Ethics of the “body count” in clinical trials

The Lancet ◽  
1998 ◽  
Vol 352 (9126) ◽  
pp. 495-496
Author(s):  
Howard Spiro
Keyword(s):  
Clinical Trials ◽  
The Body ◽  
Body Count

ACE-2-Receptors of the Epidermis, Dermal Vascular Walls and Sebaceous Gland Cells: The Way of COVID-19 Entry into the Body?

2020 ◽  
Author(s):  
Stefan Bittmann
Keyword(s):  
Clinical Trials ◽  
Viral Infection ◽  
Sebaceous Gland ◽  
The Body ◽  
Viral Agent ◽  
Therapy Options ◽  
Vascular Walls ◽  
Fish Market ◽  
The World ◽  
The Usa

Since the outbreak near a fish market in Wuhan, China, in December 2019, researchers have been searching for an effective therapy to control the spreading of the new coronavirus SARS-CoV-2 and inhibit COVID-19 infection. Many countries like Italy, Spain, and the USA were ambushed by this viral agent. To date, more than 2.5 million people were infected with SARS-CoV-2. There is no clear answer, why SARS-CoV-2 infects so many people so fast. To date of April 2020, no effective drug has been found to treat this new severe viral infection. There are many therapy options under review and clinical trials were initiated to get clearer information, what kind of drug can help in this devastating and serious situation. The world has no time.

scholarly journals The perils of the body count

2016 ◽  
Vol 151 (4) ◽  
pp. 1110-1111
Author(s):  
Tom Treasure ◽  
Samer Nashef
Keyword(s):  
The Body ◽  
Body Count

Non-Ceruloplasmin Copper as a Stratification Biomarker of Alzheimer’s Disease Patients: How to Measure and Use It

2021 ◽  
Vol 18 ◽  
Author(s):  
Rosanna Squitti ◽  
Mariacarla Ventriglia ◽  
Alberto Granzotto ◽  
Stefano L. Sensi ◽  
Mauro Ciro Antonio Rongioletti
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Clinical Trials ◽  
Cognitive Impairment ◽  
Cost Effective ◽  
The Elderly ◽  
The Body ◽  
Eligibility Criterion ◽  
Growing Body ◽  
Proper Balance

: Alzheimer’s disease (AD) is a type of dementia very common in the elderly. A growing body of recent evidence has linked AD pathogenesis to copper (Cu) dysmetabolism in the body. In fact, a subset of patients affected either by AD or by its prodromal form known as Mild Cognitive Impairment (MCI) have been observed to be unable to maintain a proper balance of Cu metabolism and distribution and are characterized by the presence in their serum of increased levels of Cu not bound to ceruloplasmin (non-ceruloplasmin Cu). Since serum non-ceruloplasmin Cu is a biomark- er of Wilson's disease (WD), a well-known condition of Cu-driven toxicosis, in this review, we pro- pose that in close analogy with WD, the assessment of non-ceruloplasmin Cu levels can be exploit- ed as a cost-effective stratification and susceptibility/risk biomarker for the identification of some AD/MCI individuals. The approach can also be used as an eligibility criterion for clinical trials aim- ing at investigating Cu-related interventions against AD/MCI.

scholarly journals Peptide hormone relaxin: from bench to bedside

2018 ◽  
Vol 314 (6) ◽  
pp. R753-R760 ◽  
Author(s):  
Maria Jelinic ◽  
Sarah A. Marshall ◽  
Dennis Stewart ◽  
Elaine Unemori ◽  
Laura J. Parry ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Animal Models ◽  
Animal Studies ◽  
Ischemia Reperfusion ◽  
Peptide Hormone ◽  
The Body ◽  
Cervical Ripening ◽  
Matrix Remodeling ◽  
Vitro Fertilization

The peptide hormone relaxin has numerous roles both within and independent of pregnancy and is often thought of as a “pleiotropic hormone.” Relaxin targets several tissues throughout the body, and has many functions associated with extracellular matrix remodeling and the vasculature. This review considers the potential therapeutic applications of relaxin in cervical ripening, in vitro fertilization, preeclampsia, acute heart failure, ischemia-reperfusion, and cirrhosis. We first outline the animal models used in preclinical studies to progress relaxin into clinical trials and then discuss the findings from these studies. In many cases, the positive outcomes from preclinical animal studies were not replicated in human clinical trials. Therefore, the focus of this review is to evaluate the various animal models used to develop relaxin as a potential therapeutic and consider the limitations that must be addressed in future studies. These include the use of human relaxin in animals, duration of relaxin treatment, and the appropriateness of the clinical conditions being considered for relaxin therapy.

Nanoceuticals as an Emerging Field: Current Status and Future Prospective

2021 ◽  
Vol 17 ◽  
Author(s):  
Reetu Malik ◽  
Jyoti Rathi ◽  
Deeksha Manchanda ◽  
Manish Makhija ◽  
Deepshikha Kushwaha ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Biological Activities ◽  
Food Products ◽  
The Body ◽  
Current Status ◽  
Target Cells ◽  
Food Ingredients ◽  
Novel Foods ◽  
Quality Of Food

