We followed patients for one year after the web-based or in-person follow-up evaluation and documented any resource use related to the joint arthroplasty .


We conducted cost analyses from the health-care payer ( Ontario Ministry of Health and Long-Term Care ) and societal perspectives .


All costs are presented in 2012 Canadian dollars .


A total of 229 patients ( 118 in the web-based group , 111 in the usual-care group ) completed the study .


The mean cost of the assessment from the societal perspective was $ 98 per patient for the web-based assessment and $ 162 per patient for the usual method of in-person follow-up .


The cost for the web-based assessment was significantly lower from the societal perspective ( mean difference , $ -64 ; 95 % confidence interval [ CI ] , $ -79 to $ -48 ; p < 0.01 ) and also from the health-care payer perspective ( mean difference , $ -27 ; 95 % CI , $ -29 to $ -25 ; p < 0.01 ) .


The web-based follow-up assessment had a lower cost per patient compared with in-person follow-up from both societal and health-care payer perspectives .


Despite aggressive local therapy , patients with locally advanced bladder cancer have a significant risk of distant metastases .


This study evaluated the role of neoadjuvant combination chemotherapy with gemcitabine/cisplatin ( GC ) in improving the outcome of this group of patients over radical cystectomy alone .


A total of 114 patients with newly diagnosed bladder cancer ( T3-4 , N0-2 , M0 ) were randomized to radical cystectomy alone or initial 3 cycles of GC , then managed according to response .


Patients who achieved complete response completed 6 cycles of GC followed by local radiation therapy ( RT ) only .


If tumors were downstaged to T1 , complete transurethral resection was done , followed by 3 cycles of GC and then RT. .


Patients with partial response underwent radical cystectomy followed by 3 cycles of GC .


Patients with stable disease or disease progression underwent radical cystectomy .


The overall response rate to GC was 55.1 % , and complete response was achieved in 28.6 % .


The 3-year overall survival ( OS ) was 51.9 % versus 51.2 % in the chemotherapy and surgery arms , respectively ( P = .399 ) .


The 3-year disease-free survival was 31.8 % in the chemotherapy arm and 45.1 % in the surgery arm ( P = .06 ) .


Bladder preservation was achieved in 22.5 % of patients in the neoadjuvant arm .


OS was 78 % in responding patients and 100 % in patients with complete response .


Neoadjuvant GC did not improve survival in locally advanced bladder cancer over radical cystectomy alone .


However , bladder preservation was feasible , and OS in responding patients was impressive .


Therefore , predictive models to select patients are needed .


This is the largest prospective study of squamous cell carcinoma and transitional cell carcinoma using neoadjuvant GC .


Fragile X syndrome ( FXS ) is an inherited neurodevelopmental condition characterised by behavioural , learning disabilities , physical and neurological symptoms .


In addition , an important degree of comorbidity with autism is also present .


Considered a rare disorder affecting both genders , it first becomes apparent during childhood with displays of language delay and behavioural symptoms.Main aim : To show whether the combination of 10 mg/kg/day of ascorbic acid ( vitamin C ) and 10 mg/kg/day of - tocopherol ( vitamin E ) reduces FXS symptoms among male patients ages 6 to 18 years compared to placebo treatment , as measured on the standardized rating scales at baseline , and after 12 and 24 weeks of treatment.Secondary aims : To assess the safety of the treatment .


To describe behavioural and cognitive changes revealed by the Developmental Behaviour Checklist Short Form ( DBC-P24 ) and the Wechsler Intelligence Scale for Children-Revised .


To describe metabolic changes revealed by blood analysis .


To measure treatment impact at home and in an academic environment .


A phase II randomized , double-blind pilot clinical trial .


male children and adolescents diagnosed with FXS , in accordance with a standardized molecular biology test , who met all the inclusion criteria and none of the exclusion criteria .


clinical data , blood analysis , Wechsler Intelligence Scale for Children-Revised , Conners parent and teacher rating scale scores and the DBC-P24 results will be obtained at the baseline ( t0 ) .


Follow up examinations will take place at 12 weeks ( t1 ) and 24 weeks ( t2 ) of treatment .


A limited number of clinical trials have been carried out on children with FXS , but more are necessary as current treatment possibilities are insufficient and often provoke side effects .


In the present study , we sought to overcome possible methodological problems by conducting a phase II pilot study in order to calculate the relevant statistical parameters and determine the safety of the proposed treatment .


The results will provide evidence to improve hyperactivity control and reduce behavioural and learning problems using ascorbic acid ( vitamin C ) and - tocopherol ( vitamin E ) .


The study protocol was approved by the Regional Government Committee for Clinical Trials in Andalusia and the Spanish agency for drugs and health products .


ClinicalTrials.gov Identifier : NCT01329770 ( 29 March 2011 ) .


To investigate the effect of regular aerobic training and postexercise protein-carbohydrate supplementation in patients with facioscapulohumeral muscular dystrophy ( FSHD ) .


In this randomized , double-blind , placebo-controlled parallel study , we randomized untrained men ( n = 21 ) and women ( n = 20 ) with FSHD ( age 19-65 years ) to 2 training groups-training with protein supplement ( n = 18 ) and training with placebo supplement ( n = 13 ) - and a nonintervention control group ( n = 10 ) .


We assessed fitness , walking speed , muscle strength , questionnaires , and daily activity levels before and after 12 weeks of interventions .


Training involved 36 sessions of 30-minute cycle-ergometer training .


After each session , patients drank either a protein-carbohydrate or placebo beverage .


In the trained participants , fitness , workload , and walking speed improved ( 10 % [ confidence interval ( CI ) 4 % -15 % ] , 18 % [ CI 10 % -26 % ] , 7 % [ CI 4 % -11 % ] , respectively , p < 0.001 , number needed to treat = 2.1 ) .


Self-assessed physical capacity and health ( Short Form-36 ) also improved .


Muscle strength and daily activity levels did not change with training .


Protein-carbohydrate supplementation did not result in further improvements in any tests compared to training alone .


This randomized , controlled study showed that regular endurance training improves fitness , walking speed , and self-assessed health in patients with FSHD without causing muscle damage .


Postexercise protein-carbohydrate supplementation does not add any further improvement to training effects alone .


This study provides Class II evidence that regular aerobic training with or without postexercise protein-carbohydrate supplementation improves fitness and workload in patients with FSHD .


Iodine deficiency in infants can damage the developing brain and increase mortality .


