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 as well as IBD patients, 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. Healthy control subjects that have never had a colonoscopy before and all IBD patients will undergo a very brief proctoscopy to either verify rectal health or check for any IBD disease activity. Healthy controls that have had a prior colonoscopy within the last 5 years will skip that prior step. 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. Test subjects 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.

To simulate abdominal pain, we use a thin tube placed in the rectum that inflates a small balloon to very precise and safe pressures. Our bodies interpret these pressures (in ascending order) as the need to go to the bathroom; first just a little, then with increasing urgency and eventually discomfort and pain. During these experiments, we only measure the lower threshold of pain, and stop immediately when you tell us to stop. We have significant experience using this approach and we have found it consistently informative while causing the least amount of discomfort possible. The whole thing takes about an hour and we’re paying volunteers $200 for participating. We'll ask that you skip a meal before the study visit, and perform an over-the-counter enema at the start of the visit.

$200

This is a Phase 2, multicenter, double-blind, randomized, 52-week study to assess the efficacy and safety of K-001 medication compared with placebo in subjects with noncirrhotic NASH with liver fibrosis. This study will look at a study drug, called K-001, for participants with a liver condition called noncirrhotic nonalcoholic steatohepatitis (NASH). This condition is defined by a build-up of fat in the liver, which causes liver damage and inflammation. Due to this damage, the liver does not work as well. If left untreated, NASH can lead to liver fibrosis (scarring of the liver), liver cancer, or liver failure. K-001 is a once daily pill that contains combination of two medicines: K-877-ER and CSG452. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with NASH with liver fibrosis. To answer these questions, the study drug will be compared with a placebo.

There will be 10 in person visits over 52-week study period. Various procedures will be completed such as a fibroscan, ECG, liver MRI, liver biopsy, blood draws. You will be randomly assigned by chance (like the flip of a coin) to receive the study drugs or placebo (inactive substance). You will be taking a pill once daily.

$1310

This study will be a pilot study to evaluate the workability, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program previously confirmed in patients with cirrhosis,(1) in patients with Nonalcoholic Steatohepatitis (NASH)

El-Fit NASH (Nonalcoholic Steatohepatitis) is a 9-week intervention trial for patients with NASH. Our goal is to evaluate the workability, safety and acceptability of Exercise and Liver FITness (EL-FIT), a mHealth exercise training program. The El-FIT application allows for participants to access to a library of guided workouts. All patients will be asked to complete a screening visit that includes a physical exam, height, and weight measurements & surveys. Participants will be asked to download the EL-Fit NASH application and use it for 8 weeks. In addition to using the application, participants will be asked to complete 3 check-in phone calls through-out the 8 weeks.

Our team has created and validated an iVR dietician program known as the Immersive Virtual Alimentation and Nutrition (IVAN). The goal of this project is to translate the IVAN program to practice and community research. We plan to accomplish this by performing a randomized clinical trial evaluating the effect of the IVAN program in combination with synchronous audio/video dietary counseling on self-reported dietary intake and weight compared to in-person counseling. Concurrently, we will provide a survey assessing implementation outcomes to both groups as well as our team's dietician at each study visit, and crossover the intervention at study completion so all participants assess the IVAN program. Additionally, we will have ourclinic health care providers experience the IVAN program and assess implementation outcomes.

Participants will be randomly assigned to receive one of the two study treatments, either the standard of care in-person dietary education with a dietician or the experimental treatment using iVR for dietary education in conjunction with a dietician. Participants will complete a dietary intake assessment tool and measure their weight using a scale provided by our team starting the week before the first dietary education visit. Participants will continue to weigh themselves at least once weekly and additionally complete the dietary intake assessment on 5 weeks over the course of the study. Each dietary intake assessment includes 2 weekdays and 1 weekend. Participants will attend 3 sessions in Penn State’s Clinical Research Center over 12 weeks for either 30 minutes of dietary education from a either dietician or the iVR program. In either case, there will have an additional 30 minutes of time with the dietician for questions and discussion. Participants will complete a survey associated with the education session at each visit. Participants are free to skip any question he/she would prefer to not answer. We anticipate the survey will last no more than 30 minutes.At the final study session, certain participants will also undergo a liver ultrasound (Fibroscan) based on the date of their most recent Fibroscan. This is expected to last no more than 30 minutes.

