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- Karason, Kristjan, 1962, et al.
(författare)
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Randomized trial of a left ventricular assist device as destination therapy versus guideline-directed medical therapy in patients with advanced heart failure. Rationale and design of the SWEdish evaluation of left Ventricular Assist Device (SweVAD) trial
- 2020
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Ingår i: European Journal of Heart Failure. - : Wiley. - 1388-9842 .- 1879-0844. ; 22:2, s. 739-50
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Tidskriftsartikel (refereegranskat)abstract
- Aims Patients with advanced heart failure (AdHF) who are ineligible for heart transplantation (HTx) can become candidates for treatment with a left ventricular assist device (LVAD) in some countries, but not others. This reflects the lack of a systematic analysis of the usefulness of LVAD systems in this context, and of their benefits, limitations and cost-effectiveness. The SWEdish evaluation of left Ventricular Assist Device (SweVAD) study is a Phase IV, prospective, 1:1 randomized, non-blinded, multicentre trial that will examine the impact of assignment to mechanical circulatory support with guideline-directed LVAD destination therapy (GD-LVAD-DT) using the HeartMate 3 (HM3) continuous flow pump vs. guideline-directed medical therapy (GDMT) on survival in a population of AdHF patients ineligible for HTx. Methods A total of 80 patients will be recruited to SweVAD at the seven university hospitals in Sweden. The study population will comprise patients with AdHF (New York Heart Association class IIIB-IV, INTERMACS profile 2-6) who display signs of poor prognosis despite GDMT and who are not considered eligible for HTx. Participants will be followed for 2 years or until death occurs. Other endpoints will be determined by blinded adjudication. Patients who remain on study-assigned interventions beyond 2 years will be asked to continue follow-up for outcomes and adverse events for up to 5 years. Conclusion The SweVAD study will compare survival, medium-term benefits, costs and potential hazards between GD-LVAD-DT and GDMT and will provide a valuable reference point to guide destination therapy strategies for patients with AdHF ineligible for HTx.
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- Killander, F, et al.
(författare)
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No increased cardiac mortality or morbidity of radiotherapy in breast cancer patients after breast conserving surgery: 20 years follow-up of the randomised x trial.
- 2020
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Ingår i: International journal of radiation oncology, biology, physics. - : Elsevier BV. - 1879-355X .- 0360-3016. ; 107:4, s. 701-9
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Tidskriftsartikel (refereegranskat)abstract
- Radiotherapy (RT) after breast conserving surgery reduces loco-regional recurrences and improves survival, but may cause late side effects. The main purpose of this paper was to investigate long-term side effects after whole breast RT in a randomised clinical trial initiated in 1991 and to report dose-volume data based on individual 3D treatment plans for organs at risk (OR).The trial included 1187 T1-2 N0 breast cancer patients randomised to postoperative tangential whole breast radiotherapy or no further treatment. The prescription dose to the clinical target volume was 48-54 Gy. We present 20 year follow-up on survival, cause of death, morbidity and later malignancies. For a cohort of patients (n=157) with accessible CT-based 3D treatment plans in Dicom-RT format, dose-volume descriptors for OR were derived. In addition, these were compared with dose-volume data for a cohort of patients treated with contemporary RT techniques.The cumulative incidence of cardiac mortality was 12.4 % in the control group and 13.0 % in the RT group (P= 0.8). There was an increase in stroke mortality, 3.4 % in the control group versus 6.7 % in the RT group (P=0.018). Incidences of contra lateral breast cancer and lung cancer were similar between groups. The median Dmean (range) heart dose for left-sided treatments was 3.0 Gy (1.1-8.1) and the corresponding value for patients treated in 2017 was 1.5 Gy (0.4-6.0).In this trial serious late side effects of whole breast radiotherapy were limited and less than previously reported in large meta-analyses. We observed no increased cardiac mortality in irradiated patients with doses to the heart were median Dmean 3.0 Gy for left-sided RT. The observed increase in stroke mortality may partly be secondary to cardiac side effects, complications to anticoagulant treatment, or to chance, rather than a direct side effect of tangential whole breast irradiation.
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- Lin, CH, et al.
