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In case of recurrent disease, unacceptable toxicity, or withdrawal of consent, treatment will be terminated.
In case of progression, severe adverse event or withdrawal of consent, treatment was stopped.
Novartis agreed to supply MEK162 on compassionate use base, and after screening for eligibility and parental consent treatment with MEK162 45 mg BID was started.
Published research has explored aspects of trial participation, including recruitment, lay understandings of randomisation, informed consent, treatment compliance and retention to the trial [ 7- 11].
The reason for withdrawal could be a withdrawal of consent, treatment failure, adverse event(s), pregnancy discovered during the trial, significant worsening (Clinical Global Impressions-Improvement (CGI-I) score of 6 or 7 (much or very much worse), change in the dosing of olanzapine or clozapine of more than 20%, or loss to follow-up.
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It was carried out among consenting treatment naïve HIV positive male and female patients aged 18 years and above attending Hoima Regional Referral hospital HIV clinic.
Methods for assessment of decision-making capacity have been developed for different purposes, like the MacArthur Competence Assessment Tool-Treatment for consent to treatment [ 13].
Written informed consent for treatment was obtained from each patient prior to treatment initiation.
Consent to treatment will be gained from each treating physiotherapist prior to commencing treatment, as is current physiotherapy practice.
Treatment was continued until disease progression, unacceptable toxicity, patient withdrawal of consent, or treatment delay of more than 3 weeks.
The discussion on children's competence to consent to treatment and clinical research has made little advancement the last decade.
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CEO of Professional Science Editing for Scientists @ prosciediting.com