Present recommendations state that oral iodised oil should be given to breastfeeding mothers to correct iodine deficiency in infancy when iodised salt is not available , and that direct supplementation should be given to infants who are not being breastfed or receiving iodine-fortified complimentary foods .


However , there is little evidence for these recommendations .


We aimed to assess the safety and efficacy of direct versus indirect supplementation of the infant .


We did this double blind , randomised , placebo-controlled trial in Morocco .


Healthy breastfeeding mothers and their term newborn babies ( aged 8 weeks ) were block randomised by clinic day to receive either : one dose of 400 mg iodine to the mother and placebo to the infant ( indirect infant supplementation ) , or one dose of about 100 mg iodine to the infant and placebo to the mother ( direct infant supplementation ) .


Randomisation was masked to participants and investigators .


Coprimary outcomes were : maternal and infant urinary iodine concentrations , breastmilk iodine concentration , maternal and infant thyroid-stimulating hormone ( TSH ) concentrations , maternal and infant thyroxine ( T4 ) concentrations , and infant growth .


These outcomes were measured at baseline , and when infants were aged about 3 months , 6 months , and 9 months , and the two groups were compared using mixed effects models .


This study is registered with ClinicalTrials.gov , number NCT01126125 .


We recruited 241 mother-infant pairs between Feb 25 , and Aug 10 , 2010 , and completed data collection by Aug 6 , 2011 .


At baseline , median urinary iodine concentration was 35 g/L ( IQR 29-40 ) in mothers and 73 g/L ( 29-237 ) in infants , suggesting iodine deficiency .


During the study , maternal urinary iodine concentration ( p = 0.011 ) , breastmilk iodine concentration ( p < 0.0001 ) , and infant urinary iodine concentration ( p = 0.042 ) were higher in the indirect infant supplementation group than in the direct supplementation group .


Maternal TSH ( p = 0.276 ) and T4 ( p = 0.074 ) concentrations did not differ between the groups over the course of the study , nor did infant TSH ( p = 0.597 ) and T4 ( p = 0.184 ) concentrations , but the number of infants with thyroid hypofunction was lower ( p = 0.023 ) in the indirect supplementation group than the direct supplementation group .


The infant groups did not differ in anthropomorphic measures , except that length-for-age Z score was slightly greater in the direct infant supplementation group ( p = 0.032 ) .


At 3 months and 6 months of age , median infant urinary iodine concentration in the indirect infant supplementation group was sufficient ( > 100 g/L ) , whereas infant urinary iodine concentration was sufficient only at 6 months in the direct supplementation group .


There were no serious adverse events in either group .


In regions of moderate-to-severe iodine deficiency without effective salt iodisation , lactating women who receive one dose of 400 mg iodine as oral iodised oil soon after delivery can provide adequate iodine to their infants through breastmilk for at least 6 months , enabling the infants to achieve euthyroidism .


Direct supplementation is less effective in improving infant iodine status .


ETH Zurich , Switzerland ; the Medicor Foundation , Vaduz , Lichtenstein .


The intention of the PEPCAD China ISR ( A Prospective , Multicenter , Randomized Trial of Paclitaxel-Coated versus Paclitaxel-Eluting Stent for the Treatment of Drug-Eluting Stent In-Stent Restenosis ) was to demonstrate the efficacy of paclitaxel-coated balloon ( PCB ) angioplasty in a non-European patient population with coronary drug-eluting stent in-stent restenosis ( DES-ISR ) .


The treatment of DES-ISR is still challenging with no established best strategy .


Moreover , there is no study on the effect of PCB in the treatment of ISR in the Chinese population .


PEPCAD China ISR was a 220-patient randomized ( 1:1 ) , single-blind prospective multicenter trial conducted in China .


Patients with coronary DES-ISR received either PCB ( SeQuent Please , B. Braun Melsungen AG , Melsungen , Germany ) or paclitaxel-eluting stent ( Taxus Libert , Boston Scientific , Natick , Massachusetts ) treatment .


The primary endpoint was in-segment late lumen loss at 9 months .


There were no significant baseline differences between both treatment groups in terms of patient , lesion , or procedural characteristics .


At 9 months , in-segment late lumen loss in the PCB group was noninferior to that of the paclitaxel-eluting stent group ( 0.46 0.51 mm vs. 0.55 0.61 mm ; difference : -0.06 mm with 95 % confidence interval : -0.23 to 0.10 ; p for noninferiority = 0.0005 ) .


The 9-month rate of binary restenosis and 12-month composite clinical event rates were not significantly different between groups .


In a randomized trial of 220 patients , angioplasty with a PCB was noninferior to paclitaxel-eluting stent implantation when used to treat DES-ISR .


On the basis of these , as well as previous randomized trial data , PCB angioplasty offers an effective treatment for DES-ISR without the necessity of implanting additional metal layers for drug release .


( A Safety and Efficacy Study of Paclitaxel-Eluting Balloon to Paclitaxel-Eluting Stent [ PEPCAD ] ; NCT01622075 ) .


Four-factor prothrombin complex concentrates ( PCCs ) , which contain factorII , FVII , FIX , and FX , have shown the potential to reverse the anticoagulant effect of rivaroxaban in healthy volunteers .


The purpose of this study was to determine whether a three-factor PCC , which contains little FVII , has a similar effect .


We performed an open-label , single-center , parallel-group study comparing the effect of a three-factor PCC ( ProfilnineSD ) with that of a four-factor PCC ( BeriplexP/N ) on the pharmacodynamics of rivaroxaban in 35 healthy volunteers .


After receiving 4days of rivaroxaban 20mg twice daily to obtain supratherapeutic steady-state concentrations , volunteers were randomized to receive a single 50IUkg ( -1 ) bolus dose of four-factor PCC , three-factor PCC or saline 4h after the morning dose of rivaroxaban on day5 , and the effects of these interventions on prothrombin time and thrombin generation were determined .


Within 30min , four-factor PCC reduced mean prothrombin time by 2.5-3 .5 s , whereas three-factor PCC produced only a 0.6-1 .0 - s reduction .


In contrast , three-factor PCC reversed rivaroxaban-induced changes in thrombin generation more than four-factor PCC .


This study demonstrates the potential of both three-factor and four-factor PCCs to at least partially reverse the anticoagulant effects of rivaroxaban in healthy adults .


The discrepant effects of the PCC preparations may reflect differences in the procoagulant components present in each .


