Medical research Books

Book SynopsisSo You Want to Be a Scientist offers readers a glimpse into the job of being a research scientist. It is not intended to be a step-by-step how to book. Rather, it is intended to fill a hole in the education of most would-be scientists, addressing explicitly many issues that are rarely addressed directly in training programs. Starting with thoughts about how to decide whether you''d want to pursue such a career (and if so, how to get started), the book works through some of the obvious topics relevant to a research profession (e.g. how to write a paper, give a talk, construct a grant proposal). It also examines less obvious, but equally important topics that are generally incorporated into a research education only by trial and error-e.g., thinking like a scientist, negotiating scientific politics, dealing with research ethics, and understanding social interactions. Chapters on the challenges and rewards of a career in research science include reflections on science as art and on the soTrade Review"There are too few good books about the positives and negatives of research careers in science, books aimed at young people who need to make choices in high school or college or even in graduate school. Philip A. Schwartzkroin, a neurosurgeon who specializes in epilepsy research, has written such a book. His book has something for everyone from high school through graduate school. His focus is a career in research, and nearly everything he says is equally applicable to careers in all the basic and applied sciences. It's a readable book, and I cannot imagine anyone interested in a career in science not finding it enormously useful."--Dan Agin, as reviewed in The Huffington Post "The author is a professor in the Department of Neurological Surgery at the University of California, Davis. Here, he offers 'an invaluable glimpse into the day-to-day life of the researcher' and gives advice on deciding 'whether you'd want to pursue such a career (and, if so, how to get started.'"--As featured in the "What's New in Sciences books section of Scibook.org and Science Book News "If you're a confused college student, still grasping for some direction in your life, you may have considered a career in research at some point. It's a little daunting to think about, being such a broad field, but Philip Schwartzkroin's helpful book, So You Want to Be a Scientist? makes it surprisingly navigable. Schwartzkroin has obviously experienced what students are going through; his clear and entertaining narrative outlines the whole process, from applying to grad school to working in a faculty position. He explains the challenges and opportunities students will encounter at every step of the journey, and provides advice and encouragement along the way."--As reviewed in The Observer, the student newspaper of Case Western University So You Want to Be a Scientist?...is intended as an introduction to the job of a research scientist. The intended audience is a student in college or high school who is contemplating such a career. However, even graduate students and post-doctoral fellows may also benefit from the perspective of a highly successful scientist who has trained and mentored many people...Dr. Schwartzkroin offers many insights and suggestions and discusses issues that, although obvious to most researchers, many young students may not have contemplated or even be aware of....While it is only a single person's viewpoint, the book is unbiased and general enough to be useful to almost anyone contemplating or starting a career as a research scientist. Readers will find this book useful for focusing their own thoughts and perceptions about research, and, hopefully, helping them to make some decisions regarding their personal path."--Saurabh R. Sinha, MD, PhD, as reviewed in Epilepsy & Behavior "...a crisp new book that should be on the reading list for all young scientists, Philip Schwartzkroin, a Professor of Neuroscience at the University of California Davis, rolls up his sleeves and quickly dispenses with this fairy tale notion of science in which the lone genius dreams up brilliant ideas that change the world. He lays bare the challenges that young scientists will face and the compromises that they may have to make...That the author can engage in these discussions without detracting from the big, beautiful ideas that draw people into science in the first place is a testament to his skill as a writer and mentor...We live in a time of enormous potential for scientific research, but which often feels plagued by a raging epidemic of angst about science as a career. Schwartzkroin's book, combined with a deeper appreciation of the extended value of a PhD, could be a much-needed antidote."--Reviewed by John E. Spiro in Nature NeuroscienceTable of ContentsIntroduction ; 1. Getting Started ; 2. Career Choices and Laboratory Nitty-Gritty ; 3. How to Think like a Scientist ; 4. How to Write a Scientific Paper ; 5. Giving Presentations and Talks ; 6. How to Compose/Submit Grant Applications ; 7. The Politics of Science ; 8. Ethical Conduct of Research ; 9. Scientific Research as a Creative Enterprise ; 10. The Role of the Scientist in Society ; 11. Personal Challenges ; 12. Rewards and Riches

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Book SynopsisThe Human Use of Animals presents case studies that look at the practical and ethical issues arising from the human use of animals. The case studies report the facts about some of the most compelling and difficult issues that confront society today in the human use of animals. Each case study combines the facts of the case with analysis of ethical issues.Table of ContentsPART I. INTRODUCTION; PART II. FARM ANIMALS; PART III. ANIMALS FOR ENTERTAINMENT; PART IV. COMPANION ANIMALS; PART V. RELIGIOUS USES OF ANIMALS; PART VI. ENDANGERED SPECIES; PART VII. BIOMEDICAL RESEARCH AND COSMETIC TESTING; PART VIII. BEHAVIORAL RESEARCH; PART IX. WILDLIFE RESEARCH; PART X. EDUCATIONAL USES OF ANIMALS

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Book SynopsisEvery year, hundreds of millions of animals are used in the service of biomedical research, despite the risk of extreme cruelty to these animal subjects. The expansion of the pharmaceutical industry and university research funding rapidly normalized its practice. What exactly are these experiments supposed to achieve from the scientific point of view and how effective are they? Working scientists answer these questions by saying that their research is absolutely necessary if we are to develop new therapies for human diseases. But is this really the case? Written by a scientist with over 40 years of laboratory experience, The Rise and Fall of Animal Experimentation critically examines this assumption and asks whether it is true that animal-based research achieves its aims and, if so, how often this occurs and if there are alternatives to performing animal-based science. The book takes readers through the history of animal experimentation: its early beginnings in antiquity, how it advancTable of ContentsPrologue: The Seminar Chapter 1: Greek Awakenings Chapter 2: Circular Arguments Chapter 3: Mapping Humanity Chapter 4: Fear and Trembling Chapter 5: The Modern Prometheus Chapter 6: I Want to be Your Dog Chapter 7: Not Just Kids Chapter 8: The Cloud Cap'd Towers Bibliography Index

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Book SynopsisGenetic Counseling Research: A Practical Guide is the first text devoted to research methodology in genetic counseling. This text offers step-by-step guidance for conducting research, from the development of a question to the publication of findings. Genetic counseling examples, user-friendly worksheets, and practical tips guide readers through the research and publication processes.With a highly accessible, pedagogical approach, this book will help promote quality research by genetic counselors and research supervisors--and in turn, increase the knowledge base for genetic counseling practice, other aspects of genetic counseling service delivery, and professional education. It will be an invaluable resource to the next generation of genetic counseling and its surrounding disciplines.Trade ReviewThe authors have done an excellent job with this manual of scientific methodology oriented to genetic counselors... The value of this book lies in the simplicity of its presentation and its usefulness to beginning genetic counselors who plan to embark on research and scientific writing. * Doody's Notes *Table of ContentsPreface ; Chapter 1: Developing Research Questions ; Chapter 2: Finding Sources ; Chapter 3: Writing a Review of Literature ; Chapter 4: Ethics in Research ; Chapter 5: Choosing a Paradigm ; Chapter 6: Designing a Quantitative Study ; Chapter 7: Quantitative Data Analysis: I've got data, how do I get answers? ; Chapter 8: Conducting Qualitative Genetic Counseling Research ; Chapter 9: Preparing a Manuscript for Publication ; Chapter 10: Guidelines for Directing Research ; References ; Appendix: Additional Resources for Researchers and Research Supervisors

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Book SynopsisDrugs like Lipitor, Plavix, Taxol, and Zoloft are integral in today''s medicinal world. These widely used products save lives and improve the quality of lives, playing a crucial role in everything from cholesterol management to cancer treatment. These advances in medicine were brought into existence after nuanced process of creation, featuring a wide range of chemical and pharmacological experimentation and discovery.Top Drugs: Their History, Pharmacology, and Synthesis provides an in-depth study on ten prominent drugs, outlining the chemistry behind each one''s creation. Jie Jack Li, a medicinal chemist and an expert on drug discovery, offers a thorough analysis of the landscape of current drug development. The comprehensive text is divided by health issues, including cardiovascular, cancer, metabolic diseases, and infectious diseases. Each section features individual chapters on significant drugs, outlining the chemistry and history of the drug''s discovery. Li begins each chapter wiTrade Review"This book will interest students and scientists in disciplines such as chemistry, biology, pharmacology, toxicology, clinical medicine, and biotechnology, as well as informed general audiences. Recommended." --CHOICETable of ContentsTable of Contents ; CARDIOVASCULAR DRUGS ; Chapter 1 Atorvastatin Calcium (Lipitor) ; Chapter 2 Clopidogrel (Plavix) ; Chapter 3 Amlodipine (Novasc) ; CANCER DRUGS ; Chapter 4 Paclitaxel (Taxol) ; Chapter 5 Imatinib (Gleevec) ; DRUGS FOR METABOLIC DISEASES ; Chapter 6 Sitagliptin (Januvia) ; CNS DRUGS ; Chapter 7 Sertraline (Cymbalta) ; Chapter 8 Olanzapine (Zyprexa) ; DRUGS TO TREAT INFECTIOUS DISEASES ; Chapter 9 Sofosbuvir (Sovaldi) ; ULCER DRUGS ; Chapter 10 Esomeprazole (Nexium)

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Book SynopsisMolecular understanding of cancer and cancer progression is at the forefront of many research programs today. High-throughput array technologies and other modern molecular techniques produce a wealth of molecular data about the structure, and function of cells, tissues, and organisms. Correctly analyzed and interpreted these data hold the promise of bringing new markers for prognostic and diagnostic use, for new treatment schemes, and of gaining new biological insight into the evolution of cancer and its molecular, pathological, and clinical consequences.Aimed at graduates and researchers, this book discusses novel advances in informatics and statistics in molecular cancer research. Through eight chapters from carefully chosen experts it brings the reader up to date with specific topics in cancer research, how the topics give rise to development of new informatics and statistics tools, and how the tools can be applied. The focus of the book is to give the reader an understanding of keyTable of ContentsPREFACE ; 1. Association Studies ; 2. Methods for DNA Copy Number Derivations ; 3. Methods for Derivation of LOH and Allelic Copy Numbers Using SNP Arrays ; 4. Bioinformatics of gene expression and copy number data integration ; 5. Analysis of DNA Methylation in Cancer ; 6. Pathway Analysis: Pathway Signatures and Classification ; 7. Two Methods for Comparing Genomic Data Across Independent Studies in Cancer Research: Meta-analysis and Oncomine Concepts Map ; 8. Bioinformatic Approaches to the Analysis of Alternative Splicing Variants in Cancer Biology ; INDEX

