetomidine anesthesia in terms of hemodynamics , anesthetic consumption , and costs .


We allocated forty patients randomly into two equal groups .


We then maintained dexmedetomidine infusion ( @ g.kg-@ .


min-@ ) for @ minutes .


Next , we continued it until the last @ minutes of the operation at a dose of @ g.kg ( -@ ) .


hour ( -@ ) .


We administered thiopental ( @-@ mg .


kg ( -@ ) ) and @-@ @ mg.kg ( -@ ) vecuronium bromide at induction for both groups .


We used isoflurane ( @ % ) for anesthesia maintenance .


Group N received a @ % O@-N@O mixture and Group A received @ % O - air mixture as carrier gas .


We started low-flow anesthesia ( @ L.min ( -@ ) ) after a @-minute period of initial high flow ( @ L.min ( -@ ) ) .


We recorded values for blood pressure , heart rate , peripheral O@ saturation , inspiratory isoflurane , expiratory isoflurane , inspiratory O@ , expiratory O@ , inspiratory N@O , expiratory N@O , inspiratory CO@ , CO@ concentration after expiration , Minimum Alveolar Concentration .


In addition , we determined the total consumption rate of fentanyl , dexmedetomidine and isoflurane as well as bleeding .


In each group the heart rate decreased after dexmedetomidine loading .


After intubation , values were higher for Group A at one , three , five , @ , and @ minutes .


After intubation , the patients reached desired hypotension values at minute five for Group N and at minute @ for group A. MAC values were higher for Group N at minute one , three , five , @ , and @ ( p < @ ) .


FiO@ values were high between minute five and @ for Group A , while at minute @ Group N values were higher ( p < @ ) .


Fi Iso ( inspiratuvar isofluran ) values were lower in Group N at minute @ and @ ( p < @ ) .


By using dexmedetomidine instead of nitrous oxide in low flow isoflurane anesthesia , we attained desired MAP levels , sufficient anesthesia depth , hemodynamic stability and safe inspiration parameters .


Dexmedetomidine infusion with medical air-oxygen as a carrier gas represents an alternative anesthetic technique .


To examine whether self-efficacy mediated the effect of the Home-based Post-Hip Fracture Rehabilitation program on activity limitations in older adults after hip fracture and whether the mediating effect was different between sex and age groups .


Randomized controlled trial .


Community .


Participants with hip fracture ( N = @ ; mean age SD , @ y ) were randomly assigned to intervention ( n = @ , @ % ) and attention control ( n = @ , @ % ) groups .


The @-month intervention , the Home-based Post-Hip Fracture Rehabilitation , is a functionally oriented , home-based exercise program .


Data were collected at baseline , postintervention ( @mo ) , and follow-up ( @mo ) .


Activity Measure for Post-Acute Care .


The mediating effect of the Home-based Post-Hip Fracture Rehabilitation program on Basic Mobility function through self-efficacy for exercise was significant at @ months ( indirect = @ ) .


Similarly , the mediating effect of the intervention on Daily Activity function through self-efficacy for exercise was significant at @ months ( indirect = @ ) .


In subgroup analyses , the mediating effect was significant at @ months in the younger group ( age , @y ) in comparison to the older group and was significant in women in comparison to men .


Self-efficacy may play a partial mediating role in the effect on some longer-term functional outcomes in the Home-based Post-Hip Fracture Rehabilitation intervention .


The results suggest that program components that target self-efficacy should be incorporated in future hip fracture rehabilitation interventions .


Age and sex of the targeted participants may also need to be considered when developing interventions .


Albinterferon is a fusion of albumin and interferon-@b developed to improve the pharmacokinetics , convenience , and potential efficacy of interferon - for the treatment of chronic hepatitis infections .


This open-label , randomized , active-controlled , multicenter study investigated the safety and efficacy of albinterferon in patients with chronic hepatitis B virus ( HBV ) infection who were e-antigen ( HBeAg ) positive .


One hundred and forty-one patients received one of four albinterferon doses/regimens or pegylated-interferon-@a .


Primary efficacy outcomes were changes in serum HBeAg and antibody , HBV-DNA , and alanine aminotransferase .


Principal safety outcomes were changes in laboratory values , pulmonary function , and adverse events .


The study was prematurely terminated as phase III trials in hepatitis C infection indicated noninferior efficacy but inferior safety compared with pegylated-interferon-@a .


Here , all treatment groups had a significant reduction in HBV-DNA from baseline .


Reductions in HBV-DNA were not significantly different , except the @g every @ weeks albinterferon dose which was inferior compared with pegylated-interferon-@a .


The serum alanine aminotransferase levels decreased in all arms .


The per-patient incidence of adverse events was not significantly different for albinterferon ( @-@ % ) and pegylated-interferon-@a ( @ % ) .


Total adverse events , however , were higher for albinterferon and correlated to dose .


Decreased lung function was found in all arms ( @ % of patients ) , and was more common in some albinterferon groups .


Albinterferon doses with similar anti-HBV efficacy to pegylated-interferon-@a had higher rates of certain adverse events , particularly changes in lung diffusion capacity ( http://www.clinicaltrials.gov number NCT@ ) .


A randomized controlled trial was carried out to study the effect of a recently proposed technique of ex vivo intra-arterial methylene blue injection of the surgical specimen removed for colorectal cancer on lymph node harvest and staging .


Between May @ and February @ , @ consecutive colorectal cancer resection specimens in a single institution were randomly assigned to intervention ( methylene blue injection ) and control ( standard manual palpation technique ) groups before formalin fixation .


The specimen was then examined by the histopathologist for lymph nodes .


Both groups were similar for age , sex , site of tumour , operation and tumour stage .


In the intervention group , a higher number of nodes was found -LSB- median @ ( @-@ ) vs. @ ( @-@ ) , P < @ -RSB- , with only one specimen not achieving the recommended minimum standard of @ nodes -LSB- @/@ ( @ % ) vs. @/@ ( @ % ) , P = @ -RSB- .


However , there was no upstaging effect in the intervention group -LSB- @/@ ( @ % ) vs. @/@ ( @ % ) ; P = @ -RSB- .


With a significantly lower number of nodes harvested in rectal cancer , the positive effect of the intervention was particularly observed in the patients who underwent preoperative neoadjuvant radiotherapy -LSB- median @ nodes ( @-@ ) vs. @ ( @-@ ) ; P = @ ; proportion of cases with < @ nodes @/@ vs. @/@ ( @ % ) , P = @ -RSB- .


Ex vivo intra-arterial methylene blue injection increases lymph node yield and can help to reduce the number of cases with a lower-than-recommended number of nodes , particularly in patients with rectal cancer having neoadjuvant treatment .


The technique is easy to perform , cheap and saves time .


Spinal anesthesia was considered as a reasonable anesthetic option in severe preeclampsia when cesarean delivery is indicated , and there is no indwelling epidural catheter or contraindication to spinal anesthesia .


However , the ideal dose of intrathecal bupivacaine has not been quantified for cesarean delivery for severe preeclamptic patients .


This study aimed to determine the ED @ and ED @ of intrathecal bupivacaine for severely preeclamptic patients undergoing elective cesarean delivery .


Two hundred severely preeclamptic patients are undergoing elective cesarean delivery under combined spinal-epidural anesthesia enrolled in this randomized , double-blinded , dose-ranging study .


Patients received @ mg , @ mg , @ mg , or @ mg intrathecal hyperbaric bupivacaine with @ g sufentanil .


Successful spinal anesthesia was defined as a T@ sensory level achieved within @ minutes after intrathecal drug administration and/or no epidural supplement was required during the cesarean section .


The ED @ and ED @ were calculated with a logistic regression model .


ED @ and ED @ of intrathecal bupivacaine for successful spinal anesthesia were @ mg ( @ % confidence interval -LSB- CI -RSB- : @-@ @ mg ) and @ mg ( @ % CI : @-@ @ mg ) respectively .


The incidence of hypotension in Group @ mg and Group @ mg was higher than that in Group @ mg and Group @ mg ( P < @ ) .


The sensory block was significantly different among groups @ minutes after intrathecal injection ( P < @ ) .


The use of lidocaine in Group @ mg was higher than that in other groups ( P < @ ) .


The use of phenylephrine in Group @ mg and Group @ mg was higher than that in the other two groups ( P < @ ) .


The lowest systolic blood pressure before the infant delivery of Group @ mg and Group @ mg was lower than the other two groups ( P < @ ) .


The satisfaction of muscle relaxation in Group @ mg was lower than other groups ( P < @ ) .


There was no significant difference in patients ' satisfaction and the newborns ' Apgar score and the blood gas analysis of umbilical artery serum ( P > @ ) .


Our study showed that the ED @ and ED @ of intrathecal bupivacaine for severely preeclamptic patients undergoing elective cesarean delivery were @ mg and @ mg , respectively .


In addition , decreasing the dose of intrathecal bupivacaine could reduce the incidence of maternal hypotension .


We tested the hypothesis that statin use in individuals with COPD is associated with a reduced risk of exacerbations .


We identified @ individuals with COPD and a measurement of C reactive protein ( CRP ) in the Copenhagen General Population Study ( @-@ ) .


During @years of follow-up we recorded exacerbations with hospital admissions or oral corticosteroid treatment .


In a nested case-control design , matching on age , gender , smoking , COPD severity and comorbidity , we estimated the association between statin use and exacerbations .


In addition , we examined the association between statin use and high CRP ( > @mg/L ) , and the association between high CRP and exacerbations during follow-up .


Statin use was associated with reduced odds of exacerbations in crude analysis , OR = @ ( @ % CI @ to @ , p = @ ) , as well as in multivariable conditional logistic regression analysis , OR = @ ( @ to @ , p = @ ) .


However , in the subgroup with the most severe COPD and without cardiovascular comorbidity , we observed a null association between statin use and exacerbations , OR = @ ( @ to @ , p = @ ) .