Dental care is a significant unmet health care need for children with autism spectrum disorders ( ASD ) .


Many children with ASD do not receive dental care because of fear associated with dental procedures ; oftentimes they require general anesthesia for regular dental procedures , placing them at risk of associated complications .


Many children with ASD have a strong preference for visual stimuli , particularly electronic screen media .


The use of visual teaching materials is a fundamental principle in designing educational programs for children with ASD .


To determine if an innovative strategy using 2 types of electronic screen media was feasible and beneficial in reducing fear and uncooperative behaviors in children with ASD undergoing dental visits .


We conducted a randomized controlled trial at Boston Children 's Hospital dental clinic .


Eighty ( 80 ) children aged 7 to 17 years with a known diagnosis of ASD and history of dental fear were enrolled in the study .


Each child completed 2 preventive dental visits that were scheduled 6 months apart ( visit 1 and visit 2 ) .


After visit 1 , subjects were randomly assigned to 1 of 4 groups : ( 1 ) group A , control ( usual care ) ; ( 2 ) group B , treatment ( video peer modeling that involved watching a DVD recording of a typically developing child undergoing a dental visit ) ; ( 3 ) group C , treatment ( video goggles that involved watching a favorite movie during the dental visit using sunglass-style video eyewear ) ; and ( 4 ) group D , treatment ( video peer modeling plus video goggles ) .


Subjects who refused or were unable to wear the goggles watched the movie using a handheld portable DVD player .


During both visits , the subject 's level of anxiety and behavior were measured using the Venham Anxiety and Behavior Scales .


Analyses of variance and Fisher 's exact tests compared baseline characteristics across groups .


Using intention to treat approach , repeated measures analyses were employed to test whether the outcomes differed significantly : ( 1 ) between visits 1 and 2 within each group and ( 2 ) between each intervention group and the control group over time ( an interaction ) .


Between visits 1 and 2 , mean anxiety and behavior scores decreased significantly by 0.8 points ( P = .03 ) 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 = .06 ) .


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 2 compression rates : 100 per minute ( 100-cpm ) and `` push as-fast-as you-can '' ( PF ) .


The participants performed chest compressions at a rate of either 100-cpm or PF and subsequently switched to the other after a 50-minute rest .


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


During the PF session , the rescuers performed CPR with higher compression rates ( 156.8 vs 101.6 cpm ) , more compressions ( 787.2 vs 510.8 per 5 minutes ) , and more duty cycles ( 51.0 % vs 41.7 % ) , but a lower percentage of effective compressions ( 47.7 % vs 57.9 % ) and a lower compression depth ( 35.6 vs 38.0 mm ) than they did during the 100-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 100-cpm session .


The percentile of compressions with adequate depth in the 100-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 100-cpm technique during the 5-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 ( > 18 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 300 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 12 months , with 85.5 % ( n = 1289 ) 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 2 g/dl at 12 weeks after randomization .


Gastric cancer patients after oncologic resection and postoperative hemoglobin level7 g/dl to < 10 g/dl at postoperative days 5 to 7 will be eligible for trial inclusion .


After randomization , 450 patients ( 225 per group ) are going to be subjected either to administration of ferric carboxymaltose ( treatment group ) or normal ( 0.9 % ) saline ( placebo group ) .


Patients will be blinded to the intervention .


Patients will undergo evaluation for hemoglobin level , hematology and quality of life assessment 3 and 12 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 .


NCT01725789 ( international : http://www.clinicaltrials.gov ) and NCCCTS-12-644 ( NCC , Korea ) .


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 130 mg of dehydroepiandrosterone ( DHEA ) or placebo ( n = 8 subjects each ) for 5 days and also provided untreated fasting blood samples ( n = 12 subjects ) for cell culture experiments .


AR mRNA content and TNF release were measured before and after DHEA administration in the fasting state and 2 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 ( 175 ng/dL ) or T ( 50 ng/dL ) , the absolute change in TNF release increased after exposure to T concentrations of 125 and 250 ng/dL and a DHEA concentration of 1750 ng/dL .


Preincubation with flutamide reduced the TNF response by 60 % 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 331 patients with intermittent claudication or ischemic rest pain attributable to superficial femoral and popliteal peripheral artery disease were randomly assigned in a 2:1 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 12 months .


Baseline characteristics were similar between the 2 groups .


Mean lesion length and the percentage of total occlusions for the DCB and PTA arms were 8.94 4.89 and 8.81 5.12 cm ( P = 0.82 ) and 25.8 % and 19.5 % ( P = 0.22 ) , respectively .


DCB resulted in higher primary patency versus PTA ( 82.2 % versus 52.4 % ; P < 0.001 ) .


The rate of clinically driven target lesion revascularization was 2.4 % in the DCB arm in comparison with 20.6 % in the PTA arm ( P < 0.001 ) .


There was a low rate of vessel thrombosis in both arms ( 1.4 % after DCB and 3.7 % after PTA [ P = 0.10 ] ) .


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 .


http://www.clinicaltrials.gov .


Unique Identifiers : NCT01175850 and NCT01566461 .


We investigated the effect of Nitrous Oxide ( N2O ) 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 ( 0.1 g.kg-1 .


min-1 ) for 10 minutes .


Next , we continued it until the last 30 minutes of the operation at a dose of 0.7 g.kg ( -1 ) .


hour ( -1 ) .


We administered thiopental ( 4-6 mg .


kg ( -1 ) ) and 0.08-0 .12 mg.kg ( -1 ) vecuronium bromide at induction for both groups .


We used isoflurane ( 2 % ) for anesthesia maintenance .


Group N received a 50 % O2-N2O mixture and Group A received 50 % O - air mixture as carrier gas .


We started low-flow anesthesia ( 1 L.min ( -1 ) ) after a 10-minute period of initial high flow ( 4.4 L.min ( -1 ) ) .


We recorded values for blood pressure , heart rate , peripheral O2 saturation , inspiratory isoflurane , expiratory isoflurane , inspiratory O2 , expiratory O2 , inspiratory N2O , expiratory N2O , inspiratory CO2 , CO2 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 , 10 , and 15 minutes .


After intubation , the patients reached desired hypotension values at minute five for Group N and at minute 20 for group A. MAC values were higher for Group N at minute one , three , five , 10 , and 15 ( p < 0.05 ) .


FiO2 values were high between minute five and 60 for Group A , while at minute 90 Group N values were higher ( p < 0.05 ) .


