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Found 21 Actively Recruiting clinical trials
Actively Recruiting
This research aims to investigate the frequency of Neuronal Ceroid Lipofuscinosis Type 2 (CLN2) in children aged 2 to 6 who exhibit nonspecific neurological symptoms such as idiopathic seizures, speech disorders, and motor dysfunctions. The study targets children without hypoxic ischemic encephalopathy, head trauma, or developmental brain anomalies who visit Pediatric Metabolism, Neurology, and Developmental Pediatrics clinics over a 12-month enrollment period. It is a multicenter, non-drug screening study designed to better understand CLN2 disease among this population. During the study, demographic data, medical and family history will be collected at the first visit. Assessments will include seizure frequency, cognitive and language development evaluations, physical exams focusing on muscle strength, gait, and coordination, as well as neurological tests such as EEG and MRI scans. Children showing specific neurological signs or imaging findings will have blood samples taken for Tripeptidyl Peptidase 1 enzyme measurement. Those with low enzyme activity will undergo genetic testing to investigate CLN2 disease. Participants will be monitored for disease frequency over one year. Researchers will measure clinical and demographic characteristics including speech impairment, motor symptoms, EEG responses, and brain imaging changes. Safety monitoring includes obtaining informed consent and following up on enzyme and genetic test results. Total participation spans from initial screening through diagnostic testing and data collection during the 12-month study period.
Actively Recruiting
Researchers are studying the safety and effectiveness of long-acting antibodies given alone or in combinations to adults with moderately to severely active ulcerative colitis (UC). This Phase 2, multicenter platform trial aims to find treatments that can improve symptoms and induce remission in people diagnosed with UC for at least 3 months. The study includes participants with active disease confirmed by endoscopy and histology and with moderate to severe symptoms based on a scoring system. The trial has two parts. Part A is an open-label phase testing three different monotherapy drugs to assess safety and initial effectiveness. Part B will be a randomized, placebo-controlled phase where participants receive one of six interventions (three monotherapies or three combinations) or placebo to compare outcomes. Treatments involve intravenous (IV) induction followed by subcutaneous (SC) maintenance dosing. Different treatment arms may start and finish at varying times during the study. Participants will undergo endoscopy and histology to confirm disease activity at screening, with regular monitoring throughout the study. Researchers will evaluate changes in disease severity using the Robarts Histopathology Index and measure the percentage of participants achieving clinical remission by Week 12. Safety and efficacy will be closely followed during and after treatment. The total study duration depends on treatment arm timelines and follow-up requirements.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of SAR441566 in adults with moderate to severe Crohn's Disease in this phase 2, multinational, randomized, double-blind, placebo-controlled study. The main goal is to compare different doses of SAR441566 against a placebo to see how well they work in treating Crohn's Disease. The study involves participants who have had a confirmed diagnosis of Crohn's Disease for at least three months and have shown moderate to severe symptoms. Participants will take either SAR441566 tablets or matching placebo tablets orally during the study. The study begins with a 4-week screening period, followed by a 52-week main treatment phase that includes 12 weeks of induction treatment and 40 weeks of maintenance treatment under double-blind conditions. After this, a 2-week follow-up is conducted for those not entering the long-term safety study. Eligible participants may join an open-label phase lasting up to 40 weeks, but the combined time in maintenance and open-label phases will not exceed 40 weeks. During the study, participants will undergo assessments including endoscopy to measure response at week 12. Researchers will monitor symptoms, stool frequency, and abdominal pain scores to evaluate treatment effects. Safety will be tracked throughout the study, including a follow-up after treatment ends. The total study duration for participants can be up to 59 weeks, with careful monitoring to ensure accurate evaluation of SAR441566's impact on Crohn's Disease.
