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Search Results Within Category "Digestive & Liver Health "

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20 Study Matches

Tissue Collection and Characterization: Longitudinal Senescence Analysis

The purpose of this study is to better understand the makeup and composition of blood and fat tissue in people with a variety of health conditions. We are specifically interested in identifying and characterizing a specialized state of cells called senescence. This is when cells in our body stop dividing, but still produce inflammatory signals in the body. Senescent cells have been linked to a variety of metabolic diseases related to inflammation. We are collecting fat tissue and blood samples to look for genes that are associated with inflammation and senescence. These samples will be collected from healthy people as well as people with different metabolic diseases, who are already undergoing ENT surgery as part of their care at the University of Minnesota, to find meaningful patterns that can help lead to better treatments.

Sayeed Ikramuddin
18 years and over
This study is also accepting healthy volunteers
STUDY00021497
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Inclusion Criteria:

• undergoing abdominal or ENT surgical procedure with general anesthesia
• laparoscopic procedures including cholecystectomy, bariatric surgery, hernia repair (incisional or hiatal) in which the liver is accessible, esophageal surgery, or GI reconstruction
Exclusion Criteria:

• women who are pregnant or breast feeding
Digestive & Liver Health
Clinics and Surgery Center (CSC), abdomen, anesthesia, ENT surgery, surgery
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A novel partial-enteral nutrition protocol to improve nutrition status of adult patients experiencing a Crohn's disease flare and starting new immunologic therapy

The purpose of this study is to evaluate if a partial enteral nutrition diet, with a pea protein plant-based oral nutrition supplement (ONS; Kate Farms Peptide 1.5), combined with the Inflammatory bowel disease - Anti-Inflammatory Diet (IBD-AID) improves the nutritional intake of adult patients experiencing a CD flare initiating immunologic therapy compared to standard of care. Standard of care for patients experiencing a CD flare is commonly characterized by prescription of a low fiber diet and either lack of oral nutrition supplementation or use of an animal protein based supplement.

Byron Vaughn
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013936
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Inclusion Criteria:

• 18 years and older
• diagnosis of moderate to severe Crohn's Disease (CD) as defined by physician
• starting new advanced therapy
Exclusion Criteria:

• short bowel syndrome
• ileostomy or colostomy
• use of pre or probiotic supplements within last 14 days
• active implanted medical devices (cardiac pacemaker, defibrillator)
• pregnancy
• other serious medical conditions (study staff will review)
Digestive & Liver Health
Crohn's Disease (CD)
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RCT01437: Proactive infliximab optimization using a pharmacokinetic dashboard versus standard of care in patients with inflammatory bowel disease: The OPTIMIZE Trial

The purpose of this study is to find out if using a computer program (called iDose) to guide infliximab dosing is more effective and safer than using standard infliximab dosing over 52 weeks. All patients in this study will be receiving infliximab as part of their medical care, this study is only looking at two different methods of determining the dose and timing of administration.

Byron Vaughn
Not specified
This study is NOT accepting healthy volunteers
STUDY00013632
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Inclusion Criteria:

• 16 to 80 years of age
• diagnosis of moderate to severe Crohn's disease (CD) or Ulcerative colitis
• physician intends to prescribe infliximab for treatment
• have not previously taken infliximab
Exclusion Criteria:

• pregnant or breastfeeding
• complications of inflammatory bowel disease (IBD) such as abscess, need for ostomy (study staff review)
• current infection in last 6 months
• other significant medical conditions (heart, lungs, liver, endocrine etc.)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Crohn's disease
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See this study on ClinicalTrials.gov

Advancing Liver Therapeutic Approaches (ALTA). The ALTA Consortium Study Group for the management of portal hypertension A 5-year longitudinal observational study of patients with cirrhosis undergoing TIPS placement

The goal of this study is to collect information about patients undergoing a TIPS and to evaluate the longterm outcomes and complications over a 5-year period. There are no expected direct benefits to participation in this study however knowledge gained from this research may beneficial to future patients undergoing this procedure. This study does not involve any investigational drugs.

