Clinical trials: Lower Gastrointestinal Tract
Hypercholesterolemia
Effect of Beta-Glucan on Cholesterol Lowering
The primary aim of this study is to determine whether the cholesterol-lowering efficacy of barley b- glucan varied as function of molecular weight (MW) and the total daily amount consumed.
- Trial name
- NCT01408719
- Testing
- Control, 3g LMW beta-glucan, 5g LMW beta-glucan
- Where
- Canada
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- University of Manitoba
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
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
Overactive Bladder, Urge Incontinence
Lidocaine Patches Prior to Percutaneous Nerve Evaluation
The study will be a double-blind randomized control trial comparing 4% lidocaine patch placed over the sacrum 3 minutes prior to a percutaneous nerve evaluation (PNE) procedure to a placebo patch in patients already scheduled to…
- Conditions
- Overactive Bladder, Urge Incontinence, Fecal Incontinence
- Trial name
- NCT05783219
- Testing
- Lidocaine patch
- Where
- 2 sites in United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- University of Louisville
Urinary Incontinence, Stress, Fecal Incontinence
Does Single Dose Imipramine Affect the Opening Pressure of the Urethral and Anal Sphincter?
A double-blinded, randomized, crossover study in healthy females with placebo and single dose imipramine 50 mg. Primary objective: Does imipramine increase the tone of the external urethral sphincter? Urethral Opening Pressure…
- Trial name
- NCT03102645
- Testing
- Imipramine Hydrochloride 25 MG
- Where
- Denmark
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Jonatan Kornholt
Constipation
Naloxegol to Prevent Lower Gastrointestinal Paralysis in Critically Ill Adults Administered Opioids
This study evaluates the addition of naloxegol (Movantik) to a laxative protocol in critically ill adults requiring scheduled opioid (e.g. fentanyl) therapy.
- Trial name
- NCT02977286
- Testing
- Naloxegol Oral Tablet, Docusate Sodium 100 Mg oral capsule [Colace], Senna 217 Mg Oral Tablet
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Tufts Medical Center
Pelvic Organ Prolapse, Urinary Incontinence,Stress
Minimally Invasive Burch Colposuspension to Reduce Occult Stress Incontinence
This study evaluates the addition of a laparoscopic Burch colposuspension procedure at the time of laparoscopic sacrocolpopexy to prevent stress urinary incontinence.
- Conditions
- Pelvic Organ Prolapse, Urinary Incontinence,Stress, Urinary Incontinence, Urge, Bowel Dysfunction
- Trial name
- MICRO (NCT03841513)
- Testing
- Laparoscopic Burch Colposuspension
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Northwestern University
Overactive Bladder, Urinary Incontinence
Percutaneous Nerve Evaluation With Fluoroscopy Versus Without
The investigators propose a randomized control trial comparing the rate of implantation of the InterStim device following Percutaneous Nerve Evaluation (PNE) performed with or without fluoroscopic guidance.
- Conditions
- Overactive Bladder, Urinary Incontinence, Fecal Incontinence
- Trial name
- NCT02677753
- Testing
- Fluoroscopy
- Where
- United States
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- University of Louisville
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.
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
Breast Cancer, Prostate Cancer
Survivorship Promotion In Reducing IGF-1 Trial
This is a prospective, single-center randomized trial with three arms, and an allocation ratio of 1:1:1. The study design is an efficacy study to evaluate the effect of metformin and coach-directed behavioral weight loss versus…
- Conditions
- Breast Cancer, Prostate Cancer, Lung Cancer, Colon Cancer
- Trial name
- SPIRIT (NCT02431676)
- Testing
- Metformin, Coach Directed Behavioral Weight Loss, Self-control weight loss
- Where
- United States
- Volunteers
- 121 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Overactive Bladder, Fecal Incontinence
InterStim Micro Post Market Clinical Follow-up Study (ELITE)
Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the InterStim Micro System for sacral neuromodulation.
- Conditions
- Overactive Bladder, Fecal Incontinence, Non-obstructive Urinary Retention
- Trial name
- ELITE (NCT04506866)
- Testing
- InterStim Micro
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 148 people
- Sponsor
- MedtronicNeuro
Dual Incontinence, Fecal Incontinence
Sacral Neuromodulation in Dual Incontinence: Ultrasound and Afferent Nerve Sensation Assessment
Women with Dual Incontinence (DI) (both Urinary Incontinence (UI) and Fecal Incontinence (FI)) often have more bothersome symptoms, quality of life impact, and sexual dysfunction than those with just UI or FI.
- Conditions
- Dual Incontinence, Fecal Incontinence, Urinary Incontinence, Sacral Neuromodulation
- Trial name
- SaNDI (NCT02357784)
- Testing
- Neurometer
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Northwestern University
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
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
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
HIV/AIDS
Quantification of Estradiol's Impact on Nucleotides in Cellular Populations of the Lower GI Tract
Purpose: To Assess the impact of high and low in vivo estradiol exposure on PrEP (Pre-exposure prophylaxis) nucleotide concentrations in different cellular populations of the lower GI (gastrointestinal) tract and to quantify the…
- Trial name
- NCT03917420
- Testing
- Tenofovir 300Mg Oral Tablet, Emtricitabine 200 MG
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
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
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.
Fecal Incontinence
Prevalence and Treatment of Anal Incontinence (AI) in Primiparous Women
Traumatic tears of the sphincter ani muscles after delivery may result in symptomatic urinary and anal incontinence, particularly in primiparas.
- Trial name
- NCT00970320
- Testing
- Pelvic floor muscle training
- Where
- Norway
- Volunteers
- 1,718 people, healthy volunteers welcome
- Sponsor
- Ostfold Hospital Trust