Do placebos work? For many conditions, you bet they do! Maybe in some people most of the time; maybe even in all people some of the time. Those are among the conclusions that experts drew from a comprehensive review of placebo effects that took place at the National Institutes of Health. The meeting, designed to bring basic biomedical and behavioral scientists together with clinicians and clinical trial experts, developed an expanded concept of the placebo, explored a variety of explanatory mechanisms of why placebos work when they work, and discussed the pros and cons of using placebos in clinical trials. The experts went on to develop a research agenda to further progress in the field.

The result is a new look at placebos, one that calls for careful consideration of the complex ethical issues involved in exploiting placebo effects, but sees their potential as therapeutic allies in clinical practice.

The chapters serve as an essential practical and theoretical guide to practitioners, researchers, bioethicists, patients, and students who want a comprehensive review of the state of placebo science and placebo-controlled clinical trials. They include:
The historical context and ethical perspectives
Explanatory psychosocial and physiological mechanisms (for example, social and cultural meanings, classic conditioning, social learning, intervening psychophysiology)
The need to distinguish placebo effects from biological and statistical artifacts
Issues concerning the use of placebo groups in clinical trials: ethics, methodological issues, pros, cons, and alternatives
Priorities for future research

The publication of this book has importantimplications for clinical medicine, making it essential reading for clinical researchers, basic scientists and health care practitioners.

Integrated Drug Discovery Technologies provides a global overview of emerging drug development technologies by presenting and integrating new techniques from the disciplines of chemistry, biology, and computational sciences. It combines integration of contemporary mechanization with strategies in drug delivery. Topics include: functional genomics, microfabrication techniqes, integrated proteomics technologies, high throughput screening, and fluorescence correlation spectroscopy methods.

Originally published in 1997 Evolutionary Change addresses the somatic mechanism of change. Although astounding advances in molecular biology have opened up new engineering possibilities to shape our future in terms of "improving" the human species as well as eradicating all kinds of pathological characteristics of biological development, these possibilities pose potentially serious dangers. They arise primarily from the local nature of changes that are introduced and the impact of the environment on the overall development of the biological system. The book explores the biological mechanisms of change in their entirety - as they fit into the general dynamics of biological systems - and demonstrates the pitfalls of tackling change from a narrow perspective, using cancer as an example of certain pathological manifestations of these mechanisms of change.

First published in 1998, this volume examines a major function of research which is to strengthen the knowledge base of health professions and so enhance patient care. The rapid growth has unfortunately led to it being seen by many as an elitist activity full of jargon, carried out by academics. This to some degree has led to a theory practice gap with some professionals not recognising their important role within the research process. It is important to dispel the myth that all practitioner should carry out research, though they should use elements of the research process to develop a questioning and evaluative approach to care. This book will enable reader to demystify and enhance their understanding of terminology used in research and contains almost 300 terms. It offers readers a unique approach to explanations for each term by offering its Everyday use; its Research use; an Example and Related terms.

The discovery of ER by Dr. Elwood Jensen exactly 60 years ago has not only led to the birth of a whole new vital nuclear receptor research field but also made a rapid, direct and lasting impact on the treatment and prevention of breast cancer. Since that landmark discovery, tremendous progress has been made in our understanding of the molecular functions of ER and development of targeted therapies against ER pathways for breast cancer treatment. However, there is currently no book available addressing these discoveries and recent advancement in a historical and systematic fashion. This book is intended to provide comprehensive, most up-to-date information on the history and recent advancement of ER and breast cancer by world renowned leaders in the field. These chapters include the history of the discovery of ER; physiological and pathological roles of ER; recent discovery of ER cistrome, transcriptome and its regulation of noncoding RNAs such as microRNAs and enhancer RNAs in breast cancer; development and clinical practices of the first targeted therapy Tamoxifen and other antiestrogens for breast cancer treatment; structural basis of ER and antiestrogen actions; molecular insights into endocrine resistance; the role of ER mutants, ER-beta and environmental estrogens in breast cancer; and emerging state-of-the-art therapeutic approaches currently in development to overcome treatment resistance and future perspectives. The book will provide undergraduate and graduate students, basic scientists and clinical cancer researchers, residents, fellows, as well as clinicians, oncology educators and the general public a thorough and authoritative review of these exciting topics.