Nicholas Lim
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014403
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Inclusion Criteria:

• at least 18 years old
• scheduled to undergo a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure
Exclusion Criteria:

• women who are pregnant
• undergoing TIPS placement as part of an investigational study
Digestive & Liver Health
Clinics and Surgery Center (CSC), Cirrhosis, Liver Cirrhosis, Transjugular Intrahepatic Portosystemic Shunt (TIPS)
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REST-PSLL: Re-engineering Surgical Recovery and Transitions Using Technology Patient Safety Learning Laboratory

We are conducting this research to: better understand barriers and facilitators of successful at-home care after an emergency laparotomy (EL) surgical procedure, create technology solutions for EL patient recovery tools to support at-home care and evaluate the success of the new at-home care tools. Participation includes a video-recorded or audio-recorded interview, either in person or virtual, with a study team member. The interview questions will ask about various topics related to the post-surgical experience. Prior to the interview, participants will also be asked to complete a 30-minute survey to help the study team prepare for the interview. Additionally, if a participant is having ongoing post surgery complications, they may be invited to opt-in to a second 60-minute interview.

Genevieve Melton-Meaux
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020064
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Inclusion Criteria:

• Emergency abdominal (laparotomy) surgery within the past 6 months
Exclusion Criteria:

• Emergency laparotomy surgery for only gallbladder or appendix removal.
Digestive & Liver Health
Emergency abdominal surgery, abdominal injury, emergency, stomach, small intestine, colon
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Hepatic Energy Fluxes, NASH, and Vertical Sleeve Gastrectomy

This study is looking at the liver function of people who have bariatric surgery. People who want to be in this trial must be obese, have abnormal liver function tests & prediabetes or type 2 diabetes. The study includes assistance with diet and exercise for a year after surgery.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00006269
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Inclusion Criteria:

• age 18 to 67 years
• diagnosis of non-alcoholic steatohepatitis (NASH)
• Body Mass Index (BMI) 30.0-55.0 kg/m2
• willing to have surgical treatment and have insurance with no exclusion for obesity related treatments or management of obesity surgery complications
• live or work within approximately three-hour traveling time from the study clinic for the duration of the one-year trial
Exclusion Criteria:

• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Bariatric surgery, NASH, fatty liver, gastrectomy, gastric sleeve, sleeve, sleeve, VSG, weight loss
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See this study on ClinicalTrials.gov

Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

This study is comparing the treatment of Non-Alcoholic Steatohepatitis (NASH) with either lifestyle changes or obesity surgery with lifestyle changes.  Participants must be 30-70 years old, have a BMI of 35.0-60.0 kg/m2, have health insurance that will pay for obesity surgery, and be willing to accept either treatment.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00014879
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Inclusion Criteria:

• ages 30 to 70 years
• diagnosed with NASH with a total NAS >=4 including a ballooning score of at least 1, or diagnosed with T2DM or prediabetes, HbA1c < 9% Body Mass Index (BMI): 35.0-50.0 kg/m2
• willing to accept either surgery or life style changes
• must have insurance with no exclusion for obesity related treatments or management of obesity surgery complications. applies to all participants enrolled in the study
• evidence of liver fat present in the baseline MR images
• suitable for liver biopsy
Exclusion Criteria:

• cardiovascular event (myocardial infarction, acute coronary syndrome, coronary artery angioplasty or bypass, stroke) in the past six months
• pulmonary embolus or thrombophlebitis in the past six months
• cancer diagnosis unless disease free for five years
• alcohol intake more than one drink per day
• other physical or mental health disease (study staff will review)
Digestive & Liver Health
Bariatric Surgery, NASH, VSG, Clinics and Surgery Center (CSC), fatty liver, gastrectomy, sleeve, sleeve gastrectomy, weight loss
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See this study on ClinicalTrials.gov

GLNE 007 Evaluation of Stool Based Markers for the Early Detection of Colorectal Cancers and Adenomas

The purpose of this study if to determine if stool or blood can be used to detect colon cancers as early or earlier than colonoscopy. The researchers plan to use these samples to learn about specific proteins (also known as biomarkers) that may indicate colon polyps, colon cancer or an increased risk of developing colon cancer. In order to learn more about preventing and detecting colon and rectal cancer, we are collecting samples from subjects with cancer, adenomas, and colonoscopies who may be at risk for polyps.

