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Suggestions within category "Digestive Systems & Liver Disease"


Study matches: 10

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.


A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-494 for Induction and Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

This study is for patients who have been diagnosed with moderate to severe ulcerative colitis (UC) who are experiencing bloody diarrhea, abdominal pain, and a sudden and constant feeling of needing to move their bowels. Additionally, patients have been unable to tolerate or have had an insufficient response to treatment with medications that help reduce inflammation associated with UC. This research is being done to evaluate the safety of different doses of ABT-494 (study medication) and determine how well it works, as well as how the study medication is absorbed, distributed and eliminated in the body over time.
Amy Behe at abehe@pennstatehealth.psu.edu or 814-689-0014
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Diagnosis of ulcerative colitis for at least 90 days
Demonstrated an inadequate response to, loss of response to, or intolerance to steroids, immunosuppressants and/or biologic therapies
Exclusion Criteria:
Have a current diagnosis of Crohn's disease, fulminant colitis and/or toxic megacolon
History of total colectomy or ileostomy
Taking a probiotic and has not been on a stable dose for at least 10 days
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NCT02819635
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State College, PA

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

The primary objective of this multicenter non-interventional Registry is to evaluate the long-term safety of HUMIRA in moderately to severely active UC adult patients who are treated as recommended in the local product label.
Amy Behe at abehe@pennstatehealth.psu.edu or 814-689-0014
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Ulcerative Colitis
On Humira/Imuran or 6-MP
IBD
Exclusion Criteria:
Indeterminate Colitis
Crohn's Disease
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NCT01848561
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State College, PA

FLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis

The primary objective of the study is to evaluate the safety and effectiveness of APT-1011 in adults with eosinophilic esophagitis (EoE). The study will also look at how long the study drug takes to get into the blood circulation, the length of time that it stays in the blood, and how it is broken down and processed by the body, which is known as “pharmacokinetics” (PK).
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 7175315226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Have a diagnosis of Eosinophilic Esophagitis
Have 3 or more episodes of dysphagia (difficulty with food going down)
Be compliant with daily completion of the electronic diary
Exclusion Criteria:
Known sensitivity/intolerance to steroids
Presence of and oral/esophageal infection
Have any mouth or dental condition that prevents normal eating
Have recent history of gastrointestinal bleeding
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NCT03191864
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Location
Hershey, PA

Characterization of the effects of amino acid/electrolyte based beverages on hydration status in young and older subjects

There are many beverages are commercially available on the market. Some beverages have glucose that may impact how long they maintain hydration status. New commercially available beverages are amino acid-based and may be more beneficial in maintaining hydration. The goal of this study is to compare an amino acid-based beverage on its ability to maintain hydration status relative to other commercially available products in both younger and older individuals.
Megan Clarke at mmc40@psu.edu
All
18 year(s) or older
This study is also accepting healthy volunteers
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Inclusion Criteria:
Men and women
18-30 years or ≥60 years of age
Regularly active
Healthy
Exclusion Criteria:
Cardiovascular, renal, or digestive diseases
Pregnancy or breastfeeding
Smoking and/or use of nicotine-containing products
Medications that alter fluid balance (e.g., diuretics)
Illegal/recreational drug use
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N/A
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Location
State College, PA

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)

This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of SEL in subjects with compensated cirrhosis due to NASH The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as GS-4997) can cause fibrosis regression and reduce associated complications in subjects with cirrhosis due to NASH. The secondary objective of this study is:  To assess the safety and tolerability of SEL in subjects with NASH and cirrhosis
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 7175315226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
NASH confirmed by liver biopsy, cirrhosis
HbA1c<9.5
Exclusion Criteria:
history of decompensated liver disease
HCV,HBV, HIV positive
current or history of HCC
current alcohol or drug abuse
liver transplant
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NCT03053063
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Location
Hershey, PA

GLNE 010: Validation and Comparison of Biomarkers for the Early Detection of Colorectal Adenocarcinoma

