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CONCLUSIONS | ( Funded by Inspire Medical Systems ; STAR ClinicalTrials.gov number , NCT01161420 . ) |
###26126563 | null |
OBJECTIVE | To identify facilitators and barriers to clinical trial implementation in Aboriginal health services . |
METHODS | Indepth interview study with thematic analysis . |
METHODS | Six Aboriginal community-controlled health services and one government-run service involved in the Kanyini Guidelines Adherence with the Polypill ( KGAP ) study , a pragmatic randomised controlled trial that aimed to improve adherence to indicated drug treatments for people at high risk of cardiovascular disease . |
METHODS | 32 health care providers and 21 Aboriginal and Torres Strait Islander patients . |
RESULTS | A fundamental enabler was that participants considered the research to be governed and endorsed by the local health service . |
RESULTS | That the research was perceived to address a health priority for communities was also highly motivating for both providers and patients . |
RESULTS | Enlisting the support of Aboriginal and Torres Strait Islander staff champions who were visible to the community as the main source of information about the trial was particularly important . |
RESULTS | The major implementation barrier for staff was balancing their service delivery roles with adherence to often highly demanding trial-related procedures . |
RESULTS | This was partially alleviated by the research team 's provision of onsite support and attempts to make trial processes more streamlined . |
RESULTS | Although more intensive support was highly desired , there were usually insufficient resources to provide this . |
CONCLUSIONS | Despite strong community and health service support , major investments in time and resources are needed to ensure successful implementation and minimal disruption to already overstretched , routine services . |
CONCLUSIONS | Trial budgets will necessarily be inflated as a result . |
CONCLUSIONS | Funding agencies need to consider these additional resource demands when supporting trials of a similar nature . |
###24693629 | null |
OBJECTIVE | To compare the effect of incomplete caries removal ( ICR ) and indirect pulp capping ( IPC ) with calcium hydroxide ( CH ) or an inert material ( wax ) on color , consistency and contamination of the remaining dentin of primary molars . |
METHODS | This double-blind , parallel-design , randomized controlled trial included 30 children presenting one primary molar with deep caries lesion . |
METHODS | Children were randomly assigned after ICR to receive IPC with CH or wax . |
METHODS | All teeth were then restored with resin composite . |
METHODS | Baseline dentin color and consistency were evaluated after ICR , and dentin samples were collected for contamination analyses using scanning electron microscopy . |
METHODS | After 3 months , restorations were removed and the three parameters were re-evaluated . |
METHODS | In both groups , dentin became significantly darker after 3 months . |
RESULTS | No cases of yellow dentin were observed after 3 months with CH compared to 33.3 % of the wax cases ( P < 0.05 ) . |
RESULTS | A statistically significant difference over time was observed only for CH regarding consistency . |
RESULTS | CH stimulated a dentin hardening process in a statistically higher number of cases than wax ( 86.7 % vs. 33.3 % ; P = 0.008 ) . |
RESULTS | Contamination changed significantly over time in CH and wax without significant difference between groups . |
RESULTS | It was concluded that CH and wax arrested the carious process of the remaining carious dentin after indirect pulp capping , but CH showed superior dentin color and consistency after 3 months . |
###24996519 | null |
BACKGROUND | In literature there is a general consensus that the use of the mirror improves proprioception . |
BACKGROUND | During rehabilitation the mirror is an important instrument to improve stability . |
BACKGROUND | In some sports , such as dancing , mirrors are widely used during training . |
BACKGROUND | The purpose of this study is to evaluate the effectiveness of the use of a mirror on balance in young dancers . |
BACKGROUND | Sixty-four young dancers ( ranging from 9-10 years ) were included in this study . |
BACKGROUND | Thirty-two attending lessons with a mirror ( mirror - group ) were compared to 32 young dancers that attended the same lessons without a mirror ( non-mirror group ) . |
BACKGROUND | Balance was evaluated by BESS ( Balance Error Scoring System ) , which consists of three stances ( double limb , single limb , and tandem ) on two surfaces ( firm and foam ) . |
BACKGROUND | The errors were assessed at each stance and summed to create the two subtotal scores ( firm and foam surface ) and the final total score ( BESS ) . |
