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Detection and Characterization of Host Defense Defects

Immune Defects

This protocol is designed to evaluate selected patients with documented recurrent or unusual infections and their family members for clinical and laboratory correlates of immune abnormalities. It allows long term follow up of patients with host defense defects and permits the periodic study of their blood, urine, saliva, skin, stool and vaginal specimens or wound drainage from such patients or their family members for medically indicated purposes and research studies related to understanding the genetic and biochemical bases of these diseases. This protocol may help provide patients and materials for the development of therapies for these diseases. This study will: 1. Determine the biochemical and genetic causes of inherited immune diseases affecting phagocytes (white blood cells that defend against bacterial and fungal infections) 2. Try to develop better ways to diagnose and treat patients with these diseases, and to prevent, diagnose and treat their infections Patients and family members may undergo the following procedures: * A personal and family medical history, physical examination and other procedures, which may include various blood tests; urinalysis; saliva collection; imaging studies such as chest X-ray, computed tomography (CT) or magnetic resonance imaging (MRI); and lung function studies, dental examination or eye examinations, if medically indicated. * Patients who have draining wounds will have fluid collected from these wounds for biochemical study. * Tissues removed as part of medical care, such as pieces of lung, liver, or teeth, or biopsies of these tissues will be studied. * Patients who have an immune problem that investigators wish to study further will be asked to return to NIH for follow-up visits at irregular intervals, but at least every 6 months. The visits will include an updated medical history, examination directed at the particular medical problem related to the immune disorder, follow-up of abnormal tests or treatment, and collection of blood, saliva, urine, or wound fluid for study. * Patients may have genetic testing and must be willing to have specimens stored for future research. * Family members will have a medical history, saliva or urine collection, and chest X-ray or other imaging study, if medically indicated. * Normal volunteers who have had tissue biopsies or pieces of tissue removed as part of medical care, such as pieces of lung, liver, or teeth, will have these tissues studied. * NIH does not cover the cost of the initial screening visit for travel or lodging. A financial assessment may determine if the patient is eligible for financial assistance. This study does not enroll children under the age of 2. * Patients will be asked to obtain their medical records, previous test results, or imaging studies prior to the first visit.

Начало: 01.09.1993 Възраст: 1–100 г.

United States National Institute of Allergy and Infectious Diseases ( NCT00001355

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Fungal Infection Susceptibility

Cryptococcal Infection Cryptococcal Pneumonia Pulmonary Cryptococcosis Cryptococcal Meningitis +1

The protocol will be carried out in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Good Clinical Practice (GCP) and the following United States Code of Federal Regulations (CFR) applicable to clinical studies: 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812. NIH-funded investigators and study site staff who are responsible for the conduct, management, or oversight of NIH-funded studies have completed Human Subjects Protection and ICH GCP Training. The protocol, informed consent form(s), recruitment materials, and all participant materials will be submitted to the Institutional Review Board (IRB) for review and approval. Approval of both the protocol and the consent form must be obtained before any participant is enrolled. Any amendment to the protocol will require review and approval by the IRB before the changes are implemented to the study. In addition, all changes to the consent form will be approved by the IRB; an IRB determination will be made regarding whether a new consent needs to be obtained from participants who provided consent, using a previously approved consent form. ...

Начало: 01.04.1993 Възраст: 18–99 г.

United States National Institute of Allergy and Infectious Diseases ( NCT00001352

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Studies of the Pathogenesis of HIV Infection in Human Peripheral Blood Cells and/or Body Fluids in People Living With and Without HIV

HIV Immunodeficiencies Infectious Diseases

We are studying virologic and/or immunologic parameters of HIV infection and other infectious or non-infectious immune deficiency diseases in order to better understand the pathogenesis of HIV. Because of the lack of an adequate animal model it is generally necessary to utilize human peripheral blood cells for studying aspects of either in vivo or in vitro HIV infection. We wish to be able to continue to elucidate many pathogenic aspects of HIV infection in relation to other infectious or non-infectious immune regulation and dysregulation using human peripheral blood mononuclear cells as a model.

Начало: 09.03.1993 Възраст: 18–120 г.

