Angioedema involves episodes of rapid swelling beneath the skin, often affecting the face, throat, and limbs. Clinical trials for angioedema explore various treatment evaluations to control or prevent swelling episodes, improve quality of life, and r...
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Found 57 Actively Recruiting clinical trials
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Hereditary Angioedema (HAE) is a rare condition causing sudden swelling under the skin and inside the body, such as in the belly, throat, or genitals. This swelling results from a temporary leak in blood vessels and does not cause itching or hives. HAE is classified by the level of a blood protein called C1 inhibitor (C1-INH), with some patients having normal levels and others having limited or insufficient levels. This research focuses on children with HAE who have C1-INH deficiency and have been treated with lanadelumab as a preventive therapy. The study aims to understand how well lanadelumab works in real-life settings by measuring how long children remain free of HAE attacks. The study is observational and collects existing data from medical records of pediatric patients aged 2 to under 12 years who started long-term prophylaxis treatment with lanadelumab during routine care. No new treatments are given as part of the study. Researchers will analyze various outcomes over a period of up to 13 months, including attack rates, attack severity and location, treatment patterns, healthcare usage, and any side effects or reactions to the injections. Participants' involvement includes reviewing their medical history and treatment records to assess the effectiveness and safety of lanadelumab. The main outcome measured is the percentage of children who remain free of HAE attacks during the study period. Other important data include healthcare visits, hospital stays, and adverse events. The study will provide insights based on up to 13 months of follow-up information per participant without requiring additional visits or interventions.
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Hereditary angioedema (HAE) is a rare condition causing sudden swelling under the skin and inside the body, such as in the belly, throat, or genitals. This swelling is due to temporary blood vessel leaks and does not cause itching or hives. The study focuses on people with HAE-C1INH Type 1 or 2 who have been using Takhzyro4 (lanadelumab) to prevent HAE attacks, aiming to evaluate how well this treatment reduces disease activity in everyday life after 6 to 12 months of use. This observational study will collect retrospective clinical data from medical records for participants diagnosed with HAE-C1INH Type 1 or 2 who started long-term prophylaxis with Takhzyro4. Data from before the first Takhzyro4 dose (pre-index) and at least 6 months after the first dose (post-index) will be examined to assess treatment outcomes. No new treatment will be given as part of the study. Participants' medical records will be reviewed to track changes in HAE activity scores, quality of life, and attack frequency before and after treatment, with data collected between September 2025 and February 2026. The study will also explore factors affecting treatment response. Follow-up can last up to 12 months after the first Takhzyro4 dose unless treatment stops, the patient dies, or is lost to follow-up.
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Researchers are studying hereditary angioedema (HAE), a rare condition causing sudden swelling under the skin and inside the body, such as in the belly, throat, or genitals. This swelling is due to temporary blood vessel leakage and does not cause itching or hives. The study focuses on testing the effectiveness of measuring the function of a protein called C1-inhibitor (C1INH) alone to diagnose two types of HAE: HAE-C1INH-Type1 and HAE-C1INH-Type2, compared to the standard tests used in Algeria. The study also aims to establish a reference value for this test and collect health background information from participants. During the study, all participants will undergo two diagnostic methods: the new test measuring C1INH function alone (using the Technochrom C1-INH Kit) and the standard of care (SoC) tests, which include measuring C4 and C1-INH antigenic levels and function. For participants with new or conflicting test results, a second confirmatory test will be performed, and if needed, a third test. Participants suspected of HAE or family members of known HAE cases will be enrolled. They may visit the clinic up to three times, with no further follow-up planned after testing. Participants will provide health history data, including age at diagnosis, symptoms, diagnostic delays, and referral pathways. Researchers will measure the accuracy and reliability of the new test compared to standard methods. The main outcome is the sensitivity and specificity of the Technochrom test for diagnosing HAE. The study will last up to 12 months for each participant, with no additional long-term follow-up.
