Durham County

Researchers are investigating adult- and childhood-onset myositis, an inflammatory muscle disease that can cause muscle damage and affect other organs, leading to significant disability. This study aims to better understand the causes, immune system changes, and related medical problems in people with polymyositis, dermatomyositis, or related conditions. Both affected children and adults, as well as healthy individuals, will be enrolled to compare test results and learn more about this condition. Participants diagnosed with myositis or related disorders will undergo a thorough medical history review, physical examination, and blood and urine tests. They may also choose to take part in an additional evaluation lasting from 1 to 5 days, which can include muscle strength testing, skin assessments, magnetic resonance imaging of leg muscles, swallowing studies, voice and speech assessments, lung and heart function tests, endocrine evaluations, eye exams, nutrition assessments, muscle ultrasound, electromyography, and biopsies of muscle or skin. Healthy children will also participate in medical history, physical exams, blood and urine tests, speech and swallowing studies, ultrasound studies, and bioelectric impedance testing; children aged 8 to 18 may have exercise testing as well. Participants may be evaluated once or return for a follow-up assessment within one year. Throughout the study, physicians will assess participants using the Physician Global Assessment Form at enrollment and during each visit. The study involves questionnaires, physical tests, imaging, and laboratory studies to monitor disease status, muscle function, and related health factors. Safety and ability to participate are also monitored, with some procedures excluded in pregnant women due to radiation or biopsy risks.

Researchers are investigating the role of environmental factors in triggering the anti-synthetase syndrome, a form of myositis that includes muscle weakness and lung disease, in genetically susceptible individuals. This syndrome is linked to autoantibodies targeting synthetases, proteins involved in making new proteins, and tends to present with symptoms such as fever, arthritis, and elevated white blood cells. The study compares environmental exposures in patients with recent-onset anti-synthetase syndrome to those in myositis patients without the syndrome and healthy volunteers to identify differences that may contribute to disease development. Participants include individuals diagnosed with myositis within the past 24 months, with or without anti-synthetase syndrome, and matched healthy controls without autoimmune diseases. All participants undergo medical history review, physical exams, and provide blood, urine, and house dust samples. They complete questionnaires about exposures such as infections, heavy exercise, sun exposure, tobacco and alcohol use, and stressful events prior to diagnosis. A dust collection kit is provided to collect bedroom dust for future analysis. Clinical tests like lung function testing, imaging, and biopsies may be performed on myositis patients as clinically needed. During the study, researchers collect detailed clinical, laboratory, and immunological data to document disease status and severity. Imaging tests including chest X-rays and high-resolution computed tomography scans, pulmonary function tests, bronchoalveolar lavage, and biopsies may be done based on clinical indications. Samples of blood, tissue, and environmental dust are stored for current and future research. The main goal is to determine if infectious and noninfectious environmental exposures are more common before disease onset in patients with anti-synthetase syndrome compared to controls and other myositis patients.

Researchers are investigating the effects of a drug called hymecromone (H01) in adults with progressive interstitial lung disease (ILD), including idiopathic pulmonary fibrosis. ILD affects lung tissue involved in oxygen and carbon dioxide exchange and can lead to fibrosis, which worsens over time and often results in death within 3 to 5 years. This phase 2a, open-label study aims to evaluate the safety, tolerability, and effectiveness of H01 in reducing serum hyaluronan levels, a biomarker related to fibrosis, over a 12-week period. Participants will take 400 mg of hymecromone orally, consisting of 2 tablets in the morning and 2 tablets at night for 12 weeks. The study involves multiple visits over approximately 5 months, including screening, baseline, and follow-up visits. Various clinical tests will be conducted, such as spirometry to measure lung function, diffusion capacity tests for oxygen transfer, resting energy expenditure, and a 6-minute walk test to assess exercise capacity. Echocardiography and blood tests will also be performed to monitor heart function and biomarker changes. During the study, participants will undergo regular assessments including blood draws, sputum samples, lung function tests, questionnaires about respiratory symptoms, and heart ultrasounds. Researchers will monitor changes in lung function, walking ability, biomarker levels, and safety throughout the treatment period. The total duration of participation is about 5 months, with at least 7 clinic visits for comprehensive evaluation and monitoring.