The purpose of this study is to see if stool, urine or blood can be used to find colon cancer as early or earlier than colonoscopy can. The researchers want to use these samples to learn about specific proteins or genes (also called biomarkers) that may indicate if someone has colon polyps (pre-cancer), colon cancer, or an increased risk for developing colon cancer. The researchers are part of a National Cancer Institute program called the Early Detection Research Network (EDRN). We have some biomarkers that are very promising, so we are testing them (“validating them”) in this study.
Jessica Wright at jwright3@pennstatehealth.psu.edu or 284713
All
18 year(s) or older
This study is also accepting healthy volunteers
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Inclusion Criteria:
Scheduled for colonoscopy in the next 4 months
60 years of age and older
able to tolerate removal of 5 tubes (3.5 tablespoons) of blood
willing to provide blood, urine and stool samples
Exclusion Criteria:
positive stool blood test (FIT/FOBT) in the past year
ever had colon or rectal cancer
history of inflammatory bowel disease
confirmed hereditary non-polyposis colorectal cancer, familial adenomatous polyposis, HIV or chronic viral hepatitis
cancer diagnosis or treatment in past year
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NCT01511653
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Location
Hershey, PA

A Phase 3, randomized, double-blind, placebo-controlled, multicenter study to investigate the efficacy and safety of Mongersen (GED-301) for the treatment of subjects with active Crohn’s disease.

This is a drug study, that will examine an experimental medication GED-0301 (mongersen) in patients who have active Crohn's disease.
Amy Behe at abehe@pennstatehealth.psu.edu or 814-689-0014
All
18 year(s) or older
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
18 years or older
Diagnosis of Crohn's for at least 3 months
Current symptoms of a flare.
Have been on a least one medication for Crohn's disease.
IBD
Exclusion Criteria:
Diagnosis of ulcerative colitis or indeterminate colitis.
Surgery indicated.
Ileostomy or Colostomy.
Pregnant or breastfeeding.
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NCT02596893
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State College, PA

A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

This is a study comparing pancreaze, an approved pancreatic enzyme used to treat pancreatic insufficiency in patients who have cystic fibrosis, to a new study drug enzyme that's in a liquid formulation and is not derived from pig pancreas.
Diane Kitch at dkitch@pennstatehealth.psu.edu or 717-531-5646
All
Not specified
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Must have Cystic Fibrosis and Pancreatic Insufficiency
Must be taking same dose of enzymes for the past 30 days
Have stable nutritional status
Be able to swallow capsules
Exclusion Criteria:
Not taking Pancreaze as an enzyme
Unstable liver or kidney tests
May not have a G-tube
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N/A
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Location
Hershey, PA

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of SEL in subjects with NASH and bridging (F3) fibrosis. The primary objective of this study is:  To evaluate whether selonsertib (SEL, previously known as GS- 4997) can cause fibrosis regression and reduce progression to cirrhosis and associated complications in subjects with NASH and bridging (F3) fibrosis. The secondary objective of this study is:  To assess the safety and tolerability of SEL in subjects with NASH and bridging (F3) fibrosis.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 17175315226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
NASH confirmed by liver biopsy, no cirrhosis
HbA1c<9.5
Exclusion Criteria:
prior history of decompensated liver disease
HIV infection
HEP B or C
history of liver transplant
current or history of HCC
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NCT03053050
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Location
Hershey, PA

A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis (NASH)

This Phase 3, double-blind, randomized, long-term, placebo-controlled, multicenter international study will evaluate the effect of OCA on histological improvements in NASH, all-cause mortality, and liver-related clinical outcomes. Primary Objective Assessed at 18 Months • To evaluate the effect of OCA compared to placebo on histological improvement in NASH by assessing the following as co-primary endpoints using NASH CRN scoring criteria: − Improvement in fibrosis by at least 1 stage with no worsening of NASH defined as no increase in hepatocellular ballooning or lobular inflammation Page 33 of 261 Protocol 747-303 Version 4: 14 Apr 2016 Page 34 Confidential and Proprietary − Resolution of NASH as defined by overall histopathological interpretation with no worsening of fibrosis 6.2. Secondary Objectives Assessed at 18 Months • To evaluate the effect of OCA compared to placebo on histological improvement in NASH by assessing the following using NASH CRN scoring criteria: − Improvement of fibrosis and NASH as a composite endpoint and as defined by improvement in fibrosis by at least 1 stage and improvement in NAFLD activity score (NAS) by at least 2 points with at least 1 point improvement each for hepatocellular ballooning and lobular inflammation − Resolution of fibrosis − Improvement in NAS by at least 2 points with no worsening of fibrosis − Improvement in each key histological feature of NASH by at least 1 point (steatosis, lobular inflammation, and hepatocellular ballooning)
laurie peiffer at lpeiffer@pennstatehealth.psu.edu or 7175315226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
NASH
fibrosis stage 2 or 3
stable body weight
Exclusion Criteria:
cirrhosis
prior cancer
heptocellular cancer
hiv, hcv, hbv
hba1c>9.5
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NCT02548351
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Location
Hershey, PA