How Should Congress Respond to McDonnell?

Discussion of question of whether McDonnell was essentially right or wrong. Should Congress act to change the McDonnell rule? Should the Supreme Court reconsider it? What would be an alternative or a better way, if there is one, to approach the question of public corruption prosecution

Influence of Sex/Gender and Race on Responses to Raltegravir Combined With Tenofovir-Emtricitabine in Treatment-Naive Human Immunodeficiency Virus-1 Infected Patients: Pooled Analyses of the STARTMRK and QDMRK Studies.

BACKGROUND: Antiretroviral therapy in human immunodeficiency virus (HIV)-infected women and blacks merits particular scrutiny because these groups have been underrepresented in clinical trials. METHODS: To document the effects of raltegravir across sex and racial lines, we conducted a pooled subgroup analysis of the efficacy and safety of raltegravir 400 mg BID plus tenofovir-emtricitabine by sex (women vs men) and self-identified race (black vs non-black) using phase 3 studies in treatment-naive patients. RESULTS: Study participants included 42 black women, 102 non-black women, 48 black men, and 477 non-black men. Clade B infections were less common in women (43.8%) than men (84.6%) and in blacks (45.6%) than non-blacks (80.5%). Baseline CD4 counts were ≤200 cells/µL in 52.2% of blacks and 31.6% of non-blacks. Black men had the largest proportion of patients with baseline CD4 counts/µL and the highest nontreatment-related discontinuation rate among the 4 sex-by-race subgroups. Human immunodeficiency virus-ribonucleic acid levels/mL were achieved at week 48 in 92.7% (95% confidence interval [CI], 80.1-98.5) of black women, 93.6% (95% CI, 86.6-97.6) of non-black women, 82.9% (95% CI, 67.9-92.8) of black men, and 91.4% (95% CI, 88.4-93.8) of non-black men. Serious clinical adverse events were reported in 9.0% of women versus 8.8% of men and in 11.1% of blacks versus 8.5% of non-blacks. CONCLUSIONS: In this post hoc analysis of patients with previously untreated HIV-1 infection receiving raltegravir plus tenofovir-emtricitabine, generally comparable results were achieved across sex and racial subgroups. However, black men had a lower response rate than either black women or non-black men, partially attributable to lower baseline CD4 counts and higher discontinuation rates

The Book Everybody Read: Vernacular Translations of Sacrobosco’s Sphere in the Sixteenth Century

This article presents four detailed case studies of sixteenth-century vernacular translations of Sacrobosco’s De sphaera. Previous scholarship has highlighted the important role of Sacrobosco’s Sphere in medieval and early modern universities, where it served as an introductory astronomy text. We argue that the Sphere was more than a university teaching text. It was translated many times and was accessible to a wide range of people. The popularity of the Sphere suggests widespread interest in cosmological questions. We suggest that the text was a profitable one for early modern printers, who strove to identify books that would be reliable sellers. We also argue that the Sphere was not a static text. Rather, translators and editors added commentaries and other supplemental material that corrected and updated Sacrobosco’s original text and demonstrated the practical utility of this information. We contend that the Sphere was actually an important vehicle for disseminating new information about the cosmos.Yeshttps://us.sagepub.com/en-us/nam/manuscript-submission-guideline

Library Analytics Investigation Team Recommendations

The University of Michigan Library’s Technology Alignment and Stewardship Committee charged the Library Analytics Investigation Team in the Winter 2016 cycle. The team met from April through September of 2016 to investigate processes to provide library-generated data to library staff for service improvement and/or research investigations.http://deepblue.lib.umich.edu/bitstream/2027.42/134406/1/Library Analytics Investigation Team Report.pdfDescription of Library Analytics Investigation Team Report.pdf : Investigation Team Repor

Allopregnanolone preclinical acute pharmacokinetic and pharmacodynamic studies to predict tolerability and efficacy for Alzheimer's disease.