Furthermore , statin use was associated with reduced odds of a high CRP , OR = @ ( @ to @ , p < @ ) , and a high CRP was associated with an increased risk of exacerbations , HR = @ ( @ to @ , p < @ ) .


We estimated the percentage of excess risk of the association of statin use with exacerbations possibly mediated through a reduction of CRP to be @ % ( @-@ % ) .


Statin use was associated with reduced odds of exacerbations in individuals with COPD from the general population , although this was not apparent in those with the most severe COPD without cardiovascular comorbidity .


Statins may thus only associate with reduced risk of exacerbations in patients with COPD with coexisting cardiovascular disease .


Research on the use of a pressurized metered dose inhaler ( pMDI ) with spacer ( pMDI/spacer ) in children has indicated oral inhalation via the spacer mouthpiece is more efficient than the combination of oral and nasal inhalation that occurs when a pMDI/spacer is used with a facemask .


Changes in pMDI formulations and developments in spacer and facemask designs have highlighted the need for new comparative studies of spacer use , particularly focusing on the age at which children can be taught to transition from use of a pMDI/spacer with facemask to use of the spacer mouthpiece .


Twelve children aged @-@ years ( @ males ) with stable asthma were recruited .


Of these , @ children ( @ males ) completed both arms of the study .


A transmission scan of each compliant subject was taken using a @ MBq ( @m ) Tc flood source .


Actuations ( @-@ ) of a ( @m ) Tc-radiolabeled albuterol pMDI were administered through an antistatic spacer ( OptiChamber Diamond ) via either a facemask ( medium LiteTouch facemask ) , or the spacer mouthpiece .


The subject 's inhalation pattern was simultaneously recorded using a pMDI Datalogger , and narrative data relating to tolerance and compliance were documented .


Anterior and posterior planar scintigraphic scans were taken immediately after aerosol administration .


Mean ( SD ) lung deposition ( % total dose ) was @ ( @ ) % with the facemask and @ ( @ ) % with the spacer mouthpiece ( p > @ ) .


Peripheral lung deposition ( expressed as peripheral : central ( P : C ) ratio ) was higher in @ out of @ children with the facemask compared with the spacer mouthpiece : @ ( @ ) vs. @ ( @ ) ; ( p = @ ) .


Head and neck deposition was higher with use of the facemask compared with the spacer mouthpiece : @ ( @ ) % vs. @ ( @ ) % ( p = @ ) .


Lung deposition achieved using the spacer with facemask was higher than previously reported , with a difference of only @ % of total dose measured compared to the deposition with mouthpiece .


This may be due to a combination of factors including pMDI formulation , and use of an antistatic spacer with a flexible , well-fitting facemask .


There is a shortage of literature describing the experience of individuals who have participated in a physical activity and mobile health ( mHealth ) intervention .


Many physical activity interventions are of short duration and do not report long-term changes in clinical measures or adoption of prescribed health behaviors .


Previously , we have reported the clinical and behavioral outcomes from the first phase of a physical activity prescription and mHealth intervention delivered through the primary care setting .


The purpose of this next phase is to perform a longitudinal follow-up @-months postintervention .


Mixed methods analysis including repeated measures ANOVA of functional aerobic capacity ( VO@max ) at preintervention , postintervention , and follow-up clinic visits , and whole text analysis of semistructured interviews discussing the participant experience in a health behavior intervention .


Twenty participants , mean age @ @ years , participated .


Gains made in VO@max were maintained at @ months ( P < @ ) .


Participants reported engaging in sustained and routine physical activity , yet some identified a need for additional support to adopt the prescribed health behaviors .


Emergent themes included the desire for short-term mHealth intervention to educate individuals about prescribed health behaviors without need for ongoing management by clinicians , leveraging mHealth to build social networks around prescribed health behaviors and to connect individuals to build a sense of community , and participant views of physical activity as medicine .


The present study investigated both the long-term adoption of physical activity behaviors as well as the participant experience in a physical activity and mHealth intervention .


Findings from the current study may be used to inform the development of user-centered lifestyle interventions .


This study was designed to analyze and compare plasma levels of @-isoprostane ( @-epiPGF@ ) , a biomarker of lipid peroxidation , and uric acid ( UA ) , a marker of the antioxidant status , in standard laparoscopic ( LC ) and laparoendoscopic single-site cholecystectomy ( LSSC ) .


Forty patients with noncomplicated cholelithiasis were randomized to undergo either LSSC ( n = @ ) or LC ( n = @ ) .


The patients had body mass index < @ , American Society of Anesthesiologists score I or II , and no previous upper gastrointestinal surgery .


Blood samples were taken preoperatively and @ h and @ h postoperatively .


Levels of @-epiPGF@ were determined using enzyme-linked immunosorbent assay , whereas levels of UA were calculated using automated analyzer .


No significant differences were observed in operative data among the groups .


Levels of @-epiPGF@ were significantly higher in LSSC compared with LC at @ h ( P = @ ) and @ h ( P < @ ) .


@-epiPGF@ levels showed significant changes over time in LC ( LSSC : P = @ , LC : P < @ ) .


UA levels were significantly higher in LC compared with LSSC , @ h postoperatively ( P = @ ) .


No significant changes over time in the UA levels in both groups ( LSSC : P = @ , LC : P = @ ) .


LSSC is associated with increased oxidative stress compared with LC .


Further studies are needed to confirm these results .


To compare intravitreal bevacizumab versus ranibizumab as adjuvant treatment prior to pars plana vitrectomy ( PPV ) in proliferative diabetic retinopathy ( PDR ) with respect to parameters of surgical complexity .


Prospective , randomized , double-masked pilot study of patients requiring PPV for nonclearing vitreous hemorrhage or tractional retinal detachment ( TRD ) secondary to PDR .


Patients were randomized to receive either intravitreal bevacizumab or ranibizumab at standard doses @ week preoperatively .


Measured parameters included total surgical time , presence of TRD , intraoperative bleeding , iatrogenic retinal breaks , and use of endolaser and endodiathermy or silicone oil .


A total of @ patients were recruited .


For surgical parameters , there were no statistically significant differences between the groups in the univariate analyses .


Multivariable analysis showed no statistically significant difference for total surgical time .


This pilot study suggests that intravitreal bevacizumab and ranibizumab are equivalent as surgical adjuvants when used as pre-treatment in patients with PDR undergoing PPV .


Infants with acute lymphoblastic leukemia ( ALL ) present with aggressive disease and a poor prognosis .


Early relapse within @-@ months of diagnosis is common .


Approximately @ % of infants have MLL-rearranged ( MLL-R ) ALL with event free survival ( EFS ) ranging from @ % to @ % .


Children 's Oncology Group ( COG ) P@ used shortened ( @ weeks ) , intensified therapy to address early relapse and poor EFS .


P@ therapy was modified three times for induction toxicity resulting in three cohorts of therapy .


One hundred forty-seven infants were enrolled in the third cohort .


We report an overall @-year EFS and OS of @ % and @ % respectively .


Poor prognostic factors included age @ days at diagnosis , MLL-R ALL and white cell count @,@ / l. For infants @ days of age , the @-year EFS was @ % and @ % for those > @ days ( P < @ ) .


Among infants > @ days of age , @-year EFS rates were @ % for MLL-R versus @ % for MLL-germline ALL ( P < @ ) .


Age @ days at diagnosis was the most important prognostic factor .


Despite shortened therapy with early intensification , EFS remained less than @ % overall in MLL-R ALL .


To compare a computer-assisted home exercise program with conservative home-training following printed instructions in the rehabilitation of elderly patients with vestibular dysfunction .


Single-blind , randomized , controlled trial .


Geriatric department of a university hospital .


Patients with chronic dizziness due to vestibular dysfunction ( N = @ ) were randomly assigned to either rehabilitation in the clinic followed by computer-assisted home exercises ( intervention group : n = @ ) or rehabilitation in the clinic followed by home exercises according to printed instructions ( control group : n = @ ) .


Patients in the intervention group received assisted rehabilitation by a computer program .


Measurements at baseline and at @ and @ weeks were compared .


These included the One Leg Stand Test , Dynamic Gait Index , Chair Stand Test , Motion Sensitivity Test , Short Form-@ , Dizziness Handicap Inventory , and visual analog scale .


Both groups improved significantly during @ weeks of rehabilitation .


However , neither t tests nor repeated-measures analysis of variance demonstrated any significant differences between the @ groups .


The overall compliance rate to computer program exercises during @ weeks was @ % .


A computer-assisted program to support the home training of elderly patients with vestibular dysfunction did not improve rehabilitation more than did printed instructions .


Atrial fibrillation ( AF ) ablation can result in oesophageal injuries that lead to atrio-oesophageal fistulae , a life-threatening complication .


This study aimed to evaluate whether oesophageal cooling could prevent oesophageal lesions complicating AF ablation .


We randomly assigned @ patients with drug-resistant AF to an oesophageal cooling group or a control group .


In the oesophageal cooling group , we injected @ mL of ice water into the oesophagus prior to radiofrequency ( RF ) energy delivery adjacent to the oesophagus .


If the oesophageal temperature reached @C , the RF energy delivery was stopped , and the ice water injection was repeated .


In the control group , oesophageal cooling was not applied .


Oesophageal endoscopy was performed @ day after the catheter ablation , and lesions were qualitatively assessed as mild , moderate , or severe .


The numbers of ablation sites with an oesophageal temperature of > @C were @ @ and @ @ in the oesophageal cooling group and the control group , respectively ( P = @ ) , and the maximal oesophageal temperature at those sites was @ @ and @ @ C ( P < @ ) .


Oesophageal lesions occurred almost equally between the oesophageal cooling group -LSB- @ of @ patients ( @ % ) -RSB- and the control group -LSB- @ of @ patients ( @ % ) -RSB- .


However , the severity of the oesophageal lesions was slightly milder in the oesophageal cooling group ( three moderate , seven mild ) than in the control group ( three severe , one moderate , seven mild ) .


Oesophageal cooling may alleviate the severity of oesophageal lesions but does not reduce the incidence of this complication under the specific protocol evaluated here .


