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1

Bürki, Christoph. Verwaltungsjustizbezogene Legalität und Prozessökonomie: Eine Untersuchung zum Verhältnis gerichtsorganisations- und verfahrensbezogener Gesetzmässigkeit und Prozesswirtschaftlichkeit unter Berücksichtigung der Verhältnisse im Bund und im Kanton Bern. Bern: Stämpfli Verlag, 2011.

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Page, David E. Valerie and the jelly bean trail. St. Petersburg, Fla: Willowisp Press, 1995.

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3

Musson, Nellie Eileen. A Bermuda trail blazer: The legendary Marjorie Louise Bean. Bermuda: Published in cooperation with the Business and Professional Women's Association of Bermuda (BPWA), an affiliate of the International Federation of Business and Professional Women (IFBPW), 1986.

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Deen, Ron. On the trail of Sawney Bean and his cannibal family. Glasgow: R. Deen, 1995.

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5

Bernhardt, William. Dark justice. New York: Ballantine Books, 1999.

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6

Bernhardt, William. Dark justice. New York: Ballantine Pub., 1999.

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7

Bernhardt, William. Naked justice. New York: Ballantine Books, 1997.

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8

Bernhardt, William. Capitol murder. New York: Random House Large Print, 2006.

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9

Bernhardt, William. Capitol Murder. New York: Random House Publishing Group, 2006.

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10

Bernhardt, William. Capitol murder: A novel. New York: Ballantine Books, 2006.

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11

J, Lumsden Diana, and Massachusetts Continuing Legal Education, Inc. (1982- ), eds. Litigating women's health cases: How to work up one of these cases--which cases have been successful and why. Boston, MA (10 Winter Pl., Boston 02108-4751): MCLE, 1993.

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Bernhardt, William. Extreme justice. New York: Ballantine Books, 1998.

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Bernhardt, William. Naked justice. England: Niagara, 1997.

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14

Olaru, Stejărel. Cei cinci care au speriat Estul: Atacul asupra Legației RPR de la Berna (februarie 1955). Iași: Polirom, 2003.

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15

Richter zwischen den Fronten: Die Urteile des Berner Prozesses um die "Protokolle der Weisen von Zion" 1933-1937. Basel: Helbing Lichtenhahn, 2011.

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16

Timothy Hooks Chtm Cres CBET and Asiya Morris. Jelly Bean Trail. BookBaby, 2021.

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17

Hooks, Timothy, and Assiya Morris. Jelly Bean Trail. BookBaby, 2021.

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18

Tobin, Martin J. Assessment and technique of weaning. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199600830.003.0102.

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Several studies suggest that most patients weaned successfully could have tolerated the weaning attempts had they been initiated a day or so earlier. Such data emphasize the need for the early use of screening tests. A screening test should have a high sensitivity. The ratio of respiratory frequency to tidal volume has been evaluated in more than 25 studies and its average sensitivity is 0.89. Weaning involves undertaking three diagnostic tests in sequence, measuring predictors, a weaning trial, and a trial of extubation. Of the techniques used for a weaning trial, intermittent mandatory ventilation has been repeatedly shown to be inferior to the use of T-tube trials or pressure support. Six randomized trials have evaluated the usefulness of protocols in the management of weaning. Three revealed no benefit—two had major methodological problems, leaving only one supporting the use of protocols.
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19

Belknap, Michal R. American Political Trials. 2nd ed. Greenwood Publishing Group, Inc., 1994. http://dx.doi.org/10.5040/9798400611537.

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An updated and expanded revision of a popular book published in 1981, American Political Trials examines the role of politicized criminal trials and impeachments in U.S. history from the early colonial era to the late 20th century. Each chapter focuses on a trial representative of a particular era in the American past. The emphasis is on cases that resulted from political persecution, but the book also shows how defendants have exploited the judicial process to advance their political objectives. All of the chapters appearing in the earlier book have been updated. In addition, the volume includes new chapters on the 1637 trial of Anne Hutchinson and the 1989 trial of Lt. Col. Oliver North for his role in the Iran-Contra scandal. The book also includes an updated bibliographical essay.
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20

Kulkarni, Kunal, James Harrison, Mohamed Baguneid, and Bernard Prendergast, eds. Oxford Handbook of Key Clinical Evidence. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780198729426.001.0001.