This book provides deep insight into the significance of various forensic techniques underlying the methodical approaches in criminal investigations. The book comprises numerous case studies, examples, and reference materials. It emphasizes on the better practices for criminal investigations including contemporary examinations. The book also describes various methods for investigation of crime scene and evidence collection including biological evidences to the resources of law enforcement agencies. This book encompasses the procedure for crime scene-documentation through photography, video, and diagrams and highlights the best practices of packaging the biological evidences at a crime scene. Further, it summarizes the role of forensic autopsy to the criminal investigation system. As such, the book is helpful for forensic scientists, medical practitioners, educators and law enforcement personnel.

Mathematical and Statistical Skills in the Biopharmaceutical Industry: A Pragmatic Approach describes a philosophy of efficient problem solving showcased using examples pertinent to the biostatistics function in clinical drug development. It was written to share a quintessence of the authors' experiences acquired during many years of relevant work in the biopharmaceutical industry. The book will be useful will be useful for biopharmaceutical industry statisticians at different seniority levels and for graduate students who consider a biostatistics-related career in this industry. Features: Describes a system of principles for pragmatic problem solving in clinical drug development. Discusses differences in the work of a biostatistician in small pharma and big pharma. Explains the importance/relevance of statistical programming and data management for biostatistics and necessity for integration on various levels. Describes some useful statistical background that can be capitalized upon in the drug development enterprise. Explains some hot topics and current trends in biostatistics in simple, non-technical terms. Discusses incompleteness of any system of standard operating procedures, rules and regulations. Provides a classification of scoring systems and proposes a novel approach for evaluation of the safety outcome for a completed randomized clinical trial. Presents applications of the problem solving philosophy in a highly problematic transfusion field where many investigational compounds have failed. Discusses realistic planning of open-ended projects.

This book provides readers with an integrative overview of the latest research and developments in the broad field of biomedical engineering. Each of the chapters offers a timely review written by leading biomedical engineers and aims at showing how the convergence of scientific and engineering fields with medicine has created a new basis for practically solving problems concerning human health, wellbeing and disease. While some of the latest frontiers of biomedicine, such as neuroscience and regenerative medicine, are becoming increasingly dependent on new ideas and tools from other disciplines, the paradigm shift caused by technological innovations in the fields of information science, nanotechnology, and robotics is opening new opportunities in healthcare, besides dramatically changing the ways we actually practice science. At the same time, a new generation of engineers, fluent in many different scientific "languages," is creating entirely new fields of research that approach the "old" questions from a new and holistic angle. The book reports on the scientific revolutions in the field of biomedicine by describing the latest technologies and findings developed at the interface between science and engineering. It addresses students, fellows, and faculty and industry investigators searching for new challenges in the broad biomedical engineering fields.

Study the latest research findings by international experts This comprehensive volume presents state-of-the-art scientific research on the therapeutic uses of cannabis and its derivatives. All too often, discussions of the potential medical uses of this substance are distorted by political considerations that have no place in a medical debate. Cannabis and Cannabinoids: Pharmacology, Toxicology, and Therapeutic Potential features fair, equitable discussion of this emerging and controversial medical topic by the world's foremost researchers. Cannabis and Cannabinoids examines the benefits, drawbacks, and side effects of medical marijuana as a treatment for various conditions and diseases. This book discusses the scientific basis for marijuana's use in cases of pain, nausea, anorexia, and cachexia. It also explores its possible benefits in glaucoma, ischemia, spastic disorders, and migraine. Cannabis and Cannabinoids examines all facets of the medical use of marijuana, including: botany history biochemistry pharmacology clinical use toxicology side effects Cannabis and Cannabinoids is a reference work that will become indispensable to physicians, psychologists, researchers, biochemists, graduate students, and interested members of the public. No other book available offers this comprehensive, even-handed look at a deeply divisive subject.