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Healthy Volunteer
This research investigates the effects of an Aescin-based herbal extract called Reparil compared with Ibuprofen in managing symptoms after surgical removal of impacted lower wisdom teeth. The study focuses on people aged 18 to 40 who undergo this common oral surgery, aiming to find out if the herbal treatment offers pain relief and reduces swelling and limited mouth opening with fewer side effects than traditional nonsteroidal anti-inflammatory drugs (NSAIDs). Participants will be randomly assigned to receive either Reparil tablets containing 20 mg Aescin or 400 mg Ibuprofen tablets, each taken orally three times a day for five days after surgery. Both groups follow the same schedule, and a rescue pain medication is available if needed. Assessments will occur before surgery and on days 2 and 7 afterward to measure pain, facial swelling using 3D scanning, and mouth opening using a digital caliper. During the study, participants will have their pain levels, facial swelling, and jaw movement tracked at specific intervals. Researchers will record any adverse effects and analyze data to compare the treatments' impacts. The total involvement includes the surgery and follow-up visits on days 2 and 7, helping to evaluate the herbal extract as a potential alternative to Ibuprofen for managing post-surgical symptoms.
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Researchers are conducting a nationwide registry in Armenia to observe and track systemic autoimmune and autoinflammatory diseases. These diseases involve abnormal immune system activity causing widespread inflammation and organ damage, often influenced by genetics and environmental factors. The study aims to better understand disease progression, which is usually measured by specific activity scores, and to gather detailed epidemiological and clinical data, as current knowledge in Armenia is limited. The study involves usual medical care for patients diagnosed with these systemic diseases, alongside collecting additional blood and stool samples for biobanking. Data collected include clinical exams, lab results, current treatments, and disease-specific activity scores reported by both patients and physicians. This observational registry will continue for about five years, assessing disease manifestations and evolution under treatment. Participants will be regularly evaluated through clinical and laboratory assessments, with data recorded on disease activity and progression. The study monitors systemic symptoms and uses disease-specific scores to track changes over time. Researchers will identify rare clinical forms and prognostic factors. The registry includes informed consent procedures and follows patients longitudinally to improve understanding of these complex diseases and their management.
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Researchers are evaluating the use of portable dynamic digital radiography (DDR), a new advanced chest X-ray technology, in intensive care unit (ICU) patients. DDR captures dynamic images of lung motion, ventilation, and perfusion at a high frame rate, potentially providing more detailed and quantitative lung function information compared to traditional chest X-rays. This trial aims to test the feasibility and safety of portable DDR in the ICU and to compare its diagnostic value with current standard imaging methods. Participants will receive one to three sets of DDR scans, including 7-second breathing and breath-holding scans. These images will be compared to gold standard clinical exams such as chest X-rays, CT scans, or ventilation-perfusion (VQ) scans. The study will observe how DDR performs in diagnosing lung conditions like diaphragmatic dysfunction, pulmonary embolism, and pulmonary edema, alongside routine clinical imaging. Throughout the study, participants will undergo DDR imaging alongside their routine clinical imaging. Researchers will analyze these images to measure lung motion, diaphragmatic movement, and perfusion. The primary outcomes include assessing the precision of DDR in evaluating cardiopulmonary functions related to the diaphragm and lung motion as well as pulmonary blood flow, over a period of up to two months. The study will monitor safety and diagnostic accuracy while patients receive standard care.
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Angioedema is a condition involving swelling that lasts 1 to 5 days and affects the skin under the surface or the digestive and throat areas. This swelling can be dangerous if it occurs in the throat, potentially causing difficulty breathing. Some angioedema cases are allergic and occur with hives, while others are non-allergic without hives and may be hereditary or acquired. Because these types of angioedema are rare, this registry aims to collect data from many patients with recurring angioedema without hives in one place for better understanding. The study is an observational registry coordinated by the Grenoble center, which works with associated centers across France. These centers collect and enter patient information into an electronic system and help patients use a mobile app to track their angioedema episodes. The registry includes different types of angioedema, such as hereditary forms with or without C1 inhibitor deficiency, acquired angioedema, drug-induced angioedema, and mast cell induced angioedema. The coordinating center organizes scientific meetings and manages data requests. Participants provide data over a five-year period, including demographic details, clinical features, coexisting conditions, angioedema diagnosis, duration and severity of attacks, and treatments used during attacks and for prevention. Investigators validate patient-reported episodes through electronic diaries. The registry monitors this information regularly, with associated centers updating the coordinator twice a year on patient enrollments and data quality. This long-term data helps researchers better characterize isolated angioedema cases.
