The National Ethics Committee: a truly valuable asset for clinical trials?

Advances in biomedicine, increased patient autonomy, and higher average life expectancy, have contributed to raising a multitude of questions relating to Clinical Ethics. Though these aspects stand on their own, national or community-level legislation that is unable to meet Ethical demands, or satisfies them only partially, it will never be able to satisfy aims and interests of a rapidly changing society. The Ethical protection of the individual in the context of life and health has been entrusted to independent, impartial bodies: Territorial Ethics Committees. In 2015, Minacori et al1 posed the following question: Research Ethics Committees and clinical research in Italy: where are we going? After analyzing the Italian legislation regulating Ethics Committees and their practices, the authors noted that though the November 2012 Law had harmonized Territorial Ethical Committee activities at a national level, it neglected to address certain critical points such as the differing deadlines by which the Committees were required to present their opinions, and the drastic reduction of the Committees themselves which had, in fact, hampered their activity. What’s more, problems arose from the need for Committee members to receive specific training2 and delays in presenting opinions in research institutes extraneous to those in which the Ethical issue had originally arisen

Metabolic syndrome, hypertension, and nervous system injury: Epidemiological correlates

Metabolic syndrome (MetS) is a common and complex disorder combining hypertension, obesity, dyslipidemia, and insulin resistance. MetS represents a risk factor for changes in cognitive functions in older age, and several studies have suggested that MetS may be linked to dementia. This article reviews the main evidences about the relationship between MetS and neurodegenerative disease. Starting from an epidemiological point of view, the article analyzes medico-social aspects related to MetS, considering the reduction of work capacity and the condition of disability that it involves. Some authors affirm that on the basis of current Italian legislation, it is possible to consider the syndrome as a disability. This is because all the diseases that make up MetS are high-risk clinical pathological conditions. For these reasons, a joint action is required to contain the incidence of MetS, the high social costs, and the loss of productivity related to the syndrome. In conclusion, healthcare initiatives could be adopted in order to increase the understanding of the pathogenic contributions of each element on MetS and how they can be modified. These actions will be useful to reduce healthcare costs and can lead to more effective prevention of metabolic disease, thus promoting good health. Abbreviations: MetS: Metabolic syndrome; WHO: World Health Organization; CVD: cerebrovascular diseases; AD: Alzheimer's Disease; VaD: Vascular Dementia; IDF: International Diabetes Federation; T2DM: type 2 diabetes mellitus; CAD: coronary artery disease; MCI: mild cognitive impairment; NCDs: Non Communicable Diseases; BMI: Body Mass Index; ICIDH: International classification of impairments, disabilities and handicaps

Ethical challenges to medical assistance at sea

A B S T R A C T Illnesses and accidents occur on board seagoing vessels. In these cases, lacking medical or paramedical personnel, the ship's captain or an officer delegated by him provides medical care and in general asks for medical advice by means of telecommunication systems. The situation is in general different on passenger ships, on board of which are doctors or paramedical personnel. Telemedicine services for ships without medical facilities are provided by the Telemedical Assistance Services (TMAS). The captain is always responsible for medical care and final decisions regarding health of seafarers. Full responsibility for the diagnosis and prescription of treatments belongs to the doctor on board or to the TMAS physician. The physician on the ship or at TMAS should protect the privacy of patients. The telemedicine services and in particular the doctor-patient relationship on vessels present ethical and legal issues that are not the same as those experienced ashore. These issues are discussed and some possible solutions to improve patient-physician relationships are suggested

Effects of pidotimod and bifidobacteria mixture on clinical symptoms and urinary metabolomic profile of children with recurrent respiratory infections: a randomized placebo-controlled trial

Many preschool children develop recurrent respiratory tract infections (RRI). Strategies to prevent RRI include the use of immunomodulators as pidotimod or probiotics, but there is limited evidence of their efficacy on clinical features or on urine metabolic profile