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7. Safety, tolerability, pharmacokinetics and pharmacodynamics of the oral cyclin-dependent kinase inhibitor AZD5438 when administered at intermittent and continuous dosing schedules in patients with advanced solid tumours

Author

Boss, D. S., Schwartz, G. K., Middleton, M. R., Amakye, D. D., Swaisland, H., Midgley, R. S., Ranson, M., Danson, S., Calvert, H., Plummer, R., Morris, C., Carvajal, R. D., Chirieac, L. R., Schellens, J. H., and Shapiro, G. I.

Published
2010
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9. The CHESS trial: protocol for the process evaluation of a randomised trial of an education and self-management intervention for people with chronic headache

Author

Nichols, VP, Ellard, DR, Griffiths, FE, Underwood, M, Taylor, SJC, Patel, S, Bright, M, Carnes, D, Davies, B, Eldridge, S, Ellard, D, Evans, S, Griffiths, F, Haywood, K, Hee, SW, Matharu, M, Petrou, S, Pincus, T, Sandhu, H, Taylor, S, Wilkie, A, Higgins, H, Nichols, V, Potter, R, Boss, D, White, K, Achana, F, Mistry, H, Caldwell, F, Probyn, K, and Team, CHESS

Subjects
Health Knowledge, Attitudes, Practice, medicine.medical_specialty, Time Factors, Headache Disorders, Health Behavior, Psychological intervention, Medicine (miscellaneous), Process evaluation, law.invention, Study Protocol, 03 medical and health sciences, 0302 clinical medicine, Chronic Migraine, Patient Education as Topic, Randomized controlled trial, law, Chronic tension type headache and medication overuse headache, Self-management, Humans, Medicine, Pharmacology (medical), Active listening, 030212 general & internal medicine, Competence (human resources), Randomized Controlled Trials as Topic, Chronic migraine, lcsh:R5-920, business.industry, Process Assessment, Health Care, Attendance, Treatment Outcome, England, Physical therapy, Chronic headache, Headaches, medicine.symptom, business, lcsh:Medicine (General), 030217 neurology & neurosurgery
Abstract

Background Process evaluation is increasingly common alongside complex randomised controlled trials (RCTs). This evaluation helps in understanding the mechanisms of impact and how the study processes were executed, and it includes any contextual factors which may have implications for the trial results and any future implementation. This process evaluation is for the Chronic Headache Education and Self-management Study (CHESS) RCT, which is evaluating an education and self-management group behavioural intervention for people with chronic headache. Chronic headache is defined as headaches which are present for 15 or more days per month. The most common types are chronic migraine and chronic tension type and medication overuse headaches. Methods We will use a mixed methods approach. Quantitative data will be taken from routine trial data which will help us to assess the reach of the study; i.e. did we reach those whom we expected and from where? Intervention attendance (dose received) and attrition and qualitative data will augment our understanding about reasons why people may not wish to take part in or failed to attend sessions. Interviews with intervention facilitators and trial participants will gain different perspectives on taking part in the trial. Fidelity will be assessed through listening to audio recordings for adherence to course content and competence of the facilitation of a sample of sessions. Discussion Our process evaluation will allow us to gain insight into how the trial was delivered, the obstacles and enablers encountered and the possible reasons why the interventions may or may not be effective. Trial registration ISRCTN79708100. Registered on 16 December 2015. Electronic supplementary material The online version of this article (10.1186/s13063-019-3372-x) contains supplementary material, which is available to authorized users.

Published
2019

10. Relationship between terrain use and performance of beef cows grazing foothill rangeland

Author

Bailey, D. W., Kress, D. D., Anderson, D. C., Boss, D. L., and Miller, E. T.

Subjects
Cows -- Food and nutrition, Grazing -- Analysis, Hereford cattle -- Food and nutrition, Zoology and wildlife conservation
Abstract