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Book SynopsisThe Oxford Textbook of Clinical Research Ethics is the first comprehensive and systematic reference on clinical research ethics. Under the editorship of experts from the U.S. National Institutes of Health of the United States, the book''s 73 chapters offer a wide-ranging and systematic examination of all aspects of research with human beings.Considering the historical triumphs of research as well as its tragedies, the textbook provides a framework for analyzing the ethical aspects of research studies with human beings. Through both conceptual analysis and systematic reviews of empirical data, the contributors examine issues ranging from scientific validity, fair subject selection, risk benefit ratio, independent review, and informed consent to focused consideration of international research ethics, conflicts of interests, and other aspects of responsible conduct of research.The editors of The Oxford Textbook of Clinical Research Ethics offer a work that critically assesses and advancesTrade Review"The Oxford Textbook of Clinical Research Ethics is the most comprehensive work on this broad topic to date. It sets a high bar for clinical research writing of any kind and, for that matter, textbooks of any kind...It presents thoughtful analyses of each topic by authorities in the field." --The Journal of Clinical Research Best Practices "Overall, the authors have achieved their goals--comprehensiveness, systematic analysis and wide ranging and international perspectives--providing a valuable resource for all those interested and involved in research. For occupational health professionals, it is a book that should be accessible on the library shelf." --Occupational MedicineTable of ContentsPart. 1: The History of Research with Humans; 1. Walter Reed and the Yellow Fever Experiments 2. The Nazi Medical Experiments 3. The Imperial Japanese Experiments in China 4. The Randomized Controlled Trial of Streptomycin 5. The Salk Polio Vaccine Field Trial of 1954 6. The Jewish Chronic Disease Hospital Case 7. The Hepatitis Experiments at the Willowbrook State School 8. The Tuskegee Syphilis Experiment 9. HIV Research 10. The Gelsinger Case 11. An Ethical Framework for Biomedical Research ; Part 2: Codes, Declarations, and Other Ethical Guidance for Research with Humans; 12. The Nuremberg Code 13. The Declaration of Helsinki 14. The Belmont Report 15. Regulations for the Protection 16. International Ethical Guidance from the Council for International Organizations of Medical Sciences 17. The Council of Europe 18. The European Community Directives on Data Protection and Clinical Trials 19. National Bioethics Commissions and Research ; Part 3: Context, Purpose, and Value of Clinical Research ; 20. Exploitation in Clinical Research 21. The Nature, Scope, and Justification of Clinical research: What is Research? Who is a Subject? 22. Four Paradigms of Clinical Research and Research Oversight 23. The Role of Patient Advocates and Public Representatives in Research ; Part 4: ; Scientific Design ; 24. Equipoise and Randomization 25. The Ethics of Placebo- Controlled Trials 26. Challenge Experiments 27. Emergency Research 28. Consent for Research with Biological Samples 29. Genetic Diagnostic, Pedigree, and Screening Research 30. Deception in Clinical Research 31. Ethics of Epidemiology: Observational Studies on Human Populations 32. Ethical Issues in Behavioral and Social Science Research 33. Phase 1 Oncology Research 34. Surgical Innovation and Research ; Part 5: Participant Selection ; 35. What is Fair in Participant Selection? 36. Incentives for Research Participants 37. Ethical Issues in Recruiting Research Participants 38. Ethical Issues in Research Involving Women 39. Ethical Issues in Research with Ethnic and Minority Populations 40. Research Involving Economically Disadvantaged Participants 41. Research Involving Those at Risk for Impaired Decision-making Capacity 42. Research with Children 43. Captive Populations: Prisoners, Students, and Soldiers 44. Research with Identifiable and Targeted Communities 45. Research with Health Volunteers 46. Research with Fetuses, Embryos, and Stem Cells ; Part 6: Risk-Benefit Assessments ; 47. Risk-Benefit Analysis and the Net Risks Test 48. Assessing the Comparing Potential Benefits and Risks of Harm 49. Risk-Benefit Assessment in Pediatric Research ; Part 7: Independent Review and Oversight ; 50. Institutional Review Boards: Their Origins and the Policies that Govern Them 51. Models of Institutional Review Board Function 52. Assessing and Comparing Potential Benefits and Risks of Harm 53. Data and Safety Monitoring Boards 54. The Food and drug Administration and Drug Development: Historic, Scientific, and Ethical Considerations ; Part 8: Informed Consent ; 55. A History of Informed Consent in Clinical Research 56. Philosophical Justifications of Informed Consent in Research 57. Legal and Regulatory Standards of Informed Consent in Research 58. The Therapeutic Misconception 59. Empirical Issues in Informed Consent for Research 60. The Assent Requirement in Pediatric Research ; Part 9: Respect for Human Research Participants ; 61. Confidentiality 62. Legal Responsibility to Research Subjects: Liability and Compensation for Injury 63. The Obligation to Ensure Standards ; Part 10 Multi-National Research ; 64. Appropriate Standards 65. Benefits to Host Countries 66. The Standard of Care in Multi-National Research 67. Responsiveness to Host Community Health Needs ; Part 11: Clinical Investigator Behavior ; 68. Conflicts of Interest in Medical Research: historical Developments 69. Conflicts of Interest 70. Empirical Data on Obligations of Publication: Authorship and Dissemination ; Index

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Book SynopsisHow the NIH Can Help You Get Funded takes a novel, non-formulaic approach in teaching readers how to write a grant -- and much more. The authors draw on their decades of experience working with both investigators and NIH personnel to anticipate their questions and concerns and help establish a comfortable, productive partnership between them. With this book''s focus on applying this knowledge to their personal grant strategy, readers will learn: how the NIH operates at the corporate level, as well as the culture and policies of individual institutes and centers how the NIH budget evolves over the course of a fiscal year and why the timing is important how to customize NIH Web site searches and use the data to increase chances of success how to identify appropriate program officers, study sections, and funding opportunitiesThe authors advise readers on developing each component of the grant application in order of the components'' influence on the final impact score. Individual funding mechanisms are reviewed along with grantsmanship tips specific to each. Readers learn the importance of reviewer-friendly formatting and organization of the text.The final chapters cover next steps after the application has been submitted-before, during, and after the review and funding decision. Strategies for resubmitting or repurposing applications are provided for those readers whose applications do not receive awards. The authors likewise anticipate the needs of readers who do receive funding but have questions on managing and maintaining their award.Amid ever-increasing competition for government research grants, How the NIH Can Help You Get Funded is an invaluable manual for how to pursue -- and sustain -- NIH funding.Trade ReviewThe two authors are experienced with and knowledgeable about this bureaucratic system and provide researchers an exceptional aid in working through the process...the authors do a magnificent job of explaining why the application process is so time-intense. The book also gives superb advice about developing a protocol and applying for a grant and what the different decision steps mean for researchers.100 - 5 stars! * Doody's Notes *Table of ContentsTable of Contents ; Foreword ; Preface ; Acknowledgments ; Essential Steps for Securing NIH Funding: A Quick Guide to Key Concepts ; Abbreviations ; Chapter 1: National Institutes of Health ; * Overview of agency organization and activities ; * Congressional authorization and appropriations ; * Office of the Director components and oversight ; * Overview of grant application and award process, including timeline over three fiscal years ; Chapter 2: Institutes and Centers ; * Overview of each institute and center, with a common data set for each (key links, contact information, details on how funding decisions are made) ; * Advisory Council role ; * Funding trend data where available (number of applications scored and funded at each percentile for FY12 and in some cases FY11) ; Chapter 3: Center for Scientific Review and the Peer Review Process ; * Overview of CSR and its activities ; * Application referral to an IC and study section ; * Picking the right reviewers ; * How your application is reviewed (in person and on the Internet) ; * Tips for crafting your application to help the reviewers ; * How your application is scored and what the score means ; * How percentiles are calculated and the difference between percentile, payline, and success rate ; * Becoming a reviewer ; Chapter 4: Office of Extramural Research ; * Overview of OER and its activities ; * Finding and understanding funding opportunities ; * Preparing the application package ; * Overview of eRA Commons ; * Overview of NIH grants policy ; Chapter 5: Federal Budget Process ; * Impact of federal budget status on NIH funding decisions ; * Process of proposing and passing the federal budget (and NIH appropriation) ; * How you can advocate for more NIH funding ; * What ICs do once they have their final appropriation ; Chapter 6: NIH Funding Data and Trends ; * Overview of available funding data ; * Change in success rate by R01 application type and submission (FY03, FY12) ; * Using NIH data to enhance your grant strategy ; Chapter 7: Getting at Mechanism ; * Overview of NIH funding mechanisms ; * Research grants (R) ; * Small business research project grant mechanisms ; * Research programs (P) ; * Career development (K) ; * Research training (F, T) ; * Supplements and bridge funding ; Chapter 8: Telling Your Story Well ; * Overview of developing your proposal, including where to put preliminary data ; * Correlation between individual criterion scores and impact score ; * Specific aims ; * Approach ; * Significance ; * Innovation ; * Introduction ; * Protection of research subjects ; * Project summary (abstract) ; * Investigators and environment ; * Cover letter ; * Budget ; Chapter 9: Presenting Your Message Well ; * Organizing your ideas in parallel with review process ; * Reader-friendly formatting tips ; * Science of communicating (rhetoric) ; * Videos in NIH applications ; Chapter 10: Getting by with a Little Help from Your Friends ; * Interacting with POs (tips and etiquette) ; * Importance of having others read your narrative ; Chapter 11: Before and After the Review ; * Interacting with the SRO before the review ; * What to expect the week your application is reviewed ; * When and how to interact with your PO after the review ; * Council actions after the review ; * Why appeals are rarely a good idea (and what to do when one is warranted) ; * Administrative review of the application and award processing ; Chapter 12: Is the Check in the Mail? ; * Understanding what your score and, if included, percentile mean ; * Timing of payline setting and funding decisions ; * Interacting with your PO ; Chapter 13: The Check is Not in the Mail ; * Next-steps if your application was not discussed or did not make the paylist ; * Strategies for resubmission ; * Timing of resubmission ; * Whether to change study sections ; * Repurposing your application ; * Long-term grant application strategy ; Chapter 14: The Check is in the Mail, BUT ; * Reduction in budget and/or number of years ; * If you relocate to another institution ; * Carrying funds over from one FY to the next and no-cost extensions ; * Compliance with NIH Public Access Policy required for non-competing renewal and citing NIH support in manuscripts ; Appendix A ; Index

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Book SynopsisIn the 1960s, University of Cincinnati radiologist Eugene Saenger infamously conducted human experiments on patients with advanced cancer to examine how total body radiation could treat the disease. Using the Saenger case as a means to reconsider cold war medical trials, this book examines the tensions at the heart of clinical studies of the time.Trade Review"What is truly original about Contested Medicine is that, by using the science studies approach applied to a specific historical case, Kutcher shows not only how ethics were constitutive of the shape of experimental work on cancer at its inception but how both of these things were mutually changed over time." - Christopher Lawrence, Wellcome Trust Centre for the History of Medicine, University College London"

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Book SynopsisTrade Review"You might think that museums are for collecting and laboratories for experimenting. Bruno J. Strasser tracks the creation of a hybrid culture--a 'way of knowing' that was comparative and experimental at the same time. Molecular biologists used the protein sequences of very various species to crack the genetic code. From bacteria to blood and protein to DNA, this engaging book restores collecting to the experimentalist tradition and gives 'big data' biology the history it needs."--Nick Hopwood, author of Haeckel's Embryos: Images, Evolution, and Fraud "Amidst all the hype surrounding Big Data and the life sciences, Bruno J. Strasser uncovers the deep continuities of collecting and comparing that link the latest data banks to venerable natural history museums. This bold book rethinks the relationship between field, laboratory, and archive, with important implications for the ethos of open publication in science."--Lorraine Daston, Max Planck Institute for the History of Science "The long-contested line between experimental life sciences and those that collect, compare, and classify is once more unsettled. It is now accepted that comparative sciences are open to experiment and always have been. And Bruno J. Strasser now argues that the celebrated achievements of experimental biology have similarly depended on practices of collecting and curating. And not just in our own new world of digital databases, but historically: from when experimenters first thought to make collecting forever obsolete. Strasser supports his bold revision with case studies of a broad range of sciences, from taxonomy to serology, experimental and then molecular biology, and bio-informatics. In its historical depth and breadth this is a benchmark book; and for all who want to know how life sciences really work, it's a must read."--Robert E. Kohler, University of Pennsylvania "A masterful, groundbreaking work: Strasser explores collecting activities in multiple branches of biology and medicine across several centuries, covering the territory from natural historical specimens to blood and proteins, and on to DNA sequences and contemporary big-data biology. His book assesses issues of lasting salience, including control of the collections, access to specimens and data, modes of publication, and assignment of authorship and credit. Strasser contends that big-data biology is not a sharp departure from the past but a hybrid, a joining of the experimentalist-reductionist inquiries into model organisms with the practices of collectors who classified and characterized their specimens and compared them with others. Strasser's research is wide and deep, his prose lucidly informative, and his analysis subtle, discerning, and persuasive." --Daniel J. Kevles, Yale University "Collecting Experiments is an exciting and welcome addition to the historiography of the long-standing debates about the changing roles of experimentation and description in the life sciences. Rejecting the older notion of an impassable dichotomy, Bruno J. Strasser suggests that the rise of experimental approaches to biology in the nineteenth century did not eclipse the more descriptive work of natural history, but rather became a part of an overall 'way of knowing' that included both approaches. 'Big data, ' whether obtained by experimental or observational methods had to be analyzed in the same manner. Strasser has done a great service to clarify the historical relationship between these two methodologies. It is a must for all scholars in the history of biology."--Garland Allen, Washington University in Saint Louis

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Book SynopsisKenneth F. Schaffner compares the practice of biological and medical research and shows how traditional topics in philosophy of sciencesuch as the nature of theories and of explanationcan illuminate the life sciences. While Schaffner pays some attention to the conceptual questions of evolutionary biology, his chief focus is on the examples that immunology, human genetics, neuroscience, and internal medicine provide for examinations of the way scientists develop, examine, test, and apply theories. Although traditional philosophy of science has regarded scientific discoverythe questions of creativity in scienceas a subject for psychological rather than philosophical study, Schaffner argues that recent work in cognitive science and artificial intelligence enables researchers to rationally analyze the nature of discovery. As a philosopher of science who holds an M.D., he has examined biomedical work from the inside and uses detailed examples from the entire range of the life sciences to support the semantic approach to scientific theories, addressing whether there are laws in the life sciences as there are in the physical sciences. Schaffner's novel use of philosophical tools to deal with scientific research in all of its complexity provides a distinctive angle on basic questions of scientific evaluation and explanation.

