Prospective Pediatric Vesicoureteral Reflux Surgery Database
The purpose of this research is to provide a clearer understanding of quality and outcomes for three types of surgical procedures performed at Connecticut Children's for treatment of vesicoureteral reflux. In order to consistently gather data over time, the investigators propose to establish database for surgical intervention for vesicoureteral reflux. Specific Aim 1: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to increase internal understanding of these procedures. Specific Aim2: To consistently collect performance and outcomes data for the surgical treatment of vesicoureteral reflux in order to perform more valuable clinical analysis for publication.
NCT01373385 — Vesicoureteral Reflux
Status: Completed
http://inclinicaltrials.com/vesicoureteral-reflux/NCT01373385/
Role of Gastroesophageal Acid Reflux at Squamo-columnar Junction in Functional Dyspepsia
Background: Functional dyspepsia is one of the commonest digestive disorders. The pathophysiology of functional dyspepsia is uncertain. Proton pump inhibitor (PPI) has been recommended as the first line treatment for functional dyspepsia. However, the results on effectiveness of PPI are conflicting and it has been suggested that PPI is only effective for acid-related symptoms. The investigators plan to use a wireless pH monitoring system positioned at the junction of esophagus and stomach to evaluate the chronological relationship between acid exposure at this region and symptoms of dyspepsia as well as its impact on the efficacy of acid suppressive therapy in treatment of functional dyspepsia. Indication: Functional dyspepsia patients Study center(s): Prince of Wales Hospital, Hong Kong Aims: 1. To evaluate the chronological relationship between acid exposure at squamo-columnar junction (SCJ) and dyspeptic symptom in different subtypes of functional dyspepsia 2. To evaluate the relationship between acid exposure at squamo-columnar junction and dyspeptic symptom response to PPI 3. To compare the efficacy of PPI and placebo in treating functional dyspepsia patients Study medication: Esomeprazole 20mg vs Placebo o.d. Study design: Double-blind randomized placebo-controlled trial Number of subjects: 130 Patient population: Functional dyspepsia patients without concomitant gastroesophageal reflux disease (GERD) Duration of study: 1 June 2010 - 30 May 2012 Primary variable(s): Proportion of patients who report positive response to adequate relief of dyspeptic symptoms at week 8 Secondary variable(s): Dyspeptic symptom scores, symptom association probability of dyspeptic symptoms in relation to esophageal pH of less than 4 as measured at 1 cm above SCJ. Number of visits: 2 Hypothesis: Increased acid exposure at SCJ contributes to dyspeptic symptom and predicts treatment response to PPI in FD patients without concomitant GERD
NCT01349413 — Gastroesophageal Reflux
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux/NCT01349413/
A Multi-center, Double-blind, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Sodium Alginate Oral Suspension (50 mg/ml) in Comparison to Omeprazole (20 mg/Cap) to Treat Non-erosive Gastro-esophageal Reflux Disease (NERD)
About 60% of patients with typical gastroesophageal reflux symptoms such as heartburn and regurgitation are considered to have non-erosive reflux disease (NERD). Patients with NERD show an overall poorer response to PPI treatment than patients with erosive reflux disease. Sodium alginate oral suspension is a medication indicated for the relief of gastroesophageal reflux symptoms. This multi-center, double blind, randomized trial aims to compare the efficacy and safety profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times daily with that of omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of NERD patients in Taiwan. Efficacy assessments include percentage of patients achieving adequate relief of heartburn or regurgitation after 4 weeks treatment, improvement of reflux symptoms as assessed by reflux disease questionnaire before and after treatment, and patients overall satisfaction at the end of study. Safety assessments include incidence of adverse events and change of the laboratory test results. The study hypothesis is that treatment with sodium alginate is non-inferior to omeprazole in relieving heartburn or regurgitation symptoms of the NERD patients.
