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Suggestions within category "Digestive Systems & Liver Disease"


20 Study Matches

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.
Stella Z. Chroneos at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
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 1, Double Blind, Randomized, Placebo-Controlled, Multi-Center, Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD2693 in Patients with Non-Alcoholic Steatohepatitis (NASH) with Fibrosis Stage 0-3 and Carriers of the PNPLA3 148M Risk Allele

The purpose of this voluntary research study is to test the safety and ability to tolerate of the an injection treatment of the study drug AZD2693 in patients with Non-alcoholic Steatohepatitis (NASH).
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04483947
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Inclusion Criteria:
BMI within the range 25 to 45 kg/m2
NASH diagnosis
Exclusion Criteria:
history of liver transplant
pre-existing renal disease
Digestive Systems & Liver Disease
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Hershey, PA

A Seamless, Adaptive, Phase2b/3, Double-blind, Randomized, Placebo-controlled, Multicenter, International Study Evaluating the Efficacy and Safety of Belapectin (GR-MD-02) for the Prevention of Esophageal Varices in NASH Cirhosis

This trial will evaluate the study drug Belapectin in patients with NASH (Non-Alcoholic Steatohepatitis) Cirrhosis. The purpose of this voluntary research study is to find out about the safety and efficacy of the study drug and for the prevention of esophageal varices in NASH Cirrhosis. .
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04365868
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Inclusion Criteria:
Adults age >18-75 years old
early stage cirrhosis
diagnosis of NASH
Exclusion Criteria:
end stage cirrhosis
substance abuse
other liver disease
history of organ transplant
Digestive Systems & Liver Disease
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Hershey, PA

A Multicenter, Randomized, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Oral Etrasimod as Induction and Maintenance Therapy for Moderately to Severely Active Crohn’s Disease

This is a phase 2/3, multi-center, randomized, double-blind, study for patients with moderate to severe Crohn's disease. Subjects with refractory CD or who are intolerant to at least one current therapy will be considered. The study consists of four substudies. They are designed to investigate efficacy, safety, tolerability of etrasimod as therapy for CD.
Zvjezdana (stella) Sever Chroneos at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04173273
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Inclusion Criteria:
Age 18-80 years
Crohn's disease >3 months
Inadequate response, LOR or intolerance to more than one therapies
Females must not be/intent to be pregnant
Exclusion Criteria:
History of inadequate response to more than two biologics
Use of certain therapies less than 2 weeks prior to randomization
Hypersensitivity to Entrasimod
Have UC diagnosis
Has infection
Digestive Systems & Liver Disease
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Hershey, PA

A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide for Relief of Persistent Symptoms in Patients with Celiac Disease on a Gluten Free Diet

This study is for patients with Celiac disease. We are studying whether an investigational drug will reduce symptoms associated with Celiac disease when taken while on a gluten free diet.
Zvjezdana (Stella) Sever at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03569007
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Inclusion Criteria:
BMI between 16 and 45
Celiac diagnosis for at least 6 months
Follows a gluten free diet
Exclusion Criteria:
Open abdominal surgery in the last 6 months
Chronic GI disease other than celiac
Received antibiotics in past 4 weeks
Diagnosis of cancer in past 5 years
Uncontrolled Type 2 diabetes
Digestive Systems & Liver Disease
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Hershey, PA

Mobile Health Delivered Lifestyle Intervention Program in Patients with Nonalcoholic Steatohepatitis: A Proof of Concept Study

Subjects will be given access to the Noom Healthy Weight (HW) application for 16-weeks.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04872777
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Inclusion Criteria:
Adults age >18 years
NASH diagnosis
possession of smart phone
Exclusion Criteria:
Active or recent participation in lifestyle intervention program
Active weight-loss supplement use
Cirrhosis
Inability to provide informed consent
Other chronic liver disease
Digestive Systems & Liver Disease
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Visceral Pain Sensation and Nav1.8

