17 research outputs found
Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
- Author
- Abbas M.
- Abdul Rasheed A.
- Abdul A.
- Abdul-Kadir R.
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- Publication venue
- Springer Science and Business Media LLC
- Publication date
- 31/01/2024
- Field of study
Get PDFDimethyl 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
Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial
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- Publication venue
- 'Elsevier BV'
- Publication date
- 01/01/2019
- Field of study
Get PDFBackground
Results of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.
Methods
FOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762.
Findings
Between Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months.
Interpretation
Fluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.
Funding
UK Stroke Association and NIHR Health Technology Assessment Programme
Dimethyl fumarate in patients admitted to hospital with COVID-19 (RECOVERY): a randomised, controlled, open-label, platform trial
- Author
- Abbas M.
- Abdul Rasheed A.
- Abdul A.
- Abdul-Kadir R.
- Abdusamad K.
- Abernethy K.
- Aboelela H.
- Abouzaid M.
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- Byrne J.
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- Cale E.
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- Caws C.
- Central Coordinating Office (for the RECOVERY Collaborative Group)
- Century H.
- Chadwick J.
- Chakkarapani E.
- Chakraborty A.
- Chamberlain S.
- Chambers E.
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- Chan E.
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- Charles B.
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- Chatterton D.
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- Chauhan R.
- Chawla V.
- Chen F.
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- Cherrie M.
- Cheung E.
- Cheyne C.
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- Chilvers A.
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- Chineka R.
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- Chisnall B.
- Chiswick C.
- Chivima B.
- Chmiel C.
- Chrisopoulou A.
- Christian P.
- Christides A.
- Christmas D.
- Church E.
- Cianci N.
- Cicconi P.
- Clare E.
- Clark E.
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- Clayton-Smith J.
- Cleaver C.
- Clemente de la Torre C.
- Clifford S.
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- Cocks S.
- Coe A.
- Coey D.
- Cohen D.
- Coker O.
- Cole J.
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- Collier D.
- Collini Paul
- Collins J.
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- Colton H.
- Condliffe R.
- Connell E.
- Connell L.
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- Connolly G.
- Connor E.
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- Conteh V.
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- Cooke G.
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- Corbett C.
- Corbishley A.
- Cornwell J.
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- Cotterill D.
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- Darbyshire Janet
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- Data Monitoring Committee of the RECOVERY Collaborative Group
- Daunt A.
- Dave V.
- Davey M.
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- De Soyza A.
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- Dear J.
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- Desai A.
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- Dhani S.
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- Dimitri P.
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- Dobbie L.
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- Dolan D.
- Dolman M.
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- Donohoe A.
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- Duffy H.
- Duggan A.
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- Dunn A.
- Duran B.
- Durrans L.
- Durrington H.
- Duru I.
- Dymond H.
- D’Costa J.
- D’Mello A.
- Eades C.
- Early J.
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- Elgohary A.
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- Essa F.
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- Everden C.
- Everden S.
- Evison L.
- Ezenduka C.
- Fairbairn I.
- Fairclough A.
- Falconer E.
- Faluyi D.
- Fancois V.
- Farmery T.
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- Farrell B.
- Farzana S.
- Fatemi A.
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- Faust Saul N.
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- Fenton C.
- Ferenando G.
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- Health records (for the RECOVERY Collaborative Group)
- Hector G.
- Heddon S.
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- Jones A.
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- Local Clinical Centre staff (for the RECOVERY Collaborative Group)
- Lock S.
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- Logue C. A.
- Lokanathan S.
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Get PDFDimethyl 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
Issues in the evaluation of alcoholism treatment.
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No full textAlcoholism and social isolation.
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No full textPROBLEMS OF LANGUAGE IN CROSS-CULTURAL RESEARCH
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No full textSpousal Violence and Alcohol/Drug Problems Among Parolees and Their Spouses
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No full text
The Preoccupation with Alcohol Scale: Development and Validation
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No full textThigh-length compression stockings and DVT after stroke
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- Publication venue
- 'Elsevier BV'
- Publication date
- 01/07/1994
- Field of study
Get PDFControversy 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
