PUER ("Previously Unrecognized Emerging Risks") Life Clinical Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Measurements Only.
- Кому может быть актуально
- Состояния в реестре: Aging. Базовые параметры: 18 лет — 90 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Prospective, Non-Randomized, Multi-Center Observational Study to Establish a Physical Baseline Profile for Individual Study Subjects Using Various Modalities and Identify Deviations Via Longitudinal Monitoring That May Develop Over Time
Обзор
This is a minimal risk, prospective, non-randomized, multi-center population based observational study to establish a physical baseline profile for individual study subjects using various modalities (blood draws, non-invasive imaging, stool samples, saliva samples) and identify deviations through longitudinal monitoring that may develop over time and may be relevant to human health and healthy longevity.
Подробное описание
The two key elements of the PUER Research protocol include (1) molecular and laboratory profiling and (2) non-invasive imaging and wearables/ "quantified self" measurements. All elements are optional. Molecular assessments will be conducted using peripheral blood samples, and potentially urine, stool or saliva samples. Non-invasive imaging assessment will consist of magnetic resonance imaging (MRI) and computerized tomography (CT) scans, ultrasound, and x-ray. All imaging modalities are optional. Other functional assessments, including respiratory, cardiac and other functions, as well as self-quantifiable assessments via wearables, may also be conducted and are optional.
The study will result in longitudinal data collection to inform if any modalities employed here can inform of baseline deviations for individuals. Researchers at study sites will not be blinded to the data being collected during this study.
Вмешательства
- Диагностический тест Measurements Only
This is an observational study only using biospecimen and imaging-based measurements only
Первичные конечные точки
- Biomarkers that exhibit significant change [Срок оценки: 12 Months]
Критерии участия
Критерии включения
- Male or non-pregnant female; age 18 to 90
- Absence or presence of any medical history or any signs or symptoms of any disease
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at all visits
Критерии исключения
- Unwillingness or inability to participate in the study
- Unwillingness or inability to provide written Informed Consent Form
- WOCBP with positive pregnancy test at enrollment or at any visit
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- Puer Research, LLC — Atlanta
Публикации
- Amendola LM, Dorschner MO, Robertson PD, Salama JS, Hart R, Shirts BH, Murray ML, Tokita MJ, Gallego CJ, Kim DS, Bennett JT, Crosslin DR, Ranchalis J, Jones KL, Rosenthal EA, Jarvik ER, Itsara A, Turner EH, Herman DS, Schleit J, Burt A, Jamal SM, Abrudan JL, Johnson AD, Conlin LK, Dulik MC, Santani A, Metterville DR, Kelly M, Foreman AK, Lee K, Taylor KD, Guo X, Crooks K, Kiedrowski LA, Raffel LJ, PMID 25637381
- Arnoldi E, Gebregziabher M, Schoepf UJ, Goldenberg R, Ramos-Duran L, Zwerner PL, Nikolaou K, Reiser MF, Costello P, Thilo C. Automated computer-aided stenosis detection at coronary CT angiography: initial experience. Eur Radiol. 2010 May;20(5):1160-7. doi: 10.1007/s00330-009-1644-7. Epub 2009 Nov 5. PMID 19890640
- Assarsson E, Lundberg M, Holmquist G, Bjorkesten J, Thorsen SB, Ekman D, Eriksson A, Rennel Dickens E, Ohlsson S, Edfeldt G, Andersson AC, Lindstedt P, Stenvang J, Gullberg M, Fredriksson S. Homogenous 96-plex PEA immunoassay exhibiting high sensitivity, specificity, and excellent scalability. PLoS One. 2014 Apr 22;9(4):e95192. doi: 10.1371/journal.pone.0095192. eCollection 2014. PMID 24755770
- Bennuru S, Lustigman S, Abraham D, Nutman TB. Metabolite profiling of infection-associated metabolic markers of onchocerciasis. Mol Biochem Parasitol. 2017 Jul;215:58-69. doi: 10.1016/j.molbiopara.2017.01.008. Epub 2017 Feb 8. PMID 28188804
- Bromberg Y. Building a genome analysis pipeline to predict disease risk and prevent disease. J Mol Biol. 2013 Nov 1;425(21):3993-4005. doi: 10.1016/j.jmb.2013.07.038. Epub 2013 Aug 5. PMID 23928561
- Chong CA, Tomlinson G, Chodirker L, Figdor N, Uster M, Naglie G, Krahn MD. An unadjusted NNT was a moderately good predictor of health benefit. J Clin Epidemiol. 2006 Mar;59(3):224-33. doi: 10.1016/j.jclinepi.2005.08.005. PMID 16488352
- Crick F. Central dogma of molecular biology. Nature. 1970 Aug 8;227(5258):561-3. doi: 10.1038/227561a0. No abstract available. PMID 4913914
- David CEB, Lucas AMB, Cunha PLO, Viana YIP, Yoshinaga MY, Miyamoto S, Filho ABC, Varela ALN, Kowaltowski AJ, Facundo HT. Calorie restriction changes lipidomic profiles and maintains mitochondrial function and redox balance during isoproterenol-induced cardiac hypertrophy. J Physiol Biochem. 2022 Feb;78(1):283-294. doi: 10.1007/s13105-021-00863-4. Epub 2022 Jan 13. PMID 35023023
Идентификаторы
NCT: NCT05687578 · PLI001