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 Phase III study to test whether survodutide (BI 456906) helps people with a liver disease called NASH/MASH who have cirrhosis. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with MASH and liver cirrhosis over a long-term treatment. To answer these questions, the study drug will be compared with a placebo. The overall study duration is approximately 4.5 years.

If you enroll in this study, you will undergo a series of testing. You will be asked to complete an initial assessment that includes a physical exam, vital signs, waist circumference, height, and weight measurements, questionnaires, blood draws, ECG, fibroscan, eye examination, and pregnancy test, if applicable, liver biopsy (if applicable). You will be randomized to either Survodutide once weekly or placebo (an inactive substance of no medical value). For treatment, you will be trained to inject yourself once a week with the study medicine. There will be up to 28 in person visits over 4.5 years study duration - to re-supply the study drug and copmlete safety testing. There will be up to 16 phone calls with the study staff.

up to $3,800 over 4,5 years

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.

This is a Phase 2 drug study, using a precision medicine approach to treat a chronic liver disease called Metabolic Dysfunction-Associated Steatohepatitis (MASH) 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 12 weeks (day -84 to -1) (which includes a genetic pre-screening assessment, 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.

$2548

This is Phase III study to test whether survodutide (BI 456906) helps people with a liver disease called NASH/MASH who have moderate or advanced liver fibrosis. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with MASH and liver fibrosis over a long-term treatment. To answer these questions, the study drug will be compared with a placebo. The overall study duration will be up to 7 years.

If you enroll in this study, you will undergo a series of testing. You will be asked to complete an initial assessment that includes a physical exam, vital signs, waist circumference, height, and weight measurements, questionnaires, a liver biopsy, blood draws, ECG, fibroscan, eye examination, and pregnancy test, if applicable. You will be randomized to either Survodutide once weekly or placebo (an inactive substance of no medical value). For treatment, you will be trained to inject yourself once a week with the study medicine. There will be 12 in person visits over the first year, and then - every 3 months within next 6 years - to re-supply the study drug and do safety testing. There will be up to 28 phone calls with the study staff.

$3,550 over 7 years

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 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

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 working At 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 samples During specific study visits during the treatment period the following tests will be performed: -An abdominal ultrasound -FibroScan -CT scans You will complete questionnaires.

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.

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 Objectives Efficacy: 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

Crohn's disease is a chronic, incurable inflammatory disease of the digestive system. Current treatment advancements need to be improved to meet patient's needs. This study is a 24-week treat-through design (meaning Induction and Maintenance treatment without re-randomization) using either monotherapy (single drug) or combination therapies (two drugs) in moderate to severe Crohn's disease. The participants who are responders will be able to continue treatment in Long Term Extension (LTE) study phase, weeks 24 to 96. This study aims to evaluate the safety and effectiveness of each combination therapy compared to conventional monotherapy.

Subjects will be required to sign the informed consent, and attend in person visits. They will be required to complete daily eDiary, and have tests and procedures done per protocol timeline. Procedures include blood tests, colonoscopies with biopsies, ECG, vitals and physical exam. Pregnancy testing will be done for WOCBP.

$77 per completed visit and $100 for completed endoscopy. Travel will be reimbursed up to $52 for each visit. You will be given $24 for meal if the visit required fasting.

This protocol has two independent parts. In Part 1, participants will be randomized to one of three Tulisokibart arms of treatment or placebo. Tretment will include induction, maintenance, and extension. When the maximum number of participants with prior exposure to advanced therapies has been reached, Part 2 will open for enrollment. In Part 2, the participants will be randomized to one of two dosing arms of Tulisokibart or a placebo.

The participants will be required to sign the inform consent and understand the requirements. They must have in person visits, comply with the procedures (blood test), colonoscopy, and to complete daily dairy about their symptoms. They must provide specimens such as blood, stool, and urine.

$100 per completed visit, $250 per endoscopy

RO7790121 will be used in the adult patients with Ulcerative colitis, to find out if it is safe and efficient in treatment of ulcerative colitis. The subjects will receive either RO7790121 drug or a placebo. After 12 weeks, the participants who complete treatment can continue to the open label treatment and receive a drug. Induction will consist of about eleven visits to the study site. The subjects will receive four intravenous treatments of either a drug or the placebo.