NCT01338077 — Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT01338077/
A Randomized, Double-blind, Placebo-controlled Study of Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy
Main Hypothesis: The investigators hypothesize that measurements of lingual tonsil tissue (LTT) thickness will decrease following treatment with once daily oral dexlansoprazole 60 mg in patients diagnosed with laryngopharyngeal reflux (LPR) and lingual tonsil hypertrophy (LTH) compared to matched controls receiving placebo. Primary endpoints include: - 24-hour oropharyngeal pH testing, pre- and post-treatment - Mean lingual tonsil tissue (LTT) thickness, pre- and post-treatment, as determined by CT scan of the base of tongue Secondary endpoints include: - Reflux Finding Score (RFS) on pre- and post-treatment endoscopy of the oropharynx - Subjective outcome metrics for assessing LPR-related symptoms and associated quality of life - Calgary Sleep Apnea Quality of Life Index - Bed-partner assessment of snoring intensity according to a Visual Analog Scale - Epworth Sleepiness Scale (ESS) - Reflux Symptom Index (RSI) Specific Aims: The primary objective of this study is to determine whether treatment of patients diagnosed with LPR and LTH with 3 months of PPI therapy reduces LTT thickness, as measured on CT scan of the tongue base. The secondary objectives of this study are to: - Evaluate changes in LPR-related symptoms and quality of life after therapy using the following subjective outcome metrics: - Calgary Sleep Apnea Quality of Life Index - Bed-partner assessment of snoring intensity according to a Visual Analog Scale - Epworth Sleepiness Scale - Reflux symptom index - Correlate changes in LTT thickness with the following secondary endpoints: - Changes in the above subjective outcome metrics - Changes in endoscopic findings of LPR - Changes in 24-hour oropharyngeal pH study results
NCT01328652 — Laryngopharyngeal Reflux
Status: Not yet recruiting
http://inclinicaltrials.com/laryngopharyngeal-reflux/NCT01328652/
Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Although laryno-pharyngeal reflux (LPR) and gastroesophageal reflux disease (GERD) differ in symptoms and treatment, they are diagnosed by the same standard 24-hour pH monitoring system which measures liquid reflux in the esophagus. The investigators are evaluating a new 24-hour pharyngeal pH monitoring system by Restech which can measure acid exposure in the airway and can be used specifically for LPR diagnosis. The purpose of this study is to determine whether the Restech device is more effective than standard pH monitoring in predicting the response to proton pump inhibitor (PPI) acid suppression therapy using Dexlansoprazole in patients with symptoms and/or manifestations of LPR.
NCT01328392 — Laryngo-pharyngeal Reflux
Status: Withdrawn
http://inclinicaltrials.com/laryngo-pharyngeal-reflux/NCT01328392/
Available data regarding the effectiveness of laparoscopic antireflux surgery on extraesophageal symptoms of gastroesophageal reflux disease (GERD) are scarce and mostly controversial. The aim of the present study was to evaluate the clinical effect of partial and total fundoplication on extraesophageal symptoms in a selected cohort of patients with GERD.
NCT01324986 — Gastroesophageal Reflux Disease (GERD)
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease-gerd/NCT01324986/
Endoscopic full thickness gastroplication (Plicator-Procedure) has the potential to be a safe and effective alternative to laparoscopic antireflux surgery (LARS)to improve symptoms of GERD. This prospective randomized study compares objective and subjective outcome parameters of Plicator with that of LARS.
NCT01324791 — Gastroesophageal Reflux Disease
Status: Completed
http://inclinicaltrials.com/gastroesophageal-reflux-disease/NCT01324791/
Quality of Life in New Treatable Therapy as Rabeprazole Option for Refractory Reflux Esophagitis
To investigate the efficacy and safety of PARIET twice daily (b.i.d.) in patients with Proton Pump Inhibitor-resistant reflux esophagitis
NCT01321567 — Refractory Reflux Esophagitis
Status: Completed
http://inclinicaltrials.com/refractory-reflux-esophagitis/NCT01321567/
A Double-Blinded, Placebo-Controlled Trial to Investigate Dexlansoprazole for the Treatment of Laryngopharyngeal Reflux
Recent studies have demonstrated that patients with throat-related reflux often require twice daily proton pump inhibitor therapy to attain significant symptomatic improvement, with once daily therapy offering little relief. As dexlansoprazole is a twice-daily release proton pump inhibitor requiring only once-daily dosing, it may provide laryngopharyngeal reflux (LPR) symptomatic relief comparable to that of twice daily dosing, yet be more readily approved by third party payers because of its once daily dosing requirements. It is hypothesized that, in patients with pharyngeal-probe proven throat reflux, there will be significantly greater improvement in symptoms and pharyngeal probe findings in those patients receiving dexlansoprazole than those receiving placebo alone.
NCT01317472 — Laryngopharyngeal Reflux
Status: Terminated
http://inclinicaltrials.com/laryngopharyngeal-reflux/NCT01317472/
Effect of a Roux-en-Y Reconstruction on Reflux Esophagitis After Pancreaticoduodenectomy
Reflux esophagitis is a common complication following distal gastrectomy. According to the investigators preliminary data, an Roux-en--Y gastrointestinal reconstruction in pancreaticoduodenectomy is associated with higher rates of reflux esophagitis. In this study, the investigators will investigate the incidence of reflux esophagitis after above procedure by the 24-h pH monitoring of esophagogastric junction.
NCT01311908 — Reflux Esophagitis
Status: Recruiting
http://inclinicaltrials.com/reflux-esophagitis/NCT01311908/