Durham County

Researchers are studying both adult- and childhood-onset myositis, an inflammatory muscle disease that can damage muscles and other organs, causing significant disability. The study aims to better understand the causes, immune system changes, and medical issues linked to myositis by evaluating children and adults with polymyositis, dermatomyositis, or related conditions. Healthy children and adults will also be included as control subjects for comparison. Participants will undergo a full medical history, physical exam, and review of medical records along with blood and urine tests. They may choose to participate in an additional evaluation lasting 1 to 5 days that can include muscle strength and joint movement tests, skin assessments, MRI scans of leg muscles, swallowing and speech studies, lung and heart function tests, endocrine and eye exams, nutrition assessments, muscle ultrasound, electromyography, and muscle or skin biopsies. Some patients may have a single evaluation, while others may return for follow-up visits up to one year. Throughout the study, participants will complete questionnaires and physical assessments to track their health and abilities. Healthy children will have similar tests including medical history, brief physical exams, swallowing and speech assessments, and muscle mass evaluation. The main outcome measure is a physicians global assessment at enrollment and during study visits. This observational study allows participants to contribute valuable information about myositis and related conditions over time.

This research aims to explore environmental factors linked to autoimmune diseases, focusing on myositis, a condition that weakens muscles and can cause other health issues. Researchers are particularly interested in the anti-synthetase syndrome, a subtype of myositis associated with specific autoantibodies and lung disease. The study investigates whether people with this syndrome have different environmental exposures before disease onset compared to other myositis patients and healthy volunteers. Participants will undergo a detailed medical history review and physical exam, provide blood, urine, and house dust samples, and complete questionnaires about exposures at work, home, and elsewhere. Those with myositis will be asked about infections, intense physical activity, sun exposure, tobacco and alcohol use, and stress before diagnosis. Healthy volunteers will answer similar questions matched to the diagnosis date of their paired myositis participant. Dust samples will be collected using a vacuum filter kit for potential future analysis. Additional clinical tests like lung function and imaging may be performed as needed. Throughout the study, participants will provide samples and complete questionnaires to capture medical history and environmental exposure details. Researchers will also collect clinical, laboratory, and immunologic data to assess disease manifestations and severity. Some participants may undergo chest x-rays, CT scans, pulmonary function tests, and biopsies if clinically indicated. Blood and dust samples will be stored for current and future studies. The study involves participants aged 2 to 100 years, including healthy volunteers without autoimmune diseases.

This research aims to evaluate the effects of the study drug hymecromone in adults with interstitial lung disease or lung fibrosis, conditions that cause thickening and scarring of lung tissue, often worsening over time and leading to serious outcomes. The study is a Phase 2a open-label trial enrolling up to 37 participants with progressive interstitial lung disease. The main goal is to assess how hymecromone influences serum hyaluronan levels and other related biomarkers. Participants will take hymecromone tablets, 400 mg twice daily 2 tablets in the morning and 2 at night, for 12 weeks. Those who wish may continue for an optional 12-week extension, making the maximum treatment period 24 weeks. The study includes at least seven clinic visits over five months, with repeated testing during the treatment and extension phases. During the study, participants will undergo various assessments including blood tests, heart function tests, sputum collection, spirometry to measure lung capacity, diffusion capacity tests for oxygen transfer, resting energy expenditure measurement, and a 6-minute walk test to evaluate physical function. Researchers will monitor safety, tolerability, lung function, symptoms, and biomarker changes throughout the study. The total participation duration is about five months, including the optional extension for some.

Researchers are investigating how certain white blood cells, such as neutrophils and monocytes, respond to signals in the body and what substances they produce. This study focuses on understanding how these cells might contribute to inflammation and measures substances in blood plasma that could stimulate white blood cells. The research particularly looks at signaling pathways activated by lipopolysaccharide LPS and other immune stimuli in human leukocytes in laboratory tests. Healthy adult volunteers aged 18 to 65 donate up to 320 milliliters of blood no more than once every 8 weeks, with a maximum of six donations per year. The collected blood is separated into its components, and immune cells are exposed to inflammatory substances in the lab to observe their responses, including chemical signaling and functional activities. The study also examines the role of cholesterol-rich areas in cell membranes, the tumor suppressor gene p53s influence on inflammation, and zinc finger proteins effects on gene expression in inflammatory cells. Participants undergo blood donation in a monitored setting, and their blood samples are tested for HIV and hepatitis BC every 6 months to ensure safety. Researchers analyze various immune cell responses to inflammatory stimuli, including gene expression and signaling pathways. The study aims to better understand inflammation mechanisms by measuring these responses in vitro. Participation involves multiple blood donations over time, with careful blood screening and monitoring of donor health throughout the study.

Researchers are investigating the genetic basis of inherited reproductive system disorders, focusing especially on conditions related to puberty and hormone regulation. The study aims to better understand idiopathic hypogonadotropic hypogonadism IHH, a rare disorder caused by deficient secretion of gonadotropin-releasing hormone GnRH, which affects sexual development and fertility. This observational study explores a range of related disorders, including early puberty, delayed or absent puberty, and later-life hormonal issues, to uncover how these conditions may be inherited. Participants in this study will provide blood samples for genetic testing and complete questionnaires about their symptoms. They will also undergo a scratch-and-sniff test to assess any issues with their sense of smell. Researchers will review participants medical records and collect detailed family medical histories. Family members of participants, whether affected or unaffected by these conditions, are encouraged to join. No treatments are provided as part of the study. Throughout the study, participants genetic data will be analyzed alongside clinical and biochemical information to identify known and novel genetic variants associated with reproductive disorders. Researchers will look for connections between these genetic findings and the participants health characteristics. The main goal is to deepen understanding of GnRH regulation and its impact on puberty and fertility. Participation involves blood sample collection, questionnaires, and medical record review, with no active intervention. The study is ongoing and exploratory in nature.

