865 Clinical Trials for Various Conditions
The goal of this clinical trial is to learn if mirikizumab works to treat pouch disorders in adults. The main questions it aims to answer are: Does mirikizumab reduce symptoms of pouch disorders Participants will: Take mirikizumab every 4 weeks for one year Visit the clinic once every month for two months and at the end of the study Keep a diary of their symptoms
The proposed study is a block-randomized, controlled trial to evaluate the effects of a digital meditation and mindfulness practice on mental health in patients with non-infectious uveitis.
Measure serum and cerebrospinal fluid Sema4A levels in female subjects with newly diagnosed and untreated relapsing multiple sclerosis, clinically stable relapsing multiple sclerosis receiving disease modifying therapy, relapsing multiple sclerosis receiving disease modifying therapy with breakthrough disease, or non-multiple sclerosis controls (patients without inflammatory central nervous system disease).
The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.
This phase I trial will assess primarily the safety and secondarily the anti-inflammatory and anti-neovascular effect of Episcleral Celecoxib in patients suffering from macular edema and other inflammatory disorders of the retina, choroid and vitreous.
This phase I trial will assess primarily the safety and secondarily anti-inflammatory effect of Episcleral Dexamethasone in patients suffering from macular edema and other disorders of the retina, choroid and vitreous.
This study will use brain Positron Emission Tomography/ Magnetic Resonance Imaging (PET/MRI) and an investigational radioactive drug called \[Zr-89\]oxine to track the location of white blood cells (also called leukocytes) in the body. PET/MRI will be used to visualize labeled white blood cells and determine if they enter the central nervous system in conditions associated with brain inflammation (also called neuroinflammation). By better understanding the role of neuroinflammation in fibromyalgia, chronic fatigue syndrome, and multiple sclerosis, the investigator hopes to be able to better diagnose and treat patients in the future.
The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical \[F-18\]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer \[F-18\]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as measured with \[F-18\]DPA-714-PET/MRI.
Pilot study to determine feasibility for treating patients with two chronic inflammatory conditions of the urinary bladder: chronic interstitial cystitis and recurrent urinary tract infections using a standardized hyperbaric oxygen treatment plan. Presently there are no good treatments for these conditions and hyperbaric oxygen may be a safe and readily accessible therapy as it has proven successful an another type of chronic inflammatory condition of the urinary bladder known as "radiation cystitis". The study will determine if patients will consider this an acceptable treatment for their conditions and that it is well tolerated.
Musculoskeletal disorders and degeneration represent injuries or pain in the body's joint ligaments, tendons, muscles, nerves, and skeletal elements that support extremities, spine and related tissues. Direct injuries and aging contribute to breakdown and inflammation of these tissues, leading to debilitation and loss of function in these areas. This has major impact on quality of life, occupational/recreation limitations, and psychosocial implications. Many therapies have been employed including medications, physical therapy, occupational therapy, and a variety of surgical interventions each of which have distinct limitations, often covering the issues versus providing actual healing and return to function. Many reports are now available utilizing self-healing options which include use of stem/stromal cellular therapy or biocellular treatments (either from adipose or marrow) using targeted placement of cells, matrix and platelet concentrates. Termed cellular or Biocellular therapy (typically optimized using ultrasound guidance). It is proposed that use of cellular isolates or cell-stroma derived from the largest deposit of these cells (adipose greater than marrow), may use in conjunction with targeted placement or as a stand alone methodology intravascular use. This study is designed as a interventional means to examine the safety and efficacy of the use of cellular and tissue stromal vascular fraction in musculoskeletal pain, dysfunction degeneration or inflammatory disorders.
This pilot trial studies how well fluorine F 18 clofarabine positron emission tomography (PET)/computed tomography (CT) works in imaging patients with autoimmune or inflammatory diseases. Fluorine F 18 clofarabine is an imaging agent or tracer which may be taken up by inflammatory tissue in the body. Diagnostic imaging, such as PET/CT scans, can be used to measure the amount of injected tracer that is taken up by inflammatory tissue. PET/CT scan may help to determine how fluorine F 18 clofarabine is distributed throughout the body.
