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Klinische Prüfungen mit Arzneimitteln in der Schwangerschaft

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ISBN: 9783863952334 Year: DOI: 10.17875/gup2015-885 Language: German
Publisher: Universitätsverlag Göttingen
Subject: Law
Added to DOAB on : 2016-06-21 11:02:28
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The clinical trial on medicinal products stands in the area of conflict between important scientific progress in favour of future patients on the one hand and the necessary protection of human subjects on the other hand. This conflict grows more acute when vulnerable persons – like pregnant women – are included in medical research. Whereas there are specific regulations for minors or incapacitated persons in the German Medicinal Products Act, legal regulations for the inclusion of pregnant women are missing. Based on this uncertain legal situation solutions are developed, which will show a way out of the dilemma. Insofar as the applicable law does not provide a handle for this problem, a need for reform is shown.

Towards translating research to clinical practice: Novel Strategies for Discovery and Validation of Biomarkers for Brain Injury

Authors: --- --- --- --- et al.
Book Series: Frontiers Research Topics ISSN: 16648714 ISBN: 9782889193912 Year: Pages: 178 DOI: 10.3389/978-2-88919-391-2 Language: English
Publisher: Frontiers Media SA
Subject: Medicine (General) --- Neurology
Added to DOAB on : 2015-12-03 13:02:24
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Traumatic brain injury (TBI) is a major cause of death and disability and one of the greatest unmet needs in medicine and public health. TBI not only has devastating effects on patients and their relatives but results in huge direct and indirect costs to society. Although guidelines for the management of patients have been developed and more than 200 clinical trials have been conducted, they have resulted in few improvements in clinical outcomes and no effective therapies approved for TBI. It is now apparent that the heterogeneity of clinical TBI is underlain by molecular phenotypes more complex and interactive than initially conceived and current approaches to the characterization, management and outcome prediction of TBI are antiquated, unidimensional and inadequate to capture the interindividual pathophysiological heterogeneity. Recent advances in proteomics and biomarker development provide unparalleled opportunities for unraveling substantial injury-specific and patient-specific variability and refining disease characterization. The identification of novel, sensitive, objective tools, referred to as biomarkers, can revolutionize pathophysiological insights, enable targeted therapies and personalized approaches to clinical management. In this Research Topic, we present novel approaches that provide an infrastructure for discovery and validation of new biomarkers of acute brain injury. These techniques include refined mass spectrometry technology and high throughput immunoblot techniques. Output from these approaches can identify potential candidate biomarkers employing systems biology and data mining methods. In this Research Topic, we present novel approaches that provide an infrastructure for discovery and validation of new biomarkers of acute brain injury. These techniques include refined mass spectrometry technology and high throughput immunoblot techniques. Output from these approaches can identify potential candidate biomarkers employing systems biology and data mining methods. Finally, suggestions are provided for the way forward, with an emphasis on need for a multidimensional approach that integrate a panel of pathobiologically diverse biomarkers with clinical variables and imaging-based assessments to improve diagnosis and classification of TBI and to develop best clinical practice guidelines.

