| 1. |
- Ruilope, LM, et al.
(författare)
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Design and Baseline Characteristics of the Finerenone in Reducing Cardiovascular Mortality and Morbidity in Diabetic Kidney Disease Trial
- 2019
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Ingår i: American journal of nephrology. - : S. Karger AG. - 1421-9670 .- 0250-8095. ; 50:5, s. 345-356
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Tidskriftsartikel (refereegranskat)abstract
- <b><i>Background:</i></b> Among people with diabetes, those with kidney disease have exceptionally high rates of cardiovascular (CV) morbidity and mortality and progression of their underlying kidney disease. Finerenone is a novel, nonsteroidal, selective mineralocorticoid receptor antagonist that has shown to reduce albuminuria in type 2 diabetes (T2D) patients with chronic kidney disease (CKD) while revealing only a low risk of hyperkalemia. However, the effect of finerenone on CV and renal outcomes has not yet been investigated in long-term trials. <b><i>Patients and</i></b> <b><i>Methods:</i></b> The Finerenone in Reducing CV Mortality and Morbidity in Diabetic Kidney Disease (FIGARO-DKD) trial aims to assess the efficacy and safety of finerenone compared to placebo at reducing clinically important CV and renal outcomes in T2D patients with CKD. FIGARO-DKD is a randomized, double-blind, placebo-controlled, parallel-group, event-driven trial running in 47 countries with an expected duration of approximately 6 years. FIGARO-DKD randomized 7,437 patients with an estimated glomerular filtration rate ≥25 mL/min/1.73 m<sup>2</sup> and albuminuria (urinary albumin-to-creatinine ratio ≥30 to ≤5,000 mg/g). The study has at least 90% power to detect a 20% reduction in the risk of the primary outcome (overall two-sided significance level α = 0.05), the composite of time to first occurrence of CV death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for heart failure. <b><i>Conclusions:</i></b> FIGARO-DKD will determine whether an optimally treated cohort of T2D patients with CKD at high risk of CV and renal events will experience cardiorenal benefits with the addition of finerenone to their treatment regimen. Trial Registration: EudraCT number: 2015-000950-39; ClinicalTrials.gov identifier: NCT02545049.
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| 2. |
- Emery, Carolyn A, et al.
(författare)
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Establishing outcome measures in early knee osteoarthritis
- 2019
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Ingår i: Nature Reviews Rheumatology. - : Springer Science and Business Media LLC. - 1759-4804 .- 1759-4790. ; 15:7, s. 438-448
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Forskningsöversikt (refereegranskat)abstract
- The classification and monitoring of individuals with early knee osteoarthritis (OA) are important considerations for the design and evaluation of therapeutic interventions and require the identification of appropriate outcome measures. Potential outcome domains to assess for early OA include patient-reported outcomes (such as pain, function and quality of life), features of clinical examination (such as joint line tenderness and crepitus), objective measures of physical function, levels of physical activity, features of imaging modalities (such as of magnetic resonance imaging) and biochemical markers in body fluid. Patient characteristics such as adiposity and biomechanics of the knee could also have relevance to the assessment of early OA. Importantly, research is needed to enable the selection of outcome measures that are feasible, reliable and validated in individuals at risk of knee OA or with early knee OA. In this Perspectives article, potential outcome measures for early symptomatic knee OA are discussed, including those measures that could be of use in clinical practice and/or the research setting.
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| 3. |
- Field, M. H., et al.
(författare)
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A palaeoenvironmental reconstruction (based on palaeobotanical data and diatoms) of the Middle Pleistocene elephant (Palaeoloxodon antiquus) butchery site at Marathousa, Megalopolis, Greece
- 2018
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Ingår i: Quaternary International. - : Elsevier BV. - 1040-6182 .- 1873-4553. ; 497, s. 108-122
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Tidskriftsartikel (refereegranskat)abstract
- Exposures of Middle Pleistocene lacustrine sediments at the margins of an open-cast lignite mine at Marathousa near Megalopolis, western Arcadia, Greece yielded the partial remains of a Palaeoloxodon antiquus skeleton which exhibited signs of being butchered. Sedimentation occurred between ca. 400 and 480 ka. Lithic artefacts were found in close spatial and stratigraphic association with the elephant remains. A palaeobotanical investigation (involving carpological, phytolith and wood remains) as well as diatom analysis led to a detailed reconstruction of the local environment at the time of sediment deposition. The results of this study enabled the environmental context of the butchering of the Palaeoloxodon antiquus carcass to be established. Palaeobotanical data show that sediment deposition at the Palaeoloxodon antiquus site occurred in shallow water in front of a reed swamp with trees in the immediate surroundings (particularly Alnus and Salix) on a flat plain where the water table was at or just below the ground surface. Warm conditions prevailed at the time of sediment deposition allowing aquatic plants typically recorded in the climatic optima of European interglacial assemblages to occur (e.g. Brasenia schreberi) and palms (Palmae) to live close-by. This suggests that the organic-rich sediments that contain the archaeological finds represent a transition between the underlying clastic sediments deposited during colder conditions and the overlying lignite that was deposited during warm climatic conditions as reported in previous studies.
