Sharing Clinical Trial Data

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Publisher : National Academies Press
ISBN 13 : 0309316324
Total Pages : 236 pages
Book Rating : 4.3/5 (93 download)

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Book Synopsis Sharing Clinical Trial Data by : Institute of Medicine

Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.

Conflict of Interest in Medical Research, Education, and Practice

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Publisher : National Academies Press
ISBN 13 : 0309145449
Total Pages : 436 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Conflict of Interest in Medical Research, Education, and Practice by : Institute of Medicine

Download or read book Conflict of Interest in Medical Research, Education, and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-09-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.

Finding What Works in Health Care

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Publisher : National Academies Press
ISBN 13 : 0309164257
Total Pages : 267 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Finding What Works in Health Care by : Institute of Medicine

Download or read book Finding What Works in Health Care written by Institute of Medicine and published by National Academies Press. This book was released on 2011-07-20 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

Community-based Participatory Research

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Publisher :
ISBN 13 :
Total Pages : 8 pages
Book Rating : 4.:/5 (572 download)

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Book Synopsis Community-based Participatory Research by : United States. Agency for Healthcare Research and Quality

Download or read book Community-based Participatory Research written by United States. Agency for Healthcare Research and Quality and published by . This book was released on 2004 with total page 8 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Beyond the HIPAA Privacy Rule

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Publisher : National Academies Press
ISBN 13 : 0309124999
Total Pages : 334 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis Beyond the HIPAA Privacy Rule by : Institute of Medicine

Download or read book Beyond the HIPAA Privacy Rule written by Institute of Medicine and published by National Academies Press. This book was released on 2009-03-24 with total page 334 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the realm of health care, privacy protections are needed to preserve patients' dignity and prevent possible harms. Ten years ago, to address these concerns as well as set guidelines for ethical health research, Congress called for a set of federal standards now known as the HIPAA Privacy Rule. In its 2009 report, Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research, the Institute of Medicine's Committee on Health Research and the Privacy of Health Information concludes that the HIPAA Privacy Rule does not protect privacy as well as it should, and that it impedes important health research.

Designing Distributed Systems

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Publisher : "O'Reilly Media, Inc."
ISBN 13 : 1491983612
Total Pages : 164 pages
Book Rating : 4.4/5 (919 download)

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Book Synopsis Designing Distributed Systems by : Brendan Burns

Download or read book Designing Distributed Systems written by Brendan Burns and published by "O'Reilly Media, Inc.". This book was released on 2018-02-20 with total page 164 pages. Available in PDF, EPUB and Kindle. Book excerpt: Without established design patterns to guide them, developers have had to build distributed systems from scratch, and most of these systems are very unique indeed. Today, the increasing use of containers has paved the way for core distributed system patterns and reusable containerized components. This practical guide presents a collection of repeatable, generic patterns to help make the development of reliable distributed systems far more approachable and efficient. Author Brendan Burns—Director of Engineering at Microsoft Azure—demonstrates how you can adapt existing software design patterns for designing and building reliable distributed applications. Systems engineers and application developers will learn how these long-established patterns provide a common language and framework for dramatically increasing the quality of your system. Understand how patterns and reusable components enable the rapid development of reliable distributed systems Use the side-car, adapter, and ambassador patterns to split your application into a group of containers on a single machine Explore loosely coupled multi-node distributed patterns for replication, scaling, and communication between the components Learn distributed system patterns for large-scale batch data processing covering work-queues, event-based processing, and coordinated workflows

Registries for Evaluating Patient Outcomes

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Publisher : Government Printing Office
ISBN 13 : 1587634333
Total Pages : 385 pages
Book Rating : 4.5/5 (876 download)

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Book Synopsis Registries for Evaluating Patient Outcomes by : Agency for Healthcare Research and Quality/AHRQ

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Bad Pharma

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Publisher : Macmillan
ISBN 13 : 0865478066
Total Pages : 479 pages
Book Rating : 4.8/5 (654 download)

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Book Synopsis Bad Pharma by : Ben Goldacre

Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.

