Repeated Measures Design with Generalized Linear Mixed Models for Randomized Controlled Trials is the first book focused on the application of generalized linear mixed models and its related models in the statistical design and analysis of repeated measures from randomized controlled trials. The author introduces a new repeated measures design called S:T design combined with mixed models as a practical and useful framework of parallel group RCT design because of easy handling of missing data and sample size reduction. The book emphasizes practical, rather than theoretical, aspects of statistical analyses and the interpretation of results. It includes chapters in which the author describes some old-fashioned analysis designs that have been in the literature and compares the results with those obtained from the corresponding mixed models. The book will be of interest to biostatisticians, researchers, and graduate students in the medical and health sciences who are involved in clinical trials. Author Website:Data sets and programs used in the book are available at http://www.medstat.jp/downloadrepeatedcrc.html

Topics in Vaccine Adjuvant Research provides a concise, focused review of the immunological basis of adjuvant activity. The first section of the book contains several chapters that discuss key issues in cellular immunology, such as antigen processing and presentation, cytokine regulation of immune responses, and mucosal immunology. The second section consists of brief chapters on the mechanism of action of several adjuvants, including IL-2, nonionic block polymers, and cholera toxin. The major goals of this book are to define what is known about the mechanisms of adjuvant activity, show how research in cellular immunology can be used to help understand adjuvant action, and define possible areas where adjuvants might be useful probes for dissecting basic immunological processes. Immunologists, microbiologists, and infectious disease researchers will find this book an invaluable addition to their reference library.

Lactoferrin is an iron-binding glycoprotein belonging to the transferrin family. It acts as a defense in host animals against microbes and viruses, since it has a broad spectrum of antimicrobial and antiviral activities. Lactoferrin has been shown to regulate the growth and differentiation of many types of cells. The results of recent studies indicate that lactoferrin is a potent regulator of dermal fibroblasts, and promotes cutaneous wound healing. The collagen gel contraction, a model of wound contraction during wound healing process, and migration of human fibroblasts were enhanced by lactoferrin. LRP-1 (LDL Receptor related Protein-1) acts as a signaling receptor for lactoferrin that mediate fibroblast response to lactoferrin by activating ERK/MAPK signaling pathway. In addition, lactoferrin promotes biosynthesis of extracellular matrix (ECM) component such as type-I collagen and hyaluronan. Hyaluronan is a major component of ECM in connective tissue and promotes wound healing. The promoting effect of lactoferrin on hyaluronan production was accompanied by promotion of HAS2 (hyaluronan synthase 2) expression. These observations suggest that lactoferrin promotes the wound healing by providing an ECM that promotes fibroblast migration. Lactoferrin is also known for its anti-inflammatory and immune modulating properties. According to recent in vivo study, lactoferrin promotes wound repair by promoting the early inflammatory phase of wound healing. Based on this, recombinant human lactoferrin was subsequently tested clinically in a Phase II trial in patients with diabetic ulcers and was found to be effective. Lactoferrin should be further evaluated in patients with diabetic and other types of ulcers.

Data Monitoring in Clinical Trial: A Practical Perspective ist die erweiterte 2. Auflage des weit verbreiteten und viel beachteten Fachbuchs, das erstmals im Jahr 2002 erschienen ist. Es bietet einen fundierten und aktuellen UEberblick uber Datenkontrollkomitees, deren Einrichtung, Zweck und Zustandigkeiten. - Enthalt direkt umsetzbare Handreichungen fur alle, die klinische Studien verwalten und durchfuhren, sowie fur Mitglieder von Datenkontrollkomitees. - Liefert Mitgliedern von Behoerden- und Ethikkommissionen Einblicke in die Kontrolle klinischer Daten. - Diskutiert Themen mit Relevanz fur diejenigen, die in den USA und in Europa an klinischen Studien arbeiten. Die praktischen Handlungsansatze in diesem Buch sind fur Experten aus dem akademischen Bereich, bei Regierungsstellen und aus der Industrie, vor allem fur Medizinstatistiker, Kliniker, Koordinatoren von klinischen Studien von Nutzen, ob sie Studien durchfuhren und/oder begleiten. Ebenso relevant ist dieses Praktikerbuch fur Mitarbeiter bei Regulierungsstellen und im Bereich der Bioethik.