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Key trials have been selected for their relevance to clinical practice, allowing the reader to quickly access some of the most fundamental issues that influence their day-to-day activities. The Handbook covers all major medical and surgical specialties, with a new section on paediatrics added for the second edition. Introductory chapters have been included on the development of evidence-based medicine, giving uninitiated readers the tools required to critically analyse and understand medical studies. Complex trials have been distilled to key relevant facts, for quick reference and understanding. This is a comprehensive one-stop shop for medical students, trainees, and clinicians of all levels that presents key information for a selection of seminal evidence that has informed medical and surgical practice. Readers are introduced to the statistical methods and tools needed to critically analyse trial data, providing a key for the terms and statistical methods encountered in the book and within clinical research as a whole. Leading figures in the major specialties have selected and summarized some of the most important trials, while analysis of the key message and impact of the trial firmly places the evidence into a practical setting for the reader. Key study features and results are examined, while the difficulties or problems associated with the trials are outlined.
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21

Inc, Ideals Publications. Peter Cottontail on the Jelly Bean Trail. Ideals Publications, 1988.

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22

Talkington, J. A. Been There, Done That: Leave a Trail. Collaborative Medical Research Publishers, 2020.

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23

Kafka, Franz, and Isabel Tucker. Trial: Someone Must Have Been Telling Lies about Josef K. Arcturus Publishing, 2020.

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24

Grant, Robert. Tumours of the brain and skull. Oxford University Press, 2011. http://dx.doi.org/10.1093/med/9780198569381.003.0624.

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Over the last 10 years, there have been several important advances in cell biology, molecular genetics, and targeted therapies in neuro-oncology. Improved neurosurgical techniques such as frameless stereotaxy, awake craniotomy, and intra-operative MRI, safer methods of directing radiotherapy, new chemotherapy approaches, and novel modalities of therapy provide optimism that there will eventually be some improvements in treatment-related morbidity and survival. There has also been an increasing change from individual clinician decision making to decision making by multidisciplinary teams of neurosurgeons, neurologists, clinical oncologists, neuropathologists, neuroradiologists, and specialist nurses with the aim of improving decision making, management planning across specialties, communication, and enrolment in suitable clinical trials. In addition, Good Clinical Practice guidelines, an international ethical and scientific quality standard for designing, conducting, recording, and reporting trials, increases the onus and responsibilities on clinical investigators to perform trials to the highest standard and to have the trials externally monitored, and the trial conduct and results audited. While these obligatory and statutory responsibilities are labour intensive and time consuming, they should improve the quality of trials by limiting the possibility of unintentional bias or fraud. Improving the recording of serious adverse event reporting through trial quality assurance and quality control procedures will help ensure that a balanced view of the effects of a drug or procedure is identified earlier than in the past. It will be interesting to see how research develops over the next decade.
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25

Inde, Vilis R. Art in the Courtroom. Greenwood Publishing Group, Inc., 1998. http://dx.doi.org/10.5040/9798400614576.

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Providing legal analysis and touching upon social history and art history themes, this work offers an objective review of five art trials. Spanning the last 20 years, specific areas of law are examined with each trial: First and Fifth Amendments, copyright law, contract law, valuation of art, and misrepresentation. Art, outside of the legal vacuum, has been embroiled in a battle initiated by social conservatives to promote decency. Three trials involving this struggle and the National Endowment of the Arts are analyzed. The valuation of art is examined in the context of Andy Warhol's estate and copyright law is considered because of the appropriation of contemporary images by Jeff Koons. Although each trial is reviewed distinctly, all are interwoven to present major issues relating to contemporary art. Entertaining aspects of each trial contribute to the understanding of art and law. For art students, copyright, contract and constitutional analysis in the context of actual hearings is an invaluable resource outlining afforded protections and options. To scholars interested in contemporary art and its encounters with the law, this text bridges the gap between two seemingly disparate worlds.
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26

Maher, Gerry. Unfitness for Trial in Scots Law. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780198788478.003.0005.