Background: Uveitis is a serious eye disease that can cause vision loss. Treatment sometimes causes serious side effects or does not work. Researchers want to learn more about uveitis and why some people develop it. Objective: To learn clinical and genetic factors that may make people develop uveitis and influence how they respond to treatment. Eligibility: People ages 8 and older who have uveitis, scleritis, inflammatory eye disease, or a disease related to eye inflammation INCLUSION CRITERIA FOR COVID-19 COHORT: Participants with COVID-19 will be eligible if they: 1. Have a diagnosis of COVID-19 confirmed by a nasaopharyngeal swab (or another confirmative test) within less than or equal to 3 days prior, with symptoms of any severity. 2. Are able to give verbal consent. 3. Are 16 years of age or older. EXCLUSION CRITERIA FOR COVID-19 COHORT: Participants with COVID-19 will not be eligible if they: 1. Use regular prescription eye drops on the day of sampling. 2. Current use of antiviral medications. Design: Participants will be screened with: Medical history Physical exam Eye exam Participation lasts up to 10 years. The clinic visit schedule varies depending on participants eye disease: Baseline visit with annual follow-ups Baseline visit, visits at months 3 and 6, and annual follow-ups Another schedule set by the researcher Depending on participants eye disease, tests during each visit could include: Fluorescein angiography or indocyanine green angiography: Dye is injected through a needle in the arm and flows through the blood vessels in the eye. A camera takes pictures of the eye. Electroretinography: Participants sit in the dark with their eyes patched. After 30 minutes, numbing drops and contact lenses are put in the eyes. Then, the retina is stimulated with flashing lights. Perimetry: Participants look into a bowl or lens and press a button when they see a light. Conjunctival or corneal biopsy, or skin biopsy: A small piece of tissue is removed. Anterior chamber tap: A needle enters the eye to remove fluid. Blood and urine tests Saliva, stool, hair, or tear samples Cotton swab of the inside of the cheek. During the study, participants may need immunosuppressive treatment, such as drugs or injections in or around the eyes depending on their disease.
The primary objective is to assess the effect of short-term diet modification on the microbiome composition, and inflammatory/metabolic disease markers in Antiretroviral therapy (ART)-treated HIV-infected participants and Human immunodeficiency virus (HIV)-negative controls in the United States.
The purpose of the study is to test the investigational drug Gamunex-C on the growth of blood vessels over the cornea. This study is being conducted by Dr. Balamurali Ambati at the Moran Eye Center at the University of Utah. The cornea is the clear outer front part of the eye. In corneal neovascularization, blood vessels grow over the cornea. Corneal neovascularization and ocular anterior segment inflammations are sight-threatening conditions. Lipid deposition and edema with subsequent scar formation can compromise corneal clarity irreversibly. Corneal neovascularization is also a well recognized risk factor for corneal graft failure. In its natural state, the cornea is a site of immune privilege well suited to tissue transplantation. Once vascularized, there is direct exposure of corneal antigens to circulating host immune mechanisms greatly increasing the chance of rejection \[Collaborative Corneal Transplantation Study\]. Melting or inflammation in the anterior chamber, cornea, or ocular surface can cause irreversible scarring or destruction of the optical elements of the eye, which can compromise vision. Current standard of care for such conditions includes use of topical steroids and sometimes immunosuppressants (e.g., cyclosporine). These do not address a common underlying corneal neovascularization or melting. This is a Phase 1 clinical trial of subconjunctival IVIg (Gamunex-C) injection for treatment of corneal neovascularization in the setting of corneal transplantation with neovascularization. Candidates for corneal transplantation with corneal neovascularization in one or more quadrants crossing more than 0.5mm over the limbus will be identified for inclusion in our study.