BACKGROUND | The BESS was performed at recruitment ( T0 ) and after 6months of dance lessons ( T1 ) . |
RESULTS | The repeated measures ANOVA analysis showed that for the BESS total score there is a difference due to the time ( F = 3.86 ; p < 0.05 ) . |
RESULTS | No other differences due to the group or to the time of measurement were found ( p > 0.05 ) . |
RESULTS | The analysis of the multiple regression model showed the influence of the values at T0 for every BESS items and the dominance of limb for stability on an unstable surface standing on one or two legs . |
CONCLUSIONS | These preliminary results suggest that the use of a mirror in a ballet classroom does not improve balance acquisition of the dancer . |
CONCLUSIONS | On the other hand , improvement found after 6months confirms that at the age of the dancers studied motor skills and balance can easily be trained and improved . |
###25440306 | null |
OBJECTIVE | Long-term follow-up studies documenting maintenance of treatment effects are fewin adolescent anorexia nervosa ( AN ) . |
OBJECTIVE | This exploratory study reports relapse from full remission and attainment of remission during a 4-year open follow-up period using a convenience sample of a subgroup of 65 % ( n = 79 ) from an original cohort of 121 participants who completed a randomized clinical trial comparing family-based therapy ( FBT ) and adolescent-focused individual therapy ( AFT ) . |
METHODS | Follow-up assessments were completed up to 4years posttreatment ( average , 3.26 years ) . |
METHODS | Available participants completed the Eating Disorder Examination as well as self-report measures of self-esteem and depression at 2 to 4 years posttreatment . |
RESULTS | Two participants ( 6.1 % ) relapsed ( FBT : n = 1 , 4.5 % ; AFT : n = 1 , 9.1 % ) , on average 1.98 years ( SD = 0.14 years ) after remission was achieved at 1-year follow-up . |
RESULTS | Ten new participants ( 22.7 % ) achieved remission ( FBT : n = 1 , 5.9 % ; AFT : n = 9 , 33.3 % ) . |
RESULTS | Mean time to remission for this group was 2.01 years ( SD = 0.82 years ) from 1-year follow-up . |
RESULTS | There were no differences based on treatment group assignment in either relapse from full remission or new remission during long-term follow-up . |
RESULTS | Other psychopathology was stable over time . |
CONCLUSIONS | There were few changes in the clinical presentation of participants who were assessed at long-term follow-up . |
CONCLUSIONS | These data suggest that outcomes are generally stable posttreatment regardless of treatment type once remission is achieved . |
CONCLUSIONS | Clinical trial registration information-Effectiveness of Family-Based Versus Individual Psychotherapy in Treating Adolescents With Anorexia Nervosa ; http://www.clinicaltrials.gov/; NCT00149786 . |
###24754891 | null |
BACKGROUND | Coronary artery bypass grafting using the radial artery has , since the 1990s , gone through a revival . |
BACKGROUND | Observational studies have indicated better long-term patency when using radial arteries . |
BACKGROUND | Therefore , radial artery might be preferred especially in younger patients where long time patency is important . |
BACKGROUND | During the last 10years different endoscopic techniques to harvest the radial artery have evolved . |
BACKGROUND | Endoscopic radial artery harvest only requires a small incision near the wrist in contrast to open harvest , which requires an incision from the elbow to the wrist . |
BACKGROUND | However , it is unknown whether the endoscopic technique results in fewer complications or a graft patency comparable to open harvest . |
BACKGROUND | When the radial artery has been harvested , there are two ways to use the radial artery as a graft . |
BACKGROUND | One way is sewing it onto the aorta and another is sewing it onto the mammary artery . |
BACKGROUND | It is unknown which technique is the superior revascularisation technique . |
METHODS | The NEO Trial is a randomised clinical trial with a 22 factorial design . |
METHODS | We plan to randomise 300 participants into four intervention groups : ( 1 ) mammario-radial endoscopic group ; ( 2 ) aorto-radial endoscopic group ; ( 3 ) mammario-radial open surgery group ; and ( 4 ) aorto-radial open surgery group.The hand function will be assessed by a questionnaire , a clinical examination , the change in cutaneous sensibility , and the measurement of both sensory and motor nerve conduction velocity at 3months postoperatively . |
METHODS | All the postoperative complications will be registered , and we will evaluate muscular function , scar appearance , vascular supply to the hand , and the graft patency including the patency of the central radial artery anastomosis . |
