Harmful Algal Blooms
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Red Tide. Базовые параметры: от 18 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
Health Outcomes Associated With Algal Blooms of Cyanobacteria and Red Tide in in Florida: Long-Term Health Impacts of Harmful Algal Bloom Exposure, Phase 2
Обзор
The purpose of this study is to compare the frequency of symptoms, exposure and health impacts in persons living in areas where they are exposed to bloom and non-bloom periods of cyanobacteria and red tide in Florida.
Подробное описание
Florida has experienced multiple harmful algal blooms during the past several years of two predominant types of Florida red tides occur in the Gulf of Mexico and are due to proliferation of the dinoflagellate Karenia brevis which produces a suite of highly irritative compounds known as brevetoxins. Human illness is primarily due to inhalation of aerosols, which results in a well-characterized syndrome of respiratory tract symptoms due to the irritative effects of brevetoxin.
The proposed study will utilize a case-control approach to compare symptom frequency during bloom and non-bloom period sampling to compare exposures and health impacts. In addition, for the exposed group, comparison of bloom cell density will be examined. As in our previous study, sampling locations will include Fort Myers region, Stuart, and communities around Lake Okeechobee (for example Clewiston and Indiantown). Continuing data collection sites will include: The Volunteers in Medicine Clinic (VIM) in Stuart, Public Health Department in Clewiston, Florida Public Works Department in Cape Coral, and FAU Clinical Research Unit in Boca Raton, FL.
Первичные конечные точки
- To correlate self- reported symptom occurrence with recreational/occupational cyanotoxin exposure (measured in air and water environmental samples) and cyanotoxin levels in blood, nasal swab [Срок оценки: 2 years]
Вторичные конечные точки (4)
- Continue the study of previously enrolled cohort participants prospectively to determine whether long-term effects can be attributed to exposure to microcystins and brevetoxins (Florida Red Tide). [Срок оценки: 1 year]
- Recruit and establish new study participants on the West Coast of Florida (coastal Lee County) to further study the health effects of exposure to Red Tide. [Срок оценки: 1 year]
- Apply novel approaches to measure biomarkers in samples included in the biobank repository and maintained in the FAU Health Clinical Research Unit using using logistic regression and Generalized Linear Mixed Models (GLMM). [Срок оценки: 2 years]
- Analysis of data collected during our previous studies in 2016, 2018, and 2020-2023 to explore risk factors that potentially increase the susceptibility to the respiratory impacts of harmful algal bloom toxin exposure. [Срок оценки: 2 years]
Критерии участия
Критерии включения
- 18 years or older
- live, visit, and/ or work in the following Florida counties: Indian River, St. Lucie, Charlotte, Collier, Hendry, Hillsborough, Lee, Manatee, Martin, Monroe, Okeechobee, Palm Beach, Pasco, Pinellas, Indian River, and/or Sarasota
- able to read and understand English
Критерии исключения
- unable to independently consent
- younger than 18 years old
- prisoner
- pregnant women
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Случай-контроль
Центры проведения
США · 1 центр
- University of Central Florida — Multiple Locations
Идентификаторы
NCT: NCT07091058 · STUDY00007298