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Environmental Exposure clinical trials

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NCT ID: NCT06384625 Not yet recruiting - Clinical trials for Cardiovascular Diseases

Air Pollution Intervention for Cardiovascular Patients

Start date: June 1, 2024
Phase: N/A
Study type: Interventional

This pilot study (n=20) is a prospective evaluation of the implementation of an indoor air pollution intervention among patients who have undergone recent percutaneous coronary intervention procedures. The intervention, called Air Improvement and Real-time Monitoring for Wellness through Interactive Strategies and Education (AIRWISE), is focused on improving indoor air quality through air filtration, education, and behavioral recommendations. All participants will receive the AIRWISE intervention with the objective of evaluating acceptance and use of the individual intervention components. This implementation study will inform the submission of a larger NIH proposal for a randomized trial. The central study hypothesis is that an intervention program with educational strategies and visual behavioral cues will increase knowledge and awareness of air pollution exposures among the participants and lead to improved intervention compliance.

NCT ID: NCT06339450 Not yet recruiting - Clinical trials for Environmental Exposure

Real World Environmental Exposure Study With Healthy and Cystic Fibrosis Subjects

ExpoCF
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Cystic fibrosis (CF) is the most common autosomal recessive disease that leads to early mortality in Caucasians and affects around 7500 patients in France. Progression of the disease depends on pulmonary exacerbations defined as acute deterioration of respiratory symptoms which ultimately impair lung function and quality of life. Most frequently caused by lung bacterial infections, exacerbations' effects include increased cough, increased sputum production, increased use of antibiotics, dyspnea and decreased lung function. The phenotypic variability of CF suggests the implication of other contributors especially to the CF airway disease. Beside genetic and epigenetic alterations, environmental factors - e.g tobacco smoke, air pollution, temperature changes, food intake - appear as relevant candidates. A previous review has discussed current knowledge on the effects of air pollution on the course of CF disease. Although scarce, the existing epidemiological andexperimental literature suggests a link between exposure to air pollutants and adverse health effects.Although scarce, the existing epidemiological and experimental literature suggests a link between exposure to air pollutants and adverse health effects. The EU sponsored REMEDIA project (Impact of exposome on the course of lung diseases, Grant agreement ID 874753) contributes to the understanding of the influence of the exposome on chronic obstructive pulmonary disease (COPD) and CF. Objective of work package 3 within the REMEDIA project is the development of a mobile environmental sensor toolbox that is capable to assess the external exposome. The biomarkertoolbox was developed and tested in a proof-of-concept study carried out in healthy volunteers. The next step is to validate the collectionof exhaled breath condensate (EBC) in a real-life study. In this aim, the objective of the present study will be to assess the feasibility of EBC collection in CF patients and healthy individuals

NCT ID: NCT06325358 Not yet recruiting - Clinical trials for Multiple Sclerosis, Relapsing-Remitting

the EXPOSITION Study

EXPOSITION
Start date: April 15, 2024
Phase:
Study type: Observational

This is a cross-sectional study to evaluate the variation of biological biomarkers of oxidative stress and inflammation in response to the external exposome, in people with Multiple Sclerosis (pwMS).The objective is to study the variation of biological biomarkers of oxidative stress and inflammation in response to external exposome in pwMS, controlling for other biomarkers (cytokine, neurofilaments, microbiome), gender, age, anthropometric measurements, vitamin D levels and medical history. Specifically, the variation of microRNAs is defined as the primary outcome, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome. Following the functional exposome approach:(1)Information on a pwMS sample about socio-demographic characteristics and medical history will be collected and specific components of the (2) On the same pwMS sample, the internal exposome variation will be measured. MicroRNA levels and gut and nasal microbiota alpha- and beta-diversity and relative bacterial abundances will be considered as biomarkers of oxidative stress and inflammation. At the same time, cytokines and neurofilament proteins (NfL) will be measured as biomarkers of neurodegeneration and axonal damage. Adults (≥ 18 years) pwMS, with relapsing-remitting course, diagnosis of MS according to 2017 McDonald criteria and residing in Pavia or Milan (Italy) will be included. Potentially eligible pwMS will be screened by a neurologist expert in MS who will verify that all the inclusion criteria will be fulfilled. To validate variation among 7 selected MS diagnostic miRNA, in response to urban air pollution, urbanization, lifestyle and quality of life components of the external exposome, the differential expression (ΔCT) for each miRNA will be considered as the outcome measure. Two hundred eligible pwMS who meet the inclusion criteria and sign the informed consent will be included in the study, to consider 15% dropout at the blood sampling stage.