100

This is a phase 2, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy and safety profile of barzolvolimab (CDX-0159) in patients with active EoE. The study will enroll approximately 60 patients.This study consists of four distinct phases lasting approximately a year. Each patient will receive 1 dose (2 injections) every 4 weeks. The participants will be required to sign the informed consent before any procedures are performed. If eligible for screening, they will need to have standard lab tests (blood and urine), EKG, pregnancy test if applicable, and tests for COVID-19. They will also be required to have EGD with biopsies done during the screening period and at weeks 12 and 28. If eligible to continue, the participants will be randomized on day 1, when they will receive their first treatment. They will be required to come back to the clinic in two weeks and four weeks after that. They will have to complete the e-diary questionnaires at home.

There will be ten in person visits, including screening, placebo-controlled treatment and active (open label) treatment. In addition, there are four follow up visits every 4 weeks. The participants must sign the informed consent. There are going to have vital signs checked at every visit. Some visits have a physical exam. There are blood tests, urine tests, ECG, and COVID -19 tests done. The participants will have EGD procedure with biopsies at screening, and at 12 and 28 weeks of treatment. There will be four study treatments administered in the clinic. The concomitant medications, and adverse events will be monitored and documented. Serum and urine pregnancy tests will be performed if applicable. Participants will be asked to complete electronic diary daily.

$75 per visit; you may receive travel reimbursement $50, and $50 meal compensation for visit 1, 2, 5, 7, and 9

The purpose of this trial is to test different levels of exercise needed to reduce liver fat in patients with NASH.

If you take part in this research, your major responsibilities will include: •Completing exercise sessions (if randomized to exercise group). A typical exercise session will include a 5 minutes warm-up with stretching, 15-45 minutes of brisk walking, jogging or recumbent bike and a 5-minute cool-down.

250.00

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.

The study consists of a screening period, a 14-week induction period, a 6-week extended induction period (if applicable), and a follow-up period. •The subject will have to go to the study center for the visits and follow the instructions the study doctor and the study team give them, and take the study medication, as directed.They are required to bring all unused study medication and packaging to each study visit. The subject should complete their eDiary every day and bring it with you to all visits. They also must remember to return your Holter monitor to the study clinic.Other tests that the subject is required to complete will include ECG, drug test, TB test at screening. Also urine and blood tests at all induction visits except day 1 extension, vital signs and physical at every visit, eye and pulmonary function tests will be done at screening.

$600

To evaluate the effect of Saroglitazar Magnesium compared with Placebo on liver scarring in patients with NASH.

There will be 11 in person visits, various procedures will be completed such as a fibroscan, liver biopsy, blood draws and DXA scan. You will be randomly assigned by chance (like the flip of a coin) to receive either Saroglitazar 4 mg or Saroglitazar 2 mg or placebo (inactive substance).

1,325

The purpose of this study is to evaluate the efficacy and safety of Saroglitazar Magnesium 4 mg Tablets once-daily in women with well characterized Polycystic ovary syndrome (PCOS) diagnosed with nonalcoholic fatty liver disease (NAFLD).

There will be 9 in person visits, various procedures will be completed such as a fibroscan, endometrial biopsy, blood draws and surveys. You will be randomly assigned by chance (like the flip of a coin) to receive either Saroglitazar 4 mg or placebo (inactive substance).

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.

Patients will have to sign the consent form to participate in the trial

Hepatic encephalopathy (HE) is a complication of liver cirrhosis (liver damage). It affects nearly half of people with cirrhosis. Because of the damage, the liver doesn’t work as well as it should, and some toxins stay in the body. HE occurs when too many toxins build up in the bloodstream and reach the brain. It can cause symptoms like confusion, personality changes, lack of energy, inappropriate behavior, sleep problems, loss of small hand movements and tremors in hands and arms.This study is looking to see if a study medicine, rifaximin, can safely delay or prevent HE. Adults who have been diagnosed with liver cirrhosis, but who don’t have yet HE may be eligible to join.•Participants will be in the study will up to 80 weeks. They will attend up to 21 study visits, including 14 visits to the clinic and 7 telephone check-ins.•If participants are eligible and choose to participate, they will be randomly (like a flip of a coin) assigned to one of two treatment groups: the study medicine or placebo (which contains no active ingredients). This means participants have a 50/50 chance of receiving the study medicine.•Both study groups will take their assigned study medicine study medicine as a pill twice a day.•The study is double-blind, which means neither the participant nor the study team will know which treatment they are receiving.

There will be 14 in person visits. Safety assessments will be done at each visit including blood tests and urine tests. Participants will need to take study drug as directed.