Paolo Goffredo
18 years and over
This study is also accepting healthy volunteers
SITE00001813
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Inclusion Criteria:

• at least 18 years old
• able to tolerate giving a blood specimen of up to 60 cc
• willing to collect 1-2 stool samples and prepare a Fecal Immunochemical Test (FIT)
• people who have untreated colon cancer OR have previously removed adenomas, OR have a family history of colon cancer OR have a current positive screening stool test in the past 12 months that hasn't been evaluated
• Healthy Controls: have no history of finding polyps, no family history, or negative colorectal cancer screening test (if performed) within past 12 months
Exclusion Criteria:

• people who have had surgery, radiation, or chemotherapy for their current colorectal cancer or any other cancer
• history or clinically active Inflammatory Bowel Disease
• HIV or chronic active viral hepatitis
• history of cancer in the past 3 years (except minor skin, cervical, or endometrial)
• active chemotherapy or radiation treatment for any purpose
Cancer, Digestive & Liver Health
Colon Cancer, Colon Cancer, Colon Cancer Screening, Colorectal Cancer
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Liver Collection Study

This is a study of individuals older than 18, undergoing abdominal procedures in which the liver is accessible, and are amenable to liver samples being collected during their surgical procedure, with the option to participate in a specialized scan that can provide information on liver health, stiffness, and fat content. This study is trying to figure out how senescent (aging) cells in the liver are related to an individual's health status and better understand the association between these cells and different metabolic diseases.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00013764
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Inclusion Criteria:

• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
Exclusion Criteria:

• Pregnancy or nursing
• Physician may exclude
Diabetes & Endocrine, Digestive & Liver Health, Prevention & Wellness
abdominal surgery, liver biopsy
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Profiling of Adipose Tissue Depots and Immune Correlates

This is a study of individuals older than 18, undergoing abdominal surgery, and are amenable to fat samples being collected during their surgical procedure, with the option to participate in other tests that can provide information on insulin sensitivity and fat distribution. This study is trying to figure out how fat tissue is related to an individual's health status and health conditions, and the analysis of the aging of cells that make up the human body.

Sayeed Ikramuddin
18 years and over
This study is NOT accepting healthy volunteers
STUDY00009134
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Inclusion Criteria:

• Age 18 years or older
• Undergoing abdominal surgical procedure with general anesthesia
Exclusion Criteria:

• Pregnancy or nursing
• Exclusion at the discretion of attending physician or Eligibility Committee
Digestive & Liver Health, Diabetes & Endocrine, Prevention & Wellness
abdominal surgery, fat collection
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A 52-week, Double-blind, Placebo-controlled, Randomized, Phase 3 study Intended to Determine the Effects of seladelpar on normalization of Alkaline phosphatase Levels in Subjects with Primary Biliary Cholangitis (PBC) and an Incomplete Response or Intolerance to Ursodeoxycholic Acid (UDCA) (IDEAL)

The purpose of this research study is to determine if seladelpar (study drug) is effective at normalizing the disease marker alkaline phosphatase in subjects with PBC who are currently on ursodeoxycholic acid (UDCA) treatment or intolerant to UDCA. This will be done by looking at changes in blood tests. This research study is also measuring whether seladelpar makes itching (pruritus) better. This will be done using information about itching that subjects enter on a device or app on their phone.

Mary Thomson
18 years and over
This study is NOT accepting healthy volunteers
STUDY00020794
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Inclusion Criteria:

• 18 to 75 years old
• taking Ursodeoxycholic Acid (UDCA) for 12 months prior to screening (with stable dose for more than 3 months before starting the study) OR unable to take UDCA (last dose of UDCA greater than 3 months before starting the study)
• study staff will review additional inclusion and exclusion criteria
Exclusion Criteria:

• other chronic liver diseases
• drinking more than 2 drinks per day in women and 3 drinks per day in men, or unable to quantify alcohol intake reliably
• history of cancer diagnosed or treated, active or within 2 years, or ongoing evaluation for cancer; squamous or noninvasive basal cell skin cancers and cervical carcinoma in situ are allowed (if treated)
• women who are pregnant or plan to become pregnant, or are breastfeeding
Digestive & Liver Health
Clinics and Surgery Center (CSC), Primary Biliary Cholangitis
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Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies

This study will provide the most accurate and reliable estimates to date on disease progression and clinical events in evolving chronic pancreatitis. We also hope to develop from the results of this study some lab tests that will help us with early diagnosis of chronic pancreatitis and also to discover any genetic factors that may affect your chances of developing chronic pancreatitis.

