Dirksland

Researchers are evaluating the safety and effects of a new medicine called NNC0487-0111 in people who have Heart Failure with preserved Ejection Fraction HFpEF or Heart Failure with mildly reduced Ejection Fraction HFmrEF and excess body weight. This phase 3 clinical trial aims to find out if NNC0487-0111 is safe and effective for treating these conditions compared to a placebo. Participants have HFpEF or HFmrEF and a body mass index of 30 or above. The study is sponsored by Novo Nordisk AS and uses a randomized, quadruple-masked design. Participants will receive either NNC0487-0111 or a matching placebo by injection under the skin once a week. The NNC0487-0111 is given in increasing doses over time. The study is parallel in design, meaning participants are randomly assigned to one of the two groups and receive that treatment throughout the trial. This treatment period extends for up to about 165 weeks. The study evaluates the time to certain heart failure events, hospitalizations, cardiovascular deaths, and other major cardiovascular events. During the study, participants will be monitored regularly to assess heart failure outcomes and kidney function, as well as quality of life using questionnaires like the Kansas City Cardiomyopathy Questionnaire. Safety and effectiveness are assessed through hospital visits, heart failure event tracking, and blood tests including kidney function and blood sugar levels. The total participation spans over three years, with ongoing evaluations to measure the time to heart failure events and cardiovascular outcomes. Participants receive close medical monitoring throughout the study period.

Researchers are evaluating camizestrant against standard endocrine therapy for patients with ER-positive, HER2-negative early breast cancer who have an intermediate or high risk of disease recurrence. These patients must have completed locoregional therapy and at least 2 to 5 years of standard adjuvant endocrine therapy. The study is a Phase III open-label trial focused on improving outcomes for these patients over a long-term period. Participants are randomly assigned to receive either camizestrant orally or continue with the standard endocrine therapy chosen by their investigator, which may include aromatase inhibitors exemestane, letrozole, anastrozole or tamoxifen. Treatment in each group lasts for 60 months. The study allows prior use of CDK46 inhibitors and includes a follow-up period extending up to 10 years from the last patient randomization. During the study, participants will undergo regular assessments to monitor invasive breast cancer-free survival and other outcomes such as invasive disease-free survival, distant relapse-free survival, overall survival, and safety. Researchers will also evaluate symptoms like joint pain, hot flushes, and vaginal dryness using specific scales, along with quality of life measures and pharmacokinetics. Safety monitoring continues up to 28 days after the last dose, and participants remain under observation for up to 10 years total.

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 investigating the effectiveness of adding liothyronine LT3 to levothyroxine LT4 treatment in patients with autoimmune hypothyroidism who continue to experience severe tiredness despite having normalized thyroid hormone levels on LT4 alone. This study addresses the problem that LT4 monotherapy may not fully replicate the natural balance of thyroid hormones, as healthy individuals produce some T3 directly. The trial also explores whether certain genetic factors influence response to combination therapy. The study begins with a run-in period where all participants switch to a standardized generic LT4 to stabilize thyroid hormone levels. After confirming normal TSH levels and persistent tiredness, participants enter a one-year randomized, double-blind trial comparing LT4LT3 combination therapy to LT4 with placebo. The LT4LT3 group takes LT4 once daily and LT3 twice daily at a set ratio. Visits occur at baseline and multiple times over the year to adjust doses and monitor health. Participants undergo physical exams, ECGs, blood tests, and complete questionnaires about tiredness, quality of life, and medical resource use throughout the study. Additional measures include bone markers, scans, cardiovascular and metabolic assessments, and neurocognitive tests in subgroups. The main outcome is the change in tiredness scores over 52 weeks, with safety and genetic factors also evaluated. The total study duration includes the run-in and treatment phases, lasting several months to over a year.

