Polyarthritis Nodosa is a rare inflammatory disease affecting blood vessels and causing widespread damage in the body. Clinical trials in this area explore treatment evaluations to identify therapies that can control inflammation and manage symptoms ...
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Found 51 Actively Recruiting clinical trials
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Researchers are evaluating a new MRI pulse sequence called 3D DL oZTEo to detect bone erosions in the hands of patients with inflammatory arthritis. The study aims to validate this technique against current standard methods like radiography and conventional MRI, as these structural changes are important for diagnosis and treatment decisions in rheumatic conditions. This is an interventional study conducted at Mayo Clinic. Participants will have the FDA-approved oZTEo MRI pulse sequence added to their routine hand MRI scan. The oZTEo images will be anonymized and processed using a deep learning algorithm developed by GE Healthcare. This additional sequence is assessed alongside the standard MRI to compare its ability to detect bone erosions. During the study, researchers will analyze MRI scans with and without the 3D DL oZTEo sequence to determine the presence and number of bone erosions in the hand. Participants must have recent hand radiographs confirming erosions and are scheduled for hand MRI as part of their clinical care. The study measures outcomes on the day of imaging and monitors the accuracy of erosion detection.
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Researchers are studying the experiences of people who develop rheumatic immune-related adverse events (irAEs) after receiving immune checkpoint inhibitor immunotherapy. This study aims to understand how severe these events are, how they affect daily function, and the attitudes of patients towards different aspects of these side effects. The research focuses on conditions like arthritis and polymyalgia rheumatica that arise following this cancer treatment. This observational study does not involve any drug or treatment interventions. Instead, it gathers information through qualitative assessments from patients diagnosed by rheumatologists with inflammatory arthritis or polymyalgia rheumatica as irAEs after immune checkpoint inhibitor therapy. The study is sponsored by M.D. Anderson Cancer Center and will collect data over about one year. Participants will engage in interviews to share their experiences, which will help researchers evaluate the safety and adverse events associated with these immune-related conditions. The study includes monitoring adverse events throughout the study period. The total involvement duration averages one year, allowing for comprehensive understanding of the impact and progression of these rheumatic irAEs.
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Influenza infection poses a significant public health challenge due to seasonal outbreaks and pandemics causing widespread illness and death. This study focuses on hospitalized neonates and infants under 6 months of age with complicated influenza infection, a group with limited treatment options because their immune systems are immature and no licensed vaccines exist for this age. The study aims to evaluate the pharmacokinetics (PK), safety, and tolerability of intravenous (IV) zanamivir in this vulnerable population as part of a Pediatric Investigation Plan by GlaxoSmithKline. Participants who are hospitalized neonates and infants under 6 months, including preterm infants with at least 28 weeks post-menstrual age, will receive daily IV zanamivir infusions for up to 5 days. Depending on clinical symptoms, participant condition, or virological tests, this initial treatment may be extended for up to 5 additional days. The dosing is individually determined based on corrected age, body weight, and renal function, with the initial dose followed by twice-daily maintenance doses as guided by the principal investigator. Each participant will be involved in the study for up to 24 days, including a treatment period of up to 10 days and a 14-day post-treatment follow-up. Researchers will collect blood samples to measure zanamivir levels at various time points, monitor viral load changes, and assess safety by tracking adverse events and vital signs such as heart rate, oxygen saturation, respiration rate, and body temperature. The study also monitors for any emergence of resistance to zanamivir during the follow-up period to better understand treatment outcomes and safety in this young population.
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Researchers are evaluating the effectiveness of antigravity treadmill training and body weight-supported treadmill training for rehabilitation in elderly patients aged 60 to 75 years who have recently undergone hip or knee replacement surgery. The study compares these two methods to conventional gait training to see which approach may better support recovery and walking ability after surgery. Participants will be randomly assigned to one of three groups: antigravity treadmill training, body weight-supported treadmill training, or conventional rehabilitation. Each group will undergo a 6-week program with five sessions per week. The antigravity treadmill uses air pressure to reduce weight on joints with gradually decreasing support, while the body weight-supported treadmill uses a harness to partially offload weight with a steady level of support. The conventional group receives standard postoperative therapy including gait training and physical therapy techniques. During the study, participants will receive comprehensive daily therapy including kinesitherapy, ergotherapy, and individualized physical therapy procedures. Researchers will assess outcomes such as pain and function using the Western Ontario and McMaster Universities Osteoarthritis Index, balance, mental health, stress, and walking parameters both before and after the 6-week intervention. The total participation period includes baseline assessments and the 6-week therapy program under professional supervision.
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Healthy Volunteer
Researchers are evaluating the safety and effectiveness of the Aptis PRUJ prosthesis, a device designed to treat patients with disorders of the proximal radial ulna joint. This prospective, multi-center, single-arm clinical trial plans to enroll 84 patients with conditions such as arthritis, unstable radial head, and decreased motion in the affected joints. The study is conducted at 9 centers across the US to better understand outcomes for this patient population. Participants will receive the Aptis PRUJ prosthesis as the investigational treatment. The study includes an enrollment period of 12 months followed by a 24-month follow-up period, totaling approximately 36 months. During this time, patients will have annual visits until the last participant reaches 2 years after surgery, allowing for ongoing monitoring of the device's performance and safety. Throughout the trial, participants will undergo evaluations focusing on success at 24 months as the primary outcome. Additional assessments include effectiveness measures, radiographic imaging, and health economic evaluations at multiple time points: 6 weeks, 3 months, 6 months, 12 months, and 24 months. The study also tracks patient adherence to rehabilitation and follow-up visits to ensure comprehensive data collection over the course of the trial.