A study was conducted on foothills rangeland to determine whether grazing patterns differed among cow breeds and to determine whether there was a relationship between individual grazing patterns and performance of beef cows. Hereford (HH), Tarentaise (TT), 3/4 Hereford x 1/4 Tarentaise (3H1T), 1/2 Hereford x 1/2 Tarentaise (HT), and 1/4 Hereford x 3/4 Tarentaise (1H3T) cows were observed during the summers of 1997 (n = 183) and 1998 (n = 159). Locations of individual cows were recorded two to three times per week during 1.5- to 2.5-h periods in the morning by observers on horseback. Statistical models included cow breed, age, and nursing status. Data from each year were analyzed separately. During 1997 and 1998, nonlactating cows were located at greater (P [is less than] 0.05) vertical distances from water than lactating cows. In 1998, nonlactating cows used steeper (P [is less than] 0.05) slopes than lactating cows. However, nonlactating cows did not travel as far horizontally from water (P [is less than] 0.05) as lactating cows in 1997. Younger cows (3 yr) traveled further (P [is less than] 0.05) from water both vertically and horizontally than older cows (5+ yr) in 1997, but not during 1998. Tarentaise and 1H3T cows were observed at greater (P [is less than] 0.05) vertical distances from water than HH cows during both years of the study. During 1998, TT and 1H3T cows used steeper (P [is less than] 0.05) slopes than HH cows. Using residual correlations, there were no consistent relationships between topographic aspects of individual grazing locations and cow weight, height, and body condition score. In 1997, cows with earlier calving dates and correspondingly heavier calf weaning weights used areas that had greater vertical distances to water; however, in 1998 there were no relationships (P [is greater than] 0.05) of calving date and weaning weight with cow location. During both years, pregnant and nonpregnant cows used terrain similarly (P [is greater than] 0.05), which suggests that cow reproductive performance was not related to terrain use. Grazing patterns in foothills rangeland varied among cow breeds. Performance of cows that used more rugged topography was similar to cows using gentler terrain. Key Words: Cattle, Distribution, Grazing, Lactation, Performance, Weaning Weight

Published
2001

11. Phase i and pharmacological trial of lapatinib in combination with gemcitabine in patients with advanced breast cancer

Author

Pharmacoepidemiology and Clinical Pharmacology, Sub Clinical Pharmacology, Van Der Noll, R., Smit, W. M., Wymenga, A. N M, Boss, D. S., Grob, M., Huitema, A. D R, Rosing, H., Tibben, M. M., Keessen, M., Rehorst, H., Beijnen, J. H., Schellens, J. H M, Pharmacoepidemiology and Clinical Pharmacology, Sub Clinical Pharmacology, Van Der Noll, R., Smit, W. M., Wymenga, A. N M, Boss, D. S., Grob, M., Huitema, A. D R, Rosing, H., Tibben, M. M., Keessen, M., Rehorst, H., Beijnen, J. H., and Schellens, J. H M

Published
2015

16. Phase I and pharmacological trial of lapatinib in combination with gemcitabine in patients with advanced breast cancer.

Author

Noll, R., Smit, W., Wymenga, A., Boss, D., Grob, M., Huitema, A., Rosing, H., Tibben, M., Keessen, M., Rehorst, H., Beijnen, J., and Schellens, J.

Subjects
PROTEIN-tyrosine kinase inhibitors, THERAPEUTIC use of antimetabolites, ACADEMIC medical centers, BREAST tumors, COMBINATION drug therapy, DRUG side effects, LONGITUDINAL method, SAFETY, DESCRIPTIVE statistics, THERAPEUTICS
Published
2015
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25. Registration of ‘Willow Creek’ Forage Wheat

Author

Cash, S. D., primary, Bruckner, P. L., additional, Wichman, D. M., additional, Kephart, K. D., additional, Berg, J. E., additional, Hybner, R., additional, Hafla, A. N., additional, Surber, L. M. M., additional, Boss, D. L., additional, Carlson, G. R., additional, Eckhoff, J. L., additional, Stougaard, R. N., additional, Kushnak, G. D., additional, and Riveland, N. R., additional

Published
2009
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27. AZD2281 (KU-0059436), a PARP (poly ADP-ribose polymerase) inhibitor with single agent anticancer activity in patients with BRCA deficient ovarian cancer: Results from a phase I study

Author

Fong, P. C., primary, Boss, D. S., additional, Carden, C. P., additional, Roelvink, M., additional, De Greve, J., additional, Gourley, C. M., additional, Carmichael, J., additional, De Bono, J. S., additional, Schellens, J. H., additional, and Kaye, S. B., additional

Published
2008
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30. First-in-human study of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PF-00299804, a small molecule irreversible panHER inhibitor in patients with advanced cancer

Author

Schellens, J. H., primary, Britten, C. D., additional, Camidge, D. R., additional, Boss, D., additional, Wong, S., additional, Diab, S., additional, Guo, F., additional, Maguire, R. P., additional, Letrent, S. P., additional, and Eckhardt, S. G., additional

Published
2007
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31. First in human phase I pharmacokinetic (PK) and pharmacodynamic (PD) study of KU-0059436 (Ku), a small molecule inhibitor of poly ADP-ribose polymerase (PARP) in cancer patients (p), including BRCA1/2 mutation carriers

Author

Yap, T. A., primary, Boss, D. S., additional, Fong, P. C., additional, Roelvink, M., additional, Tutt, A., additional, Carmichael, J., additional, O’Connor, M. J., additional, Kaye, S. B., additional, Schellens, J. H., additional, and de Bono, J. S., additional

Published
2007
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45. Improvement and application of the biocontrol fungus Stagonospora convolvuliLA39formulation for efficient control of Calystegia sepiumand Convolvulus arvensis

Author

Boss, D., Schläpfer, E., Fuchs, J., Défago, G., and Maurhofer, M.