Aimed at those already involved in drug development or those considering entering the field, Clinical Drug Trials and Tribulations, Second Edition comprehensibly addresses the new, day-to-day challenges of drug development with valuable assessments of the areas affecting the conduction of nonclinical and clinical studies. Addressing which decisions should be made during drug development, this updated and expanded text/reference carefully guides readers through the various trials and tribulations that emerge phase-by-phase and are pertinent to all levels of pharmaceutical or clinical drug management. Bringing together the latest information on drug development, the Second Edition contains: new material on... -international regulation and deregulation -venture capitalist investment -the IND process -informed consent -changes in manufacturing and updated and extended coverage of... -pediatric drug trial design -the advantages and disadvantages of orphan drug designations -the maximization of package inserts for marketing -post approval safety surveillance -withdrawals from the drug market Clinical Drug Trials and Tribulations, Second Edition will prove an invaluable reference for pharmacologists, pharmacists, clinical chemists, clinical coordinators, clinical monitors, government drug regulatory personnel, and bioethicists as well as a useful text for medical or pharmacy school courses on pharmaceutical development and research.

From 1932 to 1972, the United States Public Health Service conducted a non-therapeutic experiment involving over 400 black male sharecroppers infected with syphilis. The Tuskegee Study had nothing to do with treatment. It purpose was to trace the spontaneous evolution of the disease in order to learn how syphilis affected black subjects. The men were not told they had syphilis; they were not warned about what the disease might do to them; and, with the exception of a smattering of medication during the first few months, they were not given health care. Instead of the powerful drugs they required, they were given aspirin for their aches and pains. Health officials systematically deceived the men into believing they were patients in a government study of "bad blood", a catch-all phrase black sharecroppers used to describe a host of illnesses. At the end of this 40 year deathwatch, more than 100 men had died from syphilis or related complications. "Bad Blood" provides compelling answers to the question of how such a tragedy could have been allowed to occur. Tracing the evolution of medical ethics and the nature of decision making in bureaucracies, Jones attempted to show that the Tuskegee Study was not, in fact, an aberration, but a logical outgrowth of race relations and medical practice in the United States. Now, in this revised edition of "Bad Blood", Jones traces the tragic consequences of the Tuskegee Study over the last decade. A new introduction explains why the Tuskegee Study has become a symbol of black oppression and a metaphor for medical neglect, inspiring a prize-winning play, a Nova special, and a motion picture. A new concluding chapter shows how the black community's wide-spread anger and distrust caused by the Tuskegee Study has hampered efforts by health officials to combat AIDS in the black community. "Bad Blood" was nominated for the Pulitzer Prize and was one of the "N.Y. Times" 12 best books of the year.

This introductory text to evidence-based practice provides nurses and other health professionals with a clear idea of why they should use research information as a basis for high-quality patient care and how they should use that information in the clinical setting. In a logical progression which helps the student build knowledge systematically Evidenced-Informed Nursing looks at:
*the rationale for evidence-based care
*what research is and approaches to it
*the benefits of research to clinical practice
*critical appraisal skills
*reflective practice and decision-making
*how to put research into practice
*the importance of research dissemination
A summary of essential points to remember is included at the end of each chapter and the text is firmly grounded in the clinical context. It is suitable for use at all levels of training and practice.

This introductory text to evidence-based practice provides nurses and other health professionals with a clear idea of why they should use research information as a basis for high-quality patient care and how they should use that information in the clinical setting. In a logical progression which helps the student build knowledge systematically Evidenced-Informed Nursing looks at:
*the rationale for evidence-based care
*what research is and approaches to it
*the benefits of research to clinical practice
*critical appraisal skills
*reflective practice and decision-making
*how to put research into practice
*the importance of research dissemination
A summary of essential points to remember is included at the end of each chapter and the text is firmly grounded in the clinical context. It is suitable for use at all levels of training and practice.

