Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-24 @ 6:48 PM
NCT ID:
NCT01418157
Eligibility Criteria:
Inclusion Criteria:
* Nepalese national
* Aged 18 to 65
* Travelling directly from Dhunche to Gosainkunda
* Rapid ascent as defined by ascent within 3 days
Exclusion Criteria:
* Use of any drugs for the prevention of altitude sickness or headache
* Current illness
* Current altitude sickness (more than one mild symptom on the Lake Louise Questionnaire (LLQ), or oxygen saturation less than 75%
* Known to be pregnant or cannot exclude the possibility of being pregnant, or have missed menses by over 7 days
* One night within the last 30 days spent at an altitude of 4500 metres or above
* Residents of altitude more than 2500m
* A known drug allergy to sulfonamides.
* Treatment with any of the following in the last 2 days: acetazolamide (Diamox®), steroids (dexamethasone/decadron, prednisone), theophylline or diuretics (Lasix®), ibuprofen/motrin, naprosyn/naproxen, aspirin or acetaminophen.
* Any serious intracranial abnormalities such as history of brain tumours or pseudotumour cerebri
* Known severe uncontrolled headache syndrome
* Diagnosed renal function impairment, diabetes, cirrhosis of liver or liver dysfunction
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01418157
Study Brief:
Protocol Section:
NCT01418157