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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating whether combining tucatinib with trastuzumab and mFOLFOX6 works better than standard treatments for people with HER2 positive colorectal cancer that has spread or cannot be removed by surgery. This Phase 3 study also aims to learn about the side effects that may occur when taking this combination of drugs. Participants have metastatic or unresectable colorectal cancer and are randomly assigned to different treatment groups. Participants are randomly placed in one of two study groups. One group receives tucatinib taken orally twice daily along with trastuzumab given intravenously every 3 weeks and mFOLFOX6 chemotherapy every 2 weeks. The other group receives standard care, which may be mFOLFOX6 alone or combined with bevacizumab or cetuximab, both given intravenously on different schedules. Tissue samples and biopsies are collected before treatment to confirm HER2 positivity and other markers. During the study, participants will have regular evaluations including imaging scans to measure cancer progression, blood tests, and assessments of side effects and quality of life. Progression-free survival is the primary outcome measured for up to about 3 years, with other outcomes like overall survival and response rate also tracked. Safety monitoring continues for about one year after the last treatment. The study lasts several years, with ongoing follow-up to understand long-term effects and benefits.
Actively Recruiting
Researchers are investigating whether tailored axillary surgery TAS combined with axillary radiotherapy ART is better than the current standard treatment, axillary lymph node dissection ALND, for patients with clinically node-positive breast cancer undergoing upfront surgery. The study aims to see if TAS plus ART improves arm-related quality of life and reduces the occurrence of lymphedema two years after treatment. This question arises because ALND, although standard, can cause significant side effects, and TAS selectively targets affected lymph nodes with potentially less harm. Participants will be randomly assigned to one of two groups one receiving ALND, which involves removing lymphatic tissue within the axilla, and the other receiving TAS with ART, where surgery removes sentinel and suspicious lymph nodes followed by targeted axillary radiotherapy. All participants will also receive breast or chest wall irradiation after breast-conserving surgery. The study compares these approaches to assess their impact on arm health and quality of life. During the trial, participants will be followed for at least two years to assess changes in arm-related quality of life and monitor for lymphedema. Researchers will collect quality of life questionnaires and clinical evaluations over this period. The study is sponsored by University Hospital Basel and aims to complete primary outcome assessments by the end of 2029, with overall study completion planned for 2037.
Actively Recruiting
Researchers are evaluating the functional changes in the stomach and esophagus of patients undergoing One Anastomosis Gastric Bypass OAGB. This study aims to assess various risk factors such as age, gender, tobacco and alcohol use, medications, and health conditions for the development of marginal ulcers after surgery, as well as other outcomes related to weight loss and gastrointestinal health. The research is sponsored by Spital Limmattal Schlieren and focuses on patients with obesity and related conditions like GERD and gastric ulcers. Participants will undergo the OAGB procedure performed laparoscopically. The surgery involves dividing the stomach and connecting it to the small bowel at a point about 200 cm from the ligament of Treitz. This creates a new pathway for food to bypass part of the stomach and small intestine. The study tracks patients after surgery to monitor changes and complications over time. Throughout the study, participants will be followed for up to 5 years post-surgery. Researchers will monitor marginal ulcer rates, weight loss percentages, changes in esophageal function, reflux events, and quality of life related to gastrointestinal and obesity issues. Assessments include endoscopy, manometry, impedance pH-metry, and questionnaires to evaluate reflux symptoms and life quality. Safety and long-term effects will be carefully observed to understand the impact of OAGB on stomach and esophagus function.
Actively Recruiting
This research evaluates esophageal motility changes in patients undergoing laparoscopic partial fundoplication 180 anterior or 270 posterior for gastroesophageal reflux disease GERD who have preoperative ineffective esophageal motility IEM. The study is combined retro- and prospective and focuses on whether postoperative motility decreases compared to preoperative levels, based on the hypothesis that motility disorders are caused by reflux. Participants who had or will have partial fundoplication between 2020 and 2023 are assessed for preoperative IEM. Those with IEM are invited to undergo high-resolution manometry 18 to 24 months after surgery to examine postoperative motility. The study also compares other motility disorders and evaluates gastrointestinal symptoms using the Gastrointestinal Symptom Rating Scale GSRS before and after surgery. During the study, participants provide consent and undergo high-resolution manometry, an outpatient diagnostic test where a thin catheter measures esophageal pressures during swallowing. The GSRS questionnaire is completed pre- and postoperatively as part of routine care. The primary outcome measures the persistence of IEM one to two years after surgery, with secondary outcomes including other motility disorders and symptom changes. The study duration extends through December 2027.
