Clinical Research Directory

Cadmium Exposure During Pregnancy and Fetal Growth

Cadmium is a toxic heavy metal naturally present in the environment, whose human exposure has increased over recent decades due to diffuse anthropogenic contamination, particularly related to industrial activities and the use of mineral phosphate fertilizers in agriculture. Cadmium is characterized by its bioaccumulative properties and well-established toxicity, including renal and bone damage and carcinogenic effects. In pregnant women, several animal and human cohort studies have shown that cadmium can cross the placental barrier and accumulate in placental tissue. Placental cadmium exposure has been associated with impaired placental function and adverse perinatal outcomes, including fetal growth restriction and increased neonatal morbidity. In the general population without occupational exposure, diet represents the main source of cadmium exposure, apart from tobacco smoking. Fetal growth, commonly assessed through birth weight adjusted for gestational age, is a major determinant of neonatal and long-term health outcomes. This monocentric prospective pilot study aims to assess fetal exposure to cadmium during pregnancy using placental cadmium concentration as a biomarker. Placental samples will be collected at delivery from women giving birth at Amiens University Hospital, and cadmium levels will be measured using inductively coupled plasma mass spectrometry. The association between placental cadmium concentration and fetal growth will be explored. Fetal growth will be evaluated using birth weight adjusted for gestational age, expressed as a standardized z-score. Maternal urinary and blood cadmium concentrations will also be measured to characterize maternal exposure and explore correlations between biological matrices. Placental efficiency, defined as the fetal-to-placental weight ratio, will be assessed as an indicator of placental function. The results of this pilot study will provide preliminary data to inform future larger-scale epidemiological and mechanistic studies on prenatal cadmium exposure and pregnancy outcomes.

Ambient Air and Noise Effect on Cardiovascular Health Risk and Lifestyle Intervention to Attenuate It (METSGREEN)

This study, combining both an observational study and an interventional clinical trial, aims to assess how exposure to ultrafine particulate matter (PM0.1) and noise pollution affects the risk of cardiovascular diseases and metabolic disorders in 45-64-year-old residents of Kaunas City, and whether lifestyle interventions-specifically physical activity in green spaces and the Mediterranean diet-can help reduce these risks. In the observational part, approximately 1,000 randomly selected 45-64 years men and women living in private households will complete an anonymous online health and lifestyle questionnaire. The clinical interventional trial will include 180 participants, who agreed to participate in the clinical study and, who meet specific health criteria. The main questions the study seeks to answer are: whether increased exposure to PM0.1 and noise is linked to higher cardiovascular and metabolic risk; and whether short-term healthy lifestyle changes can improve biological markers associated with these conditions. Participants in the clinical trial will be randomly assigned to one of three groups: (1) control group continuing usual habits, (2) physical activity group at least 30-minute daily walks in green spaces, or (3) group adherence to a Mediterranean diet. They will have two visits to the clinic for health surveys: * Wear a wristband sensor for 7 days to monitor physical activity, heart rate, and sleep quality * Visit a clinic on Day 1 and Day 8 for measurements (blood pressure, waist circumference, body composition) and give blood samples for biomarker analysis. This research will provide new evidence on environmental health risks and practical recommendations for reducing the burden of metabolic and cardiovascular diseases.

Effect of a Dietary Supplement Versus Placebo on Serum PFAS Levels in Male Firefighters

This study is designed to evaluate the effect of a probiotic dietary supplement containing Streptococcus salivarius on serum PFAS levels in male firefighters with documented occupational PFAS exposure, following twice-daily use over a 12-week period.

