Substantial Risk Reporting — Industrial Requirements

2020 ◽  
pp. 143-153
Author(s):  
George Dominguez
Keyword(s):  
Substantial Risk ◽  
Risk Reporting

Ischemic Complications of Pregnancy: Who is at Risk?

2016 ◽  
Vol 10 (1) ◽  
pp. 14
Author(s):  
Sara C Martinez ◽  
◽  
Sharonne N Hayes ◽  
Keyword(s):  
Artery Dissection ◽  
Cardiac Events ◽  
Coronary Artery Dissection ◽  
Reduction Strategies ◽  
Ischemic Complications ◽  
Substantial Risk ◽  
History Of ◽  
Invasive Management ◽  
In Pregnancy

The physiologic demands of pregnancy may either trigger or uncover ischemic heart disease (IHD) via largely unknown mechanisms, leading to an increased mortality compared with nonpregnant individuals. Risk factors for IHD in pregnancy are age, smoking, multiparity, and prior cardiac events. A multidisciplinary team at a referral center is key to coordinating medical or invasive management and inpatient observation. Etiologies may be revealed by experienced angiographers, and are predominantly spontaneous coronary artery dissection, followed by atherosclerotic disease and thrombus, while a significant percentage of women are found to have normal coronary arteries by angiogram. The management of these conditions is varied and, in general, conservative management is preferred with adequate coronary flow and stable hemodynamics. A woman with a history of IHD in pregnancy is at a substantial risk for further complications in future pregnancies and beyond; therefore, aggressive risk factor-reduction strategies and regular cardiology follow-up are imperative to decrease adverse events.

Long- versus short-term androgen deprivation therapy with high-dose radiotherapy for biochemical failure after radical prostatectomy: a randomized controlled trial

2020 ◽  
Vol 16 (27) ◽  
pp. 2035-2044
Author(s):  
Charlien Berghen ◽  
Steven Joniau ◽  
Annouschka Laenen ◽  
Gaetan Devos ◽  
Kato Rans ◽  
...  
Keyword(s):  
Radical Prostatectomy ◽  
Androgen Deprivation Therapy ◽  
Controlled Trial ◽  
Locally Advanced ◽  
Lymph Node Involvement ◽  
Androgen Deprivation ◽  
High Dose ◽  
Open Label ◽  
Clinical Trial Registration ◽  
Substantial Risk

Radical prostatectomy is a well-established treatment option in the management of localized and locally advanced prostate cancer. An extended lymphadenectomy is performed in case of substantial risk for lymph node involvement. When biochemical recurrence (BCR) occurs, salvage radiotherapy (SRT) is performed. The benefit in terms of BCR-free survival (FS) and metastasis-FS by adding 6 months of androgen deprivation therapy (ADT) compared with SRT only has already been established. Retrospective evidence suggests that a longer schedule of ADT may be more beneficial compared with 6 months. This multicenter open-label randomized trial will include patients who need SRT after experiencing BCR post-radical prostatectomy with lymphadenectomy and pN0-status. Patients will be randomized for ADT duration (6 vs 24 months). Primary end point is distant metastasis-FS. Clinical Trial Registration: NCT04242017 ( ClinicalTrials.gov )

scholarly journals Development and design of the Hantavirus registry - HantaReg - for epidemiological studies, outbreaks and clinical studies on hantavirus disease

2021 ◽  
Author(s):  
Felix C Koehler ◽  
Linda Blomberg ◽  
Thomas Theo Brehm ◽  
Stefan Büttner ◽  
Oliver A Cornely ◽  
...  
Keyword(s):  
Data Entry ◽  
Scoring Systems ◽  
Epidemiological Studies ◽  
Incidence Rates ◽  
Case Report Form ◽  
Treatment Pathways ◽  
General Data Protection Regulation ◽  
The World ◽  
Electronic Case Report Form ◽  
Substantial Risk