This book details several important medicinal plants, their occurrence, plant compounds and their chemical structures, and pharmacological properties against various human diseases. It also gives information on isolation and structural elucidation of phytocompounds, bio-assays, metabolomic studies, and therapeutical applications of plant compounds.

Cell biology is a rapidly advancing subject. Understanding principles of nuclear architecture is a key question. Researchers are starting to develop more strict and rigorous methods of image processing and quantitative analysis to provide an end-to-end process supporting the fundamental biology.

This book has chapters contributed by experts in the field that address the whole endeavour of teasing out the principles of nuclear architecture: ranging from fundamental science, through imaging processing and quantitative analysis, to applications, related to disease. This material is focussed on the latest breakthroughs, and moreover will emphasise a strict and rigorous development of the scientific process. A systems view is stressed where relevant. The objective is not to provide an encyclopaedic compendium of nuclear architecture information, but rather to present state of the art tools in specific contexts, which will readily generalise.

Animal Models in Cancer Drug Discovery brings forward the most cutting-edge developments in tumor model systems for translational cancer research. The reader can find under this one volume virtually all types of existing and emerging tumor models in use by the research community. This book provides a deeper insight on how these newer models could de-risk modern drug discovery. Areas covered include up to date information on latest organoid derived models and newer genetic models. Additionally, the book discusses humanized animal tumor models for cancer immunotherapy and how they leverage personalized therapies. The chapter on larger animal, canine models and their use in and their use in pre-investigational new drug (pre-IND) development makes the volume unique. Unlike before, the incorporation of several simplified protocols, breeding methodologies, handling and assessment procedures to study drug intervention makes this book a must read. Animal Models in Cancer Drug Discovery is a valuable resource for basic and translational cancer researchers, drug discovery researchers, contract research organizations, and knowledge seekers at all levels in the biomedical field.

Open Access Data is emerging as a source for cutting edge scholarship. This concise book provides guidance from generating a research idea to publishing results. Both young researchers and well-established scholars can use this book to upgrade their skills with respect to emerging data sources, analysis, and even post-publishing promotion. At the end of each chapter, a tutorial simulates a real example, allowing readers to apply what they learned about accessing open data, and analyzing this data to reach the results. This book can be of use by established researchers analyzing data, publishing, and actively promoting ongoing and research. Key selling features: Describes the steps, from A-Z, for doing open data research Includes interactive tutorials following each chapter Provides guidelines for readers so that they can use their own accessed open data Reviews recent software and websites promoting and enabling open data research Supplements websites which update recent open data sources

Undue Risk is an unprecedented and chilling history of the use of human subjects in atomic, biological and chemical warfare experiments by the US Government from World War II to the present. Jonathan Moreno, a senior researcher on the President's special commission, goes where few researchers have gone before, exploring secret government documents which reveal a plethora of government experiments.
Now available in paperback, with a new afterword, this exciting read covers recent objections by US military personnel to required anthrax vaccinations and new developments in government policies on experiments involving vulnerable human subjects.

This title was first published in 2003: As new medical technologies and treatments develop with increasing momentum, the legal and ethical implications of research involving human participants are being called into question as never before. Human Experimentation and Research explores the philosophical foundations of research ethics, ongoing regulatory dilemmas, and future challenges raised by the rapid globalisation and corporatisation of the research endeavour. This volume brings together some of the most significant published essays in the field. The editors also provide an informative introduction, summarizing the area and the relevance of the articles chosen.

This extensive book brings together leading melanoma researchers from across the world and highlights many of the cutting-edge protocols and experimental systems currently being used to investigate questions surrounding this disease. The volume opens with sections on 2D and 3D cell culture-based approaches for studying melanoma biology, and continues with collections of chapters examining various approaches for detecting, isolating, and characterizing circulating melanoma cells, circulating tumor DNA, and exosomes, as well as experimental procedures for studying and detecting melanoma metastasis in both pre-clinical and clinical settings, bioinformatics-based approaches, protocols for quantifying and characterizing immune cell infiltrates in both melanoma tumors and tertiary lymphoid structures, and development and evaluation of therapeutic strategies for melanoma treatment. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and comprehensive, Melanoma: Methods and Protocols aims to serve basic research scientists and clinicians who bring questions from the clinic into the lab in order to translate observations in the laboratory into improved patient care for this highly malignant form of cancer. Chapter 14 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.

