Please select the eligibility criteria that correspond to the clinical trial below.
Title: Randomized, Controlled Trial of Erythropoietin in the Prevention of Acute Mountain Sickness
Brief Summary: Acute mountain sickness (AMS) is a syndrome of nonspecific symptoms and is therefore subjective. The Lake Louise Consensus Group defined acute mountain sickness as the presence of headache in an unacclimatized person who has recently arrived at an altitude above 2,500 m plus the presence of one or more of the following: gastrointestinal symptoms (anorexia, nausea, or vomiting), insomnia, dizziness, and lassitude or fatigue. An increase in RBC mass is a natural feature of altitude acclimatization. Hypoxia-induced erythropoietin (EPO) secretion begins hours after ascent and stimulates bone marrow production of red blood cells, but this takes weeks to effect an increase in red cell mass . Therefore, it is feasible that EPO therapy weeks before altitude exposure decrease high altitude illness.

In 1996, Young et al in U.S. Army Research Institute of Environmental Medicine (USARIEM) reported that autologous erythrocyte infusion did not ameliorate the decrement in maximal oxygen uptake at 4,300m altitude despite increasing arterial oxygen carrying capacity. On the basis of this report, USARIEM did not recommend use of recombinant EPO for altitude acclimatization.

However, increases in erythrocyte count, hematocrit and hemoglobin associated with EPO therapy have been shown to decrease fatigue and increase work capacity and exercise tolerance. In addition, improvement in CNS function and cognitive ability has been noted with EPO therapy. Subjective benefits include improvement in sleep habits, tolerance to cold; decreased dyspnea, anginal symptoms and tachycardia and improved appetite, all of which are symptoms associated with high altitude illness.

The investigators also reported improved muscle energy metabolism with EPO in dialysis patients, but not with RBC transfusion.

In this study, the investigators will conduct a randomised controlled trial to assess the effect of EPO administration on AMS at an altitude of 4,130 m.


Options:
A: Inclusion Criteria:

* Permanent residence at low (\<500 m) altitude
* Conventional systolic BP (average of two measurements) 140-159 mmHg or conventional diastolic BP 90-99 mmHg in subjects untreated or after 4 weeks of washout
* Mean daytime systolic BP ≥135 and \<150 mmHg and/or mean daytime diastolic BP ≥85 and \<95 mmHg in subjects untreated or after 4 weeks of washout
* Written informed consent to participate in the study

Exclusion Criteria:

* Conventional systolic BP (average of two measurements) ≥150 mmHg and conventional diastolic BP ≥95 mmHg in treated subjects
* Regular use of two or more antihypertensive drugs (with the exception of subjects on two antihypertensive drugs in low doses)
* Treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)
* Contraindications (including a history of adverse reactions) to angiotensin receptor blockers or calcium antagonists
* History of serious mountain sickness
* Subjects who over 3 months preceding inclusion in the study spent considerable (\> 1 week) amount of time at altitudes above 2500 m.
* Cardiovascular diseases other than hypertension (coronary heart disease, heart failure, atrial fibrillation, valvular or congenital heart disease, cardiomyopathies, cerebrovascular disease, peripheral artery disease, aortic aneurysm)
* Suspected or confirmed secondary hypertension
* Diabetes mellitus
* Serious respiratory disorders
* Other conditions deemed relevant by the investigator (including liver disease, renal disease, thyroid disorders)
* BMI ≥35 kg/m2
* Upper arm circumference \>32 cm
* known severe obstructive sleep apnea (apnea-hypopnea index \> 30 or use of CPAP) or excessive daytime sleepiness (Epworth Sleepiness Scale \> 10)
* Pregnancy
* Premenopausal women not using effective contraceptive methods
* Elevated probability of noncompliance with the study procedures
B: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* History of serious illness
* Current smoker or Hemoglobin \>15.5gm/dL
* Uncontrolled hypertension
C: Inclusion Criteria:

1. Age 18-65 healthy non-pregnant volunteer
2. Sea-level dwelling (live at low elevation \< 4000 ft)
3. Arrange your own transportation to WMRS (Bishop) by Friday evening of study weekend
4. Available for full study duration (Friday PM-Sunday AM)

Exclusion Criteria:

1. Age \<18 or \>65, Pregnant, Live at altitude \>4000 ft
2. Slept at altitude \> 4000ft within 1 week of study
3. Allergic to acetazolamide, sulfa drugs, or non-steroidal anti-inflammatories
4. Taking NSAIDs, Acetazolamide, or Corticosteroids 1 week prior to study
5. Medical History of Brain Tumor, increased brain pressure, pseudotumor cerebri, VP shunts, HACE, or HAPE.
D: Inclusion Criteria:

* Member of the Italian High Altitude Research Expeditions

Exclusion Criteria:

* Are under the age of 18years;
* sulfonamide allergy
* Liver or kidney disfunction
* Have any other uncontrolled medical condition
* Or are unable to give consent.

Answer: B