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The plea of unfitness for trial in Scots law advances the goal of ensuring that criminal trials should not proceed against anyone whose mental or physical condition makes it unsuitable for them to be subject to such a process. This chapter traces the development of the common law version of the plea, namely insanity in bar trial. It then examines more recent reforms, which considered the plea in the context of human rights and comparative law. These reforms have resulted in statutory formulation of the three key issues, namely the test or definition of the plea, the procedures to be used in determining the existence of the plea in a particular case, and the disposal options appropriate for people who have been found to be unfit for trial.
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27

Borch, Fred L. Preparing for Trial. Oxford University Press, 2017. http://dx.doi.org/10.1093/oso/9780198777168.003.0005.

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Netherlands East Indies authorities faced a number of obstacles in preparing for trial. Many Japanese nationals who had committed war crimes in the Indies were no longer available. Some were dead, some were missing (whereabouts unknown), some had already been repatriated to Japan and consequently were beyond the reach of the Dutch. Of the Japanese who were in custody, it was not easy to build a prosecution case. Memories fade over time and persons who had been victims in 1942 were not always able to identify their assailants. Language barriers (the Dutch and Eurasian victims did not speak, much less understand, Japanese) meant that the victims often did not know the name of the person who had harmed them. This chapter looks at the practical problems faced by the Dutch in prosecuting war crimes.
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28

Kulkarni, Kunal, James Harrison, Mohamed Baguneid, and Bernard Prendergast, eds. Cardiology. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780198729426.003.0003.

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To date, several thousand randomized trials of cardiac treatments have been published, and, over the past few decades, clinical cardiology has gradually evolved from an experience-based to an evidence-based specialty. This chapter focuses on familiarizing clinicians with some of the evidence underpinning contemporary cardiological practice and encourages interest in the future development of the cardiological evidence base. Using an eclectic selection and providing a balanced interpretation of trial results, it takes trials that have influenced cardiological practice, covering topics such as the optimal treatment of hypertension, non-ST elevation acute coronary syndrome, and heart failure.
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29

Moghalu, Kingsley Chiedu. Global Justice. Praeger, 2006. http://dx.doi.org/10.5040/9798400657535.

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After a controversial war in which he was ousted and captured by United States forces, Saddam Hussein was arraigned before a war crimes tribunal. Slobodan Milosevic died midway through his contentious trial by an international war crimes tribunal at The Hague. Calls for intervention and war crimes trials for the massacres and rapes in Sudan's Darfur region have been loud and clear, and the United States remains fiercely opposed to the permanent International Criminal Court. Are war crimes trials impartial, apolitical forums? Has international justice for war crimes become an entrenched aspect of globalization? InGlobal Justice, Moghalu examines the phenomenon of war crimes trials from an unusual, political perspective—that of an anarchical international society. After a controversial war in which he was ousted and captured by United States forces, Saddam Hussein was arraigned before a war crimes tribunal. Slobodan Milosevic died midway through his contentious trial by an international war crimes tribunal at The Hague. Calls for intervention and war crimes trials for the massacres and rapes in Sudan's Darfur region have been loud and clear, and the United States remains fiercely opposed to the permanent International Criminal Court. Are war crimes trials impartial, apolitical forums? Has international justice for war crimes become an entrenched aspect of globalization? InGlobal Justice, Moghalu examines the phenomenon of war crimes trials from an unusual, political perspective—that of an anarchical international society. He argues that, contrary to conventional wisdom, war crimes trials are neither motivated nor influenced solely by abstract notions of justice. Instead, war crimes trials are the product of the interplay of political forces that have led to an inevitable clash between globalization and sovereignty on the sensitive question of who should judge war criminals. From Germany's Kaiser Wilhelm to the Japanese Emperor Hirohito, from the trials of Milosevic, Saddam Hussein, and Charles Taylor to Belgium's attempts to enforce the contested doctrine of universal jurisdiction, Moghalu renders a compelling tour de force of one of the most controversial subjects in world politics. He argues that, necessary though it was, international justice has run into a crisis of legitimacy. While international trials will remain a policy option, local or regional responses to mass atrocities will prove more durable.
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30

Hammer, Espen, ed. Kafka's The Trial. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780190461454.001.0001.