New treatment perspectives in autism spectrum disorders

Authors: ---
Book Series: Frontiers Research Topics ISSN: 16648714 ISBN: 9782889195305 Year: Pages: 161 DOI: 10.3389/978-2-88919-530-5 Language: English
Publisher: Frontiers Media SA
Subject: Pediatrics --- Medicine (General)
Added to DOAB on : 2015-12-10 11:59:06
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Developing novel and more effective treatments that improve quality of life for individuals with autism spectrum disorders is urgently needed. To date a wide range of behavioral interventions have been shown to be safe and effective for improving language and cognition and adaptive behavior in children and adolescents with ASD. However many people with ASD can receive additional benefit from targeted pharmacological interventions. One of the major drawback in setting up therapeutics intervention is the remarkable individual differences found across individuals with ASD. As a matter of fact the medications that are currently available address only symptoms associated with ASD and not the core domains of social and communication dysfunction. The pathogenesis paradigm shift of ASD towards synaptic abnormalities moved the research to pathway to disease that involve multiple systems and that are becoming the forefront of ASD treatment and are pointing toward the development of new targeted treatments. Some new therapeutics have been tested and others are being studied. In this context single gene disorders frequently associated with ASD such as Rett Syndrome, Fragile X and Tuberous Sclerosis have been of significant aid as neurobiology of these disorders is more clear and has a potential to shed light on the altered signaling in ASD. However much research is needed to further understand the basic mechanisms of disease and the relationship to idiopathic ASD. Clinical trials in children are underway with agents directed to core symptoms and to the associated disorders in the search of new therapeutics and progress are expected with possible new option for therapeutics in ASD in the upcoming future. Children and Adolescents with ASD and their families can provide important information about their experience with new treatments and this should be a priority for future research. In addition, research performed on genetic mouse models of ASD will keep on providing useful information on the molecular pathways disrupted in the disease, thus contributing to identify novel drug targets.

Sekundärnutzung klinischer Daten – Rechtliche Rahmenbedingungen

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ISBN: 9783954661428 9783954663224 Year: Language: German
Publisher: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft Grant: Knowledge Unlatched - 104963
Subject: Internal medicine
Added to DOAB on : 2020-02-15 11:21:04
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Zunehmend greift medizinische Forschung auf Daten aus der Versorgung zurück. Diese ‚Sekundärnutzung‘ von Behandlungsdaten bringt jedoch zahlreiche Rechtsfragen mit sich. Sozial- und Gesundheitsdaten gehören zu den intimsten Informationen über einen Menschen. Mit dem vorliegenden Rechtsgutachten steht erstmals eine detaillierte Übersicht über die spezifischen rechtlichen Rahmenbedingungen für die Sekundärnutzung medizinischer Daten in den einzelnen Bundesländern zur Verfügung, die auch jeweils die unterschiedliche Trägerschaft und Rechtsform der behandelnden Institution berücksichtigt. Die Analyse gibt Forschern und anderen Akteuren im Gesundheitsbereich Orientierung beim rechtskonformen Umgang mit medizinischen Behandlungsdaten. Das Buch enthält darüber hinaus ein ergänzendes Gutachten, das die rechtlichen Rahmenbedingungen für die Sekundärnutzung der über die elektronische Gesundheitskarte nach § 291a SGB V verwalteten Daten darstellt.

Leitfaden zum Datenschutz in medizinischen Forschungsprojekten

Authors: --- --- ---
ISBN: 9783954661237 9783954662951 Year: Language: German
Publisher: MWV Medizinisch Wissenschaftliche Verlagsgesellschaft Grant: Knowledge Unlatched - 104962
Subject: Internal medicine
Added to DOAB on : 2020-02-15 11:21:04
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Das Vertrauen von Patienten und Probanden ist eine unverzichtbare Voraussetzung für den Erfolg medizinischer Forschungsprojekte, die ohne die Erhebung, langfristige Speicherung und Analyse von klinischen Daten und Proben nicht durchgeführt werden können. Medizinische Forschung arbeitet heute überwiegend vernetzt in zunehmend größeren Forschungsverbünden. Entsprechend nimmt auch die Bedeutung von Datenschutz und Datensicherheit immer weiter zu. Die TMF hat bereits 2003 erstmals generische Datenschutzkonzepte für medizinische Forschungsverbünde veröffentlicht. Auf dieser Basis konnten zahlreiche Forschungsprojekte ihre Datenschutzkonzepte schneller erarbeiten und abstimmen. Die dabei gewonnenen Erfahrungen sind in die grundlegende Überarbeitung der generischen Konzepte eingeflossen. So trägt das neue Konzept der Vielschichtigkeit medizinischer Forschungsprozesse durch einen modularen Aufbau Rechnung und wurde zudem in einen umfassenden Leitfaden eingebettet.