$1050.00

Voluntary research study is to test INBRX-101 as an experimental drug to treat patients with alpha-1 antitrypsin deficiency. The goal of this study is to evaluate the safety and study the therapeutic effects of INBRX-101 in AATD emphysema patients when compared with current approved AATD therapy with A1PI.

You will visit the study site up to a total of 37 times for blood sampling, computed tomography (CT) scan, lung function tests, electrocardiograms (ECGs), study drug administration and questionnaire completion.

Unknown at this time

This research study of fazirsiran (FAZ-i-sir-an; also called TAK-999 or the “study drug”) because you have alpha-1 antitrypsin deficiency-associated liver disease (AATD LD) with METAVIR stage F2 to F4 fibrosis (METAVIR is a system used to score the amount of inflammation and fibrosis seen in a liver biopsy).In AATD, abnormal (Z-AAT) proteins build up in liver cells, leading to varying amounts of liver problems. The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis

-The total amount of time you may be involved in the study is about 4 ½ years (230 weeks).-Screening Period of up to 70 days.-Treatment Period of 196 weeks or about 4 years. During the study, you will get the study drug or placebo at the study site.-Follow-up Period of 6 months. You will have visits 6, 12, and 24 weeks after your last injection of the study drug or placebo.-You will have lung function tests (PFT and DLCO) to check how your lungs are workingAt every visit during the treatment period you will have:-Your vital signs will be measured, this includes your heart rate, blood pressure, breathing rate, temperature, and amount of oxygen in your blood.-You will have a brief physical exam.-Your weight will be measured.-You will have an ECG.-Collect lab samplesDuring specific study visits during the treatment period the following tests will be performed:-An abdominal ultrasound-FibroScan-CT scansYou will complete questionnaires.

This study is a Phase 2b, 52-week randomised, double-blind, placebo-controlled, multi-centre, multinational trial comparing once monthly subcutaneous (SC) administration of AZD2693 in participants with non-cirrhotic NASH (F2-F3) who are homozygous for the PNPLA3 rs738409 148M risk allele. Over the course of the approximately year long protocol, study participants will be screened to determine whether they carry the allele, which is known to place those with the allele at an increased risk for fatty liver disease. Screening will further take place to evaluate a participant's inclusion in the study, to make sure they are an eligible candidate. This screening includes blood work, a physical, and some additional diagnostic tests. If a patient is determined eligible to be randomized, the participant will complete approximately bi-weekly visits for up to a year. These visits will include bloodwork and additional evaluations to make sure they are doing well, as they receive their injections. At the completion of the study, participants will complete a final work up to see if the treatment was safe and effective.

There will be a genetic screening for an allele of the PNPLA3 gene.There will be a further screening period to determine eligibility.There will then be up to 24 visits with up to 10 injections of the study drug or placebo. Visits will require various blood work, biopsies of the liver, ECG's, and questionnaires.

$1600

this is a phase II study to evaluate the safety and tolerability of 2 doses of elafibranor in participants with Primary Sclerosing Cholangitis (PSC), and its potential effect on the change in serum alkaline phosphatase (ALP) and other hepatic markers of PSC during 12 weeks of treatment in the double-blind period (DBP) compared to placebo. This will be followed by a 96-week open-label extension (OLE) period (no placebo) to assess long-term safety and maintenance of effects of elafibranor.After the first dose of the study intervention on Day 1, the participants will have study visits every 4 weeks through Week 12 of the DBP to assess efficacy and safety. In the OLE period, the study visits for each participant will occur after 4 weeks of entering the OLE, then every 12 weeks up to Week 52, followed by every 22 weeks up to Week 96 which will be the end of treatment (EOT). All participants will have a safety follow-up 4 weeks after the last dose of study intervention.

There will be 2 screening visits followed by 4 visits during the double blind/placebo part of the trial, followed by visits every 3 months for the open label part of the study. All visits will be in person. Blood will be drawn at every visit. Urine will be collected at most visits. ECG's (recording of your heart activity) will be done on a regular basis. Additional procedures include fibroscans (scan of your liver to determine liver stiffness) and ultrasound exams of your abdomen and bladder. Multiple questionnaires will be competed throughout the trial period.

