Sixty-eight patients with malodorous lesions were treated with a topical 0.8% metronidazole gel for periods varying from a few days to 15 months. The gel completely controlled the foul smell of 34 (50%) lesions; had a reasonable effect on 31 (46%) and no effect on three. One patient with an infected leg ulcer was reported to have a skin irritation after seven days treatment with the gel. No other possible adverse events were reported.
OBJECTIVES To evaluate the feasibility of implementing a diet‐based intervention in men with prostate cancer on active surveillance, as changes in diet might potentially inhibit the progression of prostate cancer. PATIENTS AND METHODS As part of the Men’s Eating and Living (MEAL) Study (a multicentre pilot trial of a diet‐based intervention for prostate cancer) 43 men aged 50–80 years with prostate cancer and on active surveillance were randomized to receive either telephone‐based dietary counselling or standardized, written nutritional information. Telephone counselling targets included increased intakes of vegetables (particularly cruciferous vegetables and tomato products), whole grains, and beans/legumes. Dietary intakes and plasma carotenoid levels were assessed at baseline and at after 6 months. RESULTS In the intervention arm the mean daily intakes of total vegetables, crucifers and tomato products increased by 71%, 180% and 265%, respectively ( P < 0.05); in the control arm there were no significant changes in mean intakes of these components. Similarly, in the intervention arm, mean plasma levels of α‐carotene, β‐carotene, lutein, lycopene and total carotenoids increased by 37%, 32%, 23%, 30% and 25%, respectively ( P < 0.05); in the control arm there were no significant changes in plasma levels of these components. There were no significant changes in either group in whole grain, beans/legumes, or fat intake. CONCLUSIONS Telephone‐based dietary counselling increases vegetable intake and plasma concentrations of potentially anticarcinogenic carotenoids in men with prostate cancer on active surveillance. These data support the feasibility of implementing clinical trials of diet‐based interventions in this population.
As educators, we seek to empower students and ourselves to make connections with the broader contexts and implications of experiences. This article explores how these connections are made in Barbara Kingsolver's novel Animal Dreams (1990). It is my contention that this novel connects to place and community through historical readings of landscape; that as we read this novel we engage in own personal experience with memory and history and understand their centrality and contingency; and that as educators, we come to understand through this novel the importance of critically reading histories, for it is the process of deconstructing and reconstituting personal and community histories that reveals to the protagonist of the novel-and to its readers-the importance of the role of teacher. This process links with landscape, community, and place by revealing how history, community, and narrator are reclaimed through deconstruction and reconstitution of memory and of histories and social and ecological practices. I will examine-through the context of Kingsolver's Animal Dreams and through critical readings-the importance of community and sense of place in how we make meaning, the importance of in how we to connect to community and sense of place, and how landscape reveals our unwitting autobiography (Lewis 1979, p. 12) and thus leads us, through critical readings of naturalized constructions and transcendent theories, to the multiplicity of possibilities that lies in the gaps and silences
Valoctocogene roxaparvovec (AAV5-hFVIII-SQ) is a gene therapy evaluated in the phase 3 GENEr8-1 trial that provides endogenous factor VIII (FVIII) production to prevent bleeding in people with severe hemophilia A and represents an alternative to emicizumab, a recombinant antibody mimicking the function of FVIII. Individuals receiving emicizumab were excluded from GENEr8-1 enrollment since emicizumab was then an investigational therapy. This study aimed to utilize pharmacokinetic simulations to provide guidance on maintaining hemostatic control while transitioning patients from emicizumab to valoctocogene roxaparvovec gene therapy. A published emicizumab pharmacokinetic model, based on data from the HAVEN clinical trials, was used to simulate in vivo emicizumab concentrations and merged with FVIII activity time-course data for 134 GENEr8-1 participants to estimate bleeding risk at weekly intervals post-infusion with valoctocogene roxaparvovec. The analysis examined 3 approved emicizumab dosing regimens for 2 transition scenarios; first, the last emicizumab dose given the same day as infusion, and second, given 4 weeks after valoctocogene roxaparvovec. Discontinuation of emicizumab the day of valoctocogene roxaparvovec infusion compared with continued dosing for 4 weeks offered similar levels of hemostatic control. The time course for bleeding risk was comparable across the emicizumab dosing regimens for both scenarios. An algorithm to provide guidance for discontinuing emicizumab was developed based on these results. To guide how treatment decisions for emicizumab discontinuation may vary among individuals, theoretical case examples were developed based on participants of GENEr8-1. Regardless of the emicizumab dose or dosing regimen, pharmacokinetic simulations showed no meaningful difference in the risk of bleeding related to FVIII and FVIII equivalent activity determined by the dynamic balance of decaying emicizumab levels and increasing gene therapy–derived endogenous FVIII. These original data suggest individuals on emicizumab prophylaxis can safely transition to valoctocogene roxaparvovec. COIs for presenting author. Suresh Agarwal is an employee and stockholder of BioMarin Pharmaceutical Inc.
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