[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammatory-diseases\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammatory-diseases":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,74],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100489688","a-repository-to-study-host-microbiome-interactions-in-health-and-disease-100489688",false,"NCT05656378","A Repository to Study Host-Microbiome Interactions in Health and Disease","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n* Aged \\>0 years. Only participants \\>3 years old will be seen at the NIH CC.\n* Willing to allow biological samples and data to be stored for future research.\n* Willing to provide at least one of the requested biospecimens.\n\nEXCLUSION CRITERIA:\n\n* An individual who has any condition that, in the judgment of the investigator, may put them at undue risk or make them unsuitable for participation in the study will be excluded.\n* For additional gastrointestinal and skin biopsies only, individuals on blood thinners unless they have already been stopped for the procedure.\n* For additional gastrointestinal biopsies only, individuals who have a history of gastrointestinal perforation with endoscopic biopsies will be excluded from the collection of additional gastrointestinal biopsies for the repository.\n* For additional gastrointestinal biopsies only, healthy children (\\\u003C18 years old).\n* For skin biopsies only, individuals who have a history of keloid formation.\n* For vaginal swabs and vaginal fluid only, individuals who have not started menses.\n* For breast milk only, non-lactating individuals.",true,"ALL",{"count":18,"type":19},600,"ESTIMATED","OBSERVATIONAL","Background:\n\nThe microbiome is the bacteria and other microorganisms that live inside and on the body. The microbiome is important for our health. Researchers study how the microbiome help people stay healthy. They study how the microbiome affects the body when people get sick. To do this research, they need samples of the microbiome living on the bodies of many people. The purpose of this natural history study is to collect microbiome samples in a repository. These samples will be used for future research.\n\nObjective:\n\nTo collect microbiome samples from the body that can be used for future research.\n\nEligibility:\n\nPeople of any age. Only those older than 3 years will be seen at the NIH clinic.\n\nDesign:\n\nParticipants will fill out a questionnaire. Topics will include their medical history and foods they eat.\n\nParticipants will be asked to give 1 or more of the following:\n\nStool, urine, saliva, vaginal fluid, and breastmilk. These samples can be collected at home and sent to the researchers.\n\nCells from participants cheek, nose, mouth, skin, rectum, and\u002For vagina. The cells may be collected by rubbing the area with a sterile cotton swab. These procedures can also be done at home.\n\nBlood. Blood may be drawn using a needle inserted into a vein in the arm. For young children, blood may be collected by a prick on the heel or finger.\n\nIntestinal tissue samples. These may be collected from participants who are having an endoscopy or colonoscopy for other reasons.\n\nSkin tissue samples. These may be collected from participants who are having biopsies for other reasons.",[23,24,25,26],"Healthy Controls","Pregnancy","Pediatric Illnesses","Inflammatory Diseases",[28,29,30,24,31],"Microbiome","Host Response","Children","Natural History","RECRUITING","2026-06-27",{"date":35,"type":36},"2026-06-30","ACTUAL",{"date":38,"type":36},"2023-03-09",{"date":40,"type":19},"2032-01-01",{"name":42,"class":43},"National Institute of Allergy and Infectious Diseases (NIAID)","NIH",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":62,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100574295","prospective-observational-study-evaluating-the-safety-and-efficacy-of-immunomodulatory-therapies-in-refractory-inflammatory-and-autoimmune-diseases-100574295","NCT06757426","Prospective Observational Study Evaluating the Safety and Efficacy of Immunomodulatory Therapies in Refractory Inflammatory and Autoimmune Diseases","ARIES","Inclusion Criteria:\n\n1. Patients over 18 years\n2. Enrolled in the French national social security system\n3. Diagnosis of an inflammatory\u002Fautoimmune disease meeting internationally accepted classification criteria;\n4. Clinical activity of their disease with biological and\u002For radiological signs, refractory to conventional therapeutic lines, requiring a new treatment as an addition or replacement according to clinical judgment.\n5. No formal contraindication to the new therapeutic class.\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding (for women of childbearing potential, a negative serum pregnancy test will be required);\n2. History of severe immunosuppression, HIV or HBsAg positive.\n3. Positive QuantiFERON test result (QFT-TBGIn-Tube) for active tuberculosis (latent tuberculosis under treatment may be included).\n4. Have received live vaccines in the 3 months preceding the start of treatment.\n5. History of malignant tumor within the last 5 years.\n6. Severe renal insufficiency (creatinine clearance \\\u003C30mL\u002Fmin\u002F1.73m²)\n7. Liver dysfunction defined by aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 5 times the upper limit of normal.\n8. Blood count abnormality:\n\n   * Platelets \\\u003C 50 x 103\u002Fmm3\n   * Neutropenia \\\u003C 1000\u002Fmm3\n   * Hemoglobin \\\u003C 8 g\u002FdL","18 Years",{"count":54,"type":19},80,"Inflammatory and\u002For autoimmune diseases represent a very broad group of diseases with highly variable clinical features, including - but not limited to - systemic connectivites and vasculitides. As these diseases are rare and heterogeneous, it is difficult to conduct randomized clinical trials in this setting. Refractory cases are therefore treated with drugs that are already available on the market for other indications in more frequent and clinically homogeneous diseases, such as inflammatory rheumatism and haematological malignancies.