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The intensity of an adverse event will be rated as follows: mild (Awareness of signs or symptoms, no disruption of usual activity) moderate (Event sufficient to affect usual activity (disturbing)) severe (inability to perform usual activities (unacceptable)) An adverse event is related to the study drug if the investigator judges it causally related.
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mild-awareness of event but easily tolerated, moderate-discomfort enough to cause some interference with usual activity, severe-inability to carry out usual activity.
This should be assessed and described using the following categories: mild-awareness of event but easily tolerated, moderate-discomfort enough to cause some interference with usual activity, severe-inability to carry out usual activity.
[ 10] Exclusion criteria were contra-indication to physical exercise (e.g. unstable or under-investigated coronary heart disease, disseminated cancer, severe osteoporosis), inability to join in a yoga class (e.g. a relevant mental illness), or inability to understand English sufficiently to participate in the class (major cognitive deficit, poor English fluency).
Exclusion criteria included diabetes, cardiovascular disease, current severe illness, inability to speak adequate English or understand the consent form.
Exclusion criteria were the presence of severe psychopathology, inability to communicate in writing, pregnancy or having been proposed for bariatric surgery.
Hospital referrals were defined as those made to the local tertiary facility (UTH), with severe symptoms (inability to drink or breastfeed, severe vomiting, convulsions, respiratory distress, loss of consciousness, or severe lethargy), for surgery, or with an illness requiring consultation with a specialist.
Exclusion criteria were major psychological problems, allergies to any of the ingredients of the injection, renal insufficiency, abnormal liver enzymes, a history of stroke or a major neurological deficit, uncontrolled angina, chronic opioid use, severe diabetes, inability to understand or use patient controlled analgesia (PCA), or any contraindications for spinal anesthesia.
28 Exclusion criteria were relatively few: no prednisone therapy; prednisone dose >5 mg/day; improving or worsening clinical status; anticipation of joint replacement or other elective surgery; uncontrolled hypertension, diabetes or other comorbidities; severe fibromyalgia; inability to complete English language questionnaires; and pregnancy or nursing.
Mild adverse events were defined as "awareness of signs and symptoms, easily tolerated and require no interventions", moderate as "discomfort sufficient enough to interfere with normal activities and/or result in some sort of intervention" and severe as " inability to perform normal activities, distressing and/or incapacitating and definitely require intervention and/or medical attention".
Outcome at discharge was assessed by the modified Rankin scale, a poor outcome was defined by either death or Rankin score of 4 5 which means severe disability and inability to walk without assistance Outcome was defined as good or poor based on the absence or presence of Rankin score of 4 5 and/death.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com