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The Trial, written from 1914 to 1915 and published in 1925, is a multifaceted, notoriously difficult manifestation of European literary modernism. Written in a relatively abstract language, it tells the story of Josef K., who is accused of a crime he has no recollection of having committed (and whose nature is never revealed to him). The novel has often been interpreted theologically, expressing a form of radical nihilism in a modern world abandoned by God. However, it has just as often been read as a parable of the cold, inhumane rationality of modern bureaucratization. Like many other novels of this turbulent period, it offers a tragic quest-narrative in which the hero’s search for truth and clarity (about himself, his alleged guilt, and the anonymous system he is facing) progressively leads to greater and greater confusion, ending with his execution. In this volume, the contributors deal with a range of issues arising in this work. Theology is central, and related to that are questions of justice, law, ethics, resistance, and subjectivity. All the contributors view the novel as responding to a context of rapid modernization, and questions of metaphysics intersect with the most mundane challenges of everyday life. There is here a fundamental uncertainty, a context of skepticism, that the contributors approach from a variety of angles.
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31

Kulkarni, Kunal, James Harrison, Mohamed Baguneid, and Bernard Prendergast, eds. Plastic and reconstructive surgery. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780198729426.003.0029.

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In plastic and reconstructive surgery, innovation and creativity have been foremost, with science and evidence following. Unlike for a number of other specialties, the advances in plastic surgery have largely come from imagination, innovations, and trial and error, rather than from scientific trials. Somewhat more than for the rest of surgery, in plastics (where the art and craft of each particular surgeon counts immeasurably), randomized controlled trials of techniques have failed to be generated in the past, due to the difficulty of objectively assessing the success of surgery with an aesthetic-based nature. Consequently, evidence-based study of plastic surgery is a relatively new and developing field. This chapter focuses on the growing importance of evidence-based surgery in this specialty, showing that scientific trials are now being performed with increasing frequency.
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32

Williams, G. Trials And Tribulations: All The Things I've Been Throug. Authorhouse, 2005.

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33

Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2013. http://dx.doi.org/10.1093/med/9780199642489.003.0030.

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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, 'first-in-human' to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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34

Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_001.

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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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35

Strand, Vibeke, Jeremy Sokolove, and Alvina D. Chu. Design of clinical trials in rheumatology. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199642489.003.0030_update_002.

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Development of new therapies for rheumatic diseases requires a series of randomized controlled trials (RCTs) progressing from phase 1, ’first-in-human’ to generate initial safety, pharmacokinetic (PK) and pharmacodynamic (PD) data; to phase 2, proof of concept for efficacy with safety and PK/PD data; and phase 3, designed to demonstrate definitive efficacy and safety to support regulatory approval. Important aspects of RCT designs include sample size estimations, treatment allocation, rescue, blinding, and statistical analyses of prespecified endpoints to preserve trial integrity. Over the past 15 years, significant progress has been made in the design of RCTs in rheumatoid arthritis (RA). Similarly, development and validation of composite outcome measures in psoriatic arthritis, ankylosing spondylitis, gout, and osteoarthritis have furthered trial design and treatment approvals. RCTs in systemic lupus erythematosus and other multisystem, heterogeneous diseases pose more challenges. Trial design will continue to evolve as promising therapies are introduced into the clinic.
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36

Boyd, Tristan, and Arthur Kavanaugh. Biologic DMARDs (TNF inhibitors). Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780198737582.003.0029.