Weight Loss and Endocrine Disrupting Chemicals (EDCs): Lifestyle Interventions to Lose Weight and Reduce EDC Exposure in Individuals With Overweight/Obesity

The goal of this study is to examine the relationship in individuals with overweight/obesity and endocrine disrupting chemical (EDC) exposure through a two-armed, randomized clinical trial. The main questions this study aims to answer are: 1. If MM's 12-week EDC intervention program (EDC testing and report-back, EDC reduction curriculum) can reduce weight? 2. If a 12-week validated digital weight loss program can reduce EDC exposures? 3. What is the effectiveness of the two interventions at reducing weight and urinary EDC metabolites? Participants will be assigned to one of these two arms. Participants will collect their urine and blood samples pre- and post-intervention, and will take a comprehensive exposure survey before sending back their samples. This exposure survey will ask about participant's weight loss literacy, environmental health literacy, product use, diet, and lifestyle behaviors.

Detection of Microplastics in Human Granulosa Cells and in the Follicular Fluid of Women Undergoing ICSI Treatment

Plastic products have been used ubiquitously in the modern world for many decades - for example as packaging materials, textile fibers or molded parts. The general use and especially the improper disposal lead to enormous environmental pollution almost everywhere on earth. Microplastics mainly originate from fragmentation of larger plastic objects or can be produced directly for the use in e.g. cosmetics or industrial dyes. Microplastics have already been detected in fresh- and seawater, soil, food, but also in human blood and urine. The accumulation of microplastics in ovarian and testicular tissue in humans has not yet been investigated.

Table-Top Water Pitcher to Reduce Arsenic Exposure Among Well Users in New Hampshire

The goals of this clinical trial are to: 1. gather preliminary data on the effectiveness of a table-top water pitcher filtration system in reducing arsenic exposure among individuals using private wells with elevated (\>5 μg/L) arsenic concentrations, and 2. identify the factors influencing implementation of the filter intervention (uptake and sustainability) and barriers and facilitators to its use. The main questions it aims to answer are: Do water and urinary arsenic concentrations change from baseline to Week 4 of the water pitcher intervention? Are changes in arsenic concentrations maintained during the eight-week sustainability period? * Which factors facilitate or impede uptake, use, and sustainability of the intervention? * Are household income and/or home ownership associated with sustained filter use? Participants will: * Receive a free 12-cup water filter pitcher and cartridge replacements * Use the pitcher filtration system, including replacement of filter cartridges, per manufacturer recommendations * Collect and mail water and urine samples at baseline, 4 weeks, and 12 weeks * Complete online questionnaires at baseline, 4 weeks, and 12 weeks

PFAS Clinical Trial

The purpose of this study is to evaluate whether treatment with cholestyramine for either one, two, three, or four months (up to 120 days), meaningfully influences per- and polyfluoroalkyl substances (PFAS) removal from the body.

Assessing the Effectiveness of Heat Adaptation Digital Messages From Primary Care Providers to Their Patients on the Change in Behaviour for Heatwave-related Preparedness

Extreme heat events pose a significant health threat in Canada, as demonstrated by the 2021 heat wave that claimed over 600 lives in Western Canada. Most heat-related deaths occur indoors and are preventable. Primary care providers (PCPs), who serve 88% of Canadians, are uniquely positioned to identify and support at-risk individuals. Heat Smart, in alignment with Heat Alert and Response Systems (HARS), aims to bridge the gap between primary care and public health to enhance community resilience and reduce health inequities related to extreme heat events. This randomized control trial in Eastern Ontario will examine whether patients receiving tailored digital health messages from their family physician or nurse practitioner change their behaviour to protect themselves from extreme heat-related illness. The Heat Smart study will: * Assess risk: Analyze electronic medical records and patient surveys to identify vulnerable individuals. * Deliver tailored messages: Send personalized digital guidance via e-mail or text, offering heat safety advice and local resource information in English and French. * Issue early warning alerts: Notify at-risk patients of upcoming heat events, prompting action. * Evaluate impact: Use surveys and health data to measure effectiveness in reducing heat-related health impacts. Short-term outcomes include increased awareness and preparedness among patients about heat-related health risks. Long-term goals involve scaling the intervention across Canada to reduce heat-related illnesses, enhance social connectedness, and decrease healthcare utilization.