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| 4. |
- Hare, Kristoffer B., et al.
(författare)
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Middle-aged patients with an MRI-verified medial meniscal tear report symptoms commonly associated with knee osteoarthritis : A cross-sectional study of 199 patients
- 2017
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Ingår i: Acta Orthopaedica. - : Medical Journals Sweden AB. - 1745-3674 .- 1745-3682. ; 88:6, s. 664-669
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Tidskriftsartikel (refereegranskat)abstract
- Background and purpose — No consensus exists on when to perform arthroscopic partial meniscectomy in patients with a degenerative meniscal tear. Since MRI and clinical tests are not accurate in detecting a symptomatic meniscal lesion, the patient’s symptoms often play a large role when deciding when to perform surgery. We determined the prevalence and severity of self-reported knee symptoms in patients eligible for arthroscopic partial meniscectomy due to a degenerative meniscal tear. We investigated whether symptoms commonly considered to be related to meniscus injury were associated with early radiographic signs of knee osteoarthritis. Patients and methods — We included individual baseline items from the Knee injury and Osteoarthritis Outcome Score collected in 2 randomized controlled trials evaluating treatment for an MRI-verified degenerative medial meniscal tears in 199 patients aged 35–65 years. Each item was scored as no, mild, moderate, severe, extreme, and at least “mild” considering the symptoms present. Early radiographic signs of osteoarthritis, defined as a Kellgren and Lawrence grade of at least 1, were seen in 70 patients. Results — At least monthly knee pain, pain during stair walking and when twisting on the knee, and lack of confidence in knee was present in at least 80% of the patients. Median severity was at least moderate for knee pain, pain when twisting on the knee, pain walking on stairs, lack of confidence in knee, and clicking. Mechanical symptoms such as catching were rare. Early radiographic signs of osteoarthritis were associated with an increased risk of self-reported swelling, catching, and stiffness later in the day; the odds ratio was 2.4 (95% CI 1.2–4.9), 2.3 (1.2–4.3), and 2.3 (1.1–5.0), respectively. Interpretation — Middle-aged patients with a degenerative medial meniscus tear reported symptoms commonly associated with knee osteoarthritis. Frequent knee pain, presence of lack of confidence in the knee, and clicking did not distinguish those with a meniscal tear alone from those with early radiographic knee OA. Our findings support the notion that symptoms reported by those with a degenerative meniscal tear represent early signs of knee osteoarthritis.
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| 5. |
- Kise, Nina Jullum, et al.
(författare)
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Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients : Randomised controlled trial with two year follow-up
- 2016
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Ingår i: British journal of sports medicine. - : BMJ. - 0306-3674 .- 1473-0480. ; 50:23, s. 1473-1480
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Tidskriftsartikel (refereegranskat)abstract
- Objective To determine if exercise therapy is superior to arthroscopic partial meniscectomy for knee function in middle aged patients with degenerative meniscal tears. Design Randomised controlled superiority trial. Setting Orthopaedic departments at two public hospitals and two physiotherapy clinics in Norway. Participants 140 adults, mean age 49.5 years (range 35.7-59.9), with degenerative medial meniscal tear verified by magnetic resonance imaging. 96% had no definitive radiographic evidence of osteoarthritis. Interventions 12 week supervised exercise therapy alone or arthroscopic partial meniscectomy alone. Main outcome measures Intention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS 4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two year follow-up and change in thigh muscle strength from baseline to three months. Results No clinically relevant difference was found between the two groups in change in KOOS 4 at two years (0.9 points, 95% confidence interval4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two year follow-up, with no additional benefit. Conclusion The observed difference in treatment effect was minute after two years of follow-up, and the trial's inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short term. Our results should encourage clinicians and middle aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option. Trial registration www.clinicaltrials.gov (NCT01002794).
