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Suggestions within category "Digestive Systems & Liver Disease"


Study matches: 14

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.
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.
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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Hershey, PA

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study of the Efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease

This study is for patients with moderately to severely active Crohn's disease who are experiencing symptoms such as diarrhea with or without blood, abdominal pain and/or a sudden and constant feeling that they have to move their bowels. Additionally, they may have been unable to tolerate or they may have had insufficient response to treatment with medications that help reduce the inflammation associated with their disease, such as corticosteroids, immunosuppressants and/or biologics. This research is being done to evaluate the safety of different doses of risankizumab and determine how well it works in patients with moderate to severe Crohn’s disease. Risankizumab is an investigational drug, which means that it has not been approved by the Food and Drug Administration (FDA) in the United States.
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:
Diagnosis of Crohn's disease > 3 months
Intolerance to aminosalicylates, oral steroids, systemic steroids, immunomodulators and/or biologics
Exclusion Criteria:
Diagnosis of ulcerative colitis or indeterminate colitis
Known complications of Crohn's disease (abscess, strictures, fulminant colitis, toxic megacolon)
Have an ostomy or ileoanal pouch
Diagnosed with short gut or short bowel syndrome
Recent bowel resection in the past 3 months
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NCT03105128
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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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Hershey, PA

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis

this study is looking for patients with compensated cirrhosis as the result of non-alcoholic steatohepatitis (NASH). ]). NASH is the result of too much fat within the liver, resulting in injury and death to individual liver cells; the presence of injury like this is followed by progressive formation (laying down) of liver fibrosis (scar tissue); the result of this is increased liver stiffness. As more and more fibrosis is formed and laid down in the liver, the outcome is cirrhosis. Compensated cirrhosis means the liver has become very scarred but can still perform many important bodily functions. This research is being done to find out how safe and effective the investigational drug (also called a study drug) obeticholic acid (also known as OCA) may be in improving compensated cirrhosis caused by NASH (non-alcoholic steatohepatitis). Currently, there are no therapies approved for the treatment of NASH. OCA (the brand name is Ocaliva) has been approved in several regions in North Americacountries (including the United States,and Canada) and Europe) for the treatment of another form of chronic liver disease called Primary Biliary Cholangitis (PBC).
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
NASH with cirrhosis
willing to use contraception
Exclusion Criteria:
hepatic decompensation
history of liver transplant
significant cardiovascular disease
alcohol abuse
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NCT03439254
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Hershey, PA

A 5-year Longitudinal Observational Study of the Natural History and Management of Patients with Hepatocellular Carcinoma

TARGET-HCC is a 5-year, longitudinal, observational study of the natural history and management of patients with HCC.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 17175315226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
male or female >18
diagnosis of hepatocellular carcinoma
Exclusion Criteria:
unable to provide written informed consent
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NCT02954094
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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 717-531-0003
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
age 50 and older who are undergoing their first ever screening colonoscopy
adults age 70 and older with colonoscopy more than 9.5 years ago
willing to provide blood, urine and stool samples
able to tolerate removal of 5 tubes (3.5 tablespoons) of blood
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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Hershey, PA

A Phase II/III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of BI 655130 Induction Therapy in patients with moderate-to-severely active ulcerative colitis who have failed previous biologics therapy

This study is for patients with moderate to severe ulcerative colitis (UC) who haved failed treatment with biologic medications. This research is being done to test the safety and effectiveness of BI 655130 (study drug) in patients with UC. This research is also looking at how the study drug is used by the body, how fast or slow the study drug moves through or out of the body, and how the body reacts to the study drug.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Diagnosis of ulcerative colitis for at least 90 days
Failure or intolerance of biologic medications
Extensive colitis or pancolitis more than 10 years duration
Exclusion Criteria:
Abdominal abscess or fulminant colitis at screening
Toxic megacolon at screening
Have any type of ostomy
Anticipating surgical intervention for UC
Fecal transplant within past 6 months
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NCT03482635
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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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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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Hershey, PA

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Induction Study to Assess the efficacy and Safety of Risankizumab in Subjects with Moderately to Severely Active Crohn's Disease Who failed Prior Biologic Treatment

This study is for patients who have moderately to severely active Crohn's disease who have failed prior biologic treatment and are experiencing symptoms such as diarrhea with or without blood, abdominal pain and/or a sudden and constant feeling that you have to move your bowels. This research is being done to evaluate the safety of different doses of risankizumab and determine how well it works in subjects with moderate to severe Crohn’s disease. Risankizumab is an investigational drug, which means that it has not been approved by the Food and Drug Administration (FDA) in the United States.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 7175315226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
Hide eligibility criteria
Inclusion Criteria:
Confirmed diagnosis for Crohn's disease
Intolerance or inadequate response to biologic agent
Exclusion Criteria:
Diagnosis of ulcerative colitis or indeterminate colitis
Currently taking corticosteroids
Have an ostomy or ileoanal pouch
Known complication of Crohn's such as abscess, strictures, toxic megacolon
Diagnosed with short gut or short bowel syndrome
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NCT03104413
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Hershey, PA

NASH Fitness Intervention for Thrombosis (NASHFit) Trial

Nonalcoholic fatty liver disease (NAFLD) is the leading cause of chronic liver disease in the United States. The most advanced forms of NAFLD are associated with increased liver-related mortality and lower overall survival. The current standard of care for NAFLD is lifestyle changes through diet and exercise. The human genome and regulation of gene expression is influenced by physical activity. NAFLD is a prothrombotic state with derangements in all three phases of hemostasis leading to clinically important clotting events. Exercise can improve coagulation in healthy persons. In this proposal, we seek to begin a line of work to answer the question “Can lifestyle changes effectively mitigate the increased risk of clotting in patients with NAFLD?” focusing initially on the at-risk population genetically susceptible to advanced disease.
Jonathan Stine at jstine@pennstatehealth.psu.edu or 717-531-1017
All
18 year(s) or older
This study is NOT accepting healthy volunteers
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Inclusion Criteria:
Nonalcoholic fatty liver disease (NAFLD)
Evidence of hepatic steatosis by imaging
Exclusion Criteria:
>90 minutes/week of at least moderate intensity exercise over the previous three months
Pregnancy
Active cardiac symptoms
Uncontrolled diabetes (changes in medication dosing over the previous three months or hemoglobin A1c >9%)
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NCT03518294
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Hershey, PA