We wish to investigate the role of a specific gene in visceral pain sensation and perception. This gene, Nav1.8 has a known change present in 10% of the population which may affect the way we feel inflammatory pain in the gut. This is an important symptom in inflammatory bowel disease (IBD). Some patients feel high levels of pain we would like to control, other patients feel little to no pain in the presence of very active disease, which can lead to dangerously under-treated disease. In this study, we will use healthy volunteers of a known genotype for Nav1.8, and test their sensitivity using rectal balloon dilation. Research subjects will be asked to fast, skipping solid foods and opaque liquids for 6 hours before the testing. Usually this means skipping 1 meal. At the beginning of the study visit. they will use an over the counter enema to clear their rectum of any stool. Then. a trained physician on the research team will insert a thin, lubricated tube into the rectum, which will be inflated to specific pressures. Most of these tests will be designed to measure any change in sensation, then the need to use the toilet, followed by urgent need or discomfort, and lastly the lower threshold of pain. Patients will be able to stop testing at any time, should they become too uncomfortable. The testing takes between 1 and 1 and a half hours, and volunteers are compensated $200 for their time.
All
18 year(s) or older
This study is also accepting healthy volunteers
N/A
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Inclusion Criteria:
Healthy lower digestive tract
Had a colonoscopy in HMC health record within the past 2 years for any reason
Exclusion Criteria:
Any lower GI disease
Any significant abdominal pain and/or changes in bowel habits in the past year
Any peripheral neuropathy or neuromodulating/opioid medications
Any autoimmune disease
Infectious Diseases & Immune System, Digestive Systems & Liver Disease, Pain Management
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Hershey, PA

CC-93538-EE-001 – A PHASE 3, MULTI-CENTER, MULTI-NATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS

The scope of the study is to use a novel biologic drug, CC-93538, against symptoms of esophageal dysfunction and inflammation in subjects with Eosinophilic esophagitis (EoE). The CC-93538 will target the IL-13 receptor, a key driver of disease pathology in EoE. The phase 3 program will evaluate the safety and efficacy of CC-93538 in placebo-controlled Induction, Maintenance, and Open-Label Extension study.
Zvjezdana "Stella" Chroneos at zchroneos1@pennstatehealth.psu.edu or 717-531-0003, ext=322136
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04753697
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Inclusion Criteria:
Adults with body weight more than 40 kg
Histologic evidence of EoE
Symptoms of dysphagia
Previous therapy with PPI medications, intolerant or inadequate corticosteroid response, or steroid responders/naive
Must agree to maintain stable diet
Exclusion Criteria:
Active, ongoing infections
Liver function impairment, structural abnormality of esophagus
Receiving concurrent treatment with another IP, or the same drug previously
Currently is succesfully treated for EoE with dietary modifications
Currently receiving corticosteroids
Digestive Systems & Liver Disease
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Hershey, PA

The effect of semaglutide in subjects with non-cirrhotic non-alcoholic steatohepatitis

NASH is associated with increased risk of mortality. Currently, there are few treatment options. Therefore, there is a need for an effective and safe medication treatment options. Semaglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), can address certain aspects of NASH and is therefore considered a strong candidate for the treatment of NASH.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04822181
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Inclusion Criteria:
Biopsy consistent with NASH and presence of fibrosis stage 2 or 3
able to provide consent
18 years or older
Exclusion Criteria:
previous participation in this trial
known/suspected allergic reaction to study drug
pregnancy
cirrhosis
hepatocellular carcinoma
Digestive Systems & Liver Disease
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Hershey, PA

RESPONSE: A Placebo-controlled, Randomized, Phase 3 Study to Evaluate the Efficacy and Safety of Seladelpar in Patients With Primary Biliary Cholangitis (PBC) and an Inadequate Response to or an Intolerance to Ursodeoxycholic Acid (UDCA)

