Clinical Research Directory

Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have colorectal cancer that has spread to other parts of your body. * Be in good enough health to receive study treatment. * Should not be pregnant before starting treatment. Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects. The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment. * The study is expected to last approximately 33 months for each participant. * Participants will have regular visits to the study site for treatment, health checks, and tests. * After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects. * Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.

Implementation of a Pediatric ERAS-based Protocol in Intestinal Resection With Primary Anastomosis

Enhanced Recovery After Surgery (ERAS) is a multimodal perioperative care strategy designed to reduce surgical stress, decrease postoperative complications, and accelerate recovery after surgery. Although ERAS protocols are widely implemented in adult surgery, their application in pediatric surgery remains limited, and standardized perioperative guidelines for children undergoing intestinal surgery have not yet been fully established. This multicenter prospective study aims to evaluate the feasibility, safety, and clinical outcomes of implementing a standardized pediatric ERAS-based protocol in children undergoing elective intestinal resection with primary anastomosis. The study will be conducted in nine tertiary pediatric surgery centers in Poland. A total of 60 pediatric patients will be prospectively enrolled and managed according to the ERAS protocol. Outcomes in this cohort will be compared with a historical control group consisting of patients who underwent similar procedures before ERAS implementation. The primary research question is whether implementation of an ERAS protocol in pediatric intestinal surgery is safe and feasible and whether it improves postoperative recovery compared with conventional perioperative care. The study will evaluate perioperative outcomes including postoperative complications, length of hospital stay, tolerance of early oral feeding, and postoperative pain control.

Post-Market Study of the Signia Circular Stapler With Tri-Staple Technology in Left-sided Colon, Sigmoid, and Rectal Resections

The purpose of this study is to evaluate the safety and performance of the Signia™ power handle, Signia™ circular adapter, and Signia™ Tri-Staple™ 2.0 circular reloads (hereafter referred to as Signia™ circular stapler) in patients undergoing left sided colon, sigmoid, or rectal resections in a post market setting.

Long-term Health Outcomes of Screen Detected and Potential Celiac Disease Patients

The primary aim of this project is to investigate how active screening and the timing of diagnosis affect the long-term health outcomes of patients with celiac disease. Additionally, the study seeks to clarify the natural course of so-called potential celiac disease. A key focus is also placed on assessing adherence to a gluten-free diet among screen-detected and, if initiated, potential celiac disease patients, their satisfaction with the diagnosis, and the diet's impact on general health and quality of life.

Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?

This research project will assess how two treatments for irritable bowel syndrome (one dietary and one behavioral) work and for whom. This will be done by assessing moderators (what treatment works for who and in what context) and mediators (how treatment works). Investigators will also assess how the diet and behavioral treatments affect IBS symptoms during treatment. Participants will be randomized to either: i. A FODMAP diet online program that focuses on modifying the consumption of foods high or moderate in fermentable carbohydrates (FODMAPS) to manage IBS symptoms. or, ii. An Exposure-based Cognitive Behavioral Therapy (E-CBT) online program for IBS that focuses on changing symptom-related behaviors which are known to worsen IBS symptoms.

Spanish Series of Patients Treated With the Radionuclide Lutetium177

This study aims to pool the clinical experience of Spanish centers treating patients with 177Lu-DOTATATE to evaluate the efficacy, tolerance, and safety of the drug in routine clinical practice and to learn about the profiles of patients and tumors treated and the results in each type of patient and tumor.