Preclinical and clinical issues in Alzheimer's disease drug research and development

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Book Series: Frontiers Research Topics ISSN: 16648714 ISBN: 9782889194339 Year: Pages: 100 DOI: 10.3389/978-2-88919-433-9 Language: English
Publisher: Frontiers Media SA
Subject: Therapeutics --- Science (General)
Added to DOAB on : 2016-01-19 14:05:46
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Alzheimer’s disease (AD) is a chronic neurodegenerative disorder characterized by progressive cognitive dysfunction and memory loss, inability to perform the activities of daily living and mood disorders. According to the so-called “amyloid cascade hypothesis”, amyloid-ß- peptide (Aß), produced by beta- and gamma- secretase-mediated cleavages of the amyloid precursor protein (APP), plays a pivotal role in the pathogenesis of AD. Aß was also shown to contribute to AD pathology by stimulating the hyperphosphorylation of tau which is responsible for the formation of neurofibrillary tangles. However, the “amyloid cascade hypothesis” was challenged by other theories which lend support to the idea that Aß is not causative but can be considered as an “innocent bystander” in AD. Although preclinical research generated impressive lines of evidence about the several intracellular mechanism(s) whose impairment leads to the onset and progression of AD, clinical research aimed at the development of new drugs capable of preventing or delaying the onset of neuronal damage in AD patients has produced limited results. The drugs currently available for the treatment of AD are acetylcholinesterase inhibitors (AChEI) and the NMDA glutamate receptor antagonist memantine. The AChEI increase acetylcholine levels in the synaptic cleft, which are reduced because of the progressive damage of cholinergic neurons in cognitive brain areas (e.g. amygdala, hippocampus, and frontal cortex), whereas memantine is used to prevent/reduce calcium-dependent excitotoxic neuronal cell death. Both classes of drugs have been shown to improve symptoms related to cognitive decline, but their effects are confined largely to patients with mild to moderate AD, in particular during the first year or so of treatment. An alternative to this symptomatic treatments involves the use of drugs that intervene in the pathogenesis of the disease. Recently, monoclonal antibodies against Aß were proposed as novel agents capable to remove Aß from the brain thus preventing neuronal damage. The research topic focuses on the preclinical and clinical evidence about the several factors that contribute to the pathogenesis of AD as well as the potential therapeutic role of new classes of drugs still under preclinical or clinical development.

Tuberculosis in Adults and Children

Authors: --- --- ---
Book Series: SpringerBriefs in Public Health ISBN: 9783319191317 9783319191324 Year: Pages: 66 DOI: 10.1007/978-3-319-19132-4 Language: English
Publisher: Springer Nature Grant: Wellcome Trust - 089276
Subject: Internal medicine
Added to DOAB on : 2016-03-15 10:53:40
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This work contains updated and clinically relevant information about tuberculosis. It is aimed at providing a succinct overview of history and disease epidemiology, clinical presentation and the most recent scientific developments in the field of tuberculosis research, with an emphasis on diagnosis and treatment. It may serve as a practical resource for students, clinicians and researchers who work in the field of infectious diseases.

Novel clinical applications of extracellular vesicles

Authors: --- ---
Book Series: Frontiers Research Topics ISSN: 16648714 ISBN: 9782889196456 Year: Pages: 66 DOI: 10.3389/978-2-88919-645-6 Language: English
Publisher: Frontiers Media SA
Subject: Medicine (General) --- Allergy and Immunology
Added to DOAB on : 2016-08-16 10:34:25
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During the last years, the research on extracellular vesicles (EVs) has raised giving new insights into pathophysiology of several diseases. EVs are membrane-bound particles secreted by almost all cell types. Depending on their biogenesis and size they include exosomes, microparticles / microvesicles and apoptotic bodies. Characteristically, EVs carry markers from the source cell membrane and contain genetic material, lipids and proteins inside. They are known to play a role in cell-to-cell communication and to produce genotypic and phenotypic modifications in the target cell including: antigen presentation, apoptosis induction, cellular activation, inhibition or differentiation. In particular, increasing concentrations of EVs have been found in many diseases such as cancer, autoimmune and cardiovascular diseases, among others. Most of the studies in EVs are focused on the characterization of EVs compounds, identifying mechanism of action, their potential use as biomarkers, and few of them investigate a therapeutic usage. However, there are some issues to be achieved on the path to their clinical application. This research topic offers a common place to discuss current and novel clinical applications of EVs pointing on future directions. We encouraged the submission of original articles, reviews, hypothesis, controversies, future perspectives and personal viewpoints on the following topics of interest, but not limited to: • Contribution of EVs to better understand the pathology of immunological diseases. • Standardization of isolation and quantification protocols in the daily clinical practice. • Possible applications of EVs as clinical biomarkers (diagnostic, prognostic and evolution marker). • Therapeutic role of EVs being vehicles of specific cargo: current clinical trials? • Novel immunological functions of EVs.

