27 Clinical Trials for Various Conditions
To reduce the risk of adverse health problems associated with chronic exposure to pesticides, a randomized control study will evaluate a nurse-led integrated pest management (IPM) intervention in 88 child care centers serving socio-economically and ethnically diverse preschool-age children in four California counties. Positive changes in IPM knowledge, policies, practices, pests, and pesticide exposure will be assessed.
In the Lake Apopka, Florida area for over 50 years starting in the 1940s, organochlorine pesticides (OCPs) including 4,4'-dichlorodiphenyltrichloroethane (DDT), dieldrin, chlordane, toxaphene and more recently methoxychlor were sprayed on farmlands in order to control pests and to improve crop harvests. For most of those years, the farmworkers were exposed to the pesticides as part of their work. Because of their lipophilic (fat soluble) nature, these organochlorine pesticides (OCPs) are readily taken up into the body and not readily eliminated. Therefore, they can be detected in exposed individuals for many years after the exposure. There is some evidence that certain OCPs can cause or exacerbate medical problems in sensitive individuals. For example, exposure to some OCPs has been associated with development of Parkinsonism. Exposure to other OCPs has been associated with development of lupus erythematosus, an auto-immune disease. Other adverse effects of exposure to OCPs are endocrine disruption because some OCPs mimic estrogens and others mimic androgens, or may have mixed interactions with steroid receptors. In this research study the investigators aim is to test the blood from former farmworkers during the 1940s through the late 1970s who reside in the Lake Apopka area for OCPs and for the auto-antibodies. In addition, questionnaires will provide insight on their health status and health concerns.
Childhood leukemia is the most common type of childhood cancer and its etiology is largely unknown. Most case-control studies of childhood leukemia have reported elevated risks among children whose parents were occupationally exposed to pesticides or who used pesticides in the home or garden. Investigators at the University of California at Berkeley (UCB) conducted a case-control study of childhood leukemia in 35 counties in the San Francisco Bay area and the agricultural Central Valley of California. A major focus of the UCB study is to evaluate whether household or occupational exposure to pesticides increases the risk of childhood leukemia. Our collaboration provided additional funding to collect carpet dust samples for the measurement of pesticides and other chemicals. For 470 participants, we attempted to collect carpet dust using a special high volume small surface sampler (HVS3) vacuum and by taking dust from participants vacuum cleaner. As of July 2006, dust samples will be collected only from participant's vacuum cleaner. Samples were collected at a home visit approximately 3-6 months after the first in-person interview. We will also provide support for mapping of the crops (i.e., determining crop field boundaries and crop species) within 1200 meters (3/4 mile) of residences so that the residential proximity to agricultural fields treated with pesticides can be determined. We will conduct the epidemiologic analysis of pesticide and other chemical levels in carpet dust and risk of childhood leukemia. We will also evaluate whether residential proximity to agricultural pesticide use is associated with risk of leukemia. Further, we will conduct an Exposure Pilot Study that will include a subset of the study population. Two components of the Pilot Study will evaluate how well a used vacuum bag and a window sill wipe predict pesticide and other chemical concentrations in carpet dust samples collected with the more complicated HVS3 vacuum method. The third component will compare pesticides detected in carpet dust with pesticides predicted by geographic proximity to agriculture....
Parkinson's disease (PD) occurrence is higher in rural than in urban populations of industrialized countries. Epidemiologic and human tissue studies suggest that pesticides may be responsible for causing dopaminergic cell death at increased rates. While many pathophysiologic pathways may be involved in the neurodegeneration responsible for PD, genetic factors are likely to determine a general susceptibility to neurodegeneration.
Exposure and health study of pesticide and allergen exposures to pregnant women and children. Intervention study is planned after assessment is completed.
This project is aimed at better understanding how children living in agricultural environments are exposed to pesticides, and how such exposures can be prevented or reduced. The current project will characterize pesticide exposure pathways for children of farmworkers.
