For academic medical faculty unfamiliar with national and international regulations, the prospect of initiating and managing a clinical trial can be intimidating. The development of protocols and case report forms, compliance with regulatory requirements, the monitoring of clinical trials as well as the responsibilities of documentation are just some of the tasks the sponsor-investigator is faced with. This book covers the entire spectrum of a clinical trial, reviewing the different stages step by step: financial planning, crucial aspects of trial design, the authorization process and, finally, documentation. Moreover, it contains helpful tips, a practical glossary, instructions and a large number of resources related to the relevant regulations and forms conforming to the ‘International Conference on Harmonization and Good Clinical Practice’. This makes the publication at hand an essential ‘cookbook’ for both academic faculty new to clinical trials as well as seasoned sponsors-investigators.
In 1933 Paul Klee’s work was branded as ‘Entartete Kunst’ (Degenerate Art) by the National Socialists and he was dismissed from his professorial post at the Düsseldorf Academy of Fine Arts. This led him, together with his wife Lily, to return to his ‘real home’ of Bern. Here his avant-garde art was not understood and Klee found himself in unasked for isolation. In 1935 Klee started to suffer from a mysterious disease. The symptoms included changes to the skin and problems with the internal organs. In 1940 Paul Klee died, but it was only 10 years after his death that the illness was actually given the name ‘scleroderma’ in a publication about Klee. However, the diagnosis remained mere conjecture. Since his adolescence, the dermatologist and venereologist Dr. Hans Suter has been fascinated by Paul Klee and his art, and more than 30 years ago this fascination spurred him to commence research into the illness and its influence on the art of Paul Klee’s final years. It was due to Dr. Suter’s meticulous investigations that Klee’s illness could be defined as ‘diffuse systemic sclerosis’. In this book the author assembles his findings and describes the rare and complex disease in a clear and comprehensible way. Further, he empathetically interprets more than 90 of Klee’s late works. The point of view of a dermatologist renders a unique source of information. It provides, on one hand, new insights into everyday medical practices at the University of Bern in the 1930s, which will fascinate doctors and local historians alike. While, on the other hand, art historians and art lovers will be absorbed by the newly discovered links between Paul Klee's work and his illness.
In the last few years, impressive research has been done on disorders of sex development (DSD), largely expanding the physiopathology with relevant effects on practice. Thus, management of individuals with DSD requires updated scientific knowledge, integrating basic and clinical information. In addition, doctors involved in the care of individuals with DSD need to develop specific personal skills in communication, ethics, legal issues and the ability to work together in dedicated multidisciplinary teams. National or even international networks are also mandatory to create stringent structures for correctly addressing the care of individuals with DSD and to offer them a better long-term outcome. This special issue of Sexual Development covers several of these hot topics and highlights some aspects of research and management. A special paper from a patient support group has been enclosed to present the opinion of affected people. All the authors have been selected regarding their expertise and documented competencies.
The symptom of chronic constipation is often caused by a series of intestinal diseases, which can be reliably diagnosed histopathologically by histochemical techniques and consequently treated by surgical intervention. The following publication is the second and completely revised edition of 'Pathology of Chronic Constipation in Pediatric and Adult Coloproctology' published in 2005, and introduces several new diseases and figures. It includes characteristics of classical and ultrashort Hirschsprung’s disease as well as total intestinal aganglionosis and hypoganglionosis. New diseases such as intestinal neuronal dysplasia, desmosis coli, leiomyopathy, architectural malformation, and stretching lesions of muscularis propria are critically discussed. Atrophic desmosis is also covered. This new and frequently observed degeneration of muscularis propria in Crohn’s disease, sigmoid diverticulitis, and other inflammatory intestinal diseases causes focal aperistalsis, frequently interpreted as scar stenosis. 'Histopathology of Chronic Constipation' provides a comprehensive overview of intestinal alterations which cause chronic constipation. It is therefore of special interest to diagnostic pathologists, clinicians, pediatric and abdominal surgeons, coloproctologists, and gastroenterologists.
This is a work of advocacy, whose prime objective is to inform people about the relationship between nutrition security and public health. It draws on the thinking and experience of a selected number of experts in the field of nutrition and public health. Collating up-to-the-minute information in a clear and accessible way, the book forms a ‘one-stop information source’, and paves the way for further, science-led publications in this field. ‘The Road to Good Nutrition’ puts the topic of nutrition security on the agenda of policy-makers, academics, private sector organizations and civil society, as well as of organizations dedicated to the nutrition space. It is also of interest to the educated lay reader who is generally well informed in matters of health, nutrition and sustainability.
Modern medicine is now in a position to make advanced prognoses that chart the entire course of illness and recovery. Paradoxically, this is coupled with a new dimension of uncertainty for the patient, i.e. coming to terms with discovering they have an increased risk of a particular disease and deciding what appropriate steps to take. In this publication, renowned experts in their fields discuss these issues. The certainty and uncertainty of one’s fate are discussed from both methodological and epidemiological perspectives, using examples of diseases for which treatment and prognosis have dramatically changed. Despite profound insights into the human genome, personalized genetically tailored medicine still lies in the future. Religious, spiritual and philosophical dimensions are discussed, as are the ways in which they may help people cope with these new insights into their future, e.g. the promise of an afterlife. This publication aims to bridge the different fields dealing with this area by addressing the challenges faced and encouraging dialogue. It will be of interest to all readers who deal with ethical problems of prognosis, particularly in medicine, as well as to theologians and sociologists.
In this unique volume, leading international experts share their experiences in the management of head and neck tumors, providing a guidebook for all surgeons dealing with head and neck neoplasms. Each chapter offers a concise description of useful 'pearls' and dangerous 'pitfalls' which must be avoided. Contributions cover topics from thyroid glands, neck metastases, and oral tumors to laryngeal, pharyngeal, and nasopharyngeal tumors, as well as salivary gland tumors, skull base tumors, and reconstruction surgery. In addition to frequent diseases which are encountered in everyday practice, some new therapeutic topics such as video-assisted thyroidectomy, robotic surgery, and management of the neck after organ preservation treatment are discussed. The 2nd edition has been extended by topical chapters of major practical interest including the latest findings and techniques. The new chapters are clearly indicated and can be recognized easily.
Light therapy' is established worldwide as the treatment of choice for seasonal affective disorder. It is also successfuly used in nonseasonal depression, as well as for many other psychiatric and neurologic illnesses, and in sleep medicine. ‘Wake therapy’ is the fastest antidepressant known. Imaging studies show that both methods share neurobiological substrates with antidepressants, but act much faster. 'Chronotherapeutics' – the combination of light and wake therapy – achieves rapid results and, by reducing residual symptoms, also minimises relapse. Written by three prominent clinical and research experts in biological rhythms, this manual aims to broaden knowledge and practical application of these non-pharmacologic interventions for bipolar and unipolar disorders. Clinical understanding is deepened by an explanation of the circadian timing system and sleep regulatory mechanisms which underlie the novel treatment strategy. The step-by-step guide and description of the interventions in centers throughout the world provides clear hands-on instructions, supported by a solid body of clinical research.
The first edition of 'Chronotherapeutics for Affective Disorders' has kindled a network of psychiatrists and psychologists who are actively introducing these treatments for their inpatients and outpatients. This manual is also essential reading for primary care physicians, sleep medicine specialists and health care administrators.