Background: The safety and quality of food has been a matter of great discussion throughout the centuries and the application of nanotechnology in the field of nutraceuticals i.e. nanoceuticals has improved the variety and protection of food products in many ways. Objective: Improving the quality and safety of the food products with a view to improve public health and the invasion of nanotechnological advancements in the area of nutrition has resulted in the expansion of novel foods with improved oral bioavailability as well as thermal stability. The main objective of this review is to summarize available literature on nanoceuticals including patents and clinical trials. Method: The review was extracted from the searches performed at PubMed, Google Patents and Google Scholars, etc. Data from these searches was collected and evaluated for getting the information about the available literature on the nanoceuticals. Along with this, some reported patents have also been included in this review in order to conclude the future of nanoceuticals. Result: The literature so obtained was studied thoroughly as per the requirement of the objective of this review. The details of nanoceuticals including major applications, regulatory aspects, some reported patents and clinical trials are compiled here in this review. Nanoceuticals like vitamins, antibiotics, bioactive peptides, probiotics etc., which are dispersed, absorbed or incorporated in nano diameter range sacs, having improved solubility, delivery properties, biological activities, protection against degradation and therefore having improved biological activities and delivery to the target cells and tissues in the body. Different regulations from various countries recommended that any food ingredients which results from the use of nanotechnologies must undergo safety risk assessment standards before entering into the market as nano-food. Conclusion: The idea of “nanoceuticals” is increasing enthusiasm and marketable dairy/food and food supplements. This article focuses on the history, applications, regulation aspects, patents, clinical trials and future prospects of nanoceuticals.

scholarly journals Passiflora incarnata in Neuropsychiatric Disorders—A Systematic Review

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3894
Author(s):  
Katarzyna Janda ◽  
Karolina Wojtkowska ◽  
Karolina Jakubczyk ◽  
Justyna Antoniewicz ◽  
Karolina Skonieczna-Żydecka
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Memory Loss ◽  
Neuropsychiatric Disorders ◽  
The Body ◽  
Scientific Databases ◽  
Perennial Plant ◽  
Passiflora Incarnata ◽  
Study Participants

Background: Stress is a natural response of the body, induced by factors of a physical (hunger, thirst, and infection) and/or psychological (perceived threat, anxiety, or concern) nature. Chronic, long-term stress may cause problems with sleep, concentration, and memory, as well as affective disorders. The passionflower (Passiflora incarnata) is a perennial plant with documented therapeutic properties. The literature data suggest that the passionflower itself, as well as its preparations, helps reduce stress and can therefore be helpful in the treatment of insomnia, anxiety, and depression. The objective of this systematic review was to evaluate Passiflora incarnata in terms of its neuropsychiatric effects. Methods: The scientific databases PubMed, ClinTrials.gov, and Embase were searched up to 22 October 2019. The search identified randomized clinical trials describing the effects of Passiflora incarnata in neuropsychiatric disorders. Results: The systematic review included nine clinical trials. The duration of the studies included in the analysis varied widely, from one day up to 30 days. Study participants were no less than 18 years old. In each of the papers, the effects of passionflower were measured by using a number of different tests and scales. The majority of studies reported reduced anxiety levels following the administration of Passiflora incarnata preparations, with the effect less evident in people with mild anxiety symptoms. No adverse effects, including memory loss or collapse of psychometric functions, were observed. Conclusion: Passiflora incarnata may be helpful in treating some symptoms in neuropsychiatric patients.

Beyond the Body Count

2019 ◽  
Vol 12 (3) ◽  
pp. 33-46
Author(s):  
Patricia Krueger-Henney
Keyword(s):  
Human Life ◽  
Black Girls ◽  
Classification Systems ◽  
The Body ◽  
Empirical Science ◽  
Girls Of Color ◽  
The Social ◽  
Critical Social Science ◽  
Field Notes ◽  
Body Count

I position critical ethnographic researcher field notes as an opportunity to document the physical and ideological violence that white settler states and institutions on the school-prison nexus inflict on the lives of girls of color generally and Black girls specifically. By drawing on my own field notes, I argue that critical social science researchers have an ethical duty to move their inquiries beyond conventions of settler colonial empirical science when they are wanting to create knowledges that transcend traditions of body counts and classification systems of human lives. As first responders to the social emergencies in girls’ lives, researchers can make palpable spatialization of institutionalized forms of settler epistemologies to convey more girl-centered ways of speaking against quantifiable hierarchies of human life.

War, violence, and population: making the body count

2010 ◽  
Vol 41 (3) ◽  
pp. 429-430
Author(s):  
R.J. Fisher
Keyword(s):  
The Body ◽  
Body Count

scholarly journals Ethics of placebo use in randomised studies: primer for physiotherapists

2006 ◽  
Vol 62 (4) ◽  
Author(s):  
N. T. Amusat
Keyword(s):  
Clinical Trials ◽  
Health Professionals ◽  
Randomized Trials ◽  
The Body ◽  
Basic Knowledge ◽  
Evidence Based ◽  
Active Comparator ◽  
Ethical Concerns ◽  
Effectiveness Studies

Evidence based practice is driving the need to establish effectiveness of interventions employed by health professionals. The need to show effectiveness for interventions employed by physiotherapists has not been greater. This has led to an increase in the body of evidence available on physiotherapeutic methods. The quality of the evidence, however, has made it difficult to draw definitive conclusions on the effect of some of these interventions. There is therefore a call for improved methodologies in physiotherapy effectiveness studies. These needs may prompt even greater use of randomized trials with or without a placebo arm, which are regarded as the best way to show effectiveness. The use of placebo rather than an active  comparator has advantages in showing absolute effectiveness of interventions. However, there may be ethical concerns posed by its use in clinical trials. The balance is therefore required between good ethics and sound science. The goal of this article is to provide physiotherapists with a basic knowledge of the ethics of placebo use in randomized studies. This should prepare researchers to better balance ethical needs with scientific imperatives when designing effectiveness studies.

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