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Found 8 Actively Recruiting clinical trials
Actively Recruiting
Researchers are evaluating whether tucatinib combined with trastuzumab and mFOLFOX6 works better than the standard treatments for people with HER2 positive metastatic colorectal cancer, which is cancer that has spread or cannot be removed by surgery. This phase 3 study also aims to identify the side effects that may occur with this drug combination. Participants must have HER2 positive disease confirmed by testing and measurable cancer according to specific criteria. Participants will be randomly assigned to one of two groups. One group will receive tucatinib taken orally twice daily along with intravenous trastuzumab and the mFOLFOX6 chemotherapy regimen, which includes oxaliplatin, leucovorin or levoleucovorin, and fluorouracil given by IV every two weeks. The other group will receive standard care, which could be mFOLFOX6 alone or combined with either bevacizumab or cetuximab, both given by IV on specific schedules. Treatment continues as per the study protocol. During the study, participants will be monitored for progression-free survival up to about three years using imaging reviewed by independent experts. Researchers will assess side effects and disease response. Participants must be able to provide tumor tissue samples for testing and have a good performance status. The study includes brain imaging to check for metastases and monitors safety closely throughout the treatment period.
Actively Recruiting
Researchers are evaluating treatments for patients with clinically node positive breast cancer who undergo upfront surgery. The study aims to compare tailored axillary surgery (TAS) combined with axillary radiotherapy (ART) against the standard axillary lymph node dissection (ALND) to see which approach results in better arm-related quality of life and fewer cases of lymphedema two years after treatment. This trial addresses the concern that ALND, while standard, can cause significant harm and morbidity, and seeks to determine if TAS plus ART can reduce this burden. Participants are randomly assigned to receive either ALND, which involves surgical removal of lymphatic tissue in the armpit area, or the combination of TAS and ART. TAS targets positive lymph nodes more selectively than ALND and removes fewer nodes, while ART involves radiation treatment to the axillary region. The trial is conducted in the upfront surgery setting, with prior clipping of the most suspicious axillary lymph node to aid in treatment precision. During the study, participants will complete quality of life questionnaires and be closely monitored for the development of lymphedema over two years following randomization. The main outcomes measured are changes in arm-related quality of life and the occurrence of lymphedema. Safety and treatment effects will be tracked through regular follow-up visits, with the overall goal of improving patient well-being and reducing treatment-related side effects.
Actively Recruiting
This research investigates the functional changes in the stomach and esophagus in adults aged 18 to 65 years who undergo One Anastomosis Gastric Bypass (OAGB) surgery. The study focuses on patients with morbid obesity, gastroesophageal reflux disease (GERD), or gastric ulcers and aims to evaluate factors influencing marginal ulcer development over 2 and 5 years after surgery. These factors include age, gender, tobacco and alcohol use, medication use such as NSAIDs and immunosuppressives, Helicobacter pylori infection, and other medical conditions like diabetes and coronary artery disease. Participants receive the OAGB procedure performed laparoscopically. During surgery, the stomach is divided using a stapler alongside a tube placed by the anesthetist, creating a gastric tube connected to the small bowel approximately 200 cm from the ligament of Treitz. This connection is made using staplers to form an anastomosis between the stomach and small bowel. The procedure is designed to study the functional outcomes after this specific type of gastric bypass surgery. Throughout the study, participants are monitored for up to 5 years post-surgery. Researchers track rates of marginal ulcers at 2 and 5 years and assess various risk factors for ulcer development. Evaluations include clinical assessments and possibly imaging or other tests to monitor stomach and esophagus function. The study aims to provide detailed information on long-term outcomes and safety after OAGB surgery.
Actively Recruiting
Researchers are studying patients who have undergone or are scheduled for laparoscopic partial fundoplication surgery to treat gastro-oesophageal reflux and related esophageal motility disorders. The study focuses on patients with ineffective esophageal motility (IEM) before surgery, hypothesizing that reflux causes these motility problems. The goal is to see if esophageal motility improves or changes 18 to 24 months after surgery by comparing preoperative and postoperative results. Participants undergo partial fundoplication, either a 180° anterior or 270° posterior wrap, performed at one medical center. If a patient has preoperative IEM, they are invited to undergo high-resolution manometry 18 to 24 months after surgery. This outpatient test uses a thin catheter inserted through the nose to measure esophageal pressure during swallowing, providing detailed motility information. The Gastrointestinal Symptom Rating Scale (GSRS) is also assessed before and after surgery as part of routine care. Patients who agree to participate come to the study site for the manometry test approximately 1 to 2 years after surgery. Researchers measure the incidence of persistent ineffective esophageal motility after the operation. They also observe any new or ongoing motility disorders and compare symptom scores from the GSRS questionnaire before and after surgery to evaluate changes in gastrointestinal symptoms and esophageal function over time.
