Study to Evaluate the Safety and Efficacy of X842 in Patients With Reflux Esophagitis
Reflux EsophagitisThe purpose of the study is to investigate the efficacy and dose-effect relationship of X842 capsules at different dosages in the treatment of reflux esophagitis for 4 weeks in comparison with lansoprazole enteric-coated capsules.
Effect of Full-thickness Gastroplication With the GERD-X System on Atypical Gastro-esophageal-reflux-symptoms...
Atypical Gastroesophageal Reflux SymptomsObjectified Gastroesophageal Reflux DiseasePatients with atypical symptoms of objectified gastroesophageal reflux disease will be treated by full-thickness gastroplication and the effect of this intervention will be measured by questionnaires and clinical diagnostics (for example pH/MII).
The Effect of Chlorpromazine on Esophageal Sensitivity in Healthy Volunteers.
Esophageal RefluxThe effect of chlorpromazine (Largactil) on esophageal sensitivity will be investigated in this study. Overnight fasted subjects will be asked to fill out 2 questionnaires to assess the emotional status before their onset of the stimulation tests. The multimodal stimulation probe will be positioned through the mouth in the distal esophagus. After the ingestion of the stimulation probe, 10mg of chlorpromazine or placebo (saline) will be slowly administered via intravenous injection. Hereafter the multimodal stimulation tests will be initiated. Esophageal sensitivity will be assessed by performing thermal, mechanical, electrical and chemical stimulation of the esophagus. The chlorpromazine condition will be compared with a placebo condition, this will be organised on 2 separate study visits in a randomised order.
Trial to Assess the Effectiveness of Educational Outreach in Prescription Guidelines
InflammationGastroesophageal Reflux2 moreBackground: The Portuguese National Health Directorate has issued clinical practice guidelines on prescription of anti-inflammatory drugs and COX-2 inhibitors, acid suppressive therapy and proton pump inhibitors, and anti-platelets. However, their effectiveness in changing actual practice is unknown. The objectives will be to compare the effectiveness of educational outreach visits in the implementation of clinical guidelines in primary care in Portugal against usual implementation strategies and to conduct a cost-effectiveness analysis of this method. Methods: The trial will be a parallel, cluster-randomized, unblinded, trial in primary care, with a 1:1 allocation ratio. This study will assess the effect of educational outreach visits on physician compliance with prescription guidelines. The general study hypothesis is whether educational outreach visits are superior to usual implementation of guidelines regarding the reduction of inappropriate prescribing (compliance with prescription guidelines). All National Health Service primary care units in the Lisbon (Portugal) region will be invited to participate. Units will be eligible if they are using an Electronic Health Record to issue prescriptions and have at least four doctors willing to participate. Doctors in intervention units will receive three educational outreach visits (one for each guideline) during a six months period, while the control group doctors will be offered an unrelated group training session (on using the international classification for primary care). Intervention visits will be one on one 15 minutes discussions conducted by guideline authors or trained family physicians at the physician's workplace. There are two primary outcomes, measured at the physician's level. One is the proportion of COX-2 inhibitors prescribed within the entire NSAID class, in defined daily doses 18 months after the intervention. The other is the proportion of omeprazole within the entire proton pump inhibitors class, in defined daily doses at 18 months post-intervention. Prescription data will be collected from the regional pharmacy claims database.
FODMAPs and Refractory GERD
Gastro-esophageal Reflux Disease (GERD)The aim of this study is to determine the effects of a low Fermentescible Oligosaccharides Disaccharides Monosaccharides and Polyols (FODMAP) diet in patients with documented refractory GERD on proton pump inhibitor (PPI) therapy.
Full-Thickness-Gastroplication For The Treatment Of Gastroesophageal Reflux Disease GERD
Gastroesophageal Reflux DiseaseThis is a prospective study to extensively evaluate subjective patient parameters on quality of life, reflux-symptoms, side effects, medication-use and measurements of esophageal manometry and Impedance-pH-Monitoring after Full-Thickness-Gastroplication.
A Prospective, Observational Study of the PPI Non-responder
Gastro Esophageal Reflux Disease PPI Non-RespondersGastroesophageal reflux disease (GERD) is a common chronic condition, affecting approximately 20% of the American adult population. Proton pump inhibitors (PPIs) are now the mainstay of medical therapy for symptoms of GERD. Despite their efficacy, several studies have shown that a significant proportion of GERD patients are either partial or non-responders to PPI therapy, defined as symptoms of heartburn and/or regurgitation not relieved by either a standard or double dose of a PPI during a minimum trial of 8 weeks. If GERD symptoms persist, further testing is required. This study will mirror the real world setting to assess the value of published guidelines which recommend specific testing and treatment.
A Study of Dexlansoprazole Modified Release (MR) in Gastroesophageal Reflux Disease (GERD) Participants...
Gastroesophageal Reflux DiseaseThe primary purpose of the study is to evaluate effect of Dexilant treatment among GERD participants in the Russian Federation.
Impact of Maternal-infant Therapeutics on Safety, Mortality, and Disability
Gastroesophageal RefluxPresumed Sepsis3 moreThe purpose of this research is to address the comparative effectiveness and harm of the therapeutics frequently given to pregnant women and their young infants including antibiotics, tocolytic agents, non-steroidal anti-inflammatory drugs, H2 blockers, and steroids. Our overall hypothesis is that the use of an existing electronic medical record with additional resources for precise data collection and 18 month follow up will successfully address current knowledge gaps in therapeutic effectiveness and relative therapeutic harm. We will use an existing electronic medical record into which detailed healthcare information is entered for over 100,000 newborns each year. These infants will comprise the "Source Cohort". Nested within that database, we will prospectively enroll 10% of the population (10,000 newborns) as the Follow-Up Cohort. The current electronic medical record for the Source Cohort does not capture therapeutic dosing with sufficient precision to conduct comparative effectiveness research sufficient to change medical practice. The proposed research will: 1) ensure accurate data collection through electronic monitoring and real-time quality assurance evaluation in the Source Cohort; and 2) conduct 18 months post-hospital follow-up for neurologic outcomes and disability for the Follow-Up Cohort. We will complete assessments of neurologic outcomes and disability using an interactive web-based system, mail, telephone follow up, and in-person examination.
Nasopharyngeal 24 Hour pH Monitoring in Health Adult Volunteers
Gastroesophageal Reflux DiseaseInvolves a 24-hour pH probe study using the Dx-pH Measurement System on patients who do not have symptoms of laryngopharyngeal reflux or gastroesophageal reflux disease to establish normal values for the Dx-pH Measurement System.