Clinical trials: Digestive Diseases
Colitis, Ulcerative
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with…
- Trial name
- UNIFI Jr (NCT04630028)
- Testing
- Ustekinumab Dose Based on BSA and Body Weight
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Vitamin D Deficiency, Gastrointestinal Diseases
Ultraviolet Light And Vitamin D In Subjects With Fat Malabsorption Or After Gastric Bypass Surgery
Patients with fat malabsorption due to Crohn's disease, ulcerative colitis, or other causes including cystic fibrosis, among others, or who have undergone gastric bypass have increased incidence of vitamin D deficiency relative…
- Trial name
- NCT01910792
- Testing
- Sperti Lamp
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Boston University
Colorectal Neoplasm, Colorectal Cancer
New Individualized Therapy Trial for Metastatic Colorectal Cancer
The purpose of this study is to evaluate the safety and tolerability of imatinib mesylate in combination with panitumumab for the treatment of stage IV colorectal cancer that has spread to the liver.
- Trial name
- NITMEC (NCT00867334)
- Testing
- Imatinib mesylate and panitumumab, Standard-of-care treatment with panitumumab
- Where
- 2 sites in United States
- Volunteers
- 10 people
- Sponsor
- Inova Health Care Services
Non Small Cell Lung Cancer, Urothelial Carcinoma
Arginase-1 Peptide Vaccine in Patients With Metastatic Solid Tumors
In this phase I first-in-humans-study a vaccine consisting of arginase-1 (ARG1) peptides and the adjuvant Montanide ISA-51 will be tested in ten patients with metastatic solid tumors.
- Conditions
- Non Small Cell Lung Cancer, Urothelial Carcinoma, Malignant Melanoma, Ovarian Cancer
- Trial name
- NCT03689192
- Testing
- ARG1-18,19,20
- Where
- Denmark
- Volunteers
- 13 people
- Sponsor
- Herlev Hospital
Non-alcoholic Fatty Liver Disease
Helicobacter Pylori Eradication in Diabetic Subjects With Non-alcoholic Fatty Liver Disease
The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass…
- Trial name
- NCT01712711
- Testing
- H.pylori eradication
- Where
- Iran
- Volunteers
- 40 people
- Sponsor
- Tehran University of Medical Sciences
Oropharyngeal Dysphagia
Design and Implementation of a Nutritional Intervention in Patients With Oropharyngeal Dysphagia
The purpose of this trial is to design, implement and evaluate the effect of a nutritional intervention in patients with Oropharyngeal Dysphagia on body composition and oral intake of energy and protein.
- Trial name
- NCT02959450
- Testing
- Modified consistency and volume diet
- Where
- Mexico
- Volunteers
- 127 people
- Sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Hepatitis, Hepatitis C
Algeron (Cepeginterferon Alfa-2b) Compared With PegIntron (Peginterferon Alfa-2b) for Treatment of Chronic Hepatitis C
The purpose of the study is to demonstrate the noninferiority of Algeron 1.5 and 2.0 μg/kg/week in combination with ribavirin compared to PegIntron in combination with ribavirin in the treatment of chronic hepatitis C, and to…
- Trial name
- NCT01740089
- Testing
- Algeron, PegIntron, Ribavirin
- Where
- Russia
- Volunteers
- 150 people
- Sponsor
- Biocad
Alcoholic Hepatitis
A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis
This is a research trial testing DUR-928 (an experimental medication). The purpose of this trial is to assess the dose related safety, Pharmacokinetics, and Pharmacodynamics of DUR 928 in patients with moderate and severe…
- Trial name
- AH (NCT03432260)
- Testing
- DUR-928 30 mg, DUR-928 90 mg, DUR-928 150 mg
- Where
- 7 sites in United States
- Volunteers
- 19 people
- Sponsor
- Durect
HCC, Liver Cancer
A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver
The primary question of interest is quantifying the relationship between Y-90 liver therapy and liver damage. Little is known on this subject.
- Trial name
- NCT02966223
- Testing
- MRI and HIDA scan
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Indiana University
Hepatocellular Carcinoma
Trial of TRC105 and Sorafenib in Patients With HCC
The purpose of the phase 1b portion is to evaluate safety and tolerability and determine a recommended phase 2 dose for TRC105 when added to standard dose sorafenib in patients with hepatocellular carcinoma.
- Trial name
- NCT02560779
- Testing
- Carotuximab (TRC105), Sorafenib
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Tracon Pharmaceuticals Inc.
Irritable Bowel Syndrome
Effects of Low FODMAP Diet on Colonic Epithelial Physiology in Diarrhea-predominant Irritable Bowel Syndrome
This research is studying whether changing an individual's diet may have an impact as a treatment or outcome for Irritable Bowel Syndrome (IBS).