United States National Institute of Allergy and Infectious Diseases ( NCT00001281

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Magnetic Resonance Imaging (MRI) to Evaluate Activity of Multiple Sclerosis (MS)

Multiple Sclerosis

Studies performed under 89-N-0045 are designed to examine the natural history of multiple sclerosis (MS) using MRI and immunological measures. In addition to studying the natural history of untreated patients, the natural history of patients receiving approved disease-modifying therapies of MS will be examined. In both cohorts of patients levels of disease activity on MRI will be compared with immunological characteristics in order to help identify disease mechanism. Patients with either definite MS (based either on clinical or combined clinical and MRI criteria) or with an initial presentation of neurological dysfunction consistent with MS will be studied longitudinally by MRI. Disease activity on MRI will be assessed using several MRI measures of disease activity including the number of contrast enhancing lesions, the overall burden of disease, brain atrophy and measures to assess axonal damage. Patients will be assessed clinically and correlations between immunological and genetic factors and disease activity as seen clinically or by MRI will be studied. A second cohort of patients starting the use of approved therapy will also be examined. Patients referred to NIH prior to beginning approved therapy will be assessed with a series of three monthly MRIs to determine the level of pretreatment disease activity. After beginning approved therapy under the direction of their private physician, patients will be followed similarly to the natural history cohort. Immunological and genetic findings will be accessed before and during therapy in order to help establish the mechanisms of action of the therapies and to identify mechanisms accounting for either a response or lack of response to therapy. Part of the collected samples willl be cryopreserved to provide respository for further studies focusing on detection of biomarkers indicative of disease state, disease stage or repsonse to therapies. Additionally, a cohort of normal volunteers will be studied. The studies in the normal volunteers will be used to establish the most appropriate imaging sequences for studying normal white matter in MS patients using magnetization transfer (MT) imaging sequences for studying normal white matter in MS patients using magnetization transfer (MT) imaging and to provide normative immunological measures.

Начало: 23.07.1992 Възраст: 18–120 г.

United States National Institute of Neurological Disorders and Stroke NCT00001248

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Immune System Related Kidney Disease

Kidney Disease Nephrotic Syndrome

Kidney diseases related to the immune system include, nephrotic syndrome, glomerulonephritis, membranous nephropathy, lupus nephritis, and nephritis associated with connective tissue disorders. This study will allow researchers to admit and follow patients suffering from autoimmune diseases of the kidney. It will attempt to provide information about the causes and specific abnormalities associated with autoimmune kidney disease. Patients with kidney disease as a result of their immune system, and patients with diseases of the immune system who may later develop kidney disease, will be potential subjects for this study. Patients will undergo a history and physical examination, and standard laboratory test to more closely understand the causes, signs, symptoms, and responses to medication of these diseases. Based on these evaluations the patients may qualify as candidates for other experimental studies. At any time these patients may be asked to submit blood or urine samples for further research....

Начало: 25.06.1992 Възраст: 10–99 г.

United States National Institute of Diabetes and Digestive and Kidney NCT00001979

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Immune Regulation in Patients With Common Variable Immunodeficiency and Related Inborn Errors of Immunity (IEI)

XLA CVID Yao Syndrome Blau Syndrome

This study aims to understand the causes and progression of Common Variable Immunodeficiency (CVID) and related inborn errors of immunity (IEI). These are conditions where the immune system does not function properly, leading to frequent infections and other complications such as gastrointestinal inflammation, lung and liver disease, autoimmune conditions, and an increased risk of certain cancers. By studying patients with CVI and related immune disorders, we hope to develop better ways to diagnose, treat, and prevent complications associated with these conditions. Patients diagnosed with CVID or related immune disorders must be referred by their physician and medical records reviewed by the study team to confirm eligibility to participate in this study. Once enrolled, participants will undergo various tests, including blood draws, physical exams, and imaging studies like CT scans to track changes over time. We may collect samples such as blood, urine, stool, or saliva for research purposes. If a surgical procedure or biopsy is performed because it is medically necessary, we may collect an additional sample for research testing. Family members of patients may be asked to provide blood samples for comparison. Some tests may be done remotely if participants or family members cannot travel to the study site. Who Can Participate * Patients diagnosed with CVI or related IEI, such as X-linked agammaglobulinemia, Blau Syndrome or Yao Syndrome. * Participants must be at least 2 years old. * Family members of patients may include parents, siblings, grandparents, children, aunts, uncles, and cousins. * Pregnant women already enrolled in the study will continue to participate, but new pregnant participants will not be enrolled. Potential Risks and Benefits * Risks: Blood draws may cause discomfort, bruising, or infection. Apheresis may cause dizziness, nausea, or muscle cramps; this procedure is to collect specific cells in the blood and is infrequently done on this protocol. Extra biopsies during clinically indicated procedures may increase the risk of complications; they will only be collected after the medically necessary biopsies are taken and if it is safe to collect any extra biopsies. * Benefits: Participants may not receive direct medical benefits, but the study will contribute to a better understanding of CVID and related conditions, potentially leading to improved treatments.

