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At least 145 records · Page 8Linked to original sources
PubMed2007

Benefit assessment of therapeutic products: the Centers for Education and Research on Therapeutics.

The ability to manage risk depends critically on an understanding of the degree to which a known risk is balanced by the probability of a clinical benefit. Despite the massive emphasis on risk and risk management in the past few years and the long-term focus on defining benefit in the regulatory system, considerable uncertainty remains about the methods of defining benefit and how to operationalize this knowledge. In this 'think tank,' part of a larger series on risk management, issues were divided into those that can be identified before a study is initiated, those that commonly arise after a study is completed, biomarkers and surrogates, use of benefit findings in defining quality and performance indicators, implementation of findings into health systems and formularies, and methods of comparative trials. Key categories for the establishment of a research agenda to fill in gaps in our understanding of assessing benefit were developed by the group.

Drug Industry↗
PubMed2000

[Therapeutic options in treatment of heel defects. Presentation of an algorithm for therapeutic strategy].

INTRODUCTION: The treatment of soft tissue defects of the foot and ankle region remains a challenge, because special anatomical and physiological properties have to be considered. PATIENTS AND METHODS: The data of 52 patients, who were treated between 1994 and 1998, were analyzed. 48% were posttraumatic defects and were located in the weight bearing zone in 37%. RESULTS: Fifty-nine procedures were used, including skin transplantation in 16 patients, local flaps in 3 cases, regional flaps in 14 cases, and microvascular procedures in 17 cases. Amputation was required in 4 patients. The overall success rate was 92%. Complications occurred in 18 patients. CONCLUSIONS: Using these data and evaluation of the actual literature lead to the development of an algorithm for the treatment of defects in this area. The modern armamentarium of plastic surgery offers the possible different treatment modalities.

Adolescent↗
PubMed2004

Apoptosis in Gliomas: Molecular Mechanisms and Therapeutic Implications.

Understanding apoptosis is often considered a key to understand the genesis of tumors and to devise innovative strategies for their treatment. Similar to other types of cancer, essential pathways regulating apoptosis are also disrupted in malignant gliomas, notably the cell cycle control mechanisms regulated by the p53 and retinoblastoma (RB) proteins and their homologs. Moreover, cultured glioma cells appear not to activate the extrinsic death receptor-dependent apoptotic pathway in response to irradiation or cytotoxic drugs. A preferential expression of antiapoptotic rather than proapoptotic BCL-2 family proteins and high level expression of inhibitor-of-apoptosis proteins (IAP) may be responsible for the failure of glioma cells to activate caspases in response to apoptotic stimuli. Although apoptosis does occur spontaneously in malignant gliomas in vivo, there is little evidence that the current modes of non-surgical treatment, radiotherapy and chemotherapy, mediate their effects via induction of apoptosis, with the possible exception of anaplastic oligodendrogliomas which often show striking tumor regression on neuroimaging. Yet, the induction of apoptosis plays a conceptual role in the majority of novel experimental approaches to malignant glioma which are currently evaluated in cell culture and preclinical rodent models.

Journal Article↗