Registry of Outcomes From AntiReflux Surgery
Gastroesophageal Reflux DiseaseHiatal HerniaProspective registry comparing outcomes after laparoscopic treatment of gastroesophageal reflux disease and hiatal hernia.
Safety and Efficacy of AST-120 in Patients With GERD Who Continue to be Symptomatic on a Standard...
Gastroesophageal Reflux Disease (GERD)The purpose of this project is to test how safe and how well AST-120, an investigational product, works in treating too much acid in the stomach. Patients will be randomly assigned to one of two groups, AST-120 or a placebo for the first four weeks of the study. The patients will be switched to the other group (AST-120 or placebo)for the following four weeks.
Efficacy and Safety of DLBS2411 in the Management of GERD
Gastroesophageal Reflux Disease (GERD)This is a 2-arm, prospective, double-blind double-dummy, randomized-controlled study comparing DLBS2411 at a dose of 250 mg twice daily with omeprazole at a dose of 20 mg twice daily, given before morning and evening meals, for an 8-week course of therapy. Subjects should avoid taking meals 2-3 hours before bedtime. The bioactive fraction of DLBS2411 has been proved at cellular and genetic levels to have an antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+ ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus suppressing gastric acid secretion; while its cytoprotective defense mechanism works through the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation. Recent study of DLBS2411 which was conducted in healthy volunteers, demonstrated the effective role and safety of DLBS2411 in suppressing intragastric acidity. Having such mechanisms of action, DLBS2411 is hypothesized to benefit patients with gastric acid disorders such as in gastroesophageal reflux disease (GERD).
Transoral Fundoplication Prior to Sleeve Gastrectomy Versus RNY Gastric Bypass on GERD Symptoms...
Gastroesophageal Reflux DiseaseA prospective cohort study to compare the effect of completing a Transoral Fundoplication (TF) procedure prior to Sleeve Gastrectomy (SG) surgery to Roux-en-Y Gastric Bypass (RNYGB) in bariatric patients with GERD symptoms. The aim of this study is to examine the effect of TF prior to sleeve gastrectomy as compared to Roux-en-Y Gastric Bypass on reflux symptoms in bariatric patients. We propose that performing a TF procedure prior to a sleeve gastrectomy will result in a decrease in GERD symptoms similar to that of a RNY gastric bypass.
Sleep Position May Reduce Acid Reflux Symptoms at Night
Extra-esophageal RefluxThis study is designed to determine if the addition of the MedclineTM Sleep Assist Device will decrease night-time gastroesophageal reflux disease events.
Retrospective TIF Study for Treatment of Gastroesophageal Reflux Disease (GERD). The RetroTIF Study...
Gastroesophageal Reflux Disease (GERD)The purpose of this retrospective, open-label, post-market study is to evaluate the safety and efficacy of Transoral Incisionless Fundoplication (TIF) performed with EsophyX (brand name) in a broad range of GastroEsophageal Reflux Disease (GERD) patients treated at high volume centers across the United States.
A Study to Determine the Effectiveness of Endoscopic Full-Thickness Plication for the Treatment...
Gastroesophageal Reflux Disease (GERD)The aim of this study was to determine the effectiveness of endoscopic full-thickness plication (Plicator; NDO Surgical, Inc., Mansfield, MA) for the treatment of GERD in comparison to a sham procedure. Patients with symptomatic GERD requiring maintenance proton pump inhibitor therapy were entered into a randomized, single-blind, prospective, multicenter trial. Seventy-eight patients were randomly assigned to undergo endoscopic full-thickness restructuring of the gastric cardia with transmural suture. Eighty-one patients underwent a sham procedure. Group assignments were revealed following the 3-month evaluation. The primary endpoint was ≥ 50% improvement in GERD-HRQL score. Secondary endpoints included medication use and esophageal acid exposure. Patients achieving ≥ 50% improvement in GERD-HRQL score at 3-months versus baseline off-meds were considered responsive to their assigned procedure. Patients who failed to reach this level of improvement at 3-months were considered non-responders. Analysis of these dichotomized variables (responder/non-responder) was done using Fisher's exact test comparing the proportion of responders between the active and sham groups. Intent-to-treat analysis was also performed. The null hypothesis was that the proportion of responders was the same in both the active and sham groups. Testing was done at the 5% level of significance (alpha=0.05).
Endoscopic Fundoplication Versus Proton Pump Inhibitors for GERD Treatment
Gastroesophageal Reflux Disease (GERD)The study objective is to evaluate the relative merits, safety and effectiveness of Transoral Incisionless Fundoplication (TIF) in GERD patients currently treated with daily Proton Pump Inhibitors (PPIs).
Prescription Methods Assessment Project (PMAP)
OsteoarthritisGastroesophageal Reflux DiseaseThe purpose of this study is to evaluate whether a novel prescription method (N-of-1 intervention)can be successfully integrated into primary care practices and to examine the effects of this prescription method on selected patient health outcomes (e.g.., medication compliance, medication costs, symptom management, satisfaction of physician/patient visit, etc.) in patients with a uncontrolled or new diagnosis of Osteoarthritis or Chronic Heartburn (GERD).
Elucidation of Acid-Induced Pulmonary Inflammation
Gastroesophageal RefluxAsthmaThis study will evaluate how heartburn may lead to different types of inflammation in one's airways. Additionally, the study will determine whether aggressive treatment of heartburn results in improvement in both symptoms of heartburn and asthma but also in documented improvement in airway inflammation as determined by biopsy. The results of this study will be important in directing future research into the relationship between heartburn and asthma and may provide a clue whether certain subtypes of asthma may be caused primarily by gastroesophageal reflux (GER).