Actively Recruiting
Researchers are evaluating the effects of felzartamab in adults with Immunoglobulin A nephropathy (IgAN), a kidney disease caused by the buildup of abnormal IgA antibodies in the kidneys. This buildup leads to inflammation and damage, causing protein to appear in the urine. The study aims to understand how felzartamab influences proteinuria and kidney function, while also assessing the safety and how the body processes this treatment. This is a Phase 3, randomized, double-blind, placebo-controlled study focusing on adults with IgAN. Participants will be randomly assigned to receive either felzartamab or a placebo through intravenous (IV) infusions. Neither the participants nor the researchers will know which treatment is given. The treatment period lasts 24 weeks followed by an 80-week follow-up period. In total, participants will attend 17 study visits over about 2 years to receive infusions and participate in study activities. During the study, participants will undergo assessments including urine tests to measure protein levels, kidney function evaluations, and safety monitoring. Researchers will track changes in proteinuria from the start of the study to Week 36 as the main outcome. Additional measurements will include kidney function, clinical endpoints, and the study of how felzartamab is processed by the body. Participant safety and long-term effects will be monitored throughout the study and follow-up periods.
Actively Recruiting
Researchers are evaluating the safety, tolerability, pharmacokinetics, and preliminary effectiveness of two different doses of golexanolone compared to a placebo in adults with Primary Biliary Cholangitis (PBC) who experience significant fatigue and cognitive symptoms. This phase 1b/2 randomized, double-blind, placebo-controlled study includes participants with non-cirrhotic or Child-Pugh class A cirrhotic PBC who are on stable standard of care medication. The study aims to understand the effects of golexanolone on health-related quality of life, including fatigue, daytime sleepiness, and cognitive function. Participants receive soft gelatin capsules of golexanolone or placebo taken orally twice a day. Part A of the study administers 40 mg of golexanolone twice daily for 5 days to assess safety, tolerability, and pharmacokinetics. Part B involves treatment with two dose levels of golexanolone or placebo twice daily for 28 days to evaluate safety, tolerability, and effects on quality of life and cognitive symptoms. Throughout the study, participants are monitored for adverse events from baseline to the end of each treatment period (5 days for part A and 28 days for part B). Researchers assess safety and tolerability, cognitive function, fatigue, daytime sleepiness, and overall treatment effects. Participants must provide informed consent and be able to participate in evaluations during the treatment periods.
Actively Recruiting
Researchers are evaluating diagnostic methods for adult patients suspected of having acute appendicitis who undergo surgery. This study aims to assess how well computed tomography (CT) reports and the Appendicitis Inflammatory Response (AIR) score identify true cases of appendicitis and reduce unnecessary surgeries. It also explores how diagnostic accuracy varies among different patient groups based on factors like age, sex, and surgical history. The main goal is to measure the rate of negative appendectomies, where surgery is performed but pathology does not confirm appendicitis. This is a single-center, prospective observational study involving adult patients who present to the emergency department with suspected appendicitis. Eligible patients are those aged 18 or older who have a CT scan consistent with acute appendicitis and then undergo appendectomy. No additional study treatments are given beyond routine clinical care. Clinical data, CT reports, the AIR score, intraoperative severity grading, and final pathology results are collected and analyzed to understand diagnostic accuracy and agreement between methods. Participants provide informed consent and undergo standard diagnostic and surgical care. Researchers collect clinical and demographic information, calculate the AIR score, and record CT and surgical findings. The study measures diagnostic agreement between CT reports and pathology results within 30 days. It also examines relationships among AIR scores, surgery severity grades, and pathology. Results will help understand how well current diagnostic tools perform and may guide future management of suspected appendicitis.