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| 6. |
- Kise, Nina Jullum, et al.
(författare)
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Exercise therapy versus arthroscopic partial meniscectomy for degenerative meniscal tear in middle aged patients : Randomised controlled trial with two year follow-up
- 2016
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Ingår i: BMJ (International Edition). - : BMJ. - 0959-8146 .- 1756-1833. ; 354
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To determine if exercise therapy is superior to arthroscopic partial meniscectomy for knee function in middle aged patients with degenerative meniscal tears. Design: Randomised controlled superiority trial. Setting: Orthopaedic departments at two public hospitals and two physiotherapy clinics in Norway. Participants: 140 adults, mean age 49.5 years (range 35.7-59.9), with degenerative medial meniscal tear verified by magnetic resonance imaging. 96% had no definitive radiographic evidence of osteoarthritis. Interventions: 12 week supervised exercise therapy alone or arthroscopic partial meniscectomy alone. Main outcome measures: Intention to treat analysis of between group difference in change in knee injury and osteoarthritis outcome score (KOOS 4), defined a priori as the mean score for four of five KOOS subscale scores (pain, other symptoms, function in sport and recreation, and knee related quality of life) from baseline to two year follow-up and change in thigh muscle strength from baseline to three months. Results: No clinically relevant difference was found between the two groups in change in KOOS 4 at two years (0.9 points, 95% confidence interval â'4.3 to 6.1; P=0.72). At three months, muscle strength had improved in the exercise group (P≤0.004). No serious adverse events occurred in either group during the two year follow-up. 19% of the participants allocated to exercise therapy crossed over to surgery during the two year follow-up, with no additional benefit. Conclusion: The observed difference in treatment effect was minute after two years of follow-up, and the trial's inferential uncertainty was sufficiently small to exclude clinically relevant differences. Exercise therapy showed positive effects over surgery in improving thigh muscle strength, at least in the short term. Our results should encourage clinicians and middle aged patients with degenerative meniscal tear and no definitive radiographic evidence of osteoarthritis to consider supervised exercise therapy as a treatment option.
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| 7. |
- Risberg, May Arna, et al.
(författare)
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Arthroscopic surgical procedures versus sham surgery for patients with femoroacetabular impingement and/or labral tears : Study protocol for a randomized controlled trial (HIPARTI) and a prospective cohort study (HARP)
- 2018
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Ingår i: Journal of Orthopaedic and Sports Physical Therapy. - : Journal of Orthopaedic & Sports Physical Therapy (JOSPT). - 0190-6011 .- 1938-1344. ; 48:4, s. 325-335
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Tidskriftsartikel (refereegranskat)abstract
- STUDY DESIGN: Study protocol for a randomized controlled trial and a prospective cohort. BACKGROUND: The number of arthroscopic surgical procedures for patients with femoroacetabular impingement syndrome (FAIS) has significantly increased worldwide, but high-quality evidence of the effect of such interventions is lacking. OBJECTIVES: The primary objective will be to determine the efficacy of hip arthroscopic procedures compared to sham surgery on patient-reported outcomes for patients with FAIS (HIP ARThroscopy International [HIPARTI] Study). The secondary objective will be to evaluate prognostic factors for long-term outcome after arthroscopic surgical interventions in patients with FAIS (Hip ARthroscopy Prospective [HARP] Study). METHODS: The HIPARTI Study will include 140 patients and the HARP Study will include 100 patients. The international Hip Outcome Tool-33 will be the primary outcome measure at 1 year. Secondary outcome measures will be the Hip disability and Osteoarthritis Outcome Score, Arthritis Self-Efficacy Scale, fear of movement (Tampa Scale of Kinesiophobia), Patient-Specific Functional Scale, global rating of change score, and expectations. Other outcomes will include active hip range of motion, hip muscle strength tests, functional performance tests, as well as radiological assessments using radiographs and magnetic resonance imaging. CONCLUSION: To determine the true effect of surgery, beyond that of placebo, double-blinded placebo-controlled trials including sham surgery are needed. The HIPARTI Study will direct future evidence-based treatment of FAIS. Predictors for long-term development and progression of degenrative changes in the hip are also needed for this young patient group with FAIS; hence, responders and nonresponders to treatment could be determined.
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