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Tumor necrosis factor-α‎ inhibitors (TNFi) can effectively treat all domains of disease in patients with psoriatic arthritis (PsA). They have been shown to be effective and also generally safe and well tolerated in numerous clinical trials. This chapter reviews clinical trial evidence for the efficacy and safety of TNFi in PsA and highlights evidence-based treatment recommendations for their use. Emerging treatment strategies involving the use of TNFi in the management of PsA are also discussed.
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37

Gordon, Michael. ADHD on Trial. Praeger Publishers, 2009. http://dx.doi.org/10.5040/9798400606885.

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In 2006 Philadelphia, graduate student Jonathan Love sued the organization that publishes the Law School Admissions Test. Love had attained average scores on the test, but claimed he should have been given extra time because he qualified as a person with a disability - and allowances provided by the Americans with Disabilities Act - due to Attention Deficit Hyperactivity Disorder. The case, which drew in author psychologist Michael Gordon as an expert witness for the defense, reached federal court and resulted in a precedent-setting ruling still as controversial as the disorder that triggered the trial. In this work, Gordon takes us into the courtroom and behind the scenes with attorneys and experts to look not only at this trial, but more than a dozen others that have involved ADHD or other psychiatric diagnoses, and the questions they raise, including what the real meaning of disability is, how malingering can be an issue with psychological disorders, and what the more far-reaching effects for the public can be if accommodations are provided to people who do not have a legally-defined disability. When does deference to an individual with a disorder like ADHD begin to invade the rights of the non-disabled? Controversy fills these pages, from discussion of ADHD and the debate over its justifiability as a disability to public reactions regarding the ruling in Love's case and others. Comparisons and contrasts are also raised between the Love trial and earlier cases involving people claiming psychological disabilities who fought actions by The National Board of Medical Examiners, United Airlines, Toyota Motor Manufacturing, the Georgia State Board of Veterinary Medicine, and other organizations. Do the decisions help or harm disability rights and people with disabilities? Gordon offers the insights not only of a psychologist, but a seasoned legal insider who has testified as an expert witness at many of the trials.
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38

Waldrep, Christopher. Racial Violence on Trial. ABC-CLIO, 2001. http://dx.doi.org/10.5040/9798216004288.

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An examination of the historical experience of African Americans as a case study of America's legacy of racial violence. In this comprehensive overview of how the law has been used to combat racism, author Christopher Waldrep points out that the U.S. government has often promoted discrimination. A veritable history of civil rights, the story is told primarily through a discussion of key legal cases. Racial Violence on Trialalso presents 11 key documents gathered together for the first time, from the Supreme court's opinion inBrown v. Mississippito a 1941 newspaper account entitled The South Kills Another Negro, to a 1947New Yorkerpiece, Opera in Greenville, about a crowd of taxi drivers who killed a black man. Also included are a listing of key people, laws, and concepts; a chronology; a table of cases; and an annotated bibliography.
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39

Copenhaver, Brian P. Pico della Mirandola on Trial. Oxford University Press, 2022. http://dx.doi.org/10.1093/oso/9780192858375.001.0001.

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Giovanni Pico della Mirandola (1463–94) has been a beacon of progress in modern times, and the celebrated Oration on the Dignity of Man has been the engine of his fame. But he never wrote a speech about the dignity of man. The prince’s speech announced quite different projects: persuading Christians to become Kabbalists in order to annihilate themselves in God; and convincing philosophers that their path to saving wisdom was concord rather than disputation. This book about Heresy, Freedom, and Philosophy shows that Pico’s work, before and after he wrote the Oration, was in no way progressive—or ‘humanist’—in its ideas, and that his main authorities were medieval clerics and theologians, not secular Renaissance intellectuals. The evidence is Pico’s Apology, his self-defense against heresy charges: this public polemic reveals more about him than the famous speech that he never gave and that deliberately kept its message secret. The orator’s method in the Oration was esoteric, but the defendant in the Apology made his case openly in a voice that was academic and belligerent, not prophetic or poetic. Perhaps because of its size and presentation, the Apology has been read less than Pico’s other writings: as far as I know, the last book devoted entirely to it appeared more than five centuries ago.
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40

Lei, Peng, Scott Ayton, and Ashley I. Bush. Metal-Protein Attenuating Compounds in Neurodegenerative Diseases. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780190233563.003.0015.