The Belmont Report

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Publisher :
ISBN 13 :
Total Pages : 614 pages
Book Rating : 4.:/5 (327 download)

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Book Synopsis The Belmont Report by : United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

Download or read book The Belmont Report written by United States. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and published by . This book was released on 1978 with total page 614 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Mobile Usability

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Publisher : Pearson Education
ISBN 13 : 0133122174
Total Pages : 596 pages
Book Rating : 4.1/5 (331 download)

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Book Synopsis Mobile Usability by : Jakob Nielsen

Download or read book Mobile Usability written by Jakob Nielsen and published by Pearson Education. This book was released on 2012-10-09 with total page 596 pages. Available in PDF, EPUB and Kindle. Book excerpt: How do we create a satisfactory user experience when limited to a small device? This new guide focuses on usability for mobile devices, primarily smartphones and touchphones, and covers such topics as developing a mobile strategy, designing for small screens, writing for mobile, usability comparisons, and looking toward the future. The book includes 228-full color illustrations to demonstrate the points. Based on expert reviews and international studies with participants ranging from students to early technology adopters and business people using websites on a variety of mobile devices, this guide offers a complete look at the landscape for a mobile world. Author Jakob Nielsen is considered one of the world's leading experts on Web usability. He is the author of numerous best-selling books, including Prioritizing Web Usability and the groundbreaking Designing Web Usability, which has sold more than 250,000 copies and has been translated in 22 languages.

Framework for Determining Research Gaps During Systematic Review

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Author :
Publisher : Createspace Independent Pub
ISBN 13 : 9781483944296
Total Pages : 70 pages
Book Rating : 4.9/5 (442 download)

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Book Synopsis Framework for Determining Research Gaps During Systematic Review by : U. S. Department of Health and Human Services

Download or read book Framework for Determining Research Gaps During Systematic Review written by U. S. Department of Health and Human Services and published by Createspace Independent Pub. This book was released on 2013-03-23 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt: The identification of gaps from systematic reviews is essential to the practice of ''evidence-based research.'' Health care research should begin and end with a systematic review. A comprehensive and explicit consideration of the existing evidence is necessary for the identification and development of an unanswered and answerable question, for the design of a study most likely to answer that question, and for the interpretation of the results of the study. In a systematic review, the consideration of existing evidence often highlights important areas where deficiencies in information limit our ability to make decisions. We define a research gap as a topic or area for which missing or inadequate information limits the ability of reviewers to reach a conclusion for a given question. A research gap may be further developed, such as through stakeholder engagement in prioritization, into research needs. Research needs are those areas where the gaps in the evidence limit decision making by patients, clinicians, and policy makers. A research gap may not be a research need if filling the gap would not be of use to stakeholders that make decisions in health care. The clear and explicit identification of research gaps is a necessary step in developing a research agenda. Evidence reports produced by Evidence-based Practice Centers (EPCs) have always included a future research section. However, in contrast to the explicit and transparent steps taken in the completion of a systematic review, there has not been a systematic process for the identification of research gaps. We developed a framework to systematically identify research gaps from systematic reviews. This framework facilitates the classification of where the current evidence falls short and why the evidence falls short. The framework included two elements: (1) the characterization the gaps and (2) the identification and classification of the reason(s) for the research gap. The PICOS structure (Population, Intervention, Comparison, Outcome and Setting) was used in this framework to describe questions or parts of questions inadequately addressed by the evidence synthesized in the systematic review. The issue of timing, sometimes included as PICOTS, was considered separately for Intervention, Comparison, and Outcome. The PICOS elements were the only sort of framework we had identified in an audit of existing methods for the identification of gaps used by EPCs and other related organizations (i.e., health technology assessment organizations). We chose to use this structure as it is one familiar to EPCs, and others, in developing questions. It is not only important to identify research gaps but also to determine how the evidence falls short, in order to maximally inform researchers, policy makers, and funders on the types of questions that need to be addressed and the types of studies needed to address these questions. Thus, the second element of the framework was the classification of the reasons for the existence of a research gap. For each research gap, the reason(s) that most preclude conclusions from being made in the systematic review is chosen by the review team completing the framework. To leverage work already being completed by review teams, we mapped the reasons for research gaps to concepts from commonly used evidence grading systems. Our objective in this project was to complete two types of further evaluation: (1) application of the framework across a larger sample of existing systematic reviews in different topic areas, and (2) implementation of the framework by EPCs. These two objectives were used to evaluate the framework and instructions for usability and to evaluate the application of the framework by others, outside of our EPC, including as part of the process of completing an EPC report. Our overall goal was to produce a revised framework with guidance that could be used by EPCs to explicitly identify research gaps from systematic reviews.