NCT ID: NCT06315140 Recruiting - Clinical trials for Environmental Exposure

Assessing and Addressing Community Exposures to Environmental Contaminants

Start date: February 16, 2023
Phase:
Study type: Observational

The purpose of this study is to build on our equitable, eight-year Tribal-academic partnership with the Ramapough Nation of northern NJ to advance tradition-centered farming practices and management strategies supporting sustainable food systems to relieve local food insecurity and nutritional deficiency, prevent disease and promote health. Furthermore, assessing the extent of environmental contamination, individual toxicant burdens and micronutrient levels and health disorders in Ramapough Tribal members of both sexes as outlined in the following: - Collect in-person/online survey information on demographics, health and food intake, nutrition, food security, and psychosocial stressors, and perform core anthropometric measurements (i.e., height, weight, body mass index, body circumference and blood pressure) at enrollment on Tribal members to inform health promotion strategies and community actions. - Determine individual-level contaminant burdens and micronutrient concentrations (e.g., iron, calcium, folate, vitamins) in urine and blood from surveyed (sub-aim 1a) Ramapough Turtle Clan volunteers. - Test soil, plants and surface water where Turtle Clan residents live, recreate and attend church in Ringwood, NJ using a community-based, citizen scientist approach.

NCT ID: NCT06266533 Recruiting - Clinical trials for Environmental Exposure

Dismantling the U.S. Social Norm of the "Kids' Food" Archetype (REACH Project)

Start date: February 21, 2024
Phase: N/A
Study type: Interventional

This project is the first stage of a health promotion campaign to shift social norms about marketing and feeding children ultra-processed foods. Embedded within a longitudinal ethnographic study using photo-elicitation techniques, mothers of preschool-age children will be randomly assigned to arts-based or traditional education about ultra-processed food.

NCT ID: NCT06107933 Recruiting - Infant Development Clinical Trials

Developmental Impacts of Microplastics Exposure in Early Life

DIMPLE
Start date: October 1, 2023
Phase:
Study type: Observational

The goal of this observational study is to characterize and evaluate micro- and nano-plastic (MNP) exposures among mothers and infants in mother-infant dyads one-month postpartum living in Denver and Boulder, Colorado. The main questions it aims to answer are: - What MNPs are present in breastmilk and maternal blood samples and in their infants stool sample? - Are there associations between amount of maternal MNPs in breast milk and mass of MNP particles in infant stool? - Which environmental and lifestyle factors are most predictive of maternal MNP burden? - Is infant exposure to MNPs associated with birth weight and postnatal growth trajectories? Participants will: - Complete several questionnaires assessing medical histories, lifestyle factors, environmental exposures, eating behaviors, etc. - Provide biological specimens including: maternal blood, stool, and breastmilk; infant stool - Clinical visit to have anthropometric measures documented including maternal height and weight, infant weight, length, and skin-fold thickness

NCT ID: NCT06083415 Recruiting - Clinical trials for Environmental Exposure

Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context

PENELOPE
Start date: May 15, 2023
Phase: N/A
Study type: Interventional

Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. In a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved. Descriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome. The PENELOPE clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters. The data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.

NCT ID: NCT05972187 Recruiting - Healthy Clinical Trials

The Effect of IEQ on Cognition and Health

IEQ-HUM
Start date: June 18, 2023
Phase: N/A
Study type: Interventional

The goal of this study is to learn about the effect of heat and humidity on cognition and health. The main question[s] it aims to answer are: type of study: interventional participant population: 20-40years, both gender, healthy Participants will be exposed for 4 different sessions of 8 hours at a time, to 32˚ C or 25˚ C in combination with relative humidity of 30 %RH or 70 %RH.

NCT ID: NCT05930626 Completed - Cancer Clinical Trials

Biomarkers of Acrylamide, Glycidol, POPs, PFAS and Disease Outcomes and OMICs Signatures

Start date: January 1, 1997
Phase:
Study type: Observational [Patient Registry]

The aim of the project is to assess the associations between biomarkers of acrylamide and glycidol exposure and disease outcomes in a case-cohort study based on two prospective cohorts with biobanks. The investigators also aim to assess the exposure-affected OMICS signatures and molecular pathways underlying disease development (specifically cardiovascular diseases such as myocardial infarction and stroke and cancer such as breast-, endometrial and colorectal cancer) for these exposures along with persistent organic pollutants (POPs) and per- and polyflouroalkyl substances (PFAS) using a prospective cohort study utilizing and integrating various 'OMICs' technologies.

NCT ID: NCT05865782 Not yet recruiting - Physical Inactivity Clinical Trials

Reconstructing Schoolyards With Greenery to Increase Schoolchildren's Physical Activity and Mitigate Climate Changes

Start date: May 22, 2023
Phase: N/A
Study type: Interventional

By reconstructing schoolyards with greenery, physical activity levels among children can be increased at the population level and also mitigate health and environmental risks resulting from rising climate changes in urban areas. The overarching purpose of the proposed project is to: i. increase physical activity levels among school-aged children, independent of socioeconomic factors, and thus affect short- and long-term health outcomes on a population level ii. establish an evidence-based bottom-up approach for schoolyard reconstructions iii. evaluate the cost-effectiveness of schoolyard reconstructions with greening on health outcomes and its environmental impact