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Book
Leadership and management of clinical trials in creative arts therapy
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ISBN: 3031180844 3031180852 Year: 2022 Publisher: Cham, Switzerland : Palgrave Macmillan,

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Book
Clinical Trials In Parkinson's Disease
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ISBN: 1071609122 1071609114 Year: 2021 Publisher: New York, NY : Springer US : Imprint: Humana,

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This volume looks at major clinical trials for motor and non-motor symptoms in Parkinson’s Disease (PD) and covers important aspects, including trial design, sample selection, and outcome selection. Chapters in this book discuss topics such as toxin-based rodent or genetic models of PD; clinical trials for motor symptoms, L-DOPA related motor complications, and gait disorders; clinical trials for mood disorders, troubled sleep, autonomic dysfunction; and clinical trials for disease modifying therapies. In the Neuromethods series style, chapters include the kind of detail and key advice from the specialists needed to get successful results in your laboratory or research center. Cutting-edge and authoritative, Clinical Trials in Parkinson’s Disease is a valuable resource for clinicians and researchers who want to enhance their interpretation of results from clinical trials and to design their own high-quality trials. .


Book
Analysis of data from randomized controlled trials : a practical guide
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ISBN: 3030818659 3030818640 Year: 2021 Publisher: Cham, Switzerland : Springer,


Book
Principles and practice of clinical trials
Authors: ---
ISBN: 3319526367 Year: 2022 Publisher: Cham, Switzerland : Springer,

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This is a comprehensive major reference work for our SpringerReference program covering clinical trials. Although the core of the Work will focus on the design, analysis, and interpretation of scientific data from clinical trials, a broad spectrum of clinical trial application areas will be covered in detail. This is an important time to develop such a Work, as drug safety and efficacy emphasizes the Clinical Trials process. Because of an immense and growing international disease burden, pharmaceutical and biotechnology companies continue to develop new drugs. Clinical trials have also become extremely globalized in the past 15 years, with over 225,000 international trials ongoing at this point in time.


Book
Real-World Evidence in Medical Product Development
Authors: --- ---
ISBN: 3031263286 3031263278 Year: 2023 Publisher: Cham : Springer International Publishing : Imprint: Springer,

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This book provides state-of-art statistical methodologies, practical considerations from regulators and sponsors, logistics, and real use cases for practitioners for the uptake of RWE/D. Randomized clinical trials have been the gold standard for the evaluation of efficacy and safety of medical products. However, the cost, duration, practicality, and limited generalizability have incentivized many to look for alternative ways to optimize drug development. This book provides a comprehensive list of topics together to include all aspects with the uptake of RWE/D, including, but not limited to, applications in regulatory and non-regulatory settings, causal inference methodologies, organization and infrastructure considerations, logistic challenges, and practical use cases.


Book
Fundamentals of clinical trials
Authors: --- --- --- ---
ISBN: 3319185381 331918539X Year: 2015 Publisher: Cham : Springer International Publishing : Imprint: Springer,

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This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals. The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives. Although a basic introductory statistics course is helpful in maximizing the benefit of this book, a researcher or practitioner with limited statistical background would still find most if not all the chapters understandable and helpful. While the technical material has been kept to a minimum, the statistician may still find the principles and fundamentals presented in this text useful. This book has been successfully used for teaching courses in clinical trial methodology. .


Book
Pre-Clinical and Clinical Methods in Brain Trauma Research
Authors: ---
ISBN: 1493985647 1493985639 Year: 2018 Publisher: New York, NY : Springer New York : Imprint: Humana,

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This volume explores current viewpoints and knowledge gaps in the field of traumatic brain injury (TBI). The chapters in this book cover topics ranging from development of in vitro and animal TBI models, to diagnostic imaging and disease monitoring in patients. Designing pre-clinical and clinical trials is also discussed. In Neuromethods series style, chapters include the kind of detail and key advice from the specialists needed to get successful results in your laboratory. Practical and thorough, Pre-Clinical and Clinical Methods in Brain Trauma Research is a valuable resource for both scientists and clinical researchers interested in learning about important techniques and their applications in the field of TBI.


