Clinical trials: Lower Gastrointestinal Disorder
Cystic Fibrosis
Aztreonam Lysine for Pseudomonas Infection Eradication Study
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection.
- Trial name
- ALPINE (NCT01375049)
- Testing
- Aztreonam for Inhalation Solution (AZLI)
- Where
- 58 sites in United States, Austria and 7 more
- Volunteers
- 105 people
- Sponsor
- Gilead Sciences
GERD, Morbid Obesity
Management of Reflux After Sleeve Using Stretta
Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities.
- Trial name
- MaRSS (NCT02637713)
- Testing
- Stretta, Radiofrequency (RF) Energy to the LES (Stretta Procedure)
- Where
- 13 sites in United States
- Volunteers
- 5 people
- Sponsor
- Montefiore Medical Center
Urinary Retention, Urinary Urge Incontinence
Axonics SacRal NeuromodulaTIon System RegisTRY Study
To assess the post-market clinical outcomes with use of the Axonics Sacral Neuromodulation System(s).
- Conditions
- Urinary Retention, Urinary Urge Incontinence, Urgency-Frequency, Fecal Incontinence
- Trial name
- ARTISTRY (NCT05064384)
- Where
- 27 sites in United States, Canada
- Volunteers
- 272 people
- Sponsor
- Axonics, Inc.
Gastroesophageal Reflux Disease
Phase IV Study of the Impact of Dietary Fibers on Symptoms and Esophageal Motility in Patients With Non-erosive GERD
Gastroesophageal reflux disease (GERD) is a chronic condition, which may significantly decrease patients' quality of life due to the typical symptoms - heartburn and regurgitation.
- Trial name
- OGIG-130-1 (NCT01882088)
- Testing
- Mucofalk
- Where
- Russia
- Volunteers
- 36 people
- Sponsor
- Russian Academy of Medical Sciences
Fecal Incontinence
Autologous Cell Therapy for Treatment of Fecal Incontinence
The aim of this clinical study is to investigate the safety and feasibility of Autologous Muscle Derived Cells (AMDC, generic name iltamiocel, preparation of a patient's own cells) injection into the anal sphincter for treatment…
- Trial name
- NCT01600755
- Testing
- Iltamiocel
- Where
- 2 sites in Canada, United Kingdom
- Volunteers
- 53 people
- Sponsor
- Cook MyoSite
Antibiotic Enterocolitis
Effect of Antibiotics on Enteric Neurons and Glia
The interactions between bacteria and their products with the intestinal tissue are important for maintaining a healthy and balanced system.
- Trial name
- NCT05834036
- Testing
- Amoxicillin Oral Capsule
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Crohn's Disease
Cimzia Versus Mesalamine for Crohn's Recurrence
Hypothesis: Cimzia provides superior reduction in endoscopic and clinical recurrence rates compared to mesalamine in the treatment of Crohn's disease one-year following ileocolectomy for Crohn's disease. 1.
- Trial name
- NCT01696942
- Testing
- Cimzia, Mesalamine
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Milton S. Hershey Medical Center
Medium and Lower Rectal Cancer
Efficacy of Delayed Coloanal Anastomosis for Medium and Lower Rectum Cancer Treatment. Phase 2 Clinical Trial (CASCADOR)
Hypothesis: In France, approximately 12,000 new rectal cancers are diagnosed each year. Frequency is one and a half times higher in men than in women. The average age of diagnosis is 65.
- Trial name
- CASCADOR (NCT01876901)
- Testing
- 2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA), Colo-anal anastomosis (CAA)
- Where
- 9 sites in France
- Volunteers
- 124 people
- Sponsor
- Institut Bergonié
Acute Graft-Versus-Host Disease, GIGVHD
A Phase 2A Study of ALXN1007 in Participants With Newly Diagnosed Acute Lower Gastrointestinal Graft-Versus-Host Disease
The objectives of this trial were to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics (PK/PD) and efficacy of intravenous (IV) ALXN1007 in participants with acute graft-versus-host disease (GVHD) of the lower…
- Trial name
- GIGVHD (NCT02245412)
- Testing
- ALXN1007 10 mg/kg once weekly, ALXN1007 20 mg/kg once weekly, ALXN1007 20 mg/kg twice weekly
- Where
- 12 sites in United States, France
- Volunteers
- 25 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Gastroesophageal Reflux Disease (GERD), Reflux, Gastroesophageal
An Investigation of the EndoStim® Lower Esophageal Sphincter (LES) Stimulation System for the Treatment of Reflux
The purpose of this investigation is to demonstrate the safety and effectiveness of Lower Esophageal Sphincter (LES) Stimulation System in treating gastroesophageal reflux disease (GERD).