Actively Recruiting
Researchers are evaluating the impact of the StOP-protocol, a structured communication briefing used by surgeons during operations, on post-operative mortality and other important patient outcomes. This randomized controlled trial aims to compare patient outcomes between surgeons trained in the StOP-protocol and those who communicate as usual during surgery. The study focuses on improving communication in the operating room to potentially enhance patient safety and surgical results. Surgeons in the intervention group will receive multi-module training to perform the StOP-protocol during all their operations over a 4-month period. This briefing involves the surgeon informing the team about the current status of the operation, the goals for the next steps, and any potential problems, while encouraging questions or concerns from the team. Surgeons in the control group will continue their usual communication practices without this structured briefing. Participants include patients operated on by the cluster surgeons during the study period. Researchers will assess outcomes such as mortality within 30 days after surgery, unplanned reoperations, length of hospital stay, and unplanned hospital readmissions within 30 days. Patient data will be collected based on general consent or relevant legal provisions. The study will monitor these outcomes to evaluate the effects of implementing the StOP-protocol in surgical practice.
Actively Recruiting
Gastroentero-pancreatic neuroendocrine tumours GEP-NETs are rare cancers arising from the neuroendocrine cells in the gastrointestinal tract and pancreas. These tumours share common clinical features but their cell biology and mechanisms are not well understood, limiting targeted treatments. The SwissNET registry is designed to collect detailed information to better understand GEP-NETs and improve management strategies in Switzerland. This study collects data prospectively from patients diagnosed with neuroendocrine tumours confirmed by tissue analysis, regardless of the tumours original location. Data entry is anonymized and gathered from hospitals and general practitioners across Switzerland. A study nurse visits contributing centers to review patient files, and a review board addresses conflicting information. The registry monitors treatment approaches including surgery, medical therapy, and peptide-receptor radionuclide therapy. Participants provide informed consent for their data to be included. Researchers regularly evaluate patient outcomes such as tumour-related mortality and hospitalisation rates every five years. The registry also tracks the incidence of GEP-NETs in Switzerland and the effects of different treatments over time. This ongoing data collection aims to improve understanding and guide future care for patients with neuroendocrine tumours.
Actively Recruiting
This research aims to evaluate how esomeprazole, given either as a tablet or dissolved in water, affects acid production in the stomach pouch of patients who have undergone Roux-en-Y gastric bypass surgery for morbid obesity. The study focuses on measuring the acid level pH in the gastric pouch and the concentration of esomeprazole in the blood to understand absorption differences after this type of surgery. Participants will undergo a routine upper endoscopy about one year after their gastric bypass surgery. During this procedure, a wireless pH monitoring device is placed in the stomach pouch to continuously measure acid levels. The next day, participants are randomly assigned to receive a single dose of esomeprazole either as a tablet or as a solution dissolved in water. Blood samples are taken before and after dosing to measure esomeprazole levels, and pH monitoring continues for 48 hours. During the study, participants will be monitored for 48 hours with the wireless pH device recording stomach acidity. Blood samples will be collected at specified times to assess the drug concentration. After 48 hours, the pH device is removed, and any adverse effects are checked before the study ends. The primary measure is the pH level over 48 hours, with secondary focus on esomeprazole blood concentrations two hours after dosing. Participants typically complete the study within two days after the initial endoscopy.
Actively Recruiting
This research aims to understand how thyroidectomy removal of the thyroid gland complications may differ depending on the thyroid hormone levels before surgery in patients with Graves disease or Amiodarone-induced thyrotoxicosis AIT. It focuses on whether patients with different thyroid metabolic statescontrolled normal hormone levels or uncontrolled elevated hormone levelshave similar rates of complications such as nerve damage, hypoparathyroidism, bleeding, or severe heart events during and after surgery. The study is observational and uses data collected in the EUROCRINE registry from multiple centers in Europe. Patients who undergo thyroidectomy for Graves disease or AIT are grouped based on their hormone levels before surgery, using free triiodothyronine fT3 and free thyroxine fT4 tests taken within one week prior to surgery. The study does not alter the surgery or treatment methods. Data are collected prospectively through the EUROCRINE registry and an additional module for study-specific routine data. The study plans to include about 25 centers over two years and will record details such as surgery duration, blood loss, medications, monitoring techniques, hospital stay, and any complications. Participants will provide informed consent, and their usual surgical care is not changed. Researchers will track outcomes from the day of surgery through an average of two years, including complications and recovery. Data include clinical information, operative details, and postoperative follow-up. The study aims to help refine surgical guidelines and determine if waiting for normal thyroid levels before surgery is necessary, potentially speeding up treatment and reducing risks and costs for patients.