Actively Recruiting
Researchers are evaluating the impact of the StOP?-protocol, a structured communication briefing used during surgical operations, on post-operative mortality and other important patient outcomes. This study is a randomized controlled trial involving board-certified surgeons specialized in various surgical disciplines. The study aims to compare patient outcomes between surgeons trained to use the StOP?-protocol and those who continue their usual communication practices during operations. The StOP?-protocol is a behavioral intervention initiated by the lead surgeon during surgery. The surgeon informs the team about the current status of the operation, the objectives for the next steps, and any potential problems that might arise. The surgeon also encourages the team to ask questions or express concerns. Surgeons in the intervention group receive training on performing this protocol, while surgeons in the control group communicate as they normally would. The protocol is announced during the team timeout, and its implementation is monitored throughout the surgery. Patients operated on by the participating surgeons during the study period are involved in the trial. Researchers collect healthcare-related data with patient consent or under applicable Swiss law if consent documents are unavailable. The main outcome measured is mortality within 30 days after surgery. The study excludes patients under 18 years, those undergoing certain procedures outside the operating room, and patients with recent prior operations at the same site. Safety and patient outcomes are tracked through postoperative data collection and analysis.
Actively Recruiting
Gastroentero-pancreatic neuroendocrine tumors (GEP-NETs) are rare tumors that arise from the neuroendocrine system in the gastrointestinal tract and pancreas. This registry study aims to better understand these tumors by collecting detailed clinical information from patients diagnosed with GEP-NETs in Switzerland. Since limited knowledge exists about the biology and treatment of these tumors, the study focuses on gathering data to improve understanding and management strategies. Patients with a confirmed diagnosis of neuroendocrine tumors from any location who agree to participate will have their information entered prospectively into a secure, anonymized database. Data collection involves visits from study nurses to healthcare centers, where patient files are reviewed and information is recorded. There are no specific treatments assigned by this registry; instead, it tracks various treatment approaches used in Switzerland. Participants contribute data that includes tumor types, treatments received, and outcomes such as mortality and hospitalization rates. The study reviews and evaluates this information regularly to identify patterns and assess patient outcomes over time. The main outcome measured is tumor-related mortality every five years, helping to monitor long-term effects. This registry allows for improved knowledge sharing across hospitals and practitioners in Switzerland to enhance care for patients with neuroendocrine tumors.
Actively Recruiting
This research investigates how Esomeprazole, given either as 40mg tablets or dissolved in water, affects acid production in the gastric pouch of patients who have undergone Roux-en-Y gastric bypass surgery for obesity. The study aims to understand the drug's absorption by measuring its serum concentration and the pH levels inside the stomach pouch using a wireless monitoring system. The study is a Phase 4 pilot trial focusing on patients about one year after their surgery without reflux symptoms or ulcers. Participants undergo a routine upper endoscopy about one year after their surgery, during which a wireless BRAVO™ pH monitoring device is placed in the stomach pouch. The next day, participants are randomly assigned to receive Esomeprazole either as intact tablets or in solution form. Blood samples for serum Esomeprazole concentration are collected at 0, 60, and 120 minutes after dosing. pH monitoring continues for 48 hours while participants carry the wireless device. During the study, participants return the pH recorder after 48 hours, and any adverse events are checked before study completion. Researchers measure the intragastric pH to assess acid suppression and correlate it with the serum levels of Esomeprazole. The study also monitors safety and the participants' adherence to procedures, with a total participation period covering endoscopy placement, dosing, and 48 hours of pH monitoring.
Actively Recruiting
Researchers are investigating the differences in complications during and after thyroid removal surgery (thyroidectomy) in patients with thyroid overactivity caused by Graves' disease or Amiodarone-induced thyrotoxicosis (AIT). The study aims to determine whether patients undergoing surgery have similar complication rates depending on their thyroid hormone levels before or during the operation. This prospective observational trial uses data collected in the EUROCRINE registry to better understand risks and potentially improve treatment guidelines for these conditions. Participants will undergo thyroidectomy as part of their usual clinical care without changes to their treatment before or after surgery. Patients are grouped based on whether their thyroid hormone levels are controlled (normal) or uncontrolled (elevated) prior to surgery, assessed using free triiodothyronine (fT3) and free thyroxine (fT4) tests done within one week before the procedure. The study will include approximately 25 centers across Europe, with data collected securely online through the EUROCRINE registry and an add-on module for study-specific information. During the study, researchers will collect detailed information on surgical complications such as nerve injury, low calcium levels, bleeding, and severe heart events, along with surgery duration and hospital stay length. Data on preoperative medications and monitoring techniques will also be recorded. Participants will be followed for an average of two years after surgery to observe any complications. The findings aim to clarify if surgery can proceed safely without waiting for thyroid hormone levels to normalize, potentially reducing wait times and risks from prolonged hormone imbalance.