Child Care Health Consultants will provide an integrated pest management (IPM) intervention for \~30 family child care home directors. The intervention will include an educational component, collecting carpet dust samples, reporting back the pesticides identified in the carpet, and 7-monthly consultations to identify ways to reduce their exposure to pesticides and lower their long term health risks.
Background: - Multiple myeloma (MM), a type of cancer that affects the white blood cells, is often preceded by a precancerous disorder known as monoclonal gammopathy of undetermined significance (MGUS). Farmers and other agricultural workers have a higher risk of developing MGUS and MM, possibly because of their exposure to certain pesticides. Researchers are interested in studying biological specimens taken from participants in the Agricultural Health Study - specifically, pesticide applicators at least 50 years of age who do not have cancer- to better understand the development of MGUS and MM. Objectives: * To collect biological specimens from Agricultural Health Study participants for further research. * To examine the relationship between pesticide exposure and MGUS/MM. Eligibility: - Male pesticide applicators who are over 50 years of age, cancer-free, and participating in the Agricultural Health Study. Design: * Two groups of participants will complete the study: a general group and a smaller group of individuals who have been exposed to the pesticide diazinon. * All participants will receive an initial contact letter with information about the study, followed by a phone call to administer a screening questionnaire and arrange a home visit from a researcher within the next month. * Participants will receive by mail a urine specimen kit that will be collected at the home visit. * During the home visit, a study researcher will take blood samples and collect the urine sample, and will administer another questionnaire. * Participants in the group exposed to diazinon will have three home visits for the study: (1) prior to pesticide exposure, (2) the day after participants stop using diazinon, and (3) about 21 days after the second visit. The first visit will take place in the off-season from January to March; the second and third visits will be conducted between April and August. * No treatment will be provided as part of this study.
We propose to conduct a study to increase our understanding of farming practices and of the potential for previous exposure to DDT in North Carolina African American male agricultural workers, a group especially likely to have had high DDT exposure. Because of potentially widespread DDT exposure from agricultural activities, African American farmers and farm workers may be uniquely at risk for any associated health effects. However, little is known about levels of pesticide exposure in African American farming populations. Three hundred and eighty-nine African American men who are current or former farmers or farm workers will be asked to participate in the study. These men are members of the Supplemental Minority Cohort of the NCI/NIEHS/EPA Agricultural Health Study (AHS). The AHS is a prospective study of the potential health effects associated with agricultural exposures. Men in the supplemental cohort were recruited in 1996. At that time, they completed an enrollment questionnaire that focused on lifetime agricultural exposures, demographics, lifestyle factors and health. In this new study, a follow-up questionnaire will be administered by telephone by a trained interviewer to all men. Following the interview, the participant will be asked to donate a blood specimen, to have anthropometric indices (e.g., height, weight, waist and hip circumference, etc.) measured, and to have a top- and side view Polaroid photograph of their head taken during one visit to a central community location, such as the local church or health clinic. We will quantitatively document serum p,p'-DDE levels, correlate these with self-reported farming activities and DDT exposure, and describe the health status of these men. We will also correlate serum p,p'-DDE levels and androgen concentrations, since p,p'-DDE is thought to be a potent androgen receptor antagonist. This exploration of the potential link between levels is important because the demonstration of any subclinical physiological effects of p,p'-DDE would increase the plausibility of a wide range of health effects that have been postulated to be associated with the endogenous endocrine environment and the so-called endocrine disrupters. In addition, we will evaluate the relationship between several important physiological parameters which can be easily and accurately measured in serum, and physical characteristics including hair patterning and distribution of body fat in these African American men.