- Trial name
- NCT04542018
- Testing
- a low FODMAP diet for 4 weeks
- Where
- 2 sites in United States
- Volunteers
- 48 people
- Sponsor
- University of Michigan
Inoperable Locally Advanced or Metastatic Biliary Tract Cancer
Selumetinib (AZD6244, ARRY-142886) J-BTC Phase 1 Study
The objective of this study is to investigate the safety and tolerability of oral dose of selumetinib in combination with chemotherapies (cisplatin and gemcitabine) in Japanese patients with advanced biliary tract cancer (BTC).
- Trial name
- NCT01949870
- Testing
- Cisplatin, Gemcitabine, Selumetinib
- Where
- 2 sites in Japan
- Volunteers
- 6 people
- Sponsor
- AstraZeneca
Acute Liver Failure, Fulminant Hepatic Failure
Safety and Efficacy of the ELAD System (ELAD) to Treat Acute Liver Failure (ALF)
This phase 2 study is developed to evaluate the effect of ELAD on overall survival (OS) in subjects with acute liver failure (ALF) compared to matched historical controls.
- Conditions
- Acute Liver Failure, Fulminant Hepatic Failure, Primary Graft Non-Function, Surgically-Induced Liver Failure
- Trial name
- NCT01875874
- Testing
- ELAD
- Where
- 18 sites in United States
- Volunteers
- 8 people
- Sponsor
- Vital Therapies, Inc.
Hepatitis C, Chronic
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI 207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically infected HCV GT1b treatment naïve patients…
- Trial name
- NCT01728324
- Testing
- Ribavirin: 24-week treatment, BI 207127: 24-week treatment, Faldaprevir: 24-week treatment
- Where
- 109 sites in United States, Australia and 10 more
- Volunteers
- 496 people
- Sponsor
- Boehringer Ingelheim
Esophageal and Gastric Varices
Carvedilol as an Adjunct to Endoscopic Cyanoacrylate Injection for Secondary Prophylaxis of Gastric Variceal Bleeding
Gastric variceal obturation is the current endoscopic therapy of choice for gastric variceal bleeding but is associated with a high rebleeding rate. Carvedilol is a potent non-selective β-blocker.
- Trial name
- NCT02504723
- Testing
- carvedilol, cyanoacrylate
- Where
- Taiwan
- Volunteers
- 121 people
- Sponsor
- Kaohsiung Veterans General Hospital.
Head and Neck Cancer, Dysphagia
Clinical Impact of Respiratory-Swallow Training on Refractory Dysphagia in Oropharyngeal Head and Neck Cancer
Veterans following treatment of head and neck cancer can be left with lasting swallowing impairment that may require diet alterations, need for feeding tubes, and risk of pneumonia.
- Trial name
- NCT03377270
- Testing
- Respiratory Swallow Training
- Where
- 2 sites in United States
- Volunteers
- 49 people
- Sponsor
- VA Office of Research and Development
Hepatocellular Carcinoma (HCC)
A Study of Tislelizumab Versus Sorafenib in Participants With Unresectable Hepatocellular Carcinoma (HCC)
This Phase 3 study was a global, multicenter trial that randomly assigned participants to either tislelizumab or sorafenib as a first-line treatment for adults with advanced liver cancer (hepatocellular carcinoma) that could not…
- Trial name
- NCT03412773
- Testing
- Tislelizumab, Sorafenib
- Where
- 122 sites in United States, China and 9 more
- Volunteers
- 684 people
- Sponsor
- BeiGene
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF2 (NCT00104520)
- Testing
- AZLI 75 mg two times a day (BID)/three times a day (TID)
- Where
- 56 sites in United States
- Volunteers
- 211 people
- Sponsor
- Gilead Sciences
Carcinoma, Hepatocellular, Liver Metastases
Study to Evaluate VORTX Rx (Theresa)
Multi-center, Open-labeled, Non-randomized Study to Evaluate the Acute Technical Performance and Safety Profile of the VORTX Rx® for Ablation of Primary and Metastatic Liver Tumors
- Trial name
- Theresa (NCT03741088)
- Testing
- VORTX Rx treatment
- Where
- 3 sites in Spain
- Volunteers
- 8 people
- Sponsor
- HistoSonics, Inc.
Colitis, Ulcerative
An Efficacy and Safety Study of Vedolizumab Intravenous (IV) Compared to Adalimumab Subcutaneous (SC) in Participants With Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of vedolizumab intravenous (IV) treatment compared to adalimumab subcutaneous (SC) treatment over a 52-week treatment period.
- Trial name
- NCT02497469
- Testing
- Vedolizumab, Adalimumab
- Where
- 330 sites in United States, Argentina and 32 more
- Volunteers
- 771 people
- Sponsor
- Takeda
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