Therapeutic Implications of Circadian Rhythms

Authors: --- ---
Book Series: Frontiers Research Topics ISSN: 16648714 ISBN: 9782889196654 Year: Pages: 96 DOI: 10.3389/978-2-88919-665-4 Language: English
Publisher: Frontiers Media SA
Subject: Science (General) --- Therapeutics
Added to DOAB on : 2016-08-16 10:34:25
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Circadian rhythms are biological processes displaying endogenous and entrainable oscillations of about 24 hours. They are driven by a group of genes called clock genes that have been widely observed in plants, animals and even in bacteria. In mammals, the core clock genes are rhythmically expressed in both the suprachiasmatic nucleus (SCN), the master clock residing in the hypothalamus, and almost all peripheral tissues where they control numerous target genes in a circadian manner, and thus affect many physiological and biochemical processes. Evidence suggests that disruption of the circadian rhythms (or desynchronization) is a significant risk factor for the development of metabolic diseases, cardiovascular diseases, cancer and sleep disorders. Evidence also suggests that the disruption suppresses immune function and increases vulnerability to infectious diseases. Restoring or strengthening the circadian rhythm may be therapeutic for these conditions. This becomes exceptionally important in modern societies because many people are suffering from frequent desynchronization due to shift working, exposure to artificial light, travel by transmeridian air flight, and involvement in social activities. Besides, the temporal variations in the incidence and severity of many diseases, such as the onset of cardiovascular events, chronic obstructive pulmonary disease (COPD), inflammatory diseases and mental disorders have also drawn increasing attention to the circadian clock. The circadian rhythms affect not only the health status, but also the drug efficiency. The effects (and side effects) of many drugs vary with biological timing. The tolerance of many medications displays circadian variation as well. The timing of medical treatment in coordination with the body clock may significantly increase the desired effects of drugs, and lower the dose and toxicity. In addition, circadian rhythms can also be modulated by some therapeutic drugs, for example, melatonin and modafinil, which are used to treat circadian rhythm sleep disorders. In this Research Topic, we assemble a series of critical review and research articles that focus on the therapeutic implications of circadian rhythms. Topics include, but are not limited to: • Circadian disruption caused diseases or disorders and related intervention • Temporal manifestation of diseases or disorders and therapeutic implications • The effects of circadian rhythms on drugs • The effects of drugs on circadian rhythms

Epidemiology (Book chapter)

Book title: Tuberculosis in Adults and Children

Authors: --- --- ---
Book Series: SpringerBriefs in Public Health ISBN: 9783319191317 9783319191324 Year: Pages: 66 Language: English
Publisher: Springer Nature Grant: Wellcome Trust - 089276
Subject: Internal medicine
Added to DOAB on : 2019-01-15 13:34:46

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This work contains updated and clinically relevant information about tuberculosis. It is aimed at providing a succinct overview of history and disease epidemiology, clinical presentation and the most recent scientific developments in the field of tuberculosis research, with an emphasis on diagnosis and treatment. It may serve as a practical resource for students, clinicians and researchers who work in the field of infectious diseases.

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