A case of data alteration in the Multiple Risk Factor Intervention Trial (MRFIT). The MRFIT Research Group.
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Biomedical subjects
Publications and source records attributed to N M Simon.
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Blood samples from 23 subjects with chronic renal failure and 19 controls were tested using thrombelastography and other hematologic tests. The uremic subjects were divided into two groups, those who had not yet begun maintenance hemodialysis treatments (12 subjects) and those who had (11 subjects). Compared to those from control subjects, the thrombelastograms from the uremic subjects consistently indicate normal clotting times but significantly elevated amplitudes. The increased amplitudes correlate positively in the dialyzed uremic group with both platelet count and fibrinogen concentration and correlate negatively in both uremic groups with hematocrit. Thrombelastography demonstrates a hypercoagulability in these samples in vitro, despite the prolonged bleeding time that commonly occurs in uremic subjects.
Proximal renal tubular function was studied in 11 patients with severe burn injury. Creatinine clearance was normal or increased in ten patients. Fractional excretion of sodium was less than 1% in ten. Fractional excretion of uric acid and amylase were increased in all but four and two cases, respectively, while absolute clearances of lysozyme and beta 2-microglobulin were increased in all but one patient. Renal threshold phosphate concentration was reduced in four patients. Twenty-four-hour urine glucose excretion exceeded 1 g in five patients, aminoaciduria was noted in eight, and proteinuria, predominantly globulinuria, was present consistently. Metabolic acidosis was seen in one patient, and transient hypokalemia occurred in two. Abnormalities of proximal tubular function were more marked in the five patients with the greatest extent of third-degree burns who died. The cause of proximal tubular dysfunction is not clear and may be related to an adaptive response to severe injury.
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Four patients with pneumatosis cystoides intestinalis were recently treated with oxygen via a close-fitting mask. They responded initially to this therapy, with cessation of all symptoms and, after seven days of treatment, with return of proctoscopic and barium-contrast roentgenographic findings in the colon to normal. However, the disease recurred in one of the four patients after six months. There is a potential hazard of toxic effects from oxygen, and this may be detected by frequent measurement of pulmonary vital capacity. Our experience corroborates the efficacy of oxygen therapy in the treatment of this disorder but we question its long-term effectiveness in all cases.
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A 22 year old man with renal failure associated with salt wasting, retinitis pigmentosa, and imino acid abnormalities is reported. Renal tissue showed changes compatible with medullary cystic disease or juvenile nephronophtisis. Special studies were carried out to clarify the mechanism of renal salt wasting. Retinal pigmentary changes were found in three siblings and a male cousin; in two siblings studied abnormal retinal function was demonstrated. the parents who were first cousins once removed were normal. Fifty kindred members were examined and none showed unequivocal signs of renal disease. Autosomal recessive transmission of ocular and renal disease appeared likely. The separation of medullary cystic disease from juvenile nephronophthisis on the basis of onset and mode of inheritance is probably artificial.
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