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Healthy Volunteer
Researchers are evaluating how piezoelectric surgery compares with the traditional surgical method for removing lower third molars in patients aged 14 to 24. The study focuses on the effects of these two techniques on soft tissue swelling after the procedure. Facial swelling after surgery will be measured using a photogrammetry facial scanner to assess differences in recovery. Participants will undergo bilateral germectomy of the lower third molars using either the piezoelectric technique or the traditional surgical method. These two approaches are compared to see how they affect postoperative swelling. The study uses a randomized design with triple masking to assign participants to one of these two surgical methods. During the study, facial swelling will be measured before surgery and then again at 2 and 7 days after surgery using qualitative and quantitative analyses, including volumetric and linear measurements. Secondary outcomes include assessing jaw movement limitations (trismus) and pain levels with a visual analogue scale over the same time points. Participants are followed for a short period post-surgery to monitor these outcomes.
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Researchers are evaluating the effects of two corticosteroids, dexamethasone and methylprednisolone, on reducing postoperative pain, swelling, and limited mouth opening (trismus) in patients with isolated mandibular parasymphysis fractures. This clinical trial addresses the current uncertainty about which steroid is more effective for managing these postoperative complications. The study aims to provide clear evidence to guide clinicians in choosing the best steroid treatment to improve patient recovery after surgery. The trial compares two groups: one receiving a single submucosal dose of dexamethasone (8 mg) and the other receiving a single submucosal dose of methylprednisolone (40 mg). Both drugs are administered at the surgical site 30 minutes before the incision during open reduction and internal fixation surgery. The study uses a double-blind, randomized design to fairly assess the outcomes of both treatments. Participants will be monitored for facial swelling and pain intensity at baseline, 24 hours, and 72 hours after surgery. Blood samples will be taken to measure serum C-reactive protein, an objective marker of inflammation, at the same time points. Researchers will also track the use of additional pain medication and any side effects. This thorough assessment combining clinical signs and lab tests will help determine which steroid provides better postoperative control of symptoms. The study will continue until late 2026, ensuring comprehensive follow-up.
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Researchers are evaluating the effects of intravenous corticosteroids on laryngeal swelling and swallowing function in survivors of acute respiratory failure (ARF) who have documented laryngeal edema after being on mechanical ventilation. This randomized, placebo-controlled, double-blind trial is conducted across several major medical centers and enrolls patients from an existing longitudinal study who show laryngeal edema on fiberoptic endoscopic swallowing evaluation. The goal is to see if steroids can reduce swelling and improve swallowing quality of life after hospital discharge. Participants are randomly assigned to receive either 50 mg of methylprednisolone intravenously every six hours for four doses (total 200 mg) or a matching saline placebo on the same schedule. The study includes about 80 participants across five sites, with equal numbers in each group. The primary treatment period covers the first five days, during which swallowing function and laryngeal edema are closely monitored using the Revised Patterson Edema Scale and the Penetration-Aspiration Scale. During the study, participants undergo repeated fiberoptic endoscopic evaluations of swallowing to assess changes in laryngeal edema and swallowing safety from day 1 through day 5. Researchers will also measure quality of life related to swallowing and dietary habits one month after hospital discharge. Safety is monitored throughout, and all patients continue usual care. The total involvement includes the treatment period, follow-up assessments, and quality of life evaluations to understand the impact of corticosteroids on post-extubation dysphagia.
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