Abstract Background Frequent outbreaks around the globe and endemic appearance in different parts of the world emphasize the substantial risk of hantavirus diseases. Increasing incidence rates, trends of changing distribution of hantavirus species and new insights into clinical courses of hantavirus diseases call for multinational surveillance. Furthermore, evidence-based guidelines for the management of hantavirus diseases and scoring systems, which allow stratification of patients into risk categories, are lacking. Methods Hantavirus registry (HantaReg) is a novel registry platform facilitating multinational research of hantavirus-caused diseases, such as haemorrhagic fever with renal syndrome (HFRS) and hantavirus cardiopulmonary syndrome (HCPS). HantaReg provides an electronic case report form and uses the General Data Protection Regulation compliant platform clinicalsurveys.net, which can be accessed from any internet browser in the world. Having a modular structure, the registry platform is designed to display or hide questions and items according to the documented case (e.g. patient with HFRS versus HCPS) to facilitate fast, but standardized, data entry. Information categories documented in HantaReg are demographics, pre-existing diseases, clinical presentation, diagnostic and therapeutic approaches, as well as outcome. Conclusions HantaReg is a novel, ready-to-use platform for clinical and epidemiological studies on hantavirus diseases and facilitates the documentation of the disease course associated with hantavirus infections. HantaReg is expected to promote international collaboration and contributes to improving patient care through the analysis of diagnostic and treatment pathways for hantavirus diseases, providing evidence for robust treatment recommendations. Moreover, HantaReg enables the development of prognosis-indicating scoring systems for patients with hantavirus disease.

scholarly journals The Evolving Landscape of the Molecular Epidemiology of Malignant Pleural Mesothelioma

2021 ◽  
Vol 10 (5) ◽  
pp. 1034
Author(s):  
Sara Lettieri ◽  
Chandra Bortolotto ◽  
Francesco Agustoni ◽  
Filippo Lococo ◽  
Andrea Lancia ◽  
...  
Keyword(s):  
Molecular Epidemiology ◽  
Malignant Pleural Mesothelioma ◽  
Strong Association ◽  
Pleural Mesothelioma ◽  
The European Union ◽  
Long Latency ◽  
Substantial Risk ◽  
Novel Biomarkers ◽  
Definition Of ◽  
Novel Concept

Malignant pleural mesothelioma (MPM) is a rare and aggressive malignancy that most commonly affects the pleural lining of the lungs. It has a strong association with exposure to biopersistent fibers, mainly asbestos (80% of cases) and—in specific geographic regions—erionite, zeolites, ophiolites, and fluoro-edenite. Individuals with a chronic exposure to asbestos generally have a long latency with no or few symptoms. Then, when patients do become symptomatic, they present with advanced disease and a worse overall survival (about 13/15 months). The fibers from industrial production not only pose a substantial risk to workers, but also to their relatives and to the surrounding community. Modern targeted therapies that have shown benefit in other human tumors have thus far failed in MPM. Overall, MPM has been listed as orphan disease by the European Union. However, molecular high-throughput profiling is currently unveiling novel biomarkers and actionable targets. We here discuss the natural evolution, mainly focusing on the novel concept of molecular epidemiology. The application of innovative endpoints, quantification of genetic damages, and definition of genetic susceptibility are reviewed, with the ultimate goal to point out new tools for screening of exposed subject and for designing more efficient diagnostic and therapeutic strategies.

Diplomatic Assurances Against Torture – An Effective Strategy? A Review of Jurisprudence and Examination of the Arguments

2008 ◽  
Vol 77 (4) ◽  
pp. 319-364 ◽  
Author(s):  
Lena Skoglund
Keyword(s):  
Human Rights ◽  
International Law ◽  
War On Terror ◽  
The State ◽  
Security Threats ◽  
International Human Rights ◽  
Actual Risk ◽  
Substantial Risk ◽  
International Human ◽  
Controversial Area