Programmed cell death (PCD) plays pivotal roles in tumor progression, cancer therapeutics and resistance of tumor cells to therapy. This book examines the mechanisms involved in mediating and regulating PCD in cancer. It also provides a detailed indication of the utility of PCD in cancer therapy. The book features chapters on the current and future of RNA interference in therapeutics and Pathways involved in Stem Cell Survival and Death.

Healing Plants of Nigeria: Ethnomedicine and Therapeutic Applications offers comprehensive information on the use of herbal medicines in West Africa. Combining an evidence-based, ethnobotanical perspective with a pharmacological and pharmaceutical approach to phytomedicine, the book bridges the gap between the study of herbal plants' pharmacological properties and active compounds for the development of clinical drugs and community-oriented approaches, emphasising local use. It demonstrates how the framework of African traditional medicine can be preserved in a contemporary clinical context. The book outlines the history and beliefs surrounding the traditional use of herbs by the local population alongside their application in contemporary phytotherapy in Nigeria and West Africa. It features a critical assessment of the scientific rationale behind the use of these plants in ethnomedicine and offers a composite catalogue of phytotherapeutic and wellness agents, detailing the safety profile, efficacy, and scientific integrity of plants used to treat diseases and optimise health. Features: An ethnobotanical survey containing over 200 full-colour photographs of Nigerian and West African plants. A unique combination of ethnobotany and pharmacognosy, bridging the divide between pharmaceutical and community-oriented approaches to herbal medicine research. Contextual discussion of the therapeutic potential of Nigerian herbal medicine. Offers a template which can be used to separate the superstitious aspects of ethnomedicine from culturally inherited deposits of knowledge. A handbook for herbal and natural medicine practitioners, the book is aimed at African thinkers, scientists, healthcare providers and students of pharmacology and ethnomedicine.

This second edition presents methods and protocols to aid readers in the design and execution of experiments used to define critical elements associated with innate immune system function. New and updated chapters detail protocols on in vitro and ex vivo studies in key cell types associated with innate immunity and with in vivo protocols used to study immune system function in the mouse. Additionally, chapters describe methods to evaluate innate immune function and new protocols associated with autism, cancer, microfluidics platforms, and CRISPR systems. 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 easy to use, Mouse Models of Innate Immunity: Methods and Protocols, Second Edition will serve the research community by providing expert advice and protocols that allow both experienced and novice investigators to successfully plan, implement, and assess disease processes associated with the innate immune system.

This laboratory guidebook provides step-by-step procedures that will aid in the dissection and collection of major organs and tissues of the most common species of small animals used in biomedical research. Through extensive use of photographs and illustrations, the dissector is guided through a complete necropsy of each species for the purpose of collecting the organs and tissues routinely examined by pathologists. The techniques described will enable the technician to perform necropsies on almost any mammal in a precise and logical sequence, and to properly collect tissue in order to avoid diagnostic errors. Morphological differences among the various species are discussed.

Elastic Fiber Matrices: Biomimetic Approaches to Regeneration and Repair provides a comprehensive resource on the intrinsic and pathological aberrations of the complex process of elastic matrix assembly and/or variations thereof in different elastic tissue types, and on strategies to regenerate or restore lost elastin matrix, either in vitro or in vivo, including biomimetic elastin-like-peptides, gene therapy, drug delivery, tissue engineering (biomolecules, scaffolds, and mechanical stimuli), pharmacological approaches, elastin stabilization and preservation, stem cell therapy, allografts/xenografts, and synthetic/biological elastomers. Comprised of individual chapters contributed by leading researchers and scientists in the field, the text details current approaches for elastin matrix regeneration and repair, identifying their various advantages and limitations while offering valuable insight into emerging trends. Thus, this book is a must-have guide for academicians and industry professionals working in the areas of connective tissue biology, tissue engineering, dermal and cardiovascular biomaterials, and drug delivery.

Over the last several decades, bioethicists have championed a bewildering variety of methods for understanding and resolving difficult ethical problems in medicine, including: principlism, wide reflective equilibrium, casuistry, feminism, virtue theory, narrative, and others. Much of this advocacy overlooks the limitations of the favored method, and also neglects the strengths found in alternative approaches.
Tom Tomlinson systematically uncovers and evaluates both the strengths and limits of a variety of ethical tools, and in so doing develops a comprehensive appreciation of the roles that various methods can play in deepening our understanding of ethical problems in medicine, and in supporting well-grounded judgments about what to do. He critically evaluates each method to identify both limits and advantages, which he then illustrates through discussion of specific cases and controversies. Tomlinson not only demonstrates that there is no single method adequate to the task, but tries to develop an informed eclecticism that knows how to pick the right tool for the right job. All those engaged in thinking about bioethical theories will find Tomlinson's work important reading.