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Neurodegenerative disorders including Alzheimer’s (AD), Parkinson’s disease (PD), Huntington’s disease (HD), and amyotrophic lateral sclerosis (ALS) are progressive diseases of the aging population with currently few therapeutic options. While aggregation and deposition of disease-specific proteins link the pathologies of these diseases, targeting these aggregating proteins with therapeutics has not yet been successful in clinical trial. This chapter profiles metals (copper, zinc, and iron) as alternative drug targets for neurodegeneration. Complex changes to metals occur in these neurodegenerative diseases. Accumulating evidences have demonstrated that perturbations to metal homeostasis contribute to the progression of neuronal dysfunction and death. Importantly, several phase II trials have shown that correcting metal dyshomeostasis improves clinical outcomes; the chapter argues that it is now time to explore the therapeutic utility of metal-based drugs in larger, phase III trials.
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41

Moore, Randy. The Scopes “Monkey Trial”. Praeger, 2022. http://dx.doi.org/10.5040/9798216183556.

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"This book introduces readers to the "b-9798216183556-0000001"Trial of the Century,"b-9798216183556-0000001" revealing how the trial originated, what caused and happened during and after the trial, what happened to the trial's participants, and why the trial still matters nearly 100 years later. Ongoing controversies about school curricula, such as the teaching of Critical Race Theory and the role of parents in public education, can all be traced to the Scopes Trial. Today, the question remains: who controls the school curriculum? This was a foundational issue in the Scopes Trial, and we have been debating this question ever since. This book will help readers understand where these controversies originated and how courts, politicians, and the public handled these issues nearly a century ago. Featuring new information from previously untapped sources and providing an in-depth study of John Scopes himself, this book interrogates the facts, fictions, and legend of the Scopes Trial, which historians rank as one of the defining events of the 20th century. It is an ideal resource for anyone interested in the ongoing controversy about evolution, science, and religion in education and American life."
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42

Cummings, Jeffrey L., and Kate Zhong. Clinical Trials and Drug Development in Neurodegenerative Diseases. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780190233563.003.0018.

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This chapter describes the common therapeutic targets, approaches to clinical trial design, biomarkers, and therapeutic interventions across neurodegenerative disorders (NDDs). Each unique NDD-Alzheimer’s disease (AD), Parkinson’s disease (PD), amyotrophic lateral sclerosis (ALS), etc.-has a unique phenotype associated with the regional cell population most affected. Each disease, however, is associated with protein misfolding, oxidation, inflammation, apoptosis, and cell death. If vulnerable cell populations include transmitter source nuclei, transmitter deficits also emerge (e.g. cholinergic abnormalities in AD and dopaminergic deficits in PD). Biomarkers show regionally appropriate brain atrophy or process-related cerebrospinal deficits. Clinical trial designs share features for symptomatic interventions (e.g. cholinesterase inhibitors in AD and dopamine agents in PD) and disease-modifying therapies. Biomarkers play similar roles in trials for NDD, including demonstrating target engagement and supporting disease modification. No disease-modifying therapies have been approved for any NDDs; all programs face similar pharmacokinetic, pharmacodynamic, and regulatory challenges in therapeutic development.
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43

Villen : First Offense: Trials and Testimony of a Has-Been Wannabe. Independent Publisher, 2021.

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44

Lambdin, Bill, Alien Buddha, and Red Focks. Left on the Trail Where I've Been: Selected Poems 1993-2013. Independently Published, 2019.

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45

Le vittime di Giovanni Calvino: Valentino Gentile, eretico antitrinitario, decapitato a Berna nel 1566. Reggio Calabria: Città del sole edizioni, 2020.

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46

Geissler, P. Wenzel, and Catherine Molyneux, eds. Evidence, Ethos, Experiment: The Anthropology and History of Medical Research in Africa. Berghahn Books, 2011. http://dx.doi.org/10.3167/9780857450920.