At this time, there is no treatment available for celiac disease diagnosis. The study is designed to test safety, tolerability and pharmacokinetics of KAN-101 to treat celiac disease diagnosis. We will participate only in the Part C study portion. Part C is a Phase 2, double-blind, placebo-controlled, parallel design study to characterize the biomarker response (plasma IL-2) in peripheral blood following gluten challenge, safety, tolerability, and pharmacokinetics (how does drug move in the body) of KAN-101 in adult participants (18 to 70 years inclusive) with histology-confirmed celiac disease. Participants will be randomized 1:1:1:1, where one arm is placebo, and other arms are different drug doses. The study consists of a screening period to determine eligibility to participate, a run-in phase where participants are gluten-challenged for one day, a treatment phase where participants will receive a seven-days treatment, and observation period lasting 358 days where participants will have a post-dose gluten challenge on Day 15, and three other time-points. The study aims to enroll 120 subjects across all sites. Participants will be asked to come for the clinic visit, to have gluten challenged done in the clinic, and treatment infusions in the clinic. There are two follow-up visits planned. The participants will have required EGD w/biopsy, and will be offered optional EGD biopsy study, that collects specimens at two time points. All participants will have a blood work done to access eligibility for participation, and to test for drug PK and biomarkers in the response of the treatment. They will also have EKG and physical examinations, vital signs checked during the clinic visits. They will complete questions for patient reported symptoms. Eligible women participants will be tested for pregnancy, and contraception will be discussed for both male and female participants.

Participants will be asked to come to the clinic visits for the screening, gluten challenge, treatment visits and follow up. During the visits, participants will have blood tests done to determine eligibility for the study, or the test how the drug moves through the body and whether it works to dampen the celiac disease symptoms. The patients will have EGD with biopsies procedure done in the endoscopy suite, and they will be offered optional biopsies study. The gluten challenge will consist of drinking a glass of water containing 9g pre-prepared gluten challenge mix. The participants will be observed for four hours. The treatment is done via infusion in the clinic over 30-minutes,and observed for four hours after that. The participants will have to come in for three treatment visits within seven days (days 1, 4, and 7).

$1775

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..

If you consent to participate, you will be asked to have some screening tests and procedures, as described in the table below. This period of up to 3 visits within 2 months is called Screening Period. Based upon results of tests and procedures completed during these visits, your study doctorwill be able to decide if you meet the requirements to participate in this study. If you meet the study requirements to participate in this study, your study doctor will discuss with you when you should start the study treatment.

This is a multicenter evaluation of seladelpar, administered as a once-daily oral capsule, in a placebo-controlled study in subjects with Primary Biliary Cholangitis (PBC). This study (156 weeks) will enroll approximately 192 subjects. The population to be studied is patients with PBC and compensated cirrhosis restricted to Child-Pugh (CP)-A or CP-B.Primary ObjectivesEfficacy: To evaluate the effect of seladelpar compared to placebo.Safety: To evaluate the safety of seladelpar over 156 weeks of treatment compared to placebo.Study visits: up to 18 in person visits. Blood samples will be collected at each visit for safety measures as well and questions about your health and medicines you might be taking.

There will be 18 in person visits. safety assessments will be conducted at each visit. Participants will be required to take study drug as directed.

$1350

This is a multicenter, randomized, placebo-controlled Induction study to evaluate the efficacy and safety of oral ABX464 given daily in inducing clinical remission in subjects with moderately to severely active ulcerative colitis (UC) who have inadequate response, no response, a loss of response, or an intolerance to either conventional or advanced therapies.The screening period is 28 days long, and a 28-day follow-up follows 8 weeks of induction treatment. Approximately 612 subjects (only adults at our site) will be randomized in this study. On Day 1, subjects will be randomized to one of the three arms. On Day 56, subjects can either continue participation in the maintenance study (ABX464-107) or end the study by entering four-week safety follow-up. Colonoscopy procedures will include biopsies of the most severely affected areas. The subjects will complete daily electronic Diaries. Blood samples will be collected at some visits. A cardiac safety sub-study is optional for eligible subjects.

Participants will be asked to sign the informed consent. There are at least five in-person visits, approximately every four weeks. There are two colonoscopy procedures with biopsies: first during the screening period and second evaluation at week 56 at the end of the study. Physical examination and vital signs will be taken at every visit. Stool sample for pathogens will be collected at screening. Blood tests will be taken to test for infectious diseases and other tests. There is an optional cardiac safety study. Pregnancy testing is required for eligible female subjects at every visit. Subjects will complete e-Diary questionnaires. There will be two eye exam visits. Participation in the study is voluntary.

Subjects will receive a flat amount per completed visit, up to maximum of $425.

