NIAID ClinRegs-a Public Database of Country Clinical Research Regulatory and Ethics Requirements: Design and Utilization Analysis.

Regulatory compliance is challenging for multinational clinical trials. Conflicts between country requirements impedes research and slows the approval of medicines, leading the pharmaceutical industry to devote significant resources to this area. Many academic centers and nonprofits cannot support industry-level investment and are vulnerable to noncompliance.

Immunity, Life and Dancing Starlings: A Physician's Perspective.

Immune function is the most basic physiological process in humans and indeed throughout the animal kingdom. Interestingly, the vast majority of textbooks of physiology do not include a chapter on immunity. Our species survival is dependent on the diversity of the immune response and the ability for antigen presentation and effector mechanisms to be enormously promiscuous.

Mars can wait: facing the challenges of our civilization.

We are overwhelmed by warnings about inevitable geophysical and human problems. Earth is beset by escalating, manmade, environmental crises and our exploding population will eventually lack water, food and vital materials. This suggests, together with increasing poverty, deepening social unrest and advanced techniques for mass killing, that civilization will break down long before atmospheric CO2 or resistant microbes become catastrophic.

Fullerene and the origin of life.

The role of carbon in the development of life and as the structural backbone of all organisms is universally accepted and an essential part of evolution. However, the molecular basis is largely unknown and the interactions of carbon with nitrogen and oxygen in space are enigmatic. In 1985, the previously unknown form of carbon, coined fullerene, was discovered.

Physics, biology and the origin of life: the physicians' view.

Physicians have a great interest in discussions of life and its origin, including life's persistence through successive cycles of self-replication under extreme climatic and man-made trials and tribulations. We review here the fundamental processes that, contrary to human intuition, life may be seen heuristically as an ab initio, fundamental process at the interface between the complementary forces of gravitation and quantum mechanics. Analogies can predict applications of quantum mechanics to human physiology in addition to that already being applied, in particular to aspects of brain activity and pathology.

Pregnancy and lactation after breast cancer elevate plasma prolactin, do not shorten and may prolong survival.

The affliction of breast cancer is doubled for young patients wishing to have a child. Because estrogens can cause breast cancer and its elevation during pregnancy, clinical advice historically restricted pregnancy to at least 5 years post-diagnosis. Opposing evidence gradually relaxed this.

Melanin directly converts light for vertebrate metabolic use: heuristic thoughts on birds, Icarus and dark human skin.

Pigments serve many visually obvious animal functions (e.g. hair, skin, eyes, feathers, scales).

Prolactin does not cause breast cancer and may prevent it or be therapeutic in some conditions.

The polypeptide hormone prolactin (PRL), ubiquitous and multifunctional in vertebrates, always interested biologists, was of restricted concern to clinicians and researched little compared to insulin and growth hormone. PRL in lactation initially aroused relatively little interest, but it rose when with ovarian steroids and chemical carcinogens, it was implicated in rodent mammary carcinoma. It declined when PRL suppression did not counter breast cancer.

The origin of life and the left-handed amino-acid excess: the furthest heavens and the deepest seas?

The origin of life is an extraordinary problem that leads back to the structure and dynamics of the cosmos and early development of organic molecules. Within that wider question lies an unsolved problem that has troubled biologists for 150 years. What is the origin of the dominant presence of left-handed stereoisomers of amino acids in nature even though their synthesis normally results in an equal mixture of the right- and left-handed molecular forms? We propose that asymmetric Earth rotation caused at dawn and dusk circularly polarized UV light (CPUVL) of opposite polarity and reversed temperature profiles in the oceans.