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Researchers are investigating the role of the central nervous system (CNS) in chronic musculoskeletal pain, which lasts longer than 12 weeks despite treatment. This study focuses on conditions like osteoarthritis, fibromyalgia, chronic low back pain, and inflammatory arthritis, where altered CNS pathways contribute to pain beyond muscle or joint damage. The goal is to improve diagnosis and treatment by using tools that assess CNS activity related to pain. The study evaluates the use of the Central Aspects of Pain (CAP) questionnaire combined with simpler pain sensitivity assessments to identify CNS involvement in chronic pain. Participants self-report their pain and diagnoses, and these tools are tested for their ability to predict pain levels at six and twelve weeks. The study also compares these simpler measures with laboratory pain sensitivity tests to better understand CNS contributions. Participants will complete the CAP questionnaire and various pain sensitivity assessments at the start, six weeks, and twelve weeks. Additional evaluations include sleep quality, anxiety and depression, neuropathic pain symptoms, fatigue, cognitive failures, and overall health surveys. Researchers will analyze these results to understand how CNS activity affects pain and patient outcomes. The study is observational, and participants are involved over a 12-week period with assessments at specified intervals.
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Healthy Volunteer
Researchers are studying how daily changes in mood, pain, and activity relate to acute and chronic pain using a smartphone app called SOMA. The study includes people with acute pain, chronic pain, and healthy controls. A smaller sub-study focuses on patients with chronic low back pain, failed back surgery syndrome, or fibromyalgia, using EEG testing to explore brain and behavior patterns that might predict treatment responses. Participants will use the SOMA app daily for four months to track their symptoms and activities. Those in the sub-study will also attend an in-person EEG session to perform specific tasks before starting app use. Data collected will help identify patterns linked to pain transition, recovery, or flare-ups. The study also monitors app engagement and symptom dynamics over up to 12 months. During the study, participants will report pain, mood, and activity daily through the app. Researchers will analyze these reports alongside baseline and follow-up EEG and behavioral tests. Outcomes include measuring the likelihood of acute pain becoming chronic and understanding mood and pain interactions. Participants' progress and app usage will be observed over time to assess feasibility and treatment effects.
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Healthy Volunteer
People with axial spondyloarthritis (axSpA) often experience intestinal inflammation and imbalances in their gut microbiome, similar to Crohn's-like inflammatory bowel disease. Researchers are investigating whether a Partial Enteral Nutrition (PEN) diet, which includes a liquid formula and some solid foods and is known to help induce remission in IBD, can affect the gut microbiome and intestinal inflammation in axSpA patients and whether these changes influence systemic inflammation. The study involves a 2-week course of the PEN diet, with an optional additional 2-week extension, in people with active axSpA. The diet provides 70% of calories from an enteral nutrition formula and 30% from a limited range of solid foods. A group of healthy volunteers will also follow the same diet to serve as controls. Participants will be monitored for changes in their stool butyrate levels after 2 weeks on the PEN diet, which is the primary outcome. The study includes assessments of gut and immune responses in both axSpA patients and healthy volunteers. Participants will need to provide informed consent and follow the dietary intervention during the study period, with monitoring for adherence and any effects.
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Camptodactyly-Arthropathy-Coxa Vara-Pericarditis (CACP) syndrome is a rare inherited disorder caused by mutations in the PRG4 gene. It is characterized by the combination of camptodactyly (bent fingers or toes), joint problems without inflammation, and deformity of the hip bone, sometimes also involving heart and lung issues. The syndrome shows variable symptoms and may be underdiagnosed due to its rarity and resemblance to juvenile arthritis. This European multicenter study aims to collect detailed clinical, genetic, and therapeutic data to better understand the disease's characteristics and progression in children diagnosed with CACP syndrome. Participants are children diagnosed with CACP syndrome confirmed by genetic testing who were diagnosed between 2005 and early 2026. The study involves regular clinical visits approximately every six months to monitor symptoms, joint function, and possible complications like pericarditis. Imaging and lab tests are done every 1 to 2 years or as needed. No specific drug treatment is available, and the study focuses on observing the disease course, treatment approaches, and genotype-phenotype relationships over a 10-year period. Throughout the study, researchers will collect epidemiological and clinical information, including disease incidence, geographic and ethnic distribution, symptom progression, and treatment outcomes. Patient disability, pain levels, and well-being will be tracked using questionnaires. The study will also document any misdiagnoses before confirmation of CACP. Monitoring adverse events related to treatments used will be included. This long-term observation will help improve understanding and management of CACP syndrome in affected children.
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Researchers are evaluating a new combined fatigue intervention (COMFI) for people with inflammatory arthritis (IA), including rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Fatigue is a common and severe problem in IA patients, affecting their quality of life and ability to work. This study aims to test if combining a cognitive behavioral approach and physical activity can reduce fatigue severity and impact in patients from Denmark and Sweden. The COMFI intervention is a 24-week outpatient program consisting of six group sessions based on cognitive behavioral approaches covering topics such as fatigue, physical activity, energy management, and peer support. A seventh booster group session is held at week 24, along with an optional individual session between weeks 6 and 9, and a support line available from weeks 13 to 23. Participants join groups of 8-10 people, with the intervention tested in four groups across two sites. Participants will complete patient-reported fatigue outcome measures at baseline, 3, 6, and 12 months, using questionnaires and databases. Physical activity and fitness will be measured at baseline and 6 months. Attendance and time use will be recorded by health professionals. The study also includes two focus group interviews for qualitative evaluation. Data confidentiality and ethical standards are maintained throughout the study, which will provide insights into the feasibility and meaningfulness of the intervention for IA patients.
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