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Book SynopsisAlthough the subject of federally mandated Institutional Review Boards (IRBs) has been extensively debated, we actually do not know much about what takes place when they convene. This book melds observations of IRB meetings with the history of how rules for the treatment of human subjects were formalized in the United States.Trade Review"Behind Closed Doors is a novel and important addition to the literature on the governance of experimentation on human subjects. It will appeal to academic scholars in the history of science and medicine, sociology, bioethics, and postwar American history." (Gerald Kutcher, author of Contested Medicine: Cancer Research and the Military)"

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Book SynopsisAlthough the subject of federally mandated Institutional Review Boards (IRBs) has been extensively debated, we actually do not know much about what takes place when they convene. This book melds observations of IRB meetings with the history of how rules for the treatment of human subjects were formalized in the United States.Trade Review"Behind Closed Doors is a novel and important addition to the literature on the governance of experimentation on human subjects. It will appeal to academic scholars in the history of science and medicine, sociology, bioethics, and postwar American history." (Gerald Kutcher, author of Contested Medicine: Cancer Research and the Military)"

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Book SynopsisTable of ContentsTranslating Medicine, ca. 800–1900: Articulations and Disarticulations Tara Alberts, Sietske Fransen, and Elaine LeongTranslation and the Making of a Medical Archive: The Case of the Islamic Translation Movement Ahmed RagabUnveiling Nature: Liu Zhi’s Translation of Arabo-Persian Physiology in Early Modern China Dror WeilNew World Drugs and the Archive of Practice: Translating Nicolás Monardes in Early Modern Europe Alisha RankinWhen the Tallamys Met John French: Translating, Printing, and Reading The Art of Distillation Elaine LeongVernacular Languages and Invisible Labor in Ṭibb Shireen HamzaWhere There’s Smoke, There’s Fire: Pyric Technologies and African Pipes in the Early Modern World Benjamin BreenTranslating the Inner Landscape: Anatomical Bricolage in Early Modern Japan Daniel TrambaioloCasting Blood Circulations: Translatability and Braiding Sciences in Colonial Bengal Projit Bihari MukharjiFemale Authority in Translation: Medieval Catalan Texts on Women’s Health Montserrat Cabré[Un]Muffled Histories: Translating Bodily Practices in the Early Modern Caribbean Pablo F. GómezTranslating Surgery and Alchemy between Seventeenth-Century Europe and Siam Tara Alberts“Use Me as Your Test!”: Patients, Practitioners, and the Commensurability of Virtue Hansun HsiungNotes on Contributors Index

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Book SynopsisThis book opens readers' eyes to the enormous resources of the Earth's rain forests and the potential impact of their destruction in terms of human health.

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Book SynopsisTrade ReviewJonathan Kahn's approach offers an airtight analysis of the commoditization of race in pharmaceutical development, and Race in a Bottle should be of interest and deep concern to numerous audiences. -- Ruha Benjamin, Boston University Jonathan Kahn has produced a major and unique contribution, giving readers a 'big picture' understanding of this vital issue by integrating empirically grounded analysis of real controversies into a detailed conceptual roadmap. This is a substantial piece of scholarship and will be of interest to anyone concerned with the escalating, even geometrically expanding use of the concept of race in science and medicine. -- Troy Duster, University of California, Berkeley Jonathan Kahn is the undisputed Hercules Poirot of biomedicine. His unraveling of the nonsense, non-science, and complicated illogic that allowed the vasodilator BiDil to be approved by the FDA exclusively for 'black' patients is as compelling a read as any good mystery. This riveting book details what happens to scientific method when profit motive drives the marketing of a drug to the extent that its curative properties are touted as race-specific-even when they're not. Genetic variation in humans has no correlation to the shifting historical meanings of race, yet pharmaceutical companies continue to force the square peg of social category into the round hole of scientific fact. Race in a Bottle is a brilliant deconstruction of the kinds of thought processes that make for bad policy, bad medicine, and ultimately endanger our health as a species. -- Patricia Williams, Columbia Law School Jonathan Kahn brilliantly exposes the stunning truth behind new race-based medicines: they are driven by market incentives, not scientific evidence. Based on meticulous research and astute analysis, Kahn constructs a gripping, devastating portrait of profit motivating the use of race in genetic research and pharmaceuticals. Race in a Bottle is absolutely essential for understanding why the myth of biological race has reemerged in genomic science and biotechnology and how it is distorting research, damaging pubic health, and undermining justice in our supposedly post-racial society. -- Dorothy Roberts, author of Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-first Century Kahn expertly weaves together the legal and ethical ramifications of continuing to pursue racialized drugs... No background in health sciences or genetics is necessary to understand this work. Library Journal [Race in a Bottle] tackle[s] one of the most important concerns pertaining to race facing our society today... Must-read material. New Scientist An extraordinary book... I highly recommend it. -- Osagie Obasogie BioPolitical Times Mr. Kahn deserves credit for teasing out all the daunting complexities behind these events, including the details of genetic analysis, the perils of racial determinations, and the minutiae of patent law. -- Abigail Zuger, M.D. New York Times Kahn's book should be required reading. At a time when the ties between scientific researchers and the pharmaceutical industry are becoming ever more entangled, Race in a Bottle provides valuable insights into the consequences of these connections for health and health care - and, importantly, for what passes as knowledge. -- Lundy Braun GeneWatch A powerful saga packed with engrossing twists and turns of plot and filled with food for thought and debate on the politics and health implications of racial perception. Midwest Book Review Finely crafted and written. -- Alejandra Suarez PsycCritiques [Kahn] seems as much at home discussing epidemiology and drug marketing as he does the history of US race relations and the intricacies of patenting... Magnificent. -- Dr. Martyn Pickersgill The Biologist A compelling account of a fascinating case. -- Anne Pollock Bulletin of the History of Medicine Race in a Bottle is lucid and energetic, with fascinating and little-known evidence about clinical trials, the federal regulatory and patent systems, and the history of racial classification... Kahn offers a heartfelt and persuasive case against allowing race to be reduced to biology. -- Jennifer L. Hochschild Journal of American History [Kahn] skillfully uses the story of the drug BiDil... as the backdrop for examining the expanding role of race in medical genomics, even when the same science has called the existence of race into serious doubt. -- Aravinda Chakravarti Nature Medicine Highly recommended. Choice [Jonathan Kahn's] rich portrayal of the changing meaning and uses of race in the wake of genomics makes this book a 'must read' and 'must assign' for all sociologists of race and ethnicity. Sociology of Race and EthnicityTable of ContentsAcknowledgments INTRODUCTION: Race and Medicine: Framing [Is] the Problem 1. ORGANIZING RACE: Paths Toward the Re-Biologization of Race in Modern Biomedical Research, Practice, and Product Development 2. THE BIRTH OF BIDIL: How a Drug Becomes "Ethnic" 3. STATISTICAL MISCHIEF AND RACIAL FRAMES FOR DRUG DEVELOPMENT AND MARKETING 4. CAPITALIZING [ON] RACE IN DRUG DEVELOPMENT 5. RACE-ING PATENTS/PATENTING RACE: An Emerging Political Geography of Intellectual Property in Biotechnology 6. NOT FADE AWAY: The Persistence of Race and the Politics of the "Meantime" in Pharmacogenomics 7. FROM DISPARITY TO DIFFERENCE: The Politics of Racial Medicine CONCLUSIONS AND RECOMMENDATIONS Notes Index

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Book SynopsisTrade ReviewJonathan Kahn's approach offers an airtight analysis of the commoditization of race in pharmaceutical development, and Race in a Bottle should be of interest and deep concern to numerous audiences. -- Ruha Benjamin, Boston University Jonathan Kahn has produced a major and unique contribution, giving readers a 'big picture' understanding of this vital issue by integrating empirically grounded analysis of real controversies into a detailed conceptual roadmap. This is a substantial piece of scholarship and will be of interest to anyone concerned with the escalating, even geometrically expanding use of the concept of race in science and medicine. -- Troy Duster, University of California, Berkeley Jonathan Kahn is the undisputed Hercules Poirot of biomedicine. His unraveling of the nonsense, non-science, and complicated illogic that allowed the vasodilator BiDil to be approved by the FDA exclusively for 'black' patients is as compelling a read as any good mystery. This riveting book details what happens to scientific method when profit motive drives the marketing of a drug to the extent that its curative properties are touted as race-specific-even when they're not. Genetic variation in humans has no correlation to the shifting historical meanings of race, yet pharmaceutical companies continue to force the square peg of social category into the round hole of scientific fact. Race in a Bottle is a brilliant deconstruction of the kinds of thought processes that make for bad policy, bad medicine, and ultimately endanger our health as a species. -- Patricia Williams, Columbia Law School Jonathan Kahn brilliantly exposes the stunning truth behind new race-based medicines: they are driven by market incentives, not scientific evidence. Based on meticulous research and astute analysis, Kahn constructs a gripping, devastating portrait of profit motivating the use of race in genetic research and pharmaceuticals. Race in a Bottle is absolutely essential for understanding why the myth of biological race has reemerged in genomic science and biotechnology and how it is distorting research, damaging pubic health, and undermining justice in our supposedly post-racial society. -- Dorothy Roberts, author of Fatal Invention: How Science, Politics, and Big Business Re-create Race in the Twenty-first Century Kahn expertly weaves together the legal and ethical ramifications of continuing to pursue racialized drugs... No background in health sciences or genetics is necessary to understand this work. Library Journal [Race in a Bottle] tackle[s] one of the most important concerns pertaining to race facing our society today... Must-read material. New Scientist An extraordinary book... I highly recommend it. -- Osagie Obasogie BioPolitical Times Mr. Kahn deserves credit for teasing out all the daunting complexities behind these events, including the details of genetic analysis, the perils of racial determinations, and the minutiae of patent law. -- Abigail Zuger, M.D. New York Times Kahn's book should be required reading. At a time when the ties between scientific researchers and the pharmaceutical industry are becoming ever more entangled, Race in a Bottle provides valuable insights into the consequences of these connections for health and health care - and, importantly, for what passes as knowledge. -- Lundy Braun GeneWatch A powerful saga packed with engrossing twists and turns of plot and filled with food for thought and debate on the politics and health implications of racial perception. Midwest Book Review Finely crafted and written. -- Alejandra Suarez PsycCritiques [Kahn] seems as much at home discussing epidemiology and drug marketing as he does the history of US race relations and the intricacies of patenting... Magnificent. -- Dr. Martyn Pickersgill The Biologist A compelling account of a fascinating case. -- Anne Pollock Bulletin of the History of Medicine Race in a Bottle is lucid and energetic, with fascinating and little-known evidence about clinical trials, the federal regulatory and patent systems, and the history of racial classification... Kahn offers a heartfelt and persuasive case against allowing race to be reduced to biology. -- Jennifer L. Hochschild Journal of American History [Kahn] skillfully uses the story of the drug BiDil... as the backdrop for examining the expanding role of race in medical genomics, even when the same science has called the existence of race into serious doubt. -- Aravinda Chakravarti Nature Medicine Highly recommended. Choice [Jonathan Kahn's] rich portrayal of the changing meaning and uses of race in the wake of genomics makes this book a 'must read' and 'must assign' for all sociologists of race and ethnicity. Sociology of Race and EthnicityTable of ContentsAcknowledgments INTRODUCTION: Race and Medicine: Framing [Is] the Problem 1. ORGANIZING RACE: Paths Toward the Re-Biologization of Race in Modern Biomedical Research, Practice, and Product Development 2. THE BIRTH OF BIDIL: How a Drug Becomes "Ethnic" 3. STATISTICAL MISCHIEF AND RACIAL FRAMES FOR DRUG DEVELOPMENT AND MARKETING 4. CAPITALIZING [ON] RACE IN DRUG DEVELOPMENT 5. RACE-ING PATENTS/PATENTING RACE: An Emerging Political Geography of Intellectual Property in Biotechnology 6. NOT FADE AWAY: The Persistence of Race and the Politics of the "Meantime" in Pharmacogenomics 7. FROM DISPARITY TO DIFFERENCE: The Politics of Racial Medicine CONCLUSIONS AND RECOMMENDATIONS Notes Index

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Book SynopsisA discussion of the diagnosis of breast cancer and the risks, benefits and limitations of treatment alternatives, particularly tamoxifen. This edition contains information on developments in the use of tamoxifen, especially in the results of the Breast Cancer Prevention Trial.

