Medical and pediatric oncology
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Med. Pediatr. Oncol. · Sep 1995
Randomized Controlled Trial Multicenter Study Clinical TrialProspective randomised trial of chemotherapy given before radiotherapy in childhood medulloblastoma. International Society of Paediatric Oncology (SIOP) and the (German) Society of Paediatric Oncology (GPO): SIOP II.
In a multicentre randomised clinical trial 364 children with biopsy proven medulloblastoma were randomly assigned to receive or not pre-radiotherapy chemotherapy. Children with total or subtotal removal of the tumour, no evidence of invasive brain stem involvement, and no evidence of metastatic disease either within or without the cranium were designated "low risk", those with gross residual tumour, evidence of invasive brain stem involvement or metastases in the central nervous system were designated "high risk". ⋯ No benefit for the receipt of pre-radiotherapy chemotherapy could be demonstrated for any group. In addition, a negative interaction was observed between the receipt of the chemotherapy and reduced dose radio-therapy with a particularly poor outcome being observed in this group of children.
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Med. Pediatr. Oncol. · Jan 1991
Randomized Controlled Trial Clinical TrialMidazolam premedication for pediatric bone marrow aspiration and lumbar puncture.
The ability of midazolam, a benzodiazepine, to reduce the distress associated with lumbar puncture and bone marrow aspiration was examined in 23 children with acute lymphocytic leukemia. Patients were randomized to receive 0.2 mg/kg midazolam HCl or placebo intravenously 3-5 min before the procedures, under double-blind conditions. Based on prior experiences, children in both groups anticipated severe pain from these procedures. ⋯ The amnestic effects of midazolam, confirmed in a visual recall/recognition test, appear to account for the decreased pain ratings since the behavioral manifestations were similar in the two groups. There were no adverse drug reactions or significant changes in vital signs. Midazolam warrants further investigation as a premedication for painful diagnostic and treatment procedures in children with cancer.
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Med. Pediatr. Oncol. · Jan 1989
Patients', parents', and oncologists' perceptions of informed consent for bone marrow transplantation.
Bone marrow transplantation (BMT) is gaining increasing acceptance as a therapeutic treatment modality and is being offered to patients even in the early stages of disease in the presence of minimal debilitating symptoms. Despite this, little is known regarding patients' and physicians' perceptions of the process in which informed consent for this controversial and potentially lethal procedure is obtained. Thirty-nine adult BMT patients and the parents of 61 children undergoing BMT and each of their physicians completed a questionnaire concerning their perceptions of the discussion in which consent for BMT was obtained and their evaluation of the consent document. ⋯ The results indicate that on the whole patients and parents evaluated the BMT consultation and consent document favorably, were motivated by their trust in the physician and their belief in BMT as a cure, retained information regarding major points of informed consent from both the consent document and physician discussion, and had considerable difficulty with recall of the specific toxic side effects associated with BMT. Physicians' perceptions, on the other hand, reflected a less positive view of the extent to which patients and parents were actively involved in the consent process and the readability of the consent document. Perceptions of the informed consent process on the part of oncologist-investigators and patients which could impede the goals of informed consent and implications for facilitating the process are discussed.
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Med. Pediatr. Oncol. · Jan 1978
Comparative Study Clinical Trial4-Aminoimidazole-5-carboxamide excretion in acute leukemia.
The urinary excretion of 4-aminimidazole-5-carboxamide (AIC) as been reported to be increased in children with acute leukemia and has been correlated with disease status. Using a modification of the method of Skibba et al [5], determinations were made on urine from 26 children with acute leukemia. The urine from ten normal children served as controls. ⋯ Values for individual patients were not predictive of disease status. One such patient is described. This study demonstrates that chemotherapy, as well as disease status, affects the urinary excretion of AIC in children with acute leukemia.