Like other acute and chronic infections , Brucella infection leads to endothelial dysfunction .


Furthermore , it has been suggested that the chronic inflammatory state present in chronic infectious diseases leads to an acceleration in atherosclerosis .


For the prediction of CAD , it is possible to use epicardial fat thickness ( EFT ) as an adjunctive marker beside the classical risk factors , as it is easily and non-invasively evaluated by transthoracic echocardiography .


The purpose of this study was to investigate the presence of impaired myocardial performance as well as of increased arterial stiffness and EFT in patients who had been infected with brucellosis in the past .


Included in the study were twenty-seven brucellosis patients and twenty-six healthy volunteers .


Using EFT and transthoracic echocardiography , which included Doppler echocardiography in combination with tissue Doppler imaging ( TDI ) , all the patients were examined to measure their aortic stiffness index ( AoSI ) , aortic distensibility ( AoD ) , and aortic elastic modulus ( AoEM ) values .


A statistically significant increase was observed in hs-CRP , aortic stiffness index , aortic elastic modulus and EFT in brucellosis patients when compared with the controls ( @ + / - @ vs. @ ?


@ , P = @ ; @ + / - @ vs. @ + / - @ , P < @ ; @ + / - @ vs @ + / - @ , P < @ ; @ + / - @ vs. @ + / - @ , P < @ ) .


On the other hand , there was a significant decrease in aortic strain and aortic distensibility ( @ ?


@ vs @ + / - @ , P < @ ; @ + / - @ vs. @ + / - @ , P < @ , respectively ) .


No difference was observed between the two groups with respect to the left ventricular myocardial performance index ( MPI ) ( @ + / - @ vs. @ + / - @ , P = @ ) .


In this study , we demonstrated for the first time in the literature thatthere was impaired aortic elasticity and increased EFT in patients with brucellosis , while the myocardial performance index remained unaffected .


We also determined that these effects had a significant correlation with inflammation .


Breast cancer survivors experience long-term physical and psychological sequelae after their primary treatment that negatively influence their quality of life ( QOL ) and increase depressive symptoms .


Group-based cognitive-behavioral stress management ( CBSM ) delivered after surgery for early-stage breast cancer was previously associated with better QOL over a @-month follow-up and with fewer depressive symptoms up to @ years after study enrollment .


This @ - to @-year follow-up ( median , @ years ) of a previously conducted trial ( NCT@ ) evaluated whether women in this cohort receiving CBSM had fewer depressive symptoms and better QOL than controls at an @ - to @-year follow-up .


Women with stage @ to IIIb breast cancer were initially recruited @ to @ weeks after surgery and randomized to a @-week CBSM intervention or a @-day psychoeducational control group .


One hundred women ( @ CBSM patients and @ controls ) were recontacted @ to @ years after study enrollment to participate in a follow-up assessment .


The Center for Epidemiologic Studies-Depression ( CES-D ) scale and the Functional Assessment of Cancer Therapy-Breast ( FACT-B ) were self-administered .


Multiple regression was employed to evaluate group differences on the CES-D scale and FACT-B over and above effects of confounding variables .


Participants assigned to CBSM reported significantly lower depressive symptoms ( d , @ ; @ % confidence interval -LSB- CI -RSB- , @-@ @ ) and better QOL ( d , @ ; @ % CI , @-@ @ ) above the effects of the covariates .


Women who received CBSM after surgery for early-stage breast cancer reported lower depressive symptoms and better QOL than the control group up to @ years later .


Early implementation of cognitive-behavioral interventions may influence long-term psychosocial functioning in breast cancer survivors .


Relatively few studies have examined the long-term outcome of psychotherapy in social anxiety disorder .


The authors previously reported findings of a clinical trial comparing cognitive-behavioral therapy ( CBT ) , psychodynamic therapy , and a wait-list control .


The purpose of the present study was to follow the participants ' status over the ensuing @ months .


Outpatients with social anxiety disorder who were treated with CBT ( N = @ ) or psychodynamic therapy ( N = @ ) in the previous trial were assessed @ , @ , and @ months after the end of therapy .


Primary outcome measures were rates of remission and response .


For both CBT and psychodynamic therapy , response rates were approximately @ % by the @-year follow-up .


Remission rates were nearly @ % for both treatment conditions .


Rates of response and remission were stable or tended to increase for both treatments over the @-month follow-up period , and no significant differences were found between the treatment conditions after @ months .


CBT and psychodynamic therapy were efficacious in treating social anxiety disorder , in both the short - and long-term , when patients showed continuous improvement .


Although in the short-term , intention-to-treat analyses yielded some statistically significant but small differences in favor of CBT in several outcome measures , no differences in outcome were found in the long-term .


Youth in high-poverty neighborhoods have high rates of emotional problems .


Understanding neighborhood influences on mental health is crucial for designing neighborhood-level interventions .


To perform an exploratory analysis of associations between housing mobility interventions for children in high-poverty neighborhoods and subsequent mental disorders during adolescence .


The Moving to Opportunity Demonstration from @ to @ randomized @ volunteer public housing families with @ children in high-poverty neighborhoods into @ of @ housing mobility intervention groups ( a low-poverty voucher group vs a traditional voucher group ) or a control group .


The low-poverty voucher group ( n = @ ) received vouchers to move to low-poverty neighborhoods with enhanced mobility counseling .


The traditional voucher group ( n = @ ) received geographically unrestricted vouchers .


Controls ( n = @ ) received no intervention .


Follow-up evaluation was performed @ to @ years later ( June @-April @ ) with participants aged @ to @ years ( @-@ years at randomization ) .


Response rates were @ % to @ % .


Presence of mental disorders from the Diagnostic and Statistical Manual of Mental Disorders ( Fourth Edition ) within the past @ months , including major depressive disorder , panic disorder , posttraumatic stress disorder ( PTSD ) , oppositional-defiant disorder , intermittent explosive disorder , and conduct disorder , as assessed post hoc with a validated diagnostic interview .


Of the @ adolescents randomized , @ were interviewed ( @ boys and @ girls ) .


Compared with the control group , boys in the low-poverty voucher group had significantly increased rates of major depression ( @ % vs @ % ; odds ratio ( OR ) , @ -LSB- @ % CI , @-@ @ -RSB- ) , PTSD ( @ % vs @ % ; OR , @ -LSB- @ % CI , @-@ @ -RSB- ) , and conduct disorder ( @ % vs @ % ; OR , @ -LSB- @ % CI , @-@ @ -RSB- ) .


Boys in the traditional voucher group had increased rates of PTSD compared with the control group ( @ % vs @ % , OR , @ -LSB- @ % CI , @-@ @ -RSB- ) .


However , compared with the control group , girls in the traditional voucher group had decreased rates of major depression ( @ % vs @ % ; OR , @ -LSB- @ % CI , @-@ @ -RSB- ) and conduct disorder ( @ % vs @ % ; OR , @ -LSB- @ % CI , @-@ @ -RSB- ) .


Interventions to encourage moving out of high-poverty neighborhoods were associated with increased rates of depression , PTSD , and conduct disorder among boys and reduced rates of depression and conduct disorder among girls .


Better understanding of interactions among individual , family , and neighborhood risk factors is needed to guide future public housing policy changes .


Observational studies suggest that minimal gestational weight gain ( GWG ) may optimize pregnancy outcomes for obese women .


This trial tested the efficacy of a group-based weight management intervention for limiting GWG among obese women .


One hundred and fourteen obese women ( BMI -LSB- meanSD -RSB- @ kg/m ( @ ) ) were randomized between @ and @ weeks ' ( @ ) gestation to intervention ( n = @ ) or usual care control conditions ( n = @ ) .


The intervention included individualized calorie goals , advice to maintain weight within @ % of randomization and follow the Dietary Approaches to Stop Hypertension dietary pattern without sodium restriction , and attendance at weekly group meetings until delivery .


Control participants received one-time dietary advice .


Our three main outcomes were maternal weight change from randomization to @ weeks postpartum and from randomization to @ weeks gestation , and newborn large-for-gestational age ( birth weight > @th percentile , LGA ) .


Intervention participants gained less weight from randomization to @ weeks gestation ( @ vs. @ kg , mean difference = -@ kg , @ % CI -LSB- -@ -@ -RSB- ) , and from randomization to @ weeks postpartum ( -@ vs. +@ kg , mean difference = -@ kg , @ % CI -LSB- -@ -@ -RSB- ) .


They also had a lower proportion of LGA babies ( @ vs. @ % , odds ratio = @ , @ % CI -LSB- @-@ @ -RSB- ) .


The intervention resulted in lower GWG and lower prevalence of LGA newborns .


To examine whether transcutaneous electric nerve stimulation at acupoints ( Acu-TENS ) improved the biochemical and physical indices of patients with type @ diabetes mellitus ( T@DM ) .


Ninety subjects with T@DM were divided randomly into a control group ( n = @ ) , aerobic exercise group ( n = @ ) , or Acu-TENS group ( n = @ ) .


In addition to conventional diabetes drug treatment , patients in the Acu-TENS group received acupoint stimulation , the aerobic exercise group engaged in walking exercises , and the control group was given sham electrical stimulation .


All groups were treated for @ min for each session and five times a week for @ months .


The indices of glycosylated hemoglobin , @ h postprandial glucose , fasting serum insulin , triglyceride , total cholesterol , and body mass index were assessed at pre-treatment , post-treatment , and follow-up , which was @ months after treatment .


The indices of the control group were not changed ( P > @ ) at the three time points .


At the pre-treatment measurement , there were significant differences ( P > @ ) in indices among the three groups .


At post-treatment , each index of the two groups was lower than that of the control group ( P < @ ) , and improved in comparison with the pre-treatment measurement ( P < @ ) .


In follow-up , each index of the aerobic exercise group and Acu-TENS group increased , but was still decreased compared with the pre-treatment value ( P < @ ) , excluding body mass index .


Acu-TENS could improve the state of patients with T@DM and be used as a therapy in clinical application .


