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 SLE's impact on the skin and overall health.
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Researchers are investigating the relationship between functional measures of balance and gait and objective kinetic and kinematic parameters in people with Multiple Sclerosis (MS). This cross-sectional observational study aims to understand how biomechanical gait and balance data collected through the Vicon motion analysis system relate to clinical assessments of balance, gait, and physical performance. The study seeks to identify which biomechanical factors are most closely linked to functional abilities and mobility challenges in MS. Participants will attend a single laboratory session where they will undergo biomechanical analysis of balance and gait using the Vicon motion capture system. They will also complete standardized functional tests including the Mini Balance Evaluation Systems Test, Functional Gait Assessment, Short Physical Performance Battery, and a 2-Minute Walk Test. Additionally, they will fill out questionnaires assessing fear of falling and fatigue and have their lower-limb spasticity evaluated with the modified Ashworth Scale. During the session, which takes about 40 minutes for the primary kinetic and kinematic analysis and additional time for functional assessments, researchers will collect detailed movement data alongside clinical measures. This data will be analyzed to explore correlations between biomechanical parameters and functional outcomes. The study includes assessments of postural control, gait performance, physical endurance, fatigue, and spasticity. The findings aim to improve understanding of movement impairments in MS and support better clinical assessments and rehabilitation approaches.
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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 participant's 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 patient's 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 Crohn's 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 Crohn's disease will be grouped based on imaging results to compare tracer uptake between those with and without strictures. Participants will receive a PET/CT 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 Crohn's disease. During the study, participants will complete the PET/CT 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 Crohn's disease status. Safety, tracer uptake patterns, and disease characteristics will be documented throughout the study period.
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Researchers are studying the use of the imaging agent 68Ga Ga-FAPI in PET/CT scans to explore its potential in diagnosing and monitoring various chronic inflammatory and fibrotic diseases. This pilot study involves 13 different clinical conditions such as rheumatoid arthritis, liver fibrosis, systemic lupus, and others. The goal is to determine if this new imaging method can improve disease evaluation and support further clinical development in these areas. The study adds a 68Ga Ga-FAPI PET/CT scan to usual routine care. Depending on the condition and treatment plan, patients may have this scan once at the start or multiple times over 3 to 6 months if their therapy is intensified. This imaging agent targets the fibroblast activation protein (FAP), which is involved in tissue remodeling and fibrosis, helping to highlight disease activity in affected tissues. Participants will undergo the PET/CT scans along with routine clinical evaluations and may be followed up at baseline, 3 months, and 6 months. Researchers will measure PET uptake intensity and correlate imaging results with pathology findings, biomarkers, functional parameters, and imaging characteristics over time. The study aims to assess the usefulness of 68Ga Ga-FAPI PET/CT in improving diagnosis and monitoring of these chronic diseases while participants continue their usual care.
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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 Filgotinib's 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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