Researchers are studying how human white blood cells, including neutrophils, monocytes, eosinophils, and lymphocytes, respond to various signals in laboratory tests. The goal is to understand how these cells detect signals, produce substances, and sometimes contribute to inflammation. The study also looks at substances in blood plasma that may stimulate these immune cells, helping to clarify how blood reacts to conditions related to disease. Specific areas of investigation include the role of lipid rafts in cell signaling, the impact of the tumor suppressor gene p53 on inflammation regulation, and the effect of zinc-finger proteins on gene expression in immune cells. Healthy adult volunteers aged 18 to 65 who weigh at least 110 pounds will donate up to 320 milliliters of blood at each visit, with donations spaced at least 8 weeks apart and limited to six times per year. Blood samples will be separated into components, and immune cells will be exposed to inflammatory stimuli such as lipopolysaccharide (LPS) in laboratory conditions. Researchers will measure various signaling pathways and functional outcomes like chemotaxis and cytokine production, with some experiments involving chemical inhibitors. The study also examines how genetic factors and cholesterol-rich membrane areas influence immune cell responses. Participants undergo screening to ensure they are healthy and free from certain infections or conditions. Blood samples will be used for detailed laboratory analyses of immune cell behavior and signaling. The study monitors various measures related to inflammation and immune response, with careful attention to safety and participant health. Blood donations and visits are carefully scheduled, and results contribute to understanding immune system functioning and inflammatory processes in humans.

Researchers are investigating inherited reproductive disorders involving abnormal puberty timing or hormone levels. The study focuses on idiopathic hypogonadotropic hypogonadism (IHH), a rare condition caused by low secretion of gonadotropin-releasing hormone (GnRH), leading to delayed, incomplete, or absent puberty. Since many patients with IHH do not have known genetic mutations, this research aims to identify new genetic factors and better understand the biology of puberty and reproductive function. Participants include individuals with early puberty, delayed or absent puberty with low hormone levels, normal puberty followed by hormone abnormalities, or features suggesting risk for hypogonadotropic hypogonadism. Participants provide a blood sample for genetic testing, complete symptom questionnaires, and take a scratch-and-sniff test to assess smell function. Medical records and family histories are reviewed, and family members may also join. This study does not provide treatment. During the study, researchers collect and analyze genetic data to identify known and novel variants related to reproductive disorders. They review medical and family histories and perform clinical assessments including smell testing. The main outcome is to discover genetic variants across the full range of idiopathic hypogonadotropic hypogonadism cases, improving understanding of puberty regulation and potential future therapies. Participants' involvement includes blood draws, questionnaires, and clinical evaluations without treatment, contributing to genetic and physiological research on reproductive disorders.

Researchers are investigating how obesity affects the timing of puberty in girls, focusing on breast development. They aim to determine if overweight girls start puberty earlier than normal weight girls. The study uses advanced methods like breast ultrasound to better distinguish breast tissue from fatty tissue, improving the accuracy of puberty assessment in overweight girls. Participants include healthy girls aged 8 to 14 years who are either normal weight or overweight, have some breast development, and have not started their first menstrual period. The study involves one visit, with the option for multiple visits within four weeks. During visits, 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. Parents may be contacted by phone for initial screening. Assessments occur at the visit(s) and may be repeated six months later. Researchers will measure pubertal development using breast ultrasound and Tanner breast staging, along with bone age and body composition. These evaluations help understand the relationship between obesity and early puberty while ensuring participant safety and comfort throughout the study.