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Book SynopsisTable of ContentsPart 1 Conceptual Framework 1. The definition of precision medicine in neurodegenerative disorders and the one disease-many-diseases tension 2. Models of precision medicine for neurodegeneration 3. Pathology vs pathogenesis: Rationale and pitfalls in the clinicopathology model of neurodegeneration 4. Mixed pathology as a rule, not exception: Time to reconsider disease nosology? 5. Neurodegenerative disorders: From clinicopathology convergence to systems biology divergence 6. The emergence of genotypic divergence and future precision medicine applications 7. Lessons from other fields of medicine, Part 1: Breast cancer 8. Lessons from other fields of medicine, Part 2: Cystic fibrosis 9. Lessons learned from evolving frameworks in adult glioblastoma Part 2 Pitfalls in Definitions, Cohorts, and Measures of Progression 10. Finding the falsification threshold of the toxic proteinopathy hypothesis in neurodegeneration 11. The theoretical problems of “prodrome” and “phenoconversion” in neurodegeneration 12. The dilemma between milestones of progression vs. clinical scales in Parkinson disease 13. Biomarkers of diagnosis, prognosis, pathogenesis, response to therapy: Convergence or divergence? Lessons from Alzheimer Disease and synucleinopathies 14. Challenges in the study of individuals at risk for Parkinson disease 15. The challenging quest of neuroimaging: From clinical to molecular-based subtyping of Parkinson disease and atypical parkinsonisms

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Book SynopsisTable of ContentsPart 3 Basic Science Development 1. Role of rodent models in advancing precision medicine for Parkinson disease 2. The allure and pitfalls of the prion-like aggregation in neurodegeneration 3. The shift to a proteinopenia paradigm in neurodegeneration 4. Disease mechanisms as subtypes: Lysosomal dysfunction in the endolysosomal Parkinson disease subtype 5. Disease mechanisms as subtypes: Mitochondrial and bioenergetic dysfunction 6. Disease mechanisms as subtypes: Immune dysfunction in Parkinson disease 7. Disease mechanisms as subtypes: Inflammation in Parkinson disease and related disorders 8. Disease mechanisms as subtypes: Microbiome 9. LRRK2: Genetic mechanisms vs genetic subtypes 10. Genetic mechanism vs genetic subtypes: The example of GBA 11. Subtyping monogenic disorders: Huntington disease Part 4 Clinical Trials and Therapeutic Approaches 12. Disease-modifying vs symptomatic treatments: splitting over lumping 13. Restorative cell and gene therapies for Parkinson disease 14. The promise and challenges of extracellular vesicles in the diagnosis of neurodegenerative diseases 15. Therapeutic potential of extracellular vesicles in neurodegenerative disorders 16. Lessons from antiamyloid-ß immunotherapies in Alzheimer disease 17. Lessons from immunotherapies in multiple sclerosis 18. Adaptive clinical trials and master protocols 19. Role of novel endpoints and evaluations of response in Parkinson Disease 20. Leveraging the regulatory framework to facilitate drug development in Parkinson disease

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Book SynopsisTable of ContentsSection I. Assessment of the respiratory system in neurological disorders 1. Pulmonary function testing in neuromuscular disease 2. Electrophysiological assessment of respiratory function Section II. Primary breathing disorders 3. Apnea of prematurity and sudden infant death syndrome 4. Developmental diseases affecting the respiratory system: CCHS and ROHHAD 5. Central sleep apnea 6. Obstructive sleep apnea Section III. Neurological disorders affecting respiration 7. Breathing disturbances in Rett syndrome 8. Sudden unexpected death in epilepsy: Respiratory mechanisms 9. Multiple Sclerosis and related disorders 10. Stroke and breathing 11. Breathing disorders in neurodegenerative diseases 12. Spinal cord injury and degenerative cervical myelopathy 13. Motor neuron, peripheral nerve, and neuromuscular junction disorders 14. Phrenic nerve paralysis and phrenic nerve reconstruction surgery Section IV. Cardiovascular disorders affecting respiration 15. Sleep and breathing disorders in heart failure 16. Neurological effects of respiratory dysfunction 17. Neurologic complications of coronavirus and other respiratory viral infections Section V. Treatment considerations for respiratory dysfunction in neurological disorders 18. Noninvasive and invasive mechanical ventilation for neurologic disorders

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Book SynopsisTable of Contents1. Respiratory rhythm and pattern generation: Brainstem cellular and circuit mechanisms 2. Central respiratory chemoreception 3. Neurobiology of the carotid body 4. Adaptive cardiorespiratory changes to chronic continuous and intermittent hypoxia 5. Early development of the breathing network 6. Critical roles for breathing in the genesis and modulation of emotional states 7. Breathing during sleep 8. The physiology and pathophysiology of exercise hyperpnea 9. Regulation of breathing by cardiopulmonary afferents 10. Respiratory-cardiovascular interactions 11. Dyspnea 12. The pathophysiology of opioid-induced respiratory depression 13. The sigh and related behaviors 14. Neural control of the lower airways: Role in cough and airway inflammatory disease 15. The phrenic neuromuscular system 16. Respiratory neuroplasticity: Mechanisms and translational implications of phrenic motor plasticity

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Book SynopsisTable of Contents1. Segmental Spinal Cord Syndromes 2. Spinal Muscular Atrophy 3. Syringomyelia and Chiari malformations 4. Hereditary Spastic Paraplegia 5. Primary lateral Sclerosis 6. Transverse Myelitis in Children and Adults 7. Progressive Spinal MS 8. Tropical Spastic Paraparesis 9. Cerebellar Ataxias 10. Bowel, Bladder and Sexual Disorders 11. Motor System Consequences of Mild Traumatic Brain Injury 12. The Synucleinopathies 13. The Tauopathies 14. Genetic and Sporadic ALS 15. Paraneoplastic Motor Disorders 16. Non-Neoplastic Neuronal Autoantibody Encephalitides 17. Pediatric Post-Infectious Encephalopathies 18. Motor Sequela of Dementia 19. Motor Seizure Semiology 20. Motor Sequela of Stroke 21. Adult and Childhood Hydrocephalus 22. Cortical and Subcortical Visual Motor System Disorders 23. Essential Tremor 24. Primary and Secondary Dystonia 25. Frontal and Prefrontal Lobe Motor Syndromes 26. Parietal Lobe Motor Syndromes 27. Applied Strategies of Neuroplasticity 28. Treatment of Spasticity 29. Human-Robotics: Brain Computer Interface 30. Neural Tissue Transplantation 31. Botulinum Toxin for Motor Disorders 32. Tau Based Passive Immunotherapy

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Book SynopsisReal-world evidence (RWE) has been at the forefront of pharmaceutical innovations. It plays an important role in transforming drug development from a process aimed at meeting regulatory expectations to an operating model that leverages data from disparate sources to aid business, regulatory, and healthcare decision making. Despite its many benefits, there is no single book systematically covering the latest development in the field.Written specifically for pharmaceutical practitioners, Real-World Evidence in Drug Development and Evaluation, presents a wide range of RWE applications throughout the lifecycle of drug product development. With contributions from experienced researchers in the pharmaceutical industry, the book discusses at length RWE opportunities, challenges, and solutions.Features Provides the first book and a single source of information on RWE in drug development Covers a broad array of topics on outTable of Contents1 Using Real-world Evidence to Transform Drug Development: Opportunities and Challenges. 2. Evidence derived from real world data: utility, constraints and cautions. 3. Real-World Evidence from Population-Based Cancer Registry Data. 4. External Control using RWE and Historical Data in Clinical Development. 5. Bayesian method for assessing drug safety using real-world evidence. 6. Real-World Evidence for Coverage and Payment Decisions. 7. Causal Inference for Observational Studies/Real-World Data. 8. Introduction to Artificial Intelligence and Deep Learning with a Case Study in Analyzing Electronic Health Records for Drug Development.

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Book SynopsisThe second volume in the CURRENT TOPICS IN NONCLINICAL DRUG DEVELOPMENT SERIES explores the critical issues and current topics in nonclinical drug development. This second volume covers individual topics and strategies in drug development from compound characterization to drug registration. Written by a variety of experts in the field, recent and rapid advances in technologies and associated changes in regulatory guidance are discussed.Select topics include: Evolution of Artificial Intelligence (AI) technologies and the impact on toxicologic pathology. Current approaches to carcinogenicity testing. Predicting drug-drug interactions. Current understanding of idiosyncratic drug reaction. Assessing cardiovascular risks beyond QT interval. Use of 3D cell cultures in toxicology and ADME. Development of small molecule-antibody complexes. Differentiating adverse from non-adverse findings in nonclinical studiesTable of Contents1. Introduction and History of Digital Toxicologic Pathology 2. Carcinogenicity Testing of Human Pharmaceuticals 3. Differentiating Adverse and Non-adverse Findings in Nonclinical Studies 4. Current Understanding of Idiosyncratic Drug Reactions 5. Three-Dimensional Cell Culture Models in Toxicology and ADME 6. Assessing Cardiovascular Risk Beyond the hERG Channel and the QT Interval 7. Fundamentals of Drug-Drug Interactions 8. Development of Small Molecule-Antibody Complexes

