Gastroesophageal Reflux Disease (GERD)

Researchers are evaluating the long-term outcomes of stopping endoscopic surveillance in patients with low-risk non-dysplastic Barrett's esophagus (NDBE). This observational study aims to determine whether discontinuing surveillance leads to an increase in clinically significant esophageal adenocarcinoma (EAC), focusing on patients with Barrett's esophagus less than 5 cm in length, no history of dysplasia, and no family history of EAC. The study is a nationwide, prospective, single-arm project in the Netherlands with a minimum follow-up duration of 10 years. In this study, endoscopic surveillance is discontinued following new Dutch guideline recommendations for eligible low-risk NDBE patients. Participants are then monitored through existing national registries and medical records without additional procedures or interventions. Two patient groups will be analyzed separately: those with prior surveillance history and those newly diagnosed with NDBE at inclusion. Data collection involves pathology reports, national statistics, and cancer registries, with outcomes reviewed annually by a data safety monitoring board. Participants provide informed consent to be included in the registry, but no active involvement or changes to their care are required beyond standard practice. Researchers will track the incidence of clinically apparent EAC, defined by EAC-related death or EAC requiring palliative or non-curative treatments, over at least 10 years. Privacy protections and ethical standards are carefully maintained throughout the study to minimize risks and ensure confidentiality.

Gastroesophageal reflux disease (GERD) occurs when stomach acid flows back into the esophagus and throat, causing symptoms like heartburn, acid regurgitation, throat irritation, hoarseness, difficulty swallowing, and a dry cough. This condition may be caused by weak lower esophageal sphincter muscles, hiatal hernia, or movement disorders in the esophagus or stomach. Researchers are exploring whether voice samples can detect characteristic changes related to reflux, potentially offering a simple, non-invasive way to identify this condition early. This observational study involves patients undergoing standard diagnostic tests for reflux, including gastroscopy, esophageal manometry, and 24-hour impedance pH measurement. Participants will be grouped into those with confirmed reflux and those without. Voice recordings and questionnaires will be collected at diagnosis and, for reflux patients, again five months after starting treatment. The recordings will be digitally analyzed for typical vocal changes associated with reflux by a Swiss technology center. Participants will provide voice samples via microphone and complete questionnaires without needing extra hospital visits. The study lasts up to five months and stores data securely in encrypted form following strict privacy rules. Researchers aim to identify vocal markers linked to reflux and understand how they relate to symptoms and treatment effects, with results expected in 2025.

Researchers are evaluating a magnetic-assisted surgical technique for revisional bariatric surgery, specifically converting sleeve gastrectomy to Roux-en-Y gastric bypass (RYGB) combined with hiatoplasty. This approach addresses long-term problems such as gastroesophageal reflux disease (GERD) in patients who have undergone laparoscopic gastric sleeve (LGS) surgery. The study aims to assess the surgical procedure and its outcomes in patients who are candidates for bariatric surgery with obesity. The surgery is performed using magnetic assistance to improve visualization and manipulation during key steps. It involves placing a single port in the umbilicus and an additional trocar, using magnets for liver retraction, dividing the omentum, repairing hiatal hernia, creating the gastric pouch, measuring and connecting intestinal limbs, and closing defects. A methylene blue leak test is done to check for leaks, and the entire Roux-en-Y gastric bypass is completed with magnet-assisted maneuvers. Participants undergo this bariatric procedure with magnetic assistance and are monitored for complications within 30 days, device malfunction within 1-2 hours post-procedure, and surgical time within 30 days. The study includes evaluations of surgical field exposure, anastomosis construction, and hernia repair. The total participation timeline includes the surgical procedure and follow-up assessments up to 30 days after surgery.

Researchers are evaluating PepZinGI45, a zinc-L-carnosine dietary supplement, to see if it reduces food-triggered heartburn compared with placebo. This randomized, double-blind, placebo-controlled crossover study includes adults with self-reported food-triggered heartburn occurring at least once per week. The study also examines sleep outcomes related to heartburn, using various questionnaires and wearable device metrics. Participants take PepZinGI and a placebo each for one week, separated by a two-week washout period, totaling 29 days. During each treatment week, participants consume a hurdle meal designed to trigger heartburn. The study is fully remote with no in-person visits, and all activities are completed through the Alethios platform. Throughout the study, participants complete electronic surveys on heartburn severity and frequency and sleep quality at baseline, day 8, and day 29. Wearable devices track sleep duration, quality, resting heart rate, heart rate variability, and restlessness continuously from baseline through day 29. Participant satisfaction is also assessed with questionnaires after each treatment phase. Rescue medication use and timing of symptom relief are recorded, ensuring comprehensive monitoring of heartburn and related sleep outcomes.

Researchers are developing and validating a wearable sensor designed to help patients with Parkinson's Disease (PD) who have swallowing difficulties and drooling problems. This study focuses on improving the device's battery life and size, assessing usability with patient feedback, and testing its ability to detect and encourage swallowing in PD patients. The aim is to provide a digital therapeutic platform that can support swallowing function in this population. The wearable device, called the Aria sensor, is a patch that monitors physiological signals continuously and provides vibratory haptic cues to increase how often participants swallow. Participants will use the sensor for three weeks, with the device actively providing haptic cues only during the second week. This single-arm study tracks how the sensor performs in real-life conditions without randomization or blinding. Participants will be involved for three weeks, during which researchers will measure swallow frequency changes, participant adherence to using the haptic cues, and changes in clinical scales related to drooling and swallowing. Assessments include comparing sensor data to a gold standard and evaluating symptom severity before and after the intervention. The study also includes focus groups to gather patient feedback on usability, and safety monitoring is conducted throughout the study period.

