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Gastroenterology and Hepatology Clinical Trials

The following searchable list includes all the Division of Gastroenterology and Hepatology, Department of Medicine clinical trials currently looking for participants. Please feel free to contact us with inquiries about any of our ongoing research.

Trials

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)

A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)…
A Long-Term Non-Interventional Registry to Assess Safety and Effectiveness of HUMIRA® (Adalimumab) in Patients with Moderately to Severely Active Ulcerative Colitis (LEGACY)
Hanauer, Stephen BHanauer, Stephen B
  • Map it 201 E. Huron St.
    Chicago, IL
NCT01848561 STU00094204
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Healthy Control Esophageal Registry and Biorepository

This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.…
This study is being done to compare how the esophagus and upper stomach work in people who have Scleroderma with symptoms of reflux disease or difficulty swallowing (dysphagia) to healthy controls. We will collect skin, esophageal and stomach biopsies (small pieces of tissue) to be used for several studies.
Must not be:
- Obese (i.e. BMI ≥30)
- Known medical illnesses that could affect esophageal function, gene expression or histology
- Have a diagnosis of an eating disorder
- Have a diagnosis of an autoimmune disease
- A current or previous smoker (smoked >100 cigarettes in lifetime)
- Have a history of alcohol abuse or addiction or score of 2 or higher on the CAGE questionnaire
- Taking antacids and/or proton pump inhibitors for heartburn
- Allergies to Fentanyl or Midolazam (sedatives used during endoscopy)
- Allergies to Lidocaine (Lidocaine anesthetic jelly used during manometry).
- Pregnant or nursing (hormones associated with pregnancy and lactation are known to affect esophageal function)
Carlson, Dustin AllanCarlson, Dustin Allan
STU00096856
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Semen quality in males with inflammatory bowel disease: Influence of medication for IBD

Semen quality in males with inflammatory bowel disease: Influence of methotrexate, ustekinumab and tofacitinib treatment.
  • Map it 201 E. Huron St.
    Chicago, IL
STU00201469
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Pathogenic Wnt-beta catenin target genes in macrophages and fibrosis

The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, …
The purpose of this study is to better understand the development of scleroderma-related lung fibrosis (ILD). We would like to investigate the role of macrophages and other important cells in the development of ILD. Macrophages are types of white blood cells important in the immune system. In healthy people, macrophages produce proteins that activate the immune system to assist in tissue repair. However, there is evidence that in people with scleroderma, the macrophages behave abnormally and contribute to scarring in the lungs.

Patients who participate in this study will:

  • donate fluid collected from their lungs during a bronchoscopy (taken at the time they are already scheduled to have a bronchoscopy or during their scheduled endoscopy)
  • give a blood sample
  • give esophageal biopsies (taken during their scheduled endoscopy)
  • as an option, give skin biopsies

  • At least 18 years old
  • Meet criteria for systemic sclerosis
  • Receive care at Northwestern Medicine in Rheumatology, Pulmonary & Critical Care, and/or Gastroenterology scleroderma clinics
  • Plan to undergo a standard of care bronchoscopy or endoscopy at Northwestern or a research bronchoscopy through a separate Northwestern study
Perlman, Harris RPerlman, Harris R
  • Map it 633 N. St. Clair St.
    Chicago, IL
STU00207083
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Northwestern TIPS Research Study

ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their …
ALTA is a multicenter consortium focused on the management of portal hypertension. ALTA TIPS is a longitudinal observational study of patients who are undergoing transjugular intrahepatic portosystemic shunt (TIPS) placement. ALTA will create a database that will provide clinical parameters and outcomes of patients undergoing TIPS as part of their standard of care in hopes of answering key clinical questions.

Undergoing a Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement

Subjects over the age of 18 able to provide consent or have a legally authorized representative to provide consent in the event the subject is unable to consent due to a transient clinical condition

Boike, Justin RichardBoike, Justin Richard
  • Map it 201 E. Huron St.
    Chicago, IL
NCT03973372 STU00208288
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TIPS
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Treatment for Pruitis in Primary Biliary Cholangitis (PBC).

Volixibat is an experimental treatment, meaning that it has not been approved by the US Food and Drug Administration (FDA) or any worldwide regulatory body. Volixibat is a medicine that lowers circulating bile acid levels (the amount of certain chemicals that are produced by the liver and are present in …

Volixibat is an experimental treatment, meaning that it has not been approved by the US Food and Drug Administration (FDA) or any worldwide regulatory body. Volixibat is a medicine that lowers circulating bile acid levels (the amount of certain chemicals that are produced by the liver and are present in the blood) that are believed to lead to the itching in patients with PBC. There are no other medicines approved to treat itching in patients with PBC.

  • Male or female, age ≥18 years
  • Primary Biliary Cholangitis
  • Pruitis
  • History of Elevated Alkaline Phosphatase
Boike, Justin RichardBoike, Justin Richard
  • Map it 675 N. Saint Clair St.
    Chicago, IL
NCT05050136 STU00218351
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Investigational drug for NASH cirrhosis

Treatment for subjects with NASH and cirrhosis

adults 18-75 year old with NASH and cirrhosis

Cheung, Amanda Ching-WunCheung, Amanda Ching-Wun
  • Map it 675 N. Saint Clair St.
    Chicago, IL
NCT05500222 STU00219506
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Measuring copper parameters in Wilson's Disease using a novel assay

The purpose of this study is to find out if a new test for patients with Wilson’s disease can accurately and reliably measure so-called free copper, also known as non-ceruloplasmin copper (NCC). Ceruloplasmin is a protein that helps transport copper from the liver and deliver copper to …

The purpose of this study is to find out if a new test for patients with Wilson’s disease can accurately and reliably measure so-called free copper, also known as non-ceruloplasmin copper (NCC). Ceruloplasmin is a protein that helps transport copper from the liver and deliver copper to the rest of your body to maintain your health. In Wilson’s disease, ceruloplasmin levels are low and free copper levels are higher than normal, which can be controlled by taking your Wilson’s disease medications regularly. There is currently no approved test to measure NCC. Your doctor may use a combination of tests including a blood test to measure ceruloplasmin in order to calculate the NCC, but this is not accurate or reliable. Having a more reliable and accurate measurement of NCC may help your doctor, in the future, make better informed decisions about your treatment, including the dose of your medicine.

Inclusion:

1. Willing and able to give informed consent for participation in the study

2. Male or female patients, aged 18 years or older as of signing the Informed Consent Form (ICF)

3. Able and willing to comply with study procedures and requirements, as judged by the treating physician

4. Established diagnosis of Wilson’s Disease (Leipzig score >4)

5. Either newly diagnosed or with elevated liver enzymes (defined as ALT, AST ≥1.5xULN) or 24-hour urinary copper excretion outside of recommended ranges [chelation range 200-500mcg/24 hr; zinc < 100mcg/24 hr]

6. Adequate venous access to allow collection of blood samples

Cheung, Amanda Ching-WunCheung, Amanda Ching-Wun
  • Map it 201 E. Huron St.
    Chicago, IL
NCT05783687 STU00219339
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