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4. Safety and efficacy of factor XIa inhibition with milvexian for secondary stroke prevention (AXIOMATIC-SSP): a phase 2, international, randomised, double-blind, placebo-controlled, dose-finding trial

Author

Sharma, Mukul, Molina, Carlos A, Toyoda, Kazunori, Bereczki, Daniel, Bangdiwala, Shrikant I, Kasner, Scott E, Lutsep, Helmi L, Tsivgoulis, Georgios, Ntaios, George, Czlonkowska, Anna, Shuaib, Ashfaq, Amarenco, Pierre, Endres, Matthias, Yoon, Byung-Woo, Tanne, David, Toni, Danilo, Yperzeele, Laetitia, von Weitzel-Mudersbach, Paul, Sampaio Silva, Gisele, Avezum, Alvaro, Dawson, Jesse, Strbian, Daniel, Tatlisumak, Turgut, Eckstein, Jens, Ameriso, Sebastián F, Weber, Joerg R, Sandset, Else Charlotte, Goar Pogosova, Nana, Lavados, Pablo M, Arauz, Antonio, Gailani, David, Diener, Hans-Christoph, Bernstein, Richard A, Cordonnier, Charlotte, Kahl, Anja, Abelian, Grigor, Donovan, Mark, Pachai, Chahin, Li, Danshi, and Hankey, Graeme J

Published
2024
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5. Apixaban versus no anticoagulation for the prevention of venous thromboembolism in children with newly diagnosed acute lymphoblastic leukaemia or lymphoma (PREVAPIX-ALL): a phase 3, open-label, randomised, controlled trial

Author

O'Brien, Sarah H, Rodriguez, Vilmarie, Lew, Glen, Newburger, Jane W, Schultz, Corinna L, Orgel, Etan, Derr, Kimberly, Ranalli, Mark A, Esbenshade, Adam J, Hochberg, Jessica, Kang, Hyoung Jin, Dinikina, Yulia, Mills, Donna, Donovan, Mark, Dyme, Joshua L, Favatella, Nicholas A, and Mitchell, Lesley G

Published
2024
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7. Rationale and design of the AXIOMATIC-SSP phase II trial: Antithrombotic treatment with factor XIa inhibition to Optimize Management of Acute Thromboembolic events for Secondary Stroke Prevention

Author

Sharma, Mukul, Molina, Carlos A., Toyoda, Kazunori, Bereczki, Daniel, Kasner, Scott E., Lutsep, Helmi L., Tsivgoulis, Georgios, Ntaios, George, Czlonkowska, Anna, Shuaib, Ashfaq, Amarenco, Pierre, Endres, Matthias, Diener, Hans Christoph, Gailani, David, Kahl, Anja, Donovan, Mark, Perera, Vidya, Li, Danshi, and Hankey, Graeme J.

Published
2022
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9. Reassessing Phase II Heart Failure Clinical Trials

Author

Butler, Javed, Hamo, Carine E, Udelson, James E, O'Connor, Christopher, Sabbah, Hani N, Metra, Marco, Shah, Sanjiv J, Kitzman, Dalane W, Teerlink, John R, Bernstein, Harold S, Brooks, Gabriel, Depre, Christophe, DeSouza, Mary M, Dinh, Wilfried, Donovan, Mark, Frische-Danielson, Regina, Frost, Robert J, Garza, Dahlia, Gohring, Udo-Michael, Hellawell, Jennifer, Hsia, Judith, Ishihara, Shiro, Kay-Mugford, Patricia, Koglin, Joerg, Kozinn, Marc, Larson, Christopher J, Mayo, Martha, Gan, Li-Ming, Mugnier, Pierrre, Mushonga, Sekayi, Roessig, Lothar, Russo, Cesare, Salsali, Afshin, Satler, Carol, Shi, Victor, Ticho, Barry, van der Laan, Michael, Yancy, Clyde, Stockbridge, Norman, and Gheorghiade, Mihai

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Clinical Research, Cardiovascular, Heart Disease, Clinical Trials and Supportive Activities, Cardiovascular Agents, Clinical Trials, Phase II as Topic, Consensus, Heart Failure, Humans, Research Design, Treatment Outcome, United States, United States Food and Drug Administration, clinical trial, heart failure, mortality, safety, Biochemistry and Cell Biology, Cardiorespiratory Medicine and Haematology, Medical Physiology, Cardiovascular System & Hematology, Cardiovascular medicine and haematology, Medical physiology
Abstract

