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Michael D. Walker, Eben Alexander Jr., William E. Hunt, Carl M. Leventhal, M. Stephen Mahaley Jr., John Mealey, Horace A. Norrell, Guy Owens, Joseph Ransohoff, Charles B. Wilson and Edmund A. Gehan

, specifically 76 6 68 50  total   reported 86 82 73 64   not reported 10 14 23 32 Discussion This study has demonstrated that patients with anaplastic gliomas may be evaluated in controlled, prospective, randomized clinical trials similar to those performed with other diseases. It has further shown that mithramycin used at a maximum dose in a daily schedule for 21 days, starting within several weeks of definitive surgical resection, does not appear to alter the survival course of patients so treated. The

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Arthur A. Ward Jr.

much more competent in providing real therapeutic help in dealing with trauma of the brain and spinal cord, for which we really do very little at the present time. The list could easily be expanded. Randomized Clinical Trials This progress will bring its own problems. As new surgical approaches are developed, techniques must be developed for documenting their efficacy and safety. This has not been done adequately in the past and this lack can be demonstrated in other surgical fields. In 1877, Nikolai Eck carried out the first experimental portocaval shunts

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Arachnoid Cysts July 1979 51 1 10.3171/jns.1979.51.1.0132 Intracavernous Intercarotid Artery with Agenesis of the ICA July 1979 51 1 10.3171/jns.1979.51.1.0132a Editorial Comment July 1979 51 1 1 1 10.3171/jns.1979.51.1.0001 James L. Poppen, M.D., 1903–1978 Charles A. Fager July 1979 51 1 2 4 10.3171/jns.1979.51.1.0002 Randomized clinical trials in the evaluation of surgical innovation Stephen J. Haines July 1979 51 1 5 11 10.3171/jns.1979.51.1.0005 Relative cerebral glucose metabolism evoked by dental-pulp stimulation in

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Stephen J. Haines

T he evaluation and eventual rejection of gastric freezing 31 and internal mammary artery ligation 2 as viable therapeutic techniques are clear examples of the hazards of inadequate early evaluation of new surgical procedures. Similar experiences in other areas of medicine have made the double-blind, randomized clinical trial the standard for evaluation of new medical therapies, especially in clinical pharmacology. 8, 14, 23, 24, 32 In a provocative paper by Deniston and Rosenstock, 15 non-randomized designs have been compared with randomized designs using

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Victor A. Levin, Charles B. Wilson, Richard Davis, William M. Wara, Tana L. Pischer and Lowell Irwin

primary malignant brain tumor; 2) treatment initiated ≤4 weeks after surgery or clinical diagnosis; 3) life expectancy of ≥6 weeks; 4) normal results of complete blood count, platelet count, SMA-12 panel, urinalysis, and prothrombin time; and 5) informed consent to serve as a volunteer in this randomized clinical trial. Of the 133 patients entered into the study, 99 constituted the valid study group ( Table 1 ). TABLE 1 Evaluability status Evaluability No. of Cases no. patients entered 130 no. patients evaluable 99

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Surgical treatment of single brain metastasis

Evaluation of results by computerized tomography scanning

Joseph H. Galicich, Narayan Sundaresan and H. Tzvi Thaler

: Department of Health, Education and Welfare , 1977 , pp 213 – 214 Kramer S, Hendrickson F, Zelen M, et al: Therapeutic trials in the management of metastatic brain tumors by different time/dose fractionation schemes of radiation therapy, in National Cancer Institute Monograph 46. Bethesda, MD: Department of Health, Education and Welfare, 1977, pp 213–214 8. Peto R , Pike MC , Armitage P , et al : Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and examples. Br

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: 483 – 486 , 1960 Dimond EG, Kittle CF, Crockett JE: Comparison of internal mammary artery ligation and sham operation for angina pectoris. Am J Cardiol 5: 483–486, 1960 5. Feinstein AR : The scientific and clinical tribulations of randomized clinical trials. Clin Res 26 : 241 – 244 , 1978 Feinstein AR: The scientific and clinical tribulations of randomized clinical trials. Clin Res 26: 241–244, 1978 6. Fletcher RH , Fletcher SW : Clinical research in general medical journals. A 30-year

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Treatment of spinal epidural metastases

Randomized prospective comparison of laminectomy and radiotherapy

Ronald F. Young, Elisabeth M. Post and Gerald A. King

, 1976 Haddad P, Thaell JF, Kiely JM, et al: Lymphomas of the spinal extradural space. Cancer 38: 1862–1866, 1976 15. Haines SJ : Randomized clinical trials in the evaluation of surgical innovation. J Neurosurg 51 : 5 – 11 , 1979 Haines SJ: Randomized clinical trials in the evaluation of surgical innovation. J Neurosurg 51: 5–11, 1979 16. Hall AJ , Mackay NNS : The results of laminectomy for compression of the cord or cauda equina by extradural malignant tumour. J Bone Joint Surg (Br) 55

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Immunobiology of primary intracranial tumors

Part 4: Levamisole as an immune stimulant in patients and in the ASV glioma model

M. Stephen Mahaley Jr., Paul Steinbok, Patricia Aronin, Lynn Dudka and Doug Zinn

infiltrates in primary glioblastomas and recidivous gliomas. Incidence, fate, and relevance to prognosis in 228 operated cases. J Neurosurg 49 : 854 – 861 , 1978 Palma L, Di Lorenzo N, Guidetti B: Lymphocytic infiltrates in primary glioblastomas and recidivous gliomas. Incidence, fate, and relevance to prognosis in 228 operated cases. J Neurosurg 49: 854–861, 1978 24. Peto R , Pike MC , Armitage P , et al : Design and analysis of randomized clinical trials requiring prolonged observation of each patient. II. Analysis and

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Narayan Sundaresan, Rand Voorhies, Kui-Lam Kwok and H. Tzvi Thaler

, et al : Randomized clinical trials: perspectives on some recent ideas. N Engl J Med 295 : 74 – 80 , 1976 Byar DP, Simon RM, Friedwald WT, et al: Randomized clinical trials: perspectives on some recent ideas. N Engl J Med 295: 74–80, 1976 5. Chalmers TC , Block JB , Lee S : Controlled studies in clinical cancer research. N Engl J Med 287 : 75 – 78 , 1972 Chalmers TC, Block JB, Lee S: Controlled studies in clinical cancer research. N Engl J Med 287: 75–78, 1972 6. Cutler SJ