Ethical considerations in the use of patients for demonstration.
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Biomedical subjects
Publications and source records attributed to B Lange.
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PURPOSE: The goal was to conduct a phase I/II trial of escalating doses of Idarubicin (Ida) in conjunction with the previously established maximum tolerated dose (MTD) of F-ara-A/ara-C in children with refractory or recurrent acute myeloid leukemia (AML). PATIENTS AND METHODS: We conducted a phase I/II trial in parallel with Children's Cancer Group (CCG) study 0922, which involved dose escalation of Ida at levels of mg/m2, 9 mg/m2, and 12 mg/m2 over 15 minutes on days 0, 1, and 2. As phase I safety was documented by CCG, we increased the dose of Ida given on day 0, 1, and 2 of the F-ara-A/ara-C infusion (F-ara-A: 10.5 mg/m2 over 15 minutes and 1.27 mg/m2/hour for 48 hours followed by ara-C: 390 mg/m2 over 15 minutes and 101 mg/m2/hour for 72 hours). RESULTS: Ten of 15 patients achieved remission. There was one toxic death due to adult respiratory distress syndrome. The median time to an absolute neutrophil count (ANC) > 200/microliter was 29 days; ANC > 1,000/microliter was 41 days; and platelets > 100,000/microliter was 45 days. CONCLUSIONS: A dose of 12 mg/m2/day x 3 of Ida did not exceed dose-limiting toxicity with this combination of F-ara-A/ara-C. Substantial activity of this regimen was seen in pediatric patients with AML.
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The intent of the study was twofold. The primary objective was to identify the reasons why patients remain with a practitioner. The secondary objective was to explore a procedure that practitioners could employ to assess the strengths and weaknesses of the way they and their staff interact with patients. The majority of patients indicated that honesty of their dentist was the primary reason that they continued in a dental practice. Patients also cited cleanliness, professional appearance, knowledge of dentistry, gentleness, concern, and quality of work as factors that influenced their decision to stay in a dental practice. The patient survey forms used in this study were designed to be utilized by a private practitioner. The feedback obtained from the survey may be used to improve patient's perceptions and relationship with a dental practitioner.
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