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- Goldhahn, Jörg, et al.
(författare)
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Clinical evaluation of medicinal products for acceleration of fracture healing in patients with osteoporosis
- 2008
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Ingår i: Bone. - : Elsevier BV. - 8756-3282 .- 1873-2763. ; 43:2, s. 343-347
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Tidskriftsartikel (refereegranskat)abstract
- Pre-clinical studies indicate that pharmacologic agents can augment fracture union. If these pharmacologic approaches could be translated into clinical benefit and offered to patients with osteoporosis or patients with other risks for impaired fracture union (e.g. in subjects with large defects or open fractures with high complication rate), they could provide an important adjunct to the treatment of fractures. However, widely accepted guidelines are important to encourage the conduct of studies to evaluate bioactive substances, drugs, and new agents that may promote fracture union and subsequent return to normal function. A consensus process was initiated to provide recommendations for the clinical evaluation of potential therapies to augment fracture repair in patients with meta- and diaphyseal fractures. Based on the characteristics of fracture healing and fixation, the following study objectives of a clinical study may be appropriate: a) acceleration of fracture union, b) acceleration of return to normal function and c) reduction of fracture healing complications. The intended goal(s) should determine subsequent study methodology. While an acceleration of return to normal function or a reduction of fracture healing complications in and of themselves may be sufficient primary study endpoints for a phase 3 pivotal study, acceleration of fracture union alone is not. Radiographic evaluation may either occur at multiple time points during the healing process with the aim of measuring the time taken to reach a defined status (e.g. cortical bridging of three cortices or disappearance of fracture lines), or could be obtained at a single pre-determined timepoint, were patients are expected to reach a common clinical milestone (i.e. pain free full weight-bearing in weight-bearing fracture cases). Validated Patient Reported Outcomes (PRO's) measures will need to support the return to normal function co-primary endpoints. If reduction of complication rate (e.g. non-union) is the primary objective, the anticipated complications must be defined in the study protocol, along with their possible associations with the specified fracture type and fixation device. The study design should be randomized, parallel, double-blind, and placebo-controlled, and all fracture subjects should receive a standardized method of fracture fixation, defined as Standard of Care. © 2008 Elsevier Inc. All rights reserved.
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| 2. |
- Hilty, Lorenz M., et al.
(författare)
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Modeling and evaluating the sustainability of smart solutions
- 2014
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Ingår i: Environmental Modelling & Software. - : Elsevier BV. - 1364-8152 .- 1873-6726. ; 56, s. 1-5
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Tidskriftsartikel (refereegranskat)abstract
- Smart technologies provide diverse and promising opportunities to reduce energy demand and greenhouse gas emissions; they are increasingly expected to shift modern societies' patterns of production and consumption towards sustainability. However, the existence of a theoretical potential does not imply that every smart solution (application of a smart technology) will contribute to sustainability. Policy-makers are therefore in need of methodologies to evaluate the sustainability of smart solutions. This paper gives an overview of the current discussion in the field and the emerging methodological challenges. The challenges of assessing the direct impact of the ICT components and infrastructures are special cases of known issues in life cycle assessment methodology. The challenges of assessing indirect impacts are inherently interdisciplinary and call for integrated modelling approaches. The last two sections provide an overview of the papers assembled in this thematic issue that treat specific cases and general principles of modeling and evaluating the sustainability of smart solutions.
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| 3. |
- Olsson, Gustaf, et al.
(författare)
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Research needs in water modelling
- 2008
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Ingår i: Proceedings of the iEMSs Fourth Biennial Meeting: International Congress on Environmental Modelling and Software (iEMSs 2008). - 9788476530740 ; , s. 12-15
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Konferensbidrag (refereegranskat)
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| 4. |
- Rizzoli, René, et al.
(författare)
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Osteonecrosis of the jaw and bisphosphonate treatment for osteoporosis.
- 2008
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Ingår i: Bone. - : Elsevier BV. - 8756-3282. ; 42:5, s. 841-7
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Tidskriftsartikel (refereegranskat)abstract
- A potential side effect associated with bisphosphonates, a class of drugs used in the treatment of osteoporosis, Paget's disease and metastatic bone disease, is osteonecrosis of the jaw (ONJ). The incidence of ONJ in the general population is unknown; this rare condition also may occur in patients not receiving bisphosphonates. Case reports have discussed ONJ development in patients with multiple myeloma or metastatic breast cancer receiving bisphosphonates as palliation for bone metastases. These patients are also receiving chemotherapeutic agents that might impair the immune system and affect angiogenesis. The incidence or prevalence of ONJ in patients taking bisphosphonates for osteoporosis seems to be very rare. No causative relationship has been unequivocally demonstrated between ONJ and bisphosphonate therapy. A majority of ONJ occurs after tooth extraction. Furthermore, the underlying risk of developing ONJ may be increased in osteoporotic patients by comorbid diseases. Treatment for ONJ is generally conservative.
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| 6. |
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| 7. |
- van Ittersum, Martin, et al.
(författare)
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Integrated Assessment of Agricultural and Environmental Policies – A Modular Framework for the EU (SEAMLESS)
- 2008
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Ingår i: Agricultural Systems. - : Elsevier BV. - 0308-521X. ; 96:1-3, s. 150-165
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Tidskriftsartikel (refereegranskat)abstract
- Abstract in UndeterminedAgricultural systems continuously evolve and are forced to change as a result of a range of global and local driving forces. Agricultural technologies and agricultural, environmental and rural development policies are increasingly designed to contribute to the sustainability of agricultural systems and to enhance contributions of agricultural systems to sustainable development at large. The effectiveness and efficiency of such policies and technological developments in realizing desired contributions could be greatly enhanced if the quality of their ex-ante assessments were improved. Four key challenges and requirements to make research tools more useful for integrated assessment in the European Union were defined in interactions between scientists and the European Commission (EC), i.e., overcoming the gap between micro-macro level analysis, the bias in integrated assessments towards either economic or environmental issues, the poor re-use of models and hindrances in technical linkage of models. Tools for integrated assessment must have multi-scale capabilities and preferably be generic and flexible such that they can deal with a broad variety of policy questions. At the same time, to be useful for scientists, the framework must facilitate state-of-the-art science both on aspects of the agricultural systems and on integration. This paper presents the rationale, design and illustration of a component-based framework for agricultural systems (SEAMLESS Integrated Framework) to assess, ex-ante, agricultural and agri-environmental policies and technologies across a range of scales, from field-farm to region and European Union, as well as some global interactions. We have opted for a framework to link individual model and data components and a software infrastructure that allows a flexible (re-)use and linkage of components. The paper outlines the software infrastructure, indicators and model and data components. The illustrative example assesses effects of a trade liberalisation proposal on EU's agriculture and indicates how SEAMLESS addresses the four identified challenges for integrated assessment tools, i.e., linking micro and macro analysis, assessing economic, environmental, social and institutional indicators, (re-)using standalone model components for field, farm and market analysis and their conceptual and technical linkage.
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