63 Clinical Trials for Various Conditions
This is a small pilot intervention trial in which we will collect preliminary data to demonstrate the feasibility of an intervention study.
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.
The goal of this clinical trial is to learn about whether indoor air quality will improve over time in homes where occupants receive personalized information about levels of health-relevant air pollutants that includes practical, budget-friendly, and culturally relevant recommendations on actions they can take to improve their home's air quality. The rationale for the investigators' approach is that a rigorous intervention study design will generate robust evidence on the value of the in-home environmental data. Participating homes in both the intervention and control groups will receive three, one-week Home Health Box deployments spaced six weeks apart. After each of the first two deployments, homes in the intervention group will receive a Home Health Report with personalized information about in-home levels of health-relevant air pollutants and cost-sensitive recommendations on actions occupants can take to improve their home's air quality. The investigators will (a) investigate whether and how air quality changes over time in control and intervention homes and (b) survey intervention households on the utility of the Home Health Reports.
Fine particulate matter \<2.5 µm (PM2.5) air pollution is the fifth leading risk factor for global mortality, with the largest portion of deaths due to cardiovascular disease (CVD). While several mechanisms are responsible, PM2.5-induced elevations in blood pressure (BP) may be relevant. Indoor portable air cleaners (PACs) are a novel approach to reduce exposure to PM2.5 and potentially lower blood pressure. The current study is being conducted to provide evidence that PACs reduce PM2.5 exposure and lower systolic blood pressure (SBP) in key patient populations.
The goal of this observational study is to compare the effects of air pollution exposure and nutrition between neighborhoods with high and low social vulnerability scores. The main questions this study aims to answer are: * Does living in a neighborhood with high or low vulnerability influence the response of the heart, lungs, and immune system to air pollution. * Does nutritional status alter the association between air pollution exposure and changes in the heart, lungs, and immune system. Participants (age 25-70 years) that live in neighborhoods ranked high or low on the Social Vulnerability Index (SVI) will take part in 3 visits. Each visit involves the following: * Measurements of heart activity, lung function, and blood to measure changes that may be caused by air pollution. * Questionnaires about the types of food eaten and activities that may modify exposure to air pollution. * Estimation of air pollution exposure using a study iPhone. Participants will carry a study iPhone with them for 24 hours at each visit. The study iPhone runs an application (app) that estimates the amount of air pollution each participant is exposed to. * Wearing silicone wristbands for a week before each study visit. Silicone wristbands absorb air pollutants and are later measured see the types and amounts of chemicals participants are exposed to.
This study seeks to understand the relationship between prenatal maternal air pollution exposure and offspring risk for ADHD and examine two potential -modifiable- mechanisms: prenatal maternal inflammation and offspring sleep problems. We will employ a longitudinal neuroimaging study design and leverage a well-characterized intergenerational cohort of Puerto Ricans to address prior literature's limitations. This will be the first study to use infant neuroimaging to disassociate the effects of prenatal pollution exposure from those of postnatal pollution exposure, adversity and disadvantage, and offspring genetic risk for ADHD.
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.
Using a focused implementation research framework, the EPIS (Exploration, Preparation, Implementation and Sustainment) model in a type-2 hybrid design, the study will be conducted in 3 phases: 1) A pre-implementation phase that will use the Exploration and Preparation domains of EPIS to: a) explore barriers and facilitators of Clean Fuel- Clean- Stove (CF-CS) use, and b) develop a culturally-tailored CM strategy for CF-CS use; 2) An Implementation phase that will use the Implementation domain of EPIS to compare in a cluster RCT of 32 peri-urban communities (640 households), the effect of CM vs. a self-directed condition (i.e. receipt of information on CF-CS use without CM) on adoption of CF-CS use; and systolic BP reduction; 3) A post-implementation phase that will use the Sustainment domain of EPIS to evaluate the effect of CM strategy vs. self-directed condition on sustainability of the CF-CS use in 640 households across the randomly assigned 32 peri-urban communities in Nigeria. The Lagos State University College of Medicine (LASUCOM) working with the MOH will oversee research coordination in Nigeria.
This clinical trial will conduct an educational intervention to promote knowledge of and preventive health behaviors related to personal air pollution exposure. Air pollution is n ubiquitous environmental exposure that is associated with harmful health effects including lung cancer. The educational intervention is comprised of 2 educational videos that include information regarding air pollution, health effects, and personal preventive health behaviors to reduce air pollution exposure and the use of a wearable air pollution sensor. The knowledge gained from this study may inform future research that will be designed to promote awareness of air pollution and its health effects.
