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- Edlmann, E, et al.
(författare)
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Dex-CSDH randomised, placebo-controlled trial of dexamethasone for chronic subdural haematoma: report of the internal pilot phase
- 2019
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Ingår i: Scientific reports. - : Springer Science and Business Media LLC. - 2045-2322. ; 9:1, s. 5885-
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Tidskriftsartikel (refereegranskat)abstract
- The Dex-CSDH trial is a randomised, double-blind, placebo-controlled trial of dexamethasone for patients with a symptomatic chronic subdural haematoma. The trial commenced with an internal pilot, whose primary objective was to assess the feasibility of multi-centre recruitment. Primary outcome data collection and safety were also assessed, whilst maintaining blinding. We aimed to recruit 100 patients from United Kingdom Neurosurgical Units within 12 months. Trial participants were randomised to a 2-week course of dexamethasone or placebo in addition to receiving standard care (which could include surgery). The primary outcome measure of the trial is the modified Rankin Scale at 6 months. This pilot recruited ahead of target; 100 patients were recruited within nine months of commencement. 47% of screened patients consented to recruitment. The primary outcome measure was collected in 98% of patients. No safety concerns were raised by the independent data monitoring and ethics committee and only five patients were withdrawn from drug treatment. Pilot trial data can inform on the design and resource provision for substantive trials. This internal pilot was successful in determining recruitment feasibility. Excellent follow-up rates were achieved and exploratory outcome measures were added to increase the scientific value of the trial.
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- Moreau, V., et al.
(författare)
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Pool CFD modelling : lessons from the SESAME project
- 2019
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Ingår i: Nuclear Engineering and Design. - : ELSEVIER SCIENCE SA. - 0029-5493 .- 1872-759X. ; 355
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Tidskriftsartikel (refereegranskat)abstract
- The current paper describes the Computational Fluid-Dynamics (CFD) modelling of Heavy Liquid Metal (HLM) flows in a pool configuration and in particular how this is approached within the Horizon 2020 SESAME project. SESAME's work package structure, based on a systematic approach of redundancy and diversification, is explained along with its motivation. The main achievements obtained and the main lessons learned during the project are illustrated. The paper focuses on the strong coupling between the experimental activities and CFD simulations performed within the SESAME project. Two different HLM fluids are investigated: pure lead and Lead-Bismuth Eutectic. The objective is to make CFD a valid instrument used during the design of safe and innovative Gen-IV nuclear plants. Some effort has also been devoted to Proper Orthogonal Decomposition with Galerkin projection modelling (POD-Galerkin), a reduced order model suited for Uncertainty Quantification that operates by post-processing CFD results. Assessment of Uncertainty highly improves the reliability of CFD simulations. Dedicated experimental campaigns on heavily instrumented facilities have been conceived with the specific objective to build a series of datasets suited for the calibration and validation of the CFD modelling. In pool configuration, the attention is focused on the balance between conductive and convective heat transfer phenomena, on transient test-cases representative of incidental scenarios and on the possible occurrence of solidification phenomena. Four test sections have been selected to generate the datasets: (i) the CIRCE facility from ENEA, (ii) the TALL-3D pool test section from KTH, (iii) the TALL-3D Solidification Test Section (STS) from KTH and (iv) the SESAME Stand facility from CVR. While CIRCE and TALL-3D were existing facilities, the STS and SESAME Stand facility have been conceived, built and operated within the project, heavily relying on the use of CFD support. Care has been taken to ensure that almost all tasks were performed by at least two partners. Specific examples are given on how this strategy has allowed to uncover flaws and overcome pitfalls. Furthermore, an overview of the performed work and the achieved results is presented, as well as remaining or new uncovered issues. Finally, the paper is concluded with a description of one of the main goals of the SESAME project: the construction of the Gen-IV ALFRED CFD model and an investigation of its general circulation.
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| 9. |
- Aspenberg, Per, et al.