To describe the subjective experience of patients and surgeons during laser in situ keratomileusis ( LASIK ) using the Intralase @ kHz or the Visumax @ kHz femtosecond laser .


Singapore National Eye Centre , Singapore .


Prospective randomized clinical study .


In myopic patients , LASIK was performed with the corneal flap created using the @ kHz laser in @ eye and the @ kHz laser in the contralateral eye .


Postoperatively , patients completed a standardized validated questionnaire about their subjective intraoperative experiences ( eg , light perception , pain , fear ) .


Surgeons reported their intraoperative experiences and preferences .


Loss of light perception occurred in @ % of @ kHz laser cases and @ % of @ kHz laser cases during docking and in @ % and @ % of cases , respectively , during laser flap creation ( P < @ ) .


The mean pain score with the @ kHz laser was significantly higher during docking ( P < @ ) but not during laser flap cutting ( P = @ ) .


Subconjunctival hemorrhage occurred in @ % of eyes with the @ kHz laser and in @ % of eyes with the @ kHz laser ( P < @ ) .


The @ kHz laser was preferred by @ % of patients , while @ % preferred the @ kHz laser ( P < @ ) .


The surgeons preferred the @ kHz laser in @ % of cases and the @ kHz laser in @ % ( P < @ ) ; @ % had no preference .


Patients preferred surgery with the @ kHz laser with no loss of light perception , less pain , less fear , and less subconjunctival hemorrhage .


Surgeons preferred the @ kHz laser .


Peak internal knee abduction moment is a common surrogate variable associated with medial compartment knee loading .


Stair descent has been shown to yield a greater peak knee abduction moment compared to level-walking .


Changes in step width ( SW ) may lead to changes in frontal plane lower extremity limb alignment in the frontal plane and alter peak knee abduction moment .


The purpose of this study was to investigate the effects of increased SW on frontal plane knee biomechanics during stair descent in healthy older adults .


Twenty healthy adults were recruited for the study .


A motion analysis system was used to obtain three-dimensional lower limb kinematics during testing .


An instrumented @-step staircase with two additional customized wooden steps was used to collect ground reaction forces ( GRF ) data during stair descent trials .


Participants performed five stair descent trials at their self-selected speed using preferred , wide ( @ % leg length ) , and wider ( @ % leg length ) SW .


The preferred normalized SW in older adults during stair descent was @ % of leg length .


Wide and wider SW during stair descent reduced both first and second peak knee adduction angles and abduction moments compared to preferred SW in healthy adults .


Increased SW reduced peak knee adduction angles and abduction moments .


The reductions in knee abduction moments may have implications in reducing medial compartment knee loads during stair descent .


To evaluate the prognostic importance of transient or persistent elevations of cardiac troponin-I ( cTnI ) and N-terminal-B-type natriuretic peptide ( NT-proBNP ) in atrial fibrillation ( AF ) .


Plasma samples were obtained at randomisation and after @ months in @ patients with AF in the RE-LY trial ; median follow-up was @ years .


Patients were grouped based on levels at the two time points according to detectable cTnI levels ( @ g/L ) or NT-proBNP levels above median ( @ ng/L ) .


These groups were related to occurrence of stroke or cardiovascular events evaluated with Cox models adjusting for established risk factors .


The proportion of patients with detectable cTnI levels at both time points was @ % , at one time point @ % and at neither time point @ % .


Patients with detectable cTnI at both time points had substantially higher rates of stroke compared with those with transient elevations and those with no elevation at either time point ( p < @ , effect of cTnI ) .


Persistent elevation of either or both cardiac biomarkers at baseline and @ months was associated with a higher risk for cardiovascular events and mortality ( p < @ ) .


Prognostic prediction improved most with the use of repeated measurements of both cardiac biomarkers simultaneously ( p < @ ) and achieved C-statistic @ for stroke compared with @ for CHADS@-score .


Persistent elevation of troponin and NT-proBNP indicates a worse prognosis than transient elevations or no elevations of either marker .


Prognostication of stroke , death and thromboembolic events is improved by the use of repeated determinations of cardiac biomarkers .


Although reperfusion injury has been shown to be responsible for cardiomyocytes death after an acute myocardial infarction , there is currently no drug on the market that reduces this type of injury .


TRO@ is a new cardioprotective compound that was shown to inhibit the opening of the mitochondrial permeability transition pore and reduce infarct size after ischemia-reperfusion in a rat model of cardiac ischemia-reperfusion injury .


In the rat model , the therapeutic window and the dose effect relationship were investigated in order to select the proper dose and design for clinical investigations .


To evaluate post-ischemic functional recovery , TRO@ was tested in a model of isolated rat heart .


Additionally , TRO@ was investigated in a Phase I randomized , double-blind , placebo controlled study to assess the safety , tolerability and pharmacokinetics of single intravenous ascending doses of the compound ( @ to @ mg/kg ) in @ healthy male , post-menopausal and hysterectomized female subjects at flow rates from @ to @ mL/min ( EudraCT number : @-@-@ ) .


This work was supported in part by the French Agence Nationale de la Recherche .


In the vivo model , TRO@ reduced infarct size by @ % at @ mg/kg and by @ % at @ and @ mg/kg given by intravenous bolus and was only active when administered before reperfusion .


Additionally , TRO@ provided functional recovery and reduced oxidative stress in the isolated rat heart model.These results , together with pharmacokinetic based allometry to human and non-clinical toxicology data , were used to design the Phase I trial .


All the tested doses and flow rates were well tolerated clinically .


There were no serious adverse events reported .


No relevant changes in vital signs , electrocardiogram parameters , laboratory tests or physical examinations were observed at any time in any dose group .


Pharmacokinetics was linear up to @ mg/kg and slightly ~ @-fold , hyper-proportional from @ to @ mg/kg .


These data demonstrated that TRO@ can be safely administered by the intravenous route in humans at doses expected to be pharmacologically active .


These results allowed evaluating the expected active dose in human at @ mg/kg , used in a Phase II proof-of-concept study currently ongoing .


Age-related muscle loss ( that is , sarcopenia ) is a common health problem among older people .


Physical exercise and dietary protein have been emphasized in prevention and treatment of sarcopenia .


Rigorous trials investigating the effects of protein supplementation on physical performance in sarcopenic populations are still scarce .


The aim of this study is to investigate the effects of protein supplementation along with simple home-based exercises on physical performance among home-dwelling sarcopenic older people .


During @ the entire @ and older population ( N = @,@ ) living in Porvoo , Finland was contacted via a postal questionnaire .


Persons at risk of sarcopenia are screened with hand grip strength and gait speed .


Poorly performing persons are further examined by segmental bioimpendance spectroscopy to determine their skeletal muscle index .


Sarcopenic patients ( target N = @ ) will be enrolled in a @-month randomized controlled trial with three arms : @ ) no supplementation , @ ) protein supplementation ( @ grams twice a day ) , and @ ) isocaloric placebo .


All the participants will receive instructions on simple home-based exercises , dietary protein , and vitamin D supplementation ( @ g/d ) .


The recruitment of patients will be completed during @ .


The primary endpoint of the trial is the change in short physical performance battery score and percentage of patients maintaining or improving their physical performance .


Secondary endpoints will be , among other things , changes in muscle functions , nutritional status , body composition , cognition , quality of life , use of health care services , falls , and mortality .


The assessment times will be @ , @ , @ and @ months .


To our knowledge , this is the first large scale randomized controlled trial among community dwelling older people with sarcopenia that focuses on the effects of protein supplementation on physical performance .


AST-@ ( spherical carbon adsorbent ) was previously reported to be effective for perianal fistula healing in Japanese patients with mild-to-moderate Crohn 's disease .


To evaluate the efficacy and safety of AST-@ in a Western population , a phase @ , multicenter , randomized , double-blind , placebo-controlled , study ( FHAST-@ ) was conducted in adult patients with at least @ draining perianal fistula and a Crohn 's disease activity index < @ .


Patients received either AST-@ or matching placebo at a dose of @ g @ times daily for @ weeks .


The primary endpoint was the proportion of patients with treatment success , defined as a @ % reduction in the number of draining fistulae , at both weeks @ and @ .


A multivariate model was generated to assess covariates for treatment success among baseline variables .


Two hundred forty-nine patients were randomized ( AST-@ ; n = @ ; placebo , n = @ ) .


The proportions of patients achieving the primary endpoint were no different between treatment groups ( @ % versus @ % , P = @ ) .


No differences in fistula response were noted at week @ ( @ % versus @ % , P = @ ) or week @ ( @ versus @ % , P = @ ) .


Serum C-reactive protein concentrations > @ mg/dL and Crohn 's disease activity index scores > @ at baseline were associated with a reduced likelihood of treatment success ( odds ratio , @ ; confidence interval , @-@ @ ; P = @ ; and odds ratio , @ ; confidence interval , @-@ @ ; P = @ , respectively ) .


In this largest placebo-controlled trial to date to evaluate the impact of a therapeutic agent on perianal fistulae in Crohn 's disease , the efficacy of AST-@ could not be confirmed .


An inverse relationship was observed between both inflammatory and clinical disease activity and fistula response .


To examine the effects of communication skills training on physiotherapists ' supportive behavior during clinical practice .


Randomized trial .


Hospital outpatient physiotherapy clinics .


Physiotherapists ( N = @ ) and patients ( N = @ ) with chronic low back pain .


Two hospital clinics were randomly assigned to the intervention arm .


Physiotherapists ( n = @ ) received @ hours of communication skills training focused on supporting patients ' psychological needs .


Physiotherapists ( n = @ ) from @ other hospital clinics formed a waitlist control arm .


Verbal communication between each physiotherapist and a patient was recorded on an audiotape , and independent , blinded raters used the Health Care Climate Questionnaire to assess physiotherapists ' needs-supportive behavior ( primary outcome ) .


Independent raters ' Health Care Climate Questionnaire scores favored the intervention arm ( Cohen 's d = @ ; P < @ ) .