Guides You on the Development and Implementation of B-R Evaluations Benefit-Risk Assessment Methods in Medical Product Development: Bridging Qualitative and Quantitative Assessments provides general guidance and case studies to aid practitioners in selecting specific benefit-risk (B-R) frameworks and quantitative methods. Leading experts from industry, regulatory agencies, and academia present practical examples, lessons learned, and best practices that illustrate how to conduct structured B-R assessment in clinical development and regulatory submission. The first section of the book discusses the role of B-R assessments in medicine development and regulation, the need for both a common B-R framework and patient input into B-R decisions, and future directions. The second section focuses on legislative and regulatory policy initiatives as well as decisions made at the U.S. FDA's Center for Devices and Radiological Health. The third section examines key elements of B-R evaluations in a product's life cycle, such as uncertainty evaluation and quantification, quantifying patient B-R trade-off preferences, ways to identify subgroups with the best B-R profiles, and data sources used to assist B-R assessment. The fourth section equips practitioners with tools to conduct B-R evaluations, including assessment methodologies, a quantitative joint modeling and joint evaluation framework, and several visualization tools. The final section presents a rich collection of case studies. With top specialists sharing their in-depth knowledge, thought-provoking considerations, and practical advice, this book offers comprehensive coverage of B-R evaluation methods, tools, and case studies. It gives practitioners a much-needed toolkit to develop and conduct their own B-R evaluations.

The number of, and interest in, quality of life studies has grown dramatically in the last decade. On an ever increasing basis, patients, clinicians, researchers, and health policy regulators are considering quality of life in assessing treatment alternatives. Unfortunately, most discussions of quality of life are narrow in scope -- applying to only one disease group. This unique book represents the concerted effort of experts in academia, federal government health care regulators, and pharmaceutical industry representatives to define the promise and the problems associated with quality of life studies. The issues covered range from cross cutting ones to those that are specific to particular illnesses. Because quality of life takes into consideration such domains as mood, vocation, family, sexual functioning, social participation, and costs, this book will serve as an invaluable companion to readers with an interest in behavioral medicine research.

In longitudinal studies it is often of interest to investigate how a marker that is repeatedly measured in time is associated with a time to an event of interest, e.g., prostate cancer studies where longitudinal PSA level measurements are collected in conjunction with the time-to-recurrence. Joint Models for Longitudinal and Time-to-Event Data: With Applications in R provides a full treatment of random effects joint models for longitudinal and time-to-event outcomes that can be utilized to analyze such data. The content is primarily explanatory, focusing on applications of joint modeling, but sufficient mathematical details are provided to facilitate understanding of the key features of these models. All illustrations put forward can be implemented in the R programming language via the freely available package JM written by the author. All the R code used in the book is available at: http://jmr.r-forge.r-project.org/

Women's contributions to the field of medical research are a neglected but valuable part of human history not typically covered in general textbooks and historical volumes. While most laymen could recognize Florence Nightingale as the founder of modern nursing, it's doubtful they could likewise identify Louise Pearce as one of the primary researchers in the cure for African Sleeping Sickness or Anna W. Williams as the discoverer of the diphtheria antitoxin. This book profiles 25 women who have made significant contributions to medical research, including Lady Mary Wortley Montagu, Lydia Folger Fowler, Virginia Apgar, and Rosalind Franklin, among others. Each profile includes a general introduction and covers the woman's childhood or family background, her formal education, her most valuable contributions to the field, and the important events or persons which influenced her life and career. The book concludes with brief descriptions of important persons mentioned within the profiles.

