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Transcranial Laser ...
Transcranial Laser Therapy in Acute Stroke Treatment Results of Neurothera Effectiveness and Safety Trial 3, a Phase III Clinical End Point Device Trial
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Hacke, W. (författare)
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Schellinger, P. D. (författare)
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Albers, G. W. (författare)
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Bornstein, N. M. (författare)
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- Dahlöf, Björn, 1953 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för medicin,Institute of Medicine
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Fulton, R. (författare)
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Kasner, S. E. (författare)
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Shuaib, A. (författare)
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Richieri, S. P. (författare)
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Dilly, S. G. (författare)
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Zivin, J. (författare)
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Lees, K. R. (författare)
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(creator_code:org_t)
- Ovid Technologies (Wolters Kluwer Health), 2014
- 2014
- Engelska.
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Ingår i: Stroke. - : Ovid Technologies (Wolters Kluwer Health). - 0039-2499 .- 1524-4628. ; 45:11, s. 3187-3193
- Relaterad länk:
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https://www.ahajourn...
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- Background and Purpose On the basis of phase II trials, we considered that transcranial laser therapy could have neuroprotective effects in patients with acute ischemic stroke. Methods We studied transcranial laser therapy in a double-blind, sham-controlled randomized clinical trial intended to enroll 1000 patients with acute ischemic stroke treated 24 hours after stroke onset and who did not undergo thrombolytic therapy. The primary efficacy measure was the 90-day functional outcome as assessed by the modified Rankin Scale, with hierarchical Bayesian analysis incorporating relevant previous data. Interim analyses were planned after 300 and 600 patients included. Results The study was terminated on recommendation by the Data Monitoring Committee after a futility analysis of 566 completed patients found no difference in the primary end point (transcranial laser therapy 140/282 [49.6%] versus sham 140/284 [49.3%] for good functional outcome; modified Rankin Scale, 0-2). The results remained stable after inclusion of all 630 randomized patients (adjusted odds ratio, 1.024; 95% confidence interval, 0.705-1.488). Conclusions Once the results of the interim futility analysis became available, all study support was immediately withdrawn by the capital firms behind PhotoThera, and the company was dissolved. Proper termination of the trial was difficult but was finally achieved through special efforts by former employees of PhotoThera, the CRO Parexel and members of the steering and the safety committees. We conclude that transcranial laser therapy does not have a measurable neuroprotective effect in patients with acute ischemic stroke when applied within 24 hours after stroke onset. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT01120301.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Neurologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Neurology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Kardiologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cardiac and Cardiovascular Systems (hsv//eng)
Nyckelord
- acute ischemic stroke
- clinical trials
- phase III
- transcranial laser therapy
- ACUTE ISCHEMIC-STROKE
- NEUROLOGICAL DEFICITS
- NEUROPROTECTION
- NEST-1
- TRENDS
- RATS
- Clinical Neurology
- Peripheral Vascular Disease
Publikations- och innehållstyp
- ref (ämneskategori)
- art (ämneskategori)
Hitta via bibliotek
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Stroke
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Till lärosätets databas
- Av författaren/redakt...
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Hacke, W.
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Schellinger, P. ...
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Albers, G. W.
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Bornstein, N. M.
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Dahlöf, Björn, 1 ...
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Fulton, R.
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visa fler...
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Kasner, S. E.
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Shuaib, A.
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Richieri, S. P.
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Dilly, S. G.
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Zivin, J.
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Lees, K. R.
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visa färre...
- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Neurologi
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Kardiologi
- Artiklar i publikationen
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Stroke
- Av lärosätet
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Göteborgs universitet