(författare)
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Effects of Teriparatide Compared with Risedronate on Recovery After Pertrochanteric Hip Fracture Results of a Randomized, Active-Controlled, Double-Blind Clinical Trial at 26 Weeks
- 2016
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Ingår i: Journal of Bone and Joint Surgery. American volume. - : JOURNAL BONE JOINT SURGERY. - 0021-9355 .- 1535-1386. ; 98:22
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Tidskriftsartikel (refereegranskat)abstract
- Background: Osteoporosis drugs might affect fracture-healing. We therefore studied the effects of teriparatide in comparison with risedronate on recovery after pertrochanteric hip fractures. Methods: The study was a randomized, multicenter, active-controlled, 78-week trial comparing teriparatide (20 mg/day) with risedronate (35 mg/week) initiated within 2 weeks after fixation of a low-trauma pertrochanteric hip fracture (AO/OTA 31-A1 or 31-A2). The main inclusion criteria were a bone mineral density T-score of amp;lt;=-22.0 and 25-OH-vitamin D of amp;gt;= 9.2 ng/mL. During the first 26 weeks, patients received study medication with oral or injectable placebo plus calcium and vitamin D in a double-blinded fashion. Secondary (Timed Up-and-Go [TUG] test, hip pain, Short Form [SF]-36 health status, and safety) and exploratory (radiographic outcomes and ability to walk) 26-week end points are reported. Results: Of the 224 patients who were randomized, 171 (86 teriparatide, 85 risedronate) were included in the analysis. The mean age was 77 +/- 8 years, 77% were female, and 26% had a prior history of low-trauma fracture. The teriparatide group completed the TUG test in a shorter time at 6, 12, 18, and 26 weeks (differences of 25.7, -4.4, -3.1, and -3.1 seconds, respectively; p = 0.021 for the overall difference). They also reported less pain on a visual analog scale immediately after the TUG test at 12 and 18 weeks (adjusted absolute differences of 10.6 and 11.9 mm, respectively; p amp;lt; 0.05). There were no significant between-group differences in the SF-36 score, Charnley hip pain score, ability to walk, or use of walking aids during follow-up. Radiographic healing at 6, 12, and 26 weeks, mechanical failure of the implant (teriparatide, 7; risedronate, 8), loss of reduction (teriparatide, 2; risedronate, 4), and nonunion (0 cases) were not significantly different. Mild hypercalcemia and hyperuricemia were more frequent with teriparatide. Conclusions: Teriparatide was associated with less pain and a shorter time to complete the TUG test between 6 and 26 weeks compared with risedronate. Other fracture-recovery outcomes were similar. The results should be interpreted with caution as these were secondary end points.
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| 11. |
- Malouf-Sierra, Jorge, et al.
(författare)
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Effect of Teriparatide or Risedronate in Elderly Patients With a Recent Pertrochanteric Hip Fracture: Final Results of a 78-Week Randomized Clinical Trial
- 2017
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Ingår i: Journal of Bone and Mineral Research. - : WILEY. - 0884-0431 .- 1523-4681. ; 32:5, s. 1040-1051
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Tidskriftsartikel (refereegranskat)abstract
- We present final results of a study comparing teriparatide 20g every day (QD) with risedronate 35mg once per week (QW) started within 2 weeks after surgery for a pertrochanteric hip fracture. Patients with BMD T-score-2.0 and 25OHD 9.2ng/mL were randomized to receive 26-week double-dummy treatment plus calcium and vitamin D, followed by 52-week open-label treatment with the same assigned active drug. Primary endpoint was change from baseline in lumbar spine (LS) BMD at 78 weeks. Secondary and exploratory endpoints were change in BMD at the proximal femur, function, hip pain (Charnley score and 100mm Visual Analog Scale [VAS]), quality of life (Short Form-36), radiology outcomes, and safety. Data were analyzed with mixed models for repeated measures (MMRM) and logistic regression. Totally, 224 patients were randomized; 171 (teriparatide: 86) contributed to the efficacy analyses (mean +/- SD age: 77 +/- 7.7 years, 77% females). Mean baseline LS, femoral neck (FN), and total hip (TH) T-scores were -2.16, -2.63, and -2.51, respectively. At 78 weeks, BMD increased significantly more with teriparatide compared to risedronate at the LS (+11.08% versus +6.45%; pamp;lt;0.001) and FN (+1.96% versus -1.19%; p=0.003), with no significant between-group difference in TH BMD. Timed up-and-go (TUG) test was significantly faster with teriparatide at 6, 12, 18, and 26 weeks (differences: -3.2 to -5.9s; p=0.045 for overall difference). Hip pain during TUG test by 100mm VAS was significantly lower with teriparatide at 18 weeks (adjusted difference: -11.3mm, p=0.033; -10.0 and -9.3mm at 12 and 26 weeks, respectively; p=0.079 for overall difference). Other secondary and exploratory outcomes were not different. Teriparatide group showed two new hip fractures versus seven with risedronate (p=0.171) and more frequent hypercalcemia and hyperuricemia. In conclusion, 78-week treatment with teriparatide showed significantly greater increases in LS and FN BMD, less pain, and a faster TUG test versus risedronate. (c) 2016 American Society for Bone and Mineral Research.
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| 12. |
- Tudisco, Erika, et al.
(författare)
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Influence of fissure inclination and confining pressure on the local behaviour of natural clays
- 2019
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Ingår i: 7th International Symposium on Deformation Characteristics of Geomaterials, IS-Glasgow 2019. - : EDP Sciences. - 2267-1242. - 9782759890644 ; 92
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Konferensbidrag (refereegranskat)abstract
- In this experimental study the influence of fissuring orientation and confinement pressure on the mechanical behaviour of natural clays is investigated. The tested material, the scaly clay from Santa Croce di Magliano (south of Italy), is characterised by an intense network of pre-existing fissures of single orientation. Several plane strain compression tests have been conducted, under different confinement pressures (i.e., from 50 to 600 kPa), on specimens having fissures with vertical, medium and horizontal inclination. Digital Image Correlation has been used to follow the deformation processes of the specimens throughout the tests by measuring incremental shear and volumetric strain maps. The results showed a strong coupling between the total confinement and the fissure inclination, that is controlling both the onset and the development of the patterns of the localisation processes. The new results have been compared with previous ones carried out on the same material without confinement. The comparison shed light on the role of total confinement that becomes particularly relevant from certain levels of pressures and fissuring inclination.
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