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This randomised, double-blind study will compare an oral immunomodulatory solution to a placebo for the prevention of acute severe mucositis in head and neck cancer patients treated surgically and concomitantly with radiochemotherapy. The investigators expect a decrease of 25% of severe acute mucositis in experimental arm.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Severe Acute Mucositis
Oral Impact, Placebo
Centre Val d'Aurelle-Paul Lamarque
Centre Val d'Aurelle - Paul Lamarque
Published on BioPortfolio: 2014-08-27T03:12:42-0400
Oral mucositis refers to ulcerative lesions of the oral mucosa that occur due to radiation therapy given for treatment of head and neck cancer. These lesions are painful, compromise nutrit...
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Oral mucositis is one of the most prevalent side effects in patients undergoing radiotherapy for head and neck cancers. Current therapeutic agents such as palifermin (rhKGF) and amifostine do not effi...
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A clinical syndrome with acute abdominal pain that is severe, localized, and rapid onset. Acute abdomen may be caused by a variety of disorders, injuries, or diseases.
Acute form of MALNUTRITION which usually affects children, characterized by a very low weight for height (below -3z scores of the median World Health Organization standards), visible severe wasting, or occurrence of nutritional EDEMA. It can be a direct or indirect cause of fatality in children suffering from DIARRHEA and PNEUMONIA. Do not confuse with starvation, a condition in which the body is not getting enough food, usually for extended periods of time.
Conditions in which the function of KIDNEYS deteriorates suddenly in a matter of days or even hours. It is characterized by the sudden drop in GLOMERULAR FILTRATION RATE; (GMR). The most severe stage is when the GFR drops below 15 ml per min (ACUTE KIDNEY FAILURE).
A severe stage of acute renal insufficiency, characterized by the sudden decrease in GLOMERULAR FILTRATION RATE to less than 15 ml per min, sometime to less than 1 to 2 ml per min. It is usually associated with OLIGURIA; EDEMA; and increase in BLOOD UREA NITROGEN and serum CREATININE concentrations.
Abrupt reduction in kidney function defined as an absolute increase in serum CREATININE of more than or equal to 0.3. mg/dl, a percentage increase in serum creatinine of more than or equal to 50%, or a reduction in urine output. Acute kidney injury encompasses the entire spectrum of the syndrome including acute kidney failure; ACUTE KIDNEY TUBULAR NECROSIS; and other less severe conditions.
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