The purpose of this voluntary research study is to determine if an investigational drug, seladelpar, is safe and effective in treating patients with Primary Biliary Cholangitis compared to placebo (which looks like the study drug but is not active medication). This is a Phase 3, international, multicenter evaluation of seladelpar in a randomized, double-blind, placebo-controlled, parallel-group study when administered for up to 12 months as a daily oral capsule in patients with 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
NCT04620733
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Inclusion Criteria:
PBC diagnosis with liver biopsy
UDCA stable dose 3 months
Alkaline phosphatase > 1.67
Alanine transaminase < 3Xupper level normal
platelet count > 100
Exclusion Criteria:
liver transplant
hepatitis b, hepatitis c, HIV infection
cirrhosis
cancer, 2 years
Digestive Systems & Liver Disease
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Hershey, PA

A Phase 3 Study of the Efficacy, Safety and Pharmacokinetics of Ustekinumab as Openlabel Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous (SC) Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis (UC)

The primary objective and primary endpoint in this study is to assess clinical remission. participants who were in clinical response in induction.  To evaluate the safety profile of ustekinumab (study drug). Participants who meet inclusion criteria will receive ustekinumab through and IntraVenous infusion during the induction period. And then will be randomized either every 8weeks or 12weeks to receive ustekinumab through a SubCutaneous injection.
Erica Miller at emiller25@pennstatehealth.psu.edu or 717-531-5656
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT04630028
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Inclusion Criteria:
Ages 2 to 18years at the time of the first administration of study drug
Must have Ulcerative Colitis diagnosed prior to screening
Must have moderately to severely active Ulcerative Colitis
Exclusion Criteria:
Have severe extensive colitis
Have Ulcerative Colitis limited to the rectum only
Presence of a stoma
Presence or history of a fistula
Digestive Systems & Liver Disease
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Hershey, PA

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

The objective of Sub-Study 1 (Phase 2b induction) is to characterize the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC) and to identify the appropriate induction dose of risankizumab for further evaluation in Sub-Study 2 (Phase 3 induction). The objective of Sub-Study 2 (Phase 3 induction) is to evaluate the efficacy and safety of risankizumab compared to placebo in inducing clinical remission in subjects with moderately to severely active UC.
Z. Stella Sever Chroneos at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03398148
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Inclusion Criteria:
Confirmed diagnosis of UC for at least 3 months prior to Baseline
Males or females ≥ 18 and ≤ 80 years of age
Demonstrated intolerance or inadequate response to one or more categories of drugs
Females of childbearing potential must have a
Subject must be able and willing to give written informed consent and to comply
Exclusion Criteria:
Subject with a current diagnosis of Crohn's disease (CD) or IBD-unclassified
Subject on oral UC-related antibiotics, oral aminosalicylates, oral corticosteroids or on immunomodulators
Subject who received any live bacterial or viral vaccination within 35 days
Subject who received fecal microbial transplantation within 35 days
Subject who received any approved biologic agent or ustekinumab [Stelara
Digestive Systems & Liver Disease
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Hershey, PA

A Multicenter, Randomized, Double-Blind, Placebo-Controlled 52-Week Maintenance and an Open-Label Extension Study of the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis

There are three sub-studies in this protocol. The first scope of the study is to continue the treatment for Ulcerative colitis with risankizumab versus placebo as maintenance therapy in subjects with moderate to severe UC who responded to IV risankizumab induction treatment (study M16-067). The second scope evaluates the safety and efficacy of two different dosing regimens for risankizumab as maintenance therapy in subjects who responded to the induction treatment in study M16-067. The third scope is to evaluate the long-term safety of risankizumab in subjects who completed sub-study 1 or 2 or subjects who responded to induction treatment in study M16-067 with no final endoscopy.
Z Stella Chroneos at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03398148
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Inclusion Criteria:
Entry and completion of Study M16-067
Achieved clinical response after M16-067 treatment
If female must continue practicing birth control
Subject must be able and willing to give written informed consent
Exclusion Criteria:
Subject has high grade colonic dysplasia or colon cancer
Subject who has a known hypersensitivity to risankizumab
Confirmed positive urine pregnancy test
Subject with any active or chronic recurring infections
Have a known history of lymphoproliferative disease
Digestive Systems & Liver Disease
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Hershey, PA