Since air pollution contains harmful toxicants, it is important for potential exposure to indoor and outdoor air pollution to be considered as part of an overall health risk reduction strategy. This is a behavioral intervention to assess the effectiveness on an air quality education program in reducing exposure to air pollution and negative health effects. Trial participants will complete a pre-test and home air quality assessment tool. Then, they will participate in an educational module on air quality learn about suggestions to take to avoid exposure and complete a spot test. One month after the educational intervention, the participants will be contacted and asked qualitative questions to assess study effectiveness.
The purpose of this project is to study the effects of air pollution toxicants on pregnant mothers' immune health during and after pregnancy. Using already collected samples, this study proposes to evaluate changes in immune function in response to air pollution with the use of innovative technologies, to identify the drivers of immune dysfunction and potential modifiable factors, and to determine how these immune findings are associated with pollution exposure and outcomes of disease.
This study is a blinded randomized crossover efficacy trial (N=172 households consisting of 207 participants) of High Efficiency Particulate Air (HEPA) filtration in near-highway homes that lack mechanical air-handling systems. Households will be randomized to 30 days of either filtration or sham filtration followed by a 30 washout period with a subsequent 30-day period of the alternative assignment. Room air filters that are commercially available will be placed in the bedroom and living room of each home. The investigators will measure UFP and PM2.5 concentrations in 20% of the homes during filtration and sham periods and assess personal exposure in a subset of participants. The investigators will also assess chemical composition of particulate air pollution in 10 homes/year for exploratory purposes that could lead to future lines of research. The primary health endpoints will be participants' hsCRP and peripheral blood pressure, measures that the investigators have used in multiple observational studies of UFP as well as in pilot filtration intervention studies. Secondary biological measures that contribute to understanding biological pathways will be IL-6 (inflammation), D-dimer (coagulation), metabolome, central pressure and arterial stiffness. The primary intention to treat analysis will compare outcomes between HEPA filtration to sham filtration. The investigators will have 80% power to detect a difference of 0.6 mg/L in change in hsCRP and a difference in reduction in systolic blood pressure of 3.5 mmHg compared to participants who receive no filtration. Having participants serve as their own controls in the within-subject comparisons of intervention effectiveness increases statistical power and eliminates the possibility of baseline imbalances in demographic and clinical characteristics. A social science evaluation will inform final adjustments to the investigators' approach at the start and also assess participant acceptance and experience with the intervention at the end. The investigators' primary innovation is that this will be the first near highway HEPA intervention trial that is large enough and careful enough to be policy-relevant.
Fine particulate matter \< 2.5 microns (PM2.5) air pollution is a leading global risk factor for cardiovascular morbidity and mortality. PM2.5 presents a serious ongoing public health threat to patients living in highly-polluted countries (ex: China, India) where air quality is projected to remain extremely poor (far exceeding World Health Organization Air Quality Guidelines) for the foreseeable future. This study reviews the benefits of personal level intervention (wearing N95 respirator) over long term, to prevent clinical events among patients with cardiovascular disease.
Societies become increasingly urban - more than half the world's population now lives in cities. Urbanization elevates anthropogenic (man-made) exposure to air pollutants. A clear association exists between exposure to air pollutants and exacerbations (worsening) of pre-existing asthma, incidence of nighttime asthma, difficulties with asthma control and increased disease risk. In 2012, the Public Health Management Corporation's Community Health Data Base estimated that 19.4% of adults in Philadelphia had asthma compared to a national prevalence of 7%. Asthma has a clear temporal signal. A majority of asthma patients, up to 75%, reports nighttime awakenings due to worsened cough, wheeze and dyspnea. This time-of-day-dependent exacerbation of symptoms, coined nocturnal asthma, is associated with poorer disease control, more frequent medication, and higher asthma-related morbidity and mortality. Consequently, several pathophysiological mechanisms proposed for nocturnal asthma relate to circadian clock biology. Lung function oscillates over the course of 24 hours, peaking around noon and reaching its nadir during early morning hours. Concentrations of air pollutants show oscillating patterns in urban settings. In this clinical research study, the investigators start to address how spatiotemporal fluctuations in air pollutants relate to asthma. Mechanistically, the investigators wish to address the hypothesis that microRNAs (miRs) act as interface between asthma phenotypes, circadian clocks and environmental exposure.