Fi Iso ( inspiratuvar isofluran ) values were lower in Group N at minute 15 and 30 ( p < 0.05 ) .


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 = 232 ; mean age SD , 799.4 y ) were randomly assigned to intervention ( n = 120 , 51.7 % ) and attention control ( n = 112 , 48.3 % ) groups .


The 6-month intervention , the Home-based Post-Hip Fracture Rehabilitation , is a functionally oriented , home-based exercise program .


Data were collected at baseline , postintervention ( 6mo ) , and follow-up ( 9mo ) .


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 9 months ( indirect = .21 ) .


Similarly , the mediating effect of the intervention on Daily Activity function through self-efficacy for exercise was significant at 9 months ( indirect = .49 ) .


In subgroup analyses , the mediating effect was significant at 9 months in the younger group ( age , 79y ) 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-2b 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-2a .


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-2a .


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


Reductions in HBV-DNA were not significantly different , except the 1200g every 4 weeks albinterferon dose which was inferior compared with pegylated-interferon-2a .


The serum alanine aminotransferase levels decreased in all arms .


The per-patient incidence of adverse events was not significantly different for albinterferon ( 96.4-100 % ) and pegylated-interferon-2a ( 93.1 % ) .


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


Decreased lung function was found in all arms ( 93 % of patients ) , and was more common in some albinterferon groups .


Albinterferon doses with similar anti-HBV efficacy to pegylated-interferon-2a had higher rates of certain adverse events , particularly changes in lung diffusion capacity ( http://www.clinicaltrials.gov number NCT00964665 ) .


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 2012 and February 2013 , 100 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 [ median 23 ( 5-92 ) vs. 15 ( 5-37 ) , P < 0.001 ] , with only one specimen not achieving the recommended minimum standard of 12 nodes [ 1/50 ( 2 % ) vs. 8/50 ( 16 % ) , P = 0.014 ] .


However , there was no upstaging effect in the intervention group [ 23/50 ( 46.0 % ) vs. 20/50 ( 40.0 % ) ; P = 0.686 ] .


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 [ median 30 nodes ( 12-57 ) vs. 11 ( 7-15 ) ; P = 0.011 ; proportion of cases with < 12 nodes 0/5 vs. 5/8 ( 62.5 % ) , P = 0.024 ] .


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 50 and ED 95 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 4 mg , 6 mg , 8 mg , or 10 mg intrathecal hyperbaric bupivacaine with 2.5 g sufentanil .


Successful spinal anesthesia was defined as a T6 sensory level achieved within 10 minutes after intrathecal drug administration and/or no epidural supplement was required during the cesarean section .


The ED 50 and ED 95 were calculated with a logistic regression model .


ED 50 and ED 95 of intrathecal bupivacaine for successful spinal anesthesia were 5.67 mg ( 95 % confidence interval [ CI ] : 5.20-6 .10 mg ) and 8.82 mg ( 95 % CI : 8.14-9 .87 mg ) respectively .


The incidence of hypotension in Group 8 mg and Group 10 mg was higher than that in Group 4 mg and Group 6 mg ( P < 0.05 ) .


The sensory block was significantly different among groups 10 minutes after intrathecal injection ( P < 0.05 ) .


The use of lidocaine in Group 4 mg was higher than that in other groups ( P < 0.05 ) .


The use of phenylephrine in Group 8 mg and Group 10 mg was higher than that in the other two groups ( P < 0.05 ) .


The lowest systolic blood pressure before the infant delivery of Group 8 mg and Group 10 mg was lower than the other two groups ( P < 0.05 ) .


The satisfaction of muscle relaxation in Group 4 mg was lower than other groups ( P < 0.05 ) .


There was no significant difference in patients ' satisfaction and the newborns ' Apgar score and the blood gas analysis of umbilical artery serum ( P > 0.05 ) .


Our study showed that the ED 50 and ED 95 of intrathecal bupivacaine for severely preeclamptic patients undergoing elective cesarean delivery were 5.67 mg and 8.82 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 5794 individuals with COPD and a measurement of C reactive protein ( CRP ) in the Copenhagen General Population Study ( 2003-2008 ) .


During 3years 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 ( > 3mg/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 = 0.68 ( 95 % CI 0.51 to 0.91 , p = 0.01 ) , as well as in multivariable conditional logistic regression analysis , OR = 0.67 ( 0.48 to 0.92 , p = 0.01 ) .


However , in the subgroup with the most severe COPD and without cardiovascular comorbidity , we observed a null association between statin use and exacerbations , OR = 1.1 ( 0.5 to 2.1 , p = 0.83 ) .


Furthermore , statin use was associated with reduced odds of a high CRP , OR = 0.69 ( 0.56 to 0.85 , p < 0.001 ) , and a high CRP was associated with an increased risk of exacerbations , HR = 1.62 ( 1.35 to 1.94 , p < 0.001 ) .


We estimated the percentage of excess risk of the association of statin use with exacerbations possibly mediated through a reduction of CRP to be 14 % ( 4-51 % ) .


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 3-5 years ( 7 males ) with stable asthma were recruited .


Of these , 10 children ( 6 males ) completed both arms of the study .


A transmission scan of each compliant subject was taken using a 37 MBq ( 99m ) Tc flood source .


Actuations ( 2-3 ) of a ( 99m ) 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 18.1 ( 9.1 ) % with the facemask and 22.5 ( 7.9 ) % with the spacer mouthpiece ( p > 0.05 ) .


Peripheral lung deposition ( expressed as peripheral : central ( P : C ) ratio ) was higher in 7 out of 10 children with the facemask compared with the spacer mouthpiece : 1.3 ( 0.26 ) vs. 1.2 ( 0.35 ) ; ( p = 0.11 ) .


Head and neck deposition was higher with use of the facemask compared with the spacer mouthpiece : 19.7 ( 10.6 ) % vs. 10.8 ( 5.3 ) % ( p = 0.011 ) .


Lung deposition achieved using the spacer with facemask was higher than previously reported , with a difference of only 4.4 % 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 6-months postintervention .


Mixed methods analysis including repeated measures ANOVA of functional aerobic capacity ( VO2max ) 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 63 5 years , participated .


Gains made in VO2max were maintained at 6 months ( P < 0.05 ) .


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 8-isoprostane ( 8-epiPGF2 ) , 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 = 20 ) or LC ( n = 20 ) .


The patients had body mass index < 30 , American Society of Anesthesiologists score I or II , and no previous upper gastrointestinal surgery .


