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5. Defining the trials nurses’ role in operationalising a medicinal cannabis clinical trial

Author

Razmovski-Naumovski, V, West, PA, Bellemore, F, Byfieldt, N, Bellamy, D, Chye, R, Clark, K, Martin, JH, Fazekas, B, Phillips, JL, and Agar, MR

Subjects
1110 Nursing, Nursing
Abstract

Background: With increasing use of medicinal cannabis for symptom management, clinical trials nurses need to consider the various legal, social, ethical, and interdisciplinary care issues of implementing these clinical trials, especially in a palliative care population. Aim: To define the trials nurses’ role in operationalising a medicinal cannabis pharmacokinetic inpatient trial in an advanced cancer population. Methods: A qualitative, descriptive design incorporating case study methodology was used. Data were collected from minuted meetings, field notes, telephone, and email discussions involving trials nurses at two palliative care sites. Data were integrated and synthesised to identify the key considerations required to operationalise the trial and define the trials nurses’ role. Findings: Three key considerations were identified: (i) Normalising the trial, (ii) Creating the environment to undertake the trial, and (iii) Managing the complexity. The trials nurses’ role was explored through subthemes of these considerations including: their understanding of the purpose of the research and training in the protocol; organising inpatient resources, pharmacy requirements and managing the external scrutiny; participant recruitment, staffing requirements, safety, and supporting caregivers. Discussion: This study emphasises the multifactorial role of the trials nurses in managing a complex palliative care trial, and the importance of their early involvement and recognition as the vital link between all parties. Conclusion: Defining the trials nurses’ role, within the confines of the protocol, the context of efficient nursing processes and ensuring a patient-centred approach enabled the operationalisation of a Phase I/II medicinal cannabis trial which will have global impact.

Published
2021

10. Safety and Immunogenicity of the Heterosubtypic Influenza A Vaccine MVA-NP+M1 Manufactured onthe AGE1.CR.pIX Avian Cell Line

Author

Folegatti, P, Bellamy, D, Flaxman, A, Mair, C, Ellis, C, Ramon, R, Lopez, F, Mitton, C, Baker, M, Poulton, I, Lawrie, A, Roberts, R, Minassian, A, Ewer, K, Evans, T, Hill, A, and Gilbert, S

Abstract

Seasonal influenza infections have a significant global impact leading to increased health and economic burden. The efficacy of currently available seasonal influenza vaccines targeting polymorphic surface antigens has historically been suboptimal. Cellular immune responses against highly conserved Influenza A virus antigens, such as nucleoprotein (NP) and matrix protein-1 (M1), have previously been shown to be associated with protection from disease, whilst viral-vectored vaccines are an effective strategy to boost cell-mediated immunity. We have previously demonstrated that MVA encoding NP and M1 can induce potent and persistent T cell responses against influenza. In this Phase I study, we evaluated the safety and immunogenicity of MVA-NP+M1, which was newly manufactured on an immortalized cell line, in six healthy adult participants. The vaccine was well-tolerated with only mild to moderate adverse events that resolved spontaneously and were comparable to previous studies with the same vaccine manufactured in chick embryo fibroblasts. A significant increase in vaccine-specific T cell responses was detected seven days after immunization and was directed against both antigens in the vector insert. This small Phase I study supports progression of this vaccine to a Phase IIb study to assess immunogenicity and additional protective efficacy in older adults receiving licensed seasonal influenza vaccines.

Published
2019

47. Love Triumphant : or, The Rival Goddesses. . Perform'd on Easter-Monday, By the Young Ladies of Mrs. Bellamy's School (as their Publick Breaking-Up Exercise) with the General Applause and Approbation of Their Friends. To which are Added, Some Original Poems, and Translations. Never before Publish'd.

Author

Bellamy, D. (Daniel), b. 1687. and Bellamy, D. (Daniel), b. 1687.

Abstract

Available for non-commercial, internal use by students, staff, and faculty at the University of Michigan for academic and research purposes only., Preliminaries omitted., Transcribed from : Love Triumphant : or, The Rival Goddesses. A Pastoral Opera [by Daniel Bellamy]. Perform'd on Easter-Monday, By the Young Ladies of Mrs. Bellamy's School (as their Publick Breaking-Up Exercise) with the General Applause and Approbation of Their Friends. To which are Added, Some Original Poems, and Translations. Never before Publish'd. London : Printed for, and Sold only by Mrs. Bellamy [etc.], 1722., English verse drama database. Cambridge, England : Chadwyck-Healey Ltd., 1994., (DLPSID) V2.0653, http://name.umdl.umich.edu/BAY7617, Copyright (c) 1994-1995 Chadwyck-Healey, Inc. Do not export or print from this database without checking the Copyright Conditions to see what is permitted., This collection is restricted to use at licensed institutions.

