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Discover 23,476 clinical trials near Baltimore, Maryland. Find research studies in your area.
Showing 22961-22980 of 23,476 trials
NCT00001810
The objective of this study is to evaluate the efficacy, safety and toleration of voriconazole in the primary treatment of systemic or invasive fungal infections due to fungal pathogens for which there is no licensed therapy; and in the secondary treatment of systemic or invasive fungal infections in patients failing or intolerant to treatment with approved systemic antifungal agents. This trial is a Phase II multicenter, open label study investigating the utilization of voriconazole for the treatment of systemic or invasive fungal infections. Enrollment is targeted for 150 patients to be recruited from multiple centers. The patient population will consist of patients with proven, deeply invasive fungal infection for which there is no licensed therapy or if the patient is failing or intolerant to treatment with approved systemic antifungal agents. Voriconazole will be administered initially by a loading dose of 6 mg/kg q12 hours for the first two doses followed by 4 mg/kg q12 hours. Efficacy will be evaluated by clinical, radiological and microbiological response.
NCT00001695
Simultaneous use of alternative or complementary medical therapies by cancer patients undergoing conventional medical treatment is extremely common and may not always be disclosed to the patient's treating physician. Cancer patients undergoing Phase I therapy on clinical trials constitute a special population of patients, since by definition, their prescribed therapy is scientifically unproven in terms of efficacy. Phase I patients are closely monitored for adverse effects in order to identify and characterize the toxicities and to define a tolerable dose of their experimental treatment. Thus, the unrecognized use of alternative therapies by patients actively enrolled in phase I trials may potentially confound rational drug development by causing adverse side effects or by contributing to drug interactions. Examples of clinical toxicities induced by alternative medical treatments include liver dysfunction or renal failure caused by herbal preparations, or hematologic abnormalities, such as eosinophilia-myalgia syndrome caused by tryptophan food supplements. Therefore, it is important to document and determine the prevalence of alternative therapy use in this specific patient population; however, this issue has not previously been examined in a scientifically rigorous manner. We propose to conduct a survey and interview study of phase I cancer patients enrolled in ongoing clinical trials at the National Cancer Institute to determine the prevalence of alternative therapy use in this population. This study will also examine patient attitudes and perceptions regarding their use of alternative therapy as compared with their scientifically-sanctioned phase I experimental therapy. This information has important implications for drug development.