Researchers are investigating whether overweight girls enter puberty earlier than girls of normal weight. The study focuses on pre-menarchal girls aged 8 to 14 years who have some breast development but have not started their first period. The aim is to better understand pubertal development by using advanced methods like breast ultrasound to distinguish breast tissue from fatty tissue, as well as detailed reproductive assessments. Participants are divided into two groups based on weight normal weight and overweight. The study involves one or more visits within a 4-week period, during which girls undergo a physical exam including breast and genital examination, breast and pelvic ultrasounds, blood and urine tests, a DXA scan to measure body fat, and a hand X-ray to assess bone maturity. Some participants may be asked to return six months later for repeat testing to monitor changes over time. During the study, researchers will collect various measurements such as breast maturation scores from ultrasound and Tanner breast staging, reproductive hormone levels, body composition, and bone age. These assessments help determine the timing and progression of puberty. The primary outcome is to correlate breast ultrasound findings with clinical breast staging. The total study duration extends up to September 2026, with follow-up assessments occurring semiannually for some participants.

Researchers are exploring how environmental factors like pollution, diet, and stress contribute to human diseases and inflammation. The study aims to understand how these exposures cause injury and affect disease development by examining interactions between individuals and their environment. This observational study focuses on healthy adults aged 18 to 90 years and seeks to develop improved methods for measuring these host-environment interactions. Participants in this study may provide a variety of biological and environmental samples, including blood, hair, stool, saliva, urine, skin cells, nail clippings, exhaled breath, sputum, nasal cells, cheek cells, and sperm samples if applicable. Some participants may undergo procedures like bronchoscopy or pelvictransvaginal ultrasound and perform lung function tests. Samples of household dust, urine, or stool may also be collected at home. Participants will complete surveys about their health, diet, and environmental exposures. During the study, participants will be screened using health history questions and demographic information. The study may involve one or more visits, during which samples and data are collected. Researchers will analyze biological markers related to cell injury and inflammation, such as inflammatory cytokines and DNARNA damage, to better understand environmental impacts on health. Participants may be contacted later for involvement in other studies, with the total participation time varying by individual.

Researchers are conducting a long-term observational study to better understand how environmental factors and bacteria impact moderate to severe atopic asthma in adults aged 18 to 60. The study aims to explore the natural history of asthma by collecting samples and data over time, focusing on how environmental exposures relate to asthma symptoms, disease progression, and response to therapy. About 200 participants will be enrolled in this exploratory single-center study. Participants will provide various samples including blood, urine, DNA, saliva, sputum, stool, and household dust. Some may also participate in an optional bronchoscopy visit involving airway examination and cell sample collection. The study includes regular visits every six months for five years, with additional sick visits available as needed. During visits, participants will undergo medical history reviews, physical exams, lung function tests, and surveys about asthma symptoms and quality of life. Throughout the study, participants will have asthma check-ups and receive standard asthma care at no cost. Samples and questionnaires collected will help researchers study microbiological and genetic influences on asthma. Some participants will use home devices for additional data collection. The study will monitor participants for up to five years, supporting future asthma research and possible study expansion.

Researchers aim to build a repository of biological samples from healthy adults to help develop and improve laboratory tests and sample handling procedures. This observational study focuses on people aged 18 and older who are healthy and willing to donate samples for research use. The collected samples will support various studies, including quality control and exposure variability assessments. Participants will attend one study visit lasting up to two hours, during which they will provide blood and urine samples. Blood will be drawn from a vein, with up to 4.5 tablespoons collected, and urine will be collected using a sterile container. Some participants may provide other types of samples or additional samples if initial ones are used up. During the visit, participants will be screened through health history questions and medication lists. They will consent to donate samples for current and future research. Researchers will monitor sample quality and storage, and approved investigators will access the repository for laboratory assay development and testing. The total participation involves a single visit with no ongoing treatment or follow-up.

Researchers are investigating how environmental factors like pollution, chemical exposure, foods, medicines, and sleep habits may affect the endocrine and reproductive systems. The study focuses on individuals with hormone-related conditions such as hypogonadism, infertility, and other reproductive disorders. It aims to explore the possible links between internal and external environmental exposures and reproductive and endocrine dysfunction over time. Participants include males and females aged 8 years and older with various reproductive endocrine disorders, including polycystic ovary syndrome, hypogonadism, delayed or precocious puberty, and other related conditions. Children may participate until age 23, with up to 12 visits over five years, while adults may have 4 to 5 visits during the same period. During visits, participants undergo physical exams, blood and urine tests, questionnaires about diet and health, and sometimes additional tests like imaging scans or semen analysis. Throughout the study, researchers will collect data on body composition, resting energy expenditure, nutrition, stress, and psychological factors related to reproductive health. Most visits last less than three hours. The main goal is to assess how environment and lifestyle relate to reproductive neuroendocrinology at baseline and after clinical care. The study includes ongoing monitoring and data collection to better understand reproductive and endocrine health over time.