AbstractHuman rights organisations have warned repeatedly that basic human rights are being challenged in the so-called 'War on Terror'. One particularly controversial area is the use of diplomatic assurances against torture. According to international human rights instruments, the state shall not return anyone to countries in which they face a substantial risk of being subjected to torture. In the 'War on Terror', an increasing number of non-citizens are being deemed 'security threats', rendering them exempt from protection in many Western states. To be able to deport such 'threats' without compromising their duties under international law, states are increasingly willing to accept a diplomatic assurance against torture – that is, a promise from the state of return that it will not subject the returnee to torture. There is wide disagreement as to whether and/or when diplomatic assurances can render sufficient protection to satisfy the obligations of non-refoulement to risk of torture. Whereas the human rights society label such assurances as 'empty promises', others view them as effective, allowing states to retain their right to remove non-citizens without violating international law. This article reviews international and selected national jurisprudence on the topic of diplomatic assurances against torture and examines if and/or when such assurances might render sufficient protection against torture to enable removals in accordance with international law. The courts and committees that have reviewed the use of diplomatic assurances against torture have identified essential problems of using them, thus rejecting reliance on simple promises not to torture. However, they have often implied that sufficient protection might be rendered by developing the assurances. I argue that this approach risks leading the governments into trying to perfect a system that is inherently flawed – whilst, incidentally, deportations to actual risk of torture continue. Even carefully modelled assurances render only unreliable protection against torture. For this, and reasons connected to undesirable side-effects of their use, I argue that the practice should be rejected.

Tideline and Turn: Possible Reasons for the Continuing Low HIV Prevalence among Glasgow's Injecting Drug Users

1994 ◽  
Vol 42 (4) ◽  
pp. 738-757 ◽  
Author(s):  
Michael Bloor ◽  
Martin Frischer ◽  
Avril Taylor ◽  
Robert Covell ◽  
David Goldberg ◽  
...  
Keyword(s):  
Drug Users ◽  
Early Report ◽  
Community Sample ◽  
Injecting Drug Users ◽  
Cross Sectional Study ◽  
Hiv Prevalence ◽  
Cross Sectional ◽  
Drug Injectors ◽  
Substantial Risk ◽  
Low Prevalence

This is an early report of data from an on-going, repeated, cross-sectional study of a community sample of Glasgow injecting drug users. Although HIV was first detected among Glasgow's drug injectors in 1985, data from the first two years of our annual samples (1990 and 1991) indicate that HIV prevalence continues to be low in this population, in the order of 1 or 2 per cent. Possible reasons for this apparent continuing low prevalence are examined. It is suggested that substantial risk reduction – reductions in injection equipment-sharing, reductions in numbers of sharing partners and restrictions in social circles of sharing partners – may have been sufficient reasons, in conjunction with limited contributions to near-stabilisation from the disproportionate attrition of the numerator population through death and cessation of injecting.

Listeria monocytogenes: silage, sandwiches and science

2005 ◽  
Vol 6 (2) ◽  
pp. 211-217 ◽  
Author(s):  
Charles J. Czuprynski
Keyword(s):  
Listeria Monocytogenes ◽  
Murine Model ◽  
Pathogenic Bacteria ◽  
Model Organism ◽  
Intracellular Pathogen ◽  
Innate And Adaptive Immunity ◽  
Potential Vector ◽  
Broad Array ◽  
Common Framework ◽  
Substantial Risk

AbstractListeria monocytogenesis amongst the most intriguing and well studied of the pathogenic bacteria. However, the understanding and perspective one has ofL. monocytogenesdepends to a large extent on the microbiological issues with which one is faced as a part of your professional duties. The focus of the veterinary clinician or investigator is likely to be foremost on the neurologic (circling disease) and reproductive diseasesL. monocytogenescauses. To the food microbiologist, the principal concern is to prevent introduction ofL. monocytogenesinto food products, or to identify its presence and prevent its multiplication to numbers of organisms that are likely to pose a substantial risk to humans who ingest the product. To the cellular immunologist, listeriosis represents a robust murine model that helped to elucidate many important concepts in innate and adaptive immunity, andL. monocytogenesis a potential vector for delivery of novel vaccines. To the student of molecular pathogenesis,L. monocytogenesis a powerful and well-characterized model organism for studying the cellular microbiology of an intracellular pathogen. In this brief overview, I will attempt to highlight some of the classical observations, and contemporary insights, onL. monocytogenesand listeriosis, and integrate these perspectives into a common framework. By so doing, I hope to provide those with one perspective on listeriosis with an appreciation of the broad array of problems and issues faced by those who focus on some other aspect ofL. monocytogenesand its pathogenesis.

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