Showing 17 ideas for tag "ClinicalBiomarkers"

The Human Placenta Project

Potential involvement of trophoblast inclusions in the etiology of Autism Spectrum Disorders

One such topic concerns the etiology of autism and autism spectrum disorders, for which the placenta may be involved. Recent research has identified an increased incidence of trophoblast inclusions in the placenta of children that have developed ASD. This lesion also may be associated with, or indicative of altered zinc nutriture, as zinc deficiencies also have been observed in children that develop ASD

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The Human Placenta Project

Need for a strategic approach to clinical biomarker discovery

The drug development world has evolved a set of generally agreed upon steps for advancing potential targets forward. This is in part because the end goal - FDA approval and commercial viability drive the requirements and processes. The identification of clinically useful biomarkers is often an outcome of basic research into a biologic process that tangentially is recognized to have clinical utility. Validation processes... more »

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The Human Placenta Project

Cervical trophoblast: A proxy of placental health and function in early pregnancy

There is a clear gap in our ability to investigate the placenta and pregnancy risk in the first trimester of pregnancy on a cellular level.

It is well established that protein expression is different in placental cells of pregnancies that developed placental disorders including severe preeclampsia (PE). This idea exploits the fact that the placenta naturally sheds hundreds of trophoblast cells into the cervical canal... more »

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The Human Placenta Project

MRI - Premeeting Discussion Summary

MRI Safety in First Trimester

Is there a need for a consensus statement from experts representing major societies such as ISMRM, RSNA, SPR, Obstetrics and Gynecology (e.g. Society of Maternal-Fetal Medicine, ISUOG), about the safety of fetal MRI, particularly in the first trimester for research purposes as no specific FDA guidelines exist?

Some sites using as early as 12 weeks.

Do we need more nonhuman primate studies?... more »

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The Human Placenta Project

Sexual dimorphism in placental physiology and pathophysiology

The placenta is a unique organ, made up of cells with 2 similar yet distinct genetic makeup, maternal and fetal. Further, a placenta can be either a female or a male placenta, corresponding to the sex of the fetus. Understanding the role of sexual dimorphism of the placenta in terms of its development, maturation, function and basic physiology is needed but sorely lacking. Such insights will provide the grounding for... more »

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The Human Placenta Project

Correlation between Development of Placenta and the Fetal brain

The hypothesis is that a symbiotic relationship exists between the placenta and the fetal brain. A healthy placenta leads to healthy brain development in the fetus. Studies are warranted to find the correlation between the placenta and the fetal brain and the various clinical biomarkers and circulating factors aiding this process and the hypoxia-ischemia pathway

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The Human Placenta Project

Innovation in Regulatory Science

Re. Aims G3 and G5

Contact: Anup Challa, Vanderbilt (anup.p.challa.1@vumc.org)

Assessment of the drug safety in pregnancy information necessary for new drug applications (NDAs) remains severely underpowered due to a lack of inclusion of pregnant patients in randomized, controlled drug trials (RCTs) for ethical reasons and the subsequent dearth of knowledge on the effects of many agents on the human maternal-fetal interface.... more »

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The Human Placenta Project

Single cell and placental research

I am the Principal Investigator of new birth cohort study that is currently being planned and will be implemented in Nigeria. We plan to collect biological samples including placental tissue. We will appreciate insight from investigators in the field about how single cell research will advance scientific investigation of the placenta within the context of developmental origin of health and diseases. This will enable know... more »

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The Human Placenta Project

Supporting People with Disabilities

The National Center for Medical Rehabilitation Research (located within the NICHD) would like to highlight three issues that may arise in the context of the Human Placenta Project:

β€’ Ensure that people with disabilities (PWD) are included among the subject populations – and special efforts are made to support their reproductive health and opportunities. Often, PWD are not asked about reproductive health and are not offered... more »

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The Human Placenta Project

Hearing all voices - Premeeting Discussion Summary - Tracy Bale and Ann Celi

Community Engagement Challenges and Opportunities

β€’ BEGIN in this space, VALUE diverse populations and put them at the center of your efforts

o remember racial/ethnic cultural diversity is not always present in biobanks

β€’ This takes real TIME, needs to be a concerted and consistent effort in relationship building, trust-building.

β€’ Will need to build TRUST- this may include community leaders such as local church/faith... more »

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The Human Placenta Project

Another way to predict GDM?

Visceral Adipose Tissue Depth Measured During First Trimester Of Pregnancy May Predict Gestational Diabetes Better Than Current Clinical Indicators, Study Indicates

Medwire News (4/20, McDermid) reports, "Visceral adipose tissue depth...measured during the first trimester of pregnancy predicts gestational diabetes better than current clinical indicators," investigators concluded. What's more, "the technique had a positive... more »

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The Human Placenta Project

Big Data, AI/ML: Treasure Chest of Pandora's box?

Women's health and obstetrics in general, and the placenta, in particular, have not received the same level of research focus as many specific disease areas in spite of impacting much greater numbers of people because of appropriate limitation in experimental approaches. The measurement and aggregation of significant data over the course of a pregnancy (and post-partum) involving clinical and physiological biomarkers... more »

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The Human Placenta Project

Integrated study of placenta and pregnancy, towards personalized medicine

Unlike any other pathologies, adverse pregnancy can be captured from its inception to its conclusion as these are well-defined start and endpoints. Additionally, pregnancy occurs in a defined time frame lasting less than a year (<42 weeks). Nearly all other pathologies develop over years or decades. Relative to other extensive population studies like the Framingham heart study following pregnancy from conception to delivery... more »

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The Human Placenta Project

Can VEGF be used as an early marker of preeclampsia?

The proper identification and clinical management of preeclampsia have been my passion since becoming an ob-gyn physician in 1987. The disproportionate deaths of pregnant women and new moms who look like me are unsettling. Early angiogenic markers that help identify increased risk factors for the diagnosis of preeclampsia would be monumental. I hope you will consider it as an area of future research, taking into consideration.... more »

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The Human Placenta Project

Is VEGF the cause of multi-organ dysfunction during preeclampsia ?

The proper identification and clinical management of preeclampsia have been my passion since becoming an ob-gyn physician in 1987. The disproportionate deaths of pregnant women and new moms, especially women of color are unsettling. Early angiogenic markers that help identify increased risk factors for the diagnosis of preeclampsia would be monumental.

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