This study will collect information on the height and weight of women who participated in a 1998 study in Triana, Alabama, on the risk of breast cancer and benign breast disease in relation to environmental exposure to the pesticide DDT and similar chemicals. This additional information is needed to calculate the participants' body mass index (BMI), which is required for completing analysis of the data. The 1998 study-a collaborative effort of the National Cancer Institute, the Triana Area Medical Fund, and the College of Nursing at the University of Alabama at Huntsville-investigated possible effects of DDT and other compounds on the risk of breast cancer, predominantly among African-American women in the area of Triana, Alabama. The study was initiated as a result of medical findings showing high blood levels of DDT among the local population who had consumed fish from a tributary of the Tennessee River that had been polluted by the discharge over several decades of large quantities of pesticides from a DDT production plant. Women participating in the study had a mammogram, physical examination, breast examination, and blood draw, and completed a questionnaire on diet and lifestyle factors. In order to complete analysis of the data and determine whether there is an association between environmental exposure to DDT and related chemicals and breast cancer risk, additional information on BMI is required.
Previous studies have estabished pesticide exposure as a possible risk factor for childhood cancer. The Agricultural Health Study (AHS), a prospective cohort study of pesticide exposure among 51,000 pesticide applicators in North Carolina and Iowa, provides an opportunity to study childhood cancer incidence and mortality among the children of pesticide applicators. Name and dates of birth for 21,985 children were previously provided by adult participants in the AHS. The current study seeks to identify cases of cancer among these children through record linkage to state cancer and death registries. Cancer incidence and mortality within the cohort will be compared with national data through standardized incidence and mortality ratios. A limited case-cohort comparison of pesticide exposures will also be performed. Approximately 44 cases of childhood cancer are expected to be identified. No follow-up or contact with cases is anticipated. It is anticipated that the study results will provide insight into the relationship of pesticide and other farm exposures to the pathogenesis of childhood cancer.
Summers Laboratories has developed a non-pesticide treatment for head lice. Lice Asphyxiator (L.A.) works by mechanically blocking the respiratory spiracles of the head lice, therefore causing a quick-acting suffocation that will not result in the development of resistance. The objectives of this open label study are to evaluate the efficacy and safety of home use of two 10-minute treatments of 5% L.A. (applied one week apart).
This is a multi-center, randomized, double blind, vehicle controlled, study designed to evaluate the pediculicidal activity of Summers 5% L.A. compared to a vehicle control.
This project is designed to establish whether pesticides or other environmental agents have a role in the excess birth defects identified in the Red River Valley of Minnesota. In this human study, laboratory based health parameters will be used to key in health survey data. In vitro data will be developed to mechanistic information. Concordant results among these study features will provide a weight of evidence approach.
This is a community-based participatory research program focusing on pesticide contamination in migrant farmworker families.
This protocol describes an exposure assessment study of farmers in North Carolina and Iowa who personally apply the fungicides captan, thiophanate-methyl, and benomyl to apple and peach orchards. The exposure assessment will include environmental measurements as well as biological monitoring data. The biomonitoring data will be based on 24-hour urinary metabolites of the three fungicides selected for study. The study is being done in collaboration with the Argicultural Health Study (AHS), a large prospective health study of licensed private (farmer) and commercial applicators, and the spouses of private applicators. The AHS is sponsored by the National Cancer Institute, the National Institute of Environmental Health Sciences and the Environmental Protection Agency. The study described here will be conducted by the National Institute of Occupational Safety and Health. In summary, the objectives of this study are 1) to measure actual exposures to the target fungicides using both environmental and biological measures of exposure, 2) to identify and quantify major determinants of exposure, 3) to describe within- and between-worker exposure variability, and 4) to evaluate, to the extent possible, agreement between exposure estimates computed using the AHS exposure algorithms and exposure estimates based on actual measurements.
This project implements and evaluates a promotora-based intervention targeted at adolescent farm workers. The goal of the project is to determine the effectiveness of each intervention in promoting increased knowledge and practice of pesticide safety behaviors.