"I am most excited and impressed with the scope and focus of this work. As I began to read it, I had trouble putting it down. It is highly readable, engaging, all-inclusive, and most informative."
Jean Watson, RN, PhD, HNC, FAAN

"I am honored and delighted to recommend this text for all nurses who cared for and care about patients."
from the Foreword by May Wykle, RN, PhD, FAAN

This book places comfort at the forefront of nursing care, by presenting a carefully researched theory of comfort that nurses can use as a framework for practice. Engagingly written, the book combines a first-person account of the development of the theory with supporting research, and practical information for its application. Kolcaba analyzes the concept of comfort; describes its physical, psychospiritual, environmental and sociocultural components; evaluates its meaning in the many different contexts in which health care occurs; and describes how it can be measured. The appendix includes comfort care questionnaires that can be used with patients in many settings, and a comfort scale that can be used with patients for a quick assessment of comfort. Clinicians, researchers, educators, and students will find this holistic approach helpful in setting priorities and parameters for patient care.
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Tony Seed, Gilbert Thompson, Jackie Downs and John MacDermot at the book's launch in LondonThis book brings together in one volume fifteen Nobel Prize-winning discoveries that have had the greatest impact upon medical science and the practice of medicine during the 20th century and up to the present time. Its overall aim is to enlighten, entertain and stimulate. This is especially so for those who are involved in or contemplating a career in medical research.Anyone interested in the particulars of a specific award or Laureate can obtain detailed information on the topic by accessing the Nobel Foundation's website. In contrast, this book aims to provide a less formal and more personal view of the science and scientists involved, by having prominent academics write a chapter each about a Nobel Prize-winning discovery in their own areas of interest and expertise.

This volume presents forty-two methods and protocols to analyze diverse aspects of genome instability. Chapters detail mutagenesis and repair, methods to quantify and analyze the properties of DNA double-strand breaks, profile replication, replication proteins strand-specifically, genome instability, fluorescence microscopic techniques, and genomic and proteomic approaches. 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 cutting-edge, Genome Instability: Methods and Protocols aims to provide a comprehensive resource for the discovery and analysis of the proteins and pathways that are critical for stable maintenance of the genome.

This book gives the pertinent information on the high pressure liquid chromatography (HPLC) analyses of all the compounds of interest in nucleic acid metabolism. It aids chromatographers, biochemists, biomedical researchers, and chemists by giving information on applications of HPLC technique.

This book serves as a practical guide and a manual on the application of isotopic tracers in understanding the cellular processes (e.g. molecular interactions, protein synthesis) in growth, development, and disease conditions. The techniques described in the book have been carefully chosen to underscore the role and relevance of isotopic tracers in the identification of molecular targets and mechanisms, and preclinical validation of potential therapeutics. This book is intended to be a valuable resource to non-experts that may include students, researchers, educators/teachers, and others who have an interest to understand the application of isotopic tracers in research. Each chapter includes a background, an outline of the method and underlying principles, and a detailed step-wise protocol. To augment the clarity and intellectual grasp, the chapters also include relevant illustrations and study questions. More importantly, the book covers techniques involving radioactive as well as non-radioactive tracers to expand the scope of isotopes in preclinical research including basic and applied science.

A Western-Based Approach to Analyzing TCMs In recent years, many pharmaceutical companies and clinical research organizations have been focusing on the development of traditional Chinese (herbal) medicines (TCMs) as alternatives to treating critical or life-threatening diseases and as pathways to personalized medicine. Quantitative Methods for Traditional Chinese Medicine Development is the first book entirely devoted to the design and analysis of TCM development from a Western perspective, i.e., evidence-based clinical research and development. The book provides not only a comprehensive summary of innovative quantitative methods for developing TCMs but also a useful desk reference for principal investigators involved in personalized medicine. Written by one of the world's most prominent biostatistics researchers, the book connects the pharmaceutical industry, regulatory agencies, and academia. It presents a state-of-the-art examination of the subject for: Scientists and researchers who are engaged in pharmaceutical/clinical research and development of TCMs Those in regulatory agencies who make decisions in the review and approval process of TCM regulatory submissions Biostatisticians who provide statistical support to assess clinical safety and effectiveness of TCMs and related issues regarding quality control and assurance as well as to test for consistency in the manufacturing processes for TCMs This book covers all of the statistical issues encountered at various stages of pharmaceutical/clinical development of a TCM. It explains regulatory requirements; product specifications and standards; and various statistical techniques for evaluation of TCMs, validation of diagnostic procedures, and testing consistency. It also contains an entire chapter of case studies and addresses critical issues in TCM development and FAQs from a

