13 research outputs found

    Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

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    Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

    Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial

    Get PDF
    Dimethyl fumarate (DMF) inhibits inflammasome-mediated inflammation and has been proposed as a treatment for patients hospitalised with COVID-19. This randomised, controlled, open-label platform trial (Randomised Evaluation of COVID-19 Therapy [RECOVERY]), is assessing multiple treatments in patients hospitalised for COVID-19 (NCT04381936, ISRCTN50189673). In this assessment of DMF performed at 27 UK hospitals, adults were randomly allocated (1:1) to either usual standard of care alone or usual standard of care plus DMF. The primary outcome was clinical status on day 5 measured on a seven-point ordinal scale. Secondary outcomes were time to sustained improvement in clinical status, time to discharge, day 5 peripheral blood oxygenation, day 5 C-reactive protein, and improvement in day 10 clinical status. Between 2 March 2021 and 18 November 2021, 713 patients were enroled in the DMF evaluation, of whom 356 were randomly allocated to receive usual care plus DMF, and 357 to usual care alone. 95% of patients received corticosteroids as part of routine care. There was no evidence of a beneficial effect of DMF on clinical status at day 5 (common odds ratio of unfavourable outcome 1.12; 95% CI 0.86-1.47; p = 0.40). There was no significant effect of DMF on any secondary outcome

    Comparison between selected hormone and protein levels in serum and prostate tissue homogenates in men with benign prostatic hyperplasia and metabolic disorders

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    Katarzyna Grzesiak,1 Aleksandra Rył,2 Irena Baranowska-Bosiacka,3 Iwona Rotter,2 Barbara Dołęgowska,4 Marcin Słojewski,5 Olimpia Sipak-Szmigiel,6 Weronika Ratajczak,1 Anna Lubkowska,7 Emilia Metryka,3 Małgorzata Piasecka,1 Maria Laszczyńska1 1Department of Histology and Developmental Biology, Pomeranian Medical University, Szczecin, Poland; 2Department of Medical Rehabilitation and Clinical Physiotherapy, Pomeranian Medical University, Szczecin, Poland; 3Department of Biochemistry and Medical Chemistry, Pomeranian Medical University, Szczecin, Poland; 4Department of Laboratory Medicine, Pomeranian Medical University, Szczecin, Poland; 5Department of Urology and Urological Oncology, Pomeranian Medical University, Szczecin, Poland; 6Department of Obstetrics and Pathology of Pregnancy, Pomeranian Medical University, Szczecin, Poland; 7Department of Functional Diagnostics and Physical Medicine, Pomeranian Medical University, Szczecin, Poland Purpose: The purpose of the study was to assess the relationship between changes in the levels of selected hormones in serum and prostate tissue homogenate in regard to metabolic disorders in patients with diagnosed, surgically treated benign prostatic hyperplasia (BPH). Patients and methods: The study involved a group of 154 men with a diagnosis of BPH with metabolic syndrome (MetS) and without MetS. The serum levels of the hormones – total testosterone, free testosterone, insulin, dehydroepiandrosterone sulfate, estradiol, luteinizing hormone, sex hormone binding globulin (SHBG), and insulin-like growth factor-1 (IGF-1) – were determined using the ELISA method. Prostate tissue sections obtained from the patients during transurethral resection of the prostate were frozen in liquid nitrogen. We determined the levels of the same hormones. Results: There was a statistically significant difference between the groups in terms of serum SHBG levels, but not in the prostate tissue SHBG levels. A similar relationship was observed in regard to IGF-1, the serum levels of which were significantly higher in patients with MetS. MetS had an effect on the ratio of hormone levels in serum to their levels in the prostate tissue. Correlations between the levels of biochemical parameters and the levels of hormones in serum and the prostate tissue of BPH patients with and without MetS demonstrate that serum SHBG levels correlated weakly with waist size and triglyceride levels. Conclusion: The occurrence of MetS in BPH patients was associated with changes in the levels of hormones and proteins. These changes, however, were not always equivalent to changes in the levels of these parameters in prostate tissue. It should also be mentioned that MetS in BPH patients had an influence on a quantitative balance between the levels of SHBG in serum and prostate tissue. Keywords: benign prostatic hyperplasia, hormone levels, metabolic disorder

    Thigh-length compression stockings and DVT after stroke

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    Controversy exists as to whether neoadjuvant chemotherapy improves survival in patients with invasive bladder cancer, despite randomised controlled trials of more than 3000 patients. We undertook a systematic review and meta-analysis to assess the effect of such treatment on survival in patients with this disease

    Core outcome set for surgical trials in gastric cancer (GASTROS study): international patient and healthcare professional consensus

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    Background: Surgery is the primary treatment that can offer potential cure for gastric cancer, but is associated with significant risks. Identifying optimal surgical approaches should be based on comparing outcomes from well designed trials. Currently, trials report different outcomes, making synthesis of evidence difficult. To address this, the aim of this study was to develop a core outcome set (COS)-a standardized group of outcomes important to key international stakeholders-that should be reported by future trials in this field.Methods: Stage 1 of the study involved identifying potentially important outcomes from previous trials and a series of patient interviews. Stage 2 involved patients and healthcare professionals prioritizing outcomes using a multilanguage international Delphi survey that informed an international consensus meeting at which the COS was finalized.Results: Some 498 outcomes were identified from previously reported trials and patient interviews, and rationalized into 56 items presented in the Delphi survey. A total of 952 patients, surgeons, and nurses enrolled in round 1 of the survey, and 662 (70 per cent) completed round 2. Following the consensus meeting, eight outcomes were included in the COS: disease-free survival, disease-specific survival, surgery-related death, recurrence, completeness of tumour removal, overall quality of life, nutritional effects, and 'serious' adverse events.Conclusion: A COS for surgical trials in gastric cancer has been developed with international patients and healthcare professionals. This is a minimum set of outcomes that is recommended to be used in all future trials in this field to improve trial design and synthesis of evidence
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