Melena Bellin
18 years and over
This study is NOT accepting healthy volunteers
SITE00001159
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Inclusion Criteria:

• diagnosis of chronic pancreatitis.
Exclusion Criteria:

• N/A
Digestive & Liver Health
Chronic Pancreatitis, Pancreatitis
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See this study on ClinicalTrials.gov

ELEVATE, a global observational longitudinal prospective registry of patients with acute hepatic porphyria (AHP) (ELEVATE)

This is a global, multicenter, prospective, observational, longitudinal registry conducted to characterize the natural history and real-world clinical management of patients diagnosed with AHP. This protocol will not recommend the use of any specific treatments, visits, or procedures. No medication is provided as part of registry participation.

Gregory Vercellotti
12 years and over
This study is NOT accepting healthy volunteers
SITE00001194
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Inclusion Criteria:
* Documented diagnosis of AHP, per physician's determination
Exclusion Criteria:
* Currently enrolled in a clinical trial for any investigational agent
Digestive & Liver Health, Rare Diseases
Clinics and Surgery Center (CSC)
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Diabetes RElated to Acute pancreatitis and its Mechanisms (DREAM) (DREAM)

The purpose of this research study is to find out how many people with acute pancreatitis develop diabetes. Risk factors for diabetes and the types of diabetes that occur after acute pancreatitis will also be studied. A small number of people who already had diabetes before their acute pancreatitis attack will be enrolled for comparison.

Melena Bellin
18 years and over
This study is NOT accepting healthy volunteers
SITE00001256
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Inclusion Criteria:

• diagnosis of acute pancreatitis no more than 90 days ago
Exclusion Criteria:

• definite diagnosis of chronic pancreatitis based on results of scans (study staff will review)
• pancreas tumors
• prior surgery on the pancreas
• pregnancy
• other significant health problems, study staff will review
Diabetes & Endocrine, Digestive & Liver Health
Diabetes, Pancreatitis, Pancreas
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A Randomized Trial of Intra-Portal Alone Versus Intra- and Extra- Portal Transplantation of Pancreatic Islets After Total Pancreatectomy for Chronic Pancreatitis (iSite)

One treatment for certain types of chronic pancreatitis is total pancreatectomy with islet autotransplantation (TPIAT). In this procedure, the pancreas is removed (eliminating the source of the pain) and the islets, which produce insulin and other important hormones, are taken from the pancreas and transplanted in to the liver. This is a small study to evaluate a new procedure for transplanting some islets to a new location in the body.

Gregory Beilman
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003956
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Inclusion Criteria:

• age 18- 68
• scheduled for a total pancreatectomy and IAT at University of Minnesota
Exclusion Criteria:

• diabetes mellitus fasting blood glucose greater than 115mg/dl, or hemoglobin A1c level greater than 6.0%
• use of any of the following treatments in the 30 days prior to enrollment: insulin, metformin, sulfonylureas, glinides, thiazolidinediones, GLP-1 agonists, DPP-4 inhibitors, or amylin
• other medical or mental health diagnosis (study staff with review)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Chronic Pancreatitis, Diabetes Mellitus, Islet Cell Transplantation
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A Minimal-Risk, Multi-Center, Prospective, Clinical Trial to Evaluate the PrevisEA Device for Predicting Gastrointestinal Impairment

This device listens to and records abdominal sounds, which provides data that can help predict gastrointestinal impairment (GII). GII is a condition that is defined as the failure of oral re-feeding after abdominal surgery. This happens when any of the following events happen beyond 24-hours after abdominal surgery; vomiting, need to reverse the diet, or need to place a nasogastric (NG) tube.