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Book SynopsisMeta-analysis is the application of statistics to combine results from multiple studies and draw appropriate inferences. Its use and importance have exploded over the last 25 years as the need for a robust evidence base has become clear in many scientific areas, including medicine and health, social sciences, education, psychology, ecology, and economics.Recent years have seen an explosion of methods for handling complexities in meta-analysis, including explained and unexplained heterogeneity between studies, publication bias, and sparse data. At the same time, meta-analysis has been extended beyond simple two-group comparisons of continuous and binary outcomes to comparing and ranking the outcomes from multiple groups, to complex observational studies, to assessing heterogeneity of effects, and to survival and multivariate outcomes. Many of these methods are statistically complex and are tailored to specific types of data.Key featuresRigorous coverage of tTrade Review"Handbook of Meta-Analysis is a most laudable and detailed treatise on meta-analysis. It successfully covers – with gusto and substance – the full range of statistical methodology used in meta-analysis in a statistically rigorous and up-to-date manner, exuding a good balance of theory and applications (with real data and software syntax provided). It provides a comprehensive, coherent, and unified overview of the statistical foundations behind meta-analysis. Crafted by experts on the topic, each chapter is written with lucidity and surgical precision. It is elegantly organized, encyclopedic in breadth and depth, and fluent in exposition on the multidimensional role of meta-analysis: core material (background, systematic review process, data extraction, study-level results, frequent and Bayesian approaches); key extensions (meta-regression, individual data, multivariate meta-analysis, network meta-analysis, model checking, bias); and advances in particular fields of biomedical and social research (control risk regression, survival data, correlation matrices, genetic data, dose-response relationships, diagnostic tests, surrogate endpoints, complex observational data, prognostic models). It is a tour de force, a premier, and an indispensable reference that is highly recommended – and a must for serious researchers and practitioners engaged in meta-analysis. This state-of-the-science handbook is destined to be a classic."- Joseph C. Cappelleri, PhD, MPH, MS, Executive Director of Biostatistics, Pfizer Inc "For many researchers in social, medical, life and environmental sciences, it has become an essential part of their activities to synthesize evidence from the body of relevant research. The Handbook of Meta-analysis provides the most comprehensive and up-to-date coverage of the quantitative part of evidence synthesis, i.e., meta-analysis. Therefore, this handbook is a must-have for all researchers who wish to unlock and understand the power and potential of meta-analysis, but also for those who have already found and benefited from it. The authors of this edited volume are an interdisciplinary all-star team of statisticians and methodologists; probably, each of them could have written a textbook on meta-analysis. Here, they introduce both basics and advanced techniques that they have been leading to develop over their career. For many statisticians, a meta-analysis may be just one type of linear models (Chapters 1-11), yet, as this book demonstrates, meta-analyses can come in diverse forms and serve different purposes (see Chapters 14-22). Further, there are specific statistical issues meta-analysis needs to grapple with, such as publication bias (Chapters 12-13). The book ends with a chapter on how to use meta-analysis to plan our future work (Chapter 23) – what all scientists should be doing to reduce research waste and to accelerate scientific progress."- Shinichi Nakagawa, Professor of Evolutionary Biology and Synthesis, University of New South Wales, Sydney, Australia "This is an important book on an important subject, covering both theory and application, and it should be valuable to a wide range of readers in statistics and applied fields."- Andrew Gelman, Columbia University "...The Handbook of Meta-Analyses is a “must have” resource for: 1) statisticians, other professionals, and students conducting statistical research in meta-analysis; 2) practitioners conducting meta-analyses as part of systematic reviews or otherwise; and 3) educators and students who want to either start, or continue, to learn more about meta-analysis. The breadth and depth of up-to-date coverage of meta-analysis methods, wide range of areas of application, and examples, including online software code and data, is impressive. The contents are weighted towards frequentist strategies, but Bayesian strategies are highlighted in the core materials and revisited elsewhere. The Handbook is a pleasure to read. The editors and other co-authors guide the reader in a cohesive, unified fashion, from the foundational core material through increasingly sophisticated and wider ranging methods and applications. Their tone is conversational, with forwards-and-backwards sign-posting which integrates the contents in a tutorial-like fashion. Statistical notation is used with purpose, without excess, while maintaining statistical rigor in content. An abundance of graphs, figures, and tables reinforce the statistical concepts and methods, and visualize the examples. Both novice and more experienced readers will benefit...The Handbook of Meta-Analysis is a significant contribution which provides a palpable opportunity to improve future decision-making and policy setting."- Thomas Bradstreet, Appeared in the Journal of Biopharmaceutical Statistics "The handbook is intended for a relatively wide audience of statisticians, to be used as a textbook in a graduate course, as a reference book, a handbook or an introduction. The first part easily accomplishes these aims. There is a fair number of formulas, but they are well-explained and thus the text should be accessible for any statistician or quantitative researcher." -Anikó Lovik, International Society for Clinical Biostatistics, 72, 2021 Table of Contents1. Introduction to systematic review and meta-analysis2. General themes in meta-analysis3. Choice of effect measure and issues in extracting outcome data4. Analysis of univariate study-level summary data using normal models5. Exact likelihood methods for group-based summaries6. Bayesian methods for meta-analysis7. Meta-regression 8. Individual participant data meta-analysis9. Multivariate meta-analysis10. Network meta-analysis11. Model Checking in meta-analysis12. Handling internal and external biases: quality and relevance of studies13. Publication and outcome reporting bias14. Control risk regression15. Multivariate meta-analysis of survival proportions16. Meta-analysis of correlations, correlation matrices and their functions17. The meta-analysis of genetic studies18. Meta-analysis of dose-response relationships19. Meta-analysis of diagnostic tests20. Meta-analytic approach to evaluation of surrogate endpoints21. Meta-analysis of epidemiological data, with a focus on individual participant data22. Meta-analysis of prediction models23. Using meta-analysis to plan further research

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Book SynopsisDrawing on the knowledge and experiences of world-renowned scientists and healthcare professionals, this important book brings together academic, medical and health systems accounts of the impact of applying qualitative research methods to transform healthcare behaviours, systems and services. It demonstrates the translation of tried-and-tested and new interventions into high-quality care delivery, improved patient pathways, and enhanced systems management. It melds social theory, health systems analysis and research methods to address real-life healthcare issues in a rich and realistic fashion. The systems and services examined include those affecting patient care and patient and professional wellbeing, and the roles and responsibilities of people providing and receiving care. Some chapters delve deeply into the human psyche, examining the very private face of health and illness. Others concentrate on public health and how people's needs can be met through healthTable of ContentsPart 1 Ideas 1.Introduction:Why this book 2.Qualitative Evidence Synthesis and Conceptual Development 3.The Life-Project of personal Wellbeing: Modern Healthcare and the Individuality of Health 4.Socio-Narratology and the Clinical Encounter Between human Beings 5.Interrupted Body Projects and the Narrative Reconstruction of Self 6.The Fourth Research Paradigm: Activating Researchers for Real World Need Part 2 Systems 7.Slack Resources in Healthcare Systems: Waste or Reslilance? 8.Using Qualitative Methods to Understand Resiliance in Complex Systems 10.Narrativising Cancer Patients' Longitudinal Experiences of Care: Qualitative Inquiry into Lived and Online Melanoma Stories 11.Look the Other Way: Patient-Centred Care Begisn with Care for Our Physicians 12.Resilient Healthcare in Refractory Epilepsy: Illuminating Successful People-Centred Care Part 3 Solutions 13.Sensemaking as a Strategy for Managing Uncertainty: Change and Surprise in Hospital Settings 14.Simulation to Solve Health System Problems 15.Cross-Boundary Teaming to Establish Resiliance Among Isolated 'Silos' 16."What on Earth is Going on and What Should I Do Now?" Sensemaking as a Qualitative Process 17.Deep Inside the Genomics Revoltion: On The Frontlines of Care 18.Much More Than Old Wine in New Bottles: Soft Systems Methodology (SSM) for healthcare improvement 19.Conclusion: On progress, directions and signposts to a transformed healthcare system

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Book SynopsisPraise for the Second Edition:â this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study. -BiometricsThis impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered â â Journal of the Royal Statistical SocietySample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, thisTrade ReviewPraise for the Second Edition:"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics"This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered …" – Journal of the Royal Statistical Society"The book is nicely set out with an introduction to the basic idea of each topic, followed by various formulae that lead to power calculations . . . In all, I consider this book to be well written, and it touches on quite a number of more recent topics in sample size determination. Consequently, it will be a useful addition to clinical statisticians as a point of reference to solve more complex issues in power calculations during the design of a clinical trial." – Steve Su, International Society for Clinical BiostatisticsSample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation.Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.Praise for the Second Edition:"… this is a useful, comprehensive compendium of almost every possible sample size formula. The strong organization and carefully defined formulae will aid any researcher designing a study." -Biometrics"This impressive book contains formulae for computing sample size in a wide range of settings. One-sample studies and two-sample comparisons for quantitative, binary, and time-to-event outcomes are covered comprehensively, with separate sample size formulae for testing equality, non-inferiority, and equivalence. Many less familiar topics are also covered …" – Journal of the Royal Statistical Society"The book is nicely set out with an introduction to the basic idea of each topic, followed by various formulae that lead to power calculations . . . In all, I consider this book to be well written, and it touches on quite a number of more recent topics in sample size determination. Consequently, it will be a useful addition to clinical statisticians as a point of reference to solve more complex issues in power calculations during the design of a clinical trial." – Steve Su, International Society for Clinical BiostatisticsSample Size Calculations in Clinical Research, Third Edition presents statistical procedures for performing sample size calculations during various phases of clinical research and development. A comprehensive and unified presentation of statistical concepts and practical applications, this book includes a well-balanced summary of current and emerging clinical issues, regulatory requirements, and recently developed statistical methodologies for sample size calculation.Features: Compares the relative merits and disadvantages of statistical methods for sample size calculations Explains how the formulae and procedures for sample size calculations can be used in a variety of clinical research and development stages Presents real-world examples from several therapeutic areas, including cardiovascular medicine, the central nervous system, anti-infective medicine, oncology, and women’s health Provides sample size calculations for dose response studies, microarray studies, and Bayesian approaches This new edition is updated throughout, includes many new sections, and five new chapters on emerging topics: two stage seamless adaptive designs, cluster randomized trial design, zero-inflated Poisson distribution, clinical trials with extremely low incidence rates, and clinical trial simulation.Table of ContentsIntroduction. Considerations Prior to Sample Size Calculation. Comparing Means. Large Sample Tests for Proportions. Exact Tests for Proportions. Tests for Goodness-of-Fit and Contingency Tables. Comparing Time-to-Event Data. Group Sequential Methods. Comparing Variabilities. Bioequivalence Testing. Dose Resonse Studies. Microarray Studies. Bayesian Sample Size Calculation. Nonparametrics. Cluster Randomized Design. Sample Size Calculation for Two-Stage Adaptive Design. Sample Size for Clinical Trials with Extremely Low Incidence Rates. Clinical Trial Simulation for Sample Size Estimation. Sample Size Calculation in Other Areas.

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Table of Contents1. Introduction.- 1.1. Historical Survey.- 1.2. Dose-Response Curves and Special Aspects of Radiation Action.- 1.3. The Temporal Stages of Radiation Action.- 1.4. The Significance of Molecular Radiation Biology.- 1.5. An Introduction to Molecular Radiation Biology.- References.- 2. The Hit Theory.- 2.1. Basic Concepts.- 2.2. Single and Multiple Hit Phenomena.- 2.3. Dose-Response Curves of Multiple Target Systems.- 2.4. The Influence of Biological Variability on the Form of Dose-Response Curves.- 2.5. The “Relative Steepness” of the Dose-Response Curve.- 2.6. Possibilities of Deception by Single-Hit Curves.- References.- 3. The Stochastics of the Action of Radiation.- 3.1. Kinetic Interpretation of the Dose-Response Curve.- 3.2. Multi-Hit Curves.- 3.3. Reverse Processes.- 3.4. A Formalistic Description of Dose-Response Curves.- 3.5. Dose-Response Curves of Colony Formation.- References.- 4. Primary Processes of Energy Absorption.- 4.1. X- and Gamma-Radiation.- 4.2. Neutrons.- 4.3. Charged Particles.- 4.4. Uptake of Energy by Molecules.- 4.5. The Energy Distribution of Secondary Electrons.- 4.6. Energy Deposited per Primary Interaction.- References.- 5. Target Theory and Action Cross Section.- 5.1. Establishment of a Rigid Concept of a “Hit”.- 5.2. Target Theory.- 5.3. Theory of the Action Cross Section.- 5.4. Relative Biological Effectiveness.- References.- 6. Direct and Indirect Action of Radiation.- 6.1. The Direct Effect.- 6.2. Indirect Effect in Solutions.- 6.3. Indirect Effect in Cells.- 6.4. Indirect Effect in the Dry State.- 6.5. Protective and Sensitizing Agents.- References.- 7. The Temperature Effect.- 7.1. Experimental Observations.- 7.2. Temperature Effect and the Indirect Action of Radiation..- 7.3. LET-Dependence of the Temperature Effect.- 7.4. The “Thermal Spike” Model.- References.- 8. The Oxygen Effect.- 8.1. The Oxygen Effect in Macromolecules.- 8.2. An Oxygen Effect Hypothesis.- 8.3. The Oxygen Effect in Bacteria.- 8.4. Oxygen Effect and LET.- References.- 9. The Action of Radiation on Enzymes: The Example of Ribonuclease.- 9.1. Structure and Function of Ribonuclease.- 9.2. Inactivation Kinetics.- 9.3. Radiation-Induced Radicals.- 9.4. Changes in Irradiated Enzyme Molecules.- 9.5. Separation and Identification of Irradiation Products.- 9.6. Amino Acid Analysis.- 9.7. Mechanisms of Inactivation.- References.- 10. Physico-Chemical Changes in Irradiated Nucleic Acids.- 10.1. The Structure of DNA.- 10.2. Radiation-Induced Radicals.- 10.3. Chemical Changes in Irradiated DNA.- 10.4. Breaks in the Polynucleotide Chains.- 10.5. Intermolecular Cross-Linking.- 10.6. Rupture of Hydrogen Bonds.- References.- 11. Inactivation of Nucleic Acid Functions.- 11.1. Functions of Nucleic Acids.- 11.2. Infectivity.- 11.3. Transformation.- 11.4. Priming Activity of DNA.- 11.5. Enzyme Induction.- 11.6. DNA-mRNA Hybrids.- 11.7. Translation.- References.- 12. The Action of Radiation on Viruses.- 12.1. Basic Properties of Viruses.- 12.2. Inactivation of Viruses containing Single-Stranded Nucleic Acids.- 12.3. Inactivation of Viruses containing Double-Stranded DNA.- 12.4. Repair of Radiation Damage in Viral DNA.- 12.5. BU Effect.- References.- 13. The Action of Radiation on Bacteria.- 13.1. Some Basic Properties of Bacteria.- 13.2. Inactivation of Bacteria.- 13.3. Bacterial DNA as the Critical Target.- 13.4. Repair of UV Damage.- 13.5. Repair of Damage caused by Ionizing Radiation.- 13.6. Genetic Control of Repair in Bacterium E. coli.- 13.7. Micrococcus Radiodurans.- References.- 14. Radiation Sensitivity and Biological Complexity.- 14.1. Attempts at a Systematic Approach.- 14.2. What is Radiation Sensitivity?.- References.

