Clinical Research Directory

Validation of the C-mo System - Cough Monitoring

The goal of this clinical study is to validate C-mo System's ability to automatically detect and characterise cough, in patients over 2 years old with cough as a key or refractory symptom. The main questions it aims to answer are: 1. Can C-mo System detect cough events? (automatic cough detection) 2. Can C-mo System characterise cough events? (calculation of cough intensity, identification of cough type and presence of wheeze in detected coughs) Participants will be asked to: * Wear the C-mo Wearable device for 24 hours (1 day); * Complete a diary with relevant activities throughout the monitoring period; * Fill-out questionnaires related to coughing frequency and intensity, usability of the device, and impact of cough on quality of life.

Clinical Utility of WATS3D: A 5-Year Prospective Study

The purpose of this study is to create a registry (collect data and keep it in a research database) to learn more about two methods of taking small tissue samples from your esophagus (the esophagus is the tube that carries food and liquid from your mouth to your stomach). The two methods of sampling are: 1) Using forceps that take biopsies (small tissue samples) from your esophagus, and 2) Using a brush that also takes biopsies from your esophagus.

Prevalence of Symptomatic Gastroesophageal Reflux Disease in Czech Children (Czech GERDKids)

This study aims to determine the prevalence of symptomatic gastroesophageal reflux disease (GERD) in children aged 8-9 years and 12-13 years in the Czech Republic. Participants are recruited through schools and complete a web-based questionnaire assessing reflux-related symptoms. Children reporting pyrosis or regurgitation undergo a stepwise diagnostic evaluation that includes a standardized proton pump inhibitor (PPI) trial, upper endoscopy when indicated, and 24-hour pH-impedance monitoring for those with inconclusive findings. These procedures allow classification into confirmed GERD, reflux hypersensitivity, or functional pyrosis. All children undergoing diagnostic testing complete a validated quality-of-life questionnaire. The study will provide population-based prevalence estimates and evaluate symptom burden and potential risk factors associated with pediatric GERD.

Anti-Reflux Endoscopic TX Using APC (AREA) in GERD Patients: (The AREA Study)

This will be a randomized clinical trial examining the efficacy and safety of ARAT (intervention group) in patients with chronic GERD symptoms (typical symptoms of GERD, i.e. heartburn or acid reflux/regurgitation at least twice a week) for the last 6 months. Patients must have a positive pH test and a negative manometry (no treatment) procedure.

Efficacy Of Hiatal Closure For GERD

The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD.

Gastrointestinal Dysmotility on Aspiration Risk

The hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. The investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspiration-associated symptoms.

Transpyloric Feeding for Prevention of Micro-aspiration

To determine the effect of transpyloric (TP) feeding on microaspiration and lung inflammation in ventilated preterm infants.

Association Between Obesity and Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) is a chronic disorder marked by heartburn and regurgitation, resulting from the reflux of gastric acid or bile into the esophagus. Chronic acid exposure leads to mucosal inflammation, erosive esophagitis, and Barrett's esophagus, conditions that increase the risk of esophageal adenocarcinoma (Badreddine RJ et al., 2010; Fass R, 2022). Obesity, defined by the World Health Organization as a body mass index (BMI) ≥30 kg/m², is recognized as a major global public health issue due to its rapidly rising prevalence and strong association with chronic disease. It is not only a cause of metabolic disorders but also a driver of systemic health complications (WHO, 2024). Obesity is linked with type 2 diabetes, cardiovascular disease, hypertension, non-alcoholic fatty liver disease, certain cancers, and sleep apnea. Additionally, it negatively impacts psychological well-being, contributing to depression, low self-esteem, and social stigma (CDC, 2024). Evidence suggests a strong link between obesity and GERD. Studies demonstrate that obese individuals exhibit higher intra-gastric pressure, delayed esophageal transit, increased esophageal acid exposure, and a greater prevalence of defective lower esophageal sphincter function. These pathophysiological mechanisms contribute significantly to GERD development and its complications (de Vries DR et al., 2008; Cote-Daigneault J et al., 2014; Anggiansah R et al., 2013; Ayazi S et al., 2009). The rationale for this study is to explore the relationship between obesity and GERD, given the rising prevalence of obesity and its implications for gastrointestinal health. Diagnosis of GERD is primarily clinical, based on symptoms such as heartburn and regurgitation. A trial of proton pump inhibitors for 4-8 weeks is recommended in patients without alarm features. Endoscopy is indicated for those with alarm signs or refractory disease, while pH monitoring is the gold standard in uncertain cases. Manometry is reserved for pre-surgical evaluation (Katz PO et al., 2022).To study the relationship between Obesity and GERD, given the rising prevalence of obesity and its potential impact on gastrointestinal health.