This study evaluates the impact of a solar lighting system on kerosene lamp use, levels of indoor air pollution, and health in women living in rural Uganda. Half of the participants will receive the lighting systems immediately, while the other half will receive them after an 18 month delay.
This observational study recruits healthy individuals who have been routinely taking high amount (at least 3 g/wk) of dietary eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and those who don't, and examines the efficacy of dietary EPA and DHA in ameliorating the cardiopulmonary effects of exposure to ambient air pollution.
Primary objective of this project is to measure the impact of passive control and active control systems on indoor pollution that is directly or indirectly related to ambient air pollution (smog). The first goal will be to measure baseline parameters for 50 homes, including information about the building, ventilation characteristics, pollution levels (indoors and outdoors), and occupant survey information. In a subset of these homes, either passive or active control systems will be installed and the impact of these systems on indoor concentrations. Participants will be enrolled on a rolling basis (5-15 persons studied at a given point in time) over a 16-month period. Participants will be followed for approximately 5 weeks and data obtained at three points in time: at enrollment (day 1 of study), after 1 week (baseline verification) and after four weeks with the control system in the home (at the end of study week 5).
Background: Asthma and obesity are public health crises that have concurrently risen over the past decades, affecting millions of children in the United States and disproportionately affecting low-income minority children in urban areas. The same children at highest risk for asthma and obesity also have greater exposure to indoor and outdoor pollution. Emerging evidence suggests that obesity may confer increased susceptibility to health effects of air pollution. Methods: Aiming to provide causal-level evidence of these observational findings, we propose a home intervention study to 1) test whether targeted reductions of indoor Particulate Matter (PM) concentrations improve the respiratory health of overweight inner-city children with asthma more than that of lean inner-city children with asthma and 2) investigate mediators of susceptibility to indoor PM among overweight versus lean children with asthma. We will accomplish these aims using a 1:1 randomized controlled trial of 200 children with persistent asthma (half normal weight, half overweight) living in Baltimore City. Participants will be randomized to receive either two active air purifiers containing high-efficiency particulate air (HEPA) filters or two sham air purifiers with their filters removed. Implications: If the aforementioned observational findings are confirmed, implications will be directly relevant to the over 170 million children around the world now estimated to be overweight or obese.
The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.
The BREATHE (Behavioral Research of Environment and Air Pollution Through Education) study is a pilot randomized control trial comparing the efficacy of a classroom-based intervention to no intervention in helping middle-school students understand and make behavioral decisions about air pollution. This study is designed to evaluate the effectiveness of the classroom-based intervention on knowledge of air pollution, understanding of air pollution sources, and behavioral choices made to reduce both contributions to air pollution and personal exposure to air pollution. It has been well established that pollution is a racial and economic issue. Low-income areas with populations of predominantly people of color tend to be those with the highest rates of pollution and the largest particulate exposure. Creation of and exposure to this pollution is a key issue for the health of inhabitants of these areas, and of those in the broader surrounding areas. By developing, and assessing the effectiveness of, the investigators hope that the BREATHE study will give the investigators insights into how to better combat this higher exposure and reduce the health risks for those in high pollution areas. The study will take place in 4 visits over a period of 12 months. The hypothesis is that the classroom-based intervention will be effective in leading to behaviors that will reduce exposure to air pollution.
The purpose of this study is to determine whether reducing indoor exposure to NO2 and particles improves respiratory health in children with asthma.
Purpose: The purpose of this protocol is to understand how social factors such as psychosocial stress may modify how people respond to air pollution. Ultimately this will help us understand health disparities from poor air quality. Participants: Up to 40 healthy adults,18-33 years old with different perception of stress will participate and complete this study. Procedures (methods): Subjects will be exposed to clean air and to ozone ( 300ppb) for 2 hours in a controlled environment chamber. Cardiac, vascular, pulmonary and cognitive function will be evaluated pre, immediately post and 18 hr post exposure. The primary endpoint will be Heart Rate Variability . Secondary endpoints will include pulmonary function, analysis of blood clotting/coagulation factors, biomarkers of stress, cognitive function, radial artery pulse wave measurements and analysis of soluble factors present in plasma.