Blood samples were taken preoperatively and 6 h and 24 h postoperatively .


Levels of 8-epiPGF2 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 8-epiPGF2 were significantly higher in LSSC compared with LC at 6 h ( P = 0.003 ) and 24 h ( P < 0.001 ) .


8-epiPGF2 levels showed significant changes over time in LC ( LSSC : P = 0.720 , LC : P < 0.001 ) .


UA levels were significantly higher in LC compared with LSSC , 24 h postoperatively ( P = 0.021 ) .


No significant changes over time in the UA levels in both groups ( LSSC : P = 0.056 , LC : P = 0.205 ) .


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 1 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 29 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 6-9 months of diagnosis is common .


Approximately 75 % of infants have MLL-rearranged ( MLL-R ) ALL with event free survival ( EFS ) ranging from 20 % to 30 % .


Children 's Oncology Group ( COG ) P9407 used shortened ( 46 weeks ) , intensified therapy to address early relapse and poor EFS .


P9407 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 5-year EFS and OS of 42.36 % and 52.96.5 % respectively .


Poor prognostic factors included age 90 days at diagnosis , MLL-R ALL and white cell count 50,000 / l. For infants 90 days of age , the 5-year EFS was 15.510.1 % and 48.56.7 % for those > 90 days ( P < 0.0001 ) .


Among infants > 90 days of age , 5-year EFS rates were 43.88 % for MLL-R versus 69.113.6 % for MLL-germline ALL ( P < 0.0001 ) .


Age 90 days at diagnosis was the most important prognostic factor .


Despite shortened therapy with early intensification , EFS remained less than 50 % 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 = 63 ) were randomly assigned to either rehabilitation in the clinic followed by computer-assisted home exercises ( intervention group : n = 32 ) or rehabilitation in the clinic followed by home exercises according to printed instructions ( control group : n = 31 ) .


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


Measurements at baseline and at 8 and 16 weeks were compared .


These included the One Leg Stand Test , Dynamic Gait Index , Chair Stand Test , Motion Sensitivity Test , Short Form-12 , Dizziness Handicap Inventory , and visual analog scale .


Both groups improved significantly during 16 weeks of rehabilitation .


However , neither t tests nor repeated-measures analysis of variance demonstrated any significant differences between the 2 groups .


The overall compliance rate to computer program exercises during 16 weeks was 57 % .


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 100 patients with drug-resistant AF to an oesophageal cooling group or a control group .


In the oesophageal cooling group , we injected 5 mL of ice water into the oesophagus prior to radiofrequency ( RF ) energy delivery adjacent to the oesophagus .


If the oesophageal temperature reached 42C , 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 1 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 > 42C were 1.7 1.4 and 2.6 1.7 in the oesophageal cooling group and the control group , respectively ( P = 0.04 ) , and the maximal oesophageal temperature at those sites was 43.0 0.6 and 44.7 0.9 C ( P < 0.0001 ) .


Oesophageal lesions occurred almost equally between the oesophageal cooling group [ 10 of 50 patients ( 20 % ) ] and the control group [ 11 of 50 patients ( 22 % ) ] .


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 ( 2.46 + / - 1.40 vs. 1.71 ?


0.61 , P = 0.016 ; 9.69 + / - 6.99 vs. 2.14 + / - 0.72 , P < 0.001 ; 11.17 + / - 8.60 vs 2.18 + / - 0.90 , P < 0.001 ; 0.76 + / - 0.08 vs. 0.63 + / - 0.10 , P < 0.001 ) .


On the other hand , there was a significant decrease in aortic strain and aortic distensibility ( 7.41 ?


6.82 vs 18.26 + / - 5.83 , P < 0.001 ; 1.83 + / - 1.71 vs. 5.22 + / - 1.72 , P < 0.001 , respectively ) .


No difference was observed between the two groups with respect to the left ventricular myocardial performance index ( MPI ) ( 0.62 + / - 0.15 vs. 0.61 + / - 0.13 , P = 0.859 ) .


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 12-month follow-up and with fewer depressive symptoms up to 5 years after study enrollment .


This 8 - to 15-year follow-up ( median , 11 years ) of a previously conducted trial ( NCT01422551 ) evaluated whether women in this cohort receiving CBSM had fewer depressive symptoms and better QOL than controls at an 8 - to 15-year follow-up .


Women with stage 0 to IIIb breast cancer were initially recruited 2 to 10 weeks after surgery and randomized to a 10-week CBSM intervention or a 1-day psychoeducational control group .


One hundred women ( 51 CBSM patients and 49 controls ) were recontacted 8 to 15 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 , 0.63 ; 95 % confidence interval [ CI ] , 0.56-0 .70 ) and better QOL ( d , 0.58 ; 95 % CI , 0.52-0 .65 ) 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 15 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 24 months .


Outpatients with social anxiety disorder who were treated with CBT ( N = 209 ) or psychodynamic therapy ( N = 207 ) in the previous trial were assessed 6 , 12 , and 24 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 70 % by the 2-year follow-up .


Remission rates were nearly 40 % for both treatment conditions .


Rates of response and remission were stable or tended to increase for both treatments over the 24-month follow-up period , and no significant differences were found between the treatment conditions after 6 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 1994 to 1998 randomized 4604 volunteer public housing families with 3689 children in high-poverty neighborhoods into 1 of 2 housing mobility intervention groups ( a low-poverty voucher group vs a traditional voucher group ) or a control group .


The low-poverty voucher group ( n = 1430 ) received vouchers to move to low-poverty neighborhoods with enhanced mobility counseling .


The traditional voucher group ( n = 1081 ) received geographically unrestricted vouchers .


Controls ( n = 1178 ) received no intervention .


Follow-up evaluation was performed 10 to 15 years later ( June 2008-April 2010 ) with participants aged 13 to 19 years ( 0-8 years at randomization ) .


Response rates were 86.9 % to 92.9 % .


Presence of mental disorders from the Diagnostic and Statistical Manual of Mental Disorders ( Fourth Edition ) within the past 12 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 3689 adolescents randomized , 2872 were interviewed ( 1407 boys and 1465 girls ) .


Compared with the control group , boys in the low-poverty voucher group had significantly increased rates of major depression ( 7.1 % vs 3.5 % ; odds ratio ( OR ) , 2.2 [ 95 % CI , 1.2-3 .9 ] ) , PTSD ( 6.2 % vs 1.9 % ; OR , 3.4 [ 95 % CI , 1.6-7 .4 ] ) , and conduct disorder ( 6.4 % vs 2.1 % ; OR , 3.1 [ 95 % CI , 1.7-5 .8 ] ) .


