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Suggestions within category "Digestive Systems & Liver Disease"


15 Study Matches

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 717-531-5226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT02548351
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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
Digestive Systems & Liver Disease
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Hershey, PA

;Induction Study #1 - A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn’s Disease

This study is for patients who have been diagnosed with moderate to severe Crohn's disease (CD) or have signs and symptoms of moderate to severe Crohn's disease. This is a drug study that will examine if Ozanomid is safe and effective in treating patients with CD.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03440372
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Inclusion Criteria:
Symptoms consistent with Crohn's disease for at least 3 months
Inadequate response or loss of response to Crohn's treatment
At high risk for cancer of the colon
Exclusion Criteria:
Has other diagnosis of colon disease(s)
Have an ostomy
History of extensive small bowel resection
Suspected infection of abdomen that has not been treated
Significant cardiovascular disease
Digestive Systems & Liver Disease
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State College, PA

INDUCTION STUDY #1 - A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ORAL OZANIMOD AS INDUCTION THERAPY FOR MODERATELY TO SEVERELY ACTIVE CROHN’S DISEASE

This study is for patients who have been diagnosed with or have signs and symptoms of moderately to severely active Crohn's disease (CD) which is a chronic inflammatory disorder of the bowels. People with CD often suffer from diarrhea, abdominal pain, rectal bleeding, weight loss, and fever. This study is being done to see whether an experimental medication that is not approved by the Food and Drug Administration, is safe and effective for the possible treatment of CD. To do this, a comparison will be made between people who receive active drug and people who receive placebo (a ‘dummy treatment’ that looks like the active drug but contains no active ingredient). The purpose of this study is to confirm preliminary results from a phase II study that suggests that the active drug may be safe and effective in treating patients with CD.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03440372
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Inclusion Criteria:
Ages 18-75, inclusive
Diagnosis of Crohn's Disease for at least 3 months
Failed prior treatment
Exclusion Criteria:
Will need surgery in 3 months
Stricture or obstruction symptoms
Prior cancers
Drug or alcohol abuse within 1 year
Diagnosis of colitis
Digestive Systems & Liver Disease
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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.
Amanda Taylor Gehman at ataylor6@pennstatehealth.psu.edu or 717-531-1283
All
18 year(s) or older
This study is also accepting healthy volunteers
NCT01511653
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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
Prevention, Digestive Systems & Liver Disease, Cancer
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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
NCT03439254
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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
Digestive Systems & Liver Disease
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Hershey, PA

A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis

This study is for patients who have active eosinophilic esophagitis (EoE). This research is being done to evaluate the safety and effectiveness of an experimental medication on relieving EoE symptoms and reducing esophageal inflammation in adults. The information derived from this study will also help to better understand how the medication works in the body and side effects that may be experienced by people taking the medication.
Larisa Zifchak at lzifchak@pennstatehealth.psu.edu or 717-531-4506
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03633617
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Inclusion Criteria:
18 and older
Diagnosis of Eosinophilic Esophagitis
Exclusion Criteria:
History of achalasia, ulcerative colitis, Crohn's disease or celiac disease
Prior esophageal surgery
History of bleeding disorders or esophageal varices
Anticipated major surgery
Active (acute or chronic) infections
Digestive Systems & Liver Disease
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Hershey, PA

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Non-Cirrhotic Subjects with Primary Sclerosing Cholangitis

This study is for patients with Primary Sclerosing Cholangitis which is a chronic disease which causes scarring of the bile ducts. This can lead to damage of the liver over time. The purpose of this study is to see if an experimental medication slows the scarring process.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03890120
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Inclusion Criteria:
18-70 years old
Diagnosis of Primary Sclerosing Cholangitisi
Exclusion Criteria:
Liver cirrhosis
Received a liver transplant
Liver cancer
HIV or Hepatitis B or C diagnosis
Alcohol use exceeding limits
Digestive Systems & Liver Disease
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Hershey, PA

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate to Severe Ulcerative Colitis

This study is for patients with moderate to severely active ulcerative colitis to measure how effective and safe an experimental medication is in treating this condition.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03934216
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Inclusion Criteria:
moderate to severe ulcerative colitis
failed prior treatment
Exclusion Criteria:
women breast feeding or pregnant
no cancer in past 5 years
no Crohns disease
Digestive Systems & Liver Disease
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Hershey, PA

CHARM II: Chemotherapy for Ablation and Resolution of Mucinous Pancreatic Cysts: A Prospective, Randomized, Double-blind, Multi-center Clinical Trial