Compared with controls , independent ratings demonstrated that physiotherapists who completed the Communication style and exercise compliance in physiotherapy training were found to provide greater support for patients ' needs in a single assessed session .


Long-term maintenance of this needs-supportive behavior should be examined .


Very little is known about the relationship between non-sickle cell anemia and stroke .


The purpose of this study is to evaluate the association of iron-deficiency anemia ( IDA ) with stroke based on a nationwide coverage database in Taiwan .


The case-control study subjects were obtained from the Taiwanese Longitudinal Health Insurance Database @ .


We included @,@ subjects with stroke as cases and randomly selected @,@ controls ( @ controls per case ) in this study.Separate conditional logistic regression analyses were used to calculate the odds ratio ( OR ) for having been previously diagnosed with IDA between cases and controls.We further analyzed the association between stroke and IDA by stroke subtype .


Results showed that @,@ study subjects ( @ % ) had been diagnosed with IDA prior to the index date ; of those subjects , @,@ ( @ % ) were cases and @,@ ( @ % ) were controls ( p < @ ) .


Conditional logistic regression shows that the OR of having previously received an IDA diagnosis among cases was @ ( @ % CI : @ ~ @ ; p < @ ) that of controls after adjusting for monthly income , geographic region , hypertension , diabetes , coronary heart disease , atrial fibrillation , heart failure , hyperlipidemia , tobacco use disorder , and alcohol abuse/alcohol dependency syndrome .


Furthermore , the adjusted OR of prior IDA for cases with ischemic stroke was found to be @ ( @ % CI : @ ~ @ ) compared to controls .


However , we did not find any significant relationship between IDA and subarachnoid/intracerebral hemorrhage even adjusting for other confounding factors ( OR = @ , @ % CI = @ ~ @ ) .


There is a significant association between prior IDA and ischemic stroke .


Fatigue is one of the most common and debilitating symptoms of multiple sclerosis ( MS ) .


The aim was to evaluate the effectiveness at @-year follow-up of a manualised group-based programme ( ` FACETS ' ) for managing MS-fatigue .


One-year follow-up of a pragmatic multi-centre randomised controlled trial .


People with MS and significant fatigue were randomised to FACETS plus current local practice ( FACETS ) or current local practice alone ( CLP ) , using concealed computer-generated randomisation .


Participant blinding was not possible .


Primary outcome measures were fatigue severity ( Global Fatigue Severity subscale of the Fatigue Assessment Instrument ) , self-efficacy ( MS-Fatigue Self-Efficacy ) and disease-specific quality of life ( MS Impact Scale ) .


Between May @ and November @ , @ participants were randomised .


Primary outcome data were available at @year for @ ( @ % ) .


The benefits demonstrated at @-months in the FACETS arm for fatigue severity and self-efficacy largely persisted , with a slight reduction in standardised effect sizes ( SES ) ( -@ , p = @ and @ , p = @ , respectively ) .


There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at @-months ( SES -@ , p = @ ) .


No adverse events were reported .


Improvements in fatigue severity and self-efficacy at @-months follow-up following attendance of FACETS were mostly sustained at @year with additional improvements in MS impact .


The FACETS programme provides modest long-term benefits to people with MS-fatigue .


To determine whether regional hyperthermia ( RHT ) in addition to chemotherapy improves local tumor control after macroscopically complete resection of abdominal or retroperitoneal high-risk sarcomas .


Within the prospectively randomized EORTC @ phase-III trial , RHT and systemic chemotherapy significantly improved local progression-free survival ( LPFS ) and disease-free survival ( DFS ) in patients with abdominal and extremity sarcomas .


That trial included macroscopically complete and R@ resections .


A subgroup analysis of the EORTC trial was performed and long-term survival determined .


From @ patients , @ ( median age @ years , @-@ ) were identified with macroscopic complete resection ( R@ , R@ ) of abdominal and retroperitoneal soft-tissue sarcomas ( median diameter @ cm , G@ @ % , G@ @ % ) .


Seventy-six patients were treated with EIA ( etoposide , ifosfamide , doxorubicin ) + RHT ( @ cycles : @ % ) versus @ patients receiving EIA alone ( @ cycles : @ % , P = @ ) .


LPFS and DFS as well as overall survival were determined .


RHT and systemic chemotherapy significantly improved LPFS ( @ % vs @ % after @ years , P = @ ) and DFS ( @ % vs @ % after @ years , P = @ ) .


Overall survival was not significantly improved in the RHT group ( @ % vs @ % after @ years , P = @ ) .


Perioperative morbidity and mortality were not significantly different between groups .


In patients with macroscopically complete tumor resection , RHT in addition to chemotherapy resulted in significantly improved local tumor control and DFS without increasing surgical complications .


Within a multimodal therapeutic concept for abdominal and retroperitoneal high-risk sarcomas , RHT is a treatment option beside radical surgery and should be further evaluated in future trials .


To explore the therapeutic effect of acupuncture for hypertensive cerebral hemorrhage at the early stage .


Fifty-four cases of small-amount cerebral hemorrhage were randomized into an acupuncture group and a conventional treatment group , @ cases in each one .


In the conventional treatment group , special care , oxygen therapy , nerve nutrition and symptomatic support were applied .


In necessary , dehydrant and hypotensive drugs were prescribed for antihypertension , or surgery was given .


In the acupuncture group , on the basis of the treatment as the control group , acupuncture was applied at Quchi ( LI @ ) , Neiguan ( PC @ ) , Zusanli ( ST @ ) , Sanyinjiao ( SP @ ) and Taichong ( LR @ ) .


Acupuncture was given at the admission , @ h , @ h and @ h after disease onset respectively .


Blood pressure was monitored in the whole procedure .


@ h and @ h after disease onset , the cranial CT was re-examined .


Systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , hematoma volume and neurological deficit score were compared at different time points between the two groups .


( @ ) Blood pressure : from the admission to @ h after disease onset , SBP , DBP and MAP were increased apparently in the conventional treatment group and increased slightly in the acupuncture group .


The differences in SBP -LSB- ( @ + / - @ ) mmHg vs ( @ + / - @ ) mmHg -RSB- and MAP -LSB- ( @ + / - @ ) mmHg vs ( @ + / - @ ) mmHg -RSB- were significant between the two groups ( both P < @ ) .


From @ h to @ h after disease onset , compared with the conventional treatment group , SBP and MAP were decreased apparently in the acupuncture group -LSB- ( @ + / - @ ) mmHg vs ( @ + / - @ ) mmHg , ( @ + / - @ ) mmHg vs ( @ + / - @ ) mmHg , both P < @ ) -RSB- .


( @ ) Hematoma volume : from the admission to @ h after disease onset , the volume was increased by ( @ + / - @ ) mL in the convertional treatment group and ( @ + / - @ ) mL in the acupuncture group , indicating the significant difference in comparison ( P < @ ) .


From the admission to @ h after disease onset , it was increased by ( @ + / - @ ) mL in the convertional treatment group and ( @ + / - @ ) mL in the acupuncture group , indicating the significant difference in comparison ( P < @ ) .


( @ ) Neurological deficit score : the score was increasing gradually in first @ days after disease onset in the two groups .


The score ( @ + / - @ ) in the acupuncture group on the first day was different significantly as compared with that ( @ + / - @ ) in the conventional treatment group ( P < @ ) .


On the @th days , the score ( @ + / - @ ) in the acupuncture group was different significantly from that ( @ + / - @ ) in the convertional treatment group ( P < @ ) .


There is no peak of blood pressure rising , and the continuous hemorrhagic volume is less in @ h and neurological deficit score is improved in the acupuncture group .


Acupuncture brings the positive significance in the treatment of cerebral hemorrhage at the early stage .


We compared stepwise addition of bolus insulin with a full basal-bolus regimen in patients with type @ diabetes inadequately controlled on basal insulin plus oral antidiabetic drugs .


The FullSTEP study was a phase @ , @-week , randomised , open-label , two-arm , parallel-group , multinational , treat-to-target , non-inferiority trial done at @ sites across seven countries to assess the effectiveness of a stepwise dosing approach versus a basal-bolus regimen .


In this trial , @ patients ( mean age @ years -LSB- SD @ -RSB- ; HbA@c @ % -LSB- @ mmol/mol -RSB- ; mean diabetes duration @ years -LSB- SD @ -RSB- ) were block randomised ( ratio @:@ ) to receive either stepwise treatment or full basal-bolus treatment .


Patients in the basal-bolus group received insulin aspart before every meal throughout the trial .


Patients in the stepwise group received one bolus dose with the largest meal , with additional insulin aspart doses before the next largest meal added to their regimen at @ weeks and @ weeks if HbA@c remained at @ % or higher .


The primary outcome was non-inferiority of stepwise addition of bolus insulin versus complete basal-bolus therapy , as assessed by change in HbA@c from baseline to @ weeks ( non-inferiority margin of @ % ) .


This trial is registered with ClinicalTrials.gov , number NCT@ .


The study was started on Oct @ , @ , and completed on April @ , @ .


After @ weeks , HbA@c change from baseline was -@ % ( @ % CI -@ to -@ ) for the stepwise group and -@ % ( -@ to -@ ) for the basal-bolus group ; mean treatment difference @ ( @ % CI -@ to @ ) , non-significant ( p = @ ) .


Fewer hypoglycaemic episodes occurred in the stepwise group than in the basal-bolus group ( rate ratio @ -LSB- @ % CI @ to @ -RSB- ; p < @ ) .


Treatment-emergent adverse events did not differ between the two treatment groups .


The most frequently reported treatment-emergent adverse event were nasopharyngitis , influenza , diarrhoea , headache , peripheral oedema , and wrong drug given .


Three participants died : two before randomisation and one in the basal-bolus group ( due to severe acute myocardial infarction and respiratory tract inflammation ) .


Stepwise prandial insulin intensification provides glycaemic control non-inferior to a full basal-bolus regimen after @ weeks , with significantly lower hypoglycaemia risk and better patient satisfaction .


RP is a reversible vasoconstriction of digital arteries that causes pain and skin discoloration .


