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1 – 10 of 19Beth Ann Fiedler and Robert J. Bebber
The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory…
Abstract
Purpose
The purpose of this paper is to establish historic regulatory conditions and priority national characteristics eliciting outstanding best practices in clinical trial regulatory systems, towards global health objectives through targeted economic development.
Design/methodology/approach
Exploratory review of clinical trial processes of three industrialized nations with similar democratic processes – Japan, the UK and the USA – in order to determine the efficacy of international clinical trials.
Findings
Outstanding best practices in national vaccine clinical trials can guide the international economic development, manufacturing and distribution policy strategies necessary to form the basis of a cross‐cultural global delivery system.
Originality/value
This study's contribution to academic literature is threefold: first, it reviews established fundamental clinical trial processes for Japan, the UK and the USA; second, it distinguishes similarities and differences to determine best practices; and third, it suggests changes in regulatory vaccine clinical trials towards achieving global health objectives.
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Viewing the last dying embers of 1984, the Orwel‐lian year of Big Brother and some of its not‐so‐far off the mark predictions, the unemployment which one cannot help feeling is…
Abstract
Viewing the last dying embers of 1984, the Orwel‐lian year of Big Brother and some of its not‐so‐far off the mark predictions, the unemployment which one cannot help feeling is more apparent than real, it is hardly surprising that the subject of Poverty or the so‐called Poverty arise. The real poverty of undernourished children, soup kitchens, children suffering at Christmas, hungry children ravenously consuming free school meals has not, even now, returned.
Rocio Martin-Santos, Elfi Egmond, Myriam Cavero, Zoe Mariño, Susana Subira, Ricard Navines, Xavier Forns and Manuel Valdes
The purpose of this paper is to provide a comprehensive overview of the current knowledge regarding chronic hepatitis C (CHC) infection, antiviral therapy, depression, and gender…
Abstract
Purpose
The purpose of this paper is to provide a comprehensive overview of the current knowledge regarding chronic hepatitis C (CHC) infection, antiviral therapy, depression, and gender.
Design/methodology/approach
CHC and its treatment options were reviewed examining their relationship with depression and gender.
Findings
CHC is a high prevalent chronic infection worldwide, being similar in men and women. However, the infection shows many gender differences in terms of innate response, genetic variability (i.e. IL-28B), route of transmission (i.e. intravenous drug use), disease progression (i.e. fibrosis), lifetime period (i.e. pregnancy), and risk factors (i.e. HIV). Both the hepatitis C infection and antiviral treatment (especially when using the pro-inflammatory cytokine interferon α), are highly associated with depression, where female gender constitutes a risk factor. It seems that the new direct-acting antiviral combinations produce fewer neuropsychiatric side effects. In fact, the presence of depression at baseline is no longer a limitation for the initiation of antiviral treatment. Antidepressant drugs have been recommended as current depression and prophylactic treatment in risk subgroups. However, caution should be exercised due to the risk of drug-drug interactions with some antiviral drugs. Women should be counselled prenatal, during and after pregnancy, taking into account the clinical situation, and the available evidence of the risks and benefits of antiviral and antidepressant treatments. Multidisciplinary approach shows cost-efficacy results.
Originality/value
The paper clarifies the complex management of CHC therapy and the importance of individualizing treatment. The results also underline the need for an integrated multidisciplinary approach.
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It is estimated that food allergy affects about 7% of children and milk allergy accounts for about 1–3% of that 7%.
Anne S. De Groot, Madeline Dilorenzo, Mary Sylla and Joseph Bick
At least 20% of individuals living with HIV pass through prison and jail doors every year, in any nation, worldwide. Therefore, interventions that improve access to HIV testing…
Abstract
At least 20% of individuals living with HIV pass through prison and jail doors every year, in any nation, worldwide. Therefore, interventions that improve access to HIV testing, HIV care, and education can have a broad impact on public health in every country. The benefits of these interventions in correctional settings have already been well documented. For example, improved access to HIV testing, treatment by an HIV specialist, preventive vaccinations and prophylactic medications, screening for concomitant infections such as HCV, and pre‐release planning services have been shown to decrease HIV‐related mortality and morbidity, to reduce the risk of HIV transmission and to decrease recidivism. Education of at‐risk individuals has also been shown to reduce HIV risk behaviors. Safe distribution of condoms and needle‐exchange programs have also been demonstrated to be safe and effective, although few such programs have been implemented in the United States. While all the available evidence has demonstrated that these public health‐oriented interventions can be and are successful in correctional settings, implementation on a national and international level lags far behind the evidence. The time has come to take an evidence‐based approach to improving HIV management in correctional settings. Implementations of the HIV management interventions described in this article make good medical sense and will have a positive impact on the health of inmates and the communities to which inmates return.
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Soraiya Ebrahimpour-Koujan, Amir Ali Sohrabpour, Saeid Safari, Nima Baziar, Shima Hadavi, Laleh Payahoo and Samaneh Shabani
Coronavirus disease-2019 (COVID-19) is becoming a crucial health problem worldwide. Continued and high-speed mutations of this virus result in the appearance of new…
Abstract
Purpose
Coronavirus disease-2019 (COVID-19) is becoming a crucial health problem worldwide. Continued and high-speed mutations of this virus result in the appearance of new manifestations, making the control of this disease difficult. It has been shown that well-nourished patients have strong immune systems who mostly have short-term hospitalization compared to others. The purpose of this study is to review the major nutrients involved in the immune system reinforcement and to explain nutritional aspects during the recovery of COVID-19.