METHODS | A patency evaluation by multi-slice computer tomography will be done at one year postoperatively.We expect the nerve conduction studies and the standardised neurological examinations to be able to discriminate differences in hand function comparing endoscopic to open harvest of the radial artery . |
METHODS | The trial also aims to show if there is any patency difference between mammario-radial compared to aorto-radial revascularisation techniques but this objective is exploratory . |
BACKGROUND | ClinicalTrials.gov identifier : NCT01848886.Danish Ethics committee number : H-3-2012-116 . |
BACKGROUND | Danish Data Protection Agency : 2007-58-0015 / jr. n :30 -0838 . |
###24284437 | null |
BACKGROUND | Knowledge of essential amino acid requirements in infants is important because excessive intake of protein can lead to increased long-term morbidity such as obesity . |
BACKGROUND | A deficient intake may lead to suboptimal growth and impaired neurodevelopment . |
BACKGROUND | The current recommended branched-chain amino acid requirements in infants aged 0-1 mo are based on the amino acid content of human milk . |
OBJECTIVE | We quantified the requirements for isoleucine , leucine , and valine for term neonates by using the indicator amino acid oxidation method with [ 1 - ( 13 ) C ] phenylalanine as the indicator . |
METHODS | Fully enterally fed term infants received randomly graded amounts of isoleucine ( 5-216 mg kg ( -1 ) d ( -1 ) ) , leucine ( 5-370 mg kg ( -1 ) d ( -1 ) ) , or valine ( 5-236 mg kg ( -1 ) d ( -1 ) ) as part of an elemental formula . |
METHODS | Data are expressed as means SDs . |
RESULTS | Eighty-three Asian , term neonates ( mean SD birth weight : 3.3 0.4 kg ; gestational age : 39.4 1.3 wk ) were studied at a postnatal age of 13 5 d. Mean requirements for isoleucine , leucine , and valine ( measured in boys only ) were 105 mg kg ( -1 ) d ( -1 ) ( r ( 2 ) = 0.61 , P < 0.001 ) , 140 mg kg ( -1 ) d ( -1 ) ( r ( 2 ) = 0.26 , P < 0.01 ) , and 110 mg kg ( -1 ) d ( -1 ) ( r ( 2 ) = 0.35 , P = 0.001 ) , respectively . |
CONCLUSIONS | Current human milk-based recommendations for isoleucine and valine in term infants aged 0-1 mo are correct . |
CONCLUSIONS | However , the current recommendation for leucine ( 166 mg kg ( -1 ) d ( -1 ) ) is higher than the mean requirement of 140 mg kg ( -1 ) d ( -1 ) that we determined in this study . |
CONCLUSIONS | This trial was registered at www.trialregister.nl as NTR1610 . |
###25585779 | null |
OBJECTIVE | We wanted to confirm the benefit of mometasone furoate ( MF ) in preventing acute radiation reactions , as shown in a previous study ( Bostrm et al , Radiother Oncol 2001 ; 59:257 -265 ) . |
METHODS | The study was a double-blind comparison of MF with D ( Diprobase ) , administered daily from the start of radiation therapy for 5 weeks in patients receiving breast radiation therapy , 40 Gy in 2.67-Gy fractions daily over 3 weeks . |
METHODS | The primary endpoint was mean modified Radiation Therapy Oncology Group ( RTOG ) score . |
RESULTS | Mean RTOG scores were significantly less for MF than for D ( P = .046 ) . |
RESULTS | Maximum RTOG and mean erythema scores were significantly less for MF than for D ( P = .018 and P = .012 , respectively ) . |
RESULTS | The Dermatology Life Quality Index ( DLQI ) score was significantly less for MF than for D at weeks 4 and 5 when corrected for Hospital Anxiety and Depression ( HAD ) questionnaire scores . |
CONCLUSIONS | MF cream significantly reduces radiation dermatitis when applied to the breast during and after radiation therapy . |
CONCLUSIONS | For the first time , we have shown a significantly beneficial effect on quality of life using a validated instrument ( DLQI ) , for a topical steroid cream . |
CONCLUSIONS | We believe that application of this cream should be the standard of care where radiation dermatitis is expected . |
###24332668 | null |
OBJECTIVE | To compare the interstage cardiac catheterization hemodynamic and angiographic findings between shunt types for the Pediatric Heart Network Single Ventricle Reconstruction trial . |
OBJECTIVE | The trial , which randomized subjects to a modified Blalock-Taussig shunt ( MBTS ) or right ventricle-to-pulmonary artery shunt ( RVPAS ) for the Norwood procedure , demonstrated the RVPAS was associated with a smaller pulmonary artery diameter but superior 12-month transplant-free survival . |
METHODS | We analyzed the pre-stage II catheterization data for the trial subjects . |
METHODS | The hemodynamic variables and shunt and pulmonary angiographic data were compared between shunt types ; their association with 12-month transplant-free survival was also evaluated . |
RESULTS | Of 549 randomized subjects , 389 underwent pre-stage II catheterization . |