Generation Victoria Cohort 2020s: A Statewide Longitudinal Cohort Study of Victorian Children and Their Parents

Generation Victoria (GenV) is a longitudinal, population-based study of Victorian children and their parents that will bring together data on a wide range of conditions ,exposures and outcomes. GenV blends study-collected, study-enhanced and linked data. It will be multi-purpose, supporting observational, interventional, health services and policy research within the same cohort. It is designed to address physical, mental and social issues experienced during childhood, as well as the antecedents of a wide range of diseases of ageing. It seeks to generate translatable evidence (prediction, prevention, treatments, services) to improve future wellbeing and reduce the future disease burden of children and adults. The GenV Cohort 2020s is open to all children born over a two-year period, and their parents, residing in the state of Victoria Australia. The GenV Cohort 2020s is preceded by an Advance Cohort of children born between 5 Dec 2020 and 3 October 2021, and their parents. This comprises all families recruited at GenV's Vanguard hospital (Joan Kirner Women's and Children's) and at birthing hospitals throughout Victoria as GenV scaled up to commence recruiting for the GenV Cohort 2020s. The Advance Cohort have ongoing and full participation in GenV for their lifetime unless they withdraw but may have less complete data and biosamples.

One Health Determinants of Rectal Colonization by ESBL-Producing Enterobacterales in the Community

This multicenter cross-sectional observational study aims to determine the prevalence of rectal colonization by extended-spectrum beta-lactamase (ESBL)-producing Enterobacterales among community-dwelling adults in Argentina and to identify biological, clinical, sociocultural, occupational, and environmental factors associated with colonization. Participants will be recruited from sentinel healthcare centers and will undergo collection of rectal swabs, fecal samples, urine samples, and standardized epidemiological questionnaires. The study is based on a One Health framework and will evaluate potential determinants of antimicrobial resistance, including previous healthcare exposure, antibiotic use, animal contact, occupational exposures, environmental conditions, water access, dietary habits, and pesticide exposure. Biological samples will be stored in an institutional biobank for future molecular, microbiome, resistome, and toxicological analyses. Findings are expected to improve understanding of community-associated antimicrobial resistance and support the development of preventive public health strategies.

Prenatal Education on Environmental Exposures During Pregnancy Study (PEEPS)

The purpose of this project is to reduce maternal environmental exposures to toxicants through a patient education program designed to help pregnant women learn about exposure through consumption of contaminated seafood and to be able to use the lessons they learn to have a better understanding of risk.

Clinical Utility of LIBS Multi-Element Imaging and the IFF Algorithm in Chronic Lung Diseases

PNEUMO-LIBS is a multicenter, non-interventional observational study designed to evaluate whether multi-element tissue imaging by Laser-Induced Breakdown Spectroscopy (LIBS), combined with an artificial intelligence-based analysis tool called Interesting Features Finder (IFF), may help physicians better understand the possible causes of chronic lung diseases. The study focuses on adult patients with chronic lung diseases for which a lung biopsy has already been performed as part of routine medical care. These diseases include diffuse interstitial lung diseases, pulmonary granulomatoses such as sarcoidosis, and emphysema, especially when an environmental or occupational exposure is suspected but not clearly demonstrated. Some chronic lung diseases may be influenced by inhaled mineral or metallic particles, such as silica, aluminum, titanium, or other metals. However, these exposures are often difficult to document at the individual patient level. Standard clinical, radiological, and pathological investigations do not usually provide direct information on the presence and distribution of such elements within lung tissue. LIBS is an imaging technique that can detect and map chemical elements directly in tissue samples, including archived formalin-fixed paraffin-embedded biopsy blocks. In this study, lung biopsy samples will be analyzed with LIBS to search for elemental signatures that may be compatible with occupational or environmental exposures. The IFF algorithm will then be used to help interpret the LIBS data and identify rare or unexpected elemental signals. The study does not require any additional biopsy, blood test, imaging examination, treatment, or hospital visit for participants. It uses tissue samples and medical data already collected during routine care. The results of LIBS and IFF analyses will be presented to the treating physician or investigator, who will complete standardized online questionnaires at three time points: before receiving the LIBS results, after receiving the LIBS report, and after receiving the IFF-assisted interpretation. The main objective is to assess the perceived clinical utility of LIBS imaging for physicians, particularly regarding etiological understanding, possible occupational disease recognition, and prevention-oriented reasoning. Secondary objectives include assessing the added value of the IFF algorithm and evaluating the feasibility of a centralized multicenter workflow for sample transfer, LIBS analysis, IFF processing, result reporting, and questionnaire completion. The study aims to include approximately 70 patients across several French hospital centers. Its results may support the development of future diagnostic, occupational health, and environmental medicine approaches, without modifying the medical care of participants during the study.