The increasing burden and the continued suboptimal outcomes for patients with heart failure underlines the importance of continued research to develop novel therapeutics for this disorder. This can only be accomplished with successful translation of basic science discoveries into direct human application through effective clinical trial design and execution that results in a substantially improved clinical course and outcomes. In this respect, phase II clinical trials play a pivotal role in determining which of the multitude of potential basic science discoveries should move to the large and expansive registration trials in humans. A critical examination of the phase II trials in heart failure reveals multiple shortcomings in their concept, design, execution, and interpretation. To further a dialogue on the challenges and potential for improvement and the role of phase II trials in patients with heart failure, the Food and Drug Administration facilitated a meeting on October 17, 2016, represented by clinicians, researchers, industry members, and regulators. This document summarizes the discussion from this meeting and provides key recommendations for future directions.

Published
2017

11. Poroelastic behavior and water permeability of human skin at the nanoscale

Author

Oftadeh, Ramin, Azadi, Mojtaba, Donovan, Mark, Langer, Jessica, Liao, I-Chien, Ortiz, Christine, Grodzinsky, Alan J, Luengo, Gustavo S, Oftadeh, Ramin, Azadi, Mojtaba, Donovan, Mark, Langer, Jessica, Liao, I-Chien, Ortiz, Christine, Grodzinsky, Alan J, and Luengo, Gustavo S

Abstract

Topical skin care products and hydrating compositions (moisturizers or injectable fillers) have been used for years to improve the appearance of, for example facial wrinkles, or to increase “plumpness”. Most of the studies have addressed these changes based on the overall mechanical changes associated with an increase in hydration state. However, little is known about the water mobility contribution to these changes as well as the consequences to the specific skin layers. This is important as the biophysical properties and the biochemical composition of normal stratum corneum, epithelium, and dermis vary tremendously from one another. Our current studies and results reported here have focused on a novel approach (dynamic atomic force microscopy-based nanoindentation) to quantify biophysical characteristics of individual layers of ex vivo human skin. We have discovered that our new methods are highly sensitive to the mechanical properties of individual skin layers, as well as their hydration properties. Furthermore, our methods can assess the ability of these individual layers to respond to both compressive and shear deformations. In addition, since human skin is mechanically loaded over a wide range of deformation rates (frequencies), we studied the biophysical properties of skin over a wide frequency range. The poroelasticity model used helps to quantify the hydraulic permeability of the skin layers, providing an innovative method to evaluate and interpret the impact of hydrating compositions on water mobility of these different skin layers.

Published
2024

16. Mindfulness and Imagery Enhanced Behavioural Parent Training: A Natural Evolution in Parenting Interventions

Author

Donovan, Mark O and Donovan, Mark O

Abstract

Many parents feel overwhelmed by challenging child behaviours and multiple demands and seek assistance from parenting interventions. Behavioural parent training (BPT) has represented the gold standard treatment since the 1970s. However, half of parents disengage from BPT, with higher drop-out among socially-disadvantaged families. There is a need for evolution. The five studies within this thesis used a mixed methods approach to examine whether integrating mindfulness and imagery into existing BPT programs, via the 8-week Confident Carers Cooperative Kids (CCCK) group program, could meet a wider sociodemographic of family needs.

Published
2023

18. Centre domination and party competition : Christian Democratic Party strategy in Italy, 1943-89

Author

Donovan, Mark

Subjects
324.245
Abstract

The powerful hold of the Italian Christian Democratic Party on post-war government entitles it to recognition as, in many ways, the most successful party in Western Europe. At the same time, the party is unique in having mass support whilst being identified with the political 'centre'. This study focuses on the relationship between these two aspects of Italian politics. The thesis starts by examining the importance of spatial terminology in analyses of Italian politics and proposes that 'the centre' has two distinct, if not unrelated, meanings. Drawing on this idea the thesis seeks to show that the evolution of the Italian party system can be understood through an analysis of two strategies which have dominated the Christian Democratic Party: the centre political strategy and the centre party strategy, each rooted in a different understanding of the centre. In studying these strategies, party competition is emphasised as the means by which Italian multi-partism has been bound into a unified, if internally contradictory system; whilst a study of economic policy-making exemplifies the complex inter-relationship which has seen this 'contradictory unity' contribute to the nation-building process. The thesis contributes to the debate about the nature of Christian Democracy and party competition in Italy, and to the debate within comparative politics about the nature of party system structure.

