57 research outputs found

    Clinical Legal Education and the Public Interest in Intellectual Property Law

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    Clinical legal education provides a powerful methodology for students to learn about the relationships among intellectual property law theories, policies and practices; to encounter the experiences of persons who seek protection or who feel the legal regimes of intellectual property impinging on their ability to engage in educational, creative, innovative and culturally significant work; and to develop as lawyers. We describe in this article our motivations for forming an intellectual property law clinic at the American University Washington College of Law, the goals that we seek to achieve, and the tripartite pedagogical structure that we adopted - (1) a seminar built around a year-long simulation that addresses multiple lawyering skills and legal practice settings, (2) a wide variety of live-client student representations performed under close faculty supervision, and (3) weekly case rounds discussions focusing on public interest issues experienced directly by the students in their representations. We provide an example of a particular student representation that illustrates some of the benefits of our clinical model for teaching students about the public interest and intellectual property law doctrines within the framework of teaching about lawyering. We conclude with our reflections on student experiences and the ability of our clinical program to teach intellectual property law and lawyering in concrete factual and policy contexts, helping students better understand the interaction of theory, doctrine and practice in shaping the meaning and consequences of intellectual property regimes. Students came to understand law and lawyering and to see ways to shape their lives as lawyers, through analyzing and evaluating their responses to the interests of their clients, their actions in meeting the demands of a case, their understanding of the relationships among doctrinal areas, and the connection of their activities to the public interest

    Using Fludarabine to Reduce Exposure to Alkylating Agents in Children with Sickle Cell Disease Receiving Busulfan, Cyclophosphamide, and Antithymocyte Globulin Transplant Conditioning: Results of a Dose De-Escalation Trial

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    AbstractHigh-dose busulfan, cyclophosphamide, and antithymocyte globulin (BU-CY-ATG) is the most commonly used conditioning regimen in HLA-matched related hematopoietic cell transplantation for children with sickle cell disease. Disease-free survival with this regimen is now approximately 95%; however, it produces significant morbidity. We hypothesized we could create a less toxic regimen by adding fludarabine (FLU) to BU-CY-ATG and reduce the dosages of busulfan and cyclophosphamide. We conducted a multicenter dose de-escalation trial with the objective of decreasing the doses of busulfan and cyclophosphamide by 50% and 55%, respectively. Using day +28 donor-predominant chimerism as a surrogate endpoint for sustained engraftment, we completed the first 2 of 4 planned levels, enrolling 6 patients at each and reducing the total dose of cyclophosphamide from 200 mg/kg to 90 mg/kg. On the third level, which involved a reduction of i.v. busulfan from 12.8 mg/kg to 9.6 mg/kg, the first 2 patients had host-predominant T cell chimerism, which triggered trial-stopping rules. All 14 patients survive disease-free. No patients suffered severe regimen-related toxicity. Our results suggest BU-FLU-CY-ATG using lower dose CY could be a less toxic yet effective regimen. Further evaluation of this regimen in a full-scale clinical trial is warranted

    Randomized clinical trial of therapeutic music video intervention for resilience outcomes in adolescents/young adults undergoing hematopoietic stem cell transplant: a report from the Children's Oncology Group