This study seeks to verify the findings of the CHARM I pilot study by conducting a multi-center clinical trial. We hypothesize that: • Pancreatic cyst infusion with a specifically designed drug therapy cocktail following normal saline lavage will result in cyst destruction rates that do not significantly differ from those achieved by alcohol-based cyst treatment (ethanol lavage followed by infusion of the same chemotherapeutic cocktail). • The removal of alcohol from the procedure will decrease both serious and minor adverse event rates associated with pancreatic cyst treatment. • There may be molecular markers contained within the fluid of these cystic tumors which identify cysts that are favorable to or resistant to EUS-guided fine needle infusion using this drug combination. As such, we will test all treated cysts for 10 of the best known molecular markers for evaluation in post study analysis. We expect that administering a specifically designed chemotherapeutic cocktail without prior alcohol lavage will result in an equivalent rate of cyst resolution with fewer complications when compared to alcohol. The results of this study will provide important information about the most efficient and safest method for treating premalignant pancreatic cysts, an important step for treating these lesions with a minimally invasive technique and preventing their progression to cancer. Standard alternative treatment options for this patient group (if not taking part in this study) would be ongoing periodic radiographic monitoring with MR or CT imaging waiting for signs of cancer to develop or to consider surgical removal of the affected tissue.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03085004
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Inclusion Criteria:
Adult subjects over the age of 18.
Patients with a previously-detected pancreatic cyst(s) 2-5 cm in diameter which are consistent with a mucinous type cyst as per ASGE guidelines including indeterminate type cysts.
Ability to give written informed consent.
Capable of safely undergoing endoscopy with deep sedation or general anesthesia.
Exclusion Criteria:
Lesions which are consistent with a benign cyst by clinical, cytological, chemical, and radiographic evaluation as per ASGE guidelines37 (i.e., consistent with a pseudocyst or serous cystadenoma).
Known or suspected pancreatic cancer or pathologic lymphadenopathy.
Cysts with the following high risk features: main pancreatic duct dilation of > 5mm,epithelial type mural nodules , pathologically thick wall/septation (> 2mm)..
Septated cysts with > 4 compartments.
Confirmed pancreatitis within the last 3 months.
Digestive Systems & Liver Disease, Cancer
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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.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03518294
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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%)
Blood Disorders, Digestive Systems & Liver Disease, Sports Medicine
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Hershey, 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
NCT01848561
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Inclusion Criteria:
Ulcerative Colitis
On Humira/Imuran or 6-MP
IBD
Exclusion Criteria:
Indeterminate Colitis
Crohn's Disease
Digestive Systems & Liver Disease
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State College, PA

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Induction Therapy in Subjects With Moderate to Severe Crohn’s Disease (CARMEN CD 306)

This study is for patients with moderate to severe Crohn's disease. This research is being done to determine whether an investigational drug is safe and effective when compared to placebo (a treatment that does not contain active drug) in the treatment of patients with moderate to severe Crohn's disease.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03566823
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Inclusion Criteria:
Diagnosis of Crohn's disease for 3 months
Ages 18-80
Exclusion Criteria:
History of other forms of colitis
History of colon polyps (if removed may be eligible) or cancer
Past medical history of toxic megacolon
Current symptomatic diverticulitis or diverticulosis
Past medical history of multiple small bowel resections
Digestive Systems & Liver Disease
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State College, PA

AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis

This study is for patients diagnosed with non-alcoholic steatohepatitis or NASH, which is a type of liver disease known as fatty liver. This research is being done to find out how safe and effective an experimental medication is when compared to a placebo for the treatment of liver fibrosis in patients with NASH. A placebo looks like the study drug but does not contain the study drug’s active ingredient.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03028740
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Inclusion Criteria:
18-75 years of age
Diagnosed with Non-Alcoholic Steatohepatitis (NASH) or fatty liver
No new treatment for NASH in the past 6 months
Exclusion Criteria:
Hepatitis B or C
HIV
Prior or planned liver transplant
Other known causes of chronic liver disease such as cirrhosis
Weight reduction through bariatric surgery in the past 5 years or planned
Digestive Systems & Liver Disease
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Hershey, PA

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects with Moderate-to-Severe Crohn's Disease

This study is for patients with moderate to severely active Crohn's disease to measure how effective and safe an experimental medication is in treating this condition.
Laurie Peiffer at lpeiffer@pennstatehealth.psu.edu or 717-531-5226
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03599622
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Inclusion Criteria:
moderate to severe crohn's disease, 3 months
failed prior treatment
Exclusion Criteria:
severe or fulminant colitis requiring surgery
presence of stoma, gastric pouch
prior bowel resection, 6 months
bleeding disorders
cancer < 5 years
Digestive Systems & Liver Disease
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Hershey, PA

A phase III, randomized, double blind, parallel group, placebo controlled, international, multicentre study to assess efficacy and safety of Cx601, adult allogeneic expanded adipose-derived stem cells (eASC), for the treatment of complex perianal fistula(s) in patients with Crohn’s disease over a period of 24 weeks and a follow-up period up to 52 weeks. ADMIRE-CD II study.

This study is for patients with Crohn's disease which involves an investigational new drug to treat perianal fistulas in patients with Crohn’s disease (CD). The purpose of this study is to find out: 1) How well the study drug works at a single dose compared to a placebo; 2) how safe and tolerable the study drug is in patients with fistulizing CD.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03279081
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Inclusion Criteria:
Diagnosis of Crohn's Disease for at least 6 months
Presence of complex perianal fistulas
Clinically controlled, non active or mildly active CD during the last 6 months
Patients whose perianal fistulas were previously treated and have shown an inadequate response
Exclusion Criteria:
Any major surgery of the GI tract within past 6 months
Patients without prior specific treatment for perianal complex fistulas
Patients with diverting stomas
Patients with active, uncontrolled infection requiring IV antibiotics
Patients with allergies or hypersensitivity to penicillin or aminoglycosides, local anesthetics or MRI contrast
Infectious Diseases & Immune System, Digestive Systems & Liver Disease
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Hershey, PA