This study is about asthma and how the environment affects asthma. Scientists know that air pollution (such as cigarette smoke and other particles in the air) can make asthma symptoms worse. This research is being done to study how the health of a person with asthma responds to an air cleaner. The investigator hypothesize that an air cleaner will improve the health of persons with asthma.
The study hypothesis is that drinking different juices will affect the body's responses to air pollution. Subjects will be exposed to air pollution during a 2-hour car ride on the NJ (New Jersey) Turnpike. Each subject will be asked to do this twice. Before one car ride, the subject will be asked to drink orange juice. Before the other car ride, the subject will be asked to drink beet juice. Samples of blood and exhaled breath will be collected before, immediately after, and 24 hours after each car ride. Levels of nitrites/nitrates will be measured in the blood and breath.
Exposure to ambient levels of air pollution increases cardiovascular morbidity and mortality. Advanced age is among the factors associated with susceptibility to the adverse effects of air pollution. Dietary fatty acid supplementation has been shown to decrease cardiovascular risk through multiple mechanisms. This study evaluated the efficacy of supplementation with marine fish oil or olive oil in protecting against cardiovascular effects induced by controlled exposure of middle-aged healthy volunteers to concentrated ambient air pollution particles. Subjects (ages 50 to72 years), were randomly assigned to receive 3 g/d of fish oil (1.2 g eicosapentaenoic acid and 0.82 g docosahexaenoic acid), or olive oil (3g/d) for 28 d. Subjects were then exposed to concentrated ambient air pollution particles or filtered air for 2 hr on sequential days. Heart rate variability (HRV), plasma lipids, coagulation markers, and endothelial function measured by flow-mediated dilation of the brachial artery (FMD) were assessed pre-, immediately post-, and 20 hr post-exposure.
The purpose of this study is to examine if the ingestion of a standard dose of sildenafil enhances the athletic performance of competitive athletes when exercising in a high pollutant environment verses a low air pollutant environment.
Community based studies have shown increased cardiovascular mortality associated with acute exposures to particulate air pollution. Electrocardiographic changes have also been reported in animals exposed to particles in controlled conditions. We have hypothesized that cardiovascular patients may experience life-threatening arrhythmias associated with particulate air pollution episodes. Implanted cardioverter defibrillator (ICD) devices continuously monitor the heart rhythm, and on detecting arrhythmias can initiate interventions. These devices provide a passive, continuous monitor of cardiac arrhythmias. We are assessing the association between community exposures to air pollution measured by ambient monitors and these cardiac arrhythmias detected by implanted cardioverter defibrillator devices.
Alaska Native children experience a high burden of respiratory disease, especially those in the Yukon-Kuskokwim (YK) Delta. Studies have shown that things like wood stove use, poor ventilation, and indoor tobacco smoke exposure can lead to poor indoor air quality inside the children's homes. This leads to more frequent and more severe respiratory infections in children. In the Yukon-Kuskokwim (YK) Delta, it's common for homes to have exposure to woodstoves and tobacco use. Both of these activities affect indoor air quality in homes. We know that high efficiency particulate air (HEPA) purifiers can reduce particulate matter and make air quality better. One way that we measure air quality is through particulate matter (PM2.5). One of the few studies that looked at this in the YK Delta found that PM2.5 levels that were nearly twice as high as homes with woodstoves in other states. We believe it is important to reduce the PM2.5 in YK Delta homes. However, the few studies that looked at HEPA purifiers in rural Alaska did not include homes where smokers lived. We know that breathing air with PM2.5 harms the lungs. We also know that HEPA filters can reduce PM2.5, which can mean reducing cough and wheeze in people with chronic lung conditions. We want to learn how HEPA filters work in homes with woodstoves or where a smoker lives, as it's likely these homes may have more PM2.5 than other homes. We expect that using HEPA filters will make the indoor air better and will mean decreased respiratory symptoms. We plan to include 15 households with a child less than 5 years old in the family. Households that join will be asked to: * Set up study equipment in their homes. * Run the study equipment for 12 weeks and do a weekly report of child's respiratory symptoms by phone or text. * Return the air-quality monitor equipment to the study team and keep the HEPA filters.
This double-blind, randomized, crossover trial aims to test the hypothesis that longer-term indoor air filtration intervention can slow atherothrombosis progression by reducing indoor fine particulate matter (PM2.5) exposure in adults with ischemic heart disease history.
The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. The exposure visits will be at least 2 weeks apart. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.