\n\nPrescribing treatments from other specialties (e.g. rheumatology and oncohaematology) is a reality in the clinical practice of internists and immunologists, often representing an excellent solution for difficult-to-treat inflammatory and\u002For autoimmune diseases. As these molecules are prescribed without the availability of standardized data, it is essential to collect them prospectively to better characterize the efficacy and tolerability of these new therapeutic options in severe inflammatory and\u002For autoimmune diseases.",[57,26],"Autoimmune Diseases",[59,60,61],"autoimmune","inflamatory disease","Refraction","NOT_YET_RECRUITING","2024-12-26",{"date":65,"type":36},"2025-01-03",{"date":67,"type":19},"2025-01-15",{"date":69,"type":19},"2028-07-15",{"name":71,"class":72},"Groupe français d'étude des Maladies Inflammatoires de loeil","OTHER",17,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":15,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100567554","exercise-therapy-in-axial-spa-inflammation-and-biologic-therapy-extasi-b-100567554","NCT06669702","EXercise Therapy in Axial SpA, Inflammation and Biologic Therapy (ExTASI-B)","EXercise As an Anti-inflammatory Treatment in Axial Spondyloarthritis (axSpA) for Patients Taking Biologic Therapy: a Proof of Concept Study (ExTASI-B).","ExTASI-B","Inclusion Criteria:\n\n* Diagnosis of axSpA by a consultant rheumatologist\n* Age=\u002F\\>18 years old\n* Without other significant cardiovascular comorbidities\n* Receiving stable dose biologic treatment\n* Able to commit to the time demands of the study\n\nExclusion Criteria:\n\n* Unable to undertake exercise due to physical or psychological barriers\n* Presence of hip or peripheral joint disease\n* Contraindication to exercise training (American College of Sports Medicine guidelines)\n* Excessively active (score of high on IPAQ)\n* Unable to communicate sufficiently in English\n* Female participants who are pregnant, lactating, or planning pregnancy during the course of the study.\n* Inability to give informed consent or comply with testing and training protocol for any reason.\n* Presence of chronic anaemia (haemoglobin less than 13.5 g\u002FdL for men; less than 12.0 g\u002FdL for women; or haematocrit less than 41.0% in men, less than 36.0% in women.\n* Co-morbidity that the research team determine to be a contraindication to involvement\n\nInclusion and exclusion criteria of healthy controls:\n\nInclusion Criteria:\n\n* Aged between 18 years old and 65 years old\n* Not taking any long-term medication that affects inflammation or immune-mediated inflammation.\n* Free from infection or infection symptoms\n\nExclusion criteria:\n\nThe participant may not enter the study if ANY of the following apply:\n\n* Unable to undertake exercise due to physical or psychological barriers\n* Excessively active (score of high on IPAQ)\n* Unable to communicate sufficiently in English\n* Female participants who are pregnant, lactating, or planning pregnancy during the course of the study.\n* Inability to give informed consent or comply with testing and training protocol for any reason.\n* Have been diagnosed with or are aware of at least one of the following health issues:\n* Immune system disorder\n* Cardiovascular and\u002For cardiometabolic diseases, including but not limited to high blood pressure, high triglycerides and\u002For cholesterol levels, diabetes mellitus, etc.\n* Any chronic health condition that affects one's ability to partake in physical activity\n* Musculoskeletal injury that affects one's ability to partake in physical activity",{"count":83,"type":19},60,"INTERVENTIONAL",[86],"NA","The goal of this randomised controlled trial study is to investigate whether exercise (brisk walking, equal to 13 on a rating of perceived exertion scale; somewhat hard) can be used as an adjuvant therapy for people living with axial spondyloarthritis and taking biologic medications to further improve their quality of life and lower their symptoms and disease burden. The main questions it aims to answer are:\n\nDoes a 12-week structured home-based aerobic exercise intervention have a favourable effect on markers of immune-mediated inflammation and symptom severity?\n\nAs a secondary aim and outcome, this study will investigate:\n\n* The acceptability of this intervention using questionnaires with free text boxes and one-to-one semi-structured interviews in a subset (50%) of participants (Q-ExTASI-B substudy).\n* The effect of the home-based intervention on circulating markers of cardiometabolic health, anthropometrical measures, and immune markers that associate with systemic inflammation.\n* The effect of the home-based intervention on objective measures of physical function and exercise tolerance\n\nThe study will compare the data of a healthy group with that of people living with axial spondyloarthritis. Within the patient population, 20 of the individuals will be allocated to the exercise group (randomly), and 20 will be allocated to the usual care group. In the exercise group, participants will be asked to do 30 minutes of brisk walking five days a week for 12 weeks, and they will be visiting Loughborough University every four weeks to provide blood samples and fill out questionnaires. Participants in the usual care group will continue with their current care routine and will visit the study site to provide blood samples and questionnaire data every 4 weeks. The data from all axSpA patients will be compared to healthy controls, and subgroup analysis will be conducted to investigate the difference between the exercise group and the usual care group.",[89,26,90],"Axial Spondyloarthrithis","Arthritis",[92,93,94],"Exercise","Inflammation","Immunosenescence","2024-11-03",{"date":97,"type":36},"2024-11-05",{"date":99,"type":36},"2024-08-01",{"date":101,"type":19},"2029-07-31",{"name":103,"class":72},"Loughborough University",2]