This study compared the efficacy of the new phosphodiesterase type @ inhibitor udenafil with that of the calcium channel blocker amlodipine in the treatment of secondary RP .


A total of @ patients with secondary RP associated with connective tissue diseases were enrolled in this double-blind , randomized , cross-over study .


The patients were randomized to receive udenafil @ mg/day or amlodipine @ mg/day for @ weeks .


After a washout period they were crossed over to the other drug for another @ weeks .


The primary outcome was RP frequency before and after treatment .


The secondary outcomes were RP condition scores , RP duration , number of digital ulcers , HAQ , physician global assessment and digital artery flow before and after treatment .


Amlodipine and udenafil both decreased the rate of RP attack significantly .


The drugs did not differ in terms of RP frequency or any of the secondary outcomes except for digital blood flow ; udenafil improved it significantly better than amlodipine ( P = @ ) .


Udenafil was well tolerated without serious adverse effects .


Udenafil and amlodipine have comparable efficacy in improving RP attacks .


In addition , udenafil improves the blood flow in digital arteries compared with amlodipine .


This study aimed at comparing the development of tricuspid and mitral regurgitation between the right ventricular outflow tract ( RVOT ) and right ventricular apex ( RVA ) pacing .


We prospectively enrolled @ patients for permanent pacemaker implantation due to sick sinus syndrome or atrioventricular block and randomly divided them into two equal groups to receive either RVOT or RVA pacing .


Patients with heart failure or valvular disease were excluded .


The post-procedural echocardiographic evaluations were performed @year after the pre-procedural echocardiography , and the results were compared with respect to the development of mitral and tricuspid regurgitation and probable changes in the ejection fraction ( EF ) .


Age , gender , pacing mode , and baseline cardiac rhythm did not significantly differ between the RVOT and RVA pacing groups .


The incidence of mitral regurgitation was significantly higher in the RVA group ( p = @ ) , but the incidence of tricuspid regurgitation was similar in both groups .


There was a trend toward less tricuspid regurgitation in the RVOT group ; however , it was not statistically significant .


The mean EF was not significantly different between the study groups .


It seems that the incidence of mitral regurgitation in RVA pacing is significantly higher than that in RVOT pacing .


The formation of tricuspid regurgitation needs to be discussed in the future .


To investigate the impact of using paclitaxel-coated balloons ( PCB ) on outcome after post-angioplasty dissection in femoropopliteal arteries .


The angiograms obtained in the THUNDER study ( ClinicalTrials.gov identifier NCT@ ) were analyzed to compare degrees of dissection and angiographic parameters between the control ( uncoated balloons , n = @ ) and treatment ( PCBs , n = @ ) groups before and after the intervention and at @-month follow-up .


Furthermore , target lesion revascularizations ( TLR ) were documented up to @ years .


In each group , @ ( @ % ) patients had a dissection after the intervention .


At the @-month follow-up , patients with dissection of any grade after treatment with PCBs had significantly less late lumen loss ( @ mm ) than patients with dissection after treatment with uncoated balloons ( @ mm , p = @ ) and a lower degree of stenosis ( @ % vs. @ % , respectively ; p = @ ) .


Patients with severe dissection ( grades C , D , or E ) especially seemed to benefit from the PCBs , with late lumen loss of @ mm vs. @ mm for controls ( p = @ ) .


The binary restenosis rate was also markedly lower in the PCB group ( @ % ) than in the uncoated group ( @ % , p = @ ) .


In the @-year follow-up , TLR was performed in @ % of patients in the control group compared to @ % of patients in the PCB group ( p = @ ) .


The results of this subgroup analysis suggest that patients with dissection following treatment with a paclitaxel-coated balloon have a very acceptable outcome and stent implantation is not necessary as long as the dissection does not result in acute flow limitation .


To examine whether mindfulness-based cognitive therapy ( MBCT ) would enhance attenuated amplitudes of event-related potentials ( ERPs ) indexing performance monitoring biomarkers of attention-deficit/hyperactivity disorder ( ADHD ) .


Fifty adult ADHD patients took part in a randomised controlled study investigating ERP and clinical measures pre-to-post MBCT .


Twenty-six patients were randomly allocated to MBCT , @ to a wait-list control .


Main outcome measures included error processing ( ERN , Pe ) , conflict monitoring ( NoGo-N@ ) , and inhibitory control ( NoGo-P@ ) ERPs concomitant to a continuous performance task ( CPT-X ) .


Inattention and hyperactivity-impulsivity ADHD symptoms , psychological distress and social functioning , and mindfulness skills were also assessed .


MBCT was associated with increased Pe and NoGo-P@ amplitudes , coinciding with reduced ` hyperactivity/impulsivity ' and ` inattention ' symptomatology .


Specific to the MBCT ; enhanced Pe amplitudes correlated with a decrease in hyperactivity/impulsivity symptoms and increased ` act-with-awareness ' mindfulness skill , whereas , enhanced P@ correlated with amelioration in inattention symptoms .


MBCT enhanced ERP amplitudes associated with motivational saliency and error awareness , leading to improved inhibitory regulation .


MBCT suggests having comparable modulation on performance monitoring ERP amplitudes as pharmacological treatments .


Further study and development of MBCT as a treatment for ADHD is warranted , in addition to its potential scope for clinical applicability to broader defined externalising disorders and clinical problems associated with impairments of the prefrontal cortex .


To investigate the long-term effect of bosentan on outcome in patients after Fontan operation .


Patients after Fontan surgery were randomly divided into bosentan group ( B , n = @ ) and control group ( C , n = @ ) .


Bosentan was applied within @ days after Fontan surgery as follows : at the first month , @ mg Bid for patients with body weight @ kg ; @ mg Bid for patients with body weight between @-@ kg ; @ mg Bid for patients with body weight @-@ kg and @ mg Bid for patients with body weight > @ kg .


At the second month , the bosentan dose was doubled and Bosentan therapy was continued for more than @ year .


Group C did n't take drugs affecting pulmonary artery pressure .


All patients were followed up for @ years and incidence of mortality , protein losing enteropathy , pulmonary arteriovenous fistulae , @-minute walk test , heart function were compared between the two groups .


After @ years , mortality tended to be lower in group B compared to group C -LSB- @ % ( @/@ ) vs. @ % ( @/@ ) , P > @ -RSB- .


Incidence of pulmonary arteriovenous fistulae and protein losing enteropathy were significantly lower in group B than in group C ( @ % vs. @ % , P = @ ; @ % vs. @ % , P = @ , respectively ) .


The results of @-minute walk test -LSB- ( @ @ ) m vs. ( @ @ ) m -RSB- and heart function in group B ( @ NYHA III/IV patients in group B vs. @ NYHA III/IV patients in group C , all P < @ ) were all better than group C.


The concentrations of vasoactive factors such as brain natriuretic peptide ( BNP , @ @ vs. @ @ ) , endothelin ( ET , @ @ vs. @ @ ) and thromboxane ( TXA@ , @ @ vs. @ @ ) were also significantly lower in group B than in group C ( all P < @ ) .


Prostacyclin ( PGI@ ) level and incidence of arrhythmias were similar between the two groups .


There was no thrombotic event in both groups during follow up .


Bosentan trerapy in patients post Fontan operation could reduce the incidence of pulmonary arteriovenous fistulae and protein losing enteropathy and improve heart function .


In schizophrenia , the presence of certain cognitive biases has been established .


Informed by this , metacognitive training ( MCT ) has been developed for schizophrenia .


There is increasing evidence of its effectiveness with some patients , but its applicability to dangerous patients has not yet been demonstrated .


Our aim was to test the feasibility of a randomised controlled trial ( RCT ) of MCT for patients in a high-security hospital setting .


Twenty of @ eligible and selected male in-patients with schizophrenia and a history of violence were randomised pairwise to eight sessions of MCT or treatment as usual .


Symptom severity and reasoning , according to the jumping to conclusions paradigm , were measured before , immediately after treatment , and @ and @months later .


Men in both groups completed the trial , and those in the MCT arm , almost all of the group sessions .


The MCT arm had a significant advantage in improvement of ` suspiciousness ' , greatest at @months , but then declining .


No significant improvement in reasoning ability was achieved .


Metacognitive training showed sufficient promise in this group for a full trial to be worthwhile , and the feasibility of an RCT methodology , even in a secure hospital , was established .


The fact that the improvements faded during follow-up suggests that a useful modification to the treatment would be lengthening the protocol , repeating it , or both .


We evaluated week-on/week-off axitinib dosing plus chemotherapy in patients with gastrointestinal tumours , including tumour thymidine uptake by fluorine-@ @ ' - deoxy-@ ' - fluorothymidine positron emission tomography ( ( @ ) FLT-PET ) .


During a lead-in period , patients received twice daily ( b.i.d. ) axitinib @ mg ( n = @ ) or @ mg ( n = @ ) for @ days followed by a @-day dosing interruption ; serial ( @ ) FLT-PET scans were performed before day @ and on days @ , @ , and @ .


Axitinib plus FOLFIRI or FOLFOX was then administered in @-week cycles ; axitinib was interrupted on day @ of each cycle for @ days .


The maximum tolerated dose of axitinib was @ mg b.i.d. , in a week-on/week-off schedule , combined with FOLFIRI or FOLFOX .


Common all-causality grade @ adverse events were neutropenia ( @ % ) , hypertension ( @ % ) , and fatigue ( @ % ) .


Of @ patients , @ ( @ % ) had a partial response and @ ( @ % ) had stable disease .


Following @ days of continuous axitinib dosing , tumour ( @ ) FLT uptake decreased -@ % from baseline and recovered to -@ % and -@ % from baseline , respectively , after @ and @ days of axitinib interruption .


Axitinib administered in a week-on/week-off schedule combined with FOLFIRI or FOLFOX is supported by ( @ ) FLT-PET data and was well tolerated in patients with gastrointestinal tumours .