- Conditions
- Gastroesophageal Reflux Disease (GERD), Reflux, Gastroesophageal, Gastroesophageal Reflux, Acid Reflux
- Trial name
- NCT02749071
- Testing
- Laparoscopic implantation surgery with or without crural repair, EndoStim stimulation for first six months of study, EndoStim stimulation from Month 6 thru end of study
- Where
- 21 sites in United States, Belgium and 2 more
- Volunteers
- 161 people
- Sponsor
- EndoStim Inc.
Urinary Incontinence, Cystic Fibrosis
Cystic Fibrosis and Urinary Incontinence
Evaluate the feasibility of a randomized controlled trial of non-surgical urinary incontinence (UI) management options for women with CF.
- Trial name
- NCT04922255
- Testing
- Reusable Underwear, Disposable urethral support, Pelvic floor physical therapy
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Megan Bradley
Cystic Fibrosis
Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis
This study assessed time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution.
- Trial name
- ELITE (NCT00391976)
- Testing
- Tobramycin solution for inhalation 300 mg
- Volunteers
- 123 people
- Sponsor
- Novartis
Refractory Reflux Esophagitis
Compare D961H 20 mg Bid and 20 mg qd in Patients With Refractory Reflux Esophagitis (Inflammation of Lower Esophagus)
This is a phase 3 multicentre, randomised, double-blind, parallel-group, comparative study to evaluate the efficacy of esomeprazole (D961H) 20 mg twice daily and esomeprazole (D961H) 20 mg once daily in patients (in the form of…
- Trial name
- NCT01669811
- Testing
- Esomeprazole (D961H) twice daily, Esomeprazole (D961H) once daily
- Where
- 63 sites in Japan
- Volunteers
- 1,398 people
- Sponsor
- AstraZeneca
Venous Insufficiency, Venous Reflux
Effects of Non Contact Low Frequency Ultrasound in Healing Venous Leg Ulcers
This trial is a prospective, randomized, controlled, multi-center study of subjects presenting with chronic lower extremity venous ulcers.
- Conditions
- Venous Insufficiency, Venous Reflux, Lower Extremity Ulcer
- Trial name
- NCT01549860
- Testing
- MIST Therapy
- Where
- United States
- Volunteers
- 156 people
- Sponsor
- Celleration, Inc.
Reflux Episodes
TLESR-impedance Study in Patients
The purpose of the study is to compare frequency and content of reflux episodes in patients with gastroesophageal reflux disease.
- Trial name
- NCT00743444
- Testing
- AZD3355
- Volunteers
- 27 people
- Sponsor
- AstraZeneca
Graft Versus Host Disease
A Phase 2/3 Study of GLASSIA for the Treatment of Acute GvHD
The purpose of the study is to evaluate the safety and efficacy of GLASSIA as an add-on biopharmacotherapy to standard-of-care steroid treatment as the first-line treatment in participants with acute GvHD with lower GI…
- Trial name
- NCT02956122
- Testing
- GLASSIA, methylprednisolone or equivalent steroid, Albumin
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Baxalta now part of Shire
Spinal Tumor
A Prospective Study Using Implanted Fiducial Markers to Assess Treatment Accuracy and Esophageal Toxicity in Spinal Stereotactic Body Radiation Therapy
The goal of the first part of this clinical research study is to learn how to deliver more accurate radiation treatment of tumors in the spine.
- Trial name
- NCT01624220
- Testing
- Spinal SBRT (Standard Dose), Spinal SBRT (Higher Dose), Gold Seed Implantation
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- M.D. Anderson Cancer Center
Gastric Adenocarcinoma, Barrett Esophagus
Efficacy and Safety of Sunitinib in Metastatic Gastric Cancer
This trial will be conducted to evaluate the efficacy, safety, and tolerability of sunitinib (sunitinib-malate) as a second-line palliative therapy in metastatic gastric cancer.
- Trial name
- NCT00411151
- Testing
- Sunitinib-Malate
- Where
- 12 sites in Germany
- Volunteers
- 52 people
- Sponsor
- Johannes Gutenberg University Mainz
Lung Diseases, Medication Compliance
Uncontrolled Lower Respiratory Symptoms in the WTC Survivor Program
The purpose of this study is to understand why patients in the World Trade Center program have continuing breathing problems. This study will improve investigators understanding of breathing problems among individuals with World…
- Trial name
- NCT02024204
- Testing
- Fluticasone propionate 230mcg for 3 Months, Current Treatment or no treatment, Salmeterol 21mcg for 3 Months
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- NYU Langone Health