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Found 7 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating how well insulin icodec helps people with type 1 diabetes control their blood sugar levels. This study focuses on participants who have never used insulin icodec before and aims to observe their treatment experience over a period of about 22 to 30 weeks. The study is designed as a real-world, multi-center, prospective observational study to assess glycemic control, treatment satisfaction, and adherence. Participants will be treated with commercially available insulin icodec as prescribed by their doctors, following usual clinical practice. There is no randomization or placebo group; all participants receive insulin icodec. The treatment period lasts approximately 22 to 30 weeks, during which participants continue their daily basal and bolus insulin regimen prior to starting insulin icodec. During the study, participants will have their blood sugar control monitored, including measuring changes in glycated hemoglobin (HbA1c) from baseline to week 26. Researchers will also assess treatment satisfaction and adherence. Participants must provide consent and be available for study visits and data recording throughout the study duration.
Actively Recruiting
Researchers are evaluating how well the approved weekly injectable insulin icodec controls blood sugar levels compared to daily injectable basal insulins in adults with type 2 diabetes. This Phase 4 study focuses on people who need to start basal insulin treatment and have had type 2 diabetes for at least 180 days. The goal is to understand the effectiveness of once-weekly insulin icodec against standard daily basal insulins in real-world clinical practice over about 13 months. Participants will receive either insulin icodec once a week or one of the daily basal insulin analogues, such as insulin glargine, insulin detemir, or insulin degludec. Both treatments are given by subcutaneous injection. The choice between weekly or daily insulin is based on current treatment standards for type 2 diabetes. The study lasts approximately 52 weeks, during which participants maintain their assigned insulin regimen. During the study, researchers will monitor changes in participants' blood sugar control using the glycated hemoglobin (HbA1c) test from the start until week 52. Participants will have their HbA1c measured within 90 days before starting the treatment. Safety and any reactions to the insulin will also be tracked. The study aims to assess how well the weekly insulin icodec works compared to daily basal insulins in managing blood sugar over a year.
Actively Recruiting
Researchers are studying whether baricitinib can help preserve beta-cell function in children and adults newly diagnosed with type 1 diabetes. This Phase 3 trial focuses on participants aged 1 to less than 36 years who have recently been diagnosed with this condition. The goal is to understand if baricitinib, compared to a placebo, can maintain insulin-producing cell activity. Participants will be randomly assigned to receive either baricitinib or a placebo, both given orally. The study is double-blind, meaning neither participants nor researchers know who receives the active drug or placebo. Treatment and observation will continue for about 60 weeks. During the study, participants will undergo evaluations including measuring C-peptide levels to assess beta-cell function at the start and after 52 weeks. Researchers will monitor health status, collect laboratory tests, and track any side effects or changes in diabetes-related markers to determine the effects of baricitinib over the study period.
Actively Recruiting
Researchers are evaluating the safety and effectiveness of two different radiation treatments for patients with larger brain metastases measuring 2 to 4 cm. This Phase III, prospective, multicenter randomized trial compares fractionated stereotactic radiotherapy with single session radiosurgery to understand which approach offers better local control and fewer side effects. Patients with cerebral metastases from solid cancers are the focus of this study, which stratifies participants based on tumor volume and cancer histology. Participants will be randomly assigned to receive either fractionated stereotactic radiotherapy, given as 12 treatments of 4 Gy each with a 2 mm margin, or single session radiosurgery. Radiosurgery dosing depends on tumor size: 18 Gy for metastases 2-3 cm in size, or 15 Gy for those 3-4 cm, following RTOG 9005 guidelines. The study carefully monitors and compares these two radiation approaches to determine their impact on tumor control and side effects. During the study, participants will be followed for at least 12 months to measure the time to local progression of their brain metastases. Researchers will perform clinical evaluations, imaging scans such as contrast-enhanced MRI, and monitor side effects to assess treatment outcomes. The study ensures patient safety by excluding those with contraindications to MRI or prior overlapping radiation treatments. Overall, the trial aims to provide detailed information about treatment effectiveness and safety for patients with larger brain metastases.
Actively Recruiting
Researchers are collecting detailed data on patients undergoing partial nephrectomy, a surgery that removes part of the kidney to treat localized kidney tumors. This study aims to understand important factors that affect the quality of surgical care for patients with renal masses. The focus is on real-world outcomes related to different surgical approaches, including open and minimally-invasive methods like robotic surgery, which is becoming more common in Germany. Participants will be observed without additional intervention, as this is a registry study tracking patients receiving nephron-sparing surgery. Data collected includes patient details, tumor characteristics and complexity, the surgical approach used, complications during and after surgery, and kidney function. Follow-up will occur at 30 days, 12 months, 24 months, and 60 months to gather information on long-term kidney function, other health conditions, and survival. Throughout the study, researchers will collect questionnaires and clinical data to monitor complications, kidney filtration rate after surgery, and survival over five years. This data will help improve understanding of surgical care outcomes and guide optimal treatment for kidney tumors. Participants will be involved for up to 60 months, with regular assessments of their health and kidney function.
Actively Recruiting
Cholangiocarcinoma is a rare and aggressive bile duct cancer with limited treatment options and a poor outlook. This study investigates the use of ivosidenib, a targeted IDH1 inhibitor, which was approved in May 2023 by the European Medicines Agency for adults with locally advanced or metastatic cholangiocarcinoma carrying an IDH1 R132 mutation, who have already received at least one prior systemic therapy. The study aims to collect real-world data on the effectiveness, safety, and impact on quality of life of ivosidenib treatment. Ivosidenib will be given to patients according to the current prescribing information (SmPC). This is a prospective, multicenter, observational study conducted in Germany, enrolling a broad patient population receiving ivosidenib as part of routine care. Treatment is not assigned by the study but is observed in real-world settings, allowing for the collection of comprehensive data on this therapy. Participants will be monitored for up to 38 months to measure progression-free survival, among other outcomes. Data on quality of life and safety will also be collected. Patients will provide informed consent, and those opting into the patient-reported outcomes module will complete assessments in German. The study will provide valuable insights into how ivosidenib performs outside of clinical trials.
Actively Recruiting
Researchers are studying the use of venetoclax in people with chronic lymphocytic leukemia (CLL) to understand how effective it is and to assess the costs and patient-reported outcomes when used in real-life medical settings. The study looks at venetoclax given alone or combined with rituximab, obinutuzumab, ibrutinib, or acalabrutinib, based on doctors' decisions and local treatment guidelines. Participants receive venetoclax therapy as prescribed by their physician, which may include the drug alone or along with one of the mentioned combination treatments. The study follows patients in Austria, Germany, and Switzerland, observing how the treatments are used in everyday practice without altering the prescribed therapy. During the study, participants are monitored for up to 12 months to measure the percentage who achieve the best overall response rate (ORR) to treatment. Researchers also collect data on health economics and patient experiences to better understand the impact of these therapies in routine care.