Design/methodology/approach
In this review paper, the mechanistic role of nutrients in boosting the immune system and the nutritional aspects during the recovery of COVID-19 patients were discussed. Papers indexed in scientific databases were searched using antioxidants, COVID-19, inflammation, immune system, macronutrient, micronutrient and probiotic as keywords from 2000 to 2022.
Findings
Because of the adverse effects of drugs like thrombosis, pulmonary embolism and hypercholesterolemia, a balanced diet with enough concentrations of energy and macronutrients could increase the patient's durability. The inflammatory cytokines in a vicious cycle delay patients’ rehabilitation. The main mechanistic roles of micronutrients are attributed to the downregulation of virus replication and are involved in energy homeostasis. Dysbiosis is defined as another disturbance among COVID-19 patients, and supplementation with beneficial strains of probiotics helps to exert anti-inflammatory effects in this regard. Being on a well-planned diet with anti-inflammatory properties could reverse cytokine storms as the major feature of COVID-19. Future studies are needed to determine the safe and effective dose of dietary factors to control the COVID-19 patients.
Originality/value
Being on a well-planned diet with anti-inflammatory properties could reverse cytokine storms as the major feature of COVID-19. Future studies are needed to determine the safe and effective dose of dietary factors to control the COVID-19 patients.
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Examines the tenth published year of the ITCRR. Runs the whole gamut of textile innovation, research and testing, some of which investigates hitherto untouched aspects. Subjects…
Abstract
Examines the tenth published year of the ITCRR. Runs the whole gamut of textile innovation, research and testing, some of which investigates hitherto untouched aspects. Subjects discussed include cotton fabric processing, asbestos substitutes, textile adjuncts to cardiovascular surgery, wet textile processes, hand evaluation, nanotechnology, thermoplastic composites, robotic ironing, protective clothing (agricultural and industrial), ecological aspects of fibre properties – to name but a few! There would appear to be no limit to the future potential for textile applications.
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Lawrence F. Wolper, David N. Gans and Thomas P. Peterson
As a key component of the American health care system, the physician office could be the front line in a bioterrorist attack. Nationally and locally, the primary focus on this…
Abstract
As a key component of the American health care system, the physician office could be the front line in a bioterrorist attack. Nationally and locally, the primary focus on this subject appears to be from a hospital preparedness and public health agency perspective, with little attention devoted to primary physician providers in their own offices, and those specialists to whom patients may be referred. While unrelated to bioterrorism, the recent SARS outbreak also brings to the forefront the need for physicians offices to be able to clinically, operationally, and managerially respond to illnesses that mirror the symptoms of known illnesses, but may be more virulent new organisms or hybrids of existing organisms. If the face of bioterrorism is subtle and slow in its presentation, physicians, in their own offices, could be the first providers of care. Will they be prepared, or will they be among the first fatalities in a bioterrorist attack?
Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA…
Abstract
Purpose
Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA responsible for overseeing and regulating the manufacturing, marketing, and distribution of vaccines. The paper aims to discuss this issue.
Design/methodology/approach
Expert review.
Findings
Developed countries have established governmental regulatory agencies to review and determine the safety and effectiveness of vaccines to ensure that the manufacture, sale, and use of vaccines are adequately regulated. However, even today, many developing countries do not have established NRAs. Furthermore, despite similarities, there are still substantial differences in how regulatory authorities in different countries perform minimum functions required for effective regulation of pharmaceutical products, including vaccines. The World Health Organization (WHO), although not a governmental NRA, uses a consultative approach involving its Expert Committee on Biological Standardization and Biologicals Unit to develop regulatory criteria and identify and consolidate current consensus opinions on key regulatory issues. It is through this approach that WHO informs NRAs on the necessary scientific background required to assess and advise on optimal regulatory approaches and methodologies. This paper will focus on the evolution of the US FDA and its role in regulation of vaccines to illustrate the function of a vaccine NRA.
Originality/value
Vaccines are an important resource for protecting people and communities from the mortality and morbidity associated with many infectious diseases. The assessment, licensure, control and surveillance of vaccines are the responsibilities of government regulatory authorities.
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In years past, when life seemed simpler and the Law much less complicated, jurists were fond of quoting the age‐old saying: “All men are equal before the Law.” It was never…
Abstract
In years past, when life seemed simpler and the Law much less complicated, jurists were fond of quoting the age‐old saying: “All men are equal before the Law.” It was never completely true; there were important exemptions when strict legal enforcement would have been against the public interests. A classic example was Crown immunity, evolved from the historical principle that “The King can do no wrong”. With the growth of government, the multiplicity of government agencies and the enormous amount of secondary legislation, the statutes being merely enabling Acts, this immunity revealed itself as being used largely against public interests. Statutory instruments were being drafted within Ministerial departments largely by as many as 300 officers of those departments authorized to sign such measures, affecting the rights of the people without any real Parliamentary control. Those who suffered and lost in their enforcement had no remedy; Crown immunity protected all those acting as servants of the Crown and the principle came to be an officials' charter with no connection whatever with the Crown. Parliament, custodian of the national conscience, removed much of this socially unacceptable privilege in the Crown Proceedings Act, 1947, which enabled injured parties within limit to sue central departments and their officers. The more recent system of Commissioners—Parliamentary, Local Authority, Health Service—with power to enquire into allegations of injustice, maladministration, malpractice to individuals extra‐legally, has extended the rights of the suffering citizen.