Background: - Uveitis is a general term describing a group of inflammatory diseases of the eye. The causes of uveitis are not fully understood. Researchers want to look at bacteria in the body that might be related to the inflammation. They will study the natural bacteria present in the gut and intestines of people with and without uveitis to understand their potential role in these diseases. Objectives: - To study the intestinal bacteria in people with and without uveitis or ocular inflammatory disease. Eligibility: * Individuals at least 18 years of age who have uveitis or ocular inflammatory disease. * Individuals at least 18 years of age without uveitis or ocular inflammatory disease to serve as healthy controls. Design: * Participants may have more than one study visit (approximately 2-4) to assess possible changes in microbiome composition associated with treatment or disease activity. * At each visit, participants will have a full eye examination, including vision and eye pressure tests. They will provide blood samples for testing. Participants will also be provided a stool collection kit to take home. The samples may be sent or brought back to the clinic. * Treatment will not be provided as part of this study.
The goal of this study is to examine if chronic cherry consumption will decrease lipid peroxidation and serum concentration of inflammatory markers in human subjects with elevated serum C reactive protein (CRP), and to examine the relationship between serum concentrations of CRP and polyphenols. The investigators hypothesize that cherry consumption will reduce serum concentration of inflammatory markers, including CRP, inflammatory cytokines and adhesion molecules.
The CORRONA CERTAIN Sub-study of the Consortium of Rheumatology Researchers of North America, Inc. is a Sub-study of the CORRONA Data Collection Program. The CERTAIN Sub-study is designed to systematically collect and document use patterns, effectiveness, comparative effectiveness and safety of biologic agents used in the management of Rheumatoid Arthritis (RA).
The investigators hypothesize that text message reminders to girls diagnosed with pelvic inflammatory disease (PID) in the emergency department (ED) will improve follow-up to their primary care provider (PCP) after being discharged from the ED.
Background: - The Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) is conducting a variety of laboratory research experiments that require blood, bone marrow, urine, stool, and/or tissue samples from patients with a diagnosis of an immunologic, autoimmune, or inflammatory disorder, as well as from their healthy relatives. Donated samples will be sent to the CHI laboratory at the National Institutes of Health to be used in research that may provide more information on the changes in the immune system caused by these specific disorders. Objectives: - To collect blood, leukapheresis cells, bone marrow, urine, stool, cheek swab, and tissue samples from patients with immune-mediated and inflammatory diseases, as well as from family members, for ongoing exploratory research studies. Eligibility: * Individuals at least 2 years of age who have been diagnosed with an immune-mediated or inflammatory disease, or have signs or symptoms of an immune or inflammatory disease without a formal diagnosis. * Immediate family members (parent, child, sibling, grandchild) of the above mentioned individuals. Design: * Participants will be screened with a complete medical history, physical examination, and blood and urine samples. * Participants will provide blood, urine, stool, cheek swab, and tissue samples as required by the study researchers. * Participants who have immune or inflammatory diseases will also provide blood and bone marrow samples collected through biopsies and leukapheresis (to collect specific blood cells). * Adult relatives will provide additional samples through more invasive procedures such as leukapheresis and bone marrow biopsies. Child relatives (between 2 and 18 years of age) will not undergo these invasive procedures. * No treatment will be provided as part of this protocol.
The purpose of the study is to determine whether positron emission tomography using the new imaging agent 18F-FAC can be used for imaging cancer and/or inflammation.
The purpose of this study is to determine the biodistribution of a new agent 1-L-(2 deoxy-2,-18fluoroarabinofuranosyl) cytosine non-invasively in healthy humans and to evaluate whether it can be used to image cancer, autoimmune disease, and inflammation
This study is a randomized placebo-controlled trial comparing two antibiotic treatment regimens for acute PID. Women with acute PID will be randomized to one of two treatment regimens: 1) a single intramuscular dose of ceftriaxone 250 mg, doxycycline 100 mg orally twice a day for 14 days, along with placebo tablets orally twice a day for 14 days or 2) same doses of ceftriaxone and doxycycline, and metronidazole 500 mg orally twice a day for 14 days. The primary objective is to compare the eradication of anaerobic organisms from the upper genital tract between women who receive standard outpatient antibiotic treatment to those who receive standard outpatient treatment along with a two-week course of metronidazole.
