The American journal of medicine
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Randomized Controlled Trial Clinical Trial
The randomized controlled clinical trial. Scientific and ethical bases.
Randomized controlled trials are increasingly accepted in principle but not always in practice, particularly for surgical therapies. Successful surgical randomized controlled trials demonstrate their feasibility, and reports of uncontrolled surgical trials now commonly bear a statement that a definitive answer requires a controlled trial. ⋯ With candor in informed consent, the equal chance not to get a trial treatment makes the randomized controlled trial the most ethical design. Thus, scientific, behavioral, and ethical cases support the randomized controlled trial as the optimal method for investigation of nearly all therapeutic innovations and as a requirement for publication.
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Prompted by studies that suggested a causal relationship between sex steroids and human liver cancer, we assayed specimens of hepatoma from five patients and adjacent liver tissue from three of the same patients for estrogen receptors. After finding that the assay material contained specific cytosolic receptor proteins for estradiol, we treated a second group of five patients who had hepatomas with progestin. This therapy resulted in tumor regression in two of these patients.
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While receiving estrogen therapy, three women with classic type I von Willebrand's disease showed significantly less bleeding and improved hemostasis. One took estrogens to prevent menopausal symptoms, and two used oral contraceptives. ⋯ Furthermore, two other women with type I von Willebrand's disease also exhibited improved hemostasis while taking oral contraceptives. These experiences suggest a short course of estrogen therapy may effectively prepare some women with von Willebrand's disease for elective surgery.
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Hypernatremia in elderly patients is most often due to the patients mental incapacity or physical inability to obtain water despite intact thirst sensation. Hypodipsia leading to hypernatremia is not often considered in alert, elderly subjects since hypodipsia is not a recognized consequence of nonaphasia-producing cerebrovascular accidents. ⋯ Hypernatremia in this group was due to hypodipsia and could only be prevented by prescribing daily fluid intake as a medication order. Hypodipsia should be considered as a cause of hypernatremia in elderly subjects even when they seem fully capable of requesting and obtaining water.