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Showing 1-20 of 108 trials
NCT05900037
This is a pre-market, prospective, randomized (1:1), multicenter, pivotal clinical investigation. The purpose of this investigation is to determine the clinical performance of GATT-Patch as compared with SURGICEL® Original for the management of minimal, mild, or moderate bleeding during minimally invasive liver and gallbladder surgery.
NCT04551742
The social determinants of health have a large impact on health. For example, neighborhood socioeconomic deprivation is associated with increased risk of medication non-adherence, graft failure, and death in children after liver transplant. In order to address these socioeconomic inequities in outcomes, a more granular understanding of how the social determinants of health impact outcomes is needed. In this observational prospective cohort, caregivers of children undergoing liver transplantation will complete surveys and undergo in-depth, qualitative interviews. The survey will assess comprehensively for the social determinants of health (e.g. material economic hardship, health literacy, social connectedness, primary care quality, etc). The qualitative interviews will identify barriers and facilitators that socioeconomically deprived children/families have to obtaining the ideal outcome and identify health system opportunities to integrate social needs and medical care. Data will be linked to an existing prospective cohort study (The Society for Pediatric Liver Transplant registry) to assess the impact of social risk on outcomes after transplant. Healthcare providers who take care of children undergoing liver transplant will also be included in the qualitative interviews. The goal of including this group in the study is to determine the health systems barriers and facilitators to social needs screening and intervention.
NCT04341012
The purpose of the study is to develop a clinical test based on breath analysis that can be used for disease diagnosis or prognosis.
NCT05264051
The purpose of the study is to study the muscle assessment score (MAsS, utilizing MRI, as an objective measure of frailty and muscle composition to serve as a predictor of morbidity and mortality in patients with liver disease.
NCT05740358
Liver Cirrhosis Network (LCN) Cohort Study is an observational study designed to identify risk factors and develop prediction models for risk of decompensation in adults with liver cirrhosis. LCN Cohort Study involves multiple institutions and an anticipated 1200 participants. Enrolled participants will have study visits every 6 months (180 days), with opportunities to complete specific visit components via telehealth or remotely. Visits will include collection of questionnaire data and the in-person visits will include questionnaires, physical exams, imaging, and sample collection.
NCT04618692
Comparison of biliary complications in right lobe living donor liver transplantation patients undergoing biliary reconstructions using microscope versus surgical loupes .
NCT04234139
The purpose of this study is to develop a clinical understanding of early liver transplantation (ELT) for patients with severe alcoholic hepatitis (SAH) and identify the public's opinion regarding this practice.
NCT06493773
To evaluate the efficacy of systematically offering newly diagnosed ALD patients to AUD treatment, in the hepatology clinic, on alcohol abstinence after 6 months. The investigators will conduct a randomized controlled superiority trial with parallel group design, hypothesis blinding and blinded outcome assessment comparing A) a offer to specialized AUD treatment (intervention) and B) standard care (control). Existing observational cohort ALD members will contribute to the control group in addition to the randomized controls. The primary outcome is abstinence throughout the last 30 days assessed 6 months after randomization.
NCT05790109
The goal of this study is to assess the physician and patient experience of radio frequency (RF) track cautery in patients undergoing needle biopsy of the liver, kidney, or spleen who have one or more risk factors for biopsy-related bleeding. RF track cautery involves inserting a bipolar electrode through the same introducer needle used for the biopsy, and heating the tissues along the path of the biopsy needle to prevent bleeding. This study primarily aims to assess the operator and patient experience during the use of track cautery. Secondary aims are to assess the technical success rate and procedure adverse events. Participants who enroll in the study will undergo track cautery as part of their clinically indicated liver, kidney, or spleen biopsy. After the procedure, they will fill out a brief survey asking about their experience during the procedure. Physician operators who perform track cautery as part of the study will also fill out a survey after each procedure asking about their experience using this technique.
NCT07111130
This is a prospective, single-arm, non-randomized interventional study nested within the existing ELEGANCE cohort. Patients eligible for the RE-BALANCE study will be selected from the ELEGANCE cohort based on predefined high-risk criteria, specifically a low 12-non-hydroxy/12-hydroxy bile acid ratio indicative of elevated hepatocarcinogenic risk. The study comprises Baseline Assessments (Visit 1), Intervention Visits (Visit 2-8), and Follow-up Assessments (Visit 9-11).
NCT05191446
The study consists of a randomized controlled trial evaluating the efficacy and feasibility of a stepped alcohol treatment using telemedicine on unhealthy alcohol use in patients with chronic liver disease receiving care in hepatology practices at three sites. Patients who meet eligibility criteria will be randomized to one of two study arms: 1) Stepped Alcohol Treatment (SAT) or, 2) Usual Care (UC). Participants will be randomized separately by site. SAT includes 3 sessions of motivational interviewing followed by referral to addiction medicine for patients who do not reduce unhealthy drinking. Trial outcome measures will be complete at 6 and 12 months following baseline enrollment.