Plastic Waste and Human Health Effects in Guatemala

Ecolectivos is a type-1 hybrid-effectiveness-implementation study that uses a village-level cluster randomized controlled trial design. The goal of this study in rural Guatemala is to assess intervention strategies to reduce plastic burning in 8 intervention villages compared to 8 control villages. The intervention group participants will participate in 12 weekly behavioral working group sessions; the control group will not receive any specific activities. Two hundred women of reproductive age and other community members from these villages will be enrolled in each group. Data will be collected via interviews, focus groups, air pollution sampling, plastic waste collection, urinary biomarker assessments, and ambient air sampling. Program evaluation and results dissemination will occur in the last year of the project.

The IGNITE Study on Concentrated Investment in Black Neighborhoods

Black Americans in the US fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities culminate in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place-based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood microclusters, with a total of 720 adults. The investigators hypothesize that this "big push" intervention will have significant impact on overall health and wellbeing.

Human Observatory Study

The Human Observatory Study is a prospective observational and ecological surveillance study building a continuously-updating world model for human health, disease, and death at the individual and population level. Individual multi-system clinical data from enrolled participants are linked to a continuously-ingested ecological data infrastructure spanning environmental exposures, social determinants, genealogical and family history records, mortality data, and population health databases at geographic resolutions from home address to global scale and beyond. The resulting model generates individual screening recommendations informed by population-level causal estimates, and population-level causal forecasts anchored by present-timepoint individual clinical biology. This linkage creates a feedback architecture designed to improve both simultaneously.

A Personalized Biomonitoring and Report-back Intervention to Reduce Exposure to Endocrine Disrupting Chemicals

The goal of this clinical trial is to learn if a personalized biomonitoring report-back and educational intervention in child-bearing aged men and women can reduce endocrine disrupting chemicals (EDCs) measured in urine, increase participants' understanding of environmental health (environmental health literacy; EHL), increase their readiness and behaviors to reduce exposures, and improve their well-being. The intervention includes EDC testing and exposure report-back, a self-directed online interactive curriculum with access to live coaches, and an online forum. The investigators hypothesize that the intervention will be more effective than EDC testing and report-back alone at reducing EDC exposures (behavior change and metabolite concentrations), as well as increasing EHL, readiness to reduce exposures, and well-being.

Monitoring Environmental Exposures and Behavioral Change

The goal of this study is to examine what effect real-time feedback on particulate matter (PM) air pollution levels has on risk recognition and behavior. The hypothesis is that real-time exposure feedback will change perceptions of risk and increase behaviors that avoid exposure to environmental risks. At least one representative household member in participating households will complete a questionnaire to fully understand environmental concerns, risk perceptions, and related behaviors. Half of the households will have PM monitors that continuously display real-time concentrations and an indication of the hazard level. The other participants will have the same device but it will only display the date and time. All participants will then be surveyed again: (a) immediately after sampling is complete (i.e., when the devices are removed from the home), (b) after 3 months and, (c) after 6 months. The goal of repeated surveys is to determine changing understanding of risks, how participating in research and/or receiving real-time exposure data may have changed participant behavior, and what concerns they continue to have. The questionnaire will include questions with categorical and/or quantitative answers (e.g., frequency of specific behaviors) so that changes in risk perception and behavior can be effectively analyzed.

