Tokorozawa

Crohns disease is a chronic inflammatory condition affecting the digestive tract and is currently incurable. This research aims to evaluate how safe and effective the drug upadacitinib is for treating moderately to severely active Crohns disease in real-world settings. The study will monitor any adverse events and track changes in disease activity among participants. All participants will receive upadacitinib as prescribed by their own doctors according to approved local guidelines. The study plans to enroll about 240 participants in Japan who have recently started upadacitinib treatment. Treatment will follow routine clinical practice without altering the prescribed approach. Participants will be followed for up to 64 weeks with visits that may occur in person or virtually, aligned with standard care. Researchers will assess outcomes such as the percentage of participants experiencing serious infections related to the drug. There is expected to be no extra burden beyond usual medical care throughout the study period.

Researchers are evaluating the effects of vicadrostat combined with empagliflozin in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. The study aims to assess whether this combination can help reduce cardiovascular risks compared to a placebo with empagliflozin. This Phase III trial involves adults with these conditions who are already receiving treatment for them. Participants are randomly assigned to one of two groups. One group takes vicadrostat and empagliflozin tablets daily, while the other group takes placebo tablets that look like vicadrostat but have no active medicine, alongside empagliflozin. Treatment lasts from two and a half years up to four years and three months. All participants continue their usual medications for diabetes, blood pressure, and heart disease during the study. Throughout the study, lasting up to four years and three months, participants visit the study site regularly for health checks and blood samples. Doctors monitor cardiovascular events and any side effects experienced. The main outcome measured is the time until the first cardiovascular death or heart failure event. Other health indicators like blood pressure and kidney function are also tracked to understand the effects of the treatment combination.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

Researchers are evaluating the overall survival of patients with stage I epithelial ovarian cancer after they have undergone comprehensive staging surgery. This phase III trial compares the outcomes of adjuvant chemotherapy versus observation alone. The study aims to determine whether adding chemotherapy after surgery improves survival in this patient group. Participants will be randomly assigned to one of two groups. One group receives adjuvant chemotherapy, which includes either a combination of paclitaxel and carboplatin or docetaxel and carboplatin, given every three weeks for three to six cycles. Switching between paclitaxel and docetaxel is allowed if adverse events occur. The other group undergoes observation without chemotherapy. During the study, participants will be monitored for overall survival up to 60 months from randomization. Researchers will also assess relapse-free survival within the same timeframe. Evaluations include follow-ups to track disease progression, side effects, and general health. The study ensures participants receive appropriate care and measures outcomes to better understand treatment benefits and risks.

Researchers are evaluating treatments for patients with locally recurrent rectal cancer who have not received prior pelvic radiation. This randomized phase III trial compares the outcomes of two treatment approaches surgery plus adjuvant chemotherapy alone versus preoperative chemoradiotherapy followed by surgery plus adjuvant chemotherapy. The study aims to confirm whether adding preoperative chemoradiotherapy improves local relapse-free survival, with additional measures including overall survival, relapse rates, surgery success, and quality of life. Participants are randomly assigned to one of two groups. One group receives preoperative chemoradiotherapy using capecitabine and radiotherapy, followed by surgery and adjuvant chemotherapy, which may include CAPOX, mFOLFOX6, capecitabine, or 5-FU with leucovorin. The other group undergoes surgery followed by the same options for adjuvant chemotherapy. Surgical procedures are performed to achieve complete tumor removal, with timing depending on the assigned treatment arm. During the study, patients will be monitored at several points including before surgery, after surgery, and up to three years post-registration. Researchers will assess local relapse-free survival, overall survival, relapse-free survival, adverse events, and quality of life. Treatment completion rates and pathological responses to preoperative chemoradiotherapy will also be evaluated. The total duration of follow-up for participants extends through three years after registration to monitor long-term outcomes.