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NCT00260572
The aims of this study are to create a prospective data base to evaluate the long term outcomes of medical and surgical treatment of gastroesophageal reflux disease (GERD); to measure standard outcomes as well as patient derived outcomes such as general and disease specific quality of life (QOL) issues and patient satisfaction; to refine the parameters that may identify patients who will benefit from surgery for GERD; and to identify possible determinants of failure of both medical and surgical treatments of reflux.
NCT07518420
This study focuses on patients with NERD (gastroesophageal reflux disease) and liver-gallbladder disharmony syndrome as its research subjects. It conducts a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the Chai Zhi He Wei formula in terms of symptom improvement, quality of life, and adverse reactions. On one hand, this research aims to enhance the level of evidence-based medicine for TCM syndrome differentiation and treatment of NERD. On the other hand, it seeks to reduce the dosage of PPIs (proton pump inhibitors) or discontinue their use, addressing the side effects caused by PPI overuse, and serving as a leading example for TCM clinical research. Lastly, the study aims to optimize the efficacy of Tongjiang granules and address potential safety concerns, such as diarrhea.
NCT06585176
Gastroesophageal Reflux Disease (GERD) is a condition characterized by the reflux of gastric and duodenal contents into the esophagus, primarily manifested by symptoms such as acid regurgitation and heartburn. GERD significantly affects patients' daily lives and health-related quality of life. Prolonged gastroesophageal reflux can lead to repeated irritation of the esophageal mucosa by gastric acid and acidic gastric contents, resulting in the replacement of normal squamous epithelium in the lower esophagus with metaplastic columnar epithelium. This pathological change, known as Barrett's Esophagus (BE), is considered a precancerous lesion for esophageal adenocarcinoma.
NCT07344935
The Nissen Sleeve technique consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique), intends for decrease the rate of gastroesophageal reflux disease (GERD). This study aims to evaluate the influence of the Nissen Sleeve technique on GERD. However, the Ezisurg easyEndoTM Linear Cutting Stapler and Loading Units for Single Use were used in this study, and its safety and performance could be evaluated at the same time.
NCT02616302
Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach. The body uses stomach acid to break down food, but when acid rises up into the esophagus it can hurt or damage it. People with GERD often feel food coming back up into the throat and mouth and have a burning feeling in their stomach, chest, or throat, called heartburn. Other symptoms of GERD include pain in the stomach or throat, difficulty eating, and throwing up. Symptomatic nonerosive GERD is a condition where people have the symptoms of GERD but the esophagus has not been damaged. People of all ages can have GERD. The causes of GERD in children are similar to those in adults and teenagers. Dexlansoprazole is a medicine that has been shown to help relieve the symptoms of GERD in adults and teenagers. This study aims to find out if dexlansoprazole doses given to children with symptomatic nonerosive GERD, based on their body weight, helps them feel better.
NCT03853772
A multi-center, multi-year registry of patients with gastroesophageal reflux disease (GERD) undergoing diagnostic evaluation and/or treatment of GERD and associated diseases and complications.
NCT07251010
Introduction: The phrenoesophageal ligament (PEL) is a crucial structure that attaches the esophagus to the diaphragm, allowing for independent movement during respiration and swallowing. The ligament provides flexibility and strength, maintaining the integrity of the esophageal hiatus while accommodating pressure changes during breathing and swallowing. It consists of two limbs. The upper limb attaches the esophagus to the superior surface of the diaphragm, extending through the hiatus t'o insert into the esophagus 2-3 cm above it. The Lower Limb attaches the cardiac region of the stomach to the inferior surface of the diaphragm at the cardiac notch of the stomach. Failure and weakness of the PEL can predispose to esophageal HH and GERD symptoms. Understanding its anatomy is essential for the surgical management of hiatal hernia and GERD. Purpose: To investigate the effectiveness and safety of a new technique for hiatal hernia repair (Alinasser's Technique of LHHR) using a mesh fixed to both the esophagus and crura, mimicking PEL, with a focus on reducing recurrence rates and improving patient outcomes. Methods: A randomized controlled trial study will be followed. The study will include 60 HH patients who will be randomized into either the intervention group (30 patients) who will undergo the new approach, or the classic group (30 patients) who will undergo the classic approach. Patients in the intervention group will undergo cruroplasty using a new technique (mesh applied like PEL). Importance: A new surgical technique is being applied for management of HH to decrease postoperative recurrence
NCT06945237
Gastroesophageal reflux disease (GERD) is a common chronic digestive system disorder with a high prevalence and a notably increasing trend. It imposes significant costs in terms of treatment expenses and impacts patients' quality of life. Acid suppression remains the primary treatment for GERD. However, numerous clinical studies have shown that 20-30% of patients still exhibit poor response to proton pump inhibitors (PPIs) even after completing a standard course of acid-suppressive therapy. Many studies have demonstrated that the incidence of abnormal psychological conditions, such as anxiety, depression, and obsessive-compulsive disorder, is higher in GERD patients compared to the general population. Current international consensus acknowledges that the application of psychosomatic medicine principles and the use of neuromodulators can effectively alleviate symptoms in patients with gut-brain interaction disorders. Nevertheless, with the growing emphasis on digestive-psychosomatic-holistic medicine in clinical practice and the deepening of research on "gut-brain interactions," recent studies in the field of psycho-gastroenterology have challenged the notion that psychological processes are unique to gut-brain interaction disorders. Instead, these processes may play a universal role in symptom generation across the entire spectrum of GERD. Previous experiments have confirmed that Flupentixol-Melitracen (FM) can improve symptoms in GERD patients with a low incidence of adverse reactions. Therefore, we aim to verify the efficacy and safety of neuromodulators in patients with GERD, reduce healthcare costs, and provide new insights for optimizing treatment strategies for GERD patients in the future.
