Autoimmune diseases involve the immune system mistakenly targeting the body’s own tissues, leading to chronic inflammation and varied health challenges. Clinical trials in autoimmune disease explore treatment evaluations to modulate immune responses ...
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Systemic lupus erythematosus SLE is an autoimmune disease affecting multiple body systems, with skin involvement being one of the earliest and most common features. This research evaluates the role of TREX1 gene mutations and certain autoantibodies in SLE, especially how these genetic factors relate to skin symptoms and disease activity. The study focuses on understanding these connections in Egyptian patients to improve early diagnosis and personalized treatment. The study involves about 60 patients diagnosed with SLE who have at least one skin manifestation, compared with 30 healthy volunteers matched by age and sex. Researchers will assess selected autoantibodies and TREX1 gene polymorphisms to explore their prevalence and connection to clinical features. This is an observational study without treatment interventions. Participants will provide informed consent and undergo genetic testing and autoantibody assessments. Researchers will monitor disease activity and gene polymorphisms over a 3-month period. The study aims to correlate genetic and antibody findings with disease symptoms and activity to better understand SLEs impact on the skin and overall health.
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Researchers are investigating how balance and walking abilities relate to detailed movement measurements in people with Multiple Sclerosis MS. This observational study focuses on understanding the connection between clinical tests of function and objective biomechanical data. The goal is to identify which movement characteristics best reflect balance, gait, and physical performance challenges faced by individuals with MS. Participants will attend a single laboratory session where they undergo biomechanical analysis using the Vicon motion capture system. They will complete functional assessments of balance, gait, and physical performance, as well as questionnaires about fear of falling and fatigue. Spasticity in the lower limbs will also be assessed during this visit. During the session, participants will perform tests such as the mini-BESTest for balance, Functional Gait Assessment, Short Physical Performance Battery, and a 2-minute walk test. Questionnaires like the Fall Efficacy Scale and Fatigue Severity Scale will be completed. Researchers will analyze these collected data to explore how biomechanical and functional measures relate, aiming to improve assessment tools for MS rehabilitation.
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This research aims to determine whether supplementation with vitamin E alpha-tocopherol reduces inflammation and clinical activity in patients with rheumatoid arthritis RA. RA is a common autoimmune disease causing chronic joint inflammation and potential joint damage, which leads to disability and affects quality of life. The study focuses on patients with early RA who have low vitamin E intake and are already receiving standard RA treatments. Participants will be randomly assigned to one of two groups one group will receive conventional synthetic disease-modifying antirheumatic drugs FARMEs plus 800 mg per day of vitamin E, while the other group will receive the same FARMEs plus a 200 mg per day magnesium oxide placebo. The supplementation lasts for one month, with participants taking two capsules daily, one in the morning and one in the afternoon. During the study, participants will attend clinic visits at the start and end of the supplementation period for assessments including clinical activity, blood tests measuring vitamin E levels, inflammatory markers, autoantibodies, and antioxidant capacity. They will keep a diary to track symptoms and supplement intake. Researchers will evaluate changes in vitamin E levels, clinical disease activity DAS-28, pro-inflammatory cytokines, acute phase reactants, and autoantibodies to understand the impact of vitamin E supplementation on RA.
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Researchers are evaluating a new, affordable way to monitor people with multiple sclerosis MS using patient-recorded selfie videos. This study aims to see if videos collected remotely on a mobile phone can provide the same walking and speech information as traditional in-person visits. The goal is to create a low-burden, patient-centered method that can be used widely and easily by diverse people with MS. Participants will record five short selfie videos at home during baseline, 3 months, 6 months, and 12 months. They will also attend in-person visits at baseline, 6 months, and 12 months for additional data collection. These videos capture daily activities like walking and talking, using the participants own device such as a smartphone, tablet, or computer without special software. During the study, participants will undergo several assessments including video uploads and in-person evaluations lasting about 15 minutes for video collection and one hour for in-person visits. Researchers will measure how well video data matches standard MS functional tests, the usability of the video method, and its ability to detect subtle changes over time. The study lasts one year and aims to improve remote monitoring for people living with MS.
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This research aims to understand if sexual activity affects the risk of low blood sugar hypoglycemia in adults with type 1 or type 2 diabetes who use insulin therapy and continuous glucose monitoring CGM. Sexual health is important but often overlooked in diabetes care, and fear of hypoglycemia during or after sexual activity may reduce quality of life. The study addresses this gap using new remote monitoring technology to study glucose changes related to sexual activity. Participants will use CGM systems like LibreView or Dexcom Clarity to track glucose levels during and up to 6 hours after sexual activity, which they mark in their CGM app using a neutral symbol. The study is observational with no assigned treatments participants continue their usual insulin therapy and self-management. Each person will be observed for 3 months, comparing glucose data from sexual activity days to days without sexual activity. During the study, researchers will collect glucose data remotely and receive basic clinical information from healthcare providers. They will analyze the proportion of sexual activity episodes linked to hypoglycemia and compare frequency and mean glucose levels on days with and without sexual activity. Participants data are anonymized and securely handled. The study hopes to help reduce patient fears and guide future recommendations for safe sexual activity with insulin therapy.
