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An Assessment of the NIH Women's Health Initiative (1993) / Chapter Skim
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Appendix A: Clinical Trial Exclusion Criteria
Pages 95-100

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From page 95...
... Appendixes
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From page 97...
... Competing Risk invasive cancer of any type in the past 10 years breast cancer at any time (in situ or invasive) · any medical condition associated with predicted survival of less than five years in the judgment of a Clinic physician (e.g., class IV congestive heart failure, obstructive lung disease requiring long-term ventilation or supplemental oxygen in the past, severe chronic liver disease with jaundice or ascites, kidney failure requiring dialysis, sickle eel]
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From page 98...
... Safety reasons endometrial cancer of any stage at any time endometrial hyperplasia at baseline biopsy or endometrial thickness ~ Smm via ultrasonography (no recycling) · malignant melanoma of any stage at any time · non-traumatic thromboembolic event or thromboembolic event associated with estrogen or oral contraceptive use · previous osteoporosis-related fracture being treated with hormone replacement therapy history of bleeding disorder serious enough to require transfusion · known history of hypertriglyceridemia, or lipemic serum leading to diagnosis of hypertriglyceridemia on baseline blood draw · deep vein thrombosis or pulmonary embolism in past six months*
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From page 99...
... . Women wall be eligible if they are following a diabetic diet or a low salt diet · colorectal cancer at any time unable to complete Four-Day Food" Record adequately percent of calories from fat estimated to be 34 or less number of main meals prepared out of home > 10 per week type ~ (insulin-requiring, ketosis-prone)
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Key Terms

  • exclusion criteria
  • additional exclusion
  • hormone replacement
  • past six
  • predicted survival

  • clinical breast
  • condition associated
  • clinic physician
  • detailed criteria
  • retention reasons

  • medical condition
  • clinical trial
  • replacement therapy
  • thromboembolic event
  • trial components

  • breast exams
  • serum leading
  • obstructive lung
  • deep vein
  • daily corticosteroids

  • failure requiring
  • intervention diet
  • pulmonary embolism
  • liver disease
  • previous six

  • severe chronic
  • congestive heart
  • event associated
  • baseline study
  • kidney failure


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