Relieving Pain in America

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Publisher : National Academies Press
ISBN 13 : 030921484X
Total Pages : 383 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Relieving Pain in America by : Institute of Medicine

Download or read book Relieving Pain in America written by Institute of Medicine and published by National Academies Press. This book was released on 2011-10-26 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chronic pain costs the nation up to $635 billion each year in medical treatment and lost productivity. The 2010 Patient Protection and Affordable Care Act required the Department of Health and Human Services (HHS) to enlist the Institute of Medicine (IOM) in examining pain as a public health problem. In this report, the IOM offers a blueprint for action in transforming prevention, care, education, and research, with the goal of providing relief for people with pain in America. To reach the vast multitude of people with various types of pain, the nation must adopt a population-level prevention and management strategy. The IOM recommends that HHS develop a comprehensive plan with specific goals, actions, and timeframes. Better data are needed to help shape efforts, especially on the groups of people currently underdiagnosed and undertreated, and the IOM encourages federal and state agencies and private organizations to accelerate the collection of data on pain incidence, prevalence, and treatments. Because pain varies from patient to patient, healthcare providers should increasingly aim at tailoring pain care to each person's experience, and self-management of pain should be promoted. In addition, because there are major gaps in knowledge about pain across health care and society alike, the IOM recommends that federal agencies and other stakeholders redesign education programs to bridge these gaps. Pain is a major driver for visits to physicians, a major reason for taking medications, a major cause of disability, and a key factor in quality of life and productivity. Given the burden of pain in human lives, dollars, and social consequences, relieving pain should be a national priority.

NTP Toxicity Study Reports

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Author :
Publisher :
ISBN 13 :
Total Pages : 56 pages
Book Rating : 4.:/5 (4 download)

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Book Synopsis NTP Toxicity Study Reports by :

Download or read book NTP Toxicity Study Reports written by and published by . This book was released on 1991 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Discipline-Based Education Research

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Publisher : National Academies Press
ISBN 13 : 0309254140
Total Pages : 282 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Discipline-Based Education Research by : National Research Council

Download or read book Discipline-Based Education Research written by National Research Council and published by National Academies Press. This book was released on 2012-08-27 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: The National Science Foundation funded a synthesis study on the status, contributions, and future direction of discipline-based education research (DBER) in physics, biological sciences, geosciences, and chemistry. DBER combines knowledge of teaching and learning with deep knowledge of discipline-specific science content. It describes the discipline-specific difficulties learners face and the specialized intellectual and instructional resources that can facilitate student understanding. Discipline-Based Education Research is based on a 30-month study built on two workshops held in 2008 to explore evidence on promising practices in undergraduate science, technology, engineering, and mathematics (STEM) education. This book asks questions that are essential to advancing DBER and broadening its impact on undergraduate science teaching and learning. The book provides empirical research on undergraduate teaching and learning in the sciences, explores the extent to which this research currently influences undergraduate instruction, and identifies the intellectual and material resources required to further develop DBER. Discipline-Based Education Research provides guidance for future DBER research. In addition, the findings and recommendations of this report may invite, if not assist, post-secondary institutions to increase interest and research activity in DBER and improve its quality and usefulness across all natural science disciples, as well as guide instruction and assessment across natural science courses to improve student learning. The book brings greater focus to issues of student attrition in the natural sciences that are related to the quality of instruction. Discipline-Based Education Research will be of interest to educators, policy makers, researchers, scholars, decision makers in universities, government agencies, curriculum developers, research sponsors, and education advocacy groups.

