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3) Clinical trial assessments should have the primary endpoint of the degree of pain relief or reduction in headache days.
Clinical trial assessments should have the primary endpoint of the degree of pain relief or reduction in headache days.
However, clinical trial assessments should not be limited to the degree of pain relief or headache days because this alone may not be necessary for a clinically meaningful improvement, but should include tolerability, reductions in headache-related disability, improvement in pain-specific quality of life, total costs and improvement in functional capacity.
Design Three arm, randomised parallel trial; assessments at baseline and after six and 12 months.
Based on this analysis all subsequent Palliative Care Trial assessments would include only the most reliable of these 3 measures.
Patients will not be allowed any concomitant antipsychotic medication before all trial assessments at week 12 have been conducted.
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Traditionally a non-spatial or field trial assessment is used.
Fig. 1 Rater proforma for student volunteers' trial assessment of a Healthy Choices Programme session Fig. 2 Teaching needs-supportive rater proforma used in student volunteer training.
The International Headache Society has published guidelines for clinical trial assessment of prophylactic treatment for CM, including guidelines on the selection of outcome measures [11].
Final endpoints were compliance, loco-regional control, survival (after complete 5-year follow-up), and a concept of trial assessment using the treatment-dependent prognostic index TPI.
Methodological quality of studies was generally poor with only 11 studies rated as adequate using the Clinical Trial Assessment Measure (CTAM).
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