NCT05890001
The objective of this study is to evaluate the safety of up to 12 months (52 weeks) of once daily oral administration of BLI5100 in patients with non-erosive reflux disease (NERD) or healed erosive esophagitis (EE).
NCT07179250
The goal of this clinical trial is to evaluate whether two types of breathing training can improve symptoms of gastroesophageal reflux disease (GERD) in adults. The main research questions are: * Do volume-oriented incentive spirometry (VIS) or diaphragmatic breathing exercise (DBE) improve GERD symptoms compared with usual care? * Do these breathing exercises reduce the symptoms of GERD? * Does volume-oriented incentive spirometry (VIS) produce greater improvement in GERD symptoms compared with DBE? * Do these exercises increase the strength of the lower esophageal sphincter (LES)? Researchers will compare VIS training, DBE training, and usual care to determine whether breathing training can serve as a safe and effective non-pharmacological treatment option for GERD. Participants will: * Be randomly assigned to VIS training, DBE training, or usual care * Perform their assigned breathing training (if in the intervention group) twice daily for 6 weeks * Attend study visits at baseline and at week 7 for questionnaires and esophageal function tests * Keep a diary of their symptoms and breathing practice
NCT05678491
Gastroesophageal reflux disease (GERD) occurs when stomach acid repeatedly flows back into the tube connecting your mouth and stomach (esophagus). This backwash (acid reflux) can irritate the inner lining of the esophagus. This is a particular problem after surgery to reduce obesity called gastric sleeve resection. The goal of this small clinical trial is to examine the effect of endoscopic treatment of GERD by mucosal band ligation. The main questions it aims to answer are: * Does the treatment affect gastroesophageal reflux assessed by measuring gastroesophageal reflux * Does the treatment affect gastroesophageal reflux symptoms and ability to stop treatment with medication commonly used (proton pump inhibitors) Participants (n=12) will be asked to undergo 24 h reflux examination and report symptoms of GERD. Suitable patients will be offered endoscopic treatment with band ligation of the inner lining of the lower esophagus and upper part of the stomach. The effects will be assessed three and six months after the procedure.
NCT07174882
GERD is characterized by a high prevalence (about 13.3%) and is associated with a deterioration in the quality of life, as well as an increased risk of esophageal adenocarcinoma and a rise in the number of refractory cases. NERD is one of the forms of GERD, accounting for about 70% of all cases, and is characterized by symptoms that reduce the quality of life. Although proton pump inhibitors (PPIs) are the basic therapy for NERD, up to 40% of patients do not achieve an optimal clinical outcome. GERD symptoms seriously affect the quality of life and performance, which makes the study of complex therapy relevant. One of the mechanisms of GERD is a violation of the barrier function of the esophageal mucosa, associated with an increase in epithelial permeability due to the dysfunction of intercellular junction proteins, such as claudins and occludin. The study of methods to increase tissue resistance and cytoprotection, together with acid-suppressive therapy, is a promising direction, especially for refractory forms of NERD. It is relevant to study the complex treatment of NERD in order to change the clinical course of the disease and improve the tissue resistance of the esophageal mucosa. These hypotheses and theses emphasize the need for a comprehensive approach to the treatment of NERD and a research focus on improving the barrier functions of the esophagus
NCT07037875
The goal of this clinical trial is to find out how well linaprazan glurate can heal erosive esophagitis (EE) caused by gastroesophageal reflux disease (GERD), compared to lansoprazole, a commonly used medication. Researchers will also evaluate whether linaprazan glurate: * Reduces heartburn symptoms more effectively than lansoprazole * Is safe and well tolerated, based on physical exams, blood tests, and vital signs (heart rate, blood pressure, temperature, and breathing rate) * Causes any side effects during treatment * Has different effects depending on how much of the drug is in the blood * Works differently depending on participants' genes Participants must be between 18 to 80 years old and have EE due to GERD confirmed by an endoscopy. Participants cannot join if they have an active Helicobacter pylori (HP) infection or were treated for HP in the past 6 weeks or have taken antibiotics or bismuth-containing drugs in the past 6 weeks. The study is a randomized, double-blind, active comparator-controlled trial lasting up to 4 months. Randomized means that participants are assigned by chance (like flipping a coin) to one of the treatment groups and double-blind means neither the participants nor the study team will know which treatment is given. Participants will be placed into one of three groups (about 167 people in each group): * Linaprazan glurate 50 mg twice a day * Linaprazan glurate 50 mg once a day * Lansoprazole 30 mg once a day Everyone will take 2 tablets and 1 capsule by mouth daily for 8 weeks. Some tablets or capsules will be placebos (look like medicine but contain no active drug). Participants will: * Undergo an endoscopy in the beginning and after 4 weeks of treatment * If healing is not observed, another endoscopy may be done at 8 weeks * During the procedure, doctors will use a thin, flexible tube with a camera to look at the esophagus and take small tissue samples (biopsies) * Have blood and urine tests at clinic visits to check overall health * Receive electrocardiograms (ECGs) to monitor heart function * Complete daily questionnaires on an electronic device about symptoms and experiences
NCT07148492
To prevent refulx symptoms in a type of bariatric surgery, a suture is taken.there is no enough evidence in support of or against the suture. our study aims to compare the symptoms of patients in whom the suture is taken and in those in whom it is not.