Background: - Laboratory research studies require control samples from healthy volunteers to compare with samples from patients. These studies will help researchers better understand and refine treatments for immune system and inflammatory diseases. Objective: - To obtain blood, urine, buccal (mouth) mucosa, normal tissue and bone marrow samples and/or leukopheresis cells from healthy volunteers. Eligibility: - Healthy individuals at least 8 years of age. Design: * Volunteers will be recruited through the Program for Healthy Volunteers, Patient Recruitment and Public Liaison Office, or self-referral through the clinicaltrials.gov Web site. * Health will be confirmed by a brief history and physical examination and blood work. * Volunteers 8 years of age and older will provide blood and urine samples using standard procedures. Buccal mucosa samples will be obtained by scraping the insides of both cheeks with a sterile nylon brush. * Bone marrow samples will be obtained from volunteers 18 years of age and older by taking two aspirates from the posterior iliac crest (an area near the hip). * Normal tissue samples will be obtained from volunteers 18 years of age and older by taking superficial skin samples (punch biopsies) * Leukopheresis or lymphapheresis will be performed on volunteers 18 years of age and older to obtain white blood cells for research * Samples will be assigned a unique code and will be stored until they are no longer of scientific value or the volunteer withdraws consent for their use.
The purpose of this study is to determine if certain levels of proteins lead to inflammation of the gums. One example of such proteins being studied is called Interleukin 1 (IL-1). This protein is found at higher levels in areas of inflammation. This type of study is called an experimental gingivitis study. It will involve stopping your routine oral health care for 21 days. If you qualify, you will receive a full dental cleaning at the beginning and end of the study. Approximately 30 patients will participate in this study at the Michigan Center for Oral Health Research (MCOHR).
The purpose of this study is to provide data correlating levels of microparticles that circulate in the blood and disease activity in children with inflammatory bowel disease (IBD). The hypothesis is that circulating microparticles will be higher in children with active IBD, show inflammatory activity, and will be low in patients in remission as well as in healthy controls.
Background: * For every CHI research study, patients must fulfill a list of criteria, based primarily on their medical condition. To determine whether a patient meets these eligibility criteria to participate in a research protocol, researchers must perform a series of diagnostic tests and procedures. * These evaluations are designed to evaluate a participant s general medical condition (i.e., blood tests, function of certain organs such as the lungs, heart, liver, or kidneys), and to confirm a diagnosis or ensure that a healthy volunteer is in good condition. They maximize the safety for the patients and healthy volunteers at CHI. Objective: - To determine the eligibility of patients and healthy volunteers for active CHI research protocols. Eligibility: * The procedures included in this protocol will determine eligibility for active CHI research protocols. * Both healthy volunteers and patients will be evaluated. Design: * Required tests and procedures for various research studies may include the following: history and physical examination, blood and urine tests, lung and heart function tests (echocardiogram, electrocardiogram, stress test), imaging studies (X-rays, magnetic resonance imaging (MRI), computerized tomography (CT), and tissue collection. * Participants will be asked to undergo tests only for the study or studies for which they are being considered. The research team will provide further information on any additional tests that may be required. * After all eligibility assessments are complete, participants may be offered participation in one or more CHI research protocols or referred back to a home physician.
