Abstract:
:The objective of this double-blind, placebo-controlled, dose-escalation study is to evaluate safety, tolerability, and enhancement on healing of thymosin beta-4 (Tbeta-4) administered topically in patients with venous ulcers. Three groups of patients, coming from 10 sites, 5 from Italy and 5 from Poland, will be enrolled sequentially. Twenty-four patients within each group will be randomized to Tbeta-4 or placebo in a 3:1 ratio and will be treated with increasing doses of Tbeta-4. When review safety data show no-dose-limiting adverse events, a new group will be enrolled. So, the study design comprehends 72 patients treated for 84 days and followed for 14 days at the end of treatment. Blood samples will be taken on day 0 and at the end of treatment visit to measure plasma levels of Tbeta-4. Every week each patient is visited and blood samples are taken for clinical chemistry, hematology, coagulation, and urinalysis. Each ulcer is treated with debridement, if necessary, and compression therapy with standard compression stockings class 2. Efficacy parameters are incidence of healing defined as the percentage of patients who have complete closure of the index ulcer at day 84 and, mean time to complete healing. Ulcer area will be calculated by digital planimetry and photographic analysis. The study is ongoing and a total of 21 patients have been enrolled so far in the first treatment group at the lower dose. Patients' compliance and motivated and well-trained teams seem to be the most suitable parameters of a successfully conducted study.
journal_name
Ann N Y Acad Scijournal_title
Annals of the New York Academy of Sciencesauthors
Guarnera G,DE Rosa A,Camerini Rdoi
10.1196/annals.1415.003subject
Has Abstractpub_date
2007-09-01 00:00:00pages
407-12eissn
0077-8923issn
1749-6632pii
annals.1415.003journal_volume
1112pub_type
杂志文章,多中心研究,随机对照试验abstract::Several reports indicate the presence of infection with Anaplasma phagocytophila in Europe. The first case with confirmed human granulocytic ehrlichiosis was reported from Slovenia in 1997. By 2002, 13 patients have been discovered in a prospective study on the etiology of febrile illnesses occurring within six weeks ...
journal_title:Annals of the New York Academy of Sciences
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abstract::One of the challenges facing health and welfare policymakers as well as researchers in most developed countries is the increasing demand for aging services and aged care. Low birth rates and rapid increases in the percentages of elderly people make aging and aged care one of the top-priority issues among the national ...
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abstract::During viewing of a near target, the gain of the visually modulated vestibulo-ocular reflex (vVOR) exceeds 1.0. We investigated whether retinal image slip contributes to this gain increase by measuring responses during strobe illumination. Subjects showed greater gain values during normal versus strobe illumination of...
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journal_title:Annals of the New York Academy of Sciences
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abstract::Increase in the dosage of cellular oncogenes by DNA amplification is a frequent genetic alteration of cancer cells. In neuroblastoma, amplification of the gene MYCN has been associated with aggressively growing cancers and is an indicator for poor prognosis. MYCN amplification is of predictive value in identifying pat...
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journal_title:Annals of the New York Academy of Sciences
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journal_title:Annals of the New York Academy of Sciences
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abstract::Washington State's law for sexually violent predators was enacted in 1990; since then, 14 other states have passed similar laws authorizing civil commitment for dangerous sexual offenders following their prison terms. Although the law has survived constitutional challenges at both the state and in the U.S. Supreme Cou...
journal_title:Annals of the New York Academy of Sciences
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abstract::The potential impact of atrazine (ATZ) on gonadal malformations in larval Xenopus laevis has been controversially discussed, and a hypothesis has been generated that ATZ might induce the estrogen-synthesizing enzyme aromatase, leading to feminization or demasculinization. Recently, extensive long-term studies clearly ...
journal_title:Annals of the New York Academy of Sciences
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abstract::Although much work has been done in the field of circulating DNA, no definitive information on sequencing data of total circulating DNA is available. Characterization of total circulating DNA by sequence analysis may give valuable information about the origin and function of these nucleic acid molecules. Circulating D...
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abstract::Huperzine A has been shown to be useful in the treatment of symptoms of dementia of the Alzheimer type. Our initial attempts to synthesize (-)Huperzine A resulted in the racemic mixture of (+/-)Huperzine A. We have therefore compared the in vitro and in vivo effects of (+/-)Huperzine A with those of (-)Huperzine A in ...
journal_title:Annals of the New York Academy of Sciences
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更新日期:1993-09-24 00:00:00
abstract::The strategy of "manufacturing uncertainty" has been used with great success by polluters and manufacturers of dangerous products to oppose public health and environmental regulation. This strategy entails questioning the validity of scientific evidence on which the regulation is based. While this approach is most ide...
journal_title:Annals of the New York Academy of Sciences
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abstract::Regulation of pulmonary oxygen uptake (VO2p) during exercise depends on cellular energy demand, blood flow, ventilation, oxygen exchange across membranes, and oxygen utilization in the contracting skeletal muscle. In human and animal studies of metabolic processes that control cellular respiration in working skeletal ...
journal_title:Annals of the New York Academy of Sciences
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