How People Learn

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Publisher : National Academies Press
ISBN 13 : 0309131979
Total Pages : 386 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis How People Learn by : National Research Council

Download or read book How People Learn written by National Research Council and published by National Academies Press. This book was released on 2000-08-11 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: First released in the Spring of 1999, How People Learn has been expanded to show how the theories and insights from the original book can translate into actions and practice, now making a real connection between classroom activities and learning behavior. This edition includes far-reaching suggestions for research that could increase the impact that classroom teaching has on actual learning. Like the original edition, this book offers exciting new research about the mind and the brain that provides answers to a number of compelling questions. When do infants begin to learn? How do experts learn and how is this different from non-experts? What can teachers and schools do-with curricula, classroom settings, and teaching methodsâ€"to help children learn most effectively? New evidence from many branches of science has significantly added to our understanding of what it means to know, from the neural processes that occur during learning to the influence of culture on what people see and absorb. How People Learn examines these findings and their implications for what we teach, how we teach it, and how we assess what our children learn. The book uses exemplary teaching to illustrate how approaches based on what we now know result in in-depth learning. This new knowledge calls into question concepts and practices firmly entrenched in our current education system. Topics include: How learning actually changes the physical structure of the brain. How existing knowledge affects what people notice and how they learn. What the thought processes of experts tell us about how to teach. The amazing learning potential of infants. The relationship of classroom learning and everyday settings of community and workplace. Learning needs and opportunities for teachers. A realistic look at the role of technology in education.

The Health Effects of Cannabis and Cannabinoids

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Publisher : National Academies Press
ISBN 13 : 0309453070
Total Pages : 487 pages
Book Rating : 4.3/5 (94 download)

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Book Synopsis The Health Effects of Cannabis and Cannabinoids by : National Academies of Sciences, Engineering, and Medicine

Download or read book The Health Effects of Cannabis and Cannabinoids written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2017-03-31 with total page 487 pages. Available in PDF, EPUB and Kindle. Book excerpt: Significant changes have taken place in the policy landscape surrounding cannabis legalization, production, and use. During the past 20 years, 25 states and the District of Columbia have legalized cannabis and/or cannabidiol (a component of cannabis) for medical conditions or retail sales at the state level and 4 states have legalized both the medical and recreational use of cannabis. These landmark changes in policy have impacted cannabis use patterns and perceived levels of risk. However, despite this changing landscape, evidence regarding the short- and long-term health effects of cannabis use remains elusive. While a myriad of studies have examined cannabis use in all its various forms, often these research conclusions are not appropriately synthesized, translated for, or communicated to policy makers, health care providers, state health officials, or other stakeholders who have been charged with influencing and enacting policies, procedures, and laws related to cannabis use. Unlike other controlled substances such as alcohol or tobacco, no accepted standards for safe use or appropriate dose are available to help guide individuals as they make choices regarding the issues of if, when, where, and how to use cannabis safely and, in regard to therapeutic uses, effectively. Shifting public sentiment, conflicting and impeded scientific research, and legislative battles have fueled the debate about what, if any, harms or benefits can be attributed to the use of cannabis or its derivatives, and this lack of aggregated knowledge has broad public health implications. The Health Effects of Cannabis and Cannabinoids provides a comprehensive review of scientific evidence related to the health effects and potential therapeutic benefits of cannabis. This report provides a research agendaâ€"outlining gaps in current knowledge and opportunities for providing additional insight into these issuesâ€"that summarizes and prioritizes pressing research needs.

MURA Summer Study Reports on Design and Utilization of High-energy Accelerators

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Author :
Publisher :
ISBN 13 :
Total Pages : 424 pages
Book Rating : 4.3/5 (91 download)

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Book Synopsis MURA Summer Study Reports on Design and Utilization of High-energy Accelerators by : Midwestern Universities Research Association

Download or read book MURA Summer Study Reports on Design and Utilization of High-energy Accelerators written by Midwestern Universities Research Association and published by . This book was released on 1959 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: