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Clinical trial managers and investigators may need to brush up on the regulations regarding investigational device exemption (IDE) since researchers and research staff often forget about the three major categories of compliance regulations, an expert advises.
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Standard treatment for recurrent, diffuse non-Hodgkins lymphoma remains to be established, but several studies have indicated that autologous stem cell transplant has resulted in improved survival. For those with bulky recurrence, pre-transplant, second-line chemotherapy is recommended. In this setting, an optimal regimen would not commonly produce severe marrow toxicity as mobilization of stem cells will be required for optimal reconstitution after transplant.
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The number of circulating tumor cells before treatment is an independent predictor of progression-free survival and overall survival in patients with metastatic breast cancer.
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Erythromycin and the Risk of Sudden Death; Vaccine Shortage Putting Americans At Risk; FDA Actions.
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Approximately 20% of patients with colorectal cancer will have hepatic metastases at the time of original presentation. Partial hepatectomy has become increasingly used in the treatment of liver metastases, but the timing of this procedure for those who present with liver involvement remains an unsettled question. The current single-institution experience would suggest that for selected patients, a simultaneous, one-stage procedure offers a safe and effective treatment strategy.
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Fit elderly patients benefit at least to the same extent from palliative chemotherapy with 5-FU as younger patients. Infusional 5-FU was shown to be more effective than bolus 5-FU in both age groups. Therefore, standardized palliative chemotherapy should generally be offered to elderly patients and they should not be excluded from clinical trials.
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Breast tissue density, as determined by mammography, is known to be a risk factor for the development of invasive breast cancer. In the current analysis of a subgroup of patients participating in the NSABP B-17 trial, those women with highly dense breast tissue were found to have significantly more subsequent breast cancer. Thus, a quantitative assessment of breast density may prove useful in assessment of additional breast cancer risk for patients having breast-conserving surgery for DCIS.
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Some physicians advocate early, aggressive therapy to help reduce low-density lipoprotein (LDL) cholesterol levels. One new study, however, indicates that patients treated with high-dose simvastatin (Zocor) did not show a significant reduction in the primary composite endpoint of cardiovascular death, nonfatal myocardial infarction, readmission for acute coronary syndrome (ACS), and stroke.
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Many elderly Americans still are being prescribed potentially inappropriate medications, according to a study published in the Aug. 9/23 issue of the Archives of Internal Medicine.
