Almere

Researchers are evaluating the use of epigenome-guided treatment selection compared to the usual standard-of-care SOC treatment for adults with active Crohns Disease CD. This study aims to assess the effectiveness, safety, and cost-effectiveness of using an epigenetic biomarker assay and machine-learning software called EpiPredict to help choose between two biologic therapies, Vedolizumab VDZ and Ustekinumab UST, for treating active CD. The trial includes participants who have active disease and are either new to biologic therapy or have had limited prior biologic exposure. Participants will be randomly assigned to one of two groups one group will receive biologic treatment guided by the EpiPredict software based on epigenetic blood tests, which indicates the likelihood of response to VDZ or UST, while the other group will receive biologic therapy following usual SOC without epigenetic guidance. Both groups will receive their biologic therapy according to approved product labels, with dose adjustments allowed as needed by the treating doctor. Treatment and assessments will be carried out over 26 weeks, with different assessment schedules depending on the biologic received. After this treatment period, participants will have long-term follow-up every six months up to 24 months. During the study, participants will provide blood samples for epigenetic testing and undergo clinical and endoscopic evaluations to monitor their disease activity and response to treatment. Data will also be collected from routine medical records and online questionnaires during follow-up visits. The primary measurement is the comparison of clinical remission and endoscopic response rates at Week 26 between the two treatment selection methods. Researchers will also evaluate cost-effectiveness and explore how well the epigenetic assay predicts treatment success. Participants are required to comply with study procedures and provide informed consent to participate fully.

Researchers are evaluating orforglipron to measure its effects on cardiovascular outcomes in adults aged 50 and older who have atherosclerotic cardiovascular disease ASCVD andor chronic kidney disease CKD. This phase 3 study aims to compare orforglipron with a placebo to better understand its impact on major cardiovascular events over about five years. Participants will be randomly assigned to receive either orforglipron orally along with standard care or a placebo orally along with standard care. The study is double-blinded, meaning neither participants nor researchers will know who receives the active drug or placebo during the trial period. During the study, participants will be followed for around five years, with researchers monitoring the time to the first major cardiovascular event and additional outcomes such as cardiovascular and kidney events, changes in kidney function measured by eGFR, and the onset of type 2 diabetes. The study includes regular assessments to track these outcomes and ensure participant safety throughout the long-term follow-up.

Researchers are evaluating the safety and effectiveness of brenipatide at different dose levels compared with placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study aims to better understand how brenipatide may affect asthma symptoms and exacerbations over one year of treatment. Participants in this study are adults aged 18 to 75 years with a history of asthma and recent severe exacerbations. Participants will be randomly assigned to receive either one of two doses of brenipatide or a placebo, all administered by subcutaneous injection. The treatment period lasts 52 weeks, during which participants receive their assigned injections and are monitored regularly. The study includes a screening period before treatment and a follow-up period after treatment to assess ongoing safety and effects. During the study, participants will attend visits to complete questionnaires, lung function tests such as forced expiratory volume in one second FEV1, and assessments of asthma control and medication use. Researchers will monitor asthma exacerbation rates, rescue medication use, and the presence of anti-drug antibodies. The total study duration including screening, treatment, and follow-up is approximately 65 weeks.

Researchers are evaluating the effectiveness and safety of combining sonrotoclax with either obinutuzumab or rituximab compared to venetoclax plus rituximab in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL. This Phase 3 randomized study aims to understand which combination offers better progression-free survival and treatment outcomes in patients who have undergone prior therapies. The study has four treatment groups sonrotoclax combined with obinutuzumab, sonrotoclax combined with rituximab, sonrotoclax plus obinutuzumab with treatment guided by minimal residual disease evaluation, and venetoclax combined with rituximab. Sonrotoclax and venetoclax are given orally, while obinutuzumab and rituximab are administered intravenously. Participants receive these treatments according to their assigned group as part of this clinical research. Participants will be monitored for progression-free survival, overall survival, response rates, and minimal residual disease status over several months up to several years. Safety assessments include tracking treatment-emergent adverse events. Quality of life and symptom burden will be evaluated using questionnaires. The study involves regular visits for treatment administration and assessments, with follow-up extending up to 84 months to observe long-term outcomes.

Researchers are evaluating the effectiveness and safety of two fixed-duration treatment combinations for adults with previously untreated chronic lymphocytic leukemia CLL. The study compares sonrotoclax plus zanubrutinib with venetoclax plus acalabrutinib to determine which regimen may better manage this condition. This Phase 3 trial aims to provide insights into these oral therapies for CLL patients needing initial treatment. Participants will be randomly assigned to receive either sonrotoclax and zanubrutinib or venetoclax and acalabrutinib. Both treatment groups will follow a fixed duration of therapy, after which participants will be observed without active treatment. The study drugs are taken orally, and the treatment period is followed by a monitoring phase to evaluate ongoing health. During the study, participants will undergo evaluations including imaging tests to measure disease status and assessments of bone marrow and organ function. Researchers will track progression-free survival and minimal residual disease levels up to about 70 months. Other outcomes such as overall survival, response rates, adverse events, and quality of life will also be monitored. The total study duration extends until November 2031, offering long-term follow-up for participants.

Researchers are investigating how exercise might affect treatment outcomes for patients with metastatic colorectal cancer receiving chemotherapy. The study focuses on whether exercise can prevent changes to chemotherapy doses caused by toxicity, improve immune function, and enhance progression-free survival. It also seeks to identify the best type and amount of exercise for these benefits. This is a randomized, multi-arm trial using a Bayesian adaptive design to efficiently compare different exercise programs while minimizing patient exposure to less effective options. Participants are randomly assigned to one of three groups a resistance and continuous aerobic exercise group, an aerobic interval and continuous aerobic exercise group, or a usual care group. Those in the exercise groups engage in supervised moderate-to-high intensity sessions twice a week, plus a third session at home. The exercise includes activities like walking, cycling, and resistance exercises targeting large muscle groups. The usual care group receives standard treatment with exercise guidelines provided. The study uses several interim analyses to potentially stop less effective exercise arms early. During the study, participants undergo regular assessments including chemotherapy dose modifications, progression-free survival, immune cell function, hospitalization, treatment-related toxicities, fitness, muscle strength and mass, quality of life, fatigue, resilience, empowerment, and physical activity levels. These measures are taken from baseline through multiple chemotherapy cycles over several months, with outcomes monitored for up to two years. The study aims to better understand how exercise affects treatment effectiveness and patient well-being in metastatic colorectal cancer.

Researchers are evaluating the safety and effectiveness of NNC0487-0111 for treating adults with excess body weight. This phase 3 clinical trial compares weekly injections of NNC0487-0111 against placebo injections, both given under the skin. Participants also follow a reduced-calorie diet and increased physical activity as part of the study. Participants receive subcutaneous injections once a week of either NNC0487-0111 or a placebo. The study uses a randomized, parallel design with quadruple masking to assign treatments by chance. Treatments are given alongside lifestyle changes involving diet and exercise. During the trial, participants will be monitored over 92 weeks with regular assessments including body weight, waist circumference, blood pressure, blood sugar markers, cholesterol levels, and quality of life questionnaires. Safety is evaluated by tracking any adverse events. The primary measurement is the relative change in body weight from week 40 to week 92. The study is sponsored by Novo Nordisk AS and runs until mid-2028.

Researchers are investigating how the body absorbs essential amino acids after consuming two different dairy products full fat yogurt and full fat pasteurized milk. This randomized controlled trial aims to understand the early post-meal bioavailability of these amino acids in healthy adults aged 18 to 40 with a normal to slightly overweight body mass index. The study is sponsored by Nutricia Research and focuses on measuring amino acid levels in the blood after product intake. Participants will visit the study site twice while fasting. During each visit, they will consume one serving of either the yogurt or milk product in a random order within about 10 minutes. Blood samples will be collected before consumption and at 14 timepoints afterward to track amino acid levels over time. After the final visit, a follow-up call will be made within about a week to check on participants. Throughout the study, researchers will measure the incremental area under the curve for essential and total amino acids in blood over periods of 2 and 5 hours, along with the maximum concentration achieved. Participants will undergo blood sampling at multiple timepoints to provide detailed data on amino acid absorption. The total duration of participation includes the two study visits and the follow-up call, ensuring close monitoring and data collection to evaluate the bioavailability of the products.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are investigating chronic fatigue, a common and complex symptom affecting about 30% of people in the Netherlands for over six months. The study aims to find out how often diagnostic tests during fatigue consultations at an internal medicine outpatient clinic lead to a somatic diagnosis and to understand the experiences of patients who do not receive a diagnosis after such consultations. This mixed-method study combines reviewing past medical records and conducting interviews to explore patient perspectives. The research includes two parts a retrospective analysis of electronic health records to evaluate the outcomes of diagnostic procedures like blood work, ECG, and chest X-rays during fatigue consultations and a prospective qualitative study where patients with unexplained fatigue are interviewed about their experiences shortly after their clinic visit and again 6 and 12 months later. The interviews follow an open, exploratory approach based on Grounded Theory. Participants will be adults referred for fatigue at the internal medicine outpatient clinic. Data will be collected on diagnostic test results and patient experiences through interviews. The study will measure outcomes such as blood test, ECG, and chest X-ray results within two weeks of consultation, and patient experiences at multiple time points up to one year after their visit. The findings aim to improve diagnostic approaches and patient care for those with chronic fatigue.