Начало: 15.01.1990 Възраст: 2–120 г.

United States National Institute of Allergy and Infectious Diseases ( NCT00001244

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Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies

Healthy Volunteers HIV

This study will collect blood plasma and white blood cells from individuals using a procedure called apheresis. Apheresis is a method of collecting larger quantities of certain blood components that can safely be collected through a simple blood draw. The blood components will be used in laboratory research studies. Patients 18 years of age and older who are currently enrolled in a NIH clinical research protocol may participate in this study. Relatives of patients and normal healthy volunteers will also be enrolled. Individuals will undergo one of the following two apheresis procedures: * Automated pheresis Blood is drawn through a needle placed in an arm vein and circulated through a cell separator machine. The plasma (liquid part of the blood) and white cells are extracted, and the red cells are re-infused into the donor through the same needle or a needle in the other arm. An anticoagulant (medication to prevent blood from clotting) is usually added to the blood while in the machine to prevent it from clotting during processing. * Manual pheresis One unit (1 pint) of blood is drawn through a needle placed in an arm vein, similar to donating a pint of whole blood. The red blood cells, with or without plasma, are separated from the rest of the blood and returned to the donor through the same needle. Manual pheresis will be done only when a person s estimated total blood volume or red cell count is too low to safely permit removal of blood through a pheresis machine. An adult small in size or markedly anemic, for example, may fall into this category. Some of the blood collected through apheresis may be stored for future studies of HIV disease and immune function and for HLA testing, a genetic test of markers of the immune system. Some of the blood may be used to screen for different types of viral liver infections, such as hepatitis A, B, C, D, E, F, or G.

Начало: 09.01.1984 Възраст: 18–100 г.

United States National Institute of Allergy and Infectious Diseases ( NCT00114647

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Use of Cysteamine in the Treatment of Cystinosis

Cystinosis

Cystinosis is an inherited disease resulting in poor growth and kidney failure. There is no known cure for cystinosis, although kidney transplantation may help the renal failure and prolong survival. Both the kidney damage and growth failure are thought to be due to the accumulation of the amino acid cystine within the cells of the body. The cystine storage later damages other organs besides the kidneys, including the thyroid gland, pancreas, eyes, and muscle. The drug cysteamine (Cystagon; ProCysBi) is an oral medication given to patients with cystinosis prior to kidney transplantation. The drug works by reducing the level of cystine in the white blood cells and muscle tissue. The drug may also decrease levels of cystine in the kidneys and other tissues. This study has several goals: 1. Long-term surveillance of cysteamine treated patients. 2. Detection of new non-kidney complications of cystinosis. 3. Maintenance of a patient population for genetic testing (mutational analysis) of the cystinosis gene.\

Начало: 04.01.1979 Възраст: 1–115 г.

United States National Human Genome Research Institute (NHGRI) NCT00359684

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Diagnosis and Management of Inflammatory and Infectious Diseases

Infection Inflammation

This protocol is being established to cover the evaluation of patients with inflammatory and/or infectious diseases which are not covered under previously existing protocols. The purpose of such a protocol is that frequently patients are referred to us with either diagnosed or undiagnosed illnesses which would be of interest to our teaching program or which would serve as a source of patients to subsequently be entered into established, ongoing protocol studies. Such patients will be admitted to the protocol and handled according to accepted medical practice of diagnosis and treatment.

Начало: 17.02.1978 Възраст: 3–100 г.

United States National Institute of Allergy and Infectious Diseases ( NCT00557726

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Studies on Tumors of the Thyroid

Hurthle Cell Thyroid Cancer Tall Cell Variant Thyroid Cancer Follicular Thyroid Cancer Thyroid Cancer +1

Participants in this study will be patients diagnosed with or suspected to have a thyroid nodule or thyroid cancer. The main purpose of this study is to further understand the methods for the diagnosis and treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the context of standard medical care that is offered to all patients with thyroid nodules or thyroid cancer. Other tests are performed for research purposes. In addition, blood and tissue samples will be taken for research and genetic studies.