Efficacy and safety investigation of NNC0194-0499 co-administered with semaglutide in subjects with non-alcoholic steatohepatitis: a dose-ranging, placebo-controlled trial

Currently, no drugs are globally approved for the treatment of non-alcoholic steatohepatitis (NASH). First-line of treatment is lifestyle intervention to achieve weight loss. Combination treatment with multiple drugs may be more effective. This trial will assess the safety and efficacy of three doses of NNC0194-0499 (the study drug) in combination with semaglutide versus placebo in the treatment of NASH.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05016882
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Inclusion Criteria:
Aged ≥ 18 years at the time of signing informed consent
Evidence of NASH based on a liver biopsy
Stage 2, 3 or 4 of fibrosis
non-alcoholic fatty liver disease (NAFLD) activity score (NAS) ≥ 4
Exclusion Criteria:
causes of chronic liver disease other than NAFLD
cirrhosis
Treatment with vitamin E
alcohol dependence
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 acute pancreatitis within the last 3 months.
Digestive Systems & Liver Disease, Cancer
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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 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

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

A Phase 3, Multicenter, Randomized, Efficacy Accessor-Blinded Study of Risankizumab Compared to Ustekinumab for the Treatment of Adult Subjects With Moderate to Severe Crohn's Disease Who Failed Anti-TNF therapy

This study will compare the efficacy and safety of risankizumab versus ustekinumab for the treatment of adult subjects with moderate to severe Crohn's disease who have failed anti-TNF therapy.
Zvjezdana Stella Sever Chroneos at zchroneos1@pennstatehealth.psu.edu or 717-531-8259
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04524611
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Inclusion Criteria:
Confirmed diagnosis of CD for at least 3 months
Demonstrated intolerance or inadequate response to one or more anti TNF therapies
Laboratory values meeting protocol criteria
CDAI score of 220-450 at Baseline
Exclusion Criteria:
No history of UC
No known complications of CD
No systematic bowel strictures
No history of malignancy
No history of allergic reactions to the products in the same class
Digestive Systems & Liver Disease
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Hershey, PA

NASH AMPK Exercise Dosing (AMPED) Trial

The purpose of this trial is to test different levels of exercise needed to reduce liver fat in patients with NASH.
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04987879
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Inclusion Criteria:
Adults age >18 years
NASH diagnosis
BMI 30-45 kg/m2
sedentary lifestyle
Exclusion Criteria:
pregnancy
Active cardiac symptoms
Cancer that is active
Inability to provide informed consent
Other liver disease
Digestive Systems & Liver Disease
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Hershey, PA

A Phase 3 Study of the Efficacy, Safety, and Pharmacokinetics of Ustekinumab as Open-label Intravenous Induction Treatment Followed by Randomized Double-blind Subcutaneous(SC) Ustekinumab Maintenance in Pediatric Participants with Moderately to Severely Active Crohn’s Disease

The primary objective and primary endpoint in this study is to assess clinical remission.  To evaluate the efficacy of ustekinumab dosing in maintaining clinical remission among participants who were in clinical response in induction.  To evaluate the safety profile of ustekinumab.  To evaluate ustekinumab exposure (pharmacokinetics [PK]).  To evaluate the efficacy of IV ustekinumab during the induction period.  To evaluate the efficacy of SC ustekinumab during the maintenance period among participants who were in clinical response in induction.
Erica Miller at emiller25@pennstatehealth.psu.edu or 717-531-5656
All
Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT04673357
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Inclusion Criteria:
Ages 2 to 18years at the time of the first administration of study drug
Must have been diagnosed with moderately to severely active Crohn's Disease prior to screening
Exclusion Criteria:
Has had any kind of bowel resection within 6months
Currently has or is suspected to have an abscess
Digestive Systems & Liver Disease
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Hershey, PA