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    BACKGROUND: To reduce the risk of adjustment problems associated with hematopoietic stem cell transplant (HSCT) for adolescents/young adults (AYAs), we examined efficacy of a therapeutic music video (TMV) intervention delivered during the acute phase of HSCT to: 1) increase protective factors of spiritual perspective, social integration, family environment, courageous coping, and hope-derived meaning; 2) decrease risk factors of illness-related distress and defensive coping; and 3) increase outcomes of self-transcendence and resilience. METHODS: This was a multisite randomized, controlled trial (COG-ANUR0631) conducted at 8 Children's Oncology Group sites involving 113 AYAs aged 11-24 years undergoing myeloablative HSCT. Participants, randomized to the TMV or low-dose control (audiobooks) group, completed 6 sessions over 3 weeks with a board-certified music therapist. Variables were based on Haase's Resilience in Illness Model (RIM). Participants completed measures related to latent variables of illness-related distress, social integration, spiritual perspective, family environment, coping, hope-derived meaning, and resilience at baseline (T1), postintervention (T2), and 100 days posttransplant (T3). RESULTS: At T2, the TMV group reported significantly better courageous coping (Effect Size [ES], 0.505; P = .030). At T3, the TMV group reported significantly better social integration (ES, 0.543; P = .028) and family environment (ES, 0.663; P = .008), as well as moderate nonsignificant effect sizes for spiritual perspective (ES, 0.450; P = .071) and self-transcendence (ES, 0.424; P = .088). CONCLUSIONS: The TMV intervention improves positive health outcomes of courageous coping, social integration, and family environment during a high-risk cancer treatment. We recommend the TMV be examined in a broader population of AYAs with high-risk cancers

    Using Fludarabine to Reduce Exposure to Alkylating Agents in Children with Sickle Cell Disease Receiving Busulfan, Cyclophosphamide, and Antithymocyte Globulin Transplant Conditioning: Results of a Dose De-Escalation Trial

    Get PDF
    AbstractHigh-dose busulfan, cyclophosphamide, and antithymocyte globulin (BU-CY-ATG) is the most commonly used conditioning regimen in HLA-matched related hematopoietic cell transplantation for children with sickle cell disease. Disease-free survival with this regimen is now approximately 95%; however, it produces significant morbidity. We hypothesized we could create a less toxic regimen by adding fludarabine (FLU) to BU-CY-ATG and reduce the dosages of busulfan and cyclophosphamide. We conducted a multicenter dose de-escalation trial with the objective of decreasing the doses of busulfan and cyclophosphamide by 50% and 55%, respectively. Using day +28 donor-predominant chimerism as a surrogate endpoint for sustained engraftment, we completed the first 2 of 4 planned levels, enrolling 6 patients at each and reducing the total dose of cyclophosphamide from 200 mg/kg to 90 mg/kg. On the third level, which involved a reduction of i.v. busulfan from 12.8 mg/kg to 9.6 mg/kg, the first 2 patients had host-predominant T cell chimerism, which triggered trial-stopping rules. All 14 patients survive disease-free. No patients suffered severe regimen-related toxicity. Our results suggest BU-FLU-CY-ATG using lower dose CY could be a less toxic yet effective regimen. Further evaluation of this regimen in a full-scale clinical trial is warranted

    Clinical Legal Education and the Public Interest in Intellectual Property Law

    Get PDF
    Clinical legal education provides a powerful methodology for students to learn about the relationships among intellectual property law theories, policies and practices; to encounter the experiences of persons who seek protection or who feel the legal regimes of intellectual property impinging on their ability to engage in educational, creative, innovative and culturally significant work; and to develop as lawyers. We describe in this article our motivations for forming an intellectual property law clinic at the American University Washington College of Law, the goals that we seek to achieve, and the tripartite pedagogical structure that we adopted - (1) a seminar built around a year-long simulation that addresses multiple lawyering skills and legal practice settings, (2) a wide variety of live-client student representations performed under close faculty supervision, and (3) weekly case rounds discussions focusing on public interest issues experienced directly by the students in their representations.We provide an example of a particular student representation that illustrates some of the benefits of our clinical model for teaching students about the public interest and intellectual property law doctrines within the framework of teaching about lawyering. We conclude with our reflections on student experiences and the ability of our clinical program to teach intellectual property law and lawyering in concrete factual and policy contexts, helping students better understand the interaction of theory, doctrine and practice in shaping the meaning and consequences of intellectual property regimes. Students came to understand law and lawyering and to see ways to shape their lives as lawyers, through analyzing and evaluating their responses to the interests of their clients, their actions in meeting the demands of a case, their understanding of the relationships among doctrinal areas, and the connection of their activities to the public interest
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