Uniquely organized to help readers find and select the best frameworks for their needs This resource illuminates the daunting task of understanding and applying philosophies, models, theories, and taxonomies in nursing practice and research at the masters or doctoral level. Distinguished by a unique organizational structure, the text is divided into two broad areas of practice/focus; individuals and families (Part II) and communities, populations, and systems (Part III). The frameworks in each area are organized conceptually into 17 chapters, many of which are interdisciplinary, thus not commonly found in nursing theory texts. This unique organizational structure enables readers to acquire both a broad overview of frameworks useful in nursing practice and research, and to focus on frameworks relevant to specific practice areas and concepts of interest. Frameworks for Advanced Nursing Practice and Research also provides foundational knowledge to enhance the nurse's understanding and appreciation of frameworks used in practice and research (Part 1). Application is woven throughout the text and culminates with chapters devoted to the application of frameworks for nurse educators, clinicians, leaders, and researchers. Learner-focused features of the text include application boxes highlighting published studies that have employed selected frameworks, thereby bringing theoretical content into practice. Each chapter also includes objectives, key terms, and a bulleted summary to enhance the learning experience. Key Features: Describes a broad spectrum of philosophies, models, theories, and taxonomies underpinning graduate-level nursing roles Uniquely organized by conceptual areas, thereby integrating nursing and non-nursing frameworks Facilitates easy comparison of frameworks within each conceptual area Delivers strategies for using theory and discusses integration of theory, research, and practice Includes application boxes highlighting published studies, objectives, key terms, and bulleted chapter summary.

Thiscomprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book:

Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines

Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures

Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers

This book is a useful resource to scientists and researchers in bothindustry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development."

This narrative of a cancer researcher spans a period in which biomedicine research has been so revolutionary. The educational background and socioeconomic circumstances of the author make the story unique, shedding light on many important intellectual achievements. The author also provides an insightful view on how decisions at the upper echelon of scientific institutions affect cancer researchers. The vivid account of scientific discovery and intellectual evolution provides a fine example for the next generation of cancer researchers.

Open Access Data is emerging as a source for cutting edge scholarship. This concise book provides guidance from generating a research idea to publishing results. Both young researchers and well-established scholars can use this book to upgrade their skills with respect to emerging data sources, analysis, and even post-publishing promotion. At the end of each chapter, a tutorial simulates a real example, allowing readers to apply what they learned about accessing open data, and analyzing this data to reach the results. This book can be of use by established researchers analyzing data, publishing, and actively promoting ongoing and research. Key selling features: Describes the steps, from A-Z, for doing open data research Includes interactive tutorials following each chapter Provides guidelines for readers so that they can use their own accessed open data Reviews recent software and websites promoting and enabling open data research Supplements websites which update recent open data sources

Platform trials test multiple therapies in one indication, one therapy for multiple indications, or both. These novel clinical trial designs can dramatically increase the cost-effectiveness of drug development, leading to life-altering medicines for people suffering from serious illnesses, possibly at lower cost. Currently, the cost of drug development is unsustainable. Furthermore, there are particular problems in rare diseases and small biomarker defined subsets in oncology, where the required sample sizes for traditional clinical trial designs may not be feasible. The editors recruited the key innovators in this domain. The 20 articles discuss trial designs from perspectives as diverse as quantum computing, patient's rights to information, and international health. The book begins with an overview of platform trials from multiple perspectives. It then describes impacts of platform trials on the pharmaceutical industry's key stakeholders: patients, regulators, and payers. Next it provides advanced statistical methods that address multiple aspects of platform trials, before concluding with a pharmaceutical executive's perspective on platform trials. Except for the statistical methods section, only a basic qualitative knowledge of clinical trials is needed to appreciate the important concepts and novel ideas presented.