The goal of treatment with fazirsiran is to prevent and improve the build up of these abnormal proteins that cause liver injury and fibrosis by shutting down the production of Z-AAT. Decreasing Z-AAT build up in liver cells is important, as this protein has been clearly identified as the cause of liver injury in AATD.In this study, fazirsiran is being compared with a placebo for patients with AATD LD. A placebo is a liquid like fazirsiran but does not contain any active ingredients.

You will visit the study site approximately 12 times for blood sampling, computed tomography (CT) lung densitometry, lung function tests, FibroScans, ultrasounds, liver biopsy, esophagogastroduodenoscopy (EGD) study drug administration, and questionnaire completion.

The purpose of this prospective, multi-site study is to conduct a clinical evaluation of the investigational CN-6000 device using venous plasma specimens from adult participants in different care settings with various disease processes. This is a fully automated blood coagulation analyzer intended for in-vitro diagnostic use to analyze clotting, chromogenic and immuno-chemical methods in 3.2% Na citrated plasma in a clinical laboratory. No more than 2 venous blood draws will be attempted to obtain up to 4 whole blood specimens per subject, totaling no more than 30 mL. Samples may also be tested on the CS-5100 predicate comparator device.

This study will require 1 visit to Hershey Medical Center on a single day for up to two blood draws, no more than 2 tablespoons of blood (30 ml) total. The visit should last no more than 60 minutes and will be scheduled in advance with the study team. This visit will include signing a consent form to participate in the study, allowing the study team to draw your blood, and providing a small amount of information about yourself. We are looking for volunteers with coagulation disorders and healthy volunteers.

$75

The study will test GS-1427 for treatment of ulcerative colitis (UC). Adults diagnosed with UC can participate if otherwise eligible.The study has two parts; the first part lasts 12 weeks. Participants will be randomly assigned to either a treatment or a placebo arm. At 12-week evaluation the participants can be further assigned to an active treatment lasting 40 weeks. The second part of the study is for new participants. Eligible participants will be randomized to the treatment with GS-1427, Stelara, or both drugs.The study procedures include blood tests, endoscopy with biopsies, vitals, and physical exam, EKG testing, providing urine and stool samples, and completion of symptom-related diary questionnaires.

Participants will be required to sign the informed consent and show that they understand the study requirements. They will be required to complete in-person clinic visits. During the visits, the participants will have their vitals checked, and we will ask them about any problems they may have or adverse events. During the screening periods, participants will undergo endoscopy with biopsies and provide stool and urine samples. Blood draws will also be done, and we will teach them to complete the questionnaires about the disease symptoms. If eligible for the study, screened subjects will be randomized for either tone of the three drug dose or placebo treatment (blinded). They will attend at least five clinic visits over the twelve-week treatment period. At that time, the endoscopy evaluation will be done again, and the participants will be eligible to enter the next study phase. They will again be randomized to one of the four possible treatment arms using different drug doses. In the part 2, investigational drug, standard of care biologic Stelara, or concomitant treatment of both medicines. During part 2 of the study, subjects are required to attend at least ten clinic visits every four weeks. When the treatment is completed, the participants will be followed for four weeks and attend the end of the therapy visit. The final endoscopy will be done at week 52 of treatment. Participants will have an ECG done at selected study visits and a pregnancy check for WOCBA at every visit. Blood draws and a review the study diary will be done at every visit.

Part 1 total $1765 ($75 per visit, $20 meal cards v2 and v12); Part 2 TBD

This is a Phase 2 drug study, using a precision medicine approach to treat a chronic liver disease called Non-Alcoholic Steatohepatitis (NASH) in individuals at increased genetic risk for this condition. The primary objective of the study is to evaluate the effect of the study drug, ALN-HSD, on the histopathologic (liver biopsy) assessment of liver fibrosis. The study has a screening period of up to 16 weeks (day -113 to -1),a double-blind placebo-controlled treatment period of 52 weeks (day 1 to 365), and an off-drug safety follow-up period of 32 weeks (day 366 to 589). In total, the study duration is approximately 100 weeks.The study drug, or placebo, would be administered subcutaneously (through a fine needle in the belly) every 4 weeks, for a total of 13 doses. During the course of the study, there will be approximately 20 visits, which will take place in the clinical research center of our hospital. At these visits, participants will receive the injections, and be evaluated for vital signs, have regular bloodwork, receive a physical, and answer questions about their well being.

There will be up to 20 in person visits. The screening visits will include bloodwork, vitals, body measurements, and some additional scans. After randomization, each visit will occur approximately every two weeks and will include blood work and a physical at each visit, in addition to the administration of the study drug.

$2000