The popularity of germ-free animal models, particularly mice, for investigation of human physiology and disease has recently exploded. Gnotobiotic Mouse Technology: An Illustrated Guide provides the first manual for the maintenance, husbandry, and experimental manipulation of germ-free and gnotobiotic mice. It includes information on all aspects of establishing and operating a germ-free mouse research facility, from basic principles and equipment to detailed instructions for assembling and maintaining isolators, sterilizing supplies, handling animals, and monitoring sterility. The book breaks down techniques and procedures into modules, each of which contains a step-by-step practical and visual guide to a set of related procedures. Each description consists of a materials list, introduction, and general overview, followed by a thoroughly illustrated walkthrough of the steps for each procedure. The descriptions end with troubleshooting tips. Technical chapters are heavily illustrated and include notations of potential pitfalls and alternatives. Other chapters discuss management procedures and practices such as the hiring and training of personnel, setting fee schedules, and record keeping. This book is a landmark resource for establishing and maintaining a facility for germ-free mouse research. Useful to both technicians and investigators, it presents every step necessary to establish a successful facility. It also gives direction in expanding multi-user facilities and applying new technologies to your current practices.

Offers educators practical application of recent brain research through the Brain-Targeted Teaching Model an instructional framework that uses current brain research to guide teachers in planning, implementing, and evaluating instruction. This model will increase the potential of brain research to inform instructional strategies and to suggest ways to organize schools or design curriculum on a school-wide or district-wide basis. Features: . Description of brain anatomy . Current brain research findings . Suggestions to provide a supportive yet challenging emotional climate for learning . Highlights the important role the physical environment plays in learning . Ideas for enhancing instruction through organized and attractive classroom space . Stages of planning and implementing a learning unit Intended for classroom teachers at any grade level as well as those who support instruction in schools of higher education.

Discover the Latest Statistical Approaches for Modeling Exposure-Response Relationships Written by an applied statistician with extensive practical experience in drug development, Exposure-Response Modeling: Methods and Practical Implementation explores a wide range of topics in exposure-response modeling, from traditional pharmacokinetic-pharmacodynamic (PKPD) modeling to other areas in drug development and beyond. It incorporates numerous examples and software programs for implementing novel methods. The book describes using measurement error models to treat sequential modeling, fitting models with exposure and response driven by complex dynamics, and survival analysis with dynamic exposure history. It also covers Bayesian analysis and model-based Bayesian decision analysis, causal inference to eliminate confounding biases, and exposure-response modeling with response-dependent dose/treatment adjustments (dynamic treatment regimes) for personalized medicine and treatment adaptation. Many examples illustrate the use of exposure-response modeling in experimental toxicology, clinical pharmacology, epidemiology, and drug safety. Some examples demonstrate how to solve practical problems while others help with understanding concepts and evaluating the performance of new methods. The provided SAS and R codes enable readers to test the approaches in their own scenarios. Although application oriented, this book also gives a systematic treatment of concepts and methodology. Applied statisticians and modelers can find details on how to implement new approaches. Researchers can find topics for or applications of their work. In addition, students can see how complicated methodology and models are applied to practical situations.

How do we know whether a particular treatment really works? How reliable is the evidence? And how do we ensure that research into medical treatments best meets the needs of patients? These are just a few of the questions addressed in a lively and informative way in Testing Treatments. Brimming with vivid examples, Testing Treatments will inspire both patients and professionals. Building on the success of the first edition, Testing Treatments has now been extensively revised and updated. The Second Edition includes a thought-provoking chapter on screening, explaining why early diagnosis is not always better. Other new chapters explore how over-regulation of research can work against the best interests of patients, and how robust evidence from research can be drawn together to shape the practice of healthcare in ways that allow treatment decisions to be reached jointly by patients and clinicians. Testing Treatments urges everyone to get involved in improving current research and future treatment, and outlines practical steps that patients and doctors can take together.

Bringing together a team of leading international experts in the field of research, this book provides an up-to-date and accessible overview of applied research methods in the prehospital environment. Written to support the needs of the paramedicine, emergency medicine and wider healthcare communities in this rapidly advancing research setting, the authors introduce the key areas of research design and methods, evidence-based practice, ethics and quality improvement for both the novice and the more advanced researcher. Relevant examples of prehospital research are also included to fully explain and illustrate the key approaches. High-quality, robust evidence is of the utmost importance to inform prehospital clinical practice and ensure better patient care. This book is essential reading for anyone interested in undertaking research within the prehospital or emergency care setting, including undergraduate and postgraduate students in paramedic science, medicine, nursing and allied health.