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Book SynopsisKnowledge of the basic mechanisms of human disease is essential for any student or professional engaged in drug research and development. Functional gene analysis (genomics), protein analysis (proteomics), and other molecular biological techniques have made it possible to understand these cellular processes, opening up exciting opportunities for novel therapeutic possibilities.Molecular Pathomechanisms and New Trends in Drug Research presents an in-depth review of the molecular mechanisms involved in a number of common diseases including cancer, AIDS, inflammation, cardiovascular disease and neurodegenerative disorders, with particular emphasis on signal transduction and potential therapeutic strategies. It will be a useful reference text for students and researchers in chemistry, biochemistry, medicine and the pharmaceutical sciences.Table of ContentsIntroduction. Pathomechanisms and Molecular Target Finding. Common Pathway and General Mechanism. Drug Discovery. Molecular Pathomechanism of Cancer. Infectious Diseases. Diseases of the Central and the Peripheral Nervous System. Cardiovascular Diseases. Endocrinal and Gastrointestinal Disorders. Drug Applications.

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Book SynopsisResearching, Reflecting and Writing about Work provides a guide to the research skills and critical thinking required to complete a research project for professional learning courses in counselling and psychotherapy. Written at a level easily accessible to those enrolled on a work-based qualification as well as those considering postgraduate research at master''s level, this book includes: how we reflect on our work discussion on preparation and structuring of a case study how to present work in supervision with advice on process recording essay plan structures and appropriate methodologies for research ethical considerations and critical linking dilemmas and tensions involved in research at work'. Key learning points and reflective exercises are included throughout and theory is supported by contributions detailing specific learning experiences from a variety of work setTrade Review"This is an important book. For the first time the gamut of diverse training programmes for therapists are linked in a systematic and productive way with the research methodologies currently in use." - Rom Harré, from the Preface"By providing examples of the experience of counsellors in pursuing research projects that have meaning and value for their clients and themselves, the contributors to the book are able to show that research can indeed represent a significant means of extending and deepening insight and understanding in ways that are relevant to understanding the purpose and process of therapy, and which enhance rather than undermine the therapeutic relationship." - John McLeod, from the Foreword"Researching, Reflecting and Writing about Work can be dipped into, and chapters hold their own, independtly of the whole. However, the book's true richness comes through best from reading it in full... I highly recommend it, and expect to refer to it often with a range of students." - Sandra Taylor, Healthcare, Counselling and Psychotherapy Journal, July 2010"This is an important book. For the first time the gamut of diverse training programmes for therapists are linked in a systematic and productive way with the research methodologies currently in use." - Rom Harré, from the Preface. "By providing examples of the experience of counsellors in pursuing research projects that have meaning and value for their clients and themselves, the contributors to the book are able to show that research can indeed represent a significant means of extending and deepening insight and understanding in ways that are relevant to understanding the purpose and process of therapy, and which enhance rather than undermine the therapeutic relationship." - John McLeod, from the Foreword. Table of ContentsHarré, Preface. Gardner, Introduction. Gardner, Coombs, Learning and Researching as an Adult Professional. Gardner, Coombs, Ethical Dilemmas in Training and in Research. Gardner, Coombs, Using the Case Study Approach for Training and Research. Gardner, Coombs, Choosing a Research Paradigm. Whitehead, Research Using Focus Groups in an Organisational Setting. Barnet, Research in the Voluntary Sector. Larcombe, Research in the Public Sector. Cole, Research in the Community with a Feminist Approach. Larcombe, Gardner, Coombs, Going Public – Getting Your Work Out to a Wider Audience. Coombs, The Way Forward.

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Book SynopsisClinical Diabetes Research: Methods and Techniques summarizes established state-of-the art-techniques and describes the new technologies and their role in clinical diabetes research.Trade Review"This is a sorely-needed reference not comparable to anything else currently available." (Doody's, February 2008)Table of Contents1 Basics of Clinical Metabolic Research. 2 Methods for the Assessment of b-Cell Function In Vivo. 3 Assessment of Insulin Sensitivity from Steady-State and Dynamic Tests. 4 Glucose Clamp Techniques. 5 Methods of Assessment of Counterregulation to Hypoglycaemia. 6 Glucose Kinetics: Measurement of Flux Rates. 7 Xenobiotics as Probes of Carbohydrate Metabolism. 8 Tracing Hepatic Glucose and Glycogen Fluxes with 2H2O. 9 Lipid Kinetics. 10 Protein and Amino Acid Kinetics. 11 Assessment of Metabolic Fluxes by In Vivo MR Spectroscopy. 12 Positron Emission Tomography in Metabolic Research. 13 Assessment of Body Fat Content and Distribution. 14 Tissue Biopsies in Diabetes Research. 15 Assessment of Vascular Function. 16 Cardiovascular Autonomic Function Testing. 17 Nerve Function Testing. 18 Kidney Function. 19 Techniques for the Investigation of the Eye in Diabetes. 20 Basics of Molecular Genetics: Lessons from Type 2 Diabetes. 21 Good Clinical Practice: Friend or Foe? 22 Statistical Considerations in Diabetes Trials. Index.

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Book SynopsisEstablishes the criteria required to assess benefit-risk in general and reviews the current practice of benefit-risk assessment by drug regulatory authorities and the pharmaceutical industry. Outlines how the new MCDA model was developed and evaluated, and discusses the implications of its implementation into the practice of drug evaluation.Table of ContentsForeword. Preface. 1 Concept and Scope of Benefit–Risk Evaluation of Medicines. 1.1 Historical backgroun. 1.2 The regulatory systems for assessing medicines. 1.3 Benefit–risk assessment: definitions. 1.4 Views and perceptions of benefits and risks of medicines. 1.5 Stages and concepts in benefit–risk assessment. 1.6 Benefit–risk assessment: the current regulatory environment. 1.7 Benefit–risk assessment in other disciplines. 1.8 Specific methods and models for benefit–risk assessment. 1.9 Discussions with stakeholders on the concepts and models for benefit–risk evaluation. 2 Criteria for a Benefit–Risk Model: a Conceptual Framework. 2.1 Introduction. 2.2 Regulatory guidelines on benefit and risk criteria. 2.3 Identification, definition and rationale of relevant benefit and risk criteria. 2.4 Verification of the list of benefit and risk criteria by means of a survey. 3 Review of the Current Benefit–Risk Assessment Models. 3.1 Background. 3.2 Evaluation of the existing benefit–risk assessment models. 3.3 Review of models in single clinical trials and for specific medicines. 3.4 Conclusion. 3.5 Newer models. 4 Defining a Systematic Approach to Decision Making. 4.1 Introduction. 4.2 Objectives and features of the ideal model for benefit–risk assessment. 4.3 The use of decision-analysis techniques for the development of the new model. 5 Development and Application of a Benefit–Risk Assessment Model Based on Multi-Criteria Decision Analysis. 5.1 Introduction. 5.2 Conceptualization of the new model. 5.3 Reasons for using decision analysis techniques in the new model. 5.4 The use of MCDA in the new model. 5.5 Development of the new model. 5.6 Applicability of the new model. 5.7 Summary. 5.8 Review of the MCDA model. 6 A Future Framework for Benefit–Risk Appraisal of Medicines. 6.1 Background. 6.2 Development of a benefit–risk framework for regulatory review of new medicines. 6.3 Prerequisites of a benefit–risk framework for the registration of a new medicine. 6.4 Current status of benefit–risk assessment among companies and agencies. 6.5 Constructing a benefit–risk framework. 6.6 Conclusion. Appendices. Appendix 1 Summary Reports of the CMR International Institute for Regulatory Science March 2004 and June 2005 Workshops on Benefit–Risk. Appendix 2 Office of Health Economics Briefing: Challenges and Opportunities for Improving Benefit–risk Assessment of Pharmaceuticals from an Economic Perspective – James Cross and Louis Garrison (August 2008). Appendix 3 Reflection Paper on Benefit–risk Assessment Methods in the Context of the Evaluation of Marketing Authorisation Applications of Medicinal Products for Human Use – Committee for Medicinal Products for Human Use (March 2008). Appendix 4 Commentaries on ‘A Quantitative Approach to Benefit–risk Assessment of Medicines’ Pharmacoepidemiology and Drug Safety, 2007, 16. Appendix 5 Forum on Benefit: Risk Decision Analysis – Summary of Discussions and Recommendations – MHRA (September 2008). References. Index.

