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To evaluate the additive value of tadalafil given together with Diamox (acetazolamide) in preventing acute mountain sickness in travelers to high altitude areas.
A randomized controlled study comparing:
Tadalafil [20mg x1/day] and acetazolamide [125mg x2 day], versus Acetazolamide [125mg x2 day] alone, in trekkers to altitude > 3,000 m.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetazolamide | Active Comparator | acetazolamide 125 mg BID |
|
| Acetazolamide and Tadalafil | Experimental | Intervention arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil and acetazolamide | Drug | Experimental arm: Tadalafil 20 mg daily + acetazolamide 125 mg BID beginning above 3000 m altitude. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Results will be evaluated by using the Lake Louise AMS scoring system | one month after travel |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center of Geographic Medicine | Tel Litwinsky | Israel | ||||
| Sheba Medical Ctr. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22943271 | Result | Leshem E, Caine Y, Rosenberg E, Maaravi Y, Hermesh H, Schwartz E. Tadalafil and acetazolamide versus acetazolamide for the prevention of severe high-altitude illness. J Travel Med. 2012 Sep-Oct;19(5):308-10. doi: 10.1111/j.1708-8305.2012.00636.x. Epub 2012 Jul 30. |
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| ID | Term |
|---|---|
| D011654 | Pulmonary Edema |
| D001929 | Brain Edema |
| D000532 | Altitude Sickness |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| D000086 | Acetazolamide |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Acetazolamide | Drug | Active comparator arm (control): acetazolamide 125 mg BID beginning above 3000 m altitude |
|
| Tel Litwinsky |
| Israel |
| Tel Litwinsky | Israel |
| D009422 | Nervous System Diseases |
| D012120 | Respiration Disorders |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |