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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are evaluating the efficacy and safety of pegozafermin in adults with compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis MASH, previously known as nonalcoholic steatohepatitis NASH. This study focuses on participants with biopsy-confirmed advanced liver fibrosis stage F4 due to MASH. The research aims to understand how pegozafermin affects liver health over time compared to a placebo. Participants will receive either pegozafermin or a matched placebo through subcutaneous injections. The study follows a randomized, parallel design with quadruple masking to ensure unbiased results. The treatment period extends up to 24 months, with additional long-term follow-up lasting up to five years to assess disease progression and liver fibrosis regression. During the study, participants will undergo various assessments including measurements of liver fibrosis, disease progression through clinical events, and liver function tests such as alanine aminotransferase ALT levels. Tools like Enhanced Liver Fibrosis ELF score and FibroScan Vibration-controlled Transient Elastography VCTE will be used to monitor liver condition up to 60 months. Safety and efficacy will be closely monitored throughout the study period, which may last up to seven years in total.

Age: 18Years - 75YearsAll GendersPhase 3
321 locations
E

Actively Recruiting

Healthy Volunteer

Researchers are evaluating fertiShare, a brief, evidence-based eLearning course designed to support fertility healthcare professionals in sharing bad news with their patients. The study aims to assess the feasibility of implementing fertiShare at fertility clinics and conducting a larger online randomized controlled trial to determine its effectiveness. This research addresses the challenges that fertility staff face when delivering difficult news, which can cause stress and impact patient trust and treatment continuation. The study is a pre-registered, online, multi-center, two-arm, triple-blinded feasibility randomized controlled trial. Participants are randomly assigned to either the fertiShare intervention group, which completes a two-hour self-led eLearning course organized into three modules focusing on sharing bad news and coping strategies, or to a control group receiving a basic communication skills eLearning course. The trial includes six UK-based fertility clinics and involves both fertility healthcare professionals and patients. Participants will be assessed through questionnaires measuring changes in patients perceptions of how staff share bad news, staff confidence, patient trust, satisfaction with care and decision-making, and treatment continuation. Data will be collected at baseline and follow-up timepoints, with some outcomes measured within one week of enrollment and others up to six months later. The study includes process evaluations and safety monitoring, with the total participation period varying by participant.

Age: 18Years +All GendersPhase Not Applicable
5 locations
U

Actively Recruiting

Researchers are conducting a prospective, observational study to assess the health of multiple organs in adults with type 2 diabetes who have no history of cardiovascular disease. The goal is to understand if detailed MRI measurements can help predict future clinical events over a 5-year period. Participants include adults diagnosed with type 2 diabetes, especially those diagnosed within the last three years. Participants will undergo no changes to their standard medical care. The study involves two main visits within one month the first includes body measurements and collection of blood and urine samples for routine diabetes checks, and the second involves a multi-organ, multiparametric MRI scan. Data from these visits, along with access to medical records, will be used to monitor disease progression and predict outcomes over 1, 3, and 5 years. Throughout the 5-year study, researchers will collect MRI metrics, clinical outcomes, and lab samples to evaluate diabetes progression. Participants consent to access their hospital and mortality records for event tracking. The primary outcome is the rate of major cardiovascular events three years after the baseline MRI. Secondary outcomes include kidney, eye, liver, cancer, and mortality events assessed at 1, 3, and 5 years. The study requires only a short period of active participation, with long-term follow-up through record review.

Age: 18Years +All Genders
12 locations