Classification schemas for low back pain ( LBP ) , such as the Treatment-Based Classification and the Movement System Impairment , use common clinical features to subgroup patients with LBP and are purported to improve treatment outcomes .


To assess if providing matched treatments based on patient-specific clinical features led to superior treatment outcomes compared with an unmatched treatment for subjects with chronic recurrent LBP .


This study is a randomized controlled trial .


Subjects ( n = @ ) with LBP ( @ months ) with or without recurrences underwent a standardized clinical examination to group them into one of two strata : ineligible or eligible for stabilization exercises based on the Treatment-Based Classification schema .


Subjects underwent additional clinical tests to assign them to one of the five possible Movement System Impairment categories .


Questionnaires were collected electronically at Week @ ( before treatment ) , Week @ ( after the @-week @-hour treatment sessions ) , and @ months .


Using the Oswestry disability index ( @-@ ) and the Numeric Pain Rating Scale ( @-@ ) , the primary analysis was performed using the intention-to-treat principle .


Secondary outcomes included fear-avoidance beliefs and psychosocial work-related and general health status .


After subjects were categorized based on their particular clinical features using both the Treatment-Based Classification and Movement System Impairment schemas , they were randomized into one of two treatments using a @:@ ratio for matched or unmatched treatments .


The treatments were trunk stabilization exercise or Movement System Impairment-directed exercises .


Of the patients allocated to treatment for this study , @ received a matched treatment and @ received an unmatched treatment .


After treatment , both groups showed a statistically significant improvement in the primary outcome measures and almost all the secondary measures ; however , the matched treatment group did not demonstrate superior outcomes at Week @ or @ months , except on one of the secondary measures ( Graded Chronic Pain Scale -LSB- Disability Scale -RSB- ) ( p = @ ) .


Providing a matched treatment based on either the Treatment-Based Classification or the Movement System Impairment classification schema did not improve treatment outcomes compared with an unmatched treatment for patients with chronic LBP , except on one secondary disability measure .


Wound infiltration at the end of carotid endarterectomy under general anaesthesia is a simple technique that can be delegated to the surgeon .


It was hypothesised that this technique could improve early post-operative analgesia by reducing the need for post-operative opioids .


Forty patients underwent carotid endarterectomy under general anaesthesia with desflurane and remifentanil supplemented with morphine for post-operative analgesia .


In a prospective double-blinded randomised study , patients were allocated pre-operatively to receive either subcutaneous infiltration of both wound edges with @ ml of @ % ropivacaine or infiltration with isotonic saline .


The primary outcome was morphine consumption while in the post-anaesthesia care unit ( PACU ) .


Pain scores at rest and movement , sedation , and patient satisfaction were the other main outcomes used to assess post-operative analgesia .


The median dose of morphine administered in the PACU was @ mg -LSB- @-@ -RSB- in the ropivacaine vs. @ mg -LSB- @-@ -RSB- in the placebo group ( P = @ , Mann-Whitney 's test ) .


Pain at rest and at movement was lower in the ropivacaine group throughout observation in the PACU .


No difference was found for both pain and opioid consumption after discharge from the PACU or for patient satisfaction .


Sedative events in the early post-operative period were less frequent in the ropivacaine group .


Local anaesthetic wound infiltration performed before closure reduces the need for additional opioids , lowers the immediate post-operative pain and improves alertness .


These results argue for the use of local infiltration anaesthesia for carotid endarterectomy .


Venous thromboembolism is common in patients with cancer and requires anticoagulation with low molecular weight heparin .


Current data informs anticoagulation as far as six months , yet guidelines recommend anticoagulation beyond six months in patients who have locally advanced or metastatic cancer .


This recommendation , based on expert consensus , has not been evaluated in a clinical study .


ALICAT ( Anticoagulation Length in Cancer Associated Thrombosis ) is a feasibility study to identify the most clinically and cost effective length of anticoagulation with low molecular weight heparin in the treatment of cancer associated thrombosis .


ALICAT is a randomized multi-centre phase two mixed-methods study with three components : a randomized controlled trial , embedded qualitative study and a survey investigating pathways of care .


The randomized controlled trial will compare ongoing low molecular weight heparin treatment for cancer-associated thrombosis versus cessation of low molecular weight heparin at six months treatment ( current licensed practice ) in patients with locally advanced or metastatic cancer .


The embedded qualitative study will include focus groups with clinicians to investigate attitudes to recruiting to the study , identify the challenges of progressing to a full randomized controlled trial , and also semi-structured interviews with patients and relatives/carers to explore their attitudes towards participating in the study and potential barriers and concerns to participation .


Finally , a UK wide survey exercise will be undertaken to develop a classification and enumeration system for the cancer associated thrombosis models and pathways of care .


There is a lack of evidence determining the length of anticoagulation for patients with cancer associated thrombosis and subsequently treatment length varies .


The ALICAT study will consider the feasibility of recruiting patients to a phase three trial .


For women with hormone receptor-positive , operable breast cancer , surgical oophorectomy plus tamoxifen is an effective adjuvant therapy .


We conducted a phase III randomized clinical trial to test the hypothesis that oophorectomy surgery performed during the luteal phase of the menstrual cycle was associated with better outcomes .


Seven hundred forty premenopausal women entered a clinical trial in which those women estimated not to be in the luteal phase of their menstrual cycle for the next one to six days ( n = @ ) were randomly assigned to receive treatment with surgical oophorectomy either delayed to be during a five-day window in the history-estimated midluteal phase of the menstrual cycles , or in the next one to six days .


Women who were estimated to be in the luteal phase of the menstrual cycle for the next one to six days ( n = @ ) were excluded from random assignment and received immediate surgical treatments .


All patients began tamoxifen within @ days of surgery and continued this for @ years .


Kaplan-Meier methods , the log-rank test , and multivariable Cox regression models were used to assess differences in five-year disease-free survival ( DFS ) between the groups .


All statistical tests were two-sided .


The randomized midluteal phase surgery group had a five-year DFS of @ % , compared with @ % for the immediate surgery random assignment group ( hazard ratio -LSB- HR -RSB- = @ , @ % confidence interval -LSB- CI -RSB- = @ to @ , P = @ ) .


Multivariable Cox regression models , which included important prognostic variables , gave similar results ( aHR = @ , @ % CI = @ to @ , P = @ ) .


For overall survival , the univariate hazard ratio was @ ( @ % CI = @ to @ , P = @ ) and the multivariable aHR was @ ( @ % CI = @ to @ , P = @ ) .


Better DFS for follicular phase surgery , which was unanticipated , proved consistent across multiple exploratory analyses .


The hypothesized benefit of adjuvant luteal phase oophorectomy was not shown in this large trial .


The goal of this study was to investigate the differential efficacy of clopidogrel or aspirin monotherapy according to smoking status in patients with atherosclerotic vascular disease .


Smoking enhances clopidogrel-induced platelet inhibition , which may explain the higher relative benefit among smokers observed in trials evaluating dual antiplatelet therapy .


Whether smoking has an impact on clinical outcomes in patients requiring a single antiplatelet agent remains unknown .


This was a post-hoc analysis of the CAPRIE ( Clopidogrel Versus Aspirin in Patients at Risk of Ischemic Events ) trial that compared clopidogrel and aspirin monotherapy in patients ( N = @,@ ) with atherosclerotic vascular disease .


Current smokers ( n = @,@ ) had an increased risk of ischemic events compared with never smokers ( n = @,@ ; hazard ratio -LSB- HR -RSB- : @ -LSB- @ % confidence interval ( CI ) : @ to @ -RSB- ) and ex-smokers ( n = @,@ ; HR : @ -LSB- @ % CI : @ to @ -RSB- ) ( p < @ ) .


Clopidogrel was associated with a reduction in ischemic events among current smokers ( @ % vs. @ % ; HR : @ -LSB- @ % CI : @ to @ -RSB- ) , whereas no benefit over aspirin was seen in the combined group of ex-smokers/never-smoked patients ( @ % vs. @ % ; HR : @ -LSB- @ % CI : @ to @ -RSB- ; p = @ for interaction ) .


Among current smokers , clopidogrel also reduced myocardial infarction , vascular death , and death from any cause compared with aspirin .


No interaction between smoking status and study treatment was observed for bleeding events .


In a post-hoc analysis of the CAPRIE population , current smokers appeared to have enhanced benefit with clopidogrel therapy for secondary prevention compared with aspirin .


These results should be considered hypothesis generating for future prospective studies assessing the impact of specific platelet-inhibiting strategies according to smoking status .


To evaluate the efficacy of faculty-led problem-based learning ( PBL ) vs online simulated-patient case in fourth-year ( P@ ) pharmacy students .


Fourth-year pharmacy students were randomly assigned to participate in either online branched-case learning using a virtual simulation platform or a small-group discussion .


Preexperience and postexperience student assessments and a survey instrument were completed .


While there were no significant differences in the preexperience test scores between the groups , there was a significant increase in scores in both the virtual-patient group and the PBL group between the preexperience and postexperience tests .


The PBL group had higher postexperience test scores ( @ ) than did the virtual-patient group ( @ ) ( p = @ ) .


The PBL method demonstrated significantly greater improvement in postexperience test scores than did the virtual-patient method .


Both were successful learning methods , suggesting that a diverse approach to simulated patient cases may reach more student learning styles .


Hamilton depression rating scale ( HAMD ) subscales provide an economic alternative for the full scale ; however , their ability to detect onset of improvement in the early course of treatment ( EI ) has not yet been researched .


The present study investigated in patients with major depression ( MD ) whether the subscales are a comparable option to predict treatment remission in the early course of treatment .


Based on data from @ MD patients of a @-week randomised , placebo-controlled trial comparing mirtazapine ( MIR ) and paroxetine ( PAR ) , the discriminative and predictive validity of EI for ( stable ) remission at treatment end was evaluated for seven subscales and the HAMD@ in the total and in treatment subgroups ( MIR vs. PAR ) .


Receiver operating characteristics ( ROC ) curves ( at week @ ) and the Clinical Global Impression scales ( CGI ) ( at study endpoint ) were used to validate the @ % EI criterion for the subscales .