Boys in the traditional voucher group had increased rates of PTSD compared with the control group ( 4.9 % vs 1.9 % , OR , 2.7 [ 95 % CI , 1.2-5 .8 ] ) .


However , compared with the control group , girls in the traditional voucher group had decreased rates of major depression ( 6.5 % vs 10.9 % ; OR , 0.6 [ 95 % CI , 0.3-0 .9 ] ) and conduct disorder ( 0.3 % vs 2.9 % ; OR , 0.1 [ 95 % CI , 0.0-0 .4 ] ) .


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 [ meanSD ] 36.74.9 kg/m ( 2 ) ) were randomized between 7 and 21 weeks ' ( 14.92.6 ) gestation to intervention ( n = 56 ) or usual care control conditions ( n = 58 ) .


The intervention included individualized calorie goals , advice to maintain weight within 3 % 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 2 weeks postpartum and from randomization to 34 weeks gestation , and newborn large-for-gestational age ( birth weight > 90th percentile , LGA ) .


Intervention participants gained less weight from randomization to 34 weeks gestation ( 5.0 vs. 8.4 kg , mean difference = -3.4 kg , 95 % CI [ -5.1 -1.8 ] ) , and from randomization to 2 weeks postpartum ( -2.6 vs. +1.2 kg , mean difference = -3.8 kg , 95 % CI [ -5.9 -1.7 ] ) .


They also had a lower proportion of LGA babies ( 9 vs. 26 % , odds ratio = 0.28 , 95 % CI [ 0.09-0 .84 ] ) .


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 2 diabetes mellitus ( T2DM ) .


Ninety subjects with T2DM were divided randomly into a control group ( n = 30 ) , aerobic exercise group ( n = 30 ) , or Acu-TENS group ( n = 30 ) .


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 30 min for each session and five times a week for 2 months .


The indices of glycosylated hemoglobin , 2 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 2 months after treatment .


The indices of the control group were not changed ( P > 0.05 ) at the three time points .


At the pre-treatment measurement , there were significant differences ( P > 0.05 ) in indices among the three groups .


At post-treatment , each index of the two groups was lower than that of the control group ( P < 0.05 ) , and improved in comparison with the pre-treatment measurement ( P < 0.05 ) .


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 < 0.05 ) , excluding body mass index .


Acu-TENS could improve the state of patients with T2DM 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 60 kHz or the Visumax 500 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 60 kHz laser in 1 eye and the 500 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 50.0 % of 60 kHz laser cases and 0 % of 500 kHz laser cases during docking and in 63.0 % and 0 % of cases , respectively , during laser flap creation ( P < .0001 ) .


The mean pain score with the 60 kHz laser was significantly higher during docking ( P < .0001 ) but not during laser flap cutting ( P = .006 ) .


Subconjunctival hemorrhage occurred in 67.4 % of eyes with the 60 kHz laser and in 2.2 % of eyes with the 500 kHz laser ( P < .0001 ) .


The 500 kHz laser was preferred by 78.3 % of patients , while 21.7 % preferred the 60 kHz laser ( P < .0001 ) .


The surgeons preferred the 60 kHz laser in 50.0 % of cases and the 500 kHz laser in 8.7 % ( P < .0001 ) ; 41.3 % had no preference .


Patients preferred surgery with the 500 kHz laser with no loss of light perception , less pain , less fear , and less subconjunctival hemorrhage .


Surgeons preferred the 60 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 3-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 ( 26 % leg length ) , and wider ( 39 % leg length ) SW .


The preferred normalized SW in older adults during stair descent was 20 % 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 3 months in 2514 patients with AF in the RE-LY trial ; median follow-up was 2.0 years .


Patients were grouped based on levels at the two time points according to detectable cTnI levels ( 0.01 g/L ) or NT-proBNP levels above median ( 778 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 48.5 % , at one time point 28.5 % and at neither time point 21.0 % .


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 < 0.005 , effect of cTnI ) .


Persistent elevation of either or both cardiac biomarkers at baseline and 3 months was associated with a higher risk for cardiovascular events and mortality ( p < 0.0001 ) .


Prognostic prediction improved most with the use of repeated measurements of both cardiac biomarkers simultaneously ( p < 0.05 ) and achieved C-statistic 0.644 for stroke compared with 0.611 for CHADS2-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 .


http://www.clinicaltrials.gov , NCT00262600 .


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 .


TRO40303 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 , TRO40303 was tested in a model of isolated rat heart .


Additionally , TRO40303 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 ( 0.5 to 13 mg/kg ) in 72 healthy male , post-menopausal and hysterectomized female subjects at flow rates from 0.04 to 35 mL/min ( EudraCT number : 2010-021453-39 ) .


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


In the vivo model , TRO40303 reduced infarct size by 40 % at 1 mg/kg and by 50 % at 3 and 10 mg/kg given by intravenous bolus and was only active when administered before reperfusion .


Additionally , TRO40303 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 6 mg/kg and slightly ~ 1.5-fold , hyper-proportional from 6 to 13 mg/kg .


These data demonstrated that TRO40303 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 6 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 2012 the entire 75 and older population ( N = 3,275 ) 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 = 250 ) will be enrolled in a 12-month randomized controlled trial with three arms : 1 ) no supplementation , 2 ) protein supplementation ( 20 grams twice a day ) , and 3 ) isocaloric placebo .


All the participants will receive instructions on simple home-based exercises , dietary protein , and vitamin D supplementation ( 20 g/d ) .


The recruitment of patients will be completed during 2013 .


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 0 , 6 , 12 and 24 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 .


ACTRN12612001253897 , date of registration 28 October 2012 , first patient was randomized 11 April 2012 .


AST-120 ( 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-120 in a Western population , a phase 3 , multicenter , randomized , double-blind , placebo-controlled , study ( FHAST-1 ) was conducted in adult patients with at least 1 draining perianal fistula and a Crohn 's disease activity index < 400 .


Patients received either AST-120 or matching placebo at a dose of 2 g 3 times daily for 8 weeks .


The primary endpoint was the proportion of patients with treatment success , defined as a 50 % reduction in the number of draining fistulae , at both weeks 4 and 8 .


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


Two hundred forty-nine patients were randomized ( AST-120 ; n = 122 ; placebo , n = 127 ) .


