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Found 4 Actively Recruiting clinical trials
Actively Recruiting
Researchers are conducting a multicenter observational study to better understand the treatment outcomes for patients diagnosed with psoriasis by dermatologists in clinic settings across China. Psoriasis is a chronic, recurrent inflammatory disease influenced by genetic and environmental factors, presenting as erythematosquamous lesions and potentially affecting multiple organs. The study aims to compare the effectiveness of various treatments chosen by patients, including phototherapy, traditional systemic therapies, and biologics, in real-world clinical practice. This non-interventional study allows patients to select their preferred treatment without restrictions. Data is collected primarily through a phone application called "Psoriasis New World," enabling continuous monitoring of patient progress. The study evaluates multiple outcomes such as the Psoriasis Area and Severity Index (PASI), which measures skin lesion severity and body area involvement, along with the Physician Global Assessment, Investigator Global Assessment, Body Surface Area affected, and Dermatology Life Quality Index. Patient safety is monitored throughout, including the recording of any adverse events and laboratory tests such as liver function. Participants will be followed over six months to measure the percentage achieving complete clearance of psoriasis symptoms (PASI 100). Regular assessments of disease severity and quality of life changes will be conducted remotely via the app. Continuous safety monitoring ensures any side effects or complications are documented. This approach provides comprehensive real-world evidence on how different psoriasis treatments perform in routine clinical care.
Actively Recruiting
Enteral nutrition is the preferred method of nutritional support for children with gastrointestinal function, encompassing both oral and tube feeding approaches. Tube feeding involves delivering liquid food, water, and medications directly into the gastrointestinal tract through a feeding tube, making it a primary method of enteral nutrition. Compared to parenteral nutrition, enteral nutrition is more aligned with the body's physiological needs, helping to maintain the intestinal mucosal barrier, protect organ function, and regulate immune responses while being easier to initiate, cost-effective, and associated with a lower risk of infection. In 2009, the American Society for Parenteral and Enteral Nutrition (ASPEN) published guidelines for enteral nutrition practices, which were updated in 2017. ASPEN also launched the Verification of Enteral Tube Location Project (NOVEL) in 2019, providing clear protocols for the placement of nasogastric tubes in children. Additionally, the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition issued a position statement on nasoenteric feeding for children in 2019. In China, pediatric clinical nutrition has developed more slowly, but pediatric tube feeding has received growing attention in recent years. The Chinese Society of Parenteral and Enteral Nutrition published clinical application guidelines for pediatric enteral and parenteral nutrition support in 2010, followed by neonatal nutrition support guidelines in 2013. However, there have been no recent updates or standardized procedures for pediatric tube feeding. This study aims to synthesize the latest evidence on pediatric gastric tube placement and update healthcare professionals' knowledge in pediatric medical institutions, which also seeks to standardize tube placement techniques and apply best practices in clinical settings to enhance the safety and quality of care for children.
Actively Recruiting
Radiation-induced lung injury (RILI) is a common complication of chest radiotherapy occurring in up to 31.4% of cases, and it can worsen patient outcomes by disrupting treatment schedules. The increasing use of immune-checkpoint inhibitors (ICIs) alongside radiotherapy has raised concerns about added lung toxicity, including checkpoint-inhibitor-related pneumonitis (CIP), an immune-mediated lung injury that can necessitate stopping ICIs and threaten life. Both RILI and CIP present with similar symptoms such as fever, dry cough, chest tightness, and breathing difficulties, and are diagnosed through symptom assessment and imaging, primarily CT scans. Pulmonary function tests, especially measuring lung diffusion capacity (DLCO), help assess lung damage. Current treatments mainly involve corticosteroids with limited effectiveness, and the study explores pirfenidone, a drug with anti-inflammatory, antioxidant, and antifibrotic effects, as a potential therapy for RILI with or without CIP. This phase II/III trial includes a dose-finding phase II and a confirmatory phase III. In phase II, 90 participants with grade 2 or 3 RILI, with or without CIP, are randomly assigned to low-dose pirfenidone (400 mg three times daily), high-dose pirfenidone (600 mg three times daily), or placebo for 168 days, followed by safety follow-up and survival monitoring. Phase III will select the optimal dose based on phase II results and randomize eligible subjects 1:1 to that dose or placebo, with a similar treatment and follow-up schedule. After the post-treatment follow-up, phase III participants enter a long-term extension phase with survival assessments every three months. Participants will undergo screening up to 28 days before treatment, followed by 168 days of treatment observation, safety follow-up about one month after treatment, and ongoing monitoring for disease progression and survival. Researchers will assess changes in lung diffusion capacity (DLCO) at 24 weeks as the primary outcome. The trial will also monitor progression-free and overall survival, treatment safety, and tolerability. Participants must have stable medication doses if on treatment for lung injury and be capable of oral medication administration, with regular evaluations of lung function and health status throughout the study.
Actively Recruiting
Researchers are evaluating the efficacy and safety of TQC2731 injection in adults with severe asthma that is not well controlled. This is a Phase III, multicenter, randomized, double-blind, placebo-controlled trial involving 660 participants aged 18 to 75 years. The study focuses on those who have had asthma diagnosed for at least a year and have experienced multiple asthma exacerbations in the past year despite using high-dose inhaled corticosteroids and other asthma medications. Participants are randomly assigned in equal numbers to receive either TQC2731 injection at a dose of 420 mg every four weeks or a placebo injection with no active drug. Both treatments are given by subcutaneous injection. The study treatment lasts for 52 weeks, during which the effects of blocking the Thymic Stromal Lymphopoietin (TSLP) protein by TQC2731 are assessed. Throughout the study, participants will be monitored for asthma exacerbations and other health outcomes. Researchers will regularly evaluate safety and treatment effects over the full 52-week period. The primary outcome measured is the annual rate of asthma exacerbations from the first day of dosing through completion. Participants' medication use, symptom control, and adverse events will also be tracked to assess treatment impact and safety.