Wolfgang Gaertner, MD
18 years and over
This study is NOT accepting healthy volunteers
STUDY00012967
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Inclusion Criteria:

• 18 to 90 years of age
• having an elective intestinal resection surgery (specific types, study staff will review)
Exclusion Criteria:

• allergy to skin adhesive
• unable to have device applied to the skin on the abdomen
• evidence of infection before surgery, including a deep wound infection or urinary tract infection
• specific types of surgery (study staff will review)
Digestive & Liver Health
Clinics and Surgery Center (CSC), Bowel surgery
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Impact of Inflammatory Bowel Disease and IBD-related Surgery on Female Fertility: A Prospective Registry

This is a prospective questionnaire study that will examine the impact of IBD and its surgical treatments on fertility in women with IBD of reproductive age (18-45). Women with IBD who are attempting to get pregnant within the next year will answer questionnaires about their general, surgical and reproductive health, conception history and sexual partner information. This will help identify risk factors predictive of fertility outcomes and early fetal loss, determine time to conception, and assess efficacy of fertility services including in vitro fertilization.

Eugenia Shmidt
18 years and over
This study is NOT accepting healthy volunteers
STUDY00003958
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Inclusion Criteria:

• age 18-45 years
• diagnosis of inflammatory bowel disease (IBD)
• not currently pregnant or trying to get pregnant
• desire to become pregnant within the next 12 months (may become pregnant while in the study)
Exclusion Criteria:

• prior pelvic surgery, including surgery of the cervix, ovary, uterus or fallopian tubes
• known female sterility
• known male infertility factors in partner
Digestive & Liver Health, Women's Health
Fertility, IBD, Inflammatory Bowel Disease
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SpHincterotomy for Acute Recurrent Pancreatitis (SHARP) Trial (SHARP)

We are studying the effectiveness of a new procedure to treat people who have episodes of acute pancreatitis with pancreas divisum. Of the participants, half will receive the new procedure called endoscopic retrograde cholangiopancreatography (ERCP) with minor papilla endoscopic spincterotomy (miES) the other half with receive only ERCP. We will monitor outcomes for at least eighteen months.

Martin Freeman
18 years and over
This study is NOT accepting healthy volunteers
SITE00000387
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Inclusion Criteria:

• at least 18 years old
• two or more episodes of acute pancreatitis, with one occurring in the last 24 months
• there is no certain explanation for recurrent acute pancreatitis
Exclusion Criteria:

• prior minor papilla therapy (endoscopic or surgical)
• other causes of pancreatitis (study staff will review)
• regular use of opioid medication for abdominal pain for the past three months
Digestive & Liver Health
Clinics and Surgery Center (CSC), ERCP, Pancreatitis
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Characterization of spleen motion and anatomy using imaging and sensors

This research is being performed to examine how the spleen moves during breathing in various body positions and breathing conditions. Physical measurements of the participant's body will be recorded (weight, height, and body dimensions) and then noninvasive recordings of the spleen and breathing patterns will be recorded. The spleen motion will be measured using standard abdominal ultrasound imaging, and breathing will be measured with accelerometers (small devices about the size of a quarter that measure the movement of the chest during breathing).

Hubert Lim
18 years and over
This study is also accepting healthy volunteers
STUDY00013252
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Inclusion Criteria:

• at least 18 years old
Exclusion Criteria:

• individuals who have had a splenectomy
• people with breathing difficulties and/or individuals for whom short breath holds and modification of breathing patterns is difficult or uncomfortable
• unable to maintain five body positions: sitting, sitting with a 45 degree recline, laying on back (supine), laying on right side, and laying face down (prone) comfortably and independently
• unable to speak and read English
Digestive & Liver Health
Imaging, Spleen
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Corrona Inflammatory Bowel Disease (IBD) Registry

This is a prospective, non-interventional, research study for patients with IBD under the care of a certified gastroenterologist. The primary objective for this registry is to prospectively study the natural history of IBD, the prevalence and incidence of comorbidities, targeted adverse events, and more, via questionnaires.

Byron Vaughn
18 years and over
This study is NOT accepting healthy volunteers
STUDY00007736
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Inclusion Criteria:

• at least 18 years old
• Diagnosis of one of the following by a gastroenterologist: Crohn's disease or Ulcerative colitis (UC)
• users of an approved biologic drug or JAK inhibitor (Tofacitinib) for the treatment of UC or Crohn's disease
Exclusion Criteria:

• Participating in or planning to participate in a clinical trial studying new medications for Crohn's disease or Ulcerative colitis
Digestive & Liver Health
Clinics and Surgery Center (CSC), Crohn's disease, Ulcerative colitis
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See this study on ClinicalTrials.gov