Published
1991

27. Honor in Failure

Author

Donovan, Mark and Donovan, Mark

Abstract

As part of the National Collegiate Honors Council’s (2022) collection of essays about the value of honors to its graduates (1967–2019), the author reflects on the personal and professional impacts of the honors experience. I checked the spreadsheet in front of me again, frantically hoping by some grace or magic that the fifth entry I reviewed would somehow erase my mistake. I couldn’t have possibly scrambled more than 1,000 application records, could I have? I poured through the files I had meticulously, even reverently saved over the last weeks. I searched, each click more desperate than its sister before it. Surely, one of these manilla-colored folders held redemption in its electronic depths. Lined up like soldiers at parade, each offered hope, anticipation, sharp anguish as its contents failed to yield the file that would allow me to unmake my terrible transgression. At long last, the inexpungible fact of my blunder had to be faced. I steeled myself, gathering what courage I could muster, and knocked on our director’s door. My eyes traced an agonied, defeated course along the floor before I wrestled my gaze to his face. Still, it took a moment before my mouth decided to speak. “Sir, I may have accidentally messed up the database.” The kindly mouth smiled. Eyes twinkled and the beginnings of crow’s feet at their corners deepened ever so slightly

Published
2022

30. The Catalyst Project: Supporting Faculty Uses of the Web...with the Web.

Author

Donovan, Mark and Macklin, Scott

Abstract

Describes the Catalyst project, an effort at the University of Washington to provide faculty using technology with instruction at the point of need via a Web-based suite of services developed by the university's "Uwired" Center for Teaching, Learning, and Technology. Emphasis is on reaching pragmatists, who comprise the majority of faculty, rather than early adopters of technology. (DB)

Published
1999

34. The Marriott Foundation's 'Bridges...from School to Work' Program--A Framework for Successful Employment Outcomes for People with Disabilities.

Author

Donovan, Mark R. and Tilson, George P.

Abstract

The Marriott Foundation's "Bridges" program is a transitional model designed to help people with disabilities find employment by matching skills with employer needs and creating a welcoming environment. Competitive paid work experience has a significant effect on vocational outcomes, and lasting relationships grow from complementary needs. (SK)

Published
1998

36. Mind the Family: Acceptability and Outcomes for a Mindfulness- and Imagery-Enhanced Behavioral Parenting Program.

Author

Donovan, Mark O., Barkus, Emma, Pickard, Judy A., Konza, Greg, and Herbert, Jane S.

Subjects
*EDUCATION of parents, *MINDFULNESS, *EVALUATION of medical care, *WELL-being, *PARENTING education, *EVALUATION of human services programs, *EFFECT sizes (Statistics), *PSYCHOLOGY of mothers, *FAMILIES, *MENTAL health, *CHILD behavior, *BEHAVIOR, *RESEARCH funding, *PARENT-child relationships, *VISUALIZATION, *PSYCHOLOGY of fathers, *COGNITIVE therapy
Abstract

Enhanced parenting programs aim to meet broader family needs. Past research shows mixed effects for standard programs across differing family characteristics. We evaluate pre- to post-intervention improvements for fathers (n = 115) and mothers (n = 223) of children aged 3 to 12 years with externalizing behaviors who participated in an 8-week mindfulness- and imagery-enhanced behavioral parenting group program. Parents reported high acceptability and significant pre- to post-intervention improvements, with large effect sizes, in parent well-being, parenting approach, mindful parenting, and child behavior. Fathers attended the same number of sessions as mothers and demonstrated similar improvements. Blending imagery and mindfulness with behavioral skills appears helpful, including for fathers. [ABSTRACT FROM AUTHOR]

Published
2023
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47. 'I EXPECTED THE FIRST WEEK TO BE CRAZY'

Author

Donovan, Mark

Abstract

I am feeling alright post-Tour. I'm pretty knackered, but it's nice to have got it done, nice to be finished. However, I've got a hard three weeks behind me now. [...]

Published
2021

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