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Book SynopsisBecause the concept and discoveries of cancer stem cells are relatively new, scientists and researchers need an introduction to this dynamic area. Cancer Stem Cells presents a consolidated account of the research done to date and recent progresses in the studies of cancer stem cells. Such a presentation facilitates a better understanding of and draws attention to stem cell and cancer biology - two fields that enhance, move, and evolve into each other continuously. It provides an informative study in designing approaches to apply stem cell principles to cancer biology while offering an overview of the challenges in developing combination stem and cancer biology targets for therapeutics. This book serves as a primer for new researchers in the field of cancer biology.Table of ContentsContributors xi Preface xiii 1 Cancer Stem Cells: Similarities and Variations in the Theme of Normal Stem Cells 1Sharmila Bapat, Anne Collins, Michael Dean, Kenneth Nephew, and Suraiya Rasheed 1.1 Introduction 1 1.2 Stem Cells in the Life of an Organism 2 1.2.1 Stem Cells in Early Development and Fetal Life 3 1.2.2 Stem Cells in the Adult Organism 4 1.3 Cancer Stem Cells 7 1.3.1 Activation of Stem Cells and Cancer 7 1.3.2 Isolation and Identification of Cancer Stem Cells 10 1.3.3 De Novo Generation of a New Organ (Tumor) by Transformed Stem Cells 12 1.4 Self-Renewal and Differentiation in CSCs 13 1.5 CSC Plasticity as Regulated by Intrinsic and Extrinsic Stem Cell Factors 14 1.5.1 Stem Cell Intrinsic Factors: Genetic and Epigenetic Effects 14 1.5.2 Stem Cell Extrinsic Effects: Niche Effects and Microenvironmental Signaling 16 1.6 Conclusions and Future Perspectives 18 References 20 2 Leukemic Stem Cells 27Sharmila Bapat 2.1 Introduction 27 2.2 Dysregulation of Hematopoiesis in Leukemia 28 2.2.1 Normal Hematopoietic Stem Cell Hierarchies 28 2.2.2 Understanding Aberrant Hierarchies in Leukemia 30 2.2.3 Types of Leukemia 31 2.3 Identification and isolation of Cancer-Initiating Cells in Leukemia 35 2.4 Molecular Regulation of Aberrant Hierarchies 36 2.4.1 Signaling Pathways Deregulated in Leukemia 37 2.4.2 Self-Renewal of Normal and Leukemic Stem Cells 39 2.4.3 Epigenetic Effects 40 2.4.4 MicroRNA in Leukemia Development 42 2.5 Conclusions and Future Perspectives 44 References 45 3 Isolation and Characterization of Breast and Brain Cancer Stem Cells 57Meera Saxena and Annapoorni Rangarajan 3.1 Introduction 57 3.2 Breast Cancer Stem Cells 58 3.2.1 Mammary Gland Architecture and Cell Types 58 3.2.2 Breast Cancer 59 3.2.3 Identification of Breast Cancer Stem Cells 59 3.2.4 Putative Breast Cancer Stem Cells that Exhibit the CD44+ CD24-/low Lin- Marker Profile 61 3.2.5 ESA+ Subpopulation of CD24-low Lin- Cells Enriched by Tumorigenicity 61 3.2.6 Tumorigenic Breast Cells Displaying Properties of Stem Cells 61 3.2.7 In Vitro Propagation of Breast Cancer Stem Cells as Mammospheres 62 3.3 Brain Cancer Stem Cells 64 3.3.1 Brain Architecture and Cell Types 64 3.3.2 Brain Cancers 65 3.3.3 Brain Stem Cells 66 3.3.4 Brain Cancer Stem Cells 66 3.3.5 Brain Cancer–Derived Cells that Generate Tumor Spheres 67 3.4 Conclusions and Future Perspectives 69 References 70 4 Cancer Stem Cell Side Populations 73Danuta Balicki and Raymond Beaulieu 4.1 Introduction 73 4.2 Stem Cell Side Populations 75 4.3 Side Populations in Normal Tissue 78 4.4 Side Populations in Tumors 79 4.5 Overcoming Side Population Limitations 80 4.6 Conclusions and Future Perspectives 81 References 82 5 Evidence for Cancer Stem Cells in Retinoblastoma 87Gail M. Seigel 5.1 Introduction 87 5.2 Elusive Origins of Retinoblastoma 87 5.3 Sources of Retinoblastoma Cells for Study 88 5.4 Precedent for Cancer Stem Cells 88 5.5 Side Populations in Retinoblastoma 89 5.6 Immunoreactivity to Stem Cell Markers in Retinoblastoma 89 5.7 Conclusions and Future Perspectives 91 References 92 6 Ovarian Stem Cell Biology and the Emergence of Ovarian Cancer Stem Cells 95Anjali Kusumbe and Sharmila Bapat 6.1 Introduction 95 6.2 Overview of the Human Ovary 95 6.2.1 Histological Landmarks 95 6.2.2 Ovarian Development: The Story Before Birth 96 6.2.3 The Mammalian Oogenesis Dogma 98 6.3 Stem/Progenitor Cells in the Adult Mammalian Ovary 98 6.3.1 Historical Perspective 98 6.3.2 The Oogenesis Dogma Revisited 99 6.4 Is Ovarian Cancer a Stem Cell Disease? 104 6.4.1 Putative Role of Stem/Progenitor Cells in Ovarian Cancer 104 6.4.2 Tumor as an Aberrant Organ Initiated by Cancer Stem Cells 105 6.4.3 Ovarian Cancer Stem Cells Isolated as a Side Population 106 6.4.4 New Challenge: Targeting Ovarian Cancer Stem Cells 106 References 107 7 Prostate Cancer Stem Cells 111Stefanie Hager, Norman J. Maitland, and Anne Collins 7.1 Introduction 111 7.2 Human Prostate Biology Gland Architecture, and Pathological Alterations 111 7.3 Prostate Epithelial Stem Cells 113 7.3.1 Evidence for Prostate Epithelial Stem Cells 113 7.3.2 Isolation of Human Prostate Epithelial Stem Cells and Demonstration of Their Stem Cell Character 116 7.3.3 Epithelial Stem Cells in the Murine Prostate 118 7.3.4 Other Markers of Prostate Epithelial Stem Cells 119 7.4 Prostate Cancer Stem Cells 120 7.4.1 Role of Stem Cells in Prostate Cancer 120 7.4.2 Prospective Isolation of Prostate Cancer Stem Cells from Human Tissue Samples 122 7.4.3 Role of the Stem Cell Niche in Prostate Cancer 124 7.4.4 Putative Markers of Prostate Cancer Stem Cells 124 7.5 Stem Cell Tracking in the Prostate 125 7.6 Conclusions and Future Perspectives 127 References 127 8 Molecular Signatures of Highly Malignant Melanoma Stem Cells 135Suraiya Rasheed 8.1 General Properties of Human Melanomas 135 8.2 Characteristics of Stem Cell–Derived Melanomas 136 8.3 The Cat Model System for Stem Cell Melanomas 137 8.3.1 Biological Characteristics of Highly Malignant Stem Cell Melanomas 138 8.3.2 Trans-differentiation of the Malignant Cat Melanoma into Neuronal Cells 139 8.3.3 Proteins Associated with Neuronal Cell Differentiation 140 8.3.4 Cell Cycle Dysregulation and Antitumorigenic Effects During Cell Differentiation 144 8.3.5 Molecular Signatures of Self Renewal and Long-Term Proliferation of Tumor Cells 145 8.3.6 Proteins Involved in Tumorigenesis and Metastasis 147 8.3.7 Expression of Germline and Embryonic Proteins in Cat Melanomas 149 8.3.8 Naturally Occurring Protein–Protein Interaction Complexes in Melanomas 149 8.3.9 Networks of Protein Interaction Pathways 152 8.4 Challenges of Research in Cancer Stem Cellsand Therapeutics 152 8.5 Conclusions and Future Perspectives 154 References 156 9 Invasion Program of Normal and Cancer Stem Cells 167David Olmeda, Gema Moreno-Bueno, David Sarrió, José Palacios, and Amparo Cano 9.1 Introduction 167 9.2 Basics of Tumor Progression: Invasion and Metastasis 168 9.3 Epithelial-to-Mesenchymal Transition in Development and Its Relation to The Invasive Process 169 9.4 Regulation of EMT: From Signals to Molecular Pathways 172 9.5 EMT and Cancer Stem Cells 176 9.6 Can Stem Cell Properties Be Extensive to Invasive Tumor Cells? 177 9.7 Is There a Unique EMT Program Linked to Invasion? 178 9.8 Evidence of EMT in Human Clinical Tumors 180 9.9 Expression of Mesenchymal Markers and Cadherin Switching in Carcinomas 181 9.10 Expression of EMT Inducers in Human Tumors 183 9.11 Occurrence of EMT in a Specific Subset of Breast Carcinomas 185 9.12 Conclusions and Future Perspectives 186 References 187 10 Epigenetics in Cancer Stem Cell Development 197Kenneth Nephew, Curt Balch, Tim H.-M. Huang, Zhang Shu, Michael Chan, and Pearlly Yan 10.1 Introduction 197 10.2 Characterization of Candidate Cancer Stem Cells 198 10.3 Possible Origins of Cancer Stem Cells 198 10.4 Epigenetics in Normal Development 199 10.5 Epigenetic Regulation of the Cancer Stem Cell Phenotype 200 10.6 Contributions of Epigenetics to Drug Resistance in Cancer Stem Cells 204 10.7 Genome-Wide Interrogation of Epigenetic Modifications in Cancer Stem Cells 206 10.8 Epigenetic Therapies Against Poorly Differentiated Cancer Cells 207 10.9 Conclusions and Future Perspectives 208 References 209 11 Cancer Stem Cells and New Therapeutic Approaches 217Michael Dean 11.1 Cancer Stem Cells 217 11.2 Activation of Stem Cells and Cancer 218 11.2.1 Initiation and Promotion Revised 219 11.2.2 Stem Cell Activation and Specific Cancers 221 11.3 Major Cancers and Risk Factors 223 11.3.1 Liver Cancer 223 11.3.2 Lung Cancer 224 11.3.3 Gastric Cancer 224 11.3.4 Pancreatic Cancer 224 11.3.5 Cervical Cancer 225 11.4 Treatment Implications 225 11.5 Future Perspectives 227 11.6 Conclusions 228 References 243 12 Immunobiology of Cancer Stem Cells 233Shubhada V. Chiplunkar 12.1 Cancer Stem Cells 233 12.2 Cancer Stem Cells and Lymphocytes 234 12.3 Trafficking of Normal Stem Cells and Metastasis of Cancer Stem Cells 236 References 238 Index 243

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Book SynopsisHealth education is a popular and growing undergraduate major and an occupational field that is on the rise. This easy-to-read, user-friendly book provides the information and skills needed for effective production and consumption of research.Table of ContentsTables and Figures xi Preface xiii Acknowledgments xv The Authors xvii Part 1 Understanding Important Research Concepts 1 Introduction to Research in Health and Human Performance 3 What You’ll Learn 3 Defining the Research Process 4 Research Continuum: Applied and Basic Research 10 Summary 14 Review Questions 15 Key Terms 15 2 Concepts in Research Designs 17 What You’ll Learn 17 Overview of Research Designs 18 Understanding Research Variables 20 Measuring Research Variables 24 Interpreting Research Designs 26 Summary 29 Review Questions 30 Key Terms 31 Part 2 Reviewing the Literature 3 Developing Your Research Topic and Interpreting Research Reports 35 What You’ll Learn 35 Identifying the Problem 35 Accessing Sources 44 Reading and Interpreting Research Reports 51 Summary 56 Review Questions 57 Key Terms 57 4 Writing the Review of Literature 59 What You’ll Learn 59 Developing an Outline 60 Writing Scientifically 69 Summary 79 Review Questions 80 Key Terms 80 Part 3 Understanding and Developing Research Designs 5 Quantitative Research Designs 83 What You’ll Learn 83 Descriptive Research Designs 84 Experimental Research Designs 96 Correlation Research Designs 102 Summary 104 Review Questions 105 Key Terms 105 6 Qualitative Research Designs 107 What You’ll Learn 107 Characteristics of Qualitative Research 107 Procedures in Qualitative Research 113 Types of Qualitative Research Designs 120 Summary 126 Review Questions 128 Key Terms 128 7 Mixed-Methods and Action Research Designs 129 What You’ll Learn 129 Overview of Mixed-Methods Research Designs 129 Framework for Mixed-Methods Research Designs 132 Action Research 138 Summary 142 Review Questions 144 Key Terms 144 8 Ethics in Research 145 What You’ll Learn 145 Ethics Within Research 146 Summary 159 Review Questions 160 Key Terms 160 9 Developing Your Research Proposal 161 What You’ll Learn 161 Sampling 162 Writing Your Introduction 168 Developing Your Methods 174 Summary 179 Review Questions 179 Key Terms 180 Part 4 Exploring Measurement and Analysis 10 Validity, Reliability, Objectivity 183 What You’ll Learn 183 Validity Concepts 184 Reliability Concepts 195 Objectivity Concepts 200 Summary 201 Review Questions 202 Key Terms 203 11 Introduction to Statistics and Hypothesis Testing 205 What You’ll Learn 205 Introduction to Statistics 206 Descriptive Statistics 215 Hypothesis Testing 219 Summary 224 Review Questions 225 Key Terms 225 12 Quantitative Data Analysis 227 What You’ll Learn 227 Inferential Statistics 227 Examining Relationships 230 Examining Differences 236 Examining Type I and Type II Errors 247 Summary 248 Review Questions 249 Key Terms 249 13 Qualitative Analysis: Interpreting the Data 251 What You’ll Learn 251 Recording Your Data 251 Managing Your Data 253 Writing the Report 258 Trustworthiness of the Data 265 Summary 267 Review Questions 268 Key Terms 269 14 Results and Discussion: Writing What You Found 271 What You’ll Learn 271 Results Section 272 Discussion Section 275 Writing Your Abstract 279 Summary 280 Review Questions 281 Part 5 Putting It All Together 15 Presenting Your Research 285 What You’ll Learn 285 Poster Presentations 286 Oral Presentation 295 Summary 301 Review Questions 301 Glossary 303 References 311 Index 319