All subject must show understanding of the study requirements and sign the informed consent. The participants will have study procedures done, such as colonoscopy with biopsies, blood draws, and if eligible, they will be randomized at the start of induction treatment. The treatment will consists of the study drug or placebo. They will receive treatment by infusion in five study visits. After twelve weeks, the patience will be evaluated and they could continue to the open label treatment.

$75 per completed visits including endoscopy, and up to $50 for travel compensation for completed visit. You can receive a total of $1380.00 for your participation in the study.

This study will evaluate the safety and efficacy of a novel drug R07790121 compared to placebo in Crohn's disease patients. This drug is an antibody which binds to TL1A, a known important molecule in the regulation of Crohn's disease pathways. The patients who agree to participate and sign the informed consent, will receive a drug or placebo by intravenous infusion on days 0, 2, 6, and 10 of the Induction phase of treatment. During the Maintenance phase of treatment, weeks 12-52, the patients will be randomized to two doses of the drug or placebo that will be given by subcutaneous injection every four weeks. In the Open label phase of treatment, patients will receive the drug every two or every four weeks. All participants will have in-person clinic visits, will be asked to complete daily study questionnaires, provide specimens (stool, blood, urine), and have procedure done (endoscopy, ECG, blood work).

There are two screening visits to find out if subject is eligible to participate. The informed consent must be signed at the first visit, before any procedures. The subjects will be randomized for an induction treatment in two drug arms and one placebo (1:3). The Induction treatment will take 12 weeks and include five visits to the site. They may continue treatment into the Maintenance phase, weeks 12-52, There are ten visits, every four weeks. If disease returns or worsens, the subject may start the open label treatment during the maintenance. Each visit will have blood draws done, vitals check, and some have physical exam.

$75 per completed visit and $50 for travel. Total will depend on the number of visits completed

This is Phase III study to test whether efruxifermin (EFX) helps people with a liver disease called NASH/MASH who have moderate or advanced liver fibrosis. The purpose of the study is to find out whether the study drug works and how safe it is in participants diagnosed with MASH and liver fibrosis over a long-term treatment. To answer these questions, the study drug will be compared with a placebo. The overall study duration will be up to 5 years.

Your participation in the study will last about 4 years and 11 months which includes 3 months for screening procedures (to understand if you are eligible to participate in the study), 4 years and 7 months of study drug treatment and a 30-day follow up at the end of the study. This will involve up to 36 visits to your Study Doctor. During the study, you will be asked to inject a short needle into the soft tissue under the skin (subcutaneous) in the stomach or upper thigh once a week.

Up to $3,500 over the study duration (about 4 years 11 months)

This is a Phase 3, randomized, double-blind, placebo-controlled study evaluating the clinical benefit and safety of EFX in subjects with compensated cirrhosis due to NASH/MASH. The study will enroll in 2 cohorts. Cohort 1 will enroll approximately 750 subjects with biopsy-proven compensated cirrhosis due to NASH/MASH. Cohort 2 will enroll approximately 400 subjects with a clinical diagnosis of compensated cirrhosis due to NASH/MASH.

You will be required to visit the study clinic at specific times points. Laboratory and safety assessments will be completed at each visit. You will need to take the study drug as directed. Study procedures that will be performed include Liver Imaging scans, Liver Stiffness Exams, Electrocardiogram, Bloodwork, Liver Biopsy and an Endoscopy.

The study will investigate the role of standard medications for IBD on pregnancy outcomes. The subjects will be pregnant IBD patients receiving standard therapies. This study will also test whether the IBD medication transferred across placenta predicts the risk of infection. As many women receive these drugs during their reproductive years this information will guide future therapies for women with IBD and their children.

The participants will sign the informed consent. They will complete the questionnaires. There are four to five in the first year of pregnancy. After that, the questionnaires are annual, up to eighteen years after the birth of the child. The participants will have a blood sample done in the second trimester. They will send the sample to the sponsor.