The goal of this project is to develop and test the effectiveness of a Lay Health Advisor program to teach migrant and seasonal farmworkers about pesticide safety in their homes. This is a community-based collaborative research project in which we first conduct in-depth interviews with farmworkers to learn about their knowledge and beliefs relative to pesticide exposure in the home, and, second, develop the content of the Lay Health Advisor program based on this formative information. We will evaluate this program by conducting pre- and post-test interviews with farmworkers, and comparing safety and knowledge to a control group who receive other important health education.
The "Agricultural Health Study" (AHS) is a collaborative effort between the National Cancer Institute and the National Institute of Environmental Health Sciences. The U.S. Environmental Protection Agency and the National Institute for Occupational Safety and Health are providing support for a limited exposure assessment effort. Initial data collection on a prospective cohort of 89,658 study subjects has been completed as of December 1997. Participants completed questionnaires that included items on pesticides used, other agricultural exposures, and work practices that modify exposure as well as on other activities that may affect either exposure or disease risks (e.g., diet, exercise, alcohol consumption, medical conditions, family history of cancer, other occupations and smoking history). Phase II of the study (1998-2003) updated information on occupational exposures, diet, work practices and medical history by means of a computer assisted telephone interview. We also collected buccal cells on sample of 34,000 study participants to assess the effect of inheritable polymorphisms and the interaction of environment and genomic predisposition. The stimulus for this prospective investigation comes from the growing evidence that, despite a low mortality overall, farmers experience an excess of several cancers. These excesses have been observed in retrospective epidemiological studies among agricultural workers in several countries. Excess cancers are observed for the lymphatic and hematopoietic system, connective tissue, skin, brain, prostate, stomach and lips. Several of these tumors (brain, NHL, multiple myeloma, and prostate) are also increasing in the general population in many of these countries. This suggests a common set of exposures may explain the high rates in farmers and rising rates in the general population. Farmers, their families, and other pest control workers may have contact with a variety of potentially hazardous substances including pesticides, solvents, fuels and oils, engine exhaust, dust and zoonotic viruses and other microbes. Our cohort study includes all registered pesticide applicators in Iowa and North Carolina and the spouse of applicators who are farmers. The health effects of pesticide use are the primary focus of the study. The influence of other farm exposures are also being evaluated. The focus of the phase II follow-up period (2004-2008) is to update exposure information and health histories by means of a computer assisted interview and also following the cohort to determine disease incidence and mortality. The cohort is being followed through the cancer registries within Iowa and North Carolina, the Social Security Administration database, state vital statistics offices, National Death Index, and various in-state databases, such as the listing of registered pesticide applicators. Individuals who enrolled into the study but who are no longer at the address given during enrollment (based on subsequent attempts at follow up) have been submitted and will continue to be submitted (through NIOSH) in the standard format to the IRS under their Project 057 Taxpayer Address Request Program. Identifying data provided to the IRS include only SSN and the first four letters of last name of cohort member. IRS provides in return the most current address in IRS records if a match (SSN + all four letter of last name) is found. The purpose of this effort is to identify members of the cohort who have moved out of state, to enable adjustment of person-years for incidence and mortality calculations. Persons who have moved out of state can be followed for vital status and cause of death, but not for cancer incidence. Continuation of the protocol will provide a valuable epidemiologic resource to help prevent cancers in the future by identifying risk factors in the rural/agricultural environment. Because more cases of important cancer outcomes occur in this cohort every year, potential cancer causes can be evaluated with increased statistical power. Larger number of cases also allows for statistical control of confounding factors, making more meaningful conclusions about cancer risk, and, for some relatively infrequent cancers, such as the lyphomas and leukemias, greater follow-up time is necessary to make any meaningful observations.