Начало: 01.06.1977 Възраст: 6–98 г.

United States National Institute of Diabetes and Digestive and Kidney NCT00001160

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Natural History of Thyroid Function Disorders

Hyperthyroidism Hypothyroidism Grave's Disease

Participants in this study will be patients diagnosed with or suspected to have a thyroid function disorder. These conditions may include: hypothyroidism, hyperthyroidism, thyroid hormone resistance, Graves' Dermopathy, and thyroid-stimulating hormone (TSH) secreting pituitary adenomas. The main purpose of this study is to further understand the natural history, clinical presentation, and genetics of thyroid function disorders. Many of the tests performed are in the context of standard medical care that is offered to all patients with thyroid function disorders. In addition, blood and tissue samples may be taken for research and genetic studies.

Начало: 01.02.1977 Възраст: 6–98 г.

United States National Institute of Diabetes and Digestive and Kidney NCT00001159

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Genetic Studies of Insulin and Diabetes

Diabetes Mellitus Severe Insulin Resistance

The study will allow researchers to obtain blood, plasma, DNA, and RNA for genetic studies of insulin. There will be a focus on the causes of insulin resistance and diabetes mellitus. Insulin is a hormone found in the body that controls the level of sugar in the blood. Insulin resistance refers to conditions like diabetes when insulin does not work properly. In this study researchers would like to compare patients with diabetes and other forms of insulin resistance to normal individuals. The study will investigate how insulin attaches to cells. Researchers will take 4 to 6 ounces (100-150 ml) of blood from adult patients and may request up to 12 ounces (one unit) of blood if necessary. Skin samples may be taken for a biopsy if further genetic testing is necessary. In addition some patients may be asked not to eat for up to 72 hours prior to testing.

Начало: 01.02.1976 Възраст: 6–120 г.

United States National Institute of Diabetes and Digestive and Kidney NCT00001987

Предстои набиране

PAP Systems External Clinical Studies (ECS)

Obstructive Sleep Apnea

This is a pre-market study for ongoing product development aiming to explore the usability and performance of the study PAP systems.

Начало: 01.08.2028 Край: 29.10.2028 Възраст: 18–130 г.

ResMed NCT06562205

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Integrated Care Versus Usual Care for Opioid Use Disorder and Infectious Diseases in Veterans

Opioid Use Disorder HIV Hepatitis C Virus Gonorrhea +5

Opioid use disorder (OUD) confers a higher risk of acquiring and transmitting infectious diseases, which may have long-term health consequences in Veterans. Treatment of OUD with medication assisted therapy is highly effective, however this often occurs independently of infectious diseases care. This project will test out a new model that combines infectious diseases and OUD care within one VA clinic appointment. This new care model may improve the health of Veterans and reduce cost and time required for Veterans who often need to attend multiple outpatient appointments.

Начало: 03.04.2028 Край: 29.06.2029 Възраст: от 18 г.

United States VA Office of Research and Development NCT06766331

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Patients Gender Influence on Communication of Anaesthesia Risk

Anaesthesia Complication

In Anaesthesia Practice, an Informed consent involves discussing the risks and benefits involved with a certain procedure and its alternatives. Though it is intended to promote patient autonomy and enhance decision-making, the risk profiling, detailing and discussing; generally walks one-way, from the anaesthesiologist to patient/party. This monologue-leaned communication is neither free flowing nor the patients are allowed to 'speak-up-first' on their concerns or queries. Several gaps can be identified including reluctance on the part of the anaesthesiologist to engage the patients in decision making or not upholding the patient preferences; or patient lacking sufficient knowledge to make an informed choice. Therefore, for risk communication, the very context has to be tailored to patient's individual needs. There is no available study till date which has tried to address as how the communication between patient and the anaesthesiologist is influenced by the 'gender' of the patient concerned. This situates a need to understand how the 'gender' of a patient can influence communication during an Informed consent conversation on anaesthesia risk(s). The study will explore to decipher if difference(s) in patient's gender influence their perceptions and understanding of anesthesia-related risks, and if the difference will influence the future lines of communication involving either of the gender. This prospective study will be based on conversation model based interview designed to assess the nuances of gender- based differences in risk perception and information exchange during pre-anaesthetic consultations.