The proportions of patients achieving the primary endpoint were no different between treatment groups ( 13.9 % versus 16.5 % , P = 0.6 ) .


No differences in fistula response were noted at week 4 ( 23.0 % versus 25.2 % , P = 0.77 ) or week 8 ( 27.0 versus 34.6 % , P = 0.22 ) .


Serum C-reactive protein concentrations > 0.6 mg/dL and Crohn 's disease activity index scores > 151 at baseline were associated with a reduced likelihood of treatment success ( odds ratio , 0.40 ; confidence interval , 0.19-0 .87 ; P = 0.02 ; and odds ratio , 0.45 ; confidence interval , 0.21-0 .97 ; P = 0.04 , 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-120 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 = 24 ) and patients ( N = 24 ) with chronic low back pain .


Two hospital clinics were randomly assigned to the intervention arm .


Physiotherapists ( n = 12 ) received 8 hours of communication skills training focused on supporting patients ' psychological needs .


Physiotherapists ( n = 12 ) from 2 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 = 2.27 ; P < .01 ) .


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 2000 .


We included 51,093 subjects with stroke as cases and randomly selected 153,279 controls ( 3 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 3,685 study subjects ( 1.81 % ) had been diagnosed with IDA prior to the index date ; of those subjects , 1,268 ( 2.48 % ) were cases and 2,417 ( 1.58 % ) were controls ( p < 0.001 ) .


Conditional logistic regression shows that the OR of having previously received an IDA diagnosis among cases was 1.49 ( 95 % CI : 1.39 ~ 1.60 ; p < 0.01 ) 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 1.45 ( 95 % CI : 1.34 ~ 1.58 ) compared to controls .


However , we did not find any significant relationship between IDA and subarachnoid/intracerebral hemorrhage even adjusting for other confounding factors ( OR = 1.17 , 95 % CI = 0.97 ~ 1.40 ) .


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 1-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 2008 and November 2009 , 164 participants were randomised .


Primary outcome data were available at 1year for 131 ( 80 % ) .


The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted , with a slight reduction in standardised effect sizes ( SES ) ( -0.29 , p = 0.06 and 0.34 , p = 0.09 , respectively ) .


There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months ( SES -0.24 , p = 0.046 ) .


No adverse events were reported .


Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1year with additional improvements in MS impact .


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


ISRCTN76517470 .


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 62961 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 R2 resections .


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


From 341 patients , 149 ( median age 52 years , 18-69 ) were identified with macroscopic complete resection ( R0 , R1 ) of abdominal and retroperitoneal soft-tissue sarcomas ( median diameter 10 cm , G2 48.3 % , G3 51.7 % ) .


Seventy-six patients were treated with EIA ( etoposide , ifosfamide , doxorubicin ) + RHT ( 5 cycles : 69.7 % ) versus 73 patients receiving EIA alone ( 5 cycles : 52.1 % , P = 0.027 ) .


LPFS and DFS as well as overall survival were determined .


RHT and systemic chemotherapy significantly improved LPFS ( 56 % vs 45 % after 5 years , P = 0.044 ) and DFS ( 34 % vs 27 % after 5 years , P = 0.040 ) .


Overall survival was not significantly improved in the RHT group ( 57 % vs 55 % after 5 years , P = 0.82 ) .


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 , 27 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 11 ) , Neiguan ( PC 6 ) , Zusanli ( ST 36 ) , Sanyinjiao ( SP 6 ) and Taichong ( LR 3 ) .


Acupuncture was given at the admission , 4 h , 6 h and 12 h after disease onset respectively .


Blood pressure was monitored in the whole procedure .


6 h and 24 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 .


( 1 ) Blood pressure : from the admission to 12 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 [ ( 164.3 + / - 21.6 ) mmHg vs ( 158.6 + / - 21.5 ) mmHg ] and MAP [ ( 113.4 + / - 4.9 ) mmHg vs ( 106.7 + / - 6.1 ) mmHg ] were significant between the two groups ( both P < 0.05 ) .


From 12 h to 24 h after disease onset , compared with the conventional treatment group , SBP and MAP were decreased apparently in the acupuncture group [ ( 147.3 + / - 21.6 ) mmHg vs ( 158.4 + / - 23.5 ) mmHg , ( 97.2 + / - 5.3 ) mmHg vs ( 106.6 + / - 5.1 ) mmHg , both P < 0.05 ) ] .


( 2 ) Hematoma volume : from the admission to 6 h after disease onset , the volume was increased by ( 4.15 + / - 0.73 ) mL in the convertional treatment group and ( 2.67 + / - 0.33 ) mL in the acupuncture group , indicating the significant difference in comparison ( P < 0.05 ) .


From the admission to 24 h after disease onset , it was increased by ( 5.57 + / - 1.26 ) mL in the convertional treatment group and ( 3.14 + / - 1.18 ) mL in the acupuncture group , indicating the significant difference in comparison ( P < 0.05 ) .


( 3 ) Neurological deficit score : the score was increasing gradually in first 3 days after disease onset in the two groups .


The score ( 38.39 + / - 6.84 ) in the acupuncture group on the first day was different significantly as compared with that ( 42.37 + / - 7.46 ) in the conventional treatment group ( P < 0.05 ) .


On the 10th days , the score ( 24.68 + / - 5.42 ) in the acupuncture group was different significantly from that ( 29.74 + / - 7.36 ) in the convertional treatment group ( P < 0.05 ) .


There is no peak of blood pressure rising , and the continuous hemorrhagic volume is less in 24 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 2 diabetes inadequately controlled on basal insulin plus oral antidiabetic drugs .


The FullSTEP study was a phase 4 , 32-week , randomised , open-label , two-arm , parallel-group , multinational , treat-to-target , non-inferiority trial done at 150 sites across seven countries to assess the effectiveness of a stepwise dosing approach versus a basal-bolus regimen .


In this trial , 401 patients ( mean age 598 years [ SD 93 ] ; HbA1c 79 % [ 63 mmol/mol ] ; mean diabetes duration 126 years [ SD 80 ] ) were block randomised ( ratio 1:1 ) 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 11 weeks and 22 weeks if HbA1c remained at 7 % or higher .


The primary outcome was non-inferiority of stepwise addition of bolus insulin versus complete basal-bolus therapy , as assessed by change in HbA1c from baseline to 32 weeks ( non-inferiority margin of 04 % ) .


