Research conducted on gestating women globally during trials

The aim of clinical research is to impart knowledge that will improve human health or improve understanding of human physiology. Although, till the end of 20 century pregnancy was always under exclusion criteria, now pervasive exclusion of pregnant women in clinical trials is currently not justified. Pregnancy brings in an array of anatomical, physiological and biochemical changes that can impact the pharmacokinetics of important medications. Pregnancy is often accompanied by chronic diseases like diabetes, hypertension, tuberculosis, HIV, depression which can require long term therapy. This indicates a need for studies being conducted exclusively in pregnant women. Current communication narrates ethical and regulatory aspects of inclusion of pregnant women in clinical trials.

Depicting the Vhavenda Women Initiation Schools and Their Cultural Practices in Limpopo Province

Growing up for many African people has been marked by rites of passage. Vhavenda girls attend various initiation schools that served as rites of passage from one stage to another. The purpose of this study was to explore the initiation schools attended by Vhavenda girls for knowledge preservation. The study is qualitative where data was collected from 15 traditional knowledge holders purposefully using interviews as a tool to collect data. The study revealed that girls attended different schools at various stages from Musevhetho, followed by Vhusha then Domba, which is divided into Tshikanda, Ludodo, and Tshilalandoima. All these schools served a critical purpose on the development of a girl child through to adulthood stage. Knowledge shared in the school covered mostly life skills and human physiology. With the introduction of formal schools, the former was discarded and labeled barbaric leaving a void and opening a door to many social challenges faced by girl children within the Vhavenda community members.

Physiological Hazards and Advancement of COVID-19 in Patients as a Result of Habitual and Prolong Face Mask Usage: Potential Prevention

Background: Since the first report of coronavirus disease widely known as COVID-19, in late December 2019; face masks (medical, surgical etc.) became one of the preventive/common measures adopted, which in turn resulted to its habitual use. The habitual use of the masks portrayed potential physiological hazards as it is suggested to affect the human physiology adversely. Content: This article highlighted consequences of habitual and prolonged face mask usage which includes; potential physiological hazards and advancement of COVID-19 in infected individuals that employ its use. Conclusion: The article did not undermine the usefulness of surgical or medical mask as personal protective equipment worn to prevent transmission of airborne infections (COVID-19, etc.), but the article suggests avoidance of habitual and prolonged use of masks and possible ways to use it in order to prevent physiological hazards that result from its habitual use. Keywords: COVID-19, face mask, physiological hazard, habitual use, frequent.

Ethics in Clinical Studies: The Dilemma of very Young and Old

The objectives of the research are to percolate knowledge which can improve health and improve understanding of human physiology. Pervasive exclusion of children and elderly in clinical trials as is happening today is not justified. Children have different physiology and pharmacology from adults; often adverse effects are also different and specific. Diseases like neonatal hyperbilirubinemia, infantile spasms are very age specific. Elderly too, have age specific issues like dementias, malignancies, weakened systems and polypharmacy that make them a special cohort. Clinical trials in these age groups are essential so as to gather comprehensive data about a medication across all age groups. Informed consent is a challenge in both these groups. It can be remedied by obtaining consent from parents, or legally acceptable representative in case of children and care givers and/or LARs in case of the elderly. Oral assent from 7 to 11 years, and written assent from 12 to 18 years and in the elderly, along with consent from the LAR, parents, care givers as the case may be, forms the bedrock of good clinical trial ethics.

The Lens of “Thingness”

Environmental medicine and related fields have developed from a structural perspective that assigns a static, anatomical “thingness” to our physiology and our environment. This viewpoint arises from a reductionist school of thought and foundational biomedical discoveries such as the discovery that human organs are made up of cells organized as tissues or that our DNA is the source “code” for the building blocks of life. As a consequence of these discoveries and their perceived importance, medical sciences have organized the study of the human body into the study of component parts. Attempts to incorporate time into existing structural perspectives have often taken the form of multiple structural analyses laced together as a circuit operating in a series of connections. Such approaches ignore that humans and their environment are temporally dynamic processes. Environmental Biodynamics argues for a functional perspective that rejects the reductionist view of human physiology and the human environment. In stark contrast to the prevalent structural paradigms, this approach places temporal dynamics at its core.

Environmental Biodynamics

The book provides a new conceptual framework to explain the interaction of complex systems, specifically humans and their environment. It proposes that human physiology and the environment do not “connect” with each other in a direct, unidirectional manner, like a beaker pouring water into a cup. Rather, the authors propose the Biodynamic Interface Conjecture with the central axiom that complex systems cannot interact directly or exist in isolation due to temporally embedded functional interdependencies within and between systems. The authors propose that human physiology and the environment contribute to the formation of an interface, and by doing so they give rise to an intermediary that guides the interaction by letting some influences pass between the systems while restricting others. This proposition counters many structural approaches that assume that complex systems, such as the environment and humans, can transfer information directly between them while remaining discrete entities. Although developed for environmental health sciences, the conjecture has broader implications for the study of complex system interactions across various levels of organization, and the central role of time and temporal dynamics in system-to-system information exchange. This conjecture also argues against causal paradigms that (incorrectly) assume that systems are distinct entities interacting directly and ignore boundary conditions, and organizational levels, and complexity inherent in biological and environmental systems.

Introduction to Environmental Biodynamics

Chapter 1 outlines the axioms of the biodynamic interface conjecture, each of which are detailed in subsequent chapters. It is shown that in order to properly identify and characterize any dynamic system, it is necessary to identify more than a few isolated “things” making up the pattern. Rather, one must know the sequence of events and the organization of the system in order to understand and recognize its function in both space and time. In essence, Environmental Biodynamics seeks to understand how the environment and human physiology interact through a focus on functional interfaces; specifically the focus is on the patterns that emerge in the integration of the environment into human physiology rather than on isolated “snapshots” taken in passing.