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Medical research has been central to biomedicine in Africa for over a century, and Africa, along with other tropical areas, has been crucial to the development of medical science. At present, study populations in Africa participate in an increasing number of medical research projects and clinical trials, run by both public institutions and private companies. Global debates about the politics and ethics of this research are growing and local concerns are prompting calls for social studies of the “trial communities” produced by this scientific work. Drawing on rich, ethnographic and historiographic material, this volume represents the emergent field of anthropological inquiry that links Africanist ethnography to recent concerns with science, the state, and the culture of late capitalism in Africa.
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47

Shapiro, Benjamin. Ibogaine: History, Pharmacology, Spirituality, & Clinical Data. Edited by Shahla J. Modir and George E. Muñoz. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190275334.003.0027.

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Ibogaine is an indole alkaloid derived from the African shrub Tabernathe iboga with broad anti-addictive, anti-depressant, and central nervous system stimulating effects. It is categorized as an oneriogen (or atypical hallucinogen) and has been used in West African tribal rituals for centuries. It was identified by French explorers in the early 1900s, came to the United States in the 1960s, and became marginalized in the mid-1990s after adverse outcomes halted federally funded human trials. Since then legal ibogaine treatment clinics have been established in countries without use restrictions. Ibogaine is a σ‎1 and σ‎2 receptor and μ‎ and κ‎ opioid receptor agonist and a α‎3β‎4 nicotinic and NMDA receptor antagonist. Decades of trials have demonstrated ibogaine’s potential. Human trials of ibogaine consistently demonstrate rapid remission of acute withdrawal symptoms but differ in their findings with regard to abstinence and toxicity. While ibogaine is not a “magic bullet,” considerable abstinence may result after multiple treatments, however QT prolongation can produce lethal ventricular tachyarrhythmias.18 MC is in pre-clinical investigation.
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48

Håkan, Friman. Part V Fairness and Expeditiousness of ICC Proceedings, 36 Trial Procedures—With a Particular Focus on the Relationship between the Proceedings of the Pre-Trial and Trial Chambers. Oxford University Press, 2015. http://dx.doi.org/10.1093/law/9780198705161.003.0036.

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The length of proceedings before the ICC has been an issue of concern. ICC proceedings at pre-trial and trial have been slow and can be improved. Based on a study of existing cases (e.g. Lubanga, Katanga and Ngudjolo Chui), this chapter highlights some areas that deserve closer review, in particular, consistency and coordination between the Pre-Trial and Trial Chambers, both of which are engaged in trial preparations. The chapter shows that the current combination of the two procedural stages is dysfunctional, and argues that the centre of gravity in criminal proceedings should be the first-instance trial, while the confirmation hearing should be seen as a supplementary process. The space of the Pre-Trial Chamber to prepare trial by resolving issues of disclosure, redactions, or admissibility of evidence is rather limited.
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49

Ray, Sumantra (Shumone), Sue Fitzpatrick, Rajna Golubic, Susan Fisher, and Sarah Gibbings, eds. Clinical trial protocols: study protocol. Oxford University Press, 2016. http://dx.doi.org/10.1093/med/9780199608478.003.0015.

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This chapter defines protocols and the requirements to be considered when writing a protocol, The protocol is one of the most important documents and must be clear, concise and well written. The chapter describes the procedures before embarking on writing a protocol, who should be involved and describes all the main elements to be included. The ICH E6 guidelines give a complete list of the content of a protocol so this chapter centres on the main decisions/considerations. The main considerations are outlined in a skeleton protocol which includes for example objectives and end points, subject population, study design, study methodology, assessments and timings and statistical considerations. Once these main decisions have been made the first full draft protocol can be written by elaborating every detail and adding the administrative sections as set out in the company/institution SOPs and the ICH GCP guidelines. The process of protocol approval is described along with the requirements for protocol amendments. The additional requirements to be considered in writing protocols for healthcare studies is set out especially the ethical requirements that have to be addressed.
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50

Villen : First Offense: The Trials and Testimony of a Has-Been Wannabe. Independent Publisher, 2021.

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