Background: The Agricultural Health Study (AHS) studied farmers and their spouses in North Carolina and Iowa. It also included people who worked with pesticides in Iowa. They answered a questionnaire and gave data about their children born since 1975. Researchers want to link this data to public data like birth and death certificates. They want to study how early life exposures to farms are linked to cancer and other bad health outcomes. Objective: To study data to find links between early life farm exposure and negative health outcomes. Eligibility: There will be no human subjects. Design: Researchers will get public data in the two study states. This will come from things like: Birth certificates Driver s licenses Voter registration Death certificates Based on these plus the AHS data, they will create a study group. It will be called Early Life Exposure in Agriculture (ELEA). Researchers will link ELEA data to cancer data. This will identify prevalence of cancer. They will study parents answers on the AHS. The topics include farm practices and pesticide use. They will determine ELEA exposure to pesticides. Researchers will analyze the cancer and pesticide results and look for links.
Primary objective is to determine the impact of messages related to conventionally grown and organically grown produce on purchasing behaviors in low-income individuals. Secondary objective is to assess knowledge and attitudes about conventionally and organically grown fruit and vegetable in low-income individuals.
This study will look for links between corn farming practices and short-term changes in immune function in farmers throughout the growing season. It will examine biologic effects associated with specific pesticide exposures and general planting activities, such as tillage. Farmers have an increased risk of non-Hodgkin s lymphoma and certain other blood cancers such as multiple myeloma and leukemia, but the reasons for this increase have not been identified. Findings of this study may contribute to learning the causes of cancers such as non-Hodgkin s lymphoma. Farmers enrolled in the Agricultural Health Study (a study of pesticide applicators and their spouses in Iowa and North Carolina) and a group of control subjects selected from agricultural extension workers in Iowa may participate in this study. The study involves six home visits to farmers and four visits to farmers to individuals in the control group. All participants will complete the following tests and procedures: * Questionnaires and diaries During the first visit, all participants will have a medical history review, including questions about smoking and other health habits. Farmers will be asked about their farming practices, and controls will be asked about their occupations. Farmers will fill out daily diaries during short time periods of interest around certain pesticide applications to describe farming activities that day. At other times during the growing season before harvest, farmers will fill out weekly diaries describing farming activities; controls, meanwhile, will fill out weekly diaries describing their health and work activities. At home visits during the farmers growing season, all participants will fill out questionnaires about their health. Finally, farmers and controls will complete a more extensive questionnaire in the off-season, during the last home visit, to learn about their activities and exposures in the final part of the year (post-harvest for farmers). * Urine samples: At the time of each home visit, controls will provide a urine sample that the interviewer will take that day. Farmers, too, will provide urine samples at the time of home visits, but they will also collect urine samples for a period of 4 days each during short time periods of interest after certain pesticide applications. The interviewer will collect these samples immediately at the end of these periods. * Blood samples: At the time of each home visit, the interviewer will draw 50 ml (3.5 tablespoons) of blood. * Telephone calls: Farmers will be called frequently from once every 2 weeks to every other day to schedule visits at the times of interest. Control subjects will also be called frequently to schedule their visits closely to those of the farmers.
Systemic lupus erythematosus (SLE) is severe, chronic, disabling autoimmune disease that significantly affects health status and quality of life. Since the disease occurs most often in young to middle-aged adults, SLE can also affect work and disability. However, there is currently little information on work-related disability from longitudinal, population-based studies of SLE. Participants were enrolled into the Carolina Lupus Study between February, 1997 and July 1999. We plan to conduct two telephone contacts with patients and one telephone contact with controls in a follow-up study to be conducted in 2001. The first patient contact will follow an introductory letter that describes the follow-up study. This letter provides participants the opportunity (via a toll-free phone number) to decline further contact about this study. The first patient contact will be a short (5 minute) interview in which we determine their current source of lupus-related medical care, timing of next expected visit, and update contact information. The second contact will involve a 60-minute telephone interview covering medical care utilization, current health status (including a patient-administered measure of lupus activity), work and disability issues, psychosocial attributes (e.g. helplessness, social support, daily stressors including race-related issues), and changes in exposures since the initial interview. We will attempt to schedule the patients' interviews within 3 months before or after the patient sees his or her own physician for SLE-related evaluation or treatment. A short (15 minutes or less) telephone interview will be conducted with controls focusing on current health, work status, and daily stresso. Ddisease damage will be assessed using the System Lupus international Collaborating Clinics (SLICC)/American College of Rheumatology (ACR) Damage Index, a standardized and validated instrument that is completed by the patient's physician. We will seek death certificates for patients and controls who have died in order to obtain cause of death information. Next-of-kin information from death certificates will not be used. This study will allow up to determine the feasibility of obtaining reliable data on disease damage from more than 50 physicians involved in the treatment of patients in the Carolina Lupus Study. This developmental work is a necessary foundation for any additional follow-up studies of the Carolina Lupus Study cohort. We will also be able to examine associations with disability in patients and in controls and to examine the contribution of various factors to the increased disease severity experience by African-American SLE patients.