To develop allopregnanolone as a therapeutic for Alzheimer's disease, we investigated multiple formulations and routes of administration in translationally relevant animal models of both sexes. Subcutaneous, topical (transdermal and intranasal), intramuscular, and intravenous allopregnanolone were bolus-administered. Pharmacokinetic analyses of intravenous allopregnanolone in rabbit and mouse indicated that peak plasma and brain levels (3-fold brain/plasma ratios) at 5min were sufficient to activate neuroregenerative responses at sub-sedative doses. Slow-release subcutaneous suspension of allopregnanolone displayed 5-fold brain/plasma ratio at Cmax at 30min. At therapeutic doses by either subcutaneous or intravenous routes, allopregnanolone mouse plasma levels ranged between 34-51ng/ml by 30min, comparable to published endogenous human level in the third trimester of pregnancy. Exposure to subcutaneous, topical, intramuscular, and intravenous allopregnanolone, at safe and tolerable doses, increased hippocampal markers of neurogenesis including BrdU and PCNA in young 3xTgAD and aged wildtype mice. Intravenous allopregnanolone transiently and robustly phosphorylated CREB within 5min and increased levels of neuronal differentiation transcription factor NeuroD within 4h. Neurogenic efficacy was achieved with allopregnanolone brain exposure of 300-500hr*ng/g. Formulations were tested to determine the no observable adverse effect level (NOAEL) and maximally tolerated doses (MTD) in male and female rats by sedation behavior time course. Sex differences were apparent, males exhibited ≥40% more sedation time compared to females. Allopregnanolone formulated in sulfobutyl-ether-beta-cyclodextrin at optimized complexation ratio maximized allopregnanolone delivery and neurogenic efficacy. To establish the NOAEL and MTD for Allo-induced sedation using a once-per-week intravenous regenerative treatment regimen: In female rats the NOAEL was 0.5mg/kg and MTD 2mg/kg. The predicted MTD in human female is 0.37mg/kg. In male rats the NOAEL and MTD were less than those determined for female. Outcomes of these PK/PD studies predict a safe and efficacious dose range for initial clinical trials of allopregnanolone for Alzheimer's disease. These findings have translational relevance to multiple neurodegenerative conditions

Patient/Family Education for Newly Diagnosed Pediatric Oncology Patients

There is a paucity of data to support evidence-based practices in the provision of patient/family education in the context of a new childhood cancer diagnosis. Since the majority of children with cancer are treated on pediatric oncology clinical trials, lack of effective patient/family education has the potential to negatively affect both patient and clinical trial outcomes. The Children’s Oncology Group Nursing Discipline convened an interprofessional expert panel from within and beyond pediatric oncology to review available and emerging evidence and develop expert consensus recommendations regarding harmonization of patient/family education practices for newly diagnosed pediatric oncology patients across institutions. Five broad principles, with associated recommendations, were identified by the panel, including recognition that (1) in pediatric oncology, patient/family education is family-centered; (2) a diagnosis of childhood cancer is overwhelming and the family needs time to process the diagnosis and develop a plan for managing ongoing life demands before they can successfully learn to care for the child; (3) patient/family education should be an interprofessional endeavor with 3 key areas of focus: (a) diagnosis/treatment, (b) psychosocial coping, and (c) care of the child; (4) patient/family education should occur across the continuum of care; and (5) a supportive environment is necessary to optimize learning. Dissemination and implementation of these recommendations will set the stage for future studies that aim to develop evidence to inform best practices, and ultimately to establish the standard of care for effective patient/family education in pediatric oncology

Perspectives on “Giving Back”: A Conversation Between Researcher and Refugee

Our chapter—“Perspectives on ‘giving back’: A conversation between researcher and refugee”—offers personal reflections on the ethics of research with refugees and what it means for researchers to “give back” to refugee participants beyond “policy impact”. Written as a dialogue between an academic and a Rohingya refugee youth leader, we explore the blurry lines between academic work and advocacy when the issues of refugee protection are pressing, as well as the appropriateness of researchers giving monetary donations and volunteering for refugee causes as payback for data. In this chapter, we also examine what it means to build trust and relationships between researchers and refugees, and how too often researchers fail to develop meaningful research interactions with refugee participants who share their time, energy and personal stories of vulnerability

African Health OER Network Impact Research Plan

The goal of the evaluation research is to demonstrate the value and impact of the Network to funders, existing and potential institutional partners, OER creators and users, networks of African health education providers, and the international OER community. The successful 2010 Network grant proposal to the William and Flora Hewlett Foundation included a preliminary logic model and proposed a set of indicators for the first two years of the Network. This working paper reflects a revised understanding of how to promote OER to support health education in Africa, how to demonstrate the impact of OER on the health education sector, and when to expect various outcomes.William and Flora Hewlett Foundationhttps://deepblue.lib.umich.edu/bitstream/2027.42/149179/1/2011.05.09_health_oer_network_impactresearchplan.pdfDescription of 2011.05.09_health_oer_network_impactresearchplan.pdf : Working Document (May 2011) (PDF