Начало: 01.12.2027 Край: 01.06.2028 Възраст: 20–60 г.

India Sir Ganga Ram Hospital NCT06814236

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Pilot Randomized Trial of BA-GSH in VA PC-MHI

Depression

Symptoms of depression are highly prevalent among Veterans. However, fewer than 30% of individuals with these symptoms receive any psychotherapy in the Veterans Health Administration (VHA). This is due to many factors, which may include provider availability and patient preferences. Guided self-help (GSH), which involves coaching sessions with patients who are following a fully developed self-help program, has the potential to increase access to care for these Veterans, particularly if implemented within a stepped care model of mental health treatment delivery and if delivered by a diverse set of providers. The VHA's primary care-mental health integration (PCMHI) service, which focuses on short courses of care for mild to moderate symptoms, may be an ideal place in which to deploy GSH. The current project seeks conduct a pilot randomized trial of a GSH program for depression adapted for PCMHI based on behavioral activation.

Начало: 15.10.2027 Край: 30.06.2031 Възраст: от 18 г.

United States VA Office of Research and Development NCT07541482

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Development of a Provider-Focused Intervention to Improve Health Outcomes in Pediatric Sickle Cell Disease

Sickle Cell Disease Sickle Cell Anemia in Children Sickle Cell Disease (SCD) Sickle Cell +1

The goal of this interventional study is to learn about the impact of an intervention for health care providers that teaches individuation and perspective-taking (IPT) skills to enhance patient-centered communication in pediatric sickle cell disease (SCD). The main question it aims to answer is: Does an intervention that teaches individuation and perspective-taking (IPT) skills to pediatric sickle cell disease (SCD) health care providers (HCPs) enhance patient-centered communication? Researchers will compare the IPT intervention to a control group who will receive education about SCD pain management to see if the IPT intervention improves patient-centered communication. Participants will complete baseline surveys and then be randomly assigned into the intervention or control group. After completing their assigned session (IPT training or education), they will be asked to complete the same surveys as completed at baseline.

Начало: 01.09.2027 Край: 30.06.2030 Възраст: от 18 г.

United States Connecticut Children's Medical Center NCT07540767

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Virtual Intervention for Behavioral Health in Emerging Adults; "VIBE in the Parks"

Anxiety Depression

The goal of this study is first to develop and adapt a digital low-intensity treatment, "VIBE in the Parks", for adolescents and young adults (AYA) who visit programming at the Chicago Park District. A trial will occur at four Park District sites to compare how "VIBE in the Parks" works compared to a control condition (where AYA are given access to a digital workbook).

Начало: 01.07.2027 Край: 31.10.2028 Възраст: 13–24 г.

University of Illinois at Chicago NCT07539636

Предстои набиране Фаза 4

Stony Brook Medicine Anti-Inflammatory Trial

Major Depressive Disorder

This is an experimental study designed to measure the effect of celecoxib or minocycline on depressive symptoms in unipolar and bipolar depression. Participants will be equally randomized to either celecoxib or minocycline. All participants will complete a battery of clinical and psychological assessments prior to treatment assignment, and again after treatment completion, to assess any changes or improvements in depression.

Начало: 01.06.2027 Край: 01.01.2032 Възраст: 18–65 г.

Stony Brook University NCT06699966

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A Point of Prostate Cancer Diagnosis Virtual Reality Assistant Intervention in Supporting Newly Diagnosed Black Men

Prostate Carcinoma

This clinical trial tests how well a point of prostate cancer diagnosis (PPCD) virtual reality assistant (ViRA) intervention works in supporting Black men with newly diagnosed prostate cancer. Cancer is the second leading cause of death for African American/Black men, with prostate cancer leading in estimated new cancer cases and second in estimated new cancer deaths. Over 40,000 African American/Black men are diagnosed with prostate cancer annually, with 1 in 6 lifetime probability of developing prostate cancer compared to 1 in 8 probability in White men. The PPCD ViRA provides psycho-oncology support, social determinants of health navigation and emotional support for ethnically diverse African American/Black men newly diagnosed with prostate cancer using artificial intelligence and augmented reality. Using PPCD ViRA may close the prostate cancer care gap for African American/Black men across the cancer continuum and provide emotional, educational, and resource needs of this population when they are visiting a doctor about their prostate health or prostate cancer.

Начало: 01.06.2027 Край: 02.09.2029

United States Mayo Clinic NCT07126548

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