(författare)
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Human ex vivo spinal cord slice culture as a useful model of neural development, lesion, and allogeneic neural cell therapy
- 2020
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Ingår i: Stem cell research & therapy. - : Springer Science and Business Media LLC. - 1757-6512. ; 11:1, s. 320-
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Tidskriftsartikel (refereegranskat)abstract
- BackgroundThere are multiple promising treatment strategies for central nervous system trauma and disease. However, to develop clinically potent and safe treatments, models of human-specific conditions are needed to complement in vitro and in vivo animal model-based studies.MethodsWe established human brain stem and spinal cord (cross- and longitudinal sections) organotypic cultures (hOCs) from first trimester tissues after informed consent by donor and ethical approval by the Regional Human Ethics Committee, Stockholm (lately referred to as Swedish Ethical Review Authority), and The National Board of Health and Welfare, Sweden. We evaluated the stability of hOCs with a semi-quantitative hOC score, immunohistochemistry, flow cytometry, Ca2+signaling, and electrophysiological analysis. We also applied experimental allogeneic human neural cell therapy after injury in the ex vivo spinal cord slices.ResultsThe spinal cord hOCs presented relatively stable features during 7–21 days in vitro (DIV) (except a slightly increased cell proliferation and activated glial response). After contusion injury performed at 7 DIV, a significant reduction of the hOC score, increase of the activated caspase-3+cell population, and activated microglial populations at 14 days postinjury compared to sham controls were observed. Such elevation in the activated caspase-3+population and activated microglial population was not observed after allogeneic human neural cell therapy.ConclusionsWe conclude that human spinal cord slice cultures have potential for future structural and functional studies of human spinal cord development, injury, and treatment strategies.
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- Adnan, Ali, et al.
(författare)
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Health-related quality of life among tonsillar carcinoma patients in Sweden in relation to treatment and comparison with quality of life among the population
- 2020
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Ingår i: Head and Neck-Journal for the Sciences and Specialties of the Head and Neck. - : Wiley. - 1043-3074 .- 1097-0347. ; 42:5, s. 860-872
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Tidskriftsartikel (refereegranskat)abstract
- Background The health-related quality of life (HRQOL) of tonsillar carcinoma survivors was explored to investigate any HRQOL differences associated with tumor stage and treatment. The survivors' HRQOL was also compared to reference scores from the population. Methods In this exploratory cross-sectional study patients were invited 15 months after their diagnosis and asked to answer two quality of life questionnaires (EORTC QLQ- C30, EORTC QLQ- HN35), 405 participated. Results HRQOL was associated with gender, with males scoring better than females on a few scales. Patients' HRQOL was more associated with treatment than tumor stage. Patients' HRQOL was worse than that in an age- and sex-matched reference group from the normal population, the largest differences were found for problems with dry mouth followed by problems with sticky saliva, senses, swallowing and appetite loss. Conclusions The tonsillar carcinoma patients had a worse HRQOL compared to the general population one year after treatment.
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| 8. |
- Axman, E., et al.
(författare)
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Chronic pain and risk for reoperation for recurrence after inguinal hernia repair using self-gripping mesh
- 2020
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Ingår i: Surgery. - : Elsevier BV. - 0039-6060 .- 1532-7361. ; 167:3, s. 609-613
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Tidskriftsartikel (refereegranskat)abstract
- Background: Improved recurrence rates after groin hernia surgery have led to chronic pain becoming the most troublesome postoperative complication. Self-gripping mesh was developed to decrease the risk for development of chronic pain. The aim of this nationwide cohort study was to compare recurrence rate and chronic pain 1 year after an open, anterior mesh repair of inguinal hernias with either a self-gripping mesh or other lightweight mesh. Method: All operations registered as open anterior mesh repair (Lichtenstein) in the Swedish Hernia Registry between September 2012 and October 2016 were selected. At 1 year after repair, patients were sent a pain questionnaire assessing chronic pain. We compared the prevalence of chronic pain and reoperation for recurrence using lightweight, sutured mesh or self-gripping mesh. Results: We analyzed the 1,803 repairs using self-gripping mesh and 16,567 repairs using lightweight mesh. We found no difference in the prevalence of chronic pain 1 year after the hernia repair between selfgripping mesh and sutured lightweight mesh (OR 0.92, CI 95% 0.80-1.06, P = .257). There was no increase in reoperation for recurrence when using self-gripping mesh (HR 0.71, CI 95% 0.45-1.14, P = .156). Mean operation time was considerably less when using self-gripping mesh (43 vs 70 minutes; P > .001). Conclusion: The use of self-gripping mesh does not decrease the incidence of chronic pain and reoperation for recurrence compared with lightweight, sutured mesh for open anterior mesh repair of inguinal hernias. Furthermore, the use of self-gripping mesh is associated with a clinically important, lesser operation time. (C) 2019 Elsevier Inc. All rights reserved.
