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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are investigating a new method to improve the detection of lymph node involvement in patients with breast cancer. This retrospective observational study focuses on using an integrative multidata approach IMA, which combines clinical and laboratory data with multiparametric MRI images. The study aims to enhance accuracy over MRI alone and also monitor changes in lymph node status during neoadjuvant therapy. The study uses existing data from breast cancer patients who had MRI scans and axillary lymph node biopsies or surgeries. It includes patients of all genders and stages I-III who underwent neoadjuvant therapy and have longitudinal imaging data available. This approach allows researchers to assess lymph node metastases and track therapy effects over up to two years. Participants clinical characteristics, laboratory results, and MRI images are analyzed to compare the accuracy of lymph node involvement detection using the combined data versus MRI alone. The study also evaluates how lymph node changes relate to overall survival and progression-free survival. This long-term monitoring helps understand treatment impact and disease progression over two years.

Age: 18Years +All Genders
4 locations
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Actively Recruiting

Researchers are investigating the effect of high-dose vitamin D3 on mortality in adult critically ill patients, particularly those with severe vitamin D deficiency. Previous studies found no benefit in hospital length of stay but suggested a significant reduction in 28-day mortality in patients with very low vitamin D levels. This phase III randomized controlled trial aims to confirm these findings in a larger, multicenter setting. Participants will be randomly assigned to receive either a high dose of vitamin D3 or a placebo. The vitamin D3 group will get an oral loading dose of 540,000 IU dissolved in 37.5 ml of medium chain triglycerides MCT, followed by 4000 IU daily 10 drops for 90 days. The placebo group will receive an identical MCT loading dose and daily drops for the same duration. The study features a double-blind design and an interim analysis after half of the planned patients complete 28 days. During the study, participants will be monitored for 28-day mortality as the primary outcome. Secondary outcomes include hospital length of stay, hypercalcemia at day 5, and hospital readmissions within 90 days. The study involves regular assessments, safety monitoring by an independent board, and continued enrollment while interim analyses are conducted. Total participation spans at least 90 days with detailed follow-up.

Age: 18Years - 100YearsAll GendersPhase 3
18 locations
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Actively Recruiting

Inflammatory Bowel Diseases IBD, including Crohns disease, ulcerative colitis, and indeterminate colitis, are often diagnosed in children and young adults, with a rising number of cases in this age group. Various immunomodulatory treatments, especially biologic antibodies targeting specific immune pathways, are used to manage IBD. This research focuses on monitoring these biologic therapies in pediatric patients to better understand their behavior and how they relate to treatment responses. This observational study involves children under 18 with IBD who are treated with one of four biologic therapies infliximab, adalimumab, vedolizumab, or ustekinumab. Patients are grouped based on the biologic they receive during induction or maintenance treatment phases. The study collects data from routine clinical visits over five years without any extra interventions or visits required. Participants will be monitored at baseline and approximately at weeks 2, 6, 14, 22, 30, 38, 46, and 54 during their regular follow-up appointments. Researchers will measure drug levels in the blood, clinical disease activity scores, laboratory markers like calprotectin, and the development of antibodies against the biologics. The study aims to understand how these factors change over time and relate to treatment outcomes, using information gathered solely from standard care visits.

Age: 0Years - 18YearsAll Genders
10 locations