Researchers are evaluating DA-3501, an investigational drug, in patients with advanced gastric or gastro-esophageal junction adenocarcinoma and advanced pancreatic ductal adenocarcinoma that express the CLDN18.2 protein. This first-in-human phase I/IIa study aims to find the maximum tolerated dose (MTD) or optimal biological effective dose (OBED) of DA-3501 when given every three weeks, to determine the best recommended dose for further studies. Participants will receive DA-3501 intravenously once every three weeks at assigned dose levels. The study includes multiple dose levels, starting from dose level 1, to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy. Tumor assessments and various safety and laboratory tests will be performed according to the study schedule. During the study, participants will undergo tumor evaluations using standardized criteria, safety monitoring including dose-limiting toxicities during the first 21-day cycle, pharmacokinetic and immunogenicity testing, and overall response rate assessments. The study duration depends on treatment cycles and ongoing assessments. Safety and disease status will be monitored throughout, with follow-up continuing as per protocol until study end in February 2029.

Researchers are investigating the development of high-grade dysplasia (HGD) and esophageal adenocarcinoma (EAC) in patients with Barrett's Esophagus (BE). This study compares the traditional random biopsy method with a new Wide-Area Transepithelial Brush-Sampling (WATS) technique to improve detection during surveillance. The study focuses on two groups: those at high risk after removal of visible lesions or low-grade dysplasia and those under routine BE surveillance without dysplasia. Participants will undergo baseline and follow-up endoscopies over three years where both random biopsies and WATS brushings are performed. The WATS brush samples cells from all epithelial layers using a specialized cytology brush passed through the endoscope. This method is being studied for its potential to detect dysplasia earlier and more thoroughly than traditional biopsies. Samples collected will also support future biomarker research to better predict disease progression. During the study, participants will have regular endoscopic exams with combined biopsy and brush sampling to monitor for the appearance of HGD or EAC. Researchers will analyze biopsy results, WATS findings, and patient outcomes over the three-year follow-up. Safety and procedure effectiveness will be assessed, and the study allows for specimen collection to explore new diagnostic markers. The total participation duration is three years, with ongoing monitoring to understand the natural history of cases identified by WATS but not by biopsy.

Researchers are evaluating zanidatamab, an intravenous drug, for treating adults with previously treated solid tumors that show high levels of HER2 protein (IHC 3+). This phase 2, open-label study focuses on participants whose tumors have progressed after prior systemic treatments and aims to assess the drug's safety and effectiveness. The study excludes certain cancers like biliary tract cancer and considers participants with various solid tumors such as breast, gastric, lung, and colorectal cancers. Participants will receive zanidatamab through intravenous infusion, with treatment details tailored to their specific tumor type and prior therapy history. The study includes cohorts with different prior treatment backgrounds, including those who have received HER2-targeted therapies and those who have not. Tumor samples will be centrally tested to confirm HER2 overexpression, and participants must have measurable disease for assessment. During the study, participants will undergo regular evaluations including imaging scans assessed by independent review and investigators to measure tumor response using RECIST 1.1 criteria. Researchers will monitor safety through adverse event reporting and laboratory tests, track drug levels and immune response, and assess quality of life related to side effects. The study duration for outcome assessment is up to 2.5 years for most measures, with overall survival followed up to 3.5 years.

Researchers are evaluating a combined screening and follow-up management approach for gastrointestinal tumors. This study aims to explore and assess the feasibility and cost-effectiveness of screening for esophagus, stomach, and colorectal cancers in a population-based, multicenter setting. The trial includes participants aged 45 to 70 years and will observe outcomes over a 10-year follow-up period. Participants are divided into groups undergoing different screening methods. Group one receives gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori antigen test, RNF180 and SEPTIN9 gene methylation tests, along with an investigation of various risk factors such as past diseases, lifestyle habits, family cancer history, and reproductive status. Group two undergoes risk factor investigation, FIT, and Helicobacter pylori antigen stool test; if positive, further gene methylation tests and possibly colonoscopy are conducted. Control groups matched by spouse or sibling undergo only risk factor investigations. During the study, participants provide information on medical history, lifestyle habits, and family cancer history. Screening tests including endoscopies, stool tests, and gene methylation analyses are performed as specified. Researchers will monitor the detection of cancer or precancerous lesions over 10 years, tracking health outcomes and the effectiveness of combined screening. Safety and adherence are observed throughout the follow-up.

This observational study aims to evaluate the effectiveness of Danning Tablets in relieving dyspepsia symptoms in patients who experience digestive issues such as upper abdominal pain, bloating, loss of appetite, acid reflux, or constipation. It seeks to understand how factors like symptom severity, patient demographics, dosage, and treatment duration influence the tablets' impact. The study is sponsored by Shanghai Hutchison Pharmaceuticals Limited and focuses on patients already using Danning Tablets in their regular care. Participants in this study are adults aged 18 to 75 who are currently taking Danning Tablets for indigestion symptoms as part of their regular treatment. The study involves collecting questionnaire responses at two and four weeks after starting their treatment to assess changes in symptoms and quality of life. There is no control group since this is an observational study of patients already taking the medication. Throughout the study, participants will complete assessments measuring the rate of symptom improvement, including dyspepsia symptom relief, gastrointestinal symptom rating scales, abdominal pain ratings, and quality of life using the EQ-5D-5L questionnaire. Adverse events are also monitored during the two- and four-week periods. The main outcome is the responder rate for dyspepsia symptoms at four weeks after enrollment, with all participation lasting up to four weeks.