NCT06812650
The aim of this study was to examine the effects of diaphragmatic breathing exercises combined with relaxation exercises on patient-reported reflux symptoms, quality of life, anxiety, and depression levels in patients diagnosed with gastroesophageal reflux.
NCT07115706
The purpose of this study is to evaluate the effectiveness and safety of JAQBO® Tab. 20 mg(Zastaprazan citrate) patients who have been prescribed the investigational drug.
NCT07121062
It's common for infants to be unsettled, especially in the first few months of life. While this is often normal, persistent symptoms can be stressful for families. Parents naturally seek explanations, and common suspected causes include colic, reflux, eczema, and cow's milk allergy (CMA). However, CMA is frequently over diagnosed, which can lead to unnecessary changes such as stopping breastfeeding or switching to expensive specialist formulas. To address this, we've developed an online questionnaire to help track and understand symptoms in unsettled infants. Our long-term goal is to use this tool to support more accurate diagnosis of CMA. Before that, we need to test and validate the questionnaire in a general population of infants, including those who are healthy and those with other temporary conditions like a recent immunisation or teething. This study involves an anonymous online survey for parents of babies under 12 months old. We aim to collect data from approximately 350 participants. The study will help us assess how well the questionnaire reflects the severity of symptoms and whether it can distinguish between healthy infants and those with underlying issues. Parents will be invited to take part using flyers with a QR code distributed in various healthcare settings, including GP clinics and children's clinics in hospital. The survey is anonymous and hosted on a secure platform. While we don't anticipate the questions to be distressing, we recognise some may touch on sensitive topics. Support resources and study team contact details will be provided. By validating this tool, we hope to improve how unsettled behaviour in infants is assessed-reducing unnecessary interventions and better supporting families and healthcare professionals.
NCT07041060
Background: Non-erosive reflux disease (NERD) is a prevalent subtype of gastroesophageal reflux disease (GERD), often inadequately managed with proton pump inhibitors (PPIs) alone. Eolo, a nutraceutical blend of sodium alginate, sodium bicarbonate, palmitoylethanolamide (PEA), and herbal extracts, has been proposed as an adjunctive therapy to enhance symptom relief and mucosal protection. Objective: This study evaluates the efficacy and safety of a nutraceutical \[Eolo®, Cristalfarma s.r.l. - Milan (IT)\] in combination with PPIs or alone compared to PPIs therapy in patients with NERD. Methods: A single-center, randomized, parallel-group study was conducted, enrolling 60 patients with NERD. Participants were randomized into three groups: (A) Eolo + half-dose PPIs for 12 weeks, (B) half-dose PPIs alone for 12 weeks, and (C) a control group receiving only half-dose PPIs for 24 weeks. After 12 weeks, groups A and B discontinued PPIs and continued with Eolo alone for an additional 12 weeks. Symptom relief and quality of life (QoL) were assessed using GERD-HRQOL and RSI questionnaires at baseline (T0), 12 weeks (T1), and 24 weeks (T2).
NCT06926374
Robotic assisted surgery has been performed for more than two decades with good success and safety profile. However, there was only one dominating robotic surgical system available in the past which led to high cost for robotic surgery. Recently, a new robotic surgical system (Sentire Robotic Surgical System) was introduced by researchers of The Chinese University of Hong Kong (CUHK). This new robotic surgical system aims to achieve similar outcomes and standards of robotic surgery performed using the dominating system but with a significantly lower cost. The technologic innovation and development of this new robotic system is made by the Cornerstone Robotics Limited, which is based in Hong Kong. In a pilot clinical study conducted at Prince of Wales Hospital involving 55 patients, the Sentire Robotic Surgical System had demonstrated high success rate with minimal complications in patients who underwent robotic colorectal, upper gastrointestinal, and urologic surgery. Researchers of CUHK would therefore like to conduct another prospective study to further evaluate the efficacy and safety of Sentire Surgical System C1000 in major gastrointestinal and urologic surgery with expanded indications. It is believed that the results of this study will provide data to support its use for wide range of procedures with minimal access trauma, for the benefit of patients. This system will also lead to a wider range of clinical application for minimally invasive surgery with a cost-effective model.
NCT06916130
Primary endpoint of this study is to evaluate the pharmacokinetic and pharmacodynamic characteristics of AD-120 in healthy subjects.