The Barts Charity Children's Environmental Health Clinic

The study will be based from a newly formed NHS service, the children's environmental health service. Participants will be children with a known chronic respiratory condition. Participants will undergo personal environmental exposure monitoring as well as home environmental assessments, before personalised exposure reports will be provided including a summary of their exposure and advising mitigation strategies based on exposure patterns and behaviours. The monitoring will be repeated after introduction of mitigation strategies. This will allow a comparison of the effectiveness of each method of mitigation.

Change in Knowledge After Receiving Personal Air Pollution Results

Personal exposure to air pollution results from the interaction of individual time-activity patterns with levels of air pollution that vary over time and space. The increasing use of personal monitors capable of measuring geo-located and real-time air pollution in epidemiologic studies requires novel human subject considerations. Reporting individual exposure data back to participants is considered best practice in environmental health research using biomonitoring data and is beneficial to both study participants and researchers. The investigators believe that providing individual results of personal air monitoring may be more informative than biomonitoring data given the potential to increase participants' awareness of their exposure, identify specific locations and times of elevated exposures, and inform behavioral changes to decrease exposure and risk of adverse health outcomes.

The IGNITE for Kids Study on Concentrated Investment in Black Neighborhoods and Child Health and Well-Being

Black children and adults in the United States fare worse across nearly every health indicator compared to White individuals. In Philadelphia, the location of this study, these health disparities result in a stark longevity gap, with average life expectancies in poor, predominantly Black neighborhoods being 20 years lower than in nearby affluent, predominantly White neighborhoods. The investigators will conduct a cluster randomized controlled trial (RCT) of a suite of place- based and financial-wellbeing interventions at the community, organization, and individual/household levels that address the social determinants of racial health disparities. At the community level, the investigators address underinvestment in Black neighborhoods by implementing vacant lot greening, abandoned house remediation, tree planting, and trash cleanup. At the organization level, the investigators partner with community-based financial empowerment providers to develop cross-organizational infrastructure to increase reach and maximize efficiency. At the individual/household levels, the investigators increase access to public benefits, financial counseling and tax preparation services, and emergency cash assistance. The investigators will test this "big push" intervention in 60 Black neighborhood micro-clusters, with a total of 480 children. The investigators hypothesize that this "big push" intervention will have significant impact on children's health and wellbeing.

Impact of Environmental Exposures on Tumor Risk in SDHx-mutation Carriers

The primary objective of the PGL.EXPO-2 study is to test the hypothesis that exposure (occupational, environmental and/or domestic) to succinate dehydrogenase inhibitors (SDHi) could contribute to tumor emergence in subjects carrying a germline mutation in one of the SDHx genes.The primary endpoint will be the proportion of subjects (cases or controls) exposed to SDHi and the association with paraganglioma risk. In addition, a blood sample (10 ml on EDTA) will be proposed to the participants to the study

Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx Paraganglioma

The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to precise methodology of a case-control study designed for testing the impact of environmental and professional exposures on the tumoral risk in SDHx-mutation carriers

Developmental Impacts of Microplastics Exposure in Early Life

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 1 or 3 months postpartum living in Baltimore, Maryland. 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

A Study to Assess the Efficacy of Public Health Campaigns in Reducing Lead Exposure

This clinical trial aims to evaluate the effectiveness of targeted public health campaigns in reducing lead exposure among adults living in urban communities with known environmental lead hazards. Lead exposure remains a significant public health concern, particularly in older urban neighborhoods with aging infrastructure and legacy contamination. Despite existing regulations and remediation efforts, many communities continue to experience elevated blood lead levels, especially among vulnerable populations. The study will compare the impact of an intensive, multi-modal public health campaign-featuring community workshops, educational materials, and home intervention resources-against standard municipal information dissemination. By assessing changes in blood lead levels and lead-related knowledge, attitudes, and behaviors over a 12-month period, the trial seeks to determine whether enhanced public health outreach can more effectively reduce lead exposure and promote safer practices. The findings will inform future strategies for community-based environmental health interventions.