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- Heggebo, L. C., et al.
(författare)
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Investigating survival, quality of life and cognition in PROton versus photon therapy for IDH-mutated diffuse grade 2 and 3 GLIOmas (PRO-GLIO): a randomised controlled trial in Norway and Sweden
- 2023
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Ingår i: Bmj Open. - : BMJ. - 2044-6055. ; 13:3
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Tidskriftsartikel (refereegranskat)abstract
- IntroductionThe use of proton therapy increases globally despite a lack of randomised controlled trials demonstrating its efficacy and safety. Proton therapy enables sparing of non-neoplastic tissue from radiation. This is principally beneficial and holds promise of reduced long-term side effects. However, the sparing of seemingly non-cancerous tissue is not necessarily positive for isocitrate dehydrogenase (IDH)-mutated diffuse gliomas grade 2-3, which have a diffuse growth pattern. With their relatively good prognosis, yet incurable nature, therapy needs to be delicately balanced to achieve a maximal survival benefit combined with an optimised quality of life.Methods and analysisPRO-GLIO (PROton versus photon therapy in IDH-mutated diffuse grade 2 and 3 GLIOmas) is an open-label, multicentre, randomised phase III non-inferiority study. 224 patients aged 18-65 years with IDH-mutated diffuse gliomas grade 2-3 from Norway and Sweden will be randomised 1:1 to radiotherapy delivered with protons (experimental arm) or photons (standard arm). First intervention-free survival at 2 years is the primary endpoint. Key secondary endpoints are fatigue and cognitive impairment, both at 2 years. Additional secondary outcomes include several survival measures, health-related quality of life parameters and health economy endpoints.Ethics and disseminationTo implement proton therapy as part of standard of care for patients with IDH-mutated diffuse gliomas grade 2-3, it should be deemed safe. With its randomised controlled design testing proton versus photon therapy, PRO-GLIO will provide important information for this patient population concerning safety, cognition, fatigue and other quality of life parameters. As proton therapy is considerably more costly than its photon counterpart, cost-effectiveness will also be evaluated. PRO-GLIO is approved by ethical committees in Norway (Regional Committee for Medical & Health Research Ethics) and Sweden (The Swedish Ethical Review Authority) and patient inclusion has commenced. Trial results will be published in international peer-reviewed journals, relevant conferences, national and international meetings and expert forums.Trial registration numberClinicalTrials.gov Registry (NCT05190172).
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- Sundh, Henrik, 1976, et al.
(författare)
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The effect of hyperoxygenation and reduced flow in fresh water and subsequent infectious pancreatic necrosis virus challenge in sea water, on the intestinal barrier integrity in Atlantic salmon, Salmo salar L
- 2009
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Ingår i: Journal of Fish Diseases. - 1365-2761. ; 32:8, s. 687-98
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Tidskriftsartikel (refereegranskat)abstract
- In high intensive fish production systems, hyperoxygenation and reduced flow are often used to save water and increase the holding capacity. This commonly used husbandry practice has been shown to be stressful to fish and increase mortality after infectious pancreatic necrosis virus (IPNV) challenge, but the cause and effect relationship is not known. Salmonids are particularly sensitive to stress during smoltification and the first weeks after seawater (SW) transfer. This work aimed at investigating the impact of hyperoxygenation combined with reduced flow in fresh water (FW), on the intestinal barrier in FW as well as during later life stages in SW. It further aims at investigating the role of the intestinal barrier during IPNV challenge and possible secondary infections. Hyperoxygenation in FW acted as a stressor as shown by significantly elevated plasma cortisol levels. This stressful husbandry condition tended to increase paracellular permeability (P(app)) as well as translocation of Aeromonas salmonicida in the posterior intestine of Atlantic salmon. After transfer to SW and subsequent IPNV challenge, intestinal permeability, as shown by P(app), and translocation rate of A. salmonicida increased in the anterior intestine, concomitant with further elevation in plasma cortisol levels. In the anterior intestine, four of five fish displayed alterations in intestinal appearance. In two of five fish, IPNV caused massive necrosis with significant loss of cell material and in a further two fish, IPNV caused increased infiltration of lymphocytes into the epithelium and granulocytes in the lamina propria. Hyperoxygenation and reduced flow in the FW stage may serve as stressors with impact mainly during later stages of development. Fish with an early history of hyperoxygenation showed a higher stress response concomitant with a disturbed intestinal barrier function, which may be a cause for the increased susceptibility to IPNV infection and increased susceptibility to secondary infections.
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- Wohlfahrt, J. C., et al.
(författare)
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A novel non-surgical method for mild peri-implantitis- a multicenter consecutive case series
- 2017
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Ingår i: International Journal of Implant Dentistry. - : Springer. - 2198-4034. ; 3:1
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Tidskriftsartikel (refereegranskat)abstract
- AIM:The aim of the present study was to evaluate the effect on peri-implant mucosal inflammation from the use of a novel instrument made of chitosan in the non-surgical treatment of mild peri-implantitis across several clinical centers.MATERIALS AND METHODS:In this 6-month multicenter prospective consecutive case series performed in six different periodontal specialist clinics, 63 implants in 63 patients were finally included. The subjects had mild peri-implantitis defined as radiographic bone loss of 1-2 mm, pocket probing depth (PPD) ≥4 mm and a positive bleeding on probing (mBoP) score. The patients were clinically examined at baseline and after 2, 4, 12 and 24 weeks, and radiographs were taken at baseline and at 3 and 6 months. Treatment of the implants with the chitosan brush seated in an oscillating dental drill piece was performed at baseline and at 3 months. Reductions in the clinical parameters (PPD and mBoP) were compared between baseline and the later examination time points.RESULTS:Significant reductions in both PPD and mBoP were observed at all time points compared with the baseline clinical measurements (p < 0.001). The mean PPD and mBoP at baseline were 5.15 mm (4.97; 5.32) and 1.86 (1.78; 1.93), respectively, whereas the mean PPD and mBoP at 6 months were 4.0 mm (3.91; 4.19) and 0.64 (0.54; 0.75), respectively. Stable reductions in PPD and mBoP were evident up to 6 months after the initial treatment and 3 months after the second treatment. All 63 implants were reported to have stable radiographic levels of osseous support.CONCLUSIONS:This case series demonstrated that an oscillating chitosan brush is safe to use and seems to have merits in the non-surgical treatment of dental implants with mild peri-implantitis. To measure the effectiveness of the method, a multicenter randomized clinical trial needs to be undertaken.
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