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Book SynopsisProviding a broad overview of the microbial pathogens associated with hospital-acquired human illness, Techniques for the Study of Hospital Acquired Infection examines the cost-effective use of laboratory techniques in nosocomial infectious disease epidemiology and control.Table of ContentsContributors. Forword. Preface. Dedication. I. Introduction to Healthcare Associated Infections and Their Control. 1. The Hospital and Ambulatory Care Environment (Anne Y. Chen and Hiren Pokharma). 2. Pathogen Transmission in the Healthcare Setting (Sonja Hansen and Ralf-Peter Vonberg). 3. Infection Control Basics (Louise-Marie Dembry and Carlos Torres-Viera). 4. Cost-Effectiveness of IC Program (Marc-Oliver Wright and Eli N. Perencevich). 5. Outbreak Investigations (Importance of the Healthcare Epidemiologist) (Marcus J. Zervos). 6. Pathogen Elimination: Antibiotic and Disinfectant Use and the Development of Resistance (Steven L. Foley, Beilei Ge, Carl M. Schroeder, and Arron M. Lynne). II. Techniques to Characterize Nosocomial Pathogens. 7. Rapid PCR Screening Methods (Ngolela Esther Babady, Frankling Cockerill and Robin Patel). 8. Restriction Analysis Techniques (Richard V. Goering, Mary Stemper, SanjayShukla and Steven Foley). 9. Pulsed-field Gel Electrophoresis (Mary Stemper, Steven Foley Richard V. Goering, and Sanjay Shukla). III. Application of Techniques to Characterize Predominant Nosocomial Pathogens. 10. Staphylococcus aureus (Vanthida Huang). 11. Escherichia coli (Johann D. D. Pitout). 12. Fungal Infections (Jose A. Vazquez). Index.

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Book SynopsisPraise for the First Edition . . . an excellent textbook . . . an indispensable reference for biostatisticians and epidemiologists. International Statistical Institute A new edition of the definitive guide to classical and modern methods of biostatistics Biostatistics consists of various quantitative techniques that are essential to the description and evaluation of relationships among biologic and medical phenomena. Biostatistical Methods: The Assessment of Relative Risks, Second Edition develops basic concepts and derives an expanded array of biostatistical methods through the application of both classical statistical tools and more modern likelihood-based theories. With its fluid and balanced presentation, the book guides readers through the important statistical methods for the assessment of absolute and relative risks in epidemiologic studies and clinical trials with categorical, count, and event-time data. Presenting a brTrade Review"Biostatistical methods, second edition is an excellent book for biostatistics courses at the graduate level. It is also an invaluable reference for biostatisticians, applied statisticians, and epidemiologists." (Mathematical Reviews, 2011) "The author of this book has made a tremendous effort in covering a gamut of tests, methods, and ideas for biostatistical problem solving . . . In conclusion, the book is recommended to all in biostatistics as a technical reference." (Journal of Biopharmaceutical Statistics, 1 September 2012) "...Biostatistics is set apart from other statistics specialties by its focus on the assessment of risks and relative risks through clinical research," states Lachin (George Washington U.) in the preface to the first edition (2001). He developed this graduate text to support a course he launched as a joint initiative of the university's department of statistics, its Biostatistics Center, and the School of Public Health and Health Services. Coverage includes discussion of biostatistics and biomedical science, relative risk estimates and tests for independent groups, sample size, stratified adjusted analysis, case-control and matched studies, applications of maximum likelihood and efficient scores, among other topics." (Book News Inc., February 2011) Table of ContentsPreface. Preface to First Edition. 1 Biostatistics and Biomedical Science. 1.1 Statistics and the Scientific Method. 1.2 Biostatistics. 1.3 Natural History of Disease Progression. 1.4 Types of Biomedical Studies. 1.5 Studies of Diabetic Nephropathy. 2 Relative Risk Estimates and Tests for Independent Groups. 2.1 Probability As a Measure of Risk. 2.2 Measures of Relative Risk. 2.3 Large Sample Distribution. 2.4 Sampling Models Likelihoods. 2.5 Exact Inference. 2.6 Large Sample Inferences. 2.7 SAS PROC FREQ. 2.8 Other Measures of Differential Risk. 2.9 Polychotomous and Ordinal Data. 2.10 Two Independent Groups With Polychotomous Response. 2.11 Multiple Independent Groups. 2.12 Problems. 3 Sample Size, Power, and Efficiency. 3.1 Estimation Precision. 3.2 Power of Z-Tests. 3.3 Test for Two Proportions. 3.4 Power of Chi-Square Tests. 3.5 SAS PROC POWER. 3.6 Efficiency. 3.7 Problems. 4 Stratified-Adjusted Analysis for Independent Groups. 4.1 Introduction. 4.2 Mantel-Haenszel Test and Cochran’s Test. 4.3 Stratified-Adjusted Estimators. 4.4 Nature of Covariate Adjustment. 4.5 Multivariate Tests of Hypotheses. 4.6 Tests of Homogeneity. 4.7 Efficient Tests of No Partial Association. 4.8 Asymptotic Relative Efficiency of Competing Tests. 4.9 Maximin-Efficient Robust Tests. 4.10 Random Effects Model. 4.11 Power and Sample Size for Tests of Association. 4.12 Polychotomous and Ordinal Data. 4.13 Problems. 5 Case-Control and Matched Studies. 5.1 Unmatched Case-Control (Retrospective) Sampling. 5.2 Matching. 5.3 Tests of Association for Matched Pairs. 5.4 Measures of Association for Matched Pairs. 5.5 Pair-Matched Retrospective Study. 5.6 Power Function of McNemar’s Test. 5.7 Stratified Analysis of Pair-Matched Tables. 5.8 Multiple Matching-Mantel-Haenszel Analysis. 5.9 Matched Polychotomous Data. 5.10 Kappa Index of Agreement. 5.11 Problems. 6 Applications of Maximum Likelihood and Efficient Scores. 6.1 Binomial. 6.2 2x2 Table: Product Binomial (Unconditionally). 6.3 2x2 Table, Conditionally. 6.4 Score-Based Estimate. 6.5 Stratified Score Analysis of Independent 2x2 Tables. 6.6 Matched Pairs. 6.7 Iterative Maximum Likelihood. 6.8 Problems. 7 Logistic Regression Models. 7.1 Unconditional Logistic Regression Model. 7.2 Interpretation of the Logistic Regression Model. 7.3 Tests of Significance. 7.4 Interactions. 7.5 Measures of the Strength of Association. 7.6 Conditional Logistic Regression Model for Matched Sets. 7.7 Models for Polychotomous or Ordinal Data. 7.8 Random Effects and Mixed Models. 7.9 Models for Multivariate or Repeated Measures. 7.10 Problems. 8 Analysis of Count Data. 8.1 Event Rates and the Homogeneous Poisson Model. 8.2 Over Dispersed Poisson Model. 8.3 Poisson Regression Model. 8.4 Over Dispersed and Robust Poisson Regression. 8.5 Conditional Poisson Regression for Matched Sets. 8.6 Negative Binomial Models. 8.7 Power and Sample Size. 8.8 Multiple Outcomes. 8.9 Problems. 9 Analysis of Event-Time Data. 9.1 Introduction to Survival Analysis. 9.2 Lifetable Construction. 9.3 Family of Weighted Mantel-Haenszel Tests. 9.4 Proportional Hazards Models. 9.5 Evaluation of Sample Size and Power. 9.6 Additional Models. 9.7 Analysis of Recurrent Events. 9.8 Problems. Appendix Statistical Theory. A.1 Introduction. A.2 Central Limit Theorem and the Law of Large Numbers. A.3 Delta Method. A.4 Slutsky’s Convergence Theorem. A.5 Least Squares Estimation. A.6 Maximum Likelihood Estimation and Efficient Scores. A.7 Tests of Significance. A.8 Explained Variation. A.9 Robust Inference. A.10 Generalized Linear Models and Quasi-Likelihood. A.11 Generalized Estimating Equations (GEE). References. Author Index. Subject Index.

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Book SynopsisThis book addresses the statistical, practical, and ethical issues arising from allocating groups of individuals, or clusters, to different interventions.Trade Review“There are several unique strengths to this book. In particular the authors are very experienced statisticians having worked for many years in the design and analysis of cluster randomized trials and have written excellent methodological articles many of which are cited in their book.” (Journal of Biopharmaceutical Statistics, 2012) Table of ContentsPreface xiii Notation xv Table of cases: Trials used as examples in more than one chapter in the book xviii 1 Introduction 1 1.1 Introduction to randomised trials 2 1.2 Explanatory or pragmatic trials 2 1.3 How does a cluster randomised trial differ from other trials? 3 1.4 Between-cluster variability 9 1.5 Why carry out cluster randomised trials? 10 1.6 Quality of evidence from cluster randomised trials 13 1.7 Historical perspectives 16 1.8 Summary 18 References 19 2 Recruitment and ethics 22 2.1 Selecting clusters and participants to enhance external validity 22 2.2 Ethics of cluster randomised trials 24 2.3 Selection and recruitment of participants to enhance internal validity 35 2.4 Retention of participants in the trial 41 2.5 Summary 41 References 41 3 Designing interventions 44 3.1 Lack of effectiveness of interventions evaluated in cluster randomised trials 45 3.2 What is a complex intervention? 46 3.3 Phases in the development of a complex intervention 50 3.4 Identifying evidence for potential intervention effect (pre-clinical phase) 50 3.5 Understanding more about intervention components (modelling phase) 53 3.6 Developing the optimum intervention and study design (exploratory trial phase) 55 3.7 What is the intervention? 57 3.8 Summary 58 References 58 4 Pilot and feasibility studies 60 4.1 What is a pilot study? 60 4.2 Reasons for conducting pilot and feasibility studies 63 4.3 Designing a pilot or feasibility study 69 4.4 Reporting and interpreting pilot studies 71 4.5 Summary 72 References 73 5 Design 74 5.1 Parallel designs with only two arms 75 5.2 Cohort versus cross-sectional designs 85 5.3 Parallel designs with more than two arms 88 5.4 Crossover designs 92 5.5 Further design considerations 95 5.6 Summary 96 References 96 6 Analysis 99 6.1 Data collection and management 99 6.2 Analysis – an introduction 101 6.3 Analyses for two-arm, completely randomised, stratified or minimised designs 104 6.4 Analyses for other designs 124 6.5 Intention to treat and missing values 129 6.6 Analysis planning 131 6.7 Summary 132 References 133 7 Sample size calculations 137 7.1 Factors affecting sample size for cluster randomised designs 138 7.2 Calculating sample size using the intra-cluster correlation coeffi cient 142 7.3 Sample size calculations for rates 145 7.4 Restricted number of clusters 146 7.5 Trials with a small number of clusters 149 7.6 Variability in cluster size 150 7.7 Comparison of different measures of between-cluster variability 154 7.8 Matched and stratifi ed designs 160 7.9 Sample size for other designs 166 7.10 Summary 169 References 169 8 The intra-cluster correlation coeffi cient 172 8.1 What is the ICC? 173 8.2 Sources of ICC estimates 175 8.3 Choosing the ICC for use in sample size calculations 179 8.4 Calculating ICC values 185 8.5 Uncertainty in ICCs 192 8.6 Summary 193 References 193 9 Other topics 196 Richard Grieve 9.1 Systematic reviews 197 9.2 Cost effectiveness analyses 207 9.3 Process evaluation 212 9.4 Monitoring 213 9.5 Summary 215 References 215 10 Trial reporting 218 10.1 Trial quality and reporting quality 218 10.2 Steps to improve trial reporting in the early stages of the trial 227 10.3 Reporting randomised trials in journal and conference abstracts 230 10.4 Application of CONSORT statement to cluster randomised trials 232 10.5 Summary 262 References 263 Index 267

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