Actively Recruiting
Researchers are comparing the effects of two types of regional anesthesia—an interscalene block alone and a combination of interscalene block with superficial cervical plexus block—on brain oxygen levels, carotid artery diameter, blood flow during surgery, lab results, recovery, and pain after shoulder surgery. The study uses near-infrared spectroscopy (NIRS) to non-invasively measure brain oxygenation and ultrasound to assess carotid artery size. Participants receive sedation with midazolam before either the interscalene block alone or the combined block is performed under ultrasound guidance. Measurements of brain oxygen and carotid artery diameter are taken at multiple time points before, during, and after the procedures, including various intervals up to 60 minutes during surgery and 5 minutes postoperatively in a supine position. Sensory block quality is checked at 20 minutes, and the timing and need for pain medication after surgery are recorded. Throughout the study, participants undergo repeated assessments of brain oxygenation and carotid artery size, along with monitoring of clinical and laboratory parameters. The study tracks intraoperative hemodynamics and postoperative pain to evaluate the effects of the anesthesia techniques. The total participant age range is 18 to 65 years, and the study involves detailed monitoring before, during, and after the shoulder surgery.
Actively Recruiting
Researchers are studying patients with cystic lesions to better understand how odontogenic cysts form by analyzing biomarkers in cyst fluid. This observational study aims to clarify the underlying mechanisms of these cysts by measuring specific proteins associated with cyst pathology. The study will include about 25 patients who visit Harran University Oral and Maxillofacial Surgery between August and December 2025. Participants will undergo routine procedures, including cyst fluid aspiration before cyst removal surgeries like enucleation or marsupialization. The fluid collected will be processed by centrifugation and stored at very low temperatures until analysis. The study will measure levels of MMP-8, MMP-9, RANKL, and MIP-1alpha in the cyst fluid using ELISA kits according to manufacturer instructions. During the study, researchers will analyze the biomarker levels in relation to cyst types and their clinical features. Statistical methods will assess data distribution and correlations between markers by cyst type. The main outcomes are the concentrations of MMP-8, MMP-9, RANKL, and MIP-1alpha in cyst fluid over approximately six months of study completion.
Actively Recruiting
Healthy Volunteer
Obesity is a widespread health issue that can cause serious complications. Bariatric surgery is considered an effective treatment to achieve long-term weight loss and improve health in overweight or obese individuals. This research focuses on evaluating the Duke Activity Index (DAI), a scale developed at Duke University Medical Center to measure daily living activities and physical functioning, to see if it can effectively assess physical activity levels in patients preparing for bariatric surgery. All participants in the study will be observed and assessed using the Duke Activity Index without additional interventions. The study aims to test the reliability and usefulness of the DAI in tracking physical activity before surgery, which may help guide rehabilitation after bariatric surgery. Participants will be evaluated on their physical activity levels using the Duke Activity Index at baseline and one day before surgery. Researchers will consider participants' ability to perform tests and monitor their physical functioning. The study focuses on adults with obesity who are candidates for bariatric surgery, tracking their activity status to better understand and support recovery and rehabilitation processes.
Actively Recruiting
Dysphagia is a swallowing disorder that can occur after a stroke, affecting the safe transfer of food from the mouth to the stomach. It is common in post-stroke patients and can lead to serious complications like aspiration pneumonia, malnutrition, and dehydration. To help manage this condition, compensatory techniques such as chin tuck and head flexion are used to improve swallowing safety. Kinesio taping (KT), which stimulates nerves and muscles, has recently been explored as a new method to support swallowing rehabilitation, particularly by targeting the suprahyoid muscles responsible for lifting the throat during swallowing. In this study, Kinesio tape will be applied over the suprahyoid muscle area to encourage muscle activation and potentially improve swallowing safety. The tape application focuses on enhancing the strength and movement of muscles involved in swallowing. This intervention is assessed immediately before and after taping to observe its effect on swallowing safety, measured by a scale that evaluates the risk of food entering the lungs. Participants will undergo assessments of their swallowing safety before and immediately after the Kinesio taping. Researchers will monitor changes using a specific scoring system for swallowing safety. The study includes adults over 18 years old who have had a stroke and experience swallowing difficulties. The total involvement includes consenting to participate and undergoing the taping procedure and swallowing evaluations to determine the potential benefits of this intervention.
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