The purpose of this project is to help families and communities identify and reduce health risks from lead, pesticides and, ultimately, other environmental hazards. We have partnered with the Better Housing League and Baby's Milk Fund in Cincinnati and nationally with the Alliance to End Childhood Lead Poisoning and the National Center for Lead Safe Housing. The first specific aim of this project is to evaluate a sampling kit for families to assess levels of lead and pesticides in their home environment. This aim will strengthen right-to-know laws by providing families with tools to assess environmental contamination in their own homes. The second aim is to increase community awareness of the role of environmental agents in developmental disorders, hearing loss and school problems.
This community-based project, called the Together for Agricultural Safety project, was developed to help farmworkers reduce their exposure to dangerous agricultural chemicals (such as pesticides) through education and social marketing. The project is a partnership of university researchers and the Farmworkers Association of Florida. After collecting extensive data from farmworkers, health providers and farm owners about primary means of pesticide exposure we are collaboratively developing an intervention that will reduce pesticide exposure by educating workers and owners about: the need to have adequate washing facilities; to wash hands frequently; to obey reentry intervals; to change work clothes after work to prevent child exposure and more.
Non-Hodgkin's lymphoma (NHL) is the third most rapidly increasing cancer in the United States. HIV-related NHL is responsible for some of the increase since the early 1980s. However, it cannot explain the steady increase in the incidence rates in earlier years, nor the entire increase shown recently. A possible role of environmental exposures is receiving attention. One possibility is that exposure to organochlorines (OCs) may be related to the occurrence of NHL. NCI is currently designing a large population-based case-control study to investigate this hypothesis further by analyzing OC levels in blood collected at the time of interview from cases of NHL and their matched controls. At the time of these interviews, cases in the main case-control study would most likely have already received chemotherapy. If chemotherapy changes the blood levels of OCs, this may lead to misclassification of exposure among cases and eventually to biased risk estimates. The purpose of this pilot study is to estimate the bias due to measuring the serum levels of OCs in cases during or after chemotherapy. Twenty newly diagnosed patients will be recruited for the study. From each patient, four consecutive blood samples, one prior to, two during, and one after chemotherapy, will be collected. Forty pairs of pre-existing cryopreserved serum samples (pre- and post-treatment) taken from the NHL patients who participated in an earlier NCI clinical study will also be included in this study. Samples will be assayed for OC levels. The results will be used to plan and to interpret another large case-control study (the main study).
The Heartland Study is a prospective, observational study that will enroll up to 2,600 pregnant participants across the Heartland States in the U.S.. The objective of the Heartland Study is to address major knowledge gaps concerning the health effects of herbicides on maternal and infant health. The study is being conducted to evaluate the associations between environmental exposures to herbicides during and after pregnancy and reproductive health outcomes. The study is measuring multiple biomarkers of herbicide exposure among pregnant Midwesterners and their partners to evaluate associations with pregnancy and childbirth outcomes, epigenetic biomarkers of exposure, and child development.