This trial is registered with ClinicalTrials.gov , number NCT01165684 .


The study was started on Oct 27 , 2010 , and completed on April 25 , 2012 .


After 32 weeks , HbA1c change from baseline was -098 % ( 95 % CI -109 to -087 ) for the stepwise group and -112 % ( -123 to -100 ) for the basal-bolus group ; mean treatment difference 014 ( 95 % CI -002 to 030 ) , non-significant ( p = 00876 ) .


Fewer hypoglycaemic episodes occurred in the stepwise group than in the basal-bolus group ( rate ratio 058 [ 95 % CI 045 to 075 ] ; p < 00001 ) .


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 32 weeks , with significantly lower hypoglycaemia risk and better patient satisfaction .


Novo Nordisk .


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


This study compared the efficacy of the new phosphodiesterase type 5 inhibitor udenafil with that of the calcium channel blocker amlodipine in the treatment of secondary RP .


A total of 29 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 100 mg/day or amlodipine 10 mg/day for 4 weeks .


After a washout period they were crossed over to the other drug for another 4 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 = 0.021 ) .


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 .


www.clinicaltrials.gov , protocol number NCT01280266 .


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 164 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 1year 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 = 0.03 ) , 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 .


IRCT201103146061N1 .


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 NCT00156624 ) were analyzed to compare degrees of dissection and angiographic parameters between the control ( uncoated balloons , n = 43 ) and treatment ( PCBs , n = 43 ) groups before and after the intervention and at 6-month follow-up .


Furthermore , target lesion revascularizations ( TLR ) were documented up to 2 years .


In each group , 24 ( 56 % ) patients had a dissection after the intervention .


At the 6-month follow-up , patients with dissection of any grade after treatment with PCBs had significantly less late lumen loss ( 0.4 mm ) than patients with dissection after treatment with uncoated balloons ( 1.9 mm , p = 0.001 ) and a lower degree of stenosis ( 20 % vs. 51 % , respectively ; p = 0.003 ) .


Patients with severe dissection ( grades C , D , or E ) especially seemed to benefit from the PCBs , with late lumen loss of 0.4 mm vs. 2.4 mm for controls ( p = 0.05 ) .


The binary restenosis rate was also markedly lower in the PCB group ( 20 % ) than in the uncoated group ( 55 % , p = 0.02 ) .


In the 2-year follow-up , TLR was performed in 56 % of patients in the control group compared to 10 % of patients in the PCB group ( p = 0.002 ) .


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 , 24 to a wait-list control .


Main outcome measures included error processing ( ERN , Pe ) , conflict monitoring ( NoGo-N2 ) , and inhibitory control ( NoGo-P3 ) 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-P3 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 P3 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 = 16 ) and control group ( C , n = 23 ) .


Bosentan was applied within 7 days after Fontan surgery as follows : at the first month , 7.8125 mg Bid for patients with body weight 10 kg ; 15.625 mg Bid for patients with body weight between 10-20 kg ; 31.25 mg Bid for patients with body weight 20-30 kg and 62.5 mg Bid for patients with body weight > 30 kg .


At the second month , the bosentan dose was doubled and Bosentan therapy was continued for more than 1 year .


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


All patients were followed up for 2 years and incidence of mortality , protein losing enteropathy , pulmonary arteriovenous fistulae , 6-minute walk test , heart function were compared between the two groups .


After 2 years , mortality tended to be lower in group B compared to group C [ 6.25 % ( 1/16 ) vs. 21.8 % ( 5/23 ) , P > 0.05 ] .


Incidence of pulmonary arteriovenous fistulae and protein losing enteropathy were significantly lower in group B than in group C ( 6.25 % vs. 34.78 % , P = 0.01 ; 6.25 % vs. 39.13 % , P = 0.02 , respectively ) .


The results of 6-minute walk test [ ( 485 44 ) m vs. ( 302 183 ) m ] and heart function in group B ( 3 NYHA III/IV patients in group B vs. 14 NYHA III/IV patients in group C , all P < 0.05 ) were all better than group C.


The concentrations of vasoactive factors such as brain natriuretic peptide ( BNP , 279.07 128.17 vs. 457.67 221.30 ) , endothelin ( ET , 3.30 0.61 vs. 4.98 1.24 ) and thromboxane ( TXA2 , 97.2 24.0 vs. 163.22 24.4 ) were also significantly lower in group B than in group C ( all P < 0.05 ) .


Prostacyclin ( PGI2 ) 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 33 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 3 and 6months 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 3months , 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-18 3 ' - deoxy-3 ' - fluorothymidine positron emission tomography ( ( 18 ) FLT-PET ) .


During a lead-in period , patients received twice daily ( b.i.d. ) axitinib 7 mg ( n = 3 ) or 10 mg ( n = 18 ) for 7 days followed by a 7-day dosing interruption ; serial ( 18 ) FLT-PET scans were performed before day 1 and on days 7 , 10 , and 14 .


Axitinib plus FOLFIRI or FOLFOX was then administered in 2-week cycles ; axitinib was interrupted on day 10 of each cycle for 7 days .


The maximum tolerated dose of axitinib was 10 mg b.i.d. , in a week-on/week-off schedule , combined with FOLFIRI or FOLFOX .


Common all-causality grade 3 adverse events were neutropenia ( 38 % ) , hypertension ( 33 % ) , and fatigue ( 29 % ) .


Of 21 patients , 2 ( 10 % ) had a partial response and 12 ( 57 % ) had stable disease .


Following 7 days of continuous axitinib dosing , tumour ( 18 ) FLT uptake decreased -49 % from baseline and recovered to -28 % and -17 % from baseline , respectively , after 3 and 7 days of axitinib interruption .


Axitinib administered in a week-on/week-off schedule combined with FOLFIRI or FOLFOX is supported by ( 18 ) 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 = 124 ) with LBP ( 12 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 0 ( before treatment ) , Week 7 ( after the 6-week 1-hour treatment sessions ) , and 12 months .


Using the Oswestry disability index ( 0-100 ) and the Numeric Pain Rating Scale ( 0-10 ) , 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 3:1 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 , 76 received a matched treatment and 25 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 7 or 12 months , except on one of the secondary measures ( Graded Chronic Pain Scale [ Disability Scale ] ) ( p = .01 ) .


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 20 ml of 0.75 % 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 2 mg [ 0-3 ] in the ropivacaine vs. 4 mg [ 3-6 ] in the placebo group ( P = 0.0004 , 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 .