Only the Evans@ and Toronto@ subscale had almost the same predictive value as the HAMD@ ( e.g. , sensitivities stable remission Evans@/Toronto@ : @/@ % vs. @ % HAMD@ ) .


The optimal cut-off for EI to predict remission was just below @ % for most subscales and slightly over @ % for stable remission .


Study sample representativeness , non-independence of subscales , missing external validation criterion , lack of control group .


The Evans@ and Toronto@ subscales are valuable alternatives in situations , where economic aspects play a larger role .


A sum score reduction of @ % as definition for EI seems also appropriate for the HAMD subscales , in the total as well as in the antidepressant subgroups .


To evaluate the effectiveness and safety of a T-piece resuscitator compared with a self-inflating bag for providing mask ventilation to newborns at birth .


Newborns at @ weeks gestational age receiving positive-pressure ventilation at birth were included in this multicenter cluster-randomized @-period crossover trial .


Positive-pressure ventilation was provided with either a self-inflating bag ( self-inflating bag group ) with or without a positive end-expiratory pressure valve or a T-piece with a positive end-expiratory pressure valve ( T-piece group ) .


Delivery room management followed American Academy of Pediatrics and International Liaison Committee on Resuscitation guidelines .


The primary outcome was the proportion of newborns with heart rate ( HR ) @ bpm at @ minutes after birth .


A total of @ newborns were included .


There was no statistically significant difference in the incidence of HR@ bpm at @ minutes after birth between the T-piece and self-inflating bag groups : @ % ( @ of @ ) and @ % ( @ of @ ) , respectively ( OR , @ ; @ % CI , @-@ @ ; P = @ ) .


A total of @ newborns ( @ % ) in the T-piece group and @ newborns ( @ % ) in the self-inflating bag group were intubated in the delivery room ( OR , @ ; @ % CI , @-@ @ ; P = @ ) .


The meanSD maximum positive inspiratory pressure was @ cm H@O in the T-piece group vs @ cm H@O in the self-inflating bag group ( P < @ ) .


Air leaks , use of drugs/chest compressions , mortality , and days on mechanical ventilation did not differ significantly between groups .


There was no difference between the T-piece resuscitator and a self-inflating bag in achieving an HR of @ bpm at @ minutes in newborns@ weeks gestational age resuscitated at birth .


However , use of the T-piece decreased the intubation rate and the maximum pressures applied .


To compare operative time with use of THUNDERBEAT ( TB ) vs standard electrosurgery ( SES ) during laparoscopic radical hysterectomy and pelvic lymphadenectomy to treat gynecologic tumors .


Evidence obtained from a properly designed , randomized , controlled trial ( Canadian Task Force classification I ) .


Gynecologic Oncology Unit of the Catholic University of the Sacred Heart in Rome , Italy .


Fifty patients with early cervical cancer ( FIGO stages IA@ , IB@ , IIA < @ cm ) or locally advanced cervical cancer ( FIGO stages IB@ , IIA > @cm , IIB ) who received neoadjuvant treatment ( chemotherapy or radiochemotherapy ) and demonstrated a complete or partial clinical response and early stage endometrioid endometrial cancer ( FIGO stages IB , II ) were randomly assigned to undergo TB ( arm A ) or SES ( arm B ) .


Laparoscopic radical hysterectomy with bilateral pelvic lymphadenectomy , using an easily reproducible technique was performed .


Fifty patients were available for analysis , with @ women randomly assigned to TB ( arm A ) and @ to SES ( arm B ) .


The median operative time was @ minutes for TB vs @ minutes for SES ( p = @ ) .


At multivariate analysis , endometrial cancer ( p = @ ) and TB ( p = @ ) were independently associated with shorter operating time .


No differences in perioperative outcomes and postoperative complications were observed between the @ arms .


Patients who underwent TB reported less postoperative pain , both at rest ( p = @ ) and after the Valsalva maneuver ( p = @ ) , with less additional analgesic therapy other than standard therapy required in patients who underwent SES ( p = @ ) .


TB is associated with shorter operative time and less postoperative pain than is the standard technique ( SES ) in patients with uterine cancer .


To evaluate the long-term efficacy of pain reduction by two dose-fractionation schedules for radiotherapy of painful shoulder syndrome .


Between February @ and February @ , @evaluable patients were recruited for this prospective trial .


All patients received low-dose orthovoltage radiotherapy .


One course consisted of @fractions in @weeks .


In the case of insufficient pain remission after @weeks , a second course was administered .


Patients were randomly assigned to one of two groups to receive single doses of either @ or @ Gy .


Endpoint was pain reduction .


Pain was measured before radiotherapy , as well as immediately after ( early response ) , @weeks after ( delayed response ) and approximately @years after ( long-term response ) completion of radiotherapy using a questionnaire-based visual analogue scale ( VAS ) and a comprehensive pain score ( CPS ) .


Median follow-up was @months ( range@-@ ) .


The overall early , delayed and long-term response rates for all patients were @ , @ and @ % , respectively .


The mean VAS scores before treatment and those for early , delayed and long-term response in the @ - and @-Gy groups were @ and @ ( p = @ ) ; @ and @ ( p = @ ) ; @ and @ ( p = @ ) and @ and @ ( p = @ ) , respectively .


The mean CPS values before treatment and those for early , delayed and long-term response were @ and @ ( p = @ ) ; @ and @ ( p = @ ) ; @ and @ ( p = @ ) and @ and @ ( p = @ ) , respectively .


No significant differences in the quality of the long-term response were found between the @ - and @-Gy arms ( p = @ ) .


Radiotherapy is an effective treatment for the management of benign painful shoulder syndrome .


For radiation protection reasons , the dose for a radiotherapy series should not exceed @ Gy .


Management of recent-onset schizophrenia ( SZ ) and schizoaffective disorder ( SA ) is challenging owing to frequent insufficient response to antipsychotic agents .


This study aimed to test the efficacy and safety of the neurosteroid pregnenolone in patients with recent-onset SZ/SA .


Sixty out - and inpatients who met DSM-IV criteria for SZ/SA , with suboptimal response to antipsychotics were recruited for an @-week , double-blind , randomized , placebo-controlled , two-center add-on trial , that was conducted between @ and @ .


Participants were randomized to receive either pregnenolone ( @mg/day ) or placebo added on to antipsychotic medications .


The primary outcome measures were the Positive and Negative Symptoms Scale and the Assessment of Negative Symptoms scores .


Secondary outcomes included assessments of functioning , and side-effects .


Analysis was by linear mixed model .


Fifty-two participants ( @ % ) completed the trial .


Compared to placebo , adjunctive pregnenolone significantly reduced Positive and Negative Symptoms Scale negative symptom scores with moderate effect sizes ( d = @ ) .


Significant improvement was observed in weeks @ and @ of pregnenolone therapy among patients who were not treated with concomitant mood stabilizers ( armsvisitmood stabilizers ; P = @ ) .


Likewise , pregnenolone significantly reduced Assessment of Negative Symptoms scores compared to placebo ( d = @ ) , especially on blunted affect , avolition and anhedonia domain scores .


Other symptoms , functioning , and side-effects were not significantly affected by adjunctive pregnenolone .


Antipsychotic agents , benzodiazepines and sex did not associate with pregnenolone augmentation .


Pregnenolone was well tolerated .


Thus , add-on pregnenolone reduces the severity of negative symptoms in recent-onset schizophrenia and schizoaffective disorder , especially among patients who are not treated with concomitant mood stabilizers .


Further studies are warranted .


Loneliness in older people is associated with poor health-related quality of life ( HRQoL ) .


We undertook a parallel-group randomised controlled trial to evaluate the effectiveness and cost-effectiveness of telephone befriending for the maintenance of HRQoL in older people .


An internal pilot tested the feasibility of the trial and intervention .


Participants aged > @years , with good cognitive function , living independently in one UK city were recruited through general practices and other sources , then randomised to : ( @ ) @weeks of short one-to-one telephone calls , followed by @weeks of group telephone calls with up to six participants , led by a trained volunteer facilitator ; or ( @ ) a control group .


The main trial required the recruitment of @ participants in a @-year accrual window , of whom @ were to receive telephone befriending .


The pilot specified three success criteria which had to be met in order to progress the main trial to completion : recruitment of @ participants in @days ; retention of @ % participants at @months ; successful delivery of telephone befriending by local franchise of national charity .


The primary clinical outcome was the Short Form ( @ ) Health Instrument ( SF-@ ) Mental Health ( MH ) dimension score collected by telephone @months following randomisation .


We informed @,@ older people about the study .


Seventy consenting participants were randomised to the pilot in @days , with @ ( @ % ) providing valid primary outcome data ( @ intervention , @ control ) .


Twenty-four participants randomly allocated to the research arm actually received telephone befriending due to poor recruitment and retention of volunteer facilitators .


The trial was closed early as a result .


The mean @-month SF-@ MH scores were @ ( SD @ ) and @ ( SD @ ) for the intervention and control groups , respectively ( mean difference , @ ; @ % CI , -@ to @ ) .


Recruitment and retention of participants to a definitive trial with a recruitment window of @year is feasible .


For the voluntary sector to recruit sufficient volunteers to match demand for telephone befriending created by trial recruitment would require the study to be run in more than one major population centre , and/or involve dedicated management of volunteers .


To evaluate the effectiveness of an educational intervention to decrease pediatric emergency department ( PED ) visits and adverse care practices for upper respiratory infections ( URI ) among predominantly Latino Early Head Start ( EHS ) families .


Four EHS sites in New York City were randomized .


Families at intervention sites received @ @-hour education modules in their EHS parent-child group focusing on URIs , over-the-counter medications , and medication management .


Standard curriculum families received the standard EHS curriculum , which did not include URI education .


During weekly telephone calls for @ months , families reported URI in family members , care sought , and medications given .


Pre - and post-intervention knowledge-attitude surveys were also conducted .


Outcomes were compared between groups .