This study will examine whether a medicine called canakinumab is safe and effective for treating patients with neonatal-onset multisystem inflammatory disease (NOMID), also known as chronic infantile neurologic, cutaneous, articular (CINCA) syndrome. This disease can cause rash, joint deformities, brain inflammation, problems with the eyes and learning difficulties. Canakinumab is an experimental drug that inhibits the action of a protein produced by the body called human IL-1beta, which is responsible for the symptoms in NOMID and also contributes to many other kinds of inflammatory diseases. Patients 2 years of age and older with NOMID / CINCA may be eligible for this study. Participants undergo the following procedures: Screening Phase * Medical history and review of medical records * Blood tests * Daily diary of symptoms and medicines take Washout/Lead-in Phase * Discontinuation of anakinra or other medications, a 6 to 48-hour run-in period (only for patients who discontinued anakinra or other IL-1 blocking therapy). Treatment Phase * Injection of canakinumab under the skin every 8 weeks for 6 months * Monitoring and evaluations during treatment, including: * Quality-of-life questionnaires and daily diary * Vital signs measurements (heartbeat, blood pressure, temperature) * Blood tests * Electrocardiogram * Tuberculosis skin test * Neurological, eye and skin examinations at beginning and end of study * Cognitive evaluation at beginning and end of study * Lumbar puncture (spinal tap) at the beginning of the study, 2 weeks after the second dosing of canakinumab and at the end of the study * X-rays and bone density scan at beginning and end of study * Magnetic resonance imaging (MRI) of the head at beginning and end of study Follow-up Phase * Monthly clinic visits after the last dose of canakinumab for a minimum of 60 days End-of-Study Evaluation * Series of tests 8 weeks after last dose of canakinumab to evaluate treatment response and side effects
This will provided long-term safety and efficacy data for ACZ885 (a fully human anti-interleukin-1β \[anti-IL-1β\] monoclonal antibody) given as an injection subcutaneously in patients who participated in the CACZ885A2102 (NCT00487708), CACZ885D2201 (NCT00685373) or CACZ885D2304(NCT00465985) studies or newly identified patients with the following cryopyrin-associated periodic syndromes: Familial Cold Autoinflammatory Syndrome, Muckle-Wells Syndrome or Neonatal Onset Multisystem Inflammatory Disease. The duration of this study was 6 months with a maximum duration of 2 years
This study will evaluate and follow patients with various allergic, hypersensitivity and inflammatory disorders. The protocol is not designed to test new treatments; patients will be managed with standard of care therapies. Participants may be referred to other current NIAID protocols as appropriate or to new studies as they are developed, but will not be required to join another study. Patients with allergic, hypersensitivity or inflammatory disorders between the ages of 3 years and 80 years may be eligible for this study. Conditions of interest include, but are not limited to, asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy. Participants will have a medical history and physical examination, plus standard tests for diagnosing and treating their specific disorder. Tests may include routine blood and urine studies, X-rays or other imaging studies, allergy skin tests and lung function tests. Blood samples may be collected for research on immune system cells and other substances involved in immune function. Generally, about 2 to 6 tablespoons will be drawn at a time, but no more than 16 ounces will be collected over a 6-week period. NIH does not provide emergency medical treatment or treatment for other, unrelated conditions the patient may have. Therefore, patients must maintain a personal physician for these purposes.
This study will collect blood samples from patients with non-infectious eye inflammatory diseases a spectrum of eye disorders that can produce sight-threatening vision loss. The blood will be analyzed for substances that may provide a better understanding of the nature of these disorders, possibly leading to improved treatments. Treatment is not offered under this protocol. Patients 6 years of age and older with an eye inflammatory disease, including non-infectious uveitis, ocular cicatricial pemphigoid, non-infectious scleritis, episcleritis, Stevens Johnson syndrome, Moorens ulcer, peripheral ulcerative keratitis and keratoconjunctivitis sicca, may be eligible for this study. Patients may or may not currently be participating in a treatment trial. Participants will have blood drawn through a needle in an arm vein. More samples may be collected if patients enrolled in another study are scheduled for additional visits. No more than 4 teaspoonfuls of blood will be collected at any one time.