Follow-Up Phase
Polish translation: okres obserwacji kontrolnej po badaniu
| 14:18 Feb 10, 2006 |
| English to Polish translations [PRO] Medical - Medical (general) | |||||
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|  Selected response from: Dominika Schoenborn United Kingdom Local time: 15:34 | ||||
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| 4 +1 | okres obserwacji kontrolnej po badaniu |
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13 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1| follow-up phase okres obserwacji kontrolnej po badaniu Explanation: ja znam takie tlumaczenie -------------------------------------------------- Note added at 17 mins (2006-02-10 14:35:53 GMT) -------------------------------------------------- Purpose This study will: 1) examine whether a new drug called GMA161 is safe when administered to patients with idiopathic thrombocytopenic purpura (ITP); and 2) evaluate how the body handles the drug at different doses. In patients with ITP, platelets (a component of blood needed for clotting) are rapidly destroyed. Patients are at increased risk of bleeding, commonly in the skin (bruising) and mucous membranes (nosebleeds). Bleeding can also occur in the stomach, intestines, kidneys, brain and other organs and lead to serious complications. GMA161 is a monoclonal antibody that may transiently increase platelet counts. Screening Phase Patients 18 years of age and older who have been diagnosed with ITP for at least 6 months may be eligible for this study. Each candidate is screened with a medical history, physical examination, chest x-ray, and blood and urine tests. Drug Administration Phase Participants who qualify for the study would return to NIH to receive an infusion of GMA161 through a small needle-like tube inserted into a vein in the arm. Additional procedures done on the day of this visit will include a brief physical examination and measurement of vital signs (temperature, heart rate, respiratory rate, blood pressure, oxygen levels) as well as blood samples taken a number of times before and after the infusion. This visit takes 12 to 14 hours and is at NIH. Follow-up Phase Participants will return for regular visits for a minimum of 6 weeks. These visits take 1 to 2 hours and may be done at NIH or at home by a nurse and by telephone call from an NIH research nurse. The procedures patients will undergo at these visits may include an update on health status, transfusions record, and medication use since the previous visit; a brief physical examination; measurement of vital signs; and urine and blood sample collection. Patients will also undergo an electrocardiogram once during the follow-up phase. |
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