Researchers are investigating how environmental factors like pollution, diet, and stress contribute to injury, inflammation, and the development or worsening of human diseases. The study aims to better understand these mechanisms by examining biological and environmental samples from healthy adults aged 18 to 90. The goal is to improve knowledge of how these exposures interact with the body and to develop better methods to measure these interactions. Participants may provide various samples including blood, hair, stool, saliva, urine, skin cells, nail clippings, exhaled breath, sputum, nasal cells, cheek cells, and sperm if applicable. Some may undergo procedures such as skin punch biopsies, bronchoscopy to collect lung fluid, pelvic or transvaginal ultrasounds, and lung function tests. They may also collect household dust and complete surveys about their health, diet, and environmental exposures. During one or more study visits, participants will be screened with questions about their health, demographics, and medications. Researchers will analyze collected samples for markers of cell injury and inflammation and track biological responses to environmental factors. Participants may be contacted for future studies. The study monitors biological markers such as inflammatory cytokines and DNA/RNA damage to understand disease development related to environmental exposures.

Researchers are studying moderate to severe atopic asthma to understand how environmental factors and bacteria influence asthma symptoms and disease progression over time. This observational study will collect data and samples from adults aged 18 to 60 with persistent asthma, aiming to explore the microbiological and genetic factors involved. The study will also generate hypotheses for future research by examining the interaction between environmental exposures and asthma outcomes. Participants will provide various biological samples including blood, urine, saliva, sputum, stool, and household dust. Some may also undergo a bronchoscopy, a procedure involving a flexible tube inserted into the airways for detailed lung examination and cell sampling. Visits occur every six months over five years, with additional sick visits as needed, all including medical exams, lung tests, and asthma treatment at no cost to the participant. During the study, participants will complete medical history forms, physical exams, breathing tests, and surveys about their asthma symptoms and quality of life. Samples collected will be analyzed alongside environmental exposure data to understand asthma control and treatment response. The study includes safety monitoring, and participants can remain in the study even if pregnant, though some procedures like bronchoscopy may be restricted during pregnancy. Overall participation lasts five years, with the potential for study expansion.

Researchers are building a collection of biological samples like blood and urine from healthy adults aged 18 and older. This collection will support research to develop and test laboratory tests, maintain quality control in sample handling and storage, and study how exposure to various factors changes over time. The study involves healthy people to help improve medical testing methods and sample management. Participants will visit the study center once for a session lasting up to 2 hours. During this visit, they will provide blood samples—up to 4.5 tablespoons drawn from a vein—and a urine sample in a sterile container. Some participants might be asked to provide additional types of samples or to give new samples if the originals run out. During the visit, participants will answer health history questions and list any medications they take. Researchers will monitor and store the samples carefully to ensure quality. The main goal is to create a well-maintained repository accessible to approved investigators for future research and quality control testing.

Researchers are studying how environmental and lifestyle factors affect the endocrine and reproductive systems, particularly in people with reproductive disorders such as hypogonadism and infertility. The study explores how hormone disorders caused by gland problems might relate to exposures like pollution, chemicals, foods, medicines, and sleep habits. It aims to understand how these external and internal factors influence reproductive and endocrine health and how clinical treatment may change these effects over time. Participants include males and females aged 8 years and older with diagnoses related to reproductive dysfunction. Adults are expected to attend 4 to 5 study visits over 5 years, while children could have up to 12 visits and remain in the study until they turn 23. Each visit typically lasts less than 3 hours. During the study, participants will undergo physical exams, blood and urine tests, complete questionnaires about diet and health, and possibly additional tests like imaging scans and semen analysis. Some specialized tests include body composition measurements using air displacement and resting energy expenditure tests to assess calorie burn. Throughout the study, participants will provide repeated biological samples and answer detailed questions about their health and environment. Researchers will monitor reproductive and endocrine function at baseline and after care for their conditions. The study does not have fixed endpoints but seeks to generate new understanding and hypotheses about how environmental factors impact reproductive and endocrine disorders. Safety and ability to participate will be monitored, with follow-up visits scheduled according to individual needs.