| 1. |
- Buunen, M, et al.
(författare)
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COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer.
- 2009
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Ingår i: Danish medical bulletin. - 1603-9629 .- 0907-8916. ; 56:2, s. 89-91
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Tidskriftsartikel (refereegranskat)abstract
- INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal in both treatment groups. Most tumors are located in the mid-rectum (41%). CONCLUSION: Laparoscopic surgery in the treatment of rectal cancer is feasible. The results and safety of laparoscopic surgery in the treatment of rectal cancer remain unknown, but are subject of interim analysis within the COLOR II trial. Completion of inclusion is expected by the end of 2009. Trial registration: Clinicaltrials.gov, identifier: NCT00297791 (www.clinicaltrials.gov).
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| 2. |
- Jonsson, A, et al.
(författare)
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Geriatric rehabilitation as an integral part of geriatric medicine in the Nordic countries
- 2003
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Ingår i: Danish Medical Bulletin. - 0907-8916. ; 50:4, s. 439-445
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: First, to outline the theoretical and practical framework for geriatric rehabilitation in the Nordic countries and second, to survey the scientific medical publications for evidence-based geriatric rehabilitation. Methods: Brainstorming on geriatric rehabilitation in a working group of Nordic teachers in geriatric medicine. Papers on scientific programmes for geriatric rehabilitation from Internet sources were collected and analyzed. All articles describing randomized studies in geriatric rehabilitation were selected for meta-analyses. The papers were divided into four groups according to diseases, infirmity and resource settings: stroke, hip-fractures, acute admissions and programmes conducted in nursing homes, day hospitals and home services. Results: The literature survey included 30 scientific studies (9496 patients) in randomized trials with valid endpoints. Geriatric rehabilitation programmes for stroke patients in geriatric settings (six papers, 1138 patients) reduced mortality and the need for nursing home placement, but the outcome for ADL function was not significantly changed. Function and length of stay varied between the studies. The outcome of geriatric rehabilitation was even more decisive in the randomized hip-fracture studies (seven articles, 2414 patients): the readmission rate and cost were significantly better. Ten studies were found, comparing the outcome of acute admissions of frail elderly patients (4683) with either geriatric (GEMU, GRU) or general medical wards. The effect of rehabilitation regarding mortality rate at one year, placement in a nursing home, physical function, contentment with services, readmission rate and cost was significant improvement in the geriatric settings. Internal comparisons of geriatric programmes in nursing homes, day hospitals and in-home services (seven studies, 1261 patient) revealed some differences in outcomes regarding function, contentment and costs. Conclusion: Specialized geriatric rehabilitation is complicated but effective when properly performed. Interdisciplinary teamwork, targeting of patients, comprehensive assessment and intensive and patient-targeted rehabilitation seem to characterize the most effective programmes. Rehabilitation of frail elderly people poses a major future challenge and has to be developed further for the sake of elderly people's quality of life as well as economic reasons.
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| 3. |
- Riehmann, Morten
(författare)
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Regulatory measures for implementing new medical devices. Recalling Boneloc (R)
- 2005
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Ingår i: Danish Medical Bulletin. - 0907-8916. ; 52:1, s. 11-17
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Tidskriftsartikel (refereegranskat)abstract
- Through the past decades, new medical devices have been introduced at an increasing pace at the urge primarily of manufacturers, clinicians, and patients. Whereas it is mandatory to assess and approve new pharmaceuticals before their widespread use is allowed, innovations in medical devices generally have not been subject to the smae restrictions. The European Communitys program on completion of the Internal Market has generated a series of three Directives regulating the safety, reliability, and marketing of practically all non-pharmaceutical medical products. Once CE-marked, devices are available throughout the Union, an area constitued of nearly half a billion citizens after the expansion to 25 Member States. Before the European Union Directives were implemented, Bonelec (R) was introduced to commercial distribution in the beginning of the nineties as a new and promising bone cement to be utilized in joint arthroplasty prostheses. While promptly gaining wide acceptance in most of the Nordic countries, Bonelec (R) was after few years about 5,500 implanted Scandinavian patients withdrawn from the market abruptly because of inferior fixation properties. Utilizing Boneloc (R) as a test case, the present study critically examined whether a comparable incident could occur after the implementation of the European Union Directives and what strategies can be applied to avoid equivalent future misconduct.
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| 4. |
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| 5. |
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| 6. |
- Sørensen, Ole E
(författare)
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The human cathelicidin hCAP-18
- 2005
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Ingår i: Danish Medical Bulletin. - 0907-8916. ; 52:1, s. 41284-41284
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Tidskriftsartikel (refereegranskat)
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