Researchers are studying women with node-positive breast cancer who receive neoadjuvant systemic therapy NST, which includes chemotherapy with or without immunotherapy. The study aims to understand the safety and quality of life effects of using less invasive methods compared to more invasive axillary staging and treatment after NST. This is important because patients whose lymph nodes show no remaining cancer after NST may not benefit from extensive lymph node removal, but more evidence is needed about the safety and impact of less invasive approaches. This multicenter observational study collects detailed information on patients treated with NST for node-positive breast cancer. It gathers data about the cancer, staging methods before and after NST, and treatment details from medical records. Patients complete questionnaires about their quality of life at diagnosis, and then 1 and 5 years later. The study database is maintained by the Netherlands Cancer Registry and aims to inform future treatment guidelines. Participants provide information through patient-reported outcome measures and undergo regular clinical follow-up to monitor disease-free survival, breast cancer-specific survival, overall survival, and rates of cancer recurrence in the lymph nodes over five years. Quality of life is assessed using several validated tools at baseline and during follow-up. The study results will help balance treatment decisions between less and more invasive options and support shared decision making for women with this breast cancer type.

Researchers are investigating how various factors beyond tumor stage, such as biochemical, histopathological, genomic, environmental, and clinical characteristics, affect the outcomes of patients diagnosed with colorectal cancer CRC, small bowel cancer, and anal cancer. This observational study aims to collect detailed information from diagnosis through long-term follow-up to better understand prognosis and treatment effects in both early and late-stage cancers. The study addresses the gap between clinical trial populations and real-world patients by including a broader patient group treated in general practice. Participants will be followed prospectively from their initial diagnosis until death. Data collection includes medical history, clinical parameters, imaging, pathology, tumor details, treatments, hospital stays, interventions, and adverse events. With separate consent, patient-reported quality of life and work ability information will also be gathered. Additionally, biological samples obtained during routine care may be collected for further observational and molecular research. This cohort serves as a platform for evaluating new interventions through a Trials within Cohorts TwiCs design. Throughout up to ten years of follow-up, participants will undergo assessments of progression-free survival, disease-free survival, overall survival, and serious adverse events. Quality of life and work ability are assessed at intervals of 3, 6, 12, 24, 36, and 48 months. This extensive data collection supports a wide range of research aims including prognostic studies, molecular analyses, comparisons of new treatments, and health policy evaluations. The study provides a comprehensive view of treatment outcomes and patient experiences in everyday clinical settings.

Researchers are studying the effect of at-home taste steering compared to standard care on food enjoyment in patients with metastatic triple negative breast cancer, metastatic testicular cancer, or stage II-IV diffuse large B cell lymphoma who are undergoing chemotherapy. This multicentre randomized intervention trial uses a parallel cluster design across 12 hospitals in the Netherlands to prevent bias from patient contact within the same hospital. The study measures outcomes before chemotherapy begins, at the onset of taste or smell alterations, and after 6 weeks. Participants in the experimental group will use taste steering techniques at home while the control group receives usual care. Questionnaires are completed online from home, and taste and smell tests plus saliva collection are done either at home or during regular hospital visits. Both groups will have contact with their dietitian every 3 weeks. The intervention lasts 6 weeks, based on prior experience indicating the taste steering algorithm saturates after 3-4 weeks. During the study, participants will complete assessments of food enjoyment, health-related quality of life, taste and smell function, saliva secretion, and body weight. These are measured at baseline, at the time taste or smell changes occur, and after 6 weeks. Researchers will also monitor risk of malnutrition and dry mouth feeling. The total participation period covers the 6-week intervention and associated follow-up assessments.

Researchers are evaluating the impact of at-home taste and smell training compared to standard care in patients with cancer treated with tyrosine kinase inhibitors. This multicenter randomized intervention trial involves 12 hospitals in the Netherlands and aims to understand how this training affects taste function and other related outcomes over 12 weeks. The study uses a parallel cluster design to avoid bias by keeping treatment groups separate within each hospital. Participants are assigned to either perform taste and smell training at home or receive usual care without the training. Measurements are taken at baseline and after 12 weeks, including taste and smell tests, saliva collection, and online questionnaires completed at home. Dietitians contact patients every 3 weeks in both groups to support adherence and monitor progress. During the study, participants undergo assessments of taste and smell function, food enjoyment, quality of life, risk of malnutrition, dry mouth sensation, saliva secretion, and body weight. These evaluations occur at home or during regular hospital visits. The total duration for each participant is approximately 12 weeks, during which researchers track changes and safety related to the interventions.