NCT05282121
This study is open to adults with liver cirrhosis caused by hepatitis B, hepatitis C or nonalcoholic steatohepatitis (NASH). People can join this study if they have high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether a medicine called Avenciguat (BI 685509) taken alone or in combination with a medicine called empagliflozin helps people with this condition. Participants take Avenciguat (BI 685509) as tablets twice a day for 8 weeks. Half of the participants with NASH who also have type 2 diabetes take empagliflozin as tablets once a day in addition to Avenciguat (BI 685509). Participants are in the study for about 3 months. During this time, they visit the study site about 10 times. At 2 of the visits, the doctors check the pressure in a liver vein to see whether the treatment works. This is done with a catheter (a long thin tube) and gives information about the pressure in the portal vein. The doctors also regularly check participants' health and take note of any unwanted effects.
NCT07150624
A multicenter, open-label, randomized, controlled study. It is proposed to evaluate the treatment plan of receiving 930mg polyene phosphatidylcholine injection one day before the operation, twice a day, and 930mg polyene phosphatidylcholine injection twice a day,combined with 100mg of magnesium isoglycyrrhizinate injection once a day,from the 1st to the 5th day after the operation. Compared with the monotherapy regimen of no liver protection treatment before the operation and receiving magnesium isoglycyrrhizinate injection 100mg once a day from the 1st to the 5th day after the operation.The efficacy and safety of treating postoperative liver function injury in patients undergoing laparoscopic hemihepatectomy for hepatocellular carcinoma were compared.
NCT06133270
In this trial, medicine NNC0560-0004 given in capsule form will be compared to placebo in healthy volunteers. Participants will either get NNC0560-0004 or placebo. Which treatment they get is decided by chance. This is a first in human trial, which means that this is the first time that NNC0560-0004 is given to humans. The study will last for about two weeks plus the screening period (approximately 42 days) which in all is about 8 weeks. Women must be of non-childbearing potential thus you cannot take part if you are pregnant, can become pregnant, breast-feeding or plan to get pregnant during the study period.
NCT07125443
Liver transplantation remains the only cure for patients with end-stage liver disease. Despite continuous advances in medical care, ischemia-reperfusion injury (IRI) (tissue damage that occurs when blood supply is restored to an area that has been deprived of oxygen) remains a major contributor to complications with the newly transplanted liver. IRI can lead to a condition known as post-reperfusion syndrome that involves profound narrowing of blood vessels, significantly low blood pressure, and an increased requirement of medication to control blood pressure. In some cases, post-reperfusion syndrome can progress to a condition known as post-reperfusion vasoplegia which is a condition where severely low blood pressure persists even after blood flow is restored to the liver. This is often accompanied by complications such as improperly functioning kidneys, blood clotting disorders, and complications with the transplanted liver that can significantly affect patient outcomes. Recent studies have shown than inhaled nitric oxide (a gas that can relax blood vessels) can reduce the severity of IRI in the liver. This study is being conducted to determine whether the administration of inhaled nitric oxide during surgery reduces the severity of post-reperfusion syndrome and the incidence of post-reperfusion vasoplegia in adult patients undergoing liver transplantation. This is a before-and-after study design that will involve both the retrospective collection of data between the time period of January 1, 2020 - May 31, 2025 and prospective interventions involving adult liver transplant recipients.
NCT06692322
This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m\^2 can take part. Women can only participate if they cannot get pregnant. This study includes people with mild liver problems, people with moderate liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild and moderate liver problems affect how the body handles a medicine called zongertinib. Participants take zongertinib once as tablets. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study. Participants are in the study for about 5 weeks. During this time, they visit the study site 4 times. This also includes an overnight stay for 6 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the study staff regularly takes blood samples.
NCT04454463
The NAFLD Database 3 will enroll approximately 1500 adult patients and 750 pediatric patients suspected or known to have NAFLD or NASH-related cirrhosis. To elucidate, through the cooperative effort of a multidisciplinary and multicenter group of collaborators, the etiology, natural history, diagnosis, treatment, and prevention of NAFLD, and in particular its more severe form of NASH and its complications.
NCT07104786
This study was conducted on patients presenting to Mayo Hospital, Lahore from 24th August, 2023 till 23rd May, 2024. Ninety patients conforming to the inclusion criteria were selected via simple random sampling technique and divided into two groups. Group A received Obeticholic acid 10mg once a day and Group B received Vitamin E 400mg twice a day. Both treatments were given for 6 months alongwith clear written and informed instructions regarding lifestyle modification. Patients were followed at 3 and 6 months with ultrasound abdomen and serum alanine transferase levels.
NCT06144112
We compared the time consumed for goal-directed management of hypofibrinogemia using two strategies during liver transplant (LT) surgery: a conventional cryoprecipitate-based strategy versus a lyophilized fibrinogen concentrate-based strategy
NCT04483102
This is a prospective, non-randomized, clinical trial of discarded liver transplants that have received normothermic machine perfusion (NMP), compared with standard cold preservation liver transplants. The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study. Liver transplant outcomes will be ascertained during 12 months post-transplantation. The results of the trial will be compared with those of contemporary comparison groups of patients who received the standard criteria donor liver transplantation.