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| 9. |
- Bonn, Stephanie E., et al.
(författare)
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Is leisure time sitting associated with mortality rates among men diagnosed with localized prostate cancer?
- 2020
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Ingår i: European Journal of Cancer Prevention. - : Lippincott Williams & Wilkins. - 0959-8278 .- 1473-5709. ; 29:2, s. 134-140
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: Being physically active postdiagnosis has been associated with lower rates of prostate cancer progression and mortality, but studies investigating postdiagnostic time spent sitting are lacking. We aim to study the association between leisure time sitting after a prostate cancer diagnosis and overall and prostate cancer-specific mortality. METHODS: Data from 4595 men in Sweden, diagnosed with localized prostate cancer between 1997-2002 and followed-up until the end of 2012, were analyzed. Time spent sitting during leisure time postdiagnosis was categorized into <2, 2-3, 3-4, and >4 h/day. Multivariable-adjusted Cox proportional hazards models were used to estimate hazard ratios (HRs) with 95% confidence intervals (CI) of postdiagnosis leisure time sitting and a joint variable of sitting time and exercise, and time to overall or prostate cancer-specific death. RESULTS: The results showed no significant associations between postdiagnostic leisure time sitting and overall or prostate cancer-specific mortality rates. When the joint effect of both sitting and exercise time was considered, borderline significantly lower mortality rates for overall and prostate cancer-specific mortality were seen among participants that sat the least and exercised the most compared to the reference category with participants sitting the most and exercising least (HR: 0.75; 95% CI: 0.56-1.00 and HR: 0.61; 95% CI: 0.36-1.05, respectively). CONCLUSIONS: No significant association between leisure time sitting and mortality rates among men diagnosed with localized prostate cancer was seen. This study does not support an association between leisure time sitting per se; however, being physically active may have beneficial effects on survival among men diagnosed with localized prostate cancer.
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| 10. |
- Hellman, K., et al.
(författare)
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Primary treatment and relative survival by stage and age in vulvar squamous cell carcinoma: A population-based SweGCG study
- 2020
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Ingår i: Gynecologic Oncology. - : Elsevier BV. - 0090-8258 .- 1095-6859. ; 159:3, s. 663-671
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Vulvar cancer affects mainly elderly women and with an ageing population the incidence has increased. We explored the primary treatment patterns and relative survival of patients with vulvar squamous cell carcinoma (VSCC) by stage and age-group. Methods: A population-based nationwide study on women diagnosed with VSCC between 2012 and 2016 and registered in the Swedish Quality Registry for Gynecologic Cancer (SQRGC). Main outcome was 5-year relative survival (RS) estimated by the Pohar Perme method. The relative risk of excess mortality (EMRR) between different groups was analyzed by Poisson regression. The age-standardized relative survival (AS-RS) was estimated for the total cohort. Results: Median follow-up time was 41 months. The study population included 657 women; 33% were ≥ 80 years old. FIGO stage I was most common (55%). Primary surgery was performed in 96% stage I, 65% stage II, 80% stage III and 28% stage IV. In women ≥80 years, exploration of the groins and chemoradiotherapy was less often performed. They also received lower mean doses of radiation than younger women. The 5-year AS-RS was 74%. 5-year RS was 84% for stage I, 60% for stage II, 54% for stage III and 35% for stage IV. The EMRR for women ≥80 years compared with women <60 years was 4.3 (p < 0.001); 4.9 (p < 0.001) for stages I-II and 3.5(p = 0.007) for stage III. Conclusions: In general, primary treatment of patients with vulvar squamous cell carcinoma in Sweden adhered to guidelines. Areas of improvement include treatment for stage II and for the very old. © 2020 Elsevier Inc.
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