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Researchers are studying pulmonary arterial hypertension PAH, including its common subtypes idiopathic PAH IPAH and connective tissue disease-associated PAH PAH-CTD. The study aims to develop pulmonary vascular biomarker signatures using hyperpolarized 129Xe MRI to differentiate these subtypes and to evaluate the ability of this imaging to monitor disease progression and treatment response over time. Additional assessments such as laboratory tests, echocardiography, and six-minute walk distance 6MWD are also used to support these evaluations. The study is observational and enrolls 20 subjects divided into two groups 10 with IPAH and 10 with PAH-CTD. Participants will undergo hyperpolarized 129Xe MRI and MR spectroscopy at baseline, 3 months, 6 months, and 12 months. Alongside imaging, data from standard clinical assessments including labs, echocardiography, and 6MWD will be collected at these same timepoints to track changes. Participants will be monitored for changes in pulmonary vascular remodeling, red blood cell oscillation amplitude, 6MWD, NTproBNP levels, and WHO functional class over one year. Safety is assessed by tracking adverse events, serious adverse events, withdrawals, and specific examinations such as electrocardiograms and vital signs. The total follow-up period for each participant is one year, with multiple scheduled evaluations to comprehensively assess disease status and response.
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This research aims to compare a new spinal cord imaging technique called the 3D OPTIMIZED WMN MPRAGE sequence with conventional MRI sequences for people with multiple sclerosis. Multiple sclerosis is a common inflammatory disease affecting the central nervous system, often causing spinal cord damage that leads to symptoms like sensory loss, pain, weakness, and bladder or bowel problems. Imaging the spinal cord is important for diagnosis and prognosis, but current methods have limitations in detecting lesions accurately. The study involves scanning patients at the cervical and thoracic levels of the spinal cord using both conventional MRI sequences including 2D sagittal T2 FSE, 2D sagittal STIR, 2D sagittal PSIR, and 3D MPRAGE and the new 3D OPTIMIZED WMN MPRAGE sequence. At the cervical level, the new sequence will be acquired in sagittal and axial views, while at the thoracic level it will be acquired sagittally. This comparison will help assess whether the new sequence provides better detection of spinal cord lesions. Participants will undergo MRI scans at one visit where researchers will evaluate the number and volume of lesions, presence of artifacts, contrast quality, and the relation of lesions to the patients disability. The study will also measure sensitivity, positive predictive value, and reproducibility of the new imaging method. The total participation time corresponds to the imaging session on day one, with no long-term follow-up reported.
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Researchers are studying whether the PET radiotracer 68Ga-FAPI-46 can detect fibrostenosing Crohns disease in the small bowel. This early phase 1 case-control study aims to understand if early or developing fibrosis areas take up the tracer, which binds to fibroblast activation protein FAP. Participants with small bowel Crohns disease will be grouped based on imaging results to compare tracer uptake between those with and without strictures. Participants will receive a PETCT scan using the radioactive tracer Gallium-68-labeled fibroblast activation protein inhibitor-46 68Ga-FAPI-46, administered intravenously at a dose of 5 mCi 10%. Cases include participants with small bowel strictures or probable strictures, while controls include those without strictures but may have other disease features. This design allows researchers to investigate different stages of fibrosis development in Crohns disease. During the study, participants will complete the PETCT scan with 68Ga-FAPI-46. Researchers will monitor the completion rates of these scans over an average of 2 years. Participants will be evaluated through imaging and clinical assessments related to their Crohns disease status. Safety, tracer uptake patterns, and disease characteristics will be documented throughout the study period.
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Researchers are exploring the potential use of the imaging agent 68Ga Ga-FAPI in PETCT scans for diagnosing and monitoring various chronic inflammatory and fibrotic diseases. This pilot study focuses on 13 different clinical conditions such as rheumatoid arthritis, liver fibrosis, and systemic lupus to assess whether this new radiotracer can improve disease evaluation compared to current methods. The study aims to gather initial data to guide further development and possible routine use of this imaging technique in these diseases. Participants receive a 68Ga Ga-FAPI PETCT scan in addition to their usual medical care. The imaging is performed either once at baseline or longitudinally at baseline and again at 3 and 6 months if their treatment is intensified at inclusion. This approach allows researchers to observe how the radiotracer behaves in different diseases and over time, helping to refine its clinical application. During the study, participants undergo PETCT scans to measure the intensity of the PET uptake and correlate these findings with pathology evaluations, biomarkers, functional parameters, and imaging characteristics at baseline, 3 months, and 6 months. This detailed assessment helps to understand the diagnostic value of 68Ga Ga-FAPI in chronic inflammatory and fibrotic conditions. The study runs until October 2028 and is conducted at a single center, with participants followed through these imaging and clinical evaluations.
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Researchers are investigating how the medicine Filgotinib works to relieve pain in patients with moderate to severe active rheumatoid arthritis RA. This study focuses on understanding two main factors influencing pain relief brain pathways linked to central nervous system sensitization seen in fibromyalgia, and the inflammation surrounding joints and related immune signals. The study aims to clarify why Filgotinib may provide faster pain relief compared to other treatments by examining these mechanisms. Participants prescribed Filgotinib will be observed using advanced 7 Tesla MRI brain imaging to measure changes in brain connectivity and glutamate levels associated with pain processing. The study will assess Filgotinibs impact on both central nervous system pain pathways and peripheral inflammation over periods of up to 12 weeks. This observational test-retest design does not involve altering prescribed treatments but focuses on detailed imaging and biological assessments. During the study, participants will undergo brain MRIs and evaluations of joint inflammation through ultrasound and blood tests measuring cytokines and chemokines. They will also complete questionnaires on pain, fatigue, anxiety, sleep, and cognitive function. Researchers will monitor changes in these measures at intervals up to 12 weeks to understand how Filgotinib affects pain and related symptoms. Total participation time aligns with the 12-week observation period.
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