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Modest therapeutic performance of FDA-approved nanomedicines combined with multiple disappointing clinical trials (such as phase III HEAT trial) have raised questions about the future of nanomedicine.
Potential reasons for failure of the HEAT trial have been summarized in this review and include issues with clinical trial design, lack of supporting preclinical data, and improvements in the control arm (i.e. RFA alone).
The initial Phase III clinical trial on ThermoDox® (i.e. HEAT trial) evaluating the combination of ThermoDox® and radiofrequency ablation (RFA) in comparison to RFA alone for treatment of inoperable hepatocellular carcinoma (HCC) failed to reach its primary endpoint in progression-free survival (PFS).
HEAT trial in aspirin users (ClinicalTrials.gov Identifier: NCT01506986) is scheduled to start soon.
The primary aim of the HEAT trial is to investigate the hypothesis that H. pylori eradication will reduce the incidence of ulcer bleeding in patients taking aspirin.
The HEAT trial will provide level 1 evidence on the safety and efficacy of using paracetamol to treat elevated body temperature in ICU patients with infections and will help us understand more clearly whether it's hot to be cool or cool to be hot.
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Trial boundaries are rationalised to four values of seasonal performance providing the opportunity to reassess the UK EST heat pump trial results and identify two boundary conditions directly relevant to the interpretation of the Renewable Energy Sources Directive.
Don't you think Mr. Obama would have gladly taken some heat from trial lawyers in exchange for passing health reform with bipartisan support and making himself look like a transformational leader?
The number of survivors from each heat shock trial was taken to be the successes in the model.
Initial sample processing, the heat inactivation trial and supervision of tissue culture of cattle lymph nodes was performed at VLA Weybridge by DRW.
In the HEAT PPCI trial, designed to minimize differential GpIIb/IIIa inhibitor use, bivalirudin was compared against unfractionated heparin, both with bailout GpIIb/IIIa inhibitor.
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CEO of Professional Science Editing for Scientists @ prosciediting.com