Published
1995

48. Vanquish'd Love : or the Jealous Queen. . A DramaticEntertainment.

Author

Bellamy, D. (Daniel), b. 1687. and Bellamy, D. (Daniel), b. 1687.

Abstract

Available for non-commercial, internal use by students, staff, and faculty at the University of Michigan for academic and research purposes only., Preliminaries omitted., Transcribed from : Miscellanies in Prose and Verse : Consisting of Dramatick Pieces, Poems, Humorous Tales, Fables, &c. I. Vanquish' Love : Or, the Jealous Queen. II. The Rival Nymphs : Or, the Merry Swain. III. Innocence Betray'd : Or, the Royal Imposter. IV Love Triumphant : Or, the Rival Goddesses. V. Three Select Scenes of the celebrated Guarini's Pastor Fido, in Italian and English. VI. Select Aesopian Tales, in Prose and Verse paraphrastically translated from Phraedrus, Cambray, and Others. ... By D. Bellamy. London : Printed for J. Hodges [etc.], 1739., English verse drama database. Cambridge, England : Chadwyck-Healey Ltd., 1994., (DLPSID) V2.0651, http://name.umdl.umich.edu/BAY7619, Copyright (c) 1994-1995 Chadwyck-Healey, Inc. Do not export or print from this database without checking the Copyright Conditions to see what is permitted., This collection is restricted to use at licensed institutions.

Published
1995

49. Innocence Betray'd : or, the Royal Impostor. . A DramaticEntertainment, of two acts.

Author

Bellamy, D. (Daniel), b. 1687. and Bellamy, D. (Daniel), b. 1687.

Abstract

Available for non-commercial, internal use by students, staff, and faculty at the University of Michigan for academic and research purposes only., Preliminaries omitted., Transcribed from : Miscellanies in Prose and Verse : Consisting of Dramatick Pieces, Poems, Humorous Tales, Fables, &c. I. Vanquish' Love : Or, the Jealous Queen. II. The Rival Nymphs : Or, the Merry Swain. III. Innocence Betray'd : Or, the Royal Imposter. IV Love Triumphant : Or, the Rival Goddesses. V. Three Select Scenes of the celebrated Guarini's Pastor Fido, in Italian and English. VI. Select Aesopian Tales, in Prose and Verse paraphrastically translated from Phraedrus, Cambray, and Others. ... By D. Bellamy. London : Printed for J. Hodges [etc.], 1739., English verse drama database. Cambridge, England : Chadwyck-Healey Ltd., 1994., (DLPSID) V2.0652, http://name.umdl.umich.edu/BAY7616, Copyright (c) 1994-1995 Chadwyck-Healey, Inc. Do not export or print from this database without checking the Copyright Conditions to see what is permitted., This collection is restricted to use at licensed institutions.

Published
1995

50. Three Select Scenes in Italian and English, of a celebrated Musical Entertainment, Entitled Il Pastor Fido. .

Author

Bellamy, D. (Daniel), b. 1687. and Bellamy, D. (Daniel), b. 1687.

Abstract

Available for non-commercial, internal use by students, staff, and faculty at the University of Michigan for academic and research purposes only., Preliminaries omitted., Transcribed from : Miscellanies in Prose and Verse : Consisting of Dramatick Pieces, Poems, Humorous Tales, Fables, &c. I. Vanquish' Love : Or, the Jealous Queen. II. The Rival Nymphs : Or, the Merry Swain. III. Innocence Betray'd : Or, the Royal Imposter. IV Love Triumphant : Or, the Rival Goddesses. V. Three Select Scenes of the celebrated Guarini's Pastor Fido, in Italian and English. VI. Select Aesopian Tales, in Prose and Verse paraphrastically translated from Phraedrus, Cambray, and Others. ... By D. Bellamy. London : Printed for J. Hodges [etc.], 1739., English verse drama database. Cambridge, England : Chadwyck-Healey Ltd., 1994., (DLPSID) V2.0654, http://name.umdl.umich.edu/BAY7618, Copyright (c) 1994-1995 Chadwyck-Healey, Inc. Do not export or print from this database without checking the Copyright Conditions to see what is permitted., This collection is restricted to use at licensed institutions.

Published
1995

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