Abstract

Field bindweed (Convolvulus arvensis) and hedge bindweed (Calystegia sepium) are noxious perennial weeds which can only partially be controlled by chemical or mechanical methods. Therefore biological control as an alternative is of increasing public and commercial interest. In this study we show that a mycoherbicide based on the fungus Stagonospora convolvuliLA39 efficiently controls bindweed infestations in three noncrop field trials conducted at different locations in two different years. It was the aim of this study to optimize the application strategy of the mycoherbicide regarding number and date of applications, as well as the application rate. It could be shown that conidia of LA39 should be applied two to five times from the beginning of May to the beginning of July, depending on the size and density of bindweed infestation. For an efficient bindweed control the mycoherbicide has to be applied at 40–160 ml m−2and 5 × 106conidia ml−1. Since pathogenic fungi often lose their aggressiveness upon continuous in vitrosubcultivation, the influence of subcultivation on the virulence of LA39 was monitored over 30 vegetative generations. LA39 lost aggressiveness against both bindweed species between the third and the ninth vegetative generation. However, virulence of the fungus was fully restored after a single host plant contact. Thus continuous subcultivation should be avoided when using LA39 as a biocontrol agent. In conclusion, the mycoherbicide LA39 is a promising product to control field and hedge bindweeds; it is a safe alternative to chemical herbicides with regard to product toxicity and environmental impact. Ackerwinden (Convolvulus arvensis) und Zaunwinden (Calystegia sepium) sind schädliche, mehrjährige Unkräuter, welche mit chemischen und mechanischen Mitteln nur bedingt kontrolliert werden können. Das Interesse der Öffentlichkeit an Alternativen wie der biologischen Kontrolle nimmt zu, auch in kommerzieller Hinsicht. Wie in dieser Studie anhand dreier Feldversuche gezeigt werden konnte, ist ein auf dem Pilz Stagonospora convolvuliLA39 basierendes Mykoherbizid in der Lage, Windenbewuchs wirksam zu bekämpfen. Diese Versuche wurden an drei verschiedenen Orten und in zwei verschiedenen Jahren durchgeführt. Ziel der Studie war die Anwendung des Mykoherbizides bezüglich Anzahl und Zeitpunkt der Applikationen als auch der Applikationsmenge zu optimieren. Es konnte gezeigt werden, dass die LA39-Konidien je nach Dichte des Windenbewuchses zwei bis fünfmal zwischen Anfang Mai und Anfang Juli appliziert werden müssen. Um die Winden nachhaltig zu bekämpfen muss das Mykoherbizid mit einer Sporenkonzentration von 5 × 106Konidien ml−1und 40–160 ml m−2angewendet werden. Da pilzliche Pathogene bei längerdauernder in vitroKultivierung bekanntermassen oft ihre Pathogenität verlieren, wurde der Einfluss einer solchen Subkultivierung über 30 vegetative Generationen hinweg untersucht. Die Aggressivität von LA39 gegenüber beiden Windenarten ging bereits zwischen der dritten und der neunten Generation verloren. Seine Virulenz konnte aber mittels eines einzigen Wirtspflanzenkontaktes vollständig regeneriert werden. Wird LA39 als Produktionsstamm genützt, so soll möglichst auf eine fortlaufende in-vitro-Kultivierung verzichtet werden. Zusammenfassend kann festgestellt werden, dass das Mykoherbizid LA39 ein viel versprechendes Produkt darstellt, welches auf Grund seiner guten Umweltverträglichkeit eine sichere Alternative zur chemischen Kontrolle der Zaun- und Ackerwinde ist.

Published
2007
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49. Reevaluation of the disulfiram-alcohol reaction in man.

Author

Sauter, A M, Boss, D, and von Wartburg, J P

Abstract

The intensity of the disulfiram-alcohol reaction is found to depend on the blood acetaldehyde level, a disulfiram-induced predisposition reflected by alkalosis, and an individual predisposition reflected by dopamine-beta-hydroxylase activity.

Published
1977
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