Comparison of Nissen-Sleeve and Gastric Bypass for GERD in Obese Patients

This randomized clinical trial aims to compare two surgical techniques for the treatment of obesity in patients who also have symptoms of gastroesophageal reflux disease (GERD). The study will compare Nissen-Sleeve Gastrectomy (N-SG)-a sleeve gastrectomy combined with a reflux-preventing procedure-to the Roux-en-Y Gastric Bypass (RYGB), which is the current standard surgical option for obese patients with GERD. Both procedures are widely used to treat severe obesity, but they differ in how they affect the digestive system and the potential for reflux control, nutritional outcomes, and future surgical options. N-SG is a newer technique that preserves the natural pathway of the gastrointestinal tract and allows standard endoscopic access to the bile ducts, which may be beneficial for long-term patient care. RYGB, on the other hand, bypasses part of the stomach and small intestine, which may lead to better reflux resolution but carries risks of nutritional deficiencies and altered anatomy. Eligible participants with obesity and GERD symptoms will be randomly assigned to receive either N-SG or RYGB. The primary goal is to evaluate whether N-SG is not inferior to RYGB in reducing GERD symptoms one year after surgery. Secondary outcomes include weight loss, quality of life, surgical complications, and changes in the hormone ghrelin, which is involved in appetite regulation. In addition, a larger control group of patients without GERD undergoing standard sleeve gastrectomy will be recruited to allow further comparisons. All participants will be followed for one year after surgery, with blood samples, questionnaires, and clinical data collected to assess both metabolic and reflux-related outcomes. This study is being conducted at the University Hospital in Kraków, Poland, and aims to improve the personalization of bariatric treatment for patients suffering from both obesity and reflux.

The Effect of Inspiratory Muscle Training in People With Gastroesophageal Reflux Disease

The present Randomized Control Trial will be a single centric, two arm parallel equivalence randomized controlled. Participants will be assigned to either the Inspiratory MuscleTraining (IMT) group (investigation) or to Sham IMT group (control). The assessment times were three (3) before the start of the program (baseline-T1), immediately after the 3 months of the main exercise program (end of the main program-T2) and 6 months after (end of follow up-T3). The measurements included: A. By measuring the Maximum Inspiratory Pressure (MIP) (Micro RPM) B. By measuring the Maximum Dynamic Inspiratory Pressure s-index (Powerbrethe K5) The following instruments were included in the secondary outcome measures: * Recurrent Gastroesophageal Reflux Disease Questionnaire (measurement of symptom frequency-RDQ Questionaire). * Gastroesophageal Reflux Disease-Related Quality of Life Questionnaire (Quality of Life Measure-Reflux Qual short form questionnaire).

Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry

The purpose of this registry study is to collect data through medical chart review and in patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs). This is a retrospective and prospective, observational, medical chart review study for at least 6 standard of care visits up to 1 years after a subject consents for study participation.

Assessment of Esophageal Epithelium Integrity With Use of a Novel Mucosal Impedance Device

The objective of this study is to design and use a novel, minimally invasive mucosal impedance (MI) technology to inexpensively and accurately test mucosal health in suspected gastroesophageal reflux disease (GERD) and nonerosive reflux disease (NERD) patients as compared to those without GERD.

The Effect of Postural Correction On Gastroesophageal Reflux Disease

The main aim of this randomized controlled trial is to investigate the effects of postural correctional exercises and interventions on the severity of symptoms of gastroesophageal reflux disease (GERD) as well as the quality of life of patients afflicated with this disease. The main questions this study aims to answer is: 1. Do postural correctional exercises reduce the symptoms of GERD? 2. Do postural correctional exercises improve the quality of life of individuals afflicted with GERD? The experimental group in this study will undergo real postural correctional exercises whereas the control group will undergo sham postural correctional interventions and then the two groups will be compared post-treatment based on GERD severity of symptoms as well as quality of life of the patients afflicted with GERD.

Efficacy and Safety of EsoDuo®

Clinical Trial to Evaluate the Effects of EsoDuo® in Controlling Reflux Symptoms Related to the Acid

Esophageal and Gastric Registry and Biorepository

The evaluation of the foregut, the esophagus and stomach, has come a long way over the past two decades, and continues to experience exciting discoveries in the clinical evaluation of foregut physiology. Assessing esophageal peristalsis has relied for the past several decades on High Resolution Manometry (HRM), however it has recently become known that even though HRM is an extremely effective tool, that there are certain subsets of patients in which additional information is required. Additionally, the assessment of esophageal reflux disease has relied on pH impedance for the last two decades. However, this procedure requires a catheter to be passed through a nostril and remain in place for at least 24 hours. Novel techniques, already FDA approved, including EndoFLIP for esophageal peristalsis and mucosal integrity (MI) for reflux disease, have emerged as time-of-endoscopy assessments. Both involve the placement of a balloon through the scope at time of upper endoscopy (standard first line assessment for both dysphagia and reflux symptoms) and are quick and pose little-to-no additional risk or discomfort for patients. However, data regarding normal esophageal parameters are poorly defined for both EndoFLIP and MI. Additionally, EndoFLIP has increasingly been used to assess the pylorus, and scarce data exists there regarding how a tool originally envisioned for esophageal assessment can be used more distally in the GI tract. We will recruit healthy, asymptomatic volunteers to undergo testing with MI and FLIP (esophageal and pyloric). The data obtained will help establish the benchmark from which assessments can be made in patients.

Observational Registry of Transoral Incisionless Fundoplication (TIF) for Gastroesophageal Reflux Disease (GERD)

This observational registry aims to: 1) record the TIF interventions in patients with esophageal or extra-esophageal symptoms; 2) to monitor the therapy response through the clinical experience in terms of effect on the use and dosage of proton pump inhibitors (PPIs) and on the GERD-Health Related Quality of Life (HRQL) and Reflux Symptom Index (RSI) questionnaires scores; 3) to characterize the treated patients population and the predictive factors of TIF success, identifying the subpopulation who may effectively benefit from TIF.