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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Accurate evaluation of axillary lymph nodes in breast cancer patients is crucial for understanding prognosis and planning treatment. This research focuses on improving the detection of lymph node involvement by combining clinical data, laboratory results, and multiparametric MRI images using an integrative multidata approach (IMA). The study also aims to monitor changes in lymph node status over time during neoadjuvant therapy, which is treatment given before surgery. The study is retrospective and observational, analyzing past data from breast cancer patients who had MRI scans and lymph node biopsies or surgeries. It compares the accuracy of detecting lymph node involvement using the combined IMA method against using MRI alone. The study includes patients across all genders and breast cancer stages I to III, especially those who received neoadjuvant therapy and have imaging data collected over time. Participants' MRI images, clinical details, and laboratory tests are reviewed to assess lymph node status. Researchers measure how well the IMA method detects lymph node metastases compared to MRI alone, with follow-up lasting up to two years. This study helps understand if integrating multiple types of data can better identify lymph node involvement and track treatment effects over time.
Actively Recruiting
Researchers are evaluating the effect of high-dose vitamin D3 on 28-day mortality in adult critically ill patients, focusing especially on those with severe vitamin D deficiency. Previous studies, including the VITdAL-ICU trial, showed no overall benefit for hospital length of stay but suggested a significant mortality reduction in patients with severe vitamin D deficiency. This phase III multicenter, placebo-controlled, double-blind randomized trial aims to confirm these findings in a larger group of critically ill adults. Participants will be randomly assigned to receive either a high dose of vitamin D3 or a placebo. The vitamin D3 group will receive a loading dose of 540,000 IU dissolved in 37.5 ml of medium chain triglycerides, followed by daily doses of 4000 IU (10 drops) for 90 days. The placebo group will receive an identical regimen without the vitamin D3. The study includes an interim analysis after half of the planned 1200 patients have completed 28 days. During the study, participants will be monitored for 28-day mortality as the primary outcome. The study will collect data on safety and health status over the 90-day treatment period. Researchers will track adherence to the daily dosing and monitor participants throughout their ICU stay and follow-up. This trial could provide important evidence about the use of vitamin D3 in severely deficient critically ill patients.
Actively Recruiting
Inflammatory Bowel Diseases (IBD), including Crohn's disease, ulcerative colitis, and unclassified forms, are often diagnosed in children and adolescents, with increasing cases in this age group. Various immunomodulatory treatments, especially biologic therapies targeting specific immune pathways, are used to manage IBD. While some biologics are approved for pediatric use, others are used off-label when treatments fail, highlighting the need for better understanding of these therapies in children. This research is a prospective, non-interventional study conducted at multiple pediatric gastroenterology centers in Austria, focusing on children under 18 receiving biologic treatments such as infliximab, adalimumab, vedolizumab, or ustekinumab. The study aims to monitor these therapies during both induction and maintenance phases over five years. No additional visits or interventions beyond routine clinical care are planned. Participants will undergo regular plasma level monitoring of their biologic therapy at baseline and approximately every few weeks up to week 54 during routine follow-ups. The study collects data from these assessments to understand how the drugs behave in the body and how well treatments work in pediatric patients. This approach supports dose adjustments and improved management of IBD in children without extra study-related procedures.