Book
Bayesian adaptive design for immunotherapy and targeted therapy
Authors: ---
ISBN: 9811981760 9811981744 Year: 2023 Publisher: Singapore : Springer Nature Singapore : Imprint: Springer,

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This book provides a comprehensive review of novel adaptive trial designs for targeted therapies and immunotherapies. This book covers a wide range of novel statistical designs for various clinical settings, including early phase dose-escalation study, proof-of-concept trials, and confirmatory studies with registrational. The book includes real-life examples and software to facilitate practitioners to learn and use the designs in practice.


Book
Challenging Assumptions Around Dementia : User-led Research and Untold Stories
Authors: --- --- --- --- --- et al.
ISBN: 3031272234 3031272226 Year: 2023 Publisher: Cham : Springer International Publishing : Imprint: Palgrave Macmillan,

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This open access book explores the expectations surrounding dementia, what it ‘looks like’ and how people have been treated by others. It aims to raise awareness of the different types of dementia, and how they impact the brain, body, and lived experience, including experience of Alzheimer’s disease, Vascular Dementia, Posterior Cortical Atrophy, Frontotemporal Dementia, Semantic Dementia, and Lewy Body Dementia. The co-authors reflect on their experience with informal and formal care, before finishing with a focus on the spectrum of dementia research from clinical trials to user-led research. Throughout the book, co-authors have shared personal stories of how dementia has affected them and people with lived experience of dementia share what they wish people knew about living with the disease. Co-produced by people with lived experience of dementia, academics and health care professionals, this book is an accessible resource about dementia from the perspective of people actively involved in the field and essential reading for healthcare professionals wishing to learn more about the experience of this neuroprogressive condition, as well as policymakers, and members of the public. Dr Rosie Ashworth leads Partners in Research for NRS Neuroprogressive and Dementia Network, UK. As a research psychologist, Rosie is passionate about co-production, ethics, and actively involving people with lived experience in research. She is also the co-lead for ENRICH Scotlands ‘Patient and Public Involvement’ group RICH (Research in Care Homes) Voices, a Fellow with Advanced Higher Education, an advisor to the Dementia Enquirers, and a volunteer for About Dementia. Partners in Research co-authors including Agnes Houston, Chris Maddocks, David Ross, Fred S. Wilson, Masood Qureshi, Martin Robertson, Myra Lamont, Stuart Hay, Sue Fyvel, Willy Gilder, Winnie Henry, and Alyson Hill.


Book
Management of Cardiac Arrhythmias
Authors: --- ---
ISBN: 3030419673 3030419665 Year: 2020 Publisher: Cham : Springer International Publishing : Imprint: Humana,

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A significantly expanded third edition, this book provides a comprehensive and concise overview of cardiac arrhythmias and their ECG/telemetry manifestations, including the principles of cardiac electrophysiology, current concepts of pharmacology, clinical features, diagnoses, and state-of-the-art treatments. Additionally, the book emphasizes decision-making strategies in approaching each individual patient and the application of technical innovations in specific clinical situations. Organized into eight parts, beginning chapters introduce the concepts and principles of cardiac electrophysiology, unique rhythms, and ECG waves/signs. These chapters are designed to integrate emerging knowledge in basic science and clinical medicine. Subsequent chapters focus on the diagnosis of a variety of cardiac arrhythmias using non-invasive methodology. Throughout the book, chapters continue to analyze pharmacological and other approaches to therapy of specific arrhythmias, including supraventricular tachycardias, atrial fibrillation and flutter, ventricular arrhythmias, and bradyarrhythmias. Finally, the book closes with coverage on inherited cardiac arrhythmia syndromes including the long, short QT, and J-wave syndromes, catecholaminergic polymorphic ventricular tachycardia, and arrhythmogenic right ventricular cardiomyopathy. The third edition of Management of Cardiac Arrhythmias, is an essential resource for physicians, residents, fellows, and medical students in cardiology, cardiac surgery, vascular surgery, cardiac electrophysiology, and cardiac radiology.

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